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Facing a medical board investigation
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
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].
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
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].
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
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].
October 2016 Quiz 2
Q2: Answer: C
Critique
Isolated gastric varices can be a complication of splenic vein thrombosis. The splenic vein courses superior to the pancreas from the splenic hilum to the main portal vein. Recurrent (or severe acute) inflammation of the pancreas can lead to splenic vein thrombosis, which can cause gastric varices due to backup of blood flow into the short gastric veins. The incidence of gastric varices in those with splenic vein thrombosis ranges from 15% to 55%.
Diagnosis can be made with a CT of the abdomen with contrast, and definitive treatment is splenectomy. Bleeding from a splenic artery pseudoaneurysm can also occur after pancreatitis (hemosuccus pancreaticus), and causes hemodynanically significant bleeding into the peritoneum or the bowel lumen via the pancreatic duct. However, it does not result in gastric varices.
Reference
- Henry Z., Uppal D., Caldwell S., et al. Gastric and ectopic varices. Clin Liver Dis. 2014;18:371-88.
Q2: Answer: C
Critique
Isolated gastric varices can be a complication of splenic vein thrombosis. The splenic vein courses superior to the pancreas from the splenic hilum to the main portal vein. Recurrent (or severe acute) inflammation of the pancreas can lead to splenic vein thrombosis, which can cause gastric varices due to backup of blood flow into the short gastric veins. The incidence of gastric varices in those with splenic vein thrombosis ranges from 15% to 55%.
Diagnosis can be made with a CT of the abdomen with contrast, and definitive treatment is splenectomy. Bleeding from a splenic artery pseudoaneurysm can also occur after pancreatitis (hemosuccus pancreaticus), and causes hemodynanically significant bleeding into the peritoneum or the bowel lumen via the pancreatic duct. However, it does not result in gastric varices.
Q2: Answer: C
Critique
Isolated gastric varices can be a complication of splenic vein thrombosis. The splenic vein courses superior to the pancreas from the splenic hilum to the main portal vein. Recurrent (or severe acute) inflammation of the pancreas can lead to splenic vein thrombosis, which can cause gastric varices due to backup of blood flow into the short gastric veins. The incidence of gastric varices in those with splenic vein thrombosis ranges from 15% to 55%.
Diagnosis can be made with a CT of the abdomen with contrast, and definitive treatment is splenectomy. Bleeding from a splenic artery pseudoaneurysm can also occur after pancreatitis (hemosuccus pancreaticus), and causes hemodynanically significant bleeding into the peritoneum or the bowel lumen via the pancreatic duct. However, it does not result in gastric varices.
Reference
- Henry Z., Uppal D., Caldwell S., et al. Gastric and ectopic varices. Clin Liver Dis. 2014;18:371-88.
Reference
- Henry Z., Uppal D., Caldwell S., et al. Gastric and ectopic varices. Clin Liver Dis. 2014;18:371-88.
A 52-year-old woman with a history of both alcohol and IV drug abuse presents to the emergency department with hematemesis and melena. She was recently discharged from the hospital after an admission for severe acute pancreatitis and has been hospitalized multiple times with alcoholic pancreatitis. After resuscitation, she undergoes urgent endoscopy and is found to have a large gastric varix with a red wale sign, but no active bleeding. There are no esophageal varices.
October 2016 Quiz 1
Q1: Answer: A
Rationale
Vibrio cholerae is a cause of secretory diarrhea. Fecal osmotic gap calculation can be useful in the evaluation of a patient with chronic diarrhea to differentiate between osmotic and secretory diarrhea. It is calculated by subtracting measured fecal electrolytes from normal lumen osmolality (290 – 2(fecal Na+ fecal K)). Secretory diarrhea is characterized by a fecal osmotic gap of less than 50 mOsm/kg, therefore answer A is the correct answer. Osmotic diarrhea is characterized by a fecal osmotic gap greater than 50 mOsm/kg or more specifically, more than 100 mOsm/kg, therefore answer B is incorrect. Accurate fecal osmotic gap calculation depends on normal stool osmolality, which is 290 mOsm/kg. Hypertonic (answer D) or dilute (answer C) stool samples are not appropriate for the calculation of the fecal osmotic gap, therefore answer C and D are incorrect.
Reference
- Eherer A.J., Fordtran J.S. Fecal osmotic gap and pH in experimental diarrhea of various causes. Gastroenterology. 1992;103:545-51.
Q1: Answer: A
Rationale
Vibrio cholerae is a cause of secretory diarrhea. Fecal osmotic gap calculation can be useful in the evaluation of a patient with chronic diarrhea to differentiate between osmotic and secretory diarrhea. It is calculated by subtracting measured fecal electrolytes from normal lumen osmolality (290 – 2(fecal Na+ fecal K)). Secretory diarrhea is characterized by a fecal osmotic gap of less than 50 mOsm/kg, therefore answer A is the correct answer. Osmotic diarrhea is characterized by a fecal osmotic gap greater than 50 mOsm/kg or more specifically, more than 100 mOsm/kg, therefore answer B is incorrect. Accurate fecal osmotic gap calculation depends on normal stool osmolality, which is 290 mOsm/kg. Hypertonic (answer D) or dilute (answer C) stool samples are not appropriate for the calculation of the fecal osmotic gap, therefore answer C and D are incorrect.
Q1: Answer: A
Rationale
Vibrio cholerae is a cause of secretory diarrhea. Fecal osmotic gap calculation can be useful in the evaluation of a patient with chronic diarrhea to differentiate between osmotic and secretory diarrhea. It is calculated by subtracting measured fecal electrolytes from normal lumen osmolality (290 – 2(fecal Na+ fecal K)). Secretory diarrhea is characterized by a fecal osmotic gap of less than 50 mOsm/kg, therefore answer A is the correct answer. Osmotic diarrhea is characterized by a fecal osmotic gap greater than 50 mOsm/kg or more specifically, more than 100 mOsm/kg, therefore answer B is incorrect. Accurate fecal osmotic gap calculation depends on normal stool osmolality, which is 290 mOsm/kg. Hypertonic (answer D) or dilute (answer C) stool samples are not appropriate for the calculation of the fecal osmotic gap, therefore answer C and D are incorrect.
Reference
- Eherer A.J., Fordtran J.S. Fecal osmotic gap and pH in experimental diarrhea of various causes. Gastroenterology. 1992;103:545-51.
Reference
- Eherer A.J., Fordtran J.S. Fecal osmotic gap and pH in experimental diarrhea of various causes. Gastroenterology. 1992;103:545-51.
A 37-year-old man presents with acute nausea, vomiting, and diarrhea consistent with an acute Vibrio cholerae infection.
Ribociclib/letrozole combo a ‘game changer’ in advanced breast cancer
COPENHAGEN – Progression-free survival for postmenopausal women with hormone receptor–positive advanced breast cancer was significantly improved when the cyclin-dependent kinase inhibitor ribociclib was added to standard therapy with the aromatase inhibitor letrozole, interim analysis from a phase III randomized trial shows.
After 18 months of follow-up, the risk of progression-free survival (PFS) among patients assigned to receive letrozole (Femara) and ribociclib was 44% lower than for patients assigned to receive letrozole and placebo, reported Gabriel N. Hortobagyi, MD, of the University of Texas MD Anderson Cancer Center, Houston, on behalf of coinvestigators in the MONALEESA-2 trial.
“We concluded that patients who received ribociclib with letrozole had a statistically significant and a clinically meaningful increase in progress-free survival compared to letrozole plus placebo, or letrozole alone,” he said at the European Society for Medical Oncology Congress.
“Is this a game changer? I think it probably is,” said invited discussant Stephen R.D. Johnston, MD, PhD, professor of breast cancer medicine and consultant oncologist at Royal Marsden Hospital in London.
