French Version of POMI Scale

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Completed
CT.gov ID
NCT04979364
Collaborator
University Hospital, Toulouse (Other)
154
28

Study Details

Study Description

Brief Summary

French translation and validation of the Prescription Opioid Misuse Index scale (POMI), a brief questionnaire to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic non-cancer pain (CNCP), this tool is particularly interesting to use during medical consultations to screen misuse in opioids user patients. We conducted an observational, prospective and multicenter psychometric study with a cross-cultural validation in 154 CNCP patients treated by opioid at least from 3 months, in two pain clinics.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Chronic pain prevalence in the general population was estimated at 31% in the world, which makes it a major public health problem, not only because of its enormous impact on patients' quality of life, but also because of its significant economic impact on society, with direct and indirect costs. Despite the lack of scientific evidence demonstrating their long-term benefits, analgesic opioids are largely used for treating chronic non-cancer pain (CNCP) lead to an increase of opioid use in recent decades in developed countries. Indeed, worldwide, opioid analgesic prescription use more than doubled from 2001 to 2013, most significantly in North America and in Western and Central Europe. Between years 2004 and 2017 in France, while overall analgesic opioid prescription use in the general population decreased by 8.9%, the used strong opioids increased by 104%. The same finding about increase in the use strong opioids was made in USA, Canada and UK. However, the use of opioid analgesics is not without risk, several international studies showed an increase opioid use disorders, hospitalizations and deaths related to the use of opioid analgesics. In France, rates of prescribed opioid-related hospital admissions increased by 167% from 2000 to 2017 and opioid-related deaths significantly increased by 146% (1,3 à 3,2 deaths / 1,000,000 habitants from 2000 to 2015). A similar observation can be made in the United States, where deaths from prescription opioid overdose have risen sharply in recent years, but in a much higher proportion than in France (in 2016 in the U.S., more than 42,000 overdose deaths, or an annual prevalence of 133 deaths/1,000,000 population).

    In the context of CNCP, opioid analgesics are subject to increasing misuse in relation to a greater number of prescriptions but also through other sources of obtaining (doctor shopping) hat may contribute to the increase in risks associated with the use of opioid analgesics (hospitalization, death). Few studies in France, assessed the misuse of analgesic opioids, based on the evaluation of "doctor shopping" from healthcare databases, and particularly, Chenaf et al., showed an increase of analgesic opioids shopping behavior by 34%, between 2004 to 0.67% in 2017. It is therefore important to be able to identify analgesic opioid misuse. Actually Prescription Opioid Misuse Index (POMI) scale was validated in 2008 by American team in 137 patients recruited from community substance abuse treatment programs, regional jails, pain clinics and private internal medicine practices.

    The primary objective was the cross-cultural validation of French version of an opioid analgesic misuse screening scale (POMI) in chronic pain patients in primary care. The secondary objective was the assessment of the relationship between pain intensity and analgesic opioid misuse.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    154 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Transcultural Validation of a French Version of the Prescription Opioid Misuse Idex Scale (POMI-5F)
    Actual Study Start Date :
    Sep 1, 2015
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    Dec 31, 2017

    Outcome Measures

    Primary Outcome Measures

    1. psychometric properties of POMI scale [Once. Day 1]

      Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F). POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.

    2. psychometric properties of POMI scale [Once. At 2 to 4 weeks (Re-TEST phase)]

      Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F). POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients aged 18 or more, suffered from chronic non-cancer pain for at least 6 months, with at least one analgesic opioid daily for 3 months, and follow in pain clinic.
    Exclusion Criteria:
    • inability to read or understand questionnaires alone, cancer, and impossibility to do test and retest questionnaires.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand
    • University Hospital, Toulouse

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT04979364
    Other Study ID Numbers:
    • POMI
    First Posted:
    Jul 28, 2021
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2022