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Mipomersen Cut LDL Cholesterol Levels in Statin-Resistant Patients
NEW ORLEANS – In patients with hypercholesterolemia and high cardiovascular risk, the novel agent mipomersen administered as add-on therapy led to robust reductions in LDL cholesterol, based on the results of a double-blind, phase III study presented at the annual scientific sessions of the American College of Cardiology.
"In high-risk patients refractory to maximally tolerated statin therapy, the addition of mipomersen significantly reduced LDL-C and other atherogenic lipids and lipoproteins," said Dr. William C. Cromwell of the Presbyterian Cardiovascular Institute in Charlotte, N.C.
Mipomersen is the first of a new class of agents called apolipoprotein B (apoB) synthesis inhibitors. In the study, the drug was administered subcutaneously once a week. Among its side effects were injection site reactions, increases in alanine aminotransferase (ALT) levels, and steatosis.
The study included 158 patients at high risk for cardiovascular events who were unable to achieve target LDL-C levels with statins, bile-acid sequestrants, and niacin. At baseline, all patients were on maximally tolerated doses of a statin; 63 were on the maximal approved dose, and 25 were also receiving ezetimibe.
All subjects had LDL-C levels of at least 100 mg/dL and triglycerides below 200 mg/dL. They were randomized 2:1 to 200 mg subcutaneous mipomersen or placebo weekly for 26 weeks. The primary end point was percent change in LDL-C from baseline at week 28 or 2 weeks after the last dose if treatment was not completed.
LDL-C levels of less than 100 mg/dL were achieved by 77 (76%) mipomersen-treated patients, compared with 19 (38%) placebo-treated patients. LDL-C levels of less than 70 mg/dL were achieved by 51 (50%) and 4 (8%), respectively.
The percent reduction in LDL cholesterol from baseline to the primary efficacy time point was a 37% drop in the mipomersen arm and a 5% drop in the placebo arm, a significant difference.
"LDL-C levels decreased through the first 17 weeks of treatment and remained relatively low through week 28," Dr. Cromwell observed. "Mipomersen’s lipid-lowering effects were independent of baseline LDL-C or race, and were similar for patients with and without diabetes."
The effect of the drug in the diabetic subset was robust. In the diabetes cohort, the mean decline in LDL-C from baseline was 51% for the 56 patients on mipomersen and 32% for the 29 on placebo.
Dr. Cromwell noted that the drug had a more pronounced effect in females and in patients whose age was above the median. However, mipomersen’s effects in males and in younger persons were still statistically significant and clinically meaningful.
Mipomersen also was associated with significant reductions from baseline values in apoB (38%), total cholesterol (26%), non-HDL cholesterol (36%), and lipoprotein(a) (24%). HDL-C levels did not change significantly from baseline.
Sixty of the 105 mipomersen-treated patients (57%) and 44 of 52 placebo patients (85%) completed treatment. A total of 26 mipomersen-treated patients and 2 placebo-treated patients discontinued due to on-treatment adverse events. Of the mipomersen noncompleters, seven discontinued due to a liver enzyme-related adverse event, and seven stopped because of an injection site reaction.
Injection site reactions were the most common adverse event, occurring in 78% of the mipomersen group and 31% of the placebo group. Flu-like symptoms occurred in 34% and 21%, respectively.
"Injection site reaction is the biggest side effect with this drug. This ranges from induration to redness, and some patients have skin discoloration. It’s real, and it does have to be managed," Dr. Cromwell acknowledged.
ALT elevations at least 3 times the upper limit of normal were observed in 14% of patients on mipomersen, versus none receiving placebo, but this occurred without concomitant significant bilirubin elevations, he said. For 10% of patients, ALT elevations occurred on consecutive measurements at least 7 days apart. One patient had an ALT of at least 10 times the upper limit of normal.
"We don’t see this as a huge ALT signal," Dr. Cromwell pointed out. "This is against the backdrop of a statin, which is already sensitizing the liver. We think it’s reassuring."
Approximately one-third of patients had an increase in steatosis, defined as liver fat increasing by at least 5%; median percent change from baseline was 15%. "This does not represent a huge accumulation of fat. Instead, it is a signal that it’s there at 28 weeks, and it is not particularly worrying. In a series of patients with much longer exposures, there is a plateau in this increase."
Dr. Patrick Moriarty, a lipid specialist who is assistant professor of medicine at the University of Kansas, Kansas City, commented, "We treat many refractory patients, and I can tell you that a drug of this class is very much needed in this patient population. It will help get their lipid numbers down."
The fact that patients achieve good LDL-C reductions on top of statin therapy is very encouraging, he said, noting, "The drug is not for every patient, but it could fill the need for an effective treatment in a small subset."
In Dr. Moriarty’s opinion, the injectable delivery will not be a barrier to acceptance. "It could be a problem for some patients and physicians, but patients can do these injections themselves, just like diabetes patients do. In studies I’ve participated in, we offer patients the opportunity to have the nurse give them the injections but most patients learn to do [the injections] themselves."
The study was sponsored by Isis Pharmaceuticals and Genzyme Corporation. Dr. Cromwell has received consultant fees or honoraria from Isis. Dr. Moriarty has participated in clinical trials of mipomersen.
NEW ORLEANS – In patients with hypercholesterolemia and high cardiovascular risk, the novel agent mipomersen administered as add-on therapy led to robust reductions in LDL cholesterol, based on the results of a double-blind, phase III study presented at the annual scientific sessions of the American College of Cardiology.
"In high-risk patients refractory to maximally tolerated statin therapy, the addition of mipomersen significantly reduced LDL-C and other atherogenic lipids and lipoproteins," said Dr. William C. Cromwell of the Presbyterian Cardiovascular Institute in Charlotte, N.C.
Mipomersen is the first of a new class of agents called apolipoprotein B (apoB) synthesis inhibitors. In the study, the drug was administered subcutaneously once a week. Among its side effects were injection site reactions, increases in alanine aminotransferase (ALT) levels, and steatosis.
The study included 158 patients at high risk for cardiovascular events who were unable to achieve target LDL-C levels with statins, bile-acid sequestrants, and niacin. At baseline, all patients were on maximally tolerated doses of a statin; 63 were on the maximal approved dose, and 25 were also receiving ezetimibe.
All subjects had LDL-C levels of at least 100 mg/dL and triglycerides below 200 mg/dL. They were randomized 2:1 to 200 mg subcutaneous mipomersen or placebo weekly for 26 weeks. The primary end point was percent change in LDL-C from baseline at week 28 or 2 weeks after the last dose if treatment was not completed.
LDL-C levels of less than 100 mg/dL were achieved by 77 (76%) mipomersen-treated patients, compared with 19 (38%) placebo-treated patients. LDL-C levels of less than 70 mg/dL were achieved by 51 (50%) and 4 (8%), respectively.
The percent reduction in LDL cholesterol from baseline to the primary efficacy time point was a 37% drop in the mipomersen arm and a 5% drop in the placebo arm, a significant difference.
"LDL-C levels decreased through the first 17 weeks of treatment and remained relatively low through week 28," Dr. Cromwell observed. "Mipomersen’s lipid-lowering effects were independent of baseline LDL-C or race, and were similar for patients with and without diabetes."
The effect of the drug in the diabetic subset was robust. In the diabetes cohort, the mean decline in LDL-C from baseline was 51% for the 56 patients on mipomersen and 32% for the 29 on placebo.
Dr. Cromwell noted that the drug had a more pronounced effect in females and in patients whose age was above the median. However, mipomersen’s effects in males and in younger persons were still statistically significant and clinically meaningful.
Mipomersen also was associated with significant reductions from baseline values in apoB (38%), total cholesterol (26%), non-HDL cholesterol (36%), and lipoprotein(a) (24%). HDL-C levels did not change significantly from baseline.
Sixty of the 105 mipomersen-treated patients (57%) and 44 of 52 placebo patients (85%) completed treatment. A total of 26 mipomersen-treated patients and 2 placebo-treated patients discontinued due to on-treatment adverse events. Of the mipomersen noncompleters, seven discontinued due to a liver enzyme-related adverse event, and seven stopped because of an injection site reaction.
Injection site reactions were the most common adverse event, occurring in 78% of the mipomersen group and 31% of the placebo group. Flu-like symptoms occurred in 34% and 21%, respectively.
"Injection site reaction is the biggest side effect with this drug. This ranges from induration to redness, and some patients have skin discoloration. It’s real, and it does have to be managed," Dr. Cromwell acknowledged.
ALT elevations at least 3 times the upper limit of normal were observed in 14% of patients on mipomersen, versus none receiving placebo, but this occurred without concomitant significant bilirubin elevations, he said. For 10% of patients, ALT elevations occurred on consecutive measurements at least 7 days apart. One patient had an ALT of at least 10 times the upper limit of normal.
"We don’t see this as a huge ALT signal," Dr. Cromwell pointed out. "This is against the backdrop of a statin, which is already sensitizing the liver. We think it’s reassuring."
Approximately one-third of patients had an increase in steatosis, defined as liver fat increasing by at least 5%; median percent change from baseline was 15%. "This does not represent a huge accumulation of fat. Instead, it is a signal that it’s there at 28 weeks, and it is not particularly worrying. In a series of patients with much longer exposures, there is a plateau in this increase."
Dr. Patrick Moriarty, a lipid specialist who is assistant professor of medicine at the University of Kansas, Kansas City, commented, "We treat many refractory patients, and I can tell you that a drug of this class is very much needed in this patient population. It will help get their lipid numbers down."
The fact that patients achieve good LDL-C reductions on top of statin therapy is very encouraging, he said, noting, "The drug is not for every patient, but it could fill the need for an effective treatment in a small subset."
In Dr. Moriarty’s opinion, the injectable delivery will not be a barrier to acceptance. "It could be a problem for some patients and physicians, but patients can do these injections themselves, just like diabetes patients do. In studies I’ve participated in, we offer patients the opportunity to have the nurse give them the injections but most patients learn to do [the injections] themselves."
The study was sponsored by Isis Pharmaceuticals and Genzyme Corporation. Dr. Cromwell has received consultant fees or honoraria from Isis. Dr. Moriarty has participated in clinical trials of mipomersen.
NEW ORLEANS – In patients with hypercholesterolemia and high cardiovascular risk, the novel agent mipomersen administered as add-on therapy led to robust reductions in LDL cholesterol, based on the results of a double-blind, phase III study presented at the annual scientific sessions of the American College of Cardiology.
"In high-risk patients refractory to maximally tolerated statin therapy, the addition of mipomersen significantly reduced LDL-C and other atherogenic lipids and lipoproteins," said Dr. William C. Cromwell of the Presbyterian Cardiovascular Institute in Charlotte, N.C.
Mipomersen is the first of a new class of agents called apolipoprotein B (apoB) synthesis inhibitors. In the study, the drug was administered subcutaneously once a week. Among its side effects were injection site reactions, increases in alanine aminotransferase (ALT) levels, and steatosis.
The study included 158 patients at high risk for cardiovascular events who were unable to achieve target LDL-C levels with statins, bile-acid sequestrants, and niacin. At baseline, all patients were on maximally tolerated doses of a statin; 63 were on the maximal approved dose, and 25 were also receiving ezetimibe.
All subjects had LDL-C levels of at least 100 mg/dL and triglycerides below 200 mg/dL. They were randomized 2:1 to 200 mg subcutaneous mipomersen or placebo weekly for 26 weeks. The primary end point was percent change in LDL-C from baseline at week 28 or 2 weeks after the last dose if treatment was not completed.
LDL-C levels of less than 100 mg/dL were achieved by 77 (76%) mipomersen-treated patients, compared with 19 (38%) placebo-treated patients. LDL-C levels of less than 70 mg/dL were achieved by 51 (50%) and 4 (8%), respectively.
The percent reduction in LDL cholesterol from baseline to the primary efficacy time point was a 37% drop in the mipomersen arm and a 5% drop in the placebo arm, a significant difference.
"LDL-C levels decreased through the first 17 weeks of treatment and remained relatively low through week 28," Dr. Cromwell observed. "Mipomersen’s lipid-lowering effects were independent of baseline LDL-C or race, and were similar for patients with and without diabetes."
The effect of the drug in the diabetic subset was robust. In the diabetes cohort, the mean decline in LDL-C from baseline was 51% for the 56 patients on mipomersen and 32% for the 29 on placebo.
Dr. Cromwell noted that the drug had a more pronounced effect in females and in patients whose age was above the median. However, mipomersen’s effects in males and in younger persons were still statistically significant and clinically meaningful.
Mipomersen also was associated with significant reductions from baseline values in apoB (38%), total cholesterol (26%), non-HDL cholesterol (36%), and lipoprotein(a) (24%). HDL-C levels did not change significantly from baseline.
Sixty of the 105 mipomersen-treated patients (57%) and 44 of 52 placebo patients (85%) completed treatment. A total of 26 mipomersen-treated patients and 2 placebo-treated patients discontinued due to on-treatment adverse events. Of the mipomersen noncompleters, seven discontinued due to a liver enzyme-related adverse event, and seven stopped because of an injection site reaction.
Injection site reactions were the most common adverse event, occurring in 78% of the mipomersen group and 31% of the placebo group. Flu-like symptoms occurred in 34% and 21%, respectively.
"Injection site reaction is the biggest side effect with this drug. This ranges from induration to redness, and some patients have skin discoloration. It’s real, and it does have to be managed," Dr. Cromwell acknowledged.
ALT elevations at least 3 times the upper limit of normal were observed in 14% of patients on mipomersen, versus none receiving placebo, but this occurred without concomitant significant bilirubin elevations, he said. For 10% of patients, ALT elevations occurred on consecutive measurements at least 7 days apart. One patient had an ALT of at least 10 times the upper limit of normal.
"We don’t see this as a huge ALT signal," Dr. Cromwell pointed out. "This is against the backdrop of a statin, which is already sensitizing the liver. We think it’s reassuring."
Approximately one-third of patients had an increase in steatosis, defined as liver fat increasing by at least 5%; median percent change from baseline was 15%. "This does not represent a huge accumulation of fat. Instead, it is a signal that it’s there at 28 weeks, and it is not particularly worrying. In a series of patients with much longer exposures, there is a plateau in this increase."
Dr. Patrick Moriarty, a lipid specialist who is assistant professor of medicine at the University of Kansas, Kansas City, commented, "We treat many refractory patients, and I can tell you that a drug of this class is very much needed in this patient population. It will help get their lipid numbers down."
The fact that patients achieve good LDL-C reductions on top of statin therapy is very encouraging, he said, noting, "The drug is not for every patient, but it could fill the need for an effective treatment in a small subset."
In Dr. Moriarty’s opinion, the injectable delivery will not be a barrier to acceptance. "It could be a problem for some patients and physicians, but patients can do these injections themselves, just like diabetes patients do. In studies I’ve participated in, we offer patients the opportunity to have the nurse give them the injections but most patients learn to do [the injections] themselves."
The study was sponsored by Isis Pharmaceuticals and Genzyme Corporation. Dr. Cromwell has received consultant fees or honoraria from Isis. Dr. Moriarty has participated in clinical trials of mipomersen.
FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF CARDIOLOGY
Major Finding: LDL-C levels of less than 100 mg/dL were achieved by 76% of mipomersen-treated patients, compared with 38% of placebo-treated patients. LDL-C levels of less than 70 mg/dL were achieved by 50% and 8%, respectively.
Data Source: The double-blind study included 158 high-risk patients who were unable to achieve target LDL-C levels on optimal therapy and were randomized 2:1 to 200 mg subcutaneous mipomersen or placebo weekly for 26 weeks.
Disclosures: The study was sponsored by Isis Pharmaceuticals and Genzyme Corporation. Dr. Cromwell has received consultant fees or honoraria from Isis. Dr. Moriarty has participated in clinical trials of mipomersen.
Recognizing Depression in Patients with Cancer
How we do it


Article Outline
Data summarized in an excellent review by Pirl published in 2004 show that up to one in five Americans will experience depressive symptoms over the course of their lifetime and that approximately 10%–25% of cancer patients meet criteria for clinical depression.[1] and [2] As our ability to treat depression has improved over the years, thanks in great part to advances in pharmacology and behavioral therapies, it is now critically important to recognize and treat this debilitating disease in individuals with cancer.3 Evidence exists that untreated depression is associated with a worse overall survival for some cancer patients and, paradoxically, that up to half of patients with cancer and concurrent depression are undertreated or receive no treatment.[4], [5] and [6] Medical oncologists receive little or no formal training in psycho-oncology yet are often faced with patients who exhibit changes in mood and become progressively disabled by psychiatric symptoms. Methodical assessment and frequent inquiry may identify patients with cancer and depression.
Peeling Back the Onion: Sorting through Symptoms to Reach a Diagnosis
A diagnosis of cancer often precipitates intense emotions such as fear, sadness, and sometimes anger.2 Individuals who may never have given much thought to their own death are confronted with the very real possibility of a shortened life and future suffering. Roles and relationships shift, careers are interrupted, and daily routines may be sacrificed to make room for cancer treatment. Add to this the financial worries that often accompany a serious illness and it is not surprising that patients may require some level of professional guidance or intervention in order to cope with the crisis. As a quick rule of thumb, it takes about 3–4 weeks after diagnosis to adjust, and during that period it is quite normal for patients to experience intense feelings.7 Weissman and Worden, among the first psychiatrists to study distress in cancer patients, described an acute syndrome of distress over existential plight with the diagnosis and with a recurrence that lasts about 100 days.8 Most individuals, given time and adequate support, will find the inner resources to cope with distressing symptoms and find a new normal. Not all do however, and it is important for oncologists to inquire at regular intervals about how the patient is feeling and coping with illness. A recent study by Lo et al9 found that predictors of depressive symptoms in patients with solid tumors included younger age, antidepressant use at baseline, lower self-esteem and spiritual well-being, greater attachment anxiety, hopelessness, the physical burden of symptoms, and proximity to death.
To facilitate screening for emotional distress in the context of a diagnosis of cancer, the National Comprehensive Cancer Network (NCCN) established guidelines that provide a reproducible algorithm for triaging patients with a suspected depression to mental health professionals.10 These guidelines were updated in 2010 and are widely available.11 The consensus definition of distress in cancer is “a multifactorial, unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment. Distress extends along a continuum, ranging from common feelings of vulnerability, sadness, and fears to problems that can become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.”10 By framing distress as a very broad concept, the guidelines separate the broad gamut of normal emotions from the distinct psychiatric syndromes of anxiety and depression which require specialized professional interventions.12
Distress may be a normal response to a threat or crisis, but depressive symptoms should alert the clinician that something more serious is going on. The appearance of persistent symptoms of dysphoria, hopelessness, helplessness, loss of self-esteem, feelings of worthlessness, and suicidal ideation indicates a psychiatric illness.13 The DSM-IV defines a major depressive episode as experiencing either dysphoria or anhedonia in addition to at least five somatic symptoms for at least 2 weeks.14 These somatic symptoms may well overlap with those experienced by patients as a direct result of their cancer or its treatment. Among these are changes in appetite, weight, or sleep; fatigue; loss of energy; and a diminished ability to think or concentrate. The challenge for clinicians is to tease apart the physiologic consequences of disease and side effects of medications from those due to profound and disabling psychiatric syndromes.
Many symptoms caused by cancer itself can be confused with neurovegetative symptoms of depression. Pain is known to modulate the reporting of symptoms; fatigue and weight changes are often secondary to cancer treatment or the illness itself. Patients often feel fatigued due to the heightened metabolic state present when there is a high burden of disease, and cytokines elevated in malignancy have been shown to cause fatigue and appetite suppression. There is a growing literature regarding the development of aberrant sleep patterns in patients with cancer, which can be mistaken for depressive daytime somnolence or insomnia.[15], [16], [17] and [18] Some cancers themselves are associated with a higher risk of depressive symptoms, including pancreatic cancer and cancers of the head and neck.[19], [20] and [21] Chemotherapy can also induce fatigue, insomnia, and anhedonia, as can the steroids often used concomitantly with chemotherapeutic or biologic agents. Interferon-alpha, used to treat melanoma and renal cell cancer, has been associated with depression in 3%–40% of patients; and there is a 5% rate of suicidal thoughts.22
Cancer patients exhibit a range of coping styles and varying degrees of emotional resiliency. If a patient is able to process his or her emotional responses to the physical threat of a diagnosis and becomes mobilized in such a way that he or she obtains useful information and is able to prioritize concerns, obtain social support, and move toward a coherent treatment plan, one can easily assume that he or she is coping well.23 On the other hand, if the patient appears unable to make a decision about treatment, avoids addressing or discussing important issues, and retreats from family, friends, and/or the medical team, one can infer that he or she is having trouble coping and could benefit from a referral to a mental health professional for evaluation.23 Known risk factors for poor coping and for developing depression include social isolation, use of few coping strategies, a history of recent losses or multiple obligations, inflexible coping strategies, the presence of pain, and socioeconomic pressures.[8] and [23] In extreme cases, patients may resort to deferring decisions or simply denying the problem.
Keep in mind there may also be cultural or personal barriers that interfere with a timely and accurate diagnosis of depression.12 Many families believe strongly in the “power of positive thinking” and need to feel that their family member is a “fighter.” This type of encouragement may at times be helpful for a patient, but it may not leave a safe opening for the expression of fear, pain, or depressed mood. If the matriarch or patriarch of the family has supported everyone else through the difficulties in their lives, she or he may not feel able to show weakness and seek help for depression. This can be a difficult patient to diagnose as the only clue to suffering may be easy to miss. In fact, if there are very few questions or complaints when there is clear physical suffering, one needs to worry that the patient is unable to express his or her deep concerns. The clinician who spots this situation early on may be able to lead the patient in the direction of expressing his or her feelings by suggesting that others in similar situations also experience stress or sadness. Finding a private time to talk, away from family members, may also provide a more comfortable environment for a candid conversation.
If we think of the disease trajectory as a marathon, then we can learn to recognize certain landmarks along the course and remember that these pose enormous challenges to patients. In addition to receiving the initial diagnosis, the period of active treatment, the conclusion of active treatment, and the time of disease recurrence pose specific challenges and precipitate intense emotions. Disease recurrence is a time of great anxiety when there is a need to plan for future treatment and an upheaval of the timeline a patient may have made.24
Should the Oncologist Offer Treatment for Depression?
Oncologists assume an important role in the medical care of their patients and often initiate or modify treatments for other medical conditions. If a patient develops hypertension or diabetes during or as a direct consequence of treatment, most oncologists feel comfortable starting medication and may then comanage the patient with internists. Primary care physicians and oncologists are typically familiar with a few basic antidepressants, and many are willing to prescribe these for patients who meet the diagnostic criteria for depression, especially since it takes weeks to achieve adequate therapeutic levels for many of these drugs. Recognizing the presence of depression is thus a key diagnostic intervention.
Several efforts have been made to develop self-report screening inventories that can improve the accuracy and efficiency of detection of depressive symptoms and are brief enough to administer in the setting of an office visit. Some tools have been validated and correlate well with more detailed inventories, although the gold standard remains the detailed psychiatric interview.25 A single-item interview screening proposed by Chochinov et al25 years ago performs as well as or better than longer instruments and is remarkably simple to remember. Asking patients “Are you depressed?” in a brief screening interview correctly identified the eventual diagnostic outcome of every patient in initial studies and has been adopted broadly by oncologists and palliative care clinicians caring for patients who are terminally ill.
