In his June 2009 address to the American Medical Association, President Obama commented that “doctors feel like they are constantly looking over their shoulder for fear of lawsuits. Some doctors may feel the need to order more tests and treatments to avoid being legally vulnerable.”¹ By practicing what the President called “excessive defensive medicine,” doctors provide “more treatment rather than better care” and drive up the cost of health care ( Box ).^2-7

This column takes a look at how defensive practices can make psychiatric care more costly and less effective, by answering these questions:

• What is defensive medicine?
• How much medical practice is “defensive,” and what does it cost?
• Do psychiatrists practice defensive medicine?
• Does defensive psychiatric practice lead to suboptimal care?
• Are some defensive practices justified?
• Can you balance good defense with good care?

What is defensive medicine?

In a 1994 study, the U.S. Office of Technology Assessment (OTA) said that defensive medicine occurs “when doctors order tests, procedures, or visits, or avoid high-risk patients or procedures, primarily (but not necessarily or solely) to reduce their exposure to malpractice liability.” This definition does not require that defensive clinical practices provide no benefit to patients, only that the expected benefits are small relative to their costs.⁸

Preventing the worst outcome

Studies suggest that doctors develop and maintain practice habits—consciously or not—that aim to reduce their risk of getting sued for malpractice. For example, when patients presenting with tick bites express concern about Lyme disease, doctors overuse tests and needlessly prescribe antibiotics.⁹ Although these practices are not evidence-based, they reduce doctors’ anxiety by “preventing the worst outcome at relatively little risk and cost and avoiding a potential lawsuit at the same time.”¹⁰

The OTA estimated that up to 8% of diagnostic procedures were ordered primarily because of conscious concern about malpractice liability, based on physicians’ responses to a set of written scenarios.⁸ In a recent study, 83% of Massachusetts physicians reported practicing defensive medicine and estimated that defensive reasons accounted for why they ordered:

• 18% of lab tests
• up to 30% of procedures and consultations
• 13% of hospitalizations.¹¹

Almost all high-liability specialists (such as emergency room physicians, surgeons, and obstetrician/gynecologists) report practicing defensive medicine, often gaging in “assurance behavior”—ordering tests, doing diagnostic procedures, and referring patients to consultants.¹²

Defensive psychiatry

Compared with other specialists, psychiatrists are at lower risk for being sued, but we engage in defensive practices nonetheless. A survey of British psychiatrists found that during the previous month, 75% made clinical decisions—such as “overcautiously” admitting patients or ordering special observation—because of worries about possible legal claims, complaints, or disciplinary action.¹³

Younger psychiatrists and psychiatrists who have experienced complaints and critical incidents are more likely to practice defensive medicine. This is hardly surprising—a malpractice suit can be very stressful.¹⁴ But an amorphous dread of lawsuits affects many psychiatrists, including residents who never have been sued. The result: many needless, countertherapeutic, defensive practices.^15,16

Unintended consequences

Defensive medicine is not just expensive and wasteful. It could increase your risk of litigation if practices result in harm.¹⁷ Simon and Shuman¹⁶ give examples of how attempts to avoid litigation can compromise clinical care when treating patients at risk for suicide:

• not prescribing clozapine—a treatment known to lower the risk of suicide¹⁸ —to a chronically suicidal patient with schizophrenia because of fears of agranulocytosis (see “Clozapine for schizophrenia: Life-threatening or life-saving treatment?” Current Psychiatry, December 2009)
• not recommending electroconvulsive therapy—and possibly prolonging the period when a severely depressed patient is at high risk for suicide—to avoid a lawsuit related to memory loss
• hospitalizing a patient at chronic risk for suicide who could be managed as an outpatient with appropriate safeguards, a practice that could undermine a valuable treatment alliance.

Good clinical care lowers the likelihood of harm to patients, making it a sound risk management practice, though not a complete strategy. Even the best doctors can start to think defensively when confronted with awkward, troubling, or life-threatening situations that could have medicolegal implications.¹⁶ For example, when an outpatient threatens to hurt someone else, it may be tempting to just confine him in a hospital (which reduces the doctor’s anxiety) even when other less coercive and more therapeutic options might better resolve the patient’s problems and the risk of violence.

Recognizing that you’re making clinical decisions out of fear of getting sued is the first step toward curtailing needlessly defensive practice. See Table ¹⁹ for more strategies.

Table

3 strategies for avoiding needless defensive medicine

Justifiable defensiveness

Of course, it’s perfectly appropriate for psychiatrists to recognize malpractice risks and take appropriate measures to avoid successful lawsuits. For example, thoughtful documentation of your data gathering, decision making, and informed consent is an appropriate protective practice. Usually, no one sees the documentation, and it contributes little to your patients’ well-being. Good documentation can be inexpensive, however, and if done creatively, can improve data recording that in turn contributes to better treatment.²⁰

In his June 2009 address to the American Medical Association, President Obama commented that “doctors feel like they are constantly looking over their shoulder for fear of lawsuits. Some doctors may feel the need to order more tests and treatments to avoid being legally vulnerable.”¹ By practicing what the President called “excessive defensive medicine,” doctors provide “more treatment rather than better care” and drive up the cost of health care ( Box ).^2-7

This column takes a look at how defensive practices can make psychiatric care more costly and less effective, by answering these questions:

• What is defensive medicine?
• How much medical practice is “defensive,” and what does it cost?
• Do psychiatrists practice defensive medicine?
• Does defensive psychiatric practice lead to suboptimal care?
• Are some defensive practices justified?
• Can you balance good defense with good care?

What is defensive medicine?

In a 1994 study, the U.S. Office of Technology Assessment (OTA) said that defensive medicine occurs “when doctors order tests, procedures, or visits, or avoid high-risk patients or procedures, primarily (but not necessarily or solely) to reduce their exposure to malpractice liability.” This definition does not require that defensive clinical practices provide no benefit to patients, only that the expected benefits are small relative to their costs.⁸

Preventing the worst outcome

Studies suggest that doctors develop and maintain practice habits—consciously or not—that aim to reduce their risk of getting sued for malpractice. For example, when patients presenting with tick bites express concern about Lyme disease, doctors overuse tests and needlessly prescribe antibiotics.⁹ Although these practices are not evidence-based, they reduce doctors’ anxiety by “preventing the worst outcome at relatively little risk and cost and avoiding a potential lawsuit at the same time.”¹⁰

The OTA estimated that up to 8% of diagnostic procedures were ordered primarily because of conscious concern about malpractice liability, based on physicians’ responses to a set of written scenarios.⁸ In a recent study, 83% of Massachusetts physicians reported practicing defensive medicine and estimated that defensive reasons accounted for why they ordered:

• 18% of lab tests
• up to 30% of procedures and consultations
• 13% of hospitalizations.¹¹

Almost all high-liability specialists (such as emergency room physicians, surgeons, and obstetrician/gynecologists) report practicing defensive medicine, often gaging in “assurance behavior”—ordering tests, doing diagnostic procedures, and referring patients to consultants.¹²

Defensive psychiatry

Compared with other specialists, psychiatrists are at lower risk for being sued, but we engage in defensive practices nonetheless. A survey of British psychiatrists found that during the previous month, 75% made clinical decisions—such as “overcautiously” admitting patients or ordering special observation—because of worries about possible legal claims, complaints, or disciplinary action.¹³

Younger psychiatrists and psychiatrists who have experienced complaints and critical incidents are more likely to practice defensive medicine. This is hardly surprising—a malpractice suit can be very stressful.¹⁴ But an amorphous dread of lawsuits affects many psychiatrists, including residents who never have been sued. The result: many needless, countertherapeutic, defensive practices.^15,16

Unintended consequences

Defensive medicine is not just expensive and wasteful. It could increase your risk of litigation if practices result in harm.¹⁷ Simon and Shuman¹⁶ give examples of how attempts to avoid litigation can compromise clinical care when treating patients at risk for suicide:

• not prescribing clozapine—a treatment known to lower the risk of suicide¹⁸ —to a chronically suicidal patient with schizophrenia because of fears of agranulocytosis (see “Clozapine for schizophrenia: Life-threatening or life-saving treatment?” Current Psychiatry, December 2009)
• not recommending electroconvulsive therapy—and possibly prolonging the period when a severely depressed patient is at high risk for suicide—to avoid a lawsuit related to memory loss
• hospitalizing a patient at chronic risk for suicide who could be managed as an outpatient with appropriate safeguards, a practice that could undermine a valuable treatment alliance.

Good clinical care lowers the likelihood of harm to patients, making it a sound risk management practice, though not a complete strategy. Even the best doctors can start to think defensively when confronted with awkward, troubling, or life-threatening situations that could have medicolegal implications.¹⁶ For example, when an outpatient threatens to hurt someone else, it may be tempting to just confine him in a hospital (which reduces the doctor’s anxiety) even when other less coercive and more therapeutic options might better resolve the patient’s problems and the risk of violence.

Recognizing that you’re making clinical decisions out of fear of getting sued is the first step toward curtailing needlessly defensive practice. See Table ¹⁹ for more strategies.

Table

3 strategies for avoiding needless defensive medicine

Justifiable defensiveness

Of course, it’s perfectly appropriate for psychiatrists to recognize malpractice risks and take appropriate measures to avoid successful lawsuits. For example, thoughtful documentation of your data gathering, decision making, and informed consent is an appropriate protective practice. Usually, no one sees the documentation, and it contributes little to your patients’ well-being. Good documentation can be inexpensive, however, and if done creatively, can improve data recording that in turn contributes to better treatment.²⁰

In his June 2009 address to the American Medical Association, President Obama commented that “doctors feel like they are constantly looking over their shoulder for fear of lawsuits. Some doctors may feel the need to order more tests and treatments to avoid being legally vulnerable.”¹ By practicing what the President called “excessive defensive medicine,” doctors provide “more treatment rather than better care” and drive up the cost of health care ( Box ).^2-7

This column takes a look at how defensive practices can make psychiatric care more costly and less effective, by answering these questions:

• What is defensive medicine?
• How much medical practice is “defensive,” and what does it cost?
• Do psychiatrists practice defensive medicine?
• Does defensive psychiatric practice lead to suboptimal care?
• Are some defensive practices justified?
• Can you balance good defense with good care?

What is defensive medicine?

In a 1994 study, the U.S. Office of Technology Assessment (OTA) said that defensive medicine occurs “when doctors order tests, procedures, or visits, or avoid high-risk patients or procedures, primarily (but not necessarily or solely) to reduce their exposure to malpractice liability.” This definition does not require that defensive clinical practices provide no benefit to patients, only that the expected benefits are small relative to their costs.⁸

Preventing the worst outcome

Studies suggest that doctors develop and maintain practice habits—consciously or not—that aim to reduce their risk of getting sued for malpractice. For example, when patients presenting with tick bites express concern about Lyme disease, doctors overuse tests and needlessly prescribe antibiotics.⁹ Although these practices are not evidence-based, they reduce doctors’ anxiety by “preventing the worst outcome at relatively little risk and cost and avoiding a potential lawsuit at the same time.”¹⁰

The OTA estimated that up to 8% of diagnostic procedures were ordered primarily because of conscious concern about malpractice liability, based on physicians’ responses to a set of written scenarios.⁸ In a recent study, 83% of Massachusetts physicians reported practicing defensive medicine and estimated that defensive reasons accounted for why they ordered:

• 18% of lab tests
• up to 30% of procedures and consultations
• 13% of hospitalizations.¹¹

Almost all high-liability specialists (such as emergency room physicians, surgeons, and obstetrician/gynecologists) report practicing defensive medicine, often gaging in “assurance behavior”—ordering tests, doing diagnostic procedures, and referring patients to consultants.¹²

Defensive psychiatry

Compared with other specialists, psychiatrists are at lower risk for being sued, but we engage in defensive practices nonetheless. A survey of British psychiatrists found that during the previous month, 75% made clinical decisions—such as “overcautiously” admitting patients or ordering special observation—because of worries about possible legal claims, complaints, or disciplinary action.¹³

Younger psychiatrists and psychiatrists who have experienced complaints and critical incidents are more likely to practice defensive medicine. This is hardly surprising—a malpractice suit can be very stressful.¹⁴ But an amorphous dread of lawsuits affects many psychiatrists, including residents who never have been sued. The result: many needless, countertherapeutic, defensive practices.^15,16

Unintended consequences

Defensive medicine is not just expensive and wasteful. It could increase your risk of litigation if practices result in harm.¹⁷ Simon and Shuman¹⁶ give examples of how attempts to avoid litigation can compromise clinical care when treating patients at risk for suicide:

• not prescribing clozapine—a treatment known to lower the risk of suicide¹⁸ —to a chronically suicidal patient with schizophrenia because of fears of agranulocytosis (see “Clozapine for schizophrenia: Life-threatening or life-saving treatment?” Current Psychiatry, December 2009)
• not recommending electroconvulsive therapy—and possibly prolonging the period when a severely depressed patient is at high risk for suicide—to avoid a lawsuit related to memory loss
• hospitalizing a patient at chronic risk for suicide who could be managed as an outpatient with appropriate safeguards, a practice that could undermine a valuable treatment alliance.

Good clinical care lowers the likelihood of harm to patients, making it a sound risk management practice, though not a complete strategy. Even the best doctors can start to think defensively when confronted with awkward, troubling, or life-threatening situations that could have medicolegal implications.¹⁶ For example, when an outpatient threatens to hurt someone else, it may be tempting to just confine him in a hospital (which reduces the doctor’s anxiety) even when other less coercive and more therapeutic options might better resolve the patient’s problems and the risk of violence.

Recognizing that you’re making clinical decisions out of fear of getting sued is the first step toward curtailing needlessly defensive practice. See Table ¹⁹ for more strategies.

Table

3 strategies for avoiding needless defensive medicine

Justifiable defensiveness

Of course, it’s perfectly appropriate for psychiatrists to recognize malpractice risks and take appropriate measures to avoid successful lawsuits. For example, thoughtful documentation of your data gathering, decision making, and informed consent is an appropriate protective practice. Usually, no one sees the documentation, and it contributes little to your patients’ well-being. Good documentation can be inexpensive, however, and if done creatively, can improve data recording that in turn contributes to better treatment.²⁰

Discuss this article

Mr. A, age 45, reports irritability, loss of interest, sleep disturbance, increased self-criticism, and decreased self care during the last month after a promotion at work. He has a history of 3 major depressive episodes, 1 of which required hospitalization. For the last 2 years his depressive symptoms had been successfully managed with escitalopram, 10 mg/d, plus bupropion, 150 mg/d. Mr. A wants to discontinue these medications because of sexual dysfunction. He asks if nonpharmacologic strategies might help.

One option to consider for Mr. A is mindfulness-based cognitive therapy (MBCT), which was originally developed to help prevent depressive relapse. MBCT also can reduce depression and anxiety symptoms. More recently, MBCT was shown to help individuals discontinue antidepressants after recovering from depression.

Regular mindfulness meditation has been shown to result in structural brain changes that may help explain how the practice effectively addresses psychiatric symptoms ( Box ). With appropriate training, psychiatrists can help patients reap the benefits of this cognitive treatment.

Box

What is mindfulness meditation?

Meditation refers to a variety of practices that intentionally focus attention to help the practitioner disengage from unconscious absorption in thoughts and feelings. Unlike concentrative meditation—in which practitioners focus attention on a single object such as a word (mantra), body part, or external object—in mindfulness meditation participants bring their attention to a wide range of objects (such as breath, body, emotions, or thoughts) as they appear in moment-by-moment awareness.

Mindfulness is a nonjudgmental, present-centered awareness in which each thought, feeling, or sensation that arises in the attentional field is acknowledged and accepted as it is.^1-3 Bishop et al⁴ defined a 2-component model of mindfulness:

• self-regulating attention of immediate experience, thereby allowing for increased recognition of mental events in the present moment
• adopting an orientation of curiosity, openness, and acceptance toward one’s experiences in each moment.

Mindfulness-based interventions

Buddhist and Western psychology inform the theoretical framework of most mindfulness-based clinical interventions, such as:

• acceptance and commitment therapy (ACT)
• dialectical behavioral therapy (DBT)
• mindfulness-based stress reduction (MBSR)
• MBCT.

Because mindfulness is only 1 of several components of ACT and DBT,⁵ this review focuses on MBCT and MBSR, in which teaching mindfulness skills is the central focus of treatment.

MBCT and MBSR. MBCT incorporates many aspects of the manualized MBSR treatment program developed for managing chronic pain.^6,7 MBSR is devoted almost entirely to cultivating mindfulness through:

• formal mindfulness meditation practices such as body scan (intentionally bringing awareness to bodily sensations), mindful stretching, and mindfulness of breath/body/sounds/thoughts
• informal practices, including mindfulness of daily activities such as eating.¹

MBSR typically involves 8 to 10 weekly group sessions of 2 to 2.5 hours with 10 to 40 participants with heterogeneous or homogenous clinical presentations. At each session, patients are taught mindfulness skills and practices. Typically, a full day of meditation practice on a weekend follows session 5 or 6. Participants also engage in a daily meditation practice and homework exercises directed at integrating awareness skills into daily life.

