Journal of Clinical Epidemiology
Volume 58, Issue 8 , Pages 785-790 , August 2005

Powering our way to the elusive side effect: A composite outcome ‘basket’ of predefined designated endpoints in each organ system should be included in all controlled trials

  • Peter Tugwell

      Affiliations

    • Institute of Population Health, University of Ottawa, 1 Stewart Street, Room 312, Ottawa, Ontario K1N 6N5, Canada
    • Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
    • Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada
    • Corresponding Author InformationCorresponding author. Tel.: 613-562-5800 ext. 1945; fax: 613-562-5659.
    • ,
  • Maria G. Judd

      Affiliations

    • Institute of Population Health, University of Ottawa, 1 Stewart Street, Room 312, Ottawa, Ontario K1N 6N5, Canada
    • ,
  • Jim F. Fries

      Affiliations

    • Division of Immunology and Rheumatology, Stanford University School of Medicine, Stanford, CA, USA
    • ,
  • Gurkirpal Singh

      Affiliations

    • Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, USA
    • ,
  • George A. Wells

      Affiliations

    • Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada

,Accepted 30 November 2004.

References 

  1. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000;343:1520–15282 p following 1528
  2. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA. 2000;284:1247–1255
  3. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321–333
  4. Croft AM, Herxheimer A. Adverse effects of the antimalaria drug, mefloquine: due to primary liver damage with secondary thyroid involvement?. BMC Public Health. 2002;2:6
  5. Barrett PJ, Emmins PD, Clarke PD, Bradley DJ. Comparison of adverse events associated with use of mefloquine and combination of chloroquine and proguanil as antimalarial prophylaxis: postal and telephone survey of travellers. BMJ. 1996;313:525–528
  6. Baycol Information [Internet]. Updated August 8, 2001. Accessed June 4, 2003. Available at: http://www.fda.gov/cder/drug/infopage/baycol/default.htm.
  7. U.S. Food and Drug Administration, Press Office. Bayer Voluntarily Withdraws Baycol [Internet]. Updated August 8, 2001. Accessed April 6, 2003. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01095.html.
  8. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approval package for Baycol [Internet]. Updated June 26, 1997. Accessed June 4, 2003. Available at: www.fda.gov/cder/foi/nda97/020740ap_baycol_medrp1.pdf.
  9. Allen BR, Brewerton DA. Lessons from benoxaprofen. Lancet. 1982;2(8299):667
  10. Smith R. Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ. 2003;326:1202–1205
  11. Matthew T, Desmond P, Isaacs D, Lander C, Shenfield G, Wainwright D; Australian Drug Evaluation Committee; editors. Drugs that make you forget. Australian Adverse Drug Reactions Bulletin 1998;17(3):3 [Available at: http://www.tga.gov.au/docs/pdf/aadrbltn/aadr9808.pdf].
  12. Centocor. Important drug warning: Remicade (infliximab) [cover letter for product label] [Internet]. Updated October 5, 2001. Available at: http://www.fda.gov/medwatch/safety/2001/remicadeTB_deardoc.pdf.
  13. Wyeth Ayerst, Immunex. Important drug warning: Enbrel (etanercept) [cover letter for product label] [Internet]. Updated October 10, 2000. Available at: http://www.fda.gov/medwatch/safety/2000/enbrel1.pdf.
  14. U.S. Food and Drug Administration. Guidance documents [Internet]. Available at: http://www.fda.gov/cder/guidance/guidance.htm.
  15. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 3rd ed.. New York: Springer-Verlag; 1998;
  16. Tugwell P, Bombardier C. A methodologic framework for developing and selecting endpoints in clinical trials. J Rheumatol. 1982;9:758–762
  17. Boers M, Brooks P, Strand V, Tugwell P. The OMERACT filter for outcome measures in rheumatology. J Rheumatol. 1998;25:198–199
  18. Boers M, Tugwell P, Felson DT, van Riel PLCM, Kirwan JR, Edmonds JP, et al. WHO and ILAR core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol. 1994;21(Suppl 41):86–89
  19. Dougados M, Leclaire P, van der Heijde D, Bloch DA, Bellamy N, Altman RD. Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative. Osteoarthritis Cartilage. 2000;8:395–403
  20. Brooks P, Hochberg M, ILAR , OMERACT . Outcome measures and classification criteria for the rheumatic diseases: a compilation of data from OMERACT (Outcome Measures for Arthritis Clinical Trials), ILAR (International League of Associations for Rheumatology), regional leagues and other groups. Rheumatology (Oxford). 2001;40:896–906
  21. Fries JF. Toward an understanding of patient outcome measurement. Arthritis Rheumatol. 1983;26:697–704
  22. Singh G. Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database. Arthritis, Rheumatism, and Aging Medical Information System. Am J Ther. 2000;7:115–121
  23. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol. 1999;26(Suppl 56):18–24
  24. Woodworth TG, Furst DE, Strand V, Kempeni J, Fenner H, Lau CS, 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
  25. Singh G. Arthritis. Rheumatism and Aging Medical Information System Post-Marketing Surveillance Program. [ARAMIS-PMS] J Rheumatol. 2001;28:1174–1179
  26. Simon LS, Weaver AL, Graham DY, Kivitz AJ, Lipsky PE, Hubbard RC, et al. Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: a randomized controlled trial. JAMA. 1999;282:1921–1928
  27. Tubert-Bitter P, Manfredi R, Lellouch J, Begaud B. Sample size calculations for risk equivalence testing in pharmacoepidemiology. J Clin Epidemiol. 2000;1268–1274Dec:53
  28. Wells G, Beaton D, Shea B, Boers M, Simon L, Strand V, et al. Minimal clinically important differences: review of methods. J Rheumatol. 2001;28:406–412
  29. Boers M. NSAIDS and selective COX-2 inhibitors: competition between gastroprotection and cardioprotection. Lancet. 2001;357:1222–1223
  30. Ioannidis J, 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
  31. Sacristan JA, Gomez JC, Badia X, Kind P. Global index of safety (GIS): a new instrument to assess drug safety. J Clin Epidemiol. 2001;54:1120–1125
  32. Cook NR, Hebert PR, Manson JE, Buring JE, Hennekens CH. Self-selected posttrial aspirin use and subsequent cardiovascular disease and mortality in the physicians' health study. Arch Intern Med. 2000;160:921–928
  33. Beck RW, Chandler DL, Cole SR, Simon JH, Jacobs LD, Kinkel RP, et al. Interferon β-1a for early multiple sclerosis: CHAMPS trial subgroup analyses. Ann Neurol. 2002;51:481–490
  34. Blute ML, Bostwick DG, Seay TM, Martin SK, Slezak JM, Bergstralh EJ, et al. Pathologic classification of prostate carcinoma: the impact of margin status. Cancer. 1998;82:902–908
  35. Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993;36:729–740
  36. Cannon CP, Sharis PJ, Schweiger MJ, McCabe CH, Diver DJ, Shah PK, et al. Prospective validation of a composite endpoint in thrombolytic trials of acute myocardial infarction (TIMI 4 and 5). Thrombosis In Myocardial Infarction. Am J Cardiol. 1997;80:696–699

PII: S0895-4356(05)00109-5

doi: 10.1016/j.jclinepi.2004.11.028

Journal of Clinical Epidemiology
Volume 58, Issue 8 , Pages 785-790 , August 2005

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