Dr R. G. English The University of Cape Town Lung Institute George Street Mowbray 7700 Cape Town South Africa
Background: Efforts to improve the care of patients with asthma and allergic conditions is in some developing countries being overwhelmed by the burden of tuberculosis, HIV/AIDS and other infectious diseases. Innovative approaches are required to ensure that these diseases are not neglected.
Methods: The Practical Approach to Lung Health in South Africa is an example of a syndromic integrated algorithm-based diagnostic and management tool for priority chronic respiratory diseases and tuberculosis. It was developed for the needs of nurse care practitioners in poorly-resourced and predominantly rural clinics and includes allergic diseases and asthma. Its diagnostic accuracy and effectiveness at improving the care offered to patients with asthma and rhinitis has been confirmed in two large studies performed in primary care clinics.
Discussion and conclusion: An integrated approach to the management of allergic diseases alongside other priority lung diseases may hold the key to ensuring that the needs of patients with these diseases gain and maintain recognition, and that health resources are appropriately allocated in developing countries.
The prevalence of allergic conditions has been increasing steadily over the past few decades in both developed and developing countries (1, 2). Globally, about 300 million people have asthma, of which 50 million are in Africa (1). Although deaths from asthma have declined in many countries over the past two decades, asthma still accounts for an estimated 180 000 deaths each year, most of which could be prevented with appropriate controller treatment. The pathophysiological link between asthma and allergic rhinitis is well described (3, 4), and allergic rhinitis has been identified as a risk factor for developing asthma (5). It is also said to have a significant effect upon morbidity and the cost of managing asthma (6–8).
The standard of care offered to patients with respiratory diseases, and to those with asthma and rhinitis in particular, varies widely across the world. For example, a comparison of patterns of medication use for allergic rhinitis in European and Asian-Pacific regions suggested better prescribing practices in the western countries (6). Furthermore, in many developing countries programmes for the management of respiratory diseases are poorly developed or limited, and the quality of care offered is often of a low standard (9). Common problems are underdiagnosis and misdiagnosis [particularly of asthma, chronic obstructive pulmonary disease (COPD) and tuberculosis] (10, 11) leading to inappropriate reliance upon antibiotics and underuse of inhaled corticosteroids in asthma (12). Some countries have been slow to implement evidence-based guideline recommendations (13, 14), or have not been successful in convincing practitioners to embrace good practice. Accessibility to care and availability of essential drugs remain important obstacles to improving care in many countries. These problems could be better addressed if the status of chronic respiratory diseases and allergy were improved to that of a public health priority (15). However, even where political will is supportive, additional strategies are required to improve the quality of care offered to patients with these diseases.
Syndromic integrated clinical practice guidelines
Clinical practice guidelines have been shown to improve medical practice and disease outcomes (16). By standardizing diagnostic and management approaches, they reduce practice variation, and reduce the gap between evidence-based recommendations and clinicians’ practice (17). Until recently, with the exception of the Allergic Rhinitis in Asthma (ARIA) guideline, most respiratory guidelines have focused upon one disease. The ARIA guideline acknowledges the importance of the association of asthma with allergic rhinitis and has adopted an integrated approach to the management of these two conditions (3). The use of an integrated syndromic approach to the management of diseases in primary care has been proposed for some time. This approach has been successfully applied in the Integrated Management of Childhood Illness (IMCI) (18) model in children and for the management of sexually-transmitted infections (STIs) in adults (19). It has also recently been proposed for the management of chronic respiratory diseases by the World Health Organization (20, 21), and for the management of chronic obstructive airways diseases by the International Primary Care Respiratory Group (22, 23).
The World Health Organization-led strategy known as the Practical Approach to Lung Health (PAL) was developed with the purpose of improving the quality of care offered to patients with chronic respiratory diseases while at the same time improving tuberculosis case detection. Another objective of PAL programmes in developing countries is to achieve a higher priority for respiratory diseases within health services (24). Typically, in these countries health services planning is dominated by the need to address the more urgent public health needs, such as tuberculosis, HIV/AIDS, and respiratory tract infections, and little or no provision is made for other chronic respiratory diseases. Thus, symptomatic patients who are shown on screening not to have tuberculosis or HIV/AIDS may receive an antibiotic or other short-term symptomatic treatment, and then be discharged without the consideration of a possible underlying chronic disease. Reasons for this include the difficulty in making accurate diagnoses in resource-poor settings and lack of provision of drugs for managing chronic disease. The PAL approach provides a framework for both diagnosis and management within the limitations of local resources, but in order to be relevant and effective it needs to be adapted to local conditions.