Results of the first interim analysis of MONALEESA-2 (Mammary Oncology Assessment of LEE011’s Efficacy and Safety) were published simultaneously in the New England Journal of Medicine.
CDK 4 and 6 are frequently overexpressed in hormone receptor–positive breast cancer, and are key mediators of endocrine resistance, Dr. Hortobagyi explained.
Ribociclib is an oral small-molecule inhibitor of the pathway that includes CDK4/6 and the retinoblastoma protein, and has been shown to have efficacy in previously untreated HR-positive advanced breast cancer, and in patients with progressive disease on other therapies.
The MONALEESA-2 study is a phase III, double-blind, placebo-controlled trial of 668 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had not received prior therapy for advanced disease. Patients were stratified by the presence or absence of liver and/or lung metastases, and then assigned to receive letrozole 2.5 mg/day plus either ribociclib 600 mg/day for 3 weeks followed by 1 week off, or placebo on the same schedule.
At a preplanned interim analysis, after 243 events (disease progression or death) had occurred, the investigators found that the trial met its primary endpoint of locally assessed PFS, with a hazard ratio for ribociclib of 0.556 (P = .0000329 for superiority).
At the time of the analysis, median PFS had not been reached in the combination arm, compared with 14.7 months for the letrozole/placebo arm.
At 18 months’ follow-up (median 15.3 months), the PFS rate for ribociclib and letrozole was 63%, compared with 42.2% in the placebo group.
Respective response rates for patients with measurable disease at baseline were 52.7% vs. 37.1% (P less than .001).
Grade 3 or 4 adverse events occurring in more than 10% of patients included neutropenia in nearly two-thirds (59.3%) of the women who received ribociclib vs. 0.9% of those who received placebo, and leukopenia in 21% vs. 0.6%, respectively. In all, 7.5% of patients in the ribociclib group discontinued therapy because of adverse events, compared with 2.1% in the placebo group.
The challenge, Dr. Johnston said, will be to figure out how to integrate the findings from this trial and similar results with the CDK4/6 inhibitor palbociclib and letrozole seen in the PALOMA-2 trial into clinical practice.
Clinicians will be faced with deciding how to select various patient groups – endocrine sensitive, endocrine resistant, and treatment-naive – for targeted combinations or perhaps, for some patients, an aromatase inhibitor alone.
It also remains to be seen whether the CDK4/6 inhibitor/AI combination will be cost effective or affordable in many countries, and the pattern of resistance to CDK 4/6 inhibition is sill unknown, Dr. Johnston said.
The study was funded by Novartis. Dr. Hortobagyi disclosed grants and personal fees from the company during the conduct of the study, and personal fees from Eli Lilly and Pfizer outside the submitted work. Dr. Johnston disclosed consulting and/or research funding with AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Eli Lilly, Roche/Genentech and Puma
COPENHAGEN – Progression-free survival for postmenopausal women with hormone receptor–positive advanced breast cancer was significantly improved when the cyclin-dependent kinase inhibitor ribociclib was added to standard therapy with the aromatase inhibitor letrozole, interim analysis from a phase III randomized trial shows.
After 18 months of follow-up, the risk of progression-free survival (PFS) among patients assigned to receive letrozole (Femara) and ribociclib was 44% lower than for patients assigned to receive letrozole and placebo, reported Gabriel N. Hortobagyi, MD, of the University of Texas MD Anderson Cancer Center, Houston, on behalf of coinvestigators in the MONALEESA-2 trial.
“We concluded that patients who received ribociclib with letrozole had a statistically significant and a clinically meaningful increase in progress-free survival compared to letrozole plus placebo, or letrozole alone,” he said at the European Society for Medical Oncology Congress.
“Is this a game changer? I think it probably is,” said invited discussant Stephen R.D. Johnston, MD, PhD, professor of breast cancer medicine and consultant oncologist at Royal Marsden Hospital in London.
Results of the first interim analysis of MONALEESA-2 (Mammary Oncology Assessment of LEE011’s Efficacy and Safety) were published simultaneously in the New England Journal of Medicine.
CDK 4 and 6 are frequently overexpressed in hormone receptor–positive breast cancer, and are key mediators of endocrine resistance, Dr. Hortobagyi explained.
Ribociclib is an oral small-molecule inhibitor of the pathway that includes CDK4/6 and the retinoblastoma protein, and has been shown to have efficacy in previously untreated HR-positive advanced breast cancer, and in patients with progressive disease on other therapies.
The MONALEESA-2 study is a phase III, double-blind, placebo-controlled trial of 668 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had not received prior therapy for advanced disease. Patients were stratified by the presence or absence of liver and/or lung metastases, and then assigned to receive letrozole 2.5 mg/day plus either ribociclib 600 mg/day for 3 weeks followed by 1 week off, or placebo on the same schedule.
At a preplanned interim analysis, after 243 events (disease progression or death) had occurred, the investigators found that the trial met its primary endpoint of locally assessed PFS, with a hazard ratio for ribociclib of 0.556 (P = .0000329 for superiority).
At the time of the analysis, median PFS had not been reached in the combination arm, compared with 14.7 months for the letrozole/placebo arm.
At 18 months’ follow-up (median 15.3 months), the PFS rate for ribociclib and letrozole was 63%, compared with 42.2% in the placebo group.
Respective response rates for patients with measurable disease at baseline were 52.7% vs. 37.1% (P less than .001).
Grade 3 or 4 adverse events occurring in more than 10% of patients included neutropenia in nearly two-thirds (59.3%) of the women who received ribociclib vs. 0.9% of those who received placebo, and leukopenia in 21% vs. 0.6%, respectively. In all, 7.5% of patients in the ribociclib group discontinued therapy because of adverse events, compared with 2.1% in the placebo group.
The challenge, Dr. Johnston said, will be to figure out how to integrate the findings from this trial and similar results with the CDK4/6 inhibitor palbociclib and letrozole seen in the PALOMA-2 trial into clinical practice.
Clinicians will be faced with deciding how to select various patient groups – endocrine sensitive, endocrine resistant, and treatment-naive – for targeted combinations or perhaps, for some patients, an aromatase inhibitor alone.
It also remains to be seen whether the CDK4/6 inhibitor/AI combination will be cost effective or affordable in many countries, and the pattern of resistance to CDK 4/6 inhibition is sill unknown, Dr. Johnston said.
The study was funded by Novartis. Dr. Hortobagyi disclosed grants and personal fees from the company during the conduct of the study, and personal fees from Eli Lilly and Pfizer outside the submitted work. Dr. Johnston disclosed consulting and/or research funding with AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Eli Lilly, Roche/Genentech and Puma
COPENHAGEN – Progression-free survival for postmenopausal women with hormone receptor–positive advanced breast cancer was significantly improved when the cyclin-dependent kinase inhibitor ribociclib was added to standard therapy with the aromatase inhibitor letrozole, interim analysis from a phase III randomized trial shows.
After 18 months of follow-up, the risk of progression-free survival (PFS) among patients assigned to receive letrozole (Femara) and ribociclib was 44% lower than for patients assigned to receive letrozole and placebo, reported Gabriel N. Hortobagyi, MD, of the University of Texas MD Anderson Cancer Center, Houston, on behalf of coinvestigators in the MONALEESA-2 trial.
“We concluded that patients who received ribociclib with letrozole had a statistically significant and a clinically meaningful increase in progress-free survival compared to letrozole plus placebo, or letrozole alone,” he said at the European Society for Medical Oncology Congress.
“Is this a game changer? I think it probably is,” said invited discussant Stephen R.D. Johnston, MD, PhD, professor of breast cancer medicine and consultant oncologist at Royal Marsden Hospital in London.
Results of the first interim analysis of MONALEESA-2 (Mammary Oncology Assessment of LEE011’s Efficacy and Safety) were published simultaneously in the New England Journal of Medicine.
