scholarly journals The aspirin in reducing events in the elderly trial: Statistical analysis plan

2017 ◽  
Vol 13 (3) ◽  
pp. 335-338 ◽  
Author(s):  
Rory Wolfe ◽  
Anne M Murray ◽  
Robyn L Woods ◽  
Brenda Kirpach ◽  
David Gilbertson ◽  
...  
Keyword(s):  
United States ◽  
Statistical Analysis ◽  
Primary Prevention ◽  
Controlled Trial ◽  
The United States ◽  
Statistical Analysis Plan ◽  
Sensitivity Analyses ◽  
Double Blind ◽  
Age Related

Rationale Aspirin has positive and negative effects on a number of age-related chronic conditions and there is uncertainty regarding its role in primary prevention in people aged 70 years and over. Aims To assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy older participants. Design A double-blind, randomized, placebo-controlled primary prevention trial undertaken in Australia and the United States with careful adjudication of endpoints including stroke. Study outcome In Australia 16,703 individuals were recruited through general practices across five states and territories, and in the United States, 2411 participants were recruited through 34 clinical sites across the country. Follow-up of participants will finish at the end of 2017 with average follow-up exceeding 4.25 years per person. Discussion The statistical analysis plan for ASPREE, finalized after closure of recruitment but before the end of patient follow-up, outlines the primary analyses and a range of subgroup and sensitivity analyses. (International Standard Randomized Controlled Trial Number Register ISRCTN83772183 and clinicaltrials.gov Number NCT01038583)

scholarly journals Impact of Fatty Acid Supplementation on Cognitive Performance among United States (US) Military Officers: The Ranger Resilience and Improved Performance on Phospholipid-Bound Omega-3’s (RRIPP-3) Study

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1854
Author(s):  
Bernadette P. Marriott ◽  
Travis H. Turner ◽  
Joseph R. Hibbeln ◽  
Jill C. Newman ◽  
Marcie Pregulman ◽  
...  
Keyword(s):  
United States ◽  
Controlled Trial ◽  
The United States ◽  
Military Officers ◽  
Krill Oil ◽  
Omega 3 ◽  
Double Blind ◽  
Significant Group ◽  
Intention To Treat ◽  
Improved Performance

Studies have assessed omega-3 fatty acids and cognitive decline among older adults and cognitive development among children, although less is known about cognitive or neurological effects among young adults. We examined whether omega-3 supplementation from krill oil could improve cognition and resilience among young military officers compared to a control. This double-blind, placebo-controlled trial enrolled 555 officers (mean age 23.4 ± 2.8, 98.6% male) entering the United States (US) Army Infantry Basic Officer Leaders Course (IBOLC) with the intention to complete the US Ranger Course. Volunteer participants consumed eight dietary supplements daily of krill oil containing 2.3 g omega-3 or control (macadamia nut oil) over an approximate 20-week period. Cognitive functioning, resilience, and mood were assessed during a well-rested period at approximately 14 weeks and after a battlefield simulation at 16 weeks. Blood spot samples were collected to monitor compliance and dietary intake was assessed. All hypotheses were tested using both ‘Intention to Treat’ (ITT) and ‘As Per Protocol’ (APP) approaches. Of the 555 randomized individuals, 245 (44.1%) completed the study. No statistically significant group-by-time interactions indicating treatment effect were found on any outcomes. Poor compliance was indicated by lower than expected omega-3 elevations in the treatment group, and may have contributed to a failure to detect a response.

scholarly journals Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025228 ◽  
Author(s):  
Jennie Johnstone ◽  
Diane Heels-Ansdell ◽  
Lehana Thabane ◽  
Maureen Meade ◽  
John Marshall ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Hospital Length Of Stay ◽  
Sensitivity Analyses ◽  
Ventilator Associated Pneumonia ◽  
Increased Risk ◽  
The Impact

