Division of Orthopaedic Traumatology, Department of Orthopaedic Surgery, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, MC-7774, San Antonio, TX 78229. E-mail address for B.A. Zelle:
Division of Orthopaedics, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada.
J Bone Joint Surg Am. 2014 Apr 2;96(7):e56. doi: 10.2106/JBJS.M.00531.
Several orthopaedic studies have suggested patient race and ethnicity to be important predictors of patient functional outcomes. This issue has also been emphasized by federal funding sources. However, the reporting of race and ethnicity has gained little attention in the orthopaedic literature. The objective of this study was to determine the percentage of orthopaedic randomized controlled clinical trials in the United States that included race and ethnicity data and to record the racial and ethnic distribution of patients enrolled in these trials.
A systematic review of orthopaedic randomized controlled trials published from 2008 to 2011 was performed. The studies were identified through a manual search of thirty-two scientific journals, including all major orthopaedic journals as well as five leading medical journals. Only trials from the United States were included. The publication date, journal impact factor, orthopaedic subspecialty, ZIP code of the primary research site, number of enrolled patients, type of funding, and race and ethnicity of the study population were extracted from the identified studies.
A total of 158 randomized controlled trials with 37,625 enrolled patients matched the inclusion criteria. Only thirty-two studies (20.3%) included race or ethnicity with at least one descriptor. Government funding significantly increased the likelihood of reporting these factors (p < 0.05). The percentages of Hispanic and African-American patients were extractable for studies with 7648 and 6591 enrolled patients, respectively. In those studies, 4.6% (352) of the patients were Hispanic and 6.2% (410) were African-American; these proportions were 3.5-fold and twofold lower, respectively, than those represented in the 2010 United States Census.
Few orthopaedic randomized controlled trials performed in the United States reported data on race or ethnicity. Among trials that did report demographic race or ethnicity data, the inclusion of minority patients was substantially lower than would be expected on the basis of census demographics. Failure to represent the true racial diversity may result in decreased generalizability of trial conclusions across clinical populations.
一些骨科研究表明，患者的种族和民族是患者功能结果的重要预测因素。这一问题也受到联邦资金来源的强调。然而，骨科文献对种族和民族的报告却很少受到关注。本研究的目的是确定美国骨科随机对照临床试验中纳入种族和民族数据的比例，并记录这些试验中纳入的患者的种族和民族分布。
对 2008 年至 2011 年发表的骨科随机对照试验进行了系统回顾。通过对 32 种科学期刊（包括所有主要骨科期刊和 5 种领先的医学期刊）的手工搜索，确定了这些研究。仅纳入来自美国的试验。从确定的研究中提取了发表日期、期刊影响因子、骨科亚专科、主要研究地点的邮政编码、纳入患者人数、资金类型以及研究人群的种族和民族。
共有 158 项纳入 37625 名患者的随机对照试验符合纳入标准。只有 32 项研究（20.3%）至少有一个描述符纳入了种族或民族。政府资助显著增加了报告这些因素的可能性（p < 0.05）。在纳入 7648 名和 6591 名患者的研究中，可以提取西班牙裔和非裔美国人患者的比例。在这些研究中，4.6%（352 名）的患者为西班牙裔，6.2%（410 名）为非裔美国人；这些比例分别比 2010 年美国人口普查中代表的比例低 3.5 倍和 2 倍。
在美国进行的骨科随机对照试验中，很少有报告种族或民族数据。在报告人口统计学种族或民族数据的试验中，少数民族患者的纳入率明显低于人口普查人口统计学所预期的水平。未能代表真实的种族多样性可能会导致试验结论在临床人群中的普遍性降低。
