Background There is need to reduce delays to diagnosis for chronic breathlessness to improve patient outcomes.

Objective To conduct a mixed-methods feasibility trial of a larger cluster Randomised Controlled Trial (cRCT) investigating a structured symptom-based diagnostic approach versus usual care for chronic breathlessness in primary care

Methods Ten general practitioner (GP) practices were cluster randomised to a structured diagnostic approach for chronic breathlessness, including early investigations (intervention), or usual care. Adults over 40 years old at participating practices were eligible if presenting with chronic breathlessness, without existing diagnosis. The primary feasibility outcomes were participant recruitment and retention rate at one year. Secondary outcomes included number of investigations at three months, and number of diagnoses and patient reported outcome measures (PROMs) at one year.

Results Recruitment rate was 22% (48/220): 65% female, mean (SD) age 66 (11) years, BMI 31.2kg/m2 (6.5), median (IQR) MRC dyspnoea 2 (2–3). Retention rate was 85% (41/48). At three months, the intervention group had a median (IQR) of 8 (7–9) investigations compared with 5 (3–6) investigations in usual care. 11/25 (44%) patients in the intervention group had a coded diagnosis for breathlessness at 12 months compared with 6/23 (26%) in usual care. Potential improvements in symptom burden and quality of life were observed in the intervention group.

Conclusions A cRCT investigating a symptom-based diagnostic approach for chronic breathlessness is feasible in primary care showing potential for timely investigations and diagnoses, with PROMs indicating patient-level benefit. A further refined fully powered cRCT with health economic analysis is needed.

What is already known on this topic There are known delays to diagnosis for patients with long-term conditions commonly presenting with breathlessness. A structured symptom-based approach for breathlessness with early investigations may reduce delays and improve patient outcomes, but the clinical and cost effectiveness of such a pathway is unknown.

What this study adds We demonstrated that a future trial investigating a symptom-based structured diagnostic approach for breathlessness is feasible. Our results show participants in the intervention group had more investigations and earlier diagnoses alongside potential to reduce symptom burden.

How this study might affect research, practice or policy A symptom-based approach for breathlessness in primary care has the potential to reduce delays to diagnosis, improve outcomes for patients, and appears acceptable to patients and clinicians; refinement of the pathway and a fully powered cRCT with health economic modelling is needed.

The authors have declared no competing interest.

ISRCTN: 14483247

https://bmjopen.bmj.com/content/11/11/e057362

This work was funded by a NIHR Clinician Scientist Fellowship (CS-2016-16-020) awarded to Dr Rachael A Evans. Professor Natalie Armstrong is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and the NIHR Greater Manchester Patient Safety Research Collaboration. Gillian Doe was part funded by the Leicester Biomedical Research Centre, Respiratory, in addition to CS-2016-16-020.

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Nottingham 1 Research Ethics Committee (REC Reference: 19/EM/0201) gave ethical approval for this work. University of Leicester were the Research Sponsor.

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