Patrice Wendling

CHICAGO — Insulin resistance in teens increases their risk of high blood pressure as adults, according to a large, longitudinal study reported at a conference of the Council for High Blood Pressure Research.

Insulin resistance was assessed in teens from age 13 to 19 years and was found to be associated with higher systolic blood pressure independent of body mass index, said Alan Sinaiko, M.D., professor of pediatrics at the University of Minnesota in Minneapolis.

“Strategies designed to reduce childhood obesity to prevent atherosclerotic cardiovascular disease and type 2 diabetes may need to be complemented by treatment of insulin resistance,” Dr. Sinaiko said at the meeting, sponsored by the American Heart Association.

Dr. Sinaiko and his colleagues randomly recruited 357 Minneapolis grade school students. Over the next 6 years, the children were tested using a euglycemic hyperinsulinemic clamp at age 13 years (n = 357), at age 15 years (n = 309), and at age 19 years (n = 206).

The test involves infusing a small amount of insulin into the blood for 3 hours, and simultaneously infusing glucose through another vein. It is designed to maintain blood sugar at a fairly normal level of 100 mg/dL. Glucose uptake in mg/kg lean body mass during the final 40 minutes of the clamp was used to define the level of insulin resistance.

At age 13, none of the children were hypertensive, and the average blood pressure was 109/55 mm Hg in 198 boys and 106/58 mm Hg in 159 girls. Average body mass index (BMI) was 21.6 kg/m2 in boys and 22.3 kg/m2 in girls. At age 19, systolic blood pressure increased by 0.42 mm Hg for each unit increase of insulin resistance from age 13, and it increased by 0.23 mm Hg for each unit increase in BMI from age 13. Triglycerides increased by 1.6 mg/dL for each unit increase in insulin resistance, and by 3.1 mg/dL per each unit increase of BMI from age 13. HDL cholesterol, on the other hand, decreased by 0.30 mg/dL for each unit increase in insulin resistance, and decreased by 0.28 mg/dL for each unit increase in BMI.

Systolic blood pressure changes were independent of those related to BMI and triglyceride levels. All these variables were significantly correlated between the studied ages of 13 and 19 years.

CHICAGO — Insulin resistance in teens increases their risk of high blood pressure as adults, according to a large, longitudinal study reported at a conference of the Council for High Blood Pressure Research.

Insulin resistance was assessed in teens from age 13 to 19 years and was found to be associated with higher systolic blood pressure independent of body mass index, said Alan Sinaiko, M.D., professor of pediatrics at the University of Minnesota in Minneapolis.

“Strategies designed to reduce childhood obesity to prevent atherosclerotic cardiovascular disease and type 2 diabetes may need to be complemented by treatment of insulin resistance,” Dr. Sinaiko said at the meeting, sponsored by the American Heart Association.

Dr. Sinaiko and his colleagues randomly recruited 357 Minneapolis grade school students. Over the next 6 years, the children were tested using a euglycemic hyperinsulinemic clamp at age 13 years (n = 357), at age 15 years (n = 309), and at age 19 years (n = 206).

The test involves infusing a small amount of insulin into the blood for 3 hours, and simultaneously infusing glucose through another vein. It is designed to maintain blood sugar at a fairly normal level of 100 mg/dL. Glucose uptake in mg/kg lean body mass during the final 40 minutes of the clamp was used to define the level of insulin resistance.

At age 13, none of the children were hypertensive, and the average blood pressure was 109/55 mm Hg in 198 boys and 106/58 mm Hg in 159 girls. Average body mass index (BMI) was 21.6 kg/m2 in boys and 22.3 kg/m2 in girls. At age 19, systolic blood pressure increased by 0.42 mm Hg for each unit increase of insulin resistance from age 13, and it increased by 0.23 mm Hg for each unit increase in BMI from age 13. Triglycerides increased by 1.6 mg/dL for each unit increase in insulin resistance, and by 3.1 mg/dL per each unit increase of BMI from age 13. HDL cholesterol, on the other hand, decreased by 0.30 mg/dL for each unit increase in insulin resistance, and decreased by 0.28 mg/dL for each unit increase in BMI.

Systolic blood pressure changes were independent of those related to BMI and triglyceride levels. All these variables were significantly correlated between the studied ages of 13 and 19 years.

CHICAGO — Insulin resistance in teens increases their risk of high blood pressure as adults, according to a large, longitudinal study reported at a conference of the Council for High Blood Pressure Research.

Insulin resistance was assessed in teens from age 13 to 19 years and was found to be associated with higher systolic blood pressure independent of body mass index, said Alan Sinaiko, M.D., professor of pediatrics at the University of Minnesota in Minneapolis.

“Strategies designed to reduce childhood obesity to prevent atherosclerotic cardiovascular disease and type 2 diabetes may need to be complemented by treatment of insulin resistance,” Dr. Sinaiko said at the meeting, sponsored by the American Heart Association.

Dr. Sinaiko and his colleagues randomly recruited 357 Minneapolis grade school students. Over the next 6 years, the children were tested using a euglycemic hyperinsulinemic clamp at age 13 years (n = 357), at age 15 years (n = 309), and at age 19 years (n = 206).

The test involves infusing a small amount of insulin into the blood for 3 hours, and simultaneously infusing glucose through another vein. It is designed to maintain blood sugar at a fairly normal level of 100 mg/dL. Glucose uptake in mg/kg lean body mass during the final 40 minutes of the clamp was used to define the level of insulin resistance.

At age 13, none of the children were hypertensive, and the average blood pressure was 109/55 mm Hg in 198 boys and 106/58 mm Hg in 159 girls. Average body mass index (BMI) was 21.6 kg/m2 in boys and 22.3 kg/m2 in girls. At age 19, systolic blood pressure increased by 0.42 mm Hg for each unit increase of insulin resistance from age 13, and it increased by 0.23 mm Hg for each unit increase in BMI from age 13. Triglycerides increased by 1.6 mg/dL for each unit increase in insulin resistance, and by 3.1 mg/dL per each unit increase of BMI from age 13. HDL cholesterol, on the other hand, decreased by 0.30 mg/dL for each unit increase in insulin resistance, and decreased by 0.28 mg/dL for each unit increase in BMI.

Systolic blood pressure changes were independent of those related to BMI and triglyceride levels. All these variables were significantly correlated between the studied ages of 13 and 19 years.

CHICAGO — A new study suggests that three of the five criteria for inclusion in the pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections, or PANDAS, subgroup could be narrowed and still provide clinically useful benchmarks.

The first criterion for this subgroup is that the children must meet a lifetime diagnostic criterion for obsessive-compulsive disorder (OCD) or a tic disorder, Lisa Snider, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

“Some people are suggesting that anorexia nervosa, attention-deficit hyperactivity disorder, possibly even bipolar disorder could be triggered by infections like streptococcal infection,” Dr. Snider said. “Our research came out of a predisposition to thinking that OCD and tics are secondary to a dysfunction within the basal ganglia.

“Our original research was on patients with Sydenham's chorea, which is triggered by streptococcal infection, and felt to be a basal ganglia disorder.”

The criteria were defined in 1998 by colleague Susan Swedo, M.D., of the National Institute of Mental Health, Bethesda, Md., and have been used successfully to study the pathophysiology and clinical course of the PANDAS subgroup. But, they also have been criticized as being too broad.

PANDAS is now defined by the presence of OCD and/or tic disorder, prepubertal onset, unique clinical course, association of neuropsychiatric symptoms with group A β-hemolytic streptococcal infections, and association with neurologic abnormalities during symptomatic periods.

Dr. Snider and her colleagues suggested the three new criteria should be:

▸ A primary diagnosis of OCD or prominent obsessive-compulsive features (criterion 1).

▸ Abrupt onset of neuropsychiatric symptoms reaching clinical impairment in less than 48 hours or a period of complete neuropsychiatric symptom remission (criterion 2).

▸ A positive throat culture in the 2 months prior to or elevated antistreptococcal titers drawn between 3 weeks and 3 months after neuropsychiatric symptom onset or exacerbation (criterion 3).

“The criteria haven't radically changed, but they are tighter and much more specific, which should help clinicians and researchers,” Dr. Snider told this publication. “If you see someone for the first time, you have a better chance now of saying if this is PANDAS or not, because we don't have a blood test for this disorder.” The study included 30 boys and 20 girls, mean age 8.2 years, who met the original PANDAS criteria. Thirty-eight (76%) had a primary diagnosis of OCD and 12 patients (24%) had a primary diagnosis of tic disorder.

Of the 12 patients with a primary tic disorder, 9 (75%) had comorbid OCD or significant obsessive-compulsive symptoms. Only three patients had a tic disorder without obsessive-compulsive features.

The results were equally clear in regard to criterion 2, Dr. Snider said. Forty-four of the 50 patients (88%) had an abrupt onset of symptoms reaching clinical impairment in less than 48 hours. Of the remaining six patients, four had at least one period of complete symptom remission.

All 50 patients had a group A β-hemolytic streptococcal infection associated with onset or exacerbation. Infection was found in 23% of patients at presentation.

CHICAGO — A new study suggests that three of the five criteria for inclusion in the pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections, or PANDAS, subgroup could be narrowed and still provide clinically useful benchmarks.

The first criterion for this subgroup is that the children must meet a lifetime diagnostic criterion for obsessive-compulsive disorder (OCD) or a tic disorder, Lisa Snider, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

“Some people are suggesting that anorexia nervosa, attention-deficit hyperactivity disorder, possibly even bipolar disorder could be triggered by infections like streptococcal infection,” Dr. Snider said. “Our research came out of a predisposition to thinking that OCD and tics are secondary to a dysfunction within the basal ganglia.

“Our original research was on patients with Sydenham's chorea, which is triggered by streptococcal infection, and felt to be a basal ganglia disorder.”

The criteria were defined in 1998 by colleague Susan Swedo, M.D., of the National Institute of Mental Health, Bethesda, Md., and have been used successfully to study the pathophysiology and clinical course of the PANDAS subgroup. But, they also have been criticized as being too broad.

PANDAS is now defined by the presence of OCD and/or tic disorder, prepubertal onset, unique clinical course, association of neuropsychiatric symptoms with group A β-hemolytic streptococcal infections, and association with neurologic abnormalities during symptomatic periods.

Dr. Snider and her colleagues suggested the three new criteria should be:

▸ A primary diagnosis of OCD or prominent obsessive-compulsive features (criterion 1).

