General Surgery

In patients with indeterminate thyroid nodules, routine gene expression classifier testing may not meet standard definitions of cost efficacy relative to conventional care at many treatment centers, according to a decision-tree analysis performed with data from a tertiary treatment center.

In this analysis, gene expression classifier (GEC) testing was associated with a small gain in health benefits, measured in quality adjusted life-years (QALY), but at a much higher cost than conventional care, according to Dr. James X. Wu of the University of California, Los Angeles. The data were presented at the annual meeting of the American Association of Endocrine Surgeons (AAES).

Management of thyroid nodules indeterminate for malignancy after fine needle aspiration, which occurs in up to 30% of patients, is a challenge, according to Dr. Wu. Cancer rates in these patients can be as high as 30%, and often benign and malignant indeterminate nodules are indistinguishable. Conventionally, surgical resection is recommended to avoid missing a cancer diagnosis. However, uniform thyroid lobectomy means that 70% or more of lesions excised will be benign.

GEC testing is a relatively new molecular test that helps guide therapy in these individuals. The high negative predictive value of this test allows the test to reliably predict when patients have benign disease, giving them the option of being observed rather than undergoing surgery, explained Dr. Wu. In this study, the goal was to determine whether GEC testing has the potential to be cost effective, defined as a ratio of added cost to QALYs gained of less than $100,000/QALY relative to conventional treatment.

The decision-tree model was constructed on 2 years of GEC testing performance data prospectively collected at UCLA. In this model, the assumption was made that patients would be observed if the GEC test was negative but would undergo thyroid resection if the gene expression classifier test was suspicious.

Applying the UCLA dataset to the model, the expected cost for conventional management in the reference scenario was $11,119 to produce 22.15 QALYs, according to Dr. Wu. Routine GEC testing produced an additional 0.01 QALY but cost $1,197 more. This translated into an incremental cost-effectiveness ratio of $119,700/QALY, which exceeded the common $100,000/QALY threshold for cost efficacy.

The main determinants of cost effectiveness were the cost of the gene expression classifier test, the rate of malignancy in patients with indeterminate thyroid nodules, and cost of thyroid lobectomy.

More favorable costs for gene expression testing could be generated by plausible alterations of key clinical factors. This included lowering the cost of the GEC test itself or raising the cost of thyroid lobectomy. For example, the GEC testing became cost effective with the parameters used if the test was less than $2,460 or the cost of thyroid lobectomy exceeded $12,160.

In addition, malignancy rates influenced the relative cost efficacy of gene expression classifier testing. Centers with lower rates of cancer get more value from routine GEC testing than do centers with high rates of cancer, because more patients avoid surgery with testing. At UCLA, the malignancy rate was 24%, and could pay as much as $2,460 per test to remain cost-effective. Institutions with a malignancy rate less than 24% would have a higher cost threshold.

Indeed, even though routine gene expression classifier testing was not found to be cost effective using the assumptions of this study and data from UCLA, on probabilistic sensitivity analysis, it was found to be cost effective in 53.2% of simulations. Dr. Wu suggested the same analyses should be performed at centers using their own data to accurately assess cost effectiveness. Given the wide variation in important variables, particularly the malignancy rate in indeterminate nodules, the results from one institution cannot reliably predict the cost effectiveness at a separate treatment facility.

“Our conclusion is that every center needs to audit themselves to find out whether it’s truly cost effective and not blindly trust that it’s 100% cost effective across the board.” Dr. Wu reported. He noted that gene expression classifier testing, which has been used for 2 years at UCLA, is likely to be continued to be used but with a focus on making the test more cost effective by finding ways to use it more selectively.

In patients with indeterminate thyroid nodules, routine gene expression classifier testing may not meet standard definitions of cost efficacy relative to conventional care at many treatment centers, according to a decision-tree analysis performed with data from a tertiary treatment center.

In this analysis, gene expression classifier (GEC) testing was associated with a small gain in health benefits, measured in quality adjusted life-years (QALY), but at a much higher cost than conventional care, according to Dr. James X. Wu of the University of California, Los Angeles. The data were presented at the annual meeting of the American Association of Endocrine Surgeons (AAES).

Management of thyroid nodules indeterminate for malignancy after fine needle aspiration, which occurs in up to 30% of patients, is a challenge, according to Dr. Wu. Cancer rates in these patients can be as high as 30%, and often benign and malignant indeterminate nodules are indistinguishable. Conventionally, surgical resection is recommended to avoid missing a cancer diagnosis. However, uniform thyroid lobectomy means that 70% or more of lesions excised will be benign.

GEC testing is a relatively new molecular test that helps guide therapy in these individuals. The high negative predictive value of this test allows the test to reliably predict when patients have benign disease, giving them the option of being observed rather than undergoing surgery, explained Dr. Wu. In this study, the goal was to determine whether GEC testing has the potential to be cost effective, defined as a ratio of added cost to QALYs gained of less than $100,000/QALY relative to conventional treatment.

The decision-tree model was constructed on 2 years of GEC testing performance data prospectively collected at UCLA. In this model, the assumption was made that patients would be observed if the GEC test was negative but would undergo thyroid resection if the gene expression classifier test was suspicious.

Applying the UCLA dataset to the model, the expected cost for conventional management in the reference scenario was $11,119 to produce 22.15 QALYs, according to Dr. Wu. Routine GEC testing produced an additional 0.01 QALY but cost $1,197 more. This translated into an incremental cost-effectiveness ratio of $119,700/QALY, which exceeded the common $100,000/QALY threshold for cost efficacy.

The main determinants of cost effectiveness were the cost of the gene expression classifier test, the rate of malignancy in patients with indeterminate thyroid nodules, and cost of thyroid lobectomy.

More favorable costs for gene expression testing could be generated by plausible alterations of key clinical factors. This included lowering the cost of the GEC test itself or raising the cost of thyroid lobectomy. For example, the GEC testing became cost effective with the parameters used if the test was less than $2,460 or the cost of thyroid lobectomy exceeded $12,160.

In addition, malignancy rates influenced the relative cost efficacy of gene expression classifier testing. Centers with lower rates of cancer get more value from routine GEC testing than do centers with high rates of cancer, because more patients avoid surgery with testing. At UCLA, the malignancy rate was 24%, and could pay as much as $2,460 per test to remain cost-effective. Institutions with a malignancy rate less than 24% would have a higher cost threshold.

Indeed, even though routine gene expression classifier testing was not found to be cost effective using the assumptions of this study and data from UCLA, on probabilistic sensitivity analysis, it was found to be cost effective in 53.2% of simulations. Dr. Wu suggested the same analyses should be performed at centers using their own data to accurately assess cost effectiveness. Given the wide variation in important variables, particularly the malignancy rate in indeterminate nodules, the results from one institution cannot reliably predict the cost effectiveness at a separate treatment facility.

“Our conclusion is that every center needs to audit themselves to find out whether it’s truly cost effective and not blindly trust that it’s 100% cost effective across the board.” Dr. Wu reported. He noted that gene expression classifier testing, which has been used for 2 years at UCLA, is likely to be continued to be used but with a focus on making the test more cost effective by finding ways to use it more selectively.

In patients with indeterminate thyroid nodules, routine gene expression classifier testing may not meet standard definitions of cost efficacy relative to conventional care at many treatment centers, according to a decision-tree analysis performed with data from a tertiary treatment center.

In this analysis, gene expression classifier (GEC) testing was associated with a small gain in health benefits, measured in quality adjusted life-years (QALY), but at a much higher cost than conventional care, according to Dr. James X. Wu of the University of California, Los Angeles. The data were presented at the annual meeting of the American Association of Endocrine Surgeons (AAES).

Management of thyroid nodules indeterminate for malignancy after fine needle aspiration, which occurs in up to 30% of patients, is a challenge, according to Dr. Wu. Cancer rates in these patients can be as high as 30%, and often benign and malignant indeterminate nodules are indistinguishable. Conventionally, surgical resection is recommended to avoid missing a cancer diagnosis. However, uniform thyroid lobectomy means that 70% or more of lesions excised will be benign.

GEC testing is a relatively new molecular test that helps guide therapy in these individuals. The high negative predictive value of this test allows the test to reliably predict when patients have benign disease, giving them the option of being observed rather than undergoing surgery, explained Dr. Wu. In this study, the goal was to determine whether GEC testing has the potential to be cost effective, defined as a ratio of added cost to QALYs gained of less than $100,000/QALY relative to conventional treatment.

The decision-tree model was constructed on 2 years of GEC testing performance data prospectively collected at UCLA. In this model, the assumption was made that patients would be observed if the GEC test was negative but would undergo thyroid resection if the gene expression classifier test was suspicious.

Applying the UCLA dataset to the model, the expected cost for conventional management in the reference scenario was $11,119 to produce 22.15 QALYs, according to Dr. Wu. Routine GEC testing produced an additional 0.01 QALY but cost $1,197 more. This translated into an incremental cost-effectiveness ratio of $119,700/QALY, which exceeded the common $100,000/QALY threshold for cost efficacy.

The main determinants of cost effectiveness were the cost of the gene expression classifier test, the rate of malignancy in patients with indeterminate thyroid nodules, and cost of thyroid lobectomy.

More favorable costs for gene expression testing could be generated by plausible alterations of key clinical factors. This included lowering the cost of the GEC test itself or raising the cost of thyroid lobectomy. For example, the GEC testing became cost effective with the parameters used if the test was less than $2,460 or the cost of thyroid lobectomy exceeded $12,160.

In addition, malignancy rates influenced the relative cost efficacy of gene expression classifier testing. Centers with lower rates of cancer get more value from routine GEC testing than do centers with high rates of cancer, because more patients avoid surgery with testing. At UCLA, the malignancy rate was 24%, and could pay as much as $2,460 per test to remain cost-effective. Institutions with a malignancy rate less than 24% would have a higher cost threshold.

