Ethical considerations in the collection of genetic data from critically ill patients: what do published studies reveal about potential directions for empirical ethics research?

Critical illness trials involving genetic data collection are increasingly commonplace and pose challenges not encountered in less acute settings, related in part to the precipitous, severe and incapacitating nature of the diseases involved. We performed a systematic literature review to understand the nature of such studies conducted to date, and to consider, from an ethical perspective, potential barriers to future investigations. We identified 79 trials enrolling 24 499 subjects. Median (interquartile range) number of participants per study was 263 (116.75-430.75). Of these individuals, 16 269 (66.4%) were Caucasian, 1327 (5.4%) were African American, 1707 (7.0%) were Asian Pacific Islanders and 139 (0.6%) were Latino. For 5020 participants (20.5%), ethnicity was not reported. Forty-eight studies (60.8%) recruited subjects from single centers and all studies examined a relatively small number of genetic markers. Technological advances have rendered it feasible to conduct clinical studies using high-density genome-wide scanning. It will be necessary for future critical illness trials using these approaches to be of greater scope and complexity than those so far reported. Empirical research into issues related to greater ethnic inclusivity, accuracy of substituted judgment and specimen stewardship may be essential for enabling the conduct of such trials.

Developing and implementing new safe practices: voluntary adoption through statewide collaboratives.

BACKGROUND: Disseminating new safe practices has proved challenging. In a statewide initiative we developed a framework for (1) selecting two safe practices, (2) developing operational details of implementation, (3) enlisting hospitals to participate, and (4) facilitating implementation. METHODS: Potential topics were selected by a multistep process to identify candidate practices, review the evidence for efficacy and feasibility, and then select them on the basis of importance, efficacy, feasibility, and impact. A multi-stakeholder advisory group representing all constituencies selected two practices: reconciling medications (RM) and communicating critical test results (CTR). Operational details and strategies for implementation were then developed for each practice using a consensus process of discipline stakeholders led by content experts. Hospital CEOs were solicited to participate by the Massachusetts Hospital Association which made the project a "flagship" initiative. A collaborative model was used to facilitate implementation, following the IHI Model for Improvement. In addition to providing exposure to content and method experts, we gave teams a "toolkit" containing recommendations, a change package, and implementation strategies. Each collaborative met four times over an 18 month period. Results were assessed using the IHI team assessment scale and surveys of teams and hospital leaders. RESULTS: Hospital participation rate was high with 88% of hospitals participating in one or both collaboratives. Partial implementation of the practices was achieved by 50% of RM teams and 65% of CTR teams. Full implementation was achieved by 20% of teams for each. CONCLUSIONS: Major factors leading to hospital participation included the intrinsic appeal of the practices, access to experts, and the availability of implementation strategies. Team success was correlated with active engagement of a senior administrator, engagement of physicians, increased use of PDSA cycles, and attendance at collaborative meetings. The prior development of subpractices, recommendations and implementation strategies was essential for the hospital teams. These should be well worked out before hospitals are required to implement any guideline.

Validation of Toolkit After-Death Bereaved Family Member Interview.

The purpose of this study was to examine the reliability and validity of the Toolkit After-Death Bereaved Family Member Interview to measure quality of care at the end of life from the unique perspective of family members. The survey included proposed problem scores (a count of the opportunity to improve the quality of care) and scales. Data were collected through a retrospective telephone survey with a family member who was interviewed between 3 and 6 months after the death of the patient. The setting was an outpatient hospice service, a consortium of nursing homes, and a hospital in New England. One hundred fifty-six family members from across these settings participated. The 8 proposed domains of care, as represented by problem scores or scales, were based on a conceptual model of patient-focused, family-centered medical care. The survey design emphasized face validity in order to provide actionable information to health care providers. A correlational and factor analysis was undertaken of the 8 proposed problem scores or scales. Cronbach's alpha scores varied from 0.58 to 0.87, with two problem scores (each of which had only 3 survey items) having a low alpha of 0.58. The mean item-to-total correlations for the other problem scores varied from 0.36 to 0.69, and the mean item-to-item correlations were between 0.32 and 0.70. The proposed problem scores or scales, with the exception of closure and advance care planning, demonstrated a moderate correlation (i.e., from 0.44 to 0.52) with the overall rating of satisfaction (as measured by a five-point, "excellent" to "poor" scale). Family members of persons who died with hospice service reported fewer problems in each of the six domains of medical care, gave a higher rating of the quality of care, and reported higher self-efficacy in caring for their loved ones. These results indicate that 7 of the 8 proposed problem scores or scales demonstrated psychometric properties that warrant further testing. The domain of closure demonstrated a poor correlation with overall satisfaction and requires further work. This survey could provide information to help guide quality improvement efforts to enhance the care of the dying.

