A survey of inclusion of the time element when reporting adverse effects in randomized controlled trials of cyclooxygenase-2 and tumor necrosis factor alpha inhibitors

Yusuf Yazici ^1* and Hasan Yazici ²

¹ NYU Hospital for Joint Diseases, United States
² Istanbul University, Turkey

^* To whom correspondence should be addressed. E-mail: yusuf.yazici{at}nyumc.org.

Accepted 26 June 2006

Abstract

Background: We surveyed the adequacy of reporting the time element in adverse effects in randomized clinical trial articles of cyclooxygenase-2 and tumor necrosis factor alpha antagonists.

Methods: A search in prominent rheumatology and general/internal medicine journals for all randomized controlled trials published about cyclooxygenase-2 and tumor necrosis factor alpha inhibitor use in rheumatologic diseases up to November 2005 was conducted. Reporting of time to the occurrence of the adverse effects, the use of patient - years as the time frame of the reported adverse effects and the utilization of annual standard incidence ratios based on SEER (Surveillance, Epidemiology, and End-Results) program when reporting neoplasms as potential adverse effects of tumor necrosis factor alpha antagonists were specifically tabulated.

Results: Only 23/70 (33%) of all articles gave the specific time of onset of an adverse effect. Nine studies used patient - years in reporting the adverse effects and 6 studies used annual standard incidence ratios, using SEER, as the comparator.

Conclusion: In reporting of adverse effects in randomized clinical trials, a particularly neglected issue is the reporting of the time dimension of adverse effects.

Keywords: adverse effects, patient years, randomized clinical trial, rheumatoid arthritis, time to event

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?