CDK 4 and 6 are frequently overexpressed in hormone receptor–positive breast cancer, and are key mediators of endocrine resistance, Dr. Hortobagyi explained.
Ribociclib is an oral small-molecule inhibitor of the pathway that includes CDK4/6 and the retinoblastoma protein, and has been shown to have efficacy in previously untreated HR-positive advanced breast cancer, and in patients with progressive disease on other therapies.
The MONALEESA-2 study is a phase III, double-blind, placebo-controlled trial of 668 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had not received prior therapy for advanced disease. Patients were stratified by the presence or absence of liver and/or lung metastases, and then assigned to receive letrozole 2.5 mg/day plus either ribociclib 600 mg/day for 3 weeks followed by 1 week off, or placebo on the same schedule.
At a preplanned interim analysis, after 243 events (disease progression or death) had occurred, the investigators found that the trial met its primary endpoint of locally assessed PFS, with a hazard ratio for ribociclib of 0.556 (P = .0000329 for superiority).
At the time of the analysis, median PFS had not been reached in the combination arm, compared with 14.7 months for the letrozole/placebo arm.
At 18 months’ follow-up (median 15.3 months), the PFS rate for ribociclib and letrozole was 63%, compared with 42.2% in the placebo group.
Respective response rates for patients with measurable disease at baseline were 52.7% vs. 37.1% (P less than .001).
Grade 3 or 4 adverse events occurring in more than 10% of patients included neutropenia in nearly two-thirds (59.3%) of the women who received ribociclib vs. 0.9% of those who received placebo, and leukopenia in 21% vs. 0.6%, respectively. In all, 7.5% of patients in the ribociclib group discontinued therapy because of adverse events, compared with 2.1% in the placebo group.
The challenge, Dr. Johnston said, will be to figure out how to integrate the findings from this trial and similar results with the CDK4/6 inhibitor palbociclib and letrozole seen in the PALOMA-2 trial into clinical practice.
Clinicians will be faced with deciding how to select various patient groups – endocrine sensitive, endocrine resistant, and treatment-naive – for targeted combinations or perhaps, for some patients, an aromatase inhibitor alone.
It also remains to be seen whether the CDK4/6 inhibitor/AI combination will be cost effective or affordable in many countries, and the pattern of resistance to CDK 4/6 inhibition is sill unknown, Dr. Johnston said.
The study was funded by Novartis. Dr. Hortobagyi disclosed grants and personal fees from the company during the conduct of the study, and personal fees from Eli Lilly and Pfizer outside the submitted work. Dr. Johnston disclosed consulting and/or research funding with AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Eli Lilly, Roche/Genentech and Puma
Key clinical point: Adding the CDK 4/6 inhibitor ribociclib to an aromatase inhibitor significantly improved PFS in postmenopausal women with HR+/HER2- advanced breast cancer.
Major finding: The hazard ratio for progression with the combination of ribociclib and letrozole was 0.556 compared with letrozole/placebo.
Data source: Randomized phase III, placebo controlled trial in 668 postmenopausal women with untreated HR-positive/HER2- advanced breast cancer.
Disclosures: The study was funded by Novartis. Dr. Hortobagyi disclosed grants and personal fees from the company during the conduct of the study, and personal fees from Eli Lilly and Pfizer outside the submitted work. Dr. Johnston disclosed consulting and/or research funding with AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Eli Lilly, Roche/Genentech and Puma.
TNF inhibitors’ effect on ankylosing spondylitis progression may be greatest after 6 years
The benefits of treatment with TNF-alpha inhibitors in reducing spinal radiographic progression in ankylosing spondylitis became most evident 6-8 years after the biologic therapy was initiated, according to findings from a prospective observational cohort study.
The study enrolled 210 consecutive patients from the Groningen Leeuwarden AS (GLAS) cohort who initiated treatment with TNF-alpha inhibitors during 2004-2012 and who received baseline and biannual radiographs over the 8-year follow-up.
In patients with complete modified Stoke AS Spine Score (mSASSS) data over 8 years of follow-up, the estimated mean spinal radiographic progression was 2.3 points during the first 2 years of treatment and then declined steadily to 1.4 in years 2-4, 1.0 in years 4-6 and 0.8 in years 6-8. This decrease was seen even after adjusting for baseline mSASSS, the presence of syndesmophytes, sex, HLA-B27 status, age, symptom duration, smoking duration, body mass index, disease activity, and NSAID use.
Patients with longer follow-up also showed more use of NSAIDs, higher C-reactive protein levels, and more spinal radiographic damage at baseline. There were, however, significant improvements in all disease activity measures as soon as patients began treatment, and patients also showed a rapid decrease in NSAID use over time, said Fiona Maas of the University Medical Center Groningen (Netherlands) and her associates.
Multiple studies have been conducted into the impact of TNF-alpha inhibitors on spinal radiographic progression in ankylosing spondylitis, but the results have been subject to some debate, the investigators noted.
“It is known that radiographic progression in AS is overall slow and highly variable between patients,” they wrote. “Therefore, differences in patient numbers at the different time points during follow-up can affect the outcome measure of interest, in this case radiographic progression.”
In this study, researchers saw a straightforward linear progression of disease in the first 4 years after treatment was initiated but a deflection from linear progression in years 6 and 8.
“These results may refer to a delayed effect of TNF-alpha inhibitors on radiographic progression and support the TNF brake hypothesis,” they wrote, suggesting that the long-term inhibition of inflammation with TNF-alpha inhibitors diminishes new bone formation over time in patients with longstanding disease.
The GLAS cohort was supported Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies including Pfizer. No other conflicts of interest were declared.
The benefits of treatment with TNF-alpha inhibitors in reducing spinal radiographic progression in ankylosing spondylitis became most evident 6-8 years after the biologic therapy was initiated, according to findings from a prospective observational cohort study.
The study enrolled 210 consecutive patients from the Groningen Leeuwarden AS (GLAS) cohort who initiated treatment with TNF-alpha inhibitors during 2004-2012 and who received baseline and biannual radiographs over the 8-year follow-up.
In patients with complete modified Stoke AS Spine Score (mSASSS) data over 8 years of follow-up, the estimated mean spinal radiographic progression was 2.3 points during the first 2 years of treatment and then declined steadily to 1.4 in years 2-4, 1.0 in years 4-6 and 0.8 in years 6-8. This decrease was seen even after adjusting for baseline mSASSS, the presence of syndesmophytes, sex, HLA-B27 status, age, symptom duration, smoking duration, body mass index, disease activity, and NSAID use.
Patients with longer follow-up also showed more use of NSAIDs, higher C-reactive protein levels, and more spinal radiographic damage at baseline. There were, however, significant improvements in all disease activity measures as soon as patients began treatment, and patients also showed a rapid decrease in NSAID use over time, said Fiona Maas of the University Medical Center Groningen (Netherlands) and her associates.
Multiple studies have been conducted into the impact of TNF-alpha inhibitors on spinal radiographic progression in ankylosing spondylitis, but the results have been subject to some debate, the investigators noted.
“It is known that radiographic progression in AS is overall slow and highly variable between patients,” they wrote. “Therefore, differences in patient numbers at the different time points during follow-up can affect the outcome measure of interest, in this case radiographic progression.”
In this study, researchers saw a straightforward linear progression of disease in the first 4 years after treatment was initiated but a deflection from linear progression in years 6 and 8.
“These results may refer to a delayed effect of TNF-alpha inhibitors on radiographic progression and support the TNF brake hypothesis,” they wrote, suggesting that the long-term inhibition of inflammation with TNF-alpha inhibitors diminishes new bone formation over time in patients with longstanding disease.
The GLAS cohort was supported Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies including Pfizer. No other conflicts of interest were declared.
The benefits of treatment with TNF-alpha inhibitors in reducing spinal radiographic progression in ankylosing spondylitis became most evident 6-8 years after the biologic therapy was initiated, according to findings from a prospective observational cohort study.
