Raising the Digital Profile of Facial Palsy: National Surveys of Patients' and Clinicians' Experiences of Changing UK Treatment Pathways and Views on the Future Role of Digital Technology.

BACKGROUND: Facial nerve palsy leaves people unable to move muscles on the affected side of their face. Challenges exist in patients accessing facial neuromuscular retraining (NMR), a therapy used to strengthen muscle and improve nerve function. Access to therapy could potentially be improved through the use of digital technology. However, there is limited research available on patients' and clinicians' views about the potential benefits of such telerehabilitation based on their lived experiences of treatment pathways. OBJECTIVE: This study aims to gather information about facial palsy treatment pathways in the United Kingdom, barriers to accessing NMR, factors influencing patient adherence, measures used to monitor recovery, and the potential value of emerging wearable digital technology. METHODS: Separate surveys of patients with facial palsy and facial therapy specialists were conducted. Questionnaires explored treatment pathways and views on telerehabilitation, were co-designed with users, and followed a similar format to enable cross-referencing of responses. A follow-up survey of national specialists investigated methods used to monitor recovery in greater detail. Analysis of quantitative data was conducted allowing for data distribution. Open-text responses were analyzed using thematic content analysis. RESULTS: A total of 216 patients with facial palsy and 25 specialist therapists completed the national surveys. Significant variations were observed in individual treatment pathways. Patients reported an average of 3.27 (SD 1.60) different treatments provided by various specialists, but multidisciplinary team reviews were rare. For patients diagnosed most recently, there was evidence of more rapid initial prescribing of corticosteroids (prednisolone) and earlier referral for NMR therapy. Barriers to NMR referral included difficulties accessing funding, shortage of specialist therapists, and limited awareness of NMR among general practitioners. Patients traveled long distances to reach an NMR specialist center; 9% (8/93) of adults reported traveling ≥115 miles. The thematic content analysis demonstrates positive attitudes to the introduction of digital technology, with similar incentives and barriers identified by both patients and clinicians. The follow-up survey of 28 specialists uncovered variations in the measures currently used to monitor recovery and no agreed definitions of a clinically significant change for any of these. The main barriers to NMR adherence identified by patients and therapists could all be addressed by using suitable real-time digital technology. CONCLUSIONS: The study findings provide valuable information on facial palsy treatment pathways and views on the future introduction of digital technology. Possible ways in which emerging sensor-based digital technology can improve rehabilitation and provide more rigorous evidence on effectiveness are described. It is suggested that one legacy of the COVID-19 pandemic will be lower organizational barriers to this introduction of digital technology to assist NMR delivery, especially if cost-effectiveness can be demonstrated.

Usability and Preliminary Efficacy of an Artificial Intelligence-Driven Platform Supporting Dietary Management in Diabetes: Mixed Methods Study.

BACKGROUND: Nutrition plays an important role in diabetes self-management. Web-based diabetes care, driven by artificial intelligence (AI), enables more personalized care. OBJECTIVE: This study aimed to examine the usability and preliminary efficacy of a web-based AI-driven nutrition platform to support people with diabetes and their carers in identifying healthy recipes, meal planning, and web-based shopping. METHODS: Diabetes UK signposted people with diabetes and their carers to the platform's study-specific portal through its website, social media, and newsletters. A total of 73 adult participants with prediabetes or diabetes or their carers completed the baseline web-based survey. Of these 73 participants, 23 (32%) completed a web-based survey after 8 weeks of platform use. Web-based semistructured interviews were conducted with platform users (7/23, 30%) who agreed to be followed up and diabetes experts (n=3) who had nutrition and platform knowledge. The intervention consists of a web-based platform that incorporates AI to personalize recipes, meal planning, and shopping list experiences and was made available for 8 weeks. Baseline characteristics, satisfaction, system usability, and diabetes-related and general health indicators were assessed before and after using the platform for 8 weeks. RESULTS: Reductions in weight (mean difference 4.5 kg/m2, 95% CI 1.0-12.0; P=.009; Cliff δ=0.33) and waist size (mean difference 3.9 cm, 95% CI 2.0-6.5; P=.008; Cliff δ=0.48) were found. Most of the participants (151/217, 69.6%) did not regularly use the platform and had low or very low engagement scores. However, the platform was perceived as accessible with no need for additional assistance (11/21, 52%), user-friendly (8/21, 38%), and easy to use (8/21, 38%), regardless of some usability issues. Saving recipes was the most popular feature, with 663 saved recipes. CONCLUSIONS: This study indicated that the usability of the nutrition platform was well perceived by users and their carers. As participants managed their diabetes well, adding an education component would be specifically relevant for people less familiar with the role of diet in diabetes management. To assess the platform's effectiveness in improving diabetes-related health indicators, controlled studies with a larger and more diverse participant sample are recommended.

Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study.

