The number needed to treat: It is time to bow out gracefully - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

There has been a lot of debate recently about the promise of real world data - the routine (observational) data collected on patients eg  treatments received, clinical outcomes etc – for estimating treatment effects. But can they deliver? 1/9 #MethodologyMonday #123

Improving the design of staggered implementation cluster randomised trials qualitysafety.bmj.com/content/earl...

We often now hear the term “Bayesian borrowing” in trials. But what is Bayesian borrowing and what are the pros and cons around its use? 1/6 #MethodologyMonday #122

NEW PAPER in @bmj.com "Dealing with continuous variables and modelling non-linear associations in healthcare data: practical guide" --> www.bmj.com/content/390/... #methodologymatters #StatsSky #EpiSky

What's that? The target trial emulation obtained the same answer as the RCT? Wow, I guess RCTs are generalisable after all! Perhaps we should perform them rather than using interventions on hundreds of thousands of people before we know whether or not they work, then doing a TTE?

Reckon I can submit this as a figure for a paper?

New post: “Marginal” and “conditional” are relative descriptions of an estimand

New paper posted on Arxiv: "When do composite estimands answer non-causal questions?" This can happen more often than you think, and can have a dramatic impact on trial results (e.g. a false-positive rate of almost 90%) arxiv.org/abs/2506.22610 @timpmorris.bsky.social

The CONSORT 2025 Statement is here. Essential reading for those involved in the reporting & reviewing of randomized trials. We're proud to see so many #UKCTUNetwork units & individual researchers contributing to this crucial update! 🔗 tinyurl.com/yc3cbh33 #CONSORT2025 #ResearchTransparency

Would like to add… there are guidelines for all types of studies… www.equator-network.org/reporting-gu...

Please people. It's not hard. In fact, it makes your life easier. And when you don't use CONSORT, you look like a novice.

Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent. Learn more in this Special Communication. https://ja.ma/3TlnKQe

Stepped wedge devotees step up, and cluster enthusiasts get ready to cluster: it's conference time again.

🆕New CONSORT & SPIRIT 2025 Guidelines Our colleagues helped shape these updates, making #ClinicalTrial reporting more transparent & useful for everyone. Key changes: ✔️More open science ✔️Better reporting of harms & missing data ✔️Greater harmonisation between guidelines More info: buff.ly/HC1rx31

NEW PAPER "Importance of sample size on the quality and utility of AI-based prediction models for healthcare" www.thelancet.com/journals/lan... We discuss seven reasons why inadequate sample size negatively affects model training, evaluation, and performance. #StatsSky #machinelearning #AI

One of the trial designs that has been cropping up in my discussions recently is the cluster randomised crossover, or CRXO, design. But when is it best used & what are the key issues to look out for? 1/7 #MethodologyMonday #119

New 3-post for a research/senior research fellow to work on adaptive longitudinal cluster randomised trials in Melbourne. Interesting work with a great research group. careers.pageuppeople.com/513/cw/en/jo...

Next Thursday, June 5th at 1pm (BST) we host our 4th webinar in our adverse event special series. Rayan Taher & Jenny Yiend will present their work on developing a process for assessing the safety of a digital mental health intervention & gaining regulatory approval. Register here: lnkd.in/eaW3MQrB

Hot off the press: bmcmedresmethodol.biomedcentral.com/articles/10.... In this we confirm empirically some theoretical results about using different summary measures in non-inferiority trials with survival outcomes. tldr: RMST beats HR.

Read the original paper here: trialsjournal.biomedcentral.com/articles/10....

Next week (May 22nd) we host our third webinar in our adverse event special series. Regina Stegherr will be discussing the SAVVY project which aims to improve the analyses of AEs in clinical trials using survival methods to handle varying follow-up & competing events. Register here: lnkd.in/eaW3MQrB

In 2023 Trials invited submissions that related to the collection, analysis & reporting of adverse events in clinical trials. In this editorial @vcornelius.bsky.social & I summarise the submissions & discuss the implications on applied clinical trials & future methodological research rdcu.be/elLFa

A Consensus Statement in Nature Medicine from CONSORT 2025 provides updated guidance to authors, reviewers and editors, when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent. go.nature.com/3Si0p1f #medsky 🧪

This week saw the publication of SPIRIT 2025, a major update to the international SPIRIT Statement which provides guidance on what should be included in a trial protocol. 1/6 #MethodologyMonday #117

The CONSORT and SPIRIT statements for randomized trials have been updated for 2025 and published in JAMA, with a new focus on open science principles and guidance on trial registration, data access, and conflict of interest reporting. ➡ CONSORT 2025: ja.ma/3Yyu0Hh ➡ SPIRIT 2025: ja.ma/3YjFfn8

Estimands are a way to clearly define the research question in #ClinicalTrials. This animated video explains how using estimands can help doctors and patients make informed treatment decisions.▶️👇 buff.ly/xiz3mU6 #StatsSky

I call (3) the ‘realisability criterion’. Ok, so people did/do not adhere. Why? Could you tell who would not adhere in a future population and only offer the intervention to them? Or could you make everyone adhere? Time for a shameless plug @brennankahan.bsky.social www.bmj.com/content/384/...

