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New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Chronic Obstructive Pulmonary Disease (COPD) is a widespread condition that accounts for 3 million deaths worldwide annually. Despite being extensive healthcare users, people with COPD (PwCOPD) only spend approximately 1% of their time with a healthcare professional. The rest of the time, they are encouraged to self-manage their condition. To encourage better self-management, Bond Digital Health have created a mobile phone app called COPD.Pal® that helps PwCOPD keep track of their condition. This pilot study aimed to assess the safety, engagement, and early efficacy of the app. 25 PwCOPD were recruited and given COPD.Pal® for 6-weeks. Healthcare usage, self-management knowledge, app engagement, dyspnoea, and health-related quality of life were measured at baseline and at 6-weeks. A feedback questionnaire was also collected at follow-up. T-tests investigated whether differences between the time points were evident in the data. No statistically significant differences were found between the time points for any of the variables measured. Average app engagement was 31.8 days with 84% using COPD.Pal® for 20 or more days during the 6-weeks. 89% of participants stated they would use the app regularly after the study, with 56% stating they’d use it long-term. This study determined that a digital, self-management app would be engaged with and early results indicate that the safety is non-inferior to standard care. Although self-management knowledge remained unaffected by app use, this study provided useful insights regarding how to improve this aspect. This represents one of few studies which involve end-users at an early stage of intervention development, an important strength of the research.

In this White Paper, we outline recommendations from the perspective of health psychology and behavioural science, addressing three research gaps: (1) What methods in the health psychology research toolkit can be best used for developing and evaluating digital health tools? (2) What are the most feasible strategies to reuse digital health tools across populations and settings? (3) What are the main advantages and challenges of sharing (openly publishing) data, code, intervention content and design features of digital health tools? We provide actionable suggestions for researchers joining the continuously growing Open Digital Health movement, poised to revolutionise health psychology research and practice in the coming years. This White Paper is positioned in the current context of the COVID-19 pandemic, exploring how digital health tools have rapidly gained popularity in 2020-2022, when world-wide health promotion and treatment efforts rapidly shifted from face-to-face to remote delivery. This statement is written by the Directors of the not-for-profit Open Digital Health initiative (n = 6), Experts attending the European Health Psychology Society Synergy Expert Meeting (n = 17), and the initiative consultant, following a two-day meeting (19-20th August 2021).

Purpose To assess the feasibility, safety, and effectiveness of a VIrtual PulmonAry Rehabilitation (VIPAR) program in a real-world setting. Patients and methods Twenty-one patients with stable chronic lung disease at a spoke site received (VIPAR) through live video conferencing with a hub where 24 patients were receiving 14 sessions of standard, outpatient, multi-disciplinary pulmonary rehabilitation (PR) in a hospital. We studied three such consecutive PR programs with 6-10 patients at each site. The hub had a senior physiotherapist, occupational therapist, exercise assistant, and guest lecturer, and the spoke usually had only an exercise instructor and nurse present. Uptake, adverse events (AEs), and early clinical changes were compared within and between groups. Travel distances were estimated using zip codes. Results Mean attendance was 11.0 sessions in the hub and 10.5 sessions in the spoke (P=0.65). There was a single (mild) AE (hypoglycemia) in all three hub programs and no AEs in the three spoke programs. Mean COPD Assessment Test scores improved from 25.3 to 21.5 in the hub (P

UNSTRUCTURED Despite recent and potent technological advances, the real-world implementation of remote digital health technology in the care and monitoring of patients with motor neuron disease has not yet been realized. Digital health technology may increase the accessibility to and personalization of care, whereas remote biosensors could optimize the collection of vital clinical parameters, irrespective of patients’ ability to visit the clinic. To facilitate the wide-scale adoption of digital health care technology and to align current initiatives, we outline a road map that will identify clinically relevant digital parameters; mediate the development of benefit-to-burden criteria for innovative technology; and direct the validation, harmonization, and adoption of digital health care technology in real-world settings. We define two key end products of the road map: (1) a set of reliable digital parameters to capture data collected under free-living conditions that reflect patient-centric measures and facilitate clinical decision making and (2) an integrated, open-source system that provides personalized feedback to patients, health care providers, clinical researchers, and caregivers and is linked to a flexible and adaptable platform that integrates patient data in real time. Given the ever-changing care needs of patients and the relentless progression rate of motor neuron disease, the adoption of digital health care technology will significantly benefit the delivery of care and accelerate the development of effective treatments.

