Description of the Oslo University Hospital Pain Registry (OPR)

Oslo Pain Registry (OPR) is a local quality registry established on October 1, 2015. The registry is affiliated with the Department of Pain Management and Research at Oslo University Hospital (OUH), which is the largest interdisciplinary outpatient pain clinic in Norway. Patients are referred from primary and secondary health care services across all health regions in Norway. The registry is evolving, and received a major overhaul in 2020, switching technical platform, and gathering more detailed information about diagnosis and data from the clinicians, called OPR version 2.

Objective

The objective of the registry is to promote and provide a basis for continuous quality improvement at the clinic, and to perform research on patient characteristics and various treatment methods for patients with chronic pain conditions seeking treatment in specialist health services.

Data collection

Data collection in OPR occurs in a naturalistic clinical setting. It involves:

Questionnaires: Prior to their first consultation, patients are required to complete a comprehensive set of self-reported questionnaires electronically. These questionnaires capture basic demographic information, pain characteristics, and an array of outcomes related to pain such as quality of life (QOL), disability, distress, and mood. Questionnaires are also distributed to patients 12 months after completed treatment, every 12 months for patients being in treatment more than 1 year. Specific projects can also collect data within other time frames.

Data provided by clinicians: Data regarding diagnostics and treatment is registered by healthcare providers for each visit.

The use of Data

The OPR Steering Committee grants approval after a standardized application process. To access data from the registry, the applicant must submit a project protocol. The use of data must adhere to the registry's statutes, and a responsible person for the use of the data must be clearly identified. The steering committee judge several factors, including the academic quality and originality of the project, and its utility for healthcare research. The academic environment surrounding the applicant is also considered. It's crucial that new projects do not conflict with ongoing projects. If necessary, approval from the Ethics Committee and/or the relevant data protection officer must be obtained in accordance with national regulations.

Ethics and Regulations

The registry received approval from the OUH Data Protection Officer in 2014 in accordance with the applicable regulations at that time (2014/1309). The Norwegian Health Research Act, as referenced in §§ 2 and § 4, does not regulate the use of anonymous data as defined by the GDPR. This has been affirmed by the Regional Committee of Medical and Health Related Research (Mid Norway) and this confirmation can be made available upon request. Studies utilizing anonymous data do not require prior approval from the Committee of Medical and Health Related Research, provided that the dataset was generated legally. Therefore, the registry's steering committee evaluates projects seeking data access, and upon approval, can provide anonymous data to applicants.

OPR v1 (2015 – 2020) obtained consent from patients to participate in the registry.

OPR v2 (2020 – up to date) has been granted that all patients are enrolled in the registry by default but can exert their right to reserve from participation. In accordance with Norwegian legislation (Regulation for medical quality registries (Forskrift om medisinske kvalitetsregistre) § 3-2), OPR does not require explicit consent from participants. This approach is based on the assessment that condition § 3-2.a is applicable, indicating that obtaining consent would impact the representativeness of patient data, thereby affecting the registry's objectives. This determination has been reviewed and approved by the hospital's Data Protection Officer. Participants are informed of their inclusion and retain the right to opt-out, ensuring respect for individual autonomy while maintaining compliance with privacy regulations.

About the Clinical Care Team and Treatment Modalities

The interdisciplinary clinical team consists of physicians), psychologists, physiotherapists, and nurses.

The clinic provides a wide spectrum of treatment modalities, including but not limited to:

Pharmacological interventions, invasive pain treatments, physical therapy, psychological treatment modalities.