Jane Neff Rollins

LOS ANGELES — Older African Americans distrust clinical research significantly more than do older whites, according to results of a mail survey presented by Dr. Raegan W. Durant at the annual meeting of the Society of General Internal Medicine.

The study was designed to determine whether African Americans' distrust of clinical research arises from attitudes toward physicians and the health care system in general, or from their relationships with individual physicians.

The investigators conducted a mail survey of 3,000 community-dwelling whites and African Americans over the age of 50 years in the greater Boston area, said Dr. Durant of Beth Israel Deaconess Medical Center, Boston. Participants answered seven previously validated questions from a distrust index that measured attitudes about clinical research.

Societal distrust was defined as negative historical and cultural perceptions of physicians and clinical research in general. Interpersonal distrust was defined as negative perceptions of research based on one's relationship with an individual physician. Overall, distrust was defined as five or more distrustful responses to the seven questions.

Individuals' trust in the primary care provider (PCP) was measured with the eight-item trust subscale from the Primary Care Assessment Survey. Responses were grouped into quartiles. Independent variables included race, gender, age, education level, type of insurance, knowledge of the Tuskegee Syphilis Experiment, and personal experiences with discrimination in health care. Bivariate and multivariate analyses examined the associations among these factors and responses to the distrust index.

The analyses included 498 whites and 329 African Americans. White participants were significantly older and better educated. African American participants were significantly more likely than whites to have experienced discrimination in health care (43% vs. 15%, respectively).

Interestingly, a large percentage of both whites (59%) and African Americans (49%) had participated previously in a clinical trial. African Americans were more likely than whites to believe that health care providers might use them as “guinea pigs” without permission (54% vs. 28%) or to think that physicians prescribe medications to experiment on people without permission (58% vs. 41%). There was no significant difference between whites and African Americans in the percentage that believed that their physicians had ever treated them as part of an experiment without their giving permission (2.9% vs. 1.6%, respectively). Interpersonal distrust did not differ significantly between African Americans and whites.

In a multivariate model, African Americans and respondents with the least trust in their PCPs were more likely to think that they might be used as “guinea pigs” without permission (odds ratios, 2.7 and 2.8, respectively). African American race and being in the lowest quartile of trust in one's PCP were also associated with having concerns about experimental use of prescription medications (odds ratios, 1.9 and 1.8, respectively).

Neither familiarity with the Tuskegee Syphilis Experiment nor experience with discrimination in health care was significantly related to concerns about unwanted experimentation in multivariate models.

Because this study population was well educated overall and a large percentage had previous clinical trial experience, the results may not be representative of other populations. There may also have been some selection bias, as more whites (65%) responded to the survey than did African Americans (44%). “This [distrust] is a real dilemma,” Dr. Durant said. “We may not ever be able to impact society.”

Societal distrust in clinical research among minorities may hamper future research in many therapeutic areas.

LOS ANGELES — Older African Americans distrust clinical research significantly more than do older whites, according to results of a mail survey presented by Dr. Raegan W. Durant at the annual meeting of the Society of General Internal Medicine.

The study was designed to determine whether African Americans' distrust of clinical research arises from attitudes toward physicians and the health care system in general, or from their relationships with individual physicians.

The investigators conducted a mail survey of 3,000 community-dwelling whites and African Americans over the age of 50 years in the greater Boston area, said Dr. Durant of Beth Israel Deaconess Medical Center, Boston. Participants answered seven previously validated questions from a distrust index that measured attitudes about clinical research.

Societal distrust was defined as negative historical and cultural perceptions of physicians and clinical research in general. Interpersonal distrust was defined as negative perceptions of research based on one's relationship with an individual physician. Overall, distrust was defined as five or more distrustful responses to the seven questions.

Individuals' trust in the primary care provider (PCP) was measured with the eight-item trust subscale from the Primary Care Assessment Survey. Responses were grouped into quartiles. Independent variables included race, gender, age, education level, type of insurance, knowledge of the Tuskegee Syphilis Experiment, and personal experiences with discrimination in health care. Bivariate and multivariate analyses examined the associations among these factors and responses to the distrust index.

The analyses included 498 whites and 329 African Americans. White participants were significantly older and better educated. African American participants were significantly more likely than whites to have experienced discrimination in health care (43% vs. 15%, respectively).

Interestingly, a large percentage of both whites (59%) and African Americans (49%) had participated previously in a clinical trial. African Americans were more likely than whites to believe that health care providers might use them as “guinea pigs” without permission (54% vs. 28%) or to think that physicians prescribe medications to experiment on people without permission (58% vs. 41%). There was no significant difference between whites and African Americans in the percentage that believed that their physicians had ever treated them as part of an experiment without their giving permission (2.9% vs. 1.6%, respectively). Interpersonal distrust did not differ significantly between African Americans and whites.

In a multivariate model, African Americans and respondents with the least trust in their PCPs were more likely to think that they might be used as “guinea pigs” without permission (odds ratios, 2.7 and 2.8, respectively). African American race and being in the lowest quartile of trust in one's PCP were also associated with having concerns about experimental use of prescription medications (odds ratios, 1.9 and 1.8, respectively).

Neither familiarity with the Tuskegee Syphilis Experiment nor experience with discrimination in health care was significantly related to concerns about unwanted experimentation in multivariate models.

Because this study population was well educated overall and a large percentage had previous clinical trial experience, the results may not be representative of other populations. There may also have been some selection bias, as more whites (65%) responded to the survey than did African Americans (44%). “This [distrust] is a real dilemma,” Dr. Durant said. “We may not ever be able to impact society.”

Societal distrust in clinical research among minorities may hamper future research in many therapeutic areas.

LOS ANGELES — Older African Americans distrust clinical research significantly more than do older whites, according to results of a mail survey presented by Dr. Raegan W. Durant at the annual meeting of the Society of General Internal Medicine.

The study was designed to determine whether African Americans' distrust of clinical research arises from attitudes toward physicians and the health care system in general, or from their relationships with individual physicians.

The investigators conducted a mail survey of 3,000 community-dwelling whites and African Americans over the age of 50 years in the greater Boston area, said Dr. Durant of Beth Israel Deaconess Medical Center, Boston. Participants answered seven previously validated questions from a distrust index that measured attitudes about clinical research.