Toward a national consumer survey: evaluation of the CABHS and MHSIP instruments.

This article describes a study evaluating the Consumer Assessment of Behavioral Health Survey (CABHS) and the Mental Health Statistics Improvement Program (MHSIP) surveys. The purpose of the study was to provide data that could be used to develop recommendations for an improved instrument. Subjects were 3,443 adults in six behavioral health plans. The surveys did not differ significantly in response rate or consumer burden. Both surveys reliably assessed access to treatment and aspects of appropriateness and quality. The CABHS survey reliably assessed features of the insurance plan; the MHSIP survey reliably assessed treatment outcome. Analyses of comparable items suggested which survey items had greater validity. Results are discussed in terms of consistency with earlier research using these and other consumer surveys. Implications and recommendations for survey development, quality improvement, and national policy initiatives to evaluate health plan performance are presented.

Use of consumer ratings for quality improvement in behavioral health insurance plans.

BACKGROUND: The Consumer Assessment of Behavioral Healthcare Services (CABHS) survey collects consumers' reports about their health care plans and treatment. The use of the CABHS to identify opportunities for improvement, with specific attention to how organizations have used the survey information for quality improvement, is described. METHODS: In 1998 and 1999, data were collected from five groups of adult patients in commercial health plans and five groups of adult patients in public assistance health plans with services received through four organizations (one of three managed behavioral health care organizations or a health system). Patients who received behavioral health care services during the previous year were mailed the CABHS survey. Non-respondents were contacted by telephone to complete the survey. RESULTS: Response rates ranged from 49% to 65% for commercial patient groups and from 36% to 51% for public assistance patients. Promptly getting treatment from clinicians and aspects of care most influenced by health plan policies and operations, such as access to treatment and plan administrative services, received the least positive responses, whereas questions about communication received the most positive responses. In addition, questions about access- and plan-related aspects of quality showed the most interplan variability. Three of the organizations in this study focused quality improvement efforts on access to treatment. DISCUSSION: Surveys such as the CABHS can identify aspects of the plan and treatment that are improvement priorities. Use of these data is likely to extend beyond the behavioral health plan to consumers, purchasers, regulators, and policymakers, particularly because the National Committee for Quality Assurance is encouraging behavioral health plans to use a similar survey for accreditation purposes.

What triggers requests for ethics consultations?

OBJECTIVES: While clinical practice is complicated by many ethical dilemmas, clinicians do not often request ethics consultations. We therefore investigated what triggers clinicians' requests for ethics consultation. DESIGN: Cross-sectional telephone survey. SETTING: Internal medicine practices throughout the United States. PARTICIPANTS: Randomly selected physicians practising in internal medicine, oncology and critical care. MAIN MEASUREMENTS: Socio-demographic characteristics, training in medicine and ethics, and practice characteristics; types of ethical problems that prompt requests for consultation, and factors triggering consultation requests. RESULTS: One hundred and ninety of 344 responding physicians (55%) reported requesting ethics consultations. Physicians most commonly reported requesting ethics consultations for ethical dilemmas related to end-of-life decision making, patient autonomy issues, and conflict. The most common triggers that led to consultation requests were: 1) wanting help resolving a conflict; 2) wanting assistance interacting with a difficult family, patient, or surrogate; 3) wanting help making a decision or planning care, and 4) emotional triggers. Physicians who were ethnically in the minority, practised in communities under 500,000 population, or who were trained in the US were more likely to request consultations prompted by conflict. CONCLUSIONS: Conflicts and other emotionally charged concerns triggers consultation requests more commonly than other cognitively based concerns. Ethicists need to be prepared to mediate conflicts and handle sometimes difficult emotional situations when consulting. The data suggest that ethics consultants might serve clinicians well by consulting on a more proactive basis to avoid conflicts and by educating clinicians to develop mediation skills.

