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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.

Trials

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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

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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

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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

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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.

BMC Medicine

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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.

BMC Medicine

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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.

BMC Medical Research Methodology

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Public availability and adherence to prespecified statistical analysis approaches was low in published randomized trials

Kahan BC, Ahmad T, Forbes G, Cro S.

This article reviews how often a prespecified statistical analysis approach was publicly available for randomized trials indexed in PubMed. For most published trials, there was insufficient information available to determine whether the results may be subject to p-hacking.

Journal of Clinical Epidemiology

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Understanding current practice, identifying barriers and exploring priorities for adverse event analysis in randomised controlled trials: an online, cross-sectional survey of statisticians from academia and industry

Phillips R, Cornelius V

This article reports the findings of a survey of statisticians that aimed to gain a better understanding of current adverse event analysis practices and explored statisticians' priorities, concerns and barriers when analysing adverse events.

BMJ Open

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Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review

Chis Ster A, Cornelius V, Cro S

This review examines how rescue medication is defined, reported, and accounted for in randomized controlled trials in eczema and asthma populations. We found that while rescue medication is frequently permitted in trials alongside the treatment under evaluation, there is minimal attention or interest in isolating the underlying treatment effect of interest.

Journal of Clinical Epidemiology

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