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Implementation of treatment guidelines for specialist mental health care

  1. Corrado Barbui1,*,
  2. Francesca Girlanda1,
  3. Esra Ay2,
  4. Andrea Cipriani3,
  5. Thomas Becker2,
  6. Markus Koesters2

Editorial Group: Cochrane Schizophrenia Group

Published Online: 17 JAN 2014

Assessed as up-to-date: 10 JUL 2012

DOI: 10.1002/14651858.CD009780.pub2


How to Cite

Barbui C, Girlanda F, Ay E, Cipriani A, Becker T, Koesters M. Implementation of treatment guidelines for specialist mental health care. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No.: CD009780. DOI: 10.1002/14651858.CD009780.pub2.

Author Information

  1. 1

    University of Verona, Department of Public Health and Community Medicine, Section of Psychiatry, Verona, Italy

  2. 2

    Ulm University, Department of Psychiatry II, Guenzburg, Germany

  3. 3

    University of Oxford, Department of Psychiatry, Oxford, UK

*Corrado Barbui, Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico "GB Rossi", Piazzale L.A. Scuro, 10, Verona, 37134, Italy. corrado.barbui@univr.it.

Publication History

  1. Publication Status: New
  2. Published Online: 17 JAN 2014

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This is not the most recent version of the article. View current version (15 DEC 2016)

 
Characteristics of included studies [ordered by study ID]
Baandrup 2010

MethodsAllocation: cluster-randomised trial.

Blindness: not blind, outcome data from computerised prescription drug records.

Duration: 12 months.


ParticipantsDiagnosis: schizophrenia; schizotypal, delusional and schizoaffective disorders.

N of clusters = two municipalities, balanced for baseline. prevalence of antipsychotic polypharmacy, socioeconomic status (of population in catchment areas) and functional level of inpatients and outpatients.

N of participants = 216 (experimental group); 386 (control group).

Sex: 56.9% M (experimental group); 57.5% M (control group).

Mean age, years: 38.8 (experimental group); 37.5 (control group)

Setting: outpatients in Denmark.


Interventions1. Multifaceted educational intervention consisting of one day (six hours) of traditional education (didactic lectures), where current evidence for the psychopharmacological treatment of schizophrenia and existing clinical guidelines were presented, with special emphasis on avoiding ⁄ reducing irrational antipsychotic polypharmacy. In addition, six times during the following year, a 3-hour session with case-based education was offered. Finally, a warning implemented in the electronic drug prescribing system popped up every time antipsychotic polypharmacy was about to be prescribed. Target of the intervention: doctors, nurses, psychologists, other professionals.

2. Routine care.


OutcomesPractitioner impact: antipsychotic polypharmacy (review of computerised prescription drug records).


NotesMean number of participants per cluster (m): 301.

Intraclass coefficent (ICC): not reported.

Design effect: 31.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationUnclear riskTwo Danish municipalities were randomly assigned to intervention (Viborg) and control settings (Esbjerg).

Allocation concealmentUnclear riskNo details reported.

Blinding
All outcomes
Unclear riskParticipants might have been aware of the group (control or intervention) to which they were allocated because of the nature of the intervention. The two clusters were situated sufficiently far away from each other that contamination was avoided.

Incomplete outcome data addressed
All outcomes
Low riskThe two randomly assigned units (clusters) were included in the analysis. The study consisted of two cross-sectional surveys—one carried out at baseline and the second after one year of follow-up. The primary outcome was prevalence of polypharmacy at follow-up (cross-sectional nature of the primary outcome measure).

Free of selective reportingLow riskAll study measures reported in the Methods were described in the analysis and reported in the Results.

Free of other biasLow riskThe control group and the intervention group were perfectly matched regarding prevalence of antipsychotic polypharmacy at baseline. The study was supported by the National Board of Health in Denmark (0-204-03-9 ⁄ 9) and the Wørzner Foundation.

Hamann 2006

MethodsAllocation: cluster-randomised trial.

Blindness: not blind.

Duration: 18 months.


ParticipantsDiagnosis: schizophrenia or schizophreniform disorder.

N of clusters: 12 acute psychiatric wards.

N of participants: 107.

Sex: 59% M (experimental group); 47% M (control group).

Mean age, years: 35.5 (experimental group); 39.6 (control group).

