Outreach/Ethics

Educational Objectives

The goals of this program are to improve end-of-life experiences among patients and families, and to improve the management of conflicts of interest. After hearing and assimilating this program, the clinician will be better able to:

1.   Provide support to families while caring for a dying patient.

2.   Utilize effective communication skills when delivering unwelcome news.

3.   Discuss end-of-life decisions in a manner that is helpful to patients, families, and physicians.

4.   Prioritize and respond to common end-of-life concerns.

5.   Implement institutional policies intended to prevent conflicts of interest and preserve academic integrity.

Faculty Disclosure

In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the plan­ning committee to disclose relevant financial relationships within the past 12 months that might create any personal con­flicts of interest. Any identified conflicts were resolved to ensure that this educational activity promotes quality in health care and not a proprietary business or commercial interest. For this program, the faculty and planning committee reported nothing to disclose.

Acknowledgments

Drs. Hiatt and Cederquist were recorded at 16th Annual USC Trauma/Critical Care Symposium, held March 12-13, 2009, in Pasadena, CA, and sponsored by The Division of Trauma/Critical Care and the Office of Continuing Medical Education, Keck School of Medicine of the University of Southern California, and the Institute of Continuing Education for Nurses, Department of Nursing, Los Angeles County USC Medical Center. Dr. Mansfield was recorded at Critical Care, held July 23-25, 2009, in San Diego, CA, and sponsored by the University of California, San Diego, School of Medicine. The Audio-Digest Foundation thanks the speakers and the sponsors for their cooperation in the production of this program.

Death and Dying: Treating the Family

Jonathan R. Hiatt, MD, Professor and Chief of General Surgery, David Geffen School of Medicine at the Uni­versity of California, Los Angeles

Mortality overview: encountered by all physicians; »2,500,000 deaths in United States annually (2006 statistics); leading causes disease processes encountered in intensive care unit (ICU); accidents and trauma fifth most common cause of death

Considerations for medical professionals: poor communication skills often cause confusion, stress, and resentment; good communication skills shown to assist understanding, acceptance, and adjustment; residency programs often include development of interpersonal skills, communication skills, and professionalism as core goals

Cultural issues: influence how patients prefer to bear and receive unwelcome news; also affects attitude toward open discussion; patients may report worse experiences with physicians whose cultural backgrounds differ from their own; some cultures believe articulating bad news creates adverse consequences; caregivers should address cross-cultural issues with openness and recognize that their own personal values and beliefs may differ from those of their patients and patients’ families; assessing cultural differences  —  “abcde” mnemonic; take into account atti­tudes and beliefs of patients and families, context of interaction, relevant culturally-rooted decision-making styles, and environment

Communication: prepare for encounter (eg, consider message, approach, family’s level of understanding, responses to emotions, offering to discuss implications); treat first meeting as part of ongoing process; document conversation in medical records; discouraged behavior  —  blocking; redirecting conversation; lecturing (communication should invite interaction and feedback); collusion (ie, avoiding specific subjects); premature reassurance; sympathy rather than empathy (speaker defines sympathy as “something you give”, empathy as  “something you share”); encour­aged behavior  —  “ask, tell, ask” (continual interaction); soliciting information from family; responding to emotion; encouraging communication between patients and family (establishes trust); ensuring that communication from consultants or specialists consistent with communication from primary care providers; acknowledging errors; showing humility and respect; not emphasizing decision making (during initial conversations); reframing hope with focus on short-term goals (eg, maintaining comfort for patient); working with interpreters  —  set up triangular con­figuration for meeting (allowing clinician and families to remain central focus); maintain eye contact and commu­nication style with families, even when relying on translator; ensure that translation direct and complete; identify misunderstandings

Intensive care unit: hydrate, feed, and rest families along with patients; families may be involved in care, healing process, and overall management; institutions often lack mechanisms for identifying “futile care” (prolonged and excessive care relative to expected outcomes); French study (Lautrette et al)  —  prospective study; 22 ICUs; 126 dy­ing patients randomized to control group (standard end-of-life conference) or specific intervention; specific inter­vention group reported superior results (lower hospital anxiety, depression scores, and prevalence of post-traumatic stress symptoms)

Trauma: often unexpected and may involve young victims; mass casualty situations may limit resources (eg, time); family perspective study (Jurkovich et al)  —  included 54 family members of 48 deceased trauma patients (69% died within 2 days, 83% within 1 wk); attitude of physician or person delivering information, clarity of message, pri­vacy, and receiving answers to questions critical; attire or rank and seniority of newsgiver had little effect; study (Archives of Surgery)  —telephone survey of 1000 members of public and 774 trauma professionals; »46% of both groups underwent emergency care in past 10 yr; 12% lost loved one or family member; members of public typically felt patients should receive transport even when declared dead at scene (contrasting with professionals); both groups preferred staying in treatment room (even with excessive blood or when victim was child); trauma profes­sionals typically favored “comfort care” rather than aggressive care; majority of both groups felt life-sustaining treatment should stop once doctors rule out hope of recovery; both groups felt efforts should continue regardless of financial costs (opinion stronger among public); 72% of public felt loved ones had right to demand care, even after determined futile by physicians (vs 44% of professionals)

