SCHARR Medical Statistics Group

Clinical advisors at NHS 111 improve accuracy for paediatric patients and their advice is more reliably followed: a retrospective observational cohort study Objective To determine whether National Health Service (NHS) 111 advice regarding paediatric patients given by clinically trained health advisors (CHAs) is, as previously found for adult patients, les...

Happily, we've had faster progress with another recent paper, just published! We use #CUREd data to show quite dramatic differences in how clinical & non-clinical NHS 111 staff handle calls about children: adc.bmj.com/content/earl... #NHS111 #BMJ #NHS @scharr-msg.bsky.social @arc-yharc.bsky.social

How is missing data handled in cluster randomized controlled trials? A review of trials published in the NIHR Journals Library 1997–2024

journals.sagepub.com/doi/10.1177/...

Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials - BMC Medicine Background Adaptive designs are increasingly being used in clinical trials within diverse clinical areas. They can offer advantages over traditional non-adaptive approaches, including improved efficiency and patient benefit. The level of improvement observed in practice depends to a large degree on conducting interim analyses (at which adaptations can be made to the trial based on collected data) rapidly and to a high standard. Methods The ROBust INterims for adaptive designs (ROBIN) project aimed to identify best practice for conducting high-quality and rapid interim analyses. This was done through evidence synthesis of published work, qualitative research with trial stakeholders working at public sector clinical trials units, engagement with patients and the public, and a meeting of trial stakeholders to discuss findings and agree recommendations. Results This paper provides recommendations for teams that conduct adaptive trials about how to ensure interim analyses are done rapidly and to a high standard. We break down recommendations by stage of the trial. We also identify a lack of methodology on how best to involve patients in adaptive trials and related decision-making. A limitation of our recommendations is that the research was mostly focused on UK academic settings, although we believe much of the recommendations are relevant in other countries and to industry-sponsored trials. Conclusions When following the recommendations outlined in this paper, the process of planning and executing interim analyses will be smoother; in turn, this will lead to more benefits from using adaptive designs.

Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials
bmcmedicine.biomedcentral.com/articles/10....

Confidence Intervals for Adaptive Trial Designs II: Case Study and Practical Guidance In adaptive clinical trials, the conventional confidence interval (CI) for a treatment effect is prone to undesirable properties such as undercoverage and potential inconsistency with the final hypot...

onlinelibrary.wiley.com/doi/10.1002/...

Confidence Intervals for Adaptive Trial Designs I: A Methodological Review Regulatory guidance notes the need for caution in the interpretation of confidence intervals (CIs) constructed during and after an adaptive clinical trial. Conventional CIs of the treatment effects a...

New publications on Confidence Intervals for Adaptive Trial Designs @mdimairo.bsky.social

onlinelibrary.wiley.com/doi/10.1002/...

Comparison of statistical methods for the analysis of patient-reported outcomes (PROs), particularly the Short-Form 36 (SF-36), in randomised controlled trials (RCTs) using standardised effect size (S... Background The Short-Form 36 (SF-36), a widely used patient-reported outcome (PRO), is a questionnaire completed by patients measuring health outcomes in clinical trials. The PRO scores can be discret...

Comparison of statistical methods for the analysis of patient-reported outcomes (PROs), particularly the Short-Form 36 (SF-36), in randomised controlled trials (RCTs) using standardised effect size (SES): an empirical analysis

hqlo.biomedcentral.com/articles/10....

Bookings are open for our online short course How to Understand Statistics in Research

Thursday 1st May - Thursday 22nd May 2025 (4 half-day sessions, over 4 consecutive weeks)

Course lead:
@richardjacques.bsky.social

For more information see:
www.sheffield.ac.uk/smph/modules...

The 'Reducing Avoidable Admissions in Acute Hospital Care: The role and impact of Same Day Emergency Care Services' project website is now live.

Find out about our research at: sites.google.com/sheffield.ac...

@sheffielduni.bsky.social @fohsheffield.bsky.social @arc-yharc.bsky.social

Further development of a patient-reported outcome measure to assess the impact of oral secretion problems in people living with MND Objective: Oral secretion problems are common yet poorly managed in people living with MND (plwMND). A validated patient-reported outcome for measuring saliva symptoms in this patient group would f...

Second paper from the prosec3 study: Further development of a patient-reported outcome measure to assess the impact of oral secretion problems in people living with MND www.tandfonline.com/doi/full/10....

Invitation to a Two-Round Delphi Study on Sample Size Reporting in Trial Grant Applications and Protocols for Adaptive Designs!

Click the link below to participate 👏:
docs.google.com/forms/d/e/1F...

Or directly contact: qzhang104@sheffield.ac.uk.

Please add me 🙂

Estimating the minimum important difference in the ALSFRS-R-instrument in people living with MND Objective: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) is a commonly used outcome measure in clinical trials for motor neuron disease (MND) therapies. As such, understandin...

New paper!! Estimating the minimum important difference in the ALSFRS-R-instrument in people living with MND www.tandfonline.com/doi/full/10....

