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Title Advanced concepts in surgical research / edited by Mohit Bhandari, Bernd Robioneck ; associate editor, Emil Schemitsch ; managing editor, Sheila Sprague ; with contributions by Volker Alt [and others]
Published Stuttgart ; New York : Thieme, [2012]
©2012
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Description 1 online resource (xiv, 225 pages) : illustrations (some color)
Series Thieme flexibook
Thieme flexibook.
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
Summary 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 topics such as randomized controlled trials, survey design, observational studies, meta analyses, statistical concepts, reporting of data, and much more
Bibliography Includes bibliographical references and index
Notes Resource; title from t.p. screen (Thieme, viewed Sept. 27, 2012)
Subject Clinical trials.
Surgery -- Research -- Methodology.
Surgery -- Research -- Statistical methods.
Biomedical Research -- methods.
General Surgery.
Clinical Trials as Topic.
Research Design.
Statistics as Topic.
Form Electronic book
Author Alt, Volker.
Bhandari, Mohit.
Robioneck, Bernd.
Schemitsch, Emil H.
Sprague, Sheila.
LC no. 2012019374
ISBN 3131658118
3131670215 (eISBN)
9783131658111
9783131670212 (eISBN)