Doug Brunk

PALM SPRINGS, CALIF. — Routine medical care and comprehensive health insurance coverage seem to improve the early detection of epithelial ovarian cancer in women aged 59 and younger, but not in those aged 60 and older, Dr. Sherry H. Weitzen reported in a poster session at the annual meeting of the Society of Gynecologic Oncologists.

“It surprised me that there was very little effect of access to care for older women in terms of being diagnosed at an earlier stage,” Dr. Weitzen, an epidemiologist in the obstetrics and gynecology department at Brown University, Providence, R.I., said in an interview. “I was disappointed because … it seems like older women are doomed to being diagnosed later. That's what the literature says anyway, and there seems to be no kind of help for them [even] if they are vigilant about their health care.”

Dr. Weitzen and her associates reviewed the medical charts of 832 women diagnosed with epithelial ovarian cancer at Women and Infants Hospital in Providence between 1991 and 2004. They used International Federation of Gynecology and Obstetrics (FIGO) standards to determine tumor stage during or after surgery, and defined health insurance as private/Medicare and Medicaid/uninsured/self-pay/none documented. Of the 832 women, most (540) were diagnosed with late-stage disease, 82% were insured by Medicare or private insurance plans, and 66% reported having a “usual” care provider.

Of the 292 women diagnosed with early-stage disease, 71% reported having routine medical care, compared with 63% of their counterparts diagnosed with late-stage disease. In addition, 85% of women with early-stage disease had Medicare or private insurance, compared with 80% of women diagnosed with late-stage disease.

After adjusting for age at diagnosis, the researchers found that women who had routine medical care plus Medicare and/or private insurance were 1.74 times more likely to have ovarian cancer diagnosed at an early stage, compared with those who had no routine care and no other insurance plans.

“For women less than 60 years of age, the combined effect of having both routine care and better health insurance had two times the odds of earlier diagnosis, compared to women with no routine care and other health insurance,” the researchers wrote in their poster.

PALM SPRINGS, CALIF. — Routine medical care and comprehensive health insurance coverage seem to improve the early detection of epithelial ovarian cancer in women aged 59 and younger, but not in those aged 60 and older, Dr. Sherry H. Weitzen reported in a poster session at the annual meeting of the Society of Gynecologic Oncologists.

“It surprised me that there was very little effect of access to care for older women in terms of being diagnosed at an earlier stage,” Dr. Weitzen, an epidemiologist in the obstetrics and gynecology department at Brown University, Providence, R.I., said in an interview. “I was disappointed because … it seems like older women are doomed to being diagnosed later. That's what the literature says anyway, and there seems to be no kind of help for them [even] if they are vigilant about their health care.”

Dr. Weitzen and her associates reviewed the medical charts of 832 women diagnosed with epithelial ovarian cancer at Women and Infants Hospital in Providence between 1991 and 2004. They used International Federation of Gynecology and Obstetrics (FIGO) standards to determine tumor stage during or after surgery, and defined health insurance as private/Medicare and Medicaid/uninsured/self-pay/none documented. Of the 832 women, most (540) were diagnosed with late-stage disease, 82% were insured by Medicare or private insurance plans, and 66% reported having a “usual” care provider.

Of the 292 women diagnosed with early-stage disease, 71% reported having routine medical care, compared with 63% of their counterparts diagnosed with late-stage disease. In addition, 85% of women with early-stage disease had Medicare or private insurance, compared with 80% of women diagnosed with late-stage disease.

After adjusting for age at diagnosis, the researchers found that women who had routine medical care plus Medicare and/or private insurance were 1.74 times more likely to have ovarian cancer diagnosed at an early stage, compared with those who had no routine care and no other insurance plans.

“For women less than 60 years of age, the combined effect of having both routine care and better health insurance had two times the odds of earlier diagnosis, compared to women with no routine care and other health insurance,” the researchers wrote in their poster.

PALM SPRINGS, CALIF. — Routine medical care and comprehensive health insurance coverage seem to improve the early detection of epithelial ovarian cancer in women aged 59 and younger, but not in those aged 60 and older, Dr. Sherry H. Weitzen reported in a poster session at the annual meeting of the Society of Gynecologic Oncologists.

