Intervention Review

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Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures

  1. Paul Kinnersley1,*,
  2. Katie Phillips1,
  3. Katherine Savage1,
  4. Mark J Kelly2,
  5. Elinor Farrell1,
  6. Ben Morgan1,
  7. Robert Whistance3,
  8. Vicky Lewis4,
  9. Mala K Mann5,
  10. Bethan L Stephens1,
  11. Jane Blazeby6,
  12. Glyn Elwyn1,
  13. Adrian GK Edwards1

Editorial Group: Cochrane Consumers and Communication Group

Published Online: 6 JUL 2013

Assessed as up-to-date: 17 JUL 2012

DOI: 10.1002/14651858.CD009445.pub2


How to Cite

Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AGK. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD009445. DOI: 10.1002/14651858.CD009445.pub2.

Author Information

  1. 1

    Cardiff University, Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff, Wales, UK

  2. 2

    Cardiff University, South East Wales Trials Unit, Institute of Translation, Innovation, Methodology and Engagement, Cardiff, Wales, UK

  3. 3

    University of Bristol, Academic Unit of Surgical Research, School of Social and Community Medicine, Bristol, UK

  4. 4

    Wales Deanery for Postgraduate Medical and Dental Education, Cardiff, Wales, UK

  5. 5

    Information Services, Cardiff University, Support Unit for Research Evidence (SURE), Cardiff, Wales, UK

  6. 6

    University of Bristol, Section of Healthcare Research, The School of Social and Community Medicine, Bristol, UK

*Paul Kinnersley, Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff University, 3rd Floor, Neuadd Meirionnydd, Heath Park, Cardiff, Wales, CF14 4XN, UK. kinnersley@cf.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 6 JUL 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Agre 1994a

MethodsSingle-centre RCT

Three armed trial

Data analysed for each intervention separately

Presented in this table is information for Intervention A


Participants201 patients attending for endoscopy

Recruited between 18 March and 21 October 1992

New York, USA

Numbers of participants in analysis: 99

Intervention: 66

Control: 33 (the control group was split between the two arms of this study)


InterventionsIntervention A: Audio-visual, non-interactive 5 minute video designed for the trial (approved by 5 endoscopy/GI specialists), same content as standardised oral discussion but with graphics to aid explanation

Intervention development: designed for the trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control group characteristics:verbal consent with a check list to ensure all points covered

Done with clinician?: distant without clinician

Intervention type: audiovisual

Time of delivery: on admission


OutcomesImmediate knowledge: continuous data reported

13-item MCQ (validated in the department through edits by the clinicians working there and then asking 50 patients to pilot who were having colonoscopy) completed 10 minutes after consent signed for procedure

Anxiety with consent process: from STAI questionnaire measured 10 minutes after consent - insufficient data reported to permit analysis


NotesAim: to examine the role of videotape in increasing patients' knowledge in preparation for informed consent and to examine whether an increase in knowledge resulted in increased anxiety

Conclusion: knowledge improved for intervention A with no significant increase in anxiety


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient details: random envelopes prepared by 'Department of Biostats'

Allocation concealment (selection bias)Unclear riskInsufficient details: no details on concealment

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants not blinded, unclear whether clinicians blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient details: no details of blinding

Agre 1994b

MethodsSingle-centre RCT

Three armed trial

Data analysed for each intervention separately

Presented in this table is information for Intervention B


Participants201 patients attending for endoscopy

Recruited between 18 March and 21 October 1992

New York, USA

Numbers of participants in analysis:101

Intervention: 68

Control: 33 (the control group was split between the two arms of this study)


InterventionsIntervention B: Interactive multimedia: 5 minute video designed for the trial (approved by 5 endoscopy/GI specialists), same content as standardised oral discussion but with graphics to aid explanation on the video and time given with the endoscopist for further explanation

Intervention development: designed for the trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention:no details

Evaluation of the delivery of intervention: no details

Control group characteristics:verbal consent with a check list to ensure all points covered

Done with clinician?: face to face

Intervention type: interactive multimedia

Time of delivery: on admission


OutcomesImmediate knowledge: continuous data reported

13-item MCQ (validated in the department through edits by the clinicians working there and then asking 50 patients to pilot who were having colonoscopy) completed 10 minutes after consent signed for procedure

Anxiety with consent process: from STAI questionnaire measured 10 minutes after consent - insufficient data reported to permit analysis


NotesAim: to examine the role of videotape in increasing patients' knowledge in preparation for informed consent and to examine whether an increase in knowledge resulted in increased anxiety

Conclusion: knowledge improved for intervention B with no significant increase in anxiety


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient details: random envelopes prepared by 'Department of Biostats'

Allocation concealment (selection bias)Unclear riskInsufficient details: no details on concealment

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants not blinded, unclear whether clinicians blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient details: no details of blinding

Armstrong 1997

MethodsRCT comparing usual (verbal) consent to showing patient a list of potential side-effects for cosmetic, hand and minor skin tumour surgery


ParticipantsPatients undergoing cosmetic surgery/elective hand surgery/excision of minor skin tumours

Sheffield, United Kingdom

Numbers of participants in analysis: 269

Intervention: 137

Control: 132


InterventionsWritten information sheet with lists of 7 risks, signed by patient to confirm understanding and retained in patient's notes

Intervention development: no details

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesShort-term knowledge: Recall of risks recorded in post-op interview by nurse experienced in plastic surgery, at mean of 9 days post surgery (data extracted on recall of “Wound” taken from table 5, this was the median effect size), dichotomous data


NotesAim: To determine if written pre-operative warnings about risks of surgery improve patients recall of risks post-operatively compared with a group given verbal warning alone

Conclusion: Post-op recall of patients given written warning sheets was improved, although the relevance of the difference in recall between the two groups of fewer than 1 warning is debatable


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskOdd/even hospital numbers - quasi-randomisation

Allocation concealment (selection bias)High riskAllocation predictable because of method of random sequence generation

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome measured by nurse who was blinded to allocation

Armstrong 2010

MethodsRCT to evaluate the effectiveness of video information on patients' immediate knowledge for either punch or shave biopsy


ParticipantsPatients attending a dermatology clinic from July 2009 to February 2010

USA

Numbers of participants in analysis: 84

Intervention: 42

Control: 42


InterventionsDermatologists used an MP3 video (3.5 screen-ipod touch or iphone 3) to show an education video detailing the 3 aspects of a skin biopsy

Intervention development: no detail

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: audio-visual

Time of delivery: on admission


OutcomesImmediate knowledge


NotesAim: to determine if a video-based education delivered through mobile, video devices improves patient knowledge and satisfaction in the informed consent and post op educational processes compared with conventional verbal instruction

Conclusion: study demonstrated a significant increase in knowledge score following video education, but not following oral education. Although group comparisons did not achieve statistical significant, portable video media for presenting informed consent and wound care instructions for skin biopsies appear to be more effective and result in higher satisfaction than traditional oral education


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPerformed using the Graphpad Prism 2009 statistical software

Allocation concealment (selection bias)Low riskGroup allocation sequence was kept in sealed envelopes until each participant was ready to be randomised

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Low riskProtocol published and checked for consistency, all outcomes reported

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskUnclear if participants knew that they were in a study or not

Dermatologists were aware of group allocation

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAuthor email reply states outcome measurement blinded, stated outcome measurement researcher blinded to randomisation

Ashraff 2006

MethodsRTC - 2 groups, leaflet posted 2 weeks before admission, recall of information tested at admission


ParticipantsElective orthopaedic patients under going THR, TKR, knee arthroscopy, shoulder surgery inc shoulder decompression, shoulder replacement and Bankarts Repair

Numbers of participants in analysis: 110

Intervention: 57

Control: 53


InterventionsA4 information leaflet post 2 weeks prior to admission, describing operation and included a list of complications and information re post op care such as length of stay and return to work

Intervention development: no details

Exposure: once

Training for delivery of intervention: non needed

Evaluation of the delivery of intervention: no details

Control group characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesShort-term knowledge: score out of 10, assessed on admission to the ward, 2 weeks after receiving the leaflet


NotesAim: to determine whether patient information leaflets help to improve patient recall during the process of informed consent

Conclusion: patient information leaflets are a useful tool for the surgeon to improve the recall of the information given to the patient, in order to facilitate informed consent

Author contacted: yes, no further data available


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated number table

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuestionnaire, but unclear if anonymously assessed

Insufficient detail

Astley 2008a

Methods3 armed randomised controlled trial

Data analysed for each intervention separately

Presented in this table is information for Intervention A (written information)


ParticipantsPatients were undergoing coronary angiography. All completed primary end point, immediately after procedure (> 4hrs and < 24hrs), but 10 were lost to follow-up at 30 days and 2 died before 30 day follow-up (from the three arms)

Australia

Numbers of participants in analysis: 50

Intervention: 34

Control: 16


InterventionsContent of all interventions standardised by a coronary angiogram risk pro forma, developed at Flinders medical centre with input from the cardiology and cardiac surgery departments. This formed checklist for verbal, text for written and script for audio visual technique

After receiving information, followed up by doctor who asked for and fielded questions from the patient, prior to consent

Prior to the patient signing the consent form the same doctor verbally explained the process of coronary angioplasty and stenting in case this intervention became part of the same procedure

Intervention development: designed for the trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control group characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesImmediate, short-term, long-term knowledge: assessed at < 4 hrs, 4 to 24 hours and 30 days (median score out of 12) non-parametric data

Satisfaction with the consent process: assessed at < 4 hrs, 4 to 24 hours and 30 days (5 point Likert scale, 5 = satisfied)

Anxiety with the consent process: assessed at < 4 hrs, 4 to 24 hours and 30 days (5 point Likert scale 5 = anxious)


NotesAim: to compare verbal, written and animated audiovisual information prior to coronary angiography by assessing risk recall, satisfaction and anxiety

Conclusion: interventions had no effect on recall, anxiety or satisfaction


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients randomised in 1:1:1 ratio

Balanced randomisation generated via computer program

Allocation concealment (selection bias)Low riskComputer print-out enabled study staff to implement next allocation in sequence, research subjects and staff were unable to view print-out

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll completed primary outcome of recall post procedure

10 lost to follow up at 30 days and 2 died; attrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and clinicians were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Outcomes data collected by 2 trained study staff from the Flinders Medical Centre, cardiovascular outcomes research unit, unclear if blinded

Astley 2008b

Methods3 armed randomised controlled trial

Data analysed for each intervention separately

Presented in this table is information for Intervention B (audiovisual information)


ParticipantsPatients were undergoing coronary angiography. All completed primary end point, immediately after procedure (> 4hrs and < 24hrs), but 10 were lost to follow-up at 30 days and 2 died before 30 day follow-up (from the three arms)

Australia

Numbers of participants in analysis: 49

Intervention: 33

Control: 16


InterventionsContent of all interventions standardised by a coronary angiogram risk pro forma, developed at Flinders medical centre with input from the cardiology and cardiac surgery departments. This formed checklist for verbal, text for written and script for audio visual technique

Audiovisual video was produced at Flinders medical centre and designed to include four types of memory cues: photographic explanation, demonstration, animation, and bullet point text

After receiving information, followed up by doctor who asked for and fielded questions from the patient, prior to consent

Prior to the patient signing the consent form the same doctor verbally explained the process of coronary angioplasty and stenting in case this intervention became part of the same procedure

Intervention development: designed for the trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: audiovisual

Time of delivery: on admission


OutcomesImmediate, short-term, long-term knowledge: assessed at < 4 hrs, 4 to 24 hours and 30 days (median score out of 12) non-parametric data

Satisfaction with the consent process: assessed at < 4 hrs, 4 to 24 hours and 30 days (5 point Likert scale , 5 = satisfied)

Anxiety with the consent process: assessed at < 4 hrs, 4 to 24 hours and 30 days (5 point Likert scale 5 = anxious)


NotesAim: to compare verbal, written and animated audiovisual information prior to coronary angiography by assessing risk recall, satisfaction and anxiety

Conclusion: interventions had no effect on recall, anxiety or satisfaction


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients randomised in 1:1:1 ratio

Balanced randomisation generated via computer program

Allocation concealment (selection bias)Low riskComputer print-out enabled study staff to implement next allocation in sequence, research subjects and staff were unable to view print-out

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll completed primary outcome of recall post procedure

0 lost to follow up at 30 days and 2 died; attrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and clinicians were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Outcomes data collected by 2 trained study staff from the Flinders Medical Centre, Cardiovascular outcomes research unit, unclear if blinded

Bekker 2004

MethodsRCT evaluating decision analysis for Down Syndrome screening, measuring outcomes immediately after intervention and one month later


ParticipantsPregnant mothers having received a positive (> 1 in 250) maternal serum screening test (MSS) over a 15 month period

Leeds, United Kingdom

178 assessed for eligibility, of whom 46 not eligible & 15 declined; 117 randomised, intervention 59, control 58 (See incomplete outcome section of risk of bias table for further details regarding attrition rates)

Numbers of participants in analysis: 106

Intervention: 50

Control: 56


InterventionsRoutine information, plus decisional analysis consisting of 3 components

  1. A decision tree representing test options and consequences
  2. A prompt eliciting a global utility to determine the patients maximum tolerated risk of Down Syndrome before considering Termination of Pregnancy
  3. A threshold graph integrating this utility and the MSS risk figure


Intervention development: designed for the trial with no validation

Exposure: once

Training for delivery of intervention: all delivered by key researcher

Evaluation of the delivery of intervention: no details

Control group characteristics: verbal consent

Done with clinician?: face to face

Intervention type: decision aid

Time of delivery: before admission


OutcomesDeliberation: 'seeking information' score from coding of themes from consultation transcripts. 'Seek info' outcome used which is on scale 0 to 7, higher score is ‘good’

Immediate knowledge: MCQ questionnaire immediately after initial consultation (after intervention)

Long-term knowledge: MCQ questionnaire at one month follow-up (after results of further investigations have been given to patient)

Satisfaction with decision making: 'effective' arm of decisional conflict score, at 1 month follow-up

Length of consultation: initial consultation

Rates of uptake: patients' notes checked for diagnostic test results

Generalised anxiety: short form STAI (20-80, low-high anxiety), measured at initial appointment

Satisfaction with consent process: "overall, how useful was the information given during this consultation?", measured at initial consultation and at follow-up at 1 month following receipt of results of diagnostic tests. Initial consultation assessed to be appropriate measure for our review as closer in time to intervention, and less effected by results of diagnostic tests.


NotesAim: to evaluate decisional analysis as a technique to facilitate women's decision making about prenatal diagnosis for Down Syndrome using measures of effective decision making

Conclusion: decision analysis consultations enabled women to make more informed prenatal diagnosis decisions. Informed decision making was higher, perceived risk more realistic, and decisional conflict lower in the intervention group. Intervention had no impact on knowledge or subjective expected utility scores, and was no more or less directive, useful or anxiety provoking than control. Consultations were six minutes longer in intervention group

Author contacted: yes, data used for Risk of Bias table


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients were randomly allocated.The method of randomisation was a random number generator programme (SPSS) carried out in blocks of 10

Allocation concealment (selection bias)Low riskPreviously numbered, sealed opaque envelopes

Incomplete outcome data (attrition bias)
All outcomes
Low riskFull details on this in data - exclusion between randomisation and time 1 (T1) was 15% in intervention, 3% in control. Attrition rate at 1 month (T2) was 42% in intervention, 30% in control. Fully documented and analysed with no statistical difference between return rates in groups Overall attrition not > 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants not told which consultation was routine. Personnel not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuestionnaires were completed by patients without the researcher present. The questionnaires were entered onto the computer with their study number identified. At the final stage of analysis, the SN and arm allocation were matched to reveal the trial group

Bennett 2009a

MethodsRCT with two intervention arms (teach-the-teacher/diagrams) and one control

Data analysed for each intervention separately versus half of the control group

Presented in this table is information for Intervention A versus Control group

This entry is for Intervention A: TEACH THE TEACHER group


Participants109 eligible participants, 10 declined, therefore 99 patients undergoing a spinal injection (epidural steroid, nerve root or facet joint injection) in musculoskeletal radiology.

Iowa, USA

Numbers of participants in analysis: 50

Intervention: 34

Control: 16 (half the number of total control group to allow for analysis of each intervention arm)


InterventionsIntervention A: Teach the teacher group, had to verbally repeat the twelve key points without error to the physician before the patient could sign the informed consent form

Intervention development:designed for trial with no validation

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: no details

Control group characteristics: verbal consent and used a checklist

Done with clinician?: face-to-face

Intervention type: decision aid

Time of delivery: on admission


OutcomesImmediate knowledge: MCQ scored out of 10, with negative marking

Length of consultation: time in minutes

Generalised anxiety: after procedure, patients asked to rank calmness from 1 to 10 (1 = completely calm). Lacking data to derive SDs from data, therefore information cannot be used in the meta-analysis. TTT 3/10, control 2/10.

Pain: after procedure, patients asked to rank during the procedure from 1 to 10 (1 = no pain). Cannot include in the meta-analysis with not enough raw data available. Control 2/10, TTT 2/10. On a scale of 1 to 10 with 1 being completely painless.


NotesAim: a method using diagrams will improve patient-physician communication without increasing the time required to obtain informed consent over the teach the teacher method as well as over current informed consent protocol.

Conclusion: diagram method was most successful requiring less time than the teach the teacher method and had no negative correlation with age, and had improved survey scores over the control group.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskResearch assistant randomly assigned patient to groups in a rotatory basis

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Bennett 2009b

MethodsRCT with two intervention arms (teach-the-teacher/diagrams) and one control.

Data analysed for each intervention separately versus half of the control group.

Presented in this table is information for Intervention B versus Control group.

This entry is for Intervention B: Diagram group.


Participants109 eligible participants, 10 declined, therefore 99 patients undergoing a spinal injection (epidural steroid, nerve root or facet joint injection) in musculoskeletal radiology.

Iowa, USA

Numbers of participants in analysis: 48

Intervention: 32

Control: 16 (half of the total control group)


InterventionsIntervention B: Diagram group viewed a set of diagrams illustrating the twelve key points before signing the informed consent form.

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: no details

Control group characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesImmediate knowledge: MCQ scored out of 10, with negative marking

Length of consultation: time in minutes

Generalised anxiety: after procedure, patients asked to rank calmness from 1 to 10 (1 = completely calm). Lacking data to derive SDs, therefore information cannot be used in the meta-analysis. Diagram and control group both scored 2/10.

Pain: after procedure, patients asked to rank during the procedure from 1 to 10 (1 = no pain). Cannot include in the meta-analysis with insufficient raw data. Control 2/10, diagram 3/10.


NotesAim: a method using diagrams will improve patient-physician communication without increasing the time required to obtain informed consent over the teach the teacher method as well as over current informed consent protocol.

Conclusion: diagram method was most successful requiring less time than the teach the teacher method and had no negative correlation with age, and had improved survey scores over the control group.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskResearch assistant randomly assigned patient to groups in a rotatory basis

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Bollschweiler 2008

Methods4-centre RCT comparing standard methods of consent to the addition of a multimedia program to aid consent for laparoscopic cholecystectomy.


Participants80 patients were recruited and 76 randomised to intervention or control. Patients attending 1 of 4 hospitals were randomised usually day before surgery to either group. Different levels of education between 2 groups were noted and therefore were not comparable at baseline

Germany

Numbers of participants in analysis: 76

Intervention: 35

Control: 41


InterventionsComputer program (MM-IP) which was developed over 3 years by a team of medics, linguist and psychologists and evaluated by patients and staff. High quality. Based on powerpoint, with progressive levels of information for patients from easy to harder.

Intervention development: designed for trial with reasonable effort for validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent and used a special leaflet

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: on admission


OutcomesAfter informed consent process completed, questionnaires were given to both groups. No details of timing

Self-report of understanding: of general information and risks of surgery, using a previously validated tool (VAS validated version). The report asked 8 questions of self-perceived knowledge and it is difficult to take an average score. The paper summed the total and used this in secondary analysis against education scores - mean and SD of each group's total score not available in report

Satisfaction with consent process: evaluated using VAS (also validated) scores

Statistics note for satisfaction with consent process - took question 1 as representative and most relevant

General anxiety: with the process, measured after consent process using KASA scores (also validated)

Statistics note for general anxiety - SDs obtained from SEM


NotesAim: patients' perception of their understanding of important aspects of their illness (disease, therapeutic alternatives, operation, risks) and satisfaction with the consenting process

Conclusion: before an elective procedure, patients using an MM-IP as a supplement to the traditional informed consent process feel better informed about their disease and its treatment than patients going through the traditional consent process alone. Improved patient understanding of illness is the basis of the informed consent process. Personal consultation with the physician and written informed consent remains indispensable to this process


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentral allocation, random list

Allocation concealment (selection bias)Low riskCentrally allocated, random process

Incomplete outcome data (attrition bias)
All outcomes
Low riskLow attrition rate (lost 4/80)

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskGroups not comparable for education level, not accounted for in analysis

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Chan 2002

MethodsRCT comparing written information with illustrations plus usual consent to usual consent alone.


Participants125 consecutive patients of greater than 16 years of age, who were undergoing thyroidectomy or parotidectomy. Four patients excluded from analysis as lost to follow-up

Toronto, Canada

Numbers of participants in analysis: 121

Intervention: 56

Control: 65


InterventionsIntervention: an information leaflet with written information and illustrations plus usual consent.

Control: Usual consent whereby surgeons were given a specific checklist of risks to outline to the patient according to the planned surgical procedure with an equal emphasis on each risk. During the consent process in both groups any additional questions from patients were answered and patients were asked to sign a standard surgical consent document.

