Kate Johnson

Montreal – Injury, heavy lifting, severe infection, or other forms of trauma were associated with the progression of psoriasis to psoriatic arthritis in a study presented at the annual meeting of the Canadian Rheumatology Association.

“All we're talking about here is an association; we can't infer causation,” said the study’s principal investigator, Dr. Dafna Gladman, in an interview.

Previous, less rigorous studies have suggested the association between trauma and psoriatic arthritis (PsA), said Dr. Gladman, professor of medicine at the University of Toronto and deputy director of the Centre for Prognosis Studies in the Rheumatic Diseases in that city.

“This study supports that notion – that environmental factors are important – but we think genetic factors are also involved,” as well as immunologic factors, she said, explaining that at most, 30% of psoriasis patients go on to develop PsA.

Her study, which was presented as a poster at the meeting, compared 159 patients who had PsA with the same number of control patients who had psoriasis alone, in order to identify risk factors for progression to PsA.

Men accounted for a similar percentage of both groups (46% in the PsA group and 44% in the controls). The mean age of participants in each group was similar (45 years and 48 years, respectively) as was the mean duration of psoriasis (17.5 years and 18.5 years, respectively). The mean duration of PsA was 3 years.

A questionnaire was administered to all patients to assess their environmental exposure over the past 10 years, including occupational trauma, infection, immunization, smoking status and history, and psychological stress.

Univariate and multivariate logistic regression analysis was used to determine the odds ratio of each exposure prior to the diagnosis of PsA.

“We actually examined all the patients with psoriasis to make sure they didn’t have psoriatic arthritis,” she said.

Univariate analysis revealed that a history of infection requiring hospitalization was the strongest risk factor for the development of PsA, with an OR of 11.7. (Infective diarrhea carried an OR of 2.11.)

The second-highest risk factor was in the category of occupational exposure. A history of work involving cumulative lifting of at least 100 lb/hr carried an OR of 2.9, and pushing cumulative loads of at least 200 lb/hr carried an OR of 1.8.

And the third-highest risk factor was any injury requiring medical attention (OR, 2.43).

Multivariate analysis revealed that injuries requiring medical attention but excluding fracture and motor vehicle accident (OR, 2.3; P = .03), occupations requiring the lifting of heavy loads (OR, 2.7; P = .002), and severe infection requiring hospitalization (OR, 10.6; P = .03) were significantly associated with progression from psoriasis to PsA.

“For exposure to immunizations we found no risk, but another group [of investigators] has found that immunization was higher in those who got arthritis,” said Dr. Gladman. “And psychological stress had no impact, although it has been reported that psoriatic patients without arthritis have a lot of stress; in fact, they may even have more because it turns out that patients with psoriasis and no arthritis actually have worse psoriasis.”

After the multifactorial analysis, smoking appeared to be associated with decreased risk, she added. Current smoking had an OR of 0.4 (P = .01), and past smoking had an OR of 0.5 (P = .04).

Dr. Gladman said that the findings are too preliminary to inform clinical recommendations at this time, but psoriasis patients should know that “if you have a job that requires a lot of lifting, you are more susceptible to getting psoriatic arthritis. Whether it’s the only factor, we don’t know, because there are also genetic factors involved. It’s quite possible that in those people who are genetically predisposed, if they also do this work, they are more likely to get arthritis.”

She said that the next step should be to look at genetic and environmental factors and see if they are independent or not.

Dr. Gladman declared no conflicts of interest.

Montreal – Injury, heavy lifting, severe infection, or other forms of trauma were associated with the progression of psoriasis to psoriatic arthritis in a study presented at the annual meeting of the Canadian Rheumatology Association.

“All we're talking about here is an association; we can't infer causation,” said the study’s principal investigator, Dr. Dafna Gladman, in an interview.

Previous, less rigorous studies have suggested the association between trauma and psoriatic arthritis (PsA), said Dr. Gladman, professor of medicine at the University of Toronto and deputy director of the Centre for Prognosis Studies in the Rheumatic Diseases in that city.

“This study supports that notion – that environmental factors are important – but we think genetic factors are also involved,” as well as immunologic factors, she said, explaining that at most, 30% of psoriasis patients go on to develop PsA.

Her study, which was presented as a poster at the meeting, compared 159 patients who had PsA with the same number of control patients who had psoriasis alone, in order to identify risk factors for progression to PsA.

Men accounted for a similar percentage of both groups (46% in the PsA group and 44% in the controls). The mean age of participants in each group was similar (45 years and 48 years, respectively) as was the mean duration of psoriasis (17.5 years and 18.5 years, respectively). The mean duration of PsA was 3 years.

