The NICE guideline on asthma (NG80) recommends that spirometry, bronchodilator reversibility, and fraction of exhaled nitric oxide (FeNO) testing should be available to support asthma diagnosis across all care settings, and spirometry monitored at each asthma review in children aged five years and over.
CHAMPIONS was a prospective study designed to evaluate the resources required to implement routine spirometry and FeNO testing for children in primary care, and to explore their clinical utility in diagnosing and monitoring children’s asthma. The study involved 10 general practices in Leicestershire and Northamptonshire with a combined patient population of over 100,000 people. 1200 children were eligible to take part, and 612 were recruited onto the study. Recruitment took place over 15 months between June 2016 and September 2017.
Aims and objectives
Implementation of the NICE asthma guideline recommendations would represent a major change in the way that childhood asthma is managed in primary care and has understandably raised concerns amongst stakeholders. This is chiefly because there is little UK data relating to lung function and asthma control in children managed in primary care, and limited data exploring clinical outcomes resulting from lung function testing.
We conducted a large prospective observational cohort study to explore the feasibility of implementing spirometry and FeNO testing for children with diagnosed or suspected asthma managed within the community, and to explore the clinical utility of implementing spirometry and FeNO on childhood asthma diagnosis and monitoring in primary care.
The main aims of this study were to evaluate the training and capacity requirements of general practices in order for them to deliver routine spirometry and FeNO testing for children aged 5-16 years, to quantify the prevalence of abnormal lung function, and to explore the relationship between reported asthma control and objective test results.
Reasons for implementing your project
Guideline recommendations promoting the routine use of spirometry in asthma diagnosis and monitoring in children are not new, albeit not stated as explicitly as within the latest NICE guideline. As discussed earlier, the recommendations made within the NICE asthma guideline would represent a significant change in the way children’s asthma is managed in general practice, and has been met with criticism partly fuelled by the lack of pragmatic studies using objective testing in children within the ‘real-world’ GP setting.
In our preliminary work, we identified that lack of time, clinic capacity, and lack of training and expertise were the most commonly cited reasons against the routine use of spirometry and FeNO in UK general practice. For widespread adoption of spirometry and FeNO to take place, the training needs of GP staff, and additional clinic time required for testing needs to be quantified. Importantly, the clinical usefulness and acceptability of providing these tests for asthma diagnosis and management needs to be demonstrated in order to convince GPs to use them in their routine practice.
Ten practices participated in the CHAMPIONS study. Practices were selected to capture populations with different ethnic and socioeconomic demographics, and a mixture of urban and suburban locations. Geographically, five of the practices were located in inner-city Leicester (residents ~330000), two were in village locations (residents 5000-6000), and three were in surrounding towns (residents 50000 to 60000).
How did you implement the project
Potential general practices were contacted directly by the project fellow via phone or email, in addition to being sent a standardised invite letter and information sheet. In total, 17 general practices were contacted and 10 expressed an initial interest to participate.
Face-to-face meetings with the practice manager(s) and clinical staff were arranged with all 10 interested practices to provide a short presentation explaining the project and to answer any queries. All 10 practices agreed to participate following these meetings.
Training was delivered to 27 members of clinical staff across 10 practices. Twelve people already performed spirometry testing in adults, but none had previously had training to perform spirometry in children. No GP staff had any previous experience with FeNO testing.
Children on the GPs asthma register and those who had received asthma medications in the previous 12 months (but not on the register) were invited for an asthma review. Asthma control data (using standardised questionnaires), the number of unplanned healthcare attendances due to asthma, spirometry and FeNO values, and the acceptibility of these tests to staff members and families were recorded in 612 children in whom consent was obtained.
Follow up asthma control questionnaires were sent out, and electronic records were reviewed for number of unplanned healthcare attendances six months following on from the initial review.
The salary costs for the project fellow and nurse were provided by Health Education East Midlands, and the Midlands Asthma and Allergy Research Association. Equipment costs and consumables were provided by Circassia Pharmaceuticals as part of a research grant.
We were able to train 27 members of GP staff (practice nurses and health care assistants) to competently perform and/or interpret spirometry and FeNO in children in an average of 10 hours per trainee. Usable spirometry and FeNO data was achievable in 94% and 77% of children aged five to 16 years respectively. Importantly, following implementation, all GP staff who responded (85%) to the feedback questionnaire felt that providing spirometry in their practice would help them to manage children's asthma better, and 91% felt FeNO would help also. Moreover, 97% of parents reported a positive experience of lung function testing (using a friends and families test), and 87% of children said they would be happy to perform the tests in future reviews.
Of the 612 children participating from 10 general practices, 24% were found to have abnormal spirometry and 36% had raised FeNO (>35ppb). Interestingly, children with poor symptom control and abnormal spirometry had more unplanned healthcare attendances (UHAs) in the six months prior to review compared to children with normal spirometry; 0.58 vs 0.31 (p=0.036) and showed a significant reduction in UHAs following the review. Likewise, follow up asthma control questionnaires were returned by 226 (37%) children, and mean asthma control scores increased in the six months following review also.
Importantly, we also demonstrated that assessing asthma control based on symptoms alone is inadequate to identify children with obstructed airflow or active airway inflammation - 54% of children reporting good asthma control had abnormal spirometry or raised FeNO, whilst 49% of children reporting poor control had normal tests.
Key learning points
It is possible to train GP staff to obtain quality spirometry and FeNO data from most children aged five to sixteen years in the primary care setting, and the tests are acceptable to staff and families. Moreover, abnormal lung function is highly prevalent in children managed in primary care, and a symptoms’ based assessment alone is inadequate to identify those children with obstructed airflow or active airway inflammation. Importantly, obstructed airflow in children with poor asthma control is associated with almost double the mean number of asthma attacks compared to in children with normal spirometry. We believe that this in itself justifies the need for objective tests to be a routine part of children’s asthma management in primary care.
Interestingly, our findings would also suggest that the use of spirometry and eNO to monitor children’s asthma in general practice may reduce the number of exacerbations and improve control; but this is to be interpreted with care as our study was not powered primarily for this outcome.
Looking forward, the one-to-one training package offered as part of CHAMPIONS may not be practicable in the real world setting. Alternative ways to deliver training in children’s spirometry and FeNO testing needs to be explored in order to reduce training costs and to reach a much larger target audience if these tests are to be rolled out nationwide.
It may also be possible to reduce costs and improve efficiency by concentrating expertise within local primary care hubs i.e. providing lung function testing with the results going back to the patients’ own GPs for interpretation and management (asthma diagnostic hubs), or support GPs and practice nurses with specialist interests in asthma to staff these hubs, providing both lung function testing and asthma management reviews at the same time (asthma management hubs). The best model to deliver quality asthma care and the most cost-efficient way to deliver these hubs will need further study.
This study was funded from grants provided by the Midlands Asthma and Allergy Research Association (MAARA) and Circassia Pharmaceuticals - equipment and research nurse costs. The project fellow was funded by Health Education East Midlands.