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Biomedical subjects

Daniel P Sulmasy

Publications and source records attributed to Daniel P Sulmasy.

At least 19 recordsLinked to original sources

Cancer care, money, and the value of life: whose justice? Which rationality?

Cost-containment in oncology is a moral issue. While economists use the word "rationing" to describe all limitations on resource utilization that result from human choice, the ordinary language distinction between allocation and rationing is morally meaningful and can help oncologists to determine their proper moral role in cost-containment. It is argued that oncologists should not be required to ration at the bedside, nor should they be given financial incentives to practice frugally, nor should they be subjected to a variety of bureaucratic mechanisms to control costs indirectly. In addition, it is argued that the fact that treatments have a price does not logically imply that patients have a price. Cost-effectiveness analysis is often suggested as a means of deciding how best to allocate resources, but some of its many ethical limitations are discussed. The alternative is an open, public, participatory process about how to ration care, abandoning the formulaic pretenses of cost-effectiveness analysis, but with a commitment to reason, good will, and common sense. Oncologists would then be free to advocate for their patients within the constraints imposed by this public process.

Cost Control↗

Spiritual issues in the care of dying patients: ". . . it's okay between me and god".

Spiritual issues arise frequently in the care of dying patients, yet health care professionals may not recognize them, may not believe they have a duty to address these issues, and may not understand how best to respond to their patients' spiritual needs. The case of a patient with a strong religious belief in a miraculous cure of metastatic pancreatic cancer is used to explore how better understanding of this belief and more explicitly spiritual conversation with the patient by his treating team might have provided opportunities for an improved plan of care. This article distinguishes spirituality from religion; describes the salient spiritual needs of patients at the end of life as encompassing questions of meaning, value, and relationship; delineates the role physicians ought to play in ascertaining and responding to those needs; and discusses the particular issue of miracles, arguing that expectations of miraculous cure ought not preclude referral to hospice care.

Hospice Care↗

Promethean medicine: spirituality, stem cells, and cloning.

Every ethos implies a mythos. That is, every ethical system depends upon some fundamental story disclosing its assumptions about human nature, freedom, good and evil, and the workings of the universe. A romanticized version of the myth of Prometheus, who stole fire from the gods and was punished by being chained to a rock and having his liver plucked out by vultures, seems to under-gird much of contemporary healthcare. Christianity offers a different view--one in which the universe is not a zero sum game and human beings do not need to steal fire because God has already freely given them all the fire they need in Christ and in his spirit. A critical virtue for physicians, taught by Christianity, is sagacious engagement--the ability to engage the world practically, discerning what can and should be changed and what should be accepted as unchangeable and given. The illusory quest for immortality through the practice of regenerative medicine using stem cells is a gross violation of that virtue.

Christianity↗

A prospective trial of a new policy eliminating signed consent for do not resuscitate orders.

BACKGROUND: Some institutions require patients and families to give signed consent for Do Not Resuscitate (DNR) orders, especially in New York State. As this may be a barrier to discussions about DNR orders,we changed a signed consent policy to a witnessed verbal consent policy,simplified and modified the DNR order forms, and educated the staff at 1 hospital, comparing the effects with an affiliated hospital where the policy was not changed. DESIGN: Prospective natural experiment with intervention and comparison sites. SUBJECTS AND MEASUREMENTS: Pre- and postintervention, we surveyed house officers' confidence and attitudes, reviewed charts to assess the number of concurrent care concerns (CCCs) addressed per DNR order (e.g., limits on intubation or blood products or need for hospice),and at the intervention hospital, measured the stress levels of surrogates consenting for DNR orders using the Horowitz Impact of Event Scale. We also surveyed staff perceptions about the policy following the change. RESULTS: At the intervention hospital, the percentage of house officers reporting low confidence in their ability to obtain consent for DNR orders declined postintervention (24% to 7%, P=.002), while there was no significant change at the comparison hospital (20% vs 15%, P=.45).Among intervention hospital house officers, there were declines in percent reporting difficulty talking to patients and families about DNR orders, but no significant changes at the comparison hospital.At the intervention hospital, the mean number of CCCs/DNR order Increased (1.0 pre to 4.2 post, P<.001). but did not change significantly(1.2 pre to 1.4 post) at the comparison hospital. The mean total stress score for intervention hospital surrogates declined postintervention(23.6 to 17.3, P=.02), indicating lower stress. House officers(98%), attendings (59%), and nurses (79%} thought the new policy was better for families. CONCLUSIONS: The policy change was well received and associated with improved house officer attitudes, more attention to patients'concurrent care concerns, and decreased surrogate stress. The results suggest that DNR orders can be made simpler and clearer, and raise questions about policies requiring signed consent for DNR orders.

Humans↗

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials.

BACKGROUND: There is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials. METHODS: Surveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency-type numeracy was assessed using a multiple-choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in "40% of cases like yours." In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified. RESULTS: The correct frequency-type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief-type answer, "The doctor is 40% confident that the treatment will control my cancer." In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies. CONCLUSIONS: Because the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment.

Adult↗

"Diseases and natural kinds".

