Study Title

The impact of a High Value Care curriculum on rate of repeat of trans-thoracic echocardiogram ordering among medical residents

Background

There is little data to confirm the impact of a High Value Care curriculum on echocardiogram ordering practices in a residency training program. We sought to evaluate the rate of performance of repeat transthoracic echocardiograms (TTE) before and after implementation of a High Vale Care curriculum.

Methods

A High Value Care curriculum was developed for the medical residents at Griffin Hospital, a community hospital, in 2015. The curriculum included a series of lectures aimed at promoting cost-conscious care while maintaining high quality. It also involved house staff in different quality improvement (QI) projects aimed at promoting high value care.

A group of residents decided to work on an initiative to reduce repeat echocardiograms. Repeat echocardiograms were defined as those performed within 6 months of a previous echocardiogram on the same patient. Only results in our EHR reflecting in-patient echocardiograms were utilized.

We retrospectively examined the rates of repeat echocardiograms performed in a 6 month period in 2014 before the High Vale Care curriculum was initiated. We assessed data from a 5 month period in 2016 to determine the rate of repeat electrocardiograms ordered at our institution.
 

Results

A total of 1,709 echocardiograms were reviewed in both time periods. Of these, 275 were considered repeat. At baseline, or before the implementation of a High Value Care curriculum, we examined 908 echocardiograms that were ordered, of which 21% were repeats.

After the implementation of a High Vale Care curriculum, 801 echocardiograms were ordered. Only 11% of these were repeats. This corresponds to a 52% reduction in the rate of repeated ordering of echocardiograms.

Discussion

The significant improvement in the rate of repeat echocardiograms was noted without any initiative directed specifically at echocardiogram ordering practices. During the planning phases of the proposed QI initiative to reduce repeat echocardiograms, house staff noted that their colleagues were already being more selective in their echocardiogram ordering practices because of the impact of the-cost conscious care lectures they had attended, as well as hospital-wide attention on the first resident-driven QI initiative that was aimed at reducing repetitive daily labs.

As part of the reducing repetitive labs QI, house staff had to provide clear rationale for why they were ordering daily labs. The received regular updates about their lab ordering practices and direct feedback if they consistently did not provide clear rationale for ordering daily labs.

Conclusion

Our study clearly showed a greater than 50% reduction in the ordering of repeat echocardiograms because of a High Value Care curriculum in our residency training program.

The improvement was brought on by increased awareness by house staff regarding provision of high quality care while being cognizant of the costs involved. The reduction in repeat echocardiograms resulted in more efficient use of a limited hospital resource.

Dr. Arole is chief of hospital medicine at Griffin Hospital, Derby, Conn. Dr. Zyed is in the department of internal medicine at Griffin Hospital. Dr. Njike is with the Yale University Prevention Research Center at Griffin Hospital.

Study Title

The impact of a High Value Care curriculum on rate of repeat of trans-thoracic echocardiogram ordering among medical residents

Background

There is little data to confirm the impact of a High Value Care curriculum on echocardiogram ordering practices in a residency training program. We sought to evaluate the rate of performance of repeat transthoracic echocardiograms (TTE) before and after implementation of a High Vale Care curriculum.

Methods

A High Value Care curriculum was developed for the medical residents at Griffin Hospital, a community hospital, in 2015. The curriculum included a series of lectures aimed at promoting cost-conscious care while maintaining high quality. It also involved house staff in different quality improvement (QI) projects aimed at promoting high value care.

A group of residents decided to work on an initiative to reduce repeat echocardiograms. Repeat echocardiograms were defined as those performed within 6 months of a previous echocardiogram on the same patient. Only results in our EHR reflecting in-patient echocardiograms were utilized.

We retrospectively examined the rates of repeat echocardiograms performed in a 6 month period in 2014 before the High Vale Care curriculum was initiated. We assessed data from a 5 month period in 2016 to determine the rate of repeat electrocardiograms ordered at our institution.
 

Results

A total of 1,709 echocardiograms were reviewed in both time periods. Of these, 275 were considered repeat. At baseline, or before the implementation of a High Value Care curriculum, we examined 908 echocardiograms that were ordered, of which 21% were repeats.

After the implementation of a High Vale Care curriculum, 801 echocardiograms were ordered. Only 11% of these were repeats. This corresponds to a 52% reduction in the rate of repeated ordering of echocardiograms.

Discussion

The significant improvement in the rate of repeat echocardiograms was noted without any initiative directed specifically at echocardiogram ordering practices. During the planning phases of the proposed QI initiative to reduce repeat echocardiograms, house staff noted that their colleagues were already being more selective in their echocardiogram ordering practices because of the impact of the-cost conscious care lectures they had attended, as well as hospital-wide attention on the first resident-driven QI initiative that was aimed at reducing repetitive daily labs.

As part of the reducing repetitive labs QI, house staff had to provide clear rationale for why they were ordering daily labs. The received regular updates about their lab ordering practices and direct feedback if they consistently did not provide clear rationale for ordering daily labs.

Conclusion

Our study clearly showed a greater than 50% reduction in the ordering of repeat echocardiograms because of a High Value Care curriculum in our residency training program.

The improvement was brought on by increased awareness by house staff regarding provision of high quality care while being cognizant of the costs involved. The reduction in repeat echocardiograms resulted in more efficient use of a limited hospital resource.

Dr. Arole is chief of hospital medicine at Griffin Hospital, Derby, Conn. Dr. Zyed is in the department of internal medicine at Griffin Hospital. Dr. Njike is with the Yale University Prevention Research Center at Griffin Hospital.

Study Title

The impact of a High Value Care curriculum on rate of repeat of trans-thoracic echocardiogram ordering among medical residents

Background

There is little data to confirm the impact of a High Value Care curriculum on echocardiogram ordering practices in a residency training program. We sought to evaluate the rate of performance of repeat transthoracic echocardiograms (TTE) before and after implementation of a High Vale Care curriculum.

Methods

A High Value Care curriculum was developed for the medical residents at Griffin Hospital, a community hospital, in 2015. The curriculum included a series of lectures aimed at promoting cost-conscious care while maintaining high quality. It also involved house staff in different quality improvement (QI) projects aimed at promoting high value care.

