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Boundary crossings: Guard against inappropriate contact
Woman claims improper contact during treatment
Fairfax County (VA) Circuit Court
A 23-year-old woman who received treatment from a psychiatrist for approximately 2½ years claimed that he sexually abused her during that time. She alleged that the inappropriate sexual relationship included holding, hugging, kissing, fondling, and watching pornography. The patient claimed that the relationship led to emotional distress and caused her to attempt suicide.
The psychiatrist admitted that a sexual relationship occurred but contended that the patient suffered no harm.
A $400,000 verdict was returned
Did inappropriate contact cause agoraphobia, anorexia?
Suffolk County (MA) Superior Court
A patient in her 20s had a history of emotional problems and sexual assaults against her. A psychiatrist treated her for obsessive-compulsive disorder for 4 years. He acknowledged giving the patient stuffed animals, cards, and letters and visiting her home several times when she was unable to go to his office. During sessions he touched her hand for comfort and hugged her. The patient claimed they had regular sexual contact.
The patient alleged that the psychiatrist was negligent for engaging in inappropriate sexual conduct, which she claims caused ongoing emotional distress. She claimed she was unable to work and suffered from agoraphobia, intimate relationships difficulties, and anorexia as a result of his actions. The psychiatrist denied any inappropriate sexual conduct.
The psychiatrist’s license was suspended indefinitely, but the suspension was stayed under an agreement that he attend medical education courses.
A $750,000 settlement was reached
Dr. Grant’s observations
Although most physicians would agree that sexual relations with a patient are inappropriate,1 the fact that cases continue to occur suggests a need to emphasize treatment boundaries. Establishing clear boundaries in the doctor-patient relationship creates an atmosphere of safety and predictability that allows treatment to thrive.2
Boundary problems are one of the most frequent reasons for malpractice actions against mental health providers.3 Although much of the literature discusses boundary violations during psychotherapy, issues may arise in all treatment settings, including psychopharmacologic management.
One-half of all psychiatrists will treat at least 1 victim of physician sexual misconduct during their careers.4 One study5 examining sex-related offenses committed by U.S. physicians in all specialties found:
- The number of physicians disciplined for sex-related offenses increased each year from 1989 to 1996.
- 22% of disciplined physicians had sexual intercourse with patients, 15% had sexual contact or touching, 37% committed other sexual abuse that did not fit in either of these 2 categories, and 25% involved nonpatients.
- 28% of disciplined physicians were psychiatrists, the most represented specialty in the study.
The American Medical Association’s Principles of Medical Ethics with Annotations Especially Applicable to Psychiatry states: A psychiatrist shall not gratify his or her own needs by exploiting the patient. The psychiatrist shall be ever vigilant about the impact that his or her conduct has upon the boundaries of the doctor-patient relationship, and thus upon the well-being of the patient. These requirements become particularly important because of the essentially private, highly personal, and sometimes intensely emotional nature of the relationship established with the psychiatrist.
“Further, the necessary intensity of the treatment relationship may tend to activate sexual and other needs and fantasies on the part of both patient and psychiatrist, while weakening the objectivity necessary for control. Additionally the inherent inequality in the doctor-patient relationship may lead to exploitation of the patient. Sexual activity with a current or former patient is unethical.”
Source: Reference 9
In a 1986 survey of psychiatrists, 7% of male and 3% of female clinicians reported having sexual contact with their patients.6 A 1988 survey of fourth-year psychiatry residents found that 1% of respondents acknowledged having sexual relations with a patient.7 In a 1992 study, 9% of physicians across specialties reported engaging in sexual contact with 1 or more current or former patients.8 In that study, 19% of female physicians and 40% of male physicians reported that they did not think physician-patient sexual misconduct was always harmful to patients.8 These views and behaviors are in violation of medical codes of ethics (Box).9
How misconduct harms patients
Trust is essential to establishing a secure therapeutic relationship. Boundary violations may result in missed diagnoses, inappropriate treatment, and/or worsened psychiatric symptoms. Patients might develop complex posttraumatic stress disorder, depression, anxiety, dissociation, sexual dysfunction, somatoform disorders, eating disorders, sleep disorders, or substance use disorders.4 They could lose faith in their treatment providers, have difficulties expressing anger, feel guilty, develop poor self-concept, experience a loss of confidence, and develop problems establishing trusting relationships.4 For these reasons, clinicians can be sued for negligent treatment and sexual misconduct.10
Boundary violations
Although sexual activities with patients are clear boundary violations, what about the second case when the therapist gave the patient stuffed animals and cards and hugged her? Progressive boundary violations often precede and accompany sexual misconduct.10
Five risk factors have been associated with therapist boundary violations:3
- life crises—effects of aging, career disappointments, unfulfilled hopes, or marital conflicts
- transitions—job changes or job loss
- medical illness
- arrogance—the belief that a boundary violation couldn’t happen to him or her and not recognizing the need for consultation
- common stress points with the patient
Although the list is not exhaustive, these factors may be associated with a psychiatrist turning to the patient for solace, gratification, or excitement.
Drawing boundary lines
Not all boundary issues are the same, and Gutheil et al2 suggest 2 categories:
- Boundary crossings—a benign variant where the deviation may advance therapy in a constructive way that does not harm the patient, such as discussion of countertransference.
- Boundary violations—the transgression harms or exploits the patient.
Although some boundary issues may appear benign, even theoretically harmless boundary crossings can be misrepresented or misconstrued by the patient.11 Also, boundary transgressions that do not involve erotic touch might harm the treatment process and the patient.2
When examining “minor” boundary issues that may seem innocuous, ask yourself if the action is for your benefit rather than to advance the patient’s therapy. Also, determine if the intervention is part of a series of progressive boundary violations. If the answer to either question is “yes,” desist immediately and take corrective action.10
The psychiatrist has a professional code of ethics to follow and can be held responsible for failing to set or adhere to boundaries.11 If a patient initiates a boundary violation, you must refuse and then explore the patient’s underlying psychological issues, perhaps aided by consultation with a peer or mentor (Table). Repeated patient demands to breach boundaries requires prompt consultation to determine if you can continue treating the patient or if you should transfer the patient to another clinician. Document the patient’s demands to breach boundaries and your actions when seeking consultation.3
Table 1
How to maintain integrity of the treatment process
Maintain relative therapist neutrality |
Foster psychological separateness of the patient |
Protect confidentiality |
Obtain informed consent for treatments and procedures |
Interact verbally with patients |
Ensure that you do not have any previous, current, or future personal relationships with the patient |
Minimize physical contact |
Preserve the therapist’s relative anonymity |
Establish a stable fee policy |
Provide a consistent, private, and professional setting |
Define the time and length of sessions |
Source: Reference 10 |
1. Herman J, Gartrell N, Olarte S, et al. Psychiatrist-patient sexual contact: results of a national survey, II: psychiatrists’ attitudes. Am J Psychiatry 1987;144:164-9.
2. Gutheil TG, Gabbard GO. Misuses and misunderstandings of boundary theory in clinical and regulatory settings. Am J Psychiatry 1998;155:409-14.
3. Norris DM, Gutheil TG, Strasburger LH. This couldn’t happen to me: boundary problems and sexual misconduct in the psychotherapy relationship. Psychiatr Serv 2003;54:517-22.
4. Roman B, Kay J. Residency education on the prevention of physician-patient sexual misconduct. Acad Psychiatry 1997;21:26-34.
5. Dehlendorf CE, Wolfe SM. Physicians disciplined for sexrelated offenses. JAMA 1998;279:1883-8.
6. Gartrell NK, Herman J, Olarte S, et al. Psychiatrist-patient sexual contact: results of a national survey, 1: prevalence. Am J Psychiatry 1986;143:1126-31.
7. Gartrell NK, Herman J, Olarte S, et al. Psychiatric residents’ sexual contact with educators and patients: results of a national survey. Am J Psychiatry 1988;145:690-4.
8. Gartrell NK, Milliken M, Goodsen WH, et al. Physicianpatient sexual contact. West J Med 1992;157:139-43.
9. The principles of medical ethics with annotations especially applicable to psychiatry. Washington, DC: American Psychiatric Association. Available at: http://www.psych.org/psych_pract/ethics/ppaethics.pdf. Accessed August 28, 2007.
10. Simon RI. Boundary violations in psychotherapy. In: Lifson LE, Simon RI, eds. The mental health practitioner and the law. Cambridge, MA: Harvard University Press; 1998:195-215.
11. Gutheil TG. Boundaries, blackmail, and double binds: a pattern observed in malpractice consultation. J Am Acad Psychiatry Law 2005;33:476-81.
Cases are selected by Current Psychiatry from Medical Malpractice Verdicts, Settlements & Experts, with permission of its editor, Lewis Laska of Nashville, TN (www.verdictslaska.com). Information may be incomplete in some instances, but these cases represent clinical situations that typically result in litigation.
Woman claims improper contact during treatment
Fairfax County (VA) Circuit Court
A 23-year-old woman who received treatment from a psychiatrist for approximately 2½ years claimed that he sexually abused her during that time. She alleged that the inappropriate sexual relationship included holding, hugging, kissing, fondling, and watching pornography. The patient claimed that the relationship led to emotional distress and caused her to attempt suicide.
The psychiatrist admitted that a sexual relationship occurred but contended that the patient suffered no harm.
A $400,000 verdict was returned
Did inappropriate contact cause agoraphobia, anorexia?
Suffolk County (MA) Superior Court
A patient in her 20s had a history of emotional problems and sexual assaults against her. A psychiatrist treated her for obsessive-compulsive disorder for 4 years. He acknowledged giving the patient stuffed animals, cards, and letters and visiting her home several times when she was unable to go to his office. During sessions he touched her hand for comfort and hugged her. The patient claimed they had regular sexual contact.
The patient alleged that the psychiatrist was negligent for engaging in inappropriate sexual conduct, which she claims caused ongoing emotional distress. She claimed she was unable to work and suffered from agoraphobia, intimate relationships difficulties, and anorexia as a result of his actions. The psychiatrist denied any inappropriate sexual conduct.
The psychiatrist’s license was suspended indefinitely, but the suspension was stayed under an agreement that he attend medical education courses.
A $750,000 settlement was reached
Dr. Grant’s observations
Although most physicians would agree that sexual relations with a patient are inappropriate,1 the fact that cases continue to occur suggests a need to emphasize treatment boundaries. Establishing clear boundaries in the doctor-patient relationship creates an atmosphere of safety and predictability that allows treatment to thrive.2
Boundary problems are one of the most frequent reasons for malpractice actions against mental health providers.3 Although much of the literature discusses boundary violations during psychotherapy, issues may arise in all treatment settings, including psychopharmacologic management.
One-half of all psychiatrists will treat at least 1 victim of physician sexual misconduct during their careers.4 One study5 examining sex-related offenses committed by U.S. physicians in all specialties found:
- The number of physicians disciplined for sex-related offenses increased each year from 1989 to 1996.
- 22% of disciplined physicians had sexual intercourse with patients, 15% had sexual contact or touching, 37% committed other sexual abuse that did not fit in either of these 2 categories, and 25% involved nonpatients.
- 28% of disciplined physicians were psychiatrists, the most represented specialty in the study.
The American Medical Association’s Principles of Medical Ethics with Annotations Especially Applicable to Psychiatry states: A psychiatrist shall not gratify his or her own needs by exploiting the patient. The psychiatrist shall be ever vigilant about the impact that his or her conduct has upon the boundaries of the doctor-patient relationship, and thus upon the well-being of the patient. These requirements become particularly important because of the essentially private, highly personal, and sometimes intensely emotional nature of the relationship established with the psychiatrist.
“Further, the necessary intensity of the treatment relationship may tend to activate sexual and other needs and fantasies on the part of both patient and psychiatrist, while weakening the objectivity necessary for control. Additionally the inherent inequality in the doctor-patient relationship may lead to exploitation of the patient. Sexual activity with a current or former patient is unethical.”
Source: Reference 9
In a 1986 survey of psychiatrists, 7% of male and 3% of female clinicians reported having sexual contact with their patients.6 A 1988 survey of fourth-year psychiatry residents found that 1% of respondents acknowledged having sexual relations with a patient.7 In a 1992 study, 9% of physicians across specialties reported engaging in sexual contact with 1 or more current or former patients.8 In that study, 19% of female physicians and 40% of male physicians reported that they did not think physician-patient sexual misconduct was always harmful to patients.8 These views and behaviors are in violation of medical codes of ethics (Box).9
How misconduct harms patients
Trust is essential to establishing a secure therapeutic relationship. Boundary violations may result in missed diagnoses, inappropriate treatment, and/or worsened psychiatric symptoms. Patients might develop complex posttraumatic stress disorder, depression, anxiety, dissociation, sexual dysfunction, somatoform disorders, eating disorders, sleep disorders, or substance use disorders.4 They could lose faith in their treatment providers, have difficulties expressing anger, feel guilty, develop poor self-concept, experience a loss of confidence, and develop problems establishing trusting relationships.4 For these reasons, clinicians can be sued for negligent treatment and sexual misconduct.10
Boundary violations
Although sexual activities with patients are clear boundary violations, what about the second case when the therapist gave the patient stuffed animals and cards and hugged her? Progressive boundary violations often precede and accompany sexual misconduct.10
Five risk factors have been associated with therapist boundary violations:3
- life crises—effects of aging, career disappointments, unfulfilled hopes, or marital conflicts
- transitions—job changes or job loss
- medical illness
- arrogance—the belief that a boundary violation couldn’t happen to him or her and not recognizing the need for consultation
- common stress points with the patient
Although the list is not exhaustive, these factors may be associated with a psychiatrist turning to the patient for solace, gratification, or excitement.
Drawing boundary lines
Not all boundary issues are the same, and Gutheil et al2 suggest 2 categories:
- Boundary crossings—a benign variant where the deviation may advance therapy in a constructive way that does not harm the patient, such as discussion of countertransference.
- Boundary violations—the transgression harms or exploits the patient.
Although some boundary issues may appear benign, even theoretically harmless boundary crossings can be misrepresented or misconstrued by the patient.11 Also, boundary transgressions that do not involve erotic touch might harm the treatment process and the patient.2
When examining “minor” boundary issues that may seem innocuous, ask yourself if the action is for your benefit rather than to advance the patient’s therapy. Also, determine if the intervention is part of a series of progressive boundary violations. If the answer to either question is “yes,” desist immediately and take corrective action.10
The psychiatrist has a professional code of ethics to follow and can be held responsible for failing to set or adhere to boundaries.11 If a patient initiates a boundary violation, you must refuse and then explore the patient’s underlying psychological issues, perhaps aided by consultation with a peer or mentor (Table). Repeated patient demands to breach boundaries requires prompt consultation to determine if you can continue treating the patient or if you should transfer the patient to another clinician. Document the patient’s demands to breach boundaries and your actions when seeking consultation.3
Table 1
How to maintain integrity of the treatment process
Maintain relative therapist neutrality |
Foster psychological separateness of the patient |
Protect confidentiality |
Obtain informed consent for treatments and procedures |
Interact verbally with patients |
Ensure that you do not have any previous, current, or future personal relationships with the patient |
Minimize physical contact |
Preserve the therapist’s relative anonymity |
Establish a stable fee policy |
Provide a consistent, private, and professional setting |
Define the time and length of sessions |
Source: Reference 10 |
Woman claims improper contact during treatment
Fairfax County (VA) Circuit Court
A 23-year-old woman who received treatment from a psychiatrist for approximately 2½ years claimed that he sexually abused her during that time. She alleged that the inappropriate sexual relationship included holding, hugging, kissing, fondling, and watching pornography. The patient claimed that the relationship led to emotional distress and caused her to attempt suicide.
The psychiatrist admitted that a sexual relationship occurred but contended that the patient suffered no harm.
A $400,000 verdict was returned
Did inappropriate contact cause agoraphobia, anorexia?
Suffolk County (MA) Superior Court
A patient in her 20s had a history of emotional problems and sexual assaults against her. A psychiatrist treated her for obsessive-compulsive disorder for 4 years. He acknowledged giving the patient stuffed animals, cards, and letters and visiting her home several times when she was unable to go to his office. During sessions he touched her hand for comfort and hugged her. The patient claimed they had regular sexual contact.
The patient alleged that the psychiatrist was negligent for engaging in inappropriate sexual conduct, which she claims caused ongoing emotional distress. She claimed she was unable to work and suffered from agoraphobia, intimate relationships difficulties, and anorexia as a result of his actions. The psychiatrist denied any inappropriate sexual conduct.
The psychiatrist’s license was suspended indefinitely, but the suspension was stayed under an agreement that he attend medical education courses.
A $750,000 settlement was reached
Dr. Grant’s observations
Although most physicians would agree that sexual relations with a patient are inappropriate,1 the fact that cases continue to occur suggests a need to emphasize treatment boundaries. Establishing clear boundaries in the doctor-patient relationship creates an atmosphere of safety and predictability that allows treatment to thrive.2
Boundary problems are one of the most frequent reasons for malpractice actions against mental health providers.3 Although much of the literature discusses boundary violations during psychotherapy, issues may arise in all treatment settings, including psychopharmacologic management.
One-half of all psychiatrists will treat at least 1 victim of physician sexual misconduct during their careers.4 One study5 examining sex-related offenses committed by U.S. physicians in all specialties found:
- The number of physicians disciplined for sex-related offenses increased each year from 1989 to 1996.
- 22% of disciplined physicians had sexual intercourse with patients, 15% had sexual contact or touching, 37% committed other sexual abuse that did not fit in either of these 2 categories, and 25% involved nonpatients.
- 28% of disciplined physicians were psychiatrists, the most represented specialty in the study.
The American Medical Association’s Principles of Medical Ethics with Annotations Especially Applicable to Psychiatry states: A psychiatrist shall not gratify his or her own needs by exploiting the patient. The psychiatrist shall be ever vigilant about the impact that his or her conduct has upon the boundaries of the doctor-patient relationship, and thus upon the well-being of the patient. These requirements become particularly important because of the essentially private, highly personal, and sometimes intensely emotional nature of the relationship established with the psychiatrist.
“Further, the necessary intensity of the treatment relationship may tend to activate sexual and other needs and fantasies on the part of both patient and psychiatrist, while weakening the objectivity necessary for control. Additionally the inherent inequality in the doctor-patient relationship may lead to exploitation of the patient. Sexual activity with a current or former patient is unethical.”
Source: Reference 9
In a 1986 survey of psychiatrists, 7% of male and 3% of female clinicians reported having sexual contact with their patients.6 A 1988 survey of fourth-year psychiatry residents found that 1% of respondents acknowledged having sexual relations with a patient.7 In a 1992 study, 9% of physicians across specialties reported engaging in sexual contact with 1 or more current or former patients.8 In that study, 19% of female physicians and 40% of male physicians reported that they did not think physician-patient sexual misconduct was always harmful to patients.8 These views and behaviors are in violation of medical codes of ethics (Box).9
How misconduct harms patients
Trust is essential to establishing a secure therapeutic relationship. Boundary violations may result in missed diagnoses, inappropriate treatment, and/or worsened psychiatric symptoms. Patients might develop complex posttraumatic stress disorder, depression, anxiety, dissociation, sexual dysfunction, somatoform disorders, eating disorders, sleep disorders, or substance use disorders.4 They could lose faith in their treatment providers, have difficulties expressing anger, feel guilty, develop poor self-concept, experience a loss of confidence, and develop problems establishing trusting relationships.4 For these reasons, clinicians can be sued for negligent treatment and sexual misconduct.10
Boundary violations
Although sexual activities with patients are clear boundary violations, what about the second case when the therapist gave the patient stuffed animals and cards and hugged her? Progressive boundary violations often precede and accompany sexual misconduct.10
Five risk factors have been associated with therapist boundary violations:3
- life crises—effects of aging, career disappointments, unfulfilled hopes, or marital conflicts
- transitions—job changes or job loss
- medical illness
- arrogance—the belief that a boundary violation couldn’t happen to him or her and not recognizing the need for consultation
- common stress points with the patient
Although the list is not exhaustive, these factors may be associated with a psychiatrist turning to the patient for solace, gratification, or excitement.
Drawing boundary lines
Not all boundary issues are the same, and Gutheil et al2 suggest 2 categories:
- Boundary crossings—a benign variant where the deviation may advance therapy in a constructive way that does not harm the patient, such as discussion of countertransference.
- Boundary violations—the transgression harms or exploits the patient.
