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Late thrombectomy for stroke has low number needed to treat for benefit
LOS ANGELES – The number of ischemic stroke patients with a clinical core mismatch showing salvageable tissue who need to be treated with thrombectomy to obtain a significant benefit on functional outcomes is just 2 when the time frame from last known well extends out to 24 hours, according a subanalysis of results from the DAWN trial.
The Jan. 4, 2018, publication of the DAWN trial revealed that patients with ischemic strokes can benefit from thrombectomy long after the time window generally thought to afford benefits had closed (N Engl J Med. 2018;378:11-21). The procedure yielded significant benefits in functional outcomes at 90 days in patients with a clinical core mismatch showing salvageable tissue.
The results are important because health care systems must now make decisions about allocating resources for the treatment of these patients, which will include installing imaging techniques and expertise at various centers. “It will be practical in some primary stroke centers and not in others. We’re going to see a lot of interesting research about what frontline hospitals should do. There are lots of options at that screening step, and we’re going to need experience to see what’s best. It won’t be the same answer for everyone,” Jeffrey Saver, MD, said during a press conference announcing the results at the meeting, which was sponsored by the American Heart Association. Dr. Saver is director of the stroke unit at the University of California, Los Angeles, and professor of clinical neurology at the university.
The DAWN trial randomized 206 patients to thrombectomy plus standard care or standard care alone. The study was halted at an enrollment of 206 patients because of overwhelming efficacy. To be eligible, the patients had to have a mismatch between the severity of clinical deficit and the infarct volume as measured via automated analysis (RAPID software, SchemaView) of diffusion-weighted MRI or perfusion CT. They had to have substantial clinical deficits, but limited infarct size, with specific criteria varying with age, National Institutes of Health Stroke Scale score, and infarct size.
The NNT for an mRS score of 0 (asymptomatic) was 19. For freedom from disability (mRS, 0-1), the NNT was 4. For functional independence (mRS, 0-2), it was 3. To achieve ambulatory status (mRS, 0-3), it was 3. To avoid a requirement for constant care (mRS, 0-4), the NNT was 9.
To achieve any reduction in disability at all, the NNT was 2. This value was identical when looking at patients in the 6- to 12-hour window and those in the 12- to 24-hour window. However, the nature of the benefit was different. “In the late window (12-24 hours), outcomes went from really bad to pretty good. In the early window, it was somewhat bad to very good. So it’s still better to be treated early,” Dr. Saver said.
In short, for every 100 patients treated, 50 would gain an improvement in disability-related quality of life, and 36 would gain functional independence. In the 6- to 12-hour group, 45 of every 100 patients would experience lower disability as a result of treatment, as would 56 of every 100 treated patients in the 12- to 24-hour group.
Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
LOS ANGELES – The number of ischemic stroke patients with a clinical core mismatch showing salvageable tissue who need to be treated with thrombectomy to obtain a significant benefit on functional outcomes is just 2 when the time frame from last known well extends out to 24 hours, according a subanalysis of results from the DAWN trial.
The Jan. 4, 2018, publication of the DAWN trial revealed that patients with ischemic strokes can benefit from thrombectomy long after the time window generally thought to afford benefits had closed (N Engl J Med. 2018;378:11-21). The procedure yielded significant benefits in functional outcomes at 90 days in patients with a clinical core mismatch showing salvageable tissue.
The results are important because health care systems must now make decisions about allocating resources for the treatment of these patients, which will include installing imaging techniques and expertise at various centers. “It will be practical in some primary stroke centers and not in others. We’re going to see a lot of interesting research about what frontline hospitals should do. There are lots of options at that screening step, and we’re going to need experience to see what’s best. It won’t be the same answer for everyone,” Jeffrey Saver, MD, said during a press conference announcing the results at the meeting, which was sponsored by the American Heart Association. Dr. Saver is director of the stroke unit at the University of California, Los Angeles, and professor of clinical neurology at the university.
The DAWN trial randomized 206 patients to thrombectomy plus standard care or standard care alone. The study was halted at an enrollment of 206 patients because of overwhelming efficacy. To be eligible, the patients had to have a mismatch between the severity of clinical deficit and the infarct volume as measured via automated analysis (RAPID software, SchemaView) of diffusion-weighted MRI or perfusion CT. They had to have substantial clinical deficits, but limited infarct size, with specific criteria varying with age, National Institutes of Health Stroke Scale score, and infarct size.
The NNT for an mRS score of 0 (asymptomatic) was 19. For freedom from disability (mRS, 0-1), the NNT was 4. For functional independence (mRS, 0-2), it was 3. To achieve ambulatory status (mRS, 0-3), it was 3. To avoid a requirement for constant care (mRS, 0-4), the NNT was 9.
To achieve any reduction in disability at all, the NNT was 2. This value was identical when looking at patients in the 6- to 12-hour window and those in the 12- to 24-hour window. However, the nature of the benefit was different. “In the late window (12-24 hours), outcomes went from really bad to pretty good. In the early window, it was somewhat bad to very good. So it’s still better to be treated early,” Dr. Saver said.
In short, for every 100 patients treated, 50 would gain an improvement in disability-related quality of life, and 36 would gain functional independence. In the 6- to 12-hour group, 45 of every 100 patients would experience lower disability as a result of treatment, as would 56 of every 100 treated patients in the 12- to 24-hour group.
Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
LOS ANGELES – The number of ischemic stroke patients with a clinical core mismatch showing salvageable tissue who need to be treated with thrombectomy to obtain a significant benefit on functional outcomes is just 2 when the time frame from last known well extends out to 24 hours, according a subanalysis of results from the DAWN trial.
The Jan. 4, 2018, publication of the DAWN trial revealed that patients with ischemic strokes can benefit from thrombectomy long after the time window generally thought to afford benefits had closed (N Engl J Med. 2018;378:11-21). The procedure yielded significant benefits in functional outcomes at 90 days in patients with a clinical core mismatch showing salvageable tissue.
The results are important because health care systems must now make decisions about allocating resources for the treatment of these patients, which will include installing imaging techniques and expertise at various centers. “It will be practical in some primary stroke centers and not in others. We’re going to see a lot of interesting research about what frontline hospitals should do. There are lots of options at that screening step, and we’re going to need experience to see what’s best. It won’t be the same answer for everyone,” Jeffrey Saver, MD, said during a press conference announcing the results at the meeting, which was sponsored by the American Heart Association. Dr. Saver is director of the stroke unit at the University of California, Los Angeles, and professor of clinical neurology at the university.
The DAWN trial randomized 206 patients to thrombectomy plus standard care or standard care alone. The study was halted at an enrollment of 206 patients because of overwhelming efficacy. To be eligible, the patients had to have a mismatch between the severity of clinical deficit and the infarct volume as measured via automated analysis (RAPID software, SchemaView) of diffusion-weighted MRI or perfusion CT. They had to have substantial clinical deficits, but limited infarct size, with specific criteria varying with age, National Institutes of Health Stroke Scale score, and infarct size.
The NNT for an mRS score of 0 (asymptomatic) was 19. For freedom from disability (mRS, 0-1), the NNT was 4. For functional independence (mRS, 0-2), it was 3. To achieve ambulatory status (mRS, 0-3), it was 3. To avoid a requirement for constant care (mRS, 0-4), the NNT was 9.
To achieve any reduction in disability at all, the NNT was 2. This value was identical when looking at patients in the 6- to 12-hour window and those in the 12- to 24-hour window. However, the nature of the benefit was different. “In the late window (12-24 hours), outcomes went from really bad to pretty good. In the early window, it was somewhat bad to very good. So it’s still better to be treated early,” Dr. Saver said.
In short, for every 100 patients treated, 50 would gain an improvement in disability-related quality of life, and 36 would gain functional independence. In the 6- to 12-hour group, 45 of every 100 patients would experience lower disability as a result of treatment, as would 56 of every 100 treated patients in the 12- to 24-hour group.
Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
REPORTING FROM ISC 2018
Key clinical point:
Major finding: To achieve a functional improvement at 90 days, the number needed to treat was 2.
Data source: Subanalysis of the randomized, controlled DAWN trial (n = 206).
Disclosures: Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
Source: Saver J et al. ISC 2018 abstract LB3
LAA occlusion boosts anticoagulants’ protection
ORLANDO – When patients with atrial fibrillation have a history of cardioembolic events despite optimal anticoagulant therapy, treatment with left atrial appendage occlusion can substantially improve protection against future events, according to a multicenter review of 22 patients.
During the 2 years prior to undergoing left atrial appendage (LAA) occlusion, the 22 atrial fibrillation (AF) patients studied had a total of 44 cardioembolic events despite receiving “optimal” treatment with an oral anticoagulant, including nine patients with one event, six patients with two events, five patients with three events, and two patients with four events each, Xavier Freixa, MD, said at the annual International AF Symposium. In contrast, during a median follow-up of 1.8 years after their procedure additional events occurred in just two patients – one with a stroke, the other with a transient ischemic attack, while the remaining 20 patients remained free of any additional events.
The analysis also revealed that the two patients who had cardioembolic events following their LAA occlusion had been withdrawn from oral anticoagulant treatment by their physicians, who had done this with a “false feeling of comfort,” said Dr. Freixa, an interventional cardiologist at the University Hospital Clinic of Barcelona. These two patients were among three patients maintained on dual-antiplatelet therapy rather than on an oral anticoagulant following LAA occlusion. The remaining 19 patients had remained on either warfarin, a novel oral anticoagulant, or both.
