Speaking of research advance directives: planning for future research participation.

OBJECTIVE: To examine one model of research advance directive as a possible way to reduce the mismatch between patient and proxy choices and also to learn more about how patients with mild to moderate dementia may want to keep decision making or cede it to their proxies in the future. METHODS: Separate interviews were conducted with 149 dyads of dementia patients and family proxies about future enrollment in five types of research. Subsequent joint interviews were conducted with 69 of those dyads to discuss their separately articulated decisions and ask whether the patient prefers future enrollment decisions to be made as he or she directs today or as the proxy deems best in the future. RESULTS: Patients chose to cede future decision making to their proxies in 82.9% of the trials. Patients ceded decisions to their proxies in 80.7% of those trials about which the dyad had given opposite answers (n = 74, 49.7%). Patients who had expressed discomfort about the prospect of the proxy making an enrollment decision in a trial (n = 49, 32.9%) ceded decision making to their proxies in 45.7% of those trials. CONCLUSIONS: Both patients and proxies were willing to discuss future research enrollment in the context of an advance directive for research. Such a document may be helpful to proxies and researchers in the future to judge the types of research and associated risks patients are willing to enroll in. Although most patients willingly cede future decisions to their proxies, a sizeable minority do not wish to do so.

Better health while you wait: a controlled trial of a computer-based intervention for screening and health promotion in the emergency department.

STUDY OBJECTIVE: We evaluate a computer-based intervention for screening and health promotion in the emergency department and determine its effect on patient recall of health advice. METHODS: This controlled clinical trial, with alternating assignment of patients to a computer intervention (prevention group) or usual care, was conducted in a university hospital ED. The study group consisted of 542 adult patients with nonurgent conditions. The study intervention was a self-administered computer survey generating individualized health information. Outcome measures were (1) patient willingness to take a computerized health risk assessment, (2) disclosure of behavioral risk factors, (3) requests for health information, and (4) remembered health advice. RESULTS: Eighty-nine percent (470/542) of eligible patients participated. Ninety percent were black. Eighty-five percent (210/248) of patients in the prevention group disclosed 1 or more major behavioral risk factors including current smoking (79/248; 32%), untreated hypertension (28/248; 13%), problem drinking (46/248; 19%), use of street drugs (33/248; 13%), major depression (87/248; 35%), unsafe sexual behavior (84/248; 33%), and several other injury-prone behaviors. Ninety-five percent of patients in the prevention group requested health information. On follow-up at 1 week, 62% (133/216) of the prevention group patients compared with 27% (48/180) of the control subjects remembered receiving advice on what they could do to improve their health (relative risk 2.3, 95% confidence interval 1.77 to 3.01). CONCLUSION: Using a self-administered computer-based health risk assessment, the majority of patients in our urban ED disclosed important health risks and requested information. They were more likely than a control group to remember receiving advice on what they could do to improve their health. Computer methodology may enable physicians to use patient waiting time for health promotion and to target at-risk patients for specific interventions.

Would physicians override a do-not-resuscitate order when a cardiac arrest is iatrogenic?

OBJECTIVE: To assess whether physicians would be more likely to override a do-not-resuscitate (DNR) order when a hypothetical cardiac arrest is iatrogenic. DESIGN: Mailed survey of 358 practicing physicians. SETTING: A university-affiliated community teaching hospital. PARTICIPANTS: Of 358 physicians surveyed, 285 (80%) responded. MEASUREMENTS AND MAIN RESULTS: Each survey included three case descriptions in which a patient negotiates a DNR order, and then suffers a cardiac arrest. The arrests were caused by the patient's underlying disease, by an unexpected complication of treatment, and by the physician's error. Physicians were asked to rate the likelihood that they would attempt cardiopulmonary resuscitation for each case description. Physicians indicated that they would be unlikely to override a DNR order when the arrest was caused by the patient's underlying disease (mean score 2.55 on a scale from 1 "certainly would not" to 7 "certainly would"). Physicians reported they would be much more likely to resuscitate when the arrest was due to a complication of treatment (5.24 vs 2. 55; difference 95% confidence interval [CI] 2.44, 2.91; p <.001), and that they would be even more likely to resuscitate when the arrest was due to physician error (6.32 vs 5.24; difference 95% CI 0. 88, 1.20; p <.001). Eight percent, 29%, and 69% of physicians, respectively, said that they "certainly would" resuscitate in these three vignettes (p <.001). CONCLUSIONS: Physicians may believe that DNR orders do not apply to iatrogenic cardiac arrests and that patients do not consider the possibility of an iatrogenic arrest when they negotiate a DNR order. Physicians may also believe that there is a greater obligation to treat when an illness is iatrogenic, and particularly when an illness results from the physician's error. This response to iatrogenic cardiac arrests, and its possible generalization to other iatrogenic complications, deserves further consideration and discussion.

