Randomized trial of a patient decision aid for choice of surgical treatment for breast cancer.

A decision aid for the surgical treatment of early breast cancer was evaluated in a randomized controlled trial. The decision aid, a tape and workbook, includes explicit presentation of probabilities, photographs and graphics, and a values clarification exercise. Community surgeons were randomized to use the decision aid or a control pamphlet. Patients completed a questionnaire prior to using the decision aid, after reviewing it but prior to surgery, and 6 months after enrollment. There was no difference in anxiety, knowledge, or decisional regret across the 2 groups. There was a nonsignificant trend toward lower decisional conflict in the decision aid group. A subgroup of women who were initially leaning toward mastectomy or were unsure had lower decisional conflict. Although the decision aid had minimal impact on the main study outcomes, a subgroup may have benefited. Such subgroups should be identified, and appropriate decision support interventions should be developed and evaluated.

The effect of advance care planning on completion of advance directives and patient satisfaction in people with HIV/AIDS.

The effects of advance care planning are poorly understood. The purpose of this study was to evaluate the effect of an advance care planning intervention on the completion of advance directives (ADs) and patient satisfaction. A volunteer sample of persons with HIV/AIDS received advance directive documents, watched an educational video and received individual counselling on completing an advance directive during three face-to-face interviews over approximately six months. The advance care planning intervention was associated with an increase in advance directive completion rates from 16.4% to 40.7% (p = 0.001), but 23.1% of advance directives reported as completed were legally invalid. There was a trend towards decreased overall patient satisfaction with health care (p = 0.07). Advance are planning increases the rate of AD completion but many 'completed' advance directives are legally invalid. Advance care planning did not improve patient satisfaction with health care.

A new model of advance care planning: observations from people with HIV.

BACKGROUND: Although theoretical concepts from ethics and law have been applied, there is no conceptual model of advance care planning rooted in the perspective of individuals engaged in it. OBJECTIVE: To develop a conceptual model of advance care planning by examining the perspectives of individuals engaged in it. METHODS: In this qualitative research, we studied 140 individuals with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome who were engaged in advance care planning. Respondents' experience with and opinions about advance care planning were noted in interviews that were audiotaped, transcribed, and analyzed. RESULTS: The primary goal of advance care planning was to prepare for death, which entailed facing death, achieving a sense of control, and strengthening relationships. CONCLUSIONS: We have developed a conceptual model of advance care planning rooted in the perspectives of individuals engaged in it. The model has implications for theory, research, and practice regarding end-of-life care.

Reconceptualizing advance care planning from the patient's perspective.

BACKGROUND: Traditional academic assumptions about advance care planning (ACP) include the following: (1) the purpose of ACP is preparing for incapacity; (2) ACP is based on the ethical principle of autonomy and the exercise of control; (3) the focus of ACP is completing written advance directive forms; and (4) ACP occurs within the context of the physician-patient relationship. These assumptions about ACP have never been empirically validated. OBJECTIVE: To examine the traditional academic assumptions by exploring ACP from the perspective of patients actively participating in the planning process. METHODS: Forty-eight patients (30 men and 18 women with a mean age of 48.3 years) who were undergoing hemodialysis were interviewed 6 months after receiving an advance directive form. Their experience of ACP was noted in interviews that were audiotaped, transcribed, and analyzed. RESULTS: The participants said that their purpose in ACP was to prepare for death and dying, and their underlying goals included the exercise of control and an attempt to relieve burdens placed on loved ones. Advance care planning was viewed as a social process, and completing a written advance directive form was often regarded as unnecessary. Participants often involved close loved ones, but physicians infrequently. CONCLUSIONS: The traditional academic assumptions are not fully supported from the perspective of patients involved in ACP. The patients we interviewed stated that (1) the purpose of ACP is not only preparing for incapacity but also preparing for death; (2) ACP is not based solely on autonomy and the exercise of control, but also on personal relationships and relieving burdens placed on others; (3) the focus of ACP is not only on completing written advance directive forms but also on the social process; and (4) ACP does not occur solely within the context of the physician-patient relationship but also within relationships with close loved ones.

The HIV-specific advance directive.

OBJECTIVE: To determine whether persons living with HIV find a disease-specific advance directive more acceptable than a generic directive. DESIGN: Randomized clinical trial. SETTING: HIV consumer organization and hospital-based HIV clinic. PARTICIPANTS: Volunteer sample of persons with HIV. INTERVENTIONS: The disease-specific HIV Living Will, the generic Centre for Bioethics Living Will, or both. MEASUREMENTS AND MAIN RESULTS: Of 101 participants who received both advance directives, 78 (77.2%) preferred the disease-specific HIV Living Will and 23 (22.8%) preferred the generic Centre for Bioethics Living Will (p < .001). Most participants who preferred the HIV Living Will did so because it was more specific or relevant to their situation. CONCLUSIONS: Persons living with HIV prefer a disease-specific to a generic advance directive. They should be offered a disease-specific advance directive. Our findings should also encourage investigators to develop and evaluate disease-specific advance directives in other clinical settings.