Although some boundary issues may appear benign, even theoretically harmless boundary crossings can be misrepresented or misconstrued by the patient.11 Also, boundary transgressions that do not involve erotic touch might harm the treatment process and the patient.2
When examining “minor” boundary issues that may seem innocuous, ask yourself if the action is for your benefit rather than to advance the patient’s therapy. Also, determine if the intervention is part of a series of progressive boundary violations. If the answer to either question is “yes,” desist immediately and take corrective action.10
The psychiatrist has a professional code of ethics to follow and can be held responsible for failing to set or adhere to boundaries.11 If a patient initiates a boundary violation, you must refuse and then explore the patient’s underlying psychological issues, perhaps aided by consultation with a peer or mentor (Table). Repeated patient demands to breach boundaries requires prompt consultation to determine if you can continue treating the patient or if you should transfer the patient to another clinician. Document the patient’s demands to breach boundaries and your actions when seeking consultation.3
Table 1
How to maintain integrity of the treatment process
Maintain relative therapist neutrality |
Foster psychological separateness of the patient |
Protect confidentiality |
Obtain informed consent for treatments and procedures |
Interact verbally with patients |
Ensure that you do not have any previous, current, or future personal relationships with the patient |
Minimize physical contact |
Preserve the therapist’s relative anonymity |
Establish a stable fee policy |
Provide a consistent, private, and professional setting |
Define the time and length of sessions |
Source: Reference 10 |
1. Herman J, Gartrell N, Olarte S, et al. Psychiatrist-patient sexual contact: results of a national survey, II: psychiatrists’ attitudes. Am J Psychiatry 1987;144:164-9.
2. Gutheil TG, Gabbard GO. Misuses and misunderstandings of boundary theory in clinical and regulatory settings. Am J Psychiatry 1998;155:409-14.
3. Norris DM, Gutheil TG, Strasburger LH. This couldn’t happen to me: boundary problems and sexual misconduct in the psychotherapy relationship. Psychiatr Serv 2003;54:517-22.
4. Roman B, Kay J. Residency education on the prevention of physician-patient sexual misconduct. Acad Psychiatry 1997;21:26-34.
5. Dehlendorf CE, Wolfe SM. Physicians disciplined for sexrelated offenses. JAMA 1998;279:1883-8.
6. Gartrell NK, Herman J, Olarte S, et al. Psychiatrist-patient sexual contact: results of a national survey, 1: prevalence. Am J Psychiatry 1986;143:1126-31.
7. Gartrell NK, Herman J, Olarte S, et al. Psychiatric residents’ sexual contact with educators and patients: results of a national survey. Am J Psychiatry 1988;145:690-4.
8. Gartrell NK, Milliken M, Goodsen WH, et al. Physicianpatient sexual contact. West J Med 1992;157:139-43.
9. The principles of medical ethics with annotations especially applicable to psychiatry. Washington, DC: American Psychiatric Association. Available at: http://www.psych.org/psych_pract/ethics/ppaethics.pdf. Accessed August 28, 2007.
10. Simon RI. Boundary violations in psychotherapy. In: Lifson LE, Simon RI, eds. The mental health practitioner and the law. Cambridge, MA: Harvard University Press; 1998:195-215.
11. Gutheil TG. Boundaries, blackmail, and double binds: a pattern observed in malpractice consultation. J Am Acad Psychiatry Law 2005;33:476-81.
Cases are selected by Current Psychiatry from Medical Malpractice Verdicts, Settlements & Experts, with permission of its editor, Lewis Laska of Nashville, TN (www.verdictslaska.com). Information may be incomplete in some instances, but these cases represent clinical situations that typically result in litigation.
1. Herman J, Gartrell N, Olarte S, et al. Psychiatrist-patient sexual contact: results of a national survey, II: psychiatrists’ attitudes. Am J Psychiatry 1987;144:164-9.
2. Gutheil TG, Gabbard GO. Misuses and misunderstandings of boundary theory in clinical and regulatory settings. Am J Psychiatry 1998;155:409-14.
3. Norris DM, Gutheil TG, Strasburger LH. This couldn’t happen to me: boundary problems and sexual misconduct in the psychotherapy relationship. Psychiatr Serv 2003;54:517-22.
4. Roman B, Kay J. Residency education on the prevention of physician-patient sexual misconduct. Acad Psychiatry 1997;21:26-34.
5. Dehlendorf CE, Wolfe SM. Physicians disciplined for sexrelated offenses. JAMA 1998;279:1883-8.
6. Gartrell NK, Herman J, Olarte S, et al. Psychiatrist-patient sexual contact: results of a national survey, 1: prevalence. Am J Psychiatry 1986;143:1126-31.
7. Gartrell NK, Herman J, Olarte S, et al. Psychiatric residents’ sexual contact with educators and patients: results of a national survey. Am J Psychiatry 1988;145:690-4.
8. Gartrell NK, Milliken M, Goodsen WH, et al. Physicianpatient sexual contact. West J Med 1992;157:139-43.
9. The principles of medical ethics with annotations especially applicable to psychiatry. Washington, DC: American Psychiatric Association. Available at: http://www.psych.org/psych_pract/ethics/ppaethics.pdf. Accessed August 28, 2007.
10. Simon RI. Boundary violations in psychotherapy. In: Lifson LE, Simon RI, eds. The mental health practitioner and the law. Cambridge, MA: Harvard University Press; 1998:195-215.
11. Gutheil TG. Boundaries, blackmail, and double binds: a pattern observed in malpractice consultation. J Am Acad Psychiatry Law 2005;33:476-81.
Cases are selected by Current Psychiatry from Medical Malpractice Verdicts, Settlements & Experts, with permission of its editor, Lewis Laska of Nashville, TN (www.verdictslaska.com). Information may be incomplete in some instances, but these cases represent clinical situations that typically result in litigation.
REIMBURSEMENT ADVISER
If the US scan is also inconclusive, you can report 793.91 (image test inconclusive due to excess body fat) with another code that represents the patient’s documented body mass index.
Appeal the determination if the US scan is denied on the basis of medical necessity. Let the payer know that a thorough pelvic exam could not be completed because of the patient’s body mass; point out that obesity is a risk factor for cancer.
Making those points should help you get paid, eventually—although The Centers for Medicare & Medicaid Services (CMS) and most payers have determined that US as a confirmatory adjunct to physical examination (in the absence of an abnormal finding) will not be reimbursed.
The first question in this Reimbursement Adviser addresses a dilemma in the office-based care of obese women. For a comprehensive review of risks and remedies when an obese patient faces surgery, see "Risks and remedies when your surgical patient is obese"
Slow payment for unlisted codes for lap hysterectomy
(There is good news here: New codes for total laparoscopic hysterectomy will be available beginning January 1, 2008. Look for details on these and other changes in Reimbursement Adviser in the December 2007 issue of OBG Management.)
Of course, your other coding option is to report the unlisted code 58578 (un-listed laparoscopic procedure, uterus). If you choose that option, however, you will have to submit the operative report with the claim, along with a letter from the physician explaining why this procedure was more advantageous to the patient than LAVH. And although using an unlisted code will not mean denial of service, it will slow down payment.
No need for modifiers on self-performed US scans
Although you are acting as your own sonographer for your scans, this still represents the technical component of a scan, which is reimbursed when reporting the unmodified code for the service.
It’s “false labor” if there’s no bleeding—at any date
Colporrhaphy? Do not code for posterior repair
The code 45560, on the other hand, is listed in the digestive section of CPT and is, basically, a transanal approach procedure that has a vaginal component. It is much different than posterior colporrhaphy, and is typically performed when a patient with a rectocele has fecal incontinence.
Although 45560 does carry slightly more RVUs than 57250 (posterior colporrhaphy, repair of rectocele with or without perineorrhaphy), the physician work portion of the RVU total for both codes is now identical: 11.42.
Last, be aware: Payers consider it fraud for a surgeon to use the wrong code in this situation because it pays more, when, in fact, colporrhaphy has been performed and documented.
Patient asks for test; is that “medical necessity”?
If the US scan is also inconclusive, you can report 793.91 (image test inconclusive due to excess body fat) with another code that represents the patient’s documented body mass index.
Appeal the determination if the US scan is denied on the basis of medical necessity. Let the payer know that a thorough pelvic exam could not be completed because of the patient’s body mass; point out that obesity is a risk factor for cancer.
Making those points should help you get paid, eventually—although The Centers for Medicare & Medicaid Services (CMS) and most payers have determined that US as a confirmatory adjunct to physical examination (in the absence of an abnormal finding) will not be reimbursed.
The first question in this Reimbursement Adviser addresses a dilemma in the office-based care of obese women. For a comprehensive review of risks and remedies when an obese patient faces surgery, see "Risks and remedies when your surgical patient is obese"
Slow payment for unlisted codes for lap hysterectomy
(There is good news here: New codes for total laparoscopic hysterectomy will be available beginning January 1, 2008. Look for details on these and other changes in Reimbursement Adviser in the December 2007 issue of OBG Management.)
Of course, your other coding option is to report the unlisted code 58578 (un-listed laparoscopic procedure, uterus). If you choose that option, however, you will have to submit the operative report with the claim, along with a letter from the physician explaining why this procedure was more advantageous to the patient than LAVH. And although using an unlisted code will not mean denial of service, it will slow down payment.
No need for modifiers on self-performed US scans
Although you are acting as your own sonographer for your scans, this still represents the technical component of a scan, which is reimbursed when reporting the unmodified code for the service.
It’s “false labor” if there’s no bleeding—at any date
Colporrhaphy? Do not code for posterior repair
The code 45560, on the other hand, is listed in the digestive section of CPT and is, basically, a transanal approach procedure that has a vaginal component. It is much different than posterior colporrhaphy, and is typically performed when a patient with a rectocele has fecal incontinence.
Although 45560 does carry slightly more RVUs than 57250 (posterior colporrhaphy, repair of rectocele with or without perineorrhaphy), the physician work portion of the RVU total for both codes is now identical: 11.42.
Last, be aware: Payers consider it fraud for a surgeon to use the wrong code in this situation because it pays more, when, in fact, colporrhaphy has been performed and documented.
Patient asks for test; is that “medical necessity”?
If the US scan is also inconclusive, you can report 793.91 (image test inconclusive due to excess body fat) with another code that represents the patient’s documented body mass index.
Appeal the determination if the US scan is denied on the basis of medical necessity. Let the payer know that a thorough pelvic exam could not be completed because of the patient’s body mass; point out that obesity is a risk factor for cancer.
Making those points should help you get paid, eventually—although The Centers for Medicare & Medicaid Services (CMS) and most payers have determined that US as a confirmatory adjunct to physical examination (in the absence of an abnormal finding) will not be reimbursed.
The first question in this Reimbursement Adviser addresses a dilemma in the office-based care of obese women. For a comprehensive review of risks and remedies when an obese patient faces surgery, see "Risks and remedies when your surgical patient is obese"
Slow payment for unlisted codes for lap hysterectomy
(There is good news here: New codes for total laparoscopic hysterectomy will be available beginning January 1, 2008. Look for details on these and other changes in Reimbursement Adviser in the December 2007 issue of OBG Management.)
Of course, your other coding option is to report the unlisted code 58578 (un-listed laparoscopic procedure, uterus). If you choose that option, however, you will have to submit the operative report with the claim, along with a letter from the physician explaining why this procedure was more advantageous to the patient than LAVH. And although using an unlisted code will not mean denial of service, it will slow down payment.
No need for modifiers on self-performed US scans
Although you are acting as your own sonographer for your scans, this still represents the technical component of a scan, which is reimbursed when reporting the unmodified code for the service.
It’s “false labor” if there’s no bleeding—at any date
Colporrhaphy? Do not code for posterior repair
The code 45560, on the other hand, is listed in the digestive section of CPT and is, basically, a transanal approach procedure that has a vaginal component. It is much different than posterior colporrhaphy, and is typically performed when a patient with a rectocele has fecal incontinence.
Although 45560 does carry slightly more RVUs than 57250 (posterior colporrhaphy, repair of rectocele with or without perineorrhaphy), the physician work portion of the RVU total for both codes is now identical: 11.42.
Last, be aware: Payers consider it fraud for a surgeon to use the wrong code in this situation because it pays more, when, in fact, colporrhaphy has been performed and documented.
Patient asks for test; is that “medical necessity”?
What is the best approach to a solitary pulmonary nodule identified by chest x-ray?
Your initial risk assessment should include the patient’s smoking history, advancing age, cancer history, and chest radiography features (strength of recommendation [SOR]: A, based on a validated clinical decision rule). You’ll also need to review old chest radiographs (SOR: C, based on expert opinion). A solitary pulmonary nodule unchanged for >2 years on chest radiograph or containing benign central calcifications requires no further work-up (SOR: B, based on historical cohort studies).
While radiologists’ interpretations of a nodule’s calcification on chest radiograph and malignancy on computed tomography (CT) are incorrect in a substantial portion of cases (SOR: B, based on limited-quality diagnostic cohort studies), spiral CT with contrast is still diagnostically useful in making decisions regarding watchful waiting, needle biopsy, or surgery (SOR: B, based on a decision analysis study).
18-fluorodeoxyglucose positron emission tomography (FDG PET) is useful for assessing malignancy risk (SOR: B, based on decision analysis study), but not for solitary pulmonary nodules <1 cm (SOR: C, based on expert opinion).
Direct more costly, invasive tests to those with higher risk of malignancy
Parul Harsora, MD
Rhesa Sanni-Thomas, DO
UT Southwestern Medical Center, Dallas, Tex
Risk stratification of a solitary pulmonary nodule allows the clinician to direct more costly and invasive testing to patients with a higher probability of malignancy. Historical factors such as previous cancer, advanced age, and smoking increase suspicion for malignancy, but CT is generally warranted in all new solitary pulmonary nodules found on chest radiographs. It’s important to obtain a thorough history regarding symptoms (cough, night sweats, weight loss), occupational exposure (asbestos, bird droppings, decaying wood), travel, and comorbid conditions (especially immunocompromised states); this is likely to prove helpful in the workup.
Evidence summary
A solitary pulmonary nodule, or “coin lesion,” is an intraparenchymal finding on chest radiograph or CT that is less than 3 to 4 cm in diameter and not associated with atelectasis or adenopathy. Malignancy rates range from 15% to 75%, depending on the population studied.1 Although early detection of malignancy portends a major improvement in survival (up to 75% at 5 years following surgical resection of stage IA disease), most lung cancers progress asymptomatically until quite advanced.2
The presumed benign nature of lesions that are either unchanged over 2 years or have central calcifications is based on 3 retrospective studies from the 1950s.3-6 However, these should not be considered absolutes. A recent study revisiting the original data calculated the predictive value of benign nature based on no growth to be only 65% (95% confidence interval [CI], 47%–83%).7 Also, a study assessing the accuracy of radiologists’ assessment of calcification in solitary pulmonary nodules compared with thin-section CT found that 7% of “definitely calcified” nodules on chest radiograph lacked calcification on thin-section CT.8
Which clinical variables best predict malignancy?
The best available clinical decision rule was derived and validated from a single split population of patients with solitary pulmonary nodules.9 The outcome variable was defined as malignancy based on histologic tissue analysis or benignity by radiographic stability or resolution over 2 years. The authors did not report whether those determining outcomes and predictors were appropriately blinded.
The authors found that 3 clinical variables (age, smoking history, and cancer history) plus 3 radiographic variables (diameter, spiculation, and nodule location in the upper lobes) were independent predictors of malignancy. An online calculator using this prediction model is available at www.chestx-ray.com/SPN/ SPNProb.html.10
CT or PET?
Three comparative studies observed 8 to 12 radiologists’ readings of high-resolution CT images of 28 to 56 patients with solitary pulmonary nodules (established diagnoses by either histology or stability over time).11-13 Approximately half the nodules represented malignant lesions.
Radiologists assigned a level of confidence to their assessment of each case as benign or malignant. At a minimum, they were informed of each patient’s age and gender, and in 2 studies they also knew other information, such as the patient’s smoking and cancer histories. The study showed that the radiologists would have correctly diagnosed a pair of solitary pulmonary nodule cases, one malignant and one benign, between 75% and 83% of the time. Conversely, 17% to 25% of the time they would have diagnosed the case pair incorrectly.
A meta-analysis of 40 studies of FDG PET scanning for solitary pulmonary nodules yielded a maximum joint sensitivity and specificity of 90% (95% CI, 86.4%– 92.7%).14 The methodological quality of studies included in the meta-analysis was fair, with small sample sizes (inclusion criteria were for a minimum of 10 patients with pulmonary nodules and malignant prevalence of at least 0.5); masking was frequently incomplete.
Sensitivity of histologic/cytologic tests varies
A recent systematic review of studies evaluating patients with suspected lung cancer looked into the diagnostic sensitivity of various methods of histologic and cytologic tests.15 Researchers compared the evaluated test results to a reference standard of pathology/histology, definitive cytology, or at least 1-year radiographic follow-up.
Transbronchial needle aspiration showed a sensitivity of 67% (95% CI, 64%–70%) for peripheral lung malignancy of any size; however, only 5 studies met study criteria and their sample sizes varied greatly (n=20 to n=480). Eight studies looking at bronchoscopy (including brush or biopsy) for peripheral lung lesions <2 cm in diameter yielded a sensitivity of only 33% (95% CI, 28%–38%). In the same systematic review, 61 studies of transthoracic needle aspiration for localized pulmonary lesions of any size had a pooled sensitivity of 90% (95% CI, 88%–92%). The prevalence of malignancy in the studies ranged from 0.58 to 0.93.15 Factors affecting heterogeneity between studies included the wide range in study dates, imaging technology used, and study sizes.
What test is most cost-effective?
CT appears cost-effective when the pretest probability of malignancy is <90%; therefore, consider it on virtually all new cases of solitary pulmonary nodules.1 Also, when CT and pretest risk-assessments are discordant (eg, a patient has a low pretest probability of malignancy but his CT is suggestive of malignancy), the FDG PET scan is the most economically feasible at less than $20,000 per quality-adjusted life year.
Recommendations from others
The American College of Chest Physicians (ACCP)2 suggests pursuing no further evaluation if a nodule is unchanged for >2 years or has benign central calcifications. They recommend that physicians perform CT on every patient with a new nodule to characterize the nodule, its location, and the mediastinum. They do not recommend PET scans for nodules <1 cm. Patients who are marginal surgical candidates and have a negative PET scan should have a repeat CT scan in 3 months; serial CTs at 3, 6, 12, and 24 months are suggested, too, if prior chest radiographs are negative.
The ACCP states that transthoracic needle aspiration is not indicated in surgical candidates unless they decline surgery; then transthoracic needle aspiration or a transbronchial approach are the preferred procedure. Transthoracic needle aspiration may also be useful in establishing a diagnosis for patients who are not surgical candidates or who have a high surgical risk.
ACCP expert consensus favors the reference standard of video-assisted thoracoscopic surgery with wedge resection as the ideal method for obtaining tissue diagnosis in consenting, operable patients with solitary pulmonary nodules. Objective evidence is lacking on follow-up monitoring methods for patients with a nodule who do not have a tissue diagnosis and observation alone is chosen. ACCP expert consensus favors a 2-year follow-up with CT scanning at 3, 6, 12, and 24 months to monitor for nodule growth.2
1. Gould MK, Sanders GD, Barnett PG, et al. Cost-effectiveness of alternative management strategies for patients with solitary pulmonary nodules. Ann Intern Med 2003;138:724-735.
2. Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD. The solitary pulmonary nodule. Chest 2003;123(1 suppl):89S-96S.
3. Hood RT, Good CA, Clagett OT, McDonald JR. Solitary circumscribed lesions of lung: study of 156 cases in which resection was performed. JAMA 1953;152:1175-1181.
4. Good CA, Hood RT, McDonald JR. Significance of solitary mass in lung. AJR Am J Roentgenol 1953;70:543-554.
5. Good CA. Management of patient with solitary mass in lung. Chic Med Soc Bull 1953;55:893-896.
6. Good CA, Wilson TW. The solitary circumscribed pulmonary nodule: study of 705 cases encountered roentgenologically in a period of three and one-half years. JAMA 1958;166:210-215.
7. Yankelevitz DF, Henschke CI. Does 2-year stability imply that pulmonary nodules are benign? AJR Am J Roentgenol 1997;168:325-328.
8. Berger WG, Erly WK, Krupinski EA, Standen JR, Stern RG. The solitary pulmonary nodule on chest radiography: can we really tell if the nodule is calcified? AJR Am J Roentgenol 2001;176:201-204.
9. Swensen SG, Silverstein MD, Ilstrup DM, Schleck CD, Edell ES. The probability of malignancy in solitary pulmonary nodules: application to small radiographically intermediate nodules. Arch Intern Med 1997;157:849-855.
10. Gurney JW. Probability of malignancy in SPN [Web page]. Available at: www.chestx-ray.com/SPN/ SPNProb.html. Accessed on September 7, 2007.
11. Li F, Aoyama M, Shiraishi J, et al. Radiologists’ performance for differentiating benign from malignant lung nodules on high-resolution CT using computer-estimated likelihood of malignancy. AJR Am J Roentgenol 2004;183:1209-1215.
12. Shah SK, McNitt-Gray MF, De Zoysa KR, et al. Solitary pulmonary nodule diagnosis on CT: results of an observer study. Acad Radiol 2005;12:496-501.
13. Matsuki Y, Nakamura K, Watanabe H, Aoki T, et al. Usefulness of an artificial neural network for differentiating benign from malignant pulmonary nodules on high-resolution CT: evaluation with receiver operating characteristic analysis. AJR Am J Roentgenol 2002;178:657-663.
