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December 28, 1994, Vol 272, No. 24 >
ARTICLE | December 28, 1994

A Proposal for Structured Reporting of Randomized Controlled Trials FREE

Erik Andrew, PhD; Aslam Anis, PhD; Tom Chalmers, MD; Mildred Cho, PhD; Mike Clarke, PhD; David Felson, MD; Peter Gøtzsche, MD; Richard Greene, MD, PhD; Alejandro Jadad, MD; Wayne Jonas, MD; Terry Klassen, MD; Paul Knipschild, MD; Andreas Laupacis, MD, MSc; Curtis L. Meinert, PhD; David Moher, MSc; Graham Nichol, MD; Andy Oxman, MD; Marie-France Penman, BScN; Stuart Pocock, PhD; Joan Reisch, PhD; David Sackett, MD; Kenneth Schulz, PhD, MBA; Judy Snider; Peter Tugwell, MD; Jon Tyson, MD; France Varin, PhD; Wikke Walop, PhD; Sharon Walsh, MD; George Wells, PhD
[+] Author Affiliations

A complete list of the Standards of Reporting Trials Group appears at the end of the article.

Reprint requests to the Clinical Epidemiology Unit, Loeb Medical Research Institute, Ottawa Civic Hospital, 1053 Carling Ave, Ottawa, Ontario, Canada K1Y 4E9 (Mr Moher).


JAMA. 1994;272(24):1926-1931. doi:10.1001/jama.1994.03520240054041
Text Size: A A A
Published online
Article
References

A RANDOMIZED controlled trial (RCT) is the most reliable method of assessing the efficacy of health care interventions.1,2 Reports 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 Daniel3 reviewed 203 reports of drug trials published between 1956 and 1960 in the Canadian 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 colleagues4 reported 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

