Opioid maintenance treatment in the Czech Republic, Norway and Denmark: a study protocol of a comparative registry linkage study
Jazyk angličtina Země Anglie, Velká Británie Médium electronic
Typ dokumentu časopisecké články, práce podpořená grantem
PubMed
33972343
PubMed Central
PMC8112418
DOI
10.1136/bmjopen-2020-047028
PII: bmjopen-2020-047028
Knihovny.cz E-zdroje
- Klíčová slova
- health & safety, public health, substance misuse,
- MeSH
- lidé MeSH
- opiátová substituční terapie * MeSH
- poruchy spojené s užíváním opiátů * farmakoterapie epidemiologie MeSH
- registrace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
- Dánsko epidemiologie MeSH
- Norsko epidemiologie MeSH
INTRODUCTION: Opioid maintenance treatment (OMT) varies across settings and between countries. We plan to use data from several nationwide health and population registers to further improve the knowledge base established from earlier studies. Our aim is to study OMT adherence trajectories and to identify factors associated with improved outcomes for OMT patients across the Czech Republic, Norway and Denmark, in order to further improve OMT and our understanding of the key elements of treatment success. METHODS AND ANALYSIS: The registry-based cohort approach across the three countries allows us to link data from a range of registers on the individual level, by using personal identifiers in nationwide cohorts of OMT and non-OMT patients and the general non-using populations. A total of ~21 500 OMT patients over the last two decades in all three countries will be included in the study. The following outcome variables (based on the International Classification of Diseases, 10th Revision codes) will be obtained from relevant registers: treatment adherence to OMT, comorbidity (somatic and mental health), and all-cause and cause-specific mortality. Outcomes of the country-specific analyses will be pooled. ETHICS AND DISSEMINATION: The national OMT cohorts have been approved by the ethics committees in the respective countries. Data will be stored according to national and local guidelines and treated confidentially, and all data will be analysed separately for each country and compared across countries. Findings will be disseminated in peer-reviewed scientific journals, national and international conferences, and in briefings to inform clinical decision-making.
Centre For Alcohol And Drug Research Aarhus University Aarhus Denmark
Department of Addictology 1st Faculty of Medicine Charles University Prague Czech Republic
Department of Addictology General University Hospital Prague Prague Czech Republic
Norwegian Centre for Addiction Research University of Oslo Oslo Norway
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Degenhardt L, Grebely J, Stone J, et al. . Global patterns of opioid use and dependence: harms to populations, interventions, and future action. Lancet 2019;394:1560–79. 10.1016/S0140-6736(19)32229-9 PubMed DOI PMC
James SL, Abate D, Abate KH, et al. . Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet 2018;392:1789–858. 10.1016/S0140-6736(18)32279-7 PubMed DOI PMC
Vereinte Nationen . Büro für Drogenkontrolle und Verbrechensbekämpfung. World drug report 2018, 2018.
Zibbell JE, Asher AK, Patel RC, et al. . Increases in acute hepatitis C virus infection related to a growing opioid epidemic and associated injection drug use, United States, 2004 to 2014. Am J Public Health 2018;108:175–81. 10.2105/AJPH.2017.304132 PubMed DOI PMC
Skeie I, Brekke M, Lindbaek M, et al. . Somatic health among heroin addicts before and during opioid maintenance treatment: a retrospective cohort study. BMC Public Health 2008;8:43. 10.1186/1471-2458-8-43 PubMed DOI PMC
Higgins C, Smith BH, Matthews K. Comparison of psychiatric comorbidity in treatment‐seeking, opioid‐dependent patients with versus without chronic pain. Addiction 2020;115:249–58. 10.1111/add.14768 PubMed DOI
Bukten A, Skurtveit S, Gossop M, et al. . Engagement with opioid maintenance treatment and reductions in crime: a longitudinal national cohort study: opioid maintenance treatment and crime. Addiction 2012;107:393–9. 10.1111/j.1360-0443.2011.03637.x PubMed DOI
Skjaervø I, Skurtveit S, Clausen T, et al. . Substance use pattern, self-control and social network are associated with crime in a substance-using population. Drug Alcohol Rev 2017;36:245–52. 10.1111/dar.12406 PubMed DOI
Nutt DJ, King LA, Phillips LD, et al. . Drug harms in the UK: a multicriteria decision analysis. Lancet 2010;376:1558–65. 10.1016/S0140-6736(10)61462-6 PubMed DOI
Taylor M, Mackay K, Murphy J, et al. . Quantifying the RR of harm to self and others from substance misuse: results from a survey of clinical experts across Scotland. BMJ Open 2012;2:e000774. 10.1136/bmjopen-2011-000774 PubMed DOI PMC
van Amsterdam J, Opperhuizen A, Koeter M, et al. . Ranking the harm of alcohol, tobacco and illicit drugs for the individual and the population. Eur Addict Res 2010;16:202–7. 10.1159/000317249 PubMed DOI
Degenhardt L, Bucello C, Mathers B, et al. . Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction 2011;106:32–51. 10.1111/j.1360-0443.2010.03140.x PubMed DOI
Degenhardt L, Larney S, Randall D. Causes of death in a cohort treated for opioid dependence between 1985 and 2005: mortality among opioid-dependent people. Addiction 2014;109:90–9. 10.1111/add.12337 PubMed DOI
World Health Organization . International narcotics control board, United nations office on drugs and crime, editors. guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. Geneva: World Health Organization, 2009: 111. PubMed
European Monitoring Centre for Drugs and Drug Addiction . Health and social responses to drug problems: a European guide. [online]. LU: Publications Office, 2017. https://data.europa.eu/doi/
European Monitoring Centre for Drugs and Drug Addiction . European drug report 2019: trends and developments [online], 2019. Available: https://data.europa.eu/doi/ [Accessed 17 Aug 2019].
