User login
Effects of a self-care education program on quality of life of patients with gastric cancer after gastrectomy
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
A qualitative exploration of supports and unmet needs of diverse young women with breast cancer
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Medicolegal aspects of sleep apnea
Question: A patient who is a commercial truck driver has a long history of snoring and daytime sleepiness. His physical exam was remarkable for obesity, prominent extremities, a large tongue, and a prominent jaw. The treating doctor did not pursue additional work-up or treatment.
One day, the patient fell asleep while driving his truck and hit an oncoming vehicle, resulting in injuries to both patient and the other driver.
In this hypothetical scenario, which of the following statements is best?
A. The doctor may be found negligent for missing the diagnosis of acromegaly and accompanying sleep apnea, and for failing to treat and warn about driving risks.
B. The doctor may be liable to both his patient and the other injured driver.
C. The patient may be terminated from his job as a commercial truck driver, because he poses a danger to himself and the public.
D. Both A and B are correct.
E. All are correct.
Answer: D. Sleep apnea, an underdiagnosed and undertreated disabling condition, places the patient at substantial risk for injuries, chronic hypoxemia, and respiratory arrest. Excessive daytime sleepiness and fatigue may prove hazardous, particularly in those whose undivided attention is a requirement of their jobs, such as with truck drivers.
Diagnosis is established with a formal sleep study (polysomnography), and treatment with a continuous positive airway pressure (CPAP) device is usually effective. In severe or recalcitrant cases, surgical intervention (that is, uvulopalatopharyngoplasty) may be necessary.
In a recent study, Dr. Peter F. Svider of Rutgers New Jersey Medical School, Newark, and his colleagues analyzed 54 litigated sleep apnea cases, of which 33 (61%) were resolved in favor of the defendants (Otolaryngol Head Neck Surg. 2013 Dec;149[6]:947-53). Most of the cases (47) stemmed from patients who underwent surgery with perioperative complications, including death. Inadequate informed consent and monitoring, as well as inappropriate medications, were other findings.
Obstructive sleep apnea is a well-recognized complication of acromegaly with its bony and soft-tissue hypertrophy. The hypothetical situation described above is substantially modified from an actual case in which a 39-year-old man with acromegaly and sleep apnea died from cardiorespiratory arrest (Cornett v. W.O. Moss Regional Hospital, 614 So.2d 189 [La. 1993]). He had presented over the course of several years with repeated complaints of daytime sleepiness and sleeping while driving. Falling asleep in the examination room and abnormal blood gases were giveaway signs. Unfortunately, sleep apnea was left untreated.
Other litigated cases have included anoxic encephalopathy from a lost airway and inappropriate fentanyl dosing during and following aggressive surgery for mild/moderate obstructive sleep apnea, as well as cardiac arrest in a retired sailor during a routine endoscopic procedure. In the latter instance, the plaintiff alleged that there was a failure to take proper precautions in protecting the airway, given that the patient had a known case of obstructive sleep apnea.
What about other liabilities for injuries that are proximately caused by a failure to diagnose and treat?
A doctor is usually liable for negligent care only to his or her own patient, because the duty of care grows out of the doctor-patient relationship and is normally owed to the patient and no one else. However, in very limited circumstances, the duty may extend to other individuals who are family members or even total strangers.
Sleep apnea, by virtue of its sleep disturbances and resulting daytime sleepiness, poses a foreseeable risk of harm. Nonpatient third parties have successfully sued doctors for driving injuries arising out of the failure to diagnose, treat, or warn in a variety of medical conditions.
For example, the Iowa Supreme Court has held that a physician must warn a patient with newly diagnosed seizure disorder about the risks of driving (Freese v. Lemmon, 210 N.W.2d 576 [Iowa 1973]). In that case, a patient with a history of a single seizure injured a woman when he suffered a second seizure while driving.
By analogy, it seems reasonable to assume that the facts given in our hypothetical scenario may give rise to an action against the doctor not only by the patient, but by the injured nonpatient third party as well.
In many jurisdictions, sleep apnea has been accepted as a disability for purposes of the Americans with Disabilities Act (ADA). A disability is defined as a condition evincing substantial interference with a major life activity. Under the ADA, employers are required to make “reasonable accommodation” for disabled employees and cannot simply dismiss them by sole virtue of that disability.
However, qualification for the job must still be shown. One court ruled that a plaintiff with sleep apnea had failed to show that he was a qualified employee even if given his proposed “two-nap-a-day” accommodation (Jackson v. Boise Cascade Corp., 941 F. Supp. 1122 [Ala. 1996]).
Another interesting case involved an anesthesiologist who suffered from sleep apnea and who was snoring and sleeping during surgery. The hospital terminated his contract, and the anesthesiologist filed suit claiming disability discrimination. The 6th U.S. Circuit Court of Appeals affirmed the lower court’s decision in favor of the hospital, finding that the anesthesiologist was fired not because he had a disability, but because he had slept during surgical procedures (Brohm v. JH Properties, 149 F.3d 517 [6th Cir. 1998]).
Distinguishing between discharging someone for unacceptable conduct and discharging someone because of the disability, the court reasoned: “One suffering from chronic sleep deprivation may well be so tired that he cannot stay awake. But such sleep deprivation did not compel Brohm [the anesthesiologist defendant] to administer anesthetics during surgical procedures when he knew he was tired.”
On the other hand, a federal court in 2014 ordered the city of McPherson, Kan., to pay $920,000 in damages to a dismissed police officer suffering from sleep apnea. Although the city cited other factors for the termination, such as insubordination and conduct unbecoming an officer, it had focused on “sleeping on the job” as the basis for the termination. The officer reportedly experienced no further difficulties after he received medical treatment, and the city did not offer the officer an alternative to his graveyard shift or an opportunity to explain his medical condition.
Finally, a discussion of the legal aspects of sleep apnea is incomplete without noting that conducting and billing for sleep studies may occasionally be subject to abuse and/or fraud. The U.S. Department of Health & Human Services Office of Inspector General (OIG) has underscored the high utilization of sleep testing by sleep disorder clinics; in 2010 alone, Medicare reimbursement totaled some $410 million.
The OIG is targeting questionable billing practices under the False Claims Act (31 U.S.C. §§3729-3733) and for self-referrals (Stark Law). Medicare and Medicaid will only reimburse sleep studies that are reasonable and necessary. In addition, there are strict rules such as the mandatory use of properly trained and credentialed sleep technicians, and appropriate level of general physician supervision.
In its most recent prosecution, the federal government is going after the owners of a chain of sleep clinics in the San Francisco Bay area for sleep tests that were conducted in unapproved locations and/or by unlicensed technicians. In addition, the lawsuit alleges a Stark Law violation for self-referrals. The action is being taken in conjunction with a lawsuit filed by a former employee in a whistle-blower action. Under the False Claims Act, whistle-blowers who are private citizens, such as former employees, can file a qui tam action alone or in concert with the government, and they stand to collect a significant (e.g., 25%) portion of any recovery.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Question: A patient who is a commercial truck driver has a long history of snoring and daytime sleepiness. His physical exam was remarkable for obesity, prominent extremities, a large tongue, and a prominent jaw. The treating doctor did not pursue additional work-up or treatment.
One day, the patient fell asleep while driving his truck and hit an oncoming vehicle, resulting in injuries to both patient and the other driver.
In this hypothetical scenario, which of the following statements is best?
A. The doctor may be found negligent for missing the diagnosis of acromegaly and accompanying sleep apnea, and for failing to treat and warn about driving risks.
B. The doctor may be liable to both his patient and the other injured driver.
C. The patient may be terminated from his job as a commercial truck driver, because he poses a danger to himself and the public.
