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Rural patients less likely to have bariatric surgery
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
FROM SURGERY FOR OBESITY AND RELATED DISEASES
Key clinical point: Obese patients living in rural areas of West Virginia are substantially less likely than are their urban and suburban counterparts to have bariatric surgery.
Major finding: Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference.
Data source: A retrospective single-center cohort study involving 122 obese West Virginians seeking bariatric surgery in 2012-2014.
Disclosures: No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
VIDEO: Metastatic Trial Search links MBC patients to relevant trials
CHICAGO – Metastatic Trial Search was launched in 2015 by ClinicalTrials.org to make it easier for patients with metastatic breast cancer to consider clinical trials as a routine option as they are making treatment decisions with their physicians.
In a video interview, Shirley A. Mertz, JD, president of the Metastatic Breast Cancer Network, describes the tool, the mixed response from physicians, the barriers to trial participation still faced by patients, and the tweaked version 2.0 of the search tool, expected to launch by the end of this year.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @nikolaideslaura
CHICAGO – Metastatic Trial Search was launched in 2015 by ClinicalTrials.org to make it easier for patients with metastatic breast cancer to consider clinical trials as a routine option as they are making treatment decisions with their physicians.
In a video interview, Shirley A. Mertz, JD, president of the Metastatic Breast Cancer Network, describes the tool, the mixed response from physicians, the barriers to trial participation still faced by patients, and the tweaked version 2.0 of the search tool, expected to launch by the end of this year.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @nikolaideslaura
CHICAGO – Metastatic Trial Search was launched in 2015 by ClinicalTrials.org to make it easier for patients with metastatic breast cancer to consider clinical trials as a routine option as they are making treatment decisions with their physicians.
In a video interview, Shirley A. Mertz, JD, president of the Metastatic Breast Cancer Network, describes the tool, the mixed response from physicians, the barriers to trial participation still faced by patients, and the tweaked version 2.0 of the search tool, expected to launch by the end of this year.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @nikolaideslaura
AT ASCO 2017
Waiving screening copayments could cut colorectal cancer deaths
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
AT DDW
The perils of the National Practitioner Data Bank
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Study sheds light on pregnancy outcomes following ocrelizumab treatment
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
NEW ORLEANS – Data from the ocrelizumab clinical development program gives clinicians a first look at pregnancy outcomes after exposure to the drug, but the small size limits the ability to draw firm conclusions.
In the United States, prescribing information for ocrelizumab states that women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion. At the annual meeting of the Consortium of Multiple Sclerosis Centers, researchers led by Sibyl Wray, MD, set out to assess the pregnancy, fetal, neonatal and infant outcomes in patients who became pregnant during ocrelizumab trials in MS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) through Sept. 15, 2015.
The analysis included ocrelizumab-exposed women in primarily European-based clinical trials in patients with MS, RA, or SLE, in whom doses ranged from 20 mg to 2,000 mg. These included three randomized trials of its use in MS, totaling 1,876 patients with a mean age of 40 years; four trials of its use in RA, totaling 2,759 patients with a mean age of 53 years; and one trial of its use in SLE, totaling 381 patients with a mean age of 31 years. Between 2008 and Sept. 14, 2015, a total of 48 women who were enrolled in the trials reported pregnancies.
MS data
Of the 15 pregnancies in the MS trials, three involved the delivery of full term, healthy newborns. In one case, the last ocrelizumab infusion was given 28 months before conception. In the second case, an infusion was given 20 weeks before conception, and a further infusion was given 17 days after conception. In the third case, the last ocrelizumab infusion was given 26.5 weeks before conception.
One live term birth occurred with an abnormal finding. In this case, the last infusion of ocrelizumab was 23 weeks prior to the last menstrual period or about 6 months prior to conception. The embryo/fetus was not exposed to the drug in utero. The researchers also found that seven elective terminations occurred among MS patients and that four pregnancies were ongoing at the time of this report.
“We have to be cautious because we don’t have enough data yet to know, but it’s encouraging to see that, if you follow the guidelines, the patient population and the newborns seem to be healthy in these exposed individuals,” Dr. Wray said.
