Damian McNamara

NEW ORLEANS — Neonatal and maternal mortality in California did not significantly change after the American College of Obstetricians and Gynecologists recommended that vaginal births be attempted after cesarean delivery only in settings with “immediately available” emergency care, according to one study.

John Zweifler, M.D., and research fellow Susan Hughes compared neonatal and maternal deaths from 1996 to 2002, before and after the 1999 recommendations from the American College of Obstetricians and Gynecologists. They reviewed maternal demographics, birth data, and outcomes, noting previous cesarean sections and whether hospitals were in rural or urban areas.

Very low-birth-weight infants were the only group in the study to experience significantly higher mortality associated with vaginal births after cesarean (VBAC).

When ACOG was contacted for comment, a representative, Gary Hankins, M.D., criticized the study design and its implications.

In 1996, ACOG encouraged VBACs, Dr. Zweifler said at the annual conference of the Society of Teachers of Family Medicine. In 1998, the college changed its recommendations on VBACs and stated they should be attempted only where emergency care is “readily available.”

The following year, ACOG further restricted the recommendations to settings where emergency care is “immediately available.” The college retained the wording of these recommendations in its latest update (Obstet. Gynecol. 2004;104:203–12).

ACOG defines “immediately available” as having access to anesthesia services and a physician throughout active labor, as well as the resources to perform an emergency cesarean. “But for those of us in rural settings, this could impair our ability to do VBAC,” Dr. Zweifler said. “We were concerned that a change in ACOG guidelines would have deleterious effects on our [residency] program.”

California Birth Statistical Master files consider mortality to be associated with birth if it occurs within 72 hours of delivery, explained Dr. Zweifler, program director of the University of California, San Francisco, family medicine residency program, in Fresno.

There were more than 3.5 million single births in California from 1996 to 2002, including 2.7 million vaginal births, 456,000 primary cesarean sections, and 386,000 births by women with a history of cesarean section. Of the women with a history of cesarean delivery, 312,000 had a repeat cesarean, and 74,000 had an attempted VBAC. There were 61,000 successful VBACs and 13,000 failed ones.

VBAC rates decreased from 1996 to 2002, reflecting national trends, Ms. Hughes said. The biggest drop was in rural VBACs.

The study found that “there were very few maternal deaths, about 35. So statistically, there were no differences in maternal mortality between time periods or attempted VBAC, versus repeat cesareans,” Ms. Hughes said. There was a statistically significant increase in mortality for infants weighing less than 1,500 g.

“Attempted VBACs in both time periods had higher death rates than repeat cesareans,” Ms. Hughes added.

However, there were no significant differences in mortality for infants born heavier than 1,500 g, including those heavier than 4,000 g. “You might expect to see [VBAC] complications in the large birth weight group, but we did not see a higher rate,” he said.

Reliability of birth certificate data was a possible limitation of the study, Ms. Hughes said. In addition, there was no information on morbidities, such as uterine rupture or newborn encephalopathy.

“The more restrictive ACOG guidelines have not improved VBAC-related neonatal or maternal mortality,” Dr. Zweifler said. “We feel [that] with previous cesarean, we can expect similar outcomes with either a VBAC or C-section with a normal- or large-birth-weight baby.”

“ACOG's recommendation is purely based on the fact there is no more catastrophic event that befalls women than uterine rupture,” said Dr. Hankins, chair of the ACOG Committee on Obstetric Practice.

“Studies clearly show that if you are not really available to respond to this emergency in a very quick fashion—generally less than 30 minutes—you can expect, in a significant number of cases, either the death of the baby or permanent neurologic injury of the baby from birth asphyxia, said Dr. Hankins, professor in the ob.gyn. department at the University of Texas Medical Branch, Galveston.

NEW ORLEANS — Neonatal and maternal mortality in California did not significantly change after the American College of Obstetricians and Gynecologists recommended that vaginal births be attempted after cesarean delivery only in settings with “immediately available” emergency care, according to one study.

John Zweifler, M.D., and research fellow Susan Hughes compared neonatal and maternal deaths from 1996 to 2002, before and after the 1999 recommendations from the American College of Obstetricians and Gynecologists. They reviewed maternal demographics, birth data, and outcomes, noting previous cesarean sections and whether hospitals were in rural or urban areas.

Very low-birth-weight infants were the only group in the study to experience significantly higher mortality associated with vaginal births after cesarean (VBAC).

When ACOG was contacted for comment, a representative, Gary Hankins, M.D., criticized the study design and its implications.

In 1996, ACOG encouraged VBACs, Dr. Zweifler said at the annual conference of the Society of Teachers of Family Medicine. In 1998, the college changed its recommendations on VBACs and stated they should be attempted only where emergency care is “readily available.”

The following year, ACOG further restricted the recommendations to settings where emergency care is “immediately available.” The college retained the wording of these recommendations in its latest update (Obstet. Gynecol. 2004;104:203–12).

ACOG defines “immediately available” as having access to anesthesia services and a physician throughout active labor, as well as the resources to perform an emergency cesarean. “But for those of us in rural settings, this could impair our ability to do VBAC,” Dr. Zweifler said. “We were concerned that a change in ACOG guidelines would have deleterious effects on our [residency] program.”

California Birth Statistical Master files consider mortality to be associated with birth if it occurs within 72 hours of delivery, explained Dr. Zweifler, program director of the University of California, San Francisco, family medicine residency program, in Fresno.

There were more than 3.5 million single births in California from 1996 to 2002, including 2.7 million vaginal births, 456,000 primary cesarean sections, and 386,000 births by women with a history of cesarean section. Of the women with a history of cesarean delivery, 312,000 had a repeat cesarean, and 74,000 had an attempted VBAC. There were 61,000 successful VBACs and 13,000 failed ones.

VBAC rates decreased from 1996 to 2002, reflecting national trends, Ms. Hughes said. The biggest drop was in rural VBACs.

The study found that “there were very few maternal deaths, about 35. So statistically, there were no differences in maternal mortality between time periods or attempted VBAC, versus repeat cesareans,” Ms. Hughes said. There was a statistically significant increase in mortality for infants weighing less than 1,500 g.

“Attempted VBACs in both time periods had higher death rates than repeat cesareans,” Ms. Hughes added.

However, there were no significant differences in mortality for infants born heavier than 1,500 g, including those heavier than 4,000 g. “You might expect to see [VBAC] complications in the large birth weight group, but we did not see a higher rate,” he said.

Reliability of birth certificate data was a possible limitation of the study, Ms. Hughes said. In addition, there was no information on morbidities, such as uterine rupture or newborn encephalopathy.

“The more restrictive ACOG guidelines have not improved VBAC-related neonatal or maternal mortality,” Dr. Zweifler said. “We feel [that] with previous cesarean, we can expect similar outcomes with either a VBAC or C-section with a normal- or large-birth-weight baby.”

“ACOG's recommendation is purely based on the fact there is no more catastrophic event that befalls women than uterine rupture,” said Dr. Hankins, chair of the ACOG Committee on Obstetric Practice.

“Studies clearly show that if you are not really available to respond to this emergency in a very quick fashion—generally less than 30 minutes—you can expect, in a significant number of cases, either the death of the baby or permanent neurologic injury of the baby from birth asphyxia, said Dr. Hankins, professor in the ob.gyn. department at the University of Texas Medical Branch, Galveston.

NEW ORLEANS — Neonatal and maternal mortality in California did not significantly change after the American College of Obstetricians and Gynecologists recommended that vaginal births be attempted after cesarean delivery only in settings with “immediately available” emergency care, according to one study.

John Zweifler, M.D., and research fellow Susan Hughes compared neonatal and maternal deaths from 1996 to 2002, before and after the 1999 recommendations from the American College of Obstetricians and Gynecologists. They reviewed maternal demographics, birth data, and outcomes, noting previous cesarean sections and whether hospitals were in rural or urban areas.

Very low-birth-weight infants were the only group in the study to experience significantly higher mortality associated with vaginal births after cesarean (VBAC).

When ACOG was contacted for comment, a representative, Gary Hankins, M.D., criticized the study design and its implications.

In 1996, ACOG encouraged VBACs, Dr. Zweifler said at the annual conference of the Society of Teachers of Family Medicine. In 1998, the college changed its recommendations on VBACs and stated they should be attempted only where emergency care is “readily available.”

The following year, ACOG further restricted the recommendations to settings where emergency care is “immediately available.” The college retained the wording of these recommendations in its latest update (Obstet. Gynecol. 2004;104:203–12).

ACOG defines “immediately available” as having access to anesthesia services and a physician throughout active labor, as well as the resources to perform an emergency cesarean. “But for those of us in rural settings, this could impair our ability to do VBAC,” Dr. Zweifler said. “We were concerned that a change in ACOG guidelines would have deleterious effects on our [residency] program.”

California Birth Statistical Master files consider mortality to be associated with birth if it occurs within 72 hours of delivery, explained Dr. Zweifler, program director of the University of California, San Francisco, family medicine residency program, in Fresno.

There were more than 3.5 million single births in California from 1996 to 2002, including 2.7 million vaginal births, 456,000 primary cesarean sections, and 386,000 births by women with a history of cesarean section. Of the women with a history of cesarean delivery, 312,000 had a repeat cesarean, and 74,000 had an attempted VBAC. There were 61,000 successful VBACs and 13,000 failed ones.

VBAC rates decreased from 1996 to 2002, reflecting national trends, Ms. Hughes said. The biggest drop was in rural VBACs.

The study found that “there were very few maternal deaths, about 35. So statistically, there were no differences in maternal mortality between time periods or attempted VBAC, versus repeat cesareans,” Ms. Hughes said. There was a statistically significant increase in mortality for infants weighing less than 1,500 g.

“Attempted VBACs in both time periods had higher death rates than repeat cesareans,” Ms. Hughes added.

However, there were no significant differences in mortality for infants born heavier than 1,500 g, including those heavier than 4,000 g. “You might expect to see [VBAC] complications in the large birth weight group, but we did not see a higher rate,” he said.