14. Gould MK, Maclean CC, Kuschner WG, Rydzak CE, Owens DK. Accuracy of positron emission tomography for diagnosis of pulmonary nodules and mass lesions: a meta-analysis. JAMA 2001;285:914-924.
15. Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer. Chest 2003;123:115S-128S.
Your initial risk assessment should include the patient’s smoking history, advancing age, cancer history, and chest radiography features (strength of recommendation [SOR]: A, based on a validated clinical decision rule). You’ll also need to review old chest radiographs (SOR: C, based on expert opinion). A solitary pulmonary nodule unchanged for >2 years on chest radiograph or containing benign central calcifications requires no further work-up (SOR: B, based on historical cohort studies).
While radiologists’ interpretations of a nodule’s calcification on chest radiograph and malignancy on computed tomography (CT) are incorrect in a substantial portion of cases (SOR: B, based on limited-quality diagnostic cohort studies), spiral CT with contrast is still diagnostically useful in making decisions regarding watchful waiting, needle biopsy, or surgery (SOR: B, based on a decision analysis study).
18-fluorodeoxyglucose positron emission tomography (FDG PET) is useful for assessing malignancy risk (SOR: B, based on decision analysis study), but not for solitary pulmonary nodules <1 cm (SOR: C, based on expert opinion).
Direct more costly, invasive tests to those with higher risk of malignancy
Parul Harsora, MD
Rhesa Sanni-Thomas, DO
UT Southwestern Medical Center, Dallas, Tex
Risk stratification of a solitary pulmonary nodule allows the clinician to direct more costly and invasive testing to patients with a higher probability of malignancy. Historical factors such as previous cancer, advanced age, and smoking increase suspicion for malignancy, but CT is generally warranted in all new solitary pulmonary nodules found on chest radiographs. It’s important to obtain a thorough history regarding symptoms (cough, night sweats, weight loss), occupational exposure (asbestos, bird droppings, decaying wood), travel, and comorbid conditions (especially immunocompromised states); this is likely to prove helpful in the workup.
Evidence summary
A solitary pulmonary nodule, or “coin lesion,” is an intraparenchymal finding on chest radiograph or CT that is less than 3 to 4 cm in diameter and not associated with atelectasis or adenopathy. Malignancy rates range from 15% to 75%, depending on the population studied.1 Although early detection of malignancy portends a major improvement in survival (up to 75% at 5 years following surgical resection of stage IA disease), most lung cancers progress asymptomatically until quite advanced.2
The presumed benign nature of lesions that are either unchanged over 2 years or have central calcifications is based on 3 retrospective studies from the 1950s.3-6 However, these should not be considered absolutes. A recent study revisiting the original data calculated the predictive value of benign nature based on no growth to be only 65% (95% confidence interval [CI], 47%–83%).7 Also, a study assessing the accuracy of radiologists’ assessment of calcification in solitary pulmonary nodules compared with thin-section CT found that 7% of “definitely calcified” nodules on chest radiograph lacked calcification on thin-section CT.8
Which clinical variables best predict malignancy?
The best available clinical decision rule was derived and validated from a single split population of patients with solitary pulmonary nodules.9 The outcome variable was defined as malignancy based on histologic tissue analysis or benignity by radiographic stability or resolution over 2 years. The authors did not report whether those determining outcomes and predictors were appropriately blinded.
The authors found that 3 clinical variables (age, smoking history, and cancer history) plus 3 radiographic variables (diameter, spiculation, and nodule location in the upper lobes) were independent predictors of malignancy. An online calculator using this prediction model is available at www.chestx-ray.com/SPN/ SPNProb.html.10
CT or PET?
Three comparative studies observed 8 to 12 radiologists’ readings of high-resolution CT images of 28 to 56 patients with solitary pulmonary nodules (established diagnoses by either histology or stability over time).11-13 Approximately half the nodules represented malignant lesions.
Radiologists assigned a level of confidence to their assessment of each case as benign or malignant. At a minimum, they were informed of each patient’s age and gender, and in 2 studies they also knew other information, such as the patient’s smoking and cancer histories. The study showed that the radiologists would have correctly diagnosed a pair of solitary pulmonary nodule cases, one malignant and one benign, between 75% and 83% of the time. Conversely, 17% to 25% of the time they would have diagnosed the case pair incorrectly.
A meta-analysis of 40 studies of FDG PET scanning for solitary pulmonary nodules yielded a maximum joint sensitivity and specificity of 90% (95% CI, 86.4%– 92.7%).14 The methodological quality of studies included in the meta-analysis was fair, with small sample sizes (inclusion criteria were for a minimum of 10 patients with pulmonary nodules and malignant prevalence of at least 0.5); masking was frequently incomplete.
Sensitivity of histologic/cytologic tests varies
A recent systematic review of studies evaluating patients with suspected lung cancer looked into the diagnostic sensitivity of various methods of histologic and cytologic tests.15 Researchers compared the evaluated test results to a reference standard of pathology/histology, definitive cytology, or at least 1-year radiographic follow-up.
Transbronchial needle aspiration showed a sensitivity of 67% (95% CI, 64%–70%) for peripheral lung malignancy of any size; however, only 5 studies met study criteria and their sample sizes varied greatly (n=20 to n=480). Eight studies looking at bronchoscopy (including brush or biopsy) for peripheral lung lesions <2 cm in diameter yielded a sensitivity of only 33% (95% CI, 28%–38%). In the same systematic review, 61 studies of transthoracic needle aspiration for localized pulmonary lesions of any size had a pooled sensitivity of 90% (95% CI, 88%–92%). The prevalence of malignancy in the studies ranged from 0.58 to 0.93.15 Factors affecting heterogeneity between studies included the wide range in study dates, imaging technology used, and study sizes.
What test is most cost-effective?
CT appears cost-effective when the pretest probability of malignancy is <90%; therefore, consider it on virtually all new cases of solitary pulmonary nodules.1 Also, when CT and pretest risk-assessments are discordant (eg, a patient has a low pretest probability of malignancy but his CT is suggestive of malignancy), the FDG PET scan is the most economically feasible at less than $20,000 per quality-adjusted life year.
Recommendations from others
The American College of Chest Physicians (ACCP)2 suggests pursuing no further evaluation if a nodule is unchanged for >2 years or has benign central calcifications. They recommend that physicians perform CT on every patient with a new nodule to characterize the nodule, its location, and the mediastinum. They do not recommend PET scans for nodules <1 cm. Patients who are marginal surgical candidates and have a negative PET scan should have a repeat CT scan in 3 months; serial CTs at 3, 6, 12, and 24 months are suggested, too, if prior chest radiographs are negative.
The ACCP states that transthoracic needle aspiration is not indicated in surgical candidates unless they decline surgery; then transthoracic needle aspiration or a transbronchial approach are the preferred procedure. Transthoracic needle aspiration may also be useful in establishing a diagnosis for patients who are not surgical candidates or who have a high surgical risk.
ACCP expert consensus favors the reference standard of video-assisted thoracoscopic surgery with wedge resection as the ideal method for obtaining tissue diagnosis in consenting, operable patients with solitary pulmonary nodules. Objective evidence is lacking on follow-up monitoring methods for patients with a nodule who do not have a tissue diagnosis and observation alone is chosen. ACCP expert consensus favors a 2-year follow-up with CT scanning at 3, 6, 12, and 24 months to monitor for nodule growth.2
Your initial risk assessment should include the patient’s smoking history, advancing age, cancer history, and chest radiography features (strength of recommendation [SOR]: A, based on a validated clinical decision rule). You’ll also need to review old chest radiographs (SOR: C, based on expert opinion). A solitary pulmonary nodule unchanged for >2 years on chest radiograph or containing benign central calcifications requires no further work-up (SOR: B, based on historical cohort studies).
While radiologists’ interpretations of a nodule’s calcification on chest radiograph and malignancy on computed tomography (CT) are incorrect in a substantial portion of cases (SOR: B, based on limited-quality diagnostic cohort studies), spiral CT with contrast is still diagnostically useful in making decisions regarding watchful waiting, needle biopsy, or surgery (SOR: B, based on a decision analysis study).
18-fluorodeoxyglucose positron emission tomography (FDG PET) is useful for assessing malignancy risk (SOR: B, based on decision analysis study), but not for solitary pulmonary nodules <1 cm (SOR: C, based on expert opinion).
Direct more costly, invasive tests to those with higher risk of malignancy
Parul Harsora, MD
Rhesa Sanni-Thomas, DO
UT Southwestern Medical Center, Dallas, Tex
Risk stratification of a solitary pulmonary nodule allows the clinician to direct more costly and invasive testing to patients with a higher probability of malignancy. Historical factors such as previous cancer, advanced age, and smoking increase suspicion for malignancy, but CT is generally warranted in all new solitary pulmonary nodules found on chest radiographs. It’s important to obtain a thorough history regarding symptoms (cough, night sweats, weight loss), occupational exposure (asbestos, bird droppings, decaying wood), travel, and comorbid conditions (especially immunocompromised states); this is likely to prove helpful in the workup.
Evidence summary
A solitary pulmonary nodule, or “coin lesion,” is an intraparenchymal finding on chest radiograph or CT that is less than 3 to 4 cm in diameter and not associated with atelectasis or adenopathy. Malignancy rates range from 15% to 75%, depending on the population studied.1 Although early detection of malignancy portends a major improvement in survival (up to 75% at 5 years following surgical resection of stage IA disease), most lung cancers progress asymptomatically until quite advanced.2
The presumed benign nature of lesions that are either unchanged over 2 years or have central calcifications is based on 3 retrospective studies from the 1950s.3-6 However, these should not be considered absolutes. A recent study revisiting the original data calculated the predictive value of benign nature based on no growth to be only 65% (95% confidence interval [CI], 47%–83%).7 Also, a study assessing the accuracy of radiologists’ assessment of calcification in solitary pulmonary nodules compared with thin-section CT found that 7% of “definitely calcified” nodules on chest radiograph lacked calcification on thin-section CT.8
Which clinical variables best predict malignancy?
The best available clinical decision rule was derived and validated from a single split population of patients with solitary pulmonary nodules.9 The outcome variable was defined as malignancy based on histologic tissue analysis or benignity by radiographic stability or resolution over 2 years. The authors did not report whether those determining outcomes and predictors were appropriately blinded.
The authors found that 3 clinical variables (age, smoking history, and cancer history) plus 3 radiographic variables (diameter, spiculation, and nodule location in the upper lobes) were independent predictors of malignancy. An online calculator using this prediction model is available at www.chestx-ray.com/SPN/ SPNProb.html.10
CT or PET?
Three comparative studies observed 8 to 12 radiologists’ readings of high-resolution CT images of 28 to 56 patients with solitary pulmonary nodules (established diagnoses by either histology or stability over time).11-13 Approximately half the nodules represented malignant lesions.
Radiologists assigned a level of confidence to their assessment of each case as benign or malignant. At a minimum, they were informed of each patient’s age and gender, and in 2 studies they also knew other information, such as the patient’s smoking and cancer histories. The study showed that the radiologists would have correctly diagnosed a pair of solitary pulmonary nodule cases, one malignant and one benign, between 75% and 83% of the time. Conversely, 17% to 25% of the time they would have diagnosed the case pair incorrectly.
A meta-analysis of 40 studies of FDG PET scanning for solitary pulmonary nodules yielded a maximum joint sensitivity and specificity of 90% (95% CI, 86.4%– 92.7%).14 The methodological quality of studies included in the meta-analysis was fair, with small sample sizes (inclusion criteria were for a minimum of 10 patients with pulmonary nodules and malignant prevalence of at least 0.5); masking was frequently incomplete.
Sensitivity of histologic/cytologic tests varies
A recent systematic review of studies evaluating patients with suspected lung cancer looked into the diagnostic sensitivity of various methods of histologic and cytologic tests.15 Researchers compared the evaluated test results to a reference standard of pathology/histology, definitive cytology, or at least 1-year radiographic follow-up.
Transbronchial needle aspiration showed a sensitivity of 67% (95% CI, 64%–70%) for peripheral lung malignancy of any size; however, only 5 studies met study criteria and their sample sizes varied greatly (n=20 to n=480). Eight studies looking at bronchoscopy (including brush or biopsy) for peripheral lung lesions <2 cm in diameter yielded a sensitivity of only 33% (95% CI, 28%–38%). In the same systematic review, 61 studies of transthoracic needle aspiration for localized pulmonary lesions of any size had a pooled sensitivity of 90% (95% CI, 88%–92%). The prevalence of malignancy in the studies ranged from 0.58 to 0.93.15 Factors affecting heterogeneity between studies included the wide range in study dates, imaging technology used, and study sizes.
What test is most cost-effective?
CT appears cost-effective when the pretest probability of malignancy is <90%; therefore, consider it on virtually all new cases of solitary pulmonary nodules.1 Also, when CT and pretest risk-assessments are discordant (eg, a patient has a low pretest probability of malignancy but his CT is suggestive of malignancy), the FDG PET scan is the most economically feasible at less than $20,000 per quality-adjusted life year.
Recommendations from others
The American College of Chest Physicians (ACCP)2 suggests pursuing no further evaluation if a nodule is unchanged for >2 years or has benign central calcifications. They recommend that physicians perform CT on every patient with a new nodule to characterize the nodule, its location, and the mediastinum. They do not recommend PET scans for nodules <1 cm. Patients who are marginal surgical candidates and have a negative PET scan should have a repeat CT scan in 3 months; serial CTs at 3, 6, 12, and 24 months are suggested, too, if prior chest radiographs are negative.
The ACCP states that transthoracic needle aspiration is not indicated in surgical candidates unless they decline surgery; then transthoracic needle aspiration or a transbronchial approach are the preferred procedure. Transthoracic needle aspiration may also be useful in establishing a diagnosis for patients who are not surgical candidates or who have a high surgical risk.
ACCP expert consensus favors the reference standard of video-assisted thoracoscopic surgery with wedge resection as the ideal method for obtaining tissue diagnosis in consenting, operable patients with solitary pulmonary nodules. Objective evidence is lacking on follow-up monitoring methods for patients with a nodule who do not have a tissue diagnosis and observation alone is chosen. ACCP expert consensus favors a 2-year follow-up with CT scanning at 3, 6, 12, and 24 months to monitor for nodule growth.2
1. Gould MK, Sanders GD, Barnett PG, et al. Cost-effectiveness of alternative management strategies for patients with solitary pulmonary nodules. Ann Intern Med 2003;138:724-735.
2. Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD. The solitary pulmonary nodule. Chest 2003;123(1 suppl):89S-96S.
3. Hood RT, Good CA, Clagett OT, McDonald JR. Solitary circumscribed lesions of lung: study of 156 cases in which resection was performed. JAMA 1953;152:1175-1181.
4. Good CA, Hood RT, McDonald JR. Significance of solitary mass in lung. AJR Am J Roentgenol 1953;70:543-554.
5. Good CA. Management of patient with solitary mass in lung. Chic Med Soc Bull 1953;55:893-896.
6. Good CA, Wilson TW. The solitary circumscribed pulmonary nodule: study of 705 cases encountered roentgenologically in a period of three and one-half years. JAMA 1958;166:210-215.
7. Yankelevitz DF, Henschke CI. Does 2-year stability imply that pulmonary nodules are benign? AJR Am J Roentgenol 1997;168:325-328.
8. Berger WG, Erly WK, Krupinski EA, Standen JR, Stern RG. The solitary pulmonary nodule on chest radiography: can we really tell if the nodule is calcified? AJR Am J Roentgenol 2001;176:201-204.
9. Swensen SG, Silverstein MD, Ilstrup DM, Schleck CD, Edell ES. The probability of malignancy in solitary pulmonary nodules: application to small radiographically intermediate nodules. Arch Intern Med 1997;157:849-855.
10. Gurney JW. Probability of malignancy in SPN [Web page]. Available at: www.chestx-ray.com/SPN/ SPNProb.html. Accessed on September 7, 2007.
11. Li F, Aoyama M, Shiraishi J, et al. Radiologists’ performance for differentiating benign from malignant lung nodules on high-resolution CT using computer-estimated likelihood of malignancy. AJR Am J Roentgenol 2004;183:1209-1215.
12. Shah SK, McNitt-Gray MF, De Zoysa KR, et al. Solitary pulmonary nodule diagnosis on CT: results of an observer study. Acad Radiol 2005;12:496-501.
13. Matsuki Y, Nakamura K, Watanabe H, Aoki T, et al. Usefulness of an artificial neural network for differentiating benign from malignant pulmonary nodules on high-resolution CT: evaluation with receiver operating characteristic analysis. AJR Am J Roentgenol 2002;178:657-663.
14. Gould MK, Maclean CC, Kuschner WG, Rydzak CE, Owens DK. Accuracy of positron emission tomography for diagnosis of pulmonary nodules and mass lesions: a meta-analysis. JAMA 2001;285:914-924.
15. Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer. Chest 2003;123:115S-128S.
1. Gould MK, Sanders GD, Barnett PG, et al. Cost-effectiveness of alternative management strategies for patients with solitary pulmonary nodules. Ann Intern Med 2003;138:724-735.
2. Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD. The solitary pulmonary nodule. Chest 2003;123(1 suppl):89S-96S.
3. Hood RT, Good CA, Clagett OT, McDonald JR. Solitary circumscribed lesions of lung: study of 156 cases in which resection was performed. JAMA 1953;152:1175-1181.
4. Good CA, Hood RT, McDonald JR. Significance of solitary mass in lung. AJR Am J Roentgenol 1953;70:543-554.
5. Good CA. Management of patient with solitary mass in lung. Chic Med Soc Bull 1953;55:893-896.
6. Good CA, Wilson TW. The solitary circumscribed pulmonary nodule: study of 705 cases encountered roentgenologically in a period of three and one-half years. JAMA 1958;166:210-215.
7. Yankelevitz DF, Henschke CI. Does 2-year stability imply that pulmonary nodules are benign? AJR Am J Roentgenol 1997;168:325-328.
8. Berger WG, Erly WK, Krupinski EA, Standen JR, Stern RG. The solitary pulmonary nodule on chest radiography: can we really tell if the nodule is calcified? AJR Am J Roentgenol 2001;176:201-204.
9. Swensen SG, Silverstein MD, Ilstrup DM, Schleck CD, Edell ES. The probability of malignancy in solitary pulmonary nodules: application to small radiographically intermediate nodules. Arch Intern Med 1997;157:849-855.
10. Gurney JW. Probability of malignancy in SPN [Web page]. Available at: www.chestx-ray.com/SPN/ SPNProb.html. Accessed on September 7, 2007.
11. Li F, Aoyama M, Shiraishi J, et al. Radiologists’ performance for differentiating benign from malignant lung nodules on high-resolution CT using computer-estimated likelihood of malignancy. AJR Am J Roentgenol 2004;183:1209-1215.
12. Shah SK, McNitt-Gray MF, De Zoysa KR, et al. Solitary pulmonary nodule diagnosis on CT: results of an observer study. Acad Radiol 2005;12:496-501.
13. Matsuki Y, Nakamura K, Watanabe H, Aoki T, et al. Usefulness of an artificial neural network for differentiating benign from malignant pulmonary nodules on high-resolution CT: evaluation with receiver operating characteristic analysis. AJR Am J Roentgenol 2002;178:657-663.
14. Gould MK, Maclean CC, Kuschner WG, Rydzak CE, Owens DK. Accuracy of positron emission tomography for diagnosis of pulmonary nodules and mass lesions: a meta-analysis. JAMA 2001;285:914-924.
15. Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer. Chest 2003;123:115S-128S.
Evidence-based answers from the Family Physicians Inquiries Network
Genetic screening for iron overload: No evidence of discrimination at 1 year
Purpose This study measured the extent of insurance and employment problems associated with population screening for hereditary hemochromatosis and iron overload.
Methods 101,168 primary care patients from the US and Canada were screened for iron phenotypes and HFE genotypes associated with hemochromatosis. Those identified to be at risk (2253) were offered a clinical examination, which 1677 (74%) accepted, and the 1154 of these who responded to an initial questionnaire about psychosocial issues were surveyed 1 year later about whether they had experienced problems with insurance or employment that they attributed to hereditary hemochromatosis and iron overload.
Results 832 (72.1%) of the 1154 participants surveyed after 1 year responded to the second survey. Three (0.4%) had verified problems with insurance or employment that they believed were related to hereditary hemochromatosis and iron overload. Two had problems with life insurance, and one with long-term care insurance. All 3 had elevated iron levels but not a relevant HFE genotype. One of the life insurance problems was resolved; the second one was not serious. The participant who was denied long-term care insurance had other health conditions unrelated to hereditary hemochromatosis and iron overload that could have contributed to the denial. No problems were verified for health insurance or employment, or from any of the comparison group participants (controls and those with inconclusive screening results).
Conclusions The risk of insurance or employment problems 1 year after phenotype and genotype screening for hereditary hemochromatosis and iron overload is very low.
Social risks from genetic testing are a major public policy concern in medical genetics and genetics research.1-3 These concerns are focused mainly on health insurance, as insurers have an incentive to avoid those clients it will be costly for them to insure. This concern also applies to employers, who pay for most private health care in the US.
