Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.

CVD Risk Factors Greater in Girls With Type 1 Diabetes

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Major Finding: Compared with boys who have type 1 diabetes, girls with the disease had significantly increased average hemoglobin A1c levels (9.1% vs. 8.7%, respectively); body mass index z score (0.72 vs. 0.49); low-density lipoprotein cholesterol (95 mg/dL vs. 82 mg/dL); and C-reactive protein (0.86 mg/dL vs. 0.15 mg/dL).

Data Source: A study of gender differences and cardiovascular disease risk factors among 302 adolescents with type 1 diabetes and 100 adolescents without the disease.

Disclosures: The study was funded by the Juvenile Diabetes Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, and Children's Hospital Colorado Clinical Translational Research Center. Ms. Brown said she had no relevant financial disclosures.

SAN DIEGO – Girls with type 1 diabetes had significantly increased mean hemoglobin A1c levels, body mass index, low-density lipoprotein cholesterol, and C-reactive protein, compared with boys who have the disease, results from a single-center study of 402 adolescents demonstrated.

The finding suggests that adolescence “may be a critical period for CVD prevention in girls with type 1 diabetes,” Talia L. Brown said at the meeting. “Future studies should investigate factors contributing to these gender differences.”

Adults with type 1 diabetes are known to have a higher risk of cardiovascular disease compared with nondiabetic adults, said Ms. Brown, a graduate student who is a research assistant at the Barbara Davis Center for Childhood Diabetes, Aurora, Colo.

“There is a greater relative increase in women, where women with type 1 diabetes have four times the CVD risk as nondiabetic women,” Ms. Brown said. “Meanwhile, men with type 1 diabetes have two times greater CVD risk than nondiabetic men. It is uncertain when these gender differences begin.”

To find out, she and her associates compared the cardiovascular disease risk profile of 302 adolescents with type 1 diabetes with 100 nondiabetic adolescents and evaluated gender differences between the groups. The adolescents' mean age was 15 years.

Tanner stage was assessed by a physician or self-report at the visit.

Measures included fasting lipids, assays for HbA1c and C-reactive protein, diastolic and systolic blood pressure, and body mass index z score.

The researchers used questionnaires to assess physical activity and average insulin dose, and they used multivariate linear regression to examine each cardiovascular disease risk factor.

Ms. Brown reported that physical activity was equivalent among the study participants (a mean of about 2 hr/day), and insulin dose was similar between boys and girls (a mean of 1.1 vs. 1.2 U/kg).

Compared with boys with type 1 diabetes, girls with the disease had significantly increased mean hemoglobin A1c (9.1% vs. 8.7%, respectively), body mass index z score (0.72 vs. 0.49), LDL cholesterol (95 mg/dL vs. 82 mg/dL), and C-reactive protein (0.86 mg/dL vs. 0.15 mg/dL).

Boys with type 1 diabetes had higher levels of systolic blood pressure, compared with girls with the disease – 115 mm Hg vs. 111 mm Hg. But girls with type 1 diabetes had higher levels of systolic blood pressure, compared with nondiabetic girls (111 mm Hg vs. 106 mm Hg).

“Girls with diabetes had higher LDL levels than both boys with type 1 diabetes and girls without diabetes,” Ms. Brown added. “[C-reactive protein] was ninefold higher in girls with type 1 diabetes than in both girls without diabetes and boys with type 1 diabetes.”

After adjustment for hemoglobin A1c level and BMI z score, a significant increase in C-reactive protein and LDL in girls with type 1 diabetes remained, the study results showed.

The researchers also found a significant interaction between gender and diabetes, “causing type 1 diabetes to have a more detrimental effect in girls than in boys with regard to LDL cholesterol and systolic blood pressure,” Ms. Brown said.

Increased HbA1c level and body mass index “are likely to contribute to the increased blood pressure, inflammation, and cholesterol that we observed in girls with type 1 diabetes,” she said.

“These findings are somewhat unexpected, because generally there can be an inverse relationship between glycemic control and weight. Increased HbA1c and obesity are likely to translate into worse CVD outcomes for females, and raise concern for the long-term effects in CVD health.”

When asked to speculate why HbA1c and body mass index were increased in girls with type 1, Ms. Brown said that girls generally “have a hard time controlling both [factors], so it's hard to know what's contributing to this.”

Prevention efforts such as maintaining a healthy diet, getting adequate physical exercise, and controlling blood pressure and cholesterol levels “may improve this problem,” she said.

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Major Finding: Compared with boys who have type 1 diabetes, girls with the disease had significantly increased average hemoglobin A1c levels (9.1% vs. 8.7%, respectively); body mass index z score (0.72 vs. 0.49); low-density lipoprotein cholesterol (95 mg/dL vs. 82 mg/dL); and C-reactive protein (0.86 mg/dL vs. 0.15 mg/dL).

Data Source: A study of gender differences and cardiovascular disease risk factors among 302 adolescents with type 1 diabetes and 100 adolescents without the disease.

Disclosures: The study was funded by the Juvenile Diabetes Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, and Children's Hospital Colorado Clinical Translational Research Center. Ms. Brown said she had no relevant financial disclosures.

SAN DIEGO – Girls with type 1 diabetes had significantly increased mean hemoglobin A1c levels, body mass index, low-density lipoprotein cholesterol, and C-reactive protein, compared with boys who have the disease, results from a single-center study of 402 adolescents demonstrated.

The finding suggests that adolescence “may be a critical period for CVD prevention in girls with type 1 diabetes,” Talia L. Brown said at the meeting. “Future studies should investigate factors contributing to these gender differences.”

Adults with type 1 diabetes are known to have a higher risk of cardiovascular disease compared with nondiabetic adults, said Ms. Brown, a graduate student who is a research assistant at the Barbara Davis Center for Childhood Diabetes, Aurora, Colo.

“There is a greater relative increase in women, where women with type 1 diabetes have four times the CVD risk as nondiabetic women,” Ms. Brown said. “Meanwhile, men with type 1 diabetes have two times greater CVD risk than nondiabetic men. It is uncertain when these gender differences begin.”

To find out, she and her associates compared the cardiovascular disease risk profile of 302 adolescents with type 1 diabetes with 100 nondiabetic adolescents and evaluated gender differences between the groups. The adolescents' mean age was 15 years.

Tanner stage was assessed by a physician or self-report at the visit.

Measures included fasting lipids, assays for HbA1c and C-reactive protein, diastolic and systolic blood pressure, and body mass index z score.

The researchers used questionnaires to assess physical activity and average insulin dose, and they used multivariate linear regression to examine each cardiovascular disease risk factor.

Ms. Brown reported that physical activity was equivalent among the study participants (a mean of about 2 hr/day), and insulin dose was similar between boys and girls (a mean of 1.1 vs. 1.2 U/kg).

Compared with boys with type 1 diabetes, girls with the disease had significantly increased mean hemoglobin A1c (9.1% vs. 8.7%, respectively), body mass index z score (0.72 vs. 0.49), LDL cholesterol (95 mg/dL vs. 82 mg/dL), and C-reactive protein (0.86 mg/dL vs. 0.15 mg/dL).

Boys with type 1 diabetes had higher levels of systolic blood pressure, compared with girls with the disease – 115 mm Hg vs. 111 mm Hg. But girls with type 1 diabetes had higher levels of systolic blood pressure, compared with nondiabetic girls (111 mm Hg vs. 106 mm Hg).

“Girls with diabetes had higher LDL levels than both boys with type 1 diabetes and girls without diabetes,” Ms. Brown added. “[C-reactive protein] was ninefold higher in girls with type 1 diabetes than in both girls without diabetes and boys with type 1 diabetes.”

After adjustment for hemoglobin A1c level and BMI z score, a significant increase in C-reactive protein and LDL in girls with type 1 diabetes remained, the study results showed.

The researchers also found a significant interaction between gender and diabetes, “causing type 1 diabetes to have a more detrimental effect in girls than in boys with regard to LDL cholesterol and systolic blood pressure,” Ms. Brown said.

Increased HbA1c level and body mass index “are likely to contribute to the increased blood pressure, inflammation, and cholesterol that we observed in girls with type 1 diabetes,” she said.

“These findings are somewhat unexpected, because generally there can be an inverse relationship between glycemic control and weight. Increased HbA1c and obesity are likely to translate into worse CVD outcomes for females, and raise concern for the long-term effects in CVD health.”

When asked to speculate why HbA1c and body mass index were increased in girls with type 1, Ms. Brown said that girls generally “have a hard time controlling both [factors], so it's hard to know what's contributing to this.”

Prevention efforts such as maintaining a healthy diet, getting adequate physical exercise, and controlling blood pressure and cholesterol levels “may improve this problem,” she said.

Major Finding: Compared with boys who have type 1 diabetes, girls with the disease had significantly increased average hemoglobin A1c levels (9.1% vs. 8.7%, respectively); body mass index z score (0.72 vs. 0.49); low-density lipoprotein cholesterol (95 mg/dL vs. 82 mg/dL); and C-reactive protein (0.86 mg/dL vs. 0.15 mg/dL).

Data Source: A study of gender differences and cardiovascular disease risk factors among 302 adolescents with type 1 diabetes and 100 adolescents without the disease.

Disclosures: The study was funded by the Juvenile Diabetes Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, and Children's Hospital Colorado Clinical Translational Research Center. Ms. Brown said she had no relevant financial disclosures.

SAN DIEGO – Girls with type 1 diabetes had significantly increased mean hemoglobin A1c levels, body mass index, low-density lipoprotein cholesterol, and C-reactive protein, compared with boys who have the disease, results from a single-center study of 402 adolescents demonstrated.

The finding suggests that adolescence “may be a critical period for CVD prevention in girls with type 1 diabetes,” Talia L. Brown said at the meeting. “Future studies should investigate factors contributing to these gender differences.”

Adults with type 1 diabetes are known to have a higher risk of cardiovascular disease compared with nondiabetic adults, said Ms. Brown, a graduate student who is a research assistant at the Barbara Davis Center for Childhood Diabetes, Aurora, Colo.

“There is a greater relative increase in women, where women with type 1 diabetes have four times the CVD risk as nondiabetic women,” Ms. Brown said. “Meanwhile, men with type 1 diabetes have two times greater CVD risk than nondiabetic men. It is uncertain when these gender differences begin.”

To find out, she and her associates compared the cardiovascular disease risk profile of 302 adolescents with type 1 diabetes with 100 nondiabetic adolescents and evaluated gender differences between the groups. The adolescents' mean age was 15 years.

Tanner stage was assessed by a physician or self-report at the visit.

Measures included fasting lipids, assays for HbA1c and C-reactive protein, diastolic and systolic blood pressure, and body mass index z score.

The researchers used questionnaires to assess physical activity and average insulin dose, and they used multivariate linear regression to examine each cardiovascular disease risk factor.

Ms. Brown reported that physical activity was equivalent among the study participants (a mean of about 2 hr/day), and insulin dose was similar between boys and girls (a mean of 1.1 vs. 1.2 U/kg).

Compared with boys with type 1 diabetes, girls with the disease had significantly increased mean hemoglobin A1c (9.1% vs. 8.7%, respectively), body mass index z score (0.72 vs. 0.49), LDL cholesterol (95 mg/dL vs. 82 mg/dL), and C-reactive protein (0.86 mg/dL vs. 0.15 mg/dL).

Boys with type 1 diabetes had higher levels of systolic blood pressure, compared with girls with the disease – 115 mm Hg vs. 111 mm Hg. But girls with type 1 diabetes had higher levels of systolic blood pressure, compared with nondiabetic girls (111 mm Hg vs. 106 mm Hg).

“Girls with diabetes had higher LDL levels than both boys with type 1 diabetes and girls without diabetes,” Ms. Brown added. “[C-reactive protein] was ninefold higher in girls with type 1 diabetes than in both girls without diabetes and boys with type 1 diabetes.”

After adjustment for hemoglobin A1c level and BMI z score, a significant increase in C-reactive protein and LDL in girls with type 1 diabetes remained, the study results showed.

The researchers also found a significant interaction between gender and diabetes, “causing type 1 diabetes to have a more detrimental effect in girls than in boys with regard to LDL cholesterol and systolic blood pressure,” Ms. Brown said.

Increased HbA1c level and body mass index “are likely to contribute to the increased blood pressure, inflammation, and cholesterol that we observed in girls with type 1 diabetes,” she said.

“These findings are somewhat unexpected, because generally there can be an inverse relationship between glycemic control and weight. Increased HbA1c and obesity are likely to translate into worse CVD outcomes for females, and raise concern for the long-term effects in CVD health.”

When asked to speculate why HbA1c and body mass index were increased in girls with type 1, Ms. Brown said that girls generally “have a hard time controlling both [factors], so it's hard to know what's contributing to this.”

Prevention efforts such as maintaining a healthy diet, getting adequate physical exercise, and controlling blood pressure and cholesterol levels “may improve this problem,” she said.

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Depression Ups Mortality Risk in Type 2 Diabetes

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Major Finding: Among adults with type 2 diabetes, total mortality was significantly increased both in those with a PHQ-9 score of 10 or more (HR, 1.84) and major depression (HR, 2.24), but not in those with minor depression (HR, 1.14).

Data Source: An analysis of 2,053 participants in the ACCORD Health-Related Quality of Life investigation who completed the nine-item depression measure from the PHQ-9 at baseline and at 12, 36, and 48 months.

Disclosures: Dr. O'Connor had no relevant conflicts of interest.

SAN DIEGO – Depression is a significant independent predictor of increased mortality and may increase the risk of subsequent macrovascular events in adults with type 2 diabetes, according to a data analysis.

The findings underscore the importance of detecting and effectively managing depression in people with type 2 diabetes, said Dr. Patrick J. O'Connor, a senior clinical investigator at HealthPartners Research Foundation, Minneapolis.

The findings were based on an analysis of 2,053 participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study's HRQL (Health-Related Quality of Life) investigation, all of whom completed the 9-item depression measure from the Patient Health Questionnaire (PHQ-9) at baseline and at 12, 36, and 48 months.

“The PHQ-9 exam is not a face-to-face mental health exam with a psychiatrist; it is nine questions on a piece of paper, so it's good but it's not perfect,” Dr. O'Connor said at the meeting.

A score of 10 or more on the PHQ-9 has a sensitivity of 77% and a specificity of 94% for the diagnosis of major depression.

The researchers measured depression in three different ways: having a PHQ-9 score of 10 or greater (indicating moderate to major depression); scoring 2-3 points on five of the items (considered major depression), and scoring 2 or more points on three or four of the items (considered minor depression).

Cox proportional hazard regression modeling was used to estimate hazard ratios for the impact of depression status on ACCORD's clinical end points: the primary composite outcome (cardiovascular death, or nonfatal myocardial infarction or stroke), the macrovascular composite outcome (CV death, nonfatal MI or stroke, or heart failure), and the microvascular composite outcome (progression of retinopathy, nephropathy, and neuropathy).