Exclusion criteria: severe mental retardation, lack of fluency in German and refusal to give written informed consent.

Setting: two German state hospitals.


Interventions1. Printed decision aid plus planning talk. A printed decision aid was initially developed in co-operation with a number of psychiatrists, psychiatric nurses and former patients. The final version of the decision aid was a 16-page booklet covering the pros and cons of oral versus depot formulations, first- versus second-generation antipsychotics, psychoeducation and types of sociotherapeutic interventions. These booklets were presented to participants through the head nurse of the ward as soon as the psychiatrist in charge believed that participants were able to co-operate. The nurses had been trained in assisting participants to work through the booklet and in answering any requests for information. Within the decision aid, participants were asked to write down their experiences with previous antipsychotic medications and to indicate their preferences on each topic regarding the available options. Participants met with their physicians within 24 hours after working through the decision aid with their nurse so they could reach an agreement with the psychiatrist on further treatment according to the preferences indicated by the participant in the booklet. Target of the intervention: nurses and doctors.

2. Routine care.


OutcomesGlobal state: PANSS.

Satisfaction with treatment: ZUF8.

Drug attitude: DAI.


NotesMean number of participants per cluster (m): 8.9.

Intraclass coefficient (ICC): not reported.

Design effect: 1.79.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationUnclear riskQuote: "Randomization was done at the level of the wards to avoid intervention and control conditions being confounded".

Quote: "Selection of the wards was made so as to ensure that there were six pairs of wards, with one member of each pair being randomly assigned to the control or to the interventional condition".

Allocation concealmentUnclear riskNo details reported.

Blinding
All outcomes
Unclear riskNo blinding.

Incomplete outcome data addressed
All outcomes
High riskAt follow-up (18 months), data were available for 66% of the initial sample.

Free of selective reportingLow riskAll study measures reported in the Methods were included in the analysis and reported in the Results.

Free of other biasUnclear riskAt baseline, the two groups were not perfectly balanced in terms of length of hospitalisation and psychopathology ratings. The trial was funded by the German Ministry of Health and Social Security (217-43794-5/9) within the funding project Der Patient als Partner im medizinischen Entscheidungsprozess.

Hudson 2008

MethodsAllocation: cluster-randomised trial.

Blindness: not blind.

Duration: six months.


ParticipantsDiagnosis: schizophrenia.

N of clusters: six Veterans Affairs Medical Centers (VAMCs).

N of participants: 349.

Sex: 93% M (experimental group); 95% M (control group).

Mean age, years: 45.4 (experimental group); 46.8 (control group).

Setting: USA.


Interventions1. Intervention to promote medication adherence. Research nurses were instructed to follow a written protocol for the intervention and conducted a clinical interview lasting 20 to 60 minutes. During this interview, the nurse completed a checklist of nine domains of barriers to adherence, derived from an extensive literature review. Based on the barriers identified, the nurse worked with participants to select and tailor strategies that could be used to overcome that particular barrier. The nurse conducted barrier assessments at entry into the study and at each subsequent visit; for individuals who did not have mental health appointments more frequent than every six weeks, the nurse attempted to contact the study participant to conduct a barrier assessment a minimum of every six weeks throughout the six-month study period. The nurse was given a detailed manual describing the intervention protocol, which included flexible scripts and suggestions to use in conducting clinical interviews with participants and assessment of medication adherence barriers. The protocol also specified how nurses were to maintain contact with participants during the study period and how nurse could provide feedback to each physician about the participant's treatment preferences, reported adherence and adherence barriers. Target of the intervention: nurses and participants.

2. Routine education about schizophrenia guidelines.


OutcomesTreatment (medication) adherence: participant's self-report of medication use over the previous 30 days and medical record abstraction for the participant's visit closest to baseline and follow-up dates.


NotesMean number of participants per cluster (m): 58.2.

Intraclass coefficient (ICC): not reported.

Design effect: 6.72.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationLow riskRandomisation was stratified by Veteran Integrated Service Network (VISN). In each VISN, two Veteran Affairs Medical Centers (VAMCs) were randomly assigned to experimental and control conditions (two clusters for each VISN). Quote: "One of the two VAMCs per VISN was randomly selected, using a random numbers table, to receive the enhanced implementation strategy, and the other site within each pair received a basic education strategy for schizophrenia guidelines".

