Cochrane Handbook for Systematic Reviews of Interventions
Published 22 September 2008
Citations24,936
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Abstract
The Cochrane Handbook for Systematic Reviews of Interventions is the official document that describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions.
Keywords
Decision SciencesMedicineHealth Professions
Controlled Clinical TrialsAssessing the quality of reports of randomized clinical trials: Is blinding necessary?
17,565 Citations1996Alejandro R. Jadad, R Andrew Moore +5 more
An instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research is described and its use to determine the effect of rater blinding on the assessments of quality is described.
JAMAEmpirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials
5,580 Citations1995Klaus‐Peter Schulz
Empirical evidence is provided that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias.
The LancetThe CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
5,372 Citations2001David Moher, Kenneth F. Schulz +1 more
The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
The LancetDoes quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?
3,591 Citations1998David Moher, Ba’ Pham +6 more
Study of low methodological quality in which the estimate of quality is incorporated into the meta-analyses can alter the interpretation of the benefit of intervention, whether a scale or component approach is used in the assessment of trial quality.
BMJAssessing the quality of controlled clinical trials
3,334 Citations2001Peter Jüni, Douglas G Altman +1 more
The concept of study quality and the methods used to assess quality are discussed and the methodology for both the assessment of quality and its incorporation into systematic reviews and meta-analysis is discussed.
BMC Medical Research MethodologyThe CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
2,754 Citations2001David Moher, Kenneth F. Schulz +1 more
The revised CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
Annals of Internal MedicineReported Methodologic Quality and Discrepancies between Large and Small Randomized Trials in Meta-Analyses
2,326 Citations2001Lise Lotte Kjaergard, John Villumsen +1 more
The potential association between reported methodologic quality and intervention effects was studied to assess whether methodologicquality may explain discrepancies between the results of large and small randomized trials in meta-analyses.
International Journal of EpidemiologyMeta-analyses involving cross-over trials: methodological issues
2,294 Citations2002Diana R Elbourne, Douglas G. Altman +4 more
Methods do exist for including valuable information from two-period, two-treatment cross-over trials into quantitative reviews, however, poor reporting of cross- over trials will often impede attempts to perform a meta-analysis using the available methods.
BMJWhat is meant by intention to treat analysis? Survey of published randomised controlled trials
2,130 Citations1999S. Hollis, Fiona Campbell
Assessment of reports of randomised controlled trials published in 1997 found that intention to treat was used, but handling of deviations from randomised allocation varied widely and methods used to deal with this were generally inadequate, potentially leading to bias.
The LancetEffect of angiotensin-converting-enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPPP) randomised trial
2,009 Citations1999Lennart Hansson, Lars Lindholm +11 more
Captopril and conventional treatment did not differ in efficacy in preventing cardiovascular morbidity and mortality and the difference in stroke risk was probably due to the lower levels of blood pressure obtained initially in previously treated patients randomised to conventional therapy.
JAMAThe Hazards of Scoring the Quality of Clinical Trials for Meta-analysis
1,983 Citations1999Peter Jüni
The data indicate that the use of summary scores to identify trials of high quality is problematic, and relevant methodological aspects should be assessed individually and their influence on effect sizes explored.
JAMAEmpirical Evidence for Selective Reporting of Outcomes in Randomized Trials
1,806 Citations2004An‐Wen Chan, Asbjørn Hróbjartsson +3 more
The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.
Controlled Clinical TrialsAssessing the quality of randomized controlled trials: An annotated bibliography of scales and checklists
1,304 Citations1995David Moher, Alejandro R. Jadad +4 more
An annotated bibliography of scales and checklists developed to assess quality is presented, giving readers a quantitative index of the likelihood that the reported methodology and results are free of bias.