Meta-analytic and narrative reviews generally support MBSR’s efficacy for a wide range of clinical presentations, including improved quality of life for chronic pain and cancer patients.^5,8-11 Variability in the methodologic rigor of clinical trials of mindfulness-based interventions—such as lack of active control groups and small sample sizes—limits the strength of these studies’ conclusions, however.⁸

MBCT integrates the mindfulness training of MBSR with cognitive therapy techniques ( Table 1 ) to prevent the consolidation of ruminative, negative thinking patterns that contribute to depressive relapse.² These cognitive therapy techniques include:

• psychoeducation about depression symptoms and automatic thoughts
• exercises designed to demonstrate the cognitive model
• identifying activities that provide feelings of mastery and/or pleasure
• creating a specific relapse prevention plan.

In addition, MBCT introduces a new informal meditation—the 3-minute breathing space—to facilitate present-moment awareness in upsetting everyday situations.

Evidence supporting MBCT comes from randomized, controlled trials (RCTs) and uncontrolled trials ( Table 2 ).^12-18 A systematic review of RCTs supported using MBCT in addition to usual care to prevent depressive relapse in individuals with a history of ≥3 depressive episodes.¹⁹ Since that review was published, a large RCT (123 patients) comparing antidepressant medication alone to antidepressants plus adjunctive MBCT with support to taper/discontinue antidepressant therapy found:

• MBCT comparable to maintenance antidepressant medication in preventing depressive relapse for individuals with ≥3 depressive episodes
• no difference in cost between these 2 treatments.¹²

In this study, MBCT was more effective than maintenance pharmacotherapy in reducing residual depressive symptoms and in improving quality of life; 75% in the MBCT group discontinued antidepressants. MBCT is included in the United Kingdom’s National Institute for Clinical Excellence Clinical Practice Guidelines for Depression²⁰ for prevention of recurrent depression.

RCTs and uncontrolled studies have shown that MBCT reduces depressive and anxious symptoms in individuals suffering from mood disorders. In an open-label pilot study of MBCT’s efficacy in reducing depressive symptoms in patients with treatment-resistant depression and ≥3 depressive episodes, 61% of patients achieved a post-MBCT Beck Depression Inventory-II (BDI-II) score <14, which represents normal or near-normal mood (mean BDI-II scores decreased from 24.3 to 13.9; effect size 1.04).¹⁷

Mindfulness for other psychiatric conditions. A review by Toneatto and Nguyen²¹ of MBSR in the treatment of anxiety and depression symptoms in a range of clinical populations concluded that the evidence supporting a beneficial effect was equivocal. On the other hand, several uncontrolled studies and 1 RCT indicate that mindfulness-based treatments can reduce symptoms in other psychiatric conditions, including eating disorders,²² generalized anxiety disorder,²³ bipolar disorder,²⁴ and attention-deficit/hyperactivity disorder.²⁵ Many of these studies were developed to target mood and anxiety symptoms by linking mindfulness and symptom management; this differs from MBSR, which focuses on stress reduction. Methodologically rigorous studies are necessary to evaluate mindfulness-based treatments in these and other psychiatric conditions.

Table 1

Skills and practices taught in mindfulness training

Table 2

Evidence of reduced depressive symptoms, anxiety with MBCT

CASE CONTINUED: Explaining the potential benefits

You inform Mr. A that MBCT has been shown to improve acute mild-to-moderate depressive symptoms, may decrease his risk of depressive relapse by 50%²⁶ and could help him discontinue his medications.¹² He asks how mindfulness exercises will help his symptoms.

How mindfulness works

The assumption that increased mindfulness mediates treatment outcomes⁴ has been addressed systematically only recently, following the development of operational definitions of mindfulness and self-report mindfulness measures, including the:

• Mindful Attention Awareness Scale (MAAS)²⁷
• Five Facet Mindfulness Questionnaire (FFMQ)¹²
• Toronto Mindfulness Scale (TMS).²⁸

Uncontrolled studies using these measures demonstrated that self-reported mindfulness increased following MBSR^28,29 and MBCT^15,18 in individuals with general stress, anxiety disorder or primary depression, cancer, chronic pain disorder, diabetes, and multiple sclerosis. Accumulating evidence from 1 RCT³⁰ and 2 other uncontrolled studies^28,31 demonstrates that mindfulness is associated with symptom reduction following MBSR.

Researchers have begun to focus on how mindfulness skills reduce symptoms. Baer⁹ proposed several mechanisms, including:

• cognitive change
• improved self-management
• exposure to painful experiences leading to reduced emotional reactivity.

Cognitive change—also called meta-cognitive awareness—is the development of a “distanced “or “decentered” perspective in which patients experience their thoughts and feelings as “mental events” rather than as true, accurate versions of reality. This is thought to introduce a “space” between perception and response that enables patients to have a reflective—rather than a reflexive or reactive—response to situations, which in turn reduces vulnerability to psychological processes that contribute to emotional suffering. Some preliminary evidence suggests that MBCT-associated increases in metacognitive awareness reduce risk of depressive relapse.³²

Teaching mindfulness

Guidelines for psychiatrists who wish to become MBCT instructors suggest undergoing formal teacher development training, attending a 7- to 10-day meditation retreat, and establishing your own daily mindfulness practice ( Table 3 ).³³ Segal et al² also recommend recognized training in counseling, psychotherapy, or as a mental health professional, as well as training in cognitive therapy and having experience leading psychotherapy groups.

The recommendation that a mindfulness teacher should practice meditation derives from the view that instructors teach from their own meditation experience and embody the attitudes they invite participants to practice. In an RCT, patients of psychotherapists in training (PiTs) who practiced meditation had greater symptom reductions than those of PiTs who did not engage in meditation.³⁴

To cultivate your own mindfulness practice, consider enrolling in an MBSR group, participating in an MBCT training retreat (see Related Resources ), or attending a mindfulness meditation retreat.

Although patient access to MBCT and MBSR programs has been increasing, formal MBSR/MBCT group programs led by trained therapists are limited. Patients can go through an MBSR/MBCT book with a trained clinician or listen to audio recordings with guided meditation instructions. Alternately, they can join a meditation sitting group or an insight meditation correspondence course ( Table 4 ).

Table 3

Recommended process for becoming an MBCT instructor

Table 4

Useful mindfulness resources for interested patients

CASE CONTINUED: Daily mindfulness practice

Mr. A enrolls in and completes a group MBCT program. He rearranges his schedule to include 30 minutes of formal mindfulness practice daily. During an office visit after completing the MBCT course, he describes decreased irritability and self-criticism, newfound self-acceptance, an increased ability to tolerate previously distressing affect, and the ability to set realistic expectations of himself, particularly in light of increased responsibilities at work. He also reports an increased sense of engagement in and reward in his personal life.

Several months later he requests and successfully completes an antidepressant taper and has no recurrence of depressive episodes at 18-month follow-up. He participates in monthly meditation groups to support his home practice.

Related resources

• Germer CK, Siegel R, Fulton PR, eds. Mindfulness and psychotherapy. New York, NY: Guilford Press; 2005.
• Mindfulness-based cognitive therapy. www.mbct.com; www.mbct.co.uk; www.bangor.ac.uk/mindfulness.
• Center for Mindfulness in Medicine, Health Care, and Society. www.umassmed.edu/cfm.
• Neurobiology of mindfulness. www.mindfulness-matters.org.
• Siegel DJ. The mindful brain: reflection and attunement in the cultivation of well-being. New York, NY: Norton; 2007.
• University of California, San Diego Center for Mindfulness. http://cme.ucsd.edu/mindfulness.

Drug brand names

• Bupropion • Wellbutrin
• Escitalopram • Lexapro

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Acknowledgment

The authors would like to thank Amanda Yu for her assistance in preparing the manuscript.

Discuss this article

Mr. A, age 45, reports irritability, loss of interest, sleep disturbance, increased self-criticism, and decreased self care during the last month after a promotion at work. He has a history of 3 major depressive episodes, 1 of which required hospitalization. For the last 2 years his depressive symptoms had been successfully managed with escitalopram, 10 mg/d, plus bupropion, 150 mg/d. Mr. A wants to discontinue these medications because of sexual dysfunction. He asks if nonpharmacologic strategies might help.

One option to consider for Mr. A is mindfulness-based cognitive therapy (MBCT), which was originally developed to help prevent depressive relapse. MBCT also can reduce depression and anxiety symptoms. More recently, MBCT was shown to help individuals discontinue antidepressants after recovering from depression.

Regular mindfulness meditation has been shown to result in structural brain changes that may help explain how the practice effectively addresses psychiatric symptoms ( Box ). With appropriate training, psychiatrists can help patients reap the benefits of this cognitive treatment.

Box

What is mindfulness meditation?

Meditation refers to a variety of practices that intentionally focus attention to help the practitioner disengage from unconscious absorption in thoughts and feelings. Unlike concentrative meditation—in which practitioners focus attention on a single object such as a word (mantra), body part, or external object—in mindfulness meditation participants bring their attention to a wide range of objects (such as breath, body, emotions, or thoughts) as they appear in moment-by-moment awareness.

Mindfulness is a nonjudgmental, present-centered awareness in which each thought, feeling, or sensation that arises in the attentional field is acknowledged and accepted as it is.^1-3 Bishop et al⁴ defined a 2-component model of mindfulness:

• self-regulating attention of immediate experience, thereby allowing for increased recognition of mental events in the present moment
• adopting an orientation of curiosity, openness, and acceptance toward one’s experiences in each moment.

Mindfulness-based interventions

Buddhist and Western psychology inform the theoretical framework of most mindfulness-based clinical interventions, such as:

• acceptance and commitment therapy (ACT)
• dialectical behavioral therapy (DBT)
• mindfulness-based stress reduction (MBSR)
• MBCT.

Because mindfulness is only 1 of several components of ACT and DBT,⁵ this review focuses on MBCT and MBSR, in which teaching mindfulness skills is the central focus of treatment.

MBCT and MBSR. MBCT incorporates many aspects of the manualized MBSR treatment program developed for managing chronic pain.^6,7 MBSR is devoted almost entirely to cultivating mindfulness through:

• formal mindfulness meditation practices such as body scan (intentionally bringing awareness to bodily sensations), mindful stretching, and mindfulness of breath/body/sounds/thoughts
• informal practices, including mindfulness of daily activities such as eating.¹

MBSR typically involves 8 to 10 weekly group sessions of 2 to 2.5 hours with 10 to 40 participants with heterogeneous or homogenous clinical presentations. At each session, patients are taught mindfulness skills and practices. Typically, a full day of meditation practice on a weekend follows session 5 or 6. Participants also engage in a daily meditation practice and homework exercises directed at integrating awareness skills into daily life.

Meta-analytic and narrative reviews generally support MBSR’s efficacy for a wide range of clinical presentations, including improved quality of life for chronic pain and cancer patients.^5,8-11 Variability in the methodologic rigor of clinical trials of mindfulness-based interventions—such as lack of active control groups and small sample sizes—limits the strength of these studies’ conclusions, however.⁸

MBCT integrates the mindfulness training of MBSR with cognitive therapy techniques ( Table 1 ) to prevent the consolidation of ruminative, negative thinking patterns that contribute to depressive relapse.² These cognitive therapy techniques include:

• psychoeducation about depression symptoms and automatic thoughts
• exercises designed to demonstrate the cognitive model
• identifying activities that provide feelings of mastery and/or pleasure
• creating a specific relapse prevention plan.

In addition, MBCT introduces a new informal meditation—the 3-minute breathing space—to facilitate present-moment awareness in upsetting everyday situations.

Evidence supporting MBCT comes from randomized, controlled trials (RCTs) and uncontrolled trials ( Table 2 ).^12-18 A systematic review of RCTs supported using MBCT in addition to usual care to prevent depressive relapse in individuals with a history of ≥3 depressive episodes.¹⁹ Since that review was published, a large RCT (123 patients) comparing antidepressant medication alone to antidepressants plus adjunctive MBCT with support to taper/discontinue antidepressant therapy found:

• MBCT comparable to maintenance antidepressant medication in preventing depressive relapse for individuals with ≥3 depressive episodes
• no difference in cost between these 2 treatments.¹²

In this study, MBCT was more effective than maintenance pharmacotherapy in reducing residual depressive symptoms and in improving quality of life; 75% in the MBCT group discontinued antidepressants. MBCT is included in the United Kingdom’s National Institute for Clinical Excellence Clinical Practice Guidelines for Depression²⁰ for prevention of recurrent depression.

RCTs and uncontrolled studies have shown that MBCT reduces depressive and anxious symptoms in individuals suffering from mood disorders. In an open-label pilot study of MBCT’s efficacy in reducing depressive symptoms in patients with treatment-resistant depression and ≥3 depressive episodes, 61% of patients achieved a post-MBCT Beck Depression Inventory-II (BDI-II) score <14, which represents normal or near-normal mood (mean BDI-II scores decreased from 24.3 to 13.9; effect size 1.04).¹⁷

Mindfulness for other psychiatric conditions. A review by Toneatto and Nguyen²¹ of MBSR in the treatment of anxiety and depression symptoms in a range of clinical populations concluded that the evidence supporting a beneficial effect was equivocal. On the other hand, several uncontrolled studies and 1 RCT indicate that mindfulness-based treatments can reduce symptoms in other psychiatric conditions, including eating disorders,²² generalized anxiety disorder,²³ bipolar disorder,²⁴ and attention-deficit/hyperactivity disorder.²⁵ Many of these studies were developed to target mood and anxiety symptoms by linking mindfulness and symptom management; this differs from MBSR, which focuses on stress reduction. Methodologically rigorous studies are necessary to evaluate mindfulness-based treatments in these and other psychiatric conditions.

Table 1

Skills and practices taught in mindfulness training

Table 2

Evidence of reduced depressive symptoms, anxiety with MBCT

CASE CONTINUED: Explaining the potential benefits

You inform Mr. A that MBCT has been shown to improve acute mild-to-moderate depressive symptoms, may decrease his risk of depressive relapse by 50%²⁶ and could help him discontinue his medications.¹² He asks how mindfulness exercises will help his symptoms.

How mindfulness works

The assumption that increased mindfulness mediates treatment outcomes⁴ has been addressed systematically only recently, following the development of operational definitions of mindfulness and self-report mindfulness measures, including the:

• Mindful Attention Awareness Scale (MAAS)²⁷
• Five Facet Mindfulness Questionnaire (FFMQ)¹²
• Toronto Mindfulness Scale (TMS).²⁸

Uncontrolled studies using these measures demonstrated that self-reported mindfulness increased following MBSR^28,29 and MBCT^15,18 in individuals with general stress, anxiety disorder or primary depression, cancer, chronic pain disorder, diabetes, and multiple sclerosis. Accumulating evidence from 1 RCT³⁰ and 2 other uncontrolled studies^28,31 demonstrates that mindfulness is associated with symptom reduction following MBSR.

Researchers have begun to focus on how mindfulness skills reduce symptoms. Baer⁹ proposed several mechanisms, including:

• cognitive change
• improved self-management
• exposure to painful experiences leading to reduced emotional reactivity.

Cognitive change—also called meta-cognitive awareness—is the development of a “distanced “or “decentered” perspective in which patients experience their thoughts and feelings as “mental events” rather than as true, accurate versions of reality. This is thought to introduce a “space” between perception and response that enables patients to have a reflective—rather than a reflexive or reactive—response to situations, which in turn reduces vulnerability to psychological processes that contribute to emotional suffering. Some preliminary evidence suggests that MBCT-associated increases in metacognitive awareness reduce risk of depressive relapse.³²

Teaching mindfulness

Guidelines for psychiatrists who wish to become MBCT instructors suggest undergoing formal teacher development training, attending a 7- to 10-day meditation retreat, and establishing your own daily mindfulness practice ( Table 3 ).³³ Segal et al² also recommend recognized training in counseling, psychotherapy, or as a mental health professional, as well as training in cognitive therapy and having experience leading psychotherapy groups.

The recommendation that a mindfulness teacher should practice meditation derives from the view that instructors teach from their own meditation experience and embody the attitudes they invite participants to practice. In an RCT, patients of psychotherapists in training (PiTs) who practiced meditation had greater symptom reductions than those of PiTs who did not engage in meditation.³⁴

To cultivate your own mindfulness practice, consider enrolling in an MBSR group, participating in an MBCT training retreat (see Related Resources ), or attending a mindfulness meditation retreat.

Although patient access to MBCT and MBSR programs has been increasing, formal MBSR/MBCT group programs led by trained therapists are limited. Patients can go through an MBSR/MBCT book with a trained clinician or listen to audio recordings with guided meditation instructions. Alternately, they can join a meditation sitting group or an insight meditation correspondence course ( Table 4 ).