▸ Abrupt onset of neuropsychiatric symptoms reaching clinical impairment in less than 48 hours or a period of complete neuropsychiatric symptom remission (criterion 2).

▸ A positive throat culture in the 2 months prior to or elevated antistreptococcal titers drawn between 3 weeks and 3 months after neuropsychiatric symptom onset or exacerbation (criterion 3).

“The criteria haven't radically changed, but they are tighter and much more specific, which should help clinicians and researchers,” Dr. Snider told this publication. “If you see someone for the first time, you have a better chance now of saying if this is PANDAS or not, because we don't have a blood test for this disorder.” The study included 30 boys and 20 girls, mean age 8.2 years, who met the original PANDAS criteria. Thirty-eight (76%) had a primary diagnosis of OCD and 12 patients (24%) had a primary diagnosis of tic disorder.

Of the 12 patients with a primary tic disorder, 9 (75%) had comorbid OCD or significant obsessive-compulsive symptoms. Only three patients had a tic disorder without obsessive-compulsive features.

The results were equally clear in regard to criterion 2, Dr. Snider said. Forty-four of the 50 patients (88%) had an abrupt onset of symptoms reaching clinical impairment in less than 48 hours. Of the remaining six patients, four had at least one period of complete symptom remission.

All 50 patients had a group A β-hemolytic streptococcal infection associated with onset or exacerbation. Infection was found in 23% of patients at presentation.

CHICAGO — A new study suggests that three of the five criteria for inclusion in the pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections, or PANDAS, subgroup could be narrowed and still provide clinically useful benchmarks.

The first criterion for this subgroup is that the children must meet a lifetime diagnostic criterion for obsessive-compulsive disorder (OCD) or a tic disorder, Lisa Snider, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

“Some people are suggesting that anorexia nervosa, attention-deficit hyperactivity disorder, possibly even bipolar disorder could be triggered by infections like streptococcal infection,” Dr. Snider said. “Our research came out of a predisposition to thinking that OCD and tics are secondary to a dysfunction within the basal ganglia.

“Our original research was on patients with Sydenham's chorea, which is triggered by streptococcal infection, and felt to be a basal ganglia disorder.”

The criteria were defined in 1998 by colleague Susan Swedo, M.D., of the National Institute of Mental Health, Bethesda, Md., and have been used successfully to study the pathophysiology and clinical course of the PANDAS subgroup. But, they also have been criticized as being too broad.

PANDAS is now defined by the presence of OCD and/or tic disorder, prepubertal onset, unique clinical course, association of neuropsychiatric symptoms with group A β-hemolytic streptococcal infections, and association with neurologic abnormalities during symptomatic periods.

Dr. Snider and her colleagues suggested the three new criteria should be:

▸ A primary diagnosis of OCD or prominent obsessive-compulsive features (criterion 1).

▸ Abrupt onset of neuropsychiatric symptoms reaching clinical impairment in less than 48 hours or a period of complete neuropsychiatric symptom remission (criterion 2).

▸ A positive throat culture in the 2 months prior to or elevated antistreptococcal titers drawn between 3 weeks and 3 months after neuropsychiatric symptom onset or exacerbation (criterion 3).

“The criteria haven't radically changed, but they are tighter and much more specific, which should help clinicians and researchers,” Dr. Snider told this publication. “If you see someone for the first time, you have a better chance now of saying if this is PANDAS or not, because we don't have a blood test for this disorder.” The study included 30 boys and 20 girls, mean age 8.2 years, who met the original PANDAS criteria. Thirty-eight (76%) had a primary diagnosis of OCD and 12 patients (24%) had a primary diagnosis of tic disorder.

Of the 12 patients with a primary tic disorder, 9 (75%) had comorbid OCD or significant obsessive-compulsive symptoms. Only three patients had a tic disorder without obsessive-compulsive features.

The results were equally clear in regard to criterion 2, Dr. Snider said. Forty-four of the 50 patients (88%) had an abrupt onset of symptoms reaching clinical impairment in less than 48 hours. Of the remaining six patients, four had at least one period of complete symptom remission.

All 50 patients had a group A β-hemolytic streptococcal infection associated with onset or exacerbation. Infection was found in 23% of patients at presentation.

CHICAGO — Waist circumference appears to be an important and previously unrecognized indicator of knee osteoarthritis risk in men, Lauren M. Abbate reported at the 2004 World Congress on Osteoarthritis.

Men with a waist circumference greater than 108 cm were twice as likely to have osteoarthritis of the knee than were men with a waist circumference less than 95 cm, according to findings from the Johnston County Osteoarthritis Project, which involved a randomly selected group of 849 women and 458 men from Johnston County in North Carolina.

Among women there was a stronger association between body mass index (BMI) or weight and knee compared with men, added Ms. Abbate, an epidemiology doctoral student at the University of North Carolina at Chapel Hill.

Large waist circumference among women was associated with an increased risk of knee osteoarthritis in the study, but not independently of BMI.

This finding is similar to data reported from the population-based Chingford Study, she said.

Previous osteoarthritis studies have shown that the effect of BMI differs by gender, but have not evaluated the effect using measures of body fat distribution or composition.

Investigators at the University of North Carolina's Thurston Arthritis Research Center assessed body composition using dual-energy x-ray absorptiometry (DXA), and assessed body fat distribution using waist and hip circumferences.

Radiographic knee osteoarthritis was defined as a Kellgren-Lawrence grade of 2 or more, Ms. Abbate said.

The mean age of the participants was 65 years for both men and women, 27% of the women and 16% of the men were African American.

In women, the mean BMI was 30 kg/m2 and mean weight was 77 kg, and in men, mean BMI was 29 kg/m2 and mean weight 89 kg.

Body composition variables associated with higher odds of knee osteoarthritis in women included fat mass (OR 4.47), percent fat mass (OR 3.25), and lean mass (OR 3.18).

By contrast, in men, waist circumference was the only variable significantly associated with the knee osteoarthritis (2.47). Waist size was also significantly associated with the disease in women (OR 4.33).

Waist-to-hip ratio was not significantly associated with knee osteoarthritis in women (OR 1.56) or men (OR 1.21).

After adjustment for BMI, none of the associations with body composition or body fat distribution variables and knee osteoarthritis in women remained significant.

Waist circumference in men, however, remained a statistically significant predictor of knee osteoarthritis (OR 3.46), Ms. Abbate said.

The findings underscore the importance of weight management for osteoarthritis, particularly, Ms. Abbate said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

Waist circumference in men is a previously overlooked risk factor for knee osteoarthritis, above and beyond BMI, said senior author and UNC associate professor of medicine Joanne M. Jordan, M.D.

“This study suggests that in women, BMI is highly associated with radiographic knee osteoarthritis, and that other measures of obesity such as body composition may not be necessary beyond BMI,” Dr. Jordan said. “It also suggests that BMI may not be the best measurement of obesity when assessing risk among men, and that we should investigate the waist circumference measurements in more detail,” she said.

Waist circumference is garnering attention in the cardiovascular literature, where studies suggest that it is increasingly replacing BMI as the preferred indicator of obesity-related cardiovascular risk.

CHICAGO — Waist circumference appears to be an important and previously unrecognized indicator of knee osteoarthritis risk in men, Lauren M. Abbate reported at the 2004 World Congress on Osteoarthritis.

Men with a waist circumference greater than 108 cm were twice as likely to have osteoarthritis of the knee than were men with a waist circumference less than 95 cm, according to findings from the Johnston County Osteoarthritis Project, which involved a randomly selected group of 849 women and 458 men from Johnston County in North Carolina.

Among women there was a stronger association between body mass index (BMI) or weight and knee compared with men, added Ms. Abbate, an epidemiology doctoral student at the University of North Carolina at Chapel Hill.

Large waist circumference among women was associated with an increased risk of knee osteoarthritis in the study, but not independently of BMI.

This finding is similar to data reported from the population-based Chingford Study, she said.

Previous osteoarthritis studies have shown that the effect of BMI differs by gender, but have not evaluated the effect using measures of body fat distribution or composition.

Investigators at the University of North Carolina's Thurston Arthritis Research Center assessed body composition using dual-energy x-ray absorptiometry (DXA), and assessed body fat distribution using waist and hip circumferences.

Radiographic knee osteoarthritis was defined as a Kellgren-Lawrence grade of 2 or more, Ms. Abbate said.

The mean age of the participants was 65 years for both men and women, 27% of the women and 16% of the men were African American.

In women, the mean BMI was 30 kg/m2 and mean weight was 77 kg, and in men, mean BMI was 29 kg/m2 and mean weight 89 kg.

Body composition variables associated with higher odds of knee osteoarthritis in women included fat mass (OR 4.47), percent fat mass (OR 3.25), and lean mass (OR 3.18).

By contrast, in men, waist circumference was the only variable significantly associated with the knee osteoarthritis (2.47). Waist size was also significantly associated with the disease in women (OR 4.33).

Waist-to-hip ratio was not significantly associated with knee osteoarthritis in women (OR 1.56) or men (OR 1.21).

After adjustment for BMI, none of the associations with body composition or body fat distribution variables and knee osteoarthritis in women remained significant.

Waist circumference in men, however, remained a statistically significant predictor of knee osteoarthritis (OR 3.46), Ms. Abbate said.

The findings underscore the importance of weight management for osteoarthritis, particularly, Ms. Abbate said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

Waist circumference in men is a previously overlooked risk factor for knee osteoarthritis, above and beyond BMI, said senior author and UNC associate professor of medicine Joanne M. Jordan, M.D.

“This study suggests that in women, BMI is highly associated with radiographic knee osteoarthritis, and that other measures of obesity such as body composition may not be necessary beyond BMI,” Dr. Jordan said. “It also suggests that BMI may not be the best measurement of obesity when assessing risk among men, and that we should investigate the waist circumference measurements in more detail,” she said.

Waist circumference is garnering attention in the cardiovascular literature, where studies suggest that it is increasingly replacing BMI as the preferred indicator of obesity-related cardiovascular risk.

CHICAGO — Waist circumference appears to be an important and previously unrecognized indicator of knee osteoarthritis risk in men, Lauren M. Abbate reported at the 2004 World Congress on Osteoarthritis.

