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Targeted case finding for chronic obstructive pulmonary disease versus routine practice in primary care (TargetCOPD): a cluster-randomised controlled trial

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Summary

Background

Many individuals with chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. Health-care organisations are implementing case-finding programmes without good evidence of which are the most effective and cost-effective approaches. We assessed the effectiveness and cost-effectiveness of two alternative approaches to targeted case finding for COPD compared with routine practice.

Methods

In this cluster-randomised controlled trial, participating general practices in the West Midlands, UK, were randomly assigned (1:1), via a computer-generated block randomisation sequence, to either a targeted case-finding group or a routine care group. Eligible patients were ever-smokers aged 40–79 years without a previously recorded diagnosis of COPD. Patients in the targeted case-finding group were further randomly assigned (1:1) via their household to receive either a screening questionnaire at the general practitioner (GP) consultation (opportunistic) or a screening questionnaire at the GP consultation plus a mailed questionnaire (active). Respondents reporting relevant respiratory symptoms were invited for post-bronchodilator spirometry. Patients, clinicians, and investigators were not masked to allocation, but group allocation was concealed from the researchers who performed the spirometry assessments. Primary outcomes were the percentage of the eligible population diagnosed with COPD within 1 year (defined as post-bronchodilator forced expiratory volume in 1 s [FEV1] to forced vital capacity [FVC] ratio <0·7 in patients with symptoms or a new diagnosis on their GP record) and cost per new COPD diagnosis. Multiple logistic and Poisson regression were used to estimate effect sizes. Costs were obtained from the trial. This trial is registered with ISRCTN, number ISRCTN14930255.

Findings

From Aug 10, 2012, to June 22, 2014, 74 818 eligible patients from 54 diverse general practices were randomly assigned and completed the trial. At 1 year, 1278 (4%) cases of COPD were newly detected in 32 789 eligible patients in the targeted case-finding group compared with 337 (1%) cases in 42 029 patients in the routine care group (adjusted odds ratio [OR] 7·45 [95% CI 4·80–11·55], p<0·0001). The percentage of newly detected COPD cases was higher in the active case-finding group (822 [5%] of 15 378) than in the opportunistic case-finding group (370 [2%] of 15 387; adjusted OR 2·34 [2·06–2·66], p<0·0001; adjusted risk difference 2·9 per 100 patients [95% CI 2·3–3·6], p<0·0001). Active case finding was more cost-effective than opportunistic case finding (£333 vs £376 per case detected, respectively).

Interpretation

In this well established primary care system, routine practice identified few new cases of COPD. An active targeted approach to case finding including mailed screening questionnaires before spirometry is a cost-effective way to identify undiagnosed patients and has the potential to improve their health.

Funding

National Institute for Health Research.

Introduction

Chronic obstructive pulmonary disease (COPD) is a common long-term respiratory disorder with high health-care and societal burden,1 with estimated annual costs of US$50 billion (2010) to the US1 and €48·6 billion (2011) to the EU economies.2 Worldwide, the diagnosed prevalence of COPD is estimated to be about 5% of adults older than 40 years,3 but at least an equivalent number of people with significant symptomatic COPD remain undiagnosed and could potentially benefit from effective interventions.4, 5 There is a worldwide drive to identify these “missing millions”6, 7, 8, 9 and many health-care organisations are implementing case-finding programmes, although without good evidence of which are the most effective and cost-effective approaches.

There are several reports of uncontrolled studies of case finding, with heterogeneous populations, interventions, and case definitions.10 However, only one published randomised controlled trial, within family medical practices in the USA, has assessed a systematic approach to identifying previously undiagnosed clinical COPD compared with usual care.11 This study showed that initial opportunistic administration of a screening questionnaire was twice as effective as usual care in identifying new cases of COPD. Other uncontrolled studies have suggested that sending a screening questionnaire by post before spirometry assessment is a promising alternative method,10 but the comparative effectiveness and cost-effectiveness of the two approaches have not been tested.

Research in context

Evidence before this study

Chronic obstructive pulmonary disease (COPD) is substantially underdiagnosed worldwide. Mass population screening with spirometry is not recommended, although early identification of undiagnosed patients with clinical disease is generally supported because COPD has substantial patient, health-care, and societal burden, which could potentially be lessened through timely diagnosis. We undertook a comprehensive systematic review of the effectiveness of case-finding studies, published in 2015, using synonyms for the search terms COPD, case-finding screening tests in MEDLINE and Embase with no language restrictions. We found 39 published studies, but few included a comparator group. Only one randomised controlled trial has compared a case-finding approach with routine care to identify clinically significant COPD, identifying that opportunistic administration of a screening questionnaire at practice visits was twice as effective as routine care. Non-comparative studies suggest that high yields could be achieved from active case finding with mailed questionnaires to high-risk patients. No previous trial has compared the clinical and cost-effectiveness of alternative approaches to case finding in a real-life primary care setting.

Added value of this study

To our knowledge, TargetCOPD is the first randomised controlled trial to assess the effectiveness and cost-effectiveness of active case finding for COPD compared with opportunistic case finding and to compare these approaches with routine care. In 54 general practices, we found that when targeting ever-smokers aged 40–79 years, active case finding was more than twice as effective as opportunistic case finding, and that together, these targeted approaches were more than seven times as effective as current routine care. Active case finding was also more cost-effective than opportunistic case finding.

Implications of all the available evidence

In a real-life setting, active case finding comprising an initial mailed questionnaire followed by spirometry should be recommended for identifying undiagnosed COPD in primary care. An important proportion of these previously undiagnosed patients have significant breathlessness, and earlier identification and management with effective treatments including inhalers and pulmonary rehabilitation has the potential to improve their health. This trial provides the evidence for guidelines, which was previously lacking.

Modelling of observational data has suggested that an active approach (including both mailed questionnaires and opportunistic administration) could be twice as effective as an opportunistic-only approach, and identify patients with significant potential to benefit from treatment.4 This large, pragmatic, cluster-randomised controlled trial investigated the effectiveness and cost-effectiveness of these two methods of identifying undiagnosed COPD in a UK primary care setting.

Section snippets

Study design and participants

TargetCOPD was a pragmatic cluster-randomised controlled trial comparing an active and an opportunistic targeted approach to case finding for undiagnosed COPD versus routine practice in primary care. Details of our study design have been published elsewhere.12 UK ethical and research governance approvals were obtained. All 354 general practices (family medical practices) in the Birmingham and Black Country region of the West Midlands, UK, were invited to take part. Automated computer searches

Results

56 general practices agreed to participate (appendix), but two withdrew before randomisation (figure). Practices took part between Aug 10, 2012, and June 22, 2014. No practices were lost to follow-up by 1 year.

Practice and participant characteristics were well balanced between targeted case finding and routine care groups (table 2), although the routine care group (42 029 patients) was larger than the targeted case-finding group (32 811 patients) with some slight differences in distribution of

Discussion

The identification of undiagnosed COPD remains an important priority worldwide. Despite little available evidence, national guidelines recommend opportunistic case finding in the primary care setting.15 In our large, generalisable, real-life randomised controlled trial, very few new cases were identified in routine care. As expected, we showed that a systematic targeted approach was markedly more effective than routine care at identifying new cases of COPD. More importantly, we found that an

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