Miriam E. Tucker

WASHINGTON – One-fourth of older adults with schizophrenia shifted between remission and nonremission status in the first-ever large-scale longitudinal outcome study of older adults with schizophrenia spectrum disorder living in the community.

The 4-year longitudinal data revealed a lower persistent remission rate than had been suggested by earlier cross-sectional studies. "Our findings suggest that in addition to the increasingly recognized difficulties that older adults with schizophrenia face with respect to physical health, there is substantially more psychiatric instability than previously believed," said Dr. Carl I. Cohen, professor of psychiatry and director of the division of geriatric psychiatry at the State University of New York Downstate, Brooklyn.

Schizophrenia typically develops in the second or third decade of life, and increasing numbers of patients are surviving into old age with the disorder. Between 80% and 85% of people aged 55 years and over with schizophrenia developed it prior to age 45, with prevalence estimates for schizophrenia in adults aged between 45 and 60 of about 0.6% to 1%.

However, over the next two decades, there will be a doubling of the number of people aged 55 years and over with schizophrenia, from about 550,000 in 2005 to 1.1 million in 2025. By that time, about one-fourth of people with schizophrenia will be in this older age bracket. And in contrast to previous decades, most of these individuals are living in the community rather than in institutional settings, Dr. Cohen noted at the annual meeting of the American Association for Geriatric Psychiatry.

Recent cross-sectional studies of older adults have found remission rates of 49% (Am. J. Geriatr. Psychiatry 2008;16:966-73), 47% (J. Int. Neuropsychol. Soc. 2008;14:479-88), and 29% (Schizophr. Res. 2011;126:237-44). In longitudinal studies of remission and associated predictors in younger persons with schizophrenia, rates of clinical remission after an initial clinical episode ranged from 17% to 88% (Curr. Opin. Psychiatry 2011;24:114-21). On follow-up, the percentage of patients maintaining remission ranged from 50% to 89% (Rev. Epidemiol. Sante Publique 2009;57:25-32 and Schizophr. Res. 2009;115:58-66), with remission occurring in some of the originally nonremitted patients over time.

There have been no previous longitudinal studies in older adults, he said.

Dr. Cohen and his associates previously conducted a cross-sectional study of 198 community-dwelling adults with schizophrenia aged 55 years and over, and found that that 49% met the clinical criteria for remission, 66% met the Positive and Negative Syndrome Scale (PANSS) criteria of 3 or fewer of 8 domains, and 83% had had no hospitalizations in the past year (Am. J. Geriatr. Psychiatry 2008;16:966-73). Thus, "the study showed that symptom remission is a realistic goal for many patients," Dr. Cohen said.

In that study, four variables were associated with remission: fewer total network contacts, a greater proportion of intimates, fewer lifetime traumatic events, and higher Dementia Rating Scale scores. Type of residence, use of mental health services, and use of psychotropic medication had no significant association with remission, he said.

In the current longitudinal study, a total of 104 patients aged 55 years and older with schizophrenia spectrum disorders participated in follow-up interviews. They were followed for a mean of 52 months (range, 12-116 months). They had a mean age of 61 years, 55% were men, and 55% were white. Two-thirds (65%) lived in supported residences, while the other 35% lived independently or with family members.

To meet the criteria of remission, subjects had to score 3 or below on 8 symptom domains derived from the PANSS, and were required to have no hospitalizations during the previous year. The PANSS domains used were P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), N1 (blunted affect), N4 (passive/apathetic social withdrawal), N6 (lack of spontaneity and flow of conversation), G5 (mannerisms and posturing), and G9 (unusual thought content).

On follow-up, there were nonsignificant changes in the percentages meeting the outcomes of remission, including no hospitalizations in the past year (49% at baseline, 40% at follow-up), overall symptom remission (56% at baseline, 47% at follow-up), positive-type symptom remission (66% at baseline, 72% at follow-up), and negative-type symptom remission (64% at baseline, 68% at follow-up).

"If you look cross sectionally, you don’t see much change," Dr. Cohen noted.

However, a great deal of movement occurred between groups. Just 25% met remission criteria at both assessments, and an additional 35% did not meet remission criteria at either assessment. Another 25% went from meeting remission criteria at time 1 to not meeting remission criteria at time 2, and 16% went from not meeting remission criteria at T1 to meeting remission criteria at T2.

"Notably, half the persons in remission at time 1 were not in remission at time 2. These findings suggest that sustained remission is much less than suggested by cross-sectional studies, and optimism regarding outcome may need to be tempered.

"Secondly, [the results] suggest that symptoms in later life are not stagnant and that there is considerable flux in symptoms," he commented.

In bivariate analysis, 7 of 12 of the baseline predictor variables were significant at T1: baseline remission, total number of intimates, community integration, residential status, self-esteem score, number of psychiatric medications, and number of entitlements. Significant loss in the past 5 years at T2 also proved to be a significant predictor.

However, on logistic regression analysis, only 3 of the baseline predictors were found to predict readmission at follow-up: a higher community integration score (8.8 vs. 7.3; odds ratio, 1.52), higher number of entitlements (3.9 vs. 3.3; OR, 1.57), and a lower number of psychiatric medications (1.6 vs. 2.3; OR, 0.63). After network size at T1 was controlled for, remission at T1 was significantly correlated with network size at T2 (10.3 vs. 6.5 contacts for persons in remission at T1 vs. nonremission at T2). Baseline remission did not predict any other clinical or social variables at T2, after their baseline levels were controlled for.

"The fact that community integration can impact on subsequent clinical remission suggests that social interventions can be very important in older adults with respect to both clinical and social well-being. The significance of entitlements in this population underscores the need for older adults to secure and maintain various safety net supports as they grow older and more physically frail," Dr. Cohen said.

The finding that more psychotropic medications at baseline were associated with lower remission rates at follow-up is probably attributable to greater symptoms among the nonremission group, rather than the medications making patients worse. However, "it does suggest that the medications may not be as powerful in the older age group," he noted.

Post hoc analysis revealed that compared with the 36 patients who remained in nonremission, the 16 who improved showed higher Instrumental Activities of Daily Living scores at baseline (24.3 vs. 21.9), had a greater number of physical disorders at baseline (2.3 vs. 1.0), and had more persons in their network who could be counted on (7.3 vs. 4.6). When the investigators compared the 25 patients who remained in remission with the 25 who went from remission at baseline to nonremission at follow-up, they found that those who worsened showed lower rates of community integration scores (7.8 vs. 8.9), he said.

There were no significant changes in positive symptom remission (65% at baseline vs. 72% at follow-up), with 51% in remission at both assessments, 15% not in remission at either assessment, 14% going from remission to nonremission, and 20% from nonremission to remission. There were also no significant changes in negative symptom remission (64% at baseline vs. 68% at follow-up), with 54% in remission at both assessments, 23% not in remission at either assessment, 10% going from remission to nonremission, and 14% from nonremission to remission.

"Little is known about the factors that predict the movement from remission to nonremission status and vice versa. Our preliminary data – with a fairly small subsample – suggest that social and functional factors are important," Dr. Cohen concluded. "More studies are needed to identify those factors that move persons toward remission."

Dr. Cohen’s research was funded in part by a grant from the National Institute of General Medical Sciences. He reported no other disclosures.

WASHINGTON – One-fourth of older adults with schizophrenia shifted between remission and nonremission status in the first-ever large-scale longitudinal outcome study of older adults with schizophrenia spectrum disorder living in the community.

The 4-year longitudinal data revealed a lower persistent remission rate than had been suggested by earlier cross-sectional studies. "Our findings suggest that in addition to the increasingly recognized difficulties that older adults with schizophrenia face with respect to physical health, there is substantially more psychiatric instability than previously believed," said Dr. Carl I. Cohen, professor of psychiatry and director of the division of geriatric psychiatry at the State University of New York Downstate, Brooklyn.

Schizophrenia typically develops in the second or third decade of life, and increasing numbers of patients are surviving into old age with the disorder. Between 80% and 85% of people aged 55 years and over with schizophrenia developed it prior to age 45, with prevalence estimates for schizophrenia in adults aged between 45 and 60 of about 0.6% to 1%.

However, over the next two decades, there will be a doubling of the number of people aged 55 years and over with schizophrenia, from about 550,000 in 2005 to 1.1 million in 2025. By that time, about one-fourth of people with schizophrenia will be in this older age bracket. And in contrast to previous decades, most of these individuals are living in the community rather than in institutional settings, Dr. Cohen noted at the annual meeting of the American Association for Geriatric Psychiatry.

Recent cross-sectional studies of older adults have found remission rates of 49% (Am. J. Geriatr. Psychiatry 2008;16:966-73), 47% (J. Int. Neuropsychol. Soc. 2008;14:479-88), and 29% (Schizophr. Res. 2011;126:237-44). In longitudinal studies of remission and associated predictors in younger persons with schizophrenia, rates of clinical remission after an initial clinical episode ranged from 17% to 88% (Curr. Opin. Psychiatry 2011;24:114-21). On follow-up, the percentage of patients maintaining remission ranged from 50% to 89% (Rev. Epidemiol. Sante Publique 2009;57:25-32 and Schizophr. Res. 2009;115:58-66), with remission occurring in some of the originally nonremitted patients over time.

There have been no previous longitudinal studies in older adults, he said.

Dr. Cohen and his associates previously conducted a cross-sectional study of 198 community-dwelling adults with schizophrenia aged 55 years and over, and found that that 49% met the clinical criteria for remission, 66% met the Positive and Negative Syndrome Scale (PANSS) criteria of 3 or fewer of 8 domains, and 83% had had no hospitalizations in the past year (Am. J. Geriatr. Psychiatry 2008;16:966-73). Thus, "the study showed that symptom remission is a realistic goal for many patients," Dr. Cohen said.

In that study, four variables were associated with remission: fewer total network contacts, a greater proportion of intimates, fewer lifetime traumatic events, and higher Dementia Rating Scale scores. Type of residence, use of mental health services, and use of psychotropic medication had no significant association with remission, he said.

In the current longitudinal study, a total of 104 patients aged 55 years and older with schizophrenia spectrum disorders participated in follow-up interviews. They were followed for a mean of 52 months (range, 12-116 months). They had a mean age of 61 years, 55% were men, and 55% were white. Two-thirds (65%) lived in supported residences, while the other 35% lived independently or with family members.

To meet the criteria of remission, subjects had to score 3 or below on 8 symptom domains derived from the PANSS, and were required to have no hospitalizations during the previous year. The PANSS domains used were P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), N1 (blunted affect), N4 (passive/apathetic social withdrawal), N6 (lack of spontaneity and flow of conversation), G5 (mannerisms and posturing), and G9 (unusual thought content).

On follow-up, there were nonsignificant changes in the percentages meeting the outcomes of remission, including no hospitalizations in the past year (49% at baseline, 40% at follow-up), overall symptom remission (56% at baseline, 47% at follow-up), positive-type symptom remission (66% at baseline, 72% at follow-up), and negative-type symptom remission (64% at baseline, 68% at follow-up).

"If you look cross sectionally, you don’t see much change," Dr. Cohen noted.

However, a great deal of movement occurred between groups. Just 25% met remission criteria at both assessments, and an additional 35% did not meet remission criteria at either assessment. Another 25% went from meeting remission criteria at time 1 to not meeting remission criteria at time 2, and 16% went from not meeting remission criteria at T1 to meeting remission criteria at T2.

"Notably, half the persons in remission at time 1 were not in remission at time 2. These findings suggest that sustained remission is much less than suggested by cross-sectional studies, and optimism regarding outcome may need to be tempered.

"Secondly, [the results] suggest that symptoms in later life are not stagnant and that there is considerable flux in symptoms," he commented.

In bivariate analysis, 7 of 12 of the baseline predictor variables were significant at T1: baseline remission, total number of intimates, community integration, residential status, self-esteem score, number of psychiatric medications, and number of entitlements. Significant loss in the past 5 years at T2 also proved to be a significant predictor.

However, on logistic regression analysis, only 3 of the baseline predictors were found to predict readmission at follow-up: a higher community integration score (8.8 vs. 7.3; odds ratio, 1.52), higher number of entitlements (3.9 vs. 3.3; OR, 1.57), and a lower number of psychiatric medications (1.6 vs. 2.3; OR, 0.63). After network size at T1 was controlled for, remission at T1 was significantly correlated with network size at T2 (10.3 vs. 6.5 contacts for persons in remission at T1 vs. nonremission at T2). Baseline remission did not predict any other clinical or social variables at T2, after their baseline levels were controlled for.

"The fact that community integration can impact on subsequent clinical remission suggests that social interventions can be very important in older adults with respect to both clinical and social well-being. The significance of entitlements in this population underscores the need for older adults to secure and maintain various safety net supports as they grow older and more physically frail," Dr. Cohen said.

The finding that more psychotropic medications at baseline were associated with lower remission rates at follow-up is probably attributable to greater symptoms among the nonremission group, rather than the medications making patients worse. However, "it does suggest that the medications may not be as powerful in the older age group," he noted.

Post hoc analysis revealed that compared with the 36 patients who remained in nonremission, the 16 who improved showed higher Instrumental Activities of Daily Living scores at baseline (24.3 vs. 21.9), had a greater number of physical disorders at baseline (2.3 vs. 1.0), and had more persons in their network who could be counted on (7.3 vs. 4.6). When the investigators compared the 25 patients who remained in remission with the 25 who went from remission at baseline to nonremission at follow-up, they found that those who worsened showed lower rates of community integration scores (7.8 vs. 8.9), he said.

There were no significant changes in positive symptom remission (65% at baseline vs. 72% at follow-up), with 51% in remission at both assessments, 15% not in remission at either assessment, 14% going from remission to nonremission, and 20% from nonremission to remission. There were also no significant changes in negative symptom remission (64% at baseline vs. 68% at follow-up), with 54% in remission at both assessments, 23% not in remission at either assessment, 10% going from remission to nonremission, and 14% from nonremission to remission.

"Little is known about the factors that predict the movement from remission to nonremission status and vice versa. Our preliminary data – with a fairly small subsample – suggest that social and functional factors are important," Dr. Cohen concluded. "More studies are needed to identify those factors that move persons toward remission."

Dr. Cohen’s research was funded in part by a grant from the National Institute of General Medical Sciences. He reported no other disclosures.

WASHINGTON – One-fourth of older adults with schizophrenia shifted between remission and nonremission status in the first-ever large-scale longitudinal outcome study of older adults with schizophrenia spectrum disorder living in the community.

The 4-year longitudinal data revealed a lower persistent remission rate than had been suggested by earlier cross-sectional studies. "Our findings suggest that in addition to the increasingly recognized difficulties that older adults with schizophrenia face with respect to physical health, there is substantially more psychiatric instability than previously believed," said Dr. Carl I. Cohen, professor of psychiatry and director of the division of geriatric psychiatry at the State University of New York Downstate, Brooklyn.

Schizophrenia typically develops in the second or third decade of life, and increasing numbers of patients are surviving into old age with the disorder. Between 80% and 85% of people aged 55 years and over with schizophrenia developed it prior to age 45, with prevalence estimates for schizophrenia in adults aged between 45 and 60 of about 0.6% to 1%.