Attitudes and practices among pediatric oncologists regarding end-of-life care: results of the 1998 American Society of Clinical Oncology survey.

PURPOSE: In 1998, the American Society of Clinical Oncology (ASCO) surveyed its membership to assess the attitudes, practices, and challenges associated with end-of-life care of patients with cancer. In this report, we summarize the responses of pediatric oncologists and the implications for care of children dying from cancer. METHODS: The survey consisted of 118 questions, covering eight categories. All ASCO members in the United States, Canada, and the United Kingdom were mailed a survey, which was completed by 228 pediatric oncologists. Predictors of particular attitudes and practices were identified using stepwise logistic regression analysis. Potential predictors were age, sex, religious affiliation, importance of religious beliefs, recent death of a relative, specialty, type of practice (rural or urban, academic or nonacademic), amount of time spent in patient care, number of new patients in the past 6 months, and number of patients who died in the past year. RESULTS: Pediatric oncologists reported a lack of formal courses in pediatric palliative care, a strikingly high reliance on trial and error in learning to care for dying children, and a need for strong role models in this area. The lack of an accessible palliative care team or pain service was often identified as a barrier to good care. Communication difficulties exist between parents and oncologists, especially regarding the shift to end-of-life care and adequate pain control. CONCLUSION: Pediatric oncologists are working to integrate symptom control, psychosocial support, and palliative care into the routine care of the seriously ill child, although barriers exist that make such comprehensive care a challenge.

Attitudes and practices of U.S. oncologists regarding euthanasia and physician-assisted suicide.

BACKGROUND: The practices of euthanasia and physician-assisted suicide remain controversial. OBJECTIVE: To achieve better understanding of attitudes and practices regarding euthanasia and physician-assisted suicide in the context of end-of-life care. DESIGN: Cohort study. SETTING: United States. PARTICIPANTS: 3299 oncologists who are members of the American Society of Clinical Oncology. MEASUREMENTS: Responses to survey questions on attitudes toward euthanasia and physician-assisted suicide for a terminally ill patient with prostate cancer who has unremitting pain, requests for and performance of euthanasia and physician-assisted suicide, and sociodemographic characteristics. RESULTS: Of U.S. oncologists surveyed, 22.5% supported the use of physician-assisted suicide for a terminally ill patient with unremitting pain and 6.5% supported euthanasia. Oncologists who were reluctant to increase the dose of intravenous morphine for terminally ill patients in excruciating pain (odds ratio [OR], 0.61 [95% CI, 0.48 to 0.77]) and had sufficient time to talk to dying patients about end-of-life care issues (OR, 0.79 [CI, 0.71 to 0.87]) were less likely to support euthanasia or physician-assisted suicide. During their career, 3.7% of surveyed oncologists had performed euthanasia and 10.8% had performed physician-assisted suicide. Oncologists who were reluctant to increase the morphine dose for patients in excruciating pain (OR, 0.58 [CI, 0.43 to 0.79]) and those who believed that they had received adequate training in end-of-life care (OR, 0.86 [CI, 0.79 to 0.95]) were less likely to have performed euthanasia or physician-assisted suicide. Oncologists who reported not being able to obtain all the care that a dying patient needed were more likely to have performed euthanasia (P = 0.001). CONCLUSIONS: Requests for euthanasia and physician-assisted suicide are likely to decrease as training in end-of-life care improves and the ability of physicians to provide this care to their patients is enhanced.

