Leanne Sullivan

Patients who have severe manifestations of systemic sclerosis are seen more often in Eastern Europe than in other parts of Europe, according to a recent large database study.

However, referral bias precluded the identification of genetic or environmental factors contributing to the disease, wrote the authors.

Baseline data from the European League Against Rheumatism Scleroderma Trials and Research database were used to identify 3,661 systemic sclerosis (SSc) patients from a total of 61 European cities.

Of these, a total of 1,390 (38%) had diffuse systemic sclerosis and 2,263 (62%) had limited systemic sclerosis. The specific type of systemic sclerosis was unknown for just eight patients.

The mean age of all the patients was 55 years, and 87% were female, according to Dr. Ulrich A. Walker, of the department of rheumatology at the University of Basel (Switzerland), and his coauthors on the study.

In an attempt to identify genetic or environmental factors underlying the disease, the researchers analyzed data from 2004–2007 to discover whether there were any specific geographic differences in systemic sclerosis organ involvement as reflected by the presence of anticentromere autoantibodies and antitopoisomerase I (Scl-70).

The authors also looked for the existence of any geographic clusters of diffuse versus limited type of systemic sclerosis (Ann. Rheum. Dis. 2008 July 22 [doi:10.1136/ard.2008.091348]).

On bivariate analysis, no association was found between clinical subtype or autoantibodies and geographic location. However, one interesting finding was that there were more female patients with systemic sclerosis found in Western regions.

Additionally, Scl-70 was found more frequently in patients in Eastern Europe, the researchers said.

For partial correlations, data were adjusted for variables previously shown to determine particular organ manifestations, including autoantibody status, clinical subtype (either diffuse or limited), and the age at onset of Raynaud's phenomenon.

The association between female patients and Western European centers remained significant after adjustment for autoantibody status.

However, the link did not remain significant after subsequent adjustment for clinical subset.

“The highest correlation coefficient between disease presentations and geographical position was observed between diastolic dysfunction and longitude,” Dr. Walker and his colleagues wrote.

However, because the centers that were near each other geographically did not have similar frequencies of diastolic dysfunction, the study authors hypothesized that “such differences may be attributed to observer-dependent differences in unstandardised echocardiographic assessment.”

Cluster analysis was performed to determine if any features of systemic sclerosis were distributed in “pockets” rather than according to geographic longitude/latitude.

Within the six cities that had at least two centers with more than 15 SSc patients each (including Berlin, Madrid, Milan, Paris, Prague, and Lublin, in Poland), five of the locations showed significant within-city differences in clinical subsets and two places showed significant within-city differences in prevalence of autoantibodies. This particular finding reflected significant variation in systemic sclerosis presentation that was not explained by geographic factors.

Although geographic variations in systemic sclerosis prevalence and incidence have previously been described, variation in individual disease presentation had not been well studied, they said.

A previous study that was conducted in London found a higher prevalence of systemic sclerosis near airports.

There was also an Australian study that linked the disease with occupational exposure to silica dust.

However, the current cross-sectional study did not find a link between environment and systemic sclerosis.

The investigators also assessed referral bias by analyzing systemic sclerosis presentation and autoantibody status among centers located in the same cities or nearby.

The authors concluded that although “significant differences exist with regard to some disease presentations,” there was “no clear geographical trend with regard to key factors.”

The differences that were found to exist within cities and between those cities in close proximity are most likely explained by recruitment bias, the researchers continued.

Although the study “suggests that eastern European centres care for SSc patients with more severe manifestations than seen in other centres,” the authors added that the evident “large local variability of SSc manifestations within adjacent centres suggests a substantial referral bias and precludes the identification of genetic or environmental factors.”

The authors made no disclosures regarding any conflicts of interest.

Patients who have severe manifestations of systemic sclerosis are seen more often in Eastern Europe than in other parts of Europe, according to a recent large database study.

However, referral bias precluded the identification of genetic or environmental factors contributing to the disease, wrote the authors.

Baseline data from the European League Against Rheumatism Scleroderma Trials and Research database were used to identify 3,661 systemic sclerosis (SSc) patients from a total of 61 European cities.

Of these, a total of 1,390 (38%) had diffuse systemic sclerosis and 2,263 (62%) had limited systemic sclerosis. The specific type of systemic sclerosis was unknown for just eight patients.

The mean age of all the patients was 55 years, and 87% were female, according to Dr. Ulrich A. Walker, of the department of rheumatology at the University of Basel (Switzerland), and his coauthors on the study.

In an attempt to identify genetic or environmental factors underlying the disease, the researchers analyzed data from 2004–2007 to discover whether there were any specific geographic differences in systemic sclerosis organ involvement as reflected by the presence of anticentromere autoantibodies and antitopoisomerase I (Scl-70).

The authors also looked for the existence of any geographic clusters of diffuse versus limited type of systemic sclerosis (Ann. Rheum. Dis. 2008 July 22 [doi:10.1136/ard.2008.091348]).

On bivariate analysis, no association was found between clinical subtype or autoantibodies and geographic location. However, one interesting finding was that there were more female patients with systemic sclerosis found in Western regions.

Additionally, Scl-70 was found more frequently in patients in Eastern Europe, the researchers said.

For partial correlations, data were adjusted for variables previously shown to determine particular organ manifestations, including autoantibody status, clinical subtype (either diffuse or limited), and the age at onset of Raynaud's phenomenon.

The association between female patients and Western European centers remained significant after adjustment for autoantibody status.

However, the link did not remain significant after subsequent adjustment for clinical subset.

“The highest correlation coefficient between disease presentations and geographical position was observed between diastolic dysfunction and longitude,” Dr. Walker and his colleagues wrote.

However, because the centers that were near each other geographically did not have similar frequencies of diastolic dysfunction, the study authors hypothesized that “such differences may be attributed to observer-dependent differences in unstandardised echocardiographic assessment.”

Cluster analysis was performed to determine if any features of systemic sclerosis were distributed in “pockets” rather than according to geographic longitude/latitude.

Within the six cities that had at least two centers with more than 15 SSc patients each (including Berlin, Madrid, Milan, Paris, Prague, and Lublin, in Poland), five of the locations showed significant within-city differences in clinical subsets and two places showed significant within-city differences in prevalence of autoantibodies. This particular finding reflected significant variation in systemic sclerosis presentation that was not explained by geographic factors.

Although geographic variations in systemic sclerosis prevalence and incidence have previously been described, variation in individual disease presentation had not been well studied, they said.

A previous study that was conducted in London found a higher prevalence of systemic sclerosis near airports.

There was also an Australian study that linked the disease with occupational exposure to silica dust.

However, the current cross-sectional study did not find a link between environment and systemic sclerosis.

The investigators also assessed referral bias by analyzing systemic sclerosis presentation and autoantibody status among centers located in the same cities or nearby.

The authors concluded that although “significant differences exist with regard to some disease presentations,” there was “no clear geographical trend with regard to key factors.”

The differences that were found to exist within cities and between those cities in close proximity are most likely explained by recruitment bias, the researchers continued.

Although the study “suggests that eastern European centres care for SSc patients with more severe manifestations than seen in other centres,” the authors added that the evident “large local variability of SSc manifestations within adjacent centres suggests a substantial referral bias and precludes the identification of genetic or environmental factors.”

The authors made no disclosures regarding any conflicts of interest.

Patients who have severe manifestations of systemic sclerosis are seen more often in Eastern Europe than in other parts of Europe, according to a recent large database study.

However, referral bias precluded the identification of genetic or environmental factors contributing to the disease, wrote the authors.

Baseline data from the European League Against Rheumatism Scleroderma Trials and Research database were used to identify 3,661 systemic sclerosis (SSc) patients from a total of 61 European cities.

Of these, a total of 1,390 (38%) had diffuse systemic sclerosis and 2,263 (62%) had limited systemic sclerosis. The specific type of systemic sclerosis was unknown for just eight patients.

The mean age of all the patients was 55 years, and 87% were female, according to Dr. Ulrich A. Walker, of the department of rheumatology at the University of Basel (Switzerland), and his coauthors on the study.

In an attempt to identify genetic or environmental factors underlying the disease, the researchers analyzed data from 2004–2007 to discover whether there were any specific geographic differences in systemic sclerosis organ involvement as reflected by the presence of anticentromere autoantibodies and antitopoisomerase I (Scl-70).

The authors also looked for the existence of any geographic clusters of diffuse versus limited type of systemic sclerosis (Ann. Rheum. Dis. 2008 July 22 [doi:10.1136/ard.2008.091348]).

On bivariate analysis, no association was found between clinical subtype or autoantibodies and geographic location. However, one interesting finding was that there were more female patients with systemic sclerosis found in Western regions.

Additionally, Scl-70 was found more frequently in patients in Eastern Europe, the researchers said.

For partial correlations, data were adjusted for variables previously shown to determine particular organ manifestations, including autoantibody status, clinical subtype (either diffuse or limited), and the age at onset of Raynaud's phenomenon.

The association between female patients and Western European centers remained significant after adjustment for autoantibody status.

However, the link did not remain significant after subsequent adjustment for clinical subset.

“The highest correlation coefficient between disease presentations and geographical position was observed between diastolic dysfunction and longitude,” Dr. Walker and his colleagues wrote.

However, because the centers that were near each other geographically did not have similar frequencies of diastolic dysfunction, the study authors hypothesized that “such differences may be attributed to observer-dependent differences in unstandardised echocardiographic assessment.”

Cluster analysis was performed to determine if any features of systemic sclerosis were distributed in “pockets” rather than according to geographic longitude/latitude.

Within the six cities that had at least two centers with more than 15 SSc patients each (including Berlin, Madrid, Milan, Paris, Prague, and Lublin, in Poland), five of the locations showed significant within-city differences in clinical subsets and two places showed significant within-city differences in prevalence of autoantibodies. This particular finding reflected significant variation in systemic sclerosis presentation that was not explained by geographic factors.