Table 3

Recommended process for becoming an MBCT instructor

Table 4

Useful mindfulness resources for interested patients

CASE CONTINUED: Daily mindfulness practice

Mr. A enrolls in and completes a group MBCT program. He rearranges his schedule to include 30 minutes of formal mindfulness practice daily. During an office visit after completing the MBCT course, he describes decreased irritability and self-criticism, newfound self-acceptance, an increased ability to tolerate previously distressing affect, and the ability to set realistic expectations of himself, particularly in light of increased responsibilities at work. He also reports an increased sense of engagement in and reward in his personal life.

Several months later he requests and successfully completes an antidepressant taper and has no recurrence of depressive episodes at 18-month follow-up. He participates in monthly meditation groups to support his home practice.

Related resources

• Germer CK, Siegel R, Fulton PR, eds. Mindfulness and psychotherapy. New York, NY: Guilford Press; 2005.
• Mindfulness-based cognitive therapy. www.mbct.com; www.mbct.co.uk; www.bangor.ac.uk/mindfulness.
• Center for Mindfulness in Medicine, Health Care, and Society. www.umassmed.edu/cfm.
• Neurobiology of mindfulness. www.mindfulness-matters.org.
• Siegel DJ. The mindful brain: reflection and attunement in the cultivation of well-being. New York, NY: Norton; 2007.
• University of California, San Diego Center for Mindfulness. http://cme.ucsd.edu/mindfulness.

Drug brand names

• Bupropion • Wellbutrin
• Escitalopram • Lexapro

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Acknowledgment

The authors would like to thank Amanda Yu for her assistance in preparing the manuscript.

Discuss this article

Mr. A, age 45, reports irritability, loss of interest, sleep disturbance, increased self-criticism, and decreased self care during the last month after a promotion at work. He has a history of 3 major depressive episodes, 1 of which required hospitalization. For the last 2 years his depressive symptoms had been successfully managed with escitalopram, 10 mg/d, plus bupropion, 150 mg/d. Mr. A wants to discontinue these medications because of sexual dysfunction. He asks if nonpharmacologic strategies might help.

One option to consider for Mr. A is mindfulness-based cognitive therapy (MBCT), which was originally developed to help prevent depressive relapse. MBCT also can reduce depression and anxiety symptoms. More recently, MBCT was shown to help individuals discontinue antidepressants after recovering from depression.

Regular mindfulness meditation has been shown to result in structural brain changes that may help explain how the practice effectively addresses psychiatric symptoms ( Box ). With appropriate training, psychiatrists can help patients reap the benefits of this cognitive treatment.

Box

What is mindfulness meditation?

Meditation refers to a variety of practices that intentionally focus attention to help the practitioner disengage from unconscious absorption in thoughts and feelings. Unlike concentrative meditation—in which practitioners focus attention on a single object such as a word (mantra), body part, or external object—in mindfulness meditation participants bring their attention to a wide range of objects (such as breath, body, emotions, or thoughts) as they appear in moment-by-moment awareness.

Mindfulness is a nonjudgmental, present-centered awareness in which each thought, feeling, or sensation that arises in the attentional field is acknowledged and accepted as it is.^1-3 Bishop et al⁴ defined a 2-component model of mindfulness:

• self-regulating attention of immediate experience, thereby allowing for increased recognition of mental events in the present moment
• adopting an orientation of curiosity, openness, and acceptance toward one’s experiences in each moment.

Mindfulness-based interventions

Buddhist and Western psychology inform the theoretical framework of most mindfulness-based clinical interventions, such as:

• acceptance and commitment therapy (ACT)
• dialectical behavioral therapy (DBT)
• mindfulness-based stress reduction (MBSR)
• MBCT.

Because mindfulness is only 1 of several components of ACT and DBT,⁵ this review focuses on MBCT and MBSR, in which teaching mindfulness skills is the central focus of treatment.

MBCT and MBSR. MBCT incorporates many aspects of the manualized MBSR treatment program developed for managing chronic pain.^6,7 MBSR is devoted almost entirely to cultivating mindfulness through:

• formal mindfulness meditation practices such as body scan (intentionally bringing awareness to bodily sensations), mindful stretching, and mindfulness of breath/body/sounds/thoughts
• informal practices, including mindfulness of daily activities such as eating.¹

MBSR typically involves 8 to 10 weekly group sessions of 2 to 2.5 hours with 10 to 40 participants with heterogeneous or homogenous clinical presentations. At each session, patients are taught mindfulness skills and practices. Typically, a full day of meditation practice on a weekend follows session 5 or 6. Participants also engage in a daily meditation practice and homework exercises directed at integrating awareness skills into daily life.

Meta-analytic and narrative reviews generally support MBSR’s efficacy for a wide range of clinical presentations, including improved quality of life for chronic pain and cancer patients.^5,8-11 Variability in the methodologic rigor of clinical trials of mindfulness-based interventions—such as lack of active control groups and small sample sizes—limits the strength of these studies’ conclusions, however.⁸

MBCT integrates the mindfulness training of MBSR with cognitive therapy techniques ( Table 1 ) to prevent the consolidation of ruminative, negative thinking patterns that contribute to depressive relapse.² These cognitive therapy techniques include:

• psychoeducation about depression symptoms and automatic thoughts
• exercises designed to demonstrate the cognitive model
• identifying activities that provide feelings of mastery and/or pleasure
• creating a specific relapse prevention plan.

In addition, MBCT introduces a new informal meditation—the 3-minute breathing space—to facilitate present-moment awareness in upsetting everyday situations.

Evidence supporting MBCT comes from randomized, controlled trials (RCTs) and uncontrolled trials ( Table 2 ).^12-18 A systematic review of RCTs supported using MBCT in addition to usual care to prevent depressive relapse in individuals with a history of ≥3 depressive episodes.¹⁹ Since that review was published, a large RCT (123 patients) comparing antidepressant medication alone to antidepressants plus adjunctive MBCT with support to taper/discontinue antidepressant therapy found:

• MBCT comparable to maintenance antidepressant medication in preventing depressive relapse for individuals with ≥3 depressive episodes
• no difference in cost between these 2 treatments.¹²

In this study, MBCT was more effective than maintenance pharmacotherapy in reducing residual depressive symptoms and in improving quality of life; 75% in the MBCT group discontinued antidepressants. MBCT is included in the United Kingdom’s National Institute for Clinical Excellence Clinical Practice Guidelines for Depression²⁰ for prevention of recurrent depression.

RCTs and uncontrolled studies have shown that MBCT reduces depressive and anxious symptoms in individuals suffering from mood disorders. In an open-label pilot study of MBCT’s efficacy in reducing depressive symptoms in patients with treatment-resistant depression and ≥3 depressive episodes, 61% of patients achieved a post-MBCT Beck Depression Inventory-II (BDI-II) score <14, which represents normal or near-normal mood (mean BDI-II scores decreased from 24.3 to 13.9; effect size 1.04).¹⁷

Mindfulness for other psychiatric conditions. A review by Toneatto and Nguyen²¹ of MBSR in the treatment of anxiety and depression symptoms in a range of clinical populations concluded that the evidence supporting a beneficial effect was equivocal. On the other hand, several uncontrolled studies and 1 RCT indicate that mindfulness-based treatments can reduce symptoms in other psychiatric conditions, including eating disorders,²² generalized anxiety disorder,²³ bipolar disorder,²⁴ and attention-deficit/hyperactivity disorder.²⁵ Many of these studies were developed to target mood and anxiety symptoms by linking mindfulness and symptom management; this differs from MBSR, which focuses on stress reduction. Methodologically rigorous studies are necessary to evaluate mindfulness-based treatments in these and other psychiatric conditions.

Table 1

Skills and practices taught in mindfulness training

Table 2

Evidence of reduced depressive symptoms, anxiety with MBCT

CASE CONTINUED: Explaining the potential benefits

You inform Mr. A that MBCT has been shown to improve acute mild-to-moderate depressive symptoms, may decrease his risk of depressive relapse by 50%²⁶ and could help him discontinue his medications.¹² He asks how mindfulness exercises will help his symptoms.

How mindfulness works

The assumption that increased mindfulness mediates treatment outcomes⁴ has been addressed systematically only recently, following the development of operational definitions of mindfulness and self-report mindfulness measures, including the:

• Mindful Attention Awareness Scale (MAAS)²⁷
• Five Facet Mindfulness Questionnaire (FFMQ)¹²
• Toronto Mindfulness Scale (TMS).²⁸

Uncontrolled studies using these measures demonstrated that self-reported mindfulness increased following MBSR^28,29 and MBCT^15,18 in individuals with general stress, anxiety disorder or primary depression, cancer, chronic pain disorder, diabetes, and multiple sclerosis. Accumulating evidence from 1 RCT³⁰ and 2 other uncontrolled studies^28,31 demonstrates that mindfulness is associated with symptom reduction following MBSR.

Researchers have begun to focus on how mindfulness skills reduce symptoms. Baer⁹ proposed several mechanisms, including:

• cognitive change
• improved self-management
• exposure to painful experiences leading to reduced emotional reactivity.

Cognitive change—also called meta-cognitive awareness—is the development of a “distanced “or “decentered” perspective in which patients experience their thoughts and feelings as “mental events” rather than as true, accurate versions of reality. This is thought to introduce a “space” between perception and response that enables patients to have a reflective—rather than a reflexive or reactive—response to situations, which in turn reduces vulnerability to psychological processes that contribute to emotional suffering. Some preliminary evidence suggests that MBCT-associated increases in metacognitive awareness reduce risk of depressive relapse.³²

Teaching mindfulness

Guidelines for psychiatrists who wish to become MBCT instructors suggest undergoing formal teacher development training, attending a 7- to 10-day meditation retreat, and establishing your own daily mindfulness practice ( Table 3 ).³³ Segal et al² also recommend recognized training in counseling, psychotherapy, or as a mental health professional, as well as training in cognitive therapy and having experience leading psychotherapy groups.

The recommendation that a mindfulness teacher should practice meditation derives from the view that instructors teach from their own meditation experience and embody the attitudes they invite participants to practice. In an RCT, patients of psychotherapists in training (PiTs) who practiced meditation had greater symptom reductions than those of PiTs who did not engage in meditation.³⁴

To cultivate your own mindfulness practice, consider enrolling in an MBSR group, participating in an MBCT training retreat (see Related Resources ), or attending a mindfulness meditation retreat.

Although patient access to MBCT and MBSR programs has been increasing, formal MBSR/MBCT group programs led by trained therapists are limited. Patients can go through an MBSR/MBCT book with a trained clinician or listen to audio recordings with guided meditation instructions. Alternately, they can join a meditation sitting group or an insight meditation correspondence course ( Table 4 ).

Table 3

Recommended process for becoming an MBCT instructor

Table 4

Useful mindfulness resources for interested patients

CASE CONTINUED: Daily mindfulness practice

Mr. A enrolls in and completes a group MBCT program. He rearranges his schedule to include 30 minutes of formal mindfulness practice daily. During an office visit after completing the MBCT course, he describes decreased irritability and self-criticism, newfound self-acceptance, an increased ability to tolerate previously distressing affect, and the ability to set realistic expectations of himself, particularly in light of increased responsibilities at work. He also reports an increased sense of engagement in and reward in his personal life.

Several months later he requests and successfully completes an antidepressant taper and has no recurrence of depressive episodes at 18-month follow-up. He participates in monthly meditation groups to support his home practice.

Related resources

• Germer CK, Siegel R, Fulton PR, eds. Mindfulness and psychotherapy. New York, NY: Guilford Press; 2005.
• Mindfulness-based cognitive therapy. www.mbct.com; www.mbct.co.uk; www.bangor.ac.uk/mindfulness.
• Center for Mindfulness in Medicine, Health Care, and Society. www.umassmed.edu/cfm.
• Neurobiology of mindfulness. www.mindfulness-matters.org.
• Siegel DJ. The mindful brain: reflection and attunement in the cultivation of well-being. New York, NY: Norton; 2007.
• University of California, San Diego Center for Mindfulness. http://cme.ucsd.edu/mindfulness.

Drug brand names

• Bupropion • Wellbutrin
• Escitalopram • Lexapro

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Acknowledgment

The authors would like to thank Amanda Yu for her assistance in preparing the manuscript.

The first quadrivalent human papillomavirus vaccine (HPV4) was licensed in the United States in 2006 (Gardasil, Merck & Co., Inc.).¹ It contains viral proteins from HPV types 18, 16, 11, and 6, the types currently responsible for 70% of cervical cancers and 90% of anogenital warts.² The vaccine is licensed for use in females ages 9 to 26 years for the prevention of cervical, vulvar, and vaginal precancerous lesions and cancer, and for the prevention of anogenital warts.¹ It was recently licensed in the United States for the prevention of anogenital warts in males, as it has been in other countries.^2,3

HPV and cancer: Quantifying the threat

Human papillomavirus (HPV) is responsible for cancers at several anatomical sites, including the cervix, anus, oral mucosa, vulva, vagina, and penis.¹ The rate of cervical cancer in the United States has declined markedly since the introduction of screening programs using cervical cytology testing.¹ This decline has been predominantly in squamous cell carcinomas, not adenocarcinomas, which are located in the endocervix and harder to detect.¹

There are still around 12,000 cases of cervical cancer diagnosed each year in the United States, for an incidence of 8.1/100,000 women, and 3924 cervical cancer-related deaths.¹ In addition, 7% to 10% of the 50 million cervical cytology tests done each year require some form of follow-up. Of these, 2 million to 3 million findings requiring follow-up are atypical squamous cells of undetermined significance (ASC-US) and 1.25 million are low-grade squamous intraepithelial lesions.¹

There were more than 4000 cases of anal cancer recorded in 2003, a rate of 1.6/100,000 in women and 1.3/100,000 in men. In contrast to the trend in cervical cancer rates, anal cancer rates are increasing.⁴ It is not known how many incident cases of genital and anal warts there are annually, but some estimates place the number as high as 1 million. Lifetime cumulative risk has been estimated at 10%.⁵

Global morbidity and mortality from HPV is considerable, with 500,000 cases of cervical cancer and 260,000 cervical cancerrelated deaths reported worldwide in 2005.² Rates are highest in developing countries in Latin America, Africa, and Asia.²

The vaccine is effective in women

HPV4 has proven to be highly effective in women ages 15 to 26 who have not been previously infected with the HPV types in the vaccine. Effectiveness has been 98% to 100% after 3 to 5 years in these women, using such end points as moderate and severe cervical intraepithelial neoplasia (CIN2 and CIN3), endocervical adenocarcinoma in situ (AIS), anogenital warts, and vulvar and vaginal intraepithelial neoplasia.^1,2,6 These trials are ongoing.

Efficacy among women with current or past HPV infection is less certain. Studies of this question have included only small numbers and the confidence intervals have been large and included 0. In intention-to-treat studies, efficacy has been 39% to 46% for prevention of CIN2 or 3 and AIS caused by HPV 16 and 18, 69% for prevention of HPV 16/18-related vaginal intraepithelial neoplasia, and 68.5% for vaccine type-related warts.¹

Who should be vaccinated?

According to the June 2006 recommendations of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), immunization with 3 doses of HPV4 should be routine for girls between the ages of 11 and 12. Vaccination may be started in girls as young as age 9 and can also be done for females between the ages of 13 and 26.¹ The ACIP recommendations are summarized in TABLE 1.

The World Health Organization (WHO) qualifies its recommendations a bit. “Routine HPV vaccination,” notes WHO, “should be included in national immunization programs provided that:

• prevention of cervical cancer or other HPV-related diseases, or both, constitutes a public health priority,
• vaccine introduction is programmatically feasible,
• sustainable financing can be secured, and
• the cost effectiveness of vaccination strategies in the country or region are considered.”²

WHO also says the vaccine is most effective prior to HPV infection and that, based on the age of initiation of sexual activity, the target population is most likely to be females 9 to 13 years of age. WHO does not recommend vaccination in males.²

In the United States, most professional organizations, including the American Academy of Family Physicians, have adopted recommendations in line with those of ACIP. One exception is the American Cancer Society (ACS), which takes issue with ACIP’s recommendations for the 19- to 26-year age group. The ACS position is that the evidence is insufficient to recommend for or against routine use of the HPV vaccine for this age group.⁷

TABLE 1
ACIP HPV4 recommendations¹

Some doubts among parents and physicians

Recent national vaccine survey data show that only 25% of females ages 13 to 17 had received 1 or more doses of HPV4 vaccine.⁸ Young women appear to be interested in the vaccine and in possibly receiving it, but they tend to underestimate their risk of contracting HPV.^9,10 Some parents are concerned that the vaccine may encourage risk-taking behavior.¹¹ Physicians report that some parents fear the vaccine is too new to be fully evaluated and are concerned that insurance may not cover the cost of the 3-shot series.¹²

Physician attitudes toward the vaccine are generally positive. Close to 90% of family physicians and 98% of pediatricians administer the vaccine in their practices. Eighty percent strongly recommend it to 13- to 15-year-olds, and 50% recommend it to 11- to 12-year-olds.