Patient-centered quality measures for Asian Americans: research in progress.

We aim to develop and validate a questionnaire that examines quality of care from the patient's perspective for limited-English-proficient Asian Americans (AA) of Chinese and Vietnamese descent. We will conduct focus groups of patients to identify issues important to them, with an emphasis on communication and access to care. We will then draft a questionnaire and test its validity using standard survey research methods and direct observation of patient-provider encounters. Subsequent field testing will involve face-to-face patient interviews 1 month after an outpatient visit. We will evaluate alternate modes of administration to test feasibility and to maximize response. The result of our study will be a validated, culturally sensitive, patient-centered instrument that measures health care quality for limited-English-proficient AA patients. Our research will provide a template for developing future quality measures for other vulnerable populations.

Stability of attitudes regarding physician-assisted suicide and euthanasia among oncology patients, physicians, and the general public.

PURPOSE: Attitudes regarding the ethics of physician-assisted suicide (PAS) and euthanasia have been examined in many cross-sectional studies. Stability of these attitudes has not been studied, and this is important in informing the dialog on PAS in this country. We evaluated the stability of attitudes regarding euthanasia and PAS among three cohorts. METHODS: Subjects included 593 respondents: 111 oncology patients, 324 oncologists, and 158 members of the general public. We conducted initial and follow-up interviews separated by 6 to 12 months by telephone, regarding acceptance of PAS and euthanasia in four different clinical vignettes. RESULTS: The proportion of respondents with stable responses to vignettes ranged from 69.2% to 94.8%. In comparison to patients and the general public, physicians had less stable responses concerning the PAS pain vignette (69.1% v 80.8%; P =.001) and more stable responses for all euthanasia vignettes (P <.001) except for pain. Over time, physicians were significantly more likely to change toward opposing PAS and euthanasia in all vignettes (P <.05). Characteristics previously associated with attitudes regarding PAS and euthanasia, such as Roman Catholic religion, were not predictive of stability. CONCLUSION: Up to one third of participants changed their attitudes regarding the ethical acceptability of PAS and euthanasia in their follow-up interview. This lack of consistency mandates careful interpretation of referendums and requests for physician-assisted suicide. Furthermore, in this study, we found that physicians are becoming increasingly opposed to PAS and euthanasia. The growing disparity between physicians and patients regarding the role of these practices is large enough to suggest possible conflicts in the delivery of end-of-life care.

Development of a consumer survey for behavioral health services.

A consumer survey was designed to assess the quality of mental health and substance abuse services and evaluate insurance plans that provide such services. This paper describes the development of the Consumer Assessment of Behavioral Health Services instrument, which began with a review of existing consumer satisfaction surveys and input from several groups working toward development of nationally standardized satisfaction instruments. Consumer focus groups were used to ensure that all the important domains of quality were included, and group members were interviewed to ensure that all items on the instrument were understandable. Results of a pilot test conducted with 160 consumers, 82 enrolled in Medicaid plans and 78 in commercial plans, suggested that the survey was able to distinguish between the two groups in terms of evaluations of their care and insurance plans. Future efforts will focus on further testing of larger, more diverse samples and on developing scoring and reporting formats for the survey that will be useful to consumers and purchasers in choosing behavioral health services and plans.

The practice of euthanasia and physician-assisted suicide in the United States: adherence to proposed safeguards and effects on physicians.

