As 2021 winds down, I reflect on the achievements the rheumatology community has had in the realm of advocacy throughout the year. And there were many: Seven states signed accumulator program bans into law, five states reformed the use of step therapy protocols, Texas passed an innovative “gold carding” law to reduce the burden of prior authorization, and West Virginia passed a rebate pass-through law to directly assist patients with high out-of-pocket costs – the first of its kind in the nation.

Of course, the close of another year also means gearing up for the year ahead. The majority of state legislatures are getting ready to open legislative sessions in the New Year. This means a year of new opportunities and new challenges. As a community, there are some key areas rheumatology will need to focus on during the course of the upcoming year as policy makers return to the business of policy making.

Many in the rheumatology community are aware that the buy and bill acquisition system has come under threat in recent years, mainly from payer mandates to use the alternative white bagging model. In some cases, payers have gone as far as to mandate the practice of “brown bagging,” or home infusion. These practices can endanger patient safety and overall quality of care. A study led by Matthew Baker, MD, of Stanford (Calif.) University found that biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care; specifically, home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after infusion, compared with facility infusions, and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. Additionally, site-of-care research by Paul Fronstin, PhD, at Employee Benefit Research Institute clearly shows that in-office infusion with physician supervision is far more cost effective than hospital and, in some cases, home infusion as well.

Further, the metastasis of these payer mandates is likely to severely limit availability of and access to care. It is unclear whether outpatient infusion, especially in private rheumatology practices, will prove sustainable in a world of white bagging. The net result of an expansion of the white-bagging requirements may well be broad access challenges that inconvenience patients deeply and irresponsibly.

The expansion of these mandates has not come without pushback, and rheumatologists should be prepared to advocate for policy that prohibits payers from mandating the use of white bagging, brown bagging, and home infusion. It is abundantly clear that arguments of safety and cost effectiveness are sufficient grounds for policy makers to curtail the mandatory use of these practices.

Similar to white bagging, another key issue in the year ahead is formulary construction based on the rebate system and proposed policies to address its attendant problems. Propagated by pharmacy benefit managers (PBMs), the rebate-based, or kickback, system of formulary construction often rewards higher-priced drugs with preferred placement regardless of whether they are the best and most affordable medications for our patients. A few states are beginning to address the affordability issue by mandating that the rebate/kickback acquired by the PBM be passed back to the patient at the point of sale. West Virginia passed a first-of-its-kind law to ensure that patients who generate drug rebates benefit from them by requiring that their cost shares are reduced by an amount equivalent to the rebate received by a health plan. This policy does not get at the root of the formulary construction problem, but if it is adopted more broadly across the country, it will deliver direct relief to patients who are struggling with out-of-pocket costs associated with prescription drugs. I anticipate that this will be a prominent issue nationwide during the upcoming year with opportunity for rheumatologists to lend their voices.

Many of the rheumatology community’s longstanding issues persist, and while progress has been made, more work remains to be done. Whether it’s accumulator programs, prior authorization, nonmedical switching, or step therapy, there will be opportunities in almost every state to engage in improving our ability to provide excellent care to our patients.

We tend to be motivated into action when one of these individual issues appear in our own state’s legislature; however, consistency of engagement is also important. While it is important to talk to your legislators when you need them to vote a certain way on a certain bill, scheduling a meeting with them or sending them a message detailing some of the issues that the rheumatology community faces before legislatures return in full swing is equally important to establish the relationship.

By making “rheum for action” now, you’ll have more impact when legislation relevant to our daily work does appear in the state legislatures. You can find your state representatives at the Coalition for State Rheumatology Organization’s Action Center.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

As 2021 winds down, I reflect on the achievements the rheumatology community has had in the realm of advocacy throughout the year. And there were many: Seven states signed accumulator program bans into law, five states reformed the use of step therapy protocols, Texas passed an innovative “gold carding” law to reduce the burden of prior authorization, and West Virginia passed a rebate pass-through law to directly assist patients with high out-of-pocket costs – the first of its kind in the nation.

Of course, the close of another year also means gearing up for the year ahead. The majority of state legislatures are getting ready to open legislative sessions in the New Year. This means a year of new opportunities and new challenges. As a community, there are some key areas rheumatology will need to focus on during the course of the upcoming year as policy makers return to the business of policy making.

Many in the rheumatology community are aware that the buy and bill acquisition system has come under threat in recent years, mainly from payer mandates to use the alternative white bagging model. In some cases, payers have gone as far as to mandate the practice of “brown bagging,” or home infusion. These practices can endanger patient safety and overall quality of care. A study led by Matthew Baker, MD, of Stanford (Calif.) University found that biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care; specifically, home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after infusion, compared with facility infusions, and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. Additionally, site-of-care research by Paul Fronstin, PhD, at Employee Benefit Research Institute clearly shows that in-office infusion with physician supervision is far more cost effective than hospital and, in some cases, home infusion as well.

Further, the metastasis of these payer mandates is likely to severely limit availability of and access to care. It is unclear whether outpatient infusion, especially in private rheumatology practices, will prove sustainable in a world of white bagging. The net result of an expansion of the white-bagging requirements may well be broad access challenges that inconvenience patients deeply and irresponsibly.

The expansion of these mandates has not come without pushback, and rheumatologists should be prepared to advocate for policy that prohibits payers from mandating the use of white bagging, brown bagging, and home infusion. It is abundantly clear that arguments of safety and cost effectiveness are sufficient grounds for policy makers to curtail the mandatory use of these practices.

Similar to white bagging, another key issue in the year ahead is formulary construction based on the rebate system and proposed policies to address its attendant problems. Propagated by pharmacy benefit managers (PBMs), the rebate-based, or kickback, system of formulary construction often rewards higher-priced drugs with preferred placement regardless of whether they are the best and most affordable medications for our patients. A few states are beginning to address the affordability issue by mandating that the rebate/kickback acquired by the PBM be passed back to the patient at the point of sale. West Virginia passed a first-of-its-kind law to ensure that patients who generate drug rebates benefit from them by requiring that their cost shares are reduced by an amount equivalent to the rebate received by a health plan. This policy does not get at the root of the formulary construction problem, but if it is adopted more broadly across the country, it will deliver direct relief to patients who are struggling with out-of-pocket costs associated with prescription drugs. I anticipate that this will be a prominent issue nationwide during the upcoming year with opportunity for rheumatologists to lend their voices.

Many of the rheumatology community’s longstanding issues persist, and while progress has been made, more work remains to be done. Whether it’s accumulator programs, prior authorization, nonmedical switching, or step therapy, there will be opportunities in almost every state to engage in improving our ability to provide excellent care to our patients.

We tend to be motivated into action when one of these individual issues appear in our own state’s legislature; however, consistency of engagement is also important. While it is important to talk to your legislators when you need them to vote a certain way on a certain bill, scheduling a meeting with them or sending them a message detailing some of the issues that the rheumatology community faces before legislatures return in full swing is equally important to establish the relationship.

By making “rheum for action” now, you’ll have more impact when legislation relevant to our daily work does appear in the state legislatures. You can find your state representatives at the Coalition for State Rheumatology Organization’s Action Center.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

As 2021 winds down, I reflect on the achievements the rheumatology community has had in the realm of advocacy throughout the year. And there were many: Seven states signed accumulator program bans into law, five states reformed the use of step therapy protocols, Texas passed an innovative “gold carding” law to reduce the burden of prior authorization, and West Virginia passed a rebate pass-through law to directly assist patients with high out-of-pocket costs – the first of its kind in the nation.

Of course, the close of another year also means gearing up for the year ahead. The majority of state legislatures are getting ready to open legislative sessions in the New Year. This means a year of new opportunities and new challenges. As a community, there are some key areas rheumatology will need to focus on during the course of the upcoming year as policy makers return to the business of policy making.

Many in the rheumatology community are aware that the buy and bill acquisition system has come under threat in recent years, mainly from payer mandates to use the alternative white bagging model. In some cases, payers have gone as far as to mandate the practice of “brown bagging,” or home infusion. These practices can endanger patient safety and overall quality of care. A study led by Matthew Baker, MD, of Stanford (Calif.) University found that biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care; specifically, home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after infusion, compared with facility infusions, and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. Additionally, site-of-care research by Paul Fronstin, PhD, at Employee Benefit Research Institute clearly shows that in-office infusion with physician supervision is far more cost effective than hospital and, in some cases, home infusion as well.

Further, the metastasis of these payer mandates is likely to severely limit availability of and access to care. It is unclear whether outpatient infusion, especially in private rheumatology practices, will prove sustainable in a world of white bagging. The net result of an expansion of the white-bagging requirements may well be broad access challenges that inconvenience patients deeply and irresponsibly.

The expansion of these mandates has not come without pushback, and rheumatologists should be prepared to advocate for policy that prohibits payers from mandating the use of white bagging, brown bagging, and home infusion. It is abundantly clear that arguments of safety and cost effectiveness are sufficient grounds for policy makers to curtail the mandatory use of these practices.

Similar to white bagging, another key issue in the year ahead is formulary construction based on the rebate system and proposed policies to address its attendant problems. Propagated by pharmacy benefit managers (PBMs), the rebate-based, or kickback, system of formulary construction often rewards higher-priced drugs with preferred placement regardless of whether they are the best and most affordable medications for our patients. A few states are beginning to address the affordability issue by mandating that the rebate/kickback acquired by the PBM be passed back to the patient at the point of sale. West Virginia passed a first-of-its-kind law to ensure that patients who generate drug rebates benefit from them by requiring that their cost shares are reduced by an amount equivalent to the rebate received by a health plan. This policy does not get at the root of the formulary construction problem, but if it is adopted more broadly across the country, it will deliver direct relief to patients who are struggling with out-of-pocket costs associated with prescription drugs. I anticipate that this will be a prominent issue nationwide during the upcoming year with opportunity for rheumatologists to lend their voices.

Many of the rheumatology community’s longstanding issues persist, and while progress has been made, more work remains to be done. Whether it’s accumulator programs, prior authorization, nonmedical switching, or step therapy, there will be opportunities in almost every state to engage in improving our ability to provide excellent care to our patients.

We tend to be motivated into action when one of these individual issues appear in our own state’s legislature; however, consistency of engagement is also important. While it is important to talk to your legislators when you need them to vote a certain way on a certain bill, scheduling a meeting with them or sending them a message detailing some of the issues that the rheumatology community faces before legislatures return in full swing is equally important to establish the relationship.

By making “rheum for action” now, you’ll have more impact when legislation relevant to our daily work does appear in the state legislatures. You can find your state representatives at the Coalition for State Rheumatology Organization’s Action Center.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

It remains early days for transcatheter mitral-valve replacement (TMVR) as a minimally invasive way to treat severe, mitral regurgitation (MR), but it’s even earlier days for TMVR as an endovascular procedure. Most of the technique’s limited experience with a dedicated mitral prosthesis has involved transapical delivery.

But now a 15-patient study of transfemoral, transeptal TMVR – with a prosthesis designed for the mitral position and previously tested only transapically – has shown good 30-day results in that MR was essentially abolished with virtually no paravalvular leakage.

Nor were there adverse clinical events such as death, stroke, reintervention, or new need for a pacemaker in any of the high-surgical-risk patients with MR in this feasibility study of the transfemoral Intrepid TMVR System (Medtronic). Implantation failed, however, in one patient who then received a surgical valve via sternotomy.

The current cohort is part of a larger ongoing trial that will track whether patients implanted transfemorally with the Intrepid also show reverse remodeling and good clinical outcomes over at least a year. That study, called APOLLO, is one of several exploring dedicated TMVR valves from different companies, with names like SUMMIT, MISCEND, and TIARA-2.

Currently, TMVR is approved in the United States only using one device designed for the aortic position and only for treating failed surgical mitral bioprostheses in high-risk patients.

If the Intrepid transfemoral system has an Achilles’ heel, at least in the current iteration, it might be its 35 F catheter delivery system that requires surgical access to the femoral vein. Seven of the patients in the small series experienced major bleeding events, including six at the femoral access site, listed as major vascular complications.

Overall, the study’s patients “were extremely sick with a lot of comorbidity. A lot of them had atrial fibrillation, a lot of them were on anticoagulation to start with,” observed Firas Zahr, MD, Oregon Health & Science University, Portland, as part of his presentation of the study at Transcatheter Cardiovascular Therapeutics (TCT) 2021, held virtually as well as onsite in Orlando, Florida.

All had moderate-to-severe, usually primary MR; two thirds of the cohort had been in NYHA class III or IV at baseline, and 40% had been hospitalized for heart failure within the past year. Eight had a history of cardiovascular surgery, and eight had diabetes. Their mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 4.7, Dr. Zahr reported.

“At 30 days, there was a significant improvement in their heart failure classification; the vast majority of the patients were [NYHA] class I and class II,” said Dr. Zahr, who is also lead author on the study’s Nov. 6 publication in JACC: Cardiovascular Interventions.

Observers of the study at TCT 2021 seemed enthusiastic about the study’s results but recognized that TMVR in its current form still has formidable limitations.

“This is clearly an exciting look into the future and very reassuring to a degree, aside from the complications, which are somewhat expected as we go with 30-plus French devices,” Rajiv Tayal, MD, MPH, said at a press conference on the Intrepid study held before Dr. Zahr’s formal presentation. Dr. Tayal is an interventional cardiologist with Valley Health System, Ridgewood, New Jersey, and New York Medical College, Valhalla.

“I think we’ve all learned that transapical [access] is just not a viable procedure for a lot of these patients, and so we’ve got to get to transfemoral,” Susheel K. Kodali, MD, interventional cardiologist at New York-Presbyterian/Columbia University Irving Medical Center, said at the same forum.

