Results of a feasibility study of the FReSH START intervention to improve quality of life and other outcomes in people who repeatedly self-harm (Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy).

Background: Self-harm is a major public health challenge with estimated lifetime prevalence of 5-6% and 220,000 hospital attendances annually in England and Wales. Repetition of self-harm is common with 70% of hospital attenders reporting previous self-harm. Multiple repetition bears a significant cost to individuals and healthcare systems.

Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event.

Background: Digital technologies, such as wearable devices and smartphone applications (apps), can enable the decentralisation of clinical trials by measuring endpoints in people's chosen locations rather than in traditional clinical settings. Digital endpoints can allow high-frequency and sensitive measurements of health outcomes compared to visit-based endpoints which provide an episodic snapshot of a person's health. However, there are underexplored challenges in this emerging space that require interdisciplinary and cross-sector collaboration.

Effectiveness and cost-effectiveness of a sustainable obesity prevention programme for preschool children delivered at scale 'HENRY' (Health, Exercise, Nutrition for the Really Young): protocol for the HENRY III cluster randomised controlled trial.

Introduction: One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings aim to support families to navigate these in order to prevent obesity. One of these programmes (Health, Exercise and Nutrition for the Really Young, HENRY) has been delivered in UK community venues (hereon named 'centres') in high deprivation areas since 2008 and aims to help families to provide a healthy start for their preschool children.

Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.

Background: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community.

Methods: The PRIMORANT study had three phases.

Overprescribing of potentially harmful medication: an observational study in England's general practice.

Background: Overprescribing of potentially harmful medication in UK general practice has a complex association with socioeconomic deprivation.

Aim: To assess trends in general practice prescribing of five high-risk medications and their relationship with deprivation.

Design & Setting: An observational study was conducted using general practice data from three English regions with varied sociodemographic factors: West Yorkshire and Harrogate (WY), Black Country and West Birmingham (BC), and Surrey and East Sussex (SE).

A cluster randomised controlled trial, process and economic evaluation of quality improvement collaboratives aligned to a national audit to improve the care for people with diabetes (EQUIPD): study protocol.

Background: People with type 1 diabetes and raised glucose levels are at greater risk of retinopathy, nephropathy, neuropathy, cardiovascular disease, sexual health problems and foot disease. The UK National Institute for Health and Care Excellence (NICE) recommends continuous subcutaneous 'insulin pump' therapy for people with type 1 diabetes whose HbA1c is above 69 mmol/mol. Insulin pump use can improve quality of life, cut cardiovascular risk and increase treatment satisfaction.

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

Introduction: Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was developed.

A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study.

Background: To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.

Methods: We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.

Cancer patients' needs assessment in primary care: study protocol for a cluster randomised controlled trial (cRCT), economic evaluation and normalisation process theory evaluation of the needs assessment tool cancer (CANAssess).

Introduction: Unmet needs in patients with cancer and their carers are common but poorly identified and addressed. The Needs Assessment Tool-Cancer (NAT-C) is a structured consultation guide to identify and triage patient and carer unmet needs. The NAT-C is validated, but its effectiveness in reducing unmet patient and carer needs in primary care is unknown.

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis.

Background: We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs.

Methods And Findings: We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study.

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial.

Background: Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children's centre and local authority stakeholders.

Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children.

Background: Community-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the UK. Early evidence suggests that it may be effective, but a robust evaluation has not been conducted.

Cognitive-behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis.

Background: Cognitive-behavioural therapy aims to increase quality of life by changing cognitive and behavioural factors that maintain problematic symptoms. A previous overview of cognitive-behavioural therapy systematic reviews suggested that cognitive-behavioural therapy was effective for many conditions. However, few of the included reviews synthesised randomised controlled trials.

The evidence for cognitive behavioural therapy in any condition, population or context: a meta-review of systematic reviews and panoramic meta-analysis.

The majority of psychological treatment research is dedicated to investigating the effectiveness of cognitive behavioural therapy (CBT) across different conditions, population and contexts. We aimed to summarise the current systematic review evidence and evaluate the consistency of CBT's effect across different conditions. We included reviews of CBT randomised controlled trials in any: population, condition, format, context, with any type of comparator and published in English.

A review found inadequate reporting of case-control studies of risk factors for pancreatic cancer.

