A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group.

A RANDOMIZED controlled trial (RCT) is the most reliable method of assessing the efficacy of health care interventions.1,2Reports of RCTs should provide readers with adequate information about what went on in the design, execution, analysis, and interpretation of the trial. Such reports will help readers judge the validity of the trial. There have been several investigations evaluating how RCTs are reported. In an early study, Mahon and Daniel3reviewed 203 reports of drug trials published between 1956 and 1960 in theCanadian Medical Association Journal. Only 11 reports (5.4%) fulfilled their criteria of a valid report. In a review of 45 trials published during 1985 in three leading general medical journals, Pocock and colleagues4reported that a statement about sample size was only mentioned in five (11.1%) of the reports, that only six (13.3%) made use of confidence intervals, and that the statistical analyses tended to

[1]  Douglas G. Altman,et al.  RANDOMISATION : ESSENTIAL FOR REDUCING BIAS , 1991 .

[2]  P Bauer,et al.  Multiple testing in clinical trials. , 1991, Statistics in medicine.

[3]  J. Wittes,et al.  Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. , 1991, JAMA.

[4]  A Donner,et al.  Statistical methodology for paired cluster designs. , 1987, American journal of epidemiology.

[5]  D. Sackett,et al.  Controversy in counting and attributing events in clinical trials. , 1979, The New England journal of medicine.

[6]  R A Deyo,et al.  The importance of placebo effects in pain treatment and research. , 1994, JAMA.

[7]  M. Evans,et al.  Trials on trial. A review of trials of antibiotic prophylaxis. , 1984, Archives of surgery.

[8]  Anna C. Balazs,et al.  Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. , 1980, The New England journal of medicine.

[9]  W. S. Fields,et al.  Joint study of extracranial arterial occlusion. V. Progress report of prognosis following surgery or nonsurgical treatment for transient cerebral ischemic attacks and cervical carotid artery lesions. , 1970 .

[10]  A. Amery,et al.  Single-blind randomised multicentre trial comparing heparin and streptokinase treatment in recent myocardial infarction. , 1969, Acta medica Scandinavica. Supplementum.

[11]  J D Emerson,et al.  Analyzing data from ordered categories. , 1984, The New England journal of medicine.

[12]  G H Guyatt,et al.  A Consumer's Guide to Subgroup Analyses , 1992, Annals of Internal Medicine.

[13]  M J Campbell,et al.  Use of check lists in assessing the statistical content of medical studies. , 1986, British medical journal.

[14]  T C Chalmers,et al.  Randomized versus historical controls for clinical trials. , 1982, The American journal of medicine.

[15]  A Hartz,et al.  The inexact use of Fisher's Exact Test in six major medical journals. , 1989, JAMA.

[16]  R. Wittes,et al.  Methodologic guidelines for reports of clinical trials. , 1985, Cancer treatment reports.

[17]  R. Makuch,et al.  Issues in planning and interpreting active control equivalence studies. , 1989, Journal of clinical epidemiology.

[18]  Leonard E. Brahman.  Confidence Intervals Assess Both Clinical Significance and Statistical Significance , 1991 .

[19]  P. Gøtzsche.  Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. , 1989, Controlled clinical trials.

[20]  T C Chalmers,et al.  The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials. , 1978, The New England journal of medicine.

[21]  L. Braitman.  Confidence intervals assess both clinical significance and statistical significance. , 1991, Annals of internal medicine.

[22]  C. Bulpitt.  SUBGROUP ANALYSIS , 1988, The Lancet.

[23]  R. J. Hayes,et al.  Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. , 1995, JAMA.

[24]  S. Pocock,et al.  Clinical Trials: A Practical Approach , 1984 .

[25]  T C Chalmers,et al.  Ascorbic acid for the common cold. A prophylactic and therapeutic trial. , 1975, JAMA.

[26]  I. Tannock,et al.  Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials. , 1989, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[27]  D. Altman.  Comparability of Randomised Groups , 1985 .

[28]  J. Whisnant.  The Canadian trial of aspirin and sulfinpyrazone in threatened stroke. , 1980, American heart journal.

[29]  A. Laupacis.  The validity of survivorship analysis in total joint arthroplasty. , 1989, The Journal of bone and joint surgery. American volume.

