Quality
of Life Research,
1, pp. 273-276
Commentary
Quality of life research evidence
Department of Public Health, Cornell New York, NY 10021, USA.
University
and the ethics of
Medical
College,
In a recent article published in this journal, Till et al. discuss the role of preference assessments in quality of life (QOL) research in oncology.’ They suggest that such preference evaluations are a special case of a more general issue: the need to develop an ‘ethics of evidence’, meaning standards for the creation, assessment, and communication of evidence. They are referrin here to a proposal made by me a few years ago, 3 j3 and I welcome this opportunity to comment on their work and to further elucidate the concept. The authors present a context within which such an ethics of evidence could be developed-an adaptation of the ‘measurement iterative loop’ proposed by Tugwell et al. 4 as a framework for the critical appraisal of need, benefits, and costs of health interventions. This model represents the process of identification of a problem, development and evaluation of interventions, and reassessment of the problem, subdivided into a logical progression of seven stages each of which involves the use of scientific evidence. Till et al.’ make the point that QOL data have thus far received little attention in decision making in oncology, and that research is needed pertaining to the transfer of QOL information to both clinical practice and decisions about health policy. They suggest that in the case of new treatments affecting QOL there is a role for so-called preference studies and preference trials, and, using the above-mentioned multicomponent model for the ethics of evidence, they identify areas where such studies would be appropriate sources of evidence. The guiding principle throughout is that of informed, shared decision making.
Research Foundation
supported by and the Esther
@ 1992 Rapid Communications
funds from A. and Joseph
of Oxford
Ltd
the National Klingenstein
Science Fund.
1300 York Avenue,
These developments are very much along the lines I had envisioned in proposing the concept. A number of years ago, having observed at close hand the emergence of the new field of bioethics, I reached the conclusion that a special term was needed to focus on ethical aspects of uncertainty and statistical evidence in medicine. Participating in bioethics seminars and conferences addressing a wide range of issues, over and over again I was surprised to note that consideration of relevant quantitative aspects of the situation would be conspicuously absent from the discourse. Scholars in bioethics tend to come from the fields of philosophy, law or medicine, and many are not familiar with concepts and methods of statistical inference. This may be one of the reasons that the general question of scientific validity, including the poor quality of much clinical research and the lack of proper assessment of many medical procedures, has been all but ignored in the bioethics literature. This lack of awareness of the extent of uncertainty and of the fact that so much more could have been done by properly designed and implemented studies to clarify or even resolve a given problem, engenders a special pitfall: it may inadvertently keep some from seeing when ideology takes the place of evidence. Transmission to the secondary level, reporting by the mass media, only exacerbates the situation. One case in point was the highly publicised controversy involving Baby Jane Doe, the infant born in 1983 with spina bifida, an incomplete fusion of the spinal column.2 The issue at hand was the role of the US Government in protecting children with severe handicaps. Two surgical procedures are generally required for this disorder: closing the opening in the infant’s back to prevent infection, and placing a shunt to prevent brain damage from a build-up of fluid on the brain, Quality
of Life Research . Vol I .1992
273
V. Mike caused by an associated malformation of the brain stem. The baby was said to be suffering also from microcephaly - abnormally small head size-and thus destined for severe mental retardation in addition to her physical impairments. This was widely reported by the media in support of her parents’ decision to refuse treatment. The many uncertainties surrounding prognosis for spina bifida and the official testimony of two neurosurgeons that Baby Jane’s head size was consistent with normal intelligence were ignored in most discussions of the case and were not reported by the major news media.2 In early 1985 a neonatologist colleague visited the hospital in New York where Baby Jane had resided, to review her medical record. At that time her chart contained not one, but two records of her head size at birth, one showing normal and the other a borderline circumference. There was no indication of microcephaly. Convinced of the need to study and elucidate the role of evidence as an integral part of the ethics of modern medicine, I sought a term that would help call attention to the issues. Before deciding, I consulted a specialist in the bibliographies of the philosophy of science and technology and of applied ethics, who assured me that the concept of ‘ethics of evidence’ did not as yet exist in