Hallucinations Common in Pediatric Lupus

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Major Finding: Hallucinations are a common finding in children with NPSLE.

Data Source: An observational study of 53 children with juvenile SLE with neuropsychiatric manifestations.

Disclosures: Dr. Lim reported no financial conflicts of interest.

MONTREAL — Pediatric neuropsychiatric systemic lupus erythematosus has several unique manifestations that are not seen in adult patients, and without precise questioning they could easily be missed, reported Dr. Lily Siok Hoon Lim.

Patients can have visual, auditory, and even tactile hallucinations, but about 70% of them have “preservation of insight,” meaning they know these experiences are not real, said Dr. Lim, a rheumatologist at the Hospital for Sick Children in Toronto. Because they can distinguish between hallucinations and reality, the children repress their symptoms and do not tell their parents or physicians “because they don't want to be seen as crazy,” she said in an interview.

Visual hallucination and distortion are seen in three-quarters of pediatric patients with neuropsychiatric systemic lupus erythematosus (NPSLE) but have not been documented in adults with NPSLE, Dr. Lim said at the annual meeting of the Canadian Rheumatology Association. “They may be looking at a picture frame on the wall, and it might distort and move in and out at them. We find a lot of patients have had mild symptoms for a long time without reporting them. Also a lot of them see bugs, or spiders crawling towards them, and that is very frightening,” she said.

In an observational study which she presented as a poster at the meeting, Dr. Lim and her colleagues followed a cohort of children with NPSLE at a single center between August 1985 and December 2008. Of a total of 447 children with juvenile SLE, 53 (12%) children and adolescents (46 female) exhibited secondary psychiatric manifestations and cognitive dysfunction. Half of the subjects had psychiatric manifestations at first presentation of JSLE and 77% exhibited them within a year of diagnosis. The median age of diagnosis with psychiatric illness was 15.9 years and the median duration of psychiatric symptoms prior to diagnosis was 60 days.

Clinical and laboratory measures, imaging features, and treatment regimens were collected using standardized assessment forms, and all patients were evaluated by an experienced psychiatrist.

The clinical features of lupus-related psychiatric disease were identified and classified according to American College of Rheumatology nomenclature for adult disease (Arthritis Rheum. 1999;42:599-608), with the exception of cognitive dysfunction. “Cognitive dysfunction is controversial in lupus because if you take a whole population of lupus patients and systematically study them with neurocognitive tests, 60% of them will have something, but it's subclinical; it doesn't affect how they function,” said Dr. Lim.

For this study, the investigators developed a definition of pediatric cognitive dysfunction that included patient- or parent-reported memory or attention deficit affecting academic performance. Specifically, a patient needed to fulfill the following three criteria: self-reported or observed problems with concentration or memory; significant impairment of the patient's academic performance, as indicated by a significant drop in grades; and improvement following treatment.

Using this definition, the study revealed that all patients had significant cognitive dysfunction, said Dr. Lim. “What's special is that our patients had actually reported these problems. For example, their short-term memory was bad; they couldn't remember what they ate for breakfast, or what their homework was. They also couldn't learn new stuff at school, they had word-finding difficulties, and they were also not doing well in school. So you may have had an A student going down to C.”

She said that 85% of the subjects had concentration difficulties, 77% had memory deficits, 23% had psychomotor slowing, and 21% had decreased comprehension. Two patients also had prominent depressive features.

In addition, 75% of the subjects also had psychosis with hallucinations. In 83% the hallucinations were auditory, 75% were visual, and 20% were tactile. Visual distortion also was reported in 38% of this psychosis subset, she said.

In all, 42 of the 53 patients underwent magnetic resonance brain imaging, of whom 45% had normal results, 29% had cerebral atrophy only, and 17% had nonspecific white matter changes only. Of the 53 patients, 28 underwent lumbar puncture, of whom 64% had normal results, 29% had elevated total protein, and 7% had an elevated white cell count.

Prednisone was started in all patients and increased according to standard protocol. In addition, all but three patients required second-line immunosuppressant therapy (85% with azathioprine, 55% with cyclophosphamide, and 28% with mycophenolate).

“What we're finding is that even among second-line immunosuppressants, cyclophosphamide is turning out to be something that is very useful,” commented Dr. Lim. “When we start patients on azathioprine because their symptoms are mainly cognitive, or they have only mild psychotic symptoms, we find that a third actually need to be switched over.” Of the patients with psychosis, 60% (n = 24) also required antipsychotic therapy.

 

 

The investigators were able to collect data on response to therapy for some of the patients: Six relapsed and 25 went on to remission (although 3 of these eventually relapsed).

Response was defined as the absence of psychiatric symptoms, no antipsychotic medication, and prednisone at less than 50% of the peak dose for at least 3 months. Remission was defined as absence of psychiatric symptoms, no antipsychotic medication, prednisone at 10 mg or less a day, or 0.2 mg/kg per day or less for at least 3 months. And relapse was defined as a recurrence of psychiatric symptoms, a requirement of at least a 50% increase in prednisone dose, or a change in second-line immunosuppressive agents (not due to adverse effects), or the addition of antipsychotic medication. There were 14 nonresponders. “The nonresponse may be because they presented in adolescence, and the follow-up was short before they transferred to an adult clinic,” she said.

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Major Finding: Hallucinations are a common finding in children with NPSLE.

Data Source: An observational study of 53 children with juvenile SLE with neuropsychiatric manifestations.

Disclosures: Dr. Lim reported no financial conflicts of interest.

MONTREAL — Pediatric neuropsychiatric systemic lupus erythematosus has several unique manifestations that are not seen in adult patients, and without precise questioning they could easily be missed, reported Dr. Lily Siok Hoon Lim.

Patients can have visual, auditory, and even tactile hallucinations, but about 70% of them have “preservation of insight,” meaning they know these experiences are not real, said Dr. Lim, a rheumatologist at the Hospital for Sick Children in Toronto. Because they can distinguish between hallucinations and reality, the children repress their symptoms and do not tell their parents or physicians “because they don't want to be seen as crazy,” she said in an interview.

Visual hallucination and distortion are seen in three-quarters of pediatric patients with neuropsychiatric systemic lupus erythematosus (NPSLE) but have not been documented in adults with NPSLE, Dr. Lim said at the annual meeting of the Canadian Rheumatology Association. “They may be looking at a picture frame on the wall, and it might distort and move in and out at them. We find a lot of patients have had mild symptoms for a long time without reporting them. Also a lot of them see bugs, or spiders crawling towards them, and that is very frightening,” she said.

In an observational study which she presented as a poster at the meeting, Dr. Lim and her colleagues followed a cohort of children with NPSLE at a single center between August 1985 and December 2008. Of a total of 447 children with juvenile SLE, 53 (12%) children and adolescents (46 female) exhibited secondary psychiatric manifestations and cognitive dysfunction. Half of the subjects had psychiatric manifestations at first presentation of JSLE and 77% exhibited them within a year of diagnosis. The median age of diagnosis with psychiatric illness was 15.9 years and the median duration of psychiatric symptoms prior to diagnosis was 60 days.

Clinical and laboratory measures, imaging features, and treatment regimens were collected using standardized assessment forms, and all patients were evaluated by an experienced psychiatrist.

The clinical features of lupus-related psychiatric disease were identified and classified according to American College of Rheumatology nomenclature for adult disease (Arthritis Rheum. 1999;42:599-608), with the exception of cognitive dysfunction. “Cognitive dysfunction is controversial in lupus because if you take a whole population of lupus patients and systematically study them with neurocognitive tests, 60% of them will have something, but it's subclinical; it doesn't affect how they function,” said Dr. Lim.

For this study, the investigators developed a definition of pediatric cognitive dysfunction that included patient- or parent-reported memory or attention deficit affecting academic performance. Specifically, a patient needed to fulfill the following three criteria: self-reported or observed problems with concentration or memory; significant impairment of the patient's academic performance, as indicated by a significant drop in grades; and improvement following treatment.

Using this definition, the study revealed that all patients had significant cognitive dysfunction, said Dr. Lim. “What's special is that our patients had actually reported these problems. For example, their short-term memory was bad; they couldn't remember what they ate for breakfast, or what their homework was. They also couldn't learn new stuff at school, they had word-finding difficulties, and they were also not doing well in school. So you may have had an A student going down to C.”

She said that 85% of the subjects had concentration difficulties, 77% had memory deficits, 23% had psychomotor slowing, and 21% had decreased comprehension. Two patients also had prominent depressive features.

In addition, 75% of the subjects also had psychosis with hallucinations. In 83% the hallucinations were auditory, 75% were visual, and 20% were tactile. Visual distortion also was reported in 38% of this psychosis subset, she said.

In all, 42 of the 53 patients underwent magnetic resonance brain imaging, of whom 45% had normal results, 29% had cerebral atrophy only, and 17% had nonspecific white matter changes only. Of the 53 patients, 28 underwent lumbar puncture, of whom 64% had normal results, 29% had elevated total protein, and 7% had an elevated white cell count.

Prednisone was started in all patients and increased according to standard protocol. In addition, all but three patients required second-line immunosuppressant therapy (85% with azathioprine, 55% with cyclophosphamide, and 28% with mycophenolate).

“What we're finding is that even among second-line immunosuppressants, cyclophosphamide is turning out to be something that is very useful,” commented Dr. Lim. “When we start patients on azathioprine because their symptoms are mainly cognitive, or they have only mild psychotic symptoms, we find that a third actually need to be switched over.” Of the patients with psychosis, 60% (n = 24) also required antipsychotic therapy.

 

 

The investigators were able to collect data on response to therapy for some of the patients: Six relapsed and 25 went on to remission (although 3 of these eventually relapsed).

Response was defined as the absence of psychiatric symptoms, no antipsychotic medication, and prednisone at less than 50% of the peak dose for at least 3 months. Remission was defined as absence of psychiatric symptoms, no antipsychotic medication, prednisone at 10 mg or less a day, or 0.2 mg/kg per day or less for at least 3 months. And relapse was defined as a recurrence of psychiatric symptoms, a requirement of at least a 50% increase in prednisone dose, or a change in second-line immunosuppressive agents (not due to adverse effects), or the addition of antipsychotic medication. There were 14 nonresponders. “The nonresponse may be because they presented in adolescence, and the follow-up was short before they transferred to an adult clinic,” she said.

Major Finding: Hallucinations are a common finding in children with NPSLE.

Data Source: An observational study of 53 children with juvenile SLE with neuropsychiatric manifestations.

Disclosures: Dr. Lim reported no financial conflicts of interest.

MONTREAL — Pediatric neuropsychiatric systemic lupus erythematosus has several unique manifestations that are not seen in adult patients, and without precise questioning they could easily be missed, reported Dr. Lily Siok Hoon Lim.

Patients can have visual, auditory, and even tactile hallucinations, but about 70% of them have “preservation of insight,” meaning they know these experiences are not real, said Dr. Lim, a rheumatologist at the Hospital for Sick Children in Toronto. Because they can distinguish between hallucinations and reality, the children repress their symptoms and do not tell their parents or physicians “because they don't want to be seen as crazy,” she said in an interview.

