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VIDEO: ‘Meaningless use’? Quality measures pit physicians against patients
NEW YORK – Because quality measures intended to create patient-centered care are impractical, elitist, and ungrounded in the realities of most patients’ lives, physicians are forced to choose between being a failure, a bully, or both.
That’s according to Dr. Richard Young, director of research at the John S. Peters Health System in Fort Worth, Tex., and a speaker at the annual meeting of the North American Primary Care Research Group.
“The grand irony is that patient-centered care ... becomes a carrot-and-stick measurement system that incentivizes [doctors] to get what [they] want patients to do, not what the patients want,” Dr. Young said.
In a video interview, he also explains how borrowing “exception reporting” as practiced in the United Kingdom’s National Health Service would make the United States’ own quality measurement system more practical. Dr. Young also explains how physicians’ fear of missing quality measurement marks may lead them to avoid taking on the sickest and neediest of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
NEW YORK – Because quality measures intended to create patient-centered care are impractical, elitist, and ungrounded in the realities of most patients’ lives, physicians are forced to choose between being a failure, a bully, or both.
That’s according to Dr. Richard Young, director of research at the John S. Peters Health System in Fort Worth, Tex., and a speaker at the annual meeting of the North American Primary Care Research Group.
“The grand irony is that patient-centered care ... becomes a carrot-and-stick measurement system that incentivizes [doctors] to get what [they] want patients to do, not what the patients want,” Dr. Young said.
In a video interview, he also explains how borrowing “exception reporting” as practiced in the United Kingdom’s National Health Service would make the United States’ own quality measurement system more practical. Dr. Young also explains how physicians’ fear of missing quality measurement marks may lead them to avoid taking on the sickest and neediest of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
NEW YORK – Because quality measures intended to create patient-centered care are impractical, elitist, and ungrounded in the realities of most patients’ lives, physicians are forced to choose between being a failure, a bully, or both.
That’s according to Dr. Richard Young, director of research at the John S. Peters Health System in Fort Worth, Tex., and a speaker at the annual meeting of the North American Primary Care Research Group.
“The grand irony is that patient-centered care ... becomes a carrot-and-stick measurement system that incentivizes [doctors] to get what [they] want patients to do, not what the patients want,” Dr. Young said.
In a video interview, he also explains how borrowing “exception reporting” as practiced in the United Kingdom’s National Health Service would make the United States’ own quality measurement system more practical. Dr. Young also explains how physicians’ fear of missing quality measurement marks may lead them to avoid taking on the sickest and neediest of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
AT NAPCRG 2014
Study: FPs with maternity care skills still needed in rural United States
NEW YORK - In rural hospitals, family physicians are very likely to deliver babies, even if the facility has at least one obstetrician with admitting privileges, according to survey results of 457 chief executives of rural American hospitals.
The survey also showed that, in southwestern and western states like Texas and Montana, nearly all maternity care–skilled FPs were likely to perform any necessary C-sections, although, across the country, only 63% of FPs are able to deliver cesarean births, Dr. Richard Young said at the annual meeting of the North American Primary Care Research Group.
Just over two-thirds of the respondents said they had dedicated maternity facilities where, on average, 271 babies are born annually, with just over a quarter being delivered by C-section. The hospital executives reported an average ratio of 1.6 obstetricians to every 2.8 maternity-skilled family practitioners, according to Dr. Young, director of research and associate director of the family medicine residency program at John Peters Smith Hospital in Ft. Worth, Tex., which is affiliated with the University of Texas.
Going by the numbers, the average numbers of vaginal and caesarean births a rural hospital required a family doctor to have performed to receive hospital admitting privileges were 40 and 35, respectively.
Because so many respondents either answered the question loosely or not at all, short of having been fellowship trained, “basically, if you claimed you could do this, then ol’ doc Pritchard would watch you do it, and if he said you were good, then you were good,” he concluded.
Practicing midwives in these hospitals were essentially nonexistent.
The findings point to a need for family practice residency programs to include and, in some cases, expand their maternity medicine offerings. “Rural America needs us,” Dr. Young said.
Other data support his imperative. The American Congress of Obstetricians and Gynecologists reports that nearly half of all 3,107 U.S. counties, many of them in rural areas, lack even one ob.gyn. Meanwhile, a 2013 study published in the Journal of Women’s Health and conducted in part by ACOG indicated that, even by modest measures, in 2020 the demand for maternity care specialists would increase 6%, much of it in states with large rural populations, such as Texas, Nevada, and Idaho, yet the number of ob.gyns. entering the field has remained relatively flat since 1980.
In Dr. Young’s survey, the number of acute-care beds corresponded to the maternity-care workload of the family care physicians. Overall, family physicians who offered maternity care tended to figure most prominently in hospitals with 100 beds or fewer, while facilities with 150 beds or more had double the number of OBs as maternity-skilled FPs; however, even then, two-thirds of the FPs still performed their own C-sections.
The study’s accuracy was limited because not all states were represented in the data, and Dr. Young was unsure if he had been able to reach all rural hospital facilities in each state (his initial mailing was to approximately 1,000 facilities). Of the states where hospital executives did respond, three-quarters of the hospitals were critical-access facilities, 60% were nonprofit centers, and just over a quarter were government run. The rest were either for-profit facilities or other types of centers.
Despite what he said were cultural differences from state to state, Dr. Young said that “family doctors continue to provide the majority of maternity care in rural U.S. hospitals.”
The implications of this, he said, were that, even though it was evident from the low threshold for admitting privileges across the facilities surveyed, family medicine residency programs “know what they need to teach … and we’ve got to keep training these doctors how to do obstetrics, including C-sections, because the OBs aren’t going to go to [rural areas] and do it.”
On Twitter @whitneymcknight
NEW YORK - In rural hospitals, family physicians are very likely to deliver babies, even if the facility has at least one obstetrician with admitting privileges, according to survey results of 457 chief executives of rural American hospitals.
The survey also showed that, in southwestern and western states like Texas and Montana, nearly all maternity care–skilled FPs were likely to perform any necessary C-sections, although, across the country, only 63% of FPs are able to deliver cesarean births, Dr. Richard Young said at the annual meeting of the North American Primary Care Research Group.
Just over two-thirds of the respondents said they had dedicated maternity facilities where, on average, 271 babies are born annually, with just over a quarter being delivered by C-section. The hospital executives reported an average ratio of 1.6 obstetricians to every 2.8 maternity-skilled family practitioners, according to Dr. Young, director of research and associate director of the family medicine residency program at John Peters Smith Hospital in Ft. Worth, Tex., which is affiliated with the University of Texas.
Going by the numbers, the average numbers of vaginal and caesarean births a rural hospital required a family doctor to have performed to receive hospital admitting privileges were 40 and 35, respectively.
Because so many respondents either answered the question loosely or not at all, short of having been fellowship trained, “basically, if you claimed you could do this, then ol’ doc Pritchard would watch you do it, and if he said you were good, then you were good,” he concluded.
Practicing midwives in these hospitals were essentially nonexistent.
The findings point to a need for family practice residency programs to include and, in some cases, expand their maternity medicine offerings. “Rural America needs us,” Dr. Young said.
Other data support his imperative. The American Congress of Obstetricians and Gynecologists reports that nearly half of all 3,107 U.S. counties, many of them in rural areas, lack even one ob.gyn. Meanwhile, a 2013 study published in the Journal of Women’s Health and conducted in part by ACOG indicated that, even by modest measures, in 2020 the demand for maternity care specialists would increase 6%, much of it in states with large rural populations, such as Texas, Nevada, and Idaho, yet the number of ob.gyns. entering the field has remained relatively flat since 1980.
In Dr. Young’s survey, the number of acute-care beds corresponded to the maternity-care workload of the family care physicians. Overall, family physicians who offered maternity care tended to figure most prominently in hospitals with 100 beds or fewer, while facilities with 150 beds or more had double the number of OBs as maternity-skilled FPs; however, even then, two-thirds of the FPs still performed their own C-sections.
The study’s accuracy was limited because not all states were represented in the data, and Dr. Young was unsure if he had been able to reach all rural hospital facilities in each state (his initial mailing was to approximately 1,000 facilities). Of the states where hospital executives did respond, three-quarters of the hospitals were critical-access facilities, 60% were nonprofit centers, and just over a quarter were government run. The rest were either for-profit facilities or other types of centers.
Despite what he said were cultural differences from state to state, Dr. Young said that “family doctors continue to provide the majority of maternity care in rural U.S. hospitals.”
The implications of this, he said, were that, even though it was evident from the low threshold for admitting privileges across the facilities surveyed, family medicine residency programs “know what they need to teach … and we’ve got to keep training these doctors how to do obstetrics, including C-sections, because the OBs aren’t going to go to [rural areas] and do it.”
