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Multicentre, adaptive, double-blind, three-arm, placebo-controlled, non-inferiority trial examining antimicrobial prophylaxis duration in cardiac surgery (CALIPSO): trial protocol

Por: Peel · T. · McGiffin · D. · Smith · J. · Forbes · A. · Marasco · S. · Pilcher · D. · Stewardson · A. J. · Petrie · D. · Peleg · A. Y. · Wisniewski · J. · Forster · S. · Druce · P. · Roney · J. · Astbury · S. · Berkovic · D. · Mccracken · P. · Myles · P. S. · on behalf of the CALIPSO Tria
Introduction

Administration of antibiotics before incising the skin (‘surgical antimicrobial prophylaxis’) is a critical infection prevention strategy in surgery. Extending doses of prophylaxis into the postoperative period is a common practice in cardiac surgery; however, the benefit has not been clearly established and may lead to emergence of antimicrobial resistance and patient harm. We present the protocol for a large international multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial to compare the incidence of surgical site infection after three different durations of postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery.

Methods and analysis

This adaptive, multi-arm multistage non-inferiority trial will compare intraoperative only (Arm A), to intraoperative and 24 hours (Arm B) and, to intraoperative and 48 hours (Arm C) of intravenous cefazolin and placebo as surgical antimicrobial prophylaxis in 9180 patients undergoing cardiac surgery. The adaptive design allows for potential dropping of any of the three arms if clear inferiority is indicated at any of the scheduled interim analyses. The trial will evaluate the clinical and cost-effectiveness of the three different antibiotic prophylaxis durations.

Ethics and dissemination

Ethics approval will be obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. Patients and members of the public will also be involved in the dissemination and translation of the trial results.

Trial registration number

NCT05447559.

Can we enhance neurorehabilitation through regional implementation of group-based telerehabilitation? A mixed-methods evaluation of NeuroRehabilitation OnLine (NROL)

Por: Ackerley · S. · Mason · T. · Partington · A. · Peel · R. · Vernon · H. · Connell · L.
Objectives

To determine whether neurorehabilitation can be enhanced through regional implementation of group-based telerehabilitation, we implemented the NeuroRehabilitation OnLine (NROL) innovation regionally and evaluated scale-up from a systems perspective.

Design

Observational, exploratory service evaluation using a mixed-methods convergent parallel design.

Setting

Stroke and neurological rehabilitation services from four organisations across a regional healthcare system in the UK.

Participants

Therapy staff from community-based services and patients with a stroke or neurological condition receiving active community rehabilitation including NROL from April 2022 to March 2024.

Intervention

A regional multidisciplinary group-based neurological telerehabilitation innovation (NROL).

Outcome measures

Selected Proctor’s implementation outcomes, to establish system-level adoption, acceptability and sustainability of the regional NROL innovation.

Results

NROL was adopted by all intended organisations and continues as part of usual care with participation growing. It was acceptable to therapy staff and patients across the region, well-used, valued and supported increased therapy provision. For sustainability, staffing and travel efficiencies were identified through effective collaborative regional systems working. The importance of continued wide stakeholder engagement, robust evaluation and alignment was highlighted.

Conclusions

NROL was successfully embedded into real-world practice at a system level and enhanced neurorehabilitation. Looking forward, longer-term sustainment of this innovation will require a compelling business case and value proposition for decision-makers, addressing economic, equality and operational efficiency considerations.

Contemporary, postpandemic description of UK occupational therapy and physiotherapy practice to rehabilitate the upper limb after stroke: the SUPPLES 2 online survey

Por: Jarvis · K. A. · Connell · L. · Peel · R. · Stockley · R. C.
Objectives

To provide a contemporary, postpandemic description of UK occupational therapy and physiotherapy practice to rehabilitate the upper limb after stroke.

Setting

A national online survey, first undertaken in 2018 (prepandemic), was readministered to describe postpandemic practice.

Participants

The survey was distributed to UK-based occupational therapists and physiotherapists working with people after stroke, via professional and social networks.

