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Educational and behavioural interventions for anticoagulant therapy in patients with atrial fibrillation

  1. Danielle E Clarkesmith1,
  2. Helen M Pattison2,
  3. Deirdre A Lane1,*

Editorial Group: Cochrane Heart Group

Published Online: 4 JUN 2013

Assessed as up-to-date: 8 AUG 2012

DOI: 10.1002/14651858.CD008600.pub2


How to Cite

Clarkesmith DE, Pattison HM, Lane DA. Educational and behavioural interventions for anticoagulant therapy in patients with atrial fibrillation. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD008600. DOI: 10.1002/14651858.CD008600.pub2.

Author Information

  1. 1

    University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK

  2. 2

    Aston University, School of Life and Health Sciences, Birmingham, Birmingham, UK

*Deirdre A Lane, University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Dudley Road, Birmingham, B18 7QH, UK. deirdrelane@nhs.net.

Publication History

  1. Publication Status: New
  2. Published Online: 4 JUN 2013

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Characteristics of included studies [ordered by study ID]
Beyth 2000

MethodsRandomised, controlled, parallel-groups design


ParticipantsN randomised: 132 versus 162 usual care

Diagnosis of ppts: AF n=54 (16.6%) for the intervention group and usual care groups. Other indications include venous thromboembolism, cerebrovascular disease, heart valve prosthesis, peripheral vascular disease, myocardial infarction

Demographics for total cohort:

Age:74.9±6.9 versus 74.5±6.6

% female: 55 versus 59% usual care

% white: 69% versus 65% usual care

Mean number of school years 12.1±4.4 [intervention], 12.1±4.1 [usual care]

Demographics for AF patients:

Age: 74.6±6.8 intervention versus 75.5± 6.2 usual care

% female: 40% versus 66% usual care

% white: 77% versus 77% usual care

Mean number of school years 14.5±4.9 [intervention], 12.0±3.9 [usual care]

Inclusion/exclusion criteria: Patients hospitalised and receiving 10000 units or more of intravenous heparin, were 65 years or over, for whom warfarin treatment was planned for 10 days or more. Patients were excluded if they had been treated with warfarin at any time in the previous 6 months, were admitted from a nursing home, were enrolled in another clinical trial, were too ill to give consent or did not speak English.


InterventionsType: Guideline-based consultation, Education and self-monitoring

Content: A consultation that assessed the patients indication for therapy and potential risks for warfarin related bleeding (a method used by the researchers previously). This included specific recommendations about modifiable risk factors, such as use of non-steroidal anti-inflammatory drugs.The other component included patient education, coaching and self monitoring. Patient education consisted of one to one teaching by a lay educator using a specifically formatted workbook for older adults to teach them about warfarin, indications for its use, drug and food interactions, and the signs and symptoms of bleeding. Coaching aimed to increase patients participation in their care and improve information seeking-skills. Self-monitoring of prothrombin time (grounded in social learning theory). Patients were taught to self-monitor prothrombin time. Patients instructed to use monitor 3 times in first week and once weekly after that.

Duration: 30 minutes-1 hour (consultation)

Facilitator: lay educator

Setting: hospital


OutcomesIncidence of major bleeding

Excessive anticoagulation

Rates of VTE


CountryCleveland, Ohio, USA


ComparisonUsual care group


Length follow-up6 months


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients were stratified according to their baseline risk for major bleeding by using the outpatient bleeding risk index. The index includes 4 independent risk factors for major bleeding: age 65 or older, history of gastrointestinal bleeding, history of stroke, and one or more of four specific comorbid conditions (myocardial infarction, hematocrit<30%, creatinine concentration> 133µmol/L (1.5mg/dL), or diabetes mellitus). Patients with one or two risk factors were classified as intermediate risk, and those with 3 or more risk factors were classified as high risk; estimated frequencies of major bleeding in 6 months were 6% and 35% respectively.

Allocation concealment (selection bias)Low risk426 eligible patients were identified, 294 (69.0%) received either usual care or the intervention. This indicates low risk of selection bias.

Blinding (performance bias and detection bias)
All outcomes
Low riskThe educational intervention was delivered by a lay educator that was not involved in the treatment of the patients.