A group of residents decided to work on an initiative to reduce repeat echocardiograms. Repeat echocardiograms were defined as those performed within 6 months of a previous echocardiogram on the same patient. Only results in our EHR reflecting in-patient echocardiograms were utilized.

We retrospectively examined the rates of repeat echocardiograms performed in a 6 month period in 2014 before the High Vale Care curriculum was initiated. We assessed data from a 5 month period in 2016 to determine the rate of repeat electrocardiograms ordered at our institution.
 

Results

A total of 1,709 echocardiograms were reviewed in both time periods. Of these, 275 were considered repeat. At baseline, or before the implementation of a High Value Care curriculum, we examined 908 echocardiograms that were ordered, of which 21% were repeats.

After the implementation of a High Vale Care curriculum, 801 echocardiograms were ordered. Only 11% of these were repeats. This corresponds to a 52% reduction in the rate of repeated ordering of echocardiograms.

Discussion

The significant improvement in the rate of repeat echocardiograms was noted without any initiative directed specifically at echocardiogram ordering practices. During the planning phases of the proposed QI initiative to reduce repeat echocardiograms, house staff noted that their colleagues were already being more selective in their echocardiogram ordering practices because of the impact of the-cost conscious care lectures they had attended, as well as hospital-wide attention on the first resident-driven QI initiative that was aimed at reducing repetitive daily labs.

As part of the reducing repetitive labs QI, house staff had to provide clear rationale for why they were ordering daily labs. The received regular updates about their lab ordering practices and direct feedback if they consistently did not provide clear rationale for ordering daily labs.

Conclusion

Our study clearly showed a greater than 50% reduction in the ordering of repeat echocardiograms because of a High Value Care curriculum in our residency training program.

The improvement was brought on by increased awareness by house staff regarding provision of high quality care while being cognizant of the costs involved. The reduction in repeat echocardiograms resulted in more efficient use of a limited hospital resource.

Dr. Arole is chief of hospital medicine at Griffin Hospital, Derby, Conn. Dr. Zyed is in the department of internal medicine at Griffin Hospital. Dr. Njike is with the Yale University Prevention Research Center at Griffin Hospital.

A new tumor immune-related gene signature may help take the guesswork out of prognostication in patients with early-stage non–small cell lung cancer (NSCLC), according to a retrospective cohort study.

“Various components of the immune system have been shown to be a determining factor during cancer initiation and progression,” note the investigators, who were led by Bailiang Li, PhD, of Stanford (Calif.) University. “Recent immunotherapies targeting specific immune checkpoints such as programmed death 1 or programmed death ligand 1 have demonstrated a remarkable, durable response in NSCLC. Certain histopathologic patterns, such as intratumoral infiltration by cytotoxic lymphocytes, have also been associated with better prognoses in several cancer types, including NSCLC.”

For the study, the investigators developed and validated an immune-related gene signature using frozen tumors from 2,414 patients with stage I or II nonsquamous NSCLC from 19 public cohorts who underwent resection with negative margins and did not receive any neoadjuvant or adjuvant therapy.

The new signature contained 25 gene pairs consisting of 40 unique immune-related genes, Dr. Li and associates report (JAMA Oncol. 2017 Jul 6. doi: 10.1001/jamaoncol.2017.1609).

Processes such as chemotaxis were enriched among the included genes.

The signature significantly stratified patients into groups that have high and low risks of death during follow-up, both across and within subsets with stage I, IA, IB, or II disease. Relative to counterparts falling into the signature-defined low-risk group, those falling into the signature-defined high-risk group had roughly twice the risk of death after adjustment for clinical and pathologic characteristics, with a hazard ratio range of 1.72 (P less than .001) to 2.36 (P less than .001).

Accuracy of the immune signature exceeded that of two commercialized gene signatures for estimating survival in similar validation cohorts (mean concordance index [C-index], 0.64 vs 0.53 and 0.61).

Moreover, the combination of the immune signature with clinical factors outperformed the signature alone (mean C-index, 0.70 vs 0.63) and another commercialized clinical-molecular combination signature (mean C-index, 0.68 vs 0.65).

“The proposed immune-related gene pair–based signature is a promising prognostic biomarker in nonsquamous NSCLC, including early-stage disease,” concluded the investigators. “Prospective studies are needed to further validate its analytical accuracy for estimating prognoses and to test its clinical utility in individualized management of nonsquamous NSCLC.”

A new tumor immune-related gene signature may help take the guesswork out of prognostication in patients with early-stage non–small cell lung cancer (NSCLC), according to a retrospective cohort study.

“Various components of the immune system have been shown to be a determining factor during cancer initiation and progression,” note the investigators, who were led by Bailiang Li, PhD, of Stanford (Calif.) University. “Recent immunotherapies targeting specific immune checkpoints such as programmed death 1 or programmed death ligand 1 have demonstrated a remarkable, durable response in NSCLC. Certain histopathologic patterns, such as intratumoral infiltration by cytotoxic lymphocytes, have also been associated with better prognoses in several cancer types, including NSCLC.”

For the study, the investigators developed and validated an immune-related gene signature using frozen tumors from 2,414 patients with stage I or II nonsquamous NSCLC from 19 public cohorts who underwent resection with negative margins and did not receive any neoadjuvant or adjuvant therapy.

The new signature contained 25 gene pairs consisting of 40 unique immune-related genes, Dr. Li and associates report (JAMA Oncol. 2017 Jul 6. doi: 10.1001/jamaoncol.2017.1609).

Processes such as chemotaxis were enriched among the included genes.

The signature significantly stratified patients into groups that have high and low risks of death during follow-up, both across and within subsets with stage I, IA, IB, or II disease. Relative to counterparts falling into the signature-defined low-risk group, those falling into the signature-defined high-risk group had roughly twice the risk of death after adjustment for clinical and pathologic characteristics, with a hazard ratio range of 1.72 (P less than .001) to 2.36 (P less than .001).