The study enrolled 210 consecutive patients from the Groningen Leeuwarden AS (GLAS) cohort who initiated treatment with TNF-alpha inhibitors during 2004-2012 and who received baseline and biannual radiographs over the 8-year follow-up.
In patients with complete modified Stoke AS Spine Score (mSASSS) data over 8 years of follow-up, the estimated mean spinal radiographic progression was 2.3 points during the first 2 years of treatment and then declined steadily to 1.4 in years 2-4, 1.0 in years 4-6 and 0.8 in years 6-8. This decrease was seen even after adjusting for baseline mSASSS, the presence of syndesmophytes, sex, HLA-B27 status, age, symptom duration, smoking duration, body mass index, disease activity, and NSAID use.
Patients with longer follow-up also showed more use of NSAIDs, higher C-reactive protein levels, and more spinal radiographic damage at baseline. There were, however, significant improvements in all disease activity measures as soon as patients began treatment, and patients also showed a rapid decrease in NSAID use over time, said Fiona Maas of the University Medical Center Groningen (Netherlands) and her associates.
Multiple studies have been conducted into the impact of TNF-alpha inhibitors on spinal radiographic progression in ankylosing spondylitis, but the results have been subject to some debate, the investigators noted.
“It is known that radiographic progression in AS is overall slow and highly variable between patients,” they wrote. “Therefore, differences in patient numbers at the different time points during follow-up can affect the outcome measure of interest, in this case radiographic progression.”
In this study, researchers saw a straightforward linear progression of disease in the first 4 years after treatment was initiated but a deflection from linear progression in years 6 and 8.
“These results may refer to a delayed effect of TNF-alpha inhibitors on radiographic progression and support the TNF brake hypothesis,” they wrote, suggesting that the long-term inhibition of inflammation with TNF-alpha inhibitors diminishes new bone formation over time in patients with longstanding disease.
The GLAS cohort was supported Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies including Pfizer. No other conflicts of interest were declared.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point: The
Major finding: Spinal radiographic progression rates on the modified Stoke AS Spine Score in ankylosing spondylitis patients treated with TNF-alpha inhibitors dropped from 2.3 during the first 2 years of treatment to 0.8 in years 6-8 after treatment initiation.
Data source: The Groningen Leeuwarden AS (GLAS) prospective observational cohort study involving 210 patients with ankylosing spondylitis.
Disclosures: The GLAS cohort was supported by Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies, including Pfizer. No other conflicts of interest were declared.
Birth outcomes unaffected by paternal immunosuppressive therapy
VIENNA – The use of classic systemic immunosuppressive agents by men in the months shortly before conception was not associated with increased risk of low birthweight, preterm birth, or congenital anomalies in their offspring in a large Danish national registry.
“We didn’t see any real safety signals,” Dr. Alexander Egeberg reported at the annual congress of the European Academy of Dermatology and Venereology.
He and his coinvestigators at the University of Copenhagen decided to examine this issue for a simple reason: “We know quite a lot from registry studies about the safety of these drugs when used by women during pregnancy, but very little about the safety of paternal use,” Dr. Egeberg explained.
Methotrexate, azathioprine, and cyclosporine are often prescribed for patients with moderate to severe psoriasis and psoriatic arthritis as well as other chronic inflammatory disorders. Female patients are typically told to stop using these medications if they’re trying to become pregnant, or as soon as they think they might be pregnant, but nearly half of all pregnancies are unintended.
Using linked comprehensive national Danish databases, the investigators scrutinized the medical records of all children born in Denmark during 2004-2010, as well as those of their parents. They identified 2,235 children whose fathers had been on immunosuppressive therapy for a medical condition at any time prior to conception. There were 1,246 fathers who had been on azathioprine, 848 on methotrexate, and 141 on cyclosporine.
Rates of preterm birth, congenital anomalies, and low birthweight were compared in children born to fathers using immunosuppression and in 415,589 children born to fathers with no history of exposure to the medications. These comparisons entailed multivariate regression analyses adjusted for maternal age, parity, smoking status, and the child’s gender. Dr. Egeberg and his colleagues also compared rates of these reproductive complications in the subgroup of children whose fathers had been on the medications within 3 months prior to the estimated time of conception and in children whose fathers had stopped taking the drugs by that point.
None of the adverse neonatal outcomes were significantly increased in ever or recent paternal users of the medications under study, with one exception. Paternal use of cyclosporine within the last 3 months prior to conception was associated with an adjusted 3.7-fold increased likelihood of having a baby with a congenital anomaly. Dr. Egeberg, however, was quick to state that this finding was based on small numbers of exposures: 18 paternal exposures and four affected offspring.
“The cyclosporine finding should be interpreted quite cautiously,” he emphasized.
The reproductive outcomes study was supported by Danish governmental research funds. Dr. Egeberg reported having received research funding from and serving as a consultant to Pfizer and Eli Lilly.
VIENNA – The use of classic systemic immunosuppressive agents by men in the months shortly before conception was not associated with increased risk of low birthweight, preterm birth, or congenital anomalies in their offspring in a large Danish national registry.
“We didn’t see any real safety signals,” Dr. Alexander Egeberg reported at the annual congress of the European Academy of Dermatology and Venereology.
He and his coinvestigators at the University of Copenhagen decided to examine this issue for a simple reason: “We know quite a lot from registry studies about the safety of these drugs when used by women during pregnancy, but very little about the safety of paternal use,” Dr. Egeberg explained.
Methotrexate, azathioprine, and cyclosporine are often prescribed for patients with moderate to severe psoriasis and psoriatic arthritis as well as other chronic inflammatory disorders. Female patients are typically told to stop using these medications if they’re trying to become pregnant, or as soon as they think they might be pregnant, but nearly half of all pregnancies are unintended.
Using linked comprehensive national Danish databases, the investigators scrutinized the medical records of all children born in Denmark during 2004-2010, as well as those of their parents. They identified 2,235 children whose fathers had been on immunosuppressive therapy for a medical condition at any time prior to conception. There were 1,246 fathers who had been on azathioprine, 848 on methotrexate, and 141 on cyclosporine.
Rates of preterm birth, congenital anomalies, and low birthweight were compared in children born to fathers using immunosuppression and in 415,589 children born to fathers with no history of exposure to the medications. These comparisons entailed multivariate regression analyses adjusted for maternal age, parity, smoking status, and the child’s gender. Dr. Egeberg and his colleagues also compared rates of these reproductive complications in the subgroup of children whose fathers had been on the medications within 3 months prior to the estimated time of conception and in children whose fathers had stopped taking the drugs by that point.
None of the adverse neonatal outcomes were significantly increased in ever or recent paternal users of the medications under study, with one exception. Paternal use of cyclosporine within the last 3 months prior to conception was associated with an adjusted 3.7-fold increased likelihood of having a baby with a congenital anomaly. Dr. Egeberg, however, was quick to state that this finding was based on small numbers of exposures: 18 paternal exposures and four affected offspring.
“The cyclosporine finding should be interpreted quite cautiously,” he emphasized.
The reproductive outcomes study was supported by Danish governmental research funds. Dr. Egeberg reported having received research funding from and serving as a consultant to Pfizer and Eli Lilly.
VIENNA – The use of classic systemic immunosuppressive agents by men in the months shortly before conception was not associated with increased risk of low birthweight, preterm birth, or congenital anomalies in their offspring in a large Danish national registry.
“We didn’t see any real safety signals,” Dr. Alexander Egeberg reported at the annual congress of the European Academy of Dermatology and Venereology.
He and his coinvestigators at the University of Copenhagen decided to examine this issue for a simple reason: “We know quite a lot from registry studies about the safety of these drugs when used by women during pregnancy, but very little about the safety of paternal use,” Dr. Egeberg explained.