Reliability of birth certificate data was a possible limitation of the study, Ms. Hughes said. In addition, there was no information on morbidities, such as uterine rupture or newborn encephalopathy.

“The more restrictive ACOG guidelines have not improved VBAC-related neonatal or maternal mortality,” Dr. Zweifler said. “We feel [that] with previous cesarean, we can expect similar outcomes with either a VBAC or C-section with a normal- or large-birth-weight baby.”

“ACOG's recommendation is purely based on the fact there is no more catastrophic event that befalls women than uterine rupture,” said Dr. Hankins, chair of the ACOG Committee on Obstetric Practice.

“Studies clearly show that if you are not really available to respond to this emergency in a very quick fashion—generally less than 30 minutes—you can expect, in a significant number of cases, either the death of the baby or permanent neurologic injury of the baby from birth asphyxia, said Dr. Hankins, professor in the ob.gyn. department at the University of Texas Medical Branch, Galveston.

NEW ORLEANS — Low-income smokers prescribed bupropion in primary care settings are less successful with smoking cessation than participants in controlled trials, according to a study presented at the annual conference of the Society of Teachers of Family Medicine.

Multicenter trials indicate that sustained-release bupropion helps 44% quit at 7 weeks, compared with 19% taking a placebo (N. Engl. J. Med. 1997; 337:1195–202) and 58% of cigarette smokers quit at 9 weeks, compared with 16% taking a placebo (N. Engl. J. Med. 1999;340:685–91).

But participants in those bupropion trials did not reflect the patient population in Fresno County, according to Evelyn Fang, M.D. The county has a 23% poverty rate (vs. 14% for California), a high rate of stroke and heart disease, and an increasing rate of lung cancer deaths.

Physicians at one family medicine clinic and two internal medicine clinics associated with the University of California, San Francisco, Fresno campus, screened and referred patients to Dr. Fang and her associates. The researchers enrolled 72 participants over 3 months from the University of California, San Francisco, Fresno residency-affiliated training sites.

Dr. Fang, who is no longer with the university, was a clinical instructor in medicine when the study was conducted. John Zweifler, M.D., also of the University of California, San Francisco, Fresno, presented the study at the meeting.

Participants received a free 30-day supply of bupropion with one refill. They took one pill every day for 3 days, then increased to two pills daily, and were advised to stop smoking after 7 days.

The researchers surveyed participants by telephone at 30 days and 60 days. A total of 57 patients completed the follow-up and were studied further.

The mean age was 47 years and 65% were female. The group was 61% Caucasian, 19% Hispanic, 18% African American, and 2% Asian.

Participants reported a median of two previous attempts to quit smoking and a median of 30 years of cigarette smoking. A total of 17% stopped smoking at 3 months, as did 18% at 6 months.

Sustained-release bupropion may help low-income smokers in real clinical settings quit smoking, Dr. Zweifler, M.D., said, but the effect was less than half of what has been previously reported in highly controlled trials of more motivated patients.

Limitations of the study include the sample size and the lack of a control group.

NEW ORLEANS — Low-income smokers prescribed bupropion in primary care settings are less successful with smoking cessation than participants in controlled trials, according to a study presented at the annual conference of the Society of Teachers of Family Medicine.

Multicenter trials indicate that sustained-release bupropion helps 44% quit at 7 weeks, compared with 19% taking a placebo (N. Engl. J. Med. 1997; 337:1195–202) and 58% of cigarette smokers quit at 9 weeks, compared with 16% taking a placebo (N. Engl. J. Med. 1999;340:685–91).

But participants in those bupropion trials did not reflect the patient population in Fresno County, according to Evelyn Fang, M.D. The county has a 23% poverty rate (vs. 14% for California), a high rate of stroke and heart disease, and an increasing rate of lung cancer deaths.

Physicians at one family medicine clinic and two internal medicine clinics associated with the University of California, San Francisco, Fresno campus, screened and referred patients to Dr. Fang and her associates. The researchers enrolled 72 participants over 3 months from the University of California, San Francisco, Fresno residency-affiliated training sites.

Dr. Fang, who is no longer with the university, was a clinical instructor in medicine when the study was conducted. John Zweifler, M.D., also of the University of California, San Francisco, Fresno, presented the study at the meeting.

Participants received a free 30-day supply of bupropion with one refill. They took one pill every day for 3 days, then increased to two pills daily, and were advised to stop smoking after 7 days.

The researchers surveyed participants by telephone at 30 days and 60 days. A total of 57 patients completed the follow-up and were studied further.

The mean age was 47 years and 65% were female. The group was 61% Caucasian, 19% Hispanic, 18% African American, and 2% Asian.

Participants reported a median of two previous attempts to quit smoking and a median of 30 years of cigarette smoking. A total of 17% stopped smoking at 3 months, as did 18% at 6 months.

Sustained-release bupropion may help low-income smokers in real clinical settings quit smoking, Dr. Zweifler, M.D., said, but the effect was less than half of what has been previously reported in highly controlled trials of more motivated patients.

Limitations of the study include the sample size and the lack of a control group.

NEW ORLEANS — Low-income smokers prescribed bupropion in primary care settings are less successful with smoking cessation than participants in controlled trials, according to a study presented at the annual conference of the Society of Teachers of Family Medicine.

Multicenter trials indicate that sustained-release bupropion helps 44% quit at 7 weeks, compared with 19% taking a placebo (N. Engl. J. Med. 1997; 337:1195–202) and 58% of cigarette smokers quit at 9 weeks, compared with 16% taking a placebo (N. Engl. J. Med. 1999;340:685–91).

But participants in those bupropion trials did not reflect the patient population in Fresno County, according to Evelyn Fang, M.D. The county has a 23% poverty rate (vs. 14% for California), a high rate of stroke and heart disease, and an increasing rate of lung cancer deaths.

Physicians at one family medicine clinic and two internal medicine clinics associated with the University of California, San Francisco, Fresno campus, screened and referred patients to Dr. Fang and her associates. The researchers enrolled 72 participants over 3 months from the University of California, San Francisco, Fresno residency-affiliated training sites.

Dr. Fang, who is no longer with the university, was a clinical instructor in medicine when the study was conducted. John Zweifler, M.D., also of the University of California, San Francisco, Fresno, presented the study at the meeting.

Participants received a free 30-day supply of bupropion with one refill. They took one pill every day for 3 days, then increased to two pills daily, and were advised to stop smoking after 7 days.

The researchers surveyed participants by telephone at 30 days and 60 days. A total of 57 patients completed the follow-up and were studied further.

The mean age was 47 years and 65% were female. The group was 61% Caucasian, 19% Hispanic, 18% African American, and 2% Asian.

Participants reported a median of two previous attempts to quit smoking and a median of 30 years of cigarette smoking. A total of 17% stopped smoking at 3 months, as did 18% at 6 months.

Sustained-release bupropion may help low-income smokers in real clinical settings quit smoking, Dr. Zweifler, M.D., said, but the effect was less than half of what has been previously reported in highly controlled trials of more motivated patients.

Limitations of the study include the sample size and the lack of a control group.

MIAMI BEACH – Some antiepileptic drugs cause more sedation than do others, according to a study presented at the annual meeting of the American Academy of Neurology.

Sedation is a common side effect of antiepileptic drugs (AEDs). However, the relative prevalence of sedation associated with each AED is unknown, David B. Weintraub said.

Mr. Weintraub and his associates performed a head-to-head comparison of epilepsy drugs commonly used at the Columbia Comprehensive Epilepsy Center at New York-Presbyterian Hospital in New York City, where he is a research coordinator.

Researchers reviewed charts for 1,088 adult patients treated at the center since January 2001. They assessed the overall rate of sedation attributed to a particular AED and whether sedation led to drug discontinuation.

They also looked at subpopulations taking an AED as monotherapy and patients beginning a particular agent, or “new starts.” In each comparison, the drug was compared with the average rate of sedation of all other agents using chi-square analysis.

Investigators reviewed the Columbia AED database for patients' background, medical history, and AED use, including AED efficacy and side effects.

In addition, the investigators recorded all physician or patient reports of sedation or sleepiness, tiredness, lethargy, drowsiness, or fatigue associated with an AED.

Overall, 34% of the participants experienced sedation from one or more AEDs. An average of 15% of patients starting a new AED experienced sedation. In almost 5% of participants, the sedation was cited as a reason the patient discontinued the drug.

Elan, GlaxoSmithKline, Pfizer, Ortho-McNeill, and UCB Pharma provide funding for the Columbia AED database. Mr. Weintraub has received financial support from UCB Pharma.

The incidence of both sedation and drug discontinuation were highest among patients taking phenobarbital (39% and 15%, respectively). Phenytoin had a higher than average incidence of sedation (32%), as did levetiracetam (20%), but discontinuation rates among patients taking these drugs were average.

“Phenytoin and levetiracetam were the only ones that reached statistical significance for increasing sedation,” coauthor and presenter Lawrence J. Hirsch, M.D., said. (The 13 patients taking phenobarbital in the study were too few to reach statistical significance.)

Dr. Hirsch, of the department of neurology at Columbia University, has received personal compensation from Elan, GlaxoSmithKline, Ortho-McNeil, and UCB Pharma; he has also received financial support from these four companies as well as from Pfizer.

Intermediate rates of sedation were associated with oxcarbazepine (17%), zonisamide (16%), topiramate (14%), carbamazepine (13%), clobazam (13%), and valproic acid (11%).

The researchers found that lamotrigine (10%) and gabapentin (9%) had the lowest consistent sedating effects in the study.

The investigators also looked at the 254 patients taking an AED as monotherapy. The average rate of sedation was 21% in this subpopulation.

“These were smaller numbers,” Dr. Hirsch said. “Nothing reached statistical significance here.”

MIAMI BEACH – Some antiepileptic drugs cause more sedation than do others, according to a study presented at the annual meeting of the American Academy of Neurology.