The Practical Approach to Lung Health in South Africa
The Practical Approach to Lung Health in South Africa (PALSA) is an adaptation of PAL for the needs of a country with high burdens of tuberculosis and HIV/AIDS. The first component of the PALSA intervention is a generic symptom and sign-based (syndromic) guideline for nurses in primary care which contain algorithms that integrate the diagnostic approach to common respiratory diseases in patients 15 years and older (25–27). The other components of PALSA are an in-service training model (educational outreach) for primary care nurses, and a programme of ongoing evaluation of the effectiveness of the intervention. The PALSA guideline may be viewed on the web at http://www.biomedcentral.com/content/supplementary/1471-2466-6-22-S1.pdf. The educational outreach training model differs from the usual PAL model by directing the intervention to nurse practitioners because in South Africa, as in many countries with limited health resources, a shortage of doctors, particularly in rural clinics is a significant obstacle to improving services; and secondly, because nurses in this setting are familiar with syndromic diagnostic guidelines (IMCI and STIs) and play a leading role in the tuberculosis control programme. Moreover, in focus groups held during the development of the PALSA guideline, nurse practitioners frequently expressed frustration at not being permitted to, nor having the expertise, to offer further treatment to symptomatic patients who were found not to have tuberculosis.
In developing PALSA, major challenges were to develop a syndromic diagnostic algorithm that did not require lung function testing or screening tests for atopy, and secondly to address the problems of erratic drug supply and restrictive regulations to prescribing by nurses. In most guidelines, lung function assessment is considered an important, if not central component in the diagnosis of asthma and in distinguishing asthma from COPD. However, in extensive discussions with managers and clinicians it became clear that it was highly unlikely that spirometry could be made available in even a minority of clinics or that suitable personnel could be identified to perform the tests. Previous attempts to introduce spirometry in such clinics had shown that although nurses could be trained to perform spirometry, objections to doing so were the large number of other tasks that they were required to do, difficulty interpreting and applying the results, absence of quality control and lack of conviction that spirometry added much to the clinical management of patients with respiratory diseases. Invariably, as has been shown in other primary care settings, staff lost enthusiasm for the investigation and it ceased to be used (28, 29). Skin and serological testing for atopy are also not available at this level and opportunities for referring all patients to the next level of care where such tests might be available are limited.
Prescribing for asthma and rhinitis in primary care clinics is governed by the schedules prescribed in the National Essential Drugs List (30). In primary care, asthma treatment is limited to inhaled short-acting beta-agonists and beclomethasone or budesonide (maximum of 800 μg/day). For allergic rhinitis, it is limited to chlorpheniramine and intranasal steroids. Although the majority of services for primary care are provided by nurses, current prescribing provisions do not permit them to initiate corticosteroids and intranasal steroids, or to prescribed oral steroids for acute exacerbations. Common practice issues are that when inhaled corticosteroid medications are not readily available because of availability or distribution problems, health workers tend to resort to prescribing oral medications. In addition, some managers consider the unit cost of inhaled corticosteroids too high, and also favour oral treatment. However, this is a false economy as the cost of oral theophylline is now considerably higher than that of the generic inhaled corticosteroids. Furthermore, use of long-acting beta-agonist prescription is restricted to higher levels of care (specialist clinics), and combination therapy is not available within the public healthcare sector.
The PALSA guideline was, therefore, ‘tailored’ to the local context using accepted guideline development methodologies (31–33), theories of changing professional practice (34), and evidence showing that guidelines which take local settings into account are more likely to effect change (35). It was also required to be compatible with the policy frameworks for human and physical resources at primary care, which are well established in South Africa. The guideline development steps included formation of a multidisciplinary group; review of local policies, practices, international and national guidelines, and scientific evidence; assessment of local barriers to care using qualitative research; and review and feedback on the PAL and draft versions of the PALSA guidelines. For obstructive airways disease conditions, relevant local guidelines and others such as those produced by GINA (36), GOLD (37), ARIA (4), and the IUATLD (38) were primary references. Respiratory disease questionnaires and studies reporting on the accuracy of clinical items to predict respiratory disease were also reviewed.
