Cochrane South Africa, South African Medical Research Council, Tygerberg, Cape Town, South Africa.
Communicable Disease Control, Department of Health, Western Cape, Cape Town, South Africa.
PLoS One. 2021 Mar 19;16(3):e0248621. doi: 10.1371/journal.pone.0248621. eCollection 2021.
Mycobacterium Tuberculosis (TB) poses a substantial burden in sub-Saharan Africa and is the leading cause of death amongst infectious diseases. Randomised controlled trials (RCTs) are regarded as the gold standard for evaluating the effectiveness of interventions. We aimed to describe published TB treatment trials conducted in Africa.
This is a cross-sectional study of published TB trials conducted in at least one African country. In November 2019, we searched three databases using the validated Africa search filter and Cochrane's sensitive trial string. Published RCTs conducted in at least one African country were included for analysis. Records were screened for eligibility. Co-reviewers assisted with duplicate data extraction. Extracted data included: the country where studies were conducted, publication dates, ethics statement, trial registration number, participant's age range. We used Cochrane's Risk of Bias criteria to assess methodological quality.
We identified 10,495 records; 175 trials were eligible for inclusion. RCTs were published between 1952 and 2019. The median sample size was 206 participants (interquartile range: 73-657). Most trials were conducted in South Africa (n = 83) and were drug therapy trials (n = 130). First authors were from 30 countries globally. South Africa had the most first authors (n = 55); followed by the United States of America (USA) (n = 28) and Great Britain (n = 14) with fewer other African countries contributing to the first author tally. Children under 13 years of age eligible to participate in the trials made up 17/175 trials (9.71%). International governments (n = 29) were the most prevalent funders. Ninety-four trials provided CONSORT flow diagrams. Methodological quality such as allocation concealment and blinding were poorly reported or unclear in most trials.
By mapping African TB trials, we were able to identify potential research gaps. Many of the global north's researchers were found to be the lead authors in these African trials. Few trials tested behavioural interventions compared to drugs, and far fewer tested interventions on children compared to adults to improve TB outcomes. Lastly, funders and researchers should ensure better methodological quality reporting of trials.
结核分枝杆菌（TB）在撒哈拉以南非洲造成了巨大负担，是传染病死亡的主要原因。随机对照试验（RCT）被认为是评估干预措施有效性的金标准。我们旨在描述在非洲进行的已发表的结核病治疗试验。
这是一项在至少一个非洲国家进行的已发表结核病试验的横断面研究。2019 年 11 月，我们使用经过验证的非洲搜索筛选器和 Cochrane 的敏感试验字符串在三个数据库中进行了搜索。纳入了在至少一个非洲国家进行的已发表的 RCT 进行分析。记录被筛选出符合条件的记录。共同审查员协助进行重复数据提取。提取的数据包括：研究开展的国家、出版日期、伦理声明、试验登记号、参与者的年龄范围。我们使用 Cochrane 的偏倚风险标准来评估方法学质量。
我们确定了 10495 条记录；175 项试验符合纳入标准。RCT 发表于 1952 年至 2019 年之间。中位样本量为 206 名参与者（四分位距：73-657）。大多数试验在南非（n=83）进行，且为药物治疗试验（n=130）。第一作者来自全球 30 个国家。南非拥有最多的第一作者（n=55）；其次是美利坚合众国（n=28）和英国（n=14），其他非洲国家的第一作者人数较少。符合条件的 13 岁以下儿童占 17/175 项试验（9.71%）。国际政府（n=29）是最常见的资助者。94 项试验提供了 CONSORT 流程图。在大多数试验中，分配隐藏和盲法等方法学质量的报告很差或不清楚。
通过绘制非洲结核病试验图，我们能够发现潜在的研究差距。在这些非洲试验中，许多来自全球北方的研究人员是主要作者。与药物相比，行为干预试验较少，与成人相比，针对儿童的干预试验以改善结核病结果的试验更少。最后，资助者和研究人员应确保更好地报告试验的方法学质量。