A 35 F device “is going to be too big,” he said. However, “it is the first step to iterate to a smaller device.” Dr. Kodali said his center contributed a patient to the study, and he is listed as a coauthor on the publication.

The delivery system’s large profile is only part of the vascular complication issue. Not only did the procedure require surgical cutdown for venous access, but “we were fairly aggressive in anticoagulating these patients with the fear of thrombus formation,” Dr. Zahr said in the discussion following his presentation.

“A postprocedure anticoagulation regimen is recommended within the protocol, but ultimate therapy was left to the discretion of the treating site physician,” the published report states, noting that all 14 patients with successful TMVR were discharged on warfarin. They included 12 who were also put on a single antiplatelet and one given dual antiplatelet therapy on top of the oral anticoagulant.

“One thing that we learned is that we probably should standardize our approach to perioperative anticoagulation,” Dr. Zahr observed. Also, a 29 F sheath for the system is in the works, “and we’re hoping that with smaller sheath size, and hopefully going even to percutaneous, might have an impact on lowering the vascular complications.”

Explanations for the “higher-than-expected vascular complication rate” remains somewhat unclear, agreed an editorial accompanying the study’s publication, “but may include a learning curve with the system, the large introducer sheath, the need for surgical cutdown, and postprocedural anticoagulation.”

For trans-septal TMVR to become a default approach, “venous access will need to be achieved percutaneously and vascular complications need to be infrequent,” contends the editorial, with lead author Mohamad Alkhouli, MD, Mayo Clinic, Rochester, Minn.

“These data provide a glimpse into the future of TMVR. The excellent short-term safety and effectiveness of this still very early-stage procedure represent a major step forward in the field,” they write.

A version of this article first appeared on Medscape.com.

It remains early days for transcatheter mitral-valve replacement (TMVR) as a minimally invasive way to treat severe, mitral regurgitation (MR), but it’s even earlier days for TMVR as an endovascular procedure. Most of the technique’s limited experience with a dedicated mitral prosthesis has involved transapical delivery.

But now a 15-patient study of transfemoral, transeptal TMVR – with a prosthesis designed for the mitral position and previously tested only transapically – has shown good 30-day results in that MR was essentially abolished with virtually no paravalvular leakage.

Nor were there adverse clinical events such as death, stroke, reintervention, or new need for a pacemaker in any of the high-surgical-risk patients with MR in this feasibility study of the transfemoral Intrepid TMVR System (Medtronic). Implantation failed, however, in one patient who then received a surgical valve via sternotomy.

The current cohort is part of a larger ongoing trial that will track whether patients implanted transfemorally with the Intrepid also show reverse remodeling and good clinical outcomes over at least a year. That study, called APOLLO, is one of several exploring dedicated TMVR valves from different companies, with names like SUMMIT, MISCEND, and TIARA-2.

Currently, TMVR is approved in the United States only using one device designed for the aortic position and only for treating failed surgical mitral bioprostheses in high-risk patients.

If the Intrepid transfemoral system has an Achilles’ heel, at least in the current iteration, it might be its 35 F catheter delivery system that requires surgical access to the femoral vein. Seven of the patients in the small series experienced major bleeding events, including six at the femoral access site, listed as major vascular complications.

Overall, the study’s patients “were extremely sick with a lot of comorbidity. A lot of them had atrial fibrillation, a lot of them were on anticoagulation to start with,” observed Firas Zahr, MD, Oregon Health & Science University, Portland, as part of his presentation of the study at Transcatheter Cardiovascular Therapeutics (TCT) 2021, held virtually as well as onsite in Orlando, Florida.

All had moderate-to-severe, usually primary MR; two thirds of the cohort had been in NYHA class III or IV at baseline, and 40% had been hospitalized for heart failure within the past year. Eight had a history of cardiovascular surgery, and eight had diabetes. Their mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 4.7, Dr. Zahr reported.

“At 30 days, there was a significant improvement in their heart failure classification; the vast majority of the patients were [NYHA] class I and class II,” said Dr. Zahr, who is also lead author on the study’s Nov. 6 publication in JACC: Cardiovascular Interventions.

Observers of the study at TCT 2021 seemed enthusiastic about the study’s results but recognized that TMVR in its current form still has formidable limitations.

“This is clearly an exciting look into the future and very reassuring to a degree, aside from the complications, which are somewhat expected as we go with 30-plus French devices,” Rajiv Tayal, MD, MPH, said at a press conference on the Intrepid study held before Dr. Zahr’s formal presentation. Dr. Tayal is an interventional cardiologist with Valley Health System, Ridgewood, New Jersey, and New York Medical College, Valhalla.

“I think we’ve all learned that transapical [access] is just not a viable procedure for a lot of these patients, and so we’ve got to get to transfemoral,” Susheel K. Kodali, MD, interventional cardiologist at New York-Presbyterian/Columbia University Irving Medical Center, said at the same forum.

A 35 F device “is going to be too big,” he said. However, “it is the first step to iterate to a smaller device.” Dr. Kodali said his center contributed a patient to the study, and he is listed as a coauthor on the publication.

The delivery system’s large profile is only part of the vascular complication issue. Not only did the procedure require surgical cutdown for venous access, but “we were fairly aggressive in anticoagulating these patients with the fear of thrombus formation,” Dr. Zahr said in the discussion following his presentation.

“A postprocedure anticoagulation regimen is recommended within the protocol, but ultimate therapy was left to the discretion of the treating site physician,” the published report states, noting that all 14 patients with successful TMVR were discharged on warfarin. They included 12 who were also put on a single antiplatelet and one given dual antiplatelet therapy on top of the oral anticoagulant.

“One thing that we learned is that we probably should standardize our approach to perioperative anticoagulation,” Dr. Zahr observed. Also, a 29 F sheath for the system is in the works, “and we’re hoping that with smaller sheath size, and hopefully going even to percutaneous, might have an impact on lowering the vascular complications.”

Explanations for the “higher-than-expected vascular complication rate” remains somewhat unclear, agreed an editorial accompanying the study’s publication, “but may include a learning curve with the system, the large introducer sheath, the need for surgical cutdown, and postprocedural anticoagulation.”

For trans-septal TMVR to become a default approach, “venous access will need to be achieved percutaneously and vascular complications need to be infrequent,” contends the editorial, with lead author Mohamad Alkhouli, MD, Mayo Clinic, Rochester, Minn.

“These data provide a glimpse into the future of TMVR. The excellent short-term safety and effectiveness of this still very early-stage procedure represent a major step forward in the field,” they write.

A version of this article first appeared on Medscape.com.

It remains early days for transcatheter mitral-valve replacement (TMVR) as a minimally invasive way to treat severe, mitral regurgitation (MR), but it’s even earlier days for TMVR as an endovascular procedure. Most of the technique’s limited experience with a dedicated mitral prosthesis has involved transapical delivery.

But now a 15-patient study of transfemoral, transeptal TMVR – with a prosthesis designed for the mitral position and previously tested only transapically – has shown good 30-day results in that MR was essentially abolished with virtually no paravalvular leakage.

Nor were there adverse clinical events such as death, stroke, reintervention, or new need for a pacemaker in any of the high-surgical-risk patients with MR in this feasibility study of the transfemoral Intrepid TMVR System (Medtronic). Implantation failed, however, in one patient who then received a surgical valve via sternotomy.

The current cohort is part of a larger ongoing trial that will track whether patients implanted transfemorally with the Intrepid also show reverse remodeling and good clinical outcomes over at least a year. That study, called APOLLO, is one of several exploring dedicated TMVR valves from different companies, with names like SUMMIT, MISCEND, and TIARA-2.

Currently, TMVR is approved in the United States only using one device designed for the aortic position and only for treating failed surgical mitral bioprostheses in high-risk patients.

If the Intrepid transfemoral system has an Achilles’ heel, at least in the current iteration, it might be its 35 F catheter delivery system that requires surgical access to the femoral vein. Seven of the patients in the small series experienced major bleeding events, including six at the femoral access site, listed as major vascular complications.

Overall, the study’s patients “were extremely sick with a lot of comorbidity. A lot of them had atrial fibrillation, a lot of them were on anticoagulation to start with,” observed Firas Zahr, MD, Oregon Health & Science University, Portland, as part of his presentation of the study at Transcatheter Cardiovascular Therapeutics (TCT) 2021, held virtually as well as onsite in Orlando, Florida.

All had moderate-to-severe, usually primary MR; two thirds of the cohort had been in NYHA class III or IV at baseline, and 40% had been hospitalized for heart failure within the past year. Eight had a history of cardiovascular surgery, and eight had diabetes. Their mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 4.7, Dr. Zahr reported.

“At 30 days, there was a significant improvement in their heart failure classification; the vast majority of the patients were [NYHA] class I and class II,” said Dr. Zahr, who is also lead author on the study’s Nov. 6 publication in JACC: Cardiovascular Interventions.

Observers of the study at TCT 2021 seemed enthusiastic about the study’s results but recognized that TMVR in its current form still has formidable limitations.

“This is clearly an exciting look into the future and very reassuring to a degree, aside from the complications, which are somewhat expected as we go with 30-plus French devices,” Rajiv Tayal, MD, MPH, said at a press conference on the Intrepid study held before Dr. Zahr’s formal presentation. Dr. Tayal is an interventional cardiologist with Valley Health System, Ridgewood, New Jersey, and New York Medical College, Valhalla.

“I think we’ve all learned that transapical [access] is just not a viable procedure for a lot of these patients, and so we’ve got to get to transfemoral,” Susheel K. Kodali, MD, interventional cardiologist at New York-Presbyterian/Columbia University Irving Medical Center, said at the same forum.

A 35 F device “is going to be too big,” he said. However, “it is the first step to iterate to a smaller device.” Dr. Kodali said his center contributed a patient to the study, and he is listed as a coauthor on the publication.

The delivery system’s large profile is only part of the vascular complication issue. Not only did the procedure require surgical cutdown for venous access, but “we were fairly aggressive in anticoagulating these patients with the fear of thrombus formation,” Dr. Zahr said in the discussion following his presentation.

“A postprocedure anticoagulation regimen is recommended within the protocol, but ultimate therapy was left to the discretion of the treating site physician,” the published report states, noting that all 14 patients with successful TMVR were discharged on warfarin. They included 12 who were also put on a single antiplatelet and one given dual antiplatelet therapy on top of the oral anticoagulant.

“One thing that we learned is that we probably should standardize our approach to perioperative anticoagulation,” Dr. Zahr observed. Also, a 29 F sheath for the system is in the works, “and we’re hoping that with smaller sheath size, and hopefully going even to percutaneous, might have an impact on lowering the vascular complications.”

Explanations for the “higher-than-expected vascular complication rate” remains somewhat unclear, agreed an editorial accompanying the study’s publication, “but may include a learning curve with the system, the large introducer sheath, the need for surgical cutdown, and postprocedural anticoagulation.”

For trans-septal TMVR to become a default approach, “venous access will need to be achieved percutaneously and vascular complications need to be infrequent,” contends the editorial, with lead author Mohamad Alkhouli, MD, Mayo Clinic, Rochester, Minn.

“These data provide a glimpse into the future of TMVR. The excellent short-term safety and effectiveness of this still very early-stage procedure represent a major step forward in the field,” they write.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has long kept a watchful eye over successive iterations of endovascular stent graphs in the Endologix AFX line, designed for repair of abdominal aortic aneurysms (AAA). For years, the devices, first approved in 2011, have drawn safety alerts and recalls , stemming from what the agency says was a “higher than expected” risk for potentially injurious or fatal type III endoleaks.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has long kept a watchful eye over successive iterations of endovascular stent graphs in the Endologix AFX line, designed for repair of abdominal aortic aneurysms (AAA). For years, the devices, first approved in 2011, have drawn safety alerts and recalls , stemming from what the agency says was a “higher than expected” risk for potentially injurious or fatal type III endoleaks.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has long kept a watchful eye over successive iterations of endovascular stent graphs in the Endologix AFX line, designed for repair of abdominal aortic aneurysms (AAA). For years, the devices, first approved in 2011, have drawn safety alerts and recalls , stemming from what the agency says was a “higher than expected” risk for potentially injurious or fatal type III endoleaks.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

A version of this article first appeared on Medscape.com.

Up to one-third of patients with multiple sclerosis (MS) treated with the B-cell depleting monoclonal antibody ocrelizumab (Ocrevus) show some degree of repletion of B-cells toward the end of the 6-month infusion cycle. However, there are no corresponding worsening of symptoms or signs of a “wearing off” effect, new research shows.

“Most people expect that since this is a B-cell depleting drug, that if you are not depleting B cells, then that should be reflected clinically and there should be some breakthrough activity,” said study investigator Joshua D. Katz, MD, codirector of the Elliot Lewis Center for Multiple Sclerosis Care in Wellesley, Massachusetts.

Real-world study

Preapproval clinical trials of ocrelizumab suggest about 5% of patients experience a repletion of B cells. However, the timing and association with breakthrough symptoms were unclear.

To investigate, Dr. Katz and colleagues conducted two studies. The first is a substudy of the prospective ACAPELLA trial to assess ocrelizumab-associated adverse events in a real-world population. The study included 294 patients with relapsing and progressive forms of MS treated with at least two cycles of ocrelizumab, given as infusion once every 6 months.

The results showed that overall, 91 (31%) of the 294 patients had some degree of repletion at one or more timepoints.

