Mary Ann Moon

Patients are less likely to comply with colorectal cancer screening if physicians recommend only colonoscopy than if they offer a choice of colonoscopy or fecal occult blood testing, according to a report in the April 9 issue of the Archives of Internal Medicine.

In a study of 997 middle-aged subjects at average risk of developing colorectal cancer who were making a routine visit to their primary care physician, only 38% of those advised to get a colonoscopy underwent any type of colorectal cancer screening during the ensuing year. In contrast, 67% of subjects advised to do fecal occult blood testing (FOBT) did so, and 69% of subjects who were given a choice between FOBT and colonoscopy underwent one of these types of colorectal cancer screening during the ensuing year, said Dr. John M. Inadomi of the division of gastroenterology, University of Washington, Seattle, and his associates.

No clinical trial in the United States to date has compared patient adherence to different colorectal screening strategies, and it is not known whether giving patients a choice of screening methods improves, reduces, or has no effect on adherence, they said.

Proponents of "choice" argue that increasing patients’ engagement in their health care and allowing for their individual preferences should promote adherence. But others counter that too much choice can impede adherence, with patients "defaulting to inertia" because they are confused or indecisive.

The investigators studied the issue by having primary care physicians at public health clinics randomly recommend one of three options for colorectal cancer screening to patients aged 50-79 years who were at average risk for the disease: colonoscopy only, FOBT only, or a choice between the two strategies.

The mean patient age was 58 years, and 53% of the study population were women. A total of 34% of the cohort were Hispanic, 30% were Asian (mainly Chinese), 18% were African American, 15% were white, and 4% were of other racial/ethnic backgrounds.

For FOBT, patients were given testing kits for home administration and were told to submit all three samples. Instructions were offered in the patients’ preferred language (English, Spanish, Cantonese, or Mandarin), said Dr. Inadomi, who is also at the GI health outcomes, policy, and economics research program at the University of California, San Francisco, and his colleagues.

For colonoscopy, patients were given standard information about the procedure and bowel preparation in their preferred language. Patients who agreed to colonoscopy were immediately scheduled for the procedure to be done within 2 weeks, which bypassed the preprocedure gastroenterology visit that often presents an obstacle to screening. They also were offered postprocedure transportation home, if they needed it.

Overall, 58% of the study cohort completed the colorectal cancer screening procedure that they were advised to, or chose to, do.

The proportion of patients who completed colonoscopy after being advised to undergo colonoscopy was 38.2%. This was substantially lower than the 67.2% of patients in the FOBT group who completed FOBT or the 68.8% of those in the "choice" group who completed their preferred screening method, the researchers said (Arch. Intern. Med. 2012;172:575-82).

The rate of adherence varied widely according to the study subjects’ racial/ethnic background. African Americans had the lowest overall rate of adherence (48%), while Hispanics (63%) and Asians (61%) had the highest.

Nonwhite subjects were much more likely to comply with FOBT, while whites were more likely to comply with colonoscopy.

Hispanic and Chinese patients who chose to communicate in Spanish, Cantonese, or Mandarin were more likely to adhere to screening than were those of the same ethnicity who chose to communicate in English.

The study results show that limiting the recommendation for colorectal cancer screening to colonoscopy alone actually reduces the completion rate for screening, compared with giving patients a choice between colonoscopy and FOBT.

The findings also demonstrate that "a relatively high level of adherence to colorectal cancer screening can be achieved in low-income racial/ethnic minorities when barriers to access are reduced," the investigators added.

This study was supported by the National Cancer Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources. The investigators reported no relevant financial disclosures.

Patients are less likely to comply with colorectal cancer screening if physicians recommend only colonoscopy than if they offer a choice of colonoscopy or fecal occult blood testing, according to a report in the April 9 issue of the Archives of Internal Medicine.

In a study of 997 middle-aged subjects at average risk of developing colorectal cancer who were making a routine visit to their primary care physician, only 38% of those advised to get a colonoscopy underwent any type of colorectal cancer screening during the ensuing year. In contrast, 67% of subjects advised to do fecal occult blood testing (FOBT) did so, and 69% of subjects who were given a choice between FOBT and colonoscopy underwent one of these types of colorectal cancer screening during the ensuing year, said Dr. John M. Inadomi of the division of gastroenterology, University of Washington, Seattle, and his associates.

No clinical trial in the United States to date has compared patient adherence to different colorectal screening strategies, and it is not known whether giving patients a choice of screening methods improves, reduces, or has no effect on adherence, they said.

Proponents of "choice" argue that increasing patients’ engagement in their health care and allowing for their individual preferences should promote adherence. But others counter that too much choice can impede adherence, with patients "defaulting to inertia" because they are confused or indecisive.

The investigators studied the issue by having primary care physicians at public health clinics randomly recommend one of three options for colorectal cancer screening to patients aged 50-79 years who were at average risk for the disease: colonoscopy only, FOBT only, or a choice between the two strategies.

The mean patient age was 58 years, and 53% of the study population were women. A total of 34% of the cohort were Hispanic, 30% were Asian (mainly Chinese), 18% were African American, 15% were white, and 4% were of other racial/ethnic backgrounds.

For FOBT, patients were given testing kits for home administration and were told to submit all three samples. Instructions were offered in the patients’ preferred language (English, Spanish, Cantonese, or Mandarin), said Dr. Inadomi, who is also at the GI health outcomes, policy, and economics research program at the University of California, San Francisco, and his colleagues.

For colonoscopy, patients were given standard information about the procedure and bowel preparation in their preferred language. Patients who agreed to colonoscopy were immediately scheduled for the procedure to be done within 2 weeks, which bypassed the preprocedure gastroenterology visit that often presents an obstacle to screening. They also were offered postprocedure transportation home, if they needed it.

Overall, 58% of the study cohort completed the colorectal cancer screening procedure that they were advised to, or chose to, do.

The proportion of patients who completed colonoscopy after being advised to undergo colonoscopy was 38.2%. This was substantially lower than the 67.2% of patients in the FOBT group who completed FOBT or the 68.8% of those in the "choice" group who completed their preferred screening method, the researchers said (Arch. Intern. Med. 2012;172:575-82).

The rate of adherence varied widely according to the study subjects’ racial/ethnic background. African Americans had the lowest overall rate of adherence (48%), while Hispanics (63%) and Asians (61%) had the highest.

Nonwhite subjects were much more likely to comply with FOBT, while whites were more likely to comply with colonoscopy.

Hispanic and Chinese patients who chose to communicate in Spanish, Cantonese, or Mandarin were more likely to adhere to screening than were those of the same ethnicity who chose to communicate in English.

The study results show that limiting the recommendation for colorectal cancer screening to colonoscopy alone actually reduces the completion rate for screening, compared with giving patients a choice between colonoscopy and FOBT.

The findings also demonstrate that "a relatively high level of adherence to colorectal cancer screening can be achieved in low-income racial/ethnic minorities when barriers to access are reduced," the investigators added.

This study was supported by the National Cancer Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources. The investigators reported no relevant financial disclosures.

Patients are less likely to comply with colorectal cancer screening if physicians recommend only colonoscopy than if they offer a choice of colonoscopy or fecal occult blood testing, according to a report in the April 9 issue of the Archives of Internal Medicine.

In a study of 997 middle-aged subjects at average risk of developing colorectal cancer who were making a routine visit to their primary care physician, only 38% of those advised to get a colonoscopy underwent any type of colorectal cancer screening during the ensuing year. In contrast, 67% of subjects advised to do fecal occult blood testing (FOBT) did so, and 69% of subjects who were given a choice between FOBT and colonoscopy underwent one of these types of colorectal cancer screening during the ensuing year, said Dr. John M. Inadomi of the division of gastroenterology, University of Washington, Seattle, and his associates.

No clinical trial in the United States to date has compared patient adherence to different colorectal screening strategies, and it is not known whether giving patients a choice of screening methods improves, reduces, or has no effect on adherence, they said.

Proponents of "choice" argue that increasing patients’ engagement in their health care and allowing for their individual preferences should promote adherence. But others counter that too much choice can impede adherence, with patients "defaulting to inertia" because they are confused or indecisive.

The investigators studied the issue by having primary care physicians at public health clinics randomly recommend one of three options for colorectal cancer screening to patients aged 50-79 years who were at average risk for the disease: colonoscopy only, FOBT only, or a choice between the two strategies.

The mean patient age was 58 years, and 53% of the study population were women. A total of 34% of the cohort were Hispanic, 30% were Asian (mainly Chinese), 18% were African American, 15% were white, and 4% were of other racial/ethnic backgrounds.

For FOBT, patients were given testing kits for home administration and were told to submit all three samples. Instructions were offered in the patients’ preferred language (English, Spanish, Cantonese, or Mandarin), said Dr. Inadomi, who is also at the GI health outcomes, policy, and economics research program at the University of California, San Francisco, and his colleagues.

For colonoscopy, patients were given standard information about the procedure and bowel preparation in their preferred language. Patients who agreed to colonoscopy were immediately scheduled for the procedure to be done within 2 weeks, which bypassed the preprocedure gastroenterology visit that often presents an obstacle to screening. They also were offered postprocedure transportation home, if they needed it.

Overall, 58% of the study cohort completed the colorectal cancer screening procedure that they were advised to, or chose to, do.

The proportion of patients who completed colonoscopy after being advised to undergo colonoscopy was 38.2%. This was substantially lower than the 67.2% of patients in the FOBT group who completed FOBT or the 68.8% of those in the "choice" group who completed their preferred screening method, the researchers said (Arch. Intern. Med. 2012;172:575-82).

The rate of adherence varied widely according to the study subjects’ racial/ethnic background. African Americans had the lowest overall rate of adherence (48%), while Hispanics (63%) and Asians (61%) had the highest.

Nonwhite subjects were much more likely to comply with FOBT, while whites were more likely to comply with colonoscopy.

Hispanic and Chinese patients who chose to communicate in Spanish, Cantonese, or Mandarin were more likely to adhere to screening than were those of the same ethnicity who chose to communicate in English.

The study results show that limiting the recommendation for colorectal cancer screening to colonoscopy alone actually reduces the completion rate for screening, compared with giving patients a choice between colonoscopy and FOBT.

The findings also demonstrate that "a relatively high level of adherence to colorectal cancer screening can be achieved in low-income racial/ethnic minorities when barriers to access are reduced," the investigators added.

This study was supported by the National Cancer Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources. The investigators reported no relevant financial disclosures.

Older men and women who took vitamin B, omega-3 fatty acids, or a combination of both supplements for approximately 5 years were no less likely to develop cancer than those who took placebo, according to a randomized clinical trial reported in the April 9 issue of Archives of Internal Medicine.

"This study does not support dietary use of B vitamins or omega-3 fatty acids for cancer prevention," said Valentina A. Andreeva, Ph.D., of the nutritional epidemiology research unit, University of Paris, and her associates.

The B vitamins have been proposed as potential cancer prevention therapy because deficiency of these nutrients is thought to affect DNA methylation, which in turn modulates cell differentiation and chromosomal stability. Similarly, omega-3 fatty acids have been suggested as chemoprevention because they may restrict tumor cell proliferation, and they modulate inflammation and immunity.

However, research regarding both nutrients has yielded inconclusive results. Dr. Andreeva and her colleagues studied the issue using data from a randomized clinical trial of cardiovascular disease. In that trial, 2,501 patients aged 45-80 years who had had an acute myocardial infarction, unstable angina, or ischemic stroke during the preceding year were randomly assigned to one of four supplementation groups and followed for a mean of 5 years for recurrent cardiovascular disease–related events.

The vitamin B and fatty acid supplements were not found to affect cardiovascular disease recurrence in that trial.

In their secondary analysis of the data, Dr. Andreeva and her associates instead assessed the development of incident cancer in these study subjects. The 1,987 men and 514 women had a mean age of 61 years at baseline. They were assigned to take 2 oral capsules each day.

The first group took B vitamins 5-methyltetrahydrofolate (0.56 mg), pyridoxine HCl (vitman B₆, 3 mg), and cyanocobalamin (vitamin B₁₂, 0.02 mg); the second group took eicosapentaenoic and docosahexaenoic acids (600 mg); the third group took both types of supplement; and the fourth group took oral placebos.

Treatment adherence was judged to be high, based on subjects’ self-report and on their increased blood levels of both nutrients.

During follow-up, 174 subjects (7%) developed an incident primary cancer. A total of 145 men developed prostate (50 cases), lung (22 cases), bladder (16 cases), colorectal (13 cases), or other (44 cases) malignancies. Twenty-nine women developed breast (9 cases), lung (4 cases), colorectal (3 cases), or other (13) malignancies.

Neither B vitamins nor omega-3 fatty acids affected the incidence of cancer, the investigators said (Arch. Intern. Med. 2012;172:540-7). Among men, 74 who took B vitamins developed cancer, compared with 71 in the comparison groups, a nonsignificant difference. Similarly, 72 men who took fatty-acid supplements developed cancer, compared with 73 in the comparison groups, also a nonsignificant difference.

Among women, 20 who took B vitamins and 9 in the comparison groups developed cancer, a difference of borderline significance. And 21 who took fatty acid supplements developed cancer, compared with 8 in the comparison groups. This difference was significant, but the low number of cancer cases in women "resulted in unstable and equivocal risk estimates," the researchers said.

This study was supported by Candia, Danone, Merck Eprova AG, Pierre Fabre Laboratories, Roche Laboratories, Sodexo, Unilever, the French National Research Agency, and the French Ministry of Health. The investigators reported no relevant financial disclosures.

Older men and women who took vitamin B, omega-3 fatty acids, or a combination of both supplements for approximately 5 years were no less likely to develop cancer than those who took placebo, according to a randomized clinical trial reported in the April 9 issue of Archives of Internal Medicine.

"This study does not support dietary use of B vitamins or omega-3 fatty acids for cancer prevention," said Valentina A. Andreeva, Ph.D., of the nutritional epidemiology research unit, University of Paris, and her associates.

The B vitamins have been proposed as potential cancer prevention therapy because deficiency of these nutrients is thought to affect DNA methylation, which in turn modulates cell differentiation and chromosomal stability. Similarly, omega-3 fatty acids have been suggested as chemoprevention because they may restrict tumor cell proliferation, and they modulate inflammation and immunity.

