The coronavirus disease 2019 pandemic has required health care systems to radically and rapidly rethink the delivery of care. One of the most remarkable ongoing changes has been the unprecedented accelerated expansion of telehealth. The pandemic may provide the incentive needed to realize the potential of telehealth. Nevertheless, concerns remain that safety and privacy may be compromised by rapid deregulation, despite data, although limited, regarding good overall quality. 1 In studies conducted before the COVID-19 pandemic, patients reported high levels of satisfaction. 2 This Viewpoint describes some of the most important telehealth regulatory changes that have occurred in response to COVID-19 and discusses some of the opportunities and challenges inherent in successfully harnessing the unexpected expanded role recently given to telehealth in the US.
Background The effectiveness of patient decision aids (PtDAs) and other shared decision-making (SDM) interventions for socially disadvantaged populations has not been well studied. Purpose To assess whether PtDAs and other SDM interventions improve outcomes or decrease health inequalities among socially disadvantaged populations and determine the critical features of successful interventions. Data Sources MEDLINE, CINAHL, Cochrane, PsycINFO, and Web of Science from inception to October 2019. Cochrane systematic reviews on PtDAs. Study Selection Randomized controlled trials of PtDAs and SDM interventions that included socially disadvantaged populations. Data Extraction Independent double data extraction using a standardized form and the Template for Intervention Description and Replication checklist. Data Synthesis Twenty-five PtDA and 13 other SDM intervention trials met our inclusion criteria. Compared with usual care, PtDAs improved knowledge (mean difference = 13.91, 95% confidence interval [CI] 9.01, 18.82 [I2 = 96%]) and patient-clinician communication (relative risk = 1.62, 95% CI 1.42, 1.84 [I2 = 0%]). PtDAs reduced decisional conflict (mean difference = −9.59; 95% CI −18.94, −0.24 [I2 = 84%]) and the proportion undecided (relative risk = 0.39; 95% CI 0.28, 0.53 [I2 = 75%]). PtDAs did not affect anxiety (standardized mean difference = 0.02, 95% CI −0.22, 0.26 [I2 = 70%]). Only 1 trial looked at clinical outcomes (hemoglobin A1C). Five of the 12 PtDA studies that compared outcomes by disadvantaged standing found that outcomes improved more for socially disadvantaged participants. No evidence indicated which intervention characteristics were most effective. Results were similar for SDM intervention trials. Limitations Sixteen PtDA studies had an overall unclear risk of bias. Heterogeneity was high for most outcomes. Most studies only had short-term follow-up. Conclusions PtDAs led to better outcomes among socially disadvantaged populations but did not reduce health inequalities. We could not determine which intervention features were most effective. [Box: see text]
Background Many randomized controlled trials fail to reach their target sample size. When coupled with the omission and underrepresentation of disadvantaged groups in randomized controlled trials, many trials fail to obtain data that accurately represents the true diversity of their target population. Policies and practices have been implemented to increase representation of disadvantaged groups in many randomized controlled trials, with some trials specifically targeting such groups. To our knowledge, no systematic review has quantified the enrollment metrics and effectiveness of inclusion and retention strategies in randomized controlled trials focused on disadvantaged populations specifically. Methods We will conduct a systematic search across EMBASE, MEDLINE, Web of Science, and CINAHL as well as grey literature, conference proceedings, research monographs, and Google Scholar from inception onwards. We will include randomized controlled trials where at least 50% of enrolled participants are considered to be disadvantaged, as per the RCT authors’ definition and in line with our inclusion criteria. Two independent researchers per article will conduct preliminary title and abstract screening, subsequent full text review, and data extraction for the selected trials, with a third reviewer available to resolve conflicts. We will assess the quality of all included studies using specific criteria regarding data reporting, external validity, and internal validity. We will combine all selected studies and conduct a narrative synthesis to assess enrollment metrics. If there is sufficient homogeneity and sufficient trials comparing recruitment strategies within disadvantaged populations, we will conduct a random effects meta-analysis to evaluate the effectiveness of strategies designed to maximize the inclusion of disadvantaged populations in randomized controlled trials. Discussion The findings of this systematic review will establish baseline recruitment and enrollment metrics of trials targeting disadvantaged populations to elucidate the scope of the challenge of recruiting such populations. We hope that our findings will promote future research on the distinct barriers that may prevent disadvantaged populations from participating in health intervention research, will encourage more trials exploring effective, tailored recruitment strategies, and will establish a foundation to track future progress in the recruitment of disadvantaged populations. Trial registrations PROSPERO ID: CRD42020152814
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