Comparing performance of primary care clinicians in the interpretation of SPIROmetry with or without Artificial Intelligence Decision support software (SPIRO-AID): a protocol for a randomised controlled trial.

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.

Spirometry services in England post-pandemic and the potential role of AI support software: a qualitative study of challenges and opportunities.

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, range 3-40]) 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.

Diagnostic delays for breathlessness in primary care: a qualitative study to investigate current care and inform future pathways.

BACKGROUND: Evidence about the delays to diagnosis for patients presenting with breathlessness is lacking. AIM: To 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 SETTING: Qualitative study with adults presenting with chronic breathlessness and clinicians across 10 general practices. METHOD: Semi-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. RESULTS: Interviews 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. CONCLUSION: The 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.

Comparing research recruitment strategies to prospectively identify patients presenting with breathlessness in primary care.

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.

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.

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.

Breathless and awaiting diagnosis in UK lockdown for COVID-19 We're stuck.

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.