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesLong-term knowledge: Average rate of risk recall - performed 3 to 7 weeks after consultation by telephone interview where patients were asked to recall specific risks of their operation. Thyroidectomy scored out of 3, parotidectomy scored out of 4


NotesAim: to examine the effects of an educational intervention on patient knowledge and recall of possible risks from parotidectomy or thyroidectomy.

Conclusion: study found that a patient's ability to recall potential complications of surgery was significantly increased by the intervention


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail. Patients were 'randomised'.

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail: Unclear who outcomes assessors were

Chantry 2010

MethodsSingle-centre RCT assessing videotape intervention to improve informed consent for neonatal circumcision, control group watched placebo video followed by traditional 1:1 informed consent discussion in both groups with physician about risks and benefits


Participants579 Mothers on a labour ward who were thinking about neonatal circumcision of whom 306 were randomised. 2 were excluded from analysis as trial group not recorded. 304 included in analysis. English speaking. Convenience sample

USA

Numbers of participants in analysis: 304

Intervention: 168

Control: 136


Interventions11-minute videotape giving explanation of risks and benefits as listed in the 1999 AAP Circumcision Policy Statement. Also included interviews with parents of older infants who had opted for and against newborn circumcision. Used still photographs depicting the procedure as part of this accompanied by narration. Produced for the trial, moderate quality. Watched through without navigation menu, approximately 1 to 2 hours after enrolment into trial

Placebo video was regarding breast feeding produced by the Supplemental Nutrition Program for Women, Infants and Children, watched at similar time

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesSatisfaction with consent process: verbal interview with 4 yes/no questions and a 5-point Likert scale. Gave composite mean satisfaction score where yes = 1, no = 0 for questions, and on Likert scale satisfied/very satisfied = 1 point (all other responses = 0). Not validated. Assessed after intervention, approximately 1 day. Secondary analysis of satisfaction was done 1 month post-discharge but not included since no data available

Short-term knowledge: assessed by 10-point composite knowledge score administered verbally (post-intervention, approx 1 day later, before discharge). Not validated. t-test analysis on composite score out of total 10

Perception of risk-provider bias - not used in this review


NotesAim: to determine if videotapes about newborn circumcision would be superior to traditional physician 'informed consent' discussion for maternal knowledge, satisfaction and perception of provider bias

Conclusion: videotaped information and an opportunity to ask questions was equivalent to provision of standard informed consent by a physician for maternal knowledge and satisfaction for the group of mothers in the study. Similar perception of provider bias for both groups


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomisation was achieved by ordering envelopes which contained a descriptor of the video to which the mother was assigned, chosen by roll of the dice

Allocation concealment (selection bias)High riskUneven group size resulted from inadvertent use of a series of 20 envelopes not previously randomised, this was picked up quickly indicating concealment concerns. Unclear whether used opaque envelopes

Incomplete outcome data (attrition bias)
All outcomes
High riskIn immediate knowledge scores each question is missing 1 or 2 answers (minimal). At follow-up, 43% control and 47% intervention lost to follow-up, so greater than 40% attrition

Selective reporting (reporting bias)High riskData collected in a telephone follow-up that was not reported. Asked 14 knowledge questions verbally but included results on 10

Other biasHigh riskConvenience sampling, high contamination rates (all on same labour ward), fidelity issues with 18 different clinicians used with differing training and skills

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskVerbally administered survey, outcome assessors not blinded

Cornoiu 2010a

MethodsSingle centre RCT comparing the use of multimedia presentations, pamphlets and standard verbal consent when consenting patients for knee arthroscopy surgery.

For the purposes of this review, the study has been split in two: Pamphlet versus Control and Interactive Multimedia versus Control. The N value for the control was divided by 2


Participants100 eligible participants undergoing knee arthroscopy, of whom 39 were excluded with the main reason being due to poor English skills. 61 patients were randomised with 22 participants in the Multimedia group, 21 in the pamphlet group and 18 in the control group.

Melbourne, Australia

Numbers of participants in analysis: 31

Intervention: 22

Control: 9


InterventionsThis study entry compares the standard verbal consent to the interactive multimedia group.

Prior to study a literature review of the published complications of knee arthroscopy was performed. Based on this review, consensus was reached between the authors for the average risk of each complication, to be presented in the pre-operative information.

A focus group of patients who had previously undergone knee arthroscopy was also undertaken to determine what information they would like to have been told prior to surgery. From this a list was derived that would form the core content for the verbal consent, the pamphlet and the multimedia intervention.

Standard Verbal Consent consisted of a verbal consent script developed using the core information derived from the literature review and focus group. This ensured that all patients received the same quality and amount of information.

The multimedia presentation consisted of an educational module including a mixture of voice, text, photographs and 3D computer animation, which was revised after piloting. The text included was identical to the verbal consent script, with the speech reflecting this and no extra information. The animation and audio tracks were integrated with appropriate text into an interactive linear program that allowed participants to progress and review information as desired.

Intervention development:designed for trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant from clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesImmediate, short-term and long-term knowledge: assessed 3 to 6 weeks prior to surgery, after receiving intervention, on the day of surgery and 6 weeks after surgery. Assessed using a 10-question knowledge quiz. In the paper only the data for immediate knowledge was presented in a numerically extractable form

Satisfaction with consent process: assessed using a 4 question survey with Likert scales relating to satisfaction with the amount, method and content of the information provided during the consent process. There were 5 possible responses to the questionnaire: Strongly agree (2 points), Agree (1 point), Undecided (0 points), Disagree (-1 point), Strongly disagree (-2 points). For the four questions the maximum response could be 8 and lowest –8

Anxiety: assessed 3 to 6 weeks prior to surgery, after receiving intervention, on the day of surgery and 6 weeks after surgery. assessed using an abbreviated mental state score and the Stait Trait Anxiety Index. For purposes of our review, assessment immediately after receiving intervention deemed to be "Anxiety with the consent process" and assessment on day of surgery deemed to be "general anxiety"


NotesAim: to compare the efficacy of a computer based multimedia presentation against standard verbal consent and information pamphlets for patients considering knee arthroscopy surgery

Conclusion: delivery of information using a combination of high quality computer animation, voice and text in this study appeared to provide improved patient understanding of surgery and complications. Higher satisfaction in the multimedia and verbal groups compared to those in the pamphlet arm. Anxiety levels were not significantly different between any groups

Author contacted: yes, contact was successful and original data were obtained for knowledge outcomes - original values and standard deviations obtained


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised by numbered ball allocation

Allocation concealment (selection bias)Low riskNot stated in paper, but author contact: "Randomisation was carried out by a numbered ball method placed in a box which the patient drew from. The number on the ball corresponded to the group which the patient would be allocated to (pamphlet, verbal or multimedia PC). There were only 3 balls and the patient was enrolled to the study prior to them choosing the ball. The research team did not have any direct influence on the allocation"

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskPotential risk of bias due to amount of information provided by treating surgeon at first consultation before entry into study. However, retrospective review revealed even spread of patients through all three consent groups with no correlation between surgeon and recall responses. Unlikely to have biased results

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo data in paper, author contact: the resident in the clinic administered the initial questionnaire. The preoperative questionnaire and post-operative questionnaire were administered by the research staff. They were not formally blinded to which group the patient belonged however the patient filled in the questionnaire without any direct intervention from the staff (except for being given instructions that all questions must be answered)

The main analyst was not blinded, however the statistician was.

Cornoiu 2010b

MethodsSingle centre RCT comparing the use of interactive multimedia presentations, pamphlets and standard verbal consent when consenting patients for knee arthroscopy surgery.

For the purposes of this review, the study has been split in two: Pamphlet versus Control and Interactive Multimedia versus Control. The N value for the control was divided by 2.


Participants100 eligible participants undergoing knee arthroscopy, of whom 39 were excluded with the main reason being due to poor English skills. 61 patients were randomised with 22 participants in the Multimedia group, 21 in the pamphlet group and 18 in the control group.

Melbourne, Australia

Numbers of participants in analysis: 30

Intervention: 21

Control: 9 (half of the control group)


InterventionsThis study entry compares the standard verbal consent to the pamphlet group.

Prior to study a literature review of the published complications of knee arthroscopy was performed. Based on this review, consensus was reached between the authors for the average risk of each complication, to be presented in the pre-operative information.

A focus group of patients who had previously undergone knee arthroscopy was also undertaken to determine what information they would like to have been told prior to surgery. From this a list was derived that would form the core content for the verbal consent, the pamphlet and the multimedia intervention.

Standard Verbal Consent consisted of a verbal consent script developed using the core information derived from the literature review and focus group. This ensured that all patients received the same quality and amount of information.

The pamphlet consisted of a single A4 page of 12 point Arial font with no pictures. Plain English at a grade 8 reading level was used, outlining the procedure and post-operative course, with most detail clarifying the possible risks and complications of the procedure.

Intervention development: designed for trial with reasonable effort for validation /piloting

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesImmediate, short-termand long-termknowledge: assessed 3 to 6 weeks prior to surgery, after receiving intervention, on the day of surgery and 6 weeks after surgery. Assessed using a 10 question knowledge quiz. In the paper only the data for immediate knowledge was presented in a numerically extractable form

Satisfaction with consent process: assessed using a 4 question survey with Likert scales relating to satisfaction with the amount, method and content of the information provided during the consent process. There were 5 possible responses to the questionnaire: Strongly agree (2 points), Agree (1 point), Undecided (0 points), Disagree (-1 point), Strongly Disagree (-2 points). For the four questions the maximum response could be 8 and lowest –8.

Anxiety: assessed 3 to 6 weeks prior to surgery, after receiving intervention, on the day of surgery and 6 weeks after surgery. assessed using an abbreviated mental state score and the Stait Trait Anxiety Index. For purposes of our review, assessment immediately after receiving intervention deemed to be "Anxiety with the consent process" and assessment on day of surgery deemed to be "General Anxiety"


NotesAim: to compare the efficacy of a computer-based multimedia presentation against standard verbal consent and information pamphlets for patients considering knee arthroscopy surgery

Conclusion: delivery of information using a combination of high quality computer animation, voice and text in this study appeared to provide improved patient understanding of surgery and complications. Higher satisfaction in the multimedia and verbal groups compared to those in the pamphlet arm. Anxiety levels were not significantly different between any groups

Author contacted: yes, contact was successful and original data were obtained for knowledge outcomes - original values and standard deviations obtained


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised by numbered ball allocation

Allocation concealment (selection bias)Low riskNot stated in paper, but author contact: "Randomisation was carried out by a numbered ball method placed in a box which the patient drew from. The number on the ball corresponded to the group which the patient would be allocated to (pamphlet, verbal or multimedia PC). There were only 3 balls and the patient was enrolled to the study prior to them choosing the ball. The research team did not have any direct influence on the allocation"

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskPotential risk of bias due to amount of information provided by treating surgeon at first consultation before entry into study. However, retrospective review revealed even spread of patients through all three consent groups with no correlation between surgeon and recall responses. Unlikely to have biased results

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo data in paper, author contact: The resident in the clinic administered the initial questionnaire. The preoperative questionnaire and post-operative questionnaire were administered by the research staff. They were not formally blinded to which group the patient belonged however the patient filled in the questionnaire without any direct intervention from the staff (except for being given instructions that all questions must be answered).

The main analyst was not blinded, however the statistician was.

Cowan 2007

MethodsRCT comparing a video intervention in either Spanish or English language as appropriate, versus routine discussion for intravenous contrast media with their Emergency Physician. Patients watched DVD at their bedside prior to CT scan in the Emergency Department


Participants202 enrolled participants of whom 49 were excluded and 41 refused participation. Total of 112 randomised, of which 107 completed the study. Intervention 53, control 54

USA

Numbers of participants in analysis: 107

Intervention: 53

Control: 54


InterventionsIV contrast media video developed by panel of 4 Emergency Physicians, based on expert opinion, pharmaceutical package inserts and current radiology literature. Videos were 5 minutes long, contained information on risks, benefits and alternatives of IVC. Language level was 8th grade level. Following watching DVD, patients were given the opportunity to speak to their Physician with any questions

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant from clinician

Intervention type: non-interactive audio-visual

Time of delivery: on admission


OutcomesImmediate knowledge: assessed by 10 question MCQ questionnaire - questions structured by the same physicians who made the video, and was administered immediately after the consultation

Satisfaction with the consent process: assessed by 4-point ordinal satisfaction scale. Excellent and good dichotomised to satisfied, poor and fair dichotomised to not satisfied. Satisfaction rated immediately after consultation

Rates of uptake: assessed by refusal to sign consent form


NotesAim: to determine whether Spanish & English educational videos are superior to routine discussion for informing emergency department patients about risks, benefits and alternatives to receiving IV contrast for CT

Conclusion: use of Spanish and English educational videos was superior to routine informed consent. Video assisted informed consent may also increase patient satisfaction with the informed consent process

Author contacted: yes, data available for risk of bias table and SDs for immediate knowledge scores


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskGenerated using a standard computer generated block randomisation routine available on-line at www.randomization.com

Allocation concealment (selection bias)Low riskGroup assignments placed in sealed opaque envelopes, sequentially opened after patients signed informed consent for the study

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll data accounted for, only 5 patients withdrew post-randomisation (clarified by author email)

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskSpecifically states not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskPilot of this study was blinded in this respect. Unable to assume study itself was also blinded

Danino 2006

MethodsPatients were given standard information on the surgical procedure and at a second consultation were randomised into the two groups during which they received a surgical consultation and examination. Both consultations were carried out by the surgeon. The intervention group then used the CD-ROM delivered by a psychologist


ParticipantsAll patients attending for aesthetic abdominoplasty between September 2002 and April 2004

France

Numbers of participants in analysis: 60

Intervention: 30

Control: 30


InterventionsCDROM with images explaining the procedure, risks and usual results.

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and used standardised leaflet

Done with clinician?: distant from clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesLong-term knowledge

Anxiety with consent process: STAI

General anxiety: STAI day of the operation

Economic: time taken to consent

No data reported in paper, only: “the consultation time between the patient and surgeon was not statistically significant between the two groups (+/- 3mm)”


NotesPublished in French, translated by Elinor Farrell and checked by Katy Wilkinson

Aim: the aim was to explore the effect of the introduction of images on CD-ROM on the knowledge and anxiety of the patient before abdominal plastic surgery

Conclusion: the introduction of images on CD-ROM has a beneficial effect on preoperative anxiety on patients undergoing abdominoplasty for aesthetic reasons


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail. States that they were randomly assigned, no further detail

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Deyo 2000

MethodsMulticentre RCT, comparing video disc and written booklet versus booklet alone


Participants393 elective candidates for lower back surgery were randomised. Patients were identified from referrals to neurosurgery and primary care clinics. Patients from Iowa were selected by study surgeons if they believed that lumbar surgery was a treatment option and if they had received non surgical therapy for greater than 4 weeks. Participants were comparable at baselines, age, gender, ethnicity, education level, married/living as married, employment and smoker/non-smoker demographics measured

Seattle, USA

Numbers of participants in analysis: 343

Intervention: 171

Control: 172


InterventionsVideo disc plus written booklet versus written booklet alone. Patients in the intervention groups used an interactive programme on a videodisk player, modified micro-computer, monitor with touch screen and printer. They entered their ages and diagnoses (herniated disc, spinal stenosis or non-specific back pain) into the session and then viewed material specific to their condition. The video programme included animated graphics of spinal anatomy, discussion of causes of back pain, ambiguities in diagnosis, interviews with patients including good and bad outcomes. Subjects were able to control the order of the presentation, repeat segments and obtain further information on other topics. They then were given a printed copy of outcome probabilities and the surgeon was informed of segments watched

Control group received a written booklet containing illustrations of the lumbar spine, discussion of surgical and non-surgical treatments for herniated disks and spinal stenosis, general description of expected outcome and a short self test

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal with special leaflet

Done with clinician?: distant from clinician

Intervention type: interactive audio-visual

Time of delivery: before admission


OutcomesSatisfaction with decision making: information taken from satisfaction with decision making process, table 3. Five questions were taken to include satisfaction with consent therefore the median effect size was taken as per protocol

Locus of control: information was taken from table 3. Three questions were felt to reflect locus of control, therefore the question with the median effect size was selected as per protocol

Pain: both back and leg pain results were combined as these were both felt to be clinically important. An average pain answer was calculated from given percentages, and used to work out the N of people who would have pain for this hypothetical average question

Rate of uptake of surgery: telephoned patients at 3 months and 1 year

Economic resource use: information was only available for one of the study sites (Group Health Coop-Seattle)stated that there were no significant differences in the number of physician visits or physical therapy visits for low back pain, spine imaging studies, pharmacy or laboratory use between the two groups. The only significant difference in utilization was for outpatient back surgery amongst patients with herniated discs; the proportions of subjects undergoing surgery was significantly lower in the video group


NotesAim: to determine the impact of shared decision making on patient satisfaction outcomes and choices of surgical or non-surgical treatment

Conclusion: the programme appears to facilitate decision making and may help ensure informed consent. For patients with herniated discs it reduced the surgery rate without diminishing patient outcomes. its impact on cost of care depends on the proportion of patients with various diagnoses and on local surgery rates

Author contacted: yes, no further data available


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated randomisation

Allocation concealment (selection bias)Low riskNumbered opaque envelopes

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskSurgeons in the trial had already viewed both sources of information. Possible contamination. Utlisation of services data used to check service use, however comprehensive utilisation data were unavailable for one of the study sites

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Elfant 1995

MethodsRCT- single centre, looking at the effect of time on recall of elements of informed consent


Participants60 patients scheduled to undergo elective colonoscopy or endoscopy. Unclear if groups were comparable at baseline although age and gender were recorded

New Jersey, USA

Numbers of participants in analysis: 60

Intervention: 30

Control: 30


InterventionsTime-standard care was informed consent on the day of the procedure, intervention was informed consent 24 to 72 hours prior to the procedure. One clinical investigator consented both groups, no standardised sheet was used. The same content was used, timing of the consent information was the only difference between the groups

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: face-to-face

Intervention type: alteration of timing

Time of delivery: before (intervention group) and on admission (control group)


OutcomesShort-term knowledge: total recall of consent information over the telephone-short term (1 to 3 days after the procedure)


NotesAim: to determine if recall of informed consent is affected by the timing of obtaining informed consent before endoscopic procedures

Conclusion: despite similar rates of recall at follow-up, we recommend pre-procedure discussion and obtaining informed consent a few days before the procedure whenever possible


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskPatients were randomly assigned to one of two groups. No other information given

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskUsed one investigator, no standardised script used

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail. Post-op telephone recall was done by another investigator who may have been blinded but no information was given

Enzenhofer 2004

MethodsPatients admitted to the ward had a conversation with the physician, +/- intervention and then filled out a questionnaire on satisfaction and knowledge.


Participants56 patients undergoing either cardiology procedures or endoscopy procedures. 28 in control and intervention. For patient satisfaction 3 patients were lost to follow up in the intervention group and none in the control. For the patient knowledge test 4 patients were lost to follow up in the intervention group and 3 in the control group

Germany

Numbers of participants in analysis: 49

Intervention: 24

Control: 25


InterventionsA 5 minute computer based visualisation programme. Containing conversation between a physician and a patient, pictures which patients could point on and receive a short explanation. Patients were also given a information brochure to both the intervention and control groups

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: interactive audio-visual

Time of delivery: on admission


OutcomesSatisfaction with the consent process: asked shortly after intervention, 5 questions with a five point ranking scale used, max score was 25 which indicates good satisfaction. Average scores were reported

Short-term knowledge: within 3 days of the intervention, 10 questions asked right or wrong scoring, score out of 10, 10 = good knowledge, average scores re-reported, recorded as Intermediate recall

Economic-time for consultation: was recorded by the physician, average time for consultation was reported


NotesAim: does using computer based visualisation of a procedure improve patient satisfaction with the consent process and knowledge of the procedure

Conclusion: computer based intervention improves patient satisfaction and knowledge


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskShuffled envelopes, doctors unaware of frequency of allocation within their envelopes

Allocation concealment (selection bias)Unclear riskInsufficient detail. No details on whether the envelopes were opaque

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskIndependent supervisors were blinded and they collected the questionnaires. Statisticians were blinded

Felley 2008

Methods2-centre RCT comparing the combination of written and oral or oral information alone before endoscopy on the patient's assessment of quality of information and level of anxiety


Participants912 randomised patients of whom 577 were included in final analysis. Patients in 2 hospitals undergoing elective upper or lower GI endoscopy. Enrolled over a 3-month period

Switzerland

Numbers of participants in analysis: 577

Intervention: 278

Control: 299


InterventionsWritten information booklet all the standard information regularly given to patients and detailing risks and benefits of procedure, treatment of complications and possibility of receiving hypnotic drug during the procedure (with related risks). This was posted to randomised intervention participants along with appointment details approximately 1 week before procedure and before informed consent for the study discussed

Intervention development: no details

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent

Done with clinician?: distant from clinician

Intervention type: written

Time of delivery: before for intervention


OutcomesSatisfaction with consent process: assessed with mean score of 8-questions posted back day after endoscopy

General anxiety: post-event, posted back. Rating scale none-strong - dichotomous outcome

Rates of uptake: (or refusal) of clinical procedures (numbers cancelling procedure out of original 912 patients) - given cancellation rates but converted to uptake rates for comparison with other studies

Pain: during procedure (rating scale none-strong) - dichotomous outcome

All outcomes assessed by questionnaire that was taken home and posted back after endoscopy


NotesAim: to assess the effects of combined written and oral information compared to oral information alone on the quality of information before endoscopy and level of anxiety

Conclusion: study found that structured and comprehensive written information is perceived as beneficial by patients, without a negative impact on anxiety.