Sedation is a common side effect of antiepileptic drugs (AEDs). However, the relative prevalence of sedation associated with each AED is unknown, David B. Weintraub said.

Mr. Weintraub and his associates performed a head-to-head comparison of epilepsy drugs commonly used at the Columbia Comprehensive Epilepsy Center at New York-Presbyterian Hospital in New York City, where he is a research coordinator.

Researchers reviewed charts for 1,088 adult patients treated at the center since January 2001. They assessed the overall rate of sedation attributed to a particular AED and whether sedation led to drug discontinuation.

They also looked at subpopulations taking an AED as monotherapy and patients beginning a particular agent, or “new starts.” In each comparison, the drug was compared with the average rate of sedation of all other agents using chi-square analysis.

Investigators reviewed the Columbia AED database for patients' background, medical history, and AED use, including AED efficacy and side effects.

In addition, the investigators recorded all physician or patient reports of sedation or sleepiness, tiredness, lethargy, drowsiness, or fatigue associated with an AED.

Overall, 34% of the participants experienced sedation from one or more AEDs. An average of 15% of patients starting a new AED experienced sedation. In almost 5% of participants, the sedation was cited as a reason the patient discontinued the drug.

Elan, GlaxoSmithKline, Pfizer, Ortho-McNeill, and UCB Pharma provide funding for the Columbia AED database. Mr. Weintraub has received financial support from UCB Pharma.

The incidence of both sedation and drug discontinuation were highest among patients taking phenobarbital (39% and 15%, respectively). Phenytoin had a higher than average incidence of sedation (32%), as did levetiracetam (20%), but discontinuation rates among patients taking these drugs were average.

“Phenytoin and levetiracetam were the only ones that reached statistical significance for increasing sedation,” coauthor and presenter Lawrence J. Hirsch, M.D., said. (The 13 patients taking phenobarbital in the study were too few to reach statistical significance.)

Dr. Hirsch, of the department of neurology at Columbia University, has received personal compensation from Elan, GlaxoSmithKline, Ortho-McNeil, and UCB Pharma; he has also received financial support from these four companies as well as from Pfizer.

Intermediate rates of sedation were associated with oxcarbazepine (17%), zonisamide (16%), topiramate (14%), carbamazepine (13%), clobazam (13%), and valproic acid (11%).

The researchers found that lamotrigine (10%) and gabapentin (9%) had the lowest consistent sedating effects in the study.

The investigators also looked at the 254 patients taking an AED as monotherapy. The average rate of sedation was 21% in this subpopulation.

“These were smaller numbers,” Dr. Hirsch said. “Nothing reached statistical significance here.”

MIAMI BEACH – Some antiepileptic drugs cause more sedation than do others, according to a study presented at the annual meeting of the American Academy of Neurology.

Sedation is a common side effect of antiepileptic drugs (AEDs). However, the relative prevalence of sedation associated with each AED is unknown, David B. Weintraub said.

Mr. Weintraub and his associates performed a head-to-head comparison of epilepsy drugs commonly used at the Columbia Comprehensive Epilepsy Center at New York-Presbyterian Hospital in New York City, where he is a research coordinator.

Researchers reviewed charts for 1,088 adult patients treated at the center since January 2001. They assessed the overall rate of sedation attributed to a particular AED and whether sedation led to drug discontinuation.

They also looked at subpopulations taking an AED as monotherapy and patients beginning a particular agent, or “new starts.” In each comparison, the drug was compared with the average rate of sedation of all other agents using chi-square analysis.

Investigators reviewed the Columbia AED database for patients' background, medical history, and AED use, including AED efficacy and side effects.

In addition, the investigators recorded all physician or patient reports of sedation or sleepiness, tiredness, lethargy, drowsiness, or fatigue associated with an AED.

Overall, 34% of the participants experienced sedation from one or more AEDs. An average of 15% of patients starting a new AED experienced sedation. In almost 5% of participants, the sedation was cited as a reason the patient discontinued the drug.

Elan, GlaxoSmithKline, Pfizer, Ortho-McNeill, and UCB Pharma provide funding for the Columbia AED database. Mr. Weintraub has received financial support from UCB Pharma.

The incidence of both sedation and drug discontinuation were highest among patients taking phenobarbital (39% and 15%, respectively). Phenytoin had a higher than average incidence of sedation (32%), as did levetiracetam (20%), but discontinuation rates among patients taking these drugs were average.

“Phenytoin and levetiracetam were the only ones that reached statistical significance for increasing sedation,” coauthor and presenter Lawrence J. Hirsch, M.D., said. (The 13 patients taking phenobarbital in the study were too few to reach statistical significance.)

Dr. Hirsch, of the department of neurology at Columbia University, has received personal compensation from Elan, GlaxoSmithKline, Ortho-McNeil, and UCB Pharma; he has also received financial support from these four companies as well as from Pfizer.

Intermediate rates of sedation were associated with oxcarbazepine (17%), zonisamide (16%), topiramate (14%), carbamazepine (13%), clobazam (13%), and valproic acid (11%).

The researchers found that lamotrigine (10%) and gabapentin (9%) had the lowest consistent sedating effects in the study.

The investigators also looked at the 254 patients taking an AED as monotherapy. The average rate of sedation was 21% in this subpopulation.

“These were smaller numbers,” Dr. Hirsch said. “Nothing reached statistical significance here.”

NEW ORLEANS — Electronic health records did not improve physician adherence to evidence-based diabetes guidelines in a study of primary care practices.

The 37 practices without electronic health records (EHRs) provided equal or better diabetes care than the 17 with the technology, “but there is much room for improvement in both groups,” Jesse C. Crosson, Ph.D., said at the annual conference of the Society of Teachers of Family Medicine.

Information technology is recommended to improve quality of care, but EHR capabilities are unevenly used in primary care. Successful integration of EHRs depend on organizational factors and how well physicians communicate with each other, said Dr. Crosson of the department of family medicine at New Jersey Medical School, Newark.

Practices strongly oriented toward patient care, characterized by relatively open scheduling and physicians who are easy to contact, are more likely to optimize use of EHRs. Practices with a greater focus on money and the bottom line, and with longer wait times for patients, tend to integrate EHRs less well, he said.

The researchers focused on type 2 diabetes because clinical care is complex and treatment guidelines are interrelated, Dr. Crosson said. He and his associates reviewed the charts of 1,080 randomly selected diabetes patients—20 patients each from 54 primary care practices in New Jersey and Pennsylvania. There were no significant differences between EHR and non-EHR practices in terms of number of physicians, number of exam rooms, years in practice, or type of practice.

There were no statistically significant differences in diabetes management between practices with or without EHRs. In multivariate analyses, nonEHR practices did better in assessment, medication management, and outcome targets. The targets were LDL cholesterol below 100 mg/dL, hemoglobin A1c below 7%, and blood pressure below 130/85 mm Hg.

All practices in the study could do better regarding diabetes assessment, Dr. Crosson said. Overall, 52% of participants met three out of these five criteria:

▸ HbA1c tested in the last 6 months.

▸ Microalbumin tested in last 12 months.

▸ Smoking assessment documented.

▸ LDL cholesterol tested in last 12 months.

▸ Blood pressure assessed at every visit.

The study was retrospective, so there could have been selection biases. Also, “we were really limited to what was in the medical record. We do not have income, race, or insurance status,” he said.

NEW ORLEANS — Electronic health records did not improve physician adherence to evidence-based diabetes guidelines in a study of primary care practices.

The 37 practices without electronic health records (EHRs) provided equal or better diabetes care than the 17 with the technology, “but there is much room for improvement in both groups,” Jesse C. Crosson, Ph.D., said at the annual conference of the Society of Teachers of Family Medicine.

Information technology is recommended to improve quality of care, but EHR capabilities are unevenly used in primary care. Successful integration of EHRs depend on organizational factors and how well physicians communicate with each other, said Dr. Crosson of the department of family medicine at New Jersey Medical School, Newark.

Practices strongly oriented toward patient care, characterized by relatively open scheduling and physicians who are easy to contact, are more likely to optimize use of EHRs. Practices with a greater focus on money and the bottom line, and with longer wait times for patients, tend to integrate EHRs less well, he said.

The researchers focused on type 2 diabetes because clinical care is complex and treatment guidelines are interrelated, Dr. Crosson said. He and his associates reviewed the charts of 1,080 randomly selected diabetes patients—20 patients each from 54 primary care practices in New Jersey and Pennsylvania. There were no significant differences between EHR and non-EHR practices in terms of number of physicians, number of exam rooms, years in practice, or type of practice.

There were no statistically significant differences in diabetes management between practices with or without EHRs. In multivariate analyses, nonEHR practices did better in assessment, medication management, and outcome targets. The targets were LDL cholesterol below 100 mg/dL, hemoglobin A1c below 7%, and blood pressure below 130/85 mm Hg.

All practices in the study could do better regarding diabetes assessment, Dr. Crosson said. Overall, 52% of participants met three out of these five criteria:

▸ HbA1c tested in the last 6 months.

▸ Microalbumin tested in last 12 months.

▸ Smoking assessment documented.

▸ LDL cholesterol tested in last 12 months.

▸ Blood pressure assessed at every visit.

The study was retrospective, so there could have been selection biases. Also, “we were really limited to what was in the medical record. We do not have income, race, or insurance status,” he said.

NEW ORLEANS — Electronic health records did not improve physician adherence to evidence-based diabetes guidelines in a study of primary care practices.

The 37 practices without electronic health records (EHRs) provided equal or better diabetes care than the 17 with the technology, “but there is much room for improvement in both groups,” Jesse C. Crosson, Ph.D., said at the annual conference of the Society of Teachers of Family Medicine.

Information technology is recommended to improve quality of care, but EHR capabilities are unevenly used in primary care. Successful integration of EHRs depend on organizational factors and how well physicians communicate with each other, said Dr. Crosson of the department of family medicine at New Jersey Medical School, Newark.