D. Both A and B are correct.
E. All are correct.
Answer: D. Sleep apnea, an underdiagnosed and undertreated disabling condition, places the patient at substantial risk for injuries, chronic hypoxemia, and respiratory arrest. Excessive daytime sleepiness and fatigue may prove hazardous, particularly in those whose undivided attention is a requirement of their jobs, such as with truck drivers.
Diagnosis is established with a formal sleep study (polysomnography), and treatment with a continuous positive airway pressure (CPAP) device is usually effective. In severe or recalcitrant cases, surgical intervention (that is, uvulopalatopharyngoplasty) may be necessary.
In a recent study, Dr. Peter F. Svider of Rutgers New Jersey Medical School, Newark, and his colleagues analyzed 54 litigated sleep apnea cases, of which 33 (61%) were resolved in favor of the defendants (Otolaryngol Head Neck Surg. 2013 Dec;149[6]:947-53). Most of the cases (47) stemmed from patients who underwent surgery with perioperative complications, including death. Inadequate informed consent and monitoring, as well as inappropriate medications, were other findings.
Obstructive sleep apnea is a well-recognized complication of acromegaly with its bony and soft-tissue hypertrophy. The hypothetical situation described above is substantially modified from an actual case in which a 39-year-old man with acromegaly and sleep apnea died from cardiorespiratory arrest (Cornett v. W.O. Moss Regional Hospital, 614 So.2d 189 [La. 1993]). He had presented over the course of several years with repeated complaints of daytime sleepiness and sleeping while driving. Falling asleep in the examination room and abnormal blood gases were giveaway signs. Unfortunately, sleep apnea was left untreated.
Other litigated cases have included anoxic encephalopathy from a lost airway and inappropriate fentanyl dosing during and following aggressive surgery for mild/moderate obstructive sleep apnea, as well as cardiac arrest in a retired sailor during a routine endoscopic procedure. In the latter instance, the plaintiff alleged that there was a failure to take proper precautions in protecting the airway, given that the patient had a known case of obstructive sleep apnea.
What about other liabilities for injuries that are proximately caused by a failure to diagnose and treat?
A doctor is usually liable for negligent care only to his or her own patient, because the duty of care grows out of the doctor-patient relationship and is normally owed to the patient and no one else. However, in very limited circumstances, the duty may extend to other individuals who are family members or even total strangers.
Sleep apnea, by virtue of its sleep disturbances and resulting daytime sleepiness, poses a foreseeable risk of harm. Nonpatient third parties have successfully sued doctors for driving injuries arising out of the failure to diagnose, treat, or warn in a variety of medical conditions.
For example, the Iowa Supreme Court has held that a physician must warn a patient with newly diagnosed seizure disorder about the risks of driving (Freese v. Lemmon, 210 N.W.2d 576 [Iowa 1973]). In that case, a patient with a history of a single seizure injured a woman when he suffered a second seizure while driving.
By analogy, it seems reasonable to assume that the facts given in our hypothetical scenario may give rise to an action against the doctor not only by the patient, but by the injured nonpatient third party as well.
In many jurisdictions, sleep apnea has been accepted as a disability for purposes of the Americans with Disabilities Act (ADA). A disability is defined as a condition evincing substantial interference with a major life activity. Under the ADA, employers are required to make “reasonable accommodation” for disabled employees and cannot simply dismiss them by sole virtue of that disability.
However, qualification for the job must still be shown. One court ruled that a plaintiff with sleep apnea had failed to show that he was a qualified employee even if given his proposed “two-nap-a-day” accommodation (Jackson v. Boise Cascade Corp., 941 F. Supp. 1122 [Ala. 1996]).
Another interesting case involved an anesthesiologist who suffered from sleep apnea and who was snoring and sleeping during surgery. The hospital terminated his contract, and the anesthesiologist filed suit claiming disability discrimination. The 6th U.S. Circuit Court of Appeals affirmed the lower court’s decision in favor of the hospital, finding that the anesthesiologist was fired not because he had a disability, but because he had slept during surgical procedures (Brohm v. JH Properties, 149 F.3d 517 [6th Cir. 1998]).
Distinguishing between discharging someone for unacceptable conduct and discharging someone because of the disability, the court reasoned: “One suffering from chronic sleep deprivation may well be so tired that he cannot stay awake. But such sleep deprivation did not compel Brohm [the anesthesiologist defendant] to administer anesthetics during surgical procedures when he knew he was tired.”
On the other hand, a federal court in 2014 ordered the city of McPherson, Kan., to pay $920,000 in damages to a dismissed police officer suffering from sleep apnea. Although the city cited other factors for the termination, such as insubordination and conduct unbecoming an officer, it had focused on “sleeping on the job” as the basis for the termination. The officer reportedly experienced no further difficulties after he received medical treatment, and the city did not offer the officer an alternative to his graveyard shift or an opportunity to explain his medical condition.
Finally, a discussion of the legal aspects of sleep apnea is incomplete without noting that conducting and billing for sleep studies may occasionally be subject to abuse and/or fraud. The U.S. Department of Health & Human Services Office of Inspector General (OIG) has underscored the high utilization of sleep testing by sleep disorder clinics; in 2010 alone, Medicare reimbursement totaled some $410 million.
The OIG is targeting questionable billing practices under the False Claims Act (31 U.S.C. §§3729-3733) and for self-referrals (Stark Law). Medicare and Medicaid will only reimburse sleep studies that are reasonable and necessary. In addition, there are strict rules such as the mandatory use of properly trained and credentialed sleep technicians, and appropriate level of general physician supervision.
In its most recent prosecution, the federal government is going after the owners of a chain of sleep clinics in the San Francisco Bay area for sleep tests that were conducted in unapproved locations and/or by unlicensed technicians. In addition, the lawsuit alleges a Stark Law violation for self-referrals. The action is being taken in conjunction with a lawsuit filed by a former employee in a whistle-blower action. Under the False Claims Act, whistle-blowers who are private citizens, such as former employees, can file a qui tam action alone or in concert with the government, and they stand to collect a significant (e.g., 25%) portion of any recovery.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Question: A patient who is a commercial truck driver has a long history of snoring and daytime sleepiness. His physical exam was remarkable for obesity, prominent extremities, a large tongue, and a prominent jaw. The treating doctor did not pursue additional work-up or treatment.
One day, the patient fell asleep while driving his truck and hit an oncoming vehicle, resulting in injuries to both patient and the other driver.
In this hypothetical scenario, which of the following statements is best?
A. The doctor may be found negligent for missing the diagnosis of acromegaly and accompanying sleep apnea, and for failing to treat and warn about driving risks.
B. The doctor may be liable to both his patient and the other injured driver.
C. The patient may be terminated from his job as a commercial truck driver, because he poses a danger to himself and the public.
D. Both A and B are correct.
E. All are correct.
Answer: D. Sleep apnea, an underdiagnosed and undertreated disabling condition, places the patient at substantial risk for injuries, chronic hypoxemia, and respiratory arrest. Excessive daytime sleepiness and fatigue may prove hazardous, particularly in those whose undivided attention is a requirement of their jobs, such as with truck drivers.
Diagnosis is established with a formal sleep study (polysomnography), and treatment with a continuous positive airway pressure (CPAP) device is usually effective. In severe or recalcitrant cases, surgical intervention (that is, uvulopalatopharyngoplasty) may be necessary.
In a recent study, Dr. Peter F. Svider of Rutgers New Jersey Medical School, Newark, and his colleagues analyzed 54 litigated sleep apnea cases, of which 33 (61%) were resolved in favor of the defendants (Otolaryngol Head Neck Surg. 2013 Dec;149[6]:947-53). Most of the cases (47) stemmed from patients who underwent surgery with perioperative complications, including death. Inadequate informed consent and monitoring, as well as inappropriate medications, were other findings.