Accuracy of the immune signature exceeded that of two commercialized gene signatures for estimating survival in similar validation cohorts (mean concordance index [C-index], 0.64 vs 0.53 and 0.61).

Moreover, the combination of the immune signature with clinical factors outperformed the signature alone (mean C-index, 0.70 vs 0.63) and another commercialized clinical-molecular combination signature (mean C-index, 0.68 vs 0.65).

“The proposed immune-related gene pair–based signature is a promising prognostic biomarker in nonsquamous NSCLC, including early-stage disease,” concluded the investigators. “Prospective studies are needed to further validate its analytical accuracy for estimating prognoses and to test its clinical utility in individualized management of nonsquamous NSCLC.”

A new tumor immune-related gene signature may help take the guesswork out of prognostication in patients with early-stage non–small cell lung cancer (NSCLC), according to a retrospective cohort study.

“Various components of the immune system have been shown to be a determining factor during cancer initiation and progression,” note the investigators, who were led by Bailiang Li, PhD, of Stanford (Calif.) University. “Recent immunotherapies targeting specific immune checkpoints such as programmed death 1 or programmed death ligand 1 have demonstrated a remarkable, durable response in NSCLC. Certain histopathologic patterns, such as intratumoral infiltration by cytotoxic lymphocytes, have also been associated with better prognoses in several cancer types, including NSCLC.”

For the study, the investigators developed and validated an immune-related gene signature using frozen tumors from 2,414 patients with stage I or II nonsquamous NSCLC from 19 public cohorts who underwent resection with negative margins and did not receive any neoadjuvant or adjuvant therapy.

The new signature contained 25 gene pairs consisting of 40 unique immune-related genes, Dr. Li and associates report (JAMA Oncol. 2017 Jul 6. doi: 10.1001/jamaoncol.2017.1609).

Processes such as chemotaxis were enriched among the included genes.

The signature significantly stratified patients into groups that have high and low risks of death during follow-up, both across and within subsets with stage I, IA, IB, or II disease. Relative to counterparts falling into the signature-defined low-risk group, those falling into the signature-defined high-risk group had roughly twice the risk of death after adjustment for clinical and pathologic characteristics, with a hazard ratio range of 1.72 (P less than .001) to 2.36 (P less than .001).

Accuracy of the immune signature exceeded that of two commercialized gene signatures for estimating survival in similar validation cohorts (mean concordance index [C-index], 0.64 vs 0.53 and 0.61).

Moreover, the combination of the immune signature with clinical factors outperformed the signature alone (mean C-index, 0.70 vs 0.63) and another commercialized clinical-molecular combination signature (mean C-index, 0.68 vs 0.65).

“The proposed immune-related gene pair–based signature is a promising prognostic biomarker in nonsquamous NSCLC, including early-stage disease,” concluded the investigators. “Prospective studies are needed to further validate its analytical accuracy for estimating prognoses and to test its clinical utility in individualized management of nonsquamous NSCLC.”

The Centers for Medicare & Medicaid Services survey period is upon us, and it’s time for dermatologists in nine test states to act.

In my April column, I discussed the CMS survey, which is intended to gather data on when follow-up visits for surgical procedures take place. Reporting started July 1st and will continue for several months, at least, possibly for a year.

Thinkstock

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

The Centers for Medicare & Medicaid Services survey period is upon us, and it’s time for dermatologists in nine test states to act.

In my April column, I discussed the CMS survey, which is intended to gather data on when follow-up visits for surgical procedures take place. Reporting started July 1st and will continue for several months, at least, possibly for a year.

Thinkstock

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

The Centers for Medicare & Medicaid Services survey period is upon us, and it’s time for dermatologists in nine test states to act.

In my April column, I discussed the CMS survey, which is intended to gather data on when follow-up visits for surgical procedures take place. Reporting started July 1st and will continue for several months, at least, possibly for a year.

Thinkstock

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

Does your work make you sick? If it does, do you have paid sick leave? A NIOSH study found that aspects of anoccupation influences people’s health in a multitude of ways, including work conditions, how the work is organized, job-related tasks, long work hours, and work-life balance. “Work is an important determinant of health,” the researchers conclude.

NIOSH researchers analyzed data from 10,767 adults in many occupations who participated in the 2010 National Health Interview Survey. People employed in business operations jobs, such as marketing and human resources, were 85% more likely to rate their health as fair or poor. Workers with no paid sick leave were 35% more likely to report fair or poor health. Workers who were worried about becoming unemployed were 43% more likely to report fair or poor health. Those who reported difficulty combining work and family were 23% more likely. Those who reported being bullied at work were 82% more likely.

“We believe this is the first study to show an association between business operations jobs and poor health,” said Sara Luckhaupt, MD, NIOSH medical officer and lead author of the study. “Knowing which aspects of a person’s job can lead to poor health can help public health and employee wellness professionals develop—ideally with worker input—tailored workplace interventions to advance worker well-being.”

Does your work make you sick? If it does, do you have paid sick leave? A NIOSH study found that aspects of anoccupation influences people’s health in a multitude of ways, including work conditions, how the work is organized, job-related tasks, long work hours, and work-life balance. “Work is an important determinant of health,” the researchers conclude.

NIOSH researchers analyzed data from 10,767 adults in many occupations who participated in the 2010 National Health Interview Survey. People employed in business operations jobs, such as marketing and human resources, were 85% more likely to rate their health as fair or poor. Workers with no paid sick leave were 35% more likely to report fair or poor health. Workers who were worried about becoming unemployed were 43% more likely to report fair or poor health. Those who reported difficulty combining work and family were 23% more likely. Those who reported being bullied at work were 82% more likely.

“We believe this is the first study to show an association between business operations jobs and poor health,” said Sara Luckhaupt, MD, NIOSH medical officer and lead author of the study. “Knowing which aspects of a person’s job can lead to poor health can help public health and employee wellness professionals develop—ideally with worker input—tailored workplace interventions to advance worker well-being.”

Does your work make you sick? If it does, do you have paid sick leave? A NIOSH study found that aspects of anoccupation influences people’s health in a multitude of ways, including work conditions, how the work is organized, job-related tasks, long work hours, and work-life balance. “Work is an important determinant of health,” the researchers conclude.

