Palliative Gastroenterology, An Issue of Gastroenterology Clinics Vol 35 Issue 1

Gastroenterol Clin N Am 35 (2006) xiii–xiv

GASTROENTEROLOGY CLINICS OF NORTH AMERICA PREFACE

Palliative Gastroenterology

Todd H. Baron, MD, FACP, Geoffrey P. Dunn, MD, FACS Guest Editors

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astroenterologists can expect to encounter a substantial number of patients who have advanced and terminal illnesses. Most of the literature on palliative care medicine is not directed specifically toward gastroenterology. This issue of Gastroenterology Clinics of North America acknowledges cognitive and psychologic barriers that may hamper the practitioner in addressing the needs of this patient population. Although it is not an exhaustive summary of current approaches to palliative care, this issue is a point of reference for practicing gastroenterologists seeking guidance for the management of salient problems encountered in palliative care, the goal of which is to relieve suffering and improve quality of life. Palliative care may be the sole aim of care or offered simultaneously with all other medical treatment. The first article introduces the historic and philosophical background of palliative care, addresses palliative care’s current status in the field of medicine, and concludes by affirming it as a durable philosophy of care that is applicable across a wide spectrum of illnesses encountered in the practice of gastroenterology. Ensuing articles cover basic palliative care skills, such as palliative care assessment, palliative endoscopy, and chronic pain management. The issue concludes with an article on problems encountered in individuals with nontransplantable liver disease. Although much of the material addresses oncologic illness, the principles and many of the interventions covered are applicable to a much wider spectrum of illnesses, such as liver and intestinal failure. Although the field of palliative care has been developed previously outside the field of gastroenterology, gastroenterologists face many of the same 0889-8553/06/$ – see front matter doi:10.1016/j.gtc.2006.01.004

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PREFACE

problems and some problems that are unique to the specialty. There is little doubt that the future will witness a more clearly defined consensus about palliative care by gastroenterologists. It is hoped that this issue will stimulate interest by gastroenterologists in accomplishing this. Palliative care challenges some of our most basic assumptions about the meaning of illness and leads us to ask new questions and discover new problems. As practitioners, we are creating a tradition of service in the relief of suffering that is equally welcome, with our recent accomplishments in eliminating and preventing disease. For a start, we must at least acknowledge the worthiness of a philosophy of care that represents a shift from the elimination of disease to the unconditional relief of suffering and the affirmation of our patients’ lives. Todd H. Baron, MD, FACP Division of Gastroenterology & Hepatology Mayo Clinic College of Medicine Rochester, MN 55905, USA E-mail address: [email protected] Geoffrey P. Dunn, MD, FACS Department of Surgery and Palliative Care Consultation Service Hamot Medical Center 2050 South Shore Drive Erie, PA 16505, USA E-mail address: [email protected]

Gastroenterol Clin N Am 35 (2006) 1–21

GASTROENTEROLOGY CLINICS OF NORTH AMERICA

Palliative Care: A Promising Philosophical Framework for Gastroenterology Geoffrey P. Dunn, MD Department of Surgery and Palliative Care Consultation Service, Hamot Medical Center, 2050 South Shore Drive, Erie, PA 16505, USA

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he decade of the 1990s witnessed the introduction of comprehensive and systematic palliative care in hospital and outpatient settings in North America. Palliative care is defined as interdisciplinary care that aims to relieve suffering and improve the quality of life (QOL) for patients who have advanced illness and their families. It can be offered as the sole aim of care or simultaneously with all other medical treatment. The recognition for the need to this approach reflects a fundamental shift in priorities within the culture of medicine. It was presaged by the widespread and growing popularity of home-based hospice care introduced in the mid 1970s. Public awareness of end-of-life issues was further enhanced by judicial decisions that ruled on an individual’s right to deny medical treatment [1], the debate on physician-assisted suicide, and adverse experiences with end-of-life care [2] that contrasted so sharply with progress in other venues of medical care. Despite this reversal of what seemed to be a conspiracy of silence about death and dying in a highly materialistic culture, ambivalence remains about the role of palliative care in medical treatment. The length of stay in Medicare-certified hospices averages approximately 20 days of a defined benefit period of 6 months, despite increasing acceptance by physicians and consistently favorable experiences of patients and families [3]; and the notion of death as a natural and potentially positive experience in life’s trajectory is only hinted at in a recent policy statement by the National Cancer Institute (NCI), whose stated goal is ‘‘to eliminate suffering and death due to cancer by 2015’’ [4]. Despite this, evidence is accumulating that what patients and their families want is consistent with the primary aims of palliative care. In a study [5] of 475 families members within 2 years of a loss, concerns that mattered included honoring the deceased’s wishes, assistance and support in the home, honesty and directness in communication, continuous access to services, privacy, practical and

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personal care assistance, and to be remembered through ongoing contact after the death. Despite the proliferation of palliative and hospice care programs, patients still give eloquent testimony [6] about their fear of being abandoned by their treating physicians when their disease has progressed to the point at which no further treatment can be given. During this interval of 20 years, much has happened to establish palliative care as a health philosophy that will enrich the practice of gastroenterology, and conversely, developments in gastroenterology have already improved palliative care. Several recent concepts from the field of gastroenterology such as ‘‘the second brain’’ [7] and ‘‘intestinal failure’’ [8] fit well within the conceptual framework of palliative care. This type of synergy will ultimately encourage the application of this philosophy to a much broader spectrum of patients than those who are deemed to be at ‘‘end of life.’’ This broader spectrum of care can be described as palliative gastroenterology. HISTORIC BACKGROUND The term ‘‘palliative care,’’ introduced by Canadian surgeon Balfour Mount, comes from the Latin pallium, meaning ‘‘cloak’’ or ‘‘cover,’’ in the sense of using one to restore dignity and comfort in a situation in which the underlying disease process cannot be altered. Balfour used this description of the hospice concept when he introduced it to the Royal Victoria Hospital, an acute care multispecialty hospital in Montreal. Mount can be credited as the salient pioneer of hospice care in North America as well as being one of the first to bring hospice services into an acute care hospital. The origins of palliative care as now understood in many countries around the world are seen most clearly in the long and productive career of the late Dr. Cicely Saunders [9]. She is acknowledged generally as the founder of the modern hospice movement [9] and mentor to many of the pioneers of palliative care, such as Mount. Dr. Saunders was blessed with robust health, intelligence, a good education, and fate—all for which she more than paid thanks. Like so many notable contributors to the welfare of society, Saunders’ career path began inauspiciously. She was born to a well to do family and studied politics, philosophy, and economics at Oxford University until World War II, when she felt called to care for the ill and wounded as a nurse. She competed training as a nurse, and after the war, she encountered her index patient, Tasma, a Polish refugee who suffered from advanced malignancy. Her encounter with him triggered her life-long work, which ultimately developed a framework of care that now daily restores dignity and comfort to thousands of dying patients. The clinical foundation of her work was her demonstration that terminally ill patients suffering from cancer pain enjoyed improved quality of life with scheduled dosing of morphine. This foundation was based on careful observations and meticulous record keeping during the late 1950s. Now, a half century later, this innovation is still percolating slowly through the medical system, despite the documented efficacy and safety of the practice. It is the patients, families, and health care workers who harbor exaggerated or misplaced fears of

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addiction and respiratory depression and a reluctance to acknowledge progressing illness that account partially for this hesitant acceptance. Saunders’ other seminal contributions to palliative care include her model of ‘‘total pain’’ (discussed below) and the opening of St. Christopher’s Hospice in 1967, which has served as an institutional model of patient care, teaching, and research. St. Christopher’s Hospice was the institutional expression of Saunders’ strong belief that the science of hospice and palliative medicine is matched by the importance of psychologic and spiritual care. Her efforts led to the early assimilation of hospice care into the health care systems of Great Britain and Ireland [10]. By 1987, palliative medicine had become recognized as a medical specialty by the Royal Academy of Medicine. To paraphrase her fellow countryman, Winston Churchill, it would be hard to find another individual in the field of medicine whose personal contributions have had so wide and profound an impact on the care of so many. By the end of the 1970s, hospice was rapidly establishing itself in the United States mostly as an outpatient-based service that offered an alternative to what many believed was an increasingly burdensome, overly medicalized, and institutionalized way of dying. In 1982, the Tax Equity and Fiscal Responsibility Act established the Medicare Hospice Benefit (1983) less than 10 years after the establishment of the first hospice program in the United States. This legislative achievement was a response to popular pressure not an initiative from any medical institution. The grass roots initiative and the lay appeal of hospice in its earlier days may have led to its isolation from mainstream medicine during the 1980s, a period in which there was scant reference to the concept in medical textbooks or in medical school and residency training. Only in the late 1990s, following the study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT) in 1995 [2], the American Board of Internal Medicine’s publication Caring for the Dying in 1996 [11], and the inauguration of the American Medical Association’s Education of Physicians on End-of-Life Care (EPEC) curriculum in 1999 [12], did the concept of hospice and palliative care assume an established role across the continuum of medicine in the United States. In 1996 the American Board of Internal Medicine published its education resource document Caring for the Dying, specifically for the use of program directors and faculty of residency and subspecialty training. In 1997, the Institute of Medicine issued its report Approaching Death: Improving Care at the End of Life [13]. This report concluded that suffering from serious pain and other burdensome symptoms in many dying patients has persisted despite the availability of effective treatments. A much-needed remedy for this state of affairs followed in 1999 with the inauguration of the American Medical Association’s sponsorship of the Education for Physicians on End of Life Care (EPEC) project funded by the Robert Wood Johnson Foundation. Since its initiation in 1999, EPEC has been used to train approximately 1000 physicians, including surgeons, to become instructors of other physicians and allied health care workers on the principles and practices of compassionate and competent palliative and end-of-life care. During the late 1990s,

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philanthropic foundations funded a variety of initiatives that brought the concept of palliative care to the care of selected disease populations (eg, end-stage renal disease [14]) and specializations (surgery [15]). The concepts of palliative care are beginning to be taught in medical schools [16] and postgraduate curricula [17]. The number of articles specifically addressing palliative care in the general medical literature has increased markedly since the time of the SUPPORT in 1995. Kathleen Foley [18], a neurologist and preeminent exponent of pain management and palliative care, observed, ‘‘It is innately human to comfort and provide care to those suffering from cancer, particularly those close to death. Yet what seems self-evident at an individual, personal level has, by and large, not guided policy at the level of institutions in this country’’ [18]. Despite this gloomy assessment, there are indications of change at the institutional level, one of which is reflected in a consensus report co-authored by Dr. Foley. In 1999, a consensus on principles for guiding care at the end of life was endorsed by 17 medical organizations and specializations [19]. As of 2002, the American Board of Surgery identified palliative care as a domain of expected competence for candidates seeking certification. The American College of Surgeons has issued two statements of principles on care at the end of life and palliative care [20,21], in addition to forming a task force for the palliative care education of surgeons [16]. BASIC PRINCIPLES AND MODELS OF SUFFERING Much of what is emerging in the practice and philosophy of palliative care has been strongly influenced by several models of suffering, which is the immediate target of palliative treatment. Complicating this orientation is the belief in some cultures of the positive and redemptive value of suffering. Although the willingness and ability to relieve suffering comprise the initial orientation of palliative caring, equally important affirmative qualities have been identified, such as the restoration and development of an individual’s social, psychologic, and spiritual function. The recognition and relief of suffering are the primary aims of palliative care. Several models of suffering have influenced the philosophy and practice of palliative care. The foremost model was that of Victor Frankl [22], a concentration camp survivor who was a psychiatrist at the time of his captivity. His experience in captivity led ultimately to the development of logotherapy, a form of existential analysis. Frankl’s account of his experiences [22] bears witness that survival is related to the capacity to make sense of suffering, to give suffering a sense of meaning. This is the existential crisis that can be observed in one form or another in all patients encountered in palliative care. Frankl’s belief describes a basic assumption of palliative care: that there must be a purpose to suffering and dying if one believes there is any purpose to existence itself and that choosing one’s attitude in these situations is one freedom that cannot be taken away under any circumstances.

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Frankl’s experience addressed the relationship between suffering and existential issues. Since then, several models of suffering proposed by physicians have made palliative care a more clinically specific construct. In the early 1980s, anticipating the subsequent decades of social and legal debate about autonomy and relief of suffering at end-of-life, Cassell pointed out in a landmark article that physicians tend to deconstruct suffering to its physical dimension while ignoring the psychologic and spiritual pain that accompanies dying. This approach not only fails to relieve suffering but actually compounds it [23]. Cassell [24] defined suffering as arising from the threat to the integrity (wholeness) of the person. He pointed out that ‘‘bodies do not suffer, only persons do.’’ Persons are unique and experience disease differently. A person suffers when the intactness of his or her persona (integrity) is threatened. The elements of an individual’s persona include the individual’s past, present, and future, social role, private life, and a transcendent (spiritual) dimension. It is the presence of the person’s transcendent dimension that permits the separation of death from failure. In Cassell’s framework, suffering is not relieved until the threat to personhood has passed or is diminished. The degree of suffering in Cassell’s and others’ model correlates with the degree of existential threat. According to these models, the intactness of personhood, not the body, is the barometer of health. This conceptual framework resonates with the current popular interest in ‘‘holistic’’ health care and ‘‘treating the whole person.’’ Although the public seems genuinely interested in the holistic model of health care and supports a multimillion-dollar market for ‘‘alternative’’ medicine, the public also is an avid (and generally contented) consumer of health care organized according to the biophysical model. MacDonald [25] points out that the public never fully accepted the biophysical model of cancer because to most nonphysicians of all cultures cancer has always been regarded as an illness with social, psychologic, and spiritual connotations. The biophysical model addresses physical threats to well being or relies heavily on derivatives of it, such as pharmacology to address nonphysical problems. Shifting the goal of care from controlling disease to ameliorating suffering will inevitably present our society with the same task of introspection that has been asked of physicians and surgeons, to allow them to see ‘‘the whole person.’’ Dame Cicely Saunders’ model of ‘‘total pain’’ [26] outlines four cardinal dimensions of pain (physical, socioeconomic, psychologic, and spiritual) that contribute to suffering. Her theory brings a sharper clinical focus to Cassell’s model of suffering by dissecting out specific areas in which threats to personhood may lurk. It was more than coincidence that Saunders had previous professional experience as a nurse, social worker, and physician prior to her description of total pain. The models of Saunders and Cassell could be seen respectively as the anatomy and physiology of palliative care. Brody [27] has described suffering as the anguish felt by the individual as his life, a unique story, is fragmented, preventing its completion and transformation into a transcendent legacy. As the end of life draws nearer, the greater is the potential

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anguish. The implication for the physician is that patients who have progressive, life-limiting illness may be more likely to seek guidance in fixing their ‘‘broken stories’’ than fixing their broken bodies. A more recent and positive conceptualization of suffering and end of life is Byock’s [28] view that dying is a natural phase of life consisting of a series of developmental tasks (see Appendix), with abundant opportunity for rewarding personal growth reminiscent of Erik H. Erikson’s [29] theory of development in which the individual grows as a result of resolving a series of conflicts normally encountered in life. Byock’s four developmental tasks of the dying [28] include:    

Renew a sense of personhood and meaning Bring closure to personal and community relationships Bring closure to worldly affairs Accept the finality of life and the transcendent

Byock’s framework was one of a number from this era that illustrates what previously had seemed so counterintuitive; dying could be conceived as the last phase of a succession of periods in life, each with its own characteristics of health [28]. The wide spectrum of these developmental tasks suggests that the applicability of this model reaches much farther back in the trajectory of an individual’s life than its very last phases. This is particularly important for those living with chronic illnesses punctuated by life-threatening exacerbations, which, if survived, can initiate an irreversible and prolonged decline. PALLIATIVE CARE: OLD HUMANITIES AND NEW SCIENCE All of the models of suffering suggest that a purely biophysical approach to its relief would be a much too limited construct, frustrating to the patient as well as the clinician, unless the patient’s difficulty is an uncomplicated, reversible, physical problem such as a hemorrhoid or nonpathologic fracture. Is it a coincidence that the palliative model of care has arisen at the end of a century during which insights in theoretical physics of the first two decades subsequently found their expression in the natural sciences and then the social and applied sciences? As an analogy, Newtonian physics provided a workable scientific framework for almost all observable, everyday phenomena sufficient to land a man on the moon. However, the Newtonian framework was inadequate to explain phenomena on a subatomic and galactic scale. The extremes of birthing and dying and the extremes of the deeply personal and the broadly social that are encountered in the world of clinical medicine also demand a different guidance than the reductive, compartmentalized, and mechanistic approach that may, nonetheless, solve many problems in daily practice. In addition to the social, psychologic, and spiritual arguments favoring palliative care, there are economic reasons to consider substituting a physical model (disease-directed therapy) with a palliative model of care earlier than in the last 2 months of life. In an increasingly aging population, 28% of all Medicare costs are incurred in the last 2 years of life, of which half is spent

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during the last 2 months of life [30]. The SUPPORT study [2] yields abundant data to show that seriously ill hospitalized patients in the last 6 months of life, in addition to never getting better, were frequently undertreated for pain and their preferences for care were often unknown or even ignored. The average length of stay in hospice during this time was 48 days, during which a third died within 7 days. The difference between the total Medicare expenditures during the last 2 years of life, the increasingly shorter stay in hospice, and the incidence of failed symptom control identified in SUPPORT paints a picture that cries out for a model somewhere between traditional hospice care and curative care. The association of hospice with palliative care has stigmatized palliative care for many health care professionals and laypersons who believe that palliative care is simply a semantic twist on ‘‘hospice,’’ which they may already have oversimplified as only ‘‘preparation for death.’’ In some cases, advocates for hospice care also have indulged in this oversimplification. Hospice care can be classified as a subset of palliative care for patients in the last phases of illness. The physical model of medicine practiced in our death-denying culture has so equated physical death with failure that any acceptance of death as an appropriate outcome of care will be exceedingly difficult. Kass [31] summarizes the limitations of the biophysical model with the following counsel: ‘‘If medicine takes aim at death prevention, rather than at health and relief of suffering, if it regards every death as premature, as a failure of today’s medicine— but avoidable by tomorrow’s—then it is tacitly asserting that its true goal is bodily immortality.. . .Physicians should try to keep their eyes on the main business, restoring and correcting what can be corrected and restored, always acknowledging that death will and must come, that health is a mortal good, and that as embodied beings we are fragile beings that must stop sooner or later, medicine or no medicine’’[31]. It will be some time before leading popular magazines are ready to publish a list of the ‘‘100 Best Hospitals to Die In,’’ despite the fact that the majority of individuals dying natural deaths do so in the hospital setting! A review of the historical evolution of hospice to palliative care demonstrates that both of these philosophies, instead of narrowly focusing on the loss of life, have evolved as forms of social, psychologic, and spiritual health rehabilitation and growth that can occur in the face of ongoing physical decline. Doyle and colleagues [32] summarize this by asserting that ‘‘palliative medicine is concerned with three things: the quality of life, the value of life, and the meaning of life.’’ Seen in this light, it is existence, not death, that is the focus of palliative care. DELIVERY MODELS OF PALLIATIVE CARE There are currently two delivery models of palliative care in the United States medical system: palliative care consultation and hospice services with or without the Medicare Hospice Benefit. Palliative care consultation in hospitals and outpatient settings has became increasingly available since the late 1990s

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because of increasing interest in improved end-of-life care and the favorable impact on patient care made by hospice programs in this country since its introduction in the late 1970s. Palliative care and hospice care share the following features: both provide active total care of patients whose disease is not responsive to curative therapy. Their treatment goal is the best possible quality of life for the patient and family through the relief of pain and other distressing symptoms, the provision of a support system to help patients live as actively as possible, and the provision of support to the patient’s family during the illness and into bereavement. Palliative care can be given concurrently with all other appropriate medical care. A hospice program provides palliative care for terminally ill patients and their families. All hospice programs are palliative care programs, but palliative care is not limited to terminally ill patients. A recent survey [33] has shown that in-hospital palliative care programs in the United States have proliferated rapidly since 2000, numbering approximately 1,027 (25% of hospitals) in 2003. These programs were defined by the American Hospital Association in its annual survey as the provision of specialized medical care, drugs, or therapies for the management of acute or chronic pain and the control of symptoms, which are administered by specially trained physicians and other clinicians, and support services, such as counseling on advanced directives, spiritual care, and social services, to patients who have advanced disease and their families. Palliative care programs meeting this definition were more likely to be offered in larger hospitals, teaching and veterans hospitals, and hospitals designated as American College of Surgeons’ Commission on Cancer-approved cancer hospitals. Hospitals owning their own hospice programs and Catholic-affiliated hospitals were also more likely to report having a palliative care program. In some cases ‘‘palliative care’’ describes programs that specialize primarily in pain management or ethics consultation but do not necessarily offer the full continuum of specialty services (eg, bereavement counseling and pastoral care) offered in Medicare-certified hospice programs. Multiple reviews [34–38] have documented improved pain and nonpain symptom management, improved patient and family satisfaction, reduced critical care unit and hospital stay, decreased in-hospital deaths, and significant cost reductions. Despite this record, many programs have relied heavily on philanthropic donations, grants, cost sharing, and genuine volunteerism by medically trained and laypersons. The criteria for palliative care referral can be generated automatically (ie, any patient staying in an intensive care setting over a defined period of time and any patient with a Karnofsky status of less than 50) or by clinical judgement for any given patient (indications for palliative care consultation are listed in Box 1). Some hospitals have designated units for palliative care, whereas others use a consultative model with or without a designated unit. A high rate of implementation of recommendations from palliative care teams has been noted [39].

