Mary Jo M. Dales

A single 18-fluorodeoxyglucose PET scan would be covered for staging biopsy-proven cervical cancer under a proposal issued by the Centers for Medicare and Medicaid Services.

The agency is soliciting public comments on the proposed decision and anticipates receiving expert opinion and professional society position statements before issuing a final decision.

The CMS is recommending against coverage of 18-fluorodeoxyglucose (FDG) PET imaging for the initial diagnosis of cervical cancers, since “there is no credible evidence that the results of FDG PET imaging are useful” for this indication, according to the proposal.

Prospective data collection on FDG PET imaging for initial staging of cervical cancer and evidence analysis led CMS to conclude that the results are “used by the treating physician to make meaningful changes in therapeutic management and improve health outcomes and thus are reasonable and necessary.”

CMS proposes to cover one FDG PET when performed to determine the location or extent of the tumor for the following purposes related to the initial treatment strategy:

▸ To determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or

▸ To determine the optimal anatomic location for an invasive procedure; or

▸ To determine the anatomic extent of tumor when the recommended antitumor treatment reasonably depends on the extent of the tumor.

The finding of distant metastases, in particular to the supraclavicular lymph nodes, changes the treatment strategy for cervical cancer.

“Compared with other noninvasive methods, FDG PET is more sensitive in determining lymph node involvement in initial assessment of cervical cancer,” the proposal said.

In addition, the published literature supports the beneficial effect of this strategy on initial treatment planning, “with the majority of the effect being avoidance of futile surgery,” according to CMS.

Further information about the proposed decision is available online at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=232&

A single 18-fluorodeoxyglucose PET scan would be covered for staging biopsy-proven cervical cancer under a proposal issued by the Centers for Medicare and Medicaid Services.

The agency is soliciting public comments on the proposed decision and anticipates receiving expert opinion and professional society position statements before issuing a final decision.

The CMS is recommending against coverage of 18-fluorodeoxyglucose (FDG) PET imaging for the initial diagnosis of cervical cancers, since “there is no credible evidence that the results of FDG PET imaging are useful” for this indication, according to the proposal.

Prospective data collection on FDG PET imaging for initial staging of cervical cancer and evidence analysis led CMS to conclude that the results are “used by the treating physician to make meaningful changes in therapeutic management and improve health outcomes and thus are reasonable and necessary.”

CMS proposes to cover one FDG PET when performed to determine the location or extent of the tumor for the following purposes related to the initial treatment strategy:

▸ To determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or

▸ To determine the optimal anatomic location for an invasive procedure; or

▸ To determine the anatomic extent of tumor when the recommended antitumor treatment reasonably depends on the extent of the tumor.

The finding of distant metastases, in particular to the supraclavicular lymph nodes, changes the treatment strategy for cervical cancer.

“Compared with other noninvasive methods, FDG PET is more sensitive in determining lymph node involvement in initial assessment of cervical cancer,” the proposal said.

In addition, the published literature supports the beneficial effect of this strategy on initial treatment planning, “with the majority of the effect being avoidance of futile surgery,” according to CMS.

Further information about the proposed decision is available online at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=232&

A single 18-fluorodeoxyglucose PET scan would be covered for staging biopsy-proven cervical cancer under a proposal issued by the Centers for Medicare and Medicaid Services.

The agency is soliciting public comments on the proposed decision and anticipates receiving expert opinion and professional society position statements before issuing a final decision.

The CMS is recommending against coverage of 18-fluorodeoxyglucose (FDG) PET imaging for the initial diagnosis of cervical cancers, since “there is no credible evidence that the results of FDG PET imaging are useful” for this indication, according to the proposal.

Prospective data collection on FDG PET imaging for initial staging of cervical cancer and evidence analysis led CMS to conclude that the results are “used by the treating physician to make meaningful changes in therapeutic management and improve health outcomes and thus are reasonable and necessary.”

CMS proposes to cover one FDG PET when performed to determine the location or extent of the tumor for the following purposes related to the initial treatment strategy:

▸ To determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or

▸ To determine the optimal anatomic location for an invasive procedure; or

▸ To determine the anatomic extent of tumor when the recommended antitumor treatment reasonably depends on the extent of the tumor.

The finding of distant metastases, in particular to the supraclavicular lymph nodes, changes the treatment strategy for cervical cancer.

“Compared with other noninvasive methods, FDG PET is more sensitive in determining lymph node involvement in initial assessment of cervical cancer,” the proposal said.

In addition, the published literature supports the beneficial effect of this strategy on initial treatment planning, “with the majority of the effect being avoidance of futile surgery,” according to CMS.

Further information about the proposed decision is available online at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=232&

A single18-fluorodeoxyglucose PET scan would be covered for staging biopsy-proven cervical cancer under a proposal issued by the Centers for Medicare and Medicaid Services.

The agency is soliciting public comments on the proposed decision and anticipates receiving expert opinion and professional society position statements before issuing a final decision.

The CMS is recommending against coverage of 18-fluorodeoxyglucose (FDG) PET imaging for the initial diagnosis of cervical cancers, since “there is no credible evidence that the results of FDG PET imaging are useful” for this indication, according to the proposal.

Prospective data collection on FDG PET imaging for initial staging of cervical cancer and evidence analysis led CMS to conclude that the results are “used by the treating physician to make meaningful changes in therapeutic management and improve health outcomes and thus are reasonable and necessary.”

CMS proposes to cover one FDG PET when performed to determine the location or extent of the tumor for the following purposes related to the initial treatment strategy:

▸ To determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or

▸ To determine the optimal anatomic location for an invasive procedure; or

▸ To determine the anatomic extent of tumor when the recommended antitumor treatment reasonably depends on the extent of the tumor.

The finding of distant metastases, in particular to the supraclavicular lymph nodes, changes the treatment strategy for cervical cancer. “Compared with other non-invasive methods, FDG PET is more sensitive in determining lymph node involvement in initial assessment of cervical cancer,” the proposal said. In addition, the published literature supports the beneficial effect of this strategy on initial treatment planning, “with the majority of the effect being avoidance of futile surgery,” CMS said.

More information is available at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=232&

A single18-fluorodeoxyglucose PET scan would be covered for staging biopsy-proven cervical cancer under a proposal issued by the Centers for Medicare and Medicaid Services.

The agency is soliciting public comments on the proposed decision and anticipates receiving expert opinion and professional society position statements before issuing a final decision.

The CMS is recommending against coverage of 18-fluorodeoxyglucose (FDG) PET imaging for the initial diagnosis of cervical cancers, since “there is no credible evidence that the results of FDG PET imaging are useful” for this indication, according to the proposal.

Prospective data collection on FDG PET imaging for initial staging of cervical cancer and evidence analysis led CMS to conclude that the results are “used by the treating physician to make meaningful changes in therapeutic management and improve health outcomes and thus are reasonable and necessary.”

CMS proposes to cover one FDG PET when performed to determine the location or extent of the tumor for the following purposes related to the initial treatment strategy:

▸ To determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or

▸ To determine the optimal anatomic location for an invasive procedure; or

▸ To determine the anatomic extent of tumor when the recommended antitumor treatment reasonably depends on the extent of the tumor.

The finding of distant metastases, in particular to the supraclavicular lymph nodes, changes the treatment strategy for cervical cancer. “Compared with other non-invasive methods, FDG PET is more sensitive in determining lymph node involvement in initial assessment of cervical cancer,” the proposal said. In addition, the published literature supports the beneficial effect of this strategy on initial treatment planning, “with the majority of the effect being avoidance of futile surgery,” CMS said.

More information is available at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=232&

A single18-fluorodeoxyglucose PET scan would be covered for staging biopsy-proven cervical cancer under a proposal issued by the Centers for Medicare and Medicaid Services.

The agency is soliciting public comments on the proposed decision and anticipates receiving expert opinion and professional society position statements before issuing a final decision.

The CMS is recommending against coverage of 18-fluorodeoxyglucose (FDG) PET imaging for the initial diagnosis of cervical cancers, since “there is no credible evidence that the results of FDG PET imaging are useful” for this indication, according to the proposal.

Prospective data collection on FDG PET imaging for initial staging of cervical cancer and evidence analysis led CMS to conclude that the results are “used by the treating physician to make meaningful changes in therapeutic management and improve health outcomes and thus are reasonable and necessary.”

CMS proposes to cover one FDG PET when performed to determine the location or extent of the tumor for the following purposes related to the initial treatment strategy:

▸ To determine whether the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or

▸ To determine the optimal anatomic location for an invasive procedure; or

▸ To determine the anatomic extent of tumor when the recommended antitumor treatment reasonably depends on the extent of the tumor.

The finding of distant metastases, in particular to the supraclavicular lymph nodes, changes the treatment strategy for cervical cancer. “Compared with other non-invasive methods, FDG PET is more sensitive in determining lymph node involvement in initial assessment of cervical cancer,” the proposal said. In addition, the published literature supports the beneficial effect of this strategy on initial treatment planning, “with the majority of the effect being avoidance of futile surgery,” CMS said.

More information is available at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=232&

Another diagnostic test for the 2009 H1N1 influenza virus received an Emergency Use Authorization by the Food and Drug Administration.

The Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third H1N1 diagnostic test to be authorized by the FDA under the Emergency Use Authorization since a public health emergency involving the virus was declared, the agency said in a written statement.

The Emergency Use Authorization allows use of unapproved medical products or unapproved uses of approved medical products following a declaration of emergency.