In categorizing patients according to their highest CD19 measure after two cycles, 108 patients (64.7%) had no significant repletion of B-cells after infusion, defined as an increase of less than 10 cells/μL, while 45 (26.9%) were considered mild repleters, defined as having increases of 10-49 cells/μL.

Seven patients (4.2%) were moderate repleters, with an increase of 50-79 cells/μL, and 7 (4.2%) were categorized as marked repleters, with increases of 80 or more cells/μL.

Eight patients in the study fully repleted, with values from 114-319 cells/μL, occurring between 23 and 34 weeks of the last infusion.

However, there was no relationship between repletion of the B-cells and clinical or MRI evidence of relapse.

Of note, the proportion of patients who did not have B-cell repletion increased with greater numbers of infusions. Whereas 64.7% were non-repleters at cycle 2, that number increased to 88.8% by cycle 6, with a slight drop to 85.6% being non-repleters by cycle 7 (36 months).

“Mild B-cell repletion was fairly common after two cycles of ocrelizumab, but with repeated dosing, a greater proportion of patients were non-repleters, suggesting that cumulative exposure to ocrelizumab results in greater depletion,” the researchers noted.

However, “while the number of moderate or marked repleters in our study was small, they had a tendency to remain repleters over time with subsequent infusions,” they added.

In looking at patient characteristics, moderate and marketed repleters had higher mean BMI (34.1 and 32.6, respectively) compared with the non- and mild repleters (27.0 and 29.4, respectively; P < .0001).

Dr. Katz noted that the increased risk of B-cell repletion with higher BMI was not a surprise. This association, he said, “makes sense” because patients’ relative exposure to ocrelizumab decreases with higher BMI. Similar patterns with BMI were observed in the clinical trial for ocrelizumab approval, in which patients with lower BMI tended to have greater improvement.
 

No symptom worsening

In the second study, the investigators further examined changes in symptom burden related to the amount of time from ocrelizumab infusion. They evaluated 110 patients, aged 18-80 (mean age 44.8) who had Expanded Disability Status Scale (EDSS) scores between 0-7. Study participants were either initiating ocrelizumab or had been on the drug for at least 1 year.

Symptom burden was evaluated with the Neurological Disorders (Neuro-Qol) questionnaire and SymptoMScreen patient-reported outcomes at the beginning of the study at week 4, and near the end of the ocrelizumab infusion cycle, at week 22.

The researchers found that among 69 participants who completed the questionnaires, there were no significant differences at week 22 versus week 4 across a wide range of symptoms, including walking, spasticity, pain, fatigue, cognitive function, dizziness, and depression between the two timepoints.

The only change on the Neuro-QoL score was in the sleep disturbance domain, which improved marginally at the end of the cycle (P = .052). This study did not evaluate changes in B-cells.

Dr. Katz noted that the inclusion of patients over age of 55 in the study offered important insights.

“Our hypothesis was that we were going to start seeing a higher rate of complications, especially infections, in people who are older and may be at a higher risk of infection and disability,” Dr. Katz noted. “But so far, we haven’t seen any higher risk in older patients or those with more disability than anyone else, which is good news.”
 

Amplification of baseline symptoms not uncommon

Commenting on the research, Scott D. Newsome, DO, current president of the CMSC, noted that although no association was observed between the B-cell repletion and symptoms, amplification of flare-up symptoms that are linked to B-cell depleting therapy infusion timing are not uncommon.

“The ‘wearing-off’ phenomenon is not unique to the B-cell therapies,” said Dr. Newsome, who is also director of Johns Hopkins University’s Neurosciences Consultation and Infusion Center and an associate professor of neurology at the JHU med school. “With natalizumab (Tysabri), patients can have an amplification of baseline symptoms as they come closer to their next infusion, and it has been speculated that maybe it was something biologically happening, such as inflammatory cytokines ramping back up or some other mechanisms.”

“Now that we have the B-cell depleting therapies, we tend see the same kind of pattern, where a few weeks leading up to the next infusion, people will develop these amplified symptoms,” he said.

The possibility of a cumulative effect, appearing to address the B-cell repletion associated with early infusions, could have implications over time, Dr. Newsome noted.

“This is important because if people are going on these therapies long-term, the question we may need to ask is whether they actually need to continue to get an infusion every 6 months,” he said.

As these questions around the safety of long-term immunosuppressant drug use continue, different dosing regimens may need to be considered in order to mitigate potential infection risk, he added.

Dr. Katz reports consulting and/or speakers’ bureau relationships with Alexion, Biogen, EMD Serono, Genentech, Novartis, and Sanofi. Dr. Newsome reports relationships with Autobahn, BioIncept, Biogen, Genentech, Novartis, Bristol Myers Squibb, EMD Serono, Greenwich Biosciences, and MedDay Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Up to one-third of patients with multiple sclerosis (MS) treated with the B-cell depleting monoclonal antibody ocrelizumab (Ocrevus) show some degree of repletion of B-cells toward the end of the 6-month infusion cycle. However, there are no corresponding worsening of symptoms or signs of a “wearing off” effect, new research shows.

“Most people expect that since this is a B-cell depleting drug, that if you are not depleting B cells, then that should be reflected clinically and there should be some breakthrough activity,” said study investigator Joshua D. Katz, MD, codirector of the Elliot Lewis Center for Multiple Sclerosis Care in Wellesley, Massachusetts.

Real-world study

Preapproval clinical trials of ocrelizumab suggest about 5% of patients experience a repletion of B cells. However, the timing and association with breakthrough symptoms were unclear.

To investigate, Dr. Katz and colleagues conducted two studies. The first is a substudy of the prospective ACAPELLA trial to assess ocrelizumab-associated adverse events in a real-world population. The study included 294 patients with relapsing and progressive forms of MS treated with at least two cycles of ocrelizumab, given as infusion once every 6 months.

The results showed that overall, 91 (31%) of the 294 patients had some degree of repletion at one or more timepoints.

In categorizing patients according to their highest CD19 measure after two cycles, 108 patients (64.7%) had no significant repletion of B-cells after infusion, defined as an increase of less than 10 cells/μL, while 45 (26.9%) were considered mild repleters, defined as having increases of 10-49 cells/μL.

Seven patients (4.2%) were moderate repleters, with an increase of 50-79 cells/μL, and 7 (4.2%) were categorized as marked repleters, with increases of 80 or more cells/μL.

Eight patients in the study fully repleted, with values from 114-319 cells/μL, occurring between 23 and 34 weeks of the last infusion.

However, there was no relationship between repletion of the B-cells and clinical or MRI evidence of relapse.

Of note, the proportion of patients who did not have B-cell repletion increased with greater numbers of infusions. Whereas 64.7% were non-repleters at cycle 2, that number increased to 88.8% by cycle 6, with a slight drop to 85.6% being non-repleters by cycle 7 (36 months).

“Mild B-cell repletion was fairly common after two cycles of ocrelizumab, but with repeated dosing, a greater proportion of patients were non-repleters, suggesting that cumulative exposure to ocrelizumab results in greater depletion,” the researchers noted.

However, “while the number of moderate or marked repleters in our study was small, they had a tendency to remain repleters over time with subsequent infusions,” they added.

In looking at patient characteristics, moderate and marketed repleters had higher mean BMI (34.1 and 32.6, respectively) compared with the non- and mild repleters (27.0 and 29.4, respectively; P < .0001).

Dr. Katz noted that the increased risk of B-cell repletion with higher BMI was not a surprise. This association, he said, “makes sense” because patients’ relative exposure to ocrelizumab decreases with higher BMI. Similar patterns with BMI were observed in the clinical trial for ocrelizumab approval, in which patients with lower BMI tended to have greater improvement.
 

No symptom worsening

In the second study, the investigators further examined changes in symptom burden related to the amount of time from ocrelizumab infusion. They evaluated 110 patients, aged 18-80 (mean age 44.8) who had Expanded Disability Status Scale (EDSS) scores between 0-7. Study participants were either initiating ocrelizumab or had been on the drug for at least 1 year.

Symptom burden was evaluated with the Neurological Disorders (Neuro-Qol) questionnaire and SymptoMScreen patient-reported outcomes at the beginning of the study at week 4, and near the end of the ocrelizumab infusion cycle, at week 22.

The researchers found that among 69 participants who completed the questionnaires, there were no significant differences at week 22 versus week 4 across a wide range of symptoms, including walking, spasticity, pain, fatigue, cognitive function, dizziness, and depression between the two timepoints.

The only change on the Neuro-QoL score was in the sleep disturbance domain, which improved marginally at the end of the cycle (P = .052). This study did not evaluate changes in B-cells.

Dr. Katz noted that the inclusion of patients over age of 55 in the study offered important insights.

“Our hypothesis was that we were going to start seeing a higher rate of complications, especially infections, in people who are older and may be at a higher risk of infection and disability,” Dr. Katz noted. “But so far, we haven’t seen any higher risk in older patients or those with more disability than anyone else, which is good news.”
 

Amplification of baseline symptoms not uncommon

Commenting on the research, Scott D. Newsome, DO, current president of the CMSC, noted that although no association was observed between the B-cell repletion and symptoms, amplification of flare-up symptoms that are linked to B-cell depleting therapy infusion timing are not uncommon.

“The ‘wearing-off’ phenomenon is not unique to the B-cell therapies,” said Dr. Newsome, who is also director of Johns Hopkins University’s Neurosciences Consultation and Infusion Center and an associate professor of neurology at the JHU med school. “With natalizumab (Tysabri), patients can have an amplification of baseline symptoms as they come closer to their next infusion, and it has been speculated that maybe it was something biologically happening, such as inflammatory cytokines ramping back up or some other mechanisms.”

“Now that we have the B-cell depleting therapies, we tend see the same kind of pattern, where a few weeks leading up to the next infusion, people will develop these amplified symptoms,” he said.

The possibility of a cumulative effect, appearing to address the B-cell repletion associated with early infusions, could have implications over time, Dr. Newsome noted.

“This is important because if people are going on these therapies long-term, the question we may need to ask is whether they actually need to continue to get an infusion every 6 months,” he said.

As these questions around the safety of long-term immunosuppressant drug use continue, different dosing regimens may need to be considered in order to mitigate potential infection risk, he added.

Dr. Katz reports consulting and/or speakers’ bureau relationships with Alexion, Biogen, EMD Serono, Genentech, Novartis, and Sanofi. Dr. Newsome reports relationships with Autobahn, BioIncept, Biogen, Genentech, Novartis, Bristol Myers Squibb, EMD Serono, Greenwich Biosciences, and MedDay Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Up to one-third of patients with multiple sclerosis (MS) treated with the B-cell depleting monoclonal antibody ocrelizumab (Ocrevus) show some degree of repletion of B-cells toward the end of the 6-month infusion cycle. However, there are no corresponding worsening of symptoms or signs of a “wearing off” effect, new research shows.

“Most people expect that since this is a B-cell depleting drug, that if you are not depleting B cells, then that should be reflected clinically and there should be some breakthrough activity,” said study investigator Joshua D. Katz, MD, codirector of the Elliot Lewis Center for Multiple Sclerosis Care in Wellesley, Massachusetts.

Real-world study

Preapproval clinical trials of ocrelizumab suggest about 5% of patients experience a repletion of B cells. However, the timing and association with breakthrough symptoms were unclear.

To investigate, Dr. Katz and colleagues conducted two studies. The first is a substudy of the prospective ACAPELLA trial to assess ocrelizumab-associated adverse events in a real-world population. The study included 294 patients with relapsing and progressive forms of MS treated with at least two cycles of ocrelizumab, given as infusion once every 6 months.

The results showed that overall, 91 (31%) of the 294 patients had some degree of repletion at one or more timepoints.

In categorizing patients according to their highest CD19 measure after two cycles, 108 patients (64.7%) had no significant repletion of B-cells after infusion, defined as an increase of less than 10 cells/μL, while 45 (26.9%) were considered mild repleters, defined as having increases of 10-49 cells/μL.

Seven patients (4.2%) were moderate repleters, with an increase of 50-79 cells/μL, and 7 (4.2%) were categorized as marked repleters, with increases of 80 or more cells/μL.

Eight patients in the study fully repleted, with values from 114-319 cells/μL, occurring between 23 and 34 weeks of the last infusion.

However, there was no relationship between repletion of the B-cells and clinical or MRI evidence of relapse.

Of note, the proportion of patients who did not have B-cell repletion increased with greater numbers of infusions. Whereas 64.7% were non-repleters at cycle 2, that number increased to 88.8% by cycle 6, with a slight drop to 85.6% being non-repleters by cycle 7 (36 months).

“Mild B-cell repletion was fairly common after two cycles of ocrelizumab, but with repeated dosing, a greater proportion of patients were non-repleters, suggesting that cumulative exposure to ocrelizumab results in greater depletion,” the researchers noted.

However, “while the number of moderate or marked repleters in our study was small, they had a tendency to remain repleters over time with subsequent infusions,” they added.

In looking at patient characteristics, moderate and marketed repleters had higher mean BMI (34.1 and 32.6, respectively) compared with the non- and mild repleters (27.0 and 29.4, respectively; P < .0001).

Dr. Katz noted that the increased risk of B-cell repletion with higher BMI was not a surprise. This association, he said, “makes sense” because patients’ relative exposure to ocrelizumab decreases with higher BMI. Similar patterns with BMI were observed in the clinical trial for ocrelizumab approval, in which patients with lower BMI tended to have greater improvement.
 

No symptom worsening

In the second study, the investigators further examined changes in symptom burden related to the amount of time from ocrelizumab infusion. They evaluated 110 patients, aged 18-80 (mean age 44.8) who had Expanded Disability Status Scale (EDSS) scores between 0-7. Study participants were either initiating ocrelizumab or had been on the drug for at least 1 year.