Visual hallucination and distortion are seen in three-quarters of pediatric patients with neuropsychiatric systemic lupus erythematosus (NPSLE) but have not been documented in adults with NPSLE, Dr. Lim said at the annual meeting of the Canadian Rheumatology Association. “They may be looking at a picture frame on the wall, and it might distort and move in and out at them. We find a lot of patients have had mild symptoms for a long time without reporting them. Also a lot of them see bugs, or spiders crawling towards them, and that is very frightening,” she said.

In an observational study which she presented as a poster at the meeting, Dr. Lim and her colleagues followed a cohort of children with NPSLE at a single center between August 1985 and December 2008. Of a total of 447 children with juvenile SLE, 53 (12%) children and adolescents (46 female) exhibited secondary psychiatric manifestations and cognitive dysfunction. Half of the subjects had psychiatric manifestations at first presentation of JSLE and 77% exhibited them within a year of diagnosis. The median age of diagnosis with psychiatric illness was 15.9 years and the median duration of psychiatric symptoms prior to diagnosis was 60 days.

Clinical and laboratory measures, imaging features, and treatment regimens were collected using standardized assessment forms, and all patients were evaluated by an experienced psychiatrist.

The clinical features of lupus-related psychiatric disease were identified and classified according to American College of Rheumatology nomenclature for adult disease (Arthritis Rheum. 1999;42:599-608), with the exception of cognitive dysfunction. “Cognitive dysfunction is controversial in lupus because if you take a whole population of lupus patients and systematically study them with neurocognitive tests, 60% of them will have something, but it's subclinical; it doesn't affect how they function,” said Dr. Lim.

For this study, the investigators developed a definition of pediatric cognitive dysfunction that included patient- or parent-reported memory or attention deficit affecting academic performance. Specifically, a patient needed to fulfill the following three criteria: self-reported or observed problems with concentration or memory; significant impairment of the patient's academic performance, as indicated by a significant drop in grades; and improvement following treatment.

Using this definition, the study revealed that all patients had significant cognitive dysfunction, said Dr. Lim. “What's special is that our patients had actually reported these problems. For example, their short-term memory was bad; they couldn't remember what they ate for breakfast, or what their homework was. They also couldn't learn new stuff at school, they had word-finding difficulties, and they were also not doing well in school. So you may have had an A student going down to C.”

She said that 85% of the subjects had concentration difficulties, 77% had memory deficits, 23% had psychomotor slowing, and 21% had decreased comprehension. Two patients also had prominent depressive features.

In addition, 75% of the subjects also had psychosis with hallucinations. In 83% the hallucinations were auditory, 75% were visual, and 20% were tactile. Visual distortion also was reported in 38% of this psychosis subset, she said.

In all, 42 of the 53 patients underwent magnetic resonance brain imaging, of whom 45% had normal results, 29% had cerebral atrophy only, and 17% had nonspecific white matter changes only. Of the 53 patients, 28 underwent lumbar puncture, of whom 64% had normal results, 29% had elevated total protein, and 7% had an elevated white cell count.

Prednisone was started in all patients and increased according to standard protocol. In addition, all but three patients required second-line immunosuppressant therapy (85% with azathioprine, 55% with cyclophosphamide, and 28% with mycophenolate).

“What we're finding is that even among second-line immunosuppressants, cyclophosphamide is turning out to be something that is very useful,” commented Dr. Lim. “When we start patients on azathioprine because their symptoms are mainly cognitive, or they have only mild psychotic symptoms, we find that a third actually need to be switched over.” Of the patients with psychosis, 60% (n = 24) also required antipsychotic therapy.

 

 

The investigators were able to collect data on response to therapy for some of the patients: Six relapsed and 25 went on to remission (although 3 of these eventually relapsed).

Response was defined as the absence of psychiatric symptoms, no antipsychotic medication, and prednisone at less than 50% of the peak dose for at least 3 months. Remission was defined as absence of psychiatric symptoms, no antipsychotic medication, prednisone at 10 mg or less a day, or 0.2 mg/kg per day or less for at least 3 months. And relapse was defined as a recurrence of psychiatric symptoms, a requirement of at least a 50% increase in prednisone dose, or a change in second-line immunosuppressive agents (not due to adverse effects), or the addition of antipsychotic medication. There were 14 nonresponders. “The nonresponse may be because they presented in adolescence, and the follow-up was short before they transferred to an adult clinic,” she said.

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Clinically Quiescent Lupus Does Not Progress

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Clinically Quiescent Lupus Does Not Progress

Montreal — Patients with systemic lupus erythematosus that is serologically active but clinically quiescent do not require treatment with steroids or immunosuppressive agents until the disease flares, according to a study presented at the annual meeting of the Canadian Rheumatology Association.

Until now, patients with such discordant findings have presented a clinical dilemma, said Dr. Amanda Steiman, who presented the study's findings.

“Many physicians have wondered whether or not treatment is warranted in light of just the serological activity in the absence of any clinical disease,” she said in an interview. “Does lupus progress subclinically during a quiescent period?”

Her study followed 55 patients with serologically active, clinically quiescent (SACQ) systemic lupus erythematosus over a 10-year period, and compared their outcomes to those of 110 controls with classic SLE who were matched for age, sex, disease duration, and decade of clinic entry.

Patients and controls were also matched for baseline damage according to the SDI (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index), incidence of renal damage, and incidence of coronary artery disease.

SACQ was defined as a minimum of 2 years without clinical activity and persistent serologic activity as defined by elevated anti–double stranded DNA and/or hypocomplementemia. Antimalarials were permissible during an SACQ period, but steroids or immunosuppressives were not.

The study found that, compared with controls, SACQ patients showed very little subclinical progression. At 3 years after the start of the study, SDI damage in the SACQ patients was 0.7 vs. 1.13 in controls; this pattern persisted at 5 years (0.89 vs. 1.36), 7 years (0.94 vs. 1.71), and 10 years (1.26 vs. 2.26).

Similarly, whereas 3.6% of the SACQ patients vs. 6.4% of controls had coronary artery disease at baseline, new cases of CAD (myocardial infarction, angina, or sudden cardiac death) occurred in 1.8% of SACQ patients vs. 7.3% of controls over the 10-year study.

One (1.8%) SACQ patient vs. 15.5% of controls had renal damage at 5 years, and at 10 years these numbers rose to 3.6% of SACQ patients and 23.6% of controls.

Both disease and treatment can result in lupus-related damage, said Dr. Steiman, who is a rheumatology fellow at the University of Toronto.

“The SDI differentiates between damage which is definitely corticosteroid related (specifically ocular and musculoskeletal damage) vs. possibly corticosteroid related (such as cardiovascular, peripheral vascular, neuropsychiatric, and diabetic damage) vs. damage that occurs independent of corticosteroid use (specifically renal, pulmonary, dermatologic, and gonadal damage), as well as malignancy,” she said.

“Especially later in the course of lupus—these patients were 11 years plus into their lupus course—a lot of the damage is related to treatment morbidity,” she said in an interview. “If we can avoid that for a good number of years, then we are going to spare the people the morbidity associated with the treatment.” This subset of patients has less progressive disease-related damage, she added. Findings from a previous study by Dr. Steiman's associates showed that patients with SACQ represent about 6% of the SLE population. Approximately 60% of them flare and require treatment after a median of 3 years.

Findings from the present study show that SACQ patients used antimalarials, corticosteroids, and immunosuppressives at rates of 60%, 18%, and 5%, respectively, during the study period, compared with 77%, 76%, and 44% in controls.

“The SACQ period can be a very prolonged period without a flare, and at our center we have not been treating these patients.

“Our study supports the practice of active surveillance without treatment, so that's reassuring.”

Disclosures: Dr. Steiman stated that she had no conflicts to disclose.

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Montreal — Patients with systemic lupus erythematosus that is serologically active but clinically quiescent do not require treatment with steroids or immunosuppressive agents until the disease flares, according to a study presented at the annual meeting of the Canadian Rheumatology Association.

Until now, patients with such discordant findings have presented a clinical dilemma, said Dr. Amanda Steiman, who presented the study's findings.

“Many physicians have wondered whether or not treatment is warranted in light of just the serological activity in the absence of any clinical disease,” she said in an interview. “Does lupus progress subclinically during a quiescent period?”

Her study followed 55 patients with serologically active, clinically quiescent (SACQ) systemic lupus erythematosus over a 10-year period, and compared their outcomes to those of 110 controls with classic SLE who were matched for age, sex, disease duration, and decade of clinic entry.

Patients and controls were also matched for baseline damage according to the SDI (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index), incidence of renal damage, and incidence of coronary artery disease.

SACQ was defined as a minimum of 2 years without clinical activity and persistent serologic activity as defined by elevated anti–double stranded DNA and/or hypocomplementemia. Antimalarials were permissible during an SACQ period, but steroids or immunosuppressives were not.

The study found that, compared with controls, SACQ patients showed very little subclinical progression. At 3 years after the start of the study, SDI damage in the SACQ patients was 0.7 vs. 1.13 in controls; this pattern persisted at 5 years (0.89 vs. 1.36), 7 years (0.94 vs. 1.71), and 10 years (1.26 vs. 2.26).

Similarly, whereas 3.6% of the SACQ patients vs. 6.4% of controls had coronary artery disease at baseline, new cases of CAD (myocardial infarction, angina, or sudden cardiac death) occurred in 1.8% of SACQ patients vs. 7.3% of controls over the 10-year study.

One (1.8%) SACQ patient vs. 15.5% of controls had renal damage at 5 years, and at 10 years these numbers rose to 3.6% of SACQ patients and 23.6% of controls.

Both disease and treatment can result in lupus-related damage, said Dr. Steiman, who is a rheumatology fellow at the University of Toronto.

“The SDI differentiates between damage which is definitely corticosteroid related (specifically ocular and musculoskeletal damage) vs. possibly corticosteroid related (such as cardiovascular, peripheral vascular, neuropsychiatric, and diabetic damage) vs. damage that occurs independent of corticosteroid use (specifically renal, pulmonary, dermatologic, and gonadal damage), as well as malignancy,” she said.

“Especially later in the course of lupus—these patients were 11 years plus into their lupus course—a lot of the damage is related to treatment morbidity,” she said in an interview. “If we can avoid that for a good number of years, then we are going to spare the people the morbidity associated with the treatment.” This subset of patients has less progressive disease-related damage, she added. Findings from a previous study by Dr. Steiman's associates showed that patients with SACQ represent about 6% of the SLE population. Approximately 60% of them flare and require treatment after a median of 3 years.

Findings from the present study show that SACQ patients used antimalarials, corticosteroids, and immunosuppressives at rates of 60%, 18%, and 5%, respectively, during the study period, compared with 77%, 76%, and 44% in controls.

“The SACQ period can be a very prolonged period without a flare, and at our center we have not been treating these patients.

“Our study supports the practice of active surveillance without treatment, so that's reassuring.”

Disclosures: Dr. Steiman stated that she had no conflicts to disclose.

Montreal — Patients with systemic lupus erythematosus that is serologically active but clinically quiescent do not require treatment with steroids or immunosuppressive agents until the disease flares, according to a study presented at the annual meeting of the Canadian Rheumatology Association.

Until now, patients with such discordant findings have presented a clinical dilemma, said Dr. Amanda Steiman, who presented the study's findings.