The Focus Diagnostics test is an unapproved device. The authorization ends once the emergency is terminated or when the FDA revokes the authorization. Focus Diagnostics will be permitted to distribute the test to laboratories certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.

"This authorization will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said in a released statement.

Focus Diagnostics is a subsidiary of Quest Diagnostics and is located in Cypress, Calif.

Another diagnostic test for the 2009 H1N1 influenza virus received an Emergency Use Authorization by the Food and Drug Administration.

The Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third H1N1 diagnostic test to be authorized by the FDA under the Emergency Use Authorization since a public health emergency involving the virus was declared, the agency said in a written statement.

The Emergency Use Authorization allows use of unapproved medical products or unapproved uses of approved medical products following a declaration of emergency.

The Focus Diagnostics test is an unapproved device. The authorization ends once the emergency is terminated or when the FDA revokes the authorization. Focus Diagnostics will be permitted to distribute the test to laboratories certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.

"This authorization will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said in a released statement.

Focus Diagnostics is a subsidiary of Quest Diagnostics and is located in Cypress, Calif.

Another diagnostic test for the 2009 H1N1 influenza virus received an Emergency Use Authorization by the Food and Drug Administration.

The Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third H1N1 diagnostic test to be authorized by the FDA under the Emergency Use Authorization since a public health emergency involving the virus was declared, the agency said in a written statement.

The Emergency Use Authorization allows use of unapproved medical products or unapproved uses of approved medical products following a declaration of emergency.

The Focus Diagnostics test is an unapproved device. The authorization ends once the emergency is terminated or when the FDA revokes the authorization. Focus Diagnostics will be permitted to distribute the test to laboratories certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.

"This authorization will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said in a released statement.

Focus Diagnostics is a subsidiary of Quest Diagnostics and is located in Cypress, Calif.

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers on combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking.

The Women's Health Initiative (WHI) was a randomized, placebo-controlled clinical trial that examined the health effects of continued use of conjugated equine estrogen plus medroxyprogesterone in 16,608 mostly healthy postmenopausal women. In current practice, HT is recommended for brief use in the treatment of menopausal symptoms, offers alternative hormone sources, and is given at doses that are about half of those used in the WHI. The WHI was launched in 1993; the estrogen-progestin arm of the WHI was stopped in 2002.

This is the first study to examine a specific correlation between non-small cell lung cancer (NSCLC) and HT in a randomized, double-blind design and with a large, ethnically diverse population. A limitation of this study was the secondary nature of the analyses. The findings on the risk and outcome of lung cancer were not a primary objective of the WHI.

NSCLC incidence and mortality were studied during the 5.6 years of HT or placebo and 2.4 years of follow-up. While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the HT group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases among controls. Median survival was 9.4 months in the HT group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the HT group, 27 occurred in 800 current smokers. The other deaths included 9 in 4,178 never smokers and 29 in 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

Dr. Chlebowski said in an interview that a prospective randomized trial of women on current regimens would be preferable, but that study would be large and costly and therefore unlikely.

Dr. Chlebowski is a consultant for numerous pharmaceutical companies, none relevant to the WHI analysis.

To see an interview with Dr. Chlebowski, visit www.youtube.com/user/ClinicalEndoNews

Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking.

Source DR. CHLEBOWSKI

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers on combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking.

The Women's Health Initiative (WHI) was a randomized, placebo-controlled clinical trial that examined the health effects of continued use of conjugated equine estrogen plus medroxyprogesterone in 16,608 mostly healthy postmenopausal women. In current practice, HT is recommended for brief use in the treatment of menopausal symptoms, offers alternative hormone sources, and is given at doses that are about half of those used in the WHI. The WHI was launched in 1993; the estrogen-progestin arm of the WHI was stopped in 2002.

This is the first study to examine a specific correlation between non-small cell lung cancer (NSCLC) and HT in a randomized, double-blind design and with a large, ethnically diverse population. A limitation of this study was the secondary nature of the analyses. The findings on the risk and outcome of lung cancer were not a primary objective of the WHI.

NSCLC incidence and mortality were studied during the 5.6 years of HT or placebo and 2.4 years of follow-up. While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the HT group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases among controls. Median survival was 9.4 months in the HT group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the HT group, 27 occurred in 800 current smokers. The other deaths included 9 in 4,178 never smokers and 29 in 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

Dr. Chlebowski said in an interview that a prospective randomized trial of women on current regimens would be preferable, but that study would be large and costly and therefore unlikely.

Dr. Chlebowski is a consultant for numerous pharmaceutical companies, none relevant to the WHI analysis.

To see an interview with Dr. Chlebowski, visit www.youtube.com/user/ClinicalEndoNews

Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking.

Source DR. CHLEBOWSKI

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers on combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking.

The Women's Health Initiative (WHI) was a randomized, placebo-controlled clinical trial that examined the health effects of continued use of conjugated equine estrogen plus medroxyprogesterone in 16,608 mostly healthy postmenopausal women. In current practice, HT is recommended for brief use in the treatment of menopausal symptoms, offers alternative hormone sources, and is given at doses that are about half of those used in the WHI. The WHI was launched in 1993; the estrogen-progestin arm of the WHI was stopped in 2002.

This is the first study to examine a specific correlation between non-small cell lung cancer (NSCLC) and HT in a randomized, double-blind design and with a large, ethnically diverse population. A limitation of this study was the secondary nature of the analyses. The findings on the risk and outcome of lung cancer were not a primary objective of the WHI.

NSCLC incidence and mortality were studied during the 5.6 years of HT or placebo and 2.4 years of follow-up. While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the HT group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases among controls. Median survival was 9.4 months in the HT group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the HT group, 27 occurred in 800 current smokers. The other deaths included 9 in 4,178 never smokers and 29 in 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

Dr. Chlebowski said in an interview that a prospective randomized trial of women on current regimens would be preferable, but that study would be large and costly and therefore unlikely.

Dr. Chlebowski is a consultant for numerous pharmaceutical companies, none relevant to the WHI analysis.

To see an interview with Dr. Chlebowski, visit www.youtube.com/user/ClinicalEndoNews

Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking.

Source DR. CHLEBOWSKI

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers using combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving hormone therapy should be strongly advised to quit smoking.

The incidence and mortality of non-small cell lung cancer (NSCLC) were examined during 5.6 years of intervention with HT or placebo and 2.4 additional years of follow-up.

While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the hormone therapy group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases in the control group. Further, median survival was 9.4 months in the hormone therapy group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the hormone therapy group, 27 occurred in 800 current smokers. The other 38 deaths occurred in 9 of 4,178 never smokers and in 29 of 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

Dr. Chlebowski disclosed that he is a consultant and adviser to numerous pharmaceutical companies. These disclosures were not relevant to the WHI analysis.

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers using combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving hormone therapy should be strongly advised to quit smoking.

The incidence and mortality of non-small cell lung cancer (NSCLC) were examined during 5.6 years of intervention with HT or placebo and 2.4 additional years of follow-up.

While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the hormone therapy group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases in the control group. Further, median survival was 9.4 months in the hormone therapy group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the hormone therapy group, 27 occurred in 800 current smokers. The other 38 deaths occurred in 9 of 4,178 never smokers and in 29 of 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

Dr. Chlebowski disclosed that he is a consultant and adviser to numerous pharmaceutical companies. These disclosures were not relevant to the WHI analysis.

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers using combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving hormone therapy should be strongly advised to quit smoking.

The incidence and mortality of non-small cell lung cancer (NSCLC) were examined during 5.6 years of intervention with HT or placebo and 2.4 additional years of follow-up.

While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the hormone therapy group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases in the control group. Further, median survival was 9.4 months in the hormone therapy group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the hormone therapy group, 27 occurred in 800 current smokers. The other 38 deaths occurred in 9 of 4,178 never smokers and in 29 of 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

Dr. Chlebowski disclosed that he is a consultant and adviser to numerous pharmaceutical companies. These disclosures were not relevant to the WHI analysis.

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers using combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving hormone therapy should be strongly advised to quit smoking.

The Women's Health Initiative (WHI) was a randomized, placebo-controlled clinical trial that examined the health effects of continued use of conjugated equine estrogen plus medroxyprogesterone in 16,608 mostly healthy postmenopausal women. In current practice, HT is recommended for brief use in the treatment of menopausal symptoms, offers alternative hormone sources, and is given at doses that are about half of those used in the WHI. The WHI was launched in 1993; the estrogen-progestin arm of the WHI was stopped in 2002.

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death in women. Previous research indicates that hormones play a role in NSCLC, but this is the first study to examine a specific correlation in a randomized, double-blind design and with a large, ethnically diverse population. A limitation of this study was the secondary nature of the analyses. The findings on the risk and outcome of lung cancer were not a primary objective of the WHI.

NSCLC incidence and mortality were examined during the 5.6 years of intervention with HT or placebo and 2.4 additional years of follow-up.

While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the hormone therapy group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases in the control group. Further, median survival was 9.4 months in the HT group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the hormone therapy group, 27 occurred in 800 current smokers. The other 38 deaths occurred in 9 of 4,178 never smokers and in 29 of 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

The nature of HT has changed since the WHI, with most women on lower-dose therapies for shorter periods of time, Dr. Chlebowski acknowledged in an interview.

Dr. Chlebowski disclosed that he is a consultant and adviser to many pharmaceutical companies. These disclosures were not relevant to the WHI analysis.

A related video is at www.youtube.com/InternalMedicineNews

Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking. DR. CHLEBOWSKI

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers using combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving hormone therapy should be strongly advised to quit smoking.

The Women's Health Initiative (WHI) was a randomized, placebo-controlled clinical trial that examined the health effects of continued use of conjugated equine estrogen plus medroxyprogesterone in 16,608 mostly healthy postmenopausal women. In current practice, HT is recommended for brief use in the treatment of menopausal symptoms, offers alternative hormone sources, and is given at doses that are about half of those used in the WHI. The WHI was launched in 1993; the estrogen-progestin arm of the WHI was stopped in 2002.

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death in women. Previous research indicates that hormones play a role in NSCLC, but this is the first study to examine a specific correlation in a randomized, double-blind design and with a large, ethnically diverse population. A limitation of this study was the secondary nature of the analyses. The findings on the risk and outcome of lung cancer were not a primary objective of the WHI.

NSCLC incidence and mortality were examined during the 5.6 years of intervention with HT or placebo and 2.4 additional years of follow-up.

While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the hormone therapy group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases in the control group. Further, median survival was 9.4 months in the HT group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the hormone therapy group, 27 occurred in 800 current smokers. The other 38 deaths occurred in 9 of 4,178 never smokers and in 29 of 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

The nature of HT has changed since the WHI, with most women on lower-dose therapies for shorter periods of time, Dr. Chlebowski acknowledged in an interview.

Dr. Chlebowski disclosed that he is a consultant and adviser to many pharmaceutical companies. These disclosures were not relevant to the WHI analysis.

A related video is at www.youtube.com/InternalMedicineNews

Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking. DR. CHLEBOWSKI

ORLANDO — Hormone therapy with estrogen plus progestin for more than 5 years increased the risk of death in women diagnosed with non-small cell lung cancer, based on secondary analyses from the Women's Health Initiative reported at the annual meeting of the American Society of Clinical Oncology.

The increased risk was most notable in women who were current smokers. One in 100 current smokers using combined hormone therapy (HT) in the trial experienced an avoidable death from non-small cell lung cancer during the 8 years of this study, said Dr. Rowan Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the study's lead author.

The findings “should influence discussions between physicians and women considering hormone therapy use, especially for those with a smoking history,” Dr. Chlebowski said. Women who smoke and are seeking or already receiving hormone therapy should be strongly advised to quit smoking.

The Women's Health Initiative (WHI) was a randomized, placebo-controlled clinical trial that examined the health effects of continued use of conjugated equine estrogen plus medroxyprogesterone in 16,608 mostly healthy postmenopausal women. In current practice, HT is recommended for brief use in the treatment of menopausal symptoms, offers alternative hormone sources, and is given at doses that are about half of those used in the WHI. The WHI was launched in 1993; the estrogen-progestin arm of the WHI was stopped in 2002.

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death in women. Previous research indicates that hormones play a role in NSCLC, but this is the first study to examine a specific correlation in a randomized, double-blind design and with a large, ethnically diverse population. A limitation of this study was the secondary nature of the analyses. The findings on the risk and outcome of lung cancer were not a primary objective of the WHI.

NSCLC incidence and mortality were examined during the 5.6 years of intervention with HT or placebo and 2.4 additional years of follow-up.

While the incidence of NSCLC diagnosis was not significantly different for controls and women on HT, survival after diagnosis was significantly lower in the hormone therapy group. There were 67 deaths among 96 women on HT and 39 deaths in 72 cases in the control group. Further, median survival was 9.4 months in the HT group and 16.1 months in the control group.

The HT and control groups were evenly matched for smoking history with 50% never smokers, 40% former smokers, and 10% current smokers. But when the data on NSCLC deaths were analyzed by tobacco use, the risk was higher in current smokers and considerably higher in smokers also taking HT.

Of the 67 NSCLC deaths in the hormone therapy group, 27 occurred in 800 current smokers. The other 38 deaths occurred in 9 of 4,178 never smokers and in 29 of 3,362 former smokers. Of the 39 NSCLC deaths in the control group, 19 occurred in 838 current smokers. The other 20 deaths occurred in 5 of 3,999 never smokers and in 15 of 3,157 past smokers.

The nature of HT has changed since the WHI, with most women on lower-dose therapies for shorter periods of time, Dr. Chlebowski acknowledged in an interview.

Dr. Chlebowski disclosed that he is a consultant and adviser to many pharmaceutical companies. These disclosures were not relevant to the WHI analysis.

A related video is at www.youtube.com/InternalMedicineNews

Women who smoke and are seeking or already receiving HT should be strongly advised to quit smoking. DR. CHLEBOWSKI

ORLANDO — Routine measurements of CA125 conferred no survival advantage in the follow-up of ovarian cancer patients, according to the results of a large, double-blind, prospective, placebo-controlled study presented at the annual meeting of the American Society of Clinical Oncology.

CA125 screening is essential for the diagnosis of ovarian cancer at a stage that is potentially curable. But when used as a monitoring tool for early detection of recurrent cancer in patients in remission, measuring CA125 actually causes women to undergo more cycles of chemotherapy with no improvement in their survival and a decline in their quality of life, reported Dr. Gordon J. Rustin.

This is level 1 evidence that women need not continue to have quarterly measures of CA125 outside the realm of a clinical trial, commented the invited discussant for the paper, Dr. Beth Y. Karlan, a professor of obstetrics and gynecology at the University of California, Los Angeles.

The importance of this study cannot be overemphasized, Dr. Eric P. Winer said during a press briefing at the meeting. These findings can potentially improve the quality of life for all women with stage III or IV ovarian cancer, as well as result in substantial economic savings.

Dr. Rustin, of Mount Vernon Cancer Centre, Middlesex, England, presented the data on behalf of the MRC OV05 (Medical Research Council OV05) and EORTC 55955 (European Organisation for Research and Treatment of Cancer 55955) trial investigators. The trial registered 1,442 patients at 59 sites in 10 countries and was designed to determine whether there were benefits from early treatment of recurrent cancer based on a confirmed elevation of CA125 levels, compared with delaying treatment until clinical symptoms were noted.

Women who had ovarian cancer that was in clinical complete remission after first-line platinum-based chemotherapy and a normal CA125 value were registered in the study. Most were 6 months post diagnosis and had advanced FIGO stage III or IV cancers and serous histology, the type of ovarian cancer expected to relapse. CA125 was measured every 3 months in all of the women. Patients and investigators were blinded to the test results.

CA125 levels exceeded twice the upper limit of normal in 527 patients, who were then randomized to either immediate treatment or to delayed therapy in which they continued to have blinded CA125 measurements but did not begin treatment until they had clinical or symptomatic recurrences. Patients in both arms were treated according to standard local practice. The other 915 patients were not randomized because they had no CA125 rise and no relapse (48%); they relapsed with or without CA125 (30%), they died (6%) or withdrew from the study (14%), or for other reasons (2%).

Patients in the early treatment arm of the study started their regimens 0.8 months after randomization, compared with 5.6 months in the women whose treatment was delayed until they were symptomatic. In the early treatment arm, 68% of women went on to third-line chemotherapy, compared with 56% of women in the delayed treatment arm. Those in the early treatment arm had relapses, on average, 4.6 months earlier than did the women in the delayed treatment arm, an indication that early treatment does not offer longer remissions.

Also, study participants completed quality of life surveys every 3 months. Those in the early treatment arm had earlier declines in quality of life by 3 months. Early chemotherapy not only failed to improve quality of life, it made quality of life worse.

The data were frozen at 56.9 months of follow-up with “absolutely no difference in survival,” Dr. Rustin said. The trial lasted as long as it did because of overall good survival. The study was designed to detect a 10% improvement in 2-year overall survival in the immediate treatment arm.

These findings mean that women can be offered informed choices about CA125 monitoring after first-line chemotherapy, Dr. Rustin said. They can opt to defer testing until they develop symptoms, as long as they recognize the importance of returning at the first sign of symptoms, and feel assured that they will have the same outcomes as women who continue CA125 monitoring.

In the United Kingdom, CA125 tests are available “in the local chemist shop, and women are almost addicted to getting them,” he said during an interview. Many say they feel as though they are living from one test to the next. Now they need not have the anxiety that accompanies each routine monitoring test and can rely on clinical symptoms. As a result, these women will have far fewer courses of toxic chemotherapy and the same chance of survival.

Dr. Karlan said the findings will have a major impact on the cost of health care by decreasing the use of resources not shown to improve overall survival and quality of life. There will be less frequent assays, fewer follow-up tests, and improved quality of life.

It will take some time for patients to feel comfortable with this change in approach, she acknowledged, but the message to not worry about the next CA125 value should be a positive one for them. “So many live from one CA125 measure to the next and any small bumps in their levels can cause them great anxiety and distress.”

Dr. Karlan commented that the study, although very well done, also has some weaknesses. There was a lack of prescribed secondary- or tertiary-line chemotherapy, and the type of surgery was not considered. New drugs have come along. Platinum resistance and sensitivity were not factored into the analysis.

The study also points out the therapeutic limitations in advanced ovarian cancer, “a choice of whittling away at small disease or carving out large disease.” The findings should renew efforts to detect this disease at its earliest, and potentially curable, stage, she said.

The investigators had no relevant conflicts of interest in regard to this study.