Incomplete outcome data (attrition bias)
All outcomes
High risk81% (n=132) of the 163 patients assigned to the intervention group participated in the intervention. 12 patients felt more comfortable with venipuncture, 3 stopped warfarin during hospitalisation, and 1 was discharged to a nursing home that precluded the use of a portable monitor. At 6 months 21 patients (13%) in the intervention group and 26 (16%) of the usual care group had died.

Selective reporting (reporting bias)Low riskThe method section describes the primary outcome as first major bleeding event during the 6 month intervention period. Secondary outcomes were death and recurrent VTE at 6 months; major bleeding after 6 months and INR control during the first 6 months of therapy. The authors report data on all of these outcomes.

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants cannot be blinded to which arm of the trial they receive. Neither can the personnel delivering the intervention be blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskTrained abstractors who were not involved with the intervention component of the study collected data from the medical chart at the start of OAC, and by blinded interview at enrolment at 1, 3, 6 months after enrolment and every 6 months thereafter. Whenever an event was reported, the clinical characteristics of the bleeding or thromboembolic episode were determined by review of the relevant medical record and abstracted without identifying the patient onto a standard form.

Christensen 2007

MethodsOpen-label randomised controlled trial, cross-over (6 months)


ParticipantsN randomised: 47 versus 45 (usual care/conventional management)

AF: n=11 versus n=9 (usual care), other indications include mechanical heart valve, coagulopathies, VTE, synthetic vascular graft

Demographics for total cohort:

Age: 51.5±14.4 versus 46.3±13.4 (usual care)

% female: 23% versus 44% (usual care)

% white: not stated

% education above primary level: not stated

Demographics for AF cohort:

Age (SD): 59 (18) versus 51 (12)

% female: 0% intervention versus 7% usual care

% white: 100% in both groups

% high school or greater: 4% versus 3% usual care

Inclusion/exclusion criteria:

Patients were eligible if they were referred for patient self-management by a general practitioner or hospital department, treated with oral anticoagulants >8 months, 18 years or over, willing to be randomised. Patients were excluded if they had previously used self-management or lived abroad.


InterventionsType: Teaching lesson (not explained in detail) and patient self-management (PSM)

Content: The group used Coagucheck, which displays the INR value after the application of a drop of blood. Self-management training included patient practicing analysis of blood specimens. The patient gradually assumed management of OAC. After 27 weeks patients took an exam, if passed patient went on to self-manage. After 6 months the conventional management group started the same training.

Duration: not stated

Facilitator: not stated

Setting: hospital


OutcomesMajor complications (bleeding and thromboembolism requiring intervention)

Death and/or discontinuation of the study

Primary endpoint: variance of INR in trial and control samples

TTR


CountryAarhus, Denmark


ComparisonConventional management


Length follow-up0bservation period

1) 8-12 months before randomisation

2) primary observation period (6 months of either patient self-management or conventional management)

3) patient self-management training (27 weeks)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients were randomly assigned to patient self-management using a computerised, prospective, randomisation schedule. Randomisation in blocks with various sizes in numbers of 2,4, and 6 was used.

Allocation concealment (selection bias)Low risk105 patients were eligible to take part in the study and 100 patients were randomised (95%), therefore there is a low risk of selection bias.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskIt was unclear whether the personnel delivering the intervention was also involved in treating the usual care arm.

Incomplete outcome data (attrition bias)
All outcomes
Low riskIn the self-management arm three patients dropped out, two during the training period, and one died. In the usual care arm of the study one patient was withdrawn by the physician and four dropped out during the self-management training. Thus 92% of original cohort participants were included in the analysis.

Selective reporting (reporting bias)Low riskThe endpoints were the variance (mean square of standard deviation) of the INR value, the median INR value (using a blinded control sample analysed monthly by a reference laboratory) and the coumarin dose. All outcomes were reported.

Blinding of participants and personnel (performance bias)
All outcomes
High riskDue to the nature of the intervention, the participants receiving the intervention and the personnel delivering it cannot be blinded to which arm of the intervention they are in.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskExternal control blood samples were blinded. The results of the INR analysis was blinded for all except one secretary who would ensure the safety of the patient by contacting the managing physician if the INR value was below 1.5 or above 4.5.

