Gaelen P Adam

Comparative Effectiveness of Management Strategies for Renal Artery Stenosis: An Updated Systematic Review

As the population continues to age, the prevalence of atherosclerotic renal artery stenosis (ARAS) is increasing. Prevalence is particularly high among persons with risk factors for cardiovascular disease (CVD), with estimates ranging from 10.5% among patients undergoing coronary angiography to 54% among those with congestive heart failure (1). Among persons aged 66 years or older, 6.8% have been found to have ARAS (2). Hemodynamically significant ARAS, defined as at least 50% to 70% stenosis, is a leading cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD) (3, 4). Options for ARAS treatment are medical therapyincluding aggressive blood pressure (BP) control, statins, and antiplateletsor renal artery revascularization with continued medical therapy. Percutaneous transluminal renal angioplasty with stent placement (PTRAS) is the current standard for revascularization (5). Use of PTRAS has decreased from its peak in 2006 but remains common at 6.7 procedures per 100000 adults (6). A 2007 systematic review of management strategies for ARAS concluded that the evidence did not support one treatment approach over another, and no defined set of clinical or intervention characteristics was convincingly associated with CVD, BP control, and kidney function (7, 8). Since then, 2 large trialsCORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) (9) and ASTRAL (Angioplasty and Stenting for Renal Artery Lesions) (10)have been published, each calling into question the clinical value of invasive intervention for ARAS. Given the inconclusive prior review and new evidence, it is timely to reevaluate the comparative benefits and harms of strategies for management of patients with ARAS and to identify factors that may predict which patients are most likely to benefit from each intervention. Methods This review was based on a systematic review commissioned by the Agency for Healthcare Research and Quality (AHRQ). It followed a standard AHRQ protocol with input from a panel of nephrologists, invasive cardiologists, radiologists, and vascular surgeons. The protocol was published at www.effectivehealthcare.ahrq.gov on 20 January 2015. Data Sources We searched MEDLINE and EMBASE from January 2007 through 16 March 2016 and the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews through the fourth quarter of 2015. Eligible studies published between 1993 and 2007 from our previous systematic reviews (7, 8) were also included. We supplemented the search with studies in the U.S. Food and Drug Administration database, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform; recent systematic reviews; and proceedings of national renal, vascular surgery, and urology conferences from 2012 through 2014. We solicited additional citations from our expert panel and from manufacturers. The electronic search strategy combined terms for renal artery stenosis, renal hypertension, and renal vascular disease and was limited to adult humans, relevant research designs, and the English language (Supplement Table 1). Supplement. Supplemental Information Study Selection Six researchers screened citations in duplicate. We included studies of adults treated for ARAS that reported long-term (6 months) outcomes or adverse events. The outcomes of interest were all-cause mortality; kidney function (renal replacement therapy [RRT] and categorical and continuous changes in glomerular filtration rate [GFR], creatinine clearance, or serum creatinine level); BP control (hypertension and categorical and continuous changes in BP); CVD, including congestive heart failure; and adverse events, including medication-related and procedural complications. We included randomized, controlled trials (RCTs) and nonrandomized, comparative studies (NRCSs) comparing PTRAS versus any medical therapy with at least 10 participants per group. Noncomparative (single-group) studies were eligible only if they reported adverse events or outcome predictors and had at least 30 participants (PTRAS studies) or at least 10 participants (medication-only studies). We also included the 20 most recent (through 2014) case reports of patients with acute ARAS decompensation because of a concern that these patients would not have been included in other studies. Studies of open surgical revascularization and other noncomparative studies are reported elsewhere (11). We excluded studies that evaluated ARAS treatment in patients with kidney transplantation, renal cell or other carcinoma, concurrent aortic or aortoiliac aneurysm repair, or prior revascularization and studies in which more than 20% of the study population had non-ARAS disease. Data Extraction and Assessment Data from each study were extracted by 1 of 6 experienced methodologists and confirmed by at least 1 other. Extracted data included study, participant, and ARAS characteristics; interventions; outcomes; and study