Background There is a need to reduce delays to diagnosis for chronic breathlessness to improve patient outcomes.Objective To conduct a mixed-methods feasibility study 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 10 general practitioner practices were cluster randomised to a structured diagnostic approach for chronic breathlessness including early parallel investigations (intervention) or usual care. Adults over 40 years old at participating practices were eligible if presenting with chronic breathlessness without an existing explanatory diagnosis. The primary feasibility outcomes were participant recruitment and retention rate at 1 year. Secondary outcomes included number of investigations at 3 months, and investigations, diagnoses and patient-reported outcome measures (PROMs) at 1 year. Semistructured interviews were completed with patients and clinicians, and analysed using thematic analysis.Results Recruitment rate was 32% (48/150): 65% female, mean (SD) age 66 (11) years, body mass index 31.2 kg/m2 (6.5), median (IQR) Medical Research Council dyspnoea 2 (2–3). Retention rate was 85% (41/48). At 3 months, the intervention group had a median (IQR) of 8 (7–9) investigations compared with 5 (3–6) investigations with usual care. 11/25 (44%) patients in the intervention group had coded diagnosis for breathlessness at 12 months compared with 6/23 (26%) with usual care. Potential improvements in symptom burden and quality of life were observed in the intervention group above usual care.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 potentially indicating patient-level benefit. A further refined fully powered cRCT with health economic analysis is needed.

Background There are known delays to diagnosis for diseases which commonly present with chronic breathlessness, but the subsequent impact is unknown. For adults presenting with breathlessness, we investigated the time taken to achieve an explanatory diagnosis, and associations with unplanned hospitalisation and mortality.Methods A retrospective cohort study using the UK CPRD was conducted involving adults with a first-recorded code for breathlessness and no pre-existing cardiorespiratory disease. We documented whether an explanatory diagnosis was recorded after the first code of breathlessness within two years and during all follow-up, and the time to diagnosis. Cox regression (adjusted) was used to investigate the associations with unplanned hospitalisation and mortality.Results 101369 adults were included with a first-recorded code for breathlessness. After two-years, 43394 (43%) adults received a recorded explanatory diagnosis and had a higher risk of unplanned hospitalisation (1.25 [1.19-1.31]) and mortality (2.06 [1.60-2.65]) compared to adults without a diagnosis. Overall, 66909 (66%) adults received a recorded diagnosis during a median of 5-years follow-up. Adults that received a recorded diagnosis after ≥6 months had worse outcomes of unplanned hospitalisation (6-24 months: 1.01 [0.94-1.08]; ≥24 months: 1.13 [1.06-1.20]) and mortality (6-24 months: 3.38 [2.21-5.18]; ≥24 months: 10.80 [7.46-15.70]).Conclusion We describe a sub-group of adults coded for breathlessness but without an explanatory diagnosis with better outcomes. However, in adults with an explanatory diagnosis waiting beyond six months was associated with worse outcomes. Diagnostic pathways for chronic breathlessness need to differentiate between these two groups and achieve earlier diagnosis in those at higher risk.What is already known on this topic? What this study adds How this study might affect research, practice or policy ### Competing Interest StatementKK is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and the NIHR Leicester Biomedical Research Centre (BRC).### Funding StatementUK is funded by a National Institute for Health Research (NIHR) Biomedical Research Council (BRC) / Leicester Precision Medicine Institute (LPMI) Studentship. RAE is funded by a NIHR Clinician Scientist Fellowship CS-2016-16-020. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.### Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This study was approved by Independent Scientific Advisory Committee for Medicines and Healthcare products Regulatory Agency database research (Protocol Number = 20_075). This study is based in part on data from the Clinical Practice Research Datalink obtained under licence from the UK Medicines and Healthcare products Regulatory Agency.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.YesThe study uses data from the Clinical Practice Research Datalink (CPRD). CPRD does not allow the sharing of patient-level data.

Introduction Spirometry is a point-of-care lung function test that helps support the diagnosis and monitoring of chronic lung disease. The quality and interpretation accuracy of spirometry is variable in primary care. This study aims to evaluate whether artificial intelligence (AI) decision support software improves the performance of primary care clinicians in the interpretation of spirometry, against reference standard (expert interpretation).Methods and analysis A parallel, two-group, statistician-blinded, randomised controlled trial of primary care clinicians in the UK, who refer for, or interpret, spirometry. People with specialist training in respiratory medicine to consultant level were excluded. A minimum target of 228 primary care clinician participants will be randomised with a 1:1 allocation to assess fifty de-identified, real-world patient spirometry sessions through an online platform either with (intervention group) or without (control group) AI decision support software report. Outcomes will cover primary care clinicians’ spirometry interpretation performance including measures of technical quality assessment, spirometry pattern recognition and diagnostic prediction, compared with reference standard. Clinicians’ self-rated confidence in spirometry interpretation will also be evaluated. The primary outcome is the proportion of the 50 spirometry sessions where the participant’s preferred diagnosis matches the reference diagnosis. Unpaired t-tests and analysis of covariance will be used to estimate the difference in primary outcome between intervention and control groups.Ethics and dissemination This study has been reviewed and given favourable opinion by Health Research Authority Wales (reference: 22/HRA/5023). Results will be submitted for publication in peer-reviewed journals, presented at relevant national and international conferences, disseminated through social media, patient and public routes and directly shared with stakeholders.Trial registration number NCT05933694.