However, research regarding both nutrients has yielded inconclusive results. Dr. Andreeva and her colleagues studied the issue using data from a randomized clinical trial of cardiovascular disease. In that trial, 2,501 patients aged 45-80 years who had had an acute myocardial infarction, unstable angina, or ischemic stroke during the preceding year were randomly assigned to one of four supplementation groups and followed for a mean of 5 years for recurrent cardiovascular disease–related events.

The vitamin B and fatty acid supplements were not found to affect cardiovascular disease recurrence in that trial.

In their secondary analysis of the data, Dr. Andreeva and her associates instead assessed the development of incident cancer in these study subjects. The 1,987 men and 514 women had a mean age of 61 years at baseline. They were assigned to take 2 oral capsules each day.

The first group took B vitamins 5-methyltetrahydrofolate (0.56 mg), pyridoxine HCl (vitman B₆, 3 mg), and cyanocobalamin (vitamin B₁₂, 0.02 mg); the second group took eicosapentaenoic and docosahexaenoic acids (600 mg); the third group took both types of supplement; and the fourth group took oral placebos.

Treatment adherence was judged to be high, based on subjects’ self-report and on their increased blood levels of both nutrients.

During follow-up, 174 subjects (7%) developed an incident primary cancer. A total of 145 men developed prostate (50 cases), lung (22 cases), bladder (16 cases), colorectal (13 cases), or other (44 cases) malignancies. Twenty-nine women developed breast (9 cases), lung (4 cases), colorectal (3 cases), or other (13) malignancies.

Neither B vitamins nor omega-3 fatty acids affected the incidence of cancer, the investigators said (Arch. Intern. Med. 2012;172:540-7). Among men, 74 who took B vitamins developed cancer, compared with 71 in the comparison groups, a nonsignificant difference. Similarly, 72 men who took fatty-acid supplements developed cancer, compared with 73 in the comparison groups, also a nonsignificant difference.

Among women, 20 who took B vitamins and 9 in the comparison groups developed cancer, a difference of borderline significance. And 21 who took fatty acid supplements developed cancer, compared with 8 in the comparison groups. This difference was significant, but the low number of cancer cases in women "resulted in unstable and equivocal risk estimates," the researchers said.

This study was supported by Candia, Danone, Merck Eprova AG, Pierre Fabre Laboratories, Roche Laboratories, Sodexo, Unilever, the French National Research Agency, and the French Ministry of Health. The investigators reported no relevant financial disclosures.

Older men and women who took vitamin B, omega-3 fatty acids, or a combination of both supplements for approximately 5 years were no less likely to develop cancer than those who took placebo, according to a randomized clinical trial reported in the April 9 issue of Archives of Internal Medicine.

"This study does not support dietary use of B vitamins or omega-3 fatty acids for cancer prevention," said Valentina A. Andreeva, Ph.D., of the nutritional epidemiology research unit, University of Paris, and her associates.

The B vitamins have been proposed as potential cancer prevention therapy because deficiency of these nutrients is thought to affect DNA methylation, which in turn modulates cell differentiation and chromosomal stability. Similarly, omega-3 fatty acids have been suggested as chemoprevention because they may restrict tumor cell proliferation, and they modulate inflammation and immunity.

However, research regarding both nutrients has yielded inconclusive results. Dr. Andreeva and her colleagues studied the issue using data from a randomized clinical trial of cardiovascular disease. In that trial, 2,501 patients aged 45-80 years who had had an acute myocardial infarction, unstable angina, or ischemic stroke during the preceding year were randomly assigned to one of four supplementation groups and followed for a mean of 5 years for recurrent cardiovascular disease–related events.

The vitamin B and fatty acid supplements were not found to affect cardiovascular disease recurrence in that trial.

In their secondary analysis of the data, Dr. Andreeva and her associates instead assessed the development of incident cancer in these study subjects. The 1,987 men and 514 women had a mean age of 61 years at baseline. They were assigned to take 2 oral capsules each day.

The first group took B vitamins 5-methyltetrahydrofolate (0.56 mg), pyridoxine HCl (vitman B₆, 3 mg), and cyanocobalamin (vitamin B₁₂, 0.02 mg); the second group took eicosapentaenoic and docosahexaenoic acids (600 mg); the third group took both types of supplement; and the fourth group took oral placebos.

Treatment adherence was judged to be high, based on subjects’ self-report and on their increased blood levels of both nutrients.

During follow-up, 174 subjects (7%) developed an incident primary cancer. A total of 145 men developed prostate (50 cases), lung (22 cases), bladder (16 cases), colorectal (13 cases), or other (44 cases) malignancies. Twenty-nine women developed breast (9 cases), lung (4 cases), colorectal (3 cases), or other (13) malignancies.

Neither B vitamins nor omega-3 fatty acids affected the incidence of cancer, the investigators said (Arch. Intern. Med. 2012;172:540-7). Among men, 74 who took B vitamins developed cancer, compared with 71 in the comparison groups, a nonsignificant difference. Similarly, 72 men who took fatty-acid supplements developed cancer, compared with 73 in the comparison groups, also a nonsignificant difference.

Among women, 20 who took B vitamins and 9 in the comparison groups developed cancer, a difference of borderline significance. And 21 who took fatty acid supplements developed cancer, compared with 8 in the comparison groups. This difference was significant, but the low number of cancer cases in women "resulted in unstable and equivocal risk estimates," the researchers said.

This study was supported by Candia, Danone, Merck Eprova AG, Pierre Fabre Laboratories, Roche Laboratories, Sodexo, Unilever, the French National Research Agency, and the French Ministry of Health. The investigators reported no relevant financial disclosures.

Monitoring of rates of surgical site infection, as well as reporting of those rates to the public, vary dramatically from state to state, according to a study published online March 2 in the Journal for Healthcare Quality.

Monitoring and publicly reporting data on surgical site infections (SSIs) has been demonstrated to markedly improve patient outcomes, and the Centers for Medicare and Medicaid Services recently announced that hospitals must report such data (for certain procedures) and meet benchmarks to avoid financial penalties. Yet currently there is no standardized system for collecting or reporting SSI data, with each state addressing the issue through its own individual laws, regulations, or "plans," said Dr. Martin A. Makary, a laparoscopic and pancreatic surgeon at Johns Hopkins University, Baltimore, and his associates.

"It is critical to standardize the reporting process before SSIs are incorporated into the Medicare payment scheme," they noted.

Dr. Makary and his colleagues reviewed the legislation on SSI monitoring and reporting for all 50 states and the District of Columbia, then assessed each state’s actual reporting of such data for a single month – September 2010.

They found that only 21 states mandate the monitoring of SSI rates and only 20 require public reporting; the remaining states had no such laws. And despite these legal mandates, only 8 of the 21 states had SSI data available in an easily accessible manner.

These states were South Carolina, Missouri, Colorado, Massachusetts, New York, Ohio, Vermont, and Oregon.

Among these eight states, SSI reporting still varied widely, with each state tracking different procedures. Seven states reported on CABG, six on hip or knee replacements, four on hysterectomies, and two each on colon surgeries or herniorrphaphies. One state reported on breast surgeries, one on gallbladder procedures, one on cesarean sections, and one on spinal fusions.

"Interestingly, colon surgery, which has the highest rate of SSIs nationally, was only reported by two states. And gallbladder surgery, which is among the most common surgical procedures ... was only reported by one state," the investigators said (J. Healthc. Qual. 2012 March 2 [doi: 10.1111/j.1945-1474.2011.00176.x]).

The data collection itself varied greatly by state. For example, some states monitored only in-hospital SSIs for colorectal surgery, while others monitored 30-day SSIs for the same procedure. This resulted in a nearly 40% discrepancy in colorectal SSIs between these states, since many of these infections don’t develop until after hospital discharge, the researchers said.

The lag time between collection of the information and its publication tended to be long, with some states failing to post their SSI data until 11 months after it was obtained.

"Without the same quality and type of data, it is difficult for consumers, payers, or regulators to compare infections within or across states, potentially making inaccurate inferences about the quality of care," Dr. Makary and his associates said.

"Our study highlights the need for the federal government to set the rules for how hospitals define, monitor, and report SSIs," they added.

No conflicts of interest were reported.

Monitoring of rates of surgical site infection, as well as reporting of those rates to the public, vary dramatically from state to state, according to a study published online March 2 in the Journal for Healthcare Quality.

Monitoring and publicly reporting data on surgical site infections (SSIs) has been demonstrated to markedly improve patient outcomes, and the Centers for Medicare and Medicaid Services recently announced that hospitals must report such data (for certain procedures) and meet benchmarks to avoid financial penalties. Yet currently there is no standardized system for collecting or reporting SSI data, with each state addressing the issue through its own individual laws, regulations, or "plans," said Dr. Martin A. Makary, a laparoscopic and pancreatic surgeon at Johns Hopkins University, Baltimore, and his associates.

"It is critical to standardize the reporting process before SSIs are incorporated into the Medicare payment scheme," they noted.

Dr. Makary and his colleagues reviewed the legislation on SSI monitoring and reporting for all 50 states and the District of Columbia, then assessed each state’s actual reporting of such data for a single month – September 2010.

They found that only 21 states mandate the monitoring of SSI rates and only 20 require public reporting; the remaining states had no such laws. And despite these legal mandates, only 8 of the 21 states had SSI data available in an easily accessible manner.

These states were South Carolina, Missouri, Colorado, Massachusetts, New York, Ohio, Vermont, and Oregon.

Among these eight states, SSI reporting still varied widely, with each state tracking different procedures. Seven states reported on CABG, six on hip or knee replacements, four on hysterectomies, and two each on colon surgeries or herniorrphaphies. One state reported on breast surgeries, one on gallbladder procedures, one on cesarean sections, and one on spinal fusions.

"Interestingly, colon surgery, which has the highest rate of SSIs nationally, was only reported by two states. And gallbladder surgery, which is among the most common surgical procedures ... was only reported by one state," the investigators said (J. Healthc. Qual. 2012 March 2 [doi: 10.1111/j.1945-1474.2011.00176.x]).

The data collection itself varied greatly by state. For example, some states monitored only in-hospital SSIs for colorectal surgery, while others monitored 30-day SSIs for the same procedure. This resulted in a nearly 40% discrepancy in colorectal SSIs between these states, since many of these infections don’t develop until after hospital discharge, the researchers said.

The lag time between collection of the information and its publication tended to be long, with some states failing to post their SSI data until 11 months after it was obtained.

"Without the same quality and type of data, it is difficult for consumers, payers, or regulators to compare infections within or across states, potentially making inaccurate inferences about the quality of care," Dr. Makary and his associates said.

"Our study highlights the need for the federal government to set the rules for how hospitals define, monitor, and report SSIs," they added.

No conflicts of interest were reported.

Monitoring of rates of surgical site infection, as well as reporting of those rates to the public, vary dramatically from state to state, according to a study published online March 2 in the Journal for Healthcare Quality.

Monitoring and publicly reporting data on surgical site infections (SSIs) has been demonstrated to markedly improve patient outcomes, and the Centers for Medicare and Medicaid Services recently announced that hospitals must report such data (for certain procedures) and meet benchmarks to avoid financial penalties. Yet currently there is no standardized system for collecting or reporting SSI data, with each state addressing the issue through its own individual laws, regulations, or "plans," said Dr. Martin A. Makary, a laparoscopic and pancreatic surgeon at Johns Hopkins University, Baltimore, and his associates.

"It is critical to standardize the reporting process before SSIs are incorporated into the Medicare payment scheme," they noted.

Dr. Makary and his colleagues reviewed the legislation on SSI monitoring and reporting for all 50 states and the District of Columbia, then assessed each state’s actual reporting of such data for a single month – September 2010.

They found that only 21 states mandate the monitoring of SSI rates and only 20 require public reporting; the remaining states had no such laws. And despite these legal mandates, only 8 of the 21 states had SSI data available in an easily accessible manner.

These states were South Carolina, Missouri, Colorado, Massachusetts, New York, Ohio, Vermont, and Oregon.

Among these eight states, SSI reporting still varied widely, with each state tracking different procedures. Seven states reported on CABG, six on hip or knee replacements, four on hysterectomies, and two each on colon surgeries or herniorrphaphies. One state reported on breast surgeries, one on gallbladder procedures, one on cesarean sections, and one on spinal fusions.

"Interestingly, colon surgery, which has the highest rate of SSIs nationally, was only reported by two states. And gallbladder surgery, which is among the most common surgical procedures ... was only reported by one state," the investigators said (J. Healthc. Qual. 2012 March 2 [doi: 10.1111/j.1945-1474.2011.00176.x]).

The data collection itself varied greatly by state. For example, some states monitored only in-hospital SSIs for colorectal surgery, while others monitored 30-day SSIs for the same procedure. This resulted in a nearly 40% discrepancy in colorectal SSIs between these states, since many of these infections don’t develop until after hospital discharge, the researchers said.

The lag time between collection of the information and its publication tended to be long, with some states failing to post their SSI data until 11 months after it was obtained.

"Without the same quality and type of data, it is difficult for consumers, payers, or regulators to compare infections within or across states, potentially making inaccurate inferences about the quality of care," Dr. Makary and his associates said.

"Our study highlights the need for the federal government to set the rules for how hospitals define, monitor, and report SSIs," they added.

No conflicts of interest were reported.

People who receive a cancer diagnosis are at markedly increased risk for suicide and for fatal cardiovascular events in the following weeks, according to a large Swedish cohort study reported in the April 5 issue of the New England Journal of Medicine.

"This spike in risk was particularly prominent among patients in whom cancers with a poor prognosis were diagnosed, and was not explained by preexisting psychiatric or cardiovascular conditions," said Dr. Fang Fang of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and her associates.

The dramatic increase in mortality risk from suicide or cardiovascular causes also cannot be attributed to cancer treatment or cancer progression, since it peaks during the first week after diagnosis and declined over time rather than increasing as treatment intensified or disease worsened, they noted.

Previous studies have demonstrated that cancer patients are at increased risk for suicide and CV events, but most have attributed it to "the burden of living with a progressing cancer." Very few have explored the period immediately following a cancer diagnosis, Dr. Fang and her colleagues said.

They examined this time period using data from a Swedish national registry of cancers and causes of death, both of which must be reported by law in Sweden. The study period, 1991 through 2006, covered more than 6 million Swedes aged 30 and older at baseline.

