Alexandra Lang

Medical device design in context: A model of user–device interaction and consequences

The practice of evaluating interaction with devices is embedded in disciplines such as human–computer interaction and cognitive ergonomics, including concepts such as affordances, error analysis, skill, rule and knowledge based behaviour and decision making biases. This paper considers the way in which the approach that has been routinely applied to displays and control design within the control and transport domains can be transferred to the context of medical devices. The importance of considering the context in which medical devices are used and implemented is presented, and the need for a systems approach to medical device design is emphasised. Five case studies from medical device control and display design are presented as an aide to developing an understanding of the relationship between device design and resultant behaviours. On the basis of these case studies, four types of mediating factors (catalysts, enablers, facilitators and enhancers) are proposed and a model to describe the link between device design, user, context and consequences is presented.

The effect of design on the usability and real world effectiveness of medical devices: a case study with adolescent users.

Adolescents are currently overlooked in many fields of healthcare research and as a result are often required to use medical devices that have been designed for use by either children or adults. This can lead to poor adherence and a reduction in health outcomes. This study examines the role of device design in the real-world effectiveness of a medical device used in the treatment of cystic fibrosis from the perspective of adolescent users. Interactive design interviews were carried out with 20 adolescent users of the acapella(®) physiotherapy device to investigate user requirements and themes about the user-device relationship that are important to this user group. This study found that adolescent users of the acapella(®) device do not use the device as regularly and correctly as is recommended by clinicians. A number of aspects of the current design of the acapella(®) device were identified that affect how and how often it is used. Five factors are identified that may improve the real world effectiveness of the acapella(®) device for adolescents with Cystic Fibrosis: engagement, information, confidence, aesthetics and compatibility with lifestyle.

Electronic Monitoring of Adherence to Inhaled Medication in Asthma

The main treatment of asthma is inhaled corticosteroids. However adherence to these medications in asthma is often poor, with low adherence associated with excessive health care costs and an increased risk of emergency room visits and mortality. Although various methods are used to indirectly assess adherence, all have significant limitations whether used in clinical or research practice. The recent development of electronic monitoring devices (EMDs) for use with inhalers presents an exciting opportunity to easily and accurately measure inhaler adherence. This article summarises the current devices available; for each device features and limitations are considered, followed by a review of both the current clinical literature and data on reliability and accuracy. An overall summary is also provided to aid comparison of capabilities between devices and future issues pertaining to the use of EMDs are discussed, including barriers to adoption, stakeholder involvement, novel methods of communicating adherence data, recording of data and cloud storage. Finally key areas that still require investigation are highlighted.

Medical device design for adolescent adherence and developmental goals: a case study of a cystic fibrosis physiotherapy device.

Purpose This study investigates the psychosocial aspects of adolescent medical device use and the impact on adolescent adherence and goals for the transitional years between child and adulthood. Patients and methods Interviews were carried out with 20 adolescents with cystic fibrosis, investigating adolescent medical device use and experiences in relation to their personal and social lives and development through the adolescent years. The qualitative dataset was thematically examined using a content analysis method. Results The results show that adolescent users of medical technologies want their independence and capabilities to be respected. Adolescent adherence to medical device use was associated with short- and long-term motivations, where older adolescents were able to comprehend the longer-term benefits of use against short-term inconvenience more acutely than younger adolescents. It was suggested that medical devices could provide a tool for communication with families and clinicians and could support adolescents as they take responsibility for managing their condition. Themes of “fitting into teenage life” and “use in the community” were associated with adolescents’ needs to form their own identity and have autonomy. Conclusion This study shows that adolescent needs regarding medical device use are complex. It provides evidence to suggest that devices designed inclusively for adolescents may lead to improved adherence and also facilitate transition through the adolescent years and achievement of adolescent goals.

Not a minor problem: involving adolescents in medical device design research

This article outlines how adolescents are currently overlooked as a specific user group of medical devices and positions the contribution that ergonomics (human factors) can make in mitigating this issue. Details are provided of the current barriers to adolescent inclusion in medical device design research. The discussion then provides guidance and suggested strategies for researchers, clinical staff and medical device developers about how to overcome difficulties such as ethical considerations and gaining access to this specific population. This is tackled through discussion of: informed consent, assent, gatekeepers, confidentiality, appropriateness of topics and proxies. The overall aim of this article is to raise awareness about adolescents in ergonomics research, specifically for the elicitation of requirements for medical devices.

More holes than cheese. What prevents the delivery of effective, high quality and safe health care in England?

