Matches in SemOpenAlex for { <https://semopenalex.org/work/W4328114947> ?p ?o ?g. }
- W4328114947 abstract "Abstract Objective: Racial and ethnic minority groups are underrepresented in clinical research. Racially diverse individuals that speak languages other than English or have limited proficiency may be hindered from participation in randomized clinical trials (RCTs) through eligibility criteria. This study sought to assess English language requirements for enrollment in registered and published RCTs. Design: In a cross-sectional design, we searched for RCTs in the top 10 first-quartile general and internal medicine journals in 2017 on May 4, 2022, with at least one US site comparing heart disease, stroke, cancer, asthma, influenza and pneumonia, diabetes, HIV/AIDS, and COVID-19 drug interventions with standard or usual care or placebo with ClinicalTrials.gov registration and protocols. We assessed whether English or another language was required for trial enrollment in the eligibility criteria in protocols and ClinicalTrials.gov records. Good agreement was achieved by independent selection by two reviewers for inclusion (κ = 0.85; 95% CI, 0.75-0.95) and both the identification of language requirements and data extraction in RCTs (κ = 0.98; 95% CI, 0.87-1.00) from a sample of 50 RCTs. The primary outcome was the frequency of RCTs with English language requirements in eligibility criteria in protocols and ClinicalTrials.gov records by disease and funder type (industry funders had at least one industry funder, while non-industry funders had no industry funding). Secondary outcomes were readability of eligibility criteria in ClinicalTrials.gov records and reporting of race as a demographic variable. Readability was assessed with Flesch-Kincaid grade (FKG) level (ranges from grades 0 to 18 [college graduate]) and Gunning-Fog (GF) (ranges from grades 0 to 20 [college graduate]), where lower grades correspond to easier readability. Mann-Whitney tests compared readability with a 2-tailed P-value set at less than 0.05. Results: A total of 39 of 5995 RCTs from Annals of Internal Medicine (n = 2), JAMA (n = 14), JAMA Internal Medicine (n = 3), Lancet (n = 11), PLoS Medicine (n = 1), and New England Journal of Medicine (n = 8) were found. Trials mostly studied COVID-19 (n=18/39, 46%) and were industry-funded (n=23/39, 59%). The eligibility criteria in publications or ClinicalTrials.gov made no explicit statements about English or any other language required for enrollment. The lack of explicit statements about languages required for enrollment were common in both industry-funded (n=17/39, 44%) and non-industry funded (n=8/39, 21%) described in protocols. Eligibility criteria in protocols of 3 out of 39 (8%) non-industry funded RCTs restricted participation to English-speaking participants. Ten (26%) industry-funded and non-industry funded trials (both n=5/39, 13%) mentioned providing non-English languages. Participant race was reported in 37 (95%) articles and ClinicalTrials.gov records that comprised American Indian (median [interquartile range (IQR)], 1 [0-6]), Asian (14 [5-69]), Black (44 [36-100]), Latinx (45 [5-117]), Native Hawaiian (0 [0-1]), and White (229 [106-207]) participants. There were 17/39 (44%) RCTs with at least one difference in the reporting of race in the article and ClinicalTrials.gov. Eligibility criteria in protocols had a median (IQR) FKG of 11.5 (10.7-13.0) and GF of 13.0 (11.7-14.5) and in ClinicalTrials.gov, the median (IQR) FKG was 13.0 (11.0-14.0) and GF was 13.7 (IQR 11.7-14.7). In protocols, readability did not differ by funder (FKG for non-industry; 12.1 (11.4-13.3) vs. FKG for industry; 11.0 (10.3-12.6) and GF for non-industry; 13.4 (12.2-14.7) vs. GF for industry; 12.90 (11.6-14.5)), P=0.092 and, (P=0.567), respectively. In ClinicalTrials.gov, readability did not differ by funder (FKG for non-industry; 12.9 (11.7-13.9) vs. FKG for industry; 13.5 (10.7-14.6) and GF for non-industry; 14.5 (11.7-15.1) vs. GF for industry; 13.4 (12.2-15.7), P=0.575 and GF P=0.338, respectively. Conclusions: There was low explicit reporting of required languages in RCT eligibility criteria, and readability levels of eligibility criteria were low. Ethics committees and funders should obligate the inclusion of the explicit reporting of languages and high readability of information for participants. Accordingly, responsibility rests with ethics committees, funders, and trialists to conceive inclusive trials to strive toward health equity." @default.
- W4328114947 created "2023-03-22" @default.
- W4328114947 creator A5002607839 @default.
- W4328114947 creator A5015583629 @default.
- W4328114947 creator A5031804035 @default.
- W4328114947 creator A5043543988 @default.
- W4328114947 creator A5044937699 @default.
- W4328114947 creator A5057024921 @default.