A total of 534,154 people received a first cancer diagnosis during this interval, including 95,786 with prostate cancer, 74,977 with breast cancer (among women), 62,719 with colorectal cancer, 47,169 with skin cancer, 36,648 with lymphatic or hematopoietic cancer, 34,743 with lung cancer, and 13,447 with CNS cancer. Another 26,335 patients were pooled in a single category of "highly fatal cancers of the esophagus, liver, and pancreas," and the remaining 142,330 patients had other types of cancer.

During follow-up, there were 786 completed suicides among patients with any type of cancer, for a rate of 0.36 per 1,000 person-years. This was double the rate among Swedish adults who did not have cancer: 13,284 completed suicides for a rate of 0.18 per 1,000 person-years (N. Engl. J. Med. 2012;366:1310-8).

The rate of completed suicides peaked during the first week after cancer diagnosis, at 2.50 per 1,000 person-years.

"We found a relative risk of 4.8 during the first 12 weeks after diagnosis (110 patients; incidence rate, 0.95 per 1,000 person-years), with the highest relative risk observed for highly fatal cancers of the esophagus, liver, or pancreas, followed by lung cancer," they added.

The magnitude of elevated risk dropped rapidly after that, but remained higher than average beyond the first year for all cancers.

"Focusing on the first 52 weeks after a diagnosis of any cancer, we found a relative risk of 3.1 for suicide (260 patients; incidence rate, 0.60 per 1,000 person-years). The expected number of suicides, adjusted for all demographic factors, during these 52 weeks was 87, leaving 173 cases associated with cancer diagnoses," the researchers said.

The relative risks of suicide were stronger among patients who had no concomitant psychiatric disorders than among those with psychiatric disorders.

Turning to fatal cardiovascular events, there were 48,991 CV deaths among people who received a diagnosis of any cancer, for an incidence of 23.10 per 1,000 person-years. This rate is approximately three times higher than that for people who did not have cancer (543,144 deaths; incidence rate, 7.53 per 1,000 person-years.

As with suicide, the highest relative risk of CV death (5.6) peaked during the first week after diagnosis (1,318 patients; incidence rate, 116.8 per 1,000 person-years). The risk elevation was highest for central nervous system cancers, followed by highly fatal cancers of the esophagus, liver, or pancreas, and then by lung cancer.

Also as with suicide, the magnitude of the increased risk of CV death dropped rapidly after the first several weeks. It did not persist beyond the first year after diagnosis.

"Focusing on the first 4 weeks after a diagnosis of any cancer but CNS tumors, we found a relative risk of 3.3 for cardiovascular death (2,641 patients; incidence rate, 65.81 per 1,000 person-years). The adjusted expected number of CV deaths was 766 during these 4 weeks, leaving 1,875 deaths associated with a cancer diagnosis," the investigators said.

Of note was the finding that the increased hazards were seen in both men and women.

To adjust for unmeasured confounders, the researchers performed an additional case-crossover analysis among all cancer patients in the cohort who died from suicide or CV causes. The results "further allayed the concern" that there may be some alternative explanation for the observed associations, such as an unknown factor that causes cancer, suicide, and CV death.

Dr. Fang and her associates emphasized that their study "focused on hard outcomes alone, and thus probably did not capture the full extent of the psychological burden among patients with newly diagnosed cancer. Other potentially relevant outcomes, such as attempted suicide and severe but nonfatal CV events, remain to be explored," they noted.

In addition, this study involved only adults aged 30 years and older. Further studies are warranted to examine the immediate after-effects of a cancer diagnosis in children, adolescents, and young adults.

Most importantly, now that these elevated risks have been identified, future research must address prevention strategies, they said.

This study was supported by the Swedish Council for Working Life and Social Research, the Swedish Research Council, Hjärnfonden, and Svenska Sällskapet för Medicinsk Forskning. No financial conflicts of interest were reported.

People who receive a cancer diagnosis are at markedly increased risk for suicide and for fatal cardiovascular events in the following weeks, according to a large Swedish cohort study reported in the April 5 issue of the New England Journal of Medicine.

"This spike in risk was particularly prominent among patients in whom cancers with a poor prognosis were diagnosed, and was not explained by preexisting psychiatric or cardiovascular conditions," said Dr. Fang Fang of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and her associates.

The dramatic increase in mortality risk from suicide or cardiovascular causes also cannot be attributed to cancer treatment or cancer progression, since it peaks during the first week after diagnosis and declined over time rather than increasing as treatment intensified or disease worsened, they noted.

Previous studies have demonstrated that cancer patients are at increased risk for suicide and CV events, but most have attributed it to "the burden of living with a progressing cancer." Very few have explored the period immediately following a cancer diagnosis, Dr. Fang and her colleagues said.

They examined this time period using data from a Swedish national registry of cancers and causes of death, both of which must be reported by law in Sweden. The study period, 1991 through 2006, covered more than 6 million Swedes aged 30 and older at baseline.

A total of 534,154 people received a first cancer diagnosis during this interval, including 95,786 with prostate cancer, 74,977 with breast cancer (among women), 62,719 with colorectal cancer, 47,169 with skin cancer, 36,648 with lymphatic or hematopoietic cancer, 34,743 with lung cancer, and 13,447 with CNS cancer. Another 26,335 patients were pooled in a single category of "highly fatal cancers of the esophagus, liver, and pancreas," and the remaining 142,330 patients had other types of cancer.

During follow-up, there were 786 completed suicides among patients with any type of cancer, for a rate of 0.36 per 1,000 person-years. This was double the rate among Swedish adults who did not have cancer: 13,284 completed suicides for a rate of 0.18 per 1,000 person-years (N. Engl. J. Med. 2012;366:1310-8).

The rate of completed suicides peaked during the first week after cancer diagnosis, at 2.50 per 1,000 person-years.

"We found a relative risk of 4.8 during the first 12 weeks after diagnosis (110 patients; incidence rate, 0.95 per 1,000 person-years), with the highest relative risk observed for highly fatal cancers of the esophagus, liver, or pancreas, followed by lung cancer," they added.

The magnitude of elevated risk dropped rapidly after that, but remained higher than average beyond the first year for all cancers.

"Focusing on the first 52 weeks after a diagnosis of any cancer, we found a relative risk of 3.1 for suicide (260 patients; incidence rate, 0.60 per 1,000 person-years). The expected number of suicides, adjusted for all demographic factors, during these 52 weeks was 87, leaving 173 cases associated with cancer diagnoses," the researchers said.

The relative risks of suicide were stronger among patients who had no concomitant psychiatric disorders than among those with psychiatric disorders.

Turning to fatal cardiovascular events, there were 48,991 CV deaths among people who received a diagnosis of any cancer, for an incidence of 23.10 per 1,000 person-years. This rate is approximately three times higher than that for people who did not have cancer (543,144 deaths; incidence rate, 7.53 per 1,000 person-years.

As with suicide, the highest relative risk of CV death (5.6) peaked during the first week after diagnosis (1,318 patients; incidence rate, 116.8 per 1,000 person-years). The risk elevation was highest for central nervous system cancers, followed by highly fatal cancers of the esophagus, liver, or pancreas, and then by lung cancer.

Also as with suicide, the magnitude of the increased risk of CV death dropped rapidly after the first several weeks. It did not persist beyond the first year after diagnosis.

"Focusing on the first 4 weeks after a diagnosis of any cancer but CNS tumors, we found a relative risk of 3.3 for cardiovascular death (2,641 patients; incidence rate, 65.81 per 1,000 person-years). The adjusted expected number of CV deaths was 766 during these 4 weeks, leaving 1,875 deaths associated with a cancer diagnosis," the investigators said.

Of note was the finding that the increased hazards were seen in both men and women.

To adjust for unmeasured confounders, the researchers performed an additional case-crossover analysis among all cancer patients in the cohort who died from suicide or CV causes. The results "further allayed the concern" that there may be some alternative explanation for the observed associations, such as an unknown factor that causes cancer, suicide, and CV death.

Dr. Fang and her associates emphasized that their study "focused on hard outcomes alone, and thus probably did not capture the full extent of the psychological burden among patients with newly diagnosed cancer. Other potentially relevant outcomes, such as attempted suicide and severe but nonfatal CV events, remain to be explored," they noted.

In addition, this study involved only adults aged 30 years and older. Further studies are warranted to examine the immediate after-effects of a cancer diagnosis in children, adolescents, and young adults.

Most importantly, now that these elevated risks have been identified, future research must address prevention strategies, they said.

This study was supported by the Swedish Council for Working Life and Social Research, the Swedish Research Council, Hjärnfonden, and Svenska Sällskapet för Medicinsk Forskning. No financial conflicts of interest were reported.

People who receive a cancer diagnosis are at markedly increased risk for suicide and for fatal cardiovascular events in the following weeks, according to a large Swedish cohort study reported in the April 5 issue of the New England Journal of Medicine.

"This spike in risk was particularly prominent among patients in whom cancers with a poor prognosis were diagnosed, and was not explained by preexisting psychiatric or cardiovascular conditions," said Dr. Fang Fang of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and her associates.

The dramatic increase in mortality risk from suicide or cardiovascular causes also cannot be attributed to cancer treatment or cancer progression, since it peaks during the first week after diagnosis and declined over time rather than increasing as treatment intensified or disease worsened, they noted.

Previous studies have demonstrated that cancer patients are at increased risk for suicide and CV events, but most have attributed it to "the burden of living with a progressing cancer." Very few have explored the period immediately following a cancer diagnosis, Dr. Fang and her colleagues said.

They examined this time period using data from a Swedish national registry of cancers and causes of death, both of which must be reported by law in Sweden. The study period, 1991 through 2006, covered more than 6 million Swedes aged 30 and older at baseline.

A total of 534,154 people received a first cancer diagnosis during this interval, including 95,786 with prostate cancer, 74,977 with breast cancer (among women), 62,719 with colorectal cancer, 47,169 with skin cancer, 36,648 with lymphatic or hematopoietic cancer, 34,743 with lung cancer, and 13,447 with CNS cancer. Another 26,335 patients were pooled in a single category of "highly fatal cancers of the esophagus, liver, and pancreas," and the remaining 142,330 patients had other types of cancer.

During follow-up, there were 786 completed suicides among patients with any type of cancer, for a rate of 0.36 per 1,000 person-years. This was double the rate among Swedish adults who did not have cancer: 13,284 completed suicides for a rate of 0.18 per 1,000 person-years (N. Engl. J. Med. 2012;366:1310-8).

The rate of completed suicides peaked during the first week after cancer diagnosis, at 2.50 per 1,000 person-years.

"We found a relative risk of 4.8 during the first 12 weeks after diagnosis (110 patients; incidence rate, 0.95 per 1,000 person-years), with the highest relative risk observed for highly fatal cancers of the esophagus, liver, or pancreas, followed by lung cancer," they added.

The magnitude of elevated risk dropped rapidly after that, but remained higher than average beyond the first year for all cancers.

"Focusing on the first 52 weeks after a diagnosis of any cancer, we found a relative risk of 3.1 for suicide (260 patients; incidence rate, 0.60 per 1,000 person-years). The expected number of suicides, adjusted for all demographic factors, during these 52 weeks was 87, leaving 173 cases associated with cancer diagnoses," the researchers said.

The relative risks of suicide were stronger among patients who had no concomitant psychiatric disorders than among those with psychiatric disorders.

Turning to fatal cardiovascular events, there were 48,991 CV deaths among people who received a diagnosis of any cancer, for an incidence of 23.10 per 1,000 person-years. This rate is approximately three times higher than that for people who did not have cancer (543,144 deaths; incidence rate, 7.53 per 1,000 person-years.

As with suicide, the highest relative risk of CV death (5.6) peaked during the first week after diagnosis (1,318 patients; incidence rate, 116.8 per 1,000 person-years). The risk elevation was highest for central nervous system cancers, followed by highly fatal cancers of the esophagus, liver, or pancreas, and then by lung cancer.

Also as with suicide, the magnitude of the increased risk of CV death dropped rapidly after the first several weeks. It did not persist beyond the first year after diagnosis.

"Focusing on the first 4 weeks after a diagnosis of any cancer but CNS tumors, we found a relative risk of 3.3 for cardiovascular death (2,641 patients; incidence rate, 65.81 per 1,000 person-years). The adjusted expected number of CV deaths was 766 during these 4 weeks, leaving 1,875 deaths associated with a cancer diagnosis," the investigators said.

Of note was the finding that the increased hazards were seen in both men and women.

To adjust for unmeasured confounders, the researchers performed an additional case-crossover analysis among all cancer patients in the cohort who died from suicide or CV causes. The results "further allayed the concern" that there may be some alternative explanation for the observed associations, such as an unknown factor that causes cancer, suicide, and CV death.

Dr. Fang and her associates emphasized that their study "focused on hard outcomes alone, and thus probably did not capture the full extent of the psychological burden among patients with newly diagnosed cancer. Other potentially relevant outcomes, such as attempted suicide and severe but nonfatal CV events, remain to be explored," they noted.

In addition, this study involved only adults aged 30 years and older. Further studies are warranted to examine the immediate after-effects of a cancer diagnosis in children, adolescents, and young adults.

Most importantly, now that these elevated risks have been identified, future research must address prevention strategies, they said.

This study was supported by the Swedish Council for Working Life and Social Research, the Swedish Research Council, Hjärnfonden, and Svenska Sällskapet för Medicinsk Forskning. No financial conflicts of interest were reported.

Taking oral fluoroquinolones appears to raise the risk that patients will develop a detached retina, according to a report in the April 4 issue of JAMA.

Fluoroquinolones have been linked to several forms of ocular toxicity, including corneal perforations, optic neuropathy, and retinal hemorrhages. "A class-wide warning also has been issued for tendon rupture, which raises concerns for the effect of these drugs on connective tissue in the eye," said Mahyar Etminan, Pharm.D., of the Child and Family Research Institute of British Columbia, Vancouver, and his associates.

In an epidemiologic case-control study examining a possible link between the drugs and retinal detachment, Dr. Etminan and his colleagues found that patients taking fluoroquinolones to treat an infection were nearly five times more likely to develop a detached retina than were nonusers.

They noted, however, that the absolute risk for the disorder remained small and estimated that 1,440 cases of retinal detachment diagnosed each year in the United States may be attributable to fluoroquinolone use.