Abstract What prevents the delivery of effective, high quality and safe health care in the National Health Service (NHS) in England? This paper presents 760 challenges which 330 NHS staff reported as preventing the delivery of effective, high quality and safe care. Some problems have been known for over 25 years (staff shortages, finance and patient complexity) but other challenges raise questions about the commitment of the NHS to patient and staff safety. For example, Organisational Culture leading to ‘stifling bureaucracy’, ‘odds stacked against smooth […] working’ and Workload resulting in ‘firefighting daily’ and ‘perpetual crisis mode’. The role of Human Factors/Ergonomics professional input (engagement with safety scientists) is discussed in the context of success stories and examples of Human Factors Integration from other safety critical industries (Defence, Nuclear and Rail). Practitioner Summary: 760 challenges to the quality, effectiveness and safety of health care were identified at Human Factors/Ergonomics taster workshops in England. These are used to challenge health care providers to think about a Human Factors Integration (HFI systems) approach for safety, well-being and performance for all people involved in providing and receiving health care.

See I told you I was taking it! – Attitudes of adolescents with asthma towards a device monitoring their inhaler use: Implications for future design

Adherence to treatment in asthma is often poor, particularly in adolescents and children where the condition is most prevalent. Electronic monitoring devices have shown potential for improving inhaler use, yet little research has considered the attitudes of patients towards these devices. We gave seven adolescents with asthma an electronic monitoring device to use for one month and collected their views on important issues including monitoring and data sharing. Our results showed that participants felt positively about using the data to demonstrate responsibility for their condition to both their parents and medical professionals, but expressed concern for the attention the devices appearance could draw to them and their asthma. This paper considers the positive and negative perceptions of this novel device and provides new insight into the attitudes of adolescents towards inhaler monitoring, as well as future directions for design and development of monitoring devices for asthma and other chronic medical conditions.

Developing mHealth Apps with Researchers: Multi-Stakeholder Design Considerations

The authors have been involved with developing a number of mHealth smartphone Apps for use in health or wellness research in collaboration with researchers, clinicians and patient groups for clinical areas including Sickle Cell Disease, Attention Deficit Hyperactivity Disorder, asthma and infertility treatment. In these types of applications, end-users self-report their symptoms and quality of life or conduct psychometric tests. Physiological data may also be captured using sensors that are internal or external to the device. Following a discussion of the multiple stakeholders that are typically involved in small scale research projects involving end-user data collection, four Apps are used as case studies to explore the issue of non-functional requirements.

What are the pros and cons of electronically monitoring inhaler use in asthma? A multistakeholder perspective

Introduction Electronic monitoring devices (EMDs) are the optimal method for collecting objective data on inhaler use in asthma. Recent research has investigated the attitudes of patients with asthma towards these devices. However, no research to date has formally considered the opinions of stakeholders and decision-makers in asthma care. These individuals have important clinical requirements that need to be taken into account if EMDs are to be successfully provisioned, making collecting their opinions on the key barriers facing these devices a valuable process. Methods Three rounds of surveys in a Delphi format were used to assess the most important pros and cons of EMDs for asthma care in a sample of 31 stakeholders which included healthcare professionals and members of clinical commissioning groups. Results The respondents identified 29 pros and 32 cons. Pros that were rated as most important included new visual evidence to aid clinical discussions with a patient and an increase in patient involvement and motivation. The cons that were rated as most important included a need for more clinical evidence of the effectiveness of EMDs, as well as better clarity over who has responsibilities in managing, interpreting and discussing data with a patient. Conclusions The research provides a guide for EMD developers by highlighting where these devices may provide the most benefit as well as prioritising the key issues that need addressing if they are to be used effectively in everyday asthma care.

The dichotomy of the application of a systems approach in UK healthcare: the challenges and priorities for implementation

Abstract There is increasing demand for a systems approach within national healthcare guidelines to provide a systematic and sustainable framework for improvements in patient safety. Supported by this is the growing body of evidence within Human Factors/Ergonomics (HFE) healthcare literature for the inclusion of this approach in health service design, provision and evaluation. This paper considers the current interpretation of this within UK healthcare systems and the dichotomy which exists in the challenge to implement a systems approach. Three case studies, from primary and secondary care, present a systems approach, offering a novel perspective of primary care and blood sampling. These provide practical illustrations of how HFE methods have been used in collaboration with healthcare staff to understand the system for the purpose of professional education, design and safety of clinical activities. The paper concludes with the challenge for implementation and proposes five roles for systems HFE to support patient safety. Practitioner Summary: healthcare is classified as a complex and dynamic system within this paper and as such HFE system methods are presented as desirable to understand the system, to develop HFE tools, to deliver education and integrate HFE within healthcare systems.