Indeed, even though routine gene expression classifier testing was not found to be cost effective using the assumptions of this study and data from UCLA, on probabilistic sensitivity analysis, it was found to be cost effective in 53.2% of simulations. Dr. Wu suggested the same analyses should be performed at centers using their own data to accurately assess cost effectiveness. Given the wide variation in important variables, particularly the malignancy rate in indeterminate nodules, the results from one institution cannot reliably predict the cost effectiveness at a separate treatment facility.

“Our conclusion is that every center needs to audit themselves to find out whether it’s truly cost effective and not blindly trust that it’s 100% cost effective across the board.” Dr. Wu reported. He noted that gene expression classifier testing, which has been used for 2 years at UCLA, is likely to be continued to be used but with a focus on making the test more cost effective by finding ways to use it more selectively.

In candidates for thyroid surgery, ultrasound is an effective and convenient method of preoperative vocal cord evaluation, avoiding the costs of laryngoscopy, according to data derived from a retrospective study presented at the annual meeting of the American Association of Endocrine Surgeons in Nashville, Tenn.

In the study, which enrolled only those thyroid or parathyroid patients with risk factors for vocal cord paralysis, who would have been otherwise evaluated with flexible laryngoscopy, vocal cord ultrasonography (VCUS) proved to be an adequate examination in 76%, reported Dr. Denise Carneiro-Pla of the division of oncologic and endocrine surgery at the Medical University of South Carolina, Charleston.

Courtesy Denise Carneiro-Pla

The results have been practice-changing, she said. In thyroid or parathyroid surgical candidates at risk for vocal cord paralysis, flexible laryngoscopy had been the standard of care. When VCUS is adequate for visualization, it permits patients to avoid a separate office visit and an invasive procedure that many experience as uncomfortable. Based on data from this study, cost savings are substantial.

In patients scheduled for thyroid or parathyroid surgery, “ultrasound evaluation is already a routine part of the evaluation,” Dr. Carneiro-Pla explained. An evaluation of the vocal cords is easily performed at the same time, and visualization is typically adequate.

“You either have good visualization or you don’t,” she noted. “In the minority of cases when you do not, the patient can be referred for laryngoscopy.”

This assertion was supported by her study, which included a total of 194 consecutive patients from three institutions who were scheduled for thyroid or parathyroid surgery and had an indication for preoperative evaluation of vocal cord mobility. These indications included previous cervical procedures, a large goiter, significant hoarseness, and thyroid cancer suspected of possible extrathyroidal extension. All patients underwent VCUS, but 52 underwent flexible laryngoscopy regardless of the VCUS findings while 142 only underwent laryngoscopy if the VCUS was considered inadequate.

Overall, VCUS was judged to be adequate for evaluating vocal cord mobility in 164 (85%) of the total study population. In the group of patients for whom laryngoscopy was employed only if VCUS was not considered adequate, 24% did go on to the invasive procedure. The reasons were inadequate visualization in 11%, significant hoarseness despite normal VCUS in 8%, a finding of vocal cord weakness or paresis on VCUS that required further evaluation in 4%, and a surgeon decision or another reason in 1%.

In a comparison to those with adequate VCUS visualization, those without were, on average, older by 4 years and more likely to be male than female. Those with thyroid cartilage calcification were substantially less likely to have adequate visualization on VCUS than those without (57% vs. 92%; P < 0.005). Body mass index did not influence the adequacy of VCUS.

In patients at risk of vocal cord paralysis, Dr. Carneiro-Pla explained that some form of preoperative evaluation is considered essential to reduce the risk of a recurrent laryngeal nerve injury. Several previous studies have suggested that VCUS is accurate for predicting vocal cord paralysis, and this study reinforced this approach in routine patient care.

“An ultrasound evaluation would be performed in most patients anyway, so this avoids an extra step,” said Dr. Carneiro-Pla, whose study included a cost analysis that projected savings for the study group ranging from nearly $8,000 to more than $20,000.

She reported no relevant financial conflicts.

In candidates for thyroid surgery, ultrasound is an effective and convenient method of preoperative vocal cord evaluation, avoiding the costs of laryngoscopy, according to data derived from a retrospective study presented at the annual meeting of the American Association of Endocrine Surgeons in Nashville, Tenn.

In the study, which enrolled only those thyroid or parathyroid patients with risk factors for vocal cord paralysis, who would have been otherwise evaluated with flexible laryngoscopy, vocal cord ultrasonography (VCUS) proved to be an adequate examination in 76%, reported Dr. Denise Carneiro-Pla of the division of oncologic and endocrine surgery at the Medical University of South Carolina, Charleston.

Courtesy Denise Carneiro-Pla

The results have been practice-changing, she said. In thyroid or parathyroid surgical candidates at risk for vocal cord paralysis, flexible laryngoscopy had been the standard of care. When VCUS is adequate for visualization, it permits patients to avoid a separate office visit and an invasive procedure that many experience as uncomfortable. Based on data from this study, cost savings are substantial.

In patients scheduled for thyroid or parathyroid surgery, “ultrasound evaluation is already a routine part of the evaluation,” Dr. Carneiro-Pla explained. An evaluation of the vocal cords is easily performed at the same time, and visualization is typically adequate.

“You either have good visualization or you don’t,” she noted. “In the minority of cases when you do not, the patient can be referred for laryngoscopy.”

This assertion was supported by her study, which included a total of 194 consecutive patients from three institutions who were scheduled for thyroid or parathyroid surgery and had an indication for preoperative evaluation of vocal cord mobility. These indications included previous cervical procedures, a large goiter, significant hoarseness, and thyroid cancer suspected of possible extrathyroidal extension. All patients underwent VCUS, but 52 underwent flexible laryngoscopy regardless of the VCUS findings while 142 only underwent laryngoscopy if the VCUS was considered inadequate.

Overall, VCUS was judged to be adequate for evaluating vocal cord mobility in 164 (85%) of the total study population. In the group of patients for whom laryngoscopy was employed only if VCUS was not considered adequate, 24% did go on to the invasive procedure. The reasons were inadequate visualization in 11%, significant hoarseness despite normal VCUS in 8%, a finding of vocal cord weakness or paresis on VCUS that required further evaluation in 4%, and a surgeon decision or another reason in 1%.

In a comparison to those with adequate VCUS visualization, those without were, on average, older by 4 years and more likely to be male than female. Those with thyroid cartilage calcification were substantially less likely to have adequate visualization on VCUS than those without (57% vs. 92%; P < 0.005). Body mass index did not influence the adequacy of VCUS.

In patients at risk of vocal cord paralysis, Dr. Carneiro-Pla explained that some form of preoperative evaluation is considered essential to reduce the risk of a recurrent laryngeal nerve injury. Several previous studies have suggested that VCUS is accurate for predicting vocal cord paralysis, and this study reinforced this approach in routine patient care.

“An ultrasound evaluation would be performed in most patients anyway, so this avoids an extra step,” said Dr. Carneiro-Pla, whose study included a cost analysis that projected savings for the study group ranging from nearly $8,000 to more than $20,000.

She reported no relevant financial conflicts.

In candidates for thyroid surgery, ultrasound is an effective and convenient method of preoperative vocal cord evaluation, avoiding the costs of laryngoscopy, according to data derived from a retrospective study presented at the annual meeting of the American Association of Endocrine Surgeons in Nashville, Tenn.

In the study, which enrolled only those thyroid or parathyroid patients with risk factors for vocal cord paralysis, who would have been otherwise evaluated with flexible laryngoscopy, vocal cord ultrasonography (VCUS) proved to be an adequate examination in 76%, reported Dr. Denise Carneiro-Pla of the division of oncologic and endocrine surgery at the Medical University of South Carolina, Charleston.

Courtesy Denise Carneiro-Pla

The results have been practice-changing, she said. In thyroid or parathyroid surgical candidates at risk for vocal cord paralysis, flexible laryngoscopy had been the standard of care. When VCUS is adequate for visualization, it permits patients to avoid a separate office visit and an invasive procedure that many experience as uncomfortable. Based on data from this study, cost savings are substantial.

In patients scheduled for thyroid or parathyroid surgery, “ultrasound evaluation is already a routine part of the evaluation,” Dr. Carneiro-Pla explained. An evaluation of the vocal cords is easily performed at the same time, and visualization is typically adequate.

“You either have good visualization or you don’t,” she noted. “In the minority of cases when you do not, the patient can be referred for laryngoscopy.”

This assertion was supported by her study, which included a total of 194 consecutive patients from three institutions who were scheduled for thyroid or parathyroid surgery and had an indication for preoperative evaluation of vocal cord mobility. These indications included previous cervical procedures, a large goiter, significant hoarseness, and thyroid cancer suspected of possible extrathyroidal extension. All patients underwent VCUS, but 52 underwent flexible laryngoscopy regardless of the VCUS findings while 142 only underwent laryngoscopy if the VCUS was considered inadequate.

Overall, VCUS was judged to be adequate for evaluating vocal cord mobility in 164 (85%) of the total study population. In the group of patients for whom laryngoscopy was employed only if VCUS was not considered adequate, 24% did go on to the invasive procedure. The reasons were inadequate visualization in 11%, significant hoarseness despite normal VCUS in 8%, a finding of vocal cord weakness or paresis on VCUS that required further evaluation in 4%, and a surgeon decision or another reason in 1%.

In a comparison to those with adequate VCUS visualization, those without were, on average, older by 4 years and more likely to be male than female. Those with thyroid cartilage calcification were substantially less likely to have adequate visualization on VCUS than those without (57% vs. 92%; P < 0.005). Body mass index did not influence the adequacy of VCUS.

In patients at risk of vocal cord paralysis, Dr. Carneiro-Pla explained that some form of preoperative evaluation is considered essential to reduce the risk of a recurrent laryngeal nerve injury. Several previous studies have suggested that VCUS is accurate for predicting vocal cord paralysis, and this study reinforced this approach in routine patient care.