A small minority of family physicians has misconceptions regarding the vaccine:

• 15% believe an HPV test should be ordered before vaccination
• 19% believe the vaccine should not be given to those diagnosed with HPV
• 31% believe a pregnancy test should be ordered before administering the vaccine.¹²

Safety concerns, minor and major

Clinical trials conducted by the vaccine manufacturer demonstrated slightly higher rates of some systemic adverse reactions in the vaccinated group compared with placebo groups (TABLE 2). Data on adverse reactions at the injection site also showed somewhat higher percentages in the vaccine group. These trials were not large enough to detect severe, rare adverse reactions.

The CDC and the US Food and Drug Administration (FDA) collaboratively operate a passive reporting system, the Vaccine Adverse Events Reporting System (VAERS), as a way of conducting surveillance for these rare events. The manufacturer is required to report suspected adverse events to VAERS, but providers and consumers can also report any suspected adverse events.

There are problems with VAERS. Because it is a passive system, some adverse events may not be reported. At the same time, some events reported by consumers and physicians may be coincidental occurrences not caused by the vaccine. To complicate matters further, patients often receive more than 1 vaccine at the same time, so that attributing any particular adverse reaction to a single vaccine is problematic. These imperfections in VAERS should lead to caution in interpreting reports received on any 1 vaccine.

A recent article published in the Journal of the American Medical Association (JAMA) described the reports on the HPV4 vaccine received by the VAERS for the first 2½ years after licensure.¹³ Slightly more than 23 million doses had been distributed during this time, and 12,424 adverse events were reported. The most common were syncope (1847), dizziness (1763), nausea (1170), headache (957), and injection site reactions (926). Of all these reported events, 772 reactions were classified as serious, and 32 vaccine recipients died. Investigation of the deaths revealed that the mean time from vaccine to the death was 47 days, the deaths were caused by a variety of underlying conditions, and 4 deaths remained unexplained.

The only 2 serious adverse events that appeared to occur more frequently than background rates were venous thrombotic events, at 1 per 500,000 doses, and syncope, at a rate of 8.2 per 100,000 doses. The syncopal events were concentrated among the 11- to 18-year-olds and resulted in 293 falls and 200 head injuries. The authors of the JAMA article caution about attributing any cause and effect to the venous thromboembolism findings because of the high rates of oral contraceptive use in this age group, which increases the risk of this condition. Studies are ongoing to try to sort out these issues.

TABLE 2
HPV4 systemic adverse events in females, ages 9-23 years¹

New developments: HPV4 for boys, licensing a bivalent vaccine

At its meeting in October 2009, ACIP decided to approve HPV4 for the prevention of anogenital warts in boys and young men ages 9 to 26.¹⁴ The potential benefits of using the HPV vaccine in males include reduced incidence of anogenital warts, possible reduction in HPV-related cancers, and reduced transmission of the HPV viruses in the vaccine to women and other men. The ACIP panel did not recommend routine immunization, however, leaving it up to physicians and patients to decide whether the vaccine is worthwhile. The advisory group said it would take up the question of the vaccine’s effectiveness in preventing HPV-related male cancers at future meetings.

At the same meeting, ACIP also voted to recommend Cervarix, the bivalent HPV vaccine from GlaxoSmithKline, for routine use in girls 11 and 12 years of age for the prevention of cancer and precancerous lesions.¹⁴ This vaccine contains antigens against HPV types 16 and 18 and does not provide protection against genital warts. Cervarix has been licensed in other countries and, to date, has demonstrated effectiveness comparable to that of the HPV4 against HPV 16- and 18-related outcomes.^1,2,6

The availability of 2 HPV vaccines, 1 against both warts and cervical cancer and the other against cervical cancer only, will present some challenging ethical and practical issues for ACIP, as well as for states and physicians.

Unresolved issues

Some critics of the vaccine have pointed out that neither HPV vaccine has yet been proven to prevent cervical cancer. Because the amount of time it takes HPV infection to progress to cervical cancer is, on average, 10 to 20 years, vaccine trials will need to be continued for years to establish this point. However, high-grade cervical lesions and genital warts are outcomes important to patients on their own and are associated with considerable morbidity. It is unknown how continued use of the vaccine will affect the epidemiology of HPV infection and the incidence of HPV types not affected by the vaccine.

Safety monitoring of the vaccine continues. At this time it appears that syncopal episodes occur at increased rates shortly after administration of the HPV4 vaccine, and vaccine providers are encouraged to follow ACIP recommendations of a 15-minute waiting period after the administration of the vaccine.¹³ Ongoing studies will continue to look at potential rare adverse reactions and determine if the vaccine is truly a cause of venous thromboembolic events.

The approved age range for the use of HPV4 in women for the prevention of cancer, precancerous lesions, and warts may be expanded above 26 years. The benefit among women of this age will be less than for younger women, because of the higher probability of previous exposure to HPV. ACIP will need to decide on whether the vaccine should be routinely or selectively recommended above age 26.

The first quadrivalent human papillomavirus vaccine (HPV4) was licensed in the United States in 2006 (Gardasil, Merck & Co., Inc.).¹ It contains viral proteins from HPV types 18, 16, 11, and 6, the types currently responsible for 70% of cervical cancers and 90% of anogenital warts.² The vaccine is licensed for use in females ages 9 to 26 years for the prevention of cervical, vulvar, and vaginal precancerous lesions and cancer, and for the prevention of anogenital warts.¹ It was recently licensed in the United States for the prevention of anogenital warts in males, as it has been in other countries.^2,3

HPV and cancer: Quantifying the threat

Human papillomavirus (HPV) is responsible for cancers at several anatomical sites, including the cervix, anus, oral mucosa, vulva, vagina, and penis.¹ The rate of cervical cancer in the United States has declined markedly since the introduction of screening programs using cervical cytology testing.¹ This decline has been predominantly in squamous cell carcinomas, not adenocarcinomas, which are located in the endocervix and harder to detect.¹

There are still around 12,000 cases of cervical cancer diagnosed each year in the United States, for an incidence of 8.1/100,000 women, and 3924 cervical cancer-related deaths.¹ In addition, 7% to 10% of the 50 million cervical cytology tests done each year require some form of follow-up. Of these, 2 million to 3 million findings requiring follow-up are atypical squamous cells of undetermined significance (ASC-US) and 1.25 million are low-grade squamous intraepithelial lesions.¹

There were more than 4000 cases of anal cancer recorded in 2003, a rate of 1.6/100,000 in women and 1.3/100,000 in men. In contrast to the trend in cervical cancer rates, anal cancer rates are increasing.⁴ It is not known how many incident cases of genital and anal warts there are annually, but some estimates place the number as high as 1 million. Lifetime cumulative risk has been estimated at 10%.⁵

Global morbidity and mortality from HPV is considerable, with 500,000 cases of cervical cancer and 260,000 cervical cancerrelated deaths reported worldwide in 2005.² Rates are highest in developing countries in Latin America, Africa, and Asia.²

The vaccine is effective in women

HPV4 has proven to be highly effective in women ages 15 to 26 who have not been previously infected with the HPV types in the vaccine. Effectiveness has been 98% to 100% after 3 to 5 years in these women, using such end points as moderate and severe cervical intraepithelial neoplasia (CIN2 and CIN3), endocervical adenocarcinoma in situ (AIS), anogenital warts, and vulvar and vaginal intraepithelial neoplasia.^1,2,6 These trials are ongoing.

Efficacy among women with current or past HPV infection is less certain. Studies of this question have included only small numbers and the confidence intervals have been large and included 0. In intention-to-treat studies, efficacy has been 39% to 46% for prevention of CIN2 or 3 and AIS caused by HPV 16 and 18, 69% for prevention of HPV 16/18-related vaginal intraepithelial neoplasia, and 68.5% for vaccine type-related warts.¹

Who should be vaccinated?

According to the June 2006 recommendations of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), immunization with 3 doses of HPV4 should be routine for girls between the ages of 11 and 12. Vaccination may be started in girls as young as age 9 and can also be done for females between the ages of 13 and 26.¹ The ACIP recommendations are summarized in TABLE 1.

The World Health Organization (WHO) qualifies its recommendations a bit. “Routine HPV vaccination,” notes WHO, “should be included in national immunization programs provided that:

• prevention of cervical cancer or other HPV-related diseases, or both, constitutes a public health priority,
• vaccine introduction is programmatically feasible,
• sustainable financing can be secured, and
• the cost effectiveness of vaccination strategies in the country or region are considered.”²

WHO also says the vaccine is most effective prior to HPV infection and that, based on the age of initiation of sexual activity, the target population is most likely to be females 9 to 13 years of age. WHO does not recommend vaccination in males.²

In the United States, most professional organizations, including the American Academy of Family Physicians, have adopted recommendations in line with those of ACIP. One exception is the American Cancer Society (ACS), which takes issue with ACIP’s recommendations for the 19- to 26-year age group. The ACS position is that the evidence is insufficient to recommend for or against routine use of the HPV vaccine for this age group.⁷

TABLE 1
ACIP HPV4 recommendations¹

Some doubts among parents and physicians

Recent national vaccine survey data show that only 25% of females ages 13 to 17 had received 1 or more doses of HPV4 vaccine.⁸ Young women appear to be interested in the vaccine and in possibly receiving it, but they tend to underestimate their risk of contracting HPV.^9,10 Some parents are concerned that the vaccine may encourage risk-taking behavior.¹¹ Physicians report that some parents fear the vaccine is too new to be fully evaluated and are concerned that insurance may not cover the cost of the 3-shot series.¹²

Physician attitudes toward the vaccine are generally positive. Close to 90% of family physicians and 98% of pediatricians administer the vaccine in their practices. Eighty percent strongly recommend it to 13- to 15-year-olds, and 50% recommend it to 11- to 12-year-olds.

A small minority of family physicians has misconceptions regarding the vaccine:

• 15% believe an HPV test should be ordered before vaccination
• 19% believe the vaccine should not be given to those diagnosed with HPV
• 31% believe a pregnancy test should be ordered before administering the vaccine.¹²

Safety concerns, minor and major

Clinical trials conducted by the vaccine manufacturer demonstrated slightly higher rates of some systemic adverse reactions in the vaccinated group compared with placebo groups (TABLE 2). Data on adverse reactions at the injection site also showed somewhat higher percentages in the vaccine group. These trials were not large enough to detect severe, rare adverse reactions.

The CDC and the US Food and Drug Administration (FDA) collaboratively operate a passive reporting system, the Vaccine Adverse Events Reporting System (VAERS), as a way of conducting surveillance for these rare events. The manufacturer is required to report suspected adverse events to VAERS, but providers and consumers can also report any suspected adverse events.

There are problems with VAERS. Because it is a passive system, some adverse events may not be reported. At the same time, some events reported by consumers and physicians may be coincidental occurrences not caused by the vaccine. To complicate matters further, patients often receive more than 1 vaccine at the same time, so that attributing any particular adverse reaction to a single vaccine is problematic. These imperfections in VAERS should lead to caution in interpreting reports received on any 1 vaccine.

A recent article published in the Journal of the American Medical Association (JAMA) described the reports on the HPV4 vaccine received by the VAERS for the first 2½ years after licensure.¹³ Slightly more than 23 million doses had been distributed during this time, and 12,424 adverse events were reported. The most common were syncope (1847), dizziness (1763), nausea (1170), headache (957), and injection site reactions (926). Of all these reported events, 772 reactions were classified as serious, and 32 vaccine recipients died. Investigation of the deaths revealed that the mean time from vaccine to the death was 47 days, the deaths were caused by a variety of underlying conditions, and 4 deaths remained unexplained.

The only 2 serious adverse events that appeared to occur more frequently than background rates were venous thrombotic events, at 1 per 500,000 doses, and syncope, at a rate of 8.2 per 100,000 doses. The syncopal events were concentrated among the 11- to 18-year-olds and resulted in 293 falls and 200 head injuries. The authors of the JAMA article caution about attributing any cause and effect to the venous thromboembolism findings because of the high rates of oral contraceptive use in this age group, which increases the risk of this condition. Studies are ongoing to try to sort out these issues.

TABLE 2
HPV4 systemic adverse events in females, ages 9-23 years¹

New developments: HPV4 for boys, licensing a bivalent vaccine

At its meeting in October 2009, ACIP decided to approve HPV4 for the prevention of anogenital warts in boys and young men ages 9 to 26.¹⁴ The potential benefits of using the HPV vaccine in males include reduced incidence of anogenital warts, possible reduction in HPV-related cancers, and reduced transmission of the HPV viruses in the vaccine to women and other men. The ACIP panel did not recommend routine immunization, however, leaving it up to physicians and patients to decide whether the vaccine is worthwhile. The advisory group said it would take up the question of the vaccine’s effectiveness in preventing HPV-related male cancers at future meetings.

At the same meeting, ACIP also voted to recommend Cervarix, the bivalent HPV vaccine from GlaxoSmithKline, for routine use in girls 11 and 12 years of age for the prevention of cancer and precancerous lesions.¹⁴ This vaccine contains antigens against HPV types 16 and 18 and does not provide protection against genital warts. Cervarix has been licensed in other countries and, to date, has demonstrated effectiveness comparable to that of the HPV4 against HPV 16- and 18-related outcomes.^1,2,6

The availability of 2 HPV vaccines, 1 against both warts and cervical cancer and the other against cervical cancer only, will present some challenging ethical and practical issues for ACIP, as well as for states and physicians.

Unresolved issues

Some critics of the vaccine have pointed out that neither HPV vaccine has yet been proven to prevent cervical cancer. Because the amount of time it takes HPV infection to progress to cervical cancer is, on average, 10 to 20 years, vaccine trials will need to be continued for years to establish this point. However, high-grade cervical lesions and genital warts are outcomes important to patients on their own and are associated with considerable morbidity. It is unknown how continued use of the vaccine will affect the epidemiology of HPV infection and the incidence of HPV types not affected by the vaccine.

Safety monitoring of the vaccine continues. At this time it appears that syncopal episodes occur at increased rates shortly after administration of the HPV4 vaccine, and vaccine providers are encouraged to follow ACIP recommendations of a 15-minute waiting period after the administration of the vaccine.¹³ Ongoing studies will continue to look at potential rare adverse reactions and determine if the vaccine is truly a cause of venous thromboembolic events.

The approved age range for the use of HPV4 in women for the prevention of cancer, precancerous lesions, and warts may be expanded above 26 years. The benefit among women of this age will be less than for younger women, because of the higher probability of previous exposure to HPV. ACIP will need to decide on whether the vaccine should be routinely or selectively recommended above age 26.

The first quadrivalent human papillomavirus vaccine (HPV4) was licensed in the United States in 2006 (Gardasil, Merck & Co., Inc.).¹ It contains viral proteins from HPV types 18, 16, 11, and 6, the types currently responsible for 70% of cervical cancers and 90% of anogenital warts.² The vaccine is licensed for use in females ages 9 to 26 years for the prevention of cervical, vulvar, and vaginal precancerous lesions and cancer, and for the prevention of anogenital warts.¹ It was recently licensed in the United States for the prevention of anogenital warts in males, as it has been in other countries.^2,3

HPV and cancer: Quantifying the threat

Human papillomavirus (HPV) is responsible for cancers at several anatomical sites, including the cervix, anus, oral mucosa, vulva, vagina, and penis.¹ The rate of cervical cancer in the United States has declined markedly since the introduction of screening programs using cervical cytology testing.¹ This decline has been predominantly in squamous cell carcinomas, not adenocarcinomas, which are located in the endocervix and harder to detect.¹

There are still around 12,000 cases of cervical cancer diagnosed each year in the United States, for an incidence of 8.1/100,000 women, and 3924 cervical cancer-related deaths.¹ In addition, 7% to 10% of the 50 million cervical cytology tests done each year require some form of follow-up. Of these, 2 million to 3 million findings requiring follow-up are atypical squamous cells of undetermined significance (ASC-US) and 1.25 million are low-grade squamous intraepithelial lesions.¹

There were more than 4000 cases of anal cancer recorded in 2003, a rate of 1.6/100,000 in women and 1.3/100,000 in men. In contrast to the trend in cervical cancer rates, anal cancer rates are increasing.⁴ It is not known how many incident cases of genital and anal warts there are annually, but some estimates place the number as high as 1 million. Lifetime cumulative risk has been estimated at 10%.⁵

Global morbidity and mortality from HPV is considerable, with 500,000 cases of cervical cancer and 260,000 cervical cancerrelated deaths reported worldwide in 2005.² Rates are highest in developing countries in Latin America, Africa, and Asia.²

The vaccine is effective in women

HPV4 has proven to be highly effective in women ages 15 to 26 who have not been previously infected with the HPV types in the vaccine. Effectiveness has been 98% to 100% after 3 to 5 years in these women, using such end points as moderate and severe cervical intraepithelial neoplasia (CIN2 and CIN3), endocervical adenocarcinoma in situ (AIS), anogenital warts, and vulvar and vaginal intraepithelial neoplasia.^1,2,6 These trials are ongoing.