The study included patients from eight Spanish centers who underwent LAA occlusion during June 2009–June 2017, and included 14 with nonvalvular AF and 8 with valvular AF who had all undergone prior valve surgery. None of the 22 patients had a contraindication for treatment with an oral anticoagulant. They averaged about 69 years of age. Prior to their procedure, 18 had at least one stroke or transient ischemic attack, and the remaining 4 patients had at least one systemic embolism. Nineteen patients underwent occlusion with either an Amplatzer Cardiac Plug or Amplatzer Amulet device, two received a Watchman device, and one patient received a LAmbre device. All of the closure procedures were successful, with no complications.
“I think any device will do well for these patients as long as we occlude the LAA,” Dr. Freixa said.
[email protected]
On Twitter @mitchelzoler
SOURCE: Freixa X et al. AF Symposium 2018 Abstract 1821.
ORLANDO – When patients with atrial fibrillation have a history of cardioembolic events despite optimal anticoagulant therapy, treatment with left atrial appendage occlusion can substantially improve protection against future events, according to a multicenter review of 22 patients.
During the 2 years prior to undergoing left atrial appendage (LAA) occlusion, the 22 atrial fibrillation (AF) patients studied had a total of 44 cardioembolic events despite receiving “optimal” treatment with an oral anticoagulant, including nine patients with one event, six patients with two events, five patients with three events, and two patients with four events each, Xavier Freixa, MD, said at the annual International AF Symposium. In contrast, during a median follow-up of 1.8 years after their procedure additional events occurred in just two patients – one with a stroke, the other with a transient ischemic attack, while the remaining 20 patients remained free of any additional events.
The analysis also revealed that the two patients who had cardioembolic events following their LAA occlusion had been withdrawn from oral anticoagulant treatment by their physicians, who had done this with a “false feeling of comfort,” said Dr. Freixa, an interventional cardiologist at the University Hospital Clinic of Barcelona. These two patients were among three patients maintained on dual-antiplatelet therapy rather than on an oral anticoagulant following LAA occlusion. The remaining 19 patients had remained on either warfarin, a novel oral anticoagulant, or both.
The study included patients from eight Spanish centers who underwent LAA occlusion during June 2009–June 2017, and included 14 with nonvalvular AF and 8 with valvular AF who had all undergone prior valve surgery. None of the 22 patients had a contraindication for treatment with an oral anticoagulant. They averaged about 69 years of age. Prior to their procedure, 18 had at least one stroke or transient ischemic attack, and the remaining 4 patients had at least one systemic embolism. Nineteen patients underwent occlusion with either an Amplatzer Cardiac Plug or Amplatzer Amulet device, two received a Watchman device, and one patient received a LAmbre device. All of the closure procedures were successful, with no complications.
“I think any device will do well for these patients as long as we occlude the LAA,” Dr. Freixa said.
[email protected]
On Twitter @mitchelzoler
SOURCE: Freixa X et al. AF Symposium 2018 Abstract 1821.
ORLANDO – When patients with atrial fibrillation have a history of cardioembolic events despite optimal anticoagulant therapy, treatment with left atrial appendage occlusion can substantially improve protection against future events, according to a multicenter review of 22 patients.
During the 2 years prior to undergoing left atrial appendage (LAA) occlusion, the 22 atrial fibrillation (AF) patients studied had a total of 44 cardioembolic events despite receiving “optimal” treatment with an oral anticoagulant, including nine patients with one event, six patients with two events, five patients with three events, and two patients with four events each, Xavier Freixa, MD, said at the annual International AF Symposium. In contrast, during a median follow-up of 1.8 years after their procedure additional events occurred in just two patients – one with a stroke, the other with a transient ischemic attack, while the remaining 20 patients remained free of any additional events.
The analysis also revealed that the two patients who had cardioembolic events following their LAA occlusion had been withdrawn from oral anticoagulant treatment by their physicians, who had done this with a “false feeling of comfort,” said Dr. Freixa, an interventional cardiologist at the University Hospital Clinic of Barcelona. These two patients were among three patients maintained on dual-antiplatelet therapy rather than on an oral anticoagulant following LAA occlusion. The remaining 19 patients had remained on either warfarin, a novel oral anticoagulant, or both.
The study included patients from eight Spanish centers who underwent LAA occlusion during June 2009–June 2017, and included 14 with nonvalvular AF and 8 with valvular AF who had all undergone prior valve surgery. None of the 22 patients had a contraindication for treatment with an oral anticoagulant. They averaged about 69 years of age. Prior to their procedure, 18 had at least one stroke or transient ischemic attack, and the remaining 4 patients had at least one systemic embolism. Nineteen patients underwent occlusion with either an Amplatzer Cardiac Plug or Amplatzer Amulet device, two received a Watchman device, and one patient received a LAmbre device. All of the closure procedures were successful, with no complications.
“I think any device will do well for these patients as long as we occlude the LAA,” Dr. Freixa said.
[email protected]
On Twitter @mitchelzoler
SOURCE: Freixa X et al. AF Symposium 2018 Abstract 1821.
REPORTING FROM THE AF SYMPOSIUM 2018
Key clinical point:
Major finding: Two of 22 patients had a cardioembolic event after left atrial appendage occlusion.
Study details: Review of 22 patients at eight Spanish centers with atrial fibrillation and a history of cardioembolic events despite oral anticoagulation.
Disclosures: Dr. Freixa has been a proctor for Abbott Medical.
Source: Freixa X et al. AF Symposium 2018 Abstract 1821.
Hodgkin lymphoma survivors are at an increased risk of subsequent ER-negative breast cancer
Young women with primary Hodgkin lymphoma had an increased relative risk of estrogen receptor–positive breast cancer if they received radiotherapy and, irrespective of the type of treatment they got, an elevated risk of ER-negative breast cancer, based on results of a study based on patient records from 12 U.S. National Cancer Institute Surveillance, Epidemiology, and End Results registries.
Of 7,355 women diagnosed with primary Hodgkin lymphoma during 1973-2009 and aged 10-39 years, 377 patients subsequently were diagnosed with breast cancer at a mean age of 45 years; 57% of the cancers were ER positive, 34% were ER negative, and 9% had unknown/borderline ER status, Diana R. Withrow, PhD, and her colleagues from the radiation epidemiology branch, division of cancer epidemiology and genetics, National Cancer Institute reported in JAMA Oncology.
Survivors of Hodgkin lymphoma had a greater relative risk of ER-negative (standardized incidence ratio, 5.8; 95% confidence interval, 4.8-6.9) than ER-positive breast cancer (SIR, 3.1; 95% CI, 2.7-3.5; P less than .001 for the difference), the researchers wrote.
For ER-positive disease, the increased SIR was observed only among women who had received radiotherapy for their Hodgkin lymphoma (SIR, 3.9; 95% CI, 3.4-4.5). In this group, the SIR for ER-positive disease was lower in the chemotherapy than in the no/unknown chemotherapy group (P = .04), said the researchers.
The authors acknowledged that lack of information on patient risk factors such as family history, reproductive factors, and hormone therapy, as well as detailed treatment information such as radiotherapy dose, fields, specific chemotherapeutic agents, and subsequent therapy is a limitation of the current study. Further research, including comprehensive treatment records, will lead to a better understanding of the association between treatment and breast cancer subtype in these patients, the researchers concluded.
None of the study authors reported any conflicts of interest.
SOURCE: Withrow D et al. doi: 10.1001/jamaoncol.2017.4887.
Young women with primary Hodgkin lymphoma had an increased relative risk of estrogen receptor–positive breast cancer if they received radiotherapy and, irrespective of the type of treatment they got, an elevated risk of ER-negative breast cancer, based on results of a study based on patient records from 12 U.S. National Cancer Institute Surveillance, Epidemiology, and End Results registries.
Of 7,355 women diagnosed with primary Hodgkin lymphoma during 1973-2009 and aged 10-39 years, 377 patients subsequently were diagnosed with breast cancer at a mean age of 45 years; 57% of the cancers were ER positive, 34% were ER negative, and 9% had unknown/borderline ER status, Diana R. Withrow, PhD, and her colleagues from the radiation epidemiology branch, division of cancer epidemiology and genetics, National Cancer Institute reported in JAMA Oncology.
Survivors of Hodgkin lymphoma had a greater relative risk of ER-negative (standardized incidence ratio, 5.8; 95% confidence interval, 4.8-6.9) than ER-positive breast cancer (SIR, 3.1; 95% CI, 2.7-3.5; P less than .001 for the difference), the researchers wrote.
For ER-positive disease, the increased SIR was observed only among women who had received radiotherapy for their Hodgkin lymphoma (SIR, 3.9; 95% CI, 3.4-4.5). In this group, the SIR for ER-positive disease was lower in the chemotherapy than in the no/unknown chemotherapy group (P = .04), said the researchers.
The authors acknowledged that lack of information on patient risk factors such as family history, reproductive factors, and hormone therapy, as well as detailed treatment information such as radiotherapy dose, fields, specific chemotherapeutic agents, and subsequent therapy is a limitation of the current study. Further research, including comprehensive treatment records, will lead to a better understanding of the association between treatment and breast cancer subtype in these patients, the researchers concluded.
None of the study authors reported any conflicts of interest.
SOURCE: Withrow D et al. doi: 10.1001/jamaoncol.2017.4887.
Young women with primary Hodgkin lymphoma had an increased relative risk of estrogen receptor–positive breast cancer if they received radiotherapy and, irrespective of the type of treatment they got, an elevated risk of ER-negative breast cancer, based on results of a study based on patient records from 12 U.S. National Cancer Institute Surveillance, Epidemiology, and End Results registries.
