Silvestre Jason, Ahn Jaimo, Harris Mitchel B, Hartsock Langdon A, Slobogean Gerard P
Medical University of South Carolina, Charleston, SC, United States.
University of Michigan Medical School, Ann Arbor, MI, United States.
Injury. 2025 Jul;56(7):112413. doi: 10.1016/j.injury.2025.112413. Epub 2025 May 6.
The impact of social determinants on clinical outcomes following surgeries for orthopaedic injuries are well-documented. In this study, we sought to quantify the representation of women, racial, and ethnic minorities in US-based clinical trials for hip fracture surgery.
This was a cross-sectional analysis of patients enrolled in US-based, interventional clinical trials for hip fractures registered on ClinicalTrials.gov (2000-2022). Participation-to-prevalence ratios (PPRs) were calculated for demographic groups in clinical trials relative to their prevalence among patients receiving hip fracture surgery in the National Inpatient Sample (2006-2015). PPRs between 0.8-1.2 were considered equitable representation. PPRs<0.8 were considered underrepresentation and PPRs>1.2 were considered overrepresentation. Temporal trends were analyzed between previous (2000-2010) and contemporary (2011-2022) periods.
There were thirty-eight hip fracture clinical trials involving 6937 participants included in this study. All clinical trials reported sex, but only sixteen trials (42 %) reported race and ten trials (26 %) reported ethnicity. In total, trial participants were predominately White (89.3 %) and female (68.0 %). Few patients were non-White including Asian (7.2 %), Black (2.1 %), and Hispanic (0.8 %). Female (PPR=0.97) and male (PPR=1.07) patients had equitable representation. However, Hispanic (PPR=0.22), and African American (PPR=0.51) patients were underrepresented. White patients (PPR=1.00) had equitable representation while Asian patients were overrepresented (PPR=4.50). The rate of race (P < 0.001) and ethnicity (P = 0.010) reporting increased between previous and contemporary periods.
Recruitment of racial and ethnic minorities into hip fracture clinical trials remains limited. The impact of social determinants on outcomes after trauma surgery requires equitable representation of all groups in clinical trials to ensure translatability of results. Stakeholders across healthcare, industry, and government must work to address these disparities.
社会决定因素对骨科损伤手术后临床结果的影响已有充分记录。在本研究中，我们试图量化美国髋部骨折手术临床试验中女性、种族和少数民族的代表性。
这是一项对在ClinicalTrials.gov上注册的美国髋部骨折介入性临床试验的患者进行的横断面分析（2000 - 2022年）。计算了临床试验中各人口统计学组相对于其在美国国家住院样本（2006 - 2015年）中接受髋部骨折手术患者中的患病率的参与率与患病率之比（PPR）。PPR在0.8 - 1.2之间被认为是公平代表性。PPR < 0.8被认为代表性不足，PPR > 1.2被认为代表性过高。分析了之前（2000 - 2010年）和当代（2011 - 2022年）期间的时间趋势。
本研究纳入了38项髋部骨折临床试验，涉及6937名参与者。所有临床试验都报告了性别，但只有16项试验（42%）报告了种族，10项试验（26%）报告了民族。总体而言，试验参与者主要是白人（89.3%）和女性（68.0%）。非白人患者很少，包括亚洲人（7.2%）、黑人（2.1%）和西班牙裔（0.8%）。女性（PPR = 0.97）和男性（PPR = 1.07）患者具有公平代表性。然而，西班牙裔（PPR = 0.22）和非裔美国患者（PPR = 0.51）代表性不足。白人患者（PPR = 1.00）具有公平代表性，而亚洲患者代表性过高（PPR = 4.50）。在之前和当代期间，种族（P < 0.001）和民族（P = 0.010）报告率有所增加。
种族和少数民族参与髋部骨折临床试验的情况仍然有限。社会决定因素对创伤手术后结果的影响要求临床试验中所有群体都有公平的代表性，以确保结果的可转化性。医疗保健、行业和政府的利益相关者必须努力解决这些差异。