At 56.9 months of follow-up, women who underwent CA125 monitoring had 'absolutely no difference in survival.' DR. RUSTIN

ORLANDO — Routine measurements of CA125 conferred no survival advantage in the follow-up of ovarian cancer patients, according to the results of a large, double-blind, prospective, placebo-controlled study presented at the annual meeting of the American Society of Clinical Oncology.

CA125 screening is essential for the diagnosis of ovarian cancer at a stage that is potentially curable. But when used as a monitoring tool for early detection of recurrent cancer in patients in remission, measuring CA125 actually causes women to undergo more cycles of chemotherapy with no improvement in their survival and a decline in their quality of life, reported Dr. Gordon J. Rustin.

This is level 1 evidence that women need not continue to have quarterly measures of CA125 outside the realm of a clinical trial, commented the invited discussant for the paper, Dr. Beth Y. Karlan, a professor of obstetrics and gynecology at the University of California, Los Angeles.

The importance of this study cannot be overemphasized, Dr. Eric P. Winer said during a press briefing at the meeting. These findings can potentially improve the quality of life for all women with stage III or IV ovarian cancer, as well as result in substantial economic savings.

Dr. Rustin, of Mount Vernon Cancer Centre, Middlesex, England, presented the data on behalf of the MRC OV05 (Medical Research Council OV05) and EORTC 55955 (European Organisation for Research and Treatment of Cancer 55955) trial investigators. The trial registered 1,442 patients at 59 sites in 10 countries and was designed to determine whether there were benefits from early treatment of recurrent cancer based on a confirmed elevation of CA125 levels, compared with delaying treatment until clinical symptoms were noted.

Women who had ovarian cancer that was in clinical complete remission after first-line platinum-based chemotherapy and a normal CA125 value were registered in the study. Most were 6 months post diagnosis and had advanced FIGO stage III or IV cancers and serous histology, the type of ovarian cancer expected to relapse. CA125 was measured every 3 months in all of the women. Patients and investigators were blinded to the test results.

CA125 levels exceeded twice the upper limit of normal in 527 patients, who were then randomized to either immediate treatment or to delayed therapy in which they continued to have blinded CA125 measurements but did not begin treatment until they had clinical or symptomatic recurrences. Patients in both arms were treated according to standard local practice. The other 915 patients were not randomized because they had no CA125 rise and no relapse (48%); they relapsed with or without CA125 (30%), they died (6%) or withdrew from the study (14%), or for other reasons (2%).

Patients in the early treatment arm of the study started their regimens 0.8 months after randomization, compared with 5.6 months in the women whose treatment was delayed until they were symptomatic. In the early treatment arm, 68% of women went on to third-line chemotherapy, compared with 56% of women in the delayed treatment arm. Those in the early treatment arm had relapses, on average, 4.6 months earlier than did the women in the delayed treatment arm, an indication that early treatment does not offer longer remissions.

Also, study participants completed quality of life surveys every 3 months. Those in the early treatment arm had earlier declines in quality of life by 3 months. Early chemotherapy not only failed to improve quality of life, it made quality of life worse.

The data were frozen at 56.9 months of follow-up with “absolutely no difference in survival,” Dr. Rustin said. The trial lasted as long as it did because of overall good survival. The study was designed to detect a 10% improvement in 2-year overall survival in the immediate treatment arm.

These findings mean that women can be offered informed choices about CA125 monitoring after first-line chemotherapy, Dr. Rustin said. They can opt to defer testing until they develop symptoms, as long as they recognize the importance of returning at the first sign of symptoms, and feel assured that they will have the same outcomes as women who continue CA125 monitoring.

In the United Kingdom, CA125 tests are available “in the local chemist shop, and women are almost addicted to getting them,” he said during an interview. Many say they feel as though they are living from one test to the next. Now they need not have the anxiety that accompanies each routine monitoring test and can rely on clinical symptoms. As a result, these women will have far fewer courses of toxic chemotherapy and the same chance of survival.

Dr. Karlan said the findings will have a major impact on the cost of health care by decreasing the use of resources not shown to improve overall survival and quality of life. There will be less frequent assays, fewer follow-up tests, and improved quality of life.

It will take some time for patients to feel comfortable with this change in approach, she acknowledged, but the message to not worry about the next CA125 value should be a positive one for them. “So many live from one CA125 measure to the next and any small bumps in their levels can cause them great anxiety and distress.”

Dr. Karlan commented that the study, although very well done, also has some weaknesses. There was a lack of prescribed secondary- or tertiary-line chemotherapy, and the type of surgery was not considered. New drugs have come along. Platinum resistance and sensitivity were not factored into the analysis.

The study also points out the therapeutic limitations in advanced ovarian cancer, “a choice of whittling away at small disease or carving out large disease.” The findings should renew efforts to detect this disease at its earliest, and potentially curable, stage, she said.

The investigators had no relevant conflicts of interest in regard to this study.

At 56.9 months of follow-up, women who underwent CA125 monitoring had 'absolutely no difference in survival.' DR. RUSTIN

ORLANDO — Routine measurements of CA125 conferred no survival advantage in the follow-up of ovarian cancer patients, according to the results of a large, double-blind, prospective, placebo-controlled study presented at the annual meeting of the American Society of Clinical Oncology.

CA125 screening is essential for the diagnosis of ovarian cancer at a stage that is potentially curable. But when used as a monitoring tool for early detection of recurrent cancer in patients in remission, measuring CA125 actually causes women to undergo more cycles of chemotherapy with no improvement in their survival and a decline in their quality of life, reported Dr. Gordon J. Rustin.

This is level 1 evidence that women need not continue to have quarterly measures of CA125 outside the realm of a clinical trial, commented the invited discussant for the paper, Dr. Beth Y. Karlan, a professor of obstetrics and gynecology at the University of California, Los Angeles.

The importance of this study cannot be overemphasized, Dr. Eric P. Winer said during a press briefing at the meeting. These findings can potentially improve the quality of life for all women with stage III or IV ovarian cancer, as well as result in substantial economic savings.

Dr. Rustin, of Mount Vernon Cancer Centre, Middlesex, England, presented the data on behalf of the MRC OV05 (Medical Research Council OV05) and EORTC 55955 (European Organisation for Research and Treatment of Cancer 55955) trial investigators. The trial registered 1,442 patients at 59 sites in 10 countries and was designed to determine whether there were benefits from early treatment of recurrent cancer based on a confirmed elevation of CA125 levels, compared with delaying treatment until clinical symptoms were noted.

Women who had ovarian cancer that was in clinical complete remission after first-line platinum-based chemotherapy and a normal CA125 value were registered in the study. Most were 6 months post diagnosis and had advanced FIGO stage III or IV cancers and serous histology, the type of ovarian cancer expected to relapse. CA125 was measured every 3 months in all of the women. Patients and investigators were blinded to the test results.

CA125 levels exceeded twice the upper limit of normal in 527 patients, who were then randomized to either immediate treatment or to delayed therapy in which they continued to have blinded CA125 measurements but did not begin treatment until they had clinical or symptomatic recurrences. Patients in both arms were treated according to standard local practice. The other 915 patients were not randomized because they had no CA125 rise and no relapse (48%); they relapsed with or without CA125 (30%), they died (6%) or withdrew from the study (14%), or for other reasons (2%).

Patients in the early treatment arm of the study started their regimens 0.8 months after randomization, compared with 5.6 months in the women whose treatment was delayed until they were symptomatic. In the early treatment arm, 68% of women went on to third-line chemotherapy, compared with 56% of women in the delayed treatment arm. Those in the early treatment arm had relapses, on average, 4.6 months earlier than did the women in the delayed treatment arm, an indication that early treatment does not offer longer remissions.

Also, study participants completed quality of life surveys every 3 months. Those in the early treatment arm had earlier declines in quality of life by 3 months. Early chemotherapy not only failed to improve quality of life, it made quality of life worse.

The data were frozen at 56.9 months of follow-up with “absolutely no difference in survival,” Dr. Rustin said. The trial lasted as long as it did because of overall good survival. The study was designed to detect a 10% improvement in 2-year overall survival in the immediate treatment arm.

These findings mean that women can be offered informed choices about CA125 monitoring after first-line chemotherapy, Dr. Rustin said. They can opt to defer testing until they develop symptoms, as long as they recognize the importance of returning at the first sign of symptoms, and feel assured that they will have the same outcomes as women who continue CA125 monitoring.

In the United Kingdom, CA125 tests are available “in the local chemist shop, and women are almost addicted to getting them,” he said during an interview. Many say they feel as though they are living from one test to the next. Now they need not have the anxiety that accompanies each routine monitoring test and can rely on clinical symptoms. As a result, these women will have far fewer courses of toxic chemotherapy and the same chance of survival.

Dr. Karlan said the findings will have a major impact on the cost of health care by decreasing the use of resources not shown to improve overall survival and quality of life. There will be less frequent assays, fewer follow-up tests, and improved quality of life.

It will take some time for patients to feel comfortable with this change in approach, she acknowledged, but the message to not worry about the next CA125 value should be a positive one for them. “So many live from one CA125 measure to the next and any small bumps in their levels can cause them great anxiety and distress.”

Dr. Karlan commented that the study, although very well done, also has some weaknesses. There was a lack of prescribed secondary- or tertiary-line chemotherapy, and the type of surgery was not considered. New drugs have come along. Platinum resistance and sensitivity were not factored into the analysis.

The study also points out the therapeutic limitations in advanced ovarian cancer, “a choice of whittling away at small disease or carving out large disease.” The findings should renew efforts to detect this disease at its earliest, and potentially curable, stage, she said.

