05/20/2020 12:00 AM EDT
Source: Yale University. Published: 5/20/2020. This 7-item self-report instrument is intended for individuals who are participating in ongoing clinical research during the coronavirus pandemic. It was developed to quantify changes in psychosocial, functional, and financial factors that may influence clinical research participation and clinical research study outcomes. The domains measured include: (1.) Access to Healthcare, (2.) Social Support, (3.) Finances, (4.) Ability to Meet Basic Needs, (5.) Mental and Emotional Health as well as a participant (subjective) experience of personal and family exposure to coronavirus. It was designed to quickly assess, in a minimally-burdensome manner, the positive and negative aspects of the pandemic on multiple mediating factors that may impact study outcomes. This instrument has a 3-month look back which can be adjusted to fit the study design. The tool is intended to be delivered at multiple time points (baseline and follow-up) to measure changes over time. This instrument was developed by researchers for the Pain Management Collaboratory (PMC) which involves 11 pragmatic trials studying non-pharmacological approaches to pain management (e.g. physical therapy, chiropractic care, meditation) in military personnel and veterans; however, this instrument was written broadly enough to be used with any adult population involved in clinical research. Questions Adapted From: The Phenotype and Outcome Work Group, within the Pain Management Collaboratory Coordinating Center (PMC3), is comprised of representatives from 11 pragmatic pain trials. The PMC3 collected COVID-related questionnaires from public sources, published instruments, and investigators within the Collaboratory. The Work Group members then met to review the resources compiled by PMC3, identified the key domains of interest, selected a question/response structure proposed for use by three PMC trial groups, revised the language within each question item until a consensus was obtained, and drafted the final instrument. This instrument has been approved by the Steering Committee for harmonized use of across PMC trials. Population: Adults Only Length: 7 items Time to complete: < 5 minutes Mode of Administration: Online (e.g., computer-assisted interview); Pen and Paper; Telephone Administered by: Self Administered Language: English (PDF)
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