scholarly journals Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial

2021 ◽  
Vol 23 (3) ◽  
pp. 262-272
Author(s):  
Jeffrey J Presneill ◽  
◽  
Rinaldo Bellomo ◽  
Kathy Brickell ◽  
Heidi Buhr ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Outcome Data ◽  
Phase 3 ◽  
The United Kingdom ◽  
Parallel Group ◽  
Controlled Treatment ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Early Activity

OBJECTIVE: To describe the protocol and statistical analysis plan for the Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. DESIGN: An international, multicentre, parallel-group, randomised controlled phase 3 trial. SETTING: Intensive care units (ICUs) in Australia, New Zealand, Germany, Ireland, the United Kingdom and Brazil. PATIENTS: 750 adult patients expected to receive mechanical ventilation for more than 48 hours. INTERVENTIONS: Early activity and mobilisation delivered to critically ill patients in an ICU for up to 28 days compared with standard care. MAIN OUTCOME MEASURES: The primary outcome is the number of days alive and out of hospital at 180 days after randomisation. Secondary outcomes include ICU-free days, ventilator-free days, delirium-free days, all-cause mortality at 28 and 180 days after randomisation, and functional outcome at 180 days after randomisation. RESULTS: Recruitment at 46 research sites passed 576 patients in March 2021. Final collection of all 180-day outcome data for the target of 750 patients is anticipated by May 2022. CONCLUSIONS: Consistent with international guidelines, a detailed protocol and prospective analysis plan has been developed for the TEAM III trial. This plan specifies the statistical models for evaluating primary and secondary outcomes, defines covariates for adjusted analyses, and defines methods for exploratory analyses. Application of this protocol and statistical analysis plan to the forthcoming TEAM III trial will facilitate unbiased analyses of the clinical data collected. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03133377.

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.

scholarly journals The Melanoma Genomics Managing Your Risk Study randomised controlled trial: Statistical Analysis Plan

2020 ◽  
Author(s):  
Serigne N Lo ◽  
Amelia K Smit ◽  
David Espinoza ◽  
Anne E Cust
Keyword(s):  
Statistical Analysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Population Level ◽  
Statistical Analysis Plan ◽  
Outcome Data ◽  
Uv Exposure ◽  
Sensitivity Analyses ◽  
System Perspective ◽  
Randomised Controlled

AbstractBackgroundThe Melanoma Genomics Managing Your Risk Study is a randomised controlled trial that aims to evaluate the efficacy of providing information on personal genomic risk of melanoma in reducing ultraviolet radiation (UV) exposure, stratified by traditional risk group (low or high phenotypic risk) in the general population. The primary outcome is objectively measured total daily Standard Erythemal Doses at 12 months. Secondary outcomes include UV exposure at specific time periods, self-reported sun protection and skin-examination behaviors, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the cost-effectiveness of the intervention.ObjectiveTo publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis.MethodsThis SAP describes the data synthesis, analysis principles and statistical procedures for analysing the outcomes from this trial. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data.ResultsThis SAP is consistent with best practice and will enable transparent reporting.ConclusionThis SAP has been developed for the Melanoma Genomics Managing Your Risk Study and will be followed to ensure high-quality standards of internal validity and to minimise analysis bias.Trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12617000691347 (date registered: 15/05/2017).

scholarly journals Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis

2021 ◽  
Vol 23 (3) ◽  
pp. 273-284
Author(s):  
Laurent Billot ◽  
◽  
Jeffrey Lipman ◽  
Stephen J Brett ◽  
Jan J De Waele ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Randomised Controlled Trial ◽  
Data Collection ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Public Access ◽  
Phase 3 ◽  
Randomised Controlled

BACKGROUND: The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 randomised controlled trial comparing continuous infusion with intermittent infusion of β-lactam antibiotics in 7000 critically ill patients with sepsis. OBJECTIVE: To describe a statistical analysis plan for the BLING III study. METHODS: The statistical analysis plan was designed by the trial statistician and chief investigators and approved by the BLING III management committee before the completion of data collection. Statistical analyses for primary, secondary and tertiary outcomes and planned subgroup analyses are described in detail. Interim analysis by the Data Safety and Monitoring Committee (DSMC) has been conducted in accordance with a pre-specified DSMC charter. RESULTS AND CONCLUSIONS: The statistical analysis plan for the BLING III study is published before completion of data collection and unblinding to minimise analysis bias and facilitate public access and transparent analysis and reporting of study findings. TRIAL REGISTRATION: ClinicalTrials.gov Registry NCT03212990.

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 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.

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