TargetCOPD: a pragmatic randomised controlled trial of targeted case finding for COPD versus routine practice in primary care: protocol

BMC Pulmonary Medicine

David A Fitzmaurice⁴  Amanda Daley⁴  Stanley Siebert²  Sheila Greenfield⁴  Robert A Stockley³  Kate Jolly⁴  Kar Keung Cheng⁴  Jon G Ayres⁴  Alice M Turner¹  Brendan G Cooper³  Martin R Miller⁴  Alexandra Enocson⁴  Richard D Riley⁴  Jen L Marsh⁴  Sue Jowett⁴  Peymané Adab⁵  Rachel E Jordan⁴ 

[1] Queen Elizabeth Hospital Research Laboratories, Mindelsohn Way, Birmingham, UK;Business School, University of Birmingham, Birmingham, UK;Lung Investigation Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK;School of Health and Populations Sciences, University of Birmingham, Birmingham, UK;Public Health, Epidemiology & Biostatistics, Public Health Building, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK

关键词: Cost-effectiveness;    Cluster RCT;    Spirometry;    Respiratory questionnaire;    Primary care;    Screening;    Case-finding;    COPD;   

Others  :  1091938
DOI  :  10.1186/1471-2466-14-157

 received in 2014-09-15, accepted in 2014-09-26,  发布年份 2014

【 摘 要 】

Background

Many 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/Design

In 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.

Discussion

This 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 registration

Current controlled trials ISRCTN14930255

【 授权许可】

   
2014 Jordan et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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