Patients with mild or moderate Alzheimer’s disease who took nilvadipine experienced increases in cerebral blood flow in the hippocampus, according to a new study.

copyright Radboud University Medical Center

Cerebral blood flow in other regions of the brain did not significantly change in patients who took the antihypertensive drug nilvadipine, according to a report on the trial published in Hypertension. Reduced cerebral blood flow is an early marker of Alzheimer’s disease, and the SPRINT MIND study suggests that intensive blood pressure control may reduce the risk of cognitive impairment.

“These findings [of the new study] not only indicate preserved cerebral autoregulation in Alzheimer’s disease but also point toward beneficial cerebrovascular effects of antihypertensive treatment,” said Jurgen A.H.R. Claassen, MD, PhD of Radboud University Medical Center in Nijmegen, the Netherlands, and coauthors. “An important question is whether this observed increase in [cerebral blood flow] translates to clinical benefits. Unfortunately, sample sizes were too small and follow-up time too short to reliably study the effects ... on structural brain measures and cognitive measures.”

Nilvadipine is a dihydropyridine calcium antagonist used to treat hypertension. In the NILVAD trial, investigators assessed the effects of nilvadipine versus placebo in approximately 500 patients with Alzheimer’s disease. The 18-month trial found no beneficial effects of nilvadipine on cognitive function, but subgroup analyses suggested a potential benefit among patients in the early stages of the disease (PLoS Med. 2018 Sep 24;15[9]:e1002660.).

The cerebral blood flow analysis was a preplanned substudy of NILVAD designed to assess how 6 months of treatment with the drug affects cerebral blood flow as measured using MRI arterial spin labeling. The researchers looked at cerebral blood flow in whole-brain gray matter and in specific regions such as the hippocampus.


The substudy analysis included 22 patients who received nilvadipine and 22 who received placebo during the randomized, double-blind study. Participants had a mean age of 72.8 years and a mean Mini-Mental State Examination score of 20.4.

At 6 months, nilvadipine lowered systolic BP by 11.5 mm Hg, and whole-brain gray matter cerebral blood flow remained stable. Blood flow to the hippocampus increased by approximately 20% among patients treated with nilvadipine – by 24.4 mL/100 g per minute to the left hippocampus and by 20.1 mL/100 g per minute to the right hippocampus.

The increased hippocampal cerebral blood flow could be related to nilvadipine’s antihypertensive effects or its effects on amyloid-beta, the authors noted.

“These findings indicate that the known decrease in [cerebral blood flow] in patients with [Alzheimer’s disease] can in some regions be reversed,” they wrote.

“Even though no medical treatment is without risk, getting treatment for high blood pressure could be important to maintain brain health in patients with Alzheimer’s disease,” Dr. Claassen said in a statement. “In the future, we need to find out whether the improvement in blood flow, especially in the hippocampus, can be used as a supportive treatment to slow down progression of Alzheimer’s disease, especially in earlier states of disease.”

The researchers wrote they lacked biomarkers to confirm Alzheimer’s disease pathology. Most of the study participants were white Europeans, which “limits extrapolation [of the findings] to other populations,” they added.

The Alzheimer’s Drug Discovery Foundation and the Dutch Alzheimer Society funded the NILVAD cerebral blood flow substudy. NILVAD was funded by the European Commission Framework 7 Program Health Theme. Dr. Claassen had no disclosures; one coauthor disclosed a pending patent for nilvadipine.

[email protected]

SOURCE: Claassen JAHR et al. Hypertension. 2019 Jun 17. doi: 10.1161/HYPERTENSIONAHA.119.12892.

Patients with mild or moderate Alzheimer’s disease who took nilvadipine experienced increases in cerebral blood flow in the hippocampus, according to a new study.

copyright Radboud University Medical Center

Cerebral blood flow in other regions of the brain did not significantly change in patients who took the antihypertensive drug nilvadipine, according to a report on the trial published in Hypertension. Reduced cerebral blood flow is an early marker of Alzheimer’s disease, and the SPRINT MIND study suggests that intensive blood pressure control may reduce the risk of cognitive impairment.

“These findings [of the new study] not only indicate preserved cerebral autoregulation in Alzheimer’s disease but also point toward beneficial cerebrovascular effects of antihypertensive treatment,” said Jurgen A.H.R. Claassen, MD, PhD of Radboud University Medical Center in Nijmegen, the Netherlands, and coauthors. “An important question is whether this observed increase in [cerebral blood flow] translates to clinical benefits. Unfortunately, sample sizes were too small and follow-up time too short to reliably study the effects ... on structural brain measures and cognitive measures.”

Nilvadipine is a dihydropyridine calcium antagonist used to treat hypertension. In the NILVAD trial, investigators assessed the effects of nilvadipine versus placebo in approximately 500 patients with Alzheimer’s disease. The 18-month trial found no beneficial effects of nilvadipine on cognitive function, but subgroup analyses suggested a potential benefit among patients in the early stages of the disease (PLoS Med. 2018 Sep 24;15[9]:e1002660.).

The cerebral blood flow analysis was a preplanned substudy of NILVAD designed to assess how 6 months of treatment with the drug affects cerebral blood flow as measured using MRI arterial spin labeling. The researchers looked at cerebral blood flow in whole-brain gray matter and in specific regions such as the hippocampus.


The substudy analysis included 22 patients who received nilvadipine and 22 who received placebo during the randomized, double-blind study. Participants had a mean age of 72.8 years and a mean Mini-Mental State Examination score of 20.4.

At 6 months, nilvadipine lowered systolic BP by 11.5 mm Hg, and whole-brain gray matter cerebral blood flow remained stable. Blood flow to the hippocampus increased by approximately 20% among patients treated with nilvadipine – by 24.4 mL/100 g per minute to the left hippocampus and by 20.1 mL/100 g per minute to the right hippocampus.

The increased hippocampal cerebral blood flow could be related to nilvadipine’s antihypertensive effects or its effects on amyloid-beta, the authors noted.

“These findings indicate that the known decrease in [cerebral blood flow] in patients with [Alzheimer’s disease] can in some regions be reversed,” they wrote.

“Even though no medical treatment is without risk, getting treatment for high blood pressure could be important to maintain brain health in patients with Alzheimer’s disease,” Dr. Claassen said in a statement. “In the future, we need to find out whether the improvement in blood flow, especially in the hippocampus, can be used as a supportive treatment to slow down progression of Alzheimer’s disease, especially in earlier states of disease.”

The researchers wrote they lacked biomarkers to confirm Alzheimer’s disease pathology. Most of the study participants were white Europeans, which “limits extrapolation [of the findings] to other populations,” they added.

The Alzheimer’s Drug Discovery Foundation and the Dutch Alzheimer Society funded the NILVAD cerebral blood flow substudy. NILVAD was funded by the European Commission Framework 7 Program Health Theme. Dr. Claassen had no disclosures; one coauthor disclosed a pending patent for nilvadipine.

[email protected]

SOURCE: Claassen JAHR et al. Hypertension. 2019 Jun 17. doi: 10.1161/HYPERTENSIONAHA.119.12892.

Patients with mild or moderate Alzheimer’s disease who took nilvadipine experienced increases in cerebral blood flow in the hippocampus, according to a new study.

copyright Radboud University Medical Center

Cerebral blood flow in other regions of the brain did not significantly change in patients who took the antihypertensive drug nilvadipine, according to a report on the trial published in Hypertension. Reduced cerebral blood flow is an early marker of Alzheimer’s disease, and the SPRINT MIND study suggests that intensive blood pressure control may reduce the risk of cognitive impairment.

“These findings [of the new study] not only indicate preserved cerebral autoregulation in Alzheimer’s disease but also point toward beneficial cerebrovascular effects of antihypertensive treatment,” said Jurgen A.H.R. Claassen, MD, PhD of Radboud University Medical Center in Nijmegen, the Netherlands, and coauthors. “An important question is whether this observed increase in [cerebral blood flow] translates to clinical benefits. Unfortunately, sample sizes were too small and follow-up time too short to reliably study the effects ... on structural brain measures and cognitive measures.”

Nilvadipine is a dihydropyridine calcium antagonist used to treat hypertension. In the NILVAD trial, investigators assessed the effects of nilvadipine versus placebo in approximately 500 patients with Alzheimer’s disease. The 18-month trial found no beneficial effects of nilvadipine on cognitive function, but subgroup analyses suggested a potential benefit among patients in the early stages of the disease (PLoS Med. 2018 Sep 24;15[9]:e1002660.).

The cerebral blood flow analysis was a preplanned substudy of NILVAD designed to assess how 6 months of treatment with the drug affects cerebral blood flow as measured using MRI arterial spin labeling. The researchers looked at cerebral blood flow in whole-brain gray matter and in specific regions such as the hippocampus.


The substudy analysis included 22 patients who received nilvadipine and 22 who received placebo during the randomized, double-blind study. Participants had a mean age of 72.8 years and a mean Mini-Mental State Examination score of 20.4.

At 6 months, nilvadipine lowered systolic BP by 11.5 mm Hg, and whole-brain gray matter cerebral blood flow remained stable. Blood flow to the hippocampus increased by approximately 20% among patients treated with nilvadipine – by 24.4 mL/100 g per minute to the left hippocampus and by 20.1 mL/100 g per minute to the right hippocampus.

The increased hippocampal cerebral blood flow could be related to nilvadipine’s antihypertensive effects or its effects on amyloid-beta, the authors noted.

“These findings indicate that the known decrease in [cerebral blood flow] in patients with [Alzheimer’s disease] can in some regions be reversed,” they wrote.

“Even though no medical treatment is without risk, getting treatment for high blood pressure could be important to maintain brain health in patients with Alzheimer’s disease,” Dr. Claassen said in a statement. “In the future, we need to find out whether the improvement in blood flow, especially in the hippocampus, can be used as a supportive treatment to slow down progression of Alzheimer’s disease, especially in earlier states of disease.”

The researchers wrote they lacked biomarkers to confirm Alzheimer’s disease pathology. Most of the study participants were white Europeans, which “limits extrapolation [of the findings] to other populations,” they added.

The Alzheimer’s Drug Discovery Foundation and the Dutch Alzheimer Society funded the NILVAD cerebral blood flow substudy. NILVAD was funded by the European Commission Framework 7 Program Health Theme. Dr. Claassen had no disclosures; one coauthor disclosed a pending patent for nilvadipine.

[email protected]

SOURCE: Claassen JAHR et al. Hypertension. 2019 Jun 17. doi: 10.1161/HYPERTENSIONAHA.119.12892.

In this issue of the Journal of Hospital Medicine, McAlister et al.¹ compared the ability of the Clinical Frailty Scale (CFS) and the Hospital Frailty Risk Score (HFRS) to predict 30-day readmission or death. The authors prospectively assessed adult patients aged ≥18 years without cognitive impairment being discharged back to the community after medical admissions. They demonstrated only modest overlap in frailty designation between HFRS and CFS and concluded that CFS is better than HFRS for predicting the outcomes of interest.