NIOSH researchers analyzed data from 10,767 adults in many occupations who participated in the 2010 National Health Interview Survey. People employed in business operations jobs, such as marketing and human resources, were 85% more likely to rate their health as fair or poor. Workers with no paid sick leave were 35% more likely to report fair or poor health. Workers who were worried about becoming unemployed were 43% more likely to report fair or poor health. Those who reported difficulty combining work and family were 23% more likely. Those who reported being bullied at work were 82% more likely.

“We believe this is the first study to show an association between business operations jobs and poor health,” said Sara Luckhaupt, MD, NIOSH medical officer and lead author of the study. “Knowing which aspects of a person’s job can lead to poor health can help public health and employee wellness professionals develop—ideally with worker input—tailored workplace interventions to advance worker well-being.”

Carfilzomib, a selective second-generation proteasome inhibitor, has performed well in clinical trials. So because other “triplets”—combinations of alkylator, proteasome inhibitor, and steroid—had shown “encouraging” response rates, researchers from the Center for Cancer and Blood Disorders in Bethesda, Maryland, and others, conducted a multicenter study to evaluate the safety and tolerability of twice-weekly carfilzomib combined with cyclophosphamide and dexamethasone (KCyd) for patients newly diagnosed with multiple myeloma (MM).

The researchers tested 3 doses of carfilzomib: 36 mg/m², 45 mg/m², and 56 mg/m². Of the 22 enrolled patients, 16 were treated with the maximum dose.

Fourteen patients completed all 8 cycles of treatment; 10 in the maximum-dose group completed all 8. At 56 mg/m², the overall response rate was 87.5%. Among the 14 patients whose disease responded to therapy, the median time to response was 1 month.

Five patients discontinued treatment because of adverse effects (AEs), but the researchers found no dose-limiting toxicities at any of the dose levels. The most common AEs were nausea, diarrhea, and anemia.

The researchers concluded that based on previous research, KCyd with 36 mg/m² is safe and effective in patients aged ≥ 65 years with newly diagnosed MM. However, their findings suggest that twice-weekly carfilzomib 56 mg/m² in combination with cyclophosphamide and dexamethasone also is effective with “manageable toxicity.”

Source:
Boccia RV, Bessudo A, Agajanian R, et al. Clin Lymphoma Myeloma Leuk. In press.
doi: 10.1016/j.clml.2017.05.009.

Carfilzomib, a selective second-generation proteasome inhibitor, has performed well in clinical trials. So because other “triplets”—combinations of alkylator, proteasome inhibitor, and steroid—had shown “encouraging” response rates, researchers from the Center for Cancer and Blood Disorders in Bethesda, Maryland, and others, conducted a multicenter study to evaluate the safety and tolerability of twice-weekly carfilzomib combined with cyclophosphamide and dexamethasone (KCyd) for patients newly diagnosed with multiple myeloma (MM).

The researchers tested 3 doses of carfilzomib: 36 mg/m², 45 mg/m², and 56 mg/m². Of the 22 enrolled patients, 16 were treated with the maximum dose.

Fourteen patients completed all 8 cycles of treatment; 10 in the maximum-dose group completed all 8. At 56 mg/m², the overall response rate was 87.5%. Among the 14 patients whose disease responded to therapy, the median time to response was 1 month.

Five patients discontinued treatment because of adverse effects (AEs), but the researchers found no dose-limiting toxicities at any of the dose levels. The most common AEs were nausea, diarrhea, and anemia.

The researchers concluded that based on previous research, KCyd with 36 mg/m² is safe and effective in patients aged ≥ 65 years with newly diagnosed MM. However, their findings suggest that twice-weekly carfilzomib 56 mg/m² in combination with cyclophosphamide and dexamethasone also is effective with “manageable toxicity.”

Source:
Boccia RV, Bessudo A, Agajanian R, et al. Clin Lymphoma Myeloma Leuk. In press.
doi: 10.1016/j.clml.2017.05.009.

Carfilzomib, a selective second-generation proteasome inhibitor, has performed well in clinical trials. So because other “triplets”—combinations of alkylator, proteasome inhibitor, and steroid—had shown “encouraging” response rates, researchers from the Center for Cancer and Blood Disorders in Bethesda, Maryland, and others, conducted a multicenter study to evaluate the safety and tolerability of twice-weekly carfilzomib combined with cyclophosphamide and dexamethasone (KCyd) for patients newly diagnosed with multiple myeloma (MM).

The researchers tested 3 doses of carfilzomib: 36 mg/m², 45 mg/m², and 56 mg/m². Of the 22 enrolled patients, 16 were treated with the maximum dose.

Fourteen patients completed all 8 cycles of treatment; 10 in the maximum-dose group completed all 8. At 56 mg/m², the overall response rate was 87.5%. Among the 14 patients whose disease responded to therapy, the median time to response was 1 month.

Five patients discontinued treatment because of adverse effects (AEs), but the researchers found no dose-limiting toxicities at any of the dose levels. The most common AEs were nausea, diarrhea, and anemia.

The researchers concluded that based on previous research, KCyd with 36 mg/m² is safe and effective in patients aged ≥ 65 years with newly diagnosed MM. However, their findings suggest that twice-weekly carfilzomib 56 mg/m² in combination with cyclophosphamide and dexamethasone also is effective with “manageable toxicity.”

Source:
Boccia RV, Bessudo A, Agajanian R, et al. Clin Lymphoma Myeloma Leuk. In press.
doi: 10.1016/j.clml.2017.05.009.

Image by AJ Cann

BERLIN—Researchers have reported positive results from an ongoing phase 2 trial of fitusiran in patients with hemophilia A or B, with or without inhibitors.

Once-monthly treatment with fitusiran reduced the median annualized bleeding rate (ABR) from 20 to 1 in all patients. In patients with inhibitors, the median ABR fell from 38 to 0.

Most adverse events (AEs) were mild or moderate in severity, with the most common AEs being alanine aminotransferase (ALT) increases and injection-site reactions.

