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Adaptive designs in critical care trials: a simulation study

Li W, Cornelius V, Finfer S, Venkatesh B & Billot L.

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.

BMC Medical Research Methodology

Publication Date:

Oct 18, 2023

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Comment on Oberman & Vink: Should we fix or simulate the complete data in simulation studies evaluating missing data methods?

Morris T, White I, Cro S, Bartlett JW, Carpenter JR, My Pham T

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.

Biometrical Journal

Publication Date:

Oct 12, 2023

Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool

Cro S, Kahan BC, Patel A, Henley A, C J, Hellyer P, Kumar M, Rahman Y, Goulão B

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.


Publication Date:

Jul 6, 2023

Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study

Rehal S, Cro S, Phillips PPJ, Fielding K, Carpenter JR.

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

Clinical Trials

Publication Date:

Jun 5, 2023

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery,

Edwards MR, Forbes G, Walker N, Morton DG, Mythen MG, Murray D, Anderson I, Mihaylova B, Thomson A, Taylor M, Hollyman M, Phillips R, Young K, Kahan BC, Pearse RM, Grocott MPW for the FLO-ELA investigators

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.


Publication Date:

May 6, 2023

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials

Junqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, Li T, Mayo-Wilson E, Pham B, Phillips R, Santaguida P, Scherer RW, Gøtzsche PC, Moher D, Ioannidis JPA, Vohra S

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.


Publication Date:

Apr 24, 2023

Future directions of research into harms in randomised controlled trials

Phillips R, Cornelius V

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


Publication Date:

Apr 24, 2023

Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review

Shariq S, Cardoso Pinto AM, Budhathoki SS, Miller M, Cro S

A scoping review which maps the potential barriers and facilitators to the recruitment of disabled people in clinical trials, to identify knowledge gaps and areas for further extensive research.


Publication Date:

Mar 8, 2023

Eliminating ambiguous treatment effects using estimands

Kahan B, Cro S, Li F, O Harhay M

This article introduces estimands to remove ambiguity from reported treatment effects and describe their current use in practice.

American Journal of Epidemiology

Publication Date:

Feb 14, 2023

Practical approaches to Bayesian sample size determination in non-inferiority trials with binary outcomes

Turner RM, Clements MN, Quartagno M, Cornelius V, Cro S, Ford D, Tweed CD, Walker AS, White IR

This paper demonstrates three Bayesian approaches to choosing sample size for non-inferiority trials with binary outcomes and review their advantages and disadvantages

Statistics in Medicine

Publication Date:

Jan 20, 2023

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