Allocation concealmentUnclear riskNo details reported.

Blinding
All outcomes
Unclear riskNo blinding. A combination "self-report and provider assessment" strategy was employed to measure the primary outcomes (detection bias cannot be excluded, i.e. non-adherence might have been underestimated).

Incomplete outcome data addressed
All outcomes
Unclear riskOf 349 participants enrolled at the six VAMCs, 84% (N = 293) completed both baseline and six-month follow-up assessments. Quote: "Study participants lost to follow-up were more likely to be white (45% vs. 28%) and unmarried/separated (95% vs. 84%), but there were no other significant demographic differences between those who did or did not complete follow-up interviews".

Free of selective reportingLow riskAll study measures reported in the Methods were included in the analysis and reported in the Results.

Free of other biasUnclear riskAt baseline, the two groups were not perfectly balanced in terms of ethnic group and psychopathology rating. Funding was provided by a grant from the VA, J1SR& D (#CPG-97-027) and the VA South Central Mental Illness Research Education and Clinical Centre.

Osborn 2010

MethodsAllocation: cluster-randomised trial.

Blindness: not blind.

Duration: six months.


ParticipantsDiagnosis: schizophrenia and other severe mental disorders (schizoaffective disorder, bipolar disorder, persistent delusional disorder, non-organic chronic psychosis).

N of clusters: six community mental health teams (CMHTs).

N of participants: 121.

Sex: 66% M (experimental group); 55% M (control group).

Mean age, years: 42.0 (experimental group); 43.1 (control group).

Setting: Camden and Islington Mental Health and Social Care Trust, London.


Interventions1. Nurse-led intervention plus education pack. The intervention lasted six months and targeted improving the levels of recording of cardiovascular risk factors required to estimate 10-year cardiovascular risk. The nurse monitored whether cardiovascular screening had occurred and sent prompts to primary and secondary care staff if screening had not occurred. The nurse offered screening herself to cover participants who had not received the complete battery of cardiovascular risk factor screenings. Target of the intervention: nurses.

2. Education pack only: received copies of existing guidelines but no input by the nurse.


OutcomesPractitioner impact: screened for cardiovascular risk factors (blood pressure, cholesterol, glucose, BMI, smoking status, Framingham score), as reported by participants and from GP notes.


NotesMean number of participants per cluster (m): 20.2.

Intraclass coefficient (ICC): not reported.

Design effect: 2.92.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationLow riskQuote: "A statistician uninvolved in the trial randomly generated treatment allocation numbers".

Allocation concealmentLow riskQuote: "Participating CMHTs were randomly allocated to each arm of the trial using a sealed envelope method. Once two CMHTs in each geographical area had agreed to participate, the envelopes were opened to determine the allocation for each CMHT".

Blinding
All outcomes
Unclear riskQuote: "It was not possible for the researcher, the CMHT workers or the patients to remain blind to allocation. The researcher could not remain blind to which arm the CMHTs had been allocated to when she assessed satisfaction with the intervention and who had performed screening (GP, CMHT worker or nurse). Therefore, during the evaluation phase, the possibility of observer bias was decreased by obtaining information on the main outcome directly from primary care clinical notes".

Incomplete outcome data addressed
All outcomes
Low risk115 of 121 participants were included in follow-up assessments

Free of selective reportingLow riskAll study measures reported in the Methods were included in the analysis and reported in the Results.

Free of other biasLow riskAt baseline, the two groups were well balanced in terms of sociodemographic and clinical characteristics.

Funding: The study was funded by a Trial Platform grant from the UK Medical Research Council. Reference: G0301032.

Thompson 2008

MethodsAllocation: cluster-randomised trial.

Blindness: not blind.

Duration: five months.


ParticipantsDiagnosis: severe mental disorders.

N of clusters: 19 adult psychiatric units.

N of participants: 480.

Sex: 63.6% M (experimental group); 50.0% M (control group).

Mean age, years: 42.2 (experimental group); 42.4 (control group).

Setting: South-West England.