Primary measures

Shaped by the Template for Intervention Description and Replication Checklist, the survey collected and subsequently analysed the content, frequency and duration of upper limb rehabilitation after stroke.

Results

A total of 122 occupational therapists (n=42) and physiotherapists (n=80) currently working clinically, across in-patient, out-patient and community settings, in the UK completed the survey. Respondents reported treating the upper limb a median of three times a week (IQR 2–4; range 0–6) for a median of 25 min (IQR: 20–35; range 3–60; n=119). Repetitive, functionally-based activities were the most commonly reported interventions for mild (n=93; 81%) and moderate (n=72; 64%) impairment. Stretching (n=73; 66%) and positioning (n=49; 45%) were most frequently reported for severe impairment. In each of the three impairment categories, a larger number of interventions were reported than in the 2018 survey.

Conclusions

While the pandemic promoted the use of virtual interventions, most therapists had returned to face-to-face interventions. The findings highlight that the current reported provision of upper limb therapy continues to be markedly less than the dose shown to be effective. The study provides important data which can be used to judge the success of attempts to align practice with new guidelines and inform ‘usual therapy’ for the upper limb after stroke in comparative studies.

Real-world waitlist randomised controlled trial of gameChange VR to treat severe agoraphobic avoidance in patients with psychosis: a study protocol

Por: Freeman · D. · Jones · J. · Prouten · E. · Sainsbury · J. · Morrison · A. · Chapman · K. · Cousins · E. · Altoft · V. · Peel · H. · Kabir · T. · Myrick · J. · Rovira · A. · Rouse · N. · Waite · F. · Lambe · S. · Leal · J. · Yu · L.-M.
Introduction

Many people with psychosis find the world very frightening. It can be difficult for them to do everyday things—for example, walking down a busy street, travelling on a bus or going to the shops. Sometimes, the fears are so great that individuals rarely leave their homes. gameChange virtual reality therapy is designed to reduce this agoraphobic avoidance. In gameChange, users practise going into computerised immersive versions of ordinary situations. A virtual therapist guides users through the programme. A mental health worker also supports people. People normally do six sessions of gameChange, but now they can do more as headsets can be left with many people. We originally tested gameChange with 346 patients with psychosis. People saw a significant reduction in their fears. People with the most severe problems made the biggest improvements. This led to gameChange receiving National Institute for Health and Care Excellence (NICE) Early Value Assessment (EVA) approval for its use with patients with psychosis who have severe agoraphobic avoidance. NICE EVA approval is conditional on further evidence generation. We aim to carry out a real-world trial of gameChange used in the NHS. The overall aim is to gather evidence on the four essential areas (clinical benefits on agoraphobia, level of engagement and adherence, healthcare resource use, adverse effects) and the two further supporting areas (health-related quality of life, generalisability) identified in the NICE evidence generation plan for gameChange.

Methods and analysis

200 patients with psychosis and severe agoraphobic avoidance will be randomised (1:1) to receive gameChange in addition to treatment as usual (TAU) or to a waitlist control group receiving TAU. Assessments will be conducted blind to group allocation at baseline, 8 weeks (end of treatment) and 26 weeks (follow-up). The trial will be embedded in services in at least seven National Health Service (NHS) trusts across England. The primary outcome is agoraphobic avoidance at 26 weeks assessed with the Oxford Agoraphobic Avoidance Scale. The secondary clinical outcomes are agoraphobic distress, paranoia and social contacts. There will be tests of moderation of the main clinical outcome. Treatment acceptability, adverse effects and cost-effectiveness will also be assessed. The target estimand is the treatment policy estimand and all primary and secondary analyses will be carried out incorporating data from all participants including those who do not complete treatment.

Ethics and dissemination

The trial has received ethical approval from the NHS Health Research Authority and Health and Care Research Wales (25/WA/0081). A key output will be the evidence needed for a NICE guidance update on gameChange and a clear recommendation concerning future routine use in the NHS.

Trial registration number

ISRCTN79060696.

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