Original Article. Published by Elsevier. All rights reserved. Key Words Sedation, definition, palliative care, multidimensional scaling

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1 Vol. 25 No. 4 April 2003 Journal of Pain and Symptom Management 357 Original Article Similarity and Difference Among Standard Medical Care, Palliative Sedation Therapy, and Euthanasia: A Multidimensional Scaling Analysis on Physicians and the General Population s Opinions Tatsuya Morita, MD, Kei Hirai, PhD, Tatsuo Akechi, MD, PhD, and Yosuke Uchitomi, MD, PhD Seirei Hospice (T.M.), Seirei Mikatabara Hospital, Shizuoka; Graduate School of Human Sciences (K.H.), Osaka University, Osaka; and Psycho-Oncology Division (T.A., Y.U.), National Cancer Center Research Institute East, Chiba, Japan Abstract There is a strong controversy about the differences among standard medical care, palliative sedation therapy, and euthanasia in recent medical literature. To investigate the similarities and differences among these medical treatments, a secondary analysis of two previous surveys was performed. In those surveys, Japanese physicians and the general population were asked to identify their treatment recommendations or preferences for intolerable and refractory distress in the terminal stage. The options were standard medical care without intentional sedation, mild sedation, intermittent deep sedation, continuous deep sedation, and physician-assisted suicide (PAS)/euthanasia. Multidimensional scaling analysis mapped their responses. The physician responses were clustered into 3 groups: 1) standard medical care, 2) palliative sedation therapy including mild, intermittent deep, continuous deep sedation, and 3) PAS/ euthanasia. The general population s responses were classified into 3 subgroups: 1) standard medical care, 2) mild and intermittent deep sedation, and 3) a group including continuous deep sedation and PAS/euthanasia. Physicians placed continuous deep sedation closer to mild and intermittent sedation, while the general population mapped it closer to PAS/euthanasia. In conclusion, physicians and general population can generally differentiate the three approaches standard medical care, palliative sedation therapy, and PAS/euthanasia. We recommend that mild and intermittent deep sedation should be differentiated from standard medical care, and that continuous deep sedation should be dealt with separately from other types of sedation. Clear definitions of palliative sedation therapy will contribute to quality discussion. J Pain Symptom Manage 2003;25: U.S. Cancer Pain Relief Committee. Published by Elsevier. All rights reserved. Key Words Sedation, definition, palliative care, multidimensional scaling Address reprint requests to: Tatsuya Morita, MD, Seirei Hospice, Seirei Mikatabara Hospital, 3453 Mikatabara-cho, Hamamatsu, Shizuoka , Japan. Accepted for publication: July 16, U.S. Cancer Pain Relief Committee /03/$ see front matter Published by Elsevier. All rights reserved. doi: /s (02)00684-x

2 358 Morita et al. Vol. 25 No. 4 April 2003 Introduction In clinical practice, sedation for symptom relief is required for a significant number of terminally ill cancer patients. Nonetheless, there continues to be controversy about the differences among standard medical care, palliative sedation therapy, and euthanasia. 1 5 Some palliative care specialists maintain that sedation should be understood as an ordinary symptomatic treatment, 6,7 while others insist that sedation can be a type of euthanasia in which the physician intends to hasten death. 2,8,9 Lack of clear definition and conceptualization of sedation is a major contribution to this controversy. 4,10 Operational criteria for palliative sedation therapy recently have been proposed, 11 with palliative sedation therapy being defined as the use of sedative medication to relieve intolerable and refractory distress by reducing patient consciousness. Palliative sedation therapy is distinguished from standard medical treatment because it includes intentional reduction in patient consciousness, and sedation is differentiated from euthanasia because its primary aim is not to shorten patient life but to relieve severe symptoms. Sedation is further classified into several subgroups according to its level and duration: mild sedation (to maintain consciousness so that patients can communicate with caregivers), deep sedation (to achieve almost or complete unconsciousness), intermittent sedation (to provide some periods when patients are alert), and continuous sedation (to continue to alter patient consciousness until they die). Although these definitions seem logical and practical, no empirical evidence supports this conceptualization. The primary aim of this study was to examine the conceptual validity of the proposed criteria for palliative sedation therapy by investigating the similarities and differences among standard medical care, the subcategories of palliative sedation therapy proposed, and medical acts to hasten death using a multidimensional scaling technique on actual survey data. Methods This study is a secondary analysis of two previous surveys on the attitudes toward the preferred treatment for refactory distress in the terminal stage of life. 12,13 The first was a survey of 697 Japanese oncologists and palliative care physicians from the Japanese Association