Mary Ann Moon

The investigational drug lasofoxifene decreases the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, according to a report.

The nonsteroidal selective estrogen-receptor modulator (SERM) also reduces the risk of ER-positive breast cancer, major coronary heart disease events, and stroke without raising the risk of endometrial cancer or hyperplasia.

Like other SERMs, lasofoxifene raises the risk of venous thromboembolism and increases the rate of hot flushes and leg cramps, wrote Dr. Steven R. Cummings of California Pacific Medical Center Research Institute, San Francisco, and his associates in the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) study.

Taken together, these findings seem to indicate that lasofoxifene performs somewhat better than do other SERMs such as raloxifene, and also has advantages over hormone therapy, tamoxifen, and tibolone.

However, in an editorial accompanying this report, Dr. Carolyn Becker of the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital, Boston, argued that the drug “offers no major clinically important benefits over raloxifene for the skeleton, breast, heart, or reproductive tract.

“Given the plethora of drugs currently available for osteoporosis, studies of new agents should show clear benefits over existing agents,” she wrote. Results of the PEARL study do not do so, Dr. Becker added.

Dr. Cummings and his colleagues performed the international, randomized, placebo-controlled PEARL study in 8,556 women aged 59-80 years who had a bone mineral density T score of −2.5 or less at the lumbar spine or femoral neck. A total of 28% already had at least one vertebral fracture at baseline.

After 5 years of follow-up, women who received 0.5 mg per day of lasofoxifene showed a 42% reduction in relative risk for vertebral fractures and a 24% reduction in relative risk for nonvertebral fractures, compared with those who received placebo.

Bone density at the lumbar spine, femoral neck, and total hip improved by about 3% with the active drug, the investigators said (N. Engl. J. Med. 2010;362:686-96).

This decrease in risk of vertebral fractures is comparable with that reported in women taking raloxifene, estrogen therapy, oral bisphosphonates, and tibolone.

The decrease in risk of nonvertebral fractures also is similar to that observed in women taking other antiresorptive therapies, and it stands in contrast to raloxifene's inability to reduce this risk, they said.

However, Dr. Becker noted in her editorial that nearly all the reduction in risk for nonvertebral fractures could be attributed to forearm and wrist fractures. “A significant effect in the overall group was not evident until 5 years, and absolute risk reductions were very small.

“On balance, lasofoxifene seems to offer little, if any, advantage over raloxifene as an agent against osteoporosis,” she said (N. Engl. J. Med. 2010;362:752-4).

Lasofoxifene also reduced the risk of ER-positive breast cancer by 85%, compared with placebo. Although this finding is “impressive,” it is similar to the risk reduction reported for raloxifene, Dr. Becker added.

Lasofoxifene was associated with a 32% reduction in relative risk of coronary heart disease events (5.1 cases per 1,000 person-years) and a 36% reduction in relative risk of stroke (2.5 cases per 1,000 person-years), compared with placebo (7.5 and 3.9 cases per 1,000 person-years, respectively), Dr. Cummings and his associates said.

However, Dr. Becker noted that the number of these events was quite small, and there were no differences in rates of fatal stroke. “Although the cardiovascular benefits reported in the PEARL trial seem impressive, one would need to treat 492 patients for 1 year to prevent a single major coronary event,” she said.

The PEARL investigators said that lasofoxifene raised the risk of venous thromboembolism to a similar degree as do raloxifene, tamoxifen, and oral estrogen therapies. Like these agents, lasofoxifene also significantly increased the rate of hot flushes and leg cramps. It did not raise the risk of endometrial cancer or endometrial hyperplasia.

Dr. Becker countered that although the increase in absolute risk of venous thromboembolism was small, lasofoxifene more than doubled the relative risk.

In addition, rates of uterine polyps, endometrial hypertrophy, and vaginal candidiasis all were significantly higher than with placebo, she said.

Pfizer submitted a new drug application to the Food and Drug Administration in 2007, and in 2008 an advisory panel voted 9-3 that the benefits of the SERM outweighed this risk in postmenopausal women with osteoporosis. The FDA has not yet issued a decision.

Disclosures: The PEARL study was funded by Pfizer, manufacturer of lasofoxifene. Dr. Cummings reported receiving consulting fees from Amgen, Eli Lilly, GlaxoSmithKline, and Organon, lecture fees from Eli Lilly and Novartis, and grant support from Amgen, Pfizer, and Eli Lilly. Dr. Becker's financial disclosures are available with the text of the article at NEJM.org

The investigational drug lasofoxifene decreases the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, according to a report.

The nonsteroidal selective estrogen-receptor modulator (SERM) also reduces the risk of ER-positive breast cancer, major coronary heart disease events, and stroke without raising the risk of endometrial cancer or hyperplasia.

Like other SERMs, lasofoxifene raises the risk of venous thromboembolism and increases the rate of hot flushes and leg cramps, wrote Dr. Steven R. Cummings of California Pacific Medical Center Research Institute, San Francisco, and his associates in the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) study.

Taken together, these findings seem to indicate that lasofoxifene performs somewhat better than do other SERMs such as raloxifene, and also has advantages over hormone therapy, tamoxifen, and tibolone.

However, in an editorial accompanying this report, Dr. Carolyn Becker of the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital, Boston, argued that the drug “offers no major clinically important benefits over raloxifene for the skeleton, breast, heart, or reproductive tract.

“Given the plethora of drugs currently available for osteoporosis, studies of new agents should show clear benefits over existing agents,” she wrote. Results of the PEARL study do not do so, Dr. Becker added.

Dr. Cummings and his colleagues performed the international, randomized, placebo-controlled PEARL study in 8,556 women aged 59-80 years who had a bone mineral density T score of −2.5 or less at the lumbar spine or femoral neck. A total of 28% already had at least one vertebral fracture at baseline.

After 5 years of follow-up, women who received 0.5 mg per day of lasofoxifene showed a 42% reduction in relative risk for vertebral fractures and a 24% reduction in relative risk for nonvertebral fractures, compared with those who received placebo.

Bone density at the lumbar spine, femoral neck, and total hip improved by about 3% with the active drug, the investigators said (N. Engl. J. Med. 2010;362:686-96).

This decrease in risk of vertebral fractures is comparable with that reported in women taking raloxifene, estrogen therapy, oral bisphosphonates, and tibolone.

The decrease in risk of nonvertebral fractures also is similar to that observed in women taking other antiresorptive therapies, and it stands in contrast to raloxifene's inability to reduce this risk, they said.

However, Dr. Becker noted in her editorial that nearly all the reduction in risk for nonvertebral fractures could be attributed to forearm and wrist fractures. “A significant effect in the overall group was not evident until 5 years, and absolute risk reductions were very small.

“On balance, lasofoxifene seems to offer little, if any, advantage over raloxifene as an agent against osteoporosis,” she said (N. Engl. J. Med. 2010;362:752-4).

Lasofoxifene also reduced the risk of ER-positive breast cancer by 85%, compared with placebo. Although this finding is “impressive,” it is similar to the risk reduction reported for raloxifene, Dr. Becker added.

Lasofoxifene was associated with a 32% reduction in relative risk of coronary heart disease events (5.1 cases per 1,000 person-years) and a 36% reduction in relative risk of stroke (2.5 cases per 1,000 person-years), compared with placebo (7.5 and 3.9 cases per 1,000 person-years, respectively), Dr. Cummings and his associates said.

However, Dr. Becker noted that the number of these events was quite small, and there were no differences in rates of fatal stroke. “Although the cardiovascular benefits reported in the PEARL trial seem impressive, one would need to treat 492 patients for 1 year to prevent a single major coronary event,” she said.

The PEARL investigators said that lasofoxifene raised the risk of venous thromboembolism to a similar degree as do raloxifene, tamoxifen, and oral estrogen therapies. Like these agents, lasofoxifene also significantly increased the rate of hot flushes and leg cramps. It did not raise the risk of endometrial cancer or endometrial hyperplasia.

Dr. Becker countered that although the increase in absolute risk of venous thromboembolism was small, lasofoxifene more than doubled the relative risk.

In addition, rates of uterine polyps, endometrial hypertrophy, and vaginal candidiasis all were significantly higher than with placebo, she said.

Pfizer submitted a new drug application to the Food and Drug Administration in 2007, and in 2008 an advisory panel voted 9-3 that the benefits of the SERM outweighed this risk in postmenopausal women with osteoporosis. The FDA has not yet issued a decision.

Disclosures: The PEARL study was funded by Pfizer, manufacturer of lasofoxifene. Dr. Cummings reported receiving consulting fees from Amgen, Eli Lilly, GlaxoSmithKline, and Organon, lecture fees from Eli Lilly and Novartis, and grant support from Amgen, Pfizer, and Eli Lilly. Dr. Becker's financial disclosures are available with the text of the article at NEJM.org

The investigational drug lasofoxifene decreases the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, according to a report.

The nonsteroidal selective estrogen-receptor modulator (SERM) also reduces the risk of ER-positive breast cancer, major coronary heart disease events, and stroke without raising the risk of endometrial cancer or hyperplasia.

Like other SERMs, lasofoxifene raises the risk of venous thromboembolism and increases the rate of hot flushes and leg cramps, wrote Dr. Steven R. Cummings of California Pacific Medical Center Research Institute, San Francisco, and his associates in the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) study.

Taken together, these findings seem to indicate that lasofoxifene performs somewhat better than do other SERMs such as raloxifene, and also has advantages over hormone therapy, tamoxifen, and tibolone.

However, in an editorial accompanying this report, Dr. Carolyn Becker of the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital, Boston, argued that the drug “offers no major clinically important benefits over raloxifene for the skeleton, breast, heart, or reproductive tract.

“Given the plethora of drugs currently available for osteoporosis, studies of new agents should show clear benefits over existing agents,” she wrote. Results of the PEARL study do not do so, Dr. Becker added.

