A collaborative sequential meta-analysis of individual patient data from randomized trials of endovascular therapy and tPA vs. tPA alone for acute ischemic stroke: ThRombEctomy And tPA (TREAT) analysis: statistical analysis plan for a sequential meta-analysis performed within the VISTA-Endovascular collaboration

2015 ◽  
Vol 10 (SA100) ◽  
pp. 136-144 ◽  
Author(s):  
Rachael L. Macisaac ◽  
Pooja Khatri ◽  
Martin Bendszus ◽  
Serge Bracard ◽  
Joseph Broderick ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Acute Ischemic Stroke ◽  
Endovascular Therapy ◽  
Randomized Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Statistical Analysis Plan ◽  
Patient Data ◽  
Treat Analysis

scholarly journals TCT-761 Effectiveness of Endovascular therapy for Acute Ischemic Stroke-Evidence from a Meta-analysis of Randomized Trials

2015 ◽  
Vol 66 (15) ◽  
pp. B309-B310
Author(s):  
Partha Sardar ◽  
Saurav Chatterjee ◽  
Anwar Tandar ◽  
Amartya Kundu ◽  
Ramez Nairooz ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Endovascular Therapy ◽  
Randomized Trials ◽  
Meta Analysis

scholarly journals Streptokinase in Acute Ischemic Stroke: An Individual Patient Data Meta-Analysis

Stroke ◽  
2000 ◽  
Vol 31 (7) ◽  
pp. 1555-1560 ◽  
Author(s):  
C. Cornu ◽  
F. Boutitie ◽  
L. Candelise ◽  
J. P. Boissel ◽  
G. A. Donnan ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data

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.

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

2018 ◽  
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 ◽  
Intention To Treat ◽  
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 within 30 days of randomisation, and 2) Death  or dependency at final follow-up within 90 days of randomisation. 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.

scholarly journals Targeting Aspirin in Acute Disabling Ischemic Stroke: An Individual Patient Data Meta-Analysis of Three Large Randomized Trials

2015 ◽  
Vol 10 (7) ◽  
pp. 1024-1030 ◽  
Author(s):  
Douglas D. Thompson ◽  
Gordon D. Murray ◽  
Livia Candelise ◽  
Zhengming Chen ◽  
Peter A. G. Sandercock ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Randomized Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data

scholarly journals Effects of alteplase for acute stroke according to criteria defining the European Union and United States marketing authorizations: Individual-patient-data meta-analysis of randomized trials

2017 ◽  
Vol 13 (2) ◽  
pp. 175-189 ◽  
Author(s):  
Werner Hacke ◽  
Patrick Lyden ◽  
Jonathan Emberson ◽  
Colin Baigent ◽  
Lisa Blackwell ◽  
...  
Keyword(s):  
United States ◽  
European Union ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Randomized Trials ◽  
Individual Patient Data ◽  
Time Window ◽  
Meta Analysis ◽  
Hazard Ratios ◽  
Intravenous Alteplase

Background The recommended maximum age and time window for intravenous alteplase treatment of acute ischemic stroke differs between the Europe Union and United States. Aims We compared the effects of alteplase in cohorts defined by the current Europe Union or United States marketing approval labels, and by hypothetical revisions of the labels that would remove the Europe Union upper age limit or extend the United States treatment time window to 4.5 h. Methods We assessed outcomes in an individual-patient-data meta-analysis of eight randomized trials of intravenous alteplase (0.9 mg/kg) versus control for acute ischemic stroke. Outcomes included: excellent outcome (modified Rankin score 0–1) at 3–6 months, the distribution of modified Rankin score, symptomatic intracerebral hemorrhage, and 90-day mortality. Results Alteplase increased the odds of modified Rankin score 0–1 among 2449/6136 (40%) patients who met the current European Union label and 3491 (57%) patients who met the age-revised label (odds ratio 1.42, 95% CI 1.21−1.68 and 1.43, 1.23−1.65, respectively), but not in those outside the age-revised label (1.06, 0.90−1.26). By 90 days, there was no increased mortality in the current and age-revised cohorts (hazard ratios 0.98, 95% CI 0.76−1.25 and 1.01, 0.86–1.19, respectively) but mortality remained higher outside the age-revised label (1.19, 0.99–1.42). Similarly, alteplase increased the odds of modified Rankin score 0-1 among 1174/6136 (19%) patients who met the current US approval and 3326 (54%) who met a 4.5-h revised approval (odds ratio 1.55, 1.19−2.01 and 1.37, 1.17−1.59, respectively), but not for those outside the 4.5-h revised approval (1.14, 0.97−1.34). By 90 days, no increased mortality remained for the current and 4.5-h revised label cohorts (hazard ratios 0.99, 0.77−1.26 and 1.02, 0.87–1.20, respectively) but mortality remained higher outside the 4.5-h revised approval (1.17, 0.98–1.41). Conclusions An age-revised European Union label or 4.5-h-revised United States label would each increase the number of patients deriving net benefit from alteplase by 90 days after acute ischemic stroke, without excess mortality.

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

2019 ◽  
Vol 2 ◽  
pp. 120
Author(s):  
Katharine Ker ◽  
David Prieto-Merino ◽  
Nikola Sprigg ◽  
Abda Mahmood ◽  
Philip Bath ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Head Injury ◽  
Intracranial Haemorrhage ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Statistical Analysis Plan ◽  
Patient Data ◽  
Time To Treatment ◽  
Logistic Regression Models ◽  
Secondary Outcomes

Abstract Introduction: The Anti-fibrinolytics Trialists Collaboration aims to increase knowledge about the effectiveness and safety of anti-fibrinolytic 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 anti-fibrinolytics for acute intracranial haemorrhage. Methods: The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42019128260). We will conduct an individual patient data meta-analysis of randomised controlled trials with 500 patients or more assessing the effects of anti-fibrinolytics in acute intracranial haemorrhage. The primary outcomes will be 1) death from stroke or head injury within 30 days of randomisation, and 2) death from stroke or head injury, or dependency within 90 days of randomisation. The 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 anti-fibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of anti-fibrinolytics 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 anti-fibrinolytic 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.

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 Age and organ damage correlate with poor survival in myeloma patients: meta-analysis of 1435 individual patient data from 4 randomized trials

Haematologica ◽  
2013 ◽  
Vol 98 (6) ◽  
pp. 980-987 ◽  
Author(s):  
S. Bringhen ◽  
M. V. Mateos ◽  
S. Zweegman ◽  
A. Larocca ◽  
A. P. Falcone ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Organ Damage ◽  
Patient Data ◽  
Poor Survival
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