RAPTOR: Randomised Controlled Trial of PENTOCLO (pentoxifylline-tocopherol-clodronate) in Mandibular Osteoradionecrosis-study protocol for an open-label phase II randomised controlled superiority trial.

Background: Mandibular osteoradionecrosis (ORN) is a severe late radiation toxicity affecting 5-10% of patients who receive radiotherapy as part of treatment for head and neck malignancy. ORN can cause permanent disfigurement, dysfunction, pain and infection. There remains little robust evidence supporting the efficacy of medical or surgical management currently offered in clinical practice.

Exercise rehabilitation with tailored support for exercise adherence for people with vertebral fragility fractures is more effective than standard rehabilitation: the OPTIN randomised controlled trial.

Unlabelled: This study assessed the effect of adding an adherence support intervention to exercises for vertebral fragility fractures. The findings showed the intervention group demonstrated significantly better outcomes for Timed-up and Go test and 6 min walk test. Additional support for exercise behaviour provided greater benefits than exercise alone.

Meeting of minds: imagining the future of child and youth mental health research from an early career perspective.

Child and youth mental health is an international public health and research priority. We are an interdisciplinary and cross-sectoral network of UK-based early career researchers (ECRs) with an interest in child and youth mental health research. In this paper, we reflect on ongoing challenges and areas for growth, offering recommendations for key stakeholders in our field, including researchers, institutions and funders.

Higher hospital volume reduces early failure rates in single-stage revision TKR for infection: An analysis of the United Kingdom National Joint Registry and National Administrative Databases.

Purpose: Revision knee replacement (RevKR) for infection is rare but increasing. It is hypothesised that higher hospital volume reduces adverse outcomes. The aim was to estimate the association of surgical unit volume with outcomes following first, single-stage RevKR for infection.

Five-year outcomes for patients sustaining severe fractures of the lower limb from the Wound Healing in Surgery for Trauma (WHIST) trial.

Aims: The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial.

Methods: The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement.

Cost-effectiveness analysis of soft bandage and immediate discharge versus rigid immobilization in children with distal radius torus fractures.

Aims: The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius.

Methods: A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires.

Selecting a randomization method for a multi-center clinical trial with stochastic recruitment considerations.

Background: The design of a multi-center randomized controlled trial (RCT) involves multiple considerations, such as the choice of the sample size, the number of centers and their geographic location, the strategy for recruitment of study participants, amongst others. There are plenty of methods to sequentially randomize patients in a multi-center RCT, with or without considering stratification factors. The goal of this paper is to perform a systematic assessment of such randomization methods for a multi-center 1:1 RCT assuming a competitive policy for the patient recruitment process.

A multidimensional assessment of payback: Evaluating the impact of Breast Cancer Trials.

Aim: This study evaluates the impact created by clinical trial investment and research undertaken by Breast Cancer Trials (BCT).

Methods: The approach involved using the Payback Framework, and included a review of BCT archival information, public health data, a questionnaire sent to BCT members, individual interviews with key informants, a focus group with members of the organization's Consumer Advisory Panel, and case studies of select BCT trials. The evaluation assessed the evidence against the Payback Framework criteria: informing policy and product development, knowledge production, the research system, health and health sector benefits, and broader economic benefits.

Epidemiology of revision hip replacement surgery in the UK over the past 15 years-an analysis from the National Joint Registry.

Objectives: To investigate trends in the incidence rate and main indication for revision hip replacement (rHR) over the past 15 years in the UK.

Design: Repeated national cross-sectional study from 2006 to 2020.

Setting/participants: rHR procedures were identified from the National Joint Registry for England, Wales, Northern Ireland, the Isle of Man and the States of Guernsey.

Do selfies make women look slimmer? The effect of viewing angle on aesthetic and weight judgments of women's bodies.

Taking and posting selfies is a popular activity, with some individuals taking and sharing multiple selfies each day. The influence of the selfie angle, as opposed to more traditional photo angles such as the allocentric images we see in print media, on our aesthetic judgements of images of bodies has not been explored. This study compared the attractiveness and weight judgements that participants made of images of the same bodies taken from different visual angles over a series of four experiments (total N = 272).

Patient-Relevant Outcomes Following First Revision Total Knee Arthroplasty, by Diagnosis: An Analysis of Implant Survivorship, Mortality, Serious Medical Complications, and Patient-Reported Outcome Measures Utilizing the National Joint Registry Data Set.

Background: The purpose of this study was to investigate patient-relevant outcomes following first revision total knee arthroplasties (rTKAs) performed for different indications.

Methods: This population-based cohort study utilized data from the United Kingdom National Joint Registry, Hospital Episode Statistics Admitted Patient Care, National Health Service Patient-Reported Outcome Measures, and the Civil Registrations of Death. Patients undergoing a first rTKA between January 1, 2009, and June 30, 2019, were included in our data set.