Dr. Cummings and his colleagues performed the international, randomized, placebo-controlled PEARL study in 8,556 women aged 59-80 years who had a bone mineral density T score of −2.5 or less at the lumbar spine or femoral neck. A total of 28% already had at least one vertebral fracture at baseline.

After 5 years of follow-up, women who received 0.5 mg per day of lasofoxifene showed a 42% reduction in relative risk for vertebral fractures and a 24% reduction in relative risk for nonvertebral fractures, compared with those who received placebo.

Bone density at the lumbar spine, femoral neck, and total hip improved by about 3% with the active drug, the investigators said (N. Engl. J. Med. 2010;362:686-96).

This decrease in risk of vertebral fractures is comparable with that reported in women taking raloxifene, estrogen therapy, oral bisphosphonates, and tibolone.

The decrease in risk of nonvertebral fractures also is similar to that observed in women taking other antiresorptive therapies, and it stands in contrast to raloxifene's inability to reduce this risk, they said.

However, Dr. Becker noted in her editorial that nearly all the reduction in risk for nonvertebral fractures could be attributed to forearm and wrist fractures. “A significant effect in the overall group was not evident until 5 years, and absolute risk reductions were very small.

“On balance, lasofoxifene seems to offer little, if any, advantage over raloxifene as an agent against osteoporosis,” she said (N. Engl. J. Med. 2010;362:752-4).

Lasofoxifene also reduced the risk of ER-positive breast cancer by 85%, compared with placebo. Although this finding is “impressive,” it is similar to the risk reduction reported for raloxifene, Dr. Becker added.

Lasofoxifene was associated with a 32% reduction in relative risk of coronary heart disease events (5.1 cases per 1,000 person-years) and a 36% reduction in relative risk of stroke (2.5 cases per 1,000 person-years), compared with placebo (7.5 and 3.9 cases per 1,000 person-years, respectively), Dr. Cummings and his associates said.

However, Dr. Becker noted that the number of these events was quite small, and there were no differences in rates of fatal stroke. “Although the cardiovascular benefits reported in the PEARL trial seem impressive, one would need to treat 492 patients for 1 year to prevent a single major coronary event,” she said.

The PEARL investigators said that lasofoxifene raised the risk of venous thromboembolism to a similar degree as do raloxifene, tamoxifen, and oral estrogen therapies. Like these agents, lasofoxifene also significantly increased the rate of hot flushes and leg cramps. It did not raise the risk of endometrial cancer or endometrial hyperplasia.

Dr. Becker countered that although the increase in absolute risk of venous thromboembolism was small, lasofoxifene more than doubled the relative risk.

In addition, rates of uterine polyps, endometrial hypertrophy, and vaginal candidiasis all were significantly higher than with placebo, she said.

Pfizer submitted a new drug application to the Food and Drug Administration in 2007, and in 2008 an advisory panel voted 9-3 that the benefits of the SERM outweighed this risk in postmenopausal women with osteoporosis. The FDA has not yet issued a decision.

Disclosures: The PEARL study was funded by Pfizer, manufacturer of lasofoxifene. Dr. Cummings reported receiving consulting fees from Amgen, Eli Lilly, GlaxoSmithKline, and Organon, lecture fees from Eli Lilly and Novartis, and grant support from Amgen, Pfizer, and Eli Lilly. Dr. Becker's financial disclosures are available with the text of the article at NEJM.org

A review of the recent literature confirms that comparative effectiveness research—studies designed to help physicians use existing treatments and treatment strategies more effectively—is severely lacking.

Fewer than a third of the studies published in the six top journals covering general and internal medicine qualified as comparative effectiveness research.

This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Mass.) Health Alliance and Harvard Medical School, Boston.

Congress recently passed legislation to provide more than $1 billion to support comparative effectiveness studies, and President Obama's budget for 2011 recommends further funding of comparative effectiveness research.

Noting that few data are available on the current status of comparative effectiveness research, Dr. Hochman and Dr. McCormick reviewed all clinical studies assessing medications that were published between June 2008 and October 2009 in the six “highest impact” medical journals: New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine.

These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951–8).

Of the 328 randomized trials, observational studies, or meta-analyses involving medications included in the analysis, 104 (32%) were comparative effectiveness studies.

Of those, just 11% compared medications with nonpharmacologic treatments, confirming that there is a relative lack of such research.

Comparative effectiveness studies that compare medications with nonpharmacologic interventions are particularly important because they help clinicians “make fundamental therapeutic decisions,” Dr. Hochman and Dr. McCormick said.

Nearly 90% of the comparative effectiveness studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is.

“Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results.

In addition, 24% of the randomized trials that did use an active comparator sought to show only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Patient safety was the focus of 19% of the comparative effectiveness studies, implying that safety concerns are not adequately measured in medication studies.

Only 2% of the comparative effectiveness studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care. This absence “may reflect policies or editorial priorities of journal editors favoring publication of clinical outcome reports rather than a true dearth of cost-effectiveness studies,” the investigators said.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for comparative effectiveness studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

The investigators reported no financial conflicts of interest.

A review of the recent literature confirms that comparative effectiveness research—studies designed to help physicians use existing treatments and treatment strategies more effectively—is severely lacking.

Fewer than a third of the studies published in the six top journals covering general and internal medicine qualified as comparative effectiveness research.

This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Mass.) Health Alliance and Harvard Medical School, Boston.

Congress recently passed legislation to provide more than $1 billion to support comparative effectiveness studies, and President Obama's budget for 2011 recommends further funding of comparative effectiveness research.

Noting that few data are available on the current status of comparative effectiveness research, Dr. Hochman and Dr. McCormick reviewed all clinical studies assessing medications that were published between June 2008 and October 2009 in the six “highest impact” medical journals: New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine.

These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951–8).

Of the 328 randomized trials, observational studies, or meta-analyses involving medications included in the analysis, 104 (32%) were comparative effectiveness studies.

Of those, just 11% compared medications with nonpharmacologic treatments, confirming that there is a relative lack of such research.

Comparative effectiveness studies that compare medications with nonpharmacologic interventions are particularly important because they help clinicians “make fundamental therapeutic decisions,” Dr. Hochman and Dr. McCormick said.

Nearly 90% of the comparative effectiveness studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is.

“Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results.

In addition, 24% of the randomized trials that did use an active comparator sought to show only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Patient safety was the focus of 19% of the comparative effectiveness studies, implying that safety concerns are not adequately measured in medication studies.

Only 2% of the comparative effectiveness studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care. This absence “may reflect policies or editorial priorities of journal editors favoring publication of clinical outcome reports rather than a true dearth of cost-effectiveness studies,” the investigators said.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for comparative effectiveness studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

The investigators reported no financial conflicts of interest.

A review of the recent literature confirms that comparative effectiveness research—studies designed to help physicians use existing treatments and treatment strategies more effectively—is severely lacking.

Fewer than a third of the studies published in the six top journals covering general and internal medicine qualified as comparative effectiveness research.

This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Mass.) Health Alliance and Harvard Medical School, Boston.

Congress recently passed legislation to provide more than $1 billion to support comparative effectiveness studies, and President Obama's budget for 2011 recommends further funding of comparative effectiveness research.

Noting that few data are available on the current status of comparative effectiveness research, Dr. Hochman and Dr. McCormick reviewed all clinical studies assessing medications that were published between June 2008 and October 2009 in the six “highest impact” medical journals: New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine.

These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951–8).

Of the 328 randomized trials, observational studies, or meta-analyses involving medications included in the analysis, 104 (32%) were comparative effectiveness studies.

Of those, just 11% compared medications with nonpharmacologic treatments, confirming that there is a relative lack of such research.

Comparative effectiveness studies that compare medications with nonpharmacologic interventions are particularly important because they help clinicians “make fundamental therapeutic decisions,” Dr. Hochman and Dr. McCormick said.

Nearly 90% of the comparative effectiveness studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is.

“Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results.

In addition, 24% of the randomized trials that did use an active comparator sought to show only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Patient safety was the focus of 19% of the comparative effectiveness studies, implying that safety concerns are not adequately measured in medication studies.

Only 2% of the comparative effectiveness studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care. This absence “may reflect policies or editorial priorities of journal editors favoring publication of clinical outcome reports rather than a true dearth of cost-effectiveness studies,” the investigators said.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for comparative effectiveness studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

The investigators reported no financial conflicts of interest.

Current methods for profiling physicians as to whether they provide low- or high-cost care are often inaccurate and produce misleading results, according to a report in the New England Journal of Medicine.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to the physicians whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proved, according to John L. Adams, Ph.D., of Rand Corp., Santa Monica, Calif., and his associates.

“To our knowledge, the reliability of physician cost profiling has not been previously addressed,” they noted.

Dr. Adams and his colleagues assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. The 12,789 physicians included in the study were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years.

The physicians worked in 28 specialties, including endocrinology, cardiology, gastroenterology, and obstetrics and gynecology. Family physicians, general physicians, and internal medicine physicians comprised approximately one-third of the sample.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Overall, 41% of physicians across all specialties had cost profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy. Only 22% of endocrinologists, 47% of internists, 30% of cardiologists, 41% of family or general physicians, 57% of ob.gyns., and 59% of gastroenterologists received scores of 0.70.

Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not lower cost ranged from 29% to 67%, depending on the specialty. Fully 50% of endocrinologists, 50% of internists, 40% of cardiologists, 39% of family or general physicians, 36% of ob.gyns., and 32% of gastroenterologists were misclassified as “lower-cost” providers when they were not.

In addition, 19% of endocrinologists, 22% of internists, 14% of cardiologists, 16% of family or general physicians, 10% of ob.gyns., and 11% of gastroenterologists were misclassified as “higher cost” when they were not in fact higher cost.

These findings indicate that standard methods of cost profiling are highly unreliable, and that many individuals and groups are basing important decisions on inaccuracies. “Consumers, physicians, and purchasers are all at risk of being misled by the results produced by these tools,” the investigators concluded (N. Engl. J. Med. 2010;362:1014–21).

