Discussion
This is the first study to explore the feasibility of four NEMDs for use in children with asthma using both qualitative and quantitative methods.
The key finding was that devices that use objective measures of activation, inhalation and technique which are accurate, require least effort, are easy to use and fit into existing routines of children and carers were preferred by children, their carers and healthcare professionals. Other ideal characteristics include cost-effectiveness as expressed by CNS, flexibility to set up reminders with notifications as suggested by children, and ability to provide visual display of adherence data in real time which was desired by both children and healthcare professionals.
The four platforms were chosen for this study as they use different methodologies to assess inhaler technique. Advantages and disadvantages were identified by participants for each. The Hailie and the INCA were popular with both children and CNS’ due to their ease of use and minimal additional effort required on the part of the child. The Hailie has the ability to detect adherence in real time calculating percentage adherence easily, though this function was not enabled in our study. Furthermore, it provided useful data for healthcare professionals on individual components of inhaler technique. However, both the Hailie and the INCA devices are specific to a single type of inhaler device: the Turbohaler and Accuhaler, respectively. These are both breath-actuated inhalers and require adequate inspiratory flow to use, which younger children may find difficult to generate. Of note, recruitment in the block for the INCA device was low as most children who are prescribed Seretide in our clinic use the MDI version not the Accuhaler. Unfortunately for the INCA block, no usable adherence data were obtained as the devices were thrown away or not fitted correctly. This is in contrast to the study by Sulaiman et al in adults which demonstrated the utility of the device for monitoring inhaler use and technique.19 Many of the advantages identified with the Hailie, such as ease of use, requiring no extra steps are also relevant to the INCA. At the study site, an MDI with a spacer was the most frequently used inhaler type. Unfortunately, there were no devices available at the time of the study which had the usability and functionality of the Haile and INCA, and could also be used with an MDI and spacer.
The Rafi-tone App was designed to help young children improve inhaler technique and to incentivise inhaler use via a game. This was adapted by the developer of the Clin-e-cal App for this study to record adherence. The App is aimed at younger children and therefore we limited recruitment to this block to children aged 6–11 years. Feedback from parents was positive in terms of the impact on technique. However, the current functionality of the App is limited to collecting data when the correct pitch is heard from the Flo-tone. It is not possible to know which inhaler was used, the number of puffs used or if the Flo-tone was even attached to an inhaler. This limits the utility of this platform for monitoring ICS adherence (for which it was not originally designed). Additional effort was required on the part of the parent/caregiver to ensure that the App was open at the time the inhaler was given. Nonetheless based on our study findings, an App for children which incentivises inhaler use, particularly one that rewards good technique, has the potential to be an effective intervention that merits further study and consideration.
The R-DOT platform was the only platform capable of monitoring use for all types of inhaler devices, which is particularly advantageous given the number of different inhaler types now available. It also enables technique to be assessed by a trained professional and ensures that all aspects of inhaler technique are checked. Furthermore, feedback can be given rapidly to correct technique. In our study, it was not possible to review inhaler technique in real time, due to logistical constraints and there was no intervention during the monitoring period. In a pilot study of this device, positive user feedback was reported with improvement in technique over successive weeks of monitoring and intervention.20 In contrast, some of the comments in our study from children reflected concerns about filming themselves. This was particularly the case among adolescents who were concerned about their appearance. Although this platform is excellent for information on technique it provides little definitive information on adherence. Failure to record a video does not necessarily mean that the inhaler has not been used. Parents highlighted the difficulties of fitting this in to a busy routine. It is possible that if this change in routine could be achieved in the short term, it might lead to longer-term behavioural change where correct inhaler use is embedded in the daily routine.2 CNS' felt that this was a good way to assess technique; however, reviewing the videos took time and they do not currently have the capacity to do this outside of a clinical study. Advantages with the R-DOT included the physical evidence that the dose was taken correctly enabling remote offsite monitoring of children with provision of instant feedback.
The main strength of this study is that it is the first time that the INCA, Rafi-tone and Hailie have been used as adherence monitoring tools in a real-world setting in children, and compared using both quantitative and qualitative methods.
The main limitation of this study is the small sample size which did not enable robust quantitative statistical analysis of the data. This study took place within a specialist tertiary asthma clinic and the findings may not be generalisable to the general population of children with asthma, particularly in primary care. Further evaluation of these NEMDs in a wider population is warranted. However, many of the findings are pertinent across care settings, particularly those relating to cost and impact on the workload of healthcare professionals. The acceptability criteria developed from our findings could potentially be used for testing future NEMDs.