Efficacy among women with current or past HPV infection is less certain. Studies of this question have included only small numbers and the confidence intervals have been large and included 0. In intention-to-treat studies, efficacy has been 39% to 46% for prevention of CIN2 or 3 and AIS caused by HPV 16 and 18, 69% for prevention of HPV 16/18-related vaginal intraepithelial neoplasia, and 68.5% for vaccine type-related warts.¹

Who should be vaccinated?

According to the June 2006 recommendations of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), immunization with 3 doses of HPV4 should be routine for girls between the ages of 11 and 12. Vaccination may be started in girls as young as age 9 and can also be done for females between the ages of 13 and 26.¹ The ACIP recommendations are summarized in TABLE 1.

The World Health Organization (WHO) qualifies its recommendations a bit. “Routine HPV vaccination,” notes WHO, “should be included in national immunization programs provided that:

• prevention of cervical cancer or other HPV-related diseases, or both, constitutes a public health priority,
• vaccine introduction is programmatically feasible,
• sustainable financing can be secured, and
• the cost effectiveness of vaccination strategies in the country or region are considered.”²

WHO also says the vaccine is most effective prior to HPV infection and that, based on the age of initiation of sexual activity, the target population is most likely to be females 9 to 13 years of age. WHO does not recommend vaccination in males.²

In the United States, most professional organizations, including the American Academy of Family Physicians, have adopted recommendations in line with those of ACIP. One exception is the American Cancer Society (ACS), which takes issue with ACIP’s recommendations for the 19- to 26-year age group. The ACS position is that the evidence is insufficient to recommend for or against routine use of the HPV vaccine for this age group.⁷

TABLE 1
ACIP HPV4 recommendations¹

Some doubts among parents and physicians

Recent national vaccine survey data show that only 25% of females ages 13 to 17 had received 1 or more doses of HPV4 vaccine.⁸ Young women appear to be interested in the vaccine and in possibly receiving it, but they tend to underestimate their risk of contracting HPV.^9,10 Some parents are concerned that the vaccine may encourage risk-taking behavior.¹¹ Physicians report that some parents fear the vaccine is too new to be fully evaluated and are concerned that insurance may not cover the cost of the 3-shot series.¹²

Physician attitudes toward the vaccine are generally positive. Close to 90% of family physicians and 98% of pediatricians administer the vaccine in their practices. Eighty percent strongly recommend it to 13- to 15-year-olds, and 50% recommend it to 11- to 12-year-olds.

A small minority of family physicians has misconceptions regarding the vaccine:

• 15% believe an HPV test should be ordered before vaccination
• 19% believe the vaccine should not be given to those diagnosed with HPV
• 31% believe a pregnancy test should be ordered before administering the vaccine.¹²

Safety concerns, minor and major

Clinical trials conducted by the vaccine manufacturer demonstrated slightly higher rates of some systemic adverse reactions in the vaccinated group compared with placebo groups (TABLE 2). Data on adverse reactions at the injection site also showed somewhat higher percentages in the vaccine group. These trials were not large enough to detect severe, rare adverse reactions.

The CDC and the US Food and Drug Administration (FDA) collaboratively operate a passive reporting system, the Vaccine Adverse Events Reporting System (VAERS), as a way of conducting surveillance for these rare events. The manufacturer is required to report suspected adverse events to VAERS, but providers and consumers can also report any suspected adverse events.

There are problems with VAERS. Because it is a passive system, some adverse events may not be reported. At the same time, some events reported by consumers and physicians may be coincidental occurrences not caused by the vaccine. To complicate matters further, patients often receive more than 1 vaccine at the same time, so that attributing any particular adverse reaction to a single vaccine is problematic. These imperfections in VAERS should lead to caution in interpreting reports received on any 1 vaccine.

A recent article published in the Journal of the American Medical Association (JAMA) described the reports on the HPV4 vaccine received by the VAERS for the first 2½ years after licensure.¹³ Slightly more than 23 million doses had been distributed during this time, and 12,424 adverse events were reported. The most common were syncope (1847), dizziness (1763), nausea (1170), headache (957), and injection site reactions (926). Of all these reported events, 772 reactions were classified as serious, and 32 vaccine recipients died. Investigation of the deaths revealed that the mean time from vaccine to the death was 47 days, the deaths were caused by a variety of underlying conditions, and 4 deaths remained unexplained.

The only 2 serious adverse events that appeared to occur more frequently than background rates were venous thrombotic events, at 1 per 500,000 doses, and syncope, at a rate of 8.2 per 100,000 doses. The syncopal events were concentrated among the 11- to 18-year-olds and resulted in 293 falls and 200 head injuries. The authors of the JAMA article caution about attributing any cause and effect to the venous thromboembolism findings because of the high rates of oral contraceptive use in this age group, which increases the risk of this condition. Studies are ongoing to try to sort out these issues.

TABLE 2
HPV4 systemic adverse events in females, ages 9-23 years¹

New developments: HPV4 for boys, licensing a bivalent vaccine

At its meeting in October 2009, ACIP decided to approve HPV4 for the prevention of anogenital warts in boys and young men ages 9 to 26.¹⁴ The potential benefits of using the HPV vaccine in males include reduced incidence of anogenital warts, possible reduction in HPV-related cancers, and reduced transmission of the HPV viruses in the vaccine to women and other men. The ACIP panel did not recommend routine immunization, however, leaving it up to physicians and patients to decide whether the vaccine is worthwhile. The advisory group said it would take up the question of the vaccine’s effectiveness in preventing HPV-related male cancers at future meetings.

At the same meeting, ACIP also voted to recommend Cervarix, the bivalent HPV vaccine from GlaxoSmithKline, for routine use in girls 11 and 12 years of age for the prevention of cancer and precancerous lesions.¹⁴ This vaccine contains antigens against HPV types 16 and 18 and does not provide protection against genital warts. Cervarix has been licensed in other countries and, to date, has demonstrated effectiveness comparable to that of the HPV4 against HPV 16- and 18-related outcomes.^1,2,6

The availability of 2 HPV vaccines, 1 against both warts and cervical cancer and the other against cervical cancer only, will present some challenging ethical and practical issues for ACIP, as well as for states and physicians.

Unresolved issues

Some critics of the vaccine have pointed out that neither HPV vaccine has yet been proven to prevent cervical cancer. Because the amount of time it takes HPV infection to progress to cervical cancer is, on average, 10 to 20 years, vaccine trials will need to be continued for years to establish this point. However, high-grade cervical lesions and genital warts are outcomes important to patients on their own and are associated with considerable morbidity. It is unknown how continued use of the vaccine will affect the epidemiology of HPV infection and the incidence of HPV types not affected by the vaccine.

Safety monitoring of the vaccine continues. At this time it appears that syncopal episodes occur at increased rates shortly after administration of the HPV4 vaccine, and vaccine providers are encouraged to follow ACIP recommendations of a 15-minute waiting period after the administration of the vaccine.¹³ Ongoing studies will continue to look at potential rare adverse reactions and determine if the vaccine is truly a cause of venous thromboembolic events.

The approved age range for the use of HPV4 in women for the prevention of cancer, precancerous lesions, and warts may be expanded above 26 years. The benefit among women of this age will be less than for younger women, because of the higher probability of previous exposure to HPV. ACIP will need to decide on whether the vaccine should be routinely or selectively recommended above age 26.

CASE: Refractory depression

Ms. W, age 38, is brought to the emergency department after her son finds her unresponsive and calls 911. Suffering from worsening depression, she wrote a note telling her children goodbye, and overdosed on zolpidem from an old prescription and her daughter’s opioids. After being evaluated and medically cleared in the emergency department, Ms. W was admitted to the psychiatric unit.

Ms. W has a history of recurrent major depressive disorder that developed after she was sexually abused by a relative as a teen. She also has bulimia nervosa, alcohol dependence, and posttraumatic stress disorder. She was hospitalized twice for depression and suicidality but had not previously attempted suicide. In the mid-to-late 1990s, she had trials of paroxetine, clomipramine, lithium, and bupropion.

She was seen regularly in our outpatient psychiatry clinic for medication management and supportive psychotherapy. Since being followed in our clinic starting in early 2005, she has had the following medication trials:

• fluoxetine, citalopram, venlafaxine XR, and duloxetine for depression
• atomoxetine, buspirone, liothyronine, risperidone, and aripiprazole for antidepressant augmentation
• lorazepam, clonazepam, and gabapentin for anxiety
• zolpidem and trazodone for insomnia
• nortriptyline for migraine headache prophylaxis.

Some medications were not tolerated, primarily because of increased anxiety. Those that were tolerated were adequate trials in terms of dose titration and length. High-dose fluoxetine (80 mg/d) augmented by risperidone (0.375 to 0.5 mg/d) produced the most reliable and significant improvement.

Ms. W had 2 courses of electroconvulsive therapy (ECT) totaling 30 treatments—most recently in 2007—that resulted in significant memory loss with limited benefit. Premenstrual worsening of depression and suicidality were noted. In collaboration with her gynecologist, Ms. W was treated with a 3-month trial of leuprolide to suppress her ovarian axis, which was helpful. In 2008 she underwent bilateral oophorectomy. She has not had symptoms of mood elevation or psychosis. Family history includes schizophrenia, depression, anxiety, and alcoholism.

In the months before hospitalization, Ms. W had been increasingly depressed and intermittently suicidal, although she did not endorse a specific plan or intention to harm herself because she was concerned about the impact suicide would have on her children. Weight gain with risperidone had reactivated body image issues, so Ms. W stopped taking this medication 2 weeks before hospitalization. Her depression became worse, and she began using her husband’s hydrocodone/acetaminophen prescription.

The authors’ observations

Approximately 40% of patients with major depression fail to respond to an initial antidepressant trial.¹ An additional 50% of these patients will be treatment-resistant to a subsequent antidepressant.¹ Patients may be progressively less likely to respond to additional medication trials.²

One of the most rapid-acting and effective treatments for unipolar and bipolar depression is sleep deprivation. Wirz-Justice et al³ found total or partial sleep deprivation during the second half of the night induced rapid depression remission. Response rates range from 40% to 60% over hours to days.⁴ Sleep deprivation also can reduce suicidality in patients with seasonal depression.⁵ This treatment has not been widely employed, however, because up to 80% of patients who undergo sleep deprivation experience rapid and significant depressive relapse.⁴

Sleep deprivation usually is well tolerated. Potential side effects include:

• headache
• gastrointestinal upset
• fatigue
• cognitive impairment.

Less often, patients report worsening of depressive symptoms and, rarely, suicidal ideation or psychosis.⁴ Mania or hypomania are potential complications of sleep loss for patients with bipolar or unipolar depression. In a review, Oliwenstein⁶ suggested that rates of total sleep deprivation-induced mania are likely to be similar to or less than those reported for antidepressants. Because sleep deprivation can induce seizures, this therapy is contraindicated for patients with epilepsy or those at risk for seizures.⁴

Researchers have successfully explored strategies to reduce the rate of depressive relapse after sleep deprivation, including coadministering light therapy, antidepressants, lithium (particularly for bipolar depression), and sleep-phase advance.⁴ Sleep-phase advance involves shifting the sleep-wake schedule to a very early sleep time and wake-up time (such as 5 PM to midnight) for 1 day, and then pushing back this schedule by 1 or 2 hours each day until the patient is returned to a “normal” sleep schedule (such as 10 PM to 5 AM). Researchers have demonstrated that sleep-phase advance can have antidepressant effects.⁷

TREATMENT: Sleep manipulation

Ms. W is continued on fluoxetine, 80 mg/d. We opt for a trial of partial sleep deprivation and sleep-phase advance for Ms. W because of the severity of her depression, her multiple ineffective or poorly tolerated medication trials, and limited benefit from ECT. This treatment involves instituting partial sleep deprivation the first night and subsequently advancing her sleep phase over the next several days (Table 1).

Although she is sleepy the morning after partial sleep deprivation, Ms. W reports a marked improvement in her mood, decline in hopelessness, and absence of suicidal ideation. She continues the sleep-phase advance protocol for the next 3 nights and participates in cognitive-behavioral therapy groups and ward activities. Psychiatric unit staff support her continued wakefulness during sleep manipulation. Because Ms. W had previously responded to antidepressant augmentation with an atypical antipsychotic we add aripiprazole and titrate the dosage to 7.5 mg/d. We also continue fluoxetine, 80 mg/d, and add trazodone, 100 mg at bedtime, and hydroxyzine, 25 mg as needed.

Table 1

Ms. W’s chronotherapy protocol: Hours permitted for sleep*

The authors’ observations

Chronotherapy incorporates manipulations of the sleep/wake cycle such as sleep deprivation and dark or light therapy. It may use combinations of interventions to generate and sustain a response in patients with depression. In a 4-week pilot study, Moscovici et al⁸ employed a regimen of late partial sleep deprivation, light, and sleep-phase advance to generate and maintain an anti depressant response in 12 patients. Benedetti et al⁹ used a similar regimen plus lithium to successfully treat bipolar depression and sleep-phase advance to continue that response in 50% of patients for 3 months.

Circadian rhythms affect the function of serotonin (5-HT), norepinephrine, and dopamine.^9,10 In a manner similar to antidepressant medications, sleep deprivation may up-regulate or otherwise alter these neurotransmitters’ function. In animals, sleep deprivation increases serotonin function.¹¹ Several hypothetical mechanisms of action for sleep deprivation and other types of chronotherapies have been suggested (Table 2).^11-14

Chronotherapies may affect function in brain pathways, as demonstrated by neuroimaging with positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Depression has been associated with increased or decreased brain activity measured by PET or fMRI in regions of the limbic cortex (cingulate and anterior cingulate) and frontal cortex.¹²

Wu et al¹³ examined patients treated for depression with medication and total sleep deprivation therapy. Response to treatment was associated with increased function in the cingulate, anterior cingulate, and medial prefrontal cortex as measured by PET. In contrast, mood improvement was associated with reduced baseline activity in the left medial prefrontal cortex, left frontal pole, and right lateral prefrontal cortex.

Researchers have noted the convergence of sleep-wake rhythms and abnormalities seen in depression and the subsequent link with improved sleep-wake cycles related to depression remission. Bunney and Potkin¹⁴ note the powerful effect of zeitgebers—environmental agents that reset the body’s internal clock. They suggested that sleep deprivation may affect the function of “master clock” genes involved in controlling the biological clock. These effects on the suprachiasmatic nucleus hypothalamic pacemaker may improve mood by altering control of genetic expression through chromatin remodeling of this master clock circuit.

Certain factors may increase the likelihood that a patient may respond to chronotherapy (Table 3).^9,15-17

Table 2

Sleep deprivation for depression: Possible mechanisms

Table 3

Factors that suggest a patient might respond to chronotherapy

OUTCOME: Lasting improvement

Ms. W’s mood improvement is sustained during her week-long hospitalization. At discharge she is hopeful about the future and does not have thoughts of suicide.

At subsequent outpatient visits up to 4 months after discharge, her depressive symptoms remain improved. Patient Health Questionnaire scores indicate mild depression, but Ms. W is not suicidal. She maintains a sleep schedule of 10 PM to 6:30 AM and undergoes 10,000 lux bright light therapy, which she began shortly after discharge, for 30 minutes every morning. She works more productively in psychotherapy, focusing on her eating disorder and anxiety.

Related resource

• Wu JC, Kelsoe JR, Schachat C, et al. Rapid and sustained antidepressant response with sleep deprivation and chronotherapy in bipolar disorder. Biol Psychiatry. 2009; 66(3): 298-301.

Drug brand names

• Aripiprazole • Abilify
• Atomoxetine • Strattera
• Bupropion • Wellbutrin
• Buspirone • BuSpar
• Citalopram • Celexa
• Clomipramine • Anafranil
• Clonazepam • Klonopin
• Duloxetine • Cymbalta
• Fluoxetine • Prozac
• Gabapentin • Neurontin
• Hydrocodone/APAP • Vicodin
• Hydroxyzine • Atarax, Vistaril
• Leuprolide • Lupron
• Liothyronine • Cytomel
• Lithium • Eskalith, Lithobid
• Lorazepam • Ativan
• Nortriptyline • Aventyl
• Paroxetine • Paxil
• Risperidone • Risperdal, Risperdal Consta
• Trazodone • Desyrel
• Venlafaxine XR • Effexor XR
• Zolpidem • Ambien

Disclosures

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

CASE: Refractory depression

Ms. W, age 38, is brought to the emergency department after her son finds her unresponsive and calls 911. Suffering from worsening depression, she wrote a note telling her children goodbye, and overdosed on zolpidem from an old prescription and her daughter’s opioids. After being evaluated and medically cleared in the emergency department, Ms. W was admitted to the psychiatric unit.

Ms. W has a history of recurrent major depressive disorder that developed after she was sexually abused by a relative as a teen. She also has bulimia nervosa, alcohol dependence, and posttraumatic stress disorder. She was hospitalized twice for depression and suicidality but had not previously attempted suicide. In the mid-to-late 1990s, she had trials of paroxetine, clomipramine, lithium, and bupropion.