Although geographic variations in systemic sclerosis prevalence and incidence have previously been described, variation in individual disease presentation had not been well studied, they said.

A previous study that was conducted in London found a higher prevalence of systemic sclerosis near airports.

There was also an Australian study that linked the disease with occupational exposure to silica dust.

However, the current cross-sectional study did not find a link between environment and systemic sclerosis.

The investigators also assessed referral bias by analyzing systemic sclerosis presentation and autoantibody status among centers located in the same cities or nearby.

The authors concluded that although “significant differences exist with regard to some disease presentations,” there was “no clear geographical trend with regard to key factors.”

The differences that were found to exist within cities and between those cities in close proximity are most likely explained by recruitment bias, the researchers continued.

Although the study “suggests that eastern European centres care for SSc patients with more severe manifestations than seen in other centres,” the authors added that the evident “large local variability of SSc manifestations within adjacent centres suggests a substantial referral bias and precludes the identification of genetic or environmental factors.”

The authors made no disclosures regarding any conflicts of interest.

An episode of infectious gastroenteritis might be a factor in the onset of inflammatory bowel disease.

Dr. Chad K. Porter and his colleagues conducted a nested case-control study to determine whether the risk of IBD was higher in patients with a documented episode of infectious gastroenteritis (IGE). Using claims data from the Defense Medical Surveillance System (the main database for U.S. military medical data), the researchers identified 3,019 active-duty military personnel with IBD who served between 1999 and 2006.

Each patient was matched for time, sex, and age with four controls from the same population who did not have IBD. The mean age for both patients and controls was 34 years, and about 82% of both groups were male. Of the IBD patients, 72% were white, compared with 64% of the controls.

To reduce the possibility that the medical visit for IGE was actually the first presentation of IBD, the IGE must have occurred 6 months prior to IBD diagnosis, based on the average time from IBD presentation to diagnosis in 266 cases selected from the data set at random. Also excluded were patients with an irritable bowel syndrome (IBS) diagnosis within 6 months before the IGE visit.

Of all IBD patients, 1,720 had a diagnosis of ulcerative colitis and 1,037 had Crohn's disease. A diagnosis of pseudopolyposis colon was considered to be IBD but was not included in the subanalyses. Patients with both ulcerative co-litis and Crohn's were included in the overall analysis but not the subanalyses.

The authors used univariate and multivariate conditional logistic regression models to evaluate the relationship between IGE and all IBD, as well as between IGE and ulcerative colitis and Crohn's disease separately.

“A previous diagnosis of infectious gastroenteritis was significantly associated with an increased odds of inflammatory bowel disease” (odds ratio, 1.40), the authors wrote (Clin. Gastroenterol. Hepatol. 2008 September [doi:10.1053/j.gastro.2008.05.081]). Patients who had experienced IGE were slightly more likely to develop Crohn's disease (OR, 1.54) than ulcerative colitis (OR, 1.36).

In addition, patients with a prior diagnosis of IBS had a fivefold increased risk of IBD, compared with those who were never diagnosed with IBS. This association “could be due to IBS-like symptoms of undiagnosed [Crohn's disease], or [because] IBS actually predisposes individuals to the development of IBD,” they wrote.

When the analysis was restricted to patients without a prior IBS diagnosis, previous IGE remained significantly associated with Crohn's disease (OR, 1.48) and ulcerative colitis (OR, 1.39). The slight difference in risk between ulcerative colitis and Crohn's patients could be due to genetic predisposition and immunopathologic triggers, Dr. Porter of the Naval Medical Research Center, Silver Spring, Md., and his colleagues said.

Race was also linked with increased risk of developing IBD: Whites had a significantly higher risk (OR, 1.44), compared with blacks, Hispanics, Asians, and others.

The authors concluded that “the risk of IBD was greater in those with a prior episode of infectious diarrhea.” They suggested that “among genetically susceptible individuals, IBD may arise subsequent to an enteric infection due to an alteration of the gut epithelial barrier resulting in exposure to commensal and/or pathogenic microflora and disturbed adaptive and innate immune responses leading to disease.”

One limitation of the study was that patients with undiagnosed IBD may be more likely to access medical care for IGE, perhaps because IGE is more severe in these patients as a result of pathophysiological changes or insufficient immune response, Dr. Porter and his colleagues said.

This study is in concordance with previous research indicating that infectious gastroenteritis might contribute to an initiation of IBD among susceptible individuals through disruption of normal gut homeostasis, they wrote.

None of the authors had a financial conflict of interest regarding their study.

An episode of infectious gastroenteritis might be a factor in the onset of inflammatory bowel disease.

Dr. Chad K. Porter and his colleagues conducted a nested case-control study to determine whether the risk of IBD was higher in patients with a documented episode of infectious gastroenteritis (IGE). Using claims data from the Defense Medical Surveillance System (the main database for U.S. military medical data), the researchers identified 3,019 active-duty military personnel with IBD who served between 1999 and 2006.

Each patient was matched for time, sex, and age with four controls from the same population who did not have IBD. The mean age for both patients and controls was 34 years, and about 82% of both groups were male. Of the IBD patients, 72% were white, compared with 64% of the controls.

To reduce the possibility that the medical visit for IGE was actually the first presentation of IBD, the IGE must have occurred 6 months prior to IBD diagnosis, based on the average time from IBD presentation to diagnosis in 266 cases selected from the data set at random. Also excluded were patients with an irritable bowel syndrome (IBS) diagnosis within 6 months before the IGE visit.

Of all IBD patients, 1,720 had a diagnosis of ulcerative colitis and 1,037 had Crohn's disease. A diagnosis of pseudopolyposis colon was considered to be IBD but was not included in the subanalyses. Patients with both ulcerative co-litis and Crohn's were included in the overall analysis but not the subanalyses.

The authors used univariate and multivariate conditional logistic regression models to evaluate the relationship between IGE and all IBD, as well as between IGE and ulcerative colitis and Crohn's disease separately.

“A previous diagnosis of infectious gastroenteritis was significantly associated with an increased odds of inflammatory bowel disease” (odds ratio, 1.40), the authors wrote (Clin. Gastroenterol. Hepatol. 2008 September [doi:10.1053/j.gastro.2008.05.081]). Patients who had experienced IGE were slightly more likely to develop Crohn's disease (OR, 1.54) than ulcerative colitis (OR, 1.36).

In addition, patients with a prior diagnosis of IBS had a fivefold increased risk of IBD, compared with those who were never diagnosed with IBS. This association “could be due to IBS-like symptoms of undiagnosed [Crohn's disease], or [because] IBS actually predisposes individuals to the development of IBD,” they wrote.

When the analysis was restricted to patients without a prior IBS diagnosis, previous IGE remained significantly associated with Crohn's disease (OR, 1.48) and ulcerative colitis (OR, 1.39). The slight difference in risk between ulcerative colitis and Crohn's patients could be due to genetic predisposition and immunopathologic triggers, Dr. Porter of the Naval Medical Research Center, Silver Spring, Md., and his colleagues said.

Race was also linked with increased risk of developing IBD: Whites had a significantly higher risk (OR, 1.44), compared with blacks, Hispanics, Asians, and others.

The authors concluded that “the risk of IBD was greater in those with a prior episode of infectious diarrhea.” They suggested that “among genetically susceptible individuals, IBD may arise subsequent to an enteric infection due to an alteration of the gut epithelial barrier resulting in exposure to commensal and/or pathogenic microflora and disturbed adaptive and innate immune responses leading to disease.”

One limitation of the study was that patients with undiagnosed IBD may be more likely to access medical care for IGE, perhaps because IGE is more severe in these patients as a result of pathophysiological changes or insufficient immune response, Dr. Porter and his colleagues said.

This study is in concordance with previous research indicating that infectious gastroenteritis might contribute to an initiation of IBD among susceptible individuals through disruption of normal gut homeostasis, they wrote.

None of the authors had a financial conflict of interest regarding their study.

An episode of infectious gastroenteritis might be a factor in the onset of inflammatory bowel disease.

Dr. Chad K. Porter and his colleagues conducted a nested case-control study to determine whether the risk of IBD was higher in patients with a documented episode of infectious gastroenteritis (IGE). Using claims data from the Defense Medical Surveillance System (the main database for U.S. military medical data), the researchers identified 3,019 active-duty military personnel with IBD who served between 1999 and 2006.

Each patient was matched for time, sex, and age with four controls from the same population who did not have IBD. The mean age for both patients and controls was 34 years, and about 82% of both groups were male. Of the IBD patients, 72% were white, compared with 64% of the controls.

To reduce the possibility that the medical visit for IGE was actually the first presentation of IBD, the IGE must have occurred 6 months prior to IBD diagnosis, based on the average time from IBD presentation to diagnosis in 266 cases selected from the data set at random. Also excluded were patients with an irritable bowel syndrome (IBS) diagnosis within 6 months before the IGE visit.

Of all IBD patients, 1,720 had a diagnosis of ulcerative colitis and 1,037 had Crohn's disease. A diagnosis of pseudopolyposis colon was considered to be IBD but was not included in the subanalyses. Patients with both ulcerative co-litis and Crohn's were included in the overall analysis but not the subanalyses.

The authors used univariate and multivariate conditional logistic regression models to evaluate the relationship between IGE and all IBD, as well as between IGE and ulcerative colitis and Crohn's disease separately.

“A previous diagnosis of infectious gastroenteritis was significantly associated with an increased odds of inflammatory bowel disease” (odds ratio, 1.40), the authors wrote (Clin. Gastroenterol. Hepatol. 2008 September [doi:10.1053/j.gastro.2008.05.081]). Patients who had experienced IGE were slightly more likely to develop Crohn's disease (OR, 1.54) than ulcerative colitis (OR, 1.36).

In addition, patients with a prior diagnosis of IBS had a fivefold increased risk of IBD, compared with those who were never diagnosed with IBS. This association “could be due to IBS-like symptoms of undiagnosed [Crohn's disease], or [because] IBS actually predisposes individuals to the development of IBD,” they wrote.

