Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in “field trials”, which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial design and conduct are discussed fully and in sufficient detail for the text to be used as a “toolbox” by field investigators. The toolbox has now been extensively tested through use of the first two editions and this third edition is a comprehensive revision, incorporating the many developments that have taken place with respect to trials since 1996 and involving more than 30 contributors. Most of the chapters have been extensively revised and 7 new chapters have been added.

Contents

• Dedication
• Foreword to the third edition
• Preface to the third edition
• Contributors
• Acronyms
• Chapter 1. Introduction to field trials of health interventions
  • 1. Scope of the book
  • 2. Outline of contents
• Chapter 2. Types of intervention and their development
  • 1. Introduction to types of intervention and their development
  • 2. Types of intervention
  • 3. Evolution of new intervention products and sequence of study phases
  • References
• Chapter 3. Reviewing the literature
  • 1. Introduction to reviewing the literature
  • 2. Systematic reviews
  • 3. Software available for systematic reviews and meta-analyses
  • 4. Reporting findings from systematic reviews
  • References
• Chapter 4. Trial design
  • 1. Introduction to trial design
  • 2. Definition of trial objectives
  • 3. Selection of interventions
  • 4. Allocation of interventions within the trial
  • 5. Choice of outcome measures and trial duration
  • 6. Trial population
  • 7. Implementation
  • 8. Data handling
  • 9. Quality control
  • 10. Analysis, monitoring, and reporting
  • 11. The ‘SPIRIT’ checklist for standard protocol items for clinical trials
  • References
• Chapter 5. Trial size
  • 1. Introduction to trial size
  • 2. Criteria for determining trial size
  • 3. Size to give adequate precision
  • 4. Size to give adequate power
  • 5. More complex designs
  • 6. Interventions allocated to groups
  • 7. Other factors influencing choice of trial size
  • 8. The consequences of trials that are too small
  • 9. Computer software for sample size calculations
  • References
• Chapter 6. Ethical considerations
  • 1. Introduction to ethical considerations
  • 2. Widely accepted ethical principles concerning research on human subjects
  • 3. Special issues in field trials in low- and middle-income countries
  • References
• Chapter 7. Trial governance
  • 1. Introduction to trial governance
  • 2. The trial sponsor
  • 3. Steering committee
  • 4. Data and Safety Monitoring Board
  • 5. Trial registration
  • References
• Chapter 8. Preparing grant applications
  • 1. Introduction to preparing grant applications
  • 2. Grant awarding agencies
  • 3. Grant types
  • 4. Grant awarding process
  • 5. Developing the proposal
  • 6. Responding to referees
  • 7. Funding decision
  • 8. Common problems in grant applications
  • 9. Roles and responsibilities
  • 10. Further advice
  • Reference
• Chapter 9. Community engagement
  • 1. Introduction to community engagement
  • 2. Planning and initiating community engagement
  • 3. Engaging community stakeholders
  • 4. Strategy and content of information for communication
  • 5. Sustaining community engagement
  • References
• Chapter 10. Censuses and mapping
  • 1. Introduction to conducting censuses and mapping
  • 2. Uses of maps and censuses in intervention trials
  • 3. Preparations for a census
  • 4. Enumeration
  • 5. Processing of census data
  • 6. Post-enumeration checks and quality control
  • 7. Keeping the census up to date: demographic surveillance
  • References
• Chapter 11. Randomization, blinding, and coding
  • 1. Introduction to randomization, blinding, and coding
  • 2. Randomization schemes for individual participants
  • 3. Randomization schemes for community or group-based interventions
  • 4. Blinding
  • 5. Coding systems
  • References
• Chapter 12. Outcome measures and case definition
  • 1. Introduction to outcome measures and case definition
  • 2. Types of outcome measures