Communication in End-of-Life Decisions

Lynette Cederquist, MD, Clinical Professor of Medicine, University of California, San Diego, School og Medi­cine

Prognostication: vital component in determining achievable goals of care; physicians’ assessments often become less objective and overly optimistic with longstanding relationships or extended treatment; when outcome remains uncertain, physicians may avoid prognostication (unhelpful to families making difficult decisions) and focus on day-to-day details of care; giving blunt, hopeless prognosis causes pointless despair in families; truth must be bal­anced with maintaining hope for patients; predicting mortality  —specific time predictions inaccurate and unhelp­ful; speaker recommends explaining inaccuracy of specific predictions when asked; general timeframes (eg, hours or days, days or weeks, weeks or months) typically sufficient for preparations by families; less specific prognosti­cations leave greater room for hope; uncertainty  —  often causes physicians to avoid discussing outcomes; remind patients to hope for best possible outcome but prepare for unexpected

Discussion: discuss poor outcomes in hypothetical terms; speaker recommends initiating end-of-life discussions ear­lier in course of hospitalization; patients may show declines in cognitive status during course of hospitalization (complicates decision-making); in studies, patients consistently reported reduced anxiety after discussing end-of-life decisions and advanced care planning; patients often fear not having control over mortality, but often unsure of how to initiate discussion; communicating care decisions relieves anxiety and assures respect for patient’s values and wishes; establishing patient’s wishes reduces family conflicts related to care decisions

Decisions: begin decision-making process by discussing goals (prognostication skills important; all parties should reach consensus); patients and families may mistakenly believe treatment goals include curative outcome or com­plete recovery; realistic levels of expectation must be understood by all individuals involved; with incurable illness, goals typically include extending life or improving quality of life; if extending or improving life not achievable, goals should focus on alleviation of suffering; physicians should strive to facilitate peaceful and dignified deaths; fi­nal location  — ask patients and families where death should preferably occur

Delivering unwelcome news: scripted preparation recommended; setting vitally important for patient and family (quiet and privacy critical); begin conversation by assessing patient and family’s current level of understanding; in­quire about hopes and expectations; establish realistic goals; distraught states after receiving unwelcome news typ­ically last £5 min (physicians should remain present and allow patients to express emotions); patients often have difficulty processing information after receiving unwelcome news, so supportive individuals should be present to ensure proper communication; avoid technical jargon; attempt to keep patients focused on immediate priorities rather than generalized or long-term facets of treatment; patients should receive specific dates for follow-up and visits; provide interim contact for answering urgent questions (reduces anxiety); unhelpful statements  —  “do you want us to do everything?” (too vague); “it’s time to talk about pulling back,” or “there’s nothing more we can do” (avoid statements implying withdrawing or abandonment; language should describe shifting goals of care toward treating symptoms and providing comfort); truth vs hope  —individuals often rely on denial as primary coping skill; hesitancy to consider poor outcome presents challenges for physicians; terminal illness does not preclude maintain­ing significant sources of hope; hope of achieving realistic goals may genuinely increase survival; false hope  —promoted by practices of nondisclosure (historically encouraged by medical profession); may lead to physical and emotional pain related to undergoing desperate and unproven treatments; creates unnecessary emotional and finan­cial investment by families; faith and optimism about medical system much higher in United States; irrelevant com­ments from specialists may encourage false hope; <5% of patients personally benefit from participation in clinical trials; however, patients typically believe odds of benefitting >50%; false hopelessness  —  physicians may commu­nicate with excessive bluntness when attempting to relieve personal responsibility for poor outcomes (creates sig­nificant hopelessness in patients and families); patients often assume any survival prognostication definitive; families may look to physician to initiate uncomfortable conversations about death

Death: “good death”  —  in surveys, common factors included 1) proper pain and symptom management, 2) clear de­cision making (including patient and family), 3) help anti-cipating what to expect (understanding events reduces anxiety), 4) “completion,” ie, opportunity to conduct life review, resolve conflicts, spend time with loved ones, perform rituals, and share knowledge and insight

Conflicts of Interest in Medicine

Paul F. Mansfield, MD, Professor and Deputy Chair, Department of Surgical Oncology, MD Anderson Cancer Center, University of Texas, Houston

Background: companies, academia, patients, and society all have interest in research outcomes; however, perspec­tives on research vary among these groups (eg, patients may be altruistic [“this may not help me but it may help someone else”], whereas companies have made financial investment and must consider responsiblity to sharehold­ers, and investigators often focused on excitement of discovery); conflicts of interest (COIs) may relate to aca­demic, ethical, personal, leadership, or financial circumstances; historically, discoveries led to fame for researchers and to licensing agreements with pharmaceutical companies for further development of technology; when compa­nies failed to reproduce academic results, researchers lost stature and companies lost investments (impact on aca­demic institution minimal); according to speaker, influence of money has corrupted academia’s integrity-control mechanisms (eg, peer review, promotion, tenure); companies now often provide researchers with equity and direct cash investments; editorial (2006)  —  social science research shows strong impulses to reciprocate associated with receiving even small gifts; individuals often lose objectivity after receiving gifts