Methotrexate, azathioprine, and cyclosporine are often prescribed for patients with moderate to severe psoriasis and psoriatic arthritis as well as other chronic inflammatory disorders. Female patients are typically told to stop using these medications if they’re trying to become pregnant, or as soon as they think they might be pregnant, but nearly half of all pregnancies are unintended.
Using linked comprehensive national Danish databases, the investigators scrutinized the medical records of all children born in Denmark during 2004-2010, as well as those of their parents. They identified 2,235 children whose fathers had been on immunosuppressive therapy for a medical condition at any time prior to conception. There were 1,246 fathers who had been on azathioprine, 848 on methotrexate, and 141 on cyclosporine.
Rates of preterm birth, congenital anomalies, and low birthweight were compared in children born to fathers using immunosuppression and in 415,589 children born to fathers with no history of exposure to the medications. These comparisons entailed multivariate regression analyses adjusted for maternal age, parity, smoking status, and the child’s gender. Dr. Egeberg and his colleagues also compared rates of these reproductive complications in the subgroup of children whose fathers had been on the medications within 3 months prior to the estimated time of conception and in children whose fathers had stopped taking the drugs by that point.
None of the adverse neonatal outcomes were significantly increased in ever or recent paternal users of the medications under study, with one exception. Paternal use of cyclosporine within the last 3 months prior to conception was associated with an adjusted 3.7-fold increased likelihood of having a baby with a congenital anomaly. Dr. Egeberg, however, was quick to state that this finding was based on small numbers of exposures: 18 paternal exposures and four affected offspring.
“The cyclosporine finding should be interpreted quite cautiously,” he emphasized.
The reproductive outcomes study was supported by Danish governmental research funds. Dr. Egeberg reported having received research funding from and serving as a consultant to Pfizer and Eli Lilly.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Adjusted rates of congenital anomalies, preterm birth, and low birthweight are not increased in children with paternal use of azathioprine, methotrexate, or cyclosporine prior to conception.
Data source: This retrospective study utilized linked Danish national registries to compare rates of low birthweight, congenital anomalies, and preterm birth in all Danish children born in 2004-2010 depending upon whether or not the father had been on methotrexate, azathioprine, or cyclosporine prior to the pregnancy.
Disclosures: The study was supported by Danish governmental research funds. Dr. Egeberg reported having received research funding from, and serving as a consultant to, Pfizer and Eli Lilly.
VIDEO: DNA-derived Zika vaccine in humans holds promise
BALTIMORE – Hope is high right now for a genetically engineered Zika virus vaccine currently being tested in humans.
“If we saw something, even early on, that we were concerned about, we would stop the trial and re-evaluate it. And that hasn’t happened, so that’s good news,” said Kathleen M. Neuzil, MD, lead investigator of the trial and a professor at the University of Maryland in Baltimore, where she is also director of the Center for Vaccine Development.
Testing of the DNA-based Zika vaccine began in early August. Now that Congress has approved a $1.1 billion funding package, Dr. Neuzil said investigators can rest assured that there is enough funding for the duration of this trial, which ultimately could take 2 years or longer.
Sponsored by the National Institutes of Health, phase I of the trial is being conducted at three U.S. sites, including the University of Maryland’s Vaccine Development Center, the NIH Clinical Center in Bethesda, Md., and Emory University in Atlanta.
Safety and tolerability results from all three sites are expected by year’s end and will inform how to construct phase II, currently set to begin in early 2017. That phase is expected to include a much larger population than the 80 current participants, although the exact numbers are still to be determined, Dr. Neuzil said. Also still unknown is whether phase II will be conducted internationally.
If the vaccine proves effective, it will be a high point in the annals of maternal-fetal medicine, said Christopher Harman, MD, chair of obstetrics and gynecology and director of the division of maternal-fetal medicine at the University of Maryland. “It’s going to become a story where the power of modern medicine has defeated an epidemic that had enormous potential for harm.”
Dr. Harman also predicted that a viable vaccine, combined with infectious disease prevention services globally, will mitigate Zika’s threat to the population, particularly developing fetuses.
In the meantime, there needs to be continued public education about preventing the spread of Zika, as well as rigorous attention to family planning, Dr. Harman said.
“Planned pregnancy is essential,” he said. “This puts the burden on the couple or the woman. Don’t get pregnant if you’re in an endemic area.”
For more about the vaccine trial and how clinicians can counsel patients about the threat of Zika, watch this video recorded at the University of Maryland.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
BALTIMORE – Hope is high right now for a genetically engineered Zika virus vaccine currently being tested in humans.
“If we saw something, even early on, that we were concerned about, we would stop the trial and re-evaluate it. And that hasn’t happened, so that’s good news,” said Kathleen M. Neuzil, MD, lead investigator of the trial and a professor at the University of Maryland in Baltimore, where she is also director of the Center for Vaccine Development.
Testing of the DNA-based Zika vaccine began in early August. Now that Congress has approved a $1.1 billion funding package, Dr. Neuzil said investigators can rest assured that there is enough funding for the duration of this trial, which ultimately could take 2 years or longer.
Sponsored by the National Institutes of Health, phase I of the trial is being conducted at three U.S. sites, including the University of Maryland’s Vaccine Development Center, the NIH Clinical Center in Bethesda, Md., and Emory University in Atlanta.
Safety and tolerability results from all three sites are expected by year’s end and will inform how to construct phase II, currently set to begin in early 2017. That phase is expected to include a much larger population than the 80 current participants, although the exact numbers are still to be determined, Dr. Neuzil said. Also still unknown is whether phase II will be conducted internationally.
If the vaccine proves effective, it will be a high point in the annals of maternal-fetal medicine, said Christopher Harman, MD, chair of obstetrics and gynecology and director of the division of maternal-fetal medicine at the University of Maryland. “It’s going to become a story where the power of modern medicine has defeated an epidemic that had enormous potential for harm.”
Dr. Harman also predicted that a viable vaccine, combined with infectious disease prevention services globally, will mitigate Zika’s threat to the population, particularly developing fetuses.
In the meantime, there needs to be continued public education about preventing the spread of Zika, as well as rigorous attention to family planning, Dr. Harman said.
“Planned pregnancy is essential,” he said. “This puts the burden on the couple or the woman. Don’t get pregnant if you’re in an endemic area.”
For more about the vaccine trial and how clinicians can counsel patients about the threat of Zika, watch this video recorded at the University of Maryland.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
BALTIMORE – Hope is high right now for a genetically engineered Zika virus vaccine currently being tested in humans.
“If we saw something, even early on, that we were concerned about, we would stop the trial and re-evaluate it. And that hasn’t happened, so that’s good news,” said Kathleen M. Neuzil, MD, lead investigator of the trial and a professor at the University of Maryland in Baltimore, where she is also director of the Center for Vaccine Development.
Testing of the DNA-based Zika vaccine began in early August. Now that Congress has approved a $1.1 billion funding package, Dr. Neuzil said investigators can rest assured that there is enough funding for the duration of this trial, which ultimately could take 2 years or longer.
Sponsored by the National Institutes of Health, phase I of the trial is being conducted at three U.S. sites, including the University of Maryland’s Vaccine Development Center, the NIH Clinical Center in Bethesda, Md., and Emory University in Atlanta.
Safety and tolerability results from all three sites are expected by year’s end and will inform how to construct phase II, currently set to begin in early 2017. That phase is expected to include a much larger population than the 80 current participants, although the exact numbers are still to be determined, Dr. Neuzil said. Also still unknown is whether phase II will be conducted internationally.
If the vaccine proves effective, it will be a high point in the annals of maternal-fetal medicine, said Christopher Harman, MD, chair of obstetrics and gynecology and director of the division of maternal-fetal medicine at the University of Maryland. “It’s going to become a story where the power of modern medicine has defeated an epidemic that had enormous potential for harm.”