Practices strongly oriented toward patient care, characterized by relatively open scheduling and physicians who are easy to contact, are more likely to optimize use of EHRs. Practices with a greater focus on money and the bottom line, and with longer wait times for patients, tend to integrate EHRs less well, he said.

The researchers focused on type 2 diabetes because clinical care is complex and treatment guidelines are interrelated, Dr. Crosson said. He and his associates reviewed the charts of 1,080 randomly selected diabetes patients—20 patients each from 54 primary care practices in New Jersey and Pennsylvania. There were no significant differences between EHR and non-EHR practices in terms of number of physicians, number of exam rooms, years in practice, or type of practice.

There were no statistically significant differences in diabetes management between practices with or without EHRs. In multivariate analyses, nonEHR practices did better in assessment, medication management, and outcome targets. The targets were LDL cholesterol below 100 mg/dL, hemoglobin A1c below 7%, and blood pressure below 130/85 mm Hg.

All practices in the study could do better regarding diabetes assessment, Dr. Crosson said. Overall, 52% of participants met three out of these five criteria:

▸ HbA1c tested in the last 6 months.

▸ Microalbumin tested in last 12 months.

▸ Smoking assessment documented.

▸ LDL cholesterol tested in last 12 months.

▸ Blood pressure assessed at every visit.

The study was retrospective, so there could have been selection biases. Also, “we were really limited to what was in the medical record. We do not have income, race, or insurance status,” he said.

MIAMI BEACH — There are many options for antibiotic treatment of uncomplicated and complicated skin infections, each with its own advantages and disadvantages, according to a presentation by Richard K. Scher, M.D., at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

Major goals of therapy include prompt eradication of the infection, reduction of potential antibiotic resistance, and lower risk of recurrence. Safety, efficacy, cost, compliance, managed care formularies, and community-acquired methicillin-resistant Staphylococcus aureus (MRSA) are important considerations when individualizing therapy, according to Dr. Scher, professor of clinical dermatology at Columbia University, New York.

Uncomplicated infections affect superficial skin tissue and include furuncles, cellulites, folliculitis, simple abscesses, and impetiginous lesions. Complicated infections affect deeper soft tissue or require significant surgery, such as infected ulcers, burns, or major abscesses. Infections are also complicated in the presence of significant underlying disease or if the affected site carries a higher risk for anaerobic or gram-negative infection, such as the rectal area.

Severe atopic dermatitis, poorly controlled diabetes, and patients with kidney failure may be predisposed to skin infections. Other risk factors are leukemia or lymphoma; malnutrition and low serum iron; alcohol abuse; intravenous drug use; and medications including systemic steroids, retinoids, cytotoxic agents, and immunosuppressants.

Dr. Scher discussed these options for treating skin structure infections:

▸ Cephalosporins. These drugs have good tolerability and good sensitivity. The risk of hypersensitivity is low, probably less than 2%, for a patient with a history of nonanaphylactic penicillin allergy.

First-generation drugs in this class include cephalexin and cefadroxil. They have good activity against S. pyogenes and MRSA. Dosing is t.i.d. to q.i.d.

Second-generation cephalosporins include cefaclor and cefuroxime, which have expanded activity against gram-negative bacteria and a longer half-life than the first-generation drugs. Dosing is b.i.d.

Third-generation agents include cefixime and ceftibuten. They are good for gram-negative organisms but not as good for gram-positive bacteria, Dr. Scher noted. Dosing is once daily or b.i.d.

Extended-spectrum cephalosporins include cefdinir and cefpodoxime, which are active against gram-negative and gram-positive bacteria. Cefdinir is administered b.i.d.

▸ Penicillins. S. pyogenes is always sensitive to treatment with penicillins, but because of cross resistance from MRSA, S. aureus is no longer sensitive. Drugs in this class that are β-lactamase stable exhibit good antistaphylococcal activity. Most dosing is t.i.d. or q.i.d.

▸ Macrolides. These drugs include erythromycin, clarithromycin, and azithromycin. They are less likely to be used because of concerns about resistance, Dr. Scher said. Increasing resistance to S. pyogenes and S. aureus have been reported.

▸ Tetracyclines. The tetracyclines have some coverage for community-acquired MRSA. However, there are some resistance issues, and these agents can discolor childrens' teeth and cause photosensitivity.

▸ Fluoroquinolones. These drugs have a long half-life, and early studies suggest they are as efficacious as β-lactams for erysipelas, cellulitis, impetigo, surgical wounds, and diabetic foot infections. However, resistance is increasing. Possible adverse effects include tendonitis and tendon rupture in adults. They are contraindicated in pediatric patients.

▸ Lincosamides. Clindamycin has good activity against S. pyogenes and methicillin-susceptible strains of S. aureus. It is also active against some MRSA strains. Resistance to erythromycin could signal inducible resistance to clindamycin, Dr. Scher said. A higher risk of pseudomembranous colitis is associated with Clostridium difficile. Dosing is t.i.d.

▸ Trimethoprim-sulfamethoxazole. This combination covers some community-acquired MRSA infections. There is some resistance among staphylococci and no coverage for streptococci. Possible adverse reactions include rash and photosensitivity.

Factors that may alter antimicrobial decision making include emerging macrolide resistance among the β-hemolytic or viridans-group streptococci, Dr. Scher noted. Community-acquired MRSA might also be resistant to β-lactams, macrolides, and quinolones, further limiting choices.

MIAMI BEACH — There are many options for antibiotic treatment of uncomplicated and complicated skin infections, each with its own advantages and disadvantages, according to a presentation by Richard K. Scher, M.D., at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

Major goals of therapy include prompt eradication of the infection, reduction of potential antibiotic resistance, and lower risk of recurrence. Safety, efficacy, cost, compliance, managed care formularies, and community-acquired methicillin-resistant Staphylococcus aureus (MRSA) are important considerations when individualizing therapy, according to Dr. Scher, professor of clinical dermatology at Columbia University, New York.

Uncomplicated infections affect superficial skin tissue and include furuncles, cellulites, folliculitis, simple abscesses, and impetiginous lesions. Complicated infections affect deeper soft tissue or require significant surgery, such as infected ulcers, burns, or major abscesses. Infections are also complicated in the presence of significant underlying disease or if the affected site carries a higher risk for anaerobic or gram-negative infection, such as the rectal area.

Severe atopic dermatitis, poorly controlled diabetes, and patients with kidney failure may be predisposed to skin infections. Other risk factors are leukemia or lymphoma; malnutrition and low serum iron; alcohol abuse; intravenous drug use; and medications including systemic steroids, retinoids, cytotoxic agents, and immunosuppressants.

Dr. Scher discussed these options for treating skin structure infections:

▸ Cephalosporins. These drugs have good tolerability and good sensitivity. The risk of hypersensitivity is low, probably less than 2%, for a patient with a history of nonanaphylactic penicillin allergy.

First-generation drugs in this class include cephalexin and cefadroxil. They have good activity against S. pyogenes and MRSA. Dosing is t.i.d. to q.i.d.

Second-generation cephalosporins include cefaclor and cefuroxime, which have expanded activity against gram-negative bacteria and a longer half-life than the first-generation drugs. Dosing is b.i.d.

Third-generation agents include cefixime and ceftibuten. They are good for gram-negative organisms but not as good for gram-positive bacteria, Dr. Scher noted. Dosing is once daily or b.i.d.

Extended-spectrum cephalosporins include cefdinir and cefpodoxime, which are active against gram-negative and gram-positive bacteria. Cefdinir is administered b.i.d.

▸ Penicillins. S. pyogenes is always sensitive to treatment with penicillins, but because of cross resistance from MRSA, S. aureus is no longer sensitive. Drugs in this class that are β-lactamase stable exhibit good antistaphylococcal activity. Most dosing is t.i.d. or q.i.d.

▸ Macrolides. These drugs include erythromycin, clarithromycin, and azithromycin. They are less likely to be used because of concerns about resistance, Dr. Scher said. Increasing resistance to S. pyogenes and S. aureus have been reported.

▸ Tetracyclines. The tetracyclines have some coverage for community-acquired MRSA. However, there are some resistance issues, and these agents can discolor childrens' teeth and cause photosensitivity.

▸ Fluoroquinolones. These drugs have a long half-life, and early studies suggest they are as efficacious as β-lactams for erysipelas, cellulitis, impetigo, surgical wounds, and diabetic foot infections. However, resistance is increasing. Possible adverse effects include tendonitis and tendon rupture in adults. They are contraindicated in pediatric patients.

▸ Lincosamides. Clindamycin has good activity against S. pyogenes and methicillin-susceptible strains of S. aureus. It is also active against some MRSA strains. Resistance to erythromycin could signal inducible resistance to clindamycin, Dr. Scher said. A higher risk of pseudomembranous colitis is associated with Clostridium difficile. Dosing is t.i.d.

▸ Trimethoprim-sulfamethoxazole. This combination covers some community-acquired MRSA infections. There is some resistance among staphylococci and no coverage for streptococci. Possible adverse reactions include rash and photosensitivity.

Factors that may alter antimicrobial decision making include emerging macrolide resistance among the β-hemolytic or viridans-group streptococci, Dr. Scher noted. Community-acquired MRSA might also be resistant to β-lactams, macrolides, and quinolones, further limiting choices.

MIAMI BEACH — There are many options for antibiotic treatment of uncomplicated and complicated skin infections, each with its own advantages and disadvantages, according to a presentation by Richard K. Scher, M.D., at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

Major goals of therapy include prompt eradication of the infection, reduction of potential antibiotic resistance, and lower risk of recurrence. Safety, efficacy, cost, compliance, managed care formularies, and community-acquired methicillin-resistant Staphylococcus aureus (MRSA) are important considerations when individualizing therapy, according to Dr. Scher, professor of clinical dermatology at Columbia University, New York.