The findings also suggests that cost profiles based on these methods will not reduce health care spending. “There are serious threats to insurance plans' abilities to achieve cost-control objectives and to patients' expectations of receiving lower-cost care when they change physicians for that purpose,” they added.

This study received support from the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest included support from the Physicians Advocacy Institute, Commonwealth Fund, and Ingenix Inc.

My Take

Abandon Seriously Flawed Programs

The RAND Corporation study verifies the American Medical Association's longstanding contention that there are serious flaws in health insurer programs that attempt to rate physicians based on cost of care.

The RAND study shows that physician ratings conducted by insurers can be wrong up to two-thirds of the time for some groups of physicians. Inaccurate information can erode patient confidence and trust in caring physicians, and disrupt patients' longstanding relationships with physicians who have cared for them for years.

Patients should always be able to trust that the information they receive on physicians is valid and reliable, especially when the data are used by insurers to influence or restrict patients' choice of physicians.

Given the potential for irreparable damage to the patient-physician relationship, the AMA calls on the health insurance industry to abandon flawed physician evaluation and ranking programs, and join with the AMA to create constructive programs that produce meaningful data for increasing the quality and efficiency of health care.

J. JAMES ROHACK, M.D., is president of the American Medical Association. He reported no conflicts of interest.

Current methods for profiling physicians as to whether they provide low- or high-cost care are often inaccurate and produce misleading results, according to a report in the New England Journal of Medicine.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to the physicians whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proved, according to John L. Adams, Ph.D., of Rand Corp., Santa Monica, Calif., and his associates.

“To our knowledge, the reliability of physician cost profiling has not been previously addressed,” they noted.

Dr. Adams and his colleagues assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. The 12,789 physicians included in the study were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years.

The physicians worked in 28 specialties, including endocrinology, cardiology, gastroenterology, and obstetrics and gynecology. Family physicians, general physicians, and internal medicine physicians comprised approximately one-third of the sample.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Overall, 41% of physicians across all specialties had cost profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy. Only 22% of endocrinologists, 47% of internists, 30% of cardiologists, 41% of family or general physicians, 57% of ob.gyns., and 59% of gastroenterologists received scores of 0.70.

Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not lower cost ranged from 29% to 67%, depending on the specialty. Fully 50% of endocrinologists, 50% of internists, 40% of cardiologists, 39% of family or general physicians, 36% of ob.gyns., and 32% of gastroenterologists were misclassified as “lower-cost” providers when they were not.

In addition, 19% of endocrinologists, 22% of internists, 14% of cardiologists, 16% of family or general physicians, 10% of ob.gyns., and 11% of gastroenterologists were misclassified as “higher cost” when they were not in fact higher cost.

These findings indicate that standard methods of cost profiling are highly unreliable, and that many individuals and groups are basing important decisions on inaccuracies. “Consumers, physicians, and purchasers are all at risk of being misled by the results produced by these tools,” the investigators concluded (N. Engl. J. Med. 2010;362:1014–21).

The findings also suggests that cost profiles based on these methods will not reduce health care spending. “There are serious threats to insurance plans' abilities to achieve cost-control objectives and to patients' expectations of receiving lower-cost care when they change physicians for that purpose,” they added.

This study received support from the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest included support from the Physicians Advocacy Institute, Commonwealth Fund, and Ingenix Inc.

My Take

Abandon Seriously Flawed Programs

The RAND Corporation study verifies the American Medical Association's longstanding contention that there are serious flaws in health insurer programs that attempt to rate physicians based on cost of care.

The RAND study shows that physician ratings conducted by insurers can be wrong up to two-thirds of the time for some groups of physicians. Inaccurate information can erode patient confidence and trust in caring physicians, and disrupt patients' longstanding relationships with physicians who have cared for them for years.

Patients should always be able to trust that the information they receive on physicians is valid and reliable, especially when the data are used by insurers to influence or restrict patients' choice of physicians.

Given the potential for irreparable damage to the patient-physician relationship, the AMA calls on the health insurance industry to abandon flawed physician evaluation and ranking programs, and join with the AMA to create constructive programs that produce meaningful data for increasing the quality and efficiency of health care.

J. JAMES ROHACK, M.D., is president of the American Medical Association. He reported no conflicts of interest.

Current methods for profiling physicians as to whether they provide low- or high-cost care are often inaccurate and produce misleading results, according to a report in the New England Journal of Medicine.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to the physicians whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proved, according to John L. Adams, Ph.D., of Rand Corp., Santa Monica, Calif., and his associates.

“To our knowledge, the reliability of physician cost profiling has not been previously addressed,” they noted.

Dr. Adams and his colleagues assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. The 12,789 physicians included in the study were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years.

The physicians worked in 28 specialties, including endocrinology, cardiology, gastroenterology, and obstetrics and gynecology. Family physicians, general physicians, and internal medicine physicians comprised approximately one-third of the sample.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Overall, 41% of physicians across all specialties had cost profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy. Only 22% of endocrinologists, 47% of internists, 30% of cardiologists, 41% of family or general physicians, 57% of ob.gyns., and 59% of gastroenterologists received scores of 0.70.

Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not lower cost ranged from 29% to 67%, depending on the specialty. Fully 50% of endocrinologists, 50% of internists, 40% of cardiologists, 39% of family or general physicians, 36% of ob.gyns., and 32% of gastroenterologists were misclassified as “lower-cost” providers when they were not.

In addition, 19% of endocrinologists, 22% of internists, 14% of cardiologists, 16% of family or general physicians, 10% of ob.gyns., and 11% of gastroenterologists were misclassified as “higher cost” when they were not in fact higher cost.

These findings indicate that standard methods of cost profiling are highly unreliable, and that many individuals and groups are basing important decisions on inaccuracies. “Consumers, physicians, and purchasers are all at risk of being misled by the results produced by these tools,” the investigators concluded (N. Engl. J. Med. 2010;362:1014–21).

The findings also suggests that cost profiles based on these methods will not reduce health care spending. “There are serious threats to insurance plans' abilities to achieve cost-control objectives and to patients' expectations of receiving lower-cost care when they change physicians for that purpose,” they added.

This study received support from the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest included support from the Physicians Advocacy Institute, Commonwealth Fund, and Ingenix Inc.

My Take

Abandon Seriously Flawed Programs

The RAND Corporation study verifies the American Medical Association's longstanding contention that there are serious flaws in health insurer programs that attempt to rate physicians based on cost of care.

The RAND study shows that physician ratings conducted by insurers can be wrong up to two-thirds of the time for some groups of physicians. Inaccurate information can erode patient confidence and trust in caring physicians, and disrupt patients' longstanding relationships with physicians who have cared for them for years.

Patients should always be able to trust that the information they receive on physicians is valid and reliable, especially when the data are used by insurers to influence or restrict patients' choice of physicians.

Given the potential for irreparable damage to the patient-physician relationship, the AMA calls on the health insurance industry to abandon flawed physician evaluation and ranking programs, and join with the AMA to create constructive programs that produce meaningful data for increasing the quality and efficiency of health care.

J. JAMES ROHACK, M.D., is president of the American Medical Association. He reported no conflicts of interest.

Current methods for profiling individual physicians as to whether they provide low-cost or high-cost care are often inaccurate and produce misleading results, according to a report in the New England Journal of Medicine.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to the physicians whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proven, according to John L. Adams, Ph.D., of Rand Corp., Santa Monica, Calif., and his associates.

Dr. Adams and his colleagues assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. A total of 12,789 physicians were included in the study. They were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years.

The physicians worked in 28 specialties, including obstetrics and gynecology, cardiology, endocrinology, and gastroenterology. Family physicians, general physicians, and internists comprised approximately one-third of the sample.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Overall, only 41% of physicians across all specialties had cost profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy. Only 47% of internists, 30% of cardiologists, 41% of family or general physicians, 57% of ob.gyns., 59% of gastroenterologists, and 22% of endocrinologists received scores of 0.70.

Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not in fact lower cost ranged from 29% to 67%, depending on the specialty. Fully 50% of internists, 40% of cardiologists, 39% of family or general physicians, 36% of ob.gyns., 32% of gastroenterologists, and 50% of endocrinologists were misclassified as “lower-cost” providers when they were not.

In addition, 22% of internists were misclassified as “higher cost” when they were not in fact higher cost.

This same misclassification occurred as well for 14% of cardiologists, 16% of family or general physicians, 10% of ob.gyns., 11% of gastroenterologists, and 19% of endocrinologists.

These findings indicate that standard methods of cost profiling are highly unreliable, and that many individuals and groups are basing important decisions on inaccuracies. “Consumers, physicians, and purchasers are all at risk of being misled by the results produced by these tools,” the investigators concluded (N. Engl. J. Med. 2010;362:1014-21).

The study findings also suggest that using cost profiles that are based on these unreliable methods will not reduce health care spending. “There are serious threats to insurance plans' abilities to achieve cost-control objectives and to patients' expectations of receiving lower-cost care when they change physicians for that purpose,” they added.

Disclosures: This study was supported by the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest include support from the Integrated Healthcare Association, American Medical Association, American Board of Medical Specialties, American Board of Internal Medicine Foundation, Massachusetts Medical Society, Physicians Advocacy Institute, and Ingenix Inc.

Current methods for profiling individual physicians as to whether they provide low-cost or high-cost care are often inaccurate and produce misleading results, according to a report in the New England Journal of Medicine.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to the physicians whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proven, according to John L. Adams, Ph.D., of Rand Corp., Santa Monica, Calif., and his associates.

Dr. Adams and his colleagues assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. A total of 12,789 physicians were included in the study. They were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years.

The physicians worked in 28 specialties, including obstetrics and gynecology, cardiology, endocrinology, and gastroenterology. Family physicians, general physicians, and internists comprised approximately one-third of the sample.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Overall, only 41% of physicians across all specialties had cost profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy. Only 47% of internists, 30% of cardiologists, 41% of family or general physicians, 57% of ob.gyns., 59% of gastroenterologists, and 22% of endocrinologists received scores of 0.70.

Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not in fact lower cost ranged from 29% to 67%, depending on the specialty. Fully 50% of internists, 40% of cardiologists, 39% of family or general physicians, 36% of ob.gyns., 32% of gastroenterologists, and 50% of endocrinologists were misclassified as “lower-cost” providers when they were not.

In addition, 22% of internists were misclassified as “higher cost” when they were not in fact higher cost.

This same misclassification occurred as well for 14% of cardiologists, 16% of family or general physicians, 10% of ob.gyns., 11% of gastroenterologists, and 19% of endocrinologists.

These findings indicate that standard methods of cost profiling are highly unreliable, and that many individuals and groups are basing important decisions on inaccuracies. “Consumers, physicians, and purchasers are all at risk of being misled by the results produced by these tools,” the investigators concluded (N. Engl. J. Med. 2010;362:1014-21).

The study findings also suggest that using cost profiles that are based on these unreliable methods will not reduce health care spending. “There are serious threats to insurance plans' abilities to achieve cost-control objectives and to patients' expectations of receiving lower-cost care when they change physicians for that purpose,” they added.

Disclosures: This study was supported by the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest include support from the Integrated Healthcare Association, American Medical Association, American Board of Medical Specialties, American Board of Internal Medicine Foundation, Massachusetts Medical Society, Physicians Advocacy Institute, and Ingenix Inc.

Current methods for profiling individual physicians as to whether they provide low-cost or high-cost care are often inaccurate and produce misleading results, according to a report in the New England Journal of Medicine.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to the physicians whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proven, according to John L. Adams, Ph.D., of Rand Corp., Santa Monica, Calif., and his associates.

Dr. Adams and his colleagues assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. A total of 12,789 physicians were included in the study. They were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years.

The physicians worked in 28 specialties, including obstetrics and gynecology, cardiology, endocrinology, and gastroenterology. Family physicians, general physicians, and internists comprised approximately one-third of the sample.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Overall, only 41% of physicians across all specialties had cost profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy. Only 47% of internists, 30% of cardiologists, 41% of family or general physicians, 57% of ob.gyns., 59% of gastroenterologists, and 22% of endocrinologists received scores of 0.70.

Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not in fact lower cost ranged from 29% to 67%, depending on the specialty. Fully 50% of internists, 40% of cardiologists, 39% of family or general physicians, 36% of ob.gyns., 32% of gastroenterologists, and 50% of endocrinologists were misclassified as “lower-cost” providers when they were not.

In addition, 22% of internists were misclassified as “higher cost” when they were not in fact higher cost.

This same misclassification occurred as well for 14% of cardiologists, 16% of family or general physicians, 10% of ob.gyns., 11% of gastroenterologists, and 19% of endocrinologists.

These findings indicate that standard methods of cost profiling are highly unreliable, and that many individuals and groups are basing important decisions on inaccuracies. “Consumers, physicians, and purchasers are all at risk of being misled by the results produced by these tools,” the investigators concluded (N. Engl. J. Med. 2010;362:1014-21).

The study findings also suggest that using cost profiles that are based on these unreliable methods will not reduce health care spending. “There are serious threats to insurance plans' abilities to achieve cost-control objectives and to patients' expectations of receiving lower-cost care when they change physicians for that purpose,” they added.

Disclosures: This study was supported by the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest include support from the Integrated Healthcare Association, American Medical Association, American Board of Medical Specialties, American Board of Internal Medicine Foundation, Massachusetts Medical Society, Physicians Advocacy Institute, and Ingenix Inc.

Most primary care practices are not large enough for significant differences in performance to be assessed using national quality and cost benchmarks, according to a report in JAMA.

Nationally, fewer than 2% of all primary care practices were able to be reliably assessed because their caseloads were too small. Even when their case loads were pooled with those of other physicians in the practice, and even if 2-3 years' worth of cases were included, the numbers were too small to reliably assess quality, according to David J. Nyweide, Ph.D., of the Centers for Medicare and Medicaid Services and his associates.

The CMS has “been overseeing a series of value-based purchasing initiatives,” including pay-for-performance projects and the Physician Quality Reporting Initiative.

Dr. Nyweide and his colleagues questioned whether individual physicians see a sufficient number of patients with various disorders such that their performance can be judged against commonly used quality and cost measures.

Using national mean ambulatory Medicare spending data, the researchers calculated the caseloads that would be necessary to detect meaningful differences on each commonly used performance measure, including rates at which 66- to 69-year-old women received mammography, rates of hemoglobin A_1c testing for diabetics aged 65-75 years, rates of preventable hospitalizations associated with 13 specific adult conditions, and rates of hospital readmission for heart failure patients.

In all, 71,980 primary care physicians who were affiliated with 30,794 practices were included in the study. Most of the practices (61%) were solo. Caseloads ranged from a median of 170 patients for solo practitioners to 13,400 for practices with more than 50 primary care physicians.

The investigators found that “only the largest primary care physician practices, which are also the most uncommon, can be expected to have sufficient caseloads to measure significant differences in performance.”

A year-long caseload of 328 women aged 66-69 years old would be needed to detect a 10% difference in the rate of mammography for that age group, and 19,069 patients would be needed to reliably detect a 10% difference in the rate of preventable hospitalizations.

Overall, fewer than 2% of the practices could be reliably compared on any of the performance measures.

Even grouping caseloads by 2-year and 3-year periods failed to amass sufficient sample sizes for reliable comparisons among practices.

“The results from this study call into question the wisdom of pay-for-performance programs and quality reporting initiatives that focus on differentiating the value of care delivered to the Medicare population by primary care physicians,” Dr. Nyweide and his colleagues wrote (JAMA 2009;302:2444-50).

Disclosures: None was reported.

Most primary care practices are not large enough for significant differences in performance to be assessed using national quality and cost benchmarks, according to a report in JAMA.

Nationally, fewer than 2% of all primary care practices were able to be reliably assessed because their caseloads were too small. Even when their case loads were pooled with those of other physicians in the practice, and even if 2-3 years' worth of cases were included, the numbers were too small to reliably assess quality, according to David J. Nyweide, Ph.D., of the Centers for Medicare and Medicaid Services and his associates.

The CMS has “been overseeing a series of value-based purchasing initiatives,” including pay-for-performance projects and the Physician Quality Reporting Initiative.

Dr. Nyweide and his colleagues questioned whether individual physicians see a sufficient number of patients with various disorders such that their performance can be judged against commonly used quality and cost measures.

Using national mean ambulatory Medicare spending data, the researchers calculated the caseloads that would be necessary to detect meaningful differences on each commonly used performance measure, including rates at which 66- to 69-year-old women received mammography, rates of hemoglobin A_1c testing for diabetics aged 65-75 years, rates of preventable hospitalizations associated with 13 specific adult conditions, and rates of hospital readmission for heart failure patients.

In all, 71,980 primary care physicians who were affiliated with 30,794 practices were included in the study. Most of the practices (61%) were solo. Caseloads ranged from a median of 170 patients for solo practitioners to 13,400 for practices with more than 50 primary care physicians.

The investigators found that “only the largest primary care physician practices, which are also the most uncommon, can be expected to have sufficient caseloads to measure significant differences in performance.”

A year-long caseload of 328 women aged 66-69 years old would be needed to detect a 10% difference in the rate of mammography for that age group, and 19,069 patients would be needed to reliably detect a 10% difference in the rate of preventable hospitalizations.

Overall, fewer than 2% of the practices could be reliably compared on any of the performance measures.

Even grouping caseloads by 2-year and 3-year periods failed to amass sufficient sample sizes for reliable comparisons among practices.

“The results from this study call into question the wisdom of pay-for-performance programs and quality reporting initiatives that focus on differentiating the value of care delivered to the Medicare population by primary care physicians,” Dr. Nyweide and his colleagues wrote (JAMA 2009;302:2444-50).

Disclosures: None was reported.

Most primary care practices are not large enough for significant differences in performance to be assessed using national quality and cost benchmarks, according to a report in JAMA.

Nationally, fewer than 2% of all primary care practices were able to be reliably assessed because their caseloads were too small. Even when their case loads were pooled with those of other physicians in the practice, and even if 2-3 years' worth of cases were included, the numbers were too small to reliably assess quality, according to David J. Nyweide, Ph.D., of the Centers for Medicare and Medicaid Services and his associates.

The CMS has “been overseeing a series of value-based purchasing initiatives,” including pay-for-performance projects and the Physician Quality Reporting Initiative.

Dr. Nyweide and his colleagues questioned whether individual physicians see a sufficient number of patients with various disorders such that their performance can be judged against commonly used quality and cost measures.

Using national mean ambulatory Medicare spending data, the researchers calculated the caseloads that would be necessary to detect meaningful differences on each commonly used performance measure, including rates at which 66- to 69-year-old women received mammography, rates of hemoglobin A_1c testing for diabetics aged 65-75 years, rates of preventable hospitalizations associated with 13 specific adult conditions, and rates of hospital readmission for heart failure patients.

In all, 71,980 primary care physicians who were affiliated with 30,794 practices were included in the study. Most of the practices (61%) were solo. Caseloads ranged from a median of 170 patients for solo practitioners to 13,400 for practices with more than 50 primary care physicians.

The investigators found that “only the largest primary care physician practices, which are also the most uncommon, can be expected to have sufficient caseloads to measure significant differences in performance.”

A year-long caseload of 328 women aged 66-69 years old would be needed to detect a 10% difference in the rate of mammography for that age group, and 19,069 patients would be needed to reliably detect a 10% difference in the rate of preventable hospitalizations.

Overall, fewer than 2% of the practices could be reliably compared on any of the performance measures.

Even grouping caseloads by 2-year and 3-year periods failed to amass sufficient sample sizes for reliable comparisons among practices.

“The results from this study call into question the wisdom of pay-for-performance programs and quality reporting initiatives that focus on differentiating the value of care delivered to the Medicare population by primary care physicians,” Dr. Nyweide and his colleagues wrote (JAMA 2009;302:2444-50).

Disclosures: None was reported.

