ACS Surgery News

Laparoscopic resection of rectal cancer is noninferior to open surgery in preventing locoregional recurrence and in improving overall and disease-free survival, according to a report published online April 1 in the New England Journal of Medicine.

The laparoscopic approach has increasingly replaced open surgery in recent years, primarily because it offers short-term advantages such as less pain, reduced blood loss, and a shorter recovery time. But no large randomized trials have established that long-term outcomes with laparoscopic resection, including survival, are at least noninferior to those with open surgery, said Dr. Hendrik Jaap Bonjer of VU University Medical Center, Amsterdam, and his associates.

They now report the 3-year outcomes of the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial, an industry-sponsored noninferiority study performed at 30 medical centers in eight countries in Europe, North America, and Asia. The trial involved 1,044 patients who had solitary, noninvasive adenocarcinomas of the rectum within 15 cm of the anal verge. A total of 699 of the study participants were randomly assigned to laparoscopic and 345 to open surgery.

At 3-year follow-up, the rate of locoregional recurrence was identical between the two study groups, at 5% each. In addition, rates of disease-free survival slightly favored the laparoscopic approach (74.8%) over the open approach (70.8%), as did rates of overall survival (86.7% and 83.6%, respectively) and rates of distant metastases (19.1% and 22.1%, respectively). Patients with stage III disease appeared to benefit the most from laparoscopic surgery, with disease-free survival of 64.9% vs. 52.0%, the investigators said (N. Engl. J. Med. 2015 April 1 [doi:10.1056/NEJMoa1414882]). These findings support the idea that the reduced surgical trauma associated with laparoscopic techniques may decrease tumor recurrence, perhaps by attenuating stress responses and preserving immune function, they noted.

“In our study, laparoscopic surgery in patients with cancer in the lower third of the rectum was associated with a lower rate of involved circumferential resection margin and a lower locoregional recurrence rate than was open surgery. During laparoscopic surgery, narrow spaces such as the lower pelvis are better visualized than in open surgery, owing to the use of a laparoscope, which projects a magnified and well-illuminated image of the operative field on the monitors. A clear view is of paramount importance to accomplish a resection of the cancer with sufficient margins,” Dr. Bonjer and his associates added.

The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.

Laparoscopic resection of rectal cancer is noninferior to open surgery in preventing locoregional recurrence and in improving overall and disease-free survival, according to a report published online April 1 in the New England Journal of Medicine.

The laparoscopic approach has increasingly replaced open surgery in recent years, primarily because it offers short-term advantages such as less pain, reduced blood loss, and a shorter recovery time. But no large randomized trials have established that long-term outcomes with laparoscopic resection, including survival, are at least noninferior to those with open surgery, said Dr. Hendrik Jaap Bonjer of VU University Medical Center, Amsterdam, and his associates.

They now report the 3-year outcomes of the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial, an industry-sponsored noninferiority study performed at 30 medical centers in eight countries in Europe, North America, and Asia. The trial involved 1,044 patients who had solitary, noninvasive adenocarcinomas of the rectum within 15 cm of the anal verge. A total of 699 of the study participants were randomly assigned to laparoscopic and 345 to open surgery.

At 3-year follow-up, the rate of locoregional recurrence was identical between the two study groups, at 5% each. In addition, rates of disease-free survival slightly favored the laparoscopic approach (74.8%) over the open approach (70.8%), as did rates of overall survival (86.7% and 83.6%, respectively) and rates of distant metastases (19.1% and 22.1%, respectively). Patients with stage III disease appeared to benefit the most from laparoscopic surgery, with disease-free survival of 64.9% vs. 52.0%, the investigators said (N. Engl. J. Med. 2015 April 1 [doi:10.1056/NEJMoa1414882]). These findings support the idea that the reduced surgical trauma associated with laparoscopic techniques may decrease tumor recurrence, perhaps by attenuating stress responses and preserving immune function, they noted.

“In our study, laparoscopic surgery in patients with cancer in the lower third of the rectum was associated with a lower rate of involved circumferential resection margin and a lower locoregional recurrence rate than was open surgery. During laparoscopic surgery, narrow spaces such as the lower pelvis are better visualized than in open surgery, owing to the use of a laparoscope, which projects a magnified and well-illuminated image of the operative field on the monitors. A clear view is of paramount importance to accomplish a resection of the cancer with sufficient margins,” Dr. Bonjer and his associates added.

The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.

Laparoscopic resection of rectal cancer is noninferior to open surgery in preventing locoregional recurrence and in improving overall and disease-free survival, according to a report published online April 1 in the New England Journal of Medicine.

The laparoscopic approach has increasingly replaced open surgery in recent years, primarily because it offers short-term advantages such as less pain, reduced blood loss, and a shorter recovery time. But no large randomized trials have established that long-term outcomes with laparoscopic resection, including survival, are at least noninferior to those with open surgery, said Dr. Hendrik Jaap Bonjer of VU University Medical Center, Amsterdam, and his associates.

They now report the 3-year outcomes of the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial, an industry-sponsored noninferiority study performed at 30 medical centers in eight countries in Europe, North America, and Asia. The trial involved 1,044 patients who had solitary, noninvasive adenocarcinomas of the rectum within 15 cm of the anal verge. A total of 699 of the study participants were randomly assigned to laparoscopic and 345 to open surgery.

At 3-year follow-up, the rate of locoregional recurrence was identical between the two study groups, at 5% each. In addition, rates of disease-free survival slightly favored the laparoscopic approach (74.8%) over the open approach (70.8%), as did rates of overall survival (86.7% and 83.6%, respectively) and rates of distant metastases (19.1% and 22.1%, respectively). Patients with stage III disease appeared to benefit the most from laparoscopic surgery, with disease-free survival of 64.9% vs. 52.0%, the investigators said (N. Engl. J. Med. 2015 April 1 [doi:10.1056/NEJMoa1414882]). These findings support the idea that the reduced surgical trauma associated with laparoscopic techniques may decrease tumor recurrence, perhaps by attenuating stress responses and preserving immune function, they noted.

“In our study, laparoscopic surgery in patients with cancer in the lower third of the rectum was associated with a lower rate of involved circumferential resection margin and a lower locoregional recurrence rate than was open surgery. During laparoscopic surgery, narrow spaces such as the lower pelvis are better visualized than in open surgery, owing to the use of a laparoscope, which projects a magnified and well-illuminated image of the operative field on the monitors. A clear view is of paramount importance to accomplish a resection of the cancer with sufficient margins,” Dr. Bonjer and his associates added.

The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.

Women with Crohn’s disease had about a 53% greater risk of developing cervical cancer compared with controls, and women with inflammatory bowel disease had a significantly greater risk of having had cervical neoplasia years earlier, according to a large population-based study reported in the April issue of Clinical Gastroenterology and Hepatology (http://dx.doi.org/10.1016/j.cgh.2014.07.036).

“We found a two-way association between inflammatory bowel disease, notably Crohn’s disease, and neoplastic lesions of the uterine cervix. This observation is not explained by differences in screening activity,” said Dr. Christine Rungoe at Statens Serum Institut in Copenhagen and her associates. “Patients with IBD should be encouraged to follow the screening program for cervical neoplasia, and clinicians should be aware of the slightly increased risk of HPV-related cervical lesions in IBD patients.”

Studies of IBD and cervical neoplasia have yielded mixed results as to a possible association. Some experts have postulated that underlying immunologic changes or the use of immunosuppressive drugs in IBD could thwart patients’ ability to clear HPV infections, thereby increasing their risk of developing cervical neoplasia. To explore that possibility, Dr. Rungoe and her associates compared rates of cervical dysplasia or cervical cancer among 27,408 women newly diagnosed with ulcerative colitis or Crohn’s disease and 1,508,334 controls without IBD. They identified cases and controls from a national patient registry of about 4 million women living in Denmark during 1979-2011. They also calculated the likelihood of a cervical neoplasia diagnosis preceding IBD.

Women with Crohn’s disease had a 26% higher rate of low-grade intraepithelial lesions of the cervix, a 28% greater incidence of high-grade lesions, and a 53% greater risk of cervical cancer compared with controls, the researchers reported (incidence rate ratios and 95% confidence intervals, respectively: 1.26, 1.07-1.48; 1.28, 1.13-1.45; and 1.53, 1.04-2.27). Women with ulcerative colitis also had about a 12%-15% increase in risk of developing cervical dysplasia, compared with controls (IRR for low-grade lesions, 1.15; 95% CI, 1.00-1.32; IRR for high-grade lesions, 1.12; 95% CI, 1.01-1.25), but no significant increase in cervical cancer risk.

Notably, women newly diagnosed with IBD had a “markedly elevated” odds of having been diagnosed with cervical neoplasia up to 10 years beforehand, the investigators reported. “This is a novel finding that may suggest a yet unexplored common susceptibility to IBD and cervical neoplasia, rather than an etiologic role of IBD or its treatment in development of cervical neoplasia,” they said.

Treatment with common IBD therapies such as azathioprine, mesalamine, and corticosteroids did not affect rates of cervical neoplasia, but women with Crohn’s disease who had used tumor necrosis factor–alpha antagonists had an 85% increase in high-grade intraepithelial cervical lesions. They also had a 2% increase in risk of these lesions for each filled prescription for hormonal contraceptives.

The frequency of cervical screening was slightly higher among women with ulcerative colitis, compared with controls, but was similar between controls and women with Crohn’s disease, the investigators noted.

The study was funded in part by the Danish Council of Independent Research. The investigators reported having no relevant financial disclosures.

Women with Crohn’s disease had about a 53% greater risk of developing cervical cancer compared with controls, and women with inflammatory bowel disease had a significantly greater risk of having had cervical neoplasia years earlier, according to a large population-based study reported in the April issue of Clinical Gastroenterology and Hepatology (http://dx.doi.org/10.1016/j.cgh.2014.07.036).

“We found a two-way association between inflammatory bowel disease, notably Crohn’s disease, and neoplastic lesions of the uterine cervix. This observation is not explained by differences in screening activity,” said Dr. Christine Rungoe at Statens Serum Institut in Copenhagen and her associates. “Patients with IBD should be encouraged to follow the screening program for cervical neoplasia, and clinicians should be aware of the slightly increased risk of HPV-related cervical lesions in IBD patients.”

Studies of IBD and cervical neoplasia have yielded mixed results as to a possible association. Some experts have postulated that underlying immunologic changes or the use of immunosuppressive drugs in IBD could thwart patients’ ability to clear HPV infections, thereby increasing their risk of developing cervical neoplasia. To explore that possibility, Dr. Rungoe and her associates compared rates of cervical dysplasia or cervical cancer among 27,408 women newly diagnosed with ulcerative colitis or Crohn’s disease and 1,508,334 controls without IBD. They identified cases and controls from a national patient registry of about 4 million women living in Denmark during 1979-2011. They also calculated the likelihood of a cervical neoplasia diagnosis preceding IBD.

Women with Crohn’s disease had a 26% higher rate of low-grade intraepithelial lesions of the cervix, a 28% greater incidence of high-grade lesions, and a 53% greater risk of cervical cancer compared with controls, the researchers reported (incidence rate ratios and 95% confidence intervals, respectively: 1.26, 1.07-1.48; 1.28, 1.13-1.45; and 1.53, 1.04-2.27). Women with ulcerative colitis also had about a 12%-15% increase in risk of developing cervical dysplasia, compared with controls (IRR for low-grade lesions, 1.15; 95% CI, 1.00-1.32; IRR for high-grade lesions, 1.12; 95% CI, 1.01-1.25), but no significant increase in cervical cancer risk.

Notably, women newly diagnosed with IBD had a “markedly elevated” odds of having been diagnosed with cervical neoplasia up to 10 years beforehand, the investigators reported. “This is a novel finding that may suggest a yet unexplored common susceptibility to IBD and cervical neoplasia, rather than an etiologic role of IBD or its treatment in development of cervical neoplasia,” they said.

Treatment with common IBD therapies such as azathioprine, mesalamine, and corticosteroids did not affect rates of cervical neoplasia, but women with Crohn’s disease who had used tumor necrosis factor–alpha antagonists had an 85% increase in high-grade intraepithelial cervical lesions. They also had a 2% increase in risk of these lesions for each filled prescription for hormonal contraceptives.

The frequency of cervical screening was slightly higher among women with ulcerative colitis, compared with controls, but was similar between controls and women with Crohn’s disease, the investigators noted.

The study was funded in part by the Danish Council of Independent Research. The investigators reported having no relevant financial disclosures.

Women with Crohn’s disease had about a 53% greater risk of developing cervical cancer compared with controls, and women with inflammatory bowel disease had a significantly greater risk of having had cervical neoplasia years earlier, according to a large population-based study reported in the April issue of Clinical Gastroenterology and Hepatology (http://dx.doi.org/10.1016/j.cgh.2014.07.036).

“We found a two-way association between inflammatory bowel disease, notably Crohn’s disease, and neoplastic lesions of the uterine cervix. This observation is not explained by differences in screening activity,” said Dr. Christine Rungoe at Statens Serum Institut in Copenhagen and her associates. “Patients with IBD should be encouraged to follow the screening program for cervical neoplasia, and clinicians should be aware of the slightly increased risk of HPV-related cervical lesions in IBD patients.”

Studies of IBD and cervical neoplasia have yielded mixed results as to a possible association. Some experts have postulated that underlying immunologic changes or the use of immunosuppressive drugs in IBD could thwart patients’ ability to clear HPV infections, thereby increasing their risk of developing cervical neoplasia. To explore that possibility, Dr. Rungoe and her associates compared rates of cervical dysplasia or cervical cancer among 27,408 women newly diagnosed with ulcerative colitis or Crohn’s disease and 1,508,334 controls without IBD. They identified cases and controls from a national patient registry of about 4 million women living in Denmark during 1979-2011. They also calculated the likelihood of a cervical neoplasia diagnosis preceding IBD.

Women with Crohn’s disease had a 26% higher rate of low-grade intraepithelial lesions of the cervix, a 28% greater incidence of high-grade lesions, and a 53% greater risk of cervical cancer compared with controls, the researchers reported (incidence rate ratios and 95% confidence intervals, respectively: 1.26, 1.07-1.48; 1.28, 1.13-1.45; and 1.53, 1.04-2.27). Women with ulcerative colitis also had about a 12%-15% increase in risk of developing cervical dysplasia, compared with controls (IRR for low-grade lesions, 1.15; 95% CI, 1.00-1.32; IRR for high-grade lesions, 1.12; 95% CI, 1.01-1.25), but no significant increase in cervical cancer risk.

Notably, women newly diagnosed with IBD had a “markedly elevated” odds of having been diagnosed with cervical neoplasia up to 10 years beforehand, the investigators reported. “This is a novel finding that may suggest a yet unexplored common susceptibility to IBD and cervical neoplasia, rather than an etiologic role of IBD or its treatment in development of cervical neoplasia,” they said.

Treatment with common IBD therapies such as azathioprine, mesalamine, and corticosteroids did not affect rates of cervical neoplasia, but women with Crohn’s disease who had used tumor necrosis factor–alpha antagonists had an 85% increase in high-grade intraepithelial cervical lesions. They also had a 2% increase in risk of these lesions for each filled prescription for hormonal contraceptives.

The frequency of cervical screening was slightly higher among women with ulcerative colitis, compared with controls, but was similar between controls and women with Crohn’s disease, the investigators noted.

The study was funded in part by the Danish Council of Independent Research. The investigators reported having no relevant financial disclosures.

Physicians cannot sue state governments over low Medicaid payments, the U.S. Supreme Court ruled.

In a 5-4 decision, the high court overturned a decision by the 9th Circuit Court of Appeals that said physicians and other providers could sue to hold states accountable to the equal access provisions of the Medicaid Act (states accepting federal Medicaid funding are required to set pay rates at levels sufficient to ensure access to care).

©trekandshoot/thinkstockphotos.com

In the case, Armstrong v. Exceptional Child Centers Inc., justices were determining whether the Constitution’s Supremacy Clause – which establishes the Constitution and federal law as the law of the land – gives providers the right to sue. The case originates from a 2009 lawsuit by Exceptional Child Center Inc., of Twin Falls, Idaho, and four other residential habilitation centers against Richard Armstrong, director of the Idaho Department of Health and Welfare.

In the majority opinion, Justice Antonin Scalia noted that physicians who believe Medicaid rates are inadequate have an administrative remedy by petitioning the Centers for Medicare & Medicaid Services, a remedy that “shows that the Medicaid Act precludes private enforcement ... in the courts.” He added that the plaintiffs must first seek relief through CMS first before instigating legal action.

In the dissenting opinion, Justice Sonia Sotomayor noted that seeking administrative relief could lead to reduced federal funding to a state for violating the Medicaid Act’s rate requirements, adding that “HHS is often reluctant to initiate compliance actions because a ‘state’s noncompliance creates a damned-if-you-do, damned-if-you-don’t scenario where withholding of state funds will lead to depriving the poor of essential medical assistance.’ ”

Justice Scalia dismissed that logic. “The dissent’s complaint that the sanction available to the [HHS] Secretary (the cut-off of funding) is too massive to be a realistic source of relief seems to us mistaken. We doubt that the Secretary’s notice to a state that its compensation scheme is inadequate will be ignored.”

[email protected]

Physicians cannot sue state governments over low Medicaid payments, the U.S. Supreme Court ruled.

In a 5-4 decision, the high court overturned a decision by the 9th Circuit Court of Appeals that said physicians and other providers could sue to hold states accountable to the equal access provisions of the Medicaid Act (states accepting federal Medicaid funding are required to set pay rates at levels sufficient to ensure access to care).

©trekandshoot/thinkstockphotos.com

In the case, Armstrong v. Exceptional Child Centers Inc., justices were determining whether the Constitution’s Supremacy Clause – which establishes the Constitution and federal law as the law of the land – gives providers the right to sue. The case originates from a 2009 lawsuit by Exceptional Child Center Inc., of Twin Falls, Idaho, and four other residential habilitation centers against Richard Armstrong, director of the Idaho Department of Health and Welfare.

In the majority opinion, Justice Antonin Scalia noted that physicians who believe Medicaid rates are inadequate have an administrative remedy by petitioning the Centers for Medicare & Medicaid Services, a remedy that “shows that the Medicaid Act precludes private enforcement ... in the courts.” He added that the plaintiffs must first seek relief through CMS first before instigating legal action.

In the dissenting opinion, Justice Sonia Sotomayor noted that seeking administrative relief could lead to reduced federal funding to a state for violating the Medicaid Act’s rate requirements, adding that “HHS is often reluctant to initiate compliance actions because a ‘state’s noncompliance creates a damned-if-you-do, damned-if-you-don’t scenario where withholding of state funds will lead to depriving the poor of essential medical assistance.’ ”

Justice Scalia dismissed that logic. “The dissent’s complaint that the sanction available to the [HHS] Secretary (the cut-off of funding) is too massive to be a realistic source of relief seems to us mistaken. We doubt that the Secretary’s notice to a state that its compensation scheme is inadequate will be ignored.”

[email protected]

Physicians cannot sue state governments over low Medicaid payments, the U.S. Supreme Court ruled.

In a 5-4 decision, the high court overturned a decision by the 9th Circuit Court of Appeals that said physicians and other providers could sue to hold states accountable to the equal access provisions of the Medicaid Act (states accepting federal Medicaid funding are required to set pay rates at levels sufficient to ensure access to care).

©trekandshoot/thinkstockphotos.com

In the case, Armstrong v. Exceptional Child Centers Inc., justices were determining whether the Constitution’s Supremacy Clause – which establishes the Constitution and federal law as the law of the land – gives providers the right to sue. The case originates from a 2009 lawsuit by Exceptional Child Center Inc., of Twin Falls, Idaho, and four other residential habilitation centers against Richard Armstrong, director of the Idaho Department of Health and Welfare.

In the majority opinion, Justice Antonin Scalia noted that physicians who believe Medicaid rates are inadequate have an administrative remedy by petitioning the Centers for Medicare & Medicaid Services, a remedy that “shows that the Medicaid Act precludes private enforcement ... in the courts.” He added that the plaintiffs must first seek relief through CMS first before instigating legal action.

In the dissenting opinion, Justice Sonia Sotomayor noted that seeking administrative relief could lead to reduced federal funding to a state for violating the Medicaid Act’s rate requirements, adding that “HHS is often reluctant to initiate compliance actions because a ‘state’s noncompliance creates a damned-if-you-do, damned-if-you-don’t scenario where withholding of state funds will lead to depriving the poor of essential medical assistance.’ ”

Justice Scalia dismissed that logic. “The dissent’s complaint that the sanction available to the [HHS] Secretary (the cut-off of funding) is too massive to be a realistic source of relief seems to us mistaken. We doubt that the Secretary’s notice to a state that its compensation scheme is inadequate will be ignored.”

[email protected]

BIRMINGHAM, ALA. – The perception that one’s physician had recommended contralateral prophylactic mastectomy was a particularly important factor in the decision to undergo the procedure among BRCA1/2 mutation noncarriers with newly diagnosed breast cancer in a prospective study.

Of 90 BRCA noncarriers with newly diagnosed breast cancer, a “sizable minority” (24.4%) chose to undergo contralateral prophylactic mastectomy (CPM) after learning their mutation status, Jada G. Hamilton, Ph.D., reported at the annual meeting of the American Society of Preventive Oncology.

By comparison, 88% of eight BRCA1/2 carriers who participated in the study chose to undergo CPM, and neither of two women with a BRCA1/2 variant of undetermined significance chose to undergo CPM.

On multivariate analysis, the perception that one’s physician had recommended CPM was most strongly associated with the decision to undergo the procedure (odds ratio, 11.1), said Dr. Hamilton of Memorial Sloan-Kettering Cancer Center, New York.

Other factors associated with the decision were a perception of greater risk for contralateral breast cancer (OR, 6.46) and a perception of greater pros of CPM (OR, 1.37), she said, noting that those who indicated they would feel good about having CPM and those who indicated they might feel regret if they didn’t have CPM were most likely to elect CPM.

Age, Ashkenazi Jewish ethnicity, breast cancer–related distress, perceived cons of CPM (such as disfigurement and concerns regarding a negative impact on one’s sex life), and decisional conflict regarding CPM were not significantly associated with the decision.

Presurgical genetic testing provides valuable information to women with newly diagnosed breast cancer as they begin to make decisions about treatment, Dr. Hamilton said. Although BRCA1/2 mutation noncarriers have a low (3%-10%) risk, compared with carriers (27%-37%), studies suggest that about 18% nevertheless choose to undergo CPM.

The psychosocial factors that may affect the decision are not well understood, Dr. Hamilton said.

For the current analysis, participants who were part of a larger prospective study on presurgical BRCA1/2 testing completed a questionnaire, and the frequency and psychosocial correlates of the decision to undergo a CPM were assessed. The participants were adult women with a median age of 43 years (range of 29-59 years).

The findings raise interesting questions for future work, Dr. Hamilton said.

“I think it’s really critical for future studies to dig in to what’s happening in terms of physician-patient communication around CPM,” she said, noting that it will be important to explore how such communication interacts with a woman’s past experiences, emotions, and beliefs to shape her cancer prevention decisions.

Further, the women who undergo CPM should be followed to assess their long-term outcomes with respect to factors such as quality of life, satisfaction, and decisional regret, she concluded.

The decision to undergo CPM and the effects of physician-patient communication on that decision were also addressed in another study presented at the meeting.

In that study – a mixed methods pilot study looking mainly at factors affecting informed decision making in women who had ductal carcinoma in situ (DCIS) or who were considered to be at increased risk of invasive breast cancer risk because of a diagnosis of lobular carcinoma in situ (LCIS), BRCA positivity, or 20% or greater calculated lifetime risk – anxiety about cancer recurrence was the top reason for pursuing CPM.

Despite a lack of survival benefit, an increasing number of women with DCIS are undergoing CPM, but little is known about the decision-making process, said Jessica Valente of Emory University, Atlanta.

She and her colleagues sought to identify factors impacting risk comprehension and decision making. Of 68 women with DCIS or who were at high risk for development of invasive breast cancer, 33 considered CPM and 11 underwent the procedure.

The choice to undergo CPM was significantly associated with plastic surgery consultation, increased 10-year breast cancer risk, genetic counseling, genetic testing, and higher income, she said.

The study also highlighted a lack of health literacy and understanding of related terminology.

Most participants (nearly 84%) stated that DCIS qualified as breast cancer, but only about 40% correctly defined DCIS, Ms. Valente said.

When asked what they would recommend as a treatment strategy for a friend with DCIS, 35% thought surgery would be best. A similar percentage would recommend surgery for LCIS.

“When we looked at ductal hyperplasia, fewer people thought that that qualified as cancer, and they were more likely to recommend observation,” she said.

Further, when asked to interpret the phrase “indolent lesion of epithelial origin,” which is a phrase that has been promoted as a replacement for “DCIS” in light of concerns that women are increasingly electing CPM for DCIS because of fear of the word “carcinoma” despite a 99% survival rate, only 28% of patients believed it referred to cancer.

Observation was one of the highly recommended interventions for “indolent lesion of epithelial origin,” followed by biopsy, she said, noting that only 13% recommended surgery when this phrase was used.

“Interestingly, 7.4% said an oral or topical medication [should be used for “indolent lesion of epithelial origin]” – a finding likely explained by the fact that some women interpreted the word “lesion” to mean a wound or sore on the skin, she said.

Additionally, few women were able to define contralateral prophylactic mastectomy.

Overall, despite the study population being very well educated and from a higher socioeconomic status, they had low scores for understanding terminology (8.21 out of 20), Ms. Valente noted.

The findings demonstrate that decision making in the context of DCIS remains complex and underscore the importance of recognizing patients’ knowledge of risk communication and terminology for supporting shared and informed surgical decision making, she said.

The findings also demonstrate that while fewer women felt that surgery was appropriate when the term “indolent lesion of epithelial origin” was used instead of “DCIS,” the proposed new terminology doesn’t necessarily provide the desired clarity, she noted.

“They still came up with such a broad range of interpretations that we really might be introducing a new set of conflicts and confusion when we think about changing to that terminology when we talk to patients,” she concluded.

Dr. Hamilton and Ms. Valente each reported having no disclosures.

BIRMINGHAM, ALA. – The perception that one’s physician had recommended contralateral prophylactic mastectomy was a particularly important factor in the decision to undergo the procedure among BRCA1/2 mutation noncarriers with newly diagnosed breast cancer in a prospective study.

Of 90 BRCA noncarriers with newly diagnosed breast cancer, a “sizable minority” (24.4%) chose to undergo contralateral prophylactic mastectomy (CPM) after learning their mutation status, Jada G. Hamilton, Ph.D., reported at the annual meeting of the American Society of Preventive Oncology.

By comparison, 88% of eight BRCA1/2 carriers who participated in the study chose to undergo CPM, and neither of two women with a BRCA1/2 variant of undetermined significance chose to undergo CPM.

On multivariate analysis, the perception that one’s physician had recommended CPM was most strongly associated with the decision to undergo the procedure (odds ratio, 11.1), said Dr. Hamilton of Memorial Sloan-Kettering Cancer Center, New York.

Other factors associated with the decision were a perception of greater risk for contralateral breast cancer (OR, 6.46) and a perception of greater pros of CPM (OR, 1.37), she said, noting that those who indicated they would feel good about having CPM and those who indicated they might feel regret if they didn’t have CPM were most likely to elect CPM.

Age, Ashkenazi Jewish ethnicity, breast cancer–related distress, perceived cons of CPM (such as disfigurement and concerns regarding a negative impact on one’s sex life), and decisional conflict regarding CPM were not significantly associated with the decision.

Presurgical genetic testing provides valuable information to women with newly diagnosed breast cancer as they begin to make decisions about treatment, Dr. Hamilton said. Although BRCA1/2 mutation noncarriers have a low (3%-10%) risk, compared with carriers (27%-37%), studies suggest that about 18% nevertheless choose to undergo CPM.

The psychosocial factors that may affect the decision are not well understood, Dr. Hamilton said.

For the current analysis, participants who were part of a larger prospective study on presurgical BRCA1/2 testing completed a questionnaire, and the frequency and psychosocial correlates of the decision to undergo a CPM were assessed. The participants were adult women with a median age of 43 years (range of 29-59 years).

The findings raise interesting questions for future work, Dr. Hamilton said.

“I think it’s really critical for future studies to dig in to what’s happening in terms of physician-patient communication around CPM,” she said, noting that it will be important to explore how such communication interacts with a woman’s past experiences, emotions, and beliefs to shape her cancer prevention decisions.

Further, the women who undergo CPM should be followed to assess their long-term outcomes with respect to factors such as quality of life, satisfaction, and decisional regret, she concluded.

The decision to undergo CPM and the effects of physician-patient communication on that decision were also addressed in another study presented at the meeting.

In that study – a mixed methods pilot study looking mainly at factors affecting informed decision making in women who had ductal carcinoma in situ (DCIS) or who were considered to be at increased risk of invasive breast cancer risk because of a diagnosis of lobular carcinoma in situ (LCIS), BRCA positivity, or 20% or greater calculated lifetime risk – anxiety about cancer recurrence was the top reason for pursuing CPM.

Despite a lack of survival benefit, an increasing number of women with DCIS are undergoing CPM, but little is known about the decision-making process, said Jessica Valente of Emory University, Atlanta.

She and her colleagues sought to identify factors impacting risk comprehension and decision making. Of 68 women with DCIS or who were at high risk for development of invasive breast cancer, 33 considered CPM and 11 underwent the procedure.

The choice to undergo CPM was significantly associated with plastic surgery consultation, increased 10-year breast cancer risk, genetic counseling, genetic testing, and higher income, she said.

The study also highlighted a lack of health literacy and understanding of related terminology.

Most participants (nearly 84%) stated that DCIS qualified as breast cancer, but only about 40% correctly defined DCIS, Ms. Valente said.

When asked what they would recommend as a treatment strategy for a friend with DCIS, 35% thought surgery would be best. A similar percentage would recommend surgery for LCIS.

“When we looked at ductal hyperplasia, fewer people thought that that qualified as cancer, and they were more likely to recommend observation,” she said.

Further, when asked to interpret the phrase “indolent lesion of epithelial origin,” which is a phrase that has been promoted as a replacement for “DCIS” in light of concerns that women are increasingly electing CPM for DCIS because of fear of the word “carcinoma” despite a 99% survival rate, only 28% of patients believed it referred to cancer.

Observation was one of the highly recommended interventions for “indolent lesion of epithelial origin,” followed by biopsy, she said, noting that only 13% recommended surgery when this phrase was used.

“Interestingly, 7.4% said an oral or topical medication [should be used for “indolent lesion of epithelial origin]” – a finding likely explained by the fact that some women interpreted the word “lesion” to mean a wound or sore on the skin, she said.

Additionally, few women were able to define contralateral prophylactic mastectomy.

Overall, despite the study population being very well educated and from a higher socioeconomic status, they had low scores for understanding terminology (8.21 out of 20), Ms. Valente noted.

The findings demonstrate that decision making in the context of DCIS remains complex and underscore the importance of recognizing patients’ knowledge of risk communication and terminology for supporting shared and informed surgical decision making, she said.

The findings also demonstrate that while fewer women felt that surgery was appropriate when the term “indolent lesion of epithelial origin” was used instead of “DCIS,” the proposed new terminology doesn’t necessarily provide the desired clarity, she noted.

“They still came up with such a broad range of interpretations that we really might be introducing a new set of conflicts and confusion when we think about changing to that terminology when we talk to patients,” she concluded.

Dr. Hamilton and Ms. Valente each reported having no disclosures.

BIRMINGHAM, ALA. – The perception that one’s physician had recommended contralateral prophylactic mastectomy was a particularly important factor in the decision to undergo the procedure among BRCA1/2 mutation noncarriers with newly diagnosed breast cancer in a prospective study.

Of 90 BRCA noncarriers with newly diagnosed breast cancer, a “sizable minority” (24.4%) chose to undergo contralateral prophylactic mastectomy (CPM) after learning their mutation status, Jada G. Hamilton, Ph.D., reported at the annual meeting of the American Society of Preventive Oncology.

By comparison, 88% of eight BRCA1/2 carriers who participated in the study chose to undergo CPM, and neither of two women with a BRCA1/2 variant of undetermined significance chose to undergo CPM.

On multivariate analysis, the perception that one’s physician had recommended CPM was most strongly associated with the decision to undergo the procedure (odds ratio, 11.1), said Dr. Hamilton of Memorial Sloan-Kettering Cancer Center, New York.

Other factors associated with the decision were a perception of greater risk for contralateral breast cancer (OR, 6.46) and a perception of greater pros of CPM (OR, 1.37), she said, noting that those who indicated they would feel good about having CPM and those who indicated they might feel regret if they didn’t have CPM were most likely to elect CPM.

Age, Ashkenazi Jewish ethnicity, breast cancer–related distress, perceived cons of CPM (such as disfigurement and concerns regarding a negative impact on one’s sex life), and decisional conflict regarding CPM were not significantly associated with the decision.

Presurgical genetic testing provides valuable information to women with newly diagnosed breast cancer as they begin to make decisions about treatment, Dr. Hamilton said. Although BRCA1/2 mutation noncarriers have a low (3%-10%) risk, compared with carriers (27%-37%), studies suggest that about 18% nevertheless choose to undergo CPM.

The psychosocial factors that may affect the decision are not well understood, Dr. Hamilton said.

For the current analysis, participants who were part of a larger prospective study on presurgical BRCA1/2 testing completed a questionnaire, and the frequency and psychosocial correlates of the decision to undergo a CPM were assessed. The participants were adult women with a median age of 43 years (range of 29-59 years).

The findings raise interesting questions for future work, Dr. Hamilton said.

“I think it’s really critical for future studies to dig in to what’s happening in terms of physician-patient communication around CPM,” she said, noting that it will be important to explore how such communication interacts with a woman’s past experiences, emotions, and beliefs to shape her cancer prevention decisions.

Further, the women who undergo CPM should be followed to assess their long-term outcomes with respect to factors such as quality of life, satisfaction, and decisional regret, she concluded.

The decision to undergo CPM and the effects of physician-patient communication on that decision were also addressed in another study presented at the meeting.

In that study – a mixed methods pilot study looking mainly at factors affecting informed decision making in women who had ductal carcinoma in situ (DCIS) or who were considered to be at increased risk of invasive breast cancer risk because of a diagnosis of lobular carcinoma in situ (LCIS), BRCA positivity, or 20% or greater calculated lifetime risk – anxiety about cancer recurrence was the top reason for pursuing CPM.

Despite a lack of survival benefit, an increasing number of women with DCIS are undergoing CPM, but little is known about the decision-making process, said Jessica Valente of Emory University, Atlanta.

She and her colleagues sought to identify factors impacting risk comprehension and decision making. Of 68 women with DCIS or who were at high risk for development of invasive breast cancer, 33 considered CPM and 11 underwent the procedure.

The choice to undergo CPM was significantly associated with plastic surgery consultation, increased 10-year breast cancer risk, genetic counseling, genetic testing, and higher income, she said.

The study also highlighted a lack of health literacy and understanding of related terminology.

Most participants (nearly 84%) stated that DCIS qualified as breast cancer, but only about 40% correctly defined DCIS, Ms. Valente said.

When asked what they would recommend as a treatment strategy for a friend with DCIS, 35% thought surgery would be best. A similar percentage would recommend surgery for LCIS.

“When we looked at ductal hyperplasia, fewer people thought that that qualified as cancer, and they were more likely to recommend observation,” she said.

Further, when asked to interpret the phrase “indolent lesion of epithelial origin,” which is a phrase that has been promoted as a replacement for “DCIS” in light of concerns that women are increasingly electing CPM for DCIS because of fear of the word “carcinoma” despite a 99% survival rate, only 28% of patients believed it referred to cancer.

Observation was one of the highly recommended interventions for “indolent lesion of epithelial origin,” followed by biopsy, she said, noting that only 13% recommended surgery when this phrase was used.

“Interestingly, 7.4% said an oral or topical medication [should be used for “indolent lesion of epithelial origin]” – a finding likely explained by the fact that some women interpreted the word “lesion” to mean a wound or sore on the skin, she said.

Additionally, few women were able to define contralateral prophylactic mastectomy.

Overall, despite the study population being very well educated and from a higher socioeconomic status, they had low scores for understanding terminology (8.21 out of 20), Ms. Valente noted.

The findings demonstrate that decision making in the context of DCIS remains complex and underscore the importance of recognizing patients’ knowledge of risk communication and terminology for supporting shared and informed surgical decision making, she said.

The findings also demonstrate that while fewer women felt that surgery was appropriate when the term “indolent lesion of epithelial origin” was used instead of “DCIS,” the proposed new terminology doesn’t necessarily provide the desired clarity, she noted.

“They still came up with such a broad range of interpretations that we really might be introducing a new set of conflicts and confusion when we think about changing to that terminology when we talk to patients,” she concluded.

Dr. Hamilton and Ms. Valente each reported having no disclosures.

The warning about potentially life-threatening allergic reactions with the intravenous anemia drug ferumoxytol is being strengthened to reflect cases of allergic reactions, including fatalities, associated with this drug since approval, the Food and Drug Administration announced on March 30.

Information about the risk of potentially life-threatening allergic reactions was included in the warnings and precautions section of the prescribing information for ferumoxytol (Feraheme) when it was approved in 2009, and this risk is associated with all IV iron therapies. Since approval of ferumoxytol, however, “serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures,” according to the FDA’s statement, a drug safety communication.

Ways to reduce this risk have been identified and “health care professionals should follow the new recommendations in the drug label,” which includes the new contraindication, a “strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product,” the statement said.

Other recommendations included in the revised prescribing information include instructions to administer diluted ferumoxytol in an IV infusion administered over at least 15 minutes and to never administer it as an undiluted solution; to closely monitor patients for signs and symptoms of serious allergic reactions, which includes monitoring pulse and blood pressure during administration and for at least 30 minutes after each infusion; and to “carefully consider the potential risks and benefits” of the drug in elderly patients and in patients who have multiple drug allergies, two groups of patients who may be at increased risk for serious reactions.

Between June 2009 and June 30, 2014, 79 reports of anaphylactic reactions associated with ferumoxytol were identified in people from aged 19-96 years in the FDA Adverse Event Reporting System database, of which 18 were fatal, “despite immediate medical intervention and emergency resuscitation attempts. Almost half were reported with the first dose and 60 cases – about 75% – were reported to have started during the infusion or within 5 minutes after it had been fully infused.

Of the 79 cases, 34 (43%) were reported in people with a history of drug allergy; and 24% had a history of multiple drug allergies. Cardiac arrest, hypotension, dyspnea, nausea, vomiting, and flushing were among the common symptoms described.

Serious adverse events associated with ferumoxytol or other IV iron therapies should be reported to the FDA’s MedWatch program at 800-332-1099 or on-line at https://www.accessdata.fda.gov/scripts/medwatch/.

[email protected]

The warning about potentially life-threatening allergic reactions with the intravenous anemia drug ferumoxytol is being strengthened to reflect cases of allergic reactions, including fatalities, associated with this drug since approval, the Food and Drug Administration announced on March 30.

Information about the risk of potentially life-threatening allergic reactions was included in the warnings and precautions section of the prescribing information for ferumoxytol (Feraheme) when it was approved in 2009, and this risk is associated with all IV iron therapies. Since approval of ferumoxytol, however, “serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures,” according to the FDA’s statement, a drug safety communication.

Ways to reduce this risk have been identified and “health care professionals should follow the new recommendations in the drug label,” which includes the new contraindication, a “strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product,” the statement said.

Other recommendations included in the revised prescribing information include instructions to administer diluted ferumoxytol in an IV infusion administered over at least 15 minutes and to never administer it as an undiluted solution; to closely monitor patients for signs and symptoms of serious allergic reactions, which includes monitoring pulse and blood pressure during administration and for at least 30 minutes after each infusion; and to “carefully consider the potential risks and benefits” of the drug in elderly patients and in patients who have multiple drug allergies, two groups of patients who may be at increased risk for serious reactions.

Between June 2009 and June 30, 2014, 79 reports of anaphylactic reactions associated with ferumoxytol were identified in people from aged 19-96 years in the FDA Adverse Event Reporting System database, of which 18 were fatal, “despite immediate medical intervention and emergency resuscitation attempts. Almost half were reported with the first dose and 60 cases – about 75% – were reported to have started during the infusion or within 5 minutes after it had been fully infused.

Of the 79 cases, 34 (43%) were reported in people with a history of drug allergy; and 24% had a history of multiple drug allergies. Cardiac arrest, hypotension, dyspnea, nausea, vomiting, and flushing were among the common symptoms described.

Serious adverse events associated with ferumoxytol or other IV iron therapies should be reported to the FDA’s MedWatch program at 800-332-1099 or on-line at https://www.accessdata.fda.gov/scripts/medwatch/.

[email protected]

The warning about potentially life-threatening allergic reactions with the intravenous anemia drug ferumoxytol is being strengthened to reflect cases of allergic reactions, including fatalities, associated with this drug since approval, the Food and Drug Administration announced on March 30.

Information about the risk of potentially life-threatening allergic reactions was included in the warnings and precautions section of the prescribing information for ferumoxytol (Feraheme) when it was approved in 2009, and this risk is associated with all IV iron therapies. Since approval of ferumoxytol, however, “serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures,” according to the FDA’s statement, a drug safety communication.

Ways to reduce this risk have been identified and “health care professionals should follow the new recommendations in the drug label,” which includes the new contraindication, a “strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product,” the statement said.

Other recommendations included in the revised prescribing information include instructions to administer diluted ferumoxytol in an IV infusion administered over at least 15 minutes and to never administer it as an undiluted solution; to closely monitor patients for signs and symptoms of serious allergic reactions, which includes monitoring pulse and blood pressure during administration and for at least 30 minutes after each infusion; and to “carefully consider the potential risks and benefits” of the drug in elderly patients and in patients who have multiple drug allergies, two groups of patients who may be at increased risk for serious reactions.

Between June 2009 and June 30, 2014, 79 reports of anaphylactic reactions associated with ferumoxytol were identified in people from aged 19-96 years in the FDA Adverse Event Reporting System database, of which 18 were fatal, “despite immediate medical intervention and emergency resuscitation attempts. Almost half were reported with the first dose and 60 cases – about 75% – were reported to have started during the infusion or within 5 minutes after it had been fully infused.

Of the 79 cases, 34 (43%) were reported in people with a history of drug allergy; and 24% had a history of multiple drug allergies. Cardiac arrest, hypotension, dyspnea, nausea, vomiting, and flushing were among the common symptoms described.

Serious adverse events associated with ferumoxytol or other IV iron therapies should be reported to the FDA’s MedWatch program at 800-332-1099 or on-line at https://www.accessdata.fda.gov/scripts/medwatch/.

[email protected]

The Supreme Court has declined to hear a case challenging the Independent Payment Advisory Board.

This leaves in place a ruling from the 9th U.S. Circuit Court of appeals, which dismissed the lawsuit Coons v. Lew, on the grounds that the plaintiffs failed to show harm from the provision of the Affordable Care Act that created the IPAB.

©trekandshoot/thinkstockphotos.com

The 15-member panel, created under the ACA to help control health care costs, is charged with identifying cuts to Medicare when the program’s spending exceeds gross domestic product plus 1%. Current slowing growth in Medicare spending had meant that the IPAB provision has not be triggered, and so far no members have been named to the panel.

Attorneys representing the plaintiff said they remain ready to refile their case if and when the IPAB is ever activated.

“This case is not dead; we’re simply in a holding pattern,” Christina Sandefur, senior attorney at the Goldwater Institute, said in a statement.

Congress also continues to look at the IPAB. In March, Rep. Phil Roe (R-Tenn.) reintroduced legislation to repeal the panel.

[email protected]

The Supreme Court has declined to hear a case challenging the Independent Payment Advisory Board.

This leaves in place a ruling from the 9th U.S. Circuit Court of appeals, which dismissed the lawsuit Coons v. Lew, on the grounds that the plaintiffs failed to show harm from the provision of the Affordable Care Act that created the IPAB.

©trekandshoot/thinkstockphotos.com

The 15-member panel, created under the ACA to help control health care costs, is charged with identifying cuts to Medicare when the program’s spending exceeds gross domestic product plus 1%. Current slowing growth in Medicare spending had meant that the IPAB provision has not be triggered, and so far no members have been named to the panel.

Attorneys representing the plaintiff said they remain ready to refile their case if and when the IPAB is ever activated.

“This case is not dead; we’re simply in a holding pattern,” Christina Sandefur, senior attorney at the Goldwater Institute, said in a statement.

Congress also continues to look at the IPAB. In March, Rep. Phil Roe (R-Tenn.) reintroduced legislation to repeal the panel.

[email protected]

The Supreme Court has declined to hear a case challenging the Independent Payment Advisory Board.

This leaves in place a ruling from the 9th U.S. Circuit Court of appeals, which dismissed the lawsuit Coons v. Lew, on the grounds that the plaintiffs failed to show harm from the provision of the Affordable Care Act that created the IPAB.

©trekandshoot/thinkstockphotos.com

The 15-member panel, created under the ACA to help control health care costs, is charged with identifying cuts to Medicare when the program’s spending exceeds gross domestic product plus 1%. Current slowing growth in Medicare spending had meant that the IPAB provision has not be triggered, and so far no members have been named to the panel.

Attorneys representing the plaintiff said they remain ready to refile their case if and when the IPAB is ever activated.

“This case is not dead; we’re simply in a holding pattern,” Christina Sandefur, senior attorney at the Goldwater Institute, said in a statement.

Congress also continues to look at the IPAB. In March, Rep. Phil Roe (R-Tenn.) reintroduced legislation to repeal the panel.

[email protected]

Physicians experienced no major changes in patient volume or complexity since the Affordable Care Act’s coverage expansion provisions took effect, a study shows.

Of patient encounters, 22.9% of primary care visits in 2014 were by new patients, compared with 22.6% of visits to primary care physicians in 2013, according to a study by athenahealth and funded by the Robert Wood Johnson Foundation. Similar small increases were reported for pediatricians and surgeons, while the proportion of new-patient visits remained flat for obstetricians and gynecologists.

The findings contradict widely held predictions that the ACA would drive a flood of sicker, newly insured patients into doctors’ offices, said Josh Gray, vice president of athenaResearch for athenahealth.

“Amongst other findings and counter to what many predicted, we haven’t seen a swell of new and sicker patients materialize in primary care or across specialty settings,” Mr. Gray said in a statement. “Also, there’s no evidence that providers are overwhelmed by an uptick of patients with more complex cases or chronic diseases. The findings are fascinating; it’s a front-row seat into how policy is translated into care trends, utilization, and access across the United States.”

Researchers at athenahealth reviewed data from roughly 15,700 physicians who used athenahealth’s cloud-based software from 2013 to 2014. Of the doctors, 35% were primary care physicians, 7% were pediatricians, 7% were ob.gyns, and about 12% were surgeons. The data reflect 29 million patient encounters. (The sample does not include visits to emergency departments or inpatient settings.)

For pediatricians, 22.9% of visits in 2014 were new, compared with 22.3% of visits in 2013. New visits for ob.gyns remained at 31.5% of total patient encounters in 2014, the same proportion seen in 2013. For surgeons, 50% of their patient visits were new in 2014, compared with 49.5% in 2013. For all other physicians, new-patient visits fell from 37.1% in 2013 to 36.1% in 2014.

Patients did not appear to be sicker or more complex in 2014, the study showed. Physicians’ average work relative value unit (RVU) score per patient visit remained unchanged from 2013 to 2014, at 2.3. RVUs take into account the time, skill, and intensity of treatment per patient visit. Diagnoses per visit rose slightly, from 2 in 2013 to 2.1 in 2014, while the number of high-complexity evaluation and management codes declined from 8% in 2013 to 7.5% in 2014 for all visits.

While size and complexity of patient visits remained mostly stable, the number of uninsured patients fell, particularly in states that have expanded Medicaid, the researchers found.

Among patients in Medicaid expansion states, the proportion of visits by uninsured patients to primary care physicians dropped from 4.6% in 2013 to 2.8% in 2014. For patients in states that have not expanded Medicaid, the proportion of uninsured patient visits fell from 7% in 2013 to 6.2% percent in 2014.

Although providers did not see a major rise in new patients, doctors are more likely to conduct comprehensive new-patient assessments. The proportion of visits for comprehensive evaluation and management of new patients – including taking a patient history, conducting a physical exam, and making medical decisions – increased from 6.7% in 2013 to 7% in 2014.

[email protected]

On Twitter @legal_med

Physicians experienced no major changes in patient volume or complexity since the Affordable Care Act’s coverage expansion provisions took effect, a study shows.

Of patient encounters, 22.9% of primary care visits in 2014 were by new patients, compared with 22.6% of visits to primary care physicians in 2013, according to a study by athenahealth and funded by the Robert Wood Johnson Foundation. Similar small increases were reported for pediatricians and surgeons, while the proportion of new-patient visits remained flat for obstetricians and gynecologists.

The findings contradict widely held predictions that the ACA would drive a flood of sicker, newly insured patients into doctors’ offices, said Josh Gray, vice president of athenaResearch for athenahealth.

“Amongst other findings and counter to what many predicted, we haven’t seen a swell of new and sicker patients materialize in primary care or across specialty settings,” Mr. Gray said in a statement. “Also, there’s no evidence that providers are overwhelmed by an uptick of patients with more complex cases or chronic diseases. The findings are fascinating; it’s a front-row seat into how policy is translated into care trends, utilization, and access across the United States.”

Researchers at athenahealth reviewed data from roughly 15,700 physicians who used athenahealth’s cloud-based software from 2013 to 2014. Of the doctors, 35% were primary care physicians, 7% were pediatricians, 7% were ob.gyns, and about 12% were surgeons. The data reflect 29 million patient encounters. (The sample does not include visits to emergency departments or inpatient settings.)

For pediatricians, 22.9% of visits in 2014 were new, compared with 22.3% of visits in 2013. New visits for ob.gyns remained at 31.5% of total patient encounters in 2014, the same proportion seen in 2013. For surgeons, 50% of their patient visits were new in 2014, compared with 49.5% in 2013. For all other physicians, new-patient visits fell from 37.1% in 2013 to 36.1% in 2014.

Patients did not appear to be sicker or more complex in 2014, the study showed. Physicians’ average work relative value unit (RVU) score per patient visit remained unchanged from 2013 to 2014, at 2.3. RVUs take into account the time, skill, and intensity of treatment per patient visit. Diagnoses per visit rose slightly, from 2 in 2013 to 2.1 in 2014, while the number of high-complexity evaluation and management codes declined from 8% in 2013 to 7.5% in 2014 for all visits.

While size and complexity of patient visits remained mostly stable, the number of uninsured patients fell, particularly in states that have expanded Medicaid, the researchers found.

Among patients in Medicaid expansion states, the proportion of visits by uninsured patients to primary care physicians dropped from 4.6% in 2013 to 2.8% in 2014. For patients in states that have not expanded Medicaid, the proportion of uninsured patient visits fell from 7% in 2013 to 6.2% percent in 2014.

Although providers did not see a major rise in new patients, doctors are more likely to conduct comprehensive new-patient assessments. The proportion of visits for comprehensive evaluation and management of new patients – including taking a patient history, conducting a physical exam, and making medical decisions – increased from 6.7% in 2013 to 7% in 2014.

[email protected]

On Twitter @legal_med

Physicians experienced no major changes in patient volume or complexity since the Affordable Care Act’s coverage expansion provisions took effect, a study shows.

Of patient encounters, 22.9% of primary care visits in 2014 were by new patients, compared with 22.6% of visits to primary care physicians in 2013, according to a study by athenahealth and funded by the Robert Wood Johnson Foundation. Similar small increases were reported for pediatricians and surgeons, while the proportion of new-patient visits remained flat for obstetricians and gynecologists.

The findings contradict widely held predictions that the ACA would drive a flood of sicker, newly insured patients into doctors’ offices, said Josh Gray, vice president of athenaResearch for athenahealth.

“Amongst other findings and counter to what many predicted, we haven’t seen a swell of new and sicker patients materialize in primary care or across specialty settings,” Mr. Gray said in a statement. “Also, there’s no evidence that providers are overwhelmed by an uptick of patients with more complex cases or chronic diseases. The findings are fascinating; it’s a front-row seat into how policy is translated into care trends, utilization, and access across the United States.”

Researchers at athenahealth reviewed data from roughly 15,700 physicians who used athenahealth’s cloud-based software from 2013 to 2014. Of the doctors, 35% were primary care physicians, 7% were pediatricians, 7% were ob.gyns, and about 12% were surgeons. The data reflect 29 million patient encounters. (The sample does not include visits to emergency departments or inpatient settings.)

For pediatricians, 22.9% of visits in 2014 were new, compared with 22.3% of visits in 2013. New visits for ob.gyns remained at 31.5% of total patient encounters in 2014, the same proportion seen in 2013. For surgeons, 50% of their patient visits were new in 2014, compared with 49.5% in 2013. For all other physicians, new-patient visits fell from 37.1% in 2013 to 36.1% in 2014.

Patients did not appear to be sicker or more complex in 2014, the study showed. Physicians’ average work relative value unit (RVU) score per patient visit remained unchanged from 2013 to 2014, at 2.3. RVUs take into account the time, skill, and intensity of treatment per patient visit. Diagnoses per visit rose slightly, from 2 in 2013 to 2.1 in 2014, while the number of high-complexity evaluation and management codes declined from 8% in 2013 to 7.5% in 2014 for all visits.

While size and complexity of patient visits remained mostly stable, the number of uninsured patients fell, particularly in states that have expanded Medicaid, the researchers found.

Among patients in Medicaid expansion states, the proportion of visits by uninsured patients to primary care physicians dropped from 4.6% in 2013 to 2.8% in 2014. For patients in states that have not expanded Medicaid, the proportion of uninsured patient visits fell from 7% in 2013 to 6.2% percent in 2014.

Although providers did not see a major rise in new patients, doctors are more likely to conduct comprehensive new-patient assessments. The proportion of visits for comprehensive evaluation and management of new patients – including taking a patient history, conducting a physical exam, and making medical decisions – increased from 6.7% in 2013 to 7% in 2014.

[email protected]

On Twitter @legal_med

A mixture of eight probiotic bacterial strains only somewhat outperformed placebo for preventing endoscopic recurrence after ileal resection in Crohn’s disease patients, according to a multicenter, randomized trial.

After 90 days of treatment, 9.3% of patients who received the probiotic mixture (VSL#3) had developed severe endoscopic recurrence, compared with 15.7% of the placebo group (P = .19), reported Dr. Richard Fedorak of the University of Alberta, Edmonton, and his associates.

The recurrence rate for the placebo group was about two-thirds lower than what the researchers had expected based on the sample size calculation, they noted. But the probiotic blend was linked to significantly significant decreases in colonic mucosal levels of proinflammatory cytokines, they reported (Clin. Gastroenterol. Hepatol. 2014 Nov. 6 [doi:10.1016/j.cgh.2014.10.031]).

Investigators have tested probiotics as a preventive therapy for Crohn’s disease because patients with active disease have less diverse intestinal microbiota, compared with those with quiescent disease or healthy controls. Past studies of single-strain probiotics have shown them to be no better than placebo for preventing endoscopic recurrence.

But in one small study, rifampin followed by VSL#3 outperformed mesalamine at 1 year (Gastroenterology 2000;118:A781), the researchers noted. “This mixture could confer protective effects where single-strain or lactobacillus-only formulations had failed,” they hypothesized.

To test that theory, the investigators randomized 120 patients with Crohn’s disease who had undergone ileal resection and ileocolonic anastomosis to twice-daily VSL#3 or placebo. Treatment began within 30 days after surgery and continued for 90 days, after which all patients received open-label VSL#3 for another 9 months.

Among patients who had nonsevere endoscopic lesions at day 90, 1-year rates of severe endoscopic recurrence were 10% for the early VSL#3 group, compared with 26.7% for the late VSL#3 group (P = .09), said the researchers. Likewise, combined rates of severe recurrence on days 90 and 365 were not statistically different, they reported. However, the early VSL#3 group had lower mucosal levels of 13 pro-inflammatory cytokines, compared with patients who received placebo until day 90 (P < .05). Measures of Crohn’s disease activity and disease-related quality of life scores were similar for both groups.

“Early treatment with VSL#3 had a larger effect than late treatment,” concluded the investigators. “Future larger studies will be needed to confirm the effect of VSL#3 in prevention of postoperative recurrence.”

The study was funded by VSL Pharmaceuticals, the Canadian Institutes of Health Research, and Crohn’s and Colitis Foundation of Canada. Dr. Fedorak reported having served on a speakers bureau for VSL Pharmaceuticals. The other authors declared no relevant conflicts of interest.

A mixture of eight probiotic bacterial strains only somewhat outperformed placebo for preventing endoscopic recurrence after ileal resection in Crohn’s disease patients, according to a multicenter, randomized trial.

After 90 days of treatment, 9.3% of patients who received the probiotic mixture (VSL#3) had developed severe endoscopic recurrence, compared with 15.7% of the placebo group (P = .19), reported Dr. Richard Fedorak of the University of Alberta, Edmonton, and his associates.

The recurrence rate for the placebo group was about two-thirds lower than what the researchers had expected based on the sample size calculation, they noted. But the probiotic blend was linked to significantly significant decreases in colonic mucosal levels of proinflammatory cytokines, they reported (Clin. Gastroenterol. Hepatol. 2014 Nov. 6 [doi:10.1016/j.cgh.2014.10.031]).

Investigators have tested probiotics as a preventive therapy for Crohn’s disease because patients with active disease have less diverse intestinal microbiota, compared with those with quiescent disease or healthy controls. Past studies of single-strain probiotics have shown them to be no better than placebo for preventing endoscopic recurrence.

But in one small study, rifampin followed by VSL#3 outperformed mesalamine at 1 year (Gastroenterology 2000;118:A781), the researchers noted. “This mixture could confer protective effects where single-strain or lactobacillus-only formulations had failed,” they hypothesized.

To test that theory, the investigators randomized 120 patients with Crohn’s disease who had undergone ileal resection and ileocolonic anastomosis to twice-daily VSL#3 or placebo. Treatment began within 30 days after surgery and continued for 90 days, after which all patients received open-label VSL#3 for another 9 months.

Among patients who had nonsevere endoscopic lesions at day 90, 1-year rates of severe endoscopic recurrence were 10% for the early VSL#3 group, compared with 26.7% for the late VSL#3 group (P = .09), said the researchers. Likewise, combined rates of severe recurrence on days 90 and 365 were not statistically different, they reported. However, the early VSL#3 group had lower mucosal levels of 13 pro-inflammatory cytokines, compared with patients who received placebo until day 90 (P < .05). Measures of Crohn’s disease activity and disease-related quality of life scores were similar for both groups.

“Early treatment with VSL#3 had a larger effect than late treatment,” concluded the investigators. “Future larger studies will be needed to confirm the effect of VSL#3 in prevention of postoperative recurrence.”

The study was funded by VSL Pharmaceuticals, the Canadian Institutes of Health Research, and Crohn’s and Colitis Foundation of Canada. Dr. Fedorak reported having served on a speakers bureau for VSL Pharmaceuticals. The other authors declared no relevant conflicts of interest.

A mixture of eight probiotic bacterial strains only somewhat outperformed placebo for preventing endoscopic recurrence after ileal resection in Crohn’s disease patients, according to a multicenter, randomized trial.

After 90 days of treatment, 9.3% of patients who received the probiotic mixture (VSL#3) had developed severe endoscopic recurrence, compared with 15.7% of the placebo group (P = .19), reported Dr. Richard Fedorak of the University of Alberta, Edmonton, and his associates.

The recurrence rate for the placebo group was about two-thirds lower than what the researchers had expected based on the sample size calculation, they noted. But the probiotic blend was linked to significantly significant decreases in colonic mucosal levels of proinflammatory cytokines, they reported (Clin. Gastroenterol. Hepatol. 2014 Nov. 6 [doi:10.1016/j.cgh.2014.10.031]).

Investigators have tested probiotics as a preventive therapy for Crohn’s disease because patients with active disease have less diverse intestinal microbiota, compared with those with quiescent disease or healthy controls. Past studies of single-strain probiotics have shown them to be no better than placebo for preventing endoscopic recurrence.

But in one small study, rifampin followed by VSL#3 outperformed mesalamine at 1 year (Gastroenterology 2000;118:A781), the researchers noted. “This mixture could confer protective effects where single-strain or lactobacillus-only formulations had failed,” they hypothesized.

To test that theory, the investigators randomized 120 patients with Crohn’s disease who had undergone ileal resection and ileocolonic anastomosis to twice-daily VSL#3 or placebo. Treatment began within 30 days after surgery and continued for 90 days, after which all patients received open-label VSL#3 for another 9 months.

Among patients who had nonsevere endoscopic lesions at day 90, 1-year rates of severe endoscopic recurrence were 10% for the early VSL#3 group, compared with 26.7% for the late VSL#3 group (P = .09), said the researchers. Likewise, combined rates of severe recurrence on days 90 and 365 were not statistically different, they reported. However, the early VSL#3 group had lower mucosal levels of 13 pro-inflammatory cytokines, compared with patients who received placebo until day 90 (P < .05). Measures of Crohn’s disease activity and disease-related quality of life scores were similar for both groups.

“Early treatment with VSL#3 had a larger effect than late treatment,” concluded the investigators. “Future larger studies will be needed to confirm the effect of VSL#3 in prevention of postoperative recurrence.”

The study was funded by VSL Pharmaceuticals, the Canadian Institutes of Health Research, and Crohn’s and Colitis Foundation of Canada. Dr. Fedorak reported having served on a speakers bureau for VSL Pharmaceuticals. The other authors declared no relevant conflicts of interest.

The Affordable Care Act’s requirement that health insurers pay out a minimum percentage of premiums in medical claims or quality improvement generated $5 billion in savings from 2011 to 2013, according to the Commonwealth Fund.

However, insurance companies were not increasing spending on quality improvements during that period, according to a report released March 26.

Under the ACA, insurers who fail to meet minimum percentages of premiums paid as claims must rebate the difference to consumers.

thinkstockphotos.com

In 2011, insurers paid $1.1 billion in rebates, researchers found. That figured dropped to $325 million in 2013, with the rebate total across the 3-year period being nearly $2 billion. The remaining $3 billion was generated from reductions in administrative costs without any increase in net profits during that time period.

The decline in consumer rebates reflects “greater compliance with the [medical loss ratio] rule,” the report’s authors noted, and “that insurers are spending a larger percentage of premium dollars on medical claims.”

The report noted that insurers could spend premium dollars on quality improvement to meet requirements – but in 2013, those quality improvement expenses remained at just below 1% and were relatively steady during the study period.

[email protected]

The Affordable Care Act’s requirement that health insurers pay out a minimum percentage of premiums in medical claims or quality improvement generated $5 billion in savings from 2011 to 2013, according to the Commonwealth Fund.

However, insurance companies were not increasing spending on quality improvements during that period, according to a report released March 26.

Under the ACA, insurers who fail to meet minimum percentages of premiums paid as claims must rebate the difference to consumers.

thinkstockphotos.com

In 2011, insurers paid $1.1 billion in rebates, researchers found. That figured dropped to $325 million in 2013, with the rebate total across the 3-year period being nearly $2 billion. The remaining $3 billion was generated from reductions in administrative costs without any increase in net profits during that time period.

The decline in consumer rebates reflects “greater compliance with the [medical loss ratio] rule,” the report’s authors noted, and “that insurers are spending a larger percentage of premium dollars on medical claims.”

The report noted that insurers could spend premium dollars on quality improvement to meet requirements – but in 2013, those quality improvement expenses remained at just below 1% and were relatively steady during the study period.

[email protected]

The Affordable Care Act’s requirement that health insurers pay out a minimum percentage of premiums in medical claims or quality improvement generated $5 billion in savings from 2011 to 2013, according to the Commonwealth Fund.

However, insurance companies were not increasing spending on quality improvements during that period, according to a report released March 26.

Under the ACA, insurers who fail to meet minimum percentages of premiums paid as claims must rebate the difference to consumers.

thinkstockphotos.com

In 2011, insurers paid $1.1 billion in rebates, researchers found. That figured dropped to $325 million in 2013, with the rebate total across the 3-year period being nearly $2 billion. The remaining $3 billion was generated from reductions in administrative costs without any increase in net profits during that time period.

The decline in consumer rebates reflects “greater compliance with the [medical loss ratio] rule,” the report’s authors noted, and “that insurers are spending a larger percentage of premium dollars on medical claims.”

The report noted that insurers could spend premium dollars on quality improvement to meet requirements – but in 2013, those quality improvement expenses remained at just below 1% and were relatively steady during the study period.

[email protected]