John R. Bell

Lidocaine drops for analgesia in children and teens with acute otitis media provided better pain relief than did a placebo for most patients, according to results of the first published trial.

Dr. Penny Bolt and her colleagues at the University of Melbourne's emergency department (ED) conducted a randomized, double-blind trial of patients with acute otitis media with no evidence of perforation.

The authors randomly assigned 31 patients to aqueous lidocaine 2% and 32 to a saline placebo.

All participants were offered a 15 mg/kg dose of acetaminophen if they had not taken an oral analgesic 4 hours before presenting to the ED.

Each patient's pain was assessed at baseline and at 10, 20, and 30 minutes, using a face pain scale for patients younger than 7 years and the visual analog scale for those aged 7-17 years.

The mean patient age in each group was approximately 6 years (range from 3 to 17 years). Patients were followed up at 1 day and 1 week post treatment and were given ear drops to use at home if needed (Arch. Dis. Child 2008;93;40-4[doi:10.1136/adc.2006.110429

In the ED, significantly more patients reported that their pain had been reduced by at least 50% at 10 minutes post treatment in the lidocaine group than in the placebo group (52% and 25%, respectively; relative risk 2.06).

The same was true at 30 minutes post treatment (90% vs. 63%; RR 2.04); the difference at 20 minutes was not statistically significant. The same trend was seen in the portion of patients in each group who reported a 25% pain reduction, with a significant relative risk in favor of lidocaine at all three time points.

There were no adverse events during the study period in the ED and no serious side effects within 1 week of treatment.

Five patients reported ear discharge 1-3 days post treatment, resolving within 1 week: two (7%) were in the lidocaine group and three (10%) in the placebo group.

Dr. Bolt and her colleagues noted that they did not control for concurrent analgesic use before baseline, but the portion of patients who had taken such medication was similar in the lidocaine and placebo groups (77% and 75%). They acknowledged that oral analgesia was a “likely contributor” to the pain relief in the study population.

The investigators noted that previous studies have shown that aqueous lidocaine does not penetrate noninflamed squamous epithelium, including that of the external tympanic membrane.

Greater drug uptake via inflamed epithelium, such as that concomitant with otitis media, may explain why the treatment was effective in these patients.

The use of lidocaine drops for acute otitis media is recommended in the clinical practice guidelines of the authors' institution, they said.

Dr. Bolt and her associates reported no conflicts of interest.

ELSEVIER GLOBAL MEDICAL NEWS

Lidocaine drops for analgesia in children and teens with acute otitis media provided better pain relief than did a placebo for most patients, according to results of the first published trial.

Dr. Penny Bolt and her colleagues at the University of Melbourne's emergency department (ED) conducted a randomized, double-blind trial of patients with acute otitis media with no evidence of perforation.

The authors randomly assigned 31 patients to aqueous lidocaine 2% and 32 to a saline placebo.

All participants were offered a 15 mg/kg dose of acetaminophen if they had not taken an oral analgesic 4 hours before presenting to the ED.

Each patient's pain was assessed at baseline and at 10, 20, and 30 minutes, using a face pain scale for patients younger than 7 years and the visual analog scale for those aged 7-17 years.

The mean patient age in each group was approximately 6 years (range from 3 to 17 years). Patients were followed up at 1 day and 1 week post treatment and were given ear drops to use at home if needed (Arch. Dis. Child 2008;93;40-4[doi:10.1136/adc.2006.110429

In the ED, significantly more patients reported that their pain had been reduced by at least 50% at 10 minutes post treatment in the lidocaine group than in the placebo group (52% and 25%, respectively; relative risk 2.06).

The same was true at 30 minutes post treatment (90% vs. 63%; RR 2.04); the difference at 20 minutes was not statistically significant. The same trend was seen in the portion of patients in each group who reported a 25% pain reduction, with a significant relative risk in favor of lidocaine at all three time points.

There were no adverse events during the study period in the ED and no serious side effects within 1 week of treatment.

Five patients reported ear discharge 1-3 days post treatment, resolving within 1 week: two (7%) were in the lidocaine group and three (10%) in the placebo group.

Dr. Bolt and her colleagues noted that they did not control for concurrent analgesic use before baseline, but the portion of patients who had taken such medication was similar in the lidocaine and placebo groups (77% and 75%). They acknowledged that oral analgesia was a “likely contributor” to the pain relief in the study population.

The investigators noted that previous studies have shown that aqueous lidocaine does not penetrate noninflamed squamous epithelium, including that of the external tympanic membrane.

Greater drug uptake via inflamed epithelium, such as that concomitant with otitis media, may explain why the treatment was effective in these patients.

The use of lidocaine drops for acute otitis media is recommended in the clinical practice guidelines of the authors' institution, they said.

Dr. Bolt and her associates reported no conflicts of interest.

ELSEVIER GLOBAL MEDICAL NEWS

Lidocaine drops for analgesia in children and teens with acute otitis media provided better pain relief than did a placebo for most patients, according to results of the first published trial.

Dr. Penny Bolt and her colleagues at the University of Melbourne's emergency department (ED) conducted a randomized, double-blind trial of patients with acute otitis media with no evidence of perforation.

The authors randomly assigned 31 patients to aqueous lidocaine 2% and 32 to a saline placebo.

All participants were offered a 15 mg/kg dose of acetaminophen if they had not taken an oral analgesic 4 hours before presenting to the ED.

Each patient's pain was assessed at baseline and at 10, 20, and 30 minutes, using a face pain scale for patients younger than 7 years and the visual analog scale for those aged 7-17 years.

The mean patient age in each group was approximately 6 years (range from 3 to 17 years). Patients were followed up at 1 day and 1 week post treatment and were given ear drops to use at home if needed (Arch. Dis. Child 2008;93;40-4[doi:10.1136/adc.2006.110429

In the ED, significantly more patients reported that their pain had been reduced by at least 50% at 10 minutes post treatment in the lidocaine group than in the placebo group (52% and 25%, respectively; relative risk 2.06).

The same was true at 30 minutes post treatment (90% vs. 63%; RR 2.04); the difference at 20 minutes was not statistically significant. The same trend was seen in the portion of patients in each group who reported a 25% pain reduction, with a significant relative risk in favor of lidocaine at all three time points.

There were no adverse events during the study period in the ED and no serious side effects within 1 week of treatment.

Five patients reported ear discharge 1-3 days post treatment, resolving within 1 week: two (7%) were in the lidocaine group and three (10%) in the placebo group.

Dr. Bolt and her colleagues noted that they did not control for concurrent analgesic use before baseline, but the portion of patients who had taken such medication was similar in the lidocaine and placebo groups (77% and 75%). They acknowledged that oral analgesia was a “likely contributor” to the pain relief in the study population.

The investigators noted that previous studies have shown that aqueous lidocaine does not penetrate noninflamed squamous epithelium, including that of the external tympanic membrane.

Greater drug uptake via inflamed epithelium, such as that concomitant with otitis media, may explain why the treatment was effective in these patients.

The use of lidocaine drops for acute otitis media is recommended in the clinical practice guidelines of the authors' institution, they said.

Dr. Bolt and her associates reported no conflicts of interest.

ELSEVIER GLOBAL MEDICAL NEWS

Patients with poorly controlled type 2 diabetes who for 1 year consumed a diet with a low glycemic index had reductions in their hemoglobin A_1c level similar to those seen with the diet recommended by the American Diabetes Association, according to research published in Nutrition.

Dr. Yusheng Ma of the University of Massachusetts, Worcester, and colleagues randomly assigned 40 individuals (age range 33–77 years; mean age 54 years) with type 2 diabetes and an HbA_1c of 7% or higher either to a diet based on the ADA recommendations (21) or to a diet that instead encouraged consumption of foods with a low glycemic index (19).

Participants received counseling monthly during the first 6 months and again at months 8 and 10, and completed a 7-day dietary recall at each visit.

In the ADA group, 52% of participants were men compared with 42% in the low-glycemic index (GI) group, though the difference was not statistically significant (Nutrition 2008;24:45–6).

Both mean HbA_1c level and total cholesterol level decreased over 12 months, with no significant difference between the two dietary groups.

Over the same period, HDL cholesterol increased in both groups. However, the mean LDL cholesterol level dropped from 89 mg/dL at baseline to 71 mg/dL at 12 months in the ADA group, while in the low-GI group, it rose, from 93 mg/dL at baseline to 95 mg/dL at 12 months.

Mean weight dropped in both groups, but mean waist circumference rose in both. Caloric intake in the ADA group was higher at 6 and 12 months while in the low-GI group it was lower at both time points.

Those participants in the low-GI group also were less likely to add or switch diabetes medications than were those in the ADA group (odds ratio 0.26), but this finding was also significantly associated with higher body mass index, high HbA_1c level, and male gender.

