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Field Trials of Health Interventions - A Toolbox (Smith, Morrow, and Ross)

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.

Nursing Medicine

Tác giả: Drue H. Barrett, Angus Dawson, Leonard W. Ortmann
Nhà xuất bản: London School of Hygiene & Tropical Medicine & The Johns Hopkins Bloomberg School of Public Health
Nguồn: LibreTexts
Giấy phép: CC BY-NC
Ngôn ngữ: EN

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01: Introduction to field trials of health interventions
1.01: Scope of the book
1.02: Outline of contents
1.03: Section 3-
1.04: Section 4-
1.05: Section 5-
1.06: Section 6-
02: Types of intervention and their development
2.01: Introduction to types of intervention and their development
2.02: Types of intervention
2.03: Evolution of new intervention products and sequence of study phases
2.04: References
03: Reviewing the literature
3.01: Introduction to reviewing the literature
3.02: Systematic reviews
3.03: Software available for systematic reviews and meta-analyses
3.04: Reporting findings from systematic reviews
3.05: References
04: Trial design
4.01: Analysis monitoring and reporting
4.02: The SPIRIT checklist for standard protocol items for clinical trials
4.03: References
4.04: Introduction to trial design
4.05: Definition of trial objectives
4.06: Selection of interventions
4.07: Allocation of interventions within the trial
4.08: Choice of outcome measures and trial duration
4.09: Trial population
4.10: Implementation
4.11: Data handling
4.12: Quality control
05: Trial size
5.01: Introduction to trial size
5.02: Criteria for determining trial size
5.03: Size to give adequate precision
5.04: Size to give adequate power
5.05: More complex designs
5.06: Interventions allocated to groups
5.07: Other factors influencing choice of trial size
5.08: The consequences of trials that are too small
5.09: Computer software for sample size calculations
5.10: References
06: Ethical considerations
6.01: Introduction to ethical considerations
6.02: Widely accepted ethical principles concerning research on human subjects
6.03: Special issues in field trials in low- and middle-income countries
6.04: References
07: Trial governance
7.01: Introduction to trial governance
7.02: The trial sponsor
7.03: Steering committee
7.04: Data and Safety Monitoring Board
7.05: Trial registration
7.06: References
08: Preparing grant applications
8.01: Further advice
8.02: Introduction to preparing grant applications
8.03: Grant awarding agencies
8.04: Grant types
8.05: Grant awarding process
8.06: Developing the proposal
8.07: Responding to referees
8.08: Funding decision
8.09: Common problems in grant applications
8.10: Roles and responsibilities
8.11: References
09: Community engagement
9.01: Introduction to community engagement
9.02: Planning and initiating community engagement
9.03: Engaging community stakeholders
9.04: Strategy and content of information for communication
9.05: Sustaining community engagement
9.06: References
10: Censuses and mapping
10.01: Introduction to conducting censuses and mapping
10.02: Uses of maps and censuses in intervention trials
10.03: Preparations for a census
10.04: Enumeration
10.05: Processing of census data
10.06: Post-enumeration checks and quality control
10.07: Keeping the census up to date- demographic surveillance
10.08: References
11: Randomization blinding and coding
11.01: Introduction to randomization blinding and coding
11.02: Randomization schemes for individual participants
11.03: Randomization schemes for community or group-based interventions
11.04: Blinding
11.05: Coding systems
11.06: References
12: Outcome measures and case definition
12.01: Introduction to outcome measures and case definition
12.02: Types of outcome measures
12.03: Factors influencing choice of outcome measures
12.04: Variability and quality control of outcome measures
12.05: References
13: Preliminary studies and pilot testing
13.01: Introduction to preliminary studies and pilot testing
13.02: Preliminary studies
13.03: Pilot testing
13.04: References
14: Questionnaires
14.01: Introduction to questionnaires
14.02: The questions
14.03: The questionnaire
14.04: The interviewers
14.05: Data capture
14.06: The interview
14.07: Appendix
14.08: References
15: Social and behavioural research
15.01: Purposes of social and behavioural research in intervention trials
15.02: Social and behavioural research in evaluation
15.03: Commonly used methods in social research
15.04: References
16: Field organization and ensuring data of high quality
16.01: Introduction to field organization and ensuring data of high quality
16.02: Manual of field operations and study diary
16.03: Personnel issues
16.04: Physical location and facilities
16.05: Equipment and supplies
16.06: 16.6-Timetable for field activities
16.07: Ensuring data of high quality
16.08: References
17: Field laboratory methods
17.01: Introduction to field laboratory methods
17.02: Sample collection
17.03: 17.3-Labelling and storage
17.04: Documentation of laboratory procedures
17.05: Quality control and quality assurance
17.06: Accreditation and links between laboratories
17.07: Coding and linkage of results
17.08: Laboratory health and safety
17.09: References
18: Budgeting and accounting
18.01: Introduction to budgeting and accounting
18.02: Budgeting
18.03: Accounting
18.04: Budget monitoring
18.05: Accounts summaries and auditing
18.06: Prevention of fraud and other losses
18.07: Glossary of financial terms
18.08: References
19: Intervention costing and economic analysis
19.01: Introduction to intervention costing and economic analysis
19.02: Types of economic analyses
19.03: Framing the analysis
19.04: Health intervention costs
19.05: Presentation of results
19.06: Generalizability
19.07: Modelling
19.08: Publication of findings
19.09: References
20: Data management
20.01: Introduction to data management
20.02: Before starting to collect data
20.03: Planning the data flow
20.04: Data collection systems
20.05: Managing data
20.06: Archiving
20.07: Preparing data for analysis
20.08: References
21: Methods of analysis
21.01: Introduction to methods of analysis
21.02: Basics of statistical inference
21.03: Statistical analysis plan
21.04: Analysis of proportions
21.05: Analysis of rates
21.06: Analysis of mean values
21.07: Controlling for Confounding Variables
21.08: Analyses when communities have been randomized
21.09: Prevented fraction of disease
21.10: References
22: Phase IV studies
22.01: Introduction to Phase IV studies
22.02: Types of Phase IV study
22.03: The conduct of Phase IV studies
22.04: Examples of real-world effectiveness studies
22.05: References
23: Reporting and Using Trial Results
23.01: Planning communications
23.02: Communication before and during the trial
23.03: Reporting the final results
23.04: From research findings to public health action
23.05: Appendix
23.06: References