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to a report in JAMA.

While the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid-1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical workweeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical workforce, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults. They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977-1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

Disclosures: This study was supported by the National Institutes of Health. Dr. Staiger and his associates reported no financial conflicts of interest.

Physicians have shortened their typical workweeks in the last decade, unlike other professionals.

Source ©Udo Kroener/Fotolia.com

My Take

A Gathering Storm

This study on the decline in hours worked per week by physicians highlights a gathering storm in the field of primary care medicine. This finding comes at a time when hospitals are under increasing pressure to decrease the workload and hours worked by residents—and by extension—practicing physicians.

The other development contributing to this inclement outlook is that the health care reform legislation recently passed the U.S. Congress and signed by President Obama will soon be adding 32 million previously uninsured Americans to the national health care equation.

We therefore desperately need to ramp up our education and training of new physicians, especially those who want to practice primary care in underserved communities. However, this will take time because medical schools cannot just expand their class size without adding significant numbers of new faculty and other resources.

In the meantime, we will have to greatly expand the use of and responsibilities of allied health care professionals, such as physician's assistants and nurse midwives, to help fill the void until medical schools such as ours can greatly expand our class size. Although there is currently a shortage of allied health care professionals in the United States as well, it will nevertheless be easier to increase our output of these professionals in the short term than it will be to increase our output of physicians.

Thus, to avert this gathering storm of health care worker shortages, we must train more allied health care professionals in the short term, while in the long term we will need to significantly expand training of high-quality, committed primary care physicians.

DR. E. ALBERT REECE, Ph.D., M.B.A., who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of its school of medicine.

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to a report in JAMA.

While the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid-1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical workweeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical workforce, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults. They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977-1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

Disclosures: This study was supported by the National Institutes of Health. Dr. Staiger and his associates reported no financial conflicts of interest.

Physicians have shortened their typical workweeks in the last decade, unlike other professionals.

Source ©Udo Kroener/Fotolia.com

My Take

A Gathering Storm

This study on the decline in hours worked per week by physicians highlights a gathering storm in the field of primary care medicine. This finding comes at a time when hospitals are under increasing pressure to decrease the workload and hours worked by residents—and by extension—practicing physicians.

The other development contributing to this inclement outlook is that the health care reform legislation recently passed the U.S. Congress and signed by President Obama will soon be adding 32 million previously uninsured Americans to the national health care equation.

We therefore desperately need to ramp up our education and training of new physicians, especially those who want to practice primary care in underserved communities. However, this will take time because medical schools cannot just expand their class size without adding significant numbers of new faculty and other resources.

In the meantime, we will have to greatly expand the use of and responsibilities of allied health care professionals, such as physician's assistants and nurse midwives, to help fill the void until medical schools such as ours can greatly expand our class size. Although there is currently a shortage of allied health care professionals in the United States as well, it will nevertheless be easier to increase our output of these professionals in the short term than it will be to increase our output of physicians.

Thus, to avert this gathering storm of health care worker shortages, we must train more allied health care professionals in the short term, while in the long term we will need to significantly expand training of high-quality, committed primary care physicians.

DR. E. ALBERT REECE, Ph.D., M.B.A., who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of its school of medicine.

The number of hours U.S. physicians work each week has markedly and steadily decreased during the past decade, after having remained stable during the 2 preceding decades, according to a report in JAMA.

While the study was not designed to identify why such changes have occurred, investigators did find a striking correlation between physicians' decreasing hours and decreasing fees for their services. Inflation-adjusted physician fees changed little until the mid-1990s, when they began a steady 10-year decline. “By 2006, physician fees were 25% lower than their inflation-adjusted 1995 levels,” Douglas O. Staiger, Ph.D., of Dartmouth College, Hanover, N.H., and his colleagues noted.

The decrease in hours worked per week “was broad based and not concentrated among physicians with particular demographic characteristics or working in particular settings.” Physicians from all demographic areas have shortened their typical workweeks from the approximately 55 hours that prevailed since 1977 to 51 hours, the investigators said.

In contrast, mean weekly hours worked by other professionals such as lawyers, engineers, and registered nurses “changed very little during the past 30 years, which is consistent with national trends in mean weekly hours among all workers published by the Bureau of Labor Statistics,” they said.

The researchers said they examined this issue because most studies concerning the medical workforce, as well as the policy decisions based on those studies, have assumed that hours worked by physicians have remained constant. A few recent studies have suggested that this assumption may no longer be warranted.

Dr. Staiger and his colleagues analyzed data from the Census Bureau's Current Population Survey, an annual report that obtains detailed information about employment from a nationally representative sample of adults. They examined data from the late 1970s through 2008 on all 116,733 survey subjects listed as physicians or surgeons.

Physician weekly work hours were stable during 1977-1997, ranging only from a low of 54.6 hours to a high of 55.9. Since then, however, work hours have declined steadily, and they currently total 51 hours per week.

During the same interval, mean physician fees, adjusted for inflation, decreased by 25%. “It is likely that a third factor that was associated with lower fees, such as growing managed care penetration or market competition, may have contributed to the decrease in physician hours,” Dr. Staiger and his colleagues noted (JAMA 2010;303:747-53).

“Whatever the underlying cause, the decrease … raises implications for physician workforce supply and overall health care policy. A 5.7% decrease in hours worked by nonresident physicians in patient care, out of a workforce of approximately 630,000 in 2007, is equivalent to a loss of approximately 36,000 physicians from the workforce.

“Although the number of physicians has nearly doubled during the last 30 years, many workforce analysts and professional organizations are concerned about the adequacy of the size of the future physician workforce. This trend toward lower hours, if it continues, will make expanding or maintaining current levels of physician supply more difficult,” they noted.

The trend also “could frustrate stated goals of health reform, which may require an expanded physician workforce to take on new roles and enhanced functions in a reformed delivery system.”

Disclosures: This study was supported by the National Institutes of Health. Dr. Staiger and his associates reported no financial conflicts of interest.

Physicians have shortened their typical workweeks in the last decade, unlike other professionals.

Source ©Udo Kroener/Fotolia.com

My Take

A Gathering Storm

This study on the decline in hours worked per week by physicians highlights a gathering storm in the field of primary care medicine. This finding comes at a time when hospitals are under increasing pressure to decrease the workload and hours worked by residents—and by extension—practicing physicians.

The other development contributing to this inclement outlook is that the health care reform legislation recently passed the U.S. Congress and signed by President Obama will soon be adding 32 million previously uninsured Americans to the national health care equation.

We therefore desperately need to ramp up our education and training of new physicians, especially those who want to practice primary care in underserved communities. However, this will take time because medical schools cannot just expand their class size without adding significant numbers of new faculty and other resources.

In the meantime, we will have to greatly expand the use of and responsibilities of allied health care professionals, such as physician's assistants and nurse midwives, to help fill the void until medical schools such as ours can greatly expand our class size. Although there is currently a shortage of allied health care professionals in the United States as well, it will nevertheless be easier to increase our output of these professionals in the short term than it will be to increase our output of physicians.

Thus, to avert this gathering storm of health care worker shortages, we must train more allied health care professionals in the short term, while in the long term we will need to significantly expand training of high-quality, committed primary care physicians.

DR. E. ALBERT REECE, Ph.D., M.B.A., who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of its school of medicine.

A review of the recent literature confirms that “comparative effectiveness” research—studies designed to help physicians use existing treatments more effectively—is severely lacking.

Fewer than a third of the studies published in the six top journals qualified as comparative effectiveness (CE) research. This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Mass.) Health Alliance and Harvard Medical School, Boston.

Congress recently passed legislation to provide more than $1 billion to support CE studies, and President Obama's budget for 2011 recommends further funding of CE research. Noting that few data are available on the current status of CE research, the investigators reviewed all clinical medication-assessment studies published between June 2008 and October 2009 in the New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine. These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951–8).

Of the 328 randomized trials, observational studies, or meta-analyses, only 104 (32%) were CE studies. Only 11% of the CE studies compared medications with nonpharmacologic treatments, confirming a relative lack of such research. Such studies are important because they help clinicians “make fundamental therapeutic decisions,” the investigators said.

Nearly 90% of the CE studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is. “Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results. In addition, 24% of the randomized trials that did use an active comparator sought to demonstrate only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Only 19% of the CE studies focused on patient safety, which implies that safety concerns are not adequately emphasized in medication studies.

Only 2% of the CE studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for CE studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

Disclosures: The investigators reported no financial conflicts of interest.

A review of the recent literature confirms that “comparative effectiveness” research—studies designed to help physicians use existing treatments more effectively—is severely lacking.

Fewer than a third of the studies published in the six top journals qualified as comparative effectiveness (CE) research. This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Mass.) Health Alliance and Harvard Medical School, Boston.

Congress recently passed legislation to provide more than $1 billion to support CE studies, and President Obama's budget for 2011 recommends further funding of CE research. Noting that few data are available on the current status of CE research, the investigators reviewed all clinical medication-assessment studies published between June 2008 and October 2009 in the New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine. These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951–8).

Of the 328 randomized trials, observational studies, or meta-analyses, only 104 (32%) were CE studies. Only 11% of the CE studies compared medications with nonpharmacologic treatments, confirming a relative lack of such research. Such studies are important because they help clinicians “make fundamental therapeutic decisions,” the investigators said.

Nearly 90% of the CE studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is. “Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results. In addition, 24% of the randomized trials that did use an active comparator sought to demonstrate only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Only 19% of the CE studies focused on patient safety, which implies that safety concerns are not adequately emphasized in medication studies.

Only 2% of the CE studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for CE studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

Disclosures: The investigators reported no financial conflicts of interest.

A review of the recent literature confirms that “comparative effectiveness” research—studies designed to help physicians use existing treatments more effectively—is severely lacking.

Fewer than a third of the studies published in the six top journals qualified as comparative effectiveness (CE) research. This finding “supports concerns that only limited clinical research is currently devoted to helping physicians” improve the use of existing therapies and determine which interventions and strategies are the most effective and safe, and the least costly, said Dr. Michael Hochman and Dr. Danny McCormick of Cambridge (Mass.) Health Alliance and Harvard Medical School, Boston.

Congress recently passed legislation to provide more than $1 billion to support CE studies, and President Obama's budget for 2011 recommends further funding of CE research. Noting that few data are available on the current status of CE research, the investigators reviewed all clinical medication-assessment studies published between June 2008 and October 2009 in the New England Journal of Medicine, Lancet, JAMA, Annals of Internal Medicine, British Medical Journal, and Archives of Internal Medicine. These publications “are the most widely read, quoted, and covered by the media, and thus are disproportionately likely to influence clinicians,” the investigators said (JAMA 2010;303:951–8).

Of the 328 randomized trials, observational studies, or meta-analyses, only 104 (32%) were CE studies. Only 11% of the CE studies compared medications with nonpharmacologic treatments, confirming a relative lack of such research. Such studies are important because they help clinicians “make fundamental therapeutic decisions,” the investigators said.

Nearly 90% of the CE studies relied on noncommercial funding, primarily from government sources, a finding that highlights how essential such funding is. “Commercial entities presumably devote much of their research to the development of novel therapies and to funding inactive-comparator studies aimed at expanding indications for their products,” they noted.

More than half of the randomized trials in this analysis used an “inactive comparator” such as placebo, rather than comparing a medication against existing treatments. Such trials were disproportionately funded by commercial sources and were disproportionately likely to show that a medication produced positive results. In addition, 24% of the randomized trials that did use an active comparator sought to demonstrate only the noninferiority of a medication to that comparator; there was no effort to clarify the optimal therapy, only to test equivalency. Such trials were exclusively funded by commercial sources.

Only 19% of the CE studies focused on patient safety, which implies that safety concerns are not adequately emphasized in medication studies.

Only 2% of the CE studies and 1% of all studies in the analysis included formal cost-effectiveness analyses, which are critical to promoting efficient health care.

Overall, the findings “underscore the importance of the recent legislation passed in the United States to expand public funding for CE studies. In particular, our findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies,” Dr. Hochman and Dr. McCormick said.

Disclosures: The investigators reported no financial conflicts of interest.

Current methods for profiling individual physicians as to whether they provide low-cost or high-cost care are often inaccurate and produce misleading results, according to data from a recent Rand Corp. study.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to those whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proved, according to John L. Adams, Ph.D., of Rand Corp. and his associates.

The investigators assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. In all, 12,789 physicians were included in the study.

They were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years. The physicians worked in 28 specialties.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Only 41% of physicians across all specialties had cost-profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy (N. Engl. J. Med. 2010;362:1014–21). Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not in fact lower cost ranged from 29% to 67%, depending on the specialty.

Disclosures: This study was supported by the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest include support from the Integrated Healthcare Association, American Medical Association, American Board of Medical Specialties, Arkansas Medical Society, American Board of Internal Medicine Foundation, Massachusetts Medical Society, Physicians Advocacy Institute, Commonwealth Fund, and Ingenix Inc.

My Take

Abandon Flawed Evaluation Programs

The Rand study verifies the American Medical Association's longstanding contention that there are serious flaws in health insurer programs that attempt to rate physicians based on cost of care.

The study shows that such ratings can be wrong up to two-thirds of the time for some groups of physicians. Inaccurate information can erode patient confidence and trust in caring physicians, and disrupt patients' longstanding relationships with physicians who have cared for them for years.

Patients should always be able to trust that the information they receive on physicians is valid and reliable, especially when the data are used by insurers to influence or restrict patients' choice of physicians.

Given the potential for irreparable damage to the patient-physician relationship, the AMA calls on the health insurance industry to abandon flawed physician evaluation and ranking programs, and join with us to create constructive programs that produce meaningful data for increasing the quality and efficiency of health care.

J. JAMES ROHACK, M.D., is president of the American Medical Association. He reported no conflicts of interest.

Current methods for profiling individual physicians as to whether they provide low-cost or high-cost care are often inaccurate and produce misleading results, according to data from a recent Rand Corp. study.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to those whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proved, according to John L. Adams, Ph.D., of Rand Corp. and his associates.

The investigators assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. In all, 12,789 physicians were included in the study.

They were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years. The physicians worked in 28 specialties.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Only 41% of physicians across all specialties had cost-profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy (N. Engl. J. Med. 2010;362:1014–21). Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not in fact lower cost ranged from 29% to 67%, depending on the specialty.

Disclosures: This study was supported by the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest include support from the Integrated Healthcare Association, American Medical Association, American Board of Medical Specialties, Arkansas Medical Society, American Board of Internal Medicine Foundation, Massachusetts Medical Society, Physicians Advocacy Institute, Commonwealth Fund, and Ingenix Inc.

My Take

Abandon Flawed Evaluation Programs

The Rand study verifies the American Medical Association's longstanding contention that there are serious flaws in health insurer programs that attempt to rate physicians based on cost of care.

The study shows that such ratings can be wrong up to two-thirds of the time for some groups of physicians. Inaccurate information can erode patient confidence and trust in caring physicians, and disrupt patients' longstanding relationships with physicians who have cared for them for years.

Patients should always be able to trust that the information they receive on physicians is valid and reliable, especially when the data are used by insurers to influence or restrict patients' choice of physicians.

Given the potential for irreparable damage to the patient-physician relationship, the AMA calls on the health insurance industry to abandon flawed physician evaluation and ranking programs, and join with us to create constructive programs that produce meaningful data for increasing the quality and efficiency of health care.

J. JAMES ROHACK, M.D., is president of the American Medical Association. He reported no conflicts of interest.

Current methods for profiling individual physicians as to whether they provide low-cost or high-cost care are often inaccurate and produce misleading results, according to data from a recent Rand Corp. study.

Health plans use cost profiling to limit how many physicians get in-network contracts and to allot bonuses to those whose “resource use” is lower than average. In each case, there must be a method for determining physicians' costs, yet the accuracy of these methods has never been proved, according to John L. Adams, Ph.D., of Rand Corp. and his associates.

The investigators assessed the reliability of current methods of cost profiling using claims data from four Massachusetts insurance companies concerning 1.1 million adult patients treated during 2004-2005. In all, 12,789 physicians were included in the study.

They were predominantly men who were board certified, had been trained in the United States, and had been in practice for more than 10 years. The physicians worked in 28 specialties.

The investigators estimated the reliability of cost profiles on a scale of 0-1, with 0 representing completely unreliable profiles and 1 representing completely reliable profiles. They then estimated the proportion of physicians in each specialty whose cost performance would be calculated inaccurately.

Only 41% of physicians across all specialties had cost-profile scores of 0.70 or greater, a commonly used threshold of acceptable accuracy (N. Engl. J. Med. 2010;362:1014–21). Overall, only 9% of physicians in the study had scores of 0.90 or greater, indicating optimal accuracy.

The proportion of physicians who were classified as “lower cost” but who were not in fact lower cost ranged from 29% to 67%, depending on the specialty.

Disclosures: This study was supported by the Department of Labor, the National Institutes of Health, and the Robert Wood Johnson Foundation. The investigators' conflicts of interest include support from the Integrated Healthcare Association, American Medical Association, American Board of Medical Specialties, Arkansas Medical Society, American Board of Internal Medicine Foundation, Massachusetts Medical Society, Physicians Advocacy Institute, Commonwealth Fund, and Ingenix Inc.

My Take

Abandon Flawed Evaluation Programs

The Rand study verifies the American Medical Association's longstanding contention that there are serious flaws in health insurer programs that attempt to rate physicians based on cost of care.

The study shows that such ratings can be wrong up to two-thirds of the time for some groups of physicians. Inaccurate information can erode patient confidence and trust in caring physicians, and disrupt patients' longstanding relationships with physicians who have cared for them for years.

Patients should always be able to trust that the information they receive on physicians is valid and reliable, especially when the data are used by insurers to influence or restrict patients' choice of physicians.

Given the potential for irreparable damage to the patient-physician relationship, the AMA calls on the health insurance industry to abandon flawed physician evaluation and ranking programs, and join with us to create constructive programs that produce meaningful data for increasing the quality and efficiency of health care.

J. JAMES ROHACK, M.D., is president of the American Medical Association. He reported no conflicts of interest.

Nateglinide failed to prevent the development of diabetes and related CV events in high-risk patients in a large international clinical trial.

In the same trial, the angiotensin-receptor blocker valsartan also failed to prevent CV events. However, valsartan induced an unexpected relative reduction of 14% in the incidence of diabetes, according to the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Study Group.

The results were published simultaneously their at the annual meeting of the American College of Cardiology in Atlanta.

In an editorial accompanying the two reports, Dr. David M. Nathan of Massachusetts General Hospital's Diabetes Center, Boston, said, “The authors suggest that the prevention of diabetes with valsartan might make it a preferred drug as compared with antihypertensive drugs that potentially worsen glycemia.”

However, this trial's single positive finding was only a “weak” reduction in diabetes with valsartan—not enough to support such a recommendation. The totality of the study findings show instead that “for now we should steer away from these two drugs” when attempting to forestall diabetes and its associated cardiovascular complications in high-risk patients, Dr. Nathan said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMe1002322]).

In NAVIGATOR, 9,306 patients who had impaired glucose tolerance and either known cardiovascular disease or CV risk factors were assessed at 806 medical centers in 40 countries during January 2002–January 2004. They were randomly assigned to take 60 mg of the insulin secretagogue nateglinide before meals three times daily, a placebo, or in a 2-by-2 factorial design, oral valsartan or placebo.

All the study subjects also were required to participate in a lifestyle modification program aimed at achieving a 5% weight loss, reduced dietary fats, and increased physical activity.

Nateglinide, which lowers postprandial glucose, was studied to determine whether it would slow progression to diabetes by restoring a more physiologic insulin response to meals. But during a mean follow-up of about 6 years, progression to diabetes occurred in 36% of the nateglinide group and 34% of the placebo group, a nonsignificant difference, said Dr. Rury R. Holman of Oxford (England) University's Centre for Diabetes, Endocrinology, and Metabolism, and his associates said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMoa1001122]).