She was seen regularly in our outpatient psychiatry clinic for medication management and supportive psychotherapy. Since being followed in our clinic starting in early 2005, she has had the following medication trials:

• fluoxetine, citalopram, venlafaxine XR, and duloxetine for depression
• atomoxetine, buspirone, liothyronine, risperidone, and aripiprazole for antidepressant augmentation
• lorazepam, clonazepam, and gabapentin for anxiety
• zolpidem and trazodone for insomnia
• nortriptyline for migraine headache prophylaxis.

Some medications were not tolerated, primarily because of increased anxiety. Those that were tolerated were adequate trials in terms of dose titration and length. High-dose fluoxetine (80 mg/d) augmented by risperidone (0.375 to 0.5 mg/d) produced the most reliable and significant improvement.

Ms. W had 2 courses of electroconvulsive therapy (ECT) totaling 30 treatments—most recently in 2007—that resulted in significant memory loss with limited benefit. Premenstrual worsening of depression and suicidality were noted. In collaboration with her gynecologist, Ms. W was treated with a 3-month trial of leuprolide to suppress her ovarian axis, which was helpful. In 2008 she underwent bilateral oophorectomy. She has not had symptoms of mood elevation or psychosis. Family history includes schizophrenia, depression, anxiety, and alcoholism.

In the months before hospitalization, Ms. W had been increasingly depressed and intermittently suicidal, although she did not endorse a specific plan or intention to harm herself because she was concerned about the impact suicide would have on her children. Weight gain with risperidone had reactivated body image issues, so Ms. W stopped taking this medication 2 weeks before hospitalization. Her depression became worse, and she began using her husband’s hydrocodone/acetaminophen prescription.

The authors’ observations

Approximately 40% of patients with major depression fail to respond to an initial antidepressant trial.¹ An additional 50% of these patients will be treatment-resistant to a subsequent antidepressant.¹ Patients may be progressively less likely to respond to additional medication trials.²

One of the most rapid-acting and effective treatments for unipolar and bipolar depression is sleep deprivation. Wirz-Justice et al³ found total or partial sleep deprivation during the second half of the night induced rapid depression remission. Response rates range from 40% to 60% over hours to days.⁴ Sleep deprivation also can reduce suicidality in patients with seasonal depression.⁵ This treatment has not been widely employed, however, because up to 80% of patients who undergo sleep deprivation experience rapid and significant depressive relapse.⁴

Sleep deprivation usually is well tolerated. Potential side effects include:

• headache
• gastrointestinal upset
• fatigue
• cognitive impairment.

Less often, patients report worsening of depressive symptoms and, rarely, suicidal ideation or psychosis.⁴ Mania or hypomania are potential complications of sleep loss for patients with bipolar or unipolar depression. In a review, Oliwenstein⁶ suggested that rates of total sleep deprivation-induced mania are likely to be similar to or less than those reported for antidepressants. Because sleep deprivation can induce seizures, this therapy is contraindicated for patients with epilepsy or those at risk for seizures.⁴

Researchers have successfully explored strategies to reduce the rate of depressive relapse after sleep deprivation, including coadministering light therapy, antidepressants, lithium (particularly for bipolar depression), and sleep-phase advance.⁴ Sleep-phase advance involves shifting the sleep-wake schedule to a very early sleep time and wake-up time (such as 5 PM to midnight) for 1 day, and then pushing back this schedule by 1 or 2 hours each day until the patient is returned to a “normal” sleep schedule (such as 10 PM to 5 AM). Researchers have demonstrated that sleep-phase advance can have antidepressant effects.⁷

TREATMENT: Sleep manipulation

Ms. W is continued on fluoxetine, 80 mg/d. We opt for a trial of partial sleep deprivation and sleep-phase advance for Ms. W because of the severity of her depression, her multiple ineffective or poorly tolerated medication trials, and limited benefit from ECT. This treatment involves instituting partial sleep deprivation the first night and subsequently advancing her sleep phase over the next several days (Table 1).

Although she is sleepy the morning after partial sleep deprivation, Ms. W reports a marked improvement in her mood, decline in hopelessness, and absence of suicidal ideation. She continues the sleep-phase advance protocol for the next 3 nights and participates in cognitive-behavioral therapy groups and ward activities. Psychiatric unit staff support her continued wakefulness during sleep manipulation. Because Ms. W had previously responded to antidepressant augmentation with an atypical antipsychotic we add aripiprazole and titrate the dosage to 7.5 mg/d. We also continue fluoxetine, 80 mg/d, and add trazodone, 100 mg at bedtime, and hydroxyzine, 25 mg as needed.

Table 1

Ms. W’s chronotherapy protocol: Hours permitted for sleep*

The authors’ observations

Chronotherapy incorporates manipulations of the sleep/wake cycle such as sleep deprivation and dark or light therapy. It may use combinations of interventions to generate and sustain a response in patients with depression. In a 4-week pilot study, Moscovici et al⁸ employed a regimen of late partial sleep deprivation, light, and sleep-phase advance to generate and maintain an anti depressant response in 12 patients. Benedetti et al⁹ used a similar regimen plus lithium to successfully treat bipolar depression and sleep-phase advance to continue that response in 50% of patients for 3 months.

Circadian rhythms affect the function of serotonin (5-HT), norepinephrine, and dopamine.^9,10 In a manner similar to antidepressant medications, sleep deprivation may up-regulate or otherwise alter these neurotransmitters’ function. In animals, sleep deprivation increases serotonin function.¹¹ Several hypothetical mechanisms of action for sleep deprivation and other types of chronotherapies have been suggested (Table 2).^11-14

Chronotherapies may affect function in brain pathways, as demonstrated by neuroimaging with positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Depression has been associated with increased or decreased brain activity measured by PET or fMRI in regions of the limbic cortex (cingulate and anterior cingulate) and frontal cortex.¹²

Wu et al¹³ examined patients treated for depression with medication and total sleep deprivation therapy. Response to treatment was associated with increased function in the cingulate, anterior cingulate, and medial prefrontal cortex as measured by PET. In contrast, mood improvement was associated with reduced baseline activity in the left medial prefrontal cortex, left frontal pole, and right lateral prefrontal cortex.

Researchers have noted the convergence of sleep-wake rhythms and abnormalities seen in depression and the subsequent link with improved sleep-wake cycles related to depression remission. Bunney and Potkin¹⁴ note the powerful effect of zeitgebers—environmental agents that reset the body’s internal clock. They suggested that sleep deprivation may affect the function of “master clock” genes involved in controlling the biological clock. These effects on the suprachiasmatic nucleus hypothalamic pacemaker may improve mood by altering control of genetic expression through chromatin remodeling of this master clock circuit.

Certain factors may increase the likelihood that a patient may respond to chronotherapy (Table 3).^9,15-17

Table 2

Sleep deprivation for depression: Possible mechanisms

Table 3

Factors that suggest a patient might respond to chronotherapy

OUTCOME: Lasting improvement

Ms. W’s mood improvement is sustained during her week-long hospitalization. At discharge she is hopeful about the future and does not have thoughts of suicide.

At subsequent outpatient visits up to 4 months after discharge, her depressive symptoms remain improved. Patient Health Questionnaire scores indicate mild depression, but Ms. W is not suicidal. She maintains a sleep schedule of 10 PM to 6:30 AM and undergoes 10,000 lux bright light therapy, which she began shortly after discharge, for 30 minutes every morning. She works more productively in psychotherapy, focusing on her eating disorder and anxiety.

Related resource

• Wu JC, Kelsoe JR, Schachat C, et al. Rapid and sustained antidepressant response with sleep deprivation and chronotherapy in bipolar disorder. Biol Psychiatry. 2009; 66(3): 298-301.

Drug brand names

• Aripiprazole • Abilify
• Atomoxetine • Strattera
• Bupropion • Wellbutrin
• Buspirone • BuSpar
• Citalopram • Celexa
• Clomipramine • Anafranil
• Clonazepam • Klonopin
• Duloxetine • Cymbalta
• Fluoxetine • Prozac
• Gabapentin • Neurontin
• Hydrocodone/APAP • Vicodin
• Hydroxyzine • Atarax, Vistaril
• Leuprolide • Lupron
• Liothyronine • Cytomel
• Lithium • Eskalith, Lithobid
• Lorazepam • Ativan
• Nortriptyline • Aventyl
• Paroxetine • Paxil
• Risperidone • Risperdal, Risperdal Consta
• Trazodone • Desyrel
• Venlafaxine XR • Effexor XR
• Zolpidem • Ambien

Disclosures

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

CASE: Refractory depression

Ms. W, age 38, is brought to the emergency department after her son finds her unresponsive and calls 911. Suffering from worsening depression, she wrote a note telling her children goodbye, and overdosed on zolpidem from an old prescription and her daughter’s opioids. After being evaluated and medically cleared in the emergency department, Ms. W was admitted to the psychiatric unit.

Ms. W has a history of recurrent major depressive disorder that developed after she was sexually abused by a relative as a teen. She also has bulimia nervosa, alcohol dependence, and posttraumatic stress disorder. She was hospitalized twice for depression and suicidality but had not previously attempted suicide. In the mid-to-late 1990s, she had trials of paroxetine, clomipramine, lithium, and bupropion.

She was seen regularly in our outpatient psychiatry clinic for medication management and supportive psychotherapy. Since being followed in our clinic starting in early 2005, she has had the following medication trials:

• fluoxetine, citalopram, venlafaxine XR, and duloxetine for depression
• atomoxetine, buspirone, liothyronine, risperidone, and aripiprazole for antidepressant augmentation
• lorazepam, clonazepam, and gabapentin for anxiety
• zolpidem and trazodone for insomnia
• nortriptyline for migraine headache prophylaxis.

Some medications were not tolerated, primarily because of increased anxiety. Those that were tolerated were adequate trials in terms of dose titration and length. High-dose fluoxetine (80 mg/d) augmented by risperidone (0.375 to 0.5 mg/d) produced the most reliable and significant improvement.

Ms. W had 2 courses of electroconvulsive therapy (ECT) totaling 30 treatments—most recently in 2007—that resulted in significant memory loss with limited benefit. Premenstrual worsening of depression and suicidality were noted. In collaboration with her gynecologist, Ms. W was treated with a 3-month trial of leuprolide to suppress her ovarian axis, which was helpful. In 2008 she underwent bilateral oophorectomy. She has not had symptoms of mood elevation or psychosis. Family history includes schizophrenia, depression, anxiety, and alcoholism.

In the months before hospitalization, Ms. W had been increasingly depressed and intermittently suicidal, although she did not endorse a specific plan or intention to harm herself because she was concerned about the impact suicide would have on her children. Weight gain with risperidone had reactivated body image issues, so Ms. W stopped taking this medication 2 weeks before hospitalization. Her depression became worse, and she began using her husband’s hydrocodone/acetaminophen prescription.

The authors’ observations

Approximately 40% of patients with major depression fail to respond to an initial antidepressant trial.¹ An additional 50% of these patients will be treatment-resistant to a subsequent antidepressant.¹ Patients may be progressively less likely to respond to additional medication trials.²

One of the most rapid-acting and effective treatments for unipolar and bipolar depression is sleep deprivation. Wirz-Justice et al³ found total or partial sleep deprivation during the second half of the night induced rapid depression remission. Response rates range from 40% to 60% over hours to days.⁴ Sleep deprivation also can reduce suicidality in patients with seasonal depression.⁵ This treatment has not been widely employed, however, because up to 80% of patients who undergo sleep deprivation experience rapid and significant depressive relapse.⁴

Sleep deprivation usually is well tolerated. Potential side effects include:

• headache
• gastrointestinal upset
• fatigue
• cognitive impairment.

Less often, patients report worsening of depressive symptoms and, rarely, suicidal ideation or psychosis.⁴ Mania or hypomania are potential complications of sleep loss for patients with bipolar or unipolar depression. In a review, Oliwenstein⁶ suggested that rates of total sleep deprivation-induced mania are likely to be similar to or less than those reported for antidepressants. Because sleep deprivation can induce seizures, this therapy is contraindicated for patients with epilepsy or those at risk for seizures.⁴

Researchers have successfully explored strategies to reduce the rate of depressive relapse after sleep deprivation, including coadministering light therapy, antidepressants, lithium (particularly for bipolar depression), and sleep-phase advance.⁴ Sleep-phase advance involves shifting the sleep-wake schedule to a very early sleep time and wake-up time (such as 5 PM to midnight) for 1 day, and then pushing back this schedule by 1 or 2 hours each day until the patient is returned to a “normal” sleep schedule (such as 10 PM to 5 AM). Researchers have demonstrated that sleep-phase advance can have antidepressant effects.⁷

TREATMENT: Sleep manipulation

Ms. W is continued on fluoxetine, 80 mg/d. We opt for a trial of partial sleep deprivation and sleep-phase advance for Ms. W because of the severity of her depression, her multiple ineffective or poorly tolerated medication trials, and limited benefit from ECT. This treatment involves instituting partial sleep deprivation the first night and subsequently advancing her sleep phase over the next several days (Table 1).

Although she is sleepy the morning after partial sleep deprivation, Ms. W reports a marked improvement in her mood, decline in hopelessness, and absence of suicidal ideation. She continues the sleep-phase advance protocol for the next 3 nights and participates in cognitive-behavioral therapy groups and ward activities. Psychiatric unit staff support her continued wakefulness during sleep manipulation. Because Ms. W had previously responded to antidepressant augmentation with an atypical antipsychotic we add aripiprazole and titrate the dosage to 7.5 mg/d. We also continue fluoxetine, 80 mg/d, and add trazodone, 100 mg at bedtime, and hydroxyzine, 25 mg as needed.

Table 1

Ms. W’s chronotherapy protocol: Hours permitted for sleep*

The authors’ observations

Chronotherapy incorporates manipulations of the sleep/wake cycle such as sleep deprivation and dark or light therapy. It may use combinations of interventions to generate and sustain a response in patients with depression. In a 4-week pilot study, Moscovici et al⁸ employed a regimen of late partial sleep deprivation, light, and sleep-phase advance to generate and maintain an anti depressant response in 12 patients. Benedetti et al⁹ used a similar regimen plus lithium to successfully treat bipolar depression and sleep-phase advance to continue that response in 50% of patients for 3 months.

Circadian rhythms affect the function of serotonin (5-HT), norepinephrine, and dopamine.^9,10 In a manner similar to antidepressant medications, sleep deprivation may up-regulate or otherwise alter these neurotransmitters’ function. In animals, sleep deprivation increases serotonin function.¹¹ Several hypothetical mechanisms of action for sleep deprivation and other types of chronotherapies have been suggested (Table 2).^11-14

Chronotherapies may affect function in brain pathways, as demonstrated by neuroimaging with positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Depression has been associated with increased or decreased brain activity measured by PET or fMRI in regions of the limbic cortex (cingulate and anterior cingulate) and frontal cortex.¹²

Wu et al¹³ examined patients treated for depression with medication and total sleep deprivation therapy. Response to treatment was associated with increased function in the cingulate, anterior cingulate, and medial prefrontal cortex as measured by PET. In contrast, mood improvement was associated with reduced baseline activity in the left medial prefrontal cortex, left frontal pole, and right lateral prefrontal cortex.

Researchers have noted the convergence of sleep-wake rhythms and abnormalities seen in depression and the subsequent link with improved sleep-wake cycles related to depression remission. Bunney and Potkin¹⁴ note the powerful effect of zeitgebers—environmental agents that reset the body’s internal clock. They suggested that sleep deprivation may affect the function of “master clock” genes involved in controlling the biological clock. These effects on the suprachiasmatic nucleus hypothalamic pacemaker may improve mood by altering control of genetic expression through chromatin remodeling of this master clock circuit.

Certain factors may increase the likelihood that a patient may respond to chronotherapy (Table 3).^9,15-17

Table 2

Sleep deprivation for depression: Possible mechanisms

Table 3

Factors that suggest a patient might respond to chronotherapy

OUTCOME: Lasting improvement

Ms. W’s mood improvement is sustained during her week-long hospitalization. At discharge she is hopeful about the future and does not have thoughts of suicide.

At subsequent outpatient visits up to 4 months after discharge, her depressive symptoms remain improved. Patient Health Questionnaire scores indicate mild depression, but Ms. W is not suicidal. She maintains a sleep schedule of 10 PM to 6:30 AM and undergoes 10,000 lux bright light therapy, which she began shortly after discharge, for 30 minutes every morning. She works more productively in psychotherapy, focusing on her eating disorder and anxiety.

Related resource

• Wu JC, Kelsoe JR, Schachat C, et al. Rapid and sustained antidepressant response with sleep deprivation and chronotherapy in bipolar disorder. Biol Psychiatry. 2009; 66(3): 298-301.