  • 3. Factors influencing choice of outcome measures
  • 4. Variability and quality control of outcome measures
  • References
• Chapter 13. Preliminary studies and pilot testing
  • 1. Introduction to preliminary studies and pilot testing
  • 2. Preliminary studies
  • 3. Pilot testing
  • References
• Chapter 14. Questionnaires
  • 1. Introduction to questionnaires
  • 2. The questions
  • 3. The questionnaire
  • 4. The interviewers
  • 5. Data capture
  • 6. The interview
  • References
  • Appendix 14.1. Options for recording responses on a questionnaire
  • Appendix 14.2. Pre-coded responses which are mutually exclusive
  • Appendix 14.3. Pre-coded responses which are not mutually exclusive
  • Appendix 14.4. Questions with a ‘skip’ instruction
  • Appendix 14.5. Recording of multiple items of information for direct computer entry
  • Appendix 14.6. ‘Open’ questions
  • Appendix 14.7. Questions for self-completion by the respondent
  • Appendix 14.8. Questionnaires on a mobile phone
  • Appendix 14.9. Collecting geolocation data on a mobile phone
  • Appendix 14.10. Recording a laboratory test result on a mobile phone
• Chapter 15. Social and behavioural research
  • 1. Purposes of social and behavioural research in intervention trials
  • 2. Social and behavioural research in evaluation
  • 3. Commonly used methods in social research
  • References
• Chapter 16. Field organization and ensuring data of high quality
  • 1. Introduction to field organization and ensuring data of high quality
  • 2. Manual of field operations and study diary
  • 3. Personnel issues
  • 4. Physical location and facilities
  • 5. Equipment and supplies
  • 6. Timetable for field activities
  • 7. Ensuring data of high quality
  • References
• Chapter 17. Field laboratory methods
  • 1. Introduction to field laboratory methods
  • 2. Sample collection
  • 3. Labelling and storage
  • 4. Documentation of laboratory procedures
  • 5. Quality control and quality assurance
  • 6. Accreditation and links between laboratories
  • 7. Coding and linkage of results
  • 8. Laboratory health and safety
  • References
• Chapter 18. Budgeting and accounting
  • 1. Introduction to budgeting and accounting
  • 2. Budgeting
  • 3. Accounting
  • 4. Budget monitoring
  • 5. Accounts summaries and auditing
  • 6. Prevention of fraud and other losses
  • 7. Glossary of financial terms
  • References
• Chapter 19. Intervention costing and economic analysis
  • 1. Introduction to intervention costing and economic analysis
  • 2. Types of economic analyses
  • 3. Framing the analysis
  • 4. Health intervention costs
  • 5. Presentation of results
  • 6. Generalizability
  • 7. Modelling
  • 8. Publication of findings
  • References
• Chapter 20. Data management
  • 1. Introduction to data management
  • 2. Before starting to collect data
  • 3. Planning the data flow
  • 4. Data collection systems
  • 5. Managing data
  • 6. Archiving
  • 7. Preparing data for analysis
  • References
• Chapter 21. Methods of analysis
  • 1. Introduction to methods of analysis
  • 2. Basics of statistical inference
  • 3. Statistical analysis plan
  • 4. Analysis of proportions
  • 5. Analysis of rates
  • 6. Analysis of mean values
  • 7. Controlling for confounding variables
  • 8. Analyses when communities have been randomized
  • 9. Prevented fraction of disease
  • References
• Chapter 22. Phase IV studies
  • 1. Introduction to Phase IV studies
  • 2. Types of Phase IV study
  • 3. The conduct of Phase IV studies
  • 4. Examples of real-world effectiveness studies
  • References
• Chapter 23. Reporting and using trial results
  • 1. Planning communications
  • 2. Communication before and during the trial
  • 3. Reporting the final results
  • 4. From research findings to public health action
  • References
  • Appendix 23.1. Guidance on how to write a scientific paper reporting the results of a trial
  • Appendix 23.2. Checklist of information to include when reporting a randomized trial
  • Appendix 23.3. A communication action plan for a trial (Annabelle South, Aoife Doyle, David Ross, personal communication)