The mean age of study participants was 62 years, and 39% were women. Of the 2,053 patients, 712 (35%) reported a history of depression at baseline. Compared with those who reported no history of depression, those who did were more likely to be women (46% vs. 36%, respectively), to be smokers (17% vs. 11%), to have a higher mean hemoglobin A1c level (8.4% vs. 8.2%), and to require insulin (41% vs. 33%).

About a third of the study participants scored 10 or more on the PHQ-9, which indicated moderate to major depression; 15% were considered to have major depression and 18% minor depression.

After adjustment for numerous factors (including age, sex, race, cardiovascular status, HbA1c levels, lipid levels, blood pressure, body mass index, and smoking status), total mortality was significantly increased both in those with a PHQ-9 score of 10 or more (hazard ratio, 1.84), and major depression (HR, 2.24), but not in those with minor depression (HR, 1.14).

“This shows that depression status is an independent predictor of mortality, even after you adjust for cardiovascular risk factors,” Dr. O'Connor commented.

The relationship of major depression to ACCORD's macrovascular outcome reached borderline statistical significance (HR, 1.42), but major depression was not significantly related to ACCORD's primary composite outcome (HR, 1.53) or to ACCORD's microvascular composite outcome (HR, 0.93).

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Major Finding: Among adults with type 2 diabetes, total mortality was significantly increased both in those with a PHQ-9 score of 10 or more (HR, 1.84) and major depression (HR, 2.24), but not in those with minor depression (HR, 1.14).

Data Source: An analysis of 2,053 participants in the ACCORD Health-Related Quality of Life investigation who completed the nine-item depression measure from the PHQ-9 at baseline and at 12, 36, and 48 months.

Disclosures: Dr. O'Connor had no relevant conflicts of interest.

SAN DIEGO – Depression is a significant independent predictor of increased mortality and may increase the risk of subsequent macrovascular events in adults with type 2 diabetes, according to a data analysis.

The findings underscore the importance of detecting and effectively managing depression in people with type 2 diabetes, said Dr. Patrick J. O'Connor, a senior clinical investigator at HealthPartners Research Foundation, Minneapolis.

The findings were based on an analysis of 2,053 participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study's HRQL (Health-Related Quality of Life) investigation, all of whom completed the 9-item depression measure from the Patient Health Questionnaire (PHQ-9) at baseline and at 12, 36, and 48 months.

“The PHQ-9 exam is not a face-to-face mental health exam with a psychiatrist; it is nine questions on a piece of paper, so it's good but it's not perfect,” Dr. O'Connor said at the meeting.

A score of 10 or more on the PHQ-9 has a sensitivity of 77% and a specificity of 94% for the diagnosis of major depression.

The researchers measured depression in three different ways: having a PHQ-9 score of 10 or greater (indicating moderate to major depression); scoring 2-3 points on five of the items (considered major depression), and scoring 2 or more points on three or four of the items (considered minor depression).

Cox proportional hazard regression modeling was used to estimate hazard ratios for the impact of depression status on ACCORD's clinical end points: the primary composite outcome (cardiovascular death, or nonfatal myocardial infarction or stroke), the macrovascular composite outcome (CV death, nonfatal MI or stroke, or heart failure), and the microvascular composite outcome (progression of retinopathy, nephropathy, and neuropathy).

The mean age of study participants was 62 years, and 39% were women. Of the 2,053 patients, 712 (35%) reported a history of depression at baseline. Compared with those who reported no history of depression, those who did were more likely to be women (46% vs. 36%, respectively), to be smokers (17% vs. 11%), to have a higher mean hemoglobin A1c level (8.4% vs. 8.2%), and to require insulin (41% vs. 33%).

About a third of the study participants scored 10 or more on the PHQ-9, which indicated moderate to major depression; 15% were considered to have major depression and 18% minor depression.

After adjustment for numerous factors (including age, sex, race, cardiovascular status, HbA1c levels, lipid levels, blood pressure, body mass index, and smoking status), total mortality was significantly increased both in those with a PHQ-9 score of 10 or more (hazard ratio, 1.84), and major depression (HR, 2.24), but not in those with minor depression (HR, 1.14).

“This shows that depression status is an independent predictor of mortality, even after you adjust for cardiovascular risk factors,” Dr. O'Connor commented.

The relationship of major depression to ACCORD's macrovascular outcome reached borderline statistical significance (HR, 1.42), but major depression was not significantly related to ACCORD's primary composite outcome (HR, 1.53) or to ACCORD's microvascular composite outcome (HR, 0.93).

Major Finding: Among adults with type 2 diabetes, total mortality was significantly increased both in those with a PHQ-9 score of 10 or more (HR, 1.84) and major depression (HR, 2.24), but not in those with minor depression (HR, 1.14).

Data Source: An analysis of 2,053 participants in the ACCORD Health-Related Quality of Life investigation who completed the nine-item depression measure from the PHQ-9 at baseline and at 12, 36, and 48 months.

Disclosures: Dr. O'Connor had no relevant conflicts of interest.

SAN DIEGO – Depression is a significant independent predictor of increased mortality and may increase the risk of subsequent macrovascular events in adults with type 2 diabetes, according to a data analysis.

The findings underscore the importance of detecting and effectively managing depression in people with type 2 diabetes, said Dr. Patrick J. O'Connor, a senior clinical investigator at HealthPartners Research Foundation, Minneapolis.

The findings were based on an analysis of 2,053 participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study's HRQL (Health-Related Quality of Life) investigation, all of whom completed the 9-item depression measure from the Patient Health Questionnaire (PHQ-9) at baseline and at 12, 36, and 48 months.

“The PHQ-9 exam is not a face-to-face mental health exam with a psychiatrist; it is nine questions on a piece of paper, so it's good but it's not perfect,” Dr. O'Connor said at the meeting.

A score of 10 or more on the PHQ-9 has a sensitivity of 77% and a specificity of 94% for the diagnosis of major depression.

The researchers measured depression in three different ways: having a PHQ-9 score of 10 or greater (indicating moderate to major depression); scoring 2-3 points on five of the items (considered major depression), and scoring 2 or more points on three or four of the items (considered minor depression).

Cox proportional hazard regression modeling was used to estimate hazard ratios for the impact of depression status on ACCORD's clinical end points: the primary composite outcome (cardiovascular death, or nonfatal myocardial infarction or stroke), the macrovascular composite outcome (CV death, nonfatal MI or stroke, or heart failure), and the microvascular composite outcome (progression of retinopathy, nephropathy, and neuropathy).

The mean age of study participants was 62 years, and 39% were women. Of the 2,053 patients, 712 (35%) reported a history of depression at baseline. Compared with those who reported no history of depression, those who did were more likely to be women (46% vs. 36%, respectively), to be smokers (17% vs. 11%), to have a higher mean hemoglobin A1c level (8.4% vs. 8.2%), and to require insulin (41% vs. 33%).

About a third of the study participants scored 10 or more on the PHQ-9, which indicated moderate to major depression; 15% were considered to have major depression and 18% minor depression.

After adjustment for numerous factors (including age, sex, race, cardiovascular status, HbA1c levels, lipid levels, blood pressure, body mass index, and smoking status), total mortality was significantly increased both in those with a PHQ-9 score of 10 or more (hazard ratio, 1.84), and major depression (HR, 2.24), but not in those with minor depression (HR, 1.14).

“This shows that depression status is an independent predictor of mortality, even after you adjust for cardiovascular risk factors,” Dr. O'Connor commented.

The relationship of major depression to ACCORD's macrovascular outcome reached borderline statistical significance (HR, 1.42), but major depression was not significantly related to ACCORD's primary composite outcome (HR, 1.53) or to ACCORD's microvascular composite outcome (HR, 0.93).

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Mental-Health Screening of Teens at School Gets Results

Creating Effective Delivery Systems Is Critical
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Systematic, voluntary mental health screening of high school students can help identify those who are at risk for serious mental health problems, and can connect them with much-needed care, a study of almost 2,500 adolescents suggests.

In addition, students who are referred for school-based mental health services are generally less severely ill than their counterparts who are referred for community-based services, with lower rates of self-reported suicidal ideation, depression, and substance abuse as well as lower interviewer-assessed rates of prior suicide attempts and self-injury.

The findings, reported in the September 2011 issue of the Journal of the American Academy of Child and Adolescent Psychiatry, come from a study that set out to identify the extent to which at-risk youth are identified and connected with appropriate mental health services.

"Research on post-screening access to care has been hindered by a paucity of information concerning follow-up with students referred to services," wrote the researchers, led by Mathilde M. Husky, Ph.D., of the New York State Psychiatric Institute at Columbia University. "When information is available, it is often limited to the first outpatient visit. As a result, it is not known what proportion of referred youth drop out early from follow-up care."

During 2005-2009, some 4,509 ninth graders at six public high schools in suburban Wisconsin were offered systematic voluntary mental health screening. Students completed a computerized self-report assessment known as the DPS-8 (Diagnostic Predictive Scales–8, an abbreviated form of the Diagnostic Interview Schedule for Children–IV). Students were deemed to be "at risk" if they screened positive or were identified by screening staff as being in need of further assessment (J. Am. Acad. Child Adolesc. Psychiatry 2011;50:881-91).

After the screening, each student was seen for a one-on-one debriefing to discuss the results. Students who screened positive on the self-report or who asked for help during the debriefing stayed for a second-stage clinical interview. After that, the interviewer offered referral to school-based services, community-based services, neither, or both.

Of the 4,509 students, 2,488 (56%) provided both parent consent and youth assent, and were included in the final analysis. Of the 2,488 students, 489 (20%) were identified as being at risk. Of these, 74% were not receiving any mental health services.

Overall, 74% of students were referred to school-based services, whereas 53% were referred to community-based services. In addition, 76% of referred students received at least one follow-up visit and 56% received minimally adequate treatment, which was defined as "having three or more visits with a given provider, or any number of visits if termination occurred in accordance with the provider’s recommendation."

Compared with students who were referred to school-based services, those who were referred to community-based services self-reported higher rates of suicidal ideation (26% vs. 11%, respectively), depression (50% vs. 41%), and substance abuse (17% vs. 9%). They also had higher rates of certain interviewer-assessed variables, including passive suicidal ideation (51% vs. 31%), active suicidal ideation (21% vs. 4%), prior suicide attempt (17% vs. 6%), and self-injury (33% vs. 14%). The researchers said that these findings are consistent with a 2005 report from the Substance Abuse and Mental Health Services Administration, "suggesting that youth with more serious problems are more commonly referred to community providers."

Among adolescents who received a referral to school-based services, 80% received at least one visit, compared with only 42% of those who received a referral to community-based services. "Referral decisions may be driven by specific symptoms, current distress, student or family preferences, past treatment experiences, provider availability, [and] logistical and economic considerations, as well as a host of other factors that were not measured in this study," Dr. Husky and her associates stated. "Although schools remain important providers of mental health services, our findings suggest that the implementation of proactive efforts to link youth with serious conditions to services may best be achieved when both school and community mental health providers are available."

Dr. David Fassler

In an interview, Dr. David Fassler, professor of psychiatry at the University of Vermont, Burlington, characterized the study’s findings as generally consistent with those of previous reports. "Signs of psychiatric disorders, including suicidal ideation, are not uncommon in adolescents," he said. "Yet most young people with significant symptoms receive little, if any, treatment. Schools are a logical place to try and identify students who may need help, and to facilitate referrals, as appropriate. However, as this study demonstrates, accessing follow-up care often remains a challenge, particularly when services are located outside the school setting."

Dr. Fassler went on to note that the study’s findings "will be useful in the development of programs and policies designed to identify at-risk students. They will also help inform future research on school-based screening initiatives."

 

 

The researchers acknowledged certain limitations of their study, including the lack of a control group and the potential for selection bias. "It is likely that parent refusal, related to stigma and other societal factors, diminished the rate of student participation," they wrote. "Furthermore, beyond the limitation that the modest participation rate poses to the generalizability of the sample, it also points to the constraints of the intervention as a substantial portion of adolescents does not have access to its potential benefits."

The researchers had no relevant financial conflicts to disclose.

Body

Adolescence is a time of increased risk for many serious mental health problems, including suicide and substance abuse. The Wisconsin school-based screening initiative evaluated in this study is an important effort to identify adolescents who are at risk and to link them with appropriate services in the school or in the community.

This study, although limited because of its retrospective case design, provides some important information about the pervasiveness of the problem and some clues about the factors that may impede access to care.


Dr. Kayla Pope

It is alarming that only 42% of the adolescents referred for community-based care and 80% of the children referred for school-based treatment had one contact with a treatment provider. The percentages were even lower for both groups who received minimally adequate treatment (defined as three or more visits). Although there is no information on outcomes for the children who were identified as being at risk, the "adequacy" of treatment remains a significant question. It is also interesting to note that adolescents referred for community-based care, despite some evidence of higher acuity (rates of suicide and self-injurious behavior), were even less likely to access services.

The identification of adolescents at risk is an important first step, but the creation of delivery systems that ensure appropriate treatment is also critical. While school-based care is one model, an innovative alternative called Headspace (http://www.headspace.org.au) has been developed by a group in Australia. The program is designed to provide services to adolescents where they spend their time, namely on the Internet and in the community. The online component provides information about mental health problems, self assessments, and access to mental health professionals. Teens are then linked to community centers that provide mental health assessments and treatment in addition to providing other basic medical services.

Whether school-based or community-based, we need to do a better job providing for the mental health needs of this population.

Kayla Pope, M.D., J.D., is a clinical research fellow at the National Institute of Mental Health. She had no relevant financial conflicts to disclose.

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mental health screening, high school students, identify at risk, serious mental health problems, referred for school-based mental health services, community-based services, suicidal ideation, depression, substance abuse, the Journal of the American Academy of Child and Adolescent Psychiatry, Mathilde M. Husky, Ph.D., DPS-8,
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Body

Adolescence is a time of increased risk for many serious mental health problems, including suicide and substance abuse. The Wisconsin school-based screening initiative evaluated in this study is an important effort to identify adolescents who are at risk and to link them with appropriate services in the school or in the community.

This study, although limited because of its retrospective case design, provides some important information about the pervasiveness of the problem and some clues about the factors that may impede access to care.


Dr. Kayla Pope

It is alarming that only 42% of the adolescents referred for community-based care and 80% of the children referred for school-based treatment had one contact with a treatment provider. The percentages were even lower for both groups who received minimally adequate treatment (defined as three or more visits). Although there is no information on outcomes for the children who were identified as being at risk, the "adequacy" of treatment remains a significant question. It is also interesting to note that adolescents referred for community-based care, despite some evidence of higher acuity (rates of suicide and self-injurious behavior), were even less likely to access services.

