This paper describes how reference-based conditional mean imputation, with variance estimation justified solely by its frequentist performance, has the surprising and undesirable property that the estimated variance becomes smaller the greater the number of missing observations; as explained under jump-to-reference it effectively forces the true treatment effect to be exactly zero for patients with missing data.

This paper provides an overview of the estimands framework, as outlined in the addendum, with the aim of explaining why estimands are beneficial; clarifying the terminology being used; and providing practical guidance on using estimands to decide the appropriate study design, data collection, and estimation methods.

This article described how estimands help researchers to pinpoint their exact research question.

Using two large critical care trials (ADRENAL and NICE-SUGAR), this paper assesses the performance of three frequentist and two Bayesian adaptive trial design approaches.

For simulation studies that evaluate methods of handling missing data, the authors argue in this letter that generating partially observed data by fixing the complete data and repeatedly simulating the missingness indicators is a superficially attractive idea but only rarely appropriate to use.

This paper presents a co-developed a tool for researchers and public partners to use to facilitate the involvement of public partners in estimand discussions. And public partner views on being invovled in estimand discussions in a trial design context.

Using a tuberculosis clinical trial as a case study, this paper proposes a primary estimand, and an additional estimand suitable for non-inferiority studies.

The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. In this paper, authors demonstrate application of the estimand framework to clearly define the treatment effect estimate for the primary outcome.

In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist, and elaborate on each item relevant to complete reporting of harms in randomised controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomised controlled trials should use the integrated checklist presented in this paper.

Improving evaluation of harm outcomes in randomised trials goes beyond the Consort harms reporting guidelines, write Rachel Phillips and Victoria Cornelius in this BMJ Opinion piece