REFERENCES

1 +
Cook DJ, Guyatt GH, Laupacis A, Sackett DL.  Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest . 1992;;102: 305S-311S.
2 +
Sacks H, Chalmers TC, Smith H.  Randomized versus historical controls for clinical trials. Am J Med . 1982;;72:233-240.
3 +
Mahon WA, Daniel EE.  A method for the assessment of reports of drug trials. Can Med Assoc J . 1964;;90:565-569.
4 +
Pocock SJ, Hughes MD, Lee RJ.  Statistical problems in the reporting of clinical trials. N Engl J Med . 1987;;317:426-432.
5 +
Altman DG, Doré CJ.  Randomization and baseline comparisons in clinical trials. Lancet . 1990;;335: 149-153.
6 +
Schulz KF, Chalmers I, Grimes DA, Altman DG.  Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA . 1994;;272:125-128.
7 +
Gøtzsche PC.  Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal anti-inflammatory drugs in rheumatoid arthritis. Control Clin Trials . 1989;;10:31-56.
8 +
Correction. 1989;10:356.
9 +
Ad Hoc Working Group for Critical Appraisal of the Medical Literature.  A proposal for more informative abstracts of clinical articles. Ann Intern Med . 1987;;106:598-604.
10 +
Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ.  More informative abstracts revisited. Ann Intern Med . 1990;;113:69-76.
11 +
Moher D, Dulberg CS, Wells GA.  Statistical power, sample size, and their reporting in randomized controlled trials. JAMA . 1994;;272:122-124.
12 +
Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S.  Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials . In press.
13 +
Schulz KF, Chalmers I, Hayes RJ, Altman DG.  Emperical evidence of bias: dimensions of methodologic quality associated with estimates of treatment effects in controlled trials. JAMA . In press.
14 +
Schulz KF. Methodological Quality and Bias in Randomized Controlled Trials . London, England: University of London; 1994;. Thesis.
15 +
Chalmers I.  The Cochrane Collaboration: preparing, maintaining, and disseminating systematic reviews of the effects of health care. Ann N Y Acad Sci . 1993;;703:156-165.
16 +
Gøtzsche PC.  Bias in double-blind trials. Dan Med Bull . 1990;;37:329-336.
17 +
McDowell I, Newell C. Measuring Health: A Guide to Rating Scales and Questionnaires . New York, NY: Oxford University Press; 1987;.
18 +
Steiner DL, Norman GR. Health Measurement Scales: A Practical Guide to Their Development and Use . Oxford, England: Oxford University Press; 1989;.
19 +
Donner A, Brown KS, Brasher P.  A methodologic review of nontherapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epidemiol . 1990;;19:795-800.
20 +
Donner A.  Statistical methodology for paired cluster designs. Am J Epidemiol . 1987;; 126:972-979.
21 +
Altman DG.  Randomization: essential for reducing bias. BMJ . 1991;;302:1481-1482.
22 +
Hill AB.  The clinical trial. N Engl J Med . 1952;; 247:113-119.
23 +
Chalmers TC, Celano P, Sachs HS, Smith H.  Bias in treatment assignment in controlled clinical trials. N Engl J Med . 1983;;309:1358-1361.
24 +
Last JM, ed. A Dictionary of Epidemiology . 2nd ed. New York, NY: Oxford University Press; 1988;:38.
25 +
Altman DG.  Comparability of randomized groups. Statistician . 1985;;34:125-136.
26 +
Colditz GA, Miller JN, Mosteller F.  How study design affects outcomes in comparisons of therapy, I: medical. Stat Med . 1989;;8:441-454.
27 +
Karlowski TR, Chalmers TC, Frenkel LD, Kapikian AZ, Lewis TL, Lynch JM.  Ascorbic acid for the common cold: a prophylactic and therapeutic trial. JAMA . 1975;;231:1038-1042.
28 +
Sackett DL, Gent M.  Controversy in counting and attributing events in clinical trials. N Engl J Med . 1979;;301:1410-1412.
29 +
Sackett DL.  Bias in analytic research. J Chronic Dis . 1979;;32:51-63.
30 +
The Canadian Cooperative Study Group.  The Canadian trial of aspirin and sulfinpyrazone in threatened stroke. N Engl J Med . 1978;;299:53-59.
31 +
Moses LE, Emerson JD, Hosseini H.  Analyzing data from ordered categories. N Engl J Med . 1984;; 311:442-448
32 +
Fields WS, Maslenikov V, Mayer JS, Hass WK, Remington RD, Macdonald M.  Joint study of extra-cranial arterial occlusion, V: progress report of prognosis following surgery or nonsurgical treatment for transient cerebral ischemic attacks and cervical carotid artery lesions. JAMA . 1970;;211:1993-2003.
33 +
Pocock SJ. Clinical Trials: A Practical Approach . Chichester, England: John Wiley & Sons Inc; 1983;:182-186.
34 +
Laupacis A.  The validity of survivorship analysis in total joint arthroplasty. J Bone Joint Surg Am . 1989;;71:1111-1112.
35 +