These results led the investigators to conclude that a low- glycemic index diet is equally able to reduce and control HbA_1c and blood lipids as the ADA-recommended diet, which entails carbohydrate counting without regard to glycemic index.

They acknowledged several limitations of the study, including lower attendance at counseling sessions among the low-GI group, and they cautioned that the findings warrant replication in a larger randomized controlled trial.

Patients with poorly controlled type 2 diabetes who for 1 year consumed a diet with a low glycemic index had reductions in their hemoglobin A_1c level similar to those seen with the diet recommended by the American Diabetes Association, according to research published in Nutrition.

Dr. Yusheng Ma of the University of Massachusetts, Worcester, and colleagues randomly assigned 40 individuals (age range 33–77 years; mean age 54 years) with type 2 diabetes and an HbA_1c of 7% or higher either to a diet based on the ADA recommendations (21) or to a diet that instead encouraged consumption of foods with a low glycemic index (19).

Participants received counseling monthly during the first 6 months and again at months 8 and 10, and completed a 7-day dietary recall at each visit.

In the ADA group, 52% of participants were men compared with 42% in the low-glycemic index (GI) group, though the difference was not statistically significant (Nutrition 2008;24:45–6).

Both mean HbA_1c level and total cholesterol level decreased over 12 months, with no significant difference between the two dietary groups.

Over the same period, HDL cholesterol increased in both groups. However, the mean LDL cholesterol level dropped from 89 mg/dL at baseline to 71 mg/dL at 12 months in the ADA group, while in the low-GI group, it rose, from 93 mg/dL at baseline to 95 mg/dL at 12 months.

Mean weight dropped in both groups, but mean waist circumference rose in both. Caloric intake in the ADA group was higher at 6 and 12 months while in the low-GI group it was lower at both time points.

Those participants in the low-GI group also were less likely to add or switch diabetes medications than were those in the ADA group (odds ratio 0.26), but this finding was also significantly associated with higher body mass index, high HbA_1c level, and male gender.

These results led the investigators to conclude that a low- glycemic index diet is equally able to reduce and control HbA_1c and blood lipids as the ADA-recommended diet, which entails carbohydrate counting without regard to glycemic index.

They acknowledged several limitations of the study, including lower attendance at counseling sessions among the low-GI group, and they cautioned that the findings warrant replication in a larger randomized controlled trial.

Patients with poorly controlled type 2 diabetes who for 1 year consumed a diet with a low glycemic index had reductions in their hemoglobin A_1c level similar to those seen with the diet recommended by the American Diabetes Association, according to research published in Nutrition.

Dr. Yusheng Ma of the University of Massachusetts, Worcester, and colleagues randomly assigned 40 individuals (age range 33–77 years; mean age 54 years) with type 2 diabetes and an HbA_1c of 7% or higher either to a diet based on the ADA recommendations (21) or to a diet that instead encouraged consumption of foods with a low glycemic index (19).

Participants received counseling monthly during the first 6 months and again at months 8 and 10, and completed a 7-day dietary recall at each visit.

In the ADA group, 52% of participants were men compared with 42% in the low-glycemic index (GI) group, though the difference was not statistically significant (Nutrition 2008;24:45–6).

Both mean HbA_1c level and total cholesterol level decreased over 12 months, with no significant difference between the two dietary groups.

Over the same period, HDL cholesterol increased in both groups. However, the mean LDL cholesterol level dropped from 89 mg/dL at baseline to 71 mg/dL at 12 months in the ADA group, while in the low-GI group, it rose, from 93 mg/dL at baseline to 95 mg/dL at 12 months.

Mean weight dropped in both groups, but mean waist circumference rose in both. Caloric intake in the ADA group was higher at 6 and 12 months while in the low-GI group it was lower at both time points.

Those participants in the low-GI group also were less likely to add or switch diabetes medications than were those in the ADA group (odds ratio 0.26), but this finding was also significantly associated with higher body mass index, high HbA_1c level, and male gender.

These results led the investigators to conclude that a low- glycemic index diet is equally able to reduce and control HbA_1c and blood lipids as the ADA-recommended diet, which entails carbohydrate counting without regard to glycemic index.

They acknowledged several limitations of the study, including lower attendance at counseling sessions among the low-GI group, and they cautioned that the findings warrant replication in a larger randomized controlled trial.

Moderate-intensity exercise that was equivalent to walking about 12 miles over an average of 170 minutes per week significantly improved features of the metabolic syndrome even without dietary modification in a study of 171 overweight adults.

Johanna L. Johnson of Duke University, Durham, N.C., and colleagues analyzed 171 overweight or mildly obese participants (80 men and 91 women) previously enrolled in the Studies of a Targeted Risk Reduction Intervention Through Defined Exercise trial. They reported their findings in the American Journal of Cardiology.

Each person was randomly assigned to 6 months of continued inactivity or one of three 6-month exercise regimens: low amount/moderate intensity (calorically equivalent to walking 12 miles a week at 40%–55% peak oxygen consumption), low amount/vigorous intensity (equal to walking 12 miles a week at 65%–80% peak oxygen consumption), and high amount/vigorous intensity (equal to walking 20 miles a week at 65%–80% peak oxygen consumption). All participants were instructed to continue their usual diet (Am. J. Cardiol. 2007; 100[12]:1759–66).

To define metabolic syndrome, the investigators used the Education Program Adult Treatment Panel III (ATP III) criteria, in which metabolic syndrome is indicated by the presence of at least three of the following risk factors: increased waist circumference (at least 102 cm in men and 88 cm in women), increased triglyceride level (at least 150 mg/dL), decreased HDL cholesterol level (less than 40 mg/dL in men or 50 mg/dL in women), increased blood pressure (at least 130 mm Hg systolic or at least 85 mm Hg diastolic), and increased fasting glucose level (100 mg/dL or higher). The authors also devised a continuous z score of all five metabolic syndrome variables to more accurately reflect overall metabolic changes.

Participants were aged 40–65 years and were overweight or mildly obese (body mass index of 25–35 kg/m

After 6 months, improvements were seen in many metabolic syndrome parameters among both exercise groups, compared with controls.

For example, mean waist circumference dropped by 1.1 cm among all patients in the low/moderate and low/vigorous groups and by 2.6 cm for the high/vigorous group, but rose by 0.6 cm among controls. Likewise, the z score for the control group did not change over the 6 months, but it fell by 0.8 in the low/moderate group, 0.3 in the low/vigorous group, and 1.4 in the high/vigorous group.

A surprising finding, the authors noted, was that although a low amount of moderate-intensity exercise showed a significant improvement in both z score and total ATP III score at 6 months, a low amount of exercise with high intensity actually showed no significant improvement over the sedentary controls. They theorized that this may be because lower-intensity exercise relies more on fat oxidation, whereas higher-intensity exercise entails more carbohydrate oxidation.

“Our findings clearly indicate that a modest amount of moderate-intensity exercise is adequate for obtaining significant health benefits,” Ms. Johnson and her colleagues wrote. “This is an exercise prescription likely to be perceived by the general public and clinicians alike as an obtainable goal.”

ELSEVIER GLOBAL MEDICAL NEWS

Moderate-intensity exercise that was equivalent to walking about 12 miles over an average of 170 minutes per week significantly improved features of the metabolic syndrome even without dietary modification in a study of 171 overweight adults.

Johanna L. Johnson of Duke University, Durham, N.C., and colleagues analyzed 171 overweight or mildly obese participants (80 men and 91 women) previously enrolled in the Studies of a Targeted Risk Reduction Intervention Through Defined Exercise trial. They reported their findings in the American Journal of Cardiology.

Each person was randomly assigned to 6 months of continued inactivity or one of three 6-month exercise regimens: low amount/moderate intensity (calorically equivalent to walking 12 miles a week at 40%–55% peak oxygen consumption), low amount/vigorous intensity (equal to walking 12 miles a week at 65%–80% peak oxygen consumption), and high amount/vigorous intensity (equal to walking 20 miles a week at 65%–80% peak oxygen consumption). All participants were instructed to continue their usual diet (Am. J. Cardiol. 2007; 100[12]:1759–66).

To define metabolic syndrome, the investigators used the Education Program Adult Treatment Panel III (ATP III) criteria, in which metabolic syndrome is indicated by the presence of at least three of the following risk factors: increased waist circumference (at least 102 cm in men and 88 cm in women), increased triglyceride level (at least 150 mg/dL), decreased HDL cholesterol level (less than 40 mg/dL in men or 50 mg/dL in women), increased blood pressure (at least 130 mm Hg systolic or at least 85 mm Hg diastolic), and increased fasting glucose level (100 mg/dL or higher). The authors also devised a continuous z score of all five metabolic syndrome variables to more accurately reflect overall metabolic changes.

