Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement_Chinese Journal of Evidence-Based Medicine

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面对随机对照试验（RCTs）报告质量过低的种种确凿证据和严重后果，许多医学杂志及编辑小组现已接受并支持一份包含有22个条目的清单和一个流程图的CONSORT声明（试验报告统一标准）。由于CONSORT的主旨是提高干预措施疗效的报告质量，故其中只有一个条目是具体针对安全性的。
大量证据表明，报告RCT中的危害的相关数据的报告质量有待提高。2003年5月，CONSORT小组成员，包括杂志编辑和科学家，齐聚加拿大魁北克省Mentoebello探讨了这一问题，并形成以下文件：标准CONSORT清单附带报告危害相关问题的10个新推荐意见，并附上说明及恰当报告的实例。
我们希望该声明连同其它CONSORT相关材料（www.consort-statement.org）将有助于作者提高RCT报告中与危害相关数据的报告质量。高质量报告有助于读者批判性评价和诠释试验结果。各杂志可通过修改稿约来向作者传达这一文件以支持这一目标。

Citation： John P,A,Ioannidis MD,Stephen J,W,Evans MSc,Peter C,Goslash,tzsche MD,DrMedSci,Robert T,ONeill PhD,Douglas G,Altman DSc,Kenneth Schulz PhD,and David Moher PhD,for the CONSORT Group. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement. Chinese Journal of Evidence-Based Medicine, 2006, 06(9): 682-689. doi: Copy

1.	Cuervo LG, Clarke M. Balancing benefits and harms in health care [Editorial]. BMJ, 2003; 327: 65–66.
2.	Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med, 2001; 134: 663–694.
3.	Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 2001; 285: 1987–1991.
4.	Stephens MD, Talbot JC, Routledge PA, eds. The Detection of New Adverse Reactions. 4th ed. London: Macmillan Reference; 1998.
5.	Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet, 2000; 356: 1255–1259.
6.	Ioannidis JP, Contopoulos-Ioannidis DG. Reporting of safety data from randomized trials [Letter]. Lancet, 1998; 352: 1752–1753.
7.	Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA, 2001; 285: 437–443.
8.	Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials, 1989; 10: 31-56.
9.	Loke YK, Derry S. Reporting of adverse drug reactions in randomised controlled trials—a systematic survey. BMC Clin Pharmacol, 2001; 1: 3.
10.	Edwards JE, McQuay HJ, Moore RA, et al. Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain. J Pain Symptom Manage, 1999; 18: 427–437.
11.	Hayashi K, Walker AM. Japanese and American reports of randomized trials: differences in the reporting of adverse effects. Control Clin Trials, 1996; 17: 99–110.
12.	Papanikolaou PN, Churchill R, Wahlbeck K, et al. Safety reporting in randomized trials of mental health interventions. Am J Psychiatry, 2004; 161: 1692–1697.
13.	Martin RC 2nd, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg, 2002; 235: 803–813.
14.	Ioannidis JP, Chew P, Lau J. Standardized retrieval of side effects data for meta-analysis of safety outcomes. A feasibility study in acute sinusitis. J Clin Epidemiol, 2002; 55: 619–626.
15.	Ioannidis JP, Lau J. Improving safety reporting from randomised trials. Drug Saf, 2002; 25: 77–84.
16.	Mucklow JC. Reporting drug safety in clinical trials: getting the emphasis right. Lancet, 2001; 357: 1384.
17.	Lesko SM, Mitchell AA. An assessment of the safety of pediatric ibuprofen. A practitioner-based randomized clinical trial. JAMA, 1995; 273: 929–933.
18.	Castle W, Fuller R, Hall J, et al. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ, 1993; 306: 1034–1037.
19.	Derry S, Kong Loke Y, Aronson JK. Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials. BMC Med Res Methodol, 2001; 1: 7.
20.	Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther, 1987; 42: 250–253.
21.	Rochon PA, Binns MA, Litner JA, et al. Are randomized control trial outcomes influenced by the inclusion of a placebo group? A systematic review of nonsteroidal antiinflammatory drug trials for arthritis treatment. J Clin Epidemiol, 1999; 52: 113–122.
22.	Peloso PM, Wright JG, Bombardier C. A critical appraisal of toxicity indexes in rheumatology. J Rheumatol, 1995; 22: 989–994.
