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
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
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
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.
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
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
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
Oct 26, 2020
Treatment estimands in clinical trials of patients hospitalised for COVID-19: ensuring trials ask the right questions
Kahan BC, Morris TP, White IR, Tweed CD, Cro S, Dahly D, My Pham T, Esmail H, Babiker A, Carpenter JR.
This articles discusses challenges when defining estimands for trials of patients hospitalised for COVID-19 and makes suggestions for how estimands should be defined for key outcomes.
Sep 8, 2020
How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the Pre-SPEC framework
Kahan BC, Forbes G, Cro S.
This article describes a five-point framework (the Pre-SPEC framework) for designing a pre-specified analysis approach that does not allow p-hacking. The framework is based on the principles in the SPIRIT and ICH-E9 guidelines and is intended to be used in conjunction with these guidelines to help investigators design the statistical analysis strategy for the trial’s primary outcome in the trial protocol.
Sep 6, 2020
A four-step strategy for handling missing outcome data in randomised trials affected by a pandemic
Cro S, Morris TP, Kahan BC, Cornelius VR, Carpenter JR
This paper presents a four-step strategy for handling missing outcome data in the analysis of randomised trials that are ongoing during a pandemic. Settings where treatment effects for a ‘pandemic-free world’ and ‘world including a pandemic’ are of interest are considered.