Developing Reporting Guidelines for Studies of HIV Drug Resistance Prevalence: Protocol of a Mixed-methods Study (Preprint)

BACKGROUND HIV drug resistance is a global health problem which limits the effectiveness of antiretroviral therapy (ART). 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. OBJECTIVE This paper aims to develop reporting guidelines for studies of HIV drug resistance by achieving consensus among experts on what items should be reported in these studies. METHODS 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, which will be analyzed in a validity ratio to determine the items that will be retained for further evaluation. Retained items will form a list of potential reporting items that will be reviewed in a focus group discussion informed by grounded theory to produce a finalized set of reporting items. RESULTS This study received ethics approval from the Hamilton Integrated Research Ethics Board (project number #11558) on November 11, 2020. As of March 2021, 46 participants provided informed consent and completed the electronic survey. In October 2021 nine of these participants participated in virtual focus group discussions. CONCLUSIONS This study will provide a reporting checklist for studies of HIV drug resistance by achieving consensus 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.

Designing and Using Surveys in Nursing Research: A Contemporary Discussion

This commentary summarizes the contemporary design and use of surveys or questionnaires in nursing science, particularly in light of recent reporting guidelines to standardize and improve the quality of survey studies in healthcare research. The benefits, risks, and limitations of these types of data collection tools are also briefly discussed.

Early Termination of Acute Stroke Randomized Controlled Trials Published Between 2013 and 2020: A Systematic Review

Background: Termination of a clinical trial before the maximum planned sample size is accrued can occur for multiple valid reasons but has implications for the interpretation of results. We undertook a systematic review of contemporary acute stroke trials to document the prevalence of and reasons for early termination. Methods: We searched MEDLINE for randomized controlled trials of acute stroke therapies published between 2013 and 2020 in 9 major clinical journals. Manuscripts describing the primary results of phase 2 and phase 3 trials of acute stroke care were included. Data on study characteristics and adherence to CONSORT reporting guidelines were abstracted and summarized using descriptive statistics. Where feasible, we compared treatment effect sizes between trials terminated early and those not terminated early. Results: Of 96 randomized controlled trials, 39 (41%) were terminated early, 84 (88%) had a data and safety monitoring board, and 57 (59%) reported a prespecified statistical stopping rule. Among the 39 trials terminated early, 10 were discontinued for benefit, 10 due to logistical issues, 8 for futility, 6 because of newly available evidence, 1 for harm, and 4 for other or a combination of reasons. The median percentage of the maximum planned sample size accrued among trials terminated early was 63% (range, 8%–89%). Only 55% of trials (53 of 96) reported whether interim efficacy analyses were conducted, as recommended by the CONSORT guidelines. When 10 endovascular therapy trials were compared according to early termination status, the effect sizes of trials terminated early for benefit were only modestly larger than those not terminated early. Conclusions: The high prevalence of early termination in combination with the wide variety of reasons underscores the necessity of meticulous trial planning and adherence to methodological and reporting guidelines for early termination. Registration: URL: https://www.crd.york.ac.uk/prospero/ ; Unique identifier: CRD42019128727.

Sex and gender considerations in reporting guidelines for health research: a systematic review

Background Despite growing recognition of the importance of sex and gender considerations in health research, they are rarely integrated into research design and reporting. We sought to assess the integration of sex, as a biological attribute, and gender, as a socially constructed identity, in published reporting guidelines. Methods We conducted a systematic review of published reporting guidelines listed on the EQUATOR website (www.equator-nework.org) from inception until December 2018. We selected all reporting guidelines (original and extensions) listed in the EQUATOR library. We used EndNote Citation Software to build a database of the statements of each guideline identified as a "full bibliographic reference" and retrieved the full texts. Reviewers independently extracted the data on use of sex and gender terms from the checklist/abstract/main text of guidelines. Data were analyzed using descriptive statistics and narrative synthesis. Results A total of 407 reporting guidelines were included; they were published between 1995 and 2018. Of the 407 guidelines, 235 (57.7%) mentioned at least one of the sex- and gender-related words. In the checklist of the reporting guidelines (n = 363), “sex” and “gender” were mentioned in 50 (13.8%) and 40 (11%), respectively. Only one reporting guideline met our criteria (nonbinary, appropriate categorization, and non-interchangeability) for correct use of sex and gender concepts. Trends in the use of "sex" and "gender" in the checklists showed that the use of “sex” only started in 2003, while “gender” has been in use since 1996. Conclusions We assessed the integration of sex and gender in reporting guidelines based on the use of sex- and gender-related words. Our findings showed a low use and integration of sex and gender concepts and their incorrect use. Authors of reporting guidelines should reduce this gap for a better use of research knowledge. Trial registration PROSPERO no. CRD42019136491.