The investigators had no relevant conflicts of interest in regard to this study.

At 56.9 months of follow-up, women who underwent CA125 monitoring had 'absolutely no difference in survival.' DR. RUSTIN

SAN DIEGO — Insulin-use patterns and glycemic control improved, while episodes of hypoglycemia declined, among non-critical care patients with diabetes after structured insulin orders and an insulin management algorithm were added to the hospital order set at the University of California, San Diego Medical Center.

After the structured insulin order set was added, the relative risk of an inpatient stay decreased to 0.84 when the mean blood glucose level was greater than 180 mg/dL. With the order set plus the algorithm in place, the relative risks of an uncontrolled patient day and an uncontrolled patient stay declined to 0.77 and to 0.73, respectively. Furthermore, the relative risks of hypoglycemia per patient day and patient stay declined to 0.80 and 0.92, respectively, and the percentage of patient days with hypoglycemia decreased from 3.7% to 2.6%.

The findings are based on data from more than 5,500 subjects who had at least seven glucose measures during stays at the UCSD center. Data were compared for the year before the institution of the order set, for 18 months after introduction of the order set alone, and for the subsequent 8 months after the algorithm was added to the order set.

The success of the order set and the one-page algorithm—which recommended treatment pathways for adult medical and surgical inpatients who had a diagnosis of diabetes or documented hyperglycemia—were reported at the annual meeting of the Society of Hospital Medicine by Dr. Greg Maynard, chief of the division of hospital medicine at UCSD. The pathways were tailored to whether inpatients were receiving regular meals, were under NPO (nothing by mouth) orders, or were tube fed.

The outcomes were a “win-win situation,” he said. The “chaotic swings” in glycemia seen before the order set was instituted gave way to better control, and no special team was needed to get the results. He attributed most of the good results to a shift to basal/bolus insulin regimens from sliding-scale insulin regimens. After the order set and algorithm were instituted, sliding-scale-only insulin regimens decreased from 72% of 477 insulin regimens to 26% of 499 insulin regimens.

The next step for inpatient diabetes research, according to Dr. Maynard, is to develop reaction and prevention protocols. Suboptimal response to episodes of hyper- and hypoglycemia is the norm in hospitals, he said. “We don't take action when it should be taken, and opportunities to prevent hypoglycemia are missed.”

As an example, Dr. Maynard discussed the results of a study published last year. Within 48 hours after they were given an antihyperglycemic agent, 10% of 2,174 hospitalized patients with diabetes had hypoglycemia. Of those 206 patients, 44% had more than one hypoglycemic event. No adverse events accompanied 464 of the hypoglycemic episodes; there were 20 adverse events and 10 of these resulted in seizures or loss of consciousness. None of the adverse events was attributable to medication errors, and just 11% of the patients were on oral-only regimens.

About half of the hypoglycemic events were associated with reductions in enteral intake, but the precipitating factors were unclear in the other half. Just one-third of patients had their blood glucose rechecked within 60 minutes and fewer than half had documented euglycemia within 2 hours of their hypoglycemia; the average time to a documented resolution was 4 hours (J. Hosp. Med. 2007;2:234-40).

Dr. Maynard also advised examining patients' outpatient diabetes regimens, and imparted some recommendations for transitioning patients at hospital discharge.

The patient who was taking metformin and was admitted with a hemoglobin A_1c level greater than 9% and a baseline glucose measure of more than 350 mg/dL clearly needs her regimen adjusted, he said. But any recommendations need to consider her physical limitations; any new comorbidities; her willingness and ability to self-monitor; treatment goals; hypoglycemia risk factors; and the patient's financial situation. “You're not going to shoot for [a blood glucose level of] 110 mg/dL in a hospice patient, or encourage self-monitoring four times per day in a patient who can't afford it or is unwilling to do the tests,” he said. Those considerations weigh into treatment selection.

Dr. Maynard offered the following general observations to consider when you select a discharge therapy.

▸ Once HbA_1c exceeds 8.5%, additional oral agents are unlikely to achieve goals.

▸ Insulin at bedtime is a good initial strategy.

▸ Testing drives the cost of therapy. Testing four times per day is more expensive than insulin.

▸ Elderly patients are at higher risk for hypoglycemia. Decrease their insulin as they get better, and make sure they have good follow-up and aren't being overtreated.

▸ Glyburide has been linked with a higher risk of hypoglycemia than has glipizide.

▸ The evidence on risk factors is imperfect, but be hesitant to start glitazones de novo.

As a treatment reference, Dr. Maynard suggested algorithms available at the Web site of the American Academy of Clinical Endocrinologists (www.aace.com/resources/igcrcwww.hospitalmedicine.org/ResourceRoomRedesign/GlycemicControl.cfm

Dr. Maynard reported that he and his coinvestigators had no disclosures related to the study.

SAN DIEGO — Insulin-use patterns and glycemic control improved, while episodes of hypoglycemia declined, among non-critical care patients with diabetes after structured insulin orders and an insulin management algorithm were added to the hospital order set at the University of California, San Diego Medical Center.

After the structured insulin order set was added, the relative risk of an inpatient stay decreased to 0.84 when the mean blood glucose level was greater than 180 mg/dL. With the order set plus the algorithm in place, the relative risks of an uncontrolled patient day and an uncontrolled patient stay declined to 0.77 and to 0.73, respectively. Furthermore, the relative risks of hypoglycemia per patient day and patient stay declined to 0.80 and 0.92, respectively, and the percentage of patient days with hypoglycemia decreased from 3.7% to 2.6%.

The findings are based on data from more than 5,500 subjects who had at least seven glucose measures during stays at the UCSD center. Data were compared for the year before the institution of the order set, for 18 months after introduction of the order set alone, and for the subsequent 8 months after the algorithm was added to the order set.

The success of the order set and the one-page algorithm—which recommended treatment pathways for adult medical and surgical inpatients who had a diagnosis of diabetes or documented hyperglycemia—were reported at the annual meeting of the Society of Hospital Medicine by Dr. Greg Maynard, chief of the division of hospital medicine at UCSD. The pathways were tailored to whether inpatients were receiving regular meals, were under NPO (nothing by mouth) orders, or were tube fed.

The outcomes were a “win-win situation,” he said. The “chaotic swings” in glycemia seen before the order set was instituted gave way to better control, and no special team was needed to get the results. He attributed most of the good results to a shift to basal/bolus insulin regimens from sliding-scale insulin regimens. After the order set and algorithm were instituted, sliding-scale-only insulin regimens decreased from 72% of 477 insulin regimens to 26% of 499 insulin regimens.

The next step for inpatient diabetes research, according to Dr. Maynard, is to develop reaction and prevention protocols. Suboptimal response to episodes of hyper- and hypoglycemia is the norm in hospitals, he said. “We don't take action when it should be taken, and opportunities to prevent hypoglycemia are missed.”

As an example, Dr. Maynard discussed the results of a study published last year. Within 48 hours after they were given an antihyperglycemic agent, 10% of 2,174 hospitalized patients with diabetes had hypoglycemia. Of those 206 patients, 44% had more than one hypoglycemic event. No adverse events accompanied 464 of the hypoglycemic episodes; there were 20 adverse events and 10 of these resulted in seizures or loss of consciousness. None of the adverse events was attributable to medication errors, and just 11% of the patients were on oral-only regimens.

About half of the hypoglycemic events were associated with reductions in enteral intake, but the precipitating factors were unclear in the other half. Just one-third of patients had their blood glucose rechecked within 60 minutes and fewer than half had documented euglycemia within 2 hours of their hypoglycemia; the average time to a documented resolution was 4 hours (J. Hosp. Med. 2007;2:234-40).

Dr. Maynard also advised examining patients' outpatient diabetes regimens, and imparted some recommendations for transitioning patients at hospital discharge.

The patient who was taking metformin and was admitted with a hemoglobin A_1c level greater than 9% and a baseline glucose measure of more than 350 mg/dL clearly needs her regimen adjusted, he said. But any recommendations need to consider her physical limitations; any new comorbidities; her willingness and ability to self-monitor; treatment goals; hypoglycemia risk factors; and the patient's financial situation. “You're not going to shoot for [a blood glucose level of] 110 mg/dL in a hospice patient, or encourage self-monitoring four times per day in a patient who can't afford it or is unwilling to do the tests,” he said. Those considerations weigh into treatment selection.

Dr. Maynard offered the following general observations to consider when you select a discharge therapy.

▸ Once HbA_1c exceeds 8.5%, additional oral agents are unlikely to achieve goals.

▸ Insulin at bedtime is a good initial strategy.

▸ Testing drives the cost of therapy. Testing four times per day is more expensive than insulin.

▸ Elderly patients are at higher risk for hypoglycemia. Decrease their insulin as they get better, and make sure they have good follow-up and aren't being overtreated.

▸ Glyburide has been linked with a higher risk of hypoglycemia than has glipizide.

▸ The evidence on risk factors is imperfect, but be hesitant to start glitazones de novo.

As a treatment reference, Dr. Maynard suggested algorithms available at the Web site of the American Academy of Clinical Endocrinologists (www.aace.com/resources/igcrcwww.hospitalmedicine.org/ResourceRoomRedesign/GlycemicControl.cfm

Dr. Maynard reported that he and his coinvestigators had no disclosures related to the study.