Uncomplicated infections affect superficial skin tissue and include furuncles, cellulites, folliculitis, simple abscesses, and impetiginous lesions. Complicated infections affect deeper soft tissue or require significant surgery, such as infected ulcers, burns, or major abscesses. Infections are also complicated in the presence of significant underlying disease or if the affected site carries a higher risk for anaerobic or gram-negative infection, such as the rectal area.

Severe atopic dermatitis, poorly controlled diabetes, and patients with kidney failure may be predisposed to skin infections. Other risk factors are leukemia or lymphoma; malnutrition and low serum iron; alcohol abuse; intravenous drug use; and medications including systemic steroids, retinoids, cytotoxic agents, and immunosuppressants.

Dr. Scher discussed these options for treating skin structure infections:

▸ Cephalosporins. These drugs have good tolerability and good sensitivity. The risk of hypersensitivity is low, probably less than 2%, for a patient with a history of nonanaphylactic penicillin allergy.

First-generation drugs in this class include cephalexin and cefadroxil. They have good activity against S. pyogenes and MRSA. Dosing is t.i.d. to q.i.d.

Second-generation cephalosporins include cefaclor and cefuroxime, which have expanded activity against gram-negative bacteria and a longer half-life than the first-generation drugs. Dosing is b.i.d.

Third-generation agents include cefixime and ceftibuten. They are good for gram-negative organisms but not as good for gram-positive bacteria, Dr. Scher noted. Dosing is once daily or b.i.d.

Extended-spectrum cephalosporins include cefdinir and cefpodoxime, which are active against gram-negative and gram-positive bacteria. Cefdinir is administered b.i.d.

▸ Penicillins. S. pyogenes is always sensitive to treatment with penicillins, but because of cross resistance from MRSA, S. aureus is no longer sensitive. Drugs in this class that are β-lactamase stable exhibit good antistaphylococcal activity. Most dosing is t.i.d. or q.i.d.

▸ Macrolides. These drugs include erythromycin, clarithromycin, and azithromycin. They are less likely to be used because of concerns about resistance, Dr. Scher said. Increasing resistance to S. pyogenes and S. aureus have been reported.

▸ Tetracyclines. The tetracyclines have some coverage for community-acquired MRSA. However, there are some resistance issues, and these agents can discolor childrens' teeth and cause photosensitivity.

▸ Fluoroquinolones. These drugs have a long half-life, and early studies suggest they are as efficacious as β-lactams for erysipelas, cellulitis, impetigo, surgical wounds, and diabetic foot infections. However, resistance is increasing. Possible adverse effects include tendonitis and tendon rupture in adults. They are contraindicated in pediatric patients.

▸ Lincosamides. Clindamycin has good activity against S. pyogenes and methicillin-susceptible strains of S. aureus. It is also active against some MRSA strains. Resistance to erythromycin could signal inducible resistance to clindamycin, Dr. Scher said. A higher risk of pseudomembranous colitis is associated with Clostridium difficile. Dosing is t.i.d.

▸ Trimethoprim-sulfamethoxazole. This combination covers some community-acquired MRSA infections. There is some resistance among staphylococci and no coverage for streptococci. Possible adverse reactions include rash and photosensitivity.

Factors that may alter antimicrobial decision making include emerging macrolide resistance among the β-hemolytic or viridans-group streptococci, Dr. Scher noted. Community-acquired MRSA might also be resistant to β-lactams, macrolides, and quinolones, further limiting choices.

NEW ORLEANS — A substantial number of people in the U.S. Hispanic community self-medicate with oral antibiotics, according to a study presented at the annual conference of the Society of Teachers of Family Medicine.

Many countries in Latin America dispense antibiotics without a prescription, and individuals from these countries have cultural norms for self-medication, said Arch G. Mainous III, Ph.D. The researchers interviewed 219 self-identified Hispanics, and 45% indicated they had purchased nonprescribed antibiotics outside the United States at some time; 16% had imported them. “Those results were striking,” said Dr. Mainous, professor of family medicine at the Medical University of South Carolina, Charleston. “Another striking feature was that 19% had acquired antibiotics not prescribed for the person in the United States; 93% [of them] said they got them in stores.”

Latin America has a high level of antibiotic resistance, Dr. Mainous said. U.S. interventions on resistance have decreased antibiotic prescribing, but they focus on prescribing. To correct inappropriate acquisition and use, patient education materials should not only be available in Spanish, but also should be culturally sensitive, he suggested.

The findings of the study, Dr. Mainous said, “point to a large unrecognized reservoir of nonprescribed antibiotics likely used for inappropriate self-medication. We know from other studies that people in countries where antibiotics are available tend to take subtherapeutic doses.”

Trained bilingual interviewers used a standard questionnaire to learn acquisition history and attitudes regarding nonprescribed antibiotics. All participants were 18 years and older and were recruited from one of two clinics in Charleston. The individuals were not necessarily patients, Dr. Mainous said.

The majority, 75%, indicated Mexico as their country of birth; 41% said they had been in the United States fewer than 4 years; and 90% did not have medical insurance.

The common cold, ear infections, cough, and sore throat were the primary illnesses for which respondents took nonprescribed antibiotics.

A large proportion (31%) of Hispanics surveyed thought antibiotics should be available over the counter, Dr. Mainous said. The belief that antibiotics should be available over the counter and past purchases outside the United States were highly related, he added.

Of interviewed individuals, 64% said they acquired antibiotics without a prescription because it was preferable to a physician visit. “Only 7% said there was a language barrier, so most did not want to spend the money or go to a doctor.”

Dr. Mainous pointed out that this phenomenon is not limited to Hispanics. “People in the Philippines, Taiwan, and Bangladesh will also buy subtherapeutic doses for self-medication.”

NEW ORLEANS — A substantial number of people in the U.S. Hispanic community self-medicate with oral antibiotics, according to a study presented at the annual conference of the Society of Teachers of Family Medicine.

Many countries in Latin America dispense antibiotics without a prescription, and individuals from these countries have cultural norms for self-medication, said Arch G. Mainous III, Ph.D. The researchers interviewed 219 self-identified Hispanics, and 45% indicated they had purchased nonprescribed antibiotics outside the United States at some time; 16% had imported them. “Those results were striking,” said Dr. Mainous, professor of family medicine at the Medical University of South Carolina, Charleston. “Another striking feature was that 19% had acquired antibiotics not prescribed for the person in the United States; 93% [of them] said they got them in stores.”

Latin America has a high level of antibiotic resistance, Dr. Mainous said. U.S. interventions on resistance have decreased antibiotic prescribing, but they focus on prescribing. To correct inappropriate acquisition and use, patient education materials should not only be available in Spanish, but also should be culturally sensitive, he suggested.

The findings of the study, Dr. Mainous said, “point to a large unrecognized reservoir of nonprescribed antibiotics likely used for inappropriate self-medication. We know from other studies that people in countries where antibiotics are available tend to take subtherapeutic doses.”

Trained bilingual interviewers used a standard questionnaire to learn acquisition history and attitudes regarding nonprescribed antibiotics. All participants were 18 years and older and were recruited from one of two clinics in Charleston. The individuals were not necessarily patients, Dr. Mainous said.

The majority, 75%, indicated Mexico as their country of birth; 41% said they had been in the United States fewer than 4 years; and 90% did not have medical insurance.

The common cold, ear infections, cough, and sore throat were the primary illnesses for which respondents took nonprescribed antibiotics.

A large proportion (31%) of Hispanics surveyed thought antibiotics should be available over the counter, Dr. Mainous said. The belief that antibiotics should be available over the counter and past purchases outside the United States were highly related, he added.

Of interviewed individuals, 64% said they acquired antibiotics without a prescription because it was preferable to a physician visit. “Only 7% said there was a language barrier, so most did not want to spend the money or go to a doctor.”

Dr. Mainous pointed out that this phenomenon is not limited to Hispanics. “People in the Philippines, Taiwan, and Bangladesh will also buy subtherapeutic doses for self-medication.”

NEW ORLEANS — A substantial number of people in the U.S. Hispanic community self-medicate with oral antibiotics, according to a study presented at the annual conference of the Society of Teachers of Family Medicine.

Many countries in Latin America dispense antibiotics without a prescription, and individuals from these countries have cultural norms for self-medication, said Arch G. Mainous III, Ph.D. The researchers interviewed 219 self-identified Hispanics, and 45% indicated they had purchased nonprescribed antibiotics outside the United States at some time; 16% had imported them. “Those results were striking,” said Dr. Mainous, professor of family medicine at the Medical University of South Carolina, Charleston. “Another striking feature was that 19% had acquired antibiotics not prescribed for the person in the United States; 93% [of them] said they got them in stores.”

Latin America has a high level of antibiotic resistance, Dr. Mainous said. U.S. interventions on resistance have decreased antibiotic prescribing, but they focus on prescribing. To correct inappropriate acquisition and use, patient education materials should not only be available in Spanish, but also should be culturally sensitive, he suggested.

The findings of the study, Dr. Mainous said, “point to a large unrecognized reservoir of nonprescribed antibiotics likely used for inappropriate self-medication. We know from other studies that people in countries where antibiotics are available tend to take subtherapeutic doses.”

Trained bilingual interviewers used a standard questionnaire to learn acquisition history and attitudes regarding nonprescribed antibiotics. All participants were 18 years and older and were recruited from one of two clinics in Charleston. The individuals were not necessarily patients, Dr. Mainous said.

The majority, 75%, indicated Mexico as their country of birth; 41% said they had been in the United States fewer than 4 years; and 90% did not have medical insurance.

The common cold, ear infections, cough, and sore throat were the primary illnesses for which respondents took nonprescribed antibiotics.

A large proportion (31%) of Hispanics surveyed thought antibiotics should be available over the counter, Dr. Mainous said. The belief that antibiotics should be available over the counter and past purchases outside the United States were highly related, he added.

Of interviewed individuals, 64% said they acquired antibiotics without a prescription because it was preferable to a physician visit. “Only 7% said there was a language barrier, so most did not want to spend the money or go to a doctor.”

