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Study urges better communication between surgeons, elderly patients

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Wed, 01/02/2019 - 08:53
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Study urges better communication between surgeons, elderly patients

Clinicians would better serve their seriously ill elderly patients by improving communication to avoid emergency surgery that could prove to be too intense and potentially harmful, according to a study published online in Annals of Surgery (Ann. Surg. 2014 May 23 [doi: 10.1097/SLA.0000000000000721]).

Dr. Zara Cooper and her colleagues from Brigham and Women’s Hospital, Boston, conducted a wide-ranging literature review to ascertain factors that lead to communication challenges and nonbeneficial surgery at the end of life.

Dr. Zara Cooper

"Elderly patients with serious illness often receive poor-quality end-of-life care, leading to high rates of emergency department use, hospital and intensive care unit admissions, and in-hospital death, and low rates of hospice referral. High-intensity treatments near the end of life often are burdensome and prolong suffering without meeting patients’ personal goals," the researchers wrote.

If surgeons assume that patients favor life-prolonging treatment, they may opt to provide interventions that are immediately lifesaving but add little to the patient’s quality of life and may prolong, or even accelerate, the dying process, the researchers said. Studies have shown that nearly 1 in 10 Medicare patients who die have surgery in the last week of their lives (Lancet 2011;378:1408-13).

"Unable to quickly elucidate the gravity of the underlying illness and assess the patients’ understanding of their disease, surgeons may hesitate to engage in conversations about patient preferences and aggressive palliation as an alternative to invasive treatment," the authors wrote.

To avoid such communication pitfalls, the study recommends:

Advance care planning around surgery: Even in an emergency setting, clinicians can set treatment goals early and revisit them if the patient’s condition deteriorates. Emergency surgeons should engage the patient’s primary and specialty providers whenever possible to participate in clinical decisions.

Education and training: Surgeons routinely encountering seriously ill elderly patients should consider learning evidence-based communication strategies, including how to handle intense emotions, discuss prognosis, and deliver basic palliative-care interventions in a structured format with expert guidance.

Structured communication: The goal is not to divert elderly patients with limited life expectancy from potentially life-prolonging surgery, but instead to determine patients’ priorities up front to better enable surgeons to recommend treatments. Such communication also should determine health states unacceptable to the patient, and affirm the clinician’s commitment to the patient’s well-being.

Further research: More information is needed on patient-centered surgical outcomes for elderly patients with serious illness, including survival beyond 30 days, functional outcomes, health-related quality of life, transitions of care, and quality of death.

According to the study, physicians likely opt for invasive treatment of this vulnerable population out of concern about possible legal repercussions if they withhold it. But even when the patient’s prognosis is clear, legal concerns are minimal, and the patient is willing to discuss death and dying, many surgeons lack training in how to discuss death or provide a palliative approach to care, the researchers said.

Thus, surgeons may fail to respond to social cues relevant to end-of-life care or provide support, and instead "frequently employ defensive strategies" such as focusing on medical details, the study found.

Patients in distress often rely on surrogate decision-makers, the researchers noted. Given the disconnect between surrogates’ expectations and what medical treatment realistically can offer, surrogates may consent to treatments that they believe will prolong and restore quality of life when in fact such interventions are associated with physical or psychological suffering and scant, if any, benefit.

The authors did not receive funding support for this work and declared no conflicts of interest.

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Clinicians would better serve their seriously ill elderly patients by improving communication to avoid emergency surgery that could prove to be too intense and potentially harmful, according to a study published online in Annals of Surgery (Ann. Surg. 2014 May 23 [doi: 10.1097/SLA.0000000000000721]).

Dr. Zara Cooper and her colleagues from Brigham and Women’s Hospital, Boston, conducted a wide-ranging literature review to ascertain factors that lead to communication challenges and nonbeneficial surgery at the end of life.

Dr. Zara Cooper

"Elderly patients with serious illness often receive poor-quality end-of-life care, leading to high rates of emergency department use, hospital and intensive care unit admissions, and in-hospital death, and low rates of hospice referral. High-intensity treatments near the end of life often are burdensome and prolong suffering without meeting patients’ personal goals," the researchers wrote.

If surgeons assume that patients favor life-prolonging treatment, they may opt to provide interventions that are immediately lifesaving but add little to the patient’s quality of life and may prolong, or even accelerate, the dying process, the researchers said. Studies have shown that nearly 1 in 10 Medicare patients who die have surgery in the last week of their lives (Lancet 2011;378:1408-13).

"Unable to quickly elucidate the gravity of the underlying illness and assess the patients’ understanding of their disease, surgeons may hesitate to engage in conversations about patient preferences and aggressive palliation as an alternative to invasive treatment," the authors wrote.

To avoid such communication pitfalls, the study recommends:

Advance care planning around surgery: Even in an emergency setting, clinicians can set treatment goals early and revisit them if the patient’s condition deteriorates. Emergency surgeons should engage the patient’s primary and specialty providers whenever possible to participate in clinical decisions.

Education and training: Surgeons routinely encountering seriously ill elderly patients should consider learning evidence-based communication strategies, including how to handle intense emotions, discuss prognosis, and deliver basic palliative-care interventions in a structured format with expert guidance.

Structured communication: The goal is not to divert elderly patients with limited life expectancy from potentially life-prolonging surgery, but instead to determine patients’ priorities up front to better enable surgeons to recommend treatments. Such communication also should determine health states unacceptable to the patient, and affirm the clinician’s commitment to the patient’s well-being.

Further research: More information is needed on patient-centered surgical outcomes for elderly patients with serious illness, including survival beyond 30 days, functional outcomes, health-related quality of life, transitions of care, and quality of death.

According to the study, physicians likely opt for invasive treatment of this vulnerable population out of concern about possible legal repercussions if they withhold it. But even when the patient’s prognosis is clear, legal concerns are minimal, and the patient is willing to discuss death and dying, many surgeons lack training in how to discuss death or provide a palliative approach to care, the researchers said.

Thus, surgeons may fail to respond to social cues relevant to end-of-life care or provide support, and instead "frequently employ defensive strategies" such as focusing on medical details, the study found.

Patients in distress often rely on surrogate decision-makers, the researchers noted. Given the disconnect between surrogates’ expectations and what medical treatment realistically can offer, surrogates may consent to treatments that they believe will prolong and restore quality of life when in fact such interventions are associated with physical or psychological suffering and scant, if any, benefit.

The authors did not receive funding support for this work and declared no conflicts of interest.

Clinicians would better serve their seriously ill elderly patients by improving communication to avoid emergency surgery that could prove to be too intense and potentially harmful, according to a study published online in Annals of Surgery (Ann. Surg. 2014 May 23 [doi: 10.1097/SLA.0000000000000721]).