Health Technology AssessmentHow important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study
1,169 Citations2003Matthias Egger, Peter Jüni +3 more
The LancetLow-dose aspirin and vitamin E in people at cardiovascular risk: a randomised trial in general Practice
996 Citations2001Maria Carla Roncaglioni
In women and men at risk of having a cardiovascular event because of the presence of at least one major risk factor, low-dose aspirin given in addition to treatment of specific risk factors contributes an additional preventive effect, with an acceptable safety profile.
The LancetLow-dose dopamine in patients with early renal dysfunction: a placebo-controlled randomised trial
994 Citations2000Rinaldo Bellomo, Marianne J. Chapman +3 more
Administration of low-dose dopamine by continuous intravenous infusion to critically ill patients at risk of renal failure does not confer clinically significant protection from renal dysfunction.
The LancetEffect of aggressive versus conventional lipid lowering on atherosclerosis progression in familial hypercholesterolemia (ASAP): a prospective, randomised, double-blind trial
920 Citations2001TJ Smilde, Sanne van Wissen +4 more
The results show that aggressive LDL-cholesterol reduction by atorvastatin was accompanied by regression of carotid intima media thickness in patients with familial hypercholesterolaemia, whereas conventional LDL lowering was not.
The LancetAllocation concealment in randomised trials: defending against deciphering
904 Citations2002Kenneth F. Schulz, David A. Grimes
Investigators must effectively immunise trials against selection and confounding biases with proper allocation concealment, andHypothesis tests of baseline characteristics, however, are superfluous and could be harmful if they lead investigators to suppress reporting any baseline imbalances.
The British Journal of PsychiatryUnpublished rating scales: A major source of bias in randomised controlled trials of treatments for schizophrenia
868 Citations2000Max Marshall, Austin Lockwood +4 more
Unpublished scales are a source of bias in schizophrenia trials and in non-pharmacological trials, one-third of ‘gold-standard’ claims of treatment superiority would not have been made if published scales had been used.
The LancetGeneration of allocation sequences in randomised trials: chance, not choice
737 Citations2002Kenneth F. Schulz, David A. Grimes
BMJForest plots: trying to see the wood and the trees
735 Citations2001Steff Lewis, Mike Clarke
Few systematic reviews containing meta-analyses are complete without a forest plot, which shows the amount of variation between the studies and an estimate of the overall result.
PubMedRandomized trials stopped early for benefit: a systematic review.
696 Citations2005Víctor M. Montori, P.J. Devereaux +20 more
RCTs stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small, which suggests clinicians should view the results of such trials with skepticism.
BMJPost-randomisation exclusions: the intention to treat principle and excluding patients from analysis
694 Citations2002Dean Fergusson, Shawn D Aaron +2 more
The authors consider the circumstances when it may be possible to exclude patients from the analysis of data in clinical trials, even in an intention to treat trial.
Controlled Clinical TrialsStatistical Considerations in the Intent-to-Treat Principle
658 Citations2000John M. Lachin
This paper describes some of the statistical considerations in the intent-to-treat design and analysis of clinical trials and describes the potential bias that can be introduced by such postrandomization exclusions and the pursuant effects on type I error probabilities.
Journal of Clinical EpidemiologyIncorporating variations in the quality of individual randomized trials into meta-analysis
646 Citations1992Allan S. Detsky, C. David Naylor +3 more
It is concluded that while it is possible to incorporate the effect of variation of quality of individual trials into overviews, this issue requires more study.
BMJEvidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications
639 Citations2003Hans Melander, Jane Ahlqvist-Rastad +2 more
Any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.
BMJIdentifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors
611 Citations2005An‐Wen Chan, Douglas G. Altman
Incomplete reporting of outcomes within published articles of randomised trials is common and is associated with statistical non-significance, the medical literature represents a selective and biased subset of study outcomes, and trial protocols should be made publicly available.
The LancetSputum eosinophilia and short-term response to prednisolone in chronic obstructive pulmonary disease: a randomised controlled trial
590 Citations2000Christopher E. Brightling, William Monteiro +5 more
It is suggested that eosinophilic airway inflammation contributes to airflow obstruction and symptoms in some patients with COPD and that the short-term effects of prednisolone are due to modification of this feature of the inflammatory response.
