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CML: Renal function decline in TKI users
Key clinical point: There is a decline in renal function among patients with chronic myeloid leukaemia (CML) treated with tyrosine kinase inhibitors (TKIs).
Major finding: There was a significant reduction between the first and final recorded estimated glomerular filtration rate across all patients, declining by a mean of -12 mL/minute/1.73m2 over the 10 years of measurement.
Study details: The data come from a retrospective analysis of 50 patients with CML treated with TKI therapy for at least 2 years.
Disclosures: No information on funding was available. The presenting author R Hinton declared no conflicts of interest. The second author S Arami reported relationships with various pharmaceutical companies.
Source: Hinton R et al. Poster. Abstract 053. BSH 2020. 2020 Nov 9-14.
Key clinical point: There is a decline in renal function among patients with chronic myeloid leukaemia (CML) treated with tyrosine kinase inhibitors (TKIs).
Major finding: There was a significant reduction between the first and final recorded estimated glomerular filtration rate across all patients, declining by a mean of -12 mL/minute/1.73m2 over the 10 years of measurement.
Study details: The data come from a retrospective analysis of 50 patients with CML treated with TKI therapy for at least 2 years.
Disclosures: No information on funding was available. The presenting author R Hinton declared no conflicts of interest. The second author S Arami reported relationships with various pharmaceutical companies.
Source: Hinton R et al. Poster. Abstract 053. BSH 2020. 2020 Nov 9-14.
Key clinical point: There is a decline in renal function among patients with chronic myeloid leukaemia (CML) treated with tyrosine kinase inhibitors (TKIs).
Major finding: There was a significant reduction between the first and final recorded estimated glomerular filtration rate across all patients, declining by a mean of -12 mL/minute/1.73m2 over the 10 years of measurement.
Study details: The data come from a retrospective analysis of 50 patients with CML treated with TKI therapy for at least 2 years.
Disclosures: No information on funding was available. The presenting author R Hinton declared no conflicts of interest. The second author S Arami reported relationships with various pharmaceutical companies.
Source: Hinton R et al. Poster. Abstract 053. BSH 2020. 2020 Nov 9-14.
Conception-related outcomes of TKI-treated male patients with CML
Key clinical point: This analysis of more than 400 conceptions revealed that the rate of malformations was 2.5% in offsprings of fathers who did not discontinue tyrosine kinase inhibitors (TKIs) before conception, comparable to that measured in the general population.
Major finding: A total of 428 pregnancies from 374 fathers conceived without treatment discontinuation, 400 of which (93.5%) ended up in a live birth. Malformation was reported in 10 offsprings (2.5% of total live births): 6 with imatinib (1.9% of 313 live births), 2 with nilotinib (7.7% of 26 live births), 1 with dasatinib (2.3% of 43 live births), and none with bosutinib (0% of 12 live births).
Study details: A systematic review of 27 nonoverlapping cohorts of patients or case studies.
Disclosures: Study costs were covered by the Economic Development and Innovation Operative Programme Grant; Human Resources Development Operational Programme Grants; and the New National Excellence Programme, Ministry of Human Capacities. The authors declared no conflicts of interest.
Source: Szakács Z et al. PLoS One. 2020 Dec 3. doi: 10.1371/journal.pone.0243045.
Key clinical point: This analysis of more than 400 conceptions revealed that the rate of malformations was 2.5% in offsprings of fathers who did not discontinue tyrosine kinase inhibitors (TKIs) before conception, comparable to that measured in the general population.
Major finding: A total of 428 pregnancies from 374 fathers conceived without treatment discontinuation, 400 of which (93.5%) ended up in a live birth. Malformation was reported in 10 offsprings (2.5% of total live births): 6 with imatinib (1.9% of 313 live births), 2 with nilotinib (7.7% of 26 live births), 1 with dasatinib (2.3% of 43 live births), and none with bosutinib (0% of 12 live births).
Study details: A systematic review of 27 nonoverlapping cohorts of patients or case studies.
Disclosures: Study costs were covered by the Economic Development and Innovation Operative Programme Grant; Human Resources Development Operational Programme Grants; and the New National Excellence Programme, Ministry of Human Capacities. The authors declared no conflicts of interest.
Source: Szakács Z et al. PLoS One. 2020 Dec 3. doi: 10.1371/journal.pone.0243045.
Key clinical point: This analysis of more than 400 conceptions revealed that the rate of malformations was 2.5% in offsprings of fathers who did not discontinue tyrosine kinase inhibitors (TKIs) before conception, comparable to that measured in the general population.
Major finding: A total of 428 pregnancies from 374 fathers conceived without treatment discontinuation, 400 of which (93.5%) ended up in a live birth. Malformation was reported in 10 offsprings (2.5% of total live births): 6 with imatinib (1.9% of 313 live births), 2 with nilotinib (7.7% of 26 live births), 1 with dasatinib (2.3% of 43 live births), and none with bosutinib (0% of 12 live births).
Study details: A systematic review of 27 nonoverlapping cohorts of patients or case studies.
Disclosures: Study costs were covered by the Economic Development and Innovation Operative Programme Grant; Human Resources Development Operational Programme Grants; and the New National Excellence Programme, Ministry of Human Capacities. The authors declared no conflicts of interest.
Source: Szakács Z et al. PLoS One. 2020 Dec 3. doi: 10.1371/journal.pone.0243045.
CML: TKI discontinuation is safe, improves patient-reported outcomes
Key clinical point: In patients with chronic myeloid leukemia (CML), tyrosine kinase inhibitor (TKI) discontinuation seems safe and feasible and is associated with improvements in patient-reported outcomes (PROs).
Major finding: Overall, 65.5% of patients stayed in major molecular response loss, 60.8% achieved treatment-free remission (TFR), and 34.5% had molecular recurrence (MRec). Detectable BCR-ABL1 by real-time quantitative polymerase chain reaction (PCR) or droplet digital PCR at the time of TKI discontinuation was associated with a greater risk of MRec. In patients who had reached TFR at 12 months, TKI discontinuation was associated with improvements in patient-reported fatigue, diarrhea, depression, and sleep disturbance.
Study details: In this prospective single-group nonrandomized LAST study, MRec and PROs after TKI discontinuation for 172 patients with CML in chronic phase (median age, 60 years) from 14 U.S. sites were evaluated. Included patients had well-controlled disease while treated with imatinib, dasatinib, nilotinib, or bosutinib.
Disclosures: This research was supported by a grant from the U.S. National Cancer Institute. The presenting author reported receiving personal fees from Novartis, Bristol Myers Squibb, and Takeda and research support from Novartis and Takeda.
Source: Atallah E et al. JAMA Oncol. 2020 Nov 12. doi: 10.1001/jamaoncol.2020.5774.
Key clinical point: In patients with chronic myeloid leukemia (CML), tyrosine kinase inhibitor (TKI) discontinuation seems safe and feasible and is associated with improvements in patient-reported outcomes (PROs).
Major finding: Overall, 65.5% of patients stayed in major molecular response loss, 60.8% achieved treatment-free remission (TFR), and 34.5% had molecular recurrence (MRec). Detectable BCR-ABL1 by real-time quantitative polymerase chain reaction (PCR) or droplet digital PCR at the time of TKI discontinuation was associated with a greater risk of MRec. In patients who had reached TFR at 12 months, TKI discontinuation was associated with improvements in patient-reported fatigue, diarrhea, depression, and sleep disturbance.
Study details: In this prospective single-group nonrandomized LAST study, MRec and PROs after TKI discontinuation for 172 patients with CML in chronic phase (median age, 60 years) from 14 U.S. sites were evaluated. Included patients had well-controlled disease while treated with imatinib, dasatinib, nilotinib, or bosutinib.
Disclosures: This research was supported by a grant from the U.S. National Cancer Institute. The presenting author reported receiving personal fees from Novartis, Bristol Myers Squibb, and Takeda and research support from Novartis and Takeda.
Source: Atallah E et al. JAMA Oncol. 2020 Nov 12. doi: 10.1001/jamaoncol.2020.5774.
Key clinical point: In patients with chronic myeloid leukemia (CML), tyrosine kinase inhibitor (TKI) discontinuation seems safe and feasible and is associated with improvements in patient-reported outcomes (PROs).
Major finding: Overall, 65.5% of patients stayed in major molecular response loss, 60.8% achieved treatment-free remission (TFR), and 34.5% had molecular recurrence (MRec). Detectable BCR-ABL1 by real-time quantitative polymerase chain reaction (PCR) or droplet digital PCR at the time of TKI discontinuation was associated with a greater risk of MRec. In patients who had reached TFR at 12 months, TKI discontinuation was associated with improvements in patient-reported fatigue, diarrhea, depression, and sleep disturbance.
Study details: In this prospective single-group nonrandomized LAST study, MRec and PROs after TKI discontinuation for 172 patients with CML in chronic phase (median age, 60 years) from 14 U.S. sites were evaluated. Included patients had well-controlled disease while treated with imatinib, dasatinib, nilotinib, or bosutinib.
Disclosures: This research was supported by a grant from the U.S. National Cancer Institute. The presenting author reported receiving personal fees from Novartis, Bristol Myers Squibb, and Takeda and research support from Novartis and Takeda.
Source: Atallah E et al. JAMA Oncol. 2020 Nov 12. doi: 10.1001/jamaoncol.2020.5774.
CML: Asciminib shows efficacy and safety in phase 3 ASCEMBL trial
Key clinical point: Asciminib, a first-in-class STAMP inhibitor, may be a new treatment option for patients with chronic myeloid leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosine kinase inhibitors.
Major finding: Major molecular response rate at 24 weeks was 25.5% with asciminib and 13.2% with bosutinib (BOS). The between-arm common treatment difference after adjustment for major cytogenetic response status at baseline was 12.2% (2-sided P = .029). Patients treated with asciminib were also twice as likely to achieve a deep molecular response. Grade 3 or greater adverse events were reported in 50.6% and 60.5% of patients receiving asciminib and BOS, respectively.
Study details: In this phase 3 ASCEMBL trial, 233 patients with CML-CP previously treated with 2 or more TKIs were randomly assigned (2:1) to receive asciminib 40 mg twice daily or BOS 500 mg once daily (median follow-up duration, 14.9 months).
Disclosures: The study is sponsored by Novartis. Some of the investigators reported ties with pharmaceutical companies, including Novartis.
Source: Hochhaus A et al. ASH Annual Meeting and Exposition 2020. Abstract LBA-4.
Key clinical point: Asciminib, a first-in-class STAMP inhibitor, may be a new treatment option for patients with chronic myeloid leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosine kinase inhibitors.
Major finding: Major molecular response rate at 24 weeks was 25.5% with asciminib and 13.2% with bosutinib (BOS). The between-arm common treatment difference after adjustment for major cytogenetic response status at baseline was 12.2% (2-sided P = .029). Patients treated with asciminib were also twice as likely to achieve a deep molecular response. Grade 3 or greater adverse events were reported in 50.6% and 60.5% of patients receiving asciminib and BOS, respectively.
Study details: In this phase 3 ASCEMBL trial, 233 patients with CML-CP previously treated with 2 or more TKIs were randomly assigned (2:1) to receive asciminib 40 mg twice daily or BOS 500 mg once daily (median follow-up duration, 14.9 months).
Disclosures: The study is sponsored by Novartis. Some of the investigators reported ties with pharmaceutical companies, including Novartis.
Source: Hochhaus A et al. ASH Annual Meeting and Exposition 2020. Abstract LBA-4.
Key clinical point: Asciminib, a first-in-class STAMP inhibitor, may be a new treatment option for patients with chronic myeloid leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosine kinase inhibitors.
Major finding: Major molecular response rate at 24 weeks was 25.5% with asciminib and 13.2% with bosutinib (BOS). The between-arm common treatment difference after adjustment for major cytogenetic response status at baseline was 12.2% (2-sided P = .029). Patients treated with asciminib were also twice as likely to achieve a deep molecular response. Grade 3 or greater adverse events were reported in 50.6% and 60.5% of patients receiving asciminib and BOS, respectively.
Study details: In this phase 3 ASCEMBL trial, 233 patients with CML-CP previously treated with 2 or more TKIs were randomly assigned (2:1) to receive asciminib 40 mg twice daily or BOS 500 mg once daily (median follow-up duration, 14.9 months).
Disclosures: The study is sponsored by Novartis. Some of the investigators reported ties with pharmaceutical companies, including Novartis.
Source: Hochhaus A et al. ASH Annual Meeting and Exposition 2020. Abstract LBA-4.
Calcium-induced autonomic denervation linked to lower post-op AF
Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.
“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.
The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.
Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.
After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.
The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.
“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
Is ‘nuisance’ arrhythmia worth targeting?
In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.
“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.
“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”
Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.
“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.
The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.
Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.
“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.
The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.
Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.
After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.
The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.
“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
Is ‘nuisance’ arrhythmia worth targeting?
In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.
“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.
“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”
Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.
“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.
The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.
Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.
“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.
The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.
Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.
After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.
The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.
“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
Is ‘nuisance’ arrhythmia worth targeting?
In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.
“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.
“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”
Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.
“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.
The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
How can hospitalists change the status quo?