Of 7,355 women diagnosed with primary Hodgkin lymphoma during 1973-2009 and aged 10-39 years, 377 patients subsequently were diagnosed with breast cancer at a mean age of 45 years; 57% of the cancers were ER positive, 34% were ER negative, and 9% had unknown/borderline ER status, Diana R. Withrow, PhD, and her colleagues from the radiation epidemiology branch, division of cancer epidemiology and genetics, National Cancer Institute reported in JAMA Oncology.
Survivors of Hodgkin lymphoma had a greater relative risk of ER-negative (standardized incidence ratio, 5.8; 95% confidence interval, 4.8-6.9) than ER-positive breast cancer (SIR, 3.1; 95% CI, 2.7-3.5; P less than .001 for the difference), the researchers wrote.
For ER-positive disease, the increased SIR was observed only among women who had received radiotherapy for their Hodgkin lymphoma (SIR, 3.9; 95% CI, 3.4-4.5). In this group, the SIR for ER-positive disease was lower in the chemotherapy than in the no/unknown chemotherapy group (P = .04), said the researchers.
The authors acknowledged that lack of information on patient risk factors such as family history, reproductive factors, and hormone therapy, as well as detailed treatment information such as radiotherapy dose, fields, specific chemotherapeutic agents, and subsequent therapy is a limitation of the current study. Further research, including comprehensive treatment records, will lead to a better understanding of the association between treatment and breast cancer subtype in these patients, the researchers concluded.
None of the study authors reported any conflicts of interest.
SOURCE: Withrow D et al. doi: 10.1001/jamaoncol.2017.4887.
FROM JAMA ONCOLOGY
Key clinical point: .
Major finding: Survivors of Hodgkin lymphoma had a greater relative risk of ER-negative (standardized incidence ratio, 5.8) than ER-positive breast cancer (SIR, 3.1).
Study details: 7,355 women diagnosed with first primary Hodgkin lymphoma during 1973-2009, who were aged 10-39 years, and reported to 12 U.S. National Cancer Institute SEER registries.
Disclosures: None reported.
Source: Withrow D et al. doi: 10.1001/jamaoncolo.2017.4887.
Is it time for health policy M&Ms?
What would happen if hospitalists began to incorporate health policy into morbidity and mortality (M&M) conferences? That was a question Chris Moriates, MD, explored in an entry for SHM’s The Hospital Leader blog1 and an idea that caused a minor stir on Twitter when he proposed it last summer.
In late July 2017, the U.S. Senate was debating a bill to repeal the Affordable Care Act, without a clear vision for replacing it. In response, physicians around the country took to Twitter to share their sentiments about repeal under the hashtag #DoctorsSpeakOut. In one such tweet, Dr. Moriates, assistant dean for health care value and an associate professor of internal medicine at Dell Medical School at the University of Texas, Austin, said this, in 140 characters: “We recently had idea: health policy M&M for residents to discuss adverse outcomes we see as result of lack of access.”
The idea began with a conversation Dr. Moriates had with Beth Miller, MD, program director for the Dell Medical School Internal Medicine Residency Program. “We were meeting and talking about revamping the [resident] M&M conference to have more learning objectives and put in place best practices,” Dr. Moriates said. “Dr. Miller suggested it could be a good forum [for health policy] because it’s an area where we all come together and there’s a natural hook to it, since it is case-based, thus we can use it to recognize the drivers within the system that lead to bad outcomes.”
In his SHM blog post, Dr. Moriates said he has increasingly observed adverse events that result from issues related to health policy. He provided an example: “A patient I admitted for ‘expedited work-up’ for rectal bleeding after he told me he had been trying to get a recommended colonoscopy for many months but could not get it scheduled due to his lack of insurance. He had colon cancer that had spread.”
In another example, he conjured a hypothetical (though not impractical) case where a patient prescribed blood thinners upon hospital discharge returns to the hospital soon after with a blood clot. Unable to afford the medication, or seek primary care follow-up, this kind of patient is readmitted through no direct fault of his physicians. Yet, the patient is worse off and the hospital takes the hit on readmissions penalties.
Dr. Moriates believes that viewing a case like this through a health policy lens is not only moving, but critical to better understanding health care delivery, particularly in an environment where physician performance is measured, in part, by outcomes. He now believes health policy M&Ms would be valuable to all hospital-based physicians, not just residents.
“Hospitalists are being asked to hit these value-based performance metrics, like readmissions and length of stay, and while we deal with the consequences, we are not always the best informed” with respect to policy, he said. “We could use this forum to teach health policy topics and continually update people and contribute, in real time, to all these different discussions and understand how things are changing or could change and impact our patients.”
“It’s important for physicians to know the policies that are aligned with, and the policies that may undermine, what they’re doing in their practice to improve their patients’ health,” Pourat said.
This knowledge can benefit physicians, too, Pourat added, because health policy M&Ms could help providers understand the goals of particular policies and in turn adjust their own behaviors and expectations.
“Physicians could discuss, what are the underlying issues or root causes, like the decision not to expand Medicaid here in Texas,” Dr. Moriates said. “Not all of these things you can fix, but you’re exposing those stories and perhaps we can come up with some actionable steps. How do we ensure in the future that our patients are able to fulfill their prescription so we’re not just sending someone out assuming they will but not knowing they’re unable to afford it?”
Similar to other domains in which physician leaders become champions, such as antibiotic stewardship, Dr. Pourat suggested that hospitalists could champion policy awareness through the kind of M&Ms Dr. Moriates proposed.
While journal clubs and lectures are great ways for hospitalists to learn more about health policy, the emotionally gripping nature of M&Ms could inspire more physicians to act in favor of policies that benefit their patients and themselves, Dr. Moriates said.
For example, physicians may write to or visit legislative offices, or author op-eds in their local newspapers. This collective action carries the potential to effect change. And it need not be partisan.
“I believe that if health policy issues were more explicitly integrated into M&Ms then clinicians would be more inclined and prepared to effectively advocate for specific policy changes,” he wrote in his blog post. “Perhaps entire groups would be moved to engage in the political process.”
On Twitter, even before Dr. Moriates’ first tweet about health policy M&Ms, New Jersey–based Jennifer Chuang, MD, an adolescent medicine physician, wrote: “M&M is heart-wrenching in academic hospitals. I dare @SenateGOP to present their role in M&M’s to come if ACA is repealed.”
While Dr. Moriates believes the chances are quite small that legislators and policymakers would attend health policy M&Ms, he called the notion “provocative and intriguing.”
In his blog post, Dr. Moriates invites state legislators and local members of Congress to join him in reviewing M&M cases where patients have been negatively affected by policy. He also emphasized that, like most modern M&Ms, the point should not be derision or finger-pointing, but an opportunity to learn how policy translates into practice.
Physicians may learn from legislators, too, he said in his blog post. “Just as policymakers could see legislation through the eyes of practitioners and their patients, this is where we as physicians could possibly learn from our legislators,” he wrote. “We may recognize the potential trade-offs, downsides, and barriers to proposals that to us may have seemed like no-brainers.”
What’s clear, said Dr. Pourat, who is also a professor in the UCLA Fielding School of Public Health and the School of Dentistry, is that Dr. Moriates’ blog post and tweet are “touching an important point for a lot of physicians during this whole debate over health reform.”
President Donald Trump campaigned on a promise to fully repeal and replace the Affordable Care Act but Republican efforts have thus far been stymied. In the meantime, some physicians are watching closely, knowing that whatever comes next will continue to affect them and their patients.
Source
1. Moriates C. Is it time for health policy M&Ms? The Hospital Leader. Aug 16, 2017. http://thehospitalleader.org/is-it-time-for-health-policy-mms/. Accessed 2017 Sep 14.
What would happen if hospitalists began to incorporate health policy into morbidity and mortality (M&M) conferences? That was a question Chris Moriates, MD, explored in an entry for SHM’s The Hospital Leader blog1 and an idea that caused a minor stir on Twitter when he proposed it last summer.
In late July 2017, the U.S. Senate was debating a bill to repeal the Affordable Care Act, without a clear vision for replacing it. In response, physicians around the country took to Twitter to share their sentiments about repeal under the hashtag #DoctorsSpeakOut. In one such tweet, Dr. Moriates, assistant dean for health care value and an associate professor of internal medicine at Dell Medical School at the University of Texas, Austin, said this, in 140 characters: “We recently had idea: health policy M&M for residents to discuss adverse outcomes we see as result of lack of access.”
The idea began with a conversation Dr. Moriates had with Beth Miller, MD, program director for the Dell Medical School Internal Medicine Residency Program. “We were meeting and talking about revamping the [resident] M&M conference to have more learning objectives and put in place best practices,” Dr. Moriates said. “Dr. Miller suggested it could be a good forum [for health policy] because it’s an area where we all come together and there’s a natural hook to it, since it is case-based, thus we can use it to recognize the drivers within the system that lead to bad outcomes.”
In his SHM blog post, Dr. Moriates said he has increasingly observed adverse events that result from issues related to health policy. He provided an example: “A patient I admitted for ‘expedited work-up’ for rectal bleeding after he told me he had been trying to get a recommended colonoscopy for many months but could not get it scheduled due to his lack of insurance. He had colon cancer that had spread.”
