Evaluating re-identification risks scores in publicly available clinical trial datasets: Insights and implications.

BackgroundThe motivations to share anonymised datasets from clinical trials within the scientific community are increasing. Many anonymised datasets are now publicly available for secondary research. However, it is uncertain whether they pose a privacy risk to the involved participants.

Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines.

Background: Although commonly used to evaluate health interventions, cluster randomized trials raise difficult ethical issues. Recognizing this, the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues across seven domains. But due to several developments in the design and implementation of cluster randomized trials, there are new issues requiring guidance.

Randomization procedures in parallel-arm cluster randomized trials in low- and middle-income countries: a review of 300 trials published between 2017-2022.

Objectives: Cluster randomized trials (CRTs) are frequently used to evaluate interventions in low- and middle-income countries (LMICs). Robust execution and transparent reporting of randomization procedures are essential for successful implementation and accurate interpretation of CRTs. Our objectives were to review the quality of reporting and implementation of randomization procedures in a sample of parallel-arm CRTs conducted in LMICs.

A survey on UK researchers' views regarding their experiences with the de-identification, anonymisation, release methods and re-identification risk estimation for clinical trial datasets.

Background: There are increasing pressures for anonymised datasets from clinical trials to be shared across the scientific community. However, there is no standardised set of recommendations on how to anonymise and prepare clinical trial datasets for sharing, while an ever-increasing number of anonymised datasets are becoming available for secondary research. Our aim was to explore the current views and experiences of researchers in the United Kingdom about de-identification, anonymisation, release methods and re-identification risk estimation for clinical trial datasets.

Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration.

This article presents the CONSORT (consolidated standards of reporting trials) extension for cluster randomised crossover trials. A cluster randomised crossover trial involves randomisation of groups of individuals (known as clusters) to different sequences of interventions over time. The design has gained popularity in settings where cluster randomisation is required because it can largely overcome the loss in power due to clustering in parallel cluster trials.

A website for cluster randomised trials including stepped wedge: facilitating quality trials and methodological research.

Background: A cluster randomised trial is a randomised controlled trial in which groups of individuals (clusters) are randomised to treatment arms. Stepped wedge cluster randomised trials are a type of cluster randomised trial where clusters are randomised to sequences. These trial designs are important for impacting decision-making, and it is therefore important that they be well-conducted and reported.

Development of a conceptual framework for defining trial efficiency.

Background: Globally, there is a growing focus on efficient trials, yet numerous interpretations have emerged, suggesting a significant heterogeneity in understanding "efficiency" within the trial context. Therefore in this study, we aimed to dissect the multifaceted nature of trial efficiency by establishing a comprehensive conceptual framework for its definition.

Objectives: To collate diverse perspectives regarding trial efficiency and to achieve consensus on a conceptual framework for defining trial efficiency.

Practical considerations for sample size calculation for cluster randomized trials.

Cluster randomized trials are an essential design in public health and medical research, when individual randomization is infeasible or undesirable for scientific or logistical reasons. However, the correlation among observations within clusters leads to a decrease in statistical power compared to an individually randomised trial with the same total sample size. This correlation - often quantified using the intra-cluster correlation coefficient - must be accounted for in the sample size calculation to ensure that the trial is adequately powered.

Why and when should we cluster randomize?

A cluster randomized trial is defined as a randomized trial in which intact social units of individuals are randomized rather than individuals themselves. Outcomes are observed on individual participants within clusters (such as patients). Such a design allows assessing interventions targeting cluster-level participants (such as physicians), individual participants or both.

Randomised trials conducted using cohorts: a scoping review.

Introduction: Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.

Objective: To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.

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.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

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.

Use of routine healthcare data in randomised implementation trials: a methodological mixed-methods systematic review.

Background: Routine data are increasingly used in randomised controlled trials evaluating healthcare interventions. They can aid participant identification, outcome assessment, and intervention delivery. Randomised implementation trials evaluate the effect of implementation strategies on implementation outcomes.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial.

Aim: The aim was to determine whether specialist-led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist-led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio-physiological investigations (INVEST).

Method: This was a parallel three-arm randomized single-blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST- versus no-INVEST-guided intervention.

Device-Measured Change in Physical Activity in Primary School Children During the UK COVID-19 Pandemic Lockdown: A Longitudinal Study.

Background: Lockdown measures, including school closures, due to the COVID-19 pandemic have caused widespread disruption to children's lives. The aim of this study was to explore the impact of a national lockdown on children's physical activity using seasonally matched accelerometry data.

Methods: Using a pre/post observational design, 179 children aged 8 to 11 years provided physical activity data measured using hip-worn triaxial accelerometers worn for 5 consecutive days prepandemic and during the January to March 2021 lockdown.

Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting.

Background: External randomised pilot trials aim to assess whether a future definitive Randomised Controlled Trial (RCT) is feasible. Prespecified progression criteria help guide the interpretation of pilot trial findings to decide whether, and how, a definitive RCT should be conducted. This commentary presents a set of proposed recommendations for progression criteria to guide researchers when (i) designing, (ii) conducting, (iii) analysing and (iv) reporting external randomised pilot trials.

Group antenatal care: findings from a pilot randomised controlled trial of REACH Pregnancy Circles.

Background: Antenatal care has the potential to impact positively on maternal and child outcomes, but traditional models of care in the UK have been shown to have limitations and particularly for those from deprived populations. Group antenatal care is an alternative model to traditional individual care. It combines conventional aspects of antenatal assessment with group discussion and support.

Pilot and feasibility studies: extending the conceptual framework.

In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies.

Supportive Self-Management Program for People With Chronic Headaches and Migraine: A Randomized Controlled Trial and Economic Evaluation.

Background And Objectives: Chronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce the burden of headache disability. We tested the effectiveness of a group educational and supportive self-management program for people living with chronic headaches.

Heterogeneity in pragmatic randomised trials: sources and management.

Background: Pragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions. Heterogeneity in patient characteristics contributes to heterogeneity in their response to the intervention. However, there are many other sources of heterogeneity in outcomes.

An analysis of published trials found that current use of pragmatic trial labels is uninformative.

Objectives: Randomized trials labelled as "pragmatic" are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g.

Systematic review of the characteristics of school-based feasibility cluster randomised trials of interventions for improving the health of pupils in the UK.

Background: The last 20 years have seen a marked increase in the use of cluster randomised trials (CRTs) in schools to evaluate interventions for improving pupil health outcomes. Schools have limited resources and participating in full-scale trials can be challenging and costly, given their main purpose is education. Feasibility studies can be used to identify challenges with implementing interventions and delivering trials.

STOP- a training intervention to optimise treatment for smoking cessation in community pharmacies: cluster randomised controlled trial.

Background: Community pharmacies serve people with high levels of tobacco-related illness, but throughput in NHS Stop Smoking Services in pharmacies remains relatively low. We investigated the effectiveness of a complex intervention to increase service uptake and retention.

Methods: We randomised 60 pharmacies in England and Wales to the STOP intervention or usual practice in a pragmatic, parallel-group, controlled trial over 11 months.