Obstructive sleep apnea is a well-recognized complication of acromegaly with its bony and soft-tissue hypertrophy. The hypothetical situation described above is substantially modified from an actual case in which a 39-year-old man with acromegaly and sleep apnea died from cardiorespiratory arrest (Cornett v. W.O. Moss Regional Hospital, 614 So.2d 189 [La. 1993]). He had presented over the course of several years with repeated complaints of daytime sleepiness and sleeping while driving. Falling asleep in the examination room and abnormal blood gases were giveaway signs. Unfortunately, sleep apnea was left untreated.
Other litigated cases have included anoxic encephalopathy from a lost airway and inappropriate fentanyl dosing during and following aggressive surgery for mild/moderate obstructive sleep apnea, as well as cardiac arrest in a retired sailor during a routine endoscopic procedure. In the latter instance, the plaintiff alleged that there was a failure to take proper precautions in protecting the airway, given that the patient had a known case of obstructive sleep apnea.
What about other liabilities for injuries that are proximately caused by a failure to diagnose and treat?
A doctor is usually liable for negligent care only to his or her own patient, because the duty of care grows out of the doctor-patient relationship and is normally owed to the patient and no one else. However, in very limited circumstances, the duty may extend to other individuals who are family members or even total strangers.
Sleep apnea, by virtue of its sleep disturbances and resulting daytime sleepiness, poses a foreseeable risk of harm. Nonpatient third parties have successfully sued doctors for driving injuries arising out of the failure to diagnose, treat, or warn in a variety of medical conditions.
For example, the Iowa Supreme Court has held that a physician must warn a patient with newly diagnosed seizure disorder about the risks of driving (Freese v. Lemmon, 210 N.W.2d 576 [Iowa 1973]). In that case, a patient with a history of a single seizure injured a woman when he suffered a second seizure while driving.
By analogy, it seems reasonable to assume that the facts given in our hypothetical scenario may give rise to an action against the doctor not only by the patient, but by the injured nonpatient third party as well.
In many jurisdictions, sleep apnea has been accepted as a disability for purposes of the Americans with Disabilities Act (ADA). A disability is defined as a condition evincing substantial interference with a major life activity. Under the ADA, employers are required to make “reasonable accommodation” for disabled employees and cannot simply dismiss them by sole virtue of that disability.
However, qualification for the job must still be shown. One court ruled that a plaintiff with sleep apnea had failed to show that he was a qualified employee even if given his proposed “two-nap-a-day” accommodation (Jackson v. Boise Cascade Corp., 941 F. Supp. 1122 [Ala. 1996]).
Another interesting case involved an anesthesiologist who suffered from sleep apnea and who was snoring and sleeping during surgery. The hospital terminated his contract, and the anesthesiologist filed suit claiming disability discrimination. The 6th U.S. Circuit Court of Appeals affirmed the lower court’s decision in favor of the hospital, finding that the anesthesiologist was fired not because he had a disability, but because he had slept during surgical procedures (Brohm v. JH Properties, 149 F.3d 517 [6th Cir. 1998]).
Distinguishing between discharging someone for unacceptable conduct and discharging someone because of the disability, the court reasoned: “One suffering from chronic sleep deprivation may well be so tired that he cannot stay awake. But such sleep deprivation did not compel Brohm [the anesthesiologist defendant] to administer anesthetics during surgical procedures when he knew he was tired.”
On the other hand, a federal court in 2014 ordered the city of McPherson, Kan., to pay $920,000 in damages to a dismissed police officer suffering from sleep apnea. Although the city cited other factors for the termination, such as insubordination and conduct unbecoming an officer, it had focused on “sleeping on the job” as the basis for the termination. The officer reportedly experienced no further difficulties after he received medical treatment, and the city did not offer the officer an alternative to his graveyard shift or an opportunity to explain his medical condition.
Finally, a discussion of the legal aspects of sleep apnea is incomplete without noting that conducting and billing for sleep studies may occasionally be subject to abuse and/or fraud. The U.S. Department of Health & Human Services Office of Inspector General (OIG) has underscored the high utilization of sleep testing by sleep disorder clinics; in 2010 alone, Medicare reimbursement totaled some $410 million.
The OIG is targeting questionable billing practices under the False Claims Act (31 U.S.C. §§3729-3733) and for self-referrals (Stark Law). Medicare and Medicaid will only reimburse sleep studies that are reasonable and necessary. In addition, there are strict rules such as the mandatory use of properly trained and credentialed sleep technicians, and appropriate level of general physician supervision.
In its most recent prosecution, the federal government is going after the owners of a chain of sleep clinics in the San Francisco Bay area for sleep tests that were conducted in unapproved locations and/or by unlicensed technicians. In addition, the lawsuit alleges a Stark Law violation for self-referrals. The action is being taken in conjunction with a lawsuit filed by a former employee in a whistle-blower action. Under the False Claims Act, whistle-blowers who are private citizens, such as former employees, can file a qui tam action alone or in concert with the government, and they stand to collect a significant (e.g., 25%) portion of any recovery.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Ambition linked to increased creativity in bipolar patients
Heightened ambition seems to be an important aspect of increased creativity in people with bipolar disorder, according to results of two studies by Sheri L. Johnson, Ph.D., and her associates.
In Study One, 22 bipolar patients who identified as highly creative took the WASSUP (Willingly Approached Set of Statistically Unlikely Pursuits) test, an assessment to determine ambition. WASSUP scores were elevated in the group, and a higher score was related to lifetime creative accomplishment in artistic bipolar patients.
In Study Two, 221 undergraduates completed the WASSUP, the Hypomanic Personality Scale (to measure mania risk), and a measure to assess creativity in business projects. Both increased ambition and creativity were linked to increased mania risk, and ambition was related to creativity outside of a bipolar setting as well.
Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.02.021).
Heightened ambition seems to be an important aspect of increased creativity in people with bipolar disorder, according to results of two studies by Sheri L. Johnson, Ph.D., and her associates.
In Study One, 22 bipolar patients who identified as highly creative took the WASSUP (Willingly Approached Set of Statistically Unlikely Pursuits) test, an assessment to determine ambition. WASSUP scores were elevated in the group, and a higher score was related to lifetime creative accomplishment in artistic bipolar patients.
In Study Two, 221 undergraduates completed the WASSUP, the Hypomanic Personality Scale (to measure mania risk), and a measure to assess creativity in business projects. Both increased ambition and creativity were linked to increased mania risk, and ambition was related to creativity outside of a bipolar setting as well.
Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.02.021).
Heightened ambition seems to be an important aspect of increased creativity in people with bipolar disorder, according to results of two studies by Sheri L. Johnson, Ph.D., and her associates.
In Study One, 22 bipolar patients who identified as highly creative took the WASSUP (Willingly Approached Set of Statistically Unlikely Pursuits) test, an assessment to determine ambition. WASSUP scores were elevated in the group, and a higher score was related to lifetime creative accomplishment in artistic bipolar patients.
In Study Two, 221 undergraduates completed the WASSUP, the Hypomanic Personality Scale (to measure mania risk), and a measure to assess creativity in business projects. Both increased ambition and creativity were linked to increased mania risk, and ambition was related to creativity outside of a bipolar setting as well.
Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.02.021).
Hospital readmission following transplantation: identifying risk factors and designing preventive measures
Background About 1 in 7 of all hospitalized patients is readmitted within 30 days of discharge. The cost of readmissions is significant, with Medicare readmissions alone costing the health care system an estimated $28 billion a year.
Objective To identify the rates of and causes for readmission within 100 days of patients receiving a hematopoietic stem cell transplant.
