Eric Solomon, Mihir Gupta, Rachel Su, Nolan Reinhart, Valentina Battistoni, Aditya Mittal, Rachel S Bronheim, Juan Silva-Aponte, Miguel Cartagena Reyes, Devan Hawkins, Aditya Joshi, Khaled M Kebaish, Hamid Hassanzadeh
{"title":"脊柱外科随机临床试验中种族、民族和健康社会决定因素的趋势和报告率：系统回顾","authors":"Eric Solomon, Mihir Gupta, Rachel Su, Nolan Reinhart, Valentina Battistoni, Aditya Mittal, Rachel S Bronheim, Juan Silva-Aponte, Miguel Cartagena Reyes, Devan Hawkins, Aditya Joshi, Khaled M Kebaish, Hamid Hassanzadeh","doi":"10.1097/BSD.0000000000001675","DOIUrl":null,"url":null,"abstract":"<p><strong>Study design: </strong>A systematic review.</p><p><strong>Objective: </strong>We characterized the rates of sociodemographic data and social determinants of health (SDOH) reported in spinal surgery randomized control trials (RCTs) and the association between these RCTs' characteristics and their rates of reporting on race, ethnicity, and SDOH variables.</p><p><strong>Summary of background data: </strong>Although numerous institutions maintain guidelines and recommendations regarding the inclusion and reporting of sociodemographic and SDOH variables in RCTs, the proportion of studies that ultimately report such information is unclear, particularly in spine surgery.</p><p><strong>Materials and methods: </strong>We searched the MEDLINE, PubMed, and Embase databases for published results from spinal surgery RCTs from January 2002 through December 2022, and screened studies according to prespecified inclusion criteria regarding analysis and reporting of sociodemographic and SDOH variables.</p><p><strong>Results: </strong>We analyzed 421 studies. Ninety-six studies (22.8%) reported race, ethnicity, or SDOH covariates. On multivariate analysis, study size [rate ratio (RR)=1.18; 95% CI, 1.06-1.32], public/institutional funding (RR=2.28; 95% CI, 1.29-4.04), and private funding (RR=3.27; 95% CI, 1.87-5.74) were significantly associated with reporting race, ethnicity, or SDOH variables. Study size (RR=1.26; 95% CI, 1.07-1.48) and North American region (RR=21.84; CI, 5.04-94.64) were associated with a higher probability of reporting race and/or ethnicity. Finally, study size (RR=1.27; 95% CI, 1.10-1.46), public/institutional funding (RR=2.68; 95% CI, 1.33-5.39), focus on rehabilitation/therapy intervention (RR=2.70; 95% CI, 1.40-5.21), and nonblinded study groups (RR=2.70; 95% CI, 1.40-5.21) were associated with significantly higher probability of reporting employment status.</p><p><strong>Conclusion: </strong>Rates of reporting race, ethnicity, and SDOH variables were lower in the spinal surgery RCTs in our study than in RCTs in other medical disciplines. These reporting rates did not increase over a 20-year period. Trial characteristics significantly associated with higher rates of reporting were larger study size, North American region, private or public funding, and a focus on behavioral/rehabilitation interventions.</p><p><strong>Level of evidence: </strong>Level III.</p>","PeriodicalId":10457,"journal":{"name":"Clinical Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Trends and Rates of Reporting of Race, Ethnicity, and Social Determinants of Health in Spine Surgery Randomized Clinical Trials: A Systematic Review.\",\"authors\":\"Eric Solomon, Mihir Gupta, Rachel Su, Nolan Reinhart, Valentina Battistoni, Aditya Mittal, Rachel S Bronheim, Juan Silva-Aponte, Miguel Cartagena Reyes, Devan Hawkins, Aditya Joshi, Khaled M Kebaish, Hamid Hassanzadeh\",\"doi\":\"10.1097/BSD.0000000000001675\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Study design: </strong>A systematic review.</p><p><strong>Objective: </strong>We characterized the rates of sociodemographic data and social determinants of health (SDOH) reported in spinal surgery randomized control trials (RCTs) and the association between these RCTs' characteristics and their rates of reporting on race, ethnicity, and SDOH variables.</p><p><strong>Summary of background data: </strong>Although numerous institutions maintain guidelines and recommendations regarding the inclusion and reporting of sociodemographic and SDOH variables in RCTs, the proportion of studies that ultimately report such information is unclear, particularly in spine surgery.</p><p><strong>Materials and methods: </strong>We searched the MEDLINE, PubMed, and Embase databases for published results from spinal surgery RCTs from January 2002 through December 2022, and screened studies according to prespecified inclusion criteria regarding analysis and reporting of sociodemographic and SDOH variables.