When the PALSA guideline was developed, it differed in two respects from international guideline recommendations for the management of asthma. Firstly, diagnosis was syndromic, and secondly, in order to simplify assessment, it was not classified by severity. Instead, it contained simple definitions of firstly, uncontrolled asthma and another for acceptable control, and clinicians were set the goal of achieving and maintaining control as close to the latter as possible. This approach has subsequently been accepted and incorporated into national and international asthma guidelines (39). An outline of the algorithm for diagnosing asthma is presented in Fig. 1. The entry questions related to the presence of difficult breathing (dyspnoea, wheezing, tight chest) and/or cough, and the next relates to duration of symptoms. A cut-off of 2 weeks separates acute respiratory conditions such as exacerbations of obstructive lung disease and respiratory tract infections from chronic diseases (e.g. TB, asthma and COPD). Secondly, patients with symptoms for less than 2 weeks who report wheezing or tight chest are treated as acute deterioration or exacerbations of asthma or COPD without attempting to distinguish which is the correct diagnosis. Thirdly, a section is dedicated to the syndromic diagnosis of asthma and COPD on the basis of symptoms and signs (Fig. 1). However, in all patients the diagnosis is reviewed within 1 month in a visit to a clinic physician (at the same or a referral centre). Finally, the long-term management of asthma (using a stepped approach) is based on levels of asthma control rather than on an assessment of disease severity. The diagnosis of rhinitis is considered if a runny/blocked nose, sneezing or itching is reported. Symptoms for less or more than 4 days per week separates the presentation into intermittent or persistent disease, respectively.
A feature of a guideline of this nature is that it undergoes continual revision in order to ensure that it is relevant to each region in which it is implemented and to accommodate changes in diagnostic procedures and changing treatment recommendations. For example, the latest version integrates the approach to asthma and allergic rhinitis in keeping with ARIA recommendations. Although to clinicians these short-cuts to diagnosis and trial of therapy approaches appear crude, use of the guideline and its performance has been validated in two large studies undertaken in primary care clinics in different provinces of South Africa. The first assessed the accuracy of the PALSA guideline to make respiratory diagnoses by comparing the diagnostic performance of a nurse using the guideline to that of a blinded specialist respiratory physician with access to special investigations. Its performance in improving screening for tuberculosis has been reported (25). Results for the diagnosis of asthma and COPD are also encouraging (RE, unpublished data) and will be reported shortly. The second study was a pragmatic randomized controlled effectiveness trial in rural clinics in the Free State Province of South Africa, and is described below.
Guideline implementation in developing countries
Locally adapted integrated respiratory case management guidelines provide an important starting point, but alone are unlikely to result in improved quality of care for allergic conditions. In response to the slow uptake of research findings in practice, health systems researchers in the developed world have spent the last two decades evaluating the relative effectiveness of guideline implementation strategies. These strategies have been described and categorized by the Cochrane Group on the Effective Practice and Organization of Healthcare (40), and include among others, the passive dissemination of educational materials including guidelines, reminders, educational outreach visits, and audit and feedback. Their relative effectiveness has been tested in rigorous implementation trials, and numerous examples have been applied to allergic conditions with varying success (41–43). However, seldom have the lessons learned been applied in the developing world where health services tend to rely on centralized didactic training courses of unknown effectiveness.
In the late 1990s AfroImplement, a European Union funded concerted action project, promoted the uptake of research findings in sub-Saharan Africa through the development and testing of implementation strategies. One of its first trials involved the use of educational outreach, or noncommercial short face-to-face interactive education by a trusted outsider, on the management of childhood asthma to general practitioners in a large socio-economically deprived suburb of Cape Town (44). A year later children attending intervention group practitioners were noted to have reduced asthma symptoms compared with those attending control group practitioners.
