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The ethical basis of the precautionary principle in health care decision making.

This article explores the relation between the precautionary and health care decision making. Decision making in medical practice as well as health policy is characterized by uncertainty. On the level of clinical practice for example, one never knows in advance whether one has made the right diagnosis or has opted for the right treatment. Though medical decisions have a risk on serious harms and burdens, the precautionary principle is not applicable to health care. This principle holds that one should not act when there is no scientific proof that no harms will result from a medical act or a policy decision. However, in clinical practice there is a duty to act. Physicians have an obligation to do good to their patients and have to weigh the benefits against possible harms and burdens. The basis virtue of medical decision making is not avoidance of risks, as stated in the precautionary principle, but the prudent assessment of benefits, burdens, and harms, in relation to other ethical principles like respect for autonomy and justice. The precautionary principle does play a role in health care, but it should never rule medical decision making as an absolute principle. This is not only true for clinical decision making, but also for the area of health policy. Physicians and other health care decision makers need to have knowledge about the possible effects of treatments or the precision of diagnostic procedures in order to reduce harm and promote well-being. Evidence-based medicine may contribute to the wisdom of health care decision makers, but this evidence-based wisdom should always be applied under the guidance of prudence, which is the central virtue of health care decision making.

Bioethics↗

Questioning the decision-making capacity of surrogates.

When patients are unable to make medical decisions for themselves due to cognitive impairment, surrogate decision makers are often called on to guide the medical team. Important to any decision made on behalf of the patient is that the decision reflects the values and preferences of the patient in light of the patient's clinical status and prognosis. Challenges arise for the medical team when surrogates themselves have questionable decision-making capacity due to psychosocial issues, conflict of interest, or the obvious projection of their own personal values and treatment preferences instead of the patient's. Even if an alternative surrogate is available, there is no consensus on when and how to switch from the primary surrogate to the alternative surrogate. This paper uses a clinical case to explore the notion of surrogate decision-making capacity, offering guidance for determining when it is appropriate to defer to an alternative surrogate, as well as guidance for managing the process of appointing the alternative as the new primary decision maker.

Advance Directives↗

Risk characterization: A bridge to informed decision making.

Regulatory decisions should be made in the most expert and informed way since they are precipitated by real and perceived threats to human health, under the glare of public scrutiny. In 1994, the National Research Council (NRC) reported that the U.S. Environmental Protection Agency's (USEPA's) overall approach to assessing risks is fundamentally sound, but the Agency must more clearly establish the scientific and policy basis for risk estimates and better communicate the associated uncertainties. On March 21, 1995, USEPA issued a risk characterization policy and guidance. In this policy, an effective risk characterization must fully and clearly characterize risks and disclose the scientific analysis, uncertainties, assumptions, and science policy that underlie decisions throughout the risk assessment process. A number of regulatory reform bills which required risk characterization as part of all Federal risk assessments were introduced by the 104th Congress. The purpose of this workshop was to familiarize Society of Toxicology members with: (1) key elements to be considered in risk characterization and (2) new advances in risk characterization addressed by Federal and State agencies, industry, academia, NRC, and Presidential/Congressional Commission on Risk Assessment and Risk Management. Furthermore, the main objective was to engage the audience in discussing the proper role of science in risk assessment-risk management interface to make informed decisions in the face of scientific uncertainty.

Decision Making↗

An integrated approach to ethical decision-making in the health team.

When making ethical decisions there are different perspectives that health care professionals may use. This may lead to conflict and insufficient co-operation between the members of the health team. Two of these perspectives are the ethics of justice and the ethics of care. In a bid to gain a better understanding of the nature of ethical decision-making in the health team, a comparison was drawn between the ethics of justice and the ethics of care. The investigation into and comparison between the ethics of justice and the ethics of care revealed that the deficiencies in each of the two perspectives in isolation, in fact, necessitate the application of a combination of both perspectives. The aim of the article is to describe how the members of the health team can, in an integrated manner, apply both the ethics of justice and the ethics of care in their ethical decision-making. The central argument of the article is based on the following premises: (1) the inadequacy of the ethics of justice and the ethics of care in isolation necessitates that both these perspectives be applied; (2) the application of both these perspectives again requires an extended rationality and discourse and (3) discourse, in its turn, requires that the emphasis falls on a specific telos and that the participants in the discourse be endowed with certain virtues in order to abide by the rules of discourse.

Communication↗

Decision-making in the ICU: perspectives of the substitute decision-maker.

OBJECTIVE: To describe the substitute decision-makers' perspectives related to decision-making in the intensive care unit (ICU) and to determine those variables associated with their overall satisfaction with decision-making. DESIGN: Prospective, multicenter, cohort study. SETTING: Six Canadian university-affiliated ICUs. PATIENTS AND PARTICIPANTS: We distributed a validated, self-administered questionnaire assessing 21 key aspects of communication and decision-making to substitute decision-makers of ICU patients who were mechanically ventilated for more than 48 h. INTERVENTION: None. MEASUREMENTS AND RESULTS: A group consisting of 1,123 substitute decision-makers received questionnaires; 789 were returned (70.3% response rate). Respondents were most satisfied with the frequency of communication with nurses and least satisfied with the frequency of communication with physicians. In terms of overall satisfaction with decision-making, 560 (70.9%) of the respondents were either completely or very satisfied. The majority (81.2%) of respondents preferred some form of shared decision-making process. Factors contributing the most to satisfaction with decision-making included: complete satisfaction with level of health care the patient received, completeness of information received, and feeling supported through the decision-making process. Satisfaction with decision-making varied significantly across sites. CONCLUSIONS: In this multicenter observational study, we found that most substitute decision-makers for ICU patients wanted to share decision-making responsibility with physicians and that, overall, they were satisfied with their decision-making experience. Adequate communication, feeling supported, and achieving the appropriate level of care for their family member were key determinants of satisfaction with decision-making in the ICU.

Canada↗

Critical elements in the process of decision making: a nursing perspective.

Decision making is a fundamental element of nursing work, one that is essential to understand as organizations explore cost effective ways to deliver quality health care. While the importance of decision making has been well articulated, previous descriptions of nursing work have had difficulty describing completely this cognitive component. This paper identifies critical elements within the process of nursing decision making that have not been addressed adequately within current decision making frameworks. In this exploratory research, nursing personnel described their work; qualitative content analysis was used to categorize components of nursing decision making within these descriptions. Revealed are complex nursing decisions that occur after the selection of nursing intervention, and prior to the implementation of that intervention. These decisions address the complex network of interactions involved with enactment of the nursing role, the repertoire of leadership skills such as collaboration, negotiation, and delegation required to elicit the involvement of other individuals; discretionary decisions made in the allocation of resources; priority setting; and strategizing. These findings have implications for nursing competency and quality of care, cost-effective delivery of health care, and nursing education.

Attitude of Health Personnel↗

Decision making and neuropsychiatry.

Abnormal decision making is a central feature of neuropsychiatric disorders. Recent investigations of the neural substrates underlying decision making have involved qualitative assessment of the cognition of decision making in clinical lesion studies (in patients with frontal lobe dementia) and neuropsychiatric disorders such as mania, substance abuse and personality disorders. A neural network involving the orbitofrontal cortex, ventral striatum and modulatory ascending neurotransmitter systems has been identified as having a fundamental role in decision making and in the neural basis of neuropsychiatric diseases. This network accounts for the dissociations among decision-making deficits in different clinical populations. Ultimately, a more refined and sophisticated characterization of such deficits might guide the early diagnosis and cognitive and therapeutic rehabilitation of these patients.

Journal Article↗

Women's decision-making in prenatal screening.

With serum screening (MS-AFP and hCG testing for Down's syndrome) women have to make several decisions in a limited time: whether to participate in the screening in the first place; then, if increased risk for fetal abnormality is detected, whether to have a diagnostic test, and finally, what to do if fetal abnormality is detected. The aim of this study was to examine how women themselves in an unselected population describe their decision-making in the different phases of serum screening. Women receiving a positive result from serum screening in two Finnish towns from September 1993 to March 1994 and a group of individually matched controls were invited to semistructured interviews; 45 index and 46 control women (79% of those invited) participated between their 29th and 37th weeks of gestation (mean 31 weeks). Although serum screening was most often presented as voluntary or as an option, half the women described participation as a routine or self-evident act; only one-fourth of the women described actively deciding about participation. After a positive screening result, women's reactions to diagnostic tests, and their intentions if disability would be detected, varied greatly. Most of the women actively decided about having diagnostic tests, but for 23% participation in diagnostic testing was called a self-evident act. Women's intentions regarding abortion varied from a firm decision to abort to a firm decision not to abort, and many remained ambivalent. Prenatal screening, which demands the making of several decisions in a limited time and is offered to all pregnant women as part of established maternity care, is not based on every participant's active decision-making and thus creates an ethical problem. This problem should receive special attention from those who develop, introduce and decide on new health care practices.

Abortion, Eugenic↗

[Decision making in nursing. A literature review of the manner in which nurses make a diagnosis].

In clinical practice professional nurses appear to make different judgments regarding particular nursing situations. Assuming that it is desirable that nurses, confronted with the same situation, make the same decisions, it is important to gain insight into the way decisions are made. The purpose of this literature review is to summarize what is already known about decision-making in nursing. It appears that most of the texts on decision-making in nursing are based on a general model on decision-making: the information-processing model. Factors influencing decision-making processes are discussed. Finally, an overview is given of research on decision-making in nursing.

Decision Making↗

The well-year of life as a basis for patient decision-making.

Medical decision-making requires the integration on costs, risks, and benefits of treatment. Clinical side effects and benefits are typically expressed in terms of symptoms and clinical states of diseases. Integrating probabilistic information about different categories is often difficult from both the patient's and the clinician's perspectives. We offer a General Health Policy Model that expresses the benefits and side effects of treatment within a common unit. The model takes into consideration mortality, function (morbidity), and preference for health states. In addition, the model uses probability information to describe the prognosis or likelihood of transition among states over the course of time. The output of the model is a well-year which is defined as the equivalent of a completely well-year of life. The well-year is a comprehensive expression of benefits minus side effects that may be useful for individual patient decision-making.

Activities of Daily Living↗

A survey of the decision-making needs of Canadians faced with complex health decisions.

OBJECTIVE: To describe the decision-making needs of Canadians when faced with 'complex' health decisions characterized by balancing advantages against disadvantages. Although a national report emphasized that public confidence in the health-care system depends on support for personal knowledge and decision-making, there has been no systematic investigation of the Canadian population's decision-making needs. DESIGN: Cross-sectional telephone survey using random digit dialling. PARTICIPANTS: National sample of 635 adults over 18 years of age, living in Canada. RESULTS: Forty-two percentage of eligible contacts participated. Sixty-five percent of contacts reported making 'complex' health decisions, commonly about medical or surgical treatments or birth control, and more commonly by women and by married/separated individuals. Most respondents took an active role in their decisions, often sharing the process with their partner or family. Being younger was associated with a more independent role. Physicians were more often involved in the decisions of respondents with less education. Fifty-nine percent of respondents experienced decisional conflict; more conflict was seen with those who were female and feeling uninformed about options, pressured to select one particular option, and unready or unskilled in decision-making. Less decisional conflict was seen in those who reported birth control decisions and in those who were 70 years and older. Participants used several strategies when deliberating about choices including: information gathering, clarifying their values, and seeking support and information from others. Personal counselling and printed information materials were commonly preferred methods of learning about options. 'Essential' criteria for judging satisfactory decision-making included: having sufficient knowledge about the options, outcomes, and probabilities; being clear about values; selecting and implementing a choice that agrees with personal values; and expressing satisfaction with the choice. CONCLUSIONS: Canadians, particularly women, face difficult decisions and need support and information from credible sources.

Adolescent↗

Women's misconceptions about cancer screening: implications for informed decision-making.

Informed decision-making about cancer screening requires that patients have a correct understanding of a test's purpose, benefits, and risks. Misconceptions, however, may be common. Semi-structured interviews were carried out and thematically coded using a purposive sample of 24 socioeconomically diverse white, African American, Latino and Chinese American women recruited from general medicine practices and community settings. Interviews focused on participants ideas related to cancer prevention and screening. Women expressed cancer-related beliefs characterized by inaccuracies, distortions, and over-simplifications. Many of these beliefs may go unrecognized in clinical settings yet have a profound influence on risk communication and, therefore, informed decision-making. Effective communication depends, first, on clinicians and patients sharing an accurate understanding of background concepts such as "prevention," "screening," and "cancer."

Black or African American↗

A model for physicians' therapeutic decision making.

We explored physician's cognitive processes when making therapeutic decisions in a complex situation in which more than one treatment option is acceptable. Eighteen internists were presented with three hypothetical cases of patients with coronary artery disease and were asked to explain their treatment decisions. Based on process tracing, we characterized their method of therapeutic decision making. We found that physicians use a three-stage process that we call focal composite analysis: (1) selection of a few facts (focal points) and evaluation of each fact individually with respect to treatment options; (2) reassessment of the value of the focal points with respect to each other and unification of the case; and (3) summation of the values of the focal points to make the final decision. Using this model, we predicted physicians' actual treatment decisions in 96% of the hypothetical cases. Further analysis revealed a wide variety of focal points chosen overall, with most physicians choosing different focal points in each case. Of a total of 32 focal points chosen in three cases, only two focal points were predictors of the physicians' actual treatment choices. We conclude that in the complex problem considered here physicians use a staged process of choosing and evaluating information to make therapeutic choices.

Angina Pectoris↗

Incorporating risk attitude into Markov-process decision models: importance for individual decision making.

Most decision models published in the medical literature take a risk-neutral perspective. Under risk neutrality, the utility of a gamble is equivalent to its expected value and the marginal utility of living a given unit of time is the same regardless of when it occurs. Most patients, however, are not risk-neutral. Not only does risk aversion affect decision analyses when tradeoffs between short- and long-term survival are involved, it also affects the interpretation of time-tradeoff measures of health-state utility. The proportional time tradeoff under- or overestimates the disutility of an inferior health state, depending on whether the patient is risk-seeking or risk-averse (it is unbiased if the patient is risk-neutral). The authors review how risk attitude with respect to gambles for survival duration can be incorporated into decision models using the framework of risk-adjusted quality-adjusted life years (RA-QALYs). They present a simple extension of this framework that allows RA-QALYs to be calculated for Markov-process decision models. Using a previously published Markov-process model of surgical vs expectant treatment for benign prostatic hypertrophy (BPH), they show how attitude towards risk affects the expected number of QALYs calculated by the model. In this model, under risk neutrality, surgery was the preferred option. Under mild risk aversion, expectant treatment was the preferred option. Risk attitude is an important aspect of preferences that should be incorporated into decision models where one treatment option has upfront risks of morbidity or mortality.

Aged↗

Using cost-effectiveness analysis for formulary decision making: from theory into practice.

The growth of expenditures on healthcare and pharmaceutical products is a concern to third-party payers because of the absence of market discipline (price signals that consumers face). Cost-effectiveness analysis is a method that allows third-party payers to systematically make judgements about the 'value for money' of these products. It moves beyond simple unit price comparisons of alternate interventions/products to consider the full stream of relevant cost and benefits. As formulary committees begin to adopt the systematic use of cost-effectiveness analyses to inform the debate, the exercise will move from an academic to a more practical application. This transition will require several important changes including defining the purpose of cost-effectiveness analysis, measurement of outcomes and data, format of reports, and contractual arrangements between the pharmaceutical industry and analysts. As more 'real world' experience is gained in the practical application of cost-effectiveness analysis, the quality of data will improve as will its value as an aid to decision making.

Cost-Benefit Analysis↗

Strategic decision making.

A key management function is making strategic decisions when there is competition for scarce resources. The authors report an in-depth study of decision making and the choices made by nurse executives when acquiring, distributing, and redistributing funds, information, space, and personnel. They describe successful strategies for resource allocation and present a model for analyzing strategic decisions.

Administrative Personnel↗

Group decision-making in animals.

Groups of animals often need to make communal decisions, for example about which activities to perform, when to perform them and which direction to travel in; however, little is known about how they do so. Here, we model the fitness consequences of two possible decision-making mechanisms: 'despotism' and 'democracy'. We show that under most conditions, the costs to subordinate group members, and to the group as a whole, are considerably higher for despotic than for democratic decisions. Even when the despot is the most experienced group member, it only pays other members to accept its decision when group size is small and the difference in information is large. Democratic decisions are more beneficial primarily because they tend to produce less extreme decisions, rather than because each individual has an influence on the decision per se. Our model suggests that democracy should be widespread and makes quantitative, testable predictions about group decision-making in non-humans.

Animals↗