Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial.

Objective: This protocol paper describes the rationale and design of a randomised controlled trial (RCT) that aims to evaluate the (cost-)effectiveness of a 12 week e-self-management intervention (Happy Hands app) in people with hand osteoarthritis (HOA).

Methods: In this multicentre RCT, 376 people with HOA will be recruited from all four health regions in Norway. Consenting participants will be randomly allocated to either a control group receiving usual care or an intervention group receiving the Happy Hands app in addition to usual care.

Protocol for the MERINO study: A randomized placebo-controlled trial assessing the efficacy, safety, and cost-effectiveness of methotrexate in people with erosive hand osteoarthritis.

Objective: Previous studies on the efficacy of methotrexate in people with hand osteoarthritis (OA) have shown conflicting results. The MERINO trial aims to investigate the efficacy and safety of methotrexate in people with painful inflammatory erosive hand OA.

Design: In total 163 participants with erosive hand OA, synovitis by ultrasound, and finger joint pain of 40-80 ​mm on a visual analogue scale (VAS) will be recruited from a rheumatology outpatient clinic.

Efficacy and safety of non-pharmacological, pharmacological and surgical treatments for hand osteoarthritis in 2024: a systematic review.

Background: We aimed to update the 2018 systematic literature review on the efficacy and safety of treatments for hand osteoarthritis (OA), which was based on 126 studies.

Methods: We performed a systematic literature search on randomised controlled trials from June 2017 up to 31 December 2023. Risk of bias was assessed using the RoB2 tool.

Systematic literature review and meta-analysis informing the EULAR points to consider on the initiation of targeted therapies in patients with inflammatory arthritis and a history of cancer.

Background: Targeted therapies have been associated with potential risk of malignancy, which is a common concern in daily rheumatology practice in patients with inflammatory arthritis (IA) and a history of cancer.

Objectives: To perform a systematic literature review to inform a Task Force formulating EULAR points to consider on the initiation of targeted therapies in patients with IA and a history of cancer.

Methods: Specific research questions were defined within the Task Force before formulating the exact research queries with a librarian.

2024 EULAR points to consider on the initiation of targeted therapies in patients with inflammatory arthritis and a history of cancer.

Background: Potential associations between targeted therapies and a new cancer in patients with inflammatory arthritis (IA) and a previous malignancy are a frequent concern in daily rheumatology practice.

Objectives: To develop points to consider (PTC) to assist rheumatologists when initiating a targeted therapy in the context of a previous malignancy.

Methods: Following EULAR standardised operating procedures, a task force met to define the research questions for a systematic literature review and to formulate the overarching principles (OPs) and the PTC.

Completeness of repeated patient-reported outcome measures in adult rehabilitation: a randomized controlled trial in a diverse clinical population.

Background: Data collection through patient-reported outcome measures (PROMs) is essential for the purpose of rehabilitation research and registries. Existing problems with incomplete PROM data may relate to the patient burden and data set length. This study aimed to analyse response patterns and degree of data completeness in systematic outcome assessments conducted within a clinical study in a multidisciplinary rehabilitation setting, comparing completeness of a brief and a longer set of PROMs.

Pain sensitization in fibromyalgia. Cross-sectional associations between quantitative sensory testing of pain sensitization and fibromyalgia disease burden.

Background: Whether fibromyalgia burden is related to measures of sensitization, assessed by quantitative sensory testing (QST), is not clear. We examine the associations between sensitization and fibromyalgia disease burden as measured by the polysymptomatic sistress scale (PDS) and the fibromyalgia impact questionnaire (FIQ) (range 0-100).

Materials And Methods: Participants were recruited from referrals to a rheumatology outpatient clinic and the fibromyalgia diagnosis was verified by a rheumatologist.

Study protocol for the PICASSO trial: A randomized placebo-controlled trial to investigate the efficacy and safety of intraarticular steroid injections and an occupational therapy intervention in painful inflammatory carpometacarpal-1 osteoarthritis.