There was also a statistically significant increase in cancellation rates in the intervention group over the control. This was not followed up and its unclear whether there were any adverse events from the cancellations


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
High risk46% attrition

Selective reporting (reporting bias)Low riskHas trial protocol ISRCTN 34382782. Details all outcomes included

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; no information on whether questionnaires were anonymised

Fink 2010

MethodsMulticentre RCT at 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VA’s computer based platform. iMedConsent is a computer generated informed consent document with the patient when reviewing the indications, risks, benefits and alternatives specific to the operation. Comprehension and satisfaction was measured directly after completion of informed consent discussion


Participants502 patients scheduled for 1 of 4 elective surgical procedures (carotid endarterectomy, laparoscopic cholecystectomy, radical prostatectomy and total hip arthroplasty) scheduled between August 2006 and June 2008. Patients were comparable at baseline, measured on age, gender, ethnicity, marital status, education, reading ability, employment, health status and health literacy

USA

Numbers of participants in analysis: 539

Intervention: 263

Control: 276


InterventionsPatient proceeded with the informed consent process as in the standard iMedConsent process however, when the provider and the patient were ready to sign the consent a RB dialogue was initiated. RB dialogue consisted of the subject being able to describe the diagnosis, procedure, anatomic location, risks, benefits and alternatives to the proposed procedure

Patients in the control group received standard consent using the iMedConsent process where consent is sort by following the computer-generated informed consent document with the patient when reviewing the indications, risks, benefits and alternatives

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: audio-visual

Done with clinician?: face-to-face

Intervention type: structured consent

Time of delivery: before admission


OutcomesImmediate knowledge: after consent discussion-used customized VHA questionnaire

Satisfaction with decision making: independent questionnaire for this study found at http://links.lww.com/SLA/A52. Measured satisfaction with decision making as a sub scale with 6 questions each on a 1 to 5 scale, therefore out of total 30 points

Anxiety with the consent process: STAI

Economic-time taken to consent: iMedConsent programme was reconfigured with internal time stamps which recorded the length of consultation time

Time was reported using median, mean and SD. Authors used Ilcoxon test indicating that results were not evenly distributed. Therefore contact with author was established and the IQR obtained. Non-parametric data

Comprehension and satisfaction were measured directly after completion of the informed consent process. Patient anxiety was measured before and after the consent discussion. Provider attitudes were measured at the end of study enrolment/after the residents surgical rotation was finished


NotesAim: use of repeat back will: 1) improve the surgical patient's comprehension, 2) lead to better patient satisfaction with the consent process and the healthcare received, 3) lessen patient anxiety about the surgical procedure, 3) lessen patient anxiety about the surgical procedure, 4) be acceptable to surgical providers

Conclusion: repeat back implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. Repeat back should be considered as an enhancement to surgical informed consent

Author contacted: yes, data available for outcome 'time taken to consent'


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised using an internet based programme which used a concealed, computer-generated simple randomisation scheme without stratification

Allocation concealment (selection bias)Low riskThe randomisation sequence was concealed from each centre's personnel

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Low riskClinical trial was registered (NCT 00288899), outcomes reported

Other biasHigh riskConcern with contamination as some providers were assigned to both groups. No information about controlling information between the two groups

There were small differences in baseline characteristics between the 2 groups, with a higher percentage of males and 'white' ethnic origin in the RB group

The RB group were also older, likely to be retired and had a better SF12 mental score and less anxiety at study entry (P < 0.05)

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskTrial was not blinded

Friedlander 2011

MethodsSingle-centre RCT looking at improving parental informed consent for paediatric upper GI endoscopy with an interactive on-line video module the night before endoscopy versus usual care consent consultations


Participants220 consecutive parents of patients were eligible; 190 were randomised and then 42 withdrew leaving a total of 148 (74 in each group). Intention to treat analysis not performed. Included patients from a pilot study due to under-powered numbers in secondary analysis after drop-out

Comparable at baseline, similar education levels, 60 to 70% Caucasian.

USA

Numbers of participants in analysis: 97

Intervention: 47

Control: 50


InterventionsIntervention group: Interactive internet-based video module covering the information required to be delivered by a physician obtaining informed consent. 6th-grade reading level. Commercially available. Viewed from home the night before endoscopy, took a minimum of 20 minutes to complete, families able to pause and repeat sections as needed. Tracked via a monitored website, total time spent on the video recorded but not presented in paper

Control group: also used internet the night before endoscopy but only to fill out baseline questionnaires. On day of endoscopy, both groups received same treatment (form-based consent consultation with clinician)

Intervention development: standard information with no modifications

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesInformed consent: this was measured on a questionnaire published by Woodrow et al. 2006 with some modifications (modified Consent-20 form). Not validated in current form and no reliability testing. Maximum score of 40 possible, some free-text answers included, 2 points scored for correct answer versus 0 for incorrect answer. Completed immediately after informed consent consultation

Anxiety with consent process: state scale of STAI, measured at baseline the night before endoscopy and immediately after informed consent consultation.

Satisfaction: measure this with questions that assess the whole hospital stay rather than the consent process or decision-making, therefore not included as an outcome in this study

Desire for further information: number of questions that parents in each group wanted to ask were written by the parents the night before endoscopy and counted when attending for the procedure. This information is not available in a form that could be used in the meta-analyses. We have medians and ranges for each group (intervention median 1 question, range 0 to 14, n = 60; control median 3 questions, range 0 to 9, n = 63; P = 0.0053 with Mann-Whitney test)


NotesAim: to evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy

Conclusion: this study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or satisfaction. Additional study of informed consent is required


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskRandomisation by alternating numbers

Allocation concealment (selection bias)High riskAlternating numbers therefore high risk of predicting next participant's allocation

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition rates for primary analysis 51/148 = 34% (i.e. < 40%). Used pilot data to increase numbers for secondary analysis as a post-hoc strategy

Selective reporting (reporting bias)High riskRegistered trial at http://clinicaltrials.gov with identifier NCT00899392. State that they are looking at flow through the endoscopy suite but do not report this in the paper

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskClinicians blinded but participants gave informed consent for the study and were not. Outcomes included subjective measure e.g. anxiety, so possibility of Hawthorne effect after consent given

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll questions were read and answered in private. Answers were entered by the subject on a laptop computer and recorded electronically into a secure database

Garden 1996

Methods3 armed RCT, assessing outcomes at base line and after delivery of intervention on the day before cardiac surgery. One arm excluded as they were given less information


ParticipantsPre-op patients waiting for cardiac surgery (consent for the anaesthetic for the cardiac surgery). 57 eligible patients of whom 9 declined and 3 were excluded and 1 withdrew due to anxiety. The remaining 44 were randomised into 3 groups. 2 groups of interest to our study consisted of 15 participants of whom all were included in analysis

New Zealand

Numbers of participants in analysis: 30

Intervention: 15

Control: 15


InterventionsInformation booklet with different amount of details. The routine care group had a booklet with details of anaesthetic risks already widely used in New Zealand and enforced by the New Zealand Society of Anaesthetists content is based on what a reasonable doctor thought a patients needs to be told. The detailed booklet gave even more detailed information about anaesthetics and the risks involved

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesAnxiety with consent process: STAI measured after intervention

Immediate knowledge: score out of 10, difference between scores measured at baseline and then after the intervention (both before surgery)


NotesAim: to evaluate anxiety and knowledge using different information disclosure levels in patient information booklets

Conclusion: anxiety not affected by level of information disclosed but knowledge and recall of facts did improve with full information

Author contacted: yes, data available for risk of bias table


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomised" no further details. Response from author – a table of random numbers was used to undertake block randomisation

Allocation concealment (selection bias)Low riskResponse from author – no chance that the intervention allocation could have been foreseen in advance or during patient enrolment

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%. Full breakdown given, loss to follow up due to deaths and strokes. 32% attrition

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Low riskInsufficient detail in report

Response from authors: the patients were blinded to the group allocation. They received leaflets that were numbered 1-n, and had been prearranged in that order that reflected the randomisation.  The leaflets were handed out by a senior registrar and that was his sole role.  He didn't participate in the randomisation or the analysis

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskAll data collection questionnaires delivered by study investigator

Response from author: the assessment was a questionnaire. All participants filled out the same questionnaire

Insufficient detail to assess if personnel analysing the questionnaire were blinded or if questionnaire anonymised

Garrud 2001

MethodsRCT in Nottingham UK, comparing detailed leaflet to standard leaflet in patients undergoing elective gynaecological laparoscopy. Assessed using knowledge, satisfaction and anxiety via telephone interview 2 to 3 days after the intervention was delivered


Participants41 female patients undergoing gynaecological laparoscopy, of whom all completed the study

United Kingdom

Numbers of participants in analysis: 41

Intervention: 20

Control: 21


InterventionsRevised detailed leaflet including more information on the risks of laparoscopy - bullet pointing text and lower reading age (16 years)

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesShort-term knowledge: assessed via telephone interview, 2 to 3 days following appointment. 5 open ended questions about what a laparoscopy is, why it is carried out, what the risks and complications are, where you can get further information, what happens afterwards and what pain or discomfort may be experienced. Scored for presence of different factual elements, to a maximum score of 23

Satisfaction with consent process: telephone survey, 2 to 3 days following appointment using a modification of medical interview satisfaction scale cognitive sub-scale, where referent for each of the nine items was changed from “the doctor” to “the leaflet” Possible scores range from minimum of 9 - maximum of 45, with higher scores being more satisfied

Anxiety with consent process: telephone survey using 6 item version of Spielberger State-Trait Anxiety Inventory. Possible scores ranged from 6 to 24, with higher scores representing greater anxiety


NotesAim: to compare detailed risk leaflet to a standard one in terms of knowledge, satisfaction and anxiety.

Conclusion: detailed leaflet resulted in higher knowledge and satisfaction without increasing anxiety.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskBlock randomisation based on the week they attended clinic

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Low riskTwo leaflets and patients unaware of what the other contained

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Gerancher 2000

MethodsRCT-Women admitted in labour to delivery suite but before the initiation of labour analgesia or administration of parenteral medications. Interview with anaesthetist lasted 10 mins for both control and intervention groups


Participants113 labouring women, considering epidural or GA as part of labour

USA

Numbers of participants in analysis: 82

Intervention: 44

Control: 38


InterventionsInterview between the patient and the anaesthetist with a review of the patient's medical condition and presentation of anaesthetic options. Investigator used a 10 point checklist and if in intervention group, patient and doctor reviewed and then signed a consent document

Intervention development: no details

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesLong-term knowledge: phone survey 5 to 7 months after delivery, a score was given out of 100, 10 questions asked, 10 point for correct answer, 0 for incorrect and 5 for I don't know, median scores and IQR reported


NotesAim: to determine the ability of a woman in labour to recall preanaesthesia discussion with her anaesthesiologist and to determine if written consent added to this discussion improves recall

Conclusion: regardless of the provision of a written document being used as part of the consent process, women in labour were able to recall the risks of epidural labour analgesia and the process of consent with a high degree of reliability.the practice of adding written to verbal consent during labour analgesia may increase recall of medical info slightly

Author contacted: yes, no further data available to check excluded numbers and complete risk of bias table


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail. Random assignment - no further description

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40% (27%)

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcomes measured by blinded research assistant who read out questions over the telephone

Goel 2001

MethodsMulti-centre RCT looking at the effect of a decision aid for the surgical treatment in early breast cancer. Randomisation was of surgeons rather than patients since intervention directed at surgeon-patient interaction. Consent for the study was obtained from patients the surgeons saw, then the patients given baseline questionnaires before accessing intervention/control pamphlet. A second (post-intervention) patient questionnaire was completed at home with telephone prompting 48 to 72 hours later to check completed. Looked at satisfaction with decision making, anxiety with decision making and short-term knowledge recall. A further questionnaire was mailed at 6 months. No raw data for 6 months' results


Participants232 surgeons were eligible, and 69 were randomised after showing some interest. Study nurses visited surgeons after randomisation with more information, and 57 surgeons were used for study results; 29 recruiting patients into the control group and a separate 28 recruiting patients into the intervention group.

164 patients with newly-diagnosed stage I or II breast cancer with no prior history of cancer and who were suitable to have either mastectomy or breast conservation therapy were recruited, who could consent and complete the study questionnaires. No difference in baseline demographics - looked at education, employment and language. In total, 136 patients were included in analysis; 50 in the control group and 86 in the intervention group

Canada

Numbers of participants in analysis: 123

Intervention: 78

Control: 45


InterventionsDevelopment: the decision aid was developed previously (Sawka et al. 1998. Development of a patient decision aid for choice of surgical treatment for breast cancer. Health Expect 1:22-36). High quality intervention - development included literature review, focus groups of women with breast cancer, consultation with experts and sequential pilot studies. Information was updated where required in line with current evidence.

Content: grade 8 reading-level. Contains a 3-step process of 1) women asked to review advantages/disadvantages of each procedure, 2) consideration of value of each of the advantages/disadvantages, 3) examination of worksheet to identify which procedure she is leaning towards.

Format: audiotape and workbook to be used in the consultation and at home. Booklet uses colour photographs and describes the likelihood of events in graphical form using 100 figures to provide quantitative information. Tape supplements workbook.

Setting: given to take home after initial decision on type of surgery made with the surgeon

Control group: had similar consultation with the surgeon and given all the same information to take home, but in a non-interactive form. This was in the form of a tri-fold pamphlet with no numbers, photographs, graphics or values - clarification exercise

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: brief training

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and special leaflet

Done with clinician?: face-to-face

Intervention type: multiple including decision aid

Time of delivery: before admission


OutcomesSatisfaction with decision making: measured on the Decisional Conflict Scale (we are using the perceived effectiveness sub-scale to estimate satisfaction, in line with other similar study data). Validated and reliable tool. Questionnaire completed within 72 hours of consultation with surgeon and choice of treatment, then mailed back to study organisers. Score converted from total 5 to total 100 in keeping with reporting convention from other systematic reviews

Anxiety with decision process: measured on STAI scale. Done after initial consultation with choice of treatment, then again within 72 hours after consultation. Also completed at 6 months'. No raw data for this outcome - "There were no differences in anxiety across the 2 study groups. Both groups showed high levels of anxiety at enrolment and preoperatively, above 50 points. At the 6 month follow-up, these dropped equally to about 35 points,within the normal population range"

Short-term knowledge: measured on BCIT-R scores (Breast Cancer Information Test-Revised), a validated and reliable tool. Consists of 18 true/false questions (Ward and Griffin, 1990. Developing a test of knowledge of surgical options for breast cancer. Cancer Nurse 13:191-6).Completed the questionnaire at home and mailed back approximately 72 hours after consultation where made treatment choice and intervention/control pamphlet were given

Decisional Conflict: measured on the Decisional Conflict Scale using total score for all sub-scales. Validated and reliable tool


NotesAim: to evaluate the effect of a decision aid for the surgical treatment in early breast cancer

Conclusion: "Although the decision aid had minimal impact on the main study outcomes, a subgroup may have benefited. Such subgroups should be identified, and appropriate decision support interventions should be developed and evaluated"


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSurgeons were randomised prior to the nurse visit to either the decision aid or pamphlet intervention in blocks of 8 based on a random number generator

Allocation concealment (selection bias)Unclear riskInsufficient detail. The allocation was not revealed to the surgeon until after agreement to participate in the study was obtained, but unclear how this was done

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition rate of participating surgeons of 18% from those who engaged in study after recruitment (57/69)

Attrition rate of participating patients 7% for pre-op follow-up (mailing the questionnaire back after 72 hours to complete it from initial consultation) and 20% for follow-up at 6-months

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Greening 1999

MethodsRCT, inpatients approached and structured interviews given before ECT, outcomes measured before ECT and 1 to 7 days following completion of ECT (number of treatment medians 9 range 4 to 19)


ParticipantsInformal patients with depression in a psychiatric hospital awaiting ECT

Birmingham, United Kingdom

Numbers of participants in analysis: 28

Originally the groups were 16 in control and intervention. 3 were lost to follow-up. We have assumed 14 per group at follow-up. Unable to gain correct details from author

Intervention: 14

Control: 14


InterventionsStructured consent process/interview, 10 basic points were covered and short specific verbal and written statements were given simultaneously with pictures. Subjects were asked to recall these points and the process was repeated three times or until all ten items were remembered

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: all delivered by key researcher

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and standardised leaflet

Done with clinician?: face-to-face

Intervention type: structured consent

Time of delivery: on admission


OutcomesShort-term and long-term knowledge: questionnaire marked out of 20 measured before ECT. Total number measured was 29, details of N values for each group not available (continuous data)

Recall measured after ECT finished - this varied from one course to 9 months (long-term knowledge - non-parametric data)


NotesAim: to see if structured consent improved knowledge of ECT

Conclusion: knowledge on ECT was improved with the structured interview warranting further study (this was a pilot - no further study has been done to date by these authors)

Author contacted: yes, no further data accessible


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Sealed envelope technique" - not stated how random sequence generated

Allocation concealment (selection bias)Unclear riskInsufficient detail; sealed envelopes, unclear if opaque

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%. Small loss to follow up for pre-ECT data, details of drop-outs given, 2 withdrew consent one absconded, one had treatment terminated due to PE

Selective reporting (reporting bias)Low riskProtocol pilot study, outcomes all reported

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants not blinded and intervention delivered by trial investigator/author

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome rated by blinded investigator

Heller 2008

MethodsProspective RCT, evaluating the impact of an interactive digital education aid on knowledge and satisfaction in patients undergoing breast reconstruction for breast cancer. Assessed at clinic visit before receiving information, immediately before surgery after having received intervention and one month after surgery


Participants274 breast cancer patients undergoing breast reconstruction were randomised, of whom 133 completed the study, 66 in the intervention group, 67 in the control group.

Texas, USA

Numbers of participants in analysis: 133

Intervention: 66

Control: 67


InterventionsThe interactive digital education aid is a menu driven, interactive software program that includes high-quality, three-dimensional animated graphics, patient testimonials, before-and-after photographs, and video explanations from plastic surgeons and clinical specialists in surgical, medical, and radiation oncology. It required 3 years to produce

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: interactive audio-visual

Time of delivery: before admission


OutcomesShort-term knowledge: assessed using 12 answer questionnaire, completed at three time points: 1) Before intervention, 2) Immediately before surgery after having received information and 3) 1 month after surgery. Data presented in paper was "mean change between time 1 and time 2"

Satisfaction with consent process: assessed using a 1 to 5 Likert scale. Data presented in paper is dichotomous. Clarification from author sought who was unable to recall how dichotomised. Entered data as dichotomous data from  Table 5 in paper

Generalised anxiety: assessed using Spielberger State Trait Anxiety Index at 3 time-points listed above. Data presented in graphical format in paper (Fig. 3). No extractable data in paper. Authors contacted but no longer has access to the data. Agreed with statistician that unable to include this outcome in our review

Desire for further information: participants asked "Did you receive all the necessary information?" Data presented as dichotomous, "Yes/No." For purpose of this review, No = desire for further information present


NotesAim: to assess the effectiveness of an interactive digital education aid

Conclusion: this study found that an interactive digital education aid that explains the various methods of breast reconstruction can contribute significantly to the patient’s education. Having the opportunity to obtain information from both the interactive educational aid and the medical team appeared to be beneficial, particularly in terms of increasing the patient’s knowledge about the procedures themselves and increasing the patient’s satisfaction with how the information was delivered

Author contact: yes, for raw data for outcomes 'short-term knowledge', 'satisfaction with consent process' and 'generalised anxiety'. No further data available from the authors.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated randomisation

Allocation concealment (selection bias)Unclear riskInsufficient detail; author response insufficient to make judgement

Incomplete outcome data (attrition bias)
All outcomes
High riskOf initial randomised patients, 51% dropped out once randomised to leaflet (n = 73) or because did not complete all questionnaires (n = 68)

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded; large dropout rate when found were not in intervention group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNo form of outcome assessment blinding

Henry 2008

MethodsRCT comparing a leaflet with pictures of common otological surgery risks with a leaflet (usual care) without pictures in one tertiary-referral centre


Participants51 consecutive patients on the list for 4 otologic procedures under 2 consultants conducted over a 14 month period. 51 completed initial outcome measures, but then sub-sample of 31 looked at (with 26 responding) for secondary outcomes at 1 year

Canada

Numbers of participants in analysis: 51

Intervention: 23

Control: 28


InterventionsLeaflet detailing common surgical risks with pictures versus non-pictorial usual care standard leaflet. Handed out after informed consent consultation for the procedure to take home. Rated by BM and KP as poor quality - pictures differ in style and clarity, no background preparation described and no previous validation. List of complications included facial nerve injury, worsened hearing, vertigo, operation failure, wound infection, tympanic membrane perforation, alteration in taste and complete sensorineural hearing loss

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal with standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesLong-term knowledge: recall of as many complications as possible via a telephone communication with a separate investigator a mean duration of 19 days (range 14 to 49 days) after the intervention given out (+consent given). Standardised questions, no prompting or suggestion

Measured as percentage of those risks discussed with the surgeon


NotesAim: to test whether pictures in a handout improved patients' recall of otological surgical risks

Conclusion: pictorial cues do not improve patients' recall of surgical risks but education level does

Author contacted: yes, no further data accessible


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPerformed using a computer-generated binomial randomisation list

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up at initial outcome measures. Although only 26 (50%) followed-up at one year we have not used this data for the outcomes of interest in this review

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskContamination risks - not addressed in study design

Secondly, post-hoc alteration in study design to collect more data on last 31 participants - unanonymised data on these to enable follow-up, of which 26 replied when contacted

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; outcome assessed by a separate investigator but unclear whether aware of allocations

Hermann 2002

MethodsSingle-centre RCT evaluating the effects of using a non-interactive animated video lasting 7 minutes on knowledge prior to elective thyroidectomy


Participants80 participants (22.5% male) were randomised to intervention (n = 36) or control (n = 44). All were undergoing elective thyroidectomy. No other demographic baseline details were given. Inclusion criteria included those undergoing thyroidectomy, there were no exclusion criteria given

Vienna, Austria

Numbers of participants in analysis: 80

Intervention: 36

Control: 44


InterventionsIntervention: participants in this arm were first asked to watch a 7 minute video detailing the steps of thyroidectomy surgery, then the outcome assessments were made. Participants in this arm then had an informed consent discussion with clinicians

Video: designed by the researchers for the trial, no formal assessment of quality made. 7 minutes in total, used 3D models (although appears in study that presented to patients in 2D only). Setting was in hospital on the morning of scheduled operation

Control: participants in this arm were given written information similar in content to the information included in the video, and more detailed than information usually used in standard care. They had 10 minutes to read this, and then the outcome assessments were done. Participants then got a chance to watch the video before participating in an informed consent discussion with clinicians. Note: all outcome data were collected before they watched the video, so do qualify as a control group

Intervention development: designed for the trial with no validation

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: on admission


OutcomesPatient' self-report of understanding: measured with 2 written questions measured on 1 to 5 point Likert scales with high scores = better knowledge. These were not validated previously. The questions were:

Qu1: 'After this explanation, can you image what happens during the operation?'