Dr. Harman also predicted that a viable vaccine, combined with infectious disease prevention services globally, will mitigate Zika’s threat to the population, particularly developing fetuses.
In the meantime, there needs to be continued public education about preventing the spread of Zika, as well as rigorous attention to family planning, Dr. Harman said.
“Planned pregnancy is essential,” he said. “This puts the burden on the couple or the woman. Don’t get pregnant if you’re in an endemic area.”
For more about the vaccine trial and how clinicians can counsel patients about the threat of Zika, watch this video recorded at the University of Maryland.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
Cord blood product granted breakthrough designation
Photo courtesy of NHS
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for NiCord®, a product in development as a graft modality for patients undergoing hematopoietic stem cell transplant to treat high-risk hematologic malignancies.
NiCord consists of cells from a single unit of umbilical cord blood cultured in nicotinamide (a vitamin B derivative) and cytokines that are typically used for expansion (thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor).
Data from the pilot and phase 1/2 studies of NiCord have suggested the therapy can provide a clinically meaningful improvement in time to neutrophil engraftment over traditional cord blood transplant.
Additional research presented at EBMT 2016 showed that patients who received NiCord had fewer infections, shorter hospital stays, quicker platelet engraftment, and improved non-relapse mortality when compared to patients who received a traditional cord blood transplant.
The phase 3 registration study of NiCord is scheduled to begin before the end of this year.
In addition to breakthrough designation, NiCord also has orphan designation from the FDA as a treatment for patients with acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, or myelodysplastic syndromes.
NiCord is being developed by Gamida Cell.
About breakthrough designation
The FDA’s breakthrough designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.
To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Photo courtesy of NHS
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for NiCord®, a product in development as a graft modality for patients undergoing hematopoietic stem cell transplant to treat high-risk hematologic malignancies.
NiCord consists of cells from a single unit of umbilical cord blood cultured in nicotinamide (a vitamin B derivative) and cytokines that are typically used for expansion (thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor).
Data from the pilot and phase 1/2 studies of NiCord have suggested the therapy can provide a clinically meaningful improvement in time to neutrophil engraftment over traditional cord blood transplant.
Additional research presented at EBMT 2016 showed that patients who received NiCord had fewer infections, shorter hospital stays, quicker platelet engraftment, and improved non-relapse mortality when compared to patients who received a traditional cord blood transplant.
The phase 3 registration study of NiCord is scheduled to begin before the end of this year.
In addition to breakthrough designation, NiCord also has orphan designation from the FDA as a treatment for patients with acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, or myelodysplastic syndromes.
NiCord is being developed by Gamida Cell.
About breakthrough designation
The FDA’s breakthrough designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.
To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Photo courtesy of NHS
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for NiCord®, a product in development as a graft modality for patients undergoing hematopoietic stem cell transplant to treat high-risk hematologic malignancies.
NiCord consists of cells from a single unit of umbilical cord blood cultured in nicotinamide (a vitamin B derivative) and cytokines that are typically used for expansion (thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor).
Data from the pilot and phase 1/2 studies of NiCord have suggested the therapy can provide a clinically meaningful improvement in time to neutrophil engraftment over traditional cord blood transplant.
Additional research presented at EBMT 2016 showed that patients who received NiCord had fewer infections, shorter hospital stays, quicker platelet engraftment, and improved non-relapse mortality when compared to patients who received a traditional cord blood transplant.
The phase 3 registration study of NiCord is scheduled to begin before the end of this year.
In addition to breakthrough designation, NiCord also has orphan designation from the FDA as a treatment for patients with acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, or myelodysplastic syndromes.
NiCord is being developed by Gamida Cell.
About breakthrough designation
The FDA’s breakthrough designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.
To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Surveys Are Not the Most Effective Way to Improve Patient Satisfaction
What started with a car dealership survey has become a near avalanche of surveys from my credit card, bank, airlines, hotels, and other businesses. Each starts by assuring me that it will take only a minute or two to complete the survey, but if I completed every survey sent my way, it would add up to a significant amount of time. So I’ve stopped responding to nearly all of them, not so much as a form of protest but as part of my overall time-management efforts.
I imagine many of our patients see surveys from hospitals and other healthcare providers similarly: just another one to add to the pile. Patients in their 80s and 90s—a significant portion of hospitalist patients—probably interact a lot less with companies that send satisfaction surveys and so might be more attentive to ones from healthcare organizations. But I suspect that a reasonable portion of older patients rely on a family member to complete them, and this person, often a son or daughter, probably does get a lot of similar surveys. Surely, survey fatigue is influencing the results at least a little.
Healthcare Surveys: HCAHPS
For all the surveying going on, I find it pretty difficult to use HCAHPS results to guide patient-satisfaction improvement efforts. Sure, I can see how individual doctors or different physician groups score compared to one another and try to model my behaviors after the high performers. That is a really valuable thing to do, but it doesn’t get to the granular level I’d like.
One would hope the three physician-specific HCAHPS questions would support drilling down to more actionable information. But every hospitalist group I’ve seen always has the same pattern, scoring from lowest to highest as follows:
- How often did doctors explain things in a way you could understand?
- How often did doctors listen carefully to you?
- How often did doctors treat you with courtesy and respect?
So I don’t think the difference in scores on these questions is very useful in guiding improvement efforts.
Looking beyond HCAHPS
For a few years, our hospitalist group added a very short survey to the brochure describing the practice. I still think that was good idea to ensure accurate attribution and more granular information, but it didn’t yield much value in practice because of a low response rate. Ultimately, we stopped using it because of our hospital risk manager’s concern any such survey could be construed as “coaching” patients in their HCAHPS responses, something the Centers for Medicare & Medicaid Services forbids.
Mark Rudolph, MD, vice president of physician development and patient experience at Sound Physicians, told me about their experience with their employed RNs using tablet computers to survey every patient the day following hospital admission (i.e., while patients were still in the hospital). It seems to me this could be a really valuable tool to provide very granular feedback at the outset of a patient stay when there is still time to address areas in which the patient is less satisfied. They found that for about 30% of patients, the survey uncovered something that could be fixed, such as providing another blanket, determining what time a test was likely to be done, etc. I bet for most patients the fact that a nurse cared enough to ask how things are going and try to remedy problems improved their HCAPHS scores.
Yet after some experience with this approach, Sound Physicians found that, for a number of reasons, this wasn’t as valuable as hoped. They now survey a smaller sample of patients and sometimes adjust the questions based on the known or suspected strengths and weaknesses of individual providers. For one doctor, for example, the survey might ask whether the doctor spent enough time with the patient; for another, it might ask if the doctor spoke clearly, etc.
Dr. Rudolph thinks having someone such as the lead hospitalist observe the doctor while on rounds might ultimately prove more valuable than administering a survey. It will be interesting to see how his group and others around the country evolve their approach to better understand each provider’s strengths and weaknesses and most effective ways to improve patient satisfaction.
How to Improve Patient Satisfaction?
In my April 2012 column, I wrote about several things for hospitalists to consider including in their patient-satisfaction improvement plan. And, of course, there are a lot of additional sources of ideas available just by searching the Internet.
I find it difficult to consistently implement a bundle of multiple different habits, such as always sitting or always rounding with the patient’s bedside nurse, etc. I acknowledge these are proven valuable strategies to improve scores, but I still find it hard to do them consistently.
For some of us, it might be better to pick one thing to focus on. And while I don’t have research data to prove it, I think the single most valuable thing to improve patient satisfaction with hospitalists is to phone patients after discharge. It isn’t as difficult as most assume, and it often leads patients (or the family member you reach) to thank you profusely for the call. I think hospitalists can really benefit from more expressions of gratitude from patients and families, and these calls often provide it.