“Many physicians have wondered whether or not treatment is warranted in light of just the serological activity in the absence of any clinical disease,” she said in an interview. “Does lupus progress subclinically during a quiescent period?”

Her study followed 55 patients with serologically active, clinically quiescent (SACQ) systemic lupus erythematosus over a 10-year period, and compared their outcomes to those of 110 controls with classic SLE who were matched for age, sex, disease duration, and decade of clinic entry.

Patients and controls were also matched for baseline damage according to the SDI (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index), incidence of renal damage, and incidence of coronary artery disease.

SACQ was defined as a minimum of 2 years without clinical activity and persistent serologic activity as defined by elevated anti–double stranded DNA and/or hypocomplementemia. Antimalarials were permissible during an SACQ period, but steroids or immunosuppressives were not.

The study found that, compared with controls, SACQ patients showed very little subclinical progression. At 3 years after the start of the study, SDI damage in the SACQ patients was 0.7 vs. 1.13 in controls; this pattern persisted at 5 years (0.89 vs. 1.36), 7 years (0.94 vs. 1.71), and 10 years (1.26 vs. 2.26).

Similarly, whereas 3.6% of the SACQ patients vs. 6.4% of controls had coronary artery disease at baseline, new cases of CAD (myocardial infarction, angina, or sudden cardiac death) occurred in 1.8% of SACQ patients vs. 7.3% of controls over the 10-year study.

One (1.8%) SACQ patient vs. 15.5% of controls had renal damage at 5 years, and at 10 years these numbers rose to 3.6% of SACQ patients and 23.6% of controls.

Both disease and treatment can result in lupus-related damage, said Dr. Steiman, who is a rheumatology fellow at the University of Toronto.

“The SDI differentiates between damage which is definitely corticosteroid related (specifically ocular and musculoskeletal damage) vs. possibly corticosteroid related (such as cardiovascular, peripheral vascular, neuropsychiatric, and diabetic damage) vs. damage that occurs independent of corticosteroid use (specifically renal, pulmonary, dermatologic, and gonadal damage), as well as malignancy,” she said.

“Especially later in the course of lupus—these patients were 11 years plus into their lupus course—a lot of the damage is related to treatment morbidity,” she said in an interview. “If we can avoid that for a good number of years, then we are going to spare the people the morbidity associated with the treatment.” This subset of patients has less progressive disease-related damage, she added. Findings from a previous study by Dr. Steiman's associates showed that patients with SACQ represent about 6% of the SLE population. Approximately 60% of them flare and require treatment after a median of 3 years.

Findings from the present study show that SACQ patients used antimalarials, corticosteroids, and immunosuppressives at rates of 60%, 18%, and 5%, respectively, during the study period, compared with 77%, 76%, and 44% in controls.

“The SACQ period can be a very prolonged period without a flare, and at our center we have not been treating these patients.

“Our study supports the practice of active surveillance without treatment, so that's reassuring.”

Disclosures: Dr. Steiman stated that she had no conflicts to disclose.

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Index Measures Partial Improvement in SLE

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Major Finding: The SRI-50 tool signaled 50% improvement in 13 of the 24 SLEDAI-2K descriptors and in six of the nine assessed organ systems, findings that were undetected by the less-sensitive SLEDAI-2K.

Data Source: Results of SRI-50 in 100 patients.

Disclosures: Dr. Touma said he had no relevant financial conflicts to disclose.

MONTREAL — A proposed new tool that is sensitive enough to measure partial improvement in systemic lupus erythematosus could open the door to more precise monitoring of therapeutic response in both research and clinical practice, reported Dr. Zahi Touma at the annual meeting of the Canadian Rheumatology Association.

Currently, improvement in disease activity, or response to treatment, can be measured only as absent or present, using the SLEDAI-2K (Systemic Lupus Erythematosus Activity Index–2K), explained Dr. Touma, a clinical research fellow in rheumatology at the center for prognosis studies in the rheumatic diseases at the University of Toronto. However, this index is not designed to detect small but clinically meaningful improvements, he noted.

So his group developed a modified version, the SRI-50 (SLEDAI-2K Responder Index–50), which has been designed to capture at least a 50% response on the SLEDAI-2K. “We aimed to show a 50% improvement, because this was felt by clinicians to reflect a significant improvement,” he said in an interview.

The SRI-50 covers the same nine organ systems and uses the same 24 descriptors as does the SLEDAI-2K, said Dr. Touma. Scoring for each descriptor of SLEDAI-2K is halved to generate a new weighted score for each descriptor of the SRI-50.

For example, in a case of lupus nephritis that involves proteinuria at a level of serum protein in urine of 4 g/day, the SLEDAI-2K score would be 4.

At follow-up, a decrease in proteinuria to 2 g/day would generate the same SLEDAI-2K score of 4 (which is generated by any proteinuria above 0.5 g/day), but on the SRI-50, it would represent a 50% improvement and thus a score of 2.

To test the new measure, Dr. Touma's group performed a cross-sectional study of 100 patients who had experienced lupus flares or had persistently active disease.

The SLEDAI-2K was administered at the initial visit and then again after 1-3 months of treatment with prednisone and an immunosuppressant (hydroxychloroquine, azathioprine, methotrexate, or mycophenolate mofetil). The SRI-50 was also administered at the second visit.

Scores were calculated using a data retrieval form, with a range of scores from 1 (best) to 10 (worst) for each of the 24 descriptors. “It's very important to have a data retrieval form because if you are dealing with rash or arthritis you need a very accurate, standardized method of documentation,” he said.

For 72 patients, the SLEDAI-2K provided a satisfactory assessment at the second visit because their disease had either resolved completely or remained unchanged. However, for the remaining 28 patients, the SRI-50 signaled partial improvement that was undetected by the less-sensitive SLEDAI-2K. Among these patients, a 50% improvement was detected in 13 of the 24 descriptors and in six of the nine organ systems, said Dr. Touma.

Among these 28 patients, 90% were female, 53% were white, 16% were black, 10% were Chinese, and 21% were “other.” Their mean age at diagnosis was 32 years, and their mean duration of disease at first study visit was 13 years. Varying levels of disease activity were recorded at the first visit.

Three subjects had a SLEDAI-2K score of 2; three had a score of 4; six had a score of 6; six had a score of 8; three had a score of 10; two had a score of 12; one had a score of 16; one had a score of 18; two had a score of 20; and one had a score of 21.

Dr. Touma said the goal of the study was primarily to develop a more sensitive tool to measure outcomes in clinical trials. However, he believes the SRI-50 will also play an important role in clinical practice, where “it is always crucial to be able to show that a patient is responding to medical treatment.”

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Major Finding: The SRI-50 tool signaled 50% improvement in 13 of the 24 SLEDAI-2K descriptors and in six of the nine assessed organ systems, findings that were undetected by the less-sensitive SLEDAI-2K.

Data Source: Results of SRI-50 in 100 patients.

Disclosures: Dr. Touma said he had no relevant financial conflicts to disclose.

MONTREAL — A proposed new tool that is sensitive enough to measure partial improvement in systemic lupus erythematosus could open the door to more precise monitoring of therapeutic response in both research and clinical practice, reported Dr. Zahi Touma at the annual meeting of the Canadian Rheumatology Association.

Currently, improvement in disease activity, or response to treatment, can be measured only as absent or present, using the SLEDAI-2K (Systemic Lupus Erythematosus Activity Index–2K), explained Dr. Touma, a clinical research fellow in rheumatology at the center for prognosis studies in the rheumatic diseases at the University of Toronto. However, this index is not designed to detect small but clinically meaningful improvements, he noted.

So his group developed a modified version, the SRI-50 (SLEDAI-2K Responder Index–50), which has been designed to capture at least a 50% response on the SLEDAI-2K. “We aimed to show a 50% improvement, because this was felt by clinicians to reflect a significant improvement,” he said in an interview.

The SRI-50 covers the same nine organ systems and uses the same 24 descriptors as does the SLEDAI-2K, said Dr. Touma. Scoring for each descriptor of SLEDAI-2K is halved to generate a new weighted score for each descriptor of the SRI-50.

For example, in a case of lupus nephritis that involves proteinuria at a level of serum protein in urine of 4 g/day, the SLEDAI-2K score would be 4.

At follow-up, a decrease in proteinuria to 2 g/day would generate the same SLEDAI-2K score of 4 (which is generated by any proteinuria above 0.5 g/day), but on the SRI-50, it would represent a 50% improvement and thus a score of 2.

To test the new measure, Dr. Touma's group performed a cross-sectional study of 100 patients who had experienced lupus flares or had persistently active disease.

The SLEDAI-2K was administered at the initial visit and then again after 1-3 months of treatment with prednisone and an immunosuppressant (hydroxychloroquine, azathioprine, methotrexate, or mycophenolate mofetil). The SRI-50 was also administered at the second visit.

Scores were calculated using a data retrieval form, with a range of scores from 1 (best) to 10 (worst) for each of the 24 descriptors. “It's very important to have a data retrieval form because if you are dealing with rash or arthritis you need a very accurate, standardized method of documentation,” he said.

For 72 patients, the SLEDAI-2K provided a satisfactory assessment at the second visit because their disease had either resolved completely or remained unchanged. However, for the remaining 28 patients, the SRI-50 signaled partial improvement that was undetected by the less-sensitive SLEDAI-2K. Among these patients, a 50% improvement was detected in 13 of the 24 descriptors and in six of the nine organ systems, said Dr. Touma.

Among these 28 patients, 90% were female, 53% were white, 16% were black, 10% were Chinese, and 21% were “other.” Their mean age at diagnosis was 32 years, and their mean duration of disease at first study visit was 13 years. Varying levels of disease activity were recorded at the first visit.

Three subjects had a SLEDAI-2K score of 2; three had a score of 4; six had a score of 6; six had a score of 8; three had a score of 10; two had a score of 12; one had a score of 16; one had a score of 18; two had a score of 20; and one had a score of 21.

Dr. Touma said the goal of the study was primarily to develop a more sensitive tool to measure outcomes in clinical trials. However, he believes the SRI-50 will also play an important role in clinical practice, where “it is always crucial to be able to show that a patient is responding to medical treatment.”

Major Finding: The SRI-50 tool signaled 50% improvement in 13 of the 24 SLEDAI-2K descriptors and in six of the nine assessed organ systems, findings that were undetected by the less-sensitive SLEDAI-2K.

Data Source: Results of SRI-50 in 100 patients.

Disclosures: Dr. Touma said he had no relevant financial conflicts to disclose.

MONTREAL — A proposed new tool that is sensitive enough to measure partial improvement in systemic lupus erythematosus could open the door to more precise monitoring of therapeutic response in both research and clinical practice, reported Dr. Zahi Touma at the annual meeting of the Canadian Rheumatology Association.

Currently, improvement in disease activity, or response to treatment, can be measured only as absent or present, using the SLEDAI-2K (Systemic Lupus Erythematosus Activity Index–2K), explained Dr. Touma, a clinical research fellow in rheumatology at the center for prognosis studies in the rheumatic diseases at the University of Toronto. However, this index is not designed to detect small but clinically meaningful improvements, he noted.

So his group developed a modified version, the SRI-50 (SLEDAI-2K Responder Index–50), which has been designed to capture at least a 50% response on the SLEDAI-2K. “We aimed to show a 50% improvement, because this was felt by clinicians to reflect a significant improvement,” he said in an interview.

The SRI-50 covers the same nine organ systems and uses the same 24 descriptors as does the SLEDAI-2K, said Dr. Touma. Scoring for each descriptor of SLEDAI-2K is halved to generate a new weighted score for each descriptor of the SRI-50.

For example, in a case of lupus nephritis that involves proteinuria at a level of serum protein in urine of 4 g/day, the SLEDAI-2K score would be 4.

At follow-up, a decrease in proteinuria to 2 g/day would generate the same SLEDAI-2K score of 4 (which is generated by any proteinuria above 0.5 g/day), but on the SRI-50, it would represent a 50% improvement and thus a score of 2.

To test the new measure, Dr. Touma's group performed a cross-sectional study of 100 patients who had experienced lupus flares or had persistently active disease.

The SLEDAI-2K was administered at the initial visit and then again after 1-3 months of treatment with prednisone and an immunosuppressant (hydroxychloroquine, azathioprine, methotrexate, or mycophenolate mofetil). The SRI-50 was also administered at the second visit.

Scores were calculated using a data retrieval form, with a range of scores from 1 (best) to 10 (worst) for each of the 24 descriptors. “It's very important to have a data retrieval form because if you are dealing with rash or arthritis you need a very accurate, standardized method of documentation,” he said.

For 72 patients, the SLEDAI-2K provided a satisfactory assessment at the second visit because their disease had either resolved completely or remained unchanged. However, for the remaining 28 patients, the SRI-50 signaled partial improvement that was undetected by the less-sensitive SLEDAI-2K. Among these patients, a 50% improvement was detected in 13 of the 24 descriptors and in six of the nine organ systems, said Dr. Touma.

Among these 28 patients, 90% were female, 53% were white, 16% were black, 10% were Chinese, and 21% were “other.” Their mean age at diagnosis was 32 years, and their mean duration of disease at first study visit was 13 years. Varying levels of disease activity were recorded at the first visit.

Three subjects had a SLEDAI-2K score of 2; three had a score of 4; six had a score of 6; six had a score of 8; three had a score of 10; two had a score of 12; one had a score of 16; one had a score of 18; two had a score of 20; and one had a score of 21.

Dr. Touma said the goal of the study was primarily to develop a more sensitive tool to measure outcomes in clinical trials. However, he believes the SRI-50 will also play an important role in clinical practice, where “it is always crucial to be able to show that a patient is responding to medical treatment.”

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Genetics Education Boosted Provider Confidence : Primary care physicians who took the course were more likely to refer patients appropriately.

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A 6-month genetics educational initiative significantly improved the confidence and competence of family physicians, according to the findings of a small study.

“Primary care providers are going to be increasingly involved in the delivery [of genetics services]. There's a huge literature out there that we're deficient in. We have to be able to assess risk. We have to know when to refer. We have to provide counseling and follow-up after test results. And we are probably increasingly going to be asked to tailor our preventive care, medication choice, and treatments to people's individual genetic profiles,” said Dr. June Carroll, the Sydney G. Frankfort Chair in Family Medicine at Mount Sinai Hospital and the University of Toronto.

The study randomized 125 primary care physicians to an educational intervention (61 physicians) aimed at improving primary care genetics skills, or to a control arm (64 physicians), that received the educational material at the end of the study.

Participating physicians came from both rural and urban practices in the province of Ontario.

The intervention involved a 1-hour workshop conducted by a genetics counselor and a family physician, and a portfolio of primary care–appropriate genetics “tools,” such as genetics pearls, red flags, risk-triage cards, and tables outlining possible consequences of genetic test results.

The most exciting aspect was access to an information service called “Gene Messenger,” according to Dr. Carroll. “Our team scanned the newspapers every day during the time of the trial, and we looked for any big headlines or articles about a new genetic test or a genetic disorder. We then very rapidly developed a critical review of that disorder or test, and came up with bottom-line recommendations for primary care,” she explained.

The one- to two-page reports were written by a genetics counselor, with input from geneticists and family physicians, and were e-mailed or faxed to study participants every 2 weeks during the 6 months of the study.

“We produced 16 of these reviews over the course of the project. They were as evidence based as possible, although sometimes we did have to use expert opinion. And they were fully referenced,” she said.

Study participants were assessed 1 month before and 6 months after the intervention for the primary outcome of the study, which was the appropriate intention to refer a patient for genetic counseling. Secondary outcomes looked at the participants' perception of the difficulty in making a decision and their self-rated confidence in a set of 11 core genetics competencies, as defined by the National Coalition for Health Professional Education in Genetics.

All participating physicians also answered the following three questions about hereditary breast and colorectal cancer:

▸ Is there paternal inheritance of the BRCA mutations? (Answer: yes)

▸ What percentage of breast cancer patients have a BRCA mutation? (Answer: fewer than 10%)

▸ What percentage of people with the HNPCC (hereditary nonpolyposis colo-rectal cancer) gene will get colorectal cancer? (Answer: more than 50%)

These are the “big ticket items” in genetics that family physicians need to know in order to advise their patients, she said.

Compared with physicians in the control arm, those in the intervention arm showed a statistically significant improvement from baseline in their appropriate intention to refer patients, based on a set of 10 clinical vignettes (7.8 of 10 vs. 6.4 of 10 for controls).

In addition, self-reported confidence was significantly higher among physicians in the intervention group (43 of 55, compared with 34 in the control group).

“We saw an increase across all 11 items of family physician core competencies in genetics,” said Dr. Carroll. For example, physicians were more confident eliciting genetic information from a family history; doing risk assessment and deciding who should be offered referral; discussing risks, benefits, and limitations of genetic testing; knowing where to refer; providing psychosocial support for those who have had genetic test results; providing management and following people who have had genetic test results; and reassuring patients who are at low risk. Handling all of these areas is “going to be a big job for us in the future,” she said.

Yet despite their increased confidence, physicians in the intervention group scored no better than controls on the first two knowledge questions. The percentage of correct answers “was low for two of the questions, and a large percentage said they weren't sure,” said Dr. Carroll.

The group hopes to expand the intervention to include a wider range of conditions, and to distribute the material to more physicians. “It would be ideal to have one center that was developing these reviews and recommendations in response to the media and new discoveries, and having them disseminated widely so that family physicians could get timely information to share with their patients about new genetic information,” she said.

 

 

The Gene Messengers are being published by Canadian Family Physician and can be seen at www.cfp.ca/misc/collections.dtlwww.mtsinai.on.ca/FamMedGen

The study was funded by the Canadian Institutes of Health Research, and Dr. Carroll reported having no conflicts of interest.

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A 6-month genetics educational initiative significantly improved the confidence and competence of family physicians, according to the findings of a small study.

“Primary care providers are going to be increasingly involved in the delivery [of genetics services]. There's a huge literature out there that we're deficient in. We have to be able to assess risk. We have to know when to refer. We have to provide counseling and follow-up after test results. And we are probably increasingly going to be asked to tailor our preventive care, medication choice, and treatments to people's individual genetic profiles,” said Dr. June Carroll, the Sydney G. Frankfort Chair in Family Medicine at Mount Sinai Hospital and the University of Toronto.

The study randomized 125 primary care physicians to an educational intervention (61 physicians) aimed at improving primary care genetics skills, or to a control arm (64 physicians), that received the educational material at the end of the study.

Participating physicians came from both rural and urban practices in the province of Ontario.

The intervention involved a 1-hour workshop conducted by a genetics counselor and a family physician, and a portfolio of primary care–appropriate genetics “tools,” such as genetics pearls, red flags, risk-triage cards, and tables outlining possible consequences of genetic test results.

The most exciting aspect was access to an information service called “Gene Messenger,” according to Dr. Carroll. “Our team scanned the newspapers every day during the time of the trial, and we looked for any big headlines or articles about a new genetic test or a genetic disorder. We then very rapidly developed a critical review of that disorder or test, and came up with bottom-line recommendations for primary care,” she explained.

The one- to two-page reports were written by a genetics counselor, with input from geneticists and family physicians, and were e-mailed or faxed to study participants every 2 weeks during the 6 months of the study.

“We produced 16 of these reviews over the course of the project. They were as evidence based as possible, although sometimes we did have to use expert opinion. And they were fully referenced,” she said.

Study participants were assessed 1 month before and 6 months after the intervention for the primary outcome of the study, which was the appropriate intention to refer a patient for genetic counseling. Secondary outcomes looked at the participants' perception of the difficulty in making a decision and their self-rated confidence in a set of 11 core genetics competencies, as defined by the National Coalition for Health Professional Education in Genetics.

All participating physicians also answered the following three questions about hereditary breast and colorectal cancer:

▸ Is there paternal inheritance of the BRCA mutations? (Answer: yes)

▸ What percentage of breast cancer patients have a BRCA mutation? (Answer: fewer than 10%)

▸ What percentage of people with the HNPCC (hereditary nonpolyposis colo-rectal cancer) gene will get colorectal cancer? (Answer: more than 50%)

These are the “big ticket items” in genetics that family physicians need to know in order to advise their patients, she said.

Compared with physicians in the control arm, those in the intervention arm showed a statistically significant improvement from baseline in their appropriate intention to refer patients, based on a set of 10 clinical vignettes (7.8 of 10 vs. 6.4 of 10 for controls).

In addition, self-reported confidence was significantly higher among physicians in the intervention group (43 of 55, compared with 34 in the control group).

“We saw an increase across all 11 items of family physician core competencies in genetics,” said Dr. Carroll. For example, physicians were more confident eliciting genetic information from a family history; doing risk assessment and deciding who should be offered referral; discussing risks, benefits, and limitations of genetic testing; knowing where to refer; providing psychosocial support for those who have had genetic test results; providing management and following people who have had genetic test results; and reassuring patients who are at low risk. Handling all of these areas is “going to be a big job for us in the future,” she said.

Yet despite their increased confidence, physicians in the intervention group scored no better than controls on the first two knowledge questions. The percentage of correct answers “was low for two of the questions, and a large percentage said they weren't sure,” said Dr. Carroll.

The group hopes to expand the intervention to include a wider range of conditions, and to distribute the material to more physicians. “It would be ideal to have one center that was developing these reviews and recommendations in response to the media and new discoveries, and having them disseminated widely so that family physicians could get timely information to share with their patients about new genetic information,” she said.

 

 

The Gene Messengers are being published by Canadian Family Physician and can be seen at www.cfp.ca/misc/collections.dtlwww.mtsinai.on.ca/FamMedGen

The study was funded by the Canadian Institutes of Health Research, and Dr. Carroll reported having no conflicts of interest.

A 6-month genetics educational initiative significantly improved the confidence and competence of family physicians, according to the findings of a small study.

“Primary care providers are going to be increasingly involved in the delivery [of genetics services]. There's a huge literature out there that we're deficient in. We have to be able to assess risk. We have to know when to refer. We have to provide counseling and follow-up after test results. And we are probably increasingly going to be asked to tailor our preventive care, medication choice, and treatments to people's individual genetic profiles,” said Dr. June Carroll, the Sydney G. Frankfort Chair in Family Medicine at Mount Sinai Hospital and the University of Toronto.