SAN DIEGO — Insulin-use patterns and glycemic control improved, while episodes of hypoglycemia declined, among non-critical care patients with diabetes after structured insulin orders and an insulin management algorithm were added to the hospital order set at the University of California, San Diego Medical Center.

After the structured insulin order set was added, the relative risk of an inpatient stay decreased to 0.84 when the mean blood glucose level was greater than 180 mg/dL. With the order set plus the algorithm in place, the relative risks of an uncontrolled patient day and an uncontrolled patient stay declined to 0.77 and to 0.73, respectively. Furthermore, the relative risks of hypoglycemia per patient day and patient stay declined to 0.80 and 0.92, respectively, and the percentage of patient days with hypoglycemia decreased from 3.7% to 2.6%.

The findings are based on data from more than 5,500 subjects who had at least seven glucose measures during stays at the UCSD center. Data were compared for the year before the institution of the order set, for 18 months after introduction of the order set alone, and for the subsequent 8 months after the algorithm was added to the order set.

The success of the order set and the one-page algorithm—which recommended treatment pathways for adult medical and surgical inpatients who had a diagnosis of diabetes or documented hyperglycemia—were reported at the annual meeting of the Society of Hospital Medicine by Dr. Greg Maynard, chief of the division of hospital medicine at UCSD. The pathways were tailored to whether inpatients were receiving regular meals, were under NPO (nothing by mouth) orders, or were tube fed.

The outcomes were a “win-win situation,” he said. The “chaotic swings” in glycemia seen before the order set was instituted gave way to better control, and no special team was needed to get the results. He attributed most of the good results to a shift to basal/bolus insulin regimens from sliding-scale insulin regimens. After the order set and algorithm were instituted, sliding-scale-only insulin regimens decreased from 72% of 477 insulin regimens to 26% of 499 insulin regimens.

The next step for inpatient diabetes research, according to Dr. Maynard, is to develop reaction and prevention protocols. Suboptimal response to episodes of hyper- and hypoglycemia is the norm in hospitals, he said. “We don't take action when it should be taken, and opportunities to prevent hypoglycemia are missed.”

As an example, Dr. Maynard discussed the results of a study published last year. Within 48 hours after they were given an antihyperglycemic agent, 10% of 2,174 hospitalized patients with diabetes had hypoglycemia. Of those 206 patients, 44% had more than one hypoglycemic event. No adverse events accompanied 464 of the hypoglycemic episodes; there were 20 adverse events and 10 of these resulted in seizures or loss of consciousness. None of the adverse events was attributable to medication errors, and just 11% of the patients were on oral-only regimens.

About half of the hypoglycemic events were associated with reductions in enteral intake, but the precipitating factors were unclear in the other half. Just one-third of patients had their blood glucose rechecked within 60 minutes and fewer than half had documented euglycemia within 2 hours of their hypoglycemia; the average time to a documented resolution was 4 hours (J. Hosp. Med. 2007;2:234-40).

Dr. Maynard also advised examining patients' outpatient diabetes regimens, and imparted some recommendations for transitioning patients at hospital discharge.

The patient who was taking metformin and was admitted with a hemoglobin A_1c level greater than 9% and a baseline glucose measure of more than 350 mg/dL clearly needs her regimen adjusted, he said. But any recommendations need to consider her physical limitations; any new comorbidities; her willingness and ability to self-monitor; treatment goals; hypoglycemia risk factors; and the patient's financial situation. “You're not going to shoot for [a blood glucose level of] 110 mg/dL in a hospice patient, or encourage self-monitoring four times per day in a patient who can't afford it or is unwilling to do the tests,” he said. Those considerations weigh into treatment selection.

Dr. Maynard offered the following general observations to consider when you select a discharge therapy.

▸ Once HbA_1c exceeds 8.5%, additional oral agents are unlikely to achieve goals.

▸ Insulin at bedtime is a good initial strategy.

▸ Testing drives the cost of therapy. Testing four times per day is more expensive than insulin.

▸ Elderly patients are at higher risk for hypoglycemia. Decrease their insulin as they get better, and make sure they have good follow-up and aren't being overtreated.

▸ Glyburide has been linked with a higher risk of hypoglycemia than has glipizide.

▸ The evidence on risk factors is imperfect, but be hesitant to start glitazones de novo.

As a treatment reference, Dr. Maynard suggested algorithms available at the Web site of the American Academy of Clinical Endocrinologists (www.aace.com/resources/igcrcwww.hospitalmedicine.org/ResourceRoomRedesign/GlycemicControl.cfm

Dr. Maynard reported that he and his coinvestigators had no disclosures related to the study.

Editor Robin Turner contributed to this story.

Medicare costs for chronic disease care at the end of life differed nearly twofold among the nation's “top five” academic medical centers as rated by U.S. News & World Report.

The finding, derived from data in the Dartmouth Atlas of Health Care 2008 report “Tracking the Care of Patients with Severe Chronic Illness,” convincingly argues that providing more services isn't necessary for providing good care to these patients, according to the report's authors.

Their broader analysis examined 2001–2005 data from Medicare's 306 hospital referral regions, and was limited to services provided in the last 2 years of life for all enrollees with any of nine severe chronic diseases. Chronic heart failure, cancer, and chronic obstructive pulmonary disease were the leading chronic diseases. Costs and services were evaluated for inpatient hospital care, outpatient services, skilled nursing and long-term hospital care, home health care, and hospice.

A high supply of available health care services encouraged more use of services, Dr. John E. Wennberg and his coauthors found. Paradoxically, the highest volume of services was perceived to be poorer care by both patients and physicians. The researchers attributed this inverse relationship to increased chances for errors, complications, miscommunications, and confusion about physician responsibilities for care as the volume of services increases.

Overall, 55% of total costs were for acute hospital care. The next largest fraction of spending (nearly 16%) was for outpatient care. The availability of alternative care—skilled nursing, rehab facilities, home health care, and hospices—did not necessarily lead to declines in hospitalizations or inpatient spending. Instead, admission to hospitals increased demand for discharge to other care sectors.

In regions with the most supply-sensitive care, patients spent nearly 22 days as inpatients and averaged almost 60 physician visits during their last 6 months of life. In areas with the least supply-sensitive care, patients spent about 6 days in hospitals and averaged 15 physician visits in their last 6 months.

To address the relationship between quality of care and cost of care, the authors took the novel approach of comparing Medicare spending and the availability and utilization of resources at the nation's top five academic medical centers. At the University of California, Los Angeles, Medical Center, Medicare spent more than $93,000 per chronically ill patient in the last 2 years of life. At the Mayo Clinic, Rochester, Minn., and the Cleveland Clinic, the costs were about $53,000 and $55,000. Johns Hopkins Hospital, Baltimore, and Massachusetts General Hospital, Boston, ranked second and third in total Medicare spending.

As in the larger analysis, the differences in spending at the top five centers were mainly driven by the supply of services. Compared with the other four centers, UCLA Medical Center has proportionately the highest numbers of physicians, hospital beds, ICU beds, and imaging and other services. Again, most of the differences in cost were in acute care; for example, 50% more days spent in the hospital in the last 6 months of life by patients at UCLA (18.5 days), compared with those at the Mayo Clinic (12 days).

The authors credited the group practice model and coordination of care at the Cleveland Clinic and Mayo Clinic with the cost savings.

Benchmarking based on practices at efficient centers can then be used to calculate potential savings by reducing overuse of supply-sensitive services at high-cost centers.

The Dartmouth findings come as no surprise to emergency physicians, said Dr. Brent Asplin, head of emergency medicine at Regions Hospital and HealthPartners Medical Group in St. Paul, Minn. “The emergency department has a view of what's going on in the broader health care system. We see the revolving door of repeat hospitalizations and emergency department visits for patients with poorly managed chronic disease.

“When you reward providers based on the volume of services, you will see higher utilization in areas with more providers. We need to work toward a system that rewards value rather than volume,” he said.

“One of the keys for addressing the wide variation in services is to restructure the way primary care is organized so there is a coordinated team to manage patients with chronic disease,” Dr. Asplin said.

“Ultimately, we cannot hospitalize our way to better health,” Dr. Asplin said “It is much easier to send a patient with chronic disease home from the ED when you know there is a primary care team that will pick up that patient the next day.”

Dr. Frank Michota, founder of the Cleveland Clinic's hospital medicine program, said the hospital strives for appropriate utilization by identifying “the hospitalization goal for each chronically ill patient who is admitted and driving the care plan to meet specific objectives.”

“We have no illusions that we will make a chronically ill patient normal again, but our default position is to treat aggressively until it is clear that no reversible pathology exists,” he said, adding, “Full discussion with the patient or family on the feasibility or likelihood of achieving the goal is also important.” Futile care plans are not undertaken just because that is what the patient or family wants.

The report authors recommended research on how treatments affect outcomes, patients' lives, and the efficiency of clinical practice.

Evidence is lacking for how often to see patients, when to refer to specialists, and when to admit. As a result, primary care physicians will refer to a specialist or admit to a hospital if those resources are available and payments for office-based care are constrained, they said.

Patients need to be followed over time and across settings by established group practices and integrated provider systems that are capable of organizing care over the span of an individual's chronic illness. Organizations that participate in this research should be rewarded through a proposed shared-savings program with the Centers for Medicare and Medicaid Services that is designed to encourage coordination and to reduce overuse of care, they proposed.

Physician groups and hospitals should be encouraged to become real or virtual integrated systems that are willing to be accountable for the coordination, overall costs, and quality of care provided to chronic disease patients.