Dr. Mainous pointed out that this phenomenon is not limited to Hispanics. “People in the Philippines, Taiwan, and Bangladesh will also buy subtherapeutic doses for self-medication.”

NEW ORLEANS — Electronic health records in primary care practices did not improve physician adherence to evidence-based diabetes guidelines, according to one study.

Researchers found that the 37 practices without electronic health records (EHRs) provided equal or better diabetes care than 17 with the technology, “but there is much room for improvement in both groups,” Jesse C. Crosson, Ph.D., said at the annual conference of the Society of Teachers of Family Medicine.

Although the use of information technology is recommended to improve quality of care and reduce errors, EHR capabilities are unevenly used in primary care, Dr. Crosson said.

“My best explanation is if you add a complex information tool to a practice where people do not pay as much attention to other members of the practice, it can cause chaos and worsen things,” said Dr. Crosson of the department of family medicine at New Jersey Medical School, Newark.

Practices with a greater orientation toward patient care, characterized by relatively open scheduling and physicians who are easy to contact, are more likely to optimize use of EHRs, Dr. Crosson said. On the other hand, practices with more of a business outlook, a greater focus on money and the bottom line, and with longer wait times for patients tend to integrate them less well, he explained.

The researchers focused on type 2 diabetes because clinical care is complex and treatment guidelines are interrelated, Dr. Crosson said. He and his associates theorized that information technology might improve attainment of clinical diabetes targets.

The researchers reviewed the charts of 1,080 randomly selected diabetes patients, reflecting 20 patients each from 54 primary care practices in New Jersey and Pennsylvania. There were no significant differences between EHR and non-EHR practices in terms of number of physicians, number of examination rooms, years in practice, or type of practice.

There were no statistically significant differences between practices with or without EHRs in head-to-head comparisons. In the multivariate analyses, however, non-EHR practices did better in assessment, medication management, and outcome targets, Dr. Crosson said. The targets were LDL cholesterol below 100 mg/dL, hemoglobin A_1c below 7%, and blood pressure below 130/85 mm Hg.

Overall, 52% of participants met three out of the following five criteria: HbA_1c tested in the last 6 months; microalbumin tested in last 12 months; smoking assessment documented; LDL cholesterol tested in last 12 months; and blood pressure assessed at every visit.

Limitations of the study include its retrospective design. “We were really limited to what was in the medical record. We do not have income, race, or insurance status,” he said, adding that since it was not a randomized controlled trial, there may be selection biases.

NEW ORLEANS — Electronic health records in primary care practices did not improve physician adherence to evidence-based diabetes guidelines, according to one study.

Researchers found that the 37 practices without electronic health records (EHRs) provided equal or better diabetes care than 17 with the technology, “but there is much room for improvement in both groups,” Jesse C. Crosson, Ph.D., said at the annual conference of the Society of Teachers of Family Medicine.

Although the use of information technology is recommended to improve quality of care and reduce errors, EHR capabilities are unevenly used in primary care, Dr. Crosson said.

“My best explanation is if you add a complex information tool to a practice where people do not pay as much attention to other members of the practice, it can cause chaos and worsen things,” said Dr. Crosson of the department of family medicine at New Jersey Medical School, Newark.

Practices with a greater orientation toward patient care, characterized by relatively open scheduling and physicians who are easy to contact, are more likely to optimize use of EHRs, Dr. Crosson said. On the other hand, practices with more of a business outlook, a greater focus on money and the bottom line, and with longer wait times for patients tend to integrate them less well, he explained.

The researchers focused on type 2 diabetes because clinical care is complex and treatment guidelines are interrelated, Dr. Crosson said. He and his associates theorized that information technology might improve attainment of clinical diabetes targets.

The researchers reviewed the charts of 1,080 randomly selected diabetes patients, reflecting 20 patients each from 54 primary care practices in New Jersey and Pennsylvania. There were no significant differences between EHR and non-EHR practices in terms of number of physicians, number of examination rooms, years in practice, or type of practice.

There were no statistically significant differences between practices with or without EHRs in head-to-head comparisons. In the multivariate analyses, however, non-EHR practices did better in assessment, medication management, and outcome targets, Dr. Crosson said. The targets were LDL cholesterol below 100 mg/dL, hemoglobin A_1c below 7%, and blood pressure below 130/85 mm Hg.

Overall, 52% of participants met three out of the following five criteria: HbA_1c tested in the last 6 months; microalbumin tested in last 12 months; smoking assessment documented; LDL cholesterol tested in last 12 months; and blood pressure assessed at every visit.

Limitations of the study include its retrospective design. “We were really limited to what was in the medical record. We do not have income, race, or insurance status,” he said, adding that since it was not a randomized controlled trial, there may be selection biases.

NEW ORLEANS — Electronic health records in primary care practices did not improve physician adherence to evidence-based diabetes guidelines, according to one study.

Researchers found that the 37 practices without electronic health records (EHRs) provided equal or better diabetes care than 17 with the technology, “but there is much room for improvement in both groups,” Jesse C. Crosson, Ph.D., said at the annual conference of the Society of Teachers of Family Medicine.

Although the use of information technology is recommended to improve quality of care and reduce errors, EHR capabilities are unevenly used in primary care, Dr. Crosson said.

“My best explanation is if you add a complex information tool to a practice where people do not pay as much attention to other members of the practice, it can cause chaos and worsen things,” said Dr. Crosson of the department of family medicine at New Jersey Medical School, Newark.

Practices with a greater orientation toward patient care, characterized by relatively open scheduling and physicians who are easy to contact, are more likely to optimize use of EHRs, Dr. Crosson said. On the other hand, practices with more of a business outlook, a greater focus on money and the bottom line, and with longer wait times for patients tend to integrate them less well, he explained.

The researchers focused on type 2 diabetes because clinical care is complex and treatment guidelines are interrelated, Dr. Crosson said. He and his associates theorized that information technology might improve attainment of clinical diabetes targets.

The researchers reviewed the charts of 1,080 randomly selected diabetes patients, reflecting 20 patients each from 54 primary care practices in New Jersey and Pennsylvania. There were no significant differences between EHR and non-EHR practices in terms of number of physicians, number of examination rooms, years in practice, or type of practice.

There were no statistically significant differences between practices with or without EHRs in head-to-head comparisons. In the multivariate analyses, however, non-EHR practices did better in assessment, medication management, and outcome targets, Dr. Crosson said. The targets were LDL cholesterol below 100 mg/dL, hemoglobin A_1c below 7%, and blood pressure below 130/85 mm Hg.

Overall, 52% of participants met three out of the following five criteria: HbA_1c tested in the last 6 months; microalbumin tested in last 12 months; smoking assessment documented; LDL cholesterol tested in last 12 months; and blood pressure assessed at every visit.

Limitations of the study include its retrospective design. “We were really limited to what was in the medical record. We do not have income, race, or insurance status,” he said, adding that since it was not a randomized controlled trial, there may be selection biases.

MIAMI BEACH — The antiparkinsonism drug ropinirole is now indicated for the treatment of adults with moderate to severe restless legs syndrome.

The Food and Drug Administration approved the new indication based on three randomized, double-blind, controlled trials that showed significant improvements in patient and physician symptom ratings, compared with placebo.

One of these studies showed that ropinirole (Requip, from GlaxoSmithKline Inc.) was well tolerated and effective at improving symptoms in as little as 1 week. Richard Bogan, M.D., presented results of this phase III study at the annual meeting of the American Academy of Neurology.

Restless legs syndrome is a sensorimotor neurologic disorder affecting 5%–10% of the U.S. population. The condition causes considerable sleep disturbance and impairs quality of life for some patients. Although the pathogenesis is unknown, dopamine agonists such as ropinirole may be effective as first-line treatment for moderate to severe cases, according to Dr. Bogan of the University of South Carolina.

To test safety and efficacy, Dr. Bogan and his colleagues randomized 187 patients to ropinirole and 193 others to placebo in a 12-week, double-blind, multicenter trial. All participants had mild to moderate impairment; entry requirements included an International Restless Legs Syndrome (IRLS) study group criteria score of 15 or more, at least 15 nights of symptoms in the last month, and 4 nights of symptoms in the last 7 nights.

“Patients do have changes in quality of life, and ropinirole can improve their lives,” said Dr. Bogan, president and medical director of SleepMed Inc.

The primary measure of efficacy was change in IRLS score between baseline and the last clinical observation before the end of the 12-week trial. Secondary outcomes included the change in IRLS score from baseline to week 1 and the proportion of patients in each group with a score of “much improved” or “very much improved” at weeks 1 and 12 on the Clinical Global Impression-Improvement scale. In addition, researchers assessed sleep quantity and quality with the Medical Outcomes Study sleep scale.

All participants were adults, with a mean age of 52 years (range 18–79 years). Women accounted for 58% of the ropinirole group and 63% of the placebo group. A total of 164 ropinirole recipients and 167 placebo recipients completed the study.

The treatment group received once-daily ropinirole 0.25 mg at baseline, 1–3 hours before bedtime. Dosages were titrated up to 4.0 mg/day to optimize efficacy without side effects. Dr. Bogan has received research grants from GlaxoSmithKline, the sponsor of this study.

There were “highly statistically significant” improvements in patient subjective assessments on the IRLS scale, Dr. Bogan said. Ropinirole reduced IRLS scores a mean of 3.7 points, compared with 2.0 points for placebo, at the patient's last clinical observation, which occurred either at 12 weeks or, in some cases, earlier.

Changes on the global impression scale “were highly statistically significant as well, although clearly, there is a placebo effect.” The proportion of patients with a Clinical Global Impression score of “much” or “very much improved” was significantly higher for ropinirole than placebo at week 12 (2.1 adjusted odds ratio).

“I am frustrated by my inability to tease out the placebo effect, by the scales we use, and the variability of their symptoms,” Dr. Bogan said in response to a question from the audience.