Societal distrust was defined as negative historical and cultural perceptions of physicians and clinical research in general. Interpersonal distrust was defined as negative perceptions of research based on one's relationship with an individual physician. Overall, distrust was defined as five or more distrustful responses to the seven questions.

Individuals' trust in the primary care provider (PCP) was measured with the eight-item trust subscale from the Primary Care Assessment Survey. Responses were grouped into quartiles. Independent variables included race, gender, age, education level, type of insurance, knowledge of the Tuskegee Syphilis Experiment, and personal experiences with discrimination in health care. Bivariate and multivariate analyses examined the associations among these factors and responses to the distrust index.

The analyses included 498 whites and 329 African Americans. White participants were significantly older and better educated. African American participants were significantly more likely than whites to have experienced discrimination in health care (43% vs. 15%, respectively).

Interestingly, a large percentage of both whites (59%) and African Americans (49%) had participated previously in a clinical trial. African Americans were more likely than whites to believe that health care providers might use them as “guinea pigs” without permission (54% vs. 28%) or to think that physicians prescribe medications to experiment on people without permission (58% vs. 41%). There was no significant difference between whites and African Americans in the percentage that believed that their physicians had ever treated them as part of an experiment without their giving permission (2.9% vs. 1.6%, respectively). Interpersonal distrust did not differ significantly between African Americans and whites.

In a multivariate model, African Americans and respondents with the least trust in their PCPs were more likely to think that they might be used as “guinea pigs” without permission (odds ratios, 2.7 and 2.8, respectively). African American race and being in the lowest quartile of trust in one's PCP were also associated with having concerns about experimental use of prescription medications (odds ratios, 1.9 and 1.8, respectively).

Neither familiarity with the Tuskegee Syphilis Experiment nor experience with discrimination in health care was significantly related to concerns about unwanted experimentation in multivariate models.

Because this study population was well educated overall and a large percentage had previous clinical trial experience, the results may not be representative of other populations. There may also have been some selection bias, as more whites (65%) responded to the survey than did African Americans (44%). “This [distrust] is a real dilemma,” Dr. Durant said. “We may not ever be able to impact society.”

Societal distrust in clinical research among minorities may hamper future research in many therapeutic areas.

LOS ANGELES — Women with type 2 diabetes may be treated for dyslipidemia less aggressively than men, and therefore may be at higher risk of developing cardiovascular disease, Dr. Quyen Ngo-Metzger reported at the annual meeting of the Society of General Internal Medicine.

Coronary heart disease (CHD) is a leading cause of death among women and among all patients with type 2 diabetes. Diabetes confers a four times greater risk of CHD in women, compared with a doubling of risk in men, said Dr. Ngo-Metzker, of the University of California, Irvine.

She and her associates examined quality of care in a sample of 4,879 men and 7,654 women with type 2 diabetes (mean age 56 years) who were treated at 16 Kaiser Permanente Georgia practices in 2002. About two-thirds of men and women received recommended hemoglobin A_1c and cholesterol testing. About one-quarter of men (25%) and women (27%) achieved glycemic control (a hemoglobin A_1c value of less than 7%).

Overall, 72% of men and 68% of women achieved LDL-cholesterol levels of less than 130 mg/dL, a statistically significantdifference. After adjustment for age and comorbid conditions in multivariate analyses, men were 26% more likely than women to have an LDL-cholesterol value of less than 130 mg/dL.

Among high-risk patients with known CHD, 86% of men and 76% of women had an LDL-cholesterol level of less than 130 mg/dL; after adjustment for age and comorbidity, men were twice as likely as women to have lipid control at this cutoff. In addition, 56% of men and 44% of women had an LDL-cholesterol level of less than 100 mg/dL; after adjustment, men were 64% more likely than women to have achieved control using this more stringent definition.

Forty-three percent of men were prescribed statins, versus 37% of women; this difference was statistically significant. Future research is needed, she noted, to determine whether the differences reflect providers' prescribing habits or personal preferences among women and men.

LOS ANGELES — Women with type 2 diabetes may be treated for dyslipidemia less aggressively than men, and therefore may be at higher risk of developing cardiovascular disease, Dr. Quyen Ngo-Metzger reported at the annual meeting of the Society of General Internal Medicine.

Coronary heart disease (CHD) is a leading cause of death among women and among all patients with type 2 diabetes. Diabetes confers a four times greater risk of CHD in women, compared with a doubling of risk in men, said Dr. Ngo-Metzker, of the University of California, Irvine.

She and her associates examined quality of care in a sample of 4,879 men and 7,654 women with type 2 diabetes (mean age 56 years) who were treated at 16 Kaiser Permanente Georgia practices in 2002. About two-thirds of men and women received recommended hemoglobin A_1c and cholesterol testing. About one-quarter of men (25%) and women (27%) achieved glycemic control (a hemoglobin A_1c value of less than 7%).

Overall, 72% of men and 68% of women achieved LDL-cholesterol levels of less than 130 mg/dL, a statistically significantdifference. After adjustment for age and comorbid conditions in multivariate analyses, men were 26% more likely than women to have an LDL-cholesterol value of less than 130 mg/dL.

Among high-risk patients with known CHD, 86% of men and 76% of women had an LDL-cholesterol level of less than 130 mg/dL; after adjustment for age and comorbidity, men were twice as likely as women to have lipid control at this cutoff. In addition, 56% of men and 44% of women had an LDL-cholesterol level of less than 100 mg/dL; after adjustment, men were 64% more likely than women to have achieved control using this more stringent definition.

Forty-three percent of men were prescribed statins, versus 37% of women; this difference was statistically significant. Future research is needed, she noted, to determine whether the differences reflect providers' prescribing habits or personal preferences among women and men.

LOS ANGELES — Women with type 2 diabetes may be treated for dyslipidemia less aggressively than men, and therefore may be at higher risk of developing cardiovascular disease, Dr. Quyen Ngo-Metzger reported at the annual meeting of the Society of General Internal Medicine.

Coronary heart disease (CHD) is a leading cause of death among women and among all patients with type 2 diabetes. Diabetes confers a four times greater risk of CHD in women, compared with a doubling of risk in men, said Dr. Ngo-Metzker, of the University of California, Irvine.