the literature. I used it for the first time in 1987, in a lecture that was published in 1989.2 The ethics of evidence, meaning-in concise but not exhaustive terms-standards for the creation, assessment, and communication of evidence, is proposed as an approach to medical uncertainty to be incorporated into the evolving scope of biomedical ethics. Its main tenet is two-fold: (1) there is a need to develop and disseminate the best possible scientific evidence as a basis for every phase of medical decision making, and (2) there is a need to increase awareness of, and come to terms with, the ultimately irreducible nature of uncertainty. This in turn implies the need to study and further clarify the complementary relationship of the concepts of evidence and uncertainty, in terms that are meaningful to nonspecialists. The ethics of evidence addresses the full spectrum of the health care process: biomedical research, clinical practice, administration, and health policy; it is meant to apply to all relevant professional groups, including the news media, as well as the general public. Such an ethics of evidence is strongly supported by the three basic principles of contemporary biomedical ethics, the principles of respect for persons, beneficence, and justice. Consonant with 274
Quality
of Life Research
. Vol 1 . 1992
the major traditions of Western thought, these principles were identified in the 1978 Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 5 Respect for persons, or autonomy, with its derivative concept of informed consent, has been the guiding theme of much of American bioethics discourse. This principle gives patients the right to make their own decisions about medical treatment. But no one can give a truly ‘informed consent to a procedure that has not been properly evaluated, since the information is just not available. The patient is frequently not even aware of the extent of medical uncertainty. The principle of beneficence and nonmaleficence - help or at least do no harm-dates back to Hippocrates and is directly relevant to an ethics of evidence. It is unethical to use powerful diagnostic and therapeutic procedures without sound assessment of their safety and effectiveness. From this it readily follows that clinical studies without proper statistical design are in turn unethical. These are, incidentally, not new insights. Quality of the proposed research was already addressed in Rule 2 of the 1947 Code of Nuremberg: “The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods of study, and not random and unnecessary in nature”. 6 The principle of justice, taken beyond the fair selection of research subjects, can be interpreted to mean equity of access to health care. It supports the ethics of evidence in an indirect, but very special way. If only scientifically validated procedures were reimbursed by third-party payers (government plans and private insurance carriers), the resulting savings could provide medical coverage for the many millions of Americans now without adequate health insurance. Seeking safe and effective procedures-the approach mandated by the ethics of evidence-would at the same time yield better health care for everyone. It is interesting to note that there is a document supporting the ethics of evidence predating the Code of Nuremberg. Legally binding regulations pertaining to new therapies and experimentation on humans, more stringent than the subsequent Nuremberg Code, were issued in Germany in 1931 and remained in effect throughout the Nazi period. The ethics of research and treatment, the quality of the research, informed consent, and professional responsibility were discussed explicitly and in detail. 7
Ethics of ezdence The ethics of evidence is thus not being proposed as something radically new, a new code of ethics, but primarily as a means of consciousness raising and a focus of discourse for all. The need for attention to these matters is urgent. The need and timeliness for an integrated program of medical technology assessment in the United States has been stated repeatedly, perhaps never more eloquently than was done by Paul Ellwood.* Ellwood seeks the establishment of a national program of ‘outcomes management’ or, in other words, a ‘technology of patient experience.’ This program would provide a permanent national medical data base linking medical interventions with health outcomes. As he sees it, “the fine line between chaos and democracy is rationality of choice”, and “the health care system has become an organism guided by misguided choices; it is unstable, confused, and desperately in need of a central nervous system that can help it cope with the complexities of modern medicine”. The notion of a central nervous system is a powerful metaphor. But it is one that requires careful analysis; a reductionist approach will not resolve the problem. The key functions in this structure are still performed by human beings; Ellwood himself states that his system “is absolutely dependent on the participation and cooperation of the entire health enterprise”.