Skurtveit S, Nechanská B, Handal M, et al. . Hospitalization of children after prenatal exposure to opioid maintenance therapy during pregnancy: a national registry study from the Czech Republic. Addiction 2019;114:1225-1235 https://onlinelibrary.wiley.com/doi/abs/ 10.1111/add.14576 PubMed DOI PMC
Nechanská B, Mravcík V, Skurtveit S, et al. . Neonatal outcomes after fetal exposure to methadone and buprenorphine: national registry studies from the Czech Republic and Norway. Addiction 2018;113:1286–94. 10.1111/add.14192 PubMed DOI PMC
Jones HE, Kaltenbach K, Heil SH, et al. . Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med 2010;363:2320–31. 10.1056/NEJMoa1005359 PubMed DOI PMC
Bukten A, Stavseth MR, Clasuen T. From restrictive to more liberal: variations in mortality among patients in opioid maintenance treatment over a 12-year period. BMC Health Serv Res 2019;19 https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-019-4382-9 PubMed DOI PMC
Clausen T, Anchersen K, Waal H. Mortality prior to, during and after opioid maintenance treatment (OMT): a national prospective cross-registry study. Drug Alcohol Depend 2008;94:151–7. 10.1016/j.drugalcdep.2007.11.003 PubMed DOI
Connock M, Juarez-Garcia A, Jowett S, et al. . Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. Health Technol Assess 2007;11 https://www.journalslibrary.nihr.ac.uk/hta/hta11090/10.3310/hta11090 PubMed DOI
Degenhardt L, Randall D, Hall W, et al. . Mortality among clients of a state-wide opioid pharmacotherapy program over 20 years: risk factors and lives saved. Drug Alcohol Depend 2009;105:9–15. 10.1016/j.drugalcdep.2009.05.021 PubMed DOI
Marotta PL, McCullagh CA. A cross-national analysis of the association between years of implementation of opioid substitution treatments and drug-related deaths in Europe from 1995 to 2013. Eur J Epidemiol 2018;33:679–88. 10.1007/s10654-017-0342-z PubMed DOI PMC
Sordo L, Barrio G, Bravo MJ, et al. . Mortality risk during and after opioid substitution treatment: systematic review and meta-analysis of cohort studies. BMJ 2017;357:j1550. 10.1136/bmj.j1550 PubMed DOI PMC
Maglione MA, Raaen L, Chen C, et al. . Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: a systematic review. J Subst Abuse Treat 2018;89:28–51. 10.1016/j.jsat.2018.03.001 PubMed DOI
Bukten A, Skurtveit S, Waal H, et al. . Factors associated with dropout among patients in opioid maintenance treatment (OMT) and predictors of re-entry. A national registry-based study. Addict Behav 2014;39:1504–9. 10.1016/j.addbeh.2014.05.007 PubMed DOI
Busch M, Klein C, Uhl A, et al. . Retention in the Austrian opioid agonist treatment system: a national prospective cohort study. Harm Reduct J 2021;18:25. 10.1186/s12954-021-00473-9 PubMed DOI PMC
Nordt C, Wiessing L, Kuijpers W, et al. . Long-term opioid agonist treatment participation after first treatment entry is similar across 4 European regions but lower in Non-Nationals. Eur Addict Res 2018;24:173–83. 10.1159/000490529 PubMed DOI
Gabrhelík R, Nechanská B, Mravcík V, et al. . A unique opportunity to study short- and long-term consequences in children prenatally exposed to illicit drugs and opioid maintenance treatment using Czech and Scandinavian registers. Cent Eur J Public Health 2016;24:248–51. 10.21101/cejph.a4474 PubMed DOI
McMahon AW, Dal Pan G. Assessing drug safety in children — the role of real-world data. N Engl J Med 2018;378:2155–7. 10.1056/NEJMp1802197 PubMed DOI PMC
Mahic M, Hernandez-Diaz S, Wood M, et al. . In utero opioid exposure and risk of infections in childhood: a multinational Nordic cohort study. Pharmacoepidemiol Drug Saf 2020;29:1596–604. 10.1002/pds.5088 PubMed DOI
Mravcik V, Orlíková B. Substituční Léčba Závislosti Na Opioidech V ČR: Kritický Pohled. Čes a slov Psychiat 2019;115:53–8.
