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To the Editor:

We read with great interest the study by Simsek and Yazici published recently in Arthritis Care & Research describing the incomplete reporting of recruitment information for rheumatoid arthritis (RA) patients in clinical trials of biologic agents (1). We agree with the authors' assessment that the inadequacy of information on the recruitment process limits the reader's ability to assess the external validity of the findings.

We would also like to highlight other important limitations in the reporting of clinical trial results of biologic agents in RA that compromise the generalizability of the findings to individual patients. Whereas participant age and sex are uniformly reported, information concerning race and ethnicity is inconsistently reported despite emerging evidence of disparities in outcomes among minority patients (2). To support this observation, we performed a systematic review of 76 published clinical trials of biologic agents from 1999 to 2012 and found that 29 (38%) of the 76 trials reported on the proportion of patients who were white versus nonwhite, and only 11 (14%) of the 76 trials reported on race or ethnic subgroups. Similar trends have been observed in other reviews of clinical trials from the general medical literature (3).

It should be further emphasized that reporting of other patient characteristics reflecting socioeconomic status, such as employment status and household income, would be helpful to improve the interpretability of results (4). These indices were previously found to significantly impact patient outcomes in several diseases, including RA (5). Exclusion of these types of data points may hinder a clinician's ability to determine whether the findings of a particular study are applicable to individual patients.

As pointed out by Simsek and Yazici, consensus statements such as the Consolidated Standards of Reporting Trials offer guidance regarding the reporting of results, although the original guidelines do not specifically address the reporting of race and ethnicity (6). We believe that increased reporting of patient demographic information, particularly race and ethnicity, could shed light on the reasons for the disparities in outcomes seen in minority patients in clinical practice (7). This increased reporting will also improve the interpretability of results from trials of biologic agents in RA to specific patient populations and clarify the generalizability of these results for our increasingly diverse patient population.

  • 1
    Simsek I, Yazici Y. Incomplete reporting of recruitment information in clinical trials of biologic agents for the treatment of rheumatoid arthritis: a review. Arthritis Care Res (Hoboken) 2012; 64: 16116.
  • 2
    Bruce B, Fries JF, Murtagh KN. Health status disparities in ethnic minority patients with rheumatoid arthritis: a cross-sectional study. J Rheumatol 2007; 34: 14759.
  • 3
    Hussain-Gambles M, Atkin K, Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc Care Community 2004; 12: 3828.
  • 4
    Furler J, Magin P, Pirotta M, van Driel M. Participant demographics reported in “Table 1” of randomised controlled trials: a case of “inverse evidence”? Int J Equity Health 2012; 11: 14.
  • 5
    Harrison MJ, Farragher TM, Clarke AM, Manning SC, Bunn DK, Symmons DP. Association of functional outcome with both personal- and area-level socioeconomic inequalities in patients with inflammatory polyarthritis. Arthritis Rheum 2009; 61: 1297304.
  • 6
    Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 6379.
  • 7
    Barton JL, Trupin L, Schillinger D, Gansky SA, Tonner C, Margaretten M, et al. Racial and ethnic disparities in disease activity and function among persons with rheumatoid arthritis from university-affiliated clinics. Arthritis Care Res (Hoboken) 2011; 63: 123846.

Jeffrey Potter MD*, Tanya Spruill PhD*, Jeffrey D. Greenberg MD, MPH*, * New York University School of Medicine, New York, NY.