design. We applied the Cochrane risk-of-bias tool for RCTs (12) and selected questions from the Newcastle-Ottawa Scale (13) about comparability of cohorts, representativeness of the population, and adjustment for different lengths of follow-up. Two reviewers independently assessed risk of bias at the study level, with notation of specific outcomes at increased risk of bias (for example, due to high attrition). Two reviewers independently categorized the strength of evidence across studies as high, moderate, or low for each outcome category on the basis of the number of studies, study designs, study limitations (such as risk of bias), applicability, consistency of study results, precision of effect estimates, likelihood of reporting bias, other limitations, and summary findings across studies (14). Data Synthesis Meta-analysis was not conducted because of significant clinical heterogeneity. Between-group comparisons are summarized by effect size (expressed as either a hazard ratio [HR] or an odds ratio) and were synthesized qualitatively. Role of the Funding Source The funding agency (AHRQ) participated in protocol development and reviewed the full report. The research team independently conducted the review. Results The literature search retrieved 1560 citations, of which 189 were evaluated as full-text articles in addition to 54 studies from the 2006 and 2007 evidence reports and other systematic reviews and 74 case reports (Appendix Figure 1). In total, 83 studies (33 of which were newly identified) were eligible, including 15 that compared PTRAS with medical therapy; 39 that provided data on adverse events; 28 outcome predictor, subgroup, or co-treatment analyses; and 20 case reports of acute decompensation. Appendix Figure 1. Literature flow diagram. ARAS = atherosclerotic renal artery stenosis; NRCS = nonrandomized, comparative study; PTRAS = percutaneous transluminal renal angioplasty with stent placement; RCT = randomized, controlled trial. * Does not include studies that were screened and excluded for the 2006 report. Studies of open surgical revascularization and other noncomparative studies are reported elsewhere (11). Characteristics of Comparative Studies Fifteen comparative studies with 4006 total patients compared PTRAS with medical therapy for ARAS. Of these, 7 were RCTs (9, 10, 1521) and 8 were NRCSs (2229). The 7 RCTs analyzed a total of 2178 patients. The 2 largest RCTs (CORAL [9] and ASTRAL [10]) reported on 931 and 806 patients, respectively, and the remaining RCTs included a range of 52 to 140 patients (9, 10, 1517, 19, 21). Enrolled patients had uncontrolled BP while receiving at least 2 medications and up to about stage 3 or 4 CKD (Table 1; Supplement Table 2). The definitions of ARAS varied across studies (Supplement Table 3). Only the CORAL trial measured stenosis severity with translesional pressure gradients (9). All trials excluded patients with acute decompensation. Three of the 7 RCTs had high risk of attrition bias, and 2 had unclear risk. Two RCTs have been reported only as conference abstracts (19, 21); both had incomplete study descriptions and high risk of selective outcome reporting, and 1 included only selected patients from a terminated trial (21) (Supplement Table 4). Table 1. Characteristics and Main Results of Comparative Studies of PTRAS Versus Medical Therapy Table 1Continued Eight NRCSs compared PTRAS with medical therapy among 1828 patients (2229). All NRCSs included patients who had uncontrolled BP while receiving at least 2 medications and about stage 3 to 4 CKD. Four studies included patients with acute flash pulmonary edema or acute kidney injury (25, 26, 28, 29). The NRCSs were about evenly divided between high and low risk of selection bias (5 with high risk and 3 with low risk), attrition bias (incomplete outcome data; 3 with high risk and 5 with low risk), and selective reporting bias (3 with high risk, 4 with low risk, and 1 with unclear risk). In all NRCSs, the sample representativeness was rated as having low risk of bias. Reporting of medical therapy was often incomplete, and none of the NRCSs adequately adjusted for potential confounders. Effects of Interventions on Outcomes Mortality We found low strength of evidence of no difference in mortality, but none of the studies was powered to detect differences between PTRAS and medical therapy. Four RCTs (9, 10, 15, 16) reported mortality data for 1 to 5 years of follow-up, and 5 NRCSs (22, 24, 26, 27, 29) reported mortality at 6 months or later (Table 1; Supplement Table 5). Effect sizes ranged from 0.55 to 2.35, with no clear explanation for the heterogeneity (Figure 1). In the 4 RCTs, no statistically significant differences were found between PTRAS and medical therapy alone in all-cause mortality and cardiovascular mortality. Among the 5 NRCSs, only 1 found a statistically significantly reduced risk for death (45% with PTRAS vs. medical therapy) (26). Figure 1. Forest plot of effect size of death in adults w

