Opportunities and challenges for real-world studies on chronic inflammatory joint diseases through data enrichment and collaboration between national registers: the Nordic example

Abstract

There are increasing needs for detailed real-world data on rheumatic diseases and their treatments. Clinical register data are essential sources of information that can be enriched through linkage to additional data sources such as national health data registers. Detailed analyses call for international collaborative observational research to increase the number of patients and the statistical power. Such linkages and collaborations come with legal, logistic and methodological challenges. In collaboration between registers of inflammatory arthritides in Sweden, Denmark, Norway, Finland and Iceland, we plan to enrich, harmonise and standardise individual data repositories to investigate analytical approaches to multisource data, to assess the viability of different logistical approaches to data protection and sharing and to perform collaborative studies on treatment effectiveness, safety and health-economic outcomes. This narrative review summarises the needs and potentials and the challenges that remain to be overcome in order to enable large-scale international collaborative research based on clinical and other types of data.

Short-term, intermediate-term and long-term risks of acute coronary syndrome in cohorts of patients with RA starting biologic DMARDs: results from four Nordic countries

“…We performed an observational cohort study using prospectively collected individual-level data from the clinical rheumatology registers in Denmark (DANBIO), Finland (ROB-FIN), Norway (NOR-DMARD) and Sweden (SRQ-ARTIS) 27–31. In each country, linkages of the clinical data to other national registers were performed in order to identify data on past and incident ACS events, covariates (see definitions below), emigration and vital status throughout the study period from 1 January 2008 (1 January 2009 for Norway) to 31 December 2017 30…”

“…In each cohort, ACS during follow-up was defined as the first registered event of hospitalisation due to either unstable angina (International Classification of Diseases 10th Revision (ICD-10) I20.0) or acute myocardial infarction (MI) (transmural MI ICD-10 I21.0, I21.1, I21.2, I21.3; subendocardial MI ICD-10 I21.4; unspecific MI I21.9), as identified via linkage to the national patient registers 30. In Sweden, the definition also included deaths stating ICD-10 I21 or I20.0 as main cause.…”

“…Using the registers’ linkage,30 we identified baseline (ie, at treatment start) covariates for each treatment cohort: demographics (eg, sex), clinical (eg, C reactive protein (CRP)), comedication (eg, methotrexate), comorbidities (eg, history of a thromboembolic event) and related medications (eg, use of anticoagulants) and other information (eg, number of previous hospitalisations), see online supplemental table 1.…”

One‐Year Treatment Outcomes of Secukinumab Versus Tumor Necrosis Factor Inhibitors in Spondyloarthritis: Results From Five Nordic Biologic Registries Including More Than 10,000 Treatment Courses

“…We have previously described a Nordic epidemiologic research collaboration in inflammatory arthritis aiming to investigate rare exposures or outcomes based on combined data sets from 5 prospective biologic registries enriched with data from national registries (15)(16)(17). Within this collaboration, we aimed to explore the following in SpA patients treated with secukinumab versus TNFi (mainly adalimumab) and followed in routine care in the Nordic countries: 1) patient characteristics at treatment start; 2) retention to treatment during the first year, including reasons for withdrawal; and 3) 6-month treatment responses.…”

EULAR recommendations for a core data set for pregnancy registries in rheumatology

“…As highlighted by other initiatives in rheumatology, harmonising and standardising items and their measurement across studies is critical to facilitate collaborative research. [3][4][5][6] A EULAR Task Force was therefore convened to define a core data set for registries and observational studies that prospectively collect information about pregnant women with IRD including the neonatal phase (four weeks post partum). The core set was developed to encompass a minimum of standardised items to be collected paving the way for multinational collaborations.…”