* It would seem clear that widely accepted guiding principles will be needed to influence behaviour and foster co-operation-to express the new moral imperative engendered by the situation. A fully developed ethics of evidence along the lines discussed here may provide the necessary conceptual framework-a conscious ‘mind to direct the proposed program of a ‘central nervous system’. I believe that the ethics of evidence is a deep and rich concept that is enhanced by development from a variety of viewpoints. The ideas presented by Till et al.,’ the model of the measurement iterative loop for the evaluation of evidence about interventions and the role of preference assessments, fit very well into this picture. Preference as defined by the authors-an internally consistent act of deliberation about something of importance-can be used as a basis of the rationality of choice discussed by Ellwood.‘f8 The work of Wennberg et al. 9 that they cite concerning treatment options for prostatic hypertrophy is an excellent example of a strategy for the creation, assessment, and communication of evidence. But the full scope of the ethics of evidence is even broader than Till et al. have indicated-
namely, as a foundation of the ethics of research. As stated earlier, the ethics of evidence presents a dual challenge: there is also the mandate to confront the ultimately irreducible nature of uncertainty. Brief reflection will reveal that quality of life questions are especially important in the exploration of this second, complex component. This can be illustrated with reference to the authors’ discussion of QOL issues in the treatment of early breast cancer, in particular the role of patients’ preferences in the choice between radical mastectomy and breast-conserving treatment. Preliminary studies seem to show that offering women a choice of treatment for early-stage breast cancer does not in itself prevent psychological distress.” In the event of an unfavourable clinical outcome patients may blame themselves for having made the wrong decision. In the balance being sought between the principles of autonomy and beneficence in the physician-patient relationship, this is seen as the risk of harm to the patient acting with autonomy, harm from making what is later perceived to have been the wrong decision. But major illness can also be viewed as confrontation with the fundamental questions of lifequestions far beyond the scope of scientific medicine. The anxiety of choice facing the unknown, the fear of suffering and death, and the need for courage to accept the consequences of one’s actions are all part of what it means to be human. In his book tracing the role of the physician from earliest times to the present, William May said in a discussion of contemporary paternalism: “Paternalism in medicine keenly experiences the absence of divine providence and substitutes a providence of its own, But it redefines providence. The providence it offers does not reckon with the turmoil of freedom within and the pain of suffering without. In order to protect its charges, this substitute providence withholds knowledge, cirand avoids coping with cumvents freedom, death.“” From this vantage point, the fear of the breast cancer patient when choosing her own treatment in exercise of her autonomy-described by Till et al. as an example of the risk of harm from making a wrong decision-is seen simply as one aspect of the fully conscious act of an adult human being. Such issues are central to the ethics of evidence, and they directly involve the concept of QOL. Acceptance of the ethics of evidence naturally leads to the notion of personal responsibility as a necessary counterpart to the principle of autonomy-responsibility in the face of medical Quality
of Life
Research
* Vol 1 .I992
275
V. Mik6
uncertainty. l2 It also calls for better education, to yield greater insight into the nature of medical evidence. What has been called ‘numeracy’ -facility with numbers and skill in quantitative reasoning-is along with literacy increasingly becoming a prerequisite for meaningful citizenship in a democratic society. But beyond scientific medicine, the total openness and awareness advocated by the ethics of evidence in turn invite attention to cultural resources that have helped humanity cope with suffering and death over the centuries. Another, especially poignant example is provided by the current controversy over physicianassisted suicide. Pain or fear of suffering-here again is the QOL issue-is what may drive a seriously ill person to seek this desperate solution. But numerous studies have described as a related problem the widespread ignorance of health care professionals about the effective use of analgesics and the diagnosis and treatment of psychological distress, so that many patients do not receive adequate pain and symptom management.13 The nature of suffering in general is now also the subject of renewed attention. Addressing this very complex situation illustrates both components of the proposed ethics of evidence.
References 1. Till JE, Sutherland HJ, Meslin ME. Is there a role for preference assessments in research on quality of life in oncology? Qua1 Life Res 1992; 1: 31-40. 2. Mike V. Toward an ethics of evidence-and beyond: Observations on technology and illness. Res PkiI Tech& 1989; 9: 101-113. 3. Mike V. Ethics, evidence, and uncertainty. Controlled Clin Trials 1990; 11: 153-156.