Before a prediction rule is widely adopted for use in routine practice, robust external validation is needed.² Factors such as the prevalence of disease in a population, the clinical competencies of a health system, the socioeconomic status, and the ethnicity of the population can all affect how well a clinical rule performs, but may not become apparent until a prospective validation in a different population is attempted.

In developing the HFRS, Gilbert et al. aimed to create a low-cost, highly generalizable method of identifying frailty using International Classification of Diseases (ICD) 10 billing codes.³ The derivation and validation cohorts for HFRS included older adults aged >75 years in the United Kingdom, many of whom had cognitive impairment. Therefore, it is not surprising that the tool behaved very differently in the younger Canadian cohort described by McAlister et al. where persons with cognitive impairment were excluded. That the HFRS had less predictability in the Canadian cohort may simply indicate that it performs better in an older population with cognitive vulnerabilities; given the frailty constructs of the CFS, it may provide less insights in older populations.

We applaud the efforts to find a way to better identify high-risk groups of adults. We also appreciate the increasing attention to function and other frailty-related domains in risk prediction models. Nevertheless, we recommend caution in using any of the many existing frailty indices⁴ in risk prediction tools unless it is clear what domains of frailty are most relevant for the predicted outcome and what population is the subject of interest.

One of the challenges of choosing an appropriate frailty tool is that different tools are measuring different domains or constructs of frailty. Most consider frailty either as a physical phenotype⁵ or as a more multifaceted construct with impairments in physical and mental health, function, and social interaction.⁶ There is often poor overlap between those individuals identified as frail by different measures, highlighting that they are in fact identifying different people within the population studied and have different predictive abilities.

An ideal frailty tool for clinical use would allow clinicians to identify high-risk patients relative to specific outcome(s) in real time prior to discharge from hospital or prior to a sentinel event in the community. CFS can be calculated at the bedside, but HFRS calculation can only be done retrospectively when medical records are coded for claims after discharge. This makes HFRS more suited to research or post hoc quality measure work and CFS more suited to clinical use as the authors describe.

Although using a frailty indicator to help determine those at high risk of early readmission is an important objective, the presence of frailty accounts for only part of a person’s risk for readmission or other untoward events. Reasons for readmissions are complex and often heavily weighted on a lack of social and community supports. A deeper understanding of the reasons for readmission is needed to establish whether readmission of these complex patients has more to do with frailty or other drivers such as poor transitions of care.

The prevalence of frailty will continue to increase as our population ages. Definitions of frailty vary, but there is a broad agreement that frailty, regardless of how it is constructed, increases with age, results in multisystem changes, and leads to increased healthcare utilization and costs. Preventing the development of frailty, identifying frailty, and developing interventions to address frailty in and out of the hospital setting are all vital. We welcome further research regarding the biopsychosocial constructs of frailty, how they overlap with the frailty phenotype, and how these constructs inform both our understanding of frailty and the use of frailty tools.

Disclosures

The authors have no conflicts of interest to report.

In this issue of the Journal of Hospital Medicine, McAlister et al.¹ compared the ability of the Clinical Frailty Scale (CFS) and the Hospital Frailty Risk Score (HFRS) to predict 30-day readmission or death. The authors prospectively assessed adult patients aged ≥18 years without cognitive impairment being discharged back to the community after medical admissions. They demonstrated only modest overlap in frailty designation between HFRS and CFS and concluded that CFS is better than HFRS for predicting the outcomes of interest.

Before a prediction rule is widely adopted for use in routine practice, robust external validation is needed.² Factors such as the prevalence of disease in a population, the clinical competencies of a health system, the socioeconomic status, and the ethnicity of the population can all affect how well a clinical rule performs, but may not become apparent until a prospective validation in a different population is attempted.

In developing the HFRS, Gilbert et al. aimed to create a low-cost, highly generalizable method of identifying frailty using International Classification of Diseases (ICD) 10 billing codes.³ The derivation and validation cohorts for HFRS included older adults aged >75 years in the United Kingdom, many of whom had cognitive impairment. Therefore, it is not surprising that the tool behaved very differently in the younger Canadian cohort described by McAlister et al. where persons with cognitive impairment were excluded. That the HFRS had less predictability in the Canadian cohort may simply indicate that it performs better in an older population with cognitive vulnerabilities; given the frailty constructs of the CFS, it may provide less insights in older populations.

We applaud the efforts to find a way to better identify high-risk groups of adults. We also appreciate the increasing attention to function and other frailty-related domains in risk prediction models. Nevertheless, we recommend caution in using any of the many existing frailty indices⁴ in risk prediction tools unless it is clear what domains of frailty are most relevant for the predicted outcome and what population is the subject of interest.

One of the challenges of choosing an appropriate frailty tool is that different tools are measuring different domains or constructs of frailty. Most consider frailty either as a physical phenotype⁵ or as a more multifaceted construct with impairments in physical and mental health, function, and social interaction.⁶ There is often poor overlap between those individuals identified as frail by different measures, highlighting that they are in fact identifying different people within the population studied and have different predictive abilities.

An ideal frailty tool for clinical use would allow clinicians to identify high-risk patients relative to specific outcome(s) in real time prior to discharge from hospital or prior to a sentinel event in the community. CFS can be calculated at the bedside, but HFRS calculation can only be done retrospectively when medical records are coded for claims after discharge. This makes HFRS more suited to research or post hoc quality measure work and CFS more suited to clinical use as the authors describe.

Although using a frailty indicator to help determine those at high risk of early readmission is an important objective, the presence of frailty accounts for only part of a person’s risk for readmission or other untoward events. Reasons for readmissions are complex and often heavily weighted on a lack of social and community supports. A deeper understanding of the reasons for readmission is needed to establish whether readmission of these complex patients has more to do with frailty or other drivers such as poor transitions of care.

The prevalence of frailty will continue to increase as our population ages. Definitions of frailty vary, but there is a broad agreement that frailty, regardless of how it is constructed, increases with age, results in multisystem changes, and leads to increased healthcare utilization and costs. Preventing the development of frailty, identifying frailty, and developing interventions to address frailty in and out of the hospital setting are all vital. We welcome further research regarding the biopsychosocial constructs of frailty, how they overlap with the frailty phenotype, and how these constructs inform both our understanding of frailty and the use of frailty tools.

Disclosures

The authors have no conflicts of interest to report.

In this issue of the Journal of Hospital Medicine, McAlister et al.¹ compared the ability of the Clinical Frailty Scale (CFS) and the Hospital Frailty Risk Score (HFRS) to predict 30-day readmission or death. The authors prospectively assessed adult patients aged ≥18 years without cognitive impairment being discharged back to the community after medical admissions. They demonstrated only modest overlap in frailty designation between HFRS and CFS and concluded that CFS is better than HFRS for predicting the outcomes of interest.

Before a prediction rule is widely adopted for use in routine practice, robust external validation is needed.² Factors such as the prevalence of disease in a population, the clinical competencies of a health system, the socioeconomic status, and the ethnicity of the population can all affect how well a clinical rule performs, but may not become apparent until a prospective validation in a different population is attempted.

In developing the HFRS, Gilbert et al. aimed to create a low-cost, highly generalizable method of identifying frailty using International Classification of Diseases (ICD) 10 billing codes.³ The derivation and validation cohorts for HFRS included older adults aged >75 years in the United Kingdom, many of whom had cognitive impairment. Therefore, it is not surprising that the tool behaved very differently in the younger Canadian cohort described by McAlister et al. where persons with cognitive impairment were excluded. That the HFRS had less predictability in the Canadian cohort may simply indicate that it performs better in an older population with cognitive vulnerabilities; given the frailty constructs of the CFS, it may provide less insights in older populations.

We applaud the efforts to find a way to better identify high-risk groups of adults. We also appreciate the increasing attention to function and other frailty-related domains in risk prediction models. Nevertheless, we recommend caution in using any of the many existing frailty indices⁴ in risk prediction tools unless it is clear what domains of frailty are most relevant for the predicted outcome and what population is the subject of interest.

One of the challenges of choosing an appropriate frailty tool is that different tools are measuring different domains or constructs of frailty. Most consider frailty either as a physical phenotype⁵ or as a more multifaceted construct with impairments in physical and mental health, function, and social interaction.⁶ There is often poor overlap between those individuals identified as frail by different measures, highlighting that they are in fact identifying different people within the population studied and have different predictive abilities.

An ideal frailty tool for clinical use would allow clinicians to identify high-risk patients relative to specific outcome(s) in real time prior to discharge from hospital or prior to a sentinel event in the community. CFS can be calculated at the bedside, but HFRS calculation can only be done retrospectively when medical records are coded for claims after discharge. This makes HFRS more suited to research or post hoc quality measure work and CFS more suited to clinical use as the authors describe.

Although using a frailty indicator to help determine those at high risk of early readmission is an important objective, the presence of frailty accounts for only part of a person’s risk for readmission or other untoward events. Reasons for readmissions are complex and often heavily weighted on a lack of social and community supports. A deeper understanding of the reasons for readmission is needed to establish whether readmission of these complex patients has more to do with frailty or other drivers such as poor transitions of care.

The prevalence of frailty will continue to increase as our population ages. Definitions of frailty vary, but there is a broad agreement that frailty, regardless of how it is constructed, increases with age, results in multisystem changes, and leads to increased healthcare utilization and costs. Preventing the development of frailty, identifying frailty, and developing interventions to address frailty in and out of the hospital setting are all vital. We welcome further research regarding the biopsychosocial constructs of frailty, how they overlap with the frailty phenotype, and how these constructs inform both our understanding of frailty and the use of frailty tools.

Disclosures

The authors have no conflicts of interest to report.

SAN ANTONIO – Prescription opioid abuse has continued declining since 2011, but opioids remain far more commonly abused than other prescription drugs, including gabapentin and pregabalin, new research shows.

“Both gabapentin and pregabalin are abused but at rates that are 6-56 times less frequent than for opioid analgesics,” wrote Kofi Asomaning, DSci, of Pfizer, and associates at Pfizer and Denver Health’s Rocky Mountain Poison and Drug Center.

“Gabapentin is generally more frequently abused than pregabalin,” they reported in a research poster at the annual meeting of the College on Problems of Drug Dependence.

The researchers analyzed data from the RADARS System Survey of Non-Medical Use of Prescription Drugs Program (NMURx), the RADARS System Treatment Center Programs Combined, and the American Association of Poison Control Centers National Poison Data System (NPDS).

All those use self-reported data. The first is a confidential, anonymous web-based survey used to estimate population-level prevalence, and the second surveys patients with opioid use disorder entering treatment. The NPDS tracks all cases reported to poison control centers nationally.


Analysis of the NMURx data revealed similar lifetime abuse prevalence rates for gabapentin and pregabalin at 0.4%, several magnitudes lower than the 5.3% rate identified with opioids.

Gabapentin, however, had higher rates of abuse in the past month in the Treatment Center Programs Combined. For the third to fourth quarter of 2017, 0.12 per 100,000 population reportedly abused gabapentin, compared with 0.01 per 100,000 for pregabalin. The rate for past-month abuse of opioids was 0.79 per 100,000.