A questionnaire was administered to all patients to assess their environmental exposure over the past 10 years, including occupational trauma, infection, immunization, smoking status and history, and psychological stress.

Univariate and multivariate logistic regression analysis was used to determine the odds ratio of each exposure prior to the diagnosis of PsA.

“We actually examined all the patients with psoriasis to make sure they didn’t have psoriatic arthritis,” she said.

Univariate analysis revealed that a history of infection requiring hospitalization was the strongest risk factor for the development of PsA, with an OR of 11.7. (Infective diarrhea carried an OR of 2.11.)

The second-highest risk factor was in the category of occupational exposure. A history of work involving cumulative lifting of at least 100 lb/hr carried an OR of 2.9, and pushing cumulative loads of at least 200 lb/hr carried an OR of 1.8.

And the third-highest risk factor was any injury requiring medical attention (OR, 2.43).

Multivariate analysis revealed that injuries requiring medical attention but excluding fracture and motor vehicle accident (OR, 2.3; P = .03), occupations requiring the lifting of heavy loads (OR, 2.7; P = .002), and severe infection requiring hospitalization (OR, 10.6; P = .03) were significantly associated with progression from psoriasis to PsA.

“For exposure to immunizations we found no risk, but another group [of investigators] has found that immunization was higher in those who got arthritis,” said Dr. Gladman. “And psychological stress had no impact, although it has been reported that psoriatic patients without arthritis have a lot of stress; in fact, they may even have more because it turns out that patients with psoriasis and no arthritis actually have worse psoriasis.”

After the multifactorial analysis, smoking appeared to be associated with decreased risk, she added. Current smoking had an OR of 0.4 (P = .01), and past smoking had an OR of 0.5 (P = .04).

Dr. Gladman said that the findings are too preliminary to inform clinical recommendations at this time, but psoriasis patients should know that “if you have a job that requires a lot of lifting, you are more susceptible to getting psoriatic arthritis. Whether it’s the only factor, we don’t know, because there are also genetic factors involved. It’s quite possible that in those people who are genetically predisposed, if they also do this work, they are more likely to get arthritis.”

She said that the next step should be to look at genetic and environmental factors and see if they are independent or not.

Dr. Gladman declared no conflicts of interest.

Montreal – Injury, heavy lifting, severe infection, or other forms of trauma were associated with the progression of psoriasis to psoriatic arthritis in a study presented at the annual meeting of the Canadian Rheumatology Association.

“All we're talking about here is an association; we can't infer causation,” said the study’s principal investigator, Dr. Dafna Gladman, in an interview.

Previous, less rigorous studies have suggested the association between trauma and psoriatic arthritis (PsA), said Dr. Gladman, professor of medicine at the University of Toronto and deputy director of the Centre for Prognosis Studies in the Rheumatic Diseases in that city.

“This study supports that notion – that environmental factors are important – but we think genetic factors are also involved,” as well as immunologic factors, she said, explaining that at most, 30% of psoriasis patients go on to develop PsA.

Her study, which was presented as a poster at the meeting, compared 159 patients who had PsA with the same number of control patients who had psoriasis alone, in order to identify risk factors for progression to PsA.

Men accounted for a similar percentage of both groups (46% in the PsA group and 44% in the controls). The mean age of participants in each group was similar (45 years and 48 years, respectively) as was the mean duration of psoriasis (17.5 years and 18.5 years, respectively). The mean duration of PsA was 3 years.

A questionnaire was administered to all patients to assess their environmental exposure over the past 10 years, including occupational trauma, infection, immunization, smoking status and history, and psychological stress.

Univariate and multivariate logistic regression analysis was used to determine the odds ratio of each exposure prior to the diagnosis of PsA.

“We actually examined all the patients with psoriasis to make sure they didn’t have psoriatic arthritis,” she said.

Univariate analysis revealed that a history of infection requiring hospitalization was the strongest risk factor for the development of PsA, with an OR of 11.7. (Infective diarrhea carried an OR of 2.11.)

The second-highest risk factor was in the category of occupational exposure. A history of work involving cumulative lifting of at least 100 lb/hr carried an OR of 2.9, and pushing cumulative loads of at least 200 lb/hr carried an OR of 1.8.

And the third-highest risk factor was any injury requiring medical attention (OR, 2.43).

Multivariate analysis revealed that injuries requiring medical attention but excluding fracture and motor vehicle accident (OR, 2.3; P = .03), occupations requiring the lifting of heavy loads (OR, 2.7; P = .002), and severe infection requiring hospitalization (OR, 10.6; P = .03) were significantly associated with progression from psoriasis to PsA.

