Randomised Feasibility Study Research Articles

Can mixed reality technologies teach surgical skills better than traditional methods? A prospective randomised feasibility study

BackgroundBasic surgical skills teaching is often delivered with didactic audio-visual content, and new digital technologies may allow more engaging and effective ways of teaching to be developed. The Microsoft HoloLens 2 (HL2) is a multi-functional mixed reality headset. This prospective feasibility study sought to assess the device as a tool for enhancing technical surgical skills training.MethodsA prospective randomised feasibility study was conducted. 36 novice medical students were trained to perform a basic arteriotomy and closure using a synthetic model. Participants were randomised to receive a structured surgical skills tutorial via a bespoke mixed reality HL2 tutorial (n = 18), or via a standard video-based tutorial (n = 18). Proficiency scores were assessed by blinded examiners using a validated objective scoring system and participant feedback collected.ResultsThe HL2 group showed significantly greater improvement in overall technical proficiency compared to the video group (10.1 vs. 6.89, p = 0.0076), and a greater consistency in skill progression with a significantly narrower range of scores (SD 2.48 vs. 4.03, p = 0.026). Participant feedback showed the HL2 technology to be more interactive and engaging with minimal device related problems experienced.ConclusionsThis study has demonstrated that mixed reality technology may provide a higher quality educational experience, improved skill progression and greater consistency in learning when compared to traditional teaching methodologies for basic surgical skills. Further work is required to refine, translate, and evaluate the scalability and applicability of the technology across a broad range of skills-based disciplines.

Feasibility study of high-intensity interval training to reduce cardiometabolic disease risks in individuals with acute spinal cord injury

IntroductionIndividuals ageing with spinal cord injury (SCI) experience an accelerated trajectory of diseases and disorders, such as cardiovascular disease and diabetes, that resemble those experienced with ageing alone. Currently, an...

P769 Randomised feasibility study of preoperative medical nutrition therapy in adults undergoing surgery for Crohn’s disease

Abstract Background Preoperatively patients with Crohn’s disease are at high risk of malnutrition. Patients requiring surgery to manage stricturing disease are often advised to follow a low residue/low fibre diet to reduce risk of bowel obstruction. This diet is usually nutritionally inadequate and may negatively affect nutritional status. Research suggests that preoperative exclusive enteral nutrition (EEN) improves nutritional status, reduces intestinal inflammation and consequently improves surgical outcomes. Recently the Crohn’s disease exclusion diet has been shown to reduce intestinal inflammation in adults but its use preoperatively has not been reported. This research aimed to determine whether it is feasible to recruit and retain patients with Crohn’s disease in a single-blinded, multicentre, randomised controlled trial of three preoperative nutritional therapies. Methods Patients undergoing elective surgery to manage Crohn’s disease at three New Zealand tertiary care hospitals (Christchurch, Auckland and Waikato hospitals), aged >18 years old, with body mass index (BMI) > 18.5 kg/m2 and without recent significant weight loss were eligible to participate. Patients were randomised to six weeks of preoperative EEN, partial enteral nutrition with Phase-1 Crohn’s Disease Exclusion Diet (CDED) or standard care. Nutritional and radiological assessment at baseline and preoperatively was completed and surgical outcomes recorded. Descriptive statistical analysis was undertaken. Health and Disability Ethics Committee approval was given (20/NTB/134). Results Over 18 months (September 2020 to March 2022), 48 patients were screened and 17 were randomised. Patient characteristics were: median age 37.9 (range, 28-68) years, 9 (53%) female, 10 (59%) on biologic medication, median BMI 25.7 (range, 19.7-38.6) kg/m2 and 2 (12%) had low fat-free mass index. Medical nutrition therapy was completed by 13/17 (76%) patients (EEN n=4, CDED n=4 and standard care n=5) and four withdrew. BMI and simplified magnetic resonance index of activity (MaRIA) score changed by a median of -0.3 (range, -1.8 to 2.1) kg/m2 and 0.5 (range, -3 to 2) points respectively. At day 30, 10 patients had no surgical complications. Three patients had Clavien Dindo Grade 2 complications; one (standard care group) experienced fever treated with antibiotics, one (standard care group) had postoperative ileus requiring total parenteral nutrition and one (CDED group) required a blood transfusion postoperatively and antibiotics for a wound infection. Conclusion Patients who need elective Crohn’s disease surgery tolerate preoperative EEN or CDED. Use of preoperative nutrition therapies are feasible and the impact on surgical outcomes should be assessed in a larger study.