When the analysis was restricted to patients without a prior IBS diagnosis, previous IGE remained significantly associated with Crohn's disease (OR, 1.48) and ulcerative colitis (OR, 1.39). The slight difference in risk between ulcerative colitis and Crohn's patients could be due to genetic predisposition and immunopathologic triggers, Dr. Porter of the Naval Medical Research Center, Silver Spring, Md., and his colleagues said.

Race was also linked with increased risk of developing IBD: Whites had a significantly higher risk (OR, 1.44), compared with blacks, Hispanics, Asians, and others.

The authors concluded that “the risk of IBD was greater in those with a prior episode of infectious diarrhea.” They suggested that “among genetically susceptible individuals, IBD may arise subsequent to an enteric infection due to an alteration of the gut epithelial barrier resulting in exposure to commensal and/or pathogenic microflora and disturbed adaptive and innate immune responses leading to disease.”

One limitation of the study was that patients with undiagnosed IBD may be more likely to access medical care for IGE, perhaps because IGE is more severe in these patients as a result of pathophysiological changes or insufficient immune response, Dr. Porter and his colleagues said.

This study is in concordance with previous research indicating that infectious gastroenteritis might contribute to an initiation of IBD among susceptible individuals through disruption of normal gut homeostasis, they wrote.

None of the authors had a financial conflict of interest regarding their study.

Data reviewed by the Centers for Medicaid and Medicare Services to inform Medicare coverage decisions reflect significantly different populations from the Medicare population, a recent analysis has shown.

The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) reviews the literature described in a technology assessment and votes on the evidence to determine the health benefit of the procedure or device, wrote Sanket S. Dhruva and Dr. Rita F. Redberg, both of the University of California, San Francisco, which, along with the Robert Wood Johnson Foundation, provided support for the study. Dr. Redberg is a member of MedCAC, but had no financial conflicts of interest.

To examine whether the data used by MedCAC was generalizable to the Medicare population, Mr. Dhruva and Dr. Redberg looked at all six MedCAC decisions involving a cardiovascular product or service and analyzed the sample size, demographics, inclusion criteria, study location, and outcome stratification of the relevant technology assessments. The data included 141 peer-reviewed reports and 40,009 patients (Arch. Intern. Med. 2008;168:136-40).

Participants in the technology assessments had a mean age of 61 versus a mean age of 72 for Medicare beneficiaries. Several trials excluded older patients, but “the mean age in studies with explicit age exclusions (59.0 years) and those without such exclusions (61 years) did not differ,” the authors wrote. Also, overall, 75.4% were men, versus 44% of Medicare beneficiaries.

Clinical trial location also differed. Of 135 studies that reported location, 37% took place at least partly in the United States. However, most (51%) were done in Europe, 9% in Asia, and 7% in other locations. Overall, 40% of the technology assessment study participants were U.S. residents, compared with 100% of the Medicare population.

In addition, many of the trials excluded patients with renal insufficiency, arrhythmias, and diabetes.

The study concluded that the data used by MedCAC “are derived from populations that differ significantly from the Medicare beneficiary population in terms of age, sex, country of residence, and comorbid conditions.” Trial patients are “younger, healthier, male, non-U.S. populations,” with a “persistent underrepresentation of women and elderly” in clinical trials in general, the authors noted.

The authors suggested all future studies include demographic data, as “the accuracy and risk-benefit profiles of many diagnostic tests and therapies differ substantially by age and often by sex.” They also suggested the CMS require data on women and the elderly, or for the CMS to issue coverage decisions dependent on the addition of subgroup data within a specified period of time.

The population from which MedCAC draws its data differs from the Medicare population in age, sex, and health. DR. REDBERG

Data reviewed by the Centers for Medicaid and Medicare Services to inform Medicare coverage decisions reflect significantly different populations from the Medicare population, a recent analysis has shown.

The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) reviews the literature described in a technology assessment and votes on the evidence to determine the health benefit of the procedure or device, wrote Sanket S. Dhruva and Dr. Rita F. Redberg, both of the University of California, San Francisco, which, along with the Robert Wood Johnson Foundation, provided support for the study. Dr. Redberg is a member of MedCAC, but had no financial conflicts of interest.

To examine whether the data used by MedCAC was generalizable to the Medicare population, Mr. Dhruva and Dr. Redberg looked at all six MedCAC decisions involving a cardiovascular product or service and analyzed the sample size, demographics, inclusion criteria, study location, and outcome stratification of the relevant technology assessments. The data included 141 peer-reviewed reports and 40,009 patients (Arch. Intern. Med. 2008;168:136-40).

Participants in the technology assessments had a mean age of 61 versus a mean age of 72 for Medicare beneficiaries. Several trials excluded older patients, but “the mean age in studies with explicit age exclusions (59.0 years) and those without such exclusions (61 years) did not differ,” the authors wrote. Also, overall, 75.4% were men, versus 44% of Medicare beneficiaries.

Clinical trial location also differed. Of 135 studies that reported location, 37% took place at least partly in the United States. However, most (51%) were done in Europe, 9% in Asia, and 7% in other locations. Overall, 40% of the technology assessment study participants were U.S. residents, compared with 100% of the Medicare population.

In addition, many of the trials excluded patients with renal insufficiency, arrhythmias, and diabetes.

The study concluded that the data used by MedCAC “are derived from populations that differ significantly from the Medicare beneficiary population in terms of age, sex, country of residence, and comorbid conditions.” Trial patients are “younger, healthier, male, non-U.S. populations,” with a “persistent underrepresentation of women and elderly” in clinical trials in general, the authors noted.

The authors suggested all future studies include demographic data, as “the accuracy and risk-benefit profiles of many diagnostic tests and therapies differ substantially by age and often by sex.” They also suggested the CMS require data on women and the elderly, or for the CMS to issue coverage decisions dependent on the addition of subgroup data within a specified period of time.

The population from which MedCAC draws its data differs from the Medicare population in age, sex, and health. DR. REDBERG

Data reviewed by the Centers for Medicaid and Medicare Services to inform Medicare coverage decisions reflect significantly different populations from the Medicare population, a recent analysis has shown.

The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) reviews the literature described in a technology assessment and votes on the evidence to determine the health benefit of the procedure or device, wrote Sanket S. Dhruva and Dr. Rita F. Redberg, both of the University of California, San Francisco, which, along with the Robert Wood Johnson Foundation, provided support for the study. Dr. Redberg is a member of MedCAC, but had no financial conflicts of interest.

To examine whether the data used by MedCAC was generalizable to the Medicare population, Mr. Dhruva and Dr. Redberg looked at all six MedCAC decisions involving a cardiovascular product or service and analyzed the sample size, demographics, inclusion criteria, study location, and outcome stratification of the relevant technology assessments. The data included 141 peer-reviewed reports and 40,009 patients (Arch. Intern. Med. 2008;168:136-40).

Participants in the technology assessments had a mean age of 61 versus a mean age of 72 for Medicare beneficiaries. Several trials excluded older patients, but “the mean age in studies with explicit age exclusions (59.0 years) and those without such exclusions (61 years) did not differ,” the authors wrote. Also, overall, 75.4% were men, versus 44% of Medicare beneficiaries.

Clinical trial location also differed. Of 135 studies that reported location, 37% took place at least partly in the United States. However, most (51%) were done in Europe, 9% in Asia, and 7% in other locations. Overall, 40% of the technology assessment study participants were U.S. residents, compared with 100% of the Medicare population.

In addition, many of the trials excluded patients with renal insufficiency, arrhythmias, and diabetes.

The study concluded that the data used by MedCAC “are derived from populations that differ significantly from the Medicare beneficiary population in terms of age, sex, country of residence, and comorbid conditions.” Trial patients are “younger, healthier, male, non-U.S. populations,” with a “persistent underrepresentation of women and elderly” in clinical trials in general, the authors noted.

The authors suggested all future studies include demographic data, as “the accuracy and risk-benefit profiles of many diagnostic tests and therapies differ substantially by age and often by sex.” They also suggested the CMS require data on women and the elderly, or for the CMS to issue coverage decisions dependent on the addition of subgroup data within a specified period of time.

The population from which MedCAC draws its data differs from the Medicare population in age, sex, and health. DR. REDBERG

Patients with acute pancreatitis who develop a hospital-acquired infection have significantly higher mortality and health care costs, as well as longer hospital stays, compared with similar patients without infection.

Using the Cardinal Health Clinical Outcomes Research Database (a large database that tracks information on hospitalized patients), Dr. Bechien U. Wu and colleagues identified 11,046 cases of acute pancreatitis at 177 hospitals between January 2004 and January 2005. Of those, 81 patients who developed a hospital-acquired infection (HAI) were each matched with 5 similar patients who did not have a HAI.

The HAI patients and the controls were propensity matched according to their likelihood to develop an infection.

The median age was 53 years in the larger cohort, 60 years in the control patients, and 63 years in the patients with HAI. About half of the patients were men.

Mortality in the patients with HAI was 28%, compared with 11% in the 405 control patients and 1% in the overall acute pancreatitis population, according to Dr. Wu of Harvard Medical School and the division of gastroenterology at Brigham and Women's Hospital, both in Boston, and colleagues. Of the 150 deaths in the entire group of acute pancreatitis patients, 23 (15%) were in HAI patients.

Because HAI may be associated with other factors that could affect mortality, the researchers examined initial disease severity, organ failure, and invasive procedures performed in these patients. Compared with all acute pancreatitis patients, HAI patients had higher initial disease scores on the APACHE (Acute Physiology and Chronic Health Evaluation) II measure; had greater frequency of procedures that indicated organ failure, such as mechanical ventilation and hemodialysis; and more often received placement of central venous catheters and total parenteral nutrition. However, these differences were not significant when the HAI patients were compared with the control patients. Therefore, the authors concluded that the higher mortality was not the result of more severe disease in the HAI group (Clin. Gastroenterol. Hepatol. 2008 September [doi:10.1053/j.gastro.2008.05.053]).