“An ultrasound evaluation would be performed in most patients anyway, so this avoids an extra step,” said Dr. Carneiro-Pla, whose study included a cost analysis that projected savings for the study group ranging from nearly $8,000 to more than $20,000.

She reported no relevant financial conflicts.

BOSTON – There may be no area of clinical medicine in which strict adherence to medical standards is more important than in the prescription of opioids.

Rather than malpractice, the consequence of deviations from accepted standards is often criminal prosecution, Dr. Carol A. Warfield said at the International Conference on Opioids.

Some physicians, believing they have acted in the best interests of the patient, have been sent to jail, said Dr. Warfield, professor of anesthesiology at Harvard Medical School, Boston. “Juries don’t seem to understand the difference between malpractice and criminal activity.”

©Comstock/thinkstockphotos.com

The distinctions are large, she said. In the case of opioids, criminal practice occurs when prescriptions are dispensed without a legitimate medical purpose. Inappropriate prescription of opioids, however, may be malpractice but it is not criminal, particularly if the underlying intent was to relieve patient suffering.

But that distinction is not necessarily recognized in the courtroom. Dr. Warfield recounted numerous criminal cases involving opioids in which the intent of the physician was to relieve pain. Prosecutors in those cases pointed to incomplete records or the lack of a physical examination to convince juries that a crime had been committed.

Often, a criminal prosecution begins with an opioid overdose. Charges may ensue with a review of the medical records that leads prosecutors to believe that standard practices were not followed. But bad outcomes are not essential to trigger an investigation.

Other cases start with an insurance company review, Dr. Warfield cautioned. “High utilization and increased costs push [insurers] to investigate doctors with peer review, and many criminal cases start with an insurance company that thought the clinician was prescribing too much of an expensive drug.”

What can physicians do to protect themselves from these accusations? Ensure that opioids are prescribed within the acceptable standards of practice, which includes first creating a clear physician-patient relationship, Dr. Warfield advised. Opioids should not be prescribed without a physical and history that provides a basis for the diagnosis. And provide clear documentation for each step of care, she emphasized.

Dr. Warfield acknowledged that she “is not a big advocate of using opioids for chronic pain” in her own practice. However, “I am a big advocate of a doctor’s right to do so.”

The risks of malpractice suits and criminal prosecution have already produced some defensive behaviors, inducing a growing number of physicians to abandon opioids altogether, she said. Others will give opioid injections, but will not prescribe opioids in any other form. Still others insist on lengthy consent forms that outline opioid risks.

Dr. Steven J. Bennett, director of pain services at Greenwich (Conn.) Hospital said that he is concerned about the current climate.

“I am very careful in my practice. I document everything,” Dr. Bennett said. However, “opioids are useful in my practice. They can help the right patient, so I am going to keep using them. I just plan to be very careful.”

BOSTON – There may be no area of clinical medicine in which strict adherence to medical standards is more important than in the prescription of opioids.

Rather than malpractice, the consequence of deviations from accepted standards is often criminal prosecution, Dr. Carol A. Warfield said at the International Conference on Opioids.

Some physicians, believing they have acted in the best interests of the patient, have been sent to jail, said Dr. Warfield, professor of anesthesiology at Harvard Medical School, Boston. “Juries don’t seem to understand the difference between malpractice and criminal activity.”

©Comstock/thinkstockphotos.com

The distinctions are large, she said. In the case of opioids, criminal practice occurs when prescriptions are dispensed without a legitimate medical purpose. Inappropriate prescription of opioids, however, may be malpractice but it is not criminal, particularly if the underlying intent was to relieve patient suffering.

But that distinction is not necessarily recognized in the courtroom. Dr. Warfield recounted numerous criminal cases involving opioids in which the intent of the physician was to relieve pain. Prosecutors in those cases pointed to incomplete records or the lack of a physical examination to convince juries that a crime had been committed.

Often, a criminal prosecution begins with an opioid overdose. Charges may ensue with a review of the medical records that leads prosecutors to believe that standard practices were not followed. But bad outcomes are not essential to trigger an investigation.

Other cases start with an insurance company review, Dr. Warfield cautioned. “High utilization and increased costs push [insurers] to investigate doctors with peer review, and many criminal cases start with an insurance company that thought the clinician was prescribing too much of an expensive drug.”

What can physicians do to protect themselves from these accusations? Ensure that opioids are prescribed within the acceptable standards of practice, which includes first creating a clear physician-patient relationship, Dr. Warfield advised. Opioids should not be prescribed without a physical and history that provides a basis for the diagnosis. And provide clear documentation for each step of care, she emphasized.

Dr. Warfield acknowledged that she “is not a big advocate of using opioids for chronic pain” in her own practice. However, “I am a big advocate of a doctor’s right to do so.”

The risks of malpractice suits and criminal prosecution have already produced some defensive behaviors, inducing a growing number of physicians to abandon opioids altogether, she said. Others will give opioid injections, but will not prescribe opioids in any other form. Still others insist on lengthy consent forms that outline opioid risks.

Dr. Steven J. Bennett, director of pain services at Greenwich (Conn.) Hospital said that he is concerned about the current climate.

“I am very careful in my practice. I document everything,” Dr. Bennett said. However, “opioids are useful in my practice. They can help the right patient, so I am going to keep using them. I just plan to be very careful.”

BOSTON – There may be no area of clinical medicine in which strict adherence to medical standards is more important than in the prescription of opioids.

Rather than malpractice, the consequence of deviations from accepted standards is often criminal prosecution, Dr. Carol A. Warfield said at the International Conference on Opioids.

Some physicians, believing they have acted in the best interests of the patient, have been sent to jail, said Dr. Warfield, professor of anesthesiology at Harvard Medical School, Boston. “Juries don’t seem to understand the difference between malpractice and criminal activity.”

©Comstock/thinkstockphotos.com

The distinctions are large, she said. In the case of opioids, criminal practice occurs when prescriptions are dispensed without a legitimate medical purpose. Inappropriate prescription of opioids, however, may be malpractice but it is not criminal, particularly if the underlying intent was to relieve patient suffering.

But that distinction is not necessarily recognized in the courtroom. Dr. Warfield recounted numerous criminal cases involving opioids in which the intent of the physician was to relieve pain. Prosecutors in those cases pointed to incomplete records or the lack of a physical examination to convince juries that a crime had been committed.

Often, a criminal prosecution begins with an opioid overdose. Charges may ensue with a review of the medical records that leads prosecutors to believe that standard practices were not followed. But bad outcomes are not essential to trigger an investigation.

Other cases start with an insurance company review, Dr. Warfield cautioned. “High utilization and increased costs push [insurers] to investigate doctors with peer review, and many criminal cases start with an insurance company that thought the clinician was prescribing too much of an expensive drug.”

What can physicians do to protect themselves from these accusations? Ensure that opioids are prescribed within the acceptable standards of practice, which includes first creating a clear physician-patient relationship, Dr. Warfield advised. Opioids should not be prescribed without a physical and history that provides a basis for the diagnosis. And provide clear documentation for each step of care, she emphasized.

Dr. Warfield acknowledged that she “is not a big advocate of using opioids for chronic pain” in her own practice. However, “I am a big advocate of a doctor’s right to do so.”

The risks of malpractice suits and criminal prosecution have already produced some defensive behaviors, inducing a growing number of physicians to abandon opioids altogether, she said. Others will give opioid injections, but will not prescribe opioids in any other form. Still others insist on lengthy consent forms that outline opioid risks.

Dr. Steven J. Bennett, director of pain services at Greenwich (Conn.) Hospital said that he is concerned about the current climate.

“I am very careful in my practice. I document everything,” Dr. Bennett said. However, “opioids are useful in my practice. They can help the right patient, so I am going to keep using them. I just plan to be very careful.”

Antibiotic therapy failed to be shown as noninferior to surgery in a study of adults with uncomplicated acute appendicitis, but it did resolve the problem and avert surgery with no adverse effects in 73% of patients, according to a report published online June 15 in JAMA.

Moreover, patients who did require surgery after initial antibiotic treatment did not develop significant complications and arguably were no worse off than were those who were operated on immediately. In fact, the overall complication rate was 2.8% among patients assigned to antibiotics and 7% among those assigned to antibiotics who eventually underwent appendectomy, compared with a 20.5% complication rate among patients assigned to surgery, said Dr. Paulina Salminen of the division of digestive surgery and urology, Turku (Finland) University Hospital, and her associates.

© decade3d/Thinkstockphotos

Their findings indicate that acute uncomplicated appendicitis need no longer be considered a surgical emergency, and that delaying the operation while trying a course of antibiotics “has few consequences,” they noted.

The few previous studies that have compared the two approaches had many limitations, including small study populations.

For their study, the Appendicitis Acuta (AAPAC) trial, Dr. Salminen and her associates included 530 patients aged 18-60 years who presented to six Finnish hospitals with suspected appendicitis during a 2-year period and were followed for 1 year. Appendicitis was confirmed via computed tomography (CT). Patients who had an appendicolith, perforation, abscess, or tumor were excluded from the study.

A total of 273 patients were randomly assigned to undergo immediate open appendectomy (with preoperative prophylactic antibiotics) and the remaining 257 were assigned to a 3-day course of IV ertapenem followed by 7 days of oral levofloxacin and metronidazole. If progressive infection, perforation, or peritonitis was suspected, appendectomy was performed.

Previous studies of uncomplicated appendicitis treated with antibiotics found a 70%-80% success rate, so the researchers prespecified criteria for noninferiority to surgery at 75% for the study group.

The primary endpoint for the antibiotic group – resolution of acute appendicitis with no recurrences for a full year – occurred in 73%. The remaining 27% of patients in this group underwent appendectomy during follow-up, at a median of 102 days after initial presentation. None of these patients developed abscesses or serious infections, “suggesting that the decision to delay appendectomy ... can be made with a low likelihood of major complications,” the investigators said (JAMA 2015 June 15 [doi:10.1001/jama.2015.6154]). Nevertheless, antibiotic treatment did not qualify as noninferior to immediate surgery according to the study’s preset definitions, they said.