276
Quality of Life Research . Vol 1 . 1992
4. Tugwell P, Bennett KJ, Sackett DL, Haynes RB. The measurement iterative loop: a framework for the critical appraisal of need, benefits and costs of health interventions. J Chron Dis 1985; 38: 339-351. for the Protection of Human 5. National Commission Subjects of Biomedical and Behavioural Research. The Belmont Report: Ethical Principles and Guidelines@ the Protection of Human Subjects of Research. Washington, DC: DHEW Publication (OS) 78-0012,1978. Code. Trials of War Criminals before the 6. Nuremberg Nuremberg Military Tribunals under Control Council Law No. 10. Washington, DC: US Government Printing Office, 1949, ~012, pp. 181-182. 7. Sass HM. Reichsrundschreiben 1931: Pre-Nuremberg German regulations concerning new therapy and human experimentation. J Med Phil 1983; 8: 99-111. 8. Ellwood PM. Outcomes management: a technology of patient experience. New Engl J Med 1988; 318: 1549-1556. JE, Mulley AG, Hanley D, et al. An 9. Wennberg assessment of prostatectomy for benign urinary tract obstruction. Geographic variations and the evaluation of medical care outcomes. JAMA 1988; 259: 3027-3030. 10. Fallowfield LJ, Hall A. Psychosocial and sexual impact of diagnosis and treatment of breast cancer. Br Med Bull 1991; 47: 388-399. 11. May WF. The Physician’s Covenant: Images of the Healer in Medical Ethics. Philadelphia, PA: Westminster Press, 1983. uncertainties in medical 12. Mike V. Understanding evidence: Professional and public responsibilities. In: Mayo DG, Hollander RD, eds. Acceptable Evidence: Science and Values in Risk Management. New York: Oxford University Press, 1991: 115-136. 13. Foley KM. The relationship of pain and symptom management to patient requests for physicianassisted suicide. J Pain Symp Management 1991; 6: 289-297. (Received 17 July 1992; accepted 24 July 1992)
of Life Research,
1, pp. 273-276
Commentary
Quality of life research evidence
Department of Public Health, Cornell New York, NY 10021, USA.
University
and the ethics of
Medical
College,
In a recent article published in this journal, Till et al. discuss the role of preference assessments in quality of life (QOL) research in oncology.’ They suggest that such preference evaluations are a special case of a more general issue: the need to develop an ‘ethics of evidence’, meaning standards for the creation, assessment, and communication of evidence. They are referrin here to a proposal made by me a few years ago, 3 j3 and I welcome this opportunity to comment on their work and to further elucidate the concept. The authors present a context within which such an ethics of evidence could be developed-an adaptation of the ‘measurement iterative loop’ proposed by Tugwell et al. 4 as a framework for the critical appraisal of need, benefits, and costs of health interventions. This model represents the process of identification of a problem, development and evaluation of interventions, and reassessment of the problem, subdivided into a logical progression of seven stages each of which involves the use of scientific evidence. Till et al.’ make the point that QOL data have thus far received little attention in decision making in oncology, and that research is needed pertaining to the transfer of QOL information to both clinical practice and decisions about health policy. They suggest that in the case of new treatments affecting QOL there is a role for so-called preference studies and preference trials, and, using the above-mentioned multicomponent model for the ethics of evidence, they identify areas where such studies would be appropriate sources of evidence. The guiding principle throughout is that of informed, shared decision making.
Research Foundation
supported by and the Esther
@ 1992 Rapid Communications
funds from A. and Joseph
of Oxford
Ltd
the National Klingenstein
Science Fund.
