David Torgerson

The University of York · Department of Health Sciences

Rationale Loss to follow‐up of participants can compromise the statistical validity of randomised trials. Moreover, it can have financial consequences for trial teams and funders. This study explores the Occupational Therapist Intervention Study (OTIS) where, despite a withdrawal rate of less than 10%, the trial team incurred opportunity costs rela...

Background Treatments for Dupuytren’s contracture include limited fasciectomy and collagenase injection. Evidence comparing these treatments is limited. Methods We performed an unblinded, multicenter, pragmatic, two-arm, randomized controlled non-inferiority trial comparing collagenase injection to limited fasciectomy in persons with moderate Dupu...

Background The presence of dental caries impacts on children’s daily lives, particularly among those living in deprived areas. There are successful interventions across the United Kingdom for young children based on toothbrushing with fluoride toothpaste. However, evidence is lacking for oral health improvement programmes in secondary-school pupils...

Background Young adults represent a third of the United Kingdom prison population and are at risk of poor health outcomes, including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce the negative consequences of criminal sanctions and address the root causes of offending. However, evidence of their effectiv...

Background People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple lo...

Background: Treatments for osteoarthritis (OA) are limited. Previous small studies suggest that the antirheumatic drug methotrexate may be a potential treatment for OA pain. Objective: To assess symptomatic benefits of methotrexate in knee OA (KOA). Design: A multicenter, randomized, double-blind, placebo-controlled trial done between 13 June...

Aims To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS). Methods A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized c...

Background Acute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current pra...

Background A number of children experience difficulties with social communication and this has long-term deleterious effects on their mental health, social development and education. The E-PLAYS-2 study will test an intervention (‘E-PLAYS’) aimed at supporting such children. E-PLAYS uses a dyadic computer game to develop collaborative and communica...

Introduction Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke...

Background Young adults who commit low-level offences commonly have a range of health and social needs and are significantly over-represented in the criminal justice system. These young adults may need to attend court and potentially receive penalties including imprisonment. Alternative routes exist, which can help address the underlying causes of...

Background The extra benefit of a programme of physiotherapy in addition to advice alone, following first-time traumatic shoulder dislocation, is uncertain. We compared the clinical and cost-effectiveness of a single session of advice with a single session of advice and a programme of physiotherapy. Objective The primary objective was to quantify...

Background and Aims Poor retention of trial participants is common and can result in significant methodological, statistical, ethical, and financial challenges. To improve trial efficiency, we aimed to assess the extent to which commonly used strategies to retain participants within trials are supported by evidence for their effectiveness. Method...

Objective To assess whether case finding for depression among people aged 65 and above improves mental health. Design Opportunistic evaluation using a regression discontinuity analysis with data from a randomised controlled trial. Setting The REFORM trial, a falls prevention study that recruited patients from NHS podiatry clinics. Participants 1...

Background Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential...

Background Lateral compression type-1 pelvic fractures are a common fragility fracture in older adults. Patients who do not mobilise due to ongoing pain are at greater risk of immobility-related complications. Standard treatment in the United Kingdom is provision of pain relief and early mobilisation, unlike fragility hip fractures, which are usual...

Background The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is...

The relationship between self-reported falls and fracture risk was estimated in an international meta-analysis of individual-level data from 46 prospective cohorts. Previous falls were associated with an increased fracture risk in women and men and should be considered as an additional risk factor in the FRAX® algorithm. Previous falls are a well-d...

Objective: To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. Design: Pragmatic, multicentre, randomised controlled trial (ARTISAN). Setting and participants: Trauma...

Objectives This multicentre, assessor‐blinded, two‐arm cluster randomized trial evaluated the clinical and cost‐effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in UK secondary schools. Methods Pupils aged 11–13 years with their own mobile telephone attending secondary schools with above average...

Background Randomised controlled trials (‘trials’) are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives PROMoting THE Use of Studies Within A T...

Background This paper describes the sociodemographics and oral health of UK secondary school pupils. They were participants of the BRIGHT trial, which was designed to evaluate the effectiveness of a toothbrushing intervention to reduce dental caries. Methods Overall, 4,680 pupils aged 11-13 years attending 42 secondary schools in England, Scotland...

Background Suboptimal or slow recruitment affects 30–50% of trials. Education and training of trial recruiters has been identified as one strategy for potentially boosting recruitment to randomised controlled trials (hereafter referred to as trials). The Training tRial recruiters, An educational INtervention (TRAIN) project was established to devel...

Background People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our...

Background People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple lo...

Background Medically unexplained symptoms (MUS) are difficult to diagnose due to their unknown aetiology, symptom overlap, and lack of effective treatments. MUS patients’ and general practitioners (GP) frequently face challenges during consultations: GPs report difficulty identifying and classifying MUS and patients report feeling illegitimised by...

