A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire

Completed

• Conditions: Opioid-Related Disorders; Opiate Addiction; Drug Abuse; Narcotic Abuse
• Interventions: Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

• Registration Number: NCT02660606
• Lead Sponsor: Member Companies of the Opioid PMR Consortium

Brief Summary

The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users

Detailed Description

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.

Currently, no tool exists to meet this need except for the Self-report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of prior content validation. The SR-MAD has been 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).

This study will seek to further develop and validate the POMAQ using the the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) as a reference for conducting qualitative research throughout the process of instrument development to ensure the content validity of a measure and to evaluate the comprehensibility of included questions. This qualitative study to evaluate content validity will be conducted prior to the quantitative study to evaluate construct validity

Study Timeline

• Study Start: 2015-01-02
• Study First Submitted: 2016-01-14
• Primary Completion: 2016-01-18
• Study Completion: 2016-01-18
• Study First Submitted QC: 2016-01-18
• Study First Posted: 2016-01-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Age ≥ 18 years
2. Patients who, based on the Site Investigator's clinical judgment, have chronic moderate to severe pain
3. Willing to provide written informed consent
4. Able to participate in a one-on-one interview
5. Able to read, speak, and understand English and complete all study assessments.

Exclusion Criteria

1. Cognitive, psychiatric or other impairment based on the Site Investigator's clinical judgment that would interfere with participating in a one-on-one discussion
2. Terminal illness with life expectancy < 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3: Non-opioid abusers	Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)	-
Group 1: Opioid abusers	Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)	-
Group 4: Non-opioid users	Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)	-
Group 2: Abusers of other substances	Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)	-

Primary Outcome Measures

Name	Time	Method
Content validity of POMAQ	Day 1, based upon survey completed at single visit	Evidence of content validity from patients regarding the interpretation of POMAQ items, ease of completion, the comprehensiveness of instrument, and the appropriateness of the format, response scales, and recall period

Trial Locations

Locations (1)

Evidera; 🇺🇸 Bethesda, Maryland, United States