Title: COPD in primary care: from case finding to improving patient outcomes
Funder: Department of Health and Social Care

Abstract: Background COPD is an important health problem, accounting for significant health service and societal costs. However the natural history and factors affecting prognosis are poorly understood and interventions for early disease are limited. There is also considerable underdiagnosis, resulting in potential unmet need. In the UK there is interest in identifying these missing cases with diverse local initiatives, but no evidence of the most efficient approach. This programme comprises 4 workpackages (WP) to address some of these issues. Aims & objectives The overall aim is to set up a primary care COPD cohort including the full range of disease severity, as a platform for testing novel health service interventions. Specifically to: 1. Ascertain the cost-effectiveness of the addition of active case finding, compared with opportunistic-only case finding for COPD in primary care (WP1) 2. Test the validity of existing COPD prognostic indices in a primary care COPD population and develop an improved prognostic index (WP2) 3. Identify factors associated with employment, absenteeism and presenteeism among those with COPD of working age (WP3) 4. Assess feasibility and benefits of formal occupational health assessment among those with poor work performance (WP3) 5. Assess feasibility and acceptability of a pilot intervention to promote home-based exercise among COPD patients with mild dyspnoea and mild/moderate airflow obstruction (WP4) Research plans & outputs WP1 is a randomised controlled trial to compare the effectiveness and cost-effectiveness of active versus opportunistic case finding for COPD. This will inform national policy on the most efficient approach to identifying clinically relevant cases, who can benefit from evidence based management. WP2 is the inception of the COPD cohort with 3-yr follow-up to investigate prognosis. New cases identified through WP1 will be invited to participate. In addition, all adults with documented COPD diagnosis from practices will be invited, with the aim of recruiting 2000 in total. Baseline measures will be undertaken with 6-monthly follow up for at least 3 years. A better understanding of factors that determine prognosis, particularly those that are modifiable, is essential for informing patient management decisions, and facilitating doctor patient relationships. Thus a number of prognostic indices have been developed, based on people with more advanced COPD. We will use the data collected for the cohort to examine the validity of these indices in a primary care COPD population and modify or develop a more appropriate index. This will benefit patient management in primary care, where the majority of COPD patients are cared for. The well characterised cohort will also form a platform for other health service related research within this programme and in future. A significant proportion of those with COPD are of working age, but unemployment and absenteeism rates are higher than in the general population. WP3 will use data from the cohort to examine the relationship between COPD severity and employment, occupational performance and productivity. This will inform management of COPD in workplaces, and who should be targeted for workplace interventions. A sample of patients with COPD with poorer work performance will take part in a feasibility study with an occupational health assessment and recommendations aimed at improving performance. This will inform whether such intervention has potential benefit and is feasible. Currently there are relatively few effective interventions for those with mild/moderate CODP. WP4 will focus on this group, conducting an exploratory trial to assess the feasibility and acceptability of increasing physcial activity. This will inform a future definitive trial to assess the effectiveness of the intervention in modifying disease. Research team & environment Our multidisciplinary team consists of NHS and academic partners with subject and methodological expertise across a breadth of disciplines, and proven track record (through research funding, publications and serving on relevant committees) in related health services research. The PIs are supported by a primary care research network with excellent reputation in recruitment and retention to similar studies. The West Midlands, where the proposal is set, has a growing reputation in respiratory research, with recent key appointments to facilitate this. PPI The programme has been developed in consultation with a lay representative, who has suggested some amendments, and agreed to lead a patient group to advise throughout the programme. Ethical implications There are few serious ethical implications. Resource justification The linking of resources for the workpackages presents an efficient proposal which can deliver more than the sum of each constituent part separately. The main costs are staff related to enable data collection for each workpackage.

Lay abstract: Chronic obstructive pulmonary disease (COPD) is an increasingly important chronic disease of the lungs, affecting 5-10% of the population worldwide and accounting for 1.4m GP consultations and 1m hospital bed-days per year in the UK. There are also around 24 million working days lost each year attributable to COPD. However, up to 85% of cases remain undiagnosed in the community, meaning these people may not get early treatment. There is much uncertainty about how to best identify these missing patients, how COPD progresses, what factors that could be modified (other than smoking) affect the outcomes, and what options for treatment and management are effective in people with milder disease. This programme grant aims to recruit a large group of COPD patients from primary care who have the full range of disease severity (not just those with more severe disease as in other comparable studies). This will allow researchers to assess (within this programme and in future) new ways to treat and manage people with COPD, including those with early disease, as well as understanding more about their condition and how it develops over time. Specifically within this programme we plan to: 1. Test which of two methods is best for identifying people with undiagnosed COPD who may benefit from early treatment 2. Design a better, simple and easily applicable tool to help grade the severity of people’s COPD, allowing doctors to make more appropriate management decisions with their patients 3. Describe and understand more about the way in which COPD affects people’s ability to maintain a job and to work effectively 4. Explore the use of occupational health assessments to improve patients’ ability to remain in work 5. Explore the possibility of introducing an exercise programme to improve the health of people with milder COPD. Patients will benefit because their COPD will be recognised earlier and treatment options will be available to them. Better treatment decisions will be possible (therefore potentially improving their quality of life and survival) as a result of both the new severity score and the possibility of two new interventions in the future (exercise and occupational assessment). They may also be able to return to, or remain longer in productive work. The health service will also benefit by identifying a cost-effective way to identify new COPD patients, treat them and avert future costs. Society will benefit by improving the productivity of COPD patients

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;7.1 INDIVIDUAL CARE NEEDS
Health categories: RESPIRATORY