However, over the next two decades, there will be a doubling of the number of people aged 55 years and over with schizophrenia, from about 550,000 in 2005 to 1.1 million in 2025. By that time, about one-fourth of people with schizophrenia will be in this older age bracket. And in contrast to previous decades, most of these individuals are living in the community rather than in institutional settings, Dr. Cohen noted at the annual meeting of the American Association for Geriatric Psychiatry.

Recent cross-sectional studies of older adults have found remission rates of 49% (Am. J. Geriatr. Psychiatry 2008;16:966-73), 47% (J. Int. Neuropsychol. Soc. 2008;14:479-88), and 29% (Schizophr. Res. 2011;126:237-44). In longitudinal studies of remission and associated predictors in younger persons with schizophrenia, rates of clinical remission after an initial clinical episode ranged from 17% to 88% (Curr. Opin. Psychiatry 2011;24:114-21). On follow-up, the percentage of patients maintaining remission ranged from 50% to 89% (Rev. Epidemiol. Sante Publique 2009;57:25-32 and Schizophr. Res. 2009;115:58-66), with remission occurring in some of the originally nonremitted patients over time.

There have been no previous longitudinal studies in older adults, he said.

Dr. Cohen and his associates previously conducted a cross-sectional study of 198 community-dwelling adults with schizophrenia aged 55 years and over, and found that that 49% met the clinical criteria for remission, 66% met the Positive and Negative Syndrome Scale (PANSS) criteria of 3 or fewer of 8 domains, and 83% had had no hospitalizations in the past year (Am. J. Geriatr. Psychiatry 2008;16:966-73). Thus, "the study showed that symptom remission is a realistic goal for many patients," Dr. Cohen said.

In that study, four variables were associated with remission: fewer total network contacts, a greater proportion of intimates, fewer lifetime traumatic events, and higher Dementia Rating Scale scores. Type of residence, use of mental health services, and use of psychotropic medication had no significant association with remission, he said.

In the current longitudinal study, a total of 104 patients aged 55 years and older with schizophrenia spectrum disorders participated in follow-up interviews. They were followed for a mean of 52 months (range, 12-116 months). They had a mean age of 61 years, 55% were men, and 55% were white. Two-thirds (65%) lived in supported residences, while the other 35% lived independently or with family members.

To meet the criteria of remission, subjects had to score 3 or below on 8 symptom domains derived from the PANSS, and were required to have no hospitalizations during the previous year. The PANSS domains used were P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), N1 (blunted affect), N4 (passive/apathetic social withdrawal), N6 (lack of spontaneity and flow of conversation), G5 (mannerisms and posturing), and G9 (unusual thought content).

On follow-up, there were nonsignificant changes in the percentages meeting the outcomes of remission, including no hospitalizations in the past year (49% at baseline, 40% at follow-up), overall symptom remission (56% at baseline, 47% at follow-up), positive-type symptom remission (66% at baseline, 72% at follow-up), and negative-type symptom remission (64% at baseline, 68% at follow-up).

"If you look cross sectionally, you don’t see much change," Dr. Cohen noted.

However, a great deal of movement occurred between groups. Just 25% met remission criteria at both assessments, and an additional 35% did not meet remission criteria at either assessment. Another 25% went from meeting remission criteria at time 1 to not meeting remission criteria at time 2, and 16% went from not meeting remission criteria at T1 to meeting remission criteria at T2.

"Notably, half the persons in remission at time 1 were not in remission at time 2. These findings suggest that sustained remission is much less than suggested by cross-sectional studies, and optimism regarding outcome may need to be tempered.

"Secondly, [the results] suggest that symptoms in later life are not stagnant and that there is considerable flux in symptoms," he commented.

In bivariate analysis, 7 of 12 of the baseline predictor variables were significant at T1: baseline remission, total number of intimates, community integration, residential status, self-esteem score, number of psychiatric medications, and number of entitlements. Significant loss in the past 5 years at T2 also proved to be a significant predictor.

However, on logistic regression analysis, only 3 of the baseline predictors were found to predict readmission at follow-up: a higher community integration score (8.8 vs. 7.3; odds ratio, 1.52), higher number of entitlements (3.9 vs. 3.3; OR, 1.57), and a lower number of psychiatric medications (1.6 vs. 2.3; OR, 0.63). After network size at T1 was controlled for, remission at T1 was significantly correlated with network size at T2 (10.3 vs. 6.5 contacts for persons in remission at T1 vs. nonremission at T2). Baseline remission did not predict any other clinical or social variables at T2, after their baseline levels were controlled for.

"The fact that community integration can impact on subsequent clinical remission suggests that social interventions can be very important in older adults with respect to both clinical and social well-being. The significance of entitlements in this population underscores the need for older adults to secure and maintain various safety net supports as they grow older and more physically frail," Dr. Cohen said.

The finding that more psychotropic medications at baseline were associated with lower remission rates at follow-up is probably attributable to greater symptoms among the nonremission group, rather than the medications making patients worse. However, "it does suggest that the medications may not be as powerful in the older age group," he noted.

Post hoc analysis revealed that compared with the 36 patients who remained in nonremission, the 16 who improved showed higher Instrumental Activities of Daily Living scores at baseline (24.3 vs. 21.9), had a greater number of physical disorders at baseline (2.3 vs. 1.0), and had more persons in their network who could be counted on (7.3 vs. 4.6). When the investigators compared the 25 patients who remained in remission with the 25 who went from remission at baseline to nonremission at follow-up, they found that those who worsened showed lower rates of community integration scores (7.8 vs. 8.9), he said.

There were no significant changes in positive symptom remission (65% at baseline vs. 72% at follow-up), with 51% in remission at both assessments, 15% not in remission at either assessment, 14% going from remission to nonremission, and 20% from nonremission to remission. There were also no significant changes in negative symptom remission (64% at baseline vs. 68% at follow-up), with 54% in remission at both assessments, 23% not in remission at either assessment, 10% going from remission to nonremission, and 14% from nonremission to remission.

"Little is known about the factors that predict the movement from remission to nonremission status and vice versa. Our preliminary data – with a fairly small subsample – suggest that social and functional factors are important," Dr. Cohen concluded. "More studies are needed to identify those factors that move persons toward remission."

Dr. Cohen’s research was funded in part by a grant from the National Institute of General Medical Sciences. He reported no other disclosures.

Infrared thermography did not accurately predict malignancy and produced an unacceptably high false-positive rate in women with radiologic abnormalities requiring breast biopsy in a 2-year prospective study.

The No-Touch Breast Scan (NTBS) is a noninvasive, non–radiation-based imaging tool that measures and compares thermal abnormalities in breasts using dual infrared cameras and computer analysis. It generates a score that reflects blood flow patterns based on the theory of tumor angiogenesis.

The technology is being explored as an alternative to radiation-based imaging in women at risk for breast cancer and as a way to reduce the number of benign biopsies, Dr. Andrea V. Barrio said during a press briefing at the annual meeting of the American Society of Breast Surgeons.

This study evaluated NTBS screening as a predictor of breast cancer in patients undergoing minimally invasive breast biopsy for suspicious mammogram, ultrasound, or MRI findings.

But the results demonstrated that NTBS "cannot be used as a successful adjunct to mammography, nor can it replace any of the screening modalities that are standard practice. Mammography remains the gold standard for breast cancer screening," said Dr. Barrio, an attending breast surgeon at Bryn Mawr (Pa.) Hospital.

"I think the utility of NTBS remains unclear. For the purposes of our study, NTBS could not discriminate between benign and malignant lesions in the low-specificity mode, and the high-sensitivity mode resulted in an unacceptable number of false-positive results," she added in an interview.

A total of 181 women (median age at diagnosis 52.5 years) with 187 abnormal radiologic findings were evaluated from October 2009 to May 2011. Each patient had an NTBS prior to tissue biopsy, and final tissue pathologies were compared with the corresponding NTBS scan results. Each breast was interpreted as positive or negative based on computer analysis of thermal abnormalities. The contralateral breast was scanned in all patients.

Prior to Oct. 15, 2010, patients were initially scanned using a "high-specificity" NTBS mode termed NTBS1. Subsequently a "high-sensitivity mode (NTBS2)" was used to minimize false-negative results. Following initial data analysis, all patients were retrospectively re-evaluated in the NTBS2 mode.

Of the 181 patients initially evaluated, 3 were excluded due to a nonductal or lobular breast malignancy, leaving a total of 178 patients. Of those, 50 had 52 positive breast biopsies and 128 had 132 negative biopsies.

Of the 52 positive biopsies, only 26 had a positive NTBS, giving a sensitivity of just 50%. The sensitivity of NTBS was even lower in the 20 in situ cancers, compared with the 32 invasive cancers (35% vs. 59%, respectively), Dr. Barrio reported.

Of the 132 negative biopsies, 88 had negative NTBS scans, giving a 67% specificity. "The positive predictive value of NTBS was 37% and the negative predictive value was 77%," the study results showed.

Of 173 normal contralateral breasts that were scanned, 42 (24%) had a positive NTBS scan.

Among the 178 patients retrospectively evaluated using NTBS2, 22 were excluded because of an uninterpretable scan. Of the remaining 156 patients, 44 had 46 positive breast biopsies and 112 had 116 negative biopsies. Forty of the 46 positive biopsies matched a positive NTBS (sensitivity 87%).

Sensitivity was not appreciably different between in situ and invasive cancers in the NTBS2 mode (88% vs. 86%, respectively), she said.

Of the 116 negative biopsies, 55 had a negative NTBS, giving a specificity of just 48%. "The positive predictive value of NTBS2 was 40% and the negative predictive value was 90%," the study reported. Of the 151 normal contralateral breasts that were scanned, 72 (47%) had a positive reading.

In the interview, Dr. Barrio said that her group is not seeking a replacement for mammography, as it is a cost-efficient screening tool that has been proven to decrease mortality from breast cancer.

However, "we are looking for studies to supplement mammography, in order to address its limitations, i.e., dense breasts. I think molecular breast imaging in particular shows a lot of promise for the future in women with dense breasts."

This study was funded by the Humler Oncology fund. Dr. Barrio had no other disclosures.

Infrared thermography did not accurately predict malignancy and produced an unacceptably high false-positive rate in women with radiologic abnormalities requiring breast biopsy in a 2-year prospective study.

The No-Touch Breast Scan (NTBS) is a noninvasive, non–radiation-based imaging tool that measures and compares thermal abnormalities in breasts using dual infrared cameras and computer analysis. It generates a score that reflects blood flow patterns based on the theory of tumor angiogenesis.

The technology is being explored as an alternative to radiation-based imaging in women at risk for breast cancer and as a way to reduce the number of benign biopsies, Dr. Andrea V. Barrio said during a press briefing at the annual meeting of the American Society of Breast Surgeons.

This study evaluated NTBS screening as a predictor of breast cancer in patients undergoing minimally invasive breast biopsy for suspicious mammogram, ultrasound, or MRI findings.

But the results demonstrated that NTBS "cannot be used as a successful adjunct to mammography, nor can it replace any of the screening modalities that are standard practice. Mammography remains the gold standard for breast cancer screening," said Dr. Barrio, an attending breast surgeon at Bryn Mawr (Pa.) Hospital.

"I think the utility of NTBS remains unclear. For the purposes of our study, NTBS could not discriminate between benign and malignant lesions in the low-specificity mode, and the high-sensitivity mode resulted in an unacceptable number of false-positive results," she added in an interview.

A total of 181 women (median age at diagnosis 52.5 years) with 187 abnormal radiologic findings were evaluated from October 2009 to May 2011. Each patient had an NTBS prior to tissue biopsy, and final tissue pathologies were compared with the corresponding NTBS scan results. Each breast was interpreted as positive or negative based on computer analysis of thermal abnormalities. The contralateral breast was scanned in all patients.

Prior to Oct. 15, 2010, patients were initially scanned using a "high-specificity" NTBS mode termed NTBS1. Subsequently a "high-sensitivity mode (NTBS2)" was used to minimize false-negative results. Following initial data analysis, all patients were retrospectively re-evaluated in the NTBS2 mode.

Of the 181 patients initially evaluated, 3 were excluded due to a nonductal or lobular breast malignancy, leaving a total of 178 patients. Of those, 50 had 52 positive breast biopsies and 128 had 132 negative biopsies.

Of the 52 positive biopsies, only 26 had a positive NTBS, giving a sensitivity of just 50%. The sensitivity of NTBS was even lower in the 20 in situ cancers, compared with the 32 invasive cancers (35% vs. 59%, respectively), Dr. Barrio reported.

Of the 132 negative biopsies, 88 had negative NTBS scans, giving a 67% specificity. "The positive predictive value of NTBS was 37% and the negative predictive value was 77%," the study results showed.

Of 173 normal contralateral breasts that were scanned, 42 (24%) had a positive NTBS scan.

Among the 178 patients retrospectively evaluated using NTBS2, 22 were excluded because of an uninterpretable scan. Of the remaining 156 patients, 44 had 46 positive breast biopsies and 112 had 116 negative biopsies. Forty of the 46 positive biopsies matched a positive NTBS (sensitivity 87%).

Sensitivity was not appreciably different between in situ and invasive cancers in the NTBS2 mode (88% vs. 86%, respectively), she said.

Of the 116 negative biopsies, 55 had a negative NTBS, giving a specificity of just 48%. "The positive predictive value of NTBS2 was 40% and the negative predictive value was 90%," the study reported. Of the 151 normal contralateral breasts that were scanned, 72 (47%) had a positive reading.

In the interview, Dr. Barrio said that her group is not seeking a replacement for mammography, as it is a cost-efficient screening tool that has been proven to decrease mortality from breast cancer.

However, "we are looking for studies to supplement mammography, in order to address its limitations, i.e., dense breasts. I think molecular breast imaging in particular shows a lot of promise for the future in women with dense breasts."

This study was funded by the Humler Oncology fund. Dr. Barrio had no other disclosures.

Infrared thermography did not accurately predict malignancy and produced an unacceptably high false-positive rate in women with radiologic abnormalities requiring breast biopsy in a 2-year prospective study.

The No-Touch Breast Scan (NTBS) is a noninvasive, non–radiation-based imaging tool that measures and compares thermal abnormalities in breasts using dual infrared cameras and computer analysis. It generates a score that reflects blood flow patterns based on the theory of tumor angiogenesis.

The technology is being explored as an alternative to radiation-based imaging in women at risk for breast cancer and as a way to reduce the number of benign biopsies, Dr. Andrea V. Barrio said during a press briefing at the annual meeting of the American Society of Breast Surgeons.

This study evaluated NTBS screening as a predictor of breast cancer in patients undergoing minimally invasive breast biopsy for suspicious mammogram, ultrasound, or MRI findings.

But the results demonstrated that NTBS "cannot be used as a successful adjunct to mammography, nor can it replace any of the screening modalities that are standard practice. Mammography remains the gold standard for breast cancer screening," said Dr. Barrio, an attending breast surgeon at Bryn Mawr (Pa.) Hospital.

"I think the utility of NTBS remains unclear. For the purposes of our study, NTBS could not discriminate between benign and malignant lesions in the low-specificity mode, and the high-sensitivity mode resulted in an unacceptable number of false-positive results," she added in an interview.