These results were presented* at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress.

The research was sponsored by Alnylam Pharmaceuticals, Inc., the company developing fitusiran in collaboration with Sanofi Genzyme.

Fitusiran is an RNAi therapeutic targeting antithrombin for the treatment of patients with hemophilia A and B. Fitusiran is designed to lower levels of antithrombin and promote sufficient thrombin generation upon activation of the clotting cascade to restore hemostasis and prevent bleeding.

John Pasi, PhD, of Barts and the London School of Medicine and Dentistry in London, UK, and his colleagues tested fitusiran in 33 patients, ages 19 to 61, with hemophilia A (n=27) or hemophilia B (n=6), with inhibitors (n=14) or without (n=19).

Fitusiran was administered as a monthly, subcutaneous, fixed dose of 50 mg (n=13) or 80 mg (n=20).

Patients were treated for up to 20 months, with a median of 11 months on study. Five patients discontinued treatment—4 due to withdrawn consent and 1 due to an AE.

Safety

The incidence of AEs was 70%. Most were mild or moderate in severity and unrelated to fitusiran.

Non-laboratory AEs included injection site reactions (18%, n=6), abdominal pain (9%, n=3), diarrhea (9%, n=3), and headache (9%, n=3).

Eleven patients had asymptomatic ALT increases greater than 3 times the upper limit of normal, without concurrent elevations in bilirubin greater than 2 times the upper limit of normal. All of these patients were hepatitis C antibody-positive.

At last follow-up, all ALT elevations were resolved (n=10) or resolving (n=1).

There were serious AEs in 6 patients, and 2 of these events were considered possibly related to fitusiran. One event was seizure with confusion in a patient with a prior history of seizure disorder.

The other serious AE was an asymptomatic ALT elevation in a patient with chronic hepatitis C virus infection. This patient discontinued treatment due to the event.

There were no thromboembolic events, no laboratory evidence for pathological clot formation, and no instances of anti-drug antibody formation.

Efficacy

Fitusiran resulted in approximately 80% lowering of antithrombin, with corresponding increases in thrombin generation.

In all patients, fitusiran reduced the median ABR from 20 (interquartile range [IQR]: 4-36) to 1 (IQR: 0-3).

In patients with inhibitors, fitusiran reduced the median ABR from 38 (IQR: 20-48) to 0 (IQR: 0-3).

Forty-eight percent of all patients (n=16) remained bleed-free during the observation period, and 67% (n=22) did not experience any spontaneous bleeds.

All breakthrough bleeds were successfully managed with replacement factor (recombinant factor VIII or recombinant factor IX) or bypassing agents (recombinant factor VIIa or activated prothrombin complex concentrate).

Based on these results, Sanofi and Alnylam initiated the ATLAS phase 3 program for fitusiran in patients with hemophilia A and B, with or without inhibitors.

*Data in the abstract differ from data presented at the meeting.

Image by AJ Cann

BERLIN—Researchers have reported positive results from an ongoing phase 2 trial of fitusiran in patients with hemophilia A or B, with or without inhibitors.

Once-monthly treatment with fitusiran reduced the median annualized bleeding rate (ABR) from 20 to 1 in all patients. In patients with inhibitors, the median ABR fell from 38 to 0.

Most adverse events (AEs) were mild or moderate in severity, with the most common AEs being alanine aminotransferase (ALT) increases and injection-site reactions.

These results were presented* at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress.

The research was sponsored by Alnylam Pharmaceuticals, Inc., the company developing fitusiran in collaboration with Sanofi Genzyme.

Fitusiran is an RNAi therapeutic targeting antithrombin for the treatment of patients with hemophilia A and B. Fitusiran is designed to lower levels of antithrombin and promote sufficient thrombin generation upon activation of the clotting cascade to restore hemostasis and prevent bleeding.

John Pasi, PhD, of Barts and the London School of Medicine and Dentistry in London, UK, and his colleagues tested fitusiran in 33 patients, ages 19 to 61, with hemophilia A (n=27) or hemophilia B (n=6), with inhibitors (n=14) or without (n=19).

Fitusiran was administered as a monthly, subcutaneous, fixed dose of 50 mg (n=13) or 80 mg (n=20).

Patients were treated for up to 20 months, with a median of 11 months on study. Five patients discontinued treatment—4 due to withdrawn consent and 1 due to an AE.

Safety

The incidence of AEs was 70%. Most were mild or moderate in severity and unrelated to fitusiran.

Non-laboratory AEs included injection site reactions (18%, n=6), abdominal pain (9%, n=3), diarrhea (9%, n=3), and headache (9%, n=3).

Eleven patients had asymptomatic ALT increases greater than 3 times the upper limit of normal, without concurrent elevations in bilirubin greater than 2 times the upper limit of normal. All of these patients were hepatitis C antibody-positive.

At last follow-up, all ALT elevations were resolved (n=10) or resolving (n=1).

There were serious AEs in 6 patients, and 2 of these events were considered possibly related to fitusiran. One event was seizure with confusion in a patient with a prior history of seizure disorder.

The other serious AE was an asymptomatic ALT elevation in a patient with chronic hepatitis C virus infection. This patient discontinued treatment due to the event.

There were no thromboembolic events, no laboratory evidence for pathological clot formation, and no instances of anti-drug antibody formation.

Efficacy

Fitusiran resulted in approximately 80% lowering of antithrombin, with corresponding increases in thrombin generation.

In all patients, fitusiran reduced the median ABR from 20 (interquartile range [IQR]: 4-36) to 1 (IQR: 0-3).

In patients with inhibitors, fitusiran reduced the median ABR from 38 (IQR: 20-48) to 0 (IQR: 0-3).

Forty-eight percent of all patients (n=16) remained bleed-free during the observation period, and 67% (n=22) did not experience any spontaneous bleeds.

All breakthrough bleeds were successfully managed with replacement factor (recombinant factor VIII or recombinant factor IX) or bypassing agents (recombinant factor VIIa or activated prothrombin complex concentrate).

