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STUDY PROTOCOL

Cohort Description: Preventing an Opioid Epidemic in Norway – Focusing on Treatment of Chronic Pain (POINT) – A National Registry-Based Study

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Pages 1477-1486 | Received 25 Jul 2022, Accepted 25 Oct 2022, Published online: 08 Dec 2022
 

Abstract

Aim

The POINT project aims to provide evidence to optimise chronic pain management, prevent adverse consequences of opioids, and improve chronic pain patients’ pain relief, functional capacity, and quality of life. We describe the outline of the project and its work packages. More specifically, we describe a cohort of persons with chronic pain and a cohort of long-term opioid users identified from a national registry linkage.

Data Sources

The project utilises data from nationwide healthcare and population registers in Norway. Using the Norwegian Prescription Database, we identified a cohort of persons who have been dispensed drugs reimbursed for chronic pain and a cohort of persons who used opioids long term from 2010 to 2019. Data from the Norwegian Registry for Primary Health Care and the Norwegian Patient Registry (2008–2019), Cancer Registry (1990–2018) Cause of Death Registry (2010–2019) and demographic and socioeconomic registers from Statistics Norway (2010–2019) were linked to the cohorts.

Study Population

There were 568,869 participants with chronic pain. Sixty-three percent of the cohort was women, and the mean age was 57.1 years. There were 336,712 long-term opioid users (58.6% women; 60.9 years). In chronic pain and long-term opioid user cohorts, the most frequent musculoskeletal diagnosis was back pain diagnosed in primary care (27.6% and 30.7%). Psychiatric diagnoses were also common.

Main Variables

Upcoming studies will utilise psychiatric and somatic diagnoses from the patient registers, drug use from the prescription register, causes of death, demographics, and socioeconomic status (eg, education, income, workability, immigrant status) as exposures or outcomes.

Conclusion and Future Plans

The two cohorts have numerous pain-related diagnoses, especially in the musculoskeletal system, and noticeably frequent somatic and psychiatric morbidity. The POINT project also includes later work packages that explore prescriber and patient perspectives around safe and effective treatment of chronic pain.

Disclaimer

Data from the Norwegian Patient Registry and the Cancer Registry of Norway have been used in this publication. The interpretation and reporting of these data are the sole responsibility of the authors, and no endorsement by the Norwegian Patient Registry or the Cancer Registry of Norway is intended nor should be inferred.

Data Sharing Statement

The register-based cohorts are based on individual-level data from the national health and population registers. The authors are not allowed, by law, to publicly share this data. Therefore, the authors cannot make these data fully available to the public. The authors may share statistical code.

Ethics

The Norwegian Institute of Public Health has completed and approved a Data Protection Impact Assessment for the register-based studies in work packages 1 and 2, in accordance with the General Data Protection Regulation (GDPR). The Regional Committee for Medical and Health Research Ethics (REC South-East) has also approved the studies in work packages 1 and 2 (2019/656/REC South-East C). The data for work packages 1 and 2 have been pseudonymised and stored at Services for Sensitive data (TSD) at the University of Oslo, dedicated explicitly to storing sensitive research data. Only selected members of the research group will have access to the data. All disseminations from the studies will be aggregated; thus, no individual participants will be identifiable. In the qualitative studies, participants will be pseudonymised, and effort will be taken to protect their anonymity in publications. We expect to apply for ethical approval for the studies in work packages 3 and 4 in 2022–2023.

Acknowledgments

The POINT project is a collaboration between partners from the research sector (University of Oslo (SERAF), The Norwegian Institute of Public Health, and the Center for Alcohol and Drug Research (KORFOR)), partners from outside the research sector (Stavanger Municipality, Stavanger University Hospital, St. Olavs Hospital, and Trondheim University Hospital), and two user organisations (Norwegian Chronic Pain Patients’ Organization (FKS) and Norwegian Forum of Disabled Peoples’ Organizations (SAFO)). The authors acknowledge all of the other members of the POINT study group: Ann Oldervoll (Norwegian Centre for Addiction Research (SERAF), University of Oslo), Christian Tjagvad (Norwegian Centre for Addiction Research (SERAF), University of Oslo), Håvar Brendryen (Department of Psychology, University of Oslo), Ashley Muller (Norwegian Institute of Public Health), Dagfinn Glad (Norwegian Forum of Disabled Peoples’ Organizations (SAFO)), Eva Skovlund (Norwegian University of Science and Technology), Håkon Nestvold (Norwegian Centre for Addiction Research (SERAF), University of Oslo), Jørgen Møllerop (Stavanger Municipality), Jorunn Arnesen (Norwegian Chronic Pain Patients’ Organization (FKS)), Line Cecilie Christiansen (Stavanger Municipality), Line Cecilie Gjerde (Norwegian Institute of Public Health), Linn Gjersing (Norwegian Institute of Public Health), Olav Fredheim (Norwegian University of Science and Technology, St. Olavs Hospital/Trondheim University Hospital, Akershus University Hospital), Olof A Steingrimsdottir (Norwegian Institute of Public Health), Ottar Ness (Norwegian University of Science and Technology), Stine Sveingård (Norwegian University of Science and Technology), and Svein Skeie (Helse Stavanger HF). The authors further thank Ann Oldervoll for editing the language of the manuscript.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

GK has received grants from Novo Nordisk Foundation, The Danish Cancer Society, and European Commission, Horizon Europe Framework Programme (HORIZON). SH has received lecture fees from Eisai Ltd. Dr Vidar Hjellvik reports grants from Norwegian Research Council, during the conduct of the study. The authors report no other conflicts of interest in this work.

Additional information

Funding

The POINT project is supported by the Norwegian Research Council (grant no. 320360).