“For exposure to immunizations we found no risk, but another group [of investigators] has found that immunization was higher in those who got arthritis,” said Dr. Gladman. “And psychological stress had no impact, although it has been reported that psoriatic patients without arthritis have a lot of stress; in fact, they may even have more because it turns out that patients with psoriasis and no arthritis actually have worse psoriasis.”

After the multifactorial analysis, smoking appeared to be associated with decreased risk, she added. Current smoking had an OR of 0.4 (P = .01), and past smoking had an OR of 0.5 (P = .04).

Dr. Gladman said that the findings are too preliminary to inform clinical recommendations at this time, but psoriasis patients should know that “if you have a job that requires a lot of lifting, you are more susceptible to getting psoriatic arthritis. Whether it’s the only factor, we don’t know, because there are also genetic factors involved. It’s quite possible that in those people who are genetically predisposed, if they also do this work, they are more likely to get arthritis.”

She said that the next step should be to look at genetic and environmental factors and see if they are independent or not.

Dr. Gladman declared no conflicts of interest.

Major Finding: Response rate to rituximab is highest in RA patients with elevated CRP and RF positivity.

Data Source: Post hoc analysis of data from REFLEX and SERENE trials.

Disclosures: The study was supported by Genentech Inc., F. Hoffmann-LaRoche Ltd., and Biogen Idec Inc. Dr. Faraawi reported receiving research grants from Roche, Pfizer Inc., UCB, Schering-Plough Corp., and Wyeth.

QUEBEC CITY — Baseline serologic biomarkers offer rheumatologists the possibility of tailoring rheumatoid arthritis medications to fit various subgroups of patients, thereby increasing the likelihood of achieving a good response to treatment, said Dr. Rafat Faraawi at the annual meeting of the Canadian Rheumatology Association.

In a sea of pharmaceuticals for RA, with no clear understanding of why some patients respond to one agent and not to another, biomarkers are a potential tool for predicting treatment response, Dr. Faraawi said in an interview with

“We still don't have guidelines on how to select pharmaceuticals. More or less, [the drugs] all have the same efficacy. There are minor differences, and then the selection depends on many factors.

“We depend on personal preference, physician experience, certain peculiarities of the drugs, mechanism of action,” according to Dr. Faraawi.

In a post hoc analysis of two large trials of rituximab, his group discovered that a subgroup of patients with high serum levels of C-reactive protein (CRP) as well as seropositivity for rheumatoid factor (RF) had the highest response to rituximab. “If you want to select patients who will get a response to this expensive biologic, then those with positive rheumatoid factor and an elevated C-reactive protein most likely will show a better response than [will] seronegative patients or those with low CRP.

“And if they have a combination of both, that is even better,” said Dr. Faraawi, who is a rheumatologist at McMaster University in Kitchener, Ont.

He presented the data as a poster at the meeting.

The investigators used data from REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) and SERENE (Study Evaluating Rituximab's Efficacy in Methotrexate Inadequate Responders).

Both are randomized, placebo-controlled trials of rituximab in patients with inadequate response to either tumor necrosis factor inhibitors or methotrexate, respectively (Arthritis Rheum. 2006;54:2793-806; ACR 2008, abstract 364).

Both trials reported ACR 50 response rates for rituximab, compared with placebo, after 24 weeks.

The REFLEX trial (n = 517) showed an ACR 50 response of 27% in the treated group, compared with 5% in placebo. And the SERENE trial (n = 501) showed an ACR 50 response of 26% in the treated group, compared with 9% in placebo.

For both trials, baseline levels of 19 serologic markers and 9 clinical features were recorded.

After an analysis of baseline and outcome data from both trials, Dr. Faraawi's study identified four serologic biomarkers—RF, CRP, IgG anti–cyclic citrullinated peptide 3 (CCP3) antibodies, and soluble cluster of differentiation 25 (CD25)—that were predictive of response to rituximab, he explained.

Of these, seropositivity for RF and CRP were the most predictive, and this was further enhanced when both biomarkers were presented.

For example, in the REFLEX trial, the overall ACR 50 response rate was 27% in the treated group, whereas the subgroup of patients with CRP levels above 2.9 mg/dL and positive RF of any isotope (defined as IgA RF greater than 25 U/mL, IgG RF greater than 20 U/mL, IgM RF greater than 20 U/mL, total RF greater than 20 IU/mL) had an ACR 50 response rate of 31% (placebo, 1%).

