Sandra Eldridge
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View article: Evaluating re-identification risks scores in publicly available clinical trial datasets: Insights and implications
Evaluating re-identification risks scores in publicly available clinical trial datasets: Insights and implications Open
Background The 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 …
View article: 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
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 Open
Identifying 24 gaps reveals a need to update the Ottawa Statement. Alongside additional gaps identified in ongoing empirical work and through engagement with our patient and public partners, the gaps identified through this citation analys…
View article: Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration
Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration Open
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 d…
View article: Randomization Procedures in Parallel-Arm Cluster Randomized Trials in Low- and Middle-Income Countries: A Review of 300 Trials Published between 2017-2022
Randomization Procedures in Parallel-Arm Cluster Randomized Trials in Low- and Middle-Income Countries: A Review of 300 Trials Published between 2017-2022 Open
View article: Hadwiger Models: Low-Temperature Behavior in a Natural Extension of the Ising Model
Hadwiger Models: Low-Temperature Behavior in a Natural Extension of the Ising Model Open
All isometrically invariant Markov (strictly local) fields on binary assignments are induced by energy functions that can be represented as linear combinations of area, perimeter, and Euler characteristic. This class of model includes the …
View article: Co-designed and co-delivered place-based community interventions to reduce inequity in early initiation of antenatal care: Findings from the cluster randomised controlled Community REACH trial
Co-designed and co-delivered place-based community interventions to reduce inequity in early initiation of antenatal care: Findings from the cluster randomised controlled Community REACH trial Open
Background: Early initiation of antenatal care provides timely screening, advice and support. Inequities in early care initiation exist in high income countries, but there is scant evidence on effective interventions. The Community REACH t…
View article: A website for cluster randomised trials including stepped wedge: facilitating quality trials and methodological research
A website for cluster randomised trials including stepped wedge: facilitating quality trials and methodological research Open
We aim to keep the site updated with the latest publications and events related to cluster randomised trials, and welcome suggestions from the research community on further resources or events to add. We hope that the site will facilitate …
View article: “It’s just part of who I am…” Living with chronic headache: voices from the CHESS trial, a qualitative study
“It’s just part of who I am…” Living with chronic headache: voices from the CHESS trial, a qualitative study Open
View article: 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
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 Open
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 d…
View article: Development of a conceptual framework for defining trial efficiency
Development of a conceptual framework for defining trial efficiency Open
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 …
View article: Does pain self-efficacy predict, moderate or mediate outcomes in people with chronic headache; an exploratory analysis of the CHESS trial
Does pain self-efficacy predict, moderate or mediate outcomes in people with chronic headache; an exploratory analysis of the CHESS trial Open
View article: Reporting of cluster randomised crossover trials 2023: extension of the CONSORT 2010 statement with explanation and elaboration
Reporting of cluster randomised crossover trials 2023: extension of the CONSORT 2010 statement with explanation and elaboration Open
In this report we present the Consolidated Standards of Reporting Trials (CONSORT) extension for the cluster randomised crossover (CRXO) trial. A CRXO trial involves randomisation of groups of individuals (‘clusters’) to different sequence…
View article: Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs) Open
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 repl…
View article: Randomised trials conducted using cohorts: a scoping review
Randomised trials conducted using cohorts: a scoping review Open
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 participa…
View article: Why and when should we cluster randomize?
Why and when should we cluster randomize? Open
View article: Practical considerations for sample size calculation for cluster randomized trials
Practical considerations for sample size calculation for cluster randomized trials Open
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 cl…
View article: Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme
Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme Open
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 reten…
View article: Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs)
Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs) Open
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 structu…
View article: Investigating the impact of London’s ultra low emission zone on children’s health: children’s health in London and Luton (CHILL) protocol for a prospective parallel cohort study
Investigating the impact of London’s ultra low emission zone on children’s health: children’s health in London and Luton (CHILL) protocol for a prospective parallel cohort study Open
Background Air pollution harms health across the life course. Children are at particular risk of adverse effects during development, which may impact on health in later life. Interventions that improve air quality are urgently needed both …
View article: Use of routine healthcare data in randomised implementation trials: a methodological mixed-methods systematic review
Use of routine healthcare data in randomised implementation trials: a methodological mixed-methods systematic review Open
View article: Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial
Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial Open
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 …
View article: Non-pharmacological educational and self-management interventions for people with chronic headache: the CHESS research programme including a RCT
Non-pharmacological educational and self-management interventions for people with chronic headache: the CHESS research programme including a RCT Open
Background Headaches are a leading cause of years lived with disability. For some people, headaches become chronic and disabling, with treatment options being primarily pharmaceutical. Non-pharmacological alternative treatment approaches a…
View article: Device-Measured Change in Physical Activity in Primary School Children During the UK COVID-19 Pandemic Lockdown: A Longitudinal Study
Device-Measured Change in Physical Activity in Primary School Children During the UK COVID-19 Pandemic Lockdown: A Longitudinal Study Open
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 ac…
View article: Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting
Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting Open
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,…
View article: Group antenatal care: findings from a pilot randomised controlled trial of REACH Pregnancy Circles
Group antenatal care: findings from a pilot randomised controlled trial of REACH Pregnancy Circles Open
View article: Pilot and feasibility studies: extending the conceptual framework
Pilot and feasibility studies: extending the conceptual framework Open
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 be…
View article: Chronic Headache Education and Self-Management Study (CHESS): a process evaluation
Chronic Headache Education and Self-Management Study (CHESS): a process evaluation Open
Background The Chronic Headache Education and Self-Management Study (CHESS) multicentre randomised trial evaluated the impact a group education and self-management support intervention with a best usual care plus relaxation control for peo…
View article: PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely
PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely Open
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 Stud…
View article: Supportive Self-Management Program for People With Chronic Headaches and Migraine
Supportive Self-Management Program for People With Chronic Headaches and Migraine Open
This study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life in people with chronic migraine.
View article: Heterogeneity in pragmatic randomised trials: sources and management
Heterogeneity in pragmatic randomised trials: sources and management Open