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Individual Participant Data Meta-Analysis
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Вернуться на страницу книги Individual Participant Data Meta-Analysis
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Страница 1
Table of Contents
List of Tables
List of Illustrations
Guide
Pages
WILEY SERIES IN STATISTICS IN PRACTICE
Individual Participant Data Meta‐Analysis A Handbook for Healthcare Research
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Acknowledgements
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2 Rationale for Embarking on an IPD Meta‐Analysis Project
Summary Points
2.1 Introduction
2.2 How Does the Research Process Differ for IPD and Aggregate Data Meta‐Analysis Projects?
2.2.1 The Research Aims
2.2.2 The Process and Methods
2.3 What Are the Potential Advantages of an IPD Meta‐Analysis Project?
2.4 What Are the Potential Challenges of an IPD Meta‐Analysis Project?
2.5 Empirical Evidence of Differences Between Results of IPD and Aggregate Data Meta‐Analysis Projects
2.6 Guidance for Deciding When IPD Meta‐Analysis Projects Are Needed to Evaluate Treatment Effects from Randomised Trials
2.6.1 Are IPD Needed to Tackle the Research Question?
2.6.2 Are IPD Needed to Improve the Completeness and Uniformity of Outcomes and Participant‐level Covariates?
2.6.3 Are IPD Needed to Improve the Information Size?
2.6.4 Are IPD Needed to Improve the Quality of Analysis?
2.7 Concluding Remarks
3 Planning and Initiating an IPD Meta‐Analysis Project
Summary Points
3.1 Introduction
3.2 Organisational Approach
3.2.1 Collaborative IPD Meta‐Analysis Project
3.2.2 IPD Meta‐Analysis Projects Using Data Repositories or Data‐sharing Platforms
Box 3.1
Examples of data‐sharing platforms and data repositories
3.3 Developing a Project Scope
3.4 Assessing Feasibility and ‘In Principle’ Support and Collaboration
Box 3.2
Extract of the scope developed for the Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC) IPD meta‐analysis Main Aims
Population
Intervention
Comparators
Outcomes
Study Design
3.5 Establishing a Team with the Right Skills
3.6 Advisory and Governance Functions
3.7 Estimating How Long the Project Will Take
3.8 Estimating the Resources Required
Box 3.3
Typical costs incurred in an IPD meta‐analysis project Staff Costs
General Costs
Fees
Advisory Group Meetings
Patient and Public Involvement Costs
Collaborative Group Meeting
Dissemination Costs
Box 3.4
Examples of research funder support for sharing clinical trial data Cancer Research UK
European Research Council
National Institutes of Health
Medical Research Council
The Patient‐Centered Outcomes Research Institute
Wellcome
3.9 Obtaining Funding
3.10 Obtaining Ethical Approval
3.11 Data‐sharing Agreement
3.12 Additional Planning for Prospective Meta‐Analysis Projects
3.13 Concluding Remarks
4 Running an IPD Meta‐Analysis Project: From Developing the Protocol to Preparing Data for Meta‐Analysis
Summary Points
4.1 Introduction
4.2 Preparing to Collect IPD
4.2.1 Defining the Objectives and Eligibility Criteria
4.2.2 Developing the Protocol for an IPD Meta‐Analysis Project
Box 4.1
Key sections to include in an IPD meta‐analysis protocol
4.2.3 Identifying and Screening Potentially Eligible Trials
Box 4.2
Summary of the sources searched for an IPD meta‐analysis of randomised trials examining recombinant human bone morphogenetic protein‐2 for spinal fusion.
4.2.4 Deciding Which Information Is Needed to Summarise Trial Characteristics
4.2.5 Deciding How Much IPD Are Needed
4.2.6 Deciding Which Variables Are Needed in the IPD
Box 4.3
Example of typical data obtained for trials to be included in an IPD meta‐analysis project
4.2.7 Developing a Data Dictionary for the IPD
4.3 Initiating and Maintaining Collaboration
4.4 Obtaining IPD
4.4.1 Ensuring That IPD Are De‐identified
4.4.2 Providing Data Transfer Guidance
4.4.3 Transferring Trial IPD Securely
4.4.4 Storing Trial IPD Securely
4.4.5 Making Best Use of IPD from Repositories
4.5 Checking and Harmonising Incoming IPD
4.5.1 The Process and Principles
4.5.2 Initial Checking of IPD for Each Trial
4.5.3 Harmonising IPD across Trials
4.5.4 Checking the Validity, Range and Consistency of Variables
4.6 Checking the IPD to Inform Risk of Bias Assessments
4.6.1 The Randomisation Process
4.6.2 Deviations from the Intended Interventions
4.6.3 Missing Outcome Data
4.6.4 Measurement of the Outcome
4.7 Assessing and Presenting the Overall Quality of a Trial
4.8 Verification of Finalised Trial IPD
4.9 Merging IPD Ready for Meta‐Analysis
4.10 Concluding Remarks
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