Symptom burden was evaluated with the Neurological Disorders (Neuro-Qol) questionnaire and SymptoMScreen patient-reported outcomes at the beginning of the study at week 4, and near the end of the ocrelizumab infusion cycle, at week 22.

The researchers found that among 69 participants who completed the questionnaires, there were no significant differences at week 22 versus week 4 across a wide range of symptoms, including walking, spasticity, pain, fatigue, cognitive function, dizziness, and depression between the two timepoints.

The only change on the Neuro-QoL score was in the sleep disturbance domain, which improved marginally at the end of the cycle (P = .052). This study did not evaluate changes in B-cells.

Dr. Katz noted that the inclusion of patients over age of 55 in the study offered important insights.

“Our hypothesis was that we were going to start seeing a higher rate of complications, especially infections, in people who are older and may be at a higher risk of infection and disability,” Dr. Katz noted. “But so far, we haven’t seen any higher risk in older patients or those with more disability than anyone else, which is good news.”
 

Amplification of baseline symptoms not uncommon

Commenting on the research, Scott D. Newsome, DO, current president of the CMSC, noted that although no association was observed between the B-cell repletion and symptoms, amplification of flare-up symptoms that are linked to B-cell depleting therapy infusion timing are not uncommon.

“The ‘wearing-off’ phenomenon is not unique to the B-cell therapies,” said Dr. Newsome, who is also director of Johns Hopkins University’s Neurosciences Consultation and Infusion Center and an associate professor of neurology at the JHU med school. “With natalizumab (Tysabri), patients can have an amplification of baseline symptoms as they come closer to their next infusion, and it has been speculated that maybe it was something biologically happening, such as inflammatory cytokines ramping back up or some other mechanisms.”

“Now that we have the B-cell depleting therapies, we tend see the same kind of pattern, where a few weeks leading up to the next infusion, people will develop these amplified symptoms,” he said.

The possibility of a cumulative effect, appearing to address the B-cell repletion associated with early infusions, could have implications over time, Dr. Newsome noted.

“This is important because if people are going on these therapies long-term, the question we may need to ask is whether they actually need to continue to get an infusion every 6 months,” he said.

As these questions around the safety of long-term immunosuppressant drug use continue, different dosing regimens may need to be considered in order to mitigate potential infection risk, he added.

Dr. Katz reports consulting and/or speakers’ bureau relationships with Alexion, Biogen, EMD Serono, Genentech, Novartis, and Sanofi. Dr. Newsome reports relationships with Autobahn, BioIncept, Biogen, Genentech, Novartis, Bristol Myers Squibb, EMD Serono, Greenwich Biosciences, and MedDay Pharmaceuticals.

A version of this article first appeared on Medscape.com.

The death rate from Parkinson’s disease has increased by about 63% over the past 2 decades in the United States, according to what investigators say is the most comprehensive study in the nation of temporal trends in Parkinson’s disease mortality.

“The reason behind the rising death rates from Parkinson’s disease is not clear at present and warrants further investigation,” Wei Bao, MD, PhD, associate professor in the department of epidemiology at the University of Iowa College of Public Health, in Iowa City, said in an interview. “We know that people are living longer and the general population is getting older, but that doesn’t fully explain the increase we saw in the death rate in people with Parkinson’s disease,” Dr. Bao added in a statement.

“Understanding why more people are dying from this disease is critical if we are going to reverse the trend,” Dr. Bao said.

The study was published online Oct. 27 in Neurology.

Long-term data

The researchers used data from the National Vital Statistics System to determine national trends in Parkinson’s disease mortality overall and in several key subgroups. The analyses included 479,059 people who died of Parkinson’s disease between 1999 and 2019.

Over the 21-year period, the age-adjusted mortality from Parkinson’s disease rose from 5.4 per 100,000 in 1999 to 8.8 per 100,000 in 2019. The average annual percent change (APC) was 2.4% for the entire period.

During the study period, the number of deaths from Parkinson’s disease more than doubled, from 14,593 to 35,311.

The death rate from Parkinson’s disease increased significantly across all age groups. The average APC was 5.0% among adults younger than 65 years, 1.9% among those aged 65-74 years, 2.2% among those 75-84 years, and 2.7% among those 85 and older.

The death rate increased in both men and women, but age-adjusted Parkinson’s disease mortality was twice as high in men as in women. The researchers say one possible explanation for the sex difference is estrogen, which leads to higher dopamine levels in areas of the brain that control motor responses and may protect women from Parkinson’s disease.

The study also showed that White people are more likely to die from Parkinson’s disease than persons of other racial and ethnic groups. In 2019, the death rate per 100,000 was 9.7 for Whites, 6.5 for Hispanics, and 4.7 for non-Hispanic Blacks.

Previous studies have shown that compared with White people, Black and Hispanic people are less likely to see a neurologist, owing to socioeconomic barriers. This suggests that White people may be more likely to receive a Parkinson’s disease diagnosis, the researchers noted.

“It’s important to continue to evaluate long-term trends in Parkinson’s death rates,” Dr. Bao said.

“This can inform future research that may help pinpoint why more people are dying of the disease. Also, updating vital statistics about Parkinson’s death rates may be used for priority setting and financing of health care and policy,” Dr. Bao added.
 

1.2 million patients by 2030

Reached for comment, James Beck, PhD, chief scientific officer for the Parkinson’s Foundation, said these findings are not surprising. “They are aligned with the work the Parkinson’s Foundation has done to show that the number of people with Parkinson’s disease has increased over time. We are working on an improved estimate of Parkinson’s disease incidence and predict that Parkinson’s disease will continue to rise as the population ages, so an increase in mortality rates would be expected,” Dr. Beck said.

He noted that much of the public health statistics regarding Parkinson’s disease are outdated and that the Parkinson’s Foundation has been partnering with others to update them.

“For instance, to calculate an accurate estimate of the prevalence of Parkinson’s disease, the Parkinson’s Foundation Prevalence Project was formed. The findings from this group demonstrated that the number of people living with Parkinson’s disease will rise to nearly 1.2 million by 2030, a substantial increase from the estimate of 930,000 for 2020,” Dr. Beck said.

“The overarching message is that more people are being diagnosed with Parkinson’s disease, not that more people are dying from the disease,” he added.

“Over the last 20 years, our understanding of Parkinson’s disease has changed and developed, so clinicians are more aware and better able to properly diagnose Parkinson’s disease. This could mean that the cause is likely due to an increase in diagnosis rates and better recognition of Parkinson’s disease, which would lead to higher rates of identifying Parkinson’s disease as a cause of death,” said Dr. Beck.

The study had no targeted funding. Dr. Bao and Dr. Beck have indicated no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The death rate from Parkinson’s disease has increased by about 63% over the past 2 decades in the United States, according to what investigators say is the most comprehensive study in the nation of temporal trends in Parkinson’s disease mortality.

“The reason behind the rising death rates from Parkinson’s disease is not clear at present and warrants further investigation,” Wei Bao, MD, PhD, associate professor in the department of epidemiology at the University of Iowa College of Public Health, in Iowa City, said in an interview. “We know that people are living longer and the general population is getting older, but that doesn’t fully explain the increase we saw in the death rate in people with Parkinson’s disease,” Dr. Bao added in a statement.

“Understanding why more people are dying from this disease is critical if we are going to reverse the trend,” Dr. Bao said.

The study was published online Oct. 27 in Neurology.

Long-term data

The researchers used data from the National Vital Statistics System to determine national trends in Parkinson’s disease mortality overall and in several key subgroups. The analyses included 479,059 people who died of Parkinson’s disease between 1999 and 2019.

Over the 21-year period, the age-adjusted mortality from Parkinson’s disease rose from 5.4 per 100,000 in 1999 to 8.8 per 100,000 in 2019. The average annual percent change (APC) was 2.4% for the entire period.

During the study period, the number of deaths from Parkinson’s disease more than doubled, from 14,593 to 35,311.

The death rate from Parkinson’s disease increased significantly across all age groups. The average APC was 5.0% among adults younger than 65 years, 1.9% among those aged 65-74 years, 2.2% among those 75-84 years, and 2.7% among those 85 and older.

The death rate increased in both men and women, but age-adjusted Parkinson’s disease mortality was twice as high in men as in women. The researchers say one possible explanation for the sex difference is estrogen, which leads to higher dopamine levels in areas of the brain that control motor responses and may protect women from Parkinson’s disease.

The study also showed that White people are more likely to die from Parkinson’s disease than persons of other racial and ethnic groups. In 2019, the death rate per 100,000 was 9.7 for Whites, 6.5 for Hispanics, and 4.7 for non-Hispanic Blacks.

Previous studies have shown that compared with White people, Black and Hispanic people are less likely to see a neurologist, owing to socioeconomic barriers. This suggests that White people may be more likely to receive a Parkinson’s disease diagnosis, the researchers noted.

“It’s important to continue to evaluate long-term trends in Parkinson’s death rates,” Dr. Bao said.

“This can inform future research that may help pinpoint why more people are dying of the disease. Also, updating vital statistics about Parkinson’s death rates may be used for priority setting and financing of health care and policy,” Dr. Bao added.
 

1.2 million patients by 2030

Reached for comment, James Beck, PhD, chief scientific officer for the Parkinson’s Foundation, said these findings are not surprising. “They are aligned with the work the Parkinson’s Foundation has done to show that the number of people with Parkinson’s disease has increased over time. We are working on an improved estimate of Parkinson’s disease incidence and predict that Parkinson’s disease will continue to rise as the population ages, so an increase in mortality rates would be expected,” Dr. Beck said.

He noted that much of the public health statistics regarding Parkinson’s disease are outdated and that the Parkinson’s Foundation has been partnering with others to update them.

“For instance, to calculate an accurate estimate of the prevalence of Parkinson’s disease, the Parkinson’s Foundation Prevalence Project was formed. The findings from this group demonstrated that the number of people living with Parkinson’s disease will rise to nearly 1.2 million by 2030, a substantial increase from the estimate of 930,000 for 2020,” Dr. Beck said.

“The overarching message is that more people are being diagnosed with Parkinson’s disease, not that more people are dying from the disease,” he added.

“Over the last 20 years, our understanding of Parkinson’s disease has changed and developed, so clinicians are more aware and better able to properly diagnose Parkinson’s disease. This could mean that the cause is likely due to an increase in diagnosis rates and better recognition of Parkinson’s disease, which would lead to higher rates of identifying Parkinson’s disease as a cause of death,” said Dr. Beck.

The study had no targeted funding. Dr. Bao and Dr. Beck have indicated no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The death rate from Parkinson’s disease has increased by about 63% over the past 2 decades in the United States, according to what investigators say is the most comprehensive study in the nation of temporal trends in Parkinson’s disease mortality.

“The reason behind the rising death rates from Parkinson’s disease is not clear at present and warrants further investigation,” Wei Bao, MD, PhD, associate professor in the department of epidemiology at the University of Iowa College of Public Health, in Iowa City, said in an interview. “We know that people are living longer and the general population is getting older, but that doesn’t fully explain the increase we saw in the death rate in people with Parkinson’s disease,” Dr. Bao added in a statement.

“Understanding why more people are dying from this disease is critical if we are going to reverse the trend,” Dr. Bao said.

The study was published online Oct. 27 in Neurology.

Long-term data

The researchers used data from the National Vital Statistics System to determine national trends in Parkinson’s disease mortality overall and in several key subgroups. The analyses included 479,059 people who died of Parkinson’s disease between 1999 and 2019.

Over the 21-year period, the age-adjusted mortality from Parkinson’s disease rose from 5.4 per 100,000 in 1999 to 8.8 per 100,000 in 2019. The average annual percent change (APC) was 2.4% for the entire period.

During the study period, the number of deaths from Parkinson’s disease more than doubled, from 14,593 to 35,311.

The death rate from Parkinson’s disease increased significantly across all age groups. The average APC was 5.0% among adults younger than 65 years, 1.9% among those aged 65-74 years, 2.2% among those 75-84 years, and 2.7% among those 85 and older.

The death rate increased in both men and women, but age-adjusted Parkinson’s disease mortality was twice as high in men as in women. The researchers say one possible explanation for the sex difference is estrogen, which leads to higher dopamine levels in areas of the brain that control motor responses and may protect women from Parkinson’s disease.

The study also showed that White people are more likely to die from Parkinson’s disease than persons of other racial and ethnic groups. In 2019, the death rate per 100,000 was 9.7 for Whites, 6.5 for Hispanics, and 4.7 for non-Hispanic Blacks.

Previous studies have shown that compared with White people, Black and Hispanic people are less likely to see a neurologist, owing to socioeconomic barriers. This suggests that White people may be more likely to receive a Parkinson’s disease diagnosis, the researchers noted.

“It’s important to continue to evaluate long-term trends in Parkinson’s death rates,” Dr. Bao said.

“This can inform future research that may help pinpoint why more people are dying of the disease. Also, updating vital statistics about Parkinson’s death rates may be used for priority setting and financing of health care and policy,” Dr. Bao added.
 

1.2 million patients by 2030

Reached for comment, James Beck, PhD, chief scientific officer for the Parkinson’s Foundation, said these findings are not surprising. “They are aligned with the work the Parkinson’s Foundation has done to show that the number of people with Parkinson’s disease has increased over time. We are working on an improved estimate of Parkinson’s disease incidence and predict that Parkinson’s disease will continue to rise as the population ages, so an increase in mortality rates would be expected,” Dr. Beck said.

