Guidelines are needed for studies of pre-treatment HIV drug resistance: a methodological study

Abstract

Background 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. Methods 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. Results 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). Conclusions 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.

Developing Reporting Guidelines for Studies of HIV Drug Resistance Prevalence: Protocol for a Mixed Methods Study

“…The survey includes 23 three-scale ordinal questions, one for each potential reporting item. These 23 items were selected in our previous methodological assessment of reporting completeness of HIV drug resistance prevalence research [ 17 ]. This list is not exhaustive, and participants are invited to add more items.…”

“…This compromises the accuracy, interpretation, and usability of prevalence estimates, especially if key data are not reported, including precision of the estimates, representativeness and diversity of the participants included, techniques used to measure resistance, participants’ transmission risk group, prior exposure to treatments, and class of drug for which resistance was tested [ 15 ]. Our recent methodological study concluded that while reporting has improved over time [ 8 ], guidance is needed to ensure complete and uniform reporting to improve the interpretation of study findings, generalizability, and comparability of prevalence estimates, while accounting for differences in geographical settings and populations [ 17 ].…”

“…In 2010, Moher et al [ 18 ] published guidance for researchers seeking to develop health research reporting guidelines, outlining a strategy emphasizing the importance of using robust and widely accepted methodologies. In accordance with this strategy and to initiate the process of developing reporting guidelines for studies of HIV drug resistance prevalence, our prior work evaluated the completeness of reporting of HIV drug resistance prevalence literature, the results of which supported the need for reporting guidelines [ 15 , 17 ]. We have registered this guideline project on the EQUATOR (Enhancing the Quality and Transparency of Health Research) network as CEDRIC-HIV (ChEcklist for studies of Drug ResIstanCe in HIV) [ 19 ].…”

Developing a reporting item checklist for studies of HIV drug resistance prevalence or incidence: a mixed methods study

“…2 However, adequate monitoring of HIV drug resistance worldwide is compromised by heterogenous and inadequate data reporting. 3 …”

Towards Next-Generation Sequencing for HIV-1 Drug Resistance Testing in a Clinical Setting

“…Despite the absence of a complete cure for the disease, research has made great advances in providing treatment regimens to mitigate the transmission of the virus. The development of antiretroviral therapies (ART), such as the highly active antiretroviral therapy (HAART), has proved to be effective in the suppression of HIV replication [ 2 ], and numerous studies have shown that the use of HIV drug resistance tests to guide therapy is associated with improved treatment outcomes [ 3 , 4 , 5 , 6 ]. The global scale-up of HAART has also dramatically decreased the rates of AIDS-related mortality and morbidity [ 7 ].…”