In another example, he conjured a hypothetical (though not impractical) case where a patient prescribed blood thinners upon hospital discharge returns to the hospital soon after with a blood clot. Unable to afford the medication, or seek primary care follow-up, this kind of patient is readmitted through no direct fault of his physicians. Yet, the patient is worse off and the hospital takes the hit on readmissions penalties.
Dr. Moriates believes that viewing a case like this through a health policy lens is not only moving, but critical to better understanding health care delivery, particularly in an environment where physician performance is measured, in part, by outcomes. He now believes health policy M&Ms would be valuable to all hospital-based physicians, not just residents.
“Hospitalists are being asked to hit these value-based performance metrics, like readmissions and length of stay, and while we deal with the consequences, we are not always the best informed” with respect to policy, he said. “We could use this forum to teach health policy topics and continually update people and contribute, in real time, to all these different discussions and understand how things are changing or could change and impact our patients.”
“It’s important for physicians to know the policies that are aligned with, and the policies that may undermine, what they’re doing in their practice to improve their patients’ health,” Pourat said.
This knowledge can benefit physicians, too, Pourat added, because health policy M&Ms could help providers understand the goals of particular policies and in turn adjust their own behaviors and expectations.
“Physicians could discuss, what are the underlying issues or root causes, like the decision not to expand Medicaid here in Texas,” Dr. Moriates said. “Not all of these things you can fix, but you’re exposing those stories and perhaps we can come up with some actionable steps. How do we ensure in the future that our patients are able to fulfill their prescription so we’re not just sending someone out assuming they will but not knowing they’re unable to afford it?”
Similar to other domains in which physician leaders become champions, such as antibiotic stewardship, Dr. Pourat suggested that hospitalists could champion policy awareness through the kind of M&Ms Dr. Moriates proposed.
While journal clubs and lectures are great ways for hospitalists to learn more about health policy, the emotionally gripping nature of M&Ms could inspire more physicians to act in favor of policies that benefit their patients and themselves, Dr. Moriates said.
For example, physicians may write to or visit legislative offices, or author op-eds in their local newspapers. This collective action carries the potential to effect change. And it need not be partisan.
“I believe that if health policy issues were more explicitly integrated into M&Ms then clinicians would be more inclined and prepared to effectively advocate for specific policy changes,” he wrote in his blog post. “Perhaps entire groups would be moved to engage in the political process.”
On Twitter, even before Dr. Moriates’ first tweet about health policy M&Ms, New Jersey–based Jennifer Chuang, MD, an adolescent medicine physician, wrote: “M&M is heart-wrenching in academic hospitals. I dare @SenateGOP to present their role in M&M’s to come if ACA is repealed.”
While Dr. Moriates believes the chances are quite small that legislators and policymakers would attend health policy M&Ms, he called the notion “provocative and intriguing.”
In his blog post, Dr. Moriates invites state legislators and local members of Congress to join him in reviewing M&M cases where patients have been negatively affected by policy. He also emphasized that, like most modern M&Ms, the point should not be derision or finger-pointing, but an opportunity to learn how policy translates into practice.
Physicians may learn from legislators, too, he said in his blog post. “Just as policymakers could see legislation through the eyes of practitioners and their patients, this is where we as physicians could possibly learn from our legislators,” he wrote. “We may recognize the potential trade-offs, downsides, and barriers to proposals that to us may have seemed like no-brainers.”
What’s clear, said Dr. Pourat, who is also a professor in the UCLA Fielding School of Public Health and the School of Dentistry, is that Dr. Moriates’ blog post and tweet are “touching an important point for a lot of physicians during this whole debate over health reform.”
President Donald Trump campaigned on a promise to fully repeal and replace the Affordable Care Act but Republican efforts have thus far been stymied. In the meantime, some physicians are watching closely, knowing that whatever comes next will continue to affect them and their patients.
Source
1. Moriates C. Is it time for health policy M&Ms? The Hospital Leader. Aug 16, 2017. http://thehospitalleader.org/is-it-time-for-health-policy-mms/. Accessed 2017 Sep 14.
What would happen if hospitalists began to incorporate health policy into morbidity and mortality (M&M) conferences? That was a question Chris Moriates, MD, explored in an entry for SHM’s The Hospital Leader blog1 and an idea that caused a minor stir on Twitter when he proposed it last summer.
In late July 2017, the U.S. Senate was debating a bill to repeal the Affordable Care Act, without a clear vision for replacing it. In response, physicians around the country took to Twitter to share their sentiments about repeal under the hashtag #DoctorsSpeakOut. In one such tweet, Dr. Moriates, assistant dean for health care value and an associate professor of internal medicine at Dell Medical School at the University of Texas, Austin, said this, in 140 characters: “We recently had idea: health policy M&M for residents to discuss adverse outcomes we see as result of lack of access.”
The idea began with a conversation Dr. Moriates had with Beth Miller, MD, program director for the Dell Medical School Internal Medicine Residency Program. “We were meeting and talking about revamping the [resident] M&M conference to have more learning objectives and put in place best practices,” Dr. Moriates said. “Dr. Miller suggested it could be a good forum [for health policy] because it’s an area where we all come together and there’s a natural hook to it, since it is case-based, thus we can use it to recognize the drivers within the system that lead to bad outcomes.”
In his SHM blog post, Dr. Moriates said he has increasingly observed adverse events that result from issues related to health policy. He provided an example: “A patient I admitted for ‘expedited work-up’ for rectal bleeding after he told me he had been trying to get a recommended colonoscopy for many months but could not get it scheduled due to his lack of insurance. He had colon cancer that had spread.”
In another example, he conjured a hypothetical (though not impractical) case where a patient prescribed blood thinners upon hospital discharge returns to the hospital soon after with a blood clot. Unable to afford the medication, or seek primary care follow-up, this kind of patient is readmitted through no direct fault of his physicians. Yet, the patient is worse off and the hospital takes the hit on readmissions penalties.
Dr. Moriates believes that viewing a case like this through a health policy lens is not only moving, but critical to better understanding health care delivery, particularly in an environment where physician performance is measured, in part, by outcomes. He now believes health policy M&Ms would be valuable to all hospital-based physicians, not just residents.
“Hospitalists are being asked to hit these value-based performance metrics, like readmissions and length of stay, and while we deal with the consequences, we are not always the best informed” with respect to policy, he said. “We could use this forum to teach health policy topics and continually update people and contribute, in real time, to all these different discussions and understand how things are changing or could change and impact our patients.”
“It’s important for physicians to know the policies that are aligned with, and the policies that may undermine, what they’re doing in their practice to improve their patients’ health,” Pourat said.
This knowledge can benefit physicians, too, Pourat added, because health policy M&Ms could help providers understand the goals of particular policies and in turn adjust their own behaviors and expectations.
“Physicians could discuss, what are the underlying issues or root causes, like the decision not to expand Medicaid here in Texas,” Dr. Moriates said. “Not all of these things you can fix, but you’re exposing those stories and perhaps we can come up with some actionable steps. How do we ensure in the future that our patients are able to fulfill their prescription so we’re not just sending someone out assuming they will but not knowing they’re unable to afford it?”
Similar to other domains in which physician leaders become champions, such as antibiotic stewardship, Dr. Pourat suggested that hospitalists could champion policy awareness through the kind of M&Ms Dr. Moriates proposed.
While journal clubs and lectures are great ways for hospitalists to learn more about health policy, the emotionally gripping nature of M&Ms could inspire more physicians to act in favor of policies that benefit their patients and themselves, Dr. Moriates said.
For example, physicians may write to or visit legislative offices, or author op-eds in their local newspapers. This collective action carries the potential to effect change. And it need not be partisan.
“I believe that if health policy issues were more explicitly integrated into M&Ms then clinicians would be more inclined and prepared to effectively advocate for specific policy changes,” he wrote in his blog post. “Perhaps entire groups would be moved to engage in the political process.”
On Twitter, even before Dr. Moriates’ first tweet about health policy M&Ms, New Jersey–based Jennifer Chuang, MD, an adolescent medicine physician, wrote: “M&M is heart-wrenching in academic hospitals. I dare @SenateGOP to present their role in M&M’s to come if ACA is repealed.”
While Dr. Moriates believes the chances are quite small that legislators and policymakers would attend health policy M&Ms, he called the notion “provocative and intriguing.”
In his blog post, Dr. Moriates invites state legislators and local members of Congress to join him in reviewing M&M cases where patients have been negatively affected by policy. He also emphasized that, like most modern M&Ms, the point should not be derision or finger-pointing, but an opportunity to learn how policy translates into practice.
Physicians may learn from legislators, too, he said in his blog post. “Just as policymakers could see legislation through the eyes of practitioners and their patients, this is where we as physicians could possibly learn from our legislators,” he wrote. “We may recognize the potential trade-offs, downsides, and barriers to proposals that to us may have seemed like no-brainers.”
What’s clear, said Dr. Pourat, who is also a professor in the UCLA Fielding School of Public Health and the School of Dentistry, is that Dr. Moriates’ blog post and tweet are “touching an important point for a lot of physicians during this whole debate over health reform.”
President Donald Trump campaigned on a promise to fully repeal and replace the Affordable Care Act but Republican efforts have thus far been stymied. In the meantime, some physicians are watching closely, knowing that whatever comes next will continue to affect them and their patients.
Source
1. Moriates C. Is it time for health policy M&Ms? The Hospital Leader. Aug 16, 2017. http://thehospitalleader.org/is-it-time-for-health-policy-mms/. Accessed 2017 Sep 14.