An exploration of crowdsourcing citation screening for systematic reviews

Systematic reviews are increasingly used to inform health care decisions, but are expensive to produce. We explore the use of crowdsourcing (distributing tasks to untrained workers via the web) to reduce the cost of screening citations. We used Amazon Mechanical Turk as our platform and 4 previously conducted systematic reviews as examples. For each citation, workers answered 4 or 5 questions that were equivalent to the eligibility criteria. We aggregated responses from multiple workers into an overall decision to include or exclude the citation using 1 of 9 algorithms and compared the performance of these algorithms to the corresponding decisions of trained experts. The most inclusive algorithm (designating a citation as relevant if any worker did) identified 95% to 99% of the citations that were ultimately included in the reviews while excluding 68% to 82% of irrelevant citations. Other algorithms increased the fraction of irrelevant articles excluded at some cost to the inclusion of relevant studies. Crowdworkers completed screening in 4 to 17 days, costing

Effectiveness of Tympanostomy Tubes for Otitis Media: A Meta-analysis

460 to

Prevention and Treatment of Tympanostomy Tube Otorrhea: A Meta-analysis

2220, a cost reduction of up to 88% compared to trained experts. Crowdsourcing may represent a useful approach to reducing the cost of identifying literature for systematic reviews.

Comparative Effectiveness and Safety of Bariatric Procedures in Medicare-Eligible Patients: A Systematic Review

This article presents a systematic review of the effectiveness of tympanostomy tubes in children with chronic serous otitis media and recurrent acute otitis media, as well as their associated adverse events. CONTEXT: Tympanostomy tube placement is the most common ambulatory surgery performed on children in the United States. OBJECTIVES: The goal of this study was to synthesize evidence for the effectiveness of tympanostomy tubes in children with chronic otitis media with effusion and recurrent acute otitis media. DATA SOURCES: Searches were conducted in Medline, the Cochrane Central Trials Registry and Cochrane Database of Systematic Reviews, Embase, and the Cumulative Index to Nursing and Allied Health Literature. STUDY SELECTION: Abstracts and full-text articles were independently screened by 2 investigators. DATA EXTRACTION: A total of 147 articles were included. When feasible, random effects network meta-analyses were performed. RESULTS: Children with chronic otitis media with effusion treated with tympanostomy tubes compared with watchful waiting had a net decrease in mean hearing threshold of 9.1 dB (95% credible interval: −14.0 to −3.4) at 1 to 3 months and 0.0 (95% credible interval: −4.0 to 3.4) by 12 to 24 months. Children with recurrent acute otitis media may have fewer episodes after placement of tympanostomy tubes. Associated adverse events are poorly defined and reported. LIMITATIONS: Sparse evidence is available, applicable only to otherwise healthy children. CONCLUSIONS: Tympanostomy tubes improve hearing at 1 to 3 months compared with watchful waiting, with no evidence of benefit by 12 to 24 months. Children with recurrent acute otitis media may have fewer episodes after tympanostomy tube placement, but the evidence base is severely limited. The benefits of tympanostomy tubes must be weighed against a variety of associated adverse events.

Treatments of Primary Basal Cell Carcinoma of the Skin: A Systematic Review and Network Meta-analysis

A systematic review of need for water precautions and the effectiveness of otorrhea treatment with topical drops versus oral antibiotics in children with tympanostomy tubes. CONTEXT: Children with tympanostomy tubes often develop ear discharge. OBJECTIVE: Synthesize evidence about the need for water precautions (ear plugs or swimming avoidance) and effectiveness of topical versus oral antibiotic treatment of otorrhea in children with tympanostomy tubes. DATA SOURCES: Searches in Medline, the Cochrane Central Trials Registry and Cochrane Database of Systematic Reviews, Excerpta Medica Database, and the Cumulative Index to Nursing and Allied Health Literature. STUDY SELECTION: Abstracts and full-text articles independently screened by 2 investigators. DATA EXTRACTION: 25 articles were included. RESULTS: One randomized controlled trial (RCT) in children assigned to use ear plugs versus no precautions reported an odds ratio (OR) of 0.68 (95% confidence interval, 0.37–1.25) for >1 episode of otorrhea. Another RCT reported an OR of 0.71 (95% confidence interval, 0.29–1.76) for nonswimmers versus swimmers. Network meta-analyses suggest that, relative to oral antibiotics, topical antibiotic–glucocorticoid drops were more effective: OR 5.3 (95% credible interval, 1.2–27). The OR for antibiotic-only drops was 3.3 (95% credible interval, 0.74–16). Overall, the topical antibiotic–glucocorticoid and antibiotic-only preparations have the highest probabilities, 0.77 and 0.22 respectively, of being the most effective therapies. LIMITATIONS: Sparse randomized evidence (2 RCTs) and high risk of bias for nonrandomized comparative studies evaluating water precautions. Otorrhea treatments include non–US Food and Drug Administration approved, off-label, and potentially ototoxic antibiotics. CONCLUSIONS: No compelling evidence of a need for water precautions exists. Cure rates are higher for topical drops than oral antibiotics.