A total of 181 women (median age at diagnosis 52.5 years) with 187 abnormal radiologic findings were evaluated from October 2009 to May 2011. Each patient had an NTBS prior to tissue biopsy, and final tissue pathologies were compared with the corresponding NTBS scan results. Each breast was interpreted as positive or negative based on computer analysis of thermal abnormalities. The contralateral breast was scanned in all patients.

Prior to Oct. 15, 2010, patients were initially scanned using a "high-specificity" NTBS mode termed NTBS1. Subsequently a "high-sensitivity mode (NTBS2)" was used to minimize false-negative results. Following initial data analysis, all patients were retrospectively re-evaluated in the NTBS2 mode.

Of the 181 patients initially evaluated, 3 were excluded due to a nonductal or lobular breast malignancy, leaving a total of 178 patients. Of those, 50 had 52 positive breast biopsies and 128 had 132 negative biopsies.

Of the 52 positive biopsies, only 26 had a positive NTBS, giving a sensitivity of just 50%. The sensitivity of NTBS was even lower in the 20 in situ cancers, compared with the 32 invasive cancers (35% vs. 59%, respectively), Dr. Barrio reported.

Of the 132 negative biopsies, 88 had negative NTBS scans, giving a 67% specificity. "The positive predictive value of NTBS was 37% and the negative predictive value was 77%," the study results showed.

Of 173 normal contralateral breasts that were scanned, 42 (24%) had a positive NTBS scan.

Among the 178 patients retrospectively evaluated using NTBS2, 22 were excluded because of an uninterpretable scan. Of the remaining 156 patients, 44 had 46 positive breast biopsies and 112 had 116 negative biopsies. Forty of the 46 positive biopsies matched a positive NTBS (sensitivity 87%).

Sensitivity was not appreciably different between in situ and invasive cancers in the NTBS2 mode (88% vs. 86%, respectively), she said.

Of the 116 negative biopsies, 55 had a negative NTBS, giving a specificity of just 48%. "The positive predictive value of NTBS2 was 40% and the negative predictive value was 90%," the study reported. Of the 151 normal contralateral breasts that were scanned, 72 (47%) had a positive reading.

In the interview, Dr. Barrio said that her group is not seeking a replacement for mammography, as it is a cost-efficient screening tool that has been proven to decrease mortality from breast cancer.

However, "we are looking for studies to supplement mammography, in order to address its limitations, i.e., dense breasts. I think molecular breast imaging in particular shows a lot of promise for the future in women with dense breasts."

This study was funded by the Humler Oncology fund. Dr. Barrio had no other disclosures.

Men with breast cancer died more than 2 years sooner than did women with the condition, in the largest-ever study of male breast cancer, investigators reported.

Male breast cancer patients presented with more advanced disease and had lower 5-year survival rates as well as shorter median overall survival than did women, Dr. Jon M. Greif said at the annual meeting of the American Society of Breast Surgeons.

They were less likely to have radiation therapy or partial mastectomy, but chemotherapy rates were not significantly different, said Dr. Greif, a breast surgeon who practices in Oakland, Calif.

The data come from an analysis of 13,457 men – representing 0.9% of all breast cancers – and 1,439,866 women with breast cancer in the National Cancer Data Base spanning the years 1998 through 2007. The explanation for the differences in overall survival is most likely multifactorial, according to Dr. Greif.

"Certainly, one reason is that with well accepted screening for female breast cancer, and heightened awareness amongst women, female breast cancer is detected earlier. Evidence from our study is that male breast cancer is larger and more likely to have spread to lymph nodes and beyond when first discovered," he said in an interview.

"However, male breast cancer was less likely to be low grade, and this would be a biological difference. And, finally, men were older, and more likely to die of other causes."

Men at particularly high risk should have careful clinical examinations annually, and consider annual screening mammography, advised Dr. Greif. Among those at high risk, he included men with known gene mutations that increase their risk (BRCA and Klinefelter’s syndrome, for example), men who have been treated or otherwise exposed to high levels of radiation to the chest, men with previous breast cancer, and men with strong family histories of male or female breast cancer.

"Currently, breast cancer in men is found as a palpable retro- or periareolar mass, a nipple discharge or crusting, skin erosion, or palpable lymph nodes. Examination of the retroareolar and periareolar tissues for lumps and/or skin changes should be a part of every man’s annual physical exam, and men should check occasionally themselves," Dr. Greif said.

Five-year overall survival was 83% for women with breast cancer (median survival 129 months) and 74% for men (median 101 months), a highly statistically significant difference (P less than. 0001), he reported.

A comparison of overall survival by stages showed significantly better outcomes for women with early disease, but similar outcomes in more advanced disease. Females had significantly better 5-year survival rates (P less than .0001) for stage 0 (94% vs. 90%), stage I (90% vs. 87%) and stage II (82% vs. 74%) breast cancer. No significant differences were seen in 5-year survival for stage III (56.9% vs. 56.5%, P = .99) or stage IV (19% vs. 16%, P = .20).

The following findings also were reported:

– Men with breast cancer were more often African American (11.7% vs. 9.9%, odds ratio 1.19), less often Hispanic (3.6% vs. 4.5%, OR 0.74), and older (63 vs. 59 years old).

– Men had larger tumors (median 20.0 vs. 15.0 mm), were less likely to have grade 1 tumors (16.0% vs. 20.7%), were more likely to have lymph node metastasis (41.9% vs. 33.2%, OR 1.45), and were more likely to have distant metastasis (4% vs. 3%, OR 1.39).

– Men were less likely to have lobular carcinoma (10% vs. 18%, OR 0.51) and more likely to be estrogen receptor positive (88.3% vs. 78.2%, OR 2.10) and progesterone receptor positive (76.8% vs. 67.0%, OR 1.63).

– Men were less likely to have been treated with a partial mastectomy (33% vs. 62%, OR 0.31) and less likely to have received radiation (35.9% vs. 50.4%, OR 0.55).

All of these differences were highly statistically significant, with P values less than .0001. However, the differences may not have been of clinical significance, the investigators said, citing the large numbers of cases.

The proportions of men and women receiving chemotherapy were similar (40.1% vs. 39.8%, OR 1.01, P = .40) and only small differences were seen in hormonal therapy rates (41.2% vs. 42.4%, OR 0.95, P = .006).

Treatment of male breast cancer is similar to that of female breast cancer, according to Dr. Greif. Nearly all male breast cancers are hormone receptor positive, so treatment with antiestrogenic endocrine therapy should be a part of the adjuvant treatment of nearly all male breast cancer.

Chemotherapy should be considered for tumors with higher risk of systemic return, he said. For tumors with risk of locoregional return, including those that are large and/or have lymph node involvement, adjuvant radiation should be part of the treatment.

The surgery for male breast cancer is almost always total mastectomy, he noted, and there is evidence that sentinel lymph node biopsy works for male breast cancer as well as in female breast cancer.

This study was funded in part by Alta Bates Summit Medical Center. None of the authors have any conflicts of interest or financial disclosures.

Men with breast cancer died more than 2 years sooner than did women with the condition, in the largest-ever study of male breast cancer, investigators reported.

Male breast cancer patients presented with more advanced disease and had lower 5-year survival rates as well as shorter median overall survival than did women, Dr. Jon M. Greif said at the annual meeting of the American Society of Breast Surgeons.

They were less likely to have radiation therapy or partial mastectomy, but chemotherapy rates were not significantly different, said Dr. Greif, a breast surgeon who practices in Oakland, Calif.

The data come from an analysis of 13,457 men – representing 0.9% of all breast cancers – and 1,439,866 women with breast cancer in the National Cancer Data Base spanning the years 1998 through 2007. The explanation for the differences in overall survival is most likely multifactorial, according to Dr. Greif.

"Certainly, one reason is that with well accepted screening for female breast cancer, and heightened awareness amongst women, female breast cancer is detected earlier. Evidence from our study is that male breast cancer is larger and more likely to have spread to lymph nodes and beyond when first discovered," he said in an interview.

"However, male breast cancer was less likely to be low grade, and this would be a biological difference. And, finally, men were older, and more likely to die of other causes."

Men at particularly high risk should have careful clinical examinations annually, and consider annual screening mammography, advised Dr. Greif. Among those at high risk, he included men with known gene mutations that increase their risk (BRCA and Klinefelter’s syndrome, for example), men who have been treated or otherwise exposed to high levels of radiation to the chest, men with previous breast cancer, and men with strong family histories of male or female breast cancer.

"Currently, breast cancer in men is found as a palpable retro- or periareolar mass, a nipple discharge or crusting, skin erosion, or palpable lymph nodes. Examination of the retroareolar and periareolar tissues for lumps and/or skin changes should be a part of every man’s annual physical exam, and men should check occasionally themselves," Dr. Greif said.

Five-year overall survival was 83% for women with breast cancer (median survival 129 months) and 74% for men (median 101 months), a highly statistically significant difference (P less than. 0001), he reported.

A comparison of overall survival by stages showed significantly better outcomes for women with early disease, but similar outcomes in more advanced disease. Females had significantly better 5-year survival rates (P less than .0001) for stage 0 (94% vs. 90%), stage I (90% vs. 87%) and stage II (82% vs. 74%) breast cancer. No significant differences were seen in 5-year survival for stage III (56.9% vs. 56.5%, P = .99) or stage IV (19% vs. 16%, P = .20).

The following findings also were reported:

– Men with breast cancer were more often African American (11.7% vs. 9.9%, odds ratio 1.19), less often Hispanic (3.6% vs. 4.5%, OR 0.74), and older (63 vs. 59 years old).

– Men had larger tumors (median 20.0 vs. 15.0 mm), were less likely to have grade 1 tumors (16.0% vs. 20.7%), were more likely to have lymph node metastasis (41.9% vs. 33.2%, OR 1.45), and were more likely to have distant metastasis (4% vs. 3%, OR 1.39).

– Men were less likely to have lobular carcinoma (10% vs. 18%, OR 0.51) and more likely to be estrogen receptor positive (88.3% vs. 78.2%, OR 2.10) and progesterone receptor positive (76.8% vs. 67.0%, OR 1.63).

– Men were less likely to have been treated with a partial mastectomy (33% vs. 62%, OR 0.31) and less likely to have received radiation (35.9% vs. 50.4%, OR 0.55).

All of these differences were highly statistically significant, with P values less than .0001. However, the differences may not have been of clinical significance, the investigators said, citing the large numbers of cases.

The proportions of men and women receiving chemotherapy were similar (40.1% vs. 39.8%, OR 1.01, P = .40) and only small differences were seen in hormonal therapy rates (41.2% vs. 42.4%, OR 0.95, P = .006).

Treatment of male breast cancer is similar to that of female breast cancer, according to Dr. Greif. Nearly all male breast cancers are hormone receptor positive, so treatment with antiestrogenic endocrine therapy should be a part of the adjuvant treatment of nearly all male breast cancer.

Chemotherapy should be considered for tumors with higher risk of systemic return, he said. For tumors with risk of locoregional return, including those that are large and/or have lymph node involvement, adjuvant radiation should be part of the treatment.

The surgery for male breast cancer is almost always total mastectomy, he noted, and there is evidence that sentinel lymph node biopsy works for male breast cancer as well as in female breast cancer.

This study was funded in part by Alta Bates Summit Medical Center. None of the authors have any conflicts of interest or financial disclosures.

Men with breast cancer died more than 2 years sooner than did women with the condition, in the largest-ever study of male breast cancer, investigators reported.

Male breast cancer patients presented with more advanced disease and had lower 5-year survival rates as well as shorter median overall survival than did women, Dr. Jon M. Greif said at the annual meeting of the American Society of Breast Surgeons.

They were less likely to have radiation therapy or partial mastectomy, but chemotherapy rates were not significantly different, said Dr. Greif, a breast surgeon who practices in Oakland, Calif.

The data come from an analysis of 13,457 men – representing 0.9% of all breast cancers – and 1,439,866 women with breast cancer in the National Cancer Data Base spanning the years 1998 through 2007. The explanation for the differences in overall survival is most likely multifactorial, according to Dr. Greif.

"Certainly, one reason is that with well accepted screening for female breast cancer, and heightened awareness amongst women, female breast cancer is detected earlier. Evidence from our study is that male breast cancer is larger and more likely to have spread to lymph nodes and beyond when first discovered," he said in an interview.

"However, male breast cancer was less likely to be low grade, and this would be a biological difference. And, finally, men were older, and more likely to die of other causes."

Men at particularly high risk should have careful clinical examinations annually, and consider annual screening mammography, advised Dr. Greif. Among those at high risk, he included men with known gene mutations that increase their risk (BRCA and Klinefelter’s syndrome, for example), men who have been treated or otherwise exposed to high levels of radiation to the chest, men with previous breast cancer, and men with strong family histories of male or female breast cancer.

"Currently, breast cancer in men is found as a palpable retro- or periareolar mass, a nipple discharge or crusting, skin erosion, or palpable lymph nodes. Examination of the retroareolar and periareolar tissues for lumps and/or skin changes should be a part of every man’s annual physical exam, and men should check occasionally themselves," Dr. Greif said.

Five-year overall survival was 83% for women with breast cancer (median survival 129 months) and 74% for men (median 101 months), a highly statistically significant difference (P less than. 0001), he reported.

A comparison of overall survival by stages showed significantly better outcomes for women with early disease, but similar outcomes in more advanced disease. Females had significantly better 5-year survival rates (P less than .0001) for stage 0 (94% vs. 90%), stage I (90% vs. 87%) and stage II (82% vs. 74%) breast cancer. No significant differences were seen in 5-year survival for stage III (56.9% vs. 56.5%, P = .99) or stage IV (19% vs. 16%, P = .20).

The following findings also were reported:

– Men with breast cancer were more often African American (11.7% vs. 9.9%, odds ratio 1.19), less often Hispanic (3.6% vs. 4.5%, OR 0.74), and older (63 vs. 59 years old).

– Men had larger tumors (median 20.0 vs. 15.0 mm), were less likely to have grade 1 tumors (16.0% vs. 20.7%), were more likely to have lymph node metastasis (41.9% vs. 33.2%, OR 1.45), and were more likely to have distant metastasis (4% vs. 3%, OR 1.39).

– Men were less likely to have lobular carcinoma (10% vs. 18%, OR 0.51) and more likely to be estrogen receptor positive (88.3% vs. 78.2%, OR 2.10) and progesterone receptor positive (76.8% vs. 67.0%, OR 1.63).

– Men were less likely to have been treated with a partial mastectomy (33% vs. 62%, OR 0.31) and less likely to have received radiation (35.9% vs. 50.4%, OR 0.55).

All of these differences were highly statistically significant, with P values less than .0001. However, the differences may not have been of clinical significance, the investigators said, citing the large numbers of cases.

The proportions of men and women receiving chemotherapy were similar (40.1% vs. 39.8%, OR 1.01, P = .40) and only small differences were seen in hormonal therapy rates (41.2% vs. 42.4%, OR 0.95, P = .006).

Treatment of male breast cancer is similar to that of female breast cancer, according to Dr. Greif. Nearly all male breast cancers are hormone receptor positive, so treatment with antiestrogenic endocrine therapy should be a part of the adjuvant treatment of nearly all male breast cancer.

Chemotherapy should be considered for tumors with higher risk of systemic return, he said. For tumors with risk of locoregional return, including those that are large and/or have lymph node involvement, adjuvant radiation should be part of the treatment.