Based on these results, Sanofi and Alnylam initiated the ATLAS phase 3 program for fitusiran in patients with hemophilia A and B, with or without inhibitors.

*Data in the abstract differ from data presented at the meeting.

Image by AJ Cann

BERLIN—Researchers have reported positive results from an ongoing phase 2 trial of fitusiran in patients with hemophilia A or B, with or without inhibitors.

Once-monthly treatment with fitusiran reduced the median annualized bleeding rate (ABR) from 20 to 1 in all patients. In patients with inhibitors, the median ABR fell from 38 to 0.

Most adverse events (AEs) were mild or moderate in severity, with the most common AEs being alanine aminotransferase (ALT) increases and injection-site reactions.

These results were presented* at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress.

The research was sponsored by Alnylam Pharmaceuticals, Inc., the company developing fitusiran in collaboration with Sanofi Genzyme.

Fitusiran is an RNAi therapeutic targeting antithrombin for the treatment of patients with hemophilia A and B. Fitusiran is designed to lower levels of antithrombin and promote sufficient thrombin generation upon activation of the clotting cascade to restore hemostasis and prevent bleeding.

John Pasi, PhD, of Barts and the London School of Medicine and Dentistry in London, UK, and his colleagues tested fitusiran in 33 patients, ages 19 to 61, with hemophilia A (n=27) or hemophilia B (n=6), with inhibitors (n=14) or without (n=19).

Fitusiran was administered as a monthly, subcutaneous, fixed dose of 50 mg (n=13) or 80 mg (n=20).

Patients were treated for up to 20 months, with a median of 11 months on study. Five patients discontinued treatment—4 due to withdrawn consent and 1 due to an AE.

Safety

The incidence of AEs was 70%. Most were mild or moderate in severity and unrelated to fitusiran.

Non-laboratory AEs included injection site reactions (18%, n=6), abdominal pain (9%, n=3), diarrhea (9%, n=3), and headache (9%, n=3).

Eleven patients had asymptomatic ALT increases greater than 3 times the upper limit of normal, without concurrent elevations in bilirubin greater than 2 times the upper limit of normal. All of these patients were hepatitis C antibody-positive.

At last follow-up, all ALT elevations were resolved (n=10) or resolving (n=1).

There were serious AEs in 6 patients, and 2 of these events were considered possibly related to fitusiran. One event was seizure with confusion in a patient with a prior history of seizure disorder.

The other serious AE was an asymptomatic ALT elevation in a patient with chronic hepatitis C virus infection. This patient discontinued treatment due to the event.

There were no thromboembolic events, no laboratory evidence for pathological clot formation, and no instances of anti-drug antibody formation.

Efficacy

Fitusiran resulted in approximately 80% lowering of antithrombin, with corresponding increases in thrombin generation.

In all patients, fitusiran reduced the median ABR from 20 (interquartile range [IQR]: 4-36) to 1 (IQR: 0-3).

In patients with inhibitors, fitusiran reduced the median ABR from 38 (IQR: 20-48) to 0 (IQR: 0-3).

Forty-eight percent of all patients (n=16) remained bleed-free during the observation period, and 67% (n=22) did not experience any spontaneous bleeds.

All breakthrough bleeds were successfully managed with replacement factor (recombinant factor VIII or recombinant factor IX) or bypassing agents (recombinant factor VIIa or activated prothrombin complex concentrate).

Based on these results, Sanofi and Alnylam initiated the ATLAS phase 3 program for fitusiran in patients with hemophilia A and B, with or without inhibitors.

*Data in the abstract differ from data presented at the meeting.

on Malignant Lymphoma

LUGANO, SWITZERLAND—A 4-drug regimen has demonstrated efficacy in a phase 2 trial of patients with treatment-naïve extranodal natural killer/T-cell lymphoma (ENKTL).

Treatment with gemcitabine, PEG-asparaginase, dexamethasone, and methotrexate (GAD-M) produced a 94% overall response rate (ORR) and an 83% complete response (CR) rate in this trial.

Responses and survival rates were higher in patients with stage I/II disease, who also received radiotherapy, than in patients with stage III/IV disease.

Grade 1/2 toxicities were frequent, but there were few grade 3/4 non-hematologic toxicities. One patient died of treatment-related toxicity.

Zhiming Li, of Sun Yet-sen University Cancer Center in Guangzhou, China, presented these results at the 14th International Conference on Malignant Lymphoma (ICML).

Patients and treatment

The trial enrolled 41 patients with treatment-naïve ENKTL, and 36 of them were evaluable.

The patients’ median age was 45 (range, 18-75), and 30.6% were female. Most patients (86.1%) had stage I/II disease, 13.9% had an ECOG performance status of 2 or greater, and 41.7% had an IPI score of 2 or greater.

The GAD-M regimen consisted of:

• Gemcitabine given at 1000 mg/m² via intravenous drip on days 1 and 8
• PEG-asparaginase given at 2500 U/m² intramuscularly on day 1
• Dexamethasone given at 20 mg via intravenous drip on days 1 to 3
• Methotrexate given at 3000 mg/m² via continuous, 12-hour infusion on day 1.

The regimen was repeated every 3 weeks.

For patients with stage I/II disease, 2 to 4 cycles of the GAD-M regimen was followed by extensive involved-field radiotherapy and an additional 2 to 4 cycles. For patients with stage III/IV disease, GAD-M was repeated for 6 cycles.

Response and survival

The ORR was 94.4%, both after 2 cycles of GAD-M and after 6 cycles. The CR rate was 50% after 2 cycles and 83.3% after 6 cycles.

In patients with stage I/II disease, the ORR was 100% after 2 cycles and 6 cycles. The CR rate was 54.8% after 2 cycles and 90.3% after 6 cycles.

In patients with stage III/IV disease, the ORR was 60% after 2 cycles and 6 cycles. The CR rate was 20% after 2 cycles and 40% after 6 cycles.

At median follow-up of 23.3 months, the estimated 3-year progression-free survival (PFS) was 72.1%, and the overall survival (OS) was 76.3%.

For patients with stage I/II disease, the PFS was 77.3%, and the OS was 79.3%. For patients with stage III/IV disease, the PFS was 40%, and the OS was 60%.