Gadisseur 2003

MethodsMulticentre randomised study, 4 arms


ParticipantsN randomised: A) weekly self-measurement n=52; B) weekly self measurement and self-dosing n=47; C) educated routine care n=60; D) existing routine care (not trained) n=161. This study used a Zelen design

Diagnosis of ppts: number of AF patients in group A=6 (11.6%), group B=9 (19.2%), group C=10 (16.6%), and group D=43 (26.7%). Other indications included DVT, PE, artificial heart valves, vascular prosthesis

Demographics for total cohort:

Age: mean age A=54.8 (25-74), B=53.9 (24-75), C=56 (21-73), D=62 (32-75)

% female: A=23%, B=32%, C=40%, D=46%

% white: not stated

% education above primary level: not stated

Demographics for the AF patients: not provided

Inclusion/exclusion criteria:

At least >3 months of OAT experience, need for long-term OAT, aged 18-75. Patients were excluded if they had antiphospholipid syndrome, a life threatening illness, life expectancy ≤1 year, diminished understanding, and physical limitations making successful participation impossible.


InterventionsType: self-management and self-dosing including education

Content: They received information about the study, the blood coagulation system, OAT, and the effects of some substances (eg. alcohol, certain medications and foods rich in vitamin K) on OAT; then they were also taught how to use Coagucheck device, and instructed on oral self-dosing of phencoumon and acenocoumarol. This also contained practical information about working with the Coagucheck, information about the coagulation system, theoretical and practical self-dosing training. They were also given written information on all the topics discussed.

Group A: weekly INR self-measurement, but dosing was performed by anticoagulation clinic physicians. Patients reported their INR values by telephone to the anticoagulation clinics. Dosing schedules communicated via telephone.

Group B: this group self-managed their OAT, patients informed the anticoagulation clinic of their INR measurements, proposed dosing schedules and reported any relevant information or complications. Patients were contacted via telephone to confirm whether they could adhere to their proposed dosing schedule or if they needed to adjust it.

Group C: patients were trained for inclusion in groups A or B but stayed with the routine care system. Measurements of INR and dosing were done by anticoagulation clinic physicians, and the interval between INR measurements depended on the stability of the INR values.

Group D: patients in this group were unaware of their participation in the study, representing the existing care system.

Duration: 3 training sessions, groups of 4-5, 90-120 minutes

Facilitator: delivered by physician, paramedical person

Setting: hospital


OutcomesQuality of life (questionnaire developed by Sawicki et al), 32 items, validated. The questionnaire was meant to measure patient concerns, the impact of self-monitoring of INR, and the possibility of increased education. Translated from German to Dutch and marginally altered for relevance in the Netherlands


CountryNetherlands


ComparisonA) weekly self-measurement

B) weekly self-measurement and self-dosing

C) educated routine care

D) existing routine care (not trained)


Length follow-upMean follow-up time 24.5 weeks


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe patients were selected by groups of 40 and randomised to 4 treatment groups (A, B, C and D) following a 2-step partial zelen design.

Allocation concealment (selection bias)High riskOf the 881 eligible participants, 159 (18%) were randomised, therefore this study is at high risk of inclusion bias. 916 patients were randomly selected by a computer, 35 (3.9%) were excluded because of intellectual or physical limitations or because of a life expectancy of < 1 year.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe authors do not state whether those physicians delivering the intervention also treated the usual care arm.

Incomplete outcome data (attrition bias)
All outcomes
High risk116 (64%) of the original 180 patients randomised to the study completed the quality of life questionnaires at baseline and follow-up. 21 patients were withdrawn or ineligible and the remainder were lost to follow-up.

Selective reporting (reporting bias)Unclear riskPre-specified endpoints were (1) quality of OAT represented by the number of INR readings within target range (TTR); (2) patients ability to independently perform anticoagulant self-dosing, by number of dosage corrections made. All specified outcomes were reported.

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients who were not randomised to group D were sent a letter with written information about the study (thus not blinded). Knowledge of the composition of the different groups was restricted to a few nurses who were also responsible for anonymously transferring the dosing schedules for group A and group B patients to standard forms and faxing them to the other participating anticoagulation clinics. The patients and staff could not be blinded to which arm of the trial participants were assigned to.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe physicians evaluating and correcting the proposed dosing schedules for group A and B were unaware of the originators of these schedules. The INR values of the patients in routine care groups C and D were entered into the routine computerised system in such a way that the dosing physicians could not distinguish between these and the general patient population.