of Clinical Cancer Centers and the Japanese Association of Hospice and Palliative Care Units, in which the physicians were presented with a vignette and requested to identify their recommended treatment for a terminally ill cancer patient with intolerable and refractory dyspnea or existential distress. The physicians rated the levels of their recommendations on a 4-point Likert-type scale ( unthinkable, difficult to consider, consider as a possibility, and consider as a strong possibility ) for each prepared choice: 1) medical care without intentional sedation, 2) psychological care without intentional sedation, 3) mild sedation with opioids, 4) mild sedation with psychotropics, 5) intermittent deep sedation, 6) continuous deep sedation, and 7) PAS/euthanasia. The second study was a survey of the general population using a convenience sample of 457 Japanese. Participants were asked to identify the degree to which they would want each treatment for severe physical or psychological distress refractory to optimal care on a 4-point Likert-type scale ( absolutely not want, probably not want, probably want, and strongly want ). The prepared options were: 1) care without intentional sedation, 2) mild sedation, 3) intermittent deep sedation, 4) continuous deep sedation, and 5) PAS/euthanasia. Definitions In this report, palliative sedation therapy and its subcategories were defined following the proposed criteria. 11 Also, standard medical care meant medical care without intentional sedation, psychological care without intentional sedation, or care without intentional sedation in the previous surveys. As medical terms such as sedation and euthanasia can be ambiguous and misinterpreted, they were replaced throughout the survey by descriptive phrases. For instance, mild sedation was expressed as the administration of sedatives to the point where the patient is somnolent with the primary aim that the patient does not experience suffering in the physician survey, and administration of sleeping drugs with adjustments so that I may become drowsy all day, feeling no physical distress, but can achieve simple communications to people in

3 Vol. 25 No. 4 April 2003 Medical Care Palliative Sedation, and Euthanasia 359 the general population survey. Continuous deep sedation was paraphrased as continuous administration of sedatives to the point where the patient almost (completely) loses consciousness, with the primary aim that the patient does not experience suffering in the physician survey, and administration of sleeping drugs so that I can sleep deeply all day, feeling no physical distress, even if I cannot talk with people in the general population survey. PAS/euthanasia was paraphrased as the administration of medication for the purpose of hastening the patient s death in the physician survey, and I would desire methods that intentionally shorten my life in the general population survey. Statistical Analyses Multidimensional scaling analysis based on the Euclidean distance model of stimulus configuration of measures was used to cluster the treatment options. This statistical method can visualize similarities of endorsements by making a matrix of correlation coefficients. Kruskal s stress values were used as a badness-of-fit measure, and the two dimensional solution was adopted because of its simplicity, ease of interpretation, and minimum improvement of stress and r 2 in the three-dimensional solution. All analyses were performed with the Statistical Package for the Social Sciences (ver. 9.0). Results Figures 1 and 2 show the structure of standard medical care, subcategories of palliative sedation therapy, and PAS/euthanasia on the basis of physicians recommendations and general population s preferences, respectively. The horizontal dimension was interpreted as personal appraisal of the medical interventions, and the vertical dimension was labeled as the conscious levels. Kruskal s stress values ( 0.07) and proportion of variance of data ( 0.97) indicated that this solution were valid solution and accounted over 97% variance. The physician responses were clustered into 3 groups: 1) standard medical care, 2) palliative sedation therapy including mild, intermittent deep, and continuous deep sedation, and 3) PAS/euthanasia (Figure 1). The preference responses from the general population were classified into 3 subgroups: 1) standard medical care, 2) mild and intermittent deep sedation, and 3) a group including continuous deep sedation and PAS/euthanasia (Figure 2). Continuous deep sedation was placed closer to mild and intermittent deep sedation in the physician responses, while it was mapped closer to PAS/euthanasia in the general population data. Discussion One of the most important findings of this study is that both physicians and the general population differentiated mild and intermittent deep sedation from standard medical care that did not include intentional sedation. Whether clinicians should deal with mild and intermittent deep sedation as standard palliative care or as a type of palliative sedation therapy is not Fig. 1. The structure of standard medical care, palliative sedation therapy, and PAS/euthanasia on the basis of physician s recommendation. Large (small) distances between medical treatments imply low (high) similarity in patterns of respondents. PAS: Physician-assisted suicide.