The relationship between cardiac functional capacity and patients' symptom-specific utilities for angina: some findings and methodologic lessons.

Forty-one angina patients with coronary disease were interviewed to examine the correlation between prespecified and individualized weights for disease-specific measures of the effects of angina on the patients' well-being. Modifications of the Canadian Cardiovascular Society (CCS) scale for angina and the Duke Activity Specific Index (DASI) were used to rate functional capacity with prespecified items. Disease-specific utilities based on descriptions of functional status were obtained directly, and again indirectly with different anchoring conditions to control for noncardiac comorbidity. Correlations between the functional-capacity measures and the derived utilities were not strong, ranging from -0.25 (p > 0.1) to -0.35 (p = 0.02). Correlation between the two prespecified measures was higher (r = -0.51 or -0.69, both p < 0.01, for DASI versus CCS graded from walking and stair-climbing, respectively). The direct and indirect disease-specific utility scores were similar (r = 0.92, p < 0.01). The method described provides an approach to measuring disease-specific utilities by adapting existing scales for use in a standard gamble. It confirms that prespecified functional status scores inconsistently reflect patients' valuations of functional states. Further investigation should address whether the observed null effect of comorbidity on disease-specific utilities arose from inadequate coverage of the comorbidity issues in patient interviews or from lack of power given the small size of the feasibility study.

Life-sustaining treatment preferences of hemodialysis patients: implications for advance directives.

The purpose of this study was to describe the life-sustaining treatment preferences of dialysis patients and to compare the acceptability of two generic and a disease-specific advance directive (AD). Of 532 potentially eligible hemodialysis patients, 95 (17.9%) participated in the study. These patients completed two generic (the Centre for Bioethics Living Will and the Medical Directive) and one disease-specific (the Dialysis Living Will) AD in a randomized cross-over trial. Treatment preferences were measured by using the Centre for Bioethics Living Will. Acceptability of the AD was measured by using a 13-item advance directive acceptability questionnaire (ADAQ) for each AD, and the advance directive choice questionnaire (ADCQ) to elicit participants' preferred AD. Twenty-five percent of the participants wanted to continue dialysis in case of severe stroke, 19% in severe dementia, and 14% in permanent coma. Averaged across treatments, proportions of participants wanting treatment in various health states were: current health (86%), mild stroke (84%), moderate stroke (60%), severe stroke (21%), mild dementia (78%), moderate dementia (51%), severe dementia (14%), terminal illness (41%), and permanent coma (10%). Averaged across health states, proportions of participants wanting various types of treatment were: dialysis (58%), antibiotics (53%), transfusion (53%), surgery (48%), cardiopulmonary resuscitation (48%), respirator (47%), and tube feeding (41%). Mean ADAQ scores were: Dialysis Living Will, 71%; Centre for Bioethics Living Will, 70%; and Medical Directive, 60% (F = 8.27, P < 0.001 (repeat measures analysis of variance); the Dialysis Living Will and Centre for Bioethics Living Will scored significantly higher than the Medical Directive). The proportion of participants who said they would choose to complete each AD was: Dialysis Living Will, 28%; Centre for Bioethics Living Will, 38%; Medical Directive, 31%; and unsure, 3% (chi 2 = 1.465, df = 2, P = 0.48). In conclusion, twenty-five percent or less of hemodialysis patients want to continue dialysis in three specific health states: severe stroke, severe dementia, and permanent coma. Health states and illness severity, far more than treatment descriptions, influence preferences. Dialysis patients should be offered a generic AD, and some generic AD are more acceptable than others. Only a minority of dialysis patients will complete any AD, but the completion of written AD forms is only one element in the process of advance care planning.

Presenting clinical trial information: a comparison of methods.

The study objective was to assess the relative effects of 2 approaches to teaching about a clinical trial, in terms of patients' satisfaction, information understanding, and whether or not they would enter such a trial. One hundred patients receiving radiation therapy for a variety of cancer diagnoses were randomized to receive information about a hypothetical trial, either by audio tape or interactive computer program. A day later, information understanding was assessed. One week later, method satisfaction and whether respondents would enter such a trial were assessed. There were no differences in understanding or satisfaction. Members of the computer program group tended to report a more positive attitude towards trial entry (chi 2 = 4.0; 1 df; P = 0.05). Overall, refusers tended to be women with higher understanding scores. The results suggest that teaching with interactive components might not adversely affect trial accrual. Further work involving an actual trial entry decision is merited; the sex of the respondent should be controlled in designing this future work.