- W4328114947 creator A5074971386 @default.
- W4328114947 date "2023-03-21" @default.
- W4328114947 modified "2023-09-28" @default.
- W4328114947 title "Inclusion in clinical research: cross-sectional study assessing potential barriers to informed consent in randomized controlled trials published in top general and internal medical journals" @default.
- W4328114947 cites W1805776597 @default.
- W4328114947 cites W1996880522 @default.
- W4328114947 cites W1997153955 @default.
- W4328114947 cites W2008501802 @default.
- W4328114947 cites W2022842093 @default.
- W4328114947 cites W2043990618 @default.
- W4328114947 cites W2122889339 @default.
- W4328114947 cites W2145216319 @default.
- W4328114947 cites W2147788997 @default.
- W4328114947 cites W2153361568 @default.
- W4328114947 cites W2158293741 @default.
- W4328114947 cites W2159865972 @default.
- W4328114947 cites W2160368247 @default.
- W4328114947 cites W2325391691 @default.
- W4328114947 cites W2401918641 @default.
- W4328114947 cites W2604259122 @default.
- W4328114947 cites W2738541296 @default.
- W4328114947 cites W2742133220 @default.
- W4328114947 cites W2747107882 @default.
- W4328114947 cites W2749929702 @default.
- W4328114947 cites W2752494178 @default.
- W4328114947 cites W2753489952 @default.
- W4328114947 cites W2896522583 @default.
- W4328114947 cites W2899917447 @default.
- W4328114947 cites W2901263658 @default.
- W4328114947 cites W2948953651 @default.
- W4328114947 cites W2973824785 @default.
- W4328114947 cites W2977132187 @default.
- W4328114947 cites W2984673963 @default.
- W4328114947 cites W2986540284 @default.
- W4328114947 cites W3029655136 @default.
- W4328114947 cites W3031602500 @default.
- W4328114947 cites W3032175876 @default.
- W4328114947 cites W3032373213 @default.
- W4328114947 cites W3032677067 @default.
- W4328114947 cites W3043308024 @default.
- W4328114947 cites W3080241308 @default.
- W4328114947 cites W3080718665 @default.
- W4328114947 cites W3080963011 @default.
- W4328114947 cites W3083313255 @default.
- W4328114947 cites W3084718121 @default.
- W4328114947 cites W3091148819 @default.
- W4328114947 cites W3093604087 @default.
- W4328114947 cites W3102453076 @default.
- W4328114947 cites W3102920585 @default.
- W4328114947 cites W3109999591 @default.
- W4328114947 cites W3111050887 @default.
- W4328114947 cites W3111123667 @default.
- W4328114947 cites W3112297031 @default.
- W4328114947 cites W3123497531 @default.
- W4328114947 cites W3125712166 @default.
- W4328114947 cites W3129869280 @default.
- W4328114947 cites W3135672007 @default.
- W4328114947 cites W3136726675 @default.
- W4328114947 cites W3142355365 @default.
- W4328114947 cites W3144575654 @default.
- W4328114947 cites W3151255356 @default.
- W4328114947 cites W3164832774 @default.
- W4328114947 cites W3177393241 @default.
- W4328114947 cites W3177953751 @default.
- W4328114947 cites W3199100532 @default.
- W4328114947 cites W3202637221 @default.
- W4328114947 cites W3206483794 @default.
- W4328114947 cites W3216029874 @default.
- W4328114947 cites W4210334206 @default.
- W4328114947 cites W4212988737 @default.
- W4328114947 cites W4223539866 @default.
- W4328114947 cites W4225396530 @default.
- W4328114947 cites W4226022025 @default.
- W4328114947 cites W4226523125 @default.
- W4328114947 cites W4230874191 @default.
- W4328114947 cites W4281737484 @default.
- W4328114947 cites W4285726101 @default.
- W4328114947 cites W4296777597 @default.
- W4328114947 doi "https://doi.org/10.21203/rs.3.rs-2665881/v1" @default.
- W4328114947 hasPublicationYear "2023" @default.
- W4328114947 type Work @default.
- W4328114947 citedByCount "0" @default.
- W4328114947 crossrefType "posted-content" @default.
- W4328114947 hasAuthorship W4328114947A5002607839 @default.
- W4328114947 hasAuthorship W4328114947A5015583629 @default.
- W4328114947 hasAuthorship W4328114947A5031804035 @default.
- W4328114947 hasAuthorship W4328114947A5043543988 @default.
- W4328114947 hasAuthorship W4328114947A5044937699 @default.
- W4328114947 hasAuthorship W4328114947A5057024921 @default.
- W4328114947 hasAuthorship W4328114947A5074971386 @default.
- W4328114947 hasBestOaLocation W43281149471 @default.
- W4328114947 hasConcept C126322002 @default.