Clinical TrialsAre missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals
557 Citations2004Angela Wood, Ian R. White +1 more
It is shown that missing outcome data are a common problem in randomized controlled trials, and are often inadequately handled in the statistical analysis in the top tier medical journals.
BMC Medical Research MethodologyThe use of percentage change from baseline as an outcome in a controlled trial is statistically inefficient: a simulation study
542 Citations2001Andrew J. Vickers
Percentage change from baseline should not be used in statistical analysis and trialists wishing to report this statistic should use another method, such as ANCOVA, and convert the results to a percentage change by using mean baseline scores.
JAMASubverting Randomization in Controlled Trials
477 Citations1995Kenneth F. Schulz
Anonymous accounts run the gamut from simple to intricate operations, from transillumination of envelopes to searching for code in the office files of the principal investigator, indicating that deciphering is something more frequent than a rate occurrence.
JAMACorrelation of Quality Measures With Estimates of Treatment Effect in Meta-analyses of Randomized Controlled Trials
475 Citations2002Ethan M. Balk
Individual quality measures are not reliably associated with the strength of treatment effect across studies and medical areas, and findings of associations with treatment effect cannot be generalized to all clinical areas or meta-analyses.
Canadian Medical Association JournalOutcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research
446 Citations2004A.-W. Chan
Whether outcome reporting bias would be present in a cohort of government-funded trials subjected to rigorous peer review and whether primary outcomes specified in trial protocols were compared with those reported in publications is compared.
International Journal of Technology Assessment in Health CareAssessing the Quality of Randomized Controlled Trials:<i>Current Issues and Future Directions</i>
441 Citations1996David Moher, Alejandro R. Jadad +1 more
Assessing the quality of randomized controlled trials is a relatively new and important development, and several methods for including quality scores in systematic reviews have been proposed, but since little empirical evidence supports any given method, results must be interpreted cautiously.
Statistics in MedicineStatistical methods for assessing the influence of study characteristics on treatment effects in ‘meta‐epidemiological’ research
390 Citations2002Jonathan A C Sterne, Peter Jüni +4 more
It is shown that both within- and between meta-analysis heterogeneity may be of importance in the analysis of meta-epidemiological studies, and that confounding exists between the effects of publication status and trial quality.
Statistics in MedicineHeterogeneity and statistical significance in meta-analysis: an empirical study of 125 meta-analyses
363 Citations2000Eric A. Engels, Christopher H. Schmid +3 more
This work studied 125 meta-analyses representative of those performed by clinical investigators to examine empirically how assessment of treatment effect and heterogeneity may differ when different methods are utilized, and presents two exceptions to these observations.
BMJEvidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals
362 Citations2003Suezann Puffer, David Torgerson +1 more
Examination of cluster randomised controlled trials published in the BMJ, Lancet, and New England Journal of Medicine from January 1997 to October 2002 found some recently published studies may not have taken adequate precautions to guard against threats to the internal validity of their design.
BiostatisticsOn the bias produced by quality scores in meta-analysis, and a hierarchical view of proposed solutions
357 Citations2001Sander Greenland
It is argued that response-surface estimation based on quality items is preferable to quality weighting, because it is unlikely that a low-dimensional appraisal will ever be adequate (especially over different applications), and because quality scores are often used to contrast, model, or modify meta-analysis results.
NeurologyThe impact of blinding on the results of a randomized, placebo‐controlled multiple sclerosis clinical trial
335 Citations1994John H. Noseworthy, George C. Ebers +4 more
There were no significant differences in the time to treatment failure or in the proportions of patients improved, stable, or worse between the group II and group III patients who correctly guessed their treatment assignments and those who did not.