Dr. Zara Cooper and her colleagues from Brigham and Women’s Hospital, Boston, conducted a wide-ranging literature review to ascertain factors that lead to communication challenges and nonbeneficial surgery at the end of life.

Dr. Zara Cooper

"Elderly patients with serious illness often receive poor-quality end-of-life care, leading to high rates of emergency department use, hospital and intensive care unit admissions, and in-hospital death, and low rates of hospice referral. High-intensity treatments near the end of life often are burdensome and prolong suffering without meeting patients’ personal goals," the researchers wrote.

If surgeons assume that patients favor life-prolonging treatment, they may opt to provide interventions that are immediately lifesaving but add little to the patient’s quality of life and may prolong, or even accelerate, the dying process, the researchers said. Studies have shown that nearly 1 in 10 Medicare patients who die have surgery in the last week of their lives (Lancet 2011;378:1408-13).

"Unable to quickly elucidate the gravity of the underlying illness and assess the patients’ understanding of their disease, surgeons may hesitate to engage in conversations about patient preferences and aggressive palliation as an alternative to invasive treatment," the authors wrote.

To avoid such communication pitfalls, the study recommends:

Advance care planning around surgery: Even in an emergency setting, clinicians can set treatment goals early and revisit them if the patient’s condition deteriorates. Emergency surgeons should engage the patient’s primary and specialty providers whenever possible to participate in clinical decisions.

Education and training: Surgeons routinely encountering seriously ill elderly patients should consider learning evidence-based communication strategies, including how to handle intense emotions, discuss prognosis, and deliver basic palliative-care interventions in a structured format with expert guidance.

Structured communication: The goal is not to divert elderly patients with limited life expectancy from potentially life-prolonging surgery, but instead to determine patients’ priorities up front to better enable surgeons to recommend treatments. Such communication also should determine health states unacceptable to the patient, and affirm the clinician’s commitment to the patient’s well-being.

Further research: More information is needed on patient-centered surgical outcomes for elderly patients with serious illness, including survival beyond 30 days, functional outcomes, health-related quality of life, transitions of care, and quality of death.

According to the study, physicians likely opt for invasive treatment of this vulnerable population out of concern about possible legal repercussions if they withhold it. But even when the patient’s prognosis is clear, legal concerns are minimal, and the patient is willing to discuss death and dying, many surgeons lack training in how to discuss death or provide a palliative approach to care, the researchers said.

Thus, surgeons may fail to respond to social cues relevant to end-of-life care or provide support, and instead "frequently employ defensive strategies" such as focusing on medical details, the study found.

Patients in distress often rely on surrogate decision-makers, the researchers noted. Given the disconnect between surrogates’ expectations and what medical treatment realistically can offer, surrogates may consent to treatments that they believe will prolong and restore quality of life when in fact such interventions are associated with physical or psychological suffering and scant, if any, benefit.

The authors did not receive funding support for this work and declared no conflicts of interest.

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Tests pinpoint primary sources of neuroendocrine bowel, pancreatic metastases

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Tests pinpoint primary sources of neuroendocrine bowel, pancreatic metastases

BOSTON – With a little chemical or genetic snooping, or both, clinicians may be able to pinpoint the source of nearly all metastatic neuroendocrine tumors of the small bowel or pancreas.

By looking at expression patterns of four genes, investigators were able to determine that a surgically obtained metastatic neuroendocrine tumor (NET) originated in the small bowel with more than 96% accuracy, and, with the use of an immunohistochemistry algorithm, they identified the pancreas as the primary source of metastases in 10 of 10 cases.

"All the NETs that were misclassified by one method were correctly identified by the other method," said Dr. Jessica Maxwell of the department of surgery at the University of Iowa Hospitals and Clinics in Iowa City.

In about 15%-20% of cases of metastatic NETs, the primary tumor site is unknown, but is most likely to be in the small bowel or pancreas. Failure to identify the primary tumor site, despite optimal work-up, could delay referral for surgery or complicate choice of systemic medical therapies, she said at the annual meeting of the American Association of Endocrine Surgeons.

The authors tested the mettle of immunohistochemistry and gene expression classification (GEC) methods on 136 metastatic NETs collected intraoperatively from 97 patients with small-bowel NETs (38 with metastases to liver and 59 with metastases to lymph nodes) and 39 with pancreatic NETs (17 liver and 22 lymph node metastases).

The GEC uses quantitative or "real-time" polymerase chain reaction (qPCR) to evaluate expression of four key genes, encoding for the secretin receptor (SCTR), oxytocin receptor (OXTR), bombesin-like receptor-3 (BRS3), and opioid receptor kappa-1 (OPRK1).

The differential patterns of gene expression mark the metastases as originating either in the pancreas or small bowel.

They also tested a two-tiered immunohistochemistry algorithm using the markers CDX2, PAX6, and ISLET1 for tier 1, and PrAP, PRm NESP55, and PDX1 in tier 2. They tested the algorithm on six primary tumors and validated their findings on 37 metastases.

The immunohistochemistry method can identify a primary tumor site with as few as three markers, but if the findings are indeterminate, the addition of the four tier 2 markers can help to nail down the tumor site, Dr. Maxwell said.

They found that the GEC accurately identified 94 of 97 small bowel NETs (96.9%), and 34 of 39 pancreatic NETS (87.2%).

In contrast, the immunohistochemistry algorithm correctly identified the primary site in 23 of 27 small bowel metastases (85.2%), and in 10 of 10 (100%) pancreatic metastases.

When the methods were compared head to head in 27 metastases, GEC had a 96.2% overall accuracy and immunohistochemistry an 85.2% accuracy.

As noted before, the methods were complementary, with all NETs misclassified by one method called accurately by the other.

The investigators suggest that because the methods are highly accurate and complementary, they may best be used sequentially, starting with immunohistochemistry which is both inexpensive and widely available, and if immunohistochemistry fails, moving on to GEC.

"Sequential use allows for identification of nearly all metastatic neuroendocrine tumors from small bowel or pancreatic sites," Dr. Maxwell said.

In the discussion, Dr. Eren Berber of the Center for Endocrine Surgery at the Cleveland Clinic, who was not involved in the study, questioned whether knowing the primary site had any practical implications for surgeons.

Dr. Maxwell noted that some pancreatic NETs are not detected by preoperative studies and that given the risks of pancreatectomy or pancreaticoduodenectomy, accurately identifying the source of an NET may be helpful for patient counseling and preoperative planning.

The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.

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BOSTON – With a little chemical or genetic snooping, or both, clinicians may be able to pinpoint the source of nearly all metastatic neuroendocrine tumors of the small bowel or pancreas.

By looking at expression patterns of four genes, investigators were able to determine that a surgically obtained metastatic neuroendocrine tumor (NET) originated in the small bowel with more than 96% accuracy, and, with the use of an immunohistochemistry algorithm, they identified the pancreas as the primary source of metastases in 10 of 10 cases.

