Diagnostic pathways for patients with chronic breathlessness.
Research type
Research Study
Full title
A feasibility study of a multi-centre cluster randomised controlled trial (RCT) to investigate whether a new diagnostic pathway is clinically and cost-effective for older adults presenting with chronic breathlessness.
IRAS ID
261499
Contact name
Rachael Evans
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
6 years, 2 months, 1 days
Research summary
Research Summary
This is a feasibility study to understand what the practicalities are of running a larger trial. The larger trial will be a cluster randomised controlled trial to investigate a novel diagnostic pathway, to include a panel of simple early investigations, for patients with breathlessness in primary care. We will aim to determine the cluster and sample size required for the larger trial.
This study will aim to recruit GP practices form Leicestershire, Leicester and Northamptonshire who will be randomised to an intervention or usual care group. The GPs in the intervention group will use the new diagnostic pathway and early investigations. The usual care GP group will continue with their normal practice. Usual care will be standardised by directing clinicians to the NICE Clinical Knowledge Summary on Breathlessness (2017) . The Clinical Knowledge Summary advocates the same investigations as we describe in the Diagnostic Pathway but without a stipulated timeframe.
Time to diagnosis will be recorded.Patients aged over 40 years old attending a GP consultation for breathlessness lasting longer than two months will be invited to take part in the study.
Participants will be asked to attend two research visits at the Biomedical Research Centre at Glenfield Hospital where outcome measures such as walk tests, balance and strength, body composition, physical activity and health status (using questionnaires) will be collected. There will also be patient and GP interviews to help understand their experiences of taking part in the study and help inform the larger trial.The overall aim is to establish if a new diagnostic pathway for chronic breathlessness is clinically and cost effective.
Lay Summary of Results
What was already known?
People with long‑term health conditions that cause breathlessness often wait years before getting a correct diagnosis. One idea to speed this up is to use a structured approach in GP surgeries that focuses on the symptom of breathlessness itself and carries out several tests early and in parallel. It isn't known whether this kind of approach works in practice or is good value for money.What this study found
This study showed that it is possible to run a larger trial testing this structured breathlessness pathway. Out of the 15 GP practices invited to take part in the study, 10 agreed. All of the GP practices had more than 10,000 patients.
48 of 150 people contacted (32%) agreed to take part between November 2019 and February 2021. Of those who joined the study, about two‑thirds were women and the average age was 66 years old. Most participants had moderate levels of breathlessness (Medical Research Council dyspnoea score median of 2 [interquartile range 2-3]) Recruitment varied across GP practices: some practices enrolled only one patient, while others recruited up to eleven.
The COVID‑19 pandemic began in March 2020 and affected recruitment. Before the pandemic (November 2019 to March 2020), recruitment rate was was higher (42%) with 36 participants joining during that early period.
After 12 months, more patients in the intervention group received a recorded (coded) diagnosis for the cause of their breathlessness compared with those receiving usual care. Specifically, 11 out of 25 people in the intervention group (44%) were diagnosed, compared with 6 out of 23 people (26%) in the usual care group.
A statistical analysis was carried out to explore how long it took for patients to receive a diagnosis. This suggested that patients in the intervention group were more likely to be diagnosed sooner. They appeared to have a 78% higher chance of getting a diagnosis during the study period than those in usual care. However, this difference was not statistically significant.
When looking at the patient‑reported outcome measures (PROMs), the intervention group showed bigger improvements over 12 months than the usual care group. These improvements were greater than the 'minimal clinically important difference,' which is the smallest change that patients would typically notice or find meaningful.
The areas where the intervention group improved more included:
- Overall symptom burden
- Quality of life
- Breathlessness perception and emotional response (measured by the MDP questionnaire)
- Breathlessness severity (Dyspnoea‑12 questionnaire)
- Health‑related quality of life (EQ‑5D‑5L Utility Index) There was no meaningful difference between the two groups in levels of anxiety or depression, as measured by the Hospital Anxiety and Depression Scale.
All participants interviewed reported that taking part in the study was a positive experience.Our results suggest that focusing on breathlessness as a symptom-based approach in primary care may help patients get diagnosed sooner, feel better, and receive appropriate treatment earlier. Both patients and clinicians found this approach acceptable.
What this means for the future
Our findings suggest that carrying out several tests early and at the same time, within a structured breathlessness assessment, may be helpful for patients. To fully understand whether it improves patient outcomes and offers good value for money, a larger, fully powered trial that includes an economic evaluation will be required.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0201
Date of REC Opinion
5 Aug 2019
REC opinion
Further Information Favourable Opinion