Assessing the quality of controlled clinical trials
BMJPublished 7 July 2001Open access
Peter Jüni, Douglas G Altman, Matthias Egger
Citations3,334
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
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.
Keywords
Decision SciencesMedicineHealth Professions
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 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.
JAMAThe CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials
2,530 Citations2001David Moher
The revised CONSORT statement presented in this paper 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.
Systematic Reviews in Health Care : Meta-Analysis in Context
2,321 Citations2000Matthias Egger, George Davey Smith +1 more
The second edition of this best-selling book has been thoroughly revised and expanded to reflect the significant changes and advances made in systematic reviewing.
Borås Academic Digital Archive (University of Borås)Indications for fibrinolytic therapy in suspected acute myocardial infarction : collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients
2,230 Citations1994Johan Herlitz
It is shown that fibrinolytic therapy can reduce mortality in patients with suspected acute myocardial infarction (AMI) and the indications for, and contraindications to, this therapy.
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.
BMJInvestigating and dealing with publication and other biases in meta-analysis
2,126 Citations2001Jonathan A C Sterne, Matthias Egger +1 more
Asymmetrical funnel plots may indicate publication bias or be due to exaggeration of treatment effects in small studies of low quality; funnel plots should be seen as a means of examining “small study effects” rather than a tool for diagnosing specific types of bias.
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.
Controlled Clinical TrialsA method for assessing the quality of a randomized control trial
1,370 Citations1981Thomas C. Chalmers, Harry Smith +5 more
A reasonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.
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.
Psychological BulletinFactors relevant to the validity of experiments in social settings.
1,127 Citations1957Donald T. Campbell
JAMAUse of the CONSORT Statement and Quality of Reports of Randomized Trials
1,018 Citations2001David Moher, Alison Jones +2 more
Use of the Consolidated Standards for Reporting of Trials (CONSORT) statement is associated with improvements in the quality of reports of RCTs.
New England Journal of MedicineInfluence of Adherence to Treatment and Response of Cholesterol on Mortality in the Coronary Drug Project
656 Citations1980The Coronary Drug Project Research Group
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.
The LancetAntihypertensive drugs in very old people: a subgroup meta-analysis of randomised controlled trials
630 Citations1999François Gueyffier, Christopher J. Bulpitt +7 more
Results of a large-scale specific trial are needed for definite conclusion that antihypertensive treatment is beneficial in very elderly hypertensive patients, as an age threshold beyond which hypertension should not be treated cannot be justified.
BMJCommunication behaviours in a hospital setting: an observational study
492 Citations1998Enrico Coiera, V. Tombs
It is concluded that hospital staff may need instruction in appropriate use of communication facilities and that some communication technology—voicemail and email with acknowledgment, cellular telephones for mobile communication, improved support for role based contact, and message screening—may be beneficial in the hospital environment.
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.
New England Journal of MedicineControversy in Counting and Attributing Events in Clinical Trials
411 Citations1979David L. Sackett, Michael Gent
An attempt is made to establish a procedure to estimate the number of events in a randomized clinical trial and to determine which treatment should be blamed for these events.
Health Technology AssessmentAssessing the quality of reports of randomised trials: implications for the conduct of meta-analyses.
368 Citations1999Moher, Cook +6 more
This work aims to provide a database of systematic reviews of systematic Reviews of Pediatrics and Biostatistics for use in clinical practice and aims to rank the reviews according to their quality and adequacy.
BMJStatistics notes: Treatment allocation in controlled trials: why randomise?
349 Citations1999Douglas G. Altman, John M. Bland
Journal of Clinical EpidemiologyMeta-analysis: Statistical alchemy for the 21st century
339 Citations1995Alvan R. Feinstein
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.
JAMAValue of Flow Diagrams in Reports of Randomized Controlled Trials
310 Citations2001Matthias Egger
Flow diagrams are associated with improved quality of reporting of randomized controlled trials, and the structure of current flow diagrams is less than ideal, so a revised flow diagram is proposed that includes all important counts through the stages of parallel group trials.
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.
Journal of Clinical EpidemiologyImpact of Study Quality on Outcome in Placebo-Controlled Trials of Homeopathy
210 Citations1999Klaus Linde, Michael Scholz +4 more
There was clear evidence that studies with better methodological quality tended to yield less positive results, and meta-regression methods simultaneously investigating the influence of single study features seem the best method for investigating the impact of study quality on outcome.
Journal of Clinical OncologyA quality assessment of randomized control trials of primary treatment of breast cancer.
198 Citations1986A. Liberati, Harvey N. Himel +1 more
There was evidence that quality has improved over time and that the increasing tendency of involving a biostatistician in the research team was positively associated with the improvement of the internal validity but not with the external.
BMJReducing errors made by emergency physicians in interpreting radiographs: longitudinal study
165 Citations2000James Espinosa
Systems of radiograph interpretation that optimise the skills of all clinicians involved and contain reliable processes for mitigating errors can reduce error rates substantially.
The LancetRandomised trials, human nature, and reporting guidelines
153 Citations1996Kenneth F. Schulz
CirculationThe randomized clinical trial: bias in analysis.
152 Citations1981Graham S. May, David L. DeMets +3 more
It is recommended that reported study results should include outcome data from all subjects randomized in the group to which they were originally assigned.
American Journal of EpidemiologyQuality Scores Are Useless and Potentially Misleading: Reply to “Re: A Critical Look at Some Popular Analytic Methods”
148 Citations1994Sander Greenland
BMJImproving doctor-patient communication
139 Citations1998Siegfried Meryn
Paradigms of communication between patients and doctors, increasing patient dissatisfaction, rising numbers of complaints and claims for malpractice, and abandonment of conventional medicine for alternatives that are often unproved are faced.
Journal of Epidemiology & Community HealthPutting trials on trial--the costs and consequences of small trials in depression: a systematic review of methodology.
131 Citations1997Matthew Hotopf, Glyn Lewis +1 more
Why, despite 122 randomised controlled trials, there is no consensus about whether the selective serotonin reuptake inhibitors or tricyclic and related antidepressants should be used as first line treatment of depression is determined.
Statistical Methods in Medical ResearchControversies in meta-analysis: the case of the trials of serum cholesterol reduction
119 Citations1993SG Thompson
It is concluded that the long-term benefits of serum cholesterol reduction on the risk of heart disease have been seriously underestimated in some previous meta-analyses, while the evidence for adverse effects on other causes of death have been misleadingly exaggerated.
InjuryThe association between seniority of Accident and Emergency doctor and outcome following trauma
39 Citations1999Jonathan P. Wyatt, Jenny Henry +1 more
Analysis of outcome according to the grade of junior A&E doctor suggested a step-wise improvement in outcome with seniority, thus supporting the concept that an improved outcome is associated with experience and seniority.
Acta Obstetricia Et Gynecologica ScandinavicaAmniotomy Or Oxytocin For Induction Of Labor: Re‐Analysis Of A Randomized Controlled Trial
21 Citations1988Marc J. N. C. Keirse
Clinical attitudes were found to statistically significantly influence the prescribed assessments 4 h after entry into the trial and the selection of the second intervention that was required in the absence of acceptable progress, resulting in an inverse relationship between “acceptable progress within 4 hours” and “delivery within 24 hours’ after induction.
Archives of OphthalmologyGuilty Until Proved Innocent
13 Citations1967Harvey Lincoff
The first days after the occurrence of a retinal tear furnish the ophthalmologist with an opportunity to make an early diagnosis and to provide treatment with the greatest chance for reattachment and a good visual result.