A similar pattern for the same quarter emerged from the NPDS data: Rate of gabapentin abuse was 0.06 per 100,000, rate for pregabalin was 0.01 per 100,000, and rate for opioids was 0.40 per 100,000.

Both pregabalin and opioids were predominantly ingested, though a very small amount of each was inhaled and a similarly small amount of opioids was injected. Data on exposure route for gabapentin were not provided, though it was used more frequently than pregabalin.

The research was funded by Pfizer. The RADARS system is owned by Denver Health and Hospital Authority under the Colorado state government. RADARS receives some funding from pharmaceutical industry subscriptions. Dr. Asomaning and Diane L. Martire, MD, MPH, are Pfizer employees who have financial interests with Pfizer.

SAN ANTONIO – Prescription opioid abuse has continued declining since 2011, but opioids remain far more commonly abused than other prescription drugs, including gabapentin and pregabalin, new research shows.

“Both gabapentin and pregabalin are abused but at rates that are 6-56 times less frequent than for opioid analgesics,” wrote Kofi Asomaning, DSci, of Pfizer, and associates at Pfizer and Denver Health’s Rocky Mountain Poison and Drug Center.

“Gabapentin is generally more frequently abused than pregabalin,” they reported in a research poster at the annual meeting of the College on Problems of Drug Dependence.

The researchers analyzed data from the RADARS System Survey of Non-Medical Use of Prescription Drugs Program (NMURx), the RADARS System Treatment Center Programs Combined, and the American Association of Poison Control Centers National Poison Data System (NPDS).

All those use self-reported data. The first is a confidential, anonymous web-based survey used to estimate population-level prevalence, and the second surveys patients with opioid use disorder entering treatment. The NPDS tracks all cases reported to poison control centers nationally.


Analysis of the NMURx data revealed similar lifetime abuse prevalence rates for gabapentin and pregabalin at 0.4%, several magnitudes lower than the 5.3% rate identified with opioids.

Gabapentin, however, had higher rates of abuse in the past month in the Treatment Center Programs Combined. For the third to fourth quarter of 2017, 0.12 per 100,000 population reportedly abused gabapentin, compared with 0.01 per 100,000 for pregabalin. The rate for past-month abuse of opioids was 0.79 per 100,000.

A similar pattern for the same quarter emerged from the NPDS data: Rate of gabapentin abuse was 0.06 per 100,000, rate for pregabalin was 0.01 per 100,000, and rate for opioids was 0.40 per 100,000.

Both pregabalin and opioids were predominantly ingested, though a very small amount of each was inhaled and a similarly small amount of opioids was injected. Data on exposure route for gabapentin were not provided, though it was used more frequently than pregabalin.

The research was funded by Pfizer. The RADARS system is owned by Denver Health and Hospital Authority under the Colorado state government. RADARS receives some funding from pharmaceutical industry subscriptions. Dr. Asomaning and Diane L. Martire, MD, MPH, are Pfizer employees who have financial interests with Pfizer.

SAN ANTONIO – Prescription opioid abuse has continued declining since 2011, but opioids remain far more commonly abused than other prescription drugs, including gabapentin and pregabalin, new research shows.

“Both gabapentin and pregabalin are abused but at rates that are 6-56 times less frequent than for opioid analgesics,” wrote Kofi Asomaning, DSci, of Pfizer, and associates at Pfizer and Denver Health’s Rocky Mountain Poison and Drug Center.

“Gabapentin is generally more frequently abused than pregabalin,” they reported in a research poster at the annual meeting of the College on Problems of Drug Dependence.

The researchers analyzed data from the RADARS System Survey of Non-Medical Use of Prescription Drugs Program (NMURx), the RADARS System Treatment Center Programs Combined, and the American Association of Poison Control Centers National Poison Data System (NPDS).

All those use self-reported data. The first is a confidential, anonymous web-based survey used to estimate population-level prevalence, and the second surveys patients with opioid use disorder entering treatment. The NPDS tracks all cases reported to poison control centers nationally.


Analysis of the NMURx data revealed similar lifetime abuse prevalence rates for gabapentin and pregabalin at 0.4%, several magnitudes lower than the 5.3% rate identified with opioids.

Gabapentin, however, had higher rates of abuse in the past month in the Treatment Center Programs Combined. For the third to fourth quarter of 2017, 0.12 per 100,000 population reportedly abused gabapentin, compared with 0.01 per 100,000 for pregabalin. The rate for past-month abuse of opioids was 0.79 per 100,000.

A similar pattern for the same quarter emerged from the NPDS data: Rate of gabapentin abuse was 0.06 per 100,000, rate for pregabalin was 0.01 per 100,000, and rate for opioids was 0.40 per 100,000.

Both pregabalin and opioids were predominantly ingested, though a very small amount of each was inhaled and a similarly small amount of opioids was injected. Data on exposure route for gabapentin were not provided, though it was used more frequently than pregabalin.

The research was funded by Pfizer. The RADARS system is owned by Denver Health and Hospital Authority under the Colorado state government. RADARS receives some funding from pharmaceutical industry subscriptions. Dr. Asomaning and Diane L. Martire, MD, MPH, are Pfizer employees who have financial interests with Pfizer.

Anticoagulant use to prevent ischemic strokes in patients with atrial fibrillation (AF) continues to be one of the most challenging decisions facing patients and their physicians, in large part due to significant patient-to-patient variation in both AF-related stroke risk and anticoagulant-associated hemorrhage risk. Now, add a layer of complexity—.how should one approach anticoagulant use following an adverse event such as an acute upper gastrointestinal (GI) hemorrhage? On the one side, the risk of ischemic stroke, and on the other, the risk of recurrent bleeding, either of which can lead to death or disability. Making this decision requires humility, clinical acumen, shared decision-making, and data.

Data on this subject are sparse.^1,2 Observational studies show that patients who restart anticoagulants after GI hemorrhage experience fewer ischemic strokes. These studies also show that patients who restart anticoagulant therapy are healthier than those who do not—in measurable ways and, importantly, in unmeasurable ways. Thus far, observational studies have not sufficiently dealt with confounding by indication; that is, patients who restart anticoagulants are fundamentally different than patients who do not.

In this issue of the Journal of Hospital Medicine^®, Pappas et al. focus on the optimal timing of resuming oral anticoagulation in patients who have sustained acute upper GI bleeds while receiving oral anticoagulation for AF.³ They use a microsimulation modeling approach to address this question, by creating a synthetic population of patients reflective of age, gender, and comorbidities in a United States population of patients with AF. Using data from epidemiologic studies that describe the risk of rebleeding, hemorrhagic complications, and ischemic stroke as well as the quality of life associated with each of these events, the authors have constructed a decision analytic model to determine the optimal day to restart anticoagulation. This modeling approach mitigates confounding by indication, a limitation of observational studies. They report that the optimal day to restart anticoagulant therapy is in the range of 32-51 days. As one would predict, when using direct-acting anticoagulants and for patients with high stroke risk, the investigators find that restarting therapy earlier is associated with greater benefit. These findings help to untangle a knot of risk and benefits facing patients with AF following an acute GI hemorrhage.

Interpreting the results relies on an understanding of the strengths and weaknesses of simulation modeling and the data used in the analysis. Like any research method, the devil is in the details. Stitching together event rates and outcomes from multiple studies, the results of a simulation model are only as good as the studies the model draws from. In particular, assumptions regarding the time-dependent decline in rebleeding risk are a critical component of determining the optimal time to resume anticoagulation. The authors had to make multiple assumptions to project the 24-hour risk of rebleeding determined from the Rockall score to estimate the risk of rebleeding over the next days to months.⁴ Consequently, the results are likely overly precise. Practically, 30-50 days or four to eight weeks may better reflect the precision of the study findings.

Results on optimal timing of resuming anticoagulation therapy are most applicable for patients when the decision to restart anticoagulants has already been made. We part ways with the authors in their conclusion that these results confirm that anticoagulants should be restarted. There are multiple appropriate reasons why anticoagulant therapy should not be restarted following an acute upper GI hemorrhage. For example, in observational studies, patients not restarted on anticoagulant therapy were more likely to have a history of falls and to have had severe bleeds.¹ Furthermore, patients who do not restart therapy are more likely to die in follow-up. It is tempting to use this fact to support restarting anticoagulants. However, when the causes of death are examined, the vast majority of deaths were unrelated to thrombosis or hemorrhage.² Patients with AF are older and have multiple comorbidities and life-limiting conditions. Accordingly, the results of this study are better used to engage patients in shared decision-making and contextualized in the broader picture of patients’ health and goals.⁵

Restarting anticoagulants after a GI hemorrhage is a difficult and high-stakes clinical decision. The study by Pappas et al. uses a simulation model to advance our understanding about the optimal timing to restart anticoagulants. By integrating the dynamic risk of ischemic stroke and recurrent hemorrhage following GI hemorrhage, they estimate the maximal benefit when anticoagulants are restarted between 30 days and 50 days after hemorrhage. The results of their analysis are best used to inform timing among patients where the decision to restart anticoagulants has already been made. The analysis also provides a useful starting point for shared decision-making by highlighting that the optimal net benefit is influenced by patient-to-patient variation in the underlying AF-related stroke risk and anticoagulant-associated rebleeding risk.

Disclosures: Dr. Shah has nothing to disclose. Dr. Eckman reports grants from Heart Rhythm Society/Boehringer-Ingelheim and grants from Bristol-Myers Squibb/Pfizer Education Consortium, outside the submitted work.

Anticoagulant use to prevent ischemic strokes in patients with atrial fibrillation (AF) continues to be one of the most challenging decisions facing patients and their physicians, in large part due to significant patient-to-patient variation in both AF-related stroke risk and anticoagulant-associated hemorrhage risk. Now, add a layer of complexity—.how should one approach anticoagulant use following an adverse event such as an acute upper gastrointestinal (GI) hemorrhage? On the one side, the risk of ischemic stroke, and on the other, the risk of recurrent bleeding, either of which can lead to death or disability. Making this decision requires humility, clinical acumen, shared decision-making, and data.

Data on this subject are sparse.^1,2 Observational studies show that patients who restart anticoagulants after GI hemorrhage experience fewer ischemic strokes. These studies also show that patients who restart anticoagulant therapy are healthier than those who do not—in measurable ways and, importantly, in unmeasurable ways. Thus far, observational studies have not sufficiently dealt with confounding by indication; that is, patients who restart anticoagulants are fundamentally different than patients who do not.

In this issue of the Journal of Hospital Medicine^®, Pappas et al. focus on the optimal timing of resuming oral anticoagulation in patients who have sustained acute upper GI bleeds while receiving oral anticoagulation for AF.³ They use a microsimulation modeling approach to address this question, by creating a synthetic population of patients reflective of age, gender, and comorbidities in a United States population of patients with AF. Using data from epidemiologic studies that describe the risk of rebleeding, hemorrhagic complications, and ischemic stroke as well as the quality of life associated with each of these events, the authors have constructed a decision analytic model to determine the optimal day to restart anticoagulation. This modeling approach mitigates confounding by indication, a limitation of observational studies. They report that the optimal day to restart anticoagulant therapy is in the range of 32-51 days. As one would predict, when using direct-acting anticoagulants and for patients with high stroke risk, the investigators find that restarting therapy earlier is associated with greater benefit. These findings help to untangle a knot of risk and benefits facing patients with AF following an acute GI hemorrhage.