Godfrey K.  Comparing the means of several groups.  In: Bailer JC III, Mosteller F, eds. Medical Uses of Statistics . 2nd ed. Boston, Mass: NEJM Books; 1992;:233-257.
36 +
Makuch R, Johnson M.  Issues in planning and interpreting active control equivalence studies. J Clin Epidemiol . 1989;;42:503-511.
37 +
The Coronary Drug Project Research Group.  Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Engl J Med . 1980;;303:1038-1041.
38 +
Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option? Stat Med . 1991;;10:1595-1605.
39 +
DerSimonian R, Charette LJ, McPeek B, Mosteller F.  Reporting on methods in clinical trials.  In: Bailer JC III, Mosteller F, eds. Medical Uses of Statistics . 2nd ed. Boston, Mass: NEJM Books; 1992;: 333-347.
40 +
Freiman JA, Chalmers TC, Smith H, Kuebler RR.  The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: survey of 71 'negative' trials. N Engl J Med . 1978;;299:690-694.
41 +
Laupacis A, Connolly SJ, Gent M, Roberts RS, Cairns JA, Joyner C, for the CAFA Study Group.  How should results from completed studies influence ongoing clinical trials? the CAFA Study experience. Ann Intern Med . 1991;;115:818-822.
42 +
Pocock SJ.  When to stop a clinical trial. BMJ . 1992;;305:235-240.
43 +
Evans M, Pollack AV.  Trials on trial: a review of trials of antibiotic prophylaxis. Arch Surg . 1984;; 119:109-113.
44 +
Gardner MJ, Bond J.  An exploratory study of statistical assessment of papers published in the British Medical Journal. JAMA . 1990;;263:1355-1357.
45 +
McKinney WP, Young MJ, Hartz A, Bi-Fong Lee M.  The inexact use of Fisher's Exact Test in six major medical journals. JAMA . 1989;;261:3430-3433.
46 +
Gardner MJ, Altman DG.  Estimation rather than hypothesis testing: confidence intervals rather than P values.  In: Gardner MJ, Altman DG, eds. Statistics With Confidence: Confidence Intervals and Statistical Guidelines . London, England: BMJ; 1989;:6-19.
47 +
Echt DS, Liebson PR, Mitchell LB, et al.  Mortality and morbidity in participants receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med . 1991;;324: 781-788.
48 +
Braitman LE.  Confidence intervals assess both clinical significance and statistical significance. Ann Intern Med . 1991;;114:515-517.
49 +
Amery A, Roeber G, Vermeulen HJ, Verstraete M.  Single-blind randomized multicentre trial comparing heparin and streptokinase treatment in recent myocardial infarction. Acta Med Scand . 1969;; 505:1-35.
50 +
Steering Committee of the Physicians' Health Research Group.  Final report on the aspirin component of the ongoing Physicians' Health Study. N Engl J Med . 1989;;321:129-135.
51 +
Bauer P.  Multiple testing in clinical trials. Stat Med . 1991;;10:871-890.
52 +
Bulpitt CJ.  Subgroup analysis. Lancet . 1988;;2: 31-34.
53 +
Oxman AD, Guyatt GH.  A consumer's guide to subgroup analyses. Ann Intern Med . 1992;;116:78-84.
54 +
Yusuf S, Wittes J, Probstfield J, Tyroler HA.  Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA . 1991;;266:93-98.
55 +
Simon R, Wittes RE.  Methodologic guidelines for reports of clinical trials. Can Treat Rep . 1985;;69:1-3.
56 +
Grant A.  Reporting controlled trials. Br J Obstet Gynaecol . 1989;;96:397-400.
57 +
Zelen M.  Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors. J Clin Oncol . 1983;;1:164-169.
58 +
Mosteller F, Gilbert JP, McPeek B.  Reporting standards and research strategies for controlled trials. Control Clin Trials . 1980;;1:37-58.
59 +
Gardner MJ, Machin D, Campbell MJ.  Use of checklists in assessing the statistical content of medical studies. BMJ . 1986;;292:810-812.
60 +
Gore SM, Jones G, Thompson SG.  The Lancet's statistical review process: areas for improvement by authors. Lancet . 1992;;340:100-102.
61 +
Altman DG.  Statistics in medical journals: developments in the 1980s. Stat Med . 1991;;10:1897-1913.
62 +
Turner JA, Deyo RA, Loeser JD, Von Korff M, Fordyce WE.  The importance of placebo effects in pain treatment and research. JAMA . 1994;;271:1609-1614.
63 +
Comans ML, Overbeke AJ.  The structured summary: a tool for reader and author. Ned Tijdschr Geneeskd . 1990;;134:2338-2343.
64 +
Laupacis A, Naylor CD, Sackett DL.  How should the results of clinical trials be presented to clinicians? ACP Journal Club . 1992;;A12-A14.
65 +
Rochon PA, Fortin PR, Dear KBG, Minaker KL, Chalmers TC.  Reporting of age data in clinical trials of arthritis: deficiencies and solutions. Arch Intern Med . 1993;;153:243-248.
66 +
Baar J, Tannock I.  Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials. J Clin Oncol . 1989;;7:969-978.