Participants were aged 40–65 years and were overweight or mildly obese (body mass index of 25–35 kg/m

After 6 months, improvements were seen in many metabolic syndrome parameters among both exercise groups, compared with controls.

For example, mean waist circumference dropped by 1.1 cm among all patients in the low/moderate and low/vigorous groups and by 2.6 cm for the high/vigorous group, but rose by 0.6 cm among controls. Likewise, the z score for the control group did not change over the 6 months, but it fell by 0.8 in the low/moderate group, 0.3 in the low/vigorous group, and 1.4 in the high/vigorous group.

A surprising finding, the authors noted, was that although a low amount of moderate-intensity exercise showed a significant improvement in both z score and total ATP III score at 6 months, a low amount of exercise with high intensity actually showed no significant improvement over the sedentary controls. They theorized that this may be because lower-intensity exercise relies more on fat oxidation, whereas higher-intensity exercise entails more carbohydrate oxidation.

“Our findings clearly indicate that a modest amount of moderate-intensity exercise is adequate for obtaining significant health benefits,” Ms. Johnson and her colleagues wrote. “This is an exercise prescription likely to be perceived by the general public and clinicians alike as an obtainable goal.”

ELSEVIER GLOBAL MEDICAL NEWS

Moderate-intensity exercise that was equivalent to walking about 12 miles over an average of 170 minutes per week significantly improved features of the metabolic syndrome even without dietary modification in a study of 171 overweight adults.

Johanna L. Johnson of Duke University, Durham, N.C., and colleagues analyzed 171 overweight or mildly obese participants (80 men and 91 women) previously enrolled in the Studies of a Targeted Risk Reduction Intervention Through Defined Exercise trial. They reported their findings in the American Journal of Cardiology.

Each person was randomly assigned to 6 months of continued inactivity or one of three 6-month exercise regimens: low amount/moderate intensity (calorically equivalent to walking 12 miles a week at 40%–55% peak oxygen consumption), low amount/vigorous intensity (equal to walking 12 miles a week at 65%–80% peak oxygen consumption), and high amount/vigorous intensity (equal to walking 20 miles a week at 65%–80% peak oxygen consumption). All participants were instructed to continue their usual diet (Am. J. Cardiol. 2007; 100[12]:1759–66).

To define metabolic syndrome, the investigators used the Education Program Adult Treatment Panel III (ATP III) criteria, in which metabolic syndrome is indicated by the presence of at least three of the following risk factors: increased waist circumference (at least 102 cm in men and 88 cm in women), increased triglyceride level (at least 150 mg/dL), decreased HDL cholesterol level (less than 40 mg/dL in men or 50 mg/dL in women), increased blood pressure (at least 130 mm Hg systolic or at least 85 mm Hg diastolic), and increased fasting glucose level (100 mg/dL or higher). The authors also devised a continuous z score of all five metabolic syndrome variables to more accurately reflect overall metabolic changes.

Participants were aged 40–65 years and were overweight or mildly obese (body mass index of 25–35 kg/m

After 6 months, improvements were seen in many metabolic syndrome parameters among both exercise groups, compared with controls.

For example, mean waist circumference dropped by 1.1 cm among all patients in the low/moderate and low/vigorous groups and by 2.6 cm for the high/vigorous group, but rose by 0.6 cm among controls. Likewise, the z score for the control group did not change over the 6 months, but it fell by 0.8 in the low/moderate group, 0.3 in the low/vigorous group, and 1.4 in the high/vigorous group.

A surprising finding, the authors noted, was that although a low amount of moderate-intensity exercise showed a significant improvement in both z score and total ATP III score at 6 months, a low amount of exercise with high intensity actually showed no significant improvement over the sedentary controls. They theorized that this may be because lower-intensity exercise relies more on fat oxidation, whereas higher-intensity exercise entails more carbohydrate oxidation.

“Our findings clearly indicate that a modest amount of moderate-intensity exercise is adequate for obtaining significant health benefits,” Ms. Johnson and her colleagues wrote. “This is an exercise prescription likely to be perceived by the general public and clinicians alike as an obtainable goal.”

ELSEVIER GLOBAL MEDICAL NEWS

The American College of Physicians has for the first time called for legally mandated universal coverage for all U.S. residents and has urged lawmakers to consider a single-payer system as one option for achieving that goal.

In a lengthy analysis and health care reform proposal, the ACP also recommends greater use of cost-control incentives directed at patients, perhaps including greater sharing of costs and more use of health care savings accounts.

The report also recommends a uniform billing system for all services, more primary care training programs, federal support for the medical home model, pay for performance, a universal information technology infrastructure, and greater investment in medical research (Ann. Intern. Med. 2008;148:55–75).

Robert Doherty, the ACP's senior vice president for governmental affairs and public policy, and one of the authors of the report, said that the ACP will not pursue specific legislation in the coming year aimed at implementing the recommendations, but hopes to bring health care reform to the forefront of the presidential and congressional elections. However, the college supports provisions in the pending Medicare/State Children's Health Insurance Program (SCHIP) bill that would require Medicare to pay physicians in up to 500 practices around the country for coordinating care through a medical home.

David Karlson, Ph.D., executive director of the Society of General Internal Medicine, said that his organization is in "broad agreement" with the principles outlined by the ACP. "Many SGIM members have been even more favorably disposed to simplified (e.g., single-payer) approaches to health insurance financing, and place an even greater emphasis on physicians avoiding conflicted relationships with industry," he said in an interview.

In advocating for universal coverage, the authors of the report compared the U.S. system with the systems of selected other countries, including those with a single-payer system of universal coverage (Canada, Japan, Taiwan, and the United Kingdom) and those with a "pluralistic" system, in which private and public institutions fund the costs of care for all residents (Australia and New Zealand) and coverage is guaranteed regardless of ability to pay.

Single-payer systems, the report said, are generally more equitable, have lower administrative costs, and have lower per capita health care expenditures than do systems using private health insurance. Single-payer systems also have high levels of patient satisfaction and high performance on measures of quality and access. However, shortages of services as a result of price controls are a risk.

A pluralistic system of universal coverage would "ensure universal access while allowing individuals the freedom to purchase private supplemental coverage. The disadvantages of this system are that it is likely to result in inequalities in coverage and higher administrative costs," according to the report.

Dr. Arnold S. Relman, former editor of the New England Journal of Medicine, said that he found the ACP's recommendations "very disappointing." In his view, a pluralistic system in which nonprofit and for-profit institutions fund care via insurance is essentially no different from the current system. Moreover, the idea that there could be legally guaranteed coverage in such a system is "totally unrealistic," said Dr. Relman, professor emeritus of medicine and of social medicine at Harvard Medical School, Boston.

Dr. James King, president of the American Academy of Family Physicians, said that although insurance company profits share some of the blame for increasing costs, the cost of increasing technology and duplicated procedures (which could be prevented by electronic health records) also are factors.

The AAFP also has issued health care reform recommendations (available at www.aafp.org

In its report, the ACP called for "incentives to encourage patients to be prudent purchasers and to participate in their health care." These incentives could include increased use of "cost sharing," in which patients are required to pay more out-of-pocket costs, as well as more use of health care savings accounts, but should be designed to not deter patients from getting needed care, the report said.

This goal of cost sharing is "a favorite of all the conservative think tanks… but it ain't going to work." Dr. Relman said. "When you're sick, you don't shop around. There are no consumers in the emergency room or in the intensive care unit."

Dr. David Dale, president of the ACP, agreed in an interview that there are times when an acutely ill patient necessarily has a passive role in choosing health care. But the recommendation for greater patient involvement is especially relevant in the context of chronic care, said Dr. Dale, also professor of medicine at the University of Washington, Seattle.

In any case, there is near unanimity that health care costs are out of control. Dr. Harold Sox, editor of the Annals of Internal Medicine, wrote in an editorial accompanying the report, "The country seems headed for an unprecedented fiscal crisis if it can't control the costs of health care" (Ann. Intern. Med. 2008;148:78–9). He noted that although health care reform is a frequent topic in the nascent presidential election season, the same was true in 1992, and major reforms did not arrive.

The American Academy of Dermatology has not taken a position on this issue, according to an AAD representative.

The American College of Physicians has for the first time called for legally mandated universal coverage for all U.S. residents and has urged lawmakers to consider a single-payer system as one option for achieving that goal.

In a lengthy analysis and health care reform proposal, the ACP also recommends greater use of cost-control incentives directed at patients, perhaps including greater sharing of costs and more use of health care savings accounts.

The report also recommends a uniform billing system for all services, more primary care training programs, federal support for the medical home model, pay for performance, a universal information technology infrastructure, and greater investment in medical research (Ann. Intern. Med. 2008;148:55–75).

