Robert M. Arnold

Identifying, recruiting, and retaining seriously-ill patients and their caregivers in longitudinal research

Background: In order to improve the state of science in palliative care, we must increase our ability to document the real-time experience of patients and families as they traverse the end of life. Yet, frequently, prospective measurement is impeded by difficulty with patient identification, recruitment, enrollment, and retention. The palliative care literature is replete with descriptions of studies unable to meet enrollment goals, and that as a result, do not have adequate power to test hypotheses or draw conclusions. Objectives: To review the literature describing difficulties associated with ascertainment, enrollment, and attrition. To outline the successful recruitment methods of a new longitudinal study of patients and their caregivers. Design: A two-year longitudinal study of 240 patients with Stage IV cancer (breast, prostate, colorectal, lung), advanced congestive heart failure (CHF) LVEFB < 40 or advanced chronic obstructive pulmonary disease (COPD) pCO2 > 46, and their caregivers, interviewed monthly for up to two years. Patients were identified using clinical and administrative databases from one geographic region. Results: Representative and successful ascertainment was associated with use of clinical criteria and medical record review versus physician or other provider prognostication, use of recruitment letters from personal physician, recruitment letter content, brochure content, small monetary incentives, refined phone scripts, use of matched ethnicity interviewers, in-home and phone interview strategies, measure selection, patient and caregiver rapport, and on-going staff support (including grief and bereavement). Conclusions: Recruitment to prospective longitudinal studies at the end of life is difficult, but possible. The lessons learned from this study are applicable to future investigators conducting prospective research.

Medical Ethics Education: Past, Present, and Future.

Abstract This paper examines undergraduate medical ethics education in the United States during its 25‐year history. Included is a brief description of early efforts in medical ethics education and a discussion of the traditional model of ethics teaching, which emphasizes the knowledge and cognitive skills necessary for ethical decision making. The authors also discuss alternatives to the traditional model that focus more directly on students personal values, attitudes, and behavior. Current areas of consensus in the field are then explored. Finally, the authors identify three incipient trends in medical ethics education — toward increased emphasis on everyday ethics, student ethics, and macroethics. Throughout the paper, examples of specific courses and curricula are used to illustrate the modes and trends described. Acad. Med. 70(1995): 761–769.

Patient Knowledge and Physician Predictions of Treatment Preferences After Discussion of Advance Directives

OBJECTIVE: To determine patient knowledge about life-sustaining treatments and physician understanding of patient preferences for proxies and treatments after outpatient discussions about advance directives.DESIGN: Cross-sectional interview-based and questionnaire-based survey.SETTING: Two university general internal medicine practices, two Department of Veterans Affairs general internal medicine practices, and one university-based geriatrics practice, in two different cities.PATIENTS: Fifty-six patients of primary care internists.INTERVENTION: Physicians discussed “advance directives” (ADs) with one randomly selected patient during an outpatient visit.MEASUREMENTS AND MAIN RESULTS: After the discussions, physicians identified the patient’s proxy and predicted the patient’s preferences for treatment in 20 scenarios. Patients provided treatment preferences in the 20 scenarios, the name of their preferred surrogate decision maker, and their understanding of cardiopulmonary resuscitation and mechanical ventilation. Of the 39 patients who discussed resuscitation, 43% were able to identify two important characteristics; 26% identified none; 66% did not know that most patients need mechanical ventilation after undergoing resuscitation. None of the 43 patients who had a discussion about mechanical ventilation had a good understanding of it; 67% did not know that patients generally cannot talk while on ventilators; 46% expressed serious misconceptions about ventilators. There was poor agreement between physicians and their patients regarding treatment preferences in 18 of 20 scenarios (κ −0.04 to 0.31). Physicians correctly identified the proxy 89% of the time (κ 0.78).CONCLUSIONS: Patients leave routine AD discussions with serious misconceptions about life-sustaining treatments. Physicians are unable to predict treatment preferences but do learn about patients’ preferences for surrogate decision makers.

Association Between Palliative Care and Patient and Caregiver Outcomes: A Systematic Review and Meta-analysis

