scholarly journals Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’

2018 ◽  
Vol 3 (2) ◽  
pp. 193-196 ◽  
Author(s):  
Polly Scutt ◽  
Jason P Appleton ◽  
Mark Dixon ◽  
Lisa J Woodhouse ◽  
Nikola Sprigg ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Glyceryl Trinitrate ◽  
Acute Stroke ◽  
Statistical Analysis Plan ◽  
Nitric Oxide Donor ◽  
Experimental Stroke ◽  
Treatment Allocation ◽  
Parallel Group ◽  
Stroke Trial

Rationale: Glyceryl trinitrate, a nitric oxide donor, is a candidate treatment for acute stroke; it lowers blood pressure, does not alter cerebral blood flow or platelet function and is neuroprotective in experimental stroke. The ongoing rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial aims to assess the safety and efficacy of paramedic-delivered glyceryl trinitrate in patients with ultra-acute stroke. Aims and design: The rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial is a multicentre UK-based prospective randomised sham-controlled outcome-blinded parallel-group trial in patients with presumed stroke who present to the ambulance service following a 999 emergency call. The primary outcome is the modified Rankin scale measured by central telephone follow-up at 90 days. Results This paper describes the statistical analysis plan for the rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial and was developed prior to unblinding to treatment allocation. The statistical analysis plan includes details of methods for analyses and unpopulated tables and figures to be included in the primary and other secondary publications. Discussion Statistical analysis plan details what analyses will be done prior to unblinding to treatment allocation to avoid bias in the findings. Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial will determine whether glyceryl trinitrate administered ultra-acutely can improve outcome after stroke. The rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial is registered as ISRCTN26986053.

scholarly journals Baseline characteristics of the 1149 patients recruited into the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) randomized controlled trial

2018 ◽  
Vol 14 (3) ◽  
pp. 298-305 ◽  
Author(s):  
Philip M Bath ◽  
Polly Scutt ◽  
Jason P Appleton ◽  
Mark Dixon ◽  
Lisa J Woodhouse ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Glyceryl Trinitrate ◽  
Acute Stroke ◽  
Controlled Trial ◽  
Nitric Oxide Donor ◽  
Main Trial ◽  
Randomized Controlled ◽  
Baseline Characteristics ◽  
The Uk ◽  
Stroke Trial

Background High blood pressure is common in acute stroke and associated with a worse functional outcome. Glyceryl trinitrate, a nitric oxide donor, lowers blood pressure in acute stroke and may improve outcome. Aims Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) tested the feasibility of performing a UK multicenter ambulance-based stroke trial, and the safety and efficacy of glyceryl trinitrate when administered by paramedics before hospital admission. Methods Paramedic-led ambulance-based multicenter prospective randomized single-blind blinded-endpoint parallel-group controlled trial of transdermal glyceryl trinitrate (given for four days) versus sham in patients with ultra-acute (<4 h) presumed stroke. Data are number (%), median (interquartile range) or mean (standard deviation). Results Recruitment ran from October 2015 to 31 May 2018. A total 1149 patients were recruited from eight UK ambulance services and taken to 54 acute hospitals. Baseline characteristics include: mean age 73 (15) years; female 555 (48%); median time from stroke to randomization 70 (45, 115) min; face-arm-speech scale score 2.6 (0.5); and blood pressure 162 (25)/92 (18) mmHg. The final diagnosis was ischemic stroke 52%, hemorrhagic stroke 13%, Transient Ischemic Attack (TIA) 9%, and mimic 25%. The main trial results will be presented in quarter 4 2018. The results will also be included in updated Cochrane systematic reviews, and individual patient data meta-analyses of all relevant randomized controlled trials. Conclusion It was feasible to perform a multicenter ambulance-based ultra-acute stroke trial in the UK and to treat with glyceryl trinitrate versus sham. The relatively unselected cohort of stroke patients is broadly representative of those admitted to hospital in the UK. Trial registration ISRCTN26986053.

scholarly journals Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial

2017 ◽  
Vol 12 (6) ◽  
pp. 667-670 ◽  
Author(s):  
Laurent Billot ◽  
Mark Woodward ◽  
Hisatomi Arima ◽  
Maree L Hackett ◽  
Paula Muñoz Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Acute Stroke ◽  
Acute Ischemic Stroke ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Head Positioning ◽  
Cluster Randomized ◽  
Stroke Trial