The investigators studied the issue using information from a medical database covering approximately 4.5 million residents of British Columbia. They first identified all 989,591 patients who had visited an ophthalmologist in the province between 2000 and 2007, then identified all 4,384 incident cases of retinal detachment in that cohort.

Each case was matched for age with 10 control subjects from the cohort who did not have retinal detachment and all the subjects’ pharmacy records were searched for the use of ciprofloxacin, gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, or trovafloxacin for any indication except ocular infections in the preceding year. Such patients were excluded from the study because ocular infections themselves could raise the risk of retinal detachment.

The most common indications for fluoroquinolone use in this study were respiratory and genitourinary infections. Patients also took the drugs to treat gastrointestinal, skin, joint, bone, or other infections.

Patients currently using fluoroquinolones were found to be at significantly higher risk of developing a retinal detachment than were nonusers, with a rate ratio of 4.5, the investigators said (JAMA 2012;307:1414-9).

The mean length of the interval between the prescription of a fluoroquinolone and development of a retinal detachment was 4.8 days.

Patients who had used fluoroquinolones in the recent past (2 weeks before the index date) or the remote past (up to 1 year before the index date) showed no such increased risk. This indicates that the drugs’ adverse effect on the eye is acute.

Among the 445 fluoroquinolone users who developed retinal detachment, ciprofloxacin was the drug implicated in most cases (82.7%), followed by levofloxacin (7.2%), norfloxacin (4.9%), moxifloxacin (4.0%), and gatifloxacin (1.1%).

However, Dr. Etminan and his associates cautioned that the absolute risk of retinal detachment in fluoroquinolone users remained small at 4 per 10,000 person-years. They calculated that the number needed to harm was 2,500 patients.

"Given an approximate exposure prevalence of 10%, and assuming a similar risk increase in the general population, the population attributable risk would be estimated to be approximately 4%. We estimate that 1,440 cases of retinal detachment diagnosed annually in the United States may be attributed to oral fluoroquinolone use," they wrote.

"As a quality measure, we [also] tested the risk of retinal detachment in our study population with two distinct classes of medications that have not been associated with retinal detachment," namely oral beta-lactam antibiotics (penicillins and cephalosporins) and short-acting beta-agonists. No increase in risk for retinal detachment was found with either class of drugs.

"It is unlikely that treating retina surgeons suspected a possible link [between] oral fluoroquinolone use and retinal detachment, which may explain why more cases of retinal detachment secondary to fluoroquinolone use have not been reported," Dr. Etminan and his colleagues suggested.

The exact mechanism by which the drugs exert this adverse effect on the eye is not known, but it may involve their known ability to disrupt collagen and connective tissue. Medical conditions that are known to interfere with connective tissue and collagen formation "also increase vitreous liquefaction and have been shown to increase the risk of retinal detachment," the researchers said.

In addition, several large epidemiologic studies have demonstrated a link between fluoroquinolones and tendon rupture or detachment, usually within a median of 7 days of exposure to the drugs, which is similar to the 5-day interval noted in this study.

Further research is needed to confirm the association identified in this study, they added.

This study was funded by the Canadian National Institute for the Blind. No financial conflicts of interest were reported.

Taking oral fluoroquinolones appears to raise the risk that patients will develop a detached retina, according to a report in the April 4 issue of JAMA.

Fluoroquinolones have been linked to several forms of ocular toxicity, including corneal perforations, optic neuropathy, and retinal hemorrhages. "A class-wide warning also has been issued for tendon rupture, which raises concerns for the effect of these drugs on connective tissue in the eye," said Mahyar Etminan, Pharm.D., of the Child and Family Research Institute of British Columbia, Vancouver, and his associates.

In an epidemiologic case-control study examining a possible link between the drugs and retinal detachment, Dr. Etminan and his colleagues found that patients taking fluoroquinolones to treat an infection were nearly five times more likely to develop a detached retina than were nonusers.

They noted, however, that the absolute risk for the disorder remained small and estimated that 1,440 cases of retinal detachment diagnosed each year in the United States may be attributable to fluoroquinolone use.

The investigators studied the issue using information from a medical database covering approximately 4.5 million residents of British Columbia. They first identified all 989,591 patients who had visited an ophthalmologist in the province between 2000 and 2007, then identified all 4,384 incident cases of retinal detachment in that cohort.

Each case was matched for age with 10 control subjects from the cohort who did not have retinal detachment and all the subjects’ pharmacy records were searched for the use of ciprofloxacin, gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, or trovafloxacin for any indication except ocular infections in the preceding year. Such patients were excluded from the study because ocular infections themselves could raise the risk of retinal detachment.

The most common indications for fluoroquinolone use in this study were respiratory and genitourinary infections. Patients also took the drugs to treat gastrointestinal, skin, joint, bone, or other infections.

Patients currently using fluoroquinolones were found to be at significantly higher risk of developing a retinal detachment than were nonusers, with a rate ratio of 4.5, the investigators said (JAMA 2012;307:1414-9).

The mean length of the interval between the prescription of a fluoroquinolone and development of a retinal detachment was 4.8 days.

Patients who had used fluoroquinolones in the recent past (2 weeks before the index date) or the remote past (up to 1 year before the index date) showed no such increased risk. This indicates that the drugs’ adverse effect on the eye is acute.

Among the 445 fluoroquinolone users who developed retinal detachment, ciprofloxacin was the drug implicated in most cases (82.7%), followed by levofloxacin (7.2%), norfloxacin (4.9%), moxifloxacin (4.0%), and gatifloxacin (1.1%).

However, Dr. Etminan and his associates cautioned that the absolute risk of retinal detachment in fluoroquinolone users remained small at 4 per 10,000 person-years. They calculated that the number needed to harm was 2,500 patients.

"Given an approximate exposure prevalence of 10%, and assuming a similar risk increase in the general population, the population attributable risk would be estimated to be approximately 4%. We estimate that 1,440 cases of retinal detachment diagnosed annually in the United States may be attributed to oral fluoroquinolone use," they wrote.

"As a quality measure, we [also] tested the risk of retinal detachment in our study population with two distinct classes of medications that have not been associated with retinal detachment," namely oral beta-lactam antibiotics (penicillins and cephalosporins) and short-acting beta-agonists. No increase in risk for retinal detachment was found with either class of drugs.

"It is unlikely that treating retina surgeons suspected a possible link [between] oral fluoroquinolone use and retinal detachment, which may explain why more cases of retinal detachment secondary to fluoroquinolone use have not been reported," Dr. Etminan and his colleagues suggested.

The exact mechanism by which the drugs exert this adverse effect on the eye is not known, but it may involve their known ability to disrupt collagen and connective tissue. Medical conditions that are known to interfere with connective tissue and collagen formation "also increase vitreous liquefaction and have been shown to increase the risk of retinal detachment," the researchers said.

In addition, several large epidemiologic studies have demonstrated a link between fluoroquinolones and tendon rupture or detachment, usually within a median of 7 days of exposure to the drugs, which is similar to the 5-day interval noted in this study.

Further research is needed to confirm the association identified in this study, they added.

This study was funded by the Canadian National Institute for the Blind. No financial conflicts of interest were reported.

Taking oral fluoroquinolones appears to raise the risk that patients will develop a detached retina, according to a report in the April 4 issue of JAMA.

Fluoroquinolones have been linked to several forms of ocular toxicity, including corneal perforations, optic neuropathy, and retinal hemorrhages. "A class-wide warning also has been issued for tendon rupture, which raises concerns for the effect of these drugs on connective tissue in the eye," said Mahyar Etminan, Pharm.D., of the Child and Family Research Institute of British Columbia, Vancouver, and his associates.

In an epidemiologic case-control study examining a possible link between the drugs and retinal detachment, Dr. Etminan and his colleagues found that patients taking fluoroquinolones to treat an infection were nearly five times more likely to develop a detached retina than were nonusers.

They noted, however, that the absolute risk for the disorder remained small and estimated that 1,440 cases of retinal detachment diagnosed each year in the United States may be attributable to fluoroquinolone use.

The investigators studied the issue using information from a medical database covering approximately 4.5 million residents of British Columbia. They first identified all 989,591 patients who had visited an ophthalmologist in the province between 2000 and 2007, then identified all 4,384 incident cases of retinal detachment in that cohort.

Each case was matched for age with 10 control subjects from the cohort who did not have retinal detachment and all the subjects’ pharmacy records were searched for the use of ciprofloxacin, gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, or trovafloxacin for any indication except ocular infections in the preceding year. Such patients were excluded from the study because ocular infections themselves could raise the risk of retinal detachment.

The most common indications for fluoroquinolone use in this study were respiratory and genitourinary infections. Patients also took the drugs to treat gastrointestinal, skin, joint, bone, or other infections.

Patients currently using fluoroquinolones were found to be at significantly higher risk of developing a retinal detachment than were nonusers, with a rate ratio of 4.5, the investigators said (JAMA 2012;307:1414-9).

The mean length of the interval between the prescription of a fluoroquinolone and development of a retinal detachment was 4.8 days.

Patients who had used fluoroquinolones in the recent past (2 weeks before the index date) or the remote past (up to 1 year before the index date) showed no such increased risk. This indicates that the drugs’ adverse effect on the eye is acute.

Among the 445 fluoroquinolone users who developed retinal detachment, ciprofloxacin was the drug implicated in most cases (82.7%), followed by levofloxacin (7.2%), norfloxacin (4.9%), moxifloxacin (4.0%), and gatifloxacin (1.1%).

However, Dr. Etminan and his associates cautioned that the absolute risk of retinal detachment in fluoroquinolone users remained small at 4 per 10,000 person-years. They calculated that the number needed to harm was 2,500 patients.

"Given an approximate exposure prevalence of 10%, and assuming a similar risk increase in the general population, the population attributable risk would be estimated to be approximately 4%. We estimate that 1,440 cases of retinal detachment diagnosed annually in the United States may be attributed to oral fluoroquinolone use," they wrote.

"As a quality measure, we [also] tested the risk of retinal detachment in our study population with two distinct classes of medications that have not been associated with retinal detachment," namely oral beta-lactam antibiotics (penicillins and cephalosporins) and short-acting beta-agonists. No increase in risk for retinal detachment was found with either class of drugs.

"It is unlikely that treating retina surgeons suspected a possible link [between] oral fluoroquinolone use and retinal detachment, which may explain why more cases of retinal detachment secondary to fluoroquinolone use have not been reported," Dr. Etminan and his colleagues suggested.

The exact mechanism by which the drugs exert this adverse effect on the eye is not known, but it may involve their known ability to disrupt collagen and connective tissue. Medical conditions that are known to interfere with connective tissue and collagen formation "also increase vitreous liquefaction and have been shown to increase the risk of retinal detachment," the researchers said.

In addition, several large epidemiologic studies have demonstrated a link between fluoroquinolones and tendon rupture or detachment, usually within a median of 7 days of exposure to the drugs, which is similar to the 5-day interval noted in this study.

Further research is needed to confirm the association identified in this study, they added.

This study was funded by the Canadian National Institute for the Blind. No financial conflicts of interest were reported.

Notable declines in both pneumonia hospitalizations and inpatient mortality attributed to pneumonia actually appear to be statistical artifacts related to changes in diagnostic coding rather than to bonafide improvements in health care, according to a report in the April 4 issue of JAMA.

A nationwide 27% reduction in pneumonia hospitalizations and an accompanying 28% reduction in pneumonia mortality were offset by concomitant rises in the rates of hospitalization and death due to sepsis (with a secondary diagnosis of pneumonia) and to respiratory failure (with a secondary diagnosis of pneumonia), said Dr. Peter K. Lindenauer of the Center for Quality of Care Research, Baystate Medical Center, Springfield, Mass., and his associates.

"These results suggest that secular trends in documentation and coding, rather than improvements in actual outcomes, may explain much of the observed change in this and other studies," they noted.

The findings also suggest that ratings of hospital performance based on pneumonia statistics may be inaccurate because of variation across hospitals in the use of diagnostic codes for pneumonia, sepsis, and respiratory failure, they added.

Noting that several epidemiologic studies have reported improvements in pneumonia statistics but that there haven’t been any "care-transforming technologies" to account for this improvement, Dr. Lindenauer and his colleagues analyzed trends in pneumonia hospital admissions and outcomes over time. They used data from the 2003 through the 2009 Nationwide Inpatient Sample (NIS), the largest all-payer hospital database in the country, which covers between 5 million and 8 million discharges each year. The NIS is sponsored by the U.S. Agency for Healthcare Research and Quality.

The researchers assessed hospitalizations for a principal diagnosis of pneumonia, as well as for a principal diagnosis of sepsis or respiratory failure together with a secondary diagnosis of pneumonia. For control conditions, they assessed hospitalizations for a principal diagnosis of ischemic stroke, ST-segment-elevation myocardial infarction (STEMI), and ruptured thoracic or abdominal aortic aneurysms.

"We also considered change over time in discharge disposition, including discharge to hospice, as a secondary outcome because increasing referral to inpatient nursing and rehabilitation facilities and hospice might allow sicker patients to be discharged rather than retained in the hospital," they noted.

From 2003 to 2009, the hospitalization rate of patients with a principal diagnosis of pneumonia decreased by 27.4%, from 5.5 per 1,000 to 4.0 per 1,000. This reversed "a well-documented decades-long trend toward increasing hospitalization" for the disorder, the investigators said (JAMA 2012;307:1405-13).

During the same period, however, the hospitalization rate for patients with a principal diagnosis of sepsis and a secondary diagnosis of pneumonia rose 177.6%, from 0.4 per 1,000 to 1.1 per 1,000. And the hospitalization rate for patients with a principal diagnosis of respiratory failure and a secondary diagnosis of pneumonia rose 9.3%, from 0.44 per 1,000 to 0.48 per 1,000.

These trends were consistent across all age groups and for both men and women.

During the same period, inpatient pneumonia mortality declined from 5.8% to 4.2%, a relative risk reduction (RRR) of 28.2%. There was a concomitant decline in inpatient sepsis mortality (RRR, 12%) and in inpatient respiratory failure mortality (RRR, 23.7%).

However, "when the three groups were combined ... there was little change in the inpatient mortality rate, varying from a small increase to a small decline, depending on the approach to risk adjustment," Dr. Lindenauer and his associates said.