Stroke Risk: Estrogen Use in Women with Migraine
The results of a recent study are consistent with an additive increase in stroke risk with combined hormonal contraceptives (CHC) use in women who have migraine with aura. Since the absolute risk of stroke is low even in the presence of these risk factors, use of CHCs in women who have migraine with aura should be based on an individualized assessment of harms and benefits. Researchers conducted a literature search of PubMed, the Cochrane Library, and EMBASE from inception through January 2016 for relevant studies. They included studies that examined exposure to CHCs and reported outcomes of ischemic or hemorrhagic stroke. They found:
- Of 2480 records, 15 studies met inclusion criteria.
- No studies reported odds ratios for stroke risk as a function of estrogen dose in women with migraine, largely due to insufficient sample sizes.
- No interaction effect between migraine and CHCs was seen in the 7 studies that assessed this.
- One study differentiated risk by presence or absence of migraine aura and found an increased risk in the migraine with aura population.
Risk of stroke associated with use of estrogen containing contraceptives in women with migraine: A systematic review. [Published online ahead of print November 15, 2017]. Headache. doi:10.1111/head.13229.
The results of a recent study are consistent with an additive increase in stroke risk with combined hormonal contraceptives (CHC) use in women who have migraine with aura. Since the absolute risk of stroke is low even in the presence of these risk factors, use of CHCs in women who have migraine with aura should be based on an individualized assessment of harms and benefits. Researchers conducted a literature search of PubMed, the Cochrane Library, and EMBASE from inception through January 2016 for relevant studies. They included studies that examined exposure to CHCs and reported outcomes of ischemic or hemorrhagic stroke. They found:
- Of 2480 records, 15 studies met inclusion criteria.
- No studies reported odds ratios for stroke risk as a function of estrogen dose in women with migraine, largely due to insufficient sample sizes.
- No interaction effect between migraine and CHCs was seen in the 7 studies that assessed this.
- One study differentiated risk by presence or absence of migraine aura and found an increased risk in the migraine with aura population.
Risk of stroke associated with use of estrogen containing contraceptives in women with migraine: A systematic review. [Published online ahead of print November 15, 2017]. Headache. doi:10.1111/head.13229.
The results of a recent study are consistent with an additive increase in stroke risk with combined hormonal contraceptives (CHC) use in women who have migraine with aura. Since the absolute risk of stroke is low even in the presence of these risk factors, use of CHCs in women who have migraine with aura should be based on an individualized assessment of harms and benefits. Researchers conducted a literature search of PubMed, the Cochrane Library, and EMBASE from inception through January 2016 for relevant studies. They included studies that examined exposure to CHCs and reported outcomes of ischemic or hemorrhagic stroke. They found:
- Of 2480 records, 15 studies met inclusion criteria.
- No studies reported odds ratios for stroke risk as a function of estrogen dose in women with migraine, largely due to insufficient sample sizes.
- No interaction effect between migraine and CHCs was seen in the 7 studies that assessed this.
- One study differentiated risk by presence or absence of migraine aura and found an increased risk in the migraine with aura population.
Risk of stroke associated with use of estrogen containing contraceptives in women with migraine: A systematic review. [Published online ahead of print November 15, 2017]. Headache. doi:10.1111/head.13229.
Senate votes on 20-week abortion ban
The U.S. Senate blocked a proposed national ban on abortions after 20 weeks gestation following a closely divided 51-46 vote on Jan. 29.
The Pain-Capable Unborn Children Protection Act, which passed the House last year after a 237-189 vote, did not earn the 60 votes it needed to clear the Senate, marking a defeat for anti-abortion proponents such as Senate Majority Leader Mitch McConnell (R-Ky.).
In a Jan. 29 statement, Sen. McConnell said the Pain-Capable Unborn Child Protection Act reflects a growing consensus that unborn children should not be subjected to elective abortion after 20 weeks.
After the vote, President Trump said in a statement that it was “disappointing that despite support from a bipartisan majority of U.S. Senators, this bill was blocked from further consideration.”
The American College of Obstetricians and Gynecologists (ACOG) denounced the legislation in a Jan. 26 statement, calling it an attack on women’s access to comprehensive health care, including abortion care.
The vote was primarily split along party lines. Only three Democrats voted for the bill – Sens. Robert P. Casey Jr. of Pennsylvania, Joe Donnelly of Indiana, and Joe Manchin III of West Virginia. The three are all up for reelection this year in states in which Trump won in 2016.
The U.S. Senate blocked a proposed national ban on abortions after 20 weeks gestation following a closely divided 51-46 vote on Jan. 29.
The Pain-Capable Unborn Children Protection Act, which passed the House last year after a 237-189 vote, did not earn the 60 votes it needed to clear the Senate, marking a defeat for anti-abortion proponents such as Senate Majority Leader Mitch McConnell (R-Ky.).
In a Jan. 29 statement, Sen. McConnell said the Pain-Capable Unborn Child Protection Act reflects a growing consensus that unborn children should not be subjected to elective abortion after 20 weeks.
After the vote, President Trump said in a statement that it was “disappointing that despite support from a bipartisan majority of U.S. Senators, this bill was blocked from further consideration.”
The American College of Obstetricians and Gynecologists (ACOG) denounced the legislation in a Jan. 26 statement, calling it an attack on women’s access to comprehensive health care, including abortion care.
The vote was primarily split along party lines. Only three Democrats voted for the bill – Sens. Robert P. Casey Jr. of Pennsylvania, Joe Donnelly of Indiana, and Joe Manchin III of West Virginia. The three are all up for reelection this year in states in which Trump won in 2016.
The U.S. Senate blocked a proposed national ban on abortions after 20 weeks gestation following a closely divided 51-46 vote on Jan. 29.
The Pain-Capable Unborn Children Protection Act, which passed the House last year after a 237-189 vote, did not earn the 60 votes it needed to clear the Senate, marking a defeat for anti-abortion proponents such as Senate Majority Leader Mitch McConnell (R-Ky.).
In a Jan. 29 statement, Sen. McConnell said the Pain-Capable Unborn Child Protection Act reflects a growing consensus that unborn children should not be subjected to elective abortion after 20 weeks.
After the vote, President Trump said in a statement that it was “disappointing that despite support from a bipartisan majority of U.S. Senators, this bill was blocked from further consideration.”
The American College of Obstetricians and Gynecologists (ACOG) denounced the legislation in a Jan. 26 statement, calling it an attack on women’s access to comprehensive health care, including abortion care.
The vote was primarily split along party lines. Only three Democrats voted for the bill – Sens. Robert P. Casey Jr. of Pennsylvania, Joe Donnelly of Indiana, and Joe Manchin III of West Virginia. The three are all up for reelection this year in states in which Trump won in 2016.
Does hormonal contraception increase the risk of breast cancer?
Hormonal contraception (HC) has long been utilized safely in this country for a variety of indications, including pregnancy prevention, timing pregnancy appropriately, management of symptoms (dysmenorrhea, irregular menstrual cycles, heavy menstrual bleeding), and to prevent serious diseases (such as ovarian cancer, uterine cancer, osteoporosis in women with premature menopause). Like most prescription medications, there are potential adverse effects. With HC, side effects such as venous thromboembolism, a slight increase in liver cancer, and a possible increase in breast cancer risk have long been recognized.
Danish study compared HC use with breast cancer risk
In the December 7, 2017, issue of New England Journal of Medicine,1 investigators in Denmark published a study of women using HC (oral, transdermal, intravaginal routes, and levonorgestrel intrauterine device [LNG-IUD]) and breast cancer risk compared with women who did not use HC. This retrospective observational country-wide study was very large (1.8 million women followed over an average of 10.9 years), which allowed for the detection of even small changes in breast cancer risk.
Putting results in perspective
It is important to point out that this is an observational study, and small effect sizes (1 in 7,600) should be interpreted with caution. Observational studies can introduce many different types of bias (prescribing bias, confounding bias, etc). Of note, while the LNG-IUD was associated with a small increased risk of breast cancer (relative risk [RR], 1.21; 95% confidence interval [CI], 1.11-1.33]), the higher dose continuous progestin administration (medroxyprogesterone) was not (RR, 0.95; 95% CI, 0.40-2.29).1
Nonetheless, providing patients with a balanced summary of this new study along with other published and reliable information about HC that conveys both benefits and risks is important to assure that each woman makes a decision regarding HC that achieves her health and life goals. See "Counseling talking points" below.
Bottom line
This recent study demonstrated that in Denmark, a woman's risk of developing breast cancer is very slightly elevated on HC1:
- 1 in 7,690 users overall
- 1 in 50,000 women older than age 35 years.
By comparison, the risk of maternal mortality in the United States is 1 in 3,788.2 A substantial reduction in HC use would likely increase unintended and mistimed pregnancies with a potential substantial negative impact on quality of life and personal/societal cost.
The best available data indicate that a woman's risk of developing any cancer is slightly less on HC than not on HC, even with this incremental breast cancer increase.3,4
Breast cancer risk relative to benefits of pregnancy prevention
There was a very slight increase in breast cancer in women using HC in the Danish study.1
Risk of breast cancer
- Overall, the number needed to harm (NNH) was approximately 1 in 7,690, which equates to 13 incremental breast cancers for every 100,000 women using HC (0.013%).
- Breast cancer risk was not evenly distributed across the different age groups. In women younger than 35 years, the risk was 1 extra case for every 50,000 women using HC (0.002%).