BMC Medical Research MethodologyMethodological bias in cluster randomised trials
313 Citations2005Seokyung Hahn, Suezann Puffer +2 more
Clinical TrialsLessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care
297 Citations2004Sandra Eldridge, Deborah Ashby +3 more
Methodologic quality of cluster randomized trials in primary health care is variable and reporting needs improvement, and the use of cluster randomization should be indicated in the title or abstract so these kinds of trials are easier to identify.
JAMAAnalysis and Reporting of Factorial Trials
284 Citations2003Finlay A. McAlister, Sharon E. Straus +2 more
The findings suggest that investigators are appropriately restricting their use of the factorial design to those situations in which 2 (or more) treatments do not have the potential for substantive interaction.
Statistics in MedicineThe performance of the two‐stage analysis of two‐treatment, two‐period crossover trials
275 Citations1989P. R. Freeman
It is concluded that the two-stage analysis for analysing the data from a two-treatment, two-period crossover trial is too potentially misleading to be of practical use.
JAMAPhysician Interpretations and Textbook Definitions of Blinding Terminology in Randomized Controlled Trials
258 Citations2001P.J. Devereaux
It is suggested that both physicians and textbooks vary greatly in their interpretations and definitions of single, double, and triple blinding.
Statistics in MedicineIntention‐to‐treat: methods for dealing with missing values in clinical trials of progressively deteriorating diseases
257 Citations2001Kristina Unnebrink, Jürgen Windeler
This work performed a detailed investigation of different methods for dealing with missing values in order to develop recommendations for their practical use and investigates possible consequences on type I error and power of applying different methods.
The LancetUnequal group sizes in randomised trials: guarding against guessing
249 Citations2002Kenneth F. Schulz, David A. Grimes
Controlled Clinical TrialsAn empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials
246 Citations1990John D. Emerson, Elisabeth Burdick +3 more
In an empirical study of the relation of quality scores to treatment differences in published meta-analyses of 7 groups of controlled randomized clinical trials comprising 107 primary studies, it is found no relation between treatment difference and overall quality score.
Annals of Internal MedicineThe Landscape and Lexicon of Blinding in Randomized Trials
244 Citations2002Kenneth F. Schulz, Iain Chalmers +1 more
The landscape and lexicon of blinding in randomized trials in the hope of untangling some of that terminology, which is widely recognized as reducing differential assessment of outcomes of interest.
Statistics in MedicineBayesian approaches to multiple sources of evidence and uncertainty in complex cost‐effectiveness modelling
235 Citations2003David J. Spiegelhalter, Nicola Best
The multiple sources of uncertainty that are relevant to such models, and their relation to either probabilistic or deterministic sensitivity analysis are described, and a Bayesian approach appears natural in this context.
JAMAData Extraction Errors in Meta-analyses That Use Standardized Mean Differences
230 Citations2007Peter C Gøtzsche, Asbjørn Hróbjartsson +2 more
The high proportion of meta-analyses based on SMDs that show errors indicates that although the statistical process is ostensibly simple, data extraction is particularly liable to errors that can negate or even reverse the findings of the study.
International Journal of EpidemiologyInvestigating patient exclusion bias in meta-analysis
213 Citations2004Jayne F. Tierney
Trial, systematic reviews, and meta-analyses may be prone to bias associated with post-randomization exclusion of patients, and wherever possible, the level of such exclusions should be taken into account when assessing the potential for bias.
BMJMeta-analysis and the meta-epidemiology of clinical research
210 Citations1997C. David Naylor
This week's BMJ contains a pot-pourri of materials that deal with the research methodology of meta-analysis, with many studies have documented publication bias favouring clinical trials that show a significant treatment effect.
Journal of the Royal Statistical Society Series C (Applied Statistics)Bias in Meta-Analysis Due to Outcome Variable Selection Within Studies
200 Citations2000Jane L. Hutton, Paula Williamson
The sensitivity analyses show that the robustness of the anthelminth results is dependent on what assumption one makes about the reporting strategy for the largest trial, and the effect of a mild assumption on within‐trial selection alone could alter general recommendations about the treatment for incontinence.