4 360 Morita et al. Vol. 25 No. 4 April 2003 Fig. 2. The structure of standard medical care, palliative sedation therapy, and PAS/euthanasia on the basis of the general population s preference. Large (small) distances between medical treatments imply low (high) similarity in patterns of respondents. PAS: Physician-assisted suicide. constant in the existing palliative care literature. Mild sedation was included in sedation in Ventafridda et al. s and Morita et al. s studies, which had higher sedation rates of 53% and 48%, respectively, 14,15 whereas Fainsinger et al. s and Peruselli et al. s studies defined sedation as total loss of consciousness and had lower sedation rates of 7%, 16%, and 25%, respectively Stone et al. separately reported sedative use for symptom control (44% of all deaths) and sedation (26%). 19 Inconsistency when including or excluding mild and intermittent sedation is thus a strong cause of difficulty in interpreting research findings. 4 From a clinical point of view, a palliative care specialist comments that mild sedation induced by low-dose sedatives aims not to decrease patient consciousness but is adjuvant symptomatic treatment, 6 and another expert suggests that sedation is one of the common high-risk medical procedures requiring high quality skills and knowledge from physicians and a careful evaluation of the potential benefits and risks. 7 This study revealed that both physicians and the general population differentiated mild and intermittent deep sedation from standard medical care, possibly because the former has a special intent of allowing reduced patient alertness. We, therefore, recommend that mild and intermittent deep sedation should be treated as a subcategory of palliative sedation therapy, not as a part of a standard medical practice that principally does not include intentional reduction in patient consciousness. The second important, and the most impressive finding of this study, is that physicians placed continuous deep sedation closer to mild and intermittent deep sedation, but the general population mapped it closer to PAS/euthanasia. The difference between euthanasia and terminal sedation, described as continuous deep sedation in this study, has been the focus of strong controversy in the recent medical literature. 2,3,5 Although the U.S. Supreme Court undermined the distinction, 20 Billings et al. introduced the concept of slow euthanasia and maintained that terminal sedation could be a type of euthanasia because physicians perform sedation with two intents: to palliate suffering and to hasten death. 8 Similarly, Orentlicher asserts that terminal sedation is a form of euthanasia because it includes two intentional acts of physicians, without which the patients would survive longer: reducing patient consciousness and withholding or withdrawing artificial fluid and nutrition support. 9 Several experts also do not completely agree with the ethical appropriateness of the principle of double effect, due to the ambiguity and complexity of physician intentions in performing sedation. 21,22 This study suggested, however, that Japanese physicians actually perceived continuous deep sedation as a subtype of palliative sedation therapy that predominantly intends to achieve symptom palliation, and differentiated it from euthanasia that primarily aims to hasten death.

5 Vol. 25 No. 4 April 2003 Medical Care Palliative Sedation, and Euthanasia 361 That is, physicians can distinguish continuous deep sedation from acts to directly cause death at least in their recommendations for vignettes. Of special note is that, contrary to the physicians view, the general population located continuous deep sedation closer to PAS/euthanasia than to mild and intermittent deep sedation. One of the potential interpretations of this result is that physicians believe that the purpose of the medical treatment is of principal importance, while the general population feels the purpose is no more essential than the outcome. This explanation is supported by expert comments that the principle of double effect places too much value on the physicians intention, but that the predicted outcome of the medical acts is very important, regardless of their intent. 21,22 Another interpretation is that physicians are chiefly concerned about the effects of medical intervention on patient life, while the general population puts a higher value on whether it affects their mental capacity. This explanation corresponds to the empirical findings from good death surveys, which reveal that mental clarity is regarded as more important in achieving a good dying process to patients than by physicians, 23,24 and a preliminary finding that sedation is often labeled as psychological euthanasia. 