Since the beginnings of the Human Genome Project in 1990, legislation has been proposed to head off possible genetic discrimination. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibited most insurers from considering genetic risks as preexisting conditions. Since the 1990s, all but 2 states have passed laws that limit genetic discrimination in health insurance; 34 states ban or limit genetic discrimination by employers.4 In addition, a piece of federal legislation is pending. The Genetic Information Nondiscrimination Act, intended to prohibit health insurance and employment discrimination on the basis of genetic information, passed the House in April 2007 but, at press time, had not been voted on by the Senate.
Because state laws usually do not apply to life or disability insurance, and their applicability to employment is inconsistent, the potential for discrimination problems is still of concern to patients with costly conditions that may be uncovered by genetic screening.
Hereditary hemochromatosis—early detection is key
Members of the health care community have expressed concern that genetic discrimination will hamper efforts to detect and mitigate hereditary hemochromatosis, a relatively common condition marked by iron overload, which can lead to irreversible organ damage and related health problems.5-9 Hereditary hemochromatosis is an autosomal recessive condition that typically is associated with 2 copies of the C282Y mutation in the HFE gene on chromosome 6, although the H63D HFE mutation is also associated with hereditary hemochromatosis in some cases.10,11 If detected early, health problems from iron overload can be prevented by periodic phlebotomy. Not surprisingly, then, there is public health interest in the screening and detection of hemochromatosis or iron overload before symptoms arise.9,12-14
There are documented instances, however, of healthy people who experienced discrimination in insurance or employment based on having a phenotype or genotype associated with hereditary hemochromatosis.8,15,16 Alper and colleagues noted that “[i]n a general screening program of 100 million people…even if only 5% of these people [who screen positive for hereditary hemochromatosis] encounter discrimination, this amounts to approximately 28,000 people.”8 Alper’s speculation has not been tested because no large-scale studies of discrimination resulting from screening the general population have been conducted.
This study looks to identify possible social risks from genetic screening by surveying a large and diverse racial/ethnic primary care population participating in a study of iron overload and hereditary hemochromatosis in the US and Canada. We have sought to determine the number and types of problems associated with insurance and employment 1 year after screening and clinical examination for relevant hereditary hemochromatosis phenotypes and genotypes.
Methods
The data for this analysis come from the Hemochromatosis and Iron Overload Screening (HEIRS) Study. A full description of the study’s rationale, design, and methods has been published elsewhere.17
Identifying the subjects
The research team screened a multiracial/ethnic sample of 101,168 primary care patients, 25 years of age and older, over a 2-year period beginning in March 2001. We recruited participants in approximately equal numbers at 5 field centers, 4 in the US and 1 in Canada. We chose study sites and recruitment goals to produce a sample with about 50% non-Caucasians. A central laboratory assayed blood samples for transferrin saturation, serum ferritin, and HFE C282Y and H63D mutations. A comprehensive clinical evaluation was offered to all C282Y homozygotes and to all non-C282Y homozygotes who met study thresholds for elevated transferrin saturation and serum ferritin iron measures.17
We identified a total of 2253 such participants. Of these, 1677 (74%) participated in the clinical exam, which assessed body iron stores and attempted to distinguish between primary and secondary causes of iron overload. Clinical exam results were provided to the participants—and, if they consented, to their primary care providers. We then mailed an extended survey to all 1677 participants assessing various psychological and behavioral issues related to genetic screening and testing; 1154 responded (68.8%).
Follow-up 1 year later
One year after the clinical exam, we resurveyed these 1154 respondents and asked additional questions about any problems with employment or insurance (health, life, or disability) in the past year “related to hemochromatosis or iron overload.” Participants who had problems were contacted by telephone for follow-up questions about the nature and circumstances of the problem.
For comparison with clinical exam participants, we surveyed a stratified random sample of 939 screening participants in a similar fashion 1 year following screening. These participants were not eligible for a clinical exam but they had inconclusive screening results, indicating possible elevated risk of hereditary hemochromatosis/iron overload, such as HFE genotypes other than C282Y homozygosity, or lesser elevations of transferrin saturation or serum ferritin.18 Also surveyed at 1 year were 803 controls (469 of whom had a clinical exam and 334 who did not), who were randomly selected following the age distribution of the other participants. All controls had no known HFE genotypes associated with iron overload and had transferrin saturation and serum ferritin values below study-defined thresholds for risk of iron overload.
Results
Overall, 832 clinical exam participants (72.1%) responded among the 1154 who were surveyed 1 year after their exam. Sample characteristics are shown in TABLE 1.
Few discrimination problems were found
Twenty-four (2.8%) reported they had 1 or more problems with employment or insurance that they believed were related to hereditary hemochromatosis/iron overload. Researchers made follow-up phone contact with 17 of these (70.8%), but 7 were lost to follow-up. Only 3 of these 17 participants verified problems that were possibly related to the participation in the HEIRS Study. Among the comparison group respondents (controls and inconclusive screening results), 6 (0.5%) reported a problem with employment or insurance. However, after we made contact with 5 of the 6 respondents, we were unable to verify any of the 5 cases.
All 3 verified reports of problems came from participants who received a clinical exam based on elevated transferrin saturation and serum ferritin levels, rather than based on their HFE genotypes. There were no verified reports from any of the 153 newly identified C282Y homozygotes who responded (out of a total of 252 such participants in the HEIRS Study). Details of the 3 verified problems are shown in TABLE 2.
One person with primary iron overload was denied long-term care insurance. Two people with elevated transferrin saturation and serum ferritin levels of undetermined cause reported having problems with life insurance. One was charged an increased rate, and the second one was initially refused insurance but was later covered after a physician explained that serum iron measures had returned to normal. There were no verified reports of problems with health insurance or employment. (None of the 7 participants who reported problems but who were lost to further follow-up were newly identified C282Y homozygotes, nor did any have C282Y or H63D HFE mutations.)
TABLE 1
Characteristics of all who responded to follow-up
CLINICAL EXAM | COMPARISON GROUPS | |
---|---|---|
Number of follow-up surveys | 1154 | 1742 |
Number (%) of respondents | 832 (72.1) | 1130 (64.9) |
Age: mean (SD) | 56.5 years (13.4) | 53.2 years (13.6) |
Gender: N (%)* | ||
Male | 439 (52.8) | 357 (31.7) |
Female | 393 (47.2) | 768 (68.3) |
Race: N (%) | ||
White | 461 (55.4) | 788 (69.7) |
Other | 371 (44.6) | 342 (30.3) |
Language: N (%)* | ||
English | 728 (87.5) | 1027 (91.4) |
Other | 104 (12.5) | 97 (8.6) |
Insurance coverage: N (%)* | ||
Disability insurance | 240 (31.1) | 391 (37.1) |
Life insurance | 494 (62.2) | 736 (67.8) |
Health insurance | 678 (83.4) | 980 (88.7) |
Employed: N (%)* | 394 (55.7) | 646 (65.5) |
* Not all survey respondents answered these questions. Percent is based on those who answered. |
Discussion
Legal definitions and jurisdictions: Their role in discrimination
In the present study, all 3 participants who reported problems received a clinical examination based on elevated blood iron measures (transferrin saturation and serum ferritin). We verified no problems among participants with any C282Y or H63D HFE genotypes (including both homozygotes or heterozygotes). Therefore, under prevailing definitions, the reported problems do not appear to constitute “genetic discrimination.”15 Furthermore, we received no verified reports of problems with employment or health insurance, for which legal protections are much stronger than for other types of potential discrimination.19
Of note, though: None of our study jurisdictions had legal protections against genetic discrimination by life insurers or long-term-care insurers, and these are the 2 areas where our participants encountered problems. This suggests that existing legal protections may be somewhat effective, although it is also consistent with the argument that such protections address potential problems that are rare or nonexistent.1
Examining the individual case reports (TABLE 2), insurance was denied outright in just one case, involving long-term care insurance, and that participant had health problems unrelated to iron overload that could have contributed to the denial. In the 2 life insurance cases, one person was insured with the help of a physician’s letter, and the other person obtained insurance with an increased premium.
TABLE 2
Characteristics of the 3 participants reporting insurance problems
Race | Caucasian, Asian, Pacific Islander (one each) | ||
Gender | Two males and one female | ||
PARTICIPANT 1 | PARTICIPANT 2 | PARTICIPANT 3 | |
Age | over 64 | 45–64 | 45–64 |
Genotype | normal (wild-type) HFE | normal (wild-type) HFE | normal (wild-type) HFE |
Phenotype | Elevated transferrin saturation (51%) and serum ferritin (917 mcg/L) | Elevated transferrin saturation (53%) serum ferritin (740 mcg/L) | Elevated transferrin saturation (76%) and serum ferritin (2871 mcg/L) |
Other health problems | Obese; spherocytosis; reported history of arrhythmia | Reported history of thalassemia trait | Reports 5 alcohol servings per day; evidence of liver abnormality |
Study classification | Primary iron overload | Cause of iron overload indeterminate | Cause of iron overload indeterminate |
Reported problem | Denied long-term-care insurance by 2 large companies | Obtained life insurance but at an increased rate | Initially denied life insurance, but successfully appealed with a physician’s letter stating no iron overload |
Notes | Self-rated health status of 2 (“fair”) out of 5 (“excellent”) | Participant believes this was not due to participation in HEIRS Study, but was due to iron elevations that were identified by the study and reconfirmed by independent testing done for the insurance company | Reports that iron level returned to normal after ceasing to drink red wine |
Limitations of this study
Because this study had only a 1-year follow-up period, it provides no basis for determining the long-term prevalence of insurance or employment problems. However, it appears that after 1 year, the extent of these problems is very small. No verified problems were reported by newly identified C282Y homozygotes or by participants with any other C282Y or H63D HFE genotypes.
Our findings contrast with the 20% prevalence of discrimination among hemochromatosis patients reported by Shaheen et al.16 Their study, however, evaluated subjects who had been diagnosed in routine medical care to have hemochromatosis an average of 4.5 years before discrimination evaluation, and who were under treatment for iron overload.
Verification contacts in our study were made with those reporting a problem, which may have resulted in some underreporting among respondents. Also, we did not determine which participants sought or changed insurance during the study period, so we do not know the exposure rate to potential discrimination. Nevertheless, these findings provide some empirical basis for informing clinicians, researchers, patients, and Institution Review Boards that the risk of insurance or employment problems following genetic screening for hemochromatosis appears to be quite small.
Funding/Support
This study is supported by contracts N01-HC05185 (University of Minnesota), N01-HC05186 (Howard University), N01-HC05188 (University of Alabama at Birmingham), N01-HC05189 (Kaiser Permanente Center for Health Research), N01-HC05190 (University of California, Irvine), N01-HC05191 (London Health Sciences Centre), and N01-HC05192 (Wake Forest University).
Additional support was provided by the Howard University General Clinical Research Center (GCRC) grant, M01-RR 10284, and the UCSD/UCI Satellite GCRC grant, M01-RR 00827 (University of California, Irvine), sponsored by the National Center for Research Resources, National Institutes of Health. Additional support was provided by the University of Alabama at Birmingham General Clinical Research Center (GCRC) grant M01-RR 00032, Southern Iron Disorders Center, Howard University GCRC grant M01-RR 10284, Howard University Research Scientist Award UH1-HL03679-05 from the National Heart, Lung, and Blood Institute and the Office of Research on Minority Health; and grant UC Irvine M01 RR 000827 from the General Clinical Research Centers Program of the National Center for Research Resources National Institutes of Health. These funding organizations participated in the study’s design and conduct, and they approved publication of this paper, but they did not directly participate in the collection, management, analysis, or interpretation of the data or the preparation of this manuscript.
All authors had full access to all of the data in the study and they take responsibility for the integrity of the data and the accuracy of the data analysis.
The HEIRS Study investigators are listed at www.heirs-study.org/PP_Policy.htm.
CorrespondenceMark A. Hall, JD, Wake Forest University Medical School, Department of Public Health Sciences, 2000 W. 1st Street, Winston-Salem NC 27157-1063; [email protected].
1. Greely HT. Banning genetic discrimination. N Engl J Med 2005;353:865-867.
2. Hudson KL, Rothenberg KH, Andrews LB, Kahn MJ, Collins FS. Genetic discrimination and health insurance: an urgent need for reform. Science 1995;270:391-393.
3. Billings PR, Kohn MA, de Cuevas M, Beckwith J, Alper JS, Natowicz MR. Discrimination as a consequence of genetic testing. Am J Hum Genetics 1992;50:476-482.
4. National Conference of State Legislatures. Genetics laws and legislative activity. Available at: www.ncsl.org/programs/health/genetics/charts.htm. Accessed on September 14, 2007.
5. Cogswell ME, McDonnell SM, Khoury MJ, Franks AL, Burke W, Brittenham G. Iron overload, public health, and genetics: Evaluating the evidence for hemochromatosis screening. Ann Intern Med 1998;129:971-979.
6. Delatycki MB, Allen KJ, Nisselle AE, et al. Use of community genetic screening to prevent HFE-associated hereditary haemochromatosis. Lancet 2005;366:314-316.
7. Qaseem A, Aronson M, Fitterman N, et al. Screening for hereditary hemochromatosis: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2005;143:517-521.
8. Alper JS, Geller LN, Barash CI, Billings PR, Laden V, Natowicz MR. Genetic discrimination and screening for hemochromatosis. J Pub Health Pol 1994;15:345-358.
9. Burke W, Thomson E, Khoury MJ, McDonnell SM, Press N, Adams PC. Hereditary hemochromatosis: gene discovery and its implications for population-based screening. JAMA 1998;280:172-178.
10. Hanson EH, Imperatore G, Burke W. HFE Gene and Hereditary Hemochromatosis: A HuGE Review. Am J Epidemiol 2001;154:193-206.
11. Adams PC, Walker AP, Acton RT. A primer for predicting risk of disease in HFE-linked hemochromatosis. Genetic Testing 2001;5:311-316.
12. Adams PC. Population screening for hemochromatosis. Gut 2000;46:301-303.
13. Barton JC, Acton RT. Population screening for hemochromatosis: Has the time finally come? Curr Gastroenterol Rep 2000;2:1-9.
14. McDonnell SM, Phatak PD, Felitti V, Hover A, McLaren GD. Screening for hemochromatosis in primary care settings. Ann Intern Med 1998;129:962-970.
15. Barash CI. Genetic discrimination and screening for hemochromatosis: then and now. Genetic Testing 2000;4:213-218.
16. Shaheen NJ, Lawrence LB, Bacon BR, et al. Insurance, employment and psychosocial consequences of a diagnosis of hereditary hemochromatosis in subjects without end organ damage. Am J Gastroenterol 2003;98:1175-1180.
17. McLaren CE, Barton JC, Adams PC, et al. Hemochromatosis and Iron Overload Screening (HEIRS). Study design for an evaluation of 100,000 primary care-based adults. Am J Med Sci 2003;325:53-62.
18. Anderson RT, Wenzel L, Walker AP, et al. Impact of hemochromatosis screening in patients with indeterminate results: the hemochromatosis and iron overload screening study. Genet Med 2006;8:681-687.
19. Hellman D. What makes genetic discrimination exceptional? Am J Law Med 2003;29:77-116.
Purpose This study measured the extent of insurance and employment problems associated with population screening for hereditary hemochromatosis and iron overload.
Methods 101,168 primary care patients from the US and Canada were screened for iron phenotypes and HFE genotypes associated with hemochromatosis. Those identified to be at risk (2253) were offered a clinical examination, which 1677 (74%) accepted, and the 1154 of these who responded to an initial questionnaire about psychosocial issues were surveyed 1 year later about whether they had experienced problems with insurance or employment that they attributed to hereditary hemochromatosis and iron overload.
Results 832 (72.1%) of the 1154 participants surveyed after 1 year responded to the second survey. Three (0.4%) had verified problems with insurance or employment that they believed were related to hereditary hemochromatosis and iron overload. Two had problems with life insurance, and one with long-term care insurance. All 3 had elevated iron levels but not a relevant HFE genotype. One of the life insurance problems was resolved; the second one was not serious. The participant who was denied long-term care insurance had other health conditions unrelated to hereditary hemochromatosis and iron overload that could have contributed to the denial. No problems were verified for health insurance or employment, or from any of the comparison group participants (controls and those with inconclusive screening results).
Conclusions The risk of insurance or employment problems 1 year after phenotype and genotype screening for hereditary hemochromatosis and iron overload is very low.
Social risks from genetic testing are a major public policy concern in medical genetics and genetics research.1-3 These concerns are focused mainly on health insurance, as insurers have an incentive to avoid those clients it will be costly for them to insure. This concern also applies to employers, who pay for most private health care in the US.
Since the beginnings of the Human Genome Project in 1990, legislation has been proposed to head off possible genetic discrimination. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibited most insurers from considering genetic risks as preexisting conditions. Since the 1990s, all but 2 states have passed laws that limit genetic discrimination in health insurance; 34 states ban or limit genetic discrimination by employers.4 In addition, a piece of federal legislation is pending. The Genetic Information Nondiscrimination Act, intended to prohibit health insurance and employment discrimination on the basis of genetic information, passed the House in April 2007 but, at press time, had not been voted on by the Senate.
Because state laws usually do not apply to life or disability insurance, and their applicability to employment is inconsistent, the potential for discrimination problems is still of concern to patients with costly conditions that may be uncovered by genetic screening.
Hereditary hemochromatosis—early detection is key
Members of the health care community have expressed concern that genetic discrimination will hamper efforts to detect and mitigate hereditary hemochromatosis, a relatively common condition marked by iron overload, which can lead to irreversible organ damage and related health problems.5-9 Hereditary hemochromatosis is an autosomal recessive condition that typically is associated with 2 copies of the C282Y mutation in the HFE gene on chromosome 6, although the H63D HFE mutation is also associated with hereditary hemochromatosis in some cases.10,11 If detected early, health problems from iron overload can be prevented by periodic phlebotomy. Not surprisingly, then, there is public health interest in the screening and detection of hemochromatosis or iron overload before symptoms arise.9,12-14
There are documented instances, however, of healthy people who experienced discrimination in insurance or employment based on having a phenotype or genotype associated with hereditary hemochromatosis.8,15,16 Alper and colleagues noted that “[i]n a general screening program of 100 million people…even if only 5% of these people [who screen positive for hereditary hemochromatosis] encounter discrimination, this amounts to approximately 28,000 people.”8 Alper’s speculation has not been tested because no large-scale studies of discrimination resulting from screening the general population have been conducted.
This study looks to identify possible social risks from genetic screening by surveying a large and diverse racial/ethnic primary care population participating in a study of iron overload and hereditary hemochromatosis in the US and Canada. We have sought to determine the number and types of problems associated with insurance and employment 1 year after screening and clinical examination for relevant hereditary hemochromatosis phenotypes and genotypes.
Methods
The data for this analysis come from the Hemochromatosis and Iron Overload Screening (HEIRS) Study. A full description of the study’s rationale, design, and methods has been published elsewhere.17
Identifying the subjects
The research team screened a multiracial/ethnic sample of 101,168 primary care patients, 25 years of age and older, over a 2-year period beginning in March 2001. We recruited participants in approximately equal numbers at 5 field centers, 4 in the US and 1 in Canada. We chose study sites and recruitment goals to produce a sample with about 50% non-Caucasians. A central laboratory assayed blood samples for transferrin saturation, serum ferritin, and HFE C282Y and H63D mutations. A comprehensive clinical evaluation was offered to all C282Y homozygotes and to all non-C282Y homozygotes who met study thresholds for elevated transferrin saturation and serum ferritin iron measures.17
We identified a total of 2253 such participants. Of these, 1677 (74%) participated in the clinical exam, which assessed body iron stores and attempted to distinguish between primary and secondary causes of iron overload. Clinical exam results were provided to the participants—and, if they consented, to their primary care providers. We then mailed an extended survey to all 1677 participants assessing various psychological and behavioral issues related to genetic screening and testing; 1154 responded (68.8%).
Follow-up 1 year later
One year after the clinical exam, we resurveyed these 1154 respondents and asked additional questions about any problems with employment or insurance (health, life, or disability) in the past year “related to hemochromatosis or iron overload.” Participants who had problems were contacted by telephone for follow-up questions about the nature and circumstances of the problem.
For comparison with clinical exam participants, we surveyed a stratified random sample of 939 screening participants in a similar fashion 1 year following screening. These participants were not eligible for a clinical exam but they had inconclusive screening results, indicating possible elevated risk of hereditary hemochromatosis/iron overload, such as HFE genotypes other than C282Y homozygosity, or lesser elevations of transferrin saturation or serum ferritin.18 Also surveyed at 1 year were 803 controls (469 of whom had a clinical exam and 334 who did not), who were randomly selected following the age distribution of the other participants. All controls had no known HFE genotypes associated with iron overload and had transferrin saturation and serum ferritin values below study-defined thresholds for risk of iron overload.
Results
Overall, 832 clinical exam participants (72.1%) responded among the 1154 who were surveyed 1 year after their exam. Sample characteristics are shown in TABLE 1.
