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Prepared for: The Agency for Healthcare Research and Quality (AHRQ)

Developing the Topic and Structuring Systematic Reviews of Medical Tests: Utility of PICOTS, Analytic Frameworks, Decision Trees, and Other Frameworks. Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Medical Test Reviews Methods Guide

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Prepared for: The Agency for Healthcare Research and Quality (AHRQ)

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  1. Developing the Topic and StructuringSystematic Reviews of Medical Tests: Utility of PICOTS,Analytic Frameworks, Decision Trees,and Other Frameworks Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Medical Test Reviews Methods Guide www.ahrq.gov

  2. Overview of a Medical Test Review • Analyze and Synthesize Studies • Assess Risk of Bias as a Domain of Quality • Assess Applicability • Grade the Body of Evidence • Meta-analysis of Test Performance Evidence With a “Gold Standard” — or — • Meta-analysis of Test Performance Evidence With an Imperfect Reference Standard • Decision Modeling Extract Data From Studies • Prepare Topic • Develop the Topic and Structure the Review • Choose the Important Outcomes • Search for and Select Studies for Inclusion • Search for Studies Research Sources Report Medical Test Review Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  3. Learning Objectives • Describe a guideline for developing topics and structuring systematic reviews. • Understand the importance of interacting with stakeholders in formulating topics and their reviews. • Utilize PICOTS (population, intervention, comparator, outcomes, timing, and setting) typology, frameworks, and decision trees to: • Minimize ambiguity. • Identify where resources should be focused. • Guide the presentation of results. • Recognize when it is sufficient to focus only on accuracy studies. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  4. Background • Topic development: The process by which the foundation and structure of effective systematic reviews are created. • Through this process the reviewers will: • Learn/clarify how a test might be of value in practice (e.g., specify the clinical context in which the test might be used) • Establish Key Questions to guide decisionmaking. • Structuring the review: The process by which the most direct analytic strategy is identified to account for idiosyncrasies of the data. • These are complementary processes — as the topic is developed/refined, the necessary structure of the review becomes more apparent. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  5. Challenges of Conducting Systematic Reviews of Medical Tests • An ambiguous description of the claims regarding the test that does not identify: • The target population • The specific role of the test in clinical decisionmaking • The indirect impact of medical tests requires: • Linkage of medical tests, intermediate outcomes, and improved clinical outcomes • Identification of intermediate outcomes • Limitations of the scientific literature • Direct evidence for the effect of test strategies on health outcomes (e.g., randomized controlled trial results) is rare. • Intermediate outcomes (e.g., test accuracy) are often used instead. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  6. Principles Used To Address the Challenges of Conducting a Systematic Review of Medical Tests • Use the PICOTS (population, intervention, comparator, outcomes, timing, and setting) typology to engage stakeholders. • Develop an analytic framework. • Consider using decision trees. • Sometimes it is sufficient to focus exclusively on accuracy studies. • Other frameworks may be helpful. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  7. Principle 1: Use the PICOTS Typology To Engage Stakeholders (1 of 4) Often there is a wide variety of stakeholders • U.S. Food and Drug Administration • Government funding agencies • Technical and clinical experts • Patients • Health care providers • Payers • Policymakers • Manufacturers PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  8. Principle 1: Use the PICOTS Typology To Engage Stakeholders (2 of 4) Hold a dialogue with stakeholders to understand: • The objectives of the review: • Generate Key Questions that address stakeholders’ needs. • Decisions the review is likely to affect. • The relationship of the tests to existing test strategies: • Whether used as replacement, triage, or add-on. • Range of potential clinical utility. • Potential adverse consequences of testing. PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  9. Principle 1: Use the PICOTS Typology To Engage Stakeholders (3 of 4) • Discussions with stakeholders should focus on the PICOTS typology. • Refining topics is an iterative process. • The PICOTS elements may change as the clinical context become clearer. • Reviewers should consider a plan to manage these changes. PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  10. Principle 1: Use the PICOTS Typology To Engage Stakeholders (4 of 4) Balance the need for information against the feasibility of completing the review. • Do the Key Questions reflect the needs of the stakeholders? • Is there enough time and resources to address all of these needs? • Are there existing systematic reviews or clinical guidelines that may be helpful: • In describing current strategies for the tests being reviewed? • In revealing potential benefits and harms of the tests? PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  11. Principle 2:Develop an Analytic Framework (1 of 2) Analytic framework – a graphical representation of patient care that: • Starts from the point of intervention or testing. • Leads to all important health outcomes. • Reveals potential Key Questions along the way. • Is developed in consultation with stakeholders. • Strengthens the systematic review process by: • Clarifying the link between testing, intermediate outcomes and clinical outcomes. • Clarifying Key Questions by illustrating important decisional dilemmas. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  12. Principle 2:Develop an Analytic Framework (2 of 2) Prototypical Analytic Framework 1 4 Treatment/ Other Tests Association Decision Making Testing Reduced morbidity and/ or mortality Change in Clinical Decisions Intermediate Outcome Diagnosis/ Classification of Target Condition Target Population Clinical Uncertainty 6 5 3 2 • Research Questions • Direct evidence that testing reduces • morbidity and/or mortality? • Test accuracy? • Impact of test on management? • Impact of management on health outcomes? • Impact of management on intermediate outcomes? • Impact of intermediate outcomes on health outcomes? • Adverse events, acceptability of test procedure? • Adverse events of subsequent treatment/ other tests? Other patient consequences 7 8 Adverse Events of Treatment/ Other Tests Adverse Events of Test Procedure Adapted from Harris RP, Helfand M, Woolf SH, et al. Am J Prev Med. 2001 Apr;20(3) Suppl:21-35. PMID: 11306229.

