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Systematic review of the literature identified 14 studies of 9 instruments assessing patient-reported safety, efficacy, or misuse of current opioid therapy for chronic pain, none of which had been tested in clinical practice.The purpose of this systematic review was to summarize and critically appraise research developing or validating instruments to assess patient-reported safety, efficacy, and/or misuse in ongoing opioid therapy for chronic pain. Our search included the following datasets: OvidSP MEDLINE (1946-August 2012), OvidSP PsycINFO (1967-August 2012), Elsevier Scopus (1947-August 2012), OvidSP HaPI (1985-August 2012), and EBSCO CINAHL (1981-August 2012). Eligible studies were published in English and pertained to adult, nonsurgical/interventional populations. Two authors independently assessed inclusion criteria. Each study was evaluated by 2 authors to assess the sources and content of items, types of psychometric tests, their results, and quality of diagnostic accuracy testing, when applicable. Of 1874 citations found in the initial search, we identified 14 studies meeting our inclusion criteria, describing 9 different instruments. Individual items were derived from surveys of content experts, literature reviews, and adapted non-patient-reported items. Misuse-related items were most prevalent (60/144; 42%), followed by safety (47/144; 33%), with efficacy having the fewest items (17/144; 12%). The studies employed a wide variety of psychometric tests, with most demonstrating statistical significance, but several potential sources of bias and generalizability limitations were identified. Lack of testing in clinical practice limited assessment of feasibility. The dearth of safety and efficacy items and lack of testing in clinical practice demonstrates areas for further research.