Early Laser for Burn Scars (ELABS): protocol for a multi-centre randomised, controlled trial of both the effectiveness and cost-effectiveness of the treatment of hypertrophic burn scars with Pulsed Dye Laser and standard care compared to standard care alone [version 1; peer review: 2 approved]

This paper outlines the protocol for a study that is being carried out at multiple centres across the UK in the next three years. It is a Research for Patient Benefit (RfPB) study funded by the National Institute for Healthcare Research (NIHR). The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation.  The objective is to improve Quality of Life for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological impact. This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone.  The difference is measured between baseline and six-month follow-up. Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm.  The treatment arm receives 3 PDL treatments at six-week intervals in addition to standard care, whereas the control arm receives standard care alone.  The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS).  Psychological and psycho-social impact is evaluated using the CARe burn scale (UWE, Bristol) and Quality Adjusted Life Years (QALY) is determined using the Short-Form Health Survey (SF-12). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews. Trial registration: ISRCTN14392301 (registered on 14th June 2021) Contact for Public & Scientific Queries: Mark Brewin, [email protected]   Public Title: Early Laser for Burn Scars (ELABS): a trial of the effectiveness and cost of the treatment of hypertrophic burn scars with laser Countries of Recruitment: England & Scotland Protocol Version: v11, October 202

Where do we go from here? - Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals

BackgroundClinical trials commonly have a dedicated trial manager and effective trial management is essential to the successful delivery of high-quality trials. Trial managers have diverse experience and currently there is no standardised structured career pathway. The UK Trial Managers’ Network (UKTMN) surveyed its members to understand what is important to them with respect to career development since this would be important in the development of any initiative intended to develop a skilled workforce.MethodsWe conducted an online survey of UKTMN members, who are trial management professionals, working on academic-led trials in the UK. Members were asked what they perceive as opportunities and barriers to career development. Two reminders were sent to facilitate completion of the survey, and responders were offered the opportunity to enter a prize draw for waived fees at the UKTMN annual meeting. Data were analysed descriptively by using Stata (version 15.1), and free-text responses were reviewed for themes.ResultsThe survey was sent to 819 UKTMN members; 433 responses were received, although 13 were from non-UKTMN members; thus 420 respondents' data were included in analyses. Respondents were representative of UKTMN membership; however, more responses were received by trial managers based in registered clinical trials units (CTUs). The top three opportunities for career development were (i) training, (ii) helping design trials and (iii) undertaking relevant qualifications. The top three barriers were (i) funding, (ii) few opportunities to get involved in development activities aside from managing a trial and (iii) unclear organisational career pathway. Almost all respondents (401/420, 95.4%) considered career development either very or quite important. Although all respondents had a day-to-day role in managing trials, there was huge disparity between job titles.ConclusionCareer development is important to trial managers yet there is a lack of a structured pathway. The enablers and disablers to career development for trial managers should be clearly considered by the clinical trial community and, in particular, employers, sponsors and funders in order to develop a highly skilled workforce of trial managers, who are key to the delivery of trials

Early Laser for Burn Scars (ELABS): protocol for a multi-centre randomised, controlled trial of both the effectiveness and cost-effectiveness of the treatment of hypertrophic burn scars with Pulsed Dye Laser and standard care compared to standard care alone [version 1; peer review: 2 approved].

This paper outlines the protocol for a study that is being carried out at multiple centres across the UK in the next three years. It is a Research for Patient Benefit (RfPB) study funded by the National Institute for Healthcare Research (NIHR). The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation. The objective is to improve Quality of Life for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological impact. This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone. The difference is measured between baseline and six-month follow-up. Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm. The treatment arm receives 3 PDL treatments at six-week intervals in addition to standard care, whereas the control arm receives standard care alone. The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS). Psychological and psycho-social impact is evaluated using the CARe burn scale (UWE, Bristol) and Quality Adjusted Life Years (QALY) is determined using the Short-Form Health Survey (SF-12). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews

Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): Study protocol for a multi-centre randomised controlled trial

Background: With an increasing number of people with dementia worldwide and limited advancement in medical treatments, the call for new and cost-effective approaches is crucial. The utility of self-management has been proven in certain chronic conditions. However, very little work has been undertaken regarding self-management in people with dementia. Methods: The SHAPE trial will include 372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners. The study is a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm is compared with treatment as usual. The intervention comprises a 10-week course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the nature of the condition and the development of healthy behaviours in a supportive learning environment. An e-learning course will be provided for care partners which covers similar and complementary material to that discussed in the group sessions for the participant with dementia. Discussion: This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia. Trial registration: ClinicalTrials.gov Identifier: NCT04286139, registered prospectively February 26, 2020, https://clinicaltrials.gov/ct2/show/NCT0428613

Environmental Scan: Metro Regional Report

In 2010, the Extension Center for Family Development of the University of Minnesota launched a project to learn more about the current and future issues affecting families in Minnesota. During this environmental scan project, community-level interviews were conducted in 11 different regions of the state. This report summarizes the community-level interviews conducted in metro Minnesota. University of Minnesota Extension Center for Family Development staff members — Ali Shurilla, Mary Marczak, Jon Fu, and Heather Lee — assisted in the development of this report.This archival publication may not reflect current scientific knowledge or recommendations. Current information available from the University of Minnesota Extension: https://www.extension.umn.edu