A multi-center, randomized, 12-month, parallel-group, feasibility study to assess the acceptability and preliminary impact of family navigation plus usual care versus usual care on attrition in managing pediatric obesity: a study protocol

BackgroundPediatric obesity management can be successful, but some families discontinue care prematurely (i.e., attrition), limiting treatment impact. Attrition is often a consequence of barriers and constraints that limit families’ access to obesity management. Family Navigation (FN) can improve access, satisfaction with care, and treatment outcomes in diverse areas of healthcare. To help our team prepare for a future effectiveness trial, the objectives of our randomized feasibility study are to (i) explore children’s and caregivers’ acceptability of FN and (ii) examine attrition, measures of study rigor and conduct, and responses to FN + Usual Care vs Usual Care by collecting clinical, health services, and health economic data.MethodsIn our 2.5-year study, 108 6–17-year-olds with obesity and their caregivers will be randomized (1:1) to FN + Usual Care or Usual Care after they enroll in obesity management clinics in Calgary and Mississauga, Canada. Our Stakeholder Steering Committee and research team will use Experience-Based Co-Design to design and refine our FN intervention to reduce families’ barriers to care, maximizing the intervention dose families receive. FN will be delivered by a navigator at each site who will use logistical and relational strategies to enhance access to care, supplementing obesity management. Usual Care will be offered similarly at both clinics, adhering to expert guidelines. At enrollment, families will complete a multidisciplinary assessment, then meet regularly with a multidisciplinary team of clinicians for obesity management. Over 12 months, both FN and Usual Care will be delivered virtually and/or in-person, pandemic permitting. Data will be collected at 0, 3, 6, and 12 months post-baseline. We will explore child and caregiver perceptions of FN acceptability as well as evaluate attrition, recruitment, enrolment, randomization, and protocol integrity against pre-set success thresholds. Data on clinical, health services, and health economic outcomes will be collected using established protocols. Qualitative data analysis will apply thematic analysis; quantitative data analysis will be descriptive.DiscussionOur trial will assess the feasibility of FN to address attrition in managing pediatric obesity. Study data will inform a future effectiveness trial, which will be designed to test whether FN reduces attrition.Trial registrationThis trial was registered prospectively at ClinicalTrials.gov (#NCT05403658; first posted: June 3, 2022).

Multisite randomized feasibility study of Problem-Solving Training for care partners of adults with traumatic brain injury during inpatient rehabilitation.

Problem-Solving Training (PST) during inpatient rehabilitation could provide care partners the skills needed to manage their life roles after discharge. Determine the feasibility of PST+ Education versus Education for care partners of adults with traumatic brain injury (TBI) during inpatient rehabilitation. We conducted a multisite randomized feasibility trial across three sites. We present recruitment rates, reasons for refusal to participate, and reasons for non-completion of interventions. We measured client satisfaction, participant engagement, and fidelity for both interventions. We compared change in depressive symptoms and caregiver burden between PST and Education groups. Though the interventions were generally feasible, recruitment and retention rates were lower than anticipated largely due to the COVID-19 pandemic. Participants who completed >3 sessions were less likely to be employed full-time and more often spouses and co-residing. Length of inpatient rehabilitation stay was correlated with number of sessions completed. We observed potential benefits of PST over Education, specifically for reducing depression symptoms and caregiver burdenCONCLUSION:High satisfaction, engagement, and fidelity, overall recruitment and retention, and positive change in outcomes suggest that PST is generally feasible and beneficial for care partners of persons with TBI. Adaptions, such as developing a 3-session version of PST, could improve feasibility.

