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Oral presentation ICC-PBM 2018 @ G-I-N conference Manchester (UK) 2018

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Oral presentation ICC-PBM 2018 @ G-I-N conference Manchester (UK) 2018

  1. 1. HOW CAN WE INTEGRATE GRADE AND A FORMAL CONSENSUS METHOD INTO AN INTERNATIONAL GUIDELINE PROJECT? THE EXAMPLE OF AN INTERNATIONAL CONSENSUS CONFERENCE ON PATIENT BLOOD MANAGEMENT (ICC-PBM) HANS VAN REMOORTEL COORDINATING RESEARCHER CENTRE FOR EVIDENCE-BASED PRACTICE (CEBAP) BELGIAN RED CROSS WWW.CEBAP.ORG
  2. 2. Conflicts of interests  Employee of Belgian Red Cross-Flanders, providing safe blood products to hospitals in Flanders and Brussels which did not influence his contribution to ICC-PBM 2018 Frankfurt  No conflicts of interest to declare
  3. 3. Outline 1.Patient Blood Management: 3 topics of interest and 17 PICO questions 2. Using a formal consensus methodology: the Consensus Development Conference 3. Using an evidence-based methodology: the GRADE approach
  4. 4. Patient blood management (PBM) is a patient- focused, evidence-based and systematic approach to optimize the management of patient and transfusion of blood products for quality and effective patient care.
  5. 5. Goodnough 2012
  6. 6. Scientific Committee: formulating 3 topics of interest and 17 PICO questions Scientific Committee Pierre Albaladejo (Grenoble University Hospital, France/ISTH) Shubha Allard (NHS Blood & Transplant/ISBT) Cécile Aubron (Academic Hospital of Brest, France/SFTS) Kari Aranko (European Blood Alliance/EBA) Dana Devine (Canadian Blood Services/CBS) Craig French (Western Health, Melbourne Australia) Kathrine P. Frey (Fairview Health Services and Patient Readiness Institute, Minneapolis MN/AABB) Christian Gabriel (Ludwig Boltzmann Institute for clinical and experimental traumatology, Austria/DGTI) Richard Gammon (One Blood, Orlando/AABB) Andreas Greinacher (Institut für Immunologie und Transfusionsmedizin Greifswald/ICTMG) Marian van Kraaij (Sanquin, the Netherlands/EBA) Jerrold Levy (Duke University School of Medicine, North Carolina/ISTH) Giancarlo Liumbruno (Italian National Institute of Health/EBA) Patrick Meybohm (University Clinics of the Johann Wolfgang Goethe University Frankfurt/Main) Markus Müller (Institute for Transfusion Medicine and Immunohaematology Frankfurt/EBA) Mike Murphy (NHS Blood & Transplant and AABB/EBA) Hans Van Remoortel (Centre for Evidence-Based Practice, Belgian Red Cross) Ben Saxon (Australian Red Cross Blood Service/ARCBS) Erhard Seifried (German Red Cross Blood Transfusion Services/EBA) (chair) Nadine Shehata (Mount Sinai Hospital Toronto/ICTMG) Pierre Tiberghien (French National Blood Service/EBA) Claudio Velati (Società Italiana di Medicina Trasfusionale e Immunoematologia) Erica Wood (Epidemiology and Preventive Medicine at Monash University/ISBT) Face-to-face meeting SciCom February 2017
  7. 7. Topic 1: Preoperative anaemia  Definition and diagnosis (PICO 1 and PICO 2)  Treatment (PICO 3) Topic 2: RBC transfusion triggers  Intensive care and acute interventions (PICO 4-9 & PICO 14)  Haematology and oncology (PICO 10 & PICO 11)  Neurology (PICO 12 & PICO 13) Topic 3: PBM implementation  Effectiveness implementation of ‘comprehensive’ PBM programs (PICO 15)  Effectiveness behavioural interventions (PICO 16)  Effectiveness decision support systems (PICO 17) Face-to-face meeting SciCom February 2017 Scientific Committee: formulating 3 topics of interest and 17 PICO questions Scientific Committee
  8. 8. Outline 1. Patient Blood Management: 3 topics of interest and 17 PICO questions 2.Using a formal consensus methodology: the Consensus Development Conference 3. Using an evidence-based methodology: the GRADE approach