</p><p><strong>Results: </strong>We analyzed 421 studies. Ninety-six studies (22.8%) reported race, ethnicity, or SDOH covariates. On multivariate analysis, study size [rate ratio (RR)=1.18; 95% CI, 1.06-1.32], public/institutional funding (RR=2.28; 95% CI, 1.29-4.04), and private funding (RR=3.27; 95% CI, 1.87-5.74) were significantly associated with reporting race, ethnicity, or SDOH variables. Study size (RR=1.26; 95% CI, 1.07-1.48) and North American region (RR=21.84; CI, 5.04-94.64) were associated with a higher probability of reporting race and/or ethnicity. Finally, study size (RR=1.27; 95% CI, 1.10-1.46), public/institutional funding (RR=2.68; 95% CI, 1.33-5.39), focus on rehabilitation/therapy intervention (RR=2.70; 95% CI, 1.40-5.21), and nonblinded study groups (RR=2.70; 95% CI, 1.40-5.21) were associated with significantly higher probability of reporting employment status.</p><p><strong>Conclusion: </strong>Rates of reporting race, ethnicity, and SDOH variables were lower in the spinal surgery RCTs in our study than in RCTs in other medical disciplines. These reporting rates did not increase over a 20-year period. Trial characteristics significantly associated with higher rates of reporting were larger study size, North American region, private or public funding, and a focus on behavioral/rehabilitation interventions.</p><p><strong>Level of evidence: </strong>Level III.</p>\",\"PeriodicalId\":10457,\"journal\":{\"name\":\"Clinical Spine Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2024-09-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Spine Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/BSD.0000000000001675\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Spine Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/BSD.0000000000001675","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Trends and Rates of Reporting of Race, Ethnicity, and Social Determinants of Health in Spine Surgery Randomized Clinical Trials: A Systematic Review.
Study design: A systematic review.
Objective: We characterized the rates of sociodemographic data and social determinants of health (SDOH) reported in spinal surgery randomized control trials (RCTs) and the association between these RCTs' characteristics and their rates of reporting on race, ethnicity, and SDOH variables.
Summary of background data: Although numerous institutions maintain guidelines and recommendations regarding the inclusion and reporting of sociodemographic and SDOH variables in RCTs, the proportion of studies that ultimately report such information is unclear, particularly in spine surgery.
Materials and methods: We searched the MEDLINE, PubMed, and Embase databases for published results from spinal surgery RCTs from January 2002 through December 2022, and screened studies according to prespecified inclusion criteria regarding analysis and reporting of sociodemographic and SDOH variables.
Results: We analyzed 421 studies. Ninety-six studies (22.8%) reported race, ethnicity, or SDOH covariates. On multivariate analysis, study size [rate ratio (RR)=1.18; 95% CI, 1.06-1.32], public/institutional funding (RR=2.28; 95% CI, 1.29-4.04), and private funding (RR=3.27; 95% CI, 1.87-5.74) were significantly associated with reporting race, ethnicity, or SDOH variables. Study size (RR=1.26; 95% CI, 1.07-1.48) and North American region (RR=21.84; CI, 5.04-94.64) were associated with a higher probability of reporting race and/or ethnicity. Finally, study size (RR=1.27; 95% CI, 1.10-1.46), public/institutional funding (RR=2.68; 95% CI, 1.33-5.39), focus on rehabilitation/therapy intervention (RR=2.70; 95% CI, 1.40-5.21), and nonblinded study groups (RR=2.70; 95% CI, 1.40-5.21) were associated with significantly higher probability of reporting employment status.
Conclusion: Rates of reporting race, ethnicity, and SDOH variables were lower in the spinal surgery RCTs in our study than in RCTs in other medical disciplines. These reporting rates did not increase over a 20-year period. Trial characteristics significantly associated with higher rates of reporting were larger study size, North American region, private or public funding, and a focus on behavioral/rehabilitation interventions.
期刊介绍：
Clinical Spine Surgery is the ideal journal for the busy practicing spine surgeon or trainee, as it is the only journal necessary to keep up to date with new clinical research and surgical techniques. Readers get to watch leaders in the field debate controversial topics in a new controversies section, and gain access to evidence-based reviews of important pathologies in the systematic reviews section. The journal features a surgical technique complete with a video, and a tips and tricks section that allows surgeons to review the important steps prior to a complex procedure.
Clinical Spine Surgery provides readers with primary research studies, specifically level 1, 2 and 3 studies, ensuring that articles that may actually change a surgeon’s practice will be read and published. Each issue includes a brief article that will help a surgeon better understand the business of healthcare, as well as an article that will help a surgeon understand how to interpret increasingly complex research methodology. Clinical Spine Surgery is your single source for up-to-date, evidence-based recommendations for spine care.
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