Objective: Our primary objectives are to assess whether intraarticular corticosteroid injections are superior to saline injections with regards to thumb base pain after 4 weeks, and to compare the efficacy of steroid injections, saline injections, and an occupational therapy intervention on thumb base pain after 12 weeks in people with painful inflammatory osteoarthritis (OA) of the first carpometacarpal (CMC-1) joint.

Design: In this three-armed, double-blind, randomized multicenter trial, 354 participants with painful inflammatory CMC-1 OA from six Norwegian hospitals are recruited. Participants are randomized 1:1:1 to intraarticular steroid or saline injections in the CMC-1 joint or a multimodal occupational therapy intervention.

Legal obstacles jeopardise research in personalised medicine - experiences from a Nordic collaboration within rheumatology.

Aims: Personalised medicine in chronic complex diseases such as rheumatoid arthritis (RA) is within reach but requires international multi-stakeholder collaboration. We exemplify how national implementations of the General Data Protection Regulation (GDPR) have introduced administrative delays and created disincentives for data sharing and collaborative research.

Methods: Our Danish/Swedish/Norwegian research collaboration (the 3-year NordForsk-funded "NORA" project) aims to develop a personalised medicine approach for the management of RA, built on the exploitation of unique existing data sources: longitudinal data from clinical rheumatology registries, research cohorts, nationwide health care registries, and biobank material from >20 sample collections.

Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: a replication study.

Background: Musculoskeletal disorders are an extensive burden to society, yet few studies have explored and replicated modifiable prognostic factors associated with high societal costs. This study aimed to replicate previously identified associations between nine modifiable prognostic factors and high societal costs among people on sick leave due to musculoskeletal disorders.

Methods: Pooled data from a three-arm randomised controlled trial with 6 months of follow-up were used, including 509 participants on sick leave due to musculoskeletal disorders in Norway.

Humoral and cellular responses to a fifth bivalent SARS-CoV-2 vaccine dose in patients with immune-mediated inflammatory diseases on tumour necrosis factor inhibitors: a prospective cohort study.

Background: As most people now have established hybrid immunity, the need for regular, updated SARS-CoV-2 vaccine boosters in patients with immune-mediated inflammatory diseases (IMIDs) is unclear. The study aim was to assess humoral and cellular immunogenicity of a fifth bivalent vaccine dose in patients with IMID on tumour necrosis factor inhibitors (TNFi).

Methods: In the longitudinal, observational Nor-vaC study, we assessed anti-spike and neutralising antibodies against Wuhan, Omicron BA.

Performance of the EULAR Systemic sclerosis Impact of Disease (ScleroID) questionnaire as a patient-reported outcome measure for patients with diffuse systemic sclerosis.

Objective: Systemic sclerosis Impact of Disease (ScleroID) is the first comprehensive patient-reported outcome measure (PROM) specifically developed for systemic sclerosis (SSc). We investigated the performance of ScleroID in patients with diffuse cutaneous SSc (dcSSc), as a prerequisite for its use in randomised controlled trials (RCTs) testing potentially disease-modifying drugs.

Methods: All patients with dcSSc from the large, multicentric, ScleroID cohort were included.

Proactive therapeutic drug monitoring of biologic drugs in patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis: systematic review and meta-analysis.

Objective: To address the efficacy and safety of proactive therapeutic drug monitoring of biologic drugs for patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis.

Design: Systematic review and meta-analysis.

Data Sources: Medline, Embase, Central, and CINAHL, from database inception to 23 May 2024.

Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial.

Objectives: The objectives of this study are to identify a therapeutic serum level for adalimumab associated with remission and low disease activity in patients with rheumatoid arthritis.