Cancer patients' decision making and trial-entry preferences: the effects of "framing" information about short-term toxicity and long-term survival.

The study purpose was to determine whether the framing of treatment information influenced patients' reported preferences for participating in treatment decision making and for trial entry. Ninety cancer patients read either neutrally-, positively-, or negatively-framed information about a chemotherapeutic treatment, then indicated their preferences for participating in the treatment decision, and whether they would participate in a clinical trial incorporating this protocol. There was no difference across information groups in preferences for participating in treatment decision making or willingness to enter such a clinical trial. Preference for participation in treatment decision making was significantly related to age (t = 2.54; p = 0.022), sex (x2 = 3.89; p = 0.05), and education (t = 2.54; p = 0.018); trial entry preferences were unrelated to these demographic variables. These results imply that, in this clinical context, attitudes towards participation in treatment decision making may be associated with characteristics of the patient, and attitudes towards trial entry may be dependent upon the clinical characteristics of a particular trial, but neither set of attitudes is influenced by the framing of protocol information.

Do patients' evaluations of a future health state change when they actually enter that state?

Fundamental to using utilities for future health states for clinical decision analysis is the assumption that the utilities are stable. The purpose of this study was to determine if cancer patients' prior evaluations of a treatment-induced health state remain stable when they later experience that state. Before a four-week course of radiation therapy, 66 laryngeal cancer patients evaluated three common treatment-induced outcome scenarios (mild/moderate/severe) using rating scales and the time trade-off, and provided self-assessments of voice symptoms, voice function, and general health. Evaluations and self-assessments were repeated at the end of therapy, and respondents indicated which outcome scenario described their actual end-of-therapy state. Twenty-four patients identified the mild scenario as their outcome state, 36 the moderate, and 6 the severe. No across-time differences in evaluations were detected, although significant (P < .0001) downward shifts in scores for voice symptoms (t = 5.67), voice function (t = 5.10), and general health (t = 6.69) indicated that actual change in health status had occurred. These results imply that patients' evaluations of imagined short-term health states encountered during radiation therapy for laryngeal cancer remain consistent when those states are experienced at a later time. The design of this project provides a model for determining if this consistency appears in other clinical situations.

Cancer patients' evaluations of their current health states: the influences of expectations, comparisons, actual health status, and mood.

A study was done to determine the extent to which patients' subjective evaluations of their current health are determined by their expectations, their actual health, and how they compare themselves with others. At the initiation of radiation therapy, 61 laryngeal cancer patients described the health status they expected at the end of therapy, using standardized and individualized dimensions. Objective summative scores were derived for these descriptions. At the end of therapy, these respondents described their current health status and the status they believed others their age were experiencing, on the same dimensions, and objective summative scores were derived for these actual and social comparison states. Rating scales and standard gambles were used to obtain values and utilities ("subjective evaluations") for current health at the end of therapy. Multiple linear regression was used to determine the extent to which variation in the subjective evaluations was explained by the objective scores for actual, expected, and social comparison states, under these different methodologic conditions. Actual health state was a consistently significant predictor. Most variance was explained in the model using individualized dimensions and value scores (r2 = 46.0%). Further investigation is needed to determine whether differences in the amounts of variance explained are due to aversion to gambling, dimension salience, order effects, or respondent fatigue.

Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation.

Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms. These differences, if they exist, have implications for the process of obtaining informed consent and for the generalization of the results of a clinical trial. This paper describes the development and initial application of methods designed to detect such differences. Developmental work involved creating an inventory of instruments designed to determine patients' attitudes towards participating in treatment decision making, permitting random selection of treatment, and undertaking the risks and benefits associated with the various treatments in a trial. Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma, seeking responses to these measures from 60 non-eligible colorectal cancer patients, then determining whether those who would agree to trial entry differed systematically on these measures from those who indicated that they would refuse such a trial. Twenty-five of the respondents reported that, if faced with the actual decision, they would agree to trial entry: 35 would refuse. Refusers demanded more participation in decision making (Chi-square; P = 0.01) and a greater increment in treatment benefit (t-test; P = 0.0001). Twenty-two of the 35 refusers reported aversion to randomization as their primary reason for trial refusal. Since their particular content can be modified, these measures may be applicable to all clinical trials. They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trials results.