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Box 1: Indications for palliative care consultation 

Patient has an illness typified by progressive deterioration and worsening symptoms, often ending fatally.



Patient has limiting or threatening conditions with declining functional status or mental or cognitive function.



Suboptimal control of pain or other distressing symptoms.



Patient and family would benefit from clarification of goals and plan of care or resolution of ethical dilemmas.



Patient or surrogate declines further invasive or curative procedures, preferring comfort-oriented symptom management only.



Patients on medical, surgical, or critical care units who are expected to die imminently or shortly following hospital discharge.



Bereavement support of hospital workers, particularly after the death of a colleague.

Courtesy of Robert A. Milch, MD, Buffalo, NY.

For any individual whose treatment is palliative and no longer life-prolonging, hospice referral from the hospital or outpatient setting should be considered for any individual with a physician-certified prognosis of less than 6 months if the disease pursues its usual course. Any terminal diagnosis is appropriate (Box 2 lists primary hospice services). A common mistaken belief is that a do-not-resuscitate (DNR) order is required for enrollment into a hospice

Box 2: Primary hospice services 

Physical symptom control, such as pain, nausea, dyspnea, and other symptoms



HHA services, such as bathing, dressing, and feeding



Psychosocial counseling for patient and family



Spiritual support for patient and family



Completion of advance directives, wills, and funeral planning



Volunteers



Bereavement services



All drugs related to terminal illness



All durable medical equipment



Therapies such as occupational, physical, nutritional, musica, and massagea



Other services as approved in plan of care: radiation, surgery, chemotherapya, TPNa, transfusiona, and intravenous hydrationa

a

Varies per program. Courtesy of Robert A. Milch, MD, Buffalo, NY.

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program. A DNR requirement is forbidden by Medicare-certified programs because of concerns about coercion and conflict of interest. The presence of a DNR order has been used mistakenly as a marker for other preferences about end of life care [40]. As a practical matter, most patients or surrogates who have had appropriate counseling prior to the election of hospice care are ready to authorize a DNR order. Another inaccurate belief about hospice is the degree of therapeutic nihilism exercised during hospice care, such as the refusal to initiate intravenous (IV) therapy. No treatments are excluded automatically from consideration as long as the criterion for a treatment rests on its ability to achieve the symptom control, regardless of its impact on the underlying disease process. Depending on the resources and size of the hospice program, services will vary and may include the options of IV and total parenteral nutrition (TPN) therapy, chemotherapeutic agents, transfusion, invasive procedures such as gastrointestinal tract stenting, video-assisted thoracoscopy, and open fixation of pathologic fractures. The Medicare-certified hospice team is mandated to include a physician medical director, skilled nursing, a social worker, a pastoral care worker, home health aides, volunteers, and a bereavement program. Box 3 lists Medicare hospice benefits. Although the gastroenterologist may not be in a position to make a referral to palliative care or hospice services, his or her interest and support for these interventions on behalf of a patient will be appreciated deeply by the patient and family, especially if the relationship has been a positive and trusting one. QUALITY OF LIFE MEASUREMENT: THE NEW METRIC OF SUCCESS In any serious illness, questions relating to the impact of medical care on survival and the nature of survival cannot avoid touching on the hopes, fears, and other existential considerations of the individual. These subjective elements shape the individual’s evaluation of the QOL. Because of the importance of

Box 3: Medicare hospice benefit 

Patient elects hospice benefit for terminal illness, signs off Medicare A (hospital)



Primary physician may remain as primary, bills Part B for services



Consultants (eg, medical oncologist or surgeon) bill hospice directly



Patient is recertified as eligible for hospice at the beginning of each benefit period



Benefit periods of 90 days (first benefit period)/90 days (second benefit period)/60 days (each subsequent benefit period) indefinitely, with unlimited length of stay as long as the prognosis continues to meet the Medicare criterion of 6 months or less survival



Patient may revoke hospice benefit at any time

Courtesy of Robert A. Milch, MD, Buffalo, NY.

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the patient’s perceptions in connecting the outer world intervention with the inner reality of the individual, the concepts of palliative care and QOL, although not synonymous, are inseparable. Strong arguments have been made [41] for the scientific reliability of QOL measurement that should reassure skeptics in the medical community that QOL outcomes measurement does not represent a ‘‘soft’’ standard but the ultimate challenge to scientific ability, insight, and compassion. QOL is the endpoint when measuring outcomes in palliative care. The twin goals of palliative care, symptom control and promotion of quality of life, are not measured adequately by the traditional oncologic outcome measurements of mortality and morbidity. Because the patient report is the ‘‘gold standard’’ for measuring the efficacy of palliative intervention, a new science of QOL measurement with psychometric validation is developing rapidly to fill this vacuum (see Rosenfeld elsewhere in this issue). PALLIATIVE CARE AND GASTROENTEROLOGIC ILLNESS: A PERFECT MATCH? Considering the variety of chronic, life-limiting, and highly morbid illnesses encountered in gastroenterologic practice, one wonders how gastroenterology ‘‘slipped by’’ the effect palliative care has made on other specializations [42], which include neurology, nephrology, and surgery. Increased survival from nongastrointestinal comorbidities such as congestive heart failure and dementia will undoubtedly expand the pool of patients appropriate for palliative care presenting to the gastroenterologist. Table 1 [43–51] contains a selection of disease or clinical scenarios likely to be seen by a gastroenterologist, in which the application of the palliative care model would seem appropriate, although as yet untested. Many other entities that are not necessarily imminently lethal (morbid obesity and irritable bowel syndrome) could be added to the list as well. In each of the diseases listed, the salient physical symptoms or distressing signs (eg, bleeding) are listed as possible entry points for more global intervention. The success of total pain management is predicated on treating the most compelling symptom first, usually a physical one. The ultimate, more important existential issues related to closure, purpose in life, and connection beyond the self are addressed more thoroughly if the immediate distractions of physical discomfort are well controlled. Any of the symptoms listed can be seen as the first opportunity to begin the process during which the physician will help the individual and family to hope for the best and plan for the worst. WHERE DOES THE GASTROENTEROLOGIST FIT INTO THE CONTINUUM OF PALLIATIVE CARE? The association of death with failure, culpability, or loss of control poses a potential psychologic barrier to the successful incorporation of a palliative philosophy into the clinical practice of gastroenterology, as it has for other medical disciplines. Other barriers to successful palliative care include denial or fear

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Table 1 Selected clinical problems appropriate for palliative gastroenterology Disease or syndrome Common GI tract symptoms Advanced GI cancer Anorexia/cachexia, bleeding, dysphagia, fistula, nausea, pain, vomiting

Palliative care implications

Interdisciplinary management required for management of malignant GI tract obstruction (surgery, pharmacotherapy, stenting) Total parenteral nutrition of no established benefit for improved survival or quality of life in patients with advanced gastrointestinal malignancy [43] Counseling for limited prognosis, goal framing, and prospective care planning Liver tumors, primary Anorexia/cachexia, ascites, High symptom burden requiring and metastatic bleeding, fever, nausea, interdisciplinary management in vomiting, pain the setting of limited prognosis and often late in a previously existing chronic illness (cirrhosis, previously diagnosed nonhepatic malignancy) Chemotherapy Altered liver function, bleeding, Nausea and vomiting are the constipation, diarrhea, emesis, most distressing side effects of fatigue, nausea, neutropenic chemotherapy [44] enterocolitis, pancreatitis (eg, Poor symptom control and vinca alkaloids), stomatitis diminished quality of life can adversely affect hope and compliance with chemotherapy regimen resulting in decreased survival [45] Severe complications may require discontinuation of diseasedirected therapy and consider hospice referral. Neurologic and Aspiration, cachexia, Significant number of patients myopathic disease constipation, diarrhea, predictably die from swallowing dysphagia dysfunction as a result of neurodegenerative diseases (amotrophic lateralizing sclerosis, Parkinson’s disease) and some forms of muscular dystrophy, usually after placement of a gastrostomy feeding tube. Benefit of gastrostomy tube feeding not established in patients with advanced dementia [46]

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Table 1 (continued) Disease or syndrome

Common GI tract symptoms

Palliative care implications

Chronic pancreatitis

Diabetes, diarrhea, malnutrition, pain, weight loss

Liver failure

Ascites, bleeding, cachexia, encephalopathy, jaundice

Intestinal failure

Depression, diarrhea, fatigue, nutritional support, complications, weight loss

Complicated long-term pain management, often with opioids. Questions of physical dependence versus true addiction and invasive pain management techniques including surgery need to be addressed using an interdisciplinary approach High impact of illness on psychosocial functioning, especially when related to alcoholism Significant psychologic, socioeconomic, and spiritual distress associated with causes of liver failure (ethanol abuse, IV drug abuse) For Childs ‘‘C,’’ prognosis is limited to months, making hospice referral an option Good control of symptoms may up-grade functional status allowing more latitude for therapies Palliative care consultation may facilitate process of liver transplantation [47] Scant literature in reported QOL outcomes for patients eceiving home parenteral nutrition for malignant disease, one study for benign disease reported loss of friends, employment, and depression in 66% of families surveyed [48] Multiple losses stemming from loss of bowel autonomy: loss of normal eating patterns and independence, fear of loss of socioeconomic status, loss of bowel function control. (continued on next page)

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Table 1 (continued) Disease or syndrome

Common GI tract symptoms

Palliative care implications

Inflammatory bowel disease

Anorexia, rectal bleeding, diarrhea, body image, fistula, growth retardation, malaise, malnutrition, nausea, surgical complications, pain, vomiting, weight loss

QOL outcomes are increasingly measured in clinical trials Patients frequently resort to alternative and unconventional therapies [49] and are more likely to with increasing duration of disease [50]. This can be a manifestation of low level of trust or poor symptom control. Occasional patient will have the additional burden of IBD-associated malignancy. Psychosocial impact of disease affects health care utilization [51] Interdisciplinary model of palliative care is patient centered and specific, helpful for selecting among invasive intervention alternatives.

Abbreviations: GI, gastrointestinal; IBD, inflammatory bowel disease.

of death, lack of training in the techniques of communication and symptom control, and, in some cases, indifference. Another potential barrier to the inclusion of a comprehensive philosophy of palliation in the framework of medicine is deeply rooted prejudice directed against the ‘‘soft’’ behavioral and social sciences (not to mention the humanities), which are deemed ‘‘less valid’’ than the physical sciences. In the face of these barriers, it would represent a substantial leap for a gastroenterologist to accept palliation as an affirmative process of ameliorating suffering that takes an equal if not greater priority to the intent to cure. Perhaps gastroenterologists can be inspired to accept the construct of palliative care by the recent progress of their professional cousins, the surgeons! In October 2003, the American College of Surgeons’ Task Force on Professionalism published the American College of Surgeons’ Code of Professional Conduct [52]. In its commentary, the Task Force wrote, "We singled out terminally ill patients as worthy of specific mention. Most surgeons are uncomfortable with death; it is an outcome that might be equate with defeat. Many surgeons are also uncomfortable with the transition from curative to palliative care. Effective palliation at these difficult times obligates sensitive discussion with patients and their families. Surgeons must accept a pivotal role in facilitating this therapeutic transition, for both patients and the healthcare team’’ [53].

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Palliative gastroenterology, similar to surgical palliative care, is more a matter of rediscovery or renaming much of the daily experience most gastroenterologists have with patients suffering from advanced and critical illness than the assimilation of radically new concepts. The pragmatic temperament of those physicians who perform procedures facilitates their endorsement of any new technique or concept that effectively yields results, in this case, the relief of suffering. There is a wide spectrum of opportunity for the gastroenterologist to participate in palliative care, depending on his or her time, abilities, and degree of interest. Deciding ‘‘how involved should I be in the palliative care of a patient?’’ is a personal one, but at the very least the gastroenterologist should be aware of the indications for referral and be willing to facilitate referral to the appropriate individuals or agencies in a timely and supportive manner. Years of faithful service by a physician can be quickly forgotten by a patient and family if there is footdragging by the physician about an appropriate hospice or palliative care referral. There are several levels of involvement in palliative care beyond the primary level of engagement expected of all physicians (Box 4).

EDUCATIONAL RESOURCES The palliative care movement in the United States during the late 1990s and early 2000s has been catalyzed by the availability of several well-designed and continuously updated Web sites, among which is the End of Life/Palliative Education Resource Center (EPERC) Web site (www.eperc.mcw.edu). The purpose of EPERC is to share educational resource material among the community of health professional educators involved in palliative care education. The site offers ‘‘Fast Facts,’’ which consists of one-page peer-reviewed outlines of key information on important end-of-life clinical topics for end-oflife educators and clinicians, down-loadable educational materials, suggested articles, and links to clinical and educational resource centers. The Center for Advance Palliative Care (CAPC) has a useful Web site (www.capc.org) for surgeons who may be involved in organizing hospital-based palliative care programs. The CAPC, an initiative supported by the Robert Wood Johnson Foundation and assisted by the Mount Sinai School of Medicine in New York, provides health care professionals with the tools, training, and technical assistance necessary to start and sustain successful palliative care programs in hospitals and other health care settings. Through its Web site, the CAPC provides management training seminars, audio conferences, and other offerings, and a core curriculum for programs in planning and early stages of development. The CAPC also provides information on palliative care to hospitals, clinicians, policymakers, payers, and researchers. Other Web sites and organizations of interest include the National Hospice and Palliative Care Organization (www.nhpco.org), the Robert Wood Johnson Office of Promoting Excellence in End-of-Life Care (www.promotingexcellence.org), and the American Academy of Hospice and Palliative Medicine (www.aahpm.org).

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Box 4: Levels of the gastroenterologist’s involvement in palliative care Level 1: the gastroenterologist Is familiar with basic principles of palliative care as endorsed by specialty organizations and examining boards and has met palliative and end-of-life care CME requirements where mandated (eg, California). Is competent in the management of acute and uncomplicated chronic pain, major nonpain symptoms, and the communication of bad news. Can recognize the syndrome of imminent demise. Refers appropriately to palliative care and hospice services. Level 2 (level 1 plus. . .): the gastroenterologist Participates in palliative care indirectly or directly by participation in ethics, patient care, critical care, and pharmacy committees. Promotes interest in palliative care by inviting grand rounds speakers, supports educational initiatives, and supports palliative care consultants and services. Level 3 (level 1 plus. . .): the gastroenterologist Active or retired, participates in hospice or palliative care interdisciplinary teams, as either paid staff or a volunteer. Is certified by the American Academy of Hospice and Palliative Medicine (or American Board of Medical Specialties when available). Level 4 (level 1 plus. . .): the gastroenterologist Is active in the practice of gastroenterology, the primary focus of which is palliative care education, research, or direct patient care (eg, palliative gastroenterology specialist).

