Michael A. Rie

Research ethics and law of healthcare system quality improvement: the conflict of cost containment and quality.

Quality improvement (QI) activities have been done as long as medicine has been practiced and are integral to safety and efficacy of patient care. The 20th century witnessed sophisticated advances of QI methods, with concurrent advances in research ethics. The suggestion that some interventional QI activities resemble research has led to a complex conundrum, with disparate forces driving for improvement and maintenance of patient care quality vs. the societal mandate to control healthcare costs. In the middle of these conflicting priorities are QI systems charged with effecting cost-effective and efficacious healthcare processes. Given the advances in research ethics, substantially grounded in the Nuremberg Code, and the increasing resemblance of interventional QI activities to research, the concern is raised of widespread and systematic Nuremberg Code violations occurring under the guise of QI in health care. Moreover, evidence is cited to suggest that if this is the case, then such activities may be subject to litigation or prosecutorial action. The ethical and legal foundations exist to support the systematic practice of informing patients of their participation in some types of QI procedures.

Organ donation, patients' rights, and medical responsibilities at the end of life.

Objectives:The 2006 revision of the Uniform Anatomical Gift Act (UAGA) attempts to enhance the availability of organs in part by granting new authority to organ procurement organizations over patients who are near death and may be candidates for donation after death while limiting patients’ end of life (EOL) decisional authority through advance directives or surrogates. To examine the revised UAGA that may alter the ethics and law of EOL medical care in the United States. To analyze the revised UAGA in light of established legal and ethical standards. Data Sources:We evaluated the 2006 UAGA and accompanying commentary. Case law and ethics literature regarding informed consent and EOL care, state laws and regulations concerning advance directives and medical licensure, and literature concerning the fiduciary obligations of physicians were reviewed and compared with the 2006 UAGA and its 2007 amendment. Data Extraction and Synthesis:We examined the legal and medical ethics literature to evaluate the 2006 UAGA and its 2007 amendment. Conclusions:The 2006 UAGA reflects the important public policy goal of making more organs available for transplantation. However, it transfers authority over EOL decisions from patients or surrogates to organ procurement organizations, which is inconsistent with EOL U.S. common law and the ethical and legal standards that govern medicine. The extent of informed consent transferred to organ procurement organizations at the time of signing a donor registry card is legally and ethically uncertain under the UAGA. As states consider enacting the 2006 UAGA, further revisions should be considered to balance the public policy goals of increasing the availability of donated organs with truly informed and voluntary EOL decisions for patients. Further revision of the 2006 UAGA is necessary to respect patients’ civil liberties and the professional integrity of physicians who have legally and ethically recognized fiduciary duties to their dying patients.

Nontherapeutic quality improvement: The conflict of organizational ethics and societal rule of law.

Objective:Critical care ethics focuses largely on patient autonomy. Cost containment is necessary but requires rationing and limitations on a patient’s right to consume beneficial services. No laws address a process of autonomy rights limitation to consume resources in the intensive care unit. We analyzed the frictional interface between necessary cost containment as a quality improvement activity contrasted with individual autonomy in the context of the evolution of research ethics. Data Sources and Synthesis:Scholarly books, peer-reviewed articles, congressional record, legal sources, the World Wide Web, and the National Archives and Records Administration were evaluated in the context of current cost-containment–driven nontherapeutic quality improvement activities. Principal Findings:Three generations in the evolution of human research ethics are identified: 1) Hippocrates to Nuremberg Code, 2) Nuremberg to Belmont, and 3) Belmont to present. Similar ethical lapses, which place the individual at risk without disclosure for the good of future patients, have arisen recurrently in the course of history and continue presently when nontherapeutic quality improvement activities are framed as a human research activity with essentially no ethical oversight. Consequently, fiduciary obligations of professionals and their employer-institutions to their mutual patients may be at odds, creating complex layers of conflicted decision making. Nonetheless, professional Hippocratic duty to “the patient” must be congruent with the organizational ethos of limited funding “stewardship” to produce meaningful patient care. Medicine’s integrity is legally protected and mandated under the state interests (parens patria doctrine) of the common law. Conclusion:When hospitals (society and its health insurance methods) fail to ration transparently under “cost-containment ethics,” they threaten the ethical integrity of the medical profession.

Spuriously high cardiac output from injecting thermal indicator through an ensheathed port

Chez une femme de 38 ans subissant une decortication pleurale pour empyeme le debit cardiaque est faussement accru

ICU discharge bias reveals ethically troubling pay-for-performance benchmark metrics.

