Early-stage randomised controlled trial of therapist-supported online cognitive therapy for post-traumatic stress disorder in young people.

Background: Effective face-to-face treatments for Post-Traumatic Stress Disorder (PTSD) are available, but most young people with PTSD do not receive effective treatment. Therapist-supported online Cognitive Therapy has the potential to improve accessibility of effective treatment. This early-stage trial gathered data on the feasibility, acceptability, and initial signal of clinical efficacy of a novel online Cognitive Therapy program for young people with PTSD.

Expanding Research on Contextual Factors in Autism Research: What Took Us So Long?

Although autism is a childhood-onset neurodevelopmental disorder, its features change across the life course due to a combination of individual and contextual influences. However, the influence of contextual factors on development during childhood and beyond is less frequently studied than individual factors such as genetic variants that increase autism risk, IQ, language, and autistic features. Potentially important contexts include the family environment and socioeconomic status, social networks, school, work, services, neighborhood characteristics, environmental events, and sociocultural factors.

Effects of Actissist, a digital health intervention for early psychosis: A randomized clinical trial.

Schizophrenia affects 24 million people worldwide. Digital health interventions drawing on psychological principles have been developed, but their effectiveness remains unclear. This parallel, assessor-blinded, randomized clinical trial aimed to investigate whether a cognitive behaviour therapy-informed digital health intervention (Actissist app) confers added benefit on psychotic symptoms over and above remote symptom monitoring (ClinTouch app).

How do autistic people fare in adult life and can we predict it from childhood?

This study describes social, mental health, and quality of life outcomes in early adulthood, and examines childhood predictors in the Special Needs and Autism Project (SNAP), a longitudinal population-based cohort. Young autistic adults face variable but often substantial challenges across many areas of life. Prediction of outcomes is important to set expectations and could lead to the development of targeted early intervention.

Therapist-supported online cognitive therapy for post-traumatic stress disorder (PTSD) in young people: protocol for an early-stage, parallel-group, randomised controlled study (OPTYC trial).

Introduction: Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition that affects a significant minority of young people exposed to traumatic events. Effective face-to-face psychological treatments for PTSD exist. However, most young people with PTSD do not receive evidence-based treatment.

Predicting Uncertain Multi-Dimensional Adulthood Outcomes From Childhood and Adolescent Data in People Referred to Autism Services.

Introduction: Autism spectrum disorder is a highly heterogeneous diagnosis. When a child is referred to autism services or receives a diagnosis of autism spectrum disorder it is not known what their potential adult outcomes could be. We consider the challenge of making predictions of an individual child's long-term multi-facetted adult outcome, focussing on which aspects are predictable and which are not.

Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?-a systematic review.

Background: Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to enhance understanding of RCT findings. However, issues pertaining to process evaluation in this specific context have been little discussed. We aimed to describe the frequency, characteristics, labelling, value, practical conduct issues, and accessibility of published process evaluations within pragmatic RCTs in health services research.

How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the Pre-SPEC framework.

Results from clinical trials can be susceptible to bias if investigators choose their analysis approach after seeing trial data, as this can allow them to perform multiple analyses and then choose the method that provides the most favourable result (commonly referred to as 'p-hacking'). Pre-specification of the planned analysis approach is essential to help reduce such bias, as it ensures analytical methods are chosen in advance of seeing the trial data. For this reason, guidelines such as SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and ICH-E9 (International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) require the statistical methods for a trial's primary outcome be pre-specified in the trial protocol.

Public availability and adherence to prespecified statistical analysis approaches was low in published randomized trials.

Background And Objective: Prespecification of statistical methods in clinical trial protocols and statistical analysis plans can help to deter bias from p-hacking but is only effective if the prespecified approach is made available.

Study Design And Setting: For 100 randomized trials published in 2018 and indexed in PubMed, we evaluated how often a prespecified statistical analysis approach for the trial's primary outcome was publicly available. For each trial with an available prespecified analysis, we compared this with the trial publication to identify whether there were unexplained discrepancies.

Evidence of unexplained discrepancies between planned and conducted statistical analyses: a review of randomised trials.