Objectives: Case-control studies are often used to identify the risk factors for pancreatic cancer. The objective of this study was to evaluate the reporting of case-control studies of the risk factors for pancreatic cancer using the Strengthening The Reporting of OBservational Studies in Epidemiology (STROBE) for case-control studies checklist.

Study Design And Setting: We conducted a comprehensive literature search of the MEDLINE and EMBASE databases to identify reports of case-control studies published between 2016 and 2018.

Evaluating the impact of a champion on implementation of the Back Skills Training (BeST) programme in Canada: a mixed methods feasibility study protocol.

Introduction: There is global recognition that low back pain (LBP) should be managed with a biopsychosocial approach. Previous implementation of this approach resulted in low uptake and highlighted the need for ongoing support. This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation.

Evaluation of the implementation of the Back Skills Training (BeST) programme using online training: a cohort implementation study.

Objectives: 1) Evaluate implementation of the Back Skills Training (BeST) programme, a group cognitive behavioural approach for patients with low back pain (LBP) developed for a clinical trial, into the National Health Service (NHS) in the United Kingdom; 2) Compare patient outcomes with the BeST Trial results.

Design: Two stage observational cohort implementation study.

Participants: Stage 1: NHS Clinicians enrolled in BeST online training.

Design, analysis and reporting of multi-arm trials and strategies to address multiple testing.

Background: It is unclear how multiple treatment comparisons are managed in the analysis of multi-arm trials, particularly related to reducing type I (false positive) and type II errors (false negative).

Methods: We conducted a cohort study of clinical-trial protocols that were approved by research ethics committees in the UK, Switzerland, Germany and Canada in 2012. We examined the use of multiple-testing procedures to control the overall type I error rate.

Family physician referral rates for lumbar spine computed tomography in Newfoundland and Labrador: a cross-sectional analysis using routinely collected data.

Background: Reducing computed tomography (CT) examinations of the lumbar spine is one of Choosing Wisely Canada's initial top 10 recommendations. This study's objective was to report the age- and-sex standardized rates of lumbar spine CT ordered by family physicians in 1 health region in Newfoundland and Labrador.

Methods: We conducted a retrospective study using local health data from Meditech, an electronic health record system, from 2013 to 2016 for the Eastern Health Region of Newfoundland and Labrador, the largest health region in the province.

What is usual care for low back pain? A systematic review of health care provided to patients with low back pain in family practice and emergency departments.

International clinical practice guidelines for low back pain (LBP) contain consistent recommendations including universal provision of information and advice to remain active, discouraging routine referral for imaging, and limited prescription of opioids. This systematic review describes usual care provided by first-contact physicians to patients with LBP. Studies that reported the assessments and care provided to people with LBP in family practice and emergency departments (EDs) from January 2000 to May 2019 were identified by searches of PubMed, EMBASE, and CINAHL.

Multifactorial interventions for preventing falls in older people living in the community: a systematic review and meta-analysis of 41 trials and almost 20 000 participants.

Objective: To assess the longer term effects of multifactorial interventions for preventing falls in older people living in the community, and to explore whether prespecific trial-level characteristics are associated with greater fall prevention effects.

Design: Systematic review with meta-analysis and meta-regression.

Data Sources: MEDLINE, EMBASE, CINHAL, CENTRAL and trial registries were searched up to 25 July 2018.

Duration of Treatment Effect Should Be Considered in the Design and Interpretation of Clinical Trials: Results of a Discrete Choice Experiment.

This study examined whether duration of treatment effect should be considered in a benefit-risk assessment using a case study of osteoarthritis medications. A discrete choice experiment was completed by 300 residents of the United Kingdom with hip and/or knee osteoarthritis. In 16 choice tasks, participants selected their preferred option from 2 medications.

Sample size calculations are poorly conducted and reported in many randomized trials of hip and knee osteoarthritis: results of a systematic review.

Objectives: To review the methodology and reporting of sample size calculations in a contemporary sample of trials in osteoarthritis.

Study Design And Setting: Randomized trials in hip and/or knee osteoarthritis published in 2016 were identified by searching MEDLINE, Cochrane library, CINAHL, EMBASE, PsycINFO, PEDro, and AMED until March 31, 2017. Data were extracted on study characteristics, methods used to calculate the sample size, and the reporting and justification of components used in the sample size calculation.