Educational outreach had previously been identified as a promising strategy for changing the behaviour of physicians towards evidence-based choices in developed countries (45). However, a methodologically sophisticated meta-analysis of guideline implementation strategies published in 2004 suggested that it might not be as effective as previously thought (46). Nonetheless it remains an attractive choice for developing world settings because, unlike reminders or audit and feedback, it is not dependent on functioning information systems which are often poorly developed or absent.
Implementation of PALSA
In 2003, educational outreach was used to implement PALSA in nurse–practitioner staffed clinics of a rural province of South Africa characterized by high burdens of HIV and tuberculosis. The on-site nature of the intervention offered further advantages in this setting: minimal disruption to already understaffed clinics, and an opportunity to simultaneously expose all clinic staff to training. Participation in centralized offsite training courses usually means that only one health care worker from any one clinic can attend at a time. Consequently coverage is limited and this undermines the potential of training interventions to impact on population health. Through PALSA, district tuberculosis care co-ordinators were trained as outreach trainers and asked to deliver the PALSA intervention to nurses working in 20 busy clinics. Nurses trained in PALSA were also permitted to initiate inhaled corticosteroids in asthmatic patients provided they were reviewed by a doctor within 1 month. The 20 clinics formed the intervention arm of a pragmatic cluster randomized controlled trial evaluating the effect of PALSA on the quality of care delivered to patients with respiratory symptoms (26). The trial showed that despite limited exposure to the intervention, PALSA improved the quality of asthma and tuberculosis care. Inhaled corticosteroid prescription nearly doubled among patients attending intervention clinics. Also, prescriptions appeared to be clinically as appropriate: significantly more inhaled corticosteroid recipients in the intervention group reported responsiveness to beta-agonists than their control group counterparts suggesting that the treated disease was indeed asthma. This trial goes some way to demonstrating that, given effective training and access to essential drugs, nonphysicians can provide high quality care to patients with allergic conditions.
Opportunities for promoting care for asthma and allergies in high burden infectious disease countries
In sub-Saharan Africa the recent explosion in the tuberculosis epidemic has evoked responses which are vertical and selective like the World Health Organization's declaration of tuberculosis as a global emergency (47). Amid these responses little attention is paid to horizontal programmes which favour medium to long-term service strengthening and sustainability (48). Instead vertical programmes, frequently donor funded, which promise large and immediate gains are prioritized. Globally, PAL is slipping on the health care agenda, as tuberculosis and AIDS take centre stage amid initiatives such as the Global Fund for AIDS, Tuberculosis and Malaria, and the ‘3 by 5’ campaign. Ironically, it is the ‘skilling-up’ of frontline multipurpose health workers, as achieved through programmes like PALSA, that is required to ensure that Millennium Development Goals for priority diseases like tuberculosis and AIDS will be met (49).
The introduction of antiretroviral treatment programmes has revitalized health workers and created a receptive context into which to deliver interventions to change practice (50). PALSA has attempted to capitalize on the momentum provided by antiretroviral treatment programmes by expanding to cover the management of HIV/AIDS including antiretroviral treatment. The revised package, called PALSA PLUS, is being widely implemented in primary care facilities across two provinces in South Africa. The allergic disease components have been retained and are addressed alongside the more common infectious diseases. Given the large numbers of those with HIV and tuberculosis who present with respiratory symptoms, it is appropriate that asthma remain visible as an alternative diagnosis. Qualitative research alongside PALSA PLUS implementation in the Free State province suggests that the uptake of the respiratory components of the guideline far exceeds that obtained with PALSA. A randomized controlled trial in another South African province is evaluating its effect on inhaled corticosteroid provision alongside HIV and tuberculosis indicators. In South Africa, which is undergoing epidemiological transition, conditions such as TB and HIV/AIDS, tend to eclipse the contribution made by allergic conditions to the overall burden of respiratory disease. Integrated care guidelines provide an important tool for keeping allergic conditions on the agenda in this setting, and may even be able to capitalize on the health sector reforms accompanying large-scale implementation of antiretroviral treatment programmes.
PALSA provides a model for integrated syndromic care in primary care settings. The advantage of the PALSA guideline is that in addition to aiming to increase the case detection of TB, it provides a diagnostic approach to comorbid respiratory conditions and/or symptomatic patients who do not have tuberculosis. Given effective training and access to essential drugs it is possible for nonphysicians to treat allergic conditions effectively in resource-restricted settings.