[30]  Hill Ab,et al.  The clinical trial. , 1952 .

[31]  Bias in treatment assignment in controlled clinical trials. , 1984, The New England journal of medicine.

[32]  D. Sackett.  Bias in analytic research. , 1979, Journal of chronic diseases.

[33]  S. Pocock,et al.  Statistical problems in the reporting of clinical trials. A survey of three medical journals. , 1987, The New England journal of medicine.

[34]  W A MAHON,et al.  A METHOD FOR THE ASSESSMENT OF REPORTS OF DRUG TRIALS. , 1964, Canadian Medical Association journal.

[35]  F. Mosteller,et al.  Reporting standards and research strategies for controlled trials , 1980 .

[36]  S. M. Gore,et al.  The Lancet's statistical review process: areas for improvement by authors , 1992, The Lancet.

[37]  I. Chalmers.  The Cochrane Collaboration: Preparing, Maintaining, and Disseminating Systematic Reviews of the Effects of Health Care , 1993, Annals of the New York Academy of Sciences.

[38]  I. McDowell,et al.  Measuring health: A guide to rating scales and questionnaires, 3rd ed. , 2006 .

[39]  J H Ellenberg,et al.  Analysis of clinical trials by treatment actually received: is it really an option? , 1991, Statistics in medicine.

[40]  A. B. Hill.  The clinical trial. , 1952, The New England journal of medicine.

[41]  H L Greene,et al.  Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. , 1991, The New England journal of medicine.

[42]  A. Laupacis,et al.  How should the results of clinical trials be presented to clinicians? , 1992, ACP Journal Club.

[43]  M J Gardner,et al.  An exploratory study of statistical assessment of papers published in the British Medical Journal. , 1990, JAMA.

[44]  Final report on the aspirin component of the ongoing Physicians' Health Study. , 1989, The New England journal of medicine.

[45]  A Pollock,et al.  When to stop a clinical trial. , 1992, BMJ.

[46]  Douglas G. Altman,et al.  Comparability of randomized groups , 1984 .

[47]  M. Zelen.  Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors. , 1983, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[48]  F. Mosteller,et al.  Reporting on methods in clinical trials. , 2019, The New England journal of medicine.

[49]  M. Gardner,et al.  More informative abstracts revisited. , 1990, The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association.

[50]  D. Streiner,et al.  Health Measurement Scales: A practical guide to thier development and use , 1989 .

[51]  G. Pc.  Bias in double-blind trials. , 1990 .

[52]  F. Mosteller,et al.  How study design affects outcomes in comparisons of therapy. I: Medical. , 1989, Statistics in medicine.

[53]  Haack Dg,et al.  Comparing the means of several groups. , 1986 .

[54]  Comans Ml,et al.  [The structured summary: a tool for reader and author]. , 1990 .

[55]  D G Altman,et al.  Statistics in medical journals: developments in the 1980s. , 1991, Statistics in medicine.

[56]  P. Rochon,et al.  Reporting of age data in clinical trials of arthritis. Deficiencies and solutions. , 1993, Archives of internal medicine.

[57]  A. Grant,et al.  Reporting controlled trials , 1989, British journal of obstetrics and gynaecology.

[58]  D G Altman,et al.  Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. , 1994, JAMA.

[59]  M Gent,et al.  How should results from completed studies influence ongoing clinical trials? The CAFA Study experience. , 1991, Annals of internal medicine.

[60]  F. Gutzwiller,et al.  A proposal for more informative abstracts of clinical articles. Ad Hoc Working Group for Critical Appraisal of the Medical Literature. , 1987, Annals of internal medicine.

[61]  A R Jadad,et al.  Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. , 1995, Controlled clinical trials.

[62]  M. Gardner,et al.  Confidence intervals rather than P values: estimation rather than hypothesis testing. , 1986, British medical journal.

[63]  D. Cook,et al.  Rules of evidence and clinical recommendations on the use of antithrombotic agents. , 1992, Chest.

[64]  A Donner,et al.  A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989. , 1990, International journal of epidemiology.

[65]  D. G. Altman,et al.  Randomisation and baseline comparisons in clinical trials , 1990, The Lancet.

[66]  D. Warner,et al.  Statistical power, sample size, and their reporting in randomized controlled trials , 1995 .