The authors proposed a shared-savings approach in which payments are based on per-beneficiary costs relative to appropriate spending targets. Shared savings would allow physicians and hospitals to preserve their net incomes while reducing total revenues resulting from unnecessary care and overuse of acute care hospitals.

In addition to the Robert Wood Johnson Foundation, other supporters of the Dartmouth Atlas project include the WellPoint Foundation, Aetna Foundation, United Health Foundation, and California Healthcare Foundation. The full report is at www.dartmouthatlas.org

Editor Robin Turner contributed to this story.

Medicare costs for chronic disease care at the end of life differed nearly twofold among the nation's “top five” academic medical centers as rated by U.S. News & World Report.

The finding, derived from data in the Dartmouth Atlas of Health Care 2008 report “Tracking the Care of Patients with Severe Chronic Illness,” convincingly argues that providing more services isn't necessary for providing good care to these patients, according to the report's authors.

Their broader analysis examined 2001–2005 data from Medicare's 306 hospital referral regions, and was limited to services provided in the last 2 years of life for all enrollees with any of nine severe chronic diseases. Chronic heart failure, cancer, and chronic obstructive pulmonary disease were the leading chronic diseases. Costs and services were evaluated for inpatient hospital care, outpatient services, skilled nursing and long-term hospital care, home health care, and hospice.

A high supply of available health care services encouraged more use of services, Dr. John E. Wennberg and his coauthors found. Paradoxically, the highest volume of services was perceived to be poorer care by both patients and physicians. The researchers attributed this inverse relationship to increased chances for errors, complications, miscommunications, and confusion about physician responsibilities for care as the volume of services increases.

Overall, 55% of total costs were for acute hospital care. The next largest fraction of spending (nearly 16%) was for outpatient care. The availability of alternative care—skilled nursing, rehab facilities, home health care, and hospices—did not necessarily lead to declines in hospitalizations or inpatient spending. Instead, admission to hospitals increased demand for discharge to other care sectors.

In regions with the most supply-sensitive care, patients spent nearly 22 days as inpatients and averaged almost 60 physician visits during their last 6 months of life. In areas with the least supply-sensitive care, patients spent about 6 days in hospitals and averaged 15 physician visits in their last 6 months.

To address the relationship between quality of care and cost of care, the authors took the novel approach of comparing Medicare spending and the availability and utilization of resources at the nation's top five academic medical centers. At the University of California, Los Angeles, Medical Center, Medicare spent more than $93,000 per chronically ill patient in the last 2 years of life. At the Mayo Clinic, Rochester, Minn., and the Cleveland Clinic, the costs were about $53,000 and $55,000. Johns Hopkins Hospital, Baltimore, and Massachusetts General Hospital, Boston, ranked second and third in total Medicare spending.

As in the larger analysis, the differences in spending at the top five centers were mainly driven by the supply of services. Compared with the other four centers, UCLA Medical Center has proportionately the highest numbers of physicians, hospital beds, ICU beds, and imaging and other services. Again, most of the differences in cost were in acute care; for example, 50% more days spent in the hospital in the last 6 months of life by patients at UCLA (18.5 days), compared with those at the Mayo Clinic (12 days).

The authors credited the group practice model and coordination of care at the Cleveland Clinic and Mayo Clinic with the cost savings.

Benchmarking based on practices at efficient centers can then be used to calculate potential savings by reducing overuse of supply-sensitive services at high-cost centers.

The Dartmouth findings come as no surprise to emergency physicians, said Dr. Brent Asplin, head of emergency medicine at Regions Hospital and HealthPartners Medical Group in St. Paul, Minn. “The emergency department has a view of what's going on in the broader health care system. We see the revolving door of repeat hospitalizations and emergency department visits for patients with poorly managed chronic disease.

“When you reward providers based on the volume of services, you will see higher utilization in areas with more providers. We need to work toward a system that rewards value rather than volume,” he said.

“One of the keys for addressing the wide variation in services is to restructure the way primary care is organized so there is a coordinated team to manage patients with chronic disease,” Dr. Asplin said.

“Ultimately, we cannot hospitalize our way to better health,” Dr. Asplin said “It is much easier to send a patient with chronic disease home from the ED when you know there is a primary care team that will pick up that patient the next day.”

Dr. Frank Michota, founder of the Cleveland Clinic's hospital medicine program, said the hospital strives for appropriate utilization by identifying “the hospitalization goal for each chronically ill patient who is admitted and driving the care plan to meet specific objectives.”

“We have no illusions that we will make a chronically ill patient normal again, but our default position is to treat aggressively until it is clear that no reversible pathology exists,” he said, adding, “Full discussion with the patient or family on the feasibility or likelihood of achieving the goal is also important.” Futile care plans are not undertaken just because that is what the patient or family wants.

The report authors recommended research on how treatments affect outcomes, patients' lives, and the efficiency of clinical practice.

Evidence is lacking for how often to see patients, when to refer to specialists, and when to admit. As a result, primary care physicians will refer to a specialist or admit to a hospital if those resources are available and payments for office-based care are constrained, they said.

Patients need to be followed over time and across settings by established group practices and integrated provider systems that are capable of organizing care over the span of an individual's chronic illness. Organizations that participate in this research should be rewarded through a proposed shared-savings program with the Centers for Medicare and Medicaid Services that is designed to encourage coordination and to reduce overuse of care, they proposed.

Physician groups and hospitals should be encouraged to become real or virtual integrated systems that are willing to be accountable for the coordination, overall costs, and quality of care provided to chronic disease patients.

The authors proposed a shared-savings approach in which payments are based on per-beneficiary costs relative to appropriate spending targets. Shared savings would allow physicians and hospitals to preserve their net incomes while reducing total revenues resulting from unnecessary care and overuse of acute care hospitals.

In addition to the Robert Wood Johnson Foundation, other supporters of the Dartmouth Atlas project include the WellPoint Foundation, Aetna Foundation, United Health Foundation, and California Healthcare Foundation. The full report is at www.dartmouthatlas.org

Editor Robin Turner contributed to this story.

Medicare costs for chronic disease care at the end of life differed nearly twofold among the nation's “top five” academic medical centers as rated by U.S. News & World Report.

The finding, derived from data in the Dartmouth Atlas of Health Care 2008 report “Tracking the Care of Patients with Severe Chronic Illness,” convincingly argues that providing more services isn't necessary for providing good care to these patients, according to the report's authors.

Their broader analysis examined 2001–2005 data from Medicare's 306 hospital referral regions, and was limited to services provided in the last 2 years of life for all enrollees with any of nine severe chronic diseases. Chronic heart failure, cancer, and chronic obstructive pulmonary disease were the leading chronic diseases. Costs and services were evaluated for inpatient hospital care, outpatient services, skilled nursing and long-term hospital care, home health care, and hospice.

A high supply of available health care services encouraged more use of services, Dr. John E. Wennberg and his coauthors found. Paradoxically, the highest volume of services was perceived to be poorer care by both patients and physicians. The researchers attributed this inverse relationship to increased chances for errors, complications, miscommunications, and confusion about physician responsibilities for care as the volume of services increases.

Overall, 55% of total costs were for acute hospital care. The next largest fraction of spending (nearly 16%) was for outpatient care. The availability of alternative care—skilled nursing, rehab facilities, home health care, and hospices—did not necessarily lead to declines in hospitalizations or inpatient spending. Instead, admission to hospitals increased demand for discharge to other care sectors.

In regions with the most supply-sensitive care, patients spent nearly 22 days as inpatients and averaged almost 60 physician visits during their last 6 months of life. In areas with the least supply-sensitive care, patients spent about 6 days in hospitals and averaged 15 physician visits in their last 6 months.

To address the relationship between quality of care and cost of care, the authors took the novel approach of comparing Medicare spending and the availability and utilization of resources at the nation's top five academic medical centers. At the University of California, Los Angeles, Medical Center, Medicare spent more than $93,000 per chronically ill patient in the last 2 years of life. At the Mayo Clinic, Rochester, Minn., and the Cleveland Clinic, the costs were about $53,000 and $55,000. Johns Hopkins Hospital, Baltimore, and Massachusetts General Hospital, Boston, ranked second and third in total Medicare spending.

As in the larger analysis, the differences in spending at the top five centers were mainly driven by the supply of services. Compared with the other four centers, UCLA Medical Center has proportionately the highest numbers of physicians, hospital beds, ICU beds, and imaging and other services. Again, most of the differences in cost were in acute care; for example, 50% more days spent in the hospital in the last 6 months of life by patients at UCLA (18.5 days), compared with those at the Mayo Clinic (12 days).

The authors credited the group practice model and coordination of care at the Cleveland Clinic and Mayo Clinic with the cost savings.

Benchmarking based on practices at efficient centers can then be used to calculate potential savings by reducing overuse of supply-sensitive services at high-cost centers.

The Dartmouth findings come as no surprise to emergency physicians, said Dr. Brent Asplin, head of emergency medicine at Regions Hospital and HealthPartners Medical Group in St. Paul, Minn. “The emergency department has a view of what's going on in the broader health care system. We see the revolving door of repeat hospitalizations and emergency department visits for patients with poorly managed chronic disease.

“When you reward providers based on the volume of services, you will see higher utilization in areas with more providers. We need to work toward a system that rewards value rather than volume,” he said.

“One of the keys for addressing the wide variation in services is to restructure the way primary care is organized so there is a coordinated team to manage patients with chronic disease,” Dr. Asplin said.