Lean framework for efficiency and empathy of care
“My census is too high.”
“I don’t have enough time to talk to patients.”
“These are outside our scope of practice.”
These are statements that I have heard from colleagues over the last fourteen years as a hospitalist. Back in 1996, when Dr. Bob Wachter coined the term ‘hospitalist,’ we were still in our infancy – the scope of what we could do had yet to be fully realized. Our focus was on providing care for hospitalized patients and improving quality of clinical care and patient safety. As health care organizations began to see the potential for our field, the demands on our services grew. We grew to comanage patients with our surgical colleagues, worked on patient satisfaction, facilitated transitions of care, and attempted to reduce readmissions – all of which improved patient care and the bottom line for our organizations.
Somewhere along the way, we were expected to staff high patient volumes to add more value, but this always seemed to come with compromise in another aspect of care or our own well-being. After all, there are only so many hours in the day and a limit on what one individual can accomplish in that time.
One of the reasons I love hospital medicine is the novelty of what we do – we are creative thinkers. We have the capacity to innovate solutions to hospital problems based on our expertise as frontline providers for our patients. Hospitalists of every discipline staff a large majority of inpatients, which makes our collective experience significant to the management of inpatient health care. We are often the ones tasked with executing improvement projects, but how often are we involved in their design? I know that we collectively have an enormous opportunity to improve our health care practice, both for ourselves, our patients, and the institutions we work for. But more than just being a voice of advocacy, we need to understand how to positively influence the health care structures that allow us to deliver quality patient care.
It is no surprise that the inefficiencies we deal with in our hospitals are many – daily workflow interruptions, delays in results, scheduling issues, communication difficulties. These are not unique to any one institution. The pandemic added more to that plate – PPE deficiencies, patient volume triage, and resource management are examples. Hospitals often contract consultants to help solve these problems, and many utilize a variety of frameworks to improve these system processes. The Lean framework is one of these, and it originated in the manufacturing industry to eliminate waste in systems in the pursuit of efficiency.
In my business training and prior hospital medicine leadership roles, I was educated in Lean thinking and methodologies for improving quality and applied its principles to projects for improving workflow. Last year I attended a virtual conference on ‘Lean Innovation during the pandemic’ for New York region hospitals, and it again highlighted how the Lean management methodology can help improve patient care but importantly, our workflow as clinicians. This got me thinking. Why is Lean well accepted in business and manufacturing circles, but less so in health care?
I think the answer is twofold – knowledge and people.
What is Lean and how can it help us?
The ‘Toyota Production System’-based philosophy has 14 core principles that help eliminate waste in systems in pursuit of efficiency. These principles are the “Toyota Way.” They center around two pillars: continuous improvement and respect for people. The cornerstone of this management methodology is based on efficient processes, developing employees to add value to the organization and continuous improvement through problem-solving and organizational learning.
Lean is often implemented with Six Sigma methodology. Six Sigma has its origins in Motorola. While Lean cuts waste in our systems to provide value, Six Sigma uses DMAIC (Define, Measure, Analyze, Improve, Control) to reduce variation in our processes. When done in its entirety, Lean Six Sigma methodology adds value by increasing efficiency, reducing cost, and improving our everyday work.
Statistical principles suggest that 80% of consequences comes from 20% of causes. Lean methodology and tools allow us to systematically identify root causes for the problems we face and help narrow it down to the ‘vital few.’ In other words, fixing these would give us the most bang for our buck. As hospitalists, we are able to do this better than most because we work in these hospital processes everyday – we truly know the strengths and weaknesses of our systems.
As a hospitalist, I would love for the process of seeing patients in hospitals to be more efficient, less variable, and be more cost-effective for my institution. By eliminating the time wasted performing unnecessary and redundant tasks in my everyday work, I can reallocate that time to patient care – the very reason I chose a career in medicine.
We, the people
There are two common rebuttals I hear for adopting Lean Six Sigma methodology in health care. A frequent misconception is that Lean is all about reducing staff or time with patients. The second is that manufacturing methodologies do not work for a service profession. For instance, an article published on Reuters Events (www.reutersevents.com/supplychain/supply-chain/end-just-time) talks about Lean JIT (Just In Time) inventory as a culprit for creating a supply chain deficit during COVID-19. It is not entirely without merit. However, if done the correct way, Lean is all about involving the frontline worker to create a workflow that would work best for them.
Reducing the waste in our processes and empowering our frontline doctors to be creative in finding solutions naturally leads to cost reduction. The cornerstone of Lean is creating a continuously learning organization and putting your employees at the forefront. I think it is important that Lean principles be utilized within health care – but we cannot push to fix every problem in our systems to perfection at a significant expense to the physician and other health care staff.
Why HM can benefit from Lean
There is no hard and fast rule about the way health care should adopt Lean thinking. It is a way of thinking that aims to balance purpose, people, and process – extremes of inventory management may not be necessary to be successful in health care. Lean tools alone would not create results. John Shook, chairman of Lean Global Network, has said that the social side of Lean needs to be in balance with the technical side. In other words, rigidity and efficiency is good, but so is encouraging creativity and flexibility in thinking within the workforce.
In the crisis created by the novel coronavirus, many hospitals in New York state, including my own, turned to Lean to respond quickly and effectively to the challenges. Lean principles helped them problem-solve and develop strategies to both recover from the pandemic surge and adapt to future problems that could occur. Geographic clustering of patients, PPE supply, OR shut down and ramp up, emergency management offices at the peak of the pandemic, telehealth streamlining, and post-COVID-19 care planning are some areas where the application of Lean resulted in successful responses to the challenges that 2020 brought to our work.
As Warren Bennis said, ‘The manager accepts the status quo; the leader challenges it.’ As hospitalists, we can lead the way our hospitals provide care. Lean is not just a way for hospitals to cut costs (although it helps quite a bit there). Its processes and philosophies could enable hospitalists to maximize potential, efficiency, quality of care, and allow for a balanced work environment. When applied in a manner that focuses on continuous improvement (and is cognizant of its limitations), it has the potential to increase the capability of our service lines and streamline our processes and workday for greater efficiency. As a specialty, we stand to benefit by taking the lead role in choosing how best to improve how we work. We should think outside the box. What better time to do this than now?
Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany (N.Y) Medical College. She is a former hospitalist medical director and has served on SHM’s national committees, and is a certified Lean Six Sigma black belt and MBA candidate.
Lean framework for efficiency and empathy of care
Lean framework for efficiency and empathy of care
“My census is too high.”
“I don’t have enough time to talk to patients.”
“These are outside our scope of practice.”
These are statements that I have heard from colleagues over the last fourteen years as a hospitalist. Back in 1996, when Dr. Bob Wachter coined the term ‘hospitalist,’ we were still in our infancy – the scope of what we could do had yet to be fully realized. Our focus was on providing care for hospitalized patients and improving quality of clinical care and patient safety. As health care organizations began to see the potential for our field, the demands on our services grew. We grew to comanage patients with our surgical colleagues, worked on patient satisfaction, facilitated transitions of care, and attempted to reduce readmissions – all of which improved patient care and the bottom line for our organizations.
Somewhere along the way, we were expected to staff high patient volumes to add more value, but this always seemed to come with compromise in another aspect of care or our own well-being. After all, there are only so many hours in the day and a limit on what one individual can accomplish in that time.
One of the reasons I love hospital medicine is the novelty of what we do – we are creative thinkers. We have the capacity to innovate solutions to hospital problems based on our expertise as frontline providers for our patients. Hospitalists of every discipline staff a large majority of inpatients, which makes our collective experience significant to the management of inpatient health care. We are often the ones tasked with executing improvement projects, but how often are we involved in their design? I know that we collectively have an enormous opportunity to improve our health care practice, both for ourselves, our patients, and the institutions we work for. But more than just being a voice of advocacy, we need to understand how to positively influence the health care structures that allow us to deliver quality patient care.
It is no surprise that the inefficiencies we deal with in our hospitals are many – daily workflow interruptions, delays in results, scheduling issues, communication difficulties. These are not unique to any one institution. The pandemic added more to that plate – PPE deficiencies, patient volume triage, and resource management are examples. Hospitals often contract consultants to help solve these problems, and many utilize a variety of frameworks to improve these system processes. The Lean framework is one of these, and it originated in the manufacturing industry to eliminate waste in systems in the pursuit of efficiency.
In my business training and prior hospital medicine leadership roles, I was educated in Lean thinking and methodologies for improving quality and applied its principles to projects for improving workflow. Last year I attended a virtual conference on ‘Lean Innovation during the pandemic’ for New York region hospitals, and it again highlighted how the Lean management methodology can help improve patient care but importantly, our workflow as clinicians. This got me thinking. Why is Lean well accepted in business and manufacturing circles, but less so in health care?
I think the answer is twofold – knowledge and people.
What is Lean and how can it help us?
The ‘Toyota Production System’-based philosophy has 14 core principles that help eliminate waste in systems in pursuit of efficiency. These principles are the “Toyota Way.” They center around two pillars: continuous improvement and respect for people. The cornerstone of this management methodology is based on efficient processes, developing employees to add value to the organization and continuous improvement through problem-solving and organizational learning.
Lean is often implemented with Six Sigma methodology. Six Sigma has its origins in Motorola. While Lean cuts waste in our systems to provide value, Six Sigma uses DMAIC (Define, Measure, Analyze, Improve, Control) to reduce variation in our processes. When done in its entirety, Lean Six Sigma methodology adds value by increasing efficiency, reducing cost, and improving our everyday work.
Statistical principles suggest that 80% of consequences comes from 20% of causes. Lean methodology and tools allow us to systematically identify root causes for the problems we face and help narrow it down to the ‘vital few.’ In other words, fixing these would give us the most bang for our buck. As hospitalists, we are able to do this better than most because we work in these hospital processes everyday – we truly know the strengths and weaknesses of our systems.
As a hospitalist, I would love for the process of seeing patients in hospitals to be more efficient, less variable, and be more cost-effective for my institution. By eliminating the time wasted performing unnecessary and redundant tasks in my everyday work, I can reallocate that time to patient care – the very reason I chose a career in medicine.
We, the people
There are two common rebuttals I hear for adopting Lean Six Sigma methodology in health care. A frequent misconception is that Lean is all about reducing staff or time with patients. The second is that manufacturing methodologies do not work for a service profession. For instance, an article published on Reuters Events (www.reutersevents.com/supplychain/supply-chain/end-just-time) talks about Lean JIT (Just In Time) inventory as a culprit for creating a supply chain deficit during COVID-19. It is not entirely without merit. However, if done the correct way, Lean is all about involving the frontline worker to create a workflow that would work best for them.
Reducing the waste in our processes and empowering our frontline doctors to be creative in finding solutions naturally leads to cost reduction. The cornerstone of Lean is creating a continuously learning organization and putting your employees at the forefront. I think it is important that Lean principles be utilized within health care – but we cannot push to fix every problem in our systems to perfection at a significant expense to the physician and other health care staff.
Why HM can benefit from Lean
There is no hard and fast rule about the way health care should adopt Lean thinking. It is a way of thinking that aims to balance purpose, people, and process – extremes of inventory management may not be necessary to be successful in health care. Lean tools alone would not create results. John Shook, chairman of Lean Global Network, has said that the social side of Lean needs to be in balance with the technical side. In other words, rigidity and efficiency is good, but so is encouraging creativity and flexibility in thinking within the workforce.
In the crisis created by the novel coronavirus, many hospitals in New York state, including my own, turned to Lean to respond quickly and effectively to the challenges. Lean principles helped them problem-solve and develop strategies to both recover from the pandemic surge and adapt to future problems that could occur. Geographic clustering of patients, PPE supply, OR shut down and ramp up, emergency management offices at the peak of the pandemic, telehealth streamlining, and post-COVID-19 care planning are some areas where the application of Lean resulted in successful responses to the challenges that 2020 brought to our work.
As Warren Bennis said, ‘The manager accepts the status quo; the leader challenges it.’ As hospitalists, we can lead the way our hospitals provide care. Lean is not just a way for hospitals to cut costs (although it helps quite a bit there). Its processes and philosophies could enable hospitalists to maximize potential, efficiency, quality of care, and allow for a balanced work environment. When applied in a manner that focuses on continuous improvement (and is cognizant of its limitations), it has the potential to increase the capability of our service lines and streamline our processes and workday for greater efficiency. As a specialty, we stand to benefit by taking the lead role in choosing how best to improve how we work. We should think outside the box. What better time to do this than now?
Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany (N.Y) Medical College. She is a former hospitalist medical director and has served on SHM’s national committees, and is a certified Lean Six Sigma black belt and MBA candidate.
“My census is too high.”
“I don’t have enough time to talk to patients.”
“These are outside our scope of practice.”
These are statements that I have heard from colleagues over the last fourteen years as a hospitalist. Back in 1996, when Dr. Bob Wachter coined the term ‘hospitalist,’ we were still in our infancy – the scope of what we could do had yet to be fully realized. Our focus was on providing care for hospitalized patients and improving quality of clinical care and patient safety. As health care organizations began to see the potential for our field, the demands on our services grew. We grew to comanage patients with our surgical colleagues, worked on patient satisfaction, facilitated transitions of care, and attempted to reduce readmissions – all of which improved patient care and the bottom line for our organizations.