Hospital-acquired infection was defined as “a localized or systemic infection resulting from an adverse reaction to the presence of an infectious agent(s) or its toxin(s) that was not present or incubating at the time of hospital admission,” they wrote.

One limitation was that all the infections in the study were catheter- or ventilator-associated HAI, and other types of HAI were not investigated. In this study, catheter-associated urinary tract infections accounted for 36% of HAI, catheter-associated bloodstream infections accounted for 35%, ventilator-associated pneumonia accounted for 11%, and 16% of the infections occurred at multiple sites.

Mortality was highest (33%) for the nine patients with ventilator-associated pneumonia. The 31 patients with urinary tract infections had a mortality of 27%, and the 29 patients with bloodstream infections had a mortality of 28%, they reported.

Mean length of hospital stay in the overall group was 5.6 days, compared with 13.1 days in the control acute pancreatitis patients and 34.5 days in the patients with HAI. The mean health care bill came to $28,749 in the overall group, $102,607 in control patients, and $275,580 in HAI patients. These differences were significant.

Effective methods for reducing the incidence of HAI in acute pancreatitis patients have yet to be determined. In the only two randomized, controlled studies to date, prophylactic antibiotics did not reduce extrapancreatic infection or mortality, the investigators said.

HAI is an independent contributor to worse outcomes in acute pancreatitis patients, and “aggressive efforts to reduce HAI may lead to significantly improved outcomes for patients with acute pancreatitis,” Dr. Wu and colleagues concluded.

None of the authors had a financial conflict of interest to report.

Patients with acute pancreatitis who develop a hospital-acquired infection have significantly higher mortality and health care costs, as well as longer hospital stays, compared with similar patients without infection.

Using the Cardinal Health Clinical Outcomes Research Database (a large database that tracks information on hospitalized patients), Dr. Bechien U. Wu and colleagues identified 11,046 cases of acute pancreatitis at 177 hospitals between January 2004 and January 2005. Of those, 81 patients who developed a hospital-acquired infection (HAI) were each matched with 5 similar patients who did not have a HAI.

The HAI patients and the controls were propensity matched according to their likelihood to develop an infection.

The median age was 53 years in the larger cohort, 60 years in the control patients, and 63 years in the patients with HAI. About half of the patients were men.

Mortality in the patients with HAI was 28%, compared with 11% in the 405 control patients and 1% in the overall acute pancreatitis population, according to Dr. Wu of Harvard Medical School and the division of gastroenterology at Brigham and Women's Hospital, both in Boston, and colleagues. Of the 150 deaths in the entire group of acute pancreatitis patients, 23 (15%) were in HAI patients.

Because HAI may be associated with other factors that could affect mortality, the researchers examined initial disease severity, organ failure, and invasive procedures performed in these patients. Compared with all acute pancreatitis patients, HAI patients had higher initial disease scores on the APACHE (Acute Physiology and Chronic Health Evaluation) II measure; had greater frequency of procedures that indicated organ failure, such as mechanical ventilation and hemodialysis; and more often received placement of central venous catheters and total parenteral nutrition. However, these differences were not significant when the HAI patients were compared with the control patients. Therefore, the authors concluded that the higher mortality was not the result of more severe disease in the HAI group (Clin. Gastroenterol. Hepatol. 2008 September [doi:10.1053/j.gastro.2008.05.053]).

Hospital-acquired infection was defined as “a localized or systemic infection resulting from an adverse reaction to the presence of an infectious agent(s) or its toxin(s) that was not present or incubating at the time of hospital admission,” they wrote.

One limitation was that all the infections in the study were catheter- or ventilator-associated HAI, and other types of HAI were not investigated. In this study, catheter-associated urinary tract infections accounted for 36% of HAI, catheter-associated bloodstream infections accounted for 35%, ventilator-associated pneumonia accounted for 11%, and 16% of the infections occurred at multiple sites.

Mortality was highest (33%) for the nine patients with ventilator-associated pneumonia. The 31 patients with urinary tract infections had a mortality of 27%, and the 29 patients with bloodstream infections had a mortality of 28%, they reported.

Mean length of hospital stay in the overall group was 5.6 days, compared with 13.1 days in the control acute pancreatitis patients and 34.5 days in the patients with HAI. The mean health care bill came to $28,749 in the overall group, $102,607 in control patients, and $275,580 in HAI patients. These differences were significant.

Effective methods for reducing the incidence of HAI in acute pancreatitis patients have yet to be determined. In the only two randomized, controlled studies to date, prophylactic antibiotics did not reduce extrapancreatic infection or mortality, the investigators said.

HAI is an independent contributor to worse outcomes in acute pancreatitis patients, and “aggressive efforts to reduce HAI may lead to significantly improved outcomes for patients with acute pancreatitis,” Dr. Wu and colleagues concluded.

None of the authors had a financial conflict of interest to report.

Patients with acute pancreatitis who develop a hospital-acquired infection have significantly higher mortality and health care costs, as well as longer hospital stays, compared with similar patients without infection.

Using the Cardinal Health Clinical Outcomes Research Database (a large database that tracks information on hospitalized patients), Dr. Bechien U. Wu and colleagues identified 11,046 cases of acute pancreatitis at 177 hospitals between January 2004 and January 2005. Of those, 81 patients who developed a hospital-acquired infection (HAI) were each matched with 5 similar patients who did not have a HAI.

The HAI patients and the controls were propensity matched according to their likelihood to develop an infection.

The median age was 53 years in the larger cohort, 60 years in the control patients, and 63 years in the patients with HAI. About half of the patients were men.

Mortality in the patients with HAI was 28%, compared with 11% in the 405 control patients and 1% in the overall acute pancreatitis population, according to Dr. Wu of Harvard Medical School and the division of gastroenterology at Brigham and Women's Hospital, both in Boston, and colleagues. Of the 150 deaths in the entire group of acute pancreatitis patients, 23 (15%) were in HAI patients.

Because HAI may be associated with other factors that could affect mortality, the researchers examined initial disease severity, organ failure, and invasive procedures performed in these patients. Compared with all acute pancreatitis patients, HAI patients had higher initial disease scores on the APACHE (Acute Physiology and Chronic Health Evaluation) II measure; had greater frequency of procedures that indicated organ failure, such as mechanical ventilation and hemodialysis; and more often received placement of central venous catheters and total parenteral nutrition. However, these differences were not significant when the HAI patients were compared with the control patients. Therefore, the authors concluded that the higher mortality was not the result of more severe disease in the HAI group (Clin. Gastroenterol. Hepatol. 2008 September [doi:10.1053/j.gastro.2008.05.053]).

Hospital-acquired infection was defined as “a localized or systemic infection resulting from an adverse reaction to the presence of an infectious agent(s) or its toxin(s) that was not present or incubating at the time of hospital admission,” they wrote.

One limitation was that all the infections in the study were catheter- or ventilator-associated HAI, and other types of HAI were not investigated. In this study, catheter-associated urinary tract infections accounted for 36% of HAI, catheter-associated bloodstream infections accounted for 35%, ventilator-associated pneumonia accounted for 11%, and 16% of the infections occurred at multiple sites.

Mortality was highest (33%) for the nine patients with ventilator-associated pneumonia. The 31 patients with urinary tract infections had a mortality of 27%, and the 29 patients with bloodstream infections had a mortality of 28%, they reported.

Mean length of hospital stay in the overall group was 5.6 days, compared with 13.1 days in the control acute pancreatitis patients and 34.5 days in the patients with HAI. The mean health care bill came to $28,749 in the overall group, $102,607 in control patients, and $275,580 in HAI patients. These differences were significant.

Effective methods for reducing the incidence of HAI in acute pancreatitis patients have yet to be determined. In the only two randomized, controlled studies to date, prophylactic antibiotics did not reduce extrapancreatic infection or mortality, the investigators said.

HAI is an independent contributor to worse outcomes in acute pancreatitis patients, and “aggressive efforts to reduce HAI may lead to significantly improved outcomes for patients with acute pancreatitis,” Dr. Wu and colleagues concluded.

None of the authors had a financial conflict of interest to report.

The combination of fasting and admission plasma glucose tests was a useful initial screening tool to identify diabetes in patients with acute coronary syndrome, according to a study of 140 patients admitted to a coronary care unit.

It has been shown that diabetes is underdiagnosed in ACS patients and is a strong predictor of future cardiovascular mortality, Dr. Onyebuchi E. Okosieme of Cardiff (Wales) University and colleagues wrote.

The oral glucose tolerance test (OGTT) is the preferred method for detecting diabetes, but the OGTT is expensive and time consuming, and “is underused in clinical practice,” according to the authors. However, the alternatives—fasting plasma glucose (FPG) and admission plasma glucose (APG)—alone often fail to detect diabetes after a cardiac event.

In this study, each patient (average age 67 years, 79% men) underwent all three methods of testing glucose levels, and were classified as having normal glucose tolerance, impaired glucose tolerance, or diabetes.

According to the results of the OGTT, 27% of this population (38 patients) had previously undiagnosed diabetes, 39% (54 patients) had previously undetected impaired glucose tolerance, and the remainder had normal glucose tolerance. No statistically significant differences were found among the three groups in body mass index, blood pressure, total cholesterol, and triglyceride levels.

When the results of the other testing methods were compared with those of the preferred method, the FPG had 82% sensitivity and 65% specificity in detecting diabetes, whereas the APG had 67% sensitivity and 83% specificity.

When the FPG and APG tests were combined, however, the results were 90% sensitive and 57% specific. Therefore, relying on the two tests in combination would have missed only 10% of diabetic patients and would have limited the need for OGTT testing to 52% of ACS patients, Dr. Okosieme and colleagues wrote (Diabetes Care 2008;31:1955–9).

“The combination of FPG and APG measurements was highly sensitive in identifying patients with diabetes,” they concluded. These measurements “are readily available in the acute setting and could form a useful initial screening tool.”