“It surprised me that there was very little effect of access to care for older women in terms of being diagnosed at an earlier stage,” Dr. Weitzen, an epidemiologist in the obstetrics and gynecology department at Brown University, Providence, R.I., said in an interview. “I was disappointed because … it seems like older women are doomed to being diagnosed later. That's what the literature says anyway, and there seems to be no kind of help for them [even] if they are vigilant about their health care.”

Dr. Weitzen and her associates reviewed the medical charts of 832 women diagnosed with epithelial ovarian cancer at Women and Infants Hospital in Providence between 1991 and 2004. They used International Federation of Gynecology and Obstetrics (FIGO) standards to determine tumor stage during or after surgery, and defined health insurance as private/Medicare and Medicaid/uninsured/self-pay/none documented. Of the 832 women, most (540) were diagnosed with late-stage disease, 82% were insured by Medicare or private insurance plans, and 66% reported having a “usual” care provider.

Of the 292 women diagnosed with early-stage disease, 71% reported having routine medical care, compared with 63% of their counterparts diagnosed with late-stage disease. In addition, 85% of women with early-stage disease had Medicare or private insurance, compared with 80% of women diagnosed with late-stage disease.

After adjusting for age at diagnosis, the researchers found that women who had routine medical care plus Medicare and/or private insurance were 1.74 times more likely to have ovarian cancer diagnosed at an early stage, compared with those who had no routine care and no other insurance plans.

“For women less than 60 years of age, the combined effect of having both routine care and better health insurance had two times the odds of earlier diagnosis, compared to women with no routine care and other health insurance,” the researchers wrote in their poster.

SAN DIEGO — Healthy women aged 45 years and older who have migraine with aura have a significantly increased risk of coronary heart disease, myocardial infarction, coronary revascularization, and angina, results from the largest study of its kind demonstrated.

On the other hand, migraine without aura was not associated with any such outcome, Dr. Tobias Kurth reported at the annual meeting of the American Academy of Neurology.

“Since migraine without aura is far more common than migraine with aura, for most migraine patients our data indicate no increased risk for coronary heart disease,” said Dr. Kurth of the division of preventive medicine at Brigham and Women's Hospital, Boston. And, “since the precise mechanism by which migraine may lead to coronary heart disease is currently unknown, it likely reflects future research focus on potential biological explanations.”

Dr. Richard B. Lipton, who was invited to discuss the work, said the findings warrant being vigilant for coronary heart disease (CHD) risk factors in all patients who have migraine with aura.

This would include working with patients to modify CHD risk factors “and to acknowledge that those risk factors are more powerful than migraine with aura itself,” noted Dr. Lipton, vice chair of neurology at Albert Einstein College of Medicine, New York. “On a long-term basis it may be possible to devise risk factor modification strategies that might include aspirin or folate.”

In a study funded by the National Institutes of Health, Dr. Kurth and his associates followed 27,840 women aged 45 years and older who were enrolled in the Women's Health Study. All study participants were free of cardiovascular disease at baseline.

The researchers used a Cox proportional hazards model to evaluate the association between migraine and risk of subsequent CHD and angina, while adjusting for several cardiovascular risk factors including age, blood pressure, smoking status, body mass index, alcohol consumption, and exercise habits. The average follow-up was 10 years.

In the baseline questionnaire study, participants were asked if they ever had a migraine, and if they had a migraine in the previous year. “If the woman answered yes to the latter question, we asked further details about her migraine, including a question about aura,” Dr. Kurth said.

Women who did not report migraine served as the referent group. At baseline, 5,125 (18%) reported a history of migraine and 3,610 (13%) reported current migraine. Of those who reported current migraine, 1,434 (40%) reported aura. During 10 years of follow-up, 625 coronary heart disease events and 408 angina events occurred.

Compared with women who reported no history of migraine, women who reported migraine with aura had a 1.7-fold increased risk for CHD; a 2-fold increased risk for myocardial infarction; a 1.7-fold increased risk for coronary revascularization, and a 1.7-fold increased risk for angina. On average, the risk for all of these factors reached statistical significance in the sixth year of follow-up, said Dr. Kurth, also of Harvard Medical School, Boston. Migraineurs without aura had no increased risk for any of the outcome events.