Methods We performed a retrospective review of 235 consecutive transplant recipients (autologous, n = 144; allogeneic, n = 91) to determine rates and causes for readmission within 100 days of patients receiving a transplant. Medical records and hospital readmissions were reviewed for each patient.
Results 36 allogeneic patients accounted for 56 readmissions. 23 autologous patients accounted for 26 readmissions. Autologous transplant recipients were most commonly readmitted for the development of a fever (n = 15 patients) or cardiopulmonary issues (n = 4). The most prevalent reasons for readmission in the allogeneic recipients included a fever (n = 21) or the development or exacerbation of graft-versus-host disease (n = 5). The readmission length of stay was 6 days (median range, 1-91 days) for allogeneic patients and 4 days (median range, 1-22 days) for autologous patients. There was no difference in survival between the readmitted and the non-readmitted cohorts (P = .55 for allogeneic patients; P = .24 for autologous patients). Although allogeneic graft recipients demonstrated a higher readmission rate (39.6%) compared with autologous recipients (16%), none of the variables examined, including age, gender, performance status, diagnosis, remission status at the time of transplant, comorbidities, type of preparative chemotherapy regimen or donor type, identified patients at increased risk for readmission.
Limitations Variations in clinical care, physician practices, and patient characteristics need to be considered when examining readmission rates. Most of the allogeneic patient population included unrelated donor recipients (65%) who received nonmyeloablative conditioning regimens (81% of allogeneic recipients). These features may not be characteristic of other centers.
Conclusions In these high-risk patients, readmissions following a transplant are common. Enhanced predischarge education by nurses and pharmacists, along with ongoing outpatient education and rigorous outpatient follow-up through phone calls or social media may decrease readmission rates.
Click on the PDF icon at the top of this introduction to read the full article.
Background About 1 in 7 of all hospitalized patients is readmitted within 30 days of discharge. The cost of readmissions is significant, with Medicare readmissions alone costing the health care system an estimated $28 billion a year.
Objective To identify the rates of and causes for readmission within 100 days of patients receiving a hematopoietic stem cell transplant.
Methods We performed a retrospective review of 235 consecutive transplant recipients (autologous, n = 144; allogeneic, n = 91) to determine rates and causes for readmission within 100 days of patients receiving a transplant. Medical records and hospital readmissions were reviewed for each patient.
Results 36 allogeneic patients accounted for 56 readmissions. 23 autologous patients accounted for 26 readmissions. Autologous transplant recipients were most commonly readmitted for the development of a fever (n = 15 patients) or cardiopulmonary issues (n = 4). The most prevalent reasons for readmission in the allogeneic recipients included a fever (n = 21) or the development or exacerbation of graft-versus-host disease (n = 5). The readmission length of stay was 6 days (median range, 1-91 days) for allogeneic patients and 4 days (median range, 1-22 days) for autologous patients. There was no difference in survival between the readmitted and the non-readmitted cohorts (P = .55 for allogeneic patients; P = .24 for autologous patients). Although allogeneic graft recipients demonstrated a higher readmission rate (39.6%) compared with autologous recipients (16%), none of the variables examined, including age, gender, performance status, diagnosis, remission status at the time of transplant, comorbidities, type of preparative chemotherapy regimen or donor type, identified patients at increased risk for readmission.
Limitations Variations in clinical care, physician practices, and patient characteristics need to be considered when examining readmission rates. Most of the allogeneic patient population included unrelated donor recipients (65%) who received nonmyeloablative conditioning regimens (81% of allogeneic recipients). These features may not be characteristic of other centers.
Conclusions In these high-risk patients, readmissions following a transplant are common. Enhanced predischarge education by nurses and pharmacists, along with ongoing outpatient education and rigorous outpatient follow-up through phone calls or social media may decrease readmission rates.
Click on the PDF icon at the top of this introduction to read the full article.
Background About 1 in 7 of all hospitalized patients is readmitted within 30 days of discharge. The cost of readmissions is significant, with Medicare readmissions alone costing the health care system an estimated $28 billion a year.
Objective To identify the rates of and causes for readmission within 100 days of patients receiving a hematopoietic stem cell transplant.
Methods We performed a retrospective review of 235 consecutive transplant recipients (autologous, n = 144; allogeneic, n = 91) to determine rates and causes for readmission within 100 days of patients receiving a transplant. Medical records and hospital readmissions were reviewed for each patient.
Results 36 allogeneic patients accounted for 56 readmissions. 23 autologous patients accounted for 26 readmissions. Autologous transplant recipients were most commonly readmitted for the development of a fever (n = 15 patients) or cardiopulmonary issues (n = 4). The most prevalent reasons for readmission in the allogeneic recipients included a fever (n = 21) or the development or exacerbation of graft-versus-host disease (n = 5). The readmission length of stay was 6 days (median range, 1-91 days) for allogeneic patients and 4 days (median range, 1-22 days) for autologous patients. There was no difference in survival between the readmitted and the non-readmitted cohorts (P = .55 for allogeneic patients; P = .24 for autologous patients). Although allogeneic graft recipients demonstrated a higher readmission rate (39.6%) compared with autologous recipients (16%), none of the variables examined, including age, gender, performance status, diagnosis, remission status at the time of transplant, comorbidities, type of preparative chemotherapy regimen or donor type, identified patients at increased risk for readmission.
Limitations Variations in clinical care, physician practices, and patient characteristics need to be considered when examining readmission rates. Most of the allogeneic patient population included unrelated donor recipients (65%) who received nonmyeloablative conditioning regimens (81% of allogeneic recipients). These features may not be characteristic of other centers.
Conclusions In these high-risk patients, readmissions following a transplant are common. Enhanced predischarge education by nurses and pharmacists, along with ongoing outpatient education and rigorous outpatient follow-up through phone calls or social media may decrease readmission rates.
Click on the PDF icon at the top of this introduction to read the full article.
Nail care safety
I recently went to a local salon for a manicure, and when I asked the manicurist not to cut my cuticles, she looked at me as though I was offending her. Shortly thereafter, I took a phone call that swayed my attention, and she secretly dove in and quickly started cutting my cuticles thinking I would not notice. Why is cuticle-cutting a necessary part of nail care ... and almost a rampant ritual?
The cuticle is the protective barrier surrounding the nail plate and nail folds. Biting, pulling, or improper cutting of the cuticle over time can cause long-term damage to the nail plate, such as ridging of the nail, median nail dystrophy, or permanent destruction of the nail plate. Trimming the cuticles can also break the seal that protects the surrounding skin and nails. Not only can the removal of the cuticle introduce infection, but it can also cause deformities in the nail plate itself. Infections to consider around the nail include acute or chronic paronychia, herpetic whitlow, onychomycosis, and warts. These infections can be the direct result of entry from the removal of the cuticle barrier or improperly cleaned and sterilized instruments.
Tools used to remove cuticles can transfer infections. In addition to skin infections, viruses that cause systemic infections, such as hepatitis C, can live in dry blood for up to 3 days and can be transferred on tools that have not been cleaned properly. Sterilized tools must first be cleaned and submerged in antiseptic solutions, then sterilized in an autoclave or a Food and Drug Administration–registered dry-heat sterilizer, not a UV box. UV boxes are commonly used and do not actually sterilize tools; they keep tools clean only if they have been previously sterilized.
The best way to ensure proper sterilization is to check the indicator tape or indicator color on the packaging. Autoclave tape and dry heat sterilizer strips work by changing colors when exposed to a certain temperature (and pressure for the autoclave tape) for a certain amount of time. I routinely check the sterilizing packets and immediately look up the indicator color on the Internet to ensure the color change was correct. I ask about what sterilization techniques the salon uses, and I often require salons to use my own nail care tools (which should be cleaned after every use).
