scholarly journals ‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Rachel Phillips ◽  
Pippa Oakeshott ◽  
Sarah Kerry-Barnard ◽  
Fiona Reid
Keyword(s):  
College Students ◽  
Statistical Analysis ◽  
High Risk ◽  
Statistical Analysis Plan ◽  
Further Education ◽  
Feasibility Trial ◽  
Rapid Testing ◽  
Cluster Randomised ◽  
Education College

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 Statistical analysis plan for Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – a randomised clinical feasibility trial

2019 ◽  
Author(s):  
Christian Gunge Riberholt ◽  
Christian Gluud ◽  
Janus Christian Jakobsen ◽  
Christian Ovesen ◽  
Jesper Mehlsen ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Statistical Analysis ◽  
Brain Injury ◽  
Standard Care ◽  
Statistical Analysis Plan ◽  
Feasibility Trial ◽  
Tilt Test ◽  
Early Mobilisation ◽  
Head Up Tilt ◽  
Head Up Tilt Test

Abstract Background: Early mobilisation on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomised clinical trials are lacking. Methods: This statistical analysis plan describes the analyses of data collected in a randomised clinical feasibility trial for early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury. Primary feasibility outcomes are the proportion of included participants who were randomised out of all screened patients; the proportion of participants allocated to the experimental intervention who received at least 60% of the planned exercise sessions; and safety outcomes such as severe adverse events and reactions and adverse events and reactions. Exploratory clinical outcomes are suspected unexpected severe adverse reactions; and functional outcomes as assessed by Coma Recovery Scale – Revised at four weeks; Early Functional Ability Scale, and Functional Independence Measure at three months. Exploratory physiological outcomes are electrocardiographic data; mean arterial pressure; and middle cerebral artery blood flow velocity, all obtained during the head-up tilt test. From the first head-up tilt test and five days onwards, a heart rate was measured by continuous electrocardiography. The detailed description includes the statistical analysis including use of multiple imputation and Trial Sequential Analysis. Conclusions: The present statistical analysis plan serves to minimise potential trial reporting bias and selective P hacking and to improve transparency. This feasibility trial will inform design and eventual launching of a larger multicentre randomised clinical trial. Trial registration: ClinicalTrials.gov identifier: NCT02924649. Registered on 3 October 2016.

scholarly journals Statistical analysis plan for early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – a randomised clinical feasibility trial

2019 ◽  
Author(s):  
Christian Gunge Riberholt ◽  
Christian Gluud ◽  
Janus Christian Jakobsen ◽  
Christian Ovesen ◽  
Jesper Mehlsen ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Statistical Analysis ◽  
Brain Injury ◽  
Adverse Events ◽  
Severe Traumatic Brain Injury ◽  
Standard Care ◽  
Statistical Analysis Plan ◽  
Feasibility Trial ◽  
Early Mobilisation ◽  
Head Up Tilt

Abstract Background: Early mobilisation on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomised clinical trials are lacking. Methods: This detailed statistical analysis plan describes the analyses of data collected in a randomised clinical feasibility trial for early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury. Primary feasibility outcomes are the proportion of included participants who were randomised out of all screened patients; the proportion of participants allocated to the experimental intervention who received at least 60% of the planned exercise sessions; and safety outcomes such as adverse events and reactions and serious adverse events and reactions. Exploratory clinical outcomes are suspected unexpected serious adverse reactions; and functional outcomes as assessed by Coma Recovery Scale – Revised at four weeks; Early Functional Ability Scale and Functional Independence Measure at three months. The description includes the statistical analyses including use of multiple imputation and Trial Sequential Analysis. Conclusions: The present statistical analysis plan serves to minimise potential trial reporting bias and selective P hacking and to improve transparency. This trial will inform the feasibility of a potential future multicentre randomised clinical trial. Trial registration: ClinicalTrials.gov identifier: NCT02924649. Registered on 3 October 2016.

scholarly journals Statistical Analysis Plan for the MSK DI AF trial

2021 ◽  
Author(s):  
Laurent Billot ◽  
Denise O'Connor ◽  
Brigit Maguire ◽  
Dina Schram ◽  
Robert Ma ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Diagnostic Imaging ◽  
Randomised Trial ◽  
Statistical Analysis Plan ◽  
Primary Objective ◽  
Audit And Feedback ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Trial Testing ◽  
Australian General Practice

The primary objective of the MSK DI AF trial is to estimate the effectiveness of audit and feedback for reducing diagnostic imaging requests for 11 musculoskeletal imaging services in high requesting GPs in Australia compared with control. It is a 5-arm partial 2 x 2 factorial cluster randomised trial testing variations in the design and delivery of audit and feedback for reducing musculoskeletal diagnostic imaging requests in Australian general practice. This statistical analysis plan pre-specifies all analyses and was prepared while blinded to the randomised allocation.

scholarly journals An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Markus Harboe Olsen ◽  
Britt Morthorst ◽  
Anne Katrine Pagsberg ◽  
Michella Heinrichsen ◽  
Bo Møhl ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emotion Regulation ◽  
Statistical Analysis ◽  
Randomised Clinical Trial ◽  
Statistical Analysis Plan ◽  
Feasibility Trial ◽  
Treatment As Usual ◽  
Link Type ◽  
Self Injury ◽  
Statistical Report

Abstract Background Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13–17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services. Methods The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory – Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where ‘A’ and ‘B’ refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group. Discussion We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility. Trial registration ClinicalTrials.govNCT04243603. Registered on 28 January 2020

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