Statistics in MedicineMinimizing predictability while retaining balance through the use of less restrictive randomization procedures
198 Citations2003Vance W. Berger, Anastasia Ivanova +1 more
The maximal procedure takes as input the extent of chronological bias allowed by the randomized block procedure, then matches it, but does so with fewer restrictions, which makes the maximal procedure more resistant to selection bias than the randomized blocks procedure is.
Statistical Methods in Medical ResearchOutcome selection bias in meta-analysis
192 Citations2005Paula Williamson, Carrol Gamble +2 more
It is recommended that both publication bias and selective reporting should be routinely investigated in systematic review, and how common is within-study selective reporting?
Journal of Clinical EpidemiologyIn the dark The reporting of blinding status in randomized controlled trials
176 Citations2002Víctor M. Montori, Mohit Bhandari +4 more
In conclusion, prestigious journals should abandon the term "double blind" and explicitly report the blinding status of the groups involved in RCTs, and clinicians will be left with uncertainty about the validity of R CTs that guide their clinical practice.
Journal of Clinical EpidemiologyDiscordance between reported intention-to-treat and per protocol analyses
174 Citations2007Núria Porta, Catalina Bonet +1 more
It is confirmed that missing values may cause both systematic and unpredictable bias in CTs and further efforts should be made to minimize protocol deviations and to use better statistical methods to highlight the drawbacks of missing information.
PLoS MedicineMethods of Blinding in Reports of Randomized Controlled Trials Assessing Pharmacologic Treatments: A Systematic Review
155 Citations2006Isabelle Boutron, Candice Estellat +5 more
A systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register provided a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmalogic trials.
Journal of the Society for Integrative OncologyHow to Randomize
146 Citations2006Andrew J. Vickers
The purpose of randomization is to prevent selection bias, and randomization procedures must ensure that researchers are unable to predict the group to which a patient will be randomized until the patient is unambiguously registered on study.
Statistics in MedicineIdentification and impact of outcome selection bias in meta‐analysis
134 Citations2004Paula Williamson, Carrol Gamble
The systematic review community has become increasingly aware of the importance of addressing the issues of heterogeneity and publication bias in meta‐analyses and the within‐study selective reporting of outcomes, defined as the selection of a subset of the original variables recorded for inclusion in publication of trials.
Cochrane Database of Systematic ReviewsCompression stockings for preventing deep vein thrombosis in airline passengers
134 Citations2016Mike Clarke, Cathryn Broderick +3 more
There is high-quality evidence that airline passengers similar to those in this review can expect a substantial reduction in the incidence of symptomless DVT and low- quality evidence that leg oedema is reduced if they wear compression stockings.
BMJClustering by health professional in individually randomised trials
124 Citations2005Katherine J. Lee, Simon G. Thompson
The prevalence and importance of potential clustering in individually randomised trials is examined and an example of the effect it can have on the overall results and conclusions of a trial is presented.
Fertility and SterilityEmpirical evidence of bias in infertility research: overestimation of treatment effect in crossover trials using pregnancy as the outcome measure
114 Citations1996Khalid S. Khan, Salim Daya +2 more
The use of a crossover design for evaluating infertility treatments with outcomes that prevent patients from completing later phases of the trial should be avoided because it leads to exaggerated estimates of treatment effect and may result in erroneous inferences and clinical decisions.
Biometrical JournalQuantifying the Magnitude of Baseline Covariate Imbalances Resulting from Selection Bias in Randomized Clinical Trials
113 Citations2005Vance W. Berger
The purpose is to quantify the magnitude of baseline imbalance that can result from third‐order selection bias when the randomized block procedure is used, and it is found that a binary covariate can, on average, be up to 50% unbalanced by third‐ order selection bias.