  9. 9. 2-day International Consensus Conference on Patient Blood Management (24 & 25 April, Frankfurt, Germany) - 200 medical experts - From 5 continents - Representing more than 10 disciplines (e.g. transfusion medicine, surgery, anesthesiology and haematology) - Co-sponsors: AABB, ISBT, DGTI, SFTS, SIMTI, EBA - Participation: ARCBS, TBS, ICTMG, ISTH, NBA, ÖGBT, SFAR - Presence: WHO, EU Commission, DGAI, National Health Authority Australia
  10. 10. Scientific Committee Decision- making panelists Speakers (Co-)chairs Audience Rapporteurs Consensus Development Conference (CDC)
  11. 11. Consensus Development Conference (CDC) *Nair R et al., Semin Arthritis Rheum, 2011; Sher G and Devine D, Transfusion, 2007 Major steps in the Consensus Development Conference format? 1) Evidence presented by the SCIENTIFIC COMMITTEE to the conference, CHAIRED in a public (open) session followed by discussion (AUDIENCE) 2) Private (executive) session by DECISION-MAKING panel to further deliberate on the evidence and discussion to reach consensus -> result: draft consensus statement. 3) Presentation of draft consensus statement in a plenary session + review/comment/indicative voting by conference attendees. 4) Final executive session with final consensus statement by DECISION- MAKING PANEL.
  12. 12. Outline 1. Patient Blood Management: 3 topics of interest and 17 PICO questions 2. Using a formal consensus methodology: the Consensus Development Conference 3.Using an evidence-based methodology: the GRADE approach
  13. 13. GRADE approach From evidence to recommendations – transparent and sensible P I C O Outcome Outcome Outcome Outcome Critical Critical Important Not High Moderate Low Very low GradedownGradeup 1. Risk of bias 2. Inconsistency 3. Indirectness 4. Imprecision 5. Publication bias 1. Large effect 2. Dose response 3. Confounders Summary of findings & estimate of effect for each outcome Systematic review Randomization Experimental: High Observational: Low Scientific Committee
  14. 14. GRADE overall quality of the evidence across outcomes based on lowest quality of critical outcomes Guideline development GRADE recommendations Evidence to recommendation • For or against (direction) ↑↓ • Strong or conditional/weak (strength) By considering balance of consequences (evidence to recommendation)  Quality of evidence  Balance benefits/harms  Values and preferences  Resource use (cost(-effectiveness)  Equity – Acceptability - Feasibility • “We recommend using…” • “We recommend against using…” • “We suggest using…” • “We suggest against using…” EtD framework GRADEpro Guideline Formulate recommendations Transparency, clear, actionable Research? Decision-making panelists Audience Rapporteurs (Co-)chairs Panelists GRADE approach From evidence to recommendations – transparent and sensible
  15. 15. CRITERIA JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS 1. DESIRABLE EFFECTS How substantial are the desirable anticipated effects? 2. UNDESIRABLE EFFECTS How substantial are the undesirable anticipated effects? 3. CERTAINTY OF EVIDENCE What is the overall quality of the evidence of effects? 4. VALUES Is there important uncertainty about or variability in how much people value the critical outcomes? 5. BALANCE OF EFFECTS Does the balance between desirable and undesirable effects favor the intervention or the comparison? 6. RESOURCES REQUIRED How large are the resource requirements (costs)? 7. COST EFFECTIVENESS Does the cost-effectiveness of the intervention favor the intervention or the comparison? 8. EQUITY What would be the impact on health equity? 9. ACCEPTABILITY Is the intervention acceptable to key stakeholders? 10. FEASIBILITY Is the intervention feasible to implement? Evidence-to-Decision framework Rapporteurs Rapporteurs Rapporteurs Rapporteurs Rapporteurs Rapporteurs Rapporteurs Rapporteurs Rapporteurs Rapporteurs Audience Audience Audience Audience Audience Audience Audience Audience Audience Audience