The identification of adolescents at risk is an important first step, but the creation of delivery systems that ensure appropriate treatment is also critical. While school-based care is one model, an innovative alternative called Headspace (http://www.headspace.org.au) has been developed by a group in Australia. The program is designed to provide services to adolescents where they spend their time, namely on the Internet and in the community. The online component provides information about mental health problems, self assessments, and access to mental health professionals. Teens are then linked to community centers that provide mental health assessments and treatment in addition to providing other basic medical services.

Whether school-based or community-based, we need to do a better job providing for the mental health needs of this population.

Kayla Pope, M.D., J.D., is a clinical research fellow at the National Institute of Mental Health. She had no relevant financial conflicts to disclose.

Body

Adolescence is a time of increased risk for many serious mental health problems, including suicide and substance abuse. The Wisconsin school-based screening initiative evaluated in this study is an important effort to identify adolescents who are at risk and to link them with appropriate services in the school or in the community.

This study, although limited because of its retrospective case design, provides some important information about the pervasiveness of the problem and some clues about the factors that may impede access to care.


Dr. Kayla Pope

It is alarming that only 42% of the adolescents referred for community-based care and 80% of the children referred for school-based treatment had one contact with a treatment provider. The percentages were even lower for both groups who received minimally adequate treatment (defined as three or more visits). Although there is no information on outcomes for the children who were identified as being at risk, the "adequacy" of treatment remains a significant question. It is also interesting to note that adolescents referred for community-based care, despite some evidence of higher acuity (rates of suicide and self-injurious behavior), were even less likely to access services.

The identification of adolescents at risk is an important first step, but the creation of delivery systems that ensure appropriate treatment is also critical. While school-based care is one model, an innovative alternative called Headspace (http://www.headspace.org.au) has been developed by a group in Australia. The program is designed to provide services to adolescents where they spend their time, namely on the Internet and in the community. The online component provides information about mental health problems, self assessments, and access to mental health professionals. Teens are then linked to community centers that provide mental health assessments and treatment in addition to providing other basic medical services.

Whether school-based or community-based, we need to do a better job providing for the mental health needs of this population.

Kayla Pope, M.D., J.D., is a clinical research fellow at the National Institute of Mental Health. She had no relevant financial conflicts to disclose.

Title
Creating Effective Delivery Systems Is Critical
Creating Effective Delivery Systems Is Critical

Systematic, voluntary mental health screening of high school students can help identify those who are at risk for serious mental health problems, and can connect them with much-needed care, a study of almost 2,500 adolescents suggests.

In addition, students who are referred for school-based mental health services are generally less severely ill than their counterparts who are referred for community-based services, with lower rates of self-reported suicidal ideation, depression, and substance abuse as well as lower interviewer-assessed rates of prior suicide attempts and self-injury.

The findings, reported in the September 2011 issue of the Journal of the American Academy of Child and Adolescent Psychiatry, come from a study that set out to identify the extent to which at-risk youth are identified and connected with appropriate mental health services.

"Research on post-screening access to care has been hindered by a paucity of information concerning follow-up with students referred to services," wrote the researchers, led by Mathilde M. Husky, Ph.D., of the New York State Psychiatric Institute at Columbia University. "When information is available, it is often limited to the first outpatient visit. As a result, it is not known what proportion of referred youth drop out early from follow-up care."

During 2005-2009, some 4,509 ninth graders at six public high schools in suburban Wisconsin were offered systematic voluntary mental health screening. Students completed a computerized self-report assessment known as the DPS-8 (Diagnostic Predictive Scales–8, an abbreviated form of the Diagnostic Interview Schedule for Children–IV). Students were deemed to be "at risk" if they screened positive or were identified by screening staff as being in need of further assessment (J. Am. Acad. Child Adolesc. Psychiatry 2011;50:881-91).

After the screening, each student was seen for a one-on-one debriefing to discuss the results. Students who screened positive on the self-report or who asked for help during the debriefing stayed for a second-stage clinical interview. After that, the interviewer offered referral to school-based services, community-based services, neither, or both.

Of the 4,509 students, 2,488 (56%) provided both parent consent and youth assent, and were included in the final analysis. Of the 2,488 students, 489 (20%) were identified as being at risk. Of these, 74% were not receiving any mental health services.

Overall, 74% of students were referred to school-based services, whereas 53% were referred to community-based services. In addition, 76% of referred students received at least one follow-up visit and 56% received minimally adequate treatment, which was defined as "having three or more visits with a given provider, or any number of visits if termination occurred in accordance with the provider’s recommendation."

Compared with students who were referred to school-based services, those who were referred to community-based services self-reported higher rates of suicidal ideation (26% vs. 11%, respectively), depression (50% vs. 41%), and substance abuse (17% vs. 9%). They also had higher rates of certain interviewer-assessed variables, including passive suicidal ideation (51% vs. 31%), active suicidal ideation (21% vs. 4%), prior suicide attempt (17% vs. 6%), and self-injury (33% vs. 14%). The researchers said that these findings are consistent with a 2005 report from the Substance Abuse and Mental Health Services Administration, "suggesting that youth with more serious problems are more commonly referred to community providers."

Among adolescents who received a referral to school-based services, 80% received at least one visit, compared with only 42% of those who received a referral to community-based services. "Referral decisions may be driven by specific symptoms, current distress, student or family preferences, past treatment experiences, provider availability, [and] logistical and economic considerations, as well as a host of other factors that were not measured in this study," Dr. Husky and her associates stated. "Although schools remain important providers of mental health services, our findings suggest that the implementation of proactive efforts to link youth with serious conditions to services may best be achieved when both school and community mental health providers are available."

Dr. David Fassler

In an interview, Dr. David Fassler, professor of psychiatry at the University of Vermont, Burlington, characterized the study’s findings as generally consistent with those of previous reports. "Signs of psychiatric disorders, including suicidal ideation, are not uncommon in adolescents," he said. "Yet most young people with significant symptoms receive little, if any, treatment. Schools are a logical place to try and identify students who may need help, and to facilitate referrals, as appropriate. However, as this study demonstrates, accessing follow-up care often remains a challenge, particularly when services are located outside the school setting."

Dr. Fassler went on to note that the study’s findings "will be useful in the development of programs and policies designed to identify at-risk students. They will also help inform future research on school-based screening initiatives."

 

 

The researchers acknowledged certain limitations of their study, including the lack of a control group and the potential for selection bias. "It is likely that parent refusal, related to stigma and other societal factors, diminished the rate of student participation," they wrote. "Furthermore, beyond the limitation that the modest participation rate poses to the generalizability of the sample, it also points to the constraints of the intervention as a substantial portion of adolescents does not have access to its potential benefits."

The researchers had no relevant financial conflicts to disclose.

Systematic, voluntary mental health screening of high school students can help identify those who are at risk for serious mental health problems, and can connect them with much-needed care, a study of almost 2,500 adolescents suggests.

In addition, students who are referred for school-based mental health services are generally less severely ill than their counterparts who are referred for community-based services, with lower rates of self-reported suicidal ideation, depression, and substance abuse as well as lower interviewer-assessed rates of prior suicide attempts and self-injury.

The findings, reported in the September 2011 issue of the Journal of the American Academy of Child and Adolescent Psychiatry, come from a study that set out to identify the extent to which at-risk youth are identified and connected with appropriate mental health services.

"Research on post-screening access to care has been hindered by a paucity of information concerning follow-up with students referred to services," wrote the researchers, led by Mathilde M. Husky, Ph.D., of the New York State Psychiatric Institute at Columbia University. "When information is available, it is often limited to the first outpatient visit. As a result, it is not known what proportion of referred youth drop out early from follow-up care."

During 2005-2009, some 4,509 ninth graders at six public high schools in suburban Wisconsin were offered systematic voluntary mental health screening. Students completed a computerized self-report assessment known as the DPS-8 (Diagnostic Predictive Scales–8, an abbreviated form of the Diagnostic Interview Schedule for Children–IV). Students were deemed to be "at risk" if they screened positive or were identified by screening staff as being in need of further assessment (J. Am. Acad. Child Adolesc. Psychiatry 2011;50:881-91).

After the screening, each student was seen for a one-on-one debriefing to discuss the results. Students who screened positive on the self-report or who asked for help during the debriefing stayed for a second-stage clinical interview. After that, the interviewer offered referral to school-based services, community-based services, neither, or both.

Of the 4,509 students, 2,488 (56%) provided both parent consent and youth assent, and were included in the final analysis. Of the 2,488 students, 489 (20%) were identified as being at risk. Of these, 74% were not receiving any mental health services.

Overall, 74% of students were referred to school-based services, whereas 53% were referred to community-based services. In addition, 76% of referred students received at least one follow-up visit and 56% received minimally adequate treatment, which was defined as "having three or more visits with a given provider, or any number of visits if termination occurred in accordance with the provider’s recommendation."

Compared with students who were referred to school-based services, those who were referred to community-based services self-reported higher rates of suicidal ideation (26% vs. 11%, respectively), depression (50% vs. 41%), and substance abuse (17% vs. 9%). They also had higher rates of certain interviewer-assessed variables, including passive suicidal ideation (51% vs. 31%), active suicidal ideation (21% vs. 4%), prior suicide attempt (17% vs. 6%), and self-injury (33% vs. 14%). The researchers said that these findings are consistent with a 2005 report from the Substance Abuse and Mental Health Services Administration, "suggesting that youth with more serious problems are more commonly referred to community providers."

Among adolescents who received a referral to school-based services, 80% received at least one visit, compared with only 42% of those who received a referral to community-based services. "Referral decisions may be driven by specific symptoms, current distress, student or family preferences, past treatment experiences, provider availability, [and] logistical and economic considerations, as well as a host of other factors that were not measured in this study," Dr. Husky and her associates stated. "Although schools remain important providers of mental health services, our findings suggest that the implementation of proactive efforts to link youth with serious conditions to services may best be achieved when both school and community mental health providers are available."

Dr. David Fassler

In an interview, Dr. David Fassler, professor of psychiatry at the University of Vermont, Burlington, characterized the study’s findings as generally consistent with those of previous reports. "Signs of psychiatric disorders, including suicidal ideation, are not uncommon in adolescents," he said. "Yet most young people with significant symptoms receive little, if any, treatment. Schools are a logical place to try and identify students who may need help, and to facilitate referrals, as appropriate. However, as this study demonstrates, accessing follow-up care often remains a challenge, particularly when services are located outside the school setting."

Dr. Fassler went on to note that the study’s findings "will be useful in the development of programs and policies designed to identify at-risk students. They will also help inform future research on school-based screening initiatives."

 

 

The researchers acknowledged certain limitations of their study, including the lack of a control group and the potential for selection bias. "It is likely that parent refusal, related to stigma and other societal factors, diminished the rate of student participation," they wrote. "Furthermore, beyond the limitation that the modest participation rate poses to the generalizability of the sample, it also points to the constraints of the intervention as a substantial portion of adolescents does not have access to its potential benefits."

The researchers had no relevant financial conflicts to disclose.

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Major Finding: Among adolescents who received a referral to school-based mental health services, 80% received at least one visit, compared with only 42% of those who received a referral to community-based mental health services. In addition, those who were referred to community-based mental services had higher rates of self-reported suicidal ideation (26% vs. 11%, respectively), depression (50% vs. 41%), and substance abuse (17% vs. 9%). They also had higher rates of certain interviewer-assessed variables, including passive suicidal ideation (51% vs. 31%), active suicidal ideation (21% vs. 4%), prior suicide attempt (17% vs. 6%), and self-injury (33% vs. 14%).

Data Source: A study of 2,488 ninth graders from six public high schools in suburban Wisconsin who underwent voluntary mental health screening in 2005-2009.

Disclosures: The researchers had no relevant financial conflicts to disclose.

Understanding of Probiotics 'Still in Its Infancy'

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SAN DIEGO – With consumers buzzing about the advertised benefits of probiotics for a healthy gut, what’s a primary care physician to recommend?

At a meeting on primary care medicine sponsored by the Scripps Clinic, Dr. Walter J. Coyle emphasized that while probiotics may play a role in the treatment and management of certain gastroenterological conditions, "there are not a lot of well-done randomized, placebo-controlled trials of these drugs. Most GI physicians use probiotics regularly, but our understanding of how these products work and interact with our immune systems and gut lining is still in its infancy."

The majority of probiotics are gram-positive lactic acid producers such as Bifidobacterium and Lactobacillus species, "which survive in transit through the stomach and duodenum," said Dr. Coyle, a gastroenterologist who directs the Scripps Clinic Gastroenterology Fellowship Program. Others include nonpathogenic streptococci, enterococci, Escherichia coli Nissle 1917, and Saccharomyces boulardii (yeast).

Dr. Coyle discussed the potential benefits of several probiotics on the market:

– VSL #3. This product contains four lactobacilli organisms (L. plantarum, casei, acidopholus, and delbrueckii), three bifidobacteria organisms (B. infantis, breve, and longum), and one streptococcus organism (Streptococcus salivarius subsp. thermophilus). "It’s fairly expensive and has to be kept refrigerated," Dr. Coyle said. "Randomized placebo-controlled trials have shown it’s very good for pouchitis." A more recent study of its use in ulcerative colitis patients found that it was superior to placebo in mild to moderate activity (Am. J. Gastroenterol. 2010; 105:2218-27). "It’s not one of my first-line therapies for inflammatory bowel disease, but it is out there as an alternative," he said.

– Digestive Advantage for IBS. This product contains Ganeden BC30, a patented bacteria strain of Bacillus coagulans, erythritol, cellulose, and other minor ingredients. One small, randomized, double-blind, placebo-controlled trial found it to be an effective treatment of abdominal pain and bloating in patients with irritable bowel syndrome (Postgrad. Med. 2009;121 [doi: 10.3810/pgm.2009.03.1984]). "I’ll try it if the patients fail to have symptom improvement with other therapies, but there are no really well done randomized, placebo-controlled trials, which is the problem with most probiotics," Dr. Coyle said.

– Align. This product contains a patented strain of Bifidobacterium infantis 35624. In two large trials, it demonstrated decreased symptoms in IBS patients, "mostly in bloating and a little bit on flatulence," he said. This probiotic was also shown in trials to decrease the mucosal levels of IL-6, a known inflammatory cytokine. (See Gastroenterol. 2005;128:541-51 and Am. J. Gastroenterol. 2006;101:1581-90.) "I often try Align for my irritable bowel patients," he said.

– Florastor (Saccharomyces boulardii). This product has been shown to help prevent recurrent Clostridium difficile infections and to decrease diarrhea associated with antibiotic use. The dosing in one randomized, placebo-controlled study (JAMA 1994;271:1913-8) was two tablets twice per day, "which is expensive," Dr. Coyle said. "I typically recommend one tablet twice a day. However, for those patients who have had multiple recurrences of C. difficile, I do use the higher dose of two tablets twice per day."