Robot-assisted laparoscopic radical cystectomy with intracorporeal ileal conduit diversion versus open radical cystectomy with ileal conduit for bladder cancer in an ERAS setup (BORARC): protocol for a single-centre, double-blinded, randomised feasibility study

BackgroundRadical cystectomy (RC) with urinary diversion is the recommended treatment for selected cases of non-metastatic high-risk non-muscle-invasive and muscle-invasive bladder cancer. It remains unknown whether robot-assisted laparoscopic cystectomy (RARC) offers any advantage in terms of safety compared to open cystectomy (ORC) in an Enhanced Recovery After Surgery (ERAS) setup. Blinded randomised controlled trials (RCTs) between RARC versus ORC have never been conducted in cystectomy patients. We will investigate the feasibility of conducting a double-blinded RCT comparing ORC with RARC with intra-corporal ileal conduit (iRARC) in an ERAS setup.MethodsThis is a single-centre, double-blinded, randomised (1:1) clinical feasibility study for patients with non-metastatic high-risk non-muscle-invasive or muscle-invasive bladder cancer scheduled for cystectomy. All participants are recruited from Rigshospitalet, Denmark. The planned sample size is 50 participants to investigate whether blinding of the surgical technique is feasible. Participants and postoperative caring physicians and nurses are blinded using a pre-study designed abdominal dressing and blinding of the patient’s electronic health record. Study endpoints are assessed 90 days postoperatively. The primary aim is to study the frequency and pattern of unplanned unblinding after surgery and the number of participants who cannot guess the surgical technique at the day of discharge. Eleven secondary endpoints are assessed: length of stay, days alive and out of hospital, in-hospital complication rate, 30-day complication rate, 90-day complication rate, readmission rate, quality of life, blood loss, pain, rate of moderate/severe post-anaesthesia care unit (PACU) complications, and delirium. Participants are managed in an ERAS setup in both arms of the trial.DiscussionWe report on the design and objectives of a novel experimental feasibility study investigating whether blinding of the surgical technique in cystectomy patients is possible. This information is essential for the design of future blinded trials comparing ORC to RARC. There is a continued need to compare RARC and ORC in terms of both efficacy, safety, and oncological outcomes. Estimated end of study is March 2021.Trial registrationClinicalTrials.gov ID: NCT03977831. Registered on the 6th of June 2019.

Revisiting the Role of Amniotic Membrane Dressing in Acute Large Traumatic Wounds: A Randomized Feasibility Study at a Level 1 Trauma Centre.

Acute large traumatic wounds require temporary dressing prior to the definitive soft tissue reconstruction, as the physiological derangement during the immediate postinjury period delays the definitive surgical intervention. Selecting an ideal dressing material from numerous available synthetic dressings and skin substitutes poses a challenge. Although amniotic membrane (AM) scaffold has a definitive role in promoting wound healing in burns and chronic wounds, however, its efficacy in acute large traumatic wound is lacking. The present trial aimed to evaluate the safety and efficacy of AM in wound bed preparation before the definitive soft-tissue reconstruction in acute large traumatic wounds. Sixty patients with acute large traumatic wounds (>10 cm × 10 cm) were divided into two groups (conventional dressing and AM dressing) using simple mixed block randomization. Wounds were assessed using the Bates Jensen Score at various timelines for the signs of early wound healing. The primary outcome was to evaluate the time taken for the wound bed preparation for definitive soft-tissue reconstruction. The secondary outcome was the pain assessment and complications, if any. There was significant reduction in the wound exudate as well as peripheral tissue edema in the intervention group (P = 0.01). AM dressing was significantly less painful (P = 0.01). The incidence of wound infection and need for debridement was decreased in the intervention group. However, the time interval to definitive soft-tissue coverage was statistically insignificant and comparable in both the groups. No adverse reactions were seen in either group. AM dressings are safe and efficacious with significant reduction in wound exudates and peripheral edema. However, these dressings do not hasten the wound maturation as compared to conventional dressings. AM dressings can be used as a less painful alternative to conventional dressing in the management of large acute posttraumatic wounds.

Tailored sleep hygiene counselling in combination with diet and physical activity advice for weight reduction in an employee well-being programme: a randomised feasibility study delivered remotely

Tailored sleep hygiene counselling in combination with diet and physical activity advice for weight reduction in an employee well-being programme: a randomised feasibility study delivered remotely - Volume 82 Issue OCE1

Remote maintenance cardiac rehabilitation (MAINTAIN): A protocol for a randomised feasibility study.