We support immediate referral to a psychiatrist for any patient who exhibits symptoms of depression, and there is universal agreement that any person who may be suicidal should be referred immediately for urgent psychiatric evaluation. In practice, however, there are two main barriers to successful referrals for those who may be considered to be “managing” and not considered at risk for suicide: Patients are sometimes resistant to or reluctant to accept a recommendation for referral, and the shortage of mental health professionals trained in psycho-oncology limits quick access. It is, therefore, not surprising that cancer clinicians often initiate pharmacologic therapy for depression and provide emotional support to patients and families. Kadan-Lottick and colleagues5 reported that although 90% of patients agreed that they were willing to receive treatment for emotional distress associated with their cancer diagnosis, only 28% accessed treatment. Approximately 55% of the patients diagnosed in that study with major psychiatric disorders did not access treatment. It has been our experience that oncologists are often willing to initiate pharmacologic therapy while the patient is waiting for an appointment with a specialist.
The most frequently prescribed antidepressant medications are the selective serotonin reuptake inhibitors (SSRIs). Frequently, the choice of antidepressant is based on the side-effect profile of a particular medication as there are many effective options, none of which appears to be significantly more efficacious than the others.7 Antidepressants considered to be sedating may not be the preferred option for patients who have significant neurovegetative symptoms including fatigue and low energy. Conversely, antidepressants that cause anorexia and insomnia are poor options for patients experiencing sleepless nights and continued weight loss. Options for more activating antidepressants include sertraline, escitalopram, bupropion, and venlafaxine, while more sedating antidepressant medications include paroxetine and mirtazapine.7 Methylphenidate, a drug frequently used to treat attention-deficit/hyperactivity disorder, has been very effective in patients with low energy and anorexia.[26] and [27] Starting at a low dose in the morning, especially in the elderly, helps to minimize tachycardia and sleeplessness, which can be unwanted side effects of this medication. Lastly, a key point when choosing a medication is the potential for drug–drug interactions. Multiple antidepressants, including paroxetine, fluoxetine, fluvoxamine, and bupropion, interact with the cytochrome P-450 2D6 system, making them more likely to interact with medications commonly used in oncology.28 One example of this potential for interaction occurs with tamoxifen, which is metabolized into its active form, endoxifen, by the cytochrome P-450 2D6 system. It may not be available in adequate concentrations in the setting of antidepressant medications like paroxetine, an inhibitor of cytochrome P-450 2D6. Whether this ultimately influences the efficacy of anticancer treatment is still under investigation.
While psychotherapy is outside the scope of most practicing oncologists, it may be helpful to provide patients with some guidance about the range of available therapies. Individuals may express a clear preference for nonpharmacologic treatments, so it is important for cancer clinicians to familiarize themselves with a few such options. These include cognitive behavioral therapy (CBT), intensive psychotherapy, and group therapy. These interventions can aid patients in reducing anxiety and in strengthening their personal coping mechanisms. Studies to rigorously evaluate the efficacy of these interventions have been challenging to complete because of the lack of a “gold standard” definition of depression in cancer, no consensus on an appropriate length of treatment, no clear way to monitor compliance with a given therapy, and varied definitions of appropriate end points.12 Despite the challenges, several meta-analyses have been compiled to sort through the data. The more commonly referenced meta-analyses have included thousands of patients undergoing nonpharmacologic interventions ranging from individual psychotherapy to group therapy as far back as 1954.[29], [30], [31], [32], [33] and [34] None of the interventions indicate that any particular therapy is more clearly beneficial than another.
CBT has received recent attention and appears to be a good option for many cancer patients with depression. A review by Williams and Dale in the British Journal of Cancer in 200633 outlines 10 studies focusing on the use of CBT in cancer patients with mixed results. Of these, only two found CBT to be ineffective, whereas the rest demonstrated some benefit in reduction of depressive symptoms and improvement in quality of life for patients with a wide assortment of primary malignancies. Most found early improvement in symptoms but not necessarily long-term persistence of the initial positive effects. Group therapy has also been thoroughly studied in depression in cancer patients since Spiegel's landmark study in the late 1980s and has been shown to decrease anxiety, depression, and pain and to increase effective coping.[34], [35], [36], [37], [38] and [39] Many patients report positive experiences in support groups, but others express an intuitive fear that listening to other patients' concerns and negative thoughts will impair their own overall mood and outlook. Not all patients feel comfortable expressing their personal fears, doubts, and frustrations with a group of relative strangers. Any of these concerns is a sufficient reason to advise more personalized attention in a private therapy session with a specialist. Choosing between individual psychotherapy, group, and family therapy can be construed as another aspect of providing truly “personalized” cancer care.
A substantial number of patients worldwide turn to complementary and alternative therapies for the treatment of cancer and cancer-related symptoms.[40], [41] and [42] Estimates of the prevalence of complementary and alternative therapy use vary widely due to differences in definitions and inaccuracies in self-reporting and patient selection. There are emerging data that up to 60%–80% of cancer patients avail themselves of some form of alternative therapy at some point in the trajectory of their disease.42 This number varies widely, likely because the definition of “complementary and alternative therapies” is so broad and can include prayer, use of herbal medications, acupuncture, and meditation. In one study of early-stage breast cancer patients, the use of alternative medicine was significantly associated with patients experiencing depressive symptoms, heightened fear of recurrence, greater physical symptoms, and poor sexual satisfaction.42 At 1 year, all patients, both those using complementary and alternative therapies and those using traditional methods of care, experienced an improvement in quality of life.
For patients who do not meet the criteria for clinical depression and have no interest in or access to support groups, it is worth remembering there are other interventions that can facilitate adjustment and diminish symptoms of anxiety. Expressive writing, music, or art therapy and other activity-based therapies may provide the necessary vehicles for self-expression.
Conclusion
Depression clearly affects patients with cancer, and establishing the depression diagnosis is the first step toward progress in treatment. Despite the challenges, diagnosis is possible by establishing that the symptoms of depression are negatively impacting patients' abilities to cope with their circumstances and maintain balance in their lives. It is critical not only to make the diagnosis of depression but also to strongly encourage patients to seek treatment, either through pharmacologic or nonpharmacologic means. While we make every effort to eradicate our patients' malignancies, we owe it to them to work just as diligently to improve their daily lives by treating associated depression.
References2
1 W.F. Pirl, Evidence report on the occurrence, assessment, and treatment of depression in cancer patients, J Natl Cancer Inst Monogr 32 (2004), pp. 32–39. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (67)
2 J.S. McDaniel, D.L. Musselman, M.R. Porter, D.A. Reed and C.B. Nemeroff, Depression in patients with cancer: diagnosis, biology, and treatment, Arch Gen Psychiatry 52 (1995), pp. 89–99. View Record in Scopus | Cited By in Scopus (339)
3 R.W. Trijsburg, F.C.E. Van Knippenberg and S.E. Rijpma, Effects of psychological treatments on cancer patients: a critical review, Psychosom Med 54 (1992), pp. 489–517. View Record in Scopus | Cited By in Scopus (171)
4 A. Gruneir, T.F. Smith, J. Hirdes and R. Cameron, Depression in patients with advanced illness: an examination of Ontario complex continuing care using the minimum data set 2.0, Palliat Support Care 3 (2005), pp. 99–105. View Record in Scopus | Cited By in Scopus (6)
5 N.S. Kadan-Lottick, L.C. Vanderwerker, S.D. Block, B. Zhang and H.G. Prigerson, Psychiatric disorders and mental health service use in patients with advanced cancer: a report from the Coping with Cancer Study, Cancer 104 (2005), pp. 2872–2881. View Record in Scopus | Cited By in Scopus (57)
6 J.L. Steel, D.A. Geller, T.C. Gamblin, M.C. Olek and B.I. Carr, Depression, immunity, and survival in patients with hepatobiliary carcinoma, J Clin Oncol 25 (2007), pp. 4526–4527.
7 W. Pirl, Depression, anxiety, and fatigue. In: B. Chabner, J. Lynch and D. Longo, Editors, Harrison's Manual of Oncology, McGraw-Hill, New York (2008), pp. 190–196.
8 A. Weissman and J. Worden, The existential plight in cancer: significance of the first 100 days, Psychiatr Med 7 (1976), pp. 1–15.
9 C. Lo, C. Zimmermann and A. Rydall et al., Longitudinal study of depressive symptoms in patients with metastatic gastrointestinal and lung cancer, J Clin Oncol 28 (18) (2010), pp. 3084–3089. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (2)
10 National Comprehensive Cancer Network, NCCN practice guidelines for the management of psychosocial distress, Oncology (Williston Park) 13 (1999), pp. 113–147.
11 National Comprehensive Cancer Network, NCCN clinical practice guidelines in oncology, Distress management (2010) V.1. www.nccn.org.
12 M. Fisch, Treatment of depression in cancer, J Natl Cancer Inst Monogr 32 (2004), pp. 105–111. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (45)
13 H.T. Mermelstein and L. Lesko, Depression in patients with cancer, Psychooncology 1 (1992), pp. 199–215. Full Text via CrossRef
14 American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (4th ed.), American Psychiatric Association, Washington DC (1994).
15 M.L. Chen, C.T. Yu and C.H. Yang, Sleep disturbances and quality of life in lung cancer patients undergoing chemotherapy, Lung Cancer 62 (2008), pp. 391–400. Article |
16 J. Savard, S. Simard and J. Blanchet et al., Prevalence, clinical characteristics, and risk factors for insomnia in the context of breast cancer, Sleep 24 (2001), pp. 583–590. View Record in Scopus | Cited By in Scopus (81)
17 J. Savard and C.M. Morin, Insomnia in the context of cancer: a review of a neglected problem, J Clin Oncol 19 (2001), pp. 895–908. View Record in Scopus | Cited By in Scopus (147)
18 O.G. Palesh, J.A. Roscoe, K.M. Mustian, T. Roth, J. Savard, S. Ancoli-Israel, C. Heckler, J.Q. Purnell, M.C. Janelsins and G.R. Morrow, Prevalence, demographics, and psychological associations of sleep disruption in patients with cancer: University of Rochester Cancer Center–Community Clinical Oncology Program, J Clin Oncol 28 (2010), pp. 292–298. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (7)
19 I. Fras, E.M. Litin and J.S. Pearson, Comparison of psychiatric symptoms in carcinoma of the pancreas with those in some other intraabdominal neoplasms, Am J Psychiatry 123 (1967), pp. 1553–1562. View Record in Scopus | Cited By in Scopus (38)
20 R.T. Joffe, D.R. Rubinow, K.D. Denicoff, M. Maher and W.F. Sindelar, Depression and carcinoma of the pancreas, Gen Hosp Psychiatry 8 (1986), pp. 241–245. Article |
21 R.P. Morton, A.D.M. Davies, J. Baker, G.A. Baker and P.M. Stell, Quality of life in treated head and neck cancer patients: a preliminary report, Clin Otolaryngol 9 (1984), pp. 181–185. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (59)
22 , Micromedex 2.0. DrugPoint summary, interferon alfa-2b http://www.micromedex.com/2 Accessed July 1, 2010.
23 D. Spiegel, A 43-year-old woman coping with cancer, JAMA 281 (4) (1999), pp. 371–377.
24 D.F. Cella, S.M. Mahon and M.I. Donovan, Cancer recurrence as a traumatic event, Behav Med 16 (1990), pp. 15–22. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (126)
25 H.M. Chochinov, K.G. Wilson, M. Enns and S. Lander, “Are you depressed?”: Screening for depression in the terminally ill, Am J Psychiatry 154 (1997), pp. 674–676. View Record in Scopus | Cited By in Scopus (225)
26 E. Bruera, L. Driver and E. Barnes et al., Patient controlled methylphenidate for cancer-related fatigue: a preliminary report, Proc Annu Meet Am Soc Clin Oncol 22 (2003), p. 737.
27 J. Homsi, K.A. Nelson and N. Sarhill et al., A phase II study of methylphenidate for depression in advanced cancer, Am J Hosp Palliat Care 18 (2001), pp. 403–407. View Record in Scopus | Cited By in Scopus (49)
28 G.R. Kalash, Psychotropic drug metabolism in the cancer patient: clinical aspects of management of potential drug interactions, Psychooncology 7 (1998), pp. 307–320. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (4)
29 E.C. Devine and S.K. Westlake, The effects of psychoeducational care provided by adults with cancer: meta-analysis of 116 studies, Oncol Nurs Forum 22 (1995), pp. 1369–1381. View Record in Scopus | Cited By in Scopus (192)
30 T.J. Meyer and M.M. Mark, Effects of psychosocial interventions with adult cancer patients: a meta-analysis of randomized experiments, Health Psychol 14 (1995), pp. 101–108. Abstract |
31 S.A. Newell, R.W. Sanson-Fisher and N.J. Savolainen, Systematic review of psychological therapies for cancer patients: overview and recommendations for the future, J Natl Cancer Inst 94 (2002), pp. 558–584. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (201)
32 T. Sheard and P. Maguire, The effect of psychological interventions on anxiety and depression in cancer patients; results of two meta-analyses, Br J Cancer 80 (1999), pp. 1770–1780. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (210)
33 S. Williams and J. Dale, The effectiveness of treatment for depression/depressive symptoms in adults with cancer: a systematic review, Br J Cancer 94 (2006), pp. 372–390. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (60)
34 D. Spiegel, J.R. Bloom, H.C. Kraemer and E. Gottheil, Effect of psychosocial treatment on survival of patients with metastatic breast cancer, Lancet 2 (1989), pp. 888–891. Article |
35 L.F. Berkman and S.L. Syme, Social networks, host resistence, and mortality: a nine year follow-up study of Alameda County residents, Am J Epidemiol 109 (1979), pp. 186–204. View Record in Scopus | Cited By in Scopus (1297)
36 D.P. Funch and J. Marshall, The role of stress, social support and age in survival from breast cancer, J Psychosom Res 27 (1983), pp. 77–83. Abstract |
37 D.C. Ganster and B. Victor, The impact of social support on mental and physical health, Br J Med Psychol 61 (1988), pp. 17–36. View Record in Scopus | Cited By in Scopus (17)
38 F.I. Fawzy, N. Cousins, N.W. Fawzy, M.E. Kemeny, R. Elashoff and D. Morton, A structured psychiatric intervention for cancer patients: I: Changes over time in methods of coping and affective disturbance, Arch Gen Psychiatry 47 (1990), pp. 720–725. View Record in Scopus | Cited By in Scopus (331)
39 D. Spiegel and J.R. Bloom, Group therapy and hypnosis reduce metastatic breast carcinoma pain, Psychosom Med 45 (1983), pp. 333–339. View Record in Scopus | Cited By in Scopus (192)
40 T. Gansler, C. Kaw, C. Crammer and T. Smith, A population-based study of prevalence of complementary methods use by cancer survivors: a report from the American Cancer Society's studies of cancer survivors, Cancer 113 (2008), pp. 1048–1057. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (13)
41 M.A. Richardson, T. Sanders, J.L. Palmer, A. Greisinger and S.E. Singletary, Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology, J Clin Oncol 18 (13) (2000), pp. 2505–2514. View Record in Scopus | Cited By in Scopus (407)
42 H.J. Burstein, S. Gelber, E. Guadagnoli and J.C. Weeks, Use of alternative medicine by women with early-stage breast cancer, N Engl J Med 340 (22) (1999), pp. 1733–1739. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (352)
How we do it


Article Outline
Data summarized in an excellent review by Pirl published in 2004 show that up to one in five Americans will experience depressive symptoms over the course of their lifetime and that approximately 10%–25% of cancer patients meet criteria for clinical depression.[1] and [2] As our ability to treat depression has improved over the years, thanks in great part to advances in pharmacology and behavioral therapies, it is now critically important to recognize and treat this debilitating disease in individuals with cancer.3 Evidence exists that untreated depression is associated with a worse overall survival for some cancer patients and, paradoxically, that up to half of patients with cancer and concurrent depression are undertreated or receive no treatment.[4], [5] and [6] Medical oncologists receive little or no formal training in psycho-oncology yet are often faced with patients who exhibit changes in mood and become progressively disabled by psychiatric symptoms. Methodical assessment and frequent inquiry may identify patients with cancer and depression.
Peeling Back the Onion: Sorting through Symptoms to Reach a Diagnosis
A diagnosis of cancer often precipitates intense emotions such as fear, sadness, and sometimes anger.2 Individuals who may never have given much thought to their own death are confronted with the very real possibility of a shortened life and future suffering. Roles and relationships shift, careers are interrupted, and daily routines may be sacrificed to make room for cancer treatment. Add to this the financial worries that often accompany a serious illness and it is not surprising that patients may require some level of professional guidance or intervention in order to cope with the crisis. As a quick rule of thumb, it takes about 3–4 weeks after diagnosis to adjust, and during that period it is quite normal for patients to experience intense feelings.7 Weissman and Worden, among the first psychiatrists to study distress in cancer patients, described an acute syndrome of distress over existential plight with the diagnosis and with a recurrence that lasts about 100 days.8 Most individuals, given time and adequate support, will find the inner resources to cope with distressing symptoms and find a new normal. Not all do however, and it is important for oncologists to inquire at regular intervals about how the patient is feeling and coping with illness. A recent study by Lo et al9 found that predictors of depressive symptoms in patients with solid tumors included younger age, antidepressant use at baseline, lower self-esteem and spiritual well-being, greater attachment anxiety, hopelessness, the physical burden of symptoms, and proximity to death.
To facilitate screening for emotional distress in the context of a diagnosis of cancer, the National Comprehensive Cancer Network (NCCN) established guidelines that provide a reproducible algorithm for triaging patients with a suspected depression to mental health professionals.10 These guidelines were updated in 2010 and are widely available.11 The consensus definition of distress in cancer is “a multifactorial, unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment. Distress extends along a continuum, ranging from common feelings of vulnerability, sadness, and fears to problems that can become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.”10 By framing distress as a very broad concept, the guidelines separate the broad gamut of normal emotions from the distinct psychiatric syndromes of anxiety and depression which require specialized professional interventions.12
Distress may be a normal response to a threat or crisis, but depressive symptoms should alert the clinician that something more serious is going on. The appearance of persistent symptoms of dysphoria, hopelessness, helplessness, loss of self-esteem, feelings of worthlessness, and suicidal ideation indicates a psychiatric illness.13 The DSM-IV defines a major depressive episode as experiencing either dysphoria or anhedonia in addition to at least five somatic symptoms for at least 2 weeks.14 These somatic symptoms may well overlap with those experienced by patients as a direct result of their cancer or its treatment. Among these are changes in appetite, weight, or sleep; fatigue; loss of energy; and a diminished ability to think or concentrate. The challenge for clinicians is to tease apart the physiologic consequences of disease and side effects of medications from those due to profound and disabling psychiatric syndromes.
Many symptoms caused by cancer itself can be confused with neurovegetative symptoms of depression. Pain is known to modulate the reporting of symptoms; fatigue and weight changes are often secondary to cancer treatment or the illness itself. Patients often feel fatigued due to the heightened metabolic state present when there is a high burden of disease, and cytokines elevated in malignancy have been shown to cause fatigue and appetite suppression. There is a growing literature regarding the development of aberrant sleep patterns in patients with cancer, which can be mistaken for depressive daytime somnolence or insomnia.[15], [16], [17] and [18] Some cancers themselves are associated with a higher risk of depressive symptoms, including pancreatic cancer and cancers of the head and neck.[19], [20] and [21] Chemotherapy can also induce fatigue, insomnia, and anhedonia, as can the steroids often used concomitantly with chemotherapeutic or biologic agents. Interferon-alpha, used to treat melanoma and renal cell cancer, has been associated with depression in 3%–40% of patients; and there is a 5% rate of suicidal thoughts.22
Cancer patients exhibit a range of coping styles and varying degrees of emotional resiliency. If a patient is able to process his or her emotional responses to the physical threat of a diagnosis and becomes mobilized in such a way that he or she obtains useful information and is able to prioritize concerns, obtain social support, and move toward a coherent treatment plan, one can easily assume that he or she is coping well.23 On the other hand, if the patient appears unable to make a decision about treatment, avoids addressing or discussing important issues, and retreats from family, friends, and/or the medical team, one can infer that he or she is having trouble coping and could benefit from a referral to a mental health professional for evaluation.23 Known risk factors for poor coping and for developing depression include social isolation, use of few coping strategies, a history of recent losses or multiple obligations, inflexible coping strategies, the presence of pain, and socioeconomic pressures.[8] and [23] In extreme cases, patients may resort to deferring decisions or simply denying the problem.
Keep in mind there may also be cultural or personal barriers that interfere with a timely and accurate diagnosis of depression.12 Many families believe strongly in the “power of positive thinking” and need to feel that their family member is a “fighter.” This type of encouragement may at times be helpful for a patient, but it may not leave a safe opening for the expression of fear, pain, or depressed mood. If the matriarch or patriarch of the family has supported everyone else through the difficulties in their lives, she or he may not feel able to show weakness and seek help for depression. This can be a difficult patient to diagnose as the only clue to suffering may be easy to miss. In fact, if there are very few questions or complaints when there is clear physical suffering, one needs to worry that the patient is unable to express his or her deep concerns. The clinician who spots this situation early on may be able to lead the patient in the direction of expressing his or her feelings by suggesting that others in similar situations also experience stress or sadness. Finding a private time to talk, away from family members, may also provide a more comfortable environment for a candid conversation.
If we think of the disease trajectory as a marathon, then we can learn to recognize certain landmarks along the course and remember that these pose enormous challenges to patients. In addition to receiving the initial diagnosis, the period of active treatment, the conclusion of active treatment, and the time of disease recurrence pose specific challenges and precipitate intense emotions. Disease recurrence is a time of great anxiety when there is a need to plan for future treatment and an upheaval of the timeline a patient may have made.24
Should the Oncologist Offer Treatment for Depression?
Oncologists assume an important role in the medical care of their patients and often initiate or modify treatments for other medical conditions. If a patient develops hypertension or diabetes during or as a direct consequence of treatment, most oncologists feel comfortable starting medication and may then comanage the patient with internists. Primary care physicians and oncologists are typically familiar with a few basic antidepressants, and many are willing to prescribe these for patients who meet the diagnostic criteria for depression, especially since it takes weeks to achieve adequate therapeutic levels for many of these drugs. Recognizing the presence of depression is thus a key diagnostic intervention.
Several efforts have been made to develop self-report screening inventories that can improve the accuracy and efficiency of detection of depressive symptoms and are brief enough to administer in the setting of an office visit. Some tools have been validated and correlate well with more detailed inventories, although the gold standard remains the detailed psychiatric interview.25 A single-item interview screening proposed by Chochinov et al25 years ago performs as well as or better than longer instruments and is remarkably simple to remember. Asking patients “Are you depressed?” in a brief screening interview correctly identified the eventual diagnostic outcome of every patient in initial studies and has been adopted broadly by oncologists and palliative care clinicians caring for patients who are terminally ill.
We support immediate referral to a psychiatrist for any patient who exhibits symptoms of depression, and there is universal agreement that any person who may be suicidal should be referred immediately for urgent psychiatric evaluation. In practice, however, there are two main barriers to successful referrals for those who may be considered to be “managing” and not considered at risk for suicide: Patients are sometimes resistant to or reluctant to accept a recommendation for referral, and the shortage of mental health professionals trained in psycho-oncology limits quick access. It is, therefore, not surprising that cancer clinicians often initiate pharmacologic therapy for depression and provide emotional support to patients and families. Kadan-Lottick and colleagues5 reported that although 90% of patients agreed that they were willing to receive treatment for emotional distress associated with their cancer diagnosis, only 28% accessed treatment. Approximately 55% of the patients diagnosed in that study with major psychiatric disorders did not access treatment. It has been our experience that oncologists are often willing to initiate pharmacologic therapy while the patient is waiting for an appointment with a specialist.
