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  • Book
    edited by Mohit Bhandari, Bernd Robioneck ; associate editor, Emil Schemitsch ; managing editor, Sheila Sprague ; with contributions by Volker Alt ... [et al.].
    Digital : Thieme MedOne Education2012
    Digital : Thieme MedOne Plastic Surgery2012
    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.