Robert Doherty, the ACP's senior vice president for governmental affairs and public policy, and one of the authors of the report, said that the ACP will not pursue specific legislation in the coming year aimed at implementing the recommendations, but hopes to bring health care reform to the forefront of the presidential and congressional elections. However, the college supports provisions in the pending Medicare/State Children's Health Insurance Program (SCHIP) bill that would require Medicare to pay physicians in up to 500 practices around the country for coordinating care through a medical home.

David Karlson, Ph.D., executive director of the Society of General Internal Medicine, said that his organization is in "broad agreement" with the principles outlined by the ACP. "Many SGIM members have been even more favorably disposed to simplified (e.g., single-payer) approaches to health insurance financing, and place an even greater emphasis on physicians avoiding conflicted relationships with industry," he said in an interview.

In advocating for universal coverage, the authors of the report compared the U.S. system with the systems of selected other countries, including those with a single-payer system of universal coverage (Canada, Japan, Taiwan, and the United Kingdom) and those with a "pluralistic" system, in which private and public institutions fund the costs of care for all residents (Australia and New Zealand) and coverage is guaranteed regardless of ability to pay.

Single-payer systems, the report said, are generally more equitable, have lower administrative costs, and have lower per capita health care expenditures than do systems using private health insurance. Single-payer systems also have high levels of patient satisfaction and high performance on measures of quality and access. However, shortages of services as a result of price controls are a risk.

A pluralistic system of universal coverage would "ensure universal access while allowing individuals the freedom to purchase private supplemental coverage. The disadvantages of this system are that it is likely to result in inequalities in coverage and higher administrative costs," according to the report.

Dr. Arnold S. Relman, former editor of the New England Journal of Medicine, said that he found the ACP's recommendations "very disappointing." In his view, a pluralistic system in which nonprofit and for-profit institutions fund care via insurance is essentially no different from the current system. Moreover, the idea that there could be legally guaranteed coverage in such a system is "totally unrealistic," said Dr. Relman, professor emeritus of medicine and of social medicine at Harvard Medical School, Boston.

Dr. James King, president of the American Academy of Family Physicians, said that although insurance company profits share some of the blame for increasing costs, the cost of increasing technology and duplicated procedures (which could be prevented by electronic health records) also are factors.

The AAFP also has issued health care reform recommendations (available at www.aafp.org

In its report, the ACP called for "incentives to encourage patients to be prudent purchasers and to participate in their health care." These incentives could include increased use of "cost sharing," in which patients are required to pay more out-of-pocket costs, as well as more use of health care savings accounts, but should be designed to not deter patients from getting needed care, the report said.

This goal of cost sharing is "a favorite of all the conservative think tanks… but it ain't going to work." Dr. Relman said. "When you're sick, you don't shop around. There are no consumers in the emergency room or in the intensive care unit."

Dr. David Dale, president of the ACP, agreed in an interview that there are times when an acutely ill patient necessarily has a passive role in choosing health care. But the recommendation for greater patient involvement is especially relevant in the context of chronic care, said Dr. Dale, also professor of medicine at the University of Washington, Seattle.

In any case, there is near unanimity that health care costs are out of control. Dr. Harold Sox, editor of the Annals of Internal Medicine, wrote in an editorial accompanying the report, "The country seems headed for an unprecedented fiscal crisis if it can't control the costs of health care" (Ann. Intern. Med. 2008;148:78–9). He noted that although health care reform is a frequent topic in the nascent presidential election season, the same was true in 1992, and major reforms did not arrive.

The American Academy of Dermatology has not taken a position on this issue, according to an AAD representative.

The American College of Physicians has for the first time called for legally mandated universal coverage for all U.S. residents and has urged lawmakers to consider a single-payer system as one option for achieving that goal.

In a lengthy analysis and health care reform proposal, the ACP also recommends greater use of cost-control incentives directed at patients, perhaps including greater sharing of costs and more use of health care savings accounts.

The report also recommends a uniform billing system for all services, more primary care training programs, federal support for the medical home model, pay for performance, a universal information technology infrastructure, and greater investment in medical research (Ann. Intern. Med. 2008;148:55–75).

Robert Doherty, the ACP's senior vice president for governmental affairs and public policy, and one of the authors of the report, said that the ACP will not pursue specific legislation in the coming year aimed at implementing the recommendations, but hopes to bring health care reform to the forefront of the presidential and congressional elections. However, the college supports provisions in the pending Medicare/State Children's Health Insurance Program (SCHIP) bill that would require Medicare to pay physicians in up to 500 practices around the country for coordinating care through a medical home.

David Karlson, Ph.D., executive director of the Society of General Internal Medicine, said that his organization is in "broad agreement" with the principles outlined by the ACP. "Many SGIM members have been even more favorably disposed to simplified (e.g., single-payer) approaches to health insurance financing, and place an even greater emphasis on physicians avoiding conflicted relationships with industry," he said in an interview.

In advocating for universal coverage, the authors of the report compared the U.S. system with the systems of selected other countries, including those with a single-payer system of universal coverage (Canada, Japan, Taiwan, and the United Kingdom) and those with a "pluralistic" system, in which private and public institutions fund the costs of care for all residents (Australia and New Zealand) and coverage is guaranteed regardless of ability to pay.

Single-payer systems, the report said, are generally more equitable, have lower administrative costs, and have lower per capita health care expenditures than do systems using private health insurance. Single-payer systems also have high levels of patient satisfaction and high performance on measures of quality and access. However, shortages of services as a result of price controls are a risk.

A pluralistic system of universal coverage would "ensure universal access while allowing individuals the freedom to purchase private supplemental coverage. The disadvantages of this system are that it is likely to result in inequalities in coverage and higher administrative costs," according to the report.

Dr. Arnold S. Relman, former editor of the New England Journal of Medicine, said that he found the ACP's recommendations "very disappointing." In his view, a pluralistic system in which nonprofit and for-profit institutions fund care via insurance is essentially no different from the current system. Moreover, the idea that there could be legally guaranteed coverage in such a system is "totally unrealistic," said Dr. Relman, professor emeritus of medicine and of social medicine at Harvard Medical School, Boston.

Dr. James King, president of the American Academy of Family Physicians, said that although insurance company profits share some of the blame for increasing costs, the cost of increasing technology and duplicated procedures (which could be prevented by electronic health records) also are factors.

The AAFP also has issued health care reform recommendations (available at www.aafp.org

In its report, the ACP called for "incentives to encourage patients to be prudent purchasers and to participate in their health care." These incentives could include increased use of "cost sharing," in which patients are required to pay more out-of-pocket costs, as well as more use of health care savings accounts, but should be designed to not deter patients from getting needed care, the report said.

This goal of cost sharing is "a favorite of all the conservative think tanks… but it ain't going to work." Dr. Relman said. "When you're sick, you don't shop around. There are no consumers in the emergency room or in the intensive care unit."

Dr. David Dale, president of the ACP, agreed in an interview that there are times when an acutely ill patient necessarily has a passive role in choosing health care. But the recommendation for greater patient involvement is especially relevant in the context of chronic care, said Dr. Dale, also professor of medicine at the University of Washington, Seattle.

In any case, there is near unanimity that health care costs are out of control. Dr. Harold Sox, editor of the Annals of Internal Medicine, wrote in an editorial accompanying the report, "The country seems headed for an unprecedented fiscal crisis if it can't control the costs of health care" (Ann. Intern. Med. 2008;148:78–9). He noted that although health care reform is a frequent topic in the nascent presidential election season, the same was true in 1992, and major reforms did not arrive.

The American Academy of Dermatology has not taken a position on this issue, according to an AAD representative.

Alcohol-dependent persons with cirrhosis of the liver who were treated with baclofen, a ?-aminobutyric acid-B receptor agonist, were more than six times as likely to cease their alcohol use as were patients who took a placebo, according to a study.

The trial is the first “in which effectiveness and safety of an anticraving drug has been investigated in individuals with advanced liver disease,” wrote Dr. Giovanni Addolorato of the Catholic University of Rome, and colleagues. They reported results for 84 alcohol-dependent patients with a diagnosis of cirrhosis who were randomly assigned in equal number to a 12-week regimen of either baclofen or placebo.

The baclofen dosage was 5 mg three times daily for the first 3 days and 10 mg three times daily thereafter. Mean patient age was 49 years in both groups. Patients were seen weekly for the first month, then every 2 weeks until the end of the study (Lancet 2007;370:1915-22).

At 12 weeks, 30 (71%) of the 42 patients in the baclofen group were abstinent from alcohol, compared with 12 (29%) of the 42 patients in the placebo group (odds ratio 6.3).