Few discrimination problems were found
Twenty-four (2.8%) reported they had 1 or more problems with employment or insurance that they believed were related to hereditary hemochromatosis/iron overload. Researchers made follow-up phone contact with 17 of these (70.8%), but 7 were lost to follow-up. Only 3 of these 17 participants verified problems that were possibly related to the participation in the HEIRS Study. Among the comparison group respondents (controls and inconclusive screening results), 6 (0.5%) reported a problem with employment or insurance. However, after we made contact with 5 of the 6 respondents, we were unable to verify any of the 5 cases.
All 3 verified reports of problems came from participants who received a clinical exam based on elevated transferrin saturation and serum ferritin levels, rather than based on their HFE genotypes. There were no verified reports from any of the 153 newly identified C282Y homozygotes who responded (out of a total of 252 such participants in the HEIRS Study). Details of the 3 verified problems are shown in TABLE 2.
One person with primary iron overload was denied long-term care insurance. Two people with elevated transferrin saturation and serum ferritin levels of undetermined cause reported having problems with life insurance. One was charged an increased rate, and the second one was initially refused insurance but was later covered after a physician explained that serum iron measures had returned to normal. There were no verified reports of problems with health insurance or employment. (None of the 7 participants who reported problems but who were lost to further follow-up were newly identified C282Y homozygotes, nor did any have C282Y or H63D HFE mutations.)
TABLE 1
Characteristics of all who responded to follow-up
CLINICAL EXAM | COMPARISON GROUPS | |
---|---|---|
Number of follow-up surveys | 1154 | 1742 |
Number (%) of respondents | 832 (72.1) | 1130 (64.9) |
Age: mean (SD) | 56.5 years (13.4) | 53.2 years (13.6) |
Gender: N (%)* | ||
Male | 439 (52.8) | 357 (31.7) |
Female | 393 (47.2) | 768 (68.3) |
Race: N (%) | ||
White | 461 (55.4) | 788 (69.7) |
Other | 371 (44.6) | 342 (30.3) |
Language: N (%)* | ||
English | 728 (87.5) | 1027 (91.4) |
Other | 104 (12.5) | 97 (8.6) |
Insurance coverage: N (%)* | ||
Disability insurance | 240 (31.1) | 391 (37.1) |
Life insurance | 494 (62.2) | 736 (67.8) |
Health insurance | 678 (83.4) | 980 (88.7) |
Employed: N (%)* | 394 (55.7) | 646 (65.5) |
* Not all survey respondents answered these questions. Percent is based on those who answered. |
Discussion
Legal definitions and jurisdictions: Their role in discrimination
In the present study, all 3 participants who reported problems received a clinical examination based on elevated blood iron measures (transferrin saturation and serum ferritin). We verified no problems among participants with any C282Y or H63D HFE genotypes (including both homozygotes or heterozygotes). Therefore, under prevailing definitions, the reported problems do not appear to constitute “genetic discrimination.”15 Furthermore, we received no verified reports of problems with employment or health insurance, for which legal protections are much stronger than for other types of potential discrimination.19
Of note, though: None of our study jurisdictions had legal protections against genetic discrimination by life insurers or long-term-care insurers, and these are the 2 areas where our participants encountered problems. This suggests that existing legal protections may be somewhat effective, although it is also consistent with the argument that such protections address potential problems that are rare or nonexistent.1
Examining the individual case reports (TABLE 2), insurance was denied outright in just one case, involving long-term care insurance, and that participant had health problems unrelated to iron overload that could have contributed to the denial. In the 2 life insurance cases, one person was insured with the help of a physician’s letter, and the other person obtained insurance with an increased premium.
TABLE 2
Characteristics of the 3 participants reporting insurance problems
Race | Caucasian, Asian, Pacific Islander (one each) | ||
Gender | Two males and one female | ||
PARTICIPANT 1 | PARTICIPANT 2 | PARTICIPANT 3 | |
Age | over 64 | 45–64 | 45–64 |
Genotype | normal (wild-type) HFE | normal (wild-type) HFE | normal (wild-type) HFE |
Phenotype | Elevated transferrin saturation (51%) and serum ferritin (917 mcg/L) | Elevated transferrin saturation (53%) serum ferritin (740 mcg/L) | Elevated transferrin saturation (76%) and serum ferritin (2871 mcg/L) |
Other health problems | Obese; spherocytosis; reported history of arrhythmia | Reported history of thalassemia trait | Reports 5 alcohol servings per day; evidence of liver abnormality |
Study classification | Primary iron overload | Cause of iron overload indeterminate | Cause of iron overload indeterminate |
Reported problem | Denied long-term-care insurance by 2 large companies | Obtained life insurance but at an increased rate | Initially denied life insurance, but successfully appealed with a physician’s letter stating no iron overload |
Notes | Self-rated health status of 2 (“fair”) out of 5 (“excellent”) | Participant believes this was not due to participation in HEIRS Study, but was due to iron elevations that were identified by the study and reconfirmed by independent testing done for the insurance company | Reports that iron level returned to normal after ceasing to drink red wine |
Limitations of this study
Because this study had only a 1-year follow-up period, it provides no basis for determining the long-term prevalence of insurance or employment problems. However, it appears that after 1 year, the extent of these problems is very small. No verified problems were reported by newly identified C282Y homozygotes or by participants with any other C282Y or H63D HFE genotypes.
Our findings contrast with the 20% prevalence of discrimination among hemochromatosis patients reported by Shaheen et al.16 Their study, however, evaluated subjects who had been diagnosed in routine medical care to have hemochromatosis an average of 4.5 years before discrimination evaluation, and who were under treatment for iron overload.
Verification contacts in our study were made with those reporting a problem, which may have resulted in some underreporting among respondents. Also, we did not determine which participants sought or changed insurance during the study period, so we do not know the exposure rate to potential discrimination. Nevertheless, these findings provide some empirical basis for informing clinicians, researchers, patients, and Institution Review Boards that the risk of insurance or employment problems following genetic screening for hemochromatosis appears to be quite small.
Funding/Support
This study is supported by contracts N01-HC05185 (University of Minnesota), N01-HC05186 (Howard University), N01-HC05188 (University of Alabama at Birmingham), N01-HC05189 (Kaiser Permanente Center for Health Research), N01-HC05190 (University of California, Irvine), N01-HC05191 (London Health Sciences Centre), and N01-HC05192 (Wake Forest University).
Additional support was provided by the Howard University General Clinical Research Center (GCRC) grant, M01-RR 10284, and the UCSD/UCI Satellite GCRC grant, M01-RR 00827 (University of California, Irvine), sponsored by the National Center for Research Resources, National Institutes of Health. Additional support was provided by the University of Alabama at Birmingham General Clinical Research Center (GCRC) grant M01-RR 00032, Southern Iron Disorders Center, Howard University GCRC grant M01-RR 10284, Howard University Research Scientist Award UH1-HL03679-05 from the National Heart, Lung, and Blood Institute and the Office of Research on Minority Health; and grant UC Irvine M01 RR 000827 from the General Clinical Research Centers Program of the National Center for Research Resources National Institutes of Health. These funding organizations participated in the study’s design and conduct, and they approved publication of this paper, but they did not directly participate in the collection, management, analysis, or interpretation of the data or the preparation of this manuscript.
All authors had full access to all of the data in the study and they take responsibility for the integrity of the data and the accuracy of the data analysis.
The HEIRS Study investigators are listed at www.heirs-study.org/PP_Policy.htm.
CorrespondenceMark A. Hall, JD, Wake Forest University Medical School, Department of Public Health Sciences, 2000 W. 1st Street, Winston-Salem NC 27157-1063; [email protected].
Purpose This study measured the extent of insurance and employment problems associated with population screening for hereditary hemochromatosis and iron overload.
Methods 101,168 primary care patients from the US and Canada were screened for iron phenotypes and HFE genotypes associated with hemochromatosis. Those identified to be at risk (2253) were offered a clinical examination, which 1677 (74%) accepted, and the 1154 of these who responded to an initial questionnaire about psychosocial issues were surveyed 1 year later about whether they had experienced problems with insurance or employment that they attributed to hereditary hemochromatosis and iron overload.
Results 832 (72.1%) of the 1154 participants surveyed after 1 year responded to the second survey. Three (0.4%) had verified problems with insurance or employment that they believed were related to hereditary hemochromatosis and iron overload. Two had problems with life insurance, and one with long-term care insurance. All 3 had elevated iron levels but not a relevant HFE genotype. One of the life insurance problems was resolved; the second one was not serious. The participant who was denied long-term care insurance had other health conditions unrelated to hereditary hemochromatosis and iron overload that could have contributed to the denial. No problems were verified for health insurance or employment, or from any of the comparison group participants (controls and those with inconclusive screening results).
Conclusions The risk of insurance or employment problems 1 year after phenotype and genotype screening for hereditary hemochromatosis and iron overload is very low.
Social risks from genetic testing are a major public policy concern in medical genetics and genetics research.1-3 These concerns are focused mainly on health insurance, as insurers have an incentive to avoid those clients it will be costly for them to insure. This concern also applies to employers, who pay for most private health care in the US.
Since the beginnings of the Human Genome Project in 1990, legislation has been proposed to head off possible genetic discrimination. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibited most insurers from considering genetic risks as preexisting conditions. Since the 1990s, all but 2 states have passed laws that limit genetic discrimination in health insurance; 34 states ban or limit genetic discrimination by employers.4 In addition, a piece of federal legislation is pending. The Genetic Information Nondiscrimination Act, intended to prohibit health insurance and employment discrimination on the basis of genetic information, passed the House in April 2007 but, at press time, had not been voted on by the Senate.
Because state laws usually do not apply to life or disability insurance, and their applicability to employment is inconsistent, the potential for discrimination problems is still of concern to patients with costly conditions that may be uncovered by genetic screening.
Hereditary hemochromatosis—early detection is key
Members of the health care community have expressed concern that genetic discrimination will hamper efforts to detect and mitigate hereditary hemochromatosis, a relatively common condition marked by iron overload, which can lead to irreversible organ damage and related health problems.5-9 Hereditary hemochromatosis is an autosomal recessive condition that typically is associated with 2 copies of the C282Y mutation in the HFE gene on chromosome 6, although the H63D HFE mutation is also associated with hereditary hemochromatosis in some cases.10,11 If detected early, health problems from iron overload can be prevented by periodic phlebotomy. Not surprisingly, then, there is public health interest in the screening and detection of hemochromatosis or iron overload before symptoms arise.9,12-14
There are documented instances, however, of healthy people who experienced discrimination in insurance or employment based on having a phenotype or genotype associated with hereditary hemochromatosis.8,15,16 Alper and colleagues noted that “[i]n a general screening program of 100 million people…even if only 5% of these people [who screen positive for hereditary hemochromatosis] encounter discrimination, this amounts to approximately 28,000 people.”8 Alper’s speculation has not been tested because no large-scale studies of discrimination resulting from screening the general population have been conducted.
This study looks to identify possible social risks from genetic screening by surveying a large and diverse racial/ethnic primary care population participating in a study of iron overload and hereditary hemochromatosis in the US and Canada. We have sought to determine the number and types of problems associated with insurance and employment 1 year after screening and clinical examination for relevant hereditary hemochromatosis phenotypes and genotypes.
Methods
The data for this analysis come from the Hemochromatosis and Iron Overload Screening (HEIRS) Study. A full description of the study’s rationale, design, and methods has been published elsewhere.17
Identifying the subjects
The research team screened a multiracial/ethnic sample of 101,168 primary care patients, 25 years of age and older, over a 2-year period beginning in March 2001. We recruited participants in approximately equal numbers at 5 field centers, 4 in the US and 1 in Canada. We chose study sites and recruitment goals to produce a sample with about 50% non-Caucasians. A central laboratory assayed blood samples for transferrin saturation, serum ferritin, and HFE C282Y and H63D mutations. A comprehensive clinical evaluation was offered to all C282Y homozygotes and to all non-C282Y homozygotes who met study thresholds for elevated transferrin saturation and serum ferritin iron measures.17
We identified a total of 2253 such participants. Of these, 1677 (74%) participated in the clinical exam, which assessed body iron stores and attempted to distinguish between primary and secondary causes of iron overload. Clinical exam results were provided to the participants—and, if they consented, to their primary care providers. We then mailed an extended survey to all 1677 participants assessing various psychological and behavioral issues related to genetic screening and testing; 1154 responded (68.8%).
Follow-up 1 year later
One year after the clinical exam, we resurveyed these 1154 respondents and asked additional questions about any problems with employment or insurance (health, life, or disability) in the past year “related to hemochromatosis or iron overload.” Participants who had problems were contacted by telephone for follow-up questions about the nature and circumstances of the problem.
For comparison with clinical exam participants, we surveyed a stratified random sample of 939 screening participants in a similar fashion 1 year following screening. These participants were not eligible for a clinical exam but they had inconclusive screening results, indicating possible elevated risk of hereditary hemochromatosis/iron overload, such as HFE genotypes other than C282Y homozygosity, or lesser elevations of transferrin saturation or serum ferritin.18 Also surveyed at 1 year were 803 controls (469 of whom had a clinical exam and 334 who did not), who were randomly selected following the age distribution of the other participants. All controls had no known HFE genotypes associated with iron overload and had transferrin saturation and serum ferritin values below study-defined thresholds for risk of iron overload.
Results
Overall, 832 clinical exam participants (72.1%) responded among the 1154 who were surveyed 1 year after their exam. Sample characteristics are shown in TABLE 1.
Few discrimination problems were found
Twenty-four (2.8%) reported they had 1 or more problems with employment or insurance that they believed were related to hereditary hemochromatosis/iron overload. Researchers made follow-up phone contact with 17 of these (70.8%), but 7 were lost to follow-up. Only 3 of these 17 participants verified problems that were possibly related to the participation in the HEIRS Study. Among the comparison group respondents (controls and inconclusive screening results), 6 (0.5%) reported a problem with employment or insurance. However, after we made contact with 5 of the 6 respondents, we were unable to verify any of the 5 cases.
All 3 verified reports of problems came from participants who received a clinical exam based on elevated transferrin saturation and serum ferritin levels, rather than based on their HFE genotypes. There were no verified reports from any of the 153 newly identified C282Y homozygotes who responded (out of a total of 252 such participants in the HEIRS Study). Details of the 3 verified problems are shown in TABLE 2.
One person with primary iron overload was denied long-term care insurance. Two people with elevated transferrin saturation and serum ferritin levels of undetermined cause reported having problems with life insurance. One was charged an increased rate, and the second one was initially refused insurance but was later covered after a physician explained that serum iron measures had returned to normal. There were no verified reports of problems with health insurance or employment. (None of the 7 participants who reported problems but who were lost to further follow-up were newly identified C282Y homozygotes, nor did any have C282Y or H63D HFE mutations.)
TABLE 1
Characteristics of all who responded to follow-up
CLINICAL EXAM | COMPARISON GROUPS | |
---|---|---|
Number of follow-up surveys | 1154 | 1742 |
Number (%) of respondents | 832 (72.1) | 1130 (64.9) |
Age: mean (SD) | 56.5 years (13.4) | 53.2 years (13.6) |
Gender: N (%)* | ||
Male | 439 (52.8) | 357 (31.7) |
Female | 393 (47.2) | 768 (68.3) |
Race: N (%) | ||
White | 461 (55.4) | 788 (69.7) |
Other | 371 (44.6) | 342 (30.3) |
Language: N (%)* | ||
English | 728 (87.5) | 1027 (91.4) |
Other | 104 (12.5) | 97 (8.6) |
Insurance coverage: N (%)* | ||
Disability insurance | 240 (31.1) | 391 (37.1) |
Life insurance | 494 (62.2) | 736 (67.8) |
Health insurance | 678 (83.4) | 980 (88.7) |
Employed: N (%)* | 394 (55.7) | 646 (65.5) |
* Not all survey respondents answered these questions. Percent is based on those who answered. |
Discussion
Legal definitions and jurisdictions: Their role in discrimination
In the present study, all 3 participants who reported problems received a clinical examination based on elevated blood iron measures (transferrin saturation and serum ferritin). We verified no problems among participants with any C282Y or H63D HFE genotypes (including both homozygotes or heterozygotes). Therefore, under prevailing definitions, the reported problems do not appear to constitute “genetic discrimination.”15 Furthermore, we received no verified reports of problems with employment or health insurance, for which legal protections are much stronger than for other types of potential discrimination.19
Of note, though: None of our study jurisdictions had legal protections against genetic discrimination by life insurers or long-term-care insurers, and these are the 2 areas where our participants encountered problems. This suggests that existing legal protections may be somewhat effective, although it is also consistent with the argument that such protections address potential problems that are rare or nonexistent.1
Examining the individual case reports (TABLE 2), insurance was denied outright in just one case, involving long-term care insurance, and that participant had health problems unrelated to iron overload that could have contributed to the denial. In the 2 life insurance cases, one person was insured with the help of a physician’s letter, and the other person obtained insurance with an increased premium.
TABLE 2
Characteristics of the 3 participants reporting insurance problems
Race | Caucasian, Asian, Pacific Islander (one each) | ||
Gender | Two males and one female | ||
PARTICIPANT 1 | PARTICIPANT 2 | PARTICIPANT 3 | |
Age | over 64 | 45–64 | 45–64 |
Genotype | normal (wild-type) HFE | normal (wild-type) HFE | normal (wild-type) HFE |
Phenotype | Elevated transferrin saturation (51%) and serum ferritin (917 mcg/L) | Elevated transferrin saturation (53%) serum ferritin (740 mcg/L) | Elevated transferrin saturation (76%) and serum ferritin (2871 mcg/L) |
Other health problems | Obese; spherocytosis; reported history of arrhythmia | Reported history of thalassemia trait | Reports 5 alcohol servings per day; evidence of liver abnormality |
Study classification | Primary iron overload | Cause of iron overload indeterminate | Cause of iron overload indeterminate |
Reported problem | Denied long-term-care insurance by 2 large companies | Obtained life insurance but at an increased rate | Initially denied life insurance, but successfully appealed with a physician’s letter stating no iron overload |
Notes | Self-rated health status of 2 (“fair”) out of 5 (“excellent”) | Participant believes this was not due to participation in HEIRS Study, but was due to iron elevations that were identified by the study and reconfirmed by independent testing done for the insurance company | Reports that iron level returned to normal after ceasing to drink red wine |
Limitations of this study
Because this study had only a 1-year follow-up period, it provides no basis for determining the long-term prevalence of insurance or employment problems. However, it appears that after 1 year, the extent of these problems is very small. No verified problems were reported by newly identified C282Y homozygotes or by participants with any other C282Y or H63D HFE genotypes.
Our findings contrast with the 20% prevalence of discrimination among hemochromatosis patients reported by Shaheen et al.16 Their study, however, evaluated subjects who had been diagnosed in routine medical care to have hemochromatosis an average of 4.5 years before discrimination evaluation, and who were under treatment for iron overload.
Verification contacts in our study were made with those reporting a problem, which may have resulted in some underreporting among respondents. Also, we did not determine which participants sought or changed insurance during the study period, so we do not know the exposure rate to potential discrimination. Nevertheless, these findings provide some empirical basis for informing clinicians, researchers, patients, and Institution Review Boards that the risk of insurance or employment problems following genetic screening for hemochromatosis appears to be quite small.
Funding/Support
This study is supported by contracts N01-HC05185 (University of Minnesota), N01-HC05186 (Howard University), N01-HC05188 (University of Alabama at Birmingham), N01-HC05189 (Kaiser Permanente Center for Health Research), N01-HC05190 (University of California, Irvine), N01-HC05191 (London Health Sciences Centre), and N01-HC05192 (Wake Forest University).
Additional support was provided by the Howard University General Clinical Research Center (GCRC) grant, M01-RR 10284, and the UCSD/UCI Satellite GCRC grant, M01-RR 00827 (University of California, Irvine), sponsored by the National Center for Research Resources, National Institutes of Health. Additional support was provided by the University of Alabama at Birmingham General Clinical Research Center (GCRC) grant M01-RR 00032, Southern Iron Disorders Center, Howard University GCRC grant M01-RR 10284, Howard University Research Scientist Award UH1-HL03679-05 from the National Heart, Lung, and Blood Institute and the Office of Research on Minority Health; and grant UC Irvine M01 RR 000827 from the General Clinical Research Centers Program of the National Center for Research Resources National Institutes of Health. These funding organizations participated in the study’s design and conduct, and they approved publication of this paper, but they did not directly participate in the collection, management, analysis, or interpretation of the data or the preparation of this manuscript.
All authors had full access to all of the data in the study and they take responsibility for the integrity of the data and the accuracy of the data analysis.
The HEIRS Study investigators are listed at www.heirs-study.org/PP_Policy.htm.
CorrespondenceMark A. Hall, JD, Wake Forest University Medical School, Department of Public Health Sciences, 2000 W. 1st Street, Winston-Salem NC 27157-1063; [email protected].
