Julian P. T. Higgins is Professor of Evidence Synthesis at Bristol Medical School, University of Bristol, UK. He has worked in methods for systematic review and meta-analysis for over 25 years and acts as Senior Methods Advisor to Cochrane.
 
James Thomas is Professor of Social Research and Policy at the EPPI-Centre, UCL Institute of Education. He has broad interests in systematic review methodology and tools and is Director of the Systematic Reviews Facility for the Department of Health, England.

Contributors xiii
 
Preface xxiii
 
Part One Core methods 1
 
1 Starting a review 3
 
1.1 Why do a systematic review? 3
 
1.2 What is the review question? 4
 
1.3 Who should do a systematic review? 5
 
1.4 The importance of reliability 7
 
1.5 Protocol development 8
 
1.6 Data management and quality assurance 11
 
1.7 Chapter information 12
 
1.8 References 12
 
2 Determining the scope of the review and the questions it will address 13
 
2.1 Rationale for well-formulated questions 13
 
2.2 Aims of reviews of interventions 15
 
2.3 Defining the scope of a review question 16
 
2.4 Ensuring the review addresses the right questions 21
 
2.5 Methods and tools for structuring the review 24
 
2.6 Chapter information 29
 
2.7 References 29
 
3 Defining the criteria for including studies and how they will be grouped for the synthesis 33
 
3.1 Introduction 33
 
3.2 Articulating the review and comparison PICO 35
 
3.3 Determining which study designs to include 51
 
3.4 Eligibility based on publication status and language 60
 
3.5 Chapter information 61
 
3.6 References 61
 
4 Searching for and selecting studies 67
 
4.1 Introduction 68
 
4.2 General issues 68
 
4.3 Sources to search 70
 
4.4 Designing search strategies 79
 
4.5 Documenting and reporting the search process 90
 
4.6 Selecting studies 92
 
4.7 Chapter information 99
 
4.8 References 99
 
5 Collecting data 109
 
5.1 Introduction 109
 
5.2 Sources of data 110
 
5.3 What data to collect 114
 
5.4 Data collection tools 125
 
5.5 Extracting data from reports 130
 
5.6 Extracting study results and converting to the desired format 136
 
5.7 Managing and sharing data 136
 
5.8 Chapter information 137
 
5.9 References 137
 
6 Choosing effect measures and computing estimates of effect 143
 
6.1 Types of data and effect measures 143
 
6.2 Study designs and identifying the unit of analysis 145
 
6.3 Extracting estimates of effect directly 148
 
6.4 Dichotomous outcome data 150
 
6.5 Continuous outcome data 156
 
6.6 Ordinal outcome data and measurement scales 168
 
6.7 Count and rate data 170
 
6.8 Time-to-event data 172
 
6.9 Conditional outcomes only available for subsets of participants 173
 
6.10 Chapter information 174
 
6.11 References 174
 
7 Considering bias and conflicts of interest among the included studies 177
 
7.1 Introduction 177
 
7.2 Empirical evidence of bias 180
 
7.3 General procedures for risk-of-bias assessment 185
 
7.4 Presentation of assessment of risk of bias 188
 
7.5 Summary assessments of risk of bias 188
 
7.6 Incorporating assessment of risk of bias into analyses 190
 
7.7 Considering risk of bias due to missing results 192
 
7.8 Considering source of funding and conflict of interest of authors of included studies 193
 
7.9 Chapter information 199
 
7.10 References 199
 
8 Assessing risk of bias in a randomized trial 205
 
8.1 Introduction 205
 
8.2 Overview of RoB 2 206
 
8.3 Bias arising from the randomization process 212
 
8.4 Bias due to deviations from intended interventions 214
 
8.5 Bias due to missing outcome data 217
 
8.6 Bias in measurement of the outcome 220
 
8.7 Bias in selection of the reported result 221
 
8.

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