  16. 16. Outline 1. Patient Blood Management: 3 topics of interest and 17 PICO questions 2.Using a formal consensus methodology: the Consensus Development Conference 3.Using an evidence-based methodology: the GRADE approach +
  17. 17. 1 year of preparation • Feb 2017: SciCom meeting, Frankfurt (Germany) • June 2017: Sponsors meeting, ISBT Copenhagen (Denmark) • March 2017 – April 2018: 12 SciCom teleconferences • Jan/Feb 2018: two face-to-face meetings with SciSec and chairs, Frankfurt (Germany) • March 2017 – January 2018: systematic reviews 17 PICO questions (+/- 18.000 references screened, 145 studies included) • Dec 2017 – April 2018: • 2 SciCom webinars • 4 panellists webinars • 3 chairs webinars • 1 webinar rapporteurs • 1 tutorial rapporteurs • 2 speakers webinars
  18. 18. Start day 1 (24 April 2018)
  19. 19. 3 Parallel sessions Session 1: Preoperative anaemia  Definition and diagnosis (PICO 1 and PICO 2)  Treatment (PICO 3) Session 2: RBC transfusion triggers  Intensive care and acute interventions (PICO 4-9 & PICO 14)  Haematology and oncology (PICO 10 & PICO 11)  Neurology (PICO 12 & PICO 13) Session 3: PBM implementation  Effectiveness implementation of ‘comprehensive’ PBM programs (PICO 15)  Effectiveness behavioural interventions (PICO 16)  Effectiveness decision support systems (PICO 17) Day 1 (24 April 2018) Part 1: Plenary • Evidence presented by • Based on Evidence-to-Decision (EtD) framework • Discussion with moderated by • Notes recorded by AudienceRapporteurs (Co-)chairs Panelists Speakers
  20. 20. Day 1: 3 parallel/open sessions
  21. 21. Day 1: 3 parallel/open sessions
  22. 22. 3 Parallel sessions Session 1: Preoperative anaemia  Definition and diagnosis (PICO 1 and PICO 2)  Treatment (PICO 3) Session 2: RBC transfusion triggers  Intensive care and acute interventions (PICO 4-9 & PICO 14)  Haematology and oncology (PICO 10 & PICO 11)  Neurology (PICO 12 & PICO 13) Session 3: PBM implementation  Effectiveness implementation of ‘comprehensive’ PBM programs (PICO 15)  Effectiveness behavioural interventions (PICO 16)  Effectiveness decision support systems (PICO 17) Day 1 (24 April 2018) + + + Part 1: Plenary Part 2: Closed (private/executive session) • Evidence presented by • Based on Evidence-to-Decision (EtD) framework • Discussion with moderated by • Notes recorded by • Based on EtD framework • Draft recommendations by • Moderated by • Notes recorded by AudienceRapporteurs (Co-)chairs Panelists Speakers
  23. 23. Day 1: closed session with decision-making panels
  24. 24. Draft conclusions at the end of day 1 TYPE OF RECOMMENDATION Strong recommendation against the intervention Conditional recommendation against the intervention Conditional recommendation for either the intervention or the comparison Conditional recommendation for the intervention Strong recommendation for the intervention RECOMMENDATION Option 1: Formulation of a strong or conditional recommendation Terminology strong recommendation: “we recommend…” – “clinicians should…” – “clinicians shoud not….” – “Do….” – “Don’t…..” Terminology weak/conditional recommendation: “we suggest…” – “clinicians might….” – “we conditionally recommend…” Option 2: No recommendation Option 3: Research recommendation JUSTIFICATION … SUBGROUP CONSIDERATIONS … IMPLEMENTATION CONSIDERATIONS … MONITORING AND EVALUATION … RESEARCH PRIORITIES … Closed session with chairs/decision-making panels/rapporteurs
