A self-management program called SMART can help patients with epilepsy reduce the risk of negative health events according to researchers at Case Western Reserve University School of Medicine.

• A 6-month randomized controlled trial of the community-based program included 60 adult patients and was compared to 60 control patients on a waitlist.
• The experiment monitored a variety of events, including seizures, accidents, attempts at self-harm, emergency department visits, and hospitalizations.
• The average patient in this trial was about 41 years old, about 70% were African American, 74% were unemployed.
• Patients who were randomized to the SMART program had fewer negative health events by 6 months compared to controls.
• SMART was also linked to improved scores on the Patient Health Questionnaire (P=.002), the 10 item Quality of Life in Epilepsy Inventory, and the Short Form Health Survey.

Sajatovic  M, Colon-Zimmermann K,  Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. [Published online ahead of print August 10, 2018]. Epilepsia. https://doi.org/10.1111/epi.14527.

A self-management program called SMART can help patients with epilepsy reduce the risk of negative health events according to researchers at Case Western Reserve University School of Medicine.

• A 6-month randomized controlled trial of the community-based program included 60 adult patients and was compared to 60 control patients on a waitlist.
• The experiment monitored a variety of events, including seizures, accidents, attempts at self-harm, emergency department visits, and hospitalizations.
• The average patient in this trial was about 41 years old, about 70% were African American, 74% were unemployed.
• Patients who were randomized to the SMART program had fewer negative health events by 6 months compared to controls.
• SMART was also linked to improved scores on the Patient Health Questionnaire (P=.002), the 10 item Quality of Life in Epilepsy Inventory, and the Short Form Health Survey.

Sajatovic  M, Colon-Zimmermann K,  Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. [Published online ahead of print August 10, 2018]. Epilepsia. https://doi.org/10.1111/epi.14527.

A self-management program called SMART can help patients with epilepsy reduce the risk of negative health events according to researchers at Case Western Reserve University School of Medicine.

• A 6-month randomized controlled trial of the community-based program included 60 adult patients and was compared to 60 control patients on a waitlist.
• The experiment monitored a variety of events, including seizures, accidents, attempts at self-harm, emergency department visits, and hospitalizations.
• The average patient in this trial was about 41 years old, about 70% were African American, 74% were unemployed.
• Patients who were randomized to the SMART program had fewer negative health events by 6 months compared to controls.
• SMART was also linked to improved scores on the Patient Health Questionnaire (P=.002), the 10 item Quality of Life in Epilepsy Inventory, and the Short Form Health Survey.

Sajatovic  M, Colon-Zimmermann K,  Kahriman M, et al. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. [Published online ahead of print August 10, 2018]. Epilepsia. https://doi.org/10.1111/epi.14527.

The Food and Drug Administration has placed a partial clinical hold on a phase 1b/2 study of OXi4503, a vascular disrupting agent.

In this trial (NCT02576301), researchers are evaluating OXi4503 alone and in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The partial clinical hold applies to the 12.2 mg/m² dose of OXi4503. The FDA is allowing the continued treatment and enrollment of patients using a dose of 9.76 mg/m². Additional data on patients receiving OXi4503 at 9.76 mg/m² must be evaluated before dosing at 12.2 mg/m² can be resumed.

The partial clinical hold is a result of two potential dose-limiting toxicities (DLTs) observed at the 12.2-mg/m² dose level: hypotension, which occurred shortly after initial treatment with OXi4503, and acute hypoxic respiratory failure, which occurred approximately 2 weeks after receiving OXi4503 and cytarabine.

Both events were deemed “possibly related” to OXi4503, and both patients recovered following treatment.

“Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed 2 complete remissions in the 4 patients that we treated,” William D. Schwieterman, MD, chief executive officer of Mateon Therapeutics Inc., the company developing OXi4503, said in a statement.

In preclinical research, OXi4503 demonstrated activity against AML, both when given alone and in combination with bevacizumab. These results were published in Blood in 2010.

In a phase 1 trial (NCT01085656), researchers evaluated OXi4503 in patients with relapsed or refractory AML or MDS. OXi4503 demonstrated preliminary evidence of disease response in heavily pretreated, refractory AML and advanced MDS.

The maximum tolerated dose of OXi4503 was not identified, but adverse events attributable to the drug included hypertension, bone pain, fever, anemia, thrombocytopenia, and coagulopathies.

Results from this study were presented at the 2013 annual meeting of the American Society of Hematology.

In 2015, Mateon Therapeutics initiated the phase 1b/2 study of OXi4503 (NCT02576301) that is now on partial clinical hold.

The phase 1 portion of this study was designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent OXi4503 in patients with relapsed/refractory AML and MDS. It is also aimed at determining the safety, pharmacokinetics, and pharmacodynamics of OXi4503 plus intermediate-dose cytarabine.

The goal of the phase 2 portion is to assess the preliminary efficacy of OXi4503 and cytarabine in patients with AML and MDS.

[email protected]

The Food and Drug Administration has placed a partial clinical hold on a phase 1b/2 study of OXi4503, a vascular disrupting agent.

In this trial (NCT02576301), researchers are evaluating OXi4503 alone and in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The partial clinical hold applies to the 12.2 mg/m² dose of OXi4503. The FDA is allowing the continued treatment and enrollment of patients using a dose of 9.76 mg/m². Additional data on patients receiving OXi4503 at 9.76 mg/m² must be evaluated before dosing at 12.2 mg/m² can be resumed.

The partial clinical hold is a result of two potential dose-limiting toxicities (DLTs) observed at the 12.2-mg/m² dose level: hypotension, which occurred shortly after initial treatment with OXi4503, and acute hypoxic respiratory failure, which occurred approximately 2 weeks after receiving OXi4503 and cytarabine.

Both events were deemed “possibly related” to OXi4503, and both patients recovered following treatment.

“Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed 2 complete remissions in the 4 patients that we treated,” William D. Schwieterman, MD, chief executive officer of Mateon Therapeutics Inc., the company developing OXi4503, said in a statement.

In preclinical research, OXi4503 demonstrated activity against AML, both when given alone and in combination with bevacizumab. These results were published in Blood in 2010.

In a phase 1 trial (NCT01085656), researchers evaluated OXi4503 in patients with relapsed or refractory AML or MDS. OXi4503 demonstrated preliminary evidence of disease response in heavily pretreated, refractory AML and advanced MDS.

The maximum tolerated dose of OXi4503 was not identified, but adverse events attributable to the drug included hypertension, bone pain, fever, anemia, thrombocytopenia, and coagulopathies.

Results from this study were presented at the 2013 annual meeting of the American Society of Hematology.

In 2015, Mateon Therapeutics initiated the phase 1b/2 study of OXi4503 (NCT02576301) that is now on partial clinical hold.

The phase 1 portion of this study was designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent OXi4503 in patients with relapsed/refractory AML and MDS. It is also aimed at determining the safety, pharmacokinetics, and pharmacodynamics of OXi4503 plus intermediate-dose cytarabine.

The goal of the phase 2 portion is to assess the preliminary efficacy of OXi4503 and cytarabine in patients with AML and MDS.

[email protected]

The Food and Drug Administration has placed a partial clinical hold on a phase 1b/2 study of OXi4503, a vascular disrupting agent.

In this trial (NCT02576301), researchers are evaluating OXi4503 alone and in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The partial clinical hold applies to the 12.2 mg/m² dose of OXi4503. The FDA is allowing the continued treatment and enrollment of patients using a dose of 9.76 mg/m². Additional data on patients receiving OXi4503 at 9.76 mg/m² must be evaluated before dosing at 12.2 mg/m² can be resumed.

The partial clinical hold is a result of two potential dose-limiting toxicities (DLTs) observed at the 12.2-mg/m² dose level: hypotension, which occurred shortly after initial treatment with OXi4503, and acute hypoxic respiratory failure, which occurred approximately 2 weeks after receiving OXi4503 and cytarabine.

Both events were deemed “possibly related” to OXi4503, and both patients recovered following treatment.

“Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed 2 complete remissions in the 4 patients that we treated,” William D. Schwieterman, MD, chief executive officer of Mateon Therapeutics Inc., the company developing OXi4503, said in a statement.

In preclinical research, OXi4503 demonstrated activity against AML, both when given alone and in combination with bevacizumab. These results were published in Blood in 2010.

In a phase 1 trial (NCT01085656), researchers evaluated OXi4503 in patients with relapsed or refractory AML or MDS. OXi4503 demonstrated preliminary evidence of disease response in heavily pretreated, refractory AML and advanced MDS.

The maximum tolerated dose of OXi4503 was not identified, but adverse events attributable to the drug included hypertension, bone pain, fever, anemia, thrombocytopenia, and coagulopathies.

Results from this study were presented at the 2013 annual meeting of the American Society of Hematology.

In 2015, Mateon Therapeutics initiated the phase 1b/2 study of OXi4503 (NCT02576301) that is now on partial clinical hold.

The phase 1 portion of this study was designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent OXi4503 in patients with relapsed/refractory AML and MDS. It is also aimed at determining the safety, pharmacokinetics, and pharmacodynamics of OXi4503 plus intermediate-dose cytarabine.

The goal of the phase 2 portion is to assess the preliminary efficacy of OXi4503 and cytarabine in patients with AML and MDS.

[email protected]

Patients with psychogenic nonepileptic seizures (PNES) are more likely to suffer from sleep complaints than are patients with epilepsy according to an analysis conducted by clinicians at the Brigham and Women’s Hospital.

• 149 patients with PNES and 82 patients with epilepsy completed the Beck Depression Inventory and the Quality of Life in Epilepsy Inventory-10.
• By analyzing item 16 on the Beck Depression Inventory, which looks at changes in sleep patterns, the investigators found that PNES patients were more likely to report moderate to severe changes in sleep patterns, including waking up too early, sleeping less than usual, and having trouble falling back to sleep.
• The sleep complaints were associated with poorer quality of life, suggesting that they need to be addressed more closely in PNES patients.

Latreille V, Baslet G, Sarkis R, et al. Sleep in psychogenic nonepileptic seizures: time to raise a red flag. Epilepsy Behav. 2018;86:6-8.

Patients with psychogenic nonepileptic seizures (PNES) are more likely to suffer from sleep complaints than are patients with epilepsy according to an analysis conducted by clinicians at the Brigham and Women’s Hospital.

• 149 patients with PNES and 82 patients with epilepsy completed the Beck Depression Inventory and the Quality of Life in Epilepsy Inventory-10.
• By analyzing item 16 on the Beck Depression Inventory, which looks at changes in sleep patterns, the investigators found that PNES patients were more likely to report moderate to severe changes in sleep patterns, including waking up too early, sleeping less than usual, and having trouble falling back to sleep.
• The sleep complaints were associated with poorer quality of life, suggesting that they need to be addressed more closely in PNES patients.

Latreille V, Baslet G, Sarkis R, et al. Sleep in psychogenic nonepileptic seizures: time to raise a red flag. Epilepsy Behav. 2018;86:6-8.

Patients with psychogenic nonepileptic seizures (PNES) are more likely to suffer from sleep complaints than are patients with epilepsy according to an analysis conducted by clinicians at the Brigham and Women’s Hospital.

• 149 patients with PNES and 82 patients with epilepsy completed the Beck Depression Inventory and the Quality of Life in Epilepsy Inventory-10.
• By analyzing item 16 on the Beck Depression Inventory, which looks at changes in sleep patterns, the investigators found that PNES patients were more likely to report moderate to severe changes in sleep patterns, including waking up too early, sleeping less than usual, and having trouble falling back to sleep.
• The sleep complaints were associated with poorer quality of life, suggesting that they need to be addressed more closely in PNES patients.

Latreille V, Baslet G, Sarkis R, et al. Sleep in psychogenic nonepileptic seizures: time to raise a red flag. Epilepsy Behav. 2018;86:6-8.

Although patients with epilepsy can benefit from self-management programs, a recent analysis from the Centers for Disease Control and Prevention has found that competency in self-management skills varies considerably across behavioral domains.

• Data from the Prevention Managing Epilepsy Well Network found that competencies in information and lifestyle management were considerably weaker than competencies in medication, safety, and seizure management.
• The Managing Epilepsy Well database analysis included 436 patients with epilepsy from 5 studies in the United States.
• Self-management behavioral skills were stronger in females and among patients with less education.
• The same skills were weaker in patients with depression and in those who reported a lower quality of life.

Begley C, Shegog R, Liu H, et al. Correlates of epilepsy self-management in MEW Network participants: From the Centers for Disease Control and Prevention Managing Epilepsy Well Network. Epilepsy Behav. 2018;85:243-247.

Although patients with epilepsy can benefit from self-management programs, a recent analysis from the Centers for Disease Control and Prevention has found that competency in self-management skills varies considerably across behavioral domains.

• Data from the Prevention Managing Epilepsy Well Network found that competencies in information and lifestyle management were considerably weaker than competencies in medication, safety, and seizure management.
• The Managing Epilepsy Well database analysis included 436 patients with epilepsy from 5 studies in the United States.
• Self-management behavioral skills were stronger in females and among patients with less education.
• The same skills were weaker in patients with depression and in those who reported a lower quality of life.

Begley C, Shegog R, Liu H, et al. Correlates of epilepsy self-management in MEW Network participants: From the Centers for Disease Control and Prevention Managing Epilepsy Well Network. Epilepsy Behav. 2018;85:243-247.

Although patients with epilepsy can benefit from self-management programs, a recent analysis from the Centers for Disease Control and Prevention has found that competency in self-management skills varies considerably across behavioral domains.

• Data from the Prevention Managing Epilepsy Well Network found that competencies in information and lifestyle management were considerably weaker than competencies in medication, safety, and seizure management.
• The Managing Epilepsy Well database analysis included 436 patients with epilepsy from 5 studies in the United States.
• Self-management behavioral skills were stronger in females and among patients with less education.
• The same skills were weaker in patients with depression and in those who reported a lower quality of life.

Begley C, Shegog R, Liu H, et al. Correlates of epilepsy self-management in MEW Network participants: From the Centers for Disease Control and Prevention Managing Epilepsy Well Network. Epilepsy Behav. 2018;85:243-247.

Clinical question

What is the optimal way to manage analgesia during neonatal circumcision?

Background

Neonatal circumcision is one of the most commonly performed surgical procedures. The American Academy of Pediatrics in 2012 noted that the health benefits outweigh the minor risks of the procedure, but that parents should make the decision to circumcise based on their own cultural, ethical, and religious beliefs.

One of the primary risks of neonatal circumcision is pain during and after the procedure. Multiple methods for managing analgesia exist, but it is unknown what combination of methods is optimal. Usual analgesia techniques include: local anesthetic cream composed of lidocaine and prilocaine (EMLA) applied to the skin prior to the procedure; oral sucrose solution given throughout the procedure; dorsal penile nerve block (DPNB); and penile ring block (RB).
 

Study design

Single-center, double-blinded, randomized, controlled trial.

Setting

Multispecialty freestanding hospital.

Synopsis

Parents of infant boys born at 36-41 weeks’ gestation who chose to have their children circumcised were offered participation in the study. Of 83 eligible participants, 70 were randomized, with 10 in the control group (EMLA only) and 20 in each intervention (EMLA + sucrose, EMLA + sucrose + RB, EMLA + sucrose + DPNB). A single pediatric urologist performed all circumcisions using the Gomco clamp technique.

A video camera recorded the infant’s face and upper torso during the procedure. Two researchers, who were blinded to the analgesia plan, scored these videos using a modified Neonatal Infant Pain Scale (NIPS). The NIPS used ranged from 0 to 6, with 6 considered severe pain. For rating purposes, the procedure was divided into 6 stages with a NIPS score assigned at each stage. There were no significant differences in baseline characteristics among the groups; no significant differences in the duration of the procedure by intervention; and there were no complications. Interrater reliability for the NIPS was good (kappa, 0.84). All interventions were superior to EMLA alone, with significantly decreased NIPS for all stages of the procedure. No significant differences in NIPS were found among the following:

EMLA + sucrose.

EMLA + sucrose + RB.

EMLA + sucrose + DPNB (for any stage of the procedure).



The one exception was that following lysis of foreskin adhesions, EMLA + sucrose + RB was superior (NIPS 2.25 for EMLA + sucrose + RB vs. NIPS 4.4 for EMLA + sucrose + DPNB vs. NIPS 4.3 for EMLA + sucrose vs. NIPS 5.8 for EMLA alone). In terms of crying time during the procedure, all interventions were significantly superior to EMLA alone. Of the interventions, crying time was statistically and clinically significantly shorter with EMLA + sucrose + RB (5.78 seconds vs. 11.5 for EMLA + sucrose + DPNB vs. 16.5 for EMLA + sucrose vs. 45.4 for EMLA alone). This was a single-center study and the procedures were performed by a pediatric urologist rather than by a general pediatrician, which potentially limits applicability.
 

Bottom line

All tested analgesia modalities for neonatal circumcision were superior to EMLA alone. The most effective analgesia of those tested was EMLA + sucrose + penile ring block.

Citation

Sharara-Chami R et al. Combination analgesia for neonatal circumcision: a randomized controlled trial. Pediatrics. 2017. doi: 10.1542/peds.2017-1935.

Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., and a clinical assistant professor of pediatrics at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia.

Clinical question

What is the optimal way to manage analgesia during neonatal circumcision?

Background

Neonatal circumcision is one of the most commonly performed surgical procedures. The American Academy of Pediatrics in 2012 noted that the health benefits outweigh the minor risks of the procedure, but that parents should make the decision to circumcise based on their own cultural, ethical, and religious beliefs.

One of the primary risks of neonatal circumcision is pain during and after the procedure. Multiple methods for managing analgesia exist, but it is unknown what combination of methods is optimal. Usual analgesia techniques include: local anesthetic cream composed of lidocaine and prilocaine (EMLA) applied to the skin prior to the procedure; oral sucrose solution given throughout the procedure; dorsal penile nerve block (DPNB); and penile ring block (RB).
 

Study design

Single-center, double-blinded, randomized, controlled trial.

Setting

Multispecialty freestanding hospital.

Synopsis

Parents of infant boys born at 36-41 weeks’ gestation who chose to have their children circumcised were offered participation in the study. Of 83 eligible participants, 70 were randomized, with 10 in the control group (EMLA only) and 20 in each intervention (EMLA + sucrose, EMLA + sucrose + RB, EMLA + sucrose + DPNB). A single pediatric urologist performed all circumcisions using the Gomco clamp technique.

A video camera recorded the infant’s face and upper torso during the procedure. Two researchers, who were blinded to the analgesia plan, scored these videos using a modified Neonatal Infant Pain Scale (NIPS). The NIPS used ranged from 0 to 6, with 6 considered severe pain. For rating purposes, the procedure was divided into 6 stages with a NIPS score assigned at each stage. There were no significant differences in baseline characteristics among the groups; no significant differences in the duration of the procedure by intervention; and there were no complications. Interrater reliability for the NIPS was good (kappa, 0.84). All interventions were superior to EMLA alone, with significantly decreased NIPS for all stages of the procedure. No significant differences in NIPS were found among the following:

EMLA + sucrose.

EMLA + sucrose + RB.

EMLA + sucrose + DPNB (for any stage of the procedure).



The one exception was that following lysis of foreskin adhesions, EMLA + sucrose + RB was superior (NIPS 2.25 for EMLA + sucrose + RB vs. NIPS 4.4 for EMLA + sucrose + DPNB vs. NIPS 4.3 for EMLA + sucrose vs. NIPS 5.8 for EMLA alone). In terms of crying time during the procedure, all interventions were significantly superior to EMLA alone. Of the interventions, crying time was statistically and clinically significantly shorter with EMLA + sucrose + RB (5.78 seconds vs. 11.5 for EMLA + sucrose + DPNB vs. 16.5 for EMLA + sucrose vs. 45.4 for EMLA alone). This was a single-center study and the procedures were performed by a pediatric urologist rather than by a general pediatrician, which potentially limits applicability.
 

Bottom line

All tested analgesia modalities for neonatal circumcision were superior to EMLA alone. The most effective analgesia of those tested was EMLA + sucrose + penile ring block.

Citation

Sharara-Chami R et al. Combination analgesia for neonatal circumcision: a randomized controlled trial. Pediatrics. 2017. doi: 10.1542/peds.2017-1935.

Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., and a clinical assistant professor of pediatrics at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia.

Clinical question

What is the optimal way to manage analgesia during neonatal circumcision?

Background

Neonatal circumcision is one of the most commonly performed surgical procedures. The American Academy of Pediatrics in 2012 noted that the health benefits outweigh the minor risks of the procedure, but that parents should make the decision to circumcise based on their own cultural, ethical, and religious beliefs.

One of the primary risks of neonatal circumcision is pain during and after the procedure. Multiple methods for managing analgesia exist, but it is unknown what combination of methods is optimal. Usual analgesia techniques include: local anesthetic cream composed of lidocaine and prilocaine (EMLA) applied to the skin prior to the procedure; oral sucrose solution given throughout the procedure; dorsal penile nerve block (DPNB); and penile ring block (RB).
 

Study design

Single-center, double-blinded, randomized, controlled trial.

Setting

Multispecialty freestanding hospital.

Synopsis

Parents of infant boys born at 36-41 weeks’ gestation who chose to have their children circumcised were offered participation in the study. Of 83 eligible participants, 70 were randomized, with 10 in the control group (EMLA only) and 20 in each intervention (EMLA + sucrose, EMLA + sucrose + RB, EMLA + sucrose + DPNB). A single pediatric urologist performed all circumcisions using the Gomco clamp technique.

A video camera recorded the infant’s face and upper torso during the procedure. Two researchers, who were blinded to the analgesia plan, scored these videos using a modified Neonatal Infant Pain Scale (NIPS). The NIPS used ranged from 0 to 6, with 6 considered severe pain. For rating purposes, the procedure was divided into 6 stages with a NIPS score assigned at each stage. There were no significant differences in baseline characteristics among the groups; no significant differences in the duration of the procedure by intervention; and there were no complications. Interrater reliability for the NIPS was good (kappa, 0.84). All interventions were superior to EMLA alone, with significantly decreased NIPS for all stages of the procedure. No significant differences in NIPS were found among the following:

EMLA + sucrose.

EMLA + sucrose + RB.

EMLA + sucrose + DPNB (for any stage of the procedure).



The one exception was that following lysis of foreskin adhesions, EMLA + sucrose + RB was superior (NIPS 2.25 for EMLA + sucrose + RB vs. NIPS 4.4 for EMLA + sucrose + DPNB vs. NIPS 4.3 for EMLA + sucrose vs. NIPS 5.8 for EMLA alone). In terms of crying time during the procedure, all interventions were significantly superior to EMLA alone. Of the interventions, crying time was statistically and clinically significantly shorter with EMLA + sucrose + RB (5.78 seconds vs. 11.5 for EMLA + sucrose + DPNB vs. 16.5 for EMLA + sucrose vs. 45.4 for EMLA alone). This was a single-center study and the procedures were performed by a pediatric urologist rather than by a general pediatrician, which potentially limits applicability.
 

Bottom line

All tested analgesia modalities for neonatal circumcision were superior to EMLA alone. The most effective analgesia of those tested was EMLA + sucrose + penile ring block.

Citation

Sharara-Chami R et al. Combination analgesia for neonatal circumcision: a randomized controlled trial. Pediatrics. 2017. doi: 10.1542/peds.2017-1935.

Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., and a clinical assistant professor of pediatrics at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia.

The Food and Drug Administration has cleared the way for marketing of the BrainsWay deep transcranial magnetic stimulation system for treating patients with treatment-resistant obsessive-compulsive disorder (OCD).

“With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in an Aug. 17 news release.

The clearance is based on results of a randomized, multicenter study of 100 patients,49 of whom were treated with the BrainsWay device and 51 of whom with a sham device. Of the patients treated with the BrainsWay device, 38% had a 30% or greater reduction in their Yale-Brown Obsessive Compulsive Scale scores, which measures severity of OCD symptoms, whereas only 11% treated with the sham device experienced such a reduction.

The most common adverse reaction was headache, experienced by 37.5% of patients treated with the BrainsWay device and 35.0% of those treated with the sham device. No serious adverse events were reported. Other common reactions included application site pain or discomfort, spasm or twitching, and jaw, facial, muscle, or neck pain; all of those were reported as mild or moderate and resolved quickly after each treatment was completed.

The device is contraindicated in patients with any sort of metal in or near their heads, such as cochlear implants or vagus nerve stimulators. Patients with a history of seizure should discuss it with their health care clinician.

Transcranial magnetic stimulation also has been approved to treat major depressive disorder and migraine with aura.

The full press release can be found on the FDA website.

[email protected]

The Food and Drug Administration has cleared the way for marketing of the BrainsWay deep transcranial magnetic stimulation system for treating patients with treatment-resistant obsessive-compulsive disorder (OCD).

“With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in an Aug. 17 news release.

The clearance is based on results of a randomized, multicenter study of 100 patients,49 of whom were treated with the BrainsWay device and 51 of whom with a sham device. Of the patients treated with the BrainsWay device, 38% had a 30% or greater reduction in their Yale-Brown Obsessive Compulsive Scale scores, which measures severity of OCD symptoms, whereas only 11% treated with the sham device experienced such a reduction.

The most common adverse reaction was headache, experienced by 37.5% of patients treated with the BrainsWay device and 35.0% of those treated with the sham device. No serious adverse events were reported. Other common reactions included application site pain or discomfort, spasm or twitching, and jaw, facial, muscle, or neck pain; all of those were reported as mild or moderate and resolved quickly after each treatment was completed.

The device is contraindicated in patients with any sort of metal in or near their heads, such as cochlear implants or vagus nerve stimulators. Patients with a history of seizure should discuss it with their health care clinician.

Transcranial magnetic stimulation also has been approved to treat major depressive disorder and migraine with aura.

The full press release can be found on the FDA website.

[email protected]

The Food and Drug Administration has cleared the way for marketing of the BrainsWay deep transcranial magnetic stimulation system for treating patients with treatment-resistant obsessive-compulsive disorder (OCD).

“With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in an Aug. 17 news release.

The clearance is based on results of a randomized, multicenter study of 100 patients,49 of whom were treated with the BrainsWay device and 51 of whom with a sham device. Of the patients treated with the BrainsWay device, 38% had a 30% or greater reduction in their Yale-Brown Obsessive Compulsive Scale scores, which measures severity of OCD symptoms, whereas only 11% treated with the sham device experienced such a reduction.

The most common adverse reaction was headache, experienced by 37.5% of patients treated with the BrainsWay device and 35.0% of those treated with the sham device. No serious adverse events were reported. Other common reactions included application site pain or discomfort, spasm or twitching, and jaw, facial, muscle, or neck pain; all of those were reported as mild or moderate and resolved quickly after each treatment was completed.

The device is contraindicated in patients with any sort of metal in or near their heads, such as cochlear implants or vagus nerve stimulators. Patients with a history of seizure should discuss it with their health care clinician.

Transcranial magnetic stimulation also has been approved to treat major depressive disorder and migraine with aura.

The full press release can be found on the FDA website.

[email protected]

The Food and Drug Administration has updated the prescribing information (PI) for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two separate FDA-approved companion diagnostic tests are now required to determine PD-L1 levels in tumor tissue for those who are cisplatin-ineligible.

Pembrolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy and whose tumors have a Combined Positive Score (CPS) for PD-L1 expression of greater than or equal to 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay for determining PD-L1 expression, through staining in tumor and immune cells, before prescribing pembrolizumab.

Atezolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy, and whose tumors show PD-L1 expression through stained tumor-infiltrating immune cells covering greater than or equal to 5% of the tumor area, or patients who are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression. The FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to determine PD L1 expression in immune cells before prescribing atezolizumab.

PI is updated for both drugs to require use of an FDA-approved test for selection of patients being treated in the first-line setting who are cisplatin-ineligible, but second-line indications in urothelial carcinoma for both drugs remain unchanged, according to an FDA statement.

[email protected]

The Food and Drug Administration has updated the prescribing information (PI) for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two separate FDA-approved companion diagnostic tests are now required to determine PD-L1 levels in tumor tissue for those who are cisplatin-ineligible.

Pembrolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy and whose tumors have a Combined Positive Score (CPS) for PD-L1 expression of greater than or equal to 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay for determining PD-L1 expression, through staining in tumor and immune cells, before prescribing pembrolizumab.

Atezolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy, and whose tumors show PD-L1 expression through stained tumor-infiltrating immune cells covering greater than or equal to 5% of the tumor area, or patients who are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression. The FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to determine PD L1 expression in immune cells before prescribing atezolizumab.

PI is updated for both drugs to require use of an FDA-approved test for selection of patients being treated in the first-line setting who are cisplatin-ineligible, but second-line indications in urothelial carcinoma for both drugs remain unchanged, according to an FDA statement.

[email protected]

The Food and Drug Administration has updated the prescribing information (PI) for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two separate FDA-approved companion diagnostic tests are now required to determine PD-L1 levels in tumor tissue for those who are cisplatin-ineligible.

Pembrolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy and whose tumors have a Combined Positive Score (CPS) for PD-L1 expression of greater than or equal to 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay for determining PD-L1 expression, through staining in tumor and immune cells, before prescribing pembrolizumab.

Atezolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy, and whose tumors show PD-L1 expression through stained tumor-infiltrating immune cells covering greater than or equal to 5% of the tumor area, or patients who are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression. The FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to determine PD L1 expression in immune cells before prescribing atezolizumab.

PI is updated for both drugs to require use of an FDA-approved test for selection of patients being treated in the first-line setting who are cisplatin-ineligible, but second-line indications in urothelial carcinoma for both drugs remain unchanged, according to an FDA statement.

[email protected]

NEW ORLEANS – Both the neutrophil-to-lymphocyte ratio and the platelet-to-lymphocyte ratio proved to be better predictors of the presence or absence of deep vein thrombosis than the ubiquitous D-dimer test in a retrospective study, Jason Mouabbi, MD, reported at the annual meeting of the American College of Physicians.

What’s more, both the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) can be readily calculated from the readout of a complete blood count (CBC) with differential. A CBC costs an average of $16, and everybody that comes through a hospital emergency department gets one. In contrast, the average charge for a D-dimer test is about $231 nationwide, and depending upon the specific test used the results can take up to a couple of hours to come back, noted Dr. Mouabbi of St. John Hospital and Medical Center in Detroit.

“The NLR and PLR ratios offer a new, powerful, affordable, simple, and readily available tool in the hands of clinicians to help them in the diagnosis of DVT,” he said. “The NLR can be useful to rule out DVT when it’s negative, whereas PLR can be useful in ruling DVT when positive.”

Investigators in a variety of fields are looking at the NLR and PLR as emerging practical, easily obtainable biomarkers for systemic inflammation. And DVT is thought to be an inflammatory process, he explained.

Dr. Mouabbi presented a single-center retrospective study of 102 matched patients who presented with lower extremity swelling and had a CBC drawn, as well as a D-dimer test, on the same day they underwent a lower extremity Doppler ultrasound evaluation. In 51 patients, the ultrasound revealed the presence of DVT and anticoagulation was started. In the other 51 patients, the ultrasound exam was negative and they weren’t anticoagulated. Since the study purpose was to assess the implications of a primary elevation of NLR and/or PLR, patients with rheumatic diseases, inflammatory bowel disease, recent surgery, chronic renal or liver disease, inherited thrombophilia, infection, or other possible secondary causes of altered ratios were excluded from the study.

A positive NLR was considered 3.4 or higher, a positive PLR was a ratio of 230 or more, and a positive D-dimer level was 500 ng/mL or greater. The NLR and PLR collectively outperformed the D-dimer test in terms of sensitivity, specificity, positive predictive value, and negative predictive value.

In addition, 89% of the DVT group were classified as “double-positive,” meaning they were both NLR and PLR positive. That combination provided the best diagnostic value of all, since none of the controls were double-positive and only 2% were PLR positive.

While the results are encouraging, before NLR and PLR can supplant D-dimer in patients with suspected DVT in clinical practice a confirmatory prospective study should be carried out, according to Dr. Mouabbi. Ideally it should include the use of the Wells score, which is part of most diagnostic algorithms as a preliminary means of categorizing DVT probability as low, moderate, or high. However, the popularity of the Wells score has fallen off in the face of reports that the results are subjective and variable. Indeed, the Wells score was included in the electronic medical record of so few participants in Dr. Mouabbi’s study that he couldn’t evaluate its utility.

He reported having no financial conflicts regarding his study, which was conducted free of commercial support.

[email protected]

NEW ORLEANS – Both the neutrophil-to-lymphocyte ratio and the platelet-to-lymphocyte ratio proved to be better predictors of the presence or absence of deep vein thrombosis than the ubiquitous D-dimer test in a retrospective study, Jason Mouabbi, MD, reported at the annual meeting of the American College of Physicians.

What’s more, both the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) can be readily calculated from the readout of a complete blood count (CBC) with differential. A CBC costs an average of $16, and everybody that comes through a hospital emergency department gets one. In contrast, the average charge for a D-dimer test is about $231 nationwide, and depending upon the specific test used the results can take up to a couple of hours to come back, noted Dr. Mouabbi of St. John Hospital and Medical Center in Detroit.

“The NLR and PLR ratios offer a new, powerful, affordable, simple, and readily available tool in the hands of clinicians to help them in the diagnosis of DVT,” he said. “The NLR can be useful to rule out DVT when it’s negative, whereas PLR can be useful in ruling DVT when positive.”

Investigators in a variety of fields are looking at the NLR and PLR as emerging practical, easily obtainable biomarkers for systemic inflammation. And DVT is thought to be an inflammatory process, he explained.

Dr. Mouabbi presented a single-center retrospective study of 102 matched patients who presented with lower extremity swelling and had a CBC drawn, as well as a D-dimer test, on the same day they underwent a lower extremity Doppler ultrasound evaluation. In 51 patients, the ultrasound revealed the presence of DVT and anticoagulation was started. In the other 51 patients, the ultrasound exam was negative and they weren’t anticoagulated. Since the study purpose was to assess the implications of a primary elevation of NLR and/or PLR, patients with rheumatic diseases, inflammatory bowel disease, recent surgery, chronic renal or liver disease, inherited thrombophilia, infection, or other possible secondary causes of altered ratios were excluded from the study.

A positive NLR was considered 3.4 or higher, a positive PLR was a ratio of 230 or more, and a positive D-dimer level was 500 ng/mL or greater. The NLR and PLR collectively outperformed the D-dimer test in terms of sensitivity, specificity, positive predictive value, and negative predictive value.

In addition, 89% of the DVT group were classified as “double-positive,” meaning they were both NLR and PLR positive. That combination provided the best diagnostic value of all, since none of the controls were double-positive and only 2% were PLR positive.

While the results are encouraging, before NLR and PLR can supplant D-dimer in patients with suspected DVT in clinical practice a confirmatory prospective study should be carried out, according to Dr. Mouabbi. Ideally it should include the use of the Wells score, which is part of most diagnostic algorithms as a preliminary means of categorizing DVT probability as low, moderate, or high. However, the popularity of the Wells score has fallen off in the face of reports that the results are subjective and variable. Indeed, the Wells score was included in the electronic medical record of so few participants in Dr. Mouabbi’s study that he couldn’t evaluate its utility.

He reported having no financial conflicts regarding his study, which was conducted free of commercial support.

[email protected]

NEW ORLEANS – Both the neutrophil-to-lymphocyte ratio and the platelet-to-lymphocyte ratio proved to be better predictors of the presence or absence of deep vein thrombosis than the ubiquitous D-dimer test in a retrospective study, Jason Mouabbi, MD, reported at the annual meeting of the American College of Physicians.

What’s more, both the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) can be readily calculated from the readout of a complete blood count (CBC) with differential. A CBC costs an average of $16, and everybody that comes through a hospital emergency department gets one. In contrast, the average charge for a D-dimer test is about $231 nationwide, and depending upon the specific test used the results can take up to a couple of hours to come back, noted Dr. Mouabbi of St. John Hospital and Medical Center in Detroit.

“The NLR and PLR ratios offer a new, powerful, affordable, simple, and readily available tool in the hands of clinicians to help them in the diagnosis of DVT,” he said. “The NLR can be useful to rule out DVT when it’s negative, whereas PLR can be useful in ruling DVT when positive.”

Investigators in a variety of fields are looking at the NLR and PLR as emerging practical, easily obtainable biomarkers for systemic inflammation. And DVT is thought to be an inflammatory process, he explained.

Dr. Mouabbi presented a single-center retrospective study of 102 matched patients who presented with lower extremity swelling and had a CBC drawn, as well as a D-dimer test, on the same day they underwent a lower extremity Doppler ultrasound evaluation. In 51 patients, the ultrasound revealed the presence of DVT and anticoagulation was started. In the other 51 patients, the ultrasound exam was negative and they weren’t anticoagulated. Since the study purpose was to assess the implications of a primary elevation of NLR and/or PLR, patients with rheumatic diseases, inflammatory bowel disease, recent surgery, chronic renal or liver disease, inherited thrombophilia, infection, or other possible secondary causes of altered ratios were excluded from the study.

A positive NLR was considered 3.4 or higher, a positive PLR was a ratio of 230 or more, and a positive D-dimer level was 500 ng/mL or greater. The NLR and PLR collectively outperformed the D-dimer test in terms of sensitivity, specificity, positive predictive value, and negative predictive value.

In addition, 89% of the DVT group were classified as “double-positive,” meaning they were both NLR and PLR positive. That combination provided the best diagnostic value of all, since none of the controls were double-positive and only 2% were PLR positive.

While the results are encouraging, before NLR and PLR can supplant D-dimer in patients with suspected DVT in clinical practice a confirmatory prospective study should be carried out, according to Dr. Mouabbi. Ideally it should include the use of the Wells score, which is part of most diagnostic algorithms as a preliminary means of categorizing DVT probability as low, moderate, or high. However, the popularity of the Wells score has fallen off in the face of reports that the results are subjective and variable. Indeed, the Wells score was included in the electronic medical record of so few participants in Dr. Mouabbi’s study that he couldn’t evaluate its utility.

He reported having no financial conflicts regarding his study, which was conducted free of commercial support.

[email protected]

“We’ll have one strawberry sugar cone, two chocolate swirls, and a mocha almond.”

iStock

“Dr. Wilkoff, I haven’t seen you in ... must be 5 years. You look great! How’s retirement going?”

“You look great too, Kim. The neighborhood has needed an ice cream parlor like yours for a long time. How’s the family?”

Alerted by the commotion of our catching up, Kim’s husband came outside to see what was going on. Looking at my wife, he said, “You know he saved our daughter’s life?”

Well, not exactly. A timely referral to a psychologist I knew was good with eating disorders had started the slow process of returning their anorectic daughter to health. I thanked him and tried to put a more historically correct spin on his story.

Most of my encounters with former patients and their parents aren’t as dramatic as this one at Kim’s Ice Cream Shack, but they always leave me with a warm, positive feeling that stays with me all day. Every now and then they include a compliment or a thank you, but most of the time the conversations are dominated by questions about how the other are doing and what our families are up to.

One of the perks of living in the town where you practice is that your patients also are your neighbors. Not every physician views this proximity as a positive, but for me, it was a gift that has kept on giving after I retired.

Our house phone number was always listed in the phone book, and I can count on the fingers of two hands how many times in 40 years that I received what I would consider an inappropriate or invasive call. Our office offered evening and weekend hours and a generous schedule of phone-in call times. But I’m convinced that it was the neighbor-to-neighbor relationship that kept the work/home balance intact. Even though I may have helped a plumber and his wife with their sick children, that professional arrangement didn’t include a free pass to call him after hours if I knew my leaking faucet could wait until the weekend was over.

By the same token, when a patient or a customer is also your neighbor there is an unspoken ethic that the service you provide must be your best effort. That’s not an admission that I was in the habit of offering substandard care to “folks from away,” but there is special motivation when your work is being scrutinized by people you’re likely to see next week at the grocery store checkout.

Office visits with neighbors often tended to take longer because there was a tendency to drift off topic and ask about a sibling’s baseball game I had read about in the paper or how the lobster catch was running that season. On the other hand, I must admit that I did my share of reporting (really it was bragging) on my own children’s accomplishments.

But now I’m reaping the benefits of those extra minutes invested in the office, because I suspect former patients and their families are more likely to want to reminisce when we meet in a restaurant or at the farmers’ market.

If you are a young physician and worrying about finding a good work/life balance, I urge you to consider living and working and then staying on in a place in which your patients also will be your neighbors. It will enrich your work experience and repay you many times over when it’s time to retire.

If you can’t find that place, at least treat your patients as though they were your neighbors.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

“We’ll have one strawberry sugar cone, two chocolate swirls, and a mocha almond.”

iStock

“Dr. Wilkoff, I haven’t seen you in ... must be 5 years. You look great! How’s retirement going?”

“You look great too, Kim. The neighborhood has needed an ice cream parlor like yours for a long time. How’s the family?”

Alerted by the commotion of our catching up, Kim’s husband came outside to see what was going on. Looking at my wife, he said, “You know he saved our daughter’s life?”

Well, not exactly. A timely referral to a psychologist I knew was good with eating disorders had started the slow process of returning their anorectic daughter to health. I thanked him and tried to put a more historically correct spin on his story.

Most of my encounters with former patients and their parents aren’t as dramatic as this one at Kim’s Ice Cream Shack, but they always leave me with a warm, positive feeling that stays with me all day. Every now and then they include a compliment or a thank you, but most of the time the conversations are dominated by questions about how the other are doing and what our families are up to.

One of the perks of living in the town where you practice is that your patients also are your neighbors. Not every physician views this proximity as a positive, but for me, it was a gift that has kept on giving after I retired.

Our house phone number was always listed in the phone book, and I can count on the fingers of two hands how many times in 40 years that I received what I would consider an inappropriate or invasive call. Our office offered evening and weekend hours and a generous schedule of phone-in call times. But I’m convinced that it was the neighbor-to-neighbor relationship that kept the work/home balance intact. Even though I may have helped a plumber and his wife with their sick children, that professional arrangement didn’t include a free pass to call him after hours if I knew my leaking faucet could wait until the weekend was over.

By the same token, when a patient or a customer is also your neighbor there is an unspoken ethic that the service you provide must be your best effort. That’s not an admission that I was in the habit of offering substandard care to “folks from away,” but there is special motivation when your work is being scrutinized by people you’re likely to see next week at the grocery store checkout.

Office visits with neighbors often tended to take longer because there was a tendency to drift off topic and ask about a sibling’s baseball game I had read about in the paper or how the lobster catch was running that season. On the other hand, I must admit that I did my share of reporting (really it was bragging) on my own children’s accomplishments.

But now I’m reaping the benefits of those extra minutes invested in the office, because I suspect former patients and their families are more likely to want to reminisce when we meet in a restaurant or at the farmers’ market.

If you are a young physician and worrying about finding a good work/life balance, I urge you to consider living and working and then staying on in a place in which your patients also will be your neighbors. It will enrich your work experience and repay you many times over when it’s time to retire.

If you can’t find that place, at least treat your patients as though they were your neighbors.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

“We’ll have one strawberry sugar cone, two chocolate swirls, and a mocha almond.”

iStock

“Dr. Wilkoff, I haven’t seen you in ... must be 5 years. You look great! How’s retirement going?”

“You look great too, Kim. The neighborhood has needed an ice cream parlor like yours for a long time. How’s the family?”

Alerted by the commotion of our catching up, Kim’s husband came outside to see what was going on. Looking at my wife, he said, “You know he saved our daughter’s life?”

Well, not exactly. A timely referral to a psychologist I knew was good with eating disorders had started the slow process of returning their anorectic daughter to health. I thanked him and tried to put a more historically correct spin on his story.

Most of my encounters with former patients and their parents aren’t as dramatic as this one at Kim’s Ice Cream Shack, but they always leave me with a warm, positive feeling that stays with me all day. Every now and then they include a compliment or a thank you, but most of the time the conversations are dominated by questions about how the other are doing and what our families are up to.

One of the perks of living in the town where you practice is that your patients also are your neighbors. Not every physician views this proximity as a positive, but for me, it was a gift that has kept on giving after I retired.

Our house phone number was always listed in the phone book, and I can count on the fingers of two hands how many times in 40 years that I received what I would consider an inappropriate or invasive call. Our office offered evening and weekend hours and a generous schedule of phone-in call times. But I’m convinced that it was the neighbor-to-neighbor relationship that kept the work/home balance intact. Even though I may have helped a plumber and his wife with their sick children, that professional arrangement didn’t include a free pass to call him after hours if I knew my leaking faucet could wait until the weekend was over.

By the same token, when a patient or a customer is also your neighbor there is an unspoken ethic that the service you provide must be your best effort. That’s not an admission that I was in the habit of offering substandard care to “folks from away,” but there is special motivation when your work is being scrutinized by people you’re likely to see next week at the grocery store checkout.

Office visits with neighbors often tended to take longer because there was a tendency to drift off topic and ask about a sibling’s baseball game I had read about in the paper or how the lobster catch was running that season. On the other hand, I must admit that I did my share of reporting (really it was bragging) on my own children’s accomplishments.

But now I’m reaping the benefits of those extra minutes invested in the office, because I suspect former patients and their families are more likely to want to reminisce when we meet in a restaurant or at the farmers’ market.

If you are a young physician and worrying about finding a good work/life balance, I urge you to consider living and working and then staying on in a place in which your patients also will be your neighbors. It will enrich your work experience and repay you many times over when it’s time to retire.

If you can’t find that place, at least treat your patients as though they were your neighbors.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Postapproval results for SynCardia Systems’ Companion 2 (C2) driver system for temporary total artificial hearts (TAH-t) have shown higher mortality and stroke rates than were seen with the previous system, the circulatory support system. As a result, the Food and Drug Administration has issued a safety alert cautioning them to weigh the risks and benefits carefully. The alert, issued on August 17, is based on a postapproval study conducted by SynCardia Systems.

Furthermore, patients and health care professionals are encouraged to report any adverse events using the FDA’s Medwatch reporting form, as well as return any devices associated with adverse events to the SynCardia Systems to help them and the FDA better understand the issue.

The C2 driver system is an external pneumatic system that activates an implanted TAH-t in eligible heart failure patients who have severe biventricular failure and are waiting for transplant. It is smaller than its predecessor, but per the device’s approved use, patients must still remain in the hospital while on the device. Since its approval in 2012, the Freedom driver system was approved in 2014, which allows patients to return home.

The full safety alert can be found on the FDA website.
 

[email protected]

Postapproval results for SynCardia Systems’ Companion 2 (C2) driver system for temporary total artificial hearts (TAH-t) have shown higher mortality and stroke rates than were seen with the previous system, the circulatory support system. As a result, the Food and Drug Administration has issued a safety alert cautioning them to weigh the risks and benefits carefully. The alert, issued on August 17, is based on a postapproval study conducted by SynCardia Systems.

Furthermore, patients and health care professionals are encouraged to report any adverse events using the FDA’s Medwatch reporting form, as well as return any devices associated with adverse events to the SynCardia Systems to help them and the FDA better understand the issue.

The C2 driver system is an external pneumatic system that activates an implanted TAH-t in eligible heart failure patients who have severe biventricular failure and are waiting for transplant. It is smaller than its predecessor, but per the device’s approved use, patients must still remain in the hospital while on the device. Since its approval in 2012, the Freedom driver system was approved in 2014, which allows patients to return home.

The full safety alert can be found on the FDA website.
 

[email protected]

Postapproval results for SynCardia Systems’ Companion 2 (C2) driver system for temporary total artificial hearts (TAH-t) have shown higher mortality and stroke rates than were seen with the previous system, the circulatory support system. As a result, the Food and Drug Administration has issued a safety alert cautioning them to weigh the risks and benefits carefully. The alert, issued on August 17, is based on a postapproval study conducted by SynCardia Systems.

Furthermore, patients and health care professionals are encouraged to report any adverse events using the FDA’s Medwatch reporting form, as well as return any devices associated with adverse events to the SynCardia Systems to help them and the FDA better understand the issue.

The C2 driver system is an external pneumatic system that activates an implanted TAH-t in eligible heart failure patients who have severe biventricular failure and are waiting for transplant. It is smaller than its predecessor, but per the device’s approved use, patients must still remain in the hospital while on the device. Since its approval in 2012, the Freedom driver system was approved in 2014, which allows patients to return home.

The full safety alert can be found on the FDA website.
 

[email protected]