Men with a waist circumference greater than 108 cm were twice as likely to have osteoarthritis of the knee than were men with a waist circumference less than 95 cm, according to findings from the Johnston County Osteoarthritis Project, which involved a randomly selected group of 849 women and 458 men from Johnston County in North Carolina.

Among women there was a stronger association between body mass index (BMI) or weight and knee compared with men, added Ms. Abbate, an epidemiology doctoral student at the University of North Carolina at Chapel Hill.

Large waist circumference among women was associated with an increased risk of knee osteoarthritis in the study, but not independently of BMI.

This finding is similar to data reported from the population-based Chingford Study, she said.

Previous osteoarthritis studies have shown that the effect of BMI differs by gender, but have not evaluated the effect using measures of body fat distribution or composition.

Investigators at the University of North Carolina's Thurston Arthritis Research Center assessed body composition using dual-energy x-ray absorptiometry (DXA), and assessed body fat distribution using waist and hip circumferences.

Radiographic knee osteoarthritis was defined as a Kellgren-Lawrence grade of 2 or more, Ms. Abbate said.

The mean age of the participants was 65 years for both men and women, 27% of the women and 16% of the men were African American.

In women, the mean BMI was 30 kg/m2 and mean weight was 77 kg, and in men, mean BMI was 29 kg/m2 and mean weight 89 kg.

Body composition variables associated with higher odds of knee osteoarthritis in women included fat mass (OR 4.47), percent fat mass (OR 3.25), and lean mass (OR 3.18).

By contrast, in men, waist circumference was the only variable significantly associated with the knee osteoarthritis (2.47). Waist size was also significantly associated with the disease in women (OR 4.33).

Waist-to-hip ratio was not significantly associated with knee osteoarthritis in women (OR 1.56) or men (OR 1.21).

After adjustment for BMI, none of the associations with body composition or body fat distribution variables and knee osteoarthritis in women remained significant.

Waist circumference in men, however, remained a statistically significant predictor of knee osteoarthritis (OR 3.46), Ms. Abbate said.

The findings underscore the importance of weight management for osteoarthritis, particularly, Ms. Abbate said at the meeting, which was sponsored by the Osteoarthritis Research Society International.

Waist circumference in men is a previously overlooked risk factor for knee osteoarthritis, above and beyond BMI, said senior author and UNC associate professor of medicine Joanne M. Jordan, M.D.

“This study suggests that in women, BMI is highly associated with radiographic knee osteoarthritis, and that other measures of obesity such as body composition may not be necessary beyond BMI,” Dr. Jordan said. “It also suggests that BMI may not be the best measurement of obesity when assessing risk among men, and that we should investigate the waist circumference measurements in more detail,” she said.

Waist circumference is garnering attention in the cardiovascular literature, where studies suggest that it is increasingly replacing BMI as the preferred indicator of obesity-related cardiovascular risk.

CHICAGO — Musculoskeletal symptoms are very common in the morbidly obese, but improve significantly as early as 6 months after gastric bypass surgery, Michele Hooper, M.D., said at the 2004 World Congress on Osteoarthritis.

In a study of 48 consecutive patients, 52% had complete resolution of musculoskeletal symptoms, in weight bearing and non-weight bearing sites, 6 months after surgery. Fibromyalgia symptoms resolved in 90% of patients.

Such benefits may even become more pronounced with time, as weight loss generally plateaus at 24 months and many of the patients were still obese at the time of the study.

While these highly motivated patients may not reflect the general obese population, the benefits seen with weight loss indicate that prevention and treatment of obesity could improve musculoskeletal health and function, said Dr. Hooper of University Hospitals of Cleveland.

She reported on 47 women and one man, mean age 44 years, who were evaluated before and 6 months after laparoscopic or open Roux-en-Y surgery. The mean weight of the women before surgery was 292 pounds (body mass index 51 kg/m

The percentage of patients with comorbid conditions at baseline decreased after weight loss: hypertension (52% vs. 14%), sleep apnea (46% vs. 14%), depression (33% vs. 14%), gastroesophageal reflux disease (31% vs. 11%), type 2 diabetes (30% vs. 7%), and asthma (30% vs. 7%). Ninety percent of fibromyalgia symptoms resolved.

The dramatic resolution of fibromyalgia symptoms may be due to a decrease in comorbid syndromes, particularly depression, and an increase in physical activity, Dr. Hooper said at the meeting.

Lower extremity symptoms improved with weight loss, with the exception of hip and trochanteric bursitis complaints. Upper extremity symptoms improved, with the exception of epicondylitis.

The proportion of patients affected by symptoms decreased significantly as follows: knee symptoms (75% at baseline vs. 44% after weight loss), ankle/foot (46% vs. 8%), shoulder (40% vs. 27%), lumbar spine (38% vs. 15%), hand (35% vs. 21%), carpal tunnel syndrome (31% vs. 15%), hip joint (23% vs. 15%), trochanteric bursitis (29% vs. 17%), and epicondylitis (13% vs. 4%).

At 6 months, scores on the Western Ontario and McMaster University Osteoarthritis (WOMAC) composite index improved 67% from baseline. WOMAC subscales improved for pain (51%), function (74%), and stiffness (64%).

Short Form-36 Health Survey scores significantly improved in seven of eight domains measured, and the remaining one domain, general health, was close to normal at baseline.

“The WOMAC osteoarthritis index offers significant potential for assessing musculoskeletal outcomes in obese subjects after gastric bypass surgery, and should be explored further,” Dr. Hooper said. “The SF indicates that obesity is associated with a poor quality of life, which improves significantly after weight loss associated with gastric bypass surgery.”

CHICAGO — Musculoskeletal symptoms are very common in the morbidly obese, but improve significantly as early as 6 months after gastric bypass surgery, Michele Hooper, M.D., said at the 2004 World Congress on Osteoarthritis.

In a study of 48 consecutive patients, 52% had complete resolution of musculoskeletal symptoms, in weight bearing and non-weight bearing sites, 6 months after surgery. Fibromyalgia symptoms resolved in 90% of patients.

Such benefits may even become more pronounced with time, as weight loss generally plateaus at 24 months and many of the patients were still obese at the time of the study.

While these highly motivated patients may not reflect the general obese population, the benefits seen with weight loss indicate that prevention and treatment of obesity could improve musculoskeletal health and function, said Dr. Hooper of University Hospitals of Cleveland.

She reported on 47 women and one man, mean age 44 years, who were evaluated before and 6 months after laparoscopic or open Roux-en-Y surgery. The mean weight of the women before surgery was 292 pounds (body mass index 51 kg/m

The percentage of patients with comorbid conditions at baseline decreased after weight loss: hypertension (52% vs. 14%), sleep apnea (46% vs. 14%), depression (33% vs. 14%), gastroesophageal reflux disease (31% vs. 11%), type 2 diabetes (30% vs. 7%), and asthma (30% vs. 7%). Ninety percent of fibromyalgia symptoms resolved.

The dramatic resolution of fibromyalgia symptoms may be due to a decrease in comorbid syndromes, particularly depression, and an increase in physical activity, Dr. Hooper said at the meeting.

Lower extremity symptoms improved with weight loss, with the exception of hip and trochanteric bursitis complaints. Upper extremity symptoms improved, with the exception of epicondylitis.

The proportion of patients affected by symptoms decreased significantly as follows: knee symptoms (75% at baseline vs. 44% after weight loss), ankle/foot (46% vs. 8%), shoulder (40% vs. 27%), lumbar spine (38% vs. 15%), hand (35% vs. 21%), carpal tunnel syndrome (31% vs. 15%), hip joint (23% vs. 15%), trochanteric bursitis (29% vs. 17%), and epicondylitis (13% vs. 4%).

At 6 months, scores on the Western Ontario and McMaster University Osteoarthritis (WOMAC) composite index improved 67% from baseline. WOMAC subscales improved for pain (51%), function (74%), and stiffness (64%).

Short Form-36 Health Survey scores significantly improved in seven of eight domains measured, and the remaining one domain, general health, was close to normal at baseline.

“The WOMAC osteoarthritis index offers significant potential for assessing musculoskeletal outcomes in obese subjects after gastric bypass surgery, and should be explored further,” Dr. Hooper said. “The SF indicates that obesity is associated with a poor quality of life, which improves significantly after weight loss associated with gastric bypass surgery.”

CHICAGO — Musculoskeletal symptoms are very common in the morbidly obese, but improve significantly as early as 6 months after gastric bypass surgery, Michele Hooper, M.D., said at the 2004 World Congress on Osteoarthritis.

In a study of 48 consecutive patients, 52% had complete resolution of musculoskeletal symptoms, in weight bearing and non-weight bearing sites, 6 months after surgery. Fibromyalgia symptoms resolved in 90% of patients.

Such benefits may even become more pronounced with time, as weight loss generally plateaus at 24 months and many of the patients were still obese at the time of the study.

While these highly motivated patients may not reflect the general obese population, the benefits seen with weight loss indicate that prevention and treatment of obesity could improve musculoskeletal health and function, said Dr. Hooper of University Hospitals of Cleveland.

She reported on 47 women and one man, mean age 44 years, who were evaluated before and 6 months after laparoscopic or open Roux-en-Y surgery. The mean weight of the women before surgery was 292 pounds (body mass index 51 kg/m

The percentage of patients with comorbid conditions at baseline decreased after weight loss: hypertension (52% vs. 14%), sleep apnea (46% vs. 14%), depression (33% vs. 14%), gastroesophageal reflux disease (31% vs. 11%), type 2 diabetes (30% vs. 7%), and asthma (30% vs. 7%). Ninety percent of fibromyalgia symptoms resolved.

The dramatic resolution of fibromyalgia symptoms may be due to a decrease in comorbid syndromes, particularly depression, and an increase in physical activity, Dr. Hooper said at the meeting.

Lower extremity symptoms improved with weight loss, with the exception of hip and trochanteric bursitis complaints. Upper extremity symptoms improved, with the exception of epicondylitis.

The proportion of patients affected by symptoms decreased significantly as follows: knee symptoms (75% at baseline vs. 44% after weight loss), ankle/foot (46% vs. 8%), shoulder (40% vs. 27%), lumbar spine (38% vs. 15%), hand (35% vs. 21%), carpal tunnel syndrome (31% vs. 15%), hip joint (23% vs. 15%), trochanteric bursitis (29% vs. 17%), and epicondylitis (13% vs. 4%).

