Yazici H
New York University
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Rheumatology | 2008
Yusuf Yazici; N. M. Adler; Yazici H
OBJECTIVES Many randomized clinical trials (RCTs) are labelled efficacy and safety while due consideration for power is provided only for efficacy outcomes. This in turn necessitates a discussion of the inadequacy of sample size (type II error) for identifying harm. This is particularly important in RCTs of TNF inhibitors as harm related to these agents is still a matter of debate. METHODS PubMed was searched for all RCTs published examining TNF inhibitors in RA, PsA and AS. Only original study reports were surveyed for whether: (i) they were labelled as efficacy, safety or both; (ii) the methods sections included safety as a primary or secondary end point; (iii) power calculations were adequately explained; (iv) statistical tests of significance were given for harm; and finally (v) any discussion of type II error for harm was present. RESULTS Of the 34 articles surveyed, 24 (71%) were labelled as efficacy and safety. Among these, 23 (96%) did not include safety as a formal primary or secondary end point. In only 2/24 (8%) power calculations were given for safety. Finally, in only 3/22 (14%) any discussion about the inadequate sample size (type II error) for detecting harm could be found. CONCLUSIONS Most reports of RCTs of TNF inhibitors in rheumatological diseases are inappropriately labelled as addressing efficacy and safety. Their lack of power in detecting harm is not adequately discussed, either.
The Journal of Rheumatology | 1988
Sebahattin Yurdakul; Günaydin I; Yalçın Tüzün; N Tankurt; Pazarli H; Yilmaz Ozyazgan; Yazici H
The Journal of Rheumatology | 1980
Yazici H; Yalçın Tüzün; Pazarli H; Yalcin B; Sebahattin Yurdakul; Müftüoglu A
Clinical and Experimental Rheumatology | 2004
Doruk Erkan; Yusuf Yazici; Abraham Sanders; Trost D; Yazici H
Clinical and Experimental Rheumatology | 1985
Yazici H; Yalçın Tüzün; Tanman Ab; Sebahattin Yurdakul; Server Serdaroğlu; Pazarli H; Müftüoglu A
Rheumatology | 2001
Melike Melikoglu; M. R. Altıparmak; Izzet Fresko; R. Tunç; Sebahattin Yurdakul; Vedat Hamuryudan; Yazici H
Clinical and Experimental Rheumatology | 2005
Feride Gogus; Yusuf Yazici; Yazici H
Clinical and Experimental Rheumatology | 2005
Sebahattin Yurdakul; N. Hekim; T. Soysal; Izzet Fresko; I. Bavunoglu; Fatma Ozbakir; F. Tabak; Melike Melikoglu; Vedat Hamuryudan; Yazici H
The Journal of Rheumatology | 1998
Yavuz S; Izzet Fresko; Hamuryudan; Sebahattin Yurdakul; Yazici H
Clinical and Experimental Rheumatology | 1987
Fatma Ozbakir; Yazici H; Cem Mat; Yalçın Tüzün; Sebahattin Yurdakul; Yilmazer S