Strategies for improving the lives of US women aged 40 and above living with HIV/AIDS: an evidence map

Importance The prevalence of obesity in patients older than 65 years is increasing. A substantial number of beneficiaries covered by Medicare meet eligibility criteria for bariatric procedures. Objective To assess the comparative effectiveness and safety of bariatric procedures in the Medicare-eligible population. Evidence Review This systematic review was conducted according to the PRISMA guidelines. Articles were identified through searches of PubMed, Embase, CINAHL, PsycINFO, Cochrane Central Trials Registry, Cochrane Database of Systematic Reviews, and scientific information packages from manufacturers, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, and US Food and Drug Administration drugs and devices portals from January 1, 2000, to June 31, 2017. Randomized and nonrandomized comparative studies that evaluated bariatric procedures in the Medicare-eligible population were eligible. Six researchers extracted data on design, interventions, outcomes, and study quality. Findings were synthesized qualitatively; a planned meta-analysis was not undertaken owing to clinical heterogeneity. Findings A total of 11 455 citations were screened for eligibility. Of those, 16 met the eligibility criteria. Compared with no surgery or conventional weight-loss treatment, bariatric surgery results in greater weight loss. Overall mortality after 30 days is lower among bariatric patients (hazard ratio, HR, 0.50; 95% CI, 0.31-0.79, in the study with the longest follow-up of 5.9 years), although, based on 1 study, mortality within 30 days of surgery was higher than in nonsurgically treated controls (1.55% vs 0.53%; P < .001). Bariatric surgery is associated with lower risk of cardiovascular disease (HR, 0.59; 95% CI, 0.44-0.79 in the largest study comparison) and with improvements in respiratory, musculoskeletal, metabolic, and renal outcomes (increase in estimated glomerular filtration rate, 9.84; 95% CI, 8.05-11.62 mL/min/1.73m2). Compared with sleeve gastrectomy (SG) and adjustable gastric banding (AGB), Roux-en-Y gastric bypass (RYGB) appears to be associated with greater weight loss (percent excess weight loss, 23.8% [95% CI, 16.2%-31.4%] at the longest follow-up of 4 years) but the 3 procedures have similar associations with most non–weight loss outcomes. Overall postoperative complications are not statistically significantly different between RYGB and SG, although major and/or serious complications are more common after RYGB. However, these associations are susceptible to at least moderate risk of confounding, selection, or measurement biases. Conclusions and Relevance In the Medicare population, there is low to moderate strength of evidence that bariatric surgery as a weight loss treatment improves non–weight loss outcomes. Well-designed comparative studies are needed to credibly determine the treatment effects for bariatric procedures in this patient population.