Safety

Hematologic adverse events (AEs) included anemia (97.2% total, 52.8% grade 3/4), leukocytopenia (94.4%, 27.8% grade 3/4), neutropenia (88.9%, 5.6% grade 3), and thrombocytopenia (47.2%, 13.9% grade 3/4).

Non-hematologic AEs included hypoalbuminemia (100%, 5.6% grade 3), increased transaminases (88.9%, 5.6% grade 3), hyperbilirubinemia (52.8%, 11.1% grade 3), decreased fibrinogen (19.4%, 11.1% grade 4), vomiting (13.9%, 2.8% grade 5), increased creatinine (8.3%, 2.8% grade 3), and abdominal pain (5.6% grade 1).

The grade 5 treatment-related AE occurred in a 61-year-old man. He died of electrolyte disorders caused by severe vomiting.

on Malignant Lymphoma

LUGANO, SWITZERLAND—A 4-drug regimen has demonstrated efficacy in a phase 2 trial of patients with treatment-naïve extranodal natural killer/T-cell lymphoma (ENKTL).

Treatment with gemcitabine, PEG-asparaginase, dexamethasone, and methotrexate (GAD-M) produced a 94% overall response rate (ORR) and an 83% complete response (CR) rate in this trial.

Responses and survival rates were higher in patients with stage I/II disease, who also received radiotherapy, than in patients with stage III/IV disease.

Grade 1/2 toxicities were frequent, but there were few grade 3/4 non-hematologic toxicities. One patient died of treatment-related toxicity.

Zhiming Li, of Sun Yet-sen University Cancer Center in Guangzhou, China, presented these results at the 14th International Conference on Malignant Lymphoma (ICML).

Patients and treatment

The trial enrolled 41 patients with treatment-naïve ENKTL, and 36 of them were evaluable.

The patients’ median age was 45 (range, 18-75), and 30.6% were female. Most patients (86.1%) had stage I/II disease, 13.9% had an ECOG performance status of 2 or greater, and 41.7% had an IPI score of 2 or greater.

The GAD-M regimen consisted of:

• Gemcitabine given at 1000 mg/m² via intravenous drip on days 1 and 8
• PEG-asparaginase given at 2500 U/m² intramuscularly on day 1
• Dexamethasone given at 20 mg via intravenous drip on days 1 to 3
• Methotrexate given at 3000 mg/m² via continuous, 12-hour infusion on day 1.

The regimen was repeated every 3 weeks.

For patients with stage I/II disease, 2 to 4 cycles of the GAD-M regimen was followed by extensive involved-field radiotherapy and an additional 2 to 4 cycles. For patients with stage III/IV disease, GAD-M was repeated for 6 cycles.

Response and survival

The ORR was 94.4%, both after 2 cycles of GAD-M and after 6 cycles. The CR rate was 50% after 2 cycles and 83.3% after 6 cycles.

In patients with stage I/II disease, the ORR was 100% after 2 cycles and 6 cycles. The CR rate was 54.8% after 2 cycles and 90.3% after 6 cycles.

In patients with stage III/IV disease, the ORR was 60% after 2 cycles and 6 cycles. The CR rate was 20% after 2 cycles and 40% after 6 cycles.

At median follow-up of 23.3 months, the estimated 3-year progression-free survival (PFS) was 72.1%, and the overall survival (OS) was 76.3%.

For patients with stage I/II disease, the PFS was 77.3%, and the OS was 79.3%. For patients with stage III/IV disease, the PFS was 40%, and the OS was 60%.

Safety

Hematologic adverse events (AEs) included anemia (97.2% total, 52.8% grade 3/4), leukocytopenia (94.4%, 27.8% grade 3/4), neutropenia (88.9%, 5.6% grade 3), and thrombocytopenia (47.2%, 13.9% grade 3/4).

Non-hematologic AEs included hypoalbuminemia (100%, 5.6% grade 3), increased transaminases (88.9%, 5.6% grade 3), hyperbilirubinemia (52.8%, 11.1% grade 3), decreased fibrinogen (19.4%, 11.1% grade 4), vomiting (13.9%, 2.8% grade 5), increased creatinine (8.3%, 2.8% grade 3), and abdominal pain (5.6% grade 1).

The grade 5 treatment-related AE occurred in a 61-year-old man. He died of electrolyte disorders caused by severe vomiting.

on Malignant Lymphoma

LUGANO, SWITZERLAND—A 4-drug regimen has demonstrated efficacy in a phase 2 trial of patients with treatment-naïve extranodal natural killer/T-cell lymphoma (ENKTL).

Treatment with gemcitabine, PEG-asparaginase, dexamethasone, and methotrexate (GAD-M) produced a 94% overall response rate (ORR) and an 83% complete response (CR) rate in this trial.

Responses and survival rates were higher in patients with stage I/II disease, who also received radiotherapy, than in patients with stage III/IV disease.

Grade 1/2 toxicities were frequent, but there were few grade 3/4 non-hematologic toxicities. One patient died of treatment-related toxicity.

Zhiming Li, of Sun Yet-sen University Cancer Center in Guangzhou, China, presented these results at the 14th International Conference on Malignant Lymphoma (ICML).

Patients and treatment

The trial enrolled 41 patients with treatment-naïve ENKTL, and 36 of them were evaluable.

The patients’ median age was 45 (range, 18-75), and 30.6% were female. Most patients (86.1%) had stage I/II disease, 13.9% had an ECOG performance status of 2 or greater, and 41.7% had an IPI score of 2 or greater.

The GAD-M regimen consisted of:

• Gemcitabine given at 1000 mg/m² via intravenous drip on days 1 and 8
• PEG-asparaginase given at 2500 U/m² intramuscularly on day 1
• Dexamethasone given at 20 mg via intravenous drip on days 1 to 3
• Methotrexate given at 3000 mg/m² via continuous, 12-hour infusion on day 1.

The regimen was repeated every 3 weeks.

