User involvement in digital health: Working together to design smart home health technology.

BACKGROUND: Public involvement adds value to numerous aspects of health research, yet few studies have attempted to evaluate its impact on research. Evidence of such impact is needed to develop recommendations for best practice and ensure adequate resourcing. AIM: To evaluate public involvement within a large interdisciplinary Science, Technology, Engineering and Mathematics (STEM) research project that focused on digital health. METHODS: The evaluation was conducted with members of the project's Public Advisory Groups (PAG) and with researchers who had participated in involvement activities. Two questionnaires were designed based on a public involvement value systems and clusters framework. RESULTS: Responses from members of the PAG (n = 10) were mostly positive towards normative values, which include moral, ethical and political aspects of involvement in research, and towards values concerning the conduct of public involvement and best practices. Researchers' responses (n = 16) indicated they felt that involvement was generally effective and increased the quality, relevance and generalizability of their work. However, their responses about the validity of involvement in research were varied. They also highlighted several challenges including how well public involvement impacted on research, how decisions made in the research might differ from the views generated from public involvement, and barriers to researchers' participation. DISCUSSION AND CONCLUSION: Our evaluation suggests that members of the public and the researchers value involvement. However, there is a need to consider how to embed public involvement to an even greater extent in STEM contexts and a need to address any barriers for researchers' own involvement.

Talk, Text, Tag? Understanding Self-Annotation of Smart Home Data from a User's Perspective.

Delivering effortless interactions and appropriate interventions through pervasive systems requires making sense of multiple streams of sensor data. This is particularly challenging when these concern people's natural behaviours in the real world. This paper takes a multidisciplinary perspective of annotation and draws on an exploratory study of 12 people, who were encouraged to use a multi-modal annotation app while living in a prototype smart home. Analysis of the app usage data and of semi-structured interviews with the participants revealed strengths and limitations regarding self-annotation in a naturalistic context. Handing control of the annotation process to research participants enabled them to reason about their own data, while generating accounts that were appropriate and acceptable to them. Self-annotation provided participants an opportunity to reflect on themselves and their routines, but it was also a means to express themselves freely and sometimes even a backchannel to communicate playfully with the researchers. However, self-annotation may not be an effective way to capture accurate start and finish times for activities, or location associated with activity information. This paper offers new insights and recommendations for the design of self-annotation tools for deployment in the real world.

Randomised controlled trial of high versus ad libitum water intake in patients with autosomal dominant polycystic kidney disease: rationale and design of the DRINK feasibility trial.

INTRODUCTION: Vasopressin stimulates cyst growth in autosomal dominant polycystic kidney disease (ADPKD) leading to enlarged kidneys, hypertension and renal failure. Vasopressin receptor blockade slows disease progression. Physiological suppression of vasopressin secretion through high water (HW) intake could achieve a similar effect, necessitating a definitive large-scale trial of HW intake in ADPKD. The objective of the DRINK trial is to answer the key design and feasibility questions required to deliver a successful definitive water intake trial. METHODS AND ANALYSIS: We describe the design of a single-centre, open-label, prospective, randomised controlled trial. The "Determining feasibility of R andomisation to high vs. ad libitum water In take in Polycystic K idney Disease" (DRINK) trial aims to enrol 50 patients with ADPKD, over the age of 16 years with an estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m2. Participants will be randomised 1:1 to HW intake based on an individualised water intake prescription, or to ad libitum (AW) water intake. The HW group will aim for a dilute urine (urine osmolality ≤270 mOsm/kg) as a surrogate marker of vasopressin suppression, and those in the AW group will target more concentrated urine. Participants will have an 8-week treatment period, and will be seen at weeks 0, 2, 4 and 8, undergoing assessments of fluid status, renal function and serum and urine osmolalities. They will receive dietary advice, and self-monitor urine specific gravity and fluid intake. The trial employs smartphone technology to permit home monitoring and remote direct data capture. The primary feasibility end points are recruitment rate and separation between arms in measured urinary osmolality. Key secondary assessments include acceptability, adherence, health-related quality of life, acute effects of HW intake on measured (51Cr-EDTA) and eGFR and ADPKD-related pain. ETHICS AND DISSEMINATION: Ethical approval was awarded by the East of England Essex Research Ethics Committee (16/EE/0026). The results of DRINK will be submitted to peer-reviewed journals, and presented to patients via the PKD Charity. TRIAL REGISTRATION NUMBER: NCT02933268 and ISCRTN16794957.

