The Agents Intervening against Delirium in the Intensive Care Unit Trial (AID‐ICU trial): A detailed statistical analysis plan

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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Statistical analysis plan for the Prophylactic Melatonin for Delirium in Intensive Care (ProMEDIC): a randomised controlled trial

Trials ◽

10.1186/s13063-020-04981-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Bradley Wibrow ◽

F. Eduardo Martinez ◽

Andrew Ford ◽

Erin Kelty ◽

Kevin Murray ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Statistical Analysis ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Brain Dysfunction ◽

Primary Objective ◽

Trial Registration ◽

Clinical Trial Registry ◽

Randomised Controlled

Abstract Rationale Delirium is defined as acute organic brain dysfunction characterised by inattention and disturbance of cognition. It is common in the intensive care unit and is associated with poorer outcomes. Good quality sleep is important in the prevention and management of delirium. Melatonin is a natural hormone secreted by the pineal gland which helps in the regulation of the sleep-wake cycle. It is possible that melatonin supplementation in intensive care improves sleep and prevents delirium. Methods and design The ‘Prophylactic Melatonin for Delirium in Intensive Care’ study is a multi-centre, randomised, double-blinded, placebo-controlled trial. The primary objective of this study is to determine whether melatonin given prophylactically decreases delirium in critically ill patients. A total of 850 ICU patients have been randomised (1:1) to receive either melatonin or a placebo. Participants were monitored twice daily for symptoms of delirium. Results This paper and the attached additional files describe the statistical analysis plan (SAP) for the trial. The SAP has been developed and submitted for publication before the database has been locked and before the treatment allocation has been unblinded. The SAP contains details of analyses to be undertaken, which will be reported in the primary and secondary publications. Discussion The SAP details the analyses that will be done to avoid bias coming from knowledge of the results in advance. This trial will determine whether prophylactic melatonin administered to intensive care unit patients helps decrease the rate and the severity of delirium. Trial registration Australian and New Zealand Clinical Trial Registry (ANZCTR) ACTRN1261600043647, registration date: 06 April 2016. WHO Trial Number – U1111-1175-1814

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Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy

International Journal of Stroke ◽

10.1177/1747493018790055 ◽

2018 ◽

Vol 13 (8) ◽

pp. 863-880 ◽

Cited By ~ 1

Author(s):

Erin Godecke ◽

Tapan Rai ◽

Dominique A Cadilhac ◽

Elizabeth Armstrong ◽

Sandy Middleton ◽

...

Keyword(s):

Clinical Trials ◽

Statistical Analysis ◽

Statistical Analysis Plan ◽

Steering Committee ◽

Aphasia Therapy ◽

Detailed Statistical Analysis ◽

Registration Number ◽

Clinical Trials Registry ◽

Potential Trial ◽

Stroke Trial

Background Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.

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Detailed statistical analysis plan for the pulmonary protection trial

Trials ◽

10.1186/1745-6215-15-510 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 1

Author(s):

Katrine B Buggeskov ◽

Janus C Jakobsen ◽

Niels H Secher ◽

Thomas Jonassen ◽

Lars W Andersen ◽

...

Keyword(s):

Statistical Analysis ◽

Statistical Analysis Plan ◽

Detailed Statistical Analysis ◽

Pulmonary Protection

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The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial

Trials ◽

10.1186/s13063-016-1633-5 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 4

Author(s):

Ying Zhang ◽

Jin Sun ◽

Yun-Jiao Zhang ◽

Qian-Yun Chai ◽

Kang Zhang ◽

...