Similarly, in the SERENE trial, the overall ACR 50 response rate was 26% in the treated group, whereas the response rate was 39% in the same subgroup of patients who were positive for RF and had an elevated CRP (placebo, 7%).

Rituximab is a monoclonal antibody that selectively targets CD20-positive B cells, which secrete rheumatoid factor, said Dr. Faraawi.

“That is why, for this particular drug, patients with positive rheumatoid factor respond well. That doesn't mean this agent does not work for patients with low markers. It still works. But the likelihood of response is greater with positive markers.”

He said that large trials are needed to further clarify which markers can help in the selection of agents for specific patients.

Major Finding: Response rate to rituximab is highest in RA patients with elevated CRP and RF positivity.

Data Source: Post hoc analysis of data from REFLEX and SERENE trials.

Disclosures: The study was supported by Genentech Inc., F. Hoffmann-LaRoche Ltd., and Biogen Idec Inc. Dr. Faraawi reported receiving research grants from Roche, Pfizer Inc., UCB, Schering-Plough Corp., and Wyeth.

QUEBEC CITY — Baseline serologic biomarkers offer rheumatologists the possibility of tailoring rheumatoid arthritis medications to fit various subgroups of patients, thereby increasing the likelihood of achieving a good response to treatment, said Dr. Rafat Faraawi at the annual meeting of the Canadian Rheumatology Association.

In a sea of pharmaceuticals for RA, with no clear understanding of why some patients respond to one agent and not to another, biomarkers are a potential tool for predicting treatment response, Dr. Faraawi said in an interview with

“We still don't have guidelines on how to select pharmaceuticals. More or less, [the drugs] all have the same efficacy. There are minor differences, and then the selection depends on many factors.

“We depend on personal preference, physician experience, certain peculiarities of the drugs, mechanism of action,” according to Dr. Faraawi.

In a post hoc analysis of two large trials of rituximab, his group discovered that a subgroup of patients with high serum levels of C-reactive protein (CRP) as well as seropositivity for rheumatoid factor (RF) had the highest response to rituximab. “If you want to select patients who will get a response to this expensive biologic, then those with positive rheumatoid factor and an elevated C-reactive protein most likely will show a better response than [will] seronegative patients or those with low CRP.

“And if they have a combination of both, that is even better,” said Dr. Faraawi, who is a rheumatologist at McMaster University in Kitchener, Ont.

He presented the data as a poster at the meeting.

The investigators used data from REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) and SERENE (Study Evaluating Rituximab's Efficacy in Methotrexate Inadequate Responders).

Both are randomized, placebo-controlled trials of rituximab in patients with inadequate response to either tumor necrosis factor inhibitors or methotrexate, respectively (Arthritis Rheum. 2006;54:2793-806; ACR 2008, abstract 364).

Both trials reported ACR 50 response rates for rituximab, compared with placebo, after 24 weeks.

The REFLEX trial (n = 517) showed an ACR 50 response of 27% in the treated group, compared with 5% in placebo. And the SERENE trial (n = 501) showed an ACR 50 response of 26% in the treated group, compared with 9% in placebo.

For both trials, baseline levels of 19 serologic markers and 9 clinical features were recorded.

After an analysis of baseline and outcome data from both trials, Dr. Faraawi's study identified four serologic biomarkers—RF, CRP, IgG anti–cyclic citrullinated peptide 3 (CCP3) antibodies, and soluble cluster of differentiation 25 (CD25)—that were predictive of response to rituximab, he explained.

Of these, seropositivity for RF and CRP were the most predictive, and this was further enhanced when both biomarkers were presented.

For example, in the REFLEX trial, the overall ACR 50 response rate was 27% in the treated group, whereas the subgroup of patients with CRP levels above 2.9 mg/dL and positive RF of any isotope (defined as IgA RF greater than 25 U/mL, IgG RF greater than 20 U/mL, IgM RF greater than 20 U/mL, total RF greater than 20 IU/mL) had an ACR 50 response rate of 31% (placebo, 1%).

Similarly, in the SERENE trial, the overall ACR 50 response rate was 26% in the treated group, whereas the response rate was 39% in the same subgroup of patients who were positive for RF and had an elevated CRP (placebo, 7%).

Rituximab is a monoclonal antibody that selectively targets CD20-positive B cells, which secrete rheumatoid factor, said Dr. Faraawi.

“That is why, for this particular drug, patients with positive rheumatoid factor respond well. That doesn't mean this agent does not work for patients with low markers. It still works. But the likelihood of response is greater with positive markers.”