RA data
Data from the RA clinical trials revealed 22 pregnancies in 21 patients exposed to ocrelizumab. Of these, eight pregnancies resulted in healthy term babies; four resulted in live births with abnormal findings (structural malformation, growth abnormality) or preterm birth; and eight pregnancies in seven women resulted in spontaneous abortion (one patient experienced a spontaneous abortion on two occasions), missed abortion, or an embryonic pregnancy. One pregnancy was lost to follow-up and another resulted in elective termination.
SLE data
During the SLE trials, 11 pregnancies occurred in 10 patients. Three pregnancies in two women resulted in healthy term babies. Three other pregnancies resulted in live births with an abnormal finding (structural malformation, functional deficit, growth abnormality) and/or preterm birth. Two pregnancies resulted in spontaneous/missed abortion. One pregnancy resulted in fetal death at 7.5 months’ gestation secondary to fatal pulmonary embolism in the mother; one pregnancy resulted in elective termination; and one pregnancy resulted in a healthy baby born at an unknown gestational week.
Dr. Wray emphasized that the small numbers of patients studied make it difficult to draw conclusions about pregnancy outcomes following ocrelizumab in patients with MS and other autoimmune diseases. “We need to pay attention to the half-life of this drug, the time it takes to clear, and how to plan pregnancies around that,” she said. She noted that pregnancy outcomes in ongoing ocrelizumab studies and postmarketing experiences will continue to be collected and assessed.
The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
AT THE CMSC ANNUAL MEETING
Key clinical point:
Major finding: Of 15 pregnancies in the MS trials, three involved the delivery of three full term, healthy newborns; one live term birth occurred with an abnormal finding; seven elective terminations occurred; and four pregnancies were ongoing.
Data source: A review of 48 pregnancies among women enrolled in clinical trials for ocrelizumab in MS, rheumatoid arthritis, and systemic lupus erythematosus.
Disclosures: The study was funded by Roche, Basel, Switzerland. Dr. Wray reported that she has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme/Sanofi, Novartis, and TG Therapeutics.
Politics and Planned Parenthood
WHAT LIES AHEAD FOR WOMEN’S HEALTH? CHALLENGES, AND OPPORTUNITIES, AS ACOG AND US LEADERSHIP TRANSITION
LUCIA DIVENERE, MA
Politics and Planned Parenthood
As obstetricians and gynecologists, we are all dedicated to women's health care. Many of us are Pro-Life and resent your unqualified support of Planned Parenthood, the world’s largest provider and supporter of unrestricted abortion. There are many venues to deliver women's health care. We should not be cheerleaders for the Planned Parenthood/Democratic party propaganda. As you stated, we should be truly a-political.
Laurence Burns, DO
Grand Rapids, Michigan
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
WHAT LIES AHEAD FOR WOMEN’S HEALTH? CHALLENGES, AND OPPORTUNITIES, AS ACOG AND US LEADERSHIP TRANSITION
LUCIA DIVENERE, MA
Politics and Planned Parenthood
As obstetricians and gynecologists, we are all dedicated to women's health care. Many of us are Pro-Life and resent your unqualified support of Planned Parenthood, the world’s largest provider and supporter of unrestricted abortion. There are many venues to deliver women's health care. We should not be cheerleaders for the Planned Parenthood/Democratic party propaganda. As you stated, we should be truly a-political.
Laurence Burns, DO
Grand Rapids, Michigan
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
WHAT LIES AHEAD FOR WOMEN’S HEALTH? CHALLENGES, AND OPPORTUNITIES, AS ACOG AND US LEADERSHIP TRANSITION
LUCIA DIVENERE, MA
Politics and Planned Parenthood
As obstetricians and gynecologists, we are all dedicated to women's health care. Many of us are Pro-Life and resent your unqualified support of Planned Parenthood, the world’s largest provider and supporter of unrestricted abortion. There are many venues to deliver women's health care. We should not be cheerleaders for the Planned Parenthood/Democratic party propaganda. As you stated, we should be truly a-political.
Laurence Burns, DO
Grand Rapids, Michigan
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
BMS recalls a lot of Eliquis 5 mg tablets
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Whole blood PCR improves diagnosis of pediatric bacterial sepsis
MADRID – Whole blood multiplex polymerase chain reaction (PCR) holds considerable promise as a rapid noninvasive test to improve diagnosis of life-threatening bacterial infections in children with suspected sepsis yet negative blood cultures, Clare Thakker, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
There are several disadvantages with blood cultures – the current diagnostic standard. The turnaround time is 48 hours or longer. Moreover, false-negative culture results are common because of prior antibiotic therapy. And blood cultures require a considerable amount of blood, which becomes an issue in younger children with small blood volumes. Whole blood PCR is unfettered by these limitations, and it could reduce the need for invasive sampling, such as pleural or joint aspiration or CSF sampling, in blood culture–negative children, observed Dr. Thakker of Imperial College London.
The challenge posed by febrile children is that even though the vast majority will turn out to have a self-limited viral illness, a small proportion will have a life-threatening bacterial infection. And distinguishing between the two groups in timely fashion often remains difficult today, the pediatrician said.
Dr. Thakker reported on 504 EUCLIDS participants with suspected sepsis who had blood cultures and whole blood PCR testing done on the same day. The multiplex PCR, developed by Micropathology of Coventry, England, was set up to test simultaneously for five clinically important bacterial pathogens: Neisseria meningitidis, Streptococcus pneumoniae, S. pyogenes, Staphylococcus aureus, and Haemophilus influenzae. Prior to testing, the blood samples underwent lysozyme/lysostaphin digestion and silica bead disruption in order to break down cell walls and facilitate nucleic acid extraction.
Of the 504 children with suspected sepsis, 438 (87%) had negative blood cultures, among whom were 326 patients (74%) with clinically suspected or definite bacterial infection. The PCR test identified one of the five target pathogens in 25 of the 326 patients (8%) where physicians suspected bacterial sepsis despite negative cultures. Ten blood culture-negative patients (40%) were whole blood PCR positive for N. meningitidis, 6 (24%) for H. influenzae, 5 (20%) for S. pneumoniae, 3 (12%) for S. aureus, and 1 (4%) for S. pyogenes. Three of the 25 positive tests showed poor clinical correlation consistent with environmental contamination. The other 22 positive PCR results were consistent with the patient’s clinical syndrome – for example, N. meningitidis being found in the blood of a child with meningeal encephalitis – or concordant with the results of a culture obtained invasively at a sterile body site.
Ninety-two patients with negative blood cultures were culture positive for a causative bacterial pathogen obtained by invasive sampling of a sterile body site such as the CSF. In 68 of these 92 cases (74%), the pathogen was among those on the multiplex PCR panel.
“Our study results bring into question whether blood culture should be the gold standard; clearly, blood culture is not capturing everything. Our findings also highlight the need for developing additional diagnostic markers, maybe based upon the host inflammatory response, to delineate which of these detections are pathogens and which are passengers,” Dr. Thakker said.
She reported having no relevant financial conflicts regarding the European Union–sponsored study.
MADRID – Whole blood multiplex polymerase chain reaction (PCR) holds considerable promise as a rapid noninvasive test to improve diagnosis of life-threatening bacterial infections in children with suspected sepsis yet negative blood cultures, Clare Thakker, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
There are several disadvantages with blood cultures – the current diagnostic standard. The turnaround time is 48 hours or longer. Moreover, false-negative culture results are common because of prior antibiotic therapy. And blood cultures require a considerable amount of blood, which becomes an issue in younger children with small blood volumes. Whole blood PCR is unfettered by these limitations, and it could reduce the need for invasive sampling, such as pleural or joint aspiration or CSF sampling, in blood culture–negative children, observed Dr. Thakker of Imperial College London.
The challenge posed by febrile children is that even though the vast majority will turn out to have a self-limited viral illness, a small proportion will have a life-threatening bacterial infection. And distinguishing between the two groups in timely fashion often remains difficult today, the pediatrician said.
Dr. Thakker reported on 504 EUCLIDS participants with suspected sepsis who had blood cultures and whole blood PCR testing done on the same day. The multiplex PCR, developed by Micropathology of Coventry, England, was set up to test simultaneously for five clinically important bacterial pathogens: Neisseria meningitidis, Streptococcus pneumoniae, S. pyogenes, Staphylococcus aureus, and Haemophilus influenzae. Prior to testing, the blood samples underwent lysozyme/lysostaphin digestion and silica bead disruption in order to break down cell walls and facilitate nucleic acid extraction.
Of the 504 children with suspected sepsis, 438 (87%) had negative blood cultures, among whom were 326 patients (74%) with clinically suspected or definite bacterial infection. The PCR test identified one of the five target pathogens in 25 of the 326 patients (8%) where physicians suspected bacterial sepsis despite negative cultures. Ten blood culture-negative patients (40%) were whole blood PCR positive for N. meningitidis, 6 (24%) for H. influenzae, 5 (20%) for S. pneumoniae, 3 (12%) for S. aureus, and 1 (4%) for S. pyogenes. Three of the 25 positive tests showed poor clinical correlation consistent with environmental contamination. The other 22 positive PCR results were consistent with the patient’s clinical syndrome – for example, N. meningitidis being found in the blood of a child with meningeal encephalitis – or concordant with the results of a culture obtained invasively at a sterile body site.
Ninety-two patients with negative blood cultures were culture positive for a causative bacterial pathogen obtained by invasive sampling of a sterile body site such as the CSF. In 68 of these 92 cases (74%), the pathogen was among those on the multiplex PCR panel.
“Our study results bring into question whether blood culture should be the gold standard; clearly, blood culture is not capturing everything. Our findings also highlight the need for developing additional diagnostic markers, maybe based upon the host inflammatory response, to delineate which of these detections are pathogens and which are passengers,” Dr. Thakker said.
She reported having no relevant financial conflicts regarding the European Union–sponsored study.
MADRID – Whole blood multiplex polymerase chain reaction (PCR) holds considerable promise as a rapid noninvasive test to improve diagnosis of life-threatening bacterial infections in children with suspected sepsis yet negative blood cultures, Clare Thakker, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
There are several disadvantages with blood cultures – the current diagnostic standard. The turnaround time is 48 hours or longer. Moreover, false-negative culture results are common because of prior antibiotic therapy. And blood cultures require a considerable amount of blood, which becomes an issue in younger children with small blood volumes. Whole blood PCR is unfettered by these limitations, and it could reduce the need for invasive sampling, such as pleural or joint aspiration or CSF sampling, in blood culture–negative children, observed Dr. Thakker of Imperial College London.
The challenge posed by febrile children is that even though the vast majority will turn out to have a self-limited viral illness, a small proportion will have a life-threatening bacterial infection. And distinguishing between the two groups in timely fashion often remains difficult today, the pediatrician said.
Dr. Thakker reported on 504 EUCLIDS participants with suspected sepsis who had blood cultures and whole blood PCR testing done on the same day. The multiplex PCR, developed by Micropathology of Coventry, England, was set up to test simultaneously for five clinically important bacterial pathogens: Neisseria meningitidis, Streptococcus pneumoniae, S. pyogenes, Staphylococcus aureus, and Haemophilus influenzae. Prior to testing, the blood samples underwent lysozyme/lysostaphin digestion and silica bead disruption in order to break down cell walls and facilitate nucleic acid extraction.
Of the 504 children with suspected sepsis, 438 (87%) had negative blood cultures, among whom were 326 patients (74%) with clinically suspected or definite bacterial infection. The PCR test identified one of the five target pathogens in 25 of the 326 patients (8%) where physicians suspected bacterial sepsis despite negative cultures. Ten blood culture-negative patients (40%) were whole blood PCR positive for N. meningitidis, 6 (24%) for H. influenzae, 5 (20%) for S. pneumoniae, 3 (12%) for S. aureus, and 1 (4%) for S. pyogenes. Three of the 25 positive tests showed poor clinical correlation consistent with environmental contamination. The other 22 positive PCR results were consistent with the patient’s clinical syndrome – for example, N. meningitidis being found in the blood of a child with meningeal encephalitis – or concordant with the results of a culture obtained invasively at a sterile body site.
Ninety-two patients with negative blood cultures were culture positive for a causative bacterial pathogen obtained by invasive sampling of a sterile body site such as the CSF. In 68 of these 92 cases (74%), the pathogen was among those on the multiplex PCR panel.
“Our study results bring into question whether blood culture should be the gold standard; clearly, blood culture is not capturing everything. Our findings also highlight the need for developing additional diagnostic markers, maybe based upon the host inflammatory response, to delineate which of these detections are pathogens and which are passengers,” Dr. Thakker said.
She reported having no relevant financial conflicts regarding the European Union–sponsored study.
AT ESPID 2017
Key clinical point:
Major finding: Twenty-five of 326 children (8%) clinically suspected of having bacterial sepsis despite negative blood cultures proved positive for one of five important bacterial pathogens upon whole blood multiplex PCR testing .
Data source: EUCLIDS, a large, ongoing, 5-year international genomic study aimed at learning why some children with a bacterial infection develop serious illness while others do not.
Disclosures: The European Union sponsored the study. Dr. Thakker reported having no relevant financial conflicts.
Identifying type 1 diabetes drivers at risk of mishaps
A risk assessment score could help identify individuals with type 1 diabetes who are at higher risk of driving mishaps and who may benefit from interventions to reduce their risk, a new study suggests.
Writing in the June edition of Diabetes Care, Daniel J. Cox, MD, of the University of Virginia, Charlottesville, and his coauthors reported on their efforts to develop and validate a “Risk Assessment of Diabetic Drivers” (RADD) scoring system.
In the first part of the two-part study, 1,371 drivers with type 1 diabetes filled out a series of questionnaires about diabetes and driving, then recorded their driving mishaps over the subsequent year (Diabetes Care. 2017;40:742-50).
This revealed that annual driving distance, peripheral neuropathy, number of past hypoglycemia-related driving mishaps, and the degree to which the individual is bothered by hypoglycemia in general were all significantly associated with a risk of future driving incidents.
Based on this, the authors developed a scoring system using these factors and identified the optimum cut-off point for maximum sensitivity and specificity.
“The area under the curve, a global measure of model performance, was estimated to be 0.73, indicating that the model performed better than chance at classifying participants into the two risk categories,” the authors wrote.
When applied to the original participants, the model classified 37.5% of them as being high-risk. This group had an average of 3.03 driving mishaps over the 12-month follow-up, compared with 0.87 mishaps in the participants who fell into the lowest 37.5% of risk (P = .002).
In the second part of the study, 1,737 drivers with type 1 diabetes completed a version of the scoring questionnaire online, and 118 low-risk and 372 high-risk individuals were recruited.
The high-risk individuals were randomized either to a 2-month online intervention that aimed at helping people with type 1 diabetes anticipate, prevent, detect, and treat hypoglycemia while driving, as well as a program of motivational interviewing, the online intervention alone, or routine care, with 12 months of follow-up. The low-risk individuals all received routine care only.
As with the first part of the study, researchers saw a significantly lower number of driving mishaps in the low-risk participants, compared with the high-risk participants (1.65 mishaps per driver per year vs. 4.26 mishaps per driver per year; P less than .001).
After adjusting for other factors such as age, sex, method of insulin delivery, and hypoglycemia awareness, the rate of mishaps was still 2.83 times higher in the high-risk group, compared with the low-risk group (P less than .001).
The authors noted that their RADD scoring system did have a false-negative rate of 24%, classifying people as low-risk even though they reported more than one driving mishap in the following 12 months.
“This illustrates that any driver has a risk of being involved in a collision or receiving a citation, and any driver with type 1 diabetes has the additional risk of experiencing disruptive extreme [blood glucose (BG)] that can result in a mishap while driving,” they wrote. “While, ideally, all drivers with type 1 diabetes should measure their BG before driving, they should at least be counseled that, whenever they take more insulin, eat fewer carbohydrates, or engage in more physical activity than usual, they should measure their BG before driving.”
With respect to the impact of the intervention and motivational interviewing, researchers found no significant differences in the rate of mishaps between the groups who received intervention plus interview and those who received the intervention alone, and, as a result, combined these two groups into one.
The high-risk group who underwent the online intervention had fewer driving mishaps than did the high-risk group who received routine care. However, they still had 1.58 times more incidents than did the low-risk individuals who received routine care.
The intervention decreased the risk of mishaps associated with hypoglycemia in high-risk individuals, compared with that in those who recieved routine care, but these individuals still had a higher incidence of hypoglycemia-associated mishaps, compared with the low-risk individuals.
“It is also important to note that [the online intervention] only affected hypoglycemia-related driving mishaps, not hyperglycemia- or nondiabetes-related mishaps,” the authors wrote.
The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
A risk assessment score could help identify individuals with type 1 diabetes who are at higher risk of driving mishaps and who may benefit from interventions to reduce their risk, a new study suggests.
Writing in the June edition of Diabetes Care, Daniel J. Cox, MD, of the University of Virginia, Charlottesville, and his coauthors reported on their efforts to develop and validate a “Risk Assessment of Diabetic Drivers” (RADD) scoring system.
In the first part of the two-part study, 1,371 drivers with type 1 diabetes filled out a series of questionnaires about diabetes and driving, then recorded their driving mishaps over the subsequent year (Diabetes Care. 2017;40:742-50).
This revealed that annual driving distance, peripheral neuropathy, number of past hypoglycemia-related driving mishaps, and the degree to which the individual is bothered by hypoglycemia in general were all significantly associated with a risk of future driving incidents.
Based on this, the authors developed a scoring system using these factors and identified the optimum cut-off point for maximum sensitivity and specificity.
“The area under the curve, a global measure of model performance, was estimated to be 0.73, indicating that the model performed better than chance at classifying participants into the two risk categories,” the authors wrote.
When applied to the original participants, the model classified 37.5% of them as being high-risk. This group had an average of 3.03 driving mishaps over the 12-month follow-up, compared with 0.87 mishaps in the participants who fell into the lowest 37.5% of risk (P = .002).
In the second part of the study, 1,737 drivers with type 1 diabetes completed a version of the scoring questionnaire online, and 118 low-risk and 372 high-risk individuals were recruited.
The high-risk individuals were randomized either to a 2-month online intervention that aimed at helping people with type 1 diabetes anticipate, prevent, detect, and treat hypoglycemia while driving, as well as a program of motivational interviewing, the online intervention alone, or routine care, with 12 months of follow-up. The low-risk individuals all received routine care only.
As with the first part of the study, researchers saw a significantly lower number of driving mishaps in the low-risk participants, compared with the high-risk participants (1.65 mishaps per driver per year vs. 4.26 mishaps per driver per year; P less than .001).
After adjusting for other factors such as age, sex, method of insulin delivery, and hypoglycemia awareness, the rate of mishaps was still 2.83 times higher in the high-risk group, compared with the low-risk group (P less than .001).
The authors noted that their RADD scoring system did have a false-negative rate of 24%, classifying people as low-risk even though they reported more than one driving mishap in the following 12 months.
“This illustrates that any driver has a risk of being involved in a collision or receiving a citation, and any driver with type 1 diabetes has the additional risk of experiencing disruptive extreme [blood glucose (BG)] that can result in a mishap while driving,” they wrote. “While, ideally, all drivers with type 1 diabetes should measure their BG before driving, they should at least be counseled that, whenever they take more insulin, eat fewer carbohydrates, or engage in more physical activity than usual, they should measure their BG before driving.”
With respect to the impact of the intervention and motivational interviewing, researchers found no significant differences in the rate of mishaps between the groups who received intervention plus interview and those who received the intervention alone, and, as a result, combined these two groups into one.
The high-risk group who underwent the online intervention had fewer driving mishaps than did the high-risk group who received routine care. However, they still had 1.58 times more incidents than did the low-risk individuals who received routine care.
The intervention decreased the risk of mishaps associated with hypoglycemia in high-risk individuals, compared with that in those who recieved routine care, but these individuals still had a higher incidence of hypoglycemia-associated mishaps, compared with the low-risk individuals.
“It is also important to note that [the online intervention] only affected hypoglycemia-related driving mishaps, not hyperglycemia- or nondiabetes-related mishaps,” the authors wrote.
The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
A risk assessment score could help identify individuals with type 1 diabetes who are at higher risk of driving mishaps and who may benefit from interventions to reduce their risk, a new study suggests.
Writing in the June edition of Diabetes Care, Daniel J. Cox, MD, of the University of Virginia, Charlottesville, and his coauthors reported on their efforts to develop and validate a “Risk Assessment of Diabetic Drivers” (RADD) scoring system.
In the first part of the two-part study, 1,371 drivers with type 1 diabetes filled out a series of questionnaires about diabetes and driving, then recorded their driving mishaps over the subsequent year (Diabetes Care. 2017;40:742-50).
This revealed that annual driving distance, peripheral neuropathy, number of past hypoglycemia-related driving mishaps, and the degree to which the individual is bothered by hypoglycemia in general were all significantly associated with a risk of future driving incidents.
Based on this, the authors developed a scoring system using these factors and identified the optimum cut-off point for maximum sensitivity and specificity.
“The area under the curve, a global measure of model performance, was estimated to be 0.73, indicating that the model performed better than chance at classifying participants into the two risk categories,” the authors wrote.
When applied to the original participants, the model classified 37.5% of them as being high-risk. This group had an average of 3.03 driving mishaps over the 12-month follow-up, compared with 0.87 mishaps in the participants who fell into the lowest 37.5% of risk (P = .002).
In the second part of the study, 1,737 drivers with type 1 diabetes completed a version of the scoring questionnaire online, and 118 low-risk and 372 high-risk individuals were recruited.
The high-risk individuals were randomized either to a 2-month online intervention that aimed at helping people with type 1 diabetes anticipate, prevent, detect, and treat hypoglycemia while driving, as well as a program of motivational interviewing, the online intervention alone, or routine care, with 12 months of follow-up. The low-risk individuals all received routine care only.
As with the first part of the study, researchers saw a significantly lower number of driving mishaps in the low-risk participants, compared with the high-risk participants (1.65 mishaps per driver per year vs. 4.26 mishaps per driver per year; P less than .001).
After adjusting for other factors such as age, sex, method of insulin delivery, and hypoglycemia awareness, the rate of mishaps was still 2.83 times higher in the high-risk group, compared with the low-risk group (P less than .001).
The authors noted that their RADD scoring system did have a false-negative rate of 24%, classifying people as low-risk even though they reported more than one driving mishap in the following 12 months.
“This illustrates that any driver has a risk of being involved in a collision or receiving a citation, and any driver with type 1 diabetes has the additional risk of experiencing disruptive extreme [blood glucose (BG)] that can result in a mishap while driving,” they wrote. “While, ideally, all drivers with type 1 diabetes should measure their BG before driving, they should at least be counseled that, whenever they take more insulin, eat fewer carbohydrates, or engage in more physical activity than usual, they should measure their BG before driving.”
With respect to the impact of the intervention and motivational interviewing, researchers found no significant differences in the rate of mishaps between the groups who received intervention plus interview and those who received the intervention alone, and, as a result, combined these two groups into one.
The high-risk group who underwent the online intervention had fewer driving mishaps than did the high-risk group who received routine care. However, they still had 1.58 times more incidents than did the low-risk individuals who received routine care.
The intervention decreased the risk of mishaps associated with hypoglycemia in high-risk individuals, compared with that in those who recieved routine care, but these individuals still had a higher incidence of hypoglycemia-associated mishaps, compared with the low-risk individuals.
“It is also important to note that [the online intervention] only affected hypoglycemia-related driving mishaps, not hyperglycemia- or nondiabetes-related mishaps,” the authors wrote.
The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
FROM DIABETES CARE
Key clinical point: A scoring questionnaire could help identify drivers with type 1 diabetes at greater risk of driving mishaps and those who could benefit from an intervention to reduce their risk.
Major finding: Individuals with type 1 diabetes who were classified as high-risk according to a scoring system had a more than threefold greater incidence of driving mishaps than those classified as low-risk.
Data source: A two-part study in 1,371 and 1,737 drivers with type 1 diabetes.
Disclosures: The study was funded by the National Institutes of Health and supported in-kind by LifeScan, Abbott Laboratories, MyGlu.com, dLife.com, and Dex4.com.
Earlier childhood measles vaccination elevates the risk of vaccine failure
of age or younger, compared with 15 months of age or older, said Sara Carazo Perez, MD, PhD, of Laval University, Quebec City, and her associates.
Studies suggest that measles elimination “requires the maintenance of population immunity above 92%-94%.” So, “the additional protection of 3%-5% of vaccinated children against secondary vaccine failures by postponing the first dose from 12 to 15 months of age would be significant, and the risk would be minimal in countries that achieved elimination” of measles, said Dr. Perez and her colleagues.
The percentage of children who were seronegative for measles after being vaccinated decreased significantly with older age at the first dose, from 8.5% in children vaccinated at 11 months to 3.2%, 2.4%, and 1.5% with vaccination at 12 months, 13-14 months, and 15-22 months, respectively (P less than .001).
Geometric mean concentrations (GMC) after the second dose were highly correlated with GMCs after the first dose.
The investigators then performed multivariable analysis, adjusting for the type of vaccine, the country, and the study. GMCs rose significantly with older age at first dose. Children vaccinated at 11 months had a 23% lower GMC and 30% increased risk of seronegativity than children vaccinated at 12 months.
In children first vaccinated at 13-14 months or 15-22 months, GMCs were 1.21 and 1.37 times greater than in children vaccinated at 12 months, respectively, and their risks for seronegativity were 49% and 71% lower, respectively.
“After two doses, the association between the age at first dose and the GMC was slightly weaker but still significant,” the researchers said.
Read more in the journal Clinical Infectious Diseases (2017 Jun 8. doi: 10.1093/cid/cix510).
of age or younger, compared with 15 months of age or older, said Sara Carazo Perez, MD, PhD, of Laval University, Quebec City, and her associates.
Studies suggest that measles elimination “requires the maintenance of population immunity above 92%-94%.” So, “the additional protection of 3%-5% of vaccinated children against secondary vaccine failures by postponing the first dose from 12 to 15 months of age would be significant, and the risk would be minimal in countries that achieved elimination” of measles, said Dr. Perez and her colleagues.
The percentage of children who were seronegative for measles after being vaccinated decreased significantly with older age at the first dose, from 8.5% in children vaccinated at 11 months to 3.2%, 2.4%, and 1.5% with vaccination at 12 months, 13-14 months, and 15-22 months, respectively (P less than .001).
Geometric mean concentrations (GMC) after the second dose were highly correlated with GMCs after the first dose.
The investigators then performed multivariable analysis, adjusting for the type of vaccine, the country, and the study. GMCs rose significantly with older age at first dose. Children vaccinated at 11 months had a 23% lower GMC and 30% increased risk of seronegativity than children vaccinated at 12 months.
In children first vaccinated at 13-14 months or 15-22 months, GMCs were 1.21 and 1.37 times greater than in children vaccinated at 12 months, respectively, and their risks for seronegativity were 49% and 71% lower, respectively.
“After two doses, the association between the age at first dose and the GMC was slightly weaker but still significant,” the researchers said.
Read more in the journal Clinical Infectious Diseases (2017 Jun 8. doi: 10.1093/cid/cix510).
of age or younger, compared with 15 months of age or older, said Sara Carazo Perez, MD, PhD, of Laval University, Quebec City, and her associates.
Studies suggest that measles elimination “requires the maintenance of population immunity above 92%-94%.” So, “the additional protection of 3%-5% of vaccinated children against secondary vaccine failures by postponing the first dose from 12 to 15 months of age would be significant, and the risk would be minimal in countries that achieved elimination” of measles, said Dr. Perez and her colleagues.
The percentage of children who were seronegative for measles after being vaccinated decreased significantly with older age at the first dose, from 8.5% in children vaccinated at 11 months to 3.2%, 2.4%, and 1.5% with vaccination at 12 months, 13-14 months, and 15-22 months, respectively (P less than .001).
Geometric mean concentrations (GMC) after the second dose were highly correlated with GMCs after the first dose.
The investigators then performed multivariable analysis, adjusting for the type of vaccine, the country, and the study. GMCs rose significantly with older age at first dose. Children vaccinated at 11 months had a 23% lower GMC and 30% increased risk of seronegativity than children vaccinated at 12 months.
In children first vaccinated at 13-14 months or 15-22 months, GMCs were 1.21 and 1.37 times greater than in children vaccinated at 12 months, respectively, and their risks for seronegativity were 49% and 71% lower, respectively.
“After two doses, the association between the age at first dose and the GMC was slightly weaker but still significant,” the researchers said.
Read more in the journal Clinical Infectious Diseases (2017 Jun 8. doi: 10.1093/cid/cix510).
FROM CLINICAL INFECTIOUS DISEASES