Interventions1. Multifaceted implementation strategy. The first phase of the implementation strategy involved a 30-minute structured personal visit to consultant psychiatrists by a specially trained clinical psychiatric pharmacist. The structure of the visit was based on the social marketing principles of 'academic-detailing'.. For the second part of the intervention, a workbook for both doctors and nurses was developed. This contained educational materials and specific cognitive techniques to challenge polypharmacy. The cognitive behavioural techniques were based on the principles of reducing risk-taking behaviours. The workbook was distributed to all ward doctors and nurses. A range of strategies were offered as alternatives to polypharmacy. A 'booster' pamphlet was sent eight weeks after distribution of the workbook. For the third part of the intervention, a medication chart reminder system was developed. Ward pharmacists applied removable reminder stickers to medication charts when participants were prescribed more than one antipsychotic. Target of the intervention: doctors and nurses.

2. Passive guideline dissemination: disseminated to all doctors and nurses.


OutcomesPractitioner impact: antipsychotic polypharmacy (from participants' medication charts).


NotesMean number of participants per cluster (m): 25.3.

Intraclass coefficient (ICC): 0.027.

Design effect: 1.65.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationLow riskRandom numbers were generated by one of the study authors using a calculator's random number generator function.

Allocation concealmentLow riskAllocation was performed by one of the study authors, who was blind to the identity of the units.

Blinding
All outcomes
Unclear riskQuote: "Participants were potentially aware of which group (control or intervention) they were allocated to due to the nature of the intervention".

Incomplete outcome data addressed
All outcomes
Low riskAll randomly assigned units (clusters) were included in the analysis. The study consisted of two cross-sectional surveys, one carried out at baseline and the second at follow-up. The primary outcome was polypharmacy at follow-up (cross-sectional nature of the primary outcome measure).

Free of selective reportingLow riskAll study measures reported in the Methods were included in the analysis and reported in the Results.

Free of other biasUnclear riskQuote: "Patients were younger, more likely to be male and detained under the Mental Health Act in the intervention arm".

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Azrin 1998Allocation: randomised.

Participants: included people with bipolar disorder and unipolar. depression, not schizophrenia.

Byng 2004Allocation: randomised.

Participants: included people with bipolar disorder, chronic. depressive or neurotic conditions, not schizophrenia.

Koivunen 2010Allocation: randomised.

Participants: people with schizophrenia.

Intervention: Web-based participant support system versus. standard care, not guideline implementation.

Michie 2005Allocation: randomised.

Participants: mental health service users, no details about diagnosis.

Intervention: behaviorally modified text from NICE guidelines versus original text.

Outcomes: cognitive predictors of behaviour measured with a non-validated questionnaire.

Rush 2003Allocation: not randomised; control clinics were matched with experimental clinics.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Olfson 1998

MethodsAllocation: cluster-randomised, outpatient clinics matched by sociodemographic composition of patients.

ParticipantsDiagnosis: schizophrenia.

N = unclear.

Interventions
  1. Medication algorithms: intensive guideline implementation intervention aimed at improving the short-term outcome of public sector participants with schizophrenia.
  2. Participant and family education.
  3. Clinical support.

OutcomesPsychiatric symptoms, adverse effects, adherence to prescribed medications, social and occupational functioning, quality of life, satisfaction with care, mental healthcare service utilisation: unclear how these were measured.

Notes

 
Characteristics of ongoing studies [ordered by study ID]
JPRN-UMIN000004931

Trial name or titleJPRN-UMIN000004931

MethodsAllocation: randomised.

ParticipantsDiagnosis: schizophrenia.

Interventions
  1. Algorithm-guided treatment.

OutcomesGlobal state: PANSS.

Starting date2009/08/01. Last refreshed on: 8 February 2011.

Contact informationMotoichiro Kato, Keio University Department of Neuropsychiatry, School of Medicine.

Notes

NCT00156637

Trial name or titleNCT00156637

MethodsAllocation: randomised.

Blinding: open.

ParticipantsDiagnosis: schizophrenia or schizoaffective disorder.

Interventions
  1. Behavioural: team-based quality improvement.
  2. Behavioural: opinion leader.

OutcomesAntipsychotic dose above guideline-recommended range.

Starting dateStudy start: June 2005; Study completion: May 2008.

Contact informationRichard R. Owen, MD, Principal Investigator, Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock, USA.