25 To identify the origins of this discrepancy in attitudes toward continuous deep sedation between physicians and the general population is beyond the aim of this study, and should be assessed by further research. However, this finding suggests that it is reasonable to deal with continuous deep sedation separately from other types of sedation, such as mild and intermittent deep sedation, 26,27 due to the unique characterizations identified by the general population. This study has several limitations. First, as the response rates of original surveys are relatively low (50% in physician survey, 53% in the general population survey) and the targeted subjects were not representative of overall Japanese physicians and general populations, 12,13 a potential selection bias exists. Second, as this study is a secondary analysis of previously collected data, the differences in the questionnaire formats might influence the results. Third, the cross-sectional nature of this study does not allow any conclusions to be drawn about the stability of the findings. Finally, all participants of this study were Japanese, and the application of the results to other ethnic groups is not automatically supported. In conclusion, physicians and the general population can generally differentiate three approaches, standard medical care, palliative sedation therapy, and medical acts to intentionally hasten death. Both physicians and the general population clearly differentiate mild and intermittent deep sedation from standard medical care and PAS/euthanasia. However, whereas physicians placed continuous deep sedation closer to mild and intermittent deep sedation, the general population mapped it closer to PAS/euthanasia. We recommend that researchers clearly define the term sedation, such as mild sedation, intermittent deep sedation, and continuous deep sedation. Acknowledgments This work was partly supported in part by a Grant-in-Aid for Cancer Research (9-31) and the Second Term Comprehensive 10-year Strategy for Cancer Control from the Ministry of Health and Welfare, Japan. We would like to thank Yumi Okazaki, BA, Yuriko Sugawara, MD, and Satoshi Chihara, MD, for carrying out the original surveys. References 1. Cowan JD, Walsh D. Terminal sedation in palliative medicine: definition and review of the literature. Support Care Cancer 2001;9: Quill TE, Byock IR. Responding to intractable terminal suffering: the role of terminal sedation and voluntary refusal of food and fluids. Ann Intern Med 2000;132: Rousseau P. The ethical validity and clinical experience of palliative sedation. Mayo Clin Proc 2000; 75: Sales JP. Sedation and terminal care. Eur J Palliat Care 2001;8: Sulmasy DP. The rule of double effect. Clearing up the double talk. Arch Intern Med 1999;159: Hardy J. Sedation in terminally ill patients. Lancet 2000;356: Wein S. Sedation in the imminently dying patient. Oncology 2000;14: Billings JA, Brock SD. Slow euthanasia. J Palliat Care 1996;12(4): Orentlicher D. The Supreme Court and physi-

6 362 Morita et al. Vol. 25 No. 4 April 2003 cian-assisted suicide. Rejecting assisted suicide but embracing euthanasia. N Engl J Med 1997;337: Morita T, Tsuneto S, Shima Y. Proposed definitions of terminal sedation. Lancet 2001;358: Morita T, Tsuneto S, Shima Y. Proposed definition of sedation for symptom relief: a systematic literature review and a proposal of operational criteria. J Pain Symptom Manage 2002;24: Morita T, Akechi T, Sugawara Y, et al. Practices and attitudes of Japanese oncologists and palliative care physicians concerning terminal sedation: a nationwide survey. J Clin Oncol 2002;20: Morita T, Hirai K, Okazaki Y. Preferences in palliative sedation therapy in the Japanese general populations. J Palliat Med 2002;5: Morita T, Inoue S, Chihara S. Sedation for symptom control in Japan: the importance of intermittent use and communication with family members. J Pain Symptom Manage 1996;12: Ventafridda V, Ripamonti C, De Connno F, et al. Symptom prevalence and control during cancer patients last days of life. J Palliat Care 1990;6(3): Fainsinger R, Miller MJ, Bruera E, et al. Symptom control during the last week of life on a palliative care unit. J Palliat Care 1991;7(1): Fainsinger R, de Moissac D, Mancini I, Onechuk D. Sedation for delirium and other symptoms in terminally ill patients in Edmonton. J Palliat Care 2000; 16(2): Peruselli C, Giulio PD, Toscani F, et al. Home palliative care for terminal cancer patients: a survey on the final week of life. J Pain Symptom Manage 1999;13: Stone P, Phillips C, Spruyt O, et al. A comparison of the use of sedatives in a hospital support team and in a hospice. Palliat Med 1997;11: Vacco v. Quill. 117 S. Ct. 2293, Hunt R. A critique of the principle double effect in palliative care. Prog Palliat Care 1998;6: Loewy E. Terminal sedation, self-starvation, and orchestrating the end of life. Arch Intern Med 2001; 161: Steinhauser KE, Clipp EC, McNeilly M, et al. In search of a good death: observations of patients, families, and providers. Ann Intern Med 2000;132: Steinhauser KE, Christakis NA, Clipp EC, et al. Factors considered important at the end of life by patients, family, physicians, and other care providers. JAMA 2000;284: Foundras JC. Sedation and ethical contradiction. Eur J Palliat Care 1996;3: Cherny NI. Sedation in response to refractory existential distress: walking the fine line. J Pain Symptom Manage 1998;16: del Rosario MAB, Martin AS, Ortega JJM, Feria M. Temporary sedation with midazolam for control of severe incident pain. J Pain Symptom Manage 2001;21: