Biomedical subjects
D J Mazur
Publications and source records attributed to D J Mazur.
Law and ethics.
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Law and ethics: the physician as learned intermediary and when a clinical trial is in a developing country: the protection of human subjects.
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Informed consent: court viewpoints and medical decision making.
Twenty-five years of appellate court decisions about informed consent in three influential states were examined to address four issues: the criteria used to define adequate informed consent; trends in court decisions; parallels between court decision making and decision analysis; the contribution of decision analytic concepts to defining "reasonable" medical informed consent. Court standards have evolved in three phases: the "medical community" standard before 1972, the "reasonable person" standard since 1972, and recent inroads toward developing an "individual preference" standard. The latter two standards form the current basis for deciding whether a patient has been adequately informed. Decision analysis offers a framework for communication about medical outcomes and probabilities, and methods for assessing preferences. Jurists and physicians should consider whether the legal system should adopt a decision analytic perspective in the doctrine of informed consent. Researchers should address issues raised by use of decision analysis for communication between the physician and the patient.
Treatment preferences of patients and physicians: influences of summary data when framing effects are controlled.
The presentation of efficacy data influences preferences for treatment options. To determine how the amount of data provided to patients influenced patient decision making after framing and labeling effects were controlled, patients and physicians were presented results of two alternative treatments for an unidentified serious medical condition, derived from summary data of lung cancer treatment after surgery (better long-term survival) or radiation therapy (better short-term survival). These data are the same as used in previous studies of framing. When summary data at one month, one year, and five years were presented in terms of both survival and mortality, patients preferred the option that would be expected if only mortality data had been presented. When more detailed data were presented (data at six discrete time points), both patients and physicians preferred the option associated with a survival frame influence in previous studies. Thus, once framing influences are controlled, preference changes can be influenced by another attribute of summary data: the amount of data presented.
Judicial and legislative viewpoints on physician misestimation of patient dysutilities: a problem for decision analysts.
Appellate courts, state legislatures, and ethicists have recently (post-1972) been interested-through the evolving court doctrine of informed consent-in patient-physician joint decision making. Yet these professional groups' approaches differ markedly from that of decision analysis, failing to include an explicit role for patients' rational processing of information in informed consent. In addition, these groups charge that decision analysts are misestimating patient dysutilities. This paper examines three issues: 1) in what sense(s), if any, is decision-analytic work in individualized medical decision making misestimating patient dysutilities, 2) if this misestimation is real, whether it is an example of the normative-descriptive tensions that exist in medical decision making, and 3) in what ways do the relationships between decision-analytic and judicial decision making change when informed consent is viewed in terms of contract law as opposed to tort law. This paper argues that a key link dividing these professional groups is the differing weights given to the "value of information" by decision-analytic vs. non-decision-analytic frameworks.
Verbal expressions of probability in informed consent litigation.
Informed consent litigation provides a forum in which probabilistic evidence is elicited from physicians as parties or as expert witnesses. The authors reviewed over 450 medical informed consent opinions reported by both trial and appellate courts in all 50 states over 40 years to determine 1) the extent to which verbal expressions of probability were used by testifying physicians to characterize the risks of medical procedures; 2) when such expressions were used, whether consistent numeric interpretations of the terms were being applied by the physicians; 3) whether the choice of expression was influenced by the severity of the consequences associated with the particular risk; and 4) whether the use of such terms was correlated with trial outcomes, inasmuch as the duty to disclose a risk is said to increase with the magnitude of the risk and probability is one measure of such magnitude. It was found that subjective verbal expressions of probability are used in the litigation setting, and that such expressions represent broad ranges of numeric probabilities. There was some correlation between the expression and the represented numeric probabilities. In general, expressions such as "extremely low" and "low" corresponded to probabilities lower than those represented by terms such as "high" and "very high." Further, verbal expressions appeared to be influenced by the severity of the consequences associated with the risks, but whether this increases or decreases the ambiguity of verbal expressions in the communication process warrants further research. The authors suggest a syntax of verbal expressions of probability as a means to reduce the numeric ambiguity of these terms.
Patients' and physicians' interpretations of graphic data displays.
To assess how patients' and physicians' treatment preferences are influenced by graphic data displays (five-year survival curves), a cross-sectional survey of patients, physicians, and medical students was done in a university-based Department of Veterans Affairs Medical Center. Participants in the study were 119 patients seen in a general medicine clinic, 43 physicians, and 67 medical students. Three five-year survival graphs were used. Each graph contained survival curves for two alternative unidentified treatments for an unidentified medical condition. Graph 1 was a baseline graph used in previous studies of framing effects. Graph 2 contained one survival curve having an area under the curve that was 24% greater than that in graph 1. Graph 3 contained one survival curve that had an area under the curve that was 42% greater than that in graph 1. Respondents were asked to indicate which treatment they preferred for each graph and which aspects of the five-year survival curves most influenced their choices. Respondents did not receive numerical data about the difference between the areas under the two curves. Most patients did not change their preferences across the three graphs. A significantly larger (p < or = 0.0001) proportion of physicians and medical students than of patients changed their preferences across the three graphs.(ABSTRACT TRUNCATED AT 250 WORDS)
The effect of physician's explanations on patients' treatment preferences: five-year survival data.
OBJECTIVE: To evaluate the influence of physicians' explanations on patients' choices. SETTING: A university-based Department of Veterans Affairs Medical Center. PARTICIPANTS: 136 patients seen in a continuity-care general medicine clinic. MEASUREMENTS AND RESULTS: Patients were randomized to two groups [Limited Explanation (LE) and Extensive Explanation (EE)] and asked to choose between two alternative treatments (differing in short-term vs long-term survival benefits) for an unidentified medical condition, based on the information given in the explanations. LE consisted of a brief orientation to graphs summarizing the treatment results, while EE consisted of a detailed verbal description of the graphs. Significantly (p < 0.001) more patients receiving EE changed their preferences across the three pairs of five-year survival curves, compared with patients receiving LE. Of the patients receiving EE, 57% reported either medium-term (year 0-to-intercept or intercept-to-year 5) data or the average life expectancy for the five-year period contained in the curves (ALE-5) as most influencing their decision making; whereas 78% of patients receiving LE reported only endpoint (year 0 or year 5) data as most influencing their preferences. CONCLUSIONS: The patients' treatment preferences for long-term vs short-term survival benefits were influenced by the amounts of verbal explanation provided to them about five-year survival graphs summarizing treatment results. The patients appeared to minimize the importance of medium-range data when those data were not specifically pointed out to them.
The influence of physician explanations on patient preferences about future health-care states.
OBJECTIVE: To determine the influence of alternative explanations by physicians of the purpose of a medical intervention (intubation and ventilatory support, IVS) on three types of patient preferences: desire for IVS, the length of time patients would find IVS acceptable, and the minimum probability of a good medical outcome patients would require before assenting to continued support with IVS. METHODS: Structured interviews were conducted with patients followed in a continuity care general medicine clinic at the Department of Veterans Affairs Medical Center, Portland, Oregon. Patients were asked to consider whether they would accept IVS at a future time. Patients were randomly assigned to one of two explanation conditions that differed in terms of their future medical contexts, that is, the degrees of specification of the nature of the medical condition patients were asked to consider. The general-explanation group was asked to consider the future medical context of " an unspecified medical condition"; the specific-explanation group was asked to consider the future medical context of "a severe pneumonia." Patients were asked three questions: 1) Would you accept IVS (yes or no)? 2) How long would you allow your physician to continue IVS?; and 3) After being on IVS for 2-3 days, what would be the minimum chance of recovery from the condition you would require before agreeing to continued IVS? "Chance of recovery" was defined for both groups as the probability that the patient would be able to leave the hospital and be able to take care of activities of daily living unassisted with minimal change in his or her mental state from the pre-hospitalization status. RESULTS: Of 186 patients (mean age = 66.5 years; mean education = 12.7 years), 97 received the general explanation and 89 received the specific explanation about a severe pneumonia. Significantly fewer (p = 0.03) patients receiving the general explanation wanted physicians to intervene with IVS (general 94% vs specific 100%). Patients receiving the general explanation were willing to accept significantly fewer (p = 0.009) days of intubation (general 65 days vs specific 96 days). Significantly fewer (p < 0.0001) patients receiving the general explanation wanted physicians to continue IVS when the probability of a successful outcome was less than 50% (general 30% vs specific 64%). CONCLUSION: Physician explanations--based on general (unspecified medical condition) vs specific (severe pneumonia) explanations--have a marked influence on the duration of IVS patients would permit and the probability of a good outcome required to continue IVS.
Judgmental psychology, law, and ethics.
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Judgmental psychology, law, and ethics.
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How patients' preferences for risk information influence treatment choice in a case of high risk and high therapeutic uncertainty: asymptomatic localized prostate cancer.
To assess how patients' preferences for non-numerical risk information are related to their tendency to choose early surgical treatment for asymptomatic gland-confined prostate cancer (a choice with high risk and high therapeutic uncertainty), the authors conducted a cross-sectional study of 228 patients receiving continuing care in a general medicine clinic. After being provided with three data disclosures related to the treatment decision, subjects were given a choice between surgery-now and watchful waiting. Data about surgical complications were presented in numerical format. The subjects were also asked whether they preferred communication with their physician about the chance (probability) of adverse outcomes-related to management strategies-in terms of words (such as possible or probable) or numbers (such as percentages). Of the 226 patients who chose either surgery-now or watchful waiting, 71.2% preferred risk information in terms of words only or numbers only: 44% words only, and 56% numbers only. Younger patients (OR = 1.06 per year; CI = 1.02-1.10, p = 0.0008) and those wanting risk communication in terms of words only (OR = 2.41; CI = 1.24-4.70, p = 0.01) tended to prefer surgery-now over watchful waiting as the management strategy for asymptomatic gland-confined prostate carcinoma. The authors conclude that there is a significant association between patients' preferences for risk communication with their physicians in terms of words only and a tendency to prefer early surgical intervention for prostate cancer when surgical risk data are provided numerically.
Law and ethics (future risk of cancer).
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Law and ethics.
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Death notification: legal and ethical issues.
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Patient preferences for management of localized prostate cancer.
We designed this study to determine whether patients with early localized prostate cancer prefer surgical intervention over watchful waiting, which aspects of the 2 management strategies influence patient preferences, and whether there are patient characteristics that predict their preferences for 1 strategy over the other. Structured interviews were used with 140 male patients seen consecutively at a university-based Department of Veterans Affairs Medical Center outpatient clinic. The mean age of the patients was 66.3 years. Of the 140 patients, 53% preferred surgical treatment, 42% preferred observation, 4% preferred that their physician make the decision, and 1% preferred radiotherapy. Of 74 patients selecting surgical intervention, 92% (68) reported that the possibility of complete tumor removal was the strongest factor influencing their decision. Of those selecting observation, 80% (47/59) reported being most influenced by the complications of an operation. Older patients were significantly (P < .002) more likely to prefer expectant management. We conclude that tumor excision is an important factor influencing patient preferences for treatment, irrespective of survival benefits. This factor should be considered when designing approaches to providing information to patients about alternative treatments.
Law and ethics. Law and sociology of knowledge (court-compelled disclosure of research data).
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