Long-term adherence to exercise is often poor for people with coronary heart disease (CHD) who have completed supervised, centre-based cardiac rehabilitation. The aim of this study is to assess the feasibility of a remotely prescribed, delivered and monitored cardiac rehabilitation intervention using a wearable device to support long-term adherence to exercise and physical activity during maintenance of cardiac rehabilitation. After completing cardiac rehabilitation, 30 participants with CHD, will be randomised (1:1) to an intervention (n = 15) or a usual care group (n = 15) in a 12-month feasibility randomised controlled trial (RCT). The intervention will comprise of an exercise consultation, personalised exercise prescription delivered via a wearable activity monitor using biometric feedback, regular monitoring via check-ins, and feedback text-messages for 6-months. Participants will be assessed at baseline (following completion of cardiac rehabilitation) and at three-, six-, and 12-months post-randomisation. The primary outcome will be feasibility, including assessment of eligibility, recruitment, adherence, and acceptability. Secondary outcomes will include exercise capacity, physical activity behaviours, cardiovascular disease risk and quality of life. Semi-structured interviews will be conducted at three-, six-, and 12-months post-randomisation (and with those who drop-out) to explore the acceptability of the study intervention and procedures. A questionnaire will be offered to those who decline participation. The MAINTAIN study will evaluate the feasibility of conducting a future definitive multi-centre RCT testing a remotely prescribed and monitored long-term mHealth maintenance exercise programme, versus usual care, for people with CHD who have completed cardiac rehabilitation. ClinicalTrials.gov, NCT05292287. Registered on 22/03/2022.

A randomised feasibility study of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes (CADOM)

AimThis study aims to explore the feasibility of using serial MRI without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot, in order to decide whether a large-scale trial is warranted.MethodsA multicentre, randomised, prospective, two arm, open, feasibility study (CADOM) of people with diabetes with a suspected or confirmed diagnosis of Charcot neuroarthropathy. Participants were randomised (1:1) to ‘standard care plus’, including repeated foot temperature measurements and X-rays, or the intervention arm, with additional three-monthly MRI, until remission of Charcot neuroarthropathy or a maximum 12 months (active phase). Participants were then followed-up for a further 6 months, post remission to monitor for relapse of the Charcot neuroarthropathy (follow-up phase). Feasibility outcomes were recruitment, retention, data completeness, adherence to study procedures and safety of the intervention MRI. We also collected clinical efficacy outcomes, this included time in cast/off-loading device which will be the primary outcome of a future definitive trial. Finally, we collected patient reported outcomes, and data on health and social care usage.ResultsOne-hundred and five people were assessed for eligibility at five sites. 64/105 potential participants meet the eligibility criteria to participate in the study. Forty-three participants were randomised: 20 to standard care plus and 23 to MRI intervention. The main reason for ineligibility was a previous episode of Charcot neuroarthropathy. Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made. Of the remaining 30 participants, 19 achieved remission, 6 had not gone into remission at the end of the 12 month active phase so exited the study. Five participants were lost to follow-up. Of the MRIs that were not disrupted by COVID-19 pandemic 26/31 (84%) were completed. For the visits that were conducted face-to-face, completion rates of patient-reported outcome measures were between 71 and 100%. There were no safety incidents associated with the intervention MRI.As this was a feasibility study it was not designed to test the effectiveness of serial MRI in diagnosing remission. The time in cast/off-loading device was 235 (±108.3) days for the standard care plus arm compared to 292 (±177.4) days for the intervention arm. There was no statistical difference in the time in cast/off-loading device between the two arms of the study: Hazard Ratio (HR) 0.405 (95% CI 0.140–1.172), p = 0.096.DiscussionThe findings support a definitive randomised controlled trial to evaluate the effectiveness of MRI in diagnosing remission in Charcot neuroarthropathy. The rates of recruitment, retention, data, and MRI completeness show that a definitive study is feasible.Study registrationISRCTN, 74101606. Registered on 6 November 2017.

Flexible Training Planning Coupled with Flexible Assessment: A 12-Week Randomized Feasibility Study in a Youth Female Volleyball Team.

According to the Quality Education and Gender Equality ambitions established at the 2030 Agenda for Sustainable Development Goals, we aimed to test the feasibility of a flexible planning and assessment process, using ongoing, bidirectional feedback between planning and assessment. Eighteen players (11.5 ± 0.5 years of age) from a U13 female volleyball team were randomized into an experimental group (in which the plan could be changed daily) or a contrast group (pre-defined planning, adjusted monthly). The pedagogical intervention lasted three months. Besides ongoing daily assessments from the training practices, the Game Performance Assessment Instrument was adopted as a starting point for the weekly assessments in 4 vs. 4 game-forms (i.e., the instrument was modified monthly based on feedback from the training process). Information from daily and weekly formal assessment was used in the planning of the experimental group, and monthly in the contrast group. Data suggested that pre-established and strict planning (even updated monthly) failed to fit current learner needs. Over 12 weeks, the pre-established planning suffered regular modifications in the experimental group, and the assessment tool changed monthly. In conclusion, both planning and assessment should be open and flexible to exchange information mutually, and support the design of tailor-made learning environments.