The most frequently prescribed antidepressant medications are the selective serotonin reuptake inhibitors (SSRIs). Frequently, the choice of antidepressant is based on the side-effect profile of a particular medication as there are many effective options, none of which appears to be significantly more efficacious than the others.7 Antidepressants considered to be sedating may not be the preferred option for patients who have significant neurovegetative symptoms including fatigue and low energy. Conversely, antidepressants that cause anorexia and insomnia are poor options for patients experiencing sleepless nights and continued weight loss. Options for more activating antidepressants include sertraline, escitalopram, bupropion, and venlafaxine, while more sedating antidepressant medications include paroxetine and mirtazapine.7 Methylphenidate, a drug frequently used to treat attention-deficit/hyperactivity disorder, has been very effective in patients with low energy and anorexia.[26] and [27] Starting at a low dose in the morning, especially in the elderly, helps to minimize tachycardia and sleeplessness, which can be unwanted side effects of this medication. Lastly, a key point when choosing a medication is the potential for drug–drug interactions. Multiple antidepressants, including paroxetine, fluoxetine, fluvoxamine, and bupropion, interact with the cytochrome P-450 2D6 system, making them more likely to interact with medications commonly used in oncology.28 One example of this potential for interaction occurs with tamoxifen, which is metabolized into its active form, endoxifen, by the cytochrome P-450 2D6 system. It may not be available in adequate concentrations in the setting of antidepressant medications like paroxetine, an inhibitor of cytochrome P-450 2D6. Whether this ultimately influences the efficacy of anticancer treatment is still under investigation.
While psychotherapy is outside the scope of most practicing oncologists, it may be helpful to provide patients with some guidance about the range of available therapies. Individuals may express a clear preference for nonpharmacologic treatments, so it is important for cancer clinicians to familiarize themselves with a few such options. These include cognitive behavioral therapy (CBT), intensive psychotherapy, and group therapy. These interventions can aid patients in reducing anxiety and in strengthening their personal coping mechanisms. Studies to rigorously evaluate the efficacy of these interventions have been challenging to complete because of the lack of a “gold standard” definition of depression in cancer, no consensus on an appropriate length of treatment, no clear way to monitor compliance with a given therapy, and varied definitions of appropriate end points.12 Despite the challenges, several meta-analyses have been compiled to sort through the data. The more commonly referenced meta-analyses have included thousands of patients undergoing nonpharmacologic interventions ranging from individual psychotherapy to group therapy as far back as 1954.[29], [30], [31], [32], [33] and [34] None of the interventions indicate that any particular therapy is more clearly beneficial than another.
CBT has received recent attention and appears to be a good option for many cancer patients with depression. A review by Williams and Dale in the British Journal of Cancer in 200633 outlines 10 studies focusing on the use of CBT in cancer patients with mixed results. Of these, only two found CBT to be ineffective, whereas the rest demonstrated some benefit in reduction of depressive symptoms and improvement in quality of life for patients with a wide assortment of primary malignancies. Most found early improvement in symptoms but not necessarily long-term persistence of the initial positive effects. Group therapy has also been thoroughly studied in depression in cancer patients since Spiegel's landmark study in the late 1980s and has been shown to decrease anxiety, depression, and pain and to increase effective coping.[34], [35], [36], [37], [38] and [39] Many patients report positive experiences in support groups, but others express an intuitive fear that listening to other patients' concerns and negative thoughts will impair their own overall mood and outlook. Not all patients feel comfortable expressing their personal fears, doubts, and frustrations with a group of relative strangers. Any of these concerns is a sufficient reason to advise more personalized attention in a private therapy session with a specialist. Choosing between individual psychotherapy, group, and family therapy can be construed as another aspect of providing truly “personalized” cancer care.
A substantial number of patients worldwide turn to complementary and alternative therapies for the treatment of cancer and cancer-related symptoms.[40], [41] and [42] Estimates of the prevalence of complementary and alternative therapy use vary widely due to differences in definitions and inaccuracies in self-reporting and patient selection. There are emerging data that up to 60%–80% of cancer patients avail themselves of some form of alternative therapy at some point in the trajectory of their disease.42 This number varies widely, likely because the definition of “complementary and alternative therapies” is so broad and can include prayer, use of herbal medications, acupuncture, and meditation. In one study of early-stage breast cancer patients, the use of alternative medicine was significantly associated with patients experiencing depressive symptoms, heightened fear of recurrence, greater physical symptoms, and poor sexual satisfaction.42 At 1 year, all patients, both those using complementary and alternative therapies and those using traditional methods of care, experienced an improvement in quality of life.
For patients who do not meet the criteria for clinical depression and have no interest in or access to support groups, it is worth remembering there are other interventions that can facilitate adjustment and diminish symptoms of anxiety. Expressive writing, music, or art therapy and other activity-based therapies may provide the necessary vehicles for self-expression.
Conclusion
Depression clearly affects patients with cancer, and establishing the depression diagnosis is the first step toward progress in treatment. Despite the challenges, diagnosis is possible by establishing that the symptoms of depression are negatively impacting patients' abilities to cope with their circumstances and maintain balance in their lives. It is critical not only to make the diagnosis of depression but also to strongly encourage patients to seek treatment, either through pharmacologic or nonpharmacologic means. While we make every effort to eradicate our patients' malignancies, we owe it to them to work just as diligently to improve their daily lives by treating associated depression.
References2
1 W.F. Pirl, Evidence report on the occurrence, assessment, and treatment of depression in cancer patients, J Natl Cancer Inst Monogr 32 (2004), pp. 32–39. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (67)
2 J.S. McDaniel, D.L. Musselman, M.R. Porter, D.A. Reed and C.B. Nemeroff, Depression in patients with cancer: diagnosis, biology, and treatment, Arch Gen Psychiatry 52 (1995), pp. 89–99. View Record in Scopus | Cited By in Scopus (339)
3 R.W. Trijsburg, F.C.E. Van Knippenberg and S.E. Rijpma, Effects of psychological treatments on cancer patients: a critical review, Psychosom Med 54 (1992), pp. 489–517. View Record in Scopus | Cited By in Scopus (171)
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5 N.S. Kadan-Lottick, L.C. Vanderwerker, S.D. Block, B. Zhang and H.G. Prigerson, Psychiatric disorders and mental health service use in patients with advanced cancer: a report from the Coping with Cancer Study, Cancer 104 (2005), pp. 2872–2881. View Record in Scopus | Cited By in Scopus (57)
6 J.L. Steel, D.A. Geller, T.C. Gamblin, M.C. Olek and B.I. Carr, Depression, immunity, and survival in patients with hepatobiliary carcinoma, J Clin Oncol 25 (2007), pp. 4526–4527.
7 W. Pirl, Depression, anxiety, and fatigue. In: B. Chabner, J. Lynch and D. Longo, Editors, Harrison's Manual of Oncology, McGraw-Hill, New York (2008), pp. 190–196.
8 A. Weissman and J. Worden, The existential plight in cancer: significance of the first 100 days, Psychiatr Med 7 (1976), pp. 1–15.
9 C. Lo, C. Zimmermann and A. Rydall et al., Longitudinal study of depressive symptoms in patients with metastatic gastrointestinal and lung cancer, J Clin Oncol 28 (18) (2010), pp. 3084–3089. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (2)
10 National Comprehensive Cancer Network, NCCN practice guidelines for the management of psychosocial distress, Oncology (Williston Park) 13 (1999), pp. 113–147.
11 National Comprehensive Cancer Network, NCCN clinical practice guidelines in oncology, Distress management (2010) V.1. www.nccn.org.
12 M. Fisch, Treatment of depression in cancer, J Natl Cancer Inst Monogr 32 (2004), pp. 105–111. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (45)
13 H.T. Mermelstein and L. Lesko, Depression in patients with cancer, Psychooncology 1 (1992), pp. 199–215. Full Text via CrossRef
14 American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (4th ed.), American Psychiatric Association, Washington DC (1994).
15 M.L. Chen, C.T. Yu and C.H. Yang, Sleep disturbances and quality of life in lung cancer patients undergoing chemotherapy, Lung Cancer 62 (2008), pp. 391–400. Article |
16 J. Savard, S. Simard and J. Blanchet et al., Prevalence, clinical characteristics, and risk factors for insomnia in the context of breast cancer, Sleep 24 (2001), pp. 583–590. View Record in Scopus | Cited By in Scopus (81)
17 J. Savard and C.M. Morin, Insomnia in the context of cancer: a review of a neglected problem, J Clin Oncol 19 (2001), pp. 895–908. View Record in Scopus | Cited By in Scopus (147)
18 O.G. Palesh, J.A. Roscoe, K.M. Mustian, T. Roth, J. Savard, S. Ancoli-Israel, C. Heckler, J.Q. Purnell, M.C. Janelsins and G.R. Morrow, Prevalence, demographics, and psychological associations of sleep disruption in patients with cancer: University of Rochester Cancer Center–Community Clinical Oncology Program, J Clin Oncol 28 (2010), pp. 292–298. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (7)
19 I. Fras, E.M. Litin and J.S. Pearson, Comparison of psychiatric symptoms in carcinoma of the pancreas with those in some other intraabdominal neoplasms, Am J Psychiatry 123 (1967), pp. 1553–1562. View Record in Scopus | Cited By in Scopus (38)
20 R.T. Joffe, D.R. Rubinow, K.D. Denicoff, M. Maher and W.F. Sindelar, Depression and carcinoma of the pancreas, Gen Hosp Psychiatry 8 (1986), pp. 241–245. Article |
21 R.P. Morton, A.D.M. Davies, J. Baker, G.A. Baker and P.M. Stell, Quality of life in treated head and neck cancer patients: a preliminary report, Clin Otolaryngol 9 (1984), pp. 181–185. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (59)
22 , Micromedex 2.0. DrugPoint summary, interferon alfa-2b http://www.micromedex.com/2 Accessed July 1, 2010.
23 D. Spiegel, A 43-year-old woman coping with cancer, JAMA 281 (4) (1999), pp. 371–377.
24 D.F. Cella, S.M. Mahon and M.I. Donovan, Cancer recurrence as a traumatic event, Behav Med 16 (1990), pp. 15–22. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (126)
25 H.M. Chochinov, K.G. Wilson, M. Enns and S. Lander, “Are you depressed?”: Screening for depression in the terminally ill, Am J Psychiatry 154 (1997), pp. 674–676. View Record in Scopus | Cited By in Scopus (225)
26 E. Bruera, L. Driver and E. Barnes et al., Patient controlled methylphenidate for cancer-related fatigue: a preliminary report, Proc Annu Meet Am Soc Clin Oncol 22 (2003), p. 737.
27 J. Homsi, K.A. Nelson and N. Sarhill et al., A phase II study of methylphenidate for depression in advanced cancer, Am J Hosp Palliat Care 18 (2001), pp. 403–407. View Record in Scopus | Cited By in Scopus (49)
28 G.R. Kalash, Psychotropic drug metabolism in the cancer patient: clinical aspects of management of potential drug interactions, Psychooncology 7 (1998), pp. 307–320. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (4)
29 E.C. Devine and S.K. Westlake, The effects of psychoeducational care provided by adults with cancer: meta-analysis of 116 studies, Oncol Nurs Forum 22 (1995), pp. 1369–1381. View Record in Scopus | Cited By in Scopus (192)
30 T.J. Meyer and M.M. Mark, Effects of psychosocial interventions with adult cancer patients: a meta-analysis of randomized experiments, Health Psychol 14 (1995), pp. 101–108. Abstract |
31 S.A. Newell, R.W. Sanson-Fisher and N.J. Savolainen, Systematic review of psychological therapies for cancer patients: overview and recommendations for the future, J Natl Cancer Inst 94 (2002), pp. 558–584. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (201)
32 T. Sheard and P. Maguire, The effect of psychological interventions on anxiety and depression in cancer patients; results of two meta-analyses, Br J Cancer 80 (1999), pp. 1770–1780. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (210)
33 S. Williams and J. Dale, The effectiveness of treatment for depression/depressive symptoms in adults with cancer: a systematic review, Br J Cancer 94 (2006), pp. 372–390. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (60)
34 D. Spiegel, J.R. Bloom, H.C. Kraemer and E. Gottheil, Effect of psychosocial treatment on survival of patients with metastatic breast cancer, Lancet 2 (1989), pp. 888–891. Article |
35 L.F. Berkman and S.L. Syme, Social networks, host resistence, and mortality: a nine year follow-up study of Alameda County residents, Am J Epidemiol 109 (1979), pp. 186–204. View Record in Scopus | Cited By in Scopus (1297)
36 D.P. Funch and J. Marshall, The role of stress, social support and age in survival from breast cancer, J Psychosom Res 27 (1983), pp. 77–83. Abstract |
37 D.C. Ganster and B. Victor, The impact of social support on mental and physical health, Br J Med Psychol 61 (1988), pp. 17–36. View Record in Scopus | Cited By in Scopus (17)
38 F.I. Fawzy, N. Cousins, N.W. Fawzy, M.E. Kemeny, R. Elashoff and D. Morton, A structured psychiatric intervention for cancer patients: I: Changes over time in methods of coping and affective disturbance, Arch Gen Psychiatry 47 (1990), pp. 720–725. View Record in Scopus | Cited By in Scopus (331)
39 D. Spiegel and J.R. Bloom, Group therapy and hypnosis reduce metastatic breast carcinoma pain, Psychosom Med 45 (1983), pp. 333–339. View Record in Scopus | Cited By in Scopus (192)
40 T. Gansler, C. Kaw, C. Crammer and T. Smith, A population-based study of prevalence of complementary methods use by cancer survivors: a report from the American Cancer Society's studies of cancer survivors, Cancer 113 (2008), pp. 1048–1057. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (13)
41 M.A. Richardson, T. Sanders, J.L. Palmer, A. Greisinger and S.E. Singletary, Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology, J Clin Oncol 18 (13) (2000), pp. 2505–2514. View Record in Scopus | Cited By in Scopus (407)
42 H.J. Burstein, S. Gelber, E. Guadagnoli and J.C. Weeks, Use of alternative medicine by women with early-stage breast cancer, N Engl J Med 340 (22) (1999), pp. 1733–1739. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (352)
How we do it


Article Outline
Data summarized in an excellent review by Pirl published in 2004 show that up to one in five Americans will experience depressive symptoms over the course of their lifetime and that approximately 10%–25% of cancer patients meet criteria for clinical depression.[1] and [2] As our ability to treat depression has improved over the years, thanks in great part to advances in pharmacology and behavioral therapies, it is now critically important to recognize and treat this debilitating disease in individuals with cancer.3 Evidence exists that untreated depression is associated with a worse overall survival for some cancer patients and, paradoxically, that up to half of patients with cancer and concurrent depression are undertreated or receive no treatment.[4], [5] and [6] Medical oncologists receive little or no formal training in psycho-oncology yet are often faced with patients who exhibit changes in mood and become progressively disabled by psychiatric symptoms. Methodical assessment and frequent inquiry may identify patients with cancer and depression.
Peeling Back the Onion: Sorting through Symptoms to Reach a Diagnosis
A diagnosis of cancer often precipitates intense emotions such as fear, sadness, and sometimes anger.2 Individuals who may never have given much thought to their own death are confronted with the very real possibility of a shortened life and future suffering. Roles and relationships shift, careers are interrupted, and daily routines may be sacrificed to make room for cancer treatment. Add to this the financial worries that often accompany a serious illness and it is not surprising that patients may require some level of professional guidance or intervention in order to cope with the crisis. As a quick rule of thumb, it takes about 3–4 weeks after diagnosis to adjust, and during that period it is quite normal for patients to experience intense feelings.7 Weissman and Worden, among the first psychiatrists to study distress in cancer patients, described an acute syndrome of distress over existential plight with the diagnosis and with a recurrence that lasts about 100 days.8 Most individuals, given time and adequate support, will find the inner resources to cope with distressing symptoms and find a new normal. Not all do however, and it is important for oncologists to inquire at regular intervals about how the patient is feeling and coping with illness. A recent study by Lo et al9 found that predictors of depressive symptoms in patients with solid tumors included younger age, antidepressant use at baseline, lower self-esteem and spiritual well-being, greater attachment anxiety, hopelessness, the physical burden of symptoms, and proximity to death.
To facilitate screening for emotional distress in the context of a diagnosis of cancer, the National Comprehensive Cancer Network (NCCN) established guidelines that provide a reproducible algorithm for triaging patients with a suspected depression to mental health professionals.10 These guidelines were updated in 2010 and are widely available.11 The consensus definition of distress in cancer is “a multifactorial, unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment. Distress extends along a continuum, ranging from common feelings of vulnerability, sadness, and fears to problems that can become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.”10 By framing distress as a very broad concept, the guidelines separate the broad gamut of normal emotions from the distinct psychiatric syndromes of anxiety and depression which require specialized professional interventions.12
Distress may be a normal response to a threat or crisis, but depressive symptoms should alert the clinician that something more serious is going on. The appearance of persistent symptoms of dysphoria, hopelessness, helplessness, loss of self-esteem, feelings of worthlessness, and suicidal ideation indicates a psychiatric illness.13 The DSM-IV defines a major depressive episode as experiencing either dysphoria or anhedonia in addition to at least five somatic symptoms for at least 2 weeks.14 These somatic symptoms may well overlap with those experienced by patients as a direct result of their cancer or its treatment. Among these are changes in appetite, weight, or sleep; fatigue; loss of energy; and a diminished ability to think or concentrate. The challenge for clinicians is to tease apart the physiologic consequences of disease and side effects of medications from those due to profound and disabling psychiatric syndromes.
Many symptoms caused by cancer itself can be confused with neurovegetative symptoms of depression. Pain is known to modulate the reporting of symptoms; fatigue and weight changes are often secondary to cancer treatment or the illness itself. Patients often feel fatigued due to the heightened metabolic state present when there is a high burden of disease, and cytokines elevated in malignancy have been shown to cause fatigue and appetite suppression. There is a growing literature regarding the development of aberrant sleep patterns in patients with cancer, which can be mistaken for depressive daytime somnolence or insomnia.[15], [16], [17] and [18] Some cancers themselves are associated with a higher risk of depressive symptoms, including pancreatic cancer and cancers of the head and neck.[19], [20] and [21] Chemotherapy can also induce fatigue, insomnia, and anhedonia, as can the steroids often used concomitantly with chemotherapeutic or biologic agents. Interferon-alpha, used to treat melanoma and renal cell cancer, has been associated with depression in 3%–40% of patients; and there is a 5% rate of suicidal thoughts.22
Cancer patients exhibit a range of coping styles and varying degrees of emotional resiliency. If a patient is able to process his or her emotional responses to the physical threat of a diagnosis and becomes mobilized in such a way that he or she obtains useful information and is able to prioritize concerns, obtain social support, and move toward a coherent treatment plan, one can easily assume that he or she is coping well.23 On the other hand, if the patient appears unable to make a decision about treatment, avoids addressing or discussing important issues, and retreats from family, friends, and/or the medical team, one can infer that he or she is having trouble coping and could benefit from a referral to a mental health professional for evaluation.23 Known risk factors for poor coping and for developing depression include social isolation, use of few coping strategies, a history of recent losses or multiple obligations, inflexible coping strategies, the presence of pain, and socioeconomic pressures.[8] and [23] In extreme cases, patients may resort to deferring decisions or simply denying the problem.
Keep in mind there may also be cultural or personal barriers that interfere with a timely and accurate diagnosis of depression.12 Many families believe strongly in the “power of positive thinking” and need to feel that their family member is a “fighter.” This type of encouragement may at times be helpful for a patient, but it may not leave a safe opening for the expression of fear, pain, or depressed mood. If the matriarch or patriarch of the family has supported everyone else through the difficulties in their lives, she or he may not feel able to show weakness and seek help for depression. This can be a difficult patient to diagnose as the only clue to suffering may be easy to miss. In fact, if there are very few questions or complaints when there is clear physical suffering, one needs to worry that the patient is unable to express his or her deep concerns. The clinician who spots this situation early on may be able to lead the patient in the direction of expressing his or her feelings by suggesting that others in similar situations also experience stress or sadness. Finding a private time to talk, away from family members, may also provide a more comfortable environment for a candid conversation.
If we think of the disease trajectory as a marathon, then we can learn to recognize certain landmarks along the course and remember that these pose enormous challenges to patients. In addition to receiving the initial diagnosis, the period of active treatment, the conclusion of active treatment, and the time of disease recurrence pose specific challenges and precipitate intense emotions. Disease recurrence is a time of great anxiety when there is a need to plan for future treatment and an upheaval of the timeline a patient may have made.24
Should the Oncologist Offer Treatment for Depression?
Oncologists assume an important role in the medical care of their patients and often initiate or modify treatments for other medical conditions. If a patient develops hypertension or diabetes during or as a direct consequence of treatment, most oncologists feel comfortable starting medication and may then comanage the patient with internists. Primary care physicians and oncologists are typically familiar with a few basic antidepressants, and many are willing to prescribe these for patients who meet the diagnostic criteria for depression, especially since it takes weeks to achieve adequate therapeutic levels for many of these drugs. Recognizing the presence of depression is thus a key diagnostic intervention.
Several efforts have been made to develop self-report screening inventories that can improve the accuracy and efficiency of detection of depressive symptoms and are brief enough to administer in the setting of an office visit. Some tools have been validated and correlate well with more detailed inventories, although the gold standard remains the detailed psychiatric interview.25 A single-item interview screening proposed by Chochinov et al25 years ago performs as well as or better than longer instruments and is remarkably simple to remember. Asking patients “Are you depressed?” in a brief screening interview correctly identified the eventual diagnostic outcome of every patient in initial studies and has been adopted broadly by oncologists and palliative care clinicians caring for patients who are terminally ill.
We support immediate referral to a psychiatrist for any patient who exhibits symptoms of depression, and there is universal agreement that any person who may be suicidal should be referred immediately for urgent psychiatric evaluation. In practice, however, there are two main barriers to successful referrals for those who may be considered to be “managing” and not considered at risk for suicide: Patients are sometimes resistant to or reluctant to accept a recommendation for referral, and the shortage of mental health professionals trained in psycho-oncology limits quick access. It is, therefore, not surprising that cancer clinicians often initiate pharmacologic therapy for depression and provide emotional support to patients and families. Kadan-Lottick and colleagues5 reported that although 90% of patients agreed that they were willing to receive treatment for emotional distress associated with their cancer diagnosis, only 28% accessed treatment. Approximately 55% of the patients diagnosed in that study with major psychiatric disorders did not access treatment. It has been our experience that oncologists are often willing to initiate pharmacologic therapy while the patient is waiting for an appointment with a specialist.