Unlabelled: A large international meta-analysis using primary data from 64 cohorts has quantified the increased risk of fracture associated with a previous history of fracture for future use in FRAX. Introduction: The aim of this study was to quantify the fracture risk associated with a prior fracture on an international basis and to explore the...

Introduction Older adults with multimorbidity can experience poor health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. The British Wheel of Yoga’s Gentle Years Yoga© (GYY) programme was developed for older adults with chronic conditions. We investigated the effectiveness and cost-effectiveness of the GYY programme in old...

Evaluation report

Background Venous leg ulcer(s) are common, recurring, open wounds on the lower leg, resulting from diseased or damaged leg veins impairing blood flow. Wound healing is the primary treatment aim for venous leg ulceration, alongside the management of pain, wound exudate and infection. Full (high) compression therapy delivering 40 mmHg of pressure at...

Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded ‘study within a trial’ aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to thi...

Background Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with hemiarthroplasty (HA) and reverse shoulder arthroplasty (RSA) have been increasingly used for displaced 3- an...

Background This paper describes the socio-demographics and oral health of secondary school pupils. They were participants of the BRIGHT trial, which was designed to evaluate the effectiveness of a toothbrushing intervention to reduce dental caries. Methods Overall, 4680 pupils aged 11-13 years attending 42 secondary schools in England, Scotland, an...

Background Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age specific incidence is increasing. Surgical treatment with Hemiarthroplasty (HA) and Reverse Shoulder Arthroplasty (RSA) have been increasingly used for displaced 3- an...

Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Eva...

Background: Lateral compression type1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term imm...

Background Dental caries is common in young people and has wide-ranging ramifications for health and quality of life. Text messaging interventions show promise as a means to promote oral health behaviour change among young people. This paper reports the internal pilot of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial, which is evaluating a...

Background and Aims During the COVID‐19 pandemic, US Food and Drug Administration (FDA) permitted emergency use authorizations (EUAs) for vaccines/treatments with promising data. Eight treatments were issued EUAs by May 31, 2021; one of these was approved (Remdesivir for certain populations) and two were revoked (chloroquine phosphate/hydroxychloro...

Background Globally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural...

Background: Lateral compression type-1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. Current standard of care is non-surgical management, however patients with this injury are at risk of long term immobili...

Aim PROMoting THE USE of Studies Within A Trial (PROMETHEUS) aimed to improve the evidence base for recruiting and retaining participants in Randomised Controlled Trials (RCTs) by pump-priming and facilitating the start of at least 25 Studies Within A Trial (SWATs) testing recruitment or retention interventions. Methods Ten Clinical Trials Units (...

Aim To review the cost-effectiveness of strategies to improve participant recruitment and retention in randomised controlled trials. Methods All included studies from the latest Cochrane recruitment and retention reviews were considered. To identify articles published since the Cochrane reviews, electronic databases were searched until March 2021....

Aims Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohume...

Background Medically unexplained symptoms (MUS) account for 3–50% of all General Practitioner (GP) consultations and are difficult to diagnose due to their unknown aetiology, symptom overlap between conditions, and lack of effective treatment options. MUS patients’ and primary care clinicians frequently face challenges during consultations, with GP...

Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded ‘study within a trial’ aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to thi...

Objective: To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services. Design: Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phas...

Objective: To examine effectiveness, cost-effectiveness, generalizability and acceptability of financial incentives for smoking cessation during pregnancy ‘bolted-on’ to variously organised UK SSSs. This paper reports effectiveness. Design: A prospective pragmatic, multi-centre, parallel group, single-blinded, individually randomised controlled sup...

Aim Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical challenges. We aimed to identify these challenges and discuss possible solutions leading to b...

Objective To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection. Study design and setting Twelve surgical RCTs were eligib...

Introduction The PROMETHEUS programme (PROMoting THE USE of SWATs) was funded by the UK Medical Research Council (MRC) and Clinical Trials Unit (CTU) infrastructure funding from the National Institute for Health Research (NIHR). The purpose was to develop strategies to increase the recruitment and retention evidence base. This paper aims to present...

We describe the collection of cohorts together with the analysis plan for an update of the fracture risk prediction tool FRAX with respect to current and novel risk factors. The resource comprises 2,138,428 participants with a follow-up of approximately 20 million person-years and 116,117 documented incident major osteoporotic fractures. Introduct...

Background The BioDriveAFS trial aims to investigate whether a biomarker-based antifungal stewardship strategy is superior to a prophylactic antifungal strategy, including existing standard of care, in reducing antifungal therapy use in patients with acute leukaemia, without impacting health-related quality of life at 12 months. The trial will be c...

