Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada.
BMC Med Res Methodol. 2021 Apr 19;21(1):76. doi: 10.1186/s12874-021-01258-1.
The expansion of access to antiretroviral therapy (ART) has been accompanied by an increase in pre-treatment drug resistance (PDR). While it is critical to monitor the increasing prevalence of PDR across countries and populations to inform optimal regimen selection, the completeness of reporting is often suboptimal, limiting the interpretation and generalizability of the results. Indeed, there is no formal guidance on how studies investigating the prevalence of drug resistance should be reported. Thus, we sought to determine the completeness of reporting in studies of PDR and the factors associated with sub-optimal reporting to ascertain the need for guidelines.
As part of a systematic review on the global prevalence of PDR in key populations (men who have sex with men, sex workers, transgender people, people who inject drugs and people in prisons), we searched 10 electronic databases until January 2019. We extracted information on selected study characteristics useful for interpreting prevalence data. Data were extracted in duplicate. Analyses of variance and correlation were used to explore factors that may explain the number of items reported.
We found 650 studies of which 387 were screened as full text and 234 were deemed eligible. The included studies were published between 1997 and 2019 and included a median of 239 (quartile 1 = 101; quartile 3 = 778) participants. Most studies originated from high-income countries (125/234; 53.0%). Of 23 relevant data items, including study design, setting, participant sociodemographic characteristics, HIV risk factors, type of resistance test conducted, definition of resistance, the mean (standard deviation) number of items reported was 13 (2.2). We found that more items were reported in studies published more recently (r = 0.20; p < 0.002) and in studies at low risk of bias (F [2231] = 8.142; p < 0.001).
Incomplete reporting in studies on PDR makes characterising levels of PDR in subpopulations across countries challenging. Hence, guidelines are needed to define a minimum set of variables to be included in such studies.
抗逆转录病毒疗法（ART）的可及性扩大伴随着治疗前耐药性（PDR）的增加。虽然监测各国和各人群中 PDR 的流行率以确定最佳方案选择至关重要，但报告的完整性往往不够理想，限制了结果的解释和推广。事实上，目前尚无关于如何报告研究耐药性流行率的正式指南。因此，我们旨在确定 PDR 研究报告的完整性以及与报告不完整相关的因素，以确定是否需要制定指南。
作为全球关键人群（男男性行为者、性工作者、跨性别者、注射毒品者和监狱人群）中 PDR 流行率的系统综述的一部分，我们检索了 10 个电子数据库，检索时间截至 2019 年 1 月。我们提取了有助于解释流行率数据的选定研究特征信息。数据由两人重复提取。方差分析和相关性分析用于探讨可能解释报告项目数量的因素。
我们发现了 650 项研究，其中 387 项进行了全文筛选，234 项被认为符合条件。纳入的研究发表于 1997 年至 2019 年之间，中位数纳入 239 名（四分位距 1 = 101；四分位距 3 = 778）参与者。大多数研究来自高收入国家（125/234；53.0%）。在 23 个相关数据项目中，包括研究设计、地点、参与者的社会人口学特征、艾滋病毒风险因素、进行的耐药性测试类型、耐药性定义，报告的平均（标准差）项目数量为 13（2.2）。我们发现，发表时间较近的研究（r = 0.20；p < 0.002）和低偏倚风险的研究（F [2231] = 8.142；p < 0.001）报告的项目更多。
PDR 研究报告的不完整使得难以描述各国亚人群中 PDR 的水平。因此，需要制定指南，确定此类研究中应包含的最小变量集。