Similarly, a composite cardiovascular outcome event occurred in 14% of the nateglinide group and 15% of the placebo group. There also were no differences between the two groups in any of the individual components of the composite CV outcome, including mortality rates.

The valsartan results, reported in a separate article, showed that the ARB had no effect on combined CV outcomes. Furthermore, it reduced the incidence of diabetes by 14% relative to placebo. This “would translate into 38 fewer cases of diabetes per 1,000 patients treated for 5 years,” said Dr. Robert M. Califf of the Duke Translational Medicine Institute in Durham, N.C., and his NAVIGATOR colleagues.

It is possible that valsartan did not improve CV outcomes as it should have because most risk factors were already well controlled, since study subjects were allowed to take nonstudy medications such as ACE inhibitors, they said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMoa1001121]).

In his editorial comment, Dr. Nathan agreed that “the high rates of loss to follow-up (13%), use of off-study ACE inhibitors or ARBs among participants assigned to placebo (24%), and nonadherence to valsartan (34% by study end) could explain the absence of an effect on cardiovascular disease.”

Overall, the NAVIGATOR results “do not support the contention that reducing postprandial hyperglycemia has a specific role in preventing diabetes or reducing cardiovascular disease. Other than increasing the rate of hypoglycemia by a factor of two, nateglinide had little effect,” Dr. Nathan commented.

The study was sponsored and designed by Novartis Pharma, manufacturer of both drugs. Novartis also collected, managed, and analyzed the data. In addition to support from Novartis, the NAVIGATOR researchers reported receiving financial support from Sanofi-Aventis and Merck. Dr. Nathan reported no financial conflicts of interest.

My Take

RAS Inhibition, Lifestyle Modification Affirmed

The NAVIGATOR trial was an ambitious effort to assess the ability of nateglinide and valsartan to prevent the onset of diabetes and adverse cardiovascular outcomes. Given our growing diabetes epidemic, meaningfully positive findings for either outcome with either intervention would have been welcome.

Unfortunately, both treatments were disappointing with regard to each of the co-primary end points. Furthermore, nateglinide was also linked to greater weight gain and increase in waist circumference, likely foreboding a higher rate of future diabetes.

Although valsartan did not prevent CV events or any of its other component events, it was associated with a significantly lower incidence of new onset diabetes, compared with placebo.

Similar reductions have been noted with other inhibitors of the renin-angiotensin system, but these are far less impressive than those seen with successful life-style modifications or metformin, which reduced the onset of type II diabetes in similar patients in the Diabetes Prevention Program by 58% and 31%, respectively (N. Engl. J. Med. 2002;346:393-403).

It now appears that the goal of diabetes prevention is best addressed by changing behavior, and with the hope that improvements in cardiovascular (CV) outcomes will follow.

Until then, it seems reasonable to use an inhibitor of the RAS system as part of the antihypertensive regimen that most prediabetic and diabetic patients will need.

DR. BARRY MASSIE is professor of medicine at the University of California, San Francisco, and chief of cardiology at the San Francisco Veterans Affairs Medical Center. He has financial relationships with Novartis, Merck, and Cytokinetics, among other pharmaceutical companies.

Nateglinide failed to prevent the development of diabetes and related CV events in high-risk patients in a large international clinical trial.

In the same trial, the angiotensin-receptor blocker valsartan also failed to prevent CV events. However, valsartan induced an unexpected relative reduction of 14% in the incidence of diabetes, according to the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Study Group.

The results were published simultaneously their at the annual meeting of the American College of Cardiology in Atlanta.

In an editorial accompanying the two reports, Dr. David M. Nathan of Massachusetts General Hospital's Diabetes Center, Boston, said, “The authors suggest that the prevention of diabetes with valsartan might make it a preferred drug as compared with antihypertensive drugs that potentially worsen glycemia.”

However, this trial's single positive finding was only a “weak” reduction in diabetes with valsartan—not enough to support such a recommendation. The totality of the study findings show instead that “for now we should steer away from these two drugs” when attempting to forestall diabetes and its associated cardiovascular complications in high-risk patients, Dr. Nathan said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMe1002322]).

In NAVIGATOR, 9,306 patients who had impaired glucose tolerance and either known cardiovascular disease or CV risk factors were assessed at 806 medical centers in 40 countries during January 2002–January 2004. They were randomly assigned to take 60 mg of the insulin secretagogue nateglinide before meals three times daily, a placebo, or in a 2-by-2 factorial design, oral valsartan or placebo.

All the study subjects also were required to participate in a lifestyle modification program aimed at achieving a 5% weight loss, reduced dietary fats, and increased physical activity.

Nateglinide, which lowers postprandial glucose, was studied to determine whether it would slow progression to diabetes by restoring a more physiologic insulin response to meals. But during a mean follow-up of about 6 years, progression to diabetes occurred in 36% of the nateglinide group and 34% of the placebo group, a nonsignificant difference, said Dr. Rury R. Holman of Oxford (England) University's Centre for Diabetes, Endocrinology, and Metabolism, and his associates said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMoa1001122]).

Similarly, a composite cardiovascular outcome event occurred in 14% of the nateglinide group and 15% of the placebo group. There also were no differences between the two groups in any of the individual components of the composite CV outcome, including mortality rates.

The valsartan results, reported in a separate article, showed that the ARB had no effect on combined CV outcomes. Furthermore, it reduced the incidence of diabetes by 14% relative to placebo. This “would translate into 38 fewer cases of diabetes per 1,000 patients treated for 5 years,” said Dr. Robert M. Califf of the Duke Translational Medicine Institute in Durham, N.C., and his NAVIGATOR colleagues.

It is possible that valsartan did not improve CV outcomes as it should have because most risk factors were already well controlled, since study subjects were allowed to take nonstudy medications such as ACE inhibitors, they said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMoa1001121]).

In his editorial comment, Dr. Nathan agreed that “the high rates of loss to follow-up (13%), use of off-study ACE inhibitors or ARBs among participants assigned to placebo (24%), and nonadherence to valsartan (34% by study end) could explain the absence of an effect on cardiovascular disease.”

Overall, the NAVIGATOR results “do not support the contention that reducing postprandial hyperglycemia has a specific role in preventing diabetes or reducing cardiovascular disease. Other than increasing the rate of hypoglycemia by a factor of two, nateglinide had little effect,” Dr. Nathan commented.

The study was sponsored and designed by Novartis Pharma, manufacturer of both drugs. Novartis also collected, managed, and analyzed the data. In addition to support from Novartis, the NAVIGATOR researchers reported receiving financial support from Sanofi-Aventis and Merck. Dr. Nathan reported no financial conflicts of interest.

My Take

RAS Inhibition, Lifestyle Modification Affirmed

The NAVIGATOR trial was an ambitious effort to assess the ability of nateglinide and valsartan to prevent the onset of diabetes and adverse cardiovascular outcomes. Given our growing diabetes epidemic, meaningfully positive findings for either outcome with either intervention would have been welcome.

Unfortunately, both treatments were disappointing with regard to each of the co-primary end points. Furthermore, nateglinide was also linked to greater weight gain and increase in waist circumference, likely foreboding a higher rate of future diabetes.

Although valsartan did not prevent CV events or any of its other component events, it was associated with a significantly lower incidence of new onset diabetes, compared with placebo.

Similar reductions have been noted with other inhibitors of the renin-angiotensin system, but these are far less impressive than those seen with successful life-style modifications or metformin, which reduced the onset of type II diabetes in similar patients in the Diabetes Prevention Program by 58% and 31%, respectively (N. Engl. J. Med. 2002;346:393-403).

It now appears that the goal of diabetes prevention is best addressed by changing behavior, and with the hope that improvements in cardiovascular (CV) outcomes will follow.

Until then, it seems reasonable to use an inhibitor of the RAS system as part of the antihypertensive regimen that most prediabetic and diabetic patients will need.

DR. BARRY MASSIE is professor of medicine at the University of California, San Francisco, and chief of cardiology at the San Francisco Veterans Affairs Medical Center. He has financial relationships with Novartis, Merck, and Cytokinetics, among other pharmaceutical companies.

Nateglinide failed to prevent the development of diabetes and related CV events in high-risk patients in a large international clinical trial.

In the same trial, the angiotensin-receptor blocker valsartan also failed to prevent CV events. However, valsartan induced an unexpected relative reduction of 14% in the incidence of diabetes, according to the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Study Group.

The results were published simultaneously their at the annual meeting of the American College of Cardiology in Atlanta.

In an editorial accompanying the two reports, Dr. David M. Nathan of Massachusetts General Hospital's Diabetes Center, Boston, said, “The authors suggest that the prevention of diabetes with valsartan might make it a preferred drug as compared with antihypertensive drugs that potentially worsen glycemia.”

However, this trial's single positive finding was only a “weak” reduction in diabetes with valsartan—not enough to support such a recommendation. The totality of the study findings show instead that “for now we should steer away from these two drugs” when attempting to forestall diabetes and its associated cardiovascular complications in high-risk patients, Dr. Nathan said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMe1002322]).

In NAVIGATOR, 9,306 patients who had impaired glucose tolerance and either known cardiovascular disease or CV risk factors were assessed at 806 medical centers in 40 countries during January 2002–January 2004. They were randomly assigned to take 60 mg of the insulin secretagogue nateglinide before meals three times daily, a placebo, or in a 2-by-2 factorial design, oral valsartan or placebo.

All the study subjects also were required to participate in a lifestyle modification program aimed at achieving a 5% weight loss, reduced dietary fats, and increased physical activity.

Nateglinide, which lowers postprandial glucose, was studied to determine whether it would slow progression to diabetes by restoring a more physiologic insulin response to meals. But during a mean follow-up of about 6 years, progression to diabetes occurred in 36% of the nateglinide group and 34% of the placebo group, a nonsignificant difference, said Dr. Rury R. Holman of Oxford (England) University's Centre for Diabetes, Endocrinology, and Metabolism, and his associates said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMoa1001122]).