Risk of pregnancy prevention failure: Maternal mortality
- By comparison, the rate of maternal mortality is considerably higher than either of these risks in the United States. Specifically, the most recently available rate of maternal mortality (2015) in the United States was 26.4 for every 100,000 women, essentially double that of developing breast cancer on HC.2
-- Most women who develop breast cancer while on HC will survive their cancer long-term.5 And most would agree that while neither is desirable, death is a worse outcome than the development of breast cancer.
Risk of pregnancy prevention failure other than maternal mortality
- Other than the copper IUD and sterilization methods, all other nonhormonal contraceptive methods are by far inferior in terms of the ability to prevent unintended pregnancy.
- Unintended pregnancy has substantial health, social, and economic consequences to women and infants, and contraception use is a well-accepted proximate determinant of unintended pregnancy.6
- Unintended pregnancy is a serious maternal-child health problem with potentially long-term burdens not only for women and families7-10 but also for society.11-13
- Unintended pregnancies generate an estimated $21 billion direct and indirect costs for the US health care system per year,14 and approximately 42% of these pregnancies end in abortion.15
HC cancer risk and HC cancer prevention
- HC use increases risk of breast and liver cancer but reduces risk of ovarian, endometrial, and colorectal cancer; the net effect is a modest reduction in total cancer.3,4
- In addition, there appears to be additional cervical cancer prevention benefit from IUD use.16
- In a recent meta-analysis, IUDs (including LNG-IUD) have been associated with a 33% reduction in cervical cancer.16
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Mørch, LS, Skovlund CW, Hannaford PC, et al. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228-2239.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775-1812.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193-200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276-2277.
- American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta, Georgia: American Cancer Society, Inc; 2015.
- Sonfield A. What the Agency for Healthcare Research and Quality forgets to tell Americans about how to protect their sexual and reproductive health. Womens Health Issues. 2015;25(1):1-2.
- Brown SS, Eisenberg L. The best intentions: Unintended pregnancy and the wellbeing of children and families. Washington, DC: National Academy Press; 1995:50-90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281-286.
- Logan C, Holcombe E, Manlove J, Ryan S. The consequences of unintended childbearing. The National Campaign to Prevent Teen Pregnancy and Child Trends. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf. Published May 2007. Accessed January 11, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126-127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154-161.
- Sonfield A, Kost K. Public costs from unintended pregnancy and the role of public insurance program in paying for pregnancy and infant care: Estimates for 2008. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP.pdf. Published October 2013. Accessed January 15, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6-15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: National and state estimates for 2010. Guttmacher Institute; 2015. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Accessed January 29, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med. 2016;374(9):843-852.
- Cortessis VK, Barrett M, Brown Wade N, et al. Intrauterine device use and cervical cancer risk: A systematic review and meta-analysis. Obstet Gynecol. 2017;130(6):1226-1236.
Dr. Scott is a Fellow in the Cancer Genetics and Breast Health Department of Obstetrics and Gynecology University of Michigan Medical School, Ann Arbor
Dr. Pearlman is S. Jan Behrman Professor and Interim Chair, Director, Fellowship in Breast Health and Cancer Genetics, Department of Obstetrics and Gynecology, Michigan Medicine (University of Michigan), Ann Arbor, Michigan.
The authors reports no financial relationships relevant to this article.
Dr. Scott is a Fellow in the Cancer Genetics and Breast Health Department of Obstetrics and Gynecology University of Michigan Medical School, Ann Arbor
Dr. Pearlman is S. Jan Behrman Professor and Interim Chair, Director, Fellowship in Breast Health and Cancer Genetics, Department of Obstetrics and Gynecology, Michigan Medicine (University of Michigan), Ann Arbor, Michigan.
The authors reports no financial relationships relevant to this article.
Dr. Scott is a Fellow in the Cancer Genetics and Breast Health Department of Obstetrics and Gynecology University of Michigan Medical School, Ann Arbor
Dr. Pearlman is S. Jan Behrman Professor and Interim Chair, Director, Fellowship in Breast Health and Cancer Genetics, Department of Obstetrics and Gynecology, Michigan Medicine (University of Michigan), Ann Arbor, Michigan.
The authors reports no financial relationships relevant to this article.
Hormonal contraception (HC) has long been utilized safely in this country for a variety of indications, including pregnancy prevention, timing pregnancy appropriately, management of symptoms (dysmenorrhea, irregular menstrual cycles, heavy menstrual bleeding), and to prevent serious diseases (such as ovarian cancer, uterine cancer, osteoporosis in women with premature menopause). Like most prescription medications, there are potential adverse effects. With HC, side effects such as venous thromboembolism, a slight increase in liver cancer, and a possible increase in breast cancer risk have long been recognized.
Danish study compared HC use with breast cancer risk
In the December 7, 2017, issue of New England Journal of Medicine,1 investigators in Denmark published a study of women using HC (oral, transdermal, intravaginal routes, and levonorgestrel intrauterine device [LNG-IUD]) and breast cancer risk compared with women who did not use HC. This retrospective observational country-wide study was very large (1.8 million women followed over an average of 10.9 years), which allowed for the detection of even small changes in breast cancer risk.
Putting results in perspective
It is important to point out that this is an observational study, and small effect sizes (1 in 7,600) should be interpreted with caution. Observational studies can introduce many different types of bias (prescribing bias, confounding bias, etc). Of note, while the LNG-IUD was associated with a small increased risk of breast cancer (relative risk [RR], 1.21; 95% confidence interval [CI], 1.11-1.33]), the higher dose continuous progestin administration (medroxyprogesterone) was not (RR, 0.95; 95% CI, 0.40-2.29).1
Nonetheless, providing patients with a balanced summary of this new study along with other published and reliable information about HC that conveys both benefits and risks is important to assure that each woman makes a decision regarding HC that achieves her health and life goals. See "Counseling talking points" below.
Bottom line
This recent study demonstrated that in Denmark, a woman's risk of developing breast cancer is very slightly elevated on HC1:
- 1 in 7,690 users overall
- 1 in 50,000 women older than age 35 years.
By comparison, the risk of maternal mortality in the United States is 1 in 3,788.2 A substantial reduction in HC use would likely increase unintended and mistimed pregnancies with a potential substantial negative impact on quality of life and personal/societal cost.
The best available data indicate that a woman's risk of developing any cancer is slightly less on HC than not on HC, even with this incremental breast cancer increase.3,4
Breast cancer risk relative to benefits of pregnancy prevention
There was a very slight increase in breast cancer in women using HC in the Danish study.1
Risk of breast cancer
- Overall, the number needed to harm (NNH) was approximately 1 in 7,690, which equates to 13 incremental breast cancers for every 100,000 women using HC (0.013%).
- Breast cancer risk was not evenly distributed across the different age groups. In women younger than 35 years, the risk was 1 extra case for every 50,000 women using HC (0.002%).
Risk of pregnancy prevention failure: Maternal mortality
- By comparison, the rate of maternal mortality is considerably higher than either of these risks in the United States. Specifically, the most recently available rate of maternal mortality (2015) in the United States was 26.4 for every 100,000 women, essentially double that of developing breast cancer on HC.2
-- Most women who develop breast cancer while on HC will survive their cancer long-term.5 And most would agree that while neither is desirable, death is a worse outcome than the development of breast cancer.
Risk of pregnancy prevention failure other than maternal mortality
- Other than the copper IUD and sterilization methods, all other nonhormonal contraceptive methods are by far inferior in terms of the ability to prevent unintended pregnancy.
- Unintended pregnancy has substantial health, social, and economic consequences to women and infants, and contraception use is a well-accepted proximate determinant of unintended pregnancy.6
- Unintended pregnancy is a serious maternal-child health problem with potentially long-term burdens not only for women and families7-10 but also for society.11-13
- Unintended pregnancies generate an estimated $21 billion direct and indirect costs for the US health care system per year,14 and approximately 42% of these pregnancies end in abortion.15
HC cancer risk and HC cancer prevention
- HC use increases risk of breast and liver cancer but reduces risk of ovarian, endometrial, and colorectal cancer; the net effect is a modest reduction in total cancer.3,4
- In addition, there appears to be additional cervical cancer prevention benefit from IUD use.16
- In a recent meta-analysis, IUDs (including LNG-IUD) have been associated with a 33% reduction in cervical cancer.16
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Hormonal contraception (HC) has long been utilized safely in this country for a variety of indications, including pregnancy prevention, timing pregnancy appropriately, management of symptoms (dysmenorrhea, irregular menstrual cycles, heavy menstrual bleeding), and to prevent serious diseases (such as ovarian cancer, uterine cancer, osteoporosis in women with premature menopause). Like most prescription medications, there are potential adverse effects. With HC, side effects such as venous thromboembolism, a slight increase in liver cancer, and a possible increase in breast cancer risk have long been recognized.
Danish study compared HC use with breast cancer risk
In the December 7, 2017, issue of New England Journal of Medicine,1 investigators in Denmark published a study of women using HC (oral, transdermal, intravaginal routes, and levonorgestrel intrauterine device [LNG-IUD]) and breast cancer risk compared with women who did not use HC. This retrospective observational country-wide study was very large (1.8 million women followed over an average of 10.9 years), which allowed for the detection of even small changes in breast cancer risk.
Putting results in perspective
It is important to point out that this is an observational study, and small effect sizes (1 in 7,600) should be interpreted with caution. Observational studies can introduce many different types of bias (prescribing bias, confounding bias, etc). Of note, while the LNG-IUD was associated with a small increased risk of breast cancer (relative risk [RR], 1.21; 95% confidence interval [CI], 1.11-1.33]), the higher dose continuous progestin administration (medroxyprogesterone) was not (RR, 0.95; 95% CI, 0.40-2.29).1
Nonetheless, providing patients with a balanced summary of this new study along with other published and reliable information about HC that conveys both benefits and risks is important to assure that each woman makes a decision regarding HC that achieves her health and life goals. See "Counseling talking points" below.