Interpreting the results relies on an understanding of the strengths and weaknesses of simulation modeling and the data used in the analysis. Like any research method, the devil is in the details. Stitching together event rates and outcomes from multiple studies, the results of a simulation model are only as good as the studies the model draws from. In particular, assumptions regarding the time-dependent decline in rebleeding risk are a critical component of determining the optimal time to resume anticoagulation. The authors had to make multiple assumptions to project the 24-hour risk of rebleeding determined from the Rockall score to estimate the risk of rebleeding over the next days to months.⁴ Consequently, the results are likely overly precise. Practically, 30-50 days or four to eight weeks may better reflect the precision of the study findings.

Results on optimal timing of resuming anticoagulation therapy are most applicable for patients when the decision to restart anticoagulants has already been made. We part ways with the authors in their conclusion that these results confirm that anticoagulants should be restarted. There are multiple appropriate reasons why anticoagulant therapy should not be restarted following an acute upper GI hemorrhage. For example, in observational studies, patients not restarted on anticoagulant therapy were more likely to have a history of falls and to have had severe bleeds.¹ Furthermore, patients who do not restart therapy are more likely to die in follow-up. It is tempting to use this fact to support restarting anticoagulants. However, when the causes of death are examined, the vast majority of deaths were unrelated to thrombosis or hemorrhage.² Patients with AF are older and have multiple comorbidities and life-limiting conditions. Accordingly, the results of this study are better used to engage patients in shared decision-making and contextualized in the broader picture of patients’ health and goals.⁵

Restarting anticoagulants after a GI hemorrhage is a difficult and high-stakes clinical decision. The study by Pappas et al. uses a simulation model to advance our understanding about the optimal timing to restart anticoagulants. By integrating the dynamic risk of ischemic stroke and recurrent hemorrhage following GI hemorrhage, they estimate the maximal benefit when anticoagulants are restarted between 30 days and 50 days after hemorrhage. The results of their analysis are best used to inform timing among patients where the decision to restart anticoagulants has already been made. The analysis also provides a useful starting point for shared decision-making by highlighting that the optimal net benefit is influenced by patient-to-patient variation in the underlying AF-related stroke risk and anticoagulant-associated rebleeding risk.

Disclosures: Dr. Shah has nothing to disclose. Dr. Eckman reports grants from Heart Rhythm Society/Boehringer-Ingelheim and grants from Bristol-Myers Squibb/Pfizer Education Consortium, outside the submitted work.

Anticoagulant use to prevent ischemic strokes in patients with atrial fibrillation (AF) continues to be one of the most challenging decisions facing patients and their physicians, in large part due to significant patient-to-patient variation in both AF-related stroke risk and anticoagulant-associated hemorrhage risk. Now, add a layer of complexity—.how should one approach anticoagulant use following an adverse event such as an acute upper gastrointestinal (GI) hemorrhage? On the one side, the risk of ischemic stroke, and on the other, the risk of recurrent bleeding, either of which can lead to death or disability. Making this decision requires humility, clinical acumen, shared decision-making, and data.

Data on this subject are sparse.^1,2 Observational studies show that patients who restart anticoagulants after GI hemorrhage experience fewer ischemic strokes. These studies also show that patients who restart anticoagulant therapy are healthier than those who do not—in measurable ways and, importantly, in unmeasurable ways. Thus far, observational studies have not sufficiently dealt with confounding by indication; that is, patients who restart anticoagulants are fundamentally different than patients who do not.

In this issue of the Journal of Hospital Medicine^®, Pappas et al. focus on the optimal timing of resuming oral anticoagulation in patients who have sustained acute upper GI bleeds while receiving oral anticoagulation for AF.³ They use a microsimulation modeling approach to address this question, by creating a synthetic population of patients reflective of age, gender, and comorbidities in a United States population of patients with AF. Using data from epidemiologic studies that describe the risk of rebleeding, hemorrhagic complications, and ischemic stroke as well as the quality of life associated with each of these events, the authors have constructed a decision analytic model to determine the optimal day to restart anticoagulation. This modeling approach mitigates confounding by indication, a limitation of observational studies. They report that the optimal day to restart anticoagulant therapy is in the range of 32-51 days. As one would predict, when using direct-acting anticoagulants and for patients with high stroke risk, the investigators find that restarting therapy earlier is associated with greater benefit. These findings help to untangle a knot of risk and benefits facing patients with AF following an acute GI hemorrhage.

Interpreting the results relies on an understanding of the strengths and weaknesses of simulation modeling and the data used in the analysis. Like any research method, the devil is in the details. Stitching together event rates and outcomes from multiple studies, the results of a simulation model are only as good as the studies the model draws from. In particular, assumptions regarding the time-dependent decline in rebleeding risk are a critical component of determining the optimal time to resume anticoagulation. The authors had to make multiple assumptions to project the 24-hour risk of rebleeding determined from the Rockall score to estimate the risk of rebleeding over the next days to months.⁴ Consequently, the results are likely overly precise. Practically, 30-50 days or four to eight weeks may better reflect the precision of the study findings.

Results on optimal timing of resuming anticoagulation therapy are most applicable for patients when the decision to restart anticoagulants has already been made. We part ways with the authors in their conclusion that these results confirm that anticoagulants should be restarted. There are multiple appropriate reasons why anticoagulant therapy should not be restarted following an acute upper GI hemorrhage. For example, in observational studies, patients not restarted on anticoagulant therapy were more likely to have a history of falls and to have had severe bleeds.¹ Furthermore, patients who do not restart therapy are more likely to die in follow-up. It is tempting to use this fact to support restarting anticoagulants. However, when the causes of death are examined, the vast majority of deaths were unrelated to thrombosis or hemorrhage.² Patients with AF are older and have multiple comorbidities and life-limiting conditions. Accordingly, the results of this study are better used to engage patients in shared decision-making and contextualized in the broader picture of patients’ health and goals.⁵

Restarting anticoagulants after a GI hemorrhage is a difficult and high-stakes clinical decision. The study by Pappas et al. uses a simulation model to advance our understanding about the optimal timing to restart anticoagulants. By integrating the dynamic risk of ischemic stroke and recurrent hemorrhage following GI hemorrhage, they estimate the maximal benefit when anticoagulants are restarted between 30 days and 50 days after hemorrhage. The results of their analysis are best used to inform timing among patients where the decision to restart anticoagulants has already been made. The analysis also provides a useful starting point for shared decision-making by highlighting that the optimal net benefit is influenced by patient-to-patient variation in the underlying AF-related stroke risk and anticoagulant-associated rebleeding risk.

Disclosures: Dr. Shah has nothing to disclose. Dr. Eckman reports grants from Heart Rhythm Society/Boehringer-Ingelheim and grants from Bristol-Myers Squibb/Pfizer Education Consortium, outside the submitted work.

MADRID – The first consensus recommendations for the identification and management of interstitial lung disease (ILD) in patients with systemic sclerosis (SSc) place particular emphasis on routine screening in all systemic sclerosis patients for early detection, monitoring, and, when warranted, treatment, Anna-Maria Hoffmann-Vold, MD, PhD, reported at the European Congress of Rheumatology.

“Everyone with systemic sclerosis needs to be screened because this is the most important risk factor for ILD,” said Dr. Hoffmann-Vold, a clinical scientist in the division of rheumatology at the University of Oslo and head of scleroderma research at Oslo University Hospital.

Although the frequency of screening is not specified based on the opinion that this should be based on risk factors and other clinical characteristics, there was unanimous agreement that lung function tests do not represent an adequate screening tool or method for assessing ILD severity. Rather, the recommendations make clear that lung function studies are adjunctive to high-resolution computed tomography (HRCT).

“HRCT is the primary tool for evaluating ILD, but there was 100% agreement that assessment should include more than one measure, including lung function tests and clinical assessment,” Dr. Hoffmann-Vold reported.

There was a strong opinion that the numerous potential biomarkers described for ILD, although promising, are not yet ready for clinical use.

In developing these new recommendations, 95 potential statements were considered by the panel of 27 rheumatologists, pulmonologists, and others with experience in this field. A Delphi process was used for members of the panel to identify areas of agreement to produce consensus statements.

The result has been more than 50 statements issued in six major domains. These include statements on risk factors, appropriate methodology for diagnosis and severity assessment, when to initiate therapy, and when and how to initiate treatment escalation.

“We want to increase clinician awareness and provide standardized guidance for evaluating patients for the presence and medical management of ILD-SSc,” Dr. Hoffmann-Vold explained.

ILD occurs in about half of all patients with systemic sclerosis. Among these, approximately one out of three will experience lung disease progression. Although these high prevalence rates are well recognized and associated with high morbidity and mortality, Dr. Hoffmann-Vold said that there has been uncertainty about how to screen systemic sclerosis patients for ILD and what steps to take when it was found. It is this uncertainty that prompted the present initiative.

The consensus recommendations are an initial step to guide clinicians, but Dr. Hoffmann-Vold noted that the many statements are based on expert opinion, suggesting more studies are needed to compare strategies for objective severity grading and prediction of which patients are most at risk for ILD progression.

“There are still huge knowledge gaps we need to fill,” she stated. Still, she believes these recommendations represent progress in this field. While they are likely “to increase the standard of care” for those who develop ILD-SSc, they also have identified where to concentrate further research.

Dr. Hoffmann-Vold reported financial relationships with Actelion, Boehringer Ingelheim, and GlaxoSmithKline.

SOURCE: Hoffmann-Vold A-M et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):104, Abstract OPO064, doi: 10.1136/annrheumdis-2019-eular.3225.

MADRID – The first consensus recommendations for the identification and management of interstitial lung disease (ILD) in patients with systemic sclerosis (SSc) place particular emphasis on routine screening in all systemic sclerosis patients for early detection, monitoring, and, when warranted, treatment, Anna-Maria Hoffmann-Vold, MD, PhD, reported at the European Congress of Rheumatology.

“Everyone with systemic sclerosis needs to be screened because this is the most important risk factor for ILD,” said Dr. Hoffmann-Vold, a clinical scientist in the division of rheumatology at the University of Oslo and head of scleroderma research at Oslo University Hospital.

Although the frequency of screening is not specified based on the opinion that this should be based on risk factors and other clinical characteristics, there was unanimous agreement that lung function tests do not represent an adequate screening tool or method for assessing ILD severity. Rather, the recommendations make clear that lung function studies are adjunctive to high-resolution computed tomography (HRCT).

“HRCT is the primary tool for evaluating ILD, but there was 100% agreement that assessment should include more than one measure, including lung function tests and clinical assessment,” Dr. Hoffmann-Vold reported.

There was a strong opinion that the numerous potential biomarkers described for ILD, although promising, are not yet ready for clinical use.

In developing these new recommendations, 95 potential statements were considered by the panel of 27 rheumatologists, pulmonologists, and others with experience in this field. A Delphi process was used for members of the panel to identify areas of agreement to produce consensus statements.