Importance The use of palliative care programs and the number of trials assessing their effectiveness have increased. Objective To determine the association of palliative care with quality of life (QOL), symptom burden, survival, and other outcomes for people with life-limiting illness and for their caregivers. Data Sources MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL to July 2016. Study Selection Randomized clinical trials of palliative care interventions in adults with life-limiting illness. Data Extraction and Synthesis Two reviewers independently extracted data. Narrative synthesis was conducted for all trials. Quality of life, symptom burden, and survival were analyzed using random-effects meta-analysis, with estimates of QOL translated to units of the Functional Assessment of Chronic Illness Therapy-palliative care scale (FACIT-Pal) instrument (range, 0-184 [worst-best]; minimal clinically important difference [MCID], 9 points); and symptom burden translated to the Edmonton Symptom Assessment Scale (ESAS) (range, 0-90 [best-worst]; MCID, 5.7 points). Main Outcomes and Measures Quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Results Forty-three RCTs provided data on 12 731 patients (mean age, 67 years) and 2479 caregivers. Thirty-five trials used usual care as the control, and 14 took place in the ambulatory setting. In the meta-analysis, palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08 to 0.83; FACIT-Pal mean difference, 11.36] and symptom burden at the 1- to 3-month follow-up (standardized mean difference, -0.66; 95% CI, -1.25 to -0.07; ESAS mean difference, -10.30). When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06 to 0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was not statistically significant (standardized mean difference, -0.21; 95% CI, -0.42 to 0.00; ESAS mean difference, -3.28). There was no association between palliative care and survival (hazard ratio, 0.90; 95% CI, 0.69 to 1.17). Palliative care was associated consistently with improvements in advance care planning, patient and caregiver satisfaction, and lower health care utilization. Evidence of associations with other outcomes was mixed. Conclusions and Relevance In this meta-analysis, palliative care interventions were associated with improvements in patient QOL and symptom burden. Findings for caregiver outcomes were inconsistent. However, many associations were no longer significant when limited to trials at low risk of bias, and there was no significant association between palliative care and survival.

Communication about cancer near the end of life.

Cancer communication near the end of life has a growing evidence base, and requires clinicians to draw on a distinct set of communication skills. Patients with advanced and incurable cancers are dealing with the emotional impact of a life‐limiting illness, treatment decisions that are complex and frequently involve consideration of clinical trials, and the challenges of sustaining hope while also having realistic goals. In this review, the authors sought to provide a guide to important evidence about communication for patients with advanced cancer regarding communication at diagnosis, discussing prognosis, decision making about palliative anticancer therapy and phase 1 trials, advance care planning, transitions in focus from anticancer to palliative care, and preparing patients and families for dying and death. Cancer 2008;113(7 suppl):1897–910.

Discussing Prognosis: “How Much Do You Want to Know?” Talking to Patients Who Are Prepared for Explicit Information

Mrs D, a 57-year-old woman with metastatic pancreatic cancer, is discussing treatment options with Dr B. How much should I tell her about prognosis? he wonders. She already seems nervous. Do I hand her the death sentence? Or sugarcoat the statistics? Maybe I’ll wait to see if she asks. For the first time Mrs D looks up and says, “What should I expect?” Dr B balks, not having decided what to say. “Umm, I can’t really predict,” he mumbles. “Every patient is different.” Perhaps I am mumbling, thinks Dr B, because I’m not telling her the whole truth. Mrs D nods vaguely without meeting his gaze and picks up her purse to leave. Is she dissatisfied also? Dr B finds himself in a familiar dilemma: how much information should an oncologist give about a bad prognosis? One of his colleagues prides himself on being a realist, “I tell patients the truth because they need to know, whether they want to hear it or not.” Another colleague feels he must give hope, “I go into cheerleader mode.” Neither alternative seems optimal to Dr B—the nurses tell him that the realist tone is a little brutal, and that the cheerleader is more than a little clueless. Privately, Dr B feels his own practice—avoiding prognosis by emphasizing individual differences—borders on disingenuous. He knows a lot more about what will happen to Mrs D than he is letting on. Realism, optimism, and avoidance are the most common strategies physicians use in discussing prognosis. Although these strategies are well intended and commonly used, they also create unintended consequences. In this article, a patient-centered method for disclosing prognosis is proposed and illustrated. The method builds on existing empirical evidence about discussing prognosis by drawing on principles of negotiation and patient-centered approaches. This approach enables an oncologist to figure out what kind of prognostic information to disclose with a particular patient at a particular time and how to individualize the discussion. This article describes how the approach works with a patient who is ready for an explicit discussion. STRATEGIES WITH UNINTENDED CONSEQUENCES: REALISM, OPTIMISM, AVOIDANCE

The Dead Donor Rule: Should We Stretch It, Bend It, or Abandon It?

The dead donor rule—that persons must be dead before their organs are taken—is a central part of the moral framework underlying organ procurement. Efforts to increase the pool of transplantable organs have been forced either to redefine death (e.g., anencephaly) or take advantage of ambiguities in the current definition of death (e.g., the Pittsburgh protocol). Societys growing acceptance of circumstances in which health care professionals can hasten a patients death also may weaken the symbolic importance of the dead donor rule. We consider the implications of these efforts to continually revise the line between life and death and ask whether it would be preferable to abandon the dead donor rule and rely entirely on informed consent as a safeguard against abuse.

The process of organ donation and its effect on consent.