CERTIFICATION IN PALLIATIVE AND HOSPICE CARE For gastroenterologists who wish to pursue palliative care in more depth, either as a primary focus of practice or as an adjunct to their primary specialization, the option off pursuing certification by the American Board of Hospice and Palliative Medicine (ABHPM) has been available since 1996. Candidates are required to hold an American Board of Medical Specialties (ABMS)-approved primary Board Certification, certified status for at least 2 years in a primary medical specialty, have had 2 years’ practice experience beyond residency or fellowship, 2 years’ experience of interdisciplinary team work with a hospice or palliative care program, physician and nonphysician professional references, and evidence of direct participation in the care of at least fifty terminally ill patients [54]. The ABHPM is not yet affiliated with the American Board of Medical Specialties, although an application to the ABMS to recognize palliative medicine as a subspecialty has been submitted by the American Board of Internal Medicine, and a decision regarding

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the application will be made in September 2006. To date, approximately 1900 physicians have been certified by the ABHPM, including specialists in family medicine, geriatrics, radiation oncology, surgery, anesthesia, psychiatry, and gastroenterology, among others. If palliative medicine becomes an ABMSaccredited subspecialty, after the initial period of ‘‘grandfathering,’’ only individuals who have completed an Accreditation Council for Graduate Medical Education-accredited fellowship in Hospice and Palliative Medicine will be able to sit for the certifying examination. Currently, there are 17 accredited palliative medicine fellowships in the United States [55]. Information about the ABHPM and the status of ABMS specialty certification in hospice and palliative care can be obtained at www.abhpm.org. FUTURE OF PALLIATIVE GASTROENTEROLOGY The future of palliative care research lies in the consensus of physicians and their leadership that the concept of palliative care is valid and essential to all practitioners. The conversion of rapidly fatal illnesses to chronic illnesses in an already aging population should provide some impetus to the acceptance of functional and QOL outcomes as equally valid as survival and diseasefree intervals. The existing barriers to this acceptance are formidable and include economic and political obstacles such as access to research funding. Only 0.9% of the 1999 NCI budget went to palliative and hospice care research [56], despite the fact that a significant number of those diagnosed with cancer will succumb to it, still have it, or have permanent sequelae of its treatment at the time of death. The concept of palliative gastroenterology is still too new to identify research funding for nononcologic illnesses such as inflammatory bowel disease or liver failure. Other barriers include the unique ethical concerns related to research in a highly vulnerable population and little collaborative experience between gastroenterologists and palliative care professionals. SUMMARY Martin Adson, a surgeon, completes the Introduction to the book Liver Metastases: Biology, Diagnosis, and Treatment [57] with an eloquent moral charge to all physicians and surgeons that summarizes the reason, the method, and the reward for the palliation of suffering caused by metastatic cancer. His words apply to all other incurable conditions and those treating them: ‘‘The common denominators of all metastatic cancers are pain, fear, and loss and the common denominator of involved physicians is concern. Neither these terrifying components of cancer nor the efforts of defenders can be measured or controlled scientifically, but disregard of this reciprocal relationship by physicians and surgeons is a denial of moral obligation. Abandonment in the context of medical practice is a form of spiritual malpractice. There is no specific formula for the relationship required when science is found wanting, but palliation of suffering of this kind must begin with acknowledgement. This

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involves. . .a capacity for affection and willingness to share one’s importance and strength with the person whose importance is threatened by the cancer that you have been trained to treat.’’ APPENDIX: FAST FACT CONCEPT NO. 084: SWALLOW STUDIES, TUBE FEEDING, AND THE DEATH SPIRALa The reflex by families and doctors to provide nutrition for the patient who cannot swallow is overwhelming. It is now common practice for such patients to undergo a swallowing evaluation and, if the patient ‘‘fails,’’ to move forward with feeding tube placement (nasogastric, jejeunogastric). Data suggest that placement of feeding tubes has an in-hospital mortality of 15%–25%, and one-year mortality of 60%. Not surprisingly, predictors of early mortality include: high age, CNS [central nervous system] pathology (CVA [cardiovascular accident], dementia), cancer, except early stage head/neck cancer, disorientation, and low albumin. The clinical scenario, the tube feeding death spiral, typically goes like this: 1. Hospital admission for complication of ‘‘brain failure’’ or other predictable end organ failure due to primary illnesses (eg, urosepsis in setting of advanced dementia) 2. Inability to swallow and/or direct evidence of aspiration and/or weight loss with little oral intake 3. Swallowing evaluation followed by a recommendation for nonoral feeding due to either aspiration or inadequate intake 4. Feeding tube placed leading to increasing ‘‘agitation’’ leading to patientremoval or dislodgement of feeding tube 5. Re-insertion of feeding tube; hand and/or chest restraints placed 6. Aspiration pneumonia 7. Intravenous antibiotics and pulse oximetry 8. Repeat of [steps] 4 through 6 one or more times 9. Family conference 10. Death

Note: at [the Web author’s] institution, the finding of a dying patient with a feeding tube, restraints and pulse oximetry, is known as Weissman’s triad. Suggestions include: 1. Recognize that the inability to maintain nutrition through the oral route, in the setting of a chronic life-limiting illness and declining function, is usually a marker of the dying process. Discuss this with families as a means to a larger discussion of overall end of life goals. 2. Ensure that your colleagues are aware of the key data and recommendations on tube feedings (see below; also see Fast Fact no. 10: Tube Feed or Not Tube Feed).

a

Adapted from Weissman, DE. Swallow studies, tube feeding and the death spiral. Fast Fact and Concept no. 85. 2003. End-of-Life Physician Education Resource Center [Web site]. Available at: www.eperc.mcw.edu.; with permission.

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3. Ensure there is true informed consent prior to feeding tube insertion; families must be given alternatives (eg, hand feeding, comfort measures) along with discussion of goals and prognosis. 4. Assist families by providing information and a clear recommendation for or against the use of a feeding tube. Families who decide against feeding tube placement can be expected to second-guess their decision and will need continued team support. 5. If a feeding tube is placed, establish clear goals (eg, improved function) and establish a timeline for re-evaluation to determine if goals are being met (typically 2–4 weeks).

Bibliography Finucane TE, et al. Tube feeding in patients with advanced dementia. J Gen Int Med 1999;282: 1365–9. Finucane TE, Bynum JP. Use of tube feeding to prevent aspiration pneumonia. Lancet 1996;348: 1421–4. Cowen ME, et al. Survival estimates for patients with abnormal swallowing studies. JGIM 1997;12:88–94. Rabeneck L, et al. Long term outcomes of patients receiving percutaneous endoscopic gastrostomy tubes. JGIM 1996;11:287–93. Grant MD, et al. Gastrostomy placement and mortality among hospitalized Medicare beneficiaries. JAMA 1998;279:1973–6.

References [1] Cruzan v Director, Missouri Department of Health, 497 DS 261 (1990). [2] The SUPPORT Clinical Investigators. A controlled trial to improve care for seriously ill hospitalized patients: the study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). JAMA 1995;274(20):1591–8. [3] NHPCO data. Available at: www.hhpco.org/files/public/facts_figures_for2004data.pdf. Accessed January 21, 2006. [4] von Eschenbach AC. Realistic goal: end suffering, death from cancer by 2015. USA Today January 21, 2004;A15 [5] Hickman SE, Tolle S, Tilden V, et al. The Oregon report card: improving care of the dying. 1999. Available at: www.ohsu.edu/ethics. Accessed January 21, 2006. [6] Brody JE. A doctor’s duty, when death is inevitable. The New York Times; section E: August 10, 2004. p. 7. [7] Gershon MD. The second brain. New York: Harper Collins; 1998. [8] Nightingale J, editor. Intestinal failure. London: Greenwich Medical Media; 2001. p. xxix–xxxx. [9] Saxon W. Cicely Saunders dies at 87; reshaped end-of-life care. New York Times; section A: August 4, 2005. p. 17. [10] Schonwetter RS, editor. Hospice and palliative medicine: core curriculum and review syllabus. Dubuque (IA): Kendall/Hunt Publishing Company; 1999. p. 9. [11] American Board of Internal Medicine Committee on Evaluation of Clinical Competence: Caring for the dying: identification and promotion of physician competency. Philadelphia: American Board of Internal Medicine; 1996 [educational resource document]. [12] Emmanuel LL, von Gunten CF, Ferris FD, editors. The EPEC curriculum: education for physicians on end -of-life care. The EPEC project. 1999. Available at: www.EPEC.net. Accessed December 22, 2005. [13] Field MJ, Cassel CK, editors. Approaching death: improving care at the end of life: report by the Committee on Care at the End of Life. Washington (DC): National Academy Press; 1997.

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[14] Moss AH, Campbell B, Cohen LM, et al. End Stage renal disease workgroup. Available at: www.promotingexcellence.org/esrd/indexv2.html. Accessed December 22, 2005. [15] Surgeons’ Palliative Care Workgroup. Report to the field. J Am Coll Surg 2003;197(4): 661–86. [16] Billings JA, Block S. Palliative care in undergraduate medical education: status report and future directions. JAMA 1997;278(9):233–8. [17] Weissman DE, Mullan PB, Ambuel B, et al. End-of-life curriculum reform: outcomes and impact in a follow-up study of internal medicine residency programs. J Palliat Med 2002;5(4): 497–506. [18] Foley KM. Preface. In: Foley KM, Gelband H, editors. Improving palliative care for cancersummary and recommendations. Washington (DC): National Academy Press; 2001. p. ix. [19] Cassel C, Foley K. Principles for care at the end of life: an emerging consensus among the specialties of medicine. Report sponsored by the Milbank Memorial Fund. December 1999. Available at: http://www.milbank.org. Accessed December 22, 2005. [20] American College of Surgeons. Principles guiding care at end of life. Bull Am Coll Surg 1998;83:46. [21] American College of Surgeons. Principles of palliative care. Bull Am Coll Surg 2005;90(8): 34–5. [22] Frankl VE. Man’s search for meaning. New York: Washington Square Press; 1985. [23] Cassell EJ. The nature of suffering and the goals of medicine. New Engl J Med 1982;306(11):639–45. [24] Cassell EJ. The nature of suffering and the goals of medicine. New York: Oxford University Press; 1991. p. 33–4. [25] MacDonald N. Palliative medicine and modern cancer care. In: Doyle D, Hanks G, Cherny NI, et al, editors. Oxford textbook of palliative medicine. 3rd edition. Oxford (UK): Oxford University Press; 2004. p. 24. [26] Saunders CM. The challenge of terminal care. In: Symington T, Carter RL, editors. Scientific foundations of oncology. London: Heinemann; 1976. p. 673–9. [27] Brody H. My story is broken; can you help me fix it? medical ethics and joint construction of narrative. Lit Med 1994;13(1):79–92. [28] Byock IR. The nature of suffering and the nature of opportunity at the end of life. Clin Geriatr Med 1996;12(2):237–52. [29] Erikson EH. Identity and the life cycle. New York: WW Norton & Co, Inc.; 1980. p. 1–187. [30] National Hospice Organization. Hospice fact sheet. Arlington (VA): National Hospice Organization; 2001. [31] Kass LR. Ethical dilemmas in the care of the ill. What is the patient’s good? JAMA 1980;244: 1947. [32] Doyle D, Hanks G, Cherny NI, et al, editors. Introduction. In: Doyle D, Hanks G, Cherny NI, et al, editors. Oxford textbook of palliative medicine. 3rd edition. Oxford (UK): Oxford University Press; 2004. p. 4. [33] Morrison SR, Maroney-Galin C, Kralovec PD, et al. The growth of palliative care programs in United States hospitals. J Palliat Med 2005;8(6):1127–34. [34] Morrison S, Meier DE. Palliative care. N Engl J Med 2004;350:2582–90. [35] Elsayem A, Swint K, Fisch M, et al. Palliative care inpatient service in a comprehensive cancer center: clinical and financial outcomes. J Clin Oncol 2004;22:2008–14. [36] Meier DE. Palliative care in hospitals: making the case. New York: Center to Advance Palliative Care; 2002. [37] Higginson IJ, Finlay IG, Goodwin DM, et al. Do hospital-based palliative teams improve care for patients or families at the end of life? J Pain Symptom Manage 2002;23: 96–106. [38] Campbell ML, Guzman JA. Impact of a proactive approach to improve end-of-life care in a medical ICU. Chest 2003;123:266–71.

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[39] Manfredi PL, Morrison RS, Morris J, et al. Palliative care consultations: how do they impact the care of hospitalized patients? J Pain Symptom Manage 2000;20(3):166–73. [40] Beach MC, Morrison RS. The effect of do-not-resuscitate orders on physician decisionmaking. J Am Geriatr Soc 2002;50:2057–61. [41] Koller M, Nies C, Lorenz W. Quality of life issues in palliative surgery. In: Dunn GP, Johnson AG, editors. Surgical palliative care. Oxford (UK): Oxford University Press; 2004. p. 94–111. [42] Robert Wood Johnson Foundation, Office of Promoting Excellence in End-of-Life Care. Available at: http://www.promotingexcellence.org/esrd/indexv2.html. Accessed December 22, 2005. [43] Jeejeebhoy KN. Parenteral nutrition in gastrointestinal disease. In: Irvine EJ, Hunt RH, editors. Evidence-based gastroenterology. Hamilton (Ont, Canada): BC Decker Inc.; 2001. p. 358. [44] Coates A, Abraham S, Kaye SB, et al. On the receiving end: patient perception of the sideeffects of cancer chemotherapy. European Journal of Cancer and Clinical Oncology 1983;19:203–8. [45] Fischbach W. Side-effects of chemotherapy on the gastrointestinal tract: symptoms, grade and classification. In: Staritz M, Adler G, Schmiegel W, et al, editors. Proceedings of the Falk Workshop, Oct. 11, 2002: side-effects of cancer chemotherapy on the gastrointestinal tract: physiology, prophylaxis, and therapy. Dordrecht (Netherlands): Kluwer Academic Publishers; 2003. [46] Finucane TE, Christmas C, Travis K. Tube feeding in patients with advanced dementia: a review of the evidence. JAMA 1999;282(14):1365–70. [47] Molmenti EP, Dunn GP. Transplantation and palliative care: the convergence of two seemingly opposite realities. Surg Clin North Am 2005;85:373–82. [48] Smith C. Quality of life in long term total parenteral nutrition patients and their family caregivers. JPEN J Parenter Enteral Nutr 1993;17:501–6. [49] Hilsden RJ, Verhoef MJ. Complementary medicine use by patients with inflammatory bowel disease. Am J Gastroenterol 1998;93:697–701. [50] Moser G, Tillinger W, Sachs G, et al. Relationship between the use of unconventional therapies and disease-related concerns: a study of patients with inflammatory bowel disease. J Psychosom Res 1996;4:318–23. [51] Turnbull GK, Vallis TM. Quality of life in inflammatory bowel disease: the interaction of disease with psychosocial function. Am J Gastroenterol 1995;90:1450–4. [52] American College of Surgeons Task Force on Professionalism. Code of professional conduct. J Am Coll Surg 2003;197(4):603–4. [53] American College of Surgeons Task Force on Professionalism. Professionalism in surgery. J Am Coll Surg 2003;197(4):605–8. [54] American Board of Hospice and Palliative Medicine. Certification Eligibility Requirements 2006. Available at: www.abhpm.org/gfxc_13.aspx. Accessed January 22, 2006. [55] American Board of Hospice and Palliative Medicine [Web site]. Available at: www.abhpm. org. Accessed December 20, 2005. [56] Foley KM. Improving palliative care for cancer- summary and recommendations. Washington (DC): National Academy Press; 2001 [pamphlet]. [57] Garen OJ, Geraghty JG, Nagorney DM. Liver metastases: biology, diagnosis, and treatment. London: Springer-Verlag, Ltd; 1998. p. 1–5.

Gastroenterol Clin N Am 35 (2006) 23–39

GASTROENTEROLOGY CLINICS OF NORTH AMERICA

Palliative Care Assessment: What Are We Looking For? Kenneth Rosenfeld, MD Veterans Integrated Palliative Program, Greater Los Angeles Veterans Affairs Healthcare System, 11301 Wilshire Boulevard, Los Angeles, CA 90037, USA

G

astroenterologists are providing both specialty and primary care to an increasing number of patients who have advanced, progressive illness, who are near the end of life. Dramatic increases in palliative endoscopic procedures, including placement of percutaneous endoscopic gastrostomy tubes and stenting of obstructions of the upper and lower digestive tract, have fueled growth in the palliative gastrointestinal (GI) population, making the gastroenterologist a frequently visited or even the primary physician for many patients. These patients present unique challenges to decision making, symptom management, and psychosocial assessment, yet few gastroenterologists have received training in core competencies required to provide highquality care to patients who have palliative needs. To fulfill one’s professional responsibility, the GI specialist needs to gain, at a minimum, a set of core competencies in palliative assessment and management directed to patients who have advanced illness. This article provides an overview of palliative care assessment directed toward the gastroenterologic specialist. First, it presents an evidence-based conceptual model of high-quality end-of-life care to serve as the basis for a palliative assessment strategy. An approach to assessment is then presented, recognizing that comprehensive palliative assessment ideally requires participation of an interdisciplinary team (historically a physician nurse, social worker, and chaplain). The physician’s role as team leader often includes screening for problems in each palliative domain, referring to appropriate team members for a more detailed assessment, and integrating data to collaboratively (with the team, patient and caregivers) develop a management plan. Because the relief of suffering and the cure of disease are dual obligations of the medical profession [1], palliative care provides possibilities for benefiting patients and caregivers when cure is no longer realistic.

E-mail address: [email protected] 0889-8553/06/$ – see front matter doi:10.1016/j.gtc.2005.12.002

ª 2006 Elsevier Inc. All rights reserved. gastro.theclinics.com

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CONCEPTUALIZING THE PALLIATIVE CARE ASSESSMENT Palliative care is defined by the World Health Organization (WHO) as ‘‘the active total care of patients whose disease is not responsive to curative treatment. Control of pain, other symptoms, and psychologic, social, and spiritual problems is paramount. The goal of palliative care is achievement of the best quality of life for patients and their families’’ [2]. The wide scope of the WHO definition suggests that palliative care addresses a broader range of dimensions than the traditional ‘‘curative’’ model, in which maximizing survival duration is the primary goal of assessment and treatment burden, venue of care, and other quality of life concerns are addressed secondarily, if at all. Over the past decade, research and expert opinion have clarified the highly subjective experience of approaching life’s end and have defined areas important to patients and families that should be included in the palliative assessment. In a focus group study of chronically ill individuals, Singer and colleagues [3] identified five end-of-life quality domains, including adequate pain and symptom management, avoidance of inappropriate prolongation of dying, achievement of a sense of control, relief of burden, and strengthening relationships with loved ones. This and other qualitative [4] research as well as the opinions of expert groups [5,6] suggest that palliative assessment address the following components (Box 1): (1) physical symptoms and functioning; (2) emotional and spiritual concerns; (3) personal history; (4) social support and caregiver needs; (5) goals of care and advance care planning; and (6) anticipatory issues, including preferred terminal care setting and after death concerns. Adding to this framework a few standard assessment elements (clinical summary, medications, physical examination, and laboratory evaluation) provides the physician with a comprehensive and patient-centered strategy. CLINICAL SUMMARY The first step in palliative assessment entails a review of the patient’s illness history, including the primary life-limiting illness and other concurrent illnesses Box 1: A suggested palliative assessment approach 1. Clinical summary 2. Physical symptoms and functioning 3. Psychological and spiritual functioning 4. Goals of care/advance care planning 5. Social support and caregiver needs 6. Anticipatory concerns (care setting and afterdeath) 7. Medications 8. Physical examination 9. Laboratory 10. Summary and recommendations

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with relevance to the primary illness or its treatment. The clinical summary includes a review of the patient’s treatment course, including the response to treatment, side effects and toxicities, and treatment complications. The clinical summary provides important information (for survival and functioning) which will assist the physician in discussing goals of care and planning treatment. It also gives the physician clues as to the types of symptoms to be assessed, based on illness characteristics, clinical course, and treatment toxicities. Information regarding issues such as the recency of the diagnosis or treatment successes or setbacks also helps the physician to anticipate the types of emotional and spiritual challenges the patient may be dealing with and the factors the patient may be weighing in treatment decision making. For example, a patient who has undergone and survived intubation for respiratory failure is likely to view a discussion regarding future use of a ventilator very differently than one who has never been on a ventilator. Entering the assessment with as detailed an understanding as possible of the patient’s previous medical care facilitates sensitive and comprehensive history taking and promotes patient-centered decision making. PHYSICAL SYMPTOMS AND FUNCTIONING Physical problems, in the form of symptoms and functional decline, are virtually universal in patients who have advanced illness. In a study [7] of 275 consecutive patients who had cancer, pain, fatigue, anorexia, nausea, constipation, and confusion was each reported in 60% to 90% of patients. These and other symptoms are sources of distress for both patients and caregivers and have a major impact on quality of life. Thorough evaluation of physical symptoms falls squarely within the responsibility of the physician. Although, often thought of as an expected and unavoidable part of advanced illness, prompt recognition of pain and other distressing symptoms can lead to effective management in the vast majority of cases [8]. Symptoms may result from the disease process itself or from toxicities of disease treatment; diseases may cause symptoms directly through damage to organs (as in cirrhosis), by compression or invasion of adjacent structures (eg, cancer), through the release of compounds by a diseased organ (eg, paraneoplastic syndromes), from the body’s own defenses (eg, tumor necrosis factor and interleukins in infection), or from metabolic derangements caused by the failure of diseased organs (eg, hyperammonia in hepatic failure). Alternatively, symptoms can be caused by adverse effects of treatments used to treat the underlying disease, such as radiation therapy, chemotherapy, and medications. Importantly, symptoms in advanced disease usually reflect a complex interaction of pathophysiologic processes, emotional factors, and spiritual concerns aptly labeled ‘‘total pain’’ [9]. The concept of total pain has important implications for the provider because optimal symptom management often requires attention to each contributing factor. A list of common symptoms is provided in Box 2.

