Electronic monitoring devices: necessary steps for their successful integration with current asthma care

Health monitoring devices are changing the way we treat, manage and understand chronic health conditions by continuously collecting data about medication use, symptoms, vital signs and a patient’s surrounding environment. Asthma is the most common chronic condition worldwide and has symptoms that include wheezing, coughing and shortness of breath - all typically treated with inhaled medication. By taking a daily ‘preventer’ inhaler a patient should be able to control their asthma and remain relatively symptom free. However, adherence to preventer medication is often poor, making patients prone to severe symptoms and asthma attacks. This leads to avoidable healthcare costs, mainly through preventable hospitalisations and wasted medication. Electronic monitoring devices (EMDs) are the most accurate method currently available for recording inhaler use. Through rigorous testing they have been shown to be sufficiently accurate and reliable for use in clinical practise. Early signs also suggest that they may improve inhaler use when a ringtone is used to remind the patient when a new dose is due. However, no research to date has considered the attitudes of patients with asthma as well as healthcare providers towards these devices. Human factors in healthcare is a now established area of research, with an international standard (ISO 62366) meaning that medical device developers are required to design for a usable and error-free experience. This creates clear scope for assessing the perceptions of patients and healthcare providers towards EMDs for use in the management of asthma. This was investigated in this thesis using three separate but related research studies. Two studies assessed the attitudes of patients and healthy volunteers, whilst the other analysed the opinions of healthcare providers and stakeholders in asthma care. The first study assessed the attitudes of a sample of adolescents with asthma towards an exemplar EMD – the SmartTrack. Asthma is most prevalent in adolescents, adherence is notoriously poor, and they are often overlooked in medical device design - making assessing their views a priority. The participants used a SmartTrack device for one month and completed questionnaires and interviews on their opinions towards important issues including being monitored and the device’s appearance, social acceptability and practicality. For the second study, a Delphi survey method was used to collect the opinions of stakeholders in asthma care including respiratory consultants, nurses and GPs towards EMDs. They were asked to state the key benefits they thought these devices could have, as well as the key potential costs and barriers for their introduction. Additional rounds of surveys were then used to assess which points they felt were most important and should be prioritised in the future development of these devices. EMDs developed new capabilities over the course of this thesis, meaning that the third study was used to investigate attitudes towards location and activity data, as both were beginning to be integrated with data on inhaler use. Two workshops and a technology trial were conducted with a sample of healthy adolescents from a local sixth form. Participants had their location and activity tracked and then had this data presented back to them. They were asked for their opinions on the usefulness of this data, as well as any potential risks associated with recording it. The findings from all three studies were then brought together to determine the requirements of EMDs going forward. A systems model of asthma care was developed to firstly consider the routes through which EMDs could be purchased, as well as the impacts EMDs could have on various points of the asthma care process, both for the patient and the healthcare provider. The requirements for EMDs were then also related back to this model, to help outline their importance and relevance to the asthma care pathway. From the research it was determined that developers need to reduce the size of EMDs, as well as integrate the ability to monitor inhalation and technique. Commissioners need to work with clinical researchers to identify the types of patients who would benefit most from an EMD, in order to reduce risks of over- purchasing. Furthermore, researchers need to work with healthcare standards bodies to establish how the vast quantities of data produced by EMDs can be successfully integrated into the clinical care process. This thesis has three key contributions. Firstly, it introduces human factors research methods to the domain of EMDs for asthma care. Secondly, it provides a set of requirements for EMDs to help ensure that these devices can be successfully introduced and used in clinical care. Lastly, it supplements the literature on human factors methods being applied to healthcare and provides a new example of where user-focused research has been used to elicit requirements for a medical device