Somewhere along the way, we were expected to staff high patient volumes to add more value, but this always seemed to come with compromise in another aspect of care or our own well-being. After all, there are only so many hours in the day and a limit on what one individual can accomplish in that time.
One of the reasons I love hospital medicine is the novelty of what we do – we are creative thinkers. We have the capacity to innovate solutions to hospital problems based on our expertise as frontline providers for our patients. Hospitalists of every discipline staff a large majority of inpatients, which makes our collective experience significant to the management of inpatient health care. We are often the ones tasked with executing improvement projects, but how often are we involved in their design? I know that we collectively have an enormous opportunity to improve our health care practice, both for ourselves, our patients, and the institutions we work for. But more than just being a voice of advocacy, we need to understand how to positively influence the health care structures that allow us to deliver quality patient care.
It is no surprise that the inefficiencies we deal with in our hospitals are many – daily workflow interruptions, delays in results, scheduling issues, communication difficulties. These are not unique to any one institution. The pandemic added more to that plate – PPE deficiencies, patient volume triage, and resource management are examples. Hospitals often contract consultants to help solve these problems, and many utilize a variety of frameworks to improve these system processes. The Lean framework is one of these, and it originated in the manufacturing industry to eliminate waste in systems in the pursuit of efficiency.
In my business training and prior hospital medicine leadership roles, I was educated in Lean thinking and methodologies for improving quality and applied its principles to projects for improving workflow. Last year I attended a virtual conference on ‘Lean Innovation during the pandemic’ for New York region hospitals, and it again highlighted how the Lean management methodology can help improve patient care but importantly, our workflow as clinicians. This got me thinking. Why is Lean well accepted in business and manufacturing circles, but less so in health care?
I think the answer is twofold – knowledge and people.
What is Lean and how can it help us?
The ‘Toyota Production System’-based philosophy has 14 core principles that help eliminate waste in systems in pursuit of efficiency. These principles are the “Toyota Way.” They center around two pillars: continuous improvement and respect for people. The cornerstone of this management methodology is based on efficient processes, developing employees to add value to the organization and continuous improvement through problem-solving and organizational learning.
Lean is often implemented with Six Sigma methodology. Six Sigma has its origins in Motorola. While Lean cuts waste in our systems to provide value, Six Sigma uses DMAIC (Define, Measure, Analyze, Improve, Control) to reduce variation in our processes. When done in its entirety, Lean Six Sigma methodology adds value by increasing efficiency, reducing cost, and improving our everyday work.
Statistical principles suggest that 80% of consequences comes from 20% of causes. Lean methodology and tools allow us to systematically identify root causes for the problems we face and help narrow it down to the ‘vital few.’ In other words, fixing these would give us the most bang for our buck. As hospitalists, we are able to do this better than most because we work in these hospital processes everyday – we truly know the strengths and weaknesses of our systems.
As a hospitalist, I would love for the process of seeing patients in hospitals to be more efficient, less variable, and be more cost-effective for my institution. By eliminating the time wasted performing unnecessary and redundant tasks in my everyday work, I can reallocate that time to patient care – the very reason I chose a career in medicine.
We, the people
There are two common rebuttals I hear for adopting Lean Six Sigma methodology in health care. A frequent misconception is that Lean is all about reducing staff or time with patients. The second is that manufacturing methodologies do not work for a service profession. For instance, an article published on Reuters Events (www.reutersevents.com/supplychain/supply-chain/end-just-time) talks about Lean JIT (Just In Time) inventory as a culprit for creating a supply chain deficit during COVID-19. It is not entirely without merit. However, if done the correct way, Lean is all about involving the frontline worker to create a workflow that would work best for them.
Reducing the waste in our processes and empowering our frontline doctors to be creative in finding solutions naturally leads to cost reduction. The cornerstone of Lean is creating a continuously learning organization and putting your employees at the forefront. I think it is important that Lean principles be utilized within health care – but we cannot push to fix every problem in our systems to perfection at a significant expense to the physician and other health care staff.
Why HM can benefit from Lean
There is no hard and fast rule about the way health care should adopt Lean thinking. It is a way of thinking that aims to balance purpose, people, and process – extremes of inventory management may not be necessary to be successful in health care. Lean tools alone would not create results. John Shook, chairman of Lean Global Network, has said that the social side of Lean needs to be in balance with the technical side. In other words, rigidity and efficiency is good, but so is encouraging creativity and flexibility in thinking within the workforce.
In the crisis created by the novel coronavirus, many hospitals in New York state, including my own, turned to Lean to respond quickly and effectively to the challenges. Lean principles helped them problem-solve and develop strategies to both recover from the pandemic surge and adapt to future problems that could occur. Geographic clustering of patients, PPE supply, OR shut down and ramp up, emergency management offices at the peak of the pandemic, telehealth streamlining, and post-COVID-19 care planning are some areas where the application of Lean resulted in successful responses to the challenges that 2020 brought to our work.
As Warren Bennis said, ‘The manager accepts the status quo; the leader challenges it.’ As hospitalists, we can lead the way our hospitals provide care. Lean is not just a way for hospitals to cut costs (although it helps quite a bit there). Its processes and philosophies could enable hospitalists to maximize potential, efficiency, quality of care, and allow for a balanced work environment. When applied in a manner that focuses on continuous improvement (and is cognizant of its limitations), it has the potential to increase the capability of our service lines and streamline our processes and workday for greater efficiency. As a specialty, we stand to benefit by taking the lead role in choosing how best to improve how we work. We should think outside the box. What better time to do this than now?
Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany (N.Y) Medical College. She is a former hospitalist medical director and has served on SHM’s national committees, and is a certified Lean Six Sigma black belt and MBA candidate.
‘Peer respites’ provide an alternative to psychiatric wards during pandemic
Mia McDermott is no stranger to isolation. Abandoned as an infant in China, she lived in an orphanage until a family in California adopted her as a toddler. She spent her adolescence in boarding schools and early adult years in and out of psychiatric hospitals, where she underwent treatment for bipolar disorder, anxiety, and anorexia.
The pandemic left Ms. McDermott feeling especially lonely. She restricted social interactions because her fatty liver disease put her at greater risk of complications should she contract COVID-19. The 26-year-old Santa Cruz, Calif., resident stopped regularly eating and taking her psychiatric medications, and contemplated suicide.
When Ms. McDermott’s thoughts grew increasingly dark in June, she checked into Second Story, a mental health program based in a home not far from her own, where she finds nonclinical support in a peaceful environment from people who have faced similar challenges.
Second Story is what is known as a “peer respite,” a welcoming place where people can stay when they’re experiencing or nearing a mental health crisis. Betting that a low-key wellness approach, coupled with empathy from people who have “been there,” can help people in distress recover, this unorthodox strategy has gained popularity in recent years as the nation grapples with a severe shortage of psychiatric beds that has been exacerbated by the pandemic.
Peer respites allow guests to avoid psychiatric hospitalization and ED visits. They now operate in at least 14 states. California has five, in the San Francisco Bay Area and Los Angeles County.
“When things are really tough and you need extra support but you don’t need hospitalization, where’s that middle ground?” asked Keris Myrick, founder of Hacienda of Hope, a peer respite in Long Beach, Calif.
People with serious mental illness are more likely to experience emotional distress in the pandemic than the general population, said Benjamin Druss, MD, a psychiatrist and professor at Emory University, Atlanta, elaborating that they tend to have smaller social networks and more medical problems.
That was the case with Ms. McDermott. “I don’t have a full-on relationship with my family. My friends are my family,” she said. She yearned to “give them a hug, see their smile, or stand close and take a selfie.”
The next best thing was Second Story, located in a pewter-gray split-level, five-bedroom house in Aptos, a quaint beach community near Ms. McDermott’s Santa Cruz home.
– people who have experienced mental health conditions and are trained and often certified by states to support others with similar issues – and activities like arts, meditation and support groups.
“You can’t tell who’s the guest and who’s the staff. We don’t wear uniforms or badges,” said Angelica Garcia-Guerrero, associate director of Hacienda of Hope’s parent organization.
Peer respites are free for guests but rarely covered by insurance. States and counties typically pick up the tab. Hacienda of Hope’s $900,000 annual operating costs are covered by Los Angeles County through the Mental Health Services Act, a policy that directs proceeds from a statewide tax on people who earn more than $1 million annually to behavioral health programs.
In September, California Gov. Gavin Newsom signed a bill that would establish a statewide certification process for mental health peer providers by July 2022.
For now, however, peer-respite staff members in California are not licensed or certified. Peer respites typically don’t offer clinical care or dispense psychiatric drugs, though guests can bring theirs. Peers share personal stories with guests but avoid labeling them with diagnoses. Guests must come – and can leave – voluntarily. Some respites have few restrictions on who can stay; others don’t allow guests who express suicidal thoughts or are homeless.
Peer respite is one of several types of programs that divert people facing behavioral health crises from the hospital, but the only one without clinical involvement, said Travis Atkinson, a consultant at TBD Solutions, a behavioral health care company. The first peer respites arose around 2000, said Laysha Ostrow, CEO of Live & Learn, which conducts behavioral health research.
The approach seems to be expanding. Live & Learn currently counts 33 peer respites in the United States, up from 19 6 years ago. All are overseen and staffed by people with histories of psychiatric disorders. About a dozen other programs employ a mix of peers and laypeople who don’t have psychiatric diagnoses, or aren’t peer led, Mr. Atkinson said.
Though she had stayed at Second Story several times over the past 5 years, Ms. McDermott hesitated to return during the pandemic. However, she felt reassured after learning that guests were required to wear a mask in common areas and get a COVID test before their stay. To ensure physical distancing, the respite reduced capacity from six to five guests at a time.
During her 2-week stay, Ms. McDermott played with the respite’s two cats and piano – activities she found therapeutic. But most helpful was talking to peers in a way she couldn’t with her mental health providers. In the past, Ms. McDermott said, she had been involuntarily admitted to a psychiatric hospital after she expressed suicidal thoughts. When she shared similar sentiments with Second Story peers, they offered to talk, or call the hospital if she wanted.
“They were willing to listen,” she said. “But they’re not forceful about helping.”
By the end of the visit, Ms. McDermott said that she felt understood and her loneliness and suicidal feelings had waned. She started eating and taking her medications more consistently.
The small number of studies on respites have found that guests had fewer hospitalizations and accounted for lower Medicaid spending for nearly a year after a respite stay than people with similar conditions who did not stay in a respite. Respite visitors spent less time in the hospital and emergency room the longer they stayed in the respite.
Financial struggles and opposition from neighbors have hindered the growth of respites, however. Live & Learn said that, although five peer respites have been created since 2018, at least two others closed because of budget cuts.
Neighbors have challenged nearby respite placements in a few instances. Santa Cruz–area media outlets reported in 2019 that Second Story neighbors had voiced safety concerns with the respite. Neighbor Tony Crane said in an interview that guests have used drugs and consumed alcohol in the neighborhood, and he worried that peers are not licensed or certified to support people in crisis. He felt it was too risky to let his children ride their bikes near the respite when they were younger.
In a written response, Monica Martinez, whose organization runs Second Story, said neighbors often target community mental health programs because of concerns that “come from misconceptions and stigma surrounding those seeking mental health support.”
Many respites are struggling with increased demand and decreased availability during the pandemic. Sherry Jenkins Tucker, executive director of Georgia Mental Health Consumer Network, said its four respites have had to reduce capacity to enable physical distancing, despite increased demand for services. Other respites have temporarily suspended stays because of the pandemic.
Ms. McDermott said her mental health had improved since staying at Second Story in June, but she still struggles with isolation amid the pandemic. “Holidays are hard for me,” said Ms. McDermott, who returned to Second Story in November. “I really wanted to be able to have Thanksgiving with people.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Mia McDermott is no stranger to isolation. Abandoned as an infant in China, she lived in an orphanage until a family in California adopted her as a toddler. She spent her adolescence in boarding schools and early adult years in and out of psychiatric hospitals, where she underwent treatment for bipolar disorder, anxiety, and anorexia.
The pandemic left Ms. McDermott feeling especially lonely. She restricted social interactions because her fatty liver disease put her at greater risk of complications should she contract COVID-19. The 26-year-old Santa Cruz, Calif., resident stopped regularly eating and taking her psychiatric medications, and contemplated suicide.
When Ms. McDermott’s thoughts grew increasingly dark in June, she checked into Second Story, a mental health program based in a home not far from her own, where she finds nonclinical support in a peaceful environment from people who have faced similar challenges.
Second Story is what is known as a “peer respite,” a welcoming place where people can stay when they’re experiencing or nearing a mental health crisis. Betting that a low-key wellness approach, coupled with empathy from people who have “been there,” can help people in distress recover, this unorthodox strategy has gained popularity in recent years as the nation grapples with a severe shortage of psychiatric beds that has been exacerbated by the pandemic.
Peer respites allow guests to avoid psychiatric hospitalization and ED visits. They now operate in at least 14 states. California has five, in the San Francisco Bay Area and Los Angeles County.
