ABSTRACT
Objective: To examine how the COVID-19 pandemic impacts the behavioral health of people with intellectual and/or developmental disabilities (IDD) in the US. Background: The general population has suffered increasing rates of mental health problems during the COVID-19 pandemic. Having an intellectual disability was the most significant independent risk factor for a diagnosis of COVID-19, and the second strongest independent risk factor to COVID-19 mortality. This study investigates how the pandemic uniquely impacted the behavioral health of people with IDD. Design/Methods: Data were collected using a modified version of the Coronavirus Health Impact Survey -Adapted for Autism and Related Neurodevelopmental conditions (CRISISAFAR). The survey was disseminated electronically to a non-probability (i.e., convenience) sample of community and advocacy groups through the authors' networks of IDD-affiliated organizations. Study data were collected and managed using REDCap electronic data capture tools from March to June 2021. Results: 437 individuals with IDD completed the survey. 52.2% listed having an intellectual disability and 48.7% listed autism spectrum disorder, among other diagnoses. 51.6% of the survey population reported that their mental health had worsened during the pandemic. 47.6% said that they were worrying more, 55.6% struggled with changes in routine, and 18.7% reported increased self-injurious behavior. Losing access to services and programs correlated with declining mental health. Loss of or decrease in community support also correlated with increased screen time, worse sleep, and needing more help with activities of daily living. Conclusions: The behavioral health of individuals with IDD was profoundly impacted by the changes caused by COVID-19. Despite pervasive needs for increased mental and physical health resources amongst individuals with IDD, the potential positive impact of physical activity and pandemic safe social supports and opportunities should be regarded as an important and accessible means to mitigate the overall gap in services.
ABSTRACT
Background and objective: The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. Methods: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. Results and conclusions: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias. © 2021, College of Intensive Care Medicine. All rights reserved.