JAMAAssociation Between Unreported Outcomes and Effect Size Estimates in Cochrane Meta-analyses
113 Citations2007Toshi A. Furukawa, Norio Watanabe +3 more
Journal of Evaluation in Clinical PracticeInvestigation of within‐study selective reporting in clinical research: follow‐up of applications submitted to a local research ethics committee
102 Citations2002Seokyung Hahn, Paula Williamson +1 more
The pilot study has shown that within-study selective reporting may be examined qualitatively by comparing the study report with the study protocol, and suggests that it might well be substantial.
Statistics in MedicineMinimization—reducing predictability for multi‐centre trials whilst retaining balance within centre
101 Citations2005Sarah Brown, H. Thorpe +2 more
It is suggested that minimization can still be used, and that centre can be included as a stratification factor, but a random element has to be incorporated into the minimization algorithm.
Journal of Clinical EpidemiologyA review of blinding in randomized controlled trials found results inconsistent and questionable
89 Citations2005Isabelle Boutron, Candice Estellat +1 more
Methods of assessing the success of blinding, analysis and reporting the results were inconsistent and questionable.
JAMAConstraints on Publication Rights in Industry-Initiated Clinical Trials
79 Citations2006Peter C Gøtzsche, Asbjørn Hróbjartsson +4 more
Clinical TrialsDifferential recruitment in a cluster randomized trial in primary care: the experience of the UK Back pain, Exercise, Active management and Manipulation (UK BEAM) feasibility study
79 Citations2005Amanda Farrin, Ian Russell +2 more
The dangers of randomizing entire primary care practices when participants cannot be identified before randomization are reported, as shown by a UK national trial.
Cochrane Database of Systematic ReviewsAmphotericin B lipid soluble formulations versus amphotericin B in cancer patients with neutropenia
74 Citations2014Helle Krogh Johansen, Peter C Gøtzsche
It is not clear whether there are any advantages of lipid-based formulations if conventional amphotericin B is administered under optimal circumstances, and their high cost prohibits routine use in most settings.
The LancetMega-trials and management of acute myocardial infarction
72 Citations1995KL Woods
These issues are illustrated by the examples of nitrates, angiotensin-converting-enzyme inhibitors, and magnesium in acute myocardial infarction but have general relevance to the validity and generalisability of simple trials.
Obesity ResearchSix‐Month Treatment of Obesity with Sibutramine 15 mg; A Double‐Blind, Placebo‐Controlled Monocenter Clinical Trial in a Hispanic Population
69 Citations2000Guillermina Elisa Martínez Cuellar, A. Martínez Ruiz +2 more
The results show that sibutramine induces significant loss of body weight and waist circumference and Cardiovascular function was not significantly affected by sibUTramine.
Journal of Clinical EpidemiologySystematic reviewers neglect bias that results from trials stopped early for benefit
61 Citations2007Dirk Bassler, Ignacio Ferreira‐González +10 more
Most systematic reviews and meta-analyses including tRCTs fail to consider the possible overestimates of effect that may result from early stopping for benefit, and are recommended to address this possibility.
Cochrane Database of Systematic ReviewsVoriconazole versus amphotericin B in cancer patients with neutropenia
42 Citations2006Karsten Juhl Jørgensen, Peter C Gøtzsche +1 more
Liposomal amphotericin B is significantly more effective than voriconazole for empirical therapy of neutropenic cancer patients and should be preferred, and for treatment of aspergillosis, there are no trials that have compared vorIconazole with amphoteric in B given under optimal conditions.
TrialsFlaws in design, analysis and interpretation of Pfizer's antifungal trials of voriconazole and uncritical subsequent quotations
17 Citations2006Karsten Juhl Jørgensen, Helle Krogh Johansen +1 more
It is suggested that editors ensure that the abstract reflects fairly on the remainder of the paper, and that journals do not impose any time limit for accepting letters that point out serious weaknesses in a study that have not been noted before.
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