Understanding Hispanic/Latino Participation in Clinical Trials and Observational Studies, and Strategies to Increase Participation: A Targeted Literature Review.

Hispanic/Latino representation in medical research remains poor. We describe factors affecting rates of recruitment, participation, adherence, and retention of Hispanics/Latinos in clinical studies in the United States and characterize proposed strategies to improve these rates. A targeted literature review was conducted.

Digital Devices for Assessing Motor Functions in Mobility-Impaired and Healthy Populations: Systematic Literature Review.

Background: With the advent of smart sensing technology, mobile and wearable devices can provide continuous and objective monitoring and assessment of motor function outcomes.

Objective: We aimed to describe the existing scientific literature on wearable and mobile technologies that are being used or tested for assessing motor functions in mobility-impaired and healthy adults and to evaluate the degree to which these devices provide clinically valid measures of motor function in these populations.

Methods: A systematic literature review was conducted by searching Embase, MEDLINE, CENTRAL (January 1, 2015, to June 24, 2020), the United States and European Union clinical trial registries, and the United States Food and Drug Administration website using predefined study selection criteria.

Customized guidance/training improved the psychometric properties of methodologically rigorous risk of bias instruments for non-randomized studies.

Objectives: To evaluate the impact of guidance and training on the inter-rater reliability (IRR), inter-consensus reliability (ICR) and evaluator burden of the Risk of Bias (RoB) in Non-randomized Studies (NRS) of Interventions (ROBINS-I) tool, and the RoB instrument for NRS of Exposures (ROB-NRSE).

Study Design And Setting: In a before-and-after study, seven reviewers appraised the RoB using ROBINS-I (n = 44) and ROB-NRSE (n = 44), before and after guidance and training. We used Gwet's AC statistic to calculate IRR and ICR.

Methodologically rigorous risk of bias tools for nonrandomized studies had low reliability and high evaluator burden.

Objective: To assess the real-world interrater reliability (IRR), interconsensus reliability (ICR), and evaluator burden of the Risk of Bias (RoB) in Nonrandomized Studies (NRS) of Interventions (ROBINS-I), and the ROB Instrument for NRS of Exposures (ROB-NRSE) tools.

Study Design And Setting: A six-center cross-sectional study with seven reviewers (2 reviewer pairs) assessing the RoB using ROBINS-I (n = 44 NRS) or ROB-NRSE (n = 44 NRS). We used Gwet's AC statistic to calculate the IRR and ICR.

Inter-rater reliability and validity of risk of bias instrument for non-randomized studies of exposures: a study protocol.

Background: A new tool, "risk of bias (ROB) instrument for non-randomized studies of exposures (ROB-NRSE)," was recently developed. It is important to establish consistency in its application and interpretation across review teams. In addition, it is important to understand if specialized training and guidance will improve the reliability in the results of the assessments.