Qu2: 'Have you understood the steps in the operation?'

We have taken Qu2 as relevant to this review and used the data from this question in our outcome analysis (continuous data)

Immediate knowledge: measured with 2 free-text written questions:

Qu1: 'Describe the important steps of the operation in your own words?'

Qu2: 'Which risks are part of this operation?'

We have taken Qu2 to represent knowledge required for informed consent (continuous data)

Fear, "inner yes" and perceived competency of doctor and the service outcomes not included in this review


NotesAim: to analyse the merits of computerized animation to illustrate a difficult treatment process i.e. the progressive steps of a thyroid operation, in comparison to the use of conventional flyers

Conclusion: “Preoperative surgical information can be optimised by presenting the operative procedure via computer animation. Nowadays, several types of new media such as the Internet, CD, DVD and digital TV are readily available and –as shown here – suitable for effective visual explanation. Most patients are familiar with acquiring new information by one of these means. An appropriately designed 3D representation is met with a high level of acceptance, as the present study clearly shows. Modern patient-based information systems are necessary. They can no longer be the sole responsibility of the medical profession, but must be on the agenda of hospital managements and of medical care systems as well.”


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up. Analysed with intention-to-treat

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

No information on researchers being blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskAdditional questions were included on control questionnaire, therefore easy to guess grouping. Researchers scored free-text objective questions and converted them to a 1 to 5 point scale so potential for detection bias

Hong 2009

MethodsMulticentre-RCT assessing the effectiveness of written information versus. traditional oral dialogue, in rhinoplasty. No information was given in the paper on when the pamphlet was given to the intervention group


Participants100 consecutive patients for rhinoplasty, multi centre trial. None of the patients were aware that they were in a study until they were phoned two weeks later after surgery and when authors completed knowledge questionnaire

Canada

Numbers of participants in analysis: 100

Intervention: 48

Control: 52


InterventionsBoth groups received a standard initial consultation including a detailed discussion of the potential risks and complication of the operation. Prior to the commencement of the study, a list of the most common and significant risks of rhinoplasty was generated. The participating surgeons used a set form during the consultation, which included a checklist of the 5 potential complications, to strive for a consistent discussion with the patients. In addition the intervention group received a written pamphlet outlining the risks of rhinoplasty

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesLong-term knowledge: 14 to 18 days after initial consultation


NotesAim: to determine the effectiveness of providing written information in enhancing patient understanding and retention

Conclusion: risk recall in rhinoplasty is improved with the addition of written information during the informed consent process. More specifically female patients and those with a higher level of education seemed to benefit from receiving supplementary information


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated roll of die then allocated according to odd/even numbers

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were unaware of being in a trial, however were then informed when the outcome was measured 14 to 18 days later. Impossible to blind participants as received different interventions

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot blinded. Telephone interviewers were aware of allocation

Hopper 1994

MethodsRCT patients either receive standard written consent form or use video information program. Knowledge assessed by questionnaire after consent, prior to scan. Satisfaction with consent process measured at same time. Time taken was timed during the process


Participants160 consecutive patients, referred for imaging examination (venography, excretory urography and CT requiring IV contrast) during week day hours

Pennsylvania USA

Numbers of participants in analysis: 160

Intervention: 80

Control: 80


InterventionsInteractive video providing information on risks of IV contrast material. Patients were able to select as much or as little information as they chose

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: interactive audio-visual

Time of delivery: on admission


OutcomesImmediate knowledge: MCQ - 7 questions relating to knowledge

Satisfaction with the consent process: 5-point scale 1 = much more than satisfied, 5 = much less than satisfied (scores inverted when entered into RevMan)

Economic - length of consultation: time reported in minutes

Standard deviations for all outcome measurements calculated using usablestats.com


NotesAim: to evaluate interactive computer-based informed consent (interactive video) for use of contrast material versus the same information in a written format

Conclusion: the video informed consent for use of IVCM is a possible alternative to the written consent form


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomised into one of 8 groups, then computer generated randomisation to then allocate to intervention or control

Allocation concealment (selection bias)Unclear riskInsufficient details

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient details

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient details

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient details

Johnson 2006

MethodsSingle-centre RCT using normal consent process versus consent process with aid of a face:face decision aid to clarify treatment options, benefits, risks, prognosis and costs when root canal therapy or extraction of a tooth is indicated


Participants80 eligible participants were approached and 70 recruited. 3 were lost to follow-up and analysis was based on the 67 that completed outcome questionnaires. All were consecutive patients in a postgraduate endodontics clinic who had been through preliminary dental screening and whom had all been considered eligible for root canal treatment

Chicago, USA

Numbers of participants in analysis: 67

Intervention: 32

Control: 35


Interventions4 second-year endodontic residents underwent training with a pilot of 40 patients, learning how to present information with the decision board. The principal investigator oversaw delivery discretely to ensure consistent use of the decision aid

The decision aid was a face:face paper aid on one page addressing 5 treatment options and including information for each option on; time required/appointment numbers necessary, costs, risks of treatment and infection, chance of keeping the tooth/replacement for 5 years or more, a diagram to illustrate each option. The decision aid was developed at the University of Illinois with involvement from experienced staff and dental experts, using evidence-based data.

The control group had 'usual care' informed consent process

? delivered in clinic on day that treatment was initiated - emailed authors to check but no response. Consensus of 2 review authors that occurred on day treatment initiated

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: structured/extensive training

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: face-to-face

Intervention type: decision aid

Time of delivery: on admission


OutcomesImmediate knowledge: measured on 5 questions (no validity or reliability testing). Given a point for each correct answer. Results presented as mean score/5 and SD for each trial arm

Satisfaction with consent process: measured with one question (no validity or reliability testing). "How satisfied were you with the explanation of your treatment options?". 7-point Likert scale indicating satisfaction. Reported as number per group giving each possible answer on Likert scale. For this Review, taken all 'satisfied' options (somewhat satisfied/satisfied/very satisfied) and used as dichotomous data - those satisfied per trial arm

General anxiety: measured with one question (no validity or reliability testing). "Did the explanation of treatment options make you more or less anxious about the treatment?". 7-point Likert scale indicating anxiety. Reported as number per group giving each possible answer on Likert scale. For this Review, taken all 'anxious' options (slightly more anxious/more anxious/much more anxious) and used as dichotomous data - those anxious per trial arm


NotesAim: to develop and test an Endodontic Decision Board for chairside use to help clarify treatment alternatives, benefits, risks, prognosis, and costs when root canal therapy or extraction of a tooth was indicated. The hypothesis was that the use of the EndoDB would lead to improved patient knowledge, greater satisfaction with the decision-making process, and no difference in anxiety when compared to the standard discussion and informed consent process (usual care)

Conclusion: patients in the EndoDB group demonstrated a small, but statistically significant increase in knowledge compared to the usual care group. There was no difference between groups in the measures of satisfaction or anxiety. Decision aids may emerge as a useful tool to facilitate SDM and evidence-based clinical practice


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation lists

Allocation concealment (selection bias)Low riskAllocation concealed from patients

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40% (3/70)

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskClinicians were not blinded and delivered consent for both arms of the trial

Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome responses labelled with participant information

Kain 1997

MethodsRCT-Anxiety was measured at 4 different time points-pre and post intervention, on day of surgery and after the child was taken into the operating room using STAI


Participants47 parents of 4 to 12 year olds undergoing elective surgery and a general anaesthetic. 23 in the intervention group and 24 in the control group

USA

Numbers of participants in analysis: 47

Intervention: 23

Control: 24


InterventionsIntervention was detailed anaesthetic information as opposed to control which was a leaflet containing standard anaesthetic information.The intervention contained statistics about adverse outcomes associated with anaesthesia

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: no details

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesAnxiety with the consent process: measured at 4 different points, used STAI-T and STAI-S at base line, and then STAI-S at T1 pre-anaesthetic interview, T2 after the intervention and T3 prior to surgery in the pre-op area and T4 after the child was taken into surgery

We have usedT2 for analysis. Data extracted from graph in the paper


NotesAim: hypothesized that the provision of detailed information about anaesthesia-related risk, including incidence of adverse outcome, is associated with increased parental anxiety

Conclusion: when provided with highly detailed anaesthetic risk data parental anxiety does not increase

Author contacted: yes, response for risk of bias table


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers table

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskResponse from author: doctor reading risks not blinded but all medical staff blinded. Patients not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskResponse from author: all personnel involved in outcomes were blinded

Kang 2009a

MethodsAssigned to 1 of 3 groups for patient-parent groups for patients undergoing orthodontic work. 45 minutes later after intervention delivery they were interviewed to check for understanding and recall

Data analysed for each intervention separately versus half of the control group

Presented in this table is information for Intervention A (MIC - Modified informed consent) versus Control group (AAO - existing consent form)


ParticipantsParents of patients aged between 12 to 18 years

USA

Numbers of participants in analysis: 44

Intervention: 29

Control: 15 (half of the control group)


InterventionsStandard consent was an American Association of Orthodontists informed consent form (AAO)

Intervention group A were given a modified informed consent form which was created from the AAO document and an existing informed consent document used already

Intervention development: modified from standardised information

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesUnderstanding: assessed by asking the parents to apply their knowledge to different scenarios to prove their understanding - qualitative analysis of transcribed interviews. Interviews were classified on a 1 to 4 scale and the outcome tools were previously validated and are reliable

Immediate knowledge: (45 minutes) as above

Anxiety with the consent process: STAI


NotesAim: to improve recall and comprehension

Conclusion: improving the readability of consent material made little difference, but combining improved readability and processability improved parents and patients comprehension and recall

Author contacted: yes, further information for risk of bias assessment obtained


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAuthor states "Randomised using Random.org. The allocation was then followed by stratification for age by year from 12-18. So, if allocation was to group A and the age group was filled, it was allocated to the next sequential group, B. The code book rater was blind to group allocation"

Allocation concealment (selection bias)Low riskResponse from author stating that allocation was concealed

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskResearch assistants collecting the data would have been aware of which group the patients were in and what the outcomes measured were (qualitative results)

Kang 2009b

MethodsAs follow on from Kang 2009aabove, intervention group B versus control:

Assigned to 1 of 3 groups for patient-parent groups for patients undergoing orthodontic work. 45 minutes later after intervention delivery they were interviewed to check for understanding and recall

Data analysed for each intervention separately versus half of the control group

Presented in this table is information for Intervention B (MIC + SS - Modified informed consent + slide show) versus control group (AAO - existing informed consent form)


ParticipantsParents of patients aged between 12 to 18 years

USA

Numbers of participants in analysis: 45

Intervention: 30

Control: 15


InterventionsStandard consent (control group) used the AAO (see above for details)

Intervention B used the modified consent form (details as above) and additionally had a narrated slide show presentation from power point with audio and visual cues representing the 18 elements of orthodontic informed consent

Intervention development: modified from standardised information

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesUnderstanding: assessed by asking the parents to apply their knowledge to different scenarios to prove their understanding - qualitative analysis of transcribed interviews. Interviews were classified on a 1 to 4 scale and the outcome tools were previously validated and are reliable

Immediate knowledge: (45 minutes) as above

Anxiety with the consent process: STAI


NotesAim: to improve recall and comprehension

Conclusion: improving the readability of consent material made little difference, but combining improved readability and processability improved parents and patients comprehension and recall

Author contacted: yes, further information for risk of bias assessment obtained


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAuthor states "Randomised using Random.org. The allocation was then followed by stratification for age by year from 12-18. So, if allocation was to group A and the age group was filled, it was allocated to the next sequential group, B. The code book rater was blind to group allocation"

Allocation concealment (selection bias)Low riskResponse from author stating that allocation was concealed

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskResearch assistants collecting the data would have been aware of which group the patients were in and what the outcomes measured were (qualitative results)

Langdon 2002

MethodsRCT, patients randomly allocated to standard verbal consent or standard verbal consent with written information


Participants126 patients undergoing hip arthroplasty were randomised. Were comparable at baseline based on age and previous hip arthroplasty

UK

Numbers of participants in analysis: 126

Intervention: 61

Control: 65


InterventionsWritten informed consent sheet vs standard verbal consent only. Information sheet contained a picture of total hip replacement and informations about the operation, hospital stay, types of implants and anaesthetic and risks

Control group was given structured verbal information during the consent interview (same information as that on the written document

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesLong-term knowledge: 18.5 days

Measured using MCQs


NotesAim: to ascertain whether written information sheets are acceptable to patients and improves recall of the consent interview

Conclusion: written information sheets contribute to the process of informed consent. As patients' recall of information is generally poor the sheets may also be useful medicolegally as a permanent record of what was discussed


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated random number

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessment was undertaken by blinded author

Lavelle-Jones 1993

MethodsRCT of patients undergoing surgery. All patients received standard consent, but half randomised to receive an operation information card


Participants265 Randomised patients undergoing intra-thoracic, intraperitoneal and arterial procedures. 130 randomised to intervention group, 135 randomised to control group. 192 completed study.

Dundee, United Kingdom

Numbers of participants in analysis: 253

Intervention: 126

Control: 127


InterventionsOperational Information card consisting of 3 items of information relating to the nature of the operation and 3 items on recovery, side effects and after treatment

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesImmediate, short-term and long-term knowledge: assessed at 5 time points:

  1. Admission interview, prior to seeing HO
  2. Within 1 hour of signing consent form
  3. On day of discharge (median = day 5, range = 1 to 92
  4. Out patients clinic at 4 to 6 weeks following discharge
  5. 6 months later


Assessed on scale of 0 - 6 according to the 6 items listed on the intervention cards, non-parametric data reported


NotesAim: to examine factor influencing quality of informed consent, using operation information cards

Conclusion: patients who received an operation information card were significantly better informed on the day of discharge only, but seemed to have no advantage immediately after the consent form was signed


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“Half were provided with operation information cards on a random basis. The randomisation was performed after entry into the study”

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskFull break down of patients analysed in each category at each time point. Control – 6 months = loss to follow up of 27%, intervention = 22.8%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Luck 1999

MethodsRCT looking at knowledge and general anxiety pre-colonoscopy


Participants150 patients scheduled for colonoscopy in a Day Surgery Unit (Jan to Aug 1998). Comparable at baseline-measured age, gender, education, previous colonoscopy.

Australia

Numbers of participants in analysis: 150

Intervention: 72

Control: 78


Interventions10-minute videotape discussing procedure then watching the procedure. Rated as medium quality. Sourced from Australian Gastroenterology Institute. All patients were given the standard surgical and anaesthetic information process before enrolment. (control + intervention) then the intervention group watched video

Intervention development: standardised information with no modifications

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesGeneral anxiety: about procedure (measured 1 week before colonoscopy and then on morning pre-op) using STAI, however results were only reported for patients that were severely anxious at baseline (STAI > 50). n = 16 intervention and 14 for control

Statistics note for general anxiety: the difference between the two groups pre-procedure rather than the change from baseline based on the information that the paper provided. We have used the excel spreadsheet to calculate the SD for both groups from the confidence intervals. To put into Revman we have subtracted the amounts from the total of 80 (max possible score on the STAI) to reflect that the intervention group were better with a lower score than the control group

Short-term knowledge: 1 week later. Tested with a questionnaire developed for the study asking about purpose, procedure details and potential complications on morning of colonoscopy (pre-op). SDs from the confidence intervals were calculated manually by the Review team


NotesAim: to assess the value of an information video in the provision of information before colonoscopy to improve knowledge and anxiety

Conclusion: an information video increases knowledge and decreases anxiety in patients preparing for colonoscopy

Author contacted: yes, confirmed severe anxiety measured with STAI scores > 50; no further raw data usable


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom shuffled cards

Allocation concealment (selection bias)Low riskThoroughly shuffled marked cards placed into sequentially numbered, sealed, opaque envelopes by clerical staff not involved in the rest of the trial

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll patients who reached the randomisation stage completed the trial

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskDifferent researcher marked the outcome and was blinded to the groups allocation

Makdessian 2004

MethodsRCT of patients attending an ambulatory facial plastic surgery centre comparing standard pre-surgery consultation with a standard pre-surgery consultation plus written pamphlet


Participants120 patients undergoing either rhinoplasty, face-lift surgery or laser resurfacing. paper fails to state if the groups were comparable at baseline, although age, gender and education level were measured

Canada

Numbers of participants in analysis: 120

Intervention: 63

Control: 57


InterventionsControl group had the standard initial consultation discussing nature, purpose, complications of the operation only. The intervention group had the same but in addition received a written pamphlet, however no clear information was actually given about its contents. Assumed that the information was to do with the risks that were orally discussed with the patients during the surgical consultation

Intervention development:designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesLong-term recall: median 15 days

Answers were obtained by telephone consultation with the patient and patients were asked to repeat the risks and complications of the particular procedure that was discussed during the intimal consultation with the surgeon. The answers were recorded on a standard checklist outlining the risks of that particular procedure


NotesAim: to evaluate the effectiveness of oral communication about the risks of facial cosmetic procedures compared with oral and written communication

Conclusion: written disclosure of the risks of cosmetic procedures enables patients to retain and understand more clearly those potential risks. They are, therefore, able to give informed consent to the proposed procedure


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation was via a computer generated die, even numbers placed into the intervention group and odd into control

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskAlthough patients were initially unaware they were participating in a trial, they were then informed before providing answers to the questionnaire

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; unclear whether the researchers performing the test were aware of the allocation of study groups

Mason 2003

Methods2 centre RCT comparing standard consent plus a video disk to standard consent alone


Participants38 women attending for planned sterilisation. 31 completed study

United Kingdom

Numbers of participants in analysis: 31

Intervention: 15

Control: 16


InterventionsVideo consisting of diagrams, text, shots of the QMC Day Theatre and laparoscopic equipment, as well as the presenter (VM) talking directly to camera. The programme lasted approximately 5 minutes

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesImmediate knowledge: non-parametric data

Anxiety with the consent process: non-parametric data


NotesAim: to test whether a video intervention in addition to standard consultation in women requesting sterilisation improves patient’s knowledge without increasing anxiety

Conclusion: women receiving video information as well as the standard consultation had significantly higher knowledge scores compared with women only receiving the conventional consultation. There were no differences in anxiety levels between the groups. Information giving by video was acceptable to the majority of women


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated randomisation programme

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants not blinded, personnel aware of content of video and that patient was participating in study, but not aware of if had seen video or not

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; no details in paper, response from author stated that they were blinded to intervention groups

Masood 2007

MethodsSingle centre RCT, comparing verbal consent with consent using the written standardised consent form (modified from BAUS)


Participants80 patients were randomised with no attrition. Patients were undergoing either TURP or TURBT for the first time. Unclear if patients were comparable at baseline, although "no significant difference in the mean ages." Age and sex comparable with no significant difference in social class stratification

Essex, United Kingdom

Numbers of participants in analysis: 80

Intervention: 35

Control: 45


InterventionsModified version of standardised consent form produced by BAUS-no information given on the modifications carried out. Given in addition to verbal consultation. Control group received verbal consent as per standard practice. Intervention quality-moderate

Intervention development: modified from standardised information

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesImmediate knowledge: before discharge but after procedure

Stats analysis: effect sizes for outcome 1 = knowledge were obtained by averaging percentages for the first 2 questions. These were rounded to integer values but note the percentages quoted in paper are not possible - ? attrition which not reported


NotesAim: to determine the degree to which patients understood the nature and risks associated with routine urological surgical procedures and whether providing additional detailed written information improved their understanding

Conclusion: verbal and written information supplied to a patient might be understood, but is easily and quickly forgotten. In an increasingly medicolegal environment, it is essential to gain informed consent from a patient before and intervention. The provision of an information booklet might provide nothing more than proof for the surgeon of information provided to the patient. Verbal and written information seems inadequate for obtaining informed consent, and the whole informed consent issue needs revisiting

Author contacted: yes, no further information or data accessible


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail; outcome measure completed before discharge so unlikely to have a high attrition rate

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Mauffrey 2008

MethodsRCT of patients scheduled for spinal surgery with the control group receiving a standard verbal discussion of the risks during and after the operation and the intervention group in addition to the verbal discussion were given a written A4 sheet reiterating the information given


Participants43 consecutive patients from a pre-op assessment clinic scheduled to undergo elective spinal surgery between February-November 2006. Participants were comparable at baseline with age, social class and education levels recorded