At 6 months, scores on the Western Ontario and McMaster University Osteoarthritis (WOMAC) composite index improved 67% from baseline. WOMAC subscales improved for pain (51%), function (74%), and stiffness (64%).

Short Form-36 Health Survey scores significantly improved in seven of eight domains measured, and the remaining one domain, general health, was close to normal at baseline.

“The WOMAC osteoarthritis index offers significant potential for assessing musculoskeletal outcomes in obese subjects after gastric bypass surgery, and should be explored further,” Dr. Hooper said. “The SF indicates that obesity is associated with a poor quality of life, which improves significantly after weight loss associated with gastric bypass surgery.”

CHICAGO — Preliminary findings suggest that the Pediatric Symptom Checklist can identify high rates of posttraumatic stress disorder among children, but that results vary depending on whether a child or parent completes the checklist.

Based upon parental responses to the Pediatric Symptom Checklist (PSC), 25% of 72 children evaluated in a New York City practice had positive screens for general psychosocial dysfunction. But when the children completed the youth-PSC, 33% had positive screens. This suggests that parents and children have very different perceptions of a child's level of distress, Deborah Steinbaum, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

The sensitivity for detecting children with likely posttraumatic stress disorder (PTSD) was 58% for the youth-PSC and 33% for the parent-PSC. When the cutoff for a positive youth-PSC screen was lowered from 30 to 28—as has been done in some studies—the sensitivity of the screen rose to 83%, Dr. Steinbaum said. Specificity was about 70%.

“The parent-PSC didn't do so well because it identified fewer of the likely PTSD children than would have been identified by a coin toss,” said Dr. Steinbaum of Mount Sinai Medical Center, New York. “A lot of the research [on] the PSC has been based on the parent report, so to me this is an important thing to keep in our minds.”

The ongoing study is following 72 children, aged 8-10 years, seen at the Pediatric Associates Practice at Mount Sinai. The mean age was 9.1 years, 57% were female, and 52% had ongoing medical problems such as asthma (30%) or allergies (11%).

One-fourth of caregivers said their child had an ongoing emotional or behavioral problem, and 28% said their child had seen a mental health professional—defined broadly as a counselor, social worker, psychologist, or psychiatrist—in the previous year. Most of the caregivers (60%) defined themselves as Latino or Hispanic.

Screens were considered positive if they had scores of at least 30 on the youth-PSC and at least 28 on the parent-PSC. A positive score on the 35-item PSC checklist is thought to have a sensitivity of 95% and a specificity of 68%.

A score of at least 38 on the 45-item University of California, Los Angeles, Posttraumatic Stress Reaction Index (PTSRI) indicates likely PTSD and is thought to be 93% sensitive and 87% specific.

The PTSRI identified 16% of children in the study group as positive, which means they probably had PTSD, Dr. Steinbaum said. The rate of PTSD in the general pediatric population is unknown. However, the results are from an inner-city population and can't be generalized to the community at large.

Overall, Dr. Steinbaum said the study population had high rates of psychosocial dysfunction, possibly higher than other studied groups, and exhibited high rates of trauma exposure and subsequent distress.

Almost all of the children in the study reported experiencing one or more major traumatic events, such as bullying, domestic violence, sexual abuse, or witnessing a shooting. Despite these experiences, the children did not commonly identify very violent or frightening events as their primary trauma on the PTSRI, but instead listed events such as a grandmother's death. However, bullying did affect a significant number of children with higher PTSRI scores.

CHICAGO — Preliminary findings suggest that the Pediatric Symptom Checklist can identify high rates of posttraumatic stress disorder among children, but that results vary depending on whether a child or parent completes the checklist.

Based upon parental responses to the Pediatric Symptom Checklist (PSC), 25% of 72 children evaluated in a New York City practice had positive screens for general psychosocial dysfunction. But when the children completed the youth-PSC, 33% had positive screens. This suggests that parents and children have very different perceptions of a child's level of distress, Deborah Steinbaum, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

The sensitivity for detecting children with likely posttraumatic stress disorder (PTSD) was 58% for the youth-PSC and 33% for the parent-PSC. When the cutoff for a positive youth-PSC screen was lowered from 30 to 28—as has been done in some studies—the sensitivity of the screen rose to 83%, Dr. Steinbaum said. Specificity was about 70%.

“The parent-PSC didn't do so well because it identified fewer of the likely PTSD children than would have been identified by a coin toss,” said Dr. Steinbaum of Mount Sinai Medical Center, New York. “A lot of the research [on] the PSC has been based on the parent report, so to me this is an important thing to keep in our minds.”

The ongoing study is following 72 children, aged 8-10 years, seen at the Pediatric Associates Practice at Mount Sinai. The mean age was 9.1 years, 57% were female, and 52% had ongoing medical problems such as asthma (30%) or allergies (11%).

One-fourth of caregivers said their child had an ongoing emotional or behavioral problem, and 28% said their child had seen a mental health professional—defined broadly as a counselor, social worker, psychologist, or psychiatrist—in the previous year. Most of the caregivers (60%) defined themselves as Latino or Hispanic.

Screens were considered positive if they had scores of at least 30 on the youth-PSC and at least 28 on the parent-PSC. A positive score on the 35-item PSC checklist is thought to have a sensitivity of 95% and a specificity of 68%.

A score of at least 38 on the 45-item University of California, Los Angeles, Posttraumatic Stress Reaction Index (PTSRI) indicates likely PTSD and is thought to be 93% sensitive and 87% specific.

The PTSRI identified 16% of children in the study group as positive, which means they probably had PTSD, Dr. Steinbaum said. The rate of PTSD in the general pediatric population is unknown. However, the results are from an inner-city population and can't be generalized to the community at large.

Overall, Dr. Steinbaum said the study population had high rates of psychosocial dysfunction, possibly higher than other studied groups, and exhibited high rates of trauma exposure and subsequent distress.

Almost all of the children in the study reported experiencing one or more major traumatic events, such as bullying, domestic violence, sexual abuse, or witnessing a shooting. Despite these experiences, the children did not commonly identify very violent or frightening events as their primary trauma on the PTSRI, but instead listed events such as a grandmother's death. However, bullying did affect a significant number of children with higher PTSRI scores.

CHICAGO — Preliminary findings suggest that the Pediatric Symptom Checklist can identify high rates of posttraumatic stress disorder among children, but that results vary depending on whether a child or parent completes the checklist.

Based upon parental responses to the Pediatric Symptom Checklist (PSC), 25% of 72 children evaluated in a New York City practice had positive screens for general psychosocial dysfunction. But when the children completed the youth-PSC, 33% had positive screens. This suggests that parents and children have very different perceptions of a child's level of distress, Deborah Steinbaum, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

The sensitivity for detecting children with likely posttraumatic stress disorder (PTSD) was 58% for the youth-PSC and 33% for the parent-PSC. When the cutoff for a positive youth-PSC screen was lowered from 30 to 28—as has been done in some studies—the sensitivity of the screen rose to 83%, Dr. Steinbaum said. Specificity was about 70%.

“The parent-PSC didn't do so well because it identified fewer of the likely PTSD children than would have been identified by a coin toss,” said Dr. Steinbaum of Mount Sinai Medical Center, New York. “A lot of the research [on] the PSC has been based on the parent report, so to me this is an important thing to keep in our minds.”

The ongoing study is following 72 children, aged 8-10 years, seen at the Pediatric Associates Practice at Mount Sinai. The mean age was 9.1 years, 57% were female, and 52% had ongoing medical problems such as asthma (30%) or allergies (11%).

One-fourth of caregivers said their child had an ongoing emotional or behavioral problem, and 28% said their child had seen a mental health professional—defined broadly as a counselor, social worker, psychologist, or psychiatrist—in the previous year. Most of the caregivers (60%) defined themselves as Latino or Hispanic.

Screens were considered positive if they had scores of at least 30 on the youth-PSC and at least 28 on the parent-PSC. A positive score on the 35-item PSC checklist is thought to have a sensitivity of 95% and a specificity of 68%.

A score of at least 38 on the 45-item University of California, Los Angeles, Posttraumatic Stress Reaction Index (PTSRI) indicates likely PTSD and is thought to be 93% sensitive and 87% specific.

The PTSRI identified 16% of children in the study group as positive, which means they probably had PTSD, Dr. Steinbaum said. The rate of PTSD in the general pediatric population is unknown. However, the results are from an inner-city population and can't be generalized to the community at large.

Overall, Dr. Steinbaum said the study population had high rates of psychosocial dysfunction, possibly higher than other studied groups, and exhibited high rates of trauma exposure and subsequent distress.

Almost all of the children in the study reported experiencing one or more major traumatic events, such as bullying, domestic violence, sexual abuse, or witnessing a shooting. Despite these experiences, the children did not commonly identify very violent or frightening events as their primary trauma on the PTSRI, but instead listed events such as a grandmother's death. However, bullying did affect a significant number of children with higher PTSRI scores.

CHICAGO — Physicians can screen for academic problems in school-age children by asking parents a simple question, Jeffrey P. Brosco, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Asking parents explicitly, “Do you have any concerns about how your child is learning in school?” was a more sensitive screener than the Pediatric Symptom Checklist (PSC), a new study showed.

Even specific questions about academic performance on the PSC were less sensitive than the single question.

Primary care medical providers typically rely on informal caregiver reports to screen for school academic problems. Many doctors ask parents, “How is your child doing in school?” only to get the response, “fine,” said Dr. Brosco of the Mailman Center for Child Development at the University of Miami.

“We're particularly interested because we often see, as I'm sure many of you do, the 12- or the 13-year-old who has inattentive [attention-deficit hyperactivity disorder] or a reading disorder, and he or she has made it along for years barely getting by because they don't act out or create a lot of problems in school,” Dr. Brosco said.

A total of 51 parent-child pairs, recruited from a university general pediatrics practice and a county hospital general pediatrics clinic in urban Miami, completed the PSC and a questionnaire that included 15 screening questions about school and general health. School information was obtained directly from the school.

The children's mean age was 9 years, 41% were male, and the majority of children were identified by their parents as African American or Hispanic. The primary languages at home were English, Spanish, and French or French Creole

The question was drawn from Parents' Evaluation of Developmental Status (PEDS), a standardized, validated, and copyrighted screening test (www.pedstest.com

Fifty-six percent of parents answered “yes,” that they had concerns about how their child was learning at school. The sensitivity was 72.4% and specificity 52.2%.