Notes

NCT00182494

Trial name or titleNCT00182494

MethodsAllocation: randomised.

Blinding: double.

ParticipantsDiagnosis: schizophrenia.

Interventions
  1. Behaviour: modified diabetes prevention protocol and metformin.

OutcomesIncidence of new-onset diabetes.

Starting dateStudy start: February 2005; expected completion: July 2009.

Last follow-up: January 2009; data entry closure: April 2009.

Contact informationLakshmi P Voruganti, MD, Principal Investigator, Hamilton Health Sciences, Ontario, Canada.

Notes

NCT00541398

Trial name or titleNCT00541398

MethodsAllocation: randomised.

Blindness: open.

ParticipantsDiagnosis: schizophrenia.

Interventions
  1. Behavioral: implementation of guideline (educational intervention).
  2. No intervention.

OutcomesPractitioner effects: antipsychotic polypharmacy.

Starting dateStudy start date: January 2008.
Estimated completion date: January 2010.
Estimated primary completion date: January 2009 (final data collection date for primary outcome measure).

Contact informationBirte Glenthøj, Professor, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen.

Notes

 
Comparison 1. Active education + Support for implementation guidelines versus Routine care or Passive dissemination

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

 1 Practitioner (process) outcomes: Impact: 1. Polypharmacy at follow-up2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Uncorrected
21082Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.99, 1.23]

    1.2 Corrected for design effect
2310Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.75, 1.25]

 2 Practitioner (process) outcomes: Impact: 2. Not screened for cardiovascular risk factors1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    2.1 Blood pressure—uncorrected
196Risk Ratio (M-H, Random, 95% CI)0.07 [0.02, 0.28]

    2.2 Blood pressure—corrected for design effect
133Risk Ratio (M-H, Random, 95% CI)0.10 [0.01, 0.74]

    2.3 Cholesterol—uncorrected
1103Risk Ratio (M-H, Random, 95% CI)0.46 [0.30, 0.70]

    2.4 Cholesterol—corrected for design effect
135Risk Ratio (M-H, Random, 95% CI)0.49 [0.24, 0.99]

    2.5 Glucose—uncorrected
1103Risk Ratio (M-H, Random, 95% CI)0.53 [0.34, 0.82]

    2.6 Glucose—corrected for design effect
135Risk Ratio (M-H, Random, 95% CI)0.58 [0.28, 1.21]

    2.7 BMI—uncorrected
199Risk Ratio (M-H, Random, 95% CI)0.22 [0.08, 0.60]

    2.8 BMI—corrected for design effect
134Risk Ratio (M-H, Random, 95% CI)0.18 [0.02, 1.37]

    2.9 Smoking status—uncorrected
196Risk Ratio (M-H, Random, 95% CI)0.28 [0.12, 0.64]

    2.10 Smoking status—corrected for design effect
132Risk Ratio (M-H, Random, 95% CI)0.25 [0.06, 1.03]

    2.11 Framingham score—uncorrected
1110Risk Ratio (M-H, Random, 95% CI)0.69 [0.55, 0.87]

    2.12 Framingham score—corrected for design effect
138Risk Ratio (M-H, Random, 95% CI)0.71 [0.48, 1.03]

 3 Patient outcomes: global state: average score (PANSS total, high = poor)1Mean Difference (IV, Random, 95% CI)Subtotals only

    3.1 Uncorrected
1105Mean Difference (IV, Random, 95% CI)-1.30 [-8.21, 5.61]

    3.2 Corrected for design effect
159Mean Difference (IV, Random, 95% CI)-1.30 [-10.52, 7.92]

 4 Patient outcomes: satisfaction with care: average score (ZUF8, high = better satisfaction)1Mean Difference (IV, Random, 95% CI)Subtotals only

    4.1 Uncorrected
183Mean Difference (IV, Random, 95% CI)0.10 [-1.43, 1.63]

    4.2 Corrected for design effect
146Mean Difference (IV, Random, 95% CI)0.10 [-1.96, 2.16]

 5 Patient outcomes: treatment adherence: not adherent at follow-up1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    5.1 Uncorrected
1349Risk Ratio (M-H, Random, 95% CI)0.87 [0.66, 1.15]