As expected, the reductions in inpatient hospitalizations for the three control conditions were significantly smaller than those for pneumonia hospitalizations. Ischemic stroke, STEMI, and ruptured aortic aneurysms were indeed "less susceptible to secular changes in the choice of an alternative principal diagnosis," they pointed out.

Also as expected, the proportion of pneumonia patients discharged to nursing facilities and hospices did not account for the large decline in pneumonia inpatients.

The results of the primary analysis in this study were supported by those of a secondary analysis of bacteriologic types. Hospitalization rates for pneumococcal, pseudomonas, and staphylococcal pneumonias all declined to a similar extent as overall pneumonia and were offset by matching rises in the rates of sepsis due to these organisms.

The study findings have important implications well beyond the scope of pneumonia. "Several recent studies have reported very rapid growth in the rate of hospitalizations of patients with sepsis and severe sepsis, suggesting that the phenomenon in this study" may extend to many other infectious diseases, the investigators said.

Turning to the question of why clinicians might be switching from a principal diagnosis of pneumonia to a principal diagnosis of sepsis/secondary diagnosis of pneumonia, Dr. Lindenauer and his colleagues offered two possible explanations.

First, there was a well-publicized national campaign advocating the early recognition and treatment of sepsis in 2002. Second, hospital reimbursement rates for sepsis and respiratory failure are higher than those for pneumonia, they noted.

No conflicts of interest were reported.

Notable declines in both pneumonia hospitalizations and inpatient mortality attributed to pneumonia actually appear to be statistical artifacts related to changes in diagnostic coding rather than to bonafide improvements in health care, according to a report in the April 4 issue of JAMA.

A nationwide 27% reduction in pneumonia hospitalizations and an accompanying 28% reduction in pneumonia mortality were offset by concomitant rises in the rates of hospitalization and death due to sepsis (with a secondary diagnosis of pneumonia) and to respiratory failure (with a secondary diagnosis of pneumonia), said Dr. Peter K. Lindenauer of the Center for Quality of Care Research, Baystate Medical Center, Springfield, Mass., and his associates.

"These results suggest that secular trends in documentation and coding, rather than improvements in actual outcomes, may explain much of the observed change in this and other studies," they noted.

The findings also suggest that ratings of hospital performance based on pneumonia statistics may be inaccurate because of variation across hospitals in the use of diagnostic codes for pneumonia, sepsis, and respiratory failure, they added.

Noting that several epidemiologic studies have reported improvements in pneumonia statistics but that there haven’t been any "care-transforming technologies" to account for this improvement, Dr. Lindenauer and his colleagues analyzed trends in pneumonia hospital admissions and outcomes over time. They used data from the 2003 through the 2009 Nationwide Inpatient Sample (NIS), the largest all-payer hospital database in the country, which covers between 5 million and 8 million discharges each year. The NIS is sponsored by the U.S. Agency for Healthcare Research and Quality.

The researchers assessed hospitalizations for a principal diagnosis of pneumonia, as well as for a principal diagnosis of sepsis or respiratory failure together with a secondary diagnosis of pneumonia. For control conditions, they assessed hospitalizations for a principal diagnosis of ischemic stroke, ST-segment-elevation myocardial infarction (STEMI), and ruptured thoracic or abdominal aortic aneurysms.

"We also considered change over time in discharge disposition, including discharge to hospice, as a secondary outcome because increasing referral to inpatient nursing and rehabilitation facilities and hospice might allow sicker patients to be discharged rather than retained in the hospital," they noted.

From 2003 to 2009, the hospitalization rate of patients with a principal diagnosis of pneumonia decreased by 27.4%, from 5.5 per 1,000 to 4.0 per 1,000. This reversed "a well-documented decades-long trend toward increasing hospitalization" for the disorder, the investigators said (JAMA 2012;307:1405-13).

During the same period, however, the hospitalization rate for patients with a principal diagnosis of sepsis and a secondary diagnosis of pneumonia rose 177.6%, from 0.4 per 1,000 to 1.1 per 1,000. And the hospitalization rate for patients with a principal diagnosis of respiratory failure and a secondary diagnosis of pneumonia rose 9.3%, from 0.44 per 1,000 to 0.48 per 1,000.

These trends were consistent across all age groups and for both men and women.

During the same period, inpatient pneumonia mortality declined from 5.8% to 4.2%, a relative risk reduction (RRR) of 28.2%. There was a concomitant decline in inpatient sepsis mortality (RRR, 12%) and in inpatient respiratory failure mortality (RRR, 23.7%).

However, "when the three groups were combined ... there was little change in the inpatient mortality rate, varying from a small increase to a small decline, depending on the approach to risk adjustment," Dr. Lindenauer and his associates said.

As expected, the reductions in inpatient hospitalizations for the three control conditions were significantly smaller than those for pneumonia hospitalizations. Ischemic stroke, STEMI, and ruptured aortic aneurysms were indeed "less susceptible to secular changes in the choice of an alternative principal diagnosis," they pointed out.

Also as expected, the proportion of pneumonia patients discharged to nursing facilities and hospices did not account for the large decline in pneumonia inpatients.

The results of the primary analysis in this study were supported by those of a secondary analysis of bacteriologic types. Hospitalization rates for pneumococcal, pseudomonas, and staphylococcal pneumonias all declined to a similar extent as overall pneumonia and were offset by matching rises in the rates of sepsis due to these organisms.

The study findings have important implications well beyond the scope of pneumonia. "Several recent studies have reported very rapid growth in the rate of hospitalizations of patients with sepsis and severe sepsis, suggesting that the phenomenon in this study" may extend to many other infectious diseases, the investigators said.

Turning to the question of why clinicians might be switching from a principal diagnosis of pneumonia to a principal diagnosis of sepsis/secondary diagnosis of pneumonia, Dr. Lindenauer and his colleagues offered two possible explanations.

First, there was a well-publicized national campaign advocating the early recognition and treatment of sepsis in 2002. Second, hospital reimbursement rates for sepsis and respiratory failure are higher than those for pneumonia, they noted.

No conflicts of interest were reported.

Notable declines in both pneumonia hospitalizations and inpatient mortality attributed to pneumonia actually appear to be statistical artifacts related to changes in diagnostic coding rather than to bonafide improvements in health care, according to a report in the April 4 issue of JAMA.

A nationwide 27% reduction in pneumonia hospitalizations and an accompanying 28% reduction in pneumonia mortality were offset by concomitant rises in the rates of hospitalization and death due to sepsis (with a secondary diagnosis of pneumonia) and to respiratory failure (with a secondary diagnosis of pneumonia), said Dr. Peter K. Lindenauer of the Center for Quality of Care Research, Baystate Medical Center, Springfield, Mass., and his associates.

"These results suggest that secular trends in documentation and coding, rather than improvements in actual outcomes, may explain much of the observed change in this and other studies," they noted.

The findings also suggest that ratings of hospital performance based on pneumonia statistics may be inaccurate because of variation across hospitals in the use of diagnostic codes for pneumonia, sepsis, and respiratory failure, they added.

Noting that several epidemiologic studies have reported improvements in pneumonia statistics but that there haven’t been any "care-transforming technologies" to account for this improvement, Dr. Lindenauer and his colleagues analyzed trends in pneumonia hospital admissions and outcomes over time. They used data from the 2003 through the 2009 Nationwide Inpatient Sample (NIS), the largest all-payer hospital database in the country, which covers between 5 million and 8 million discharges each year. The NIS is sponsored by the U.S. Agency for Healthcare Research and Quality.

The researchers assessed hospitalizations for a principal diagnosis of pneumonia, as well as for a principal diagnosis of sepsis or respiratory failure together with a secondary diagnosis of pneumonia. For control conditions, they assessed hospitalizations for a principal diagnosis of ischemic stroke, ST-segment-elevation myocardial infarction (STEMI), and ruptured thoracic or abdominal aortic aneurysms.

"We also considered change over time in discharge disposition, including discharge to hospice, as a secondary outcome because increasing referral to inpatient nursing and rehabilitation facilities and hospice might allow sicker patients to be discharged rather than retained in the hospital," they noted.

From 2003 to 2009, the hospitalization rate of patients with a principal diagnosis of pneumonia decreased by 27.4%, from 5.5 per 1,000 to 4.0 per 1,000. This reversed "a well-documented decades-long trend toward increasing hospitalization" for the disorder, the investigators said (JAMA 2012;307:1405-13).

During the same period, however, the hospitalization rate for patients with a principal diagnosis of sepsis and a secondary diagnosis of pneumonia rose 177.6%, from 0.4 per 1,000 to 1.1 per 1,000. And the hospitalization rate for patients with a principal diagnosis of respiratory failure and a secondary diagnosis of pneumonia rose 9.3%, from 0.44 per 1,000 to 0.48 per 1,000.

These trends were consistent across all age groups and for both men and women.

During the same period, inpatient pneumonia mortality declined from 5.8% to 4.2%, a relative risk reduction (RRR) of 28.2%. There was a concomitant decline in inpatient sepsis mortality (RRR, 12%) and in inpatient respiratory failure mortality (RRR, 23.7%).

However, "when the three groups were combined ... there was little change in the inpatient mortality rate, varying from a small increase to a small decline, depending on the approach to risk adjustment," Dr. Lindenauer and his associates said.

As expected, the reductions in inpatient hospitalizations for the three control conditions were significantly smaller than those for pneumonia hospitalizations. Ischemic stroke, STEMI, and ruptured aortic aneurysms were indeed "less susceptible to secular changes in the choice of an alternative principal diagnosis," they pointed out.

Also as expected, the proportion of pneumonia patients discharged to nursing facilities and hospices did not account for the large decline in pneumonia inpatients.

The results of the primary analysis in this study were supported by those of a secondary analysis of bacteriologic types. Hospitalization rates for pneumococcal, pseudomonas, and staphylococcal pneumonias all declined to a similar extent as overall pneumonia and were offset by matching rises in the rates of sepsis due to these organisms.

The study findings have important implications well beyond the scope of pneumonia. "Several recent studies have reported very rapid growth in the rate of hospitalizations of patients with sepsis and severe sepsis, suggesting that the phenomenon in this study" may extend to many other infectious diseases, the investigators said.

Turning to the question of why clinicians might be switching from a principal diagnosis of pneumonia to a principal diagnosis of sepsis/secondary diagnosis of pneumonia, Dr. Lindenauer and his colleagues offered two possible explanations.

First, there was a well-publicized national campaign advocating the early recognition and treatment of sepsis in 2002. Second, hospital reimbursement rates for sepsis and respiratory failure are higher than those for pneumonia, they noted.

No conflicts of interest were reported.

The introduction of widespread screening mammography in Norway was associated with an estimated 15%-25% "overdiagnosis" of breast cancer there, according to a report in the April 3 issue of the Annals of Internal Medicine.

This finding is consistent with those of previous studies in other countries, which estimated rates of overdiagnosis ranging from 0% to 54%, with randomized controlled trials tending to estimate it at approximately 30%, investigators said.

The result of this study in Norway adds to the evidence that "overdiagnosis and unnecessary treatment of nonfatal cancer creates a substantial ethical and clinical dilemma and may cast doubt on whether mammography screening programs should exist," said Dr. Mette Kalager of the department of epidemiology, Harvard School of Public Health, Boston, and her associates.

Screening mammography was uncommon in Norway until a national, state-funded program began in 1996. Screening mammography was then implemented gradually, in different geographic areas, over the course of 10 years. Since 2005, all women in Norway aged 50-69 years have been invited to participate in mammographic screening every 2 years, and approximately 77% of them do so.

"This staggered implementation allowed comparison of contemporaneous trends in breast cancer incidence in areas with and without mammography screening," as well as the comparison of current and historical trends in incidence. This in turn gave the researchers two analytic methods for calculating estimates of overdiagnosis.

They defined overdiagnosis as the percentage of cases of cancer that would not have become clinically apparent in a woman’s lifetime without screening. It refers to cases of breast cancer that would be diagnosed and treated without yielding any possible survival benefit – cases in which the tumor would never have progressed to a clinical stage or in which the woman would die from other causes before the breast cancer became evident.

The study population comprised 39,888 women diagnosed as having invasive breast cancer in 1996-2005, including 27,238 who were aged 50-79 years at diagnosis. A total of 7,793 women were diagnosed after the introduction of routine screening.

In fully adjusted analyses using the first method of estimating, 15%-20% of the cases of breast cancer found on screening mammography – that is, between 1,169 and 1,948 women – were overdiagnosed. In an analysis using the second method of estimating, 18%-25% of cases were overdiagnosed.

Thus, the overall rate of overdiagnosis in this study was 15%-25%, Dr. Kalager and her colleagues said (Ann. Intern. Med. 2012;156:491-9).

Moreover, the proportion of advanced-stage breast cancers decreased over time to the same degree among screened and unscreened women, while the proportion of stage I breast cancers markedly increased only among screened women. This indicates that the cancers being found on screening mammography were almost entirely early-stage, low-risk tumors.

"Our findings suggest that enhanced awareness is probably the reason for the reduction of late-stage cancer, not screening," the investigators noted.

Extrapolating their findings, they added that "after 10 years of biennial mammography screening, for every 2,500 women invited, 6-10 women have been overdiagnosed, 20 women are diagnosed with breast cancer ... and one death from breast cancer has been prevented.

"To put it differently, if 2,500 women are invited to undergo mammography screening over 10 years, 2,470-2,474 women will not be diagnosed with breast cancer, 2,499 will not die of breast cancer, but 6-10 women will be overdiagnosed," they said.

This study was supported by the Research Council of Norway and Frontier Science. Dr. Kalager and her coauthors had no relevant disclosures.

The introduction of widespread screening mammography in Norway was associated with an estimated 15%-25% "overdiagnosis" of breast cancer there, according to a report in the April 3 issue of the Annals of Internal Medicine.

This finding is consistent with those of previous studies in other countries, which estimated rates of overdiagnosis ranging from 0% to 54%, with randomized controlled trials tending to estimate it at approximately 30%, investigators said.

The result of this study in Norway adds to the evidence that "overdiagnosis and unnecessary treatment of nonfatal cancer creates a substantial ethical and clinical dilemma and may cast doubt on whether mammography screening programs should exist," said Dr. Mette Kalager of the department of epidemiology, Harvard School of Public Health, Boston, and her associates.

Screening mammography was uncommon in Norway until a national, state-funded program began in 1996. Screening mammography was then implemented gradually, in different geographic areas, over the course of 10 years. Since 2005, all women in Norway aged 50-69 years have been invited to participate in mammographic screening every 2 years, and approximately 77% of them do so.

"This staggered implementation allowed comparison of contemporaneous trends in breast cancer incidence in areas with and without mammography screening," as well as the comparison of current and historical trends in incidence. This in turn gave the researchers two analytic methods for calculating estimates of overdiagnosis.

They defined overdiagnosis as the percentage of cases of cancer that would not have become clinically apparent in a woman’s lifetime without screening. It refers to cases of breast cancer that would be diagnosed and treated without yielding any possible survival benefit – cases in which the tumor would never have progressed to a clinical stage or in which the woman would die from other causes before the breast cancer became evident.

The study population comprised 39,888 women diagnosed as having invasive breast cancer in 1996-2005, including 27,238 who were aged 50-79 years at diagnosis. A total of 7,793 women were diagnosed after the introduction of routine screening.

In fully adjusted analyses using the first method of estimating, 15%-20% of the cases of breast cancer found on screening mammography – that is, between 1,169 and 1,948 women – were overdiagnosed. In an analysis using the second method of estimating, 18%-25% of cases were overdiagnosed.

Thus, the overall rate of overdiagnosis in this study was 15%-25%, Dr. Kalager and her colleagues said (Ann. Intern. Med. 2012;156:491-9).

Moreover, the proportion of advanced-stage breast cancers decreased over time to the same degree among screened and unscreened women, while the proportion of stage I breast cancers markedly increased only among screened women. This indicates that the cancers being found on screening mammography were almost entirely early-stage, low-risk tumors.

"Our findings suggest that enhanced awareness is probably the reason for the reduction of late-stage cancer, not screening," the investigators noted.

Extrapolating their findings, they added that "after 10 years of biennial mammography screening, for every 2,500 women invited, 6-10 women have been overdiagnosed, 20 women are diagnosed with breast cancer ... and one death from breast cancer has been prevented.

"To put it differently, if 2,500 women are invited to undergo mammography screening over 10 years, 2,470-2,474 women will not be diagnosed with breast cancer, 2,499 will not die of breast cancer, but 6-10 women will be overdiagnosed," they said.

This study was supported by the Research Council of Norway and Frontier Science. Dr. Kalager and her coauthors had no relevant disclosures.

The introduction of widespread screening mammography in Norway was associated with an estimated 15%-25% "overdiagnosis" of breast cancer there, according to a report in the April 3 issue of the Annals of Internal Medicine.

This finding is consistent with those of previous studies in other countries, which estimated rates of overdiagnosis ranging from 0% to 54%, with randomized controlled trials tending to estimate it at approximately 30%, investigators said.

The result of this study in Norway adds to the evidence that "overdiagnosis and unnecessary treatment of nonfatal cancer creates a substantial ethical and clinical dilemma and may cast doubt on whether mammography screening programs should exist," said Dr. Mette Kalager of the department of epidemiology, Harvard School of Public Health, Boston, and her associates.

Screening mammography was uncommon in Norway until a national, state-funded program began in 1996. Screening mammography was then implemented gradually, in different geographic areas, over the course of 10 years. Since 2005, all women in Norway aged 50-69 years have been invited to participate in mammographic screening every 2 years, and approximately 77% of them do so.

"This staggered implementation allowed comparison of contemporaneous trends in breast cancer incidence in areas with and without mammography screening," as well as the comparison of current and historical trends in incidence. This in turn gave the researchers two analytic methods for calculating estimates of overdiagnosis.

They defined overdiagnosis as the percentage of cases of cancer that would not have become clinically apparent in a woman’s lifetime without screening. It refers to cases of breast cancer that would be diagnosed and treated without yielding any possible survival benefit – cases in which the tumor would never have progressed to a clinical stage or in which the woman would die from other causes before the breast cancer became evident.

The study population comprised 39,888 women diagnosed as having invasive breast cancer in 1996-2005, including 27,238 who were aged 50-79 years at diagnosis. A total of 7,793 women were diagnosed after the introduction of routine screening.

In fully adjusted analyses using the first method of estimating, 15%-20% of the cases of breast cancer found on screening mammography – that is, between 1,169 and 1,948 women – were overdiagnosed. In an analysis using the second method of estimating, 18%-25% of cases were overdiagnosed.

Thus, the overall rate of overdiagnosis in this study was 15%-25%, Dr. Kalager and her colleagues said (Ann. Intern. Med. 2012;156:491-9).

Moreover, the proportion of advanced-stage breast cancers decreased over time to the same degree among screened and unscreened women, while the proportion of stage I breast cancers markedly increased only among screened women. This indicates that the cancers being found on screening mammography were almost entirely early-stage, low-risk tumors.

"Our findings suggest that enhanced awareness is probably the reason for the reduction of late-stage cancer, not screening," the investigators noted.

Extrapolating their findings, they added that "after 10 years of biennial mammography screening, for every 2,500 women invited, 6-10 women have been overdiagnosed, 20 women are diagnosed with breast cancer ... and one death from breast cancer has been prevented.

"To put it differently, if 2,500 women are invited to undergo mammography screening over 10 years, 2,470-2,474 women will not be diagnosed with breast cancer, 2,499 will not die of breast cancer, but 6-10 women will be overdiagnosed," they said.

This study was supported by the Research Council of Norway and Frontier Science. Dr. Kalager and her coauthors had no relevant disclosures.

Chemotherapy doses should be tailored for obese cancer patients based on their actual body weight, not their ideal body weight, according to a new practice guideline from the American Society of Clinical Oncology.

There is no evidence that full-weight-based chemotherapy doses cause greater toxicity than adjusted doses, and concerns about "overdosing" obese cancer patients are unfounded, a panel of experts wrote in a report published online April 2 in the Journal of Clinical Oncology.

A systematic review of the literature showed that many overweight and obese cancer patients continue to receive underdoses of intravenous and oral cytotoxic drugs because of "considerable uncertainty among physicians about optimal dose selection," even though research has confirmed that full-weight-based dosing is both safe and crucial to the patients’ survival.

"Many oncologists continue to use either ideal body weight or adjusted ideal body weight, or to cap the body surface area at, for example, 2.0 m², rather than use actual body weight to calculate body surface area," said Dr. Jennifer J. Griggs of the University of Michigan, Ann Arbor, and her associates on the expert panel for ASCO’s new practice guideline.

As a result, chemotherapy dosing varies widely in overweight and obese patients, with as many as 40% receiving less than optimal dosing. This "may explain, in part, the significantly higher cancer mortality observed in overweight and obese individuals," they noted.

"With the incidence of obesity at an all-time high in the United States, as well as in other developed and developing nations, oncologists face this issue more than ever before," Dr. Griggs added in a press statement accompanying release of the guideline.

The ASCO guideline panel reviewed all the randomized clinical trials, meta-analyses, and clinical practice guidelines of other organizations concerning cytotoxic oral or IV chemotherapy dosing approaches for overweight or obese patients with cancer, excluding leukemias. Since there have been no prospective randomized studies directly comparing full-weight-based dose selection against other types of dose selection, they had to rely primarily on subgroup analyses and registry data.

Most of the studies concerned breast, ovarian, colon, and lung cancers, the authors said. As little data in the literature addressed dosing for novel agents such as tyrosine kinase inhibitors, immunotherapies such as interleukin-2 or interferon, or monoclonal antibodies, the guideline did not address these agents.

A summary of the guideline (J. Clin. Oncol. 2012 [doi:10.1200/JCO.2011.39.9436]) lists these key recommendations:

• Actual body weight should be used to select cytotoxic chemotherapy doses, regardless of obesity status. There is no evidence that either short- or long-term toxicity is increased with this approach.

• Use the same strategy in obese patients as in other patients for dose reductions, taking into account the type and severity of toxicity, any comorbid conditions, and whether the aim of treatment is cure or palliation. There is no evidence that greater dose reductions are needed for obese patients. Also, consider resuming the full-weight-based dose for subsequent chemotherapy cycles, especially if a possible cause of toxicity (such as impaired renal or liver function) has resolved.

• Consider fixed dosing only with select cytotoxic agents for which maximal dosing limits have been established, such as vincristine, carboplatin, or bleomycin.

• Calculate body surface area using any of the standard formulas currently available. There is no evidence to support using one formula over any other.

• Further research is needed into the pharmacokinetics and pharmacogenetics of chemotherapy dosing for obese patients, who have been excluded from many anticancer drug trials.

The guideline also emphasizes that physicians may need to fully discuss this issue with patients and caregivers, stressing that higher doses are needed in obese patients for the chemotherapy to be effective and reassuring them that toxicity is not expected to be any greater at proportionally higher doses.

"Communication with other health care providers is also warranted. Pharmacists and nursing professionals who are accustomed to limiting chemotherapy doses for obese patients should be informed of the existing evidence. IV and oral doses may be prepackaged for patients of normal weight, but appropriate dosing should be delivered, regardless of doses contained within a given vial. Arbitrary capping based on drug procurement is unacceptable (e.g., 1 vs. 1.5 vials)," the guideline stated.

Clinicians also should be aware that since rates of obesity are higher in black patients, Hispanic patients, and patients of lower socioeconomic status, these groups are harmed the most by underdosing and may benefit the most when full-weight-based dosing is adopted.

"This guideline should ease fears about administering chemotherapy based on actual body weight to otherwise healthy obese patients with cancer," Dr. Gary H. Lyman, cochair of the expert panel that drafted the guideline, said in a press statement.

"While chemotherapy dose for an obese patient may be larger than some physicians are accustomed to, they can rest assured that the risk of toxicity associated with chemotherapy dosing based on actual body weight is no greater in obese patients than in nonobese patients with cancer," said Dr. Lyman, a professor of medicine in the division of medical oncology at Duke University, Durham, N.C.

The full practice guideline, along with additional information on methodology and clinical resources, is available at ASCO’s website. For additional patient information, click here.

No financial conflicts of interest were reported.

Chemotherapy doses should be tailored for obese cancer patients based on their actual body weight, not their ideal body weight, according to a new practice guideline from the American Society of Clinical Oncology.

There is no evidence that full-weight-based chemotherapy doses cause greater toxicity than adjusted doses, and concerns about "overdosing" obese cancer patients are unfounded, a panel of experts wrote in a report published online April 2 in the Journal of Clinical Oncology.

A systematic review of the literature showed that many overweight and obese cancer patients continue to receive underdoses of intravenous and oral cytotoxic drugs because of "considerable uncertainty among physicians about optimal dose selection," even though research has confirmed that full-weight-based dosing is both safe and crucial to the patients’ survival.

"Many oncologists continue to use either ideal body weight or adjusted ideal body weight, or to cap the body surface area at, for example, 2.0 m², rather than use actual body weight to calculate body surface area," said Dr. Jennifer J. Griggs of the University of Michigan, Ann Arbor, and her associates on the expert panel for ASCO’s new practice guideline.

As a result, chemotherapy dosing varies widely in overweight and obese patients, with as many as 40% receiving less than optimal dosing. This "may explain, in part, the significantly higher cancer mortality observed in overweight and obese individuals," they noted.

"With the incidence of obesity at an all-time high in the United States, as well as in other developed and developing nations, oncologists face this issue more than ever before," Dr. Griggs added in a press statement accompanying release of the guideline.

The ASCO guideline panel reviewed all the randomized clinical trials, meta-analyses, and clinical practice guidelines of other organizations concerning cytotoxic oral or IV chemotherapy dosing approaches for overweight or obese patients with cancer, excluding leukemias. Since there have been no prospective randomized studies directly comparing full-weight-based dose selection against other types of dose selection, they had to rely primarily on subgroup analyses and registry data.

Most of the studies concerned breast, ovarian, colon, and lung cancers, the authors said. As little data in the literature addressed dosing for novel agents such as tyrosine kinase inhibitors, immunotherapies such as interleukin-2 or interferon, or monoclonal antibodies, the guideline did not address these agents.

A summary of the guideline (J. Clin. Oncol. 2012 [doi:10.1200/JCO.2011.39.9436]) lists these key recommendations:

• Actual body weight should be used to select cytotoxic chemotherapy doses, regardless of obesity status. There is no evidence that either short- or long-term toxicity is increased with this approach.

• Use the same strategy in obese patients as in other patients for dose reductions, taking into account the type and severity of toxicity, any comorbid conditions, and whether the aim of treatment is cure or palliation. There is no evidence that greater dose reductions are needed for obese patients. Also, consider resuming the full-weight-based dose for subsequent chemotherapy cycles, especially if a possible cause of toxicity (such as impaired renal or liver function) has resolved.

• Consider fixed dosing only with select cytotoxic agents for which maximal dosing limits have been established, such as vincristine, carboplatin, or bleomycin.

• Calculate body surface area using any of the standard formulas currently available. There is no evidence to support using one formula over any other.

• Further research is needed into the pharmacokinetics and pharmacogenetics of chemotherapy dosing for obese patients, who have been excluded from many anticancer drug trials.

The guideline also emphasizes that physicians may need to fully discuss this issue with patients and caregivers, stressing that higher doses are needed in obese patients for the chemotherapy to be effective and reassuring them that toxicity is not expected to be any greater at proportionally higher doses.

"Communication with other health care providers is also warranted. Pharmacists and nursing professionals who are accustomed to limiting chemotherapy doses for obese patients should be informed of the existing evidence. IV and oral doses may be prepackaged for patients of normal weight, but appropriate dosing should be delivered, regardless of doses contained within a given vial. Arbitrary capping based on drug procurement is unacceptable (e.g., 1 vs. 1.5 vials)," the guideline stated.

Clinicians also should be aware that since rates of obesity are higher in black patients, Hispanic patients, and patients of lower socioeconomic status, these groups are harmed the most by underdosing and may benefit the most when full-weight-based dosing is adopted.

"This guideline should ease fears about administering chemotherapy based on actual body weight to otherwise healthy obese patients with cancer," Dr. Gary H. Lyman, cochair of the expert panel that drafted the guideline, said in a press statement.

