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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.

Publication Date:

BMJ Open

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.

Publication Date:

Journal of Clinical Epidemiology

Evidence of unexplained discrepancies between planned and conducted statistical analyses: a review of randomised trials

Cro S, Forbes G, Johnson NA, Kahan BC

A review of published randomised trials, identifying a high rate of unexplained discrepancies between the planned and reported statistical methods used to analyse the primary outcome; therefore a need for improved reporting and transparency around statistical methods.

Publication Date:

BMC Medicine

Sensitivity analysis for clinical trials with missing continuous outcome data using controlled multiple imputation: A practical guide. Statistics in Medicine, 2020

Cro S, Morris TP, Kenward MG, Carpenter JR

This tutorial in biostatistics provides an accessible overview of controlled multiple imputation procedures, and a practical guide to their use for missing data sensitivity analysis of a continuous outcome in clinical trials. Worked examples and Stata code are presented.

Publication Date:

Statistics in Medicine

An evaluation of inverse probability weighting using the propensity score for baseline covariate adjustment in smaller population randomised controlled trials with a continuous outcome. BMC Medical Research Methodology, 2020

Raad H, Cornelius V, Chan S, Williamson E, Cro S

This article explores the use of IPTW for baseline covariate adjustment in small sample randomised trials and subsequently provides a caution on the use of IPTW without small sample modifications to the standard error calculation.

Publication Date:

BMC Medical Research Methodology

A randomised placebo controlled trial of anakinra for treating pustular psoriasis: statistical analysis plan for stage two of the APRICOT trial. Trials 2020

Cro, S., Patel, P., Barker, J, Burden D, Griffiths, Lachmann, H, Reynolds, N, Warron, R, Capon, F, Cornelius, V.

This paper reports the statistical analysis plan for the second stage for the APRICOT trial after the first stage adaptation has taken place.

Publication Date:

Trials Journal

Reference‐based multiple imputation for missing data sensitivity analyses in trial‐based cost‐effectiveness analysis. Health Economics 2020

Leurent B, Gomes M, Cro S, Wiles N, Carpenter J.R

This article introduces an accessible statistical method for conducting sensitivity analysis of cost-effectiveness data to address the impact of alternative missing data assumptions.

Publication Date:

Health Economics

The Enhanced Peri-Operative Care for High-risk patients trial: an independent discussion and commentary. BJA 2019.

Cornelius, V,. Johnston, C.

Independent invited commentary on the EPOCH trial to study the effectiveness of a national quality improvement (QI) programme to implement a care pathway to reduce mortality in patients undergoing emergency laparotomy

Publication Date:

British Journal of Anaesthesia

Comparison of Clinical Trial Changes in Primary Outcome and Reported Intervention Effect Size Between Trial Registration and Publication. JAMA Network Open 2019

Chen T, Li C, Qin R, Wang Y, Yu D, Dodd J, Cornelius V.

This review found inconsistencies between registered and published primary outcomes of clinical trials were common, and trials with primary outcome change are likely to have a larger intervention effect than those without. Compared with those without primary outcome change, trials with primary outcome change showed a 16% (pooled ROR, 0.84; 95% CI, 0.73-0.96) larger reported intervention effect size.

Publication Date:

Journal of the American Medical Association

Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ Open 2019

Phillips R, Hazell L, Sauzet O, Cornelius V.

This review highlighted that the collection, reporting and analysis of AE data in clinical trials is inconsistent and RCTs as a source of safety data are underused.

Publication Date:

BMJ Open