I’ve learned a few lessons about making post-discharge calls that are detailed in my August 2012 column. TH
What started with a car dealership survey has become a near avalanche of surveys from my credit card, bank, airlines, hotels, and other businesses. Each starts by assuring me that it will take only a minute or two to complete the survey, but if I completed every survey sent my way, it would add up to a significant amount of time. So I’ve stopped responding to nearly all of them, not so much as a form of protest but as part of my overall time-management efforts.
I imagine many of our patients see surveys from hospitals and other healthcare providers similarly: just another one to add to the pile. Patients in their 80s and 90s—a significant portion of hospitalist patients—probably interact a lot less with companies that send satisfaction surveys and so might be more attentive to ones from healthcare organizations. But I suspect that a reasonable portion of older patients rely on a family member to complete them, and this person, often a son or daughter, probably does get a lot of similar surveys. Surely, survey fatigue is influencing the results at least a little.
Healthcare Surveys: HCAHPS
For all the surveying going on, I find it pretty difficult to use HCAHPS results to guide patient-satisfaction improvement efforts. Sure, I can see how individual doctors or different physician groups score compared to one another and try to model my behaviors after the high performers. That is a really valuable thing to do, but it doesn’t get to the granular level I’d like.
One would hope the three physician-specific HCAHPS questions would support drilling down to more actionable information. But every hospitalist group I’ve seen always has the same pattern, scoring from lowest to highest as follows:
- How often did doctors explain things in a way you could understand?
- How often did doctors listen carefully to you?
- How often did doctors treat you with courtesy and respect?
So I don’t think the difference in scores on these questions is very useful in guiding improvement efforts.
Looking beyond HCAHPS
For a few years, our hospitalist group added a very short survey to the brochure describing the practice. I still think that was good idea to ensure accurate attribution and more granular information, but it didn’t yield much value in practice because of a low response rate. Ultimately, we stopped using it because of our hospital risk manager’s concern any such survey could be construed as “coaching” patients in their HCAHPS responses, something the Centers for Medicare & Medicaid Services forbids.
Mark Rudolph, MD, vice president of physician development and patient experience at Sound Physicians, told me about their experience with their employed RNs using tablet computers to survey every patient the day following hospital admission (i.e., while patients were still in the hospital). It seems to me this could be a really valuable tool to provide very granular feedback at the outset of a patient stay when there is still time to address areas in which the patient is less satisfied. They found that for about 30% of patients, the survey uncovered something that could be fixed, such as providing another blanket, determining what time a test was likely to be done, etc. I bet for most patients the fact that a nurse cared enough to ask how things are going and try to remedy problems improved their HCAPHS scores.
Yet after some experience with this approach, Sound Physicians found that, for a number of reasons, this wasn’t as valuable as hoped. They now survey a smaller sample of patients and sometimes adjust the questions based on the known or suspected strengths and weaknesses of individual providers. For one doctor, for example, the survey might ask whether the doctor spent enough time with the patient; for another, it might ask if the doctor spoke clearly, etc.
Dr. Rudolph thinks having someone such as the lead hospitalist observe the doctor while on rounds might ultimately prove more valuable than administering a survey. It will be interesting to see how his group and others around the country evolve their approach to better understand each provider’s strengths and weaknesses and most effective ways to improve patient satisfaction.
How to Improve Patient Satisfaction?
In my April 2012 column, I wrote about several things for hospitalists to consider including in their patient-satisfaction improvement plan. And, of course, there are a lot of additional sources of ideas available just by searching the Internet.
I find it difficult to consistently implement a bundle of multiple different habits, such as always sitting or always rounding with the patient’s bedside nurse, etc. I acknowledge these are proven valuable strategies to improve scores, but I still find it hard to do them consistently.
For some of us, it might be better to pick one thing to focus on. And while I don’t have research data to prove it, I think the single most valuable thing to improve patient satisfaction with hospitalists is to phone patients after discharge. It isn’t as difficult as most assume, and it often leads patients (or the family member you reach) to thank you profusely for the call. I think hospitalists can really benefit from more expressions of gratitude from patients and families, and these calls often provide it.
I’ve learned a few lessons about making post-discharge calls that are detailed in my August 2012 column. TH
What started with a car dealership survey has become a near avalanche of surveys from my credit card, bank, airlines, hotels, and other businesses. Each starts by assuring me that it will take only a minute or two to complete the survey, but if I completed every survey sent my way, it would add up to a significant amount of time. So I’ve stopped responding to nearly all of them, not so much as a form of protest but as part of my overall time-management efforts.
I imagine many of our patients see surveys from hospitals and other healthcare providers similarly: just another one to add to the pile. Patients in their 80s and 90s—a significant portion of hospitalist patients—probably interact a lot less with companies that send satisfaction surveys and so might be more attentive to ones from healthcare organizations. But I suspect that a reasonable portion of older patients rely on a family member to complete them, and this person, often a son or daughter, probably does get a lot of similar surveys. Surely, survey fatigue is influencing the results at least a little.
Healthcare Surveys: HCAHPS
For all the surveying going on, I find it pretty difficult to use HCAHPS results to guide patient-satisfaction improvement efforts. Sure, I can see how individual doctors or different physician groups score compared to one another and try to model my behaviors after the high performers. That is a really valuable thing to do, but it doesn’t get to the granular level I’d like.
One would hope the three physician-specific HCAHPS questions would support drilling down to more actionable information. But every hospitalist group I’ve seen always has the same pattern, scoring from lowest to highest as follows:
- How often did doctors explain things in a way you could understand?
- How often did doctors listen carefully to you?
- How often did doctors treat you with courtesy and respect?
So I don’t think the difference in scores on these questions is very useful in guiding improvement efforts.
Looking beyond HCAHPS
For a few years, our hospitalist group added a very short survey to the brochure describing the practice. I still think that was good idea to ensure accurate attribution and more granular information, but it didn’t yield much value in practice because of a low response rate. Ultimately, we stopped using it because of our hospital risk manager’s concern any such survey could be construed as “coaching” patients in their HCAHPS responses, something the Centers for Medicare & Medicaid Services forbids.
Mark Rudolph, MD, vice president of physician development and patient experience at Sound Physicians, told me about their experience with their employed RNs using tablet computers to survey every patient the day following hospital admission (i.e., while patients were still in the hospital). It seems to me this could be a really valuable tool to provide very granular feedback at the outset of a patient stay when there is still time to address areas in which the patient is less satisfied. They found that for about 30% of patients, the survey uncovered something that could be fixed, such as providing another blanket, determining what time a test was likely to be done, etc. I bet for most patients the fact that a nurse cared enough to ask how things are going and try to remedy problems improved their HCAPHS scores.
Yet after some experience with this approach, Sound Physicians found that, for a number of reasons, this wasn’t as valuable as hoped. They now survey a smaller sample of patients and sometimes adjust the questions based on the known or suspected strengths and weaknesses of individual providers. For one doctor, for example, the survey might ask whether the doctor spent enough time with the patient; for another, it might ask if the doctor spoke clearly, etc.
Dr. Rudolph thinks having someone such as the lead hospitalist observe the doctor while on rounds might ultimately prove more valuable than administering a survey. It will be interesting to see how his group and others around the country evolve their approach to better understand each provider’s strengths and weaknesses and most effective ways to improve patient satisfaction.
How to Improve Patient Satisfaction?
In my April 2012 column, I wrote about several things for hospitalists to consider including in their patient-satisfaction improvement plan. And, of course, there are a lot of additional sources of ideas available just by searching the Internet.
I find it difficult to consistently implement a bundle of multiple different habits, such as always sitting or always rounding with the patient’s bedside nurse, etc. I acknowledge these are proven valuable strategies to improve scores, but I still find it hard to do them consistently.
For some of us, it might be better to pick one thing to focus on. And while I don’t have research data to prove it, I think the single most valuable thing to improve patient satisfaction with hospitalists is to phone patients after discharge. It isn’t as difficult as most assume, and it often leads patients (or the family member you reach) to thank you profusely for the call. I think hospitalists can really benefit from more expressions of gratitude from patients and families, and these calls often provide it.