“Our study has several strengths, including its large number of participants, long follow-up, prospective design, use of a standardized questionnaire, and the rigorous nature of the cohort,” Dr. Kurth said. “All outcome events were confirmed [after medical record review] with the exception of angina.”

Study imitations were that migraine with aura was self-reported and that there was no information on migraine-specific drug use. “With regard to generalizability, all women were age 45 or older, health professionals, and mostly white,” he added. “However, based on current knowledge, it's unlikely that the association between migraine and coronary heart disease is different in other female populations.”

SAN DIEGO — Healthy women aged 45 years and older who have migraine with aura have a significantly increased risk of coronary heart disease, myocardial infarction, coronary revascularization, and angina, results from the largest study of its kind demonstrated.

On the other hand, migraine without aura was not associated with any such outcome, Dr. Tobias Kurth reported at the annual meeting of the American Academy of Neurology.

“Since migraine without aura is far more common than migraine with aura, for most migraine patients our data indicate no increased risk for coronary heart disease,” said Dr. Kurth of the division of preventive medicine at Brigham and Women's Hospital, Boston. And, “since the precise mechanism by which migraine may lead to coronary heart disease is currently unknown, it likely reflects future research focus on potential biological explanations.”

Dr. Richard B. Lipton, who was invited to discuss the work, said the findings warrant being vigilant for coronary heart disease (CHD) risk factors in all patients who have migraine with aura.

This would include working with patients to modify CHD risk factors “and to acknowledge that those risk factors are more powerful than migraine with aura itself,” noted Dr. Lipton, vice chair of neurology at Albert Einstein College of Medicine, New York. “On a long-term basis it may be possible to devise risk factor modification strategies that might include aspirin or folate.”

In a study funded by the National Institutes of Health, Dr. Kurth and his associates followed 27,840 women aged 45 years and older who were enrolled in the Women's Health Study. All study participants were free of cardiovascular disease at baseline.

The researchers used a Cox proportional hazards model to evaluate the association between migraine and risk of subsequent CHD and angina, while adjusting for several cardiovascular risk factors including age, blood pressure, smoking status, body mass index, alcohol consumption, and exercise habits. The average follow-up was 10 years.

In the baseline questionnaire study, participants were asked if they ever had a migraine, and if they had a migraine in the previous year. “If the woman answered yes to the latter question, we asked further details about her migraine, including a question about aura,” Dr. Kurth said.

Women who did not report migraine served as the referent group. At baseline, 5,125 (18%) reported a history of migraine and 3,610 (13%) reported current migraine. Of those who reported current migraine, 1,434 (40%) reported aura. During 10 years of follow-up, 625 coronary heart disease events and 408 angina events occurred.

Compared with women who reported no history of migraine, women who reported migraine with aura had a 1.7-fold increased risk for CHD; a 2-fold increased risk for myocardial infarction; a 1.7-fold increased risk for coronary revascularization, and a 1.7-fold increased risk for angina. On average, the risk for all of these factors reached statistical significance in the sixth year of follow-up, said Dr. Kurth, also of Harvard Medical School, Boston. Migraineurs without aura had no increased risk for any of the outcome events.

“Our study has several strengths, including its large number of participants, long follow-up, prospective design, use of a standardized questionnaire, and the rigorous nature of the cohort,” Dr. Kurth said. “All outcome events were confirmed [after medical record review] with the exception of angina.”

Study imitations were that migraine with aura was self-reported and that there was no information on migraine-specific drug use. “With regard to generalizability, all women were age 45 or older, health professionals, and mostly white,” he added. “However, based on current knowledge, it's unlikely that the association between migraine and coronary heart disease is different in other female populations.”

SAN DIEGO — Healthy women aged 45 years and older who have migraine with aura have a significantly increased risk of coronary heart disease, myocardial infarction, coronary revascularization, and angina, results from the largest study of its kind demonstrated.

On the other hand, migraine without aura was not associated with any such outcome, Dr. Tobias Kurth reported at the annual meeting of the American Academy of Neurology.