In addition, those given baclofen showed improvements in measures of liver function, including ALT, bilirubin, international normalized ratio, ?-glutamyltransferase, and albumin. The drug was also associated with a greater number of nondrinking days than was placebo (63 days vs. 31 days), as well as a lower rate of relapse to heavy drinking at 60 days (19% vs. 45%).

Treatment with baclofen also reduced alcohol cravings, as measured with the obsessive-compulsive drinking scale.

Baclofen was not associated with any hepatotoxicity. There were no incidents of encephalopathy or hyperammonemia and no serious events leading to discontinuation of the drug. Tolerability was reported as fair, with headache, tiredness, vertigo, and sleepiness reported in small numbers of patients in both groups.

These results “suggest that baclofen, because of its anticraving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease,” the researchers wrote. They cautioned that further studies are needed to establish optimal treatment duration and longer-term tolerance.

In a commentary accompanying the report, Dr. James C. Garbutt of the University of North Carolina at Chapel Hill, and Barbara Flannery, Ph.D., of RTI International, Baltimore, called the findings “surprisingly robust” and of potentially great clinical importance, given the routine exclusion of alcoholic patients with cirrhosis from trials of anticraving drugs because of the concern about hepatotoxicity (Lancet 2007;370:1884-5).

They also noted that the higher dropout rate in the placebo group (31%) versus the baclofen group (14%) is of interest, because it may have skewed the results in favor of baclofen, given that these were assumed to be because of relapse, and thus affected the primary end point.

The study authors declared no financial conflict of interest. The study was supported by the Italian Ministry for University, Scientific, and Technological Research, and by the European Research Advisory Board.

Alcohol-dependent persons with cirrhosis of the liver who were treated with baclofen, a ?-aminobutyric acid-B receptor agonist, were more than six times as likely to cease their alcohol use as were patients who took a placebo, according to a study.

The trial is the first “in which effectiveness and safety of an anticraving drug has been investigated in individuals with advanced liver disease,” wrote Dr. Giovanni Addolorato of the Catholic University of Rome, and colleagues. They reported results for 84 alcohol-dependent patients with a diagnosis of cirrhosis who were randomly assigned in equal number to a 12-week regimen of either baclofen or placebo.

The baclofen dosage was 5 mg three times daily for the first 3 days and 10 mg three times daily thereafter. Mean patient age was 49 years in both groups. Patients were seen weekly for the first month, then every 2 weeks until the end of the study (Lancet 2007;370:1915-22).

At 12 weeks, 30 (71%) of the 42 patients in the baclofen group were abstinent from alcohol, compared with 12 (29%) of the 42 patients in the placebo group (odds ratio 6.3).

In addition, those given baclofen showed improvements in measures of liver function, including ALT, bilirubin, international normalized ratio, ?-glutamyltransferase, and albumin. The drug was also associated with a greater number of nondrinking days than was placebo (63 days vs. 31 days), as well as a lower rate of relapse to heavy drinking at 60 days (19% vs. 45%).

Treatment with baclofen also reduced alcohol cravings, as measured with the obsessive-compulsive drinking scale.

Baclofen was not associated with any hepatotoxicity. There were no incidents of encephalopathy or hyperammonemia and no serious events leading to discontinuation of the drug. Tolerability was reported as fair, with headache, tiredness, vertigo, and sleepiness reported in small numbers of patients in both groups.

These results “suggest that baclofen, because of its anticraving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease,” the researchers wrote. They cautioned that further studies are needed to establish optimal treatment duration and longer-term tolerance.

In a commentary accompanying the report, Dr. James C. Garbutt of the University of North Carolina at Chapel Hill, and Barbara Flannery, Ph.D., of RTI International, Baltimore, called the findings “surprisingly robust” and of potentially great clinical importance, given the routine exclusion of alcoholic patients with cirrhosis from trials of anticraving drugs because of the concern about hepatotoxicity (Lancet 2007;370:1884-5).

They also noted that the higher dropout rate in the placebo group (31%) versus the baclofen group (14%) is of interest, because it may have skewed the results in favor of baclofen, given that these were assumed to be because of relapse, and thus affected the primary end point.

The study authors declared no financial conflict of interest. The study was supported by the Italian Ministry for University, Scientific, and Technological Research, and by the European Research Advisory Board.

Alcohol-dependent persons with cirrhosis of the liver who were treated with baclofen, a ?-aminobutyric acid-B receptor agonist, were more than six times as likely to cease their alcohol use as were patients who took a placebo, according to a study.

The trial is the first “in which effectiveness and safety of an anticraving drug has been investigated in individuals with advanced liver disease,” wrote Dr. Giovanni Addolorato of the Catholic University of Rome, and colleagues. They reported results for 84 alcohol-dependent patients with a diagnosis of cirrhosis who were randomly assigned in equal number to a 12-week regimen of either baclofen or placebo.

The baclofen dosage was 5 mg three times daily for the first 3 days and 10 mg three times daily thereafter. Mean patient age was 49 years in both groups. Patients were seen weekly for the first month, then every 2 weeks until the end of the study (Lancet 2007;370:1915-22).

At 12 weeks, 30 (71%) of the 42 patients in the baclofen group were abstinent from alcohol, compared with 12 (29%) of the 42 patients in the placebo group (odds ratio 6.3).

In addition, those given baclofen showed improvements in measures of liver function, including ALT, bilirubin, international normalized ratio, ?-glutamyltransferase, and albumin. The drug was also associated with a greater number of nondrinking days than was placebo (63 days vs. 31 days), as well as a lower rate of relapse to heavy drinking at 60 days (19% vs. 45%).

Treatment with baclofen also reduced alcohol cravings, as measured with the obsessive-compulsive drinking scale.

Baclofen was not associated with any hepatotoxicity. There were no incidents of encephalopathy or hyperammonemia and no serious events leading to discontinuation of the drug. Tolerability was reported as fair, with headache, tiredness, vertigo, and sleepiness reported in small numbers of patients in both groups.

These results “suggest that baclofen, because of its anticraving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease,” the researchers wrote. They cautioned that further studies are needed to establish optimal treatment duration and longer-term tolerance.

In a commentary accompanying the report, Dr. James C. Garbutt of the University of North Carolina at Chapel Hill, and Barbara Flannery, Ph.D., of RTI International, Baltimore, called the findings “surprisingly robust” and of potentially great clinical importance, given the routine exclusion of alcoholic patients with cirrhosis from trials of anticraving drugs because of the concern about hepatotoxicity (Lancet 2007;370:1884-5).

They also noted that the higher dropout rate in the placebo group (31%) versus the baclofen group (14%) is of interest, because it may have skewed the results in favor of baclofen, given that these were assumed to be because of relapse, and thus affected the primary end point.

The study authors declared no financial conflict of interest. The study was supported by the Italian Ministry for University, Scientific, and Technological Research, and by the European Research Advisory Board.

NEW YORK — Subungual melanomas are often difficult to diagnose and thus present in an advanced clinical stage with poor prognosis, Dr. Richard Scolyer said at the Fourth International Melanoma Congress.

A review of the Sydney Melanoma Unit's experience between 1951 and 2004 showed that 124 patients presented with subungual melanoma (64 men and 60 women). The median patient age was 59 years, and the most common site was the great toe (24%). Most melanomas were locally advanced, with median Breslow thickness of 3.2 mm. Sentinel lymph node biopsy was positive in 24% (7 of 29 patients).

Follow-up data were available for 9 of 11 patients with in situ melanoma. American Joint Committee on Cancer disease stage at diagnosis, which was known in 121 patients, was the most important survival factor. Eleven patients (9%) were stage 0 (melanoma in situ), 16 (13%) were stage I, 50 (40%) were stage II, 39 (31%) were stage III, and 5 (4%) were stage IV.

The most common presentation in this group of patients was a pigmented subungual lesion or a raised or polypoid nodule, but "in more than one-third of patients (35%), there was no visible pigmentation in the affected area," said Dr. Scolyer of the University of Sydney.

Biopsies can be challenging to pathologists, in part because the features of melanoma in situ and the radial growth phase of melanoma are subtle. The most common early sign is longitudinal melanonychia. Particular red flags in these pigmented bands are increasing width, irregular width, and irregular spacing under dermoscopy, as well as extensions onto the proximal lateral nail fold (Hutchinson's sign). Subungual hematoma is important in the differential diagnosis, he said.

Unlike other melanomas, subungual melanoma is not associated with exposure to UV light, given that the nail plate is a UV barrier. Thus, incidence is similar among different ethnic backgrounds and skin tones. However, because melanomas in general are rare in people with darker skin, subungual melanomas make up a greater portion of melanomas among such persons, Dr. Scolyer noted.

NEW YORK — Subungual melanomas are often difficult to diagnose and thus present in an advanced clinical stage with poor prognosis, Dr. Richard Scolyer said at the Fourth International Melanoma Congress.