On Twitter @whitneymcknight
NEW YORK - In rural hospitals, family physicians are very likely to deliver babies, even if the facility has at least one obstetrician with admitting privileges, according to survey results of 457 chief executives of rural American hospitals.
The survey also showed that, in southwestern and western states like Texas and Montana, nearly all maternity care–skilled FPs were likely to perform any necessary C-sections, although, across the country, only 63% of FPs are able to deliver cesarean births, Dr. Richard Young said at the annual meeting of the North American Primary Care Research Group.
Just over two-thirds of the respondents said they had dedicated maternity facilities where, on average, 271 babies are born annually, with just over a quarter being delivered by C-section. The hospital executives reported an average ratio of 1.6 obstetricians to every 2.8 maternity-skilled family practitioners, according to Dr. Young, director of research and associate director of the family medicine residency program at John Peters Smith Hospital in Ft. Worth, Tex., which is affiliated with the University of Texas.
Going by the numbers, the average numbers of vaginal and caesarean births a rural hospital required a family doctor to have performed to receive hospital admitting privileges were 40 and 35, respectively.
Because so many respondents either answered the question loosely or not at all, short of having been fellowship trained, “basically, if you claimed you could do this, then ol’ doc Pritchard would watch you do it, and if he said you were good, then you were good,” he concluded.
Practicing midwives in these hospitals were essentially nonexistent.
The findings point to a need for family practice residency programs to include and, in some cases, expand their maternity medicine offerings. “Rural America needs us,” Dr. Young said.
Other data support his imperative. The American Congress of Obstetricians and Gynecologists reports that nearly half of all 3,107 U.S. counties, many of them in rural areas, lack even one ob.gyn. Meanwhile, a 2013 study published in the Journal of Women’s Health and conducted in part by ACOG indicated that, even by modest measures, in 2020 the demand for maternity care specialists would increase 6%, much of it in states with large rural populations, such as Texas, Nevada, and Idaho, yet the number of ob.gyns. entering the field has remained relatively flat since 1980.
In Dr. Young’s survey, the number of acute-care beds corresponded to the maternity-care workload of the family care physicians. Overall, family physicians who offered maternity care tended to figure most prominently in hospitals with 100 beds or fewer, while facilities with 150 beds or more had double the number of OBs as maternity-skilled FPs; however, even then, two-thirds of the FPs still performed their own C-sections.
The study’s accuracy was limited because not all states were represented in the data, and Dr. Young was unsure if he had been able to reach all rural hospital facilities in each state (his initial mailing was to approximately 1,000 facilities). Of the states where hospital executives did respond, three-quarters of the hospitals were critical-access facilities, 60% were nonprofit centers, and just over a quarter were government run. The rest were either for-profit facilities or other types of centers.
Despite what he said were cultural differences from state to state, Dr. Young said that “family doctors continue to provide the majority of maternity care in rural U.S. hospitals.”
The implications of this, he said, were that, even though it was evident from the low threshold for admitting privileges across the facilities surveyed, family medicine residency programs “know what they need to teach … and we’ve got to keep training these doctors how to do obstetrics, including C-sections, because the OBs aren’t going to go to [rural areas] and do it.”
On Twitter @whitneymcknight
Key clinical point: Family physician residency programs must provide extensive maternity care training.
Major finding: Family physicians are twice as likely, on average, to deliver babies in the rural United States, compared with OBs; two-thirds of these FPs perform C-sections.
Data source: Survey of 457 rural American hospital CEOs.
Disclosures: Neither Dr. Young nor his associate, Dr. Kelsey Walker, had any relevant disclosures. The study was made possible by a grant from the Texas Academy of Family Physicians.
Immunosuppression not tied to subsequent cancer in IBD with cancer history
ORLANDO – Immunosuppressive therapies were not associated with subsequent cancers in patients with inflammatory bowel disease who also had a history of cancer, a retrospective analysis showed.
In a review of 185 patient records from three sites chosen according to whether the person had both a history of cancer and a confirmed diagnosis of inflammatory bowel disease (IBD), patients had at least one follow-up visit after their respective cancer diagnosis.
There were three study arms: 65 patients who’d been treated for their IBD with anti–TNF-alpha immunosuppression, 46 patients who’d received antimetabolite immunosuppressive treatment, and 74 controls who’d not been exposed to immunosuppression. The primary outcome was the development of incident cancer, whether new or recurrent, as calculated from the date of the initial cancer diagnosis to the date of the recurrent or new malignancy or to the date of the patient’s last clinical visit.
Nearly a third of all patients developed incident cancer during the follow-up period, but there were not any statistically significant differences in incident rates between groups, Dr. Jordan Axelrad reported at a conference on inflammatory bowel diseases, sponsored by the Crohn’s & Colitis Foundation of America.
Just over 14% of all patients developed a new cancer, 12% developed a recurrent cancer, and slightly less than 3% developed both a new and recurrent cancer.
“There were qualitatively more skin cancers in the anti–TNF[-alpha] group, and more GI cancers in the control group,” said Dr. Axelrad of Mt. Sinai Hospital in New York.
Solid cancers occurred primarily in the control and antimetabolite groups, 46.4% and 46.2%, respectively. Hematologic cancers were least common, with none in the control group and one each in the study arms.
In addition, Dr. Axelrad said that at 5 years post follow-up, there was no significant difference in cancer-free survival rates between the three groups (P = .086).
Because the study was limited by a lack of data on any dose-related effects or periods of cancer remission, as well as the population size, Dr. Axelrad said he hoped a consortium effort by the New York Crohn’s and Colitis Organization, which includes Mt. Sinai, would help collect sufficient data to make future, higher-powered studies possible.
Dr. Axelrad said he had no relevant financial disclosures.
On Twitter @whitneymcknight
ORLANDO – Immunosuppressive therapies were not associated with subsequent cancers in patients with inflammatory bowel disease who also had a history of cancer, a retrospective analysis showed.
In a review of 185 patient records from three sites chosen according to whether the person had both a history of cancer and a confirmed diagnosis of inflammatory bowel disease (IBD), patients had at least one follow-up visit after their respective cancer diagnosis.
There were three study arms: 65 patients who’d been treated for their IBD with anti–TNF-alpha immunosuppression, 46 patients who’d received antimetabolite immunosuppressive treatment, and 74 controls who’d not been exposed to immunosuppression. The primary outcome was the development of incident cancer, whether new or recurrent, as calculated from the date of the initial cancer diagnosis to the date of the recurrent or new malignancy or to the date of the patient’s last clinical visit.
Nearly a third of all patients developed incident cancer during the follow-up period, but there were not any statistically significant differences in incident rates between groups, Dr. Jordan Axelrad reported at a conference on inflammatory bowel diseases, sponsored by the Crohn’s & Colitis Foundation of America.
Just over 14% of all patients developed a new cancer, 12% developed a recurrent cancer, and slightly less than 3% developed both a new and recurrent cancer.
“There were qualitatively more skin cancers in the anti–TNF[-alpha] group, and more GI cancers in the control group,” said Dr. Axelrad of Mt. Sinai Hospital in New York.
Solid cancers occurred primarily in the control and antimetabolite groups, 46.4% and 46.2%, respectively. Hematologic cancers were least common, with none in the control group and one each in the study arms.
In addition, Dr. Axelrad said that at 5 years post follow-up, there was no significant difference in cancer-free survival rates between the three groups (P = .086).
Because the study was limited by a lack of data on any dose-related effects or periods of cancer remission, as well as the population size, Dr. Axelrad said he hoped a consortium effort by the New York Crohn’s and Colitis Organization, which includes Mt. Sinai, would help collect sufficient data to make future, higher-powered studies possible.
Dr. Axelrad said he had no relevant financial disclosures.
On Twitter @whitneymcknight
ORLANDO – Immunosuppressive therapies were not associated with subsequent cancers in patients with inflammatory bowel disease who also had a history of cancer, a retrospective analysis showed.
In a review of 185 patient records from three sites chosen according to whether the person had both a history of cancer and a confirmed diagnosis of inflammatory bowel disease (IBD), patients had at least one follow-up visit after their respective cancer diagnosis.
There were three study arms: 65 patients who’d been treated for their IBD with anti–TNF-alpha immunosuppression, 46 patients who’d received antimetabolite immunosuppressive treatment, and 74 controls who’d not been exposed to immunosuppression. The primary outcome was the development of incident cancer, whether new or recurrent, as calculated from the date of the initial cancer diagnosis to the date of the recurrent or new malignancy or to the date of the patient’s last clinical visit.
Nearly a third of all patients developed incident cancer during the follow-up period, but there were not any statistically significant differences in incident rates between groups, Dr. Jordan Axelrad reported at a conference on inflammatory bowel diseases, sponsored by the Crohn’s & Colitis Foundation of America.
Just over 14% of all patients developed a new cancer, 12% developed a recurrent cancer, and slightly less than 3% developed both a new and recurrent cancer.
“There were qualitatively more skin cancers in the anti–TNF[-alpha] group, and more GI cancers in the control group,” said Dr. Axelrad of Mt. Sinai Hospital in New York.
Solid cancers occurred primarily in the control and antimetabolite groups, 46.4% and 46.2%, respectively. Hematologic cancers were least common, with none in the control group and one each in the study arms.
In addition, Dr. Axelrad said that at 5 years post follow-up, there was no significant difference in cancer-free survival rates between the three groups (P = .086).
Because the study was limited by a lack of data on any dose-related effects or periods of cancer remission, as well as the population size, Dr. Axelrad said he hoped a consortium effort by the New York Crohn’s and Colitis Organization, which includes Mt. Sinai, would help collect sufficient data to make future, higher-powered studies possible.
Dr. Axelrad said he had no relevant financial disclosures.
On Twitter @whitneymcknight
AT 2014 ADVANCES IN IBD
Key clinical point: Immunosuppressive therapy in IBD patients is not related to cancer in patients with a history of cancer.
Major finding: There were no statistical differences between IBD patients exposed to various forms of immunosuppression and controls.
Data source: A multisite retrospective analysis of 185 records from patients with IBD and cancer and at least one follow-up postcancer diagnosis.
Disclosures: Dr. Axelrad said he had no relevant financial disclosures.
Lose the weight or lose the money: Online weight-loss contracts gain favor
NEW YORK – The more you stand to lose, the deeper your commitment to losing, particularly when it’s your wallet and not your word that’s at stake.
People who contractually committed online to lose a certain amount of weight or else fork over a predetermined amount of cash to a friend, a favorite charity, or even a hated charity were, on average, successful at losing 5.2% of their body weight, according to preliminary data presented at the annual meeting of the North American Primary Care Research Group.
In a retrospective analysis of 5,024 self-selected participants in an online contractual weight loss site, 70% of whom were women whose average age was 39 years, the ones who pledged to let their money go to an “anticharity” if they didn’t meet their weight loss goals lost nearly 8% of their body weight. Those who pledged to give to a favorite charity lost just under 7%, and those who promised to pay a friend if they didn’t succeed lost 6.3% of their body weight. Those whose commitment did not involve any cash lost 3.4% of their body weight.
“If you are for gun control, your anticharity would be the National Rifle Association,” Dr. Lenard Lesser, a family physician and researcher at the Palo Alto (Calif.) Medical Foundation and Research Institute, said in an interview. “So, if you don’t lose the weight you said you’d lose, then the money you committed would go to the NRA.”
There was no statistical difference in weight loss between those who committed to either a charity or an anticharity, but according to Dr. Lesser, the data, set to be published in the near future, indicated that there was a statistical difference between the amount of weight lost when money was committed compared with when no money was committed. “People are averse to losing money wherever it goes,” he said.
The average duration of the weight loss commitments in the online weight loss commitment study were between 10 and 16 weeks, but it is unclear whether the weight loss was permanent, and whether the contracts could serve as a viable weight loss intervention in the primary care setting, according to Dr. Lesser. “We don’t know what happens to these people long term. We need to explore how these contracts can be integrated into a more comprehensive system.”
On Twitter @whitneymcknight
NEW YORK – The more you stand to lose, the deeper your commitment to losing, particularly when it’s your wallet and not your word that’s at stake.
People who contractually committed online to lose a certain amount of weight or else fork over a predetermined amount of cash to a friend, a favorite charity, or even a hated charity were, on average, successful at losing 5.2% of their body weight, according to preliminary data presented at the annual meeting of the North American Primary Care Research Group.
In a retrospective analysis of 5,024 self-selected participants in an online contractual weight loss site, 70% of whom were women whose average age was 39 years, the ones who pledged to let their money go to an “anticharity” if they didn’t meet their weight loss goals lost nearly 8% of their body weight. Those who pledged to give to a favorite charity lost just under 7%, and those who promised to pay a friend if they didn’t succeed lost 6.3% of their body weight. Those whose commitment did not involve any cash lost 3.4% of their body weight.
“If you are for gun control, your anticharity would be the National Rifle Association,” Dr. Lenard Lesser, a family physician and researcher at the Palo Alto (Calif.) Medical Foundation and Research Institute, said in an interview. “So, if you don’t lose the weight you said you’d lose, then the money you committed would go to the NRA.”
There was no statistical difference in weight loss between those who committed to either a charity or an anticharity, but according to Dr. Lesser, the data, set to be published in the near future, indicated that there was a statistical difference between the amount of weight lost when money was committed compared with when no money was committed. “People are averse to losing money wherever it goes,” he said.
The average duration of the weight loss commitments in the online weight loss commitment study were between 10 and 16 weeks, but it is unclear whether the weight loss was permanent, and whether the contracts could serve as a viable weight loss intervention in the primary care setting, according to Dr. Lesser. “We don’t know what happens to these people long term. We need to explore how these contracts can be integrated into a more comprehensive system.”
On Twitter @whitneymcknight
NEW YORK – The more you stand to lose, the deeper your commitment to losing, particularly when it’s your wallet and not your word that’s at stake.
People who contractually committed online to lose a certain amount of weight or else fork over a predetermined amount of cash to a friend, a favorite charity, or even a hated charity were, on average, successful at losing 5.2% of their body weight, according to preliminary data presented at the annual meeting of the North American Primary Care Research Group.
In a retrospective analysis of 5,024 self-selected participants in an online contractual weight loss site, 70% of whom were women whose average age was 39 years, the ones who pledged to let their money go to an “anticharity” if they didn’t meet their weight loss goals lost nearly 8% of their body weight. Those who pledged to give to a favorite charity lost just under 7%, and those who promised to pay a friend if they didn’t succeed lost 6.3% of their body weight. Those whose commitment did not involve any cash lost 3.4% of their body weight.
“If you are for gun control, your anticharity would be the National Rifle Association,” Dr. Lenard Lesser, a family physician and researcher at the Palo Alto (Calif.) Medical Foundation and Research Institute, said in an interview. “So, if you don’t lose the weight you said you’d lose, then the money you committed would go to the NRA.”
There was no statistical difference in weight loss between those who committed to either a charity or an anticharity, but according to Dr. Lesser, the data, set to be published in the near future, indicated that there was a statistical difference between the amount of weight lost when money was committed compared with when no money was committed. “People are averse to losing money wherever it goes,” he said.
The average duration of the weight loss commitments in the online weight loss commitment study were between 10 and 16 weeks, but it is unclear whether the weight loss was permanent, and whether the contracts could serve as a viable weight loss intervention in the primary care setting, according to Dr. Lesser. “We don’t know what happens to these people long term. We need to explore how these contracts can be integrated into a more comprehensive system.”
On Twitter @whitneymcknight
AT NAPCRG 2014
Key clinical point: Online weight-loss commitment contracts can be effective interventions for patients.
Major finding: People who contractually committed to losing weight lost an average of 5.2% of their body weight; when loss of money was at stake, the body weight losses were highest.
Data source: A retrospective secondary analysis of online commitment contracts from 5,024 self-selected individuals.
Disclosures: Dr. Lesser said he did not have any relevant disclosures.
Less confident nurses more likely to elevate triage level in calls to primary care clinics
NEW YORK – Nurses who lacked confidence as telephone triage advisers were more likely than more confident nurses to elevate the triage level of patients calling general practice clinics for same-day service, according to a British report.
The findings have implications for busy general practice physicians who are considering such programs to help ease their daily patient load.
Although there is “broad public support” in Britain for nurse practitioners and general nursing staff taking on many of the tasks usually associated with general practitioners, the manner in which these nurses handle patients varies greatly, according to Anna Varley, a social worker and researcher at the University of East Anglia, Norwich, England, who spoke at the annual meeting of the North American Primary Care Research Group.
“Previous research is still equivocal as to explaining exactly why it is that different health professionals make different decisions about the same calls,” Ms. Varley said to a capacity crowd.
However, data from a randomized, controlled study of telephone triage services indicated that a nurse’s self-reported level of preparedness, was key to how – and if – she advised that callers receive follow-up care.
“Therefore, standardized telephone triage training is necessary, but it may not be sufficient,” Ms. Varley said.
The data were part of the larger, clustered, randomized controlled ESTEEM trial conducted across four regions in the United Kingdom between March 2011 and March 2013 to examine the outcomes and cost-effectiveness of telephone triage services. In the study, patients seeking same-day consultations were randomly assigned with intention to treat and by protocol, to either general practice–led phone triage care; nurse practitioner–led, computer-supported phone triage care; or usual practice. Allocation was not blinded to patients, clinicians, or researchers, but practice assignment was concealed from the study’s statistician. In all, 20,990 patient calls were managed by 42 general care clinics, with 77% of all patient-clinician interactions reaching the primary outcome of additional follow-up within 28 days of the initial call. The results of the larger trial were published recently in the Lancet (2014 Nov. 22 [doi:10.1016/S0140-6736(14)61058-8]). For the subanalysis, Ms. Varley and her coinvestigators evaluated the 7,012 patient calls randomly routed to triage intervention from 45 nurses across 15 general practices in the four regions. All of the nursing staff were women, and all had been trained in the use of the clinical decision support software. All nurses were surveyed to discover their levels of training, experience, and facility with triage software. Thirty-five of the original 45 nurses returned valid profiles.
Of these, eight were nurse practitioners, an important distinction given that in the United Kingdom, this denotes more years of formal medical training than other nursing professionals, the authority to diagnose, and typically, the authority to prescribe medication.
The remaining 27 nurses were what are known in Britain as “practice nurses.” This group is not authorized to prescribe, and generally has less authority in other matters as well.
The range of the two groups of nurses’ years of experience was 2.5-40 years, although 89% of all nurse participants had 10 or more years of practical experience; 69% had 20 or more years of experience.
Across both groups, nearly half had prior experience manning triage phone lines, although only 2 of the 35 women had ever used the clinical support software.
At the time of each call, the nurses were asked to rate how prepared they felt for the particulars of the call. These data were included when evaluating how often each nurse recommended a caller for follow-up. Although most calls (86%) were recommended to some form of follow-up, nurse practitioners were less likely than practice nurses to recommend follow-up care (odds ratio, 0.19; confidence interval, 0.07-0.49). Across both groups, nurses who reported less confidence in their ability to manage the call were found more likely to recommend patients for follow-up (OR, 3.17; CI, 1.18-5.55). Additionally, less seasoned nurses, defined as those with 10 or less years of practical experience, had significantly longer mean call durations (OR, 2.58; CI, 0.76-4.40).
As reported in the larger ESTEEM trial, nurse-led triage resulted in an overall 48% increase in patient contacts over a 28-day period, compared with usual care. General practice physician–led triage resulted in a 33% increase over usual care during the same period. Despite the increase in patient contacts, the costs of care were found to remain essentially the same (about 75 British pounds sterling). Eight deaths were reported overall, including two triaged by the nurses, but none of the deaths were associated with the trial itself.
The overall implications of the study are positive, so long as there is already an established trust between the patient and the general practice clinic, according to Dr. Garey Mazowita, a family practice physician in Vancouver, B.C., who is participating in a telephone screening program for general practitioners in his home province.
“At the heart of the medical home model we are moving toward is the continuity of the relationship between the family care doctor and the patient, and the knowledge that if you do something over the phone that averts an office visit, you’ve still got the security of the relationship [to rely on],” Dr. Mazowita, who is also the president of the College of Family Physicians of Canada, said in an interview. “We think it’s fundamentally safer than if no relationship exists.”
Ms. Varley agreed that how general practice clinics, and in particular, the physicians, related to patients overall was important, but said that for the purpose of nurse-led call screening, it was important to note that while all triage call screening was shown in the study to be comparably safe, “the individual characteristics of nurses independently influenced how telephone triage was implemented.”
Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.
On Twitter @whitneymcknight
NEW YORK – Nurses who lacked confidence as telephone triage advisers were more likely than more confident nurses to elevate the triage level of patients calling general practice clinics for same-day service, according to a British report.
The findings have implications for busy general practice physicians who are considering such programs to help ease their daily patient load.
Although there is “broad public support” in Britain for nurse practitioners and general nursing staff taking on many of the tasks usually associated with general practitioners, the manner in which these nurses handle patients varies greatly, according to Anna Varley, a social worker and researcher at the University of East Anglia, Norwich, England, who spoke at the annual meeting of the North American Primary Care Research Group.
“Previous research is still equivocal as to explaining exactly why it is that different health professionals make different decisions about the same calls,” Ms. Varley said to a capacity crowd.
However, data from a randomized, controlled study of telephone triage services indicated that a nurse’s self-reported level of preparedness, was key to how – and if – she advised that callers receive follow-up care.
“Therefore, standardized telephone triage training is necessary, but it may not be sufficient,” Ms. Varley said.
The data were part of the larger, clustered, randomized controlled ESTEEM trial conducted across four regions in the United Kingdom between March 2011 and March 2013 to examine the outcomes and cost-effectiveness of telephone triage services. In the study, patients seeking same-day consultations were randomly assigned with intention to treat and by protocol, to either general practice–led phone triage care; nurse practitioner–led, computer-supported phone triage care; or usual practice. Allocation was not blinded to patients, clinicians, or researchers, but practice assignment was concealed from the study’s statistician. In all, 20,990 patient calls were managed by 42 general care clinics, with 77% of all patient-clinician interactions reaching the primary outcome of additional follow-up within 28 days of the initial call. The results of the larger trial were published recently in the Lancet (2014 Nov. 22 [doi:10.1016/S0140-6736(14)61058-8]). For the subanalysis, Ms. Varley and her coinvestigators evaluated the 7,012 patient calls randomly routed to triage intervention from 45 nurses across 15 general practices in the four regions. All of the nursing staff were women, and all had been trained in the use of the clinical decision support software. All nurses were surveyed to discover their levels of training, experience, and facility with triage software. Thirty-five of the original 45 nurses returned valid profiles.
Of these, eight were nurse practitioners, an important distinction given that in the United Kingdom, this denotes more years of formal medical training than other nursing professionals, the authority to diagnose, and typically, the authority to prescribe medication.
The remaining 27 nurses were what are known in Britain as “practice nurses.” This group is not authorized to prescribe, and generally has less authority in other matters as well.
The range of the two groups of nurses’ years of experience was 2.5-40 years, although 89% of all nurse participants had 10 or more years of practical experience; 69% had 20 or more years of experience.
Across both groups, nearly half had prior experience manning triage phone lines, although only 2 of the 35 women had ever used the clinical support software.
At the time of each call, the nurses were asked to rate how prepared they felt for the particulars of the call. These data were included when evaluating how often each nurse recommended a caller for follow-up. Although most calls (86%) were recommended to some form of follow-up, nurse practitioners were less likely than practice nurses to recommend follow-up care (odds ratio, 0.19; confidence interval, 0.07-0.49). Across both groups, nurses who reported less confidence in their ability to manage the call were found more likely to recommend patients for follow-up (OR, 3.17; CI, 1.18-5.55). Additionally, less seasoned nurses, defined as those with 10 or less years of practical experience, had significantly longer mean call durations (OR, 2.58; CI, 0.76-4.40).
As reported in the larger ESTEEM trial, nurse-led triage resulted in an overall 48% increase in patient contacts over a 28-day period, compared with usual care. General practice physician–led triage resulted in a 33% increase over usual care during the same period. Despite the increase in patient contacts, the costs of care were found to remain essentially the same (about 75 British pounds sterling). Eight deaths were reported overall, including two triaged by the nurses, but none of the deaths were associated with the trial itself.
The overall implications of the study are positive, so long as there is already an established trust between the patient and the general practice clinic, according to Dr. Garey Mazowita, a family practice physician in Vancouver, B.C., who is participating in a telephone screening program for general practitioners in his home province.
“At the heart of the medical home model we are moving toward is the continuity of the relationship between the family care doctor and the patient, and the knowledge that if you do something over the phone that averts an office visit, you’ve still got the security of the relationship [to rely on],” Dr. Mazowita, who is also the president of the College of Family Physicians of Canada, said in an interview. “We think it’s fundamentally safer than if no relationship exists.”
Ms. Varley agreed that how general practice clinics, and in particular, the physicians, related to patients overall was important, but said that for the purpose of nurse-led call screening, it was important to note that while all triage call screening was shown in the study to be comparably safe, “the individual characteristics of nurses independently influenced how telephone triage was implemented.”
Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.
On Twitter @whitneymcknight
NEW YORK – Nurses who lacked confidence as telephone triage advisers were more likely than more confident nurses to elevate the triage level of patients calling general practice clinics for same-day service, according to a British report.
The findings have implications for busy general practice physicians who are considering such programs to help ease their daily patient load.
Although there is “broad public support” in Britain for nurse practitioners and general nursing staff taking on many of the tasks usually associated with general practitioners, the manner in which these nurses handle patients varies greatly, according to Anna Varley, a social worker and researcher at the University of East Anglia, Norwich, England, who spoke at the annual meeting of the North American Primary Care Research Group.
“Previous research is still equivocal as to explaining exactly why it is that different health professionals make different decisions about the same calls,” Ms. Varley said to a capacity crowd.
However, data from a randomized, controlled study of telephone triage services indicated that a nurse’s self-reported level of preparedness, was key to how – and if – she advised that callers receive follow-up care.
“Therefore, standardized telephone triage training is necessary, but it may not be sufficient,” Ms. Varley said.
The data were part of the larger, clustered, randomized controlled ESTEEM trial conducted across four regions in the United Kingdom between March 2011 and March 2013 to examine the outcomes and cost-effectiveness of telephone triage services. In the study, patients seeking same-day consultations were randomly assigned with intention to treat and by protocol, to either general practice–led phone triage care; nurse practitioner–led, computer-supported phone triage care; or usual practice. Allocation was not blinded to patients, clinicians, or researchers, but practice assignment was concealed from the study’s statistician. In all, 20,990 patient calls were managed by 42 general care clinics, with 77% of all patient-clinician interactions reaching the primary outcome of additional follow-up within 28 days of the initial call. The results of the larger trial were published recently in the Lancet (2014 Nov. 22 [doi:10.1016/S0140-6736(14)61058-8]). For the subanalysis, Ms. Varley and her coinvestigators evaluated the 7,012 patient calls randomly routed to triage intervention from 45 nurses across 15 general practices in the four regions. All of the nursing staff were women, and all had been trained in the use of the clinical decision support software. All nurses were surveyed to discover their levels of training, experience, and facility with triage software. Thirty-five of the original 45 nurses returned valid profiles.
Of these, eight were nurse practitioners, an important distinction given that in the United Kingdom, this denotes more years of formal medical training than other nursing professionals, the authority to diagnose, and typically, the authority to prescribe medication.
The remaining 27 nurses were what are known in Britain as “practice nurses.” This group is not authorized to prescribe, and generally has less authority in other matters as well.
The range of the two groups of nurses’ years of experience was 2.5-40 years, although 89% of all nurse participants had 10 or more years of practical experience; 69% had 20 or more years of experience.
Across both groups, nearly half had prior experience manning triage phone lines, although only 2 of the 35 women had ever used the clinical support software.
At the time of each call, the nurses were asked to rate how prepared they felt for the particulars of the call. These data were included when evaluating how often each nurse recommended a caller for follow-up. Although most calls (86%) were recommended to some form of follow-up, nurse practitioners were less likely than practice nurses to recommend follow-up care (odds ratio, 0.19; confidence interval, 0.07-0.49). Across both groups, nurses who reported less confidence in their ability to manage the call were found more likely to recommend patients for follow-up (OR, 3.17; CI, 1.18-5.55). Additionally, less seasoned nurses, defined as those with 10 or less years of practical experience, had significantly longer mean call durations (OR, 2.58; CI, 0.76-4.40).
As reported in the larger ESTEEM trial, nurse-led triage resulted in an overall 48% increase in patient contacts over a 28-day period, compared with usual care. General practice physician–led triage resulted in a 33% increase over usual care during the same period. Despite the increase in patient contacts, the costs of care were found to remain essentially the same (about 75 British pounds sterling). Eight deaths were reported overall, including two triaged by the nurses, but none of the deaths were associated with the trial itself.
The overall implications of the study are positive, so long as there is already an established trust between the patient and the general practice clinic, according to Dr. Garey Mazowita, a family practice physician in Vancouver, B.C., who is participating in a telephone screening program for general practitioners in his home province.
“At the heart of the medical home model we are moving toward is the continuity of the relationship between the family care doctor and the patient, and the knowledge that if you do something over the phone that averts an office visit, you’ve still got the security of the relationship [to rely on],” Dr. Mazowita, who is also the president of the College of Family Physicians of Canada, said in an interview. “We think it’s fundamentally safer than if no relationship exists.”
Ms. Varley agreed that how general practice clinics, and in particular, the physicians, related to patients overall was important, but said that for the purpose of nurse-led call screening, it was important to note that while all triage call screening was shown in the study to be comparably safe, “the individual characteristics of nurses independently influenced how telephone triage was implemented.”
Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.
On Twitter @whitneymcknight
AT NAPCRG 2014
Key clinical point: Telephone triage training may not be enough to help nursing staff adequately manage callers seeking same-day consultations from general practice physicians.
Major finding: Nurses with more advanced medical training and higher levels of self-reported confidence about triage calls were less likely to recommend follow-up, compared with nurses with fewer years of formal education and less confidence in their skills (OR, 0.19, 3.17 respectively).
Data source: Telephone triage data from a randomized, controlled trial of 7,012 patient calls managed by 45 nurses across 15 general practice clinics in the United Kingdom.
Disclosures: Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.
New use for old DXA scanners?
NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.
Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.
Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.
“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”
BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m2 instead of 27.8 kg/m2.
“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.
Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.
“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”
Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).
“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.
The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.
DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.
Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.
Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.
“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.
“We have the equipment, it’s just a matter of updating the software,” he said.
Dr. Goldstein said he had no relevant disclosures.
On Twitter @whitneymcknight
Body mass index is the best screening tool we have to identify and stage the disease of obesity. Like other diseases, there are additional prognostic factors that influence disease severity. Additional information regarding fat composition can indicate more risk in addition to BMI. For example, more visceral or abdominal fat could imply greater cardiac risk particularly in Asian populations. BMI is the fifth vital sign, and any BMI >30 warrants discussion regarding treatment. Additional studies like DXA scans can elaborate additional risk that can be mitigated through safe and effective treatments for obesity like bariatric surgery.
John Morton, M.D., is chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. He was asked to comment on this study.
Body mass index is the best screening tool we have to identify and stage the disease of obesity. Like other diseases, there are additional prognostic factors that influence disease severity. Additional information regarding fat composition can indicate more risk in addition to BMI. For example, more visceral or abdominal fat could imply greater cardiac risk particularly in Asian populations. BMI is the fifth vital sign, and any BMI >30 warrants discussion regarding treatment. Additional studies like DXA scans can elaborate additional risk that can be mitigated through safe and effective treatments for obesity like bariatric surgery.
John Morton, M.D., is chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. He was asked to comment on this study.
Body mass index is the best screening tool we have to identify and stage the disease of obesity. Like other diseases, there are additional prognostic factors that influence disease severity. Additional information regarding fat composition can indicate more risk in addition to BMI. For example, more visceral or abdominal fat could imply greater cardiac risk particularly in Asian populations. BMI is the fifth vital sign, and any BMI >30 warrants discussion regarding treatment. Additional studies like DXA scans can elaborate additional risk that can be mitigated through safe and effective treatments for obesity like bariatric surgery.
John Morton, M.D., is chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. He was asked to comment on this study.
NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.
Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.
Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.
“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”
BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m2 instead of 27.8 kg/m2.
“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.
Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.
“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”
Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).
“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.
The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.
DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.
Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.
Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.
“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.
“We have the equipment, it’s just a matter of updating the software,” he said.
Dr. Goldstein said he had no relevant disclosures.
On Twitter @whitneymcknight
NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.
Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.
Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.
“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”
BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m2 instead of 27.8 kg/m2.
“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.
Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.
“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”
Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).
“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.
The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.
DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.
Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.
Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.
“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.
“We have the equipment, it’s just a matter of updating the software,” he said.
Dr. Goldstein said he had no relevant disclosures.
On Twitter @whitneymcknight
AT THE 2014 NAMS MEETING
Key clinical point: Dual energy X-ray absorptiometry (DXA) data may be better than BMI for assessing metabolic health in postmenopausal women, bariatric surgery candidates.
Major finding: Approximately 20% of postmenopausal women were possibly misdiagnosed as metabolically healthy when BMI was only measurement used.
Data source: Pilot study of 50 consecutive postmenopausal women given DXA scan at a single site.
Disclosures: Dr. Goldstein said he had no relevant disclosures.
Patient-centered medical homes bested others in chronic pain management
NEW YORK– Certified patient-centered medical homes were significantly more likely to adhere to pain management guidelines than were uncredentialed primary care practices, a retrospective study has shown.
Because patient-centered medical homes are predicated on safety and quality, coordination and integration, Dr. Nancy C. Elder, professor and director of research in the department of family and community medicine at the University of Cincinnati, said that they were already focused on primary care pain process guidelines for managing musculoskeletal pain established in 2011.
“A team, multidisciplinary approach to care, typical of a medical home, is generally associated with better pain outcomes,” Dr. Elder told a standing-room only crowd at the chronic pain research track of the annual meeting of the North American Primary Care Research Group.
Still, there are few data to support a direct correlation between patient-centered medical home (PCMH) protocols as defined by the National Committee for Quality Assurance and how chronic pain is managed.
To address that gap, Dr. Elder and her associates conducted a random review of 485 charts of chronic pain patients seen at least twice at one of 12 academic-affiliated primary care practices in a 12-month period. Three of the practices had achieved PCMH certification in 2010, five were certified in 2013 prior to the study, and four clinics had no medical home certification. There was one internal medicine residency, while the rest were a combination of either family and internal medicine or internal medicine and pediatrics practices. Between 6 to 15 charts were reviewed per provider, although per office the range was between 10 and 95 charts. Charts from experienced PCMH clinics numbered 128, while newer PCMH-certified-clinic charts numbered 242. There were 115 non–PCMH clinic chart reviews.
Patients across all three clinic groups ranged in age from 56 years to 61.6 years and were predominantly white women.
The non-PCMH offices, when compared with the certified clinics, were significantly less likely to document four of eight key data points to assess and manage chronic pain, including a patient’s pain severity (39% vs. 75%, P less than .001), functional disability (41% vs. 66%, P less than .001), psychosocial distress (38% vs. 54%, P = .01), or substance abuse (13% vs. 32%, P less than .001).
All clinics were inclined to address depression and employ nonpharmacologic approaches to pain, although opioids were prescribed chronically 57% of the time, regardless of PCMH certification status. All clinics were equally likely to ask patients to enter into an opioid-use contract, but noncertified practices were less likely to assess patients for the side effects of opioid use (56% vs. 68%, P = .02), perform a urine drug screen (27% vs. 48%), or review a state controlled-prescription report (38% vs. 50%, P = .005).
Although Dr. Elder concluded that the medical home model is conducive to better chronic pain management, the actual relationship between protocols and patient outcomes is still unknown. She also noted that, although there was not a statistically significant difference, practices that had been PCMH certified the longest did not perform as well as the practices with newer certification.
“That raised the question about whether some of the skills and benefits of becoming a PCMH wane with time,” she said.
Dr. Elder did not state any relevant disclosures.
On Twitter @whitneymcknight
NEW YORK– Certified patient-centered medical homes were significantly more likely to adhere to pain management guidelines than were uncredentialed primary care practices, a retrospective study has shown.
Because patient-centered medical homes are predicated on safety and quality, coordination and integration, Dr. Nancy C. Elder, professor and director of research in the department of family and community medicine at the University of Cincinnati, said that they were already focused on primary care pain process guidelines for managing musculoskeletal pain established in 2011.
“A team, multidisciplinary approach to care, typical of a medical home, is generally associated with better pain outcomes,” Dr. Elder told a standing-room only crowd at the chronic pain research track of the annual meeting of the North American Primary Care Research Group.
Still, there are few data to support a direct correlation between patient-centered medical home (PCMH) protocols as defined by the National Committee for Quality Assurance and how chronic pain is managed.
To address that gap, Dr. Elder and her associates conducted a random review of 485 charts of chronic pain patients seen at least twice at one of 12 academic-affiliated primary care practices in a 12-month period. Three of the practices had achieved PCMH certification in 2010, five were certified in 2013 prior to the study, and four clinics had no medical home certification. There was one internal medicine residency, while the rest were a combination of either family and internal medicine or internal medicine and pediatrics practices. Between 6 to 15 charts were reviewed per provider, although per office the range was between 10 and 95 charts. Charts from experienced PCMH clinics numbered 128, while newer PCMH-certified-clinic charts numbered 242. There were 115 non–PCMH clinic chart reviews.
Patients across all three clinic groups ranged in age from 56 years to 61.6 years and were predominantly white women.
The non-PCMH offices, when compared with the certified clinics, were significantly less likely to document four of eight key data points to assess and manage chronic pain, including a patient’s pain severity (39% vs. 75%, P less than .001), functional disability (41% vs. 66%, P less than .001), psychosocial distress (38% vs. 54%, P = .01), or substance abuse (13% vs. 32%, P less than .001).
All clinics were inclined to address depression and employ nonpharmacologic approaches to pain, although opioids were prescribed chronically 57% of the time, regardless of PCMH certification status. All clinics were equally likely to ask patients to enter into an opioid-use contract, but noncertified practices were less likely to assess patients for the side effects of opioid use (56% vs. 68%, P = .02), perform a urine drug screen (27% vs. 48%), or review a state controlled-prescription report (38% vs. 50%, P = .005).
Although Dr. Elder concluded that the medical home model is conducive to better chronic pain management, the actual relationship between protocols and patient outcomes is still unknown. She also noted that, although there was not a statistically significant difference, practices that had been PCMH certified the longest did not perform as well as the practices with newer certification.
“That raised the question about whether some of the skills and benefits of becoming a PCMH wane with time,” she said.
Dr. Elder did not state any relevant disclosures.
On Twitter @whitneymcknight
NEW YORK– Certified patient-centered medical homes were significantly more likely to adhere to pain management guidelines than were uncredentialed primary care practices, a retrospective study has shown.
Because patient-centered medical homes are predicated on safety and quality, coordination and integration, Dr. Nancy C. Elder, professor and director of research in the department of family and community medicine at the University of Cincinnati, said that they were already focused on primary care pain process guidelines for managing musculoskeletal pain established in 2011.
“A team, multidisciplinary approach to care, typical of a medical home, is generally associated with better pain outcomes,” Dr. Elder told a standing-room only crowd at the chronic pain research track of the annual meeting of the North American Primary Care Research Group.
Still, there are few data to support a direct correlation between patient-centered medical home (PCMH) protocols as defined by the National Committee for Quality Assurance and how chronic pain is managed.
To address that gap, Dr. Elder and her associates conducted a random review of 485 charts of chronic pain patients seen at least twice at one of 12 academic-affiliated primary care practices in a 12-month period. Three of the practices had achieved PCMH certification in 2010, five were certified in 2013 prior to the study, and four clinics had no medical home certification. There was one internal medicine residency, while the rest were a combination of either family and internal medicine or internal medicine and pediatrics practices. Between 6 to 15 charts were reviewed per provider, although per office the range was between 10 and 95 charts. Charts from experienced PCMH clinics numbered 128, while newer PCMH-certified-clinic charts numbered 242. There were 115 non–PCMH clinic chart reviews.
Patients across all three clinic groups ranged in age from 56 years to 61.6 years and were predominantly white women.
The non-PCMH offices, when compared with the certified clinics, were significantly less likely to document four of eight key data points to assess and manage chronic pain, including a patient’s pain severity (39% vs. 75%, P less than .001), functional disability (41% vs. 66%, P less than .001), psychosocial distress (38% vs. 54%, P = .01), or substance abuse (13% vs. 32%, P less than .001).
All clinics were inclined to address depression and employ nonpharmacologic approaches to pain, although opioids were prescribed chronically 57% of the time, regardless of PCMH certification status. All clinics were equally likely to ask patients to enter into an opioid-use contract, but noncertified practices were less likely to assess patients for the side effects of opioid use (56% vs. 68%, P = .02), perform a urine drug screen (27% vs. 48%), or review a state controlled-prescription report (38% vs. 50%, P = .005).
Although Dr. Elder concluded that the medical home model is conducive to better chronic pain management, the actual relationship between protocols and patient outcomes is still unknown. She also noted that, although there was not a statistically significant difference, practices that had been PCMH certified the longest did not perform as well as the practices with newer certification.
“That raised the question about whether some of the skills and benefits of becoming a PCMH wane with time,” she said.
Dr. Elder did not state any relevant disclosures.
On Twitter @whitneymcknight
AT NAPCRG 2014
Key clinical point: A patient-centered medical home model may be better at treating patients according to primary care pain management guidelines.
Major finding: Patient-centered medical home certification was associated with significantly more evidence-based chronic pain management protocols.
Data source: Chart review of chronic pain patients seen at 12 academic-affiliated primary care practices over 12 months.
Disclosures: Dr. Elder did not state any relevant disclosures.
PODCAST: Medical home model connects patients, docs via phone, e-mail
NEW YORK – A Canadian pilot program encourages patients and primary care physicians to communicate as often as necessary by phone or e-mail, rather than always in person, to improve continuity of care.
“We believe that if one has continuity of care, one can be a lot more creative in delivery models,” explained Dr. Garey Mazowita, president of the College of Family Physicians of Canada.
In an interview at the annual meeting of the North American Primary Care Research Group, Dr. Mazowita outlined the pilot program’s rationale and implementation, and he discussed the key role that trust between patient and physician plays in the success of such a program.
On Twitter @whitneymcknight
NEW YORK – A Canadian pilot program encourages patients and primary care physicians to communicate as often as necessary by phone or e-mail, rather than always in person, to improve continuity of care.
“We believe that if one has continuity of care, one can be a lot more creative in delivery models,” explained Dr. Garey Mazowita, president of the College of Family Physicians of Canada.
In an interview at the annual meeting of the North American Primary Care Research Group, Dr. Mazowita outlined the pilot program’s rationale and implementation, and he discussed the key role that trust between patient and physician plays in the success of such a program.
On Twitter @whitneymcknight
NEW YORK – A Canadian pilot program encourages patients and primary care physicians to communicate as often as necessary by phone or e-mail, rather than always in person, to improve continuity of care.
“We believe that if one has continuity of care, one can be a lot more creative in delivery models,” explained Dr. Garey Mazowita, president of the College of Family Physicians of Canada.
In an interview at the annual meeting of the North American Primary Care Research Group, Dr. Mazowita outlined the pilot program’s rationale and implementation, and he discussed the key role that trust between patient and physician plays in the success of such a program.
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM NAPCRG 2014
VIDEO: Family physicians can fill rural maternity care gaps
NEW YORK– Rather than relying on more obstetricians to practice in rural settings with limited access to maternity care, family physicians should be trusted to provide “excellent, quality care” to expectant mothers living in less populated areas – including delivering babies by cesarean section.
That’s the recommendation of Dr. Richard A. Young, director of research in family medicine at John Peters Smith Hospital, Fort Worth, Tex.
In a video interview at the annual meeting of the North American Primary Care Research Group, Dr. Young talked about the role family physicians can play in providing quality obstetrical care in underserved areas, and how they can collaborate with local obstetricians to ensure quality care even in complex cases.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
NEW YORK– Rather than relying on more obstetricians to practice in rural settings with limited access to maternity care, family physicians should be trusted to provide “excellent, quality care” to expectant mothers living in less populated areas – including delivering babies by cesarean section.
That’s the recommendation of Dr. Richard A. Young, director of research in family medicine at John Peters Smith Hospital, Fort Worth, Tex.
In a video interview at the annual meeting of the North American Primary Care Research Group, Dr. Young talked about the role family physicians can play in providing quality obstetrical care in underserved areas, and how they can collaborate with local obstetricians to ensure quality care even in complex cases.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
NEW YORK– Rather than relying on more obstetricians to practice in rural settings with limited access to maternity care, family physicians should be trusted to provide “excellent, quality care” to expectant mothers living in less populated areas – including delivering babies by cesarean section.
That’s the recommendation of Dr. Richard A. Young, director of research in family medicine at John Peters Smith Hospital, Fort Worth, Tex.
In a video interview at the annual meeting of the North American Primary Care Research Group, Dr. Young talked about the role family physicians can play in providing quality obstetrical care in underserved areas, and how they can collaborate with local obstetricians to ensure quality care even in complex cases.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
AT NAPCRG 2014
Ospemifene’s effect more comprehensive than its FDA indication
NATIONAL HARBOR, MD. – Ospemifene, a treatment for dyspareunia in postmenopausal women, also improved other symptoms of vaginal vulvar atrophy, according to a secondary analysis of two pivotal phase III trials presented here.
Marketed as Osphena (Shionogi), ospemifene is an oral estrogen agonist/antagonist approved in 2013 by the U.S. Food and Drug Administration for use in postmenopausal women with dyspareunia.
Had the drug been approved prior to FDA guidance added in 2013, however, ospemifene’s indications might have been more inclusive.
“A lot of people will look at this indication and [think], ‘Why would you just improve dyspareunia when you’re actually working with the estrogen receptor?’ ” said Dr. Ginger Constantine, a researcher at EndoRheum in Malvern, Pa., and a presenter at this year’s annual meeting of the North American Menopause Society, whose secondary analysis of the studies indicated the drug also eases vaginal dryness, itching, irritation, and painful urination in postmenopausal women.
“One would think that you would also be improving dryness ... and that is what you do see,” she said. However, when the patient-reported most bothersome symptom experienced at baseline is considered, different endpoints are achieved, resulting in packaging inserts that don’t necessarily reflect the full scope of what the product can successfully be used to treat, according to Dr. Constantine.
The estradiol acetate vaginal ring, Femring (Actavis), which was FDA-approved in 2002, has a more general indication, based on several combined study endpoints of relief from moderate to severe menopausal symptoms, including vulvar and vaginal atrophy.
Current guidance is more specific, calling for improvement in the patient-reported most bothersome symptom at baseline, as rated on a scale of 0-3, with 2 being moderate and 3 being severe. Dr. Constantine said this has led to controversy because women often have more than one symptom. “A patient might score a 3 for vaginal dryness and a 2 for dyspareunia, but she may not be so worried about her vaginal dryness,” Dr. Constantine said. “It’s her dyspareunia that’s more problematic [for her].”
Factoring in only the most bothersome symptom could impair investigators’ ability to detect statistical significance, and the result of predicating a product’s indication on the most bothersome symptom as part of a study’s construct has the potential to confuse both the clinician and the patient. “Most [postmenopausal] women have vaginal dryness, and now we’re asking them to tell us what ‘really’ bothers them, and they have to flip a coin,” Dr. Constantine said in response to an audience member’s question about whether the FDA’s labeling was too restrictive.
For the analysis, Dr. Constantine and her associates reviewed data from a 12-week, double-blind, pivotal phase III study of 826 postmenopausal women randomly assigned to either 30 mg of daily oral ospemifene, 60 mg daily of the study drug, or placebo.
Although 544 women across the study reported more than one symptom at baseline, the study’s endpoint was improvement in the most bothersome symptom. At baseline, a third of all participants reported experiencing vaginal dryness; 43% reported dyspareunia; and nearly a fifth reported vaginal itching and irritation. However, the No. 1 most bothersome symptom was dyspareunia, with nearly half, 45%, of all women reporting it as their chief complaint.
By the study’s end, the severity scores for the 120 women who’d reported dyspareunia as their most bothersome symptom were significantly improved from baseline (P = .023).
When dryness was assessed either with or without the consideration of a most bothersome symptom, then significant improvements were found (P = .001 and P = .021, respectively).
In a second pivotal, double-blind, phase III study reviewed by Dr. Constantine and her coinvestigators, 919 postmenopausal women were randomly assigned to 60 mg of daily oral ospemifene or placebo for 12 weeks, and were stratified according to the most bothersome symptom of either dyspareunia or dryness.
When compared with placebo, an improvement in dryness as the most bothersome symptom was not statistically significant (P = .0803), although an improvement from baseline in moderate to severe dryness was (P < .001).
Because the endpoints in both studies were improvement in the most bothersome symptom, the treatment was given the indication for dyspareunia only. As to why the statistical significance for dryness was diminished, Dr. Constantine said that because the women studied were allowed to use lubricants, which meant “the dryness really did get better,” it could have interfered with the results.
Compared with placebo, dyspareunia was significantly improved both as a moderate to severe symptom at baseline, and as the most bothersome symptom (P = .0003 and P < .0001, respectively).
Other symptoms such as irritation, itching, and painful urination also were improved, but did not achieve statistical significance in either study.
Given the data seen in this context, Dr. Constantine concluded that ospemifene’s limited indication was predicated more on study constructs than on failure to provide relief from other moderate to severe symptoms.
Dr. Constantine is a paid consultant and board member for Shionogi, the maker of Osphena.
On Twitter @whitneymcknight
NATIONAL HARBOR, MD. – Ospemifene, a treatment for dyspareunia in postmenopausal women, also improved other symptoms of vaginal vulvar atrophy, according to a secondary analysis of two pivotal phase III trials presented here.
Marketed as Osphena (Shionogi), ospemifene is an oral estrogen agonist/antagonist approved in 2013 by the U.S. Food and Drug Administration for use in postmenopausal women with dyspareunia.
Had the drug been approved prior to FDA guidance added in 2013, however, ospemifene’s indications might have been more inclusive.
“A lot of people will look at this indication and [think], ‘Why would you just improve dyspareunia when you’re actually working with the estrogen receptor?’ ” said Dr. Ginger Constantine, a researcher at EndoRheum in Malvern, Pa., and a presenter at this year’s annual meeting of the North American Menopause Society, whose secondary analysis of the studies indicated the drug also eases vaginal dryness, itching, irritation, and painful urination in postmenopausal women.
“One would think that you would also be improving dryness ... and that is what you do see,” she said. However, when the patient-reported most bothersome symptom experienced at baseline is considered, different endpoints are achieved, resulting in packaging inserts that don’t necessarily reflect the full scope of what the product can successfully be used to treat, according to Dr. Constantine.
The estradiol acetate vaginal ring, Femring (Actavis), which was FDA-approved in 2002, has a more general indication, based on several combined study endpoints of relief from moderate to severe menopausal symptoms, including vulvar and vaginal atrophy.
Current guidance is more specific, calling for improvement in the patient-reported most bothersome symptom at baseline, as rated on a scale of 0-3, with 2 being moderate and 3 being severe. Dr. Constantine said this has led to controversy because women often have more than one symptom. “A patient might score a 3 for vaginal dryness and a 2 for dyspareunia, but she may not be so worried about her vaginal dryness,” Dr. Constantine said. “It’s her dyspareunia that’s more problematic [for her].”
Factoring in only the most bothersome symptom could impair investigators’ ability to detect statistical significance, and the result of predicating a product’s indication on the most bothersome symptom as part of a study’s construct has the potential to confuse both the clinician and the patient. “Most [postmenopausal] women have vaginal dryness, and now we’re asking them to tell us what ‘really’ bothers them, and they have to flip a coin,” Dr. Constantine said in response to an audience member’s question about whether the FDA’s labeling was too restrictive.
For the analysis, Dr. Constantine and her associates reviewed data from a 12-week, double-blind, pivotal phase III study of 826 postmenopausal women randomly assigned to either 30 mg of daily oral ospemifene, 60 mg daily of the study drug, or placebo.
Although 544 women across the study reported more than one symptom at baseline, the study’s endpoint was improvement in the most bothersome symptom. At baseline, a third of all participants reported experiencing vaginal dryness; 43% reported dyspareunia; and nearly a fifth reported vaginal itching and irritation. However, the No. 1 most bothersome symptom was dyspareunia, with nearly half, 45%, of all women reporting it as their chief complaint.
By the study’s end, the severity scores for the 120 women who’d reported dyspareunia as their most bothersome symptom were significantly improved from baseline (P = .023).
When dryness was assessed either with or without the consideration of a most bothersome symptom, then significant improvements were found (P = .001 and P = .021, respectively).
In a second pivotal, double-blind, phase III study reviewed by Dr. Constantine and her coinvestigators, 919 postmenopausal women were randomly assigned to 60 mg of daily oral ospemifene or placebo for 12 weeks, and were stratified according to the most bothersome symptom of either dyspareunia or dryness.
When compared with placebo, an improvement in dryness as the most bothersome symptom was not statistically significant (P = .0803), although an improvement from baseline in moderate to severe dryness was (P < .001).
Because the endpoints in both studies were improvement in the most bothersome symptom, the treatment was given the indication for dyspareunia only. As to why the statistical significance for dryness was diminished, Dr. Constantine said that because the women studied were allowed to use lubricants, which meant “the dryness really did get better,” it could have interfered with the results.
Compared with placebo, dyspareunia was significantly improved both as a moderate to severe symptom at baseline, and as the most bothersome symptom (P = .0003 and P < .0001, respectively).
Other symptoms such as irritation, itching, and painful urination also were improved, but did not achieve statistical significance in either study.
Given the data seen in this context, Dr. Constantine concluded that ospemifene’s limited indication was predicated more on study constructs than on failure to provide relief from other moderate to severe symptoms.
Dr. Constantine is a paid consultant and board member for Shionogi, the maker of Osphena.
On Twitter @whitneymcknight
NATIONAL HARBOR, MD. – Ospemifene, a treatment for dyspareunia in postmenopausal women, also improved other symptoms of vaginal vulvar atrophy, according to a secondary analysis of two pivotal phase III trials presented here.
Marketed as Osphena (Shionogi), ospemifene is an oral estrogen agonist/antagonist approved in 2013 by the U.S. Food and Drug Administration for use in postmenopausal women with dyspareunia.
Had the drug been approved prior to FDA guidance added in 2013, however, ospemifene’s indications might have been more inclusive.
“A lot of people will look at this indication and [think], ‘Why would you just improve dyspareunia when you’re actually working with the estrogen receptor?’ ” said Dr. Ginger Constantine, a researcher at EndoRheum in Malvern, Pa., and a presenter at this year’s annual meeting of the North American Menopause Society, whose secondary analysis of the studies indicated the drug also eases vaginal dryness, itching, irritation, and painful urination in postmenopausal women.
“One would think that you would also be improving dryness ... and that is what you do see,” she said. However, when the patient-reported most bothersome symptom experienced at baseline is considered, different endpoints are achieved, resulting in packaging inserts that don’t necessarily reflect the full scope of what the product can successfully be used to treat, according to Dr. Constantine.
The estradiol acetate vaginal ring, Femring (Actavis), which was FDA-approved in 2002, has a more general indication, based on several combined study endpoints of relief from moderate to severe menopausal symptoms, including vulvar and vaginal atrophy.
Current guidance is more specific, calling for improvement in the patient-reported most bothersome symptom at baseline, as rated on a scale of 0-3, with 2 being moderate and 3 being severe. Dr. Constantine said this has led to controversy because women often have more than one symptom. “A patient might score a 3 for vaginal dryness and a 2 for dyspareunia, but she may not be so worried about her vaginal dryness,” Dr. Constantine said. “It’s her dyspareunia that’s more problematic [for her].”
Factoring in only the most bothersome symptom could impair investigators’ ability to detect statistical significance, and the result of predicating a product’s indication on the most bothersome symptom as part of a study’s construct has the potential to confuse both the clinician and the patient. “Most [postmenopausal] women have vaginal dryness, and now we’re asking them to tell us what ‘really’ bothers them, and they have to flip a coin,” Dr. Constantine said in response to an audience member’s question about whether the FDA’s labeling was too restrictive.
For the analysis, Dr. Constantine and her associates reviewed data from a 12-week, double-blind, pivotal phase III study of 826 postmenopausal women randomly assigned to either 30 mg of daily oral ospemifene, 60 mg daily of the study drug, or placebo.
Although 544 women across the study reported more than one symptom at baseline, the study’s endpoint was improvement in the most bothersome symptom. At baseline, a third of all participants reported experiencing vaginal dryness; 43% reported dyspareunia; and nearly a fifth reported vaginal itching and irritation. However, the No. 1 most bothersome symptom was dyspareunia, with nearly half, 45%, of all women reporting it as their chief complaint.
By the study’s end, the severity scores for the 120 women who’d reported dyspareunia as their most bothersome symptom were significantly improved from baseline (P = .023).
When dryness was assessed either with or without the consideration of a most bothersome symptom, then significant improvements were found (P = .001 and P = .021, respectively).
In a second pivotal, double-blind, phase III study reviewed by Dr. Constantine and her coinvestigators, 919 postmenopausal women were randomly assigned to 60 mg of daily oral ospemifene or placebo for 12 weeks, and were stratified according to the most bothersome symptom of either dyspareunia or dryness.
When compared with placebo, an improvement in dryness as the most bothersome symptom was not statistically significant (P = .0803), although an improvement from baseline in moderate to severe dryness was (P < .001).
Because the endpoints in both studies were improvement in the most bothersome symptom, the treatment was given the indication for dyspareunia only. As to why the statistical significance for dryness was diminished, Dr. Constantine said that because the women studied were allowed to use lubricants, which meant “the dryness really did get better,” it could have interfered with the results.
Compared with placebo, dyspareunia was significantly improved both as a moderate to severe symptom at baseline, and as the most bothersome symptom (P = .0003 and P < .0001, respectively).
Other symptoms such as irritation, itching, and painful urination also were improved, but did not achieve statistical significance in either study.
Given the data seen in this context, Dr. Constantine concluded that ospemifene’s limited indication was predicated more on study constructs than on failure to provide relief from other moderate to severe symptoms.
Dr. Constantine is a paid consultant and board member for Shionogi, the maker of Osphena.
On Twitter @whitneymcknight
AT THE NAMS 2014 ANNUAL MEETING
Key clinical point: Ospemifene could be an effective treatment for a range of moderate to severe menopausal symptoms.
Major finding: Ospemifine 60 mg daily, FDA-approved for dyspareunia, also yielded statistically significant improvement in vaginal dryness.
Data source: Secondary analysis of two randomly controlled, double-blind, pivotal phase III trials of 826 women treated with either 30 mg or 60 mg of daily oral ospemifene or placebo, and 919 women treated with either 60 mg ospemifene daily or placebo, stratified at randomization by most bothersome symptom at baseline.
Disclosures: Dr. Constantine is a paid consultant and board member for Shionogi, maker of Osphena.