No conflicts of interest were mentioned.

The combination of fasting and admission plasma glucose tests was a useful initial screening tool to identify diabetes in patients with acute coronary syndrome, according to a study of 140 patients admitted to a coronary care unit.

It has been shown that diabetes is underdiagnosed in ACS patients and is a strong predictor of future cardiovascular mortality, Dr. Onyebuchi E. Okosieme of Cardiff (Wales) University and colleagues wrote.

The oral glucose tolerance test (OGTT) is the preferred method for detecting diabetes, but the OGTT is expensive and time consuming, and “is underused in clinical practice,” according to the authors. However, the alternatives—fasting plasma glucose (FPG) and admission plasma glucose (APG)—alone often fail to detect diabetes after a cardiac event.

In this study, each patient (average age 67 years, 79% men) underwent all three methods of testing glucose levels, and were classified as having normal glucose tolerance, impaired glucose tolerance, or diabetes.

According to the results of the OGTT, 27% of this population (38 patients) had previously undiagnosed diabetes, 39% (54 patients) had previously undetected impaired glucose tolerance, and the remainder had normal glucose tolerance. No statistically significant differences were found among the three groups in body mass index, blood pressure, total cholesterol, and triglyceride levels.

When the results of the other testing methods were compared with those of the preferred method, the FPG had 82% sensitivity and 65% specificity in detecting diabetes, whereas the APG had 67% sensitivity and 83% specificity.

When the FPG and APG tests were combined, however, the results were 90% sensitive and 57% specific. Therefore, relying on the two tests in combination would have missed only 10% of diabetic patients and would have limited the need for OGTT testing to 52% of ACS patients, Dr. Okosieme and colleagues wrote (Diabetes Care 2008;31:1955–9).

“The combination of FPG and APG measurements was highly sensitive in identifying patients with diabetes,” they concluded. These measurements “are readily available in the acute setting and could form a useful initial screening tool.”

No conflicts of interest were mentioned.

The combination of fasting and admission plasma glucose tests was a useful initial screening tool to identify diabetes in patients with acute coronary syndrome, according to a study of 140 patients admitted to a coronary care unit.

It has been shown that diabetes is underdiagnosed in ACS patients and is a strong predictor of future cardiovascular mortality, Dr. Onyebuchi E. Okosieme of Cardiff (Wales) University and colleagues wrote.

The oral glucose tolerance test (OGTT) is the preferred method for detecting diabetes, but the OGTT is expensive and time consuming, and “is underused in clinical practice,” according to the authors. However, the alternatives—fasting plasma glucose (FPG) and admission plasma glucose (APG)—alone often fail to detect diabetes after a cardiac event.

In this study, each patient (average age 67 years, 79% men) underwent all three methods of testing glucose levels, and were classified as having normal glucose tolerance, impaired glucose tolerance, or diabetes.

According to the results of the OGTT, 27% of this population (38 patients) had previously undiagnosed diabetes, 39% (54 patients) had previously undetected impaired glucose tolerance, and the remainder had normal glucose tolerance. No statistically significant differences were found among the three groups in body mass index, blood pressure, total cholesterol, and triglyceride levels.

When the results of the other testing methods were compared with those of the preferred method, the FPG had 82% sensitivity and 65% specificity in detecting diabetes, whereas the APG had 67% sensitivity and 83% specificity.

When the FPG and APG tests were combined, however, the results were 90% sensitive and 57% specific. Therefore, relying on the two tests in combination would have missed only 10% of diabetic patients and would have limited the need for OGTT testing to 52% of ACS patients, Dr. Okosieme and colleagues wrote (Diabetes Care 2008;31:1955–9).

“The combination of FPG and APG measurements was highly sensitive in identifying patients with diabetes,” they concluded. These measurements “are readily available in the acute setting and could form a useful initial screening tool.”

No conflicts of interest were mentioned.

WASHINGTON — More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging. Although communication skills involve "no whiz-bang drugs or procedures or devices," they can be learned, Dr. David J. Gullen said at the annual meeting of the American College of Physicians.

And these skills will be used often throughout a physician's years of practice. "We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them," he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions. Good communication also can reduce the risk of malpractice claims, said Dr. Gullen of the Mayo Clinic, Scottsdale, Ariz.

The American Academy on Communication in Healthcare (www.aachonline.org

Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after 18-23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, "about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well," he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned. Instead, after patients tell you their first complaint, ask, "Is there anything else?" To prevent making patients feel as if what they just said was unimportant, you can add, "I'm really concerned. I just want to see if you brought anything else with you."

Eliciting this information at the outset helps decrease "oh, by the way" or "doorknob" complaints that patients volunteer as the visit is ending, he added.

Relationship building is another important goal of physician-patient communication. Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, "That sounds hard," or "You look upset."

▸ Apology/acknowledgment. Show concern for the patient through comments like, "I'm sorry I'm running late today."

▸ Respect. Show appreciation for the patient's behaviors by saying things like, "You have obviously researched this problem quite well."

▸ Legitimation. Reassure patients that their feelings are appropriate: "Anyone would be confused by this situation."

▸ Support. Tell patients that you are there to help them.

'About a quarter of patients think we didn't talk about … or address the problem for which they saw us.' DR. GULLEN

WASHINGTON — More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging. Although communication skills involve "no whiz-bang drugs or procedures or devices," they can be learned, Dr. David J. Gullen said at the annual meeting of the American College of Physicians.

And these skills will be used often throughout a physician's years of practice. "We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them," he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions. Good communication also can reduce the risk of malpractice claims, said Dr. Gullen of the Mayo Clinic, Scottsdale, Ariz.

The American Academy on Communication in Healthcare (www.aachonline.org

Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after 18-23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, "about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well," he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned. Instead, after patients tell you their first complaint, ask, "Is there anything else?" To prevent making patients feel as if what they just said was unimportant, you can add, "I'm really concerned. I just want to see if you brought anything else with you."

Eliciting this information at the outset helps decrease "oh, by the way" or "doorknob" complaints that patients volunteer as the visit is ending, he added.

Relationship building is another important goal of physician-patient communication. Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, "That sounds hard," or "You look upset."

▸ Apology/acknowledgment. Show concern for the patient through comments like, "I'm sorry I'm running late today."

▸ Respect. Show appreciation for the patient's behaviors by saying things like, "You have obviously researched this problem quite well."

▸ Legitimation. Reassure patients that their feelings are appropriate: "Anyone would be confused by this situation."

▸ Support. Tell patients that you are there to help them.

'About a quarter of patients think we didn't talk about … or address the problem for which they saw us.' DR. GULLEN

WASHINGTON — More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging. Although communication skills involve "no whiz-bang drugs or procedures or devices," they can be learned, Dr. David J. Gullen said at the annual meeting of the American College of Physicians.

And these skills will be used often throughout a physician's years of practice. "We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them," he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions. Good communication also can reduce the risk of malpractice claims, said Dr. Gullen of the Mayo Clinic, Scottsdale, Ariz.

The American Academy on Communication in Healthcare (www.aachonline.org

Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after 18-23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, "about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well," he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned. Instead, after patients tell you their first complaint, ask, "Is there anything else?" To prevent making patients feel as if what they just said was unimportant, you can add, "I'm really concerned. I just want to see if you brought anything else with you."

Eliciting this information at the outset helps decrease "oh, by the way" or "doorknob" complaints that patients volunteer as the visit is ending, he added.

Relationship building is another important goal of physician-patient communication. Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, "That sounds hard," or "You look upset."

▸ Apology/acknowledgment. Show concern for the patient through comments like, "I'm sorry I'm running late today."

▸ Respect. Show appreciation for the patient's behaviors by saying things like, "You have obviously researched this problem quite well."

▸ Legitimation. Reassure patients that their feelings are appropriate: "Anyone would be confused by this situation."

▸ Support. Tell patients that you are there to help them.

'About a quarter of patients think we didn't talk about … or address the problem for which they saw us.' DR. GULLEN

More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging. Although communication skills involve “no whiz-bang drugs or procedures or devices,” they can be learned, Dr. David J. Gullen said at the annual meeting of the American College of Physicians.

And these skills will be used often throughout a physician's years of practice. “We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them,” he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions. Good communication between physician and patient also can reduce the risk of malpractice claims, said Dr. Gullen of the Mayo Clinic, Scottsdale, Ariz.

The American Academy on Communication in Healthcare (www.aachonline.org

The three main goals of the patient interview are to glean information about the patient's health status and what the patient expects from the physician that day, to build a trusting relationship between the physician and the patient, and to provide health education to the patient. Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after only 18–23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, “about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well,” he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned.

Instead, after patients tell you their first complaint, ask, “Is there anything else?” To prevent making patients feel as if what they just told you is unimportant, you can add, “I'm really concerned. I just want to see if you brought anything else with you.”

Eliciting as much information as you can at the outset helps decrease “oh, by the way” or “doorknob” complaints that patients volunteer as the visit is ending, he added.

And even if you get a “laundry list” of complaints, you may realize that several items are related and can be dealt with at one time. If there are too many issues to deal with in one day, Dr. Gullen suggested being transparent and saying something like, “I want to give you good care, so let's focus on a few things.”

Set a clear limit as to what can be accomplished in one visit, negotiate with the patient to set the agenda, and make a plan for another visit if necessary.

Active, open-ended listening can be hard work, but patients are often surprised and grateful to be listened to.

When they are done speaking, summarize what they said so that they feel heard and can correct you if you misunderstood something. Then you can bring them back to what you want to focus on, he said.

Relationship building is another important goal of physician-patient communication. It has been shown that patients tend to judge the quality of medical care on the basis of the quality of the relationship, rather than on the technical skills of the physician (Ann. Intern. Med. 2006;144:672).

Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, “That sounds hard,” or “You look upset.”

▸ Apology/acknowledgment. Show concern for the patient through comments like, “I'm sorry I'm running late today” or “I wish things were different.”

