Re–evaluation of the effects of high PEEP with recruitment manoeuvres versus low PEEP without recruitment manoeuvres during general anaesthesia for surgery – Protocol and statistical analysis plan for an individual patient data meta–analysis of PROVHILO, iPROVE and PROBESE

2020 ◽  
Vol 67 (2) ◽  
pp. 76-89
Author(s):  
N.S. Campos ◽  
T. Bluth ◽  
S.N.T. Hemmes ◽  
J. Librero ◽  
N. Pozo ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
General Anaesthesia ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Statistical Analysis Plan ◽  
Patient Data ◽  
High Peep

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 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.

Sign in / Sign up

Export Citation Format

Share Document