IntroductionVentilator-associated pneumonia (VAP) is the most common healthcare-associated infection in critically ill patients. Prior studies suggest that probiotics may reduce VAP and other infections in critically ill patients; however, most previous randomised trials were small, single centre studies. The Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) aims to determine the impact of the probioticLactobacillus rhamnosusGG on VAP and other clinically important outcomes in critically ill adults.MethodsPROSPECT is a multicentre, concealed, randomised, stratified, blinded, controlled trial in patients ≥18 years old, anticipated to be mechanically ventilated ≥72 hours, in intensive care units (ICUs) in Canada, the USA and Saudi Arabia. Patients receive either 1×1010 colony forming units ofL. rhamnosusGG twice daily or an identical appearing placebo. Those at increased risk of probiotic infection are excluded. The primary outcome is VAP. Secondary outcomes are other ICU-acquired infections includingClostridioides difficileinfection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality. The planned sample size of 2650 patients is based on an estimated 15% VAP rate and will provide 80% power to detect a 25% relative risk reduction.Ethics and disseminationThis protocol and statistical analysis plan outlines the methodology, primary and secondary analyses, sensitivity analyses and subgroup analyses. PROSPECT is approved by Health Canada (#9427-M1133-45C), the research ethics boards of all participating hospitals and Public Health Ontario. Results will be disseminated via academic channels (peer reviewed journal publications, professional healthcare fora including international conferences) and conventional and social media. The results of PROSPECT will inform practice guidelines worldwide.Trialregistration numberNCT02462590; Pre-results.

scholarly journals Statistical analysis plan for the Dex-CSDH trial: a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Annabel Allison ◽  
Ellie Edlmann ◽  
Angelos G. Kolias ◽  
Carol Davis-Wilkie ◽  
Harry Mee ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Subdural Haematoma ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Statistical Analysis Plan ◽  
Chronic Subdural Haematoma ◽  
Double Blind ◽  
Additional Material ◽  
Parallel Group ◽  
The Uk

Abstract Background The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the 6-month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate. Methods and design Dex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a 2-week course of dexamethasone following a CSDH. Seven hundred fifty patients were randomised to either dexamethasone or placebo. The primary outcome is the modified Rankin Scale at 6 months which is dichotomised to favourable (a score of 0–3) versus unfavourable (a score of 4–6). Conclusions This paper and the accompanying additional material describe the statistical analysis plan for the trial. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.

scholarly journals A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial

2021 ◽  
Vol 6 ◽  
pp. 280
Author(s):  
Joseph Donovan ◽  
Trinh Dong Huu Khanh ◽  
Guy E. Thwaites ◽  
Ronald B. Geskus ◽  
Keyword(s):  
Clinical Trial ◽  
Statistical Analysis ◽  
Tuberculous Meningitis ◽  
Controlled Trial ◽  
Clinical Trial Data ◽  
Evidence Base ◽  
Statistical Analysis Plan ◽  
Severe Form ◽  
Hiv Positive ◽  
Double Blind

TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); ‘a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)’. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.

When, If Ever, Is It Ethical to Do Research in Developing Countries That Could Not Be Done Ethically in Developed Countries?

2018 ◽  
pp. 122-144
Author(s):  
Lainie Friedman Ross
Keyword(s):  
United States ◽  
Developing Countries ◽  
Controlled Trial ◽  
Perinatal Transmission ◽  
Developed Countries ◽  
The United States ◽  
Haemophilus Influenzae Type ◽  
Haemophilus Influenzae Type B ◽  
Double Blind ◽  
Double Blind Placebo

In this chapter, three studies performed in the 1990s in three developing countries focused on three neonatal infectious diseases are discussed. The studies were (a) a randomized, double-blind, placebo-controlled trial to reduce perinatal transmission of HIV in Thailand; (b) a randomized, double-blind, placebo-controlled trial to prevent Haemophilus influenzae type b pneumonia in infants in The Gambia; and (c) a nonrandomized cluster trial to reduce neonatal mortality rate from sepsis in infants born at home in India. The chapter examines the ethical controversies raised by these studies and concludes that location and intention matter. Although these studies could not have been performed in the United States or United Kingdom, they were designed to answer a question relevant to the community in which the research was being conducted. Finally, the chapter explores the different ethical scrutiny these studies received and what lessons can be learned.

