Evidence map›Paper›PMID 34815293›Full record

ArticleBMJ open2021

Feasibility study of a multicentre cluster randomised control trial to investigate the clinical and cost-effectiveness of a structured diagnostic pathway in primary care for chronic breathlessness: protocol paper.

Gillian Doe, Jill Clanchy, Simon Wathall, Stacey Chantrell, Sarah Edwards, Noel Baxter, Darren Jackson, Natalie Armstrong, Michael Steiner, Rachael A Evans

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Selection and reporting of usual care comparators when designing primary care trials of complex health interventions: a systematic review.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
    Pooled it
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Gillian DoeRespiratory Sciences, University of Leicester, Leicester, UK.ORCID 0000-0003-4782-5811
Jill ClanchyLeicester Clinical Trials Unit, University of Leicester, Leicester, UK.
Simon WathallInstitute of Primary Care and Health Sciences, Keele University, Staffordshire, UK.
Stacey ChantrellNIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK.
Sarah EdwardsNIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK.
Noel BaxterInternational Primary Care Respiratory Group, London, UK.
Darren JacksonBarwell & Hollycroft Medical Centres, Leicester, UK.
Natalie ArmstrongHealth Sciences, University of Leicester, Leicester, UK.
Michael SteinerRespiratory Sciences, University of Leicester, Leicester, UK.
Rachael A EvansRespiratory Sciences, University of Leicester, Leicester, UK re66@leicester.ac.uk.ORCID 0000-0002-1667-868X
University of Leicester · GBUniversity Hospitals of Leicester NHS Trust · GBKeele University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care. METHODS AND ANALYSIS: Ten general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is 'usual care' and the study experience. ETHICS AND DISSEMINATION: The Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available. TRIAL REGISTRATION NUMBER: ISRCTN14483247.

Indexed as

Primary Health CareQuality of LifeAdultCost-Benefit AnalysisDyspneaFeasibility StudiesHumansMulticenter Studies as TopicRandomized Controlled Trials as Topicprimary carequalitative researchquality in health carerespiratory medicine (see thoracic medicine)

Identifiers

PMID34815293
PMCPMC8611440
OpenAlexW3216029254

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.