Advanced concepts in surgical research /

Advanced Concepts in Surgical Research is a practical, reader-friendly guide to planning, conducting, and evaluating solid, evidence-based surgical research that leads to high-quality results. Geared to the investigator who has already mastered basic principles, this book focuses on more advanced to...

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Bibliographic Details
Other Authors:	Bhandari, Mohit, Robioneck, Bernd, Schemitsch, Emil H., Sprague, Sheila, Alt, Volker
Format:	eBook
Language:	English
Published:	Stuttgart ; New York : Thieme, ©2012.
Series:	Thieme flexibook.
Subjects:	Surgery > Research > Methodology. Clinical trials. Surgery > Research > Statistical methods. Biomedical Research > methods. General Surgery. Clinical Trials as Topic. Research Design. Statistics as Topic. Ebooks. Electronic books. Surgery > Research.
Online Access:	Connect to the full text of this electronic book.

Table of Contents:

1. Factorial Randomized Trials
Summary
Introduction
Randomized clinical trial design strategies with multiple interventions
Selecting a factorial randomized design
Conclusion
2. Expertise-based randomized trials
Summary
Introduction
Conventional RCT design
Expertise-based RCT design
Challenges of expertise-based RCTs
Independent assessor
Balanced and consecutive or random contributions to screening pool
Perceived equivalence between practices
Conclusion
3. Randomization systems and technology
Summary
Introduction
Methods of patient allocation
Other considerations
Conclusion
4. Blinding and concealment
Summary
Introduction
Concealment
Blinding
Conclusion
5. Composite outcome in orthopaedics: understanding the concepts
Summary
Introduction
Rationale for use of a composite outcome
Limitations of using composite outcomes
Guidelines for creating a "good" composite outcome
Reporting and interpreting composite outcomes
Conclusion
6. Adjudication of outcomes-systems and approaches
Summary
Introduction
Importance of adjudication
Process of adjudication
Existing methods of adjudication
Web-based adjudication
Conclusion
7. Subgroup analyses
Summary
Introduction
Subgroup analysis defined
Design of a subgroup analysis
Reporting
Interpretation
Conclusion
8. Trial management-advance concepts and systems
Summary
Introduction
Phases of clinical trials
Common considerations in conducting a clinical trial
Trial committees
The search for funding
Conclusion 9. Case-control studies
Summary
Introduction
Definition of a case-control study
Conclusion
10. Cohort studies
Summary
Introduction
Cohort studies in the hierarchy of evidence
Types of cohort study designs
Methods for reducing confounding and assessing causality
A checklist to evaluate or improve the strength of evidence
Conclusion.
11. Survey Design
Summary
Introduction
Identifying a research question
Survey development
Survey design
Using exiting surveys
survey validataion
Pilot testing
Survey administration
Ethical considerations
Financial considerations
Conclusion
12. Qualitative studies
Summary
Introduction
What is qualitative research?
How is qualitative research done?
Conclusion
13. Economic analysis
Summary
Introduction
Theoretical background
Conducting health economics studies
Conclusion
14. Literature searches
Summary
Introduction
When to conduct a literature search
How to conduct a literature search
Study selection
Assessing methodological quality of studies
Data extraction and analysis
Conclusion
15. Summary
Introduction
the P value does not assess the magnitude of a treatment effect
The challenge of comparing results across studies
Types of effect sizes
Confidence intervals for effect sizes
Use of effect size in meta-analysis
Conclusion
16. Fixed effects versus random effects
Summary
Introduction
the data pool: fixed effects versus random effects
Deciding which model to use
Conclusion
17. Heterogeneity
Summary
Introduction
Heterogeneity defined
Identifying heterogeneity
Dealing with heterogeneity
Conclusion
18. Uncovering publicatiion bias
Summary
Introduction
Authors and publication bias
Detecting and adjusting for publication bias
Minimizing the effect of publication bias
A possible solution: trial registers
Conclusion
19. Statiecal pooling
programs and systems
Summary
Introduction
Selectin the appropriate programs and systems: factors to consider
Review of programs and systems
Types of programs and systems
Recommendations
Conclusion
20. Meta-analysis of observational studies
Summary
Introduction
The observational data dilemma
Conclusion
21. Meta-regression
Summary
Introduction
Heterogeneity and meta-regression
Meta-regression mechanics
Interpreting a meta-regression
Limitations of meta-regression
Conclusion
22. Preparing a statistical analysis plan
Summary
Introduction
Data management
Statistical procedures
Data safety and monitoring board
Sample size
Interim analysis
Reports to investigators
Sensitivity analysis
Tables of presentation and publication
Software
Reporting guidelines
General policies
Privacy considerations
Apendices
What is in the literature about SAP?
Conclusion.
24. Survival analysis
Summary
Introduction
Documenting time-to-event (survival) data
the rationale for time-to-event (survival) analysis
Methods for survival analysis
Comparing groups
Practical considerations in the desin of time-to-event studies
Conclusion
25. Interim analyses in randomized trials
Summary
Introduction
Interim analysis defined
Design of an interim analysis
Data monitoring committees
Consequences of stopping early for benefit
Conclusion
26. Conflicts of interest reporting
Summary
Introduction
Legal implications
Types of conflict of interest
Who should disclose conflicts of interest?
When must conflicts of interest be disclosed?
Guidelines and recommendations for disclosure
Why must personal financial interests be disclosed?
Alternatives to disclosure policies
Conclusion
27. Authorship-modern approaches and reporting
Summary
Introduction
Academic stream
Educational stream
Industrial stream
Popular media stream
Conclusion
28. Randomized trials reporting checklists
Summary
Introduction
Consort statement
Nonpharmacological trials
NPT extension to consort statement
CLEAR NPT
Conclusion
29. Observational studies reporting checklists
Summary
Introduction
Checklist for observational studies: the STROBE statement
Guide to investigators: how to used the STROBE statement
The STROBE statement: explanations of checklist items
Conclusion
30. Meta-analysis reporting checklists
Summary
Introduction
Meta-analysis reporting checklists
Conclusion
Resources and contacts for surgical research
Summary
Introduction
Mentorship
Graduate programes
Online courses
Textbooks and journals
Courses and workshops
Contract research organizations
Conclusion
Glossary of terms.