Chronic Obstructive Pulmonary Disease (COPD) is a long-term progressive inflammatory lung disease causing chronic breathlessness and many hospital admissions. It affects up to 1.2 million people in the UK. To help people with COPD self-manage their condition we developed, in partnership with healthcare users, a digital mobile phone app called COPD.Pal®. We report the first user feedback of COPD.Pal®, applying the Technology Acceptance Model (TAM) theoretical framework. 11 participants engaged with a click dummy version of COPD.Pal® before being asked questions relating to their experiences. A deductive, semantic, reflexive thematic analysis was conducted to analyse their individual and collective experiences. The study was registered at Clinical Trials.gov (NCT04142957). Two overarching themes resulted: Ease of Use and Perceived Usefulness. Within the former, participants discussed how they wanted flexibility and choice in how they engaged with the app; including how often they used it. Additionally, they discussed how the app layout should make it straightforward to use, whilst unanimously agreeing that COPD.Pal® provided this. Within Perceived Usefulness, participants discussed how they wanted the information they entered into the app to be useful, in addition to the app providing resources regarding COPD. Lastly, there was disagreement regarding preferences for further app development. We found that COPD.Pal® was usable and acceptable by people with COPD and TAM provided a useful theoretical framework for both structuring discussions with users and analysing their comments. Electronic supplementary material The online version of this article (10.1007/s12553-020-00494-7) contains supplementary material, which is available to authorized users.

National Health Service (NHS) ethics is a term, which can bring a bead of sweat to even the most experienced researcher. Although it can be a daunting process, if broken down into more manageable chunks, it is a worthwhile experience. This article will focus on providing tips and advice on writing the protocol, followed by tips on how to navigate the NHS ethics system.

Presenting your work at any conference can be nerve-racking. However, this can be even worse if you are facing a room full of healthcare professionals who are at the coalface of your field of research. This article aims to provide some hints and tips that I have gained from my experiences presenting to, and working alongside, clinicians. Primarily, these tips are to be concise, ensure psychological theories are easy to follow, keep methodological details to a minimum and have a good conclusion.

Within Hywel Dda University Health Board, the Welsh Government expectations for managing patients with chronic respiratory conditions are not being adequately met. The Pulmonary Rehabilitation (PR) service does not exist in Ceredigion; there is a limited service in Pembrokeshire; and the service in Carmarthenshire now has an 8-12 month waiting list. By working in partnership with industry the PR team have developed a Virtual pulmonary rehabilitation (VIPAR) service; consisting of a hub and spoke model of delivery using video-conferencing to link the hub site in Carmarthenshire, to a spoke site in Ceredigion that upholds the principles of prudent healthcare. VIPAR provides a service to patients in a more timely fashion, as the health board is unable to offer Pulmonary Rehabilitation to COPD patients admitted to hospital (with an exacerbation of their COPD) within 2 weeks post discharge. The partnership worked to increase the efficiency and equity of service provision for Pulmonary Rehabilitation programs in rural areas, using video-conferencing (VC). The project capitalized on an investment opportunity, expanding on the existing model of delivery, to enhance the provision of pulmonary rehabilitation, reduce inequalities and encourage community resilience. The project fits the needs and circumstances of the citizen, by allowing service delivery closer to home and creating access where previous there was none. Health improvements were gained by all participants attending the program. The results were comparable between the hub and spoke site participants and were clinically important. Without the VIPAR service, patients would not have received PR intervention nor the health benefits. VIPAR has also shown to reduce drive time for patients; this reduces the carbon footprint of the service. By developing more spoke sites in rural areas both staff and patients will no longer need to travel long distances to access / deliver the service.