Representation of Race and Ethnicity in Randomized Clinical Trials of Diabetic Macular Edema and Retinal Vein Occlusion Compared to 2010 US Census Data
Representation of Race and Ethnicity in Randomized Clinical Trials of Diabetic Macular Edema and Retinal Vein Occlusion Compared to 2010 US Census Data
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DOI：
10.1001/jamaophthalmol.2022.3929
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发表时间：
2022-10-06
影响因子：
8.1
通讯作者：
Rachitskaya, Aleksandra
中科院分区：
文献类型：
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作者：
Kaakour, Abdul-Hadi;Hua, Hong-Uyen;Rachitskaya, Aleksandra
目的比较糖尿病性黄斑水肿（DME）和视网膜静脉阻塞性黄斑水肿（RVO）的随机临床试验（RCT）与美国人口普查数据的种族和民族分布情况。这是一项横断面回顾性分析，比较了2004年至2020年美国DME和RVO RCT的种族和民族人口统计学特征与2010年美国人口普查数据。检索PubMed和ClinicalTrials.gov，以筛选已完成的3期RCT和已发表的结果。在筛选的169项试验中，146项被排除，因为它们不完整，没有报告人种和种族，或者不在美国。共纳入23项试验（DME 15项，RVO 8项）。在每个RCT中记录了美国印第安人或阿拉斯加原住民、亚洲人、黑人、西班牙裔、夏威夷原住民或其他太平洋岛民以及白色受试者的数量和百分比。人口分布和比例与2010年美国人口普查报告的分布和比例进行比较，使用卡方检验（2）。主要结果和测量结果在视网膜血管疾病RCT的种族和民族人群中，代表性过高、代表性不足或代表性与2010年美国人口普查数据相称。共有38名参与者（0.4%）被认为是美国印第安人或阿拉斯加原住民和夏威夷原住民或其他太平洋岛民（因人数少而合并），415名亚洲参与者（4.4%），904名黑人参与者（9.6%），954名西班牙裔参与者（10.1%）和7613名白色参与者（80.4%）。相比之下，2010年美国人口普查数据显示，1.1%的美国人口自报为美洲印第安人或阿拉斯加原住民和夏威夷原住民或其他太平洋岛民（本研究中合并进行比较），4.8%自报为亚洲人，12.6%为黑人或非洲裔美国人，16.3%为西班牙裔，63.7%为白色。美洲印第安人或阿拉斯加原住民和夏威夷人或其他太平洋岛民参与者在2项试验中代表性不足，在20项试验中既没有代表性过高也没有代表性不足，在任何纳入的试验中也没有代表性过高。亚洲参与者在10项试验中代表性不足，在4项试验中代表性过高，在8项试验中既不代表性过高也不代表性不足。黑人参与者在9项试验中代表性不足，在2项试验中代表性过高。在11个国家中任职人数既不偏高也不偏低。西班牙裔参与者在15项试验中代表性不足，在2项试验中代表性过高，在5项试验中既不代表性过高也不代表性不足。白色参与者在2项试验中代表性不足，在14项试验中代表性过高，在7项试验中既不代表性过高也不代表性不足。比较RCT人口分布与美国2010年人口普查数据的卡方（2）值在23个纳入的RCTs.CONCLUSIONS和RELEVANCE中的22个中存在显著差异本研究的结果表明，根据2010年人口普查，DME和RVO的RCT与美国人口的种族和民族人口统计数据之间存在差异。白色研究参与者最常代表性过高，西班牙裔研究参与者最常代表性不足。这些研究结果支持需要更多的努力，招募代表性不足的种族和族裔少数，以提高外部效度的试验结果。
IMPORTANCE Diverse enrollment and adequate representation of racial and ethnic minority groups in randomized clinical trials (RCTs) are valuable to ensure external validity and applicability of results.OBJECTIVE To compare the distribution of race and ethnicity in RCTs of diabetic macular edema (DME) and macular edema from retinal vein occlusion (RVO) to that of US Census data.DESIGN, SETTING, AND PARTICIPANTS This was a cross-sectional retrospective analysis comparing racial and ethnic demographic characteristics of US-based RCTs of DME and RVO between 2004 and 2020 with 2010 US Census data. PubMed and ClinicalTrials.gov were searched to screen for completed phase 3 RCTs with published results. Of 169 trials screened, 146 were excluded because they were incomplete, did not report race and ethnicity, or were not based in the US. and 23 trials were included (15 DME and 8 RVO). The number and percentage of American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Other Pacific Islander, and White participants was recorded in each RCT. The demographic distribution and proportion was compared to the reported distribution and proportion in the 2010 US Census using the chi(2) test.MAIN OUTCOMES AND MEASURES Overrepresentation, underrepresentation, or representation commensurate with 2010 US Census data in the racial and ethnic populations of RCTs of retinal vascular disease.RESULTS In 23 included RCTs of DME and RVO, there were a total of 38 participants (0.4%) who identified as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined owing to small numbers), 415 Asian participants (4.4%), 904 Black participants (9.6%), 954 Hispanic participants (10.1%), and 7613 White participants (80.4%). By comparison, the 2010 US Census data indicated that 1.1% of the US population self-reported as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined for comparison in this study), 4.8% self-reported as Asian, 12.6% as Black or African American, 16.3% as Hispanic, and 63.7% as White. American Indian or Alaska Native and Hawaiian or Other Pacific Islander participants were underrepresented in 2 trials, neither overrepresented nor underrepresented in 20, and not overrepresented in any of the included trials. Asian participants were underrepresented in 10 trials, overrepresented in 4, and neither overrepresented nor underrepresented in 8. Black participants were underrepresented in 9 trials, overrepresented in 2. and neither overrepresented nor underrepresented in 11. Hispanic participants were underrepresented in 15 trials, overrepresented in 2, and neither overrepresented nor underrepresented in 5. White participants were underrepresented in 2 trials, overrepresented in 14, and neither overrepresented nor underrepresented in 7. The chi(2) values comparing RCT demographic distribution to US 2010 Census data were significantly different in 22 of 23 included RCTs.CONCLUSIONS AND RELEVANCE The findings in this study indicated a discrepancy between racial and ethnic demographic data in RCTs of DME and RVO and the US population according to the 2010 Census. White study participants were most frequently overrepresented, and Hispanic study participants were most frequently underrepresented. These findings support the need for more efforts to recruit underrepresented racial and ethnic minorities to improve external validity in trial findings.