Figures

Tables

Interactive Graphics

Video

Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Cook DJ, Guyatt GH, Laupacis A, Sackett DL.  Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest . 1992;;102: 305S-311S.
2 +
Sacks H, Chalmers TC, Smith H.  Randomized versus historical controls for clinical trials. Am J Med . 1982;;72:233-240.
3 +
Mahon WA, Daniel EE.  A method for the assessment of reports of drug trials. Can Med Assoc J . 1964;;90:565-569.
4 +
Pocock SJ, Hughes MD, Lee RJ.  Statistical problems in the reporting of clinical trials. N Engl J Med . 1987;;317:426-432.
5 +
Altman DG, Doré CJ.  Randomization and baseline comparisons in clinical trials. Lancet . 1990;;335: 149-153.
6 +
Schulz KF, Chalmers I, Grimes DA, Altman DG.  Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA . 1994;;272:125-128.
7 +
Gøtzsche PC.  Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal anti-inflammatory drugs in rheumatoid arthritis. Control Clin Trials . 1989;;10:31-56.
8 +
Correction. 1989;10:356.
9 +
Ad Hoc Working Group for Critical Appraisal of the Medical Literature.  A proposal for more informative abstracts of clinical articles. Ann Intern Med . 1987;;106:598-604.
10 +
Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ.  More informative abstracts revisited. Ann Intern Med . 1990;;113:69-76.
11 +
Moher D, Dulberg CS, Wells GA.  Statistical power, sample size, and their reporting in randomized controlled trials. JAMA . 1994;;272:122-124.
12 +
Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S.  Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials . In press.
13 +
Schulz KF, Chalmers I, Hayes RJ, Altman DG.  Emperical evidence of bias: dimensions of methodologic quality associated with estimates of treatment effects in controlled trials. JAMA . In press.
14 +
Schulz KF. Methodological Quality and Bias in Randomized Controlled Trials . London, England: University of London; 1994;. Thesis.
15 +
Chalmers I.  The Cochrane Collaboration: preparing, maintaining, and disseminating systematic reviews of the effects of health care. Ann N Y Acad Sci . 1993;;703:156-165.
16 +
Gøtzsche PC.  Bias in double-blind trials. Dan Med Bull . 1990;;37:329-336.
17 +
McDowell I, Newell C. Measuring Health: A Guide to Rating Scales and Questionnaires . New York, NY: Oxford University Press; 1987;.
18 +
Steiner DL, Norman GR. Health Measurement Scales: A Practical Guide to Their Development and Use . Oxford, England: Oxford University Press; 1989;.
19 +
Donner A, Brown KS, Brasher P.  A methodologic review of nontherapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epidemiol . 1990;;19:795-800.
20 +
Donner A.  Statistical methodology for paired cluster designs. Am J Epidemiol . 1987;; 126:972-979.
21 +
Altman DG.  Randomization: essential for reducing bias. BMJ . 1991;;302:1481-1482.
22 +
Hill AB.  The clinical trial. N Engl J Med . 1952;; 247:113-119.
23 +
Chalmers TC, Celano P, Sachs HS, Smith H.  Bias in treatment assignment in controlled clinical trials. N Engl J Med . 1983;;309:1358-1361.
24 +
Last JM, ed. A Dictionary of Epidemiology . 2nd ed. New York, NY: Oxford University Press; 1988;:38.
25 +
Altman DG.  Comparability of randomized groups. Statistician . 1985;;34:125-136.
26 +
Colditz GA, Miller JN, Mosteller F.  How study design affects outcomes in comparisons of therapy, I: medical. Stat Med . 1989;;8:441-454.
27 +
Karlowski TR, Chalmers TC, Frenkel LD, Kapikian AZ, Lewis TL, Lynch JM.  Ascorbic acid for the common cold: a prophylactic and therapeutic trial. JAMA . 1975;;231:1038-1042.
28 +
Sackett DL, Gent M.  Controversy in counting and attributing events in clinical trials. N Engl J Med . 1979;;301:1410-1412.
29 +
Sackett DL.  Bias in analytic research. J Chronic Dis . 1979;;32:51-63.
30 +
The Canadian Cooperative Study Group.  The Canadian trial of aspirin and sulfinpyrazone in threatened stroke. N Engl J Med . 1978;;299:53-59.
31 +
Moses LE, Emerson JD, Hosseini H.  Analyzing data from ordered categories. N Engl J Med . 1984;; 311:442-448
32 +
Fields WS, Maslenikov V, Mayer JS, Hass WK, Remington RD, Macdonald M.  Joint study of extra-cranial arterial occlusion, V: progress report of prognosis following surgery or nonsurgical treatment for transient cerebral ischemic attacks and cervical carotid artery lesions. JAMA . 1970;;211:1993-2003.
33 +
Pocock SJ. Clinical Trials: A Practical Approach . Chichester, England: John Wiley & Sons Inc; 1983;:182-186.
34 +
Laupacis A.  The validity of survivorship analysis in total joint arthroplasty. J Bone Joint Surg Am . 1989;;71:1111-1112.
35 +