He said that large trials are needed to further clarify which markers can help in the selection of agents for specific patients.

Major Finding: Response rate to rituximab is highest in RA patients with elevated CRP and RF positivity.

Data Source: Post hoc analysis of data from REFLEX and SERENE trials.

Disclosures: The study was supported by Genentech Inc., F. Hoffmann-LaRoche Ltd., and Biogen Idec Inc. Dr. Faraawi reported receiving research grants from Roche, Pfizer Inc., UCB, Schering-Plough Corp., and Wyeth.

QUEBEC CITY — Baseline serologic biomarkers offer rheumatologists the possibility of tailoring rheumatoid arthritis medications to fit various subgroups of patients, thereby increasing the likelihood of achieving a good response to treatment, said Dr. Rafat Faraawi at the annual meeting of the Canadian Rheumatology Association.

In a sea of pharmaceuticals for RA, with no clear understanding of why some patients respond to one agent and not to another, biomarkers are a potential tool for predicting treatment response, Dr. Faraawi said in an interview with

“We still don't have guidelines on how to select pharmaceuticals. More or less, [the drugs] all have the same efficacy. There are minor differences, and then the selection depends on many factors.

“We depend on personal preference, physician experience, certain peculiarities of the drugs, mechanism of action,” according to Dr. Faraawi.

In a post hoc analysis of two large trials of rituximab, his group discovered that a subgroup of patients with high serum levels of C-reactive protein (CRP) as well as seropositivity for rheumatoid factor (RF) had the highest response to rituximab. “If you want to select patients who will get a response to this expensive biologic, then those with positive rheumatoid factor and an elevated C-reactive protein most likely will show a better response than [will] seronegative patients or those with low CRP.

“And if they have a combination of both, that is even better,” said Dr. Faraawi, who is a rheumatologist at McMaster University in Kitchener, Ont.

He presented the data as a poster at the meeting.

The investigators used data from REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) and SERENE (Study Evaluating Rituximab's Efficacy in Methotrexate Inadequate Responders).

Both are randomized, placebo-controlled trials of rituximab in patients with inadequate response to either tumor necrosis factor inhibitors or methotrexate, respectively (Arthritis Rheum. 2006;54:2793-806; ACR 2008, abstract 364).

Both trials reported ACR 50 response rates for rituximab, compared with placebo, after 24 weeks.

The REFLEX trial (n = 517) showed an ACR 50 response of 27% in the treated group, compared with 5% in placebo. And the SERENE trial (n = 501) showed an ACR 50 response of 26% in the treated group, compared with 9% in placebo.

For both trials, baseline levels of 19 serologic markers and 9 clinical features were recorded.

After an analysis of baseline and outcome data from both trials, Dr. Faraawi's study identified four serologic biomarkers—RF, CRP, IgG anti–cyclic citrullinated peptide 3 (CCP3) antibodies, and soluble cluster of differentiation 25 (CD25)—that were predictive of response to rituximab, he explained.

Of these, seropositivity for RF and CRP were the most predictive, and this was further enhanced when both biomarkers were presented.

For example, in the REFLEX trial, the overall ACR 50 response rate was 27% in the treated group, whereas the subgroup of patients with CRP levels above 2.9 mg/dL and positive RF of any isotope (defined as IgA RF greater than 25 U/mL, IgG RF greater than 20 U/mL, IgM RF greater than 20 U/mL, total RF greater than 20 IU/mL) had an ACR 50 response rate of 31% (placebo, 1%).

Similarly, in the SERENE trial, the overall ACR 50 response rate was 26% in the treated group, whereas the response rate was 39% in the same subgroup of patients who were positive for RF and had an elevated CRP (placebo, 7%).

Rituximab is a monoclonal antibody that selectively targets CD20-positive B cells, which secrete rheumatoid factor, said Dr. Faraawi.

“That is why, for this particular drug, patients with positive rheumatoid factor respond well. That doesn't mean this agent does not work for patients with low markers. It still works. But the likelihood of response is greater with positive markers.”

He said that large trials are needed to further clarify which markers can help in the selection of agents for specific patients.

QUEBEC CITY — The increased rate of serious infections seen in patients with rheumatoid arthritis is most strongly associated with current glucocorticoid exposure, but comorbidities are also an important factor, according to findings from a large, nested, case-control study presented at the annual meeting of the Canadian Rheumatology Association.

“When we try to predict risk of infection, we tend to focus on the drugs, particularly the immunosuppressive agents,” said principal investigator Dr. Claire Bombardier in an interview. The findings from this research show that rheumatologists need to pay more attention to other, heretofore largely overlooked risk factors, she added.

Dr. Bombardier noted her study's serious flaw: It relies on data from a source that does not include complete information on exposure to biologic agents. Use of biologics has been linked to an increased risk for reactivation of tuberculosis as well as primary fungal and other infections.

In two separate posters, Dr. Bombardier presented a retrospective examination of serious infections requiring hospitalization, as well as serious fungal infections, in a cohort of 81,497 seniors with RA.

All subjects were aged older than 65 years (mean, 69 years), and were drawn from the Ontario Biologics Research Initiative administrative database, said Dr. Bombardier, professor of medicine and director of the division of rheumatology at the University of Toronto.

The first study involved a total of 14,214 subjects with serious infection requiring hospitalization in 1992-2006, with the most common infection being pneumonia (n = 7,026). These subjects were matched to controls from the same cohort according to age, sex, and year of cohort entry. Multivariate logistic regression analysis was used to assess the independent effects of demographics (age, income, rural/urban residence); comorbidity (based on the Charlson-Deyo comorbidity index); markers of RA severity (number of rheumatology visits, history of joint replacement, presence of extra-articular RA, and prescription NSAID use); and RA-related drug exposure. Past and current drug exposures were determined based on electronic provincial prescription data, although most biologic use was probably not captured in this database because it is not covered by provincial health insurance.

After adjustment, the study found that current use of glucocorticoids was associated with the highest risk of infection, and that this risk increased with increasing doses. Compared with no exposure, a glucocorticoid dose of 5 mg or less per day was associated with an odds ratio of infection of 3.81. At 6-9 mg/day, the OR was 4.56, rising to 5.58 at a dose of 10-19 mg/day, and the OR was 5.46 at a dose of 20 mg or more per day.

But other drugs—both biologics (to the extent their effect was assessed) and disease-modifying antirheumatic drugs—were also associated with risk, although less so, with ORs ranging from 1.1 to 3.64, said Dr. Bombardier. Within the context of these nonglucocorticoid drugs, comorbidity and markers of disease severity were associated with a similar range of risks of infection. Chronic lung disease was associated with an OR of 1.47, and renal disease with OR of 1.38. The Charlson-Deyo comorbidity index score of 1 had an OR of 1.44, whereas a score of 2 or more had an OR of 1.59.

In terms of markers of disease activity, the presence of one or more extra-articular feature of RA was associated with an OR of 1.14, and a history of joint replacement with an OR of 1.05.

Dr. Bombardier's second study focused specifically on the risk of serious fungal infections within the same cohort, because of “the flurry of interest in fungal infections recently,” she said.

A total of 53 serious fungal infections occurred within the cohort, including aspergillosis, coccidioidomycosis, histoplasmosis, blastomycosis, paracoccidioidomycosis, and systemic candidiasis. As with the previous study, cases of infection were matched to 265 controls from the same cohort.

Again, univariate and multivariate logistic regression analysis assessed the independent effects of demographics, comorbidity, markers of RA severity, and RA-related drug exposure.

After adjustment, the study found that cases were more likely than controls to live in rural areas (OR, 6.8) and to have more comorbidity, most commonly lung (OR, 1.27) and renal disease (OR, 1.95).

Compared with no prednisone, there was a greater risk of fungal infection associated with prednisone doses of 10-19 mg/day (OR, 1.90) and more than 20 mg/day (OR, 4.0).

Only 17 of 53 cases were currently exposed to a DMARD at the time of the fungal infection, and no case was currently exposed to a biologic agent.

Compared with no exposure, a higher risk of infection was associated with current exposure to sulfasalazine (OR, 1.90), methotrexate (OR, 1.66), and hydroxychloroquine (OR, 1.64).

Dr. Bombardier said this information should help physicians refine decision making about adjusting RA patients' medication dose.

“When you're worrying about a patient, don't focus just on the drugs. Think about whether they have renal disease, or whether they have lung disease. That is as important [as], if not more important than, worrying about the drugs,” she said.

Disclosures: Funding for the study was provided by the Canadian Institute of Health Research and the Ontario Ministry of Health and Long-Term Care. Dr. Bombardier holds a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care.

QUEBEC CITY — The increased rate of serious infections seen in patients with rheumatoid arthritis is most strongly associated with current glucocorticoid exposure, but comorbidities are also an important factor, according to findings from a large, nested, case-control study presented at the annual meeting of the Canadian Rheumatology Association.