For patients with stage I/II disease, 2 to 4 cycles of the GAD-M regimen was followed by extensive involved-field radiotherapy and an additional 2 to 4 cycles. For patients with stage III/IV disease, GAD-M was repeated for 6 cycles.

Response and survival

The ORR was 94.4%, both after 2 cycles of GAD-M and after 6 cycles. The CR rate was 50% after 2 cycles and 83.3% after 6 cycles.

In patients with stage I/II disease, the ORR was 100% after 2 cycles and 6 cycles. The CR rate was 54.8% after 2 cycles and 90.3% after 6 cycles.

In patients with stage III/IV disease, the ORR was 60% after 2 cycles and 6 cycles. The CR rate was 20% after 2 cycles and 40% after 6 cycles.

At median follow-up of 23.3 months, the estimated 3-year progression-free survival (PFS) was 72.1%, and the overall survival (OS) was 76.3%.

For patients with stage I/II disease, the PFS was 77.3%, and the OS was 79.3%. For patients with stage III/IV disease, the PFS was 40%, and the OS was 60%.

Safety

Hematologic adverse events (AEs) included anemia (97.2% total, 52.8% grade 3/4), leukocytopenia (94.4%, 27.8% grade 3/4), neutropenia (88.9%, 5.6% grade 3), and thrombocytopenia (47.2%, 13.9% grade 3/4).

Non-hematologic AEs included hypoalbuminemia (100%, 5.6% grade 3), increased transaminases (88.9%, 5.6% grade 3), hyperbilirubinemia (52.8%, 11.1% grade 3), decreased fibrinogen (19.4%, 11.1% grade 4), vomiting (13.9%, 2.8% grade 5), increased creatinine (8.3%, 2.8% grade 3), and abdominal pain (5.6% grade 1).

The grade 5 treatment-related AE occurred in a 61-year-old man. He died of electrolyte disorders caused by severe vomiting.

la Santa Creu i Sant Pau

New research suggests that mutations in the RFWD3 gene cause Fanconi anemia (FA).

Investigators detected mutations in the RFWD3 gene in a child with FA and confirmed the relationship between the mutations and the disorder via functional studies in cell and animal models.

The team described this research in The Journal of Clinical Oncology.

Previously, there was knowledge of 21 genes involved in FA.

“The discovery of new genes is essential not only for genetic diagnosis and advice, but also for the development of new therapies,” said study author Jordi Surrallés, PhD, of the Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.

“The RFWD3 protein is one of the few deficient proteins in patients with Fanconi anemia in which we can see a clear enzymatic activity (ubiquitin ligase), which opens the door to massive drug screenings. In this sense, my group has already worked on several screenings of thousands of therapeutic molecules with the aim of repositioning a drug for this disease.” 

la Santa Creu i Sant Pau

New research suggests that mutations in the RFWD3 gene cause Fanconi anemia (FA).

Investigators detected mutations in the RFWD3 gene in a child with FA and confirmed the relationship between the mutations and the disorder via functional studies in cell and animal models.

The team described this research in The Journal of Clinical Oncology.

Previously, there was knowledge of 21 genes involved in FA.

“The discovery of new genes is essential not only for genetic diagnosis and advice, but also for the development of new therapies,” said study author Jordi Surrallés, PhD, of the Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.

“The RFWD3 protein is one of the few deficient proteins in patients with Fanconi anemia in which we can see a clear enzymatic activity (ubiquitin ligase), which opens the door to massive drug screenings. In this sense, my group has already worked on several screenings of thousands of therapeutic molecules with the aim of repositioning a drug for this disease.” 

la Santa Creu i Sant Pau

New research suggests that mutations in the RFWD3 gene cause Fanconi anemia (FA).

Investigators detected mutations in the RFWD3 gene in a child with FA and confirmed the relationship between the mutations and the disorder via functional studies in cell and animal models.

The team described this research in The Journal of Clinical Oncology.

Previously, there was knowledge of 21 genes involved in FA.

“The discovery of new genes is essential not only for genetic diagnosis and advice, but also for the development of new therapies,” said study author Jordi Surrallés, PhD, of the Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.

“The RFWD3 protein is one of the few deficient proteins in patients with Fanconi anemia in which we can see a clear enzymatic activity (ubiquitin ligase), which opens the door to massive drug screenings. In this sense, my group has already worked on several screenings of thousands of therapeutic molecules with the aim of repositioning a drug for this disease.” 

MADRID – Fatigue is an important symptom in patients with psoriatic arthritis but often goes unaddressed when treatment only involves disease modifying drugs.

A survey of more than 1,000 patients with psoriatic arthritis (PsA) in Denmark found that more than half had moderate or severe levels of fatigue, and a principal component analysis of the sources of fatigue found three factors responsible for the majority of reported patient fatigue: chronic inflammation, chronic pain, and chronification of the PsA, Tanja S. Jørgensen, PhD, said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler
 

MADRID – Fatigue is an important symptom in patients with psoriatic arthritis but often goes unaddressed when treatment only involves disease modifying drugs.

A survey of more than 1,000 patients with psoriatic arthritis (PsA) in Denmark found that more than half had moderate or severe levels of fatigue, and a principal component analysis of the sources of fatigue found three factors responsible for the majority of reported patient fatigue: chronic inflammation, chronic pain, and chronification of the PsA, Tanja S. Jørgensen, PhD, said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler
 

MADRID – Fatigue is an important symptom in patients with psoriatic arthritis but often goes unaddressed when treatment only involves disease modifying drugs.

A survey of more than 1,000 patients with psoriatic arthritis (PsA) in Denmark found that more than half had moderate or severe levels of fatigue, and a principal component analysis of the sources of fatigue found three factors responsible for the majority of reported patient fatigue: chronic inflammation, chronic pain, and chronification of the PsA, Tanja S. Jørgensen, PhD, said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler
 

CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

• Ensuring that the CIN serves community and charitable purposes.
• Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
• Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

[email protected]

On Twitter @legal_med

CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

• Ensuring that the CIN serves community and charitable purposes.
• Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
• Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

[email protected]

On Twitter @legal_med

CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

• Ensuring that the CIN serves community and charitable purposes.
• Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
• Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

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