Man-Son-Hing 1999

MethodsRandomized controlled trial

20 possible SPAF trial centres invited, 14 participated


ParticipantsN randomised: intervention n= 139 (10 lost to follow-up); control n=148 (14 lost to follow-up)

Diagnosis of ppts: all atrial fibrillation

Demographics of cohort:

Age: intervention mean=65, control mean=65

% female: intervention 24%, control 24%

% white: not stated

% education above primary level: intervention 90% high school education or greater, control 91% high school education or greater

Inclusion/exclusion criteria: all participants were in the SPAF III aspirin cohort study and were eligible unless they had high risk criteria or had a major haemorrhage during the study.


InterventionsType: decision aid

Content: 29 page booklet, a personal worksheet (complete pre-intervention), 20-minute audiotape that guided the patient through the booklet and worksheet. The intervention included a description of the consequences of minor/major stroke and major haemorrhage, the blood monitoring required for warfarin and the 2-year probability of stroke and major haemorrhage for patients taking aspirin/warfarin using pictograms.

Duration: not stated

Facilitator: physician/audio tape

Setting: hospital


Outcomes1-4 days after meeting with their physicians patients completed questionnaires

Patient choices (strength of their decisional input, 5-point Likert scale, unvalidated)

Knowledge (23 questions about AF, stroke and treatment, unvalidated)

Expectations (4 questions regarding patient expectations of stroke/haemorrhage, unvalidated)

Decisional conflict (decisional conflict scale, ref: O’Connor 1995)

Satisfaction (6 questions, 5-point Likert scale, unvalidated)

Six-month adherence to their treatment decisions (self-report brief questionnaire, administered via telephone, unvalidated)


CountryUS


ComparisonControl group, usual care, i.e. no change was made to the usual manner in which each centre communicated the results of the SPAF III study or the way in which the decision regarding type of antithrombotic was made.


Length follow-up6-month follow-up


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated scheme, administered from a central location to block sequence from previewing. Stratified by centre and the presence of a history of hypertension.

Allocation concealment (selection bias)High risk657 patients were eligible for the trial, 287 participated (43%), giving a substantial risk of inclusion bias. 24 participants were lost to follow-up.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe authors do not state whether those physicians delivering the intervention also treated the usual care arm.

Incomplete outcome data (attrition bias)
All outcomes
Low risk87 (63%) worksheets from 139 patients participating were completed. However, all of the 139 patients randomised to the decision aid were included in the study analysis of decision conflict.

Selective reporting (reporting bias)Low riskOutcome measures were patients' ability to make choices regarding antithrombotic therapy, 6-month adherence to decision, knowledge, decision conflict and satisfaction. There was no protocol paper for this study. However, one of the pre-specified outcome variables in the method section was not reported (patient satisfaction).

Blinding of participants and personnel (performance bias)
All outcomes
High riskThe authors do not state whether the researcher or personnel were blinded to which arm the participants were randomised to. However, we can assume that participants and physicians were not blinded to treatment allocation due to the nature of the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe authors do not state whether the personnel scoring and analysing the questionnaires were blinded to the treatment allocation.

McAlister 2005

MethodsProspective, multicentre, two-arm, cluster randomised trial.


ParticipantsN randomised: intervention n=219, control n=215

50 GP practices were randomised to the decision aid group and 52 were randomised to usual care

Diagnosis of participants: All NVAF (also broken down type of AF, see paper)

Demographics of cohort:

Age: intervention 73±9; controls 71±10

% female: intervention 43%, controls 34%

% white: not stated

% education above primary level: completed high school: intervention n=84 (38%), usual care n=72 (33%)

Inclusion/exclusion criteria: community-dwelling patients, over the age of 18, will be included in this study if they have a diagnosis of NVAF (intermittent or chronic) confirmed by ECG or prescription for digoxin. They were excluded if they had 1) valvular AF; 2) taking warfarin for another condition; 3) are scheduled for cardioversion; 3) have a contraindications for warfarin or aspirin; 4) cognitive impairment; 5) their life expectancy is less than 12 months; 6) cannot understand/converse in English.


