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Co-developing a vocational rehabilitation intervention for individuals with chronic low back pain across a regional spine centre and three municipalities in Denmark: a three-stage intervention development study guided by the Medical Research Council frame

Por: Frydenlund · G. · Mortensen · O. S. · ONeill · S. · Sondergaard · J. · Hansen · A.
Objectives

To co-develop the Stay-At-Work (SAW) intervention, a person-centred, interdisciplinary, cross-sectoral vocational rehabilitation (VR) programme for individuals on, or at risk of, sick leave due to chronic low back pain (CLBP) and to advance methodological understanding of how evidence, qualitative insights, stakeholder input and programme theory can be systematically integrated and operationalised into concrete intervention components.

Design

A three-stage intervention development study, guided by the Medical Research Council framework for complex interventions, involving evidence review and stakeholder consultation (previously reported); multistakeholder co-design; and prototyping in clinical settings.

Setting

The intervention was developed within a Danish public healthcare and welfare context, involving a secondary care spinal service, municipal employment services (n=3), municipal rehabilitation services (n=3) and general practice.

Participants

Stage 1: 17 individuals on long-term sick leave due to CLBP participated in interviews and focus groups. Stages 2 and 3: The co-design group included individuals living with CLBP (n=2); clinicians from a secondary care spine service (n=2) and municipal rehabilitation services (n=6); general practitioners (n=2); municipal employment service professionals (n=3) and local managers (n=3); and employer and employee representatives (n=2). Participants were purposively recruited based on their roles and experience in VR and return-to-work processes and contributed across different stages of intervention development.

Results

The SAW intervention consists of eight structured activities, developed through multistakeholder co-design and underpinned by a programme theory with four core mechanisms: (1) strengthened interprofessional and cross-sectoral understanding and collaboration; (2) stronger alignment around functional capacity and work ability; (3) addressing psychological vulnerability through systematic screening and support; and (4) enhanced coordination of care and rehabilitation efforts across services.

Stakeholder input from the co-design group informed the intervention’s content and procedures, thereby improving alignment with local contexts and strengthening cross-sector collaboration. Some proposals were excluded due to inconsistency with clinical guidelines.

Conclusion

This study demonstrates how a structured, theory-informed co-development process can be used to integrate evidence, stakeholder input and programme theory into a coherent, cross-sectoral VR intervention. The approach enhanced transparency, supported alignment with real-world practice, and provides methodological insight to strengthen the reproducibility and transferability of complex interventions.

Registration number: The Region of Southern Denmark’s Research Registry (journal no. 23/44927).

Study protocol for the investigator-initiated Danish pragmatic randomised STENO INTEN-CT trial: does screening and intervention for subclinical coronary artery disease in type 2 diabetes reduce cardiovascular events?

Por: Funck · K. L. · Borregaard · B. · Egstrup · K. · Fredslund · E. K. · Hansen · T. W. · Kallestrup · P. · Olsen · M. H. · Reventlow · S. · Rossing · P. · Sandbaek · A. · Sondergaard · J. · Thomsen · J. L. · Vestergaard · P. · Poulsen · P. L. · Diederichsen · A.
Introduction

Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).

Methods and analysis

The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.

Ethics and dissemination

The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.

Trial registration number

NCT05700877.

Patient experiences with group consultations when treated with semaglutide for obesity: a qualitative case study in a Danish general practice

Por: Dahl-Larsen · R. · Jakobsen · P. · Sondergaard · J. · Henriksen · J. E. · Assing Hvidt · E.
Objective

In this case study conducted in a Danish general practice, we aimed to explore how patients with obesity experience a novel treatment approach: group consultations (GCs) for weight loss, lifestyle changes and semaglutide treatment. To receive semaglutide treatment, patients were required to participate in GCs focused on lifestyle changes.

Design

A qualitative study design comprising individual, semistructured interviews was used. Patients were asked to reflect on and describe their past experiences with participating in GCs. Thematic analysis was used as an analytical strategy.

Setting

A general practice located in a larger city in the Region of Southern Denmark.

Participants

12 patients (eight women and four men) with obesity, aged between 27 years and 69 years, who met the Danish obesity treatment criteria for semaglutide (body mass index over 30 kg/m2 or over 27 kg/m2 with comorbidities), were included. Data were collected from 1 November 2023 to 31 January 2024.

Results

Before attending GCs, patients were worried about sharing personal information with other patients and losing their confidentiality. They also feared being judged by the others in the group, possibly due to previous experiences of stigmatisation. However, after participating in GCs, patients reported positive experiences with peer sharing, had no issues with confidentiality and found the consultations beneficial. Most patients indicated a preference for GCs over one-on-one consultations in the future.

Conclusions

Despite initial concerns about confidentiality and stigmatisation, patients ultimately had positive experiences and gained valuable peer support during group GCs in general practice. Various aspects of the group design, such as the hybrid consultation format and the role of the facilitator, may impact the effectiveness of peer support and influence patients’ overall experience of GCs.

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