Academic problems actually occurred in 21 children, defined as a cumulative grade point average in core subjects below 2.5.

Two other questions had similar sensitivity; asking parents whether they had concerns about a child's behavior in school (sensitivity 69%, specificity 56.5%), and asking parents whether a teacher had concerns about their child (sensitivity 74.1%, specificity 69.6%). A total PSC score of 26 or greater was not a sensitive measure of school academic problems (sensitivity 31%, specificity 86%).

There was no difference in responses by socioeconomic status, and the results were inconclusive as to the impact of the language spoken in the home.

CHICAGO — Physicians can screen for academic problems in school-age children by asking parents a simple question, Jeffrey P. Brosco, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Asking parents explicitly, “Do you have any concerns about how your child is learning in school?” was a more sensitive screener than the Pediatric Symptom Checklist (PSC), a new study showed.

Even specific questions about academic performance on the PSC were less sensitive than the single question.

Primary care medical providers typically rely on informal caregiver reports to screen for school academic problems. Many doctors ask parents, “How is your child doing in school?” only to get the response, “fine,” said Dr. Brosco of the Mailman Center for Child Development at the University of Miami.

“We're particularly interested because we often see, as I'm sure many of you do, the 12- or the 13-year-old who has inattentive [attention-deficit hyperactivity disorder] or a reading disorder, and he or she has made it along for years barely getting by because they don't act out or create a lot of problems in school,” Dr. Brosco said.

A total of 51 parent-child pairs, recruited from a university general pediatrics practice and a county hospital general pediatrics clinic in urban Miami, completed the PSC and a questionnaire that included 15 screening questions about school and general health. School information was obtained directly from the school.

The children's mean age was 9 years, 41% were male, and the majority of children were identified by their parents as African American or Hispanic. The primary languages at home were English, Spanish, and French or French Creole

The question was drawn from Parents' Evaluation of Developmental Status (PEDS), a standardized, validated, and copyrighted screening test (www.pedstest.com

Fifty-six percent of parents answered “yes,” that they had concerns about how their child was learning at school. The sensitivity was 72.4% and specificity 52.2%.

Academic problems actually occurred in 21 children, defined as a cumulative grade point average in core subjects below 2.5.

Two other questions had similar sensitivity; asking parents whether they had concerns about a child's behavior in school (sensitivity 69%, specificity 56.5%), and asking parents whether a teacher had concerns about their child (sensitivity 74.1%, specificity 69.6%). A total PSC score of 26 or greater was not a sensitive measure of school academic problems (sensitivity 31%, specificity 86%).

There was no difference in responses by socioeconomic status, and the results were inconclusive as to the impact of the language spoken in the home.

CHICAGO — Physicians can screen for academic problems in school-age children by asking parents a simple question, Jeffrey P. Brosco, M.D., said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Asking parents explicitly, “Do you have any concerns about how your child is learning in school?” was a more sensitive screener than the Pediatric Symptom Checklist (PSC), a new study showed.

Even specific questions about academic performance on the PSC were less sensitive than the single question.

Primary care medical providers typically rely on informal caregiver reports to screen for school academic problems. Many doctors ask parents, “How is your child doing in school?” only to get the response, “fine,” said Dr. Brosco of the Mailman Center for Child Development at the University of Miami.

“We're particularly interested because we often see, as I'm sure many of you do, the 12- or the 13-year-old who has inattentive [attention-deficit hyperactivity disorder] or a reading disorder, and he or she has made it along for years barely getting by because they don't act out or create a lot of problems in school,” Dr. Brosco said.

A total of 51 parent-child pairs, recruited from a university general pediatrics practice and a county hospital general pediatrics clinic in urban Miami, completed the PSC and a questionnaire that included 15 screening questions about school and general health. School information was obtained directly from the school.

The children's mean age was 9 years, 41% were male, and the majority of children were identified by their parents as African American or Hispanic. The primary languages at home were English, Spanish, and French or French Creole

The question was drawn from Parents' Evaluation of Developmental Status (PEDS), a standardized, validated, and copyrighted screening test (www.pedstest.com

Fifty-six percent of parents answered “yes,” that they had concerns about how their child was learning at school. The sensitivity was 72.4% and specificity 52.2%.

Academic problems actually occurred in 21 children, defined as a cumulative grade point average in core subjects below 2.5.

Two other questions had similar sensitivity; asking parents whether they had concerns about a child's behavior in school (sensitivity 69%, specificity 56.5%), and asking parents whether a teacher had concerns about their child (sensitivity 74.1%, specificity 69.6%). A total PSC score of 26 or greater was not a sensitive measure of school academic problems (sensitivity 31%, specificity 86%).

There was no difference in responses by socioeconomic status, and the results were inconclusive as to the impact of the language spoken in the home.

The use of physical and chemical restraints remains a thorny issue, despite great strides that are being made to improve, reduce, and eliminate the practice.

An investigative series by the Hartford Courant in 1998 prompted a federal investigation and report confirming that the use of seclusion and restraint was largely ungoverned, erratically monitored, and underreported, and had caused injury and death to both children and adults.

That same report from the U.S. General Accounting Office (now known as the Government Accountability Office) went on to say that some states had been able to reduce–and even eliminate–seclusion and restraint use. Just how clinicians are expected to accomplish that is the topic of much debate and little scientific research.

Eliminating the use of restraints in the emergency department, for example, isn't possible because, by its very nature, the ED isn't as controlled a setting as are other units, said Douglas Kupas, M.D., director of the emergency residency program at Geisinger Medical Center, Danville, Pa. Emergency departments have to consider the safety of the patient, staff, and other patients who are often in close proximity.

“Although there are deaths in patients who have been restrained, the restraint frequently has nothing to do with the cause of death. We must always work to improve our training and to use best practices when restraining patients, but many emergency medical services systems and EDs do an excellent job in restraining these very difficult patients,” he said.

Patients should be restrained in a way that maintains their dignity and permits evaluation of underlying medical conditions, he said. The staff needs both to be educated on the use of verbal de-escalation and physical and chemical restraints, and to be prepared to use the appropriate techniques.

To point to a single practice as hazardous oversimplifies the issue, Dr. Kupas said.

In particular, critics posit that restraining patients in the prone position predisposes them to suffocation. Although his practice is to avoid the prone position, Dr. Kupas said it can be helpful in the initial restraint or “take-down” of a patient.

“The key is that [restraint] is multifaceted,” he said. “There isn't a silver bullet answer, but there are many best practices that EDs should incorporate into their policies and procedures.”

Educating staff about the appropriate time to administer and remove restraints is essential, agrees David H. Dorfman, M.D., a pediatrician with the division of pediatric emergency medicine at Boston Medical Center and the department of pediatrics at Boston University.

A study led by Dr. Dorfman found that a large percentage of emergency medicine residency programs (52% of 48 respondents) and pediatric emergency medicine fellowships (82% of 33 respondents) do not teach their trainees about the application of restraints, and 35% of responding emergency medicine residencies and 64% of pediatric emergency medicine fellowships did not teach appropriate situations in which to use restraints (Pediatr. Emerg. Care 2004;20:151–6).

Chemical restraints were used in pediatric psychiatric patients in the emergency department by almost three-fourths of the respondents, but few reported having formal policies on chemical restraint.

Benzodiazepines and butyrophenones were the most commonly used agents. But both responding groups often misclassified butyrophenones as phenothiazines.

Cascading to Arrhythmia

A situation ripe for improvement is the misinterpretation of the cascade of events leading to fatal arrhythmias, particularly when patients are restrained in the prone position, said Tracy G. Sanson, M.D., assistant medical director in the department of emergency medicine at Brandon (Fla.) Regional Hospital.

In a typical scenario, a patient may be brought in by police, handcuffed to a bed after being chased for 10 blocks for selling cocaine, and administered a second intramuscular injection under restraints because nothing else is working, she said. Staff or police may increase the pressure of their hold until the patient stops resisting, at which point they assume either that the patient is “playing possum” or that the medication has taken effect.

“Essentially that is the [moment]–if you would recognize it–that if you flipped them over, defibrillated them, [and] gave them bicarb and fluids, you could get them back,” Dr. Sanson said.

The actual causes of cocaine-associated sudden death and excited delirium are unknown. But studies have suggested that the vast majority of such patients die after a struggle, which may increase the level of circulating epinephrine and may result in metabolic acidosis.

In the ED, chemical restraint should be used more aggressively, Dr. Sanson said. It must be accompanied by ongoing monitoring because of the risk of respiratory arrest and because of the cumulative effect of drugs that may have been used by the patient prior to arrival and/or those administered by ED staff.

A prospective study found that chemical restraint was added to only 28% of 298 consecutive patients restrained in an inner-city teaching hospital ED over a 1-year period (J. Emerg. Med. 2003;24:119–24). Patients were most frequently restrained on a cart with two physical restraints (59%), in the supine position (86%), with a low rate of minor complications (7%).

The federal requirement for face-to-face physician evaluation of an individual in restraints within 1 hour of the event has strengthened the focus on the safer use of seclusion and restraint. But there is no evidence that the “1-hour rule” has made restraint a safer intervention or changed practice since it was established in 1999, said Kevin Ann Huckshorn, R.N., director of the office of technical assistance for the National Association of State Mental Heath Program Directors (NASMHPD).

Promoting Prevention

NASMHPD has joined with others in calling for the application of the public health prevention model of primary, secondary, and tertiary prevention interventions to the practice of seclusion and restraint.

Primary prevention works to create an administrative and clinical treatment environment that minimizes the development of conflict.

Secondary interventions–such as comfort rooms and staff training on attitudes and behaviors in conflict settings–are focused on mitigating conflict or aggression once it occurs. Tertiary preventions address the most effective ways to mitigate damage done to patients, staff, and others who witness a seclusion and restraint event. An example is an event debriefing of all witnesses and the patient, with rigorous problem-solving activities.

Although participation by the private sector has been slow, public health care providers from all but two states have gone through NASMHPD's 21/2-day training sessions since they began in 2003. The sessions highlight six core strategies: leadership training, use of data, workforce development, prevention tools, consumer roles, and debriefing tools.

“Some states have really taken it on board,” Ms. Huckshorn said. “It's one thing to get an 'ah-ha moment,' but this was brilliant.”