What is the quality of the reporting of research ethics in publications of nursing home research?

OBJECTIVE: To assess the quality of reporting of research ethics in published clinical research that involves a particularly vulnerable population: nursing home residents. DESIGN: A structured review of publications researched from 1992 to 1996 that involve nursing home residents. The review instrument assessed each publication's compliance with four common standards for research that involves nursing home residents or the cognitively impaired: justification of the use of nursing home residents, Institutional Review Board (IRB) review, nursing home committee review, and informed consent. For each publication, these results were summed into a quality score. The research ethics requirements contained in the journals' instructions for authors that corresponded with each publication were categorized in order to compare whether an association exists between the average quality score for each category and the detail of its research ethics instructions. RESULTS: Forty-five publications were identified. The four quality measures of research ethics showed that (1) all 45 publications reported justification of use of nursing home residents, (2) 36 publications reported that informed consent was obtained or waived, (3) 18 publications reported IRB review, and (4) six publications reported nursing home committee review. Of the 35 publications reporting informed consent was obtained, 16 reported assessing subjects' decisional capacity, and 24 reported whether cognitively impaired subjects were included (19) or excluded (5). The research ethics requirements of each publication's instructions for authors ranked it in one of four categories: (A) None (9); (B) Less than "Uniform Requirements (UR) for Manuscripts Submitted to Biomedical Journals" (7); (C) UR (24); (D) UR plus Additional Instructions (5). A positive association exists between the detail of a research ethics instructions category and the average research ethics quality score for each category (Kruskal-Wallis chi2 = 11.2, P = .01). That is, the more detailed the instructions, the greater the quality score. CONCLUSION: In publications of research that involves nursing home residents, basic standards of research ethics are not typically reported. However, the positive association between research ethics instructions category and research ethics quality score suggests that a journal's instructions for authors or other features of peer review and editing can affect the quality of reporting research ethics.

Dialysis decision making in Canada, the United Kingdom, and the United States.

This study was designed to determine the extent to which differences in criteria for dialysis patient selection and availability of financial resources cause the wide variation in acceptance rates for dialysis in Canada, the United Kingdom, and the United States. We also sought to determine whether there is agreement among nephrologists in the three countries on which patients should not be offered dialysis. We used a cross-sectional survey of all members of the Canadian Society of Nephrology and the Renal Association of Great Britain, and a randomized sample of 800 members of the American Society of Nephrology. Five case vignettes were presented asking for yes/no decisions on offering or not offering dialysis, together with ranking of factors considered important. We also inquired about dialysis resources and physician demographics. We compared responses by country. More nephrologists from the United Kingdom returned responses (83%) than Canadian (53%) or American (36%) nephrologists. American nephrologists offered dialysis more than Canadian or British nephrologists (three of five cases; P < 0.04 to P < 0.001) and ranked patient/family wishes (three of five cases; P < 0.057 to P < 0.0001) and fear of lawsuit (P < 0.04 to P = 0.0012) higher than British or Canadian nephrologists. Canadian and British nephrologists reported their perception of patients' quality of life as a reason to provide (P = 0.0019) or not provide (P = 0.068 to P = 0.0026) dialysis more often than their American counterparts. Despite these differences, nephrologists from each country did not differ by more than 30% on any decision and ranked factors almost identically. Ten percent and 12% of Canadian and British nephrologists, respectively, but only 2% of American nephrologists, reported refusing dialysis due to lack of resources (P < 0.0001). We conclude that the wide variation in dialysis acceptance rates in the three countries is somewhat influenced by differences in patient selection criteria and withholding of dialysis by nephrologists based on financial constraints, but that other factors, such as differences in rates of patient nonreferral for dialysis, contribute more significantly to the variation. Generally agreed on practice guidelines for dialysis patient selection appear possible.

Genes or gestation? Attitudes of women and men about biologic ties to children.

