Anne Rivelli , Osondi Ozoani-Lohrer , Cheryl Lefaiver , Maureen Shields , Andy Marek , Mercedes Robaina , Veronica Fitzpatrick
{"title":"患者参与由讲一种或多种英语以外语言的主要研究者进行的临床试验:探索作为语言替代物的种族","authors":"Anne Rivelli , Osondi Ozoani-Lohrer , Cheryl Lefaiver , Maureen Shields , Andy Marek , Mercedes Robaina , Veronica Fitzpatrick","doi":"10.1016/j.conctc.2024.101353","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English.</p></div><div><h3>Methods</h3><p>This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English.</p></div><div><h3>Results</h3><p>Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001).</p></div><div><h3>Conclusions</h3><p>Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101353"},"PeriodicalIF":1.4000,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001005/pdfft?md5=bb106c2f0283635499325954e4a043f0&pid=1-s2.0-S2451865424001005-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Patient participation in clinical trials conducted by principal investigators who speak one or more language(s) beyond english: Exploring ethnicity as proxy for language\",\"authors\":\"Anne Rivelli , Osondi Ozoani-Lohrer , Cheryl Lefaiver , Maureen Shields , Andy Marek , Mercedes Robaina , Veronica Fitzpatrick\",\"doi\":\"10.1016/j.conctc.2024.101353\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English.</p></div><div><h3>Methods</h3><p>This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English.</p></div><div><h3>Results</h3><p>Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001).</p></div><div><h3>Conclusions</h3><p>Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.</p></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":\"41 \",\"pages\":\"Article 101353\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-08-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2451865424001005/pdfft?md5=bb106c2f0283635499325954e4a043f0&pid=1-s2.0-S2451865424001005-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865424001005\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424001005","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Patient participation in clinical trials conducted by principal investigators who speak one or more language(s) beyond english: Exploring ethnicity as proxy for language
Background
To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English.
Methods
This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English.
Results
Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001).
Conclusions
Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.