She and her associates examined quality of care in a sample of 4,879 men and 7,654 women with type 2 diabetes (mean age 56 years) who were treated at 16 Kaiser Permanente Georgia practices in 2002. About two-thirds of men and women received recommended hemoglobin A_1c and cholesterol testing. About one-quarter of men (25%) and women (27%) achieved glycemic control (a hemoglobin A_1c value of less than 7%).

Overall, 72% of men and 68% of women achieved LDL-cholesterol levels of less than 130 mg/dL, a statistically significantdifference. After adjustment for age and comorbid conditions in multivariate analyses, men were 26% more likely than women to have an LDL-cholesterol value of less than 130 mg/dL.

Among high-risk patients with known CHD, 86% of men and 76% of women had an LDL-cholesterol level of less than 130 mg/dL; after adjustment for age and comorbidity, men were twice as likely as women to have lipid control at this cutoff. In addition, 56% of men and 44% of women had an LDL-cholesterol level of less than 100 mg/dL; after adjustment, men were 64% more likely than women to have achieved control using this more stringent definition.

Forty-three percent of men were prescribed statins, versus 37% of women; this difference was statistically significant. Future research is needed, she noted, to determine whether the differences reflect providers' prescribing habits or personal preferences among women and men.

LOS ANGELES — Nearly one in nine patients admitted with an acute MI was seen shortly before the MI in the primary care setting with symptoms suggestive of acute cardiac ischemia, Dr. Thomas D. Sequist reported at the annual meeting of the Society of General Internal Medicine.

“We know from our own experience in Boston that missed diagnosis of MI in this setting is a rising source of malpractice claims,” said Dr. Sequist of Brigham and Women's Hospital.

The investigators identified 966 admissions for acute MI, of whom 106 (11%) had complained of symptoms typical of potential heart disease at their last outpatient visit. During the outpatient visit prior to the MI, chest pain and dyspnea accounted for more than three-quarters of all chief complaints. Other complaints included thoracic or epigastric pain, dizziness, weakness, or nausea.

This population-based case-control study used billing claims to identify admissions for acute MI from 2000 to 2004 among patients with no prior history of coronary heart disease (CHD). The 318 control patients were matched to cases on chief complaint and date of outpatient visit, but had no diagnosis of MI within the next 30 days.

Compared with controls, cases were older and were more likely to be male and to have diabetes or dyslipidemia. Approximately 50% of both cases and controls received an electrocardiogram (ECG). Not surprisingly, among those who had an ECG, the rates of normal results were much lower in cases than controls.

Despite having symptoms of possible CHD, few study participants in both groups received cardiac medications (aspirin, 11%; β-blockers, 7%). “There was a significant opportunity for more aggressive evaluation and treatment of these symptomatic patients,” Dr. Sequist said.

The Framingham Risk Score (FRS) predicts risk for developing CHD using information about coronary risk factors readily available in the outpatient setting, and may be used with asymptomatic individuals. In contrast, both the Diamond and Forrester Probability (DFP) and the Goldman Prediction Tool (GPT), which calculate risk scores that predict either CHD or MI, can only be used with individuals who have chest pain.

Cases had a nearly 20-fold greater likelihood of having a FRS greater than or equal to 10%, compared with controls (odds ratio, 19.5). Among patients whose FRS was greater than or equal to 10%, more than 30% were diagnosed with angina. Higher DFP and GPT scores were also associated with MI (odds ratio of 8.3 with a DFP score of 10% or more, and OR of 12.1 with a GPT greater than 7%). However, the FRS had the best sensitivity (85%) and specificity (75%) combination in those individuals at moderate risk.

LOS ANGELES — Nearly one in nine patients admitted with an acute MI was seen shortly before the MI in the primary care setting with symptoms suggestive of acute cardiac ischemia, Dr. Thomas D. Sequist reported at the annual meeting of the Society of General Internal Medicine.

“We know from our own experience in Boston that missed diagnosis of MI in this setting is a rising source of malpractice claims,” said Dr. Sequist of Brigham and Women's Hospital.

The investigators identified 966 admissions for acute MI, of whom 106 (11%) had complained of symptoms typical of potential heart disease at their last outpatient visit. During the outpatient visit prior to the MI, chest pain and dyspnea accounted for more than three-quarters of all chief complaints. Other complaints included thoracic or epigastric pain, dizziness, weakness, or nausea.

This population-based case-control study used billing claims to identify admissions for acute MI from 2000 to 2004 among patients with no prior history of coronary heart disease (CHD). The 318 control patients were matched to cases on chief complaint and date of outpatient visit, but had no diagnosis of MI within the next 30 days.

Compared with controls, cases were older and were more likely to be male and to have diabetes or dyslipidemia. Approximately 50% of both cases and controls received an electrocardiogram (ECG). Not surprisingly, among those who had an ECG, the rates of normal results were much lower in cases than controls.

Despite having symptoms of possible CHD, few study participants in both groups received cardiac medications (aspirin, 11%; β-blockers, 7%). “There was a significant opportunity for more aggressive evaluation and treatment of these symptomatic patients,” Dr. Sequist said.

The Framingham Risk Score (FRS) predicts risk for developing CHD using information about coronary risk factors readily available in the outpatient setting, and may be used with asymptomatic individuals. In contrast, both the Diamond and Forrester Probability (DFP) and the Goldman Prediction Tool (GPT), which calculate risk scores that predict either CHD or MI, can only be used with individuals who have chest pain.

Cases had a nearly 20-fold greater likelihood of having a FRS greater than or equal to 10%, compared with controls (odds ratio, 19.5). Among patients whose FRS was greater than or equal to 10%, more than 30% were diagnosed with angina. Higher DFP and GPT scores were also associated with MI (odds ratio of 8.3 with a DFP score of 10% or more, and OR of 12.1 with a GPT greater than 7%). However, the FRS had the best sensitivity (85%) and specificity (75%) combination in those individuals at moderate risk.

LOS ANGELES — Nearly one in nine patients admitted with an acute MI was seen shortly before the MI in the primary care setting with symptoms suggestive of acute cardiac ischemia, Dr. Thomas D. Sequist reported at the annual meeting of the Society of General Internal Medicine.

“We know from our own experience in Boston that missed diagnosis of MI in this setting is a rising source of malpractice claims,” said Dr. Sequist of Brigham and Women's Hospital.