The study randomized 125 primary care physicians to an educational intervention (61 physicians) aimed at improving primary care genetics skills, or to a control arm (64 physicians), that received the educational material at the end of the study.

Participating physicians came from both rural and urban practices in the province of Ontario.

The intervention involved a 1-hour workshop conducted by a genetics counselor and a family physician, and a portfolio of primary care–appropriate genetics “tools,” such as genetics pearls, red flags, risk-triage cards, and tables outlining possible consequences of genetic test results.

The most exciting aspect was access to an information service called “Gene Messenger,” according to Dr. Carroll. “Our team scanned the newspapers every day during the time of the trial, and we looked for any big headlines or articles about a new genetic test or a genetic disorder. We then very rapidly developed a critical review of that disorder or test, and came up with bottom-line recommendations for primary care,” she explained.

The one- to two-page reports were written by a genetics counselor, with input from geneticists and family physicians, and were e-mailed or faxed to study participants every 2 weeks during the 6 months of the study.

“We produced 16 of these reviews over the course of the project. They were as evidence based as possible, although sometimes we did have to use expert opinion. And they were fully referenced,” she said.

Study participants were assessed 1 month before and 6 months after the intervention for the primary outcome of the study, which was the appropriate intention to refer a patient for genetic counseling. Secondary outcomes looked at the participants' perception of the difficulty in making a decision and their self-rated confidence in a set of 11 core genetics competencies, as defined by the National Coalition for Health Professional Education in Genetics.

All participating physicians also answered the following three questions about hereditary breast and colorectal cancer:

▸ Is there paternal inheritance of the BRCA mutations? (Answer: yes)

▸ What percentage of breast cancer patients have a BRCA mutation? (Answer: fewer than 10%)

▸ What percentage of people with the HNPCC (hereditary nonpolyposis colo-rectal cancer) gene will get colorectal cancer? (Answer: more than 50%)

These are the “big ticket items” in genetics that family physicians need to know in order to advise their patients, she said.

Compared with physicians in the control arm, those in the intervention arm showed a statistically significant improvement from baseline in their appropriate intention to refer patients, based on a set of 10 clinical vignettes (7.8 of 10 vs. 6.4 of 10 for controls).

In addition, self-reported confidence was significantly higher among physicians in the intervention group (43 of 55, compared with 34 in the control group).

“We saw an increase across all 11 items of family physician core competencies in genetics,” said Dr. Carroll. For example, physicians were more confident eliciting genetic information from a family history; doing risk assessment and deciding who should be offered referral; discussing risks, benefits, and limitations of genetic testing; knowing where to refer; providing psychosocial support for those who have had genetic test results; providing management and following people who have had genetic test results; and reassuring patients who are at low risk. Handling all of these areas is “going to be a big job for us in the future,” she said.

Yet despite their increased confidence, physicians in the intervention group scored no better than controls on the first two knowledge questions. The percentage of correct answers “was low for two of the questions, and a large percentage said they weren't sure,” said Dr. Carroll.

The group hopes to expand the intervention to include a wider range of conditions, and to distribute the material to more physicians. “It would be ideal to have one center that was developing these reviews and recommendations in response to the media and new discoveries, and having them disseminated widely so that family physicians could get timely information to share with their patients about new genetic information,” she said.

 

 

The Gene Messengers are being published by Canadian Family Physician and can be seen at www.cfp.ca/misc/collections.dtlwww.mtsinai.on.ca/FamMedGen

The study was funded by the Canadian Institutes of Health Research, and Dr. Carroll reported having no conflicts of interest.

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Target Interventions to Specific Communities

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MONTREAL — Locally designed and delivered lifestyle interventions can result in clinically meaningful improvements in patient health, according to preliminary findings from a statewide initiative aimed at decreasing health disparities.

“The idea behind it is to locally define the interventions, because the people who live and work in those communities know the most about what might work best,” said Lauren Whetstone, Ph.D., who presented the findings in a poster at the annual meeting of the North American Primary Care Research Group.

Using a $9.2 million grant from the North Carolina Health and Wellness Trust Fund, 18 local governments and nonprofit organizations developed local interventions targeting obesity, cardiovascular disease, diabetes, and lifestyle issues in the specific communities.

Most of the communities had large African American or Native American populations that were underserved and had poor access to health care, explained Dr. Whetstone of East Carolina University, Greenville, N.C.

Some of the interventions involved health systems implementing home medical visits for diabetic patients. Other interventions involved churches establishing physical exercise and nutrition classes before Bible study, Dr. Whetstone explained in an interview.

In each community, a cohort of participants were followed longitudinally for an average of 19.5 months. Data were collected on biologic and behavioral outcomes such as blood pressure, blood glucose and cholesterol levels, dietary habits, physical activity, and smoking.

Each community had different needs, so the interventions were different and the specific measures for determining outcomes varied. However, a collective analysis of the combined data for 2,504 participants (average age, 53 years) showed a positive impact in several areas.

Among 67 diabetic patients, mean hemoglobin A1c levels dropped from a baseline level of 8.9% to 8.0% by the end of the study period.

Among 203 hypertensive patients, mean systolic blood pressure dropped from a baseline of 141.62 mm Hg to 137.24 mm Hg.

Mean body mass index did not change, but data from the first half of the study period showed significant increases in self-reported daily fruit and vegetable intake (2.34 to 2.88 servings), mean days of physical activity per week (3.22 to 3.56), and mean self-rated health. There was a slight decrease in the number of current smokers (13.9% to 13.2%).

Although the study had significant limitations, including possible selection bias and lack of controls, improvements of this magnitude, if sustained, have been associated with reductions in diabetes and cardiovascular morbidity and mortality, Dr. Whetstone said.

She attributed the success to the fact that the interventions were locally defined and administered. “We've learned a lot about the differences in how organizers work within one population compared to another,” she said. For example, within the Native American population, communication and the development of trust were rooted in the tribal circle, where all community organization and business is centered.

“I think going directly to communities is going to be the way we can make the most change,” said Dr. Sally P. Weaver, a meeting delegate who commented on the study.

Dr. Weaver, of the McLennan County Medical Education and Research Foundation in Waco, Tex., added that the study's blood pressure results were not clinically significant. However, she said she was particularly impressed by the reported drop in blood glucose levels.

“I was surprised to see that much of a change. It was clinically significant. So whatever they're doing is working,” she said.

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MONTREAL — Locally designed and delivered lifestyle interventions can result in clinically meaningful improvements in patient health, according to preliminary findings from a statewide initiative aimed at decreasing health disparities.

“The idea behind it is to locally define the interventions, because the people who live and work in those communities know the most about what might work best,” said Lauren Whetstone, Ph.D., who presented the findings in a poster at the annual meeting of the North American Primary Care Research Group.

Using a $9.2 million grant from the North Carolina Health and Wellness Trust Fund, 18 local governments and nonprofit organizations developed local interventions targeting obesity, cardiovascular disease, diabetes, and lifestyle issues in the specific communities.

Most of the communities had large African American or Native American populations that were underserved and had poor access to health care, explained Dr. Whetstone of East Carolina University, Greenville, N.C.

Some of the interventions involved health systems implementing home medical visits for diabetic patients. Other interventions involved churches establishing physical exercise and nutrition classes before Bible study, Dr. Whetstone explained in an interview.

In each community, a cohort of participants were followed longitudinally for an average of 19.5 months. Data were collected on biologic and behavioral outcomes such as blood pressure, blood glucose and cholesterol levels, dietary habits, physical activity, and smoking.

Each community had different needs, so the interventions were different and the specific measures for determining outcomes varied. However, a collective analysis of the combined data for 2,504 participants (average age, 53 years) showed a positive impact in several areas.

Among 67 diabetic patients, mean hemoglobin A1c levels dropped from a baseline level of 8.9% to 8.0% by the end of the study period.

Among 203 hypertensive patients, mean systolic blood pressure dropped from a baseline of 141.62 mm Hg to 137.24 mm Hg.

Mean body mass index did not change, but data from the first half of the study period showed significant increases in self-reported daily fruit and vegetable intake (2.34 to 2.88 servings), mean days of physical activity per week (3.22 to 3.56), and mean self-rated health. There was a slight decrease in the number of current smokers (13.9% to 13.2%).

Although the study had significant limitations, including possible selection bias and lack of controls, improvements of this magnitude, if sustained, have been associated with reductions in diabetes and cardiovascular morbidity and mortality, Dr. Whetstone said.

She attributed the success to the fact that the interventions were locally defined and administered. “We've learned a lot about the differences in how organizers work within one population compared to another,” she said. For example, within the Native American population, communication and the development of trust were rooted in the tribal circle, where all community organization and business is centered.

“I think going directly to communities is going to be the way we can make the most change,” said Dr. Sally P. Weaver, a meeting delegate who commented on the study.

Dr. Weaver, of the McLennan County Medical Education and Research Foundation in Waco, Tex., added that the study's blood pressure results were not clinically significant. However, she said she was particularly impressed by the reported drop in blood glucose levels.

“I was surprised to see that much of a change. It was clinically significant. So whatever they're doing is working,” she said.

MONTREAL — Locally designed and delivered lifestyle interventions can result in clinically meaningful improvements in patient health, according to preliminary findings from a statewide initiative aimed at decreasing health disparities.

“The idea behind it is to locally define the interventions, because the people who live and work in those communities know the most about what might work best,” said Lauren Whetstone, Ph.D., who presented the findings in a poster at the annual meeting of the North American Primary Care Research Group.

Using a $9.2 million grant from the North Carolina Health and Wellness Trust Fund, 18 local governments and nonprofit organizations developed local interventions targeting obesity, cardiovascular disease, diabetes, and lifestyle issues in the specific communities.

Most of the communities had large African American or Native American populations that were underserved and had poor access to health care, explained Dr. Whetstone of East Carolina University, Greenville, N.C.

Some of the interventions involved health systems implementing home medical visits for diabetic patients. Other interventions involved churches establishing physical exercise and nutrition classes before Bible study, Dr. Whetstone explained in an interview.

In each community, a cohort of participants were followed longitudinally for an average of 19.5 months. Data were collected on biologic and behavioral outcomes such as blood pressure, blood glucose and cholesterol levels, dietary habits, physical activity, and smoking.

Each community had different needs, so the interventions were different and the specific measures for determining outcomes varied. However, a collective analysis of the combined data for 2,504 participants (average age, 53 years) showed a positive impact in several areas.

Among 67 diabetic patients, mean hemoglobin A1c levels dropped from a baseline level of 8.9% to 8.0% by the end of the study period.

Among 203 hypertensive patients, mean systolic blood pressure dropped from a baseline of 141.62 mm Hg to 137.24 mm Hg.

Mean body mass index did not change, but data from the first half of the study period showed significant increases in self-reported daily fruit and vegetable intake (2.34 to 2.88 servings), mean days of physical activity per week (3.22 to 3.56), and mean self-rated health. There was a slight decrease in the number of current smokers (13.9% to 13.2%).