Introduction: Spirometry services to diagnose lung disease in primary care are slowly restarting in England post-pandemic; evidence regarding best practice is limited. Aim: Explore perspectives on spirometry provision and potential for Artificial Intelligence (AI) decision support software to aid quality and interpretation in future pathways. Methods: Semi-structured interviews were conducted with key stakeholders in spirometry services across England, recruited by snowball sampling. Interviews explored the pre-pandemic delivery of spirometry, restarting of services and perceptions of the role of AI. Transcripts were analysed using thematic analysis. Results: 28 participants (mean [SD], 21.6 [9.4] years' clinical experience) were interviewed April-June 2022. Participants included 25 clinicians and 3 commissioners; 8 held regional and/or national respiratory network roles. Four themes were identified: 1) Historical challenges in spirometry provision; 2) Inequity in post-pandemic spirometry provision and challenges to restarting spirometry in primary care; 3) Future delivery closer to patients' homes by appropriately trained staff; 4) The potential for AI to have supportive roles in spirometry. Conclusion: Stakeholders highlighted historic challenges and the damaging effects of the pandemic contributing to inequity in provision of spirometry nationally. Overall, stakeholders were positive about the potential of AI. Family doctors in particular were keen to explore its role in supporting clinicians in quality assessment and interpretation of spirometry. It was evident that validation of the software and trust in the process would be key for future implementation.

BackgroundEvidence about the delays to diagnosis for patients presenting with breathlessness is lacking.AimTo explore current care of patients with breathlessness through the experiences of adults presenting with chronic breathlessness who are awaiting a diagnosis and the experiences of primary care clinicians.Design and settingQualitative study with adults presenting with chronic breathlessness and clinicians across 10 general practices.MethodSemi-structured interviews were conducted with patients and clinicians. Participants were recruited from a feasibility cluster randomised controlled trial investigating a structured diagnostic pathway for breathlessness. An interview guide explored experiences of help seeking for breathlessness, the diagnostic process, and associated health care. Transcripts were analysed using thematic analysis supported by NVivo software.ResultsInterviews were conducted with 34 patients (mean age 68 years, standard deviation [SD] 10.8, of whom 20 were female [59%]) and 10 clinicians (mean 17 years of experience, SD 6.3, of whom five were female [50%]). Five themes were identified: recognising and validating symptoms of breathlessness is an important first step; clinical decision making for breathlessness is complex; difficult conversations arise when a disease-related diagnosis is not confirmed; disease management rather than symptom management is prioritised by clinicians; and patient experience is influenced by clinician communication style.ConclusionThe findings indicate potential explanations for delays to diagnosis for patients with chronic breathlessness. Interventions are needed to enhance symptom recognition, include alternative approaches to incremental investigation, and expand the concept of diagnosis beyond a disease label to improve communication, with the ultimate aim of earlier diagnosis and management to improve patient outcomes.

Background Primary care spirometry is advocated as a means of facilitating earlier diagnosis of respiratory disease. However spirometry may be normal in the early stages of ILD. Aim To determine the prevalence of ILD in symptomatic individuals with normal primary care spirometry, and the predictive ability of spirometric parameters to identify ILD. Methods From a retrospective cohort of 1121 individuals with respiratory symptoms attending primary care clinics for spirometry, 190 had normal spirometry (FVC >-1.64 standardized residuals (SR) and FEV1:FVC >-1.64 SR according to ERS/ATS 2021 Technical Standard on Interpretative Strategies). Final diagnosis was determined by consensus of respiratory physicians with access to full medical notes and results of further investigations. ROC plots were constructed to compare discriminatory ability of spirometric parameters to identify ILD. Results Fifty five (29%) were identified as having an ILD. Compared to those without ILD, individuals with ILD were older with higher FEV1:FVC ratio. FEV1:FVC SR was the best predictor of ILD, with a FEV1:FVC SR >-0.256 having an AUC of 0.766, sensitivity of 71% and specificity of 71% (Figure 1). Conclusion In symptomatic individuals, even with normal primary care spirometry, primary care practitioners should have a high index of suspicion for ILD with low threshold for referring for full pulmonary function tests or imaging.