Similarly, a composite cardiovascular outcome event occurred in 14% of the nateglinide group and 15% of the placebo group. There also were no differences between the two groups in any of the individual components of the composite CV outcome, including mortality rates.

The valsartan results, reported in a separate article, showed that the ARB had no effect on combined CV outcomes. Furthermore, it reduced the incidence of diabetes by 14% relative to placebo. This “would translate into 38 fewer cases of diabetes per 1,000 patients treated for 5 years,” said Dr. Robert M. Califf of the Duke Translational Medicine Institute in Durham, N.C., and his NAVIGATOR colleagues.

It is possible that valsartan did not improve CV outcomes as it should have because most risk factors were already well controlled, since study subjects were allowed to take nonstudy medications such as ACE inhibitors, they said (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMoa1001121]).

In his editorial comment, Dr. Nathan agreed that “the high rates of loss to follow-up (13%), use of off-study ACE inhibitors or ARBs among participants assigned to placebo (24%), and nonadherence to valsartan (34% by study end) could explain the absence of an effect on cardiovascular disease.”

Overall, the NAVIGATOR results “do not support the contention that reducing postprandial hyperglycemia has a specific role in preventing diabetes or reducing cardiovascular disease. Other than increasing the rate of hypoglycemia by a factor of two, nateglinide had little effect,” Dr. Nathan commented.

The study was sponsored and designed by Novartis Pharma, manufacturer of both drugs. Novartis also collected, managed, and analyzed the data. In addition to support from Novartis, the NAVIGATOR researchers reported receiving financial support from Sanofi-Aventis and Merck. Dr. Nathan reported no financial conflicts of interest.

My Take

RAS Inhibition, Lifestyle Modification Affirmed

The NAVIGATOR trial was an ambitious effort to assess the ability of nateglinide and valsartan to prevent the onset of diabetes and adverse cardiovascular outcomes. Given our growing diabetes epidemic, meaningfully positive findings for either outcome with either intervention would have been welcome.

Unfortunately, both treatments were disappointing with regard to each of the co-primary end points. Furthermore, nateglinide was also linked to greater weight gain and increase in waist circumference, likely foreboding a higher rate of future diabetes.

Although valsartan did not prevent CV events or any of its other component events, it was associated with a significantly lower incidence of new onset diabetes, compared with placebo.

Similar reductions have been noted with other inhibitors of the renin-angiotensin system, but these are far less impressive than those seen with successful life-style modifications or metformin, which reduced the onset of type II diabetes in similar patients in the Diabetes Prevention Program by 58% and 31%, respectively (N. Engl. J. Med. 2002;346:393-403).

It now appears that the goal of diabetes prevention is best addressed by changing behavior, and with the hope that improvements in cardiovascular (CV) outcomes will follow.

Until then, it seems reasonable to use an inhibitor of the RAS system as part of the antihypertensive regimen that most prediabetic and diabetic patients will need.

DR. BARRY MASSIE is professor of medicine at the University of California, San Francisco, and chief of cardiology at the San Francisco Veterans Affairs Medical Center. He has financial relationships with Novartis, Merck, and Cytokinetics, among other pharmaceutical companies.

Immunizing children aged 3–15 years in isolated rural communities against influenza conferred substantial immunity to unvaccinated members of the communities, according to a report.

“Our findings offer experimental proof to support selective influenza immunization of school-aged children with inactivated influenza vaccine to interrupt influenza transmission. Particularly, if there are constraints in quantity and delivery of vaccine, it may be advantageous to selectively immunize children in order to reduce community transmission of influenza,” said Dr. Mark Loeb of McMaster University, Hamilton, Ont., and his associates.

Observational and computer modeling studies have suggested that such an approach might reduce influenza transmission, but randomized clinical trials to confirm this theory have not been feasible because in most settings, it would be unethical to withhold immunization from children in a control group.

However, rural Hutterite colonies in Western Canada offer a unique setting for such a study. These communities of approximately 60–120 Anabaptist residents are relatively isolated from other populations but show significant influenza activity each winter. The members of 46 Hutterite colonies in Alberta, Saskatchewan, and Manitoba agreed to random assignment to receive either immunization for influenza A and B during the 2008–2009 flu season (22 colonies) or to receive hepatitis A vaccination as a control (24 colonies).

Only healthy children aged 3–15 years were immunized, because those are the ages at which Hutterite children attend school. Mean vaccine coverage was 83% in this age group. This resulted in 502 children receiving flu vaccine in a population totaling 1,773 and 445 children receiving hepatitis A vaccine in a population totaling 1,500. Other colony members were not immunized, as is customary in Hutterite colonies. This includes community members at high risk of influenza complications such as children aged 23 months and younger, pregnant women, the elderly, and people of all ages with chronic medical conditions.

The primary outcome of this study was the development of laboratory-confirmed influenza A or B in colony members who did not receive flu vaccine. This occurred in 39 members of colonies assigned to influenza immunization (3%), a rate less than half of the 7.6% rate of influenza infection in control colonies.

“The level of indirect vaccine protectiveness was 61%” overall and 49% among high-risk subjects, Dr. Loeb and his colleagues said (JAMA 2010;303:943–50).

Disclosures: This study was supported by the Canadian Institutes for Health Research and the National Institute for Allergy and Infectious Diseases. Sanofi Pasteur donated vaccines used for the study but provided no funding and had no other role in the study. The authors said they had no conflicts of interest.

Immunizing children aged 3–15 years in isolated rural communities against influenza conferred substantial immunity to unvaccinated members of the communities, according to a report.

“Our findings offer experimental proof to support selective influenza immunization of school-aged children with inactivated influenza vaccine to interrupt influenza transmission. Particularly, if there are constraints in quantity and delivery of vaccine, it may be advantageous to selectively immunize children in order to reduce community transmission of influenza,” said Dr. Mark Loeb of McMaster University, Hamilton, Ont., and his associates.

Observational and computer modeling studies have suggested that such an approach might reduce influenza transmission, but randomized clinical trials to confirm this theory have not been feasible because in most settings, it would be unethical to withhold immunization from children in a control group.

However, rural Hutterite colonies in Western Canada offer a unique setting for such a study. These communities of approximately 60–120 Anabaptist residents are relatively isolated from other populations but show significant influenza activity each winter. The members of 46 Hutterite colonies in Alberta, Saskatchewan, and Manitoba agreed to random assignment to receive either immunization for influenza A and B during the 2008–2009 flu season (22 colonies) or to receive hepatitis A vaccination as a control (24 colonies).

Only healthy children aged 3–15 years were immunized, because those are the ages at which Hutterite children attend school. Mean vaccine coverage was 83% in this age group. This resulted in 502 children receiving flu vaccine in a population totaling 1,773 and 445 children receiving hepatitis A vaccine in a population totaling 1,500. Other colony members were not immunized, as is customary in Hutterite colonies. This includes community members at high risk of influenza complications such as children aged 23 months and younger, pregnant women, the elderly, and people of all ages with chronic medical conditions.

The primary outcome of this study was the development of laboratory-confirmed influenza A or B in colony members who did not receive flu vaccine. This occurred in 39 members of colonies assigned to influenza immunization (3%), a rate less than half of the 7.6% rate of influenza infection in control colonies.

“The level of indirect vaccine protectiveness was 61%” overall and 49% among high-risk subjects, Dr. Loeb and his colleagues said (JAMA 2010;303:943–50).

Disclosures: This study was supported by the Canadian Institutes for Health Research and the National Institute for Allergy and Infectious Diseases. Sanofi Pasteur donated vaccines used for the study but provided no funding and had no other role in the study. The authors said they had no conflicts of interest.

Immunizing children aged 3–15 years in isolated rural communities against influenza conferred substantial immunity to unvaccinated members of the communities, according to a report.

“Our findings offer experimental proof to support selective influenza immunization of school-aged children with inactivated influenza vaccine to interrupt influenza transmission. Particularly, if there are constraints in quantity and delivery of vaccine, it may be advantageous to selectively immunize children in order to reduce community transmission of influenza,” said Dr. Mark Loeb of McMaster University, Hamilton, Ont., and his associates.

Observational and computer modeling studies have suggested that such an approach might reduce influenza transmission, but randomized clinical trials to confirm this theory have not been feasible because in most settings, it would be unethical to withhold immunization from children in a control group.

However, rural Hutterite colonies in Western Canada offer a unique setting for such a study. These communities of approximately 60–120 Anabaptist residents are relatively isolated from other populations but show significant influenza activity each winter. The members of 46 Hutterite colonies in Alberta, Saskatchewan, and Manitoba agreed to random assignment to receive either immunization for influenza A and B during the 2008–2009 flu season (22 colonies) or to receive hepatitis A vaccination as a control (24 colonies).

Only healthy children aged 3–15 years were immunized, because those are the ages at which Hutterite children attend school. Mean vaccine coverage was 83% in this age group. This resulted in 502 children receiving flu vaccine in a population totaling 1,773 and 445 children receiving hepatitis A vaccine in a population totaling 1,500. Other colony members were not immunized, as is customary in Hutterite colonies. This includes community members at high risk of influenza complications such as children aged 23 months and younger, pregnant women, the elderly, and people of all ages with chronic medical conditions.

The primary outcome of this study was the development of laboratory-confirmed influenza A or B in colony members who did not receive flu vaccine. This occurred in 39 members of colonies assigned to influenza immunization (3%), a rate less than half of the 7.6% rate of influenza infection in control colonies.

“The level of indirect vaccine protectiveness was 61%” overall and 49% among high-risk subjects, Dr. Loeb and his colleagues said (JAMA 2010;303:943–50).

Disclosures: This study was supported by the Canadian Institutes for Health Research and the National Institute for Allergy and Infectious Diseases. Sanofi Pasteur donated vaccines used for the study but provided no funding and had no other role in the study. The authors said they had no conflicts of interest.