Godfrey K.  Comparing the means of several groups.  In: Bailer JC III, Mosteller F, eds. Medical Uses of Statistics . 2nd ed. Boston, Mass: NEJM Books; 1992;:233-257.
36 +
Makuch R, Johnson M.  Issues in planning and interpreting active control equivalence studies. J Clin Epidemiol . 1989;;42:503-511.
37 +
The Coronary Drug Project Research Group.  Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Engl J Med . 1980;;303:1038-1041.
38 +
Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option? Stat Med . 1991;;10:1595-1605.
39 +
DerSimonian R, Charette LJ, McPeek B, Mosteller F.  Reporting on methods in clinical trials.  In: Bailer JC III, Mosteller F, eds. Medical Uses of Statistics . 2nd ed. Boston, Mass: NEJM Books; 1992;: 333-347.
40 +
Freiman JA, Chalmers TC, Smith H, Kuebler RR.  The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: survey of 71 'negative' trials. N Engl J Med . 1978;;299:690-694.
41 +
Laupacis A, Connolly SJ, Gent M, Roberts RS, Cairns JA, Joyner C, for the CAFA Study Group.  How should results from completed studies influence ongoing clinical trials? the CAFA Study experience. Ann Intern Med . 1991;;115:818-822.
42 +
Pocock SJ.  When to stop a clinical trial. BMJ . 1992;;305:235-240.
43 +
Evans M, Pollack AV.  Trials on trial: a review of trials of antibiotic prophylaxis. Arch Surg . 1984;; 119:109-113.
44 +
Gardner MJ, Bond J.  An exploratory study of statistical assessment of papers published in the British Medical Journal. JAMA . 1990;;263:1355-1357.
45 +
McKinney WP, Young MJ, Hartz A, Bi-Fong Lee M.  The inexact use of Fisher's Exact Test in six major medical journals. JAMA . 1989;;261:3430-3433.
46 +
Gardner MJ, Altman DG.  Estimation rather than hypothesis testing: confidence intervals rather than P values.  In: Gardner MJ, Altman DG, eds. Statistics With Confidence: Confidence Intervals and Statistical Guidelines . London, England: BMJ; 1989;:6-19.
47 +
Echt DS, Liebson PR, Mitchell LB, et al.  Mortality and morbidity in participants receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med . 1991;;324: 781-788.
48 +
Braitman LE.  Confidence intervals assess both clinical significance and statistical significance. Ann Intern Med . 1991;;114:515-517.
49 +
Amery A, Roeber G, Vermeulen HJ, Verstraete M.  Single-blind randomized multicentre trial comparing heparin and streptokinase treatment in recent myocardial infarction. Acta Med Scand . 1969;; 505:1-35.
50 +
Steering Committee of the Physicians' Health Research Group.  Final report on the aspirin component of the ongoing Physicians' Health Study. N Engl J Med . 1989;;321:129-135.
51 +
Bauer P.  Multiple testing in clinical trials. Stat Med . 1991;;10:871-890.
52 +
Bulpitt CJ.  Subgroup analysis. Lancet . 1988;;2: 31-34.
53 +
Oxman AD, Guyatt GH.  A consumer's guide to subgroup analyses. Ann Intern Med . 1992;;116:78-84.
54 +
Yusuf S, Wittes J, Probstfield J, Tyroler HA.  Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA . 1991;;266:93-98.
55 +
Simon R, Wittes RE.  Methodologic guidelines for reports of clinical trials. Can Treat Rep . 1985;;69:1-3.
56 +
Grant A.  Reporting controlled trials. Br J Obstet Gynaecol . 1989;;96:397-400.
57 +
Zelen M.  Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors. J Clin Oncol . 1983;;1:164-169.
58 +
Mosteller F, Gilbert JP, McPeek B.  Reporting standards and research strategies for controlled trials. Control Clin Trials . 1980;;1:37-58.
59 +
Gardner MJ, Machin D, Campbell MJ.  Use of checklists in assessing the statistical content of medical studies. BMJ . 1986;;292:810-812.
60 +
Gore SM, Jones G, Thompson SG.  The Lancet's statistical review process: areas for improvement by authors. Lancet . 1992;;340:100-102.
61 +
Altman DG.  Statistics in medical journals: developments in the 1980s. Stat Med . 1991;;10:1897-1913.
62 +
Turner JA, Deyo RA, Loeser JD, Von Korff M, Fordyce WE.  The importance of placebo effects in pain treatment and research. JAMA . 1994;;271:1609-1614.
63 +
Comans ML, Overbeke AJ.  The structured summary: a tool for reader and author. Ned Tijdschr Geneeskd . 1990;;134:2338-2343.
64 +
Laupacis A, Naylor CD, Sackett DL.  How should the results of clinical trials be presented to clinicians? ACP Journal Club . 1992;;A12-A14.
65 +
Rochon PA, Fortin PR, Dear KBG, Minaker KL, Chalmers TC.  Reporting of age data in clinical trials of arthritis: deficiencies and solutions. Arch Intern Med . 1993;;153:243-248.
66 +
Baar J, Tannock I.  Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials. J Clin Oncol . 1989;;7:969-978.

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