▸ Respect. Show appreciation for the patient's behaviors by saying things like, “You have obviously researched this problem quite well” or “You have obviously worked hard on this.”

▸ Legitimation. Reassure patients that their feelings are appropriate: “Anyone would be confused by this situation.”

▸ Support. Tell patients that you are there to help them.

In primary care, 'about a quarter of patients think we didn't … address the problem for which they saw us.' DR. GULLEN

More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging. Although communication skills involve “no whiz-bang drugs or procedures or devices,” they can be learned, Dr. David J. Gullen said at the annual meeting of the American College of Physicians.

And these skills will be used often throughout a physician's years of practice. “We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them,” he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions. Good communication between physician and patient also can reduce the risk of malpractice claims, said Dr. Gullen of the Mayo Clinic, Scottsdale, Ariz.

The American Academy on Communication in Healthcare (www.aachonline.org

The three main goals of the patient interview are to glean information about the patient's health status and what the patient expects from the physician that day, to build a trusting relationship between the physician and the patient, and to provide health education to the patient. Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after only 18–23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, “about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well,” he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned.

Instead, after patients tell you their first complaint, ask, “Is there anything else?” To prevent making patients feel as if what they just told you is unimportant, you can add, “I'm really concerned. I just want to see if you brought anything else with you.”

Eliciting as much information as you can at the outset helps decrease “oh, by the way” or “doorknob” complaints that patients volunteer as the visit is ending, he added.

And even if you get a “laundry list” of complaints, you may realize that several items are related and can be dealt with at one time. If there are too many issues to deal with in one day, Dr. Gullen suggested being transparent and saying something like, “I want to give you good care, so let's focus on a few things.”

Set a clear limit as to what can be accomplished in one visit, negotiate with the patient to set the agenda, and make a plan for another visit if necessary.

Active, open-ended listening can be hard work, but patients are often surprised and grateful to be listened to.

When they are done speaking, summarize what they said so that they feel heard and can correct you if you misunderstood something. Then you can bring them back to what you want to focus on, he said.

Relationship building is another important goal of physician-patient communication. It has been shown that patients tend to judge the quality of medical care on the basis of the quality of the relationship, rather than on the technical skills of the physician (Ann. Intern. Med. 2006;144:672).

Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, “That sounds hard,” or “You look upset.”

▸ Apology/acknowledgment. Show concern for the patient through comments like, “I'm sorry I'm running late today” or “I wish things were different.”

▸ Respect. Show appreciation for the patient's behaviors by saying things like, “You have obviously researched this problem quite well” or “You have obviously worked hard on this.”

▸ Legitimation. Reassure patients that their feelings are appropriate: “Anyone would be confused by this situation.”

▸ Support. Tell patients that you are there to help them.

In primary care, 'about a quarter of patients think we didn't … address the problem for which they saw us.' DR. GULLEN

More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging. Although communication skills involve “no whiz-bang drugs or procedures or devices,” they can be learned, Dr. David J. Gullen said at the annual meeting of the American College of Physicians.

And these skills will be used often throughout a physician's years of practice. “We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them,” he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions. Good communication between physician and patient also can reduce the risk of malpractice claims, said Dr. Gullen of the Mayo Clinic, Scottsdale, Ariz.

The American Academy on Communication in Healthcare (www.aachonline.org

The three main goals of the patient interview are to glean information about the patient's health status and what the patient expects from the physician that day, to build a trusting relationship between the physician and the patient, and to provide health education to the patient. Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after only 18–23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, “about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well,” he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned.

Instead, after patients tell you their first complaint, ask, “Is there anything else?” To prevent making patients feel as if what they just told you is unimportant, you can add, “I'm really concerned. I just want to see if you brought anything else with you.”

Eliciting as much information as you can at the outset helps decrease “oh, by the way” or “doorknob” complaints that patients volunteer as the visit is ending, he added.

And even if you get a “laundry list” of complaints, you may realize that several items are related and can be dealt with at one time. If there are too many issues to deal with in one day, Dr. Gullen suggested being transparent and saying something like, “I want to give you good care, so let's focus on a few things.”

Set a clear limit as to what can be accomplished in one visit, negotiate with the patient to set the agenda, and make a plan for another visit if necessary.

Active, open-ended listening can be hard work, but patients are often surprised and grateful to be listened to.

When they are done speaking, summarize what they said so that they feel heard and can correct you if you misunderstood something. Then you can bring them back to what you want to focus on, he said.

Relationship building is another important goal of physician-patient communication. It has been shown that patients tend to judge the quality of medical care on the basis of the quality of the relationship, rather than on the technical skills of the physician (Ann. Intern. Med. 2006;144:672).

Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, “That sounds hard,” or “You look upset.”

▸ Apology/acknowledgment. Show concern for the patient through comments like, “I'm sorry I'm running late today” or “I wish things were different.”

▸ Respect. Show appreciation for the patient's behaviors by saying things like, “You have obviously researched this problem quite well” or “You have obviously worked hard on this.”

▸ Legitimation. Reassure patients that their feelings are appropriate: “Anyone would be confused by this situation.”

▸ Support. Tell patients that you are there to help them.

In primary care, 'about a quarter of patients think we didn't … address the problem for which they saw us.' DR. GULLEN

More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging.

Although communication skills involve “no whiz-bang drugs or procedures or devices,” they can be learned, said Dr. David J. Gullen of the Mayo Clinic, Scottsdale, Ariz.

And once learned, these skills will be used often throughout a physician's years of practice, Dr. Gullen pointed out.

“We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them,” he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions, Dr. Gullen said at the annual meeting of the American College of Physicians.

Good communication between physician and patient also can reduce the risk of malpractice claims, he said.

The American Academy on Communication in Healthcare (www.aachonline.org

The three main goals of the patient interview are to glean information about the patient's health status and what the patient expects from the physician that day, to build a trusting relationship between the physician and the patient, and to provide health education to the patient.

Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after only 18-23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, “about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well,” he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned. Instead, after patients tell you their first complaint, ask, “Is there anything else?”

To prevent making patients feel as if what they just told you is unimportant, you can add, “I'm really concerned. I just want to see if you brought anything else with you.”

Eliciting as much information as you can at the outset helps decrease “Oh, by the way” or “doorknob” complaints that patients volunteer as the visit is ending, he added. And even if you get a “laundry list” of complaints, you may realize that several items are related and can be dealt with at one time.

If there are too many issues to deal with in one day, Dr. Gullen suggested being transparent and saying something like, “I want to give you good care, so let's focus on a few things.” Set a clear limit as to what can be accomplished in one visit, negotiate with the patient to set the agenda, and make a plan for another visit if necessary.

Active, open-ended listening can be hard work, but patients are often surprised and grateful to be listened to.

When they are done speaking, summarize what they said so that they feel heard and can correct you if you misunderstood something. Then you can bring them back to what you want to focus on, he said.

Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, “That sounds hard,” or “You look upset.”

▸ Apology/acknowledgment. Show concern for the patient through comments like, “I'm sorry I'm running late today” or “I wish things were different.”

▸ Respect. Show appreciation for the patient's behaviors by saying things like, “You have obviously researched this problem quite well” or “You have obviously worked hard on this.”

▸ Legitimation. Reassure patients that their feelings are appropriate: “Anyone would be confused by this situation.”

▸ Support. Tell patients that you are there to help them.

More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging.

Although communication skills involve “no whiz-bang drugs or procedures or devices,” they can be learned, said Dr. David J. Gullen of the Mayo Clinic, Scottsdale, Ariz.

And once learned, these skills will be used often throughout a physician's years of practice, Dr. Gullen pointed out.

“We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them,” he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions, Dr. Gullen said at the annual meeting of the American College of Physicians.

Good communication between physician and patient also can reduce the risk of malpractice claims, he said.

The American Academy on Communication in Healthcare (www.aachonline.org

The three main goals of the patient interview are to glean information about the patient's health status and what the patient expects from the physician that day, to build a trusting relationship between the physician and the patient, and to provide health education to the patient.

Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after only 18-23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, “about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well,” he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned. Instead, after patients tell you their first complaint, ask, “Is there anything else?”

To prevent making patients feel as if what they just told you is unimportant, you can add, “I'm really concerned. I just want to see if you brought anything else with you.”

Eliciting as much information as you can at the outset helps decrease “Oh, by the way” or “doorknob” complaints that patients volunteer as the visit is ending, he added. And even if you get a “laundry list” of complaints, you may realize that several items are related and can be dealt with at one time.

If there are too many issues to deal with in one day, Dr. Gullen suggested being transparent and saying something like, “I want to give you good care, so let's focus on a few things.” Set a clear limit as to what can be accomplished in one visit, negotiate with the patient to set the agenda, and make a plan for another visit if necessary.

Active, open-ended listening can be hard work, but patients are often surprised and grateful to be listened to.

When they are done speaking, summarize what they said so that they feel heard and can correct you if you misunderstood something. Then you can bring them back to what you want to focus on, he said.

Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, “That sounds hard,” or “You look upset.”

▸ Apology/acknowledgment. Show concern for the patient through comments like, “I'm sorry I'm running late today” or “I wish things were different.”

▸ Respect. Show appreciation for the patient's behaviors by saying things like, “You have obviously researched this problem quite well” or “You have obviously worked hard on this.”

▸ Legitimation. Reassure patients that their feelings are appropriate: “Anyone would be confused by this situation.”

▸ Support. Tell patients that you are there to help them.

More than a third of physicians find at least 25% of their patient interactions to be quite frustrating, and about 8% of physicians say they find at least half of their consultations frustrating.

Good communication skills can help equip physicians to cope with the patients whose behavior and personalities they find challenging.

Although communication skills involve “no whiz-bang drugs or procedures or devices,” they can be learned, said Dr. David J. Gullen of the Mayo Clinic, Scottsdale, Ariz.

And once learned, these skills will be used often throughout a physician's years of practice, Dr. Gullen pointed out.