The large-scale evaluation of the training will take place this year in an attempt to build an evidence-based practice, because “that is how you change clinical practice standards,” Ms. Huckshorn said.

The adoption of the Oregon model program, which also has prevention at its core, has virtually eliminated the use of seclusion and restraint in the psychiatric inpatient unit at Salem (Ore.) Hospital, said Maggie Bennington-Davis, M.D., medical director of the 24-bed, adult locked unit.

The model uses the basic tenets of the neurobiology of trauma and the development of community as set forth by author Sandra L. Bloom. The Salem team eliminated any rule that was based on staff convenience or that created a power struggle, and adopted an attitude based on patient satisfaction.

They created a social structure in which everyone is assumed to be respectful of the physical surroundings and of each other. The pressure to conform in this kind of culture is significant, and is passed on through a variety of verbal and behavioral cues that reach even those patients who have broken with reality, Dr. Bennington-Davis said.

Even when they are most ill, “people with schizophrenia … respond to the environment and the culture in ways I would never have predicted but have come to see repeated over and over again,” Dr. Bennington-Davis said.

“My theory is that we are tapping into the neurolinguistic part of our brain, our humanness.

The use of physical and chemical restraints remains a thorny issue, despite great strides that are being made to improve, reduce, and eliminate the practice.

An investigative series by the Hartford Courant in 1998 prompted a federal investigation and report confirming that the use of seclusion and restraint was largely ungoverned, erratically monitored, and underreported, and had caused injury and death to both children and adults.

That same report from the U.S. General Accounting Office (now known as the Government Accountability Office) went on to say that some states had been able to reduce–and even eliminate–seclusion and restraint use. Just how clinicians are expected to accomplish that is the topic of much debate and little scientific research.

Eliminating the use of restraints in the emergency department, for example, isn't possible because, by its very nature, the ED isn't as controlled a setting as are other units, said Douglas Kupas, M.D., director of the emergency residency program at Geisinger Medical Center, Danville, Pa. Emergency departments have to consider the safety of the patient, staff, and other patients who are often in close proximity.

“Although there are deaths in patients who have been restrained, the restraint frequently has nothing to do with the cause of death. We must always work to improve our training and to use best practices when restraining patients, but many emergency medical services systems and EDs do an excellent job in restraining these very difficult patients,” he said.

Patients should be restrained in a way that maintains their dignity and permits evaluation of underlying medical conditions, he said. The staff needs both to be educated on the use of verbal de-escalation and physical and chemical restraints, and to be prepared to use the appropriate techniques.

To point to a single practice as hazardous oversimplifies the issue, Dr. Kupas said.

In particular, critics posit that restraining patients in the prone position predisposes them to suffocation. Although his practice is to avoid the prone position, Dr. Kupas said it can be helpful in the initial restraint or “take-down” of a patient.

“The key is that [restraint] is multifaceted,” he said. “There isn't a silver bullet answer, but there are many best practices that EDs should incorporate into their policies and procedures.”

Educating staff about the appropriate time to administer and remove restraints is essential, agrees David H. Dorfman, M.D., a pediatrician with the division of pediatric emergency medicine at Boston Medical Center and the department of pediatrics at Boston University.

A study led by Dr. Dorfman found that a large percentage of emergency medicine residency programs (52% of 48 respondents) and pediatric emergency medicine fellowships (82% of 33 respondents) do not teach their trainees about the application of restraints, and 35% of responding emergency medicine residencies and 64% of pediatric emergency medicine fellowships did not teach appropriate situations in which to use restraints (Pediatr. Emerg. Care 2004;20:151–6).

Chemical restraints were used in pediatric psychiatric patients in the emergency department by almost three-fourths of the respondents, but few reported having formal policies on chemical restraint.

Benzodiazepines and butyrophenones were the most commonly used agents. But both responding groups often misclassified butyrophenones as phenothiazines.

Cascading to Arrhythmia

A situation ripe for improvement is the misinterpretation of the cascade of events leading to fatal arrhythmias, particularly when patients are restrained in the prone position, said Tracy G. Sanson, M.D., assistant medical director in the department of emergency medicine at Brandon (Fla.) Regional Hospital.

In a typical scenario, a patient may be brought in by police, handcuffed to a bed after being chased for 10 blocks for selling cocaine, and administered a second intramuscular injection under restraints because nothing else is working, she said. Staff or police may increase the pressure of their hold until the patient stops resisting, at which point they assume either that the patient is “playing possum” or that the medication has taken effect.

“Essentially that is the [moment]–if you would recognize it–that if you flipped them over, defibrillated them, [and] gave them bicarb and fluids, you could get them back,” Dr. Sanson said.

The actual causes of cocaine-associated sudden death and excited delirium are unknown. But studies have suggested that the vast majority of such patients die after a struggle, which may increase the level of circulating epinephrine and may result in metabolic acidosis.

In the ED, chemical restraint should be used more aggressively, Dr. Sanson said. It must be accompanied by ongoing monitoring because of the risk of respiratory arrest and because of the cumulative effect of drugs that may have been used by the patient prior to arrival and/or those administered by ED staff.

A prospective study found that chemical restraint was added to only 28% of 298 consecutive patients restrained in an inner-city teaching hospital ED over a 1-year period (J. Emerg. Med. 2003;24:119–24). Patients were most frequently restrained on a cart with two physical restraints (59%), in the supine position (86%), with a low rate of minor complications (7%).

The federal requirement for face-to-face physician evaluation of an individual in restraints within 1 hour of the event has strengthened the focus on the safer use of seclusion and restraint. But there is no evidence that the “1-hour rule” has made restraint a safer intervention or changed practice since it was established in 1999, said Kevin Ann Huckshorn, R.N., director of the office of technical assistance for the National Association of State Mental Heath Program Directors (NASMHPD).

Promoting Prevention

NASMHPD has joined with others in calling for the application of the public health prevention model of primary, secondary, and tertiary prevention interventions to the practice of seclusion and restraint.

Primary prevention works to create an administrative and clinical treatment environment that minimizes the development of conflict.

Secondary interventions–such as comfort rooms and staff training on attitudes and behaviors in conflict settings–are focused on mitigating conflict or aggression once it occurs. Tertiary preventions address the most effective ways to mitigate damage done to patients, staff, and others who witness a seclusion and restraint event. An example is an event debriefing of all witnesses and the patient, with rigorous problem-solving activities.

Although participation by the private sector has been slow, public health care providers from all but two states have gone through NASMHPD's 21/2-day training sessions since they began in 2003. The sessions highlight six core strategies: leadership training, use of data, workforce development, prevention tools, consumer roles, and debriefing tools.

“Some states have really taken it on board,” Ms. Huckshorn said. “It's one thing to get an 'ah-ha moment,' but this was brilliant.”

The large-scale evaluation of the training will take place this year in an attempt to build an evidence-based practice, because “that is how you change clinical practice standards,” Ms. Huckshorn said.

The adoption of the Oregon model program, which also has prevention at its core, has virtually eliminated the use of seclusion and restraint in the psychiatric inpatient unit at Salem (Ore.) Hospital, said Maggie Bennington-Davis, M.D., medical director of the 24-bed, adult locked unit.

The model uses the basic tenets of the neurobiology of trauma and the development of community as set forth by author Sandra L. Bloom. The Salem team eliminated any rule that was based on staff convenience or that created a power struggle, and adopted an attitude based on patient satisfaction.

They created a social structure in which everyone is assumed to be respectful of the physical surroundings and of each other. The pressure to conform in this kind of culture is significant, and is passed on through a variety of verbal and behavioral cues that reach even those patients who have broken with reality, Dr. Bennington-Davis said.

Even when they are most ill, “people with schizophrenia … respond to the environment and the culture in ways I would never have predicted but have come to see repeated over and over again,” Dr. Bennington-Davis said.

“My theory is that we are tapping into the neurolinguistic part of our brain, our humanness.

The use of physical and chemical restraints remains a thorny issue, despite great strides that are being made to improve, reduce, and eliminate the practice.

An investigative series by the Hartford Courant in 1998 prompted a federal investigation and report confirming that the use of seclusion and restraint was largely ungoverned, erratically monitored, and underreported, and had caused injury and death to both children and adults.

That same report from the U.S. General Accounting Office (now known as the Government Accountability Office) went on to say that some states had been able to reduce–and even eliminate–seclusion and restraint use. Just how clinicians are expected to accomplish that is the topic of much debate and little scientific research.

Eliminating the use of restraints in the emergency department, for example, isn't possible because, by its very nature, the ED isn't as controlled a setting as are other units, said Douglas Kupas, M.D., director of the emergency residency program at Geisinger Medical Center, Danville, Pa. Emergency departments have to consider the safety of the patient, staff, and other patients who are often in close proximity.

“Although there are deaths in patients who have been restrained, the restraint frequently has nothing to do with the cause of death. We must always work to improve our training and to use best practices when restraining patients, but many emergency medical services systems and EDs do an excellent job in restraining these very difficult patients,” he said.

Patients should be restrained in a way that maintains their dignity and permits evaluation of underlying medical conditions, he said. The staff needs both to be educated on the use of verbal de-escalation and physical and chemical restraints, and to be prepared to use the appropriate techniques.

To point to a single practice as hazardous oversimplifies the issue, Dr. Kupas said.

In particular, critics posit that restraining patients in the prone position predisposes them to suffocation. Although his practice is to avoid the prone position, Dr. Kupas said it can be helpful in the initial restraint or “take-down” of a patient.

“The key is that [restraint] is multifaceted,” he said. “There isn't a silver bullet answer, but there are many best practices that EDs should incorporate into their policies and procedures.”

Educating staff about the appropriate time to administer and remove restraints is essential, agrees David H. Dorfman, M.D., a pediatrician with the division of pediatric emergency medicine at Boston Medical Center and the department of pediatrics at Boston University.

A study led by Dr. Dorfman found that a large percentage of emergency medicine residency programs (52% of 48 respondents) and pediatric emergency medicine fellowships (82% of 33 respondents) do not teach their trainees about the application of restraints, and 35% of responding emergency medicine residencies and 64% of pediatric emergency medicine fellowships did not teach appropriate situations in which to use restraints (Pediatr. Emerg. Care 2004;20:151–6).

Chemical restraints were used in pediatric psychiatric patients in the emergency department by almost three-fourths of the respondents, but few reported having formal policies on chemical restraint.

Benzodiazepines and butyrophenones were the most commonly used agents. But both responding groups often misclassified butyrophenones as phenothiazines.

Cascading to Arrhythmia

A situation ripe for improvement is the misinterpretation of the cascade of events leading to fatal arrhythmias, particularly when patients are restrained in the prone position, said Tracy G. Sanson, M.D., assistant medical director in the department of emergency medicine at Brandon (Fla.) Regional Hospital.

In a typical scenario, a patient may be brought in by police, handcuffed to a bed after being chased for 10 blocks for selling cocaine, and administered a second intramuscular injection under restraints because nothing else is working, she said. Staff or police may increase the pressure of their hold until the patient stops resisting, at which point they assume either that the patient is “playing possum” or that the medication has taken effect.

“Essentially that is the [moment]–if you would recognize it–that if you flipped them over, defibrillated them, [and] gave them bicarb and fluids, you could get them back,” Dr. Sanson said.

The actual causes of cocaine-associated sudden death and excited delirium are unknown. But studies have suggested that the vast majority of such patients die after a struggle, which may increase the level of circulating epinephrine and may result in metabolic acidosis.

In the ED, chemical restraint should be used more aggressively, Dr. Sanson said. It must be accompanied by ongoing monitoring because of the risk of respiratory arrest and because of the cumulative effect of drugs that may have been used by the patient prior to arrival and/or those administered by ED staff.

A prospective study found that chemical restraint was added to only 28% of 298 consecutive patients restrained in an inner-city teaching hospital ED over a 1-year period (J. Emerg. Med. 2003;24:119–24). Patients were most frequently restrained on a cart with two physical restraints (59%), in the supine position (86%), with a low rate of minor complications (7%).

The federal requirement for face-to-face physician evaluation of an individual in restraints within 1 hour of the event has strengthened the focus on the safer use of seclusion and restraint. But there is no evidence that the “1-hour rule” has made restraint a safer intervention or changed practice since it was established in 1999, said Kevin Ann Huckshorn, R.N., director of the office of technical assistance for the National Association of State Mental Heath Program Directors (NASMHPD).

Promoting Prevention

NASMHPD has joined with others in calling for the application of the public health prevention model of primary, secondary, and tertiary prevention interventions to the practice of seclusion and restraint.

Primary prevention works to create an administrative and clinical treatment environment that minimizes the development of conflict.

Secondary interventions–such as comfort rooms and staff training on attitudes and behaviors in conflict settings–are focused on mitigating conflict or aggression once it occurs. Tertiary preventions address the most effective ways to mitigate damage done to patients, staff, and others who witness a seclusion and restraint event. An example is an event debriefing of all witnesses and the patient, with rigorous problem-solving activities.

Although participation by the private sector has been slow, public health care providers from all but two states have gone through NASMHPD's 21/2-day training sessions since they began in 2003. The sessions highlight six core strategies: leadership training, use of data, workforce development, prevention tools, consumer roles, and debriefing tools.

“Some states have really taken it on board,” Ms. Huckshorn said. “It's one thing to get an 'ah-ha moment,' but this was brilliant.”

The large-scale evaluation of the training will take place this year in an attempt to build an evidence-based practice, because “that is how you change clinical practice standards,” Ms. Huckshorn said.

The adoption of the Oregon model program, which also has prevention at its core, has virtually eliminated the use of seclusion and restraint in the psychiatric inpatient unit at Salem (Ore.) Hospital, said Maggie Bennington-Davis, M.D., medical director of the 24-bed, adult locked unit.

The model uses the basic tenets of the neurobiology of trauma and the development of community as set forth by author Sandra L. Bloom. The Salem team eliminated any rule that was based on staff convenience or that created a power struggle, and adopted an attitude based on patient satisfaction.

They created a social structure in which everyone is assumed to be respectful of the physical surroundings and of each other. The pressure to conform in this kind of culture is significant, and is passed on through a variety of verbal and behavioral cues that reach even those patients who have broken with reality, Dr. Bennington-Davis said.

Even when they are most ill, “people with schizophrenia … respond to the environment and the culture in ways I would never have predicted but have come to see repeated over and over again,” Dr. Bennington-Davis said.

“My theory is that we are tapping into the neurolinguistic part of our brain, our humanness.

CHICAGO – A patient's psychological state appears more predictive than physical abnormalities of outcomes from persistent benign low back pain following herniated disk surgery, according to the conclusions of a prospective, longitudinal study.

The hypothesis from the outset was that physical findings such as disk degeneration, annular disruption, and end-plate changes would most strongly predict serious future low back pain events. However, the data did not support that theory, lead investigator Eugene J. Carragee, M.D., said at the annual meeting of the North American Spine Society.

In fact, psychosocial variables were strongly predictive of both long- and short-term disability events and health care visits for low back pain problems. Smoking and a previous workers' compensation claim also were predictive of outcomes, said Dr. Carragee of Stanford (Calif.) University.

Patients most likely to have periods of remission from their low back pain were those who were psychologically healthy, as well as those who stopped working a heavy labor job, and those who did not have chronic nonlumbar pain.

Of the physical findings, only moderate or severe Modic changes of the vertebral end plate were weakly associated with an adverse outcome.

The cohort of 100 patients had known risk factors for degenerative lumbar disk disease and a history of mild, persistent, but nondisabling, low back pain lasting more than 2 years after herniated disk surgery.

Patient selection was biased (ratio 2:1) to subjects with a history of chronic nonlumbar pain, as this group is known to be at greater risk for both increased psychosocial and neurophysiologic complications.

At baseline, 22% of patients were distressed or at risk of being distressed according to blinded psychometric testing, and 69% had other chronic pain syndromes, he said.

Physical exams and MRI studies revealed that 70% of patients had degenerated disks and 30% had annular fissures.

During the 5-year follow-up period, there were 134 back pain episodes without disability and 17 episodes with disability including four patients who went on long-term disability.

Positive findings observed in 12 of 25 patients who underwent experimental discography at baseline were not predictive of future episodes of back pain.

Instead, distress at baseline was associated with all the major adverse events. Distressed patients had more weeks of long-term disability, and suffered additional short-term work loss (0.42 episodes versus 0.015 episodes among the nondistressed patients).

Remission of 6 months or longer was reported by 26 patients, and was strongly associated with a decrease in performing heavy labor. The distressed group did not report any 6-month periods of remission, Dr. Carragee said.

Distressed patients used considerably more medical resources, compared with nondistressed patients (3.25 visits per year vs. 0.003 visits, respectively).

During the course of the study, there were 12 new workers' compensation or litigation claims made for low back conditions, half of which were filed by distressed patients early in the study, three by patients deemed at risk of being distressed, and three by patients with normal psychometric scores.

The workers' compensation claims for low back problems were strongly associated with long-term disability, severe back pain episodes, short-term disability, and medical care utilization, Dr. Carragee said at the meeting.

Current smoking status increased the likelihood of short-term disability, long-term disability, and the frequency of back pain episodes, but there was no significant association between smoking and health care visits or remission rates.

CHICAGO – A patient's psychological state appears more predictive than physical abnormalities of outcomes from persistent benign low back pain following herniated disk surgery, according to the conclusions of a prospective, longitudinal study.

The hypothesis from the outset was that physical findings such as disk degeneration, annular disruption, and end-plate changes would most strongly predict serious future low back pain events. However, the data did not support that theory, lead investigator Eugene J. Carragee, M.D., said at the annual meeting of the North American Spine Society.

In fact, psychosocial variables were strongly predictive of both long- and short-term disability events and health care visits for low back pain problems. Smoking and a previous workers' compensation claim also were predictive of outcomes, said Dr. Carragee of Stanford (Calif.) University.

Patients most likely to have periods of remission from their low back pain were those who were psychologically healthy, as well as those who stopped working a heavy labor job, and those who did not have chronic nonlumbar pain.

Of the physical findings, only moderate or severe Modic changes of the vertebral end plate were weakly associated with an adverse outcome.

The cohort of 100 patients had known risk factors for degenerative lumbar disk disease and a history of mild, persistent, but nondisabling, low back pain lasting more than 2 years after herniated disk surgery.

Patient selection was biased (ratio 2:1) to subjects with a history of chronic nonlumbar pain, as this group is known to be at greater risk for both increased psychosocial and neurophysiologic complications.

At baseline, 22% of patients were distressed or at risk of being distressed according to blinded psychometric testing, and 69% had other chronic pain syndromes, he said.

Physical exams and MRI studies revealed that 70% of patients had degenerated disks and 30% had annular fissures.

During the 5-year follow-up period, there were 134 back pain episodes without disability and 17 episodes with disability including four patients who went on long-term disability.

Positive findings observed in 12 of 25 patients who underwent experimental discography at baseline were not predictive of future episodes of back pain.

Instead, distress at baseline was associated with all the major adverse events. Distressed patients had more weeks of long-term disability, and suffered additional short-term work loss (0.42 episodes versus 0.015 episodes among the nondistressed patients).

Remission of 6 months or longer was reported by 26 patients, and was strongly associated with a decrease in performing heavy labor. The distressed group did not report any 6-month periods of remission, Dr. Carragee said.

Distressed patients used considerably more medical resources, compared with nondistressed patients (3.25 visits per year vs. 0.003 visits, respectively).

During the course of the study, there were 12 new workers' compensation or litigation claims made for low back conditions, half of which were filed by distressed patients early in the study, three by patients deemed at risk of being distressed, and three by patients with normal psychometric scores.

The workers' compensation claims for low back problems were strongly associated with long-term disability, severe back pain episodes, short-term disability, and medical care utilization, Dr. Carragee said at the meeting.

Current smoking status increased the likelihood of short-term disability, long-term disability, and the frequency of back pain episodes, but there was no significant association between smoking and health care visits or remission rates.

CHICAGO – A patient's psychological state appears more predictive than physical abnormalities of outcomes from persistent benign low back pain following herniated disk surgery, according to the conclusions of a prospective, longitudinal study.

The hypothesis from the outset was that physical findings such as disk degeneration, annular disruption, and end-plate changes would most strongly predict serious future low back pain events. However, the data did not support that theory, lead investigator Eugene J. Carragee, M.D., said at the annual meeting of the North American Spine Society.

In fact, psychosocial variables were strongly predictive of both long- and short-term disability events and health care visits for low back pain problems. Smoking and a previous workers' compensation claim also were predictive of outcomes, said Dr. Carragee of Stanford (Calif.) University.