– Actimel. This yogurt-type drink contains the patented yogurt culture known as Lactobacillus casei Immunitas. In a 2007 randomized, placebo-controlled trial of 135 hospitalized patients on antibiotics, those who received an Actimel-like product were significantly less likely to develop hospital-acquired diarrhea, compared with those who received placebo (12% vs. 34%, respectively). A similar association was seen in the prevention of hospital-acquired C. difficile (BMJ 2007;335:80 [doi: 10.1136/bmj.39231.599815.55]).

In this trial, "you only needed to treat five patients to prevent one case of hospital-acquired diarrhea, and you only needed to treat six patients to prevent one case of hospital-acquired C. difficile," Dr. Coyle said. "Why are we not doing this in the hospital?"

– Activia. This yogurt product contains Bifidus regularis and Bifidobacterium animus, and has been shown in scientific studies to increase transit time in women and in older adults. "If you like the taste of Activia, take it," he commented. "I don’t think I’d take it for making your gut healthier. It may, but we don’t have the data. It does help in patients who are often constipated. I’m fine with that, but I’m not sure I would classify it as a medical food."

– Culturelle. This product contains Lactobacillus rhamnosus GG and has been shown in scientific studies to be superior to placebo for diarrheal illnesses. "It’s proven to survive transit through the stomach and small intestine, and binds to human colonocytes," Dr. Coyle said. "It’s a reasonable choice for diarrhea patients and it’s been around for a long time."

He noted that current studies of prebiotics – ingested substances that selectively stimulate the proliferation or activity of desirable bacterial populations present in the host intestinal tract – have the potential for significant impact in the field of gastroenterology. "Is it possible to design a food, sugar, protein, or fat that would alter your gut flora to promote weight loss? That concept is exciting," he said. "I think you’re going to see a lot coming down the line on this."

 

 

Dr. Coyle said that he had no relevant financial disclosures.

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SAN DIEGO – With consumers buzzing about the advertised benefits of probiotics for a healthy gut, what’s a primary care physician to recommend?

At a meeting on primary care medicine sponsored by the Scripps Clinic, Dr. Walter J. Coyle emphasized that while probiotics may play a role in the treatment and management of certain gastroenterological conditions, "there are not a lot of well-done randomized, placebo-controlled trials of these drugs. Most GI physicians use probiotics regularly, but our understanding of how these products work and interact with our immune systems and gut lining is still in its infancy."

The majority of probiotics are gram-positive lactic acid producers such as Bifidobacterium and Lactobacillus species, "which survive in transit through the stomach and duodenum," said Dr. Coyle, a gastroenterologist who directs the Scripps Clinic Gastroenterology Fellowship Program. Others include nonpathogenic streptococci, enterococci, Escherichia coli Nissle 1917, and Saccharomyces boulardii (yeast).

Dr. Coyle discussed the potential benefits of several probiotics on the market:

– VSL #3. This product contains four lactobacilli organisms (L. plantarum, casei, acidopholus, and delbrueckii), three bifidobacteria organisms (B. infantis, breve, and longum), and one streptococcus organism (Streptococcus salivarius subsp. thermophilus). "It’s fairly expensive and has to be kept refrigerated," Dr. Coyle said. "Randomized placebo-controlled trials have shown it’s very good for pouchitis." A more recent study of its use in ulcerative colitis patients found that it was superior to placebo in mild to moderate activity (Am. J. Gastroenterol. 2010; 105:2218-27). "It’s not one of my first-line therapies for inflammatory bowel disease, but it is out there as an alternative," he said.

– Digestive Advantage for IBS. This product contains Ganeden BC30, a patented bacteria strain of Bacillus coagulans, erythritol, cellulose, and other minor ingredients. One small, randomized, double-blind, placebo-controlled trial found it to be an effective treatment of abdominal pain and bloating in patients with irritable bowel syndrome (Postgrad. Med. 2009;121 [doi: 10.3810/pgm.2009.03.1984]). "I’ll try it if the patients fail to have symptom improvement with other therapies, but there are no really well done randomized, placebo-controlled trials, which is the problem with most probiotics," Dr. Coyle said.

– Align. This product contains a patented strain of Bifidobacterium infantis 35624. In two large trials, it demonstrated decreased symptoms in IBS patients, "mostly in bloating and a little bit on flatulence," he said. This probiotic was also shown in trials to decrease the mucosal levels of IL-6, a known inflammatory cytokine. (See Gastroenterol. 2005;128:541-51 and Am. J. Gastroenterol. 2006;101:1581-90.) "I often try Align for my irritable bowel patients," he said.

– Florastor (Saccharomyces boulardii). This product has been shown to help prevent recurrent Clostridium difficile infections and to decrease diarrhea associated with antibiotic use. The dosing in one randomized, placebo-controlled study (JAMA 1994;271:1913-8) was two tablets twice per day, "which is expensive," Dr. Coyle said. "I typically recommend one tablet twice a day. However, for those patients who have had multiple recurrences of C. difficile, I do use the higher dose of two tablets twice per day."

– Actimel. This yogurt-type drink contains the patented yogurt culture known as Lactobacillus casei Immunitas. In a 2007 randomized, placebo-controlled trial of 135 hospitalized patients on antibiotics, those who received an Actimel-like product were significantly less likely to develop hospital-acquired diarrhea, compared with those who received placebo (12% vs. 34%, respectively). A similar association was seen in the prevention of hospital-acquired C. difficile (BMJ 2007;335:80 [doi: 10.1136/bmj.39231.599815.55]).

In this trial, "you only needed to treat five patients to prevent one case of hospital-acquired diarrhea, and you only needed to treat six patients to prevent one case of hospital-acquired C. difficile," Dr. Coyle said. "Why are we not doing this in the hospital?"

– Activia. This yogurt product contains Bifidus regularis and Bifidobacterium animus, and has been shown in scientific studies to increase transit time in women and in older adults. "If you like the taste of Activia, take it," he commented. "I don’t think I’d take it for making your gut healthier. It may, but we don’t have the data. It does help in patients who are often constipated. I’m fine with that, but I’m not sure I would classify it as a medical food."

– Culturelle. This product contains Lactobacillus rhamnosus GG and has been shown in scientific studies to be superior to placebo for diarrheal illnesses. "It’s proven to survive transit through the stomach and small intestine, and binds to human colonocytes," Dr. Coyle said. "It’s a reasonable choice for diarrhea patients and it’s been around for a long time."

He noted that current studies of prebiotics – ingested substances that selectively stimulate the proliferation or activity of desirable bacterial populations present in the host intestinal tract – have the potential for significant impact in the field of gastroenterology. "Is it possible to design a food, sugar, protein, or fat that would alter your gut flora to promote weight loss? That concept is exciting," he said. "I think you’re going to see a lot coming down the line on this."

 

 

Dr. Coyle said that he had no relevant financial disclosures.

SAN DIEGO – With consumers buzzing about the advertised benefits of probiotics for a healthy gut, what’s a primary care physician to recommend?

At a meeting on primary care medicine sponsored by the Scripps Clinic, Dr. Walter J. Coyle emphasized that while probiotics may play a role in the treatment and management of certain gastroenterological conditions, "there are not a lot of well-done randomized, placebo-controlled trials of these drugs. Most GI physicians use probiotics regularly, but our understanding of how these products work and interact with our immune systems and gut lining is still in its infancy."

The majority of probiotics are gram-positive lactic acid producers such as Bifidobacterium and Lactobacillus species, "which survive in transit through the stomach and duodenum," said Dr. Coyle, a gastroenterologist who directs the Scripps Clinic Gastroenterology Fellowship Program. Others include nonpathogenic streptococci, enterococci, Escherichia coli Nissle 1917, and Saccharomyces boulardii (yeast).

Dr. Coyle discussed the potential benefits of several probiotics on the market:

– VSL #3. This product contains four lactobacilli organisms (L. plantarum, casei, acidopholus, and delbrueckii), three bifidobacteria organisms (B. infantis, breve, and longum), and one streptococcus organism (Streptococcus salivarius subsp. thermophilus). "It’s fairly expensive and has to be kept refrigerated," Dr. Coyle said. "Randomized placebo-controlled trials have shown it’s very good for pouchitis." A more recent study of its use in ulcerative colitis patients found that it was superior to placebo in mild to moderate activity (Am. J. Gastroenterol. 2010; 105:2218-27). "It’s not one of my first-line therapies for inflammatory bowel disease, but it is out there as an alternative," he said.

– Digestive Advantage for IBS. This product contains Ganeden BC30, a patented bacteria strain of Bacillus coagulans, erythritol, cellulose, and other minor ingredients. One small, randomized, double-blind, placebo-controlled trial found it to be an effective treatment of abdominal pain and bloating in patients with irritable bowel syndrome (Postgrad. Med. 2009;121 [doi: 10.3810/pgm.2009.03.1984]). "I’ll try it if the patients fail to have symptom improvement with other therapies, but there are no really well done randomized, placebo-controlled trials, which is the problem with most probiotics," Dr. Coyle said.

– Align. This product contains a patented strain of Bifidobacterium infantis 35624. In two large trials, it demonstrated decreased symptoms in IBS patients, "mostly in bloating and a little bit on flatulence," he said. This probiotic was also shown in trials to decrease the mucosal levels of IL-6, a known inflammatory cytokine. (See Gastroenterol. 2005;128:541-51 and Am. J. Gastroenterol. 2006;101:1581-90.) "I often try Align for my irritable bowel patients," he said.

– Florastor (Saccharomyces boulardii). This product has been shown to help prevent recurrent Clostridium difficile infections and to decrease diarrhea associated with antibiotic use. The dosing in one randomized, placebo-controlled study (JAMA 1994;271:1913-8) was two tablets twice per day, "which is expensive," Dr. Coyle said. "I typically recommend one tablet twice a day. However, for those patients who have had multiple recurrences of C. difficile, I do use the higher dose of two tablets twice per day."

– Actimel. This yogurt-type drink contains the patented yogurt culture known as Lactobacillus casei Immunitas. In a 2007 randomized, placebo-controlled trial of 135 hospitalized patients on antibiotics, those who received an Actimel-like product were significantly less likely to develop hospital-acquired diarrhea, compared with those who received placebo (12% vs. 34%, respectively). A similar association was seen in the prevention of hospital-acquired C. difficile (BMJ 2007;335:80 [doi: 10.1136/bmj.39231.599815.55]).

In this trial, "you only needed to treat five patients to prevent one case of hospital-acquired diarrhea, and you only needed to treat six patients to prevent one case of hospital-acquired C. difficile," Dr. Coyle said. "Why are we not doing this in the hospital?"

– Activia. This yogurt product contains Bifidus regularis and Bifidobacterium animus, and has been shown in scientific studies to increase transit time in women and in older adults. "If you like the taste of Activia, take it," he commented. "I don’t think I’d take it for making your gut healthier. It may, but we don’t have the data. It does help in patients who are often constipated. I’m fine with that, but I’m not sure I would classify it as a medical food."

– Culturelle. This product contains Lactobacillus rhamnosus GG and has been shown in scientific studies to be superior to placebo for diarrheal illnesses. "It’s proven to survive transit through the stomach and small intestine, and binds to human colonocytes," Dr. Coyle said. "It’s a reasonable choice for diarrhea patients and it’s been around for a long time."

He noted that current studies of prebiotics – ingested substances that selectively stimulate the proliferation or activity of desirable bacterial populations present in the host intestinal tract – have the potential for significant impact in the field of gastroenterology. "Is it possible to design a food, sugar, protein, or fat that would alter your gut flora to promote weight loss? That concept is exciting," he said. "I think you’re going to see a lot coming down the line on this."

 

 

Dr. Coyle said that he had no relevant financial disclosures.

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EXPERT ANALYSIS FROM A MEETING ON PRIMARY CARE MEDICINE SPONSORED BY THE SCRIPPS CLINIC

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Hospitalist Care Study Looks Back, Not Ahead

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Leading hospitalists are calling a recent study that links hospitalist care with higher post-discharge medical utilization and costs a glimpse at the past, rather than a snapshot of today’s practices.

In the study, inpatients managed by hospitalists had, on average, 0.64 fewer days of hospitalization and $282 less in hospital costs as compared with inpatients managed by their primary care physician. In the first 30 days after discharge, however, Medicare costs were $332 higher in patients who received care from hospitalists. Additionally, patients cared for by hospitalists were less likely to be discharged home (odds ratio 0.82). Further, these patients were more likely in the 30-day period to have emergency department visits (OR 1.18) and to be readmitted to the hospital (OR 1.08).

The study, conducted by Yong-Fang Kuo, Ph.D., and Dr. James S. Goodwin of the department of internal medicine at the University of Texas Medical Branch, Galveston, drew its findings from a 5% national sample of Medicare patients, which consisted of 58,125 admissions at 454 hospitals between 2001 and 2006 (Ann. Intern Med. 2011;155:152-9).

    Dr. Michael J. Pistoria

Dr. Alpesh Amin, professor and chair of the department of medicine and executive director of the hospitalist program at the University of California, Irvine, called patient encounters between 2001 and 2006 "early in the course of the hospitalist movement ... I wonder [if] the findings would be the same if the researchers had looked at 2008-2011, for example."

The researchers also acknowledged limitations of the study and wrote "our results may not be applicable to patients without an identified PCP," as the study selectively compared care by hospitalists and care by identified primary care physicians who personally provided care for their hospitalized patients. "In addition, the study included only patients admitted with medical diagnoses. Hospitalists have a smaller effect on length of stay with surgical patients, so the results may differ. Also, we did not include patients cared for by medical subspecialists who were hospitalists. Another limitation is that we studied patients with fee-for-service Medicare coverage."

Dr. Michael J. Pistoria, president of the medical staff and associate chief of the division of general internal medicine at Lehigh Valley Health Network, Allentown, Pa., contrasted the environment at the time of study with ongoing initiatives in hospitalist practice.

"If you look at hospital medicine’s growth, our first several years in the ‘limelight’ were focused on demonstrating that we provide efficient and high-quality care in the hospital. As we have evolved as a specialty, our focus has shifted to the impact of our care (and its built-in discontinuity) outside of the hospital. Specifically, we have seen new research and major projects [like the Better Outcomes for Older Adults Through Safe Transitions, or BOOST] that now examine and evaluate our transitions of care," Dr. Pistoria said in an interview.

While it remains unclear what kind of impact the findings will have on hospital medicine going forward, the study "is good for our patients and good for hospital medicine in that it reinforces our need to improve care along the inpatient-outpatient continuum," he said.

Dr. Amir K. Jaffer, division chief of hospital medicine at the University of Miami, similarly lauded the progress of nationwide quality improvement projects, such as BOOST and Project RED (Re-Engineered Discharge), designed to bolster efforts to lower readmission rates and post-discharge costs.

"The innovative bundling of payments that is planned by CMS also should help," Dr. Jaffer said. "Increasing costs of care after discharge could be addressed by [creating incentives for] physicians to focus on the patients’ whole episode of care rather than just focusing on the hospitalization," he said.

