Article type
Year
Abstract
Introduction: Few studies have evaluated the characteristics of RCTs conducted in LAC countries.Methods: A review of RCTs published in 2010 in which the author’s affiliation was from LAC was performed in PUBMED-LILACS; the RCT was included if it explicitly used the word 'random’ or variations thereof. Two reviewers independently extracted key data and assessed the risk of bias (RoB).
Results: We identified 1695 references including 526 RCTs (N = 73.513) recruiting 139.8 (SD = 284.53) participants on average. English was the dominant publication language (93%); with Spanish (3.4%) and Portuguese (2.9%) following. We found RCTs with affiliations representing 19 LAC countries; 70% were from Brazil. Maternal health represented 6.7% and neglected diseases-HIV-tuberculosis-malaria 3.8%. We assessed the following characteristics in a sample of 326/526 RCTs. Settings/Authorship: 7.7% were multinational and 12.0% multicenter. 10.6% included a co-author from a different country (the USA being the most frequent). Participant’s sex: 75.3% of RCTs recruited men and women; 19.6% exclusively women. Overall, 57.4% of participants were women. Gender analysis was performed in 6.8% of studies. 19% were < 18 years.
Type of intervention: Drugs (47.3%) and procedures (24.5%) were the most frequent.
Follow-up: Short term (<1month) (38%) and 1-6 months 39% were the most frequent.
Risk of bias: Scores were low (25.2%), unclear (60.1%), and high (14.7%). Ethic/Conflict of interest: 95.1% reported approval by ethics review committee and 93.1% presented an informed consent process. Conflicts of interest were declared by at least one author in 11.5% of RCTs; 42.5% failed to provide a declaration.
Funding: Public 33.9% private (i.e. pharmaceutical) 14.4% not reported 36.6% others (i.e. mixed-NGO) 15.1%. More frequent funders were FAPESP, CAPES and CNPq from Brazil.
Conclusion: There is plenty of room for improvement in South-South collaboration and RCTs addressing regional priorities. Methods and result reporting of RCTs should be improved to meet international standards.
Results: We identified 1695 references including 526 RCTs (N = 73.513) recruiting 139.8 (SD = 284.53) participants on average. English was the dominant publication language (93%); with Spanish (3.4%) and Portuguese (2.9%) following. We found RCTs with affiliations representing 19 LAC countries; 70% were from Brazil. Maternal health represented 6.7% and neglected diseases-HIV-tuberculosis-malaria 3.8%. We assessed the following characteristics in a sample of 326/526 RCTs. Settings/Authorship: 7.7% were multinational and 12.0% multicenter. 10.6% included a co-author from a different country (the USA being the most frequent). Participant’s sex: 75.3% of RCTs recruited men and women; 19.6% exclusively women. Overall, 57.4% of participants were women. Gender analysis was performed in 6.8% of studies. 19% were < 18 years.
Type of intervention: Drugs (47.3%) and procedures (24.5%) were the most frequent.
Follow-up: Short term (<1month) (38%) and 1-6 months 39% were the most frequent.
Risk of bias: Scores were low (25.2%), unclear (60.1%), and high (14.7%). Ethic/Conflict of interest: 95.1% reported approval by ethics review committee and 93.1% presented an informed consent process. Conflicts of interest were declared by at least one author in 11.5% of RCTs; 42.5% failed to provide a declaration.
Funding: Public 33.9% private (i.e. pharmaceutical) 14.4% not reported 36.6% others (i.e. mixed-NGO) 15.1%. More frequent funders were FAPESP, CAPES and CNPq from Brazil.
Conclusion: There is plenty of room for improvement in South-South collaboration and RCTs addressing regional priorities. Methods and result reporting of RCTs should be improved to meet international standards.