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series

Basal cell carcinoma (BCC) is the most common cancer in the United States, with an annual incidence approaching 2 million cases (1). Most cases are not aggressive, but the tumors and their treatment can cause disfigurement or disability, which can adversely affect quality of life (2). The Surgeon Generals recent call to action to prevent skin cancer at the population level emphasizes the public health importance of dealing with BCC (3). Choosing a management strategy for an individual patient with a specific type of BCC from among the many available interventions is complex. Considerations include patient factors (such as age, frailty, immunosuppression, and personal preference), tumor factors (such as histologic subtype, size, and location), and the availability and cost of health care resources. The lack of clarity about the comparative efficacy and safety of the available options overall and in specific circumstances further complicates treatment decision making for both physicians and patients. Surgical removal is widely considered the gold standard and is therefore the most common treatment. However, despite several dozen randomized controlled trials (RCTs) and nonrandomized comparative studies (NRCSs), the relative performance of various surgical techniques and other therapeutic options is unclear. Payers are faced with increased use of costly therapies, such as brachytherapy, without clear evidence about relative benefits to justify increased costs (4). The purpose of this systematic review and network meta-analysis is to evaluate the comparative effectiveness and safety of treatments of primary BCC. Methods This article updates and summarizes the findings on BCC from a comparative effectiveness review for the Agency for Healthcare Research and Quality (AHRQ) on treatments of BCC and cutaneous squamous cell carcinoma (4). We followed the approach outlined in the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews (5). The protocol was developed with input from stakeholders (providers, researchers, payers, patients, and funders) and was prospectively registered with PROSPERO (CRD42016043353). Data Sources and Searches We searched PubMed, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Embase up to 8 May 2018 to identify eligible studies (the full report [4] gives search strategies, search terms, and search and selection figures). We queried ClinicalTrials.gov (most recently in August 2016) to identify ongoing or completed yet unpublished trials. We limited searches to English-language publications and supplemented them with suggestions from stakeholders and by perusing reference lists of eligible articles and of pertinent systematic reviews and guidelines. Study Selection We screened titles, abstracts, and full texts of eligible studies in duplicate. The population of interest was adult patients with primary BCC. Patient subgroups were specified in the protocol and were defined by tumor location (such as face, hands, trunk, or extremities) and histologic subtype (such as superficial or nodular BCC). We excluded subpopulations with rare genetic disorders associated with increased BCC risk (for example, basal cell nevus syndrome). With input from stakeholders, we identified 22 eligible interventions, which we organized into 9 categories (Table 1). Outcomes of interest included tumor recurrence and lack of histologic tumor clearance (proxies for failure to cure), cosmetic appearance (patient- or observer-reported), quality of life, mortality, and costs. Table 1. Intervention Categories and Specific Interventions We evaluated RCTs and comparative NRCSs. We included NRCSs only if they took steps to control for patient- or lesion-level confounders. We excluded studies that had fewer than 5 lesions per treatment group. Data Extraction and Risk-of-Bias Assessment One reviewer extracted information from eligible studies, and a second reviewer verified the extraction. Any disagreements were resolved by discussion among the team. Data extractions were done on and are publicly accessible through the Systematic Review Data Repository (http://srdr.ahrq.gov) (6). We recorded information on country of origin; population (mean age; sex distribution; and lesion histology, size, and location); interventions; outcomes (at the longest follow-up and at the follow-up closest to but not longer than 2 years); funding source; and attributes of study design, conduct, and analysis addressed in the Cochrane Risk of Bias Tool (7). For RCTs, at least 2 reviewers critically examined sources of bias and their likely effect and finalized their assessments in discussions with the whole team. We examined the effect of missing data by calculating mathematical bounds for effect estimates (8). This was accomplished by examining extreme scenarios in which all missing observations in one group had the outcome of interest and all missing observations in another group did not. For lack of histologic clearance, input from a pathologist informed our assessments of whether each treatment can be successfully masked. For each observational study, we used the Newcastle-Ottawa Scale (9) to guide our deliberations about sources and risk of bias. Data Synthesis, Analysis, and Assessments of Strength of Evidence We summarized all studies qualitatively and described important features of the population (including tumor characteristics), design, intervention, outcomes, and results. In each outcome, the evidence comprises 1 or more connected networks of 2 or more treatments. For each connected network in each outcome, we did frequentist (maximum likelihood) pairwise and network meta-analyses with mixed-effects (random intercepts and fixed intervention slopes) or full random-effects (random intercepts and slopes) multilevel models within the generalized linear and latent mixed-model framework. The network meta-analysis approach models the proportion of events in each trial group and thus can estimate not only the mean treatment effects (odds ratios) between treatments but also the mean proportion of events with each treatment using all of the available data. In Part G of the Supplement, we describe the models and their estimation and provide access to the data and code. Supplement. Supplementary Material We assessed consistency qualitatively and deemed direct and indirect effects to be in agreement when they were in the same direction and the CI of one included the point estimate of the other. We also used a node-split approach to assess for consistency quantitatively (10). In main analyses, we included data from the longest follow-up for each outcome in each trial. We excluded trials that compared versions of the same intervention (for example, different imiquimod treatment schedules). When data were available, we did subgroup analyses by lesion histologic subtype, location, and size (not shown) (4). The unit of analysis was the patient. A minority of studies reported results about lesions (where individual patients had several lesions), which were included as if each lesion belonged to a different patient. We did not correct for clustering of lesions by patient because the requisite estimates of intraclass correlation coefficients were not available. In sensitivity analyses, we included only trial data on outcomes closest to 1 year within the window of 0 to 2 years, and we fitted network meta-analysis models in the Bayesian framework (not shown). Network meta-analyses of intervention categories were congruent with the main analyses that focused on specific interventions (not shown). All analyses were done in R, version 3.4.4, using the igraph, lme4, metafor, and gemtc packages (1115). We report 95% CIs with no corrections to control for type I error. We summarized analyses as key findings and assessed the overall strength of evidence in terms of the risk of bias of the associated evidence base and the directness, precision, and consistency of the evidence, following the AHRQ methods guidance. Role of the Funding Source This report is based on research conducted by the Brown Evidence-based Practice Center under contract to the AHRQ. The funders role was limited to ensuring adherence to administrative requirements, including timelines and fidelity to the written protocol. The AHRQ was not involved in the design, conduct, or interpretation of the analyses. Results The literature searches returned 16154 citations, of which 519 were retrieved and screened in full text. Forty RCTs and 5 NRCSs were eligible (Supplement Figure and Supplement Tables 1 and 2). The randomized evidence base is sparse (Part B of the Supplement). Across all outcomes, the RCTs examined 18 interventions and provided data on 34 head-to-head comparisons, out of 153 possible comparisons. Of the 34 comparisons, 33 were informed by at most 3 trials. The evidence graphs in Figures 1, 2, 3, and 4 depict the head-to-head comparisons in RCTs for recurrence, lack of histologic clearance, and cosmetic outcomes assessed by patients and observers, respectively. They have the same layout to show the partial coverage of the evidence base per outcome. For all outcomes, the evidence base comprises between 2 and 4 connected networks. No comparisons are made between treatments that belong to unconnected networks, and each connected network is sparse. For example, in Figure 1, the largest connected network for recurrence comprises 14 treatments. Of these, 4 were compared with only 1 other treatment and 5 with only 2. Treatments that were compared with the most other treatments were surgical excision (n= 7) and photodynamic therapy (PDT) using methyl-aminolevulinic acid (n= 6). For lack of histologic clearance, aside from PDT using methyl-aminolevulinic acid (compared with 6 other treatments), all treatments were compared with at most 3 other treatments (6 treatments were compared with only 1 other treatment) (Figure 2). Figure 1. Ev