“We estimate that in a 25-year career, we could have roughly 250,000 patient encounters. Now, that would be somebody who does a lot of outpatient work. Even if we had a very specialized, proceduralized practice … we still would spend more time talking to patients than actually operating on them,” he said.

Studies have shown that good communication can improve clinical care through better adherence to treatment plans, improved patient and physician satisfaction, better data gathering, and more appropriate medical decisions, Dr. Gullen said at the annual meeting of the American College of Physicians.

Good communication between physician and patient also can reduce the risk of malpractice claims, he said.

The American Academy on Communication in Healthcare (www.aachonline.org

The three main goals of the patient interview are to glean information about the patient's health status and what the patient expects from the physician that day, to build a trusting relationship between the physician and the patient, and to provide health education to the patient.

Information gathering involves active listening. A University of Rochester (N.Y.) study showed that, on average, doctors interrupt a patient's narrative after only 18-23 seconds. Make an effort not to interrupt for at least 1 full minute, Dr. Gullen suggested.

In primary care, “about a quarter of patients think we didn't talk about, [solve], or address the problem for which they saw us. For subspecialists, it's about the same: Maybe a third of the patients think the subspecialists either didn't address the problem or didn't explain the recommendations very well,” he said.

Patients present with an average of three to five complaints, and the first one they recount is usually not their main concern, so don't spend the entire visit on that, he cautioned. Instead, after patients tell you their first complaint, ask, “Is there anything else?”

To prevent making patients feel as if what they just told you is unimportant, you can add, “I'm really concerned. I just want to see if you brought anything else with you.”

Eliciting as much information as you can at the outset helps decrease “Oh, by the way” or “doorknob” complaints that patients volunteer as the visit is ending, he added. And even if you get a “laundry list” of complaints, you may realize that several items are related and can be dealt with at one time.

If there are too many issues to deal with in one day, Dr. Gullen suggested being transparent and saying something like, “I want to give you good care, so let's focus on a few things.” Set a clear limit as to what can be accomplished in one visit, negotiate with the patient to set the agenda, and make a plan for another visit if necessary.

Active, open-ended listening can be hard work, but patients are often surprised and grateful to be listened to.

When they are done speaking, summarize what they said so that they feel heard and can correct you if you misunderstood something. Then you can bring them back to what you want to focus on, he said.

Dr. Gullen suggested that to improve your relationship-building skills and establish the patient's trust, think of the acronym PEARLS:

▸ Partnership. This involves working with the patient to define the issues and create a treatment plan.

▸ Empathy. Understanding can be communicated to the patient through remarks such as, “That sounds hard,” or “You look upset.”

▸ Apology/acknowledgment. Show concern for the patient through comments like, “I'm sorry I'm running late today” or “I wish things were different.”

▸ Respect. Show appreciation for the patient's behaviors by saying things like, “You have obviously researched this problem quite well” or “You have obviously worked hard on this.”

▸ Legitimation. Reassure patients that their feelings are appropriate: “Anyone would be confused by this situation.”

▸ Support. Tell patients that you are there to help them.

Federal protections against genetic discrimination by insurers and employers are needed to fill in the gaps left by state legislation, according to a policy paper released by the American College of Physicians.

Only 25% of Americans trust their health insurer to not misuse their genetic information, and only 17% trust their employer, according to a 2007 survey conducted by the Johns Hopkins Genetics and Public Policy Center, Washington, cited in the paper.

This fear that genetic information will be used to deny insurance or employment might have detrimental effects, such as patients not sharing their complete medical history with their physicians, deciding to forgo genetic testing that could improve health decisions, and being reluctant to participate in research studies.

Under the provisions of HIPAA, genetic information is “protected health information” and insurers are prohibited from considering a genetic risk factor as a preexisting condition. But HIPAA does not prohibit insurers from charging a group higher premiums if one member has a known genetic risk factor, does not prohibit insurers from requiring genetic tests, and does not limit disclosure of genetic information.

State protections also are incomplete, according to the ACP, with 35 states having laws against genetic discrimination in employment and 47 states having laws against such discrimination in health insurance.

To remedy the gaps, the ACP advocates federal legislation that expressly prohibits insurers from using genetic information to deny or limit health coverage and from charging higher premiums based on genetic test results, prohibits employers from using genetic information in employment decisions, and prohibits insurers and employers from requiring genetic testing and from collecting and/or disclosing genetic information.

The organization also recommends that Congress include ERISA (Employee Retirement Income Security Act) health plans in such legislation; under ERISA, self-insured companies are exempt from state regulations.

“While they're not quite there, Congress does continue to move closer to passing federal legislation that protects the use of genetic information in employment and insurance coverage decisions,” Dr. David C. Dale, president of the ACP, said in a statement.

“This monograph is important for the ongoing discussion,” he said.

The current legislation before Congress, the Genetic Information Nondiscrimination Act (S. 358/H.R. 493), or GINA, includes many of the protections called for by the ACP, with the exception of the ERISA recommendation.

The bill passed in the House in April 2007, and a Senate vote is pending. President George W. Bush has said he would sign the bill.

If enacted, GINA would greatly expand protection against genetic discrimination by insurers and employers in the United States.

The Society for General Internal Medicine, the American Academy of Family Physicians, and the American Academy of Pediatrics are among the groups that support GINA.

The policy paper, “Establishing Federal Protections Against Genetic Discrimination,” is available on ACP's Web site at www.acponline.org/advocacy/where_we_stand/policy/gen_dis.pdf

Federal protections against genetic discrimination by insurers and employers are needed to fill in the gaps left by state legislation, according to a policy paper released by the American College of Physicians.

Only 25% of Americans trust their health insurer to not misuse their genetic information, and only 17% trust their employer, according to a 2007 survey conducted by the Johns Hopkins Genetics and Public Policy Center, Washington, cited in the paper.

This fear that genetic information will be used to deny insurance or employment might have detrimental effects, such as patients not sharing their complete medical history with their physicians, deciding to forgo genetic testing that could improve health decisions, and being reluctant to participate in research studies.

Under the provisions of HIPAA, genetic information is “protected health information” and insurers are prohibited from considering a genetic risk factor as a preexisting condition. But HIPAA does not prohibit insurers from charging a group higher premiums if one member has a known genetic risk factor, does not prohibit insurers from requiring genetic tests, and does not limit disclosure of genetic information.

State protections also are incomplete, according to the ACP, with 35 states having laws against genetic discrimination in employment and 47 states having laws against such discrimination in health insurance.

To remedy the gaps, the ACP advocates federal legislation that expressly prohibits insurers from using genetic information to deny or limit health coverage and from charging higher premiums based on genetic test results, prohibits employers from using genetic information in employment decisions, and prohibits insurers and employers from requiring genetic testing and from collecting and/or disclosing genetic information.

The organization also recommends that Congress include ERISA (Employee Retirement Income Security Act) health plans in such legislation; under ERISA, self-insured companies are exempt from state regulations.

“While they're not quite there, Congress does continue to move closer to passing federal legislation that protects the use of genetic information in employment and insurance coverage decisions,” Dr. David C. Dale, president of the ACP, said in a statement.

“This monograph is important for the ongoing discussion,” he said.

The current legislation before Congress, the Genetic Information Nondiscrimination Act (S. 358/H.R. 493), or GINA, includes many of the protections called for by the ACP, with the exception of the ERISA recommendation.

The bill passed in the House in April 2007, and a Senate vote is pending. President George W. Bush has said he would sign the bill.

If enacted, GINA would greatly expand protection against genetic discrimination by insurers and employers in the United States.

The Society for General Internal Medicine, the American Academy of Family Physicians, and the American Academy of Pediatrics are among the groups that support GINA.

The policy paper, “Establishing Federal Protections Against Genetic Discrimination,” is available on ACP's Web site at www.acponline.org/advocacy/where_we_stand/policy/gen_dis.pdf

Federal protections against genetic discrimination by insurers and employers are needed to fill in the gaps left by state legislation, according to a policy paper released by the American College of Physicians.

Only 25% of Americans trust their health insurer to not misuse their genetic information, and only 17% trust their employer, according to a 2007 survey conducted by the Johns Hopkins Genetics and Public Policy Center, Washington, cited in the paper.

This fear that genetic information will be used to deny insurance or employment might have detrimental effects, such as patients not sharing their complete medical history with their physicians, deciding to forgo genetic testing that could improve health decisions, and being reluctant to participate in research studies.

Under the provisions of HIPAA, genetic information is “protected health information” and insurers are prohibited from considering a genetic risk factor as a preexisting condition. But HIPAA does not prohibit insurers from charging a group higher premiums if one member has a known genetic risk factor, does not prohibit insurers from requiring genetic tests, and does not limit disclosure of genetic information.

State protections also are incomplete, according to the ACP, with 35 states having laws against genetic discrimination in employment and 47 states having laws against such discrimination in health insurance.

To remedy the gaps, the ACP advocates federal legislation that expressly prohibits insurers from using genetic information to deny or limit health coverage and from charging higher premiums based on genetic test results, prohibits employers from using genetic information in employment decisions, and prohibits insurers and employers from requiring genetic testing and from collecting and/or disclosing genetic information.

The organization also recommends that Congress include ERISA (Employee Retirement Income Security Act) health plans in such legislation; under ERISA, self-insured companies are exempt from state regulations.

“While they're not quite there, Congress does continue to move closer to passing federal legislation that protects the use of genetic information in employment and insurance coverage decisions,” Dr. David C. Dale, president of the ACP, said in a statement.

“This monograph is important for the ongoing discussion,” he said.

The current legislation before Congress, the Genetic Information Nondiscrimination Act (S. 358/H.R. 493), or GINA, includes many of the protections called for by the ACP, with the exception of the ERISA recommendation.

The bill passed in the House in April 2007, and a Senate vote is pending. President George W. Bush has said he would sign the bill.

If enacted, GINA would greatly expand protection against genetic discrimination by insurers and employers in the United States.