United Kingdom

Numbers of participants in analysis: 40

Intervention: 20

Control: 20


InterventionsInformative spreadsheet (A4 size sheet) containing a written explanation (identical to one provided verbally to both groups) of the risks during or after the operation

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesLong-term knowledge: 15 days

An A4 size questionnaire was given to the patients the day prior to their operation, about 2 to 3 weeks after the consent process. This questionnaire assessed whether patients remembered having been told about the various risks of surgery. For each of these risks the answer was yes, no, cannot remember or not applicable. This form was filled in by the specialist registrar himself to avoid having patients using their A4 explanation sheet to fill in the questionnaire


NotesAim: to assess the influence of written information provided to the patients during the consenting process on their recall of operative risks

Conclusion: the addition of a written sheet given to patients during the consenting process makes a significant difference in terms of their recall of the surgical risks in elective lumbar spine surgery

Author contacted: yes, information available to aid assessment of risk of bias


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskSequence generation was done using the last digit of the hospital number: odd/even (information was obtained from contact with author)

Allocation concealment (selection bias)High riskRisk of allocation prediction due to use of odd or even hospital record numbers

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Typing error within the published paper was reported following contact with author, therefore no-one was excluded. 43 is the correct number enrolled in the study

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskPossibility that patients could have obtained information sheets from the other patients, contamination

Blinding of participants and personnel (performance bias)
All outcomes
High riskPersonnel not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome measurements were done by the registrars who delivered the intervention

Mishra 2010a

MethodsAs follow on from Mishra 2010babove, intervention group B versus control:

RCT with two intervention groups and one control. Patients' outpatient consultation with the surgeon was recorded, then patients either received one of the intervention audio-cassettes or received standard care


Participants84 elective first time CABG at a tertiary health centre under the care of one surgeon. Participants were comparable at baseline, according to age, gender, ability to speak English, NART score and Area of Deprivation Index

United Kingdom

Numbers of participants in analysis: 38

Intervention: 24

Control: 14 (half of the control group)


InterventionsAll participants were audio-recorded at their outpatient appointment with the surgeon. Following this: the second intervention group (intervention generic) received a generic tape containing information about CABG, scripted to include information covering each of the domains described by the GMC. Both groups received a letter encouraging them to listen to the tapes as many times as they wished and with others

The control group did not receive any tape

Intervention development: designed for trial with no validation

Exposure: multiple exposures to the same intervention

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: audio-recorded consultation and audio-tape with standardised information

Time of delivery: before admission


OutcomesLong-term knowledge: length of time not stated, following discussion in meeting 30/3/12 decided that it was long term as likely to be > 2 weeks between outpatient appointment and CABG

General anxiety: measured using the HAD questionnaire (scale 0 to 21) at presumed to be measured on admission for CABG


NotesAim: to evaluate the effect of audio-taping outpatient consultations on informed consent for cardiac surgery

Conclusion: providing an audio-taped recording of the consultation before cardiac surgery appears to improve patients knowledge and perceptions of control of their health status and to reduce anxiety and depression

Author contacted: yes, further information used to assess risk of bias


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients were randomised by minimization using age and sex as stratification factors-computer programme used

Allocation concealment (selection bias)Unclear riskContact with author "allocation was by the computer generated software"

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskAll consultations were recorded so that the patients and surgeons were blinded to which arm of the trial that they were in. However the patients were then sent a tape therefore blinding not robust

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPersonnel administering and assessing the outcome measurements were blinded

Mishra 2010b

MethodsRCT with two intervention groups and one control. Patients' outpatient consultation with the surgeon was recorded, then patients either received one of the intervention audio-cassettes or not at all

Data analysed for each intervention separately versus half of the control group

Presented in this table is information for Intervention A versus control group


Participants84 Elective first time CABG at a tertiary health centre under the care of one surgeon. Participants were comparable at baseline, according to age, gender, ability to speak English, NART score and Area of Deprivation Index

United Kingdom

Numbers of participants in analysis: 38

Intervention: 24

Control: 14 (half of the control group)


InterventionsAll participants were audio-recorded at their outpatient appointment with the surgeon. Following this: one group (intervention consultation) received an audio tape of their consultation with the surgeon

The control group did not receive any tape

Intervention development: designed for the trial with no validation

Exposure: multiple exposures of the same intervention

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: audio-recorded

Time of delivery: before admission


OutcomesLong-term knowledge: length of time not stated, following discussion in meeting 30/3/12 decided that it was long term as likely to be > 2 weeks between outpatient appointment and CABG

General anxiety: measured using the HAD questionnaire (scale 0 to 21) at presumed to be measured on admission for CABG


NotesAim: to evaluate the effect of audio-taping outpatient consultations on informed consent for cardiac surgery

Conclusion: providing an audio-taped recording of the consultation before cardiac surgery appears to improve patients knowledge and perceptions of control of their health status and to reduce anxiety and depression

Author contacted: yes, further information used to assess risk of bias


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients were randomised by minimization using age and sex as stratification factors-computer programme used

Allocation concealment (selection bias)Unclear riskContact with author "allocation was by the computer generated software"

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasUnclear riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskAll consultations were recorded so that the patients and surgeons were blinded to which arm of the trial that they were in. However the patients were then sent a tape therefore blinding not robust

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPersonnel administering and assessing the outcome measurements were blinded

Morgan 2000

MethodsRCT using questionnaire at time of treatment decision to measure knowledge and satisfaction, and follow-up data at 6 months to assess rate of uptake


ParticipantsPatients with ischaemic heart disease who could be treated by either elective revascularization or medical therapy. 279 eligible participants, of whom 39 were excluded. 120 were randomised to intervention and 120 to control. 53 patients either withdrew or were lost to follow up

Toronto, Canada

Numbers of participants in analysis: 181

Intervention: 86

Control: 95


InterventionsInteractive videodisc presenting information about the risks and benefits associated with the three treatment alternatives for IHD; medical therapy, angioplasty or bypass surgery

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent

Done with clinician?: face-to-face

Intervention type: multiple interventions including decision aid

Time of delivery: before admission


OutcomesPatient satisfaction with decision making process: 12 point MCQ, reported as percentage score. Confidence Interval for difference is reported and is non-symmetrical, indicating unequal variance between groups. We've matched P value as opposed to Confidence Interval (usablestat.com)

Immediate knowledge: 20 true/false questions, reported as percentage of correct answers. Confidence Interval is symmetrical for this outcome. We have matched P value and Confidence Interval (usablestats.com)

Rate of uptake: using measurement of patients who had revascularisation by 6 months

'Bodily pain' was also measured at 6 months - but not used for our review - as is a measure of generalised pain, rather than pain from the procedure being considered


NotesAim: to determine the effect of the IHD shared decision making program, an interactive video disc, designed to assist patients in the decision making process involving treatment choices for IHD on patient decision making

Conclusion: no significant difference in satisfaction with the decision making process scores between the IHD shared decision program and usual practice groups. the IHDSDP groups were more knowledgeable, underwent less revascularisation and demonstrated increased patient decision making autonomy without apparent impact on quality of life

See notes on standard deviation calculations in outcome section above

Author contacted: yes, further information available for risk of bias assessment


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskTwo randomisation schedules and a blocking factor

Allocation concealment (selection bias)Low riskDone by statistician over the phone who was the only person privy to the information

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskFollowing email contact with author: neither the investigators nor the patients were blinded to the intervention, the angiographers may have known about the allocation

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Nadeau 2010

MethodsSingle centre RCT with one control and one intervention group (handout)


Participants34 Military parents of children undergoing ENT surgery (tonsillectomy and adenoidectomy or bilateral myringotomy with tympanic tubes. All completed study. Comparable at baseline

USA

Numbers of participants in analysis: 34

Intervention: 16

Control: 18


Interventions2-stage intervention:

Stage 1 = consented with a surgical risk sheet prompt in the intervention group (procedure specific for either tonsillectomy or ear tubes). Control group had consultation without prompt

Stage 2 = general surgical sheet (operative instructive sheet) given to intervention group and control group to take home

Source and content of sheets not stated

Unclear quality assessment - no information available to make judgement

Intervention development: no details

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesImmediate and short-term knowledge: recall of 9 specific risks of surgery (T1 = post-consent at time of intervention, and T2 = post-op on day of surgery - mean 6.3 days, range 1 to 22 days after intervention). Note, this was measured immediately after surgery

Secondary: general knowledge on a test - scored as percentage correct answers, no information on what questions asked or style of test. This outcome measure would be included under same ‘Secondary Outcome Measure’ for our review as the previous recall of 9 risks was. Since the Risk recall was the primary outcome of Nadeau et al, we are using the data from that outcome rather than this ‘General Knowledge Test’ outcome


NotesAim: investigate parent understanding of risks of paediatric surgery after counselling with/without use of an information leaflet

Conclusions: parents of children undergoing ENT surgery recall far less than 100% risks. The use of detailed surgical risk counselling aids can improve measured parental risk recall

Author contacted: yes, further information available to assess risk of bias


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised by numbered card technique (from email correspondence: "Groups stratified by type of procedure consenting for before randomisation")

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Neary 2010

MethodsRCT comparing an interactive website to a control website


Participants81 eligible Patients undergoing minimally invasive radio guided parathyroidectomy, of whom 51 completed the trial.

Ireland

Numbers of participants in analysis: 51

Intervention: 31

Control: 20


InterventionsThe use of an interactive individualised online patient pathway. This presented the patient with a clear stepwise description of their expected clinical course, from initial diagnosis at their general practitioner’s surgery to eventual discharge from the hospital. There was the option of requesting more information if required, and if dissatisfied with results, the option of email a consultant for further information

Control consisted of a web site with only limited information such as patient name, date of birth, address, and background information about the surgeon and hospital as is available via the standard hospital web site

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: interactive multimedia

Time of delivery: before admission


OutcomesGeneralised anxiety: using HAD scale , evening before surgery

Pain levels: post-op pain measured on VAS

Analgesia use: analgesia requirements as defined by intervals on WHO pain ladder

Satisfaction with the consent process: with capacity to consent measured by total score to 6 questions using a Likert scale ranging from 1 to 5, 5 = Strongly Agree. Gives non-parametric data

Perception of website utility, measured by 9 questions on 5-point Likert scales


NotesAim: to determine the usefulness of an interactive, individualized online patient pathway to patients undergoing elective operation for nonmalignant disease

Conclusion: this study demonstrates the proof of concept of the subjective usefulness of web-based information for patients in the preoperative period. Although it did not influence patient anxiety or analgesic requirements, the novel online, interactive patient pathway makes a positive impression on our patients’ journey through the healthcare system and so would seem to provide added value to the overall experience


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAssigned by permuted block randomisation, randomisation was performed by a person not involved in recruitment or data collection and the recruiter and interviewer were not aware that the study was block randomised prior to its completion

Allocation concealment (selection bias)Low riskThe recruiter and interviewer were not aware that the study was block randomised prior to its completion

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%. 64 eligible, with 13 excluded due to not accessing website = 51 included in analysis = 80%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Low riskPatients and all study personnel were blinded as to which group patients were allotted. Patients were informed only that the website they accessed would give them basic details about the surgery and were provided with a username and password that allowed access to their allotted website

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOnly after study was completed were the group composition and assessments revealed to the study authors

Neptune 1996

MethodsRCT comparing the same consent form for IV pyelogram or IV contrast CT, delivered either 24 to 72 hours prior to procedure in intervention group, or 15 to 60 minutes prior to procedure in control group


ParticipantsPatients undergoing IV pyelogram or IV contrast CT. 80 patients in both groups - from 160 consecutive out-patients awaiting the relevant diagnostic test

Pennsylvania, USA,

Numbers of participants in analysis: 160

Intervention: 80

Control: 80


InterventionsIntervention group received their contrast information sheet by post 24 to 72 hours prior to radiology appointment. The same information was provided 15 to 60 minutes prior to the diagnostic procedure in the control group. Intervention group were telephoned to check they had received the information sheet, and were willing to read it. The form had been published previously by the same authors - and was designed for 8th grade reading level

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent

Done with clinician?: face-to-face

Intervention type: alteration of timing

Time of delivery: intervention group consented before admission and control group consented on admission


OutcomesImmediate knowledge: assessed by 7 question questionnaire administered in the radiography department, after receiving intervention or control, and signing consent form, but before scan

Satisfaction assessed via a questionnaire - no details given, data not extractable for this outcome


NotesAim: to improve knowledge & satisfaction by providing informed consent form 24 to 72 hours prior to appointment for IV pyelogram or IV contrast CT

Conclusion: providing informed consent 24 to 72 hours in advance of diagnostic procedures did not improve knowledge and satisfaction


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated randomisation

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%; paper states that approximately 10% of intervention group patients were disqualified from study as could not be reached, denied receipt of information sheet or were reluctant to read information. No n values given for analyses, so unclear whether 72 included in analysis, or 89 initially recruited (i.e. < 40%)

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

O'Neill 1996a

MethodsSingle-centre RCT of patients scheduled to undergo wisdom tooth removal. Comprised of four groups, wisdom tooth leaflet (WTL) prompt by dentist to read the leaflet versus WTL only. Two control groups, one group were given a leaflet on dental health education and the other control group were given nothing. It was decided that the control group who were given the leaflet were to be excluded because this did not represent normal treatment. Control group two was therefore split between the two intervention groups

Data analysed for each intervention separately versus half of the control group

Presented in this table is information for Intervention WTL versus half of the control group


Participants66 patients were randomised into 4 groups. Patients were comparable according to age, sex and exodontia. All patients referred to the university hospital for surgical removal of wisdom teeth under local anaesthesia were invited to take part in the study. No exclusion criteria given

Liverpool, United Kingdom

Numbers of participants in analysis: 26

Intervention: 18

Control: 8


InterventionsIntervention 2 was a wisdom tooth leaflet only (WTL)

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesImmediate knowledge: approximately 2 weeks prior to treatment

Satisfaction with the consent process: questionnaire 1 to 7 (1 extremely satisfied, 7 extremely dissatisfied)


NotesAim: to determine the effect of an information leaflet on patients' knowledge of wisdom tooth removal and to assess satisfaction with the information supplied to patients attending the Oral Surgery Department

Conclusion: the WTL and prompt group showed increased knowledge on retest. The WTL group showed a trend greater knowledge, however the control groups showed no improvement. Patient satisfaction, although greatest in the group given a leaflet without prompting, was not simply related to leaflet provision


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail; states 'randomised'

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail; unclear how many initially randomised and then lost

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskPossibility of contamination

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; unclear who the outcome assessors were

O'Neill 1996b

MethodsSingle-centre RCT of patients scheduled to undergo wisdom tooth removal. Comprised of four groups, wisdom tooth leaflet (WTL) prompt by dentist to read the leaflet versus WTL only. Two control groups, one group were given a leaflet on dental health education and the other control group were given nothing. It was decided that the control group who were given the leaflet were to be excluded because this did not represent normal treatment. Control group two was therefore split between the two intervention groups

Data analysed for each intervention separately versus half of the control group

Presented in this table is information for Intervention WTL and prompt versus half of control group


Participants66 patients were randomised into four groups. Patients were comparable at baseline according to age, sex and exodontia. All patients referred to the university hospital for surgical removal of wisdom teeth under local anaesthesia were invited to take part in the study. No exclusion criteria

Liverpool, United Kingdom

Numbers of participants in analysis: 24

Intervention: 16

Control: 8


InterventionsIntervention 1 was a wisdom tooth leaflet plus prompting by the dentist to read the leaflet (WTL and prompt)

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesImmediate knowledge: approximately 2 weeks prior to treatment

satisfaction with the consent process: questionnaire 1 to 7 (1 extremely satisfied, 7 extremely dissatisfied)


NotesAim: to determine the effect of an information leaflet on patients' knowledge of wisdom tooth removal and to assess satisfaction with the information supplied to patients attending the Oral Surgery Department

Conclusion: the WTL and prompt group showed increased knowledge on retest. The WTL group showed a trend greater knowledge, however the control groups showed no improvement. Patient satisfaction, although greatest in the group given a leaflet without prompting, was not simply related to leaflet provision


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail; states 'randomised'

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskPossibility of contamination

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; unclear who outcome assessors were

Olver 2009

MethodsRCT


Participants101 participants were randomised, all of whom were to undergo chemotherapy. Patients who were chemotherapy naive who were not involved in clinical trials. Over 18 yrs, life expectancy of at least 12 weeks, English speaking, ability to provide consent. Participants were comparable at baseline, with age, gender, nationality, level of education and occupation measured

Adelaide, Australia

Numbers of participants in analysis: 101

Intervention: 47

Control: 54


InterventionsCD ROM for intervention group versus written information for controls. The CD-ROM was locally produced using the clinical researchers and local media. Content included the same information as the standard information sheet and consent forms about the treatment, however included additional information about cancer and its treatment. Not validated and only 28% of those using the CD-ROM felt that they understood all the information. The control group had written information before signing the consent form about which no details were provided

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinical

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesLong-term knowledge: 3 to 4 weeks after intervention/consent consultation

Statistics note on long-term recall data: took the median value for 3 different recall assessments (correct recall of number of drugs instead of recall of treatment length or recall of treatment goal)

Generalised anxiety: HADs score at 3 to 4 weeks but not presented for individual trial arms in report. Raw data available for each trial arm from authors on request

Satisfaction with the consent process: Dichotomous data but not presented for individual trial arms in report. Questionnaire at 3 - 4 weeks asking how helpful was the CD ROM? Answers were Very helpful, somewhat helpful, unhelpful, unnecessary or can't remember. Helpful and very helpful were grouped together for a positive response. Raw data available for each trial arm from authors on request


NotesAim: to determine whether an interactive CD-ROM improved cancer patients’ recall of chemotherapy treatment information over standard written information, and whether demographic, cognitive, and psychological factors better predicted recall than this format of delivery

Conclusion: an interactive CD-ROM did not improve cancer patients' recall of treatment information enough to warrant changes in consent procedures

Author contacted: yes, raw data available for outcomes 'generalised anxiety' and 'satisfaction with the consent process' - see meta-analyses


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskData managers performed randomisation using odd/even hospital identification numbers

Allocation concealment (selection bias)High riskAble to predict allocation due to method of quasi-randomisation

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up. Flow-diagram page 199 (fig 1) clearly shows intention-to-treat and what happened to other patients after recruitment. However, no comment on how authors undertook ITT

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskIntervention not concealed for nursing staff who gave the patients the CD-ROM or written information. Nurses were responsible for giving the majority of information to over 30% patients, therefore not blinding may introduce bias. Patients not concealed since consented to study, but interviewed individually by Psychologist administered tests. Clinicians were blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskNurses giving out the CD-ROM or written information are 'the principle nurses involved in treating the patient' that record the patient's recall for the primary outcome measure. Since they are recording a binary 'correct' or 'incorrect' recall outcome, this leads to high risk of bias of outcome assessment

Paci 1999

MethodsDay before surgery patient was seen as outpatient. Patients unaware they were enrolled in a study and the nurse gave them a list of questions to ask in the consultation. The doctors recorded how many of the questions the patients asked and the type of anaesthetic was recorded. Patients were called 2 weeks later asked about satisfaction


ParticipantsPatients attending for minor surgical procedures, ASA I and II; varicose vein stripping, inguinal herniorrhaphy, haemorrhoidectomy, trans-urethral resection of the prostate, or hydrocelectomy

Numbers of participants in analysis: 112

Intervention: 50

Control: 62


InterventionsList of seven questions designed to facilitate the patients active engagement in the medical encounter was given to the patient prior to seeing the doctor. Patients were asked to think about these and ask any questions they thought relevant

Intervention development: no details

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: prompt questions

Time of delivery: on admission


OutcomesRates of uptake: percentage of patients that choose general anaesthetic as opposed to regional anaesthetic

Desire for further information: assessed by patient responses to 'did you think of any other questions you would have liked to have asked?'

