Clinical scoring algorithm for the prescription opioid misuse and abuse questionnaire (POMAQ)

Abstract

Objective

The Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) was developed to identify prescription opioid misuse and abuse among patients with chronic pain. A clinical scoring algorithm was developed and refined to align with the patient experience.

Methods

This study utilized data from the POMAQ validation study (3033-4, NCT02660606) conducted on a sample of patients with chronic pain living in the United States. The study was carried out in two phases. Two purposefully enriched patient samples, one for each phase, were created based on patient responses to select POMAQ items and the availability of urine and hair samples. Two clinical experts (SHS, SFB) reviewed patient data to classify prescription opioid use behavior. Classification differences were adjudicated by a third clinical expert (JTF). Comparisons were made between the final clinical classification determined by the experts and the proposed classification based on the POMAQ algorithm.

Results

Sixty patients were included in Phase I (only POMAQ data) and 52 in Phase II (including POMAQ and ancillary sources [e.g. electronic medical records, urine toxicity screen]). Refinements were made to the POMAQ scoring algorithm following discussions with clinical experts to ensure it was clinically relevant. For both phases, classifications were reviewed and discussed to achieve maximal concordance of classifications across experts. The proposed scoring algorithm was then modified to maximize agreement with the expert interpretation of clinically relevant patient experiences.

Conclusion

The clinical scoring algorithm for the POMAQ was developed and refined to reflect clinically relevant patient behaviors identified by expert review. Future testing is needed to determine the sensitivity and specificity of this measure.

Keywords:

• Scoring algorithm
• misuse
• abuse
• chronic pain
• opioid
• patient-reported outcome

Transparency

Declaration of funding

This project was conducted as part of a Food and Drug Administration (FDA)-required post-marketing study for extended-release and long-acting opioid analgesics and was funded by the Opioid Postmarketing Consortium (OPC) consisting of the following companies: Allergan; Assertio Therapeutics, Inc.; BioDelivery Sciences, Inc.; Collegium Pharmaceutical, Inc.; Daiichi Sankyo, Inc.; Egalet Corporation; Endo Pharmaceuticals, Inc.; Hikma Pharmaceuticals USA Inc.; Janssen Pharmaceuticals, Inc.; Mallinckrodt Inc.; Pernix Therapeutics Holdings, Inc.; Pfizer, Inc.; Purdue Pharma, LP.

Declaration of financial/other relationships

KS Coyne and BM Currie are employees of Evidera, a company that received funding from the OPC to conduct this study. At the time of the study, AI Barsdorf was employed by Pfizer, a member company of the OPC. At the time of the study, JY Mazière was an employee of PPD, a parent company to Evidera and is now an employee of Astellas. RF Pierson is an employee of Janssen, a member company of the OPC. SH Schnoll is an employee of Pinney Associates, a company that received funding from the OPC for time spent as an expert reviewer for this study. SF Butler received funding from the OPC for time spent as an expert reviewer for this study. JT Farrar is an employee of the University of Pennsylvania and received funding from the OPC for time spent as an expert reviewer for this study to support his salary. L Porter is an employee of Health ResearchTx, a company that received funding from the OPC to conduct this study. All aspects of the study design, interpretation, and decision to submit for publication were determined by the authors. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

KSC, AIB, JYM, RFP, SHS, SFB, and JTF were involved in the conception and design of the study, analysis and interpretation of the data, drafting of the manuscript and revising it critically for intellectual content. BJG, LNP and BMC were involved with data collection, data interpretation, drafting of the manuscript and revising it critically for intellectual content. All authors provided final approval of the version to be published.

Acknowledgements

Research data derived from approved Naval Medical Research Unit-Dayton, Dayton, Ohio and Naval Medical Center, Portsmouth, Virginia IRB, protocol; number NAMRUD.2015.0004. The views expressed in this article are those of the author(s) and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States Government. CDR Michael Franks Jr. is a member of the U.S. Military. This work was prepared as part of his official duties. Title 17 U.S.C. 105 provides that "Copyright protection under this title is not available for any work of the United States Government." Title 17 U.S.C. 101 defines a United States Government work as a work prepared by a military service member or employee of the United States Government as part of that person’s official duties.