The most frequently prescribed antidepressant medications are the selective serotonin reuptake inhibitors (SSRIs). Frequently, the choice of antidepressant is based on the side-effect profile of a particular medication as there are many effective options, none of which appears to be significantly more efficacious than the others.7 Antidepressants considered to be sedating may not be the preferred option for patients who have significant neurovegetative symptoms including fatigue and low energy. Conversely, antidepressants that cause anorexia and insomnia are poor options for patients experiencing sleepless nights and continued weight loss. Options for more activating antidepressants include sertraline, escitalopram, bupropion, and venlafaxine, while more sedating antidepressant medications include paroxetine and mirtazapine.7 Methylphenidate, a drug frequently used to treat attention-deficit/hyperactivity disorder, has been very effective in patients with low energy and anorexia.[26] and [27] Starting at a low dose in the morning, especially in the elderly, helps to minimize tachycardia and sleeplessness, which can be unwanted side effects of this medication. Lastly, a key point when choosing a medication is the potential for drug–drug interactions. Multiple antidepressants, including paroxetine, fluoxetine, fluvoxamine, and bupropion, interact with the cytochrome P-450 2D6 system, making them more likely to interact with medications commonly used in oncology.28 One example of this potential for interaction occurs with tamoxifen, which is metabolized into its active form, endoxifen, by the cytochrome P-450 2D6 system. It may not be available in adequate concentrations in the setting of antidepressant medications like paroxetine, an inhibitor of cytochrome P-450 2D6. Whether this ultimately influences the efficacy of anticancer treatment is still under investigation.
While psychotherapy is outside the scope of most practicing oncologists, it may be helpful to provide patients with some guidance about the range of available therapies. Individuals may express a clear preference for nonpharmacologic treatments, so it is important for cancer clinicians to familiarize themselves with a few such options. These include cognitive behavioral therapy (CBT), intensive psychotherapy, and group therapy. These interventions can aid patients in reducing anxiety and in strengthening their personal coping mechanisms. Studies to rigorously evaluate the efficacy of these interventions have been challenging to complete because of the lack of a “gold standard” definition of depression in cancer, no consensus on an appropriate length of treatment, no clear way to monitor compliance with a given therapy, and varied definitions of appropriate end points.12 Despite the challenges, several meta-analyses have been compiled to sort through the data. The more commonly referenced meta-analyses have included thousands of patients undergoing nonpharmacologic interventions ranging from individual psychotherapy to group therapy as far back as 1954.[29], [30], [31], [32], [33] and [34] None of the interventions indicate that any particular therapy is more clearly beneficial than another.
CBT has received recent attention and appears to be a good option for many cancer patients with depression. A review by Williams and Dale in the British Journal of Cancer in 200633 outlines 10 studies focusing on the use of CBT in cancer patients with mixed results. Of these, only two found CBT to be ineffective, whereas the rest demonstrated some benefit in reduction of depressive symptoms and improvement in quality of life for patients with a wide assortment of primary malignancies. Most found early improvement in symptoms but not necessarily long-term persistence of the initial positive effects. Group therapy has also been thoroughly studied in depression in cancer patients since Spiegel's landmark study in the late 1980s and has been shown to decrease anxiety, depression, and pain and to increase effective coping.[34], [35], [36], [37], [38] and [39] Many patients report positive experiences in support groups, but others express an intuitive fear that listening to other patients' concerns and negative thoughts will impair their own overall mood and outlook. Not all patients feel comfortable expressing their personal fears, doubts, and frustrations with a group of relative strangers. Any of these concerns is a sufficient reason to advise more personalized attention in a private therapy session with a specialist. Choosing between individual psychotherapy, group, and family therapy can be construed as another aspect of providing truly “personalized” cancer care.
A substantial number of patients worldwide turn to complementary and alternative therapies for the treatment of cancer and cancer-related symptoms.[40], [41] and [42] Estimates of the prevalence of complementary and alternative therapy use vary widely due to differences in definitions and inaccuracies in self-reporting and patient selection. There are emerging data that up to 60%–80% of cancer patients avail themselves of some form of alternative therapy at some point in the trajectory of their disease.42 This number varies widely, likely because the definition of “complementary and alternative therapies” is so broad and can include prayer, use of herbal medications, acupuncture, and meditation. In one study of early-stage breast cancer patients, the use of alternative medicine was significantly associated with patients experiencing depressive symptoms, heightened fear of recurrence, greater physical symptoms, and poor sexual satisfaction.42 At 1 year, all patients, both those using complementary and alternative therapies and those using traditional methods of care, experienced an improvement in quality of life.
For patients who do not meet the criteria for clinical depression and have no interest in or access to support groups, it is worth remembering there are other interventions that can facilitate adjustment and diminish symptoms of anxiety. Expressive writing, music, or art therapy and other activity-based therapies may provide the necessary vehicles for self-expression.
Conclusion
Depression clearly affects patients with cancer, and establishing the depression diagnosis is the first step toward progress in treatment. Despite the challenges, diagnosis is possible by establishing that the symptoms of depression are negatively impacting patients' abilities to cope with their circumstances and maintain balance in their lives. It is critical not only to make the diagnosis of depression but also to strongly encourage patients to seek treatment, either through pharmacologic or nonpharmacologic means. While we make every effort to eradicate our patients' malignancies, we owe it to them to work just as diligently to improve their daily lives by treating associated depression.
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38 F.I. Fawzy, N. Cousins, N.W. Fawzy, M.E. Kemeny, R. Elashoff and D. Morton, A structured psychiatric intervention for cancer patients: I: Changes over time in methods of coping and affective disturbance, Arch Gen Psychiatry 47 (1990), pp. 720–725. View Record in Scopus | Cited By in Scopus (331)
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41 M.A. Richardson, T. Sanders, J.L. Palmer, A. Greisinger and S.E. Singletary, Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology, J Clin Oncol 18 (13) (2000), pp. 2505–2514. View Record in Scopus | Cited By in Scopus (407)
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The Comanagement Conundrum
As patient care grows ever more complex, driven by demographic shifts and regulatory trends, hospitalists around the country continue to worry about the “dumping” practices of referring surgeons and other specialists. Negative nicknames like “admitologist,” “dischargologist,” or “glorified resident” reflect the concerns of some veteran physicians who find themselves doing what they perceive as “scut work”—merely processing the surgeons’ patients through the hospitalization.
Comanagement has been proposed as a solution to improve both patient care and professional satisfaction. But its promise can be eroded if the arrangement isn’t well planned and executed, experts say. Comanagement requires clearly defined roles, collaborative professional relationships, and some sense of equal standing with the surgeons or other specialists who call on hospitalists to care for their hospitalized patients’ medical needs.
“The growing formalization of comanagement agreements stems from prior tendency by some to view hospitalists as glorified house staff,” says Christopher Whinney, MD, FACP, FHM, director of comanagement at The Cleveland Clinic. “Hospitalists feel this is inappropriate, based on our skill set and scope of practice. There is also a concern that if a hospitalist group jumps in to do this without a clear service agreement in writing, that is where dumping can become a problem.”
Dr. Whinney is one of two expert mentors for hospitalists under a new SHM demonstration project called the Hospitalist Orthopedic Patient Service Comanagement Program, which is gathering data to evaluate its effectiveness on clinical and other outcomes. He has been working with five of the 10 participating HM groups, helping them define what it means to institutionalize formal comanagement relationships.
“Whatever your personal feelings about the comanagement relationship, pro or con, comanagement is going to be part of most hospital medicine groups’ repertoire of services,” says Hugo Quinny Cheng, MD, director of the comanagement with neurosurgery service at the University of California at San Francisco (UCSF) Medical Center. “You can try to avoid it, but if the medical center and the surgeons want it, there’s going to be pressure on your group to do it—or else they’ll look for another hospitalist group to do it.”
Dr. Cheng advises hospitalist group leaders make themselves aware of the trend and position themselves in a way to take advantage of it—or, at the very least, not be blindsided by it.
According to SHM data, 85% of hospitalist groups have done some kind of comanagement.1 It’s not explicitly listed by SHM as one of The Core Competencies in Hospital Medicine, but it might as well be, says Leslie Flores, MHA, SHM senior advisor, practice management, because aspects of comanagement are addressed throughout.2
Defined, Distinguished, Delineated
Comanagement is different from traditional medical consultations performed by hospitalists upon request, and also differs from cases in which the hospitalist is the admitting physician of record with sole management responsibilities while the patient is in the hospital. According to an SHM white paper, A Guide to Hospitalist/Orthopedic Surgery Comanagement, the concept involves shared responsibility, authority, and accountability for the care of hospitalized patients, typically with orthopedic surgeons or other specialties, and with the hospitalist managing the patient’s medical concerns, such as diabetes, congestive heart failure, or DVT.3 (SHM’s website is full of comanagement resources, including sample service agreements; visit www.hospitalmedicine.org/publications and click on the “comanagement” button.)
But just as HM programs can be diverse in their organization, structure, and leadership, there is no single definition of comanagement, says Sylvia McKean, MD, SFHM, senior hospitalist at Brigham and Women’s Hospital in Boston. “You can have a very formal relationship where there’s a contract and where people are paid by whatever group is initiating the comanagement. There may be clear definitions in terms of their roles,” says Dr. McKean, an SHM board member who chaired the advisory panel that developed the comanagement white paper. “At the other extreme may be an informal relationship where you have a group of people in a community hospital who are available to manage medical problems when requested by specialists on a subset of patients.
“What really seems to distinguish comanagement from traditional medical consultations is that it implies equality in the relationship, even though the surgeon is often the attending of record,” as is practiced at Brigham and Women’s, Dr. McKean says. The comanaging hospitalist might follow the patient until discharge, rather than just seeing the patient once regarding the consultation question. “It’s more of a robust involvement of the hospitalist or internist, who really takes responsibility to make sure that medical conditions are actively managed, ideally before complications emerge.”
Eric Siegal, MD, SFHM, an intensivist with Aurora Medical Group in Wisconsin and an SHM board member, recommended developing comanagement services “carefully and methodically, paying close attention to consequences, intended and unintended”1 in a 2008 Journal of Hospital Medicine article. He tries to avoid broad generalizations about comanagement because “it’s applied variably across the industry. You’re going to find hospitalist programs that comanage very well and others that do it poorly.”
Dr. Siegal says he doesn’t think anyone in the field is “categorically anti-comanagement.”
However, he says it should be done thoughtfully, with clear goals in mind, and clearly defined roles and responsibilities. “Just showing up to see the specialists’ patients and calling it comanagement doesn’t necessarily mean you’re doing anything to make those patients’ care better,” he says.
Expert-Recommended
Demographic trends driving the spread of comanagement include an aging population of hospitalized patients with multiple comorbidities receiving surgical or other procedures that might not have been offered to them in the past. It fits with broader healthcare reform trends toward enhanced coordination and greater efficiency, illustrated by accountable-care organizations (ACOs).
Comanagement can be a growth and expansion opportunity for hospitalist groups, one that offers a defined niche and cements a group’s value to a hospital that wants improved relationships with surgeons. It also addresses the need for standardization and improved patient care in response to quality and safety concerns, and is associated with higher reported rates of satisfaction for surgeons and other staff and for patients.
“There are compelling reasons to do this, related to the limitations placed on resident work hours, which have affected neurosurgery and other surgical specialties profoundly, and the need to provide on-the-floor physician coverage more often and more consistently,” says UCSF hospitalist Andrew Auerbach, MD, MPH.

Dr. Auerbach is the lead author of a recently published study of the neurosurgery comanagement service at UCSF, which found that the program did not result in changes in patient mortality, readmission rates, or lengths of stay (LOS), although it was associated with reduced costs and perceptions of higher quality by professionals.5 Previous research has identified similar results with regard to increased professional satisfaction but without improvements in hard clinical outcomes.6
“Our paper supports the idea that clinical benefits to patients are not there yet,” Dr. Auerbach says. “Maybe we haven’t comanaged the right kinds of patients. Is there something else we have to think about? Maybe the real action is to be found post-hospitalization.”
Comanagement Caveats
In his landmark 2008 JHM article, Dr. Siegal pointed to potential drawbacks associated with comanagement. For example, surgeons, other specialists, and residents can become disengaged from the medical care of their hospitalized patients. He also noted the exacerbation of hospitalist and generalist manpower shortages, as well as the theoretical risk of fragmentation of care that is provided by multiple physician managers. If hospitalists are asked to do things that are outside of their skill set, that can be a problem, too. But the biggest concerns seem to center on the potential negative impact on job satisfaction.
“A fair and robust comanagement structure is an optimal delivery model,” says Christopher Massari, MD, hospitalist at PHMG/PeaceHealth Hospital in Springfield, Ore. “But because most hospitalist services are staffed 24/7, there’s a tendency for specialists and nurses to take advantage of hospitalists because they are ‘available.’ ”
Dr. Massari says he has experienced the “dumping” phenomenon firsthand. “It happens frequently. In the past few years, I have gradually developed the confidence and experience not to let it happen to me,” he says, “but I may inherit patients admitted by my hospitalist colleagues who may not feel as empowered or as skilled at avoiding it.”

Hospitalist dissatisfaction with comanagement is a problem with imperfect solutions, Dr. Cheng explains. “From my view, the biggest risk of comanagement is the inequality in relationships. Not every hospitalist has the temperament to do comanagement. If there is a perception that the partnership is unequal—favoring the surgeon—and if you feel like the junior partner in the relationship, it can be disheartening,” he says. “If the patient is not that sick, or if you feel you don’t have much to add professionally, it might feel like doing grunt work.”
Dr. Cheng also points to a theoretical increase in medical legal risk that the individual hospitalist faces. “With comanagement, you are taking responsibility not just for recommending care but for ensuring that the care is appropriately carried out, monitoring responses to treatment and dealing with delays,” he says. “When I talk to hospitalists, this fear of medical legal exposure comes up regularly.”
Rules of Engagement
SHM’s white paper offers a checklist of important issues to address when developing a comanagement service agreement. Issues include identifying champions from both sides of the collaboration, as well as from the hospital’s administration—which is an essential third party.
“Rules of engagement,” which should be spelled out in a written service agreement, include clarifying a shared vision, mutual goals and expectations, and the identified value proposition for both sides from the arrangement. Appropriate patients should be defined, along with what happens at night and on weekends, lines of authority and communication channels, and how conflicts will be addressed.
For Dr. McKean, the process really starts with “reflecting on your own core values.” Have a clear sense of the group’s goals, current staffing levels and pressures, and ability to add staff for a growing caseload, she says. “That’s where the rubber meets the road,” she adds. “You may want to hire people with a special interest in comanagement, and don’t try to have everyone in the group do everything.”
Jeanne Huddleston, MD, FACP, FHM, clinical scholar at the Mayo Clinic in Rochester, Minn., and past president of SHM, recommends dipping into the hospital’s database to get a better sense of the patient population targeted by a planned comanagement agreement—numbers, demographics, severity of illness, level of symptoms, length of stay, costs, and the like. Hospitalists also need to clearly understand the goals and needs of their comanagement partners—surgeons and other specialists—and of hospital administrators, who are an essential third party to the arrangement (see “What Hospitalists’ Comanagement Partners Are Saying,” above).
For Dr. Auerbach, the fundamental question is: “What are we specifically being asked to fix, and are we the right resource to fix the problem? Are we qualified to do it? Are we staffed to do it? Are we being given appropriate resources and authority to do it? And fundamentally, how are we going to know if we’ve made an improvement?” Quality metrics for comanagement—which should be gathered from the outset to provide a baseline—include in-hospital morbidity and mortality rates, 30-day mortality, hospital readmissions, length of hospital stay, costs of care, and overall return on investment for the hospital, as well as improved patient and professional satisfaction.
Experts agree that comanagement arrangements are unlikely to be self-sustaining from billing revenues alone, and thus will need some kind of support. In some cases, specialist groups can contribute the needed support, but more likely it is up to the hospital’s administration, based on its commitment to keeping its surgeons happy and busy in the operating suite, and on outcomes documenting financial and other benefits.
Medicare currently pays surgeons a global fee to manage their patient’s care associated with the surgery. Hospitalist comanagers typically bill under different codes for managing the patient’s medical conditions. But in an era of heightened regulatory scrutiny, health reform, and increased bundling of payments, this approach could be in for some revision, says Michael Ruhlen, MD, MHCM, FACHE, SFHM, chief medical officer of Carolinas Medical Centers in Charlotte, N.C.
ACOs will receive a global fee and apportion it among all the providers involved in a given episode of care, perhaps returning to capitation as a method to accomplish the apportionment, Dr. Ruhlen says. Hospitalists now developing comanagement agreements with surgeons should be aware that such changes are on the horizon, requiring all of the parties involved to rethink how their agreements are structured. In such cases, clearly demonstrating the value of both parties’ contributions to comanagement will be essential, he says.
Professional Impact
For The Cleveland Clinic’s Dr. Whinney, having a service agreement in place will help when physician reimbursement changes. “The thing you develop through these relationships is a sense of collegiality with your surgical colleagues, which is not something we’ve often seen before,” he says. “Particularly in large hospitals, where physicians don’t necessarily know each other, comanagement develops a true sense of collegiality.”
Felix Aguirre, MD, vice president of medical affairs for North Hollywood, Calif.-based IPC: The Hospitalist Company, says that a significant majority of hospitalized patients can benefit from an HM physician on the case.
“At IPC, we started with relationships [with the specialists], but as you go longer, you eventually move to more formal relationships, better defining what you are trying to do,” he says. “We’re still developing comanagement programs, and we’re trying to envision how they might relate to the readmission problem and to optimizing lengths of stay.”
Other industry leaders also ask how comanagement might contribute to the problem of hospital readmissions, perhaps with the hospitalist’s comanagement role continuing after the patient leaves the hospital. Others are exploring perioperative programs, broadly defined, with the hospitalist performing pre-operative assessments on an outpatient basis and helping to standardize processes and optimize the patient for surgery, thus reducing last-minute cancellations.
Ultimately, Dr. Huddleston says, these relationships should be built around putting the patient and the patient’s needs first, and patients don’t fit into neat boxes.
“Sometimes it’s comanagement, sometimes it’s just consultation. Each situation is discussed at the patient level,” she says. “As programs mature, all of these approaches can coexist. That’s where the service agreements become absolutely crucial, and they have to evolve as practice evolves. If you’re really basing it on patient need, you’ll probably end up with a hybrid of models.” TH
Larry Beresford is a freelance writer based in Oakland, Calif.
References
- Hospitalist co-management with surgeons and specialists. SHM website. Available at: www.hospitalmedicine.org/AM/Template.cfm?Section=Home&Template=/CM/HTMLDisplay.cfm&ContentID=25894. Accessed March 11, 2011.
- The core competencies in hospital medicine. ShM website. Available at: www.hospitalmedicine.org/Content/NavigationMenu/Education/CoreCurriculum/Core_Competencies.htm. Accessed March 11, 2011.
- SHM Co-Management Advisory Panel. A white paper on a guide to hospitalist/orthopedic surgery co-management, SHM website. Available at: www.hospitalmedicine.org/AM/Template.cfm?Section=White_Papers&Template=/CM/ContentDisplay.cfm&ContentID=25864.Accessed March 11, 2011.
- Siegal EM. Just because you can, doesn’t mean that you should: A call for the rational application of hospitalist comanagement. J Hosp Med. 2008;3(5):398-402.
- Auerbach AD, Wachter RM, Cheng HQ, Maselli J, McDermott M, Vittinghoff E, Burger MS. Comanagement of surgical patients between neurosurgeons and hospitalists. Arch Intern Med. 2010;170(22):2004-2010.
- Huddleston JM, Long KH, Naessens JM, et al. Medical and surgical comanagement after elective hip and knee arthroplasty: A randomized, controlled trial. Ann Intern Med. 2004;141(1):28-38.
- Pinzur MS, Gurza E, Kristopaitis T, et al. Hospitalist-orthopedic comanagement of high-risk patients undergoing lower extremity reconstruction surgery. Orthopedics. 2009; 32(7):495.
As patient care grows ever more complex, driven by demographic shifts and regulatory trends, hospitalists around the country continue to worry about the “dumping” practices of referring surgeons and other specialists. Negative nicknames like “admitologist,” “dischargologist,” or “glorified resident” reflect the concerns of some veteran physicians who find themselves doing what they perceive as “scut work”—merely processing the surgeons’ patients through the hospitalization.
Comanagement has been proposed as a solution to improve both patient care and professional satisfaction. But its promise can be eroded if the arrangement isn’t well planned and executed, experts say. Comanagement requires clearly defined roles, collaborative professional relationships, and some sense of equal standing with the surgeons or other specialists who call on hospitalists to care for their hospitalized patients’ medical needs.
“The growing formalization of comanagement agreements stems from prior tendency by some to view hospitalists as glorified house staff,” says Christopher Whinney, MD, FACP, FHM, director of comanagement at The Cleveland Clinic. “Hospitalists feel this is inappropriate, based on our skill set and scope of practice. There is also a concern that if a hospitalist group jumps in to do this without a clear service agreement in writing, that is where dumping can become a problem.”
Dr. Whinney is one of two expert mentors for hospitalists under a new SHM demonstration project called the Hospitalist Orthopedic Patient Service Comanagement Program, which is gathering data to evaluate its effectiveness on clinical and other outcomes. He has been working with five of the 10 participating HM groups, helping them define what it means to institutionalize formal comanagement relationships.
“Whatever your personal feelings about the comanagement relationship, pro or con, comanagement is going to be part of most hospital medicine groups’ repertoire of services,” says Hugo Quinny Cheng, MD, director of the comanagement with neurosurgery service at the University of California at San Francisco (UCSF) Medical Center. “You can try to avoid it, but if the medical center and the surgeons want it, there’s going to be pressure on your group to do it—or else they’ll look for another hospitalist group to do it.”
Dr. Cheng advises hospitalist group leaders make themselves aware of the trend and position themselves in a way to take advantage of it—or, at the very least, not be blindsided by it.
According to SHM data, 85% of hospitalist groups have done some kind of comanagement.1 It’s not explicitly listed by SHM as one of The Core Competencies in Hospital Medicine, but it might as well be, says Leslie Flores, MHA, SHM senior advisor, practice management, because aspects of comanagement are addressed throughout.2
Defined, Distinguished, Delineated
Comanagement is different from traditional medical consultations performed by hospitalists upon request, and also differs from cases in which the hospitalist is the admitting physician of record with sole management responsibilities while the patient is in the hospital. According to an SHM white paper, A Guide to Hospitalist/Orthopedic Surgery Comanagement, the concept involves shared responsibility, authority, and accountability for the care of hospitalized patients, typically with orthopedic surgeons or other specialties, and with the hospitalist managing the patient’s medical concerns, such as diabetes, congestive heart failure, or DVT.3 (SHM’s website is full of comanagement resources, including sample service agreements; visit www.hospitalmedicine.org/publications and click on the “comanagement” button.)
But just as HM programs can be diverse in their organization, structure, and leadership, there is no single definition of comanagement, says Sylvia McKean, MD, SFHM, senior hospitalist at Brigham and Women’s Hospital in Boston. “You can have a very formal relationship where there’s a contract and where people are paid by whatever group is initiating the comanagement. There may be clear definitions in terms of their roles,” says Dr. McKean, an SHM board member who chaired the advisory panel that developed the comanagement white paper. “At the other extreme may be an informal relationship where you have a group of people in a community hospital who are available to manage medical problems when requested by specialists on a subset of patients.
“What really seems to distinguish comanagement from traditional medical consultations is that it implies equality in the relationship, even though the surgeon is often the attending of record,” as is practiced at Brigham and Women’s, Dr. McKean says. The comanaging hospitalist might follow the patient until discharge, rather than just seeing the patient once regarding the consultation question. “It’s more of a robust involvement of the hospitalist or internist, who really takes responsibility to make sure that medical conditions are actively managed, ideally before complications emerge.”