Duroplasty for injured cervical spinal cord with uncontrolled swelling: protocol of the DISCUS randomized controlled trial.

Background: Cervical traumatic spinal cord injury is a devastating condition. Current management (bony decompression) may be inadequate as after acute severe TSCI, the swollen spinal cord may become compressed against the surrounding tough membrane, the dura. DISCUS will test the hypothesis that, after acute, severe traumatic cervical spinal cord injury, the addition of dural decompression to bony decompression improves muscle strength in the limbs at 6 months, compared with bony decompression alone.

Exploring the effects of gender and sexual orientation on disordered eating: an EFA to CFA study of the Eating Disorder Examination Questionnaire.

Several problems limit our understanding of the ways that gender and sexual orientation influence disordered eating. These include the reliance on measures that have been developed and validated in samples of cisgender heterosexual women, and the lack of confirmed measurement invariance that allows us to meaningfully compare these experiences between groups. This study was an EFA to CFA exploration of the Eating Disorder Examination Questionnaire in a group of heterosexual, bisexual, gay, and lesbian men and women.

Assessing a 12-month course of oral alendronate for adults with avascular necrosis of the hip: MANTIS RCT with internal pilot.

Background: People with avascular necrosis of the hip have very limited treatment options currently available to stop the progression of this disease; this often results in the need for a hip replacement. There is some weak evidence that a class of drugs called bisphosphonates may delay the course of the disease, and this trial was commissioned and set up to provide robust evidence regarding the use of bisphosphonates in adults aged ≥ 18 years with this condition.

Objectives: The aim of the Managing Avascular Necrosis Treatments: an Interventional Study ( MANTIS ) trial was to evaluate the clinical effectiveness and cost-effectiveness of a 12-month course of alendronate in the treatment of avascular necrosis.

Radiological malunion after ankle fractures in older adults : definitions and new thresholds derived from clinical outcome data from the AIM trial.

Aims: The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence.

Methods: Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years.

Borrowing strength from clinical trials in analysing longitudinal data from a treated cohort: investigating the effectiveness of acetylcholinesterase inhibitors in the management of dementia.

Background: Health care professionals seek information about effectiveness of treatments in patients who would be offered them in routine clinical practice. Electronic medical records (EMRs) and randomized controlled trials (RCTs) can both provide data on treatment effects; however, each data source has limitations when considered in isolation.

Methods: A novel modelling methodology which incorporates RCT estimates in the analysis of EMR data via informative prior distributions is proposed.

Physiotherapy exercise rehabilitation with tailored exercise adherence support for people with osteoporosis and vertebral fractures: protocol for a randomised controlled trial - the OsteoPorosis Tailored exercise adherence INtervention (OPTIN) study.

Introduction: Vertebral fragility fractures affect at least 20% of the older population in the UK. Best practice guidelines recommend the use of exercise to slow the rate of bone loss, to maintain muscle strength and physical function, and to prevent falls and further fractures. However, treatment effects are often small and difficult to sustain and adherence, or the extent to which patients engage in treatment, has been identified as an important issue by many studies.

Offer of a bandage versus rigid immobilisation in 4- to 15-year-olds with distal radius torus fractures: the FORCE equivalence RCT.

Background: Torus (buckle) fractures of the wrist are the most common fractures in children involving the distal radius and/or ulna. It is unclear if children require rigid immobilisation and follow-up or would recover equally as well by being discharged without any immobilisation or a bandage. Given the large number of these injuries, identifying the optimal treatment strategy could have important effects on the child, the number of days of school absence and NHS costs.

Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK.

Background: The most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol.

Early patient-reported outcomes from primary hip and knee arthroplasty have improved over the past seven years : an analysis of the NHS PROMs dataset.

Aims: Routinely collected patient-reported outcome measures (PROMs) have been useful to quantify and quality-assess provision of total hip arthroplasty (THA) and total knee arthroplasty (TKA) in the UK for the past decade. This study aimed to explore whether the outcome following primary THA and TKA had improved over the past seven years.

Methods: Secondary data analysis of 277,430 primary THAs and 308,007 primary TKAs from the NHS PROMs programme was undertaken.

Economic outcomes associated with deep surgical site infection from lower limb fractures following major trauma.

Aims: This study aims to estimate economic outcomes associated with 30-day deep surgical site infection (SSI) from closed surgical wounds in patients with lower limb fractures following major trauma.

Methods: Data from the Wound Healing in Surgery for Trauma (WHiST) trial, which collected outcomes from 1,547 adult participants using self-completed questionnaires over a six-month period following major trauma, was used as the basis of this empirical investigation. Associations between deep SSI and NHS and personal social services (PSS) costs (£, 2017 to 2018 prices), and between deep SSI and quality-adjusted life years (QALYs), were estimated using descriptive and multivariable analyses.