Racial disparities in nonalcoholic fatty liver disease clinical trial enrollment: A systematic review and meta-analysis
| العنوان: | Racial disparities in nonalcoholic fatty liver disease clinical trial enrollment: A systematic review and meta-analysis |
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| المؤلفون: | Parita Patel, Charles Muller, Sonali Paul |
| المصدر: | World Journal of Hepatology |
| بيانات النشر: | Baishideng Publishing Group Inc., 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, Hepatology, business.industry, Hispanic, medicine.disease, Clinical trial, 03 medical and health sciences, fluids and secretions, 0302 clinical medicine, 030220 oncology & carcinogenesis, Meta-analysis, Internal medicine, parasitic diseases, Nonalcoholic fatty liver disease, medicine, 030211 gastroenterology & hepatology, Racial disparities, business, Non-alcoholic steatohepatitis, Meta-Analysis, Non-alcoholic fatty liver disease |
| الوصف: | BACKGROUND Non-alcoholic fatty liver disease (NAFLD) has a heterogeneous distribution across racial and ethnic groups, with a disproportionate burden among Hispanics. Although there are currently no approved therapies for treatment of NAFLD, several therapies have been investigated in clinical trials. AIM To analyze the inclusion of racial and ethnic minority groups in clinical trials for NAFLD. METHODS We performed a systematic review of North American, English-language, prospective studies for NAFLD therapies published from 2005 to 2019. Racial and ethnic enrollment data were recorded for each eligible study. Meta-analysis was performed to compute pooled prevalence of different racial and ethnic groups, followed by further subgroup analyses. These analyses were based on diagnosis of non-alcoholic steatohepatitis (NASH) and timing of study on enrollment by ethnicity. Descriptive statistics were performed to compare racial and ethnic study enrollment to previously reported NAFLD population prevalence. RESULTS Thirty-eight studies met criteria for inclusion in the systematic review. When reported, median age of enrolled subjects was 49 years (range 41.5-58) with 56% female participants. NAFLD was defined through biopsy findings in 79% (n = 30) of the studies. Of the included articles, treatment modalities ranged from medications (n = 28, 74%), lifestyle interventions (n = 5, 13%), bariatric surgery (n = 4, 11%) and phlebotomy (n = 1, 2%). Twenty-eight studies (73%) included racial and/or ethnic demographic information, while only 17 (45%) included information regarding Hispanic participation. Of the 2983 patients enrolled in all eligible trials, a total of only 346 (11.6%) Hispanic participants was reported. Meta-analysis revealed a pooled Hispanic prevalence of 24.3% (95% confidence interval 16.6-32.0, I2 94.6%) among studies documenting Hispanic enrollment. Hispanic enrollment increased over time from 15% from 2005-2014 to 37% from 2015-2019. CONCLUSION In a meta-analysis of NAFLD trials, documentation of racial/ethnic demographic data occurred in less than half of studies. Standardization of reporting of race/ethnicity and targeted interventions toward minority recruitment are needed to improve diversity of enrollment. |
| تدمد: | 1948-5182 2005-2014 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::59b3fc450c026fd3025bb1d038872e80 https://doi.org/10.4254/wjh.v12.i8.506 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....59b3fc450c026fd3025bb1d038872e80 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19485182 20052014 |
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