Eric Siegal, MD, SFHM, an intensivist with Aurora Medical Group in Wisconsin and an SHM board member, recommended developing comanagement services “carefully and methodically, paying close attention to consequences, intended and unintended”1 in a 2008 Journal of Hospital Medicine article. He tries to avoid broad generalizations about comanagement because “it’s applied variably across the industry. You’re going to find hospitalist programs that comanage very well and others that do it poorly.”
Dr. Siegal says he doesn’t think anyone in the field is “categorically anti-comanagement.”
However, he says it should be done thoughtfully, with clear goals in mind, and clearly defined roles and responsibilities. “Just showing up to see the specialists’ patients and calling it comanagement doesn’t necessarily mean you’re doing anything to make those patients’ care better,” he says.
Expert-Recommended
Demographic trends driving the spread of comanagement include an aging population of hospitalized patients with multiple comorbidities receiving surgical or other procedures that might not have been offered to them in the past. It fits with broader healthcare reform trends toward enhanced coordination and greater efficiency, illustrated by accountable-care organizations (ACOs).
Comanagement can be a growth and expansion opportunity for hospitalist groups, one that offers a defined niche and cements a group’s value to a hospital that wants improved relationships with surgeons. It also addresses the need for standardization and improved patient care in response to quality and safety concerns, and is associated with higher reported rates of satisfaction for surgeons and other staff and for patients.
“There are compelling reasons to do this, related to the limitations placed on resident work hours, which have affected neurosurgery and other surgical specialties profoundly, and the need to provide on-the-floor physician coverage more often and more consistently,” says UCSF hospitalist Andrew Auerbach, MD, MPH.

Dr. Auerbach is the lead author of a recently published study of the neurosurgery comanagement service at UCSF, which found that the program did not result in changes in patient mortality, readmission rates, or lengths of stay (LOS), although it was associated with reduced costs and perceptions of higher quality by professionals.5 Previous research has identified similar results with regard to increased professional satisfaction but without improvements in hard clinical outcomes.6
“Our paper supports the idea that clinical benefits to patients are not there yet,” Dr. Auerbach says. “Maybe we haven’t comanaged the right kinds of patients. Is there something else we have to think about? Maybe the real action is to be found post-hospitalization.”
Comanagement Caveats
In his landmark 2008 JHM article, Dr. Siegal pointed to potential drawbacks associated with comanagement. For example, surgeons, other specialists, and residents can become disengaged from the medical care of their hospitalized patients. He also noted the exacerbation of hospitalist and generalist manpower shortages, as well as the theoretical risk of fragmentation of care that is provided by multiple physician managers. If hospitalists are asked to do things that are outside of their skill set, that can be a problem, too. But the biggest concerns seem to center on the potential negative impact on job satisfaction.
“A fair and robust comanagement structure is an optimal delivery model,” says Christopher Massari, MD, hospitalist at PHMG/PeaceHealth Hospital in Springfield, Ore. “But because most hospitalist services are staffed 24/7, there’s a tendency for specialists and nurses to take advantage of hospitalists because they are ‘available.’ ”
Dr. Massari says he has experienced the “dumping” phenomenon firsthand. “It happens frequently. In the past few years, I have gradually developed the confidence and experience not to let it happen to me,” he says, “but I may inherit patients admitted by my hospitalist colleagues who may not feel as empowered or as skilled at avoiding it.”

Hospitalist dissatisfaction with comanagement is a problem with imperfect solutions, Dr. Cheng explains. “From my view, the biggest risk of comanagement is the inequality in relationships. Not every hospitalist has the temperament to do comanagement. If there is a perception that the partnership is unequal—favoring the surgeon—and if you feel like the junior partner in the relationship, it can be disheartening,” he says. “If the patient is not that sick, or if you feel you don’t have much to add professionally, it might feel like doing grunt work.”
Dr. Cheng also points to a theoretical increase in medical legal risk that the individual hospitalist faces. “With comanagement, you are taking responsibility not just for recommending care but for ensuring that the care is appropriately carried out, monitoring responses to treatment and dealing with delays,” he says. “When I talk to hospitalists, this fear of medical legal exposure comes up regularly.”
Rules of Engagement
SHM’s white paper offers a checklist of important issues to address when developing a comanagement service agreement. Issues include identifying champions from both sides of the collaboration, as well as from the hospital’s administration—which is an essential third party.
“Rules of engagement,” which should be spelled out in a written service agreement, include clarifying a shared vision, mutual goals and expectations, and the identified value proposition for both sides from the arrangement. Appropriate patients should be defined, along with what happens at night and on weekends, lines of authority and communication channels, and how conflicts will be addressed.
For Dr. McKean, the process really starts with “reflecting on your own core values.” Have a clear sense of the group’s goals, current staffing levels and pressures, and ability to add staff for a growing caseload, she says. “That’s where the rubber meets the road,” she adds. “You may want to hire people with a special interest in comanagement, and don’t try to have everyone in the group do everything.”
Jeanne Huddleston, MD, FACP, FHM, clinical scholar at the Mayo Clinic in Rochester, Minn., and past president of SHM, recommends dipping into the hospital’s database to get a better sense of the patient population targeted by a planned comanagement agreement—numbers, demographics, severity of illness, level of symptoms, length of stay, costs, and the like. Hospitalists also need to clearly understand the goals and needs of their comanagement partners—surgeons and other specialists—and of hospital administrators, who are an essential third party to the arrangement (see “What Hospitalists’ Comanagement Partners Are Saying,” above).
For Dr. Auerbach, the fundamental question is: “What are we specifically being asked to fix, and are we the right resource to fix the problem? Are we qualified to do it? Are we staffed to do it? Are we being given appropriate resources and authority to do it? And fundamentally, how are we going to know if we’ve made an improvement?” Quality metrics for comanagement—which should be gathered from the outset to provide a baseline—include in-hospital morbidity and mortality rates, 30-day mortality, hospital readmissions, length of hospital stay, costs of care, and overall return on investment for the hospital, as well as improved patient and professional satisfaction.
Experts agree that comanagement arrangements are unlikely to be self-sustaining from billing revenues alone, and thus will need some kind of support. In some cases, specialist groups can contribute the needed support, but more likely it is up to the hospital’s administration, based on its commitment to keeping its surgeons happy and busy in the operating suite, and on outcomes documenting financial and other benefits.
Medicare currently pays surgeons a global fee to manage their patient’s care associated with the surgery. Hospitalist comanagers typically bill under different codes for managing the patient’s medical conditions. But in an era of heightened regulatory scrutiny, health reform, and increased bundling of payments, this approach could be in for some revision, says Michael Ruhlen, MD, MHCM, FACHE, SFHM, chief medical officer of Carolinas Medical Centers in Charlotte, N.C.
ACOs will receive a global fee and apportion it among all the providers involved in a given episode of care, perhaps returning to capitation as a method to accomplish the apportionment, Dr. Ruhlen says. Hospitalists now developing comanagement agreements with surgeons should be aware that such changes are on the horizon, requiring all of the parties involved to rethink how their agreements are structured. In such cases, clearly demonstrating the value of both parties’ contributions to comanagement will be essential, he says.
Professional Impact
For The Cleveland Clinic’s Dr. Whinney, having a service agreement in place will help when physician reimbursement changes. “The thing you develop through these relationships is a sense of collegiality with your surgical colleagues, which is not something we’ve often seen before,” he says. “Particularly in large hospitals, where physicians don’t necessarily know each other, comanagement develops a true sense of collegiality.”
Felix Aguirre, MD, vice president of medical affairs for North Hollywood, Calif.-based IPC: The Hospitalist Company, says that a significant majority of hospitalized patients can benefit from an HM physician on the case.
“At IPC, we started with relationships [with the specialists], but as you go longer, you eventually move to more formal relationships, better defining what you are trying to do,” he says. “We’re still developing comanagement programs, and we’re trying to envision how they might relate to the readmission problem and to optimizing lengths of stay.”
Other industry leaders also ask how comanagement might contribute to the problem of hospital readmissions, perhaps with the hospitalist’s comanagement role continuing after the patient leaves the hospital. Others are exploring perioperative programs, broadly defined, with the hospitalist performing pre-operative assessments on an outpatient basis and helping to standardize processes and optimize the patient for surgery, thus reducing last-minute cancellations.
Ultimately, Dr. Huddleston says, these relationships should be built around putting the patient and the patient’s needs first, and patients don’t fit into neat boxes.
“Sometimes it’s comanagement, sometimes it’s just consultation. Each situation is discussed at the patient level,” she says. “As programs mature, all of these approaches can coexist. That’s where the service agreements become absolutely crucial, and they have to evolve as practice evolves. If you’re really basing it on patient need, you’ll probably end up with a hybrid of models.” TH
Larry Beresford is a freelance writer based in Oakland, Calif.
References
- Hospitalist co-management with surgeons and specialists. SHM website. Available at: www.hospitalmedicine.org/AM/Template.cfm?Section=Home&Template=/CM/HTMLDisplay.cfm&ContentID=25894. Accessed March 11, 2011.
- The core competencies in hospital medicine. ShM website. Available at: www.hospitalmedicine.org/Content/NavigationMenu/Education/CoreCurriculum/Core_Competencies.htm. Accessed March 11, 2011.
- SHM Co-Management Advisory Panel. A white paper on a guide to hospitalist/orthopedic surgery co-management, SHM website. Available at: www.hospitalmedicine.org/AM/Template.cfm?Section=White_Papers&Template=/CM/ContentDisplay.cfm&ContentID=25864.Accessed March 11, 2011.
- Siegal EM. Just because you can, doesn’t mean that you should: A call for the rational application of hospitalist comanagement. J Hosp Med. 2008;3(5):398-402.
- Auerbach AD, Wachter RM, Cheng HQ, Maselli J, McDermott M, Vittinghoff E, Burger MS. Comanagement of surgical patients between neurosurgeons and hospitalists. Arch Intern Med. 2010;170(22):2004-2010.
- Huddleston JM, Long KH, Naessens JM, et al. Medical and surgical comanagement after elective hip and knee arthroplasty: A randomized, controlled trial. Ann Intern Med. 2004;141(1):28-38.
- Pinzur MS, Gurza E, Kristopaitis T, et al. Hospitalist-orthopedic comanagement of high-risk patients undergoing lower extremity reconstruction surgery. Orthopedics. 2009; 32(7):495.
As patient care grows ever more complex, driven by demographic shifts and regulatory trends, hospitalists around the country continue to worry about the “dumping” practices of referring surgeons and other specialists. Negative nicknames like “admitologist,” “dischargologist,” or “glorified resident” reflect the concerns of some veteran physicians who find themselves doing what they perceive as “scut work”—merely processing the surgeons’ patients through the hospitalization.
Comanagement has been proposed as a solution to improve both patient care and professional satisfaction. But its promise can be eroded if the arrangement isn’t well planned and executed, experts say. Comanagement requires clearly defined roles, collaborative professional relationships, and some sense of equal standing with the surgeons or other specialists who call on hospitalists to care for their hospitalized patients’ medical needs.
“The growing formalization of comanagement agreements stems from prior tendency by some to view hospitalists as glorified house staff,” says Christopher Whinney, MD, FACP, FHM, director of comanagement at The Cleveland Clinic. “Hospitalists feel this is inappropriate, based on our skill set and scope of practice. There is also a concern that if a hospitalist group jumps in to do this without a clear service agreement in writing, that is where dumping can become a problem.”
Dr. Whinney is one of two expert mentors for hospitalists under a new SHM demonstration project called the Hospitalist Orthopedic Patient Service Comanagement Program, which is gathering data to evaluate its effectiveness on clinical and other outcomes. He has been working with five of the 10 participating HM groups, helping them define what it means to institutionalize formal comanagement relationships.
“Whatever your personal feelings about the comanagement relationship, pro or con, comanagement is going to be part of most hospital medicine groups’ repertoire of services,” says Hugo Quinny Cheng, MD, director of the comanagement with neurosurgery service at the University of California at San Francisco (UCSF) Medical Center. “You can try to avoid it, but if the medical center and the surgeons want it, there’s going to be pressure on your group to do it—or else they’ll look for another hospitalist group to do it.”
Dr. Cheng advises hospitalist group leaders make themselves aware of the trend and position themselves in a way to take advantage of it—or, at the very least, not be blindsided by it.
According to SHM data, 85% of hospitalist groups have done some kind of comanagement.1 It’s not explicitly listed by SHM as one of The Core Competencies in Hospital Medicine, but it might as well be, says Leslie Flores, MHA, SHM senior advisor, practice management, because aspects of comanagement are addressed throughout.2
Defined, Distinguished, Delineated
Comanagement is different from traditional medical consultations performed by hospitalists upon request, and also differs from cases in which the hospitalist is the admitting physician of record with sole management responsibilities while the patient is in the hospital. According to an SHM white paper, A Guide to Hospitalist/Orthopedic Surgery Comanagement, the concept involves shared responsibility, authority, and accountability for the care of hospitalized patients, typically with orthopedic surgeons or other specialties, and with the hospitalist managing the patient’s medical concerns, such as diabetes, congestive heart failure, or DVT.3 (SHM’s website is full of comanagement resources, including sample service agreements; visit www.hospitalmedicine.org/publications and click on the “comanagement” button.)
But just as HM programs can be diverse in their organization, structure, and leadership, there is no single definition of comanagement, says Sylvia McKean, MD, SFHM, senior hospitalist at Brigham and Women’s Hospital in Boston. “You can have a very formal relationship where there’s a contract and where people are paid by whatever group is initiating the comanagement. There may be clear definitions in terms of their roles,” says Dr. McKean, an SHM board member who chaired the advisory panel that developed the comanagement white paper. “At the other extreme may be an informal relationship where you have a group of people in a community hospital who are available to manage medical problems when requested by specialists on a subset of patients.
“What really seems to distinguish comanagement from traditional medical consultations is that it implies equality in the relationship, even though the surgeon is often the attending of record,” as is practiced at Brigham and Women’s, Dr. McKean says. The comanaging hospitalist might follow the patient until discharge, rather than just seeing the patient once regarding the consultation question. “It’s more of a robust involvement of the hospitalist or internist, who really takes responsibility to make sure that medical conditions are actively managed, ideally before complications emerge.”
Eric Siegal, MD, SFHM, an intensivist with Aurora Medical Group in Wisconsin and an SHM board member, recommended developing comanagement services “carefully and methodically, paying close attention to consequences, intended and unintended”1 in a 2008 Journal of Hospital Medicine article. He tries to avoid broad generalizations about comanagement because “it’s applied variably across the industry. You’re going to find hospitalist programs that comanage very well and others that do it poorly.”
Dr. Siegal says he doesn’t think anyone in the field is “categorically anti-comanagement.”
However, he says it should be done thoughtfully, with clear goals in mind, and clearly defined roles and responsibilities. “Just showing up to see the specialists’ patients and calling it comanagement doesn’t necessarily mean you’re doing anything to make those patients’ care better,” he says.
Expert-Recommended
Demographic trends driving the spread of comanagement include an aging population of hospitalized patients with multiple comorbidities receiving surgical or other procedures that might not have been offered to them in the past. It fits with broader healthcare reform trends toward enhanced coordination and greater efficiency, illustrated by accountable-care organizations (ACOs).
Comanagement can be a growth and expansion opportunity for hospitalist groups, one that offers a defined niche and cements a group’s value to a hospital that wants improved relationships with surgeons. It also addresses the need for standardization and improved patient care in response to quality and safety concerns, and is associated with higher reported rates of satisfaction for surgeons and other staff and for patients.
“There are compelling reasons to do this, related to the limitations placed on resident work hours, which have affected neurosurgery and other surgical specialties profoundly, and the need to provide on-the-floor physician coverage more often and more consistently,” says UCSF hospitalist Andrew Auerbach, MD, MPH.

Dr. Auerbach is the lead author of a recently published study of the neurosurgery comanagement service at UCSF, which found that the program did not result in changes in patient mortality, readmission rates, or lengths of stay (LOS), although it was associated with reduced costs and perceptions of higher quality by professionals.5 Previous research has identified similar results with regard to increased professional satisfaction but without improvements in hard clinical outcomes.6
“Our paper supports the idea that clinical benefits to patients are not there yet,” Dr. Auerbach says. “Maybe we haven’t comanaged the right kinds of patients. Is there something else we have to think about? Maybe the real action is to be found post-hospitalization.”
Comanagement Caveats
In his landmark 2008 JHM article, Dr. Siegal pointed to potential drawbacks associated with comanagement. For example, surgeons, other specialists, and residents can become disengaged from the medical care of their hospitalized patients. He also noted the exacerbation of hospitalist and generalist manpower shortages, as well as the theoretical risk of fragmentation of care that is provided by multiple physician managers. If hospitalists are asked to do things that are outside of their skill set, that can be a problem, too. But the biggest concerns seem to center on the potential negative impact on job satisfaction.
“A fair and robust comanagement structure is an optimal delivery model,” says Christopher Massari, MD, hospitalist at PHMG/PeaceHealth Hospital in Springfield, Ore. “But because most hospitalist services are staffed 24/7, there’s a tendency for specialists and nurses to take advantage of hospitalists because they are ‘available.’ ”
Dr. Massari says he has experienced the “dumping” phenomenon firsthand. “It happens frequently. In the past few years, I have gradually developed the confidence and experience not to let it happen to me,” he says, “but I may inherit patients admitted by my hospitalist colleagues who may not feel as empowered or as skilled at avoiding it.”

Hospitalist dissatisfaction with comanagement is a problem with imperfect solutions, Dr. Cheng explains. “From my view, the biggest risk of comanagement is the inequality in relationships. Not every hospitalist has the temperament to do comanagement. If there is a perception that the partnership is unequal—favoring the surgeon—and if you feel like the junior partner in the relationship, it can be disheartening,” he says. “If the patient is not that sick, or if you feel you don’t have much to add professionally, it might feel like doing grunt work.”
Dr. Cheng also points to a theoretical increase in medical legal risk that the individual hospitalist faces. “With comanagement, you are taking responsibility not just for recommending care but for ensuring that the care is appropriately carried out, monitoring responses to treatment and dealing with delays,” he says. “When I talk to hospitalists, this fear of medical legal exposure comes up regularly.”
Rules of Engagement
SHM’s white paper offers a checklist of important issues to address when developing a comanagement service agreement. Issues include identifying champions from both sides of the collaboration, as well as from the hospital’s administration—which is an essential third party.
“Rules of engagement,” which should be spelled out in a written service agreement, include clarifying a shared vision, mutual goals and expectations, and the identified value proposition for both sides from the arrangement. Appropriate patients should be defined, along with what happens at night and on weekends, lines of authority and communication channels, and how conflicts will be addressed.
For Dr. McKean, the process really starts with “reflecting on your own core values.” Have a clear sense of the group’s goals, current staffing levels and pressures, and ability to add staff for a growing caseload, she says. “That’s where the rubber meets the road,” she adds. “You may want to hire people with a special interest in comanagement, and don’t try to have everyone in the group do everything.”
Jeanne Huddleston, MD, FACP, FHM, clinical scholar at the Mayo Clinic in Rochester, Minn., and past president of SHM, recommends dipping into the hospital’s database to get a better sense of the patient population targeted by a planned comanagement agreement—numbers, demographics, severity of illness, level of symptoms, length of stay, costs, and the like. Hospitalists also need to clearly understand the goals and needs of their comanagement partners—surgeons and other specialists—and of hospital administrators, who are an essential third party to the arrangement (see “What Hospitalists’ Comanagement Partners Are Saying,” above).
For Dr. Auerbach, the fundamental question is: “What are we specifically being asked to fix, and are we the right resource to fix the problem? Are we qualified to do it? Are we staffed to do it? Are we being given appropriate resources and authority to do it? And fundamentally, how are we going to know if we’ve made an improvement?” Quality metrics for comanagement—which should be gathered from the outset to provide a baseline—include in-hospital morbidity and mortality rates, 30-day mortality, hospital readmissions, length of hospital stay, costs of care, and overall return on investment for the hospital, as well as improved patient and professional satisfaction.
Experts agree that comanagement arrangements are unlikely to be self-sustaining from billing revenues alone, and thus will need some kind of support. In some cases, specialist groups can contribute the needed support, but more likely it is up to the hospital’s administration, based on its commitment to keeping its surgeons happy and busy in the operating suite, and on outcomes documenting financial and other benefits.
Medicare currently pays surgeons a global fee to manage their patient’s care associated with the surgery. Hospitalist comanagers typically bill under different codes for managing the patient’s medical conditions. But in an era of heightened regulatory scrutiny, health reform, and increased bundling of payments, this approach could be in for some revision, says Michael Ruhlen, MD, MHCM, FACHE, SFHM, chief medical officer of Carolinas Medical Centers in Charlotte, N.C.
ACOs will receive a global fee and apportion it among all the providers involved in a given episode of care, perhaps returning to capitation as a method to accomplish the apportionment, Dr. Ruhlen says. Hospitalists now developing comanagement agreements with surgeons should be aware that such changes are on the horizon, requiring all of the parties involved to rethink how their agreements are structured. In such cases, clearly demonstrating the value of both parties’ contributions to comanagement will be essential, he says.
Professional Impact
For The Cleveland Clinic’s Dr. Whinney, having a service agreement in place will help when physician reimbursement changes. “The thing you develop through these relationships is a sense of collegiality with your surgical colleagues, which is not something we’ve often seen before,” he says. “Particularly in large hospitals, where physicians don’t necessarily know each other, comanagement develops a true sense of collegiality.”
Felix Aguirre, MD, vice president of medical affairs for North Hollywood, Calif.-based IPC: The Hospitalist Company, says that a significant majority of hospitalized patients can benefit from an HM physician on the case.
“At IPC, we started with relationships [with the specialists], but as you go longer, you eventually move to more formal relationships, better defining what you are trying to do,” he says. “We’re still developing comanagement programs, and we’re trying to envision how they might relate to the readmission problem and to optimizing lengths of stay.”
Other industry leaders also ask how comanagement might contribute to the problem of hospital readmissions, perhaps with the hospitalist’s comanagement role continuing after the patient leaves the hospital. Others are exploring perioperative programs, broadly defined, with the hospitalist performing pre-operative assessments on an outpatient basis and helping to standardize processes and optimize the patient for surgery, thus reducing last-minute cancellations.
Ultimately, Dr. Huddleston says, these relationships should be built around putting the patient and the patient’s needs first, and patients don’t fit into neat boxes.
“Sometimes it’s comanagement, sometimes it’s just consultation. Each situation is discussed at the patient level,” she says. “As programs mature, all of these approaches can coexist. That’s where the service agreements become absolutely crucial, and they have to evolve as practice evolves. If you’re really basing it on patient need, you’ll probably end up with a hybrid of models.” TH
Larry Beresford is a freelance writer based in Oakland, Calif.
References
- Hospitalist co-management with surgeons and specialists. SHM website. Available at: www.hospitalmedicine.org/AM/Template.cfm?Section=Home&Template=/CM/HTMLDisplay.cfm&ContentID=25894. Accessed March 11, 2011.
- The core competencies in hospital medicine. ShM website. Available at: www.hospitalmedicine.org/Content/NavigationMenu/Education/CoreCurriculum/Core_Competencies.htm. Accessed March 11, 2011.
- SHM Co-Management Advisory Panel. A white paper on a guide to hospitalist/orthopedic surgery co-management, SHM website. Available at: www.hospitalmedicine.org/AM/Template.cfm?Section=White_Papers&Template=/CM/ContentDisplay.cfm&ContentID=25864.Accessed March 11, 2011.