“When we try to predict risk of infection, we tend to focus on the drugs, particularly the immunosuppressive agents,” said principal investigator Dr. Claire Bombardier in an interview. The findings from this research show that rheumatologists need to pay more attention to other, heretofore largely overlooked risk factors, she added.

Dr. Bombardier noted her study's serious flaw: It relies on data from a source that does not include complete information on exposure to biologic agents. Use of biologics has been linked to an increased risk for reactivation of tuberculosis as well as primary fungal and other infections.

In two separate posters, Dr. Bombardier presented a retrospective examination of serious infections requiring hospitalization, as well as serious fungal infections, in a cohort of 81,497 seniors with RA.

All subjects were aged older than 65 years (mean, 69 years), and were drawn from the Ontario Biologics Research Initiative administrative database, said Dr. Bombardier, professor of medicine and director of the division of rheumatology at the University of Toronto.

The first study involved a total of 14,214 subjects with serious infection requiring hospitalization in 1992-2006, with the most common infection being pneumonia (n = 7,026). These subjects were matched to controls from the same cohort according to age, sex, and year of cohort entry. Multivariate logistic regression analysis was used to assess the independent effects of demographics (age, income, rural/urban residence); comorbidity (based on the Charlson-Deyo comorbidity index); markers of RA severity (number of rheumatology visits, history of joint replacement, presence of extra-articular RA, and prescription NSAID use); and RA-related drug exposure. Past and current drug exposures were determined based on electronic provincial prescription data, although most biologic use was probably not captured in this database because it is not covered by provincial health insurance.

After adjustment, the study found that current use of glucocorticoids was associated with the highest risk of infection, and that this risk increased with increasing doses. Compared with no exposure, a glucocorticoid dose of 5 mg or less per day was associated with an odds ratio of infection of 3.81. At 6-9 mg/day, the OR was 4.56, rising to 5.58 at a dose of 10-19 mg/day, and the OR was 5.46 at a dose of 20 mg or more per day.

But other drugs—both biologics (to the extent their effect was assessed) and disease-modifying antirheumatic drugs—were also associated with risk, although less so, with ORs ranging from 1.1 to 3.64, said Dr. Bombardier. Within the context of these nonglucocorticoid drugs, comorbidity and markers of disease severity were associated with a similar range of risks of infection. Chronic lung disease was associated with an OR of 1.47, and renal disease with OR of 1.38. The Charlson-Deyo comorbidity index score of 1 had an OR of 1.44, whereas a score of 2 or more had an OR of 1.59.

In terms of markers of disease activity, the presence of one or more extra-articular feature of RA was associated with an OR of 1.14, and a history of joint replacement with an OR of 1.05.

Dr. Bombardier's second study focused specifically on the risk of serious fungal infections within the same cohort, because of “the flurry of interest in fungal infections recently,” she said.

A total of 53 serious fungal infections occurred within the cohort, including aspergillosis, coccidioidomycosis, histoplasmosis, blastomycosis, paracoccidioidomycosis, and systemic candidiasis. As with the previous study, cases of infection were matched to 265 controls from the same cohort.

Again, univariate and multivariate logistic regression analysis assessed the independent effects of demographics, comorbidity, markers of RA severity, and RA-related drug exposure.

After adjustment, the study found that cases were more likely than controls to live in rural areas (OR, 6.8) and to have more comorbidity, most commonly lung (OR, 1.27) and renal disease (OR, 1.95).

Compared with no prednisone, there was a greater risk of fungal infection associated with prednisone doses of 10-19 mg/day (OR, 1.90) and more than 20 mg/day (OR, 4.0).

Only 17 of 53 cases were currently exposed to a DMARD at the time of the fungal infection, and no case was currently exposed to a biologic agent.

Compared with no exposure, a higher risk of infection was associated with current exposure to sulfasalazine (OR, 1.90), methotrexate (OR, 1.66), and hydroxychloroquine (OR, 1.64).

Dr. Bombardier said this information should help physicians refine decision making about adjusting RA patients' medication dose.

“When you're worrying about a patient, don't focus just on the drugs. Think about whether they have renal disease, or whether they have lung disease. That is as important [as], if not more important than, worrying about the drugs,” she said.

Disclosures: Funding for the study was provided by the Canadian Institute of Health Research and the Ontario Ministry of Health and Long-Term Care. Dr. Bombardier holds a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care.

QUEBEC CITY — The increased rate of serious infections seen in patients with rheumatoid arthritis is most strongly associated with current glucocorticoid exposure, but comorbidities are also an important factor, according to findings from a large, nested, case-control study presented at the annual meeting of the Canadian Rheumatology Association.