Mravcík V, Janíková B, Drbohlavová B, et al. . The complex relation between access to opioid agonist therapy and diversion of opioid medications: a case example of large-scale misuse of buprenorphine in the Czech Republic. Harm Reduct J 2018;15:60. 10.1186/s12954-018-0268-0 PubMed DOI PMC
Waal H. Merits and problems in high-threshold methadone maintenance treatment. Eur Addict Res 2007;13:66–73. 10.1159/000097935 PubMed DOI
European Monitoring Centre for Drugs and Drug Addiction . European drug report 2020: trends and developments [online]. LU: Publications Office, 2020. https://data.europa.eu/doi/10.2810/420678
European Monitoring Centre for Drugs and Drug Addiction . Denmark country overview, 2016. Available: https://www.emcdda.europa.eu/node/2580_ro#treatmentResponses [Accessed 20 Oct 2020].
Sundhedsstyrelsen . Evaluering AF ordning Med lægeordineret heroin TIL stofmisbrugere 2010-2012 2013.
Skretting A, Rosenqvist P. Shifting focus in substitution treatment in the Nordic countries. Nord Stud Alcohol Drugs 2010;27:581–98. 10.1177/145507251002700604 DOI
Sundhedsstyrelsen . Vejledning TIL læger, Der behandler opioidafhængige patienter Med substitutionsmedicin: lovkrav OG anbefalinger. Sundhedsstyrelsen 2017.
Furu K, Karlstad Øystein, Skurtveit S, et al. . High validity of mother-reported use of antiasthmatics among children: a comparison with a population-based prescription database. J Clin Epidemiol 2011;64:878–84. 10.1016/j.jclinepi.2010.10.014 PubMed DOI PMC
Furu K, Wettermark Björn, Andersen M, et al. . The Nordic countries as a cohort for Pharmacoepidemiological research. Basic Clin Pharmacol Toxicol 2010;106:86–94. 10.1111/j.1742-7843.2009.00494.x PubMed DOI
Hallas J. Conducting pharmacoepidemiologic research in Denmark. Pharmacoepidemiol Drug Saf 2001;10:619. 10.1002/pds.638 PubMed DOI
Schmidt M, Pedersen L, Sørensen HT. The Danish civil registration system as a tool in epidemiology. Eur J Epidemiol 2014;29:541–9. 10.1007/s10654-014-9930-3 PubMed DOI
Schmidt M, Schmidt SAJ, Sandegaard JL, et al. . The Danish national patient registry: a review of content, data quality, and research potential. Clin Epidemiol 2015;7:449. 10.2147/CLEP.S91125 PubMed DOI PMC
Pedersen AG, Ellingsen CL. Datakvaliteten i Dødsårsaksregisteret. Tidsskriftet 2015;135:768–70. 10.4045/tidsskr.14.1065 PubMed DOI
Sundhedsstyrelsen . Stofmisbrugsbehandling – efterspørgsel og tilgængelighed. Narkotikasituationen i Danmark - delrapport 3 [online]. Sundhedsstyrelsen, 2020. https://www.sst.dk/-/media/Udgivelser/2020/Narkotikasituationen/Narkorapporten-03.ashx?la=da&hash=1E075F4218C3B4CA2E3B38A28D9B56B6D2BB428C
Borschmann R, Tibble H, Spittal MJ, et al. . The mortality after release from incarceration Consortium (MARIC): protocol for a multi-national, individual participant data meta-analysis. Int J Popul Data Sci 2020;5:1145. 10.23889/ijpds.v5i1.1145 PubMed DOI PMC
Kivimäki M, Nyberg ST, Batty GD, et al. . Job strain as a risk factor for coronary heart disease: a collaborative meta-analysis of individual participant data. Lancet 2012;380:1491–7. 10.1016/S0140-6736(12)60994-5 PubMed DOI PMC
Riley RD, Lambert PC, Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ 2010;340:c221. 10.1136/bmj.c221 PubMed DOI
Rothman KJ, Greenland S, Lash TL. Modern epidemiology. 3rd edn. Philadelphia, Baltimore, New York: Wolters Kluwer Health, Lippincott Williams & Wilkins, 2008: 758.
von Elm E, Altman DG, Egger M, et al. . The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Int J Surg 2014;12:1495–9. 10.1016/j.ijsu.2014.07.013 PubMed DOI
Tjagvad C, Skurtveit S, Linnet K, et al. . Methadone-related overdose deaths in a liberal opioid maintenance treatment programme. Eur Addict Res 2016;22:249–58. 10.1159/000446429 PubMed DOI
Mravcík V, Nechanská B, Gabrhelík R, et al. . Socioeconomic characteristics of women with substance use disorder during pregnancy and neonatal outcomes in their newborns: a national registry study from the Czech Republic. Drug Alcohol Depend 2020;209:107933. 10.1016/j.drugalcdep.2020.107933 PubMed DOI
Kivimies K, Repo-Tiihonen E, Kautiainen H, et al. . Comorbid opioid use is undertreated among forensic patients with schizophrenia. Subst Abuse Treat Prev Policy 2018;13:39. 10.1186/s13011-018-0177-y PubMed DOI PMC