High Impact Chronic Pain (HICP) is defined as the presence of pain on at least half of days in the previous 3-6 months with substantial restriction of functional participation in work, social, and self-care activities. HICP is assessed with several questions assessing the duration, frequency, and impact of chronic pain, as well as one question regarding the impact of pain on work. In the PMC3, those who report pain on most days for the past 3 months, and who report that pain limits their life or work activities, are considered to have HICP.
We compared operational definitions (ICD9/10) that targeted a non-VA research setting (PROUD), a VA research setting (Seal et al., 2019) and non-research quality measurement system, the Healthcare Effectiveness Data and Information Set (HEDIS) and determined that there was overlap across SUD sub-categories of opioid use disorder, alcohol use disorder, other substance used disorders. Based on this review, Primary Care Opioid Use Disorders Treatment Trial (PROUD) was recommended as the phenotype for the PMC-3.
An early challenge was to ensure that PMC researchers across the 11 national, large-scale pain trials did not co-enroll participants in multiple, concurrent pain trials. Learn about the strategies developed to address this challenge.
In Learn as You Go (LAGO) study designs, the components of the complex package are repeatedly optimized in pre-planned stages, until the intervention package is optimized. In this manuscript, the authors explore the key features of the LAGO’ design, illustrated by the null BetterBirth study, a large-scale public health intervention trial. (DRAFT)
The 5-item PMC COVID-19 measure assesses five potential domains of pandemic impact: access to healthcare, social support, finances, ability to meet basic needs, and mental or emotional health. Two additional items assess infection status (personal and household) and hospitalization.
In surveys of patients with chronic pain, pain intensity is described as a critically important dimension of the pain experience and a crucial target of pain treatments (Turk et al., 2008). Moreover, panels of pain experts have suggested that “For most clinical trials of chronic pain treatments, a measure of pain intensity will provide the primary outcome measure.”
The International Association for the Study of Pain and ICD diagnoses of chronic pain use a minimum 3-
month threshold for establishing chronicity. For clinical trials
of treatments for chronic pain, IMMPACT recommends a 6-month minimum for pain duration, which we apply for this instrument.
The Patient Health Questionnaire-2 (PHQ-2) is a widely used, patient-reported, 2-item screening measure for depression.
The Alcohol Disorders Identification Test-Concise (AUDIT-C) is a brief alcohol use disorder screening instrument that reliably identifies individuals who are at risk for alcohol use disorder (including alcohol abuse or dependence).
The PEG is a brief, convenient, patient-reported pain outcome measure that is derived from the Brief Pain Inventory.