BackgroundThis paper provides three illustrations of how the “person-based approach” can be used to assess and enhance the acceptability and feasibility of an intervention during the early stages of development and evaluation. The person-based approach involves using mixed methods research to systematically investigate the beliefs, attitudes, needs and situation of the people who will be using the intervention. The in-depth understanding of users’ perspectives derived from this research then enables intervention developers to design or modify the intervention to make it more relevant, persuasive, accessible and engaging.MethodsThe first illustration describes how relevant beliefs and attitudes of people with asthma were identified from the existing qualitative and quantitative literature and then used to create guiding principles to inform the design of a web-based intervention to improve quality of life. The second illustration describes how qualitative “think-aloud” interviews and patient and public involvement (PPI) input are used to improve the acceptability of a booklet for people with asthma. In the third illustration, iterative think-aloud methods are used to create a more accurate and accessible activity planner for people with diabetes.ResultsIn the first illustration of the person-based approach, we present the guiding principles we developed to summarise key design issues/objectives and key intervention features to address them. The second illustration provides evidence from interviews that positive, non-medical messages and images were preferred in booklet materials for people with asthma. The third illustration demonstrates that people with diabetes found it difficult to complete an online activity planner accurately, resulting in incorrect personalised advice being given prior to appropriate modification of the planner.ConclusionsThe person-based approach to intervention development can complement theory- and evidence-based development and participant input into intervention design, offering a systematic process for systematically investigating and incorporating the views of a wide range of users.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-015-0033-z) contains supplementary material, which is available to authorized users.

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Trials of digital interventions can yield extensive, in-depth usage data, yet usage analyses tend to focus on broad descriptive summaries of how an intervention has been used by the whole sample. This paper proposes a novel framework to guide systematic, fine-grained usage analyses that better enables understanding of how an intervention works, when, and for whom. The framework comprises three stages to assist in the following: (1) familiarization with the intervention and its relationship to the captured data, (2) identification of meaningful measures of usage and specifying research questions to guide systematic analyses of usage data, and (3) preparation of datasheets and consideration of available analytical methods with which to examine the data. The framework can be applied to inform data capture during the development of a digital intervention and/or in the analysis of data after the completion of an evaluation trial. We will demonstrate how the framework shaped preparation and aided efficient data capture for a digital intervention to lower transmission of cold and flu viruses in the home, as well as how it informed a systematic, in-depth analysis of usage data collected from a separate digital intervention designed to promote self-management of colds and flu. The Analyzing and Measuring Usage and Engagement Data (AMUsED) framework guides systematic and efficient in-depth usage analyses that will support standardized reporting with transparent and replicable findings. These detailed findings may also enable examination of what constitutes effective engagement with particular interventions.

BackgroundIn designing digital interventions for healthcare, it is important to understand not just whether interventions work but also how and for whom—including whether individual intervention components have different effects, whether a certain usage threshold is required to change behavior in each intervention and whether usage differs across population subgroups.PurposeWe investigated these questions using data from a large trial of the digital PRimary care trial of a website based Infection control intervention to Modify Influenza-like illness and respiratory tract infection Transmission) (PRIMIT) intervention, which aimed to reduce respiratory tract infections (RTIs) by increasing hand hygiene behavior.MethodBaseline and follow-up questionnaires measured behaviors, intentions and attitudes in hand hygiene. In conjunction with objective measures of usage of the four PRIMIT sessions, we analysed these observational data to examine mechanisms of behavior change in 8993 intervention users.ResultsWe found that the PRIMIT intervention changed behavior, intentions and attitudes, and this change was associated with reduced RTIs. The largest hand hygiene change occurred after the first session, with incrementally smaller changes after each subsequent session, suggesting that engagement with the core behavior change techniques included in the first session was necessary and sufficient for behavior change. The intervention was equally effective for men and women, older and younger people and was particularly effective for those with lower levels of education.ConclusionsOur well-powered analysis has implications for intervention development. We were able to determine a ‘minimum threshold’ of intervention engagement that is required for hand hygiene change, and we discuss the potential implications this (and other analyses of this type) may have for further intervention development. We also discuss the application of similar analyses to other interventions.

Asthma is a common non-communicable disease, often characterized by activity limitation, negative effects on social life and relationships, problems with finding and keeping employment, and poor quality of life. The objective of the present study was to conduct a systematic review of the literature investigating the potential factors impacting quality of life (QoL) in asthma. Electronic searches were carried out on: MEDLINE, EMBASE, PsycINFO, the Cochrane Library, and Web of Science (initial search April 2017 and updated in January 2019). All primary research studies including asthma, psychological or physical health factors, and quality of life were included. Narrative synthesis was used to develop themes among findings in included studies in an attempt to identify variables impacting QoL in asthma. The search retrieved 43 eligible studies that were grouped in three themes: psychological factors (including anxiety and depression, other mental health conditions, illness representations, and emotion regulation), physical health factors (including BMI and chronic physical conditions), and multifactorial aspects, including the interplay of health and psychological factors and asthma. These were found to have a substantial impact on QoL in asthma, both directly and indirectly, by affecting self-management, activity levels and other outcomes. Findings suggest a complex and negative effect of health and psychological factors on QoL in asthma. The experience of living with asthma is multifaceted, and future research and intervention development studies should take this into account, as well as the variety of variables interacting and affecting the person.

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Asthma is a heterogeneous, complex disease with clinical phenotypes that incorporate persistent symptoms and acute exacerbations. It affects many millions of Europeans throughout their education and working lives and puts a heavy cost on European productivity. There is a wide spectrum of disease severity and control. Therapeutic advances have been slow despite greater understanding of basic mechanisms and the lack of satisfactory preventative and disease modifying management for asthma constitutes a significant unmet clinical need. Preventing, treating and ultimately curing asthma requires co-ordinated research and innovation across Europe. The European Asthma Research and Innovation Partnership (EARIP) is an FP7-funded programme which has taken a co-ordinated and integrated approach to analysing the future of asthma research and development. This report aims to identify the mechanistic areas in which investment is required to bring about significant improvements in asthma outcomes.

ObjectiveTo assess the feasibility of a randomised controlled trial (RCT) and acceptability of an asthma self-management digital intervention to improve asthma-specific quality of life in comparison with usual care.Design and settingA two-arm feasibility RCT conducted across seven general practices in Wessex, UK.ParticipantsPrimary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet.Interventions‘My Breathing Matters’ (MBM) is a digital asthma self-management intervention designed using theory, evidence and person-based approaches to provide tailored support for both pharmacological and non-pharmacological management of asthma symptoms.OutcomesThe primary outcome was the feasibility of the trial design, including recruitment, adherence and retention at follow-up (3 and 12 months). Secondary outcomes were the feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control.ResultsPrimary outcomes: 88 patients were recruited (target 80). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0–25, IQR 8). Consistent trends were observed to improvements in asthma-related patient-reported outcome measures.ConclusionsThis study demonstrated the feasibility and acceptability of a definitive RCT that is required to determine the clinical and cost-effectiveness of a digital asthma self-management intervention.Trial registration number ISRCTN15698435.