scholarly journals Statistical Analysis Plan for the Plasma-Lyte 148® versUs Saline Study (PLUS) trial

2020 ◽  
Author(s):  
Laurent Billot ◽  
Simon Finfer ◽  
Sharon Micallef
Keyword(s):  
Statistical Analysis ◽  
Fluid Resuscitation ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Project Manager ◽  
Chief Investigator ◽  
Crystalloid Solution ◽  
Parallel Group ◽  
Detailed Statistical Analysis ◽  
Randomised Controlled

PLUS study is a prospective, multi-centre, parallel group, concealed, blinded, randomised, controlled trial to determine whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline). This detailed statistical analysis plan (SAP) was written by the trial statistician, chief investigator and project manager and approved by the PLUS management committee prior to unblinding and completion of data collection.

scholarly journals The Plasma-Lyte 148 versus Saline (PLUS) statistical analysis plan: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality

2021 ◽  
Vol 23 (1) ◽  
pp. 24-31
Author(s):  
Laurent Billot ◽  
◽  
Rinaldo Bellomo ◽  
Martin Gallagher ◽  
David Gattas ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Randomised Controlled Trial ◽  
Fluid Resuscitation ◽  
Fluid Therapy ◽  
Controlled Trial ◽  
Internal Validity ◽  
Statistical Analysis Plan ◽  
Sensitivity Analyses ◽  
Process Measures ◽  
Randomised Controlled

BACKGROUND AND OBJECTIVE:The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. METHODS: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. RESULTS AND CONCLUSIONS: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.

scholarly journals Statistical Analysis Plan for the HydrOxychloroquine Prophylaxis Evaluation (HOPE) trial

2021 ◽  
Author(s):  
Arpita Ghosh ◽  
Amritendu Bhattacharya ◽  
Vivekanand Jha ◽  
Bharath Kumar Tirupakuzhi Vijayaraghavan ◽  
Abhinav Bassi ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Protective Equipment ◽  
Standard Practice ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Detailed Statistical Analysis ◽  
Frontline Healthcare Workers

HOPE is a prospective, multi-centre, parallel group, concealed, unblinded, randomized, controlled trial to determine whether combination of hydroxychloroquine and standard practice, that is, use of recommended personal protective equipment reduces the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers in hospitals in India as compared to standard practice. This detailed statistical analysis plan was prepared by trial statisticians and approved by the HOPE management committee prior to completion of data collection.

scholarly journals Statistical Analysis Plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit (SuDDICU) study

2020 ◽  
Author(s):  
Laurent Billot ◽  
John Myburgh ◽  
Fiona Goodman ◽  
Simon Finfer ◽  
Ian Seppelt ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Statistical Analysis ◽  
Digestive Tract ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Statistical Analysis Plan ◽  
Selective Decontamination ◽  
Cluster Randomised ◽  
Randomised Controlled

SuDDICU is an international, multicentre, cross-over, cluster randomised controlled trial comparing the effect of selective decontamination of the digestive tract to usual care on hospital mortality in patients receiving mechanical ventilation in the intensive care unit. This manuscript presents the pre-specified statistical analysis plan (SAP) for the SuDDICU trial. The SAP was written without knowledge of the effect of the intervention.

scholarly journals Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): statistical analysis plan for a randomised controlled trial assessing the effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jamie R. Stokes ◽  
Ariel Wang ◽  
Lisa Poulton ◽  
Ines Rombach ◽  
Hemant Pandit ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Randomised Controlled Trial ◽  
Pain Relief ◽  
Knee Replacement ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Liposomal Bupivacaine ◽  
Bupivacaine Hydrochloride ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Up to three quarters of surgical patients receive inadequate pain relief, with 40% of patients reporting severe pain following knee replacement, which may indicate the current pain relief strategies using opiate-based analgesia cannot achieve patient satisfaction. Liposomal bupivacaine is liposome-encapsulated bupivacaine which has been reported to be effective for up to 72 h. The study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK) trial has been designed to assess the effectiveness of peri-articular liposomal bupivacaine and bupivacaine hydrochloride compared with peri-articular bupivacaine hydrochloride alone in the management of post-operative pain following knee replacement. Methods/design The SPAARK trial is a multi-centre, patient-blinded, randomised controlled trial. The co-primary outcomes are post-operative recovery assessed by global QoR-40 scores at 72 h and cumulative pain VAS score from 6 to 72 h following surgery. Longer-term measures of the co-primary outcomes are collected at 6 weeks and 6 and 12 months post randomisation, together with secondary outcomes, i.e. the Oxford Knee Score, and the American Knee Society Score. Cumulative opiate use and fitness for discharge are measured up to 72 h post-surgery. The analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The full SPAARK protocol has already been published. Results The co-primary outcomes will be analysed using multivariate linear regression adjusting for stratification factors and other important prognostic variables, including baseline scores in the case of the QoR-40. The adjusted mean difference between the two groups together with 97.5% confidence intervals will be reported for each of the primary outcomes. Other continuous variables will be assessed using the same method. Binary outcomes will be assessed using chi-squared tests. Discussion The paper provides details of the planned statistical analyses for the SPAARK trial and aims to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. Trial registration ISRCTN54191675. Registered on 13 November 2017.

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