InterventionsType: general education session plus patient decision aid and physicians manual

Content: 30-page decision aid booklet, personal worksheet, 50-minute audiotape to guide participants through the booklet and worksheet, and a 7-page physicians manual summarising the evidence discussed in the patient booklet with a focus on the 2001 ACCP risk stratification schema and recommendations for antithrombotic therapy. 4 versions of the decision aid were available depending on patient’s baseline stroke risk. All four versions provide the same background information about AF; the potential consequences of stroke and major haemorrhage, relative efficacy/bleeding risks with warfarin and aspirin therapy. Key points are further elaborated upon in the audio-tape. The 1 page worksheet is to be completed by the patient after reviewing the booklet to clarify their personal values regarding desired outcomes, the therapy they are inclined to take, their preferred role in the decision process, and any questions they have for their physician.

Duration: not stated

Facilitator: physician

Setting: GP practices


OutcomesUse of appropriate antithrombotic therapy at 3 months, as defined by the 2001 ACCP recommendations. Secondary outcomes include (1) appropriate antithrombotic therapy at 6 months and 12 months, (2) patient’s readiness to make a choice at baseline (previously validated questionnaire, with reference), (3) patient knowledge after the intervention (multiple-choice responses used in previous trial, with reference), (4) decisional conflict - decision conflict scale (O’Connor), (5) acceptability of decision aid (9 questions with variable responses on a 5-point Likert scale), (6) satisfaction (5-point Likert scale), (7) adherence with therapy (validated Morisky scale with modified 5-point Likert scale response).


CountryCanada


ComparisonUsual care


Length follow-up1-year follow-up


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation to intervention or usual care is being carried out according to a computer-generated sequence using clustered block randomisation (block size of four) with allocation concealment.

Allocation concealment (selection bias)High risk904 patients were eligible for the study. 446 patients were randomised (49%). Due to the number of patients declining screening, there is an increased risk of inclusion bias.

Blinding (performance bias and detection bias)
All outcomes
Low riskPhysicians that delivered the intervention did not treat the usual care arm.

Incomplete outcome data (attrition bias)
All outcomes
Low risk446 eligible participants were randomised. 434 (97%) were included in the 3-month follow-up evaluation.

Selective reporting (reporting bias)Low riskThe primary endpoint was use of appropriate antithrombotic therapy, other endpoints include TTR, patients readiness to make choices, knowledge, decision conflict, acceptability of decision aid, satisfaction, and adherence. Adherence and satisfaction scales data are not explained in detail. However, authors report the majority of data from the protocol paper including key primary and secondary outcomes.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskThe authors do not state whether the researcher or personnel were blinded to which arm the participants were randomised to. However, we can assume that participants and physicians were not blinded to treatment allocation due to the nature of the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe outcome assessment was carried out by an independent statistician who was blinded to group allocation.

Polek 2012

MethodsNested randomised controlled trial


ParticipantsN randomised: intervention=25, usual care = 28

Mixed indication cohort

Demographics of the cohort: mean (SD) age = 63.71 (16.04)

% female: not stated

% white: not stated

% educated above primary school level: not stated

Demographics of the AF patients: N=14

Treatment group n= 5; usual care n= 9

Age, mean (SD): intervention = 73.6 (11.1), usual care = 76 (13.4)

% female: intervention = 4/5 (80%), usual care = 3/9 (33%)

% white: intervention = 3/5 (60%), usual care = 5/9 (55%)

% educated above primary school level: not available

Inclusion criteria: patients discharged to home on OAT, alert and orientated, able to speak and understand English, and accessible via telephone

Exclusion criteria: patients discharged to a nursing home or rehabilitation facility, history of psychotic disorder or cognitive impairment


InterventionsType: Enhanced educational intervention

Content: face-to-face warfarin education, printed materials, instruction, medical alert bracelet. The intervention was based on Banduras social cognitive model and aimed to improve self-efficacy. Four post-discharge phone calls assessing knowledge post-intervention and correcting incorrect answers.

Duration: not stated

Facilitator: pharmacist

Setting: hospital


OutcomesWarfarin knowledge

Self-efficacy


CountryUSA


ComparisonUsual care


Length follow-up12 weeks


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskPatients were randomly assigned to the intervention or usual care group after receiving patient education from the pharmacist. Authors do not describe the sequence generation.