The surgery for male breast cancer is almost always total mastectomy, he noted, and there is evidence that sentinel lymph node biopsy works for male breast cancer as well as in female breast cancer.

This study was funded in part by Alta Bates Summit Medical Center. None of the authors have any conflicts of interest or financial disclosures.

WASHINGTON – More than one in 10 admissions to an acute psychiatric inpatient geriatric psychiatry service was associated with an alcohol or drug use disorder in a retrospective examination of admissions for 1,788 patients over age 65 who were seen from 2001 to 2011.

"With more than 1 in 10 elderly patients meeting criteria for a substance use diagnosis in this population, clinicians should increase surveillance at all patient encounters in an effort to reduce the associated morbidity and mortality and improve functional status and quality of life for these individuals," Dr. Dennis Dombrowski said in an interview.

The total group had a mean age of 75.45 years and an average length of stay of 13.91 days. Of all 1,788 admissions, 11.7% (210) were associated with at least one substance abuse diagnosis. The most common was alcohol abuse, identified in 73% of the 210. Other substance abuse diagnoses included sedative hypnotic abuse/dependence in 11%, opiate abuse/dependence in 3%, cannabis use in 1%, tobacco use disorder in 1%, and unspecified drug-induced disorders/withdrawal in 39%. (The total is greater than 100% because some patients had more than one diagnosis.)

Compared with the psychiatric patients without substance abuse diagnoses, those who had at least one were significantly younger, were more likely to be male, had shorter lengths of stay, were readmitted less frequently, and were more likely to be divorced, he reported in a poster presentation at the annual meeting of the American Association for Geriatric Psychiatry.

Although the primary reason for admission could not be ascertained because of the limitations of the database, the most frequent Axis I comorbid diagnoses were recurrent major depression in 26%, bipolar disorder type 1 in 10.5%, vascular dementia in 10%, Alzheimer’s-type dementia in 7%, adjustment disorder in 7%, delirium in 5%, and generalized anxiety disorder in 3%.

Dr. Dombrowski of the University of Virginia, Charlottesville, said that these findings most likely underrepresent the problem. Although substance abuse history is routinely solicited from all new admissions, "substance abuse is likely grossly underappreciated in this population secondary to reluctance of self report, inaccuracy of self report, health care provider attitudes, and also the different social circumstances of elderly patients as compared to younger substance abusers who might be more easily identified secondary to declining occupational or social functioning," he noted.

Moreover, there is a relative dearth of validated screening tools for identifying substance abuse in this patient population. Although they are probably underrecognized clinically, high morbidity and mortality are associated with substance abuse in the older population, including increased risk of falls, delirium, and suicide, he said.

Dr. Dombrowski has no disclosures

WASHINGTON – More than one in 10 admissions to an acute psychiatric inpatient geriatric psychiatry service was associated with an alcohol or drug use disorder in a retrospective examination of admissions for 1,788 patients over age 65 who were seen from 2001 to 2011.

"With more than 1 in 10 elderly patients meeting criteria for a substance use diagnosis in this population, clinicians should increase surveillance at all patient encounters in an effort to reduce the associated morbidity and mortality and improve functional status and quality of life for these individuals," Dr. Dennis Dombrowski said in an interview.

The total group had a mean age of 75.45 years and an average length of stay of 13.91 days. Of all 1,788 admissions, 11.7% (210) were associated with at least one substance abuse diagnosis. The most common was alcohol abuse, identified in 73% of the 210. Other substance abuse diagnoses included sedative hypnotic abuse/dependence in 11%, opiate abuse/dependence in 3%, cannabis use in 1%, tobacco use disorder in 1%, and unspecified drug-induced disorders/withdrawal in 39%. (The total is greater than 100% because some patients had more than one diagnosis.)

Compared with the psychiatric patients without substance abuse diagnoses, those who had at least one were significantly younger, were more likely to be male, had shorter lengths of stay, were readmitted less frequently, and were more likely to be divorced, he reported in a poster presentation at the annual meeting of the American Association for Geriatric Psychiatry.

Although the primary reason for admission could not be ascertained because of the limitations of the database, the most frequent Axis I comorbid diagnoses were recurrent major depression in 26%, bipolar disorder type 1 in 10.5%, vascular dementia in 10%, Alzheimer’s-type dementia in 7%, adjustment disorder in 7%, delirium in 5%, and generalized anxiety disorder in 3%.

Dr. Dombrowski of the University of Virginia, Charlottesville, said that these findings most likely underrepresent the problem. Although substance abuse history is routinely solicited from all new admissions, "substance abuse is likely grossly underappreciated in this population secondary to reluctance of self report, inaccuracy of self report, health care provider attitudes, and also the different social circumstances of elderly patients as compared to younger substance abusers who might be more easily identified secondary to declining occupational or social functioning," he noted.

Moreover, there is a relative dearth of validated screening tools for identifying substance abuse in this patient population. Although they are probably underrecognized clinically, high morbidity and mortality are associated with substance abuse in the older population, including increased risk of falls, delirium, and suicide, he said.

Dr. Dombrowski has no disclosures

WASHINGTON – More than one in 10 admissions to an acute psychiatric inpatient geriatric psychiatry service was associated with an alcohol or drug use disorder in a retrospective examination of admissions for 1,788 patients over age 65 who were seen from 2001 to 2011.

"With more than 1 in 10 elderly patients meeting criteria for a substance use diagnosis in this population, clinicians should increase surveillance at all patient encounters in an effort to reduce the associated morbidity and mortality and improve functional status and quality of life for these individuals," Dr. Dennis Dombrowski said in an interview.

The total group had a mean age of 75.45 years and an average length of stay of 13.91 days. Of all 1,788 admissions, 11.7% (210) were associated with at least one substance abuse diagnosis. The most common was alcohol abuse, identified in 73% of the 210. Other substance abuse diagnoses included sedative hypnotic abuse/dependence in 11%, opiate abuse/dependence in 3%, cannabis use in 1%, tobacco use disorder in 1%, and unspecified drug-induced disorders/withdrawal in 39%. (The total is greater than 100% because some patients had more than one diagnosis.)

Compared with the psychiatric patients without substance abuse diagnoses, those who had at least one were significantly younger, were more likely to be male, had shorter lengths of stay, were readmitted less frequently, and were more likely to be divorced, he reported in a poster presentation at the annual meeting of the American Association for Geriatric Psychiatry.

Although the primary reason for admission could not be ascertained because of the limitations of the database, the most frequent Axis I comorbid diagnoses were recurrent major depression in 26%, bipolar disorder type 1 in 10.5%, vascular dementia in 10%, Alzheimer’s-type dementia in 7%, adjustment disorder in 7%, delirium in 5%, and generalized anxiety disorder in 3%.

Dr. Dombrowski of the University of Virginia, Charlottesville, said that these findings most likely underrepresent the problem. Although substance abuse history is routinely solicited from all new admissions, "substance abuse is likely grossly underappreciated in this population secondary to reluctance of self report, inaccuracy of self report, health care provider attitudes, and also the different social circumstances of elderly patients as compared to younger substance abusers who might be more easily identified secondary to declining occupational or social functioning," he noted.

Moreover, there is a relative dearth of validated screening tools for identifying substance abuse in this patient population. Although they are probably underrecognized clinically, high morbidity and mortality are associated with substance abuse in the older population, including increased risk of falls, delirium, and suicide, he said.

Dr. Dombrowski has no disclosures

ORLANDO – Gastroesophageal reflux disease was associated with prior wheezing and greater severity of infant acute respiratory illness in a study involving 430 term, healthy infants presenting with acute respiratory illness due to bronchiolitis or upper respiratory infection.

New-onset gastroesophageal reflux disease (GERD) during bronchiolitis in previously health infants has been shown to increase the risk for respiratory failure (Acta Paediatr. 2007;96:1025-9). Bronchiolitis is a prominent risk factor for childhood asthma, and GERD is associated with worsened asthma severity (J. Asthma 2011;48:366-73). As yet unknown is whether preexisting GERD (clinically significant reflux) in infants modulates the severity of infant bronchiolitis or the diagnosis of childhood asthma, Dr. Robert S. Valet of Vanderbilt University, Nashville, Tenn., and his associates said in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The 430 infants, aged 0-12 months, were enrolled in the Tennessee Children\'s Respiratory Initiative. The presence of infant GERD was defined by parental report with an answer of "yes" to the question, "Does your child have a history of gastroesophageal reflux disease?"

In all, 45 infants (10%) were reported to have GERD. They were more likely than those without GERD to be white and to have a family history of allergic rhinitis, but did not differ by age at illness, secondhand smoke (SHS) exposure, or family history of asthma. The group with GERD was significantly more likely to have previous treatment for wheeze (42% vs. 25%), and to have bronchiolitis (84% vs. 71%).

The median bronchiolitis severity score (range, 0-12; higher score indicates more severe disease, with a difference of 0.5 being clinically meaningful) in univariate analysis was 5.5 in the GERD group vs. 4.0 in infants without GERD. Adjusting for age, race, sex, and SHS, the increased bronchiolitis severity score in the GERD group persisted (odds ratio, 1.90). Although not significant, 11% of infants with GERD vs. 5% of non-GERD infants needed ICU care, Dr. Valet and his associates reported.

Preexisting GERD was associated with increased bronchiolitis severity and increased recurrent wheezing illness at 2 years, at which time 69% of infants with GERD and 46% of those without GERD had experienced wheeze since initial study enrollment (OR, 2.35; P = .006). And although not statistically significant, 52% with GERD vs. 40% without had used albuterol in this time period (P = .13). However, there was no difference in asthma diagnosis at age 2 years; 24% of infants with GERD were diagnosed with asthma by age 2, compared with 22% of those without GERD (P = .76).

This is the first time that preexisting infant GERD has been associated with increased bronchiolitis severity, Dr. Valet noted. Future study could investigate whether treating infant GERD decreases both bronchiolitis and asthma severity. "These findings should be replicated using a more rigorous assessment of GERD," he concluded.

The study was funded by the Thrasher Research Fund. Dr. Valet said he had no relevant financial disclosures.

ORLANDO – Gastroesophageal reflux disease was associated with prior wheezing and greater severity of infant acute respiratory illness in a study involving 430 term, healthy infants presenting with acute respiratory illness due to bronchiolitis or upper respiratory infection.

New-onset gastroesophageal reflux disease (GERD) during bronchiolitis in previously health infants has been shown to increase the risk for respiratory failure (Acta Paediatr. 2007;96:1025-9). Bronchiolitis is a prominent risk factor for childhood asthma, and GERD is associated with worsened asthma severity (J. Asthma 2011;48:366-73). As yet unknown is whether preexisting GERD (clinically significant reflux) in infants modulates the severity of infant bronchiolitis or the diagnosis of childhood asthma, Dr. Robert S. Valet of Vanderbilt University, Nashville, Tenn., and his associates said in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The 430 infants, aged 0-12 months, were enrolled in the Tennessee Children\'s Respiratory Initiative. The presence of infant GERD was defined by parental report with an answer of "yes" to the question, "Does your child have a history of gastroesophageal reflux disease?"

In all, 45 infants (10%) were reported to have GERD. They were more likely than those without GERD to be white and to have a family history of allergic rhinitis, but did not differ by age at illness, secondhand smoke (SHS) exposure, or family history of asthma. The group with GERD was significantly more likely to have previous treatment for wheeze (42% vs. 25%), and to have bronchiolitis (84% vs. 71%).

The median bronchiolitis severity score (range, 0-12; higher score indicates more severe disease, with a difference of 0.5 being clinically meaningful) in univariate analysis was 5.5 in the GERD group vs. 4.0 in infants without GERD. Adjusting for age, race, sex, and SHS, the increased bronchiolitis severity score in the GERD group persisted (odds ratio, 1.90). Although not significant, 11% of infants with GERD vs. 5% of non-GERD infants needed ICU care, Dr. Valet and his associates reported.

Preexisting GERD was associated with increased bronchiolitis severity and increased recurrent wheezing illness at 2 years, at which time 69% of infants with GERD and 46% of those without GERD had experienced wheeze since initial study enrollment (OR, 2.35; P = .006). And although not statistically significant, 52% with GERD vs. 40% without had used albuterol in this time period (P = .13). However, there was no difference in asthma diagnosis at age 2 years; 24% of infants with GERD were diagnosed with asthma by age 2, compared with 22% of those without GERD (P = .76).

This is the first time that preexisting infant GERD has been associated with increased bronchiolitis severity, Dr. Valet noted. Future study could investigate whether treating infant GERD decreases both bronchiolitis and asthma severity. "These findings should be replicated using a more rigorous assessment of GERD," he concluded.

The study was funded by the Thrasher Research Fund. Dr. Valet said he had no relevant financial disclosures.

ORLANDO – Gastroesophageal reflux disease was associated with prior wheezing and greater severity of infant acute respiratory illness in a study involving 430 term, healthy infants presenting with acute respiratory illness due to bronchiolitis or upper respiratory infection.

New-onset gastroesophageal reflux disease (GERD) during bronchiolitis in previously health infants has been shown to increase the risk for respiratory failure (Acta Paediatr. 2007;96:1025-9). Bronchiolitis is a prominent risk factor for childhood asthma, and GERD is associated with worsened asthma severity (J. Asthma 2011;48:366-73). As yet unknown is whether preexisting GERD (clinically significant reflux) in infants modulates the severity of infant bronchiolitis or the diagnosis of childhood asthma, Dr. Robert S. Valet of Vanderbilt University, Nashville, Tenn., and his associates said in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The 430 infants, aged 0-12 months, were enrolled in the Tennessee Children\'s Respiratory Initiative. The presence of infant GERD was defined by parental report with an answer of "yes" to the question, "Does your child have a history of gastroesophageal reflux disease?"

In all, 45 infants (10%) were reported to have GERD. They were more likely than those without GERD to be white and to have a family history of allergic rhinitis, but did not differ by age at illness, secondhand smoke (SHS) exposure, or family history of asthma. The group with GERD was significantly more likely to have previous treatment for wheeze (42% vs. 25%), and to have bronchiolitis (84% vs. 71%).

The median bronchiolitis severity score (range, 0-12; higher score indicates more severe disease, with a difference of 0.5 being clinically meaningful) in univariate analysis was 5.5 in the GERD group vs. 4.0 in infants without GERD. Adjusting for age, race, sex, and SHS, the increased bronchiolitis severity score in the GERD group persisted (odds ratio, 1.90). Although not significant, 11% of infants with GERD vs. 5% of non-GERD infants needed ICU care, Dr. Valet and his associates reported.

Preexisting GERD was associated with increased bronchiolitis severity and increased recurrent wheezing illness at 2 years, at which time 69% of infants with GERD and 46% of those without GERD had experienced wheeze since initial study enrollment (OR, 2.35; P = .006). And although not statistically significant, 52% with GERD vs. 40% without had used albuterol in this time period (P = .13). However, there was no difference in asthma diagnosis at age 2 years; 24% of infants with GERD were diagnosed with asthma by age 2, compared with 22% of those without GERD (P = .76).

This is the first time that preexisting infant GERD has been associated with increased bronchiolitis severity, Dr. Valet noted. Future study could investigate whether treating infant GERD decreases both bronchiolitis and asthma severity. "These findings should be replicated using a more rigorous assessment of GERD," he concluded.