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Box 2: Common symptoms near the end of life Pain Fatigue Anorexia Cachexia/weight loss Nausea/vomiting Constipation Edema Dyspnea Pressure sores Insomnia Confusion

When a symptom is present, a more detailed history permits the physician to localize its likely cause and to provide a baseline of symptom severity through which treatment effectiveness may be monitored. Clarifying a symptom’s underlying cause is important because symptom management differs based on its cause. For instance, nausea from partial gastric outlet obstruction caused by an enlarged liver is managed differently from nausea experienced as a side effect of opioids. Finally, symptom assessment should also elicit all necessary information to develop an immediate management plan. Even in situations in which further diagnostic testing is indicated, prompt treatment of symptoms should always be prioritized. The evaluation of pain provides a good example of how to approach symptom assessment in general. As in other symptoms, prompt and thorough assessment of pain is essential because of the prevalence of pain (60%–90% in those who have advanced cancer [7]), its impact on quality of life [10], and its ready response in most cases to treatment based on easily applied guidelines [9]. Nevertheless, studies reproducibly demonstrate that pain is undermanaged, even in established oncology settings where pain should be anticipated [11]. Pain assessment should elicit information necessary to initiate management in the immediate-term and to identify likely causative factors, which can help with longer term management. The WHO cancer pain management ‘‘ladder’’ proposes initial management based on the severity of pain rather than its precise cause, so immediate management-directed evaluation includes assessment of pain severity, frequency, and response to previously attempted treatments. Pain severity can be assessed through a number of approaches [12], most commonly by the 0-to-10 point scale now adopted widely as the ‘‘fifth vital sign.’’ Pain frequency, whether continuous or intermittent throughout the day, aids in

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decisions about whether to prescribe short- or long-acting analgesics and in round-the-clock versus as-needed dosing decisions. In assessing the response to treatment, it is helpful to identify the patient’s pain level and intensity before the analgesic is taken, once the medication has reached its full effect (typically after 1 hour for immediate-release medications). Additional questions that can help to localize the cause of pain include its location, quality (eg, aching, stabbing, or sharp, which is characteristic of nociceptive pain, or burning, tingling, or lancinating, which is characteristic of neuropathic pain) radiation, and precipitating and relieving factors. It is helpful to inquire about the pain’s impact on patient mood and functioning, which provides additional information relevant to the patient’s perspective on the pain. The approach described above for pain assessment can be adapted to the full range of common symptoms, recognizing that assessment of any symptom requires a basic understanding of symptom-specific pathophysiology and its relationship to symptom manifestations and management. Numerous screening tools have been developed to identify the presence and intensity of a range of common symptoms. The Edmonton Symptom Assessment Scale [13] and the Condensed Memorial Symptom Assessment Scale [14], are particularly easy to use. An assessment of physical functioning is integral to palliative management because function affects prognosis [15], the appropriateness of certain treatments such as chemotherapy, and the patient’s care needs and social interactions. Functional assessment may elicit the patient’s ability to perform basic activities of daily living such as those defined by Katz and colleagues [16] (toileting, bathing, dressing, continence, transfers, and feeding) and also more complex ‘‘instrumental’’ activities of daily living, believed to be required for independent living (eg, preparing meals, managing finances, shopping for groceries, using a telephone, and performing housework) [17]. In addition to task-based function ratings, observer-rated performance scales are also used widely, most notably the Eastern Cooperative Oncology Group Performance Scale [18], a 6-point scale (scored 0 to 5) in which higher numbers indicate more severe functional impairment, and the Karnofsky Performance Scale [19], an 11-point scale (scored from 100 to 0) with higher numbers signifying better performance status (Table 1). The Karnofsky scale has recently been modified to the Palliative Performance Scale [20], which includes five palliative-focused domains, including activity level, ambulation, self-care, intake, and level of consciousness. Serial application of these scales can help the provider to identify and anticipate a patient’s likely care needs as the disease progresses. PSYCHOLOGIC AND SPIRITUAL FUNCTIONING Life-limiting illnesses create challenges that tax an individual’s inner strength but also provides an opportunity for personal growth near the end of life [21]. In contrast with contemporary medicine which focuses its attention on the molecular mechanisms, genetics, and pathophysiology of disease, palliative care inquires into the patient’s experience of illness, which is an amalgam of the

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Table 1 Commonly-used observer-rated performance status measures ECOG 0 1 2 3 4 5

Fully active, no restrictions on activity Restricted in strenuous activity but able to carry on less vigorous activity Ambulatory, able to perform self-care; out of bed >50% of day Limited self-care; in bed >50% of waking hours Disabled; no self-care; confined to bed or chair Dead

Karnofsky 100 90 80 70 60 50 40 30 20 10

Normal, no evidence of disease Normal activity, minor symptoms of disease Normal activity with effort: some symptoms of disease Cares of self: unable to carry on normal activity or active work Requires occasional assistance but is able to care for needs Requires considerable assistance and frequent medical care Disabled: requires special care and assistance Severely disabled: hospitalization is indicated, death not imminent Very sick, hospitalization necessary: active treatment necessary Moribund, fatal processes progressing rapidly

Data from Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969;9(3):179–86; Verger E, Salamero M, Conill C. Can Karnofsky performance status be transformed to the Eastern Cooperative Oncology Group scoring scale and vice versa? Eur J Cancer 1992;28A(8-9):1328–30; with permission.

disease state and the patient’s psychologic and spiritual makeup. The illness experience includes a patient’s education, religious or spiritual grounding, employment and hobbies, family relationships, experiences with illness in self and loved ones, and other elements that shape the ‘‘person’’ behind the ‘‘patient.’’ Given the illness experience’s influence on a patients’ goals of care and treatment preferences, symptoms, and coping abilities, the physician’s grasp of these elements can facilitate treatment decision making, symptom management, and planning for terminal care strengthening the alliance between physician and patient. Although psychologic and spiritual assessment may not be the physician’s sole responsibility within the interdisciplinary team, the physician can, during the initial palliative evaluation, gain a basic understanding of the core elements of the patient’s personal history. An astute physician can implicitly weave an assessment of the patient’s cognitive state (ie, presence of delirium or dementia), emotional functioning, and spiritual well being into the patient interview by attending to clues of attention, affect, and distress. Such implicit evaluation can prompt a more thorough evaluation if areas of concern are identified. Given the intense personal and interpersonal challenges patients who have advanced illness face [1], the contributions of these elements to patients’ overall care cannot be overstated.

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Cognitive dysfunction occurs at a high rate during the advanced phase of illness [22] and is often caused by remediable factors. Screening for cognitive function is an important part of the palliative evaluation with the dual goals of detecting cognitive dysfunction, if present, and forming a baseline in case cognitive impairment develops later in the patient’s clinical course. The screening tool most commonly used in clinical practice is the Mini-Mental State Examination (MMSE) [23], an 11-item instrument (scored 0 to 30) that assesses a range of cognitive abilities. Marked impairment on the MMSE may reflect either delirium or dementia, which would lead to a more thorough history of the impairment, including its onset, course (ie, fluctuating versus continuous), features (eg, attention and level of consciousness), and possible precipitating factors. If delirium is suspected, the Confusion Assessment Method [24], a 9-item observer-rated tool, has been shown to be a highly sensitive and specific diagnostic method. Both depression and anxiety are encountered frequently in the palliative care population. Although a detailed evaluation for depression and anxiety may be performed best by a mental health professional, research has found that easily performed single-item screens have a high diagnostic yield and can be incorporated readily into the palliative assessment. For example, Chochinov and colleagues [25] have reported that the single question ‘‘Are you depressed?’’ outperformed longer assessment tools in identifying depression in 197 cancer patients, and Jacobsen and colleagues [26] found that a single-item ‘‘distress thermometer’’ compared favorably with longer assessment tools in identifying anxiety and depression in 380 ambulatory oncology patients. The physician should inquire about the patient’s emotional response to illness, including coping strategies and commonly expressed fears about burden, dependency, indignity, and abandonment. A sympathetic inquiry about such fears can help the physician direct appropriate resources to them (eg, social work or psychologist support) and can be therapeutic in its own right. Examples of questions to assess emotional symptoms and coping are provided in Box 3. Patients facing advanced illness, regardless of their religious background, typically experience a broad range of spiritual and existential concerns. Studies have shown that patients’ spirituality is particularly important in the setting of advanced illness [27] and that patients value physicians who are willing to explore the spiritual aspects of their lives [28]. Patients’ religious or spiritual beliefs also may influence their preferences for life-sustaining treatments in important ways, making it incumbent on physicians to understand those beliefs as part of treatment decision making and advance care planning. Several frameworks have been offered to guide the physician in exploring patients’ religious and spiritual perspectives [29]. A popular spiritual assessment tool proposed by Puchalski and Romer [30] uses the acronym FICA, which includes assessment for the presence of faith (F) or belief or for sources of meaning in the patient’s life; the importance (I) that the patient’s spiritual beliefs (or sources of meaning) play in dealing with the illness; the patient’s spiritual community (C) or other community that serves as a source of support during

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Box 3: Examples of inquiry into psychological and spiritual functioning Questions to solicit personal history Where do you originally come from? Who is your family? Who are your close friends? What type of work do (did) you do? What do you enjoy doing with your free time? Have you done anything in your life that you’ve regretted? What experiences have you had with serious illness, in yourself or those close to you? How has this illness affected your life? Questions to assess patient emotional concerns What is the hardest part of this illness for you? Where do you turn for comfort when things are difficult? What things about your illness worry you? What do you see as your biggest challenge now? Do you often feel depressed? Do you often feel anxious? Questions to assess spiritual orientation Do you consider yourself a religious person? Do you consider yourself a spiritual person? What do you find most meaningful in your life now? Do you feel peaceful, or are you having difficulty finding peace? What are you hoping for in the future? How might I be of assistance to you in supporting your spiritual beliefs?

difficult times; and how the patient would like these issues to be addressed (A) as part of his or her health care. Once spiritual concerns have been identified, or if the physician feels uncomfortable inquiring about spiritual concerns, involvement of a hospital chaplain as a spiritual expert is indicated. In addition to the general spiritual assessment, the physician may wish to explore with the patient a set of ‘‘developmental tasks’’ near the end of life, as proposed by Byock (Table 2) [21]. These tasks should be seen as a positive opportunity for growth near the end of life. The physician can present these tasks as a means of permitting the patient some element of hope, control, and goal orientation in situations in which the patient (or physician) fears that ‘‘nothing more can be done.’’

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Table 2 Developmental landmarks and taskwork for the end of life [20,31] Landmarks

Taskwork

Sense of completion with worldly affairs

Transfer of fiscal, legal and formal social responsibilities Closure of multiple social relationships (employment, commerce, organizational, congregational) Components include: expressions of regret, expressions of forgiveness, acceptance of gratitude and appreciation Leave taking; the saying of goodbye Life review The telling of ‘‘one’s stories’’ Transmission of knowledge and wisdom Self-acknowledgment Self-forgiveness Acceptance of worthiness Reconciliation, fullness of communication and closure in each of one’s important relationships. Component tasks include: expressions of regret, expressions of forgiveness and acceptance, expressions of gratitude and appreciation, acceptance of gratitude and appreciation, expressions of affection Leave-taking; the saying of goodbye Acknowledgment of the totality of personal loss represented by one’s dying and experience of personal pain of existential loss Expression of the depth of personal tragedy that dying represents Decathexis (emotional withdrawal) from worldly affairs and cathexis (emotional connection) with an enduring construct Acceptance of dependency Developing self-awareness in the present

Sense of completion in relationships with community

Sense of meaning about ones’ individual life Experienced love of self Experienced love of others Sense of completion in relationships with family and friends

Acceptance of the finality of life-of one’s existence as an individual

Sense of a new self (personhood) beyond personal loss Sense of meaning about life in general

Surrender to the transcendent, to the unknown - ‘‘letting go’’

Achieving a sense a awe Recognition of a transcendent realm Developing/achieving a sense of comfort with chaos In pursuit of this landmark, the doer and ‘‘taskwork’’ are one. Here, little remains of the ego except the volition to surrender.

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GOALS OF CARE Assisting in clarifying goals of care and identifying a treatment plan that best adheres to those goals are among the most frequent requests of the palliative care specialist. Goal setting is fundamental to all medical specialties, but in patients who have advanced illness, determining goals of care is both particularly important and difficult. First, in advanced illness, the ability of medical interventions to cure or even effectively manage the patient’s disease is often limited. As a result, assumptions cannot be made that a patient prefers maximal attempts to treat disease, particularly as the burdens of medical interventions required to serve that goal increase. Second, patients vary widely in the way they weigh the tradeoffs inherent in choosing among goals. One patient may value the chance to live longer over any other consideration, whereas another patient may feel that other factors such as family burden, independence, or physical comfort may carry more weight than the desire to live as long as possible. These deeply held values depend on many personal and cultural factors but ultimately present challenges as doctors and patients negotiate treatment decisions. Finally, discussing goals of care is emotionally difficult for both the patient and physician because it often involves giving bad news, addressing issues of hope, frustration, and despair, and the physician confronting the physician’s professional limitations. Nevertheless, wellconducted and documented discussions enhance the patient-physician relationship, reassure patients that care will be matched optimally to their goals, and facilitate medical care by informing providers about patients’ priorities. Before initiating a goals-of-care discussion, the physician must first identify the appropriate individuals to act as decision makers. A patient who has decisional capacity (ie, can understand the situation, including the benefits and burdens of alternative approaches to care, can manipulate information to arrive at a preference that is rationally grounded according to his or her values, and can communicate that preference) should typically be the primary decision maker. However, some patients prefer that goals be set as part of a family decision making process or even that family members take charge of decision making [31,32]. When a patient lacks the capacity to make decisions, the appropriate surrogate needs to be identified. Some patients have formally identified a surrogate by previously completing a durable power of attorney for health care document. If no surrogate has previously been designated, a surrogate can be selected either through stipulations set forth by state law, when such law exists (typically in the order of spouse, adult child, sibling, more distant relative), or informally, by identifying the most involved family member or loved one. Once appropriate decision makers have been identified, arriving at goals of care involves a series of steps that includes clarifying prognosis, identifying achievable and desired outcomes and tradeoffs among them, soliciting the value the patient places on those outcomes and tradeoffs, and deciding on a treatment plan that fits those values. A suggested framework for such a discussion is given in Table 3.

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Table 3 Goals of care discussion framework Domain

Sample intro question

Topics to discuss

Condition and prognosis

‘‘What have the doctors told you about what to expect in the future with regard to your illness?

1. How much the patient knows 2. How much he/she wants to know 3. Information about the condition 4. Addressing emotions

Achievable goals/ tradeoffs

‘‘In situations like this there are a number of approaches one can take, depending on what’s most important to a person. . .’’ Patient values ‘‘What things are you weighing in your mind as we discuss our treatment options? What things are important to you?’’ Recommended plan ‘‘Based on our discussion it of care sounds as if you want your care to focus on________.’’ Proxy decision maker ‘‘Whom would you want to represent your wishes in medical decisions if you were unable to speak for yourself?’’ Unacceptable health ‘‘Can you imagine any states situation of poor quality of life in which you wouldn’t want the doctors to help you live longer?’’ End of life priorities ‘‘If it became clear that you were close to the end of your life, what would be important to you at that time?’’

Different approaches to care based on focus – survival duration, comfort, being at home, and so on Attitudes towards maximizing survival, comfort, being at home, burden, etc. Patient concerns about recommendations Encourage discussion between patient and proxy about end of life preferences

Patient values (eg, towards cognitive/physical function or burden that influence treatment preferences) Views towards comfort versus survival duration when death is near; recommended limits on rx of little utility in dying patients (eg, CPR, intubation)

The first step in discussing goals of care requires that the physician understand the patient’s prognosis for survival as well as functioning, symptoms, and other outcomes, contingent on a given treatment approach. For instance, patients diagnosed with advanced or metastatic esophageal cancer who are functionally well enough to receive chemotherapy have a median survival of approximately 7 to 9 months [33,34], with 1-year survival depending on several measurable factors, including performance status, location of metastases, and serum alkaline phosphatase level [35]. Although the ability to predict a prognosis varies widely across providers and diseases [36,37], a command of published data on prognosis permits the physician insight into the patient’s possible futures based on identified goals of care. Because discussing prognosis often involves breaking difficult news to the patient, the framework for delivering bad news also applies [38] to the goals of care discussion.

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During the next steps in the discussion the physician reviews the range of treatment approaches that may reasonably be pursued, and elicit’s the patient values regarding the outcomes and tradeoffs associated with each approach to care. As discussed above, patients approaching the end of life value a variety of outcomes, including but not limited to survival duration, comfort, being at home, and limiting family burden. Patients also differ widely in the weight they place on these outcomes [39], making it essential to individualize goal setting and treatment decision making. Although the full result of a given set of treatment goals on the patient’s future may be difficult to predict at the outset, some goals of care are associated with a high likelihood of certain outcomes. For instance, a patient whose goals are to prolong survival at all costs is likely to spend his or her final days of life in an intensive care unit, whereas a focus on remaining comfortable at home may well involve foregoing treatment of a disease complication that might prolong a patient’s life for a period of time. Many tradeoffs may not be readily apparent to the patient or even to the physician. For instance, although whole-brain irradiation is considered the standard of care for multiple, symptomatic brain metastases, it generally requires a 2week treatment course involving daily trips to the hospital. In situations in which life expectancy is short or the patient is debilitated, the decision to pursue brain irradiation should entail frank discussions of which valued outcomes may be enhanced and which may be adversely affected by alternative approaches to care. After eliciting the patient’s values toward treatment outcomes, the physician can recommend a plan of care. Experts have argued that given the physician’s expertise in the technical aspects of care, including prognosis and treatment effectiveness, the physician should make treatment recommendations rather than simply providing options to the patient [40]. Recommending a care plan includes reaffirming the primary outcomes on which care will focus, along with how the tradeoffs inherent in choosing those outcomes will be managed. The physician should recommend which treatments should be provided and which should be withheld (often including cardiopulmonary resuscitation or mechanical ventilation) because they are unlikely to serve the overall care goals. The physician should offer opportunities for the patient to express concern or disagreement and educate the patient that he or she is free to alter the treatment plan as clinical circumstances change. The final step in the goals of care discussion entails advance care planning. The present author’s suggestions for advance care planning include a minimum of three elements: (1) the designation of a surrogate decision maker in case of future mental incapacity; (2) the identification of unacceptable health states; and (3) the identification of priorities in cases in which survival duration is expected to be short and life-prolonging medical treatment is required. The latter two elements are useful even when the patient has previously completed a living will because they help to clarify the vague general statements included in living will documents [41]. Examples of questions to introduce these discussion elements are listed in Table 2.