He noted that much of the public health statistics regarding Parkinson’s disease are outdated and that the Parkinson’s Foundation has been partnering with others to update them.

“For instance, to calculate an accurate estimate of the prevalence of Parkinson’s disease, the Parkinson’s Foundation Prevalence Project was formed. The findings from this group demonstrated that the number of people living with Parkinson’s disease will rise to nearly 1.2 million by 2030, a substantial increase from the estimate of 930,000 for 2020,” Dr. Beck said.

“The overarching message is that more people are being diagnosed with Parkinson’s disease, not that more people are dying from the disease,” he added.

“Over the last 20 years, our understanding of Parkinson’s disease has changed and developed, so clinicians are more aware and better able to properly diagnose Parkinson’s disease. This could mean that the cause is likely due to an increase in diagnosis rates and better recognition of Parkinson’s disease, which would lead to higher rates of identifying Parkinson’s disease as a cause of death,” said Dr. Beck.

The study had no targeted funding. Dr. Bao and Dr. Beck have indicated no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The path to more effective use of clinical pathways in oncology practice lies in greater collaboration between the various sectors – oncology practices, payors, employers, pathways’ vendors, pharmaceutical manufacturers and patients – said Winston Wong, PharmD, president of W-Squared Group in Longboat Key, Fla., and editor-in-chief of the Journal of Clinical Pathways.

Dr. Wong presented findings from the journal’s annual Oncology Clinical Pathways Benchmarking Survey at the Oncology Clinical Pathways Congress, which was held in October. As fee for service gives way to performance-based and risk-bearing reimbursements, he said, “we are observing renewed interest in pathways implementation among a more diverse group of [health care providers].”

More survey respondents said they expected to implement pathways within the next 2 years than in past surveys. “I think it’s partly because payors are starting to delegate more care decisions back to oncology practices, making them more accountable for the care they provide,” Dr. Wong said.

The 2021 survey included 871 respondents, most of them direct care providers based in community practices. At 94%, most said they believed clinical pathways increased quality of care, 87% said they improved clinical outcomes, and 84% said they controlled costs.

Also presented at the meeting were preliminary findings of the JCP 2021 Care Pathways Working Group, which identified barriers to wider clinical pathways use. These include a fragmented health care system, minimal interoperability between systems, lack of integration into practice work flows, lack of reduction in administrative burden and lack of understanding by payers of the impact of social determinants of health.

Oncology clinical pathways are protocols and drug regimens for cancer care. They are used by oncology practices, academic medical centers, health systems, payors, and third-party vendors to address efficacy, safety, tolerability, and cost, but physicians have raised concerns about the administrative burden of working with pathways or pathways that emphasize cost-cutting at the expense of treatment choices or the flexibility to respond to unique patient circumstances.

The American Society of Clinical Oncology responded to member concerns about pathways in a 2016 Policy Statement on Clinical Pathways in Oncology. The following year, ASCO issued Criteria for High-Quality Clinical Pathways, offering a mechanism for evaluating the quality of a pathway, which according to ASCO’s criteria should be expert driven, evidence based, patient focused, up to date, and comprehensive, with multiple stakeholder input.

“There’s uncertainty among providers as the health care system continues to evolve toward value-based care models,” said Stephen Grubbs, MD, ASCO’s vice president of care delivery. “There are a lot of challenges. Practices are at different points in their journey toward value-based care and how to reconcile their care delivery models with the alternate payment models.”

Robin T. Zon, MD, FACP, FASCO, a medical oncologist at Michiana Hematology Oncology in Mishawaka, Ind., and chair of ASCO’s Pathways Task Force, which has since disbanded, was asked if she thought integration of pathways into practice has improved in the 4 years since the task force completed its work. “We think so, but we don’t have the data to support that conclusion,” she replied. “We were concerned about how we could make life easier for clinicians having to deal with preauthorization and helping them with the administrative burdens. Our society is trying to point to the path forward.”
 

Social determinants come to the fore

Also widely discussed at the congress was the need for greater equity in health care and greater responsiveness to social determinants of health, Dr. Wong said. Disparities in care are common throughout chronic disease care, and social determinants are getting more attention with the growing emphasis on patient-centered care.

Patient preferences and circumstances come into play, for example, when the patient can’t afford a prescribed treatment, or if a recommended protocol of infusions for 4 or 5 days in a row conflicts with the patient’s need to keep working. “If you don’t have a caregiver readily able to take you to the doctor’s office, that impacts your choice of treatment,” Dr. Wong said. Other social factors include geography, life experience, tolerance for side effects, and racial or ethnic diversity.

“I think the personalized approach is growing – compared to 4 or 5 years ago, when social determinants and patient preferences weren’t really talked about,” he said. How payors incorporate these considerations varies widely, but larger practices are starting to talk to payors about taking on financial risk, and clinical pathways can help them control risk and cost. “It has to be a collaborative process with whomever you’re talking to. The movement will be successful to the degree we collaborate in a common direction.”
 

Complicated treatments

Ray Page, DO, PhD, FASCO, a medical oncologist and hematologist at the Center for Cancer and Blood Disorders in Fort Worth, Tex., said his group has used clinical pathways, offered by Elsevier and originally developed at the University of Pittsburgh Medical Center, since 2007. “It’s part of the culture of our practice, and a requirement to work here. Cancer medicine is becoming so complicated, no oncologist can humanly keep track of it all. You’ve got to have good tools,” he said.

“Part of the nuance of dealing with insurers is that we’ve tried to negotiate using our compliance with evidence-based clinical pathways.” Collaboration is the ultimate goal, Dr. Page said. “But that gets harder as health care becomes more corporatized and vertically integrated.”

Alan Balch, PhD, CEO of the National Patient Advocate Foundation in Washington, D.C., said that well-designed pathways offer a way to ensure that evidence-based cancer care is practiced, and that providers are presented with a short list of treatment options based on evidence-based guidelines like those from the National Comprehensive Cancer Network.

“But if you want to be consumer centric, reflecting the circumstances of the individual patient, you either have to make your pathway more sophisticated and nuanced in the choices it offers – or see it as just one tool in treatment decision-making, while allowing other, patient-centered processes by which the patient’s circumstances and preferences are considered.” Is there a name for that process? “It’s called shared decision-making,” Dr. Balch replied.

“I’m optimistic that oncology care is becoming more person centered, whether by pathways or other means,” he said. “How long that will take, and in what form, is another conversation. But there is greater awareness of the need.”

People are talking to each other more about pathways implementation, Dr. Zon added. Pathways uptake will probably never be 100%, and the large academic medical centers will continue to have their own ways of caring for the sickest of the sick outside of the pathways.

Dr. Zon wondered if there could be a more comprehensive or universal oncology pathway incorporating symptom control, triaging, preventive screening, supportive and palliative care, and the end of life, all of which have fairly standardized approaches. “At the congress, I proposed thinking about a different approach for the pathways model – one that is not only more patient centric, but incorporates social determinants of health and patient experience, reflecting different cultures and communities, combining these other approaches to be more comprehensive and supporting best approaches to cancer care while reducing total costs of care.”

The path to more effective use of clinical pathways in oncology practice lies in greater collaboration between the various sectors – oncology practices, payors, employers, pathways’ vendors, pharmaceutical manufacturers and patients – said Winston Wong, PharmD, president of W-Squared Group in Longboat Key, Fla., and editor-in-chief of the Journal of Clinical Pathways.

Dr. Wong presented findings from the journal’s annual Oncology Clinical Pathways Benchmarking Survey at the Oncology Clinical Pathways Congress, which was held in October. As fee for service gives way to performance-based and risk-bearing reimbursements, he said, “we are observing renewed interest in pathways implementation among a more diverse group of [health care providers].”

More survey respondents said they expected to implement pathways within the next 2 years than in past surveys. “I think it’s partly because payors are starting to delegate more care decisions back to oncology practices, making them more accountable for the care they provide,” Dr. Wong said.

The 2021 survey included 871 respondents, most of them direct care providers based in community practices. At 94%, most said they believed clinical pathways increased quality of care, 87% said they improved clinical outcomes, and 84% said they controlled costs.

Also presented at the meeting were preliminary findings of the JCP 2021 Care Pathways Working Group, which identified barriers to wider clinical pathways use. These include a fragmented health care system, minimal interoperability between systems, lack of integration into practice work flows, lack of reduction in administrative burden and lack of understanding by payers of the impact of social determinants of health.

Oncology clinical pathways are protocols and drug regimens for cancer care. They are used by oncology practices, academic medical centers, health systems, payors, and third-party vendors to address efficacy, safety, tolerability, and cost, but physicians have raised concerns about the administrative burden of working with pathways or pathways that emphasize cost-cutting at the expense of treatment choices or the flexibility to respond to unique patient circumstances.

The American Society of Clinical Oncology responded to member concerns about pathways in a 2016 Policy Statement on Clinical Pathways in Oncology. The following year, ASCO issued Criteria for High-Quality Clinical Pathways, offering a mechanism for evaluating the quality of a pathway, which according to ASCO’s criteria should be expert driven, evidence based, patient focused, up to date, and comprehensive, with multiple stakeholder input.

“There’s uncertainty among providers as the health care system continues to evolve toward value-based care models,” said Stephen Grubbs, MD, ASCO’s vice president of care delivery. “There are a lot of challenges. Practices are at different points in their journey toward value-based care and how to reconcile their care delivery models with the alternate payment models.”

Robin T. Zon, MD, FACP, FASCO, a medical oncologist at Michiana Hematology Oncology in Mishawaka, Ind., and chair of ASCO’s Pathways Task Force, which has since disbanded, was asked if she thought integration of pathways into practice has improved in the 4 years since the task force completed its work. “We think so, but we don’t have the data to support that conclusion,” she replied. “We were concerned about how we could make life easier for clinicians having to deal with preauthorization and helping them with the administrative burdens. Our society is trying to point to the path forward.”
 

Social determinants come to the fore

Also widely discussed at the congress was the need for greater equity in health care and greater responsiveness to social determinants of health, Dr. Wong said. Disparities in care are common throughout chronic disease care, and social determinants are getting more attention with the growing emphasis on patient-centered care.

Patient preferences and circumstances come into play, for example, when the patient can’t afford a prescribed treatment, or if a recommended protocol of infusions for 4 or 5 days in a row conflicts with the patient’s need to keep working. “If you don’t have a caregiver readily able to take you to the doctor’s office, that impacts your choice of treatment,” Dr. Wong said. Other social factors include geography, life experience, tolerance for side effects, and racial or ethnic diversity.

“I think the personalized approach is growing – compared to 4 or 5 years ago, when social determinants and patient preferences weren’t really talked about,” he said. How payors incorporate these considerations varies widely, but larger practices are starting to talk to payors about taking on financial risk, and clinical pathways can help them control risk and cost. “It has to be a collaborative process with whomever you’re talking to. The movement will be successful to the degree we collaborate in a common direction.”
 

Complicated treatments

Ray Page, DO, PhD, FASCO, a medical oncologist and hematologist at the Center for Cancer and Blood Disorders in Fort Worth, Tex., said his group has used clinical pathways, offered by Elsevier and originally developed at the University of Pittsburgh Medical Center, since 2007. “It’s part of the culture of our practice, and a requirement to work here. Cancer medicine is becoming so complicated, no oncologist can humanly keep track of it all. You’ve got to have good tools,” he said.

“Part of the nuance of dealing with insurers is that we’ve tried to negotiate using our compliance with evidence-based clinical pathways.” Collaboration is the ultimate goal, Dr. Page said. “But that gets harder as health care becomes more corporatized and vertically integrated.”

Alan Balch, PhD, CEO of the National Patient Advocate Foundation in Washington, D.C., said that well-designed pathways offer a way to ensure that evidence-based cancer care is practiced, and that providers are presented with a short list of treatment options based on evidence-based guidelines like those from the National Comprehensive Cancer Network.

“But if you want to be consumer centric, reflecting the circumstances of the individual patient, you either have to make your pathway more sophisticated and nuanced in the choices it offers – or see it as just one tool in treatment decision-making, while allowing other, patient-centered processes by which the patient’s circumstances and preferences are considered.” Is there a name for that process? “It’s called shared decision-making,” Dr. Balch replied.

“I’m optimistic that oncology care is becoming more person centered, whether by pathways or other means,” he said. “How long that will take, and in what form, is another conversation. But there is greater awareness of the need.”

People are talking to each other more about pathways implementation, Dr. Zon added. Pathways uptake will probably never be 100%, and the large academic medical centers will continue to have their own ways of caring for the sickest of the sick outside of the pathways.

Dr. Zon wondered if there could be a more comprehensive or universal oncology pathway incorporating symptom control, triaging, preventive screening, supportive and palliative care, and the end of life, all of which have fairly standardized approaches. “At the congress, I proposed thinking about a different approach for the pathways model – one that is not only more patient centric, but incorporates social determinants of health and patient experience, reflecting different cultures and communities, combining these other approaches to be more comprehensive and supporting best approaches to cancer care while reducing total costs of care.”

The path to more effective use of clinical pathways in oncology practice lies in greater collaboration between the various sectors – oncology practices, payors, employers, pathways’ vendors, pharmaceutical manufacturers and patients – said Winston Wong, PharmD, president of W-Squared Group in Longboat Key, Fla., and editor-in-chief of the Journal of Clinical Pathways.

Dr. Wong presented findings from the journal’s annual Oncology Clinical Pathways Benchmarking Survey at the Oncology Clinical Pathways Congress, which was held in October. As fee for service gives way to performance-based and risk-bearing reimbursements, he said, “we are observing renewed interest in pathways implementation among a more diverse group of [health care providers].”