1. Greely HT. Banning genetic discrimination. N Engl J Med 2005;353:865-867.
2. Hudson KL, Rothenberg KH, Andrews LB, Kahn MJ, Collins FS. Genetic discrimination and health insurance: an urgent need for reform. Science 1995;270:391-393.
3. Billings PR, Kohn MA, de Cuevas M, Beckwith J, Alper JS, Natowicz MR. Discrimination as a consequence of genetic testing. Am J Hum Genetics 1992;50:476-482.
4. National Conference of State Legislatures. Genetics laws and legislative activity. Available at: www.ncsl.org/programs/health/genetics/charts.htm. Accessed on September 14, 2007.
5. Cogswell ME, McDonnell SM, Khoury MJ, Franks AL, Burke W, Brittenham G. Iron overload, public health, and genetics: Evaluating the evidence for hemochromatosis screening. Ann Intern Med 1998;129:971-979.
6. Delatycki MB, Allen KJ, Nisselle AE, et al. Use of community genetic screening to prevent HFE-associated hereditary haemochromatosis. Lancet 2005;366:314-316.
7. Qaseem A, Aronson M, Fitterman N, et al. Screening for hereditary hemochromatosis: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2005;143:517-521.
8. Alper JS, Geller LN, Barash CI, Billings PR, Laden V, Natowicz MR. Genetic discrimination and screening for hemochromatosis. J Pub Health Pol 1994;15:345-358.
9. Burke W, Thomson E, Khoury MJ, McDonnell SM, Press N, Adams PC. Hereditary hemochromatosis: gene discovery and its implications for population-based screening. JAMA 1998;280:172-178.
10. Hanson EH, Imperatore G, Burke W. HFE Gene and Hereditary Hemochromatosis: A HuGE Review. Am J Epidemiol 2001;154:193-206.
11. Adams PC, Walker AP, Acton RT. A primer for predicting risk of disease in HFE-linked hemochromatosis. Genetic Testing 2001;5:311-316.
12. Adams PC. Population screening for hemochromatosis. Gut 2000;46:301-303.
13. Barton JC, Acton RT. Population screening for hemochromatosis: Has the time finally come? Curr Gastroenterol Rep 2000;2:1-9.
14. McDonnell SM, Phatak PD, Felitti V, Hover A, McLaren GD. Screening for hemochromatosis in primary care settings. Ann Intern Med 1998;129:962-970.
15. Barash CI. Genetic discrimination and screening for hemochromatosis: then and now. Genetic Testing 2000;4:213-218.
16. Shaheen NJ, Lawrence LB, Bacon BR, et al. Insurance, employment and psychosocial consequences of a diagnosis of hereditary hemochromatosis in subjects without end organ damage. Am J Gastroenterol 2003;98:1175-1180.
17. McLaren CE, Barton JC, Adams PC, et al. Hemochromatosis and Iron Overload Screening (HEIRS). Study design for an evaluation of 100,000 primary care-based adults. Am J Med Sci 2003;325:53-62.
18. Anderson RT, Wenzel L, Walker AP, et al. Impact of hemochromatosis screening in patients with indeterminate results: the hemochromatosis and iron overload screening study. Genet Med 2006;8:681-687.
19. Hellman D. What makes genetic discrimination exceptional? Am J Law Med 2003;29:77-116.
1. Greely HT. Banning genetic discrimination. N Engl J Med 2005;353:865-867.
2. Hudson KL, Rothenberg KH, Andrews LB, Kahn MJ, Collins FS. Genetic discrimination and health insurance: an urgent need for reform. Science 1995;270:391-393.
3. Billings PR, Kohn MA, de Cuevas M, Beckwith J, Alper JS, Natowicz MR. Discrimination as a consequence of genetic testing. Am J Hum Genetics 1992;50:476-482.
4. National Conference of State Legislatures. Genetics laws and legislative activity. Available at: www.ncsl.org/programs/health/genetics/charts.htm. Accessed on September 14, 2007.
5. Cogswell ME, McDonnell SM, Khoury MJ, Franks AL, Burke W, Brittenham G. Iron overload, public health, and genetics: Evaluating the evidence for hemochromatosis screening. Ann Intern Med 1998;129:971-979.
6. Delatycki MB, Allen KJ, Nisselle AE, et al. Use of community genetic screening to prevent HFE-associated hereditary haemochromatosis. Lancet 2005;366:314-316.
7. Qaseem A, Aronson M, Fitterman N, et al. Screening for hereditary hemochromatosis: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2005;143:517-521.
8. Alper JS, Geller LN, Barash CI, Billings PR, Laden V, Natowicz MR. Genetic discrimination and screening for hemochromatosis. J Pub Health Pol 1994;15:345-358.
9. Burke W, Thomson E, Khoury MJ, McDonnell SM, Press N, Adams PC. Hereditary hemochromatosis: gene discovery and its implications for population-based screening. JAMA 1998;280:172-178.
10. Hanson EH, Imperatore G, Burke W. HFE Gene and Hereditary Hemochromatosis: A HuGE Review. Am J Epidemiol 2001;154:193-206.
11. Adams PC, Walker AP, Acton RT. A primer for predicting risk of disease in HFE-linked hemochromatosis. Genetic Testing 2001;5:311-316.
12. Adams PC. Population screening for hemochromatosis. Gut 2000;46:301-303.
13. Barton JC, Acton RT. Population screening for hemochromatosis: Has the time finally come? Curr Gastroenterol Rep 2000;2:1-9.
14. McDonnell SM, Phatak PD, Felitti V, Hover A, McLaren GD. Screening for hemochromatosis in primary care settings. Ann Intern Med 1998;129:962-970.
15. Barash CI. Genetic discrimination and screening for hemochromatosis: then and now. Genetic Testing 2000;4:213-218.
16. Shaheen NJ, Lawrence LB, Bacon BR, et al. Insurance, employment and psychosocial consequences of a diagnosis of hereditary hemochromatosis in subjects without end organ damage. Am J Gastroenterol 2003;98:1175-1180.
17. McLaren CE, Barton JC, Adams PC, et al. Hemochromatosis and Iron Overload Screening (HEIRS). Study design for an evaluation of 100,000 primary care-based adults. Am J Med Sci 2003;325:53-62.
18. Anderson RT, Wenzel L, Walker AP, et al. Impact of hemochromatosis screening in patients with indeterminate results: the hemochromatosis and iron overload screening study. Genet Med 2006;8:681-687.
19. Hellman D. What makes genetic discrimination exceptional? Am J Law Med 2003;29:77-116.
Flu vaccination rates: How can you do better?
Each year, the flu causes an average of about 36,000 excess deaths and over 200,000 hospitalizations in the US.1,2 Much of this morbidity and mortality is preventable, yet each year, a large proportion of those for whom the vaccine is recommended go unvaccinated (TABLE 1).
TABLE 1
High-risk groups who went unvaccinated with influenza vaccine (2005)
POPULATION GROUP | PROPORTION UNVACCINATED |
---|---|
Household contacts of those at high risk | 83%–91% |
Pregnant women | 84% |
Patients, ages 50–64 years | 77% |
Patients, ages 6–23 months | 67% |
Those with high-risk medical conditions | 66%–82% |
Health care workers | 64% |
Patients, ages ≥65 years | 40% |
Improving rates among health care workers
The recommendations of the Centers for Disease Control and Prevention (CDC) for the 2007–2008 influenza season include a new recommendation that targets health care worker vaccination rates.3 Because of the low rate of vaccination of health care workers, and the potential impact of higher coverage on both worker and patient safety, the CDC now recommends that the level of vaccination coverage be used as one measure of a facility’s patient safety quality program. The CDC also recommends the implementation of policies to encourage acceptance of the vaccine, such as requiring those caregivers who refuse immunization to sign waivers.
Improving rates among patients
To improve vaccination levels among patients, the CDC recommends:
- using reminder/recall systems
- using standing order programs
- administering the vaccine before and during the influenza season to patients during routine health care visits.
For more on improving vaccination coverage, see “Tips to help improve vaccination rates”.
Offer the vaccine to anyone who wants it
While the groups for whom vaccine is recommended are the same as last year (TABLE 2), this year the CDC is emphasizing the importance of:
- offering the vaccine to anyone who wants to reduce their risk of contracting influenza or transmitting the virus to others.
- continuing to offer vaccine to those susceptible throughout the flu season.
A minor change from last year’s recommendations involves children who are 6 months through 8 years of age who receive only 1 dose of vaccine their first year of vaccination. The CDC now recommends that these children receive 2 doses the next year. If they receive only 1 dose 2 years in a row, the CDC recommends only a single dose annually thereafter.
TABLE 2
Who should receive the influenza vaccine?
Anyone who wants to reduce their risk of contracting the flu or transmitting the virus to others People at high risk for complications from the flu, including:
|
The 2 vaccines: How they differ
The same 2 vaccine types are available this year as last: trivalent influenza vaccine (TIV) and live attenuated influenza vaccine (LAIV). The vaccines include the same viral strain antigens and either can be used annually unless contraindicated (TABLE 3).
The major differences between the 2 vaccine types are:
- LAIV is administered as an intranasal spray while TIV requires an intramuscular injection
- LAIV is approved only for healthy people who are 5 to 49 years of age, whereas TIV is approved for anyone over the age of 6 months
- The interval between 2 doses in children under 9 years of age is 4 weeks for TIV and 6 to 10 weeks for LAIV
- LAIV should not be administered to family members or close contacts of those who are immunosuppressed and require a protective environment, while TIV can be used in this situation
- LAIV, being a live virus vaccine, should be administered simultaneously with, or 4 weeks after, the administration of other live virus vaccines. TIV is not a live virus vaccine, and its timing in relation to other live virus vaccines is not an issue.
TABLE 3
Contraindications and precautions for influenza vaccines
TIV trivalent influenza vaccine |
| ||
LAIV live attenuated influenza vaccine |
|
Antiviral options remain the same
Once again this year, the CDC does not recommend the use of adamantane antivirals for prophylaxis or treatment of influenza, leaving the 2 neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza), for these purposes. Treating flu patients with these antivirals shortens the duration of symptoms and may reduce viral shedding.
The earlier the treatment is started, the better the results. There appears to be no—or only minimal—benefit for those with uncomplicated influenza if the treatment is started more than 2 days after the onset of illness.
The Task Force on Community Preventive Services (an independent group, whose members are appointed by the director of the CDC) indicates that there is evidence to support the use of the following methods for improving vaccination rates:4
- Provider reminders, including notations, stickers, or other prompts in clients’ charts that notify staff when a client is due for certain vaccinations, including the influenza vaccine
- A recall system to notify patients when vaccines are due, using telephone messages or mailings. (E-mail messages are not mentioned but should also work)
- Standing orders for adults that allow staff to administer vaccines without the patient seeing the physician
- Assessing provider performance in delivering vaccinations and supplying this data to the provider
- Decreasing out-of-pocket costs for vaccinations.
Consider antiviral prophylaxis for these patients
The CDC recommends that antiviral prophylaxis be considered for those who are susceptible, residing in an area with circulating influenza virus, and who:
- have not been vaccinated or were recently vaccinated (since it takes 2 weeks for immunity to develop after vaccination)
- are unvaccinated and providing care for high-risk individuals
- have a contraindication to the vaccine
- have immune deficiencies and may not respond adequately to the vaccine.
The CDC also recommends prophylaxis for all residents and staff in a long-term care facility where influenza is circulating, without regard to vaccine status. More complete information on indications, dose and duration of antivirals for prophylaxis, and treatment can be found in this year’s CDC recommendations.3
Another flu season approaches
The good news for the coming year is that the government expects that the supply of vaccine will exceed 100 million doses. This should be sufficient, unless unforeseen production problems arise.
Each year millions of doses of influenza vaccine go unused and are discarded. By following the CDC’s recommendations, and those of the Task Force on Community Preventive Services4 (top left), each of us can improve vaccination coverage in our area and minimize the number of hospitalizations and deaths from the flu.
Correspondence
Doug Campos-Outcalt, MD, MPA, 550 e. van buren, Phoenix, AZ 85004; [email protected].
1. Thompson WW, Shay DK, Wintraub E, et al. Mortality associated with influenza and respiratory synctial virus in the United States. JAMA 2003;289:179-186.
2. Thompson WW, Shay DK, Wintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA 2004;292:1333-1340.
3. Centers for Disease Control and Prevention. Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices, 2007. MMWR Recomm Rep 2007;56(RR-6).-
4. Centers for Disease Control and Prevention. Vaccines. Guide to Community Preventive Services Web site. Available at: www.thecommunityguide.org/vaccine. Accessed on September 10, 2007.
Each year, the flu causes an average of about 36,000 excess deaths and over 200,000 hospitalizations in the US.1,2 Much of this morbidity and mortality is preventable, yet each year, a large proportion of those for whom the vaccine is recommended go unvaccinated (TABLE 1).
TABLE 1
High-risk groups who went unvaccinated with influenza vaccine (2005)
POPULATION GROUP | PROPORTION UNVACCINATED |
---|---|
Household contacts of those at high risk | 83%–91% |
Pregnant women | 84% |
Patients, ages 50–64 years | 77% |
Patients, ages 6–23 months | 67% |
Those with high-risk medical conditions | 66%–82% |
Health care workers | 64% |
Patients, ages ≥65 years | 40% |
Improving rates among health care workers
The recommendations of the Centers for Disease Control and Prevention (CDC) for the 2007–2008 influenza season include a new recommendation that targets health care worker vaccination rates.3 Because of the low rate of vaccination of health care workers, and the potential impact of higher coverage on both worker and patient safety, the CDC now recommends that the level of vaccination coverage be used as one measure of a facility’s patient safety quality program. The CDC also recommends the implementation of policies to encourage acceptance of the vaccine, such as requiring those caregivers who refuse immunization to sign waivers.
Improving rates among patients
To improve vaccination levels among patients, the CDC recommends:
- using reminder/recall systems
- using standing order programs
- administering the vaccine before and during the influenza season to patients during routine health care visits.
For more on improving vaccination coverage, see “Tips to help improve vaccination rates”.
Offer the vaccine to anyone who wants it
While the groups for whom vaccine is recommended are the same as last year (TABLE 2), this year the CDC is emphasizing the importance of:
- offering the vaccine to anyone who wants to reduce their risk of contracting influenza or transmitting the virus to others.
- continuing to offer vaccine to those susceptible throughout the flu season.
A minor change from last year’s recommendations involves children who are 6 months through 8 years of age who receive only 1 dose of vaccine their first year of vaccination. The CDC now recommends that these children receive 2 doses the next year. If they receive only 1 dose 2 years in a row, the CDC recommends only a single dose annually thereafter.
TABLE 2
Who should receive the influenza vaccine?
Anyone who wants to reduce their risk of contracting the flu or transmitting the virus to others People at high risk for complications from the flu, including:
|
The 2 vaccines: How they differ
The same 2 vaccine types are available this year as last: trivalent influenza vaccine (TIV) and live attenuated influenza vaccine (LAIV). The vaccines include the same viral strain antigens and either can be used annually unless contraindicated (TABLE 3).
The major differences between the 2 vaccine types are:
- LAIV is administered as an intranasal spray while TIV requires an intramuscular injection
- LAIV is approved only for healthy people who are 5 to 49 years of age, whereas TIV is approved for anyone over the age of 6 months
- The interval between 2 doses in children under 9 years of age is 4 weeks for TIV and 6 to 10 weeks for LAIV
- LAIV should not be administered to family members or close contacts of those who are immunosuppressed and require a protective environment, while TIV can be used in this situation
- LAIV, being a live virus vaccine, should be administered simultaneously with, or 4 weeks after, the administration of other live virus vaccines. TIV is not a live virus vaccine, and its timing in relation to other live virus vaccines is not an issue.
TABLE 3
Contraindications and precautions for influenza vaccines
TIV trivalent influenza vaccine |
| ||
LAIV live attenuated influenza vaccine |
|
Antiviral options remain the same
Once again this year, the CDC does not recommend the use of adamantane antivirals for prophylaxis or treatment of influenza, leaving the 2 neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza), for these purposes. Treating flu patients with these antivirals shortens the duration of symptoms and may reduce viral shedding.
The earlier the treatment is started, the better the results. There appears to be no—or only minimal—benefit for those with uncomplicated influenza if the treatment is started more than 2 days after the onset of illness.
The Task Force on Community Preventive Services (an independent group, whose members are appointed by the director of the CDC) indicates that there is evidence to support the use of the following methods for improving vaccination rates:4
- Provider reminders, including notations, stickers, or other prompts in clients’ charts that notify staff when a client is due for certain vaccinations, including the influenza vaccine
- A recall system to notify patients when vaccines are due, using telephone messages or mailings. (E-mail messages are not mentioned but should also work)
- Standing orders for adults that allow staff to administer vaccines without the patient seeing the physician
- Assessing provider performance in delivering vaccinations and supplying this data to the provider
- Decreasing out-of-pocket costs for vaccinations.
Consider antiviral prophylaxis for these patients
The CDC recommends that antiviral prophylaxis be considered for those who are susceptible, residing in an area with circulating influenza virus, and who:
- have not been vaccinated or were recently vaccinated (since it takes 2 weeks for immunity to develop after vaccination)
- are unvaccinated and providing care for high-risk individuals
- have a contraindication to the vaccine
- have immune deficiencies and may not respond adequately to the vaccine.
The CDC also recommends prophylaxis for all residents and staff in a long-term care facility where influenza is circulating, without regard to vaccine status. More complete information on indications, dose and duration of antivirals for prophylaxis, and treatment can be found in this year’s CDC recommendations.3
Another flu season approaches
The good news for the coming year is that the government expects that the supply of vaccine will exceed 100 million doses. This should be sufficient, unless unforeseen production problems arise.
Each year millions of doses of influenza vaccine go unused and are discarded. By following the CDC’s recommendations, and those of the Task Force on Community Preventive Services4 (top left), each of us can improve vaccination coverage in our area and minimize the number of hospitalizations and deaths from the flu.
Correspondence
Doug Campos-Outcalt, MD, MPA, 550 e. van buren, Phoenix, AZ 85004; [email protected].
Each year, the flu causes an average of about 36,000 excess deaths and over 200,000 hospitalizations in the US.1,2 Much of this morbidity and mortality is preventable, yet each year, a large proportion of those for whom the vaccine is recommended go unvaccinated (TABLE 1).
TABLE 1
High-risk groups who went unvaccinated with influenza vaccine (2005)
POPULATION GROUP | PROPORTION UNVACCINATED |
---|---|
Household contacts of those at high risk | 83%–91% |
Pregnant women | 84% |
Patients, ages 50–64 years | 77% |
Patients, ages 6–23 months | 67% |
Those with high-risk medical conditions | 66%–82% |
Health care workers | 64% |
Patients, ages ≥65 years | 40% |
Improving rates among health care workers
The recommendations of the Centers for Disease Control and Prevention (CDC) for the 2007–2008 influenza season include a new recommendation that targets health care worker vaccination rates.3 Because of the low rate of vaccination of health care workers, and the potential impact of higher coverage on both worker and patient safety, the CDC now recommends that the level of vaccination coverage be used as one measure of a facility’s patient safety quality program. The CDC also recommends the implementation of policies to encourage acceptance of the vaccine, such as requiring those caregivers who refuse immunization to sign waivers.
Improving rates among patients
To improve vaccination levels among patients, the CDC recommends:
- using reminder/recall systems
- using standing order programs
- administering the vaccine before and during the influenza season to patients during routine health care visits.
For more on improving vaccination coverage, see “Tips to help improve vaccination rates”.
Offer the vaccine to anyone who wants it
While the groups for whom vaccine is recommended are the same as last year (TABLE 2), this year the CDC is emphasizing the importance of:
- offering the vaccine to anyone who wants to reduce their risk of contracting influenza or transmitting the virus to others.
- continuing to offer vaccine to those susceptible throughout the flu season.
A minor change from last year’s recommendations involves children who are 6 months through 8 years of age who receive only 1 dose of vaccine their first year of vaccination. The CDC now recommends that these children receive 2 doses the next year. If they receive only 1 dose 2 years in a row, the CDC recommends only a single dose annually thereafter.
TABLE 2
Who should receive the influenza vaccine?
Anyone who wants to reduce their risk of contracting the flu or transmitting the virus to others People at high risk for complications from the flu, including:
|
The 2 vaccines: How they differ
The same 2 vaccine types are available this year as last: trivalent influenza vaccine (TIV) and live attenuated influenza vaccine (LAIV). The vaccines include the same viral strain antigens and either can be used annually unless contraindicated (TABLE 3).
The major differences between the 2 vaccine types are:
- LAIV is administered as an intranasal spray while TIV requires an intramuscular injection
- LAIV is approved only for healthy people who are 5 to 49 years of age, whereas TIV is approved for anyone over the age of 6 months
- The interval between 2 doses in children under 9 years of age is 4 weeks for TIV and 6 to 10 weeks for LAIV
- LAIV should not be administered to family members or close contacts of those who are immunosuppressed and require a protective environment, while TIV can be used in this situation
- LAIV, being a live virus vaccine, should be administered simultaneously with, or 4 weeks after, the administration of other live virus vaccines. TIV is not a live virus vaccine, and its timing in relation to other live virus vaccines is not an issue.
