دانلود کتاب Evidence-based surgery : a gudie to understanding and interpreting the surgical literature

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Preface Contents Contributors 1 History of Evidence-Based Surgery (EBS) References 2 The Steps of Practicing Evidence-Based Surgery (EBS) References 3 Developing a Surgical Clinical Research Question: To Find the Answer in Literature Search or in Pursuing Clinical Research The FINER Criteria Feasible Interesting Novel Ethical Relevant The PICOT Format Patient or Population Intervention Comparative Intervention or Control Outcome Time Horizon References 4 Finding the Evidence Through Searching the Literature Introduction Clinical Scenario Clinical Question Importance of the Question Developing a Search Strategy Identifying Concepts Identifying Search Terms Controlled Vocabulary Boolean Operators Creating a Search Strategy Simple Search Strategy (i.e., Basic) Complex Search Strategy (i.e., Advanced) Limits and Search Filters Choosing Appropriate Resources Pyramid of EBM Resources 6S Pyramid Other Resources Keeping Current Resolution of the Clinical Scenario Conclusion References 5 Hierarchy of Evidence in Surgical Research Introduction Levels of Evidence for Therapeutic Research Clinical Example Levels of Evidence for Diagnostic Research Clinical Example Levels of Evidence for Prognostic Research Clinical Example Levels of Evidence for Economic Research Clinical Example Summary Concluding Remarks Appendix 1: Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence [3] References 6 Evaluating Surgical Interventions Clinical Scenario Search Strategy Appraisal of an Article: Are the Results Valid? Was Patient Assignment Randomized, and was the Randomization Process “Concealed”? Were Study Personnel “Blinded” to Treatment and Apart from the Experimental Intervention, Were the Groups Treated Equally? Were All Patients Who Entered the Trial Accounted for and Was Follow-up Adequate? Were Patients Analyzed According to the “Intention to Treat” Principle? Was the Study Large Enough to Detect a Difference? What Are the Results? What Outcomes Were Used and How Were They Measured? Binary Versus Continuous Outcomes Univariate Testing: Univariable and Multivariable Analyses Multivariable Regression Results: Odds Ratios (OR) and Risk Ratios (RR) How Large Was the Treatment Effect? How Precise was the Estimate of the Treatment Effect? Are the Results Applicable to My Patients? Were the Study Patients Similar to My Patients? Were the Measured Outcomes Clinically Relevant? Are My Surgical Skills Similar to Those of the Study Surgeons? Resolution of the Clinical Scenario References 7 A Primer on Outcome Measures for Surgical Interventions Clinical Scenario Information on Outcome Measures Choosing the Proper Outcome Measure How Can I Know if I Can Trust the Score? How Can I Interpret the Score in Clinical Practice? What Cautions Should I Exercise? Application of Above-Mentioned Concepts to Resolve the Clinical Scenario References 8 Patient-Important Outcome Measures in Surgical Care Scenario Searching the Literature Introduction What is a Patient-Reported Outcome? Other Important Concepts and Definitions How is a PROM Developed? How Do You Evaluate a PROM? Validity Reliability Classical Test Theory Versus Modern Psychometric Test Theory What Are the Different Types of PROMs? Applying the Literature to Patients How Do You Interpret Results? Resolution of the Scenario Appendix 1. Articles found in literature search References 9 Surrogate Endpoints Clinical Scenario Introduction Beware! Confounders Literature Search Are the Results Valid? What Are the Results? Are the Results Applicable to My Patients? Resolution of Clinical Scenario Conclusion References 10 How to Assess an Article that Deals with Health-Related Quality of Life Introduction Clinical Scenario Literature Search Primary Guides Have the Investigators Measured Aspects of Patients’ Lives that Patients Consider Important? Have Important Aspects of HRQL Been Omitted? Are the HRQL Instruments Chosen Valid, Reliable and Responsive? Secondary Guides Were HRQL Assessments Appropriately Timed to Evaluate the Effects of the Surgical Intervention? If There Were Trade-Offs Between Quantity and Quality of Life, Did the Investigators Perform a Economic Analysis? What Were the Results? What Was the Magnitude of the Effect on HRQL? Will the Results Help Me in Caring for My Patients? Will the Information from This Study Help Me Inform My Patients? Resolution of the Scenario References 11 Randomized Controlled Trial Comparing Surgical Interventions Introduction Scenario Literature Search Summary of the Appraised Article Evaluating a Randomized Controlled Trial Are the Results Valid? Learning Curve and Expertise-Based Randomized Controlled Trials Patient Randomization and Allocation Concealment Were Patients, Surgeons, and Researchers Aware of Group Assignment (Blinding)? Were the Patients in