1300 York Avenue,
These developments are very much along the lines I had envisioned in proposing the concept. A number of years ago, having observed at close hand the emergence of the new field of bioethics, I reached the conclusion that a special term was needed to focus on ethical aspects of uncertainty and statistical evidence in medicine. Participating in bioethics seminars and conferences addressing a wide range of issues, over and over again I was surprised to note that consideration of relevant quantitative aspects of the situation would be conspicuously absent from the discourse. Scholars in bioethics tend to come from the fields of philosophy, law or medicine, and many are not familiar with concepts and methods of statistical inference. This may be one of the reasons that the general question of scientific validity, including the poor quality of much clinical research and the lack of proper assessment of many medical procedures, has been all but ignored in the bioethics literature. This lack of awareness of the extent of uncertainty and of the fact that so much more could have been done by properly designed and implemented studies to clarify or even resolve a given problem, engenders a special pitfall: it may inadvertently keep some from seeing when ideology takes the place of evidence. Transmission to the secondary level, reporting by the mass media, only exacerbates the situation. One case in point was the highly publicised controversy involving Baby Jane Doe, the infant born in 1983 with spina bifida, an incomplete fusion of the spinal column.2 The issue at hand was the role of the US Government in protecting children with severe handicaps. Two surgical procedures are generally required for this disorder: closing the opening in the infant’s back to prevent infection, and placing a shunt to prevent brain damage from a build-up of fluid on the brain, Quality
of Life Research . Vol I .1992
273
V. Mike caused by an associated malformation of the brain stem. The baby was said to be suffering also from microcephaly - abnormally small head size-and thus destined for severe mental retardation in addition to her physical impairments. This was widely reported by the media in support of her parents’ decision to refuse treatment. The many uncertainties surrounding prognosis for spina bifida and the official testimony of two neurosurgeons that Baby Jane’s head size was consistent with normal intelligence were ignored in most discussions of the case and were not reported by the major news media.2 In early 1985 a neonatologist colleague visited the hospital in New York where Baby Jane had resided, to review her medical record. At that time her chart contained not one, but two records of her head size at birth, one showing normal and the other a borderline circumference. There was no indication of microcephaly. Convinced of the need to study and elucidate the role of evidence as an integral part of the ethics of modern medicine, I sought a term that would help call attention to the issues. Before deciding, I consulted a specialist in the bibliographies of the philosophy of science and technology and of applied ethics, who assured me that the concept of ‘ethics of evidence’ did not as yet exist in the literature. I used it for the first time in 1987, in a lecture that was published in 1989.2 The ethics of evidence, meaning-in concise but not exhaustive terms-standards for the creation, assessment, and communication of evidence, is proposed as an approach to medical uncertainty to be incorporated into the evolving scope of biomedical ethics. Its main tenet is two-fold: (1) there is a need to develop and disseminate the best possible scientific evidence as a basis for every phase of medical decision making, and (2) there is a need to increase awareness of, and come to terms with, the ultimately irreducible nature of uncertainty. This in turn implies the need to study and further clarify the complementary relationship of the concepts of evidence and uncertainty, in terms that are meaningful to nonspecialists. The ethics of evidence addresses the full spectrum of the health care process: biomedical research, clinical practice, administration, and health policy; it is meant to apply to all relevant professional groups, including the news media, as well as the general public. Such an ethics of evidence is strongly supported by the three basic principles of contemporary biomedical ethics, the principles of respect for persons, beneficence, and justice. Consonant with 274
Quality
of Life Research
. Vol 1 . 1992