A Feasibility Study of Individuals Living at Home with Alzheimer's Disease and Related Dementias: Utilization of Visual Mapping Assistive Technology to Enhance Quality of Life and Reduce Caregiver Burden.

Efficacy of assistive technology continues to evolve as a means of helping individuals with cognitive and intellectual disabilities, asserting the importance of its research. We report outcomes of a six-week randomized control feasibility study in a small cohort of 16 family caregivers of individuals living with Alzheimer's disease and related dementias. An experimental group of seven family caregivers used visual mapping software on smart devices (step-by-step pictures, audio, and videos instructing how to complete a task) to support carrying out activities of daily living with their care recipients. In comparison, control group of nine family caregivers used smart devices to access and view educational videos focused on dementia care. After a six-week study, compared to caregivers using educational videos, caregivers using visual maps assistive technology reported higher satisfaction of use and stronger recommendation of use to others. Caregivers using visual maps technology also exhibited more improved quality of life scores and improved completion of activities of daily living for their dementia care recipients, as well as reduced caregiver burden scores compared to the caregivers in the control group. These promising findings show that the use of assistive technology is feasible in the home setting and suggest time is ripe for undertaking systematic studies of assistive technology's potential to advance effective behavioral interventions in dementia home and family settings.

Enhancing self-esteem through cognitive behavioural group therapy - a randomized feasibility study of a transdiagnostic approach in psychiatric care

• The majority of psychiatric patients complain about severely disturbed self-esteem • The enhancement of self-esteem is one of the major therapeutic goals for patients • Self-esteem CB group offers an effective, transdiagnostic and economic treatment • Self-esteem interventions should be integrated as standard in inpatient psychiatry Working with patients with mental disorders, one most likely comes across a common ground: self-esteem issues. In view of the high cross-diagnostic relevance, it is surprising that psychotherapeutic group treatments mostly treat self-esteem as a marginal topic. A promising treatment opportunity in psychiatry might have been neglected. We developed a 12-session cognitive behavioral group therapy module to treat low self-esteem in a diagnostically mixed group of psychiatric inpatients (average age: 43,31 years, 60,78% female), the affective disorder category forming the largest portion of our sample, who were randomly assigned: 61 patients participated in the intervention group in addition to treatment‐as‐usual (TAU) and 41 served as controls by receiving TAU. The MANOVA not only showed a significant improvement in self-esteem and depression scores within the intervention group over the course but also in comparison to the control group. The aim of a broad application of the group therapy concept under realistic clinical conditions requires the inclusion of patients with various disorders and treatment plans and therefore an acceptance of a high sample heterogeneity. High external validity is often at the expense of internal validity, even with the review of possible confounding variables. Furthermore, long-term effects of the training are yet to be investigated. Self-esteem issues represent a topic that unites a large group of patients and therefore offers a promising cross-diagnostical approach. The group module appears to be effective in a heterogonous patient population and promises an effective economic therapy approach and could therefore be integrated in the clinical standard of psychiatric inpatient treatments.

A Technology-Augmented Intervention to Promote Self-Management Self-Efficacy among Persons with Stroke: A Pilot Feasibility Study