The result has been more than 50 statements issued in six major domains. These include statements on risk factors, appropriate methodology for diagnosis and severity assessment, when to initiate therapy, and when and how to initiate treatment escalation.

“We want to increase clinician awareness and provide standardized guidance for evaluating patients for the presence and medical management of ILD-SSc,” Dr. Hoffmann-Vold explained.

ILD occurs in about half of all patients with systemic sclerosis. Among these, approximately one out of three will experience lung disease progression. Although these high prevalence rates are well recognized and associated with high morbidity and mortality, Dr. Hoffmann-Vold said that there has been uncertainty about how to screen systemic sclerosis patients for ILD and what steps to take when it was found. It is this uncertainty that prompted the present initiative.

The consensus recommendations are an initial step to guide clinicians, but Dr. Hoffmann-Vold noted that the many statements are based on expert opinion, suggesting more studies are needed to compare strategies for objective severity grading and prediction of which patients are most at risk for ILD progression.

“There are still huge knowledge gaps we need to fill,” she stated. Still, she believes these recommendations represent progress in this field. While they are likely “to increase the standard of care” for those who develop ILD-SSc, they also have identified where to concentrate further research.

Dr. Hoffmann-Vold reported financial relationships with Actelion, Boehringer Ingelheim, and GlaxoSmithKline.

SOURCE: Hoffmann-Vold A-M et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):104, Abstract OPO064, doi: 10.1136/annrheumdis-2019-eular.3225.

MADRID – The first consensus recommendations for the identification and management of interstitial lung disease (ILD) in patients with systemic sclerosis (SSc) place particular emphasis on routine screening in all systemic sclerosis patients for early detection, monitoring, and, when warranted, treatment, Anna-Maria Hoffmann-Vold, MD, PhD, reported at the European Congress of Rheumatology.

“Everyone with systemic sclerosis needs to be screened because this is the most important risk factor for ILD,” said Dr. Hoffmann-Vold, a clinical scientist in the division of rheumatology at the University of Oslo and head of scleroderma research at Oslo University Hospital.

Although the frequency of screening is not specified based on the opinion that this should be based on risk factors and other clinical characteristics, there was unanimous agreement that lung function tests do not represent an adequate screening tool or method for assessing ILD severity. Rather, the recommendations make clear that lung function studies are adjunctive to high-resolution computed tomography (HRCT).

“HRCT is the primary tool for evaluating ILD, but there was 100% agreement that assessment should include more than one measure, including lung function tests and clinical assessment,” Dr. Hoffmann-Vold reported.

There was a strong opinion that the numerous potential biomarkers described for ILD, although promising, are not yet ready for clinical use.

In developing these new recommendations, 95 potential statements were considered by the panel of 27 rheumatologists, pulmonologists, and others with experience in this field. A Delphi process was used for members of the panel to identify areas of agreement to produce consensus statements.

The result has been more than 50 statements issued in six major domains. These include statements on risk factors, appropriate methodology for diagnosis and severity assessment, when to initiate therapy, and when and how to initiate treatment escalation.

“We want to increase clinician awareness and provide standardized guidance for evaluating patients for the presence and medical management of ILD-SSc,” Dr. Hoffmann-Vold explained.

ILD occurs in about half of all patients with systemic sclerosis. Among these, approximately one out of three will experience lung disease progression. Although these high prevalence rates are well recognized and associated with high morbidity and mortality, Dr. Hoffmann-Vold said that there has been uncertainty about how to screen systemic sclerosis patients for ILD and what steps to take when it was found. It is this uncertainty that prompted the present initiative.

The consensus recommendations are an initial step to guide clinicians, but Dr. Hoffmann-Vold noted that the many statements are based on expert opinion, suggesting more studies are needed to compare strategies for objective severity grading and prediction of which patients are most at risk for ILD progression.

“There are still huge knowledge gaps we need to fill,” she stated. Still, she believes these recommendations represent progress in this field. While they are likely “to increase the standard of care” for those who develop ILD-SSc, they also have identified where to concentrate further research.

Dr. Hoffmann-Vold reported financial relationships with Actelion, Boehringer Ingelheim, and GlaxoSmithKline.

SOURCE: Hoffmann-Vold A-M et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):104, Abstract OPO064, doi: 10.1136/annrheumdis-2019-eular.3225.

CHICAGO – Tumor protein 53 (TP53) mutation, fibroblast growth factor receptor 1 (FGFR1) amplification, and tumor purity in plasma each predict early progression on palbociclib and/or fulvestrant in patients with advanced estrogen receptor–positive (ER+) breast cancer, according to genomic analyses of PALOMA-3 trial data.

Sharon Worcester/MDedge News

Overall, the presence of one or more of these genomic changes identified 131 out of 310 patients from the phase 3 trial who had baseline samples available, Ben O’Leary, MBBS, said at the annual meeting of the American Society of Clinical Oncology.

“So, a significant minority of patients – 42.3% – potentially who fall into a more poor-prognosis group,” said Dr. O’Leary of the Institute of Cancer Research at the Royal Marsden Hospital in London.

The findings suggest that a “liquid biopsy” at the start of treatment could identify patients at risk for progression.

The PALOMA-3 trial randomized 521 patients with ER+, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who had previously progressed on endocrine therapy 2:1 to CDK4/CDK6 inhibition with palbociclib plus fulvestrant (P+F) or placebo plus fulvestrant (F), and it showed that adding palbociclib significantly improved progression-free survival (PFS) (N Engl J Med. Jul 16 2015;373:209-19).

For the current analysis, the investigators assessed circulating tumor DNA (ctDNA) in baseline plasma samples from 459 study participants in an effort to identify genomic biomarkers for progression, to examine the association between baseline tumor fraction and clinical outcome, and to explore differences in predictive markers by treatment arm. A custom amplicon-sequencing analysis was performed to look for mutations in 17 different relevant genes, and another was used to estimate tumor fraction by looking at about 800 common germline single-nucleotide polymorphisms and to assess copy-number gain in the amplification status in 11 different genes, Dr. O’Leary said.


Results for mutations and circulating nucleic acids were available in 203 and 107 patients from the P+F and F groups, respectively, and on multivariable analysis of all 310 patients (including palbociclib as a variable in the model and with ctDNA fraction as a continuous variable), higher baseline tumor purity in plasma was associated with highly significantly worse PFS (HR 1.2 per 10% increase in purity), and baseline TP53 mutation and FGFR1 amplification each were associated with significantly shorter PFS (HRs, 1.8 and 2.9, respectively).

“[It is] very important to note ... that we did look specifically for interaction between our genomic changes and treatment, and we didn’t find any evidence of a significant interaction, so these genomic markers [are] prognostic rather than predictive in terms of the two treatment arms of the trial,” he said.

A survival analysis showed a median PFS of 3.7 vs. 12.7 months in patients with vs. without TP53 mutation in the P+F arm, and 1.8 vs. 5.4 months, respectively, in the F arm, with similar HRs of 2.0 and 2.3 in the arms, respectively.

“Even in the [P+F] arm, you see almost half of the patients with a TP53 mutation ... have relapsed by 2 months, the earliest clinical assessment in the trial,” he noted.

For FGFR1, the PFS was 3.9 vs. 12 months with vs. without amplification in the P+F arms, and 1.8 vs. 5.8 months, respectively in th F arm, with HRs of 3.4 and 3.6, respectively.

These findings are notable because markers of early progression on endocrine therapy in combination with CDK4/6 inhibitors remain limited – despite the key role of these combinations in treating ER+ advanced breast cancer, Dr. O’Leary explained.

“Although many patients derive a great deal of benefit from these combinations, there are a subset of patients who will relapse relatively early, and ... we don’t have an established means of identifying those patients at the present,” he said. “From the technical perspective, liquid biopsies have emerged in recent years as a promising means of genotyping patients’ cancers from circulating tumor DNA, and in addition, the overall level of circulating tumor DNA – the fractional purity – has been associated with poor prognosis, specifically in the triple-negative breast cancer setting.”

The results, which require independent validation, could potentially inform future clinical trials of CDK4/6 inhibitor combinations in advanced ER+ breast cancer to identify a high-risk group of patients who require escalation of therapy, he concluded.

Dr. O’Leary reported receiving research funding from Pfizer to his institution.

SOURCE: O’Leary B et al. ASCO 2019, Abstract 1010.

CHICAGO – Tumor protein 53 (TP53) mutation, fibroblast growth factor receptor 1 (FGFR1) amplification, and tumor purity in plasma each predict early progression on palbociclib and/or fulvestrant in patients with advanced estrogen receptor–positive (ER+) breast cancer, according to genomic analyses of PALOMA-3 trial data.

Sharon Worcester/MDedge News

Overall, the presence of one or more of these genomic changes identified 131 out of 310 patients from the phase 3 trial who had baseline samples available, Ben O’Leary, MBBS, said at the annual meeting of the American Society of Clinical Oncology.

“So, a significant minority of patients – 42.3% – potentially who fall into a more poor-prognosis group,” said Dr. O’Leary of the Institute of Cancer Research at the Royal Marsden Hospital in London.

The findings suggest that a “liquid biopsy” at the start of treatment could identify patients at risk for progression.

The PALOMA-3 trial randomized 521 patients with ER+, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who had previously progressed on endocrine therapy 2:1 to CDK4/CDK6 inhibition with palbociclib plus fulvestrant (P+F) or placebo plus fulvestrant (F), and it showed that adding palbociclib significantly improved progression-free survival (PFS) (N Engl J Med. Jul 16 2015;373:209-19).

For the current analysis, the investigators assessed circulating tumor DNA (ctDNA) in baseline plasma samples from 459 study participants in an effort to identify genomic biomarkers for progression, to examine the association between baseline tumor fraction and clinical outcome, and to explore differences in predictive markers by treatment arm. A custom amplicon-sequencing analysis was performed to look for mutations in 17 different relevant genes, and another was used to estimate tumor fraction by looking at about 800 common germline single-nucleotide polymorphisms and to assess copy-number gain in the amplification status in 11 different genes, Dr. O’Leary said.


Results for mutations and circulating nucleic acids were available in 203 and 107 patients from the P+F and F groups, respectively, and on multivariable analysis of all 310 patients (including palbociclib as a variable in the model and with ctDNA fraction as a continuous variable), higher baseline tumor purity in plasma was associated with highly significantly worse PFS (HR 1.2 per 10% increase in purity), and baseline TP53 mutation and FGFR1 amplification each were associated with significantly shorter PFS (HRs, 1.8 and 2.9, respectively).

“[It is] very important to note ... that we did look specifically for interaction between our genomic changes and treatment, and we didn’t find any evidence of a significant interaction, so these genomic markers [are] prognostic rather than predictive in terms of the two treatment arms of the trial,” he said.

A survival analysis showed a median PFS of 3.7 vs. 12.7 months in patients with vs. without TP53 mutation in the P+F arm, and 1.8 vs. 5.4 months, respectively, in the F arm, with similar HRs of 2.0 and 2.3 in the arms, respectively.

“Even in the [P+F] arm, you see almost half of the patients with a TP53 mutation ... have relapsed by 2 months, the earliest clinical assessment in the trial,” he noted.

For FGFR1, the PFS was 3.9 vs. 12 months with vs. without amplification in the P+F arms, and 1.8 vs. 5.8 months, respectively in th F arm, with HRs of 3.4 and 3.6, respectively.

These findings are notable because markers of early progression on endocrine therapy in combination with CDK4/6 inhibitors remain limited – despite the key role of these combinations in treating ER+ advanced breast cancer, Dr. O’Leary explained.

“Although many patients derive a great deal of benefit from these combinations, there are a subset of patients who will relapse relatively early, and ... we don’t have an established means of identifying those patients at the present,” he said. “From the technical perspective, liquid biopsies have emerged in recent years as a promising means of genotyping patients’ cancers from circulating tumor DNA, and in addition, the overall level of circulating tumor DNA – the fractional purity – has been associated with poor prognosis, specifically in the triple-negative breast cancer setting.”

The results, which require independent validation, could potentially inform future clinical trials of CDK4/6 inhibitor combinations in advanced ER+ breast cancer to identify a high-risk group of patients who require escalation of therapy, he concluded.

Dr. O’Leary reported receiving research funding from Pfizer to his institution.

SOURCE: O’Leary B et al. ASCO 2019, Abstract 1010.

CHICAGO – Tumor protein 53 (TP53) mutation, fibroblast growth factor receptor 1 (FGFR1) amplification, and tumor purity in plasma each predict early progression on palbociclib and/or fulvestrant in patients with advanced estrogen receptor–positive (ER+) breast cancer, according to genomic analyses of PALOMA-3 trial data.

Sharon Worcester/MDedge News

Overall, the presence of one or more of these genomic changes identified 131 out of 310 patients from the phase 3 trial who had baseline samples available, Ben O’Leary, MBBS, said at the annual meeting of the American Society of Clinical Oncology.

“So, a significant minority of patients – 42.3% – potentially who fall into a more poor-prognosis group,” said Dr. O’Leary of the Institute of Cancer Research at the Royal Marsden Hospital in London.

The findings suggest that a “liquid biopsy” at the start of treatment could identify patients at risk for progression.

The PALOMA-3 trial randomized 521 patients with ER+, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who had previously progressed on endocrine therapy 2:1 to CDK4/CDK6 inhibition with palbociclib plus fulvestrant (P+F) or placebo plus fulvestrant (F), and it showed that adding palbociclib significantly improved progression-free survival (PFS) (N Engl J Med. Jul 16 2015;373:209-19).

For the current analysis, the investigators assessed circulating tumor DNA (ctDNA) in baseline plasma samples from 459 study participants in an effort to identify genomic biomarkers for progression, to examine the association between baseline tumor fraction and clinical outcome, and to explore differences in predictive markers by treatment arm. A custom amplicon-sequencing analysis was performed to look for mutations in 17 different relevant genes, and another was used to estimate tumor fraction by looking at about 800 common germline single-nucleotide polymorphisms and to assess copy-number gain in the amplification status in 11 different genes, Dr. O’Leary said.


Results for mutations and circulating nucleic acids were available in 203 and 107 patients from the P+F and F groups, respectively, and on multivariable analysis of all 310 patients (including palbociclib as a variable in the model and with ctDNA fraction as a continuous variable), higher baseline tumor purity in plasma was associated with highly significantly worse PFS (HR 1.2 per 10% increase in purity), and baseline TP53 mutation and FGFR1 amplification each were associated with significantly shorter PFS (HRs, 1.8 and 2.9, respectively).

“[It is] very important to note ... that we did look specifically for interaction between our genomic changes and treatment, and we didn’t find any evidence of a significant interaction, so these genomic markers [are] prognostic rather than predictive in terms of the two treatment arms of the trial,” he said.

A survival analysis showed a median PFS of 3.7 vs. 12.7 months in patients with vs. without TP53 mutation in the P+F arm, and 1.8 vs. 5.4 months, respectively, in the F arm, with similar HRs of 2.0 and 2.3 in the arms, respectively.

“Even in the [P+F] arm, you see almost half of the patients with a TP53 mutation ... have relapsed by 2 months, the earliest clinical assessment in the trial,” he noted.

For FGFR1, the PFS was 3.9 vs. 12 months with vs. without amplification in the P+F arms, and 1.8 vs. 5.8 months, respectively in th F arm, with HRs of 3.4 and 3.6, respectively.

These findings are notable because markers of early progression on endocrine therapy in combination with CDK4/6 inhibitors remain limited – despite the key role of these combinations in treating ER+ advanced breast cancer, Dr. O’Leary explained.

“Although many patients derive a great deal of benefit from these combinations, there are a subset of patients who will relapse relatively early, and ... we don’t have an established means of identifying those patients at the present,” he said. “From the technical perspective, liquid biopsies have emerged in recent years as a promising means of genotyping patients’ cancers from circulating tumor DNA, and in addition, the overall level of circulating tumor DNA – the fractional purity – has been associated with poor prognosis, specifically in the triple-negative breast cancer setting.”

The results, which require independent validation, could potentially inform future clinical trials of CDK4/6 inhibitor combinations in advanced ER+ breast cancer to identify a high-risk group of patients who require escalation of therapy, he concluded.

Dr. O’Leary reported receiving research funding from Pfizer to his institution.

SOURCE: O’Leary B et al. ASCO 2019, Abstract 1010.

The inability to be in two places at one time makes VAM On Demand an essential component of the Vascular Annual Meeting.

ISerg Creative/Getty Images

VAM on Demand lets people review — in depth and on their own timeline —sessions they attended and “attend” electronically the ones they couldn’t in person. VAM on Demand will include hundreds of individual presentations, with accompanying PowerPoint slides and audio. Select video sessions will be available.

The fee is $199 for attendees after the meeting ends. (Non-attendees may purchase VAM on Demand for $499.) All purchasers receive unlimited access, plus downloads to the library, for up to one year. Access begins several weeks after VAM ends and will be available on the SVS website vascular.org.

Contact [email protected] with questions.




 

The inability to be in two places at one time makes VAM On Demand an essential component of the Vascular Annual Meeting.

ISerg Creative/Getty Images

VAM on Demand lets people review — in depth and on their own timeline —sessions they attended and “attend” electronically the ones they couldn’t in person. VAM on Demand will include hundreds of individual presentations, with accompanying PowerPoint slides and audio. Select video sessions will be available.

The fee is $199 for attendees after the meeting ends. (Non-attendees may purchase VAM on Demand for $499.) All purchasers receive unlimited access, plus downloads to the library, for up to one year. Access begins several weeks after VAM ends and will be available on the SVS website vascular.org.

Contact [email protected] with questions.




 

The inability to be in two places at one time makes VAM On Demand an essential component of the Vascular Annual Meeting.

ISerg Creative/Getty Images

VAM on Demand lets people review — in depth and on their own timeline —sessions they attended and “attend” electronically the ones they couldn’t in person. VAM on Demand will include hundreds of individual presentations, with accompanying PowerPoint slides and audio. Select video sessions will be available.

The fee is $199 for attendees after the meeting ends. (Non-attendees may purchase VAM on Demand for $499.) All purchasers receive unlimited access, plus downloads to the library, for up to one year. Access begins several weeks after VAM ends and will be available on the SVS website vascular.org.

Contact [email protected] with questions.




 

During my medical training and fellowship, I often heard that my education was not preparing me for the real world. After 3 years of internal medicine training with limited exposure to the outpatient arena and 3-4 years of specialty gastroenterology, hepatology, and advanced procedure training, you’ve probably heard the same thing. If you’ve chosen private practice, the thought of building a practice and establishing referrals probably seems daunting. It doesn’t have to be. Most gastroenterologists who enter private practice have felt this way early on, and our experiences can help you navigate some of the major factors that influence clinical practice to build a thriving career in gastroenterology.

Conduct research on referrals

Once you’ve decided to join a practice, do some research about local dynamics between large hospital systems and private practice. Community clinical practice is unique and varies by region, location, and how the practice is set up. GIs working in rural, low-access areas face different challenges than those working in urban areas near major health care systems. In rural, low-access areas, some physicians have long wait lists for office appointments and procedures.

In urban settings, there may be a larger population of patients but more competition from hospital systems and other practices. In this case, you’ll have to figure out where most of the referrals come from and why – is it the group’s overall reputation or are there physicians in the practice with a highly needed specialty?

Determine if your specialty training can be a differentiator in your market. If you are multilingual and there is a large patient population that speaks the language(s) in which you are fluent, this can be a great way to bring new patients into a practice. This is especially true if there aren’t many (or any) physicians in the practice who are multilingual.

Meet with local physicians in health care systems. Make a connection with hospitalists, referring physicians, ED physicians, advanced practitioners, and surgeons while covering inpatient service. Volunteer for teaching activities – including for nursing staff, who are a great referral source.

Figure out what opportunities exist to have direct interactions with patients, such as health fairs. If possible, it might be smart to invest in marketing directly to patients in your community as well. Leverage opportunities provided by awareness months – such as providing patients with information about cancer screening – to establish a referral basis.

Medical practice is complex and at times can be confusing until you’ve practiced in a given location for some time. Look internally to learn about the community. It’s always a good idea to learn from those who have been practicing in the community for a long time. Don’t hesitate to ask questions and make suggestions, even if they seem naive. Develop relationships with staff members and gain their trust. Establishing a clear understanding of your specialty with your colleagues and staff also can be a good way to find referrals.

Learn the internal process

Schedules during early months are usually filled with urgent patients. Make yourself available for overflow referrals to other established physicians within the practice and for hospital discharge follow-ups. Reading through the charts of these patients can help you understand the various styles of other doctors and can help you familiarize yourself with referring physicians.

This also will help to clarify the process of how a patient moves through the system – from the time patients call the office to when they check out. This includes navigating through procedures, results reporting, and the recall system. While it will be hard to master all aspects of a practice right away, processes within practices are well established, and it is important for you to have a good understanding of how they function.

Focus on patient care and satisfaction

Learning internal processes also can be useful in increasing patient satisfaction, an important quality outcome indicator. As you’re starting out, keep the following things in mind that can help put your patients at ease and increase satisfaction.

• Understand how to communicate what a patient should expect when being seen. Being at ease with the process helps garner trust and confidence.
• Call patients the next day to check on their symptoms.
• Relay results personally. Make connections with family member(s).
• Remember that cultural competency is important. Do everything you can to ensure you’re meeting the social, cultural, and linguistic needs of patients in your community.
• Above all – continue to provide personalized and thorough care. Word of mouth is the best form of referral and is time tested.

Continue to grow

As you begin to understand the dynamics of local practice, it’s important to establish where you fit into the practice and start differentiating your expertise. Here are some ideas and suggestions for how you can continue to expand your patient base.

• Differentiate and establish a subspecialty within your practice: Motility, inflammatory bowel disease, Clostridium difficile/fecal microbiota transplantation, liver diseases, Celiac disease, and medical weight-loss programs are just a few.
• Establish connections with local medical societies as well as hospital and state committees. This is a great way to connect with other physicians of various specialties. If you have a specialty unique to the area, it may help establish a clear referral line.
• Establish a consistent conversation with referring physicians – get to know them and keep direct lines of communication, such as having their cell phone numbers.
• Look for public speaking engagements that reach patients directly. These are organized mostly through patient-based organization and foundations.
• Increase your reach through the local media and through social media platforms like Facebook, Instagram, and Twitter.

At this point, you should have plenty of patients to keep you busy, which could lead to other challenges in managing your various responsibilities and obligations. A key factor at this stage to help reduce stress is to lean on the effective and efficient support system your practice should have in place. Educating medical assistants or nurses on the most common GI diseases and conditions can help reduce the time involved in communicating results. Practice management software and patient portals can help create efficiencies to handle the increasing number of patient visits.

Remember, creating a referral process and patient base as a new gastroenterologist doesn’t have to be daunting. If you follow these tips, you’ll be on your way to establishing yourself within the community. No doubt you will have the same success as many physicians in my group and in the groups of my colleagues in the Digestive Health Physicians Association. And once you’re established, it will be your turn to help the next generation of physicians who want to enter private practice and thrive – so that independent community GI care remains strong well into the future.

Dr. Alaparthi is the director of committee operations at the Gastroenterology Center of Connecticut and serves as chair of the communications committee for the Digestive Health Physicians Association.

During my medical training and fellowship, I often heard that my education was not preparing me for the real world. After 3 years of internal medicine training with limited exposure to the outpatient arena and 3-4 years of specialty gastroenterology, hepatology, and advanced procedure training, you’ve probably heard the same thing. If you’ve chosen private practice, the thought of building a practice and establishing referrals probably seems daunting. It doesn’t have to be. Most gastroenterologists who enter private practice have felt this way early on, and our experiences can help you navigate some of the major factors that influence clinical practice to build a thriving career in gastroenterology.

Conduct research on referrals

Once you’ve decided to join a practice, do some research about local dynamics between large hospital systems and private practice. Community clinical practice is unique and varies by region, location, and how the practice is set up. GIs working in rural, low-access areas face different challenges than those working in urban areas near major health care systems. In rural, low-access areas, some physicians have long wait lists for office appointments and procedures.

In urban settings, there may be a larger population of patients but more competition from hospital systems and other practices. In this case, you’ll have to figure out where most of the referrals come from and why – is it the group’s overall reputation or are there physicians in the practice with a highly needed specialty?

Determine if your specialty training can be a differentiator in your market. If you are multilingual and there is a large patient population that speaks the language(s) in which you are fluent, this can be a great way to bring new patients into a practice. This is especially true if there aren’t many (or any) physicians in the practice who are multilingual.

Meet with local physicians in health care systems. Make a connection with hospitalists, referring physicians, ED physicians, advanced practitioners, and surgeons while covering inpatient service. Volunteer for teaching activities – including for nursing staff, who are a great referral source.

Figure out what opportunities exist to have direct interactions with patients, such as health fairs. If possible, it might be smart to invest in marketing directly to patients in your community as well. Leverage opportunities provided by awareness months – such as providing patients with information about cancer screening – to establish a referral basis.

Medical practice is complex and at times can be confusing until you’ve practiced in a given location for some time. Look internally to learn about the community. It’s always a good idea to learn from those who have been practicing in the community for a long time. Don’t hesitate to ask questions and make suggestions, even if they seem naive. Develop relationships with staff members and gain their trust. Establishing a clear understanding of your specialty with your colleagues and staff also can be a good way to find referrals.

Learn the internal process

Schedules during early months are usually filled with urgent patients. Make yourself available for overflow referrals to other established physicians within the practice and for hospital discharge follow-ups. Reading through the charts of these patients can help you understand the various styles of other doctors and can help you familiarize yourself with referring physicians.

This also will help to clarify the process of how a patient moves through the system – from the time patients call the office to when they check out. This includes navigating through procedures, results reporting, and the recall system. While it will be hard to master all aspects of a practice right away, processes within practices are well established, and it is important for you to have a good understanding of how they function.

Focus on patient care and satisfaction

Learning internal processes also can be useful in increasing patient satisfaction, an important quality outcome indicator. As you’re starting out, keep the following things in mind that can help put your patients at ease and increase satisfaction.

• Understand how to communicate what a patient should expect when being seen. Being at ease with the process helps garner trust and confidence.
• Call patients the next day to check on their symptoms.
• Relay results personally. Make connections with family member(s).
• Remember that cultural competency is important. Do everything you can to ensure you’re meeting the social, cultural, and linguistic needs of patients in your community.
• Above all – continue to provide personalized and thorough care. Word of mouth is the best form of referral and is time tested.

Continue to grow

As you begin to understand the dynamics of local practice, it’s important to establish where you fit into the practice and start differentiating your expertise. Here are some ideas and suggestions for how you can continue to expand your patient base.

• Differentiate and establish a subspecialty within your practice: Motility, inflammatory bowel disease, Clostridium difficile/fecal microbiota transplantation, liver diseases, Celiac disease, and medical weight-loss programs are just a few.
• Establish connections with local medical societies as well as hospital and state committees. This is a great way to connect with other physicians of various specialties. If you have a specialty unique to the area, it may help establish a clear referral line.
• Establish a consistent conversation with referring physicians – get to know them and keep direct lines of communication, such as having their cell phone numbers.
• Look for public speaking engagements that reach patients directly. These are organized mostly through patient-based organization and foundations.
• Increase your reach through the local media and through social media platforms like Facebook, Instagram, and Twitter.

At this point, you should have plenty of patients to keep you busy, which could lead to other challenges in managing your various responsibilities and obligations. A key factor at this stage to help reduce stress is to lean on the effective and efficient support system your practice should have in place. Educating medical assistants or nurses on the most common GI diseases and conditions can help reduce the time involved in communicating results. Practice management software and patient portals can help create efficiencies to handle the increasing number of patient visits.

Remember, creating a referral process and patient base as a new gastroenterologist doesn’t have to be daunting. If you follow these tips, you’ll be on your way to establishing yourself within the community. No doubt you will have the same success as many physicians in my group and in the groups of my colleagues in the Digestive Health Physicians Association. And once you’re established, it will be your turn to help the next generation of physicians who want to enter private practice and thrive – so that independent community GI care remains strong well into the future.

Dr. Alaparthi is the director of committee operations at the Gastroenterology Center of Connecticut and serves as chair of the communications committee for the Digestive Health Physicians Association.

During my medical training and fellowship, I often heard that my education was not preparing me for the real world. After 3 years of internal medicine training with limited exposure to the outpatient arena and 3-4 years of specialty gastroenterology, hepatology, and advanced procedure training, you’ve probably heard the same thing. If you’ve chosen private practice, the thought of building a practice and establishing referrals probably seems daunting. It doesn’t have to be. Most gastroenterologists who enter private practice have felt this way early on, and our experiences can help you navigate some of the major factors that influence clinical practice to build a thriving career in gastroenterology.

Conduct research on referrals

Once you’ve decided to join a practice, do some research about local dynamics between large hospital systems and private practice. Community clinical practice is unique and varies by region, location, and how the practice is set up. GIs working in rural, low-access areas face different challenges than those working in urban areas near major health care systems. In rural, low-access areas, some physicians have long wait lists for office appointments and procedures.

In urban settings, there may be a larger population of patients but more competition from hospital systems and other practices. In this case, you’ll have to figure out where most of the referrals come from and why – is it the group’s overall reputation or are there physicians in the practice with a highly needed specialty?

Determine if your specialty training can be a differentiator in your market. If you are multilingual and there is a large patient population that speaks the language(s) in which you are fluent, this can be a great way to bring new patients into a practice. This is especially true if there aren’t many (or any) physicians in the practice who are multilingual.

Meet with local physicians in health care systems. Make a connection with hospitalists, referring physicians, ED physicians, advanced practitioners, and surgeons while covering inpatient service. Volunteer for teaching activities – including for nursing staff, who are a great referral source.

Figure out what opportunities exist to have direct interactions with patients, such as health fairs. If possible, it might be smart to invest in marketing directly to patients in your community as well. Leverage opportunities provided by awareness months – such as providing patients with information about cancer screening – to establish a referral basis.

Medical practice is complex and at times can be confusing until you’ve practiced in a given location for some time. Look internally to learn about the community. It’s always a good idea to learn from those who have been practicing in the community for a long time. Don’t hesitate to ask questions and make suggestions, even if they seem naive. Develop relationships with staff members and gain their trust. Establishing a clear understanding of your specialty with your colleagues and staff also can be a good way to find referrals.

Learn the internal process

Schedules during early months are usually filled with urgent patients. Make yourself available for overflow referrals to other established physicians within the practice and for hospital discharge follow-ups. Reading through the charts of these patients can help you understand the various styles of other doctors and can help you familiarize yourself with referring physicians.

This also will help to clarify the process of how a patient moves through the system – from the time patients call the office to when they check out. This includes navigating through procedures, results reporting, and the recall system. While it will be hard to master all aspects of a practice right away, processes within practices are well established, and it is important for you to have a good understanding of how they function.

Focus on patient care and satisfaction

Learning internal processes also can be useful in increasing patient satisfaction, an important quality outcome indicator. As you’re starting out, keep the following things in mind that can help put your patients at ease and increase satisfaction.

• Understand how to communicate what a patient should expect when being seen. Being at ease with the process helps garner trust and confidence.
• Call patients the next day to check on their symptoms.
• Relay results personally. Make connections with family member(s).
• Remember that cultural competency is important. Do everything you can to ensure you’re meeting the social, cultural, and linguistic needs of patients in your community.
• Above all – continue to provide personalized and thorough care. Word of mouth is the best form of referral and is time tested.

Continue to grow

As you begin to understand the dynamics of local practice, it’s important to establish where you fit into the practice and start differentiating your expertise. Here are some ideas and suggestions for how you can continue to expand your patient base.

• Differentiate and establish a subspecialty within your practice: Motility, inflammatory bowel disease, Clostridium difficile/fecal microbiota transplantation, liver diseases, Celiac disease, and medical weight-loss programs are just a few.
• Establish connections with local medical societies as well as hospital and state committees. This is a great way to connect with other physicians of various specialties. If you have a specialty unique to the area, it may help establish a clear referral line.
• Establish a consistent conversation with referring physicians – get to know them and keep direct lines of communication, such as having their cell phone numbers.
• Look for public speaking engagements that reach patients directly. These are organized mostly through patient-based organization and foundations.
• Increase your reach through the local media and through social media platforms like Facebook, Instagram, and Twitter.

At this point, you should have plenty of patients to keep you busy, which could lead to other challenges in managing your various responsibilities and obligations. A key factor at this stage to help reduce stress is to lean on the effective and efficient support system your practice should have in place. Educating medical assistants or nurses on the most common GI diseases and conditions can help reduce the time involved in communicating results. Practice management software and patient portals can help create efficiencies to handle the increasing number of patient visits.