"Clearly, we have work to do to improve care transitions, as do our primary care physician colleagues," Dr. Pistoria said. "This paper will spur further research into care transitions and efforts to improve the flow of information between various care settings."

The study was funded by the National Institute on Aging and the National Cancer Institute.

Dr. Kuo and Dr. Goodwin stated that they had no relevant financial conflicts to disclose.

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Leading hospitalists are calling a recent study that links hospitalist care with higher post-discharge medical utilization and costs a glimpse at the past, rather than a snapshot of today’s practices.

In the study, inpatients managed by hospitalists had, on average, 0.64 fewer days of hospitalization and $282 less in hospital costs as compared with inpatients managed by their primary care physician. In the first 30 days after discharge, however, Medicare costs were $332 higher in patients who received care from hospitalists. Additionally, patients cared for by hospitalists were less likely to be discharged home (odds ratio 0.82). Further, these patients were more likely in the 30-day period to have emergency department visits (OR 1.18) and to be readmitted to the hospital (OR 1.08).

The study, conducted by Yong-Fang Kuo, Ph.D., and Dr. James S. Goodwin of the department of internal medicine at the University of Texas Medical Branch, Galveston, drew its findings from a 5% national sample of Medicare patients, which consisted of 58,125 admissions at 454 hospitals between 2001 and 2006 (Ann. Intern Med. 2011;155:152-9).

    Dr. Michael J. Pistoria

Dr. Alpesh Amin, professor and chair of the department of medicine and executive director of the hospitalist program at the University of California, Irvine, called patient encounters between 2001 and 2006 "early in the course of the hospitalist movement ... I wonder [if] the findings would be the same if the researchers had looked at 2008-2011, for example."

The researchers also acknowledged limitations of the study and wrote "our results may not be applicable to patients without an identified PCP," as the study selectively compared care by hospitalists and care by identified primary care physicians who personally provided care for their hospitalized patients. "In addition, the study included only patients admitted with medical diagnoses. Hospitalists have a smaller effect on length of stay with surgical patients, so the results may differ. Also, we did not include patients cared for by medical subspecialists who were hospitalists. Another limitation is that we studied patients with fee-for-service Medicare coverage."

Dr. Michael J. Pistoria, president of the medical staff and associate chief of the division of general internal medicine at Lehigh Valley Health Network, Allentown, Pa., contrasted the environment at the time of study with ongoing initiatives in hospitalist practice.

"If you look at hospital medicine’s growth, our first several years in the ‘limelight’ were focused on demonstrating that we provide efficient and high-quality care in the hospital. As we have evolved as a specialty, our focus has shifted to the impact of our care (and its built-in discontinuity) outside of the hospital. Specifically, we have seen new research and major projects [like the Better Outcomes for Older Adults Through Safe Transitions, or BOOST] that now examine and evaluate our transitions of care," Dr. Pistoria said in an interview.

While it remains unclear what kind of impact the findings will have on hospital medicine going forward, the study "is good for our patients and good for hospital medicine in that it reinforces our need to improve care along the inpatient-outpatient continuum," he said.

Dr. Amir K. Jaffer, division chief of hospital medicine at the University of Miami, similarly lauded the progress of nationwide quality improvement projects, such as BOOST and Project RED (Re-Engineered Discharge), designed to bolster efforts to lower readmission rates and post-discharge costs.

"The innovative bundling of payments that is planned by CMS also should help," Dr. Jaffer said. "Increasing costs of care after discharge could be addressed by [creating incentives for] physicians to focus on the patients’ whole episode of care rather than just focusing on the hospitalization," he said.

"Clearly, we have work to do to improve care transitions, as do our primary care physician colleagues," Dr. Pistoria said. "This paper will spur further research into care transitions and efforts to improve the flow of information between various care settings."

The study was funded by the National Institute on Aging and the National Cancer Institute.

Dr. Kuo and Dr. Goodwin stated that they had no relevant financial conflicts to disclose.

Leading hospitalists are calling a recent study that links hospitalist care with higher post-discharge medical utilization and costs a glimpse at the past, rather than a snapshot of today’s practices.

In the study, inpatients managed by hospitalists had, on average, 0.64 fewer days of hospitalization and $282 less in hospital costs as compared with inpatients managed by their primary care physician. In the first 30 days after discharge, however, Medicare costs were $332 higher in patients who received care from hospitalists. Additionally, patients cared for by hospitalists were less likely to be discharged home (odds ratio 0.82). Further, these patients were more likely in the 30-day period to have emergency department visits (OR 1.18) and to be readmitted to the hospital (OR 1.08).

The study, conducted by Yong-Fang Kuo, Ph.D., and Dr. James S. Goodwin of the department of internal medicine at the University of Texas Medical Branch, Galveston, drew its findings from a 5% national sample of Medicare patients, which consisted of 58,125 admissions at 454 hospitals between 2001 and 2006 (Ann. Intern Med. 2011;155:152-9).

    Dr. Michael J. Pistoria

Dr. Alpesh Amin, professor and chair of the department of medicine and executive director of the hospitalist program at the University of California, Irvine, called patient encounters between 2001 and 2006 "early in the course of the hospitalist movement ... I wonder [if] the findings would be the same if the researchers had looked at 2008-2011, for example."

The researchers also acknowledged limitations of the study and wrote "our results may not be applicable to patients without an identified PCP," as the study selectively compared care by hospitalists and care by identified primary care physicians who personally provided care for their hospitalized patients. "In addition, the study included only patients admitted with medical diagnoses. Hospitalists have a smaller effect on length of stay with surgical patients, so the results may differ. Also, we did not include patients cared for by medical subspecialists who were hospitalists. Another limitation is that we studied patients with fee-for-service Medicare coverage."

Dr. Michael J. Pistoria, president of the medical staff and associate chief of the division of general internal medicine at Lehigh Valley Health Network, Allentown, Pa., contrasted the environment at the time of study with ongoing initiatives in hospitalist practice.

"If you look at hospital medicine’s growth, our first several years in the ‘limelight’ were focused on demonstrating that we provide efficient and high-quality care in the hospital. As we have evolved as a specialty, our focus has shifted to the impact of our care (and its built-in discontinuity) outside of the hospital. Specifically, we have seen new research and major projects [like the Better Outcomes for Older Adults Through Safe Transitions, or BOOST] that now examine and evaluate our transitions of care," Dr. Pistoria said in an interview.

While it remains unclear what kind of impact the findings will have on hospital medicine going forward, the study "is good for our patients and good for hospital medicine in that it reinforces our need to improve care along the inpatient-outpatient continuum," he said.

Dr. Amir K. Jaffer, division chief of hospital medicine at the University of Miami, similarly lauded the progress of nationwide quality improvement projects, such as BOOST and Project RED (Re-Engineered Discharge), designed to bolster efforts to lower readmission rates and post-discharge costs.

"The innovative bundling of payments that is planned by CMS also should help," Dr. Jaffer said. "Increasing costs of care after discharge could be addressed by [creating incentives for] physicians to focus on the patients’ whole episode of care rather than just focusing on the hospitalization," he said.

"Clearly, we have work to do to improve care transitions, as do our primary care physician colleagues," Dr. Pistoria said. "This paper will spur further research into care transitions and efforts to improve the flow of information between various care settings."

The study was funded by the National Institute on Aging and the National Cancer Institute.

Dr. Kuo and Dr. Goodwin stated that they had no relevant financial conflicts to disclose.

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Major Finding: While hospital charges were $282 lower for patients cared for by a hospitalist, compared with those cared for by their primary care physician, hospitalist care was associated with $332 more Medicare spending in the first 30 days after discharge.

Data Source: A study of 58,125 Medicare admissions at 454 hospitals from 2001-2006.

Disclosures: The study was funded by the National Institute on Aging and the National Cancer Institute.

Consider Granulation Options After Dermatologic Surgery

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SAN DIEGO – To granulate or not to granulate? That’s the question clinicians may consider after performing dermatologic surgery.

The best sites for granulation are concavities of the temple, ear, eye, and nose, Dr. Malcolm S. Ke said at a meeting on superficial anatomy and cutaneous surgery. "Sometimes superficial convexities also do quite well, such as the nose, mucosal lip, ear, and scalp," he added. "Deeper convexities are less predictable."

Benefits of granulation include easy monitoring and a low infection rate. "There is no hematoma and no suture reactions," said Dr. Ke of the division of dermatology at the University of California, Los Angeles. "It’s one less procedure the patient has to tolerate, it is often less painful for the patient, and it can provide good cosmesis."

Drawbacks include the potential for a long healing time and the fact that wound care is patient dependent. "They have to take care of it every single day, and there is sometimes a less predictable outcome," Dr. Ke said.

Three main agents for preoperative wound care include alcohol 70%, lodophors, and chlorhexidine, "which is my favorite," he said. "It is bactericidal and antipseudomonal. It persists on the skin and is not absorbed, but it is not good for open wounds or around eyes."

Postoperatively, saline works well for keeping wounds clean. "A patient favorite is hydrogen peroxide, but it’s not that antimicrobial and it can be drying if you use it for a long time," Dr. Ke said.

Acetic acid and sodium hypochlorite are antipseudomonal options.

Topical antibiotics for consideration include bacitracin and polymyxin B (Polysporin) and bacitracin, neomycin, and polymyxin B (Neosporin), but both carry the risk of allergic reactions, he said. He also said he often recommends petroleum-based ointments such Vaseline or Aquaphor.

Mupirocin 2% "is a favorite for granulating wounds on the lower extremities when you worry about gram-positive and gram-negative coverage. I typically use silver sulfadiazine 1%."

Dr. Ke uses nonstick pads to cover wounds and occlusive dressings to match the wound type, including polyurethane foams, polyurethane films, hydrocolloids, hydrogels, alginates, and Unna’s boot. He sees patients every 1-2 weeks if necessary to check their wounds, "but if they need to be seen more often I’m there for them. You want to be supportive. Excess fibrin and debris can form on the area."

The meeting was sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic. Dr. Ke said that he had no relevant financial conflicts to disclose.

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SAN DIEGO – To granulate or not to granulate? That’s the question clinicians may consider after performing dermatologic surgery.

The best sites for granulation are concavities of the temple, ear, eye, and nose, Dr. Malcolm S. Ke said at a meeting on superficial anatomy and cutaneous surgery. "Sometimes superficial convexities also do quite well, such as the nose, mucosal lip, ear, and scalp," he added. "Deeper convexities are less predictable."

Benefits of granulation include easy monitoring and a low infection rate. "There is no hematoma and no suture reactions," said Dr. Ke of the division of dermatology at the University of California, Los Angeles. "It’s one less procedure the patient has to tolerate, it is often less painful for the patient, and it can provide good cosmesis."

Drawbacks include the potential for a long healing time and the fact that wound care is patient dependent. "They have to take care of it every single day, and there is sometimes a less predictable outcome," Dr. Ke said.

Three main agents for preoperative wound care include alcohol 70%, lodophors, and chlorhexidine, "which is my favorite," he said. "It is bactericidal and antipseudomonal. It persists on the skin and is not absorbed, but it is not good for open wounds or around eyes."

Postoperatively, saline works well for keeping wounds clean. "A patient favorite is hydrogen peroxide, but it’s not that antimicrobial and it can be drying if you use it for a long time," Dr. Ke said.

Acetic acid and sodium hypochlorite are antipseudomonal options.

Topical antibiotics for consideration include bacitracin and polymyxin B (Polysporin) and bacitracin, neomycin, and polymyxin B (Neosporin), but both carry the risk of allergic reactions, he said. He also said he often recommends petroleum-based ointments such Vaseline or Aquaphor.

Mupirocin 2% "is a favorite for granulating wounds on the lower extremities when you worry about gram-positive and gram-negative coverage. I typically use silver sulfadiazine 1%."

Dr. Ke uses nonstick pads to cover wounds and occlusive dressings to match the wound type, including polyurethane foams, polyurethane films, hydrocolloids, hydrogels, alginates, and Unna’s boot. He sees patients every 1-2 weeks if necessary to check their wounds, "but if they need to be seen more often I’m there for them. You want to be supportive. Excess fibrin and debris can form on the area."

The meeting was sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic. Dr. Ke said that he had no relevant financial conflicts to disclose.

SAN DIEGO – To granulate or not to granulate? That’s the question clinicians may consider after performing dermatologic surgery.

The best sites for granulation are concavities of the temple, ear, eye, and nose, Dr. Malcolm S. Ke said at a meeting on superficial anatomy and cutaneous surgery. "Sometimes superficial convexities also do quite well, such as the nose, mucosal lip, ear, and scalp," he added. "Deeper convexities are less predictable."

Benefits of granulation include easy monitoring and a low infection rate. "There is no hematoma and no suture reactions," said Dr. Ke of the division of dermatology at the University of California, Los Angeles. "It’s one less procedure the patient has to tolerate, it is often less painful for the patient, and it can provide good cosmesis."

Drawbacks include the potential for a long healing time and the fact that wound care is patient dependent. "They have to take care of it every single day, and there is sometimes a less predictable outcome," Dr. Ke said.

Three main agents for preoperative wound care include alcohol 70%, lodophors, and chlorhexidine, "which is my favorite," he said. "It is bactericidal and antipseudomonal. It persists on the skin and is not absorbed, but it is not good for open wounds or around eyes."

Postoperatively, saline works well for keeping wounds clean. "A patient favorite is hydrogen peroxide, but it’s not that antimicrobial and it can be drying if you use it for a long time," Dr. Ke said.

Acetic acid and sodium hypochlorite are antipseudomonal options.

Topical antibiotics for consideration include bacitracin and polymyxin B (Polysporin) and bacitracin, neomycin, and polymyxin B (Neosporin), but both carry the risk of allergic reactions, he said. He also said he often recommends petroleum-based ointments such Vaseline or Aquaphor.

Mupirocin 2% "is a favorite for granulating wounds on the lower extremities when you worry about gram-positive and gram-negative coverage. I typically use silver sulfadiazine 1%."

Dr. Ke uses nonstick pads to cover wounds and occlusive dressings to match the wound type, including polyurethane foams, polyurethane films, hydrocolloids, hydrogels, alginates, and Unna’s boot. He sees patients every 1-2 weeks if necessary to check their wounds, "but if they need to be seen more often I’m there for them. You want to be supportive. Excess fibrin and debris can form on the area."

The meeting was sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic. Dr. Ke said that he had no relevant financial conflicts to disclose.

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Hand Osteoarthritis Affects More Women Than Men

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Hand osteoarthritis becomes more prevalent with advancing age and is more common in women than men, but not in all joint areas, results from a long-term analysis demonstrated.

Over 9 years of follow-up, more men than women developed metacarpal and wrist osteoarthritis (OA), yet more women than men developed erosive and symptomatic OA, according to a report by researchers led by Dr. Ida K. Haugen of the department of rheumatology at Diakonhjemmet Hospital, Oslo, that was published in the September 2011 edition of the Annals of the Rheumatic Diseases.