Satisfaction with the consent process: (yes/no answer - dichotomous data) telephone interview 2 weeks after surgery


NotesAims: to assess an intervention aimed to facilitate the patient’s active engagement and satisfaction in the medical encounter

Conclusion: method did not change proportion who chose specific anaesthesia, but does seem to improve patient participation in decision making process. Satisfaction unchanged


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskCluster randomisation by day of visit was performed

Allocation concealment (selection bias)High riskAllocation was not concealed to the anaesthetists as the patients brought along their lists of questions. P164 column 2 last paragraph. Patients however were unaware they were in a trial

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%; 73 patients in control group, 52 in survey group. 11 patients in control group (15%) and 2 (4%) in the survey group were unable to be reached for telephone interviews. No evidence of exclusion from analysis

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants were unaware they were in a trial – completely blind

Personnel were not blind as patients in study group brought along their question list

The anaesthetists all said they would prefer regional anaesthetic so may have influenced consultation

Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe post operation telephone interview was blind with regard to the patient group

Pesudovs 2006

MethodsRCT with patients being assigned to either standard verbal consent, where the clinician used a standardised information sheet which explained the risks and benefits of cataract surgery or the same verbal consent with the addition of a take home copy of the information sheet


Participants50 patients undergoing elective cataract surgery who completed the study, unclear how many were initially eligible

Australia

Numbers of participants in analysis: 50

Intervention: 24

Control: 26


InterventionsFor the control group, they were consented verbally using an information sheet explaining the risks and benefits of cataract surgery. This was written in as simple terms as possible, minimising jargon, and including all important content areas for cataract surgery informed consent

The reading age of the information was independently assessed to be 8 years of age

The intervention group received the same consent, but were issued a copy of the information sheet to take home

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesImmediate and long-term knowledge: assessed using eight multiple choice questions. Administered immediately and at average of 79 days, standard deviation of 53 days after pre-op completion. Seven questions were dichotomous, correct versus Incorrect (Q 2, 6, 7, 8, 9, 10a & 10b). To enter data for this review, the median effect size was calculated by ranking the difference between written information and no written information from the greatest positive change to the greatest negative change and the Median effect size calculated. This was Q9 for Immediate knowledge and Q6 for long-term knowledge. Q11 was a continuous measure of number of risks recalled of a possible 5, expressed as percentage of group. To enter this data that original N values were calculated for "Number of risks recalled" and from this the "average number of risks recalled" was calculated

Satisfaction with consent process: measured using three multiple choice questions, (Q 3,4 & 5). These were dichotomised (Q3: enough = satisfied, too much/too little = not satisfied. Q4&5: yes = satisfied, no = not satisfied) and a median effect size was calculated. Satisfaction was measured immediately and at long term. For review have entered immediate data as fewer confounding factors


NotesAim: to investigate the effect of giving written material on information recall from informed consent counselling for cataract surgery

Conclusion: patient’s ability to recall information provided during the informed consent process is poor. Recall deteriorates with time after surgery and is not improved by the provision of written material

Author contacted: yes, no further data available


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskAllocation by hospital number (even numbers given written consent) - quasi-randomisation

Allocation concealment (selection bias)High riskNo concealment as by hospital number

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskLarge range of time for follow-up questionnaire completion (average of 79 days, SD of 53 days)

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded - they were aware of the interventions delivered

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; no comment on blinding of outcome assessment, but questionnaires completed by unblinded patients

Phatouros 1995

MethodsPilot RCT comparing two information leaflets for angiography and angioplasty, one detailed and one basic. Outcomes assessed by nurse post-procedure


Participants100 patients in an in- or out-patient setting at an acute care hospital, due to undergo angiography or angioplasty. 81 completed the study

Numbers of participants in analysis: 65

Intervention: 29

Control: 36


InterventionsControl group received basic information sheet, providing no information regarding specific complications - but advised this could be discussed if the patient required. Intervention group received a longer information sheet providing identical information, but included information detailing possible complications or the procedure, and those of IV contrast administration - including mortality rate

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesAnxiety with consent process: patients response to question regarding whether information provided made them more anxious - measured on single Likert Scale. Results dichotomised by authors into agree/disagree that more anxious, data for 'don't know' excluded by us (but reported by authors)

Rates of uptake: treatment uptake rate – paper reported that overall 3 participants did not have test, however, breakdown between groups not provided, so data not usable for review

Satisfaction with consent process: measured by three Likert scale questions

Desire for further information: single Likert Scale question

N.B. For all dichotomous outcomes have excluded 'don't knows' - although they were reported in paper

Paper also measured patients self reported increased likelihood of cancelling procedure - decided not to include as hypothetical treatment uptake rate not realistic. Whether extra time taken to answer patients questions (as reported by "proceduralist"). Paper states “Two patients from each group required specific information of the proceduralist. This took less than 5 min in each case". No assessment of how long the consent process was in general and impact 5 min made, so not extractable for this review


NotesAim: to test levels of risk disclosure with respect to anxiety, usefulness of information and treatment uptake rates

Conclusion: information sheets were well accepted and provide a practical way of disseminating advice on procedure protocol, and adverse outcomes. Furthermore, the provision of extra information on adverse outcomes did not lead to a statistically significant increased level of subjective reported anxiety or risk of procedural cancellation


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail; patients were randomised - but no further details given

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%; 81% response rate

Selective reporting (reporting bias)High riskNot all stated outcomes reported - did not include all data e.g. extra time taken; whether information was useful

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Raynes-Greenow 2010

MethodsRCT, outcomes assessed at baseline, 1 week following intervention and 12 to 16 weeks post-partum


ParticipantsPregnant women 37 weeks gestation, prior to entering labour. 627 were approached, 31 refused, 596 randomised. 395 intervention, 201 control at baseline - 349 intervention, 178 control at 1 week - 308 intervention & 146 control 3 months post-partum. Participants were divided between 2 obstetric hospitals, enrolled Sept 2004 - April 2006

Australia

Numbers of participants in analysis: 596

Intervention: 395

Control: 201


Interventions55 page decision aid, with or without audio guide, and four A3 page workbook, which women were given to take home and use. Content was information on analgesia options in labour

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent with special leaflet

Done with clinician?: face-to -face

Intervention type: multiple interventions and decision aids

Time of delivery: before admission


OutcomesDecisional conflict: self-administered decisional conflict scale (DCS) validated & reliable questionnaire at baseline, 1 week after intervention (38 weeks gestation) and 3 months post-partum. We used 1 week data

Short-term knowledge: 16 true/false questions at baseline, and 1 week after intervention. Questions related to general knowledge about labor analgesia risks & benefits. Questionnaire not validated

Generalised anxiety: state component of short Spielberger anxiety scale (20 to 80, 20 = low anxiety), at baseline, 1 week & 3 months post-partum. We used 1 week data as generalised anxiety outcome

Satisfaction with decision making: using validated satisfaction with decision scale at 1 week and 3 months. (SWD validated scale used) Expressed as percent satisfied in a continuous manner

Desire for further information: yes/no question "Enough information to make the decision?" at 1 week

Rates of uptake: extracted from routinely collected hospital database. Percentage who had an epidural used for this review

NB: that study design gave info to all women who were 37 weeks gestation, and had outcome data for all of them - not everyone in the study did, or would have been expected to, go on an have an invasive intervention e.g. epidural. This makes interpretation of scores difficult - was 'having an epidural' a favourable outcome or not?

Sense of control: at 3 months, a 'participation in decision making' scale used - patients chose one of 5 statements - either 'I chose by myself' 'I chose after seriously considering my care-providers opinion' ' shared decision with care-providers' 'care provider made decisions' 'other'. We summed first 3 options as patient locus, and last 2 as physician locus of control (following D/W statistician)


NotesAim: to test the effectiveness of a decision aid for labour analgesia for primiparous women

Conclusion: decision aid improved women's labour analgesia knowledge, without increasing anxiety. Significantly the decision aid group were more informed of labour analgesia options and considered the options of their care-providers more often when making their decisions, thus improving informed decision making


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRemote telephone randomisation generated by computer using random variable block sizes

Allocation concealment (selection bias)Low riskAllocated at remote location

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%. 1st follow-up overall response rate was 88%, with no significant difference between the two groups. At 2nd follow-up overall response was 78%, with no significant difference between groups

Selective reporting (reporting bias)Low riskProtocol published and checked, all outcomes reported

Other biasLow riskAuthors combined two arms of intervention groups, but had pre-specified this in protocol, so deemed not to introduce a high risk of bias

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants consented but most women who received control pamphlet didn't know it wasn't the intervention. Usual antenatal care providers trained on study protocol and risks of contamination, and blinded to content & format of the decision aid

Blinding of outcome assessment (detection bias)
All outcomes
Low riskResearchers were kept blinded to intervention allocation as much as possible. Research assistant followed an interview protocol at each follow-up, and had been trained in the implementation of keeping the follow-up standardised regardless of intervention allocation

Rossi 2004

MethodsRCT comparing video information to standard verbal consent for patients undergoing surgical management of closed ankle fracture, at 2 acute care centres


Participants48 consecutive patients from the 2 centres, enrolled over 9 months, or whom 100% completed initial follow-up, and 77% completed 10-week follow-up.

USA

Numbers of participants in analysis: 48

Intervention: 23

Control: 25


Interventions9-minute video including information on risks, benefits and alternatives to treatment, as well as a description of the procedure, pertinent anatomy of the ankle, post-operative care and follow-up, possible complications and supplemental visual aids. Assessed using the Fry formula for readability, which detected a 7th grade reading level

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audiovisual

Time of delivery: on admission


OutcomesImmediate and long-term knowledge: knowledge assessed by a 12 MCQ questionnaire immediately after consent intervention, and at a mean of 9.8 weeks post-surgery (range 3.7 to 20.0 weeks)


NotesAim: to evaluate the effectiveness of a video tape information over standard verbal consultation in terms of knowledge for informed consent of ankle fracture surgery.

Conclusion: patients who received information about their surgery on a video tape before giving their consent demonstrated a significant increase in knowledge recall compared to those consented verbally alone. It is unclear if the difference noted in this study is based on a presentation that is easier to understand or exposure to more accurate information given during the consent process

SD for knowledge scores calculated using "usablestats.com" (assumed SD for intervention/control were the same)

Author contact: no further data available


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail; block randomisation by educational level, no details

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%; 100% initial follow-up, 23% lost to follow-up at 10 weeks

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskPersonnel who provided consent information were aware that a study was being conducted, but blinded to content of video

Participants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskData analysed by an independent statistician blinded to the study and control groups

Rossi 2005

MethodsRCT-single centre. Comparing patient comprehension and satisfaction with informed consent when using a video vs verbal discussion.


Participants152 eligible of which 150 were randomised, undergoing knee arthroscopy under a single surgeon. Patients were comparable at baseline, age, gender, ethnicity and social characteristics recorded. Baseline characteristics: stratified for educational level below and above 12th grade in analysis (prior to randomisation)

Taos, USA

Numbers of participants in analysis: 180

Intervention: 73

Control: 77


InterventionsVideotape prepared by the American Academy of Orthopaedic surgeons and National Association Orthopaedic nurses. Title: Arthroscopic knee surgery: return to action. Intervention was watched in a "patient education room" and a orthopaedic technologist or a physicians assistant provided unlimited time for patients to ask questions and sign a consent form

Control group received conventional verbal consent (included unlimited question time) before signing a consent form.

Intervention ranked as moderate to high quality

Intervention development: standardised information with no modifications

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: on admission


OutcomesImmediate knowledge: Statistics note for immediate knowledge: using percentage scores in continuous data for immediate knowledge, but note that not normally distributed (with 2 SDs being over 100%)

Satisfaction with consent process


NotesAim: to test the hypothesis that video informed consent improves knee arthroscopy patient comprehension and satisfaction compared with traditional verbal informed consent

Conclusion: video informed consent improves knee arthroscopy patient comprehension compared with traditional verbal informed consent

Author contacted: yes, but no further data available


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatient data collection packages (containing demographic forms and an outcome questionnaire) were labelled as video or verbal in equal numbers for each subgroup, shuffled face down, and picked from the top of a stack for each patient who was entered into the study

Allocation concealment (selection bias)High riskHigh risk of bias if researcher wanted to pick which one to give to the participant

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%; 2 participants dropped out

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Rymeski 2010

MethodsRCT using an Internet based aid to look at the rate of recall of nine surgical complications


Participants30 parents of children having elective inguinal hernia repair or hydroceles in an outpatient clinic. 30 included in analysis. Similar for age

USA

Numbers of participants in analysis: 30

Intervention: 17

Control: 13


Interventionsan Internet programme called EMMI which parents were given a code to access over the Internet after a preoperative clinic before surgery around one month later

Intervention development: standard information with no modifications

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesLong-term knowledge: recall of 9 complications of surgery measured approximately one month after the intervention, results collected on a blank sheet

Statistics note: taken comparison at time point 2 instead of change over time in score. Using the P value of 0.06 and the excel spreadsheet SD calculated as 1.93


NotesAim: to examine the effect of an Internet based aid to informed consent on parent recall of potential surgical complications

Conclusion: although overall recall of potential surgical complication was poor in both groups, there was a trend towards a significant improvement in recall in the study group after viewing the Internet based programme


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskOdds/even system based on the last digit of the patients medical record number - quasi-randomisation

Allocation concealment (selection bias)High riskPredictable randomisation due to the sequence generation method

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Staff were aware of allocation

Blinding of outcome assessment (detection bias)
All outcomes
High riskDid not blind the marker of the recall sheets

Shorten 2005

MethodsRCT, intervention delivered at 28 weeks. Women were surveyed on knowledge and decisional conflict at 28 weeks and again at 36

Rate of uptake- preferred preference for birth was recorded at 36 weeks and then compared to actual method of delivery


ParticipantsPregnant women who had previously had a caesarean section and considering method of delivery of subsequent pregnancies (either for a trial of labour or an elective caesarean section)

252 eligible participants, 115 randomised to the intervention and 112 to the control. At follow up at 36 weeks - 92 in the control group replied and 99 in their intervention group. For follow up for the decisional conflict score 99 in the intervention group and 88 in the control group had details recorded

Australia

Numbers of participants in analysis: 191

Intervention: 99

Control: 92


InterventionsDecisional aid booklet using the Ottawa decision framework as a format and incorporating evidence based information, explicit probability illustrations and values clarification exercises

Intervention development: designed for trial with reasonable efforts for validation/piloting

Exposure: two exposures and two different interventions

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: no details

Done with clinician?: distant without clinician

Intervention type: decision aid

Time of delivery: before admission


OutcomesLong-term knowledge: change in score between 28 (before intervention given)and 36 weeks therefore long term (8 weeks) difference in knowledge reported as mean difference

Decisional conflict - decisional conflict scale was used, a score out of 5, change in score between 28 to 36 weeks was reported

Rates of uptake: caesarean section or trial of labour were reported for each group. Results of a preferred elective caesarean section were reported as the invasive option


NotesAim: to determining if a decision aid about mode of birth after a caesarean section facilitates informed decision-making about birth in subsequent pregnancies

Conclusion: a decisional aid for women facing choices about birth after caesarean section is effective in improving knowledge and reducing decisional conflict. However, little evidence suggested that this process led to an informed choice


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated randomised numbers

Allocation concealment (selection bias)Low riskOpaque envelopes containing a random allocation for each participant

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasUnclear riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; measured by questionnaire, unclear if anonymised

Solberg 2010

MethodsCluster randomised controlled trial comparing an extensive intervention to standard care. Block randomised between eight centres


ParticipantsWomen considering treatment options for uterine fibroids, 526 assessed for eligibility, 226 were excluded as asymptomatic/incidental fibroids or as the participant had already made their treatment choice. 300 were randomised to 136 for the intervention and 164 for the control group. 24 from the intervention group and 32 from the control group were either lost to follow up or excluded because of language barriers. 112 were analysed in the intervention group and 132 in the control group. These values differ from the N values stated in the tables so the author was contacted. Difference due to skip patterns within the administered questionnaires (Intervention 103 and control 112)

USA

Numbers of participants in analysis: 215

Intervention: 103

Control: 112


InterventionsControl group had information sheets and normal care, no extra decisional support

The ICA intervention included the following components:

  1.  Patient decision aids: DVD and booklet from the Foundation for Informed Medical Decision Making (FIMDM) describing the treatment options for fibroids, the advantages and disadvantages of each, and illustrating how different women work with their doctors to choose the fibroid treatment that is best for them
  2. Decision worksheet: paper copy of a generic version of the Ottawa Decision Guide, designed to help identify the relevant options, the key pros and cons, values, and preferred decisions
  3. Nurse coach access: the phone number to call to obtain help from a nurse counsellor trained in using the Ottawa Guide with patients. If no call was received within 2 weeks, the counsellor was to call each patient to facilitate access to counselling


Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: two exposures and two different interventions

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and standardised leaflet

Done with clinician?: face-to-face

Intervention type: multiple interventions including decision aids

Time of delivery: before admission


OutcomesLong-term knowledge: knowledge score out of 5 measured 4 to 5 weeks following consultation

Satisfaction with decision making: measured 4 to 5 weeks following the consultation (5 point Likert scale: 5 = satisfied)

Sense of control: measured at 4 to 5 weeks following the consultation (5 point Likert scale: 5 = strongly agree that my decision was consistent with my personal values)

Clinician satisfaction with the consent consultation: staff emailed


NotesAim: to test a decision support intervention for uterine fibroid interventions

Conclusion: intervention participants were more aware of treatment options felt more informed and had more knowledge about fibroids and were more satisfied Clinicians were less satisfied with the intervention


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskBlock randomised of population size of clinics, first 2 large centres sorted into opposite arms

Nurses decided who should be enrolled based on whether they had made up their mind on treatment or not

Allocation concealment (selection bias)Low riskCentral randomisation

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskInsufficient detail in report, emailed authors

Response from authors: surveys were completed by patients and returned by mail to a data collection centre which optically scanned surveys. Since there was no manual entry of surveys, there was no opportunity for the scanning operator to adjust data based on study arm.  The completed data file was provided to the study statistician, who collated and summarized the data. The statistician was aware of group assignment for the purposes of data analysis

Tait 2009

MethodsRCT. Subjects interviewed at baseline, prior to intervention to ascertain baseline knowledge. They were then interviewed after catheterization and again around two weeks later, to assess understanding and satisfaction with the information received. Responses to questions were transcribed verbatim and scored at a later time independently by two assessors who were blinded to the groups assignments. Guidelines for scoring were determined a priori to give a score out of 12. The scoring system was based on the Deaconess Informed Consent Comprehension Test and has been described previously


Participants155 eligible consecutive adult patients. Aged over 18 yrs, scheduled for elective diagnostic cardiac catheterization. 13 were excluded and 7 were lost to follow up or withdrew, 71 were randomised to intervention, 71 to control. 135 were included in the analysis, with 66 in the control group and 69 in the intervention group

Patients that had undergone a catheterization within the past 3 years and those undergoing emergency catheterization were excluded

13 participants declined participation and 7 were lost due to withdrawal or incomplete data

Michigan, USA

Numbers of participants in analysis: 135

Intervention: 69

Control: 66


InterventionsInteractive computer programme using 2D & 3D graphics. 5th author is president and chief medical officer of the company who designed the intervention

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent and used a checklist

Done with clinician?: distant without clinician

Intervention type: interactive multimedia

Time of delivery: on admission


OutcomesImmediate knowledge: 24 hours post procedure

Short-term knowledge: around 2 weeks

Satisfaction with the consent process: overall satisfaction with perceptions of the message delivery were recorded using a ten point scale, 24 hours post procedure


NotesAim: evaluation of whether an interactive computer based information program for cardiac catheterization would result in improved patient understanding compared with standard verbal and written information

Conclusion: subjects who received information about cardiac catheterization using the intervention demonstrated significantly greater improvement in overall early understanding from baseline than those receiving standard information

Author contacted: yes, further information available for assessment of risk of bias


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number table

Allocation concealment (selection bias)High riskInsufficient detail in report, emailed authors. Author replied and stated that they "did not use any specific concealment technique such as sealed envelopes"

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Response from email regarding personnel: "On any given day the authors had no knowledge of which patient was randomised to which group, and had no knowledge of data collection"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPersonnel who transcribed interviews and scored understanding were blinded to patient allocation. Response from email: "All data was collected by research assistants with no vested interest in the study. At the end of the study, measures of understanding were scored independently by two of the authors who were blinded to the allocation of subjects to the control or intervention groups"

Thomas 2000

MethodsWell-designed RCT of videotape information versus usual discussion for chemo/radiotherapy after initial consultation recommending the procedure


Participants235 of whom 220 patients were randomised and analysed (113 to intervention and 107 to control). Inclusion = recommended by the clinician for either chemotherapy or radiotherapy with a diagnosis of cancer (breast, bowel, lymphoma or other)

UK

Numbers of participants in analysis: 135

Intervention: 69

Control: 66


InterventionsPost-consultation provided with a high-quality professionally-made 20 minute video consisting of comprehensive description of therapy, associated risks and patients describing their own experiences. Presented by Sue Lawley and Anton Rodgers. Participants took video home to watch after the initial consultation with clinician

Control group: involved same initial consultation and everyone given routine written information booklets (BACUP - British Association of Cancer United Patients)

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: multiple exposures of same intervention

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: non-interactive audiovisual

Time of delivery: before admission


OutcomesSatisfaction with consent process: assessed on 5-point scale, not validated but used in a previous audit and published before

Statistics note for 'satisfaction with consent process' - report gives frequency of responses for each point on a 5-point Likert scale. Data dichotomised by review team into (very satisfied + satisfied) = satisfied and (equivocal, unsatisfied and very unsatisfied) = dissatisfied for each group. The 'Unknown category' was excluded. Data entered for proportion in each group that had 'satisfied' responses

Generalised anxiety: HAD scores for depression and anxiety - using scores for anxiety only at present, reversed scores for entry into data tables since lower anxiety score is an improvement in outcome (total score = 21)

Outcomes measured 3 weeks into treatment (3 weeks after intervention)


NotesAim: to assess the benefits of receiving a cassette to take home following patients' first consultation

Conclusion: improved satisfaction and reduced treatment-related anxiety and depression


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskGenerated independently at trial centre: 240 randomisation cards written, 120 for control and intervention each. Cards placed in sealed opaque envelopes which were shuffled and placed in tight-fitting trial boxes. Order of envelopes remained the same and batches of 20 were sent to lead trial nurses at each Unit for opening at a time after written consent

Allocation concealment (selection bias)Low riskOpaque sealed envelopes

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up. 100% follow-up except for 'minor details' omitted on follow-up from 12 patients

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail. Data analysed centrally, but unclear whether outcome assessors blinded to allocation

Uzbeck 2009

MethodsRCT looking at more detailed written risk information versus briefer written risk information anxiety and satisfaction for bronchoscopy


Participants142 eligible patients for elective day-case bronchoscopy, of which 122 randomised and used in analysis in one centre

Galway, Ireland

Numbers of participants in analysis: 120

Intervention: 60

Control: 60


InterventionsWritten pages of risk information from 'Queensland Health consent form' providing basis for more detailed form before consent versus 'control group' of risk information from 'Addenbrooke's Hospital consent form'. Given in the day case suite and patients could read for 30-40 minutes before post-intervention evaluation completed. Then all patients discussed with doctor and consent taken

Intervention development: modified from standardised information

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and special leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesGeneralised anxiety: measured using VAS scale and modified APAIS (Amsterdam pre-op anxiety and information scale) pre- and post-intervention. Immediate assessment after intervention

Satisfaction with consent process: measured by four questions on 5-point scale made for the study


NotesAim: to determine the effect of more detailed risk disclosure on anxiety and satisfaction

Conclusion: provision of more detailed risk information before bronchoscopy may come at the cost of a small but significant increase in anxiety.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskGenerated by random placement of thoroughly shuffled marked cards into sequentially numbered, sealed, opaque envelopes by staff not involved in the rest of the trial

Allocation concealment (selection bias)Low riskSealed, opaque envelopes

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%; only 3 participants lost to follow-up (total 122)

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail; if aware of which arm of trial randomised to, would impact on outcome assessment. However, since both groups given an information leaflet this may not have occurred

Wadey 1997

MethodsRCT comparing effectiveness of standard consent process versus standard with repeat-back for patients undergoing ACL reconstruction. Outcome-knowledge was tested by questionnaire one month later, 3 question questionnaire


Participants20 patients from referral-based, outpatient, sport medicine clinic, referred for reconstruction of ACL-deficient knee

Calgary, Canada

Numbers of participants in analysis: 20

Intervention: 8

Control: 12


InterventionsStandard surgical consultation with 3 steps: 1. surgeon drawing diagram of knee. 2. surgeon explaining deficiency of ACL using 3D model. 3. Patient had the opportunity to hold and manipulate the model. Following this, intervention group were required to accurately verbalize the associated benefits and risks of the procedure back to the surgeon in their own words. Any errors were corrected until verbalization was accurate

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: all delivered by key research

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: face-to-face

Intervention type: structured consent

Time of delivery: before admission


OutcomesLong-term knowledge: one month later


NotesAim: to determine if preoperative patient verbalization of the risks and benefits of anterior cruciate ligament reconstruction enhances understanding of the risks and benefits of that procedure.