REFERENCES 1. Keegan MT, Gajic O, Afessa B: Severity of illness scoring systems in the intensive care unit. Crit Care Med 2011; 39:163–169 2. Pollock W, Rose L, Dennis CL: Pregnant and postpartum admissions to the intensive care unit: A systematic review. Intensive Care Med 2010; 36:1465–1474 3. el-Solh AA, Grant BJ: A comparison of severity of illness scoring systems for critically ill obstetric patients. Chest 1996; 110:1299–1304 4. Hazelgrove JF, Price C, Pappachan VJ, et al: Multicenter study of obstetric admissions to 14 intensive care units in southern England. Crit Care Med 2001; 29:770–775 5. Vasquez DN, Estenssoro E, Canales HS, et al: Clinical characteristics and outcomes of obstetric patients requiring ICU admission. Chest 2007; 131:718–724 6. Tempe A, Wadhwa L, Gupta S, et al: Prediction of mortality and morbidity by simplified acute physiology score II in obstetric intensive care unit admissions. Indian J Med Sci 2007; 61:179–185 7. Lapinsky SE, Hallett D, Collop N, et al: Evaluation of standard and modified severity of illness scores in the obstetric patient. J Crit Care 2011; 26:535.e1–535.e7 8. Lemeshow S, Teres D, Klar J, et al: Mortality Probability Models (MPM II) based on an international cohort of intensive care unit patients. JAMA 1993; 270:2478–2486 9. Higgins TL, Kramer AA, Nathanson BH, et al: Prospective validation of the intensive care unit admission Mortality Probability Model (MPM0-III). Crit Care Med 2009; 37:1619–1623 10. Nathanson BH, Higgins TL, Kramer AA, et al: Subgroup mortality probability models: Are they necessary for specialized intensive care units? Crit Care Med 2009; 37:2375–2386 11. Rojas-Suarez J, Paternin-Caicedo A, Miranda J, et al: Comparison of Severity-of-Illness Scores in Critically Ill Obstetric Patients: A 6-Year Retrospective Cohort. Crit Care Med 2014; 42:1047–1054 12. von Dadelszen P, Payne B, Li J, et al; PIERS Study Group: Prediction of adverse maternal outcomes in pre-eclampsia: Development and validation of the fullPIERS model. Lancet 2011; 377:219–227 13. Maternal Critical Care Working Group: Providing Equity of Critical and Maternity Care for the Critically Ill Pregnant or Recently Pregnant Woman. London, Royal College of Obstetricians and Gynecologists, 2011. Available at: http://www.rcog.org.uk/files/rcog-corp/Prov_Eq_ MatandCritCare.pdf. Accessed November 6, 2013 14. Carle C, Alexander P, Columb M, et al: Design and internal validation of an obstetric early warning score: Secondary analysis of the Intensive Care National Audit and Research Centre Case Mix Programme database. Anaesthesia 2013; 68:354–367 15. Canadian Research Information System: Clinical prediction models for critically ill pregnant women: MEOWS and CIPHER. Available at: http:// webapps.cihr-irsc.gc.ca/cris/detail_e?pResearchId=4339831&p_ version=CRIS&p_language=E&p_session_id=1333597. Accessed November 6, 2013

Long-term mechanical ventilation: costs, consequences, and accountability for access disparities.

1351 reperfusion after cardiac arrest in humans. Crit Care Med 2002; 30:2473–2480 12. Callaway CW, Rittenberger JC, Logue ES, et al: Hypothermia after cardiac arrest does not alter serum inflammatory mediators. Crit Care Med 2008; 36:2607–2612 13. Soares DM, Figueiredo MJ, Martins JM, et al: A crucial role for IL-6 in the CNS of rats during fever induced by the injection of live E. coli. Med Microbiol Immunol 2012; 201:47–60 14. Wernstedt I, Edgley A, Berndtsson A, et al: Reduced stressand cold-induced increase in energy expenditure in interleukin-6-deficient mice. Am J Physiol Regul Integr Comp Physiol 2006; 291:R551–R557 15. Broessner G, Lackner P, Fischer M, et al: Influence of prophylactic, endovascularly based normothermia on inflammation in patients with severe cerebrovascular disease: A prospective, randomized trial. Stroke 2010; 41:2969–2972 16. Fries M, Stoppe C, Bruckern D, et al: Influence of mild therapeutic hypothermia on the inflammatory response after successful resuscitation from cardiac arrest. J Crit Care 2009; 24:453–457