Privacy, boundaries and smart homes for health: An ethnographic study.

This article explores how people negotiate borders and boundaries within the home, in the context of health and the introduction of new technologies. We draw on an ethnographic study involving a socially diverse group of people, which included people with experience of telecare or smart home energy systems. Participants engaged in various strategies to regulate the borders of their home, even though new technologies have begun to change the nature of these borders. Participants managed health conditions but also their use of technology through boundary work that permitted devices to be more or less visible and integrated within the home. Findings highlight that if smart healthcare technologies are to be accepted in the home then there is a need for mechanisms that allow people to control the interpretation of data and flow of information generated about them and their households.

Could In-Home Sensors Surpass Human Observation of People with Parkinson's at High Risk of Falling? An Ethnographic Study.

Self-report underpins our understanding of falls among people with Parkinson's (PwP) as they largely happen unwitnessed at home. In this qualitative study, we used an ethnographic approach to investigate which in-home sensors, in which locations, could gather useful data about fall risk. Over six weeks, we observed five independently mobile PwP at high risk of falling, at home. We made field notes about falls (prior events and concerns) and recorded movement with video, Kinect, and wearable sensors. The three women and two men (aged 71 to 79 years) having moderate or severe Parkinson's were dependent on others and highly sedentary. We most commonly noted balance protection, loss, and restoration during chair transfers, walks across open spaces and through gaps, turns, steps up and down, and tasks in standing (all evident walking between chair and stairs, e.g.). Our unobtrusive sensors were acceptable to participants: they could detect instability during everyday activity at home and potentially guide intervention. Monitoring the route between chair and stairs is likely to give information without invading the privacy of people at high risk of falling, with very limited mobility, who spend most of the day in their sitting rooms.

Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial.

BACKGROUND: Guided self-help is a recommended first-step treatment for bulimia nervosa, binge eating disorder and atypical variants of these disorders. Further research is needed to compare guided self-help that is delivered face-to-face versus via email. METHODS/DESIGN: This clinical trial uses a randomised, controlled design to investigate the effectiveness of providing guided self-help either face-to-face or via e-mail, also using a delayed treatment control condition. At least 17 individuals are required per group, giving a minimum N of 51. DISCUSSION: Symptom outcomes will be assessed and estimates of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision. The trial has been approved by an ethics review board and was registered with ClinicalTrials.gov NCT01832792 on 9 April 2013.

Primary care use of antipsychotic drugs: an audit and intervention study.

BACKGROUND: Concerns regarding the use of antipsychotic medication in secondary care suggested an examination of primary care prescribing. AIM: To audit and intervene in the suboptimal prescribing of antipsychotic drugs to primary care patients. DESIGN OF STUDY: Cross-sectional prevalence: subsequent open treatment intervention. SETTING: Seven of the 29 practices in the Eastern Hull Primary Care Trust. METHODS: Criteria for best practice were developed, against which prescribing standards were tested via audit. Patients identified as suboptimally prescribed for were invited to attend an expert review for intervention. RESULTS: 1 in 100 of 53,000 patients was prescribed antipsychotic treatment. Diagnoses indicating this were impossible to ascertain reliably. Half the regimes failed one or more audit criteria, leaving diagnosis aside. Few practices agreed to patients being approached: of 179 invitations sent, only 40 patients attended. Of 32 still taking an antipsychotic drug, 26 required changes. Mean audit criteria failed were 3.4, lack of psychotic disorder diagnosis and problematic side effects being most frequent. Changes were fully implemented in only 16 patients: reasons for complete or partial failure to implement recommendations included the wishes or inaction of patients and professionals, and worsening of symptoms including two cases of antipsychotic withdrawal syndrome. CONCLUSION: Primary care prescribing of antipsychotic drugs is infrequent, but most is unsatisfactory. Intervention is hampered by pluralistic reluctance: even with expert guidance, rationalisation is not without risk. Use of antipsychotic drugs in primary care patients whose diagnosis does not warrant this should be avoided. HOW THIS FITS IN: This study adds to concerns regarding high levels of off-licence use of potentially harmful medication. It adds evidence of major difficulties in rationalizing suboptimal regimes despite expert input. Relevance to the clinician is that it is better to avoid such regimes in the first place especially if there is no clear 'exit strategy': if in doubt, seek a specialist opinion.