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Abstract
Background: Establishing content validity is an essential component of instrument development.
Objective: To assess the content validity and patient interpretation of the Self-Reported Misuse, Abuse and Diversion of Prescription Opioids (SR-MAD) instrument.
Methods: A cross-sectional, qualitative study was conducted in patients with chronic or acute pain. Patients were recruited from three patient groups (opioid naïve, known opioid abusers, and chronic opioid non-abusers). After patients completed the SR-MAD, they participated in an in-person cognitive interview to assess the patient’s understanding of the instrument. Descriptive statistics and content analysis were performed.
Results: Fifty-seven patients (Wave 1: 20; Wave 2: 37) were enrolled and completed the SR-MAD and cognitive interview. Mean age was 54.5 ± 13.7 years (range 25–84) with 12.5 years of living with pain. The most common chronic pain conditions were back pain (68%), neck pain (32%), and osteoarthritis (25%). Overall, most patients understood the meaning of each question and were able to describe each item using their own words. Many patients reported that some questions were not applicable to them but understood the meaning of the questions as well as the need to ask questions about misuse, abuse, and diversion of opioid medications. Minor revisions to the SR-MAD wording, response options, recall period, and the definition of “opioid”, were recommended by the patients in both waves.
Limitations: Given its qualitative design, this study has a small sample size. Additionally, quantitative validation of the SR-MAD is needed.
Conclusion: The SR-MAD, developed based on expert consensus and revised with patient input, is a 15-item self-report instrument that can be used to identify and monitor prescription opioid abuse, misuse, and diversion.
Transparency
Declaration of funding
Funding for this work was provided by Pfizer Inc.
Author contributions: All authors participated in data analysis and interpretation, and contributed to the development of the manuscript. The authors maintained control over the final contents of the manuscript and the decision to publish.
Declaration of financial/other relationships
B.S. has disclosed that she was a full-time employee of Pfizer at the time of the study. C.L.R. and A.I.B. have disclosed that they are employed by Pfizer. K.S.C. and A.B. have disclosed that they are employees of Evidera, who were paid consultants to Pfizer in connection with study and development of this manuscript.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Notes
1 Tylenol trade name is owned by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson. Fort Washington, Pennsylvania, USA.
2 Soma trade name is registered by Meda Pharmaceuticals Inc. Somerset, New Jersey, USA.
3 Lortab trade name is registered by UCB, Inc. Smyrna, Georgia, USA.