Clinical impact of pretreatment human immunodeficiency virus drug resistance in people initiating nonnucleoside reverse transcriptase inhibitor-containing antiretroviral therapy: A systematic review and meta-analysis

Background: Increased access to antiretroviral therapy (ART) has resulted in rising levels of pretreatment human immunodeficiency virus drug resistance (PDR). This is the first systematic review and meta-analysis to assess the impact of PDR on treatment outcomes among people initiating nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART, including the combination of efavirenz (EFV), tenofovir (TDF), and lamivudine or emtricitabine (XTC). Methods: We systematically reviewed studies and conference proceedings comparing treatment outcomes in populations initiating NNRTI-based ART with and without PDR. We conducted subgroup analyses by regimen: (1) NNRTIs + 2 nucleoside reverse transcriptase inhibitors (NRTIs), (2) EFV + 2 NRTIs, or (3) EFV/TDF/XTC; by population (children vs adults); and by definition of resistance (PDR vs NNRTI PDR). Results: Among 6197 studies screened, 32 were analyzed (31 441 patients). We found that individuals with PDR initiating NNRTIs across all the subgroups had increased risk of virological failure compared to those without PDR. Risk of acquisition of new resistance mutations and ART switch was also higher in people with PDR. Conclusions: This review shows poorer treatment outcomes in the presence of PDR, supporting the World Health Organization's recommendation to avoid using NNRTIs in countries where levels of PDR are high

Clinical impact of pretreatment human immunodeficiency virus drug resistance in people initiating nonnucleoside reverse transcriptase inhibitor-containing antiretroviral therapy: a systematic review and meta-analysis

Background: Increased access to antiretroviral therapy (ART) has resulted in rising levels of pretreatment human immunodeficiency virus drug resistance (PDR). This is the first systematic review and meta-analysis to assess the impact of PDR on treatment outcomes among people initiating nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART, including the combination of efavirenz (EFV), tenofovir (TDF), and lamivudine or emtricitabine (XTC). Methods: We systematically reviewed studies and conference proceedings comparing treatment outcomes in populations initiating NNRTI-based ART with and without PDR. We conducted subgroup analyses by regimen: (1) NNRTIs + 2 nucleoside reverse transcriptase inhibitors (NRTIs), (2) EFV + 2 NRTIs, or (3) EFV/TDF/XTC; by population (children vs adults); and by definition of resistance (PDR vs NNRTI PDR). Results: Among 6197 studies screened, 32 were analyzed (31 441 patients). We found that individuals with PDR initiating NNRTIs across all the subgroups had increased risk of virological failure compared to those without PDR. Risk of acquisition of new resistance mutations and ART switch was also higher in people with PDR. Conclusions: This review shows poorer treatment outcomes in the presence of PDR, supporting the World Health Organization's recommendation to avoid using NNRTIs in countries where levels of PDR are high

Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study

Abstract Background Pilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials. Methods We conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design). Results Our search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms “pilot” or “feasibility” in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods. Conclusions Pilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved

Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey

Abstract Background The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials. Objective This methodological survey evaluates the completeness of reporting in pilot randomized controlled trials in chronic kidney disease patients on hemodialysis (HD patients) and explores factors associated with better completion of reporting. Methods The authors searched Pubmed on July 1, 2018, for all pilot trials conducted in HD patients. Reporting quality was assessed against the 40-item Consolidated Standards of Reporting Trials (CONSORT) Extension for Pilot Trials. Study factors including year and country of publication, intervention, number of centers, type of funding, and journal endorsement of CONSORT were also examined. Results The mean number of items reported from the CONSORT extension for pilot trials across all included articles was 18.4 (standard deviation [SD] = 4.4). In the adjusted analysis, studies reported in later years (IRR = 1.026, 95% CI [1.018, 1.034], p < 0.001) and an increase of 20 persons in sample size (adjusted IRR = 1.021, 95% CI [1.010, 1.031], p < 0.001) were associated with a significantly higher number of CONSORT pilot items reported. Conclusions Current reporting completeness of pilot trials in HD patients is suboptimal. Endorsing the CONSORT extension specific to pilot and feasibility studies and ensuring that pilot trials focus on the feasibility objectives may improve reporting completeness of these trials