More survey respondents said they expected to implement pathways within the next 2 years than in past surveys. “I think it’s partly because payors are starting to delegate more care decisions back to oncology practices, making them more accountable for the care they provide,” Dr. Wong said.

The 2021 survey included 871 respondents, most of them direct care providers based in community practices. At 94%, most said they believed clinical pathways increased quality of care, 87% said they improved clinical outcomes, and 84% said they controlled costs.

Also presented at the meeting were preliminary findings of the JCP 2021 Care Pathways Working Group, which identified barriers to wider clinical pathways use. These include a fragmented health care system, minimal interoperability between systems, lack of integration into practice work flows, lack of reduction in administrative burden and lack of understanding by payers of the impact of social determinants of health.

Oncology clinical pathways are protocols and drug regimens for cancer care. They are used by oncology practices, academic medical centers, health systems, payors, and third-party vendors to address efficacy, safety, tolerability, and cost, but physicians have raised concerns about the administrative burden of working with pathways or pathways that emphasize cost-cutting at the expense of treatment choices or the flexibility to respond to unique patient circumstances.

The American Society of Clinical Oncology responded to member concerns about pathways in a 2016 Policy Statement on Clinical Pathways in Oncology. The following year, ASCO issued Criteria for High-Quality Clinical Pathways, offering a mechanism for evaluating the quality of a pathway, which according to ASCO’s criteria should be expert driven, evidence based, patient focused, up to date, and comprehensive, with multiple stakeholder input.

“There’s uncertainty among providers as the health care system continues to evolve toward value-based care models,” said Stephen Grubbs, MD, ASCO’s vice president of care delivery. “There are a lot of challenges. Practices are at different points in their journey toward value-based care and how to reconcile their care delivery models with the alternate payment models.”

Robin T. Zon, MD, FACP, FASCO, a medical oncologist at Michiana Hematology Oncology in Mishawaka, Ind., and chair of ASCO’s Pathways Task Force, which has since disbanded, was asked if she thought integration of pathways into practice has improved in the 4 years since the task force completed its work. “We think so, but we don’t have the data to support that conclusion,” she replied. “We were concerned about how we could make life easier for clinicians having to deal with preauthorization and helping them with the administrative burdens. Our society is trying to point to the path forward.”
 

Social determinants come to the fore

Also widely discussed at the congress was the need for greater equity in health care and greater responsiveness to social determinants of health, Dr. Wong said. Disparities in care are common throughout chronic disease care, and social determinants are getting more attention with the growing emphasis on patient-centered care.

Patient preferences and circumstances come into play, for example, when the patient can’t afford a prescribed treatment, or if a recommended protocol of infusions for 4 or 5 days in a row conflicts with the patient’s need to keep working. “If you don’t have a caregiver readily able to take you to the doctor’s office, that impacts your choice of treatment,” Dr. Wong said. Other social factors include geography, life experience, tolerance for side effects, and racial or ethnic diversity.

“I think the personalized approach is growing – compared to 4 or 5 years ago, when social determinants and patient preferences weren’t really talked about,” he said. How payors incorporate these considerations varies widely, but larger practices are starting to talk to payors about taking on financial risk, and clinical pathways can help them control risk and cost. “It has to be a collaborative process with whomever you’re talking to. The movement will be successful to the degree we collaborate in a common direction.”
 

Complicated treatments

Ray Page, DO, PhD, FASCO, a medical oncologist and hematologist at the Center for Cancer and Blood Disorders in Fort Worth, Tex., said his group has used clinical pathways, offered by Elsevier and originally developed at the University of Pittsburgh Medical Center, since 2007. “It’s part of the culture of our practice, and a requirement to work here. Cancer medicine is becoming so complicated, no oncologist can humanly keep track of it all. You’ve got to have good tools,” he said.

“Part of the nuance of dealing with insurers is that we’ve tried to negotiate using our compliance with evidence-based clinical pathways.” Collaboration is the ultimate goal, Dr. Page said. “But that gets harder as health care becomes more corporatized and vertically integrated.”

Alan Balch, PhD, CEO of the National Patient Advocate Foundation in Washington, D.C., said that well-designed pathways offer a way to ensure that evidence-based cancer care is practiced, and that providers are presented with a short list of treatment options based on evidence-based guidelines like those from the National Comprehensive Cancer Network.

“But if you want to be consumer centric, reflecting the circumstances of the individual patient, you either have to make your pathway more sophisticated and nuanced in the choices it offers – or see it as just one tool in treatment decision-making, while allowing other, patient-centered processes by which the patient’s circumstances and preferences are considered.” Is there a name for that process? “It’s called shared decision-making,” Dr. Balch replied.

“I’m optimistic that oncology care is becoming more person centered, whether by pathways or other means,” he said. “How long that will take, and in what form, is another conversation. But there is greater awareness of the need.”

People are talking to each other more about pathways implementation, Dr. Zon added. Pathways uptake will probably never be 100%, and the large academic medical centers will continue to have their own ways of caring for the sickest of the sick outside of the pathways.

Dr. Zon wondered if there could be a more comprehensive or universal oncology pathway incorporating symptom control, triaging, preventive screening, supportive and palliative care, and the end of life, all of which have fairly standardized approaches. “At the congress, I proposed thinking about a different approach for the pathways model – one that is not only more patient centric, but incorporates social determinants of health and patient experience, reflecting different cultures and communities, combining these other approaches to be more comprehensive and supporting best approaches to cancer care while reducing total costs of care.”

LAS VEGAS – An automated cleaning system outperformed manual cleaning of duodenoscopes in a comparative study. The results included measurements of residual proteins and carbohydrates in all duodenoscope working channels and elevators.

The new automated cleaning system, called the MACH 1, can be added to existing reprocessing areas and is about the size of a commercial washing machine. Cleaning alone takes about 30 minutes, and clean plus high-level disinfection (HLD) takes about an hour, according to Michael O’Donnell, MD, who is a gastroenterology fellow at NYU Langone Health. “Data from prior studies of other automated endoscope reprocessors indicate that MACH 1 more consistently delivers cleaning results that meet or exceed Food and Drug Administration/AAMI (Association for the Advancement of Medical Instrumentation) guidelines,” Dr. O’Donnell said in an interview. He presented the study at the annual meeting of the American College of Gastroenterology.

Outbreaks of multidrug resistant organism (MDRO) transmission have been linked to inadequately cleaned duodenoscopes, which has led to greater attention being paid to duodenoscope reprocessing, including prewash, manual cleaning, and disinfection or sterilization, according to Dr. O’Donnell. Postmarketing surveillance by duodenoscope manufacturers Fujifilm, Olympus, and Pentax found a contamination rate of 5.4% for any high-concern organisms – far higher than the initially assumed 0.4%.

The researchers used FDA standard maximum allowed contaminant threshold of < 6.4 mcg/cm² protein and < 2.2 mcg/cm² carbohydrate. Sampling sites on the duodenoscopes included the elevator wire channel port when present, the biopsy port, the elevator wire channel, the instrument channel, and the elevator recess.

The study included Olympic TJF-Q180V duodenoscopes used in 48 endoscopic retrograde cholangiopancreatography (ERCP) procedures. Each instrument went through standard bedside precleaning; 21 were then cleaned manually by trained technicians following manufacturing instructions, and 27 were cleaned using the automated cleaning system.

In the manually cleaned duodenoscopes, the average level of residual protein was 4.88 mcg/cm², versus 0.16 mcg/cm² in the automated clean group. The average carbohydrate residues were 1.09 mcg/cm² and 0.14 mcg/cm², respectively. In all, 2 of the 21 manually cleaned devices had protein levels higher than the FDA threshold, versus none in the automated clean group. In addition, 3 of 21 in the manually cleaned group had higher than threshold carbohydrate levels, versus none in the automated clean group. Overall, 4 of the 27 manually cleaned devices and none of the 21 automated clean devices had protein or carbohydrate levels above FDA thresholds.
 

Removing variability from cleaning

The cleaning step is critical because failure to remove bioburden can reduce the efficacy of later HLD or sterilization. Cleaning is typically done manually, but the physical complexity of the duodenoscope makes it challenging to do it thoroughly. Manual cleaning is also susceptible to human error or insufficient training, and an observational study found that at least one error occurred in more than 90% of observed cleaning operations.

The MACH 1 uses turbulent flow and resultant shearing forces to clean the duodenoscope. The device is currently used at the medical device company Parametrik as part of a program that delivers clean duodenoscopes and ultrasound scopes to its customers. The service is currently available only in the New York metro area, but the company intends to expand to other cities in 2022. The company also has plans to sell the MACH 1 in the near future at prices comparable to automated endoscope reprocessors that don’t clean, according to Dr. O’Donnell.

“This is a huge issue, not only practically for patient care, but it’s very much in the public eye. As people who do ERCP, this is a question that patients will come to us with, so we want to be as diligent as possible to drive the bioburden in the scope as low as we can. At least intuitively, that makes sense,” said Patrick Young, MD, who comoderated the session and is a professor of medicine at the Uniformed Services University, Bethesda, Md.

He noted that the system has an advantage in that it can be applied to duodenoscopes already in house. Other approaches to the issue of improperly cleaned duodenoscopes include scopes that can be returned to the manufacturer for cleaning, or removable end cap to facilitate access to difficult to clean parts. And then there are disposal duodenoscopes. “If you’re throwing a scope away every time you use it, you worry about landfill issues and some of the long term effects of that,” said Dr. Young.

Perhaps the most important attribute of the automated cleaning device is that it allows the user to eliminate variation in the cleaning procedure. High-reliability organizations aspire to eliminating variability. “This will probably make it easier to be consistent across technicians – for example, maybe there’s one tech that cleans great and one tech that doesn’t. This may take some of that out of the equation and give you a more thorough cleaning regardless of circumstance or personnel working on it. So I think it’s exciting to have another option that might be less costly than buying new scopes,” said Dr. Young.

Dr. O’Donnell and Dr. Young have no relevant financial disclosures.

LAS VEGAS – An automated cleaning system outperformed manual cleaning of duodenoscopes in a comparative study. The results included measurements of residual proteins and carbohydrates in all duodenoscope working channels and elevators.

The new automated cleaning system, called the MACH 1, can be added to existing reprocessing areas and is about the size of a commercial washing machine. Cleaning alone takes about 30 minutes, and clean plus high-level disinfection (HLD) takes about an hour, according to Michael O’Donnell, MD, who is a gastroenterology fellow at NYU Langone Health. “Data from prior studies of other automated endoscope reprocessors indicate that MACH 1 more consistently delivers cleaning results that meet or exceed Food and Drug Administration/AAMI (Association for the Advancement of Medical Instrumentation) guidelines,” Dr. O’Donnell said in an interview. He presented the study at the annual meeting of the American College of Gastroenterology.

Outbreaks of multidrug resistant organism (MDRO) transmission have been linked to inadequately cleaned duodenoscopes, which has led to greater attention being paid to duodenoscope reprocessing, including prewash, manual cleaning, and disinfection or sterilization, according to Dr. O’Donnell. Postmarketing surveillance by duodenoscope manufacturers Fujifilm, Olympus, and Pentax found a contamination rate of 5.4% for any high-concern organisms – far higher than the initially assumed 0.4%.

The researchers used FDA standard maximum allowed contaminant threshold of < 6.4 mcg/cm² protein and < 2.2 mcg/cm² carbohydrate. Sampling sites on the duodenoscopes included the elevator wire channel port when present, the biopsy port, the elevator wire channel, the instrument channel, and the elevator recess.

The study included Olympic TJF-Q180V duodenoscopes used in 48 endoscopic retrograde cholangiopancreatography (ERCP) procedures. Each instrument went through standard bedside precleaning; 21 were then cleaned manually by trained technicians following manufacturing instructions, and 27 were cleaned using the automated cleaning system.

In the manually cleaned duodenoscopes, the average level of residual protein was 4.88 mcg/cm², versus 0.16 mcg/cm² in the automated clean group. The average carbohydrate residues were 1.09 mcg/cm² and 0.14 mcg/cm², respectively. In all, 2 of the 21 manually cleaned devices had protein levels higher than the FDA threshold, versus none in the automated clean group. In addition, 3 of 21 in the manually cleaned group had higher than threshold carbohydrate levels, versus none in the automated clean group. Overall, 4 of the 27 manually cleaned devices and none of the 21 automated clean devices had protein or carbohydrate levels above FDA thresholds.
 

Removing variability from cleaning

The cleaning step is critical because failure to remove bioburden can reduce the efficacy of later HLD or sterilization. Cleaning is typically done manually, but the physical complexity of the duodenoscope makes it challenging to do it thoroughly. Manual cleaning is also susceptible to human error or insufficient training, and an observational study found that at least one error occurred in more than 90% of observed cleaning operations.

The MACH 1 uses turbulent flow and resultant shearing forces to clean the duodenoscope. The device is currently used at the medical device company Parametrik as part of a program that delivers clean duodenoscopes and ultrasound scopes to its customers. The service is currently available only in the New York metro area, but the company intends to expand to other cities in 2022. The company also has plans to sell the MACH 1 in the near future at prices comparable to automated endoscope reprocessors that don’t clean, according to Dr. O’Donnell.

“This is a huge issue, not only practically for patient care, but it’s very much in the public eye. As people who do ERCP, this is a question that patients will come to us with, so we want to be as diligent as possible to drive the bioburden in the scope as low as we can. At least intuitively, that makes sense,” said Patrick Young, MD, who comoderated the session and is a professor of medicine at the Uniformed Services University, Bethesda, Md.