I’ve learned a few lessons about making post-discharge calls that are detailed in my August 2012 column. TH
Bovine heparin may be comparable to porcine heparin
A new study suggests that heparin derived from cattle may be as effective as heparin derived from pigs, but more research is needed.
Investigators found differences in the structural and molecular characteristics of bovine and porcine heparins, but these differences did not appear to have a significant effect on the drugs’ anticoagulant properties in vitro.
Still, the researchers said it is not clear if these differences affect the drugs’ activity in humans.
Jawed Fareed, PhD, of Loyola University Chicago Stritch School of Medicine in Illinois, and his colleagues conducted this research and reported the results in Clinical and Applied Thrombosis/Hemostasis.
Heparin used in the US now comes from the intestines of pigs that are slaughtered for meat. Seventy-five percent of the heparin used in the US comes from China, which is the world’s largest pork producer.
As heparin is a widely used drug that, in certain cases, has no medical alternatives, the US healthcare system could be vulnerable to fluctuations in the crude heparin supply, according to the US Food and Drug Administration’s Center for Drug Evaluation and Research.
Therefore, the center is evaluating reintroducing bovine heparin to the market in order to avoid shortages, particularly in case the porcine heparin supply is contaminated, as occurred in 2008.
Bovine heparin was voluntarily withdrawn from the market during the 1980s due to worries that it could, in rare cases, cause thrombocytopenia or be contaminated with bovine spongiform encephalopathy (mad cow disease).
According to Dr Fareed, those fears have been put to rest by advancements in manufacturing and quality control that have resulted in purer forms of heparin. Still, some experts remain skeptical about bovine heparin.
With this in mind, Dr Fareed and his colleagues compared individually manufactured batches of bovine heparin (historical samples from a variety of manufacturers) with individually manufactured batches of porcine heparin (current samples from 2 different manufacturers).
The investigators studied heparins isolated from pig intestines (PI), bovine lungs (BL), and bovine intestines (BI).
They found the BL, BI, and PI heparins all produced a concentration-dependent anticoagulant effect. And there was no significant difference in the anti-Xa and anti-IIa potencies of the BL, BI, and PI heparins.
The researchers noted that there were significant structural differences between PI and BI heparins, and it isn’t clear whether these differences would have an impact in patients.
Likewise, although the BL heparin samples were “highly similar” to the PI heparin samples, the BL heparins had a lower molecular weight. And the investigators said it was unclear if this would adversely affect the BL heparins’ pharmacology.
Furthermore, the researchers noted that there was greater variability among the BL heparins than the PI heparins. However, they said this could be due to the multiple historic manufacturers of BL heparins.
The investigators concluded that more research is needed to examine these possibilities.
A new study suggests that heparin derived from cattle may be as effective as heparin derived from pigs, but more research is needed.
Investigators found differences in the structural and molecular characteristics of bovine and porcine heparins, but these differences did not appear to have a significant effect on the drugs’ anticoagulant properties in vitro.
Still, the researchers said it is not clear if these differences affect the drugs’ activity in humans.
Jawed Fareed, PhD, of Loyola University Chicago Stritch School of Medicine in Illinois, and his colleagues conducted this research and reported the results in Clinical and Applied Thrombosis/Hemostasis.
Heparin used in the US now comes from the intestines of pigs that are slaughtered for meat. Seventy-five percent of the heparin used in the US comes from China, which is the world’s largest pork producer.
As heparin is a widely used drug that, in certain cases, has no medical alternatives, the US healthcare system could be vulnerable to fluctuations in the crude heparin supply, according to the US Food and Drug Administration’s Center for Drug Evaluation and Research.
Therefore, the center is evaluating reintroducing bovine heparin to the market in order to avoid shortages, particularly in case the porcine heparin supply is contaminated, as occurred in 2008.
Bovine heparin was voluntarily withdrawn from the market during the 1980s due to worries that it could, in rare cases, cause thrombocytopenia or be contaminated with bovine spongiform encephalopathy (mad cow disease).
According to Dr Fareed, those fears have been put to rest by advancements in manufacturing and quality control that have resulted in purer forms of heparin. Still, some experts remain skeptical about bovine heparin.
With this in mind, Dr Fareed and his colleagues compared individually manufactured batches of bovine heparin (historical samples from a variety of manufacturers) with individually manufactured batches of porcine heparin (current samples from 2 different manufacturers).
The investigators studied heparins isolated from pig intestines (PI), bovine lungs (BL), and bovine intestines (BI).
They found the BL, BI, and PI heparins all produced a concentration-dependent anticoagulant effect. And there was no significant difference in the anti-Xa and anti-IIa potencies of the BL, BI, and PI heparins.
The researchers noted that there were significant structural differences between PI and BI heparins, and it isn’t clear whether these differences would have an impact in patients.
Likewise, although the BL heparin samples were “highly similar” to the PI heparin samples, the BL heparins had a lower molecular weight. And the investigators said it was unclear if this would adversely affect the BL heparins’ pharmacology.
Furthermore, the researchers noted that there was greater variability among the BL heparins than the PI heparins. However, they said this could be due to the multiple historic manufacturers of BL heparins.
The investigators concluded that more research is needed to examine these possibilities.
A new study suggests that heparin derived from cattle may be as effective as heparin derived from pigs, but more research is needed.
Investigators found differences in the structural and molecular characteristics of bovine and porcine heparins, but these differences did not appear to have a significant effect on the drugs’ anticoagulant properties in vitro.
Still, the researchers said it is not clear if these differences affect the drugs’ activity in humans.
Jawed Fareed, PhD, of Loyola University Chicago Stritch School of Medicine in Illinois, and his colleagues conducted this research and reported the results in Clinical and Applied Thrombosis/Hemostasis.
Heparin used in the US now comes from the intestines of pigs that are slaughtered for meat. Seventy-five percent of the heparin used in the US comes from China, which is the world’s largest pork producer.
As heparin is a widely used drug that, in certain cases, has no medical alternatives, the US healthcare system could be vulnerable to fluctuations in the crude heparin supply, according to the US Food and Drug Administration’s Center for Drug Evaluation and Research.
Therefore, the center is evaluating reintroducing bovine heparin to the market in order to avoid shortages, particularly in case the porcine heparin supply is contaminated, as occurred in 2008.
Bovine heparin was voluntarily withdrawn from the market during the 1980s due to worries that it could, in rare cases, cause thrombocytopenia or be contaminated with bovine spongiform encephalopathy (mad cow disease).
According to Dr Fareed, those fears have been put to rest by advancements in manufacturing and quality control that have resulted in purer forms of heparin. Still, some experts remain skeptical about bovine heparin.
With this in mind, Dr Fareed and his colleagues compared individually manufactured batches of bovine heparin (historical samples from a variety of manufacturers) with individually manufactured batches of porcine heparin (current samples from 2 different manufacturers).
The investigators studied heparins isolated from pig intestines (PI), bovine lungs (BL), and bovine intestines (BI).
They found the BL, BI, and PI heparins all produced a concentration-dependent anticoagulant effect. And there was no significant difference in the anti-Xa and anti-IIa potencies of the BL, BI, and PI heparins.
The researchers noted that there were significant structural differences between PI and BI heparins, and it isn’t clear whether these differences would have an impact in patients.
Likewise, although the BL heparin samples were “highly similar” to the PI heparin samples, the BL heparins had a lower molecular weight. And the investigators said it was unclear if this would adversely affect the BL heparins’ pharmacology.
Furthermore, the researchers noted that there was greater variability among the BL heparins than the PI heparins. However, they said this could be due to the multiple historic manufacturers of BL heparins.
The investigators concluded that more research is needed to examine these possibilities.