Conclusion: patients who verbalized the risks and benefits during their surgical consultation demonstrated a significantly greater understanding of the risks and benefits of an ACL reconstruction repair


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail. States 'randomly assigned'

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail. Unclear whether author who measured outcome was blinded or not to the groups' allocation

Walker 2007

MethodsRCT-single centre. Patients were randomised to receive a flip chart intervention as part of the informed consent consultation or not. All patients received a standard informed consent discussion delivered by the radiologists as part of routine care. Outcome measurements were a mixture of objective and subjective topics and therefore were selected according to protocol guidelines


Participants122 patients (inc in analysis) aged over 18 years who were referred for an image-guided core biopsy (stereotactic or US-guided) between February and October 2003. Patients were comparable at baseline, according to age, ethnicity and education level

USA

Numbers of participants in analysis: 122

Intervention: 63

Control: 59


Interventions47 page flip chart. Containing artwork with photos and line drawings. Key topics covered: breast anatomy, common breast abnormalities, diagnostic procedures, treatment, reconstruction and clinical trials. Addressed voluntarism, disclosure and understanding elements of the informed consent process. The chart presented information at an introductory level, including colourful graphics, designed to be culturally sensitive and suitable for high and low grade literacy patients and their families

Participants in the control group received a standard informed consent discussion delivered by the radiologists in practice at the breast health centre

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: face-to-face

Intervention type: structured consent

Time of delivery: on admission


OutcomesImmediate knowledge: post informed consent discussion, no information on questionnaire

Satisfaction with consent process: Likert scale-not validated

Anxiety with consent process: STAI

Self-reported understanding: decision was taken to report the information post consultation as this was nearer to the consent procedure as opposed to the information gained from follow up

Desire for further information: no raw data for this outcome.


NotesAim: to examine the effect of an educational intervention used during the informed consent discussion for women referred for breast biopsy

Conclusion: the usual care consent process is effective for many but not all patients. Informed consent that employs visual aids may help overcome characteristics of the consent process that are ineffective for some patients


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generates sequence, random in equal proportions

Allocation concealment (selection bias)Unclear riskInsufficient detail; email from author stated that they used sealed, consecutive envelopes, no details as to whether these were opaque or not

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskEmail from author stated that the researchers were not blinded to the patient allocations

Whelan 2003

MethodsMulticentre RCT in USA comparing decision boards with usual care in making decisions to have chemotherapy as adjuvant to breast cancer treatment


Participants176 participants were randomised, 1 was then excluded. Total 175 in analysis: 82 in control and 93 in intervention. Patients were women with breast cancer who had been identified by clinician after primary surgery to be suitable for adjuvant chemotherapy. Similar demographics and baseline characteristics. Recruitment occurred between October 1995 and March 2000

Numbers of participants in analysis: 176

Intervention: 83

Control: 93


InterventionsBoth groups had initial meeting with clinician to discuss treatment options in 'usual fashion'

Intervention group then met with a nurse who introduced and explained the intervention (decision board). Patients encouraged to ask question during and after the presentation. Given a copy to take home

Control group: met with nurse after discussion as well (which was usual care) and encouraged to ask any questions. After meeting with the primary care nurse patients in both groups received the same lymph-node negative breast cancer pamphlet. Patients were asked to return one week later to see the medical oncologist who would then answer any further questions regarding the consultation or materials received and to make a decision regarding treatment.

The Decision Board "contains detailed information tailored to the individual on a patient’s treatment choices (chemotherapy or no chemotherapy); outcomes (recurrence or not); probability of outcomes and their meaning; and quality of life associated with treatment choice and outcome. … The treatment choices and outcomes are described by detailed information cards, and the probabilities of recurrence are described by colour-coded probability wheels. Probabilities for recurrence with or without chemotherapy are tailored to the patient’s risk on the basis of tumour size and histologic tumour grade.” Format: "Empty initially, the patient and nurse read each information card and then attach it to the board."

This aid has been developed to a high quality and used in previous publications by this research group (see Levine et al., 1992 - ref in paper)

Intervention development: designed for trial with reasonable effort for validation/piloting

Exposure: multiple exposures of same intervention

Training for delivery of intervention: structured/extensive training

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: face-to-face

Intervention type: multiple interventions including decision aid

Time of delivery: before admission


OutcomesShort-term knowledge: 25 item questionnaire, validated, covers natural history of breast cancer, risk of recurrence, what chemo is and how given, benefits and risks of chemotherapy. Assessed at one week post-intervention. Each question had true/false/unsure responses. Scored on percentage correct (total 100%)

Satisfaction with decision making: 4-item questionnaire (effective decision-making subscale of Decisional Conflict Scale (DCS)), validated. Assessed at 1 week, 3, 6 and 12 months after intervention. Mean score obtained per person, they then reversed scores so 5 = strongly agree. Data extracted from graphical presentation in paper

Generalised anxiety: assessed by STAI at 1 week, then at 3, 6, 12 months'

Sense of control: asked if were offered a choice to have chemotherapy. Not validated

Uptake rates: numbers deciding to have chemotherapy as expressed by patient

Clinician satisfaction with decision making: modified form of questionnaire given to patients for satisfaction (from DCS). Mean scores given. Completed immediately after initial consultation

Length of consultation: total taken for duration of first consultation and follow-up after the intervention


NotesAim: to determine whether adding the Decision Board to the medical consultation improved patient knowledge and satisfaction compared with the medical consultation alone

Conclusion: when making decisions regarding adjuvant chemotherapy, patients with early breast cancer who had been exposed to the Decision Board had better knowledge of the disease and treatment options and greater satisfaction with their decision making than those who received the standard consultation


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient detail: patients were stratified by medical oncologist/primary care nurse team before randomisation. No details on methods of randomisation

Allocation concealment (selection bias)Low riskCentral allocation

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%. Low attrition rates: only 1 patient lost to follow-up in short-term analysis. For long term follow-up: 78/92 control group followed-up at 12 months’ and 72/81 = 13% attrition rate over 1 year

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail. No information on who the outcome assessors were or whether blinded

Wilhelm 2009

MethodsRCT, patients shown a DVD one week prior to surgery, data collected in outpatients one week after discharge


ParticipantsPatients undergoing laparoscopic cholecystectomy between May 2005 and May 2007 (259 recruited and 212 completed)

USA

Numbers of participants in analysis: 212

Intervention: 114

Control: 98


InterventionsDVD with 5 parts, 26 minutes, based on discussion with surgeon and actor patient with the use of written text and picture information and complex 3D computer animation

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: no details

Control characteristics: verbal consent

Done with clinician?: distant without clinician

Intervention type: non-interactive audio-visual

Time of delivery: before admission


OutcomesShort-term knowledge: knowledge at 1 week post op - knowledge test score out of 30

Satisfaction with the consent process: 1 week post op - satisfaction score out of 5


NotesAims: to evaluate the impact of an extended education in the form of a DVD on patients understanding of cholecystectomy

Conclusions: extended education using additional tools such as multimedia DVD has a significant impact on post-operative patient knowledge and improves the quality of informed consent

Author contacted: details on risk of bias and standard deviations gained for short-term knowledge and satisfaction with the consent process


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskReport quotes 'using a specifically designed randomisation list'. Author confirms this in email, using a die

Allocation concealment (selection bias)Unclear riskInsufficient detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%; 81.8% completed questionnaires

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasHigh riskPatient groups not comparable at baseline with respect to education level, intervention group had higher education status

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Wong 2006

MethodsRCT looking at effect of a decisional-aid booklet on choice of termination method, measures of effective decision making (including risk perception, attitudes and knowledge of both the medical and surgical methods), decisional conflict, anxiety and usefulness of the leaflet


Participants1177 patients were approached, of which 326 were randomised to receive either intervention or control. These were patients visiting the Unit for 'Fertility Control' for pregnancy termination (under 9 weeks of gestation) presenting for a decision-discussion with a clinician and then booking to return in a fortnight for the procedure. Participants were comparable at baseline, age, marital status, education level, ethnicity, prior obstetric history were recorded

Leeds, United Kingdom

Numbers of participants in analysis: 191

Intervention: 103

Control: 88


InterventionsDecisional-aid leaflet with previous validation and piloting - of good quality. The booklet was produced by the research team which had been previously piloted and based on evidence on EBM. (references given) Given out in the waiting room before discussion with the clinician. Control group given a leaflet on contraception so everyone seen to be reading

Intervention development: designed for trial with reasonable efforts for validation/piloting

Exposure: once

Training for delivery of intervention: none needed

Evaluation of the delivery of intervention: evidence of fidelity/reliability of delivery

Control characteristics: verbal consent and dummy intervention

Done with clinician?: face-to-face

Intervention type: decision aid

Time of delivery: before admission


OutcomesRates of uptake: postponement of clinical interventions - from clinic data

Statistics note on rates of uptake: taking medical or surgical termination to both be invasive procedures in this review, and contrasting to rates of refusal (continuing with pregnancy, not going through with termination). Focus on rate of uptake of invasive procedures requiring consent rather than refusal

Satisfaction with decision making: measured by effective sub-scale of 'decisional conflict' tool in DCS questionnaire - previously validated and reliability-checked

Immediate knowledge: scale score, no information on what tested, questionnaire assessment

Anxiety with decision making: from modified STAI, previously validated in modified form


NotesAim: to evaluate the effectiveness of a decision aid to help women choose between surgical and medical methods of pregnancy termination.

 “Specifically, the study investigated the impact of the decision aid to:

  • Increase the number of medical terminations
  • Improve women’s experience of choosing between medical and surgical termination methods
  • Change cognitions associated with the employment of more effective decision-making strategies at the time of decision making and immediately after having the procedure


Increase the perceived usefulness of written information provided by the termination services”

Conclusion: “A simple decision-aid leaflet read before a routine consultation enables women to make better and more informed choices about which method of pregnancy termination to have.

In addition, as the intervention had a sustained effect on women’s views, it is feasible that a longer term impact may be observed on women’s subsequent use of termination services"


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskShuffling cards or envelopes, drawing of lots

Allocation concealment (selection bias)Low riskSequentially numbered, opaque sealed envelopes

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%. Note - not used intention to treat analysis, but equal loss to follow-up in each group and unlikely to bias outcome

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail. Dummy intervention used in control group, but unclear if clinicians blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote from report: “to minimise bias in this real-world setting, study identifiers were only referred to at the end of the recruitment phase during data entry by SSMW”

Yucel 2005

MethodsMulticentre-RCT. Patients received either an informed consent form or a more detailed informed consent form

STAI measured by questionnaire prior to intervention. Trait anxiety was repeated after the intervention


Participants265 eligible patients, 74 of whom were excluded. Remaining 191 were randomised: 103 to intervention, 88 to control. Patients referred between Nov 2003 and march 2004 for CT or excretory urography requiring IV contrast material. Must have graduated from primary school

Turkey

Numbers of participants in analysis: 191

Intervention: 103

Control: 88


InterventionsControl group had a consent form with brief information including only the most common risks and risk factors associated with IVCM. The intervention group had more comprehensive information

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: no details

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: on admission


OutcomesAnxiety with consent process: authors measured state and trait anxiety prior to the consent process, and again after the intervention. We have taken trait anxiety after intervention as our outcome measure because trait anxiety measures how the patients feel in that particular situation or moment whereas state anxiety evaluates how the patient feels independently of this situation or condition at that moment

The authors also asked patients if they desired to be informed about intra venous contrast material prior to the consent procedure. Authors note that informed consent is not usually obtained in Turkey. This outcome was not included in our study because it did not meet the criteria of desire for further information


NotesAim: to compare the effect of two different consent forms on patients; anxiety level prior to intravenous contrast material injection

Conclusion: informed consent including general information about the risk factors and potential adverse reactions of IV contrast material reduced anxiety level, but detailed informed consent increased anxiety level before the procedure


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskDivided according to file number, odd or even number. Uncertain about how patients were selected, states 'cooperative' patients

Allocation concealment (selection bias)High riskClear by the file number which group they were allocated to

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient detail

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskNo identified areas of concern

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail

Zite 2011

MethodsTwo armed RCT comparing a low literacy level information sheet/consent form to the standard, higher reading age form currently used. Patients were randomised and shown form, then knowledge was assessed immediately


ParticipantsBetween May and July 2010, 210 participants who were undergoing tubal sterilisation were eligible, of whom 201 completed and were analysed

USA

Numbers of participants in analysis: 201

Intervention: 102

Control: 99


InterventionsA low-literacy version of the Medicaid-Title XIX SCF, written at the 6th grade reading level compared to the standard "Medicaid-Title XIX SCF" which is a one page document, currently used  throughout the United States and written at a high school reading level

Intervention development: designed for trial with no validation

Exposure: once

Training for delivery of intervention: all delivered by key researcher

Evaluation of the delivery of intervention: no details

Control characteristics: verbal and standardised leaflet

Done with clinician?: distant without clinician

Intervention type: written

Time of delivery: before admission


OutcomesImmediate knowledge: assessed immediately via five closed-ended questions, addressing content outlined on both the standard and  the low-literacy Medicaid-Title XIX SCF, to assess sterilization-related knowledge. An overall sterilization-related knowledge composite was calculated based on participants’ total number of correct responses to these five close-ended items. Participants were categorized as having limited (zero to three correct responses) or adequate (four or more correct responses) sterilization-related knowledge

Women’s preferences for either the standard or the low-literacy Medicaid-Title XIX SCF


NotesAim: To estimate whether Medicaid-Title XIX SCF format “standard” compared with “low literacy” was associated with women’s understanding  of tubal sterilization

Conclusion: The study's results support replacing the standard Medicaid-Title XIX SCF with the low-literacy version to foster increased understanding of sterilization


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated sequence with permuted blocks of 10

Allocation concealment (selection bias)Low riskAssignment was concealed by placing a photocopy of either the standard or the low-literacy Medicaid-Title XIX SCF into a beige manila file folder. The research assistant always opened the next manila file folder in the pre-randomised stack, which allocated participants to one of the two study groups in accordance with the randomisation sequence

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition less than 40%. 1% loss to follow up

Selective reporting (reporting bias)Unclear riskNo protocol found

Other biasLow riskParticipants were paid $10 to compensate their time, but unlikely to affect outcome

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskKnowledge assessment not blinded and performed by research assistant. Coding of responses regarding preference of forms was blinded

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Ader 1992No control group within the randomised arms of trial. Comparing interactive with non-interactive video of same material, but no usable data for the review

Altaie 2011No usable data,  Table 4

Broyles 1992Looking at an intervention for a procedure (neonatal mechanical ventilation) which does not require informed consent

Clark 2011No usable data,  Table 4

Dawes 1992Control group not randomised. Randomisation happened between two interventions, therefore no comparable data for this review

Dawes 1993Study examining the patients' attitudes towards informed consent. No outcomes relevant to our review. Same data set as Dawes 1992

Eggers 2007Not an RCT - no randomisation performed

Finch 2009No usable data,  Table 4

Fink 2010aSame data as Fink 2010 but no outcomes relevant to our review

Graham 2000Not targeting consent – instead targeting all pregnant women to improve knowledge about prenatal testing

Grawe 2010Impact of general education (not on consent or decision making) on pain

Gyomber 2010No usable data,  Table 4

Hewison 2001Not about consent for invasive procedure, but information for all pregnant women about prenatal testing

Hilzenrat 2006Anxiety for liver biopsy, not targeting consent or decision making process

Jlala 2010Anxiety for surgery, not targeting consent or decision making process

Johnson 2011No control group - comparator group has usual consent and customised written handout

Kasper 2008Immunotherapy - not invasive healthcare procedure

Lembcke 1998Three leaflets as three intervention arms in trial, no control group. Unable to differentiate between leaflets as individual leaflets not accessible

Lipp 1991Not an RCT

Migden 2008No usable data,  Table 4

Nagle 2008Information given to all pregnant women to improve their knowledge of prenatal testing – not targeted at women having an intervention that requires consent

O'Cathain 2002Detailed information around areas of pregnancy and childbirth but no specific healthcare procedure addressed

Roth-Isigkeit 2001aNot invasive healthcare procedure

Scanlan 2003No usable data,  Table 4

Schenker 2010Editorial discussing paper by Tait 2009

Shurnas 2003Only difference in the two groups was that one group signed the list of risks that a surgeon used as a prompt during consultation whereas the other group did not sign it. Neither group had any longer exposure to the list or any use of the list. Consensus opinion of the review authors that signing the form not an intervention that directly aims to improve informed consent

Stanley 1998No usable data,  Table 4

Steckelberg 2011Interventions to improve screening uptake, but not looking at interventions to help choose between screening methods

Taylor 2010Randomisation collapsed before analysis of results

Wright 2010Anxiety for procedure, not about consent or decision making

 
Comparison 1. All studies: Interventions that promote informed consent

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Informed consent: continuous data1Mean Difference (IV, Random, 95% CI)Totals not selected

 2 Patient understanding: continuous data2Mean Difference (IV, Random, 95% CI)Totals not selected

 3 Patient self-report of understanding: continuous data2Std. Mean Difference (IV, Random, 95% CI)Totals not selected

 4 Patient self-report of understanding: dichotomous data1Risk Ratio (M-H, Random, 95% CI)Totals not selected

 5 Knowledge/retention/recall - immediate: continuous data262852Std. Mean Difference (IV, Random, 95% CI)0.53 [0.37, 0.69]

 6 Knowledge/retention/recall - short term: continuous data162106Std. Mean Difference (IV, Random, 95% CI)0.68 [0.42, 0.93]

 7 Knowledge/retention/recall - long term: continuous data171353Std. Mean Difference (IV, Random, 95% CI)0.78 [0.50, 1.06]

 8 Knowledge/retention/recall - immediate: dichotomous data3331Risk Ratio (M-H, Random, 95% CI)1.17 [0.85, 1.60]

 9 Knowledge/retention/recall - short term: dichotomous data2Risk Ratio (M-H, Random, 95% CI)Totals not selected

 10 Knowledge/retention/recall - long term: dichotomous data2Risk Ratio (M-H, Random, 95% CI)Totals not selected

 11 Knowledge/retention/recall: non-parametric dataOther dataNo numeric data

    11.1 Immediate knowledge
Other dataNo numeric data

    11.2 Short-term knowledge
Other dataNo numeric data

    11.3 Long-term knowledge
Other dataNo numeric data

 12 Deliberation: continuous data1Mean Difference (IV, Random, 95% CI)Totals not selected

 13 Decisional conflict: continuous data3837Std. Mean Difference (IV, Random, 95% CI)-1.80 [-3.46, -0.14]

 14 General or procedural-related anxiety: continuous data142069Std. Mean Difference (IV, Random, 95% CI)-0.11 [-0.35, 0.13]

 15 General or procedure-related anxiety: dichotomous data2Risk Ratio (M-H, Random, 95% CI)Totals not selected

 16 Anxiety (or other psychological stress) with consent process: continuous data131407Std. Mean Difference (IV, Random, 95% CI)0.01 [-0.21, 0.23]

 17 Anxiety (or other psychological stress) with consent process: dichotomous data1Risk Ratio (M-H, Random, 95% CI)Totals not selected

 18 Anxiety (or other psychological stress) with consent process: non-parametric dataOther dataNo numeric data

 19 Anxiety (or other psychological stress) with decision-making: continuous data1Mean Difference (IV, Random, 95% CI)Totals not selected