Allocation concealment (selection bias)Low risk66 patients were screened and offered participation in the study. There were 53 patients included in the original randomised sample (80% of those screened), with a low risk of inclusion bias. 42 of the original sample of 53 completed the study (79%).

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe authors do not state whether the personnel delivering the intervention also treated the usual care arm.

Incomplete outcome data (attrition bias)
All outcomes
High riskThe final sample included 42 (79%) of the original 53 patients that were randomised to the study.

Selective reporting (reporting bias)Low riskThe authors describe two outcomes in their method section (1) warfarin knowledge and (2) self-efficacy. The authors report on both outcomes in their results section. There was no published protocol paper, thus we cannot determine whether those outcomes reported reflect those that were included in the study.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskThe authors do not state whether the researcher or personnel were blinded to which arm the participants were randomised to. However, we can assume that participants and physicians were not blinded to treatment allocation due to the nature of the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskAuthors do not state whether the person scoring the questionnaires was blinded to the treatment allocation.

Thomson 2007

MethodsThree/2-armed open, randomised controlled efficacy trial


ParticipantsN randomised: 69 decision aid versus 67 guidelines

% AF: all AF patients

Demographics of cohort:

Age: 73.1±6.7 decision aid versus 73.7±6.2 guidelines

% female: 43.4 decision aid versus 44.6 guidelines

% white: not stated

% education above primary level: not stated

Inclusion/exclusion criteria: patients were recruited if they were already taking warfarin or if they were considering taking warfarin for the first time. Patients were eligible if they aged 60 or over and had either chronic NVAF or PAF. Patients were excluded if they were acute onset AF requiring cardioversion, previous stroke or TIA, contraindications for warfarin, taking warfarin for other indications, cognitive impairment, non-English speaking, or at risk of cerebral bleed.


InterventionsType: decision aid

Content: included individual risk and benefit presentation and a section to support shared decision making

2 different decision aids

1. Used explicit value elicitation employing the standard gamble method and Markov decision analysis “explicit tool”

2. Included only risk/benefit presentation “implicit tool” (computerised decision aid). The doctor was trained to use the computerised decision aid.

Early in the trial, the observation study (running alongside the trial) found the first decision aid to be difficult, so this arm was discontinued (gamble method) and the paper describes the results of the second arm versus evidence-based paper guidelines. The intervention arm included benefits and harms of warfarin treatment, advantages and disadvantages, personalised risk assessment (using the Framingham equation). The presentation used graphical and numerical forms of presentation.

Duration: mean 31 minutes long (range 16-41)

Facilitator: computerised tool

Setting: research clinic


OutcomesDecision conflict

Knowledge

State trait anxiety inventory

Degner’s decision making preference scale


CountryNewcastle, UK


ComparisonGuideline-based consultation


Length follow-up3 months


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskParticipants were randomised to either: (a) computerised decision aid (intervention) or (b) evidence-based paper guidelines (control), using electronically-generated random permuted blocks via a web-based randomisation service provided by the Centre for Health Services Research.

Allocation concealment (selection bias)High risk483 patients were eligible for the study, 145 patients were eventually randomised (30%). Thus there is a substantial risk of inclusion bias.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe authors do not state whether those physicians delivering the intervention also treated the usual care arm.

Incomplete outcome data (attrition bias)
All outcomes
Low risk16 (23%) of the 69 patients allocated to the decision aid tool did not receive the intervention. 11 (16%) of the 67 patients allocated to the guidelines group did not receive the intervention. In total 19% of patients randomised did not receive the intervention. Reasons included withdrawal of consent, death, illness, surgery, alcoholism, and inability to use the tool.

Selective reporting (reporting bias)Unclear riskThe primary outcome was decision conflict. Secondary outcomes were state trait anxiety, knowledge and decision making preference. Decision conflict outcomes were reported, but there was no tabulated report of the scale breakdown. All of the outcomes were reported, but mean scores and numbers of patients per group were not.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskThe authors do not state whether the researcher or personnel were blinded to which arm the participants were randomised to. However, we can assume that participants and physicians were not blinded to treatment allocation due to the nature of the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe authors do not state whether the person scoring the questionnaires was blinded to the treatment allocation.