“When we try to predict risk of infection, we tend to focus on the drugs, particularly the immunosuppressive agents,” said principal investigator Dr. Claire Bombardier in an interview. The findings from this research show that rheumatologists need to pay more attention to other, heretofore largely overlooked risk factors, she added.

Dr. Bombardier noted her study's serious flaw: It relies on data from a source that does not include complete information on exposure to biologic agents. Use of biologics has been linked to an increased risk for reactivation of tuberculosis as well as primary fungal and other infections.

In two separate posters, Dr. Bombardier presented a retrospective examination of serious infections requiring hospitalization, as well as serious fungal infections, in a cohort of 81,497 seniors with RA.

All subjects were aged older than 65 years (mean, 69 years), and were drawn from the Ontario Biologics Research Initiative administrative database, said Dr. Bombardier, professor of medicine and director of the division of rheumatology at the University of Toronto.

The first study involved a total of 14,214 subjects with serious infection requiring hospitalization in 1992-2006, with the most common infection being pneumonia (n = 7,026). These subjects were matched to controls from the same cohort according to age, sex, and year of cohort entry. Multivariate logistic regression analysis was used to assess the independent effects of demographics (age, income, rural/urban residence); comorbidity (based on the Charlson-Deyo comorbidity index); markers of RA severity (number of rheumatology visits, history of joint replacement, presence of extra-articular RA, and prescription NSAID use); and RA-related drug exposure. Past and current drug exposures were determined based on electronic provincial prescription data, although most biologic use was probably not captured in this database because it is not covered by provincial health insurance.

After adjustment, the study found that current use of glucocorticoids was associated with the highest risk of infection, and that this risk increased with increasing doses. Compared with no exposure, a glucocorticoid dose of 5 mg or less per day was associated with an odds ratio of infection of 3.81. At 6-9 mg/day, the OR was 4.56, rising to 5.58 at a dose of 10-19 mg/day, and the OR was 5.46 at a dose of 20 mg or more per day.

But other drugs—both biologics (to the extent their effect was assessed) and disease-modifying antirheumatic drugs—were also associated with risk, although less so, with ORs ranging from 1.1 to 3.64, said Dr. Bombardier. Within the context of these nonglucocorticoid drugs, comorbidity and markers of disease severity were associated with a similar range of risks of infection. Chronic lung disease was associated with an OR of 1.47, and renal disease with OR of 1.38. The Charlson-Deyo comorbidity index score of 1 had an OR of 1.44, whereas a score of 2 or more had an OR of 1.59.

In terms of markers of disease activity, the presence of one or more extra-articular feature of RA was associated with an OR of 1.14, and a history of joint replacement with an OR of 1.05.

Dr. Bombardier's second study focused specifically on the risk of serious fungal infections within the same cohort, because of “the flurry of interest in fungal infections recently,” she said.

A total of 53 serious fungal infections occurred within the cohort, including aspergillosis, coccidioidomycosis, histoplasmosis, blastomycosis, paracoccidioidomycosis, and systemic candidiasis. As with the previous study, cases of infection were matched to 265 controls from the same cohort.

Again, univariate and multivariate logistic regression analysis assessed the independent effects of demographics, comorbidity, markers of RA severity, and RA-related drug exposure.

After adjustment, the study found that cases were more likely than controls to live in rural areas (OR, 6.8) and to have more comorbidity, most commonly lung (OR, 1.27) and renal disease (OR, 1.95).

Compared with no prednisone, there was a greater risk of fungal infection associated with prednisone doses of 10-19 mg/day (OR, 1.90) and more than 20 mg/day (OR, 4.0).

Only 17 of 53 cases were currently exposed to a DMARD at the time of the fungal infection, and no case was currently exposed to a biologic agent.

Compared with no exposure, a higher risk of infection was associated with current exposure to sulfasalazine (OR, 1.90), methotrexate (OR, 1.66), and hydroxychloroquine (OR, 1.64).

Dr. Bombardier said this information should help physicians refine decision making about adjusting RA patients' medication dose.

“When you're worrying about a patient, don't focus just on the drugs. Think about whether they have renal disease, or whether they have lung disease. That is as important [as], if not more important than, worrying about the drugs,” she said.

Disclosures: Funding for the study was provided by the Canadian Institute of Health Research and the Ontario Ministry of Health and Long-Term Care. Dr. Bombardier holds a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care.

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.

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.

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.

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.

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.”

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.”

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.

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.

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 A_1c 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 A_1c 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 A_1c 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 — 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.

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 — 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 A_1c 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 A_1c 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 A_1c 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