23.	Marshall M, Lockwood A, Bradley C, et al. Unpublished rating scales: a major source of bias in randomised controlled trials of reatments for schizophrenia. Br J Psychiatry, 2000; 176: 249–252.
24.	Vitiello B, Riddle MA, Greenhill LL, et al. How can we improve the assessment of safety in child and adolescent psychopharmacology? J Am Acad Child Adolesc Psychiatry, 2003; 42: 634–641.
25.	Bonhoeffer J, Kohl K, Chen R, et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). Vaccine, 2002; 21: 298–302.
26.	Woodworth TG, Furst DE, Strand V, et al. Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies. J Rheumatol, 2001; 28: 1163–1169.
27.	Trotti A, Bentzen SM. The need for adverse effects reporting standards in oncology clinical trials [Editorial]. J Clin Oncol, 2004; 22: 19–22.
28.	Kohl KS, Bonhoeffer J, Chen R, et al. The Brighton Collaboration: enhancing comparability of vaccine safety data. Pharmacoepidemiol Drug Saf, 2003; 12: 335–340.
29.	Division of AIDS. Table for Grading Severity of Adult Adverse Experiences. Rockville, MD: National Institute of Allergy and Infectious Diseases; 1992.
30.	Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer, 1981; 47: 207–214.
31.	Common Toxicity Criteria, version 2. Bethesda, MD: National Cancer Institute; 1999.
32.	Corso DM, Pucino F, DeLeo JM, et al. Development of a questionnaire for detecting potential adverse drug reactions. Ann Pharmacother, 1992; 26: 890–896.
33.	Wallin J, Sjovall J. Detection of adverse drug reactions in a clinical trial using two types of questioning. Clin Ther, 1981; 3: 450–452.
34.	Gøtzsche PC. Non-steroidal anti-inflammatory drugs. BMJ, 2000; 320: 1058–1061.
35.	Roehrborn CG. Reporting of acute urinary retention in BPH treatment trials: importance of patient follow-up after discontinuation and case definitions. Urology, 2002; 59: 811–815.
36.	Wahlbeck K, Tuunainen A, Ahokas A, et al. Dropout rates in randomized antipsychotic drug trials. Psychopharmacology (Berl), 2001; 155: 230–233.
37.	Whitehead J. On being the statistician on a Data and Safety Monitoring Board. Stat Med, 1999; 18: 3425–3434.
38.	Thall PF, Cheng SC. Optimal two-stage designs for clinical trials based on safety and efficacy. Stat Med, 2001; 20: 1023–1032.
39.	Sanders C, Egger M, Donovan J, et al. Reporting on quality of life in randomised controlled trials: bibliographic study. BMJ, 1998; 317: 1191–1194.
40.	Smith A. Report of the Statisticians in the Pharmaceutical Industry Working Party, 1980.
41.	Chuang-Stein C. Laboratory data in clinical trials: a statistician’s perspective. Control Clin Trials, 1998; 19: 167–177.
42.	Cato A. Premarketing adverse drug experiences: data management procedures. Unexpected death occurring early in clinical trials. Drug Inf J, 1987; 21: 3–7.
43.	Chan AW, Hro´bjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA, 2004; 291: 2457–2465.
44.	Jovanovic BD, Zalenski RJ. Safety evaluation and confidence intervals when the number of observed events is small or zero. Ann Emerg Med, 1997; 30:301–306.
45.	Oxman AD, Guyatt GH. A consumer’s guide to subgroup analyses. Ann Intern Med, 1992; 116: 78–84.
46.	Yusuf S, Wittes J, Probstfield J, et al. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA, 1991; 266: 93–98.
47.	Clarke M, Alderson P, Chalmers I. Discussion sections in reports of controlled trials published in general medical journals. JAMA, 2002; 287: 2799–2801.
48.	Docherty M, Smith R. The case for structuring the discussion of scientific papers [Editorial]. BMJ, 1999; 318: 1224–1225.
49.	O’Neill RT. Regulatory perspectives on data monitoring. Stat Med, 2002; 21: 2831–2842.