"All the NETs that were misclassified by one method were correctly identified by the other method," said Dr. Jessica Maxwell of the department of surgery at the University of Iowa Hospitals and Clinics in Iowa City.

In about 15%-20% of cases of metastatic NETs, the primary tumor site is unknown, but is most likely to be in the small bowel or pancreas. Failure to identify the primary tumor site, despite optimal work-up, could delay referral for surgery or complicate choice of systemic medical therapies, she said at the annual meeting of the American Association of Endocrine Surgeons.

The authors tested the mettle of immunohistochemistry and gene expression classification (GEC) methods on 136 metastatic NETs collected intraoperatively from 97 patients with small-bowel NETs (38 with metastases to liver and 59 with metastases to lymph nodes) and 39 with pancreatic NETs (17 liver and 22 lymph node metastases).

The GEC uses quantitative or "real-time" polymerase chain reaction (qPCR) to evaluate expression of four key genes, encoding for the secretin receptor (SCTR), oxytocin receptor (OXTR), bombesin-like receptor-3 (BRS3), and opioid receptor kappa-1 (OPRK1).

The differential patterns of gene expression mark the metastases as originating either in the pancreas or small bowel.

They also tested a two-tiered immunohistochemistry algorithm using the markers CDX2, PAX6, and ISLET1 for tier 1, and PrAP, PRm NESP55, and PDX1 in tier 2. They tested the algorithm on six primary tumors and validated their findings on 37 metastases.

The immunohistochemistry method can identify a primary tumor site with as few as three markers, but if the findings are indeterminate, the addition of the four tier 2 markers can help to nail down the tumor site, Dr. Maxwell said.

They found that the GEC accurately identified 94 of 97 small bowel NETs (96.9%), and 34 of 39 pancreatic NETS (87.2%).

In contrast, the immunohistochemistry algorithm correctly identified the primary site in 23 of 27 small bowel metastases (85.2%), and in 10 of 10 (100%) pancreatic metastases.

When the methods were compared head to head in 27 metastases, GEC had a 96.2% overall accuracy and immunohistochemistry an 85.2% accuracy.

As noted before, the methods were complementary, with all NETs misclassified by one method called accurately by the other.

The investigators suggest that because the methods are highly accurate and complementary, they may best be used sequentially, starting with immunohistochemistry which is both inexpensive and widely available, and if immunohistochemistry fails, moving on to GEC.

"Sequential use allows for identification of nearly all metastatic neuroendocrine tumors from small bowel or pancreatic sites," Dr. Maxwell said.

In the discussion, Dr. Eren Berber of the Center for Endocrine Surgery at the Cleveland Clinic, who was not involved in the study, questioned whether knowing the primary site had any practical implications for surgeons.

Dr. Maxwell noted that some pancreatic NETs are not detected by preoperative studies and that given the risks of pancreatectomy or pancreaticoduodenectomy, accurately identifying the source of an NET may be helpful for patient counseling and preoperative planning.

The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.

BOSTON – With a little chemical or genetic snooping, or both, clinicians may be able to pinpoint the source of nearly all metastatic neuroendocrine tumors of the small bowel or pancreas.

By looking at expression patterns of four genes, investigators were able to determine that a surgically obtained metastatic neuroendocrine tumor (NET) originated in the small bowel with more than 96% accuracy, and, with the use of an immunohistochemistry algorithm, they identified the pancreas as the primary source of metastases in 10 of 10 cases.

"All the NETs that were misclassified by one method were correctly identified by the other method," said Dr. Jessica Maxwell of the department of surgery at the University of Iowa Hospitals and Clinics in Iowa City.

In about 15%-20% of cases of metastatic NETs, the primary tumor site is unknown, but is most likely to be in the small bowel or pancreas. Failure to identify the primary tumor site, despite optimal work-up, could delay referral for surgery or complicate choice of systemic medical therapies, she said at the annual meeting of the American Association of Endocrine Surgeons.

The authors tested the mettle of immunohistochemistry and gene expression classification (GEC) methods on 136 metastatic NETs collected intraoperatively from 97 patients with small-bowel NETs (38 with metastases to liver and 59 with metastases to lymph nodes) and 39 with pancreatic NETs (17 liver and 22 lymph node metastases).

The GEC uses quantitative or "real-time" polymerase chain reaction (qPCR) to evaluate expression of four key genes, encoding for the secretin receptor (SCTR), oxytocin receptor (OXTR), bombesin-like receptor-3 (BRS3), and opioid receptor kappa-1 (OPRK1).

The differential patterns of gene expression mark the metastases as originating either in the pancreas or small bowel.

They also tested a two-tiered immunohistochemistry algorithm using the markers CDX2, PAX6, and ISLET1 for tier 1, and PrAP, PRm NESP55, and PDX1 in tier 2. They tested the algorithm on six primary tumors and validated their findings on 37 metastases.

The immunohistochemistry method can identify a primary tumor site with as few as three markers, but if the findings are indeterminate, the addition of the four tier 2 markers can help to nail down the tumor site, Dr. Maxwell said.

They found that the GEC accurately identified 94 of 97 small bowel NETs (96.9%), and 34 of 39 pancreatic NETS (87.2%).

In contrast, the immunohistochemistry algorithm correctly identified the primary site in 23 of 27 small bowel metastases (85.2%), and in 10 of 10 (100%) pancreatic metastases.

When the methods were compared head to head in 27 metastases, GEC had a 96.2% overall accuracy and immunohistochemistry an 85.2% accuracy.

As noted before, the methods were complementary, with all NETs misclassified by one method called accurately by the other.

The investigators suggest that because the methods are highly accurate and complementary, they may best be used sequentially, starting with immunohistochemistry which is both inexpensive and widely available, and if immunohistochemistry fails, moving on to GEC.

"Sequential use allows for identification of nearly all metastatic neuroendocrine tumors from small bowel or pancreatic sites," Dr. Maxwell said.

In the discussion, Dr. Eren Berber of the Center for Endocrine Surgery at the Cleveland Clinic, who was not involved in the study, questioned whether knowing the primary site had any practical implications for surgeons.

Dr. Maxwell noted that some pancreatic NETs are not detected by preoperative studies and that given the risks of pancreatectomy or pancreaticoduodenectomy, accurately identifying the source of an NET may be helpful for patient counseling and preoperative planning.

The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.

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Key clinical point: Gene expression can be used to identify the primary source of neuroendocrine small bowel and pancreatic metastases.

Major finding: Gene expression classification accurately identified the primary source of 94 of 97 small bowel neuroendocrine tumor metastases, (96.9%), and 34 of 39 pancreatic metastases (87.2%).

Data source: Retrospective single institution study of metastases from 136 patients with neuroendocrine tumors.