He noted that the system has an advantage in that it can be applied to duodenoscopes already in house. Other approaches to the issue of improperly cleaned duodenoscopes include scopes that can be returned to the manufacturer for cleaning, or removable end cap to facilitate access to difficult to clean parts. And then there are disposal duodenoscopes. “If you’re throwing a scope away every time you use it, you worry about landfill issues and some of the long term effects of that,” said Dr. Young.

Perhaps the most important attribute of the automated cleaning device is that it allows the user to eliminate variation in the cleaning procedure. High-reliability organizations aspire to eliminating variability. “This will probably make it easier to be consistent across technicians – for example, maybe there’s one tech that cleans great and one tech that doesn’t. This may take some of that out of the equation and give you a more thorough cleaning regardless of circumstance or personnel working on it. So I think it’s exciting to have another option that might be less costly than buying new scopes,” said Dr. Young.

Dr. O’Donnell and Dr. Young have no relevant financial disclosures.

LAS VEGAS – An automated cleaning system outperformed manual cleaning of duodenoscopes in a comparative study. The results included measurements of residual proteins and carbohydrates in all duodenoscope working channels and elevators.

The new automated cleaning system, called the MACH 1, can be added to existing reprocessing areas and is about the size of a commercial washing machine. Cleaning alone takes about 30 minutes, and clean plus high-level disinfection (HLD) takes about an hour, according to Michael O’Donnell, MD, who is a gastroenterology fellow at NYU Langone Health. “Data from prior studies of other automated endoscope reprocessors indicate that MACH 1 more consistently delivers cleaning results that meet or exceed Food and Drug Administration/AAMI (Association for the Advancement of Medical Instrumentation) guidelines,” Dr. O’Donnell said in an interview. He presented the study at the annual meeting of the American College of Gastroenterology.

Outbreaks of multidrug resistant organism (MDRO) transmission have been linked to inadequately cleaned duodenoscopes, which has led to greater attention being paid to duodenoscope reprocessing, including prewash, manual cleaning, and disinfection or sterilization, according to Dr. O’Donnell. Postmarketing surveillance by duodenoscope manufacturers Fujifilm, Olympus, and Pentax found a contamination rate of 5.4% for any high-concern organisms – far higher than the initially assumed 0.4%.

The researchers used FDA standard maximum allowed contaminant threshold of < 6.4 mcg/cm² protein and < 2.2 mcg/cm² carbohydrate. Sampling sites on the duodenoscopes included the elevator wire channel port when present, the biopsy port, the elevator wire channel, the instrument channel, and the elevator recess.

The study included Olympic TJF-Q180V duodenoscopes used in 48 endoscopic retrograde cholangiopancreatography (ERCP) procedures. Each instrument went through standard bedside precleaning; 21 were then cleaned manually by trained technicians following manufacturing instructions, and 27 were cleaned using the automated cleaning system.

In the manually cleaned duodenoscopes, the average level of residual protein was 4.88 mcg/cm², versus 0.16 mcg/cm² in the automated clean group. The average carbohydrate residues were 1.09 mcg/cm² and 0.14 mcg/cm², respectively. In all, 2 of the 21 manually cleaned devices had protein levels higher than the FDA threshold, versus none in the automated clean group. In addition, 3 of 21 in the manually cleaned group had higher than threshold carbohydrate levels, versus none in the automated clean group. Overall, 4 of the 27 manually cleaned devices and none of the 21 automated clean devices had protein or carbohydrate levels above FDA thresholds.
 

Removing variability from cleaning

The cleaning step is critical because failure to remove bioburden can reduce the efficacy of later HLD or sterilization. Cleaning is typically done manually, but the physical complexity of the duodenoscope makes it challenging to do it thoroughly. Manual cleaning is also susceptible to human error or insufficient training, and an observational study found that at least one error occurred in more than 90% of observed cleaning operations.

The MACH 1 uses turbulent flow and resultant shearing forces to clean the duodenoscope. The device is currently used at the medical device company Parametrik as part of a program that delivers clean duodenoscopes and ultrasound scopes to its customers. The service is currently available only in the New York metro area, but the company intends to expand to other cities in 2022. The company also has plans to sell the MACH 1 in the near future at prices comparable to automated endoscope reprocessors that don’t clean, according to Dr. O’Donnell.

“This is a huge issue, not only practically for patient care, but it’s very much in the public eye. As people who do ERCP, this is a question that patients will come to us with, so we want to be as diligent as possible to drive the bioburden in the scope as low as we can. At least intuitively, that makes sense,” said Patrick Young, MD, who comoderated the session and is a professor of medicine at the Uniformed Services University, Bethesda, Md.

He noted that the system has an advantage in that it can be applied to duodenoscopes already in house. Other approaches to the issue of improperly cleaned duodenoscopes include scopes that can be returned to the manufacturer for cleaning, or removable end cap to facilitate access to difficult to clean parts. And then there are disposal duodenoscopes. “If you’re throwing a scope away every time you use it, you worry about landfill issues and some of the long term effects of that,” said Dr. Young.

Perhaps the most important attribute of the automated cleaning device is that it allows the user to eliminate variation in the cleaning procedure. High-reliability organizations aspire to eliminating variability. “This will probably make it easier to be consistent across technicians – for example, maybe there’s one tech that cleans great and one tech that doesn’t. This may take some of that out of the equation and give you a more thorough cleaning regardless of circumstance or personnel working on it. So I think it’s exciting to have another option that might be less costly than buying new scopes,” said Dr. Young.

Dr. O’Donnell and Dr. Young have no relevant financial disclosures.

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Editor’s note: Hospitalists told us about process changes that their teams have implemented during the COVID-19 pandemic.

Shyam Odeti, MD, SFHM

Ballad Health (Bristol, Tenn.)(Dr. Odeti was a hospitalist at Ballad Health during the period he describes below. He is currently chief of hospital medicine at Carilion Clinic, Roanoke, Va.)

Ballad Health is a 21-hospital health system serving 1.2 million population in 21 counties of rural Appalachia (northeast Tennessee, southwest Virginia, western North Carolina, and Kentucky). We saw a significant spike in COVID-19 numbers beginning in October 2020. We were at a 7.9% test positivity rate and 89 COVID-19 hospitalizations on Oct. 1, which rapidly increased to over 18% positivity rate and over 250 hospitalizations by mid-November. This alarming trend created concerns about handling the future inpatient volumes in an already strained health system.

There were some unique challenges to this region that were contributing to the increased hospitalizations. A significant part of the population we serve in this region has low health literacy, low socioeconomic status, and problems with transportation. Telehealth in an outpatient setting was rudimentary in parts of this region.

Ballad Health developed Safe At Home to identify lower-acuity COVID-19 patients and transition them to the home setting safely. This in turn would prevent their readmissions or return visits to the ED by implementing comprehensive oversight to their disease course. We achieved this through a collaborative approach of the existing teams, case management, telenurse team, primary care providers, and hospitalist-led transitional care. We leveraged the newly implemented EHR Epic and telehealth under the leadership of Ballad Health’s chief medical information officer, Dr. Mark Wilkinson.

Among the patients diagnosed with COVID-19 in ED and urgent care, low acuity cases were identified and enrolled into Safe At Home. Patients were provided with a pulse oximeter, thermometer, and incentive spirometer. They received phone calls the next 2 days from the telenurse team for a comprehensive interview, followed by daily phone calls during the first week. If no concerns were raised initially, then calls were spaced to every 3 days after that for up to 2 weeks. Any complaints or alarming symptoms would trigger a telehealth visit with primary care physicians, transitional care clinics, or a hospitalist.

The Safe At Home program was highly successful – in the past 5 months, over 1,500 patients were enrolled and hundreds of admissions were likely avoided. As we feared, the positivity rate in our region went close to 35% and inpatient COVID-19 census was over 350, with ICU utilization over 92%. If not for our innovative solution, this pandemic could have easily paralyzed health care in our region. Our patients also felt safe, as they were monitored daily and had help one call away, 24/7.

This innovation has brought solutions through technological advancements and process improvement. Safe At Home was also instrumental in breaking down silos and developing a culture of collaboration and cohesiveness among the inpatient, outpatient, and virtual teams of the health system. Lessons learned from this initiative can be easily replicated in the management of several chronic diseases to provide safe and affordable care to our patients in the comfort of their homes.
 

Vasundara Singh, MBBS

Mount Sinai West (New York)

At the onset of the pandemic in New York, our medium-sized midtown hospital used personal protective equipment briskly. One reason identified was the failure to cohort COVID-19 patients on a single floor. The other more important cause was that medicine teams in our hospital have patients scattered throughout the hospital in a nongeographic model across four different floors. Within 2 weeks, administration and hospital medicine leadership developed a geographic model. We started cohorting all COVID-19 positive patients on separate floors from negative patients. A geographic physician team model was also developed, which allowed physicians and nurses to don and doff at the entry and exit of each COVID-19 unit.

After the pandemic surge, hospital medicine and internal medicine residency program leadership made the collective decision to continue the geographic model for inpatient care. Care providers enjoyed working in a unit-based model, and noted increases in efficiency while rounding. Each of our four medicine floors has 36-40 beds, with variable occupancy. We restructured our resident teams and physician assistant teams by geography. Our outgoing chief residents led the change in May, designing a resident schedule to accommodate for a resident on each team to be available to admit and provide coverage until 8 p.m. each evening on their respective floors. The hospital medicine leadership put together a committee comprising representation of all stakeholders in this large transition of systems: attending hospitalists, physician assistants, chief residents, nurse managers, bed assignment, and administration. Since the transition and resumption of normal inpatient activity, we have encountered and addressed multiple concerns. Some notable hurdles in this transition included the high throughput on our telemetry team, movement of patients by bed board or nursing without involving the physicians in the decision, and variable nursing staffing that impacts teaching team caps because of geographic model.

This transition is very much still a work in progress, yet some benefits are already obvious. It has made bedside rounding more appealing and uncomplicated. Physicians in training learn very well at the bedside by role modeling. Greater acceptance of bedside rounding also affords the opportunity to teach physical exam skills, a dying art amongst newer generations of doctors. Another large gain is being able to involve nursing in bedside rounds, discussions, and decision-making. Finally, coordination with ancillary staff including social work and case management has become seamless as a result of having an entire floor to ourselves.

In summary, the silver lining of this pernicious pandemic at our hospital has been a transition to a geographic model for inpatient care. This is considered to be the gold standard for inpatient care across multiple health systems, and we hope to continue to refine this geographic model of care. Next steps would involve developing capabilities with flex acuity beds on each unit so that no matter what the patients need they can stay in one place.
 

Marina Farah, MD, MHA

Sound Physicians (Tacoma, Wash.)

With hospital programs in over 40 states, Sound Physicians has played an important role in the COVID-19 pandemic, treating approximately 6% of all COVID hospitalizations nationwide. To meet the needs of the crisis, Sound relied on innovation to expand coverage and improve outcomes at facilities across the country. Of one particular note, Sound Telemedicine partnered with the University of Maryland Medical System to open the state’s first COVID-only hospital. In March 2020, the UMMS needed to care for an emerging cohort of COVID-19 patients while maintaining high-quality care and minimizing exposure for non-COVID patients.

Sound collaborated with UMMS to rapidly reopen the University of Maryland Laurel Medical Center for COVID-only care, staffing the hospital with Sound’s telehospitalists. A model based on daily rounding delivered 100% by telemedicine providers and flexible staffing available 24/7 would let the program scale up or down to meet volume demands. Onsite physician support would be limited to one admitting doctor and a nocturnist. The COVID-only facility allowed a small group of doctors, nurses, and technicians to focus exclusively on an emerging disease, honing critical skills for treating COVID-19 patients.

Immediate benefits yielded big results. UMLMC’s capacity allowed UMMS to funnel COVID patients into fewer of their regional hospitals, limiting the risk of exposure. Rapid deployment got UMMS ahead of the surge, taking stress off other hospitals in the system and 24/7 telehospitalist coverage proved to be a successful long-term staffing strategy for UMLMC. Long-term benefits were recognized too. Sound’s staffing model and clinical processes significantly improved quality of care. Mortality rates dropped from 18% to 9% during the initial 60 days of the program. Vaccinations shifted COVID-19 needs, however, due to improvements in care and the flexibility offered, telemedicine remains an integral part of the UMMS’s long-term strategy
 

Emory Healthcare division of hospital medicine (Atlanta)

(Comments compiled by James Kim, MD, assistant professor in the division of hospital medicine) Ingrid Pinzon, MD, FACP Emory Johns Creek (Ga.) Hospital

When COVID-19 started, one of the things called to my attention was the disparity in education for the Hispanic population. Unfortunately, COVID showed how in our hospitals there is a lack of instructions and education in Spanish.

We started educating our Hispanic community with Facebook lives via the Latin American Association. I was also invited to the different Spanish news stations (Telemundo and Univision). I also educated this community through food drives, where I taught about the use of face masks, social distancing, and hand hygiene.

Reena Hemrajani, MD

Grady Memorial Hospital

At Grady, we transitioned our weekly educational conferences into virtual events, and this has increased our attendance, as more off-service people are likely to attend when they can log on remotely. This has also allowed us to record these sessions for later viewing by those were unable to make it in real time.

Yelena Burklin, MD, FHM

Emory University Hospital Midtown

In our Midtown group, we have started a few initiatives that we will continue post COVID. Hybrid didactic lectures have had great success with excellent attendance when our didactic sessions (lunch and learns, journal clubs, core lectures for step-down unit refresher series) have been conducted virtually.

