title: Initial development of patient-reported instrument assessing harm, efficacy, and misuse of long-term opioid therapy.
abstract: Guidelines on long-term opioid therapy recommend frequent reassessment of harm, efficacy, and misuse of these potentially harmful and sometimes ineffective medications. In primary care, there is a need for a brief, patient-reported instrument. This report details the initial steps in the development of such an instrument. An interdisciplinary team of clinician-scientists performed four discrete steps in this study: (1) conceptualization of the purpose and function of the instrument, (2) assembly of an item pool, (3) expert rating on which items were most important to include in the instrument, and (4) modification of expert-selected items based on a reading level check and cognitive interviews with patients. A diverse panel of 47 subject matter experts was presented with 69 items to rate on a 1-9 scale in terms of importance for inclusion in the instrument. The panel highly rated 37 items: 8 related to harm, 4 related to efficacy, and 25 related to misuse. These 37 items were then tested for patient comprehension and modified as needed. Next steps in development will include further item reduction, testing against a gold standard, and assessment of the instrument's effect on clinical outcomes.
authors.affiliation: Department of Veterans Affairs (VA) Connecticut Healthcare System, West Haven, CT;
authors.forename: William C
authors.initials: WC
authors.lastname: Becker
authors.forename: David A
authors.initials: DA
authors.lastname: Fiellin
authors.forename: Anne C
authors.initials: AC
authors.lastname: Black
authors.forename: Carol T
authors.initials: CT
authors.lastname: Kostovich
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
authors.forename: Liana
authors.initials: L
authors.lastname: Fraenkel
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects*; D059350:Chronic Pain / Q000188:drug therapy* / Q000523:psychology; D016903:Drug Monitoring / Q000592:standards*; D006801:Humans; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement / Q000379:methods; D017410:Practice Guidelines as Topic; D016730:Program Development / Q000592:standards*; D011594:Psychometrics; D011795:Surveys and Questionnaires; D013997:Time Factors
chemical_list: D000701:Analgesics, Opioid
keywords: chronic pain; efficacy; harm; instrument development; misuse; opioid analgesics; opioid therapy; pain management; patient reported; therapeutic monitoring