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

April 14, 2020 updated by: Member Companies of the Opioid PMR Consortium

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Evidera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic pain recruited from primary care or chronic pain clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content validity of POMAQ
Time Frame: 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
Day 1, based upon survey completed at single visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Member Companies of the Opioid PMR Consortium

Collaborators

Evidera

Investigators

  • Study Chair: Alexandra Barsdorf, Ph.D., Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2015

Primary Completion (Actual)

January 18, 2016

Study Completion (Actual)

January 18, 2016

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Observational Study 3033-3
  • 3033-3 (Other Identifier: Member Companies of the Opioid PMR Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid-Related Disorders

Clinical Trials on Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe