Tobacco use is the leading preventable cause of death and disease in the United States,¹ but how best to help patients quit? US Public Health Service guidelines recommend a 2-tiered approach consisting of counseling and pharmaceutical treatment.² Because primary care physicians are busy caring for other patients, however, and pharmacists in our state can prescribe medication under collaborative practice agreements with physicians, we piloted a single-visit smoking cessation group intervention conducted by a pharmacist (NP) and health coach (HW).

Patients were recruited from 2 primary care practices to participate in a 2-hour group visit that included both behavioral and pharmacologic interventions. Follow-up phone calls and in-person visits with the health coach were made available, but were not part of the structured curriculum.

We used motivational interviewing to assist patients in developing individualized quit plans and offered small rewards for stopping, such as a note pad and 6-month certificate. Patients did not pay for the group visit, but were required to pay for pharmacotherapy (health insurance or out of pocket).

Between September 2011 and May 2012, a total of 35 patients attended one of 7 smoking cessation group visits. Twenty-seven (77%) participants opted for medication or nicotine replacement therapy and 23 (65.7%) used the health coach services.

As of June 2012—with participants ranging from one month to 9 months’ follow-up—23% remained tobacco free. This compares with documented one-year quit rates of 3% to 5% (unassisted), 7% to 16% (with behavioral intervention), and up to 24% with pharmacologic treatment and ongoing behavioral support.³ Similar smoking cessation rates have been described with multiple-session pharmacist-led group visits.⁴ This pilot program demonstrated that a single group intervention can be performed in a primary care setting with a pharmacist and health coach, freeing physicians to care for other patients.

Challenges include variable reimbursement from insurers for pharmacist-led tobacco cessation group visits and disparate pharmacy policies—pharmacists are not allowed to prescribe medication in every state. Nonetheless, this pilot, funded by Fairview Physician Associates and the University of Minnesota Academic Health Center, represents a promising means of delivering effective preventive services by leveraging team members in a busy primary care clinic.

Nicole Paterson, PharmD, BCPS
Holly Wiest, MA
Lynne Fiscus, MD, MPH 
Minneapolis, Minn

Tobacco use is the leading preventable cause of death and disease in the United States,¹ but how best to help patients quit? US Public Health Service guidelines recommend a 2-tiered approach consisting of counseling and pharmaceutical treatment.² Because primary care physicians are busy caring for other patients, however, and pharmacists in our state can prescribe medication under collaborative practice agreements with physicians, we piloted a single-visit smoking cessation group intervention conducted by a pharmacist (NP) and health coach (HW).

Patients were recruited from 2 primary care practices to participate in a 2-hour group visit that included both behavioral and pharmacologic interventions. Follow-up phone calls and in-person visits with the health coach were made available, but were not part of the structured curriculum.

We used motivational interviewing to assist patients in developing individualized quit plans and offered small rewards for stopping, such as a note pad and 6-month certificate. Patients did not pay for the group visit, but were required to pay for pharmacotherapy (health insurance or out of pocket).

Between September 2011 and May 2012, a total of 35 patients attended one of 7 smoking cessation group visits. Twenty-seven (77%) participants opted for medication or nicotine replacement therapy and 23 (65.7%) used the health coach services.

As of June 2012—with participants ranging from one month to 9 months’ follow-up—23% remained tobacco free. This compares with documented one-year quit rates of 3% to 5% (unassisted), 7% to 16% (with behavioral intervention), and up to 24% with pharmacologic treatment and ongoing behavioral support.³ Similar smoking cessation rates have been described with multiple-session pharmacist-led group visits.⁴ This pilot program demonstrated that a single group intervention can be performed in a primary care setting with a pharmacist and health coach, freeing physicians to care for other patients.

Challenges include variable reimbursement from insurers for pharmacist-led tobacco cessation group visits and disparate pharmacy policies—pharmacists are not allowed to prescribe medication in every state. Nonetheless, this pilot, funded by Fairview Physician Associates and the University of Minnesota Academic Health Center, represents a promising means of delivering effective preventive services by leveraging team members in a busy primary care clinic.

Nicole Paterson, PharmD, BCPS
Holly Wiest, MA
Lynne Fiscus, MD, MPH 
Minneapolis, Minn

Tobacco use is the leading preventable cause of death and disease in the United States,¹ but how best to help patients quit? US Public Health Service guidelines recommend a 2-tiered approach consisting of counseling and pharmaceutical treatment.² Because primary care physicians are busy caring for other patients, however, and pharmacists in our state can prescribe medication under collaborative practice agreements with physicians, we piloted a single-visit smoking cessation group intervention conducted by a pharmacist (NP) and health coach (HW).

Patients were recruited from 2 primary care practices to participate in a 2-hour group visit that included both behavioral and pharmacologic interventions. Follow-up phone calls and in-person visits with the health coach were made available, but were not part of the structured curriculum.

We used motivational interviewing to assist patients in developing individualized quit plans and offered small rewards for stopping, such as a note pad and 6-month certificate. Patients did not pay for the group visit, but were required to pay for pharmacotherapy (health insurance or out of pocket).

Between September 2011 and May 2012, a total of 35 patients attended one of 7 smoking cessation group visits. Twenty-seven (77%) participants opted for medication or nicotine replacement therapy and 23 (65.7%) used the health coach services.

As of June 2012—with participants ranging from one month to 9 months’ follow-up—23% remained tobacco free. This compares with documented one-year quit rates of 3% to 5% (unassisted), 7% to 16% (with behavioral intervention), and up to 24% with pharmacologic treatment and ongoing behavioral support.³ Similar smoking cessation rates have been described with multiple-session pharmacist-led group visits.⁴ This pilot program demonstrated that a single group intervention can be performed in a primary care setting with a pharmacist and health coach, freeing physicians to care for other patients.

Challenges include variable reimbursement from insurers for pharmacist-led tobacco cessation group visits and disparate pharmacy policies—pharmacists are not allowed to prescribe medication in every state. Nonetheless, this pilot, funded by Fairview Physician Associates and the University of Minnesota Academic Health Center, represents a promising means of delivering effective preventive services by leveraging team members in a busy primary care clinic.

Nicole Paterson, PharmD, BCPS
Holly Wiest, MA
Lynne Fiscus, MD, MPH 
Minneapolis, Minn

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AN OBGYN ENCOUNTERED SHOULDER DYSTOCIA. He used fundal pressure and downward lateral traction to free the baby’s shoulder. The child has a brachial plexus injury of the right shoulder, including nerve avulsion, a fractured clavicle, and permanent disfigurement. She underwent surgery; physical and occupational therapy will continue.

PARENTS' CLAIM The standard sequence of maneuvers should have been attempted before fundal pressure and lateral traction were used—the baby was sufficiently oxygenated to allow time for these maneuvers. Excessive lateral traction caused the injury.

DEFENDANTS' DEFENSE The injuries occurred in utero before or while the fetus progressed down the birth canal, and were due to the maternal forces of labor.

VERDICT A $3,070,000 Michigan verdict was returned against the hospital, ObGyn, and ObGyn group.

WHAT IS THE STANDARD SEQUENCE OF MANEUVERS FOR SHOULDER DYSTOCIA?
Read Dr. Robert L. Barbieri’s May Editorial, You are the second responder to a shoulder dystocia emergency. What do you do first? and Dr. Ronald T. Burkman’s March Stop/Start article, Stop all activities that may lead to further shoulder impaction when you suspect possible shoulder dystocia Meconium aspiration leads to brain injury

LATE IN HER PREGNANCY, a woman went to the emergency department (ED) with hypertension; she was discharged the same day. She saw her ObGyns, Dr. A and Dr. B, three times in the next 2 weeks. A day after her last visit, she returned to the ED in active labor. Dr. B assumed her care. Fetal monitoring indicated a nonreassuring heart rate with decelerations. Dr. B administered oxytocin and labor continued.

The baby was born by cesarean delivery after 25 minutes of fetal bradycardia. She was covered in meconium, with a low heart rate and irregular, labored respirations. The baby was transferred to another hospital, where she was treated for pulmonary hypertension, meconium aspiration, and seizures. The child is totally disabled, and will require constant care for life.

PARENTS' CLAIM The mother’s hypertension was not properly treated. Dr. B and the nurse waited too long to perform a cesarean delivery.

DEFENDANTS' DEFENSE Proper prenatal care was provided. There was no reason for additional testing; fetal heart tones at the mother’s last office visit were reactive. There were no clinical signs of a hematoma or cord varix during office visits. An unpredictable, unpreventable umbilical cord hematoma caused ischemia and hypoxia, and the subsequent brain injury. Meconium had been in the amniotic fluid for at least 10 hours due to the ischemic/hypoxic episode. The hematoma formed between her last office visit and when the mother came to the hospital the next day.

VERDICT Settlements were reached with Dr. A and the hospital. An Arkansas defense verdict was returned for Dr. B and the nurse.

14 months' recovery after mass removed

A GYNECOLOGIC ONCOLOGIST operated on a woman in her 50s to remove a large, noncancerous pelvic mass. The patient, discharged on postoperative day 2, was readmitted the next day with a fever (temperature, 103ºF), nausea, vomiting, and abdominal pain. Four days later, the oncologist repaired a perforated bowel and created an ileostomy. Other procedures were needed to drain abscesses and repair fistulas, and resect a large portion of colon due to continuing infection. Treatment lasted 14 months.

PATIENT'S CLAIM The gynecologic oncologist was negligent in failing to timely diagnose and treat the bowel perforation. Earlier repair would have curtailed development of the abscesses and fistulae.

PHYSICIAN'S DEFENSE Any complications the patient experienced were unrelated to any delay in treatment. 

VERDICT A $612,237 Michigan verdict was returned.

Colon perforated during abdominal access

WHEN A MORBIDLY OBESE 37-YEAR-OLD WOMAN reported chronic pelvic pain, her gynecologist suspected endometriosis. Conservative treatment failed and the gynecologist offered laparoscopic hysterectomy.

After abdominal insufflation was unsuccessfully attempted twice using a Veress needle, the gynecologist entered the abdomen with a Visiport optical trocar, and continued the procedure. The gynecologist inspected the abdomen before closing but found no injuries.

The patient did not do well after surgery. CT scan detected a bowel perforation on postoperative day 6. During exploratory laparotomy, a through-and-through “bayonet” colon perforation was repaired. Because of the extensive infection, the patient’s surgical wound was left open and several “washouts” were performed; the wound was closed several weeks later. The patient also underwent two adhesiolysis procedures.

PATIENT'S CLAIM Access to the abdomen was not properly performed and caused colon perforation. The injury should have been found and treated earlier.

PHYSICIAN'S DEFENSE The case was settled before trial.

VERDICT A $750,000 Virginia settlement was reached.

READ How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy, by Michael Baggish, MD (Surgical Techniques, October 2012) What caused this C. diff infection after hysterectomy?

AFTER A HYSTERECTOMY, a 42-year-old woman developed a persistent fever and increased white blood cell count. The gynecologist prescribed ciprofloxacin for a urinary tract infection, and discharged the patient from the hospital on postoperative day 4. She returned to the gynecologist’s office with severe abdominal pain and vomiting 4 days after discharge. The gynecologist prescribed an antacid and told her to continue taking ciprofloxacin.

The patient was taken to the ED by ambulance 3 days later. Testing revealed a Clostridium dificule (C. diff) infection. During emergency surgery, a large portion of her colon was resected, and a colostomy was performed. The colostomy was reversed 6 months later. The patient developed an incisional hernia and has abdominal scarring.

PATIENT'S CLAIM Prophylactic antibiotics should have been prescribed before surgery.

Two possible scenarios were presented: 1) A bowel injury occurred during surgery, and ciprofloxacin likely worsened the infection caused by the bowel injury; or 2) ciprofloxacin triggered the C. diff infection that caused leaking colon perforations and subsequent peritonitis.

The colon perforations could have been avoided if the gynecologist had diagnosed and treated the C. diff infection in a timely manner.

PHYSICIAN'S DEFENSE The patient’s symptoms did not suggest a C. diff infection; testing was not necessary. Ciprofloxacin might have allowed the proliferation of the C. diff infection, but the use of the drug was not negligent. The infection was not preventable and could not have been diagnosed earlier.

VERDICT A $776,000 New York verdict was returned.

Brain injury and cerebral palsy: When did this occur?

DURING LABOR AND DELIVERY, there were periods when the fetal heart-rate tracings were nonreassuring with variable decelerations and fetal tachycardia; some variables were severe. The child suffered anoxic encephalopathy that caused neurologic injury and cerebral palsy.

PARENTS' CLAIM The infant suffered numerous hypoxic incidents before cesarean delivery was performed. An earlier cesarean delivery could have prevented the injury.

PHYSICIAN'S DEFENSE The newborn had a normal blood cord gas level of 7.2 pH and Apgar scores of 9 and 10, at 1 and 5 minutes, respectively. Fetal heart-rate tracings did not show evidence of fetal hypoxia. The brain injury likely occurred prior to the onset of labor and was possibly related to a viral encephalopathy. 

VERDICT A Virginia defense verdict was returned. These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

gb

AN OBGYN ENCOUNTERED SHOULDER DYSTOCIA. He used fundal pressure and downward lateral traction to free the baby’s shoulder. The child has a brachial plexus injury of the right shoulder, including nerve avulsion, a fractured clavicle, and permanent disfigurement. She underwent surgery; physical and occupational therapy will continue.

PARENTS' CLAIM The standard sequence of maneuvers should have been attempted before fundal pressure and lateral traction were used—the baby was sufficiently oxygenated to allow time for these maneuvers. Excessive lateral traction caused the injury.

DEFENDANTS' DEFENSE The injuries occurred in utero before or while the fetus progressed down the birth canal, and were due to the maternal forces of labor.

VERDICT A $3,070,000 Michigan verdict was returned against the hospital, ObGyn, and ObGyn group.

WHAT IS THE STANDARD SEQUENCE OF MANEUVERS FOR SHOULDER DYSTOCIA?
Read Dr. Robert L. Barbieri’s May Editorial, You are the second responder to a shoulder dystocia emergency. What do you do first? and Dr. Ronald T. Burkman’s March Stop/Start article, Stop all activities that may lead to further shoulder impaction when you suspect possible shoulder dystocia Meconium aspiration leads to brain injury

LATE IN HER PREGNANCY, a woman went to the emergency department (ED) with hypertension; she was discharged the same day. She saw her ObGyns, Dr. A and Dr. B, three times in the next 2 weeks. A day after her last visit, she returned to the ED in active labor. Dr. B assumed her care. Fetal monitoring indicated a nonreassuring heart rate with decelerations. Dr. B administered oxytocin and labor continued.

The baby was born by cesarean delivery after 25 minutes of fetal bradycardia. She was covered in meconium, with a low heart rate and irregular, labored respirations. The baby was transferred to another hospital, where she was treated for pulmonary hypertension, meconium aspiration, and seizures. The child is totally disabled, and will require constant care for life.

PARENTS' CLAIM The mother’s hypertension was not properly treated. Dr. B and the nurse waited too long to perform a cesarean delivery.

DEFENDANTS' DEFENSE Proper prenatal care was provided. There was no reason for additional testing; fetal heart tones at the mother’s last office visit were reactive. There were no clinical signs of a hematoma or cord varix during office visits. An unpredictable, unpreventable umbilical cord hematoma caused ischemia and hypoxia, and the subsequent brain injury. Meconium had been in the amniotic fluid for at least 10 hours due to the ischemic/hypoxic episode. The hematoma formed between her last office visit and when the mother came to the hospital the next day.

VERDICT Settlements were reached with Dr. A and the hospital. An Arkansas defense verdict was returned for Dr. B and the nurse.

14 months' recovery after mass removed

A GYNECOLOGIC ONCOLOGIST operated on a woman in her 50s to remove a large, noncancerous pelvic mass. The patient, discharged on postoperative day 2, was readmitted the next day with a fever (temperature, 103ºF), nausea, vomiting, and abdominal pain. Four days later, the oncologist repaired a perforated bowel and created an ileostomy. Other procedures were needed to drain abscesses and repair fistulas, and resect a large portion of colon due to continuing infection. Treatment lasted 14 months.

PATIENT'S CLAIM The gynecologic oncologist was negligent in failing to timely diagnose and treat the bowel perforation. Earlier repair would have curtailed development of the abscesses and fistulae.

PHYSICIAN'S DEFENSE Any complications the patient experienced were unrelated to any delay in treatment. 

VERDICT A $612,237 Michigan verdict was returned.

Colon perforated during abdominal access

WHEN A MORBIDLY OBESE 37-YEAR-OLD WOMAN reported chronic pelvic pain, her gynecologist suspected endometriosis. Conservative treatment failed and the gynecologist offered laparoscopic hysterectomy.

After abdominal insufflation was unsuccessfully attempted twice using a Veress needle, the gynecologist entered the abdomen with a Visiport optical trocar, and continued the procedure. The gynecologist inspected the abdomen before closing but found no injuries.

The patient did not do well after surgery. CT scan detected a bowel perforation on postoperative day 6. During exploratory laparotomy, a through-and-through “bayonet” colon perforation was repaired. Because of the extensive infection, the patient’s surgical wound was left open and several “washouts” were performed; the wound was closed several weeks later. The patient also underwent two adhesiolysis procedures.

PATIENT'S CLAIM Access to the abdomen was not properly performed and caused colon perforation. The injury should have been found and treated earlier.

PHYSICIAN'S DEFENSE The case was settled before trial.

VERDICT A $750,000 Virginia settlement was reached.

READ How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy, by Michael Baggish, MD (Surgical Techniques, October 2012) What caused this C. diff infection after hysterectomy?

AFTER A HYSTERECTOMY, a 42-year-old woman developed a persistent fever and increased white blood cell count. The gynecologist prescribed ciprofloxacin for a urinary tract infection, and discharged the patient from the hospital on postoperative day 4. She returned to the gynecologist’s office with severe abdominal pain and vomiting 4 days after discharge. The gynecologist prescribed an antacid and told her to continue taking ciprofloxacin.

The patient was taken to the ED by ambulance 3 days later. Testing revealed a Clostridium dificule (C. diff) infection. During emergency surgery, a large portion of her colon was resected, and a colostomy was performed. The colostomy was reversed 6 months later. The patient developed an incisional hernia and has abdominal scarring.

PATIENT'S CLAIM Prophylactic antibiotics should have been prescribed before surgery.

Two possible scenarios were presented: 1) A bowel injury occurred during surgery, and ciprofloxacin likely worsened the infection caused by the bowel injury; or 2) ciprofloxacin triggered the C. diff infection that caused leaking colon perforations and subsequent peritonitis.

The colon perforations could have been avoided if the gynecologist had diagnosed and treated the C. diff infection in a timely manner.

PHYSICIAN'S DEFENSE The patient’s symptoms did not suggest a C. diff infection; testing was not necessary. Ciprofloxacin might have allowed the proliferation of the C. diff infection, but the use of the drug was not negligent. The infection was not preventable and could not have been diagnosed earlier.

VERDICT A $776,000 New York verdict was returned.

Brain injury and cerebral palsy: When did this occur?

DURING LABOR AND DELIVERY, there were periods when the fetal heart-rate tracings were nonreassuring with variable decelerations and fetal tachycardia; some variables were severe. The child suffered anoxic encephalopathy that caused neurologic injury and cerebral palsy.

PARENTS' CLAIM The infant suffered numerous hypoxic incidents before cesarean delivery was performed. An earlier cesarean delivery could have prevented the injury.

PHYSICIAN'S DEFENSE The newborn had a normal blood cord gas level of 7.2 pH and Apgar scores of 9 and 10, at 1 and 5 minutes, respectively. Fetal heart-rate tracings did not show evidence of fetal hypoxia. The brain injury likely occurred prior to the onset of labor and was possibly related to a viral encephalopathy. 

VERDICT A Virginia defense verdict was returned. These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

gb

AN OBGYN ENCOUNTERED SHOULDER DYSTOCIA. He used fundal pressure and downward lateral traction to free the baby’s shoulder. The child has a brachial plexus injury of the right shoulder, including nerve avulsion, a fractured clavicle, and permanent disfigurement. She underwent surgery; physical and occupational therapy will continue.

PARENTS' CLAIM The standard sequence of maneuvers should have been attempted before fundal pressure and lateral traction were used—the baby was sufficiently oxygenated to allow time for these maneuvers. Excessive lateral traction caused the injury.

DEFENDANTS' DEFENSE The injuries occurred in utero before or while the fetus progressed down the birth canal, and were due to the maternal forces of labor.

VERDICT A $3,070,000 Michigan verdict was returned against the hospital, ObGyn, and ObGyn group.

WHAT IS THE STANDARD SEQUENCE OF MANEUVERS FOR SHOULDER DYSTOCIA?
Read Dr. Robert L. Barbieri’s May Editorial, You are the second responder to a shoulder dystocia emergency. What do you do first? and Dr. Ronald T. Burkman’s March Stop/Start article, Stop all activities that may lead to further shoulder impaction when you suspect possible shoulder dystocia Meconium aspiration leads to brain injury

LATE IN HER PREGNANCY, a woman went to the emergency department (ED) with hypertension; she was discharged the same day. She saw her ObGyns, Dr. A and Dr. B, three times in the next 2 weeks. A day after her last visit, she returned to the ED in active labor. Dr. B assumed her care. Fetal monitoring indicated a nonreassuring heart rate with decelerations. Dr. B administered oxytocin and labor continued.

The baby was born by cesarean delivery after 25 minutes of fetal bradycardia. She was covered in meconium, with a low heart rate and irregular, labored respirations. The baby was transferred to another hospital, where she was treated for pulmonary hypertension, meconium aspiration, and seizures. The child is totally disabled, and will require constant care for life.

PARENTS' CLAIM The mother’s hypertension was not properly treated. Dr. B and the nurse waited too long to perform a cesarean delivery.

DEFENDANTS' DEFENSE Proper prenatal care was provided. There was no reason for additional testing; fetal heart tones at the mother’s last office visit were reactive. There were no clinical signs of a hematoma or cord varix during office visits. An unpredictable, unpreventable umbilical cord hematoma caused ischemia and hypoxia, and the subsequent brain injury. Meconium had been in the amniotic fluid for at least 10 hours due to the ischemic/hypoxic episode. The hematoma formed between her last office visit and when the mother came to the hospital the next day.

VERDICT Settlements were reached with Dr. A and the hospital. An Arkansas defense verdict was returned for Dr. B and the nurse.

14 months' recovery after mass removed

A GYNECOLOGIC ONCOLOGIST operated on a woman in her 50s to remove a large, noncancerous pelvic mass. The patient, discharged on postoperative day 2, was readmitted the next day with a fever (temperature, 103ºF), nausea, vomiting, and abdominal pain. Four days later, the oncologist repaired a perforated bowel and created an ileostomy. Other procedures were needed to drain abscesses and repair fistulas, and resect a large portion of colon due to continuing infection. Treatment lasted 14 months.

PATIENT'S CLAIM The gynecologic oncologist was negligent in failing to timely diagnose and treat the bowel perforation. Earlier repair would have curtailed development of the abscesses and fistulae.

PHYSICIAN'S DEFENSE Any complications the patient experienced were unrelated to any delay in treatment. 

VERDICT A $612,237 Michigan verdict was returned.

Colon perforated during abdominal access

WHEN A MORBIDLY OBESE 37-YEAR-OLD WOMAN reported chronic pelvic pain, her gynecologist suspected endometriosis. Conservative treatment failed and the gynecologist offered laparoscopic hysterectomy.

After abdominal insufflation was unsuccessfully attempted twice using a Veress needle, the gynecologist entered the abdomen with a Visiport optical trocar, and continued the procedure. The gynecologist inspected the abdomen before closing but found no injuries.

The patient did not do well after surgery. CT scan detected a bowel perforation on postoperative day 6. During exploratory laparotomy, a through-and-through “bayonet” colon perforation was repaired. Because of the extensive infection, the patient’s surgical wound was left open and several “washouts” were performed; the wound was closed several weeks later. The patient also underwent two adhesiolysis procedures.

PATIENT'S CLAIM Access to the abdomen was not properly performed and caused colon perforation. The injury should have been found and treated earlier.

PHYSICIAN'S DEFENSE The case was settled before trial.

VERDICT A $750,000 Virginia settlement was reached.

READ How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy, by Michael Baggish, MD (Surgical Techniques, October 2012) What caused this C. diff infection after hysterectomy?

AFTER A HYSTERECTOMY, a 42-year-old woman developed a persistent fever and increased white blood cell count. The gynecologist prescribed ciprofloxacin for a urinary tract infection, and discharged the patient from the hospital on postoperative day 4. She returned to the gynecologist’s office with severe abdominal pain and vomiting 4 days after discharge. The gynecologist prescribed an antacid and told her to continue taking ciprofloxacin.

The patient was taken to the ED by ambulance 3 days later. Testing revealed a Clostridium dificule (C. diff) infection. During emergency surgery, a large portion of her colon was resected, and a colostomy was performed. The colostomy was reversed 6 months later. The patient developed an incisional hernia and has abdominal scarring.

PATIENT'S CLAIM Prophylactic antibiotics should have been prescribed before surgery.

Two possible scenarios were presented: 1) A bowel injury occurred during surgery, and ciprofloxacin likely worsened the infection caused by the bowel injury; or 2) ciprofloxacin triggered the C. diff infection that caused leaking colon perforations and subsequent peritonitis.

The colon perforations could have been avoided if the gynecologist had diagnosed and treated the C. diff infection in a timely manner.

PHYSICIAN'S DEFENSE The patient’s symptoms did not suggest a C. diff infection; testing was not necessary. Ciprofloxacin might have allowed the proliferation of the C. diff infection, but the use of the drug was not negligent. The infection was not preventable and could not have been diagnosed earlier.

VERDICT A $776,000 New York verdict was returned.

Brain injury and cerebral palsy: When did this occur?

DURING LABOR AND DELIVERY, there were periods when the fetal heart-rate tracings were nonreassuring with variable decelerations and fetal tachycardia; some variables were severe. The child suffered anoxic encephalopathy that caused neurologic injury and cerebral palsy.

PARENTS' CLAIM The infant suffered numerous hypoxic incidents before cesarean delivery was performed. An earlier cesarean delivery could have prevented the injury.

PHYSICIAN'S DEFENSE The newborn had a normal blood cord gas level of 7.2 pH and Apgar scores of 9 and 10, at 1 and 5 minutes, respectively. Fetal heart-rate tracings did not show evidence of fetal hypoxia. The brain injury likely occurred prior to the onset of labor and was possibly related to a viral encephalopathy. 

VERDICT A Virginia defense verdict was returned. These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Vaginal hysterectomy has a superior profile in terms of morbidity, safety, and cost, compared with other approaches to hysterectomy for benign disease. Despite this standing, vaginal hysterectomy is performed in a minority of cases. As the rates of other minimally invasive approaches—laparoscopic and robotic—have increased in the United States, the vaginal route has declined from 28% in 1998 to 20% in 2010.^1,2 In fact, a large majority (85%) of gynecologists in the United States perform fewer than five vaginal hysterectomies a year.³

The concept of same-day discharge after hysterectomy is not new. Previously published studies, including one from an author of this study,⁴ have shown that discharging patients 12 to 24 hours after laparoscopic or vaginal hysterectomy is feasible. However, outpatient hysterectomy generally has not been adopted to the same extent as outpatient cholecystectomy in the field of general surgery.

At a time of cost-containment and declining medical reimbursements, outpatient hysterectomy has the potential to affect the health-care economic landscape in a significant manner.

Details of the series
Zakaria and Levy describe a consecutive series of 1,071 women who underwent vaginal hysterectomy (performed by a single surgeon) according to a well-outlined outpatient protocol. Participants underwent preoperative counseling and evidence-based ­interventions (medications, hydration) before, during, and after surgery to preempt postoperative pain and nausea.

Median operative time was 34 minutes (range, 17–210 minutes), and median estimated blood loss was 45 mL (range,5–800 mL). Median uterine weight was 160 g (range, 25–1,380 g).

Following the protocol, same-day discharge (ie, within 12 hours) was accomplished in 96% of patients. A small number (41 women, or approximately 4%) required overnight hospitalization for pain, nausea, or the need to travel a significant distance to return to their home. Five patients required readmission or emergency room evaluation within the first postoperative month due to nausea and vomiting, abdominal pain, fever, pulmonary embolus, or vesicovaginal fistula.

Stengths and limitations
Besides demonstrating that patients can be discharged early, Zakaria and Levy also point out that even traditionally “difficult” vaginal cases—for example, nulliparous women (18% of cases), women with a history of cesarean delivery or pelvic surgery (20% of cases), and patients with uteri larger than 250 g (30% of cases)—can be accomplished vaginally. These cases all were performed using a vessel-sealing device over the 10 years of the series.

Single-surgeon and selection bias may limit the generalizability and conclusions of this study. Future investigations using a comparative cohort (with an inpatient arm) and employing validated measures to evaluate outcomes such as postoperative pain, total narcotic use, return to normal activity, and patient satisfaction, also would be helpful. In addition, it would be beneficial to determine whether the same protocol would be applicable to patients undergoing other hysterectomy approaches. 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Most gynecologic practitioners continue to admit patients overnight following hysterectomy. This study demonstrates that same-day discharge is feasible and safe. It also highlights other routinely employed practices, such as the use of an indwelling catheter and liberal administration of intravenous narcotics postoperatively, that may adversely affect a patient’s recovery.
I strongly recommend that readers refer to this study and consider many of the techniques it describes to minimize postoperative pain and nausea in patients undergoing hysterectomy. Even when a patient is admitted overnight, techniques to minimize postoperative discomfort should be considered.

Vaginal hysterectomy has a superior profile in terms of morbidity, safety, and cost, compared with other approaches to hysterectomy for benign disease. Despite this standing, vaginal hysterectomy is performed in a minority of cases. As the rates of other minimally invasive approaches—laparoscopic and robotic—have increased in the United States, the vaginal route has declined from 28% in 1998 to 20% in 2010.^1,2 In fact, a large majority (85%) of gynecologists in the United States perform fewer than five vaginal hysterectomies a year.³

The concept of same-day discharge after hysterectomy is not new. Previously published studies, including one from an author of this study,⁴ have shown that discharging patients 12 to 24 hours after laparoscopic or vaginal hysterectomy is feasible. However, outpatient hysterectomy generally has not been adopted to the same extent as outpatient cholecystectomy in the field of general surgery.

At a time of cost-containment and declining medical reimbursements, outpatient hysterectomy has the potential to affect the health-care economic landscape in a significant manner.

Details of the series
Zakaria and Levy describe a consecutive series of 1,071 women who underwent vaginal hysterectomy (performed by a single surgeon) according to a well-outlined outpatient protocol. Participants underwent preoperative counseling and evidence-based ­interventions (medications, hydration) before, during, and after surgery to preempt postoperative pain and nausea.

Median operative time was 34 minutes (range, 17–210 minutes), and median estimated blood loss was 45 mL (range,5–800 mL). Median uterine weight was 160 g (range, 25–1,380 g).

Following the protocol, same-day discharge (ie, within 12 hours) was accomplished in 96% of patients. A small number (41 women, or approximately 4%) required overnight hospitalization for pain, nausea, or the need to travel a significant distance to return to their home. Five patients required readmission or emergency room evaluation within the first postoperative month due to nausea and vomiting, abdominal pain, fever, pulmonary embolus, or vesicovaginal fistula.

Stengths and limitations
Besides demonstrating that patients can be discharged early, Zakaria and Levy also point out that even traditionally “difficult” vaginal cases—for example, nulliparous women (18% of cases), women with a history of cesarean delivery or pelvic surgery (20% of cases), and patients with uteri larger than 250 g (30% of cases)—can be accomplished vaginally. These cases all were performed using a vessel-sealing device over the 10 years of the series.

Single-surgeon and selection bias may limit the generalizability and conclusions of this study. Future investigations using a comparative cohort (with an inpatient arm) and employing validated measures to evaluate outcomes such as postoperative pain, total narcotic use, return to normal activity, and patient satisfaction, also would be helpful. In addition, it would be beneficial to determine whether the same protocol would be applicable to patients undergoing other hysterectomy approaches. 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Most gynecologic practitioners continue to admit patients overnight following hysterectomy. This study demonstrates that same-day discharge is feasible and safe. It also highlights other routinely employed practices, such as the use of an indwelling catheter and liberal administration of intravenous narcotics postoperatively, that may adversely affect a patient’s recovery.
I strongly recommend that readers refer to this study and consider many of the techniques it describes to minimize postoperative pain and nausea in patients undergoing hysterectomy. Even when a patient is admitted overnight, techniques to minimize postoperative discomfort should be considered.

Vaginal hysterectomy has a superior profile in terms of morbidity, safety, and cost, compared with other approaches to hysterectomy for benign disease. Despite this standing, vaginal hysterectomy is performed in a minority of cases. As the rates of other minimally invasive approaches—laparoscopic and robotic—have increased in the United States, the vaginal route has declined from 28% in 1998 to 20% in 2010.^1,2 In fact, a large majority (85%) of gynecologists in the United States perform fewer than five vaginal hysterectomies a year.³

The concept of same-day discharge after hysterectomy is not new. Previously published studies, including one from an author of this study,⁴ have shown that discharging patients 12 to 24 hours after laparoscopic or vaginal hysterectomy is feasible. However, outpatient hysterectomy generally has not been adopted to the same extent as outpatient cholecystectomy in the field of general surgery.

At a time of cost-containment and declining medical reimbursements, outpatient hysterectomy has the potential to affect the health-care economic landscape in a significant manner.

Details of the series
Zakaria and Levy describe a consecutive series of 1,071 women who underwent vaginal hysterectomy (performed by a single surgeon) according to a well-outlined outpatient protocol. Participants underwent preoperative counseling and evidence-based ­interventions (medications, hydration) before, during, and after surgery to preempt postoperative pain and nausea.

Median operative time was 34 minutes (range, 17–210 minutes), and median estimated blood loss was 45 mL (range,5–800 mL). Median uterine weight was 160 g (range, 25–1,380 g).

Following the protocol, same-day discharge (ie, within 12 hours) was accomplished in 96% of patients. A small number (41 women, or approximately 4%) required overnight hospitalization for pain, nausea, or the need to travel a significant distance to return to their home. Five patients required readmission or emergency room evaluation within the first postoperative month due to nausea and vomiting, abdominal pain, fever, pulmonary embolus, or vesicovaginal fistula.

Stengths and limitations
Besides demonstrating that patients can be discharged early, Zakaria and Levy also point out that even traditionally “difficult” vaginal cases—for example, nulliparous women (18% of cases), women with a history of cesarean delivery or pelvic surgery (20% of cases), and patients with uteri larger than 250 g (30% of cases)—can be accomplished vaginally. These cases all were performed using a vessel-sealing device over the 10 years of the series.

Single-surgeon and selection bias may limit the generalizability and conclusions of this study. Future investigations using a comparative cohort (with an inpatient arm) and employing validated measures to evaluate outcomes such as postoperative pain, total narcotic use, return to normal activity, and patient satisfaction, also would be helpful. In addition, it would be beneficial to determine whether the same protocol would be applicable to patients undergoing other hysterectomy approaches. 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Most gynecologic practitioners continue to admit patients overnight following hysterectomy. This study demonstrates that same-day discharge is feasible and safe. It also highlights other routinely employed practices, such as the use of an indwelling catheter and liberal administration of intravenous narcotics postoperatively, that may adversely affect a patient’s recovery.
I strongly recommend that readers refer to this study and consider many of the techniques it describes to minimize postoperative pain and nausea in patients undergoing hysterectomy. Even when a patient is admitted overnight, techniques to minimize postoperative discomfort should be considered.

MADRID – Optimizing anti-inflammatory treatment may help to reduce the risk of heart-related problems in men with crystal-proven gout, judging from 7-year follow up data from a prospective study.

Five factors were found to increase substantially the risk for cardiovascular (CV) events in the 251-patient study: including: high levels of C-reactive protein (CRP); renal insufficiency; daily intake of more than 20 g of alcohol; current coronary heart disease (CHD); and a family history of premature CV events.

The odds ratio (OR) for any CV event was 5.71 for CRP levels greater than 5 mg/L on multivariate analysis. This increased to 10.31 and 14.26 when nonfatal and fatal CV events were considered separately.

Odds ratios for renal insufficiency, defined as a creatinine clearance of less than 60 mL/min per 1.73 m², were 4.76 for any CV event and 8.42 for fatal CV events. Respective values for a family history of CV events before the age of 55 years was 3.09 considering any CV event, but 7.53 if consideration was limited to fatal events only. Current CHD also increased the risk for any CV event (OR, 3.67) and for nonfatal events (OR, 10.41).

Alcohol intake of more than 20g/day carried an OR of 4.23 for any CV event.

"We have a cardiologist in our team to ensure the reliability of the cardiovascular outcomes," said Dr. Victoria Barskova of the Research Institute of Rheumatology in Moscow, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72[suppl. 3]:95). She explained that the study was designed to prospectively determine baseline factors that might influence the development of CV events in male patients with crystal-proven gout.

Between 2003 and 2006, a total of 407 men were screened and 301 deemed eligible for the study. Of these, 251 had follow-up data to 2010-2012. Data collected at baseline and at follow-up included patient demographics, including family history of gout and early CV disease, smoking history, and alcohol consumption. Comorbidities and gout characteristics were also assessed and all patients had an ECG and echocardiogram.

Comparing baseline clinical features with follow-up visit data, Dr. Barskova noted that the number of allopurinol users increased from 16% to 57% (P = .00001), although regular allopurinol use was not found to decrease the risk for CV events.

There was an increase in the percentage of patients with diabetes from 18% to 43% (P = .00001), chronic heart disease from 35% to 53% (P = .00001), and heart failure from 10% to 28% (P = .0001). Alcohol use significantly decreased (92% vs. 63%; P less than .0001).

The frequency of subcutaneous tophi and chronic arthritis comparing the first and last visits was the same.

Just under a quarter (23.1%, n = 58) of patients experienced a CV event. There were 32 (13%) deaths reported of which 22 were from cardiovascular causes. There were 36 nonfatal CV events.

"In our cohort of patients with crystal proven gout, the following independent risk factors for all CV events have been highlighted: CRP, renal insufficiency, alcohol intake, coronary heart disease, and a family history of CV events," Dr. Barskova said in conclusion.

The key message for rheumatologists, she added, is that "tight control of inflammation, which is measured not only by the obvious arthritis, but also by the serum CRP level, may have a positive effect on cardiovascular events in patients with gout."

MADRID – Optimizing anti-inflammatory treatment may help to reduce the risk of heart-related problems in men with crystal-proven gout, judging from 7-year follow up data from a prospective study.

Five factors were found to increase substantially the risk for cardiovascular (CV) events in the 251-patient study: including: high levels of C-reactive protein (CRP); renal insufficiency; daily intake of more than 20 g of alcohol; current coronary heart disease (CHD); and a family history of premature CV events.

The odds ratio (OR) for any CV event was 5.71 for CRP levels greater than 5 mg/L on multivariate analysis. This increased to 10.31 and 14.26 when nonfatal and fatal CV events were considered separately.

Odds ratios for renal insufficiency, defined as a creatinine clearance of less than 60 mL/min per 1.73 m², were 4.76 for any CV event and 8.42 for fatal CV events. Respective values for a family history of CV events before the age of 55 years was 3.09 considering any CV event, but 7.53 if consideration was limited to fatal events only. Current CHD also increased the risk for any CV event (OR, 3.67) and for nonfatal events (OR, 10.41).

Alcohol intake of more than 20g/day carried an OR of 4.23 for any CV event.

"We have a cardiologist in our team to ensure the reliability of the cardiovascular outcomes," said Dr. Victoria Barskova of the Research Institute of Rheumatology in Moscow, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72[suppl. 3]:95). She explained that the study was designed to prospectively determine baseline factors that might influence the development of CV events in male patients with crystal-proven gout.

Between 2003 and 2006, a total of 407 men were screened and 301 deemed eligible for the study. Of these, 251 had follow-up data to 2010-2012. Data collected at baseline and at follow-up included patient demographics, including family history of gout and early CV disease, smoking history, and alcohol consumption. Comorbidities and gout characteristics were also assessed and all patients had an ECG and echocardiogram.

Comparing baseline clinical features with follow-up visit data, Dr. Barskova noted that the number of allopurinol users increased from 16% to 57% (P = .00001), although regular allopurinol use was not found to decrease the risk for CV events.

There was an increase in the percentage of patients with diabetes from 18% to 43% (P = .00001), chronic heart disease from 35% to 53% (P = .00001), and heart failure from 10% to 28% (P = .0001). Alcohol use significantly decreased (92% vs. 63%; P less than .0001).

The frequency of subcutaneous tophi and chronic arthritis comparing the first and last visits was the same.

Just under a quarter (23.1%, n = 58) of patients experienced a CV event. There were 32 (13%) deaths reported of which 22 were from cardiovascular causes. There were 36 nonfatal CV events.

"In our cohort of patients with crystal proven gout, the following independent risk factors for all CV events have been highlighted: CRP, renal insufficiency, alcohol intake, coronary heart disease, and a family history of CV events," Dr. Barskova said in conclusion.

The key message for rheumatologists, she added, is that "tight control of inflammation, which is measured not only by the obvious arthritis, but also by the serum CRP level, may have a positive effect on cardiovascular events in patients with gout."

MADRID – Optimizing anti-inflammatory treatment may help to reduce the risk of heart-related problems in men with crystal-proven gout, judging from 7-year follow up data from a prospective study.

Five factors were found to increase substantially the risk for cardiovascular (CV) events in the 251-patient study: including: high levels of C-reactive protein (CRP); renal insufficiency; daily intake of more than 20 g of alcohol; current coronary heart disease (CHD); and a family history of premature CV events.

The odds ratio (OR) for any CV event was 5.71 for CRP levels greater than 5 mg/L on multivariate analysis. This increased to 10.31 and 14.26 when nonfatal and fatal CV events were considered separately.

Odds ratios for renal insufficiency, defined as a creatinine clearance of less than 60 mL/min per 1.73 m², were 4.76 for any CV event and 8.42 for fatal CV events. Respective values for a family history of CV events before the age of 55 years was 3.09 considering any CV event, but 7.53 if consideration was limited to fatal events only. Current CHD also increased the risk for any CV event (OR, 3.67) and for nonfatal events (OR, 10.41).

Alcohol intake of more than 20g/day carried an OR of 4.23 for any CV event.

"We have a cardiologist in our team to ensure the reliability of the cardiovascular outcomes," said Dr. Victoria Barskova of the Research Institute of Rheumatology in Moscow, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72[suppl. 3]:95). She explained that the study was designed to prospectively determine baseline factors that might influence the development of CV events in male patients with crystal-proven gout.

Between 2003 and 2006, a total of 407 men were screened and 301 deemed eligible for the study. Of these, 251 had follow-up data to 2010-2012. Data collected at baseline and at follow-up included patient demographics, including family history of gout and early CV disease, smoking history, and alcohol consumption. Comorbidities and gout characteristics were also assessed and all patients had an ECG and echocardiogram.

Comparing baseline clinical features with follow-up visit data, Dr. Barskova noted that the number of allopurinol users increased from 16% to 57% (P = .00001), although regular allopurinol use was not found to decrease the risk for CV events.

There was an increase in the percentage of patients with diabetes from 18% to 43% (P = .00001), chronic heart disease from 35% to 53% (P = .00001), and heart failure from 10% to 28% (P = .0001). Alcohol use significantly decreased (92% vs. 63%; P less than .0001).

The frequency of subcutaneous tophi and chronic arthritis comparing the first and last visits was the same.

Just under a quarter (23.1%, n = 58) of patients experienced a CV event. There were 32 (13%) deaths reported of which 22 were from cardiovascular causes. There were 36 nonfatal CV events.

"In our cohort of patients with crystal proven gout, the following independent risk factors for all CV events have been highlighted: CRP, renal insufficiency, alcohol intake, coronary heart disease, and a family history of CV events," Dr. Barskova said in conclusion.

The key message for rheumatologists, she added, is that "tight control of inflammation, which is measured not only by the obvious arthritis, but also by the serum CRP level, may have a positive effect on cardiovascular events in patients with gout."

When country singer Ed Bruce released "Mammas, Don’t Let Your Babies Grow Up to be Cowboys" in 1975, he suggested that they should consider becoming doctors instead, but if a new national survey of doctors is to be believed, that’s not such a good career move either.

The survey, conducted by the Georgia-based staffing company Jackson Healthcare, found that 59% of physicians would be unlikely to encourage a young person to become a doctor. The findings are based on the responses of 3,456 physicians who completed e-mailed surveys between March 7 and April 1, 2013.

Mary Ellen Schneider/IMNG Medical Media

Their dissatisfaction with medical practice is reflected in the career satisfaction numbers in the survey. Only 20% of physicians said that they were very satisfied in their work, while 39% were somewhat satisfied and 42% were somewhat or very dissatisfied.

The satisfied ones tended to be those employed by a hospital or working at a physician-owned practice where they had no ownership stake, according to the survey.

Satisfied doctors reported that they worked 11 hours a day or less and were supported by nurse practitioners or physician assistants.

In contrast, dissatisfied doctors tended to own their practices, work as locum tenens physicians, or work for a hospital-owned practice. They also worked longer hours and had few physician extenders.

Maybe the next generation will take Ed Bruce’s other suggested career path and become lawyers.

[email protected]

When country singer Ed Bruce released "Mammas, Don’t Let Your Babies Grow Up to be Cowboys" in 1975, he suggested that they should consider becoming doctors instead, but if a new national survey of doctors is to be believed, that’s not such a good career move either.

The survey, conducted by the Georgia-based staffing company Jackson Healthcare, found that 59% of physicians would be unlikely to encourage a young person to become a doctor. The findings are based on the responses of 3,456 physicians who completed e-mailed surveys between March 7 and April 1, 2013.

Mary Ellen Schneider/IMNG Medical Media

Their dissatisfaction with medical practice is reflected in the career satisfaction numbers in the survey. Only 20% of physicians said that they were very satisfied in their work, while 39% were somewhat satisfied and 42% were somewhat or very dissatisfied.

The satisfied ones tended to be those employed by a hospital or working at a physician-owned practice where they had no ownership stake, according to the survey.

Satisfied doctors reported that they worked 11 hours a day or less and were supported by nurse practitioners or physician assistants.

In contrast, dissatisfied doctors tended to own their practices, work as locum tenens physicians, or work for a hospital-owned practice. They also worked longer hours and had few physician extenders.

Maybe the next generation will take Ed Bruce’s other suggested career path and become lawyers.

[email protected]

When country singer Ed Bruce released "Mammas, Don’t Let Your Babies Grow Up to be Cowboys" in 1975, he suggested that they should consider becoming doctors instead, but if a new national survey of doctors is to be believed, that’s not such a good career move either.

The survey, conducted by the Georgia-based staffing company Jackson Healthcare, found that 59% of physicians would be unlikely to encourage a young person to become a doctor. The findings are based on the responses of 3,456 physicians who completed e-mailed surveys between March 7 and April 1, 2013.

Mary Ellen Schneider/IMNG Medical Media

Their dissatisfaction with medical practice is reflected in the career satisfaction numbers in the survey. Only 20% of physicians said that they were very satisfied in their work, while 39% were somewhat satisfied and 42% were somewhat or very dissatisfied.

The satisfied ones tended to be those employed by a hospital or working at a physician-owned practice where they had no ownership stake, according to the survey.

Satisfied doctors reported that they worked 11 hours a day or less and were supported by nurse practitioners or physician assistants.

In contrast, dissatisfied doctors tended to own their practices, work as locum tenens physicians, or work for a hospital-owned practice. They also worked longer hours and had few physician extenders.

Maybe the next generation will take Ed Bruce’s other suggested career path and become lawyers.

[email protected]

Preparing pills for a clinical trial
Credit: Esther Dyson

Medication mistakes, reporting errors, and record changes are what led the US Food and Drug Administration (FDA) to delay approval of the anticoagulant apixaban (Eliquis), according to a report in Pharmaceutical Approvals Monthly.

The report reveals that a number of patients enrolled on the ARISTOTLE trial received the wrong medication or the wrong dose, some serious adverse events went unreported, and employees who worked at trial sites in China altered records to cover up noncompliance with “good clinical practice.”

Apixaban won FDA approval last December as prophylaxis for stroke and systemic embolism in patients with nonvalvular atrial fibrillation. And that approval was based on results of the ARISTOTLE trial.

Prior to the approval, the FDA twice rejected a new drug application filed by apixaban’s developers, Pfizer and Bristol-Myers Squibb. But the agency’s reasons were not immediately made public.

Now, the Pharmaceutical Approvals Monthly report and FDA documents show that “data irregularities” were behind the decision. 

In January 2012, Bristol-Myers Squibb notified the FDA of the cover-up attempt that occurred at (at least) 1 trial site in China. The company had learned that its senior manager at a site in Shanghai and an employee from a contract research organization had altered source records to conceal good clinical practice violations. (The employees were subsequently fired.)

According to FDA documents, the cover-up included failure to report 4 potential adverse events, late reports on 3 other events, and the omission of 3 patient outcomes. In addition, there were errors in patient names and dates, some Chinese and English records didn’t match up, and some patient records disappeared before a site visit by FDA inspectors.

Only 35 patients enrolled in the ARISTOTLE trial were treated at the Shanghai site, but the employees who perpetrated the fraud had also worked at 24 of the 36 trial sites in China.

So the FDA performed analyses excluding data from the Shanghai site alone, from the 24 sites where the employees worked, and from all 36 sites in China. And they found that apixaban’s efficacy still held up.

However, there was still the issue of ARISTOTLE participants receiving the wrong medication or the wrong dose. According to Bristol-Myers Squibb, the trial’s double-blind design allowed for dispensing errors.

Initially, the company said this meant that 7.3% of patients who were set to receive apixaban and 1.2% of patients who were set to receive warfarin may have received the wrong drug or dose at some point during the study. However, after additional review, the company said those percentages were likely much lower.

Regardless of the actual percentages, the FDA said this information suggests a pattern of inadequate oversight. And an independent review by FDA medical team leader Thomas Marciniak appears to support that statement. In addition to the aforementioned errors, his review revealed records of doctor visits taking place after patients’ deaths.

In spite of the errors and the fraud, the FDA said it remained convinced of apixaban’s efficacy. So the agency decided to approve the drug and leave out any mention of the data irregularities on the drug’s label.

Preparing pills for a clinical trial
Credit: Esther Dyson

Medication mistakes, reporting errors, and record changes are what led the US Food and Drug Administration (FDA) to delay approval of the anticoagulant apixaban (Eliquis), according to a report in Pharmaceutical Approvals Monthly.

The report reveals that a number of patients enrolled on the ARISTOTLE trial received the wrong medication or the wrong dose, some serious adverse events went unreported, and employees who worked at trial sites in China altered records to cover up noncompliance with “good clinical practice.”

Apixaban won FDA approval last December as prophylaxis for stroke and systemic embolism in patients with nonvalvular atrial fibrillation. And that approval was based on results of the ARISTOTLE trial.

Prior to the approval, the FDA twice rejected a new drug application filed by apixaban’s developers, Pfizer and Bristol-Myers Squibb. But the agency’s reasons were not immediately made public.

Now, the Pharmaceutical Approvals Monthly report and FDA documents show that “data irregularities” were behind the decision. 

In January 2012, Bristol-Myers Squibb notified the FDA of the cover-up attempt that occurred at (at least) 1 trial site in China. The company had learned that its senior manager at a site in Shanghai and an employee from a contract research organization had altered source records to conceal good clinical practice violations. (The employees were subsequently fired.)

According to FDA documents, the cover-up included failure to report 4 potential adverse events, late reports on 3 other events, and the omission of 3 patient outcomes. In addition, there were errors in patient names and dates, some Chinese and English records didn’t match up, and some patient records disappeared before a site visit by FDA inspectors.

Only 35 patients enrolled in the ARISTOTLE trial were treated at the Shanghai site, but the employees who perpetrated the fraud had also worked at 24 of the 36 trial sites in China.

So the FDA performed analyses excluding data from the Shanghai site alone, from the 24 sites where the employees worked, and from all 36 sites in China. And they found that apixaban’s efficacy still held up.

However, there was still the issue of ARISTOTLE participants receiving the wrong medication or the wrong dose. According to Bristol-Myers Squibb, the trial’s double-blind design allowed for dispensing errors.

Initially, the company said this meant that 7.3% of patients who were set to receive apixaban and 1.2% of patients who were set to receive warfarin may have received the wrong drug or dose at some point during the study. However, after additional review, the company said those percentages were likely much lower.

Regardless of the actual percentages, the FDA said this information suggests a pattern of inadequate oversight. And an independent review by FDA medical team leader Thomas Marciniak appears to support that statement. In addition to the aforementioned errors, his review revealed records of doctor visits taking place after patients’ deaths.

In spite of the errors and the fraud, the FDA said it remained convinced of apixaban’s efficacy. So the agency decided to approve the drug and leave out any mention of the data irregularities on the drug’s label.

Preparing pills for a clinical trial
Credit: Esther Dyson

Medication mistakes, reporting errors, and record changes are what led the US Food and Drug Administration (FDA) to delay approval of the anticoagulant apixaban (Eliquis), according to a report in Pharmaceutical Approvals Monthly.

The report reveals that a number of patients enrolled on the ARISTOTLE trial received the wrong medication or the wrong dose, some serious adverse events went unreported, and employees who worked at trial sites in China altered records to cover up noncompliance with “good clinical practice.”

Apixaban won FDA approval last December as prophylaxis for stroke and systemic embolism in patients with nonvalvular atrial fibrillation. And that approval was based on results of the ARISTOTLE trial.

Prior to the approval, the FDA twice rejected a new drug application filed by apixaban’s developers, Pfizer and Bristol-Myers Squibb. But the agency’s reasons were not immediately made public.

Now, the Pharmaceutical Approvals Monthly report and FDA documents show that “data irregularities” were behind the decision. 

In January 2012, Bristol-Myers Squibb notified the FDA of the cover-up attempt that occurred at (at least) 1 trial site in China. The company had learned that its senior manager at a site in Shanghai and an employee from a contract research organization had altered source records to conceal good clinical practice violations. (The employees were subsequently fired.)

According to FDA documents, the cover-up included failure to report 4 potential adverse events, late reports on 3 other events, and the omission of 3 patient outcomes. In addition, there were errors in patient names and dates, some Chinese and English records didn’t match up, and some patient records disappeared before a site visit by FDA inspectors.

Only 35 patients enrolled in the ARISTOTLE trial were treated at the Shanghai site, but the employees who perpetrated the fraud had also worked at 24 of the 36 trial sites in China.

So the FDA performed analyses excluding data from the Shanghai site alone, from the 24 sites where the employees worked, and from all 36 sites in China. And they found that apixaban’s efficacy still held up.

However, there was still the issue of ARISTOTLE participants receiving the wrong medication or the wrong dose. According to Bristol-Myers Squibb, the trial’s double-blind design allowed for dispensing errors.

Initially, the company said this meant that 7.3% of patients who were set to receive apixaban and 1.2% of patients who were set to receive warfarin may have received the wrong drug or dose at some point during the study. However, after additional review, the company said those percentages were likely much lower.

Regardless of the actual percentages, the FDA said this information suggests a pattern of inadequate oversight. And an independent review by FDA medical team leader Thomas Marciniak appears to support that statement. In addition to the aforementioned errors, his review revealed records of doctor visits taking place after patients’ deaths.

In spite of the errors and the fraud, the FDA said it remained convinced of apixaban’s efficacy. So the agency decided to approve the drug and leave out any mention of the data irregularities on the drug’s label.

On one of my recent Internet excursions I spent some time on a highly useful website, Hospital Compare. This site is sponsored by Medicare.gov and provides a plethora of useful information for health care consumers who want to know quality metrics on health care facilities in their area. There is quality data on over 4,000 Medicare-certified hospitals across the country.

Hospital Compare is a very user-friendly site. Even those among us who are not so Web savvy can navigate this site in a snap. Just type in your zip code and up pops a list of hospitals in your specified area. You can even narrow your search by requesting what type of hospital you are interested in – acute care Veterans Affairs, acute care, children’s, or critical care access hospitals.

Next, putting a check in the boxes next to hospitals you want to compare produces a grid describing the different facilities. Users can find out which hospitals provide emergency services and whether lab results can be tracked between visits.

Of more interest to hospitalists is the next tab: Patient Survey Results. Here you can find out how well physicians and nurses on your staff communicated with patients during their hospitalization versus how well other health care providers in your region performed.

Courtesy of Medicare.gov

Scrolling through the tabs, you will then find tabs for Timely & Effective Care, which compares inpatient core measures, such as the percentage of patients with MI given aspirin at discharge and the percentage of heart failure patients receiving an ACE inhibitor or an angiotensin receptor blocker. Users can even find out the average wait time in the ED prior to being admitted to a particular hospital.

There is information on how to save money on prescription drugs, advanced directives and long term care, Medicare rights and forms, readmissions, hospital complications, 30-day death rates, health care–associated infections, and much more. While perusing that site, I also came upon yet another great site, Nursing Home Compare. Medicare.gov’s Nursing Home Compareis also chock-full of information for patients and family members who want to find the best care possible. Not only does it rate nursing homes, it gives ratings for rehabilitation facilities as well.

I was shocked to find out that one nursing home near my home had a terrible health inspection rating, while another one close by received flying colors for this metric. This type of information is invaluable for patients who are already sick and vulnerable. This site even provides information about fire safety ratings and details of health inspection reports and complaints.

Patients often ask me what I think about various facilities in the area, and I have had very little valuable information to offer them. It seemed like I always deferred that question to the social worker. Now, I can refer them to this website to help them make very important choices for their health care as well as care for their loved ones.

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS.

On one of my recent Internet excursions I spent some time on a highly useful website, Hospital Compare. This site is sponsored by Medicare.gov and provides a plethora of useful information for health care consumers who want to know quality metrics on health care facilities in their area. There is quality data on over 4,000 Medicare-certified hospitals across the country.

Hospital Compare is a very user-friendly site. Even those among us who are not so Web savvy can navigate this site in a snap. Just type in your zip code and up pops a list of hospitals in your specified area. You can even narrow your search by requesting what type of hospital you are interested in – acute care Veterans Affairs, acute care, children’s, or critical care access hospitals.

Next, putting a check in the boxes next to hospitals you want to compare produces a grid describing the different facilities. Users can find out which hospitals provide emergency services and whether lab results can be tracked between visits.

Of more interest to hospitalists is the next tab: Patient Survey Results. Here you can find out how well physicians and nurses on your staff communicated with patients during their hospitalization versus how well other health care providers in your region performed.

Courtesy of Medicare.gov

Scrolling through the tabs, you will then find tabs for Timely & Effective Care, which compares inpatient core measures, such as the percentage of patients with MI given aspirin at discharge and the percentage of heart failure patients receiving an ACE inhibitor or an angiotensin receptor blocker. Users can even find out the average wait time in the ED prior to being admitted to a particular hospital.

There is information on how to save money on prescription drugs, advanced directives and long term care, Medicare rights and forms, readmissions, hospital complications, 30-day death rates, health care–associated infections, and much more. While perusing that site, I also came upon yet another great site, Nursing Home Compare. Medicare.gov’s Nursing Home Compareis also chock-full of information for patients and family members who want to find the best care possible. Not only does it rate nursing homes, it gives ratings for rehabilitation facilities as well.

I was shocked to find out that one nursing home near my home had a terrible health inspection rating, while another one close by received flying colors for this metric. This type of information is invaluable for patients who are already sick and vulnerable. This site even provides information about fire safety ratings and details of health inspection reports and complaints.

Patients often ask me what I think about various facilities in the area, and I have had very little valuable information to offer them. It seemed like I always deferred that question to the social worker. Now, I can refer them to this website to help them make very important choices for their health care as well as care for their loved ones.

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS.

On one of my recent Internet excursions I spent some time on a highly useful website, Hospital Compare. This site is sponsored by Medicare.gov and provides a plethora of useful information for health care consumers who want to know quality metrics on health care facilities in their area. There is quality data on over 4,000 Medicare-certified hospitals across the country.

Hospital Compare is a very user-friendly site. Even those among us who are not so Web savvy can navigate this site in a snap. Just type in your zip code and up pops a list of hospitals in your specified area. You can even narrow your search by requesting what type of hospital you are interested in – acute care Veterans Affairs, acute care, children’s, or critical care access hospitals.

Next, putting a check in the boxes next to hospitals you want to compare produces a grid describing the different facilities. Users can find out which hospitals provide emergency services and whether lab results can be tracked between visits.

Of more interest to hospitalists is the next tab: Patient Survey Results. Here you can find out how well physicians and nurses on your staff communicated with patients during their hospitalization versus how well other health care providers in your region performed.

Courtesy of Medicare.gov

Scrolling through the tabs, you will then find tabs for Timely & Effective Care, which compares inpatient core measures, such as the percentage of patients with MI given aspirin at discharge and the percentage of heart failure patients receiving an ACE inhibitor or an angiotensin receptor blocker. Users can even find out the average wait time in the ED prior to being admitted to a particular hospital.

There is information on how to save money on prescription drugs, advanced directives and long term care, Medicare rights and forms, readmissions, hospital complications, 30-day death rates, health care–associated infections, and much more. While perusing that site, I also came upon yet another great site, Nursing Home Compare. Medicare.gov’s Nursing Home Compareis also chock-full of information for patients and family members who want to find the best care possible. Not only does it rate nursing homes, it gives ratings for rehabilitation facilities as well.

I was shocked to find out that one nursing home near my home had a terrible health inspection rating, while another one close by received flying colors for this metric. This type of information is invaluable for patients who are already sick and vulnerable. This site even provides information about fire safety ratings and details of health inspection reports and complaints.

Patients often ask me what I think about various facilities in the area, and I have had very little valuable information to offer them. It seemed like I always deferred that question to the social worker. Now, I can refer them to this website to help them make very important choices for their health care as well as care for their loved ones.

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS.

In patients with arterial disease, low baseline diastolic blood pressure may correspond with increased progression of subcortical atrophy, researchers reported online ahead of print June 10 in JAMA Neurology. The association may not depend on subsequent change in blood pressure. Researchers measured blood pressure for 663 participants at baseline and at a mean of 3.9 years later. Change in brain parenchymal fraction, cortical gray matter fraction, and ventricular fraction were quantified as indicators of progression of global, cortical, and subcortical brain atrophy. Patients with lower baseline diastolic blood pressure or mean arterial pressure had more progression of subcortical atrophy. Of patients with higher baseline blood pressure, those with declining blood pressure over time had less progression of subcortical atrophy, compared with those with increasing blood pressure.

Diffusion tensor imaging (DTI) of the basal ganglia and cerebellum may accurately diagnose Parkinson’s disease and other movement disorders, according to a study published online ahead of print May 14 in Movement Disorders. Investigators studied 72 subjects with DTI at 3 T. The technique distinguished between controls and patients with movement disorder with 92% sensitivity and 88% specificity. DTI also distinguished between controls and patients with parkinsonism (93% sensitivity, 91% specificity), Parkinson’s disease and atypical parkinsonism (90% sensitivity, 100% specificity), Parkinson’s disease and multiple system atrophy (94% sensitivity, 100% specificity), Parkinson’s disease and progressive supranuclear palsy (87% sensitivity, 100% specificity), multiple system atrophy and progressive supranuclear palsy (90% sensitivity, 100% specificity), and Parkinson’s disease and essential tremor (92% sensitivity, 87% specificity).

Heading a soccer ball may be associated with abnormal white matter microstructure and poor neurocognitive performance, according to research published online ahead of print June 11 in Radiology. Thirty-seven amateur soccer players answered a questionnaire about heading in the previous 12 months and lifetime history of concussions. Investigators performed diffusion-tensor MRI on the players and evaluated their cognitive function. The players had headed a median of 432 times during the previous year. Heading was associated with lower fractional anisotropy (FA) at three locations in temporo-occipital white matter with a threshold that varied according to location. Heading more than 1,800 times per year was associated with lower levels of FA and poorer memory scores. Concussion history and demographic features were not significantly associated with FA or cognitive performance.

Restless legs syndrome (RLS) may entail an increased risk of mortality, independent of known risk factors, according to a study published online ahead of print June 12 in Neurology. Researchers conducted a prospective cohort study of 18,425 American men without diabetes, arthritis, or renal failure. RLS was assessed using standardized questions. During eight years of follow-up, 2,765 deaths occurred. In an age-adjusted model, RLS was associated with a 39% increased risk of mortality. The association between RLS and mortality was slightly attenuated after further adjustment for BMI, lifestyle factors, chronic conditions, sleep duration, and other sleep-related disorders. When patients with major chronic conditions (eg, cancer, high blood pressure, cardiovascular disease, and other comorbidities) were excluded, the adjusted hazard ratio for RLS was 1.92.

Patients with stroke who are about to undergo surgery can safely continue to take aspirin or warfarin in many instances, according to a guideline published in the May 28 Neurology. Researchers systematically reviewed the literature to assess evidence about the periprocedural management of antithrombotic drugs in patients with ischemic cerebrovascular disease. Stroke patients undergoing dental procedures should routinely continue aspirin, according to the guideline. Stroke patients undergoing invasive ocular anesthesia, cataract surgery, dermatologic procedures, transrectal ultrasound–guided prostate biopsy, spinal or epidural procedures, and carpal tunnel surgery should probably continue aspirin. Stroke patients requiring warfarin should routinely continue it when undergoing dental procedures and probably continue it for dermatologic procedures. Some patients undergoing EMG, prostate procedures, inguinal herniorrhaphy, and endothermal ablation of the great saphenous vein should possibly continue warfarin.

Exposure to pesticides or solvents could be a risk factor for Parkinson’s disease, investigators concluded in the May 28 Neurology. Researchers performed a meta-analysis of prospective cohort and case-control studies that estimated the risk of Parkinson’s disease associated with exposure to pesticides or solvents. Parkinson’s disease was associated with farming, and the association between the disease and pesticides was highly significant in the studies in which Parkinson’s disease diagnosis was self-reported. In high-quality case-control studies, exposure to any pesticides, herbicides, and solvents increased the risk of Parkinson’s disease. Exposure to paraquat or maneb/mancozeb was associated with about a twofold increase in risk. Study quality was not a source of heterogeneity among prospective studies. In case-control studies, study quality was a source of heterogeneity in risk estimates for some exposures.

Atrial fibrillation may be associated with faster cognitive decline, according to a study published online ahead of print June 5 in Neurology. Researchers studied 5,150 men and women 65 or older who did not have atrial fibrillation or a history of stroke at baseline. Atrial fibrillation was identified by examining hospital discharge records and annual ECGs. A total of 552 patients (10.7%) developed incident atrial fibrillation during a mean seven years of follow-up. Mean Modified Mini-Mental State Examination (MMMSE) scores declined faster in patients with incident atrial fibrillation than in patients without atrial fibrillation. The predicted five-year decline in mean MMMSE score from age 80 to age 85 was −6.4 points for participants without atrial fibrillation and −10.3 points for participants with incident atrial fibrillation at age 80.

The level of interleukin 17F (IL-17F) in a patient with relapsing-remitting multiple sclerosis (MS) may not predict his or her response to treatment with interferon beta, according to research published online ahead of print June 3 in JAMA Neurology. Researchers analyzed serum samples from 239 randomly selected patients treated with interferon beta-1b (250 μg) for at least two years. Using clinical and MRI criteria, the investigators found that levels of IL-17F measured at baseline and month six did not correlate with lack of response to treatment after two years. Relapses and new lesions on MRI were not associated with pretreatment serum IL-17F levels. The results did not change when patients with neutralizing antibodies were excluded. Patients with levels of IL-17F higher than 200 pg/mL had poor response and clinical or radiologic activity.

Earlier treatment with thrombolytics may be associated with reduced mortality for patients with stroke, according to data published in the June 19 JAMA. Researchers analyzed data from 58,353 patients with acute ischemic stroke who were treated with t-PA within 4.5 hours of symptom onset in 1,395 hospitals. Patients’ median age was 72, 50.3% of patients were women, and median time to treatment was 144 minutes. A total of 5,142 in-hospital deaths occurred. Faster time to treatment, in 15-minute increments, was associated with reduced in-hospital mortality, reduced symptomatic intracranial hemorrhage, increased achievement of independent ambulation at discharge, and increased discharge to home. Patient factors most strongly associated with shorter time to treatment included greater stroke severity, arrival by ambulance, and arrival during regular hours.

High serum iron levels may be associated with a decreased risk of developing Parkinson’s disease, according to a study published June 4 in PLOS Medicine. Researchers investigated three polymorphisms in the genes HFE and TMPRSS6. For each polymorphism, they performed a meta-analysis of studies investigating the genetic effect on iron levels and a meta-analysis of studies investigating the genetic effect on the risk of Parkinson’s disease. Using three Mendelian randomization analyses, the investigators estimated the effect of iron on Parkinson’s disease for the three polymorphisms. Every 10 µg/dl increase in blood iron corresponded to a 3% reduction in the risk of Parkinson’s disease. Thus, increased blood iron levels may have a protective effect against Parkinson’s disease, but the underlying mechanism remains unclear, said the researchers.

Diabetes and dementia may have a bidirectional association, according to research published online ahead of print June 10 in JAMA Internal Medicine. Investigators examined 783 older adults with diabetes who were participating in a prospective population-based study. Subjects’ mean age was 74, and their baseline Modified Mini-Mental State Examination scores were 80 or higher. Approximately 47% of subjects were African American, and 47% were female. During the 12-year follow-up, 61 participants had a reported hypoglycemic event, and 148 developed dementia. Subjects who had a hypoglycemic event had a twofold increased risk for developing dementia, compared with those who did not have a hypoglycemic event. Subjects with diabetes who developed dementia had a greater risk for having a subsequent hypoglycemic event, compared with participants who did not develop dementia.

Cardiovascular biomarkers may help identify patients with subclinical cerebral injury, according to research published online ahead of print May 9 in Stroke. A total of 1,920 subjects received a brain MRI and had their levels of N-terminal brain natriuretic peptide (NT-proBNP) and cardiac troponin T (hs-cTnT) measured. Of the total group, 1,112 had a follow-up MRI between nine and 13 years later. Individuals with the highest NT-proBNP levels had significantly more silent brain infarcts and white matter lesions on the baseline MRI and more incident silent brain infarcts and white matter lesion progression on the follow-up MRI. Individuals with the highest hs-cTnT levels had more silent brain infarcts and white matter lesions on the initial MRI and more white matter lesion progression on the follow-up MRI.

Stroke symptoms or transient ischemic attack (TIA) may be strongly associated with incident cognitive impairment, researchers concluded in a study published online ahead of print June 19 in Neurology. The investigators studied 23,830 participants without cognitive impairment or history of stroke enrolled in the Reasons for Geographic and Racial Differences in Stroke Study. Subjects reported stroke symptoms and TIA every six months and were screened annually for cognitive impairment. Among Caucasians, the odds ratio for incident cognitive impairment was 2.08 for subjects reporting at least one stroke symptom or TIA, compared with those reporting no stroke symptom or TIA. Among African Americans, the odds ratio was 1.66 using the same modeling. The magnitude of impact was largest among participants with fewer traditional stroke risk factors.

—Erik Greb
Senior Associate Editor

In patients with arterial disease, low baseline diastolic blood pressure may correspond with increased progression of subcortical atrophy, researchers reported online ahead of print June 10 in JAMA Neurology. The association may not depend on subsequent change in blood pressure. Researchers measured blood pressure for 663 participants at baseline and at a mean of 3.9 years later. Change in brain parenchymal fraction, cortical gray matter fraction, and ventricular fraction were quantified as indicators of progression of global, cortical, and subcortical brain atrophy. Patients with lower baseline diastolic blood pressure or mean arterial pressure had more progression of subcortical atrophy. Of patients with higher baseline blood pressure, those with declining blood pressure over time had less progression of subcortical atrophy, compared with those with increasing blood pressure.

Diffusion tensor imaging (DTI) of the basal ganglia and cerebellum may accurately diagnose Parkinson’s disease and other movement disorders, according to a study published online ahead of print May 14 in Movement Disorders. Investigators studied 72 subjects with DTI at 3 T. The technique distinguished between controls and patients with movement disorder with 92% sensitivity and 88% specificity. DTI also distinguished between controls and patients with parkinsonism (93% sensitivity, 91% specificity), Parkinson’s disease and atypical parkinsonism (90% sensitivity, 100% specificity), Parkinson’s disease and multiple system atrophy (94% sensitivity, 100% specificity), Parkinson’s disease and progressive supranuclear palsy (87% sensitivity, 100% specificity), multiple system atrophy and progressive supranuclear palsy (90% sensitivity, 100% specificity), and Parkinson’s disease and essential tremor (92% sensitivity, 87% specificity).

Heading a soccer ball may be associated with abnormal white matter microstructure and poor neurocognitive performance, according to research published online ahead of print June 11 in Radiology. Thirty-seven amateur soccer players answered a questionnaire about heading in the previous 12 months and lifetime history of concussions. Investigators performed diffusion-tensor MRI on the players and evaluated their cognitive function. The players had headed a median of 432 times during the previous year. Heading was associated with lower fractional anisotropy (FA) at three locations in temporo-occipital white matter with a threshold that varied according to location. Heading more than 1,800 times per year was associated with lower levels of FA and poorer memory scores. Concussion history and demographic features were not significantly associated with FA or cognitive performance.

Restless legs syndrome (RLS) may entail an increased risk of mortality, independent of known risk factors, according to a study published online ahead of print June 12 in Neurology. Researchers conducted a prospective cohort study of 18,425 American men without diabetes, arthritis, or renal failure. RLS was assessed using standardized questions. During eight years of follow-up, 2,765 deaths occurred. In an age-adjusted model, RLS was associated with a 39% increased risk of mortality. The association between RLS and mortality was slightly attenuated after further adjustment for BMI, lifestyle factors, chronic conditions, sleep duration, and other sleep-related disorders. When patients with major chronic conditions (eg, cancer, high blood pressure, cardiovascular disease, and other comorbidities) were excluded, the adjusted hazard ratio for RLS was 1.92.

Patients with stroke who are about to undergo surgery can safely continue to take aspirin or warfarin in many instances, according to a guideline published in the May 28 Neurology. Researchers systematically reviewed the literature to assess evidence about the periprocedural management of antithrombotic drugs in patients with ischemic cerebrovascular disease. Stroke patients undergoing dental procedures should routinely continue aspirin, according to the guideline. Stroke patients undergoing invasive ocular anesthesia, cataract surgery, dermatologic procedures, transrectal ultrasound–guided prostate biopsy, spinal or epidural procedures, and carpal tunnel surgery should probably continue aspirin. Stroke patients requiring warfarin should routinely continue it when undergoing dental procedures and probably continue it for dermatologic procedures. Some patients undergoing EMG, prostate procedures, inguinal herniorrhaphy, and endothermal ablation of the great saphenous vein should possibly continue warfarin.

Exposure to pesticides or solvents could be a risk factor for Parkinson’s disease, investigators concluded in the May 28 Neurology. Researchers performed a meta-analysis of prospective cohort and case-control studies that estimated the risk of Parkinson’s disease associated with exposure to pesticides or solvents. Parkinson’s disease was associated with farming, and the association between the disease and pesticides was highly significant in the studies in which Parkinson’s disease diagnosis was self-reported. In high-quality case-control studies, exposure to any pesticides, herbicides, and solvents increased the risk of Parkinson’s disease. Exposure to paraquat or maneb/mancozeb was associated with about a twofold increase in risk. Study quality was not a source of heterogeneity among prospective studies. In case-control studies, study quality was a source of heterogeneity in risk estimates for some exposures.

Atrial fibrillation may be associated with faster cognitive decline, according to a study published online ahead of print June 5 in Neurology. Researchers studied 5,150 men and women 65 or older who did not have atrial fibrillation or a history of stroke at baseline. Atrial fibrillation was identified by examining hospital discharge records and annual ECGs. A total of 552 patients (10.7%) developed incident atrial fibrillation during a mean seven years of follow-up. Mean Modified Mini-Mental State Examination (MMMSE) scores declined faster in patients with incident atrial fibrillation than in patients without atrial fibrillation. The predicted five-year decline in mean MMMSE score from age 80 to age 85 was −6.4 points for participants without atrial fibrillation and −10.3 points for participants with incident atrial fibrillation at age 80.

The level of interleukin 17F (IL-17F) in a patient with relapsing-remitting multiple sclerosis (MS) may not predict his or her response to treatment with interferon beta, according to research published online ahead of print June 3 in JAMA Neurology. Researchers analyzed serum samples from 239 randomly selected patients treated with interferon beta-1b (250 μg) for at least two years. Using clinical and MRI criteria, the investigators found that levels of IL-17F measured at baseline and month six did not correlate with lack of response to treatment after two years. Relapses and new lesions on MRI were not associated with pretreatment serum IL-17F levels. The results did not change when patients with neutralizing antibodies were excluded. Patients with levels of IL-17F higher than 200 pg/mL had poor response and clinical or radiologic activity.

Earlier treatment with thrombolytics may be associated with reduced mortality for patients with stroke, according to data published in the June 19 JAMA. Researchers analyzed data from 58,353 patients with acute ischemic stroke who were treated with t-PA within 4.5 hours of symptom onset in 1,395 hospitals. Patients’ median age was 72, 50.3% of patients were women, and median time to treatment was 144 minutes. A total of 5,142 in-hospital deaths occurred. Faster time to treatment, in 15-minute increments, was associated with reduced in-hospital mortality, reduced symptomatic intracranial hemorrhage, increased achievement of independent ambulation at discharge, and increased discharge to home. Patient factors most strongly associated with shorter time to treatment included greater stroke severity, arrival by ambulance, and arrival during regular hours.

High serum iron levels may be associated with a decreased risk of developing Parkinson’s disease, according to a study published June 4 in PLOS Medicine. Researchers investigated three polymorphisms in the genes HFE and TMPRSS6. For each polymorphism, they performed a meta-analysis of studies investigating the genetic effect on iron levels and a meta-analysis of studies investigating the genetic effect on the risk of Parkinson’s disease. Using three Mendelian randomization analyses, the investigators estimated the effect of iron on Parkinson’s disease for the three polymorphisms. Every 10 µg/dl increase in blood iron corresponded to a 3% reduction in the risk of Parkinson’s disease. Thus, increased blood iron levels may have a protective effect against Parkinson’s disease, but the underlying mechanism remains unclear, said the researchers.

Diabetes and dementia may have a bidirectional association, according to research published online ahead of print June 10 in JAMA Internal Medicine. Investigators examined 783 older adults with diabetes who were participating in a prospective population-based study. Subjects’ mean age was 74, and their baseline Modified Mini-Mental State Examination scores were 80 or higher. Approximately 47% of subjects were African American, and 47% were female. During the 12-year follow-up, 61 participants had a reported hypoglycemic event, and 148 developed dementia. Subjects who had a hypoglycemic event had a twofold increased risk for developing dementia, compared with those who did not have a hypoglycemic event. Subjects with diabetes who developed dementia had a greater risk for having a subsequent hypoglycemic event, compared with participants who did not develop dementia.

Cardiovascular biomarkers may help identify patients with subclinical cerebral injury, according to research published online ahead of print May 9 in Stroke. A total of 1,920 subjects received a brain MRI and had their levels of N-terminal brain natriuretic peptide (NT-proBNP) and cardiac troponin T (hs-cTnT) measured. Of the total group, 1,112 had a follow-up MRI between nine and 13 years later. Individuals with the highest NT-proBNP levels had significantly more silent brain infarcts and white matter lesions on the baseline MRI and more incident silent brain infarcts and white matter lesion progression on the follow-up MRI. Individuals with the highest hs-cTnT levels had more silent brain infarcts and white matter lesions on the initial MRI and more white matter lesion progression on the follow-up MRI.

Stroke symptoms or transient ischemic attack (TIA) may be strongly associated with incident cognitive impairment, researchers concluded in a study published online ahead of print June 19 in Neurology. The investigators studied 23,830 participants without cognitive impairment or history of stroke enrolled in the Reasons for Geographic and Racial Differences in Stroke Study. Subjects reported stroke symptoms and TIA every six months and were screened annually for cognitive impairment. Among Caucasians, the odds ratio for incident cognitive impairment was 2.08 for subjects reporting at least one stroke symptom or TIA, compared with those reporting no stroke symptom or TIA. Among African Americans, the odds ratio was 1.66 using the same modeling. The magnitude of impact was largest among participants with fewer traditional stroke risk factors.

—Erik Greb
Senior Associate Editor

In patients with arterial disease, low baseline diastolic blood pressure may correspond with increased progression of subcortical atrophy, researchers reported online ahead of print June 10 in JAMA Neurology. The association may not depend on subsequent change in blood pressure. Researchers measured blood pressure for 663 participants at baseline and at a mean of 3.9 years later. Change in brain parenchymal fraction, cortical gray matter fraction, and ventricular fraction were quantified as indicators of progression of global, cortical, and subcortical brain atrophy. Patients with lower baseline diastolic blood pressure or mean arterial pressure had more progression of subcortical atrophy. Of patients with higher baseline blood pressure, those with declining blood pressure over time had less progression of subcortical atrophy, compared with those with increasing blood pressure.

Diffusion tensor imaging (DTI) of the basal ganglia and cerebellum may accurately diagnose Parkinson’s disease and other movement disorders, according to a study published online ahead of print May 14 in Movement Disorders. Investigators studied 72 subjects with DTI at 3 T. The technique distinguished between controls and patients with movement disorder with 92% sensitivity and 88% specificity. DTI also distinguished between controls and patients with parkinsonism (93% sensitivity, 91% specificity), Parkinson’s disease and atypical parkinsonism (90% sensitivity, 100% specificity), Parkinson’s disease and multiple system atrophy (94% sensitivity, 100% specificity), Parkinson’s disease and progressive supranuclear palsy (87% sensitivity, 100% specificity), multiple system atrophy and progressive supranuclear palsy (90% sensitivity, 100% specificity), and Parkinson’s disease and essential tremor (92% sensitivity, 87% specificity).

Heading a soccer ball may be associated with abnormal white matter microstructure and poor neurocognitive performance, according to research published online ahead of print June 11 in Radiology. Thirty-seven amateur soccer players answered a questionnaire about heading in the previous 12 months and lifetime history of concussions. Investigators performed diffusion-tensor MRI on the players and evaluated their cognitive function. The players had headed a median of 432 times during the previous year. Heading was associated with lower fractional anisotropy (FA) at three locations in temporo-occipital white matter with a threshold that varied according to location. Heading more than 1,800 times per year was associated with lower levels of FA and poorer memory scores. Concussion history and demographic features were not significantly associated with FA or cognitive performance.

Restless legs syndrome (RLS) may entail an increased risk of mortality, independent of known risk factors, according to a study published online ahead of print June 12 in Neurology. Researchers conducted a prospective cohort study of 18,425 American men without diabetes, arthritis, or renal failure. RLS was assessed using standardized questions. During eight years of follow-up, 2,765 deaths occurred. In an age-adjusted model, RLS was associated with a 39% increased risk of mortality. The association between RLS and mortality was slightly attenuated after further adjustment for BMI, lifestyle factors, chronic conditions, sleep duration, and other sleep-related disorders. When patients with major chronic conditions (eg, cancer, high blood pressure, cardiovascular disease, and other comorbidities) were excluded, the adjusted hazard ratio for RLS was 1.92.

Patients with stroke who are about to undergo surgery can safely continue to take aspirin or warfarin in many instances, according to a guideline published in the May 28 Neurology. Researchers systematically reviewed the literature to assess evidence about the periprocedural management of antithrombotic drugs in patients with ischemic cerebrovascular disease. Stroke patients undergoing dental procedures should routinely continue aspirin, according to the guideline. Stroke patients undergoing invasive ocular anesthesia, cataract surgery, dermatologic procedures, transrectal ultrasound–guided prostate biopsy, spinal or epidural procedures, and carpal tunnel surgery should probably continue aspirin. Stroke patients requiring warfarin should routinely continue it when undergoing dental procedures and probably continue it for dermatologic procedures. Some patients undergoing EMG, prostate procedures, inguinal herniorrhaphy, and endothermal ablation of the great saphenous vein should possibly continue warfarin.

Exposure to pesticides or solvents could be a risk factor for Parkinson’s disease, investigators concluded in the May 28 Neurology. Researchers performed a meta-analysis of prospective cohort and case-control studies that estimated the risk of Parkinson’s disease associated with exposure to pesticides or solvents. Parkinson’s disease was associated with farming, and the association between the disease and pesticides was highly significant in the studies in which Parkinson’s disease diagnosis was self-reported. In high-quality case-control studies, exposure to any pesticides, herbicides, and solvents increased the risk of Parkinson’s disease. Exposure to paraquat or maneb/mancozeb was associated with about a twofold increase in risk. Study quality was not a source of heterogeneity among prospective studies. In case-control studies, study quality was a source of heterogeneity in risk estimates for some exposures.

Atrial fibrillation may be associated with faster cognitive decline, according to a study published online ahead of print June 5 in Neurology. Researchers studied 5,150 men and women 65 or older who did not have atrial fibrillation or a history of stroke at baseline. Atrial fibrillation was identified by examining hospital discharge records and annual ECGs. A total of 552 patients (10.7%) developed incident atrial fibrillation during a mean seven years of follow-up. Mean Modified Mini-Mental State Examination (MMMSE) scores declined faster in patients with incident atrial fibrillation than in patients without atrial fibrillation. The predicted five-year decline in mean MMMSE score from age 80 to age 85 was −6.4 points for participants without atrial fibrillation and −10.3 points for participants with incident atrial fibrillation at age 80.

The level of interleukin 17F (IL-17F) in a patient with relapsing-remitting multiple sclerosis (MS) may not predict his or her response to treatment with interferon beta, according to research published online ahead of print June 3 in JAMA Neurology. Researchers analyzed serum samples from 239 randomly selected patients treated with interferon beta-1b (250 μg) for at least two years. Using clinical and MRI criteria, the investigators found that levels of IL-17F measured at baseline and month six did not correlate with lack of response to treatment after two years. Relapses and new lesions on MRI were not associated with pretreatment serum IL-17F levels. The results did not change when patients with neutralizing antibodies were excluded. Patients with levels of IL-17F higher than 200 pg/mL had poor response and clinical or radiologic activity.

Earlier treatment with thrombolytics may be associated with reduced mortality for patients with stroke, according to data published in the June 19 JAMA. Researchers analyzed data from 58,353 patients with acute ischemic stroke who were treated with t-PA within 4.5 hours of symptom onset in 1,395 hospitals. Patients’ median age was 72, 50.3% of patients were women, and median time to treatment was 144 minutes. A total of 5,142 in-hospital deaths occurred. Faster time to treatment, in 15-minute increments, was associated with reduced in-hospital mortality, reduced symptomatic intracranial hemorrhage, increased achievement of independent ambulation at discharge, and increased discharge to home. Patient factors most strongly associated with shorter time to treatment included greater stroke severity, arrival by ambulance, and arrival during regular hours.

High serum iron levels may be associated with a decreased risk of developing Parkinson’s disease, according to a study published June 4 in PLOS Medicine. Researchers investigated three polymorphisms in the genes HFE and TMPRSS6. For each polymorphism, they performed a meta-analysis of studies investigating the genetic effect on iron levels and a meta-analysis of studies investigating the genetic effect on the risk of Parkinson’s disease. Using three Mendelian randomization analyses, the investigators estimated the effect of iron on Parkinson’s disease for the three polymorphisms. Every 10 µg/dl increase in blood iron corresponded to a 3% reduction in the risk of Parkinson’s disease. Thus, increased blood iron levels may have a protective effect against Parkinson’s disease, but the underlying mechanism remains unclear, said the researchers.

Diabetes and dementia may have a bidirectional association, according to research published online ahead of print June 10 in JAMA Internal Medicine. Investigators examined 783 older adults with diabetes who were participating in a prospective population-based study. Subjects’ mean age was 74, and their baseline Modified Mini-Mental State Examination scores were 80 or higher. Approximately 47% of subjects were African American, and 47% were female. During the 12-year follow-up, 61 participants had a reported hypoglycemic event, and 148 developed dementia. Subjects who had a hypoglycemic event had a twofold increased risk for developing dementia, compared with those who did not have a hypoglycemic event. Subjects with diabetes who developed dementia had a greater risk for having a subsequent hypoglycemic event, compared with participants who did not develop dementia.

Cardiovascular biomarkers may help identify patients with subclinical cerebral injury, according to research published online ahead of print May 9 in Stroke. A total of 1,920 subjects received a brain MRI and had their levels of N-terminal brain natriuretic peptide (NT-proBNP) and cardiac troponin T (hs-cTnT) measured. Of the total group, 1,112 had a follow-up MRI between nine and 13 years later. Individuals with the highest NT-proBNP levels had significantly more silent brain infarcts and white matter lesions on the baseline MRI and more incident silent brain infarcts and white matter lesion progression on the follow-up MRI. Individuals with the highest hs-cTnT levels had more silent brain infarcts and white matter lesions on the initial MRI and more white matter lesion progression on the follow-up MRI.

Stroke symptoms or transient ischemic attack (TIA) may be strongly associated with incident cognitive impairment, researchers concluded in a study published online ahead of print June 19 in Neurology. The investigators studied 23,830 participants without cognitive impairment or history of stroke enrolled in the Reasons for Geographic and Racial Differences in Stroke Study. Subjects reported stroke symptoms and TIA every six months and were screened annually for cognitive impairment. Among Caucasians, the odds ratio for incident cognitive impairment was 2.08 for subjects reporting at least one stroke symptom or TIA, compared with those reporting no stroke symptom or TIA. Among African Americans, the odds ratio was 1.66 using the same modeling. The magnitude of impact was largest among participants with fewer traditional stroke risk factors.

—Erik Greb
Senior Associate Editor