Drug brand names

• Aripiprazole • Abilify
• Atomoxetine • Strattera
• Bupropion • Wellbutrin
• Buspirone • BuSpar
• Citalopram • Celexa
• Clomipramine • Anafranil
• Clonazepam • Klonopin
• Duloxetine • Cymbalta
• Fluoxetine • Prozac
• Gabapentin • Neurontin
• Hydrocodone/APAP • Vicodin
• Hydroxyzine • Atarax, Vistaril
• Leuprolide • Lupron
• Liothyronine • Cytomel
• Lithium • Eskalith, Lithobid
• Lorazepam • Ativan
• Nortriptyline • Aventyl
• Paroxetine • Paxil
• Risperidone • Risperdal, Risperdal Consta
• Trazodone • Desyrel
• Venlafaxine XR • Effexor XR
• Zolpidem • Ambien

Disclosures

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

[email protected]

When presented with an overweight child who has hypertension, collect a detailed history, including a 24-hour food-intake history.

Also assess the child's nutritional habits, such as number of fast-food items typically eaten per week and number of family dinners.

Ask about the fluids these children generally consume. For instance, do they drink any caloric beverages other than low-fat milk?

Take an exercise history. Inquire how many hours per day the child is exposed to television, video games, and other media.

Social interaction can be particularly important with an overweight child. Ask if the child has been teased or bullied at home, in school, or elsewhere in the community.

Next ask the parent(s) and patient what they know about high blood pressure. Also inquire about a family history of hypertension.

Confirm any elevation in the child's blood pressure during a physical examination. If the patient has severe hypertension, it is usually time to refer the child to a specialist.

If the child has hypertension for three consecutive monthly visits, further evaluation with blood work is appropriate. Order a complete metabolic panel, urinalysis, and fasting lipid panel. Urinalysis, for example, is useful as a screen for type 2 diabetes.

On a full review of systems, identify other morbidities associated with obesity and perform appropriate tests.

For instance, the child with daytime sleepiness and snoring may require a sleep study to identify obstructive sleep apnea.

In addition, if liver function tests are elevated, a pediatric ultrasound exam can identify a fatty liver.

You can also order an electrocardiogram to identify heart pathology and refer the child if the findings are abnormal.

Many families request thyroid testing for an overweight child. Full thyroid function tests are not cost effective and need not be done. A thyroid-stimulating hormone test should suffice.

As for behavioral counseling, at the Cleveland Clinic Children's Hospital, we recommend our “5 to GO!” messaging, in which children are told to eat 5-a-day fruits and veggies; give 4 compliments a day to anyone they encounter, including other kids, and get 4 compliments a day from anyone; consume 3 dairy products a day; engage in no more than 2 hours of media/TV time a day; drink 0 sugar-sweetened beverages, and go!

For teenagers, we aim for 4 dairy/calcium servings and 3 compliments a day (not that they need fewer compliments, but they do need more calcium than the under age 10 crowd).

The key is to follow patients monthly. Slow, steady change—with positive motivation tailored to each family—works better than trying to do everything at once.

Follow up, follow up, and follow up—with a lot of cheerleading!

Patient education is also essential. Help patients and their families figure out how to cook a no-added-salt diet, how to shop the periphery of a grocery store where the fresh produce is located, and how to build physical activity and exercise into the family's daily plan.

Consider a weight management program such as our Fit Youth Program. Patients and families who participate in this 12-week program at the Cleveland Clinic receive group counseling sessions led by a psychologist in combination with a pediatrician, a dietitian, and an exercise physiologist.

Multidisciplinary interventions such as this one can accomplish modest weight loss versus progression toward 30 pounds of weight gain per year, as occurs in many of our children who do not receive effective treatment.

[email protected]

When presented with an overweight child who has hypertension, collect a detailed history, including a 24-hour food-intake history.

Also assess the child's nutritional habits, such as number of fast-food items typically eaten per week and number of family dinners.

Ask about the fluids these children generally consume. For instance, do they drink any caloric beverages other than low-fat milk?

Take an exercise history. Inquire how many hours per day the child is exposed to television, video games, and other media.

Social interaction can be particularly important with an overweight child. Ask if the child has been teased or bullied at home, in school, or elsewhere in the community.

Next ask the parent(s) and patient what they know about high blood pressure. Also inquire about a family history of hypertension.

Confirm any elevation in the child's blood pressure during a physical examination. If the patient has severe hypertension, it is usually time to refer the child to a specialist.

If the child has hypertension for three consecutive monthly visits, further evaluation with blood work is appropriate. Order a complete metabolic panel, urinalysis, and fasting lipid panel. Urinalysis, for example, is useful as a screen for type 2 diabetes.

On a full review of systems, identify other morbidities associated with obesity and perform appropriate tests.

For instance, the child with daytime sleepiness and snoring may require a sleep study to identify obstructive sleep apnea.

In addition, if liver function tests are elevated, a pediatric ultrasound exam can identify a fatty liver.

You can also order an electrocardiogram to identify heart pathology and refer the child if the findings are abnormal.

Many families request thyroid testing for an overweight child. Full thyroid function tests are not cost effective and need not be done. A thyroid-stimulating hormone test should suffice.

As for behavioral counseling, at the Cleveland Clinic Children's Hospital, we recommend our “5 to GO!” messaging, in which children are told to eat 5-a-day fruits and veggies; give 4 compliments a day to anyone they encounter, including other kids, and get 4 compliments a day from anyone; consume 3 dairy products a day; engage in no more than 2 hours of media/TV time a day; drink 0 sugar-sweetened beverages, and go!

For teenagers, we aim for 4 dairy/calcium servings and 3 compliments a day (not that they need fewer compliments, but they do need more calcium than the under age 10 crowd).

The key is to follow patients monthly. Slow, steady change—with positive motivation tailored to each family—works better than trying to do everything at once.

Follow up, follow up, and follow up—with a lot of cheerleading!

Patient education is also essential. Help patients and their families figure out how to cook a no-added-salt diet, how to shop the periphery of a grocery store where the fresh produce is located, and how to build physical activity and exercise into the family's daily plan.

Consider a weight management program such as our Fit Youth Program. Patients and families who participate in this 12-week program at the Cleveland Clinic receive group counseling sessions led by a psychologist in combination with a pediatrician, a dietitian, and an exercise physiologist.

Multidisciplinary interventions such as this one can accomplish modest weight loss versus progression toward 30 pounds of weight gain per year, as occurs in many of our children who do not receive effective treatment.

[email protected]

When presented with an overweight child who has hypertension, collect a detailed history, including a 24-hour food-intake history.

Also assess the child's nutritional habits, such as number of fast-food items typically eaten per week and number of family dinners.

Ask about the fluids these children generally consume. For instance, do they drink any caloric beverages other than low-fat milk?

Take an exercise history. Inquire how many hours per day the child is exposed to television, video games, and other media.

Social interaction can be particularly important with an overweight child. Ask if the child has been teased or bullied at home, in school, or elsewhere in the community.

Next ask the parent(s) and patient what they know about high blood pressure. Also inquire about a family history of hypertension.

Confirm any elevation in the child's blood pressure during a physical examination. If the patient has severe hypertension, it is usually time to refer the child to a specialist.

If the child has hypertension for three consecutive monthly visits, further evaluation with blood work is appropriate. Order a complete metabolic panel, urinalysis, and fasting lipid panel. Urinalysis, for example, is useful as a screen for type 2 diabetes.

On a full review of systems, identify other morbidities associated with obesity and perform appropriate tests.

For instance, the child with daytime sleepiness and snoring may require a sleep study to identify obstructive sleep apnea.

In addition, if liver function tests are elevated, a pediatric ultrasound exam can identify a fatty liver.

You can also order an electrocardiogram to identify heart pathology and refer the child if the findings are abnormal.

Many families request thyroid testing for an overweight child. Full thyroid function tests are not cost effective and need not be done. A thyroid-stimulating hormone test should suffice.

As for behavioral counseling, at the Cleveland Clinic Children's Hospital, we recommend our “5 to GO!” messaging, in which children are told to eat 5-a-day fruits and veggies; give 4 compliments a day to anyone they encounter, including other kids, and get 4 compliments a day from anyone; consume 3 dairy products a day; engage in no more than 2 hours of media/TV time a day; drink 0 sugar-sweetened beverages, and go!

For teenagers, we aim for 4 dairy/calcium servings and 3 compliments a day (not that they need fewer compliments, but they do need more calcium than the under age 10 crowd).

The key is to follow patients monthly. Slow, steady change—with positive motivation tailored to each family—works better than trying to do everything at once.

Follow up, follow up, and follow up—with a lot of cheerleading!

Patient education is also essential. Help patients and their families figure out how to cook a no-added-salt diet, how to shop the periphery of a grocery store where the fresh produce is located, and how to build physical activity and exercise into the family's daily plan.

Consider a weight management program such as our Fit Youth Program. Patients and families who participate in this 12-week program at the Cleveland Clinic receive group counseling sessions led by a psychologist in combination with a pediatrician, a dietitian, and an exercise physiologist.

Multidisciplinary interventions such as this one can accomplish modest weight loss versus progression toward 30 pounds of weight gain per year, as occurs in many of our children who do not receive effective treatment.

A hospitalist-led initiative to boost the implementation of glycemic controls has exceeded initial goals at an Alabama hospital, an early sign of success for the SHM-sponsored pilot program.

Steven C. Smith, MD, FHM, medical director of hospitalist services at Healthcare Authority for Medical West in Bessemer, Ala., says that after the Glycemic Control Mentored Implementation (GCMI) program was put in place earlier this year, his group set a two-week goal of 5% utilization of the program's evidence-based order set. He also set a three-month goal of 25% compliance with the order set.

"Much to my surprise, we achieved 16% utilization at two weeks," Dr. Smith says, adding that three-month data are still being tabulated. "The involvement by SHM is what made the difference. Being able to tell people on the medical staff that this is part of a national-level QI project, we're participating in something bigger—that made a big difference in getting people interested in the order set."

Representatives from several of the 30 pilot sites have reported similar success in the early stages of the yearlong project. Among other issues, the GCMI program tackles subcutaneous insulin protocols, transition from subcutaneous to infusion, care coordination, improving follow-up care, and hypoglycemia management.

Although institutions entered the program in April, Dr. Smith and his colleagues didn't begin their formal mentoring relationship until July. Since then, his HM group has stayed in touch with program mentors through teleconferences and direct e-mail exchanges. The service also has access to a data-aggregation system through the Yale Center for Medical Informatics, which encourages more attention and utilization of newly created order sets.

"We are in the process of collecting data from a period of about one year prior to our project and comparing that to data since the implementation of our order set," Dr. Smith says. The analysis "will allow us, and our mentor, to tailor our efforts to our particular institution in an ongoing fashion. The ongoing measures of our success with this project will include outcomes measures like length of stay, cost of stay, mortality and morbidity, ICU length of stay, ventilator days, and others."

A hospitalist-led initiative to boost the implementation of glycemic controls has exceeded initial goals at an Alabama hospital, an early sign of success for the SHM-sponsored pilot program.

Steven C. Smith, MD, FHM, medical director of hospitalist services at Healthcare Authority for Medical West in Bessemer, Ala., says that after the Glycemic Control Mentored Implementation (GCMI) program was put in place earlier this year, his group set a two-week goal of 5% utilization of the program's evidence-based order set. He also set a three-month goal of 25% compliance with the order set.

"Much to my surprise, we achieved 16% utilization at two weeks," Dr. Smith says, adding that three-month data are still being tabulated. "The involvement by SHM is what made the difference. Being able to tell people on the medical staff that this is part of a national-level QI project, we're participating in something bigger—that made a big difference in getting people interested in the order set."

Representatives from several of the 30 pilot sites have reported similar success in the early stages of the yearlong project. Among other issues, the GCMI program tackles subcutaneous insulin protocols, transition from subcutaneous to infusion, care coordination, improving follow-up care, and hypoglycemia management.

Although institutions entered the program in April, Dr. Smith and his colleagues didn't begin their formal mentoring relationship until July. Since then, his HM group has stayed in touch with program mentors through teleconferences and direct e-mail exchanges. The service also has access to a data-aggregation system through the Yale Center for Medical Informatics, which encourages more attention and utilization of newly created order sets.

"We are in the process of collecting data from a period of about one year prior to our project and comparing that to data since the implementation of our order set," Dr. Smith says. The analysis "will allow us, and our mentor, to tailor our efforts to our particular institution in an ongoing fashion. The ongoing measures of our success with this project will include outcomes measures like length of stay, cost of stay, mortality and morbidity, ICU length of stay, ventilator days, and others."

A hospitalist-led initiative to boost the implementation of glycemic controls has exceeded initial goals at an Alabama hospital, an early sign of success for the SHM-sponsored pilot program.

Steven C. Smith, MD, FHM, medical director of hospitalist services at Healthcare Authority for Medical West in Bessemer, Ala., says that after the Glycemic Control Mentored Implementation (GCMI) program was put in place earlier this year, his group set a two-week goal of 5% utilization of the program's evidence-based order set. He also set a three-month goal of 25% compliance with the order set.

"Much to my surprise, we achieved 16% utilization at two weeks," Dr. Smith says, adding that three-month data are still being tabulated. "The involvement by SHM is what made the difference. Being able to tell people on the medical staff that this is part of a national-level QI project, we're participating in something bigger—that made a big difference in getting people interested in the order set."

Representatives from several of the 30 pilot sites have reported similar success in the early stages of the yearlong project. Among other issues, the GCMI program tackles subcutaneous insulin protocols, transition from subcutaneous to infusion, care coordination, improving follow-up care, and hypoglycemia management.

Although institutions entered the program in April, Dr. Smith and his colleagues didn't begin their formal mentoring relationship until July. Since then, his HM group has stayed in touch with program mentors through teleconferences and direct e-mail exchanges. The service also has access to a data-aggregation system through the Yale Center for Medical Informatics, which encourages more attention and utilization of newly created order sets.

"We are in the process of collecting data from a period of about one year prior to our project and comparing that to data since the implementation of our order set," Dr. Smith says. The analysis "will allow us, and our mentor, to tailor our efforts to our particular institution in an ongoing fashion. The ongoing measures of our success with this project will include outcomes measures like length of stay, cost of stay, mortality and morbidity, ICU length of stay, ventilator days, and others."

Clinical question: What factors are associated with methicillin-resistant Staphylococcus aureus (MRSA) carriage at hospital discharge to home health care, prolonged MRSA colonization, and MRSA transmission to household contacts?

Background: Previous studies have reported prolonged colonization with hospital-acquired MRSA after discharge, as well as transmission of MRSA to household contacts. However, the rates and risk factors for MRSA carriage and transmission are unknown.

Study design: Multicenter prospective cohort.

Setting: Home-health-care system associated with 47 public teaching hospitals in France.

Synopsis: More than 1,500 hospitalized adult patients with planned discharge to home health care were screened for MRSA colonization, and 12.7% were MRSA-positive by nasal or skin lesion swab.

Factors independently associated with MRSA carriage at hospital discharge were chronic skin lesions, older age, longer duration of hospitalization, and neurologic and cardiovascular primary diagnoses.

Surveillance sampling for up to one year showed that approximately half of these patients had clearance of MRSA, with a median time to clearance of 282 days. Lack of self-sufficiency in daily activities was associated with persistent MRSA carriage.

Nineteen percent of household contacts acquired MRSA during the study period. Risks included older age and providing healthcare to the index patient.

Bottom line: Hospital-acquired MRSA colonization is prevalent at discharge to home health settings, is frequently prolonged, and commonly results in transmission to household contacts, particularly those providing healthcare to the index patient.

Citation: Lucet JC, Paoletti X, Demontpion C, et al. Carriage of methicillin-resistant Staphylococcus aureus in home care settings: prevalence, duration, and transmission to household members. Arch Intern Med. 2009;169(15):1372-1378.

—Reviewed for TH eWire by Kelly Cunningham, MD, Elizabeth Rice, MD, Eduard Vasilevskis, MD, Joshua LaBrin, MD, Kelly Sopko, MD, Shelley Ellis, MD, MPH, and Sunil Kripalani, MD, MSc, Section of Hospital Medicine, Vanderbilt University, Nashville, Tenn.

Clinical question: What factors are associated with methicillin-resistant Staphylococcus aureus (MRSA) carriage at hospital discharge to home health care, prolonged MRSA colonization, and MRSA transmission to household contacts?

Background: Previous studies have reported prolonged colonization with hospital-acquired MRSA after discharge, as well as transmission of MRSA to household contacts. However, the rates and risk factors for MRSA carriage and transmission are unknown.

Study design: Multicenter prospective cohort.

Setting: Home-health-care system associated with 47 public teaching hospitals in France.

Synopsis: More than 1,500 hospitalized adult patients with planned discharge to home health care were screened for MRSA colonization, and 12.7% were MRSA-positive by nasal or skin lesion swab.

Factors independently associated with MRSA carriage at hospital discharge were chronic skin lesions, older age, longer duration of hospitalization, and neurologic and cardiovascular primary diagnoses.

Surveillance sampling for up to one year showed that approximately half of these patients had clearance of MRSA, with a median time to clearance of 282 days. Lack of self-sufficiency in daily activities was associated with persistent MRSA carriage.

Nineteen percent of household contacts acquired MRSA during the study period. Risks included older age and providing healthcare to the index patient.