The investigators identified 966 admissions for acute MI, of whom 106 (11%) had complained of symptoms typical of potential heart disease at their last outpatient visit. During the outpatient visit prior to the MI, chest pain and dyspnea accounted for more than three-quarters of all chief complaints. Other complaints included thoracic or epigastric pain, dizziness, weakness, or nausea.

This population-based case-control study used billing claims to identify admissions for acute MI from 2000 to 2004 among patients with no prior history of coronary heart disease (CHD). The 318 control patients were matched to cases on chief complaint and date of outpatient visit, but had no diagnosis of MI within the next 30 days.

Compared with controls, cases were older and were more likely to be male and to have diabetes or dyslipidemia. Approximately 50% of both cases and controls received an electrocardiogram (ECG). Not surprisingly, among those who had an ECG, the rates of normal results were much lower in cases than controls.

Despite having symptoms of possible CHD, few study participants in both groups received cardiac medications (aspirin, 11%; β-blockers, 7%). “There was a significant opportunity for more aggressive evaluation and treatment of these symptomatic patients,” Dr. Sequist said.

The Framingham Risk Score (FRS) predicts risk for developing CHD using information about coronary risk factors readily available in the outpatient setting, and may be used with asymptomatic individuals. In contrast, both the Diamond and Forrester Probability (DFP) and the Goldman Prediction Tool (GPT), which calculate risk scores that predict either CHD or MI, can only be used with individuals who have chest pain.

Cases had a nearly 20-fold greater likelihood of having a FRS greater than or equal to 10%, compared with controls (odds ratio, 19.5). Among patients whose FRS was greater than or equal to 10%, more than 30% were diagnosed with angina. Higher DFP and GPT scores were also associated with MI (odds ratio of 8.3 with a DFP score of 10% or more, and OR of 12.1 with a GPT greater than 7%). However, the FRS had the best sensitivity (85%) and specificity (75%) combination in those individuals at moderate risk.

LOS ANGELES — An attenuated herpes zoster virus vaccine effectively prevents herpes zoster and postherpetic neuralgia, according to a presentation by Dr. Samuel Cykert at the annual meeting of the Society of General Internal Medicine.

The vaccine (Zostavax, Merck & Co.), which was licensed for use in people age 60 years and older by the Food and Drug Administration in late May, is administered as a single injection. The lifetime risk of symptomatic shingles is estimated at 2 in every 10 people, the FDA noted in a statement announcing the licensure of the vaccine.

The vaccine's cost-effectiveness is dependent on the price of the vaccine and the age of the patients being vaccinated, said Dr. Cykert of the University of North Carolina at Chapel Hill.

The incidence of shingles nearly triples between the ages of 60 and 75 years, he added.

Prednisone and the prescription antivirals that are currently used to shorten symptom duration are not effective in preventing postherpetic neuralgia (PHN), Dr. Cykert said.

In the Shingles Prevention Study, more than 38,000 adults (median age, 69 years) were randomized to receive the live attenuated varicella-zoster virus vaccine, or placebo. The subjects were followed for an average of 3 years to determine whether they developed shingles, and if so, to assess the duration of the pain.

The vaccine reduced the occurrence of shingles by about 50% in participants aged 60 years and older, and by 64% in those aged 60–69 years. In those participants who received the vaccine but who still developed shingles, pain duration was reduced slightly, according to the FDA statement.

The most frequently reported side effects in subjects who received Zostavax were itching, headache, and redness, swelling, and pain at the injection site. Significant adverse events were not found to be more common among participants in the vaccine group, compared with those in the placebo group, the FDA noted.

The primary goals of Dr. Cykert's pharmacoeconomic study were to define the circumstances under which the vaccine would be considered cost effective, using the criterion of $50,000 per quality-adjusted life-year (QALY) gained.

The analysis estimated the cost-effectiveness of the vaccine by calculating the savings expected from prevention of herpes zoster (including reductions in treatment and in loss of work time for those younger than age 65) and subtracting that from the cost of the vaccine, Dr. Cykert expained.

“Our strategy of targeting 65-year-olds would create the best bang for the buck,” he said, because of the high incidence of shingles and the responsiveness to the vaccine at that age.

Among a cohort of 65-year-olds, the cost-effectiveness would be $57,840 per QALY. For all age groups combined, however, when the base model was run assuming lifetime vaccine efficacy, the cost per QALY would be $92,900. When the duration of vaccine efficacy was limited to 10 years, the base cost per QALY for all age groups would increase to $97,600, the analysis showed.

If the cost of the vaccine in the base model is reduced to $313 per unit, the cost meets the $50,000 per QALY cutoff. For the age-65 model, a vaccine price of $452 meets the same cutoff.

If the vaccine could be sold for $100 per dose, the vaccination strategy for 65-year-olds would actually save money, Dr. Cykert said.

According to Dr. Cykert, however, if the vaccine price remains high, other health care priorities would be likely to take precedence over a vaccine that does not actually save lives.

In contrast, if the vaccine is priced “responsibly,” he said, many older adults at risk of shingles are likely to benefit from an improved quality of life.

LOS ANGELES — An attenuated herpes zoster virus vaccine effectively prevents herpes zoster and postherpetic neuralgia, according to a presentation by Dr. Samuel Cykert at the annual meeting of the Society of General Internal Medicine.

The vaccine (Zostavax, Merck & Co.), which was licensed for use in people age 60 years and older by the Food and Drug Administration in late May, is administered as a single injection. The lifetime risk of symptomatic shingles is estimated at 2 in every 10 people, the FDA noted in a statement announcing the licensure of the vaccine.

The vaccine's cost-effectiveness is dependent on the price of the vaccine and the age of the patients being vaccinated, said Dr. Cykert of the University of North Carolina at Chapel Hill.

The incidence of shingles nearly triples between the ages of 60 and 75 years, he added.

Prednisone and the prescription antivirals that are currently used to shorten symptom duration are not effective in preventing postherpetic neuralgia (PHN), Dr. Cykert said.

In the Shingles Prevention Study, more than 38,000 adults (median age, 69 years) were randomized to receive the live attenuated varicella-zoster virus vaccine, or placebo. The subjects were followed for an average of 3 years to determine whether they developed shingles, and if so, to assess the duration of the pain.

The vaccine reduced the occurrence of shingles by about 50% in participants aged 60 years and older, and by 64% in those aged 60–69 years. In those participants who received the vaccine but who still developed shingles, pain duration was reduced slightly, according to the FDA statement.

The most frequently reported side effects in subjects who received Zostavax were itching, headache, and redness, swelling, and pain at the injection site. Significant adverse events were not found to be more common among participants in the vaccine group, compared with those in the placebo group, the FDA noted.

The primary goals of Dr. Cykert's pharmacoeconomic study were to define the circumstances under which the vaccine would be considered cost effective, using the criterion of $50,000 per quality-adjusted life-year (QALY) gained.

The analysis estimated the cost-effectiveness of the vaccine by calculating the savings expected from prevention of herpes zoster (including reductions in treatment and in loss of work time for those younger than age 65) and subtracting that from the cost of the vaccine, Dr. Cykert expained.

“Our strategy of targeting 65-year-olds would create the best bang for the buck,” he said, because of the high incidence of shingles and the responsiveness to the vaccine at that age.

Among a cohort of 65-year-olds, the cost-effectiveness would be $57,840 per QALY. For all age groups combined, however, when the base model was run assuming lifetime vaccine efficacy, the cost per QALY would be $92,900. When the duration of vaccine efficacy was limited to 10 years, the base cost per QALY for all age groups would increase to $97,600, the analysis showed.

If the cost of the vaccine in the base model is reduced to $313 per unit, the cost meets the $50,000 per QALY cutoff. For the age-65 model, a vaccine price of $452 meets the same cutoff.

If the vaccine could be sold for $100 per dose, the vaccination strategy for 65-year-olds would actually save money, Dr. Cykert said.

According to Dr. Cykert, however, if the vaccine price remains high, other health care priorities would be likely to take precedence over a vaccine that does not actually save lives.

In contrast, if the vaccine is priced “responsibly,” he said, many older adults at risk of shingles are likely to benefit from an improved quality of life.

LOS ANGELES — An attenuated herpes zoster virus vaccine effectively prevents herpes zoster and postherpetic neuralgia, according to a presentation by Dr. Samuel Cykert at the annual meeting of the Society of General Internal Medicine.

The vaccine (Zostavax, Merck & Co.), which was licensed for use in people age 60 years and older by the Food and Drug Administration in late May, is administered as a single injection. The lifetime risk of symptomatic shingles is estimated at 2 in every 10 people, the FDA noted in a statement announcing the licensure of the vaccine.

The vaccine's cost-effectiveness is dependent on the price of the vaccine and the age of the patients being vaccinated, said Dr. Cykert of the University of North Carolina at Chapel Hill.

The incidence of shingles nearly triples between the ages of 60 and 75 years, he added.

Prednisone and the prescription antivirals that are currently used to shorten symptom duration are not effective in preventing postherpetic neuralgia (PHN), Dr. Cykert said.

In the Shingles Prevention Study, more than 38,000 adults (median age, 69 years) were randomized to receive the live attenuated varicella-zoster virus vaccine, or placebo. The subjects were followed for an average of 3 years to determine whether they developed shingles, and if so, to assess the duration of the pain.

The vaccine reduced the occurrence of shingles by about 50% in participants aged 60 years and older, and by 64% in those aged 60–69 years. In those participants who received the vaccine but who still developed shingles, pain duration was reduced slightly, according to the FDA statement.

The most frequently reported side effects in subjects who received Zostavax were itching, headache, and redness, swelling, and pain at the injection site. Significant adverse events were not found to be more common among participants in the vaccine group, compared with those in the placebo group, the FDA noted.

The primary goals of Dr. Cykert's pharmacoeconomic study were to define the circumstances under which the vaccine would be considered cost effective, using the criterion of $50,000 per quality-adjusted life-year (QALY) gained.

The analysis estimated the cost-effectiveness of the vaccine by calculating the savings expected from prevention of herpes zoster (including reductions in treatment and in loss of work time for those younger than age 65) and subtracting that from the cost of the vaccine, Dr. Cykert expained.

“Our strategy of targeting 65-year-olds would create the best bang for the buck,” he said, because of the high incidence of shingles and the responsiveness to the vaccine at that age.

Among a cohort of 65-year-olds, the cost-effectiveness would be $57,840 per QALY. For all age groups combined, however, when the base model was run assuming lifetime vaccine efficacy, the cost per QALY would be $92,900. When the duration of vaccine efficacy was limited to 10 years, the base cost per QALY for all age groups would increase to $97,600, the analysis showed.

If the cost of the vaccine in the base model is reduced to $313 per unit, the cost meets the $50,000 per QALY cutoff. For the age-65 model, a vaccine price of $452 meets the same cutoff.

If the vaccine could be sold for $100 per dose, the vaccination strategy for 65-year-olds would actually save money, Dr. Cykert said.

According to Dr. Cykert, however, if the vaccine price remains high, other health care priorities would be likely to take precedence over a vaccine that does not actually save lives.

In contrast, if the vaccine is priced “responsibly,” he said, many older adults at risk of shingles are likely to benefit from an improved quality of life.

LOS ANGELES — A prediction rule combining five easily obtainable risk factors distinguishes with high sensitivity women at high risk of developing osteoporotic fractures within the next 3 years, Dr. Idris Guessous reported at the annual meeting of the Society of General Internal Medicine.

The Swiss Evaluation of the Methods of Measurement of Osteoporotic Fracture Risk (SEMOF) study was a 3-year, prospective, multicenter study (n = 623) that computed a prediction score using low heel ultrasound stiffness index (SI), older age, fracture history, recent fall, and missed chair test to predict subsequent development of osteoporotic hip fractures and other nonvertebral fractures.

The objective of the study was to compute a prediction rule to identify women at high risk of osteoporotic fracture in general, or a hip fracture in particular, within the next 3 years, said Dr. Guessous of the University Hospital of Lausanne, Switzerland.

The heel bone ultrasonometer (Lunar Corp., Madison, Wisc.) was chosen because it is simple, inexpensive, noninvasive, and transportable. Of 7,114 Swiss women who responded to a mailed request to participate, 6,174 women between 70 and 85 years old were enrolled. Exclusion criteria included previous hip fracture, bilateral hip replacement, renal failure, active cancer, and dementia. The investigators calculated the bone SI using quantitative ultrasound of the heel, broadband ultrasound attenuation, and the speed of sound as the input parameters. The SI is expressed as a percentage of the values obtained by the manufacturer in a young adult population. Osteoporotic fractures were defined as hip, wrist, or arm breaks that occurred spontaneously or secondary to falling from standing height or lower despite a low level of trauma.