<h3>Research Objectives</h3> To determine the feasibility and the initial effect of a technology-augmented intervention to improve self-management self-efficacy in persons with stroke. <h3>Design</h3> A three-month randomized feasibility study. <h3>Setting</h3> Community. <h3>Participants</h3> Twenty-four individuals (42% female, 38% black, 54% married, 71% mild severity, 83% Ischemic stroke) with chronic stroke (control arm = 13, intervention arm = 11) were recruited. <h3>Interventions</h3> Participants in the intervention group received the iSMART (interactive Self-Management Augmented Rehabilitation Technologies). The iSMART is an adjunctive behavioral intervention technology composed of skills training, coaching, and text messaging for improved self-management of chronic conditions and the use of participation strategies in persons after stroke. Participants in the control group received stroke-specific educational materials and phone calls without iSMART content. <h3>Main Outcome Measures</h3> Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure, PROMIS Self-Efficacy for Managing Chronic Conditions, and Participation Strategies Self-Efficacy Scale. <h3>Results</h3> Two iSMART participants withdrew from the study, resulting in an overall retention rate of 82%. Participants responded to 78% of all messages received. The iSMART group had higher feasibility (d = .449), acceptability (d = .505), and appropriateness (d = .540) than the control group. The iSMART group showed moderate to large effects (d = .494 to .870) in improving self-efficacy in managing emotions, symptoms, daily activities, and treatments and medications. The iSMART also showed moderate effects (d = .554 to .673) in improving self-efficacy in using participation strategies for home, community, and work activities. The control group demonstrated small effects in these outcomes. <h3>Conclusions</h3> The iSMART is a feasible and effective intervention to improve the self-efficacy of persons with stroke for managing chronic conditions and using strategies to support participation. <h3>Author(s) Disclosures</h3> None disclosed.

Eye-tracking to observe compliance with hand hygiene in the intensive care unit: a randomized feasibility study

Healthcare-associated infections are associated with increased patient mortality. Hand hygiene is the most effective method to reduce these infections. Despite simplification of this easy intervention, compliance with hand disinfection remains low. Current assessment of hand hygiene is mainly based on observation by hygiene specialists. The aim of this study was to investigate additional benefits of eye-tracking during the analysis of hand hygiene compliance of healthcare professionals in the intensive care unit. In a simulated, randomized crossover study conducted at the interdisciplinary intensive care unit at University Hospital Zurich, Switzerland, doctors and nurses underwent eye-tracking and completed two everyday tasks (injection of 10μg norepinephrine via a central venous line, blood removal from the central line) in two scenarios where the locations of alcoholic dispensers differed ('in-sight' and 'out-of-sight'). The primary outcomes were dwell time, revisits, first fixation duration and average fixation duration on three areas of interest (central venous line, alcohol dispenser, protective glove box) for both scenarios. Compliance with hand hygiene guidelines was analysed. Forty-nine participants (35 nurses, 14 doctors) were included in this study. Eye-tracking provided additional useful information compared with conventional observations. Dwell time, revisits, first fixation duration and average fixation duration did not differ between the two scenarios for all areas of interest. Overall compliance with recommended hand hygiene measures was low in both doctors (mean 20%) and nurses (mean 42.9%). Compared with conventional observations, eye-tracking offered additional helpful insights and provided an in-depth analysis of gaze patterns during the recording of hand hygiene compliance in the intensive care unit.

A cross-over, randomised feasibility study of digitally printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S - a study protocol

Background/objectives: Around 11,500 artificial eyes are required yearly for new and existing patients. Artificial eyes have been manufactured and hand-painted at the National Artificial Eye Service (NAES) since 1948, in conjunction with approximately 30 local artificial eye services throughout the country. With the current scale of demand, services are under significant pressure. Manufacturing delays as well as necessary repainting to obtain adequate colour matching, may severely impact a patient’s rehabilitation pathway to a normal home, social and work life. However, advances in technology mean alternatives are now possible. The aim of this study is to establish the feasibility of conducting a large-scale study of the effectiveness and cost-effectiveness of digitally printed artificial eyes compared to hand-painted eyes. Methods: A cross-over, randomised feasibility study evaluating a digitally-printed artificial eye with a hand-painted eye, in patients aged ≥18 years with a current artificial eye. Participants will be identified in clinic, via ophthalmology clinic databases and two charity websites. Qualitative interviews will be conducted in the later phases of the study and focus on opinions on trial procedures, the different artificial eyes, delivery times, and patient satisfaction. Discussion: Findings will inform the feasibility, and design, of a larger fully powered randomised controlled trial. The long-term aim is to create a more life-like artificial eye in order to improve patients’ initial rehabilitation pathway, long term quality of life, and service experience. This will allow the transition of research findings into benefit to patients locally in the short term and National Health Service wide in the medium to long term. ISRCTN registration: ISRCTN85921622 (17/06/2021)

A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol

BackgroundApproximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist ‘Tier 3’ Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity.MethodsThis feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted.DiscussionThis randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients.Trial registrationISRCTN number 22088800.

