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Protocol Summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) Validation in Primary Care Study.

ABSTRACT: Chronic obstructive pulmonary disease (COPD) often remains undiagnosed and untreated. To date, COPD screening/case finding has not been designed to identify clinically significant COPD, disease ready for therapies beyond smoking cessation. Herein, we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool consisting of 5 questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (forced expiratory volume in 1 second [FEV₁] to forced vital capacity [FVC] ratio <.70 plus FEV₁% predicted <60% or increased risk for exacerbation) and the trial will explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients. Of a total planned enrollment of 5000 English- or Spanish-speaking patients 45 to 80 years of age without a prior COPD diagnosis from 100 primary care practices, a total of 68 practices and 3064 patients have been enrolled in the study. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete a CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes including level of respiratory symptoms and events and clinicians' initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.

SUBMITTER: Yawn BP

PROVIDER: S-EPMC8047605 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundGuideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care.ObjectiveWe aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials.MethodsBaseline data of seven primary care databases (n=3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria.ResultsOverall, patients included in the LPCS were younger (mean difference (MD)-2.4; p=0.03), predominantly male (MD 12.4; p=0.1) with worse lung function (FEV1% MD -16.4; p<0.01) and worse quality of life scores (SGRQ MD 15.8; p=0.01). There were large differences in GOLD stage distribution compared to primary care patients. Mean exacerbation rates were higher in LPCS, with an overrepresentation of patients with ≥ 1 and ≥ 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had ≥ 1 exacerbations per year and 12% had ≥ 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT).ConclusionPrimary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.

Project description:INTRODUCTION:The aetiology of acute exacerbations of chronic obstructive pulmonary disease (COPD) remains incompletely understood and strategies for treatment and prevention have not altered significantly for many years. Improved understanding of the role of respiratory pathogens in acute exacerbations of COPD (AECOPD) is required and the use of molecular microbiological techniques may lead to insights into host-pathogen interactions and the development of more targeted therapeutic approaches. METHODS AND ANALYSES:Acute Exacerbation and Respiratory InfectionS in COPD (AERIS) is a longitudinal epidemiological study to assess how changes in the COPD airway microbiome contribute to the incidence and severity of AECOPD. Patients with COPD aged 40-85 are followed monthly for 2 years, and reviewed within 72 h of onset of symptoms of AECOPD. Exacerbations are detected using daily electronic diary cards. Blood, sputum, nasopharyngeal and urine samples are collected at prespecified timepoints. Molecular diagnostic and typing techniques are used to describe the dynamics of airway infection during AECOPD and stable disease, and associations with clinical outcome. This study aims to refine the case definition of AECOPD to reflect the possible microbiological aetiology. AERIS will assess the impact of AECOPD on health-related quality of life and healthcare resource utilisation, and the possible interactions between nutritional status, infection and immune responses. ETHICS AND DISSEMINATION:AERIS is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice, and has been approved by the institutional ethics and review board. All participants must provide written informed consent. The results obtained will be disseminated at international medical conferences and in peer-reviewed publications. DISCUSSION:Few other studies have addressed the complexity of the microbiological and systemic components of COPD or employed real-time electronic tracking of symptoms to identify AECOPD and potential aetiological triggers. RESULTS:Results of AERIS will increase our understanding of the contribution of pathogens to AECOPD, potentially leading to new targeted therapeutic and preventative interventions. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov NCT01360398.

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Protocol Summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) Validation in Primary Care Study.

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