the major traditions of Western thought, these principles were identified in the 1978 Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 5 Respect for persons, or autonomy, with its derivative concept of informed consent, has been the guiding theme of much of American bioethics discourse. This principle gives patients the right to make their own decisions about medical treatment. But no one can give a truly ‘informed consent to a procedure that has not been properly evaluated, since the information is just not available. The patient is frequently not even aware of the extent of medical uncertainty. The principle of beneficence and nonmaleficence - help or at least do no harm-dates back to Hippocrates and is directly relevant to an ethics of evidence. It is unethical to use powerful diagnostic and therapeutic procedures without sound assessment of their safety and effectiveness. From this it readily follows that clinical studies without proper statistical design are in turn unethical. These are, incidentally, not new insights. Quality of the proposed research was already addressed in Rule 2 of the 1947 Code of Nuremberg: “The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods of study, and not random and unnecessary in nature”. 6 The principle of justice, taken beyond the fair selection of research subjects, can be interpreted to mean equity of access to health care. It supports the ethics of evidence in an indirect, but very special way. If only scientifically validated procedures were reimbursed by third-party payers (government plans and private insurance carriers), the resulting savings could provide medical coverage for the many millions of Americans now without adequate health insurance. Seeking safe and effective procedures-the approach mandated by the ethics of evidence-would at the same time yield better health care for everyone. It is interesting to note that there is a document supporting the ethics of evidence predating the Code of Nuremberg. Legally binding regulations pertaining to new therapies and experimentation on humans, more stringent than the subsequent Nuremberg Code, were issued in Germany in 1931 and remained in effect throughout the Nazi period. The ethics of research and treatment, the quality of the research, informed consent, and professional responsibility were discussed explicitly and in detail. 7
Ethics of ezdence The ethics of evidence is thus not being proposed as something radically new, a new code of ethics, but primarily as a means of consciousness raising and a focus of discourse for all. The need for attention to these matters is urgent. The need and timeliness for an integrated program of medical technology assessment in the United States has been stated repeatedly, perhaps never more eloquently than was done by Paul Ellwood.* Ellwood seeks the establishment of a national program of ‘outcomes management’ or, in other words, a ‘technology of patient experience.’ This program would provide a permanent national medical data base linking medical interventions with health outcomes. As he sees it, “the fine line between chaos and democracy is rationality of choice”, and “the health care system has become an organism guided by misguided choices; it is unstable, confused, and desperately in need of a central nervous system that can help it cope with the complexities of modern medicine”. The notion of a central nervous system is a powerful metaphor. But it is one that requires careful analysis; a reductionist approach will not resolve the problem. The key functions in this structure are still performed by human beings; Ellwood himself states that his system “is absolutely dependent on the participation and cooperation of the entire health enterprise”.* It would seem clear that widely accepted guiding principles will be needed to influence behaviour and foster co-operation-to express the new moral imperative engendered by the situation. A fully developed ethics of evidence along the lines discussed here may provide the necessary conceptual framework-a conscious ‘mind to direct the proposed program of a ‘central nervous system’. I believe that the ethics of evidence is a deep and rich concept that is enhanced by development from a variety of viewpoints. The ideas presented by Till et al.,’ the model of the measurement iterative loop for the evaluation of evidence about interventions and the role of preference assessments, fit very well into this picture. Preference as defined by the authors-an internally consistent act of deliberation about something of importance-can be used as a basis of the rationality of choice discussed by Ellwood.‘f8 The work of Wennberg et al. 9 that they cite concerning treatment options for prostatic hypertrophy is an excellent example of a strategy for the creation, assessment, and communication of evidence. But the full scope of the ethics of evidence is even broader than Till et al. have indicated-
namely, as a foundation of the ethics of research. As stated earlier, the ethics of evidence presents a dual challenge: there is also the mandate to confront the ultimately irreducible nature of uncertainty. Brief reflection will reveal that quality of life questions are especially important in the exploration of this second, complex component. This can be illustrated with reference to the authors’ discussion of QOL issues in the treatment of early breast cancer, in particular the role of patients’ preferences in the choice between radical mastectomy and breast-conserving treatment. Preliminary studies seem to show that offering women a choice of treatment for early-stage breast cancer does not in itself prevent psychological distress.” In the event of an unfavourable clinical outcome patients may blame themselves for having made the wrong decision. In the balance being sought