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SOCIAL SUPPORT AND CAREGIVER NEEDS In contrast to most disciplines of medicine, palliative care defines the unit of care to include both the patient and his or her caregivers. Patients facing advanced illness are typically part of a social network of family or other loved ones who provide physical care as well as emotional and spiritual support for the dying person [21]. Terminal decline is accompanied by increasing physical dependence; anticipating and planning for dependence can help mobilize the resources and supports for caregivers that can allow individuals to remain at home until death. Alternatively, unmet physical care needs can lead to physical safety hazards within the home and ultimately to the need for institutional care near the time of death. Screening for social supports can help the physician identify interpersonal issues that may affect treatment decision making, adherence to treatment, and clinical course. Moreover, it will enrich the patient-physician relationship by communicating to the patient the physician’s concern about the disease process and about the patient’s overall illness experience. Screening commonly entails identifying the patient’s living situation, including current and potential caregivers, family dynamics, including discord or stressors on family relationships, financial concerns, and current community supports (eg, church groups and support groups). More detailed assessment by the team social worker is almost always indicated. The social worker can educate patients and caregivers about available benefits and community resources, provide emotional counseling, and facilitate transitions into hospice and, if additional care is needed, from the home-based to an institution-based care setting. Caregivers are affected financially, emotionally, and physically, during a loved one’s illness. In a large study [42] of the seriously ill, one third of patients required active caregiving assistance from a family member. In 20% of cases, a family member had to quit work or make a major life change to accommodate the needs of the patient, and one third of families lost most or all of their life savings providing care for the ill patient. Caregivers of patients who have advanced illness have also been shown to be at high risk for emotional problems, including depression [43], and coping during the bereavement period affects long-term depressive symptoms and quality of life. An assessment of caregiver needs includes screening for financial difficulties, caregiving responsibilities in terms of time spent and perceived physical and emotional burden, emotional adjustment, including changes in the patient-caregiver relationship and roles, and sources of caregiver support. Involvement of the team social worker is usually indicated to assess caregiver needs further and to initiate appropriate support. ANTICIPATORY CONCERNS Patients’ concerns about the future represent a major source of stress, with regard to emotional and existential issues and with regard to practical concerns, including their preferred setting for their end-of-life care and their care after death. In a study of patients, families, and health care providers, Steinhauser

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and colleagues [39] found that dying at home was ranked among the least important overall of nine attributes of a good end-of-life experience, yet there was wide variability across respondents, with some patients feeling a strong preference to die at home and others having a strong desire to die outside of the home. Such variability highlights the importance of active inquiry into patients’ preferred location, if any, of their terminal care. In the same study, the authors found that other practical concerns in preparing for death, for example having funeral arrangements planned, weighed heavily on patients’ minds and should be discussed openly as part of the palliative evaluation. Finally, the physician should be prepared to discuss patient preferences for care of their body after death, including the preference for donation of organs or of the body for scientific purposes. This discussion helps to promote self-determination and facilitates patients’ sense of making a contribution even in death. MEDICATIONS Palliative assessment requires thorough attention to medications, including those prescribed to relieve symptoms, improve quality of life, or extend survival (if desired) and to those that should be discontinued because of toxicity or lack of benefit to the patient. Physical frailty, organ dysfunction, and cognitive decline accompanying advanced illness, often complicated by advanced age or other comorbidities, increase patients’ sensitivity to medication side effects [44]. Polypharmacy also increases with advanced illness complexity and the number of symptoms to be treated. This combination of sensitivity to medication side effects and risk of polypharmacy places the seriously ill patient at high risk for medication toxicity [45] and provides an opportunity to minimize that risk through judicious discontinuation of harmful or unnecessary medications, substitution of better tolerated alternatives, and prescription of lowest risk options as new medications are needed. As part of the medication review, the physician should inquire about symptoms that may indicate medication toxicity, including neuropsychiatric (fatigue and sedation, hallucinations, agitation, and confusion), gastrointestinal (nausea, constipation, diarrhea, and anorexia), and cardiovascular symptoms (orthostasis), recognizing that medication toxicity can often be difficult to distinguish from symptoms of the underlying disease. The physician should pay special attention to medications with anticholinergic (eg, tricyclics for neuropathic pain and certain antiemetics) and sedative (eg, opiates, muscle relaxants, tricyclics, anticonvulsants, and neuroleptics) properties, which risk exacerbating common symptoms, including confusion, dry mouth, constipation, and fatigue. Finally, the physician should seriously consider discontinuing medications being used for primary or secondary disease prevention, which offer little or no benefit over the course of the patient’s remaining life. The benefits of these medications, including statins for hyperlipidemia, antihypertensives for mild or moderate hypertension, and aspirin for cardioprotection, are measured over populations of patients with years of continuous use. Although such medications may carry symbolic meaning for the patient or family, continuing them

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until death carries added expense and risk of toxicity, often without accompanying medical benefit. PHYSICAL EXAMINATION A directed physical examination of the palliative care patient can provide both diagnostic and psychologic benefit. Diagnostically, the examination can help the physician identify the cause of specific physical symptoms. For example, abdominal pain in the patient who has advanced cancer may result from any number of causes, including tumor infiltration of the bowel or adjacent structures, adynamic ileus from opioids, opioid-induced constipation, urinary tract infection, or other causes that may readily be distinguishable through a careful physical examination. The physician should of course be judicious in limiting uncomfortable examination elements to the minimum required to achieve the examination’s overall palliative goals. In addition to its diagnostic value, the physical examination can offer psychologic benefit to the patient and family. At a time in the illness course when cure can no longer be offered, even as the physician makes recommendations to reduce the intensity of medical interventions, the physical examination’s ‘‘laying on of hands’’ offers a potent symbol of nonabandonment. LABORATORY EVALUATION Although a detailed discussion of laboratory and other testing for diagnostic and monitoring purposes is beyond the scope of this article, it should be noted that the decision to perform such testing should be determined largely by the goals of care developed with the patient and family. Patients with palliative goals often suffer from overly zealous testing at the hands of the medical care system. Such testing may be considered ‘‘standard of care,’’ it may provide reassurance to a physician who is ambivalent about the goals of care, or it may be performed simply out of habit. On the other hand, testing is appropriate and, in fact, necessary in situations in which it will help to achieve outcomes that are important to the dying patient and family. Because tests create additional burdens on the patient in terms of comfort, time, and cost, the physician should remain vigilant to how testing will influence patient management. Such influence depends on several factors, including sensitivity and specificity of the test as well as the pretest probability of findings that would lead to a change in clinical management. SUMMARY Patients who have advanced illness present unique challenges to the specialist physician. Gastroenterologic care of this group of patients has changed substantially over the past 2 decades, with diagnostic and therapeutic procedures often supplanting the more communication-based aspects of care. At the same time, given the range of patients’ palliative needs and the increasingly important role of the gastroenterologist in their overall care, the physician has a responsibility to develop basic competencies in palliative medical practice. Skill in palliative

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assessment can help the physician assure that care remains finely attuned to the goals, needs, and priorities of the patient and family. Acquiring and applying palliative care skills will, as a result, lead to both better outcomes for patients and families and a fully satisfying professional experience for the physician. References [1] Cassel EJ. The nature of suffering and the goals of medicine. N Engl J Med 1982;306(11): 639–45. [2] World Health Organization. Cancer pain relief and palliative care. Geneva (Switzerland): World Health Organization; 1990. [3] Singer PA, Martin DK, Kelner M. Quality end-of-life care: patients’ perspectives. JAMA 1999;281:163–8. [4] Steinhauser KE, Clipp EC, McNeilly M, et al. In search of a good death: observations of patients, families, and providers. Ann Intern Med 2000;132:825–32. [5] AGS Ethics Committee. The care of dying patients: a position statement from the American Geriatrics Society. J Am Geriatr Soc 1995;43(5):577–8. [6] Field MJ, Cassel CD, editors. Approaching death: improving care at the end of life. Washington (DC): National Academy Press; 1997. [7] Neuenschwander H, Bruera E. Asthenia. In: Oxford textbook of palliative care. 2nd edition. New York: Oxford University Press; 1998. p. 575. [8] Management of Cancer Pain Guideline Panel. Management of cancer pain: clinical practice guideline no. 9. AHCPR publication no. 94–0592. Rockville (MD): AHPCR; 1994. [9] Saunders C. Care of patients suffering from terminal illness at St. Joseph’s Hospice, Hackney, London. Nursing Mirror 1964;14:vii–x. [10] Marks RM, Sachar EJ. Undertreatment of medical inpatients with narcotic analgesics. Ann Intern Med 1973;78(2):173–81. [11] Cleeland CS, Gonin R, Baez L, et al. Pain and treatment of pain in minority patients with cancer. The Eastern Cooperative Oncology Group Minority Outpatient Pain Study. Ann Intern Med 1997;127:813–6. [12] de Wit R, van Dam F, Abu-Saad HH, et al. Empirical comparison of commonly used measures to evaluate pain treatment in cancer patients with chronic pain. J Clin Oncol 1999;17(4):1280. [13] Bruera E, Kuehn N, Miller MJ, et al. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 1991;7(2):6–9. [14] Chang VT, Hwang SS, Kasimis B, et al. Shorter symptom assessment instruments: the Condensed Memorial Symptom Assessment Scale (CMSAS). Cancer Invest 2004;22(4):526–36. [15] Hwang SS, Scott CB, Chang VT, et al. Prediction of survival for advanced cancer patients by recursive partitioning analysis: role of Karnofsky performance status, quality of life, and symptom distress. Cancer Invest 2004;22(5):678–87. [16] Katz S, Ford AB, Moskowitz RW, et al. Studies of illness in the aged: the index of ADL: a standardized measure of biological and psychosocial function. JAMA 1963;185:914–9. [17] Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969;9(3):179–86. [18] Verger E, Salamero M, Conill C. Can Karnofsky performance status be transformed to the Eastern Cooperative Oncology Group scoring scale and vice versa? Eur J Cancer 1992;28A(8–9):1328–30. [19] Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In: MacLeod CM, editor. Evaluation of chemotherapeutic agents. New York: Columbia University Press; 1949. p. 196. [20] Anderson F, Downing GM, Hill J, et al. Palliative performance scale (PPS): a new tool. J Palliat Care 1996;12(1):5–11. [21] Byock IR. The nature of suffering and the nature of opportunity at the end of life. Clin Geriatr Med 1996;12(2):237–52.

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[22] Bruera E, Miller L, McCallion J, et al. Cognitive failure in patients with terminal cancer: a prospective study. J Pain Symptom Manage 1992;7(4):192–5. [23] Folstein M, Folstein S, McHugh S. Mini-mental state: a practical method for grading the cognitive status of patients for the clinician. J Psychiatr Res 1975;12:189–98. [24] Inouye SK, van Dyck CH, Alessi CA, et al. Clarifying confusion: the confusion assessment method: a new method for detection of delirium. Ann Intern Med 1990;113(12):941–8. [25] Chochinov HM, Wilson KG, Enns M, et al. ‘‘Are you depressed?’’: screening for depression in the terminally ill. Am J Psychiatry 1997;154:674–6. [26] Jacobsen PB, Donovan KA, Trask PC, et al. Screening for psychologic distress in ambulatory cancer patients. Cancer 2005;103(7):1494–502. [27] Emanuel LL, Alpert HR, Baldwin DC, et al. What terminally ill patients care about: toward a validated construct of patients’ perspectives. J Palliat Med 2000;3(4):419–31. [28] Curtis JR, Wenrich MD, Carline JD, et al. Understanding physicians’ skills at providing endof-life care: perspectives of patients, families, and health care workers. J Gen Intern Med 2001;16:41–9. [29] Lo B, Ruston D, Kates LW, et al. Discussing religious and spiritual issues at the end of life: a practical guide for physicians. JAMA 2002;287:749–54. [30] Puchalski CM, Romer AL. Taking a spiritual history allows clinicians to understand patients more fully. J Palliat Med 2000;3:129–37. [31] High DM. All in the family: extended autonomy and expectations in surrogate health care decision-making. Gerontologist 1988;28(Suppl 3):S46–51. [32] Available at: http://www.dyingwell.com/landmarks.htm#dev. [33] Kroep JR, Pinedo HM, Giaccone G, et al. Phase II study of cisplatin preceding gemcitabine in patients with advanced oesophageal cancer. Ann Oncol 2004;15(2):230–5. [34] Conroy T, Etienne PL, Adenis A, et al. Vinorelbine and cisplatin in metastatic squamous cell carcinoma of the oesophagus: response, toxicity, quality of life and survival. Ann Oncol 2002;13(5):721–9. [35] Chau I, Norman AR, Cunningham D, et al. Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer: pooled analysis from three multicenter, randomized, controlled trials using individual patient data. J Clin Oncol 2004;22(12): 2395–403. [36] Lamont EB, Christakis NA. Physician factors in the timing of cancer patient referral to hospice palliative care. Cancer 2002;94(10):2733–7. [37] Lynn J, Harrell F Jr, Cohn F, et al. Prognoses of seriously ill hospitalized patients on the days before death: implications for patient care and public policy. New Horiz 1997;5(1): 56–61. [38] Baile WF, Buckman R, Lenzi R, et al. SPIKES: a six-step protocol for delivering bad news: application to the patient with cancer. Oncologist 2000;5(4):302–11. [39] Steinhauser KE, Christakis NA, Clipp EC, et al. In search of a good death: observations of patients, families, and providers. Ann Intern Med 2000;132(10):825–32. [40] Emanuel EJ, Emanuel LL. Four models of the doctor-patient relationship. JAMA 1992;267: 2221–6. [41] Brett AS. Limitations of listing specific medical interventions in advance directives. JAMA 1991;266:826. [42] The SUPPORT Principal Investigators. A controlled trial to improve care for seriously ill hospitalized patients: the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). JAMA 1995;274:1591–8. [43] Schulz R, Mendelsohn AB, Haley WE, et al. End-of-life care and the effects of bereavement on family caregivers of persons with dementia. N Engl J Med 2003;349(20):1936–42. [44] Balducci L, Yates J. General guidelines for the management of older patients with cancer. Oncology 2000;14(11A):221–7. [45] Field TS, Gurwitz JH, Avorn J, et al. Risk factors for adverse drug events among nursing home residents. Arch Intern Med 2001;161(13):1629–34.

Gastroenterol Clin N Am 35 (2006) 41–52

GASTROENTEROLOGY CLINICS OF NORTH AMERICA

Conveying Adverse News in End-of-Life Situations M. Bruce Dratler, MDa,b,*, Mary Katherine Burns, RNb, Heather L. Dratlerc a

Northwest Physicians Associates, 1012 Water Street, Meadville, PA 16335, USA West County Hospice of Crawford County, 448 Pine Street, Meadville, PA 16335, USA c Cornell University, College of Agriculture and Life Sciences, 274 Roberts Hall, Ithaca, NY 14853-4203, USA b

T

here is no easy way to convey adverse news to patients and their families in end-of-life situations. However, differences in attitudes and customs during end-of-life situations have been observed across cultures and religions. This article examines such differences in attitudes as they relate to the cultural and religious backgrounds of patients and their families. Once physicians grasp an understanding of cultural differences in end-of-life situations, they can strive to convey adverse news in the most sensitive and respectful way possible. The discussion also considers various approaches to the actual communication of adverse news and incorporates the authors’ personal experiences with different patients to illustrate a broad range of situations. If physicians can learn to convey adverse news to patients and their families in the most sensitive and honest way possible they can help to reduce the fear and uncertainty that is undoubtedly encountered in end-of-life situations.

UNDERSTANDING DIFFERENCES IN ATTITUDES ABOUT DEATH BASED ON CULTURE The population of the United States has come to include a large variety of ethnic groups. Although it is important to avoid stereotypes and generalizations, it is still possible to identify some basic values across these cultural dimensions. Such values have developed over the years as products of the histories, origins, opportunities, standards, and principles of various cultures. Although specific predictions cannot be made for particular patients and families, knowledge of general cultural values can help physicians choose appropriate approaches for communicating with patients and families about their situations.

*Corresponding author. E-mail address: [email protected] (M.B. Dratler). 0889-8553/06/$ – see front matter doi:10.1016/j.gtc.2005.12.001

ª 2006 Elsevier Inc. All rights reserved. gastro.theclinics.com

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AFRICAN AMERICAN VALUES According to the United States Census of 2000, African Americans account for 12.3% of the American population [1]. However, African Americans account for only 8% of hospice patients [2]. This percentage may derive from the idea that African Americans’ attitudes toward health care stem from their long history of struggle and discrimination in American society [3]. For example, the Tuskegee experiments conducted between 1932 and 1972 explicitly denied access to penicillin treatment for black males who had syphilis. The men were not notified of the existence of a treatment, nor were they informed that the government, in fact, was not administering any treatment at all [4]. It has been suggested that knowledge of this experiment, along with other discriminatory factors, has led African Americans to a general distrust of the health care system that is led by whites. Studies have shown that only 16% of elderly African Americans complete advance directives, compared with 40% of elderly whites [5]. It has been indicated that such directives and donot-resuscitate orders are perceived by African Americans as denying treatment to patients, which is also reminiscent of the Tuskegee experiments [6]. Less use of invasive procedures for heart and lung problems and less access to transplantation procedures have been reported for African Americans, perhaps supporting the idea that they actually cannot completely trust the health care system [7]. It has also been found that African Americans are more interested in prolonging life than easing pain, in comparison with whites [3]. This finding correlates with the general value that African Americans place on suffering as a spiritually meaningful experience [8]. African Americans are typically very religious and family oriented. In times of death, they commonly place great importance on the presence of their families and the expression of emotions [6]. Likewise, African Americans are more likely to value shared decision making between the patient and the family members, as opposed to pure patient autonomy in end-of-life situations [8]. Interestingly, the combination of distrust for the health care system and reluctance of patients to make decisions about their care on their own has led to a lack of communication between terminally ill African American patients and their physicians [3]. Unfortunately, this lack of communication between patient and physician results in the physician choosing the direction of treatment, without patient input. A pattern has been discovered among African Americans that identifies a preference for more aggressive treatments for terminal illnesses [7]. Without communicating such preferences to the physician, African Americans may be left with a treatment that does not fully satisfy them. Bridging the gap between African Americans and their physicians may involve greater physician understanding of the distrust, subsequent reluctance to communicate, and reliance on family members within the African American community. Understanding these factors within African American culture can help physicians to shape their approaches to conveying adverse news.

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ASIAN VALUES Historically, Asian cultures differ from Western cultures along the dimension of collectivism versus individualism [9]. This disparity may become extremely important in making health care decisions. A collectivist society places more emphasis on community and family interdependence, with less importance placed on the well being, advancement, and independence of the individual [9]. Western societies focus more on individual rights and personal gain. Thus, the American medical system generally supports autonomy in patient decision making, truth-telling about diagnoses, and letting the patient make decisions, unless they are declared medically incompetent to do so [3]. This attitude differs greatly from the Asian perspective, in which the family is affected just as much as the individual is by illnesses and therefore should have control over any medical decisions. Asian cultures treat their elders with the utmost respect and reverence [8]. Hence, they often believe that the terminally ill should be protected from the knowledge of their condition. Asian families want their elders to maintain hope and happiness at the end of their lives, so the patients are often excluded from decisions made about their treatment [6], which explains why Asians tend not to sign advance directives [3]. Researchers have found that Asians sign far fewer advance directives than whites do [8]. American doctors need to become aware of the value placed on patient welfare in Asian cultures to be able to better communicate with Asian families about end-of-life situations. Aside from protecting the terminally ill, Asian families also tend to prefer aggressive treatments for their loved ones [8]. They feel an obligation to their elders and thus may feel unfulfilled if every possible treatment is not exhausted. Likewise, elderly Asians have been reported to feel obligated to stay alive, to protect the welfare of the family unit [8]. These basic tendencies of Asian families in end-of-life situations stem from the Asian tradition of honoring elders. However, there are also other tendencies arising from other Asian beliefs that are not necessarily always consistent. In some Chinese cultures, a ‘‘good death’’ is considered one in which the dying patient is surrounded by family members and has a full stomach [6]. Some Chinese families consider it improper to talk about death at all, believing it will bring bad luck [3]. Likewise, in some Filipino cultures, words are considered so powerful that they believe talking about something will make it happen. Thus, they may refuse to discuss the patient’s condition or any medical options [8]. Regardless of these tendencies and attitudes, it has been found that many Asians have assimilated their customs with American culture throughout the generations. Japanese Americans, especially, have demonstrated a great level of heterogeneity in their attitudes toward death [3]. Thus, it is important not to overlook these individual differences among families. With the general knowledge of Asian culture and attitudes, a physician should also interact with the individual families to determine the best method for treatment and care.