    5.2 Corrected for design effect
152Risk Ratio (M-H, Random, 95% CI)0.9 [0.44, 1.85]

 6 Patient outcomes: drug attitude: average score (DAI, high = positive attitude)1Mean Difference (IV, Random, 95% CI)Subtotals only

    6.1 Uncorrected
157Mean Difference (IV, Random, 95% CI)-1.40 [-2.88, 0.08]

    6.2 Corrected for design effect
132Mean Difference (IV, Random, 95% CI)-1.40 [-3.38, 0.58]

 
Summary of findings for the main comparison. Active education + Support for implementation compared with Routine care or Passive dissemination for participants with schizophrenia and related psychosis

Active education + Support for implementation compared with Routine care or Passive dissemination for participants with schizophrenia and related psychosis

Patient or population: participants with schizophrenia and related psychosis
Settings: specialist mental health care
Intervention: Active education + Support for implementation
Comparison: Routine care or Passive dissemination

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Routine care or Passive disseminationActive education + Support for implementation

Polypharmacy at follow-up441 per 1,000428 per 1,000
(331 to 552)
RR 0.97
(0.75 to 1.25)
310
(two studies)
⊕⊝⊝⊝
very low1,2

Not screened for cardiovascular risk factors895 per 1,000635 per 1,000
(429 to 922)
RR 0.71
(0.48 to 1.03)
38
(one study)
⊕⊝⊝⊝
very low1,3

Global statePANSS total scoreMean global state—PANSS total score—design effect corrected in the intervention groups was
01.30 lower
(10.52 lower to 7.92 higher)
59
(one study)
⊕⊝⊝⊝
very low4,5

Satisfaction with careZUF8Mean satisfaction with care—ZUF8—design effect corrected in the intervention groups was
0.10 higher
(1.96 lower to 2.16 higher)
46
(one study)
⊕⊝⊝⊝
very low4,5

Lack of treatment adherencedesign effect corrected385 per 1,000346 per 1,000
(169 to 712)
RR 0.90
(0.44 to 1.85)
52
(one study)
⊕⊝⊝⊝
very low5,6

Drug attitudeDAIMean drug attitude—DAI—design effect corrected in the intervention groups was
1.40 lower
(3.38 lower to 0.58 higher)
32
(one study)
⊕⊝⊝⊝
very low4,5

Quality of lifeMean quality of life—design effect corrected in the intervention groups was
0 higher
(0 to 0 higher)
Not estimable0
(0)
See commentNo trial reported this outcome

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Risk of bias: rated—'very serious'—Randomisation and allocation poorly described.
2Imprecision: rated—'serious'—Only two studies with a pooled treatment estimate ranging from substantial beneficial effect to substantial harmful effect.
3Imprecision: rated—'serious'—Only one study with few cases and events.
4Risk of bias: rated—'serious'—Groups were not well balanced in terms of length of hospitalisation and psychopathology ratings.
5Imprecision: rated—'very serious'—Only one study with few cases.
6Risk of bias: rated—'serious'—Groups were not well balanced in terms of ethnic groups and psychopathology ratings.
 
Table 1. Suggested schizophrenia reviews into which excluded randomised studies could be used

Excluded study tagComparisonExisting Cochrane review

Koivunen 2010Web-based participant support systems for people with schizophrenia.Välimäki 2012

 
Table 2. Suggested design for future trial

MethodsAllocation: random allocation—As the intervention naturally occurs in groups of individuals, the unit of random allocation may be the group, or cluster, rather than the individual.

Concealment of cluster allocation status: Participant recruitment may be carried out by professionals who are masked to the cluster allocation status.

Blinding: Outcome assessors should not be involved in the conduct of the study and may be masked to the allocated interventions.

ParticipantsDiagnosis: people with schizophrenia or related psychosis (clinicians' implicit criteria)

Sample size: depends on number of clusters, average cluster size and degree of correlation within clusters (intracluster correlation coefficient, ICC).

Interventions
  1. Guideline implementation strategy.
  2. Passive dissemination.

OutcomesPrimary outcomes: practitioner impact (this measure would differ according to the characteristics and purposes of the guideline under trial); participant impact (global state, this measure would differ according to the characteristics and purposes of the guideline under trial).

Secondary outcomes: treatment adherence, satisfaction with care, drug attitude and quality of life.

NoteCluster trials should report design effect and ICC.