  13. Principle 3:Consider Using Decision Trees (1 of 2) • Analytic frameworks have limited ability to: • Depict multiple alternative uses of a test. • Represent potential outcome consequences of altered clinical decisions due to test results. • Decision trees can be used in conjunction with analytic frameworks to: • Illustrate the potential impact of test results on management decisions and outcomes. • Provide further clinical context of the topic. • Clarify Key Questions by: • Identifying relevant indices of diagnostic accuracy and other statistics. • Revealing which range of possible pathways and outcomes logically flow from a test strategy. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  14. Principle 3: Consider Using Decision Trees (2 of 2) A Sample Decision Tree for Breast Cancer Screening Blue Cross Blue Shield Technology Evaluation Center. Full-field digital mammography. TEC Assessment. 2002 Jul;(7).

  15. Principle 4: Sometimes It Is Sufficient ToFocus Exclusively on Accuracy Studies (1 of 4) When is it sufficient to develop Key Questions that link outcomes to diagnostic accuracy only? • Case 1: • The new test is as sensitive and specific as the old test. • The new test also has advantages over the old test, such as: • Fewer adverse effects. • Less invasive. • Easier to use. • Provides results more quickly. • Lower cost. • The downstream decisions and outcomes must be comparable between the two tests. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  16. Principle 4: Sometimes It Is Sufficient ToFocus Exclusively on Accuracy Studies (2 of 4) When is it sufficient to develop Key Questions that link outcomes to diagnostic accuracy only? • Case 2: • The new test has comparable sensitivity but greater specificity than the old test, which avoids further testing and unnecessary treatment. • The same cases must be detected by both tests. • Example: Both tests detect early stage cancer, rather than the old test detecting early stage cancer while the new test detects metastatic cancer. • The treatment efficacy must be unaffected by which test is used. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  17. Principle 4: Sometimes It Is Sufficient ToFocus Exclusively on Accuracy Studies (3 of 4) Questions to consider: • Are extra cases detected by the new, more sensitive test similarly responsive to treatment? • Are trials available that include patients selected to undergo the new test? • Do trials assess whether the new test results predict response? • If available trials selected only patients assessed with the old test, do extra cases represent the same disease spectrum or subtypes as trial participants? • Are the cases detected with the tests subsequently confirmed by the same reference standard? • Does the new test change the definition or spectrum of disease (e.g., earlier stage)? • Is there heterogeneity of test accuracy and treatment effect (i.e., do accuracy and treatment effects vary sufficiently according to the levels of a patient characteristic to change the comparison of the old and new tests)? Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  18. Principle 4: Sometimes It Is Sufficient To Focus Exclusively on Accuracy Studies (4 of 4) • Diagnostic accuracy evidence alone may be sufficient to support conclusions about a new test if the following conditions are met: • The answer to each of the questions below is “yes.” • Are extra cases detected by the new, more sensitive test similarly responsive to treatment? • Are trials available that selected patients to undergo the new test? • Do trials assess whether the new test results predict response? • If available trials selected only patients assessed with the old test, do extra cases represent the same disease spectrum or subtypes as trial participants? • Are the cases detected with the tests subsequently confirmed by the same reference standard? • The clinical utility of an older comparator test has been established. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  19. Principle 5: Other Frameworks May Be Helpful (1 of 3) • Use additional organizational frameworks to: • Categorize the Key Questions. • Identify which types of studies will address specific questions in the review. • Review cluster studies together to improve readability. • Most organizational frameworks line up with the analytical framework and PICOTS elements. PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  20. Principle 5: Other Frameworks May Be Helpful (2 of 3) • Other organizational frameworks generally classify medical test research into six different domains: • Technical efficacy • Diagnostic accuracy • Diagnostic thinking efficacy • Therapeutic efficacy • Patient outcome • Societal aspects Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  21. Principle 5: Other Frameworks May Be Helpful (3 of 3) Six Research Domains Overlaid on the PICOTS Typology and an Analytic Framework Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  22. Cases Illustrating the Five Principles • The cases are three projects that followed this process of topic development: • General topic • Initial ambiguous claim • Key concerns suggested by PICOTS, analytic frameworks, and decision trees • Refined claim • The cases represent one of three test classes: replacement, add-on, and triage. PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  23. Topic Refinement Process: General Topics • Project 1 (replacement test): Full-field digital mammography to replace screen-film mammography in breast cancer screening • Project 2 (add-on test): Human epidermal growth factor receptor 2 (HER2) gene amplification assay as add-on to HER2 protein expression assay • Project 3 (triage test): Fluorodeoxyglucose positron emission tomography as triage for breast biopsy Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  24. Sample Replacement Test Project:FFDM Versus SFM (1 of 4) • Initial ambiguous claim: Full-field digital mammography (FFDM) may be a useful alternative to single-field mammography (SFM) in screening for breast cancer. • Key concerns suggested by the PICOTS typology, an analytic framework, and a decision tree: • Key statistics: sensitivity, diagnostic yield, and recall rate • Similar types of management decisions and outcomes for index and comparator test-and-treat strategies PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  25. Sample Replacement Test Project:FFDM Versus SFM (2 of 4) Refined claim: • Interpretation, management decisions, and outcomes of the screening modalities of full-field digital mammography (FFDM) and single-field mammography (SFM) would be similar. • FFDM may have a similar recall rate and diagnostic yield at least as high as SFM. • FFDM images are more expensive but easier to manipulate and store. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  26. Sample Replacement Test Project:FFDM Versus SFM (3 of 4) Decision tree developed to investigate downstream effects: Blue Cross Blue Shield Technology Evaluation Center. Full-field digital mammography. TEC Assessment 2002 Jul;(7).

  27. Sample Replacement Test Project:FFDM Versus SFM (4 of 4) • Using the decision tree yielded these results: • The management decisions, accuracy, and downstream treatment outcomes for both full-field digital mammography (FFDM) and single-field mammography are similar. • The key test performance statistics identified were: • Sensitivity • Diagnostic yield • Recall rate • FFDM was chosen as the preferred screening modality because of the ease with which it stores and manipulates images. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  28. Sample Add-on Test Project:HER2 Gene Amplification Assay (1 of 4) • Initial ambiguous claim: Amplification and protein expression assays of the human epidermal growth factor 2 (HER2) gene may complement each other as means of selecting patients for targeted therapy. • Key concerns suggested by the PICOTS typology, an analytic framework, and a decision tree: • Key statistics: The proportion of individuals with intermediate/ equivocal HER2 protein expression results who have HER2 gene amplification. • Key outcomes: Are related to the effectiveness of HER2-targeted therapy in this subgroup. PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  29. Sample Add-on Test Project:HER2 Gene Amplification Assay (2 of 4) Refined claim: Patients with equivocal results for overexpression of human epidermal growth factor 2 (HER2) protein but positive results for amplification of the HER2 gene may benefit from HER2-targeted therapy but otherwise would have been missed. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  30. Sample Add-on Test Project:HER2 Gene Amplification Assay (3 of 4) Decision tree developed to investigate treatment outcomes: Seidenfeld J, Samson DJ, Rothenberg BM, et al. Evid Rep Technol Assess {Full Rep) 2008 Nov; (172):1-362. PMID: 19408965.

  31. Sample Add-on Test Project:HER2 Gene Amplification Assay (4 of 4) Results from using the decision tree: • Treatment outcomes are as important as test accuracy. • The key test performance statistic was identified: • The proportion of individuals with equivocal protein expression results but with positive gene assay results. • A new Key Question was identified: • Is HER2-targeted therapy (surgery and adjuvant chemotherapy with HER2-targeting agents) effective for patients with equivocal results on the protein assay but subsequently had positive amplified HER2 gene assay results? Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  32. Sample Triage Test Project:Positron Emission Tomography (1 of 4) • Initial ambiguous claim: Positron emission tomography may play an adjunctive role to breast examination and mammography in detecting breast cancer and selecting patients for biopsy. • Key concerns suggested by the PICOTS typology, an analytic framework, and a decision tree: • Key statistics: Negative predictive value • Key outcomes: Benefits of avoiding biopsy versus harms of delaying initiation of treatment for undetected tumors PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  33. Sample Triage Test Project:Positron Emission Tomography (2 of 4) Refined claim: If fluorodeoxyglucose positron emission tomography (FDG-PET) is performed before biopsy, women with negative FDG-PET results may avoid the adverse events of biopsy with potentially negligible risk of delayed treatment for an undetected tumor. Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  34. Sample Triage Test Project:Positron Emission Tomography (3 of 4) Decision tree developed to investigate several testing strategies: Samson DJ, Flamm CR, Pisano ED, et al. Acad Radiol 2002 Jul;9(7):773-83. PMID: 12139091.

  35. Sample Triage Test Project:Positron Emission Tomography (4 of 4) • Results from use of the decision tree • Key test performance statistic identified: Negative predictive value of PET • Key difference in outcomes between testing strategies identified: Harms of delaying treatment due to false negative PET vs. avoiding adverse effects of biopsy due to true negative PET • The review concluded that there is no significant benefit from using PET as triage Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  36. Key Messages • Topic development/refinement should be − • Interactive and iterative. • Aimed at understanding and clarifying the test claim. • Performed with input from stakeholders. • PICOTS typology, analytic frameworks, decision trees, and other organizational frameworks are helpful in − • Minimizing ambiguity. • Identifying where resources should be focused. • Presenting results. • In specific instances, focusing only on accuracy studies (e.g. sensitivity and specificity) is sufficient. PICOTS = population, intervention, comparator, outcomes, timing, and setting Samson D, Schoelles KM. Developing the topic and structuring systematic reviews of medical tests. In: Methods guide for medical test reviews. Available at www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  37. Practice Question 1 (1 of 2) • Understanding the clinical context of how a test will be used is important before starting a systematic review. All of the following are elements of clinical context except: • Patient characteristics • Clinical setting • Sensitivity of the test • Management options

  38. Practice Question 1 (2 of 2) Explanation for Question 1: The correct answer is c. Test sensitivity is considered an intermediate outcome, not part of clinical context. Some of the elements of clinical context include patient characteristics, how the test will fit into existing pathways, technical details of the test, and management options.

  39. Practice Question 2 (1 of 2) • What is the purpose of engaging stakeholders in topic development of a systematic review? • To understand the decisions the review is likely to affect. • To understand the range of potential clinical utility. • To understand potential adverse consequences of testing. • All of the above.

  40. Practice Question 2 (2 of 2) Explanation for Question 2: The correct answer is d. The stakeholders will be the users of the finished review. They should be engaged in discussions to understand the objectives of the review in practical terms in order to develop the review to best fit their needs.

  41. Practice Question 3 (1 of 2) • Decision trees are used to: • Outline the Key Questions for a systematic review. • Explain essential details of the test. • Show one set of possible outcomes that result from testing. • Represent the impact of test results on management decisions.

  42. Practice Question 3 (2 of 2) Explanation for Question 3: The correct answer is d. Decision trees are helpful for graphically showing the impact of test results on clinical decisions including the potential outcome consequences of altered decisions. Decision trees show the impact of test results on multiple management decisions and outcomes. A flow diagram would be a type of decision tree.

  43. Practice Question 4 (1 of 2) • It is never sufficient to focus exclusively on accuracy studies when conducting a systematic review of a medical test. • True • False

  44. Practice Question 4 (2 of 2) Explanation for Question 4: The statement is false. There are certain settings where it is sufficient to focus exclusively on accuracy studies. For example, when a new test is as sensitive and as specific as the old test and the new test has advantages such as fewer adverse effects, then diagnostic accuracy may be sufficient to assess.

  45. Authors • This presentation was prepared by Brooke Heidenfelder, Rachael Posey, Lorraine Sease, Remy Coeytaux, Gillian Sanders, and Alex Vaz, members of the Duke University Evidence-based Practice Center. • The module is based on Chapter 2, Developing the Topic and Structuring Systematic Reviews of Medical Tests: Utility of PICOTS, Analytic Frameworks, Decision Trees,and Other Frameworks. In: Methods Guide for Medical Test Reviews. AHRQ Publication No. 12-EC017. Rockville, MD: Agency for Healthcare Research and Quality; June 2012. www.effectivehealthcare.ahrq.gov/medtestsguide.cfm.

  46. References (1 of 5) • Blakeley DD, Oddone EZ, Hasselblad V, et al. Noninvasive carotid artery testing. A meta-analytic review. Ann Intern Med. 1995 Mar 1;122(5):360-7. PMID: 7847648.  • Blue Cross Blue Shield Technology Evaluation Center. Full-field digital mammography. TEC Assessment. 2002 Jul;(7). • Feussner JR, Matchar DB. When and how to study the carotid arteries. Ann Intern Med. 1988 Nov 15;109(10):805-18. PMID: 3056158.  • Harris RP, Helfand M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med. 2001 Apr;20(3 Suppl):21-35. PMID: 11306229.  • Helfand M, Balshem H. AHRQ series paper 2: principles for developing guidance: AHRQ and the effective health-care program. J Clin Epidemio.l 2010 May;63(5):484-90. PMID: 19716268.

  47. References (2 of 5) • Institute of Medicine, Division of Health Sciences Policy, Division of Health Promotion and Disease Prevention, Committee for Evaluating Medical Technologies in Clinical Use. Assessing Medical Technologies. Washington, DC: National Academy Press; 1985. Chapter 3: Methods of technology assessment. p. 80-90. • Lijmer JG, Leeflang M, Bossuyt PM. Proposals for a phased evaluation of medical tests. Med Decis Making. 2009 Sep-Oct;29(5):E13-21. PMID: 19605881. • Lord SJ, Irwig L, Bossuyt PM. Using the principles of randomized controlled trial design to guide test evaluation. Med Decis Making. 2009 Sep-Oct;29(5):E1-12. PMID: 19773580.

  48. References (3 of 5) • Matchar DB, Patwardhan M, Sarria-Santamera A, et al. Developing a Methodology for Establishing a Statement of Work for a Policy-Relevant Technical Analysis. Technical Review 11 (Prepared by the Duke Evidence-based Practice Center under Contract No. 290-02-0025). Rockville, MD: Agency for Healthcare Research and Quality; January 2006. AHRQ Publication No. 06-0026. www.ncbi.nlm.nih.gov/books/NBK44035/pdf/TOC.pdf. • Patwardhan MB, Sarria-Santamera A, Matchar DB. Improving the process of developing technical reports for health care decision makers: using the theory of constraints in the evidence-based practice centers. Int J Technol Assess Health Care. 2006 Winter;22(1):26-32. PMID: 16673677.

  49. References (4 of 5) • Samson DJ, Flamm CR, Pisano ED, et al. Should FDG PET be used to decide whether a patient with an abnormal mammogram or breast finding at physical examination should undergo biopsy? AcadRadiol. 2002 Jul;9(7):773-83. PMID: 12139091. • Sarria-Santamera A, Matchar DB, Westermann-Clark EV, et al. Evidence-based practice center network and health technology assessment in the United States: bridging the cultural gap. Int J Technol Assess Health Care. 2006 Winter;22(1):33-8. PMID: 16673678. • Seidenfeld J, Samsom DJ, Rothenberg BM, et al. HER2 testing to manage patients with breast cancer or other solid tumors. Evid Rep TechnolAssess. (Full Rep) 2008 Nov;(172):1-362. PMID: 19408965. • Van den Bruel A, Cleemput I, Aertgeerts B, et al. The evaluation of diagnostic tests: evidence on technical and diagnostic accuracy, impact on patient outcome and cost-effectiveness is needed. J ClinEpidemiol. 2007 Nov;60(11):1116-22. PMID: 17938052.

  50. References (5 of 5) • Woolf SH. An organized analytic framework for practice guideline development: using the analytic logic as a guide for reviewing evidence, developing recommendations, and explaining the rationale. In: McCormick KA, Moore SR and Siegel RA, eds. Methodology perspectives: clinical practice guideline development. Rockville, MD: Agency for Health Care Policy and Research; 1994. p. 105-13.

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