Keyword(s):

Insulin Resistance ◽

Randomized Controlled Trial ◽

Statistical Analysis ◽

Polycystic Ovary ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Ovary Syndrome ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Detailed Statistical Analysis

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Relationship of serum procalcitonin levels and c-reactive protein levels in newborns with sepsis in different types of respiratory support in intensive care unit

Archives of Public Health ◽

10.3889/aph.2021.5995 ◽

2021 ◽

Vol 13 (1) ◽

pp. 39-47

Author(s):

Aspazija Sofijanova ◽

Sonja Bojadzieva ◽

Silvana Naunova- Timovska ◽

Hristina Mandzukovska ◽

Elizabeta Shuperliska ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Statistical Analysis ◽

Clinical Signs ◽

Severe Infection ◽

Predictive Values ◽

Mortality And Morbidity ◽

Protein Levels ◽

Time Period ◽

High Level

Sepsis in newborns with RDSy and asphyxia is essential; it is a life-threatening condition and still represents an important cause of mortality and morbidity. The aim of this study was to evaluate the predictive values of procalcitonin (PCT) as an early diagnostic and prognostic biochemical marker for sepsis in newborns with RDS and asphyxia. Material and methods: The study was designed as prospective and we examined 110 newborns with proven sepsis admitted in the Intensive Care Unit at the University Clinic of Pediatrics – Skopje in the period between December 2018 and Јanuary 2021. Procalcitonin levels were measured by using the immunoassay system Vidas based on the ELFA principles. The newborns with proven sepsis were divided into two groups. The first group comprised 55 newborns with RDS and proven sepsis and the second group included 55 newborns with asphyxia and proven sepsis. The statistical analysis confirmed significantly different values of PCT in the analyzed time period in first group of newborns with RDS and proven sepsis, p<0.001. The highest average values (40.37±53.79) were measured on admission with a high level of peak compared to the second group of newborns with asphyxia and proven sepsis. The statistical analysis confirmed significantly different values of PCT in the analyzed time period in the first group of newborns with RDS and proven sepsis with mechanical ventilation (MV) and bubble continuous positive airway pressure (BCPAP) compared to the second group of newborns with asphyxia and proven sepsis, p<0.001. PCT is a promising sepsis marker in newborns with RDSy, capable of complementing clinical signs and routine laboratory parameters suggestive of severe infection at the time of ICU admission.

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Pharmacy Trial Program – Asthma and Rhinitis Control (PTP-ARC) trial: Statistical Analysis Plan

10.31219/osf.io/mjzrn ◽

2020 ◽

Author(s):

Laurent Billot ◽

Sarah Serhal ◽

Carol Armour

Keyword(s):

Statistical Analysis ◽

Health Care Services ◽

Statistical Analysis Plan ◽

Key Factors ◽

Uncontrolled Asthma ◽

Care Services ◽

Reliever Medication ◽

Primary Health Care Services ◽

Detailed Statistical Analysis

The Asthma and Rhinitis Control (PTP-ARC) is one of several Australian Government funded trials being conducted under the PTP. It aims to address the need to improve clinical outcomes for the population at risk of uncontrolled asthma, by extending the role of pharmacists in the delivery of primary health care services through a community pharmacy. This intervention targets three key factors associated with uncontrolled asthma: (i) poor adherence, characterised by underuse of preventer medication and/or overuse of reliever medication, (ii) suboptimal inhaler technique and/or (iii) uncontrolled allergic rhinitis. This document is a detailed statistical analysis plan which was finalised before unblinding.

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Statistical Analysis Plan for the Lifestyle InterVention IN Gestational Diabetes (LIVING) trial

10.31219/osf.io/gu3qp ◽

2021 ◽

Author(s):

Amritendu Bhattacharya ◽

Laurent Billot ◽

Anushka Patel ◽

Nikhil Tandon

Keyword(s):

Statistical Analysis ◽

Gestational Diabetes ◽

Lifestyle Intervention ◽

South Asian ◽

Statistical Analysis Plan ◽

Culturally Appropriate ◽

Asian Countries ◽

Intervention Programme ◽

Detailed Statistical Analysis ◽

Secondary Endpoints

The LIVING trial aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. This statistical analysis plan provides the details of all the pre-specified analyses including the analysis of all primary and secondary endpoints. This detailed statistical analysis plan (SAP) was written by the statisticians and chief investigators prior to unblinding and database lock.

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