How often are children attending the emergency department for a non-urgent attendance? - ARC In this study, we aimed to explore differences in non-urgent attendances and urgent attendances in children to ED and determine which children present in this way and when.

New Blog: How often are children attending the emergency department for a non-urgent attendance? Our statistician Rebecca Simpson breaks down the patterns in pediatric ED visits.

@sheffielduni.bsky.social

Read more: tinyurl.com/27spw598

In Nov I started my first NIHR funded research project as Chief Investigator.

Over the next 30 months, I'll be working with a fantastic team to investigate the impact of Same Day Emergency Care (SDEC) services on acute hospital admissions and discharge.

fundingawards.nihr.ac.uk/award/NIHR16...

Bookings are open for our online short course How to Understand Statistics in Research

Thursday 1st May - Thursday 22nd May 2025 (4 half-day sessions, over 4 consecutive weeks)

Course lead: @richardjacques.bsky.social

For more information see:
www.sheffield.ac.uk/smph/modules...

Non-urgent emergency department attendances in children: a retrospective observational analysis Introduction A significant proportion of ED attendances in children may be non-urgent attendances (NUAs), which could be better managed elsewhere. This study aimed to quantify NUAs and urgent attendan...

This is based on previously published work emj.bmj.com/content/39/1...

How often are children attending the emergency department for a non-urgent attendance? - ARC In this study, we aimed to explore differences in non-urgent attendances and urgent attendances in children to ED and determine which children present in this way and when.

New @arc-yharc.bsky.social blog by @beckiesimpson.bsky.social on "How often are children attending the emergency department for a non-urgent attendance?"

arc-yh.nihr.ac.uk/resources/bl...

Accuracy of the National Early Warning Score version 2 (NEWS2) in predicting need for time-critical treatment: retrospective observational cohort study Background Initial ED assessment can use early warning scores to identify and prioritise patients who need time-critical treatment. We aimed to determine the accuracy of the National Early Warning Sco...

Accuracy of the National Early Warning Score version 2 (NEWS2) in predicting need for time-critical treatment: retrospective observational cohort study

emj.bmj.com/content/earl...

A review of UK publicly funded non-inferiority trials: is the design more inferior than it should be? - Trials Background The number of non-inferiority (NI) trials, those aiming to show a new treatment is no worse than a comparator, is increasing. However, their added complexity over superiority trials can cre...

A review of UK publicly funded non-inferiority trials: is the design more inferior than it should be?

trialsjournal.biomedcentral.com/articles/10....

Confidence intervals for adaptive trial designs II: Case study and practical guidance In adaptive clinical trials, the conventional confidence interval (CI) for a treatment effect is prone to undesirable properties such as undercoverage and potential inconsistency with the final hypoth...

Our part 2 series paper in peer review...

Confidence intervals for adaptive trial designs II: Case study and practical guidance

arxiv.org/abs/2411.08771

Confidence intervals for adaptive trial designs I: A methodological review Regulatory guidance notes the need for caution in the interpretation of confidence intervals (CIs) constructed during and after an adaptive clinical trial. Conventional CIs of the treatment effects ar...

Our part 1 series paper in peer review ...

Confidence intervals for adaptive trial designs I: A methodological review

arxiv.org/abs/2411.08495

Cost-effectiveness of an extended-role general practitioner clinic for persistent physical symptoms: results from the Multiple Symptoms Study 3 (MSS3) pragmatic randomised controlled trial

www.valueinhealthjournal.com/article/S109...

Changes in depression symptoms over 10 years after TBI; a long-term prospective study Evaluate the prevalence and risk factors associated with depression symptoms at 10 years after traumatic brain injury (TBI) and compare with results at 10 weeks and 1 year.A large cohort of prospec...

Changes in depression symptoms over 10 years after TBI; a long-term prospective study: Brain Injury

www.tandfonline.com/doi/full/10....

The cost-effectiveness of using waking salivary cortisol in the diagnosis of adrenal sufficiency

eprints.whiterose.ac.uk/219103/

Impact of a national guideline for the management of peripheral arterial disease on revascularization rates in England: interrupted time series analysis A national guideline for managing peripheral arterial disease was released for the English National Health Service in August 2012. The impact on revascular

New Publication:

Impact of a national guideline for the management of peripheral arterial disease on revascularization rates in England: interrupted time series analysis | BJS Open | Oxford Academic

academic.oup.com/bjsopen/arti...

New paper published in Statistical Methods in Medical Research:

Comparison of statistical methods for the analysis of patient-reported outcomes in randomised controlled trials: A simulation study

journals.sagepub.com/doi/10.1177/...

Reporting and communication of sample size calculations in adaptive clinical trials: a review of trial protocols and grant applications - BMC Medical Research Methodology Background An adaptive design allows modifying the design based on accumulated data while maintaining trial validity and integrity. The final sample size may be unknown when designing an adaptive tria...

New Publication:

Reporting and communication of sample size calculations in adaptive clinical trials: a review of trial protocols and grant applications

bmcmedresmethodol.biomedcentral.com/articles/10....