Trimming or cutting cuticles is a bad habit and can be a dangerous salon ritual. Many states, such as New York and Massachusetts, do not allow manicurists to cut the cuticles given blood-borne pathogen risks and improper sanitation; however, this regulation is often loosely enforced. It also creates an endless cycle of cuticle trimming as the growing cuticle can often look frayed – and thus creates the need for them to be cut over and over again. Pushing the cuticle back may be a better option for those who prefer the cosmetic appearance of trimmed cuticles, but it still poses a portal of entry for pathogens.
Let’s educate our patients, the salons, and the regulatory boards to prevent the spread of infection and ensure safe nail care techniques.
Dr. Wesley and Dr. Talakoub are co-contributors to a monthly Aesthetic Dermatology column in Dermatology News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.
I recently went to a local salon for a manicure, and when I asked the manicurist not to cut my cuticles, she looked at me as though I was offending her. Shortly thereafter, I took a phone call that swayed my attention, and she secretly dove in and quickly started cutting my cuticles thinking I would not notice. Why is cuticle-cutting a necessary part of nail care ... and almost a rampant ritual?
The cuticle is the protective barrier surrounding the nail plate and nail folds. Biting, pulling, or improper cutting of the cuticle over time can cause long-term damage to the nail plate, such as ridging of the nail, median nail dystrophy, or permanent destruction of the nail plate. Trimming the cuticles can also break the seal that protects the surrounding skin and nails. Not only can the removal of the cuticle introduce infection, but it can also cause deformities in the nail plate itself. Infections to consider around the nail include acute or chronic paronychia, herpetic whitlow, onychomycosis, and warts. These infections can be the direct result of entry from the removal of the cuticle barrier or improperly cleaned and sterilized instruments.
Tools used to remove cuticles can transfer infections. In addition to skin infections, viruses that cause systemic infections, such as hepatitis C, can live in dry blood for up to 3 days and can be transferred on tools that have not been cleaned properly. Sterilized tools must first be cleaned and submerged in antiseptic solutions, then sterilized in an autoclave or a Food and Drug Administration–registered dry-heat sterilizer, not a UV box. UV boxes are commonly used and do not actually sterilize tools; they keep tools clean only if they have been previously sterilized.
The best way to ensure proper sterilization is to check the indicator tape or indicator color on the packaging. Autoclave tape and dry heat sterilizer strips work by changing colors when exposed to a certain temperature (and pressure for the autoclave tape) for a certain amount of time. I routinely check the sterilizing packets and immediately look up the indicator color on the Internet to ensure the color change was correct. I ask about what sterilization techniques the salon uses, and I often require salons to use my own nail care tools (which should be cleaned after every use).
Trimming or cutting cuticles is a bad habit and can be a dangerous salon ritual. Many states, such as New York and Massachusetts, do not allow manicurists to cut the cuticles given blood-borne pathogen risks and improper sanitation; however, this regulation is often loosely enforced. It also creates an endless cycle of cuticle trimming as the growing cuticle can often look frayed – and thus creates the need for them to be cut over and over again. Pushing the cuticle back may be a better option for those who prefer the cosmetic appearance of trimmed cuticles, but it still poses a portal of entry for pathogens.
Let’s educate our patients, the salons, and the regulatory boards to prevent the spread of infection and ensure safe nail care techniques.
Dr. Wesley and Dr. Talakoub are co-contributors to a monthly Aesthetic Dermatology column in Dermatology News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.
I recently went to a local salon for a manicure, and when I asked the manicurist not to cut my cuticles, she looked at me as though I was offending her. Shortly thereafter, I took a phone call that swayed my attention, and she secretly dove in and quickly started cutting my cuticles thinking I would not notice. Why is cuticle-cutting a necessary part of nail care ... and almost a rampant ritual?
The cuticle is the protective barrier surrounding the nail plate and nail folds. Biting, pulling, or improper cutting of the cuticle over time can cause long-term damage to the nail plate, such as ridging of the nail, median nail dystrophy, or permanent destruction of the nail plate. Trimming the cuticles can also break the seal that protects the surrounding skin and nails. Not only can the removal of the cuticle introduce infection, but it can also cause deformities in the nail plate itself. Infections to consider around the nail include acute or chronic paronychia, herpetic whitlow, onychomycosis, and warts. These infections can be the direct result of entry from the removal of the cuticle barrier or improperly cleaned and sterilized instruments.
Tools used to remove cuticles can transfer infections. In addition to skin infections, viruses that cause systemic infections, such as hepatitis C, can live in dry blood for up to 3 days and can be transferred on tools that have not been cleaned properly. Sterilized tools must first be cleaned and submerged in antiseptic solutions, then sterilized in an autoclave or a Food and Drug Administration–registered dry-heat sterilizer, not a UV box. UV boxes are commonly used and do not actually sterilize tools; they keep tools clean only if they have been previously sterilized.
The best way to ensure proper sterilization is to check the indicator tape or indicator color on the packaging. Autoclave tape and dry heat sterilizer strips work by changing colors when exposed to a certain temperature (and pressure for the autoclave tape) for a certain amount of time. I routinely check the sterilizing packets and immediately look up the indicator color on the Internet to ensure the color change was correct. I ask about what sterilization techniques the salon uses, and I often require salons to use my own nail care tools (which should be cleaned after every use).
Trimming or cutting cuticles is a bad habit and can be a dangerous salon ritual. Many states, such as New York and Massachusetts, do not allow manicurists to cut the cuticles given blood-borne pathogen risks and improper sanitation; however, this regulation is often loosely enforced. It also creates an endless cycle of cuticle trimming as the growing cuticle can often look frayed – and thus creates the need for them to be cut over and over again. Pushing the cuticle back may be a better option for those who prefer the cosmetic appearance of trimmed cuticles, but it still poses a portal of entry for pathogens.
Let’s educate our patients, the salons, and the regulatory boards to prevent the spread of infection and ensure safe nail care techniques.
Dr. Wesley and Dr. Talakoub are co-contributors to a monthly Aesthetic Dermatology column in Dermatology News. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.
Implementation of the 21-Gene Risk Score Assay, OncotypeDx Breast, Within the VA
Background: The number of veterans diagnosed and treated for breast cancer within the VHA is increasing. The VA Central Cancer Registry (VACCR) reported 504 and 624 newly diagnosed patients in 2011 and 2012, respectively. Molecular testing for cancer treatment is also increasing, but there are few studies evaluating utilization and health outcomes of testing. This study examined utilization of OncotypeDx breast (Genomic Health Inc., Redwood City, CA), a prognostic 21-gene expression genomic test within the VA.
Methods: Patient-level test orders and results from January 2011 until December 2014 were provided by Genomic Health. Data for years 2011 and 2012 were merged with the VACCR. We identified OncotypeDx-eligible patients using reported clinical and pathologic stage of I or II, hor-mone receptor/HER2 (HR/HER) status, and 10-year life expectancy (aged < 75 years). Bivariate analyses were conducted to compare distributions of characteristics by status of testing. A multivariate logistic regression model was developed to identify patient, site of care, and regional factors that predict testing.
Results: There were 585 OncotypeDx breast assays ordered by VA and non-VA providers from 2011 until 2014. Testing increased from 65 tests in 2011 to 199 in 2014. Characteristics of patients tested were 97% female; median age 58 years (range 26-85 years ; 24% aged < 50 years). Of the 204 tests that were performed by Genomic Health during 2011/2012 time frame, 104 veterans were matched to VACCR data. Of 418 eligible veterans, 21.05% (88) were tested. There were 16 veterans who underwent testing but were not eligible due to age, stage, or HR/HER status. There were no statistically significant differences in use of testing by age or race. Recurrence score for veterans tested ranged from 0-50 (median = 17.40, SD 10.91); 58 (55.77%) low, 35 (33.65%) moderate, and 11 (10.58%) high risk of recurrence. Chemotherapy was used by 26 (25%) veterans who underwent testing and by 395 (38.16%) veterans not tested (P < .025).