Why? For (1) & (2), it’s a sleight-of-hand to claim an estimation method is diluted/biased compared to the ‘true’ effect of treatment if you have not said what true effect you think people should be estimating. There is usually more than one reasonable estimand.

Oh good ‘ITT analyses are biased’ is back, here using the euphemism ‘diluted’ 🙃 The rules are that you have to: 1. say what your estimand is before saying an analysis is ‘diluted’/‘biased’ 2. admit that there are other reasonable estimands 3. describe how it could be realised in a future population

NEW PAPER: Updated SPIRIT-2025 for reporting protocols of randomised trials is now available in the @BMJ.com, @JAMA.com, @thelancet.bsky.social, @PLoS.org, and @natmedicine.bsky.social. —> www.bmj.com/content/389/... #openscience #transparency #medsky #statssky #episky

SPIRIT 2025 guidelines for protocols now published in @bmj.com journal and others www.bmj.com/content/389/...

HIRING! We offer 3 fully funded PhD positions to work on research methodology with experts in a great medical research environment. More info: www.linkedin.com/feed/update/...

Shouldn't need saying, but clearly it does "Reporting guideline checklists are not quality evaluation forms: they are guidance for writing" --> onlinelibrary.wiley.com/doi/10.1002/... ...quality/risk of bias assessment is aided by transparent reporting though.

A major update to the CONSORT reporting guidance for clinical trials was published last week. 📌 CONSORT 2025 replaces all previous versions and should be used from now on. So what’s new and what’s different? 1/7 #MethodologyMonday #116 (COI - I am a co-author)

Improving the completeness and transparency of protocols and reports of randomized trials: SPIRIT 2025 and CONSORT 2025 - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

In #ClinicalTrials, estimands are a way to describe the research question, helping stakeholders understand and interpret trial results. Watch this video to learn how using estimands can help doctors and patients make better treatment decisions.▶️👇 buff.ly/LbUEgca #StatsSky #MedSky

The CONSORT statement has been updated to reflect recent methodological advancements and user feedback. This article describes the rationale for each checklist item and provides published examples of good reporting www.bmj.com/content/389/...

Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. This update to the CONSORT guidelines includes new changes to the checklist www.bmj.com/content/389/...

Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent. Learn more in this Special Communication. https://ja.ma/3Yyu0Hh

NEW: CONSORT 2025 now published! Some notable changes: -items on analysis populations, missing data methods, and sensitivity analyses -reporting of non-adherence and concomitant care -reporting of changes to any study methods, not just outcomes -and lots of other things www.bmj.com/content/389/...

It’s a big day in the reporting guidelines and transparency calendar with the release of the new and revised CONSORT statement for reporting randomised trials (CONSORT-2025) You can get the reporting recommendations here www.bmj.com/content/389/... #OpenAccess #ResearchIntegrity #Transparency

NEW PAPER: Updated CONSORT-2025 for reporting randomised trials is now available in the @bmj.com @jama.com , @thelancet.bsky.social, @plos.org and @naturemedicine.bsky.social —> www.bmj.com/content/389/... #openscience #transparency #medsky #statssky #episky

Estimands define the research question in #ClinicalTrials to help stakeholders understand and interpret trial results and make better decisions about treatments. Our latest video explores the importance of estimands in the context of a mental health trial. Watch now ▶️👇 buff.ly/xiz3mU6 #StatsSky

Exploring the effect of COVID-19 restrictions on the social functioning scale in a clinical trial of antipsychotic reduction: using multiple imputation to target a hypothetical estimand is out in @jclinepi.bsky.social www.sciencedirect.com/science/arti... 1/n

New paper in @bmj.com. Ever been told ‘what does your DAG say?” or “show me your DAG”, or “ok draw a DAG” and not sure what that means or how to get started? Well buckle up, because Fernando Hartwig, @neilmdavies.bsky.social and I wrote an RMR on just this topic. www.bmj.com/content/388/...

New publication led by @proflouisemarston.bsky.social using multiple imputation to target a hypothetical estimand in a pandemic restriction-free world for a trial in schizophrenia - demonstrating the potential impact of the pandemic on the trial results

How avoidance of research waste is now emphasized in the Declaration of Helsinki, and how you might want to improve some of your data management and analysis practices in light of this change (talk, 40 minutes). www.youtube.com/watch?v=q1nb...

New post on dealing with missing baseline values in randomised trials that analyse change-from-baseline open.substack.com/pub/tpmorris...

Funders expect evidence of 'promise' (the intervention is likely to work) when considering whether to fund an RCT, pilot, or feasibility study. But there is no shared understanding of how we should do this. We have been funded by @nihr.bsky.social to develop guidance to help.