In light of the different reproductive roles of men and women, our objective was to ascertain whether men and women attach different significance to genetic, as distinct from gestational, ties to offspring. Surveys returned by 106 men and women of reproductive age in the general clinic waiting area of the University of Chicago Health Service showed that 71.1% of women and 62.9% of men would seek medical assistance if necessary to have a biologically related child. When women were asked whether they would choose the genetic tie or the gestational tie if both were not possible, 48.6% chose the genetic tie, and 51.4% chose the gestational tie. When men were asked which relationship they preferred for their partner, 73.5% chose the genetic tie, and 26.5% chose the gestational tie. Neither marital status nor experience of child-birth (for oneself or one's partner) were predictive of preferences. Our data suggest that gender differences as well as individual differences need to be addressed in counseling individuals and couples.

Patients with amyotrophic lateral sclerosis receiving long-term mechanical ventilation. Advance care planning and outcomes.

OBJECTIVE: To examine advance care planning and outcomes of patients with amyotrophic lateral sclerosis (ALS) receiving long-term mechanical ventilation (LTMV). DESIGN: Case series. SETTING: Population-based study in homes and chronic care facilities in four states, and Home Ventilator Program of California Kaiser Permanente. PATIENTS: Seventy-five ALS patients receiving LTMV were identified; 11 died prior to interview, and 6 were totally locked in; 50 of 58 (86%) who were able to communicate consented to structured interviews, of whom 36 lived at home and 14 in an institution. RESULTS: Thirty-eight patients (76%) had completed advance directives, and 96% wanted them. Thirty-eight patients wished to stop LTMV in certain circumstances, of whom 30 had completed advance directives. Those who had completed advance directives were more likely to have communicated their preference, to stop LTMV to family and physician than those who had not (76 vs 29%; p = 0.05). Patients living at home rated their quality of life on a 10-point scale better than those in an institution (7.2 vs 5.6; p = 0.0052), and their yearly expenses were less ($136,560 vs $366,852; p = 0.0018). CONCLUSIONS: Most ALS patients receiving LTMV would want to stop it under certain circumstances, and the process of advance care planning enhances communication of patient preferences to family and physicians. Home-based LTMV is less costly and associated with greater patient satisfaction.

Do actions reported by physicians in training conflict with consensus guidelines on ethics?

OBJECTIVE: To assess the extent to which actions reported by internal medicine trainees conflict with published guidelines on ethics. METHODS: A confidential survey was sent to a random sample (N = 1000) of associate members of the American College of Physicians (ACP). Questions were asked about ethical decision making in areas addressed by the guidelines in the ACP Ethics Manual. Quoted manual guidelines were provided, followed by 55 yes or no questions, such that a yes answer represented an action that conflicted with a guideline. There were two follow-up mailings to nonresponders. RESULTS: Forty percent (n = 397) completed the questionnaire; 17% indicated they were aware of the guidelines on ethics. On average, associates responded yes to 16% of questions where a yes response indicated they have acted outside guidelines on ethics one or more times. The mean number of responses (n = 55) that conflicted with a guideline was 7.6 per person (SD, 4.7 responses; range, 0 to 33 responses). Ninety-eight percent of respondents reported actions falling outside a guideline one or more times and 80% did so four or more times. The most frequently reported reason (965/3219 [30%]) from a list of four choices for acting outside a guideline was "I was aware of the guideline, but this did not represent an ethical dilemma to me." CONCLUSIONS: Few responding ACP associates indicated awareness of the ACP guidelines on ethics. Physicians in training nevertheless reported acting according to the presented guidelines most of the time, although nearly all respondents acted outside a guideline at least once, and some did so many times. Reported behaviors were sometimes inconsistent with consensus ethical standards that apply to internists. Physicians in training need to know more about ethical standards that apply to their own practice and should be aware when their actions deviate from ethical norms. Before acting outside guidelines on ethics, trainees should discuss their conflicts with others, such as attending physicians, clinical ethicists, or hospital ethics committees.

Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients.

Postmarketing research, often called phase IV trials, is intended to familiarise doctors and patients with newly approved drugs. La Puma and colleagues, in Chicago, studied doctors' and patients' attitudes to whether doctors should receive payment for taking part in such research. We asked for commentaries on their findings from four ethical experts, who put the study in a British context, present the views of patients, and examine some methodological assumptions.

Variation in the attitudes of dialysis unit medical directors toward decisions to withhold and withdraw dialysis.

