Abstract
BackgroundMany people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach.Methods/DesignIn this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach.DiscussionThis will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first.Trial registrationCurrent controlled trials ISRCTN14930255Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2466-14-157) contains supplementary material, which is available to authorized users.
Highlights
Many people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide
In this study, using a cluster randomised controlled trial (RCT) in general practices across the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice
(a) Targeted case finding versus Routine care cluster randomized design Based on the authors’ modelling work [32], the proportion of new COPD cases detected in the Targeted group was assumed to be 3.15%
Summary
This trial investigates the effectiveness and costeffectiveness of two alternative modes of systematic case-finding for COPD compared with routine care. There are many strengths of this study including: it is the first of this design based in a large sample of GP practices with a comparator group; it is set in a range of GP practices representative of urban UK; it has a pragmatic design which should reflect real life; the spirometry will be the best quality possible with highly trained staff and quality control; there will be a full cost-effectiveness analysis and sensitivity analyses to reflect a range of scenarios; the effects will be explored across the range of GPs involved, allowing the cost-effectiveness in different types of GPs to be assessed This trial should inform practice across the UK and elsewhere with similar healthcare systems, and help to direct current effort towards case-finding more efficiently. Identifying appropriate patients from GP databases with their complex coding is a known problem It is not known how patients will respond to questionnaires, and whether (or how often) it is practical for GP staff to give out screening questionnaires during routine visits. Authors’ information Principal Investigators: Dr Rachel Jordan, Professor Peymane Adab, Professor David Fitzmaurice
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