Conclusions: There has been a rapid increase in use of the 21-gene risk score test among patients with breast cancer within the VA. Ongoing research will examine regional/site of care variations in access, and we will analyze the influence of testing on health outcomes.
Background: The number of veterans diagnosed and treated for breast cancer within the VHA is increasing. The VA Central Cancer Registry (VACCR) reported 504 and 624 newly diagnosed patients in 2011 and 2012, respectively. Molecular testing for cancer treatment is also increasing, but there are few studies evaluating utilization and health outcomes of testing. This study examined utilization of OncotypeDx breast (Genomic Health Inc., Redwood City, CA), a prognostic 21-gene expression genomic test within the VA.
Methods: Patient-level test orders and results from January 2011 until December 2014 were provided by Genomic Health. Data for years 2011 and 2012 were merged with the VACCR. We identified OncotypeDx-eligible patients using reported clinical and pathologic stage of I or II, hor-mone receptor/HER2 (HR/HER) status, and 10-year life expectancy (aged < 75 years). Bivariate analyses were conducted to compare distributions of characteristics by status of testing. A multivariate logistic regression model was developed to identify patient, site of care, and regional factors that predict testing.
Results: There were 585 OncotypeDx breast assays ordered by VA and non-VA providers from 2011 until 2014. Testing increased from 65 tests in 2011 to 199 in 2014. Characteristics of patients tested were 97% female; median age 58 years (range 26-85 years ; 24% aged < 50 years). Of the 204 tests that were performed by Genomic Health during 2011/2012 time frame, 104 veterans were matched to VACCR data. Of 418 eligible veterans, 21.05% (88) were tested. There were 16 veterans who underwent testing but were not eligible due to age, stage, or HR/HER status. There were no statistically significant differences in use of testing by age or race. Recurrence score for veterans tested ranged from 0-50 (median = 17.40, SD 10.91); 58 (55.77%) low, 35 (33.65%) moderate, and 11 (10.58%) high risk of recurrence. Chemotherapy was used by 26 (25%) veterans who underwent testing and by 395 (38.16%) veterans not tested (P < .025).
Conclusions: There has been a rapid increase in use of the 21-gene risk score test among patients with breast cancer within the VA. Ongoing research will examine regional/site of care variations in access, and we will analyze the influence of testing on health outcomes.
Background: The number of veterans diagnosed and treated for breast cancer within the VHA is increasing. The VA Central Cancer Registry (VACCR) reported 504 and 624 newly diagnosed patients in 2011 and 2012, respectively. Molecular testing for cancer treatment is also increasing, but there are few studies evaluating utilization and health outcomes of testing. This study examined utilization of OncotypeDx breast (Genomic Health Inc., Redwood City, CA), a prognostic 21-gene expression genomic test within the VA.
Methods: Patient-level test orders and results from January 2011 until December 2014 were provided by Genomic Health. Data for years 2011 and 2012 were merged with the VACCR. We identified OncotypeDx-eligible patients using reported clinical and pathologic stage of I or II, hor-mone receptor/HER2 (HR/HER) status, and 10-year life expectancy (aged < 75 years). Bivariate analyses were conducted to compare distributions of characteristics by status of testing. A multivariate logistic regression model was developed to identify patient, site of care, and regional factors that predict testing.
Results: There were 585 OncotypeDx breast assays ordered by VA and non-VA providers from 2011 until 2014. Testing increased from 65 tests in 2011 to 199 in 2014. Characteristics of patients tested were 97% female; median age 58 years (range 26-85 years ; 24% aged < 50 years). Of the 204 tests that were performed by Genomic Health during 2011/2012 time frame, 104 veterans were matched to VACCR data. Of 418 eligible veterans, 21.05% (88) were tested. There were 16 veterans who underwent testing but were not eligible due to age, stage, or HR/HER status. There were no statistically significant differences in use of testing by age or race. Recurrence score for veterans tested ranged from 0-50 (median = 17.40, SD 10.91); 58 (55.77%) low, 35 (33.65%) moderate, and 11 (10.58%) high risk of recurrence. Chemotherapy was used by 26 (25%) veterans who underwent testing and by 395 (38.16%) veterans not tested (P < .025).
Conclusions: There has been a rapid increase in use of the 21-gene risk score test among patients with breast cancer within the VA. Ongoing research will examine regional/site of care variations in access, and we will analyze the influence of testing on health outcomes.
Natalizumab-Associated Melanoma: A Report of 139 Cases From the Southern Network on Adverse Reactions (SONAR)
Background: Natalizumab is an effective immunosuppressive therapy for multiple sclerosis (MS) that received its initial FDA approval in 2004. Its most notable toxicity is progressive multifocal leukoencephalopathy (PML), an opportunistic infection that is the focus of an FDA-mandated registry, TOUCH. The Southern Network on Adverse Reactions identified a fatal case of natalizumab-associated urethral melanoma and undertook an extensive evaluation of all cases of natalizumab-associated melanoma included in the FDA’s Adverse Event Reporting System (FAERS) (between 2005 and 2014).
Methods: Patient characteristics were determined from the FAERS reports and put into a comprehensive dataset. The quality of these reports was assessed based on a 15-point scale of various clinical, demographic, and pharmacy components. Cases were identified as being reported through the TOUCH system, using TOUCH information but reporting outside the system, not using TOUCH at all in the U.S. or not U.S. Quality scores and their components within the 4 Touch groups were statistically compared across all attributes using the mathematical programming-based statistical methodology univariate optimal discriminant analysis.
Results: The mean patient age at the time of diagnosis of melanoma was 46 years (SD 11). Seventeen patients were diagnosed with cutaneous melanoma developing in nonsun-exposed areas. We found that cases reported through the TOUCH registry were of lower quality (mean score 7.7) compared with others that reported outside of the U.S. (mean score 8.5, P < .008). Those cases reported through the TOUCH system were less likely to report the site of melanoma (P < .019) and have overall lower clinical scores (P < .04) compared with reports using TOUCH information but reporting outside of the system.
Conclusions: Our findings suggest that in the U.S., the TOUCH Registry should be expanded to require clinicians to report details of natalizumab-associated melanoma, an opportunistic illness that frequently develops in immunocompromised persons. Also, the FDA-approved product label for natalizumab should be revised to include information on occurrences of melanoma among natalizumab-treated MS patients, particularly those who have cutaneous nevi prior to natalizumab initiation. Natalizumab-treated MS patients and their physicians should be vigilant for changes in nevi appearances and development of new cutaneous lesions (particularly in nonsun-exposed cutaneous areas).
Background: Natalizumab is an effective immunosuppressive therapy for multiple sclerosis (MS) that received its initial FDA approval in 2004. Its most notable toxicity is progressive multifocal leukoencephalopathy (PML), an opportunistic infection that is the focus of an FDA-mandated registry, TOUCH. The Southern Network on Adverse Reactions identified a fatal case of natalizumab-associated urethral melanoma and undertook an extensive evaluation of all cases of natalizumab-associated melanoma included in the FDA’s Adverse Event Reporting System (FAERS) (between 2005 and 2014).
Methods: Patient characteristics were determined from the FAERS reports and put into a comprehensive dataset. The quality of these reports was assessed based on a 15-point scale of various clinical, demographic, and pharmacy components. Cases were identified as being reported through the TOUCH system, using TOUCH information but reporting outside the system, not using TOUCH at all in the U.S. or not U.S. Quality scores and their components within the 4 Touch groups were statistically compared across all attributes using the mathematical programming-based statistical methodology univariate optimal discriminant analysis.