Increasingly, physicians who treat patients with renal failure are deciding with patients and families whether to withhold or withdraw dialysis. These decisions as well as those concerning whether medical directors of dialysis units felt prepared to make them were studied using three hypothetical scenarios. A questionnaire survey of 524 physician medical directors of adult chronic dialysis units throughout the United States was conducted. They were asked about decisions to withdraw dialysis from a competent patient and a patient with severe dementia, about decisions to withhold dialysis from a permanently unconscious patient, and also about their use of ethics committees to reach these decisions. Three hundred eighteen (61%) responded. Most, 92%, indicated that their units would usually honor a competent patient's request to stop dialysis. There was less agreement about whether to start dialysis in permanently unconscious patients; 83% would withhold dialysis, and 17% would provide it. There was the least agreement about continuing dialysis in patients with dementia; 32% would stop dialysis, and 68% would continue it. Ninety-four percent of medical directors reported that they felt prepared to decide about withholding and withdrawing dialysis. Eighty percent said they might consult a Network ethics committee for difficult decisions. Almost all medical directors of dialysis units believe that they are prepared to make decisions to withhold and withdraw dialysis. Nevertheless, this study revealed significant variation in their attitudes toward these decisions. Practice guidelines and consultation with ethics committees might assist dialysis unit medical directors in making these decisions more uniformly and in a way that promotes patient benefit.

Home ventilation for amyotrophic lateral sclerosis patients: outcomes, costs, and patient, family, and physician attitudes.

We conducted this study to better inform amyotrophic lateral sclerosis (ALS) patients about home ventilation and to assist them in decision-making. We gathered data on the prevalence of ALS patients on home ventilation in northern Illinois and the percentage who chose it, and we asked identified subjects, their families, and physicians for their attitudes toward home ventilation. Fewer than 10% of ALS patients had chosen home ventilation, and fewer than 5% were still on it. Seventeen patients (90%) were glad to have chosen home ventilation and would choose it again. Family caregivers reported major burdens, and only half would choose it for themselves. The mean yearly cost of home ventilation was $153,252. Home ventilation is effective for ALS patients had desired by the small number who undergo it, but it imposes significant burdens on families.

Can patients use an automated questionnaire to define their current health status?

Patient management decisions rarely incorporate standardized health status assessments, since accurate and reliable measures are difficult and expensive to obtain. In prior research with various methods for obtaining health data from patients, it was found that physicians' acceptance of a method was improved if it provided an individualized printout. It was also determined that patients will readily complete a health status questionnaire on a computer when the computer does not look like a computer. Patients' acceptance was greatest when they were presented with a single line of large, pressure-sensitive buttons with which they could respond to questions about their health histories. Using such an instrument, the HealthQuiz, the current study found the same discrepancy rate (3%) between patients' responses to health questions presented on HealthQuiz and during interview as between their responses to questions asked during two separate interviews. Further, to ascertain health status, rules determined by an expert panel were applied to patients' responses to health questions presented on the HealthQuiz screen. It was found that the numerical health status derived from answers to the automated presentation of questions was similar to numerical health status derived by a physician after a patient-physician interview.

Community hospital ethics consultation: evaluation and comparison with a university hospital service.

BACKGROUND: Ethics consultants may improve patient care by responding to physician requests for assistance with problems they identify as ethical issues. OBJECTIVE: To examine three aspects of ethics consultation: the clinical questions asked; the helpfulness of the consultation to requesting physicians; and the differences between consultations performed at a community teaching hospital and those performed at a university hospital. SETTINGS: A community teaching hospital and a university teaching hospital. SUBJECTS: Physicians who formally requested ethics consultations in both hospitals and the patients for whom they requested them. METHODS: Over 2 years (January 1, 1988, to December 31, 1989), we prospectively evaluated a newly established clinical ethics consultation service in a community teaching hospital using confidentially completed, pretested, structured questionnaires, and compared our data with previously reported university hospital data. RESULTS: During the 2-year study, 104 consultation requests were received from 68 physicians in eight departments. Requesters most often requested consultation about deciding to forego life-sustaining treatment (74%), resolving disagreements (46%), and assessing patient competence (30%). Requesters found the consultation "very helpful" or "helpful" in one or more aspects of patient care in 86% of cases, or in one or more aspects of physician education in 86% of cases. These data are similar to university hospital data.

Empowerment of the older patient? A randomized, controlled trial to increase discussion and use of advance directives.

