A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire

The Food and Drug Administration (FDA) has requested, as part of a Post-marketing requirement (PMR) for new drug application (NDA) holders of extended release/long-acting (ER/LA) opioids, to conduct a study to develop and validate a measure of the opioid-related adverse events misuse and abuse among patients with chronic pain prescribed long-term opioid therapy. This measure will be used to assess misuse and abuse in PMR Study 2065-1A and PMR Study 2065-4B. To date, no tool currently exists to address the needs of the PMR except for the Self-Report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of content validation but requires further validation. The SR-MAD has been substantially modified to meet the needs of PMR Studies 2065-1A and 2065-4B and has been renamed the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). The POMAQ will undergo content validation via qualitative interviews (Protocol 2065-2A \[Qualitative\]) prior to use in this validation study (Protocol 2065-2A \[Quantitative\]). This quantitative study will seek to further develop and validate the POMAQ following the general tenants according to the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) which emphasizes the importance of conducting sound psychometric evaluation of patient-reported instruments through quantitative research methods. However, it should be noted that the POMAQ is not a typical PRO measure capturing a specific latent construct and the specified analytic approach to the POMAQ reflects this difference in theoretical frameworks.