CONTEXT: Despite intense debates about legalization, there are few data examining the details of actual euthanasia and physician-assisted suicide (PAS) cases in the United States. OBJECTIVE: To determine whether the practices of euthanasia and PAS are consistent with proposed safeguards and the effect on physicians of having performed euthanasia or PAS. DESIGN: Structured in-depth telephone interviews. SETTING AND PARTICIPANTS: Randomly selected oncologists in the United States. OUTCOME MEASURES: Adherence to primary and secondary safeguards for the practice of euthanasia and PAS; regret, comfort, and fear of prosecution from performing euthanasia or PAS. RESULTS: A total of 355 oncologists (72.6% response rate) were interviewed on euthanasia and PAS. On 2 screening questions, 56 oncologists (15.8%) reported participating in euthanasia or PAS; 53 oncologists (94.6% response rate) participated in in-depth interviews. Thirty-eight of 53 oncologists described clearly defined cases of euthanasia or PAS. Twenty-three patients (60.5%) both initiated and repeated their request for euthanasia or PAS, but 6 patients (15.8%) did not participate in the decision for euthanasia or PAS. Thirty-seven patients (97.4%) were experiencing unremitting pain or such poor physical functioning they could not perform self-care. Physicians sought consultation in 15 cases (39.5%). Overall, oncologists adhered to all 3 main safeguards in 13 cases (34.2%): (1) having the patient initiate and repeat the request for euthanasia or PAS, (2) ensuring the patient was experiencing extreme physical pain or suffering, and (3) consulting with a colleague. Those who adhered to the safeguards had known their patients longer and tended to be more religious. In 28 cases (73.7%), the family supported the decision. In all cases of pain, patients were receiving narcotic analgesia. Fifteen patients (39.5%) were enrolled in a hospice. While 19 oncologists (52.6%) received comfort from having helped a patient with euthanasia or PAS, 9 (23.7%) regretted having performed euthanasia or PAS, and 15 (39.5%) feared prosecution. CONCLUSIONS: Intractable pain or poor physical functioning seem to be nearly absolute requirements for physicians to perform euthanasia or PAS. Only one third of cases are performed consistently with proposed safeguards. For some patients, end-of-life care that includes opioid analgesia and hospice care does not obviate their desire for euthanasia or PAS. While the majority of physicians seem comforted by their actions, some experience adverse consequences from having performed euthanasia or PAS.

Euthanasia and physician-assisted suicide: attitudes and experiences of oncology patients, oncologists, and the public.

BACKGROUND: Euthanasia and physician-assisted suicide are pressing public issues. We aimed to collect empirical data on these controversial interventions, particularly on the attitudes and experiences of oncology patients. METHODS: We interviewed, by telephone with vignette-style questions, 155 oncology patients, 355 oncologists, and 193 members of the public to assess their attitudes and experiences in relation to euthanasia and physician-assisted suicide. FINDINGS: About two thirds of oncology patients and the public found euthanasia and physician-assisted suicide acceptable for patients with unremitting pain. Oncology patients and the public found euthanasia and physician-assisted suicide least acceptable in vignettes involving "burden on the family" and "life viewed as meaningless". In no vignette--even for patients with unremitting pain--did a majority of oncologists find euthanasia or physician-assisted suicide ethically acceptable. Patients actually experiencing pain were more likely to find euthanasia or physician-assisted suicide unacceptable. More than a quarter of oncology patients had seriously thought about euthanasia or physician-assisted suicide and nearly 12 percent had seriously discussed these interventions with physicians or others. Patients with depression and psychological distress were significantly more likely to have seriously discussed euthanasia, hoarded drugs, or read Final Exit. More than half of oncologists had received requests for euthanasia or physician-assisted suicide. Nearly one in seven oncologists had carried out euthanasia or physician-assisted suicide. INTERPRETATION: Euthanasia and physician-assisted suicide are important issues in the care of terminally ill patients and while oncology patients experiencing pain are unlikely to desire these interventions patients with depression are more likely to request assistance in committing suicide. Patients who request such an intervention should be evaluated and, where appropriate, treated for depression before euthanasia can be discussed seriously.

Reaching children of the uninsured and underinsured in two rural Wisconsin counties: findings from a pilot project.

