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Estimands in published protocols of randomised trials: urgent improvement needed

Kahan BC, Morris TP, White IT, Carpenter J, Cro S

This paper described a review of trial protocols published in October 2020 in Trials and BMJ Open. For each protocol is was investigated whether the estimand for the primary outcome was explicitly stated, not stated but inferable (i.e. could be constructed from the information given), or not inferable.

Trials Journal

Publication Date:

Oct 8, 2021

Commentary: Time to improve the reporting of harms in randomized controlled trials

Junqueira DR, Phillips R, Zorzela L, Golder S, Loke Y, Moher D, Ioannidis JPA, Vohra S

This article describes an overview of reviews to analyse changes in the reporting of harms in RCTs, in relation to the milestone of the publication of the CONSORT Harms guidance in 2004. Results showed that, overall, there has been only a slight improvement in the reporting of harms in clinical trials post publication of CONSORT Harms, and the reporting of harms in RCTs re- mains suboptimal as most trials report less than half of the CONSORT Harms items. We call for an update of CONSORT Harms to better align the reporting of harm outcomes with those of efficacy outcomes.

Publication Date:

Jul 31, 2021

Improving analysis practice of continuous adverse event outcomes in randomised controlled trials – a distributional approach

Chis Ster A, Phillips R, Sauzet O, Cornelius V

This article describes the challenges of dichotomised continuous safety outcomes in RCTs and explores a pragmatic approach to use a distributional approach for the analysis of binary outcomes that can retain power during the analysis


Publication Date:

Jun 28, 2021

A review of the use of controlled multiple imputation in randomised controlled trials with missing outcome data

Ping-Tee Tan, Suzie Cro, Eleanor Van Vogt, Matyas Szigeti, Victoria R Cornelius

Controlled Multiple Imputation (MI) procedures, including delta-based and reference-based approaches, have been developed for analysis under missing-not-at-random assumptions. This review evaluates the current use and reporting of MI and controlled MI in RCTs.

BMC Medical Research Methodology

Publication Date:

Apr 14, 2021

Skincare interventions in infants for preventing eczema and food allergy: A cochrane systematic review and individual participant data meta-analysis.

Kelleher MM, Cro S, Van Vogt E, Cornelius VR, et al.

A systematic review and Individual Participant Data (IPD) meta-analysis of skin care intervention trials for the prevention of eczema.

Clinical and Experimental Allergy

Publication Date:

Feb 6, 2021

Skin care interventions in infants for preventing eczema and food allergy

Kelleher MM, Cro S, Cornelius V, Van Vogt E, et al.

A Cochrane review including Individual Participant Data (IPD) meta-analysis of skin care intervention trials for the prevention of eczema

Cochrane Database of Systematic Reviews

Publication Date:

Feb 5, 2021

Advantages of visualisations to evaluate and communicate adverse event information in randomised controlled trials

Victoria Cornelius, Suzie Cro, Rachel Phillips

This article demonstrates the use of two plots to better support investigators to assimilate large volumes of adverse events data in randomised controlled trials. It examines the value of the use a plot provides in two trials- Remdesivir for COVID-19 and GDNF for Parkinson’s disease. It demonstrated that asymmetry in the volcano plot can flag extreme events that are less obvious from review of frequency tables, and the dot plot provides a more comprehensive representation by means of a more detailed summary.


Publication Date:

Dec 22, 2020

Statistical methods for the analysis of adverse event data in randomised controlled trials: a scoping review and taxonomy

Phillips R, Sauzet O, Cornelius V

This article examines whether any statistical methods have been specifically developed to analyse prespecified secondary harm outcomes or non-specific emerging adverse events (AEs) in phase II-IV parallel controlled group trials.

BMC Medical Research Methodology

Publication Date:

Nov 30, 2020

A randomised controlled feasibility trial of E-health application supported care vs usual care after exacerbation of COPD: the RESCUE trial

Mal North, Simon Bourne, Ben Green, Anoop J. Chauhan, Tom Brown, Jonathan Winter, Tom Jones, Dan Neville, Alison Blythin, Alastair Watson, Matthew Johnson, David Culliford, Jack Elkes, Victoria Cornelius & Tom M. A. Wilkinson

This paper describes a feasibility study of a digital health intervention with initial evidence that it supports self-management of patients with COPD.

Nature Digital Medicine

Publication Date:

Nov 12, 2020

Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

Michael G. Crooks, Jack Elkes, William Storrar, Kay Roy, Mal North, Alison Blythin, Alastair Watson, Victoria Cornelius, Tom M.A. Wilkinson

This paper describes the result of a trial of a digital health intervention with consideration of the impact of usage on the primary outcome.

ERJ Open Research

Publication Date:

Oct 26, 2020