A trial of intra-pleural bacterial immunotherapy in malignant pleural mesothelioma (TILT) — a randomised feasibility study using the trial within a cohort (TwiC) methodology

BackgroundMalignant pleural mesothelioma (MPM) is an aggressive thoracic malignancy with a poor prognosis. Systemic immunotherapy is an effective frontline treatment for MPM, and there is a scientific rationale supporting the possible efficacy of local, i.e. intra-pleural immune modulators. Trial of intra-pleural bacterial immunotherapy (TILT) investigated the feasibility of performing a randomised trial of intra-pleural bacterial immunotherapy in people with MPM, using the trials within cohorts (TwiC) methodology.MethodsTILT was a multicentre, three-armed, randomised, feasibility TwiC of intra-pleural OK432, BCG, or usual care in people with MPM. Eligible participants were identified from within the ASSESS-meso study, a prospective, longitudinal, observational cohort study, and were randomly selected to be offered a single dose of OK432 or BCG, via an indwelling pleural catheter. The primary outcome was feasibility, evaluated against prespecified recruitment, attrition and data completeness targets. The acceptability of trial processes and interventions was assessed during qualitative interviews with participants and family members at the end of the trial. TILT was registered prospectively on the European Clinical Trials Registry (EudraCT number 2016–004,727-23) and the ISRCTN Register on 04 December 2017.ResultsSeven participants were randomised from a planned sample size of 12; thus, the 66% recruitment rate target was not met. Two participants withdrew after randomisation, breaching the pre-stated attrition threshold of 10%. It was not possible to maintain blinding of control participants, which negated a fundamental tenet of the TwiC design. The trial processes and methodology were generally acceptable to participants and relatives, despite several recipients of intra-pleural bacterial agents experiencing significant local and systemic inflammatory responses.ConclusionIt was possible to design a clinical trial of an investigational medicinal product based on the TwiC design and to obtain the necessary regulatory approvals. However, whilst acceptable to participants and relatives, the TwiC design was not a feasible method of investigating intra-pleural bacterial immunotherapy in people with MPM. Future trials investigating this topic should consider the eligibility constraints and recruitment difficulties encountered.Trial registrationTILT was registered prospectively on the European Clinical Trials Registry (EudraCT number 2016-004727-23) and the ISRCTN Register (10432197) on 04 December 2017.

Development of a prediction model to determine responders to conservative treatment in people with symptomatic hand osteoarthritis: A secondary analysis of a single-centre, randomised feasibility trial

BackgroundConservative treatments are beneficial for people with hand osteoarthritis (OA). ObjectiveIt was the purpose of this study to develop and internally validate both a basic model and a more complex model that could predict responders to conservative treatments in people with hand OA. DesignThis was a secondary analysis of a single-centre, randomised feasibility study. MethodsFifty-nine participants (34 responders) with hand osteoarthritis were recruited from the general population. Participants were randomised to receive either advice alone, or advice in combination with blood flow restriction training (BFRT), or traditional high intensity training (HIT). Participants underwent supervised hand exercises three times per week for six weeks. The OMERACT-OARSI criteria were utilised to determine responders vs non responders to treatment at the end of six weeks. A basic logistic regression model (treatment type, expectations, adherence) and a more complex logistic regression model (basic model variables plus pain catastrophising and neuropathic pain features) were created. Discrimination ability, and calibration were assessed. Internal model validation through bootstrapping (200 repetitions) was utilised to calculate the prediction model optimism. ResultsThe results showed that the basic model presented with acceptable discrimination (optimism corrected c-statistic: 0.72, 95% CI 0.71–0.73) and calibration (slope = 1.41; intercept = 0.68). The more complex model had better discrimination but poorer calibration. ConclusionA prediction tool was created to provide an individualised estimate of treatment response in people with hand OA. Future studies will need to validate this model in other groups of patients. Trial registrationhttps://www.anzctr.org.au/- ACTRN12617001270303.

Using a discrete choice experiment to develop a decision aid tool to inform the management of persistent pain in pharmacy: a protocol for a randomised feasibility study

IntroductionIn an era of personalised healthcare, it has become increasingly important to elicit individual-level preferences. While discrete choice experiments (DCEs) are widely used to measure patient preferences in the delivery...