TABLE 3
Contraindications and precautions for influenza vaccines
TIV trivalent influenza vaccine |
| ||
LAIV live attenuated influenza vaccine |
|
Antiviral options remain the same
Once again this year, the CDC does not recommend the use of adamantane antivirals for prophylaxis or treatment of influenza, leaving the 2 neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza), for these purposes. Treating flu patients with these antivirals shortens the duration of symptoms and may reduce viral shedding.
The earlier the treatment is started, the better the results. There appears to be no—or only minimal—benefit for those with uncomplicated influenza if the treatment is started more than 2 days after the onset of illness.
The Task Force on Community Preventive Services (an independent group, whose members are appointed by the director of the CDC) indicates that there is evidence to support the use of the following methods for improving vaccination rates:4
- Provider reminders, including notations, stickers, or other prompts in clients’ charts that notify staff when a client is due for certain vaccinations, including the influenza vaccine
- A recall system to notify patients when vaccines are due, using telephone messages or mailings. (E-mail messages are not mentioned but should also work)
- Standing orders for adults that allow staff to administer vaccines without the patient seeing the physician
- Assessing provider performance in delivering vaccinations and supplying this data to the provider
- Decreasing out-of-pocket costs for vaccinations.
Consider antiviral prophylaxis for these patients
The CDC recommends that antiviral prophylaxis be considered for those who are susceptible, residing in an area with circulating influenza virus, and who:
- have not been vaccinated or were recently vaccinated (since it takes 2 weeks for immunity to develop after vaccination)
- are unvaccinated and providing care for high-risk individuals
- have a contraindication to the vaccine
- have immune deficiencies and may not respond adequately to the vaccine.
The CDC also recommends prophylaxis for all residents and staff in a long-term care facility where influenza is circulating, without regard to vaccine status. More complete information on indications, dose and duration of antivirals for prophylaxis, and treatment can be found in this year’s CDC recommendations.3
Another flu season approaches
The good news for the coming year is that the government expects that the supply of vaccine will exceed 100 million doses. This should be sufficient, unless unforeseen production problems arise.
Each year millions of doses of influenza vaccine go unused and are discarded. By following the CDC’s recommendations, and those of the Task Force on Community Preventive Services4 (top left), each of us can improve vaccination coverage in our area and minimize the number of hospitalizations and deaths from the flu.
Correspondence
Doug Campos-Outcalt, MD, MPA, 550 e. van buren, Phoenix, AZ 85004; [email protected].
1. Thompson WW, Shay DK, Wintraub E, et al. Mortality associated with influenza and respiratory synctial virus in the United States. JAMA 2003;289:179-186.
2. Thompson WW, Shay DK, Wintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA 2004;292:1333-1340.
3. Centers for Disease Control and Prevention. Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices, 2007. MMWR Recomm Rep 2007;56(RR-6).-
4. Centers for Disease Control and Prevention. Vaccines. Guide to Community Preventive Services Web site. Available at: www.thecommunityguide.org/vaccine. Accessed on September 10, 2007.
1. Thompson WW, Shay DK, Wintraub E, et al. Mortality associated with influenza and respiratory synctial virus in the United States. JAMA 2003;289:179-186.
2. Thompson WW, Shay DK, Wintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA 2004;292:1333-1340.
3. Centers for Disease Control and Prevention. Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices, 2007. MMWR Recomm Rep 2007;56(RR-6).-
4. Centers for Disease Control and Prevention. Vaccines. Guide to Community Preventive Services Web site. Available at: www.thecommunityguide.org/vaccine. Accessed on September 10, 2007.
Eltrombopag increases platelet levels in chronic ITP

GENEVA—A recent trial shows that eltrombopag can, with minimal toxicity, improve platelet levels and reduce bleeding in patients with chronic idiopathic thrombocytopenic purpura (ITP).
The phase 3, randomized, controlled trial evaluated the safety and efficacy of eltrombopag treatment in patients with chronic idiopathic thrombocytopenic purpura (ITP).
James B. Bussel, MD, from Weill Medical College of Cornell University in New York, presented the results at the recent meeting of the International Society on Thrombosis and Haemostasis.
A phase 1 study, reported in a 2007 issue of Blood, administered eltrombopag in active doses of 30, 50, and 75 mg. In normal volunteers, it takes a week for platelet counts to increase. Although increases were seen at all 3 dose levels, the optimal dose of 50 mg was chosen for subsequent studies.
In the phase 3 study, patients were randomized to receive placebo (n=38) or 50 mg of eltrombopag (n=76) once daily for 6 weeks (dose increase to 75 mg allowed). Investigators assessed bleeding according to the World Health Organization bleeding scale.
At the end of treatment (day 43), there was a significant increase in platelet levels in the eltrombopag arm vs the placebo arm. The median platelet count at the end of study was 18,000/μL in the placebo arm and 69,000/μL in the eltrombopag arm. The endpoint of >50,000 platelets/μL was reached in up to 42 days of dosing.
Eighteen out of 76 patients achieved platelet increases to >200,000/μL. The platelet counts fell 2 weeks after the end of therapy. There was a reduction in grade 2/4 bleeding of 18% in the placebo arm, and there were no specific findings of adverse events.
Platelet antibodies are still present as platelet levels fall after the cessation of therapy. Dr Bussel said this study confirmed previous findings with eltrombopag. Treatment not only increased platelet levels, but was able to reduce bleeding.
ITP results in reduced production of marrow platelets and platelet destruction by antibodies. Treatment of ITP is necessary to avoid major bleeding by increasing platelets to >50,000/μL. Eltrombopag is a small molecule, can be used orally, binds to a different region of receptor than thrombopoietin, and signals through the JAK/STAT pathway.

GENEVA—A recent trial shows that eltrombopag can, with minimal toxicity, improve platelet levels and reduce bleeding in patients with chronic idiopathic thrombocytopenic purpura (ITP).
The phase 3, randomized, controlled trial evaluated the safety and efficacy of eltrombopag treatment in patients with chronic idiopathic thrombocytopenic purpura (ITP).
James B. Bussel, MD, from Weill Medical College of Cornell University in New York, presented the results at the recent meeting of the International Society on Thrombosis and Haemostasis.
A phase 1 study, reported in a 2007 issue of Blood, administered eltrombopag in active doses of 30, 50, and 75 mg. In normal volunteers, it takes a week for platelet counts to increase. Although increases were seen at all 3 dose levels, the optimal dose of 50 mg was chosen for subsequent studies.
In the phase 3 study, patients were randomized to receive placebo (n=38) or 50 mg of eltrombopag (n=76) once daily for 6 weeks (dose increase to 75 mg allowed). Investigators assessed bleeding according to the World Health Organization bleeding scale.
At the end of treatment (day 43), there was a significant increase in platelet levels in the eltrombopag arm vs the placebo arm. The median platelet count at the end of study was 18,000/μL in the placebo arm and 69,000/μL in the eltrombopag arm. The endpoint of >50,000 platelets/μL was reached in up to 42 days of dosing.
Eighteen out of 76 patients achieved platelet increases to >200,000/μL. The platelet counts fell 2 weeks after the end of therapy. There was a reduction in grade 2/4 bleeding of 18% in the placebo arm, and there were no specific findings of adverse events.
Platelet antibodies are still present as platelet levels fall after the cessation of therapy. Dr Bussel said this study confirmed previous findings with eltrombopag. Treatment not only increased platelet levels, but was able to reduce bleeding.
ITP results in reduced production of marrow platelets and platelet destruction by antibodies. Treatment of ITP is necessary to avoid major bleeding by increasing platelets to >50,000/μL. Eltrombopag is a small molecule, can be used orally, binds to a different region of receptor than thrombopoietin, and signals through the JAK/STAT pathway.

GENEVA—A recent trial shows that eltrombopag can, with minimal toxicity, improve platelet levels and reduce bleeding in patients with chronic idiopathic thrombocytopenic purpura (ITP).
The phase 3, randomized, controlled trial evaluated the safety and efficacy of eltrombopag treatment in patients with chronic idiopathic thrombocytopenic purpura (ITP).
James B. Bussel, MD, from Weill Medical College of Cornell University in New York, presented the results at the recent meeting of the International Society on Thrombosis and Haemostasis.
A phase 1 study, reported in a 2007 issue of Blood, administered eltrombopag in active doses of 30, 50, and 75 mg. In normal volunteers, it takes a week for platelet counts to increase. Although increases were seen at all 3 dose levels, the optimal dose of 50 mg was chosen for subsequent studies.
In the phase 3 study, patients were randomized to receive placebo (n=38) or 50 mg of eltrombopag (n=76) once daily for 6 weeks (dose increase to 75 mg allowed). Investigators assessed bleeding according to the World Health Organization bleeding scale.
At the end of treatment (day 43), there was a significant increase in platelet levels in the eltrombopag arm vs the placebo arm. The median platelet count at the end of study was 18,000/μL in the placebo arm and 69,000/μL in the eltrombopag arm. The endpoint of >50,000 platelets/μL was reached in up to 42 days of dosing.
Eighteen out of 76 patients achieved platelet increases to >200,000/μL. The platelet counts fell 2 weeks after the end of therapy. There was a reduction in grade 2/4 bleeding of 18% in the placebo arm, and there were no specific findings of adverse events.
Platelet antibodies are still present as platelet levels fall after the cessation of therapy. Dr Bussel said this study confirmed previous findings with eltrombopag. Treatment not only increased platelet levels, but was able to reduce bleeding.
ITP results in reduced production of marrow platelets and platelet destruction by antibodies. Treatment of ITP is necessary to avoid major bleeding by increasing platelets to >50,000/μL. Eltrombopag is a small molecule, can be used orally, binds to a different region of receptor than thrombopoietin, and signals through the JAK/STAT pathway.
Curbside Consequences
Question: I’m a hospitalist in a small hospitalist group, so I stay pretty busy and sometimes I have to turn away a lot of requests for help. Recently I did a curbside consult on a surgical patient with diabetes. It was a hectic day, as usual, but I made time to do it because, to be honest, I’m very interested in these kinds of cases (for personal reasons). Problem is, another physician saw me give the consult and then asked me to do one for him about an hour later ... and I said no! I felt bad, but honestly, I had several patients to follow up with and felt I had to press on. I feel like I might have damaged my relationship with this doctor (a cardiologist). How can I help rebuild our relationship?
Boo-Boo in Beloit, Wis.
Dr. Hospitalist responds: Dear Boo Boo: Feel like you worked your way into a pile of doo doo? I generally go by the rule that if I feel something went wrong with an interaction, something probably did and damage control is in order.
Ignoring the encounter may lead the cardiologist to believe that you don’t value your relationship. I suggest you explain your predicament to the cardiologist and let him/her know that you are addressing problems with your schedule. To fix this “problem,” you need to examine why it occurred and understand how you can prevent it.
If you feel like you are “turn(ing) away a lot of requests for help,” I suspect you are missing a significant amount of business. You can view this as a problem or view this as an opportunity. Also recognize this is an opportunity for competitors. Referring physicians will send referrals elsewhere if you are not able to consistently provide the necessary service.
What’s not clear to me is whether your inability to accommodate requests for referrals is due to inadequate staffing, inefficiency, inappropriate billing, or a combination of factors.
To elucidate this situation, you need data. You will never know the facts until you gather the data.
If you are not measuring your program’s performance presently, it is never too late to start. Begin by tracking your work relative value units (wRVUs). This is a commonly used marker of productivity. SHM’s biannual productivity and compensation survey benchmarks this data. Are your wRVU data comparable with hospitalists with similar job descriptions? If so, consider adding staff to your program. If your wRVU data fall short of expectations, does the problem lie in billing? Are you billing for each encounter? Are you billing at appropriate levels for service provided? An audit of your notes and bills can be insightful. Or is inefficiency contributing to your problem? If so, consider an examination of your workflow. A workflow redesign with implementation of tools like templates may markedly improve your efficiency.
Career, Committee Work
Question: My career growth is very important to me. I’m presently the only hospitalist in our program, which I started about a year ago. I have many requests to serve on hospital committees. I’ve tried to serve on as many as possible but feel overstretched. Should I stop serving on committees and concentrate on my clinical work? Would this be bad for my career?
Too Busy in Ohio
Dr. Hospitalist responds: Dear Too Busy: Kudos for taking your job seriously, but don’t feel like you have to serve on all committees. Your concern about burnout is legitimate. There are many reasons hospitalists serve on hospital committees.
Seats at the table of some committees clearly have a higher potential impact than other committees. Participation in some committees can foster relationships with other hospital leaders and better position you and your hospitalist program. Others serve because committee participation may be tied to financial remuneration. I suggest you serve on committees where you believe you can be of most benefit to the hospital and for your program.
Ask yourself, “Does the committee work fit with the goals of the hospital or hospitalist program?” I always remind folks that they should not just think of committees as a way to get paid or better themselves. Some of the most meaningful work comes from serving on committees where members make difficult decisions and often sacrifice their individual goals for the betterment of patients and families. Consider limiting your participation to certain committees. Pick wisely, and you may find that you will cherish your participation.
An Unfortunate Encounter
Question: About a week ago, I was rounding with our CEO and a visiting doctor who is a friend of his. The CEO likes to tag along every so often to stay in touch with ‘‘the trenches.” At one point, they witnessed as I conducted a hand-off. I keep apprised of my peers’ discussions on how to do a proper hand-off, so I was following what I think is a pretty sound checklist of steps.
Unbelievably, my CEO’s doctor pal began ‘‘whispering’’ comments to the CEO about how he thought such and such I was doing wasn’t entirely necessary. (I could hear them clearly, as could the physician to whom I was handing off the patient, and the patient herself!)
I happen to know for a fact that the CEO has mused aloud and behind closed doors about the value of our hospital group. I’ve heard him, and friends have told me they have, too. I feel as though he’s undermining our efforts to adhere to a sound hand-off routine. How can I try to make him understand the value of a sound hand-off plan? Even if I can’t, how can I get my peers to buy in to better hand-off rules?
Angry in Helena, Mont.
Dr. Hospitalist responds: Dear Angry: it is laudable that your CEO makes hospital rounds. More CEOs and hospital administrators should do the same. Whether they are to “keep in touch” or for the appearance of doing so is probably less important. Inevitably they will see things on rounds that will help them understand the challenges doctors and nurses face every day in the hospital.
I share your concern that a colleague—but more importantly, a patient—heard your CEO’s friend make derogatory comments about your work. Although your CEO has made public comments previously about the value of your hospitalist program, he missed the boat on this one. He had a great chance to show you, your colleagues, and your patient how much he values the care you and your colleagues provide.
It may very well be that your CEO did not feel like his relationship with his friend could stand the conflict, but I am concerned that his lack of action may have created irreparable damage to his reputation as a leader. I have seen interactions like this breed gossip, which spreads like wildfire. Soon thereafter, discussions of the situation may bear little resemblance to what actually happened.
Make an appointment to meet with your CEO and describe to him what you saw, heard, and felt. Any smart CEO will understand that aside from an explanation, an apology is in order—if not to appease you, then to save his reputation as a leader. TH
Question: I’m a hospitalist in a small hospitalist group, so I stay pretty busy and sometimes I have to turn away a lot of requests for help. Recently I did a curbside consult on a surgical patient with diabetes. It was a hectic day, as usual, but I made time to do it because, to be honest, I’m very interested in these kinds of cases (for personal reasons). Problem is, another physician saw me give the consult and then asked me to do one for him about an hour later ... and I said no! I felt bad, but honestly, I had several patients to follow up with and felt I had to press on. I feel like I might have damaged my relationship with this doctor (a cardiologist). How can I help rebuild our relationship?
Boo-Boo in Beloit, Wis.
Dr. Hospitalist responds: Dear Boo Boo: Feel like you worked your way into a pile of doo doo? I generally go by the rule that if I feel something went wrong with an interaction, something probably did and damage control is in order.
Ignoring the encounter may lead the cardiologist to believe that you don’t value your relationship. I suggest you explain your predicament to the cardiologist and let him/her know that you are addressing problems with your schedule. To fix this “problem,” you need to examine why it occurred and understand how you can prevent it.
If you feel like you are “turn(ing) away a lot of requests for help,” I suspect you are missing a significant amount of business. You can view this as a problem or view this as an opportunity. Also recognize this is an opportunity for competitors. Referring physicians will send referrals elsewhere if you are not able to consistently provide the necessary service.
What’s not clear to me is whether your inability to accommodate requests for referrals is due to inadequate staffing, inefficiency, inappropriate billing, or a combination of factors.
To elucidate this situation, you need data. You will never know the facts until you gather the data.
If you are not measuring your program’s performance presently, it is never too late to start. Begin by tracking your work relative value units (wRVUs). This is a commonly used marker of productivity. SHM’s biannual productivity and compensation survey benchmarks this data. Are your wRVU data comparable with hospitalists with similar job descriptions? If so, consider adding staff to your program. If your wRVU data fall short of expectations, does the problem lie in billing? Are you billing for each encounter? Are you billing at appropriate levels for service provided? An audit of your notes and bills can be insightful. Or is inefficiency contributing to your problem? If so, consider an examination of your workflow. A workflow redesign with implementation of tools like templates may markedly improve your efficiency.
Career, Committee Work
Question: My career growth is very important to me. I’m presently the only hospitalist in our program, which I started about a year ago. I have many requests to serve on hospital committees. I’ve tried to serve on as many as possible but feel overstretched. Should I stop serving on committees and concentrate on my clinical work? Would this be bad for my career?
Too Busy in Ohio
Dr. Hospitalist responds: Dear Too Busy: Kudos for taking your job seriously, but don’t feel like you have to serve on all committees. Your concern about burnout is legitimate. There are many reasons hospitalists serve on hospital committees.
Seats at the table of some committees clearly have a higher potential impact than other committees. Participation in some committees can foster relationships with other hospital leaders and better position you and your hospitalist program. Others serve because committee participation may be tied to financial remuneration. I suggest you serve on committees where you believe you can be of most benefit to the hospital and for your program.
Ask yourself, “Does the committee work fit with the goals of the hospital or hospitalist program?” I always remind folks that they should not just think of committees as a way to get paid or better themselves. Some of the most meaningful work comes from serving on committees where members make difficult decisions and often sacrifice their individual goals for the betterment of patients and families. Consider limiting your participation to certain committees. Pick wisely, and you may find that you will cherish your participation.
An Unfortunate Encounter
Question: About a week ago, I was rounding with our CEO and a visiting doctor who is a friend of his. The CEO likes to tag along every so often to stay in touch with ‘‘the trenches.” At one point, they witnessed as I conducted a hand-off. I keep apprised of my peers’ discussions on how to do a proper hand-off, so I was following what I think is a pretty sound checklist of steps.
Unbelievably, my CEO’s doctor pal began ‘‘whispering’’ comments to the CEO about how he thought such and such I was doing wasn’t entirely necessary. (I could hear them clearly, as could the physician to whom I was handing off the patient, and the patient herself!)
I happen to know for a fact that the CEO has mused aloud and behind closed doors about the value of our hospital group. I’ve heard him, and friends have told me they have, too. I feel as though he’s undermining our efforts to adhere to a sound hand-off routine. How can I try to make him understand the value of a sound hand-off plan? Even if I can’t, how can I get my peers to buy in to better hand-off rules?
Angry in Helena, Mont.
Dr. Hospitalist responds: Dear Angry: it is laudable that your CEO makes hospital rounds. More CEOs and hospital administrators should do the same. Whether they are to “keep in touch” or for the appearance of doing so is probably less important. Inevitably they will see things on rounds that will help them understand the challenges doctors and nurses face every day in the hospital.
I share your concern that a colleague—but more importantly, a patient—heard your CEO’s friend make derogatory comments about your work. Although your CEO has made public comments previously about the value of your hospitalist program, he missed the boat on this one. He had a great chance to show you, your colleagues, and your patient how much he values the care you and your colleagues provide.
It may very well be that your CEO did not feel like his relationship with his friend could stand the conflict, but I am concerned that his lack of action may have created irreparable damage to his reputation as a leader. I have seen interactions like this breed gossip, which spreads like wildfire. Soon thereafter, discussions of the situation may bear little resemblance to what actually happened.
Make an appointment to meet with your CEO and describe to him what you saw, heard, and felt. Any smart CEO will understand that aside from an explanation, an apology is in order—if not to appease you, then to save his reputation as a leader. TH
Question: I’m a hospitalist in a small hospitalist group, so I stay pretty busy and sometimes I have to turn away a lot of requests for help. Recently I did a curbside consult on a surgical patient with diabetes. It was a hectic day, as usual, but I made time to do it because, to be honest, I’m very interested in these kinds of cases (for personal reasons). Problem is, another physician saw me give the consult and then asked me to do one for him about an hour later ... and I said no! I felt bad, but honestly, I had several patients to follow up with and felt I had to press on. I feel like I might have damaged my relationship with this doctor (a cardiologist). How can I help rebuild our relationship?
Boo-Boo in Beloit, Wis.