Remember, creating a referral process and patient base as a new gastroenterologist doesn’t have to be daunting. If you follow these tips, you’ll be on your way to establishing yourself within the community. No doubt you will have the same success as many physicians in my group and in the groups of my colleagues in the Digestive Health Physicians Association. And once you’re established, it will be your turn to help the next generation of physicians who want to enter private practice and thrive – so that independent community GI care remains strong well into the future.

Dr. Alaparthi is the director of committee operations at the Gastroenterology Center of Connecticut and serves as chair of the communications committee for the Digestive Health Physicians Association.

Physician registrants can get a big boost in collecting required Continuing Medical Education (CME) and Maintenance of Certification (MOC) self-assessment credits at the Vascular Annual Meeting.

The Society for Vascular Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. SVS has designated the 2019 Vascular Annual Meeting for a maximum of 30 AMA PRA Category 1 Credits™.

Physicians should claim only the credits commensurate with the extent of their participation in the activity.

Full credit is not available for attendance at two sessions occurring simultaneously.

A number of sessions also permit earning of MOC credits.

Participants may claim credits beginning Wednesday, June 12. Credits must be claimed by Dec. 31, 2019. 

Physician registrants can get a big boost in collecting required Continuing Medical Education (CME) and Maintenance of Certification (MOC) self-assessment credits at the Vascular Annual Meeting.

The Society for Vascular Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. SVS has designated the 2019 Vascular Annual Meeting for a maximum of 30 AMA PRA Category 1 Credits™.

Physicians should claim only the credits commensurate with the extent of their participation in the activity.

Full credit is not available for attendance at two sessions occurring simultaneously.

A number of sessions also permit earning of MOC credits.

Participants may claim credits beginning Wednesday, June 12. Credits must be claimed by Dec. 31, 2019. 

Physician registrants can get a big boost in collecting required Continuing Medical Education (CME) and Maintenance of Certification (MOC) self-assessment credits at the Vascular Annual Meeting.

The Society for Vascular Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. SVS has designated the 2019 Vascular Annual Meeting for a maximum of 30 AMA PRA Category 1 Credits™.

Physicians should claim only the credits commensurate with the extent of their participation in the activity.

Full credit is not available for attendance at two sessions occurring simultaneously.

A number of sessions also permit earning of MOC credits.

Participants may claim credits beginning Wednesday, June 12. Credits must be claimed by Dec. 31, 2019. 

A tradition at the Vascular Annual Meeting, the E. Stanley Crawford Critical Issues Forum is organized by the incoming SVS President and devotes itself to assessing and discussing particular challenges currently facing the society. This year’s Forum focused on how vascular surgeons could use evidence-based medicine to develop tools to improve outcomes, reduce costs, and ensure appropriate utilization of resources.

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Session moderator and organizer Kim J. Hodgson, MD, SVS president-elect and chair of the division of vascular surgery at Southern Illinois University School of Medicine, outlined the problem in his introductory presentation “Why Good Outcomes Are No Longer Good Enough.”

He pointed out how there are several driving forces influencing the inappropriate use of medical procedures, resulting in diminished quality of outcomes and increased costs of health care: These comprise incorrect evaluation, incorrect treatment and planning, and improper motivation. The first two factors can be improved through education and development and promulgation of evidence-based medical practices, but the last is correctable only through enforced regulation and peer-review. This has become increasingly more difficult as procedures move from the hospital to outpatient centers, where the profit motive for performing inappropriate procedures, and the means to satisfy it, are increasingly more tempting.

He emphasized how SVS has tools such as the Vascular Quality Initiative and its registries to provide evidence-based input on the appropriateness of procedures and whether an institution is matching up to its peers in providing appropriate patient care. The importance of the VQI was also stressed by the majority of the Crawford Forum speakers.

“Unfortunately, like it or not, the reality is that some degree of regulation is inevitable, and if we don’t step up and regulate ourselves, there are plenty of other people willing to do it for us. I would say that we let the bureaucrats develop our EHRs, and you know how that worked out. So, I think it is incumbent upon us to be able to regulate ourselves.”

Dr. Hodgson turned over the discussion to Arlene Seid, MD, MPH, medical director of the quality assurance office within the Pennsylvania Department of Health. Her presentation, “The Government’s Perspective on When & Where Endovascular Interventions Should Be Performed,” detailed how her department recently became concerned about an increase in the volume of endovascular procedures, and complications thereof, mainly in outpatient settings. The department also raised questions about the procedures and discussed whether reimbursement via programs such as Medicaid should be ceased.

She pointed out how federal regulations from the Centers for Medicare & Medicaid Services (CMS) only regulate through payments and their choice of procedures to be reimbursed, the vast majority of other regulations are established at the state level and vary widely from state to state. And at the state level, such as hers, there was great difficulty finding trustworthy expert opinion, and she added how organizations like the SVS could be of tremendous use in providing guidance in developing regulations.

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As an example she used Ambulatory Surgical Centers, which are defined differently from state to state and vary widely in their requirements for licensing. The state’s job is made much simpler, and more effective, when expert organizations like the SVS can provide certification programs as a firm foundation for basing such licensing efforts.

She also suggested that if individuals have problems with or disagree with state regulations, they must become knowledgeable as to what level of state organization is involved, and ideally enlist the help of groups such as SVS to provide the expert justification for change.

A tradition at the Vascular Annual Meeting, the E. Stanley Crawford Critical Issues Forum is organized by the incoming SVS President and devotes itself to assessing and discussing particular challenges currently facing the society. This year’s Forum focused on how vascular surgeons could use evidence-based medicine to develop tools to improve outcomes, reduce costs, and ensure appropriate utilization of resources.

Nationwide Photographers

Session moderator and organizer Kim J. Hodgson, MD, SVS president-elect and chair of the division of vascular surgery at Southern Illinois University School of Medicine, outlined the problem in his introductory presentation “Why Good Outcomes Are No Longer Good Enough.”

He pointed out how there are several driving forces influencing the inappropriate use of medical procedures, resulting in diminished quality of outcomes and increased costs of health care: These comprise incorrect evaluation, incorrect treatment and planning, and improper motivation. The first two factors can be improved through education and development and promulgation of evidence-based medical practices, but the last is correctable only through enforced regulation and peer-review. This has become increasingly more difficult as procedures move from the hospital to outpatient centers, where the profit motive for performing inappropriate procedures, and the means to satisfy it, are increasingly more tempting.

He emphasized how SVS has tools such as the Vascular Quality Initiative and its registries to provide evidence-based input on the appropriateness of procedures and whether an institution is matching up to its peers in providing appropriate patient care. The importance of the VQI was also stressed by the majority of the Crawford Forum speakers.

“Unfortunately, like it or not, the reality is that some degree of regulation is inevitable, and if we don’t step up and regulate ourselves, there are plenty of other people willing to do it for us. I would say that we let the bureaucrats develop our EHRs, and you know how that worked out. So, I think it is incumbent upon us to be able to regulate ourselves.”

Dr. Hodgson turned over the discussion to Arlene Seid, MD, MPH, medical director of the quality assurance office within the Pennsylvania Department of Health. Her presentation, “The Government’s Perspective on When & Where Endovascular Interventions Should Be Performed,” detailed how her department recently became concerned about an increase in the volume of endovascular procedures, and complications thereof, mainly in outpatient settings. The department also raised questions about the procedures and discussed whether reimbursement via programs such as Medicaid should be ceased.

She pointed out how federal regulations from the Centers for Medicare & Medicaid Services (CMS) only regulate through payments and their choice of procedures to be reimbursed, the vast majority of other regulations are established at the state level and vary widely from state to state. And at the state level, such as hers, there was great difficulty finding trustworthy expert opinion, and she added how organizations like the SVS could be of tremendous use in providing guidance in developing regulations.

Nationwide Photographers

As an example she used Ambulatory Surgical Centers, which are defined differently from state to state and vary widely in their requirements for licensing. The state’s job is made much simpler, and more effective, when expert organizations like the SVS can provide certification programs as a firm foundation for basing such licensing efforts.

She also suggested that if individuals have problems with or disagree with state regulations, they must become knowledgeable as to what level of state organization is involved, and ideally enlist the help of groups such as SVS to provide the expert justification for change.

A tradition at the Vascular Annual Meeting, the E. Stanley Crawford Critical Issues Forum is organized by the incoming SVS President and devotes itself to assessing and discussing particular challenges currently facing the society. This year’s Forum focused on how vascular surgeons could use evidence-based medicine to develop tools to improve outcomes, reduce costs, and ensure appropriate utilization of resources.

Nationwide Photographers

Session moderator and organizer Kim J. Hodgson, MD, SVS president-elect and chair of the division of vascular surgery at Southern Illinois University School of Medicine, outlined the problem in his introductory presentation “Why Good Outcomes Are No Longer Good Enough.”

He pointed out how there are several driving forces influencing the inappropriate use of medical procedures, resulting in diminished quality of outcomes and increased costs of health care: These comprise incorrect evaluation, incorrect treatment and planning, and improper motivation. The first two factors can be improved through education and development and promulgation of evidence-based medical practices, but the last is correctable only through enforced regulation and peer-review. This has become increasingly more difficult as procedures move from the hospital to outpatient centers, where the profit motive for performing inappropriate procedures, and the means to satisfy it, are increasingly more tempting.

He emphasized how SVS has tools such as the Vascular Quality Initiative and its registries to provide evidence-based input on the appropriateness of procedures and whether an institution is matching up to its peers in providing appropriate patient care. The importance of the VQI was also stressed by the majority of the Crawford Forum speakers.

“Unfortunately, like it or not, the reality is that some degree of regulation is inevitable, and if we don’t step up and regulate ourselves, there are plenty of other people willing to do it for us. I would say that we let the bureaucrats develop our EHRs, and you know how that worked out. So, I think it is incumbent upon us to be able to regulate ourselves.”

Dr. Hodgson turned over the discussion to Arlene Seid, MD, MPH, medical director of the quality assurance office within the Pennsylvania Department of Health. Her presentation, “The Government’s Perspective on When & Where Endovascular Interventions Should Be Performed,” detailed how her department recently became concerned about an increase in the volume of endovascular procedures, and complications thereof, mainly in outpatient settings. The department also raised questions about the procedures and discussed whether reimbursement via programs such as Medicaid should be ceased.

She pointed out how federal regulations from the Centers for Medicare & Medicaid Services (CMS) only regulate through payments and their choice of procedures to be reimbursed, the vast majority of other regulations are established at the state level and vary widely from state to state. And at the state level, such as hers, there was great difficulty finding trustworthy expert opinion, and she added how organizations like the SVS could be of tremendous use in providing guidance in developing regulations.

Nationwide Photographers

As an example she used Ambulatory Surgical Centers, which are defined differently from state to state and vary widely in their requirements for licensing. The state’s job is made much simpler, and more effective, when expert organizations like the SVS can provide certification programs as a firm foundation for basing such licensing efforts.

She also suggested that if individuals have problems with or disagree with state regulations, they must become knowledgeable as to what level of state organization is involved, and ideally enlist the help of groups such as SVS to provide the expert justification for change.