- Siegal EM. Just because you can, doesn’t mean that you should: A call for the rational application of hospitalist comanagement. J Hosp Med. 2008;3(5):398-402.
- Auerbach AD, Wachter RM, Cheng HQ, Maselli J, McDermott M, Vittinghoff E, Burger MS. Comanagement of surgical patients between neurosurgeons and hospitalists. Arch Intern Med. 2010;170(22):2004-2010.
- Huddleston JM, Long KH, Naessens JM, et al. Medical and surgical comanagement after elective hip and knee arthroplasty: A randomized, controlled trial. Ann Intern Med. 2004;141(1):28-38.
- Pinzur MS, Gurza E, Kristopaitis T, et al. Hospitalist-orthopedic comanagement of high-risk patients undergoing lower extremity reconstruction surgery. Orthopedics. 2009; 32(7):495.
Under the Microscope: Medication Reconciliation

Boston hospitalist Jeffrey Schnipper, MD, MPH, FHM, is no stranger to quality initiatives aimed at medication reconciliation (MR). His research at Brigham and Women’s Hospital and Massachusetts General Hospital revealed a potential reduction of serious medical errors per patient to 0.3 from 1.4 in the past four years.
“I think those are achievable results,” he says. “This is all about doing those things better than we were always doing before.”
Now Dr. Schnipper will work to bring similar results to hospitals across America as principal investigator for SHM’s three-year, multicenter, MR quality-improvement study. The study, funded by a $1.5 million grant from the Agency for Healthcare Research and Quality (AHRQ), will develop a database to research the best practices in MR and provide a mentored implementation model for other hospitals to use.
The project also will include a package of materials and tools adaptable for any hospital, as well as an implementation guide with the mentored implementation model. “It really should be everything a site needs to improve its MR process,” says Dr. Schnipper, director of clinical research at the Brigham and Women’s Hospital Hospitalist Service and assistant professor at Harvard Medical School.
According to The Institute for Safe Medication Practices, MR is the process of comparing a patient’s medication orders with their previously prescribed medication regimen and communicating any necessary changes to patients and their next providers of care. More than 1.3 million medication errors occur annually in the U.S.; MR has been shown to eliminate as many as half of those errors and 20% of adverse medical events.
JoAnne Resnic, MBA, BSN, RN, senior project manager at SHM, says SHM will use the grant to fund research investigators, SHM’s project staff, and the development of a database for each of the study’s six sites to house their data collection and provide site-specific progress reports throughout the course of the study. SHM is working with consultants and physician co-investigators, a steering committee of nationally recognized thought leaders in medication reconciliation, a research pharmacist, and others to “help us take a pretty deep dive into the process and, hopefully, explain why some interventions work in some places and why they may not in others,” Resnic says.
According to Dr. Schnipper, SHM will conduct an interrupted time series at the sites, collecting baseline data for six months at each, then for 21 months after interventions begin. The study specifically will address 13 facets of medication reconciliation, scoring the facets based on their effectiveness (see Table 1, p. 6).
Each facet will be re-evaluated when different parts of the intervention are turned on, which should reveal “the most active ingredients that correspond to improved outcomes,” he says.
Dr. Schnipper emphasizes that there are two integral facets for improving MR: patient education and access to preadmission medication sources. Technology could be an answer to advancing these components, but it is not the sole link. “There may be ways to serve up the discharged medication list in a patient-friendly way using some IT or an image library of medications to help patients,” he says. “I do not foresee a medication reconciliation IT application, unfortunately.”
AHRQ selected SHM for the grant after a “peer review process [that] evaluates the merit of the applications against very rigorous criteria,” an AHRQ representative says. SHM was chosen “based upon its leadership and previous experience in medication reconciliation.” TH
Kevin Stevens is a staff writer based in New Jersey.

Boston hospitalist Jeffrey Schnipper, MD, MPH, FHM, is no stranger to quality initiatives aimed at medication reconciliation (MR). His research at Brigham and Women’s Hospital and Massachusetts General Hospital revealed a potential reduction of serious medical errors per patient to 0.3 from 1.4 in the past four years.
“I think those are achievable results,” he says. “This is all about doing those things better than we were always doing before.”
Now Dr. Schnipper will work to bring similar results to hospitals across America as principal investigator for SHM’s three-year, multicenter, MR quality-improvement study. The study, funded by a $1.5 million grant from the Agency for Healthcare Research and Quality (AHRQ), will develop a database to research the best practices in MR and provide a mentored implementation model for other hospitals to use.
The project also will include a package of materials and tools adaptable for any hospital, as well as an implementation guide with the mentored implementation model. “It really should be everything a site needs to improve its MR process,” says Dr. Schnipper, director of clinical research at the Brigham and Women’s Hospital Hospitalist Service and assistant professor at Harvard Medical School.
According to The Institute for Safe Medication Practices, MR is the process of comparing a patient’s medication orders with their previously prescribed medication regimen and communicating any necessary changes to patients and their next providers of care. More than 1.3 million medication errors occur annually in the U.S.; MR has been shown to eliminate as many as half of those errors and 20% of adverse medical events.
JoAnne Resnic, MBA, BSN, RN, senior project manager at SHM, says SHM will use the grant to fund research investigators, SHM’s project staff, and the development of a database for each of the study’s six sites to house their data collection and provide site-specific progress reports throughout the course of the study. SHM is working with consultants and physician co-investigators, a steering committee of nationally recognized thought leaders in medication reconciliation, a research pharmacist, and others to “help us take a pretty deep dive into the process and, hopefully, explain why some interventions work in some places and why they may not in others,” Resnic says.
According to Dr. Schnipper, SHM will conduct an interrupted time series at the sites, collecting baseline data for six months at each, then for 21 months after interventions begin. The study specifically will address 13 facets of medication reconciliation, scoring the facets based on their effectiveness (see Table 1, p. 6).
Each facet will be re-evaluated when different parts of the intervention are turned on, which should reveal “the most active ingredients that correspond to improved outcomes,” he says.
Dr. Schnipper emphasizes that there are two integral facets for improving MR: patient education and access to preadmission medication sources. Technology could be an answer to advancing these components, but it is not the sole link. “There may be ways to serve up the discharged medication list in a patient-friendly way using some IT or an image library of medications to help patients,” he says. “I do not foresee a medication reconciliation IT application, unfortunately.”
AHRQ selected SHM for the grant after a “peer review process [that] evaluates the merit of the applications against very rigorous criteria,” an AHRQ representative says. SHM was chosen “based upon its leadership and previous experience in medication reconciliation.” TH
Kevin Stevens is a staff writer based in New Jersey.

Boston hospitalist Jeffrey Schnipper, MD, MPH, FHM, is no stranger to quality initiatives aimed at medication reconciliation (MR). His research at Brigham and Women’s Hospital and Massachusetts General Hospital revealed a potential reduction of serious medical errors per patient to 0.3 from 1.4 in the past four years.
“I think those are achievable results,” he says. “This is all about doing those things better than we were always doing before.”
Now Dr. Schnipper will work to bring similar results to hospitals across America as principal investigator for SHM’s three-year, multicenter, MR quality-improvement study. The study, funded by a $1.5 million grant from the Agency for Healthcare Research and Quality (AHRQ), will develop a database to research the best practices in MR and provide a mentored implementation model for other hospitals to use.
The project also will include a package of materials and tools adaptable for any hospital, as well as an implementation guide with the mentored implementation model. “It really should be everything a site needs to improve its MR process,” says Dr. Schnipper, director of clinical research at the Brigham and Women’s Hospital Hospitalist Service and assistant professor at Harvard Medical School.
According to The Institute for Safe Medication Practices, MR is the process of comparing a patient’s medication orders with their previously prescribed medication regimen and communicating any necessary changes to patients and their next providers of care. More than 1.3 million medication errors occur annually in the U.S.; MR has been shown to eliminate as many as half of those errors and 20% of adverse medical events.
JoAnne Resnic, MBA, BSN, RN, senior project manager at SHM, says SHM will use the grant to fund research investigators, SHM’s project staff, and the development of a database for each of the study’s six sites to house their data collection and provide site-specific progress reports throughout the course of the study. SHM is working with consultants and physician co-investigators, a steering committee of nationally recognized thought leaders in medication reconciliation, a research pharmacist, and others to “help us take a pretty deep dive into the process and, hopefully, explain why some interventions work in some places and why they may not in others,” Resnic says.
According to Dr. Schnipper, SHM will conduct an interrupted time series at the sites, collecting baseline data for six months at each, then for 21 months after interventions begin. The study specifically will address 13 facets of medication reconciliation, scoring the facets based on their effectiveness (see Table 1, p. 6).
Each facet will be re-evaluated when different parts of the intervention are turned on, which should reveal “the most active ingredients that correspond to improved outcomes,” he says.
Dr. Schnipper emphasizes that there are two integral facets for improving MR: patient education and access to preadmission medication sources. Technology could be an answer to advancing these components, but it is not the sole link. “There may be ways to serve up the discharged medication list in a patient-friendly way using some IT or an image library of medications to help patients,” he says. “I do not foresee a medication reconciliation IT application, unfortunately.”
AHRQ selected SHM for the grant after a “peer review process [that] evaluates the merit of the applications against very rigorous criteria,” an AHRQ representative says. SHM was chosen “based upon its leadership and previous experience in medication reconciliation.” TH
Kevin Stevens is a staff writer based in New Jersey.
Letters to the Editor
Pennsylvania group director sounds the call for hospitalist emancipation
Terms such as partners, associates, and K-1 are much less common in HM than other specialties. Instead, we are more familiar with such terms as medical director, employee, corporation-owned, hospital-owned, W-2. In most HM practices, there tends to be more of a hierarchal structure with unequal distribution of say and authority; 100% of the decision-making authority lies with two or three people in the group or organization.
I look around at my friends’ practices in other fields, the majority being privately owned with partnership track and equitable standing in the group, and I contrast that with what I see in nearly every HM group in my area. In HM, our fellow hospitalist must answer to his or her medical director, who then answers to the hospital administration. In many of the large, multistate corporations, the medical director answers to hospital administration as well as to a regional director, who then answers to the CMO of the corporation, who then answers to the CEO.
Rarely do you see a field of medicine that has such little autonomy. I believe it is time for hospitalists to step up to the plate and create practices in which we answer to ourselves and determine our own destinies.
Another phenomenon in HM demonstrates how everyone wants a piece of the HM action. In a 20-mile radius of where I practice, there are HM groups that have been started by specialists in other fields, including infectious disease, pulmonary, emergency medicine, and anesthesia. A cardiology acquaintance of mine recently started three hospitalist practices—single-handedly. These new additions are in addition to the HM groups started by hospital administrations and large multistate corporations.
The majority, but certainly not all, of these people or entities have very little understanding of what running a hospitalist practice entails. They might understand an HM practice to the extent that I understand how a hip replacement is done, procedurally, from my reading of a textbook or an operative note. Unless one currently practices or has recently practiced as a hospitalist, then it is difficult to fully grasp all the nuances of running an HM practice. Never have I seen a GI physician start up a cardiology group, nor have I seen an ER group start up an endocrine practice. Yet the majority of HM practices nationwide are started and controlled by entities other than the hospitalists themselves.
This recent epiphany has prompted me to sound the call for hospitalist emancipation. With a new generation of HM leaders, who now have both clinical and administrative experience in HM, it is time for hospitalists, not other specialists nor hospital administrators, to pave the course of our future in light of emerging healthcare reforms. Of course, we still need to work intimately with our parent hospitals, align our goals and vision, and be mindful of the construct in which HM is practiced. But I believe it is time for us to take control of our practices, because only we know what’s best for our patients and our fellow hospitalists.
Edward Ma, MD, hospitalist,
managing partner, Medical Inpatient Care Associates,
West Chester, Pa.,
president, The Hospitalist Consulting Group, LLC
ACGME not the only game in town for graduate medical education
I enjoy reading your column, but feel I must correct you regarding graduate medical education. You stated in your January 2011 column (“Turn to ACGME for Transfer, Resident Supervision Rules,” p. 39) that all U.S. postgraduate physician-training programs are governed by rules of the ACGME. Please note that there are hundreds of osteopathic postgraduate training programs throughout the country that are governed by the rules of the American Osteopathic Association and the osteopathic specialty colleges that sponsor these residencies and fellowships. If you need more information regarding this segment of postgraduate training, I would be more than happy to share more information with you.
Joanne Kaiser-Smith, DO,
FACOI, FACP, assistant dean,
Graduate Medical Education,
University of Medicine and Dentistry New Jersey,
School of Osteopathic Medicine, Stratford, N.J.
Dr. Hospitalist responds:
Dr. Kaiser-Smith: Thank you for your letter to the editor. You are absolutely correct. My intention was not to overlook the postgraduate training of osteopathic physicians, which, as you pointed out, is governed differently from the postgraduate allopathic training programs.
Thank you for sharing this information with our readers.
New Zealanders have pharmaceutical choice, but most choose subsidized meds
Dr. Williams’ excellent article (see “Hospitalist Down Under,” Feb-ruary 2011, p. 1) about his experiences at a country hospital in New Zealand and comparisons with the U.S. system has had a warm reception in this country. However, one statement he makes needs correction.
Dr. Williams states that if a drug was not available on the New Zealand “formulary” (the Pharmaceutical Schedule), then it is not available. The New Zealand government has separate drug evaluation (Medsafe) and funding (PHARMAC) agencies, each of which has different remits. Medsafe decides which medicines are safe and effective to use in New Zealand. PHARMAC decides which medicines will be funded by the government, and publishes this list in the Pharmaceutical Schedule.
Any Medsafe-approved drug can be prescribed for New Zealand patients, even those not on the schedule. About 20% of medicines used in New Zealand are purchased privately.
Our experience is that when faced with a choice, New Zealanders usually opt for government-funded medicines (those subsidized by PHARMAC). For this reason, the majority of medicines prescribed for New Zealand patients are funded by the government.
Thanks again for the excellent article.
Simon England,
communications manager,
PHARMAC, Wellington,
New Zealand
Pennsylvania group director sounds the call for hospitalist emancipation
Terms such as partners, associates, and K-1 are much less common in HM than other specialties. Instead, we are more familiar with such terms as medical director, employee, corporation-owned, hospital-owned, W-2. In most HM practices, there tends to be more of a hierarchal structure with unequal distribution of say and authority; 100% of the decision-making authority lies with two or three people in the group or organization.
I look around at my friends’ practices in other fields, the majority being privately owned with partnership track and equitable standing in the group, and I contrast that with what I see in nearly every HM group in my area. In HM, our fellow hospitalist must answer to his or her medical director, who then answers to the hospital administration. In many of the large, multistate corporations, the medical director answers to hospital administration as well as to a regional director, who then answers to the CMO of the corporation, who then answers to the CEO.
Rarely do you see a field of medicine that has such little autonomy. I believe it is time for hospitalists to step up to the plate and create practices in which we answer to ourselves and determine our own destinies.
Another phenomenon in HM demonstrates how everyone wants a piece of the HM action. In a 20-mile radius of where I practice, there are HM groups that have been started by specialists in other fields, including infectious disease, pulmonary, emergency medicine, and anesthesia. A cardiology acquaintance of mine recently started three hospitalist practices—single-handedly. These new additions are in addition to the HM groups started by hospital administrations and large multistate corporations.
The majority, but certainly not all, of these people or entities have very little understanding of what running a hospitalist practice entails. They might understand an HM practice to the extent that I understand how a hip replacement is done, procedurally, from my reading of a textbook or an operative note. Unless one currently practices or has recently practiced as a hospitalist, then it is difficult to fully grasp all the nuances of running an HM practice. Never have I seen a GI physician start up a cardiology group, nor have I seen an ER group start up an endocrine practice. Yet the majority of HM practices nationwide are started and controlled by entities other than the hospitalists themselves.
This recent epiphany has prompted me to sound the call for hospitalist emancipation. With a new generation of HM leaders, who now have both clinical and administrative experience in HM, it is time for hospitalists, not other specialists nor hospital administrators, to pave the course of our future in light of emerging healthcare reforms. Of course, we still need to work intimately with our parent hospitals, align our goals and vision, and be mindful of the construct in which HM is practiced. But I believe it is time for us to take control of our practices, because only we know what’s best for our patients and our fellow hospitalists.
Edward Ma, MD, hospitalist,
managing partner, Medical Inpatient Care Associates,
West Chester, Pa.,
president, The Hospitalist Consulting Group, LLC
ACGME not the only game in town for graduate medical education
I enjoy reading your column, but feel I must correct you regarding graduate medical education. You stated in your January 2011 column (“Turn to ACGME for Transfer, Resident Supervision Rules,” p. 39) that all U.S. postgraduate physician-training programs are governed by rules of the ACGME. Please note that there are hundreds of osteopathic postgraduate training programs throughout the country that are governed by the rules of the American Osteopathic Association and the osteopathic specialty colleges that sponsor these residencies and fellowships. If you need more information regarding this segment of postgraduate training, I would be more than happy to share more information with you.
Joanne Kaiser-Smith, DO,
FACOI, FACP, assistant dean,
Graduate Medical Education,
University of Medicine and Dentistry New Jersey,
School of Osteopathic Medicine, Stratford, N.J.
Dr. Hospitalist responds:
Dr. Kaiser-Smith: Thank you for your letter to the editor. You are absolutely correct. My intention was not to overlook the postgraduate training of osteopathic physicians, which, as you pointed out, is governed differently from the postgraduate allopathic training programs.
Thank you for sharing this information with our readers.
New Zealanders have pharmaceutical choice, but most choose subsidized meds
Dr. Williams’ excellent article (see “Hospitalist Down Under,” Feb-ruary 2011, p. 1) about his experiences at a country hospital in New Zealand and comparisons with the U.S. system has had a warm reception in this country. However, one statement he makes needs correction.
Dr. Williams states that if a drug was not available on the New Zealand “formulary” (the Pharmaceutical Schedule), then it is not available. The New Zealand government has separate drug evaluation (Medsafe) and funding (PHARMAC) agencies, each of which has different remits. Medsafe decides which medicines are safe and effective to use in New Zealand. PHARMAC decides which medicines will be funded by the government, and publishes this list in the Pharmaceutical Schedule.
Any Medsafe-approved drug can be prescribed for New Zealand patients, even those not on the schedule. About 20% of medicines used in New Zealand are purchased privately.
Our experience is that when faced with a choice, New Zealanders usually opt for government-funded medicines (those subsidized by PHARMAC). For this reason, the majority of medicines prescribed for New Zealand patients are funded by the government.
Thanks again for the excellent article.
Simon England,
communications manager,
PHARMAC, Wellington,
New Zealand
Pennsylvania group director sounds the call for hospitalist emancipation
Terms such as partners, associates, and K-1 are much less common in HM than other specialties. Instead, we are more familiar with such terms as medical director, employee, corporation-owned, hospital-owned, W-2. In most HM practices, there tends to be more of a hierarchal structure with unequal distribution of say and authority; 100% of the decision-making authority lies with two or three people in the group or organization.
I look around at my friends’ practices in other fields, the majority being privately owned with partnership track and equitable standing in the group, and I contrast that with what I see in nearly every HM group in my area. In HM, our fellow hospitalist must answer to his or her medical director, who then answers to the hospital administration. In many of the large, multistate corporations, the medical director answers to hospital administration as well as to a regional director, who then answers to the CMO of the corporation, who then answers to the CEO.
Rarely do you see a field of medicine that has such little autonomy. I believe it is time for hospitalists to step up to the plate and create practices in which we answer to ourselves and determine our own destinies.
Another phenomenon in HM demonstrates how everyone wants a piece of the HM action. In a 20-mile radius of where I practice, there are HM groups that have been started by specialists in other fields, including infectious disease, pulmonary, emergency medicine, and anesthesia. A cardiology acquaintance of mine recently started three hospitalist practices—single-handedly. These new additions are in addition to the HM groups started by hospital administrations and large multistate corporations.
The majority, but certainly not all, of these people or entities have very little understanding of what running a hospitalist practice entails. They might understand an HM practice to the extent that I understand how a hip replacement is done, procedurally, from my reading of a textbook or an operative note. Unless one currently practices or has recently practiced as a hospitalist, then it is difficult to fully grasp all the nuances of running an HM practice. Never have I seen a GI physician start up a cardiology group, nor have I seen an ER group start up an endocrine practice. Yet the majority of HM practices nationwide are started and controlled by entities other than the hospitalists themselves.
This recent epiphany has prompted me to sound the call for hospitalist emancipation. With a new generation of HM leaders, who now have both clinical and administrative experience in HM, it is time for hospitalists, not other specialists nor hospital administrators, to pave the course of our future in light of emerging healthcare reforms. Of course, we still need to work intimately with our parent hospitals, align our goals and vision, and be mindful of the construct in which HM is practiced. But I believe it is time for us to take control of our practices, because only we know what’s best for our patients and our fellow hospitalists.
Edward Ma, MD, hospitalist,
managing partner, Medical Inpatient Care Associates,
West Chester, Pa.,
president, The Hospitalist Consulting Group, LLC
ACGME not the only game in town for graduate medical education
I enjoy reading your column, but feel I must correct you regarding graduate medical education. You stated in your January 2011 column (“Turn to ACGME for Transfer, Resident Supervision Rules,” p. 39) that all U.S. postgraduate physician-training programs are governed by rules of the ACGME. Please note that there are hundreds of osteopathic postgraduate training programs throughout the country that are governed by the rules of the American Osteopathic Association and the osteopathic specialty colleges that sponsor these residencies and fellowships. If you need more information regarding this segment of postgraduate training, I would be more than happy to share more information with you.
Joanne Kaiser-Smith, DO,
FACOI, FACP, assistant dean,
Graduate Medical Education,
University of Medicine and Dentistry New Jersey,
School of Osteopathic Medicine, Stratford, N.J.
Dr. Hospitalist responds:
Dr. Kaiser-Smith: Thank you for your letter to the editor. You are absolutely correct. My intention was not to overlook the postgraduate training of osteopathic physicians, which, as you pointed out, is governed differently from the postgraduate allopathic training programs.
Thank you for sharing this information with our readers.
New Zealanders have pharmaceutical choice, but most choose subsidized meds
Dr. Williams’ excellent article (see “Hospitalist Down Under,” Feb-ruary 2011, p. 1) about his experiences at a country hospital in New Zealand and comparisons with the U.S. system has had a warm reception in this country. However, one statement he makes needs correction.
Dr. Williams states that if a drug was not available on the New Zealand “formulary” (the Pharmaceutical Schedule), then it is not available. The New Zealand government has separate drug evaluation (Medsafe) and funding (PHARMAC) agencies, each of which has different remits. Medsafe decides which medicines are safe and effective to use in New Zealand. PHARMAC decides which medicines will be funded by the government, and publishes this list in the Pharmaceutical Schedule.
Any Medsafe-approved drug can be prescribed for New Zealand patients, even those not on the schedule. About 20% of medicines used in New Zealand are purchased privately.
Our experience is that when faced with a choice, New Zealanders usually opt for government-funded medicines (those subsidized by PHARMAC). For this reason, the majority of medicines prescribed for New Zealand patients are funded by the government.
Thanks again for the excellent article.
Simon England,
communications manager,
PHARMAC, Wellington,
New Zealand
When Should a Patient with Ascites Receive Spontaneous Bacterial Peritonitis (SBP) Prophylaxis?