The study was funded by the Thrasher Research Fund. Dr. Valet said he had no relevant financial disclosures.

ORLANDO – Budesonide/formoterol pressurized metered-dose inhaler demonstrated similar cardiovascular safety to that of budesonide treatment alone in a study of 742 black adolescents and adults with moderate to severe asthma.

There has been concern that regular long-acting beta₂-adrenergic agonist (LABA) therapy may increase the risk of mortality, including that from cardiac adverse events. An analysis of asthma trials suggested that formoterol does not increase cardiac-related serious adverse events or cardiac-related deaths (Eur. Respir. J. 2009;33:21-32).

And a recent study showed that budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) was well tolerated and more effective for preventing exacerbations, compared with monotherapy BUD pMDI, in a black patient population (Am. J. Respir. Crit. Care Med. 2011;183:A1294).

However, data have been limited on the cardiovascular safety of combination inhaled corticosteroids (ICSs) and LABAs in specific racial/ethnic patient populations with asthma, Dr. Kathy L. Lampl of AstraZeneca and her associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a randomized, double-blind, parallel-group, multicenter, 52-week study, 742 patients with moderate to severe persistent asthma who self-reported their race as black were randomized 1:1 to receive BUD/FM pMDI (160/4.5 mcg × 2 inhalations, total 320/9 mcg) or BUD pMDI (160 mcg × 2 inhalations, total 320 mcg) twice daily. Twelve-lead electrocardiograms were obtained before the morning dose of study medication in all patients at visits two through nine.

All patients were on a consistent daily medium to high dose of ICS either taken alone or as combination therapy with a LABA for 30 days or longer before screening.

Changes from baseline to treatment maximum for BUD/FM vs. BUD were similar for heart rate (9.87 vs. 9.04 beats/minute) and QT interval corrected for heart rate, with QTc 18.46 vs. 18.18 msec (Bazett’s correction) and QTc 13.47 vs. 14.73 msec (Fridericia’s correction), but lower for the uncorrected QT interval, 15.59 vs. 19.12 msec (unadjusted P = .002).

The proportion of patients with a heart rate greater than 100 beats/min or an increase of 20 or more beats per minute were 11.4% for BUD/FM and 8.5% for BUD, which is consistent with known effects of beta₂-adrenergic agonists, Dr. Lampl and her associates said.

Cardiac events were infrequent, and all were considered nonserious. Cardiac adverse events occurred in six patients (1.6%) in the BUD/FM pMDI group, including cardiac conduction disorders (one patient, 0.3%), ischemic coronary artery disorders (one patient, 0.3%), rate and rhythm disorders (two patients, 0.5%), supraventricular arrhythmias (two patients, 0.5%), and ventricular arrhythmias and cardiac arrest (one patient, 0.3%). Four patients (1.1%) in the BUD pMDI group experienced a cardiac adverse event, including cardiac conduction disorders (two patients, 0.5%), cardiac signs and symptoms (one patient, 0.3%), and noninfectious pericarditis (one patient, 0.3%).

"Overall, the results of this study further support the long-term tolerability of BUD/FM pMDI in African-American adolescents and adults with moderate to severe asthma not adequately controlled on an ICS alone," Dr. Lampl and her associates concluded.

Dr. Lampl is a paid employee of AstraZeneca, which funded the study.

ORLANDO – Budesonide/formoterol pressurized metered-dose inhaler demonstrated similar cardiovascular safety to that of budesonide treatment alone in a study of 742 black adolescents and adults with moderate to severe asthma.

There has been concern that regular long-acting beta₂-adrenergic agonist (LABA) therapy may increase the risk of mortality, including that from cardiac adverse events. An analysis of asthma trials suggested that formoterol does not increase cardiac-related serious adverse events or cardiac-related deaths (Eur. Respir. J. 2009;33:21-32).

And a recent study showed that budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) was well tolerated and more effective for preventing exacerbations, compared with monotherapy BUD pMDI, in a black patient population (Am. J. Respir. Crit. Care Med. 2011;183:A1294).

However, data have been limited on the cardiovascular safety of combination inhaled corticosteroids (ICSs) and LABAs in specific racial/ethnic patient populations with asthma, Dr. Kathy L. Lampl of AstraZeneca and her associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a randomized, double-blind, parallel-group, multicenter, 52-week study, 742 patients with moderate to severe persistent asthma who self-reported their race as black were randomized 1:1 to receive BUD/FM pMDI (160/4.5 mcg × 2 inhalations, total 320/9 mcg) or BUD pMDI (160 mcg × 2 inhalations, total 320 mcg) twice daily. Twelve-lead electrocardiograms were obtained before the morning dose of study medication in all patients at visits two through nine.

All patients were on a consistent daily medium to high dose of ICS either taken alone or as combination therapy with a LABA for 30 days or longer before screening.

Changes from baseline to treatment maximum for BUD/FM vs. BUD were similar for heart rate (9.87 vs. 9.04 beats/minute) and QT interval corrected for heart rate, with QTc 18.46 vs. 18.18 msec (Bazett’s correction) and QTc 13.47 vs. 14.73 msec (Fridericia’s correction), but lower for the uncorrected QT interval, 15.59 vs. 19.12 msec (unadjusted P = .002).

The proportion of patients with a heart rate greater than 100 beats/min or an increase of 20 or more beats per minute were 11.4% for BUD/FM and 8.5% for BUD, which is consistent with known effects of beta₂-adrenergic agonists, Dr. Lampl and her associates said.

Cardiac events were infrequent, and all were considered nonserious. Cardiac adverse events occurred in six patients (1.6%) in the BUD/FM pMDI group, including cardiac conduction disorders (one patient, 0.3%), ischemic coronary artery disorders (one patient, 0.3%), rate and rhythm disorders (two patients, 0.5%), supraventricular arrhythmias (two patients, 0.5%), and ventricular arrhythmias and cardiac arrest (one patient, 0.3%). Four patients (1.1%) in the BUD pMDI group experienced a cardiac adverse event, including cardiac conduction disorders (two patients, 0.5%), cardiac signs and symptoms (one patient, 0.3%), and noninfectious pericarditis (one patient, 0.3%).

"Overall, the results of this study further support the long-term tolerability of BUD/FM pMDI in African-American adolescents and adults with moderate to severe asthma not adequately controlled on an ICS alone," Dr. Lampl and her associates concluded.

Dr. Lampl is a paid employee of AstraZeneca, which funded the study.

ORLANDO – Budesonide/formoterol pressurized metered-dose inhaler demonstrated similar cardiovascular safety to that of budesonide treatment alone in a study of 742 black adolescents and adults with moderate to severe asthma.

There has been concern that regular long-acting beta₂-adrenergic agonist (LABA) therapy may increase the risk of mortality, including that from cardiac adverse events. An analysis of asthma trials suggested that formoterol does not increase cardiac-related serious adverse events or cardiac-related deaths (Eur. Respir. J. 2009;33:21-32).

And a recent study showed that budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) was well tolerated and more effective for preventing exacerbations, compared with monotherapy BUD pMDI, in a black patient population (Am. J. Respir. Crit. Care Med. 2011;183:A1294).

However, data have been limited on the cardiovascular safety of combination inhaled corticosteroids (ICSs) and LABAs in specific racial/ethnic patient populations with asthma, Dr. Kathy L. Lampl of AstraZeneca and her associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a randomized, double-blind, parallel-group, multicenter, 52-week study, 742 patients with moderate to severe persistent asthma who self-reported their race as black were randomized 1:1 to receive BUD/FM pMDI (160/4.5 mcg × 2 inhalations, total 320/9 mcg) or BUD pMDI (160 mcg × 2 inhalations, total 320 mcg) twice daily. Twelve-lead electrocardiograms were obtained before the morning dose of study medication in all patients at visits two through nine.

All patients were on a consistent daily medium to high dose of ICS either taken alone or as combination therapy with a LABA for 30 days or longer before screening.

Changes from baseline to treatment maximum for BUD/FM vs. BUD were similar for heart rate (9.87 vs. 9.04 beats/minute) and QT interval corrected for heart rate, with QTc 18.46 vs. 18.18 msec (Bazett’s correction) and QTc 13.47 vs. 14.73 msec (Fridericia’s correction), but lower for the uncorrected QT interval, 15.59 vs. 19.12 msec (unadjusted P = .002).

The proportion of patients with a heart rate greater than 100 beats/min or an increase of 20 or more beats per minute were 11.4% for BUD/FM and 8.5% for BUD, which is consistent with known effects of beta₂-adrenergic agonists, Dr. Lampl and her associates said.

Cardiac events were infrequent, and all were considered nonserious. Cardiac adverse events occurred in six patients (1.6%) in the BUD/FM pMDI group, including cardiac conduction disorders (one patient, 0.3%), ischemic coronary artery disorders (one patient, 0.3%), rate and rhythm disorders (two patients, 0.5%), supraventricular arrhythmias (two patients, 0.5%), and ventricular arrhythmias and cardiac arrest (one patient, 0.3%). Four patients (1.1%) in the BUD pMDI group experienced a cardiac adverse event, including cardiac conduction disorders (two patients, 0.5%), cardiac signs and symptoms (one patient, 0.3%), and noninfectious pericarditis (one patient, 0.3%).

"Overall, the results of this study further support the long-term tolerability of BUD/FM pMDI in African-American adolescents and adults with moderate to severe asthma not adequately controlled on an ICS alone," Dr. Lampl and her associates concluded.

Dr. Lampl is a paid employee of AstraZeneca, which funded the study.

WASHINGTON – Proposed DSM-5 criteria for sleep-wake disorders include dropping the DSM-IV’s "primary insomnia" diagnosis in favor of "insomnia disorder," and decreasing use of the term "not otherwise specified."

The changes reflect a move away from the need to make causal attribution between coexisting disorders and also the overall DSM-5 shift toward more data-driven diagnostic criteria, said Dr. Charles F. Reynolds III, professor of geriatric psychiatry, neurology, and neuroscience at the University of Pittsburgh.

"Sleep-wake disorders" is one of 13 diagnostic categories that are undergoing revision from the DSM-IV to the DSM-5, slated for publication in May 2013. Dr. Reynolds is chair of the seven-member Sleep-Wake Disorders Work Group that devised the proposed diagnostic criteria, which – along with the rest of the DSM-5 proposed criteria – will be open for a third and final round of comments from visitors beginning this spring. As before, comments will be systematically reviewed by each of the work groups for consideration of additional changes.

The proposed criteria are meant to be used by nonpsychiatrists and psychiatrists who are not sleep specialists. "We are trying very much to propose a classification and a set of criteria that are friendly [and] clinically useful for the general mental health clinician and to the general medical clinician, because very few users will have specific expertise in sleep disorders medicine," said Dr. Reynolds, also professor of behavioral and community health sciences at the university’s graduate school of public health. "We don’t think such expertise will be necessary. At the same time, our hope is that with these criteria and with the accompanying text, that the general user will feel more confident about when to consult a sleep disorder specialist."

Sleep disorders per se are frequently accompanied by depression, anxiety, and other cognitive mental status changes that must be addressed in treatment planning and management. The differential diagnosis of complaints such as insomnia and daytime sleepiness necessitates consideration of coexisting medical and neurologic conditions, and requires a multidimensional approach. "Coexisting clinical conditions are the rule, not the exception," he noted.

Proposed Terminology Changes

The proposed DSM-5 criteria replace terminology that causally attributes coexisting conditions with a simple listing of the comorbidities. This was done to underscore that the patient has a sleep disorder warranting independent clinical attention in addition to the psychiatric and medical disorders also present. In addition to the switch from "primary insomnia" to "insomnia disorder," the diagnoses of "sleep disorder related to another mental disorder" and "sleep disorder related to a general medical condition" also are proposed to be dropped in favor of "insomnia disorder" or "hypersomnia disorder," along with specification of clinically comorbid medical and psychiatric conditions.

This approach acknowledges bidirectional or interactive effects between sleep disorders and coexisting psychiatric conditions such as depression. It also has implications for treatment. For example, a patient who has persistent insomnia even after adequate treatment for depression might be at increased risk for relapse of the depression, or for worsening of cognitive impairment, and might therefore require independent evaluation of the sleep problem, Dr. Reynolds noted.

In an effort to improve diagnostic precision, use of "insomnia not otherwise specified" is proposed to be reduced by elevating both "REM sleep behavior disorder" and "restless leg syndrome" to full-fledged diagnoses. This recommendation is based on a large amount of epidemiologic, pathophysiologic, genetic, and controlled clinical trial data, he said.

Another proposal is to further subtype circadian rhythm sleep disorders into delayed sleep phase type; advanced sleep phase type; and irregular sleep–wake type, –free-running type, –jet lag type, and –shift work type. Yet another proposal would subtype breathing-related sleep disorder into obstructive vs. central in order to inform treatment planning.

Other Proposed Modifications

Other major proposed changes include distinguishing narcolepsy/hypocretin deficiency from other forms of hypersomnia disorder, which illustrates the increased emphasis on using biomarkers in the DSM-5 where doing so would be scientifically appropriate and clinically practical, he noted.

An example of the effort to move away from expert opinion to evidence-based diagnostic criteria is the proposed "primary hypersomnia/narcolepsy without cataplexy" category. In the DSM-IV, the criteria are "unexplained hypersomnia (excessive sleep) or/and hypersomnolence (sleepiness in spite of sufficient nocturnal sleep), for at least 3 months, occurring 3 or more times per week," with "hypersomnia" defined by a prolonged nocturnal sleep episode or daily sleep amounts (more than 9 hours/day).

In the proposed DSM-5 revision, the definition of hypersomnia includes thresholds: Excessive sleepiness that occurs three or more times per week, for 3 or more months, despite a main sleep lasting 7 hours or longer. Evidence supporting this comes from a recent cross-sectional telephone survey of 15,929 individuals who were representative of the adult general population of 15 U.S. states. A total of 27.8% reported "excessive sleepiness," and 15.6% had recurrent periods of irrepressible need to sleep or to nap within the same day (13.2%); recurrent naps within the same day (1.9%); a nonrestorative (unrefreshing), prolonged main sleep episode of 9 hours or more per day (0.7%); and/or confusional arousals (sleep drunkenness) (4.4%).

Adding in the "excessive sleep" definition – frequency of at least three times per week for at least 3 months, despite normal sleep duration – dropped the hypersomnia disorder prevalence to 4.7% of the sample. Adding in "significant distress or impairment in cognitive, social, occupational, or other important areas of functioning" further dropped the prevalence to 2.6%, and the differential "hypersomnia is not better accounted for or does not occur exclusively during the course of another sleep disorder" gave a final prevalence of 1.5% (Arch. Gen. Psychiatry 2012;69:71-9).

"This is a threshold for significant daytime distress/impairment that warrants diagnosis. This kind of empirical basis is something we’ve pursued throughout DSM-5 in order to make it less dependent on expert opinion and be more data driven," Dr. Reynolds commented.

Insomnia Disorder 307.42

According to the Sleep-Wake Disorders Work Group, the following is the proposed wording of the new criteria:

A. The predominant complaint is a global sleep dissatisfaction with one or more of the following symptoms:

1. Difficulty initiating sleep (in children: without caregiver intervention).

2. Difficulty maintaining sleep (e.g., frequent or prolonged awakenings with difficulty returning to sleep) (in children: without caregiver intervention).

3. Early morning awakening (e.g., premature awakening with inability to return to sleep).

4. Nonrestorative sleep (adults).

5. Resistance to going to bed (children).

B. The sleep complaint is accompanied by significant distress or impairment in social, occupational, or other important areas of functioning as indicated by the presence of at least one of the following:

1. Fatigue or low energy.

2. Daytime sleepiness.

3. Cognitive impairments (e.g., attention, concentration, memory).

4. Mood disturbance (e.g., irritability, dysphoria).

5. Behavioral problems in children (hyperactivity, impulsivity, aggression).

6. Impaired occupational function.

7. Impaired interpersonal/social function.

8. Impaired academic function (children).

9. Negative impact on caregiver or family function (children).

C. The sleep difficulty is present for at least 3 months (empirical basis to address severity of the complaint).

D. The sleep difficulty occurs despite adequate age-appropriate circumstances and opportunity for sleep. Clinically comorbid Conditions, (may warrant individual work-up/attention):

1. Mental/psychiatric disorder (specify).

2. Medical disorder (specify).

3. Another disorder (specify).

E. The sleep difficulty occurs at least 3 nights per week.

Dr. Reynolds disclosed that he has received funding from the National Institute of Mental Health; the National Institute on Aging; the National Center on Minority Health and Health Disparities; the National Heart, Lung, and Blood Institute; the John A. Hartford Foundation; the American Foundation for Suicide Prevention; the Commonwealth of Pennsylvania; and the UPMC Endowment in Geriatric Psychiatry. Forest Laboratories, Pfizer, Lilly, and Bristol-Myers Squibb have provided pharmaceuticals for his National Institutes of Health–sponsored research.

WASHINGTON – Proposed DSM-5 criteria for sleep-wake disorders include dropping the DSM-IV’s "primary insomnia" diagnosis in favor of "insomnia disorder," and decreasing use of the term "not otherwise specified."

The changes reflect a move away from the need to make causal attribution between coexisting disorders and also the overall DSM-5 shift toward more data-driven diagnostic criteria, said Dr. Charles F. Reynolds III, professor of geriatric psychiatry, neurology, and neuroscience at the University of Pittsburgh.

"Sleep-wake disorders" is one of 13 diagnostic categories that are undergoing revision from the DSM-IV to the DSM-5, slated for publication in May 2013. Dr. Reynolds is chair of the seven-member Sleep-Wake Disorders Work Group that devised the proposed diagnostic criteria, which – along with the rest of the DSM-5 proposed criteria – will be open for a third and final round of comments from visitors beginning this spring. As before, comments will be systematically reviewed by each of the work groups for consideration of additional changes.

The proposed criteria are meant to be used by nonpsychiatrists and psychiatrists who are not sleep specialists. "We are trying very much to propose a classification and a set of criteria that are friendly [and] clinically useful for the general mental health clinician and to the general medical clinician, because very few users will have specific expertise in sleep disorders medicine," said Dr. Reynolds, also professor of behavioral and community health sciences at the university’s graduate school of public health. "We don’t think such expertise will be necessary. At the same time, our hope is that with these criteria and with the accompanying text, that the general user will feel more confident about when to consult a sleep disorder specialist."

Sleep disorders per se are frequently accompanied by depression, anxiety, and other cognitive mental status changes that must be addressed in treatment planning and management. The differential diagnosis of complaints such as insomnia and daytime sleepiness necessitates consideration of coexisting medical and neurologic conditions, and requires a multidimensional approach. "Coexisting clinical conditions are the rule, not the exception," he noted.

Proposed Terminology Changes

The proposed DSM-5 criteria replace terminology that causally attributes coexisting conditions with a simple listing of the comorbidities. This was done to underscore that the patient has a sleep disorder warranting independent clinical attention in addition to the psychiatric and medical disorders also present. In addition to the switch from "primary insomnia" to "insomnia disorder," the diagnoses of "sleep disorder related to another mental disorder" and "sleep disorder related to a general medical condition" also are proposed to be dropped in favor of "insomnia disorder" or "hypersomnia disorder," along with specification of clinically comorbid medical and psychiatric conditions.

This approach acknowledges bidirectional or interactive effects between sleep disorders and coexisting psychiatric conditions such as depression. It also has implications for treatment. For example, a patient who has persistent insomnia even after adequate treatment for depression might be at increased risk for relapse of the depression, or for worsening of cognitive impairment, and might therefore require independent evaluation of the sleep problem, Dr. Reynolds noted.

In an effort to improve diagnostic precision, use of "insomnia not otherwise specified" is proposed to be reduced by elevating both "REM sleep behavior disorder" and "restless leg syndrome" to full-fledged diagnoses. This recommendation is based on a large amount of epidemiologic, pathophysiologic, genetic, and controlled clinical trial data, he said.

Another proposal is to further subtype circadian rhythm sleep disorders into delayed sleep phase type; advanced sleep phase type; and irregular sleep–wake type, –free-running type, –jet lag type, and –shift work type. Yet another proposal would subtype breathing-related sleep disorder into obstructive vs. central in order to inform treatment planning.

Other Proposed Modifications

Other major proposed changes include distinguishing narcolepsy/hypocretin deficiency from other forms of hypersomnia disorder, which illustrates the increased emphasis on using biomarkers in the DSM-5 where doing so would be scientifically appropriate and clinically practical, he noted.

An example of the effort to move away from expert opinion to evidence-based diagnostic criteria is the proposed "primary hypersomnia/narcolepsy without cataplexy" category. In the DSM-IV, the criteria are "unexplained hypersomnia (excessive sleep) or/and hypersomnolence (sleepiness in spite of sufficient nocturnal sleep), for at least 3 months, occurring 3 or more times per week," with "hypersomnia" defined by a prolonged nocturnal sleep episode or daily sleep amounts (more than 9 hours/day).

In the proposed DSM-5 revision, the definition of hypersomnia includes thresholds: Excessive sleepiness that occurs three or more times per week, for 3 or more months, despite a main sleep lasting 7 hours or longer. Evidence supporting this comes from a recent cross-sectional telephone survey of 15,929 individuals who were representative of the adult general population of 15 U.S. states. A total of 27.8% reported "excessive sleepiness," and 15.6% had recurrent periods of irrepressible need to sleep or to nap within the same day (13.2%); recurrent naps within the same day (1.9%); a nonrestorative (unrefreshing), prolonged main sleep episode of 9 hours or more per day (0.7%); and/or confusional arousals (sleep drunkenness) (4.4%).

Adding in the "excessive sleep" definition – frequency of at least three times per week for at least 3 months, despite normal sleep duration – dropped the hypersomnia disorder prevalence to 4.7% of the sample. Adding in "significant distress or impairment in cognitive, social, occupational, or other important areas of functioning" further dropped the prevalence to 2.6%, and the differential "hypersomnia is not better accounted for or does not occur exclusively during the course of another sleep disorder" gave a final prevalence of 1.5% (Arch. Gen. Psychiatry 2012;69:71-9).

"This is a threshold for significant daytime distress/impairment that warrants diagnosis. This kind of empirical basis is something we’ve pursued throughout DSM-5 in order to make it less dependent on expert opinion and be more data driven," Dr. Reynolds commented.

Insomnia Disorder 307.42

According to the Sleep-Wake Disorders Work Group, the following is the proposed wording of the new criteria:

A. The predominant complaint is a global sleep dissatisfaction with one or more of the following symptoms:

1. Difficulty initiating sleep (in children: without caregiver intervention).

2. Difficulty maintaining sleep (e.g., frequent or prolonged awakenings with difficulty returning to sleep) (in children: without caregiver intervention).

3. Early morning awakening (e.g., premature awakening with inability to return to sleep).

4. Nonrestorative sleep (adults).

5. Resistance to going to bed (children).

B. The sleep complaint is accompanied by significant distress or impairment in social, occupational, or other important areas of functioning as indicated by the presence of at least one of the following:

1. Fatigue or low energy.

2. Daytime sleepiness.

3. Cognitive impairments (e.g., attention, concentration, memory).

4. Mood disturbance (e.g., irritability, dysphoria).

5. Behavioral problems in children (hyperactivity, impulsivity, aggression).

6. Impaired occupational function.

7. Impaired interpersonal/social function.

8. Impaired academic function (children).

9. Negative impact on caregiver or family function (children).

C. The sleep difficulty is present for at least 3 months (empirical basis to address severity of the complaint).

D. The sleep difficulty occurs despite adequate age-appropriate circumstances and opportunity for sleep. Clinically comorbid Conditions, (may warrant individual work-up/attention):

1. Mental/psychiatric disorder (specify).

2. Medical disorder (specify).

3. Another disorder (specify).

E. The sleep difficulty occurs at least 3 nights per week.

Dr. Reynolds disclosed that he has received funding from the National Institute of Mental Health; the National Institute on Aging; the National Center on Minority Health and Health Disparities; the National Heart, Lung, and Blood Institute; the John A. Hartford Foundation; the American Foundation for Suicide Prevention; the Commonwealth of Pennsylvania; and the UPMC Endowment in Geriatric Psychiatry. Forest Laboratories, Pfizer, Lilly, and Bristol-Myers Squibb have provided pharmaceuticals for his National Institutes of Health–sponsored research.

WASHINGTON – Proposed DSM-5 criteria for sleep-wake disorders include dropping the DSM-IV’s "primary insomnia" diagnosis in favor of "insomnia disorder," and decreasing use of the term "not otherwise specified."

The changes reflect a move away from the need to make causal attribution between coexisting disorders and also the overall DSM-5 shift toward more data-driven diagnostic criteria, said Dr. Charles F. Reynolds III, professor of geriatric psychiatry, neurology, and neuroscience at the University of Pittsburgh.

"Sleep-wake disorders" is one of 13 diagnostic categories that are undergoing revision from the DSM-IV to the DSM-5, slated for publication in May 2013. Dr. Reynolds is chair of the seven-member Sleep-Wake Disorders Work Group that devised the proposed diagnostic criteria, which – along with the rest of the DSM-5 proposed criteria – will be open for a third and final round of comments from visitors beginning this spring. As before, comments will be systematically reviewed by each of the work groups for consideration of additional changes.

The proposed criteria are meant to be used by nonpsychiatrists and psychiatrists who are not sleep specialists. "We are trying very much to propose a classification and a set of criteria that are friendly [and] clinically useful for the general mental health clinician and to the general medical clinician, because very few users will have specific expertise in sleep disorders medicine," said Dr. Reynolds, also professor of behavioral and community health sciences at the university’s graduate school of public health. "We don’t think such expertise will be necessary. At the same time, our hope is that with these criteria and with the accompanying text, that the general user will feel more confident about when to consult a sleep disorder specialist."

Sleep disorders per se are frequently accompanied by depression, anxiety, and other cognitive mental status changes that must be addressed in treatment planning and management. The differential diagnosis of complaints such as insomnia and daytime sleepiness necessitates consideration of coexisting medical and neurologic conditions, and requires a multidimensional approach. "Coexisting clinical conditions are the rule, not the exception," he noted.

Proposed Terminology Changes

The proposed DSM-5 criteria replace terminology that causally attributes coexisting conditions with a simple listing of the comorbidities. This was done to underscore that the patient has a sleep disorder warranting independent clinical attention in addition to the psychiatric and medical disorders also present. In addition to the switch from "primary insomnia" to "insomnia disorder," the diagnoses of "sleep disorder related to another mental disorder" and "sleep disorder related to a general medical condition" also are proposed to be dropped in favor of "insomnia disorder" or "hypersomnia disorder," along with specification of clinically comorbid medical and psychiatric conditions.

This approach acknowledges bidirectional or interactive effects between sleep disorders and coexisting psychiatric conditions such as depression. It also has implications for treatment. For example, a patient who has persistent insomnia even after adequate treatment for depression might be at increased risk for relapse of the depression, or for worsening of cognitive impairment, and might therefore require independent evaluation of the sleep problem, Dr. Reynolds noted.

In an effort to improve diagnostic precision, use of "insomnia not otherwise specified" is proposed to be reduced by elevating both "REM sleep behavior disorder" and "restless leg syndrome" to full-fledged diagnoses. This recommendation is based on a large amount of epidemiologic, pathophysiologic, genetic, and controlled clinical trial data, he said.

Another proposal is to further subtype circadian rhythm sleep disorders into delayed sleep phase type; advanced sleep phase type; and irregular sleep–wake type, –free-running type, –jet lag type, and –shift work type. Yet another proposal would subtype breathing-related sleep disorder into obstructive vs. central in order to inform treatment planning.

Other Proposed Modifications

Other major proposed changes include distinguishing narcolepsy/hypocretin deficiency from other forms of hypersomnia disorder, which illustrates the increased emphasis on using biomarkers in the DSM-5 where doing so would be scientifically appropriate and clinically practical, he noted.

An example of the effort to move away from expert opinion to evidence-based diagnostic criteria is the proposed "primary hypersomnia/narcolepsy without cataplexy" category. In the DSM-IV, the criteria are "unexplained hypersomnia (excessive sleep) or/and hypersomnolence (sleepiness in spite of sufficient nocturnal sleep), for at least 3 months, occurring 3 or more times per week," with "hypersomnia" defined by a prolonged nocturnal sleep episode or daily sleep amounts (more than 9 hours/day).

In the proposed DSM-5 revision, the definition of hypersomnia includes thresholds: Excessive sleepiness that occurs three or more times per week, for 3 or more months, despite a main sleep lasting 7 hours or longer. Evidence supporting this comes from a recent cross-sectional telephone survey of 15,929 individuals who were representative of the adult general population of 15 U.S. states. A total of 27.8% reported "excessive sleepiness," and 15.6% had recurrent periods of irrepressible need to sleep or to nap within the same day (13.2%); recurrent naps within the same day (1.9%); a nonrestorative (unrefreshing), prolonged main sleep episode of 9 hours or more per day (0.7%); and/or confusional arousals (sleep drunkenness) (4.4%).

Adding in the "excessive sleep" definition – frequency of at least three times per week for at least 3 months, despite normal sleep duration – dropped the hypersomnia disorder prevalence to 4.7% of the sample. Adding in "significant distress or impairment in cognitive, social, occupational, or other important areas of functioning" further dropped the prevalence to 2.6%, and the differential "hypersomnia is not better accounted for or does not occur exclusively during the course of another sleep disorder" gave a final prevalence of 1.5% (Arch. Gen. Psychiatry 2012;69:71-9).

"This is a threshold for significant daytime distress/impairment that warrants diagnosis. This kind of empirical basis is something we’ve pursued throughout DSM-5 in order to make it less dependent on expert opinion and be more data driven," Dr. Reynolds commented.

Insomnia Disorder 307.42

According to the Sleep-Wake Disorders Work Group, the following is the proposed wording of the new criteria:

A. The predominant complaint is a global sleep dissatisfaction with one or more of the following symptoms:

1. Difficulty initiating sleep (in children: without caregiver intervention).

2. Difficulty maintaining sleep (e.g., frequent or prolonged awakenings with difficulty returning to sleep) (in children: without caregiver intervention).