Methods: Associations between serum adalimumab trough levels and disease activity were examined using longitudinal data from a 48-week randomised phase III trial including patients with tumour necrosis factor inhibitor-naïve rheumatoid arthritis with active disease starting adalimumab treatment. Disease activity was classified according to 28-joint Disease Activity Score (DAS28)-erythrocyte sedimentation rate and C reactive protein (CRP) levels.

Longitudinal stability of molecular endotypes of knee osteoarthritis patients.

Objective: To assess the longitudinal stability of biomarker-based molecular endotypes of knee osteoarthritis (KOA) participants from APPROACH and to evaluate the consistency of findings in an independent KOA population.

Methods: Nineteen biomarkers were measured longitudinally in 295 KOA participants from the APPROACH cohort. K-means clustering was used to identify the structural damage, inflammation, and low tissue turnover endotypes at the six-, 12-, and 24-month follow-ups.

Multi-centre modified Delphi exercise to identify candidate items for classifying early-stage symptomatic knee osteoarthritis.

Objective: To generate a list of candidate items potentially useful for discriminating individuals with Early-stage Symptomatic Knee Osteoarthritis (EsSKOA) from those with other conditions and from established osteoarthritis (OA), and to reduce this list based on expert consensus.

Design: We conducted a three-round online international modified Delphi exercise with OA clinicians and researchers ("OA experts"). In Round 1, participants reviewed 84 candidate items and nominated additional item(s) potentially useful for EsSKOA classification; those nominated by ≥3 participants were added.

Impact of patient characteristics on ASDAS disease activity state cut-offs in axial spondyloarthritis: results from nine European rheumatology registries.

Objectives: To re-evaluate cut-offs for disease activity states according to the Axial Spondyloarthritis Disease Activity Score (ASDAS), and study the impact of sex, age, calendar time, disease and symptom duration on ASDAS and ASDAS cut-offs in a large contemporary cohort.

Methods: Data from 2939 patients with axial spondyloarthritis (axSpA) starting their first tumour necrosis factor inhibitor in nine European registries were pooled and analysed. Receiver operating characteristic analyses were performed to identify cut-offs against external criteria.

Development of the Happy Hands Self-Management App for People with Hand Osteoarthritis: Feasibility Study.

Background: Patient education, hand exercises, and the use of assistive devices are recommended as first-line treatments for individuals with hand osteoarthritis (OA). However, the quality of care services for this patient group is suboptimal in primary care.

Objective: The overarching goal was to develop and evaluate feasibility of an app-based self-management intervention for people with hand OA.

Proactive therapeutic drug monitoring of biologic drugs in adult patients with inflammatory bowel disease, inflammatory arthritis, or psoriasis: a clinical practice guideline.

Clinical Question: In adult patients with inflammatory bowel disease, inflammatory arthritis (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis), or psoriasis taking biologic drugs, does proactive therapeutic drug monitoring (TDM) improve outcomes as compared with standard care?

Context And Current Practice: Standard care for immune mediated inflammatory diseases includes prescribing biologic drugs at pre-determined doses. Dosing may be adjusted reactively, for example with increased disease activity. In proactive TDM, serum drug levels and anti-drug antibodies are measured irrespective of disease activity, and the drug dosing is adjusted to achieve target serum drug levels, usually within pre-specified therapeutic ranges.

Reverse Shoulder Arthroplasty Is Superior to Plate Fixation for Displaced Proximal Humeral Fractures in the Elderly: Five-Year Follow-up of the DelPhi Randomized Controlled Trial.

Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Non-adherence to urate lowering therapy in gout after 5 years is related to poor outcomes-results from the NOR-Gout study.

Objectives: Patients with gout need to adhere to medication over time to achieve good outcomes. We assessed self-reported adherence to medication with urate lowering therapy (ULT) 5 years after a treat-to-target intervention and studied how non-adherence was related to baseline demographic and disease variables.

Methods: Patients in the NOR-Gout observational study were included after a recent gout flare and serum urate >360 µmol/L.