Repercussions: Bluestone and Cantekin study  —  in late 1970s, researchers at University of Pittsburgh received $17.4 million grant from National Institutes of Health for prospective randomized double-blind trial of generic amoxicil­lin vs observation; study exhausted funds in 1984 (mostly complete); Bluestone solicited additional $3.5 million from pharmaceutical companies; then authored report which concluded that significant benefit seen with generic amoxicillin or equivalent antimicrobial therapy (Cantekin disagreed); article published in New England Journal of Medicine (NEJM) found clearance of infection in 96% of treated patients at 4 wk (92.5% in control arm [statisti­cally significant difference]); no difference found at 8 wk; Bluestone received $250,000 in honoraria and travel re­imbursement from pharmaceutical companies, whereas Cantekin received nothing; Bayh-Dole Act  —  prior to 1980, academic medical centers relatively separated from industry; Bayh-Dole Act encouraged academic institutions to commercialize discoveries funded with federal research dollars; first draft of COI policy not created until 9 yr after enactment (required researchers to disclose financial holdings and divest from companies sponsoring research); both academia and industry responded to COI policies with outrage; first guidelines released 15 yr after enactment; guidelines required only that institutions create COI policy (rules determined by individual institutions, resulting in broad spectrum of policies and practices); Jessie Gelsinger  —  student who died while enrolled in gene therapy trial in which investigators had significant financial interests (not disclosed to family); led to suspension of many gene therapy programs; as clinical trials rely on trust of participants (lack of trust discourages enrollment), American So­ciety of Gene Therapy issued strong recommendations for preventing COI; other societies, eg, Institute of Medicine (IOM), American Association of Medical Colleges (AAMC), also established guidelines; Bodenheimer (NEJM)  —  in surveys of medical literature, studies supported by industry far more likely to show positive results; 70% of clin­ical trial funding provided by industry; community physicians replacing academic centers as preferred site for clin­ical trials (facilitated by contract research organizations operating more rapidly than institutional review boards); ways in which industry can influence outcomes  —  by declining to conduct post-approval study (eg, rofecoxib [Vioxx]); by designing study in favor of their own product (eg, giving inferior dose of competing product, measur­ing irrelevant surrogate end points); by controlling data; by controlling publication; by ghost writing and guest au­thorship; cyclooxygenase-2 (COX-2) inhibitors  —  reviewed by United States Food and Drug Administration advisory panel in 2005; 9 of 10 panel members who had relevant COIs voted in favor of approval; COX-2 inhibitors received approval despite uncertainty among independent members; professionals with COIs have voted to keep products on market in 88% of cases (approval rate 56% for professionals without COI); for 2 of more concerning drugs, professionals with COIs voted >90% in favor (vs 38% in favor by professionals without COI); Ross analysis (2009)  —  critical review of 250 source documents from 1966 to 2004; 16% of research articles on rofecoxib listed guest authors (13% also ghost written); documentation in lawsuits showed company employees prepared manu­scripts before recruiting academic investigators for publication of clinical trials; 92% of clinical trials reported rela­tionship with drug’s manufacturer, compared to 50% of review articles; AAMC guidelines  —  researchers must report financial interests according to comprehensive and unambiguous policies; disclosure of COI alone insuffi­cient; study participants must be informed of how COIs managed or resolved; all members of institution share equal responsibility for oversight

Solutions: require companies to publicly disclose financial relationships with physicians; dramatically increase pub­lic funding of research; penalize individuals guilty of misusing public trust; recognize human vulnerabilities associ­ated with COIs

Suggested Reading

Back AL et al: Approaching difficult communication tasks in oncology. CA Cancer J Clin 55:164, 2005; Bodenheimer T: Uneasy alliance--clinical investigators and the pharmaceutical industry. N Engl J Med 342:1539, 2000; Cain DM et al: The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Legal Stud 34:1, 2005; Heyland DK et al: Discuss­ing prognosis with patients and their families near the end of life: impact on satisfaction with end-of-life care. Open Med 3:e101, 2009; Jurkovich GJ et al: Giving bad news: the family perspective. J Trauma 48:865, 2000; Lautrette A et al: A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 356:469, 2007; Liaschenko J et al: The "big picture": communicating with families about end-of-life care in intensive care unit. Dimens Crit Care Nurs 28:224, 2009; Mello MM et al: Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 352:2202, 2005; Parks SM, Winter L: End of life decision-making for cancer patients. Prim Care 36:811, 2009; Sise MJ et al: Surgeons' attitudes about communicating with patients and their families. Curr Surg 63:213, 2006; Steinhauser KE et al: In search of a good death: observations of patients, families, and providers. Ann Intern Med 132:825, 2000.