P. McCormack

Open adherence monitoring using routine data download from an adaptive aerosol delivery nebuliser in children with cystic fibrosis

BACKGROUND Adaptive aerosol delivery (AAD) nebuliser devices can reduce treatment times whilst enabling adherence to be monitored using inbuilt data logs. Using one such device, we have monitored nebulised antibiotic adherence in children with Cystic Fibrosis (CF). METHODS In CF children infected with Pseudomonas aeruginosa, downloaded data from an AAD device was used to calculate morning, evening and overall monthly adherence to antibiotic therapy over a year. RESULTS Overall monthly adherence to nebulised antibiotic therapy in 28 children was maintained between 60 and 70% over the year. Considerable variation in adherence, both between and within patients, was evident (Mean [SD] coefficient of variation, 37[44]%). Evening adherence (75[37]%) was better than morning adherence (58[34]%: p=0.012). Treatment regimens were changed in 8/28 patients based on adherence data. CONCLUSIONS Routine adherence monitoring can be implemented in an outpatient setting. Using this type of information it is possible to identify which aspects of treatment can be improved and to work together with families to individualize treatments.

Adherence to nebulised therapies in adolescents with cystic fibrosis is best on week-days during school term-time

OBJECTIVES Treatment regimen for families of children with cystic fibrosis (CF) is considerable, particularly when nebulised therapies for chronic Pseudomonas aeruginosa airway infection are prescribed. Adherence to these regimens is variable, particularly in adolescence. Previously, we reported children to be more adherent in evenings compared to mornings, suggesting an association with time-pressure. The aim of this study was to determine whether adherence would be better in adolescent patients at weekends and during school holidays when time-pressures may be less. STUDY DESIGN 24 patients (14 male, median [range] age 13.9 [11.1-16.8] years) were enrolled from two regional paediatric CF centres in the United Kingdom. Data for a full scholastic year, were downloaded openly from a breath-activated data logging nebuliser (I-neb™). Adherence (% of doses taken÷expected number) was calculated during term-times, holidays, weekends and weekdays, for each patient. RESULTS Large variations in adherence were seen between patients. However, adherence during term-time was significantly better than holidays (p<0.001). Weekday adherence was better than weekend adherence in term-time but not holidays. Interestingly, patients prescribed three daily treatments took on average 1.4 treatments/day, a similar number to those prescribed two daily treatments. CONCLUSION Overall adherence to inhaled therapies was reasonable, but significantly reduced during holiday periods. This suggests a need for families to have not only time, but also structure in their daily routine to maintain optimal adherence to long-term therapies. It is important for CF teams to appreciate these factors when supporting families.

A randomised controlled trial of breathing modes for adaptive aerosol delivery in children with cystic fibrosis

BACKGROUND Aerosol delivery is a cornerstone of CF airways disease management. New nebulisers have reduced treatment times by utilising mesh technology for aerosol production. We have evaluated a further modification (target inhalation mode (TIM)) that may reduce treatment delivery times further. METHODS Following a baseline period on tidal breathing mode (TBM), children with CF on long-term aerosol therapy were randomly allocated to either TIM, which optimises patient inhalations through a direct feedback mechanism, or to continue TBM. The primary outcome was nebuliser treatment times with secondary outcomes being adherence and patient preference. RESULTS The ten children allocated TIM reduced their mean (SD) treatment times from 6.9(2.9) to 3.7(2.3) minutes (p<0.001). In contrast, treatment times were unchanged in the ten children allocated TBM. Mean adherence was maintained in the TIM group but declined in patients allocated TBM by >5%. All children preferred TIM to TBM. CONCLUSION TIM reduces nebuliser treatment times and may positively impact on adherence, although longer duration studies are required to examine this. (ISRCTN65617839).

New nebulizer technology to monitor adherence and nebulizer performance in cystic fibrosis.

Topical delivery of aerosolized therapies is an established treatment for chronic airway infection and inflammation in cystic fibrosis (CF). Recent developments in nebuliser technology have enabled Adaptive Aerosol Delivery (AAD) of mesh generated aerosol particles resulting in more efficient airway deposition than existing jet nebulizers. An additional feature of these new devices is the ability to record and examine the performance of the device by downloading stored data (electronic data capture). In a series of studies we have used this downloading facility to monitor treatment times and examine adherence to nebulizer therapy in our pediatric patients. We found routine adherence monitoring is possible in busy CF clinic. We have shown that good adherence to treatment can be maintained in both patients chronically infected with Pseudomonas aeruginosa on long-term therapy, and in patients with first/new growths of Pseudomonas on short-term eradication therapy. When adherence was examined from an individual perspective, we demonstrated a wide variation both between and within individual patients. A further modification of AAD technology, Target Inhalation Mode (TIM) optimises patient inhalations through a direct feedback mechanism. This new breathing mode has also been evaluated in our pediatric CF clinic in a recent randomized controlled trial (RCT) and we have shown that children maintain adherence to treatment through the TIM mouthpiece and average treatment times reduced from 6.9 to 3.7 min when using TIM. This is a new era of aerosol delivery and novel advances in medical devices need to be monitored and assessed rigorously, particularly as new and potentially expensive therapies emerge from translational studies. Electronic data capture enables CF teams to work in an open partnership with patients to achieve the common goals of improving drug delivery and reducing patient burden.