“When things are really tough and you need extra support but you don’t need hospitalization, where’s that middle ground?” asked Keris Myrick, founder of Hacienda of Hope, a peer respite in Long Beach, Calif.
People with serious mental illness are more likely to experience emotional distress in the pandemic than the general population, said Benjamin Druss, MD, a psychiatrist and professor at Emory University, Atlanta, elaborating that they tend to have smaller social networks and more medical problems.
That was the case with Ms. McDermott. “I don’t have a full-on relationship with my family. My friends are my family,” she said. She yearned to “give them a hug, see their smile, or stand close and take a selfie.”
The next best thing was Second Story, located in a pewter-gray split-level, five-bedroom house in Aptos, a quaint beach community near Ms. McDermott’s Santa Cruz home.
– people who have experienced mental health conditions and are trained and often certified by states to support others with similar issues – and activities like arts, meditation and support groups.
“You can’t tell who’s the guest and who’s the staff. We don’t wear uniforms or badges,” said Angelica Garcia-Guerrero, associate director of Hacienda of Hope’s parent organization.
Peer respites are free for guests but rarely covered by insurance. States and counties typically pick up the tab. Hacienda of Hope’s $900,000 annual operating costs are covered by Los Angeles County through the Mental Health Services Act, a policy that directs proceeds from a statewide tax on people who earn more than $1 million annually to behavioral health programs.
In September, California Gov. Gavin Newsom signed a bill that would establish a statewide certification process for mental health peer providers by July 2022.
For now, however, peer-respite staff members in California are not licensed or certified. Peer respites typically don’t offer clinical care or dispense psychiatric drugs, though guests can bring theirs. Peers share personal stories with guests but avoid labeling them with diagnoses. Guests must come – and can leave – voluntarily. Some respites have few restrictions on who can stay; others don’t allow guests who express suicidal thoughts or are homeless.
Peer respite is one of several types of programs that divert people facing behavioral health crises from the hospital, but the only one without clinical involvement, said Travis Atkinson, a consultant at TBD Solutions, a behavioral health care company. The first peer respites arose around 2000, said Laysha Ostrow, CEO of Live & Learn, which conducts behavioral health research.
The approach seems to be expanding. Live & Learn currently counts 33 peer respites in the United States, up from 19 6 years ago. All are overseen and staffed by people with histories of psychiatric disorders. About a dozen other programs employ a mix of peers and laypeople who don’t have psychiatric diagnoses, or aren’t peer led, Mr. Atkinson said.
Though she had stayed at Second Story several times over the past 5 years, Ms. McDermott hesitated to return during the pandemic. However, she felt reassured after learning that guests were required to wear a mask in common areas and get a COVID test before their stay. To ensure physical distancing, the respite reduced capacity from six to five guests at a time.
During her 2-week stay, Ms. McDermott played with the respite’s two cats and piano – activities she found therapeutic. But most helpful was talking to peers in a way she couldn’t with her mental health providers. In the past, Ms. McDermott said, she had been involuntarily admitted to a psychiatric hospital after she expressed suicidal thoughts. When she shared similar sentiments with Second Story peers, they offered to talk, or call the hospital if she wanted.
“They were willing to listen,” she said. “But they’re not forceful about helping.”
By the end of the visit, Ms. McDermott said that she felt understood and her loneliness and suicidal feelings had waned. She started eating and taking her medications more consistently.
The small number of studies on respites have found that guests had fewer hospitalizations and accounted for lower Medicaid spending for nearly a year after a respite stay than people with similar conditions who did not stay in a respite. Respite visitors spent less time in the hospital and emergency room the longer they stayed in the respite.
Financial struggles and opposition from neighbors have hindered the growth of respites, however. Live & Learn said that, although five peer respites have been created since 2018, at least two others closed because of budget cuts.
Neighbors have challenged nearby respite placements in a few instances. Santa Cruz–area media outlets reported in 2019 that Second Story neighbors had voiced safety concerns with the respite. Neighbor Tony Crane said in an interview that guests have used drugs and consumed alcohol in the neighborhood, and he worried that peers are not licensed or certified to support people in crisis. He felt it was too risky to let his children ride their bikes near the respite when they were younger.
In a written response, Monica Martinez, whose organization runs Second Story, said neighbors often target community mental health programs because of concerns that “come from misconceptions and stigma surrounding those seeking mental health support.”
Many respites are struggling with increased demand and decreased availability during the pandemic. Sherry Jenkins Tucker, executive director of Georgia Mental Health Consumer Network, said its four respites have had to reduce capacity to enable physical distancing, despite increased demand for services. Other respites have temporarily suspended stays because of the pandemic.
Ms. McDermott said her mental health had improved since staying at Second Story in June, but she still struggles with isolation amid the pandemic. “Holidays are hard for me,” said Ms. McDermott, who returned to Second Story in November. “I really wanted to be able to have Thanksgiving with people.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Mia McDermott is no stranger to isolation. Abandoned as an infant in China, she lived in an orphanage until a family in California adopted her as a toddler. She spent her adolescence in boarding schools and early adult years in and out of psychiatric hospitals, where she underwent treatment for bipolar disorder, anxiety, and anorexia.
The pandemic left Ms. McDermott feeling especially lonely. She restricted social interactions because her fatty liver disease put her at greater risk of complications should she contract COVID-19. The 26-year-old Santa Cruz, Calif., resident stopped regularly eating and taking her psychiatric medications, and contemplated suicide.
When Ms. McDermott’s thoughts grew increasingly dark in June, she checked into Second Story, a mental health program based in a home not far from her own, where she finds nonclinical support in a peaceful environment from people who have faced similar challenges.
Second Story is what is known as a “peer respite,” a welcoming place where people can stay when they’re experiencing or nearing a mental health crisis. Betting that a low-key wellness approach, coupled with empathy from people who have “been there,” can help people in distress recover, this unorthodox strategy has gained popularity in recent years as the nation grapples with a severe shortage of psychiatric beds that has been exacerbated by the pandemic.
Peer respites allow guests to avoid psychiatric hospitalization and ED visits. They now operate in at least 14 states. California has five, in the San Francisco Bay Area and Los Angeles County.
“When things are really tough and you need extra support but you don’t need hospitalization, where’s that middle ground?” asked Keris Myrick, founder of Hacienda of Hope, a peer respite in Long Beach, Calif.
People with serious mental illness are more likely to experience emotional distress in the pandemic than the general population, said Benjamin Druss, MD, a psychiatrist and professor at Emory University, Atlanta, elaborating that they tend to have smaller social networks and more medical problems.
That was the case with Ms. McDermott. “I don’t have a full-on relationship with my family. My friends are my family,” she said. She yearned to “give them a hug, see their smile, or stand close and take a selfie.”
The next best thing was Second Story, located in a pewter-gray split-level, five-bedroom house in Aptos, a quaint beach community near Ms. McDermott’s Santa Cruz home.
– people who have experienced mental health conditions and are trained and often certified by states to support others with similar issues – and activities like arts, meditation and support groups.
“You can’t tell who’s the guest and who’s the staff. We don’t wear uniforms or badges,” said Angelica Garcia-Guerrero, associate director of Hacienda of Hope’s parent organization.
Peer respites are free for guests but rarely covered by insurance. States and counties typically pick up the tab. Hacienda of Hope’s $900,000 annual operating costs are covered by Los Angeles County through the Mental Health Services Act, a policy that directs proceeds from a statewide tax on people who earn more than $1 million annually to behavioral health programs.
In September, California Gov. Gavin Newsom signed a bill that would establish a statewide certification process for mental health peer providers by July 2022.
For now, however, peer-respite staff members in California are not licensed or certified. Peer respites typically don’t offer clinical care or dispense psychiatric drugs, though guests can bring theirs. Peers share personal stories with guests but avoid labeling them with diagnoses. Guests must come – and can leave – voluntarily. Some respites have few restrictions on who can stay; others don’t allow guests who express suicidal thoughts or are homeless.
Peer respite is one of several types of programs that divert people facing behavioral health crises from the hospital, but the only one without clinical involvement, said Travis Atkinson, a consultant at TBD Solutions, a behavioral health care company. The first peer respites arose around 2000, said Laysha Ostrow, CEO of Live & Learn, which conducts behavioral health research.
The approach seems to be expanding. Live & Learn currently counts 33 peer respites in the United States, up from 19 6 years ago. All are overseen and staffed by people with histories of psychiatric disorders. About a dozen other programs employ a mix of peers and laypeople who don’t have psychiatric diagnoses, or aren’t peer led, Mr. Atkinson said.
Though she had stayed at Second Story several times over the past 5 years, Ms. McDermott hesitated to return during the pandemic. However, she felt reassured after learning that guests were required to wear a mask in common areas and get a COVID test before their stay. To ensure physical distancing, the respite reduced capacity from six to five guests at a time.
During her 2-week stay, Ms. McDermott played with the respite’s two cats and piano – activities she found therapeutic. But most helpful was talking to peers in a way she couldn’t with her mental health providers. In the past, Ms. McDermott said, she had been involuntarily admitted to a psychiatric hospital after she expressed suicidal thoughts. When she shared similar sentiments with Second Story peers, they offered to talk, or call the hospital if she wanted.
“They were willing to listen,” she said. “But they’re not forceful about helping.”
By the end of the visit, Ms. McDermott said that she felt understood and her loneliness and suicidal feelings had waned. She started eating and taking her medications more consistently.
The small number of studies on respites have found that guests had fewer hospitalizations and accounted for lower Medicaid spending for nearly a year after a respite stay than people with similar conditions who did not stay in a respite. Respite visitors spent less time in the hospital and emergency room the longer they stayed in the respite.
Financial struggles and opposition from neighbors have hindered the growth of respites, however. Live & Learn said that, although five peer respites have been created since 2018, at least two others closed because of budget cuts.
Neighbors have challenged nearby respite placements in a few instances. Santa Cruz–area media outlets reported in 2019 that Second Story neighbors had voiced safety concerns with the respite. Neighbor Tony Crane said in an interview that guests have used drugs and consumed alcohol in the neighborhood, and he worried that peers are not licensed or certified to support people in crisis. He felt it was too risky to let his children ride their bikes near the respite when they were younger.
In a written response, Monica Martinez, whose organization runs Second Story, said neighbors often target community mental health programs because of concerns that “come from misconceptions and stigma surrounding those seeking mental health support.”
Many respites are struggling with increased demand and decreased availability during the pandemic. Sherry Jenkins Tucker, executive director of Georgia Mental Health Consumer Network, said its four respites have had to reduce capacity to enable physical distancing, despite increased demand for services. Other respites have temporarily suspended stays because of the pandemic.
Ms. McDermott said her mental health had improved since staying at Second Story in June, but she still struggles with isolation amid the pandemic. “Holidays are hard for me,” said Ms. McDermott, who returned to Second Story in November. “I really wanted to be able to have Thanksgiving with people.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Adaptive biomarker approach may spare some breast cancer patients chemo
The findings were reported at the 2020 San Antonio Breast Cancer Symposium.
“In early luminal breast cancer, optimal patient selection for omission of adjuvant chemotherapy, particularly in patients with one to three involved lymph nodes, is still unclear,” noted principal investigator Nadia Harbeck, MD, PhD, of the University of Munich.
Successive trials have used nodal status, genomic risk scores, and response to preoperative therapy to home in on subsets of women for whom this practice is safe.
The ADAPT HR+/HER2– trial is a phase 3 trial that enrolled 5,625 patients with luminal (hormone receptor–positive, HER2-negative) early breast cancer who were candidates for adjuvant chemotherapy based on conventional criteria.
The trial combined a static biomarker – Oncotype Dx recurrence score (RS) in the baseline core biopsy – and a dynamic biomarker – Ki-67 response to a 3-week course of preoperative endocrine therapy – to personalize adjuvant therapy.
At SABCS 2020, Dr. Harbeck reported results for 2,290 patients having zero to three involved lymph nodes: 868 patients with RS 0-11 and 1,422 patients with RS 12-25 who had a response to brief preoperative endocrine therapy (a Ki-67 fraction ≤10% at surgery). All were treated with endocrine therapy alone as adjuvant therapy.
Similar outcomes
The median follow-up was 60 months. The 5-year rate of invasive disease–free survival was 93.9% for the group with RS 0-11 and 92.6% for the group with RS 12-25 and a response to the preoperative endocrine therapy.
The study met its primary endpoint, as the lower limit of the 95% confidence interval for the difference between groups of –3.3% fell just within the predefined margin of –3.3% or less for noninferiority (P = .05).
The groups also had similarly “excellent” distant disease–free survival (96.3% for RS 0-11 and 95.6% for RS 12-25; P = .247) and overall survival (98.0% for RS 0-11 and 97.3% for RS 12-25; P = .160), Dr. Harbeck reported.
The similar distant disease–free survival was consistent regardless of whether women were younger or older than 50 years and regardless of whether women had involved nodes or not.
In multivariate analysis, women had greater risk of distant disease–free survival events if they had three positive lymph nodes versus zero to two (hazard ratio, 3.40) or a pathologic T stage of 2-4 versus 0-1 (HR, 2.24), whereas risk fell with increasing baseline progesterone receptor expression (HR, 0.92).