Each Group Similar? Intention-to-Treat Analysis Treatment Standardization Sample Size Calculation and Follow-Up What Are the Results? What Was the Impact from the Treatment? How Precise Were the Results? What Now? Generalizability Clinical Relevance What Does This Mean for Me as a Healthcare Provider? Resolving Our Clinical Scenario References 12 How to Assess a Pilot Trial in Surgery Clinical Scenario Definition of Pilot Trials Importance or Necessity of Conducting a Pilot Trial Current Practice in Pilot Trials in the Literature Key Considerations for Designing a Pilot Trial Study Rationale Objective(s) and Outcomes(s) Sample Size Methods of Analysis Criteria of Success Reporting of a Pilot Trial Key Resources for Further References Returning to the Scenario Concluding Remarks Appendix References 13 Non-inferiority Randomized Controlled Trials Clinical Scenario Literature Search Randomized Controlled Trials Non-inferiority RCT Design Conclusion Appendix References 14 Expertise-Based Randomized Controlled Trials Clinical Scenario Introduction Literature Search Are the Results Valid? Was the Learning Curve Taken Into Consideration? Were the Subjects Randomized? Was the Randomization Concealed? Were the Experimental and Control Groups Similar in Terms of Prognostic Factors? Were the Subjects Stratified? Were Subjects Analysed in the Group They Were Initially Randomized into at Enrolment? Was Follow-Up Complete? What are the Results of the Trial? How Were the Results of the Trial Being Measured? How Large Is the Treatment Effect ? Are the Results Applicable to Clinical Practice? Does the Study Represent My Patient Population? Does the Trial Consider All Relevant Patient-Important Outcomes? Do the Benefits of the Procedure Outweigh Any Potential Risks and Costs? Conclusion Resolution of Scenario References 15 The Surgeon’s Guide to Systematic Review and Meta-Analysis Introduction Clinical Scenario Finding the Evidence Are the Results Valid? Did the Review Address a Sensible Clinical Question? Was the Search for Relevant Studies Detailed and Exhaustive? Was Publication Bias Assessed? Were the Primary Studies of High Methodological Quality? Were Assessments of Studies Reproducible? What Are the Results? Were the Results Similar From Study To Study? What Are the Overall Results of the Review? How Precise Were the Results? Can I Apply the Results to My Patients? How Can I Best Interpret the Results and Apply Them to My Patients? Were All Patient-Important Outcomes Considered? Is the Benefit Worth the Potential Costs and Risks? Resolution of the Clinical Scenario Conclusion Appendix 1: Search Results Appendix 2: Prisma Flow Diagram [23, 38] References 16 Prospective and Retrospective Cohort Studies Introduction Clinical Scenario Literature Search Article Summary What are the Study’s Research Question and Clinical Relevance? Are the Results Valid? What is the Study Population? Are the Data Sources Reliable? Are the Data Collection Methods Sound? Do the Authors Provide Clear and Justifiable Definitions of the Primary and Secondary Outcomes? Have the Authors Accounted for Potential Sources of Bias? Is the Statistical Analysis (a) Valid and (b) Described Clearly? What Are the Results? Are Baseline Characteristics of the Exposure Groups Clearly Reported and Accounted For? Are the Results and Relevant Statistics Clearly Stated? How Precise Were Estimates of Effect Size? Are Results Robust to Planned Sensitivity Analyses? Were Subgroup Analyses Used? If So, Were these Specified a Priori and is the Issue of Multiple Testing Addressed? How Can I Interpret these Results in the Context of My Clinical Practice? Are the Results of the Study Placed in the Broader Context of the Clinical Question? Is There a Description of the Existing Literature? Were All Clinically Important Outcomes Considered? Are Limitations of the Study Clearly Described? Resolution of the Clinical Scenario Conclusion References 17 Case-Control Studies Introduction Clinical Scenario Literature Search Appraisal of the Selected Article Are the Results Valid? What Are the Results? How Can I Apply the Results to My Patients in a Clinical Practice? Resolution of the Scenario Additional Information for the Reader Appendix 1 Appendix 2 References 18 Evaluating Case Series in Surgery Introduction Clinical Scenario Literature Search Appraisal of a Surgical Case Series Resolution of Clinical Scenario Conclusion References 19 Quality Improvement and Patient Safety in Surgery Clinical Scenario Literature Search Introduction Background What is Quality Improvement? Is QI Research? Discussion Resolution of the Clinical Scenario Conclusion References 20 Diagnostic Studies in Surgery Introduction Clinical Scenario Literature Search Brief Study Summary Important Aspects of Diagnostic Studies Evaluating the Literature on a Diagnostic Test Appendix 1: Results of Cochrane Literature Review Appendix 2: Results from PubMed Literature Search