After a long wait, two arrive, one after the other!

Cystic fibrosis (CF) airways disease is unique, with chronic infection causing a localised but intense inflammatory process, acute in nature, but lasting for years.1 Prevention, eradication and suppression of airway infection have been the cornerstones of CF management, and success with these strategies has been a key factor in improving the outlook for people with CF.2 An armamentarium is available to achieve this goal, including a variety of aerosolised therapies. The evidence base to support these therapies ranges from good to poor.3 ,4 Individual patients respond uniquely, with therapeutic strategies working for some but not for others. It is complicated, and a team approach (including the patient) is essential to deliver the best regimen for each individual. What we do know with some certainty is that an aerosolised therapy does not work if it stays in the box or at the pharmacy. Sustaining time-consuming treatments is a difficult challenge for people with CF. Recent innovations in aerosol delivery have provided some help. Devices that generate aerosol through mesh technology have reduced treatment times and improved deposition.5 ,6 Some devices, by monitoring inspiratory and expiratory flow, provide a pulsed delivery that synchronises with the respiratory cycle to optimise lower airway deposition.7 In a randomised controlled trial, we were able to show that the addition of a simple manoeuvre to guide breathing with such a device (a vibration at the end of inspiration) reduced treatment times to 3–4 min.8 Reduction in treatment time was associated with maintenance of adherence, which faltered in the control group. A feature of these new types of adaptive aerosol delivery devices is that data can be downloaded that record the performance of the device.9 Electronic data …

A formative study exploring perceptions of physical activity and physical activity monitoring among children and young people with cystic fibrosis and health care professionals

BackgroundPhysical activity (PA) is associated with reduced hospitalisations and maintenance of lung function in patients with Cystic Fibrosis (CF). PA is therefore recommended as part of standard care. Despite this, there is no consensus for monitoring of PA and little is known about perceptions of PA monitoring among children and young people with CF. Therefore, the research aimed to explore patients’ perceptions of PA and the acceptability of using PA monitoring devices with children and young people with CF.MethodsAn action research approach was utilised, whereby findings from earlier research phases informed subsequent phases. Four phases were utilised, including patient interviews, PA monitoring, follow-up patient interviews and health care professional (HCP) interviews. Subsequently, an expert panel discussed the study to develop recommendations for practice and future research.ResultsFindings suggest that experiences of PA in children and young people with CF are largely comparable to their non-CF peers, with individuals engaging in a variety of activities. CF was not perceived as a barrier per se, although participants acknowledged that they could be limited by their symptoms. Maintenance of health emerged as a key facilitator, in some cases PA offered patients the opportunity to ‘normalise’ their condition.Participants reported enjoying wearing the monitoring devices and had good compliance. Wrist-worn devices and devices providing feedback were preferred. HCPs recognised the potential benefits of the devices in clinical practice.Recommendations based on these findings are that interventions to promote PA in children and young people with CF should be individualised and involve families to promote PA as part of an active lifestyle. Patients should receive support alongside the PA data obtained from monitoring devices.ConclusionsPA monitoring devices appear to be an acceptable method for objective assessment of PA among children and young people with CF and their clinicians. Wrist-worn devices, which are unobtrusive and can display feedback, were perceived as most acceptable. By understanding the factors impacting PA, CF health professionals will be better placed to support patients and improve health outcomes.

346 A qualitative study to explore factors that impact adherence to aerosol therapy in young people with CF: Patient and parent perspectives

346 A qualitative study to explore factors that impact adherence to aerosol therapy in young people with CF: Patient and parent perspectives D. O’Toole1, G. Latchford1,2,3, A. Duff3,4, R. Ball4, P. McCormack5, P.S. McNamara5, K.W. Southern5, K.G. Brownlee4. 1University of Leeds, Leeds Institute of Health Sciences, Leeds, United Kingdom; 2Leeds Teaching Hospitals NHS Trust, Adult Regional CF Centre, Leeds, United Kingdom; 3Leeds Teaching Hospitals NHS Trust, Department of Clinical and Health Psychology, Leeds, United Kingdom; 4Leeds Teaching Hospitals NHS Trust, Paediatric Regional CF Centre, Leeds, United Kingdom; 5University of Liverpool, Department for Women’s and Children’s Health, Liverpool, United Kingdom