Background: Choosing or altering the planned statistical analysis approach after examination of trial data (often referred to as 'p-hacking') can bias the results of randomised trials. However, the extent of this issue in practice is currently unclear. We conducted a review of published randomised trials to evaluate how often a pre-specified analysis approach is publicly available, and how often the planned analysis is changed.

How pragmatic are the randomised trials used in recommendations for control of glycosylated haemoglobin levels in type 2 diabetic patients in general practice: an application of the PRECIS II tool.

Background: Recommendations for good clinical practice have been reported to be difficult to apply in real life by primary care clinicians. This could be because the clinical trials at the origin of the guidelines are based on explanatory trials, conducted under ideal conditions not reflecting the reality of primary care, rather than pragmatic trials conducted under real-life conditions. The objective of this study was to evaluate how pragmatic are the clinical trials used to build the French High Authority of Health's recommendations on the management of type II diabetes.

MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.

Objectives: To evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain.

Design: Three arm randomised feasibility trial.

Setting: Women were recruited at two gynaecology clinics in the UK.

Improving the relevance of randomised trials to primary care: a qualitative study investigating views towards pragmatic trials and the PRECIS-2 tool.

Background: Pragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice. PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary-2) is a trial design tool which considers how pragmatic a trial is across a number of domains. It is not known whether a pragmatic approach to all PRECIS-2 domains leads to results being more relevant to primary care.

Co-producing Randomized Controlled Trials: How Do We Work Together?

In the light of the declaration "Nothing about us without us" (Charlton, 2000), interest in co-production, and coproduced research is expanding. Good work has been done establishing principles for co-production (Hickey et al., 2018) and for good quality involvement (Involve, 2013; 4Pi, 2015) and describing how this works in practice in mental health research (Gillard et al.

Physiological, hyaluronan-selected intracytoplasmic sperm injection for infertility treatment (HABSelect): a parallel, two-group, randomised trial.

Background: Sperm selection strategies aimed at improving success rates of intracytoplasmic sperm injection (ICSI) include binding to hyaluronic acid (herein termed hyaluronan). Hyaluronan-selected sperm have reduced levels of DNA damage and aneuploidy. Use of hyaluronan-based sperm selection for ICSI (so-called physiological ICSI [PICSI]) is reported to reduce the proportion of pregnancies that end in miscarriage.

Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery.

Introduction: Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery.

Ethical implications of excessive cluster sizes in cluster randomised trials.

The cluster randomised trial (CRT) is commonly used in healthcare research. It is the gold-standard study design for evaluating healthcare policy interventions. A key characteristic of this design is that as more participants are included, in a fixed number of clusters, the increase in achievable power will level off.

Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial.

Background: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized.

Understanding the applicability of results from primary care trials: lessons learned from applying PRECIS-2.

Objective: To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion.

Study Design And Setting: We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the nine PRECIS-2 domains: first independently using an online version of PRECIS-2 and second following a discussion.

Increased risk of type I errors in cluster randomised trials with small or medium numbers of clusters: a review, reanalysis, and simulation study.

Background: Cluster randomised trials (CRTs) are commonly analysed using mixed-effects models or generalised estimating equations (GEEs). However, these analyses do not always perform well with the small number of clusters typical of most CRTs. They can lead to increased risk of a type I error (finding a statistically significant treatment effect when it does not exist) if appropriate corrections are not used.

The Impact of Preoperative Stoma Marking on Health-Related Quality of Life: A Comparison Cohort Study.

Purpose: The purpose of this study was to compare health-related quality of life (HRQOL) in patients receiving preoperative stoma marking by a certified wound, ostomy and continence nurse (CWOCN) to patients who did not receive preoperative marking.

Design: Quasi-experimental, nonrandomized comparison cohort study.

Subjects And Setting: The sample comprised 59 patients immediately following creation of a fecal stoma during an 18-month period between 2008 and 2010.

Evaluation of a Nurse-Driven Protocol to Remove Urinary Catheters: Nurses' Perceptions.

This article describes nurses' perceptions of the effect of a nurse-driven protocol in a Magnet-designated hospital. Post-protocol implementation data indicate improved job ease and positive patient feedback following protocol implementation. Younger or less-experienced nurses were likely to use the protocol.