 20 Satisfaction with consent process: continuous data152024Std. Mean Difference (IV, Random, 95% CI)0.12 [-0.09, 0.32]

 21 Satisfaction with consent process: dichotomous data101045Risk Ratio (M-H, Random, 95% CI)1.04 [0.97, 1.12]

 22 Satisfaction with consent process: non-parametric dataOther dataNo numeric data

 23 Satisfaction with decision making: continuous data82144Std. Mean Difference (IV, Random, 95% CI)2.25 [1.36, 3.15]

 24 Satisfaction with decision making: dichotomous data1Risk Ratio (M-H, Random, 95% CI)Totals not selected

 25 Pain levels: continuous data2Std. Mean Difference (IV, Random, 95% CI)Totals not selected

 26 Pain levels: dichotomous data2Risk Ratio (M-H, Random, 95% CI)Totals not selected

 27 Analgesia use: non-parametric dataOther dataNo numeric data

 28 Desire for further information: dichotomous data4849Risk Ratio (M-H, Random, 95% CI)0.65 [0.35, 1.22]

 29 Sense of control - locus of control or perception of who made the decision: continuous data1Mean Difference (IV, Random, 95% CI)Totals not selected

 30 Sense of control - locus of control or perception of who made the decision: dichotomous data3971Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.98, 1.09]

 31 Clinician outcome: satisfaction with the consent consultation: continuous data1Mean Difference (IV, Random, 95% CI)Totals not selected

 32 Clinician outcome: satisfaction with the consent consultation: dichotomous data1Risk Ratio (M-H, Random, 95% CI)Totals not selected

 33 Systems outcome: rates of uptake (or refusal) of clinical interventions/procedures: dichotomous data103075Risk Ratio (M-H, Random, 95% CI)0.98 [0.95, 1.02]

 34 Systems outcome: length of consultations: continuous data6517Mean Difference (IV, Random, 95% CI)1.66 [0.82, 2.50]

 35 Systems outcome: economic-time taken to consent: non-parametric dataOther dataNo numeric data

 
Analysis 1.11 Comparison 1 All studies: Interventions that promote informed consent, Outcome 11 Knowledge/retention/recall: non-parametric data.
Knowledge/retention/recall: non-parametric data

StudyOutcomeTiming of outcomeIntervention group medianIntervention group IQRIntervention NControl group medianControl group IQRControl NP value

Immediate knowledge

Astley 2008aRecall - score out of 12Immediate43-5343.52-516

Astley 2008bRecall - score out of 12Immediate43-6333.52-516

Lavelle-Jones 1993Recall - score out of 6Immediately after consent42-612642-6127P = 0.68

Mason 2003Recall - score out of 20Immediately after1816-181511.5010-1516P < 0.001

Short-term knowledge

Lavelle-Jones 1993Recall - score out of 6On day of discharge (median = day 5, range = 1-9242-612131-61210.015

Long-term knowledge

Astley 2008aRecall - score out of 1230 days21-33431-416

Astley 2008bRecall - score out of 1230 days32-43331-416

Gerancher 2000recall - score out of 1005-7 months after9080-100448070-9038p<0.001

Greening 1999Recall1-7 days after full course of ECT. Large range in ECT treatment course length81-121040-1214

Lavelle-Jones 1993Recall - score out of 6Outpatients clinic at 4-6 weeks following discharge32-611231-6111P = 0.55

Wadey 1997recall-score out of 31 month33-3822-312

 
Analysis 1.18 Comparison 1 All studies: Interventions that promote informed consent, Outcome 18 Anxiety (or other psychological stress) with consent process: non-parametric data.
Anxiety (or other psychological stress) with consent process: non-parametric data

StudyOutcomeTiming of AssessmentIntervention Group MedianIntervention Group IQRIntervention Group NControl Group MedianControl Group IQRControl Group NNotes

Astley 2008a5 point anxiety scale with 5=anxiousImmediate32-43432-416

Astley 2008b5 point anxiety scale with 5=anxiousImmediate32-43332-416

Mason 20036 Item version of Speilberger State Anxiety InventoryImmediately after intervention9.06-1515106-1516P = N.S.

 
Analysis 1.22 Comparison 1 All studies: Interventions that promote informed consent, Outcome 22 Satisfaction with consent process: non-parametric data.
Satisfaction with consent process: non-parametric data

StudyOutcomeTiming of AssessmentIntervention group medianIntervention Group IQRIntervention Group NControl Group medianControl Group IQRControl group NNotes

Astley 2008aSatisfaction with the consent processImmediate44-53454-516

Astley 2008bSatisfaction with the consent processImmediate44-53354-516

Neary 2010SatisfactionPost-op2826-30312825.3-3020P = 0.976

 
Analysis 1.27 Comparison 1 All studies: Interventions that promote informed consent, Outcome 27 Analgesia use: non-parametric data.
Analgesia use: non-parametric data

StudyOutcomeTimingIntervention Group: MedianIntervention Group: IQRIntervention Group: NControl Group: MedianControl Group: IQRControl Group: NNotes

Neary 2010Analgesia Requirement (WHO)24 hours11-23111-220P = 0.769

 
Analysis 1.35 Comparison 1 All studies: Interventions that promote informed consent, Outcome 35 Systems outcome: economic-time taken to consent: non-parametric data.
Systems outcome: economic-time taken to consent: non-parametric data

StudyIntervention: median

(mins)
IQR

(mins)
NControl: median

(mins)
IQR

(mins)
N

Fink 201011.927.2-152518.004-11.89258

 
Comparison 2. Interventions that promote informed consent: Face-to-face interventions and distant interventions

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Distant interventions: knowledge/retention/recall - immediate161175Std. Mean Difference (IV, Random, 95% CI)0.53 [0.32, 0.75]

 2 Distant interventions: knowledge/retention/recall - short term131279Std. Mean Difference (IV, Random, 95% CI)0.79 [0.44, 1.14]

 3 Distant interventions: anxiety (or other psychological stress) with consent process10642Std. Mean Difference (IV, Random, 95% CI)0.05 [-0.22, 0.32]

 4 Distant interventions: systems outcome: length of consultations3256Mean Difference (IV, Random, 95% CI)1.22 [0.23, 2.22]

 5 Face to face interventions: knowledge/retention/recall - immediate101677Std. Mean Difference (IV, Random, 95% CI)0.52 [0.28, 0.76]

 6 Face to face interventions: knowledge/retention/recall - short term3827Std. Mean Difference (IV, Random, 95% CI)0.35 [0.12, 0.59]

 7 Face to face interventions: anxiety (or other psychological stress) with consent process3765Std. Mean Difference (IV, Random, 95% CI)-0.08 [-0.41, 0.25]

 8 Face to face interventions: systems outcome: length of consultations3261Mean Difference (IV, Random, 95% CI)2.81 [1.07, 4.55]

 
Comparison 3. Interventions to promote informed consent: consent on behalf of a minor and self consent

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Consent on behalf of a minor: knowledge/retention/recall - immediate3123Std. Mean Difference (IV, Random, 95% CI)0.55 [0.15, 0.96]

 2 Consent on behalf of a minor: anxiety (or other psychological stress) with consent process3212Std. Mean Difference (IV, Random, 95% CI)0.14 [-0.30, 0.57]

 3 Self-consent: knowledge/retention/recall - immediate232729Std. Mean Difference (IV, Random, 95% CI)0.52 [0.36, 0.69]

 4 Self-consent: anxiety (or other psychological stress) with consent process101195Std. Mean Difference (IV, Random, 95% CI)-0.02 [-0.28, 0.23]

 
Comparison 4. Interventions that promote informed consent : Classification of interventions

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Written: knowledge/retention/recall - immediate6236Std. Mean Difference (IV, Random, 95% CI)0.29 [-0.17, 0.75]

 2 Written: knowledge/retention/recall - short term6265Std. Mean Difference (IV, Random, 95% CI)0.99 [0.33, 1.64]

 3 Written: knowledge/retention/recall - long term8638Std. Mean Difference (IV, Random, 95% CI)0.47 [0.21, 0.73]

 4 Written: general or procedural-related anxiety3729Std. Mean Difference (IV, Random, 95% CI)0.36 [-0.17, 0.89]

 5 Written: anxiety (or other psychological stress) with consent process6383Std. Mean Difference (IV, Random, 95% CI)0.02 [-0.38, 0.43]

 6 Written: satisfaction with consent process6821Std. Mean Difference (IV, Random, 95% CI)0.19 [-0.29, 0.67]

 7 Audiovisual: knowledge/retention/recall - immediate8644Std. Mean Difference (IV, Random, 95% CI)0.72 [0.40, 1.04]

 8 Audiovisual: knowledge/retention/recall - short term4697Std. Mean Difference (IV, Random, 95% CI)0.73 [0.14, 1.32]

 9 Audiovisual: general or procedural-related anxiety5444Std. Mean Difference (IV, Random, 95% CI)-0.48 [-1.07, 0.12]

 10 Audiovisual: anxiety (or other psychological stress) with consent process4259Std. Mean Difference (IV, Random, 95% CI)0.08 [-0.32, 0.47]

 11 Audiovisual: satisfaction with consent process4627Std. Mean Difference (IV, Random, 95% CI)0.05 [-0.11, 0.21]

 12 Audiovisual: satisfaction with consent process (dichotomous)4502Risk Ratio (M-H, Random, 95% CI)1.10 [0.91, 1.34]

 13 Interactive multimedia: knowledge/retention/recall - short term3317Std. Mean Difference (IV, Random, 95% CI)0.47 [0.16, 0.77]

 14 Interactive multimedia: satisfaction with consent process3348Std. Mean Difference (IV, Random, 95% CI)0.23 [-0.46, 0.92]

 15 Structured: knowledge/retention/recall - immediate5844Std. Mean Difference (IV, Random, 95% CI)0.43 [0.16, 0.70]

 16 Decision aid: knowledge/retention/recall - immediate4673Std. Mean Difference (IV, Random, 95% CI)0.64 [0.26, 1.02]

 17 Decision aid: knowledge/retention/recall - short term3827Std. Mean Difference (IV, Random, 95% CI)0.35 [0.12, 0.59]

 18 Decision aids: satisfaction with decision making71605Std. Mean Difference (IV, Random, 95% CI)2.64 [1.50, 3.77]

 
Comparison 5. Interventions that promote informed consent: Timing of intervention

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Before admission: knowledge/retention/recall - immediate101383Std. Mean Difference (IV, Random, 95% CI)0.50 [0.16, 0.85]

 2 Before admission: anxiety (or other psychological stress) with consent process101064Std. Mean Difference (IV, Random, 95% CI)-0.12 [-0.33, 0.09]

 3 Before admission: satisfaction with consent process91352Std. Mean Difference (IV, Random, 95% CI)0.14 [-0.12, 0.41]

 4 Before admission: satisfaction with consent process (dichotomous)4460Risk Ratio (M-H, Random, 95% CI)1.12 [0.94, 1.33]

 5 After admission: knowledge/retention/recall - immediate151309Std. Mean Difference (IV, Random, 95% CI)0.55 [0.40, 0.70]

 6 After admission: anxiety (or other psychological stress) with consent process3343Std. Mean Difference (IV, Random, 95% CI)0.41 [0.19, 0.62]

 7 After admission: satisfaction with consent process6672Std. Mean Difference (IV, Random, 95% CI)0.10 [-0.26, 0.46]

 8 After admission: satisfaction with consent process (dichotomous)6585Risk Ratio (M-H, Random, 95% CI)1.00 [0.96, 1.04]

 
Table 1. Risk of bias: Rules applied when assessing the risk of bias

Risk of bias domainLow riskUnclear riskHigh risk

Random sequence generationClearly described and appropriate method of randomisation (e.g. computerised randomisation).No description of random sequence generation.Alternation or allocation by date or hospital number

Allocation concealmentClearly described and appropriate method of allocation concealment (e.g. central or pharmacy allocation).No description of allocation concealment.Inappropriate method of allocation concealment or evidence that allocation procedure was not adhered to.

Blinding of participants and personnelClearly described and appropriate method of blinding of BOTH participants and personnel.No description of blinding of participants and personnel.Inappropriate method of blinding, evidence that blinding procedure was not adhered to or study was ‘unblinded’ for EITHER participants or personnel.

Blinding of outcome assessorsClearly described and appropriate method of blinding of outcome assessors.No description of blinding of outcome assessors.Inappropriate method of blinding, evidence that blinding procedure was not adhered to or study was ‘unblinded’ for outcome assessors.

Incomplete outcome dataAttrition of participants of < 40%.No description of attrition.Attrition of participants of ≥ 40%.

Selective outcome reportingProtocol available and all outcomes pre-specified were reported in the final publication. No protocol available.Protocol available and one or more outcomes pre-specified were not reported in the final publication. 

Other sources of biasNo evidence of elements of high risk of bias.Not applied.Evidence of any of:

  1. Baseline incomparability not adjusted for in analysis
  2. Potential contamination of intervention
  3. Sources of funding leading to competing interests
  4. No ITT analysis

 
Table 2. Details of the development of the intervention, the exposure to the intervention, the training for delivery of the intervention and evaluation of the intervention delivery; 72 treatment arms reported here

Development of the intervention Number of intervention arms

no details6

designed for trial - no validation42

designed for trial - reasonable effort for validation/piloting16

modified from standard information4

standard information - no modifications4

 Total72

Exposure to the intervention

once65

twice1

multiple exposures to the same intervention4

two different interventions at different times2

 Total72

Training for delivery of intervention

none needed22

no details35

no training0

brief training9

structured/extensive training2

all delivered by key researcher4

 Total72

Evaluation of delivery of the intervention

no details59

evidence of fidelity/reliability of delivery13

 Total72

 
Table 3. Details of the consent process in the control group

Details of the consent process in the control group  Number of intervention arms

No details2

verbal only33

verbal + standardised leaflet20

verbal + special leaflet3

verbal + checklist12

verbal + dummy intervention1

audiovisual1

 Total72

 
Table 4. Studies with unusable or insufficient data for analysis

StudyDetails of studyDetails of data

Altaie 2011A three armed RCT looking at patients recall of knowledge.

36 patients undergoing strabismus surgery were randomised to either standardised consent, standardised plus written information or standardised plus written that included a quiz in the leaflet.

A questionnaire was administered on admission which asked the same questions as the quiz.
No numbers presented in the results.

Clark 2011RCT looking at patient recall of knowledge.

50 patients admitted for elective laparoscopic cholecystectomy in the USA were randomised to either a power point presentation or to usual care.

A questionnaire was completed after the power point (before surgery) to test knowledge.
Results show mean scores for the two groups but there is not enough detail to extract a SD.

Unable to contact authors

Finch 2009RCT looking at patient recall of knowledge.

100 patients admitted for a transurethral resection of prostate in the UK were randomised to either standard consent or a more detailed written form.

These forms were given the night before surgery and recall was tested with a questionnaire three hours later.
Data not presented in usable form for this review. Unable to make contact with author

Gyomber 2010RCT looking at patient recall of knowledge.

40 patients admitted for a radical prostatectomy in Australia were randomised to either standard consent or consent in an interactive multimedia form.

Recall was tested immediately after the intervention was given.
Medians and N values are the only data shown

Migden 2008RCT looking at patient recall of knowledge, satisfaction with the consent process and time of consultation.

11 patients under going Mohs surgery in the USA were randomised to either standard consent or consent with a video.

Satisfaction collected on a Likert scale and no details of how knowledge was tested.
Data not presented in usable form for this review.

Time given as a mean with no SD.

No data given on knowledge and satisfaction.

Contact with author - he is unable to give raw data

Scanlan 2003RCT looking at patients recall of knowledge .

28 patients undergoing cataract surgery in Canada were randomised to either receive or not to receive further written in formation after the consent consultation.

Knowledge was assessed by a questionnaire at time of consultation and one week after surgery.
Data not presented in usable form for this review. Unable to obtain raw data from authors

Stanley 1998A four armed RCT that looked at knowledge and anxiety with the consent process.

32 patients undergoing femoral popliteal bypass or carotid surgery in Australia were randomised into groups of normal consent, more detailed written consent, more detailed verbal consent and more detailed written and verbal consent.

HADS scores for anxiety and a questionnaire for knowledge were administered after the consent process.
No extractable data available.

 
Table 5. Overview of findings

InterventionNumber of studies (arms)Immediate knowledgeShort-term knowledgeLong-term knowledgeGeneralised anxietyAnxiety with the consent processDecisional conflictSatisfaction with the consent processSatisfaction with the decision making

All interventions65

(72 arms)
22 studies

(26 arms)

SMD 0.53

(0.37 to 0.69)

I2 = 73%
14 studies (16 arms)

SMD 0.68 (0.42 to 0.93)

I2 = 85%
15 studies

(17 arms)

SMD 0.78 (0.50 to 1.06)

I2 = 82%
 12 studies

(14 arms )

SMD -0.11

(-0.35 to 0.13)

I2 = 82%
11 studies

(13 arms )

SMD 0.01

(-0.21 to 0.23)

I2 = 70%
3 studies

(3 arms)

SMD -1.80

(-3.46 to -0.14)

I2 = 99%
 13 studies

(15 arms)

SMD 0.12

(-0.09 to 0.32)

I2 = 76%
8 studies

(8 arms)

SMD 2.25

(1.36 to 3.15)

I2 = 99%

All interventions

Dichotomous data
 3 studies

(3 arms)

RR1.17

(0.85 to 1.60)

I2 = 84%
No dataNo dataNo dataNo dataNo data10 studies

(10arms)

RR 1.04

(0.97 to 1.12)

I2 = 75%
No data

Face-to-face interventions16

(16 arms)
10 studies

(10 arms)

SDM 0.52

(0.28 to 0.76)

I2 = 80%
3 studies

(3 arms)

SMD 0.35

(0.12 to 0.59)

I2 = 55%
No dataNo data3 arms

(3 studies)

SMD -0.08

(-0.41 to 0.25)

I2 = 73%
No dataNo dataAs above in ‘all interventions’

Distant interventions51

(56 arms)
14 studies

(16 arms)

SDM 0.53

(0.32 to 0.75)

I2 = 67%
11 studies (13 arms)

SMD 0.79

(0.44 to 1.14)

I2 = 87%
Not analysedNot analysed8 studies

(10 arms)

SMD 0.05

(-0.22 to 0.32)

I2 = 58%
Not analysedNot analysed 

Consent on behalf of a minor5

(6 arms)
2 studies

(3 arms)

SMD 0.55

(0.15 to 0.96)

I2 = 13%
No dataNo dataNo data2 studies

(3 arms)

SMD 0.14

(-0.03 to 0.57)

I2 = 51%
No dataNo dataNo data

Self consent60

(66 arms)
20 studies

(23 arms)

SMD 0.52

(0.36 to 0.69)

I2= 75%
Not analysedNot analysedNot analysed 9 studies

(10 arms)

SMD -0.02

(0.28 to 0.23)

I2=72%
Not analysedNot analysedNot analysed

Written26

(27 arms)
6 studies

(6 arms)

SMD 0.29

(-0.17 to 0.75) I2 = 65%)
5 studies

(6 arms)

SMD 0.99 (0.33 to 1.64)

I2 = 80%
8 studies

(8 arms)

SMD 0.47 (0.21 to 0.73) I2 = 58%
3 studies

(3 arms)

SMD 0.36

(-0.17 to 0.89)

I2 = 83%
6 studies

(6 arms)

SMD 0.02

(-0.38 to 0.43) I2 = 67%
No data5 studies

(6 arms)

SMD 0.19

(-0.29 to 0.67)

I2 = 82%
No data

Audio-visual19

(19 arms)
8 studies

(8 arms)

SMD 0.72 (0.40 to 1.04) I2 = 71%
4 studies

(4 arms)

SMD 0.73

(0.14 to 1.32)

I2 = 91%
No data5 studies

(5 arms)

SMD -0.48

(-1.07 to 0.12)

I2 = 86%
4 studies

(4 arms)

SMD 0.08

(-0.32 to 0.47)

I2 = 53%
No data4 studies

(4 arms)

SMD 0.05

(-0.11 to 0.21)

I2= 0%

Dichotomous data

4 studies

RR 1.10

(0.91 to 1.34)

I2 = 93%
No data

Interactive multimedia6

(6 arms)
No data3 studies

(3 arms)

SMD 0.47 (0.16 to 0.77) I2 = 43%
No dataNo dataNo dataNo data3 studies

(3 arms)

SMD 0.23

(-0.46 to 0.92) I2 = 89%
No data

Structured consent6

(6 arms)
5 studies

(5 arms)

SMD 0.43 (0.16 to 0.70) I2 = 57%
No dataNo dataNo dataNo dataNo dataNo dataNo data

Decision aids and mixed9

(9 arms)
4 studies

(4 arms)

SMD 0.64 (0.26 to 1.02)

I2 = 81%
3 studies

(3 arms)

SMD 0.35 (0.12 to 0.59)

I2 = 55%
No dataNo dataNo dataAs above in ‘all interventions’No data7 studies

(7 arms)

SMD 2.64 (1.50 to 3.77) I2 = 99%

Before admission for procedure38

(42 arms)

 
8 studies

(10 arms )

SDM 0.50 (0.16 to 0.85) I2 = 86%
Not analysedNot analysedNot analysed8 studies

(10 arms)

SMD -0.12

(-0.33 to 0.09)

I2= 50%
3 studies as above in ‘all interventions’7 studies

(8 arms)

SMD 0.14

(-0.12 to 0.41)

I2= 74%

Dichotomous data

4 studies

RR 1.12

(0.94 to 1.33)

I2 = 91%
As above in ‘all interventions’

8 studies

During admission for procedure24

(27 arms)
13 studies

(15 arms )

SDM 0.55 (0.40 to 0.70)

I2 = 40%

 

 
No dataNo dataNo data3 studies

(3 arms)

SMD 0.41

(0.19 to 0.62)

I2= 0%
No data6 studies

(6 arms)

SMD 0.10

(-0.26 to 0.46)

I2= 81%

Dichotomous data

6 studies

RR 1.00

(0.96 to 1.04)

I2 = 4%
No data