Global dietary calcium intake among adults: a systematic review

BackgroundWhile in its early years the HIV epidemic affected primarily the male and the young, nowadays, the population living with HIV/AIDS is approximately 24% women, and its age composition has shifted towards older ages. Many of the older women who live with HIV/AIDS also live with the medical and social conditions that accompany aging. This work aims to identify and characterize empirical studies of strategies for the comprehensive management of women over 40, including transgender women, who live with HIV/AIDS. Forty was chosen as an operational age cutoff to identify premenopausal women who are less likely to bear children, as well as peri- and postmenopausal women.MethodsWe conducted a literature search after discussions with a diverse panel of content experts and other stakeholders and developed an evidence map that identified 890 citations that address questions having to do with programs and barriers to engaging with programs, as well as the role of insurance and comorbidities, and have enrolled older women who live with HIV/AIDS.ResultsOf these, only 37 (4%) reported results of interest for women over 40 who live with HIV/AIDS, or examined interactions between gender and older age that would allow predictions in this subgroup. Few of the 37 eligible studies focused on women facing obvious challenges, such as immigrants, transgender, physically abused, or those recently released from prison. No studies focused on women caring for dependents, including children and grandchildren, or those diagnosed after age 40.ConclusionThe evidence base that is directly applicable to women over 40 who live with HIV/AIDS in the USA is limited, and the research need is broad. We propose research prioritization strategies for this population.

Decision Aids for Cancer Screening and Treatment

BackgroundWe investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews.MethodWe considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review’s last literature search, screened the records using the review’s eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review.ResultsAcross the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov’s inception date of 2000.ConclusionImproved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.