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HISPANIC VALUES The Hispanic culture in America stems from many different Latin nations. Culture has developed from origins in Mexico, Puerto Rico, Cuba, Central America, and South America, to name a few [3]. Each culture, depending on its origins, has a different attitude toward end-of-life care. However, all Hispanic origins tend to share some basic similarities in attitudes. Generally, Hispanic families tend to be very tightly knit units [6,8]. Thus, Hispanics tend to believe that the family should be responsible for making health care decisions [10]. Furthermore, Hispanic families may choose not to inform the patient of his or her terminal diagnosis because of the belief that doing so may eliminate all hope and cause the patient unnecessary distress [11]. Hispanics also tend to disapprove of signing advance directives, powers of attorney, or living wills [11]. This may be because of the patient’s belief that assigning responsibility to one family member may cause a rift between that member and the rest of the family. The patient also may be afraid of offending other family members. Hence, the patient and the family usually choose to make collective family decisions [8]. There is a low rate of Hispanic attendance in hospice programs throughout North America. Some researchers believe this is the result of distrust in the health care system. In addition, language barriers and lack of knowledge about hospice may contribute to this trend [3]. Physicians who speak Spanish may be more effective in communicating with Hispanic families about hospice programs and other issues in end-of-life situations. Many Hispanics are very religious. They may believe in both good and evil spirits that influence the health of family members [3]. Faith may become extremely important during times of illness and death. Furthermore, Hispanics tend to believe death is a very natural part of life. They celebrate the anniversaries of the death of their loved ones every year [3]. It is important to be sensitive to these religious beliefs during treatment and conveying of information. As with all minorities, the degree to which Hispanics will assimilate with the characteristics mentioned above depends on how much they have adopted American culture into their original heritage [11]. It would be wise for physicians to ask Hispanic families questions about treatment preferences. It may also be beneficial for the physician to ask the patients whether they desire the family to handle their care or whether they, in fact, want autonomy.

UNDERSTANDING THE ROLE OF RELIGION IN END-OF-LIFE SITUATIONS The United States has certainly become a melting pot for different religious beliefs. The problem encountered, however, when examining differences in religions, is that there are many differences in attitudes and customs even within the same religion. Generally, however, the basic tenets of most religions involve the belief in some sort of afterlife, the attempt to atone for one’s transgressions, and the endeavor to obey and serve some higher being. In fact, one study

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has shown that patients with strong religious beliefs tend to have less fear and anxiety about their deaths, although, this finding has not been found universally [12]. Even so, this observed effect may be because of the fact that the belief in an afterlife provides people with a definitive answer to what happens after death. It has also been suggested that the fear of death may motivate stronger religious beliefs [12]. One hospice nurse in the authors’ department commented that many people enter the hospice program with weak beliefs and as they progress toward their deaths they strengthen their faiths. This development of beliefs helps patients to cope with the inevitability of their deaths. Furthermore, she suggested that religious leaders can sometimes offer patients better counseling for their situation than the physician or nurse. Many patients, especially of the Christian faith, believe they should confess their sins before death to ensure themselves a place in heaven [13]. The nurse pointed out that religious leaders are often more successful in eliciting fears, feelings, and confessions from patients than are nurses and physicians. In fact, her own father was a member of the hospice program before his death. She related how he had been born with one arm, and it was not until the months approaching his death that he confessed to his minister that he had always felt inadequate because of his disability. He admitted feeling regret that he could not fight alongside his brothers in World War II. After confessing these feelings to the minister, he was able to let his insecurities go and found himself more at peace at the time of his death. Similar to the Christian desire to confess sins before death, Judaism also believes in a form of confession. Judaism maintains that before death, one should ask God for forgiveness for the sins committed against Him and ask for forgiveness from one’s fellow man. Most Jews associate repentance with the high holy days. The 10-day period from the start of Rosh Hashanah to the end of Yom Kippur is known as the Ten Days of Repentance. However, even when accompanied by sincere repentance, one is forgiven only for offenses committed against God, not for sins against man, unless the injured party has been appeased [14]. Islam also encourages a form of meditation before death. Muslims tend to believe that struggling against death is to go against Allah’s will. They often choose to spend their final days praying and contemplating [13]. Thus, as patients of any religion approaches their death, their religious beliefs may play a strong role in the way they cope with adverse news. As noted above, however, not all members of each faith believe in the same specific aspects and traditions that are conveyed in the religion’s law. Physicians, nurses, and religious leaders must get to know the individual patients to determine the best course of action for that patient’s level of faith.

CONVEYING ADVERSE NEWS TO PATIENTS AND THEIR FAMILIES: STUDIES Although each physician undoubtedly will come to develop his or her own style for delivering adverse news, suggestions have been made as to the

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particular methods, resulting from a variety of research. These suggestions may prove useful because physicians generally have had little training in communication skills [15]. One study, by Lutfey and Maynard [16], introduces the idea of a perspective display series. This method involves the physician approaching the topic of the patient’s diagnosis and impending death in a stepby-step manner, thus enabling the physician to elicit the patient’s perspective and level of understanding. It allows the patient and physician to build on one another’s thoughts until the final topic is encountered. One example given in the study was of a physician attempting to relate adverse news to a patient who had cancer of the gall bladder. The physician approached the subject by asking the patient what his plans were on discharge from the hospital and then asking the patient if anyone had talked to him about the hospice program. The physician here attempted to broach the subject of death by introducing the idea of hospice as an alternative to consider in case the patient did not recover [16]. Posing a hypothetical situation (nonrecovery) allows the patient to analyze the situation and start to plan for it before actually discovering that the situation is real. This advance preparation can make the actual news much less shocking because the patient will be, to some degree, prepared already [16]. The study furthermore suggests personal contact between the physician and patient. For example, the physician in this particular instance told the patient that he was concerned for him while at the same time holding the patient’s hand. This nonverbal contact aids in conveying to the patient that something serious lies ahead [16]. Another study, by Parker and colleagues [17], has examined patients of various ages, genders, and levels of education who have different types and stages of cancer. This study found that the three most important dimensions of conveying adverse news from the patient’s perspective consist of the content of the message, support provided by the physician, and the facilitation and setting of the delivery. This study concluded that the most important aspect of delivery to patients is that their physician possesses an expertise in the subject matter and that they receive detailed information about their diagnosis and treatment options. The authors suggest this may be because knowledge about available treatments provides the patient with hope that something can be done. It is important to note, however, that although the content of the message was rated as most important, the other two elements were still considered very significant [17]. This study also noted demographic differences between patients, such as women and those with more formal education place more emphasis on receiving detailed information, and women place a greater emphasis on emotional support than males do. The study suggests that physicians ask questions to discern the patients’ attitudes about each of the three dimensions to determine the best course of action [17]. Ptacek and Ptacek [18] conducted a study on conveying adverse news in end-of-life situations that correlated well with the study by Parker and colleagues [17]. Ptacek and Ptacek note that three important aspects of conveying news involve what is said, how it is said, and where it is said. They suggest that

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news be delivered in a comfortable setting without interruptions. They recommend that physicians turn off their beepers, sit close to the patient, and empathize with the patient’s emotions. They also suggest letting the patient know that bad news lies ahead, to prepare the patient [18]. This differs slightly from the Lutfey and Maynard study [16], which suggests physicians use nonverbal cues to relate that bad news is imminent. Ptacek and Ptacek recommend using verbal cues instead [18]. Examples of such verbal indicators of bad news include, ‘‘I’m sorry to have to tell you this. . .’’ or ‘‘Unfortunately, I have some bad news. . .’’ [19]. Ptacek and Ptacek furthermore explain that bad news is usually delivered poorly when a physician rushes through the information or struggles to find the right words. This poor delivery can have an upsetting impact on the patient [18]. Another method for delivering adverse news has been developed at the University of Texas. This method, entitled SPIKES, lists a protocol for physicians to deliver bad news to patients [19]. The ‘‘S’’ stands for ‘‘setting up the interview.’’ This portion of the protocol recommends a mental rehearsal for physicians before delivering the news. It suggests privacy, sitting down, involving significant others of the patient’s choice, connecting with the patient by eye or bodily contact, and removing interruptions [19]. A few of these aspects are those mentioned in the study by Ptacek and Ptacek, thus supporting the evidence further. The ‘‘P’’ in SPIKES stands for ‘‘assessing the patient’s perception.’’ This portion of the protocol encourages the physician to use open-ended question to assess how much the patient knows and understands about his or her condition before breaking the news. This allows the physician to clarify any misunderstandings and tailor the information specifically to the patient’s level of knowledge [19]. The ‘‘I’’ in SPIKES stands for ‘‘obtaining the patient’s invitation.’’ This step involves asking the patient at the time of testing how they would like the results to be explained [19]. Knowing ahead of time just how much information the patient wants divulged can help physicians to deliver news in a way that is sensitive to individual patient’s needs. The ‘‘K’’ in SPIKES stands for ‘‘giving knowledge and information to the patient.’’ The authors suggest warning the patient that bad news is coming, as is mentioned in both Lutfey and Maynard’s and Ptacek and Ptacek’s studies. The authors of SPIKES furthermore suggest using nontechnical words and vocabulary that is consistent with the patient’s level of understanding. They warn against delivering all of the information at once and suggest, instead, that it be delivered in portions and checking periodically whether the patient understands everything he or she is being told [19]. The fifth step in SPIKES, ‘‘E,’’ stands for ‘‘addressing the patient’s emotions with empathetic responses.’’ The authors identify four steps for creating an empathetic, supportive response to patients. The first step involves observing any emotion the patient may exhibit, such as crying, a look of sadness, silence, or shock [19]. Then the physician is asked to identify the emotion by naming it to himself or herself and to use open-ended questions to find out exactly what the

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patient is feeling. The physician must then identify the reason for the emotion, which is usually the bad news. Finally, the physician should connect the emotion with the reason and make a statement showing the patient that he or she is also concerned and understands the patient’s feelings [19]. The final step in SPIKES, ‘‘S,’’ stands for ‘‘strategy and summary.’’ The authors suggest that having a plan for the future reduces the patient’s anxiety and uncertainty surrounding impending death. They warn that physicians should first ask the patient if he or she is ready to discuss such options at that time. Sometimes, patients may wish to have some time to sort out emotions before discussing treatment options [19]. Note that three of the steps in SPIKES, S, K, and E, correlate directly with the three dimensions identified in the study by Parker and colleagues [17]. The S dimension corresponds with facilitation, the K with content, and the E with support. This lends further evidence to the effectiveness of these techniques. Another study, conducted by Wenrich and colleagues [20], recommends that the most important aspect of communication for physicians involves being honest and candid with patients. Information should be delivered in an organized manner, in language that the patient can understand; note that the use of nontechnical language has been suggested in previously mentioned studies, as well. Wenrich and colleagues maintain furthermore that physicians should listen with interest to the concerns and questions of the patient and the family by asking open-ended questions. These questions demonstrate concern for the patient [20]. Patients and their families should be given the opportunity to ask questions in a nonthreatening and unhurried environment, as illustrated also in both the SPIKES method and the Ptacek and Ptacek study [20]. Most importantly, physicians should always maintain an element of hope in their message, even if that hope involves only maximizing the quality of remaining life through the use of a hospice program [20]. The study by Wenrich and colleagues also mentions that the goal of delivering adverse news is to balance honesty with sensitivity so that it is not too blunt or too vague. Finally, it acknowledges that every patient is different and physicians must determine from previous conversations with patients how much information they will want to hear, how quickly, and when [20]. Dias and colleagues [21] used an interview with a woman who had been living with low-grade cancer for many years to discern different characteristics physicians should possess when delivering adverse news. The authors suggest reflection, which means repeating important words the patient uses to give the patient the opportunity to elaborate or ask further questions. They furthermore recommend clarification, to make sure the patient correctly understands the information being relayed to them. They advocate summarizing the information to ensure full comprehension and empathizing with the patient to lend emotional support [21]. Even though these methods and suggestions differ slightly, from one to the next, each study offers information that basically correlates to help physicians develop their own unique methods for conveying adverse news. Another study

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[22] has indicated an approach to teaching physicians these communication skills involving. The study involved pediatric intensive care fellows in a 1-day workshop that enabled them to practice conveying adverse news to mock parents of ill children. The results of the study showed an improvement in the fellows’ performance in conveying such news by the end of the workshop [22]. This approach is just one of the ways in which physicians can work to better deliver bad news to their patients.

CONVEYING ADVERSE NEWS TO PATIENTS AND THEIR FAMILIES: OUR OWN EXPERIENCE Through the personal experiences of the present authors, methods have been developed for conveying adverse news to patients enrolled in the authors’ hospice program. The cornerstone of relaying adverse news is to make sure the patient knows there is always something that can be done and that they are not alone. The goal is to strive to meet patients’ spiritual, emotional, and physical needs. There is always hope. A nurse who helped in the formation of the authors’ local hospice related that this cornerstone belief came about after a patient was referred from a physician from another city. The patient was a woman in her 40s who had terminal colon cancer. Her physician had told her there was nothing he or anyone else could do to help her. He even told her he could not increase her dosage of morphine to help the pain because her tolerance would need to be spared for later when her pain became unbearable. Her condition was deteriorating and, because of her extreme pain, she was unable to care for her children at home. When she was referred, she was assured that there is always something that can be done. She joined the authors’ hospice program, and her pain was able to be controlled. The next weekend, she went with her children to the mall located 30 minutes away. The woman survived for another 9 months. This experience taught that there is always hope to improve a patient’s quality of life, even if there is no cure. The end of her life was made comfortable enough for her to enjoy it with her family. There is never a reason to give up hope, even in the face of adverse news. It is also important to consider options other than hospice. Some patients, when faced with adverse news, are not ready to accept strictly palliative care. One patient who had a diagnosis of metastatic pancreatic carcinoma seemed to the senior author (M.B.D.) to be a perfect candidate for the hospice program, but after speaking with her and her family, hospice was not the appropriate path for her to take at the time. From talking with patients and their families, physicians can get a feel for their attitudes and wishes about their conditions. It was apparent that this person wanted to seek all available treatment options. When various options, including chemotherapy, were offered, she was relieved and said, ‘‘I was afraid you were going to say there was nothing more you could do.’’ This statement illustrates that physicians need the ability to extract patients’ and families’ attitudes and wishes about their treatments and that

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providing a patient with all available options is always better than saying there is nothing that can be done. Another method used at the authors’ hospice is to begin to prepare patients for adverse news and situations with the advance directive entitled ‘‘Five Wishes’’ [23]. The Five Wishes method covers two medical aspects of patient care as well as three emotional and spiritual aspects [23]. This advance directive has been found to be an excellent tool for introducing the topic of death into the conversation with patients and their families. In addition to broaching subjects of health care, such as appointing a health care agent, the type of health care the patient desires, and other life support issues, the Five Wishes also aids the staff in meeting the emotional needs of patients. It discusses how comfortable the patient wants to be, how the patient wants to be treated, and what the patient wants loved ones to know about him or her [23]. The emotional aspects of this advanced directive have made it a truly useful tool to gracefully introduce the difficult subject of death. Another facet of conveying adverse news involves younger family members. Sometimes families include young children who may not fully understand the concept of death. Many times, these children are overlooked as the patient and older family members deal with their own decisions and emotions. The present authors’ hospice nurses have realized the importance of children’s understanding. When there are younger children involved, the nurses use children’s books that illustrate the concepts of illness and death. These books help the children to comprehend what is happening [24–28]. Through continued use of these children’s books and time spent talking to the children about their questions and fears, the nurses have been able to successfully convey adverse news to young children in the healthiest, least frightening, and most complete way possible. The children benefit greatly from understanding what is going on. Leaving them uninformed about the situation will only lead to confusion and mixed emotions. This approach also helps the adult family members and the patients to know that they can talk openly with the children and even improve communication within their own families. Together, they can face the fears, stresses, and challenges that lie ahead and can find each other to be a warm source of support. SUMMARY It truly is an art to be able to delve into the minds and attitudes of individual patients to find a sensitive yet honest way to deliver adverse news. By taking into account some basic cultural and religious differences and observing individual differences in attitudes between different patients and families, the use of studied techniques for providing adverse news can be tailored to fit each patient’s specific needs. Conveying adverse news will never be simple. End-of-life situations will never be easy. Telling someone something that they do not want to hear will always be stressful. Optimistically, this information and perhaps training programs like the one used with the pediatric intensive care fellows

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can help to reduce the stress and anxiety, for the patient, the family, and the physician, when dealing with the uncomfortable possibility of death. Acknowledgments The authors thank the staff of West County Hospice of Crawford County, the nurses, social workers, aids, and ministers, without whom this report would not have been possible. References [1] US Census Bureau. US Census, 2000. Washington (DC): 2001. [2] National Hospice and Palliative Care Organization. Facts and figures on hospice care in America; 2001. [3] Braun K, Pietsch J, Blanchette P, editors. Cultural issues in end-of-life decision making. Thousand Oaks (CA): Sage Publications Inc; 2000. p. 71–125. [4] Caplan AL. Twenty years after: the legacy of the Tuskegee syphilis study. In: Teays W, Purdy LM, editors. Bioethics, justice and health care. Belmont (CA): Wadsworth-Thomson Learning; 2001. p. 231–5. [5] Hopp FP, Duffy SA. Racial variations in end-of-life care. J Am Geriatr Soc 2000;48:658–63. [6] Ersek M, editor. Core curriculum for the hospice and palliative nursing assistant. Dubuque (IA): Kendall/Hunt; 2003. p. 71–98. [7] Kagawa-Singer M, Blackhall LJ. Negotiating cross-cultural issues at the end-of-life. JAMA 2001;286(23):2993–3001. [8] Searight RH, Gafford J. Cultural diversity at the end of life: issues and guidelines for family physicians. Am Fam Physician 2005;71(3):515–23. [9] Green EGT, Deschamps JC, Paez D. Variation of individualism and collectivism within and between 20 countries: a typological analysis. Journal of Cross Cultural Psychology 2005;36(3):321–39. [10] Blackhall LJ, Murphy ST, Frank G, et al. Ethnicity and attitudes toward patient autonomy. JAMA 1995;274(10):820–5. [11] Berger JT. Cultural discrimination in mechanisms for health decisions: a view from New York. J Clin Ethics 1998;9(2):127–31. [12] Kahoe RD, Dunn RF. The fear of death and religious attitudes and behavior. J Sci Study Relig 1975;14(4):379–82. [13] Doyle D, Hanks GWC, MacDonald N, editors. Oxford textbook of palliative medicine. New York: Oxford University Press; 2001. p. 777–85. [14] Telushkin J. Jewish literacy: the most important things to know about the Jewish religion, its people and its history. New York: William Morrow and Co; 1991. [15] Back AL, Arnold RM, Baile WF, et al. Approaching difficult communication tasks in oncology. CA Cancer J Clin 2005;55:164–77. [16] Lutfey K, Maynard DW. Bad news in oncology: how physician and patient talk about death and dying without using those words. Social Psychology Quarterly 1998;61(4):321–41. [17] Parker PA, Baile WF, de Moor C, et al. Breaking bad news about cancer: patients’ preferences for communication. J Clin Oncol 2001;19(7):2049–56. [18] Ptacek JT, Ptacek JJ. Patients’ perceptions of receiving bad news about cancer. J Clin Oncol 2001;19(21):4160–4. [19] Baile WF, Buckman R, Lenzi R, et al. SPIKES: a six-step protocol for delivering bad news: application to the patient with cancer. Oncologist 2000;5:302–11. [20] Wenrich MD, Curtis JR, Shannon SE, et al. Communicating with dying patients within the spectrum of medical care from terminal diagnosis to death. Arch Intern Med 2001;161: 868–74. [21] Dias L, Chabner BA, Lynch TJ, et al. Breaking bad news: a patient’s perspective. Oncologist 2003;8:587–96.