Effectiveness of the Fun for Wellness Online Behavioral Intervention to Promote Well-Being Actions in Adults With Obesity or Overweight: A Randomized Controlled Trial

2020 ◽  
pp. 1-14
Author(s):  
Seungmin Lee ◽  
Adam McMahon ◽  
Isaac Prilleltensky ◽  
Nicholas D. Myers ◽  
Samantha Dietz ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Well Being ◽  
The United States ◽  
Three Dimensions ◽  
Double Blind ◽  
Randomized Controlled ◽  
Parallel Group

The purpose of this study was to evaluate the effectiveness of the Fun For Wellness (FFW) online intervention to increase well-being actions in adults with obesity in the United States in relatively uncontrolled settings. The FFW intervention is guided by self-efficacy theory. The study design was a large-scale, prospective, double-blind, and parallel-group randomized controlled trial. Data collection occurred at baseline, 30 days after baseline, and 60 days after baseline. Participants (N = 667) who were assigned to the FFW group (nFFW = 331) were provided with 30 days of 24-hr access to FFW. Supportive evidence was provided for the effectiveness of FFW in real-world settings to promote, either directly or indirectly, three dimensions of well-being actions: community, occupational, and psychological. This study shows that theory-based intervention may be effective in promoting well-being actions in adults with obesity in the United States.

Rotigotine improves restless legs syndrome: A 6-month randomized, double-blind, placebo-controlled trial in the United States

2010 ◽  
Vol 25 (11) ◽  
pp. 1675-1683 ◽  
Author(s):  
Wayne A. Hening ◽  
Richard P. Allen ◽  
William G. Ondo ◽  
Arthur S. Walters ◽  
John W. Winkelman ◽  
...  
Keyword(s):  
United States ◽  
Restless Legs Syndrome ◽  
Controlled Trial ◽  
The United States ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Restless Legs

TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial

2019 ◽  
Vol 90 (3) ◽  
pp. e10.4-e11
Author(s):  
E Edlmann ◽  
A Kolias ◽  
E Thelin ◽  
D Gatt ◽  
Y Al-Tamimi ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Statistical Analysis Plan ◽  
Primary Outcome Measure ◽  
Favourable Outcome ◽  
Absolute Difference ◽  
Primary Analysis ◽  
Double Blind ◽  
Intention To Treat

ObjectivesReview recruitment progression and statistical analysis plan for Dex-CSDH trial.DesignA UK multi-centre, randomised, double-blind, placebo-controlled trial of dexamethasone versus placebo for CSDH.SubjectsSymptomatic, adult CSDH patients admitted to a participating neurosurgical unit.MethodsTrial participants receive a 2 week course of dexamethasone in addition to standard care, including surgery. The primary outcome measure is the modified Rankin Scale (mRS) at 6 months. An mRS of 0–3 requires the patient to be independently mobile and we have considered this a favourable outcome, with scores 4–6 (non-mobile) as unfavourable. The primary analysis will be performed on an intention-to-treat basis, estimating the absolute difference between the two treatment arms in the proportions achieving a favourable outcome. Secondary analysis will be done with an ordinal analysis of mRS scores and proportional odds logistic regression of the original mRS score adjusting for baseline covariates (age, GCS).Results629/750 patients (84%) have been recruited to the Dex-CSDH trial which is on-going as of 20-06-2018. Recruitment progress and follow-up at time of presentation will be reviewed alongside full statistical analysis plan.ConclusionsThe Dex-CSDH trial is drawing close to target following excellent recruitment across 22 UK centres. Transparent communication of the statistical analysis plan is essential prior to unblinding of the data. Up-to-date recruitment and primary endpoint completion rates will also be reviewed.

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.

Sign in / Sign up

Export Citation Format

Share Document