Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research

2009 ◽  
pp. 93-112
Keyword(s):  
Statistical Analysis ◽  
Clinical Research ◽  
Statistical Analysis Plan

scholarly journals STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bastiaan C. ter Meulen ◽  
Johanna M. van Dongen ◽  
Marinus van der Vegt ◽  
Henry C. Weinstein ◽  
Raymond W. J. G. Ostelo
Keyword(s):  
Statistical Analysis ◽  
Cost Effectiveness ◽  
Intervention Group ◽  
Statistical Analysis Plan ◽  
Pain Medication ◽  
Oral Pain ◽  
Oral Pain Medication ◽  
Group 2 ◽  
The Cost ◽  
Star Trial

Abstract Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). Methods The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into ‘recovered’ and ‘not recovered’). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0–10), four points for physical functioning (range 0–24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. Discussion This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). Trial registration Dutch National trial register NTR4457 (6 March 2014)

scholarly journals Handling oxygenation targets in ICU patients with COVID‐19 – protocol and statistical analysis plan in the HOT‐COVID trial

2021 ◽  
Author(s):  
Frederik Mølgaard Nielsen ◽  
Thomas Lass Klitgaard ◽  
Elena Crescioli ◽  
Søren Rosborg Aagaard ◽  
Anne Sofie Andreasen ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Icu Patients

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot)

2016 ◽  
Vol 12 (2) ◽  
pp. 211-215
Author(s):  
Verónica V Olavarría ◽  
Hisatomi Arima ◽  
Craig S Anderson ◽  
Alejandro Brunser ◽  
Paula Muñoz-Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Pilot Study ◽  
Acute Ischemic Stroke ◽  
Transcranial Doppler ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Anterior Circulation

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

scholarly journals Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Onur M. Orun ◽  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Ellis Morgan ◽  
Mohana Karlekar ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Specialist Palliative Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Scope Trial

Abstract Background The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. Methods and design The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio. Results The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021. Trial registration ClinicalTrials.gov NCT03436290. Registered on 16 February 2018

scholarly journals Statistical Analysis Plan for the ‘Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke’ (TARDIS) Trial

2014 ◽  
Vol 10 (3) ◽  
pp. 449-451 ◽  
Author(s):  
Philip M. W. Bath ◽  
Katie Robson ◽  
Lisa J. Woodhouse ◽  
Nikola Sprigg ◽  
Robert Dineen ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Ischaemic Stroke ◽  
Statistical Analysis Plan

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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