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[22] Vaidya VU, Greenberg LW, Patel KM, et al. Teaching physicians how to break bad news. Arch Pediatr Adolesc Med 1999;153:419–22. [23] ‘‘Five wishes’’: Aging with Dignity. Tallahassee (FL); 2001. [24] Boulden J, Boulden J. Someone special is very sick. Weaverville (CA): Boulden Publishing; 1995. [25] Boulden J, Boulden J. Saying goodbye. Santa Rosa (CA): Boulden Publishing; 1992. [26] Channing L. Sad hug, mad hug, happy hug, a children’s story about death. South Deerfield (MA): Channing L Bete Co, Inc; 1994. [27] Klicker RL, Ligammari JJ. Kolie and the funeral. Madison (AL): Guideline Publications; 1988. [28] Doka KJ, editor. Living with grief, children, adolescents, and loss. Washington (DC): Hospice Foundation of America; 2000.

Gastroenterol Clin N Am 35 (2006) 53–64

GASTROENTEROLOGY CLINICS OF NORTH AMERICA

Assessment of Quality of Life Outcomes in the Treatment of Advanced Colorectal Malignancies Imran Hassan, MDa, Robert C. Cima, MDa,*, Jeff A. Sloan, PhDb a

Division of Colorectal Surgery, Mayo Clinic, Rochester, MN 55905, USA Division of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA

b

T

reatment interventions in patients who have cancer are directed at either curing disease, prolonging life, or controlling symptoms. As with every intervention, however, there are certain associated risks and potential side effects that can adversely affect the patient and his or her quality of life (QOL). When cure is the intent and extending life is the main objective, most patients who have potentially curable malignancies will accept a temporary and even significant decrease in QOL caused by treatment side effects for a potential increase in survival [1]. In situations in which the disease is metastatic, recurrent or locally advanced to the extent that it is considered ‘‘incurable,’’ survival is not an issue. Patients are faced with a completely different dilemma in which there is no hope for cure, and disease-related symptoms or their treatment limit physical and social activities. The realization of incurability can also have a significant psychologic and mental impact [1,2]. In this situation, preserving the quality of the patient’s remaining life is the fundamental objective. As stated by the World Health Organization (WHO), ‘‘Control of pain, of other symptoms, and of psychological, social, and spiritual problems is paramount. The goal of palliative care is the achievement of the best possible QOL for patients and their families’’ [3]. In the setting of palliative treatment for advanced malignancies, the primary goal is to temporarily control the incurable disease and alleviate the distressing symptoms that interfere with activities of daily living and other aspects of functioning, whereas producing minimal toxicity, thus maintaining or improving patient QOL [4]. Therefore, it follows that, in palliative care, preserving QOL in patients who have advanced malignancy is the primary outcome that should be used to determine which interventions are necessary and relatively successful. As a result, the concept of QOL and the issues regarding its valid assessment are central to the development, delivery, and evaluation

*Corresponding author. E-mail address: [email protected] (R.C. Cima). 0889-8553/06/$ – see front matter doi:10.1016/j.gtc.2005.12.010

ª 2006 Elsevier Inc. All rights reserved. gastro.theclinics.com

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of palliative treatment strategies in patients who have advanced malignancies [5]. DEFINITION OF QUALITY OF LIFE IN THE PALLIATIVE CARE SETTING QOL is a multidimensional construct that is influenced by several factors [4]. The QOL dimensions relevant to palliative care, as suggested by the Institute of Medicine, include the patient’s physical, psychosocial, and spiritual well being and functioning, the patient’s perception of care, and the family’s well being and perceptions [5]. Cella [6] defines QOL as ‘‘the extent to which one’s usual or expected physical, emotional, social, and spiritual well being are effected by a medical condition or its treatment.’’ As such, QOL is considered a strictly subjective perception that is best assessed by the patient. Several studies have shown significant disparities between QOL assessments made by health care providers and those made by patients, in which professional health care providers usually underestimate the actual decrease in patient QOL [7]. This subjective evaluation does not imply that QOL assessment is a ‘‘soft’’ outcome [8]. In fact, the methodological rigor involved in QOL assessment is just as rigorous, if not more so, as it is for objective outcomes such as survival and tumor response [1]. QOL also has been defined as the difference between the patient’s expectations and his or her actual experience. This difference has been supported by studies that have shown that among patients who pragmatically expected adverse effects of their disease or its treatment experienced less suffering when the adverse effects actually occurred. In the palliative setting, this implies that patient QOL can be improved not only by strategies that can change the symptom profile of the disease but also by strategies that can adjust the expectations of the patients to a more pragmatic level. ASSESSMENT OF QUALITY OF LIFE IN PALLIATIVE CARE The good news is that, despite some unique methodological challenges, the assessment of QOL has recently progressed substantially and has had numerous demonstrated successes in the application to cancer generally and colorectal cancer particularly [9–12]. Presently, many guidelines exist for assessing QOL that point clinical oncology researchers to appropriate design and assessments [13–16]. The scientific method applies as equally to QOL assessment as it does to other clinical outcomes, such as tumor response and survival. Several authors have pointed out that the challenges in assessing QOL endpoints are no more difficult, costly, or fraught with measurement error than any other clinical outcome except for survival. The assessment of QOL in palliative care brings additional challenges, albeit surmountable ones [10–12]. Most important is the recognition that patient burden must be considered paramount in such things as the number of questions involved and the timing of the assessment [17]. Sloan and colleagues [17] have demonstrated in repeated applications and settings that the necessary

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information for treatment modification or comparison often can be obtained by the use of simple, brief QOL assessments [17,18]. The key question to be asked in such situations is ‘‘what is needed to know’’ versus ‘‘what would be nice to know.’’ A key component of a QOL assessment is the a priori definition of what will be considered a clinically meaningful benefit to the patient [19]. Much has been written recently on this subject, with considerable advancement made in the available methodology [19–21]. A summary of techniques is available in Guyatt and colleagues’ [22] study, and the evolution of the one-half standard deviation (or 10 points on a 100-point scale) [23] as a reasonable estimate of a meaningful difference makes it now practical and achievable to readily incorporate QOL assessments into virtually any clinical oncology trial. The key to success, as with any other clinical outcome, is to define a meaningful research hypothesis to guide the study design and QOL assessment. As to the statistical methodology for QOL assessment generally and in oncology, although there are specific statistical challenges, such as multiple endpoints and missing data, none requires new statistical methodology [24]. The creation of summary statistics, missing data techniques, and handling of multiple endpoints have all been discussed in detail elsewhere, with satisfying techniques applied successfully [25–27]. POPULAR QUALITY OF LIFE ASSESSMENTS It is estimated that there are now more than 10,000 different QOL assessments available [28]. Hence, the need for designing new QOL assessments or for clinicians to ‘‘make one up’’ for a given study has long since past. The optimal approach today is to define the constructs or domains of QOL that are likely to be affected by a particular disease or treatment and then match the assessment from the pool of 10,000 to the required endpoints. For example, in colorectal cancer, it is typically essential to assess some measure of the patient’s perception of bowel function beyond the number and consistency of stools. There are specific measures, such as the Functional Assessment of Cancer Therapy (FACT)-C [29] for colorectal cancer generally and the FACT-D [30] for diarrhea, the Mayo Bowel Function Questionnaire [31], and the European Organization for Research and Treatment of Cancer (EORTC) colorectal cancer module [32]. All of these measures have been applied successfully in numerous clinical trials. In palliative care, one is often concerned about domains such as fatigue, anxiety, and spiritual well being. There are popular measures for fatigue (eg, Brief Fatigue Inventory [33] and Piper Fatigue Scale [34]). There are more than 100 different measures for anxiety, including the Hospital Anxiety and Depression Scale (HADS) [35], the Profile of Mood States [36], and the simple single-item assessment of anxiety [17]. A review of the various spiritual well being assessments appropriate for cancer patients has been completed recently [37]. One cautionary note is indicated regarding the use of the ubiquitous measures derived from the Medical Outcomes Study, such as the short form (SF)-36 and SF-12 [38,39]. Although these tools have been applied in

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many cancer-related situations, they have generally been more successful in studies of healthy individuals to detect QOL deficits. In cancer patients, especially those with advanced disease, there are many questions in the SF assessments that are insensitive because of potential irrelevance. For example, there are questions relating to climbing stairs and carrying groceries, which are not likely to be achievable activities of daily living for many cancer patients who have advanced disease. ADVANCED COLON AND RECTAL CANCER Colorectal carcinoma is the second leading cause of cancer-related deaths in the United States, with 130,000 new cases and 57,000 deaths occurring each year. Approximately 20% of the patients who have colorectal cancer present with metastatic disease. Although a small proportion of patients will have potentially resectable hepatic metastases, the majority of patients will have unresectable metastatic disease along with a primary tumor that can be symptomatic or asymptomatic and have a poor prognosis [40,41]. Among the patients who present with localized disease and undergo curative treatment, over half will eventually succumb to metastatic disease [42]. Although the rate of progression of metastatic colorectal cancer is variable, patients who do not undergo any treatment have a median survival of 6 to 9 months from the time of diagnosis, during which they can develop various physical and psychologic symptoms from their disease that can affect and diminish their QOL. PALLIATIVE INTERVENTIONS IN PATIENTS WHO HAVE ADVANCED COLORECTAL CANCER Palliative interventions in patients who have advanced colorectal cancer are directed at disease-related symptoms that can be caused by the primary tumor or the metastatic disease and can be divided into two main groups: 1. Urgent complications, such as abdominal or pelvic pain, obstruction, and perforation from the primary or recurrent disease 2. Chronic constitutional symptoms, such as anemia, fatigue, and weight loss caused by systemic disease burden

Palliative interventions in these patients can therefore be divided into two categories, therapies that treat the systemic disease, such as palliative chemotherapy, and therapies that target the primary or recurrent tumor, such as surgery, endoscopic interventions, and radiotherapy. Determining the most effective palliative strategy in these patients is a difficult and complex task. Although many patients who have advanced colorectal cancer eventually die of disease, the purpose of palliative treatment is to provide relief of both local and systemic symptoms that result from the disease process and to improve the quality of the patient’s remaining life. In this scenario, the side effects or the adverse consequences of any therapy or intervention versus no therapy or intervention at all must be balanced against the reality that the patient will eventually succumb to his or her underlying disease.

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RELEVANCE OF MEASURING QUALITY OF LIFE OUTCOMES IN RELATION TO THERAPY OF ADVANCED COLORECTAL CANCER Patients with advanced colorectal cancer are often severely debilitated because of their underlying disease, and as a result, their tolerance to adverse side effects and complications of therapy are diminished. A large number of these patients are elderly, in their seventh and eighth decades of life, and can have significant comorbidities. However, significant recent advances in the fields of medical and surgical oncology have resulted in the availability of several treatment options for these patients. For instance, chemotherapeutic agents such as oxaliplatin and irinotecans, antiangiogenic agents such as bevacizumab, and oral fluorouracil agents have become available in the management of these patients. Similarly, whereas surgery was once the only palliative option available to deal with the primary disease, the advent of advanced endoscopic techniques has broadened the armamentarium of physicians who take care of these patients. In situations in which different interventions have a similar impact on survival, the outcome to be measured in determining the optimal treatment strategy is patient QOL. However, some of these therapies have been shown to be superior to conventional therapies in terms of their affect on oncologic outcomes. This has given rise to the issue as to which is the best therapy for these patients and what kind of outcomes should be used as a benchmark to determine the benefit or effectiveness of one therapy over the other. In these situations, along with conventional oncologic outcomes, it is essential to assess whether this gain in ‘‘quantity’’ of life is of acceptable ‘‘quality.’’ The following sections discuss the various clinical scenarios that occur commonly in patients who have advanced colorectal cancer, the different palliative interventions that are available, and the available QOL data issues that pertain to these patients. PALLIATIVE CHEMOTHERAPY FOR ADVANCED COLORECTAL CANCER Palliative chemotherapy has been defined as ‘‘the use of antineoplastic medication to affect the cancer and to reduce the adverse signs and symptoms caused either directly or indirectly by the malignant disease process’’ [43]. The objective of palliative chemotherapy in patients who have advanced colorectal disease is to prolong survival and to maintain or improve the patient QOL by systemically treating the effects of the disease. However, chemotherapy in these patients can improve QOL by reducing symptoms, or it can diminish QOL as a result of therapy-related toxic effects [1]. For several years, fluorouracil was the mainstay of palliative chemotherapy regimens. Recently, more potent and effective chemotherapy agents, such as irinotecan and oxaliplatin, oral agents such as capecitabine, and biologic agents such as Bevacizumab, have been developed. Although these agents have resulted in comparable and, in certain situations, even improved median survival compared with traditional fluorouracil-based regimens, they are also associated

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with much more significant toxicities and side effects, which can have an adverse impact on patient QOL. Best Supportive Care In a randomized trial [44] comparing best supportive care to a combination chemotherapy consisting of 5-fluorouracil, leucovorin, and cisplatin in terms of overall survival and QOL, the median survival was found to be significantly longer for patients receiving chemotherapy (11 months) compared with patients receiving supportive care alone (5 months). Patient QOL was assessed with the functional living index of cancer (FLIC). The FLIC is a 22-item self-report scale developed for patients who have cancer. It provides a single QOL score based on indices of perceived well being, psychologic state, and sociability. Despite mild-to-moderate treatment-related gastrointestinal side effects, QOL was preserved in patients who received chemotherapy, and no differences in QOL scores were seen between the two groups [44]. In another study [45], patients who had metastatic colorectal cancer were randomized to either irinotecan (300–350 mg/m2 every 3 weeks) with supportive care or supportive care alone. Primary endpoints in this trial were overall survival, whereas secondary endpoints included the affect of treatment on performance status, tumor-related symptoms, and patient QOL. QOL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) questionnaire (which includes five function scales, one global health status scale, and nine symptom scales). This study showed that treatment with irinotecan and supportive care, compared with supportive care alone, prolonged the survival of patients who had metastatic colorectal cancer (1-year survival probability of 15.4% versus 7.9%), yet the treatment group had fewer tumor-related symptoms and a better QOL. Irinotecan also improved the symptoms of patients and delayed the tumor-related symptoms such as performance status deterioration, weight loss, and pain. Fluorouracil-based Regimens Fluorouracil-based regimens have been the mainstay of chemotherapy treatment of patients who have advanced colorectal cancer for almost 3 decades. In vitro and in vivo evidence has suggested that fluorouracil has a scheduledependent mechanism of action [46]. As a result, various administration regimens were developed that were either bolus-based, such as the North Central Cancer Treatment Group (NCCTG)-Mayo regimen, or infusion-based, such as the de Gramont regimen [47]. In a comparison of these two treatment regimens, the de Gramont regimen had a median survival rate that was similar to the NCCTG regimen but had reduced toxic effects [48]. In a randomized comparison of survival, symptom palliation, and QOL among three chemotherapy regimens, Maughan and colleagues [47] reported that the de Gramont and Lokich regimens were similar in terms of survival, disease response rates, and QOL, but the Lokich regimen was associated with more central line complications and hand-foot syndrome. Raltitrexed therapy showed response rates and overall survival that were similar to other regimens but resulted in greater

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toxicity and inferior QOL. Patient QOL was assessed with the EORTC QLQC30, plus six study-specific questionnaires and the 14-item HAD scale. In a meta-analysis conducted by the Cancer Collaborative Group [41] of palliative chemotherapy trials for advanced colorectal cancer, the majority of which were fluorouracil-based, chemotherapy was shown to prolong the time to disease progression and overall survival; however, the evidence to indicate a benefit on QOL was inadequate. Irinotecan and Oxaliplatin Several phase III trials have now shown that irinotecan with fluorouracil and leucovorin compared with fluorouracil and leucovorin alone improved response rates and progression-free survival, and two of these trials have shown significantly longer overall survival. Although the comparison of fluorouracil and leucovorin alone and in combination with oxaliplatin has demonstrated a higher response rate and progression-free survival, no survival advantage was seen for the combination therapy. The NCCTG trial N9741 [49] was designed to address the question as to which of the two agents, oxaliplatin or irinotecan, should be used as a first-line therapy in metastatic colorectal cancer. In this trial, combination therapies using irinotecan and bolus fluorouracil plus leucovorin (IFL), oxaliplatin and infused fluorouracil plus leucovorin (FOLFOX), and irinotecan and Oxaliplatin (IROX) were compared in patients who had previously untreated metastatic colorectal cancer. The FOLFOX regimen, with a median time to progression of 8.7 months, response rates of 45%, and median survival time of 19.5 months, was found to be superior to the other treatment arms. The use of these agents and even newer agents, such as antiangiogenic agents and oral fluoropyrimidines, are likely to change the management strategies of these patients. Although to date the conventional oncologic endpoints such as response rates, progression-free survival, and overall survival have been evaluated rigorously, QOL outcomes have received much less attention. This outcome is particularly relevant in patients who have advanced disease because these agents have side effects and are associated with toxicities, which can adversely impact patient QOL. Irinotecans are associated with late onset diarrhea, which is dose limiting, whereas the neurotoxicity associated with oxaliplatin limits its use at higher doses and is cumulative. Therefore, although these treatment regimens may offer benefits in terms of oncologic endpoints, the quality of this survival has yet to be assessed. Recently, using data from the N9741 trial [50], it was demonstrated that clinically meaningful changes in simple, single-item patientreported assessments of peripheral neuropathy could identify problems 2 to 3 months before the routinely collected physician-completed National Cancer Institute common toxicity criteria reported an adverse event. SURGICAL VERSUS ENDOSCOPIC INTERVENTIONS FOR OBSTRUCTING COLORECTAL CANCER Patients with metastatic disease that presents with a symptomatic bowel obstruction caused by the primary tumor traditionally underwent either