A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research

Abstract Background Prospective study protocols and registrations can play a significant role in reducing incomplete or selective reporting of primary biomedical research, because they are pre-specified blueprints which are available for the evaluation of, and comparison with, full reports. However, inconsistencies between protocols or registrations and full reports have been frequently documented. In this systematic review, which forms part of our series on the state of reporting of primary biomedical, we aimed to survey the existing evidence of inconsistencies between protocols or registrations (i.e., what was planned to be done and/or what was actually done) and full reports (i.e., what was reported in the literature); this was based on findings from systematic reviews and surveys in the literature. Methods Electronic databases, including CINAHL, MEDLINE, Web of Science, and EMBASE, were searched to identify eligible surveys and systematic reviews. Our primary outcome was the level of inconsistency (expressed as a percentage, with higher percentages indicating greater inconsistency) between protocols or registration and full reports. We summarized the findings from the included systematic reviews and surveys qualitatively. Results There were 37 studies (33 surveys and 4 systematic reviews) included in our analyses. Most studies (n = 36) compared protocols or registrations with full reports in clinical trials, while a single survey focused on primary studies of clinical trials and observational research. High inconsistency levels were found in outcome reporting (ranging from 14% to 100%), subgroup reporting (from 12% to 100%), statistical analyses (from 9% to 47%), and other measure comparisons. Some factors, such as outcomes with significant results, sponsorship, type of outcome and disease speciality were reported to be significantly related to inconsistent reporting. Conclusions We found that inconsistent reporting between protocols or registrations and full reports of primary biomedical research is frequent, prevalent and suboptimal. We also identified methodological issues such as the need for consensus on measuring inconsistency across sources for trial reports, and more studies evaluating transparency and reproducibility in reporting all aspects of study design and analysis. A joint effort involving authors, journals, sponsors, regulators and research ethics committees is required to solve this problem

A scoping review of comparisons between abstracts and full reports in primary biomedical research

Abstract Background Evidence shows that research abstracts are commonly inconsistent with their corresponding full reports, and may mislead readers. In this scoping review, which is part of our series on the state of reporting of primary biomedical research, we summarized the evidence from systematic reviews and surveys, to investigate the current state of inconsistent abstract reporting, and to evaluate factors associated with improved reporting by comparing abstracts and their full reports. Methods We searched EMBASE, Web of Science, MEDLINE, and CINAHL from January 1st 1996 to September 30th 2016 to retrieve eligible systematic reviews and surveys. Our primary outcome was the level of inconsistency between abstracts and corresponding full reports, which was expressed as a percentage (with a lower percentage indicating better reporting) or categorized rating (such as major/minor difference, high/medium/low inconsistency), as reported by the authors. We used medians and interquartile ranges to describe the level of inconsistency across studies. No quantitative syntheses were conducted. Data from the included systematic reviews or surveys was summarized qualitatively. Results Seventeen studies that addressed this topic were included. The level of inconsistency was reported to have a median of 39% (interquartile range: 14% - 54%), and to range from 4% to 78%. In some studies that separated major from minor inconsistency, the level of major inconsistency ranged from 5% to 45% (median: 19%, interquartile range: 7% - 31%), which included discrepancies in specifying the study design or sample size, designating a primary outcome measure, presenting main results, and drawing a conclusion. A longer time interval between conference abstracts and the publication of full reports was found to be the only factor which was marginally or significantly associated with increased likelihood of reporting inconsistencies. Conclusions This scoping review revealed that abstracts are frequently inconsistent with full reports, and efforts are needed to improve the consistency of abstract reporting in the primary biomedical community

Supplemental Material, Supplementary_Material - A Systematic Survey of Control Groups in Behavioral and Social Science Trials

<p>Supplemental Material, Supplementary_Material for A Systematic Survey of Control Groups in Behavioral and Social Science Trials by Mei Wang, Guangwen Sun, Yaping Chang, Yanling Jin, Alvin Leenus, Muhammad Maaz, Guowei Li, Meha Bhatt, Luciana P. F. Abbade, Ikunna Nwosu, Laura Zielinski, Nitika Sanger, Bianca Bantoto, Candice Luo, Ieta Shams, Hamnah Shahid, Jonathan Adachi, Lawrence Mbuagbaw, Mitchell Levine, Zainab Samaan, and Lehana Thabane in Research on Social Work Practice</p