In what they describe as the first study of its kind, the researchers analyzed data from 2,300 adults who participated in the Framingham OA Study to determine the prevalence and course of radiographic, erosive, and symptomatic hand OA in the general population. All study participants had bilateral hand radiographs at baseline and at 9-year follow-up (Ann. Rheum. Dis. 2011;70:1581-6).

Dr. Ida Haugen and her associates defined radiographic hand OA at the joint level as a Kellgren-Lawrence scale grade 2 or greater, erosive hand OA as a Kellgren-Lawrence grade 2 or greater plus erosion, and symptomatic hand OA as a Kellgren-Lawrence grade 2 or greater plus pain/aching/stiffness. Study participants with one or more affected joint were classified as having hand OA.

The mean age of the study participants was 59 years, 57% were women, and 96% were white. The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Over the 9 years of follow-up, the crude incidence was similar between women and men (35% vs. 34%, respectively), whereas 96% of women and 91% of men who had hand OA at baseline showed progression during follow-up.

The researchers also reported that metacarpophalangeal and wrist OA occurred more frequently and from a younger age in men, compared with women, and that development of erosive disease occurred more frequently in women, compared with men (17% vs. 10%, respectively).

"Consistent with previous studies, we found no clear evidence of higher hand OA incidence in the right hand (usually dominant)," the researchers wrote. "The symmetrical joint affection indicates that ‘wear and tear’ alone is not sufficient to explain the pattern of hand OA, and neurogenic and hormonal influences have been suggested."

They acknowledged certain limitations of the study, including the fact that participants were from a limited geographic area, which makes it "uncertain whether the results can be generalized to larger geographical areas or [nonwhite] groups," they wrote. "The offspring cohort [of the Framingham OA Study] was not randomly selected from the population. However, the participants were not chosen based on joint symptoms, and previous studies have indicated that the cohort is reasonably representative of the US population. The mean time of follow-up was 9 years, and almost all participants showed progression, making discrimination between groups difficult. It is possible but unproven that reading of radiographs in known time sequence may lead to overestimation of progression."

The Framingham Osteoarthritis Study is supported by the National Institutes of Health. Dr. Haugen disclosed that she received grants from the South-Eastern Norway Regional Health Authority and a scholarship from OARSI. Another study investigator, Dr. Martin Englund, disclosed that he received funding support from Swedish Research Council and Lund (Sweden) University, Sweden.

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Hand osteoarthritis becomes more prevalent with advancing age and is more common in women than men, but not in all joint areas, results from a long-term analysis demonstrated.

Over 9 years of follow-up, more men than women developed metacarpal and wrist osteoarthritis (OA), yet more women than men developed erosive and symptomatic OA, according to a report by researchers led by Dr. Ida K. Haugen of the department of rheumatology at Diakonhjemmet Hospital, Oslo, that was published in the September 2011 edition of the Annals of the Rheumatic Diseases.

In what they describe as the first study of its kind, the researchers analyzed data from 2,300 adults who participated in the Framingham OA Study to determine the prevalence and course of radiographic, erosive, and symptomatic hand OA in the general population. All study participants had bilateral hand radiographs at baseline and at 9-year follow-up (Ann. Rheum. Dis. 2011;70:1581-6).

Dr. Ida Haugen and her associates defined radiographic hand OA at the joint level as a Kellgren-Lawrence scale grade 2 or greater, erosive hand OA as a Kellgren-Lawrence grade 2 or greater plus erosion, and symptomatic hand OA as a Kellgren-Lawrence grade 2 or greater plus pain/aching/stiffness. Study participants with one or more affected joint were classified as having hand OA.

The mean age of the study participants was 59 years, 57% were women, and 96% were white. The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Over the 9 years of follow-up, the crude incidence was similar between women and men (35% vs. 34%, respectively), whereas 96% of women and 91% of men who had hand OA at baseline showed progression during follow-up.

The researchers also reported that metacarpophalangeal and wrist OA occurred more frequently and from a younger age in men, compared with women, and that development of erosive disease occurred more frequently in women, compared with men (17% vs. 10%, respectively).

"Consistent with previous studies, we found no clear evidence of higher hand OA incidence in the right hand (usually dominant)," the researchers wrote. "The symmetrical joint affection indicates that ‘wear and tear’ alone is not sufficient to explain the pattern of hand OA, and neurogenic and hormonal influences have been suggested."

They acknowledged certain limitations of the study, including the fact that participants were from a limited geographic area, which makes it "uncertain whether the results can be generalized to larger geographical areas or [nonwhite] groups," they wrote. "The offspring cohort [of the Framingham OA Study] was not randomly selected from the population. However, the participants were not chosen based on joint symptoms, and previous studies have indicated that the cohort is reasonably representative of the US population. The mean time of follow-up was 9 years, and almost all participants showed progression, making discrimination between groups difficult. It is possible but unproven that reading of radiographs in known time sequence may lead to overestimation of progression."

The Framingham Osteoarthritis Study is supported by the National Institutes of Health. Dr. Haugen disclosed that she received grants from the South-Eastern Norway Regional Health Authority and a scholarship from OARSI. Another study investigator, Dr. Martin Englund, disclosed that he received funding support from Swedish Research Council and Lund (Sweden) University, Sweden.

Hand osteoarthritis becomes more prevalent with advancing age and is more common in women than men, but not in all joint areas, results from a long-term analysis demonstrated.

Over 9 years of follow-up, more men than women developed metacarpal and wrist osteoarthritis (OA), yet more women than men developed erosive and symptomatic OA, according to a report by researchers led by Dr. Ida K. Haugen of the department of rheumatology at Diakonhjemmet Hospital, Oslo, that was published in the September 2011 edition of the Annals of the Rheumatic Diseases.

In what they describe as the first study of its kind, the researchers analyzed data from 2,300 adults who participated in the Framingham OA Study to determine the prevalence and course of radiographic, erosive, and symptomatic hand OA in the general population. All study participants had bilateral hand radiographs at baseline and at 9-year follow-up (Ann. Rheum. Dis. 2011;70:1581-6).

Dr. Ida Haugen and her associates defined radiographic hand OA at the joint level as a Kellgren-Lawrence scale grade 2 or greater, erosive hand OA as a Kellgren-Lawrence grade 2 or greater plus erosion, and symptomatic hand OA as a Kellgren-Lawrence grade 2 or greater plus pain/aching/stiffness. Study participants with one or more affected joint were classified as having hand OA.

The mean age of the study participants was 59 years, 57% were women, and 96% were white. The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Over the 9 years of follow-up, the crude incidence was similar between women and men (35% vs. 34%, respectively), whereas 96% of women and 91% of men who had hand OA at baseline showed progression during follow-up.

The researchers also reported that metacarpophalangeal and wrist OA occurred more frequently and from a younger age in men, compared with women, and that development of erosive disease occurred more frequently in women, compared with men (17% vs. 10%, respectively).

"Consistent with previous studies, we found no clear evidence of higher hand OA incidence in the right hand (usually dominant)," the researchers wrote. "The symmetrical joint affection indicates that ‘wear and tear’ alone is not sufficient to explain the pattern of hand OA, and neurogenic and hormonal influences have been suggested."

They acknowledged certain limitations of the study, including the fact that participants were from a limited geographic area, which makes it "uncertain whether the results can be generalized to larger geographical areas or [nonwhite] groups," they wrote. "The offspring cohort [of the Framingham OA Study] was not randomly selected from the population. However, the participants were not chosen based on joint symptoms, and previous studies have indicated that the cohort is reasonably representative of the US population. The mean time of follow-up was 9 years, and almost all participants showed progression, making discrimination between groups difficult. It is possible but unproven that reading of radiographs in known time sequence may lead to overestimation of progression."

The Framingham Osteoarthritis Study is supported by the National Institutes of Health. Dr. Haugen disclosed that she received grants from the South-Eastern Norway Regional Health Authority and a scholarship from OARSI. Another study investigator, Dr. Martin Englund, disclosed that he received funding support from Swedish Research Council and Lund (Sweden) University, Sweden.

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FROM THE ANNALS OF THE RHEUMATIC DISEASES

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Major Finding: The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Data Source: An analysis of 2,300 adults from the ongoing Framingham Osteoarthritis Study who had bilateral hand radiographs at baseline and at 9-year follow-up.

Disclosures: The Framingham OA Study is supported by the National Institutes of Health. Dr. Haugen disclosed that she received grants from the South-Eastern Norway Regional Health Authority and a scholarship from OARSI. Another study investigator, Dr. Martin Englund, disclosed that he received funding support from Swedish Research Council and Lund (Sweden) University.

Study Questions Combining Analgesics for Knee Pain

Findings Suggest New Therapeutic Recommendations
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Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief in adults with knee pain/osteoarthritis. But this gain came at the expense of an increase in presumed gastrointestinal bleeding, results from a large randomized, controlled trial demonstrated.

The trial, published in the September 2011 edition of the Annals of Rheumatic Diseases, found that paracetamol 3 g/day may cause similar levels of blood loss as ibuprofen 1,200 mg/day, and that the combination of the two appears to be additive or even synergistic in terms of the number of individuals with a decrease in hemoglobin greater than 2 g/dL.

"These results need to be confirmed, along with their clinical relevance and identification of the site of gastrointestinal bleeding," wrote the researchers, who were led by Dr. Michael Doherty of the Arthritis UK Pain Center at Nottingham (England) City Hospital. "If confirmed, this observation should lead to the reconsideration of current recommendations for oral analgesic use in osteoarthritis and in chronic pain in general, and to the consideration of strategies to reduce this side effect."

Over a period of 13 weeks, Dr. Doherty and his associates followed 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day: ibuprofen (400 mg), paracetamol (1,000 mg), one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg), or two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1,000 mg).

The primary short-term efficacy end point was the difference at 10 days between groups in the WOMAC (Western Ontario McMaster Universities) osteoarthritis index pain subscale, which was normalized to a 0- to 100-mm scale.

The primary long-term efficacy end point was the patient global assessment of study medication after 13 weeks. This was determined by asking patients, "Taking into account both how your medicine worked for you and any side effects you think it caused you, how would you rate your medication as a treatment for your painful knee?" Respondents used a 5-point scale for replies (1, excellent; 2, good; 3, fair; 4, poor; 5, unacceptable).

The primary safety end point was the incidence of moderate and severe adverse events reported during the study period (Ann. Rheum. Dis. 2011;70:1534-41).

Criteria for inclusion were age of at least 40 years; knee pain for most of the past 3 months and on 4 of 7 preceding days; discontinuation of current analgesics; Steinbrocker functional capacity class I-III; and pain affecting the index knee (after a washout period if currently taking analgesics) of 30 mm or greater and 80 mm or less on a 100-mm visual analog scale over the previous 48 hours for one or more of the following: walking on a flat surface, going up/down stairs, at night, sitting, lying, or standing upright.

The mean age of patients was 61 years, and 51% were men. More than half of the study participants (63%) had radiographic osteoarthritis, and 85% fulfilled American College of Rheumatology criteria for the condition.

The Effects of Combination Tablets

After measuring the mean change in WOMAC pain scores from baseline, the researchers found that at day 10, two combination tablets provided significantly more pain relief, compared with paracetamol alone (P less than .01). At 13 weeks, a significantly greater proportion of participants taking one or two combination tablets rated their treatment as excellent/good, compared with paracetamol alone (P = .015 and .0002, respectively).

The incidence of adverse events was comparable among groups and consisted mainly of dyspepsia, diarrhea, and nausea. However, at 13 weeks a decrease in hemoglobin level by at least 1g/dL was observed among some participants in all treatment groups. More than two-thirds of patients taking two combination tablets experienced this decrease (38%), compared with 24% taking one combination tablet, 20% taking paracetamol monotherapy, and 20% taking ibuprofen monotherapy.

At 13 weeks, a significantly greater proportion of patients in the two combination tablet group experienced a decrease in hemoglobin level by 2 g/L or greater (6.9%), compared with their counterparts in the one combination tablet (1.8%), paracetamol (0.9%), and ibuprofen (0.9%) treatment groups.

Dr. Doherty and his associates acknowledged certain limitations of the study, including the fact that it lacked a placebo arm, "but withholding analgesia for a chronic painful condition raises ethical concerns," they wrote. "Other caveats included the fact that the study was not sufficiently powered to show benefit of the combination tablet over ibuprofen monotherapy, and the WOMAC scale (designed for osteoarthritis rather than knee pain) was used to determine efficacy. However, most participants fulfilled the criteria for osteoarthritis, and pain, stiffness and restricted activity are important patient-centered domains irrespective of confirmed osteoarthritis."

 

 

The study was sponsored by Reckitt Benckiser Healthcare International Ltd. Dr. Doherty disclosed that he has received honoraria for attending two advisory boards for Reckitt Benckiser. In addition, one of the study authors is currently employed by the company and two others are former employees.

Body

This cautious and excellent long-term study reveals many new and important findings that should be the basis for reconsidering treatment of musculoskeletal conditions with OTC analgesics. It may turn out that many of our widely held beliefs are wrong and that recommendations for our patients need to be changed.

The results indicate that we should reconsider the use of a combination of analgesics and also the use of paracetamol alone, as it is not sufficiently effective yet causes many unwanted effects including dyspepsia, diarrhea, and GI blood loss. In line with this notion, studies published during the past few years have shown that paracetamol increases blood pressure when taken for short or prolonged periods and augments the risk of major cardiovascular events when administered at high frequency or dose.

Moreover, there is no mechanistic justification for the combination of paracetamol with another cyclooxygenase-2 inhibitor: The enzyme responsible for the formation of algesic prostaglandin E2 can only be blocked once. Two blockers cannot achieve more effects than one blocker! The analgesic action increases only marginally (if at all), but the unwanted drug effects increase substantially.

On the basis of this study, one wonders why combinations of analgesics of the type described and investigated here should remain on the OTC market. Obviously, there is no scientific evidence that either claim (higher efficacy and/or less toxicity) can be substantiated; rather, the contrary is true.

Kay Brune, M.D., is with the department of experimental and clinical pharmacology and toxicology at Friedrich-Alexander-University of Erlangen-Nuremberg (Germany). Burkhard Hinz, Ph.D., is with the Institute of Toxicology and Pharmacology at the University of Rostock (Germany). This was adapted from an editorial that accompanied the study (Ann. Rheum. Dis. 2011;70:1521-2).

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Body

This cautious and excellent long-term study reveals many new and important findings that should be the basis for reconsidering treatment of musculoskeletal conditions with OTC analgesics. It may turn out that many of our widely held beliefs are wrong and that recommendations for our patients need to be changed.

The results indicate that we should reconsider the use of a combination of analgesics and also the use of paracetamol alone, as it is not sufficiently effective yet causes many unwanted effects including dyspepsia, diarrhea, and GI blood loss. In line with this notion, studies published during the past few years have shown that paracetamol increases blood pressure when taken for short or prolonged periods and augments the risk of major cardiovascular events when administered at high frequency or dose.