During the pandemic’s height, when all resources were dedicated to COVID-19 patient care, there was a particular need to cognitively separate from “all things COVID” and provide additional topics to learn about, such as review of the management of different types of shock, chronic obstructive pulmonary disorder, sepsis, liver cirrhosis, etc. Attendance to these non–COVID-19 sessions was just as high.

We had a number of stressful and near-death experiences that tested our resilience, professional integrity, and overall wellness. These reflections prompted us to invite psychiatrists to one of the in-person–only sessions so that an informal conversation could be afforded in a safe space. Those hospitalists who felt the need to discuss their issues further received additional support and instructions from a subspecialist.

Ray Dantes, MD

Emory University Hospital Midtown

Post COVID, we will certainly utilize a hybrid approach to the didactic sessions when patient sensitive information is not being discussed. We will also preserve the continuity in addressing wellness and resilience, particularly, when our Midtown hospitalists had to work a lot of extra hours to cover the growing need at the time of pandemic, and need to emotionally decompress post pandemic. We are also taking infection control more seriously, and not coming to work with upper respiratory infections.

Rajasree Roy, MD

Emory Saint Joseph’s Hospital

At ESJH, we initiated a telemedicine pilot for our hospitalist team in order to sustain our service given census surge and physician illness.

Sara Millwee, DNP, APRN, FNP-BC

Emory chief of advanced practice providers

To help reduce exposure to COVID, our advanced practice providers (APPs) admitted patients from the ED (as they did pre-COVID) to the hospital medicine service, but the physicians administratively signed the note/orders. Emory Healthcare bylaws specify that patients are seen by a physician within 24 hours of admission. During the pandemic, at the time of admission, the APP discussed plan of care with the physician, but the patient was only seen by the APP upon initial evaluation/admission, as opposed to the physician and APP pre-COVID. This improved productivity, and facilitated communication and collaboration between APPs and physicians. This also fostered an environment where APPs were practicing at the top of their licenses and improved job satisfaction.

Additionally, across the hospital medicine division, several APPs were utilized from other divisions to assist with admissions and cross cover. As the volume was at incredibly high levels, this improved the workload and burden of the hospital medicine providers. The displaced APPs were utilized at several facilities and worked under the guidance and supervision of hospital medicine providers. Moving forward, this has prompted leadership to look at utilizing APPs from other divisions as “PRN” providers as well.

Doctors Hospital of Laredo, Texas, and the Laredo Physicians Group have filed a lawsuit against interventional cardiologist Ricardo Cigarroa, MD, alleging that he engaged in anticompetitive conduct over the availability of cardiologists in Laredo.

Also named in the lawsuit are Cigarroa Heart and Vascular Institute, Laredo Texas Hospital Company (doing business as Laredo Medical Center) and Laredo Physician Associates (LPA).

According to the complaint, in August 2020, Doctors Hospital and Laredo Physicians Group began actively recruiting cardiologists to the city of Laredo.

The complaint states that, with more than 260,000 residents, the city should have a minimum of 20 cardiologists. However, Laredo currently has only eight cardiologists and only six are interventional cardiologists. 

The lawsuit alleges that when Dr. Cigarroa got wind of these recruitment efforts, he entered into a conspiracy with the Cigarroa Institute (a cardiology outpatient clinic) and Laredo Medical Center, the largest acute-care hospital in the city, to engage in “anticompetitive and tortious behavior.

“Their conspiracy had a simple but pernicious goal: deprive Doctors Hospital and Physicians Group of the doctors and employees needed to compete and provide interventional cardiology services to the Laredo market,” the complaint reads. 

The alleged conspiracy unfolded in multiple steps, it notes, with Dr. Cigarroa issuing threats to Doctors Hospital, Laredo Physicians Group, and prospective interventional cardiologists being recruited.

Through threats and coercion, multiple qualified interventional cardiologists who were interested in joining Laredo Physicians Group, and to whom the group extended employment offers, decided not to join, the complaint states.

It further claims that Dr. Cigarroa, his son, and his nephew – who represent more than half of the interventional cardiologists in Laredo – informed Doctors Hospital that they would “no longer respond” to emergency calls at Doctors Hospital.

The complaint further alleges that after “scaring off competitors and further cementing their dominant market power and position,” the defendants targeted Arthur Santos, MD, Laredo’s only cardiovascular surgeon who was employed by Laredo Physicians Group.

“Defendants successfully induced Dr. Santos to agree to join Defendant Laredo Physicians Associates (LPA), breaching his enforceable noncompete contractual provision,” the complaint states.

The defendants then allegedly induced the cardiothoracic surgery technicians at Doctors Hospital to join Laredo Medical Center (LMC) and work with Dr. Cigarroa and Dr. Santos, the complaint says.

“The conspiracy to monopolize Laredo’s interventional cardiology market is a win-win-win for Defendants. Dr Cigarroa and the clinic avoid competition for interventional cardiological services, while LMC is left as the only provider of acute cardiology services in Laredo, gaining additional patients and corresponding increased revenue,” the complaint reads.

“Meanwhile, Doctors Hospital’s acute-care cardiology program will be threatened with extinction and, critically, Laredo patients are left with higher health care costs and greater health risks and without competitive market alternatives,” it states.
 

Dr. Cigarroa responds

According to the Laredo Times, in a statement responding to the anticompetitive conduct lawsuit, Dr. Cigarroa said: “This lawsuit is a dispute between a for-profit corporation and a physician who has demonstrated over 30 years of commitment to his patients and patient care in this community.

“It’s unfortunate that the executives [at] Doctors Hospital have chosen to put profit above the well-being of their patients and employees. Their actions confirm that they care more about their bottom line than they do about our residents and reaffirms how disconnected they are from our community,” Dr. Cigarroa said.

“My top priority continues to be the health of all Laredo residents. I will never stop caring for the patients that I love, and I will continue to help save lives,” Dr. Cigarroa said, according to the Times article.

“I am humbled to have received numerous calls of support from many Doctors Hospital employees. Their words of encouragement are a true testament to the strong relationships I have within the medical community,” Dr. Cigarroa added.

A version of this article first appeared on Medscape.com.

Doctors Hospital of Laredo, Texas, and the Laredo Physicians Group have filed a lawsuit against interventional cardiologist Ricardo Cigarroa, MD, alleging that he engaged in anticompetitive conduct over the availability of cardiologists in Laredo.

Also named in the lawsuit are Cigarroa Heart and Vascular Institute, Laredo Texas Hospital Company (doing business as Laredo Medical Center) and Laredo Physician Associates (LPA).

According to the complaint, in August 2020, Doctors Hospital and Laredo Physicians Group began actively recruiting cardiologists to the city of Laredo.

The complaint states that, with more than 260,000 residents, the city should have a minimum of 20 cardiologists. However, Laredo currently has only eight cardiologists and only six are interventional cardiologists. 

The lawsuit alleges that when Dr. Cigarroa got wind of these recruitment efforts, he entered into a conspiracy with the Cigarroa Institute (a cardiology outpatient clinic) and Laredo Medical Center, the largest acute-care hospital in the city, to engage in “anticompetitive and tortious behavior.

“Their conspiracy had a simple but pernicious goal: deprive Doctors Hospital and Physicians Group of the doctors and employees needed to compete and provide interventional cardiology services to the Laredo market,” the complaint reads. 

The alleged conspiracy unfolded in multiple steps, it notes, with Dr. Cigarroa issuing threats to Doctors Hospital, Laredo Physicians Group, and prospective interventional cardiologists being recruited.

Through threats and coercion, multiple qualified interventional cardiologists who were interested in joining Laredo Physicians Group, and to whom the group extended employment offers, decided not to join, the complaint states.

It further claims that Dr. Cigarroa, his son, and his nephew – who represent more than half of the interventional cardiologists in Laredo – informed Doctors Hospital that they would “no longer respond” to emergency calls at Doctors Hospital.

The complaint further alleges that after “scaring off competitors and further cementing their dominant market power and position,” the defendants targeted Arthur Santos, MD, Laredo’s only cardiovascular surgeon who was employed by Laredo Physicians Group.

“Defendants successfully induced Dr. Santos to agree to join Defendant Laredo Physicians Associates (LPA), breaching his enforceable noncompete contractual provision,” the complaint states.

The defendants then allegedly induced the cardiothoracic surgery technicians at Doctors Hospital to join Laredo Medical Center (LMC) and work with Dr. Cigarroa and Dr. Santos, the complaint says.

“The conspiracy to monopolize Laredo’s interventional cardiology market is a win-win-win for Defendants. Dr Cigarroa and the clinic avoid competition for interventional cardiological services, while LMC is left as the only provider of acute cardiology services in Laredo, gaining additional patients and corresponding increased revenue,” the complaint reads.

“Meanwhile, Doctors Hospital’s acute-care cardiology program will be threatened with extinction and, critically, Laredo patients are left with higher health care costs and greater health risks and without competitive market alternatives,” it states.
 

Dr. Cigarroa responds

According to the Laredo Times, in a statement responding to the anticompetitive conduct lawsuit, Dr. Cigarroa said: “This lawsuit is a dispute between a for-profit corporation and a physician who has demonstrated over 30 years of commitment to his patients and patient care in this community.

“It’s unfortunate that the executives [at] Doctors Hospital have chosen to put profit above the well-being of their patients and employees. Their actions confirm that they care more about their bottom line than they do about our residents and reaffirms how disconnected they are from our community,” Dr. Cigarroa said.

“My top priority continues to be the health of all Laredo residents. I will never stop caring for the patients that I love, and I will continue to help save lives,” Dr. Cigarroa said, according to the Times article.

“I am humbled to have received numerous calls of support from many Doctors Hospital employees. Their words of encouragement are a true testament to the strong relationships I have within the medical community,” Dr. Cigarroa added.

A version of this article first appeared on Medscape.com.

Doctors Hospital of Laredo, Texas, and the Laredo Physicians Group have filed a lawsuit against interventional cardiologist Ricardo Cigarroa, MD, alleging that he engaged in anticompetitive conduct over the availability of cardiologists in Laredo.

Also named in the lawsuit are Cigarroa Heart and Vascular Institute, Laredo Texas Hospital Company (doing business as Laredo Medical Center) and Laredo Physician Associates (LPA).

According to the complaint, in August 2020, Doctors Hospital and Laredo Physicians Group began actively recruiting cardiologists to the city of Laredo.

The complaint states that, with more than 260,000 residents, the city should have a minimum of 20 cardiologists. However, Laredo currently has only eight cardiologists and only six are interventional cardiologists. 

The lawsuit alleges that when Dr. Cigarroa got wind of these recruitment efforts, he entered into a conspiracy with the Cigarroa Institute (a cardiology outpatient clinic) and Laredo Medical Center, the largest acute-care hospital in the city, to engage in “anticompetitive and tortious behavior.

“Their conspiracy had a simple but pernicious goal: deprive Doctors Hospital and Physicians Group of the doctors and employees needed to compete and provide interventional cardiology services to the Laredo market,” the complaint reads. 

The alleged conspiracy unfolded in multiple steps, it notes, with Dr. Cigarroa issuing threats to Doctors Hospital, Laredo Physicians Group, and prospective interventional cardiologists being recruited.

Through threats and coercion, multiple qualified interventional cardiologists who were interested in joining Laredo Physicians Group, and to whom the group extended employment offers, decided not to join, the complaint states.

It further claims that Dr. Cigarroa, his son, and his nephew – who represent more than half of the interventional cardiologists in Laredo – informed Doctors Hospital that they would “no longer respond” to emergency calls at Doctors Hospital.

The complaint further alleges that after “scaring off competitors and further cementing their dominant market power and position,” the defendants targeted Arthur Santos, MD, Laredo’s only cardiovascular surgeon who was employed by Laredo Physicians Group.

“Defendants successfully induced Dr. Santos to agree to join Defendant Laredo Physicians Associates (LPA), breaching his enforceable noncompete contractual provision,” the complaint states.

The defendants then allegedly induced the cardiothoracic surgery technicians at Doctors Hospital to join Laredo Medical Center (LMC) and work with Dr. Cigarroa and Dr. Santos, the complaint says.

“The conspiracy to monopolize Laredo’s interventional cardiology market is a win-win-win for Defendants. Dr Cigarroa and the clinic avoid competition for interventional cardiological services, while LMC is left as the only provider of acute cardiology services in Laredo, gaining additional patients and corresponding increased revenue,” the complaint reads.

“Meanwhile, Doctors Hospital’s acute-care cardiology program will be threatened with extinction and, critically, Laredo patients are left with higher health care costs and greater health risks and without competitive market alternatives,” it states.
 

Dr. Cigarroa responds

According to the Laredo Times, in a statement responding to the anticompetitive conduct lawsuit, Dr. Cigarroa said: “This lawsuit is a dispute between a for-profit corporation and a physician who has demonstrated over 30 years of commitment to his patients and patient care in this community.

“It’s unfortunate that the executives [at] Doctors Hospital have chosen to put profit above the well-being of their patients and employees. Their actions confirm that they care more about their bottom line than they do about our residents and reaffirms how disconnected they are from our community,” Dr. Cigarroa said.

“My top priority continues to be the health of all Laredo residents. I will never stop caring for the patients that I love, and I will continue to help save lives,” Dr. Cigarroa said, according to the Times article.

“I am humbled to have received numerous calls of support from many Doctors Hospital employees. Their words of encouragement are a true testament to the strong relationships I have within the medical community,” Dr. Cigarroa added.

A version of this article first appeared on Medscape.com.