Bottom line
This recent study demonstrated that in Denmark, a woman's risk of developing breast cancer is very slightly elevated on HC1:
- 1 in 7,690 users overall
- 1 in 50,000 women older than age 35 years.
By comparison, the risk of maternal mortality in the United States is 1 in 3,788.2 A substantial reduction in HC use would likely increase unintended and mistimed pregnancies with a potential substantial negative impact on quality of life and personal/societal cost.
The best available data indicate that a woman's risk of developing any cancer is slightly less on HC than not on HC, even with this incremental breast cancer increase.3,4
Breast cancer risk relative to benefits of pregnancy prevention
There was a very slight increase in breast cancer in women using HC in the Danish study.1
Risk of breast cancer
- Overall, the number needed to harm (NNH) was approximately 1 in 7,690, which equates to 13 incremental breast cancers for every 100,000 women using HC (0.013%).
- Breast cancer risk was not evenly distributed across the different age groups. In women younger than 35 years, the risk was 1 extra case for every 50,000 women using HC (0.002%).
Risk of pregnancy prevention failure: Maternal mortality
- By comparison, the rate of maternal mortality is considerably higher than either of these risks in the United States. Specifically, the most recently available rate of maternal mortality (2015) in the United States was 26.4 for every 100,000 women, essentially double that of developing breast cancer on HC.2
-- Most women who develop breast cancer while on HC will survive their cancer long-term.5 And most would agree that while neither is desirable, death is a worse outcome than the development of breast cancer.
Risk of pregnancy prevention failure other than maternal mortality
- Other than the copper IUD and sterilization methods, all other nonhormonal contraceptive methods are by far inferior in terms of the ability to prevent unintended pregnancy.
- Unintended pregnancy has substantial health, social, and economic consequences to women and infants, and contraception use is a well-accepted proximate determinant of unintended pregnancy.6
- Unintended pregnancy is a serious maternal-child health problem with potentially long-term burdens not only for women and families7-10 but also for society.11-13
- Unintended pregnancies generate an estimated $21 billion direct and indirect costs for the US health care system per year,14 and approximately 42% of these pregnancies end in abortion.15
HC cancer risk and HC cancer prevention
- HC use increases risk of breast and liver cancer but reduces risk of ovarian, endometrial, and colorectal cancer; the net effect is a modest reduction in total cancer.3,4
- In addition, there appears to be additional cervical cancer prevention benefit from IUD use.16
- In a recent meta-analysis, IUDs (including LNG-IUD) have been associated with a 33% reduction in cervical cancer.16
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Mørch, LS, Skovlund CW, Hannaford PC, et al. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228-2239.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775-1812.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193-200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276-2277.
- American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta, Georgia: American Cancer Society, Inc; 2015.
- Sonfield A. What the Agency for Healthcare Research and Quality forgets to tell Americans about how to protect their sexual and reproductive health. Womens Health Issues. 2015;25(1):1-2.
- Brown SS, Eisenberg L. The best intentions: Unintended pregnancy and the wellbeing of children and families. Washington, DC: National Academy Press; 1995:50-90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281-286.
- Logan C, Holcombe E, Manlove J, Ryan S. The consequences of unintended childbearing. The National Campaign to Prevent Teen Pregnancy and Child Trends. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf. Published May 2007. Accessed January 11, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126-127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154-161.
- Sonfield A, Kost K. Public costs from unintended pregnancy and the role of public insurance program in paying for pregnancy and infant care: Estimates for 2008. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP.pdf. Published October 2013. Accessed January 15, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6-15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: National and state estimates for 2010. Guttmacher Institute; 2015. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Accessed January 29, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med. 2016;374(9):843-852.
- Cortessis VK, Barrett M, Brown Wade N, et al. Intrauterine device use and cervical cancer risk: A systematic review and meta-analysis. Obstet Gynecol. 2017;130(6):1226-1236.
- Mørch, LS, Skovlund CW, Hannaford PC, et al. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228-2239.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775-1812.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193-200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276-2277.
- American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta, Georgia: American Cancer Society, Inc; 2015.
- Sonfield A. What the Agency for Healthcare Research and Quality forgets to tell Americans about how to protect their sexual and reproductive health. Womens Health Issues. 2015;25(1):1-2.
- Brown SS, Eisenberg L. The best intentions: Unintended pregnancy and the wellbeing of children and families. Washington, DC: National Academy Press; 1995:50-90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281-286.
- Logan C, Holcombe E, Manlove J, Ryan S. The consequences of unintended childbearing. The National Campaign to Prevent Teen Pregnancy and Child Trends. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf. Published May 2007. Accessed January 11, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126-127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154-161.
- Sonfield A, Kost K. Public costs from unintended pregnancy and the role of public insurance program in paying for pregnancy and infant care: Estimates for 2008. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP.pdf. Published October 2013. Accessed January 15, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6-15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: National and state estimates for 2010. Guttmacher Institute; 2015. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Accessed January 29, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med. 2016;374(9):843-852.
- Cortessis VK, Barrett M, Brown Wade N, et al. Intrauterine device use and cervical cancer risk: A systematic review and meta-analysis. Obstet Gynecol. 2017;130(6):1226-1236.
Examining ED Revisits for Migraine in New York City
More than a quarter of initial emergency department (ED) visits for migraine are followed by headache revisits in less than 6 months, a recent study found. Using the New York City Department of Health and Mental Hygiene Syndromic Surveillance database, researchers conducted a retrospective nested cohort study. They analyzed visits from 18 New York City EDs with discharge diagnoses in the first 6 months of 2015, and conducted descriptive analyses to determine the frequency of headache revisit within 6 months of an index ED visit for migraine and the elapsed time to revisit. They found:
- Of 1052 ED visits with an ED discharge diagnosis of migraine during the first 6 months of 2015, 277 patients (26.3%) had a headache revisit within 6 months of their initial migraine visit and 131 (12.5%) had 2 or more revisits at the same hospital.
- Of the revisits for headache, 9% occurred within 72 hours and 46% occurred within 90 days of the initial migraine visit.
- Sex, age, and poverty level were not associated with an ED revisit.
A retrospective nested cohort study of emergency department revisits for migraine in New York City. [Published online ahead of print November 2, 2017]. Headache. doi:10.1111/head.13216.
More than a quarter of initial emergency department (ED) visits for migraine are followed by headache revisits in less than 6 months, a recent study found. Using the New York City Department of Health and Mental Hygiene Syndromic Surveillance database, researchers conducted a retrospective nested cohort study. They analyzed visits from 18 New York City EDs with discharge diagnoses in the first 6 months of 2015, and conducted descriptive analyses to determine the frequency of headache revisit within 6 months of an index ED visit for migraine and the elapsed time to revisit. They found:
- Of 1052 ED visits with an ED discharge diagnosis of migraine during the first 6 months of 2015, 277 patients (26.3%) had a headache revisit within 6 months of their initial migraine visit and 131 (12.5%) had 2 or more revisits at the same hospital.
- Of the revisits for headache, 9% occurred within 72 hours and 46% occurred within 90 days of the initial migraine visit.
- Sex, age, and poverty level were not associated with an ED revisit.
A retrospective nested cohort study of emergency department revisits for migraine in New York City. [Published online ahead of print November 2, 2017]. Headache. doi:10.1111/head.13216.
More than a quarter of initial emergency department (ED) visits for migraine are followed by headache revisits in less than 6 months, a recent study found. Using the New York City Department of Health and Mental Hygiene Syndromic Surveillance database, researchers conducted a retrospective nested cohort study. They analyzed visits from 18 New York City EDs with discharge diagnoses in the first 6 months of 2015, and conducted descriptive analyses to determine the frequency of headache revisit within 6 months of an index ED visit for migraine and the elapsed time to revisit. They found:
- Of 1052 ED visits with an ED discharge diagnosis of migraine during the first 6 months of 2015, 277 patients (26.3%) had a headache revisit within 6 months of their initial migraine visit and 131 (12.5%) had 2 or more revisits at the same hospital.
- Of the revisits for headache, 9% occurred within 72 hours and 46% occurred within 90 days of the initial migraine visit.
- Sex, age, and poverty level were not associated with an ED revisit.
A retrospective nested cohort study of emergency department revisits for migraine in New York City. [Published online ahead of print November 2, 2017]. Headache. doi:10.1111/head.13216.
Physical Activity Worsened Migraine Pain for Some
For a minority of women who are overweight or obese, physical activity consistently contributed to the worsening of migraine pain, according to a recent study. Furthermore, more frequent physical activity-related pain worsening was related to greater severity of other migraine symptoms and pain sensitivity. Participants included 132 women, aged 18 to 50 years, with neurologist-confirmed migraine and overweight/obesity seeking weight loss treatment in the Women’s Health and Migraine trial. Researchers found:
- Subjects reported 5.5 ± 2.8 (mean ± standard deviation) migraine attacks over 28 days.
- The intraclass correlation indicated high consistency in participants’ reports of activity-related pain worsening or not.
- On average, activity worsened pain in 34.8 ± 35.6% of attacks, had no effect on pain in 61.8 ± 34.6% of attacks, and improved pain in 3.4 ± 12.7% of attacks.
- Few participants (9.8%) reported activity-related pain worsening in all attacks.