Disclosures: The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.

Midurethral sling study: At 5 years satisfaction remained high, though continence declined

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Midurethral sling study: At 5 years satisfaction remained high, though continence declined

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

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ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

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Key clinical point: The benefits of midurethral slings persisted 5 years in the majority of women.

Major finding: Overall rates of satisfaction at 5 years were 79% and 85% with retropubic midurethral and transobturator midurethral slings, respectively.

Data source: Extended follow-up of 404 patients from the TOMUS trial (E-TOMUS).

Disclosures: This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

Bariatric surgery found to reduce risk of AF in morbidly obese patients

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SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m2, respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

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SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m2, respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m2, respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

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Key clinical point: Weight loss achieved through bariatric surgery may prevent atrial fibrillation in morbidly obese patients.

Major finding: After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of morbidly obese patients who underwent bariatric surgery, compared with 12.5% of their counterparts who were treated medically, a statistically significant difference.

Data source: Retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery.

Disclosures: The researchers reported no financial conflicts of interest.

ACA exchange plans present reimbursement challenges

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Physicians face a number of new hurdles in getting paid for the care they provide to patients covered by the Affordable Care Act’s health care marketplace plans.

Texas physicians are reporting difficulties in getting information on patients’ coverage from exchange plans, as well as a lack of understanding from patients about their coverage and financial responsibilities, according to Dr. Austin King, president of the Texas Medical Association and an otolaryngologist in Abilene.

Dr. Austin King

Without this information, it is difficult to have a clear conversation about what patients will owe out of pocket, Dr. King said, adding that patients have a steep learning curve when it comes to the marketplace plans. "It’s a matter of educating patients as to what to expect from these policies."

Another looming problem: The 90-day "grace period" for plan members who have not paid their premiums. During the first 30 days of the grace period, plans must pay claims, but for the next 60 days, they can withhold payment, and if a policy is canceled because of nonpayment of premiums, plans are not required to pay physicians for claims.

Dr. King noted that in Texas, some plans are refusing to pay claims in that 60-day period. However, the single statewide carrier, a Blue Cross Blue Shield plan, is paying claims during the final 60 days of the grace period, but will seek to recoup payments made to physicians if coverage is canceled because of premium nonpayment.

The severity of this problem is not yet known, Dr. King said, but "it will be interesting to see how this impacts the bottom line," particularly for primary care doctors, who he expects to be more severely impacted than specialists.

Dr. King’s observations mirror the results of a recent survey by the Medical Group Management Association.

More than half (60%) of respondents to an April survey said that they believe that the ACA marketplaces will have a "very unfavorable" or "unfavorable" impact on their practices. Nearly 94% have seen patients with marketplace coverage.

Half of respondents said that payment rates offered by the marketplace plans are either "much lower" or "somewhat lower" than those offered by traditional commercial contracts. A little less than half (46%) said the rates are "much lower" or "somewhat lower" than other traditional products offered by the same payer.

The majority of respondents reported having a "somewhat more difficult" or "much more difficult" experience with marketplace plans in verifying patient eligibility (63%), obtaining cost-sharing information (62%), and obtaining provider network information to facilitate referrals (57%).

It is that difficulty in obtaining information that is driving the dissatisfaction in dealing with ACA marketplace plans, said Anders Gilberg, senior vice president of government affairs at MGMA. He added that practices are hiring staff just to deal with getting information from exchange plans.

The MGMA survey gleaned responses from 728 medical groups composed of more than 40,000 physicians nationwide.

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Physicians face a number of new hurdles in getting paid for the care they provide to patients covered by the Affordable Care Act’s health care marketplace plans.

Texas physicians are reporting difficulties in getting information on patients’ coverage from exchange plans, as well as a lack of understanding from patients about their coverage and financial responsibilities, according to Dr. Austin King, president of the Texas Medical Association and an otolaryngologist in Abilene.

Dr. Austin King

Without this information, it is difficult to have a clear conversation about what patients will owe out of pocket, Dr. King said, adding that patients have a steep learning curve when it comes to the marketplace plans. "It’s a matter of educating patients as to what to expect from these policies."

Another looming problem: The 90-day "grace period" for plan members who have not paid their premiums. During the first 30 days of the grace period, plans must pay claims, but for the next 60 days, they can withhold payment, and if a policy is canceled because of nonpayment of premiums, plans are not required to pay physicians for claims.

Dr. King noted that in Texas, some plans are refusing to pay claims in that 60-day period. However, the single statewide carrier, a Blue Cross Blue Shield plan, is paying claims during the final 60 days of the grace period, but will seek to recoup payments made to physicians if coverage is canceled because of premium nonpayment.

The severity of this problem is not yet known, Dr. King said, but "it will be interesting to see how this impacts the bottom line," particularly for primary care doctors, who he expects to be more severely impacted than specialists.

Dr. King’s observations mirror the results of a recent survey by the Medical Group Management Association.

More than half (60%) of respondents to an April survey said that they believe that the ACA marketplaces will have a "very unfavorable" or "unfavorable" impact on their practices. Nearly 94% have seen patients with marketplace coverage.

Half of respondents said that payment rates offered by the marketplace plans are either "much lower" or "somewhat lower" than those offered by traditional commercial contracts. A little less than half (46%) said the rates are "much lower" or "somewhat lower" than other traditional products offered by the same payer.

The majority of respondents reported having a "somewhat more difficult" or "much more difficult" experience with marketplace plans in verifying patient eligibility (63%), obtaining cost-sharing information (62%), and obtaining provider network information to facilitate referrals (57%).

It is that difficulty in obtaining information that is driving the dissatisfaction in dealing with ACA marketplace plans, said Anders Gilberg, senior vice president of government affairs at MGMA. He added that practices are hiring staff just to deal with getting information from exchange plans.

The MGMA survey gleaned responses from 728 medical groups composed of more than 40,000 physicians nationwide.

[email protected]

Physicians face a number of new hurdles in getting paid for the care they provide to patients covered by the Affordable Care Act’s health care marketplace plans.

Texas physicians are reporting difficulties in getting information on patients’ coverage from exchange plans, as well as a lack of understanding from patients about their coverage and financial responsibilities, according to Dr. Austin King, president of the Texas Medical Association and an otolaryngologist in Abilene.

Dr. Austin King

Without this information, it is difficult to have a clear conversation about what patients will owe out of pocket, Dr. King said, adding that patients have a steep learning curve when it comes to the marketplace plans. "It’s a matter of educating patients as to what to expect from these policies."

Another looming problem: The 90-day "grace period" for plan members who have not paid their premiums. During the first 30 days of the grace period, plans must pay claims, but for the next 60 days, they can withhold payment, and if a policy is canceled because of nonpayment of premiums, plans are not required to pay physicians for claims.

Dr. King noted that in Texas, some plans are refusing to pay claims in that 60-day period. However, the single statewide carrier, a Blue Cross Blue Shield plan, is paying claims during the final 60 days of the grace period, but will seek to recoup payments made to physicians if coverage is canceled because of premium nonpayment.

The severity of this problem is not yet known, Dr. King said, but "it will be interesting to see how this impacts the bottom line," particularly for primary care doctors, who he expects to be more severely impacted than specialists.

Dr. King’s observations mirror the results of a recent survey by the Medical Group Management Association.

More than half (60%) of respondents to an April survey said that they believe that the ACA marketplaces will have a "very unfavorable" or "unfavorable" impact on their practices. Nearly 94% have seen patients with marketplace coverage.

Half of respondents said that payment rates offered by the marketplace plans are either "much lower" or "somewhat lower" than those offered by traditional commercial contracts. A little less than half (46%) said the rates are "much lower" or "somewhat lower" than other traditional products offered by the same payer.

The majority of respondents reported having a "somewhat more difficult" or "much more difficult" experience with marketplace plans in verifying patient eligibility (63%), obtaining cost-sharing information (62%), and obtaining provider network information to facilitate referrals (57%).

It is that difficulty in obtaining information that is driving the dissatisfaction in dealing with ACA marketplace plans, said Anders Gilberg, senior vice president of government affairs at MGMA. He added that practices are hiring staff just to deal with getting information from exchange plans.

The MGMA survey gleaned responses from 728 medical groups composed of more than 40,000 physicians nationwide.

[email protected]

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Burwell confirmed as HHS secretary

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Sylvia Mathews Burwell is the new secretary of the Department of Health & Human Services and the de facto face of the controversial Affordable Care Act.

On June 5, the Senate voted 78-17 to confirm Ms. Burwell to lead HHS. Her nomination garnered a good deal of bipartisan support, with several GOP senators praising her competence. However, several Republicans refused to vote for the West Virginia native because of their opposition to the ACA, including Senate Minority Leader Mitch McConnell (R-Ky.).

"By most accounts, Sylvia Burwell is a smart and skilled public servant. But her embrace of Obamacare calls her policy judgment into question," Sen. McConnell said on the floor of the Senate. "And when it comes to the task of implementing this ill-conceived and disastrous law, the president may as well have nominated Sisyphus. Because, as I indicated, Ms. Burwell is being asked to do the impossible here."

Alicia Ault/Frontline Medical News
Sylvia Mathews Burwell at her confirmation hearing to be the next HHS secretary.

On April 11, President Obama nominated Ms. Burwell, then director of the Office of Management and Budget, to replace outgoing HHS Secretary Kathleen Sebelius whose 5-year tenure at HHS was marred by the rocky rollout of healthcare.gov.

During two Senate confirmation hearings, Ms. Burwell gave a glimpse of how she will approach the job at HHS.

When asked about her approach to employing the controversial Independent Payment Advisory Board, Ms. Burwell said she hopes that it will never be triggered because the government will keep health care costs under control.

In addressing the mishandled rollout of healthcare.gov, Ms. Burwell said learned that there needs to be a different approach to handling information technology procurement and delivery. She pledged to ensure there was "ownership and accountability" in the IT operations in the future.

She also promised GOP senators that she would share information with them.

Ms. Burwell, a Rhodes Scholar from Hinton, W.Va., previously served as president of the Walmart Foundation and as president of the global development program at the Bill & Melinda Gates Foundation. During the Clinton administration, she was deputy director of the Office of Management and Budget.

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Sylvia Mathews Burwell is the new secretary of the Department of Health & Human Services and the de facto face of the controversial Affordable Care Act.

On June 5, the Senate voted 78-17 to confirm Ms. Burwell to lead HHS. Her nomination garnered a good deal of bipartisan support, with several GOP senators praising her competence. However, several Republicans refused to vote for the West Virginia native because of their opposition to the ACA, including Senate Minority Leader Mitch McConnell (R-Ky.).

"By most accounts, Sylvia Burwell is a smart and skilled public servant. But her embrace of Obamacare calls her policy judgment into question," Sen. McConnell said on the floor of the Senate. "And when it comes to the task of implementing this ill-conceived and disastrous law, the president may as well have nominated Sisyphus. Because, as I indicated, Ms. Burwell is being asked to do the impossible here."

Alicia Ault/Frontline Medical News
Sylvia Mathews Burwell at her confirmation hearing to be the next HHS secretary.

On April 11, President Obama nominated Ms. Burwell, then director of the Office of Management and Budget, to replace outgoing HHS Secretary Kathleen Sebelius whose 5-year tenure at HHS was marred by the rocky rollout of healthcare.gov.

During two Senate confirmation hearings, Ms. Burwell gave a glimpse of how she will approach the job at HHS.

When asked about her approach to employing the controversial Independent Payment Advisory Board, Ms. Burwell said she hopes that it will never be triggered because the government will keep health care costs under control.

In addressing the mishandled rollout of healthcare.gov, Ms. Burwell said learned that there needs to be a different approach to handling information technology procurement and delivery. She pledged to ensure there was "ownership and accountability" in the IT operations in the future.

She also promised GOP senators that she would share information with them.

Ms. Burwell, a Rhodes Scholar from Hinton, W.Va., previously served as president of the Walmart Foundation and as president of the global development program at the Bill & Melinda Gates Foundation. During the Clinton administration, she was deputy director of the Office of Management and Budget.

[email protected]

On Twitter @maryellenny

Sylvia Mathews Burwell is the new secretary of the Department of Health & Human Services and the de facto face of the controversial Affordable Care Act.

On June 5, the Senate voted 78-17 to confirm Ms. Burwell to lead HHS. Her nomination garnered a good deal of bipartisan support, with several GOP senators praising her competence. However, several Republicans refused to vote for the West Virginia native because of their opposition to the ACA, including Senate Minority Leader Mitch McConnell (R-Ky.).

"By most accounts, Sylvia Burwell is a smart and skilled public servant. But her embrace of Obamacare calls her policy judgment into question," Sen. McConnell said on the floor of the Senate. "And when it comes to the task of implementing this ill-conceived and disastrous law, the president may as well have nominated Sisyphus. Because, as I indicated, Ms. Burwell is being asked to do the impossible here."

Alicia Ault/Frontline Medical News
Sylvia Mathews Burwell at her confirmation hearing to be the next HHS secretary.

On April 11, President Obama nominated Ms. Burwell, then director of the Office of Management and Budget, to replace outgoing HHS Secretary Kathleen Sebelius whose 5-year tenure at HHS was marred by the rocky rollout of healthcare.gov.

During two Senate confirmation hearings, Ms. Burwell gave a glimpse of how she will approach the job at HHS.

When asked about her approach to employing the controversial Independent Payment Advisory Board, Ms. Burwell said she hopes that it will never be triggered because the government will keep health care costs under control.

In addressing the mishandled rollout of healthcare.gov, Ms. Burwell said learned that there needs to be a different approach to handling information technology procurement and delivery. She pledged to ensure there was "ownership and accountability" in the IT operations in the future.

She also promised GOP senators that she would share information with them.

Ms. Burwell, a Rhodes Scholar from Hinton, W.Va., previously served as president of the Walmart Foundation and as president of the global development program at the Bill & Melinda Gates Foundation. During the Clinton administration, she was deputy director of the Office of Management and Budget.

[email protected]

On Twitter @maryellenny

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ICD-10 delay: Proceed with caution, experts advise

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When it comes to ICD-10 readiness, invest in low-cost, high-impact steps that will benefit the October 2015 switch to new code set, but will also improve the general health of the medical practice.

Now that implementation of ICD-10 has been delayed a full year, "I’d avoid spending too much money at this stage," said Robert Tennant, senior policy advisor at the Medical Group Management Association (MGMA).

Practical steps include checking claims already paid under ICD-9 to see whether the documentation was sufficient to assign an ICD-10 code. In the case of a sprained wrist, for example, make sure the documentation includes whether the injury was to the left or right wrist, Mr. Tennant said.

Robert M. Tennant

Consider dual coding – coding the same claims in both ICD-9 and ICD-10 – for some most commonly used codes, Mr. Tennant advised. If you "go through the clinical documentation improvement exercises, you will produce a better quality medical record and that can help the practice in a number of ways even if ICD-10 never goes forward."

Other low-cost, high-impact steps include reaching out to clearinghouses to request reports on the practice’s top diagnosis codes, the top pended or rejected claims, and the most frequently used unspecified codes.

"That should really focus the practice in on those claims that are the most problematic," he said.

One tough decision is when to upgrade software. Upgrade too early and the practice could lose money if there’s another delay. Wait too long and the practice risks being unprepared for the compliance date, Mr. Tennant said.

He advised finding out when the vendor will be ready with upgrades and how long it will take them to install the software and provide training. Use that to build an implementation timeline.

"It’s such a tightrope that practices have to walk," Mr. Tennant said.

Dallas-based pediatrician Joseph Schneider has been helping physicians prepare for ICD-10 in his role as chair of the Texas Medical Association’s Practice Management Services Council. The association’s official policy is that the move to ICD-10 should be scrapped, but the group is urging physicians and hospitals to prepare anyway.

Dr. Schneider said smaller practices should check in with payers, vendors, and clearinghouses now, but save significant investments and training for next year.

"If you’re in a small physician practice, probably doing not very much between now and December might be a pretty good strategy," he said. "From January forward, you have to start your engines and get everything ready."

But larger practices and health systems don’t have the luxury of waiting, he said.

Dr. George Abraham

Dr. George Abraham, who is part of a six-physician practice in Worcester, Mass., was ready for ICD-10 to take effect this year. His practice spent more than $25,000 preparing for the scheduled switch and had done some initial testing of systems when the delay was announced.

Now the practice faces an additional expenditure on upgrades and refresher courses for coders and physicians.

"After everything, poof, it’s gone in a puff of smoke because everything came to a standstill when ICD-10 got suspended for a year," said Dr. Abraham, governor of the Massachusetts chapter of the American College of Physicians. "It will be déjà vu all over again come summer of next year. We’ll be doing the same thing in preparation for ICD-10 being rolled out in October 2015."

Most health plans won’t begin end-to-end testing of claims until next year, Dr. Abraham said, and that’s worrisome because it may not provide enough time to work out potential glitches.

"A delay in claims being processed is our biggest anxiety," he said. "A delay in payments will lead to a severe cash flow crunch."

Waiting on the CMS for ICD-10 details

Few details have emerged from the Centers for Medicare & Medicaid Services since Congress delayed the implementation of the ICD-10 coding system earlier this year.

As part of Protecting Access to Medicare Act of 2014 (H.R. 4302), Congress delayed implementation of ICD-10 for at least a year. In May, CMS officials announced that the new compliance date would be Oct. 1, 2015, and that physicians and hospitals must continue to use ICD-9 through Sept. 30, 2015.

The agency said it would release an interim final rule in the "near future" with additional details about the compliance date.

Since then, the CMS canceled the end-to-end system testing that had been scheduled for July. The testing will be held sometime in 2015 instead, according to the agency.

But the CMS did report on results of acknowledgement testing conducted with Medicare fee-for-service contractors in March. During the test, providers, suppliers, billing companies, and clearinghouses sent more than 127,000 claims with ICD-10 codes to the Medicare fee-for-service claims system. They received an electronic acknowledgement if their claims were accepted. The exercise did not test whether the claims test had sufficient documentation to be paid by Medicare.

 

 

Overall, the CMS accepted 89% of the test claims, below the normal average Medicare claims acceptance rates of 95% to 98%.

Negative testing – the purposeful submission of error-filled claims to force a rejection – could be one reason for the lower acceptance rate, according to Niall Brennan, acting director of the CMS Offices of Enterprise Management.

While physicians and other providers can submit claims for acknowledgement testing anytime up to the implementation date, Mr. Brennan recommended waiting until after Oct. 6, 2014, when Medicare updates its systems.

Physicians should contact their local Medicare Administrative Contractor for information on acknowledgement testing, according to the CMS.

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When it comes to ICD-10 readiness, invest in low-cost, high-impact steps that will benefit the October 2015 switch to new code set, but will also improve the general health of the medical practice.

Now that implementation of ICD-10 has been delayed a full year, "I’d avoid spending too much money at this stage," said Robert Tennant, senior policy advisor at the Medical Group Management Association (MGMA).

Practical steps include checking claims already paid under ICD-9 to see whether the documentation was sufficient to assign an ICD-10 code. In the case of a sprained wrist, for example, make sure the documentation includes whether the injury was to the left or right wrist, Mr. Tennant said.

Robert M. Tennant

Consider dual coding – coding the same claims in both ICD-9 and ICD-10 – for some most commonly used codes, Mr. Tennant advised. If you "go through the clinical documentation improvement exercises, you will produce a better quality medical record and that can help the practice in a number of ways even if ICD-10 never goes forward."

Other low-cost, high-impact steps include reaching out to clearinghouses to request reports on the practice’s top diagnosis codes, the top pended or rejected claims, and the most frequently used unspecified codes.

"That should really focus the practice in on those claims that are the most problematic," he said.

One tough decision is when to upgrade software. Upgrade too early and the practice could lose money if there’s another delay. Wait too long and the practice risks being unprepared for the compliance date, Mr. Tennant said.

He advised finding out when the vendor will be ready with upgrades and how long it will take them to install the software and provide training. Use that to build an implementation timeline.

"It’s such a tightrope that practices have to walk," Mr. Tennant said.

Dallas-based pediatrician Joseph Schneider has been helping physicians prepare for ICD-10 in his role as chair of the Texas Medical Association’s Practice Management Services Council. The association’s official policy is that the move to ICD-10 should be scrapped, but the group is urging physicians and hospitals to prepare anyway.

Dr. Schneider said smaller practices should check in with payers, vendors, and clearinghouses now, but save significant investments and training for next year.

"If you’re in a small physician practice, probably doing not very much between now and December might be a pretty good strategy," he said. "From January forward, you have to start your engines and get everything ready."

But larger practices and health systems don’t have the luxury of waiting, he said.

Dr. George Abraham

Dr. George Abraham, who is part of a six-physician practice in Worcester, Mass., was ready for ICD-10 to take effect this year. His practice spent more than $25,000 preparing for the scheduled switch and had done some initial testing of systems when the delay was announced.

Now the practice faces an additional expenditure on upgrades and refresher courses for coders and physicians.

"After everything, poof, it’s gone in a puff of smoke because everything came to a standstill when ICD-10 got suspended for a year," said Dr. Abraham, governor of the Massachusetts chapter of the American College of Physicians. "It will be déjà vu all over again come summer of next year. We’ll be doing the same thing in preparation for ICD-10 being rolled out in October 2015."

Most health plans won’t begin end-to-end testing of claims until next year, Dr. Abraham said, and that’s worrisome because it may not provide enough time to work out potential glitches.

"A delay in claims being processed is our biggest anxiety," he said. "A delay in payments will lead to a severe cash flow crunch."

Waiting on the CMS for ICD-10 details

Few details have emerged from the Centers for Medicare & Medicaid Services since Congress delayed the implementation of the ICD-10 coding system earlier this year.

As part of Protecting Access to Medicare Act of 2014 (H.R. 4302), Congress delayed implementation of ICD-10 for at least a year. In May, CMS officials announced that the new compliance date would be Oct. 1, 2015, and that physicians and hospitals must continue to use ICD-9 through Sept. 30, 2015.

The agency said it would release an interim final rule in the "near future" with additional details about the compliance date.

Since then, the CMS canceled the end-to-end system testing that had been scheduled for July. The testing will be held sometime in 2015 instead, according to the agency.

But the CMS did report on results of acknowledgement testing conducted with Medicare fee-for-service contractors in March. During the test, providers, suppliers, billing companies, and clearinghouses sent more than 127,000 claims with ICD-10 codes to the Medicare fee-for-service claims system. They received an electronic acknowledgement if their claims were accepted. The exercise did not test whether the claims test had sufficient documentation to be paid by Medicare.

 

 

Overall, the CMS accepted 89% of the test claims, below the normal average Medicare claims acceptance rates of 95% to 98%.

Negative testing – the purposeful submission of error-filled claims to force a rejection – could be one reason for the lower acceptance rate, according to Niall Brennan, acting director of the CMS Offices of Enterprise Management.

While physicians and other providers can submit claims for acknowledgement testing anytime up to the implementation date, Mr. Brennan recommended waiting until after Oct. 6, 2014, when Medicare updates its systems.

Physicians should contact their local Medicare Administrative Contractor for information on acknowledgement testing, according to the CMS.

[email protected]

On Twitter @maryellenny

When it comes to ICD-10 readiness, invest in low-cost, high-impact steps that will benefit the October 2015 switch to new code set, but will also improve the general health of the medical practice.

Now that implementation of ICD-10 has been delayed a full year, "I’d avoid spending too much money at this stage," said Robert Tennant, senior policy advisor at the Medical Group Management Association (MGMA).

Practical steps include checking claims already paid under ICD-9 to see whether the documentation was sufficient to assign an ICD-10 code. In the case of a sprained wrist, for example, make sure the documentation includes whether the injury was to the left or right wrist, Mr. Tennant said.

Robert M. Tennant

Consider dual coding – coding the same claims in both ICD-9 and ICD-10 – for some most commonly used codes, Mr. Tennant advised. If you "go through the clinical documentation improvement exercises, you will produce a better quality medical record and that can help the practice in a number of ways even if ICD-10 never goes forward."

Other low-cost, high-impact steps include reaching out to clearinghouses to request reports on the practice’s top diagnosis codes, the top pended or rejected claims, and the most frequently used unspecified codes.

"That should really focus the practice in on those claims that are the most problematic," he said.

One tough decision is when to upgrade software. Upgrade too early and the practice could lose money if there’s another delay. Wait too long and the practice risks being unprepared for the compliance date, Mr. Tennant said.

He advised finding out when the vendor will be ready with upgrades and how long it will take them to install the software and provide training. Use that to build an implementation timeline.

"It’s such a tightrope that practices have to walk," Mr. Tennant said.

Dallas-based pediatrician Joseph Schneider has been helping physicians prepare for ICD-10 in his role as chair of the Texas Medical Association’s Practice Management Services Council. The association’s official policy is that the move to ICD-10 should be scrapped, but the group is urging physicians and hospitals to prepare anyway.

Dr. Schneider said smaller practices should check in with payers, vendors, and clearinghouses now, but save significant investments and training for next year.

"If you’re in a small physician practice, probably doing not very much between now and December might be a pretty good strategy," he said. "From January forward, you have to start your engines and get everything ready."

But larger practices and health systems don’t have the luxury of waiting, he said.

Dr. George Abraham

Dr. George Abraham, who is part of a six-physician practice in Worcester, Mass., was ready for ICD-10 to take effect this year. His practice spent more than $25,000 preparing for the scheduled switch and had done some initial testing of systems when the delay was announced.

Now the practice faces an additional expenditure on upgrades and refresher courses for coders and physicians.

"After everything, poof, it’s gone in a puff of smoke because everything came to a standstill when ICD-10 got suspended for a year," said Dr. Abraham, governor of the Massachusetts chapter of the American College of Physicians. "It will be déjà vu all over again come summer of next year. We’ll be doing the same thing in preparation for ICD-10 being rolled out in October 2015."

Most health plans won’t begin end-to-end testing of claims until next year, Dr. Abraham said, and that’s worrisome because it may not provide enough time to work out potential glitches.

"A delay in claims being processed is our biggest anxiety," he said. "A delay in payments will lead to a severe cash flow crunch."

Waiting on the CMS for ICD-10 details

Few details have emerged from the Centers for Medicare & Medicaid Services since Congress delayed the implementation of the ICD-10 coding system earlier this year.

As part of Protecting Access to Medicare Act of 2014 (H.R. 4302), Congress delayed implementation of ICD-10 for at least a year. In May, CMS officials announced that the new compliance date would be Oct. 1, 2015, and that physicians and hospitals must continue to use ICD-9 through Sept. 30, 2015.

The agency said it would release an interim final rule in the "near future" with additional details about the compliance date.

Since then, the CMS canceled the end-to-end system testing that had been scheduled for July. The testing will be held sometime in 2015 instead, according to the agency.

But the CMS did report on results of acknowledgement testing conducted with Medicare fee-for-service contractors in March. During the test, providers, suppliers, billing companies, and clearinghouses sent more than 127,000 claims with ICD-10 codes to the Medicare fee-for-service claims system. They received an electronic acknowledgement if their claims were accepted. The exercise did not test whether the claims test had sufficient documentation to be paid by Medicare.

 

 

Overall, the CMS accepted 89% of the test claims, below the normal average Medicare claims acceptance rates of 95% to 98%.

Negative testing – the purposeful submission of error-filled claims to force a rejection – could be one reason for the lower acceptance rate, according to Niall Brennan, acting director of the CMS Offices of Enterprise Management.

While physicians and other providers can submit claims for acknowledgement testing anytime up to the implementation date, Mr. Brennan recommended waiting until after Oct. 6, 2014, when Medicare updates its systems.

Physicians should contact their local Medicare Administrative Contractor for information on acknowledgement testing, according to the CMS.

[email protected]

On Twitter @maryellenny

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Naloxegol cut opioid-associated constipation without impairing pain relief

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Naloxegol cut opioid-associated constipation without impairing pain relief

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

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Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

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Key clinical point: Naloxegol improves opioid-induced constipation without affecting pain relief.

Major finding: Treatment with naloxegol was associated with a significantly shorter time to first spontaneous bowel movement, a significantly greater number of spontaneous bowel movements, and an increase in the mean number of days per week with one or more spontaneous bowel movements, compared with placebo.

Data source: Two identical 12-week, phase III, double-blind, randomized, controlled trials in a total of 1,352 patients with opioid-associated constipation.

Disclosures: AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies including AstraZeneca.

Type 2 diabetes remits in some bariatric surgery patients

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In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.

Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.

Dr. Anita P. Courcoulas

The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.

"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.

The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m2. The mean duration of type 2 diabetes was 6 years. The average HbA1c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.

By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.

Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).

Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.

The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.

Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.

"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.

The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.

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In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.

Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.

Dr. Anita P. Courcoulas

The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.

"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.

The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m2. The mean duration of type 2 diabetes was 6 years. The average HbA1c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.

By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.

Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).

Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.

The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.

Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.

"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.

The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.

[email protected]

In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.

Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.

Dr. Anita P. Courcoulas

The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.

"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.

The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m2. The mean duration of type 2 diabetes was 6 years. The average HbA1c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.

By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.

Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).

Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.

The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.

Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.

"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.

The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.

[email protected]

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Type 2 diabetes remits in some bariatric surgery patients
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obese, type 2 diabetes, Roux-en-Y, gastric bypass, laparoscopic adjustable gastric banding, Dr. Anita Courcoulas,
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obese, type 2 diabetes, Roux-en-Y, gastric bypass, laparoscopic adjustable gastric banding, Dr. Anita Courcoulas,
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FROM JAMA SURGERY

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Key clinical point: Bariatric surgery was linked to type 2 diabetes remission in some moderately obese patients.

Major finding: Complete remission occurred in 17% of Roux-en-Y bypass patients and 23% of gastric banding patients, but in none of those assigned to a lifestyle intervention.

Data source: The three-way randomized trial of 69 patients.

Disclosures: The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.

Nearly 30 million uninsured Americans to gain health coverage by 2016

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Nearly 30 million uninsured Americans to gain health coverage by 2016

Fifty-six percent of uninsured patients in the United States are now eligible for financial assistance with insurance coverage through Medicaid, the Children\'s Health Insurance Program, or subsidized private coverage under the Affordable Care Act, according to a report from the Robert Wood Johnson Foundation and the Urban Institute.

The analysis estimates the ACA ultimately will lead to more than 27 million previously uninsured patients gaining health insurance coverage by 2016.

In states that have expanded Medicaid eligibility under the ACA, 68% of the uninsured have become eligible for assistance, compared with 44% of newly eligible patients in states that have not expanded Medicaid.

Significant state variation remains in the number of uninsured newly eligible for financial assistance. West Virginia tops the list with a high of 83% of the formerly uninsured now covered, while Texas has the lowest number of newly insured at 40%.

"Financial assistance is a big factor in whether or not an individual obtains health insurance under the Affordable Care Act," said Katherine Hempstead, Robert Wood Johnson Foundation team director and senior program officer. "Early data suggest that the [uninsured] rate in states that expanded Medicaid has dropped more sharply than in states that decided against the expansion."

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Fifty-six percent of uninsured patients in the United States are now eligible for financial assistance with insurance coverage through Medicaid, the Children\'s Health Insurance Program, or subsidized private coverage under the Affordable Care Act, according to a report from the Robert Wood Johnson Foundation and the Urban Institute.

The analysis estimates the ACA ultimately will lead to more than 27 million previously uninsured patients gaining health insurance coverage by 2016.

In states that have expanded Medicaid eligibility under the ACA, 68% of the uninsured have become eligible for assistance, compared with 44% of newly eligible patients in states that have not expanded Medicaid.

Significant state variation remains in the number of uninsured newly eligible for financial assistance. West Virginia tops the list with a high of 83% of the formerly uninsured now covered, while Texas has the lowest number of newly insured at 40%.

"Financial assistance is a big factor in whether or not an individual obtains health insurance under the Affordable Care Act," said Katherine Hempstead, Robert Wood Johnson Foundation team director and senior program officer. "Early data suggest that the [uninsured] rate in states that expanded Medicaid has dropped more sharply than in states that decided against the expansion."

Fifty-six percent of uninsured patients in the United States are now eligible for financial assistance with insurance coverage through Medicaid, the Children\'s Health Insurance Program, or subsidized private coverage under the Affordable Care Act, according to a report from the Robert Wood Johnson Foundation and the Urban Institute.

The analysis estimates the ACA ultimately will lead to more than 27 million previously uninsured patients gaining health insurance coverage by 2016.

In states that have expanded Medicaid eligibility under the ACA, 68% of the uninsured have become eligible for assistance, compared with 44% of newly eligible patients in states that have not expanded Medicaid.

Significant state variation remains in the number of uninsured newly eligible for financial assistance. West Virginia tops the list with a high of 83% of the formerly uninsured now covered, while Texas has the lowest number of newly insured at 40%.

"Financial assistance is a big factor in whether or not an individual obtains health insurance under the Affordable Care Act," said Katherine Hempstead, Robert Wood Johnson Foundation team director and senior program officer. "Early data suggest that the [uninsured] rate in states that expanded Medicaid has dropped more sharply than in states that decided against the expansion."

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