“Neither patient age nor study arm were prognostic factors for patient outcome,” Dr. Harbeck noted.
In stratified analysis, the negative impact of having three positive nodes was seen only in the group with RS 12-25 and response to preoperative endocrine therapy, suggesting this subgroup may not be good candidates for omission of chemotherapy, she said.
Applying results to practice
“In luminal early breast cancer, the following patients – irrespective of their age – can safely be treated by endocrine therapy alone: patients with zero to three involved lymph nodes and recurrence score 0-11, and those with limited nodal burden (zero to two lymph nodes), recurrence score 12-25, and endocrine response after short preoperative endocrine therapy,” Dr. Harbeck summarized.
“Oncotype Dx testing can spare chemotherapy for the majority of patients with up to three involved lymph nodes. Dynamic Ki-67 response testing is feasible in clinical routine and complements baseline risk assessment to define patient selection for therapy deescalation or escalation,” she added.
The investigators have used the trial’s data to develop an algorithm for predicting the probability of response to short-course preoperative endocrine therapy that is available free of charge online (www.enrep.info).
“This may support everyday clinical decision-making in luminal early breast cancer; for example, whether to start a short period of preoperative endocrine therapy at all, and whether to rely on adjuvant endocrine therapy alone, but also in times like these, whether it’s safe to delay surgery by putting patients on prolonged preoperative endocrine therapy if surgical resources are scarce,” Dr. Harbeck commented.
Her clinic is now recruiting patients for the ADAPT Cycle trial, which is testing an endocrine-based approach with a CDK4/6 inhibitor versus chemotherapy in patients who are not candidates for adjuvant endocrine therapy alone. Therefore, all eligible patients receive the short course of endocrine therapy up front as the standard.
“But if you don’t have a trial, what are you going to do on Monday morning? Please let your patient know whether her tumor is endocrine responsive by doing this 3-week preoperative endocrine therapy,” Dr. Harbeck recommended. “It’s easy to do, you can schedule your surgeries better, and in patients with up to three lymph nodes, it helps with your decision-making, not just in the postmenopausal patients but also in the premenopausal patients, regarding whether they can forgo chemotherapy.”
Findings in context
More than 75% of ADAPT patients with RS 12-25 had a response to short-course endocrine therapy, noted invited discussant Lajos Pusztai, MD, DPhil, of the Yale Cancer Center in New Haven, Conn.
“This implies that the endocrine challenge is not informative for most patients,” he said, adding that a related question is whether the 25% of patients who did not have a response and were therefore given chemotherapy benefited from that therapy.
Dr. Pusztai cautioned that, among patients in the group with RS 12-25 who had a response to preoperative endocrine therapy, certain subgroups were fairly or very small: those aged 50 years or younger (330 patients) and those with two or three positive nodes (75 and 22 patients, respectively).
And collective findings of the similar but much larger TAILORx trial and RxPONDER trial (also reported at SABCS 2020) do suggest a benefit of chemotherapy in younger women, regardless of the number of positive nodes.
“Selection of [estrogen receptor]–positive patients with zero to three lymph nodes for adjuvant chemotherapy currently should be based on age and baseline recurrence score or a similar validated molecular assay,” Dr. Pusztai recommended. “TAILORx results guide us in regard to the use of the recurrence score in node-negative patients with a recurrence score of less than 26, and the recently presented RxPONDER results provide evidence for the use of recurrence score in patients with one to three positive nodes with a recurrence score in the range of 0-26. Both of these trials showed benefit in younger women from adjuvant chemotherapy.”
The ADAPT trial was sponsored by Roche, Genomic Health/Exact Sciences, Celgene, Bayer, Teva, and Amgen. Dr. Harbeck disclosed relationships with Agendia, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Lilly, Merck, Novartis, Odonate Therapeutics, Pfizer, Pierre Fabre, Roche/Genentech, Samsung, Sandoz, and Seattle Genetics. Dr. Pusztai disclosed relationships with AstraZeneca, Athenex, Almac, Bristol-Myers Squibb, Biotheranostics, Clovis, Daiichi, Eisai, Genentech, H2Bio, H3 Biomedicine, Immunomedics, Merck, Novartis, Pfizer, Pieris, Radius Health, Syndax, and Seattle Genetics,.
The findings were reported at the 2020 San Antonio Breast Cancer Symposium.
“In early luminal breast cancer, optimal patient selection for omission of adjuvant chemotherapy, particularly in patients with one to three involved lymph nodes, is still unclear,” noted principal investigator Nadia Harbeck, MD, PhD, of the University of Munich.
Successive trials have used nodal status, genomic risk scores, and response to preoperative therapy to home in on subsets of women for whom this practice is safe.
The ADAPT HR+/HER2– trial is a phase 3 trial that enrolled 5,625 patients with luminal (hormone receptor–positive, HER2-negative) early breast cancer who were candidates for adjuvant chemotherapy based on conventional criteria.
The trial combined a static biomarker – Oncotype Dx recurrence score (RS) in the baseline core biopsy – and a dynamic biomarker – Ki-67 response to a 3-week course of preoperative endocrine therapy – to personalize adjuvant therapy.
At SABCS 2020, Dr. Harbeck reported results for 2,290 patients having zero to three involved lymph nodes: 868 patients with RS 0-11 and 1,422 patients with RS 12-25 who had a response to brief preoperative endocrine therapy (a Ki-67 fraction ≤10% at surgery). All were treated with endocrine therapy alone as adjuvant therapy.
Similar outcomes
The median follow-up was 60 months. The 5-year rate of invasive disease–free survival was 93.9% for the group with RS 0-11 and 92.6% for the group with RS 12-25 and a response to the preoperative endocrine therapy.
The study met its primary endpoint, as the lower limit of the 95% confidence interval for the difference between groups of –3.3% fell just within the predefined margin of –3.3% or less for noninferiority (P = .05).
The groups also had similarly “excellent” distant disease–free survival (96.3% for RS 0-11 and 95.6% for RS 12-25; P = .247) and overall survival (98.0% for RS 0-11 and 97.3% for RS 12-25; P = .160), Dr. Harbeck reported.
The similar distant disease–free survival was consistent regardless of whether women were younger or older than 50 years and regardless of whether women had involved nodes or not.
In multivariate analysis, women had greater risk of distant disease–free survival events if they had three positive lymph nodes versus zero to two (hazard ratio, 3.40) or a pathologic T stage of 2-4 versus 0-1 (HR, 2.24), whereas risk fell with increasing baseline progesterone receptor expression (HR, 0.92).
“Neither patient age nor study arm were prognostic factors for patient outcome,” Dr. Harbeck noted.
In stratified analysis, the negative impact of having three positive nodes was seen only in the group with RS 12-25 and response to preoperative endocrine therapy, suggesting this subgroup may not be good candidates for omission of chemotherapy, she said.
Applying results to practice
“In luminal early breast cancer, the following patients – irrespective of their age – can safely be treated by endocrine therapy alone: patients with zero to three involved lymph nodes and recurrence score 0-11, and those with limited nodal burden (zero to two lymph nodes), recurrence score 12-25, and endocrine response after short preoperative endocrine therapy,” Dr. Harbeck summarized.
“Oncotype Dx testing can spare chemotherapy for the majority of patients with up to three involved lymph nodes. Dynamic Ki-67 response testing is feasible in clinical routine and complements baseline risk assessment to define patient selection for therapy deescalation or escalation,” she added.
The investigators have used the trial’s data to develop an algorithm for predicting the probability of response to short-course preoperative endocrine therapy that is available free of charge online (www.enrep.info).
“This may support everyday clinical decision-making in luminal early breast cancer; for example, whether to start a short period of preoperative endocrine therapy at all, and whether to rely on adjuvant endocrine therapy alone, but also in times like these, whether it’s safe to delay surgery by putting patients on prolonged preoperative endocrine therapy if surgical resources are scarce,” Dr. Harbeck commented.
Her clinic is now recruiting patients for the ADAPT Cycle trial, which is testing an endocrine-based approach with a CDK4/6 inhibitor versus chemotherapy in patients who are not candidates for adjuvant endocrine therapy alone. Therefore, all eligible patients receive the short course of endocrine therapy up front as the standard.
“But if you don’t have a trial, what are you going to do on Monday morning? Please let your patient know whether her tumor is endocrine responsive by doing this 3-week preoperative endocrine therapy,” Dr. Harbeck recommended. “It’s easy to do, you can schedule your surgeries better, and in patients with up to three lymph nodes, it helps with your decision-making, not just in the postmenopausal patients but also in the premenopausal patients, regarding whether they can forgo chemotherapy.”
Findings in context
More than 75% of ADAPT patients with RS 12-25 had a response to short-course endocrine therapy, noted invited discussant Lajos Pusztai, MD, DPhil, of the Yale Cancer Center in New Haven, Conn.
“This implies that the endocrine challenge is not informative for most patients,” he said, adding that a related question is whether the 25% of patients who did not have a response and were therefore given chemotherapy benefited from that therapy.
Dr. Pusztai cautioned that, among patients in the group with RS 12-25 who had a response to preoperative endocrine therapy, certain subgroups were fairly or very small: those aged 50 years or younger (330 patients) and those with two or three positive nodes (75 and 22 patients, respectively).
And collective findings of the similar but much larger TAILORx trial and RxPONDER trial (also reported at SABCS 2020) do suggest a benefit of chemotherapy in younger women, regardless of the number of positive nodes.
“Selection of [estrogen receptor]–positive patients with zero to three lymph nodes for adjuvant chemotherapy currently should be based on age and baseline recurrence score or a similar validated molecular assay,” Dr. Pusztai recommended. “TAILORx results guide us in regard to the use of the recurrence score in node-negative patients with a recurrence score of less than 26, and the recently presented RxPONDER results provide evidence for the use of recurrence score in patients with one to three positive nodes with a recurrence score in the range of 0-26. Both of these trials showed benefit in younger women from adjuvant chemotherapy.”
The ADAPT trial was sponsored by Roche, Genomic Health/Exact Sciences, Celgene, Bayer, Teva, and Amgen. Dr. Harbeck disclosed relationships with Agendia, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Lilly, Merck, Novartis, Odonate Therapeutics, Pfizer, Pierre Fabre, Roche/Genentech, Samsung, Sandoz, and Seattle Genetics. Dr. Pusztai disclosed relationships with AstraZeneca, Athenex, Almac, Bristol-Myers Squibb, Biotheranostics, Clovis, Daiichi, Eisai, Genentech, H2Bio, H3 Biomedicine, Immunomedics, Merck, Novartis, Pfizer, Pieris, Radius Health, Syndax, and Seattle Genetics,.
The findings were reported at the 2020 San Antonio Breast Cancer Symposium.
“In early luminal breast cancer, optimal patient selection for omission of adjuvant chemotherapy, particularly in patients with one to three involved lymph nodes, is still unclear,” noted principal investigator Nadia Harbeck, MD, PhD, of the University of Munich.
Successive trials have used nodal status, genomic risk scores, and response to preoperative therapy to home in on subsets of women for whom this practice is safe.
The ADAPT HR+/HER2– trial is a phase 3 trial that enrolled 5,625 patients with luminal (hormone receptor–positive, HER2-negative) early breast cancer who were candidates for adjuvant chemotherapy based on conventional criteria.
The trial combined a static biomarker – Oncotype Dx recurrence score (RS) in the baseline core biopsy – and a dynamic biomarker – Ki-67 response to a 3-week course of preoperative endocrine therapy – to personalize adjuvant therapy.
At SABCS 2020, Dr. Harbeck reported results for 2,290 patients having zero to three involved lymph nodes: 868 patients with RS 0-11 and 1,422 patients with RS 12-25 who had a response to brief preoperative endocrine therapy (a Ki-67 fraction ≤10% at surgery). All were treated with endocrine therapy alone as adjuvant therapy.
Similar outcomes
The median follow-up was 60 months. The 5-year rate of invasive disease–free survival was 93.9% for the group with RS 0-11 and 92.6% for the group with RS 12-25 and a response to the preoperative endocrine therapy.
The study met its primary endpoint, as the lower limit of the 95% confidence interval for the difference between groups of –3.3% fell just within the predefined margin of –3.3% or less for noninferiority (P = .05).
The groups also had similarly “excellent” distant disease–free survival (96.3% for RS 0-11 and 95.6% for RS 12-25; P = .247) and overall survival (98.0% for RS 0-11 and 97.3% for RS 12-25; P = .160), Dr. Harbeck reported.
The similar distant disease–free survival was consistent regardless of whether women were younger or older than 50 years and regardless of whether women had involved nodes or not.
In multivariate analysis, women had greater risk of distant disease–free survival events if they had three positive lymph nodes versus zero to two (hazard ratio, 3.40) or a pathologic T stage of 2-4 versus 0-1 (HR, 2.24), whereas risk fell with increasing baseline progesterone receptor expression (HR, 0.92).
“Neither patient age nor study arm were prognostic factors for patient outcome,” Dr. Harbeck noted.
In stratified analysis, the negative impact of having three positive nodes was seen only in the group with RS 12-25 and response to preoperative endocrine therapy, suggesting this subgroup may not be good candidates for omission of chemotherapy, she said.