"While chemotherapy dose for an obese patient may be larger than some physicians are accustomed to, they can rest assured that the risk of toxicity associated with chemotherapy dosing based on actual body weight is no greater in obese patients than in nonobese patients with cancer," said Dr. Lyman, a professor of medicine in the division of medical oncology at Duke University, Durham, N.C.

The full practice guideline, along with additional information on methodology and clinical resources, is available at ASCO’s website. For additional patient information, click here.

No financial conflicts of interest were reported.

Chemotherapy doses should be tailored for obese cancer patients based on their actual body weight, not their ideal body weight, according to a new practice guideline from the American Society of Clinical Oncology.

There is no evidence that full-weight-based chemotherapy doses cause greater toxicity than adjusted doses, and concerns about "overdosing" obese cancer patients are unfounded, a panel of experts wrote in a report published online April 2 in the Journal of Clinical Oncology.

A systematic review of the literature showed that many overweight and obese cancer patients continue to receive underdoses of intravenous and oral cytotoxic drugs because of "considerable uncertainty among physicians about optimal dose selection," even though research has confirmed that full-weight-based dosing is both safe and crucial to the patients’ survival.

"Many oncologists continue to use either ideal body weight or adjusted ideal body weight, or to cap the body surface area at, for example, 2.0 m², rather than use actual body weight to calculate body surface area," said Dr. Jennifer J. Griggs of the University of Michigan, Ann Arbor, and her associates on the expert panel for ASCO’s new practice guideline.

As a result, chemotherapy dosing varies widely in overweight and obese patients, with as many as 40% receiving less than optimal dosing. This "may explain, in part, the significantly higher cancer mortality observed in overweight and obese individuals," they noted.

"With the incidence of obesity at an all-time high in the United States, as well as in other developed and developing nations, oncologists face this issue more than ever before," Dr. Griggs added in a press statement accompanying release of the guideline.

The ASCO guideline panel reviewed all the randomized clinical trials, meta-analyses, and clinical practice guidelines of other organizations concerning cytotoxic oral or IV chemotherapy dosing approaches for overweight or obese patients with cancer, excluding leukemias. Since there have been no prospective randomized studies directly comparing full-weight-based dose selection against other types of dose selection, they had to rely primarily on subgroup analyses and registry data.

Most of the studies concerned breast, ovarian, colon, and lung cancers, the authors said. As little data in the literature addressed dosing for novel agents such as tyrosine kinase inhibitors, immunotherapies such as interleukin-2 or interferon, or monoclonal antibodies, the guideline did not address these agents.

A summary of the guideline (J. Clin. Oncol. 2012 [doi:10.1200/JCO.2011.39.9436]) lists these key recommendations:

• Actual body weight should be used to select cytotoxic chemotherapy doses, regardless of obesity status. There is no evidence that either short- or long-term toxicity is increased with this approach.

• Use the same strategy in obese patients as in other patients for dose reductions, taking into account the type and severity of toxicity, any comorbid conditions, and whether the aim of treatment is cure or palliation. There is no evidence that greater dose reductions are needed for obese patients. Also, consider resuming the full-weight-based dose for subsequent chemotherapy cycles, especially if a possible cause of toxicity (such as impaired renal or liver function) has resolved.

• Consider fixed dosing only with select cytotoxic agents for which maximal dosing limits have been established, such as vincristine, carboplatin, or bleomycin.

• Calculate body surface area using any of the standard formulas currently available. There is no evidence to support using one formula over any other.

• Further research is needed into the pharmacokinetics and pharmacogenetics of chemotherapy dosing for obese patients, who have been excluded from many anticancer drug trials.

The guideline also emphasizes that physicians may need to fully discuss this issue with patients and caregivers, stressing that higher doses are needed in obese patients for the chemotherapy to be effective and reassuring them that toxicity is not expected to be any greater at proportionally higher doses.

"Communication with other health care providers is also warranted. Pharmacists and nursing professionals who are accustomed to limiting chemotherapy doses for obese patients should be informed of the existing evidence. IV and oral doses may be prepackaged for patients of normal weight, but appropriate dosing should be delivered, regardless of doses contained within a given vial. Arbitrary capping based on drug procurement is unacceptable (e.g., 1 vs. 1.5 vials)," the guideline stated.

Clinicians also should be aware that since rates of obesity are higher in black patients, Hispanic patients, and patients of lower socioeconomic status, these groups are harmed the most by underdosing and may benefit the most when full-weight-based dosing is adopted.

"This guideline should ease fears about administering chemotherapy based on actual body weight to otherwise healthy obese patients with cancer," Dr. Gary H. Lyman, cochair of the expert panel that drafted the guideline, said in a press statement.

"While chemotherapy dose for an obese patient may be larger than some physicians are accustomed to, they can rest assured that the risk of toxicity associated with chemotherapy dosing based on actual body weight is no greater in obese patients than in nonobese patients with cancer," said Dr. Lyman, a professor of medicine in the division of medical oncology at Duke University, Durham, N.C.

The full practice guideline, along with additional information on methodology and clinical resources, is available at ASCO’s website. For additional patient information, click here.

No financial conflicts of interest were reported.

Greater patient satisfaction with physicians was associated with increased hospitalization, higher health care expenditures, and a higher mortality risk within a few years, according to a survey of over 36,000 patients.

Some experts hold that "systematic routine measurement of patient satisfaction is a powerful quality-improvement tool for physicians and health plans," assuming that it correlates with more efficient use of the health care system, lower costs, and better results for patients. In contrast, "our data suggest that we do not fully understand what drives patient satisfaction ... or how [it] affect[s] health care use and outcomes," said Dr. Joshua J. Fenton and his associates in the department of family and community medicine and the Center for Healthcare Policy and Research, University of California–Davis.

"An overemphasis on patient satisfaction could have unintended adverse effects on health care utilization, expenditures, and outcomes," they noted. The study was published in Archives of Internal Medicine.

The researchers assessed the relationships among these factors and patient satisfaction in a prospective cohort study using data from the Medical Expenditure Panel Survey (MEPS). The MEPS is an annual, nationally representative sampling of adults who answer questionnaires pertaining to their access to, use of, and costs associated with health care.

For this study, 36,428 participants’ responses to questions about satisfaction with their physicians were assessed for the baseline year, then health care utilization and costs were assessed for the subsequent year, and mortality was assessed for up to 6 years (mean follow-up duration, 3.9 years).

The study subjects also responded to the Consumer Assessment of Health Plans Survey, which included queries about how often in the past year their physicians listened carefully, explained things in a way that was easy to understand, showed respect for what they had to say, and spent enough time with them.

The data were adjusted to account for potential confounders such as sociodemographic factors, health behaviors, access to health care, health status, insurance status, and comorbidities.

The odds that a study subject would have an inpatient admission were higher among the most satisfied patients, compared with the least satisfied (adjusted odds ratio, 1.12). And patients in the highest quartile of satisfaction showed a 9% higher total of health care expenditures and a 9% higher total of expenditures on prescription drugs, compared with those in the lowest quartile, Dr. Fenton and his colleagues said (Arch. Intern. Med. 2012;172:405-11).

In an analysis that excluded data on patients who rated their overall health as "poor" and those who had three or more chronic diseases, these associations between patient satisfaction on the one hand and health care utilization and costs on the other did not change appreciably.

During follow-up, 1,396 of the study subjects (3.8%) died. Compared with the least satisfied patients, "the most satisfied patients had a 26% greater mortality risk." This association between patient satisfaction and mortality risk remained significant in a further analysis that excluded patients who rated themselves as having "poor" health and those who had three or more chronic diseases.

Compared with the least satisfied patients, those who were most satisfied were less likely to present to the emergency department. Taken together with the other results, this finding "raises the question of whether more-satisfied patients may be differentially hospitalized for elective or less urgent indications, because nonelective urgent hospitalizations often begin with ED visits," the researchers said.

However, an alternative explanation is that people who are the least satisfied with their physicians may be more likely to seek health care at an ED rather than at their doctor’s office, they added.

This study was not designed to elucidate the reasons underlying these associations, but one possible explanation might be that patient satisfaction is a marker for illness, "identifying patients who rely more on support from their physicians and thus report higher satisfaction," Dr. Fenton and his associates said.

Overall, the study results "suggest that we may not fully understand the factors associated with patient satisfaction," they said.

"Patients typically bring expectations to medical encounters, often making specific requests of physicians, and satisfaction correlates with the extent to which physicians fulfill patient expectations." However, physicians are often required to challenge or disturb patients’ beliefs and expectations, such as when they explain the risks of requested tests or treatments and when they address lifestyle issues such as substance abuse, poor diet, or smoking.

"Relaxing patient satisfaction incentives may encourage physicians to prioritize the benefits of truthful therapeutic discourse, despite the risks of dissatisfying some patients," the investigators said.

Among the study’s limitations is that the patient satisfaction measure involved the physician and not other domains of health care, although satisfaction with one’s physician correlates with other dimensions, such as global satisfaction, the authors wrote. They also noted the possibility that patient satisfaction could differ with longer-term use and expenditure.

Greater patient satisfaction with physicians was associated with increased hospitalization, higher health care expenditures, and a higher mortality risk within a few years, according to a survey of over 36,000 patients.

Some experts hold that "systematic routine measurement of patient satisfaction is a powerful quality-improvement tool for physicians and health plans," assuming that it correlates with more efficient use of the health care system, lower costs, and better results for patients. In contrast, "our data suggest that we do not fully understand what drives patient satisfaction ... or how [it] affect[s] health care use and outcomes," said Dr. Joshua J. Fenton and his associates in the department of family and community medicine and the Center for Healthcare Policy and Research, University of California–Davis.

"An overemphasis on patient satisfaction could have unintended adverse effects on health care utilization, expenditures, and outcomes," they noted. The study was published in Archives of Internal Medicine.

The researchers assessed the relationships among these factors and patient satisfaction in a prospective cohort study using data from the Medical Expenditure Panel Survey (MEPS). The MEPS is an annual, nationally representative sampling of adults who answer questionnaires pertaining to their access to, use of, and costs associated with health care.

For this study, 36,428 participants’ responses to questions about satisfaction with their physicians were assessed for the baseline year, then health care utilization and costs were assessed for the subsequent year, and mortality was assessed for up to 6 years (mean follow-up duration, 3.9 years).

The study subjects also responded to the Consumer Assessment of Health Plans Survey, which included queries about how often in the past year their physicians listened carefully, explained things in a way that was easy to understand, showed respect for what they had to say, and spent enough time with them.

The data were adjusted to account for potential confounders such as sociodemographic factors, health behaviors, access to health care, health status, insurance status, and comorbidities.

The odds that a study subject would have an inpatient admission were higher among the most satisfied patients, compared with the least satisfied (adjusted odds ratio, 1.12). And patients in the highest quartile of satisfaction showed a 9% higher total of health care expenditures and a 9% higher total of expenditures on prescription drugs, compared with those in the lowest quartile, Dr. Fenton and his colleagues said (Arch. Intern. Med. 2012;172:405-11).

In an analysis that excluded data on patients who rated their overall health as "poor" and those who had three or more chronic diseases, these associations between patient satisfaction on the one hand and health care utilization and costs on the other did not change appreciably.

During follow-up, 1,396 of the study subjects (3.8%) died. Compared with the least satisfied patients, "the most satisfied patients had a 26% greater mortality risk." This association between patient satisfaction and mortality risk remained significant in a further analysis that excluded patients who rated themselves as having "poor" health and those who had three or more chronic diseases.

Compared with the least satisfied patients, those who were most satisfied were less likely to present to the emergency department. Taken together with the other results, this finding "raises the question of whether more-satisfied patients may be differentially hospitalized for elective or less urgent indications, because nonelective urgent hospitalizations often begin with ED visits," the researchers said.

However, an alternative explanation is that people who are the least satisfied with their physicians may be more likely to seek health care at an ED rather than at their doctor’s office, they added.

This study was not designed to elucidate the reasons underlying these associations, but one possible explanation might be that patient satisfaction is a marker for illness, "identifying patients who rely more on support from their physicians and thus report higher satisfaction," Dr. Fenton and his associates said.

Overall, the study results "suggest that we may not fully understand the factors associated with patient satisfaction," they said.

"Patients typically bring expectations to medical encounters, often making specific requests of physicians, and satisfaction correlates with the extent to which physicians fulfill patient expectations." However, physicians are often required to challenge or disturb patients’ beliefs and expectations, such as when they explain the risks of requested tests or treatments and when they address lifestyle issues such as substance abuse, poor diet, or smoking.

"Relaxing patient satisfaction incentives may encourage physicians to prioritize the benefits of truthful therapeutic discourse, despite the risks of dissatisfying some patients," the investigators said.

Among the study’s limitations is that the patient satisfaction measure involved the physician and not other domains of health care, although satisfaction with one’s physician correlates with other dimensions, such as global satisfaction, the authors wrote. They also noted the possibility that patient satisfaction could differ with longer-term use and expenditure.

Greater patient satisfaction with physicians was associated with increased hospitalization, higher health care expenditures, and a higher mortality risk within a few years, according to a survey of over 36,000 patients.

Some experts hold that "systematic routine measurement of patient satisfaction is a powerful quality-improvement tool for physicians and health plans," assuming that it correlates with more efficient use of the health care system, lower costs, and better results for patients. In contrast, "our data suggest that we do not fully understand what drives patient satisfaction ... or how [it] affect[s] health care use and outcomes," said Dr. Joshua J. Fenton and his associates in the department of family and community medicine and the Center for Healthcare Policy and Research, University of California–Davis.

"An overemphasis on patient satisfaction could have unintended adverse effects on health care utilization, expenditures, and outcomes," they noted. The study was published in Archives of Internal Medicine.

The researchers assessed the relationships among these factors and patient satisfaction in a prospective cohort study using data from the Medical Expenditure Panel Survey (MEPS). The MEPS is an annual, nationally representative sampling of adults who answer questionnaires pertaining to their access to, use of, and costs associated with health care.

For this study, 36,428 participants’ responses to questions about satisfaction with their physicians were assessed for the baseline year, then health care utilization and costs were assessed for the subsequent year, and mortality was assessed for up to 6 years (mean follow-up duration, 3.9 years).

The study subjects also responded to the Consumer Assessment of Health Plans Survey, which included queries about how often in the past year their physicians listened carefully, explained things in a way that was easy to understand, showed respect for what they had to say, and spent enough time with them.