Moreover, there is no mechanistic justification for the combination of paracetamol with another cyclooxygenase-2 inhibitor: The enzyme responsible for the formation of algesic prostaglandin E2 can only be blocked once. Two blockers cannot achieve more effects than one blocker! The analgesic action increases only marginally (if at all), but the unwanted drug effects increase substantially.

On the basis of this study, one wonders why combinations of analgesics of the type described and investigated here should remain on the OTC market. Obviously, there is no scientific evidence that either claim (higher efficacy and/or less toxicity) can be substantiated; rather, the contrary is true.

Kay Brune, M.D., is with the department of experimental and clinical pharmacology and toxicology at Friedrich-Alexander-University of Erlangen-Nuremberg (Germany). Burkhard Hinz, Ph.D., is with the Institute of Toxicology and Pharmacology at the University of Rostock (Germany). This was adapted from an editorial that accompanied the study (Ann. Rheum. Dis. 2011;70:1521-2).

Body

This cautious and excellent long-term study reveals many new and important findings that should be the basis for reconsidering treatment of musculoskeletal conditions with OTC analgesics. It may turn out that many of our widely held beliefs are wrong and that recommendations for our patients need to be changed.

The results indicate that we should reconsider the use of a combination of analgesics and also the use of paracetamol alone, as it is not sufficiently effective yet causes many unwanted effects including dyspepsia, diarrhea, and GI blood loss. In line with this notion, studies published during the past few years have shown that paracetamol increases blood pressure when taken for short or prolonged periods and augments the risk of major cardiovascular events when administered at high frequency or dose.

Moreover, there is no mechanistic justification for the combination of paracetamol with another cyclooxygenase-2 inhibitor: The enzyme responsible for the formation of algesic prostaglandin E2 can only be blocked once. Two blockers cannot achieve more effects than one blocker! The analgesic action increases only marginally (if at all), but the unwanted drug effects increase substantially.

On the basis of this study, one wonders why combinations of analgesics of the type described and investigated here should remain on the OTC market. Obviously, there is no scientific evidence that either claim (higher efficacy and/or less toxicity) can be substantiated; rather, the contrary is true.

Kay Brune, M.D., is with the department of experimental and clinical pharmacology and toxicology at Friedrich-Alexander-University of Erlangen-Nuremberg (Germany). Burkhard Hinz, Ph.D., is with the Institute of Toxicology and Pharmacology at the University of Rostock (Germany). This was adapted from an editorial that accompanied the study (Ann. Rheum. Dis. 2011;70:1521-2).

Title
Findings Suggest New Therapeutic Recommendations
Findings Suggest New Therapeutic Recommendations

Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief in adults with knee pain/osteoarthritis. But this gain came at the expense of an increase in presumed gastrointestinal bleeding, results from a large randomized, controlled trial demonstrated.

The trial, published in the September 2011 edition of the Annals of Rheumatic Diseases, found that paracetamol 3 g/day may cause similar levels of blood loss as ibuprofen 1,200 mg/day, and that the combination of the two appears to be additive or even synergistic in terms of the number of individuals with a decrease in hemoglobin greater than 2 g/dL.

"These results need to be confirmed, along with their clinical relevance and identification of the site of gastrointestinal bleeding," wrote the researchers, who were led by Dr. Michael Doherty of the Arthritis UK Pain Center at Nottingham (England) City Hospital. "If confirmed, this observation should lead to the reconsideration of current recommendations for oral analgesic use in osteoarthritis and in chronic pain in general, and to the consideration of strategies to reduce this side effect."

Over a period of 13 weeks, Dr. Doherty and his associates followed 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day: ibuprofen (400 mg), paracetamol (1,000 mg), one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg), or two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1,000 mg).

The primary short-term efficacy end point was the difference at 10 days between groups in the WOMAC (Western Ontario McMaster Universities) osteoarthritis index pain subscale, which was normalized to a 0- to 100-mm scale.

The primary long-term efficacy end point was the patient global assessment of study medication after 13 weeks. This was determined by asking patients, "Taking into account both how your medicine worked for you and any side effects you think it caused you, how would you rate your medication as a treatment for your painful knee?" Respondents used a 5-point scale for replies (1, excellent; 2, good; 3, fair; 4, poor; 5, unacceptable).

The primary safety end point was the incidence of moderate and severe adverse events reported during the study period (Ann. Rheum. Dis. 2011;70:1534-41).

Criteria for inclusion were age of at least 40 years; knee pain for most of the past 3 months and on 4 of 7 preceding days; discontinuation of current analgesics; Steinbrocker functional capacity class I-III; and pain affecting the index knee (after a washout period if currently taking analgesics) of 30 mm or greater and 80 mm or less on a 100-mm visual analog scale over the previous 48 hours for one or more of the following: walking on a flat surface, going up/down stairs, at night, sitting, lying, or standing upright.

The mean age of patients was 61 years, and 51% were men. More than half of the study participants (63%) had radiographic osteoarthritis, and 85% fulfilled American College of Rheumatology criteria for the condition.

The Effects of Combination Tablets

After measuring the mean change in WOMAC pain scores from baseline, the researchers found that at day 10, two combination tablets provided significantly more pain relief, compared with paracetamol alone (P less than .01). At 13 weeks, a significantly greater proportion of participants taking one or two combination tablets rated their treatment as excellent/good, compared with paracetamol alone (P = .015 and .0002, respectively).

The incidence of adverse events was comparable among groups and consisted mainly of dyspepsia, diarrhea, and nausea. However, at 13 weeks a decrease in hemoglobin level by at least 1g/dL was observed among some participants in all treatment groups. More than two-thirds of patients taking two combination tablets experienced this decrease (38%), compared with 24% taking one combination tablet, 20% taking paracetamol monotherapy, and 20% taking ibuprofen monotherapy.

At 13 weeks, a significantly greater proportion of patients in the two combination tablet group experienced a decrease in hemoglobin level by 2 g/L or greater (6.9%), compared with their counterparts in the one combination tablet (1.8%), paracetamol (0.9%), and ibuprofen (0.9%) treatment groups.

Dr. Doherty and his associates acknowledged certain limitations of the study, including the fact that it lacked a placebo arm, "but withholding analgesia for a chronic painful condition raises ethical concerns," they wrote. "Other caveats included the fact that the study was not sufficiently powered to show benefit of the combination tablet over ibuprofen monotherapy, and the WOMAC scale (designed for osteoarthritis rather than knee pain) was used to determine efficacy. However, most participants fulfilled the criteria for osteoarthritis, and pain, stiffness and restricted activity are important patient-centered domains irrespective of confirmed osteoarthritis."

 

 

The study was sponsored by Reckitt Benckiser Healthcare International Ltd. Dr. Doherty disclosed that he has received honoraria for attending two advisory boards for Reckitt Benckiser. In addition, one of the study authors is currently employed by the company and two others are former employees.

Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief in adults with knee pain/osteoarthritis. But this gain came at the expense of an increase in presumed gastrointestinal bleeding, results from a large randomized, controlled trial demonstrated.

The trial, published in the September 2011 edition of the Annals of Rheumatic Diseases, found that paracetamol 3 g/day may cause similar levels of blood loss as ibuprofen 1,200 mg/day, and that the combination of the two appears to be additive or even synergistic in terms of the number of individuals with a decrease in hemoglobin greater than 2 g/dL.

"These results need to be confirmed, along with their clinical relevance and identification of the site of gastrointestinal bleeding," wrote the researchers, who were led by Dr. Michael Doherty of the Arthritis UK Pain Center at Nottingham (England) City Hospital. "If confirmed, this observation should lead to the reconsideration of current recommendations for oral analgesic use in osteoarthritis and in chronic pain in general, and to the consideration of strategies to reduce this side effect."

Over a period of 13 weeks, Dr. Doherty and his associates followed 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day: ibuprofen (400 mg), paracetamol (1,000 mg), one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg), or two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1,000 mg).

The primary short-term efficacy end point was the difference at 10 days between groups in the WOMAC (Western Ontario McMaster Universities) osteoarthritis index pain subscale, which was normalized to a 0- to 100-mm scale.

The primary long-term efficacy end point was the patient global assessment of study medication after 13 weeks. This was determined by asking patients, "Taking into account both how your medicine worked for you and any side effects you think it caused you, how would you rate your medication as a treatment for your painful knee?" Respondents used a 5-point scale for replies (1, excellent; 2, good; 3, fair; 4, poor; 5, unacceptable).

The primary safety end point was the incidence of moderate and severe adverse events reported during the study period (Ann. Rheum. Dis. 2011;70:1534-41).

Criteria for inclusion were age of at least 40 years; knee pain for most of the past 3 months and on 4 of 7 preceding days; discontinuation of current analgesics; Steinbrocker functional capacity class I-III; and pain affecting the index knee (after a washout period if currently taking analgesics) of 30 mm or greater and 80 mm or less on a 100-mm visual analog scale over the previous 48 hours for one or more of the following: walking on a flat surface, going up/down stairs, at night, sitting, lying, or standing upright.

The mean age of patients was 61 years, and 51% were men. More than half of the study participants (63%) had radiographic osteoarthritis, and 85% fulfilled American College of Rheumatology criteria for the condition.

The Effects of Combination Tablets

After measuring the mean change in WOMAC pain scores from baseline, the researchers found that at day 10, two combination tablets provided significantly more pain relief, compared with paracetamol alone (P less than .01). At 13 weeks, a significantly greater proportion of participants taking one or two combination tablets rated their treatment as excellent/good, compared with paracetamol alone (P = .015 and .0002, respectively).

The incidence of adverse events was comparable among groups and consisted mainly of dyspepsia, diarrhea, and nausea. However, at 13 weeks a decrease in hemoglobin level by at least 1g/dL was observed among some participants in all treatment groups. More than two-thirds of patients taking two combination tablets experienced this decrease (38%), compared with 24% taking one combination tablet, 20% taking paracetamol monotherapy, and 20% taking ibuprofen monotherapy.

At 13 weeks, a significantly greater proportion of patients in the two combination tablet group experienced a decrease in hemoglobin level by 2 g/L or greater (6.9%), compared with their counterparts in the one combination tablet (1.8%), paracetamol (0.9%), and ibuprofen (0.9%) treatment groups.

Dr. Doherty and his associates acknowledged certain limitations of the study, including the fact that it lacked a placebo arm, "but withholding analgesia for a chronic painful condition raises ethical concerns," they wrote. "Other caveats included the fact that the study was not sufficiently powered to show benefit of the combination tablet over ibuprofen monotherapy, and the WOMAC scale (designed for osteoarthritis rather than knee pain) was used to determine efficacy. However, most participants fulfilled the criteria for osteoarthritis, and pain, stiffness and restricted activity are important patient-centered domains irrespective of confirmed osteoarthritis."

 

 

The study was sponsored by Reckitt Benckiser Healthcare International Ltd. Dr. Doherty disclosed that he has received honoraria for attending two advisory boards for Reckitt Benckiser. In addition, one of the study authors is currently employed by the company and two others are former employees.

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FROM THE ANNALS OF RHEUMATIC DISEASES

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Major Finding: Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief after 10 days in adults with knee pain/osteoarthritis (P less than .01), but at the expense of an increase in presumed GI bleeding at 13 weeks.

Data Source: A study of 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day.

Disclosures: The study was sponsored by Reckitt Benckiser Healthcare International Ltd. Dr. Doherty disclosed that he has received honoraria for attending two advisory boards for Reckitt Benckiser. In addition, one of the study authors is currently employed by the company and two others are former employees.

Should Anticoagulation Treatment Be Stopped Before Surgery?

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Should Anticoagulation Treatment Be Stopped Before Surgery?

SAN DIEGO – Whether to stop anticoagulation therapy before dermatologic surgery can be a tricky call, said Dr. Tissa Hata.

Based on the serious nature of thrombotic complications and low risk of serious hemorrhagic complications, most clinicians would agree that patients on warfarin "should have therapy continued throughout the procedure and the INR [international normalized ratio] should be within the accepted therapeutic range – usually less than 3.0," Dr. Hata said at a meeting on superficial anatomy and cutaneous surgery, sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic.

Patients on aspirin, if medically necessary, "should be continued," advised Dr. Hata, professor of dermatology at the University of California, San Diego. "If aspirin is not medically necessary, the surgeon may choose to continue to discontinue. Always involve the prescribing physician in any decision to discontinue any of the medications."

She based her remarks in part on results from a prospective study of 5,950 skin cancer lesions excised in 2,394 patients (Br. J. Surg. 2007;94:1356-60). The rate of postoperative bleeding was 0.7% overall and 2.5% among the 320 patients who were taking warfarin.

The rate of bleeding was 1.0% for skin flap repairs, 0.4% for simple excision and closure, and 5.0% for skin grafts. Of the 40 cases of bleeding in the study, 26 were hemorrhages and 14 were hematomas. Three patients (two of whom were on warfarin) required exploration and one had vessel ligation. Two patients (neither of whom were on warfarin) had hematoma evacuation.

The following factors were associated with a significantly increased risk of bleeding: age greater than 67 years (odds ratio 4.7), being on warfarin therapy (OR 2.9), having undergone flap or graft surgery (OR 2.7), and having undergone ear surgery (OR 2.6).

A more recent meta-analysis representing 1,373 patients undergoing dermatologic surgery who were taking anticoagulant medications prior to surgery found that patients taking warfarin were nearly seven times more likely to have a moderate to severe complication, compared with controls (Dermatol. Surg. 2008;34:160-5). Patients taking aspirin were nearly twice as likely to have a moderate to severe complication, compared with controls.

"It does appear that warfarin and aspirin do increase your risk of bleeding and complications," Dr. Hata said. "What does that mean for us? Should we stop all of our aspirin and anticoagulants prior to procedures? What’s the risk of thrombotic complications when we stop their therapy?"

A review of studies associated with preoperative warfarin discontinuation found that the rates of thromboembolism range from 5.8%-47% within 1 month of stopping warfarin, while the yearly incidence of thromboembolism for patients with nonvalvular atrial fibrillation is 4.5% and 8% for patients with a mechanical heart valve (Dermatol. Surg. 2000;26:785-9).

According to a survey of 271 members of the American College of Mohs Micrographic Surgery and Cutaneous Oncology, 126 complications were associated with discontinuing warfarin and aspirin, most notably stroke (39 cases), transient ischemic attack (25 cases), and myocardial infarction (19 cases). More than half of respondents (56%) said that they never stop warfarin therapy prior to surgery, 41% sometimes do, and 3% always do (Dermatol. Surg. 2007;33:1189-97). In addition, 63% said that they never discontinue medically necessary aspirin prior to surgery, 34% sometimes do, and 3% always do.

Dr. Hata said that she had no relevant financial conflicts to disclose.