  25. 25.  Plenary session with the general audience (all 3 topics)  Presentation draft recommendations/justifications by AudienceRapporteurs (Co-)chairs Panelists Day 2 (25 April 2018)
  26. 26.  Plenary session with the general audience (all 3 topics)  Presentation draft recommendations/justifications by  Discussion with/indicative voting by , moderated by the  Notes recorded by AudienceRapporteurs (Co-)chairs Panelists Day 2 (25 April 2018)
  27. 27.  Plenary session with the general audience (all 3 topics)  Presentation draft recommendations/justifications by  Discussion with/indicative voting by , moderated by the  Notes recorded by  Closed sessions with the decision-making panelists and (co-) chairs  Formulation of final recommendations by , moderated by the AudienceRapporteurs (Co-)chairs Panelists Day 2 (25 April 2018)
  28. 28. Day 2: closed session with decision-making panels
  29. 29. Conclusions: 10 evidence-based recommendations  Topic 1: Preoperative anaemia  4 recommendations (1 strong, 3 conditional)  Topic 2: RBC transfusion triggers  4 recommendations (2 strong, 2 conditional)  Topic 3: PBM implementation  2 recommendations (2 conditional)  Research recommendations for all topics
  30. 30. Lessons learned to improve a future guideline project  Preparation: time versus resources  2 face-to-face meetings between methodologists and experts  Beginning: PICO + selection criteria (lumping vs splitting!)  Intermediate: to discuss results systematic review  Improve sense of ownership and knowledge of evidence-based methodology by different groups (panel members, chairs)  More rigorous process to select panel members (COI!) and formal/blind voting system on draft/final recommendations  Organization Consensus conference immediately before/after blood transfusion conference (e.g. ISBT) could increase participation (by general audience).
  31. 31. Acknowledgments Prof. Dr. Erhard Seifried (German Red Cross Blood Transfusion Services/EBA) (chair) Dr. Kari Aranko (European Blood Alliance/EBA) Willemijn Kramer (European Blood Alliance/EBA) Dr. Markus Müller (Institute for Transfusion Medicine and Immunohaematology Frankfurt/EBA) Prof. Dr. Patrick Meybohm (University Clinics of the Johann Wolfgang Goethe University Frankfurt/Main) Chairs of the Plenary Sessions: Prof. Dr. Reinhard Burger, Robert-Koch-Institute, Berlin, Germany Prof. Dr. Klaus Cichutek, Paul-Ehrlich-Institute, Langen, Germany Prof. Dr. Jimmy Volmink, Faculty of Medicine and Health Sciences at Stellenbosch University, South Africa Decision-making panel ‘Preoperative anaemia’ Prof. Dr. Yves Ozier, University Hospital of Brest, France (Chair) Prof Dr. Emmy De Buck, Centre for Evidence Based Practice, Belgian Red Cross-Flanders, Belgium (Co-Chair) Decision-making panel ‘RBC transfusion triggers’ Prof. Dr. Reinhard Burger, Robert-Koch-Institute, Berlin, Germany (Chair) Prof. Dr. Jimmy Volmink, Faculty of Medicine and Health Sciences at Stellenbosch University, South Africa (Co-Chair) Decision-making panel ‘PBM implementation’ Prof. Dr. Jonathan Waters, Magee-Womens Hospital of the University of Pittsburgh Medical Center (Chair) Prof. Dr. Dean Fergusson, Ottawa Hospital Research Institute, University of Ottawa, Canada (Co-Chair) Stefan Holtzem (Photographer)
  32. 32. Acknowledgments Centre for Evidence-Based Practice (CEBaP) Belgian Red Cross www.cebap.org @CEBaP_evidence

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