The data were adjusted to account for potential confounders such as sociodemographic factors, health behaviors, access to health care, health status, insurance status, and comorbidities.

The odds that a study subject would have an inpatient admission were higher among the most satisfied patients, compared with the least satisfied (adjusted odds ratio, 1.12). And patients in the highest quartile of satisfaction showed a 9% higher total of health care expenditures and a 9% higher total of expenditures on prescription drugs, compared with those in the lowest quartile, Dr. Fenton and his colleagues said (Arch. Intern. Med. 2012;172:405-11).

In an analysis that excluded data on patients who rated their overall health as "poor" and those who had three or more chronic diseases, these associations between patient satisfaction on the one hand and health care utilization and costs on the other did not change appreciably.

During follow-up, 1,396 of the study subjects (3.8%) died. Compared with the least satisfied patients, "the most satisfied patients had a 26% greater mortality risk." This association between patient satisfaction and mortality risk remained significant in a further analysis that excluded patients who rated themselves as having "poor" health and those who had three or more chronic diseases.

Compared with the least satisfied patients, those who were most satisfied were less likely to present to the emergency department. Taken together with the other results, this finding "raises the question of whether more-satisfied patients may be differentially hospitalized for elective or less urgent indications, because nonelective urgent hospitalizations often begin with ED visits," the researchers said.

However, an alternative explanation is that people who are the least satisfied with their physicians may be more likely to seek health care at an ED rather than at their doctor’s office, they added.

This study was not designed to elucidate the reasons underlying these associations, but one possible explanation might be that patient satisfaction is a marker for illness, "identifying patients who rely more on support from their physicians and thus report higher satisfaction," Dr. Fenton and his associates said.

Overall, the study results "suggest that we may not fully understand the factors associated with patient satisfaction," they said.

"Patients typically bring expectations to medical encounters, often making specific requests of physicians, and satisfaction correlates with the extent to which physicians fulfill patient expectations." However, physicians are often required to challenge or disturb patients’ beliefs and expectations, such as when they explain the risks of requested tests or treatments and when they address lifestyle issues such as substance abuse, poor diet, or smoking.

"Relaxing patient satisfaction incentives may encourage physicians to prioritize the benefits of truthful therapeutic discourse, despite the risks of dissatisfying some patients," the investigators said.

Among the study’s limitations is that the patient satisfaction measure involved the physician and not other domains of health care, although satisfaction with one’s physician correlates with other dimensions, such as global satisfaction, the authors wrote. They also noted the possibility that patient satisfaction could differ with longer-term use and expenditure.

Pregnant women who carry the hepatitis B e antigen are the subgroup of women at highest risk of transmitting hepatitis B virus (HBV) infection to their children who have been immunized, Dr. Huey-Ling Chen and her colleagues reported in the April issue of Gastroenterology.

The rate of "breakthrough" HBV infection was 9.26% among children of women who were positive for the hepatitis B e antigen, markedly higher than the 0.23% rate among children of women who were HBeAg negative.

Photo courtesy CDC/ Dr. Erskine Palmert

Neonatal immunization does not eradicate mother-to-infant transmission of HBV completely, and the rate of breakthrough infection has been estimated to be at least 10%. Compared with individuals born in the preimmunization era, children who develop hepatitis B infection despite immunization are at higher risk of developing hepatocellular carcinoma, the investigators noted. "This population has been overlooked," they said.

Dr. Chen and her associates examined breakthrough HBV infection in what they described as the first large-scale study of children born to carrier mothers in Taiwan since universal neonatal HBV immunization was introduced there in 1984. Analyzing these data is crucial to "helping determine the government’s strategy for screening pregnant women, administering the neonatal HBV vaccine and the hepatitis B immunoglobulin program, and surveillance of high-risk children in the immunized population," they said (Gastroenterology 2012 April [doi:10.1053/j.gastro.2011.12.035]).

To do so, they performed a survey of 2,356 children born to mothers who carried the HBV surface antigen, a marker for HBV infection. The infants were delivered at nine tertiary referral hospitals across Taiwan during the period 1996 to 2008. A total of 583 of the children were born to HBeAg-positive mothers and 1,773 were born to HBeAg-negative mothers.

All of the children had documentation showing that they had received all three doses of the HBV vaccine as neonates. In addition, all the children of HBeAg-positive mothers had also received the mandatory hepatitis B immunoglobulin within 24 hours of birth. A total of 723 children of the HBeAg-negative mothers had received hepatitis B immunoglobulin at their parents’ request.

The rate of breakthrough HBV infection was 9.26% in children born to HBeAg-positive mothers, compared with only 0.23% in children born to HBeAg-negative mothers.

The overall rate of breakthrough infection, defined by positivity for antibodies against the hepatitis B core protein after 24 months of age, was 5.52%, but it also varied significantly based on the mothers’ hepatitis B e-antigen status. By this definition, the rate of breakthrough infection was 16.76% in children born to HBeAg-positive mothers, compared with 1.58% in children of HBeAg-negative mothers.

Similarly, the estimated rate of hepatitis chronicity was markedly higher in the children born to HBeAg-positive mothers (54%) than in those born to HBeAg-negative mothers (17%).

These differences are so large that "applying different preventive strategies to the two groups within a population-based program can be justified," said Dr. Chen, of the department of pediatrics at Taiwan University and the Hepatitis Research Center at National Taiwan University Hospital, both in Taipei, and her associates.

Now that children of e-antigen carriers have been identified as a subgroup that is particularly vulnerable to breakthrough hepatitis B infection, novel preventive methods should be targeted to these patients. For example, physicians might consider giving HBeAg-positive mothers antiviral therapy in late pregnancy to reduce the maternal viral load at delivery, the researchers said.

This vulnerable subgroup of children also would benefit from early and meticulous surveillance. "Despite breakthrough infection still occurring, HBV-related complications such as cirrhosis and hepatocellular carcinoma in the next generation may be minimized as much as possible through a well-conducted surveillance and secondary preventive system with good antiviral therapies," they noted.

In this study, it appeared that the use of hepatitis B immunoglobulin reduced the rate of breakthrough infection in children of mothers who were HBeAg negative. However, these data were misleading because the number of children who received the vaccine without immunoglobulin was quite low, and their infection rate was lower still.

"An extremely large sample size would be needed to test the difference in [breakthrough infection] rates between the two groups," and such a study does not appear feasible, Dr. Chen and her colleagues said.

This study was funded by the Center for Disease Control at the Taiwan Department of Health, and the National Taiwan University. No potential financial conflicts of interest were reported.

Pregnant women who carry the hepatitis B e antigen are the subgroup of women at highest risk of transmitting hepatitis B virus (HBV) infection to their children who have been immunized, Dr. Huey-Ling Chen and her colleagues reported in the April issue of Gastroenterology.

The rate of "breakthrough" HBV infection was 9.26% among children of women who were positive for the hepatitis B e antigen, markedly higher than the 0.23% rate among children of women who were HBeAg negative.

Photo courtesy CDC/ Dr. Erskine Palmert

Neonatal immunization does not eradicate mother-to-infant transmission of HBV completely, and the rate of breakthrough infection has been estimated to be at least 10%. Compared with individuals born in the preimmunization era, children who develop hepatitis B infection despite immunization are at higher risk of developing hepatocellular carcinoma, the investigators noted. "This population has been overlooked," they said.

Dr. Chen and her associates examined breakthrough HBV infection in what they described as the first large-scale study of children born to carrier mothers in Taiwan since universal neonatal HBV immunization was introduced there in 1984. Analyzing these data is crucial to "helping determine the government’s strategy for screening pregnant women, administering the neonatal HBV vaccine and the hepatitis B immunoglobulin program, and surveillance of high-risk children in the immunized population," they said (Gastroenterology 2012 April [doi:10.1053/j.gastro.2011.12.035]).

To do so, they performed a survey of 2,356 children born to mothers who carried the HBV surface antigen, a marker for HBV infection. The infants were delivered at nine tertiary referral hospitals across Taiwan during the period 1996 to 2008. A total of 583 of the children were born to HBeAg-positive mothers and 1,773 were born to HBeAg-negative mothers.

All of the children had documentation showing that they had received all three doses of the HBV vaccine as neonates. In addition, all the children of HBeAg-positive mothers had also received the mandatory hepatitis B immunoglobulin within 24 hours of birth. A total of 723 children of the HBeAg-negative mothers had received hepatitis B immunoglobulin at their parents’ request.

The rate of breakthrough HBV infection was 9.26% in children born to HBeAg-positive mothers, compared with only 0.23% in children born to HBeAg-negative mothers.

The overall rate of breakthrough infection, defined by positivity for antibodies against the hepatitis B core protein after 24 months of age, was 5.52%, but it also varied significantly based on the mothers’ hepatitis B e-antigen status. By this definition, the rate of breakthrough infection was 16.76% in children born to HBeAg-positive mothers, compared with 1.58% in children of HBeAg-negative mothers.

Similarly, the estimated rate of hepatitis chronicity was markedly higher in the children born to HBeAg-positive mothers (54%) than in those born to HBeAg-negative mothers (17%).

These differences are so large that "applying different preventive strategies to the two groups within a population-based program can be justified," said Dr. Chen, of the department of pediatrics at Taiwan University and the Hepatitis Research Center at National Taiwan University Hospital, both in Taipei, and her associates.

Now that children of e-antigen carriers have been identified as a subgroup that is particularly vulnerable to breakthrough hepatitis B infection, novel preventive methods should be targeted to these patients. For example, physicians might consider giving HBeAg-positive mothers antiviral therapy in late pregnancy to reduce the maternal viral load at delivery, the researchers said.

This vulnerable subgroup of children also would benefit from early and meticulous surveillance. "Despite breakthrough infection still occurring, HBV-related complications such as cirrhosis and hepatocellular carcinoma in the next generation may be minimized as much as possible through a well-conducted surveillance and secondary preventive system with good antiviral therapies," they noted.

In this study, it appeared that the use of hepatitis B immunoglobulin reduced the rate of breakthrough infection in children of mothers who were HBeAg negative. However, these data were misleading because the number of children who received the vaccine without immunoglobulin was quite low, and their infection rate was lower still.

"An extremely large sample size would be needed to test the difference in [breakthrough infection] rates between the two groups," and such a study does not appear feasible, Dr. Chen and her colleagues said.

This study was funded by the Center for Disease Control at the Taiwan Department of Health, and the National Taiwan University. No potential financial conflicts of interest were reported.

Pregnant women who carry the hepatitis B e antigen are the subgroup of women at highest risk of transmitting hepatitis B virus (HBV) infection to their children who have been immunized, Dr. Huey-Ling Chen and her colleagues reported in the April issue of Gastroenterology.

The rate of "breakthrough" HBV infection was 9.26% among children of women who were positive for the hepatitis B e antigen, markedly higher than the 0.23% rate among children of women who were HBeAg negative.

Photo courtesy CDC/ Dr. Erskine Palmert

Neonatal immunization does not eradicate mother-to-infant transmission of HBV completely, and the rate of breakthrough infection has been estimated to be at least 10%. Compared with individuals born in the preimmunization era, children who develop hepatitis B infection despite immunization are at higher risk of developing hepatocellular carcinoma, the investigators noted. "This population has been overlooked," they said.

Dr. Chen and her associates examined breakthrough HBV infection in what they described as the first large-scale study of children born to carrier mothers in Taiwan since universal neonatal HBV immunization was introduced there in 1984. Analyzing these data is crucial to "helping determine the government’s strategy for screening pregnant women, administering the neonatal HBV vaccine and the hepatitis B immunoglobulin program, and surveillance of high-risk children in the immunized population," they said (Gastroenterology 2012 April [doi:10.1053/j.gastro.2011.12.035]).

To do so, they performed a survey of 2,356 children born to mothers who carried the HBV surface antigen, a marker for HBV infection. The infants were delivered at nine tertiary referral hospitals across Taiwan during the period 1996 to 2008. A total of 583 of the children were born to HBeAg-positive mothers and 1,773 were born to HBeAg-negative mothers.

All of the children had documentation showing that they had received all three doses of the HBV vaccine as neonates. In addition, all the children of HBeAg-positive mothers had also received the mandatory hepatitis B immunoglobulin within 24 hours of birth. A total of 723 children of the HBeAg-negative mothers had received hepatitis B immunoglobulin at their parents’ request.

The rate of breakthrough HBV infection was 9.26% in children born to HBeAg-positive mothers, compared with only 0.23% in children born to HBeAg-negative mothers.

The overall rate of breakthrough infection, defined by positivity for antibodies against the hepatitis B core protein after 24 months of age, was 5.52%, but it also varied significantly based on the mothers’ hepatitis B e-antigen status. By this definition, the rate of breakthrough infection was 16.76% in children born to HBeAg-positive mothers, compared with 1.58% in children of HBeAg-negative mothers.

Similarly, the estimated rate of hepatitis chronicity was markedly higher in the children born to HBeAg-positive mothers (54%) than in those born to HBeAg-negative mothers (17%).

These differences are so large that "applying different preventive strategies to the two groups within a population-based program can be justified," said Dr. Chen, of the department of pediatrics at Taiwan University and the Hepatitis Research Center at National Taiwan University Hospital, both in Taipei, and her associates.

Now that children of e-antigen carriers have been identified as a subgroup that is particularly vulnerable to breakthrough hepatitis B infection, novel preventive methods should be targeted to these patients. For example, physicians might consider giving HBeAg-positive mothers antiviral therapy in late pregnancy to reduce the maternal viral load at delivery, the researchers said.

This vulnerable subgroup of children also would benefit from early and meticulous surveillance. "Despite breakthrough infection still occurring, HBV-related complications such as cirrhosis and hepatocellular carcinoma in the next generation may be minimized as much as possible through a well-conducted surveillance and secondary preventive system with good antiviral therapies," they noted.

In this study, it appeared that the use of hepatitis B immunoglobulin reduced the rate of breakthrough infection in children of mothers who were HBeAg negative. However, these data were misleading because the number of children who received the vaccine without immunoglobulin was quite low, and their infection rate was lower still.

"An extremely large sample size would be needed to test the difference in [breakthrough infection] rates between the two groups," and such a study does not appear feasible, Dr. Chen and her colleagues said.

This study was funded by the Center for Disease Control at the Taiwan Department of Health, and the National Taiwan University. No potential financial conflicts of interest were reported.