Ropinirole was associated with symptom relief as early as the first week of treatment. IRLS scores dropped by 4.1 points in the drug group versus 2.7 points in the placebo group at the end of the first week.

In addition, a significantly higher proportion of ropinirole participants had Clinical Global Impression improvements at week 1 (2.4 adjusted odds ratio).

The treatment also provided qualitative improvements in sleep. Measures of sleep adequacy and quantity showed patients on active therapy experienced “dramatic improvements, especially in quantity of sleep,” Dr. Bogan said.

Ropinirole was generally well tolerated, he reported. The most common adverse events associated with ropinirole treatment were nausea, headache, and somnolence.

Nausea, for example, occurred in 42% of the treatment group, versus 8% of the placebo group. Withdrawals because of adverse events were similar; five patients in the ropinirole group and eight in the placebo group withdrew from the study.

MIAMI BEACH — The antiparkinsonism drug ropinirole is now indicated for the treatment of adults with moderate to severe restless legs syndrome.

The Food and Drug Administration approved the new indication based on three randomized, double-blind, controlled trials that showed significant improvements in patient and physician symptom ratings, compared with placebo.

One of these studies showed that ropinirole (Requip, from GlaxoSmithKline Inc.) was well tolerated and effective at improving symptoms in as little as 1 week. Richard Bogan, M.D., presented results of this phase III study at the annual meeting of the American Academy of Neurology.

Restless legs syndrome is a sensorimotor neurologic disorder affecting 5%–10% of the U.S. population. The condition causes considerable sleep disturbance and impairs quality of life for some patients. Although the pathogenesis is unknown, dopamine agonists such as ropinirole may be effective as first-line treatment for moderate to severe cases, according to Dr. Bogan of the University of South Carolina.

To test safety and efficacy, Dr. Bogan and his colleagues randomized 187 patients to ropinirole and 193 others to placebo in a 12-week, double-blind, multicenter trial. All participants had mild to moderate impairment; entry requirements included an International Restless Legs Syndrome (IRLS) study group criteria score of 15 or more, at least 15 nights of symptoms in the last month, and 4 nights of symptoms in the last 7 nights.

“Patients do have changes in quality of life, and ropinirole can improve their lives,” said Dr. Bogan, president and medical director of SleepMed Inc.

The primary measure of efficacy was change in IRLS score between baseline and the last clinical observation before the end of the 12-week trial. Secondary outcomes included the change in IRLS score from baseline to week 1 and the proportion of patients in each group with a score of “much improved” or “very much improved” at weeks 1 and 12 on the Clinical Global Impression-Improvement scale. In addition, researchers assessed sleep quantity and quality with the Medical Outcomes Study sleep scale.

All participants were adults, with a mean age of 52 years (range 18–79 years). Women accounted for 58% of the ropinirole group and 63% of the placebo group. A total of 164 ropinirole recipients and 167 placebo recipients completed the study.

The treatment group received once-daily ropinirole 0.25 mg at baseline, 1–3 hours before bedtime. Dosages were titrated up to 4.0 mg/day to optimize efficacy without side effects. Dr. Bogan has received research grants from GlaxoSmithKline, the sponsor of this study.

There were “highly statistically significant” improvements in patient subjective assessments on the IRLS scale, Dr. Bogan said. Ropinirole reduced IRLS scores a mean of 3.7 points, compared with 2.0 points for placebo, at the patient's last clinical observation, which occurred either at 12 weeks or, in some cases, earlier.

Changes on the global impression scale “were highly statistically significant as well, although clearly, there is a placebo effect.” The proportion of patients with a Clinical Global Impression score of “much” or “very much improved” was significantly higher for ropinirole than placebo at week 12 (2.1 adjusted odds ratio).

“I am frustrated by my inability to tease out the placebo effect, by the scales we use, and the variability of their symptoms,” Dr. Bogan said in response to a question from the audience.

Ropinirole was associated with symptom relief as early as the first week of treatment. IRLS scores dropped by 4.1 points in the drug group versus 2.7 points in the placebo group at the end of the first week.

In addition, a significantly higher proportion of ropinirole participants had Clinical Global Impression improvements at week 1 (2.4 adjusted odds ratio).

The treatment also provided qualitative improvements in sleep. Measures of sleep adequacy and quantity showed patients on active therapy experienced “dramatic improvements, especially in quantity of sleep,” Dr. Bogan said.

Ropinirole was generally well tolerated, he reported. The most common adverse events associated with ropinirole treatment were nausea, headache, and somnolence.

Nausea, for example, occurred in 42% of the treatment group, versus 8% of the placebo group. Withdrawals because of adverse events were similar; five patients in the ropinirole group and eight in the placebo group withdrew from the study.

MIAMI BEACH — The antiparkinsonism drug ropinirole is now indicated for the treatment of adults with moderate to severe restless legs syndrome.

The Food and Drug Administration approved the new indication based on three randomized, double-blind, controlled trials that showed significant improvements in patient and physician symptom ratings, compared with placebo.

One of these studies showed that ropinirole (Requip, from GlaxoSmithKline Inc.) was well tolerated and effective at improving symptoms in as little as 1 week. Richard Bogan, M.D., presented results of this phase III study at the annual meeting of the American Academy of Neurology.

Restless legs syndrome is a sensorimotor neurologic disorder affecting 5%–10% of the U.S. population. The condition causes considerable sleep disturbance and impairs quality of life for some patients. Although the pathogenesis is unknown, dopamine agonists such as ropinirole may be effective as first-line treatment for moderate to severe cases, according to Dr. Bogan of the University of South Carolina.

To test safety and efficacy, Dr. Bogan and his colleagues randomized 187 patients to ropinirole and 193 others to placebo in a 12-week, double-blind, multicenter trial. All participants had mild to moderate impairment; entry requirements included an International Restless Legs Syndrome (IRLS) study group criteria score of 15 or more, at least 15 nights of symptoms in the last month, and 4 nights of symptoms in the last 7 nights.

“Patients do have changes in quality of life, and ropinirole can improve their lives,” said Dr. Bogan, president and medical director of SleepMed Inc.

The primary measure of efficacy was change in IRLS score between baseline and the last clinical observation before the end of the 12-week trial. Secondary outcomes included the change in IRLS score from baseline to week 1 and the proportion of patients in each group with a score of “much improved” or “very much improved” at weeks 1 and 12 on the Clinical Global Impression-Improvement scale. In addition, researchers assessed sleep quantity and quality with the Medical Outcomes Study sleep scale.

All participants were adults, with a mean age of 52 years (range 18–79 years). Women accounted for 58% of the ropinirole group and 63% of the placebo group. A total of 164 ropinirole recipients and 167 placebo recipients completed the study.

The treatment group received once-daily ropinirole 0.25 mg at baseline, 1–3 hours before bedtime. Dosages were titrated up to 4.0 mg/day to optimize efficacy without side effects. Dr. Bogan has received research grants from GlaxoSmithKline, the sponsor of this study.

There were “highly statistically significant” improvements in patient subjective assessments on the IRLS scale, Dr. Bogan said. Ropinirole reduced IRLS scores a mean of 3.7 points, compared with 2.0 points for placebo, at the patient's last clinical observation, which occurred either at 12 weeks or, in some cases, earlier.

Changes on the global impression scale “were highly statistically significant as well, although clearly, there is a placebo effect.” The proportion of patients with a Clinical Global Impression score of “much” or “very much improved” was significantly higher for ropinirole than placebo at week 12 (2.1 adjusted odds ratio).

“I am frustrated by my inability to tease out the placebo effect, by the scales we use, and the variability of their symptoms,” Dr. Bogan said in response to a question from the audience.

Ropinirole was associated with symptom relief as early as the first week of treatment. IRLS scores dropped by 4.1 points in the drug group versus 2.7 points in the placebo group at the end of the first week.

In addition, a significantly higher proportion of ropinirole participants had Clinical Global Impression improvements at week 1 (2.4 adjusted odds ratio).

The treatment also provided qualitative improvements in sleep. Measures of sleep adequacy and quantity showed patients on active therapy experienced “dramatic improvements, especially in quantity of sleep,” Dr. Bogan said.

Ropinirole was generally well tolerated, he reported. The most common adverse events associated with ropinirole treatment were nausea, headache, and somnolence.

Nausea, for example, occurred in 42% of the treatment group, versus 8% of the placebo group. Withdrawals because of adverse events were similar; five patients in the ropinirole group and eight in the placebo group withdrew from the study.

MIAMI BEACH — Operator errors are responsible for more than half of the failures of deep brain stimulation to lessen essential tremor or Parkinson's symptoms, according to the findings of one study presented at the American Academy of Neurology annual meeting.

Many of these patients benefit when deep brain stimulation (DBS) is repeated at movement disorder centers by more experienced physicians.

The Food and Drug Administration approved a DBS system (Activa, manufactured by Medtronic Inc.) to treat patients with essential tremor or Parkinson's disease in August 1997. The agency expanded the system's indication to include patients with dystonia in April 2003.

DBS improves quality of life for many patients, but others do not respond. Incorrect diagnosis, surgical lead misplacement, and device-related errors are among the preventable problems identified by Michael S. Okun, M.D., and his associates.

“There has been a surge in centers providing DBS after its FDA approval and an increasing number of patients presenting to experienced DBS centers with complaints,” said Dr. Okun, co-director of the Movement Disorders Center at the University of Florida in Gainesville. “About 12 patients per year are seen by centers of excellence for these referred problems.”

A lack of consensus on patient screening, provider training, and the best multidisciplinary approach contribute to the failure rate, Dr. Okun said. In addition, there is no consensus on management of complications, some of which spur referral of the patient to an experienced DBS center for management.

