Discussion Questions – HEALing Communities Study Design Workshop
Session 1: Study Design
- How can “heavily affected communities” be defined, including geospatial/geopolitical definitions to provide consistent boundaries for a multi-site study?
- What research designs might be appropriate to accomplish the overall goals of the study?
- How can effect size be estimated and what effect size might be expected in relation to candidate outcomes: rates of non-fatal and fatal overdose; prevalence and incidence of opioid misuse, OUD and Hepatitis C; percent of patients screened for opioid misuse and OUD and who received a brief intervention or were referred to treatment; percent of patients initiated on MAT and retained in medication treatment beyond 6 months; rates of naloxone distribution and overdose reversals; opioid analgesic and benzodiazepine prescription rates; and implementation of prevention programs?
- What baseline data should be captured and what are potential sources for this data?
- How long would an integrated set of evidence-based interventions need to be in place before expecting a meaningful change in outcomes?
- What confounding variables need to be considered?
- What are potential threats to internal and external study validity and what strategies could be deployed to mitigate threats?
- Are there particular strategies that can help the Coordinating Center overcome barriers to the facilitation of collaboration and coordination activities across Research Centers with regard to data harmonization, collection, integration, cleaning, analyses, and creating datasets for sharing with the research community at large?
Session 2: Outcomes
- What target metrics would be feasible for outcomes? Candidate outcomes could include but not limited to: rates of non-fatal and fatal overdose; prevalence and incidence of opioid misuse, OUD and Hepatitis C; percent of patients screened for opioid misuse and OUD and who received a brief intervention or were referred to treatment; percent of patients initiated on MAT and retained in medication treatment beyond 6 months; rates of naloxone distribution and overdose reversals; opioid analgesic and benzodiazepine prescription rates; and implementation of prevention programs?
- What is the best way to gather reliable data related to candidate outcomes listed above?