A review of the Sydney Melanoma Unit's experience between 1951 and 2004 showed that 124 patients presented with subungual melanoma (64 men and 60 women). The median patient age was 59 years, and the most common site was the great toe (24%). Most melanomas were locally advanced, with median Breslow thickness of 3.2 mm. Sentinel lymph node biopsy was positive in 24% (7 of 29 patients).

Follow-up data were available for 9 of 11 patients with in situ melanoma. American Joint Committee on Cancer disease stage at diagnosis, which was known in 121 patients, was the most important survival factor. Eleven patients (9%) were stage 0 (melanoma in situ), 16 (13%) were stage I, 50 (40%) were stage II, 39 (31%) were stage III, and 5 (4%) were stage IV.

The most common presentation in this group of patients was a pigmented subungual lesion or a raised or polypoid nodule, but "in more than one-third of patients (35%), there was no visible pigmentation in the affected area," said Dr. Scolyer of the University of Sydney.

Biopsies can be challenging to pathologists, in part because the features of melanoma in situ and the radial growth phase of melanoma are subtle. The most common early sign is longitudinal melanonychia. Particular red flags in these pigmented bands are increasing width, irregular width, and irregular spacing under dermoscopy, as well as extensions onto the proximal lateral nail fold (Hutchinson's sign). Subungual hematoma is important in the differential diagnosis, he said.

Unlike other melanomas, subungual melanoma is not associated with exposure to UV light, given that the nail plate is a UV barrier. Thus, incidence is similar among different ethnic backgrounds and skin tones. However, because melanomas in general are rare in people with darker skin, subungual melanomas make up a greater portion of melanomas among such persons, Dr. Scolyer noted.

NEW YORK — Subungual melanomas are often difficult to diagnose and thus present in an advanced clinical stage with poor prognosis, Dr. Richard Scolyer said at the Fourth International Melanoma Congress.

A review of the Sydney Melanoma Unit's experience between 1951 and 2004 showed that 124 patients presented with subungual melanoma (64 men and 60 women). The median patient age was 59 years, and the most common site was the great toe (24%). Most melanomas were locally advanced, with median Breslow thickness of 3.2 mm. Sentinel lymph node biopsy was positive in 24% (7 of 29 patients).

Follow-up data were available for 9 of 11 patients with in situ melanoma. American Joint Committee on Cancer disease stage at diagnosis, which was known in 121 patients, was the most important survival factor. Eleven patients (9%) were stage 0 (melanoma in situ), 16 (13%) were stage I, 50 (40%) were stage II, 39 (31%) were stage III, and 5 (4%) were stage IV.

The most common presentation in this group of patients was a pigmented subungual lesion or a raised or polypoid nodule, but "in more than one-third of patients (35%), there was no visible pigmentation in the affected area," said Dr. Scolyer of the University of Sydney.

Biopsies can be challenging to pathologists, in part because the features of melanoma in situ and the radial growth phase of melanoma are subtle. The most common early sign is longitudinal melanonychia. Particular red flags in these pigmented bands are increasing width, irregular width, and irregular spacing under dermoscopy, as well as extensions onto the proximal lateral nail fold (Hutchinson's sign). Subungual hematoma is important in the differential diagnosis, he said.

Unlike other melanomas, subungual melanoma is not associated with exposure to UV light, given that the nail plate is a UV barrier. Thus, incidence is similar among different ethnic backgrounds and skin tones. However, because melanomas in general are rare in people with darker skin, subungual melanomas make up a greater portion of melanomas among such persons, Dr. Scolyer noted.

NEW YORK — The combination of gabapentin with an antiviral and analgesics was more effective than were those drugs without gabapentin for reducing pain in patients with herpes zoster, suggesting that it may prevent postherpetic neuralgia in these patients, said Dr. Stephen Tyring, who presented as-yet-unpublished findings at the American Academy of Dermatology's Academy 2007 meeting.

Dr. Tyring, professor of dermatology, microbiology/molecular genetics, and internal medicine at the University of Texas, Houston, and colleagues enrolled 934 patients with herpes zoster whose pain measured at least a 4 on the Likert Pain Scale.

A control group of 800 patients received valacyclovir for 7 days along with various standard analgesics. An additional 134 patients also received gabapentin in the following regimen: 300 mg nightly for 1 week, followed by 300 mg three times daily for another week, then 600 mg t.i.d. for the following week, followed by yet another higher dosage until the patient complained of side effects (dizziness, drowsiness), at which point the dose was reduced to the highest tolerated dose and maintained until the end of the first month of treatment.

If, at that point, a patient's Likert score had dropped to below 4, the gabapentin was gradually discontinued over 3–4 days and the patient followed for 6 months. If the pain score was 4 or higher at the end of the fourth week, the patient received the highest tolerated dose of gabapentin for another 4 weeks and was then tapered off the drug.

Of those who received gabapentin in addition to valacyclovir and analgesics, only 12 patients (9%) had any pain at 6 months. In marked contrast, 33% of the 800 shingles patients who received valacyclovir and analgesics without gabapentin still had pain after 6 months. These results suggest that gabapentin may induce a neuroimmunomodulation of neuralgia, Dr. Tyring said.

The study was supported by GlaxoSmithKline, which provided the valacyclovir used.

Patients with a pain score of less than 4 were excluded “because the most effective predictor of postherpetic neuralgia, in addition to age, is degree of pain. So if the pain score has not even hit a 4 by the time they present to us with their vesicles, it will probably do no harm, but there's probably no benefit in giving the gabapentin or the pregabalin,” he said, noting that gabapentin is more economical than pregabalin (Lyrica).

'The most effective predictor of postherpetic neuralgia, in addition to age, is degree of pain.' DR. TYRING

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — The combination of gabapentin with an antiviral and analgesics was more effective than were those drugs without gabapentin for reducing pain in patients with herpes zoster, suggesting that it may prevent postherpetic neuralgia in these patients, said Dr. Stephen Tyring, who presented as-yet-unpublished findings at the American Academy of Dermatology's Academy 2007 meeting.

Dr. Tyring, professor of dermatology, microbiology/molecular genetics, and internal medicine at the University of Texas, Houston, and colleagues enrolled 934 patients with herpes zoster whose pain measured at least a 4 on the Likert Pain Scale.

A control group of 800 patients received valacyclovir for 7 days along with various standard analgesics. An additional 134 patients also received gabapentin in the following regimen: 300 mg nightly for 1 week, followed by 300 mg three times daily for another week, then 600 mg t.i.d. for the following week, followed by yet another higher dosage until the patient complained of side effects (dizziness, drowsiness), at which point the dose was reduced to the highest tolerated dose and maintained until the end of the first month of treatment.

If, at that point, a patient's Likert score had dropped to below 4, the gabapentin was gradually discontinued over 3–4 days and the patient followed for 6 months. If the pain score was 4 or higher at the end of the fourth week, the patient received the highest tolerated dose of gabapentin for another 4 weeks and was then tapered off the drug.

Of those who received gabapentin in addition to valacyclovir and analgesics, only 12 patients (9%) had any pain at 6 months. In marked contrast, 33% of the 800 shingles patients who received valacyclovir and analgesics without gabapentin still had pain after 6 months. These results suggest that gabapentin may induce a neuroimmunomodulation of neuralgia, Dr. Tyring said.

The study was supported by GlaxoSmithKline, which provided the valacyclovir used.

Patients with a pain score of less than 4 were excluded “because the most effective predictor of postherpetic neuralgia, in addition to age, is degree of pain. So if the pain score has not even hit a 4 by the time they present to us with their vesicles, it will probably do no harm, but there's probably no benefit in giving the gabapentin or the pregabalin,” he said, noting that gabapentin is more economical than pregabalin (Lyrica).

'The most effective predictor of postherpetic neuralgia, in addition to age, is degree of pain.' DR. TYRING

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — The combination of gabapentin with an antiviral and analgesics was more effective than were those drugs without gabapentin for reducing pain in patients with herpes zoster, suggesting that it may prevent postherpetic neuralgia in these patients, said Dr. Stephen Tyring, who presented as-yet-unpublished findings at the American Academy of Dermatology's Academy 2007 meeting.

Dr. Tyring, professor of dermatology, microbiology/molecular genetics, and internal medicine at the University of Texas, Houston, and colleagues enrolled 934 patients with herpes zoster whose pain measured at least a 4 on the Likert Pain Scale.

A control group of 800 patients received valacyclovir for 7 days along with various standard analgesics. An additional 134 patients also received gabapentin in the following regimen: 300 mg nightly for 1 week, followed by 300 mg three times daily for another week, then 600 mg t.i.d. for the following week, followed by yet another higher dosage until the patient complained of side effects (dizziness, drowsiness), at which point the dose was reduced to the highest tolerated dose and maintained until the end of the first month of treatment.