The investigators included baseline characteristics (age, weight, height, body mass index), known risk factors for osteoporosis (fracture history, history of maternal hip fracture, current smoking habits, early menopause, surgical menopause), fall (history of recent fall, missed chair test), and SI as parameters to develop a score that would predict risk of osteoporotic fracture. The investigators then used bootstrap methods to evaluate the stability of the score, Dr. Guessous said.

Mean follow-up was 2.8 years (17,546 person-years). Five risk factors were independent, significant predictors of the incidence of osteoporotic fractures: age older than 75, SI greater than 78%, history of any prior fracture, history of a fall during the last 12 months, and missed chair test (not being able to rise from a chair three successive times without using one's arms).

The investigators assigned a score to each of the five significant predictors: age, up to 3; SI, up to 7.5; history of fall within past 12 months, 1.5; fracture history, 1; and positive chair test, 1. Thus, the maximum prediction score is 14 points. The cutoff score to discriminate women at high risk of fracture with 90% sensitivity is 4.5. With this cutoff, 1,464 women (23.7%) were considered at low risk of hip fracture (score less than 4.5), and 4,710 (76.3%) were considered at high risk (score at least 4.5).

Among these high risk women, 60 (1.3%) experienced an osteoporotic hip fracture. In contrast, 6 (0.4%) of the low-risk women experienced such a fracture.

The main limitation of this predictor rule is that at a sensitivity of 90%, the specificity was only 24%. Ideally, a predictor rule should have high specificity as well. In addition, women aged older than 85 years were not included, but there are few data showing that very elderly women benefit from osteoporosis treatment, Dr. Guessous said.

LOS ANGELES — A prediction rule combining five easily obtainable risk factors distinguishes with high sensitivity women at high risk of developing osteoporotic fractures within the next 3 years, Dr. Idris Guessous reported at the annual meeting of the Society of General Internal Medicine.

The Swiss Evaluation of the Methods of Measurement of Osteoporotic Fracture Risk (SEMOF) study was a 3-year, prospective, multicenter study (n = 623) that computed a prediction score using low heel ultrasound stiffness index (SI), older age, fracture history, recent fall, and missed chair test to predict subsequent development of osteoporotic hip fractures and other nonvertebral fractures.

The objective of the study was to compute a prediction rule to identify women at high risk of osteoporotic fracture in general, or a hip fracture in particular, within the next 3 years, said Dr. Guessous of the University Hospital of Lausanne, Switzerland.

The heel bone ultrasonometer (Lunar Corp., Madison, Wisc.) was chosen because it is simple, inexpensive, noninvasive, and transportable. Of 7,114 Swiss women who responded to a mailed request to participate, 6,174 women between 70 and 85 years old were enrolled. Exclusion criteria included previous hip fracture, bilateral hip replacement, renal failure, active cancer, and dementia. The investigators calculated the bone SI using quantitative ultrasound of the heel, broadband ultrasound attenuation, and the speed of sound as the input parameters. The SI is expressed as a percentage of the values obtained by the manufacturer in a young adult population. Osteoporotic fractures were defined as hip, wrist, or arm breaks that occurred spontaneously or secondary to falling from standing height or lower despite a low level of trauma.

The investigators included baseline characteristics (age, weight, height, body mass index), known risk factors for osteoporosis (fracture history, history of maternal hip fracture, current smoking habits, early menopause, surgical menopause), fall (history of recent fall, missed chair test), and SI as parameters to develop a score that would predict risk of osteoporotic fracture. The investigators then used bootstrap methods to evaluate the stability of the score, Dr. Guessous said.

Mean follow-up was 2.8 years (17,546 person-years). Five risk factors were independent, significant predictors of the incidence of osteoporotic fractures: age older than 75, SI greater than 78%, history of any prior fracture, history of a fall during the last 12 months, and missed chair test (not being able to rise from a chair three successive times without using one's arms).

The investigators assigned a score to each of the five significant predictors: age, up to 3; SI, up to 7.5; history of fall within past 12 months, 1.5; fracture history, 1; and positive chair test, 1. Thus, the maximum prediction score is 14 points. The cutoff score to discriminate women at high risk of fracture with 90% sensitivity is 4.5. With this cutoff, 1,464 women (23.7%) were considered at low risk of hip fracture (score less than 4.5), and 4,710 (76.3%) were considered at high risk (score at least 4.5).

Among these high risk women, 60 (1.3%) experienced an osteoporotic hip fracture. In contrast, 6 (0.4%) of the low-risk women experienced such a fracture.

The main limitation of this predictor rule is that at a sensitivity of 90%, the specificity was only 24%. Ideally, a predictor rule should have high specificity as well. In addition, women aged older than 85 years were not included, but there are few data showing that very elderly women benefit from osteoporosis treatment, Dr. Guessous said.

LOS ANGELES — A prediction rule combining five easily obtainable risk factors distinguishes with high sensitivity women at high risk of developing osteoporotic fractures within the next 3 years, Dr. Idris Guessous reported at the annual meeting of the Society of General Internal Medicine.

The Swiss Evaluation of the Methods of Measurement of Osteoporotic Fracture Risk (SEMOF) study was a 3-year, prospective, multicenter study (n = 623) that computed a prediction score using low heel ultrasound stiffness index (SI), older age, fracture history, recent fall, and missed chair test to predict subsequent development of osteoporotic hip fractures and other nonvertebral fractures.

The objective of the study was to compute a prediction rule to identify women at high risk of osteoporotic fracture in general, or a hip fracture in particular, within the next 3 years, said Dr. Guessous of the University Hospital of Lausanne, Switzerland.

The heel bone ultrasonometer (Lunar Corp., Madison, Wisc.) was chosen because it is simple, inexpensive, noninvasive, and transportable. Of 7,114 Swiss women who responded to a mailed request to participate, 6,174 women between 70 and 85 years old were enrolled. Exclusion criteria included previous hip fracture, bilateral hip replacement, renal failure, active cancer, and dementia. The investigators calculated the bone SI using quantitative ultrasound of the heel, broadband ultrasound attenuation, and the speed of sound as the input parameters. The SI is expressed as a percentage of the values obtained by the manufacturer in a young adult population. Osteoporotic fractures were defined as hip, wrist, or arm breaks that occurred spontaneously or secondary to falling from standing height or lower despite a low level of trauma.

