Implementation of COPD Case Finding and Self-Management Action Plans in Low and Middle Income Countries

Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease resulting when a susceptible individual is exposed to sufficient environmental stimulus (typically cigarette smoke, and/or biomass fuel smoke). More than 90% of COPD-related deaths occur in LMICs, and over the next 15 years COPD is expected to be the leading cause of death globally. LMICs face unique challenges in managing COPD including deficient primary care systems which present challenges with diagnosis and management, especially at the time of exacerbation. Formal diagnosis requires specialised testing with a breathing test (spirometry), which is often limited to urban health centres, while the vast burden of people affected with COPD may live in rural areas. Similarly, treatment options for COPD remain limited where lack of diagnostic testing delays diagnoses and health providers are inexperienced with treating COPD and COPD exacerbations. For the benefit of global health, a revolution in the diagnosis and management of COPD in LMIC is an urgent priority.

In response to the challenges of diagnosing COPD and a renewed global effort to confront tuberculosis, the WHO developed the Practical Approach to Lung Health (PAL). While efforts have been made to improve the diagnosis and differentiation of respiratory illnesses in LMICs, effective community screening with subsequent management strategies have not been successful. Thus, despite these efforts, chronic management of COPD remains limited among LMICs. A key aim of COPD management is to prevent exacerbations. For future efforts to be successful, they need to be combined with robust case finding mechanisms (to better target scarce spirometry resources) as well as effective treatment strategies which are simple and easily applied in resource-limited community health-care settings.

Community-based case finding and self-management are usual care for patients with COPD in developed settings. While a number of COPD pre-screening questionnaires have been developed, many of these are too cumbersome in the number and type of questions assessed to be successfully implemented in LMIC, and they have been developed for tobacco-associated (not biomass) COPD. Simple questionnaires, with a limited number of items, have recently proved successful among populations in the United States. The Lung Function Questionnaire, which assesses five items (age, smoking history, wheeze, dyspnoea and phlegm) has a high predictive value for diagnosing COPD when applied in a US based sample. We plan to assess implementation of a modified, locally relevant Lung Function Questionnaire in three LMICs. Efforts to simplify COPD management have similarly shown success. Action Plans support people with known COPD to recognise and react appropriately to an exacerbation of their symptoms by making changes to their medication including starting courses of antibiotics or steroids with additional salbutamol. COPD Action Plans for self-management currently implemented in both Europe and the US have been shown to decrease the impact of exacerbations on quality of life, increase appropriate use of treatments and hasten recovery time. Action Plans empower people living with COPD to better manage their own lungs, in collaboration with local health-care practitioners. We plan to assess the implementation of case finding with modified Action Plans for COPD management in three LMIC.

Thus, this study aims to modify and assess the usefulness of a currently utilised COPD case finding questionnaire and COPD Action Plans to allow for simple, low-cost models of care which can be generalised across LMICs. We intend to study patients with COPD in Peru, Nepal and Uganda, thereby allowing for inclusion of three distinct middle income and low-income regions. We believe the study will lead to validated and cost-effective diagnosis and treatment packages which can be implemented by national ministries of health and non-governmental organisations globally.

We will (1) assess the utility of a simple questionnaire to better target scarce spirometry resources thus enabling the diagnosis of COPD to be made more easily and cost-effectively, and (2) examine the feasibility of implementing supported self-management Action Plan algorithms for respiratory exacerbations in people living with COPD across three low and middle income countries (LMIC) not on regular therapy. To achieve these aims we will enrol a community sample of 10,500 adults over the age of 40 at urban and rural sites in Nepal, Peru and Uganda where we have ongoing COPD investigations. We will apply a modified 5-item questionnaire which has been validated in the US and compare scores to spirometry, which will be conducted in the field according to the ATS/ERS standards using Easy-on-PC spirometers. Assuming the prevalence of COPD is 9% in Nepal, 10% in Peru and 16% in Uganda we expect a sample of 315, 350 and 560 patients to be diagnosed with COPD in each respective country. A sub-set of those that have confirmed COPD in each country will then be randomly assigned to an intervention group versus standard of care, with COPD Action Plans implemented among the intervention group. We will modify the Living with COPD and the American Lung Association COPD Action Plan which has been validated among those with COPD to act as a guide for supported self-management of exacerbations. Community health workers will be instructed on how to utilise the Action Plan in chronic disease management of COPD as well as manage exacerbations. We will measure quality of life with the EuroQol (EQ-5D) and St. George's Respiratory Questionnaire (SGRQ) every 3 months over a period of one year. The primary end point is SGRQ at 12 months. Results of the EQ-5D will be used to calculate QALYs that will inform an analysis of the cost effectiveness and equity impacts of implementation. We will additionally assess the acceptability and feasibility of implementation in each setting.

Full detail of the impact associated with our studies is provided in the attached Pathways to Impact document.

The primary impact from this research will be experienced by individuals living with COPD in LMICs, as the proposed study will improve both diagnosis and treatment, and assess whether these interventions are cost-effective and scalable when integrated with WHO PAL. Research in developed settings has demonstrated that early diagnosis and better management improve quality of life in COPD, reducing symptoms, maintaining functional status and therefore activity and productivity, slowing the decline of lung function and preventing mortality. Despite overwhelming evidence of the benefits of early diagnosis and management and a significant global burden of disease, global adoption of case finding and treatment methods for COPD remains limited. Our proposal aims to explore the predictive ability of questionnaires to case find in COPD and assess the implementation of Action Plans to manage disease at the primary care level. This will directly improve the medical care of participants enrolled in the study, and by proxy, the wider communities at the partner sites.

The academic beneficiaries, and the communications plan to achieve this impact - high-impact peer-review publications and presentations at scientific meetings across disciplines, guidelines, reports and social media - have been described elsewhere in the application.

The greatest impact arises from the broad implications for policy makers that will result from our studies. By including cost effectiveness analysis on the implementation of case finding and Action Plan management, we aim to inform decisions around COPD interventions made by global health organisations and ministries of health. Our results will improve understanding of the feasibility and scalability of chronic lung disease interventions in LMIC, and help inform global strategies for COPD diagnosis and management.