Voller 2005

MethodsProspective multicentre randomised controlled trial


ParticipantsN randomised: 101 self-management versus 101 family doctor group

All NVAF patients

Demographics of cohort:

Age: 64.6±9.6 self-management versus 64.1±8.9 family doctor

% female: 28.6 self-management versus 38.6 family doctor

% white: not stated

% education above primary level: not stated

Inclusion/exclusion criteria: all patients whom long-term anticoagulation was indicated because of permanent non-valvular atrial fibrillation were to be included into the investigation. Exclusion criteria were the lack of suitability for INR self-management, participation in another study, alcohol or other addiction, a mechanical heart valve replacement or anticoagulant treatment already administered for another indication and diseases such as AIDS or carcinomas. Patients with visual impairment were also excluded.


InterventionsContent: educational session following the standards of the working group for self monitoring of anticoagulation ASA. Based on the intervention session developed my Sawicki and colleagues (ref 12). The programme consisted of three consecutive weekly teaching sessions for groups of 3 to 6 patients. Topics included anticoagulation in general, INR self-monitoring, preventing bleeding, effects of diet and other medication, reducing or increasing dose, problems that may be encountered with operations, illness, exercise, pregnancy etc.

Duration: 60-90 minutes (based on Sawicki's description)

Facilitator: not stated

Setting: not stated


OutcomesPrimary endpoint: number of thromboembolic or hemorrhagic complications requiring treatment

Secondary endpoints: the degree of handicap after stroke, the degree of severity of haemorrhage, the proportion as well as cumulative time of the INR values in the individual target range, INR variance, time course of complications and the cost efficiency of self-measurement compared to conventional procedures.


CountryGermany


ComparisonFamily doctor group


Length follow-upOverall observation period (retrospective):

self-management 37.34±5.93 years

family doctor 40.25±6.07 years


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation list developed before beginning of the study with SAS-procedure PROC PLAN.

Allocation concealment (selection bias)Unclear riskAuthors do not report how many participants were eligible for the study.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe authors do not state whether those physicians delivering the intervention also treated the usual care arm.

Incomplete outcome data (attrition bias)
All outcomes
Low risk202 patients were randomised to the study and all of these patients were included in the final analysis.

Selective reporting (reporting bias)High riskThe study was discontinued because the number of cases was too small, and the group comparison was confined to the evaluation of the number of INR values measured and the total period for which the patients remained outside, above and below the target range.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskThe authors do not state whether the researcher or personnel were blinded to which arm the participants were randomised to. However, we can assume that participants and physicians were not blinded to treatment allocation due to the nature of the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe authors do not state whether the person scoring the questionnaires was blinded to the treatment allocation.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Armstrong 2011Not an RCT