Background Spirometry services to diagnose and monitor lung disease in primary care were identified as a priority in the NHS Long Term Plan, and are restarting post-COVID-19 pandemic in England; however, evidence regarding best practice is limited. Aim To explore perspectives on spirometry provision in primary care, and the potential for artificial intelligence (AI) decision support software to aid quality and interpretation. Design and setting Semi-structured interviews with stakeholders in spirometry services across England. Method Participants were recruited by snowball sampling. Interviews explored the pre- pandemic delivery of spirometry, restarting of services, and perceptions of the role of AI. Transcripts were analysed thematically. Results In total, 28 participants(mean years' clinical experience = 21.6 [standard deviation 9.4, range3-40])were interviewed between April and June 2022. Participants included clinicians (n = 25) and commissioners (n = 3); eight held regional and/or national respiratory network advisory roles.Four themes were identified: 1) historical challenges in provision of spirometry services; 2) inequity in post-pandemic spirometry provision and challenges to restarting spirometry in primary care; 3)future delivery closer to patients' homes by appropriately trained staff; and 4) the potential for AI to have supportive roles in spirometry. Conclusion Stakeholders highlighted historic challenges and the damaging effects of the pandemic contributing to inequity in provision of spirometry, which must be addressed. Overall, stakeholders were positive about the potential of AI to support clinicians in quality assessment and interpretation of spirometry. However, it was evident that validation of the software must be sufficiently robust for clinicians and healthcare commissioners to have trust in the process.

Tweetable abstract The negative results of the TANDEM study prompts us to consider how we can best manage mood disorders in #COPD and enable #pulmonaryrehabilitation. Approaches to enhance both patient and healthcare professional activation are needed.https://bit.ly/3F3USVF

Two recruitment strategies for research were compared to prospectively identify patients with breathlessness who are awaiting a diagnosis in primary care. The first method utilised searches of the electronic patient record (EPR), the second method involved an electronic template triggered during a consultation. Using an electronic template triggered at the point of consultation increased recruitment to prospective research approximately nine-fold compared with searching for symptom codes and study mailouts.

Aim To describe experiences during the COVID-19 pandemic of people living with chronic breathlessness without a diagnosis. Methods As part of a wider mixed methods study (Breathlessness - DiagnosE Early in Primary care: Breathe-DEEP), semi-structured interviews were undertaken with people referred for investigation of chronic breathlessness across ten GP practices. The interview guide included questions around experiences of breathlessness, healthcare interactions and the impact of COVID-19 pandemic. Telephone interviews were audio-recorded, transcribed, coded and reviewed by the study team using thematic analysis. Results Over six weeks during the UK lockdown for the COVID-19 pandemic, 20 participants were interviewed (12 female, mean age 65 yrs). Five participants lived alone, two were working and three recently received a confirmed diagnosis for their breathlessness. None of the participants experienced COVID-19. Three key themes were identified. Unintentional de–prioritisation of diagnosis by patients. The COVID–19 pandemic has led to a reduction in seeking healthcare for this group. Some described their breathlessness as a 'non–urgent' problem, and others felt worried about burdening their GP and the National Health Service (NHS) at this time. Following UK 'lockdown' guidance for the general population, is this enough? This group are not identified as vulnerable but have a clear perception that they are at increased risk if they were to contract COVID–19. Impact of lockdown on coping strategies for managing breathlessness. People have expressed modified behaviour to help them cope with lockdown. Some people are obliged by the nature of lockdown to use disengaged coping strategies which has a negative impact on managing their breathlessness and mental health. Conclusion The existing unpredictable pathway to diagnosis for people living with chronic breathlessness has been further interrupted during the COVID-19 pandemic. People expressed concern about only following general population advice, rather than shielding, due to not having a diagnosis. Patients and clinicians need to re-engage with the pathway to diagnosis and management of chronic breathlessness.

During the COVID-19 pandemic, semi-structured interviews were undertaken with 20 adults awaiting a diagnosis for their chronic breathlessness. Three key themes were identified using thematic analysis: (1) de-prioritisation of diagnosis, (2) following UK ‘lockdown’ guidance for the general population but patients fearful they were more at risk, and (3) the impact of lockdown on coping strategies for managing breathlessness. The existing unpredictable pathway to diagnosis for those with chronic breathlessness has been further interrupted during the COVID-19 pandemic.

INTRODUCTION:Chronic 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.