3. Early morning awakening (e.g., premature awakening with inability to return to sleep).

4. Nonrestorative sleep (adults).

5. Resistance to going to bed (children).

B. The sleep complaint is accompanied by significant distress or impairment in social, occupational, or other important areas of functioning as indicated by the presence of at least one of the following:

1. Fatigue or low energy.

2. Daytime sleepiness.

3. Cognitive impairments (e.g., attention, concentration, memory).

4. Mood disturbance (e.g., irritability, dysphoria).

5. Behavioral problems in children (hyperactivity, impulsivity, aggression).

6. Impaired occupational function.

7. Impaired interpersonal/social function.

8. Impaired academic function (children).

9. Negative impact on caregiver or family function (children).

C. The sleep difficulty is present for at least 3 months (empirical basis to address severity of the complaint).

D. The sleep difficulty occurs despite adequate age-appropriate circumstances and opportunity for sleep. Clinically comorbid Conditions, (may warrant individual work-up/attention):

1. Mental/psychiatric disorder (specify).

2. Medical disorder (specify).

3. Another disorder (specify).

E. The sleep difficulty occurs at least 3 nights per week.

Dr. Reynolds disclosed that he has received funding from the National Institute of Mental Health; the National Institute on Aging; the National Center on Minority Health and Health Disparities; the National Heart, Lung, and Blood Institute; the John A. Hartford Foundation; the American Foundation for Suicide Prevention; the Commonwealth of Pennsylvania; and the UPMC Endowment in Geriatric Psychiatry. Forest Laboratories, Pfizer, Lilly, and Bristol-Myers Squibb have provided pharmaceuticals for his National Institutes of Health–sponsored research.

A new position statement on managing hyperglycemia in type 2 diabetes from the American Diabetes Association and the European Association for the Study of Diabetes looks beyond glycemic control and emphasizes a patient-centered approach to care.

The updated recommendations are less prescriptive than their previous guidelines and not as algorithmic.

"This follows from the general lack of comparative-effectiveness research in this area," explained Dr. Silvio E. Inzucchi, cochair of the statement’s writing group, and his coauthors. "Our intent is therefore to encourage an appreciation of the variable and progressive nature of type 2 diabetes, the specific role of each drug, the patient and disease factors that drive clinical decision-making, and the constraints imposed by age and comorbidity."

The ADA and EASD last published a joint consensus algorithm on type 2 diabetes hyperglycemia management in 2009 (Diabetologia 2009;52:17-30).

But an update was necessary, given new information on the benefits and risks of glycemic control, the emergence of safety and efficacy data on new drug classes, restrictions on and withdrawals of existing drugs, and calls for more patient-centered care, said Dr. Inzucchi, professor of medicine and director of the Yale Diabetes Center, New Haven.

The document addresses glycemic control, but it also emphasizes the importance of managing other cardiovascular risk factors in type 2 diabetes, such as blood pressure and lipid therapy, antiplatelet treatment, and smoking cession management (Diabetes Care 2012 April 19 [doi:10.2337/dc12-0413]).

Patient participation plays a greater role in the updated recommendations. "The implementation of these guidelines will require thoughtful clinicians to integrate current evidence with other constraints and imperatives in the context of patient-specific factors," the authors said.

Patient-centered care "is respectful of and responsive to individual patient preferences, needs, and values and [ensures] that patient values guide all clinical decisions," they noted. It’s an approach that is particularly appropriate in type 2 diabetes, the authors added, because "ultimately, it is patients who make the final decisions regarding their lifestyle choices and, to some degree, the pharmaceutical interventions they use."

The guidelines recommend that providers should gauge a patient’s preferred level of involvement when making treatment decisions. "There is good evidence supporting the effectiveness of this approach," the authors noted. "Importantly, engaging patients in health care decisions may enhance adherence to therapy."

Among the statement’s other recommendations:

• Glycemic control: The glycemic control target of a hemoglobin A_1c less than 7% is unchanged from previous statements. However, more or less stringent targets may be warranted based on individual patient considerations, including patient attitude and expected treatment efforts, risks potentially associated with hypoglycemia, other adverse events, disease duration, life expectancy, important comorbidities, established vascular complications, resources, and available support systems.

• Lifestyle interventions: Lifestyle interventions aimed at increasing activity levels and optimizing food intake are "the foundation of any type 2 diabetes treatment program," the authors noted, and standardized general diabetes education – individual or group – is advised for all patients.

• Medication options: As with previous guidelines, metformin is deemed the optimal first-line drug unless there are contraindications. However, "after metformin, there are limited data to guide us," the group noted, adding that combination therapy with an additional 1-2 oral or injectable agents is "reasonable," with the aim of minimizing side effects as much as possible. Ultimately, many patients will require insulin therapy alone or in combination with other agents to maintain glucose control.

The document outlines considerations for the use of metformin in combination with agents from each of the major diabetes drug classes (sulfonylurea, thiazolidinedione, DPP-4 inhibitor, GLP-1 receptor antagonist, and insulin), as well as progression to the use of insulin alone and the various insulin-based regimens.

• Patient considerations: The statement also addresses patient considerations, including age, weight, sex/racial/ethnic/genetic differences, comorbidities, and hypoglycemia, about which there is now greater concern in patients with type 2 diabetes than in the past, due to recent trials suggesting that it may pose more danger than previously believed.

The statement concludes with a call for more high-quality comparative-effectiveness research on antihyperglycemic agents, with a sharper focus on quality of life issues and avoiding complications, as well as glycemic control. Also needed are clinical data on pharmacogenomics to determine how phenotype and patient/disease-specific characteristics should drive drug choices.

"Head-to-head comparisons of all combinations and permutations would be impossibly large," the authors admitted, so "informed judgment and the expertise of experienced clinicians will therefore always be necessary."

Dr. Inzucchi is an adviser or consultant to Boehringer Ingelheim, Merck, and Takeda. Yale University received research funding or supplies from Eli Lilly and Takeda. Dr. Inzucchi has participated in medical educational projects for which Yale University received unrestricted funding from Amylin, Boehringer Ingelheim, Eli Lilly, Merck, Novo Nordisk, and Takeda. All but one writing group member listed similar disclosures.

A new position statement on managing hyperglycemia in type 2 diabetes from the American Diabetes Association and the European Association for the Study of Diabetes looks beyond glycemic control and emphasizes a patient-centered approach to care.

The updated recommendations are less prescriptive than their previous guidelines and not as algorithmic.

"This follows from the general lack of comparative-effectiveness research in this area," explained Dr. Silvio E. Inzucchi, cochair of the statement’s writing group, and his coauthors. "Our intent is therefore to encourage an appreciation of the variable and progressive nature of type 2 diabetes, the specific role of each drug, the patient and disease factors that drive clinical decision-making, and the constraints imposed by age and comorbidity."

The ADA and EASD last published a joint consensus algorithm on type 2 diabetes hyperglycemia management in 2009 (Diabetologia 2009;52:17-30).

But an update was necessary, given new information on the benefits and risks of glycemic control, the emergence of safety and efficacy data on new drug classes, restrictions on and withdrawals of existing drugs, and calls for more patient-centered care, said Dr. Inzucchi, professor of medicine and director of the Yale Diabetes Center, New Haven.

The document addresses glycemic control, but it also emphasizes the importance of managing other cardiovascular risk factors in type 2 diabetes, such as blood pressure and lipid therapy, antiplatelet treatment, and smoking cession management (Diabetes Care 2012 April 19 [doi:10.2337/dc12-0413]).

Patient participation plays a greater role in the updated recommendations. "The implementation of these guidelines will require thoughtful clinicians to integrate current evidence with other constraints and imperatives in the context of patient-specific factors," the authors said.

Patient-centered care "is respectful of and responsive to individual patient preferences, needs, and values and [ensures] that patient values guide all clinical decisions," they noted. It’s an approach that is particularly appropriate in type 2 diabetes, the authors added, because "ultimately, it is patients who make the final decisions regarding their lifestyle choices and, to some degree, the pharmaceutical interventions they use."

The guidelines recommend that providers should gauge a patient’s preferred level of involvement when making treatment decisions. "There is good evidence supporting the effectiveness of this approach," the authors noted. "Importantly, engaging patients in health care decisions may enhance adherence to therapy."

Among the statement’s other recommendations:

• Glycemic control: The glycemic control target of a hemoglobin A_1c less than 7% is unchanged from previous statements. However, more or less stringent targets may be warranted based on individual patient considerations, including patient attitude and expected treatment efforts, risks potentially associated with hypoglycemia, other adverse events, disease duration, life expectancy, important comorbidities, established vascular complications, resources, and available support systems.

• Lifestyle interventions: Lifestyle interventions aimed at increasing activity levels and optimizing food intake are "the foundation of any type 2 diabetes treatment program," the authors noted, and standardized general diabetes education – individual or group – is advised for all patients.

• Medication options: As with previous guidelines, metformin is deemed the optimal first-line drug unless there are contraindications. However, "after metformin, there are limited data to guide us," the group noted, adding that combination therapy with an additional 1-2 oral or injectable agents is "reasonable," with the aim of minimizing side effects as much as possible. Ultimately, many patients will require insulin therapy alone or in combination with other agents to maintain glucose control.

The document outlines considerations for the use of metformin in combination with agents from each of the major diabetes drug classes (sulfonylurea, thiazolidinedione, DPP-4 inhibitor, GLP-1 receptor antagonist, and insulin), as well as progression to the use of insulin alone and the various insulin-based regimens.

• Patient considerations: The statement also addresses patient considerations, including age, weight, sex/racial/ethnic/genetic differences, comorbidities, and hypoglycemia, about which there is now greater concern in patients with type 2 diabetes than in the past, due to recent trials suggesting that it may pose more danger than previously believed.

The statement concludes with a call for more high-quality comparative-effectiveness research on antihyperglycemic agents, with a sharper focus on quality of life issues and avoiding complications, as well as glycemic control. Also needed are clinical data on pharmacogenomics to determine how phenotype and patient/disease-specific characteristics should drive drug choices.

"Head-to-head comparisons of all combinations and permutations would be impossibly large," the authors admitted, so "informed judgment and the expertise of experienced clinicians will therefore always be necessary."

Dr. Inzucchi is an adviser or consultant to Boehringer Ingelheim, Merck, and Takeda. Yale University received research funding or supplies from Eli Lilly and Takeda. Dr. Inzucchi has participated in medical educational projects for which Yale University received unrestricted funding from Amylin, Boehringer Ingelheim, Eli Lilly, Merck, Novo Nordisk, and Takeda. All but one writing group member listed similar disclosures.

A new position statement on managing hyperglycemia in type 2 diabetes from the American Diabetes Association and the European Association for the Study of Diabetes looks beyond glycemic control and emphasizes a patient-centered approach to care.

The updated recommendations are less prescriptive than their previous guidelines and not as algorithmic.

"This follows from the general lack of comparative-effectiveness research in this area," explained Dr. Silvio E. Inzucchi, cochair of the statement’s writing group, and his coauthors. "Our intent is therefore to encourage an appreciation of the variable and progressive nature of type 2 diabetes, the specific role of each drug, the patient and disease factors that drive clinical decision-making, and the constraints imposed by age and comorbidity."

The ADA and EASD last published a joint consensus algorithm on type 2 diabetes hyperglycemia management in 2009 (Diabetologia 2009;52:17-30).

But an update was necessary, given new information on the benefits and risks of glycemic control, the emergence of safety and efficacy data on new drug classes, restrictions on and withdrawals of existing drugs, and calls for more patient-centered care, said Dr. Inzucchi, professor of medicine and director of the Yale Diabetes Center, New Haven.

The document addresses glycemic control, but it also emphasizes the importance of managing other cardiovascular risk factors in type 2 diabetes, such as blood pressure and lipid therapy, antiplatelet treatment, and smoking cession management (Diabetes Care 2012 April 19 [doi:10.2337/dc12-0413]).

Patient participation plays a greater role in the updated recommendations. "The implementation of these guidelines will require thoughtful clinicians to integrate current evidence with other constraints and imperatives in the context of patient-specific factors," the authors said.

Patient-centered care "is respectful of and responsive to individual patient preferences, needs, and values and [ensures] that patient values guide all clinical decisions," they noted. It’s an approach that is particularly appropriate in type 2 diabetes, the authors added, because "ultimately, it is patients who make the final decisions regarding their lifestyle choices and, to some degree, the pharmaceutical interventions they use."

The guidelines recommend that providers should gauge a patient’s preferred level of involvement when making treatment decisions. "There is good evidence supporting the effectiveness of this approach," the authors noted. "Importantly, engaging patients in health care decisions may enhance adherence to therapy."

Among the statement’s other recommendations:

• Glycemic control: The glycemic control target of a hemoglobin A_1c less than 7% is unchanged from previous statements. However, more or less stringent targets may be warranted based on individual patient considerations, including patient attitude and expected treatment efforts, risks potentially associated with hypoglycemia, other adverse events, disease duration, life expectancy, important comorbidities, established vascular complications, resources, and available support systems.

• Lifestyle interventions: Lifestyle interventions aimed at increasing activity levels and optimizing food intake are "the foundation of any type 2 diabetes treatment program," the authors noted, and standardized general diabetes education – individual or group – is advised for all patients.

• Medication options: As with previous guidelines, metformin is deemed the optimal first-line drug unless there are contraindications. However, "after metformin, there are limited data to guide us," the group noted, adding that combination therapy with an additional 1-2 oral or injectable agents is "reasonable," with the aim of minimizing side effects as much as possible. Ultimately, many patients will require insulin therapy alone or in combination with other agents to maintain glucose control.

The document outlines considerations for the use of metformin in combination with agents from each of the major diabetes drug classes (sulfonylurea, thiazolidinedione, DPP-4 inhibitor, GLP-1 receptor antagonist, and insulin), as well as progression to the use of insulin alone and the various insulin-based regimens.

• Patient considerations: The statement also addresses patient considerations, including age, weight, sex/racial/ethnic/genetic differences, comorbidities, and hypoglycemia, about which there is now greater concern in patients with type 2 diabetes than in the past, due to recent trials suggesting that it may pose more danger than previously believed.

The statement concludes with a call for more high-quality comparative-effectiveness research on antihyperglycemic agents, with a sharper focus on quality of life issues and avoiding complications, as well as glycemic control. Also needed are clinical data on pharmacogenomics to determine how phenotype and patient/disease-specific characteristics should drive drug choices.

"Head-to-head comparisons of all combinations and permutations would be impossibly large," the authors admitted, so "informed judgment and the expertise of experienced clinicians will therefore always be necessary."

Dr. Inzucchi is an adviser or consultant to Boehringer Ingelheim, Merck, and Takeda. Yale University received research funding or supplies from Eli Lilly and Takeda. Dr. Inzucchi has participated in medical educational projects for which Yale University received unrestricted funding from Amylin, Boehringer Ingelheim, Eli Lilly, Merck, Novo Nordisk, and Takeda. All but one writing group member listed similar disclosures.

LONDON – An elevated red blood cell distribution width predicted poor outcomes from community-acquired pneumonia in a retrospective analysis of more than 3,000 adult patients.

Red blood cell distribution width (RDW) is routinely measured as a check for anemia, but there have been several previous reports that the marker predicts poor outcome in a variety of conditions, including heart failure and sepsis. "It’s used in hematology, but it proves to be an outstanding marker of adverse outcome in some very important diseases of internal medicine. ... We found it actually works in community-acquired pneumonia [CAP] as well," Dr. Eyal Braun said in an interview at the European Congress of Clinical Microbiology and Infectious Diseases.