The investigators included baseline characteristics (age, weight, height, body mass index), known risk factors for osteoporosis (fracture history, history of maternal hip fracture, current smoking habits, early menopause, surgical menopause), fall (history of recent fall, missed chair test), and SI as parameters to develop a score that would predict risk of osteoporotic fracture. The investigators then used bootstrap methods to evaluate the stability of the score, Dr. Guessous said.

Mean follow-up was 2.8 years (17,546 person-years). Five risk factors were independent, significant predictors of the incidence of osteoporotic fractures: age older than 75, SI greater than 78%, history of any prior fracture, history of a fall during the last 12 months, and missed chair test (not being able to rise from a chair three successive times without using one's arms).

The investigators assigned a score to each of the five significant predictors: age, up to 3; SI, up to 7.5; history of fall within past 12 months, 1.5; fracture history, 1; and positive chair test, 1. Thus, the maximum prediction score is 14 points. The cutoff score to discriminate women at high risk of fracture with 90% sensitivity is 4.5. With this cutoff, 1,464 women (23.7%) were considered at low risk of hip fracture (score less than 4.5), and 4,710 (76.3%) were considered at high risk (score at least 4.5).

Among these high risk women, 60 (1.3%) experienced an osteoporotic hip fracture. In contrast, 6 (0.4%) of the low-risk women experienced such a fracture.

The main limitation of this predictor rule is that at a sensitivity of 90%, the specificity was only 24%. Ideally, a predictor rule should have high specificity as well. In addition, women aged older than 85 years were not included, but there are few data showing that very elderly women benefit from osteoporosis treatment, Dr. Guessous said.

LOS ANGELES — Physicians and patients are likely to reject bisphosphonate therapy when treatment efficacy is expressed in terms of absolute risk reduction, as health literacy experts recommend, rather than relative risk reduction, Dr. Christine A. Sinsky reported at the annual meeting of the Society of General Internal Medicine.

A patient's decision to reject lifelong treatment for osteoporosis may have a negative impact on a practice's income if pay for performance is linked to compliance with clinical practice guidelines.

Those guidelines recommend the use of bisphosphonates to treat postmenopausal osteoporosis. Clinicians may deviate from these guidelines; some payers, however, link provider reimbursement for osteoporosis care to guideline adherence.

Practice guidelines, clinical trial reports, and direct to consumer advertising that recommend drug treatment for osteoporosis tend to cite relative risk reduction (RRR) when describing the benefits of therapy. Experts in health literacy, however, prefer to describe treatment benefits as absolute risk reduction (ARR), because RRR tends to overestimate risks when there is a low baseline frequency of a condition, such as hip fracture in osteoporosis. Data from the U.S. Preventive Services Task Force (USPSTF) suggest that after 5 years of treatment with bisphosphonates, the RRR for hip fracture is 35%, whereas the absolute risk of fracture in the at-risk population decreases from 3% to 2%, yield a 1% ARR (Ann. Int. Med. 2002;137:526–8).

“First, you have to get the doctors to understand the difference between RRR and ARR,” stated Dr. Sinsky, an internist in private practice in Dubuque, Iowa. She illustrated these concepts for the physician audience with a 10 by 10 grid of 100 happy faces, with three (those destined for hip fracture regardless of treatment) colored red. If treatment prevents one hip fracture out of three (roughly what the USPSTF found), one red face turned blue. If the reference class includes only the three patients who would have gotten a fracture, regardless of treatment, then the RRR is 33.3%. If the reference class includes all 100 women at risk of fracture, the ARR is 1%.

The investigators hypothesized that both patient and provider willingness to try bisphosphonate therapy for osteoporosis would be significantly lower if the efficacy were presented as ARR rather than as RRR.

The investigators administered a 10-item questionnaire to 641 consecutive female patients (aged 50 years or older) and all general medicine physicians at one university-based practice and one community practice. To assess baseline compliance with clinical practice guidelines, physicians asked patients: “You have a bone density test that indicates osteoporosis. You have full drug coverage. Are you interested in treatment?” Providers were asked: “Your 65-year-old patient has a [dual-energy x-ray absorptiometry] scan that indicates osteoporosis. The patient has full drug coverage. Would you recommend treatment?” Other scenarios presented out-of-pocket costs to the patient ranging from 0% to 90%. Subsequent questions presented similar scenarios but with efficacy of treatment presented as either RRR or ARR.

When treatment benefit was presented as RRR, 86% of patients expressed interest, compared with 57% when benefit was expressed as ARR (P < .005). Similarly, physicians were significantly more likely to recommend osteoporosis treatment for their patients when treatment benefits were presented as RRR (97%) as opposed to ARR (53%) (P < .005).

Patients were told that the cost of bisphosphonate therapy is about &dollar;1,000 per year. When the scenario stated that insurance would cover the entire cost of treatment, 81% of patients wanted therapy. In contrast, if insurance would cover only 10% of the cost, 15% of patients wanted therapy (P = .04). Under scenarios in which patients had full coverage, 100% recommended therapy; in contrast, 61% recommended therapy when insurance covered only 10% (P = .02). The data support the investigators' original hypothesis.

The data suggest that better informed patients may choose to reject lifelong drug treatment for osteoporosis.

LOS ANGELES — Physicians and patients are likely to reject bisphosphonate therapy when treatment efficacy is expressed in terms of absolute risk reduction, as health literacy experts recommend, rather than relative risk reduction, Dr. Christine A. Sinsky reported at the annual meeting of the Society of General Internal Medicine.

A patient's decision to reject lifelong treatment for osteoporosis may have a negative impact on a practice's income if pay for performance is linked to compliance with clinical practice guidelines.

Those guidelines recommend the use of bisphosphonates to treat postmenopausal osteoporosis. Clinicians may deviate from these guidelines; some payers, however, link provider reimbursement for osteoporosis care to guideline adherence.