Patients most likely to have periods of remission from their low back pain were those who were psychologically healthy, as well as those who stopped working a heavy labor job, and those who did not have chronic nonlumbar pain.

Of the physical findings, only moderate or severe Modic changes of the vertebral end plate were weakly associated with an adverse outcome.

The cohort of 100 patients had known risk factors for degenerative lumbar disk disease and a history of mild, persistent, but nondisabling, low back pain lasting more than 2 years after herniated disk surgery.

Patient selection was biased (ratio 2:1) to subjects with a history of chronic nonlumbar pain, as this group is known to be at greater risk for both increased psychosocial and neurophysiologic complications.

At baseline, 22% of patients were distressed or at risk of being distressed according to blinded psychometric testing, and 69% had other chronic pain syndromes, he said.

Physical exams and MRI studies revealed that 70% of patients had degenerated disks and 30% had annular fissures.

During the 5-year follow-up period, there were 134 back pain episodes without disability and 17 episodes with disability including four patients who went on long-term disability.

Positive findings observed in 12 of 25 patients who underwent experimental discography at baseline were not predictive of future episodes of back pain.

Instead, distress at baseline was associated with all the major adverse events. Distressed patients had more weeks of long-term disability, and suffered additional short-term work loss (0.42 episodes versus 0.015 episodes among the nondistressed patients).

Remission of 6 months or longer was reported by 26 patients, and was strongly associated with a decrease in performing heavy labor. The distressed group did not report any 6-month periods of remission, Dr. Carragee said.

Distressed patients used considerably more medical resources, compared with nondistressed patients (3.25 visits per year vs. 0.003 visits, respectively).

During the course of the study, there were 12 new workers' compensation or litigation claims made for low back conditions, half of which were filed by distressed patients early in the study, three by patients deemed at risk of being distressed, and three by patients with normal psychometric scores.

The workers' compensation claims for low back problems were strongly associated with long-term disability, severe back pain episodes, short-term disability, and medical care utilization, Dr. Carragee said at the meeting.

Current smoking status increased the likelihood of short-term disability, long-term disability, and the frequency of back pain episodes, but there was no significant association between smoking and health care visits or remission rates.

CHICAGO – A long-acting formulation of dexmethylphenidate is safe and effective in children and adolescents with attention-deficit hyperactivity disorder, according to data presented at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Children taking the investigational treatment showed improvements in core symptoms both at school and at home, compared with patients taking placebo.

The treatment, currently known as dexmethylphenidate extended-release capsules (d-MPH-ER), is a once-daily formulation of Focalin, which was introduced in 2002. D-MPH-ER is in phase III trials.

Focalin and d-MPH-ER contain only the active isomer of racemic methylphenidate (Ritalin), said lead investigator Frank Lopez, M.D., of Children's Developmental Center, Maitland, Fla.

“What's coming out well with this particular medication is that you get twice the effect at half the amount in terms of what you are delivering,” Dr. Lopez said during the poster presentation. “It's got a rapid onset, very smooth, and so far in this preliminary study, the effect was seen carrying out over 12 hours, which is a very nice thing.”

Sustained medications are often preferable to immediate-release drugs because they improve compliance and decrease the stigma of having to take medications at school.

In the double blind, parallel-group study, 103 patients (aged 6–17 years) with a previous diagnosis of ADHD of any type were randomized to receive d-MPH-ER 5–30 mg or placebo once daily for 7 weeks. A flexible dosing schedule was used during weeks 1 through 5 to determine optimal therapeutic levels, and patients were then maintained on their optimal dosages for the remaining 2 weeks.

A total of 97 patients were evaluated for efficacy, and a total of 100 patients were evaluated for safety, he said.

The primary efficacy end point for the study was change from baseline to final visit in the total subscale score of the Conners ADHD/DSM-IV Scale for Teachers (CADS-T).

At the final visit, scores on all primary and secondary efficacy end points, except the Child Health Questionnaire physical component score, were statistically superior for d-MPH-ER, compared with placebo. The differences between groups emerged early and increased over time.

The adjusted mean change from baseline to final visit in the CADS-T total score was 16.3 in the d-MPH-ER group vs. 5.7 in the placebo group.

The adjusted mean change in the CADS for Parents (CADS-P) total subscale scores from baseline was 17.6 in the d-MPH-ER group vs. 6.5 in the placebo group, he reported.

Overall, 67.3% of patients treated with d-MPH-ER were rated as “very much improved” or “much improved” on the Clinical Global Impressions-Improvement (CGI-I) scale at the final visit, compared with 13.3% of patients in the placebo group, Dr. Lopez said.

Of d-MPH-ER patients, 49% reported an adverse event, compared with 25.5% of patients in the placebo group. The most frequently reported adverse events associated with d-MPH-ER were decreased appetite (28.3%), headache (9.4%), and insomnia (7.6%). One patient in the placebo group and no one in the d-MPH-ER group discontinued use because of adverse events.

CHICAGO – A long-acting formulation of dexmethylphenidate is safe and effective in children and adolescents with attention-deficit hyperactivity disorder, according to data presented at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Children taking the investigational treatment showed improvements in core symptoms both at school and at home, compared with patients taking placebo.

The treatment, currently known as dexmethylphenidate extended-release capsules (d-MPH-ER), is a once-daily formulation of Focalin, which was introduced in 2002. D-MPH-ER is in phase III trials.

Focalin and d-MPH-ER contain only the active isomer of racemic methylphenidate (Ritalin), said lead investigator Frank Lopez, M.D., of Children's Developmental Center, Maitland, Fla.

“What's coming out well with this particular medication is that you get twice the effect at half the amount in terms of what you are delivering,” Dr. Lopez said during the poster presentation. “It's got a rapid onset, very smooth, and so far in this preliminary study, the effect was seen carrying out over 12 hours, which is a very nice thing.”

Sustained medications are often preferable to immediate-release drugs because they improve compliance and decrease the stigma of having to take medications at school.

In the double blind, parallel-group study, 103 patients (aged 6–17 years) with a previous diagnosis of ADHD of any type were randomized to receive d-MPH-ER 5–30 mg or placebo once daily for 7 weeks. A flexible dosing schedule was used during weeks 1 through 5 to determine optimal therapeutic levels, and patients were then maintained on their optimal dosages for the remaining 2 weeks.

A total of 97 patients were evaluated for efficacy, and a total of 100 patients were evaluated for safety, he said.

The primary efficacy end point for the study was change from baseline to final visit in the total subscale score of the Conners ADHD/DSM-IV Scale for Teachers (CADS-T).

At the final visit, scores on all primary and secondary efficacy end points, except the Child Health Questionnaire physical component score, were statistically superior for d-MPH-ER, compared with placebo. The differences between groups emerged early and increased over time.

The adjusted mean change from baseline to final visit in the CADS-T total score was 16.3 in the d-MPH-ER group vs. 5.7 in the placebo group.

The adjusted mean change in the CADS for Parents (CADS-P) total subscale scores from baseline was 17.6 in the d-MPH-ER group vs. 6.5 in the placebo group, he reported.

Overall, 67.3% of patients treated with d-MPH-ER were rated as “very much improved” or “much improved” on the Clinical Global Impressions-Improvement (CGI-I) scale at the final visit, compared with 13.3% of patients in the placebo group, Dr. Lopez said.

Of d-MPH-ER patients, 49% reported an adverse event, compared with 25.5% of patients in the placebo group. The most frequently reported adverse events associated with d-MPH-ER were decreased appetite (28.3%), headache (9.4%), and insomnia (7.6%). One patient in the placebo group and no one in the d-MPH-ER group discontinued use because of adverse events.

CHICAGO – A long-acting formulation of dexmethylphenidate is safe and effective in children and adolescents with attention-deficit hyperactivity disorder, according to data presented at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Children taking the investigational treatment showed improvements in core symptoms both at school and at home, compared with patients taking placebo.

The treatment, currently known as dexmethylphenidate extended-release capsules (d-MPH-ER), is a once-daily formulation of Focalin, which was introduced in 2002. D-MPH-ER is in phase III trials.

Focalin and d-MPH-ER contain only the active isomer of racemic methylphenidate (Ritalin), said lead investigator Frank Lopez, M.D., of Children's Developmental Center, Maitland, Fla.

“What's coming out well with this particular medication is that you get twice the effect at half the amount in terms of what you are delivering,” Dr. Lopez said during the poster presentation. “It's got a rapid onset, very smooth, and so far in this preliminary study, the effect was seen carrying out over 12 hours, which is a very nice thing.”

Sustained medications are often preferable to immediate-release drugs because they improve compliance and decrease the stigma of having to take medications at school.

In the double blind, parallel-group study, 103 patients (aged 6–17 years) with a previous diagnosis of ADHD of any type were randomized to receive d-MPH-ER 5–30 mg or placebo once daily for 7 weeks. A flexible dosing schedule was used during weeks 1 through 5 to determine optimal therapeutic levels, and patients were then maintained on their optimal dosages for the remaining 2 weeks.

A total of 97 patients were evaluated for efficacy, and a total of 100 patients were evaluated for safety, he said.

The primary efficacy end point for the study was change from baseline to final visit in the total subscale score of the Conners ADHD/DSM-IV Scale for Teachers (CADS-T).

At the final visit, scores on all primary and secondary efficacy end points, except the Child Health Questionnaire physical component score, were statistically superior for d-MPH-ER, compared with placebo. The differences between groups emerged early and increased over time.

The adjusted mean change from baseline to final visit in the CADS-T total score was 16.3 in the d-MPH-ER group vs. 5.7 in the placebo group.

The adjusted mean change in the CADS for Parents (CADS-P) total subscale scores from baseline was 17.6 in the d-MPH-ER group vs. 6.5 in the placebo group, he reported.

Overall, 67.3% of patients treated with d-MPH-ER were rated as “very much improved” or “much improved” on the Clinical Global Impressions-Improvement (CGI-I) scale at the final visit, compared with 13.3% of patients in the placebo group, Dr. Lopez said.

Of d-MPH-ER patients, 49% reported an adverse event, compared with 25.5% of patients in the placebo group. The most frequently reported adverse events associated with d-MPH-ER were decreased appetite (28.3%), headache (9.4%), and insomnia (7.6%). One patient in the placebo group and no one in the d-MPH-ER group discontinued use because of adverse events.