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SAN DIEGO – Whether to stop anticoagulation therapy before dermatologic surgery can be a tricky call, said Dr. Tissa Hata.

Based on the serious nature of thrombotic complications and low risk of serious hemorrhagic complications, most clinicians would agree that patients on warfarin "should have therapy continued throughout the procedure and the INR [international normalized ratio] should be within the accepted therapeutic range – usually less than 3.0," Dr. Hata said at a meeting on superficial anatomy and cutaneous surgery, sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic.

Patients on aspirin, if medically necessary, "should be continued," advised Dr. Hata, professor of dermatology at the University of California, San Diego. "If aspirin is not medically necessary, the surgeon may choose to continue to discontinue. Always involve the prescribing physician in any decision to discontinue any of the medications."

She based her remarks in part on results from a prospective study of 5,950 skin cancer lesions excised in 2,394 patients (Br. J. Surg. 2007;94:1356-60). The rate of postoperative bleeding was 0.7% overall and 2.5% among the 320 patients who were taking warfarin.

The rate of bleeding was 1.0% for skin flap repairs, 0.4% for simple excision and closure, and 5.0% for skin grafts. Of the 40 cases of bleeding in the study, 26 were hemorrhages and 14 were hematomas. Three patients (two of whom were on warfarin) required exploration and one had vessel ligation. Two patients (neither of whom were on warfarin) had hematoma evacuation.

The following factors were associated with a significantly increased risk of bleeding: age greater than 67 years (odds ratio 4.7), being on warfarin therapy (OR 2.9), having undergone flap or graft surgery (OR 2.7), and having undergone ear surgery (OR 2.6).

A more recent meta-analysis representing 1,373 patients undergoing dermatologic surgery who were taking anticoagulant medications prior to surgery found that patients taking warfarin were nearly seven times more likely to have a moderate to severe complication, compared with controls (Dermatol. Surg. 2008;34:160-5). Patients taking aspirin were nearly twice as likely to have a moderate to severe complication, compared with controls.

"It does appear that warfarin and aspirin do increase your risk of bleeding and complications," Dr. Hata said. "What does that mean for us? Should we stop all of our aspirin and anticoagulants prior to procedures? What’s the risk of thrombotic complications when we stop their therapy?"

A review of studies associated with preoperative warfarin discontinuation found that the rates of thromboembolism range from 5.8%-47% within 1 month of stopping warfarin, while the yearly incidence of thromboembolism for patients with nonvalvular atrial fibrillation is 4.5% and 8% for patients with a mechanical heart valve (Dermatol. Surg. 2000;26:785-9).

According to a survey of 271 members of the American College of Mohs Micrographic Surgery and Cutaneous Oncology, 126 complications were associated with discontinuing warfarin and aspirin, most notably stroke (39 cases), transient ischemic attack (25 cases), and myocardial infarction (19 cases). More than half of respondents (56%) said that they never stop warfarin therapy prior to surgery, 41% sometimes do, and 3% always do (Dermatol. Surg. 2007;33:1189-97). In addition, 63% said that they never discontinue medically necessary aspirin prior to surgery, 34% sometimes do, and 3% always do.

Dr. Hata said that she had no relevant financial conflicts to disclose.

SAN DIEGO – Whether to stop anticoagulation therapy before dermatologic surgery can be a tricky call, said Dr. Tissa Hata.

Based on the serious nature of thrombotic complications and low risk of serious hemorrhagic complications, most clinicians would agree that patients on warfarin "should have therapy continued throughout the procedure and the INR [international normalized ratio] should be within the accepted therapeutic range – usually less than 3.0," Dr. Hata said at a meeting on superficial anatomy and cutaneous surgery, sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic.

Patients on aspirin, if medically necessary, "should be continued," advised Dr. Hata, professor of dermatology at the University of California, San Diego. "If aspirin is not medically necessary, the surgeon may choose to continue to discontinue. Always involve the prescribing physician in any decision to discontinue any of the medications."

She based her remarks in part on results from a prospective study of 5,950 skin cancer lesions excised in 2,394 patients (Br. J. Surg. 2007;94:1356-60). The rate of postoperative bleeding was 0.7% overall and 2.5% among the 320 patients who were taking warfarin.

The rate of bleeding was 1.0% for skin flap repairs, 0.4% for simple excision and closure, and 5.0% for skin grafts. Of the 40 cases of bleeding in the study, 26 were hemorrhages and 14 were hematomas. Three patients (two of whom were on warfarin) required exploration and one had vessel ligation. Two patients (neither of whom were on warfarin) had hematoma evacuation.

The following factors were associated with a significantly increased risk of bleeding: age greater than 67 years (odds ratio 4.7), being on warfarin therapy (OR 2.9), having undergone flap or graft surgery (OR 2.7), and having undergone ear surgery (OR 2.6).

A more recent meta-analysis representing 1,373 patients undergoing dermatologic surgery who were taking anticoagulant medications prior to surgery found that patients taking warfarin were nearly seven times more likely to have a moderate to severe complication, compared with controls (Dermatol. Surg. 2008;34:160-5). Patients taking aspirin were nearly twice as likely to have a moderate to severe complication, compared with controls.

"It does appear that warfarin and aspirin do increase your risk of bleeding and complications," Dr. Hata said. "What does that mean for us? Should we stop all of our aspirin and anticoagulants prior to procedures? What’s the risk of thrombotic complications when we stop their therapy?"

A review of studies associated with preoperative warfarin discontinuation found that the rates of thromboembolism range from 5.8%-47% within 1 month of stopping warfarin, while the yearly incidence of thromboembolism for patients with nonvalvular atrial fibrillation is 4.5% and 8% for patients with a mechanical heart valve (Dermatol. Surg. 2000;26:785-9).

According to a survey of 271 members of the American College of Mohs Micrographic Surgery and Cutaneous Oncology, 126 complications were associated with discontinuing warfarin and aspirin, most notably stroke (39 cases), transient ischemic attack (25 cases), and myocardial infarction (19 cases). More than half of respondents (56%) said that they never stop warfarin therapy prior to surgery, 41% sometimes do, and 3% always do (Dermatol. Surg. 2007;33:1189-97). In addition, 63% said that they never discontinue medically necessary aspirin prior to surgery, 34% sometimes do, and 3% always do.

Dr. Hata said that she had no relevant financial conflicts to disclose.

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EXPERT ANALYSIS FROM A MEETING ON SUPERFICIAL ANATOMY AND CUTANEOUS SURGERY

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Consider Marking Facial Lines Before Challenging Repairs

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SAN DIEGO – A chief goal during cutaneous surgery in the facial region should be to avoid disturbing or crossing contour lines such as the alar fold, the junction of the eyebrow and forehead, and the eyelid margin, according to Dr. Jenny Kim.

"Alterations in these aesthetic lines will have a profound impact on an individual’s appearance," Dr. Kim said at the meeting sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic. "Functional complications may also result from crossing these lines."

If the defect involves one or more cosmetic units, such as the cheek and nose, "repair each unit separately," advised Dr. Kim, associate professor of medicine and dermatology at the University of California, Los Angeles. "This allows for incisions to be hidden along contour lines and will provide you with a better aesthetic appearance."

She also recommends marking contour lines prior to challenging repairs, such as those in the vermilion border of the lip or in the nasolabial fold.

Skin tension lines, she said, follow the direction of the greatest intrinsic tension in the skin. Also known as maximal skin tension lines, relaxed skin tension lines, and Langer’s lines, skin tension lines "are less well defined compared with contour lines, and incisions placed parallel to these lines heal with a finer, more cosmetically pleasing scar," Dr. Kim said.

Unlike contour lines, skin tension lines vary widely among individuals due to various intrinsic and extrinsic factors "One of the most important intrinsic factors is the collagen in our dermis," she said. "Type I and type III collagen provide 70%-80% of wound volume in the dermis as well as tensile properties of the skin. It resists extensibility under tension and elongates with prolonged tension."

On the other hand, she continued, elastic tissue "will easily be extensible under minimal tension. It has the capacity to resume its original shape after tension is released. Elastic fibers maintain static tension of the skin and provide tensile strength."

Elastic tissue has an increased tension vector parallel to skin tension lines and a decreased tension vector perpendicular to skin tension lines. "These are some of the reasons why you want your wound to be parallel to your skin tension lines," said Dr. Kim, who is also a codirector of the medical school’s Procedural Dermatology Fellowship.

Extrinsic factors that play a role in skin tension lines include the muscles of facial expression, sun damage, aging, and smoking. Aging, for example, leads to fragmentation and loss of elastic fiber, "which is why there’s more variability in skin tension lines as you age," she said.

In order to best determine skin tension lines prior to surgery, have the patient sit upright. "This is because the lines can appear different when a person is lying down versus sitting due to gravity," Dr. Kim said. "Creases and folds secondary to muscle movement can be determined by having patients move facial muscles."

She makes it a point to mark skin tension lines before using anesthesia, "as the swelling from anesthesia makes these lines visible and a patient may not be able to contract muscles later. Draw in the skin tension lines before beginning the surgery. You want to make sure that you maintain function [of the lines], especially around the eyes and the mouth. Evaluate each patient individually, because there are always exceptions to our rules."

Dr. Kim said that she had no relevant financial conflicts to disclose.

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SAN DIEGO – A chief goal during cutaneous surgery in the facial region should be to avoid disturbing or crossing contour lines such as the alar fold, the junction of the eyebrow and forehead, and the eyelid margin, according to Dr. Jenny Kim.

"Alterations in these aesthetic lines will have a profound impact on an individual’s appearance," Dr. Kim said at the meeting sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic. "Functional complications may also result from crossing these lines."

If the defect involves one or more cosmetic units, such as the cheek and nose, "repair each unit separately," advised Dr. Kim, associate professor of medicine and dermatology at the University of California, Los Angeles. "This allows for incisions to be hidden along contour lines and will provide you with a better aesthetic appearance."

She also recommends marking contour lines prior to challenging repairs, such as those in the vermilion border of the lip or in the nasolabial fold.

Skin tension lines, she said, follow the direction of the greatest intrinsic tension in the skin. Also known as maximal skin tension lines, relaxed skin tension lines, and Langer’s lines, skin tension lines "are less well defined compared with contour lines, and incisions placed parallel to these lines heal with a finer, more cosmetically pleasing scar," Dr. Kim said.

Unlike contour lines, skin tension lines vary widely among individuals due to various intrinsic and extrinsic factors "One of the most important intrinsic factors is the collagen in our dermis," she said. "Type I and type III collagen provide 70%-80% of wound volume in the dermis as well as tensile properties of the skin. It resists extensibility under tension and elongates with prolonged tension."

On the other hand, she continued, elastic tissue "will easily be extensible under minimal tension. It has the capacity to resume its original shape after tension is released. Elastic fibers maintain static tension of the skin and provide tensile strength."

Elastic tissue has an increased tension vector parallel to skin tension lines and a decreased tension vector perpendicular to skin tension lines. "These are some of the reasons why you want your wound to be parallel to your skin tension lines," said Dr. Kim, who is also a codirector of the medical school’s Procedural Dermatology Fellowship.

Extrinsic factors that play a role in skin tension lines include the muscles of facial expression, sun damage, aging, and smoking. Aging, for example, leads to fragmentation and loss of elastic fiber, "which is why there’s more variability in skin tension lines as you age," she said.

In order to best determine skin tension lines prior to surgery, have the patient sit upright. "This is because the lines can appear different when a person is lying down versus sitting due to gravity," Dr. Kim said. "Creases and folds secondary to muscle movement can be determined by having patients move facial muscles."

She makes it a point to mark skin tension lines before using anesthesia, "as the swelling from anesthesia makes these lines visible and a patient may not be able to contract muscles later. Draw in the skin tension lines before beginning the surgery. You want to make sure that you maintain function [of the lines], especially around the eyes and the mouth. Evaluate each patient individually, because there are always exceptions to our rules."

Dr. Kim said that she had no relevant financial conflicts to disclose.

SAN DIEGO – A chief goal during cutaneous surgery in the facial region should be to avoid disturbing or crossing contour lines such as the alar fold, the junction of the eyebrow and forehead, and the eyelid margin, according to Dr. Jenny Kim.

"Alterations in these aesthetic lines will have a profound impact on an individual’s appearance," Dr. Kim said at the meeting sponsored by the University of California, San Diego School of Medicine and the Scripps Clinic. "Functional complications may also result from crossing these lines."

If the defect involves one or more cosmetic units, such as the cheek and nose, "repair each unit separately," advised Dr. Kim, associate professor of medicine and dermatology at the University of California, Los Angeles. "This allows for incisions to be hidden along contour lines and will provide you with a better aesthetic appearance."

She also recommends marking contour lines prior to challenging repairs, such as those in the vermilion border of the lip or in the nasolabial fold.

Skin tension lines, she said, follow the direction of the greatest intrinsic tension in the skin. Also known as maximal skin tension lines, relaxed skin tension lines, and Langer’s lines, skin tension lines "are less well defined compared with contour lines, and incisions placed parallel to these lines heal with a finer, more cosmetically pleasing scar," Dr. Kim said.

Unlike contour lines, skin tension lines vary widely among individuals due to various intrinsic and extrinsic factors "One of the most important intrinsic factors is the collagen in our dermis," she said. "Type I and type III collagen provide 70%-80% of wound volume in the dermis as well as tensile properties of the skin. It resists extensibility under tension and elongates with prolonged tension."

On the other hand, she continued, elastic tissue "will easily be extensible under minimal tension. It has the capacity to resume its original shape after tension is released. Elastic fibers maintain static tension of the skin and provide tensile strength."

Elastic tissue has an increased tension vector parallel to skin tension lines and a decreased tension vector perpendicular to skin tension lines. "These are some of the reasons why you want your wound to be parallel to your skin tension lines," said Dr. Kim, who is also a codirector of the medical school’s Procedural Dermatology Fellowship.

Extrinsic factors that play a role in skin tension lines include the muscles of facial expression, sun damage, aging, and smoking. Aging, for example, leads to fragmentation and loss of elastic fiber, "which is why there’s more variability in skin tension lines as you age," she said.

In order to best determine skin tension lines prior to surgery, have the patient sit upright. "This is because the lines can appear different when a person is lying down versus sitting due to gravity," Dr. Kim said. "Creases and folds secondary to muscle movement can be determined by having patients move facial muscles."

She makes it a point to mark skin tension lines before using anesthesia, "as the swelling from anesthesia makes these lines visible and a patient may not be able to contract muscles later. Draw in the skin tension lines before beginning the surgery. You want to make sure that you maintain function [of the lines], especially around the eyes and the mouth. Evaluate each patient individually, because there are always exceptions to our rules."

Dr. Kim said that she had no relevant financial conflicts to disclose.

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EXPERT ANALYSIS FROM A MEETING ON SUPERFICIAL ANATOMY AND CUTANEOUS SURGERY

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