Enrollment, retention, and effective strategies for including disadvantaged populations in controlled trials: A systematic review protocol

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: CRD4202015281

Consumer Decision Making and Store Patronage Behaviour in Traditional Chinese Medicine (TCM) Halls in Singapore

This paper examines who patronises Traditional Chinese Medicine (TCM) halls in Singapore and for what purpose. A quantitative study of 400 respondents identifies that TCMs are used primarily for the improvement of health and well being rather than the treatment of more serious medical conditions. While the patronage of TCM stores is not restricted to the Chinese population, traditional Mom-and-Pop outlets have come under increasing pressure from new market entrants. When choosing a TCM outlet, customers consider price and quality to be important factors while trust in the store keeper was also identified as a key determinant of store choice

A Systematic Review and Meta-Analysis of Patient Decision Aids for Socially Disadvantaged Populations:Update from the International Patient Decision Aid Standards (IDPAS)

International audienceBackground. 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, Psy-cINFO, 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 [I 2 = 96%]) and patient-clinician communication (relative risk = 1.62, 95% CI 1.42, 1.84 [I 2 = 0%]). PtDAs reduced decisional conflict (mean difference = 29.59; 95% CI 218.94, 20.24 [I 2 = 84%]) and the proportion undecided (relative risk = 0.39; 95% CI 0.28, 0.53 [I 2 = 75%]). PtDAs did not affect anxiety (standardized mean difference = 0.02, 95% CI 20.22, 0.26 [I 2 = 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

Flexible Usage and Interconnectivity of Diverse Cell Death Pathways Protect against Intracellular Infection.

Programmed cell death contributes to host defense against pathogens. To investigate the relative importance of pyroptosis, necroptosis, and apoptosis during Salmonella infection, we infected mice and macrophages deficient for diverse combinations of caspases-1, -11, -12, and -8 and receptor interacting serine/threonine kinase 3 (RIPK3). Loss of pyroptosis, caspase-8-driven apoptosis, or necroptosis had minor impact on Salmonella control. However, combined deficiency of these cell death pathways caused loss of bacterial control in mice and their macrophages, demonstrating that host defense can employ varying components of several cell death pathways to limit intracellular infections. This flexible use of distinct cell death pathways involved extensive cross-talk between initiators and effectors of pyroptosis and apoptosis, where initiator caspases-1 and -8 also functioned as executioners when all known effectors of cell death were absent. These findings uncover a highly coordinated and flexible cell death system with in-built fail-safe processes that protect the host from intracellular infections.Wellcome Trus

A Systematic Review and Meta-Analysis of Patient Decision Aids for Socially Disadvantaged Populations:Update from the International Patient Decision Aid Standards (IDPAS)

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].</p

Enrollment, retention, and strategies for including disadvantaged populations in randomized controlled trials: a systematic review protocol

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

Origins of Social Parasitism: The Importance of Divergence Ages in Phylogenetic Studies

Phylogenetic studies on insect social parasites have found very close host-parasite relationships, and these have often been interpreted as providing evidence for sympatric speciation. However, such phylogenetic inferences are problematic because events occurring after the origin of parasitism, such as extinction, host switching and subsequent speciation, or an incomplete sampling of taxa, could all confound the interpretation of phylogenetic relationships. Using a tribe of bees where social parasitism has repeatedly evolved over a wide timescale, we show the problems associated with phylogenetic inference of sympatric speciation. Host-parasite relationships of more ancient species appear to support sympatric speciation, whereas in a case where parasitism has evolved very recently, sympatric speciation can be ruled out. However, in this latter case, a single extinction event would have lead to relationships that support sympatric speciation, indicating the importance of considering divergence ages when analysing the modes of social parasite evolution