This study was supported by a government research grant from the EVO Foundation to Turku University Hospital. Dr. Salminen reported receiving lecture fees from Merck and Roche; there were no other financial disclosures.

Antibiotic therapy failed to be shown as noninferior to surgery in a study of adults with uncomplicated acute appendicitis, but it did resolve the problem and avert surgery with no adverse effects in 73% of patients, according to a report published online June 15 in JAMA.

Moreover, patients who did require surgery after initial antibiotic treatment did not develop significant complications and arguably were no worse off than were those who were operated on immediately. In fact, the overall complication rate was 2.8% among patients assigned to antibiotics and 7% among those assigned to antibiotics who eventually underwent appendectomy, compared with a 20.5% complication rate among patients assigned to surgery, said Dr. Paulina Salminen of the division of digestive surgery and urology, Turku (Finland) University Hospital, and her associates.

© decade3d/Thinkstockphotos

Their findings indicate that acute uncomplicated appendicitis need no longer be considered a surgical emergency, and that delaying the operation while trying a course of antibiotics “has few consequences,” they noted.

The few previous studies that have compared the two approaches had many limitations, including small study populations.

For their study, the Appendicitis Acuta (AAPAC) trial, Dr. Salminen and her associates included 530 patients aged 18-60 years who presented to six Finnish hospitals with suspected appendicitis during a 2-year period and were followed for 1 year. Appendicitis was confirmed via computed tomography (CT). Patients who had an appendicolith, perforation, abscess, or tumor were excluded from the study.

A total of 273 patients were randomly assigned to undergo immediate open appendectomy (with preoperative prophylactic antibiotics) and the remaining 257 were assigned to a 3-day course of IV ertapenem followed by 7 days of oral levofloxacin and metronidazole. If progressive infection, perforation, or peritonitis was suspected, appendectomy was performed.

Previous studies of uncomplicated appendicitis treated with antibiotics found a 70%-80% success rate, so the researchers prespecified criteria for noninferiority to surgery at 75% for the study group.

The primary endpoint for the antibiotic group – resolution of acute appendicitis with no recurrences for a full year – occurred in 73%. The remaining 27% of patients in this group underwent appendectomy during follow-up, at a median of 102 days after initial presentation. None of these patients developed abscesses or serious infections, “suggesting that the decision to delay appendectomy ... can be made with a low likelihood of major complications,” the investigators said (JAMA 2015 June 15 [doi:10.1001/jama.2015.6154]). Nevertheless, antibiotic treatment did not qualify as noninferior to immediate surgery according to the study’s preset definitions, they said.

This study was supported by a government research grant from the EVO Foundation to Turku University Hospital. Dr. Salminen reported receiving lecture fees from Merck and Roche; there were no other financial disclosures.

Antibiotic therapy failed to be shown as noninferior to surgery in a study of adults with uncomplicated acute appendicitis, but it did resolve the problem and avert surgery with no adverse effects in 73% of patients, according to a report published online June 15 in JAMA.

Moreover, patients who did require surgery after initial antibiotic treatment did not develop significant complications and arguably were no worse off than were those who were operated on immediately. In fact, the overall complication rate was 2.8% among patients assigned to antibiotics and 7% among those assigned to antibiotics who eventually underwent appendectomy, compared with a 20.5% complication rate among patients assigned to surgery, said Dr. Paulina Salminen of the division of digestive surgery and urology, Turku (Finland) University Hospital, and her associates.

© decade3d/Thinkstockphotos

Their findings indicate that acute uncomplicated appendicitis need no longer be considered a surgical emergency, and that delaying the operation while trying a course of antibiotics “has few consequences,” they noted.

The few previous studies that have compared the two approaches had many limitations, including small study populations.

For their study, the Appendicitis Acuta (AAPAC) trial, Dr. Salminen and her associates included 530 patients aged 18-60 years who presented to six Finnish hospitals with suspected appendicitis during a 2-year period and were followed for 1 year. Appendicitis was confirmed via computed tomography (CT). Patients who had an appendicolith, perforation, abscess, or tumor were excluded from the study.

A total of 273 patients were randomly assigned to undergo immediate open appendectomy (with preoperative prophylactic antibiotics) and the remaining 257 were assigned to a 3-day course of IV ertapenem followed by 7 days of oral levofloxacin and metronidazole. If progressive infection, perforation, or peritonitis was suspected, appendectomy was performed.

Previous studies of uncomplicated appendicitis treated with antibiotics found a 70%-80% success rate, so the researchers prespecified criteria for noninferiority to surgery at 75% for the study group.

The primary endpoint for the antibiotic group – resolution of acute appendicitis with no recurrences for a full year – occurred in 73%. The remaining 27% of patients in this group underwent appendectomy during follow-up, at a median of 102 days after initial presentation. None of these patients developed abscesses or serious infections, “suggesting that the decision to delay appendectomy ... can be made with a low likelihood of major complications,” the investigators said (JAMA 2015 June 15 [doi:10.1001/jama.2015.6154]). Nevertheless, antibiotic treatment did not qualify as noninferior to immediate surgery according to the study’s preset definitions, they said.

This study was supported by a government research grant from the EVO Foundation to Turku University Hospital. Dr. Salminen reported receiving lecture fees from Merck and Roche; there were no other financial disclosures.

BOSTON – Genetic tests for pain treatment efficacy are being marketed in the United States and Australia, but one expert argues that they are not ready for use in clinical practice.

There is evidence that variability in patient response to opioids is due to pharmacogenomics that define drug metabolism and receptor activity, but it is just one factor that cannot yet be teased out from others, according to a summary by one expert at the International Conference on Opioids.

©ktsimage/Thinkstock.com

“My view is that commercialization of current genetic tests of pain treatment efficacy with opioids is somewhat premature. Evidence is limited, and I think regulation is necessary,” said Dr. Andrew Somogyi, professor in clinical and experimental pharmacology, University of Adelaide (Australia).

Progress has been made in identifying genetic factors that influence response to opioids, but there are two barriers to clinically useful tools, according to Dr. Somogyi. One is that clinical utility has yet to be proven for any test in a well-designed trial. The other is that even if pharmacogenomics features are relevant, the quality of commercial tests must be validated.

There are now at least two companies marketing genetic tests to guide selection of analgesics in the United States as well as one in Australia, but Dr. Somogyi said that neither the U.S. Food and Drug Administration nor the Australian Therapeutic Goods Administration provides any regulatory oversight. He noted that prices for the testing vary, but he believes that there is no evidence that analgesia can be improved by acting on test results.

As an example, he noted that the company in Australia employs genetic predictors of CYP2D6 function, an enzyme important to opioid metabolism, to estimate benefit from this class of analgesics. However, published studies have not yet generated compelling evidence that this is clinically relevant for either improving pain control or avoiding adverse events.

In the case of oxycodone, studies comparing poor metabolizers to ultra-rapid metabolizers do show important differences in experimental models of pain, but “clinical studies have really shown no effect,” Dr. Somogyi said.

He drew the same conclusion about CYP2D6 function in regard to the effects of codeine and the variants in the OPRM1 gene and their effect on the Mu receptor and response to morphine. In all cases, there are studies to suggest genetic differences are meaningful in experimental models, but no evidence from a clinical study to show that acting on this information changes outcome or otherwise improves care.

Although he acknowledged that it is tempting to believe pharmacogenetics can explain the well-known variability in response to analgesics, “other factors are just swamping these pharmacogenetics variables,” Dr. Somogyi maintained. Not least of these other factors are the psychosocial factors that influence response to pain stimuli.

This does not preclude an eventual role for pharmacogenetics in the selection of analgesics. Dr. Somogyi, who has been working in this area for several decades, outlined a broad array of promising areas of research. It is the current clinical application of pharmacogenetics with which Dr. Somogyi took issue. He criticized many of the marketing claims made on behalf of available tests, which he considers unsubstantiated.

Deferring to the expertise of Dr. Somogyi, Dr. Paul A. Sloan, professor and vice chair for research, University of Kentucky, Lexington, said he found the perspective compelling. In an interview, Dr. Sloan, cochair of the 2015 ICOO meeting, reported that he knows of no one using pharmacogenetics testing to guide analgesic choice, and he reiterated Dr. Somogyi’s concerns about the need to validate the quality of tests as a part of an effort to confirm their viability as clinical tools.

Dr. Somogyi reported having no financial disclosures.

BOSTON – Genetic tests for pain treatment efficacy are being marketed in the United States and Australia, but one expert argues that they are not ready for use in clinical practice.

There is evidence that variability in patient response to opioids is due to pharmacogenomics that define drug metabolism and receptor activity, but it is just one factor that cannot yet be teased out from others, according to a summary by one expert at the International Conference on Opioids.

©ktsimage/Thinkstock.com

“My view is that commercialization of current genetic tests of pain treatment efficacy with opioids is somewhat premature. Evidence is limited, and I think regulation is necessary,” said Dr. Andrew Somogyi, professor in clinical and experimental pharmacology, University of Adelaide (Australia).

Progress has been made in identifying genetic factors that influence response to opioids, but there are two barriers to clinically useful tools, according to Dr. Somogyi. One is that clinical utility has yet to be proven for any test in a well-designed trial. The other is that even if pharmacogenomics features are relevant, the quality of commercial tests must be validated.

There are now at least two companies marketing genetic tests to guide selection of analgesics in the United States as well as one in Australia, but Dr. Somogyi said that neither the U.S. Food and Drug Administration nor the Australian Therapeutic Goods Administration provides any regulatory oversight. He noted that prices for the testing vary, but he believes that there is no evidence that analgesia can be improved by acting on test results.

As an example, he noted that the company in Australia employs genetic predictors of CYP2D6 function, an enzyme important to opioid metabolism, to estimate benefit from this class of analgesics. However, published studies have not yet generated compelling evidence that this is clinically relevant for either improving pain control or avoiding adverse events.

In the case of oxycodone, studies comparing poor metabolizers to ultra-rapid metabolizers do show important differences in experimental models of pain, but “clinical studies have really shown no effect,” Dr. Somogyi said.

He drew the same conclusion about CYP2D6 function in regard to the effects of codeine and the variants in the OPRM1 gene and their effect on the Mu receptor and response to morphine. In all cases, there are studies to suggest genetic differences are meaningful in experimental models, but no evidence from a clinical study to show that acting on this information changes outcome or otherwise improves care.

Although he acknowledged that it is tempting to believe pharmacogenetics can explain the well-known variability in response to analgesics, “other factors are just swamping these pharmacogenetics variables,” Dr. Somogyi maintained. Not least of these other factors are the psychosocial factors that influence response to pain stimuli.

This does not preclude an eventual role for pharmacogenetics in the selection of analgesics. Dr. Somogyi, who has been working in this area for several decades, outlined a broad array of promising areas of research. It is the current clinical application of pharmacogenetics with which Dr. Somogyi took issue. He criticized many of the marketing claims made on behalf of available tests, which he considers unsubstantiated.

Deferring to the expertise of Dr. Somogyi, Dr. Paul A. Sloan, professor and vice chair for research, University of Kentucky, Lexington, said he found the perspective compelling. In an interview, Dr. Sloan, cochair of the 2015 ICOO meeting, reported that he knows of no one using pharmacogenetics testing to guide analgesic choice, and he reiterated Dr. Somogyi’s concerns about the need to validate the quality of tests as a part of an effort to confirm their viability as clinical tools.

Dr. Somogyi reported having no financial disclosures.

BOSTON – Genetic tests for pain treatment efficacy are being marketed in the United States and Australia, but one expert argues that they are not ready for use in clinical practice.

There is evidence that variability in patient response to opioids is due to pharmacogenomics that define drug metabolism and receptor activity, but it is just one factor that cannot yet be teased out from others, according to a summary by one expert at the International Conference on Opioids.

©ktsimage/Thinkstock.com

“My view is that commercialization of current genetic tests of pain treatment efficacy with opioids is somewhat premature. Evidence is limited, and I think regulation is necessary,” said Dr. Andrew Somogyi, professor in clinical and experimental pharmacology, University of Adelaide (Australia).

Progress has been made in identifying genetic factors that influence response to opioids, but there are two barriers to clinically useful tools, according to Dr. Somogyi. One is that clinical utility has yet to be proven for any test in a well-designed trial. The other is that even if pharmacogenomics features are relevant, the quality of commercial tests must be validated.

There are now at least two companies marketing genetic tests to guide selection of analgesics in the United States as well as one in Australia, but Dr. Somogyi said that neither the U.S. Food and Drug Administration nor the Australian Therapeutic Goods Administration provides any regulatory oversight. He noted that prices for the testing vary, but he believes that there is no evidence that analgesia can be improved by acting on test results.

As an example, he noted that the company in Australia employs genetic predictors of CYP2D6 function, an enzyme important to opioid metabolism, to estimate benefit from this class of analgesics. However, published studies have not yet generated compelling evidence that this is clinically relevant for either improving pain control or avoiding adverse events.

In the case of oxycodone, studies comparing poor metabolizers to ultra-rapid metabolizers do show important differences in experimental models of pain, but “clinical studies have really shown no effect,” Dr. Somogyi said.

He drew the same conclusion about CYP2D6 function in regard to the effects of codeine and the variants in the OPRM1 gene and their effect on the Mu receptor and response to morphine. In all cases, there are studies to suggest genetic differences are meaningful in experimental models, but no evidence from a clinical study to show that acting on this information changes outcome or otherwise improves care.

Although he acknowledged that it is tempting to believe pharmacogenetics can explain the well-known variability in response to analgesics, “other factors are just swamping these pharmacogenetics variables,” Dr. Somogyi maintained. Not least of these other factors are the psychosocial factors that influence response to pain stimuli.

This does not preclude an eventual role for pharmacogenetics in the selection of analgesics. Dr. Somogyi, who has been working in this area for several decades, outlined a broad array of promising areas of research. It is the current clinical application of pharmacogenetics with which Dr. Somogyi took issue. He criticized many of the marketing claims made on behalf of available tests, which he considers unsubstantiated.

Deferring to the expertise of Dr. Somogyi, Dr. Paul A. Sloan, professor and vice chair for research, University of Kentucky, Lexington, said he found the perspective compelling. In an interview, Dr. Sloan, cochair of the 2015 ICOO meeting, reported that he knows of no one using pharmacogenetics testing to guide analgesic choice, and he reiterated Dr. Somogyi’s concerns about the need to validate the quality of tests as a part of an effort to confirm their viability as clinical tools.

Dr. Somogyi reported having no financial disclosures.

WASHINGTON – Performed when recommended, cholecystecomy significantly decreases the risk of near-term rehospitalization for acute biliary pancreatitis, results of a retrospective study indicate.

Among more than 23,000 patients with mild to moderate acute biliary pancreatitis, less than 2% of those who underwent cholecystectomy within 30 days, as recommended under American Gastroenterological Association guidelines, were rehospitalized for pancreatitis within 6 months. In contrast, nearly 17% of patients who had cholecystectomy after 1 month or never had it were back in the hospital within half a year, said Dr. Ayesha Kamal, a postdoctoral research fellow at the Johns Hopkins Hospital in Baltimore.

“Cholecystectomy prevents future hospitalization for biliary pancreatitis,” she said at the annual Digestive Disease Week.

The study, based on claims data, also showed that adherence to AGA guidelines is fairly high, on the order of 75%, she said.

Acute pancreatitis is one of the most common gastrointestinal diseases in the United States, accounting for about 300,000 hospitalizations in 2009, at a total cost of about $2.6 billion. Gallstone disease is the most common cause of acute pancreatitis, responsible for an estimated 40% of all cases, she said.

Guidelines from the AGA and other organizations recommend cholecystectomy either during the same hospitalization for acute biliary pancreatitis, or within 4 weeks. To see whether clinicians were adhering to the AGA guidelines and whether the guideline-recommended timing of cholecystectomy made a difference, Dr. Kamal and colleagues analyzed data from the MarketScan Commercial Claims & Encounters database, which includes individual-level clinical utilization data for both inpatient and outpatient visits paid for by employer-sponsored health plans.

They looked at data both on patients who were treated in accordance with guidelines (first hospitalization for mild to moderate acute biliary pancreatitis, with cholecystectomy performed either on the day of hospitalization or within 30 days), and outside of the guidelines (no cholecystectomy, or cholecystectomy performed later than 30 days after the index hospitalization).

They assessed recurrences within 30 days of follow-up by International Classification of Diseases, 9th Revision (ICD-9) codes for acute pancreatitis and gallstone disease.

Combing through 8.8 million adult inpatient encounters for acute biliary pancreatitis, they excluded those patients with a diagnosis of severe or chronic pancreatitis, alcohol abuse, less than 30 days of follow-up, deaths during hospitalization, discharge to hospice, and those with a length of stay longer than 30 days.

This left them with a final cohort of 23,515 patients with mild to moderate acute biliary pancreatitis.

They found that 61% of patients had cholecystectomy during their initial hospitalizations, and an additional 14% had the surgery during a subsequent hospitalization within 30 days. Of the remaining patients, 7% had cholecystectomies after 30 days, and 18% never had one.

Among patients treated under the guidelines, 1.3% who had their gallbladders removed during the initial hospitalization had a pancreatitis recurrence within 6 months, and 0.2% had a recurrence more than 6 months later.

In contrast, 36.7% of patients who had a cholecystectomy more than a month after their first hospitalization for pancreatitis had a recurrence within 6 months, and 4.5% had a recurrence after 6 months.

Among patients who never underwent cholecystectomy, the respective recurrence rates were 5.4% and 1.1%.

“One in six patients who did not receive a cholecystectomy within 30 days will be hospitalized again within 6 months,” Dr. Kamal said.

She acknowledged that the study was limited by the authors’ inability to confirm acute biliary pancreatitis with chart review, and by the limitations of the database, which is confined to adults younger than 65 with employer-sponsored medical plans.

In the question and answer portion of the presentation, Dr. Nirav Thosani, a gastroenterologist at Memorial Hermann Hospital in Houston, noted that ICD-9 codes do not distinguish between different types of pancreatitis.

“It might be possible that those patients who never had cholecystectomy never had acute biliary pancreatitis, or some other reason for acute pancreatitis, and that’s the reason for the rehospitalization,” he said.

Dr. Kamal replied that they tried to control for other causes of pancreatitis by including ICD-9 codes for gallstone disease and by excluding patients with diagnoses of alcohol abuse.

The study funding source was not disclosed. Dr. Kamal and Dr. Thosani reported having no relevant disclosures.

WASHINGTON – Performed when recommended, cholecystecomy significantly decreases the risk of near-term rehospitalization for acute biliary pancreatitis, results of a retrospective study indicate.

Among more than 23,000 patients with mild to moderate acute biliary pancreatitis, less than 2% of those who underwent cholecystectomy within 30 days, as recommended under American Gastroenterological Association guidelines, were rehospitalized for pancreatitis within 6 months. In contrast, nearly 17% of patients who had cholecystectomy after 1 month or never had it were back in the hospital within half a year, said Dr. Ayesha Kamal, a postdoctoral research fellow at the Johns Hopkins Hospital in Baltimore.

“Cholecystectomy prevents future hospitalization for biliary pancreatitis,” she said at the annual Digestive Disease Week.

The study, based on claims data, also showed that adherence to AGA guidelines is fairly high, on the order of 75%, she said.

Acute pancreatitis is one of the most common gastrointestinal diseases in the United States, accounting for about 300,000 hospitalizations in 2009, at a total cost of about $2.6 billion. Gallstone disease is the most common cause of acute pancreatitis, responsible for an estimated 40% of all cases, she said.

