Recruiting patients with persistent physical symptoms and no specific diagnosis for clinical trials in primary care: a qualitative study of four scenarios.

ABSTRACT:

Aim

To investigate how to recruit patients rigosrously in general practice for trials based on symptoms as predefined inclusion criteria rather than a well-defined diagnosis. We used persistent physical symptoms (PPS) as a target condition.

Background

Conducting randomized controlled trials (RCTs) in general practice is crucial for evidence-based decision-making and treatment in frontline healthcare. However, recruitment is often challenged in general practice because many patients have vaguely defined conditions, such as PPS.

Methods

We used qualitative semi-structured interviews to explore the perspectives of general practitioners (GPs) on different recruitment scenarios, while paying particular attention to the logistics and feasibility in routine care. A total of 11 GPs from seven clinics were strategically recruited. The GPs were presented with one recruitment scenario (pre-consultation screening) and encouraged to suggest other scenarios. We conducted a thematic framework analysis of the interview material.

Findings

To ensure valid intervention research, one predefined scenario was discussed, and three additional scenarios were co-created during the interviews: (1) opportunistic screening, (2) pre-consultation screening, (3) audit (retrospective and prospective), and (4) random sample screening of the practice population. These scenarios differ with respect to logistical complexity, comparability to daily clinical practice, and entailed selection bias. Every scenario requires individual adaptation and implementation support to be feasible in routine care in general practice. The present study provides approaches for rigorous primary care research based on RCTs for frequent and vaguely defined conditions, but it also highlights a need to develop research methods better suited to frontline healthcare interventions.

SUBMITTER: Frumer M 

PROVIDER: S-EPMC12721981 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature