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New persistent opioid use common after cancer surgery
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Prescribing guidelines and patient counseling need to change to combat new persistent opioid use, which authors confirmed is a common problem in patients undergoing surgery for early-stage cancer.
Major finding: The risk of new persistent opioid use was 10.4% (95% CI, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery.
Data source: Retrospective cohort study based on examination of deidentified insurance claims from employer health plans from 2010 to 2014.
Disclosures: First author Jay Soong-Jin Lee, MD, had no relationships to disclose. Coauthors reported relationships with Neuros Medical and Merck and Anesthesia Associates of Ann Arbor.
Young female hematologic cancer survivors have increased infertility risk
SAN ANTONIO – Young women who were survivors of hematologic cancer were more likely to have a diagnosis of infertility than cancer-free women, according to a large population-based study.
Using Ontario, Canada, universal health care databases, Maria Velez, MD, and her colleagues compared young female hematologic cancer survivors with age-matched women who were cancer-free, finding that 20.4% of the cancer survivors and 15% of the cancer-free women had an infertility diagnosis (P less than .001).
The matched cohort study used the Ontario Cancer Registry and identified 1,226 women aged 16-34 years who had been recurrence free for at least 5 years after a hematologic malignancy such that it captured cancer diagnoses made between 1992 and 2005. Each of these women was matched with four randomly selected, cancer-free women (n = 4,293) by the investigators, who took each woman’s age, location and socioeconomic status into account.
Then, the Ontario Health Insurance Plan database was queried to see which women in each group had claims billed under a diagnosis of infertility, denoted by ICD-9 code 628. Dr. Velez said that, for the survivor group, the investigators began tallying infertility diagnoses a full year after treatment was completed.
Pooling all types of hematologic cancer and adjusting for socioeconomic status, the overall relative risk for infertility was 1.35 for hematologic cancer survivors (95% confidence interval, 1.19-1.54; P less than .001).*
Dr. Velez and her colleagues also compared relative risk by type of hematologic cancer. The relative risk for infertility was 1.35 for survivors of non-Hodgkin lymphoma (n = 371); 1.30 for Hodgkin lymphoma (n = 731); and 1.71 for leukemia (n = 124). These were all statistically significant elevations in RR.
In the survivor group, the mean age at cancer diagnosis was 25.7 years, and patients were followed for a median 16.2 years. The mean age of infertility diagnosis for cancer survivors – 33 years – was not significantly different from that of the cancer-free group (32.8 years).
Dr. Velez and her colleagues also examined whether parity at the time of diagnosis was a factor. Cancer survivors who were nulliparous had a pooled relative risk of 1.35 for infertility, compared with the cancer-free women (P less than .001)*. A significantly elevated relative risk was seen for each individual cancer, except for leukemia. Dr. Velez said that this was likely a statistical artifact of the relatively small number of women who had this diagnosis.
The relative risk of an infertility diagnosis for women who were parous at the time of diagnosis was 1.21, a nonsignificant difference (95% CI, 0.80-1.83; P = .37). No individual diagnosis in this group carried a significantly elevated relative risk for infertility.
It’s difficult to know why parity might make a difference in risk of an infertility diagnosis, Dr. Velez said. There might be “nonbiologic” reasons, such as a difference in motivation to seek care for infertility or in desire for pregnancy, she said.
Strengths of the study included the large sample size and the population-based cohort design. The study was the first to use the ICD-9 code of infertility in cancer research, Dr. Velez said. Also, the relatively recent study period meant that patients received more modern cancer treatment regimens, making the data more relevant than some older Scandinavian studies that reached back into the 1960s, said Dr. Velez of the department of obstetrics and gynecology, in the division of reproductive endocrinology and infertility at Queen’s University, Kingston, Ont.
The study did not track the treatment regimen patients received, so it does not shed light on which chemotherapy regimens might be less gonadotoxic over time. The results are a call to include “the effect of cancer treatment on ovarian reserve as a secondary outcome” in clinical trials for cancer therapies, Dr. Velez said.
The study was conducted through the Institute for Clinical Evaluative Sciences and funded by the Faculty of Health Sciences at Queen's University. Dr. Velez reported that she has no financial disclosures.
[email protected]
On Twitter @karioakes
*Correction 11/14/17: An earlier version of this article misstated the P values.
SAN ANTONIO – Young women who were survivors of hematologic cancer were more likely to have a diagnosis of infertility than cancer-free women, according to a large population-based study.
Using Ontario, Canada, universal health care databases, Maria Velez, MD, and her colleagues compared young female hematologic cancer survivors with age-matched women who were cancer-free, finding that 20.4% of the cancer survivors and 15% of the cancer-free women had an infertility diagnosis (P less than .001).
The matched cohort study used the Ontario Cancer Registry and identified 1,226 women aged 16-34 years who had been recurrence free for at least 5 years after a hematologic malignancy such that it captured cancer diagnoses made between 1992 and 2005. Each of these women was matched with four randomly selected, cancer-free women (n = 4,293) by the investigators, who took each woman’s age, location and socioeconomic status into account.
Then, the Ontario Health Insurance Plan database was queried to see which women in each group had claims billed under a diagnosis of infertility, denoted by ICD-9 code 628. Dr. Velez said that, for the survivor group, the investigators began tallying infertility diagnoses a full year after treatment was completed.
Pooling all types of hematologic cancer and adjusting for socioeconomic status, the overall relative risk for infertility was 1.35 for hematologic cancer survivors (95% confidence interval, 1.19-1.54; P less than .001).*
Dr. Velez and her colleagues also compared relative risk by type of hematologic cancer. The relative risk for infertility was 1.35 for survivors of non-Hodgkin lymphoma (n = 371); 1.30 for Hodgkin lymphoma (n = 731); and 1.71 for leukemia (n = 124). These were all statistically significant elevations in RR.
In the survivor group, the mean age at cancer diagnosis was 25.7 years, and patients were followed for a median 16.2 years. The mean age of infertility diagnosis for cancer survivors – 33 years – was not significantly different from that of the cancer-free group (32.8 years).
Dr. Velez and her colleagues also examined whether parity at the time of diagnosis was a factor. Cancer survivors who were nulliparous had a pooled relative risk of 1.35 for infertility, compared with the cancer-free women (P less than .001)*. A significantly elevated relative risk was seen for each individual cancer, except for leukemia. Dr. Velez said that this was likely a statistical artifact of the relatively small number of women who had this diagnosis.
The relative risk of an infertility diagnosis for women who were parous at the time of diagnosis was 1.21, a nonsignificant difference (95% CI, 0.80-1.83; P = .37). No individual diagnosis in this group carried a significantly elevated relative risk for infertility.
It’s difficult to know why parity might make a difference in risk of an infertility diagnosis, Dr. Velez said. There might be “nonbiologic” reasons, such as a difference in motivation to seek care for infertility or in desire for pregnancy, she said.
Strengths of the study included the large sample size and the population-based cohort design. The study was the first to use the ICD-9 code of infertility in cancer research, Dr. Velez said. Also, the relatively recent study period meant that patients received more modern cancer treatment regimens, making the data more relevant than some older Scandinavian studies that reached back into the 1960s, said Dr. Velez of the department of obstetrics and gynecology, in the division of reproductive endocrinology and infertility at Queen’s University, Kingston, Ont.
The study did not track the treatment regimen patients received, so it does not shed light on which chemotherapy regimens might be less gonadotoxic over time. The results are a call to include “the effect of cancer treatment on ovarian reserve as a secondary outcome” in clinical trials for cancer therapies, Dr. Velez said.
The study was conducted through the Institute for Clinical Evaluative Sciences and funded by the Faculty of Health Sciences at Queen's University. Dr. Velez reported that she has no financial disclosures.
[email protected]
On Twitter @karioakes
*Correction 11/14/17: An earlier version of this article misstated the P values.
SAN ANTONIO – Young women who were survivors of hematologic cancer were more likely to have a diagnosis of infertility than cancer-free women, according to a large population-based study.
Using Ontario, Canada, universal health care databases, Maria Velez, MD, and her colleagues compared young female hematologic cancer survivors with age-matched women who were cancer-free, finding that 20.4% of the cancer survivors and 15% of the cancer-free women had an infertility diagnosis (P less than .001).
The matched cohort study used the Ontario Cancer Registry and identified 1,226 women aged 16-34 years who had been recurrence free for at least 5 years after a hematologic malignancy such that it captured cancer diagnoses made between 1992 and 2005. Each of these women was matched with four randomly selected, cancer-free women (n = 4,293) by the investigators, who took each woman’s age, location and socioeconomic status into account.
Then, the Ontario Health Insurance Plan database was queried to see which women in each group had claims billed under a diagnosis of infertility, denoted by ICD-9 code 628. Dr. Velez said that, for the survivor group, the investigators began tallying infertility diagnoses a full year after treatment was completed.
Pooling all types of hematologic cancer and adjusting for socioeconomic status, the overall relative risk for infertility was 1.35 for hematologic cancer survivors (95% confidence interval, 1.19-1.54; P less than .001).*
Dr. Velez and her colleagues also compared relative risk by type of hematologic cancer. The relative risk for infertility was 1.35 for survivors of non-Hodgkin lymphoma (n = 371); 1.30 for Hodgkin lymphoma (n = 731); and 1.71 for leukemia (n = 124). These were all statistically significant elevations in RR.
In the survivor group, the mean age at cancer diagnosis was 25.7 years, and patients were followed for a median 16.2 years. The mean age of infertility diagnosis for cancer survivors – 33 years – was not significantly different from that of the cancer-free group (32.8 years).
Dr. Velez and her colleagues also examined whether parity at the time of diagnosis was a factor. Cancer survivors who were nulliparous had a pooled relative risk of 1.35 for infertility, compared with the cancer-free women (P less than .001)*. A significantly elevated relative risk was seen for each individual cancer, except for leukemia. Dr. Velez said that this was likely a statistical artifact of the relatively small number of women who had this diagnosis.
The relative risk of an infertility diagnosis for women who were parous at the time of diagnosis was 1.21, a nonsignificant difference (95% CI, 0.80-1.83; P = .37). No individual diagnosis in this group carried a significantly elevated relative risk for infertility.
It’s difficult to know why parity might make a difference in risk of an infertility diagnosis, Dr. Velez said. There might be “nonbiologic” reasons, such as a difference in motivation to seek care for infertility or in desire for pregnancy, she said.
Strengths of the study included the large sample size and the population-based cohort design. The study was the first to use the ICD-9 code of infertility in cancer research, Dr. Velez said. Also, the relatively recent study period meant that patients received more modern cancer treatment regimens, making the data more relevant than some older Scandinavian studies that reached back into the 1960s, said Dr. Velez of the department of obstetrics and gynecology, in the division of reproductive endocrinology and infertility at Queen’s University, Kingston, Ont.
The study did not track the treatment regimen patients received, so it does not shed light on which chemotherapy regimens might be less gonadotoxic over time. The results are a call to include “the effect of cancer treatment on ovarian reserve as a secondary outcome” in clinical trials for cancer therapies, Dr. Velez said.
The study was conducted through the Institute for Clinical Evaluative Sciences and funded by the Faculty of Health Sciences at Queen's University. Dr. Velez reported that she has no financial disclosures.
[email protected]
On Twitter @karioakes
*Correction 11/14/17: An earlier version of this article misstated the P values.
AT ASRM 2017
Key clinical point:
Major finding: Young women who survived hematologic cancer had a 20.4% risk of infertility, compared with 15% among cancer-free controls (P less than .001). The overall relative risk for infertility among hematologic cancer survivors was 1.35.
Data source: Prospective, age-matched cohort study of 1,226 cancer survivors and 4,293 cancer-free controls.
Disclosures: Dr. Velez reported that she had no disclosures. The Institute for Clinical Evaluative Services in Toronto funded the study.
Warfarin may protect against cancer
Warfarin, the most frequently used anticoagulant worldwide, may be associated with a lower incidence of cancer incidence across a broad range of cancer types, according to results of a large, retrospective population-based cohort study.
Compared with non-users, warfarin users had a significantly lower rate of cancer overall (age- and sex-adjusted incidence rate ratio [IRR], .84; 95% CI, 0.82-0.86) and in common organ-specific cancer sites, according to the study, which included nearly 1.3 million individuals over 50 years of age in the Norwegian National Registry.
“An unintended consequence of this switch to new oral anticoagulants may be an increased incidence of cancer, which is an important consideration for public health,” Gry S. Haaland, MD, Department of Biomedicine, University of Bergen, Norway and her colleagues wrote in the report.
The study included population registry data on nearly 1.3 million Norwegians, correlated with more data from a prescription database and cancer registry in that country.
While there was no correlation between warfarin use and colon cancer, there were significantly reduced age- and sex-adjusted IRRs associated with other common organ-specific sites such as lung (.80); prostate (.69); and breast (.90), Dr. Haaland and her colleagues reported.
A subgroup analysis of the 33,313 patients (35.8%) with atrial fibrillation showed a significantly lower IRR for all cancer sites (IRR, .625) and most prevalent sites (compared with nonusers): IRR for prostate was.60; lung was.39; and the IRR for female breast cancer was .72.
The potential anticancer effects of warfarin have been suggested in various experimental cancer models. In particular, warfarin at doses not reaching anticoagulation levels has been shown to inhibits AXL receptor tyrosine kinase–dependent tumorigenesis, the authors said.
Beyond those models, there have been “conflicting conclusions” in the medical literature regarding whether warfarin protects against cancer, they added.
While some studies have shown no such association, Dr. Haaland and colleagues say they used a “stricter definition” of warfarin use that included at least 6 months of a warfarin prescription. Moreover, they only counted cancer cases that were diagnosed at least 2 years after the first prescription.
“Our data indicate that warfarin provides a possible cancer protection, a finding that may have important implications for choosing medications for patients who need anticoagulation,” the authors concluded.
However, further study is needed to better understand the mechanisms by which warfarin exerts this protective effect, they added.
Warfarin, the most frequently used anticoagulant worldwide, may be associated with a lower incidence of cancer incidence across a broad range of cancer types, according to results of a large, retrospective population-based cohort study.
Compared with non-users, warfarin users had a significantly lower rate of cancer overall (age- and sex-adjusted incidence rate ratio [IRR], .84; 95% CI, 0.82-0.86) and in common organ-specific cancer sites, according to the study, which included nearly 1.3 million individuals over 50 years of age in the Norwegian National Registry.
“An unintended consequence of this switch to new oral anticoagulants may be an increased incidence of cancer, which is an important consideration for public health,” Gry S. Haaland, MD, Department of Biomedicine, University of Bergen, Norway and her colleagues wrote in the report.
The study included population registry data on nearly 1.3 million Norwegians, correlated with more data from a prescription database and cancer registry in that country.
While there was no correlation between warfarin use and colon cancer, there were significantly reduced age- and sex-adjusted IRRs associated with other common organ-specific sites such as lung (.80); prostate (.69); and breast (.90), Dr. Haaland and her colleagues reported.
A subgroup analysis of the 33,313 patients (35.8%) with atrial fibrillation showed a significantly lower IRR for all cancer sites (IRR, .625) and most prevalent sites (compared with nonusers): IRR for prostate was.60; lung was.39; and the IRR for female breast cancer was .72.
The potential anticancer effects of warfarin have been suggested in various experimental cancer models. In particular, warfarin at doses not reaching anticoagulation levels has been shown to inhibits AXL receptor tyrosine kinase–dependent tumorigenesis, the authors said.
Beyond those models, there have been “conflicting conclusions” in the medical literature regarding whether warfarin protects against cancer, they added.
While some studies have shown no such association, Dr. Haaland and colleagues say they used a “stricter definition” of warfarin use that included at least 6 months of a warfarin prescription. Moreover, they only counted cancer cases that were diagnosed at least 2 years after the first prescription.
“Our data indicate that warfarin provides a possible cancer protection, a finding that may have important implications for choosing medications for patients who need anticoagulation,” the authors concluded.
However, further study is needed to better understand the mechanisms by which warfarin exerts this protective effect, they added.
Warfarin, the most frequently used anticoagulant worldwide, may be associated with a lower incidence of cancer incidence across a broad range of cancer types, according to results of a large, retrospective population-based cohort study.
Compared with non-users, warfarin users had a significantly lower rate of cancer overall (age- and sex-adjusted incidence rate ratio [IRR], .84; 95% CI, 0.82-0.86) and in common organ-specific cancer sites, according to the study, which included nearly 1.3 million individuals over 50 years of age in the Norwegian National Registry.
“An unintended consequence of this switch to new oral anticoagulants may be an increased incidence of cancer, which is an important consideration for public health,” Gry S. Haaland, MD, Department of Biomedicine, University of Bergen, Norway and her colleagues wrote in the report.
The study included population registry data on nearly 1.3 million Norwegians, correlated with more data from a prescription database and cancer registry in that country.
While there was no correlation between warfarin use and colon cancer, there were significantly reduced age- and sex-adjusted IRRs associated with other common organ-specific sites such as lung (.80); prostate (.69); and breast (.90), Dr. Haaland and her colleagues reported.
A subgroup analysis of the 33,313 patients (35.8%) with atrial fibrillation showed a significantly lower IRR for all cancer sites (IRR, .625) and most prevalent sites (compared with nonusers): IRR for prostate was.60; lung was.39; and the IRR for female breast cancer was .72.
The potential anticancer effects of warfarin have been suggested in various experimental cancer models. In particular, warfarin at doses not reaching anticoagulation levels has been shown to inhibits AXL receptor tyrosine kinase–dependent tumorigenesis, the authors said.
Beyond those models, there have been “conflicting conclusions” in the medical literature regarding whether warfarin protects against cancer, they added.
While some studies have shown no such association, Dr. Haaland and colleagues say they used a “stricter definition” of warfarin use that included at least 6 months of a warfarin prescription. Moreover, they only counted cancer cases that were diagnosed at least 2 years after the first prescription.
“Our data indicate that warfarin provides a possible cancer protection, a finding that may have important implications for choosing medications for patients who need anticoagulation,” the authors concluded.
However, further study is needed to better understand the mechanisms by which warfarin exerts this protective effect, they added.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Warfarin may have broad anticancer effects, a finding which could have implications for choice of anticoagulant.
Major finding: Compared with warfarin non-users, warfarin users had a significantly lower rate of cancer overall (age- and sex-adjusted incidence rate ratio [IRR], 0.84) and in common organ-specific cancer sites.
Data source: A retrospective population-based cohort study of nearly 1.3 million individuals over 50 years of age in the Norwegian National Registry.
Disclosures: James B. Lorens, PhD, reported ownership interest in BerGenBio ASA.
The pediatrician detective and high lead levels
I am not going to tell you about the dangers of lead, as it is well known and publicized, but I will tell you my family’s story with lead.
In 2012, 1 year after my younger daughter was born, I took her for her 1-year checkup. As I would do with any of my pediatric patients at this age, I took her for a lead level check. Never during my residency training or my first few years of practice as a pediatrician have I encountered a positive lead level. So when I opened the lab result sheet, I thought I would be shredding it the next moment. Well, that didn’t happen. It turned out that her lead level was 7 mcg/dL! Not too high, but detectable. The only question that kept on coming back over the next month or so was a big WHY? Why my child? Now my older daughter’s lead level was normal at her 1-year visit. We had just moved into a new house before my youngest daughter was born. I thought, it has to do with the house, and since my 1-year-old was putting everything in her mouth at this stage, then she must be getting the lead that way.
So it was not the house or the wall pipes that were contaminated with lead. It was not our food that we cooked, otherwise my nanny’s daughter would have had a high lead level, as she ate the same food we ate almost daily. Our family did not travel recently. So what was it that my family had or ate that my neighbor or nanny’s child did not?
The answer was thyme. It is an herb that we mix with olive oil and spread on dough – I call it Lebanese pizza. That is one thing that my nanny and her child never ate, but we did. It was a long painful month of investigation, elimination, and anxiety. I called the public health department in Phoenix and they stated that lots of imported spices were contaminated with lead. There were two theories as to why this might happen. The first one is that the spice dealers would add lead to increase the weight of the spices to get more money. The second is that the spice fields were close to factories that used lead in their manufacturing, and somehow the lead would contaminate the nearby fields where the spices grew.
The type of thyme we used was bought in Syria and packaged in Lebanon. It was not the pure organic type that we usually got from our grandparents in our southern Lebanese village. This packaged thyme had lot of nuts added to it to give it more flavor.
The public health department official asked that I send her some samples of all the spices that I had. I packed up to ten different spice bags including the thyme. Two weeks later she called me, stating that the lead level allowable in spices must be less than 10, and that our thyme’s lead level was 900!
We got rid of all the spices, and have never eaten that packaged spice again. My kids’ lead levels dropped nicely afterward and back to normal. That is our story with lead. Now it seems like a mini-detective story and even fun, but the anxiety that I experienced until we figured out the cause was not!
Dr. Faddoul is a private practice pediatrician in La Canada Flintridge, Calif.
I am not going to tell you about the dangers of lead, as it is well known and publicized, but I will tell you my family’s story with lead.
In 2012, 1 year after my younger daughter was born, I took her for her 1-year checkup. As I would do with any of my pediatric patients at this age, I took her for a lead level check. Never during my residency training or my first few years of practice as a pediatrician have I encountered a positive lead level. So when I opened the lab result sheet, I thought I would be shredding it the next moment. Well, that didn’t happen. It turned out that her lead level was 7 mcg/dL! Not too high, but detectable. The only question that kept on coming back over the next month or so was a big WHY? Why my child? Now my older daughter’s lead level was normal at her 1-year visit. We had just moved into a new house before my youngest daughter was born. I thought, it has to do with the house, and since my 1-year-old was putting everything in her mouth at this stage, then she must be getting the lead that way.
So it was not the house or the wall pipes that were contaminated with lead. It was not our food that we cooked, otherwise my nanny’s daughter would have had a high lead level, as she ate the same food we ate almost daily. Our family did not travel recently. So what was it that my family had or ate that my neighbor or nanny’s child did not?
The answer was thyme. It is an herb that we mix with olive oil and spread on dough – I call it Lebanese pizza. That is one thing that my nanny and her child never ate, but we did. It was a long painful month of investigation, elimination, and anxiety. I called the public health department in Phoenix and they stated that lots of imported spices were contaminated with lead. There were two theories as to why this might happen. The first one is that the spice dealers would add lead to increase the weight of the spices to get more money. The second is that the spice fields were close to factories that used lead in their manufacturing, and somehow the lead would contaminate the nearby fields where the spices grew.
The type of thyme we used was bought in Syria and packaged in Lebanon. It was not the pure organic type that we usually got from our grandparents in our southern Lebanese village. This packaged thyme had lot of nuts added to it to give it more flavor.
The public health department official asked that I send her some samples of all the spices that I had. I packed up to ten different spice bags including the thyme. Two weeks later she called me, stating that the lead level allowable in spices must be less than 10, and that our thyme’s lead level was 900!
We got rid of all the spices, and have never eaten that packaged spice again. My kids’ lead levels dropped nicely afterward and back to normal. That is our story with lead. Now it seems like a mini-detective story and even fun, but the anxiety that I experienced until we figured out the cause was not!
Dr. Faddoul is a private practice pediatrician in La Canada Flintridge, Calif.
I am not going to tell you about the dangers of lead, as it is well known and publicized, but I will tell you my family’s story with lead.
In 2012, 1 year after my younger daughter was born, I took her for her 1-year checkup. As I would do with any of my pediatric patients at this age, I took her for a lead level check. Never during my residency training or my first few years of practice as a pediatrician have I encountered a positive lead level. So when I opened the lab result sheet, I thought I would be shredding it the next moment. Well, that didn’t happen. It turned out that her lead level was 7 mcg/dL! Not too high, but detectable. The only question that kept on coming back over the next month or so was a big WHY? Why my child? Now my older daughter’s lead level was normal at her 1-year visit. We had just moved into a new house before my youngest daughter was born. I thought, it has to do with the house, and since my 1-year-old was putting everything in her mouth at this stage, then she must be getting the lead that way.
So it was not the house or the wall pipes that were contaminated with lead. It was not our food that we cooked, otherwise my nanny’s daughter would have had a high lead level, as she ate the same food we ate almost daily. Our family did not travel recently. So what was it that my family had or ate that my neighbor or nanny’s child did not?
The answer was thyme. It is an herb that we mix with olive oil and spread on dough – I call it Lebanese pizza. That is one thing that my nanny and her child never ate, but we did. It was a long painful month of investigation, elimination, and anxiety. I called the public health department in Phoenix and they stated that lots of imported spices were contaminated with lead. There were two theories as to why this might happen. The first one is that the spice dealers would add lead to increase the weight of the spices to get more money. The second is that the spice fields were close to factories that used lead in their manufacturing, and somehow the lead would contaminate the nearby fields where the spices grew.
The type of thyme we used was bought in Syria and packaged in Lebanon. It was not the pure organic type that we usually got from our grandparents in our southern Lebanese village. This packaged thyme had lot of nuts added to it to give it more flavor.
The public health department official asked that I send her some samples of all the spices that I had. I packed up to ten different spice bags including the thyme. Two weeks later she called me, stating that the lead level allowable in spices must be less than 10, and that our thyme’s lead level was 900!
We got rid of all the spices, and have never eaten that packaged spice again. My kids’ lead levels dropped nicely afterward and back to normal. That is our story with lead. Now it seems like a mini-detective story and even fun, but the anxiety that I experienced until we figured out the cause was not!
Dr. Faddoul is a private practice pediatrician in La Canada Flintridge, Calif.
Hiatal hernia repair more common at time of sleeve gastrectomy, compared with RYGB
SAN DIEGO – Concomitant hiatal hernia repair is significantly more common at the time of laparoscopic sleeve gastrectomy, compared with laparoscopic Roux-en-Y gastric bypass, according to a retrospective analysis.
“GERD [gastroesophageal reflux disease] is common in patients with a high body mass index,” lead study author Dino Spaniolas, MD, said at the annual clinical congress of the American College of Surgeons. “In fact, 35%-40% of patients who undergo bariatric surgery are diagnosed with a hiatal hernia, and the majority of them are diagnosed during surgery.”
In an effort to assess the differences in practice patterns in the performance of hiatal hernia repair during laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), the researchers evaluated the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program public use files from 2015. They limited the analysis to LSG and LRYGB and also excluded revision procedures and patients with a history of foregut surgery.
In all, 130,686 patients were included in the study. Their mean age was 45 years, 79% were female, 75% were Caucasian, and their mean body mass index was 45.7 kg/m2. Most (70%) underwent LSG, while the remainder underwent LRYGB.
At baseline, a greater proportion of the LRYGB patients had a history of GERD than did LSG patients (37.2% vs. 28.6%, respectively; P less than .0001). They were also more likely to have hypertension (54.1% vs. 47.9%; P less than .0001), hyperlipidemia (29.9% vs. 23.2%; P less than .0001), and diabetes (35.5% vs. 23.3%; P less than .0001). Overall, about 15% of patients had a concomitant hiatal hernia repair in addition to their bariatric surgery.
Next, the investigators found what Dr. Spaniolas termed “the GERD paradox”: Although the LRYGB patients were more likely to have GERD before surgery, they were much less likely to undergo a hiatal hernia repair in addition to their bariatric procedure. Specifically, concomitant hiatal hernia repair was performed in 21% of LSG patients, compared with only 10.8% of LRYGB patients (P less than .0001). After investigators controlled for baseline BMI, preoperative GERD, and other patient characteristics, they found that LSG patients were 2.14 times more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
“This is a retrospective review, but nevertheless, I think we can conclude that these findings suggest that concomitant hiatal hernia repair is significantly more common after LSG, compared with LRYGB, despite having less GERD preoperatively,” Dr. Spaniolas said. “This suggests that there is a nationwide difference in the intraoperative management of hiatal hernia based on the type of planned bariatric procedure. This practice pattern needs to be considered while retrospectively assessing GERD-related outcomes of bariatric surgery in the future.”
Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
SAN DIEGO – Concomitant hiatal hernia repair is significantly more common at the time of laparoscopic sleeve gastrectomy, compared with laparoscopic Roux-en-Y gastric bypass, according to a retrospective analysis.
“GERD [gastroesophageal reflux disease] is common in patients with a high body mass index,” lead study author Dino Spaniolas, MD, said at the annual clinical congress of the American College of Surgeons. “In fact, 35%-40% of patients who undergo bariatric surgery are diagnosed with a hiatal hernia, and the majority of them are diagnosed during surgery.”
In an effort to assess the differences in practice patterns in the performance of hiatal hernia repair during laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), the researchers evaluated the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program public use files from 2015. They limited the analysis to LSG and LRYGB and also excluded revision procedures and patients with a history of foregut surgery.
In all, 130,686 patients were included in the study. Their mean age was 45 years, 79% were female, 75% were Caucasian, and their mean body mass index was 45.7 kg/m2. Most (70%) underwent LSG, while the remainder underwent LRYGB.
At baseline, a greater proportion of the LRYGB patients had a history of GERD than did LSG patients (37.2% vs. 28.6%, respectively; P less than .0001). They were also more likely to have hypertension (54.1% vs. 47.9%; P less than .0001), hyperlipidemia (29.9% vs. 23.2%; P less than .0001), and diabetes (35.5% vs. 23.3%; P less than .0001). Overall, about 15% of patients had a concomitant hiatal hernia repair in addition to their bariatric surgery.
Next, the investigators found what Dr. Spaniolas termed “the GERD paradox”: Although the LRYGB patients were more likely to have GERD before surgery, they were much less likely to undergo a hiatal hernia repair in addition to their bariatric procedure. Specifically, concomitant hiatal hernia repair was performed in 21% of LSG patients, compared with only 10.8% of LRYGB patients (P less than .0001). After investigators controlled for baseline BMI, preoperative GERD, and other patient characteristics, they found that LSG patients were 2.14 times more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
“This is a retrospective review, but nevertheless, I think we can conclude that these findings suggest that concomitant hiatal hernia repair is significantly more common after LSG, compared with LRYGB, despite having less GERD preoperatively,” Dr. Spaniolas said. “This suggests that there is a nationwide difference in the intraoperative management of hiatal hernia based on the type of planned bariatric procedure. This practice pattern needs to be considered while retrospectively assessing GERD-related outcomes of bariatric surgery in the future.”
Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
SAN DIEGO – Concomitant hiatal hernia repair is significantly more common at the time of laparoscopic sleeve gastrectomy, compared with laparoscopic Roux-en-Y gastric bypass, according to a retrospective analysis.
“GERD [gastroesophageal reflux disease] is common in patients with a high body mass index,” lead study author Dino Spaniolas, MD, said at the annual clinical congress of the American College of Surgeons. “In fact, 35%-40% of patients who undergo bariatric surgery are diagnosed with a hiatal hernia, and the majority of them are diagnosed during surgery.”
In an effort to assess the differences in practice patterns in the performance of hiatal hernia repair during laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), the researchers evaluated the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program public use files from 2015. They limited the analysis to LSG and LRYGB and also excluded revision procedures and patients with a history of foregut surgery.
In all, 130,686 patients were included in the study. Their mean age was 45 years, 79% were female, 75% were Caucasian, and their mean body mass index was 45.7 kg/m2. Most (70%) underwent LSG, while the remainder underwent LRYGB.
At baseline, a greater proportion of the LRYGB patients had a history of GERD than did LSG patients (37.2% vs. 28.6%, respectively; P less than .0001). They were also more likely to have hypertension (54.1% vs. 47.9%; P less than .0001), hyperlipidemia (29.9% vs. 23.2%; P less than .0001), and diabetes (35.5% vs. 23.3%; P less than .0001). Overall, about 15% of patients had a concomitant hiatal hernia repair in addition to their bariatric surgery.
Next, the investigators found what Dr. Spaniolas termed “the GERD paradox”: Although the LRYGB patients were more likely to have GERD before surgery, they were much less likely to undergo a hiatal hernia repair in addition to their bariatric procedure. Specifically, concomitant hiatal hernia repair was performed in 21% of LSG patients, compared with only 10.8% of LRYGB patients (P less than .0001). After investigators controlled for baseline BMI, preoperative GERD, and other patient characteristics, they found that LSG patients were 2.14 times more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
“This is a retrospective review, but nevertheless, I think we can conclude that these findings suggest that concomitant hiatal hernia repair is significantly more common after LSG, compared with LRYGB, despite having less GERD preoperatively,” Dr. Spaniolas said. “This suggests that there is a nationwide difference in the intraoperative management of hiatal hernia based on the type of planned bariatric procedure. This practice pattern needs to be considered while retrospectively assessing GERD-related outcomes of bariatric surgery in the future.”
Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
AT THE ACS CLINICAL CONGRESS
Key clinical point: LSG patients are more likely to undergo concomitant hiatal hernia repair, compared with LRYGB patients.
Major finding: According to multivariate analysis, LSG patients were more likely to undergo concomitant HH repair (odds ratio, 2.14).
Study details: A retrospective analysis of 130,686 patients who underwent bariatric surgery in 2015.
Disclosures: Dr. Spaniolas disclosed that he has received research support from Merck and that he is a consultant for Mallinckrodt.
Sickle cell patients suffer discrimination, poor care – and shorter lives
For more than a year, NeDina Brocks-Capla avoided one room in her large, brightly colored San Francisco house – the bathroom on the second floor.
“It was really hard to bathe in here, and I found myself not wanting to touch the walls,” she explained. The bathroom is where Ms. Brocks-Capla’s son Kareem Jones died in 2013 at age 36, from sickle cell disease.
It’s not just the loss of her son that upsets Ms. Brocks-Capla; she believes that if Mr. Jones had gotten the proper medical care, he might still be alive today.
Sickle cell disease is an inherited disorder that causes some red blood cells to bend into a crescent shape. The misshapen, inflexible cells clog the blood vessels, preventing blood from circulating oxygen properly, which can cause chronic pain, multiorgan failure, and stroke. About 100,000 people in the United States have sickle cell disease, and most of them are African American.
Patients and experts alike say it’s no surprise then that while life expectancy for almost every major malady is improving, patients with sickle cell disease can expect to die younger than they did 20 years ago. In 1994, life expectancy for sickle cell patients was 42 for men and 48 for women. By 2005, life expectancy had dipped to 38 for men and 42 for women.
Sickle cell disease is “a microcosm of how issues of race, ethnicity and identity come into conflict with issues of health care,” said Keith Wailoo, PhD, a professor at Princeton University who writes about the history of the disease.
It is also an example of the broader discrimination experienced by African Americans in the medical system. Nearly a third report that they have experienced discrimination when going to the doctor, according to a poll by NPR, Robert Wood Johnson Foundation, and Harvard T.H. Chan School of Public Health.
“One of the national crises in health care is the care for adult sickle cell,” said leading researcher and physician Elliott Vichinsky, MD, who started the sickle cell center at UCSF Benioff Children’s Hospital Oakland in 1978. “This group of people can live much longer with the management we have, and they’re dying because we don’t have access to care.”
Indeed, with the proper care, Dr. Vichinsky’s center and the handful of other specialty clinics like it across the country have been able to increase life expectancy for sickle cell patients well into their 60s.
Dr. Vichinsky’s patient Derek Perkins, 45, knows he has already beaten the odds. He sits in an exam room decorated with cartoon characters at Children’s Hospital Oakland, but this is the adult sickle cell clinic. He’s been Dr. Vichinsky’s patient since childhood.
“Without the sickle cell clinic here in Oakland, I don’t know what I would do. I don’t know anywhere else I could go,” Mr. Perkins said.
When Mr. Perkins was 27, he once ended up at a different hospital where doctors misdiagnosed his crisis. He went into a coma and was near death before his mother insisted he be transferred.
“Dr. Vichinsky was able to get me here to Children’s Hospital, and he found out what was wrong and within 18 hours – all I needed was an emergency blood transfusion and I was awake,” Mr. Perkins recalled.
Kareem Jones lived just across the bay from Mr. Perkins, but he had a profoundly different experience.
Mr. Jones’ mother, Ms. Brocks-Capla, said her son received excellent medical care as a child, but once he turned 18 and aged out of his pediatric program, it felt like falling off a cliff. Mr. Jones was sent to a clinic at San Francisco General Hospital, but it was open only for a half-day, one day each week. If he was sick any other day, he had two options: leave a voicemail for a clinic nurse or go to the emergency room. “That’s not comprehensive care – that’s not consistent care for a disease of this type,” said Ms. Brocks-Capla.
Ms. Brocks-Capla is a retired supervisor at a worker’s compensation firm. She knew how to navigate the health care system, but she couldn’t get her son the care he needed. Like most sickle cell patients, Mr. Jones had frequent pain crises. Usually he ended up in the emergency department where, Ms. Brocks-Capla said, the doctors didn’t seem to know much about sickle cell disease.
When she tried to explain her son’s pain to the doctors and nurses, she recalled, “they say have a seat. ‘He can’t have a seat! Can’t you see him?’ ”
Studies have found that sickle cell patients have to wait up to 50% longer for help in the emergency department than do other pain patients. The opioid crisis has made things even worse, Dr. Vichinsky added, as patients in terrible pain are likely to be seen as drug seekers with addiction problems rather than patients in need.
Despite his illness, Mr. Jones fought to have a normal life. He lived with his girlfriend, had a daughter, and worked as much as he could between pain crises. He was an avid San Francisco Giants fan.
For years, he took hydroxyurea, but it had side effects, and after a while Mr. Jones had to stop taking it. “And that was it, because you know there isn’t any other medication out there,” said Ms. Brocks-Capla.
Indeed, hydroxyurea, which the Food and Drug Administration first approved in 1967 as a cancer drug, was the only drug on the market to treat sickle cell during Mr. Jones’ lifetime. In July, the FDA approved a second drug, Endari (L-glutamine oral powder), specifically to treat patients with sickle cell disease.
Funding by the federal government and private foundations for the disease pales in comparison to other disorders. Cystic fibrosis offers a good comparison. It is another inherited disorder that requires complex care and most often occurs in Caucasians. Cystic fibrosis gets 7-11 times more funding per patient than does sickle cell disease, according to a 2013 study in the journal Blood. From 2010 to 2013 alone, the FDA approved five new drugs for the treatment of cystic fibrosis.
“There’s no question in my mind that class and color are major factors in impairing their survival. Without question,” Dr. Vichinsky said of sickle cell patients. “The death rate is increasing. The quality of care is going down.”
Without a new medication, Mr. Jones got progressively worse. At 36, his kidneys began to fail, and he had to go on dialysis. He ended up in the hospital, with the worst pain of his life. The doctors stabilized him and gave him pain meds but did not diagnose the underlying cause of the crisis. He was released to his mother’s care, still in incredible pain.
At home, Ms. Brocks-Capla ran him a warm bath to try to soothe his pain and went downstairs to get him a change of clothes. As she came back up the stairs, she heard loud banging against the bathroom walls.
“So I run into the bathroom and he’s having a seizure. And I didn’t know what to do. I was like, ‘Oh come on, come on. Don’t do this. Don’t do this to me.’ ”
She called 911. The paramedics came but couldn’t revive him. “He died here with me,” she said.
It turned out Mr. Jones had a series of small strokes. His organs were in failure, something Ms. Brocks-Capla said the hospital missed. She believes his death could have been prevented with consistent care – the kind he got as a child. Dr. Vichinsky thinks she is probably right.
“I would say 40% or more of the deaths I’ve had recently have been preventable – I mean totally preventable,” he said, but he got to the cases too late. “It makes me so angry. I’ve spent my life trying to help these people, and the harder part is you can change this – this isn’t a knowledge issue. It’s an access issue.”
Dr. Vichinsky’s center and others like it have made major advances in screening patients for the early signs of organ failure and intervening to prevent premature death. Patients at these clinics live 2 decades longer than the average sickle cell patient.
Good care for sickle cell requires time and training for physicians, but it often doesn’t pay well, because many patients are on Medicaid or other government insurance programs. The result is that most adult sickle cell patients still struggle even to access treatments that have been around for decades, Dr. Vichinsky said.
The phenomenon is nothing new — the disease that used to be known as sickle cell anemia has had a long and sordid past. It was first identified in 1910 and helped launch the field of molecular biology. But most of the research was used to study science rather than improving care for sickle cell patients, Dr. Vichinsky said.
In the 1960s and 1970s, sickle cell became a lightning rod for the civil rights movement. At the time, the average patient died before age 20. The Black Panther Party took up the cause and began testing people at its “survival conferences” across the country.
“I’m sure we tested over four-and-a-half-thousand people for sickle cell anemia last night – and I think that the voter registration is running neck and neck with it,” Black Panther Party Chairman Bobby Seale told news crews at an event in Oakland in 1972.
The movement grew, and Washington listened. “It is a sad and shameful fact that the causes of this disease have been largely neglected throughout our history,” President Richard Nixon told Congress in 1971. “We cannot rewrite this record of neglect, but we can reverse it. To this end, this administration is increasing its budget for research and treatment of sickle cell disease.”
For a while, funding did increase, newborn screening took hold, and by the 1990s, life expectancy had doubled, with patients living into their 40s. But over time, funding waned, clinics closed, and life expectancy started dropping again.
Dr. Vichinsky pushes against that trend for patients like Derek Perkins. The father of four looks healthy and robust, but like most sickle cell patients, he has episodes of extreme pain and has problems with his kidneys, heart, hips, and breathing. Keeping him thriving requires regular checkups and constant monitoring for potential problems.
“The program Dr. Vichinsky is running here, I feel I owe my life to [it],” said Mr. Perkins. “If it wasn’t for him and the things that he did for me, my family wouldn’t have me.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.
For more than a year, NeDina Brocks-Capla avoided one room in her large, brightly colored San Francisco house – the bathroom on the second floor.
“It was really hard to bathe in here, and I found myself not wanting to touch the walls,” she explained. The bathroom is where Ms. Brocks-Capla’s son Kareem Jones died in 2013 at age 36, from sickle cell disease.
It’s not just the loss of her son that upsets Ms. Brocks-Capla; she believes that if Mr. Jones had gotten the proper medical care, he might still be alive today.
Sickle cell disease is an inherited disorder that causes some red blood cells to bend into a crescent shape. The misshapen, inflexible cells clog the blood vessels, preventing blood from circulating oxygen properly, which can cause chronic pain, multiorgan failure, and stroke. About 100,000 people in the United States have sickle cell disease, and most of them are African American.
Patients and experts alike say it’s no surprise then that while life expectancy for almost every major malady is improving, patients with sickle cell disease can expect to die younger than they did 20 years ago. In 1994, life expectancy for sickle cell patients was 42 for men and 48 for women. By 2005, life expectancy had dipped to 38 for men and 42 for women.
Sickle cell disease is “a microcosm of how issues of race, ethnicity and identity come into conflict with issues of health care,” said Keith Wailoo, PhD, a professor at Princeton University who writes about the history of the disease.
It is also an example of the broader discrimination experienced by African Americans in the medical system. Nearly a third report that they have experienced discrimination when going to the doctor, according to a poll by NPR, Robert Wood Johnson Foundation, and Harvard T.H. Chan School of Public Health.
“One of the national crises in health care is the care for adult sickle cell,” said leading researcher and physician Elliott Vichinsky, MD, who started the sickle cell center at UCSF Benioff Children’s Hospital Oakland in 1978. “This group of people can live much longer with the management we have, and they’re dying because we don’t have access to care.”
Indeed, with the proper care, Dr. Vichinsky’s center and the handful of other specialty clinics like it across the country have been able to increase life expectancy for sickle cell patients well into their 60s.
Dr. Vichinsky’s patient Derek Perkins, 45, knows he has already beaten the odds. He sits in an exam room decorated with cartoon characters at Children’s Hospital Oakland, but this is the adult sickle cell clinic. He’s been Dr. Vichinsky’s patient since childhood.
“Without the sickle cell clinic here in Oakland, I don’t know what I would do. I don’t know anywhere else I could go,” Mr. Perkins said.
When Mr. Perkins was 27, he once ended up at a different hospital where doctors misdiagnosed his crisis. He went into a coma and was near death before his mother insisted he be transferred.
“Dr. Vichinsky was able to get me here to Children’s Hospital, and he found out what was wrong and within 18 hours – all I needed was an emergency blood transfusion and I was awake,” Mr. Perkins recalled.
Kareem Jones lived just across the bay from Mr. Perkins, but he had a profoundly different experience.
Mr. Jones’ mother, Ms. Brocks-Capla, said her son received excellent medical care as a child, but once he turned 18 and aged out of his pediatric program, it felt like falling off a cliff. Mr. Jones was sent to a clinic at San Francisco General Hospital, but it was open only for a half-day, one day each week. If he was sick any other day, he had two options: leave a voicemail for a clinic nurse or go to the emergency room. “That’s not comprehensive care – that’s not consistent care for a disease of this type,” said Ms. Brocks-Capla.
Ms. Brocks-Capla is a retired supervisor at a worker’s compensation firm. She knew how to navigate the health care system, but she couldn’t get her son the care he needed. Like most sickle cell patients, Mr. Jones had frequent pain crises. Usually he ended up in the emergency department where, Ms. Brocks-Capla said, the doctors didn’t seem to know much about sickle cell disease.
When she tried to explain her son’s pain to the doctors and nurses, she recalled, “they say have a seat. ‘He can’t have a seat! Can’t you see him?’ ”
Studies have found that sickle cell patients have to wait up to 50% longer for help in the emergency department than do other pain patients. The opioid crisis has made things even worse, Dr. Vichinsky added, as patients in terrible pain are likely to be seen as drug seekers with addiction problems rather than patients in need.
Despite his illness, Mr. Jones fought to have a normal life. He lived with his girlfriend, had a daughter, and worked as much as he could between pain crises. He was an avid San Francisco Giants fan.
For years, he took hydroxyurea, but it had side effects, and after a while Mr. Jones had to stop taking it. “And that was it, because you know there isn’t any other medication out there,” said Ms. Brocks-Capla.
Indeed, hydroxyurea, which the Food and Drug Administration first approved in 1967 as a cancer drug, was the only drug on the market to treat sickle cell during Mr. Jones’ lifetime. In July, the FDA approved a second drug, Endari (L-glutamine oral powder), specifically to treat patients with sickle cell disease.
Funding by the federal government and private foundations for the disease pales in comparison to other disorders. Cystic fibrosis offers a good comparison. It is another inherited disorder that requires complex care and most often occurs in Caucasians. Cystic fibrosis gets 7-11 times more funding per patient than does sickle cell disease, according to a 2013 study in the journal Blood. From 2010 to 2013 alone, the FDA approved five new drugs for the treatment of cystic fibrosis.
“There’s no question in my mind that class and color are major factors in impairing their survival. Without question,” Dr. Vichinsky said of sickle cell patients. “The death rate is increasing. The quality of care is going down.”
Without a new medication, Mr. Jones got progressively worse. At 36, his kidneys began to fail, and he had to go on dialysis. He ended up in the hospital, with the worst pain of his life. The doctors stabilized him and gave him pain meds but did not diagnose the underlying cause of the crisis. He was released to his mother’s care, still in incredible pain.
At home, Ms. Brocks-Capla ran him a warm bath to try to soothe his pain and went downstairs to get him a change of clothes. As she came back up the stairs, she heard loud banging against the bathroom walls.
“So I run into the bathroom and he’s having a seizure. And I didn’t know what to do. I was like, ‘Oh come on, come on. Don’t do this. Don’t do this to me.’ ”
She called 911. The paramedics came but couldn’t revive him. “He died here with me,” she said.
It turned out Mr. Jones had a series of small strokes. His organs were in failure, something Ms. Brocks-Capla said the hospital missed. She believes his death could have been prevented with consistent care – the kind he got as a child. Dr. Vichinsky thinks she is probably right.
“I would say 40% or more of the deaths I’ve had recently have been preventable – I mean totally preventable,” he said, but he got to the cases too late. “It makes me so angry. I’ve spent my life trying to help these people, and the harder part is you can change this – this isn’t a knowledge issue. It’s an access issue.”
Dr. Vichinsky’s center and others like it have made major advances in screening patients for the early signs of organ failure and intervening to prevent premature death. Patients at these clinics live 2 decades longer than the average sickle cell patient.
Good care for sickle cell requires time and training for physicians, but it often doesn’t pay well, because many patients are on Medicaid or other government insurance programs. The result is that most adult sickle cell patients still struggle even to access treatments that have been around for decades, Dr. Vichinsky said.
The phenomenon is nothing new — the disease that used to be known as sickle cell anemia has had a long and sordid past. It was first identified in 1910 and helped launch the field of molecular biology. But most of the research was used to study science rather than improving care for sickle cell patients, Dr. Vichinsky said.
In the 1960s and 1970s, sickle cell became a lightning rod for the civil rights movement. At the time, the average patient died before age 20. The Black Panther Party took up the cause and began testing people at its “survival conferences” across the country.
“I’m sure we tested over four-and-a-half-thousand people for sickle cell anemia last night – and I think that the voter registration is running neck and neck with it,” Black Panther Party Chairman Bobby Seale told news crews at an event in Oakland in 1972.
The movement grew, and Washington listened. “It is a sad and shameful fact that the causes of this disease have been largely neglected throughout our history,” President Richard Nixon told Congress in 1971. “We cannot rewrite this record of neglect, but we can reverse it. To this end, this administration is increasing its budget for research and treatment of sickle cell disease.”
For a while, funding did increase, newborn screening took hold, and by the 1990s, life expectancy had doubled, with patients living into their 40s. But over time, funding waned, clinics closed, and life expectancy started dropping again.
Dr. Vichinsky pushes against that trend for patients like Derek Perkins. The father of four looks healthy and robust, but like most sickle cell patients, he has episodes of extreme pain and has problems with his kidneys, heart, hips, and breathing. Keeping him thriving requires regular checkups and constant monitoring for potential problems.
“The program Dr. Vichinsky is running here, I feel I owe my life to [it],” said Mr. Perkins. “If it wasn’t for him and the things that he did for me, my family wouldn’t have me.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.
For more than a year, NeDina Brocks-Capla avoided one room in her large, brightly colored San Francisco house – the bathroom on the second floor.
“It was really hard to bathe in here, and I found myself not wanting to touch the walls,” she explained. The bathroom is where Ms. Brocks-Capla’s son Kareem Jones died in 2013 at age 36, from sickle cell disease.
It’s not just the loss of her son that upsets Ms. Brocks-Capla; she believes that if Mr. Jones had gotten the proper medical care, he might still be alive today.
Sickle cell disease is an inherited disorder that causes some red blood cells to bend into a crescent shape. The misshapen, inflexible cells clog the blood vessels, preventing blood from circulating oxygen properly, which can cause chronic pain, multiorgan failure, and stroke. About 100,000 people in the United States have sickle cell disease, and most of them are African American.
Patients and experts alike say it’s no surprise then that while life expectancy for almost every major malady is improving, patients with sickle cell disease can expect to die younger than they did 20 years ago. In 1994, life expectancy for sickle cell patients was 42 for men and 48 for women. By 2005, life expectancy had dipped to 38 for men and 42 for women.
Sickle cell disease is “a microcosm of how issues of race, ethnicity and identity come into conflict with issues of health care,” said Keith Wailoo, PhD, a professor at Princeton University who writes about the history of the disease.
It is also an example of the broader discrimination experienced by African Americans in the medical system. Nearly a third report that they have experienced discrimination when going to the doctor, according to a poll by NPR, Robert Wood Johnson Foundation, and Harvard T.H. Chan School of Public Health.
“One of the national crises in health care is the care for adult sickle cell,” said leading researcher and physician Elliott Vichinsky, MD, who started the sickle cell center at UCSF Benioff Children’s Hospital Oakland in 1978. “This group of people can live much longer with the management we have, and they’re dying because we don’t have access to care.”
Indeed, with the proper care, Dr. Vichinsky’s center and the handful of other specialty clinics like it across the country have been able to increase life expectancy for sickle cell patients well into their 60s.
Dr. Vichinsky’s patient Derek Perkins, 45, knows he has already beaten the odds. He sits in an exam room decorated with cartoon characters at Children’s Hospital Oakland, but this is the adult sickle cell clinic. He’s been Dr. Vichinsky’s patient since childhood.
“Without the sickle cell clinic here in Oakland, I don’t know what I would do. I don’t know anywhere else I could go,” Mr. Perkins said.
When Mr. Perkins was 27, he once ended up at a different hospital where doctors misdiagnosed his crisis. He went into a coma and was near death before his mother insisted he be transferred.
“Dr. Vichinsky was able to get me here to Children’s Hospital, and he found out what was wrong and within 18 hours – all I needed was an emergency blood transfusion and I was awake,” Mr. Perkins recalled.
Kareem Jones lived just across the bay from Mr. Perkins, but he had a profoundly different experience.
Mr. Jones’ mother, Ms. Brocks-Capla, said her son received excellent medical care as a child, but once he turned 18 and aged out of his pediatric program, it felt like falling off a cliff. Mr. Jones was sent to a clinic at San Francisco General Hospital, but it was open only for a half-day, one day each week. If he was sick any other day, he had two options: leave a voicemail for a clinic nurse or go to the emergency room. “That’s not comprehensive care – that’s not consistent care for a disease of this type,” said Ms. Brocks-Capla.
Ms. Brocks-Capla is a retired supervisor at a worker’s compensation firm. She knew how to navigate the health care system, but she couldn’t get her son the care he needed. Like most sickle cell patients, Mr. Jones had frequent pain crises. Usually he ended up in the emergency department where, Ms. Brocks-Capla said, the doctors didn’t seem to know much about sickle cell disease.
When she tried to explain her son’s pain to the doctors and nurses, she recalled, “they say have a seat. ‘He can’t have a seat! Can’t you see him?’ ”
Studies have found that sickle cell patients have to wait up to 50% longer for help in the emergency department than do other pain patients. The opioid crisis has made things even worse, Dr. Vichinsky added, as patients in terrible pain are likely to be seen as drug seekers with addiction problems rather than patients in need.
Despite his illness, Mr. Jones fought to have a normal life. He lived with his girlfriend, had a daughter, and worked as much as he could between pain crises. He was an avid San Francisco Giants fan.
For years, he took hydroxyurea, but it had side effects, and after a while Mr. Jones had to stop taking it. “And that was it, because you know there isn’t any other medication out there,” said Ms. Brocks-Capla.
Indeed, hydroxyurea, which the Food and Drug Administration first approved in 1967 as a cancer drug, was the only drug on the market to treat sickle cell during Mr. Jones’ lifetime. In July, the FDA approved a second drug, Endari (L-glutamine oral powder), specifically to treat patients with sickle cell disease.
Funding by the federal government and private foundations for the disease pales in comparison to other disorders. Cystic fibrosis offers a good comparison. It is another inherited disorder that requires complex care and most often occurs in Caucasians. Cystic fibrosis gets 7-11 times more funding per patient than does sickle cell disease, according to a 2013 study in the journal Blood. From 2010 to 2013 alone, the FDA approved five new drugs for the treatment of cystic fibrosis.
“There’s no question in my mind that class and color are major factors in impairing their survival. Without question,” Dr. Vichinsky said of sickle cell patients. “The death rate is increasing. The quality of care is going down.”
Without a new medication, Mr. Jones got progressively worse. At 36, his kidneys began to fail, and he had to go on dialysis. He ended up in the hospital, with the worst pain of his life. The doctors stabilized him and gave him pain meds but did not diagnose the underlying cause of the crisis. He was released to his mother’s care, still in incredible pain.
At home, Ms. Brocks-Capla ran him a warm bath to try to soothe his pain and went downstairs to get him a change of clothes. As she came back up the stairs, she heard loud banging against the bathroom walls.
“So I run into the bathroom and he’s having a seizure. And I didn’t know what to do. I was like, ‘Oh come on, come on. Don’t do this. Don’t do this to me.’ ”
She called 911. The paramedics came but couldn’t revive him. “He died here with me,” she said.
It turned out Mr. Jones had a series of small strokes. His organs were in failure, something Ms. Brocks-Capla said the hospital missed. She believes his death could have been prevented with consistent care – the kind he got as a child. Dr. Vichinsky thinks she is probably right.
“I would say 40% or more of the deaths I’ve had recently have been preventable – I mean totally preventable,” he said, but he got to the cases too late. “It makes me so angry. I’ve spent my life trying to help these people, and the harder part is you can change this – this isn’t a knowledge issue. It’s an access issue.”
Dr. Vichinsky’s center and others like it have made major advances in screening patients for the early signs of organ failure and intervening to prevent premature death. Patients at these clinics live 2 decades longer than the average sickle cell patient.
Good care for sickle cell requires time and training for physicians, but it often doesn’t pay well, because many patients are on Medicaid or other government insurance programs. The result is that most adult sickle cell patients still struggle even to access treatments that have been around for decades, Dr. Vichinsky said.
The phenomenon is nothing new — the disease that used to be known as sickle cell anemia has had a long and sordid past. It was first identified in 1910 and helped launch the field of molecular biology. But most of the research was used to study science rather than improving care for sickle cell patients, Dr. Vichinsky said.
In the 1960s and 1970s, sickle cell became a lightning rod for the civil rights movement. At the time, the average patient died before age 20. The Black Panther Party took up the cause and began testing people at its “survival conferences” across the country.
“I’m sure we tested over four-and-a-half-thousand people for sickle cell anemia last night – and I think that the voter registration is running neck and neck with it,” Black Panther Party Chairman Bobby Seale told news crews at an event in Oakland in 1972.
The movement grew, and Washington listened. “It is a sad and shameful fact that the causes of this disease have been largely neglected throughout our history,” President Richard Nixon told Congress in 1971. “We cannot rewrite this record of neglect, but we can reverse it. To this end, this administration is increasing its budget for research and treatment of sickle cell disease.”
For a while, funding did increase, newborn screening took hold, and by the 1990s, life expectancy had doubled, with patients living into their 40s. But over time, funding waned, clinics closed, and life expectancy started dropping again.
Dr. Vichinsky pushes against that trend for patients like Derek Perkins. The father of four looks healthy and robust, but like most sickle cell patients, he has episodes of extreme pain and has problems with his kidneys, heart, hips, and breathing. Keeping him thriving requires regular checkups and constant monitoring for potential problems.
“The program Dr. Vichinsky is running here, I feel I owe my life to [it],” said Mr. Perkins. “If it wasn’t for him and the things that he did for me, my family wouldn’t have me.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.
Weight recidivism after bariatric surgery: What constitutes failure?
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
AGA created the Obesity Practice Guide to help gastroenterologists integrate and operationalize obesity management in their practice for financial success. Learn more at www.gastro.org/obesity.
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
AGA created the Obesity Practice Guide to help gastroenterologists integrate and operationalize obesity management in their practice for financial success. Learn more at www.gastro.org/obesity.
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
AGA created the Obesity Practice Guide to help gastroenterologists integrate and operationalize obesity management in their practice for financial success. Learn more at www.gastro.org/obesity.
AT OBESITY WEEK 2017
Key clinical point: Many patients regain weight after bariatric surgery, but experts argue over the definition of long-term treatment failure, for which there is no standard.
Major finding: After 5 or more years of follow-up, failure rates range from 25% to 70% depending on definition of unacceptable weight regain.
Data source: A retrospective review.
Disclosures: Dr. Morell and Dr. Martyn reported no financial relationships relevant to this topic.
Methotrexate holiday linked to better flu vaccine immunogenicity
SAN DIEGO – Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.
The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.
The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.
In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).
The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.
For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.
The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.
At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.
The researchers reported that there was no appreciable increase in RA disease activity.
Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.
The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.
Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.
Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.
“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”
Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.
SAN DIEGO – Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.
The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.
The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.
In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).
The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.
For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.
The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.
At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.
The researchers reported that there was no appreciable increase in RA disease activity.
Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.
The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.
Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.
Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.
“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”
Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.
SAN DIEGO – Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.
The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.
The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.
In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).
The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.
For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.
The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.
At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.
The researchers reported that there was no appreciable increase in RA disease activity.
Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.
The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.
Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.
Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.
“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”
Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.
AT ACR 2017
Key clinical point:
Major finding: More than three-quarters of patients who had briefly stopped methotrexate and 54.5% of patients who kept using methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains at 4 weeks.
Data source: A randomized controlled trial of 320 patients with RA who were taking methotrexate.
Disclosures: The study was funded by Green Cross Corp. The presenter reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross and Hanmi Pharmaceutical.
VIDEO: Biologic use during pregnancy had no impact on serious infection risks in infants
SAN DIEGO – Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.
“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.
In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.
Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.
In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).
“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.
Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
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SAN DIEGO – Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.
“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.
In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.
Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.
In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).
“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.
Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.
“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.
In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.
Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.
In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).
“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.
Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACR 2017
Key clinical point:
Major finding: Infections occurred in 4% of infants born to mothers with RA treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy.
Study details: An observational cohort study of 1,156 pregnant women with RA.
Disclosures: Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.
MACRA Monday: Poor HbA1c control
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
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Measure #1: Diabetes: HbA1c Poor Control
The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.
What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.
Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Measure #1: Diabetes: HbA1c Poor Control
The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.
What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.
Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Measure #1: Diabetes: HbA1c Poor Control
The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.
What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.
Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).