David Thomasma called for the development of a medical ethics based squarely on the philosophy of medicine. He recognized, however, that widespread anti-essentialism presented a significant barrier to such an approach. The aim of this article is to introduce a theory that challenges these anti-essentialist objections. The notion of natural kinds presents a modest form of essentialism that can serve as the basis for a foundationalist philosophy of medicine. The notion of a natural kind is neither static nor reductionistic. Disease can be understood as making necessary reference to living natural kinds without invoking the claim that diseases themselves are natural kinds. The idea that natural kinds have a natural disposition to flourish as the kinds of things that they are provides a telos to which to tether the notion of disease - an objective telos that is broader than mere survival and narrower than subjective choice. It is argued that while nosology is descriptive and may have therapeutic implications, disease classification is fundamentally explanatory. Sickness and illness, while referring to the same state of affairs, can be distinguished from disease phenomenologically. Scientific and diagnostic fallibility in making judgments about diseases do not diminish the objectivity of this notion of disease. Diseases are things, not kinds. Injury is a concept parallel to disease that also makes necessary reference to living natural kinds. These ideas provide a new possibility for the development of a philosophy of medicine with implications for medical ethics.

Diagnosis↗

When patients lack capacity: the roles that patients with terminal diagnoses would choose for their physicians and loved ones in making medical decisions.

Current approaches to end-of-life decision making are widely considered inadequate. We explored these complexities by examining how patients with terminal diagnoses would choose to involve their physicians and loved ones in making medical decisions, assuming they were able and unable to participate. Cross-sectional interviews of 130 patients recently diagnosed with fatal conditions were conducted. Patients were recruited from two academic medical centers using a modification of the Decision Control Preferences Scale, ranging from independent decision making to decision making that relies upon others. Patients were asked how they would balance their own wishes relative to the input of physician and loved ones in making medical decisions, and to weigh the input of loved ones relative to physician. Most patients (52%), assuming they had the capacity, would opt to share decision making with their physicians, but 15% would defer to their physicians and 34% would make decisions independently. Similarly, 44% would share decision making with their loved ones, but fewer (6%) would defer to their loved ones. Thirty-nine percent would rely upon their physicians' judgments about what would be best for them rather than their own wishes if they became unconscious, compared with 15% who would do so if they were conscious (P < 0.001). Nonetheless, patients were more likely to weigh their loved ones' input more heavily than their physicians' input if they were unconscious (33%) than if they were conscious (7%, P = 0.05). Race, religion, gender, diagnosis, and health status were largely unassociated with patients' decision control preferences. Patients with terminal diagnoses report a wide diversity of decision control preferences, but most would opt to share decision making with their physicians and loved ones. If unable to decide for themselves, they shift toward greater reliance on physician input relative to their own wishes but would weigh loved ones' input more heavily than physician input. Deciding for patients who cannot speak for themselves may be more complex than has previously been reflected in law, policy, or clinical ethics.

Advance Directives↗

The quality of care plans for patients with do-not-resuscitate orders.

BACKGROUND: Care plans for patients with do-not-resuscitate (DNR) orders often fail to define limits other than cardiopulmonary resuscitation and fail to address other patient care needs. We studied the explicitness and comprehensiveness of care plans for patients with DNR orders and what factors were associated with this aspect of the quality of their care. METHODS: A cross-sectional study was conducted at Georgetown University Medical Center (GUMC), Washington, DC, and St Vincent Catholic Medical Centers (SVCMC), St Vincent's Hospital-Manhattan, New York, NY. Participants included 189 consecutive medical inpatients with DNR orders. RESULTS: A previously validated medical chart review technique termed concurrent care concerns (CCCs) measured whether 11 possible patient care needs had been addressed within 2 days of the DNR order. Reasons for the DNR order were documented in only 55% of cases, and a consent conversation was documented in only 69%. The mean number of total CCCs per DNR order was 1.55 (1.84 at GUMC and 1.29 at SVCMC; (P =.007). In a multivariate logistic regression analysis of low ( or=2) CCCs, patients with malignancy (P =.002), higher APACHE III (Acute Physiology and Chronic Health Evaluation III) scores (P =.007), and a documented consent conversation (P =.009) and those at Georgetown (P =.005) were more likely to have high attention to CCCs. Patients with dementia were the least likely to have high attention to CCCs. CONCLUSIONS: Documented consent conversations and care plans for patients with DNR orders are less than ideal. Care plans differ in quality by diagnosis, institution, and whether or not a consent conversation is documented. These observations might help to guide interventions that aim to improve the care of patients with DNR orders.

APACHE↗

The clinician as investigator: participating in clinical trials in the practice setting.

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of trials needed to properly evaluate them. The majority of patients treated today, many of whom could be eligible for participation in these studies, are seen in community hospitals and medical practices that are not affiliated with an academic medical center. Thus, there is a demonstrable need for physicians in private practice to enlist as investigators in these trials. This article is intended to encourage those physicians by describing the need and providing the rationale for their participation. It covers basic requirements for participating in clinical trials and outlines ethical, regulatory, financial, and other logistical issues of importance for the potential investigator and provides an algorithm for selecting a study for participation. Finally, the appendices review basic elements of study design and statistical principles, which may be of interest to a potential investigator.

Choice Behavior↗

The correlation between patient characteristics and expectations of benefit from Phase I clinical trials.

BACKGROUND: Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials. METHODS: Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data. RESULTS: Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy. CONCLUSIONS: Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process.

Adult↗