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Jornadas #PatientInHTA ·Ruth Ubago

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Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017

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Jornadas #PatientInHTA ·Ruth Ubago

  1. 1. Zaragoza, 27th-28th April 2017 Guideline for the elaboration of recommendations and appropriate use criteria in health technologies. Ruth Ubago Pérez Andalusian Agency for Health Technology Assessment (AETSA) PUBLIC HEALTH CONFERENCE 10th anniversary of the Spanish Network of Health Technology Assessment (HTA) Agencies: Insights for collaborative networking Towards Patient and public engagement in HTA
  2. 2. BACKGROUND AND CONTEXT METHODOLOGY RESULTS CONCLUSIONS TABLE OF CONTENTS
  3. 3. BACKGROUND AND CONTEXT (I) To harmonize procedures as a base for:  mutual recognition quality of work To make those procedures and methods explicit and public: assuming a compromise with transparency quality in health technology assessment (HTA )
  4. 4. BACKGROUND AND CONTEXT (II) Health Technology Assessment as a support to the Decision Making Process: from EVIDENCE to RECOMENDATIONS. MAIN STEPS EVIDENCE SYNTHESIS: Formulate question Summary of findings: efficacy/safety RECOMMENDATION/DECISION
  5. 5. Sintetizar los principios, procedimientos y metodología de la elaboración de IRE en el contexto de la Red BACKGROUND AND CONTEXT (III) Guideline for the elaboration and adaptation of rapid health technology assessment reports. April, 2016. Objectives: To update methods and processes. To harmonize procedures. EVIDENCE SYNTHESIS
  6. 6. Sintetizar los principios, procedimientos y metodología de la elaboración de IRE en el contexto de la Red BACKGROUND AND CONTEXT (IV) Decision about: What to do? What to cover? Should this technology/device be covered? Should we stop doing a screening for a cancer in asymptomatic men? In all men? RECOMMENDATION/DECISION
  7. 7. BACKGROUND AND CONTEXT (V) MAKING RECOMMENDATIONS/DECISION KEY POINTS STAKEHOLDER INVOLVEMENT: policy makers, clinicians, scientific societies and patients. EXPLICIT AND TRANSPARENT PROCCES TO FORMULATE A RECOMMENDATION/DECISION.
  8. 8. METHODOLOGY  COORDINATION GROUP: Avalia-t and AETSA. WORKING GROUP: UETS- ISCIII, Osteba, AQuAS, SCETS, IACS, UETS Madrid.
  9. 9. 1. RECOMMENDATIONS 2. APPROPRIATE USE CRITERIA 3. RECOMMENDATIONS FOR FUTURE RESEARCH RESULTS
  10. 10. 1. RECOMMENDATIONS GRADING OF RECOMMENDATIONS, ASSESSMENT, DEVELOPMENT AND EVALUATION (GRADE) CRITERIAR PURPOSE: To inform decisions in the context of: Clinical recommendations Coverage decisions Health system recommendations
  11. 11. WELL ESTABLISHED METHOD GRADE methodology. Practical experiences of application of GRADE at various contexts: World Health Organization, HTA Agencies, Scientific societies, Cochrane Collaboration. 1. RECOMMENDATIONS DELIVERABLES SPANISH HTA REPORTS WITH GRADE RECOMMENDATIONS GRADING OF RECOMMENDATIONS, ASSESSMENT, DEVELOPMENT AND EVALUATION (GRADE) CRITERIAR
  12. 12. MAIN STEPS: PICO question: Setting perspective, Subgroups, Background. Assessment of evidence (GRADE methodology) and judgements. DECIDE project. Evidence to Decision (EtD) framework. 1. RECOMMENDATIONS GRADING OF RECOMMENDATIONS, ASSESSMENT, DEVELOPMENT AND EVALUATION (GRADE) CRITERIAR
  13. 13. DRAWING CONCLUSIONS/RECOMMENDATIONS COVERAGE DECISIONS: -Technology not covered. -Covered only in the context of research. -Restricted coverage. -Full coverage. Direction and strength Justification Subgroups Implementation Monitoring and evaluation Research priorities 1. RECOMMENDATIONS GRADE CRITERIAR
  14. 14. •PANEL COMPOSITION IS A CRUCIAL STEP: Patients, Policy makers, Clinicians, Scientific societies, Methodologists. •ADVANTAGES: Consistent and transparent method. How much outcomes are valued by all the stakeholders is explicitely considered. •POTENTIAL LIMITATION: EtD frameworks are complex. Additional resources needed. 1. RECOMMENDATIONS GRADE CRITERIAR KEY ISSUES
  15. 15. 1. RECOMMENDATIONS 2. APPROPRIATE USE CRITERIA. 3. RECOMMENDATIONS FOR FUTURE RESEARCH. RESULTS
  16. 16. 2. APPROPRIATE USE CRITERIA PURPOSE: To assess the “appropriateness” of medical procedures or services. THE RAND/UCLA APPROPRIATENESS METHOD
  17. 17. 2. APPROPRIATE USE CRITERIA DELIVERABLES SPANISH HTA REPORTS WITH APPROPRIATENESS CRITERIA
  18. 18. THE RAND/UCLA APPROPRIATENESS METHOD 2. APPROPRIATE USE CRITERIA WHEN TO BE USED When scientific evidence is not available or we cannot provide in depth evidence sufficient to be applied to the wide range of patients seen in everyday clinical practice.
  19. 19. Synthesis of the evidence List of Indications/Clinical Scenarios and Definitions Criteria: Appropriate, Uncertain, Inappropriate Expert Panel rates indications in Two Rounds MAIN STEPS 2. APPROPRIATE USE CRITERIA THE RAND/UCLA APPROPRIATENESS METHOD Core Panel
  20. 20. KEY ISSUES ADVANTAGES: 1. Synthesis of published literature prior to consensus techniques incorporated. 2. It allows for both confidential ratings and group discussion. 3. Multidisciplinary panel encourages consensus from a wider group. POTENTIAL LIMITATIONS: 1. Takes great deal of time from gathering of the evidence to multiple rounds of consensus. 2. Misclassification is expected. 3. It lacks a clear rating of the evidence. 2. APPROPRIATE USE CRITERIA THE RAND/UCLA APPROPRIATENESS METHOD
  21. 21. 1. RECOMMENDATIONS 2. APPROPRIATE USE CRITERIA. 3. RECOMMENDATIONS FOR FUTURE RESEARCH. RESULTS
  22. 22. 3. RESEARCH RECOMMENDATIONS PURPOSE: To inform about primary biomedical research after finding evidence gaps in the published literature.
  23. 23. 3. RESEARCH RECOMMENDATIONS EUnetHTA framework Joint Action 2 Work package 7
  24. 24. WHEN TO BE USED When finding EVIDENCE GAPS after developing HTA report. “Missing evidence from a body of research that would potentially answer the questions of decision makers. So final decision cannot be made until these gaps are covered”. 3. RESEARCH RECOMMENDATIONS FOR BIOMEDICAL PRIMARY RESEARCH ADDITIONAL OBSERVATIONAL REAL WORLD DATA AFTER COVERAGE FOR REINFORMING DECISION MAKING
  25. 25.  We have updated our methods and processes for developing recommendations and appropriate use criteria, as well as harmonizing all these procedures. CONCLUSIONS
  26. 26. Zaragoza, 27th-28th April 2017 Thank you very much PUBLIC HEALTH CONFERENCE 10th anniversary of the Spanish Network of Health Technology Assessment (HTA) Agencies: Insights for collaborative networking Towards Patient and public engagement in HTA Follow us in @AETSA_ www.aetsa.org

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