Applying results to practice
“In luminal early breast cancer, the following patients – irrespective of their age – can safely be treated by endocrine therapy alone: patients with zero to three involved lymph nodes and recurrence score 0-11, and those with limited nodal burden (zero to two lymph nodes), recurrence score 12-25, and endocrine response after short preoperative endocrine therapy,” Dr. Harbeck summarized.
“Oncotype Dx testing can spare chemotherapy for the majority of patients with up to three involved lymph nodes. Dynamic Ki-67 response testing is feasible in clinical routine and complements baseline risk assessment to define patient selection for therapy deescalation or escalation,” she added.
The investigators have used the trial’s data to develop an algorithm for predicting the probability of response to short-course preoperative endocrine therapy that is available free of charge online (www.enrep.info).
“This may support everyday clinical decision-making in luminal early breast cancer; for example, whether to start a short period of preoperative endocrine therapy at all, and whether to rely on adjuvant endocrine therapy alone, but also in times like these, whether it’s safe to delay surgery by putting patients on prolonged preoperative endocrine therapy if surgical resources are scarce,” Dr. Harbeck commented.
Her clinic is now recruiting patients for the ADAPT Cycle trial, which is testing an endocrine-based approach with a CDK4/6 inhibitor versus chemotherapy in patients who are not candidates for adjuvant endocrine therapy alone. Therefore, all eligible patients receive the short course of endocrine therapy up front as the standard.
“But if you don’t have a trial, what are you going to do on Monday morning? Please let your patient know whether her tumor is endocrine responsive by doing this 3-week preoperative endocrine therapy,” Dr. Harbeck recommended. “It’s easy to do, you can schedule your surgeries better, and in patients with up to three lymph nodes, it helps with your decision-making, not just in the postmenopausal patients but also in the premenopausal patients, regarding whether they can forgo chemotherapy.”
Findings in context
More than 75% of ADAPT patients with RS 12-25 had a response to short-course endocrine therapy, noted invited discussant Lajos Pusztai, MD, DPhil, of the Yale Cancer Center in New Haven, Conn.
“This implies that the endocrine challenge is not informative for most patients,” he said, adding that a related question is whether the 25% of patients who did not have a response and were therefore given chemotherapy benefited from that therapy.
Dr. Pusztai cautioned that, among patients in the group with RS 12-25 who had a response to preoperative endocrine therapy, certain subgroups were fairly or very small: those aged 50 years or younger (330 patients) and those with two or three positive nodes (75 and 22 patients, respectively).
And collective findings of the similar but much larger TAILORx trial and RxPONDER trial (also reported at SABCS 2020) do suggest a benefit of chemotherapy in younger women, regardless of the number of positive nodes.
“Selection of [estrogen receptor]–positive patients with zero to three lymph nodes for adjuvant chemotherapy currently should be based on age and baseline recurrence score or a similar validated molecular assay,” Dr. Pusztai recommended. “TAILORx results guide us in regard to the use of the recurrence score in node-negative patients with a recurrence score of less than 26, and the recently presented RxPONDER results provide evidence for the use of recurrence score in patients with one to three positive nodes with a recurrence score in the range of 0-26. Both of these trials showed benefit in younger women from adjuvant chemotherapy.”
The ADAPT trial was sponsored by Roche, Genomic Health/Exact Sciences, Celgene, Bayer, Teva, and Amgen. Dr. Harbeck disclosed relationships with Agendia, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Lilly, Merck, Novartis, Odonate Therapeutics, Pfizer, Pierre Fabre, Roche/Genentech, Samsung, Sandoz, and Seattle Genetics. Dr. Pusztai disclosed relationships with AstraZeneca, Athenex, Almac, Bristol-Myers Squibb, Biotheranostics, Clovis, Daiichi, Eisai, Genentech, H2Bio, H3 Biomedicine, Immunomedics, Merck, Novartis, Pfizer, Pieris, Radius Health, Syndax, and Seattle Genetics,.
FROM SABCS 2020
Endoscopic CRC resection carries recurrence, mortality risks
After endoscopic resection, high-risk T1 colorectal cancer (CRC) may have a tenfold greater risk of recurrence than low-risk disease, based on a meta-analysis involving more than 5,000 patients.
These findings support personalized, histologically based surveillance strategies following endoscopic resection of T1 CRC, reported lead author Hao Dang of Leiden University Medical Center in the Netherlands, and colleagues.
“With the introduction of population-based screening programs, a growing number of early-invasive colorectal cancers (T1 CRCs) are detected and treated with local endoscopic resection,” the investigators wrote in Clinical Gastroenterology and Hepatology.
Success with this approach, however, depends upon accurate risk recurrence data, which have been lacking.
Joseph Feuerstein, MD, of the department of medicine at Harvard Medical School and associate clinical chief of gastroenterology at Beth Israel Deaconess Medical Center, Boston, said, “While attempting complete resection of an early cancer with a colonoscopy is appealing, given the very low morbidity associated with it, this technique is only advisable if the risk of recurrence is extremely low when comparing [it] to surgical resection.”
In addition to patient selection, accurate recurrence data could also inform postoperative surveillance.
“To determine the optimal frequency and method of surveillance, it is important to know how often, and at which moments in follow-up local or distant CRC recurrences exactly occur,” wrote Mr. Dang and colleagues. “However, for endoscopically treated T1 CRC patients, the definite answers to these questions have not yet been provided.”
To find answers, Mr. Dang and colleagues conducted a meta-analysis involving 71 studies and 5,167 patients with endoscopically treated T1 CRC. The primary outcome was cumulative incidence and time pattern of CRC recurrence. Data were further characterized by local and/or distant metastasis and CRC-specific mortality.
The pooled cumulative incidence of CRC recurrence was 3.3%, with local and distant recurrences occurring at similar, respective rates of 1.9% and 1.6%. Most recurrences (95.6%) occurred within 72 months of endoscopic resection.
Risk-based recurrence analysis revealed a distinct pattern, with high-risk T1 CRCs recurring at a rate of 7.0% (95% confidence interval, 4.9%-9.9%; I2 = 48.1%), compared with just 0.7% for low-risk tumors (95%-CI, 0.4%-1.2%; I2 = 0%). Mortality data emphasized the clinical importance of this disparity, as the CRC-related mortality rate was 1.7% across the entire population, versus 40.8% among patients with recurrence.
“Our meta-analysis provides quantitative measures of relevant follow-up outcomes, which can form the basis for evidence-based surveillance recommendations for endoscopically treated T1 CRC patients,” the investigators concluded.
According to Dr. Feuerstein, the findings highlight the importance of surveillance after endoscopic resection of CRC while adding clarity to appropriate timing.
“Current guidelines recommend a colonoscopy following a colon cancer diagnosis at 1 year and then 3 years and then every 5 years,” Dr. Feuerstein said. “Adhering to these guidelines would likely identify most cases of recurrence early on within the 72-month window identified in this study.” He noted that “high-risk T1 CRC should probably be monitored more aggressively.”
Anoop Prabhu, MD, of the department of medicine at the University of Michigan Medical Center and director of endoscopy at Ann Arbor Veterans Affairs Medical Center, drew similar conclusions from the findings, noting that “tumor histology appears to be a powerful risk-stratification tool for subsequent surveillance.”
“One of the most important take-home messages from this paper is that, in those patients with low-risk, endoscopically resected colon cancer, surveillance with a colonoscopy in 1 year (as opposed to more intense endoscopic or radiographic surveillance) is likely more than adequate and can save unnecessary testing,” Dr. Prabhu said.
To build upon these findings, Dr. Prabhu suggested that upcoming studies could directly compare different management pathways.
“A potential area for future research would be a cost-effectiveness analysis of competing surveillance strategies after upfront endoscopic resection, with a particular focus on cancer-specific survival,” he said.
The investigators disclosed relationships with Boston Scientific, Cook Medical, and Medtronics. Dr. Feuerstein and Dr. Prabhu reported no relevant conflicts of interest.
After endoscopic resection, high-risk T1 colorectal cancer (CRC) may have a tenfold greater risk of recurrence than low-risk disease, based on a meta-analysis involving more than 5,000 patients.
These findings support personalized, histologically based surveillance strategies following endoscopic resection of T1 CRC, reported lead author Hao Dang of Leiden University Medical Center in the Netherlands, and colleagues.
“With the introduction of population-based screening programs, a growing number of early-invasive colorectal cancers (T1 CRCs) are detected and treated with local endoscopic resection,” the investigators wrote in Clinical Gastroenterology and Hepatology.
Success with this approach, however, depends upon accurate risk recurrence data, which have been lacking.
Joseph Feuerstein, MD, of the department of medicine at Harvard Medical School and associate clinical chief of gastroenterology at Beth Israel Deaconess Medical Center, Boston, said, “While attempting complete resection of an early cancer with a colonoscopy is appealing, given the very low morbidity associated with it, this technique is only advisable if the risk of recurrence is extremely low when comparing [it] to surgical resection.”
In addition to patient selection, accurate recurrence data could also inform postoperative surveillance.
“To determine the optimal frequency and method of surveillance, it is important to know how often, and at which moments in follow-up local or distant CRC recurrences exactly occur,” wrote Mr. Dang and colleagues. “However, for endoscopically treated T1 CRC patients, the definite answers to these questions have not yet been provided.”
To find answers, Mr. Dang and colleagues conducted a meta-analysis involving 71 studies and 5,167 patients with endoscopically treated T1 CRC. The primary outcome was cumulative incidence and time pattern of CRC recurrence. Data were further characterized by local and/or distant metastasis and CRC-specific mortality.
The pooled cumulative incidence of CRC recurrence was 3.3%, with local and distant recurrences occurring at similar, respective rates of 1.9% and 1.6%. Most recurrences (95.6%) occurred within 72 months of endoscopic resection.
Risk-based recurrence analysis revealed a distinct pattern, with high-risk T1 CRCs recurring at a rate of 7.0% (95% confidence interval, 4.9%-9.9%; I2 = 48.1%), compared with just 0.7% for low-risk tumors (95%-CI, 0.4%-1.2%; I2 = 0%). Mortality data emphasized the clinical importance of this disparity, as the CRC-related mortality rate was 1.7% across the entire population, versus 40.8% among patients with recurrence.
“Our meta-analysis provides quantitative measures of relevant follow-up outcomes, which can form the basis for evidence-based surveillance recommendations for endoscopically treated T1 CRC patients,” the investigators concluded.
According to Dr. Feuerstein, the findings highlight the importance of surveillance after endoscopic resection of CRC while adding clarity to appropriate timing.
“Current guidelines recommend a colonoscopy following a colon cancer diagnosis at 1 year and then 3 years and then every 5 years,” Dr. Feuerstein said. “Adhering to these guidelines would likely identify most cases of recurrence early on within the 72-month window identified in this study.” He noted that “high-risk T1 CRC should probably be monitored more aggressively.”
Anoop Prabhu, MD, of the department of medicine at the University of Michigan Medical Center and director of endoscopy at Ann Arbor Veterans Affairs Medical Center, drew similar conclusions from the findings, noting that “tumor histology appears to be a powerful risk-stratification tool for subsequent surveillance.”
“One of the most important take-home messages from this paper is that, in those patients with low-risk, endoscopically resected colon cancer, surveillance with a colonoscopy in 1 year (as opposed to more intense endoscopic or radiographic surveillance) is likely more than adequate and can save unnecessary testing,” Dr. Prabhu said.
To build upon these findings, Dr. Prabhu suggested that upcoming studies could directly compare different management pathways.
“A potential area for future research would be a cost-effectiveness analysis of competing surveillance strategies after upfront endoscopic resection, with a particular focus on cancer-specific survival,” he said.
The investigators disclosed relationships with Boston Scientific, Cook Medical, and Medtronics. Dr. Feuerstein and Dr. Prabhu reported no relevant conflicts of interest.
After endoscopic resection, high-risk T1 colorectal cancer (CRC) may have a tenfold greater risk of recurrence than low-risk disease, based on a meta-analysis involving more than 5,000 patients.
These findings support personalized, histologically based surveillance strategies following endoscopic resection of T1 CRC, reported lead author Hao Dang of Leiden University Medical Center in the Netherlands, and colleagues.
“With the introduction of population-based screening programs, a growing number of early-invasive colorectal cancers (T1 CRCs) are detected and treated with local endoscopic resection,” the investigators wrote in Clinical Gastroenterology and Hepatology.
Success with this approach, however, depends upon accurate risk recurrence data, which have been lacking.
Joseph Feuerstein, MD, of the department of medicine at Harvard Medical School and associate clinical chief of gastroenterology at Beth Israel Deaconess Medical Center, Boston, said, “While attempting complete resection of an early cancer with a colonoscopy is appealing, given the very low morbidity associated with it, this technique is only advisable if the risk of recurrence is extremely low when comparing [it] to surgical resection.”
In addition to patient selection, accurate recurrence data could also inform postoperative surveillance.
“To determine the optimal frequency and method of surveillance, it is important to know how often, and at which moments in follow-up local or distant CRC recurrences exactly occur,” wrote Mr. Dang and colleagues. “However, for endoscopically treated T1 CRC patients, the definite answers to these questions have not yet been provided.”