Bottom line: Hospital-acquired MRSA colonization is prevalent at discharge to home health settings, is frequently prolonged, and commonly results in transmission to household contacts, particularly those providing healthcare to the index patient.

Citation: Lucet JC, Paoletti X, Demontpion C, et al. Carriage of methicillin-resistant Staphylococcus aureus in home care settings: prevalence, duration, and transmission to household members. Arch Intern Med. 2009;169(15):1372-1378.

—Reviewed for TH eWire by Kelly Cunningham, MD, Elizabeth Rice, MD, Eduard Vasilevskis, MD, Joshua LaBrin, MD, Kelly Sopko, MD, Shelley Ellis, MD, MPH, and Sunil Kripalani, MD, MSc, Section of Hospital Medicine, Vanderbilt University, Nashville, Tenn.

Clinical question: What factors are associated with methicillin-resistant Staphylococcus aureus (MRSA) carriage at hospital discharge to home health care, prolonged MRSA colonization, and MRSA transmission to household contacts?

Background: Previous studies have reported prolonged colonization with hospital-acquired MRSA after discharge, as well as transmission of MRSA to household contacts. However, the rates and risk factors for MRSA carriage and transmission are unknown.

Study design: Multicenter prospective cohort.

Setting: Home-health-care system associated with 47 public teaching hospitals in France.

Synopsis: More than 1,500 hospitalized adult patients with planned discharge to home health care were screened for MRSA colonization, and 12.7% were MRSA-positive by nasal or skin lesion swab.

Factors independently associated with MRSA carriage at hospital discharge were chronic skin lesions, older age, longer duration of hospitalization, and neurologic and cardiovascular primary diagnoses.

Surveillance sampling for up to one year showed that approximately half of these patients had clearance of MRSA, with a median time to clearance of 282 days. Lack of self-sufficiency in daily activities was associated with persistent MRSA carriage.

Nineteen percent of household contacts acquired MRSA during the study period. Risks included older age and providing healthcare to the index patient.

Bottom line: Hospital-acquired MRSA colonization is prevalent at discharge to home health settings, is frequently prolonged, and commonly results in transmission to household contacts, particularly those providing healthcare to the index patient.

Citation: Lucet JC, Paoletti X, Demontpion C, et al. Carriage of methicillin-resistant Staphylococcus aureus in home care settings: prevalence, duration, and transmission to household members. Arch Intern Med. 2009;169(15):1372-1378.

—Reviewed for TH eWire by Kelly Cunningham, MD, Elizabeth Rice, MD, Eduard Vasilevskis, MD, Joshua LaBrin, MD, Kelly Sopko, MD, Shelley Ellis, MD, MPH, and Sunil Kripalani, MD, MSc, Section of Hospital Medicine, Vanderbilt University, Nashville, Tenn.

Improving patient discharges and reducing preventable "bounce-back" readmissions will have increasing implications for hospitals’ bottom lines—especially if proposed Medicare payment bundling reforms are adopted by Congress. Discharge improvement also enhances a hospital’s reputation with patients and providers, says Neil Gupta, MD, a hospitalist at the University of California at San Francisco.

"I think we all recognize in our daily practice that there are things we can do better for patients at discharge," Dr. Gupta says. "It's sometimes hard to get the resources and motivation to do this. But we know it could really impact patient care and make it better."

Dr. Gupta's hospital is one of 24 participating in SHM's Project BOOST (Better Outcomes for Older Adults through Safe Transitions). The mentorship program is developing a consensus and resources for best practices in patient discharges. National data show that about one in five hospitalized Medicare patients are readmitted within 30 days. While some of these readmissions are appropriate, the sheer quantity of readmissions shows room for improvement, says Dr. Gupta's colleague, Arpana Vidyarthi, MD, a hospitalist and director of quality at UCSF. "In reality, no one in the United States is doing it very well," she says.

Drs. Gupta and Vidyarthi suggest focusing your HM group's communication with primary-care physicians (PCPs): Study whether the hospitalist's messages are getting through to the PCPs and ask for their feedback. Other targets should include identifying high-risk patients, reconciling medications, scheduling the patient's first outpatient visit prior to discharge, and confirming the patient's understanding of the discharge plan.

The first step is to form an interdisciplinary team that approaches discharges as a QI project, Dr. Gupta explains. "Building that team is huge," he says. "It adds a whole new perspective." At UCSF, the team meets monthly and includes hospitalists, PCPs, staff nurses and nursing supervisors, pharmacists, care managers, and patients.

For more information about Project BOOST, visit SHM's resource room.

Improving patient discharges and reducing preventable "bounce-back" readmissions will have increasing implications for hospitals’ bottom lines—especially if proposed Medicare payment bundling reforms are adopted by Congress. Discharge improvement also enhances a hospital’s reputation with patients and providers, says Neil Gupta, MD, a hospitalist at the University of California at San Francisco.

"I think we all recognize in our daily practice that there are things we can do better for patients at discharge," Dr. Gupta says. "It's sometimes hard to get the resources and motivation to do this. But we know it could really impact patient care and make it better."

Dr. Gupta's hospital is one of 24 participating in SHM's Project BOOST (Better Outcomes for Older Adults through Safe Transitions). The mentorship program is developing a consensus and resources for best practices in patient discharges. National data show that about one in five hospitalized Medicare patients are readmitted within 30 days. While some of these readmissions are appropriate, the sheer quantity of readmissions shows room for improvement, says Dr. Gupta's colleague, Arpana Vidyarthi, MD, a hospitalist and director of quality at UCSF. "In reality, no one in the United States is doing it very well," she says.

Drs. Gupta and Vidyarthi suggest focusing your HM group's communication with primary-care physicians (PCPs): Study whether the hospitalist's messages are getting through to the PCPs and ask for their feedback. Other targets should include identifying high-risk patients, reconciling medications, scheduling the patient's first outpatient visit prior to discharge, and confirming the patient's understanding of the discharge plan.

The first step is to form an interdisciplinary team that approaches discharges as a QI project, Dr. Gupta explains. "Building that team is huge," he says. "It adds a whole new perspective." At UCSF, the team meets monthly and includes hospitalists, PCPs, staff nurses and nursing supervisors, pharmacists, care managers, and patients.

For more information about Project BOOST, visit SHM's resource room.

Improving patient discharges and reducing preventable "bounce-back" readmissions will have increasing implications for hospitals’ bottom lines—especially if proposed Medicare payment bundling reforms are adopted by Congress. Discharge improvement also enhances a hospital’s reputation with patients and providers, says Neil Gupta, MD, a hospitalist at the University of California at San Francisco.

"I think we all recognize in our daily practice that there are things we can do better for patients at discharge," Dr. Gupta says. "It's sometimes hard to get the resources and motivation to do this. But we know it could really impact patient care and make it better."

Dr. Gupta's hospital is one of 24 participating in SHM's Project BOOST (Better Outcomes for Older Adults through Safe Transitions). The mentorship program is developing a consensus and resources for best practices in patient discharges. National data show that about one in five hospitalized Medicare patients are readmitted within 30 days. While some of these readmissions are appropriate, the sheer quantity of readmissions shows room for improvement, says Dr. Gupta's colleague, Arpana Vidyarthi, MD, a hospitalist and director of quality at UCSF. "In reality, no one in the United States is doing it very well," she says.

Drs. Gupta and Vidyarthi suggest focusing your HM group's communication with primary-care physicians (PCPs): Study whether the hospitalist's messages are getting through to the PCPs and ask for their feedback. Other targets should include identifying high-risk patients, reconciling medications, scheduling the patient's first outpatient visit prior to discharge, and confirming the patient's understanding of the discharge plan.

The first step is to form an interdisciplinary team that approaches discharges as a QI project, Dr. Gupta explains. "Building that team is huge," he says. "It adds a whole new perspective." At UCSF, the team meets monthly and includes hospitalists, PCPs, staff nurses and nursing supervisors, pharmacists, care managers, and patients.

For more information about Project BOOST, visit SHM's resource room.

Every six months, physicians and nurses from Geisinger Medical Center in Danville, Pa., travel to a rural area outside of Chiquimula, Guatemala, to care for people who live without access to modern medicine. Lice, tooth decay, poor eyesight, and asthma are common. Some of the locals suffer from more severe health issues, including parasitic infections, pneumonia, malnutrition, and malaria.

Joel L. Strohecker, DO, a family-medicine-trained hospitalist practicing at Lutheran Medical Center and St. Anthony Hospital in Denver, joined the Geisinger group in June. He recently spoke with TH eWire about his weeklong trip.

Question: About 70% of your patients were children. When did you really feel like you were able to help?

Answer: A couple of little kids who had asthma were brought back a couple days later and were so much better. And the joint injections you could do for the men who worked in the fields. Those were gratifying experiences because they immediately feel better. Then they bring their families the next day because we’ve done something good for them.

Q: You mentioned one memorable patient, a woman with a spinal cord injury. Tell me more about her.

A: She's someone that brought tears to my eyes. It had taken her a couple of hours to walk the trails to get there. She had fallen 20 years earlier and had never been able to really walk well since then. It was very obvious, just by her exam, that she had an upper cervical spinal cord injury. It was just so sad. I mean, what can you do? We gave her steroids, but she had diminished function in her legs.

Q: What was the most rewarding part of the trip?

A: The work was tiring and not necessarily uplifting at times, but I think the best part for me was when we would go back to Chiquimula every night. … We would all go back and play soccer. For me, that was probably the biggest treat and most enjoyable time of the trip. You weren't just a tourist; you were really embedded with the people.

For more information about volunteer opportunities in Guatemala, contact Dr. Strohecker at [email protected].

Every six months, physicians and nurses from Geisinger Medical Center in Danville, Pa., travel to a rural area outside of Chiquimula, Guatemala, to care for people who live without access to modern medicine. Lice, tooth decay, poor eyesight, and asthma are common. Some of the locals suffer from more severe health issues, including parasitic infections, pneumonia, malnutrition, and malaria.

Joel L. Strohecker, DO, a family-medicine-trained hospitalist practicing at Lutheran Medical Center and St. Anthony Hospital in Denver, joined the Geisinger group in June. He recently spoke with TH eWire about his weeklong trip.

Question: About 70% of your patients were children. When did you really feel like you were able to help?

Answer: A couple of little kids who had asthma were brought back a couple days later and were so much better. And the joint injections you could do for the men who worked in the fields. Those were gratifying experiences because they immediately feel better. Then they bring their families the next day because we’ve done something good for them.

Q: You mentioned one memorable patient, a woman with a spinal cord injury. Tell me more about her.

A: She's someone that brought tears to my eyes. It had taken her a couple of hours to walk the trails to get there. She had fallen 20 years earlier and had never been able to really walk well since then. It was very obvious, just by her exam, that she had an upper cervical spinal cord injury. It was just so sad. I mean, what can you do? We gave her steroids, but she had diminished function in her legs.

Q: What was the most rewarding part of the trip?

A: The work was tiring and not necessarily uplifting at times, but I think the best part for me was when we would go back to Chiquimula every night. … We would all go back and play soccer. For me, that was probably the biggest treat and most enjoyable time of the trip. You weren't just a tourist; you were really embedded with the people.

For more information about volunteer opportunities in Guatemala, contact Dr. Strohecker at [email protected].

Every six months, physicians and nurses from Geisinger Medical Center in Danville, Pa., travel to a rural area outside of Chiquimula, Guatemala, to care for people who live without access to modern medicine. Lice, tooth decay, poor eyesight, and asthma are common. Some of the locals suffer from more severe health issues, including parasitic infections, pneumonia, malnutrition, and malaria.

Joel L. Strohecker, DO, a family-medicine-trained hospitalist practicing at Lutheran Medical Center and St. Anthony Hospital in Denver, joined the Geisinger group in June. He recently spoke with TH eWire about his weeklong trip.

Question: About 70% of your patients were children. When did you really feel like you were able to help?

Answer: A couple of little kids who had asthma were brought back a couple days later and were so much better. And the joint injections you could do for the men who worked in the fields. Those were gratifying experiences because they immediately feel better. Then they bring their families the next day because we’ve done something good for them.

Q: You mentioned one memorable patient, a woman with a spinal cord injury. Tell me more about her.

A: She's someone that brought tears to my eyes. It had taken her a couple of hours to walk the trails to get there. She had fallen 20 years earlier and had never been able to really walk well since then. It was very obvious, just by her exam, that she had an upper cervical spinal cord injury. It was just so sad. I mean, what can you do? We gave her steroids, but she had diminished function in her legs.

Q: What was the most rewarding part of the trip?

A: The work was tiring and not necessarily uplifting at times, but I think the best part for me was when we would go back to Chiquimula every night. … We would all go back and play soccer. For me, that was probably the biggest treat and most enjoyable time of the trip. You weren't just a tourist; you were really embedded with the people.

For more information about volunteer opportunities in Guatemala, contact Dr. Strohecker at [email protected].

The final 2010 Medicare physician fee schedule presents a mixed bag for hospitalists. As officials from the Centers for Medicare and Medicaid Services (CMS) warned, the update carries a hefty 21.2% fee schedule cut. Congressional action to avert that cut is expected, though wrangling over healthcare reform may force a stopgap measure to prevent the cuts from taking effect Jan. 1.

In a statement, Jonathan Blum, director of the CMS Center for Medicare Management, said the Obama administration is committed to repealing the sustainable growth rate formula that resulted in the substantial cut. In the meantime, he said, CMS is finalizing its proposal to drop physician-administered drugs from the definition of "physician services," which is used to formulate future fee updates. SHM has strongly supported both efforts and is calling on members to contact their legislators before a Nov. 16 vote.

Another huge change for hospitalists: The use of consultation codes has been discontinued, with the exception of codes related to telemedicine. In their place, healthcare providers must bill under initial hospital care, initial nursing facility care, or initial office visits. All transfers of care, for example, will now require billing under an initial visit code rather than a subsequent visit code. Consultation documentation requirements will no longer apply, though initial codes could be valued somewhat lower than similar consultation codes despite proposed adjustments to the relative value units (RVUs). Although bad for traditional consultations, some analysts see the net change as good for the comanagement of patients.

To help smooth the transition to this new coding system, SHM will be hosting a webinar, "Hot Topics in Evaluation and Management Coding," on Dec. 2.

The final 2010 Medicare physician fee schedule presents a mixed bag for hospitalists. As officials from the Centers for Medicare and Medicaid Services (CMS) warned, the update carries a hefty 21.2% fee schedule cut. Congressional action to avert that cut is expected, though wrangling over healthcare reform may force a stopgap measure to prevent the cuts from taking effect Jan. 1.

In a statement, Jonathan Blum, director of the CMS Center for Medicare Management, said the Obama administration is committed to repealing the sustainable growth rate formula that resulted in the substantial cut. In the meantime, he said, CMS is finalizing its proposal to drop physician-administered drugs from the definition of "physician services," which is used to formulate future fee updates. SHM has strongly supported both efforts and is calling on members to contact their legislators before a Nov. 16 vote.

Another huge change for hospitalists: The use of consultation codes has been discontinued, with the exception of codes related to telemedicine. In their place, healthcare providers must bill under initial hospital care, initial nursing facility care, or initial office visits. All transfers of care, for example, will now require billing under an initial visit code rather than a subsequent visit code. Consultation documentation requirements will no longer apply, though initial codes could be valued somewhat lower than similar consultation codes despite proposed adjustments to the relative value units (RVUs). Although bad for traditional consultations, some analysts see the net change as good for the comanagement of patients.

To help smooth the transition to this new coding system, SHM will be hosting a webinar, "Hot Topics in Evaluation and Management Coding," on Dec. 2.

The final 2010 Medicare physician fee schedule presents a mixed bag for hospitalists. As officials from the Centers for Medicare and Medicaid Services (CMS) warned, the update carries a hefty 21.2% fee schedule cut. Congressional action to avert that cut is expected, though wrangling over healthcare reform may force a stopgap measure to prevent the cuts from taking effect Jan. 1.

In a statement, Jonathan Blum, director of the CMS Center for Medicare Management, said the Obama administration is committed to repealing the sustainable growth rate formula that resulted in the substantial cut. In the meantime, he said, CMS is finalizing its proposal to drop physician-administered drugs from the definition of "physician services," which is used to formulate future fee updates. SHM has strongly supported both efforts and is calling on members to contact their legislators before a Nov. 16 vote.

Another huge change for hospitalists: The use of consultation codes has been discontinued, with the exception of codes related to telemedicine. In their place, healthcare providers must bill under initial hospital care, initial nursing facility care, or initial office visits. All transfers of care, for example, will now require billing under an initial visit code rather than a subsequent visit code. Consultation documentation requirements will no longer apply, though initial codes could be valued somewhat lower than similar consultation codes despite proposed adjustments to the relative value units (RVUs). Although bad for traditional consultations, some analysts see the net change as good for the comanagement of patients.

To help smooth the transition to this new coding system, SHM will be hosting a webinar, "Hot Topics in Evaluation and Management Coding," on Dec. 2.