Case
A 54-year-old man with end-stage liver disease (ESLD) and no prior history of spontaneous bacterial peritonitis (SBP) presents with increasing shortness of breath and abdominal distention. He is admitted for worsening volume overload. The patient reveals that he has not been compliant with his diuretics. On the day of admission, a large-volume paracentesis is performed. Results are significant for a white blood cell count of 150 cells/mm3 and a total protein of 0.9 g/ul. The patient is started on furosemide and spironolactone, and his symptoms significantly improve throughout his hospitalization. His medications are reconciled on the day of discharge. He is not on any antibiotics for SBP prophylaxis; should he be? In general, which patients with ascites should receive SBP prophylaxis?
Overview
Spontaneous bacterial peritonitis is an infection of ascitic fluid that occurs in the absence of an indentified intra-abdominal source of infection or inflammation, i.e., perforation or abscess.1 It is diagnosed when the polymorphonuclear cell (PMN) count in the ascitic fluid is equal to or greater than 250 cells/mm3, with or without positive cultures.
SBP is a significant cause of morbidity and mortality in patients with cirrhosis, with the mortality rate approaching 20% to 40%.2 Of the 32% to 34% of cirrhotic patients who present with, or develop, a bacterial infection during their hospitalization, 25% are due to SBP.1 Changes in gut motility, mucosal defense, and microflora allow for translocation of bacteria into enteric lymph nodes and the bloodstream, resulting in seeding of the peritoneal fluid and SBP.1 Alterations in both systemic and localized immune defenses, both of which are reduced in patients with liver disease, also play a role in SBP pathogenesis (see Table 1, p. 41).
Current evidence supports the use of a third-generation cephalosporin or amoxicillin/clavulanate for initial treatment of SBP, as most infections are caused by gram-negative bacilli, in particular E. coli (see Table 2 on p. 41 and Table 3 on p. 42).1 Alternatively, an oral or intravenous fluoroquinolone could be used if the prevalence of fluoroquinolone-resistant organisms is low.1
Due to the frequency and morbidity associated with SBP, there is great interest in preventing it. However, the use of prophylactic antibiotics needs to be restricted to patients who are at highest risk of developing SBP. According to numerous studies, patients at high risk for SBP include:
- Patients with a prior SBP history;
- Patients admitted with a gastrointestinal bleed; and
- Patients with low total protein content in their ascitic fluid (defined as <1.5 g/ul).1
SBP History
Spontaneous bacterial peritonitis portends bad outcomes. The one-year mortality rate after an episode of SBP is 30% to 50%.1 Furthermore, patients who have recovered from a previous episode of SBP have a 70% chance of developing another episode of SBP in that year.1,2 In one study, norfloxacin was shown to decrease the one-year risk of SBP to 20% from 68% in patients with a history of SBP.3 Additionally, the likelihood of developing SBP from gram-negative bacilli was reduced to 3% from 60%. In order to be efficacious, norfloxacin must be given daily. When fluoroquinolones are prescribed less than once daily, there is a higher rate of fluoroquinolone resistant organisms in the stool.1
Though once-daily dosing of norfloxacin is recommended to decrease the promotion of resistant organisms in prophylaxis against SBP, ciprofloxacin once weekly is acceptable. In a group of patients with low ascitic protein content, with or without a history of SBP, weekly ciprofloxacin has been shown to decrease SBP incidence to 4% from 22% at six months.4 In regard to length of treatment, recommendations are to continue prophylactic antibiotics until resolution of ascites, the patient receives a transplant, or the patient passes away.1
Saab et al studied the impact of oral antibiotic prophylaxis in patients with advanced liver disease on morbidity and mortality.5 The authors examined prospective, randomized, controlled trials that compared high-risk cirrhotic patients receiving oral antibiotic prophylaxis for SBP with groups receiving placebo or no intervention. Eight studies totaling 647 patients were included in the analysis.
The overall mortality rate for patients treated with SBP prophylaxis was 16%, compared with 25% for the control group. Groups treated with prophylactic antibiotics also had a lower incidence of all infections (6.2% vs. 22.2% in the control groups). Additionally, a survival benefit was seen at three months in the group that received prophylactic antibiotics.
The absolute risk reduction with prophylactic antibiotics for primary prevention of SBP was 8% with a number needed to treat of 13. The incidence of gastrointestinal (GI) bleeding, renal failure, and hepatic failure did not significantly differ between treatment and control groups. Thus, survival benefit is thought to be related to the reduced incidence of infections in the group receiving prophylactic antibiotics.5
History of GI Bleeding
The incidence of developing SBP in cirrhotics with an active GI bleed is anywhere from 20% to 45%.1,2 For those with ascites of any etiology and a GI bleed, the incidence can be as high as 60%.5 In general, bacterial infections are frequently diagnosed in patients with cirrhosis and GI bleeding, and have been documented in 22% of these patients within the first 48 hours after admission. According to several studies, that percentage can reach as high as 35% to 66% within seven to 14 days of admission.6 A seven-day course of antibiotics, or antibiotics until discharge, is generally acceptable for SBP prophylaxis in the setting of ascites and GI bleeding (see Table 2, right).1
Bernard et al performed a meta-analysis of five trials to assess the efficacy of antibiotic prophylaxis in the prevention of infections and effect on survival in patients with cirrhosis and GI bleeding. Out of 534 patients, 264 were treated with antibiotics between four and 10 days, and 270 did not receive any antibiotics.
The endpoints of the study were infection, bacteremia and/or SBP; incidence of SBP; and death. Antibiotic prophylaxis not only increased the mean survival rate by 9.1%, but also increased the mean percentage of patients free of infection (32% improvement); bacteremia and/or SBP (19% improvement); and SBP (7% improvement).7
Low Ascitic Fluid Protein
Of the three major risk factors for SBP, ascitic fluid protein content is the most debated. Guarner et al studied the risk of first community-acquired SBP in cirrhotics with low ascitic fluid protein.2 Patients were seen immediately after discharge from the hospital and at two- to three-month intervals. Of the 109 hospitalized patients, 23 (21%) developed SBP, nine of which developed SBP during their hospitalization. The one-year cumulative probability of SBP in these patients with low ascitic fluid protein levels was 35%.
During this study, the authors also looked at 20 different patient variables on admission and found that two parameters—high bilirubin (>3.2mg/dL) and low platelet count (<98,000 cells/ul)—were associated with an increased risk of SBP. This is consistent with studies showing that patients with higher Model for End-Stage Liver Disease (MELD) or Child-Pugh scores, indicating more severe liver disease, are at increased risk for SBP. This likely is the reason SBP prophylaxis is recommended for patients with an elevated bilirubin, and higher Child-Pugh scores, by the American Association for the Study of Liver Disease (see Table 2, p. 41).
Runyon et al showed that 15% of patients with low ascitic fluid protein developed SBP during their hospitalization, as compared with 2% of patients with ascitic fluid levels greater than 1 g/dl.8 A randomized, non-placebo-controlled trial by Navasa et al evaluating 70 cirrhotic patients with low ascitic ascitic protein levels showed a lower probability of developing SBP in the group placed on SBP prophylaxis with norfloxacin (5% vs. 31%).9 Six-month mortality rate was also lower (19% vs. 36%).
In contrast to the previous studies, Grothe et al found that the presence of SBP was not related to ascitic protein content.10 Given conflicting studies, controversy still remains on whether patients with low ascitic protein should receive long-term prophylactic antibiotics.
Antibiotic Drawbacks
The consensus in the literature is that patients with ascites who are admitted with a GI bleed, or those with a history of SBP, should be placed on SBP prophylaxis. However, patients placed on long-term antibiotics are at risk for developing bacterial resistance. Bacterial resistance in cultures taken from cirrhotic patients with SBP has increased over the last decade, particularly in gram-negative bacteria.5 Patients who receive antibiotics in the pre-transplant setting also are at risk for post-transplant fungal infections.
Additionally, the antibiotic of choice for SBP prophylaxis is typically a fluoroquinolone, which can be expensive. However, numerous studies have shown that the cost of initiating prophylactic therapy for SBP in patients with a prior episode of SBP can be cheaper than treating SBP after diagnosis.2
Back to the Case
Our patient’s paracentesis was negative for SBP. Additionally, he does not have a history of SBP, nor does he have an active GI bleed. His only possible indication for SBP prophylaxis is low ascitic protein concentration. His electrolytes were all within normal limits. Additionally, total bilirubin was only slightly elevated at 2.3 mg/dL.
Based on the American Association for the Study of Liver Diseases guidelines, the patient was not started on SBP prophylaxis. Additionally, given his history of medication noncompliance, there is concern that he might not take the antibiotics as prescribed, thus leading to the development of bacterial resistance and more serious infections in the future.
Bottom Line
Patients with ascites and a prior episode of SBP, and those admitted to the hospital for GI bleeding, should be placed on SBP prophylaxis. SBP prophylaxis for low protein ascitic fluid remains controversial but is recommended by the American Association for the Study of Liver Diseases. TH
Dr. del Pino Jones is a hospitalist at the University of Colorado Denver.
References
- Ghassemi S, Garcia-Tsao G. Prevention and treatment of infections in patients with cirrhosis. Best Pract Res Clin Gastroenterol. 2007;21(1):77-93.
- Guarner C, Solà R, Soriono G, et al. Risk of a first community-acquired spontaneous bacterial peritonitis in cirrhotics with low ascitic fluid protein levels. Gastroenterology. 1999;117(2):414-419.
- Ginés P, Rimola A, Planas R, et al. Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: results of a double-blind, placebo-controlled trial. Hepatology. 1990;12(4 Pt 1):716-724.
- Rolachon A, Cordier L, Bacq Y, et al. Ciprofloxacin and long-term prevention of spontaneous bacterial peritonitis: results of a prospective controlled trial. Hepatology. 1995;22(4 Pt 1):1171-1174.
- Saab S, Hernandez J, Chi AC, Tong MJ. Oral antibiotic prophylaxis reduces spontaneous bacterial peritonitis occurrence and improves short-term survival in cirrhosis: a meta-analysis. Am J Gastroenterol. 2009;104(4):993-1001.
- Deschênes M, Villeneuve J. Risk factors for the development of bacterial infections in hospitalized patients with cirrhosis. Am J Gastroenterol. 1999;94(8):2193-2197.
- Bernard B, Grangé J, Khac EN, Amiot X, Opolon P, Poynard T. Antibiotic prophylaxis for the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding: a meta-analysis. Hepatology. 1999;29(6):1655-1661.
- Runyon B. Low-protein-concentration ascitic fluid is predisposed to spontaneous bacterial peritonitis. Gastroenterology. 1986;91(6):1343-1346.
- Navasa M, Fernandez J, Montoliu S, et al. Randomized, double-blind, placebo-controlled trial evaluating norfloxacin in the primary prophylaxis of spontaneous bacterial peritonitis in cirrhotics with renal impairment, hyponatremia or severe liver failure. J Hepatol. 2006;44(Supp2):S51.
- Grothe W, Lottere E, Fleig W. Factors predictive for spontaneous bacterial peritonitis (SBP) under routine inpatient conditions in patients with cirrhosis: a prospective multicenter trial. J Hepatol. 1990;34(4):547.
Case
A 54-year-old man with end-stage liver disease (ESLD) and no prior history of spontaneous bacterial peritonitis (SBP) presents with increasing shortness of breath and abdominal distention. He is admitted for worsening volume overload. The patient reveals that he has not been compliant with his diuretics. On the day of admission, a large-volume paracentesis is performed. Results are significant for a white blood cell count of 150 cells/mm3 and a total protein of 0.9 g/ul. The patient is started on furosemide and spironolactone, and his symptoms significantly improve throughout his hospitalization. His medications are reconciled on the day of discharge. He is not on any antibiotics for SBP prophylaxis; should he be? In general, which patients with ascites should receive SBP prophylaxis?
Overview
Spontaneous bacterial peritonitis is an infection of ascitic fluid that occurs in the absence of an indentified intra-abdominal source of infection or inflammation, i.e., perforation or abscess.1 It is diagnosed when the polymorphonuclear cell (PMN) count in the ascitic fluid is equal to or greater than 250 cells/mm3, with or without positive cultures.
SBP is a significant cause of morbidity and mortality in patients with cirrhosis, with the mortality rate approaching 20% to 40%.2 Of the 32% to 34% of cirrhotic patients who present with, or develop, a bacterial infection during their hospitalization, 25% are due to SBP.1 Changes in gut motility, mucosal defense, and microflora allow for translocation of bacteria into enteric lymph nodes and the bloodstream, resulting in seeding of the peritoneal fluid and SBP.1 Alterations in both systemic and localized immune defenses, both of which are reduced in patients with liver disease, also play a role in SBP pathogenesis (see Table 1, p. 41).
Current evidence supports the use of a third-generation cephalosporin or amoxicillin/clavulanate for initial treatment of SBP, as most infections are caused by gram-negative bacilli, in particular E. coli (see Table 2 on p. 41 and Table 3 on p. 42).1 Alternatively, an oral or intravenous fluoroquinolone could be used if the prevalence of fluoroquinolone-resistant organisms is low.1
Due to the frequency and morbidity associated with SBP, there is great interest in preventing it. However, the use of prophylactic antibiotics needs to be restricted to patients who are at highest risk of developing SBP. According to numerous studies, patients at high risk for SBP include:
- Patients with a prior SBP history;
- Patients admitted with a gastrointestinal bleed; and
- Patients with low total protein content in their ascitic fluid (defined as <1.5 g/ul).1
SBP History
Spontaneous bacterial peritonitis portends bad outcomes. The one-year mortality rate after an episode of SBP is 30% to 50%.1 Furthermore, patients who have recovered from a previous episode of SBP have a 70% chance of developing another episode of SBP in that year.1,2 In one study, norfloxacin was shown to decrease the one-year risk of SBP to 20% from 68% in patients with a history of SBP.3 Additionally, the likelihood of developing SBP from gram-negative bacilli was reduced to 3% from 60%. In order to be efficacious, norfloxacin must be given daily. When fluoroquinolones are prescribed less than once daily, there is a higher rate of fluoroquinolone resistant organisms in the stool.1
Though once-daily dosing of norfloxacin is recommended to decrease the promotion of resistant organisms in prophylaxis against SBP, ciprofloxacin once weekly is acceptable. In a group of patients with low ascitic protein content, with or without a history of SBP, weekly ciprofloxacin has been shown to decrease SBP incidence to 4% from 22% at six months.4 In regard to length of treatment, recommendations are to continue prophylactic antibiotics until resolution of ascites, the patient receives a transplant, or the patient passes away.1
Saab et al studied the impact of oral antibiotic prophylaxis in patients with advanced liver disease on morbidity and mortality.5 The authors examined prospective, randomized, controlled trials that compared high-risk cirrhotic patients receiving oral antibiotic prophylaxis for SBP with groups receiving placebo or no intervention. Eight studies totaling 647 patients were included in the analysis.
The overall mortality rate for patients treated with SBP prophylaxis was 16%, compared with 25% for the control group. Groups treated with prophylactic antibiotics also had a lower incidence of all infections (6.2% vs. 22.2% in the control groups). Additionally, a survival benefit was seen at three months in the group that received prophylactic antibiotics.
The absolute risk reduction with prophylactic antibiotics for primary prevention of SBP was 8% with a number needed to treat of 13. The incidence of gastrointestinal (GI) bleeding, renal failure, and hepatic failure did not significantly differ between treatment and control groups. Thus, survival benefit is thought to be related to the reduced incidence of infections in the group receiving prophylactic antibiotics.5
History of GI Bleeding
The incidence of developing SBP in cirrhotics with an active GI bleed is anywhere from 20% to 45%.1,2 For those with ascites of any etiology and a GI bleed, the incidence can be as high as 60%.5 In general, bacterial infections are frequently diagnosed in patients with cirrhosis and GI bleeding, and have been documented in 22% of these patients within the first 48 hours after admission. According to several studies, that percentage can reach as high as 35% to 66% within seven to 14 days of admission.6 A seven-day course of antibiotics, or antibiotics until discharge, is generally acceptable for SBP prophylaxis in the setting of ascites and GI bleeding (see Table 2, right).1
Bernard et al performed a meta-analysis of five trials to assess the efficacy of antibiotic prophylaxis in the prevention of infections and effect on survival in patients with cirrhosis and GI bleeding. Out of 534 patients, 264 were treated with antibiotics between four and 10 days, and 270 did not receive any antibiotics.
The endpoints of the study were infection, bacteremia and/or SBP; incidence of SBP; and death. Antibiotic prophylaxis not only increased the mean survival rate by 9.1%, but also increased the mean percentage of patients free of infection (32% improvement); bacteremia and/or SBP (19% improvement); and SBP (7% improvement).7
Low Ascitic Fluid Protein
Of the three major risk factors for SBP, ascitic fluid protein content is the most debated. Guarner et al studied the risk of first community-acquired SBP in cirrhotics with low ascitic fluid protein.2 Patients were seen immediately after discharge from the hospital and at two- to three-month intervals. Of the 109 hospitalized patients, 23 (21%) developed SBP, nine of which developed SBP during their hospitalization. The one-year cumulative probability of SBP in these patients with low ascitic fluid protein levels was 35%.
During this study, the authors also looked at 20 different patient variables on admission and found that two parameters—high bilirubin (>3.2mg/dL) and low platelet count (<98,000 cells/ul)—were associated with an increased risk of SBP. This is consistent with studies showing that patients with higher Model for End-Stage Liver Disease (MELD) or Child-Pugh scores, indicating more severe liver disease, are at increased risk for SBP. This likely is the reason SBP prophylaxis is recommended for patients with an elevated bilirubin, and higher Child-Pugh scores, by the American Association for the Study of Liver Disease (see Table 2, p. 41).
Runyon et al showed that 15% of patients with low ascitic fluid protein developed SBP during their hospitalization, as compared with 2% of patients with ascitic fluid levels greater than 1 g/dl.8 A randomized, non-placebo-controlled trial by Navasa et al evaluating 70 cirrhotic patients with low ascitic ascitic protein levels showed a lower probability of developing SBP in the group placed on SBP prophylaxis with norfloxacin (5% vs. 31%).9 Six-month mortality rate was also lower (19% vs. 36%).
In contrast to the previous studies, Grothe et al found that the presence of SBP was not related to ascitic protein content.10 Given conflicting studies, controversy still remains on whether patients with low ascitic protein should receive long-term prophylactic antibiotics.
Antibiotic Drawbacks
The consensus in the literature is that patients with ascites who are admitted with a GI bleed, or those with a history of SBP, should be placed on SBP prophylaxis. However, patients placed on long-term antibiotics are at risk for developing bacterial resistance. Bacterial resistance in cultures taken from cirrhotic patients with SBP has increased over the last decade, particularly in gram-negative bacteria.5 Patients who receive antibiotics in the pre-transplant setting also are at risk for post-transplant fungal infections.
Additionally, the antibiotic of choice for SBP prophylaxis is typically a fluoroquinolone, which can be expensive. However, numerous studies have shown that the cost of initiating prophylactic therapy for SBP in patients with a prior episode of SBP can be cheaper than treating SBP after diagnosis.2
Back to the Case
Our patient’s paracentesis was negative for SBP. Additionally, he does not have a history of SBP, nor does he have an active GI bleed. His only possible indication for SBP prophylaxis is low ascitic protein concentration. His electrolytes were all within normal limits. Additionally, total bilirubin was only slightly elevated at 2.3 mg/dL.
Based on the American Association for the Study of Liver Diseases guidelines, the patient was not started on SBP prophylaxis. Additionally, given his history of medication noncompliance, there is concern that he might not take the antibiotics as prescribed, thus leading to the development of bacterial resistance and more serious infections in the future.
Bottom Line
Patients with ascites and a prior episode of SBP, and those admitted to the hospital for GI bleeding, should be placed on SBP prophylaxis. SBP prophylaxis for low protein ascitic fluid remains controversial but is recommended by the American Association for the Study of Liver Diseases. TH
Dr. del Pino Jones is a hospitalist at the University of Colorado Denver.
References
- Ghassemi S, Garcia-Tsao G. Prevention and treatment of infections in patients with cirrhosis. Best Pract Res Clin Gastroenterol. 2007;21(1):77-93.
- Guarner C, Solà R, Soriono G, et al. Risk of a first community-acquired spontaneous bacterial peritonitis in cirrhotics with low ascitic fluid protein levels. Gastroenterology. 1999;117(2):414-419.
- Ginés P, Rimola A, Planas R, et al. Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: results of a double-blind, placebo-controlled trial. Hepatology. 1990;12(4 Pt 1):716-724.
- Rolachon A, Cordier L, Bacq Y, et al. Ciprofloxacin and long-term prevention of spontaneous bacterial peritonitis: results of a prospective controlled trial. Hepatology. 1995;22(4 Pt 1):1171-1174.
- Saab S, Hernandez J, Chi AC, Tong MJ. Oral antibiotic prophylaxis reduces spontaneous bacterial peritonitis occurrence and improves short-term survival in cirrhosis: a meta-analysis. Am J Gastroenterol. 2009;104(4):993-1001.
- Deschênes M, Villeneuve J. Risk factors for the development of bacterial infections in hospitalized patients with cirrhosis. Am J Gastroenterol. 1999;94(8):2193-2197.
- Bernard B, Grangé J, Khac EN, Amiot X, Opolon P, Poynard T. Antibiotic prophylaxis for the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding: a meta-analysis. Hepatology. 1999;29(6):1655-1661.
- Runyon B. Low-protein-concentration ascitic fluid is predisposed to spontaneous bacterial peritonitis. Gastroenterology. 1986;91(6):1343-1346.
- Navasa M, Fernandez J, Montoliu S, et al. Randomized, double-blind, placebo-controlled trial evaluating norfloxacin in the primary prophylaxis of spontaneous bacterial peritonitis in cirrhotics with renal impairment, hyponatremia or severe liver failure. J Hepatol. 2006;44(Supp2):S51.
- Grothe W, Lottere E, Fleig W. Factors predictive for spontaneous bacterial peritonitis (SBP) under routine inpatient conditions in patients with cirrhosis: a prospective multicenter trial. J Hepatol. 1990;34(4):547.
Case
A 54-year-old man with end-stage liver disease (ESLD) and no prior history of spontaneous bacterial peritonitis (SBP) presents with increasing shortness of breath and abdominal distention. He is admitted for worsening volume overload. The patient reveals that he has not been compliant with his diuretics. On the day of admission, a large-volume paracentesis is performed. Results are significant for a white blood cell count of 150 cells/mm3 and a total protein of 0.9 g/ul. The patient is started on furosemide and spironolactone, and his symptoms significantly improve throughout his hospitalization. His medications are reconciled on the day of discharge. He is not on any antibiotics for SBP prophylaxis; should he be? In general, which patients with ascites should receive SBP prophylaxis?
Overview
Spontaneous bacterial peritonitis is an infection of ascitic fluid that occurs in the absence of an indentified intra-abdominal source of infection or inflammation, i.e., perforation or abscess.1 It is diagnosed when the polymorphonuclear cell (PMN) count in the ascitic fluid is equal to or greater than 250 cells/mm3, with or without positive cultures.
SBP is a significant cause of morbidity and mortality in patients with cirrhosis, with the mortality rate approaching 20% to 40%.2 Of the 32% to 34% of cirrhotic patients who present with, or develop, a bacterial infection during their hospitalization, 25% are due to SBP.1 Changes in gut motility, mucosal defense, and microflora allow for translocation of bacteria into enteric lymph nodes and the bloodstream, resulting in seeding of the peritoneal fluid and SBP.1 Alterations in both systemic and localized immune defenses, both of which are reduced in patients with liver disease, also play a role in SBP pathogenesis (see Table 1, p. 41).