To find answers, Mr. Dang and colleagues conducted a meta-analysis involving 71 studies and 5,167 patients with endoscopically treated T1 CRC. The primary outcome was cumulative incidence and time pattern of CRC recurrence. Data were further characterized by local and/or distant metastasis and CRC-specific mortality.
The pooled cumulative incidence of CRC recurrence was 3.3%, with local and distant recurrences occurring at similar, respective rates of 1.9% and 1.6%. Most recurrences (95.6%) occurred within 72 months of endoscopic resection.
Risk-based recurrence analysis revealed a distinct pattern, with high-risk T1 CRCs recurring at a rate of 7.0% (95% confidence interval, 4.9%-9.9%; I2 = 48.1%), compared with just 0.7% for low-risk tumors (95%-CI, 0.4%-1.2%; I2 = 0%). Mortality data emphasized the clinical importance of this disparity, as the CRC-related mortality rate was 1.7% across the entire population, versus 40.8% among patients with recurrence.
“Our meta-analysis provides quantitative measures of relevant follow-up outcomes, which can form the basis for evidence-based surveillance recommendations for endoscopically treated T1 CRC patients,” the investigators concluded.
According to Dr. Feuerstein, the findings highlight the importance of surveillance after endoscopic resection of CRC while adding clarity to appropriate timing.
“Current guidelines recommend a colonoscopy following a colon cancer diagnosis at 1 year and then 3 years and then every 5 years,” Dr. Feuerstein said. “Adhering to these guidelines would likely identify most cases of recurrence early on within the 72-month window identified in this study.” He noted that “high-risk T1 CRC should probably be monitored more aggressively.”
Anoop Prabhu, MD, of the department of medicine at the University of Michigan Medical Center and director of endoscopy at Ann Arbor Veterans Affairs Medical Center, drew similar conclusions from the findings, noting that “tumor histology appears to be a powerful risk-stratification tool for subsequent surveillance.”
“One of the most important take-home messages from this paper is that, in those patients with low-risk, endoscopically resected colon cancer, surveillance with a colonoscopy in 1 year (as opposed to more intense endoscopic or radiographic surveillance) is likely more than adequate and can save unnecessary testing,” Dr. Prabhu said.
To build upon these findings, Dr. Prabhu suggested that upcoming studies could directly compare different management pathways.
“A potential area for future research would be a cost-effectiveness analysis of competing surveillance strategies after upfront endoscopic resection, with a particular focus on cancer-specific survival,” he said.
The investigators disclosed relationships with Boston Scientific, Cook Medical, and Medtronics. Dr. Feuerstein and Dr. Prabhu reported no relevant conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Independent physicians finally get vaccine for selves, but not patients
Physicians unaffiliated with health care systems continue to have difficulties obtaining COVID-19 vaccinations for themselves and their staffs, but that challenge appears to be fading in some states. Yet, in many places, primary care physicians (PCPs) still aren’t being enlisted in the national vaccination effort, despite their numbers and their relationships with patients.
In the first few weeks after the Pfizer and Moderna vaccines received emergency-use authorizations from the Food and Drug Administration, they were distributed mostly to hospitals, pharmacies, and long-term care facilities. Naturally, the hospitals and health care systems vaccinated their own staffs and employed physicians first.
So, even though the guidelines from the Centers for Disease Control and Prevention specify that all frontline health care workers should be included in the first vaccination group, many non–hospital-affiliated private practices have been left out in the cold. Non–patient-facing hospital staff members in some facilities, as well as first responders such as police officers and firefighters, have taken precedence over independent primary care physicians.
In Florida, residents older than 65 years were invited to get vaccinated before some physicians had received shots, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, said in an interview.
While the Department of Health & Human Services is now telling states to give vaccinations to everyone over 65, that wasn’t the case back then.
Community doctors in some areas are still finding it hard to get vaccinated or even find out how to get shots. Yul Ejnes, MD, an internist and partner in Coastal Medical, an independent medical group based in Cranston, R.I., said in an interview that he and his practice staff haven’t been vaccinated, while the staffs of local hospitals have received their shots.
In response to repeated inquiries from his group, he said, the state health department recently said independent practice staffs will start getting vaccinated the week of Jan. 25.
Dr. Ejnes said he understood why hospital personnel went first: Hospitals have the necessary infrastructure, “and the staff in the emergency department and the ICU are caring for the sickest of the sick.”
For primary care doctors like himself who don’t work for the hospital, he said, “I don’t think an infrastructure to get us the vaccine in a timely manner was developed – or if it was developed, it hasn’t been communicated to us.”
Nevertheless, Dr. Ejnes stressed that primary care physicians in the community are just as vulnerable to the coronavirus as hospital clinicians. “We’re seeing patients who have COVID but don’t know they have it. I’m seeing 15 patients a day, and we screen them – as everyone else does – for symptoms and contact and travel, and check their temp,” he said. “But not a day goes by that one of the clinicians in this office doesn’t get a phone call from a patient who was seen a day or 2 earlier to tell them it turns out they were COVID positive. I’m spending 15 minutes in a 100–sq ft room with a patient for a routine visit. And as much as we’re masking and gloving and wearing eye protection, I wouldn’t consider us to be at low risk, especially with the high prevalence of disease.”
In some other states, the situation seems to be improving. Ada Stewart, MD, president of the American Academy of Family Physicians, said that she and her colleagues in a community health center in Columbia, S.C., are in the process of being vaccinated. She got her own shot Jan. 6 at a local hospital.
Her clinic’s staff hadn’t been vaccinated earlier, she said, because nobody in the practice knew the contact person at the hospital who could help access the vaccine doses. Other independent practices in her state are now getting vaccinated, she said, after Gov. Henry McMaster of South Carolina ordered that all health care providers in the top priority category be inoculated by Jan. 15. “At this point, the issues have been diminished.”
However, Dr. Stewart added, independent doctors in some states are still unable to get their shots. AAFP state chapters, as well as the national organization, are trying to persuade governors to ensure all of these physicians are vaccinated. “We’re trying to make sure that the voices of physicians not affiliated with health systems are being heard,” she said.
Lucky shot for doctor
David Boles, DO, a family doctor in Clarksville, Tenn., was able to get his first dose of vaccine just before Christmas, he said in an interview, because he was medical director of a hospice that had received vaccine doses for first responders. When some firefighters and police officers failed to show up for their appointments, the hospice called him and said he had 45 minutes to get to the site if he wanted to be vaccinated.
In early January, his colleagues and staff were also vaccinated, he said, after they were notified of their eligibility as frontline health care workers.
Dr. Boles agreed with Dr. Ejnes that community physicians and nurses are as much at risk as hospital clinicians, except for those intubating patients in the ICU. They may be even more vulnerable, he added, because they have less personal protective equipment than hospital doctors and nurses.
Jennifer Brull, MD, a family physician in Plainville, Kan., said there have been plenty of COVID-19 cases in her small rural community, and the local critical access hospital nearly ran out of beds at one point. Through a collaborative relationship among her clinic (the lone one in the area), the hospital, and the county health department, nearly every frontline health care worker has been vaccinated, and most clinicians in her group have gotten their second doses.
Both the hospital and the health department received vaccine supplies, she said, and everyone in the high-priority category was offered shots. So far, about 170 health care workers have been vaccinated, and only a few declined. More than 300 other people – most of them essential non–health care workers and people older than 65 – have signed up for the next round of shots.
Expanding vaccination effort
Dr. Brull’s practice is the exception among private medical groups around the country. Mr. Gilberg said the MGMA is “concerned that independent practices are playing second fiddle because they’ve been left behind.” Physicians and patient-facing staff in private groups should be getting vaccinated before hospital information technology workers and other non–patient-facing staffers.
Medical practices also can and should play a much bigger role in the overall vaccination effort. Mr. Gilberg has spoken to leaders of several large primary care groups “that have the freezers [for vaccines] and the capacity but haven’t been folded into the distribution plan, especially if they’re not part of the hospital system.”
While hospitals have the storage, he said, they’re not set up to distribute vaccines throughout their communities. “Most health care in this country is delivered outside of the hospital setting. That’s how you’re going to get people vaccinated.”
Ironically, he added, “the same PCPs that are having trouble getting themselves and their staffs vaccinated would be the physicians who could help with vaccine distribution.”
Dr. Brull’s clinic stands ready to help the hospital and health department vaccinate the local population. When sufficient vaccine supplies arrive, she said, she envisioned the doctors and staff administering 200-400 shots per day on Saturdays or weekends.
Dr. Brull was the exception – the other physicians interviewed hadn’t been invited to participate in vaccination efforts.
Dr. Ejnes said his group is capable of vaccinating its patients if it uses the Moderna vaccine, which doesn’t require a super-cold freezer. There are logistical challenges, including social distancing and finding space to observe vaccinated patients for 15 minutes after their shots, he noted. “We’re ready and willing, but realistic about how much we’ll be able to do in this effort.”
The fact that doctors haven’t been enlisted yet in this campaign speaks volumes about “the neglect of the public health infrastructure,” Dr. Ejnes said. “We’re not mobilizing as quickly as we should.”
Alternative routes
Dr. Boles’ group has a refrigerator for pediatric vaccines, which could be used to store the Moderna vaccine, he noted. Shots could be administered to patients in their cars in the parking lot, and they could wait for a while afterward until a nurse came out to verify they were okay.
Mass vaccination sites might also be deployed, as Los Angeles is doing with Dodger Stadium, and physicians could take shifts there in their spare time, Dr. Boles said. But for right now, he views pharmacies as the primary venues for community vaccination.
Of course, the number of pharmacists and pharmacy-employed advanced practice nurses is tiny, compared with the number of primary care doctors, mid-level practitioners, and nurses in ambulatory care practices. Moreover, Mr. Gilberg said, practices know from their electronic health records which patients are most at risk and should be vaccinated first. “Walgreens and CVS don’t know that.”
Physicians should also take the lead in vaccinations because of their patient relationships, he noted. “They can help educate [vaccine-hesitant] patients on why it’s important and dispel some of the rumors and the misinformation that has been politicized. That’s why we should engage physicians in an outpatient setting. And we have to vaccinate them and their staffs. Otherwise, we’re never going to get this rollout underway.”
Dr. Stewart agreed. “We are really the foundation of how we’re going to accomplish this. Most folks are seen by a primary care physician. We touch millions of lives,” she said. “We’re part of the community. Our patients trust us. We’re out there doing it already. We’re doing prevention, giving flu shots, and we’re trying to encourage people to get the COVID vaccine.”
A version of this article first appeared on Medscape.com.
Physicians unaffiliated with health care systems continue to have difficulties obtaining COVID-19 vaccinations for themselves and their staffs, but that challenge appears to be fading in some states. Yet, in many places, primary care physicians (PCPs) still aren’t being enlisted in the national vaccination effort, despite their numbers and their relationships with patients.
In the first few weeks after the Pfizer and Moderna vaccines received emergency-use authorizations from the Food and Drug Administration, they were distributed mostly to hospitals, pharmacies, and long-term care facilities. Naturally, the hospitals and health care systems vaccinated their own staffs and employed physicians first.
So, even though the guidelines from the Centers for Disease Control and Prevention specify that all frontline health care workers should be included in the first vaccination group, many non–hospital-affiliated private practices have been left out in the cold. Non–patient-facing hospital staff members in some facilities, as well as first responders such as police officers and firefighters, have taken precedence over independent primary care physicians.
In Florida, residents older than 65 years were invited to get vaccinated before some physicians had received shots, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, said in an interview.
While the Department of Health & Human Services is now telling states to give vaccinations to everyone over 65, that wasn’t the case back then.
Community doctors in some areas are still finding it hard to get vaccinated or even find out how to get shots. Yul Ejnes, MD, an internist and partner in Coastal Medical, an independent medical group based in Cranston, R.I., said in an interview that he and his practice staff haven’t been vaccinated, while the staffs of local hospitals have received their shots.
In response to repeated inquiries from his group, he said, the state health department recently said independent practice staffs will start getting vaccinated the week of Jan. 25.
Dr. Ejnes said he understood why hospital personnel went first: Hospitals have the necessary infrastructure, “and the staff in the emergency department and the ICU are caring for the sickest of the sick.”
For primary care doctors like himself who don’t work for the hospital, he said, “I don’t think an infrastructure to get us the vaccine in a timely manner was developed – or if it was developed, it hasn’t been communicated to us.”
Nevertheless, Dr. Ejnes stressed that primary care physicians in the community are just as vulnerable to the coronavirus as hospital clinicians. “We’re seeing patients who have COVID but don’t know they have it. I’m seeing 15 patients a day, and we screen them – as everyone else does – for symptoms and contact and travel, and check their temp,” he said. “But not a day goes by that one of the clinicians in this office doesn’t get a phone call from a patient who was seen a day or 2 earlier to tell them it turns out they were COVID positive. I’m spending 15 minutes in a 100–sq ft room with a patient for a routine visit. And as much as we’re masking and gloving and wearing eye protection, I wouldn’t consider us to be at low risk, especially with the high prevalence of disease.”