between the principles of autonomy and beneficence in the physician-patient relationship, this is seen as the risk of harm to the patient acting with autonomy, harm from making what is later perceived to have been the wrong decision. But major illness can also be viewed as confrontation with the fundamental questions of lifequestions far beyond the scope of scientific medicine. The anxiety of choice facing the unknown, the fear of suffering and death, and the need for courage to accept the consequences of one’s actions are all part of what it means to be human. In his book tracing the role of the physician from earliest times to the present, William May said in a discussion of contemporary paternalism: “Paternalism in medicine keenly experiences the absence of divine providence and substitutes a providence of its own, But it redefines providence. The providence it offers does not reckon with the turmoil of freedom within and the pain of suffering without. In order to protect its charges, this substitute providence withholds knowledge, cirand avoids coping with cumvents freedom, death.“” From this vantage point, the fear of the breast cancer patient when choosing her own treatment in exercise of her autonomy-described by Till et al. as an example of the risk of harm from making a wrong decision-is seen simply as one aspect of the fully conscious act of an adult human being. Such issues are central to the ethics of evidence, and they directly involve the concept of QOL. Acceptance of the ethics of evidence naturally leads to the notion of personal responsibility as a necessary counterpart to the principle of autonomy-responsibility in the face of medical Quality
of Life
Research
* Vol 1 .I992
275
V. Mik6
uncertainty. l2 It also calls for better education, to yield greater insight into the nature of medical evidence. What has been called ‘numeracy’ -facility with numbers and skill in quantitative reasoning-is along with literacy increasingly becoming a prerequisite for meaningful citizenship in a democratic society. But beyond scientific medicine, the total openness and awareness advocated by the ethics of evidence in turn invite attention to cultural resources that have helped humanity cope with suffering and death over the centuries. Another, especially poignant example is provided by the current controversy over physicianassisted suicide. Pain or fear of suffering-here again is the QOL issue-is what may drive a seriously ill person to seek this desperate solution. But numerous studies have described as a related problem the widespread ignorance of health care professionals about the effective use of analgesics and the diagnosis and treatment of psychological distress, so that many patients do not receive adequate pain and symptom management.13 The nature of suffering in general is now also the subject of renewed attention. Addressing this very complex situation illustrates both components of the proposed ethics of evidence.
References 1. Till JE, Sutherland HJ, Meslin ME. Is there a role for preference assessments in research on quality of life in oncology? Qua1 Life Res 1992; 1: 31-40. 2. Mike V. Toward an ethics of evidence-and beyond: Observations on technology and illness. Res PkiI Tech& 1989; 9: 101-113. 3. Mike V. Ethics, evidence, and uncertainty. Controlled Clin Trials 1990; 11: 153-156.
276
Quality of Life Research . Vol 1 . 1992
4. Tugwell P, Bennett KJ, Sackett DL, Haynes RB. The measurement iterative loop: a framework for the critical appraisal of need, benefits and costs of health interventions. J Chron Dis 1985; 38: 339-351. for the Protection of Human 5. National Commission Subjects of Biomedical and Behavioural Research. The Belmont Report: Ethical Principles and Guidelines@ the Protection of Human Subjects of Research. Washington, DC: DHEW Publication (OS) 78-0012,1978. Code. Trials of War Criminals before the 6. Nuremberg Nuremberg Military Tribunals under Control Council Law No. 10. Washington, DC: US Government Printing Office, 1949, ~012, pp. 181-182. 7. Sass HM. Reichsrundschreiben 1931: Pre-Nuremberg German regulations concerning new therapy and human experimentation. J Med Phil 1983; 8: 99-111. 8. Ellwood PM. Outcomes management: a technology of patient experience. New Engl J Med 1988; 318: 1549-1556. JE, Mulley AG, Hanley D, et al. An 9. Wennberg assessment of prostatectomy for benign urinary tract obstruction. Geographic variations and the evaluation of medical care outcomes. JAMA 1988; 259: 3027-3030. 10. Fallowfield LJ, Hall A. Psychosocial and sexual impact of diagnosis and treatment of breast cancer. Br Med Bull 1991; 47: 388-399. 11. May WF. The Physician’s Covenant: Images of the Healer in Medical Ethics. Philadelphia, PA: Westminster Press, 1983. uncertainties in medical 12. Mike V. Understanding evidence: Professional and public responsibilities. In: Mayo DG, Hollander RD, eds. Acceptable Evidence: Science and Values in Risk Management. New York: Oxford University Press, 1991: 115-136. 13. Foley KM. The relationship of pain and symptom management to patient requests for physicianassisted suicide. J Pain Symp Management 1991; 6: 289-297. (Received 17 July 1992; accepted 24 July 1992)
