From Validity Detectives Mike & Sheri—
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Volume: Quality of Evidence

• Observational Studies
• Primary Studies & General Concepts
• Screening & Diagnostic Studies
• Secondary Studies
• Secondary Sources

Volume: Use of Evidence

• Quality of Care—From Variation to Improvement
• Reporting the Evidence
• Applying the Evidence

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Volume Contents

Use of Evidence

Quality of Care — From Variation to Improvement

• The Volume of Inappropriate Care in the US
• More On Therapies Becoming “Routine Clinical Practice” Without Evidence & Why We Are Doing This Work: Radiofrequency for the Treatment of Gastro-esophageal Reflux Disease Example
• Reversal of Established Practices—Unringing the Bell
• Variations in Experts' Recommendations
• Variations in Care Costs and Care Quality: Evidence (Lack of), Quality of Care and Physician Revenue: “The Cost Conundrum: What a Texas town can teach us about health care” by Atul Gawande
• Variations in Clinicians' Estimates of Pretest Probabilities
• Underuse of Proven Interventions
• Class Effect: Caution Urged

Reporting the Evidence

• The Consort Statement: Consolidated Standards of Reporting Trials —CONSORT: Update 2010
• Pointers on Number-Needed-to-Treat
• Untrustable Abstracts & P-Values
• The Cost of Being in a Hurry: Reading Only Abstracts May Mislead You
• CONSORT Statement on Harms
• When There is No Evidence
• TREND: Reporting Standards for Non-randomized Studies
• Poorly Written Papers
• Media Heyday: Aspirin and (Potentially) Reduced Risk of Breast Cancer

Applying the Evidence

• Delfini Commentary on "Lies, Damned Lies, and Medical Science," by David H. Freedman, The Atlantic, November 2010
• Gastro-esophageal Reflux Disease (GERD), The Purple Pill and Plenty of Pennies
• Guidelines & Effectiveness of Implementation
• Oregon Preferred Drug List
• Successful Evidence-based QI Project: Diabetes Management at Dreyer Medical Clinical
• External Validity: Case of the Carotid Stent
• Success Story at the Delfini Project Showcase: Nephrology Clinical Practice Guideline for Primary Care
• Also see On the Same Page™ for applying the evidence through patient-centered resources

Quality of Evidence

Observational Studies

• Cause & Effect Conclusions from Observations
• More on the Problem with Drawing Cause-Effect Conclusions from Observational Studies
• Bias in Observational Studies — More on HRT in Menopause

Primary Studies & General Concepts

• See also Delfini Commentary on "Lies, Damned Lies, and Medical Science," by David H. Freedman, The Atlantic, November 2010 including a link to the article and our published Letter to the Editor, "How to Evaluate Medical Science," The Atlantic, January/February 2011
• Quality of Studies: Lower Quality = Greater Effect Size
  • More: Overestimation of Effect Size in Studies of Low Quality
• Key Clinical Questions & PICO
• Must Clinical Trials be Randomized? A Look at Minimization Methods
• Concealment of Allocation
• Blinding and RCTs
• Blinding and Objective Outcomes
  • Open-Label Trials and Importance of Blinding (Even with Hard Outcomes)
• Blinding in Surgery Trials
• The Importance of Blinded Assessors in RCTs
• Testing the Success of Blinding
• Attrition Bias: Intention-to-Treat Basics
• Intention-to-Treat Analysis & the Effects of Various Methods of Handling Missing Subjects: The Case of the Compelling Rationale
• See also Bell's Palsy Update for the addition of instructional slides to demonstrate how to perform a conservative intention-to-treat (ITT) analysis. [This is a primary studies issue, but is stored in secondary studies for historical reasons concerning our initial commentary on a narrative review.]
• Intention-to-Treat & Imputing Missing Variables: Last-Observation-Carried-Forward (LOCF)—When We Might Draw Reasonable Conclusions
• Intention-to-Treat Analysis & Censoring: Rofecoxib Example
• Intention-to-Treat Analysis: Misreporting and Migraine
• Missing Data Points: Difference or No Difference
  • Attrition Bias Caution: Non-differential Loss Between Groups Can Threaten Validity
  • Attrition Bias and Baseline Characteristic Testing (Esp for Non-Dichotomous Variables)
  • Attrition Bias & A Biostatistician Weighs In: Dr. Steve Simon on "Why is a 20% dropout rate bad?
• Quality of Studies: VIGOR
• Avoiding Overestimates of Benefit: Composite Endpoints in Cardiovascular Trials
• Confidence-Intervals, Power & Meaningful Clinical Benefit
• Confidence Intervals: Overlapping Confidence Intervals—A Clarification
• Primary and Secondary Outcomes: Significance Issues
• Safety Issues
  • Getting “Had” by P-values: Confidence Intervals vs P-values in Evaluating Safety Results: Low-molecular-weight Heparin (LMWH) Example
  • A Cautionary Tale of Harms versus Benefits: Misleading Findings Due to Potentially Inadequate Data Capture — Aprotinin Example
• Understanding Number Needed to Treat (NNT)
• Early Discontinuation of Clinical Trials: Oncology Medication Studies—Recent Developments and Concern
• Advanced Concepts: Can Useful Information Be Obtained From Studies With Significant Threats To Validity? A Case Study of Missing Data Points in Venous Thromboembolism (VTE) Prevention Studies & A Case Study of How Evidence from One Study Might Support Conclusions from a Flawed Study

Screening & Diagnostic Studies

• A Skeptical Look at Screening Tests
• The Bias of “Survival” in Cancer Screening Studies: CT Screening for Lung Cancer in Smokers—Back-to-Basics for Validity
• Breast and Prostate Cancer Screening—It's a Gamble, But Is It A Good One?
• Prostate Cancer Screening Interview with Otis Brawley MD, Chief Medical Officer for the American Cancer Society
• Bias in Diagnostic Studies

Secondary Studies

• Systematic Reviews: Quality & Searching Tips
• Systematic Reviews: The Need for Critical Appraisal — Antioxidents Case Study
• Systematic Reviews: Untrustable "Trustable" Sources?
  • Includes Delfini advice for working with secondary studies
• Review of Cochrane Groups’ Assessment of Bias in Studies
  • Includes our issues with the Jadad Scale
  • Includes a restatement on the Delfini approach to working with secondary studies
• Bell's Palsy Update (now with instructional slides on how to perform a conservative intention-to-treat (ITT) analysis)
  • Prior to update: Delfini Letter to BMJ: Corticosteriods are Not Proven for Treatment of Bell's Palsy
  • Prior to update: Delfini Letter to NEJM: Bell's Palsy — REDUX!
• Substandard Evidence: POEMS and Diabetes — Readers, Beware!
• Quality of Systematic Reviews: Misleading “POEM” on Hormone Therapy
• Summarizing the Strength of the Evidence: AHRQ-EHCP Grading System

Secondary Sources

• Quality of Clinical Guidelines
• Poor Quality of Guidelines: Case Study — The Evidence on Well-Child Care Recommendations
• Another Cautionary Tale About Clinical Guidelines: Screening for Heart Attack Prevention and Education (SHAPE) Task Force Guidelines Example

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