Results: The mean patient age at the time of diagnosis of melanoma was 46 years (SD 11). Seventeen patients were diagnosed with cutaneous melanoma developing in nonsun-exposed areas. We found that cases reported through the TOUCH registry were of lower quality (mean score 7.7) compared with others that reported outside of the U.S. (mean score 8.5, P < .008). Those cases reported through the TOUCH system were less likely to report the site of melanoma (P < .019) and have overall lower clinical scores (P < .04) compared with reports using TOUCH information but reporting outside of the system.
Conclusions: Our findings suggest that in the U.S., the TOUCH Registry should be expanded to require clinicians to report details of natalizumab-associated melanoma, an opportunistic illness that frequently develops in immunocompromised persons. Also, the FDA-approved product label for natalizumab should be revised to include information on occurrences of melanoma among natalizumab-treated MS patients, particularly those who have cutaneous nevi prior to natalizumab initiation. Natalizumab-treated MS patients and their physicians should be vigilant for changes in nevi appearances and development of new cutaneous lesions (particularly in nonsun-exposed cutaneous areas).
Background: Natalizumab is an effective immunosuppressive therapy for multiple sclerosis (MS) that received its initial FDA approval in 2004. Its most notable toxicity is progressive multifocal leukoencephalopathy (PML), an opportunistic infection that is the focus of an FDA-mandated registry, TOUCH. The Southern Network on Adverse Reactions identified a fatal case of natalizumab-associated urethral melanoma and undertook an extensive evaluation of all cases of natalizumab-associated melanoma included in the FDA’s Adverse Event Reporting System (FAERS) (between 2005 and 2014).
Methods: Patient characteristics were determined from the FAERS reports and put into a comprehensive dataset. The quality of these reports was assessed based on a 15-point scale of various clinical, demographic, and pharmacy components. Cases were identified as being reported through the TOUCH system, using TOUCH information but reporting outside the system, not using TOUCH at all in the U.S. or not U.S. Quality scores and their components within the 4 Touch groups were statistically compared across all attributes using the mathematical programming-based statistical methodology univariate optimal discriminant analysis.
Results: The mean patient age at the time of diagnosis of melanoma was 46 years (SD 11). Seventeen patients were diagnosed with cutaneous melanoma developing in nonsun-exposed areas. We found that cases reported through the TOUCH registry were of lower quality (mean score 7.7) compared with others that reported outside of the U.S. (mean score 8.5, P < .008). Those cases reported through the TOUCH system were less likely to report the site of melanoma (P < .019) and have overall lower clinical scores (P < .04) compared with reports using TOUCH information but reporting outside of the system.
Conclusions: Our findings suggest that in the U.S., the TOUCH Registry should be expanded to require clinicians to report details of natalizumab-associated melanoma, an opportunistic illness that frequently develops in immunocompromised persons. Also, the FDA-approved product label for natalizumab should be revised to include information on occurrences of melanoma among natalizumab-treated MS patients, particularly those who have cutaneous nevi prior to natalizumab initiation. Natalizumab-treated MS patients and their physicians should be vigilant for changes in nevi appearances and development of new cutaneous lesions (particularly in nonsun-exposed cutaneous areas).
Patterns in the Use of Neoadjuvant and Adjuvant Therapy in Stage II/III Rectal Cancer and Associated Survival
Background: A 2004 German study found preoperative chemoradiotherapy followed by postoperative chemotherapy provided increased local control and reduced toxicity over postoperative chemoradiotherapy in stage II/III rectal cancer, though a statistically significant advantage in overall survival was not observed. We examined similar survival differences and the utilization of appropriate therapy on a larger scale.
Methods: This study retrospectively examined patients diagnosed with stage II/III rectal cancer from 2006 to 2011 using a participant user file from the National Cancer Database, a data registry jointly sponsored by the American College of Surgeons and the American Cancer Society capturing approximately 70% of newly diagnosed cancer cases nationwide. Overall survival differences between treatment modalities were assessed using life tables and pairwise comparisons, and changes in the utilization of these treatments were examined.
Results: Of 40,546 patients diagnosed with stage II/III rectal cancer, 27,014 (66.6%) received therapy consisting of surgery, chemotherapy, and radiation. Those administered preoperative chemoradiotherapy followed by postoperative chemotherapy had the highest 5-year survival rate (stage II 81.4%, stage III 71.2%), but the difference was not significant against postoperative chemoradiotherapy in stage III disease (69.9%) after the Bonferroni correction was applied. Five-year survival was higher in postoperative (stage II 76.0%, stage III 69.9%) than that in preoperative (stage II 72.5%, stage III: 65.8%) chemoradiotherapy in both stages. Preoperative chemoradiotherapy remains the most commonly administered (60.6% in stage II and 46.0% in stage III), but preoperative chemoradio-therapy followed by postoperative chemotherapy has been steadily rising (2006: 12.2% in stage II, 16.5% in stage III vs 2011: 22.8% in stage II, 28.0% in stage III).
Conclusions: A survival benefit of preoperative chemoradiotherapy followed by postoperative chemotherapy in stage II disease was observed, along with a nonsignificant advantage in stage III disease. The utilization of preoperative chemoradiotherapy followed by postoperative chemotherapy increased, but preoperative chemoradiotherapy remained most prevalent despite its lesser overall survival. Cox regression will be performed prior to the AVAHO annual meeting to evaluate the impact of other characteristics such as age, insurance, income, and comorbidities on survival.
Background: A 2004 German study found preoperative chemoradiotherapy followed by postoperative chemotherapy provided increased local control and reduced toxicity over postoperative chemoradiotherapy in stage II/III rectal cancer, though a statistically significant advantage in overall survival was not observed. We examined similar survival differences and the utilization of appropriate therapy on a larger scale.
Methods: This study retrospectively examined patients diagnosed with stage II/III rectal cancer from 2006 to 2011 using a participant user file from the National Cancer Database, a data registry jointly sponsored by the American College of Surgeons and the American Cancer Society capturing approximately 70% of newly diagnosed cancer cases nationwide. Overall survival differences between treatment modalities were assessed using life tables and pairwise comparisons, and changes in the utilization of these treatments were examined.
Results: Of 40,546 patients diagnosed with stage II/III rectal cancer, 27,014 (66.6%) received therapy consisting of surgery, chemotherapy, and radiation. Those administered preoperative chemoradiotherapy followed by postoperative chemotherapy had the highest 5-year survival rate (stage II 81.4%, stage III 71.2%), but the difference was not significant against postoperative chemoradiotherapy in stage III disease (69.9%) after the Bonferroni correction was applied. Five-year survival was higher in postoperative (stage II 76.0%, stage III 69.9%) than that in preoperative (stage II 72.5%, stage III: 65.8%) chemoradiotherapy in both stages. Preoperative chemoradiotherapy remains the most commonly administered (60.6% in stage II and 46.0% in stage III), but preoperative chemoradio-therapy followed by postoperative chemotherapy has been steadily rising (2006: 12.2% in stage II, 16.5% in stage III vs 2011: 22.8% in stage II, 28.0% in stage III).
Conclusions: A survival benefit of preoperative chemoradiotherapy followed by postoperative chemotherapy in stage II disease was observed, along with a nonsignificant advantage in stage III disease. The utilization of preoperative chemoradiotherapy followed by postoperative chemotherapy increased, but preoperative chemoradiotherapy remained most prevalent despite its lesser overall survival. Cox regression will be performed prior to the AVAHO annual meeting to evaluate the impact of other characteristics such as age, insurance, income, and comorbidities on survival.