Guidelines from the AGA and other organizations recommend cholecystectomy either during the same hospitalization for acute biliary pancreatitis, or within 4 weeks. To see whether clinicians were adhering to the AGA guidelines and whether the guideline-recommended timing of cholecystectomy made a difference, Dr. Kamal and colleagues analyzed data from the MarketScan Commercial Claims & Encounters database, which includes individual-level clinical utilization data for both inpatient and outpatient visits paid for by employer-sponsored health plans.

They looked at data both on patients who were treated in accordance with guidelines (first hospitalization for mild to moderate acute biliary pancreatitis, with cholecystectomy performed either on the day of hospitalization or within 30 days), and outside of the guidelines (no cholecystectomy, or cholecystectomy performed later than 30 days after the index hospitalization).

They assessed recurrences within 30 days of follow-up by International Classification of Diseases, 9th Revision (ICD-9) codes for acute pancreatitis and gallstone disease.

Combing through 8.8 million adult inpatient encounters for acute biliary pancreatitis, they excluded those patients with a diagnosis of severe or chronic pancreatitis, alcohol abuse, less than 30 days of follow-up, deaths during hospitalization, discharge to hospice, and those with a length of stay longer than 30 days.

This left them with a final cohort of 23,515 patients with mild to moderate acute biliary pancreatitis.

They found that 61% of patients had cholecystectomy during their initial hospitalizations, and an additional 14% had the surgery during a subsequent hospitalization within 30 days. Of the remaining patients, 7% had cholecystectomies after 30 days, and 18% never had one.

Among patients treated under the guidelines, 1.3% who had their gallbladders removed during the initial hospitalization had a pancreatitis recurrence within 6 months, and 0.2% had a recurrence more than 6 months later.

In contrast, 36.7% of patients who had a cholecystectomy more than a month after their first hospitalization for pancreatitis had a recurrence within 6 months, and 4.5% had a recurrence after 6 months.

Among patients who never underwent cholecystectomy, the respective recurrence rates were 5.4% and 1.1%.

“One in six patients who did not receive a cholecystectomy within 30 days will be hospitalized again within 6 months,” Dr. Kamal said.

She acknowledged that the study was limited by the authors’ inability to confirm acute biliary pancreatitis with chart review, and by the limitations of the database, which is confined to adults younger than 65 with employer-sponsored medical plans.

In the question and answer portion of the presentation, Dr. Nirav Thosani, a gastroenterologist at Memorial Hermann Hospital in Houston, noted that ICD-9 codes do not distinguish between different types of pancreatitis.

“It might be possible that those patients who never had cholecystectomy never had acute biliary pancreatitis, or some other reason for acute pancreatitis, and that’s the reason for the rehospitalization,” he said.

Dr. Kamal replied that they tried to control for other causes of pancreatitis by including ICD-9 codes for gallstone disease and by excluding patients with diagnoses of alcohol abuse.

The study funding source was not disclosed. Dr. Kamal and Dr. Thosani reported having no relevant disclosures.

WASHINGTON – Performed when recommended, cholecystecomy significantly decreases the risk of near-term rehospitalization for acute biliary pancreatitis, results of a retrospective study indicate.

Among more than 23,000 patients with mild to moderate acute biliary pancreatitis, less than 2% of those who underwent cholecystectomy within 30 days, as recommended under American Gastroenterological Association guidelines, were rehospitalized for pancreatitis within 6 months. In contrast, nearly 17% of patients who had cholecystectomy after 1 month or never had it were back in the hospital within half a year, said Dr. Ayesha Kamal, a postdoctoral research fellow at the Johns Hopkins Hospital in Baltimore.

“Cholecystectomy prevents future hospitalization for biliary pancreatitis,” she said at the annual Digestive Disease Week.

The study, based on claims data, also showed that adherence to AGA guidelines is fairly high, on the order of 75%, she said.

Acute pancreatitis is one of the most common gastrointestinal diseases in the United States, accounting for about 300,000 hospitalizations in 2009, at a total cost of about $2.6 billion. Gallstone disease is the most common cause of acute pancreatitis, responsible for an estimated 40% of all cases, she said.

Guidelines from the AGA and other organizations recommend cholecystectomy either during the same hospitalization for acute biliary pancreatitis, or within 4 weeks. To see whether clinicians were adhering to the AGA guidelines and whether the guideline-recommended timing of cholecystectomy made a difference, Dr. Kamal and colleagues analyzed data from the MarketScan Commercial Claims & Encounters database, which includes individual-level clinical utilization data for both inpatient and outpatient visits paid for by employer-sponsored health plans.

They looked at data both on patients who were treated in accordance with guidelines (first hospitalization for mild to moderate acute biliary pancreatitis, with cholecystectomy performed either on the day of hospitalization or within 30 days), and outside of the guidelines (no cholecystectomy, or cholecystectomy performed later than 30 days after the index hospitalization).

They assessed recurrences within 30 days of follow-up by International Classification of Diseases, 9th Revision (ICD-9) codes for acute pancreatitis and gallstone disease.

Combing through 8.8 million adult inpatient encounters for acute biliary pancreatitis, they excluded those patients with a diagnosis of severe or chronic pancreatitis, alcohol abuse, less than 30 days of follow-up, deaths during hospitalization, discharge to hospice, and those with a length of stay longer than 30 days.

This left them with a final cohort of 23,515 patients with mild to moderate acute biliary pancreatitis.

They found that 61% of patients had cholecystectomy during their initial hospitalizations, and an additional 14% had the surgery during a subsequent hospitalization within 30 days. Of the remaining patients, 7% had cholecystectomies after 30 days, and 18% never had one.

Among patients treated under the guidelines, 1.3% who had their gallbladders removed during the initial hospitalization had a pancreatitis recurrence within 6 months, and 0.2% had a recurrence more than 6 months later.

In contrast, 36.7% of patients who had a cholecystectomy more than a month after their first hospitalization for pancreatitis had a recurrence within 6 months, and 4.5% had a recurrence after 6 months.

Among patients who never underwent cholecystectomy, the respective recurrence rates were 5.4% and 1.1%.

“One in six patients who did not receive a cholecystectomy within 30 days will be hospitalized again within 6 months,” Dr. Kamal said.

She acknowledged that the study was limited by the authors’ inability to confirm acute biliary pancreatitis with chart review, and by the limitations of the database, which is confined to adults younger than 65 with employer-sponsored medical plans.

In the question and answer portion of the presentation, Dr. Nirav Thosani, a gastroenterologist at Memorial Hermann Hospital in Houston, noted that ICD-9 codes do not distinguish between different types of pancreatitis.

“It might be possible that those patients who never had cholecystectomy never had acute biliary pancreatitis, or some other reason for acute pancreatitis, and that’s the reason for the rehospitalization,” he said.

Dr. Kamal replied that they tried to control for other causes of pancreatitis by including ICD-9 codes for gallstone disease and by excluding patients with diagnoses of alcohol abuse.

The study funding source was not disclosed. Dr. Kamal and Dr. Thosani reported having no relevant disclosures.

BOSTON – A campaign promise to create viable strategies aimed at reducing the overuse of prescription opioids will be fulfilled, the governor of Massachusetts said during a keynote address at the International Conference on Opioids.

Without providing many specifics, Gov. Charles D. Baker (R) reported that the task force he created will soon release recommendations around three major components: 1. prevention and education; 2. addiction and intervention; and 3. the treatment of pain. He emphasized the importance of a comprehensive strategy.

Ted Bosworth/Frontline Medical News

“I am smart enough to know or humble enough to know that any one initiative in regard to this type of thing is unlikely to get us to where we need to go,” Gov. Baker said. Decriminalizing addiction will be part of the strategy aimed at reducing roadblocks to treatment, he said.

The opioid epidemic was not an initial part of Gov. Baker’s 2014 platform in his campaign for governor. Rather, he added a promise to address this problem in his inaugural address after voters expressed their concern repeatedly. He reported being “astonished” by how often he heard stories of addiction to prescription opioids.

“It didn’t matter where I was. It didn’t matter what part of the commonwealth I was in. It did not matter what kind of neighborhood I was in. It didn’t matter what the socioeconomic demographic makeup was of the group I was talking to,” Gov. Baker said. “It was literally everywhere.”

He said hard numbers tell the same story. In addition to the often repeated national statistics regarding the rapid increase in opioid prescriptions and its close correlation with opioid-related deaths, he said no area of Massachusetts has been left untouched. According to Gov. Baker, the largest hospital in the town of Plymouth, Mass., which has a population just under 60,000, is now averaging one opioid overdose per day.

“I am one of those people who thinks that you cannot solve this problem if you do not engage the health care community,” Gov. Baker said. One reason to focus on health care providers, the governor said, is that data from the Substance Abuse and Mental Health Services Administration show that a large percentage of patients addicted to heroin started on prescription pain medication.

The thrust of the coming initiatives is therefore likely to advocate pain medicine practice that reduces inappropriate prescriptions, Gov. Baker said. He noted that an initiative started 2 years ago by Blue Cross Blue Shield of Massachusetts resulted in a 25% reduction in opioid prescribing without restricting pain medications for those who need them.

In general, the address, which was heavily covered by the local news media, was well-received by those who attended the International Conference on Opioids. There was one area of disagreement. Many did not believe that most heroin addictions start with a prescription pain medication. Of those who challenged that assertion, Dr. Carol A. Warfield, the Lowenstein Distinguished Professor of Anesthesia at Harvard Medical School, Boston, clarified that those opioids might have been prescription drugs but were not prescribed to the user. Rather, the drugs were diverted, and this is a much more important focus of efforts to halt the epidemic than new restrictions on their use for pain control.

Similarly, Pamela J. Madej, a registered nurse affiliated with the Albany Center for Pain Management, New York, cautioned against overemphasizing the value of regulating opioids. She said plenty of regulations exist in New York but the problem persists. Many people are self-medicating for mental health disorders, she said, including the chronic brain disorder of addiction, for which coverage continues to be limited.

