Daniel Strech, MD, PhD (Hannover Medical School, Germany)

1. The role of ethics committees and ethics consultation in priority setting.An evidence-based analysis Daniel Strech, MD, PhD (Hannover Medical School, Germany) Samia Hurst, MD (University of Geneva, Switzerland) Marion Danis, MD (National Institutes of Health, USA) Priorities 2010 Boston, April 2010

2. Definitions • Rationing • Withholding of a medical technique that has net additional benefit for the patient for reasons of cost • Rationalization • aims to reduce excessive or faulty treatment and inefficiency without reducing net additional benefit

3. Presuppositions • Rationing is in fact unavoidable in clinics • Often rationing is implicitly and thus non-transparently • Bedside decisions are limited by budgets and prospective compensation (DRGs) • Affects quality but also fairness of medical care.

4. Current state of research • Normative frameworks1-3 • ethically appropriate implementation of unavoidable rationing • Qualitative research • Conflicts that arise when doctors make decisions under implicit limits • Synthesis (objective of this presentation) • Specifying the role of ethics consultation and ethics committees in allocation decisions at the hospital level • Emanuel EJ (2000) Justice and managed care. Hastings Cent Rep • Daniels N and Sabin JE (2002) Setting limits fairly OUP • Hurst SA and Danis M (2007) A framework for rationing by clinical judgment. Kennedy Inst Ethics J.

5. The (indirect) need for ethics consultation in rationing questions • Data on bedside rationing1-3 • Italy, Great Britain, Norway, Switzerland: 56 % of doctors reported rationing clinical interventions1 • Logical argument: no health care system can provide all patients with all possibly beneficial treatments4,5 • Hurst SA et al. (2006) Prevalence and Determinants of Physician Bedside Rationing J Gen Intern Med • Ward NS et al. (2008) Perceptions of cost constraints, resource limitations, and rationing in United States intensive care units Crit Care Med • Strech D et al. (2009) [Extent and impact of bedside rationing in German hospitals: results of a representative survey among physicians]. Dtsch Med Wochenschr • Kent D (2010) Just-as-good Medicine American Scientist • Shrank WH et al (2006) Physicians' perceptions of relevant prescription drug costs Am J Manag Care

6. The (indirect) need for ethics consultation in rationing questions • Doctors’ rationing decisions are inevitabley a function of the particularities of individual cases • patient characteristics and clinical context • “those that shout the loudest get the most”1 • Leeway in interpretation of „hard“ criteria such as medical benefit or cost-effectiveness2 • Non-patient factors that play a role • clinic’s general financial situation • the pressure of competition • Berney L et al. (2005) Ethical principles and the rationing of health care Br J Gen Pract • Strech D et al. (2009) [Challenges of explicit rationing by cost-conscious guidelines] Gesundheitsökon. & Qualitätssich.

7. Study of direct need: Should ethics consultants help clinicians face scarcity in their practice1 • Types of support • professional reassurance that the decision was correct (48%) • someone capable of providing specific advice (41%) • help in weighing outcomes (36%) • clarification of the issues (36%) • help in talking things through with the patient (33%) • mediation of conflict (33%) • Hurst, S.A., et al. (2008) Should ethics consultants help clinicians face scarcity in their practice? J Med Ethics

8. Four-stage approach for ethics consultation in rationing questions1 • Training • Identifying actual scarcity-related problems at clinics • Supporting decision-making • Evaluation • Strech D, Hurst M, Danis M [accepted for publication] The role of ethics committees and ethics consultation in priority setting. Medical Care.

9. Didactic and practical goals • Didactic goals • foster understanding of the theories of justice and their continued application-based development • Practical goals • encourage an awareness and understanding • encourage rationalization before rationing • reinforce consistency • facilitate explicit reflection and justification • improve transparency • prevent the misuse of consulting structures

10. 1. Training • Essential reasons for scarcity of means • Physician’s responsibility and patient trust • focus on the possibility that rationing, when carried out fairly under scarcity conditions, can be in the best interest of patients (regarded from an inter-personal, public health standpoint) • Rationing versus rationalizing • clarification (discussion) of whether certain actions are to be considered rationing or rationalization • Justice • clarify the fact that the application of alternative theories of justice or methods of economic analysis could lead to different results in rationing decisions • Prioritization criteria • broad consensus: extent of the benefit, cost-effectiveness, severity availability of an alternative intervention • Controversial: Patient age, “rule of rescue”

11. Material and procedural conditions of a just allocation

12. 2. Identification of resource constraints in the clinical setting • Awareness and understanding of the constraints of the specific clinical environment • Survey among the clinic personnel • not limited to health care providers • identify the spectrum of actual problems • Identify clinic employees’ expectations towards ethics consultation. • provide an initial orientation concerning the distribution of problems among the individual departments. • Examining the relevant contextual variables • routine processes, informal agreements, guidelines for rationing decisions, etc.

13. Material and procedural conditions of a just allocation

14. Support in decision-making processes • Classical functions of ethics consultation • Facilitation of discussion • joint appraisal of relevant information • work out the available alternatives • Alleviate psychic burdens of rationing? • Responsibility for consultants of explicitly introducing well-justified criteria for rationing? • Draw attention to circumstances when ethically problematic rationing criteria are being used? • Should ethics consultants intervene in decision-making?

15. Material and procedural conditions of a just allocation

16. Evaluation • Subjective satisfaction with the consultation by those who request consultative advice • Objective (results and process) evaluation through documentation • basic question and processes that determined the question • information taken into consideration and its interpretation • principles and normative criteria taken into account • Final decision and compromises • Assessment of evaluation results includes (among other things) the comparison with similar cases and thus a review of decision-making consistency

17. Material and procedural conditions of a just allocation

18. Conclusion • Legitimate ethics consultation needs to be embedded into a broader framework addressing material and procedural conditions of just allocation • Need for further translational research • E.g. different implementation strategies • Readiness of clinical managers1 • to utilize ethics frameworks • to involve stakeholders • Resource allocation happens at multiple levels (community, institution) • organizational ethics committees. • Foglia MB et al. (2009) Ethical challenges within Veterans Administration healthcare facilities Am J Bioeth

19. The role of ethics committees and ethics consultation in priority setting.An evidence-based analysis Daniel Strech, MD, PhD (Hannover Medical School, Germany) Samia Hurst, MD (University of Geneva, Switzerland) Marion Danis, MD (National Institutes of Health, USA) Priorities 2010 Boston, April 2010