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      Impact of Removing Nonprescription Codeine in Australia: Protocol for a Prospective Cohort Study

      , MClinPsych 1 , , , PhD 2 , , PhD 1
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      codeine, opioids, dependence, rescheduling, drug policy

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          On February 1, 2018, Australia rescheduled codeine to a prescription-only medication. Many concerns were associated with this change, including increased financial costs, reduced service accessibility, the potential for poorer pain management, and a decline in physical and mental health if codeine could not be accessed. In the research literature, there is limited knowledge about the long-term consequences of rescheduling pharmaceutical opioids and, as Australia has followed many countries in implementing a restriction on codeine, further study of these consequences is critical.


          The goal of this study was to examine the impact of rescheduling codeine from an over-the-counter (OTC) product to a prescription-only medicine on the primary measures of codeine use and dependence in a prospective cohort of people who are frequent consumers of OTC codeine. Secondary measures included pain and self-efficacy, health service use, and mental health.


          The Codeine Cohort study aimed to recruit 300 participants in Australia who regularly (at least a few times per week for the past 6 months) used OTC codeine. Using an online survey, participants were followed up at three time points (February 2018, June 2018, and February 2019) after codeine was rescheduled.


          All four waves of data collection are complete, with the final round of data collection finalized in August 2019. Data analyses are yet to be completed. Information on demographics, codeine use and dependence, physical and mental health, medication use, and health service use will be analyzed using mixed models.


          Results of this study will provide insight into the effectiveness of regulatory restriction in curtailing nonmedical use of and harms associated with codeine. Additionally, results will explore positive and negative outcomes of codeine rescheduling for individual patients, which informs health professionals who support patients who use codeine and further community education.

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          Most cited references61

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          Monitoring depression treatment outcomes with the patient health questionnaire-9.

          Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring, an efficient method for assessing treatment outcome is lacking. We investigated responsiveness to treatment, reproducibility, and minimal clinically important difference of the Patient Health Questionnaire-9 (PHQ-9), a standard instrument for diagnosing depression in primary care. This study included 434 intervention subjects from the IMPACT study, a multisite treatment trial of late-life depression (63% female, mean age 71 years). Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period. Test-retest reliability and minimal clinically important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart. The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months (-1.3 versus -0.9) and equivalent at 6 months (-1.3 versus -1.2). With respect to structured diagnostic interviews, both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression, partial remission, and full remission. Test-retest reliability of the PHQ-9 was excellent, and its minimal clinically important difference for individual change, estimated as 2 standard errors of measurement, was 5 points on the 0 to 27 point PHQ-9 scale. Well-validated as a diagnostic measure, the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes. Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research.
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            Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population.

            The aim of this study was to assess the validity of the Patient Health Questionnaire depression module (PHQ-9). It has been subject to studies in medical settings, but its validity as a screening for depression in the general population is unknown. A representative population sample (2,066 subjects, 14-93 years) filled in the PHQ-9 for diagnosis [major depressive disorder, other depressive disorder, depression screen-positive (DS+) and depression screen-negative (DS-)] and other measures for distress (GHQ-12), depression (Brief-BDI) and subjective health perception (EuroQOL; SF-36). A prevalence rate of 9.2% of a current PHQ depressive disorder (major depression 3.8%, subthreshold other depressive disorder 5.4%) was identified. The two depression groups had higher Brief-BDI and GHQ-12 scores, and reported lower health status (EuroQOL) and health-related quality of life (SF-36) than did the DS- group (P's < .001). Strong associations between PHQ-9 depression severity and convergent variables were found (with BDI r = .73, with GHQ-12 r = .59). The results support the construct validity of the PHQ depression scale, which seems to be a useful tool to recognize not only major depression but also subthreshold depressive disorder in the general population.
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              The World Mental Health (WMH) Survey Initiative Version of the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI).

              This paper presents an overview of the World Mental Health (WMH) Survey Initiative version of the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI) and a discussion of the methodological research on which the development of the instrument was based. The WMH-CIDI includes a screening module and 40 sections that focus on diagnoses (22 sections), functioning (four sections), treatment (two sections), risk factors (four sections), socio-demographic correlates (seven sections), and methodological factors (two sections). Innovations compared to earlier versions of the CIDI include expansion of the diagnostic sections, a focus on 12-month as well as lifetime disorders in the same interview, detailed assessment of clinical severity, and inclusion of information on treatment, risk factors, and consequences. A computer-assisted version of the interview is available along with a direct data entry software system that can be used to keypunch responses to the paper-and-pencil version of the interview. Computer programs that generate diagnoses are also available based on both ICD-10 and DSM-IV criteria. Elaborate CD-ROM-based training materials are available to teach interviewers how to administer the interview as well as to teach supervisors how to monitor the quality of data collection.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                March 2020
                13 March 2020
                : 9
                : 3
                : e15540
                [1 ] University of Tasmania Hobart Australia
                [2 ] Monash University Melbourne Australia
                Author notes
                Corresponding Author: Jacqui McCoy jsmccoy@ 123456utas.edu.au
                Author information
                ©Jacqui McCoy, Suzanne Nielsen, Raimondo Bruno. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.03.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 18 July 2019
                : 3 October 2019
                : 17 October 2019
                : 20 October 2019

                codeine,opioids,dependence,rescheduling,drug policy
                codeine, opioids, dependence, rescheduling, drug policy


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