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HIV drug resistance is a global health problem that limits the effectiveness of antiretroviral therapy. Adequate surveillance of HIV drug resistance is challenged by heterogenous and inadequate data reporting, which compromises the accuracy, interpretation, and usability of prevalence estimates. Previous research has found that the quality of reporting in studies of HIV drug resistance prevalence is low, and thus better guidance is needed to ensure complete and uniform reporting.
This paper contributes to the process of developing reporting guidelines for prevalence studies of HIV drug resistance by reporting the methodology used in creating a reporting item checklist and generating key insights on items that are important to report.
We will conduct a sequential explanatory mixed methods study among authors and users of studies of HIV drug resistance. The two-phase design will include a cross-sectional electronic survey (quantitative phase) followed by a focus group discussion (qualitative phase). Survey participants will rate the essentiality of various reporting items. This data will be analyzed using content validity ratios to determine the items that will be retained for focus group discussions. Participants in these discussions will revise the items and any additionally suggested items and settle on a complete reporting item checklist. We will also conduct a thematic analysis of the group discussions to identify emergent themes regarding the agreement process.
As of November 2021, data collection for both phases of the study is complete. In July 2021, 51 participants had provided informed consent and completed the electronic survey. In October 2021, focus group discussions were held. Nine participants in total participated in two virtual focus group discussions. As of May 2022, data are being analyzed.
This study supports the development of a reporting checklist for studies of HIV drug resistance by achieving agreement among experts on what items should be reported in these studies. The results of this work will be refined and elaborated on by a writing committee of HIV drug resistance experts and external reviewers to develop finalized reporting guidelines.
DERR1-10.2196/35969
An estimated 38 million people were living with HIV worldwide in 2019 [
Drug resistance to antiretroviral therapy may be acquired when there is viral replication in the presence of a drug [
HIV drug resistance is a recognized global health problem [
The prevalence of drug resistance varies among people living with HIV, but is higher in certain high-risk populations such as men who have sex with men, sex workers, transgender people, people who inject drugs, people in prisons, pregnant women, and adolescents and children; resistance prevalence also varies by sex, ethnicity, and HIV subtype due to differences antiretroviral exposures [
Adequate monitoring of HIV drug resistance across countries and populations is often challenged by heterogenous and inadequate data reporting. In our previous systematic review of pretreatment drug resistance in key populations, we found that the quality of reporting in studies of HIV drug resistance prevalence is low [
In 2010, Moher et al [
The objective of this study is to develop a reporting item checklist for prevalence studies of HIV drug resistance by achieving agreement among experts on items that should be reported in studies of HIV drug resistance prevalence. This mixed methods study includes (1) a quantitative phase with survey methodology to identify a list of reporting items considered by participants to be essential, (2) focus group methods to identify emergent themes on reporting items that are essential to HIV drug resistance prevalence studies, and (3) data integration methods to explain discrepancies between quantitative and qualitative data as well as the rationale behind what makes a reporting item important to HIV drug resistance research.
We will conduct a sequential explanatory mixed methods study (QUAN → qual) among authors of studies of HIV drug resistance. This design comprises two phases: a cross-sectional electronic survey (quantitative phase) and subsequent focus group discussions (qualitative phase). The results of the survey will be used to develop an initial list of potential reporting items and additionally suggested reporting items, which will be evaluated, revised, and expanded upon in the qualitative phase. Transcripts from the focus group discussions will provide key agreement-based insights on why these items are important to report.
Mixed methods suit research objectives that cannot met by either qualitative or quantitative methodologies alone [
The quantitative phase will include a convenience purposeful sample of corresponding authors of studies of HIV drug resistance. In our 2020 systematic review [
All survey participants will be asked to indicate if they are interested in the focus group discussions. In the qualitative phase, we intend to include a sample of 20 survey respondents who agreed to participate in the focus group discussion (2 groups of 10 participants). We will select these participants with considerations of sex and geographical diversity, such that we have at least one male and one female participant from as many of the 6 WHO regions as possible: African Region, Region of the Americas, South-East Asia Region, European Region, Eastern Mediterranean Region, and Western Pacific Region [
Authors of drug resistance prevalence studies will be invited to take an electronic survey on the Research Electronic Data Capture (REDCap) tool hosted at St. Joseph’s Healthcare Hamilton and open from November 2020 to June 2021. REDCap is a secure, web-based application designed for data capture in research [
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 [
Selected individuals who expressed interest in participating in the survey and who consent to being contacted will be approached to set up a convenient time for a group discussion in October 2021. Participants will be given the opportunity to provide consent prior to discussions and for the discussions to be recorded. Interviews will be conducted over Zoom (a videoconferencing platform with real-time messaging and content sharing). The discussions will be moderated by a chair who will ensure that participants are able to contribute freely and openly. The moderator will introduce the session and initiate the discussions based on a focus group discussion guide (see
Baseline data and outcomes will be summarized as counts (percentage) for categorical variables, and mean (standard deviation) or median (first quartile, third quartile) for continuous or discrete variables as appropriate depending on the distribution. The ordinal data from potential reporting items will be used to compute a validity ratio. The coding of the essentiality ordinal scale is as follows: essential (3), useful but not essential (2), and not necessary (1). Data on the inclusion of additional reporting items from the open-text fields will be summarized and discussed in the qualitative phase.