Background: A 2004 German study found preoperative chemoradiotherapy followed by postoperative chemotherapy provided increased local control and reduced toxicity over postoperative chemoradiotherapy in stage II/III rectal cancer, though a statistically significant advantage in overall survival was not observed. We examined similar survival differences and the utilization of appropriate therapy on a larger scale.
Methods: This study retrospectively examined patients diagnosed with stage II/III rectal cancer from 2006 to 2011 using a participant user file from the National Cancer Database, a data registry jointly sponsored by the American College of Surgeons and the American Cancer Society capturing approximately 70% of newly diagnosed cancer cases nationwide. Overall survival differences between treatment modalities were assessed using life tables and pairwise comparisons, and changes in the utilization of these treatments were examined.
Results: Of 40,546 patients diagnosed with stage II/III rectal cancer, 27,014 (66.6%) received therapy consisting of surgery, chemotherapy, and radiation. Those administered preoperative chemoradiotherapy followed by postoperative chemotherapy had the highest 5-year survival rate (stage II 81.4%, stage III 71.2%), but the difference was not significant against postoperative chemoradiotherapy in stage III disease (69.9%) after the Bonferroni correction was applied. Five-year survival was higher in postoperative (stage II 76.0%, stage III 69.9%) than that in preoperative (stage II 72.5%, stage III: 65.8%) chemoradiotherapy in both stages. Preoperative chemoradiotherapy remains the most commonly administered (60.6% in stage II and 46.0% in stage III), but preoperative chemoradio-therapy followed by postoperative chemotherapy has been steadily rising (2006: 12.2% in stage II, 16.5% in stage III vs 2011: 22.8% in stage II, 28.0% in stage III).
Conclusions: A survival benefit of preoperative chemoradiotherapy followed by postoperative chemotherapy in stage II disease was observed, along with a nonsignificant advantage in stage III disease. The utilization of preoperative chemoradiotherapy followed by postoperative chemotherapy increased, but preoperative chemoradiotherapy remained most prevalent despite its lesser overall survival. Cox regression will be performed prior to the AVAHO annual meeting to evaluate the impact of other characteristics such as age, insurance, income, and comorbidities on survival.
Stage IV Rectal Cancer Trends by Year: A Review of the National Cancer Database, 1998 to 2009
Background: The arrival of novel surgical techniques and chemotherapeutic agents has changed the range of available treatments and improved outcomes for stage IV rectal cancers. This is the largest study on stage IV rectal cancer to evaluate the change in treatment strategy and corresponding mortality from 1998 to 2009.
Methods: A population-based study was conducted using the National Cancer Database (1998-2009), which contains 70% of all cancer diagnoses in the U.S. After exclusion criteria were met, 25,046 stage IV rectal cancer patients were analyzed. Treatment modalities were compared by year of diagnosis between 1998 and 2009. Life tables were used to determine mortality by year. All statistics were run on SPSS Version 22 (IBM, Armonk, NY).
Results: Overall survival in stage IV rectal cancer has increased from 1998 to 2009 for 1-year survival (50% vs 61%) and 5-year survival (7% vs 12%). Analysis by treatment revealed that chemotherapy with radiation was most prevalent (20.6%) in 1998, but chemotherapy alone became the predominant treatment (25%) in 2009. Surgery as a planned first course of treatment decreased from 51.5% in 1998 to 27.2% in 2009, with a concordant increase in chemotherapy from 8.4% to 25% in that time frame. The largest 5-year survival increase across these years included surgery only (6% to 15%), surgery and chemotherapy (8% to 23%), and trimodal therapy (15% to 27%).
Conclusions: The outcomes for stage IV rectal cancer have meaningfully improved from 1998 to 2009, as evidenced by the significant improvement in 1- and 5-year survival. There has been a general trend to treat with chemotherapy and avoid surgery as a planned first course of treatment, despite improvement in mortality for both. Survival rates remain highest with trimodal therapy, but 5-year survival for surgery with chemotherapy and surgery only has also significantly improved from 1998 to 2009. Prior to the AVAHO annual meeting, we will conduct a multivariate analysis to evaluate other influences on survival such as age, comorbidities, insurance, education, and income.
Background: The arrival of novel surgical techniques and chemotherapeutic agents has changed the range of available treatments and improved outcomes for stage IV rectal cancers. This is the largest study on stage IV rectal cancer to evaluate the change in treatment strategy and corresponding mortality from 1998 to 2009.
Methods: A population-based study was conducted using the National Cancer Database (1998-2009), which contains 70% of all cancer diagnoses in the U.S. After exclusion criteria were met, 25,046 stage IV rectal cancer patients were analyzed. Treatment modalities were compared by year of diagnosis between 1998 and 2009. Life tables were used to determine mortality by year. All statistics were run on SPSS Version 22 (IBM, Armonk, NY).
Results: Overall survival in stage IV rectal cancer has increased from 1998 to 2009 for 1-year survival (50% vs 61%) and 5-year survival (7% vs 12%). Analysis by treatment revealed that chemotherapy with radiation was most prevalent (20.6%) in 1998, but chemotherapy alone became the predominant treatment (25%) in 2009. Surgery as a planned first course of treatment decreased from 51.5% in 1998 to 27.2% in 2009, with a concordant increase in chemotherapy from 8.4% to 25% in that time frame. The largest 5-year survival increase across these years included surgery only (6% to 15%), surgery and chemotherapy (8% to 23%), and trimodal therapy (15% to 27%).
Conclusions: The outcomes for stage IV rectal cancer have meaningfully improved from 1998 to 2009, as evidenced by the significant improvement in 1- and 5-year survival. There has been a general trend to treat with chemotherapy and avoid surgery as a planned first course of treatment, despite improvement in mortality for both. Survival rates remain highest with trimodal therapy, but 5-year survival for surgery with chemotherapy and surgery only has also significantly improved from 1998 to 2009. Prior to the AVAHO annual meeting, we will conduct a multivariate analysis to evaluate other influences on survival such as age, comorbidities, insurance, education, and income.
Background: The arrival of novel surgical techniques and chemotherapeutic agents has changed the range of available treatments and improved outcomes for stage IV rectal cancers. This is the largest study on stage IV rectal cancer to evaluate the change in treatment strategy and corresponding mortality from 1998 to 2009.
Methods: A population-based study was conducted using the National Cancer Database (1998-2009), which contains 70% of all cancer diagnoses in the U.S. After exclusion criteria were met, 25,046 stage IV rectal cancer patients were analyzed. Treatment modalities were compared by year of diagnosis between 1998 and 2009. Life tables were used to determine mortality by year. All statistics were run on SPSS Version 22 (IBM, Armonk, NY).
Results: Overall survival in stage IV rectal cancer has increased from 1998 to 2009 for 1-year survival (50% vs 61%) and 5-year survival (7% vs 12%). Analysis by treatment revealed that chemotherapy with radiation was most prevalent (20.6%) in 1998, but chemotherapy alone became the predominant treatment (25%) in 2009. Surgery as a planned first course of treatment decreased from 51.5% in 1998 to 27.2% in 2009, with a concordant increase in chemotherapy from 8.4% to 25% in that time frame. The largest 5-year survival increase across these years included surgery only (6% to 15%), surgery and chemotherapy (8% to 23%), and trimodal therapy (15% to 27%).
Conclusions: The outcomes for stage IV rectal cancer have meaningfully improved from 1998 to 2009, as evidenced by the significant improvement in 1- and 5-year survival. There has been a general trend to treat with chemotherapy and avoid surgery as a planned first course of treatment, despite improvement in mortality for both. Survival rates remain highest with trimodal therapy, but 5-year survival for surgery with chemotherapy and surgery only has also significantly improved from 1998 to 2009. Prior to the AVAHO annual meeting, we will conduct a multivariate analysis to evaluate other influences on survival such as age, comorbidities, insurance, education, and income.