Although the study had significant limitations, including possible selection bias and lack of controls, improvements of this magnitude, if sustained, have been associated with reductions in diabetes and cardiovascular morbidity and mortality, Dr. Whetstone said.

She attributed the success to the fact that the interventions were locally defined and administered. “We've learned a lot about the differences in how organizers work within one population compared to another,” she said. For example, within the Native American population, communication and the development of trust were rooted in the tribal circle, where all community organization and business is centered.

“I think going directly to communities is going to be the way we can make the most change,” said Dr. Sally P. Weaver, a meeting delegate who commented on the study.

Dr. Weaver, of the McLennan County Medical Education and Research Foundation in Waco, Tex., added that the study's blood pressure results were not clinically significant. However, she said she was particularly impressed by the reported drop in blood glucose levels.

“I was surprised to see that much of a change. It was clinically significant. So whatever they're doing is working,” she said.

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Physicians Are Reticent About Taking On Bipolar Depression

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MONTREAL — Primary care physicians are not confident when it comes to diagnosing and managing patients with bipolar depression, according to a cross-sectional survey of providers participating in a national electronic health record database.

Among 85 primary care providers in GE Healthcare's Medical Quality Improvement Consortium, self-rated confidence in managing bipolar disorder averaged 1.7 on a scale of 1 to 5, with 5 being “very confident,” said Dr. Dana King, who presented the findings as a poster at the annual meeting of the North American Primary Care Research Group.

“For other more common disorders such as reflux disease, heart disease, or diabetes, these physicians have more confidence in their ability to sort out complex problems and deal with them. But bipolar disorder is less common and people have less exposure to it during their training,” explained Dr. King, a professor at the Medical University of South Carolina, Charleston.

Of the respondents, 86% had been using electronic health records for 3 or more years, and 94% had access to the Internet from their clinical workstations. At the same time, only 8% had recommended Web site information on bipolar disorder to their patients in the last 3 months.

Although 72% of the respondents said they screened depressed patients for bipolar disorder, 38% reported frequently using a standard screening tool, the most common being the Mood Disorder Questionnaire.

Informal screening was more common than was the use of standardized tools and consisted of “a few questions about manic activity in patients with depression,” Dr. King said. Such information screening may involve questions such as, “Do you go on spending sprees? Do you stay up all night? Do you find yourself having ups and downs, including periods of high irritability, anger, or stress?”

As the use of electronic medical records becomes more widespread, they may help prompt physicians to screen patients for bipolar disorder by offering pop-up information, he said. This represents an opportunity for quality improvement.

“Physicians seem to like the idea that we could offer them quick medical information via the electronic medical record that will give them some quick answers,” he said.

The survey did not include formal interviews, but discussions with the participants have revealed that they prefer referring patients with suspected bipolar disorder to mental health specialists if screening comes up positive, Dr. King said. “Many are willing to comanage the patient, but they first want the diagnosis to be confirmed, typed according to bipolar I or II, with an identification of the phase and recommended medications.”

The study was funded by Delaware Valley Outcomes Research and GE Healthcare as part of a quality improvement project dealing with several medical disorders.

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MONTREAL — Primary care physicians are not confident when it comes to diagnosing and managing patients with bipolar depression, according to a cross-sectional survey of providers participating in a national electronic health record database.

Among 85 primary care providers in GE Healthcare's Medical Quality Improvement Consortium, self-rated confidence in managing bipolar disorder averaged 1.7 on a scale of 1 to 5, with 5 being “very confident,” said Dr. Dana King, who presented the findings as a poster at the annual meeting of the North American Primary Care Research Group.

“For other more common disorders such as reflux disease, heart disease, or diabetes, these physicians have more confidence in their ability to sort out complex problems and deal with them. But bipolar disorder is less common and people have less exposure to it during their training,” explained Dr. King, a professor at the Medical University of South Carolina, Charleston.

Of the respondents, 86% had been using electronic health records for 3 or more years, and 94% had access to the Internet from their clinical workstations. At the same time, only 8% had recommended Web site information on bipolar disorder to their patients in the last 3 months.

Although 72% of the respondents said they screened depressed patients for bipolar disorder, 38% reported frequently using a standard screening tool, the most common being the Mood Disorder Questionnaire.

Informal screening was more common than was the use of standardized tools and consisted of “a few questions about manic activity in patients with depression,” Dr. King said. Such information screening may involve questions such as, “Do you go on spending sprees? Do you stay up all night? Do you find yourself having ups and downs, including periods of high irritability, anger, or stress?”

As the use of electronic medical records becomes more widespread, they may help prompt physicians to screen patients for bipolar disorder by offering pop-up information, he said. This represents an opportunity for quality improvement.

“Physicians seem to like the idea that we could offer them quick medical information via the electronic medical record that will give them some quick answers,” he said.

The survey did not include formal interviews, but discussions with the participants have revealed that they prefer referring patients with suspected bipolar disorder to mental health specialists if screening comes up positive, Dr. King said. “Many are willing to comanage the patient, but they first want the diagnosis to be confirmed, typed according to bipolar I or II, with an identification of the phase and recommended medications.”

The study was funded by Delaware Valley Outcomes Research and GE Healthcare as part of a quality improvement project dealing with several medical disorders.

MONTREAL — Primary care physicians are not confident when it comes to diagnosing and managing patients with bipolar depression, according to a cross-sectional survey of providers participating in a national electronic health record database.

Among 85 primary care providers in GE Healthcare's Medical Quality Improvement Consortium, self-rated confidence in managing bipolar disorder averaged 1.7 on a scale of 1 to 5, with 5 being “very confident,” said Dr. Dana King, who presented the findings as a poster at the annual meeting of the North American Primary Care Research Group.

“For other more common disorders such as reflux disease, heart disease, or diabetes, these physicians have more confidence in their ability to sort out complex problems and deal with them. But bipolar disorder is less common and people have less exposure to it during their training,” explained Dr. King, a professor at the Medical University of South Carolina, Charleston.

Of the respondents, 86% had been using electronic health records for 3 or more years, and 94% had access to the Internet from their clinical workstations. At the same time, only 8% had recommended Web site information on bipolar disorder to their patients in the last 3 months.

Although 72% of the respondents said they screened depressed patients for bipolar disorder, 38% reported frequently using a standard screening tool, the most common being the Mood Disorder Questionnaire.

Informal screening was more common than was the use of standardized tools and consisted of “a few questions about manic activity in patients with depression,” Dr. King said. Such information screening may involve questions such as, “Do you go on spending sprees? Do you stay up all night? Do you find yourself having ups and downs, including periods of high irritability, anger, or stress?”

As the use of electronic medical records becomes more widespread, they may help prompt physicians to screen patients for bipolar disorder by offering pop-up information, he said. This represents an opportunity for quality improvement.

“Physicians seem to like the idea that we could offer them quick medical information via the electronic medical record that will give them some quick answers,” he said.

The survey did not include formal interviews, but discussions with the participants have revealed that they prefer referring patients with suspected bipolar disorder to mental health specialists if screening comes up positive, Dr. King said. “Many are willing to comanage the patient, but they first want the diagnosis to be confirmed, typed according to bipolar I or II, with an identification of the phase and recommended medications.”

The study was funded by Delaware Valley Outcomes Research and GE Healthcare as part of a quality improvement project dealing with several medical disorders.

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Local Interventions Lower HbA1c, Blood Pressure

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MONTREAL — Locally designed and delivered lifestyle interventions can result in clinically meaningful improvements in patient health, according to preliminary findings from a statewide initiative aimed at decreasing health disparities.

People who live and work in a community “know the most about what might work best,” said Lauren Whetstone, Ph.D., who presented the findings in a poster at the annual meeting of the North American Primary Care Research Group.

Using a $9.2 million grant from the North Carolina Health and Wellness Trust Fund, 18 local governments and nonprofit organizations developed local interventions targeting obesity, cardiovascular disease, diabetes, and lifestyle issues in the specific communities.

Most of the communities had large African American or Native American populations that were underserved and had poor access to health care, explained Dr. Whetstone of East Carolina University, Greenville, N.C.

Some of the interventions involved health systems implementing home medical visits for diabetic patients. Other interventions involved churches establishing physical exercise and nutrition classes before Bible study.

In each community, a cohort of participants were followed longitudinally for an average of 19.5 months. Data were collected on biologic and behavioral outcomes such as blood pressure, blood glucose and cholesterol levels, dietary habits, physical activity, and smoking. Several of the communities had lay health advisers who were trained to collect some of the clinical information, or who arranged for the data to be collected by a health professional.

Each individual community had different needs, so the interventions were different and the specific measures for determining outcomes varied. However, a collective analysis of the combined data for 2,504 participants (average age 53 years) showed a positive impact.

Among 67 diabetic patients, mean hemoglobin A1c levels dropped from a baseline level of 8.9% to 8.0% by the end of the study period.

Among 203 hypertensive patients, mean systolic blood pressure dropped from a baseline of 141.62 mm Hg to 137.24 mm Hg.

Mean body mass index did not change, but data from the first half of the study period showed significant increases in self-reported daily fruit and vegetable intake (2.34 to 2.88 servings), mean days of physical activity per week (3.22 to 3.56), and mean self-rated health. There was a slight decrease in the number of current smokers (13.9% to 13.2%).

Although the study had significant limitations, including possible selection bias and lack of controls, improvements of this magnitude, if sustained, have been associated with reductions in diabetes and cardiovascular morbidity and mortality, Dr. Whetstone said.

“We've learned a lot about the differences in how organizers work within one population compared to another,” she said. For example, within the Native American population, communication and the development of trust were rooted in the tribal circle, where all community organization and business is centered.

“I think going directly to communities is going to be the way we can make the most change,” said Dr. Sally P. Weaver, director of research for the Family Health Center at the McLennan County Medical Education and Research Foundation in Waco, Tex. “Interventions need to somehow get into the broader community for people who are not seeing physicians, because I think so much of our health problems are community based with the availability of fast foods and lack of safe places to exercise.”

'I think going directly to communities is going to be the way we can make the most change.'

Source DR. WEAVER

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MONTREAL — Locally designed and delivered lifestyle interventions can result in clinically meaningful improvements in patient health, according to preliminary findings from a statewide initiative aimed at decreasing health disparities.

People who live and work in a community “know the most about what might work best,” said Lauren Whetstone, Ph.D., who presented the findings in a poster at the annual meeting of the North American Primary Care Research Group.

Using a $9.2 million grant from the North Carolina Health and Wellness Trust Fund, 18 local governments and nonprofit organizations developed local interventions targeting obesity, cardiovascular disease, diabetes, and lifestyle issues in the specific communities.

Most of the communities had large African American or Native American populations that were underserved and had poor access to health care, explained Dr. Whetstone of East Carolina University, Greenville, N.C.

Some of the interventions involved health systems implementing home medical visits for diabetic patients. Other interventions involved churches establishing physical exercise and nutrition classes before Bible study.

In each community, a cohort of participants were followed longitudinally for an average of 19.5 months. Data were collected on biologic and behavioral outcomes such as blood pressure, blood glucose and cholesterol levels, dietary habits, physical activity, and smoking. Several of the communities had lay health advisers who were trained to collect some of the clinical information, or who arranged for the data to be collected by a health professional.