A validity ratio will be computed as
The discussions will be transcribed from recordings and coded into categories by two independent coders and compared for consistency. During the discussions, participants will go over the selected set of reported items and confirm their choice of whether they are essential reporting items. They will also examine the grammar and wording of the items. Participants may propose new items (except items dropped from the survey in the quantitative phase) and these will be discussed. These discussions will be used to finalize the selection of items for the finalized reporting guideline. Qualitative data analysis will be informed by grounded theory, where open codes are generated by identifying repetitions in the text [
Outline of mixed methods study.
In the quantitative phase, we will pilot test our survey. In the qualitative phase, we will use member-checking, audio-video recordings, and duplicate coding to validate our data. During the focus group discussions, moderator bias will be minimized by using a discussion guide.
Consensus will be determined statistically in the quantitative phase using item-specific validity ratios so that the items that at least 50% of participants rated essential are kept in the initial reporting item checklist at the end of the quantitative phase. In the qualitative phase, focus groups will seek agreement on both the reporting item checklist and additionally suggested items generated in the quantitative phase. Agreement is inferred when at least one participant verbally speaks on whether a reporting item was essential or not and there are no verbal objections with the statement. Therefore, agreement also involves the failure to speak up against specific items.
This study received ethics approval from the Hamilton Integrated Research Ethics Board (project number #11558) on November 11, 2020, and received annual renewal approval on September 27, 2021. Only participants who provide informed consent will participate in the study. Participants will be able to stop the electronic survey or withdraw from the focus group discussions at any time.
The electronic survey was open from November 2020 to June 2021. In total, 51 participants provided informed consent and completed the electronic survey. Once the quantitative phase data collection and analysis was complete, virtual focus group discussions were held in October 2021. We conducted two focus group sessions of 9 participants in total. As of May 2022, results of both the electronic survey and focus group discussions are being analyzed. A flowchart of items dropped and retained in the checklist is provided in
Flow diagram of reporting items dropped and kept in checklist.
In this study, we will use mixed methods to produce a reporting item checklist of items to be considered in the process of developing reporting guidelines for studies of HIV drug resistance prevalence. We will explore and highlight the insights gained from using mixed methods to meet our study objectives. An explanatory sequential design was selected for this study to allow for the use of qualitative data to explain results from the quantitative findings, and breadth and depth in the data collected [
We anticipate that most of the initially proposed reporting items presented in the survey will be rated as essential and go on to be evaluated in the focus group discussions. We also expect additional reporting items will be suggested by survey participants, which will also be evaluated in the focus group discussions. During the focus group discussions, we expect considerable agreement on the inclusion of most reporting items proposed in the quantitative phase, with disagreements on areas of wording, grammar, and relevance to specific types of HIV drug resistance research designs. As the purpose of this study is to develop a reporting item checklist and key insights to inform the development of reporting guidelines, we anticipate participants will discuss important considerations that the complete reporting guidelines must consider to be accessible and relevant to all authors and users of HIV drug resistance prevalence research, including any concerns over data privacy and confidentiality.
The strengths of this study include the integration of both quantitative and qualitative methodologies to elicit consensus and agreement from experts on the items that should be reported in studies of HIV drug resistance. Additionally, validation checks will be made in both phases of the study to improve data quality. Study limitations include the susceptibility to low response rates in the quantitative phase and therefore the potential for response bias. We have estimated a sample size to determine the minimum number of responses required for the quantitative phase. However, we have specifically incorporated approaches to enhancing diversity of views by reviewing the geographic coverage of the quantitative data, and purposefully selecting participants from high- and low-income settings for the focus group discussions and as external reviewers.
The results of this work will be presented as peer-reviewed manuscripts, conference presentations, and as part of a master’s thesis. Participants who express interest in the findings of the study will also be sent the results of this work.
We will incorporate several knowledge translation strategies including engagement of opinion leaders in the agreement discussions (eg, study authors), and through linkage and exchange mechanisms (ie, connecting researchers and knowledge users to facilitate dissemination, for example via educational workshops and project summary briefings to stakeholders) [
During focus group discussions, we will ask participants about any perceptions of barriers for practice change (eg, at the level of HIV drug resistance prevalence study design) and uptake of the reporting guideline. We will use this feedback to tailor educational activities (eg, conference presentations) and dissemination efforts (eg, preferences for receiving the information) for this audience. For example, to increase awareness about reporting issues and the reporting guideline, we will present findings about the impacts of missing study data, as well as ensure that we target local, national, and international conferences for dissemination activities. We will publish manuscripts arising from this work in open-access journals.
Knowledge translation impact and evaluation will be measured at the level of the HIV research community using the following metrics: reach and use indicators (eg, number of times manuscripts are accessed and cited), collaboration indicators (eg, endorsement by relevant journals in the field), and practice change indicators (eg, improvements in reporting over time) [
The checklist of items and agreement-based insights produced by this study will be refined, elaborated, and considered by a writing committee of experts in HIV drug resistance. We will also invite external reviewers from international organizations such as the WHO, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Elizabeth Taylor Foundation, and the Centers for Disease Control and Prevention (CDC) to provide feedback on the reporting guidelines.
We seek to develop a reporting item checklist for studies of HIV drug resistance prevalence and a better understanding of what makes a reporting item important to HIV drug resistance prevalence research. The forthcoming reporting item checklist will directly inform the explanation and elaboration document that will have detailed justifications and rationale for each reporting item in the checklist.
Electronic survey distributed as part of the quantitative phase.
Qualitative interview guide used during focus group discussions.
Centers for Disease Control and Prevention
ChEcklist for studies of Drug ResIstanCe in HIV
Enhancing the Quality and Transparency of Health Research
Research Electronic Data Capture
Joint United Nations Programme on HIV/AIDS
World Health Organization
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
None declared.