Risk factors associated with the development of complications after a hip fracture.

Aims: Mortality after a hip fracture has declined in recent years, but the risk of complications remains high. The aim of this study was to identify non-modifiable and, specifically, modifiable factors associated with the development of complications after hip fracture.

Methods: This was a multicentre, prospective cohort study of adults aged ≥ 60 years with a hip fracture who were treated in 77 hospitals in England, Wales, and Northern Ireland between July 2014 and November 2021.

Alternative designs for randomized clinical trials : where are we now with the World Hip Trauma Evaluation (WHiTE) platform trial?

Hip fractures present some of the biggest challenges facing patients and healthcare systems. Worldwide, there are currently 1.3 million hip fractures per year, projected to rise to more than six million by 2050.

Progressive resistance and flexibility exercises versus usual care advice for improving pain and function after distal radius fracture in adults aged 50 years or over : protocol for the WISE randomized superiority trial.

Aims: Distal radius fractures are very common injuries; the majority affect females aged 50 years or over. Most patients experience pain and stiffness in their wrist and upper limb weakness, making activities of daily living difficult. The aim of the WISE (Wrist Injury Strengthening Exercise) trial is to assess the effectiveness of a flexibility and resistance exercise programme for the upper limb compared with usual care advice after distal radius fracture.

The protocol for a multicentre prospective randomized noninferiority trial of surgical reduction versus non-surgical casting for displaced distal radius fractures in children : Children's Radius Acute Fracture Fixation Trial (CRAFFT) protocol.

Aims: The remarkable capacity for distal radius fractures in children to remodel raises questions about the necessity and extent of the intervention required to achieve anatomical alignment. The British Society of Children's Orthopaedic Surgery prioritized this uncertainty as one of their most important research questions. This is the protocol for a randomized, controlled, multicentre, prospective, noninferiority trial of non-surgical casting versus surgical reduction for severely displaced fractures of the distal radius in children: the Children's Radius Acute Fracture Fixation Trial.

The World Hip Trauma Evaluation (WHiTE) platform trial: a framework for randomized comparisons of interventions for fragility hip fracture.

Aims: Hip fracture is one of the biggest challenges facing patients and healthcare systems. Worldwide, there are currently 1.3 million hip fractures per year, projected to rise to more than six million by 2050.

The risk of complications after hip fracture.

Aims: The risk of mortality after a hip fracture has been extensively investigated, but there is little high-quality information available dealing with the overall risk of complications. The aim of this study was to report the risk of complications in the first 120 days after a hip fracture.

Methods: This was a multicentre, prospective cohort study of patients aged > 60 years with a hip fracture, involving 77 hospitals in England, Wales, and Northern Ireland, between January 2015 and 2022.

Developing generic clinical trial animated explainer videos in the UK: results of a survey and case study.

Background: Animated short videos used to explain a concept or project are often called animated explainer videos (AEVs). AEVs can supplement or provide an alternative to participant information sheets as a means of giving information about clinical research to potential participants. Current use of AEVs tends to focus on the specifics of a particular trial, yet there are many common aspects of clinical research regardless of the interventions being investigated that can be poorly covered in current trial materials.

Effectiveness of supervised versus self-directed rehabilitation for adults aged 50 years and over with ankle fractures: protocol for the AFTER trial.

Aims: Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Early versus delayed weight-bearing following operatively treated ankle fracture (WAX): a non-inferiority, multicentre, randomised controlled trial.

Background: After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early weight-bearing) might be a safe and preferable rehabilitation strategy. This study aimed to determine the clinical and cost effectiveness of an early weight-bearing strategy compared with a delayed weight-bearing strategy.

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.

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK.

Background: Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. The range of media technology used to deliver this material is expanding rapidly but is highly fragmented.

Effect of a 2-week interruption in methotrexate treatment on COVID-19 vaccine response in people with immune-mediated inflammatory diseases (VROOM study): a randomised, open label, superiority trial.

Background: Methotrexate is the first-line treatment for immune-mediated inflammatory diseases and reduces vaccine-induced immunity. We evaluated if a 2-week interruption of methotrexate treatment immediately after COVID-19 booster vaccination improved antibody response against the S1 receptor binding domain (S1-RBD) of the SARS-CoV-2 spike protein and live SARS-CoV-2 neutralisation compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases.

Method: We did a multicentre, open-label, parallel-group, randomised, superiority trial in secondary-care rheumatology and dermatology clinics in 26 hospitals in the UK.

Service availability and readiness for hip fracture care in low- and middle-income countries in South and Southeast Asia.

Aims: The aim of this study was to describe the current pathways of care for patients with a fracture of the hip in five low- and middle-income countries (LMIC) in South Asia (Nepal and Sri Lanka) and Southeast Asia (Malaysia, Thailand, and the Philippines).

Methods: The World Health Organization Service Availability and Readiness Assessment tool was used to collect data on the care of hip fractures in Malaysia, Thailand, the Philippines, Sri Lanka, and Nepal. Respondents were asked to provide details about the current pathway of care for patients with hip fracture, including pre-hospital transport, time to admission, time to surgery, and time to weightbearing, along with healthcare professionals involved at different stages of care, information on discharge, and patient follow-up.

Physiotherapy Rehabilitation Post Patellar Dislocation (PRePPeD)-protocol for an external pilot randomised controlled trial and qualitative study comparing supervised versus self-managed rehabilitation for people after acute patellar dislocation.

Background: Patellar dislocations mainly affect adolescents and young adults. After this injury, patients are usually referred to physiotherapy for exercise-based rehabilitation. Currently, limited high-quality evidence exists to guide rehabilitation practice and treatment outcomes vary.

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.

Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT).

Objectives: To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.

Design: Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.

Setting: Emergency departments in 23 UK hospitals.

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.

Effect of a 2-week interruption in methotrexate treatment versus continued treatment on COVID-19 booster vaccine immunity in adults with inflammatory conditions (VROOM study): a randomised, open label, superiority trial.

Background: Immunosuppressive treatments inhibit vaccine-induced immunity against SARS-CoV-2. We evaluated whether a 2-week interruption of methotrexate treatment immediately after the COVID-19 vaccine booster improved antibody responses against the S1 receptor-binding domain (S1-RBD) of the SARS-CoV-2 spike protein compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases.

Methods: We did an open-label, prospective, two-arm, parallel-group, multicentre, randomised, controlled, superiority trial in 26 hospitals in the UK.

Randomised controlled trial comparing intraoperative cell salvage and autotransfusion with standard care in the treatment of hip fractures: a protocol for the WHITE 9 study.

Introduction: People who sustain a hip fracture are typically elderly, frail and require urgent surgery. Hip fracture and the urgent surgery is associated with acute blood loss, compounding patients' pre-existing comorbidities including anaemia. Approximately 30% of patients require a donor blood transfusion in the perioperative period.