Bajorek 2005Not an RCT, no control group

Baker 1991Wrong patient group, no AF

Barcellona 2006No unpublished AF data provided on request

Batty 2001Does not measure any of the required outcomes

Blaise 2009Not an RCT, retrospective study

Bloomfield 2011Meta-analysis, not an RCT

Bump 1977No AF patients

Burns 2009Not an RCT, review paper

Castelino 2010Not an RCT

Chan 2006No unpublished AF data provided on request

Christensen 2011Limited education, specific to self-testing

Claes 2005No AF patients

Claes 2006No AF patients

Corbella 2009Not an RCT

Cordasco 2009No AF patients

Cromheecke 2000No AF patients

Cromheecke 2001No AF patients

Davis 2005Not an RCT, survey

Dolor 2010No education other than instruction to self-test

Duran-Parrondo 2011Trial is not randomised

Field 2010Training is for staff not patients

Fitzmaurice 1996Not a patient intervention

Fitzmaurice 2000Did not include an educational or behavioural intervention

Fitzmaurice 2005No AF patients

Fraenkel 2011Not compared to usual care, not an RCT

Gardiner 2006No unpublished AF data provided on request

Gouin-Thibault 2010Intervention for staff not patients

Grunau 2011Patients were educated on self-monitoring only

Hasan 2011Not an RCT

Holbrook 2007No AF patients

Jackson 2004Does not measure any of the required outcomes

Khan 2004Randomisation procedure did not meet inclusion criteria

Krause 2010Systematic review not an RCT

Landefeld 1992No AF patients

Leger 2004Not an RCT, wrong patient group

Machtinger 2007No unpublished AF data provided on request

Matchar 2005No education or behaviour change within the intervention

Matchar 2010Self-monitoring only, no educational or behavioural intervention

Mazor 2007No AF patients

McCahon 2011No breakdown of patient group

Megden 1999Not an RCT

Menendez-Jandula 2005No unpublished AF data provided on request

Nedaz 2002Not an RCT, this paper is a commentary

Nilsson 2011Abstract only, no mention of AF patients

Pernod 2008No AF patients

Polzien 2007Not an RCT, commentary

PRISM Study group 2003Does not include any of the primary or secondary outcomes

Reverdin 2011Not an RCT

Ryan 2009No unpublished AF data provided on request

Saokaew 2010Systematic review and meta-analysis, not an RCT

Satger 2009Not an RCT, review article

Sawicki 1999No unpublished AF data provided on request

Sawicki 2003Not an RCT, no comparison group

Siebenhofer 2007No unpublished AF data provided on request

Stone 1989No unpublished AF data provided on request

Sunderji 2005Education only relates to self-monitoring

Taylor 1997Not an RCT

Trivalle 2010Education of staff not patients

Tuiskula 2011Not an RCT

Vadher 1996No breakdown of patient group

Vadher 1997No breakdown of patient group

Waterman 2001No AF patients, no comparison group

Waterman 2001 bNo patient intervention

Watzke 2000No unpublished AF data provided on request

Winans 2010Not an RCT

Witt 2005Not an RCT, retrospective, observational cohort study

Woodend 2005Not an RCT (commentary)

Wurster 2006Not an RCT

 
Characteristics of ongoing studies [ordered by study ID]
Hua 2011

Trial name or titlePractice nurse-based, individual and video-assisted patient education in oral anticoagulation - Protocol of a cluster-randomized controlled trial (No trial acronym)

MethodsCluster randomised controlled trial of 22 GP practices

ParticipantsAll patients taking OAT (with a range of indications)

InterventionsEducational intervention including a video, brochure and individual training session versus usual care

OutcomesPrimary outcome: number of correctly answered questions from the 13-item OAT questionnaire

Secondary outcomes: time spent in therapeutic range, subjective feelings of safety and complications related to OAT

Starting dateJanuary 2011

Contact informationthanhduchua@med.uni-goettingen.de

Notes

Smith 2010

Trial name or titleTRial of an Educational intervention on patients' knowledge of Atrial fibrillation and anticoagulant therapy, INR control, and outcome of Treatment with warfarin (TREAT)

MethodsRandomised controlled trial

ParticipantsNewly diagnosed AF patients

InterventionsOne-off one-hour educational intervention, with DVD, consultation, worksheet and booklet

OutcomesTTR, knowledge, illness perceptions, beliefs about medication, cost-effectiveness, hospital anxiety and depression, quality of life, stroke, thromboembolic events, major and minor bleeding.

Starting dateDecember 2010

Contact informationd.a.lane@bham.ac.uk

Notes

Stafford 2011

Trial name or titleA role for pharmacists in community-based post-discharge warfarin management: protocol for the 'the role of community pharmacy in post hospital management of patients initiated on wafarin' study (No acronym)

MethodsProspective controlled cohort study

ParticipantsAll patients discharged from hospital on warfarin

InterventionsPost-discharge warfarin management service, visits involve a home medicines review, warfarin education, provision of resources dependent on patients understanding and INR monitoring

OutcomesPrimary outcome: proportion of patients experiencing a major bleeding event in the 90 days after hospital discharge

Secondary outcomes: INR control (TTR), warfarin-related adverse events, warfarin knowledge, QoL, adherence

Starting date2011

Contact informationleanne.stafford@utas.edu.au

Notes

 
Comparison 1. Time in therapeutic INR range

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Time in therapeutic INR range269Mean Difference (IV, Random, 95% CI)6.31 [-5.63, 18.25]

 
Comparison 2. Decision conflict

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Decision conflict2721Mean Difference (IV, Random, 95% CI)-0.10 [-0.17, -0.02]