Category 10: Standards for Studies of Diagnostic Tests
Learning Objectives
Cognitive: Define diagnostic testing, list the developmental phases of a testing modality, and highlight the correct stage when comparative clinical effectiveness research (CER) should be undertaken; Describe the strengths and limitations of different diagnostic testing study designs on patient-centered outcomes, including randomized controlled trials (RCTs), observation studies, simulation or modeling, and systematic reviews; Outline accepted structures for reporting diagnostic comparative effectiveness study results, including CONsolidated Standards Of Reporting Trials (CONSORT), Standards for Reporting Diagnostic Accuracy (STARD), and Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2).
Attitudinal: Appreciate the need to address short-term, intermediate-term, and long-term patient-centered outcomes in diagnostic testing studies; Value transparency and accessibility when reporting study results to patients and stakeholders.
Skills: Design an appropriate diagnostic testing study to match the clinical context; Incorporate patient-centered outcomes in plans for evaluation of a diagnostic test; Prepare an approach for testing the influence of factors known to affect a diagnostic test under evaluation; Demonstrate application of reporting standards.
Learning Modules
This category contains the curriculum Introduction and seven main modules. Learn about the instructors for this curriculum.
- Introductory Lecture: Prepared and presented by Jodi Segal, MD, MPH
- Learning Modules: Prepared by Najlla Nassery, MD, MPH, and Jodi Segal, MD, MPH; Presented by Najlla Nassery, MD, MPH
Module 1: Introduction
Watch | Listen | Handout
Module 2: Objectives
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Module 3: Study Designs
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Module 4: Assessing the Effect of Factors Known to Affect Diagnostic Test Evaluations
Watch | Listen | Handout
Module 5: Designing Studies to Reflect Clinical Practice Pathways and Incorporating Patient-Centered Outcomes in the Evaluation of Diagnostic Tests
Watch | Listen | Handout
Module 6: Structured Reporting of Diagnostic Comparative Effectiveness Study Results
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Module 7: Communicating with Patients and Stakeholders
Watch | Listen | Handout
Category 10 Self-Assessment
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Posted: February 2016
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