Each individual community had different needs, so the interventions were different and the specific measures for determining outcomes varied. However, a collective analysis of the combined data for 2,504 participants (average age 53 years) showed a positive impact.

Among 67 diabetic patients, mean hemoglobin A1c levels dropped from a baseline level of 8.9% to 8.0% by the end of the study period.

Among 203 hypertensive patients, mean systolic blood pressure dropped from a baseline of 141.62 mm Hg to 137.24 mm Hg.

Mean body mass index did not change, but data from the first half of the study period showed significant increases in self-reported daily fruit and vegetable intake (2.34 to 2.88 servings), mean days of physical activity per week (3.22 to 3.56), and mean self-rated health. There was a slight decrease in the number of current smokers (13.9% to 13.2%).

Although the study had significant limitations, including possible selection bias and lack of controls, improvements of this magnitude, if sustained, have been associated with reductions in diabetes and cardiovascular morbidity and mortality, Dr. Whetstone said.

“We've learned a lot about the differences in how organizers work within one population compared to another,” she said. For example, within the Native American population, communication and the development of trust were rooted in the tribal circle, where all community organization and business is centered.

“I think going directly to communities is going to be the way we can make the most change,” said Dr. Sally P. Weaver, director of research for the Family Health Center at the McLennan County Medical Education and Research Foundation in Waco, Tex. “Interventions need to somehow get into the broader community for people who are not seeing physicians, because I think so much of our health problems are community based with the availability of fast foods and lack of safe places to exercise.”

'I think going directly to communities is going to be the way we can make the most change.'

Source DR. WEAVER

MONTREAL — Locally designed and delivered lifestyle interventions can result in clinically meaningful improvements in patient health, according to preliminary findings from a statewide initiative aimed at decreasing health disparities.

People who live and work in a community “know the most about what might work best,” said Lauren Whetstone, Ph.D., who presented the findings in a poster at the annual meeting of the North American Primary Care Research Group.

Using a $9.2 million grant from the North Carolina Health and Wellness Trust Fund, 18 local governments and nonprofit organizations developed local interventions targeting obesity, cardiovascular disease, diabetes, and lifestyle issues in the specific communities.

Most of the communities had large African American or Native American populations that were underserved and had poor access to health care, explained Dr. Whetstone of East Carolina University, Greenville, N.C.

Some of the interventions involved health systems implementing home medical visits for diabetic patients. Other interventions involved churches establishing physical exercise and nutrition classes before Bible study.

In each community, a cohort of participants were followed longitudinally for an average of 19.5 months. Data were collected on biologic and behavioral outcomes such as blood pressure, blood glucose and cholesterol levels, dietary habits, physical activity, and smoking. Several of the communities had lay health advisers who were trained to collect some of the clinical information, or who arranged for the data to be collected by a health professional.

Each individual community had different needs, so the interventions were different and the specific measures for determining outcomes varied. However, a collective analysis of the combined data for 2,504 participants (average age 53 years) showed a positive impact.

Among 67 diabetic patients, mean hemoglobin A1c levels dropped from a baseline level of 8.9% to 8.0% by the end of the study period.

Among 203 hypertensive patients, mean systolic blood pressure dropped from a baseline of 141.62 mm Hg to 137.24 mm Hg.

Mean body mass index did not change, but data from the first half of the study period showed significant increases in self-reported daily fruit and vegetable intake (2.34 to 2.88 servings), mean days of physical activity per week (3.22 to 3.56), and mean self-rated health. There was a slight decrease in the number of current smokers (13.9% to 13.2%).

Although the study had significant limitations, including possible selection bias and lack of controls, improvements of this magnitude, if sustained, have been associated with reductions in diabetes and cardiovascular morbidity and mortality, Dr. Whetstone said.

“We've learned a lot about the differences in how organizers work within one population compared to another,” she said. For example, within the Native American population, communication and the development of trust were rooted in the tribal circle, where all community organization and business is centered.

“I think going directly to communities is going to be the way we can make the most change,” said Dr. Sally P. Weaver, director of research for the Family Health Center at the McLennan County Medical Education and Research Foundation in Waco, Tex. “Interventions need to somehow get into the broader community for people who are not seeing physicians, because I think so much of our health problems are community based with the availability of fast foods and lack of safe places to exercise.”

'I think going directly to communities is going to be the way we can make the most change.'

Source DR. WEAVER

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Small Studies Back Injections for Tennis Elbow

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MONTREAL — Four different injection therapies appear to be effective for refractory lateral epicondylosis (tennis elbow) and offer additional treatment options for patients who have failed conservative care, suggest results of a systematic review.

“We know that 80% of these injuries get better on their own, but for the ones that don't, these injection therapies make sense,” Dr. David Rabago said at the annual meeting of the North American Primary Care Research Group.

Dr. Rabago of the University of Wisconsin, Madison, reviewed the evidence for prolotherapy, polidocanol injection, autologous whole-blood injection, and platelet-rich plasma injection therapies (Br. J. Sports Med. 2009;43:471–81).

Out of 21 possible studies, 9 studies met inclusion criteria: 5 prospective case series and 4 controlled trials. Three studies focused on prolotherapy, two on polidocanol injection, three on autologous whole-blood injection, and one on platelet-rich plasma injection.

The total number of patients in all studies combined was 201, and they ranged in age from 19 to 66 years old. Refractory elbow pain ranged anywhere from 3 to 25 months, and the follow-up periods ranged from 9 to 108 weeks.

Reduced pain was the primary outcome of each study, rated according to a visual analog scale or pain questionnaire. Improvement from baseline or compared with controls ranged from 51% to 94%, said Dr. Rabago. Secondary outcomes, which included elbow function and a decrease in abnormalities or vascularity on ultrasound, also showed improvement in all studies.

These moderate to large effect sizes were sustained over 12–25 months, and “far exceed minimal clinically relevant effect sizes for chronic pain,” said Dr. Rabago.

There were no adverse events reported.

Polidocanol is a vascular sclerosant that is injected into areas of high intratendinous blood flow in the elbow, using high-resolution ultrasound and color Doppler visualization. Its mechanism of action is believed to be the interruption of neovascular pathology, which is associated with pain and degeneration. Polidocanol is the most commonly used therapy worldwide, but is not available in the United States.

Prolotherapy also involves the injection of vascular sclerosants (most often hyperosmolar dextrose or morrhuate sodium), but does not require ultrasound guidance.

Autologous whole blood involves drawing blood from the patient and injecting it into the painful area to trigger a healing response.

Platelet-rich plasma is centrifuged from autologous whole blood and injected into the painful area to trigger healing with platelet-derived growth factors.

While prolotherapy is the easiest of the four therapies to implement, the reviewed studies showed that it required three treatment sessions, compared with the one or two sessions needed for the other therapies, Dr. Rabago noted.

With some basic training and equipment, all four therapies can be performed in a family medicine office on an outpatient basis, Dr. Rabago said in an interview.

“Each of the studies reviewed is small, and their methodological limitations prevent a consensus recommendation on the use of any of the three therapies, compared with another, at this time. However, the large effect sizes reported by all studies are compelling and suggest several areas of clinical, theoretical, and research interest,” wrote Dr. Rabago and his coauthors in their paper.

One of Dr. Rabago's coauthors is a consultant and lecturer for Harvest Technologies, a manufacturer of centrifuge and ancillary equipment for platelet-rich plasma injection therapy. Harvest had no direct or indirect role in the study. No other coauthor reported any conflict of interest.

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MONTREAL — Four different injection therapies appear to be effective for refractory lateral epicondylosis (tennis elbow) and offer additional treatment options for patients who have failed conservative care, suggest results of a systematic review.

“We know that 80% of these injuries get better on their own, but for the ones that don't, these injection therapies make sense,” Dr. David Rabago said at the annual meeting of the North American Primary Care Research Group.

Dr. Rabago of the University of Wisconsin, Madison, reviewed the evidence for prolotherapy, polidocanol injection, autologous whole-blood injection, and platelet-rich plasma injection therapies (Br. J. Sports Med. 2009;43:471–81).

Out of 21 possible studies, 9 studies met inclusion criteria: 5 prospective case series and 4 controlled trials. Three studies focused on prolotherapy, two on polidocanol injection, three on autologous whole-blood injection, and one on platelet-rich plasma injection.

The total number of patients in all studies combined was 201, and they ranged in age from 19 to 66 years old. Refractory elbow pain ranged anywhere from 3 to 25 months, and the follow-up periods ranged from 9 to 108 weeks.

Reduced pain was the primary outcome of each study, rated according to a visual analog scale or pain questionnaire. Improvement from baseline or compared with controls ranged from 51% to 94%, said Dr. Rabago. Secondary outcomes, which included elbow function and a decrease in abnormalities or vascularity on ultrasound, also showed improvement in all studies.

These moderate to large effect sizes were sustained over 12–25 months, and “far exceed minimal clinically relevant effect sizes for chronic pain,” said Dr. Rabago.

There were no adverse events reported.

Polidocanol is a vascular sclerosant that is injected into areas of high intratendinous blood flow in the elbow, using high-resolution ultrasound and color Doppler visualization. Its mechanism of action is believed to be the interruption of neovascular pathology, which is associated with pain and degeneration. Polidocanol is the most commonly used therapy worldwide, but is not available in the United States.

Prolotherapy also involves the injection of vascular sclerosants (most often hyperosmolar dextrose or morrhuate sodium), but does not require ultrasound guidance.

Autologous whole blood involves drawing blood from the patient and injecting it into the painful area to trigger a healing response.

Platelet-rich plasma is centrifuged from autologous whole blood and injected into the painful area to trigger healing with platelet-derived growth factors.

While prolotherapy is the easiest of the four therapies to implement, the reviewed studies showed that it required three treatment sessions, compared with the one or two sessions needed for the other therapies, Dr. Rabago noted.

With some basic training and equipment, all four therapies can be performed in a family medicine office on an outpatient basis, Dr. Rabago said in an interview.

“Each of the studies reviewed is small, and their methodological limitations prevent a consensus recommendation on the use of any of the three therapies, compared with another, at this time. However, the large effect sizes reported by all studies are compelling and suggest several areas of clinical, theoretical, and research interest,” wrote Dr. Rabago and his coauthors in their paper.

One of Dr. Rabago's coauthors is a consultant and lecturer for Harvest Technologies, a manufacturer of centrifuge and ancillary equipment for platelet-rich plasma injection therapy. Harvest had no direct or indirect role in the study. No other coauthor reported any conflict of interest.

MONTREAL — Four different injection therapies appear to be effective for refractory lateral epicondylosis (tennis elbow) and offer additional treatment options for patients who have failed conservative care, suggest results of a systematic review.

“We know that 80% of these injuries get better on their own, but for the ones that don't, these injection therapies make sense,” Dr. David Rabago said at the annual meeting of the North American Primary Care Research Group.

Dr. Rabago of the University of Wisconsin, Madison, reviewed the evidence for prolotherapy, polidocanol injection, autologous whole-blood injection, and platelet-rich plasma injection therapies (Br. J. Sports Med. 2009;43:471–81).

Out of 21 possible studies, 9 studies met inclusion criteria: 5 prospective case series and 4 controlled trials. Three studies focused on prolotherapy, two on polidocanol injection, three on autologous whole-blood injection, and one on platelet-rich plasma injection.

The total number of patients in all studies combined was 201, and they ranged in age from 19 to 66 years old. Refractory elbow pain ranged anywhere from 3 to 25 months, and the follow-up periods ranged from 9 to 108 weeks.

Reduced pain was the primary outcome of each study, rated according to a visual analog scale or pain questionnaire. Improvement from baseline or compared with controls ranged from 51% to 94%, said Dr. Rabago. Secondary outcomes, which included elbow function and a decrease in abnormalities or vascularity on ultrasound, also showed improvement in all studies.

These moderate to large effect sizes were sustained over 12–25 months, and “far exceed minimal clinically relevant effect sizes for chronic pain,” said Dr. Rabago.

There were no adverse events reported.

Polidocanol is a vascular sclerosant that is injected into areas of high intratendinous blood flow in the elbow, using high-resolution ultrasound and color Doppler visualization. Its mechanism of action is believed to be the interruption of neovascular pathology, which is associated with pain and degeneration. Polidocanol is the most commonly used therapy worldwide, but is not available in the United States.

Prolotherapy also involves the injection of vascular sclerosants (most often hyperosmolar dextrose or morrhuate sodium), but does not require ultrasound guidance.

Autologous whole blood involves drawing blood from the patient and injecting it into the painful area to trigger a healing response.

Platelet-rich plasma is centrifuged from autologous whole blood and injected into the painful area to trigger healing with platelet-derived growth factors.

While prolotherapy is the easiest of the four therapies to implement, the reviewed studies showed that it required three treatment sessions, compared with the one or two sessions needed for the other therapies, Dr. Rabago noted.

With some basic training and equipment, all four therapies can be performed in a family medicine office on an outpatient basis, Dr. Rabago said in an interview.

“Each of the studies reviewed is small, and their methodological limitations prevent a consensus recommendation on the use of any of the three therapies, compared with another, at this time. However, the large effect sizes reported by all studies are compelling and suggest several areas of clinical, theoretical, and research interest,” wrote Dr. Rabago and his coauthors in their paper.

One of Dr. Rabago's coauthors is a consultant and lecturer for Harvest Technologies, a manufacturer of centrifuge and ancillary equipment for platelet-rich plasma injection therapy. Harvest had no direct or indirect role in the study. No other coauthor reported any conflict of interest.

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Comorbid Depression Lifts Heart Risks for Women

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MONTREAL – In women with documented cardiovascular risk factors, those with comorbid depression have a greater risk of clinical events, compared with their nondepressed counterparts, according to findings from the Women's Ischemic Syndrome Evaluation (WISE), trial sponsored by the National Heart, Lung, and Blood Institute.

“Many studies have associated depression with an increased risk of cardiovascular disease incidence,” reported Thomas Rutledge, Ph.D., of the department of psychiatry at the University of California, San Diego. “We wanted to know whether the added presence of depression would statistically worsen the relationship between cardiac risk factors and outcome,” he said at the annual meeting of the Society of Behavioral Medicine.

Dr. Rutledge examined the association of cardiovascular disease (CVD) risk factors with actual CVD events in 153 depressed and 718 nondepressed women who were enrolled in the WISE trial. The women were a mean age of 60 years and all of them had been referred for coronary angiography.

CVD risk factors were assessed, including smoking, dyslipidemia, hypertension, obesity, diabetes, and level of physical activity. Depression was defined as self-reported current use of antidepressants to treat depression.

Over a mean follow-up period of 5.9 years, the CVD mortality rate was higher in depressed women with CVD risk factors than it was in nondepressed women with the same risk factors (11.5% vs. 9.2%, respectively). Similarly, depressed women experienced more cardiovascular events such as stroke, myocardial infarction, and heart failure (23.9% vs. 13.3%).

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MONTREAL – In women with documented cardiovascular risk factors, those with comorbid depression have a greater risk of clinical events, compared with their nondepressed counterparts, according to findings from the Women's Ischemic Syndrome Evaluation (WISE), trial sponsored by the National Heart, Lung, and Blood Institute.

“Many studies have associated depression with an increased risk of cardiovascular disease incidence,” reported Thomas Rutledge, Ph.D., of the department of psychiatry at the University of California, San Diego. “We wanted to know whether the added presence of depression would statistically worsen the relationship between cardiac risk factors and outcome,” he said at the annual meeting of the Society of Behavioral Medicine.

Dr. Rutledge examined the association of cardiovascular disease (CVD) risk factors with actual CVD events in 153 depressed and 718 nondepressed women who were enrolled in the WISE trial. The women were a mean age of 60 years and all of them had been referred for coronary angiography.

CVD risk factors were assessed, including smoking, dyslipidemia, hypertension, obesity, diabetes, and level of physical activity. Depression was defined as self-reported current use of antidepressants to treat depression.

Over a mean follow-up period of 5.9 years, the CVD mortality rate was higher in depressed women with CVD risk factors than it was in nondepressed women with the same risk factors (11.5% vs. 9.2%, respectively). Similarly, depressed women experienced more cardiovascular events such as stroke, myocardial infarction, and heart failure (23.9% vs. 13.3%).

MONTREAL – In women with documented cardiovascular risk factors, those with comorbid depression have a greater risk of clinical events, compared with their nondepressed counterparts, according to findings from the Women's Ischemic Syndrome Evaluation (WISE), trial sponsored by the National Heart, Lung, and Blood Institute.

“Many studies have associated depression with an increased risk of cardiovascular disease incidence,” reported Thomas Rutledge, Ph.D., of the department of psychiatry at the University of California, San Diego. “We wanted to know whether the added presence of depression would statistically worsen the relationship between cardiac risk factors and outcome,” he said at the annual meeting of the Society of Behavioral Medicine.

Dr. Rutledge examined the association of cardiovascular disease (CVD) risk factors with actual CVD events in 153 depressed and 718 nondepressed women who were enrolled in the WISE trial. The women were a mean age of 60 years and all of them had been referred for coronary angiography.

CVD risk factors were assessed, including smoking, dyslipidemia, hypertension, obesity, diabetes, and level of physical activity. Depression was defined as self-reported current use of antidepressants to treat depression.

Over a mean follow-up period of 5.9 years, the CVD mortality rate was higher in depressed women with CVD risk factors than it was in nondepressed women with the same risk factors (11.5% vs. 9.2%, respectively). Similarly, depressed women experienced more cardiovascular events such as stroke, myocardial infarction, and heart failure (23.9% vs. 13.3%).

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Asthma Tied to Increased Risk For Depression

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MONTREAL — Primary care patients with asthma face a significantly increased risk of developing depression, compared with the nonasthmatic population, according to a longitudinal study.

Furthermore, the combination of asthma and depression carries significantly increased mortality, reported Dr. Paul Walters of the Institute of Psychiatry, King's College, London.

Taken together, the findings suggest that it may be useful for family physicians to consider screening their asthmatic patients for depression, he said at the annual meeting of the North American Primary Care Research Group.

In a previous study, Dr. Walters and his colleagues found that asthma was the third-largest predictor of antidepressant prescriptions in the United Kingdom (Br. J. Psychiatry 2008;193:235–9).

The current longitudinal cohort study, designed to explore the association between asthma and depression, identified 11,275 asthmatic patients with no history of depression and an equal number of control subjects, matched for age and sex from the United Kingdom's General Practice Research Database.

During a 10-year follow-up period, the incidence of depression was significantly higher in the group with asthma, compared with controls (22.4 versus 13.8 per 1,000 person-years); after adjustment for age, sex, chronic illness, and smoking, the odds ratio for depression among asthmatic patients remained elevated (1.5).

Looking next at the asthmatic patients only, the researchers noted those with comorbid depression had an elevated mortality ratio (1.87), compared with those with asthma alone.

“We don't have any information on cause of death, so we're not able to say if it was due to asthma-related reasons or depression-related reasons or a combination of both,” he said.

The biggest difference between the groups was in their frequency of primary care visits (8.3 visits a year for depressed patients versus 5.3 for nondepressed patients).

Dr. Walters had no conflicts of interest to report.

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MONTREAL — Primary care patients with asthma face a significantly increased risk of developing depression, compared with the nonasthmatic population, according to a longitudinal study.

Furthermore, the combination of asthma and depression carries significantly increased mortality, reported Dr. Paul Walters of the Institute of Psychiatry, King's College, London.

Taken together, the findings suggest that it may be useful for family physicians to consider screening their asthmatic patients for depression, he said at the annual meeting of the North American Primary Care Research Group.

In a previous study, Dr. Walters and his colleagues found that asthma was the third-largest predictor of antidepressant prescriptions in the United Kingdom (Br. J. Psychiatry 2008;193:235–9).

The current longitudinal cohort study, designed to explore the association between asthma and depression, identified 11,275 asthmatic patients with no history of depression and an equal number of control subjects, matched for age and sex from the United Kingdom's General Practice Research Database.

During a 10-year follow-up period, the incidence of depression was significantly higher in the group with asthma, compared with controls (22.4 versus 13.8 per 1,000 person-years); after adjustment for age, sex, chronic illness, and smoking, the odds ratio for depression among asthmatic patients remained elevated (1.5).

Looking next at the asthmatic patients only, the researchers noted those with comorbid depression had an elevated mortality ratio (1.87), compared with those with asthma alone.

“We don't have any information on cause of death, so we're not able to say if it was due to asthma-related reasons or depression-related reasons or a combination of both,” he said.

The biggest difference between the groups was in their frequency of primary care visits (8.3 visits a year for depressed patients versus 5.3 for nondepressed patients).

Dr. Walters had no conflicts of interest to report.

MONTREAL — Primary care patients with asthma face a significantly increased risk of developing depression, compared with the nonasthmatic population, according to a longitudinal study.

Furthermore, the combination of asthma and depression carries significantly increased mortality, reported Dr. Paul Walters of the Institute of Psychiatry, King's College, London.

Taken together, the findings suggest that it may be useful for family physicians to consider screening their asthmatic patients for depression, he said at the annual meeting of the North American Primary Care Research Group.

In a previous study, Dr. Walters and his colleagues found that asthma was the third-largest predictor of antidepressant prescriptions in the United Kingdom (Br. J. Psychiatry 2008;193:235–9).

The current longitudinal cohort study, designed to explore the association between asthma and depression, identified 11,275 asthmatic patients with no history of depression and an equal number of control subjects, matched for age and sex from the United Kingdom's General Practice Research Database.

During a 10-year follow-up period, the incidence of depression was significantly higher in the group with asthma, compared with controls (22.4 versus 13.8 per 1,000 person-years); after adjustment for age, sex, chronic illness, and smoking, the odds ratio for depression among asthmatic patients remained elevated (1.5).

Looking next at the asthmatic patients only, the researchers noted those with comorbid depression had an elevated mortality ratio (1.87), compared with those with asthma alone.

“We don't have any information on cause of death, so we're not able to say if it was due to asthma-related reasons or depression-related reasons or a combination of both,” he said.

The biggest difference between the groups was in their frequency of primary care visits (8.3 visits a year for depressed patients versus 5.3 for nondepressed patients).

Dr. Walters had no conflicts of interest to report.

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