OBJECTIVE: To see if an educational intervention directed at older outpatients would lead to increased use or discussion of advance directives and to characterize patients' reasons for not obtaining advance directives. DESIGN: Randomized, controlled trial of an educational intervention versus usual care. SETTING: Outpatient geriatrics clinic of a university hospital. PATIENTS: One hundred and thirty-one non-demented patients over the age of 65 who did not have an advance directive documented in their record at the start of the study. Forty-eight patients were in the trial arm and 83 in the control. MAIN OUTCOME MEASURES: All patients had their charts reexamined 6 months after enrollment to look for the presence of a living will, a durable power of attorney for health care, or a physician's note describing a discussion of advance directives. Trial patients were also re-interviewed to examine their reasons for not executing an advance directive. MAIN RESULTS: Six months after the intervention, only seven of the 48 trial subjects (15%) had an advance directive or note describing discussion of advance directives in their charts compared to eight of the 83 controls (10%) (P greater than 0.05). When asked to give reasons for not obtaining an advance directive, many patients' responses pointed to procrastination as a significant barrier. CONCLUSIONS: Promoting advance directive use is a complicated task. Barriers other than information and access to documents appear to be involved and need to be addressed in future efforts.

A perinatal ethics committee on abortion: process and outcome in thirty-one cases.

PIP: The US Supreme Court's June 1992 decision to uphold most of Pennsylvania's law restricting access to abortion confirms that while abortion is still permitted in the US, it is being increasingly regulated. Individual institutions may, however, find ways to permit access to abortion. One hospital formed a mandatory, prospective perinatal ethics committee (PEC) in May 1987 to develop clinical guidelines with which to consider and decide requests by physicians for their patients seeking abortions. The authors obtained the consent of this PEC to study its membership, processes, case outcomes, and clinical decision making. Understanding PEC processes and outcomes may help other institutions to decide whether to institute similar mechanisms. Specifically, the investigators determined the backgrounds and abortion-related beliefs of PEC members and obstetric and gynecology department members, whether the PEC affects the number of abortions performed, how PEC members decide in individual cases, and whether requesting physicians find the PEC helpful. All eleven PEC members and 58 of the 65 medical staff ob/gyn physicians returned background surveys. Study results are presented. Overall, the PEC appeared to function as an affirming regulatory body for second-trimester, medically-indicated terminations and for certain personal choice terminations. Institutional interests were well-served by the PEC and with the assurance of informed consent, the interests of some patients were also well served.^ieng

Safety practices and living conditions of low-income urban families.

Injuries remain the leading cause of mortality in children and disproportionately affect poor children. Prior injury prevention efforts have neglected the injury prevention needs of these children. One hundred thirty-three care givers of medically indigent urban children younger than 6 years old were interviewed regarding living conditions, previous injuries, and safety practices and knowledge. Functional smoke detectors and fire extinguishers were present in 75% and 27% of homes, respectively. Few respondents, regardless of previous poisoning experience, were cognizant of ipecac, had it in their homes, or had a good response to a possible poisoning. Few homes had locked storage space, and most hazards were stored suboptimally. While the frequency of the use of automobiles was low, rides in a variety of vehicles were common with 63% of children who usually were restrained inadequately. Additionally, 89% of children aged 35 to 59 months and 6% of those younger than 3 years old sometimes bathed without adult supervision. These findings indicate the dramatic need for injury prevention programs focused on low-income urban families. Specific concerns include exposure to fires and burns, falls, hazardous travel conditions, dangerous chemical, choking, and drowning. Lack of information and isolated care givers may result in poor supervision and responses to injury of these children.

When physicians treat members of their own families. Practices in a community hospital.

BACKGROUND: Little is known about the circumstances under which physicians care for family members. We sought to examine current practice and, in particular, to learn how often family members request medical care or treatment, whether physicians accede to such requests, and what concerns, if any, physicians have about caring for their family members. METHODS: In late 1990 we distributed a pretested, structured questionnaire to all members of the active medical staff (physicians with M.D. or D.O. degrees) of a large suburban community teaching hospital. Of 691 eligible members of the medical staff, 465 physicians responded. RESULTS: Of the 465 respondents, 461 (99 percent) reported requests from family members for medical advice, diagnosis, or treatment. A total of 386 (83 percent of the respondents) had prescribed medication for a family member, 372 (80 percent) had diagnosed medical illnesses, 334 (72 percent) had performed physical examinations, 68 (15 percent) had acted as a family member's primary attending physician in the hospital, and 44 (9 percent) had operated on a family member. In addition, 152 (33 percent) reported that they had observed another physician "inappropriately involved" in a family member's care, and 103 (22 percent) had acceded to a specific request about which they felt uncomfortable. CONCLUSIONS: Practicing physicians often attend and treat their family members and diagnose their illnesses. They may often experience some disquiet in doing so. For physicians, complete medical data, proper training, and sound judgment are essential when family members request treatment.