“Patients switch from hydrocodone to heroin, because heroin is cheaper,” Ms. Madej said. “We need expanded coverage for mental health to address the underlying problem.”

BOSTON – A campaign promise to create viable strategies aimed at reducing the overuse of prescription opioids will be fulfilled, the governor of Massachusetts said during a keynote address at the International Conference on Opioids.

Without providing many specifics, Gov. Charles D. Baker (R) reported that the task force he created will soon release recommendations around three major components: 1. prevention and education; 2. addiction and intervention; and 3. the treatment of pain. He emphasized the importance of a comprehensive strategy.

Ted Bosworth/Frontline Medical News

“I am smart enough to know or humble enough to know that any one initiative in regard to this type of thing is unlikely to get us to where we need to go,” Gov. Baker said. Decriminalizing addiction will be part of the strategy aimed at reducing roadblocks to treatment, he said.

The opioid epidemic was not an initial part of Gov. Baker’s 2014 platform in his campaign for governor. Rather, he added a promise to address this problem in his inaugural address after voters expressed their concern repeatedly. He reported being “astonished” by how often he heard stories of addiction to prescription opioids.

“It didn’t matter where I was. It didn’t matter what part of the commonwealth I was in. It did not matter what kind of neighborhood I was in. It didn’t matter what the socioeconomic demographic makeup was of the group I was talking to,” Gov. Baker said. “It was literally everywhere.”

He said hard numbers tell the same story. In addition to the often repeated national statistics regarding the rapid increase in opioid prescriptions and its close correlation with opioid-related deaths, he said no area of Massachusetts has been left untouched. According to Gov. Baker, the largest hospital in the town of Plymouth, Mass., which has a population just under 60,000, is now averaging one opioid overdose per day.

“I am one of those people who thinks that you cannot solve this problem if you do not engage the health care community,” Gov. Baker said. One reason to focus on health care providers, the governor said, is that data from the Substance Abuse and Mental Health Services Administration show that a large percentage of patients addicted to heroin started on prescription pain medication.

The thrust of the coming initiatives is therefore likely to advocate pain medicine practice that reduces inappropriate prescriptions, Gov. Baker said. He noted that an initiative started 2 years ago by Blue Cross Blue Shield of Massachusetts resulted in a 25% reduction in opioid prescribing without restricting pain medications for those who need them.

In general, the address, which was heavily covered by the local news media, was well-received by those who attended the International Conference on Opioids. There was one area of disagreement. Many did not believe that most heroin addictions start with a prescription pain medication. Of those who challenged that assertion, Dr. Carol A. Warfield, the Lowenstein Distinguished Professor of Anesthesia at Harvard Medical School, Boston, clarified that those opioids might have been prescription drugs but were not prescribed to the user. Rather, the drugs were diverted, and this is a much more important focus of efforts to halt the epidemic than new restrictions on their use for pain control.

Similarly, Pamela J. Madej, a registered nurse affiliated with the Albany Center for Pain Management, New York, cautioned against overemphasizing the value of regulating opioids. She said plenty of regulations exist in New York but the problem persists. Many people are self-medicating for mental health disorders, she said, including the chronic brain disorder of addiction, for which coverage continues to be limited.

“Patients switch from hydrocodone to heroin, because heroin is cheaper,” Ms. Madej said. “We need expanded coverage for mental health to address the underlying problem.”

BOSTON – A campaign promise to create viable strategies aimed at reducing the overuse of prescription opioids will be fulfilled, the governor of Massachusetts said during a keynote address at the International Conference on Opioids.

Without providing many specifics, Gov. Charles D. Baker (R) reported that the task force he created will soon release recommendations around three major components: 1. prevention and education; 2. addiction and intervention; and 3. the treatment of pain. He emphasized the importance of a comprehensive strategy.

Ted Bosworth/Frontline Medical News

“I am smart enough to know or humble enough to know that any one initiative in regard to this type of thing is unlikely to get us to where we need to go,” Gov. Baker said. Decriminalizing addiction will be part of the strategy aimed at reducing roadblocks to treatment, he said.

The opioid epidemic was not an initial part of Gov. Baker’s 2014 platform in his campaign for governor. Rather, he added a promise to address this problem in his inaugural address after voters expressed their concern repeatedly. He reported being “astonished” by how often he heard stories of addiction to prescription opioids.

“It didn’t matter where I was. It didn’t matter what part of the commonwealth I was in. It did not matter what kind of neighborhood I was in. It didn’t matter what the socioeconomic demographic makeup was of the group I was talking to,” Gov. Baker said. “It was literally everywhere.”

He said hard numbers tell the same story. In addition to the often repeated national statistics regarding the rapid increase in opioid prescriptions and its close correlation with opioid-related deaths, he said no area of Massachusetts has been left untouched. According to Gov. Baker, the largest hospital in the town of Plymouth, Mass., which has a population just under 60,000, is now averaging one opioid overdose per day.

“I am one of those people who thinks that you cannot solve this problem if you do not engage the health care community,” Gov. Baker said. One reason to focus on health care providers, the governor said, is that data from the Substance Abuse and Mental Health Services Administration show that a large percentage of patients addicted to heroin started on prescription pain medication.

The thrust of the coming initiatives is therefore likely to advocate pain medicine practice that reduces inappropriate prescriptions, Gov. Baker said. He noted that an initiative started 2 years ago by Blue Cross Blue Shield of Massachusetts resulted in a 25% reduction in opioid prescribing without restricting pain medications for those who need them.

In general, the address, which was heavily covered by the local news media, was well-received by those who attended the International Conference on Opioids. There was one area of disagreement. Many did not believe that most heroin addictions start with a prescription pain medication. Of those who challenged that assertion, Dr. Carol A. Warfield, the Lowenstein Distinguished Professor of Anesthesia at Harvard Medical School, Boston, clarified that those opioids might have been prescription drugs but were not prescribed to the user. Rather, the drugs were diverted, and this is a much more important focus of efforts to halt the epidemic than new restrictions on their use for pain control.

Similarly, Pamela J. Madej, a registered nurse affiliated with the Albany Center for Pain Management, New York, cautioned against overemphasizing the value of regulating opioids. She said plenty of regulations exist in New York but the problem persists. Many people are self-medicating for mental health disorders, she said, including the chronic brain disorder of addiction, for which coverage continues to be limited.

“Patients switch from hydrocodone to heroin, because heroin is cheaper,” Ms. Madej said. “We need expanded coverage for mental health to address the underlying problem.”

Poor communication remains at the heart of most surgical “never events” (i.e., preventable events), say the authors of a systematic review that estimates around 500 wrong-site surgeries and 5,000 retained surgical items incidents still happen each year in the United States.

The review of 138 empirical studies of wrong-site surgery, retained surgical items, and surgical fires, published between 2004 and 2014, found wrong-site surgery occurred roughly once per 100,000 surgical procedures, and retained surgical items incidents at a rate of 1.32 events per 10,000 procedures, with unknown data on the per-procedure incidence of surgical fire, according to data published online June 10 in JAMA Surgery.

©VILevi/thinkstockphotos.com

“A frequently reported cause of wrong-site surgery across 28 identified analyses was communication problems, including miscommunications among staff, missing information that should have been available to the operating room staff, surgical team members not speaking up when they noticed that a procedure targeted the wrong side, and a surgeon ignoring surgical team members who questioned laterality,” wrote Susanne Hempel, PhD, of the Southern California Evidence-Based Practice Center, Santa Monica, and her coauthors.

They found that very few evaluations of interventions designed specifically to reduce the incidence of never events were conclusive, although they pointed out that given the rarity of these events, it was methodologically challenging to assess the effectiveness of these interventions (JAMA Surg. 2015 June 10 [doi:10.1001/jamasurg.2015.0301]).

The Department of Veterans Affairs supported the study. There were no conflicts of interest declared.

Poor communication remains at the heart of most surgical “never events” (i.e., preventable events), say the authors of a systematic review that estimates around 500 wrong-site surgeries and 5,000 retained surgical items incidents still happen each year in the United States.

The review of 138 empirical studies of wrong-site surgery, retained surgical items, and surgical fires, published between 2004 and 2014, found wrong-site surgery occurred roughly once per 100,000 surgical procedures, and retained surgical items incidents at a rate of 1.32 events per 10,000 procedures, with unknown data on the per-procedure incidence of surgical fire, according to data published online June 10 in JAMA Surgery.

©VILevi/thinkstockphotos.com

“A frequently reported cause of wrong-site surgery across 28 identified analyses was communication problems, including miscommunications among staff, missing information that should have been available to the operating room staff, surgical team members not speaking up when they noticed that a procedure targeted the wrong side, and a surgeon ignoring surgical team members who questioned laterality,” wrote Susanne Hempel, PhD, of the Southern California Evidence-Based Practice Center, Santa Monica, and her coauthors.

They found that very few evaluations of interventions designed specifically to reduce the incidence of never events were conclusive, although they pointed out that given the rarity of these events, it was methodologically challenging to assess the effectiveness of these interventions (JAMA Surg. 2015 June 10 [doi:10.1001/jamasurg.2015.0301]).

The Department of Veterans Affairs supported the study. There were no conflicts of interest declared.

Poor communication remains at the heart of most surgical “never events” (i.e., preventable events), say the authors of a systematic review that estimates around 500 wrong-site surgeries and 5,000 retained surgical items incidents still happen each year in the United States.

The review of 138 empirical studies of wrong-site surgery, retained surgical items, and surgical fires, published between 2004 and 2014, found wrong-site surgery occurred roughly once per 100,000 surgical procedures, and retained surgical items incidents at a rate of 1.32 events per 10,000 procedures, with unknown data on the per-procedure incidence of surgical fire, according to data published online June 10 in JAMA Surgery.