Current evidence supports the use of a third-generation cephalosporin or amoxicillin/clavulanate for initial treatment of SBP, as most infections are caused by gram-negative bacilli, in particular E. coli (see Table 2 on p. 41 and Table 3 on p. 42).1 Alternatively, an oral or intravenous fluoroquinolone could be used if the prevalence of fluoroquinolone-resistant organisms is low.1
Due to the frequency and morbidity associated with SBP, there is great interest in preventing it. However, the use of prophylactic antibiotics needs to be restricted to patients who are at highest risk of developing SBP. According to numerous studies, patients at high risk for SBP include:
- Patients with a prior SBP history;
- Patients admitted with a gastrointestinal bleed; and
- Patients with low total protein content in their ascitic fluid (defined as <1.5 g/ul).1
SBP History
Spontaneous bacterial peritonitis portends bad outcomes. The one-year mortality rate after an episode of SBP is 30% to 50%.1 Furthermore, patients who have recovered from a previous episode of SBP have a 70% chance of developing another episode of SBP in that year.1,2 In one study, norfloxacin was shown to decrease the one-year risk of SBP to 20% from 68% in patients with a history of SBP.3 Additionally, the likelihood of developing SBP from gram-negative bacilli was reduced to 3% from 60%. In order to be efficacious, norfloxacin must be given daily. When fluoroquinolones are prescribed less than once daily, there is a higher rate of fluoroquinolone resistant organisms in the stool.1
Though once-daily dosing of norfloxacin is recommended to decrease the promotion of resistant organisms in prophylaxis against SBP, ciprofloxacin once weekly is acceptable. In a group of patients with low ascitic protein content, with or without a history of SBP, weekly ciprofloxacin has been shown to decrease SBP incidence to 4% from 22% at six months.4 In regard to length of treatment, recommendations are to continue prophylactic antibiotics until resolution of ascites, the patient receives a transplant, or the patient passes away.1
Saab et al studied the impact of oral antibiotic prophylaxis in patients with advanced liver disease on morbidity and mortality.5 The authors examined prospective, randomized, controlled trials that compared high-risk cirrhotic patients receiving oral antibiotic prophylaxis for SBP with groups receiving placebo or no intervention. Eight studies totaling 647 patients were included in the analysis.
The overall mortality rate for patients treated with SBP prophylaxis was 16%, compared with 25% for the control group. Groups treated with prophylactic antibiotics also had a lower incidence of all infections (6.2% vs. 22.2% in the control groups). Additionally, a survival benefit was seen at three months in the group that received prophylactic antibiotics.
The absolute risk reduction with prophylactic antibiotics for primary prevention of SBP was 8% with a number needed to treat of 13. The incidence of gastrointestinal (GI) bleeding, renal failure, and hepatic failure did not significantly differ between treatment and control groups. Thus, survival benefit is thought to be related to the reduced incidence of infections in the group receiving prophylactic antibiotics.5
History of GI Bleeding
The incidence of developing SBP in cirrhotics with an active GI bleed is anywhere from 20% to 45%.1,2 For those with ascites of any etiology and a GI bleed, the incidence can be as high as 60%.5 In general, bacterial infections are frequently diagnosed in patients with cirrhosis and GI bleeding, and have been documented in 22% of these patients within the first 48 hours after admission. According to several studies, that percentage can reach as high as 35% to 66% within seven to 14 days of admission.6 A seven-day course of antibiotics, or antibiotics until discharge, is generally acceptable for SBP prophylaxis in the setting of ascites and GI bleeding (see Table 2, right).1
Bernard et al performed a meta-analysis of five trials to assess the efficacy of antibiotic prophylaxis in the prevention of infections and effect on survival in patients with cirrhosis and GI bleeding. Out of 534 patients, 264 were treated with antibiotics between four and 10 days, and 270 did not receive any antibiotics.
The endpoints of the study were infection, bacteremia and/or SBP; incidence of SBP; and death. Antibiotic prophylaxis not only increased the mean survival rate by 9.1%, but also increased the mean percentage of patients free of infection (32% improvement); bacteremia and/or SBP (19% improvement); and SBP (7% improvement).7
Low Ascitic Fluid Protein
Of the three major risk factors for SBP, ascitic fluid protein content is the most debated. Guarner et al studied the risk of first community-acquired SBP in cirrhotics with low ascitic fluid protein.2 Patients were seen immediately after discharge from the hospital and at two- to three-month intervals. Of the 109 hospitalized patients, 23 (21%) developed SBP, nine of which developed SBP during their hospitalization. The one-year cumulative probability of SBP in these patients with low ascitic fluid protein levels was 35%.
During this study, the authors also looked at 20 different patient variables on admission and found that two parameters—high bilirubin (>3.2mg/dL) and low platelet count (<98,000 cells/ul)—were associated with an increased risk of SBP. This is consistent with studies showing that patients with higher Model for End-Stage Liver Disease (MELD) or Child-Pugh scores, indicating more severe liver disease, are at increased risk for SBP. This likely is the reason SBP prophylaxis is recommended for patients with an elevated bilirubin, and higher Child-Pugh scores, by the American Association for the Study of Liver Disease (see Table 2, p. 41).
Runyon et al showed that 15% of patients with low ascitic fluid protein developed SBP during their hospitalization, as compared with 2% of patients with ascitic fluid levels greater than 1 g/dl.8 A randomized, non-placebo-controlled trial by Navasa et al evaluating 70 cirrhotic patients with low ascitic ascitic protein levels showed a lower probability of developing SBP in the group placed on SBP prophylaxis with norfloxacin (5% vs. 31%).9 Six-month mortality rate was also lower (19% vs. 36%).
In contrast to the previous studies, Grothe et al found that the presence of SBP was not related to ascitic protein content.10 Given conflicting studies, controversy still remains on whether patients with low ascitic protein should receive long-term prophylactic antibiotics.
Antibiotic Drawbacks
The consensus in the literature is that patients with ascites who are admitted with a GI bleed, or those with a history of SBP, should be placed on SBP prophylaxis. However, patients placed on long-term antibiotics are at risk for developing bacterial resistance. Bacterial resistance in cultures taken from cirrhotic patients with SBP has increased over the last decade, particularly in gram-negative bacteria.5 Patients who receive antibiotics in the pre-transplant setting also are at risk for post-transplant fungal infections.
Additionally, the antibiotic of choice for SBP prophylaxis is typically a fluoroquinolone, which can be expensive. However, numerous studies have shown that the cost of initiating prophylactic therapy for SBP in patients with a prior episode of SBP can be cheaper than treating SBP after diagnosis.2
Back to the Case
Our patient’s paracentesis was negative for SBP. Additionally, he does not have a history of SBP, nor does he have an active GI bleed. His only possible indication for SBP prophylaxis is low ascitic protein concentration. His electrolytes were all within normal limits. Additionally, total bilirubin was only slightly elevated at 2.3 mg/dL.
Based on the American Association for the Study of Liver Diseases guidelines, the patient was not started on SBP prophylaxis. Additionally, given his history of medication noncompliance, there is concern that he might not take the antibiotics as prescribed, thus leading to the development of bacterial resistance and more serious infections in the future.
Bottom Line
Patients with ascites and a prior episode of SBP, and those admitted to the hospital for GI bleeding, should be placed on SBP prophylaxis. SBP prophylaxis for low protein ascitic fluid remains controversial but is recommended by the American Association for the Study of Liver Diseases. TH
Dr. del Pino Jones is a hospitalist at the University of Colorado Denver.
References
- Ghassemi S, Garcia-Tsao G. Prevention and treatment of infections in patients with cirrhosis. Best Pract Res Clin Gastroenterol. 2007;21(1):77-93.
- Guarner C, Solà R, Soriono G, et al. Risk of a first community-acquired spontaneous bacterial peritonitis in cirrhotics with low ascitic fluid protein levels. Gastroenterology. 1999;117(2):414-419.
- Ginés P, Rimola A, Planas R, et al. Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: results of a double-blind, placebo-controlled trial. Hepatology. 1990;12(4 Pt 1):716-724.
- Rolachon A, Cordier L, Bacq Y, et al. Ciprofloxacin and long-term prevention of spontaneous bacterial peritonitis: results of a prospective controlled trial. Hepatology. 1995;22(4 Pt 1):1171-1174.
- Saab S, Hernandez J, Chi AC, Tong MJ. Oral antibiotic prophylaxis reduces spontaneous bacterial peritonitis occurrence and improves short-term survival in cirrhosis: a meta-analysis. Am J Gastroenterol. 2009;104(4):993-1001.
- Deschênes M, Villeneuve J. Risk factors for the development of bacterial infections in hospitalized patients with cirrhosis. Am J Gastroenterol. 1999;94(8):2193-2197.
- Bernard B, Grangé J, Khac EN, Amiot X, Opolon P, Poynard T. Antibiotic prophylaxis for the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding: a meta-analysis. Hepatology. 1999;29(6):1655-1661.
- Runyon B. Low-protein-concentration ascitic fluid is predisposed to spontaneous bacterial peritonitis. Gastroenterology. 1986;91(6):1343-1346.
- Navasa M, Fernandez J, Montoliu S, et al. Randomized, double-blind, placebo-controlled trial evaluating norfloxacin in the primary prophylaxis of spontaneous bacterial peritonitis in cirrhotics with renal impairment, hyponatremia or severe liver failure. J Hepatol. 2006;44(Supp2):S51.
- Grothe W, Lottere E, Fleig W. Factors predictive for spontaneous bacterial peritonitis (SBP) under routine inpatient conditions in patients with cirrhosis: a prospective multicenter trial. J Hepatol. 1990;34(4):547.
ONLINE EXCLUSIVE: Listen to HM experts discuss comanagement opportunities
Click here to listen to Dr. McKean
Click here to listen to Dr. Wachter
Click here to listen to Dr. Siegal
Click here to listen to Dr. Cheng
Click here to listen to Dr. Auerbach
Click here to listen to Dr. McKean
Click here to listen to Dr. Wachter
Click here to listen to Dr. Siegal
Click here to listen to Dr. Cheng
Click here to listen to Dr. Auerbach
Click here to listen to Dr. McKean
Click here to listen to Dr. Wachter
Click here to listen to Dr. Siegal
Click here to listen to Dr. Cheng
Click here to listen to Dr. Auerbach
ONLINE EXCLUSIVE: Listen to former Obama healthcare advisor Bob Kocher, MD
Click here to listen to Dr. Kocher
Click here to listen to Dr. Kocher
Click here to listen to Dr. Kocher
ONLINE EXCLUSIVE: Comanagement Business Models
One of the emerging trends in comanagement by hospitalists (see “The Comanagement Conundrum,” p. 1, April 2011) is an expanded role in the perioperative care of surgical patients—extending from before the operation into rehabilitation. To be successful, hospitalists should think more broadly than the usual focus on medical needs immediately post-surgery, says Burke Kealey, MD, director of perioperative comanagement at Regions Hospital in St. Paul, Minn.
The perioperative service at Regions includes staffing of a pre-operative clinic, a partnership with the hospital’s anesthesia department, and use of a pre-operative patient checklist. Many primary-care physicians (PCPs) want to retain a role in the pre-operative assessments of their patients, so the Regions service has tried to partner with physicians in the community to work on standardizing the process.
Dr. Kealey, an SHM board member, was hired by Regions’ orthopedic department right out of residency in 1995 to do medical comanagement of its patients. His service later was absorbed into an emerging HM department. It has experimented with models including the use of nurse practitioners and physician assistants.
—Burke Kealey, MD, director of perioperative comanagement, Regions Hospital, St. Paul, Minn., SHM board member
Today, Regions dedicates three of its 16 full-time hospitalist teams to comanagement services, largely on the orthopedics floor, but also for cardiovascular surgery and urology. “As hospitalists, we can help to facilitate using the best, up-to-date medical knowledge” both before and after surgery, he says.
At the University of Rochester School of Medicine in New York, a group of fellowship-trained geriatric hospitalists has taken on comanagement of hip fracture patients at the Geriatric Fracture Center, leading to improved processes and patient outcomes.1 According to hospitalist Susan M. Friedman, MD, MPH, the program began as a collaboration between a geriatrician and an orthopedic surgeon. They found that their patients’ outcomes seemed to be better when they worked together on a case, so they sat down to talk about what they were doing and how to standardize it.
“From the start, they set the tone for how this is supposed work, and when it doesn’t, they find out why and address it,” Dr. Friedman says. The program does not use a formal service agreement, but there is a strong emphasis on co-ownership, mutual respect, and communication. “One thing that has helped us a lot is data-gathering,” she adds. The hip fracture comanagement has cut lengths of stay and readmissions by half and complications by one-third for the mostly elderly patients.
Larry Beresford is a freelance writer based in Oakland, Calif.
Reference
- Friedman SM, Mendelson DA, Bingham KW, Kates SL. Impact of co-managed geriatric fracture center on short-term hip fracture outcomes. Arch Intern Med. 2009;169(18):1712-1717.
One of the emerging trends in comanagement by hospitalists (see “The Comanagement Conundrum,” p. 1, April 2011) is an expanded role in the perioperative care of surgical patients—extending from before the operation into rehabilitation. To be successful, hospitalists should think more broadly than the usual focus on medical needs immediately post-surgery, says Burke Kealey, MD, director of perioperative comanagement at Regions Hospital in St. Paul, Minn.
The perioperative service at Regions includes staffing of a pre-operative clinic, a partnership with the hospital’s anesthesia department, and use of a pre-operative patient checklist. Many primary-care physicians (PCPs) want to retain a role in the pre-operative assessments of their patients, so the Regions service has tried to partner with physicians in the community to work on standardizing the process.
Dr. Kealey, an SHM board member, was hired by Regions’ orthopedic department right out of residency in 1995 to do medical comanagement of its patients. His service later was absorbed into an emerging HM department. It has experimented with models including the use of nurse practitioners and physician assistants.
—Burke Kealey, MD, director of perioperative comanagement, Regions Hospital, St. Paul, Minn., SHM board member
Today, Regions dedicates three of its 16 full-time hospitalist teams to comanagement services, largely on the orthopedics floor, but also for cardiovascular surgery and urology. “As hospitalists, we can help to facilitate using the best, up-to-date medical knowledge” both before and after surgery, he says.
At the University of Rochester School of Medicine in New York, a group of fellowship-trained geriatric hospitalists has taken on comanagement of hip fracture patients at the Geriatric Fracture Center, leading to improved processes and patient outcomes.1 According to hospitalist Susan M. Friedman, MD, MPH, the program began as a collaboration between a geriatrician and an orthopedic surgeon. They found that their patients’ outcomes seemed to be better when they worked together on a case, so they sat down to talk about what they were doing and how to standardize it.
“From the start, they set the tone for how this is supposed work, and when it doesn’t, they find out why and address it,” Dr. Friedman says. The program does not use a formal service agreement, but there is a strong emphasis on co-ownership, mutual respect, and communication. “One thing that has helped us a lot is data-gathering,” she adds. The hip fracture comanagement has cut lengths of stay and readmissions by half and complications by one-third for the mostly elderly patients.
Larry Beresford is a freelance writer based in Oakland, Calif.
Reference
- Friedman SM, Mendelson DA, Bingham KW, Kates SL. Impact of co-managed geriatric fracture center on short-term hip fracture outcomes. Arch Intern Med. 2009;169(18):1712-1717.
One of the emerging trends in comanagement by hospitalists (see “The Comanagement Conundrum,” p. 1, April 2011) is an expanded role in the perioperative care of surgical patients—extending from before the operation into rehabilitation. To be successful, hospitalists should think more broadly than the usual focus on medical needs immediately post-surgery, says Burke Kealey, MD, director of perioperative comanagement at Regions Hospital in St. Paul, Minn.
The perioperative service at Regions includes staffing of a pre-operative clinic, a partnership with the hospital’s anesthesia department, and use of a pre-operative patient checklist. Many primary-care physicians (PCPs) want to retain a role in the pre-operative assessments of their patients, so the Regions service has tried to partner with physicians in the community to work on standardizing the process.
Dr. Kealey, an SHM board member, was hired by Regions’ orthopedic department right out of residency in 1995 to do medical comanagement of its patients. His service later was absorbed into an emerging HM department. It has experimented with models including the use of nurse practitioners and physician assistants.
—Burke Kealey, MD, director of perioperative comanagement, Regions Hospital, St. Paul, Minn., SHM board member
Today, Regions dedicates three of its 16 full-time hospitalist teams to comanagement services, largely on the orthopedics floor, but also for cardiovascular surgery and urology. “As hospitalists, we can help to facilitate using the best, up-to-date medical knowledge” both before and after surgery, he says.
At the University of Rochester School of Medicine in New York, a group of fellowship-trained geriatric hospitalists has taken on comanagement of hip fracture patients at the Geriatric Fracture Center, leading to improved processes and patient outcomes.1 According to hospitalist Susan M. Friedman, MD, MPH, the program began as a collaboration between a geriatrician and an orthopedic surgeon. They found that their patients’ outcomes seemed to be better when they worked together on a case, so they sat down to talk about what they were doing and how to standardize it.
“From the start, they set the tone for how this is supposed work, and when it doesn’t, they find out why and address it,” Dr. Friedman says. The program does not use a formal service agreement, but there is a strong emphasis on co-ownership, mutual respect, and communication. “One thing that has helped us a lot is data-gathering,” she adds. The hip fracture comanagement has cut lengths of stay and readmissions by half and complications by one-third for the mostly elderly patients.
Larry Beresford is a freelance writer based in Oakland, Calif.
Reference
- Friedman SM, Mendelson DA, Bingham KW, Kates SL. Impact of co-managed geriatric fracture center on short-term hip fracture outcomes. Arch Intern Med. 2009;169(18):1712-1717.
ONLINE EXCLUSIVE: Wachter Relishes Opportunity to Guide Hospitalists
Robert Wachter, MD, MHM, has spoken at SHM’s annual meeting every year since 2003.
The opportunity to address 2,500 physician leaders in clinical work, education, and quality improvement—and the chance to suggest where they should be placing their emphasis—is incredibly special, Dr. Wachter says.
“It’s an amazing chance to try to influence the fastest-growing specialty in history,” says the professor, chief of the Division of Hospital Medicine, and chief of the medical service at the University of California at San Francisco Medical Center.
“I like to think I have some small impact on the work they go out and do the next day, so it feels like a way of extending my own influence on this extraordinary field,” adds Dr. Wachter, a former SHM president and author of the blog Wachter’s World (www.wachtersworld.com). “That’s a great privilege.”
Dr. Wachter will speak at HM11 on Friday, May 13. The Hospitalist caught up with him to discuss some of his presentation.
Question: Why would you encourage hospitalists to attend HM11?
Answer: The content is great, and it is broad enough that it doesn’t matter whether you are coming to learn the latest ways to manage sepsis or the best ways to organize your program. We are able to attract the best leaders in the world to come speak, so the talent pool is unmatched. And the collegial exchange is fantastic. There’s as much important work that happens in the hallways as happens in the conference room.
Q: Bob Kocher, MD, a former special assistant to the president for healthcare and economic policy, will be a featured speaker this year. Why is it important for hospitalists to hear from him?
A: He was as important as any architect of the healthcare reform legislation. Because he left the White House, he can be open and honest about what’s working and not working. I think we need to understand what reform means, why it was organized the way it was, and where someone who was in the middle of that thinks it will go over time.
Q: What do you see as the legislation’s most significant impact on HM?
A: The dominant issue is, how do we create an environment, and a set of policy and payment initiatives, that incent and promote the delivery of the highest quality, safest, most satisfying care at the lowest cost? That’s not just within the silo we call a hospital but across the continuum of care. The bill takes that concept and puts it on steroids.
Robert Wachter, MD, MHM, has spoken at SHM’s annual meeting every year since 2003.
The opportunity to address 2,500 physician leaders in clinical work, education, and quality improvement—and the chance to suggest where they should be placing their emphasis—is incredibly special, Dr. Wachter says.
“It’s an amazing chance to try to influence the fastest-growing specialty in history,” says the professor, chief of the Division of Hospital Medicine, and chief of the medical service at the University of California at San Francisco Medical Center.
“I like to think I have some small impact on the work they go out and do the next day, so it feels like a way of extending my own influence on this extraordinary field,” adds Dr. Wachter, a former SHM president and author of the blog Wachter’s World (www.wachtersworld.com). “That’s a great privilege.”
Dr. Wachter will speak at HM11 on Friday, May 13. The Hospitalist caught up with him to discuss some of his presentation.
Question: Why would you encourage hospitalists to attend HM11?
Answer: The content is great, and it is broad enough that it doesn’t matter whether you are coming to learn the latest ways to manage sepsis or the best ways to organize your program. We are able to attract the best leaders in the world to come speak, so the talent pool is unmatched. And the collegial exchange is fantastic. There’s as much important work that happens in the hallways as happens in the conference room.
Q: Bob Kocher, MD, a former special assistant to the president for healthcare and economic policy, will be a featured speaker this year. Why is it important for hospitalists to hear from him?
A: He was as important as any architect of the healthcare reform legislation. Because he left the White House, he can be open and honest about what’s working and not working. I think we need to understand what reform means, why it was organized the way it was, and where someone who was in the middle of that thinks it will go over time.
Q: What do you see as the legislation’s most significant impact on HM?
A: The dominant issue is, how do we create an environment, and a set of policy and payment initiatives, that incent and promote the delivery of the highest quality, safest, most satisfying care at the lowest cost? That’s not just within the silo we call a hospital but across the continuum of care. The bill takes that concept and puts it on steroids.
Robert Wachter, MD, MHM, has spoken at SHM’s annual meeting every year since 2003.
The opportunity to address 2,500 physician leaders in clinical work, education, and quality improvement—and the chance to suggest where they should be placing their emphasis—is incredibly special, Dr. Wachter says.
“It’s an amazing chance to try to influence the fastest-growing specialty in history,” says the professor, chief of the Division of Hospital Medicine, and chief of the medical service at the University of California at San Francisco Medical Center.
“I like to think I have some small impact on the work they go out and do the next day, so it feels like a way of extending my own influence on this extraordinary field,” adds Dr. Wachter, a former SHM president and author of the blog Wachter’s World (www.wachtersworld.com). “That’s a great privilege.”
Dr. Wachter will speak at HM11 on Friday, May 13. The Hospitalist caught up with him to discuss some of his presentation.
Question: Why would you encourage hospitalists to attend HM11?
Answer: The content is great, and it is broad enough that it doesn’t matter whether you are coming to learn the latest ways to manage sepsis or the best ways to organize your program. We are able to attract the best leaders in the world to come speak, so the talent pool is unmatched. And the collegial exchange is fantastic. There’s as much important work that happens in the hallways as happens in the conference room.
Q: Bob Kocher, MD, a former special assistant to the president for healthcare and economic policy, will be a featured speaker this year. Why is it important for hospitalists to hear from him?
A: He was as important as any architect of the healthcare reform legislation. Because he left the White House, he can be open and honest about what’s working and not working. I think we need to understand what reform means, why it was organized the way it was, and where someone who was in the middle of that thinks it will go over time.
Q: What do you see as the legislation’s most significant impact on HM?
A: The dominant issue is, how do we create an environment, and a set of policy and payment initiatives, that incent and promote the delivery of the highest quality, safest, most satisfying care at the lowest cost? That’s not just within the silo we call a hospital but across the continuum of care. The bill takes that concept and puts it on steroids.