Practice guidelines, clinical trial reports, and direct to consumer advertising that recommend drug treatment for osteoporosis tend to cite relative risk reduction (RRR) when describing the benefits of therapy. Experts in health literacy, however, prefer to describe treatment benefits as absolute risk reduction (ARR), because RRR tends to overestimate risks when there is a low baseline frequency of a condition, such as hip fracture in osteoporosis. Data from the U.S. Preventive Services Task Force (USPSTF) suggest that after 5 years of treatment with bisphosphonates, the RRR for hip fracture is 35%, whereas the absolute risk of fracture in the at-risk population decreases from 3% to 2%, yield a 1% ARR (Ann. Int. Med. 2002;137:526–8).

“First, you have to get the doctors to understand the difference between RRR and ARR,” stated Dr. Sinsky, an internist in private practice in Dubuque, Iowa. She illustrated these concepts for the physician audience with a 10 by 10 grid of 100 happy faces, with three (those destined for hip fracture regardless of treatment) colored red. If treatment prevents one hip fracture out of three (roughly what the USPSTF found), one red face turned blue. If the reference class includes only the three patients who would have gotten a fracture, regardless of treatment, then the RRR is 33.3%. If the reference class includes all 100 women at risk of fracture, the ARR is 1%.

The investigators hypothesized that both patient and provider willingness to try bisphosphonate therapy for osteoporosis would be significantly lower if the efficacy were presented as ARR rather than as RRR.

The investigators administered a 10-item questionnaire to 641 consecutive female patients (aged 50 years or older) and all general medicine physicians at one university-based practice and one community practice. To assess baseline compliance with clinical practice guidelines, physicians asked patients: “You have a bone density test that indicates osteoporosis. You have full drug coverage. Are you interested in treatment?” Providers were asked: “Your 65-year-old patient has a [dual-energy x-ray absorptiometry] scan that indicates osteoporosis. The patient has full drug coverage. Would you recommend treatment?” Other scenarios presented out-of-pocket costs to the patient ranging from 0% to 90%. Subsequent questions presented similar scenarios but with efficacy of treatment presented as either RRR or ARR.

When treatment benefit was presented as RRR, 86% of patients expressed interest, compared with 57% when benefit was expressed as ARR (P < .005). Similarly, physicians were significantly more likely to recommend osteoporosis treatment for their patients when treatment benefits were presented as RRR (97%) as opposed to ARR (53%) (P < .005).

Patients were told that the cost of bisphosphonate therapy is about &dollar;1,000 per year. When the scenario stated that insurance would cover the entire cost of treatment, 81% of patients wanted therapy. In contrast, if insurance would cover only 10% of the cost, 15% of patients wanted therapy (P = .04). Under scenarios in which patients had full coverage, 100% recommended therapy; in contrast, 61% recommended therapy when insurance covered only 10% (P = .02). The data support the investigators' original hypothesis.

The data suggest that better informed patients may choose to reject lifelong drug treatment for osteoporosis.

LOS ANGELES — Physicians and patients are likely to reject bisphosphonate therapy when treatment efficacy is expressed in terms of absolute risk reduction, as health literacy experts recommend, rather than relative risk reduction, Dr. Christine A. Sinsky reported at the annual meeting of the Society of General Internal Medicine.

A patient's decision to reject lifelong treatment for osteoporosis may have a negative impact on a practice's income if pay for performance is linked to compliance with clinical practice guidelines.

Those guidelines recommend the use of bisphosphonates to treat postmenopausal osteoporosis. Clinicians may deviate from these guidelines; some payers, however, link provider reimbursement for osteoporosis care to guideline adherence.

Practice guidelines, clinical trial reports, and direct to consumer advertising that recommend drug treatment for osteoporosis tend to cite relative risk reduction (RRR) when describing the benefits of therapy. Experts in health literacy, however, prefer to describe treatment benefits as absolute risk reduction (ARR), because RRR tends to overestimate risks when there is a low baseline frequency of a condition, such as hip fracture in osteoporosis. Data from the U.S. Preventive Services Task Force (USPSTF) suggest that after 5 years of treatment with bisphosphonates, the RRR for hip fracture is 35%, whereas the absolute risk of fracture in the at-risk population decreases from 3% to 2%, yield a 1% ARR (Ann. Int. Med. 2002;137:526–8).

“First, you have to get the doctors to understand the difference between RRR and ARR,” stated Dr. Sinsky, an internist in private practice in Dubuque, Iowa. She illustrated these concepts for the physician audience with a 10 by 10 grid of 100 happy faces, with three (those destined for hip fracture regardless of treatment) colored red. If treatment prevents one hip fracture out of three (roughly what the USPSTF found), one red face turned blue. If the reference class includes only the three patients who would have gotten a fracture, regardless of treatment, then the RRR is 33.3%. If the reference class includes all 100 women at risk of fracture, the ARR is 1%.

The investigators hypothesized that both patient and provider willingness to try bisphosphonate therapy for osteoporosis would be significantly lower if the efficacy were presented as ARR rather than as RRR.

The investigators administered a 10-item questionnaire to 641 consecutive female patients (aged 50 years or older) and all general medicine physicians at one university-based practice and one community practice. To assess baseline compliance with clinical practice guidelines, physicians asked patients: “You have a bone density test that indicates osteoporosis. You have full drug coverage. Are you interested in treatment?” Providers were asked: “Your 65-year-old patient has a [dual-energy x-ray absorptiometry] scan that indicates osteoporosis. The patient has full drug coverage. Would you recommend treatment?” Other scenarios presented out-of-pocket costs to the patient ranging from 0% to 90%. Subsequent questions presented similar scenarios but with efficacy of treatment presented as either RRR or ARR.

When treatment benefit was presented as RRR, 86% of patients expressed interest, compared with 57% when benefit was expressed as ARR (P < .005). Similarly, physicians were significantly more likely to recommend osteoporosis treatment for their patients when treatment benefits were presented as RRR (97%) as opposed to ARR (53%) (P < .005).

Patients were told that the cost of bisphosphonate therapy is about &dollar;1,000 per year. When the scenario stated that insurance would cover the entire cost of treatment, 81% of patients wanted therapy. In contrast, if insurance would cover only 10% of the cost, 15% of patients wanted therapy (P = .04). Under scenarios in which patients had full coverage, 100% recommended therapy; in contrast, 61% recommended therapy when insurance covered only 10% (P = .02). The data support the investigators' original hypothesis.

The data suggest that better informed patients may choose to reject lifelong drug treatment for osteoporosis.