A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
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
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
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
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
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.
We found this trial at
1
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