If, at that point, a patient's Likert score had dropped to below 4, the gabapentin was gradually discontinued over 3–4 days and the patient followed for 6 months. If the pain score was 4 or higher at the end of the fourth week, the patient received the highest tolerated dose of gabapentin for another 4 weeks and was then tapered off the drug.

Of those who received gabapentin in addition to valacyclovir and analgesics, only 12 patients (9%) had any pain at 6 months. In marked contrast, 33% of the 800 shingles patients who received valacyclovir and analgesics without gabapentin still had pain after 6 months. These results suggest that gabapentin may induce a neuroimmunomodulation of neuralgia, Dr. Tyring said.

The study was supported by GlaxoSmithKline, which provided the valacyclovir used.

Patients with a pain score of less than 4 were excluded “because the most effective predictor of postherpetic neuralgia, in addition to age, is degree of pain. So if the pain score has not even hit a 4 by the time they present to us with their vesicles, it will probably do no harm, but there's probably no benefit in giving the gabapentin or the pregabalin,” he said, noting that gabapentin is more economical than pregabalin (Lyrica).

'The most effective predictor of postherpetic neuralgia, in addition to age, is degree of pain.' DR. TYRING

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — Although melanoma is known for metastasizing to various sites, the most common site of metastasis is the locoregional lymph nodes, according to Dr. Richard Shapiro. They can be large and bulky or microscopic.

In a review of the literature on sentinel lymph node biopsy (SNLB), he noted that lymph node metastasis has been greatly associated with a decline in patient survival. However, "patients with nonpalpable, microscopic melanoma metastases tend to do much better than the patients who present with palpable metastases," he said at the American Academy of Dermatology's Academy 2007 meeting.

The thickness of a melanoma is key to its likelihood of having metastasized, he said. Thin melanomas—less than 0.76 mm in Breslow thickness—have a very small chance of having regional or distant metastases. However, patients with thick melanomas—4 mm or greater often have distant metastatic disease at presentation, said Dr. Shapiro of New York University, New York.

"It's the patients with so-called intermediate thickness lesions—that are approximately 0.76 mm to 4 mm thick—that have a much higher likelihood of having microscopic metastatic disease when they present than they do with having distant metastases. And so it would make sense in that intermediate thickness melanoma group to remove the lymph nodes in those patients and to see if we can decrease recurrence and increase survival."

Approximately 100 retrospective trials in the last 50 years have assessed associations between melanoma thickness and survival, with the only survival advantage seen in the patients with intermediate-thickness melanomas. However, prospective trials have found no survival advantage to elective lymph node dissection in patients with no clinical evidence of metastatic melanoma in the regional lymph nodes at presentation, Dr. Shapiro noted.

"Right now I would say the ideal candidate to undergo sentinel lymph node mapping and biopsy is the patient with a primary cutaneous melanoma 1 mm thick or greater, with no clinical evidence of regional lymph node metastases and in a patient where successful scintigraphy preoperatively can be performed and demonstrate regional lymph node draining," he said.

NEW YORK — Although melanoma is known for metastasizing to various sites, the most common site of metastasis is the locoregional lymph nodes, according to Dr. Richard Shapiro. They can be large and bulky or microscopic.

In a review of the literature on sentinel lymph node biopsy (SNLB), he noted that lymph node metastasis has been greatly associated with a decline in patient survival. However, "patients with nonpalpable, microscopic melanoma metastases tend to do much better than the patients who present with palpable metastases," he said at the American Academy of Dermatology's Academy 2007 meeting.

The thickness of a melanoma is key to its likelihood of having metastasized, he said. Thin melanomas—less than 0.76 mm in Breslow thickness—have a very small chance of having regional or distant metastases. However, patients with thick melanomas—4 mm or greater often have distant metastatic disease at presentation, said Dr. Shapiro of New York University, New York.

"It's the patients with so-called intermediate thickness lesions—that are approximately 0.76 mm to 4 mm thick—that have a much higher likelihood of having microscopic metastatic disease when they present than they do with having distant metastases. And so it would make sense in that intermediate thickness melanoma group to remove the lymph nodes in those patients and to see if we can decrease recurrence and increase survival."

Approximately 100 retrospective trials in the last 50 years have assessed associations between melanoma thickness and survival, with the only survival advantage seen in the patients with intermediate-thickness melanomas. However, prospective trials have found no survival advantage to elective lymph node dissection in patients with no clinical evidence of metastatic melanoma in the regional lymph nodes at presentation, Dr. Shapiro noted.

"Right now I would say the ideal candidate to undergo sentinel lymph node mapping and biopsy is the patient with a primary cutaneous melanoma 1 mm thick or greater, with no clinical evidence of regional lymph node metastases and in a patient where successful scintigraphy preoperatively can be performed and demonstrate regional lymph node draining," he said.

NEW YORK — Although melanoma is known for metastasizing to various sites, the most common site of metastasis is the locoregional lymph nodes, according to Dr. Richard Shapiro. They can be large and bulky or microscopic.

In a review of the literature on sentinel lymph node biopsy (SNLB), he noted that lymph node metastasis has been greatly associated with a decline in patient survival. However, "patients with nonpalpable, microscopic melanoma metastases tend to do much better than the patients who present with palpable metastases," he said at the American Academy of Dermatology's Academy 2007 meeting.

The thickness of a melanoma is key to its likelihood of having metastasized, he said. Thin melanomas—less than 0.76 mm in Breslow thickness—have a very small chance of having regional or distant metastases. However, patients with thick melanomas—4 mm or greater often have distant metastatic disease at presentation, said Dr. Shapiro of New York University, New York.

"It's the patients with so-called intermediate thickness lesions—that are approximately 0.76 mm to 4 mm thick—that have a much higher likelihood of having microscopic metastatic disease when they present than they do with having distant metastases. And so it would make sense in that intermediate thickness melanoma group to remove the lymph nodes in those patients and to see if we can decrease recurrence and increase survival."

Approximately 100 retrospective trials in the last 50 years have assessed associations between melanoma thickness and survival, with the only survival advantage seen in the patients with intermediate-thickness melanomas. However, prospective trials have found no survival advantage to elective lymph node dissection in patients with no clinical evidence of metastatic melanoma in the regional lymph nodes at presentation, Dr. Shapiro noted.

"Right now I would say the ideal candidate to undergo sentinel lymph node mapping and biopsy is the patient with a primary cutaneous melanoma 1 mm thick or greater, with no clinical evidence of regional lymph node metastases and in a patient where successful scintigraphy preoperatively can be performed and demonstrate regional lymph node draining," he said.

NEW YORK — Subclinical hypothyroidism with a thyroid-stimulating hormone level of 10–20 mU/L was associated with an almost twofold risk of heart failure in a study of more than 3,000 older adults.

The findings, presented by Dr. Douglas Bauer at the annual meeting of the American Thyroid Association, come from an analysis of participants in the prospective Cardiovascular Health Study, which includes persons from Medicare population-based listings at four university hospitals and is funded by the National Institutes of Health.

Dr. Bauer and his colleagues recruited 3,065 participants who were free of heart failure at baseline and not taking any medication known to affect thyroid function.

Any participants who initiated T4 replacement during the study were removed from the analysis, and 21 were excluded because of insufficient serum for testing. Participants were followed for 12 years and were contacted every 6 months for assessment of outcomes, said Dr. Bauer of the University of California, San Francisco.

Of the 495 participants (16%) with hypothyroidism, 448 had a TSH level between 4.5 mU/L and 9.9 mU/L and 47 had a TSH level of 10–20 mU/L. Hyperthyroidism (TSH level below 0.45 mU/L and normal T4 value) was found in 44 participants. All of the cases of hypothyroidism and hyperthyroidism in the study were subclinical.

Echocardiograms were obtained for all participants at baseline and at 5 years' follow-up and read by blinded physicians (including cardiologists). Some of the participants experienced heart failure before the 5-year follow-up, and their echocardiograms were also included.

At 12 years' follow-up, 660 persons (22%) had heart failure. In the 47 participants with a TSH level of 10–20 mU/L, there were 45 heart failure events per 1,000 person-years, compared with 22 events per 1,000 person-years in euthyroid participants. Multivariate analysis showed an unadjusted hazard ratio of 2.03 for those with a TSH level of 10–20 mU/L, versus euthyroid participants—a significant difference. (Adjusted for confounding factors, the hazard ratio was 1.88.) No increase in heart failure risk was seen in the hypothyroid participants with TSH levels of 4.5–9.9 mU/L or in euthyroid persons, versus those with TSH levels below that range. There was no difference in the heart failure rate between men and women.