Debates about the accessibility, costs, and coverages of health care for the population at large have recently accelerated. This paper addresses some of the demographic, health, and fiscal ramifications of creating a preventive health care bridge to children in uninsured and underinsured families in two rural Wisconsin counties. The study findings revealed that the initial health status of children making a preventive health visit under a minimal copayment plan was noticeably worse than the status of those who had the free Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program available to them on a more or less continual basis. Upon their first visit, the children who did not have access to a free EPSDT program had a greater number of medical and dental health problems and fewer preventive dental care visits than their EPSDT contemporaries. Beyond a greater number of problems, however, we found no noticeable differences between the two groups in the types of health problems present (i.e. the clinical distribution of the problems was similar across the two groups). This paper also contrasts referral completion rates and rates of diagnostic confirmation of identified problems between the two groups. Finally, we provide estimates of the cost of coverage for each unprotected child.

Verbal consultation regarding prescription drugs: findings from a statewide study.

In 1984 the Wisconsin Division of Health showed interest in patients' receipt of verbal consultation for prescription drugs and included relevant questions in the Wisconsin Health Status survey to: 1) investigate the receipt of verbal consultation for new and refill prescriptions, 2) allow a comparison of state results with those of a national study that used similar sampling and data collection procedures, and 3) more closely examine the relationships between receipt of verbal consultation and such variables as prescription status (new or refill), age, sex, race, and education. Data were collected from 2,135 randomly selected respondents using Computer Assisted Telephone Interviewing with random digit dialing. After controlling for elapsed time since last prescription, log-linear analyses showed the importance of prescription status (new and refill) and respondent's age as correlates of consultation by pharmacy personnel, while prescription status, age, and sex were significant for prescribers. For both prescribers and pharmacy personnel, the authors found no association between client education and receipt of verbal consultation. The absence of verbal consultation cannot be entirely accounted for by client characteristics or prescription status. Based upon their experience, the authors encourage continued monitoring of prescribers' and pharmacists' provision of verbal consultation through questions contained in state and national health status surveys.

Block grant nutrition services in Wisconsin: an empirical view.

This research applies standard nomenclature and data collection techniques to block grant-funded nutrition services in Wisconsin in 1985 and 1986. We discuss the way public sector nutritionists spent their time and the health conditions of the clients they saw. Analysis reveals both positive and negative factors associated with block grant support of nutrition services. Block grants have afforded some local agencies the needed flexibility to hire nutritionists. Moreover, distributions of clients by demographic characteristics and diagnoses clearly reveal that the nutrition services reached their intended targets, among them several groups that were not likely to have been reached any other way. Especially noteworthy were the limited services provided to the homebound. On the other hand, because the funding was narrowly applied in the case of Maternal and Child Health Block Grants and was of very limited size in the case of Prevention Block Grants, needy groups continue to be missed. These include adolescent and adult males and the developmentally disabled. A final section of our analysis examines the average time spent by nutritionists per client visit. These results are presented in the context of service delivery and diagnostic categories. We conclude that use of block grant funding can add flexibility in meeting the need for nutrition services, but that it is restricted in scope.

The use of female spouse proxies in common symptom reporting.

To determine the quality of proxy health reports by telephone the 1984 Wisconsin Health Status Survey employed a repeated-measure design in an interview covering 22 recently occurring health and psychologic complaints. Comparisons on individuals in households containing two or more adults revealed a relatively weak correspondence between the respondent and proxy reports. While a previous analysis of these data found that certain characteristics thought to underlie reporting differences are not useful in explaining proxy underreporting, the current analysis focuses on spousal pairs and achieves greater success by applying somewhat more sophisticated methods. The authors examined the nature, persistence, and number of health complaints as factors in reporting bias. They find evidence that female proxies vary by symptom in their ability to report common complaints and also observed that proxy underreporting diminishes somewhat as the persistence of symptoms increases. Using multiplicative models, the authors show that the gross misclassification of complaints is concentrated in the respondent-proxy pairs with the shortest exposure to the symptom. Finally, an examination of the disagreements on all 22 health complaints simultaneously revealed that neither mutual misallocation by respondents and proxies nor a diminished health status of the individual reported on are important influences on reporting behavior.