- A higher percentage of attacks where physical activity worsened pain demonstrated small-sized correlations with more severe nausea, photophobia, phonophobia, and allodynia.
Pain worsening with physical activity during migraine attacks in women with overweight/obesity: A prospective evaluation of frequency, consistency, and correlates. [Published online ahead of print December 13, 2017]. Cephalalgia. doi:10.1177/0333102417747231.
For a minority of women who are overweight or obese, physical activity consistently contributed to the worsening of migraine pain, according to a recent study. Furthermore, more frequent physical activity-related pain worsening was related to greater severity of other migraine symptoms and pain sensitivity. Participants included 132 women, aged 18 to 50 years, with neurologist-confirmed migraine and overweight/obesity seeking weight loss treatment in the Women’s Health and Migraine trial. Researchers found:
- Subjects reported 5.5 ± 2.8 (mean ± standard deviation) migraine attacks over 28 days.
- The intraclass correlation indicated high consistency in participants’ reports of activity-related pain worsening or not.
- On average, activity worsened pain in 34.8 ± 35.6% of attacks, had no effect on pain in 61.8 ± 34.6% of attacks, and improved pain in 3.4 ± 12.7% of attacks.
- Few participants (9.8%) reported activity-related pain worsening in all attacks.
- A higher percentage of attacks where physical activity worsened pain demonstrated small-sized correlations with more severe nausea, photophobia, phonophobia, and allodynia.
Pain worsening with physical activity during migraine attacks in women with overweight/obesity: A prospective evaluation of frequency, consistency, and correlates. [Published online ahead of print December 13, 2017]. Cephalalgia. doi:10.1177/0333102417747231.
For a minority of women who are overweight or obese, physical activity consistently contributed to the worsening of migraine pain, according to a recent study. Furthermore, more frequent physical activity-related pain worsening was related to greater severity of other migraine symptoms and pain sensitivity. Participants included 132 women, aged 18 to 50 years, with neurologist-confirmed migraine and overweight/obesity seeking weight loss treatment in the Women’s Health and Migraine trial. Researchers found:
- Subjects reported 5.5 ± 2.8 (mean ± standard deviation) migraine attacks over 28 days.
- The intraclass correlation indicated high consistency in participants’ reports of activity-related pain worsening or not.
- On average, activity worsened pain in 34.8 ± 35.6% of attacks, had no effect on pain in 61.8 ± 34.6% of attacks, and improved pain in 3.4 ± 12.7% of attacks.
- Few participants (9.8%) reported activity-related pain worsening in all attacks.
- A higher percentage of attacks where physical activity worsened pain demonstrated small-sized correlations with more severe nausea, photophobia, phonophobia, and allodynia.
Pain worsening with physical activity during migraine attacks in women with overweight/obesity: A prospective evaluation of frequency, consistency, and correlates. [Published online ahead of print December 13, 2017]. Cephalalgia. doi:10.1177/0333102417747231.
Contaminated graft causes infection in ALL patient
, according to a letter to the editor published in Infection Control & Hospital Epidemiology.
Strains of Staphylococcus aureus found in isolates from the HSC graft and the patient were confirmed to be identical using pulsed-field gel electrophoresis, the authors, led by Zachary I. Willis, MD, MPH, of the department of pediatrics at the University of North Carolina at Chapel Hill, said.
“While multiple reports have found that low-grade bacterial contamination of HSC products is rarely consequential, our patient’s experience demonstrated that clinically significant infections may occur,” Dr. Willis and his colleagues wrote in the case report.
When less virulent organisms are found in HSC grafts, close observation may be warranted, the investigators said; however, a more aggressive approach might be considered when more virulent organisms are found.
“In such a case, we suggest obtaining blood cultures and considering preemptive antibiotics as guided by the identity and susceptibility of the contaminating organism,” the investigators wrote.
Dr. Willis and his colleagues reported the case of a 15-year-old boy with hypodiploid B-ALL who achieved complete remission after treatment and then underwent a 10/10 HLA allele–matched unrelated donor hematopoietic cell transplant.
The patient developed a fever of 38.3º C with tachycardia but no other sepsis signs approximately 24 hours after the transplant. Soon afterward, the care team was informed that there was a single colony each of Micrococcus and S. aureus in the culture of the HSC product. Methicillin susceptibility was later confirmed. Antibiotic treatment was changed accordingly, and as of 117 days post transplant, the patient was “doing well with no evidence of further infectious complications,” the investigators said.
Bacterial contamination of HSC grafts is relatively common, with reported rates ranging from 1% to 45%. However, the clinical significance of the contamination has been unclear. Moreover, contamination is not an absolute contraindication to infusion, as options for the patient are limited after a myeloablative preparative regimen.
There are some previous case reports also identifying infections caused by contaminated grafts, but in those cases, the evidence linking the graft to the infection was based solely on finding identical species, while in the present report, the graft and patient isolates were confirmed to be identical using pulsed-field gel electrophoresis.
The investigators reported having no outside funding and no financial disclosures.
SOURCE: Willis Z et al, Infect Control Hosp Epidemiol. 2018 Jan 23. doi: 10.1017/ice.2017.285.
, according to a letter to the editor published in Infection Control & Hospital Epidemiology.
Strains of Staphylococcus aureus found in isolates from the HSC graft and the patient were confirmed to be identical using pulsed-field gel electrophoresis, the authors, led by Zachary I. Willis, MD, MPH, of the department of pediatrics at the University of North Carolina at Chapel Hill, said.
“While multiple reports have found that low-grade bacterial contamination of HSC products is rarely consequential, our patient’s experience demonstrated that clinically significant infections may occur,” Dr. Willis and his colleagues wrote in the case report.
When less virulent organisms are found in HSC grafts, close observation may be warranted, the investigators said; however, a more aggressive approach might be considered when more virulent organisms are found.
“In such a case, we suggest obtaining blood cultures and considering preemptive antibiotics as guided by the identity and susceptibility of the contaminating organism,” the investigators wrote.
Dr. Willis and his colleagues reported the case of a 15-year-old boy with hypodiploid B-ALL who achieved complete remission after treatment and then underwent a 10/10 HLA allele–matched unrelated donor hematopoietic cell transplant.
The patient developed a fever of 38.3º C with tachycardia but no other sepsis signs approximately 24 hours after the transplant. Soon afterward, the care team was informed that there was a single colony each of Micrococcus and S. aureus in the culture of the HSC product. Methicillin susceptibility was later confirmed. Antibiotic treatment was changed accordingly, and as of 117 days post transplant, the patient was “doing well with no evidence of further infectious complications,” the investigators said.
Bacterial contamination of HSC grafts is relatively common, with reported rates ranging from 1% to 45%. However, the clinical significance of the contamination has been unclear. Moreover, contamination is not an absolute contraindication to infusion, as options for the patient are limited after a myeloablative preparative regimen.
There are some previous case reports also identifying infections caused by contaminated grafts, but in those cases, the evidence linking the graft to the infection was based solely on finding identical species, while in the present report, the graft and patient isolates were confirmed to be identical using pulsed-field gel electrophoresis.
The investigators reported having no outside funding and no financial disclosures.
SOURCE: Willis Z et al, Infect Control Hosp Epidemiol. 2018 Jan 23. doi: 10.1017/ice.2017.285.
, according to a letter to the editor published in Infection Control & Hospital Epidemiology.
Strains of Staphylococcus aureus found in isolates from the HSC graft and the patient were confirmed to be identical using pulsed-field gel electrophoresis, the authors, led by Zachary I. Willis, MD, MPH, of the department of pediatrics at the University of North Carolina at Chapel Hill, said.
“While multiple reports have found that low-grade bacterial contamination of HSC products is rarely consequential, our patient’s experience demonstrated that clinically significant infections may occur,” Dr. Willis and his colleagues wrote in the case report.
When less virulent organisms are found in HSC grafts, close observation may be warranted, the investigators said; however, a more aggressive approach might be considered when more virulent organisms are found.
“In such a case, we suggest obtaining blood cultures and considering preemptive antibiotics as guided by the identity and susceptibility of the contaminating organism,” the investigators wrote.
Dr. Willis and his colleagues reported the case of a 15-year-old boy with hypodiploid B-ALL who achieved complete remission after treatment and then underwent a 10/10 HLA allele–matched unrelated donor hematopoietic cell transplant.
The patient developed a fever of 38.3º C with tachycardia but no other sepsis signs approximately 24 hours after the transplant. Soon afterward, the care team was informed that there was a single colony each of Micrococcus and S. aureus in the culture of the HSC product. Methicillin susceptibility was later confirmed. Antibiotic treatment was changed accordingly, and as of 117 days post transplant, the patient was “doing well with no evidence of further infectious complications,” the investigators said.
Bacterial contamination of HSC grafts is relatively common, with reported rates ranging from 1% to 45%. However, the clinical significance of the contamination has been unclear. Moreover, contamination is not an absolute contraindication to infusion, as options for the patient are limited after a myeloablative preparative regimen.
There are some previous case reports also identifying infections caused by contaminated grafts, but in those cases, the evidence linking the graft to the infection was based solely on finding identical species, while in the present report, the graft and patient isolates were confirmed to be identical using pulsed-field gel electrophoresis.
The investigators reported having no outside funding and no financial disclosures.
SOURCE: Willis Z et al, Infect Control Hosp Epidemiol. 2018 Jan 23. doi: 10.1017/ice.2017.285.
FROM INFECTION CONTROL & HOSPITAL EPIDEMIOLOGY