Background There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. Design An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial. Each hospital with an established acute stroke unit (cluster) site was required to recruit up to 140 consecutive cases of acute stroke (one phase of head positioning before immediately crossing over to the other phase of head positioning), including both acute ischemic stroke and intracerebral hemorrhage, in each randomized head position as a ‘business as usual’ policy. Objective To outline in detail the predetermined statistical analysis plan for the study. Methods All accumulated data will be reviewed and formally assessed. Information regarding baseline characteristics of patients, their process of care and management will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons are described. Results A statistical analysis plan was developed that is transparent, verifiable, and predetermined before completion of data collection. Conclusions We developed a predetermined statistical analysis plan for Head Position in Stroke Trial to avoid analysis bias arising from prior knowledge of the findings, in order to reliably quantify the benefits and harms of lying flat versus sitting up early after the onset of acute stroke. Trial registration ClinicalTrials.gov identifier NCT02162017; ANZCTR identifier ACTRN12614000483651

scholarly journals 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

2018 ◽  
Vol 13 (8) ◽  
pp. 863-880 ◽  
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.

scholarly journals Is there a causal relationship between acute stage sensorimotor cortex activity and the development of chronic low back pain? a protocol and statistical analysis plan

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035792
Author(s):  
Luke Jenkins ◽  
Wei-ju Chang ◽  
Valentina Buscemi ◽  
Chelsea Cunningham ◽  
Aidan Cashin ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Statistical Analysis ◽  
Sensorimotor Cortex ◽  
Chronic Low Back Pain ◽  
Directed Acyclic Graph ◽  
Causal Effect ◽  
Statistical Analysis Plan ◽  
Low Back

IntroductionWhy some people develop chronic pain following an acute episode of low back pain is unknown. Recent cross-sectional studies have suggested a relationship between aberrant sensorimotor cortex activity and pain persistence. The UPWaRD (Understanding persistent Pain Where it ResiDes) cohort study is the first prospective, longitudinal investigation of sensorimotor cortex activity in low back pain. This paper describes the development of a causal model and statistical analysis plan for investigating the causal effect of sensorimotor cortex activity on the development of chronic low back pain.Methods and analysisSensorimotor cortex activity was assessed within 6 weeks of low back pain onset using somatosensory evoked potentials and transcranial magnetic stimulation mapping techniques. Chronic low back pain is defined as ongoing pain (Numerical Rating score ≥1) or disability (Roland Morris Disability Questionnaire score ≥3) at 6 months follow-up. Variables that could confound the relationship between sensorimotor cortex activity and chronic low back pain were identified using a directed acyclic graph and content expertise was used to specify known causal paths. The statistical model was developed ‘a priori’ to control for confounding variables identified in the directed acyclic graph, allowing an unbiased estimate of the causal effect of sensorimotor activity in acute low back pain on the development of chronic pain. The statistical analysis plan was finalised prior to follow-up of all participants and initiation of analysis.Ethics and disseminationEthical approval has been obtained from Western Sydney University Human Research Ethics Committee (H10465) and from Neuroscience Research Australia (SSA: 16/002). Dissemination will occur through presentations at national and international conferences and publications in international peer-reviewed journals.Trial registration numberACTRN12619000002189 (retrospectively registered)

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 The effectiveness and safety of antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis

2017 ◽  
Vol 2 ◽  
pp. 120 ◽  
Author(s):  
Katharine Ker ◽  
David Prieto-Merino ◽  
Nikola Sprigg ◽  
Abda Mahmood ◽  
Philip Bath ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Intracranial Haemorrhage ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Statistical Analysis Plan ◽  
Patient Data ◽  
Time To Treatment ◽  
Logistic Regression Models ◽  
Secondary Outcomes

Introduction: The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article presents the statistical analysis plan for an IPD meta-analysis of the effects of antifibrinolytics for acute intracranial haemorrhage. Methods: The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42016052155). We will conduct an individual patient data meta-analysis of randomised controlled trials with 1000 patients or more assessing the effects of antifibrinolytics in acute intracranial haemorrhage. We will assess the effect on two co-primary outcomes: 1) death in hospital at end of trial follow-up, and 2) death in hospital or dependency at end of trial follow-up. The co-primary outcomes will be limited to patients treated within three hours of injury or stroke onset. We will report treatment effects using odds ratios and 95% confidence intervals. We use logistic regression models to examine how the effect of antifibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of antifibrinolytics on secondary outcomes including death, dependency, vascular occlusive events, seizures, and neurological outcomes. Secondary outcomes will be assessed in all patients irrespective of time of treatment. All analyses will be conducted on an intention-to-treat basis. Conclusions: This IPD meta-analysis will examine important clinical questions about the effects of antifibrinolytic treatment in patients with intracranial haemorrhage that cannot be answered using aggregate data. With IPD we can examine how effects vary by time to treatment, bleeding severity, and age, to gain better understanding of the balance of benefit and harms on which to base recommendations for practice.

Sign in / Sign up

Export Citation Format

Share Document