Records of 41 consecutive patients treated at the University of Florida movement disorders center or the movement disorders center at the Beth Israel Medical Center in New York City were reviewed. The average age was 63 years. Thirty patients (73%) saw a movement disorders specialist prior to DBS implantation. Five patients (12%) had significant cognitive dysfunction before implantation. The patients underwent the following types of DBS implantation: 21, bilateral subthalamic nucleus; 8, unilateral subthalamic nucleus; 8, unilateral ventral intermediate nucleus; 1, unilateral globus pallidus interna; 1, bilateral ventral intermediate nucleus; and 1, bilateral globus pallidus interna.

All participants saw a movement disorders neurologist upon referral.

More than one-third, 36%, of patients had no improvement, and 15% had minimal improvement. However, “51% had significant improvement or were rescued with good outcomes,” Dr. Okun said.

“The reasons for DBS failures were not only surgical,” Dr. Okun said.

The researchers identified a timeline of preventable problems associated with DBS surgery. “It is quite interesting because many things were quite correctable,” Dr. Okun said. “There is an expertise factor we can improve on.”

Preventable problems included:

▸ Incorrect diagnosis (10 instances).

▸ Inadequate medication trial/dementia (10).

▸ Misplaced leads (19).

▸ Inadequate device programming (15).

▸ Medication adjustments (30).

Preoperative diagnoses included 31 with Parkinson's disease, 9 with essential tremor, and 1 patient with dystonia. The actual diagnoses were 26 with Parkinson's disease, 5 with essential tremor, 1 with dystonia, 3 with Parkinson's disease with dementia, 2 with multiple system atrophy, 1 with Parkinson's disease/essential tremor, 1 with corticobasal ganglionic degeneration, 1 with progressive nuclear palsy, and 1 with myoclonus.

Patients improved after 7 of the 19 misplaced leads were replaced, and partially improved after 3 others were replaced.

Programming problems included inadequate programming (15 patients), no or poor access to programming (7 patients), and difficult access to follow-up because of relocation (2 patients, 2 physicians). Reprogramming was successful for 15 patients and partially successful for 6.

A majority, 73%, of participants required medication changes. Dr. Okun said, “This brings home the point that even after surgery patients often need medication adjustments.”

Selection bias was a possible shortcoming of the study.

He said there are many improvements that can be made to prevent DBS failures and to improve outcomes.

Dr. Okun teaches programming the Activa DBS system for Medtronic.

Operator errors caused more than half of all cases of deep brain stimulation failure. Shown are examples of DBS lead misplacement: in the ventricle (left), atop the thalamus (right). Photos courtesy Dr. Michael S. Okun

MIAMI BEACH — Operator errors are responsible for more than half of the failures of deep brain stimulation to lessen essential tremor or Parkinson's symptoms, according to the findings of one study presented at the American Academy of Neurology annual meeting.

Many of these patients benefit when deep brain stimulation (DBS) is repeated at movement disorder centers by more experienced physicians.

The Food and Drug Administration approved a DBS system (Activa, manufactured by Medtronic Inc.) to treat patients with essential tremor or Parkinson's disease in August 1997. The agency expanded the system's indication to include patients with dystonia in April 2003.

DBS improves quality of life for many patients, but others do not respond. Incorrect diagnosis, surgical lead misplacement, and device-related errors are among the preventable problems identified by Michael S. Okun, M.D., and his associates.

“There has been a surge in centers providing DBS after its FDA approval and an increasing number of patients presenting to experienced DBS centers with complaints,” said Dr. Okun, co-director of the Movement Disorders Center at the University of Florida in Gainesville. “About 12 patients per year are seen by centers of excellence for these referred problems.”

A lack of consensus on patient screening, provider training, and the best multidisciplinary approach contribute to the failure rate, Dr. Okun said. In addition, there is no consensus on management of complications, some of which spur referral of the patient to an experienced DBS center for management.

Records of 41 consecutive patients treated at the University of Florida movement disorders center or the movement disorders center at the Beth Israel Medical Center in New York City were reviewed. The average age was 63 years. Thirty patients (73%) saw a movement disorders specialist prior to DBS implantation. Five patients (12%) had significant cognitive dysfunction before implantation. The patients underwent the following types of DBS implantation: 21, bilateral subthalamic nucleus; 8, unilateral subthalamic nucleus; 8, unilateral ventral intermediate nucleus; 1, unilateral globus pallidus interna; 1, bilateral ventral intermediate nucleus; and 1, bilateral globus pallidus interna.

All participants saw a movement disorders neurologist upon referral.

More than one-third, 36%, of patients had no improvement, and 15% had minimal improvement. However, “51% had significant improvement or were rescued with good outcomes,” Dr. Okun said.

“The reasons for DBS failures were not only surgical,” Dr. Okun said.

The researchers identified a timeline of preventable problems associated with DBS surgery. “It is quite interesting because many things were quite correctable,” Dr. Okun said. “There is an expertise factor we can improve on.”

Preventable problems included:

▸ Incorrect diagnosis (10 instances).

▸ Inadequate medication trial/dementia (10).

▸ Misplaced leads (19).

▸ Inadequate device programming (15).

▸ Medication adjustments (30).

Preoperative diagnoses included 31 with Parkinson's disease, 9 with essential tremor, and 1 patient with dystonia. The actual diagnoses were 26 with Parkinson's disease, 5 with essential tremor, 1 with dystonia, 3 with Parkinson's disease with dementia, 2 with multiple system atrophy, 1 with Parkinson's disease/essential tremor, 1 with corticobasal ganglionic degeneration, 1 with progressive nuclear palsy, and 1 with myoclonus.

Patients improved after 7 of the 19 misplaced leads were replaced, and partially improved after 3 others were replaced.

Programming problems included inadequate programming (15 patients), no or poor access to programming (7 patients), and difficult access to follow-up because of relocation (2 patients, 2 physicians). Reprogramming was successful for 15 patients and partially successful for 6.

A majority, 73%, of participants required medication changes. Dr. Okun said, “This brings home the point that even after surgery patients often need medication adjustments.”

Selection bias was a possible shortcoming of the study.

He said there are many improvements that can be made to prevent DBS failures and to improve outcomes.

Dr. Okun teaches programming the Activa DBS system for Medtronic.

Operator errors caused more than half of all cases of deep brain stimulation failure. Shown are examples of DBS lead misplacement: in the ventricle (left), atop the thalamus (right). Photos courtesy Dr. Michael S. Okun

MIAMI BEACH — Operator errors are responsible for more than half of the failures of deep brain stimulation to lessen essential tremor or Parkinson's symptoms, according to the findings of one study presented at the American Academy of Neurology annual meeting.

Many of these patients benefit when deep brain stimulation (DBS) is repeated at movement disorder centers by more experienced physicians.

The Food and Drug Administration approved a DBS system (Activa, manufactured by Medtronic Inc.) to treat patients with essential tremor or Parkinson's disease in August 1997. The agency expanded the system's indication to include patients with dystonia in April 2003.

DBS improves quality of life for many patients, but others do not respond. Incorrect diagnosis, surgical lead misplacement, and device-related errors are among the preventable problems identified by Michael S. Okun, M.D., and his associates.

“There has been a surge in centers providing DBS after its FDA approval and an increasing number of patients presenting to experienced DBS centers with complaints,” said Dr. Okun, co-director of the Movement Disorders Center at the University of Florida in Gainesville. “About 12 patients per year are seen by centers of excellence for these referred problems.”

A lack of consensus on patient screening, provider training, and the best multidisciplinary approach contribute to the failure rate, Dr. Okun said. In addition, there is no consensus on management of complications, some of which spur referral of the patient to an experienced DBS center for management.

Records of 41 consecutive patients treated at the University of Florida movement disorders center or the movement disorders center at the Beth Israel Medical Center in New York City were reviewed. The average age was 63 years. Thirty patients (73%) saw a movement disorders specialist prior to DBS implantation. Five patients (12%) had significant cognitive dysfunction before implantation. The patients underwent the following types of DBS implantation: 21, bilateral subthalamic nucleus; 8, unilateral subthalamic nucleus; 8, unilateral ventral intermediate nucleus; 1, unilateral globus pallidus interna; 1, bilateral ventral intermediate nucleus; and 1, bilateral globus pallidus interna.

All participants saw a movement disorders neurologist upon referral.

More than one-third, 36%, of patients had no improvement, and 15% had minimal improvement. However, “51% had significant improvement or were rescued with good outcomes,” Dr. Okun said.

“The reasons for DBS failures were not only surgical,” Dr. Okun said.

The researchers identified a timeline of preventable problems associated with DBS surgery. “It is quite interesting because many things were quite correctable,” Dr. Okun said. “There is an expertise factor we can improve on.”

Preventable problems included:

▸ Incorrect diagnosis (10 instances).

▸ Inadequate medication trial/dementia (10).

▸ Misplaced leads (19).

▸ Inadequate device programming (15).

▸ Medication adjustments (30).

Preoperative diagnoses included 31 with Parkinson's disease, 9 with essential tremor, and 1 patient with dystonia. The actual diagnoses were 26 with Parkinson's disease, 5 with essential tremor, 1 with dystonia, 3 with Parkinson's disease with dementia, 2 with multiple system atrophy, 1 with Parkinson's disease/essential tremor, 1 with corticobasal ganglionic degeneration, 1 with progressive nuclear palsy, and 1 with myoclonus.

Patients improved after 7 of the 19 misplaced leads were replaced, and partially improved after 3 others were replaced.

Programming problems included inadequate programming (15 patients), no or poor access to programming (7 patients), and difficult access to follow-up because of relocation (2 patients, 2 physicians). Reprogramming was successful for 15 patients and partially successful for 6.

A majority, 73%, of participants required medication changes. Dr. Okun said, “This brings home the point that even after surgery patients often need medication adjustments.”

Selection bias was a possible shortcoming of the study.

He said there are many improvements that can be made to prevent DBS failures and to improve outcomes.

Dr. Okun teaches programming the Activa DBS system for Medtronic.

Operator errors caused more than half of all cases of deep brain stimulation failure. Shown are examples of DBS lead misplacement: in the ventricle (left), atop the thalamus (right). Photos courtesy Dr. Michael S. Okun