Last year, Dr. Braun and his associates at Rambam Health Care Campus, Haifa, Israel, reported that among 637 CAP patients aged 60 years and younger, elevated RDW levels on admission were associated with significantly higher rates of mortality and severe morbidity (Crit. Care 2011;15:R194).

The current study looked at the overall general population of internal medicine wards, comprising a total of 3,815 patients aged 18 years and older seen between Jan. 1, 2005, and Dec. 31, 2010. The patients had a mean age of 69.6 years, and 56% were men.

In the multivariate analysis, factors associated with mortality at 90 days were age greater than 80 years, a high Charlson comorbidity index (above 7), a bloodstream infection (BSI), a blood urea nitrogen (BUN) level greater than 30 mg/dL, an abnormal white blood cell (WBC) count, a systolic blood pressure less than 90 mm Hg, and an elevated RDW greater than 15% (odds ratio, 2.1). Variables associated with complicated hospitalization included a high Charlson comorbidity index, an abnormal WBC count, a BUN greater than 30 mg/dL, a hemoglobin level less than 10 g/dL, a BSI on admission, and an elevated RDW (OR 1.5), Dr. Braun reported in a poster.

The rates of mortality and complicated hospitalization were significantly higher among patients with an increased RDW, regardless of the WBC count or hemoglobin levels, he and his associates found.

In the interview, Dr. Braun said that an elevated RDW might help identify which patients who present with CAP need to be admitted to the hospital. Despite many existing scores aimed at identifying increased risk among CAP patients, "people are still dying from CAP. ... The bottom line is mortality from CAP is still high."

Dr. Braun stated that he has no relevant financial disclosures.

LONDON – An elevated red blood cell distribution width predicted poor outcomes from community-acquired pneumonia in a retrospective analysis of more than 3,000 adult patients.

Red blood cell distribution width (RDW) is routinely measured as a check for anemia, but there have been several previous reports that the marker predicts poor outcome in a variety of conditions, including heart failure and sepsis. "It’s used in hematology, but it proves to be an outstanding marker of adverse outcome in some very important diseases of internal medicine. ... We found it actually works in community-acquired pneumonia [CAP] as well," Dr. Eyal Braun said in an interview at the European Congress of Clinical Microbiology and Infectious Diseases.

Last year, Dr. Braun and his associates at Rambam Health Care Campus, Haifa, Israel, reported that among 637 CAP patients aged 60 years and younger, elevated RDW levels on admission were associated with significantly higher rates of mortality and severe morbidity (Crit. Care 2011;15:R194).

The current study looked at the overall general population of internal medicine wards, comprising a total of 3,815 patients aged 18 years and older seen between Jan. 1, 2005, and Dec. 31, 2010. The patients had a mean age of 69.6 years, and 56% were men.

In the multivariate analysis, factors associated with mortality at 90 days were age greater than 80 years, a high Charlson comorbidity index (above 7), a bloodstream infection (BSI), a blood urea nitrogen (BUN) level greater than 30 mg/dL, an abnormal white blood cell (WBC) count, a systolic blood pressure less than 90 mm Hg, and an elevated RDW greater than 15% (odds ratio, 2.1). Variables associated with complicated hospitalization included a high Charlson comorbidity index, an abnormal WBC count, a BUN greater than 30 mg/dL, a hemoglobin level less than 10 g/dL, a BSI on admission, and an elevated RDW (OR 1.5), Dr. Braun reported in a poster.

The rates of mortality and complicated hospitalization were significantly higher among patients with an increased RDW, regardless of the WBC count or hemoglobin levels, he and his associates found.

In the interview, Dr. Braun said that an elevated RDW might help identify which patients who present with CAP need to be admitted to the hospital. Despite many existing scores aimed at identifying increased risk among CAP patients, "people are still dying from CAP. ... The bottom line is mortality from CAP is still high."

Dr. Braun stated that he has no relevant financial disclosures.

LONDON – An elevated red blood cell distribution width predicted poor outcomes from community-acquired pneumonia in a retrospective analysis of more than 3,000 adult patients.

Red blood cell distribution width (RDW) is routinely measured as a check for anemia, but there have been several previous reports that the marker predicts poor outcome in a variety of conditions, including heart failure and sepsis. "It’s used in hematology, but it proves to be an outstanding marker of adverse outcome in some very important diseases of internal medicine. ... We found it actually works in community-acquired pneumonia [CAP] as well," Dr. Eyal Braun said in an interview at the European Congress of Clinical Microbiology and Infectious Diseases.

Last year, Dr. Braun and his associates at Rambam Health Care Campus, Haifa, Israel, reported that among 637 CAP patients aged 60 years and younger, elevated RDW levels on admission were associated with significantly higher rates of mortality and severe morbidity (Crit. Care 2011;15:R194).

The current study looked at the overall general population of internal medicine wards, comprising a total of 3,815 patients aged 18 years and older seen between Jan. 1, 2005, and Dec. 31, 2010. The patients had a mean age of 69.6 years, and 56% were men.

In the multivariate analysis, factors associated with mortality at 90 days were age greater than 80 years, a high Charlson comorbidity index (above 7), a bloodstream infection (BSI), a blood urea nitrogen (BUN) level greater than 30 mg/dL, an abnormal white blood cell (WBC) count, a systolic blood pressure less than 90 mm Hg, and an elevated RDW greater than 15% (odds ratio, 2.1). Variables associated with complicated hospitalization included a high Charlson comorbidity index, an abnormal WBC count, a BUN greater than 30 mg/dL, a hemoglobin level less than 10 g/dL, a BSI on admission, and an elevated RDW (OR 1.5), Dr. Braun reported in a poster.

The rates of mortality and complicated hospitalization were significantly higher among patients with an increased RDW, regardless of the WBC count or hemoglobin levels, he and his associates found.

In the interview, Dr. Braun said that an elevated RDW might help identify which patients who present with CAP need to be admitted to the hospital. Despite many existing scores aimed at identifying increased risk among CAP patients, "people are still dying from CAP. ... The bottom line is mortality from CAP is still high."

Dr. Braun stated that he has no relevant financial disclosures.

WASHINGTON – Patients admitted to a freestanding psychiatric hospital with a primary diagnosis of dementia with behavioral disturbance were more likely than those without dementia to experience medical deterioration during their stay, according to a chart review study of 1,000 consecutively admitted adults.

Azotemia or anemia on admission predicted an increased risk for such decompensation among the 71 who had dementia with behavioral disturbance. "Patients with such baseline findings should receive enhanced medical evaluation, monitoring, and management to decrease preventable interruptions in care," Dr. Eugene Grudnikoff and his associates reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

Compared with the 929 nondemented patients who were admitted to the 208-bed psychiatric hospital between August and December 2010, the 71 with dementia were significantly older (78 vs. 43 years) and less likely to be male (40% vs. 54%). They were also more likely to have been transferred from another hospital (13% vs. 5%), be taking first-generation antipsychotics (27% vs. 15%), have a longer length of stay (23 vs. 19 days), and be transferred to the emergency department (42% vs. 12%).

Emergency transfer to the adjacent 480-bed medical center was used as a proxy measure for significant medical deterioration, said Dr. Grudnikoff and his associates at Zucker Hillside Hospital, Glen Oaks, N.Y., part of the North Shore–Long Island Jewish Health System.

The psychiatric patients with dementia had a significantly greater number of somatic disorders than did those without dementia, 3.8 vs. 2.8 overall. Specifically, they were more likely to have arterial hypertension (63% vs. 26%), dyslipidemia (32% vs. 19%), coronary artery disease (18% vs. 4%), heart failure (7% vs. 1%), cerebral vascular disease (13% vs. 0.5%), and hypothyroidism (17% vs. 5%). However, those without dementia were more likely to be obese (34% vs. 7% with a body mass index above 30 kg/m²).

The dementia and nondementia groups differed significantly with regard to admission laboratory data. The dementia patients had higher venous blood levels of potassium, chloride, blood urea nitrogen, and creatinine and significantly lower levels of calcium, protein, hemoglobin, and platelets. They also had higher rates of azotemia (26.5% vs. 4%), anemia (40% vs. 16%), and hypoalbuminemia (17% vs. 3%).

During their hospital stays, 30 of the dementia patients (42%) and 114 of the nondemented patients (12%) had a significant medical deterioration that required emergency transfer. Among the 30 with dementia, reasons for transfer included fever in eight patients (27%); falls in another eight (27%); hypoxia in three (10%); hypotension, chest pain, and deep vein thrombosis in two patients each (7%); and stroke, delirium, vomiting, rectal bleeding, and edema in one patient each (3%).

Within the dementia group, the positive predictive values for emergency transfer were 61% for azotemia and 61.5% for anemia, but just 30% for hypoalbuminemia. After evaluation and treatment during a stay in the emergency department of up to 23 hours, patients with dementia were more likely to be admitted to a medical unit of the general hospital (17% vs. 6.5%), Dr. Grudnikoff and his associates reported.

Dr. Grudnikoff stated that he has nothing to disclose. Two of the six study coauthors declared financial relationships with several pharmaceutical companies.

WASHINGTON – Patients admitted to a freestanding psychiatric hospital with a primary diagnosis of dementia with behavioral disturbance were more likely than those without dementia to experience medical deterioration during their stay, according to a chart review study of 1,000 consecutively admitted adults.

Azotemia or anemia on admission predicted an increased risk for such decompensation among the 71 who had dementia with behavioral disturbance. "Patients with such baseline findings should receive enhanced medical evaluation, monitoring, and management to decrease preventable interruptions in care," Dr. Eugene Grudnikoff and his associates reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

Compared with the 929 nondemented patients who were admitted to the 208-bed psychiatric hospital between August and December 2010, the 71 with dementia were significantly older (78 vs. 43 years) and less likely to be male (40% vs. 54%). They were also more likely to have been transferred from another hospital (13% vs. 5%), be taking first-generation antipsychotics (27% vs. 15%), have a longer length of stay (23 vs. 19 days), and be transferred to the emergency department (42% vs. 12%).

Emergency transfer to the adjacent 480-bed medical center was used as a proxy measure for significant medical deterioration, said Dr. Grudnikoff and his associates at Zucker Hillside Hospital, Glen Oaks, N.Y., part of the North Shore–Long Island Jewish Health System.

The psychiatric patients with dementia had a significantly greater number of somatic disorders than did those without dementia, 3.8 vs. 2.8 overall. Specifically, they were more likely to have arterial hypertension (63% vs. 26%), dyslipidemia (32% vs. 19%), coronary artery disease (18% vs. 4%), heart failure (7% vs. 1%), cerebral vascular disease (13% vs. 0.5%), and hypothyroidism (17% vs. 5%). However, those without dementia were more likely to be obese (34% vs. 7% with a body mass index above 30 kg/m²).

The dementia and nondementia groups differed significantly with regard to admission laboratory data. The dementia patients had higher venous blood levels of potassium, chloride, blood urea nitrogen, and creatinine and significantly lower levels of calcium, protein, hemoglobin, and platelets. They also had higher rates of azotemia (26.5% vs. 4%), anemia (40% vs. 16%), and hypoalbuminemia (17% vs. 3%).

During their hospital stays, 30 of the dementia patients (42%) and 114 of the nondemented patients (12%) had a significant medical deterioration that required emergency transfer. Among the 30 with dementia, reasons for transfer included fever in eight patients (27%); falls in another eight (27%); hypoxia in three (10%); hypotension, chest pain, and deep vein thrombosis in two patients each (7%); and stroke, delirium, vomiting, rectal bleeding, and edema in one patient each (3%).

Within the dementia group, the positive predictive values for emergency transfer were 61% for azotemia and 61.5% for anemia, but just 30% for hypoalbuminemia. After evaluation and treatment during a stay in the emergency department of up to 23 hours, patients with dementia were more likely to be admitted to a medical unit of the general hospital (17% vs. 6.5%), Dr. Grudnikoff and his associates reported.

Dr. Grudnikoff stated that he has nothing to disclose. Two of the six study coauthors declared financial relationships with several pharmaceutical companies.

WASHINGTON – Patients admitted to a freestanding psychiatric hospital with a primary diagnosis of dementia with behavioral disturbance were more likely than those without dementia to experience medical deterioration during their stay, according to a chart review study of 1,000 consecutively admitted adults.

Azotemia or anemia on admission predicted an increased risk for such decompensation among the 71 who had dementia with behavioral disturbance. "Patients with such baseline findings should receive enhanced medical evaluation, monitoring, and management to decrease preventable interruptions in care," Dr. Eugene Grudnikoff and his associates reported in a poster at the annual meeting of the American Association for Geriatric Psychiatry.

Compared with the 929 nondemented patients who were admitted to the 208-bed psychiatric hospital between August and December 2010, the 71 with dementia were significantly older (78 vs. 43 years) and less likely to be male (40% vs. 54%). They were also more likely to have been transferred from another hospital (13% vs. 5%), be taking first-generation antipsychotics (27% vs. 15%), have a longer length of stay (23 vs. 19 days), and be transferred to the emergency department (42% vs. 12%).

Emergency transfer to the adjacent 480-bed medical center was used as a proxy measure for significant medical deterioration, said Dr. Grudnikoff and his associates at Zucker Hillside Hospital, Glen Oaks, N.Y., part of the North Shore–Long Island Jewish Health System.

The psychiatric patients with dementia had a significantly greater number of somatic disorders than did those without dementia, 3.8 vs. 2.8 overall. Specifically, they were more likely to have arterial hypertension (63% vs. 26%), dyslipidemia (32% vs. 19%), coronary artery disease (18% vs. 4%), heart failure (7% vs. 1%), cerebral vascular disease (13% vs. 0.5%), and hypothyroidism (17% vs. 5%). However, those without dementia were more likely to be obese (34% vs. 7% with a body mass index above 30 kg/m²).

The dementia and nondementia groups differed significantly with regard to admission laboratory data. The dementia patients had higher venous blood levels of potassium, chloride, blood urea nitrogen, and creatinine and significantly lower levels of calcium, protein, hemoglobin, and platelets. They also had higher rates of azotemia (26.5% vs. 4%), anemia (40% vs. 16%), and hypoalbuminemia (17% vs. 3%).

During their hospital stays, 30 of the dementia patients (42%) and 114 of the nondemented patients (12%) had a significant medical deterioration that required emergency transfer. Among the 30 with dementia, reasons for transfer included fever in eight patients (27%); falls in another eight (27%); hypoxia in three (10%); hypotension, chest pain, and deep vein thrombosis in two patients each (7%); and stroke, delirium, vomiting, rectal bleeding, and edema in one patient each (3%).

Within the dementia group, the positive predictive values for emergency transfer were 61% for azotemia and 61.5% for anemia, but just 30% for hypoalbuminemia. After evaluation and treatment during a stay in the emergency department of up to 23 hours, patients with dementia were more likely to be admitted to a medical unit of the general hospital (17% vs. 6.5%), Dr. Grudnikoff and his associates reported.

Dr. Grudnikoff stated that he has nothing to disclose. Two of the six study coauthors declared financial relationships with several pharmaceutical companies.