The Society for General Internal Medicine, the American Academy of Family Physicians, and the American Academy of Pediatrics are among the groups that support GINA.

The policy paper, “Establishing Federal Protections Against Genetic Discrimination,” is available on ACP's Web site at www.acponline.org/advocacy/where_we_stand/policy/gen_dis.pdf

Data reviewed by the Centers for Medicaid and Medicare Services to inform Medicare treatment coverage decisions reflect populations that are significantly different from the Medicare beneficiary population, a recent analysis has shown.

In 1998, the CMS established a panel of physicians and other professionals to review the evidence base before the agency makes national Medicare coverage decisions. The independent panel, now called the Medicare Evidence Development and Coverage Advisory Committee (MedCAC), reviews the literature described in a technology assessment and votes on the evidence to determine the health benefit of the medical procedure or device, wrote Sanket S. Dhruva and Dr. Rita F. Redberg, both of the University of California, San Francisco, which, along with the Robert Wood Johnson Foundation, provided support for the study. Dr. Redberg is a member of MedCAC, but had no financial conflicts of interest to disclose.

To examine whether the data used by MedCAC were generalizable to the Medicare population, Mr. Dhruva and Dr. Redberg looked at all six MedCAC decisions involving a cardiovascular product or service and analyzed the sample size, participant demographics, inclusion criteria, study location, and outcome stratification of the relevant technology assessments. The data in the technology assessments used for these six decisions included 141 peer-reviewed reports and 40,009 patients (Arch. Intern. Med. 2008;168:136–40).

Significant differences were found between the study and Medicare populations. Trial participants described in the technology assessments were significantly younger than were most Medicare beneficiaries (mean ages, 60.1 years and 70.8 years, respectively). Several trials excluded older patients, but “the mean age in studies with explicit age exclusions (59.0 years) and those without such exclusions (60.9 years) did not differ,” the authors wrote.

“Studies for each cardiovascular [technology assessment] also differed significantly from the Medicare population in terms of sex,” they continued. Of the study participants, 75.4% were men, compared with 43.7% of Medicare beneficiaries. Several of the studies had excluded women, but none excluded men.

Clinical trial location also was not representative of the Medicare population. Of 135 studies that reported location, 37% took place at least partly in the United States. However, most (51.1%) were done in Europe, 8.9% in Asia, and 6.7% in other locations. Overall, 40% of the technology assessment study participants were U.S. residents, compared with 100% of the Medicare population.

In addition, many of the trials excluded patients with conditions like renal insufficiency, arrhythmias, and diabetes that are common in the Medicare population.

The researchers concluded that the data used by MedCAC as evidence on which to base national treatment coverage decisions “are derived from populations that differ significantly from the Medicare beneficiary population in terms of age, sex, country of residence, and comorbid conditions.” The trial populations are “younger, healthier, male, non-U.S. populations,” reflecting a “persistent underrepresentation of women and elderly people” in clinical trials in general, the authors noted.

To improve the relevance of the data used for coverage decisions, the authors suggested that all future studies include demographic information, as “the accuracy and risk-benefit profiles of many diagnostic tests and therapies differ substantially by age and often by sex.” They also suggested that the CMS adopt a policy requiring data on women and the elderly, which would encourage trial investigators to include such data. An alternative approach would be for the CMS to issue coverage decisions dependent on the addition of subgroup data within a specified period of time.

“Closer linkage of evidence to coverage would promote better value and improved outcomes” for Medicare patients, the researchers concluded.

The clinical trial data used by CMS in its coverage decisions often underrepresented women and the elderly. DR. REDBURG

Data reviewed by the Centers for Medicaid and Medicare Services to inform Medicare treatment coverage decisions reflect populations that are significantly different from the Medicare beneficiary population, a recent analysis has shown.

In 1998, the CMS established a panel of physicians and other professionals to review the evidence base before the agency makes national Medicare coverage decisions. The independent panel, now called the Medicare Evidence Development and Coverage Advisory Committee (MedCAC), reviews the literature described in a technology assessment and votes on the evidence to determine the health benefit of the medical procedure or device, wrote Sanket S. Dhruva and Dr. Rita F. Redberg, both of the University of California, San Francisco, which, along with the Robert Wood Johnson Foundation, provided support for the study. Dr. Redberg is a member of MedCAC, but had no financial conflicts of interest to disclose.

To examine whether the data used by MedCAC were generalizable to the Medicare population, Mr. Dhruva and Dr. Redberg looked at all six MedCAC decisions involving a cardiovascular product or service and analyzed the sample size, participant demographics, inclusion criteria, study location, and outcome stratification of the relevant technology assessments. The data in the technology assessments used for these six decisions included 141 peer-reviewed reports and 40,009 patients (Arch. Intern. Med. 2008;168:136–40).

Significant differences were found between the study and Medicare populations. Trial participants described in the technology assessments were significantly younger than were most Medicare beneficiaries (mean ages, 60.1 years and 70.8 years, respectively). Several trials excluded older patients, but “the mean age in studies with explicit age exclusions (59.0 years) and those without such exclusions (60.9 years) did not differ,” the authors wrote.

“Studies for each cardiovascular [technology assessment] also differed significantly from the Medicare population in terms of sex,” they continued. Of the study participants, 75.4% were men, compared with 43.7% of Medicare beneficiaries. Several of the studies had excluded women, but none excluded men.

Clinical trial location also was not representative of the Medicare population. Of 135 studies that reported location, 37% took place at least partly in the United States. However, most (51.1%) were done in Europe, 8.9% in Asia, and 6.7% in other locations. Overall, 40% of the technology assessment study participants were U.S. residents, compared with 100% of the Medicare population.

In addition, many of the trials excluded patients with conditions like renal insufficiency, arrhythmias, and diabetes that are common in the Medicare population.

The researchers concluded that the data used by MedCAC as evidence on which to base national treatment coverage decisions “are derived from populations that differ significantly from the Medicare beneficiary population in terms of age, sex, country of residence, and comorbid conditions.” The trial populations are “younger, healthier, male, non-U.S. populations,” reflecting a “persistent underrepresentation of women and elderly people” in clinical trials in general, the authors noted.

To improve the relevance of the data used for coverage decisions, the authors suggested that all future studies include demographic information, as “the accuracy and risk-benefit profiles of many diagnostic tests and therapies differ substantially by age and often by sex.” They also suggested that the CMS adopt a policy requiring data on women and the elderly, which would encourage trial investigators to include such data. An alternative approach would be for the CMS to issue coverage decisions dependent on the addition of subgroup data within a specified period of time.

“Closer linkage of evidence to coverage would promote better value and improved outcomes” for Medicare patients, the researchers concluded.

The clinical trial data used by CMS in its coverage decisions often underrepresented women and the elderly. DR. REDBURG

Data reviewed by the Centers for Medicaid and Medicare Services to inform Medicare treatment coverage decisions reflect populations that are significantly different from the Medicare beneficiary population, a recent analysis has shown.

In 1998, the CMS established a panel of physicians and other professionals to review the evidence base before the agency makes national Medicare coverage decisions. The independent panel, now called the Medicare Evidence Development and Coverage Advisory Committee (MedCAC), reviews the literature described in a technology assessment and votes on the evidence to determine the health benefit of the medical procedure or device, wrote Sanket S. Dhruva and Dr. Rita F. Redberg, both of the University of California, San Francisco, which, along with the Robert Wood Johnson Foundation, provided support for the study. Dr. Redberg is a member of MedCAC, but had no financial conflicts of interest to disclose.

To examine whether the data used by MedCAC were generalizable to the Medicare population, Mr. Dhruva and Dr. Redberg looked at all six MedCAC decisions involving a cardiovascular product or service and analyzed the sample size, participant demographics, inclusion criteria, study location, and outcome stratification of the relevant technology assessments. The data in the technology assessments used for these six decisions included 141 peer-reviewed reports and 40,009 patients (Arch. Intern. Med. 2008;168:136–40).

Significant differences were found between the study and Medicare populations. Trial participants described in the technology assessments were significantly younger than were most Medicare beneficiaries (mean ages, 60.1 years and 70.8 years, respectively). Several trials excluded older patients, but “the mean age in studies with explicit age exclusions (59.0 years) and those without such exclusions (60.9 years) did not differ,” the authors wrote.

“Studies for each cardiovascular [technology assessment] also differed significantly from the Medicare population in terms of sex,” they continued. Of the study participants, 75.4% were men, compared with 43.7% of Medicare beneficiaries. Several of the studies had excluded women, but none excluded men.

Clinical trial location also was not representative of the Medicare population. Of 135 studies that reported location, 37% took place at least partly in the United States. However, most (51.1%) were done in Europe, 8.9% in Asia, and 6.7% in other locations. Overall, 40% of the technology assessment study participants were U.S. residents, compared with 100% of the Medicare population.

In addition, many of the trials excluded patients with conditions like renal insufficiency, arrhythmias, and diabetes that are common in the Medicare population.

The researchers concluded that the data used by MedCAC as evidence on which to base national treatment coverage decisions “are derived from populations that differ significantly from the Medicare beneficiary population in terms of age, sex, country of residence, and comorbid conditions.” The trial populations are “younger, healthier, male, non-U.S. populations,” reflecting a “persistent underrepresentation of women and elderly people” in clinical trials in general, the authors noted.

To improve the relevance of the data used for coverage decisions, the authors suggested that all future studies include demographic information, as “the accuracy and risk-benefit profiles of many diagnostic tests and therapies differ substantially by age and often by sex.” They also suggested that the CMS adopt a policy requiring data on women and the elderly, which would encourage trial investigators to include such data. An alternative approach would be for the CMS to issue coverage decisions dependent on the addition of subgroup data within a specified period of time.

“Closer linkage of evidence to coverage would promote better value and improved outcomes” for Medicare patients, the researchers concluded.

The clinical trial data used by CMS in its coverage decisions often underrepresented women and the elderly. DR. REDBURG