Moreover, at 12 years, impaired cardiac function was associated with TSH levels of 10–20 mU/L: The percentage of participants who had an abnormal left ventricular ejection fraction at time of incident heart failure was 80% in the high-TSH hypothyroid group, compared with 39% in the lower-TSH hypothyroid group, 44% in the euthyroid group, and 33% in the hyperthyroid group.

Dr. Bauer and colleagues concluded that “subclinical hypothyroidism is associated with a moderately increased risk of clinical events of congestive heart failure among older individuals with a TSH greater than 10 [mU/L].”

He acknowledged that the study was limited by a shorter follow-up period for the echocardiography data than for the heart failure data (5 years vs. 12 years), as well as missing follow-up echocardiograms for some participants.

Several studies have established an association between subclinical hypothyroid and hyperthyroid disease and cardiac dysfunction, Dr. Bauer said. But most studies have looked at subtle abnormalities in contractility, rather than at more clinically important measures, such as left ventricular ejection fraction. Also, most of those studies have been limited by small sample sizes and lack of randomization.

NEW YORK — Subclinical hypothyroidism with a thyroid-stimulating hormone level of 10–20 mU/L was associated with an almost twofold risk of heart failure in a study of more than 3,000 older adults.

The findings, presented by Dr. Douglas Bauer at the annual meeting of the American Thyroid Association, come from an analysis of participants in the prospective Cardiovascular Health Study, which includes persons from Medicare population-based listings at four university hospitals and is funded by the National Institutes of Health.

Dr. Bauer and his colleagues recruited 3,065 participants who were free of heart failure at baseline and not taking any medication known to affect thyroid function.

Any participants who initiated T4 replacement during the study were removed from the analysis, and 21 were excluded because of insufficient serum for testing. Participants were followed for 12 years and were contacted every 6 months for assessment of outcomes, said Dr. Bauer of the University of California, San Francisco.

Of the 495 participants (16%) with hypothyroidism, 448 had a TSH level between 4.5 mU/L and 9.9 mU/L and 47 had a TSH level of 10–20 mU/L. Hyperthyroidism (TSH level below 0.45 mU/L and normal T4 value) was found in 44 participants. All of the cases of hypothyroidism and hyperthyroidism in the study were subclinical.

Echocardiograms were obtained for all participants at baseline and at 5 years' follow-up and read by blinded physicians (including cardiologists). Some of the participants experienced heart failure before the 5-year follow-up, and their echocardiograms were also included.

At 12 years' follow-up, 660 persons (22%) had heart failure. In the 47 participants with a TSH level of 10–20 mU/L, there were 45 heart failure events per 1,000 person-years, compared with 22 events per 1,000 person-years in euthyroid participants. Multivariate analysis showed an unadjusted hazard ratio of 2.03 for those with a TSH level of 10–20 mU/L, versus euthyroid participants—a significant difference. (Adjusted for confounding factors, the hazard ratio was 1.88.) No increase in heart failure risk was seen in the hypothyroid participants with TSH levels of 4.5–9.9 mU/L or in euthyroid persons, versus those with TSH levels below that range. There was no difference in the heart failure rate between men and women.

Moreover, at 12 years, impaired cardiac function was associated with TSH levels of 10–20 mU/L: The percentage of participants who had an abnormal left ventricular ejection fraction at time of incident heart failure was 80% in the high-TSH hypothyroid group, compared with 39% in the lower-TSH hypothyroid group, 44% in the euthyroid group, and 33% in the hyperthyroid group.

Dr. Bauer and colleagues concluded that “subclinical hypothyroidism is associated with a moderately increased risk of clinical events of congestive heart failure among older individuals with a TSH greater than 10 [mU/L].”

He acknowledged that the study was limited by a shorter follow-up period for the echocardiography data than for the heart failure data (5 years vs. 12 years), as well as missing follow-up echocardiograms for some participants.

Several studies have established an association between subclinical hypothyroid and hyperthyroid disease and cardiac dysfunction, Dr. Bauer said. But most studies have looked at subtle abnormalities in contractility, rather than at more clinically important measures, such as left ventricular ejection fraction. Also, most of those studies have been limited by small sample sizes and lack of randomization.

NEW YORK — Subclinical hypothyroidism with a thyroid-stimulating hormone level of 10–20 mU/L was associated with an almost twofold risk of heart failure in a study of more than 3,000 older adults.

The findings, presented by Dr. Douglas Bauer at the annual meeting of the American Thyroid Association, come from an analysis of participants in the prospective Cardiovascular Health Study, which includes persons from Medicare population-based listings at four university hospitals and is funded by the National Institutes of Health.

Dr. Bauer and his colleagues recruited 3,065 participants who were free of heart failure at baseline and not taking any medication known to affect thyroid function.

Any participants who initiated T4 replacement during the study were removed from the analysis, and 21 were excluded because of insufficient serum for testing. Participants were followed for 12 years and were contacted every 6 months for assessment of outcomes, said Dr. Bauer of the University of California, San Francisco.

Of the 495 participants (16%) with hypothyroidism, 448 had a TSH level between 4.5 mU/L and 9.9 mU/L and 47 had a TSH level of 10–20 mU/L. Hyperthyroidism (TSH level below 0.45 mU/L and normal T4 value) was found in 44 participants. All of the cases of hypothyroidism and hyperthyroidism in the study were subclinical.

Echocardiograms were obtained for all participants at baseline and at 5 years' follow-up and read by blinded physicians (including cardiologists). Some of the participants experienced heart failure before the 5-year follow-up, and their echocardiograms were also included.

At 12 years' follow-up, 660 persons (22%) had heart failure. In the 47 participants with a TSH level of 10–20 mU/L, there were 45 heart failure events per 1,000 person-years, compared with 22 events per 1,000 person-years in euthyroid participants. Multivariate analysis showed an unadjusted hazard ratio of 2.03 for those with a TSH level of 10–20 mU/L, versus euthyroid participants—a significant difference. (Adjusted for confounding factors, the hazard ratio was 1.88.) No increase in heart failure risk was seen in the hypothyroid participants with TSH levels of 4.5–9.9 mU/L or in euthyroid persons, versus those with TSH levels below that range. There was no difference in the heart failure rate between men and women.

Moreover, at 12 years, impaired cardiac function was associated with TSH levels of 10–20 mU/L: The percentage of participants who had an abnormal left ventricular ejection fraction at time of incident heart failure was 80% in the high-TSH hypothyroid group, compared with 39% in the lower-TSH hypothyroid group, 44% in the euthyroid group, and 33% in the hyperthyroid group.

Dr. Bauer and colleagues concluded that “subclinical hypothyroidism is associated with a moderately increased risk of clinical events of congestive heart failure among older individuals with a TSH greater than 10 [mU/L].”

He acknowledged that the study was limited by a shorter follow-up period for the echocardiography data than for the heart failure data (5 years vs. 12 years), as well as missing follow-up echocardiograms for some participants.

Several studies have established an association between subclinical hypothyroid and hyperthyroid disease and cardiac dysfunction, Dr. Bauer said. But most studies have looked at subtle abnormalities in contractility, rather than at more clinically important measures, such as left ventricular ejection fraction. Also, most of those studies have been limited by small sample sizes and lack of randomization.

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to actively maintain that coverage by making sure it is not disrupted when the time comes to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the idea will help them offset the higher cost of private insurance.

The encouragement of preventive care is another component. Participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.” So the program is building in an attempt to achieve quality standards.

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “It's a good thing. … With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, added Dr. Krotowski, who is also vice chair of the New York state chapter of the American Academy of Family Physicians.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20-$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

The opportunity costs of a program like this also have to be addressed, he said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat.” Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1. “We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the fourth, seventh, or ninth grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

'It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax.' DR. RACINE

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to actively maintain that coverage by making sure it is not disrupted when the time comes to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the idea will help them offset the higher cost of private insurance.

The encouragement of preventive care is another component. Participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.” So the program is building in an attempt to achieve quality standards.

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “It's a good thing. … With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, added Dr. Krotowski, who is also vice chair of the New York state chapter of the American Academy of Family Physicians.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20-$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

The opportunity costs of a program like this also have to be addressed, he said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat.” Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1. “We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the fourth, seventh, or ninth grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

'It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax.' DR. RACINE

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to actively maintain that coverage by making sure it is not disrupted when the time comes to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the idea will help them offset the higher cost of private insurance.

The encouragement of preventive care is another component. Participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.” So the program is building in an attempt to achieve quality standards.

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “It's a good thing. … With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, added Dr. Krotowski, who is also vice chair of the New York state chapter of the American Academy of Family Physicians.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20-$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

The opportunity costs of a program like this also have to be addressed, he said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat.” Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1. “We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the fourth, seventh, or ninth grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

'It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax.' DR. RACINE