Objective: To identify those factors that enhance or inhibit organ donation in order to provide data to help policy makers, hospital administrators and transplantation professionals make informed choices about how to modify the donor system and to structure ‘best practice’ interventions. 
Summary of background data: Legislative efforts to increase donation rates have not been successful. An emphasis on process is needed to help explain this. 
Methods: The study was conducted using a stratified random sample of 23 hospitals in the Pittsburgh and Minneapolis/St Paul standard statistical metropolitan areas. Each week, the medical charts of all in‐patient and emergency room patient deaths at each hospital were reviewed using a standardized review protocol to determine eligibility for organ, tissue, and cornea donation. A total of 10 681 patient charts were reviewed over a 4‐yr period. Eight hundred and twenty‐eight cases out of 1 723 eligible cases were selected for inclusion in the study. Data were collected on 827 of these cases. All health care providers (HCPs) who spoke with the family after the patients death or discussed donation with the family were interviewed. 
Results: Of the 10 681 patient charts reviewed, 16.5% were eligible to donate either organs, tissues, or corneas, and 87.0% of donor‐eligible patients’ families were approached and asked to donate. Consent rates were 23.5% for corneas, 34.5% for tissues, and 46.5% for organ donation. Multiple logistic regression demonstrated that the best and strongest predictor of donation decisions was the familys initial response to the donation request, as reported by the HCP. Three initial response groups are examined and compared. Those families who expressed an initially favorable reaction were most likely to agree to donation. Furthermore, discussion patterns differed by initial reaction group, with families who expressed initial indecision about donation sharing more characteristics with families who were not favorable than those who were favorable. More detailed information was provided to the favorable families, as compared to the other two groups, concerning the effect of donation on funeral arrangements and costs. Families who were favorable were also more likely to meet with an organ procurement organization representative than were other families. The strongest predictor of a familys unfavorable response to a donation request was the belief that the patient would have been against donation. A number of other variables, including HCP attitudes, also had an impact on the familys decision to donate. 
Conclusions: A number of discussion and HCP characteristics are associated with a familys willingness to consent to organ donation. Further study is needed to determine if interventions based on the characteristics identified in this study will increase consent to donation.

Reflective teaching practices: An approach to teaching communication skills in a small-group setting

Small-group teaching is particularly suited for complex skills such as communication. Existing work has identified the basic elements of small-group teaching, but few descriptions of higher-order teaching practices exist in the medical literature. Thus the authors developed an empirically driven and theoretically grounded model for small-group communication-skills teaching. Between 2002 and 2005, teaching observations were collected over 100 hours of direct contact time between four expert facilitators and 120 medical oncology fellows participating in Oncotalk, a semiannual, four-day retreat focused on end-of-life communication skills. The authors conducted small-group teaching observations, semistructured interviews with faculty participants, video or audio recording with transcript review, and evaluation of results by faculty participants. Teaching skills observed during the retreats included a linked set of reflective, process-oriented teaching practices: identifying a learning edge, proposing and testing hypotheses, and calibrating learner self-assessments. Based on observations and debriefings with facilitators, the authors developed a conceptual model of teaching that illustrates an iterative loop of teaching practices aimed at enhancing learners’ engagement and self-efficacy. Through longitudinal, empirical observations, this project identified a set of specific teaching skills for small-group settings with applicability to other clinical teaching settings. This study extends current theory and teaching practice prescriptions by describing specific teaching practices required for effective teaching. These reflective teaching practices, while developed for communication skills training, may be useful for teaching other challenging topics such as ethics and professionalism.

Discussing end-of-life issues with terminally ill cancer patients and their carers: a qualitative study

Goals of workDiscussing end-of-life issues is of key importance to terminally ill cancer patients and their families, and a challenging topic for both health professionals and patients/carers. There is a lack of research evidence in the literature to guide clinical practice. The objective of this study was to explore the optimal content and phrasing of information when discussing the dying process and end-of-life issues with terminally ill cancer patients and their carers.Subjects and methodsWe conducted focus groups and individual interviews with 19 palliative care patients and 24 carers from three palliative care services in Sydney, and 22 palliative care health professionals from around Australia. The focus groups and individual interviews were audiotaped and fully transcribed. Further focus groups and/or individual interviews were conducted until no additional topics were raised. Participants’ narratives were analysed using qualitative methodology.Main resultsDistinct content areas emerged for discussing end-of-life issues: treatment decisions at the end-of-life; potential future symptoms; preferences for place of death; the process of dying; what needs to be done immediately after death; and existential issues. When discussing the process of dying participants recommended: exploring the persons’ fears about dying and dispelling myths; describing the final days and the likely unconscious period; and the reduced need for food and fluids. Many participants identified the dilemma regarding whether to discuss potential complications around the time of death.ConclusionsThis paper provides strategies, words and phrases which may inform discussions about the process of dying and end-of-life issues. Further research is needed to determine the generalizability of these findings.