In some other states, the situation seems to be improving. Ada Stewart, MD, president of the American Academy of Family Physicians, said that she and her colleagues in a community health center in Columbia, S.C., are in the process of being vaccinated. She got her own shot Jan. 6 at a local hospital.
Her clinic’s staff hadn’t been vaccinated earlier, she said, because nobody in the practice knew the contact person at the hospital who could help access the vaccine doses. Other independent practices in her state are now getting vaccinated, she said, after Gov. Henry McMaster of South Carolina ordered that all health care providers in the top priority category be inoculated by Jan. 15. “At this point, the issues have been diminished.”
However, Dr. Stewart added, independent doctors in some states are still unable to get their shots. AAFP state chapters, as well as the national organization, are trying to persuade governors to ensure all of these physicians are vaccinated. “We’re trying to make sure that the voices of physicians not affiliated with health systems are being heard,” she said.
Lucky shot for doctor
David Boles, DO, a family doctor in Clarksville, Tenn., was able to get his first dose of vaccine just before Christmas, he said in an interview, because he was medical director of a hospice that had received vaccine doses for first responders. When some firefighters and police officers failed to show up for their appointments, the hospice called him and said he had 45 minutes to get to the site if he wanted to be vaccinated.
In early January, his colleagues and staff were also vaccinated, he said, after they were notified of their eligibility as frontline health care workers.
Dr. Boles agreed with Dr. Ejnes that community physicians and nurses are as much at risk as hospital clinicians, except for those intubating patients in the ICU. They may be even more vulnerable, he added, because they have less personal protective equipment than hospital doctors and nurses.
Jennifer Brull, MD, a family physician in Plainville, Kan., said there have been plenty of COVID-19 cases in her small rural community, and the local critical access hospital nearly ran out of beds at one point. Through a collaborative relationship among her clinic (the lone one in the area), the hospital, and the county health department, nearly every frontline health care worker has been vaccinated, and most clinicians in her group have gotten their second doses.
Both the hospital and the health department received vaccine supplies, she said, and everyone in the high-priority category was offered shots. So far, about 170 health care workers have been vaccinated, and only a few declined. More than 300 other people – most of them essential non–health care workers and people older than 65 – have signed up for the next round of shots.
Expanding vaccination effort
Dr. Brull’s practice is the exception among private medical groups around the country. Mr. Gilberg said the MGMA is “concerned that independent practices are playing second fiddle because they’ve been left behind.” Physicians and patient-facing staff in private groups should be getting vaccinated before hospital information technology workers and other non–patient-facing staffers.
Medical practices also can and should play a much bigger role in the overall vaccination effort. Mr. Gilberg has spoken to leaders of several large primary care groups “that have the freezers [for vaccines] and the capacity but haven’t been folded into the distribution plan, especially if they’re not part of the hospital system.”
While hospitals have the storage, he said, they’re not set up to distribute vaccines throughout their communities. “Most health care in this country is delivered outside of the hospital setting. That’s how you’re going to get people vaccinated.”
Ironically, he added, “the same PCPs that are having trouble getting themselves and their staffs vaccinated would be the physicians who could help with vaccine distribution.”
Dr. Brull’s clinic stands ready to help the hospital and health department vaccinate the local population. When sufficient vaccine supplies arrive, she said, she envisioned the doctors and staff administering 200-400 shots per day on Saturdays or weekends.
Dr. Brull was the exception – the other physicians interviewed hadn’t been invited to participate in vaccination efforts.
Dr. Ejnes said his group is capable of vaccinating its patients if it uses the Moderna vaccine, which doesn’t require a super-cold freezer. There are logistical challenges, including social distancing and finding space to observe vaccinated patients for 15 minutes after their shots, he noted. “We’re ready and willing, but realistic about how much we’ll be able to do in this effort.”
The fact that doctors haven’t been enlisted yet in this campaign speaks volumes about “the neglect of the public health infrastructure,” Dr. Ejnes said. “We’re not mobilizing as quickly as we should.”
Alternative routes
Dr. Boles’ group has a refrigerator for pediatric vaccines, which could be used to store the Moderna vaccine, he noted. Shots could be administered to patients in their cars in the parking lot, and they could wait for a while afterward until a nurse came out to verify they were okay.
Mass vaccination sites might also be deployed, as Los Angeles is doing with Dodger Stadium, and physicians could take shifts there in their spare time, Dr. Boles said. But for right now, he views pharmacies as the primary venues for community vaccination.
Of course, the number of pharmacists and pharmacy-employed advanced practice nurses is tiny, compared with the number of primary care doctors, mid-level practitioners, and nurses in ambulatory care practices. Moreover, Mr. Gilberg said, practices know from their electronic health records which patients are most at risk and should be vaccinated first. “Walgreens and CVS don’t know that.”
Physicians should also take the lead in vaccinations because of their patient relationships, he noted. “They can help educate [vaccine-hesitant] patients on why it’s important and dispel some of the rumors and the misinformation that has been politicized. That’s why we should engage physicians in an outpatient setting. And we have to vaccinate them and their staffs. Otherwise, we’re never going to get this rollout underway.”
Dr. Stewart agreed. “We are really the foundation of how we’re going to accomplish this. Most folks are seen by a primary care physician. We touch millions of lives,” she said. “We’re part of the community. Our patients trust us. We’re out there doing it already. We’re doing prevention, giving flu shots, and we’re trying to encourage people to get the COVID vaccine.”
A version of this article first appeared on Medscape.com.
Physicians unaffiliated with health care systems continue to have difficulties obtaining COVID-19 vaccinations for themselves and their staffs, but that challenge appears to be fading in some states. Yet, in many places, primary care physicians (PCPs) still aren’t being enlisted in the national vaccination effort, despite their numbers and their relationships with patients.
In the first few weeks after the Pfizer and Moderna vaccines received emergency-use authorizations from the Food and Drug Administration, they were distributed mostly to hospitals, pharmacies, and long-term care facilities. Naturally, the hospitals and health care systems vaccinated their own staffs and employed physicians first.
So, even though the guidelines from the Centers for Disease Control and Prevention specify that all frontline health care workers should be included in the first vaccination group, many non–hospital-affiliated private practices have been left out in the cold. Non–patient-facing hospital staff members in some facilities, as well as first responders such as police officers and firefighters, have taken precedence over independent primary care physicians.
In Florida, residents older than 65 years were invited to get vaccinated before some physicians had received shots, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, said in an interview.
While the Department of Health & Human Services is now telling states to give vaccinations to everyone over 65, that wasn’t the case back then.
Community doctors in some areas are still finding it hard to get vaccinated or even find out how to get shots. Yul Ejnes, MD, an internist and partner in Coastal Medical, an independent medical group based in Cranston, R.I., said in an interview that he and his practice staff haven’t been vaccinated, while the staffs of local hospitals have received their shots.
In response to repeated inquiries from his group, he said, the state health department recently said independent practice staffs will start getting vaccinated the week of Jan. 25.
Dr. Ejnes said he understood why hospital personnel went first: Hospitals have the necessary infrastructure, “and the staff in the emergency department and the ICU are caring for the sickest of the sick.”
For primary care doctors like himself who don’t work for the hospital, he said, “I don’t think an infrastructure to get us the vaccine in a timely manner was developed – or if it was developed, it hasn’t been communicated to us.”
Nevertheless, Dr. Ejnes stressed that primary care physicians in the community are just as vulnerable to the coronavirus as hospital clinicians. “We’re seeing patients who have COVID but don’t know they have it. I’m seeing 15 patients a day, and we screen them – as everyone else does – for symptoms and contact and travel, and check their temp,” he said. “But not a day goes by that one of the clinicians in this office doesn’t get a phone call from a patient who was seen a day or 2 earlier to tell them it turns out they were COVID positive. I’m spending 15 minutes in a 100–sq ft room with a patient for a routine visit. And as much as we’re masking and gloving and wearing eye protection, I wouldn’t consider us to be at low risk, especially with the high prevalence of disease.”
In some other states, the situation seems to be improving. Ada Stewart, MD, president of the American Academy of Family Physicians, said that she and her colleagues in a community health center in Columbia, S.C., are in the process of being vaccinated. She got her own shot Jan. 6 at a local hospital.
Her clinic’s staff hadn’t been vaccinated earlier, she said, because nobody in the practice knew the contact person at the hospital who could help access the vaccine doses. Other independent practices in her state are now getting vaccinated, she said, after Gov. Henry McMaster of South Carolina ordered that all health care providers in the top priority category be inoculated by Jan. 15. “At this point, the issues have been diminished.”
However, Dr. Stewart added, independent doctors in some states are still unable to get their shots. AAFP state chapters, as well as the national organization, are trying to persuade governors to ensure all of these physicians are vaccinated. “We’re trying to make sure that the voices of physicians not affiliated with health systems are being heard,” she said.
Lucky shot for doctor
David Boles, DO, a family doctor in Clarksville, Tenn., was able to get his first dose of vaccine just before Christmas, he said in an interview, because he was medical director of a hospice that had received vaccine doses for first responders. When some firefighters and police officers failed to show up for their appointments, the hospice called him and said he had 45 minutes to get to the site if he wanted to be vaccinated.
In early January, his colleagues and staff were also vaccinated, he said, after they were notified of their eligibility as frontline health care workers.
Dr. Boles agreed with Dr. Ejnes that community physicians and nurses are as much at risk as hospital clinicians, except for those intubating patients in the ICU. They may be even more vulnerable, he added, because they have less personal protective equipment than hospital doctors and nurses.
Jennifer Brull, MD, a family physician in Plainville, Kan., said there have been plenty of COVID-19 cases in her small rural community, and the local critical access hospital nearly ran out of beds at one point. Through a collaborative relationship among her clinic (the lone one in the area), the hospital, and the county health department, nearly every frontline health care worker has been vaccinated, and most clinicians in her group have gotten their second doses.
Both the hospital and the health department received vaccine supplies, she said, and everyone in the high-priority category was offered shots. So far, about 170 health care workers have been vaccinated, and only a few declined. More than 300 other people – most of them essential non–health care workers and people older than 65 – have signed up for the next round of shots.
Expanding vaccination effort
Dr. Brull’s practice is the exception among private medical groups around the country. Mr. Gilberg said the MGMA is “concerned that independent practices are playing second fiddle because they’ve been left behind.” Physicians and patient-facing staff in private groups should be getting vaccinated before hospital information technology workers and other non–patient-facing staffers.
Medical practices also can and should play a much bigger role in the overall vaccination effort. Mr. Gilberg has spoken to leaders of several large primary care groups “that have the freezers [for vaccines] and the capacity but haven’t been folded into the distribution plan, especially if they’re not part of the hospital system.”
While hospitals have the storage, he said, they’re not set up to distribute vaccines throughout their communities. “Most health care in this country is delivered outside of the hospital setting. That’s how you’re going to get people vaccinated.”
Ironically, he added, “the same PCPs that are having trouble getting themselves and their staffs vaccinated would be the physicians who could help with vaccine distribution.”
Dr. Brull’s clinic stands ready to help the hospital and health department vaccinate the local population. When sufficient vaccine supplies arrive, she said, she envisioned the doctors and staff administering 200-400 shots per day on Saturdays or weekends.
Dr. Brull was the exception – the other physicians interviewed hadn’t been invited to participate in vaccination efforts.
Dr. Ejnes said his group is capable of vaccinating its patients if it uses the Moderna vaccine, which doesn’t require a super-cold freezer. There are logistical challenges, including social distancing and finding space to observe vaccinated patients for 15 minutes after their shots, he noted. “We’re ready and willing, but realistic about how much we’ll be able to do in this effort.”
The fact that doctors haven’t been enlisted yet in this campaign speaks volumes about “the neglect of the public health infrastructure,” Dr. Ejnes said. “We’re not mobilizing as quickly as we should.”
Alternative routes
Dr. Boles’ group has a refrigerator for pediatric vaccines, which could be used to store the Moderna vaccine, he noted. Shots could be administered to patients in their cars in the parking lot, and they could wait for a while afterward until a nurse came out to verify they were okay.
Mass vaccination sites might also be deployed, as Los Angeles is doing with Dodger Stadium, and physicians could take shifts there in their spare time, Dr. Boles said. But for right now, he views pharmacies as the primary venues for community vaccination.
Of course, the number of pharmacists and pharmacy-employed advanced practice nurses is tiny, compared with the number of primary care doctors, mid-level practitioners, and nurses in ambulatory care practices. Moreover, Mr. Gilberg said, practices know from their electronic health records which patients are most at risk and should be vaccinated first. “Walgreens and CVS don’t know that.”
Physicians should also take the lead in vaccinations because of their patient relationships, he noted. “They can help educate [vaccine-hesitant] patients on why it’s important and dispel some of the rumors and the misinformation that has been politicized. That’s why we should engage physicians in an outpatient setting. And we have to vaccinate them and their staffs. Otherwise, we’re never going to get this rollout underway.”
Dr. Stewart agreed. “We are really the foundation of how we’re going to accomplish this. Most folks are seen by a primary care physician. We touch millions of lives,” she said. “We’re part of the community. Our patients trust us. We’re out there doing it already. We’re doing prevention, giving flu shots, and we’re trying to encourage people to get the COVID vaccine.”
A version of this article first appeared on Medscape.com.