“Ultimately, we cannot hospitalize our way to better health,” Dr. Asplin said “It is much easier to send a patient with chronic disease home from the ED when you know there is a primary care team that will pick up that patient the next day.”

Dr. Frank Michota, founder of the Cleveland Clinic's hospital medicine program, said the hospital strives for appropriate utilization by identifying “the hospitalization goal for each chronically ill patient who is admitted and driving the care plan to meet specific objectives.”

“We have no illusions that we will make a chronically ill patient normal again, but our default position is to treat aggressively until it is clear that no reversible pathology exists,” he said, adding, “Full discussion with the patient or family on the feasibility or likelihood of achieving the goal is also important.” Futile care plans are not undertaken just because that is what the patient or family wants.

The report authors recommended research on how treatments affect outcomes, patients' lives, and the efficiency of clinical practice.

Evidence is lacking for how often to see patients, when to refer to specialists, and when to admit. As a result, primary care physicians will refer to a specialist or admit to a hospital if those resources are available and payments for office-based care are constrained, they said.

Patients need to be followed over time and across settings by established group practices and integrated provider systems that are capable of organizing care over the span of an individual's chronic illness. Organizations that participate in this research should be rewarded through a proposed shared-savings program with the Centers for Medicare and Medicaid Services that is designed to encourage coordination and to reduce overuse of care, they proposed.

Physician groups and hospitals should be encouraged to become real or virtual integrated systems that are willing to be accountable for the coordination, overall costs, and quality of care provided to chronic disease patients.

The authors proposed a shared-savings approach in which payments are based on per-beneficiary costs relative to appropriate spending targets. Shared savings would allow physicians and hospitals to preserve their net incomes while reducing total revenues resulting from unnecessary care and overuse of acute care hospitals.

In addition to the Robert Wood Johnson Foundation, other supporters of the Dartmouth Atlas project include the WellPoint Foundation, Aetna Foundation, United Health Foundation, and California Healthcare Foundation. The full report is at www.dartmouthatlas.org

CHICAGO — Men have more mild cognitive impairment than women do, yet there is no gender difference in the prevalence of dementia, according to the results of one of the first studies to measure mild cognitive impairment prospectively in a population-based setting.

The findings, reported by Dr. Rosebud O. Roberts at the annual meeting of the American Academy of Neurology, suggest that dementia progresses either faster in women or slower in men.

For the ongoing study, called the Mayo Clinic Study of Aging, mild cognitive impairment (MCI) was evaluated in a population sample from Olmstead County, Minn. The 70- to 79-year-old group included 490 women and 596 men. The 80- to 89-year-old group included 512 women and 452 men. For both age groups, there were 1,002 women and 1,048 men.

A nurse, physician, or neuropsychologist evaluated each individual using face-to-face measures. Subjects were evaluated in four domains—memory, executive function, language, and visual/spatial skills. MCI was defined as impairment in one or more domains or an overall mild decline across cognitive abilities that is greater than would be expected for an individual's age or education but is insufficient to interfere with social and occupational functioning.

Based on these evaluations, 74% of the group had normal cognition, 16% had MCI, and 10% had dementia. Of the nearly 2,000 study participants without dementia, 51% were male, 47% had less than 12 years of education, 52% were 80–89 years old, and 61% were married.

Subjects were studied prospectively beginning in October 2004 and follow-ups will continue through 2010. This differs from most other studies of MCI, which had the limitations of applying MCI criteria to previously collected data or were conducted in study samples, such as those attending memory clinics, who might not be representative of the general population.

In men, the prevalence of mild cognitive impairment steadily increased from about 10% at age 70 and suddenly spiked after age 85 to affect 40%. In women, the rate rose more slowly and the prevalence was far lower, peaking at less than 20% at age 85.

Even after the data were corrected for age plus education, marital status, and disease burden, women had less cognitive impairment but comparable rates of dementia, compared with men, Dr. Roberts said.

“We found the overall prevalence of mild cognitive impairment is quite high—over 16%,” said Dr. Roberts. “But perhaps the more surprising finding is the higher prevalence of MCI in men with the comparable prevalence of dementia for men and women.” Several possible explanations for this disparity include a prevalence of risk factors in middle age vs. later life, the progression rate from MCI to dementia, and death among persons with MCI.

Dr. Roberts said that she and her coinvestigators are in the process of adding another 1,000 participants to continue the follow-up study. The study was supported by the National Institutes of Health and the Robert H. and Clarice Smith and Abigail Van Buren Alzheimer's Disease Research Program.

CHICAGO — Men have more mild cognitive impairment than women do, yet there is no gender difference in the prevalence of dementia, according to the results of one of the first studies to measure mild cognitive impairment prospectively in a population-based setting.

The findings, reported by Dr. Rosebud O. Roberts at the annual meeting of the American Academy of Neurology, suggest that dementia progresses either faster in women or slower in men.

For the ongoing study, called the Mayo Clinic Study of Aging, mild cognitive impairment (MCI) was evaluated in a population sample from Olmstead County, Minn. The 70- to 79-year-old group included 490 women and 596 men. The 80- to 89-year-old group included 512 women and 452 men. For both age groups, there were 1,002 women and 1,048 men.

A nurse, physician, or neuropsychologist evaluated each individual using face-to-face measures. Subjects were evaluated in four domains—memory, executive function, language, and visual/spatial skills. MCI was defined as impairment in one or more domains or an overall mild decline across cognitive abilities that is greater than would be expected for an individual's age or education but is insufficient to interfere with social and occupational functioning.

Based on these evaluations, 74% of the group had normal cognition, 16% had MCI, and 10% had dementia. Of the nearly 2,000 study participants without dementia, 51% were male, 47% had less than 12 years of education, 52% were 80–89 years old, and 61% were married.

Subjects were studied prospectively beginning in October 2004 and follow-ups will continue through 2010. This differs from most other studies of MCI, which had the limitations of applying MCI criteria to previously collected data or were conducted in study samples, such as those attending memory clinics, who might not be representative of the general population.

In men, the prevalence of mild cognitive impairment steadily increased from about 10% at age 70 and suddenly spiked after age 85 to affect 40%. In women, the rate rose more slowly and the prevalence was far lower, peaking at less than 20% at age 85.

Even after the data were corrected for age plus education, marital status, and disease burden, women had less cognitive impairment but comparable rates of dementia, compared with men, Dr. Roberts said.

“We found the overall prevalence of mild cognitive impairment is quite high—over 16%,” said Dr. Roberts. “But perhaps the more surprising finding is the higher prevalence of MCI in men with the comparable prevalence of dementia for men and women.” Several possible explanations for this disparity include a prevalence of risk factors in middle age vs. later life, the progression rate from MCI to dementia, and death among persons with MCI.

Dr. Roberts said that she and her coinvestigators are in the process of adding another 1,000 participants to continue the follow-up study. The study was supported by the National Institutes of Health and the Robert H. and Clarice Smith and Abigail Van Buren Alzheimer's Disease Research Program.

CHICAGO — Men have more mild cognitive impairment than women do, yet there is no gender difference in the prevalence of dementia, according to the results of one of the first studies to measure mild cognitive impairment prospectively in a population-based setting.

The findings, reported by Dr. Rosebud O. Roberts at the annual meeting of the American Academy of Neurology, suggest that dementia progresses either faster in women or slower in men.

For the ongoing study, called the Mayo Clinic Study of Aging, mild cognitive impairment (MCI) was evaluated in a population sample from Olmstead County, Minn. The 70- to 79-year-old group included 490 women and 596 men. The 80- to 89-year-old group included 512 women and 452 men. For both age groups, there were 1,002 women and 1,048 men.

A nurse, physician, or neuropsychologist evaluated each individual using face-to-face measures. Subjects were evaluated in four domains—memory, executive function, language, and visual/spatial skills. MCI was defined as impairment in one or more domains or an overall mild decline across cognitive abilities that is greater than would be expected for an individual's age or education but is insufficient to interfere with social and occupational functioning.

Based on these evaluations, 74% of the group had normal cognition, 16% had MCI, and 10% had dementia. Of the nearly 2,000 study participants without dementia, 51% were male, 47% had less than 12 years of education, 52% were 80–89 years old, and 61% were married.

Subjects were studied prospectively beginning in October 2004 and follow-ups will continue through 2010. This differs from most other studies of MCI, which had the limitations of applying MCI criteria to previously collected data or were conducted in study samples, such as those attending memory clinics, who might not be representative of the general population.

In men, the prevalence of mild cognitive impairment steadily increased from about 10% at age 70 and suddenly spiked after age 85 to affect 40%. In women, the rate rose more slowly and the prevalence was far lower, peaking at less than 20% at age 85.

Even after the data were corrected for age plus education, marital status, and disease burden, women had less cognitive impairment but comparable rates of dementia, compared with men, Dr. Roberts said.

“We found the overall prevalence of mild cognitive impairment is quite high—over 16%,” said Dr. Roberts. “But perhaps the more surprising finding is the higher prevalence of MCI in men with the comparable prevalence of dementia for men and women.” Several possible explanations for this disparity include a prevalence of risk factors in middle age vs. later life, the progression rate from MCI to dementia, and death among persons with MCI.

Dr. Roberts said that she and her coinvestigators are in the process of adding another 1,000 participants to continue the follow-up study. The study was supported by the National Institutes of Health and the Robert H. and Clarice Smith and Abigail Van Buren Alzheimer's Disease Research Program.