References 21 How to Assess a Prognostic Study Clinical Scenario How and Why We Measure Prognosis? Study Designs for Prognostic Studies Literature Search Appraising the Surgical Literature on Prognosis Is the Sample Representative? Was Follow-up Sufficiently Long and Complete? Were Objective and Unbiased Outcome Criteria Used? How Likely are the Outcomes to Occur Over Time? How Precise are the Estimates of Likelihood? Can I Apply the Results to my Practice or Patient? Resolution of Clinical Scenario References 22 Decision Analysis and Surgery Clinical Scenario Literature Search Background on Decision Analysis in Surgery Components of Decision Analysis Decision Tree The Outcomes Clinical Application Users’ Guide: A Framework Are the Results Valid? What are the Results? Will the Results Help me in Caring for My Patient? Resolution of the Scenario Appendix 1. Articles Located During Literature Search References 23 Economic Evaluations in Surgery Explanation of the Types of Economic Evaluations and Terminology Used Formulas Used in Economic Evaluations that Inform Adoption of Novel Surgical Interventions For Cost Analysis For Cost-Effectiveness Analysis For Cost–Utility Analysis For Cost–Benefit Analysis Sensitivity Analysis Clinical Scenario Finding the Evidence Are the Results Valid? Did the Analysis Provide a Full Economic Comparison of Healthcare Strategies? Were Relevant Viewpoints Considered? Were All Relevant Clinical Strategies Compared? Were the Costs and Outcomes Properly Measured and Valued? Was Clinical Effectiveness Established? Were Costs Measured Accurately? Were Data on Costs and Outcomes Appropriately Integrated? Was Appropriate Allowance Made for Uncertainties in the Analysis? Are Estimates of Costs and Outcomes Related to the Baseline Risk in the Treatment Population? What Are the Results? What Were the Incremental Costs and Outcomes Between the Two Strategies? Do Incremental Costs and Outcomes Differ Among Subgroups? How Much Does Allowance for Uncertainty Change the Results? Will the Results Help Me in Caring for My Patients? Are the Treatment Benefits Worth the Harms and Costs? Could a Clinician’s Patients Expect Similar Health Outcomes? Can I Expect Similar Costs? Resolution of the Scenario Final Thoughts and the CHEERS Statement References 24 Studies Reporting Harm in Surgery Clinical Scenario Introduction Finding the Evidence Study Appraisal Conclusion Resolution of the Scenario Appendix 1 References 25 Evaluating Surveys and Questionnaires in Surgical Research Introduction Clinical Scenario Literature Search Appraisal of a Surgical Survey Resolution of Clinical Scenario Conclusion References 26 Opinion Pieces in Surgery Clinical Scenario Literature Search Expert Opinion in the Context of Evidence-Based Medicine and Surgery What Is the Value of Expert Opinion? What Are the Limitations of Expert Opinion? Expert Opinion in the Context of the Surgical Literature Does Expert Opinion Apply to Me? Should I Trust an Expert Opinion Clinical Knowledge Technical Knowledge Perception as an Expert Conflict of Interest Resolution of Case Appendix 1: Articles Identified in Literature Search References 27 Simple Statistical Tests and P Values Clinical Scenario Literature Search Chapter Goal Critical Evaluation of the Paper for Reporting RCTs Statistical Tests and P Values Could All of This Be Due to the Play of Chance? Computing the Test Statistic What Does the Number Mean to a Reader? Where Do P Values Come from? Confidence Intervals Software Sensitivity Analysis Multiplicity Resolution of Clinical Scenario Reporting Statistical Findings in the Surgical Literature Appendix 1: Articles Identified in the Literature Search Appendix 2: Sensitivity Analysis for Table 27.3 Using Chi-Square Test and Minitab 18 Appendix 3: Risk of Bias Scoring of the Barberan-Garcia et al. [1] Paper References 28 Confidence Intervals Clinical Scenario Understanding Confidence Intervals Why Are CI’s Different from p-Values? Getting to Estimation Hypothesis Testing How Do We Calculate Confidence Intervals? Why Use Confidence Intervals? Back to Our Scenario Appendix 1 Appendix 2 References 29 Power and Sample Size Clinical Scenario The Importance of Power and Sample Size Article Selection Summary of the Appraised Article by Oh et al. [21] Questions Used to Appraise Resolution of the Scenario Appendix 1 Appendix 2: Using G*Power to Compute Power [30] Appendix 3 Appendix 4 References 30 Subgroup Analyses in Surgery Introduction Clinical Scenario Literature Search Summary of the Appraised Article Appraisal of the Selected Article Resolution of the Scenario Appendix 1 References 31 Introduction to Clinical Practice Guidelines Introduction Clinical Scenario Literature Search Appraisal of Clinical Practice Guidelines: AGREE II and AGREE-REX Tools Are the Results Valid? What Are the Results? How Can I Apply the Results to Patient Care? Resolution of Clinical Scenario Conclusions References Index