Sean W X Ong, Christina Blagojevic, Aliya Bryce, Aaron Ovadia, Matthew Slater, Daire Pryal, Rodrigo Escobar Careaga, Hadrien Moffroid, Arvind Yerramilli, Esmita Charani, Nick Daneman, Steven Y C Tong
{"title":"传染病临床试验参与者的社会人口学特征报告——系统综述","authors":"Sean W X Ong, Christina Blagojevic, Aliya Bryce, Aaron Ovadia, Matthew Slater, Daire Pryal, Rodrigo Escobar Careaga, Hadrien Moffroid, Arvind Yerramilli, Esmita Charani, Nick Daneman, Steven Y C Tong","doi":"10.1016/j.cmi.2025.04.030","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Reporting of demographic characteristics in randomized clinical trials (RCTs) is recommended to facilitate assessment of generalizability to other populations. However, there is a lack of consensus as to what variables should be reported, and there are limited data describing current research practice.</p><p><strong>Objectives: </strong>We aimed to evaluate reporting of sociodemographic characteristics of participants in infectious diseases RCTs and identify gaps in current practice.</p><p><strong>Methods: </strong>We conducted a systematic review of all infectious diseases-related RCTs published between January 2014 and August 2023 in ten selected high-impact journals by searching the Ovid MEDLINE database. Outcomes of interest were the reporting of five patient-level sociodemographic characteristics, as recommended by the CONSORT-Equity 2017 extension to the CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines: (a) ethnicity, (b) sex and/or gender, (c) education level, (d) socioeconomic status (SES), and (e) rurality. We summarized descriptive results for the reporting of each characteristic overall, by trial type (health equity-related vs. non-health equity-related), subject area, and year of publication. We fitted multivariable logistic regression models to identify trial characteristics associated with the reporting of each characteristic. Risk of bias of trials was not assessed as our objective was to assess trial reporting and not results.</p><p><strong>Results: </strong>We screened 4234 articles and included 1343. Almost all trials (1201/1233, 97.4%) reported sex and/or gender. In contrast, less than half (654/1326, 49.3%) reported ethnicity, and only a minority reported education level (113/1252, 9.0%), SES (120/1340, 9.0%), and rurality (45/1269, 3.9%). There was no improvement in reporting of each characteristic over the 10-year period. Subject area, funding source, whether a trial was health equity-related, use of a medical writer, and trial setting (high vs. low/middle-income country) were significantly associated with the reporting of ethnicity, education level, and SES.</p><p><strong>Conclusions: </strong>Reporting of sociodemographic characteristics in infectious diseases RCTs is inconsistent and has not improved over time.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9000,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Reporting of sociodemographic characteristics of trial participants in infectious diseases clinical trials-a systematic review.\",\"authors\":\"Sean W X Ong, Christina Blagojevic, Aliya Bryce, Aaron Ovadia, Matthew Slater, Daire Pryal, Rodrigo Escobar Careaga, Hadrien Moffroid, Arvind Yerramilli, Esmita Charani, Nick Daneman, Steven Y C Tong\",\"doi\":\"10.1016/j.cmi.2025.04.030\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Reporting of demographic characteristics in randomized clinical trials (RCTs) is recommended to facilitate assessment of generalizability to other populations. However, there is a lack of consensus as to what variables should be reported, and there are limited data describing current research practice.</p><p><strong>Objectives: </strong>We aimed to evaluate reporting of sociodemographic characteristics of participants in infectious diseases RCTs and identify gaps in current practice.</p><p><strong>Methods: </strong>We conducted a systematic review of all infectious diseases-related RCTs published between January 2014 and August 2023 in ten selected high-impact journals by searching the Ovid MEDLINE database. Outcomes of interest were the reporting of five patient-level sociodemographic characteristics, as recommended by the CONSORT-Equity 2017 extension to the CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines: (a) ethnicity, (b) sex and/or gender, (c) education level, (d) socioeconomic status (SES), and (e) rurality. We summarized descriptive results for the reporting of each characteristic overall, by trial type (health equity-related vs. non-health equity-related), subject area, and year of publication. We fitted multivariable logistic regression models to identify trial characteristics associated with the reporting of each characteristic. Risk of bias of trials was not assessed as our objective was to assess trial reporting and not results.</p><p><strong>Results: </strong>We screened 4234 articles and included 1343. Almost all trials (1201/1233, 97.4%) reported sex and/or gender. In contrast, less than half (654/1326, 49.3%) reported ethnicity, and only a minority reported education level (113/1252, 9.0%), SES (120/1340, 9.0%), and rurality (45/1269, 3.9%). There was no improvement in reporting of each characteristic over the 10-year period. Subject area, funding source, whether a trial was health equity-related, use of a medical writer, and trial setting (high vs. low/middle-income country) were significantly associated with the reporting of ethnicity, education level, and SES.</p><p><strong>Conclusions: </strong>Reporting of sociodemographic characteristics in infectious diseases RCTs is inconsistent and has not improved over time.</p>\",\"PeriodicalId\":10444,\"journal\":{\"name\":\"Clinical Microbiology and Infection\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":10.9000,\"publicationDate\":\"2025-05-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Microbiology and Infection\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cmi.2025.04.030\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Microbiology and Infection","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cmi.2025.04.030","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Reporting of sociodemographic characteristics of trial participants in infectious diseases clinical trials-a systematic review.
Background: Reporting of demographic characteristics in randomized clinical trials (RCTs) is recommended to facilitate assessment of generalizability to other populations. However, there is a lack of consensus as to what variables should be reported, and there are limited data describing current research practice.
Objectives: We aimed to evaluate reporting of sociodemographic characteristics of participants in infectious diseases RCTs and identify gaps in current practice.
Methods: We conducted a systematic review of all infectious diseases-related RCTs published between January 2014 and August 2023 in ten selected high-impact journals by searching the Ovid MEDLINE database. Outcomes of interest were the reporting of five patient-level sociodemographic characteristics, as recommended by the CONSORT-Equity 2017 extension to the CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines: (a) ethnicity, (b) sex and/or gender, (c) education level, (d) socioeconomic status (SES), and (e) rurality. We summarized descriptive results for the reporting of each characteristic overall, by trial type (health equity-related vs. non-health equity-related), subject area, and year of publication. We fitted multivariable logistic regression models to identify trial characteristics associated with the reporting of each characteristic. Risk of bias of trials was not assessed as our objective was to assess trial reporting and not results.
Results: We screened 4234 articles and included 1343. Almost all trials (1201/1233, 97.4%) reported sex and/or gender. In contrast, less than half (654/1326, 49.3%) reported ethnicity, and only a minority reported education level (113/1252, 9.0%), SES (120/1340, 9.0%), and rurality (45/1269, 3.9%). There was no improvement in reporting of each characteristic over the 10-year period. Subject area, funding source, whether a trial was health equity-related, use of a medical writer, and trial setting (high vs. low/middle-income country) were significantly associated with the reporting of ethnicity, education level, and SES.
Conclusions: Reporting of sociodemographic characteristics in infectious diseases RCTs is inconsistent and has not improved over time.
期刊介绍：
Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.
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