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a laparotomy for resection of the primary tumor, an intestinal bypass, or a nonfunctioning stoma to alleviate the obstructing symptoms. This operative approach was associated with significant postoperative morbidity (20%–30%) and mortality (5%–10%). A contemporary surgical series of 120 patients who had advanced colorectal disease reported a 5.8% postoperative mortality rate and a 20% complication rate, in which the most common complication was a wound infection. During the last few years, self-expanding metal stents have been used increasingly in such patients. Most of the reports on metal stents have reported its efficacy in palliating intestinal obstruction, with minimal procedure-related complications. A cohort study that examined outcomes after stent placement and a laparotomy did not show any difference in survival between the two groups [51]. Patients who underwent stent procedures had no postprocedural complications and were discharged earlier from the hospital than patients who underwent a laparotomy. The authors speculated that patients undergoing a stent placement recovered earlier to their premorbid state, although no formal evaluation was performed to measure this outcome. A systemic review of the efficacy and safety of colorectal stents has reported a 16% incidence of obstruction among patients undergoing stent placement for palliation, although Hunberbein and colleagues [52] reported that 18% of their patients who underwent stent placement for malignant rectal obstruction subsequently required surgical palliation because of the failure of stent treatment. Both surgical and endoscopic modalities aim at relieving the symptoms of intestinal obstruction. Clearly, although surgery is a definitive option, it is associated with significant postoperative complications that can potentially influence patient QOL, whereas stenting, although less morbid, has a significant incidence of malfunction. How these factors affect patient QOL has not been assessed. MULTIMODALITY THERAPY FOR RECURRENT RECTAL CANCER Patients undergoing potentially curative resection for rectal cancer have a 4% to 30% risk of developing locoregional pelvic recurrence, with 40% to 50% of these occurring in the absence of systemic disease [53,54]. Without treatment, the median survival of such patients is 3.5 to 6 months and is associated with debilitating pelvic and perineal pain, bowel dysfunction, and presumed impairment of QOL. Recently, with a multimodality approach that includes radical surgery and intraoperative radiotherapy (IORT), 5-year survival rates of 21% to 58% have been reported [53–57]. As a continuation of this benefit, it is assumed that multimodality treatment also improves functional outcomes and restores QOL by definitively treating recurrent pelvic disease. Critics of this approach, however, would argue that the improvement in survival is obtained at a cost of diminished QOL because the significant postoperative morbidity and disability associated with this approach negates any quantitative survival advantage. The potential causes of this impairment in QOL after multimodality treatment can be multifactorial and includes high-dose preoperative radio- and

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chemotherapy, radical surgery, and IORT. The pelvic recurrences usually involve the adjacent viscera or bony structures in the pelvis; therefore, curative surgery often requires the resection of the adjacent organs such as the bladder or neurovascular structures and creation of ostomies and bone resections, all of which can affect functional outcome. Peripheral nerve neuropathy is the main dose-limiting side effect of IORT, whereas External Beam Radiation Therapy is known for its long-term adverse effects on bowel and urogenital function [58]. A review of the literature suggests that there are limited data on the functional outcomes and QOL of patients who undergo therapy for recurrent rectal cancer [59–62]. In fact, little is known about the impact of pelvic recurrence of rectal cancer on patient QOL and the subsequent affect on QOL after multimodality treatment. More work is needed, particularly in this area. SUMMARY QOL assessment in oncology has made great strides in recent years. There was a difficult time initially, during which QOL tools were ‘‘thrown in’’ to many clinical trials as an afterthought, without a pre-specified scientific question. As expected from such a scattershot approach, the results were underwhelming and disappointing. The disappointing results from this period led many practitioners to question the value added by QOL assessment in oncology clinical trials. This healthy skepticism has led to a renaissance period, in which situation-specific and disease-specific QOL assessments have been developed and have contributed substantial information to the cause of the disease, the effects of treatments, and the experiences of cancer patients. Today, there is a dawning recognition that asking the patient directly about their QOL using the same scientific rigor required of other clinical outcomes can provide valuable data for prognosis, treatment, symptom management, and supportive care. With time and further successful experiences like those cited in this article, QOL assessment may eventually become as routinely collected and integrated into oncology clinical practice as pain and blood pressure assessments are today. References [1] Michael M, Tannock IF. Measuring health-related quality of life in clinical trials that evaluate the role of chemotherapy in cancer treatment. CMAJ 1998;158(13):1727–34. [2] Osse BH, Vernooij MJ, Schade E, et al. Towards a new clinical tool for needs assessment in the palliative care of cancer patients: the PNPC instrument. J Pain Symptom Manage 2004;28(4):329–41. [3] World Health Organization. Technical report series 804. In: Cancer Pain and Palliative Care. Geneva: World Health Organization; 1990. p. 11. [4] Jacobsen PB, Weitzner MA. Evaluation of palliative endpoints in oncology clinical trials. Cancer Control 1999;6(5):471–7. [5] Brady MJ, Cella D. Assessing quality of life in palliative care. Cancer Treat Res 1999;100: 203–16. [6] Cella DF. Quality of life: the concept. J Palliat Care 1992;8(3):8–13. [7] Whalen GF, Ferrans CE. Quality of life as an outcome in clinical trials and cancer care: a primer for surgeons. J Surg Oncol 2001;77(4):270–6.

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[8] Frost MH, Sloan JA. Quality of life measurements: a soft outcome—or is it? Am J Manag Care 2002;8(Suppl 18):S574–9. [9] Cella DF. Quality of life outcomes: measurement and validation. Oncology 1996;10 (Suppl 11):S233–46. [10] Cohen SR. Defining and measuring quality of life in palliative care. Journal of Palliative Care 2001;5:137–56. [11] Dijkers M. Measuring quality of life: methodological issues. Am J Phys Med Rehabil 1999;78(3):286–300. [12] Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res 1995;4(6):523–31. [13] National Institutes of Health Consensus Development Program. Draft statement, symptom management in cancer: pain, depression, and fatigue. Statement of the Science Conference: July 15–17, 2002. [14] Chassany O, Sagnier P, Marquis P, et al. Patient reported outcomes: the example of health related quality of life - a european guidance for the improved integration of HRQoL assessment in the drug regulatory process. Drug Inf J 2002;36:209–38. [15] Fayers PM, Hopwood P, Harvey A, et al. Quality of life assessment in clinical trials–guidelines and a checklist for protocol writers: the UK medical research council experience. Eur J Cancer 1997;33(1):20–8. [16] Sloan JA, Cella D, Frost M, et al, for the Clinical Significance Consensus Meeting Group. Assessing clinical significance in measuring oncology patient quality of life. Mayo Clin Proc 2002;77:367–70. [17] Sloan JA, Aaronson N, Cappelleri JC, et al, for the Clinical Significance Consensus Meeting Group. Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc 2002;77:479–87. [18] Sloan JA, Loprinzi CL, Kuross SA, et al. Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol 1998;16:3662–73. [19] Sloan J, Symonds T, Vargas-Chanes D, et al. Practical guidelines for assessing the clinical significance of health-related quality of life changes within clinical trials. Drug Inf J 2003;37:23–31. [20] Sloan JA. Assessing the minimally clinically significant difference: scientific considerations, challenges and solutions. Journal of Chronic Obstructive Pulmonary Disease 2005;2: 57–62. [21] Sloan JA, Vargas-Chanes D, Kamath CC, et al. Detecting worms, ducks and elephants: a simple approach for defining clinically relevant effects in quality-of-life measures. J Cancer Integrative Medicine 2003;1(1):41–7. [22] Guyatt GH, Osoba D, Wu AW, et al, for the Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002;77(4):371–83. [23] Norman GR, Sloan JA, Wyrwich KW. The truly remarkable universality of half a standard deviation: confirmation through another look. Expert Review of Pharmacoeconomics and Outcomes Research 2004;4(5):515–9. [24] Sloan JA, Dueck A. Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials. J Biopharm Stat 2004;14(1):73–96. [25] Sloan JA, Dueck A, Frost M, et al. Solutions for assessing quality of life in cancer research and clinical practice: part 1. Curr Probl Cancer 2005;29:265–351. [26] Osoba D, Bezjak A, Brundage M, et al, for the Quality of Life Committee of the NCIC CTG. Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer 2005;41(2):280–7. [27] Bottomley A, Vanvoorden V, Flechtner H, et al, for the EORTC Quality of Life Group EORTC Data Center. The challenges and achievements involved in implementing quality of life research in cancer clinical trials. Eur J Cancer 2003;39(3):275–85.

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[28] Osoba DA. Taxonomy of the uses of health-related quality-of-life instruments in cancer care and the clinical meaningfulness of the results. Med Care 2002;40(Suppl 6):SIII-31–III-8. [29] Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 1993;11:570–9. [30] Yellen SB, Cella DF, Webster K, et al. Measuring fatigue and other anemia-related symptoms with the functional assessment of cancer therapy (FACT) measurement system. J Pain Symptom Manage 1997;13(2):63–74. [31] Kozelsky TF, Meyers GE, Sloan JA, et al. Phase 3 double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. J Clin Oncol 2003;21(9):1669–74. [32] De Haes J, Curran D, Young T, et al. Quality of life evaluation in oncological clinical trials: the EORTC model. Eur J Cancer 2000;36:821–5. [33] Mendoza TR, Wang XS, Cleeland CS, et al. The rapid assessment of fatigue severity in cancer patients: use of the brief fatigue inventory. Cancer 1999;85(5):1186–96. [34] Ahlberg K, Ekman T, Gaston-Johansson F, et al. Assessment and management of cancerrelated fatigue in adults. Lancet 2003;362:640–50. [35] Bjelland I, Dahl AA, Tangen Haug T, et al. The validity of the hospital anxiety and depression scale: an updated literature review. J Psychosom Res 2002;52:69–77. [36] McNair DM, Lorr M, Droppleman LF. Edits manual for the profile of mood states [revised 1992]. San Diego (CA): Edits/Educational and Industrial Testing Service; 1992. [37] Sloan JA, et al. Quality of life, spirituality, and mayo franciscan values: a research perspective. Mayo Clin Proc, in press. [38] Ware JE Jr, Gandek V, Kosinski M, et al. The equivalence of SF-36 summary health scores estimated using standard and country-specific algorithms in 10 countries: results from the IQOLA project. J Clin Epidemiol 1998;51(11):1167–70. [39] Ware JE Jr, Kosinski M, Keller SD. A 12-item short-form health survey. Med Care 1996;34: 220–33. [40] Rosen SA, Buell JF, Yoshida A, et al. Initial presentation with stage IV colorectal cancer: how aggressive should we be? Arch Surg 2000;135(5):530–5 [discussion: 534–5]. [41] Amersi F, Stamos MJ, Ko CY. Palliative care for colorectal cancer. Surg Oncol Clin N Am 2004;13(3):467–77. [42] Simmonds PC, for the Colorectal Cancer Collaborative Group. Palliative chemotherapy for advanced colorectal cancer: systematic review and meta-analysis. BMJ 2000;321(7260): 531–5. [43] Ellison NM. Palliative chemotherapy. Am J Hosp Palliat Care 1998;15(2):93–103. [44] Scheithauer W, Rosen H, Kornek GV, et al. Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. BMJ 1993;306(6880):752–5. [45] Cunningham D, Pyrhonen S, James RD, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 1998;352(9138):1413–8. [46] Sobrero AF, Aschele C, Bertino JR. Fluorouracil in colorectal cancer–a tale of two drugs: implications for biochemical modulation. J Clin Oncol 1997;15(1):368–81. [47] Maughan TS, James RD, Kerr DJ, et al. Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet 2002;359(9317):1555–63. [48] de Gramont A, Bosset JF, Milan C, et al. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 1997;15(2):808–15. [49] Goldberg RM, Sargent DJ, Morton RF, et al. A randomized control trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004;22:23–30.

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[50] Morton RF, Sloan JA, Grothey A, et al. A comparison of simple single-item measures and the common toxicity criteria in detecting the onset of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. ASCO. Orlando, Florida; May 13-17, 2005. Abstract 8087. [51] Carne PW, Frye JN, Robertson GM, et al. Stents or open operation for palliation of colorectal cancer: A retrospective, cohort study of perioperative outcome and long-term survival. Diseases of the Colon & Rectum 2004;47(9):1455–61. [52] Hunerbein M, Krause M, Moesta KT, et al. Palliation of malignant rectal obstruction with selfexpanding metal stents. Surgery 2005;137:42–7. [53] Mannaerts GH, Martijn H, Crommelin MA, et al. Intraoperative electron beam radiation therapy for locally recurrent rectal carcinoma. Int J Radiat Oncol Biol Phys 1999;45(2): 297–308. [54] Miller AR, Cantor SB, Peoples GE, et al. Quality of life and cost effectiveness analysis of therapy for locally recurrent rectal cancer. Dis Colon Rectum 2000;43(12):1695–703. [55] Mannaerts GH, Rutten HJ, Martijn H, et al. Comparison of intraoperative radiation therapycontaining multimodality treatment with historical treatment modalities for locally recurrent rectal cancer. Dis Colon Rectum 2001;44(12):1749–58. [56] Lindel K, Willett CG, Shellito PC, et al. Intraoperative radiation therapy for locally advanced recurrent rectal or rectosigmoid cancer. Radiother Oncol 2001;58(1):83–7. [57] Hahnloser D, Haddock MG, Nelson H. Intraoperative radiotherapy in the multimodality approach to colorectal cancer. Surg Oncol Clin N Am 2003;12(4):993–1013. [58] Shoup M, Guillem JG, Alektiar KM, et al. Predictors of survival in recurrent rectal cancer after resection and intraoperative radiotherapy. Dis Colon Rectum 2002;45(5):585–92. [59] Wiig JN, Poulsen JP, Tveit KM, et al. Intra-operative irradiation (IORT) for primary advanced and recurrent rectal cancer: a need for randomised studies. Eur J Cancer 2000;36(7): 868–74. [60] Mannaerts GH, Rutten HJ, Martijn H, et al. Effects on functional outcome after IORT-containing multimodality treatment for locally advanced primary and locally recurrent rectal cancer. Int J Radiat Oncol Biol Phys 2002;54(4):1082–8. [61] Esnaola NF, Cantor SB, Johnson ML, et al. Pain and quality of life after treatment in patients with locally recurrent rectal cancer. J Clin Oncol 2002;20(21):4361–7. [62] Shibata D, Guillem JG, Lanouette N, et al. Functional and quality-of-life outcomes in patients with rectal cancer after combined modality therapy, intraoperative radiation therapy, and sphincter preservation. Dis Colon Rectum 2000;43(6):752–8.

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Endoscopic Approaches for Palliation of Luminal Gastrointestinal Obstruction Douglas G. Adler, MD*, Shehzad N. Merwat, MD Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Texas–Houston Medical School, MSB 4.234, 6431 Fannin, Houston, TX 77030, USA

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s of this writing, much of the workload of a typical gastroenterologist is devoted to screening patients for gastrointestinal malignancies. Efforts such as colorectal cancer screening via colonoscopy and endoscopic surveillance of patients with Barrett’s esophagus are widespread and widely endorsed. These programs go forward in hopes of diagnosing patients with malignancies while the lesions are still treatable and curable. Despite such efforts, advanced gastrointestinal cancers still are encountered frequently in clinical practice. The malignancies often lead to obstructive symptoms in the gastrointestinal tract, either by direct blockage of the luminal gut (esophageal cancer leading to dysphagia) or by extrinsic compression (pancreatic cancer causing duodenal compression and malignant gastric outlet obstruction [GOO]). In recent years, the armamentarium of endoscopy has broadened considerably and now affords physicians a variety of nonsurgical means to palliate malignant obstruction of the gastrointestinal tract. This article reviews endoscopic techniques to treat malignant esophageal, biliary, small bowel, and colonic obstruction. ENDOSCOPIC PALLIATION OF ESOPHAGEAL OBSTRUCTION Esophageal cancer is the seventh leading cause of cancer-related death in the United States and worldwide. The incidence of adenocarcinoma of the esophagus is increasing in most developed countries [1]. Despite advances in therapy, more than 50% of esophageal cancers are incurable at presentation, and the 5year survival rate is less than 10%. Palliative therapy for dysphagia is a primary concern in the care of these patients. An ideal palliative therapy would result in complete resolution of dysphagia relatively quickly and with minimal complications. Many therapeutic options exist, although all have limitations. The relief of dysphagia often is measured subjectively by the use of a ‘‘dysphagia score.’’ Most studies use a dysphagia score similar to, if not the same as,

*Corresponding author. E-mail address: [email protected] (D.G. Adler). 0889-8553/06/$ – see front matter doi:10.1016/j.gtc.2005.12.004

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the system described by Mellow and Pinkas [2]: A score of 0 denotes the ability to eat a normal diet; 1, the ability to eat some solid food; 2, the ability to eat semisolids only; 3, the ability to swallow liquids only; and 4, complete dysphagia. Endoscopic Methods Alcohol injection Direct injection of pure ethanol into malignant tissue is the simplest and least expensive technique that can be used to recanalize an obstructed esophagus. Alcohol can be injected under endoscopic visualization to cause tumor ulceration and necrosis. It has proved to be an effective modality in the relief of malignant dysphagia. Significant relief of dysphagia was found in two uncontrolled trials [3,4]. In a randomized, controlled trial comparing neodymium:yttrium-aluminum-garnet (Nd:YAG) laser with ethanol injection, the dysphagiafree interval was 37 days and 30 days. An improvement in the dysphagia score of at least 2 points was noted in 88% of the laser group and 78% of the ethanol group, and there was no difference in median survival [5]. Laser therapy Laser therapy involves the use of laser light to coagulate tissue under endoscopic guidance. The most common device used in endoscopy is the Nd:YAG laser. It has proved to be an effective modality in the treatment of malignant esophageal obstruction, and success rates of 75% to 91% have been reported [6–8]. Repeat treatment (sometimes frequent) is necessary in about 50% of all patients [6,7]. Complications include perforation, bleeding, and the formation of tracheoesophageal fistulas and occur in 4% to 20% of patients [9]. Laser therapy involves the use of expensive hardware that requires periodic maintenance, and the overall cost of laser treatment is the same as, if not greater than, treatment with other modalities, including stenting [10,11]. As such, laser therapy is performed less commonly than in years past. Laser therapy can be used, however, for proximal esophageal lesions for which stenting is not feasible. Argon plasma coagulation Argon plasma coagulation is a type of monopolar coagulation based principally on the effects of high-frequency electrical current flowing through a conductive, ionized argon medium. This technique destroys tissue to a depth of 2 to 3 mm and is most useful in superficial lesions. Several studies have been performed to assess its effectiveness in the palliation of malignant dysphagia. In one restrospective study of 32 patients, recanalization was achieved in 89% of patients [12]. A separate report of 83 patients found a similar recanalization rate of 86% [13]. Most of these patients required multiple sessions to maintain patency, averaging five to six sessions per patient, usually at an interval of 3 to 4 weeks [14,15]. Perforation was seen in 1% to 1.8% of procedures, a rate comparable to that seen in other modalities [14,15]. Argon plasma coagulation seems to be a safe and easy alternative to laser treatment; further prospective trials are needed for comparison.

ENDOSCOPIC PALLIATION

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Photodynamic therapy Photodynamic therapy is an ablative technique using photosensitive agents that are administered to the patient and activated by a specific wavelength of light. As the photosensitive agent is activated, it generates cytotoxic oxygen species, which induce cell necrosis and death. The photosensitive agent has a tropism for faster growing malignant cancer cells or simply may be retained in these tissues owing to poor lymphatic drainage. Activation causes tumor necrosis resulting in a debulking effect that restores luminal patency. Response rates were measured by a subjective improvement in the patient’s dysphagia score in several uncontrolled trials, with patient-reported response rates varying from 70% to 100% [14–17]. The two largest studies narrow this range, however, to 70% to 85% [14,17]. Nineteen percent to 38% of patients required a second photodynamic therapy course, and the dysphagia-free interval ranged from 66 to 80 days [15,17]. In a randomized, controlled trial, 108 patients who underwent Nd:YAG laser therapy were found to have a perforation rate of 7% compared with a 1% perforation rate in 110 patients who underwent treatment with photodynamic therapy (P