Dr. Hospitalist responds: Dear Boo Boo: Feel like you worked your way into a pile of doo doo? I generally go by the rule that if I feel something went wrong with an interaction, something probably did and damage control is in order.
Ignoring the encounter may lead the cardiologist to believe that you don’t value your relationship. I suggest you explain your predicament to the cardiologist and let him/her know that you are addressing problems with your schedule. To fix this “problem,” you need to examine why it occurred and understand how you can prevent it.
If you feel like you are “turn(ing) away a lot of requests for help,” I suspect you are missing a significant amount of business. You can view this as a problem or view this as an opportunity. Also recognize this is an opportunity for competitors. Referring physicians will send referrals elsewhere if you are not able to consistently provide the necessary service.
What’s not clear to me is whether your inability to accommodate requests for referrals is due to inadequate staffing, inefficiency, inappropriate billing, or a combination of factors.
To elucidate this situation, you need data. You will never know the facts until you gather the data.
If you are not measuring your program’s performance presently, it is never too late to start. Begin by tracking your work relative value units (wRVUs). This is a commonly used marker of productivity. SHM’s biannual productivity and compensation survey benchmarks this data. Are your wRVU data comparable with hospitalists with similar job descriptions? If so, consider adding staff to your program. If your wRVU data fall short of expectations, does the problem lie in billing? Are you billing for each encounter? Are you billing at appropriate levels for service provided? An audit of your notes and bills can be insightful. Or is inefficiency contributing to your problem? If so, consider an examination of your workflow. A workflow redesign with implementation of tools like templates may markedly improve your efficiency.
Career, Committee Work
Question: My career growth is very important to me. I’m presently the only hospitalist in our program, which I started about a year ago. I have many requests to serve on hospital committees. I’ve tried to serve on as many as possible but feel overstretched. Should I stop serving on committees and concentrate on my clinical work? Would this be bad for my career?
Too Busy in Ohio
Dr. Hospitalist responds: Dear Too Busy: Kudos for taking your job seriously, but don’t feel like you have to serve on all committees. Your concern about burnout is legitimate. There are many reasons hospitalists serve on hospital committees.
Seats at the table of some committees clearly have a higher potential impact than other committees. Participation in some committees can foster relationships with other hospital leaders and better position you and your hospitalist program. Others serve because committee participation may be tied to financial remuneration. I suggest you serve on committees where you believe you can be of most benefit to the hospital and for your program.
Ask yourself, “Does the committee work fit with the goals of the hospital or hospitalist program?” I always remind folks that they should not just think of committees as a way to get paid or better themselves. Some of the most meaningful work comes from serving on committees where members make difficult decisions and often sacrifice their individual goals for the betterment of patients and families. Consider limiting your participation to certain committees. Pick wisely, and you may find that you will cherish your participation.
An Unfortunate Encounter
Question: About a week ago, I was rounding with our CEO and a visiting doctor who is a friend of his. The CEO likes to tag along every so often to stay in touch with ‘‘the trenches.” At one point, they witnessed as I conducted a hand-off. I keep apprised of my peers’ discussions on how to do a proper hand-off, so I was following what I think is a pretty sound checklist of steps.
Unbelievably, my CEO’s doctor pal began ‘‘whispering’’ comments to the CEO about how he thought such and such I was doing wasn’t entirely necessary. (I could hear them clearly, as could the physician to whom I was handing off the patient, and the patient herself!)
I happen to know for a fact that the CEO has mused aloud and behind closed doors about the value of our hospital group. I’ve heard him, and friends have told me they have, too. I feel as though he’s undermining our efforts to adhere to a sound hand-off routine. How can I try to make him understand the value of a sound hand-off plan? Even if I can’t, how can I get my peers to buy in to better hand-off rules?
Angry in Helena, Mont.
Dr. Hospitalist responds: Dear Angry: it is laudable that your CEO makes hospital rounds. More CEOs and hospital administrators should do the same. Whether they are to “keep in touch” or for the appearance of doing so is probably less important. Inevitably they will see things on rounds that will help them understand the challenges doctors and nurses face every day in the hospital.
I share your concern that a colleague—but more importantly, a patient—heard your CEO’s friend make derogatory comments about your work. Although your CEO has made public comments previously about the value of your hospitalist program, he missed the boat on this one. He had a great chance to show you, your colleagues, and your patient how much he values the care you and your colleagues provide.
It may very well be that your CEO did not feel like his relationship with his friend could stand the conflict, but I am concerned that his lack of action may have created irreparable damage to his reputation as a leader. I have seen interactions like this breed gossip, which spreads like wildfire. Soon thereafter, discussions of the situation may bear little resemblance to what actually happened.
Make an appointment to meet with your CEO and describe to him what you saw, heard, and felt. Any smart CEO will understand that aside from an explanation, an apology is in order—if not to appease you, then to save his reputation as a leader. TH
A Unit-Based Approach
Would you want all your patients on the same nursing unit? Think about it—no more walking all over the building to see a few patients on each floor.
Because you would be physically present on “your” unit nearly all day, you could develop close working relationships with the nurses and other caregivers, which might improve everyone’s satisfaction with work. Everyone could better anticipate your work flow and communicate this to patients and families. You likely would be paged much less often because the nursing staff could keep track of whether you’re with a patient or off the floor to attend a conference; they could hold non-urgent issues until you get back.
All these things might make you and others more efficient—able to see the same number of patients you see today in less time, while maintaining or improving quality and cost effectiveness.
Sound familiar? The idea that working at only one site leads to efficiency and quality improvement is one of the underpinnings of the hospitalist concept. Instead of covering the outpatient office and hospital every day, doctors can focus on only the hospital or only the office. But what if you extended that idea to focusing your practice on only one unit within the hospital rather than the whole building? Would that be a good idea and lead to the benefits described above, or would that be taking the idea of “focused practice” too far?
Before answering, I should describe the approaches some practices have taken to pursue the benefits of concentrating patients in one part of the hospital. I’ll refer to this idea as “unit-based hospitalists,” the term current SHM President Rusty Holman uses when talking about this idea.
Locate most hospitalist patients in one unit. This is the most common form of unit-based hospitalists. Most institutions find the closest they can get to unit-based hospitalists is to have all hospitalist admissions go to the same floor when that floor has a bed available and the patient doesn’t require placement elsewhere. In such cases, the hospitalist practice might have something like 50% of patients on that floor and 50% dispersed throughout the hospital (telemetry, ICU, surgery floor). So the whole hospitalist practice has a primary “home” within the hospital, while each hospitalist spends part of each day caring for patients elsewhere. This is not very difficult for most hospitals to implement—and many are because most hospitalist patients end up on the “general medical” floor. This lets the hospitalist spend more time on that unit than any other. She can get to know the staff on that floor better, which might lead to many benefits, including improved satisfaction and efficiency.
Locate individual hospitalists on different hospital units. A more pure, but uncommon, form of unit-based hospitalists involves changing the way hospitalists are placed through the institution rather than changing patient placement. Each hospitalist in the group is assigned to a different nursing unit—or perhaps more than one unit—and sees whichever hospitalist patients are placed there. This system has the advantage of the hospitalist working all or most of the day on the same nursing unit, which can foster excellent teamwork. Instead of the nurse having to figure out which hospitalist to page for a particular patient, he simply needs to know, “Who is our hospitalist today?” and can contact that doctor for issues on most patients. Additionally, because the hospitalist will spend nearly the whole day physically on that unit, paging can be reduced significantly.
Despite its advantages, basing an individual hospitalist on a particular unit of the hospital is uncommon because in its purest form it can lead to terrible hospitalist-patient continuity. And, it’s hard to be confident that the disruptions in continuity are worth the benefits of the unit-based system. For example, the practice may have a patient to admit in the ED but can’t know which hospitalist should see the patient until a room is assigned. The fifth-floor hospitalist might go admit the patient in the ED, only to have the patient end up on the third floor, in which case the third-floor hospitalist would take over the next day. And each time the patient transferred to a new unit, either because of medical needs such as telemetry or simply because the hospital is full and needs to move patients, he would get a new hospitalist.
In addition to problems with continuity for patients who occupy more than one unit during their stay, this system would mean individual hospitalist workloads might get far out of balance. One floor might be very busy, while another is slow or limited by nurse staff shortages, and the respective hospitalists would have a correspondingly out-of-balance workload. A group could decide to address these problems by, for example, having the fifth-floor hospitalist see patients in other parts of the hospital in an effort to provide better hospitalist-patient continuity and address out-of-balance patient loads. But if this happens with any regularity it would mean the group has essentially moved back to a non-unit-based system.
In nearly all hospitals it would be unnecessary and unreasonable to assign a hospitalist to each nursing unit because some units tend to have few hospitalist patients. Yet when patients end up in those units because of medical necessity or bed space needs, one of the hospitalists will have to leave his/her unit to see this patient. If this happens often enough, it begins to dilute or negate the benefit of basing a hospitalist in one or two units.
Although one of the potential benefits of the unit-based model is enhanced relationships and integration among hospitalists and other unit-based clinical staff, it would be difficult to ensure that the same one or two hospitalists always work in a particular unit, and would limit scheduling flexibility dramatically. For example, if Dr. Starsky and Dr. Hutch are the unit-based hospitalists for Unit A, what happens if Dr. Starsky and Dr. Hutch are both scheduled to be off for the same block of days? What happens if both are scheduled to work the same block of days? To obtain the benefits of enhanced relationships and better unit integration, the practice would need to ensure that this scheduling overlap rarely happens—and that’s hard to do.
Where is the sweet spot in grouping patients and hospitalists by nursing unit? There is a wide range of opinion about whether unit-based hospital medicine in any form is worth pursuing. Some hospitalists are convinced that grouping all of their patients on the same unit could decrease efficiency because the doctor is nearly always working within view of patients and families and may be regularly interrupted. I am convinced that assigning each hospitalist to a particular unit in the hospital yields the greatest benefits. But I also think most institutions will find that the complexity and costs of this system are simply too high to justify. In that case, the next best approach might be to locate most hospitalist patients on the same unit unless that unit is full or the patient must be placed elsewhere. There is a good chance this is happening in your hospital—even if it isn’t written in the policy manual. TH
Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson/Flores Associates, a national hospitalist practice management-consulting firm. This column represents his views and is not intended to reflect an official position of SHM.
Would you want all your patients on the same nursing unit? Think about it—no more walking all over the building to see a few patients on each floor.
Because you would be physically present on “your” unit nearly all day, you could develop close working relationships with the nurses and other caregivers, which might improve everyone’s satisfaction with work. Everyone could better anticipate your work flow and communicate this to patients and families. You likely would be paged much less often because the nursing staff could keep track of whether you’re with a patient or off the floor to attend a conference; they could hold non-urgent issues until you get back.
All these things might make you and others more efficient—able to see the same number of patients you see today in less time, while maintaining or improving quality and cost effectiveness.
Sound familiar? The idea that working at only one site leads to efficiency and quality improvement is one of the underpinnings of the hospitalist concept. Instead of covering the outpatient office and hospital every day, doctors can focus on only the hospital or only the office. But what if you extended that idea to focusing your practice on only one unit within the hospital rather than the whole building? Would that be a good idea and lead to the benefits described above, or would that be taking the idea of “focused practice” too far?
Before answering, I should describe the approaches some practices have taken to pursue the benefits of concentrating patients in one part of the hospital. I’ll refer to this idea as “unit-based hospitalists,” the term current SHM President Rusty Holman uses when talking about this idea.
Locate most hospitalist patients in one unit. This is the most common form of unit-based hospitalists. Most institutions find the closest they can get to unit-based hospitalists is to have all hospitalist admissions go to the same floor when that floor has a bed available and the patient doesn’t require placement elsewhere. In such cases, the hospitalist practice might have something like 50% of patients on that floor and 50% dispersed throughout the hospital (telemetry, ICU, surgery floor). So the whole hospitalist practice has a primary “home” within the hospital, while each hospitalist spends part of each day caring for patients elsewhere. This is not very difficult for most hospitals to implement—and many are because most hospitalist patients end up on the “general medical” floor. This lets the hospitalist spend more time on that unit than any other. She can get to know the staff on that floor better, which might lead to many benefits, including improved satisfaction and efficiency.
Locate individual hospitalists on different hospital units. A more pure, but uncommon, form of unit-based hospitalists involves changing the way hospitalists are placed through the institution rather than changing patient placement. Each hospitalist in the group is assigned to a different nursing unit—or perhaps more than one unit—and sees whichever hospitalist patients are placed there. This system has the advantage of the hospitalist working all or most of the day on the same nursing unit, which can foster excellent teamwork. Instead of the nurse having to figure out which hospitalist to page for a particular patient, he simply needs to know, “Who is our hospitalist today?” and can contact that doctor for issues on most patients. Additionally, because the hospitalist will spend nearly the whole day physically on that unit, paging can be reduced significantly.
Despite its advantages, basing an individual hospitalist on a particular unit of the hospital is uncommon because in its purest form it can lead to terrible hospitalist-patient continuity. And, it’s hard to be confident that the disruptions in continuity are worth the benefits of the unit-based system. For example, the practice may have a patient to admit in the ED but can’t know which hospitalist should see the patient until a room is assigned. The fifth-floor hospitalist might go admit the patient in the ED, only to have the patient end up on the third floor, in which case the third-floor hospitalist would take over the next day. And each time the patient transferred to a new unit, either because of medical needs such as telemetry or simply because the hospital is full and needs to move patients, he would get a new hospitalist.
In addition to problems with continuity for patients who occupy more than one unit during their stay, this system would mean individual hospitalist workloads might get far out of balance. One floor might be very busy, while another is slow or limited by nurse staff shortages, and the respective hospitalists would have a correspondingly out-of-balance workload. A group could decide to address these problems by, for example, having the fifth-floor hospitalist see patients in other parts of the hospital in an effort to provide better hospitalist-patient continuity and address out-of-balance patient loads. But if this happens with any regularity it would mean the group has essentially moved back to a non-unit-based system.
In nearly all hospitals it would be unnecessary and unreasonable to assign a hospitalist to each nursing unit because some units tend to have few hospitalist patients. Yet when patients end up in those units because of medical necessity or bed space needs, one of the hospitalists will have to leave his/her unit to see this patient. If this happens often enough, it begins to dilute or negate the benefit of basing a hospitalist in one or two units.
Although one of the potential benefits of the unit-based model is enhanced relationships and integration among hospitalists and other unit-based clinical staff, it would be difficult to ensure that the same one or two hospitalists always work in a particular unit, and would limit scheduling flexibility dramatically. For example, if Dr. Starsky and Dr. Hutch are the unit-based hospitalists for Unit A, what happens if Dr. Starsky and Dr. Hutch are both scheduled to be off for the same block of days? What happens if both are scheduled to work the same block of days? To obtain the benefits of enhanced relationships and better unit integration, the practice would need to ensure that this scheduling overlap rarely happens—and that’s hard to do.
Where is the sweet spot in grouping patients and hospitalists by nursing unit? There is a wide range of opinion about whether unit-based hospital medicine in any form is worth pursuing. Some hospitalists are convinced that grouping all of their patients on the same unit could decrease efficiency because the doctor is nearly always working within view of patients and families and may be regularly interrupted. I am convinced that assigning each hospitalist to a particular unit in the hospital yields the greatest benefits. But I also think most institutions will find that the complexity and costs of this system are simply too high to justify. In that case, the next best approach might be to locate most hospitalist patients on the same unit unless that unit is full or the patient must be placed elsewhere. There is a good chance this is happening in your hospital—even if it isn’t written in the policy manual. TH
Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson/Flores Associates, a national hospitalist practice management-consulting firm. This column represents his views and is not intended to reflect an official position of SHM.
Would you want all your patients on the same nursing unit? Think about it—no more walking all over the building to see a few patients on each floor.
Because you would be physically present on “your” unit nearly all day, you could develop close working relationships with the nurses and other caregivers, which might improve everyone’s satisfaction with work. Everyone could better anticipate your work flow and communicate this to patients and families. You likely would be paged much less often because the nursing staff could keep track of whether you’re with a patient or off the floor to attend a conference; they could hold non-urgent issues until you get back.
All these things might make you and others more efficient—able to see the same number of patients you see today in less time, while maintaining or improving quality and cost effectiveness.
Sound familiar? The idea that working at only one site leads to efficiency and quality improvement is one of the underpinnings of the hospitalist concept. Instead of covering the outpatient office and hospital every day, doctors can focus on only the hospital or only the office. But what if you extended that idea to focusing your practice on only one unit within the hospital rather than the whole building? Would that be a good idea and lead to the benefits described above, or would that be taking the idea of “focused practice” too far?
Before answering, I should describe the approaches some practices have taken to pursue the benefits of concentrating patients in one part of the hospital. I’ll refer to this idea as “unit-based hospitalists,” the term current SHM President Rusty Holman uses when talking about this idea.
Locate most hospitalist patients in one unit. This is the most common form of unit-based hospitalists. Most institutions find the closest they can get to unit-based hospitalists is to have all hospitalist admissions go to the same floor when that floor has a bed available and the patient doesn’t require placement elsewhere. In such cases, the hospitalist practice might have something like 50% of patients on that floor and 50% dispersed throughout the hospital (telemetry, ICU, surgery floor). So the whole hospitalist practice has a primary “home” within the hospital, while each hospitalist spends part of each day caring for patients elsewhere. This is not very difficult for most hospitals to implement—and many are because most hospitalist patients end up on the “general medical” floor. This lets the hospitalist spend more time on that unit than any other. She can get to know the staff on that floor better, which might lead to many benefits, including improved satisfaction and efficiency.
Locate individual hospitalists on different hospital units. A more pure, but uncommon, form of unit-based hospitalists involves changing the way hospitalists are placed through the institution rather than changing patient placement. Each hospitalist in the group is assigned to a different nursing unit—or perhaps more than one unit—and sees whichever hospitalist patients are placed there. This system has the advantage of the hospitalist working all or most of the day on the same nursing unit, which can foster excellent teamwork. Instead of the nurse having to figure out which hospitalist to page for a particular patient, he simply needs to know, “Who is our hospitalist today?” and can contact that doctor for issues on most patients. Additionally, because the hospitalist will spend nearly the whole day physically on that unit, paging can be reduced significantly.
Despite its advantages, basing an individual hospitalist on a particular unit of the hospital is uncommon because in its purest form it can lead to terrible hospitalist-patient continuity. And, it’s hard to be confident that the disruptions in continuity are worth the benefits of the unit-based system. For example, the practice may have a patient to admit in the ED but can’t know which hospitalist should see the patient until a room is assigned. The fifth-floor hospitalist might go admit the patient in the ED, only to have the patient end up on the third floor, in which case the third-floor hospitalist would take over the next day. And each time the patient transferred to a new unit, either because of medical needs such as telemetry or simply because the hospital is full and needs to move patients, he would get a new hospitalist.
In addition to problems with continuity for patients who occupy more than one unit during their stay, this system would mean individual hospitalist workloads might get far out of balance. One floor might be very busy, while another is slow or limited by nurse staff shortages, and the respective hospitalists would have a correspondingly out-of-balance workload. A group could decide to address these problems by, for example, having the fifth-floor hospitalist see patients in other parts of the hospital in an effort to provide better hospitalist-patient continuity and address out-of-balance patient loads. But if this happens with any regularity it would mean the group has essentially moved back to a non-unit-based system.
In nearly all hospitals it would be unnecessary and unreasonable to assign a hospitalist to each nursing unit because some units tend to have few hospitalist patients. Yet when patients end up in those units because of medical necessity or bed space needs, one of the hospitalists will have to leave his/her unit to see this patient. If this happens often enough, it begins to dilute or negate the benefit of basing a hospitalist in one or two units.
Although one of the potential benefits of the unit-based model is enhanced relationships and integration among hospitalists and other unit-based clinical staff, it would be difficult to ensure that the same one or two hospitalists always work in a particular unit, and would limit scheduling flexibility dramatically. For example, if Dr. Starsky and Dr. Hutch are the unit-based hospitalists for Unit A, what happens if Dr. Starsky and Dr. Hutch are both scheduled to be off for the same block of days? What happens if both are scheduled to work the same block of days? To obtain the benefits of enhanced relationships and better unit integration, the practice would need to ensure that this scheduling overlap rarely happens—and that’s hard to do.
Where is the sweet spot in grouping patients and hospitalists by nursing unit? There is a wide range of opinion about whether unit-based hospital medicine in any form is worth pursuing. Some hospitalists are convinced that grouping all of their patients on the same unit could decrease efficiency because the doctor is nearly always working within view of patients and families and may be regularly interrupted. I am convinced that assigning each hospitalist to a particular unit in the hospital yields the greatest benefits. But I also think most institutions will find that the complexity and costs of this system are simply too high to justify. In that case, the next best approach might be to locate most hospitalist patients on the same unit unless that unit is full or the patient must be placed elsewhere. There is a good chance this is happening in your hospital—even if it isn’t written in the policy manual. TH
Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson/Flores Associates, a national hospitalist practice management-consulting firm. This column represents his views and is not intended to reflect an official position of SHM.