BACKGROUND: There is a dearth of research to support the treatment of people with postural tachycardia syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a feasibility trial protocol and a rehabilitation intervention for people living with PoTS. METHODS: The intervention and feasibility trial design were co-created as part of the PostUraL tachycardia Syndrome Exercise (PULSE) study. We used the 'three co's framework' of co-define, co-design and co-refine. Recruitment included key national charities and National Health Service Trusts treating people living with PoTS in the UK. Eighteen patient and public involvement members attended the co-define session, and 16 co-creators with a mix of expertise attended the subsequent co-design and co-refine sessions. Seven intervention practitioners were trained in the rehabilitation intervention, providing feedback for further co-refinement. RESULTS: The final co-created intervention comprises online physical activity, and lifestyle and behaviour change support sessions. It is based on functional movement activities using a patient-centred approach tailored to individual needs. Physical activity intensity is guided by individuals' perception of effort rather than by objective measures. Recumbent bikes are provided for home use. Patients deemed randomisation to be acceptable because research in this area was considered important. CONCLUSIONS: An innovative approach was used to co-create the PULSE intervention and feasibility trial protocol to meet the evidence-based and logistical needs of people living with PoTS, clinicians, service deliverers, third-sector organisations, academics and funders. This can be used as a successful example and template for future research internationally. People living with PoTS were recognised as experts and involved in every aspect of conceptualisation, design and refinement. This complex rehabilitation intervention is currently being tested in a randomised feasibility trial comparing the PULSE intervention with best-practice usual care for people living with PoTS. TRIAL REGISTRATION: ISRCTN45323485 was registered on April 7, 2020.

Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study.

BACKGROUND: The PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with Postural Tachycardia Syndrome (PoTS). The original trial protocol was published in BMC Pilot & Feasibility Studies (accessible at https://doi.org/10.1186/s40814-020-00702-1 ). The PULSE intervention consists of (1) individual assessment; (2) 12-week, twice-weekly, supervised exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention is best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. Sixty-two people (aged 18-60 years) with a confirmed diagnosis of PoTS will be invited to enrol on a feasibility RCT with an embedded qualitative study. The primary outcome will be feasibility; process-related measures will include eligibility, recruitment, randomisation and withdrawal rates, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes will be assessed. In response to the COVID-19 pandemic, here we describe amendments to the trial protocol. METHODS: Restrictions imposed by the COVID-19 pandemic meant it was necessary to change the delivery of the PULSE and control interventions. These changes reflected the need to limit the risk of COVID-19 transmission in a clinical population, some of whom were at increased risk of contracting the virus and suffering serious illness. The major change was that the originally intended centre-based PULSE and control interventions would now be delivered remotely on-line. Subsequently, there were minor changes to the participant eligibility criteria. These decisions followed an on-line co-creation session with people affected by PoTS, and relevant public and professional stakeholders. CONCLUSIONS: We present an update of the original trial protocol in response to the COVID-19 pandemic. No participants were recruited to the original protocol; thus, results will reflect the on-line delivery of the intervention. PULSE will be the first randomised trial to assess the feasibility of conducting a definitive multi-centre RCT testing supervised on-line exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with PoTS. TRIAL REGISTRATION: ISRCTN45323485 registered on 7 April 2020.

Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study.

BACKGROUND: Postural orthostatic tachycardia syndrome (POTS) is an autonomic nervous system disorder causing an abnormal cardiovascular response to upright posture. It affects around 0.2% of the population, most commonly women aged 13 to 50 years. POTS can be debilitating; prolonged episodes of pre-syncope and fatigue can severely affect activities of daily living and health-related quality of life (HRQoL). Medical treatment is limited and not supported by randomised controlled trial (RCT) evidence. Lifestyle interventions are first-line treatment, including increased fluid and salt intake, compression tights and isometric counter-pressure manoeuvres to prevent fainting. Observational studies and small RCTs suggest exercise training may improve symptoms and HRQoL in POTS, but evidence quality is low. METHODS: Sixty-two people (aged 18-40 years) with a confirmed diagnosis of POTS will be invited to enrol on a feasibility RCT with embedded qualitative study. The primary outcome will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes including sub-maximal recumbent bike exercise test, active stand test and HRQoL will be measured at 4 and 7 months post-randomisation by researchers blinded to treatment allocation. The PostUraL tachycardia Syndrome Exercise (PULSE) intervention consists of (1) individual assessment; (2) 12-week, once to twice-weekly, supervised out-patient exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention will be best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. For the embedded qualitative study, participants (n = 10 intervention, n = 10 control) will be interviewed at baseline and 4 months post-randomisation to assess acceptability and the feasibility of progressing to a definitive trial. DISCUSSION: There is very little high-quality research investigating exercise rehabilitation for people with POTS. The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with POTS. TRIAL REGISTRATION: ISRCTN45323485 registered on 7 April 2020.

Electronic Assisted Living Technology: Interim Systematic Review Results - The Evidence for Creative Methodologies.

Despite reported benefits of creative methodologies for the design and development of electronic Assisted Living Technologies (eALT), there exists a divide between design and health research, leaving health researchers wishing to pursue creative methods uninformed with regards choice of appropriate methods. This paper describes interim and emerging results from a systematic review which aimed to explore the value of creative methodologies for the design and development of eALT which may form part of the solution to the challenges of the ageing population.