Background Effective and efficient conduct of randomised controlled trials (RCTs) ensures accurate, timely results and prevents research waste. There is however limited evidence available to inform the design, conduct and reporting of RCTs. A self-contained, randomised Study Within A Trial (SWAT), embedded within a host RCT or cohort study, offers...

Objectives To explore any age-related trend in workplace slip rate and assess the effectiveness of appropriate slip-resistant footwear in preventing workplace slips by age. Methods Secondary data analysis of the Stopping Slips among Healthcare Workers trial, a two-arm randomised controlled trial conducted between March 2017 and May 2019. 4553 Nati...

Background The aim of this trial was to assess the effectiveness of quality improvement collaboratives to implement large-scale change in the National Health Service (NHS) in the UK, specifically for improving outcomes in patients undergoing primary, elective total hip or knee replacement. Methods We undertook a two-arm, cluster randomised control...

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: 2x2 factorial ‘study within a trial’ of including a pen and/or £5 (GBP) in cash with a postal recruitment pack to increase the number of participants randomised into the host trial (‘Gentle Years Yoga’) for older adults with multimorbidity....

Introduction The PROMETHEUS programme (PROMoting THE USE of SWATs) was funded by the UK Medical Research Council (MRC) and Clinical Trials Unit (CTU) infrastructure funding from the National Institute for Health Research (NIHR). The purpose was to develop strategies to increase the recruitment and retention evidence base. This paper aims to present...

Objectives Dental caries is the most common preventable childhood condition. Non-dental professionals and health workers are often well placed to support parents in adopting positive oral health behaviours for their children. The aim of this study was to determine the effectiveness of behaviour change interventions and their individual component be...

Background Randomised controlled trials (RCTs) often struggle with various aspects of participant recruitment, including engaging clinicians to recruit effectively, and subsequently fail to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. The...

Background Young adult offenders represent a third of the UK prison population and are at risk of poor health outcomes including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce the negative consequences of formal criminal justice sanctions and focus resources on addressing the root causes of offending. Al...

Objectives To determine the effectiveness of sending Christmas cards to participants in randomised controlled trials to increase retention rate at follow-ups, and to explore the feasibility of doing a study within a trial (SWAT) across multiple host trials simultaneously. Design Randomised SWAT conducted simultaneously across eight host trials. S...

Objective This review investigates whether the distribution of recruitment to multicentre randomised controlled trials (RCTs) fits the “Pareto Principle”, i.e. 80% of participants are recruited by 20% of sites, or Price's Law, i.e. 50% of participants are recruited by the square root of the total number of sites. Methods A review of HTA reports pu...

Background: Postal questionnaires are frequently used in randomised controlled trials to collect outcome data on participants; however, poor response can introduce bias, affect generalisability and validity, and reduce statistical power. The objective of this study was to assess whether a pen and/or social incentive text cover letter sent with a po...

Background There is informal consensus that simple compression fractures of the body of the thoracolumbar vertebrae between the 10th thoracic vertebra and the second lumbar vertebra without neurological complications can be managed conservatively and that obvious unstable fractures require surgical fixation. However, there is a zone of uncertainty...

Background The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents...

Background Dupuytren’s contracture is a fibro-proliferative disease of the hands affecting over 2 million UK adults, particularly the white, male population. Surgery is the traditional treatment; however, recent studies have indicated that an alternative to surgery—collagenase clostridium histolyticum (collagenase)—is better than a placebo in the t...

Background: This study compares the 5-level version of the EQ-5D (5L) with the 3-level version EQ-5D (3L) in older adults using individual patient data from the REFORM (REducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. Methods: EQ-5D-5L and EQ-5D-3L were administered to men and women (n=151) over the age of 65 years alon...

Background The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better par...

Background: Several studies have investigated whether personalising trial documentation can aid recruitment and retention. We did a ‘study within a trial’ (SWAT) evaluating the effectiveness of a personalised text message compared to a non-personalised text message, on the retention rate in a large orthopaedic trial. Methods: The SWAT was embedded...

Background: We did a ‘study within a trial’ (SWAT), evaluating the effectiveness of the inclusion of a pen with a postal questionnaire, compared to no pen being included, on the retention rate in a large orthopaedic trial. Methods: The SWAT was embedded in the KReBS trial. The primary outcome was the proportion of 12-month questionnaires returned....

Objective Blocking is associated with prediction of the allocation sequence and subversion. This paper explores if blocking strategies lead to an increase in baseline age heterogeneity (a marker for potential subversion) and, whether the use of blocking is changing over time. Study Design and settings The British Medical Journal, Journal of the Am...