©VILevi/thinkstockphotos.com

“A frequently reported cause of wrong-site surgery across 28 identified analyses was communication problems, including miscommunications among staff, missing information that should have been available to the operating room staff, surgical team members not speaking up when they noticed that a procedure targeted the wrong side, and a surgeon ignoring surgical team members who questioned laterality,” wrote Susanne Hempel, PhD, of the Southern California Evidence-Based Practice Center, Santa Monica, and her coauthors.

They found that very few evaluations of interventions designed specifically to reduce the incidence of never events were conclusive, although they pointed out that given the rarity of these events, it was methodologically challenging to assess the effectiveness of these interventions (JAMA Surg. 2015 June 10 [doi:10.1001/jamasurg.2015.0301]).

The Department of Veterans Affairs supported the study. There were no conflicts of interest declared.

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

[email protected]

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

[email protected]

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

[email protected]

NASHVILLE, TENN. – Postprandial hyperinsulinemic hypoglycemia after gastric bypass surgery can be managed or even corrected by medical management with calcium channel blockers or acarbose.

First described in 2005, it is a rare complication distinct from dumping syndrome, which is common after bypass. For unknown reasons, the pancreas starts to oversecrete insulin in response to even small meals a few months to a few decades after gastric bypass surgery. Until now, treatment has often meant partial or even total pancreatectomy (N. Engl. J. Med. 2005;353:249-54).

“The message from me is very simple: There’s a medical alternative to surgery. Before you take these people to surgery, try medical management,” said Dr. John Mordes, an endocrinologist and professor of medicine at the University of Massachusetts Medical School in Worcester.

The study involved five patients, who were seen there after suddenly developing severe, sometimes daily, postprandial hypoglycemic attacks from 1 to 26 years after Roux-en-Y bypass; several had passed out after meals. On 75-g fasting-glucose challenges, their insulin levels were at or above 17 microU/mL, despite glucose concentrations at or below 54 mg/dL. None of the patients had evidence of insulinomas, and none was on exogenous insulin or diabetes drugs. Their hemoglobin A_1c levels were below 6% (Endocr. Pract. 2015;21:237-46).

The first patient refused surgery, “so we researched the literature” and found that nifedipine helped infants with congenital nesidioblastosis in a study from India. The drug worked at a dose of 30 mg extended release once daily; 30 mg t.i.d. worked in the second patient. Calcium channel blockers blunt insulin secretion, which probably explains why nifedipine helped, Dr. Mordes said at the annual meeting of the American Association of Clinical Endocrinologists.

Both patients stopped taking the pills on their own after about 3 years; their symptoms hadn’t returned after a year or more of follow-up.

The third and fourth patients couldn’t tolerate nifedipine, so Dr. Mordes tried acarbose to slow absorption of glucose from the gut; it also worked. One patient has had only two mild attacks on 50 mg t.i.d for 15 months; the fourth was symptom free while on 25 mg t.i.d for 2 months. That patient stopped the drug at that point, and remained symptom free for 9 more months, but since then has had about one attack a month. The fifth patient has been symptom free for about 6 months on a combination of nifedipine 20 mg t.i.d. and acarbose 50 mg t.i.d, and has no intention of stopping either.

The subjects gained from a few to almost 50 pounds while on the drugs, which might also have contributed to their recovery. Overall, they “are fine now. None of them have needed surgery,” and they’re happy to have avoided it, Dr. Mordes said.

All that’s needed to diagnose the problem is a history of exclusively postprandial symptoms of hypoglycemia with no vasomotor or bowel symptoms suggestive of dumping, plus confirmatory blood work. Invasive tests aren’t necessary, he said.

A sixth patient didn’t respond to nifedipine, acarbose, or the insulinoma drug diazoxide, but she was atypical in that she had a decades-long history of nocturnal hypoglycemic events following a gastric bypass in Mexico at age 13 years for pyloric stenosis. “Something is very different about her,” Dr. Mordes said.

He said he had no relevant financial disclosures, and no outside funding for his work.

[email protected]

NASHVILLE, TENN. – Postprandial hyperinsulinemic hypoglycemia after gastric bypass surgery can be managed or even corrected by medical management with calcium channel blockers or acarbose.

First described in 2005, it is a rare complication distinct from dumping syndrome, which is common after bypass. For unknown reasons, the pancreas starts to oversecrete insulin in response to even small meals a few months to a few decades after gastric bypass surgery. Until now, treatment has often meant partial or even total pancreatectomy (N. Engl. J. Med. 2005;353:249-54).

“The message from me is very simple: There’s a medical alternative to surgery. Before you take these people to surgery, try medical management,” said Dr. John Mordes, an endocrinologist and professor of medicine at the University of Massachusetts Medical School in Worcester.

The study involved five patients, who were seen there after suddenly developing severe, sometimes daily, postprandial hypoglycemic attacks from 1 to 26 years after Roux-en-Y bypass; several had passed out after meals. On 75-g fasting-glucose challenges, their insulin levels were at or above 17 microU/mL, despite glucose concentrations at or below 54 mg/dL. None of the patients had evidence of insulinomas, and none was on exogenous insulin or diabetes drugs. Their hemoglobin A_1c levels were below 6% (Endocr. Pract. 2015;21:237-46).

The first patient refused surgery, “so we researched the literature” and found that nifedipine helped infants with congenital nesidioblastosis in a study from India. The drug worked at a dose of 30 mg extended release once daily; 30 mg t.i.d. worked in the second patient. Calcium channel blockers blunt insulin secretion, which probably explains why nifedipine helped, Dr. Mordes said at the annual meeting of the American Association of Clinical Endocrinologists.

Both patients stopped taking the pills on their own after about 3 years; their symptoms hadn’t returned after a year or more of follow-up.

The third and fourth patients couldn’t tolerate nifedipine, so Dr. Mordes tried acarbose to slow absorption of glucose from the gut; it also worked. One patient has had only two mild attacks on 50 mg t.i.d for 15 months; the fourth was symptom free while on 25 mg t.i.d for 2 months. That patient stopped the drug at that point, and remained symptom free for 9 more months, but since then has had about one attack a month. The fifth patient has been symptom free for about 6 months on a combination of nifedipine 20 mg t.i.d. and acarbose 50 mg t.i.d, and has no intention of stopping either.

The subjects gained from a few to almost 50 pounds while on the drugs, which might also have contributed to their recovery. Overall, they “are fine now. None of them have needed surgery,” and they’re happy to have avoided it, Dr. Mordes said.

All that’s needed to diagnose the problem is a history of exclusively postprandial symptoms of hypoglycemia with no vasomotor or bowel symptoms suggestive of dumping, plus confirmatory blood work. Invasive tests aren’t necessary, he said.

A sixth patient didn’t respond to nifedipine, acarbose, or the insulinoma drug diazoxide, but she was atypical in that she had a decades-long history of nocturnal hypoglycemic events following a gastric bypass in Mexico at age 13 years for pyloric stenosis. “Something is very different about her,” Dr. Mordes said.

He said he had no relevant financial disclosures, and no outside funding for his work.

[email protected]

NASHVILLE, TENN. – Postprandial hyperinsulinemic hypoglycemia after gastric bypass surgery can be managed or even corrected by medical management with calcium channel blockers or acarbose.

First described in 2005, it is a rare complication distinct from dumping syndrome, which is common after bypass. For unknown reasons, the pancreas starts to oversecrete insulin in response to even small meals a few months to a few decades after gastric bypass surgery. Until now, treatment has often meant partial or even total pancreatectomy (N. Engl. J. Med. 2005;353:249-54).

“The message from me is very simple: There’s a medical alternative to surgery. Before you take these people to surgery, try medical management,” said Dr. John Mordes, an endocrinologist and professor of medicine at the University of Massachusetts Medical School in Worcester.

The study involved five patients, who were seen there after suddenly developing severe, sometimes daily, postprandial hypoglycemic attacks from 1 to 26 years after Roux-en-Y bypass; several had passed out after meals. On 75-g fasting-glucose challenges, their insulin levels were at or above 17 microU/mL, despite glucose concentrations at or below 54 mg/dL. None of the patients had evidence of insulinomas, and none was on exogenous insulin or diabetes drugs. Their hemoglobin A_1c levels were below 6% (Endocr. Pract. 2015;21:237-46).

The first patient refused surgery, “so we researched the literature” and found that nifedipine helped infants with congenital nesidioblastosis in a study from India. The drug worked at a dose of 30 mg extended release once daily; 30 mg t.i.d. worked in the second patient. Calcium channel blockers blunt insulin secretion, which probably explains why nifedipine helped, Dr. Mordes said at the annual meeting of the American Association of Clinical Endocrinologists.

Both patients stopped taking the pills on their own after about 3 years; their symptoms hadn’t returned after a year or more of follow-up.

The third and fourth patients couldn’t tolerate nifedipine, so Dr. Mordes tried acarbose to slow absorption of glucose from the gut; it also worked. One patient has had only two mild attacks on 50 mg t.i.d for 15 months; the fourth was symptom free while on 25 mg t.i.d for 2 months. That patient stopped the drug at that point, and remained symptom free for 9 more months, but since then has had about one attack a month. The fifth patient has been symptom free for about 6 months on a combination of nifedipine 20 mg t.i.d. and acarbose 50 mg t.i.d, and has no intention of stopping either.

The subjects gained from a few to almost 50 pounds while on the drugs, which might also have contributed to their recovery. Overall, they “are fine now. None of them have needed surgery,” and they’re happy to have avoided it, Dr. Mordes said.

All that’s needed to diagnose the problem is a history of exclusively postprandial symptoms of hypoglycemia with no vasomotor or bowel symptoms suggestive of dumping, plus confirmatory blood work. Invasive tests aren’t necessary, he said.

A sixth patient didn’t respond to nifedipine, acarbose, or the insulinoma drug diazoxide, but she was atypical in that she had a decades-long history of nocturnal hypoglycemic events following a gastric bypass in Mexico at age 13 years for pyloric stenosis. “Something is very different about her,” Dr. Mordes said.

He said he had no relevant financial disclosures, and no outside funding for his work.

[email protected]