1. Cuervo LG, Clarke M. Balancing benefits and harms in health care [Editorial]. BMJ, 2003; 327: 65–66.
2. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med, 2001; 134: 663–694.
3. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 2001; 285: 1987–1991.
4. Stephens MD, Talbot JC, Routledge PA, eds. The Detection of New Adverse Reactions. 4th ed. London: Macmillan Reference; 1998.
5. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet, 2000; 356: 1255–1259.
6. Ioannidis JP, Contopoulos-Ioannidis DG. Reporting of safety data from randomized trials [Letter]. Lancet, 1998; 352: 1752–1753.
7. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA, 2001; 285: 437–443.
8. Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials, 1989; 10: 31-56.
9. Loke YK, Derry S. Reporting of adverse drug reactions in randomised controlled trials—a systematic survey. BMC Clin Pharmacol, 2001; 1: 3.
10. Edwards JE, McQuay HJ, Moore RA, et al. Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain. J Pain Symptom Manage, 1999; 18: 427–437.
11. Hayashi K, Walker AM. Japanese and American reports of randomized trials: differences in the reporting of adverse effects. Control Clin Trials, 1996; 17: 99–110.
12. Papanikolaou PN, Churchill R, Wahlbeck K, et al. Safety reporting in randomized trials of mental health interventions. Am J Psychiatry, 2004; 161: 1692–1697.
13. Martin RC 2nd, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg, 2002; 235: 803–813.
14. Ioannidis JP, Chew P, Lau J. Standardized retrieval of side effects data for meta-analysis of safety outcomes. A feasibility study in acute sinusitis. J Clin Epidemiol, 2002; 55: 619–626.
15. Ioannidis JP, Lau J. Improving safety reporting from randomised trials. Drug Saf, 2002; 25: 77–84.
16. Mucklow JC. Reporting drug safety in clinical trials: getting the emphasis right. Lancet, 2001; 357: 1384.
17. Lesko SM, Mitchell AA. An assessment of the safety of pediatric ibuprofen. A practitioner-based randomized clinical trial. JAMA, 1995; 273: 929–933.
18. Castle W, Fuller R, Hall J, et al. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ, 1993; 306: 1034–1037.
19. Derry S, Kong Loke Y, Aronson JK. Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials. BMC Med Res Methodol, 2001; 1: 7.
20. Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther, 1987; 42: 250–253.
21. Rochon PA, Binns MA, Litner JA, et al. Are randomized control trial outcomes influenced by the inclusion of a placebo group? A systematic review of nonsteroidal antiinflammatory drug trials for arthritis treatment. J Clin Epidemiol, 1999; 52: 113–122.
22. Peloso PM, Wright JG, Bombardier C. A critical appraisal of toxicity indexes in rheumatology. J Rheumatol, 1995; 22: 989–994.
23. Marshall M, Lockwood A, Bradley C, et al. Unpublished rating scales: a major source of bias in randomised controlled trials of reatments for schizophrenia. Br J Psychiatry, 2000; 176: 249–252.
24. Vitiello B, Riddle MA, Greenhill LL, et al. How can we improve the assessment of safety in child and adolescent psychopharmacology? J Am Acad Child Adolesc Psychiatry, 2003; 42: 634–641.
25. Bonhoeffer J, Kohl K, Chen R, et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). Vaccine, 2002; 21: 298–302.
26. Woodworth TG, Furst DE, Strand V, et al. Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies. J Rheumatol, 2001; 28: 1163–1169.
27. Trotti A, Bentzen SM. The need for adverse effects reporting standards in oncology clinical trials [Editorial]. J Clin Oncol, 2004; 22: 19–22.
28. Kohl KS, Bonhoeffer J, Chen R, et al. The Brighton Collaboration: enhancing comparability of vaccine safety data. Pharmacoepidemiol Drug Saf, 2003; 12: 335–340.
29. Division of AIDS. Table for Grading Severity of Adult Adverse Experiences. Rockville, MD: National Institute of Allergy and Infectious Diseases; 1992.
30. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer, 1981; 47: 207–214.
31. Common Toxicity Criteria, version 2. Bethesda, MD: National Cancer Institute; 1999.
32. Corso DM, Pucino F, DeLeo JM, et al. Development of a questionnaire for detecting potential adverse drug reactions. Ann Pharmacother, 1992; 26: 890–896.
33. Wallin J, Sjovall J. Detection of adverse drug reactions in a clinical trial using two types of questioning. Clin Ther, 1981; 3: 450–452.
34. Gøtzsche PC. Non-steroidal anti-inflammatory drugs. BMJ, 2000; 320: 1058–1061.
35. Roehrborn CG. Reporting of acute urinary retention in BPH treatment trials: importance of patient follow-up after discontinuation and case definitions. Urology, 2002; 59: 811–815.
36. Wahlbeck K, Tuunainen A, Ahokas A, et al. Dropout rates in randomized antipsychotic drug trials. Psychopharmacology (Berl), 2001; 155: 230–233.
37. Whitehead J. On being the statistician on a Data and Safety Monitoring Board. Stat Med, 1999; 18: 3425–3434.
38. Thall PF, Cheng SC. Optimal two-stage designs for clinical trials based on safety and efficacy. Stat Med, 2001; 20: 1023–1032.
39. Sanders C, Egger M, Donovan J, et al. Reporting on quality of life in randomised controlled trials: bibliographic study. BMJ, 1998; 317: 1191–1194.
40. Smith A. Report of the Statisticians in the Pharmaceutical Industry Working Party, 1980.
41. Chuang-Stein C. Laboratory data in clinical trials: a statistician’s perspective. Control Clin Trials, 1998; 19: 167–177.
42. Cato A. Premarketing adverse drug experiences: data management procedures. Unexpected death occurring early in clinical trials. Drug Inf J, 1987; 21: 3–7.
43. Chan AW, Hro´bjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA, 2004; 291: 2457–2465.
44. Jovanovic BD, Zalenski RJ. Safety evaluation and confidence intervals when the number of observed events is small or zero. Ann Emerg Med, 1997; 30:301–306.
45. Oxman AD, Guyatt GH. A consumer’s guide to subgroup analyses. Ann Intern Med, 1992; 116: 78–84.
46. Yusuf S, Wittes J, Probstfield J, et al. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA, 1991; 266: 93–98.
47. Clarke M, Alderson P, Chalmers I. Discussion sections in reports of controlled trials published in general medical journals. JAMA, 2002; 287: 2799–2801.
48. Docherty M, Smith R. The case for structuring the discussion of scientific papers [Editorial]. BMJ, 1999; 318: 1224–1225.
49. O’Neill RT. Regulatory perspectives on data monitoring. Stat Med, 2002; 21: 2831–2842.

Chinese Journal of Evidence-Based Medicine

Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

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