“Since migraine without aura is far more common than migraine with aura, for most migraine patients our data indicate no increased risk for coronary heart disease,” said Dr. Kurth of the division of preventive medicine at Brigham and Women's Hospital, Boston. And, “since the precise mechanism by which migraine may lead to coronary heart disease is currently unknown, it likely reflects future research focus on potential biological explanations.”

Dr. Richard B. Lipton, who was invited to discuss the work, said the findings warrant being vigilant for coronary heart disease (CHD) risk factors in all patients who have migraine with aura.

This would include working with patients to modify CHD risk factors “and to acknowledge that those risk factors are more powerful than migraine with aura itself,” noted Dr. Lipton, vice chair of neurology at Albert Einstein College of Medicine, New York. “On a long-term basis it may be possible to devise risk factor modification strategies that might include aspirin or folate.”

In a study funded by the National Institutes of Health, Dr. Kurth and his associates followed 27,840 women aged 45 years and older who were enrolled in the Women's Health Study. All study participants were free of cardiovascular disease at baseline.

The researchers used a Cox proportional hazards model to evaluate the association between migraine and risk of subsequent CHD and angina, while adjusting for several cardiovascular risk factors including age, blood pressure, smoking status, body mass index, alcohol consumption, and exercise habits. The average follow-up was 10 years.

In the baseline questionnaire study, participants were asked if they ever had a migraine, and if they had a migraine in the previous year. “If the woman answered yes to the latter question, we asked further details about her migraine, including a question about aura,” Dr. Kurth said.

Women who did not report migraine served as the referent group. At baseline, 5,125 (18%) reported a history of migraine and 3,610 (13%) reported current migraine. Of those who reported current migraine, 1,434 (40%) reported aura. During 10 years of follow-up, 625 coronary heart disease events and 408 angina events occurred.

Compared with women who reported no history of migraine, women who reported migraine with aura had a 1.7-fold increased risk for CHD; a 2-fold increased risk for myocardial infarction; a 1.7-fold increased risk for coronary revascularization, and a 1.7-fold increased risk for angina. On average, the risk for all of these factors reached statistical significance in the sixth year of follow-up, said Dr. Kurth, also of Harvard Medical School, Boston. Migraineurs without aura had no increased risk for any of the outcome events.

“Our study has several strengths, including its large number of participants, long follow-up, prospective design, use of a standardized questionnaire, and the rigorous nature of the cohort,” Dr. Kurth said. “All outcome events were confirmed [after medical record review] with the exception of angina.”

Study imitations were that migraine with aura was self-reported and that there was no information on migraine-specific drug use. “With regard to generalizability, all women were age 45 or older, health professionals, and mostly white,” he added. “However, based on current knowledge, it's unlikely that the association between migraine and coronary heart disease is different in other female populations.”

SAN DIEGO – Increased levels of C-reactive protein and other markers of perioperative inflammatory response are associated with neurocognitive decline following cardiac surgery, Dr. Basel Ramlawi said at a congress sponsored by the Association for Academic Surgery and the Society of University Surgeons.

Dr. Ramlawi and his associates prospectively evaluated 41 patients who underwent coronary artery bypass graft and/or valve procedures that used cardiopulmonary bypass. The patients' mean age was 67 years. All patients had neurocognitive testing preoperatively, postoperatively at day 4, and at 3 months. The validated tests took 45 minutes to administer and covered memory, executive function, naming, attention, fluency, and premorbid intelligence, said Dr. Ramlawi of the division of cardiothoracic surgery at Harvard Medical School, Boston. Neurocognitive decline was defined as performing one standard deviation from baseline on at least 25% of tasks.

Participants also underwent serum testing preoperatively, postoperatively at 6 hours, and at 4 days. Levels of C-reactive protein (CRP) and of interleukin 1β, IL-6, and IL-10 were assessed, and an increase of serum tau protein after surgery was used as a marker of axonal central nervous system damage.

Of the 41 patients, 7 (17%) developed neurocognitive decline. Baseline characteristics and predictors of neurocognitive decline such as age, education level, and perioperative temperature did not differ significantly between patients with and without postoperative neurocognitive decline.

However, patients who experienced postoperative neurocognitive decline had significantly greater increases of CRP, IL-1β, and IL-10 than those who had no decline.

In addition, the level of tau protein was increased 78% in patients with neurocognitive decline, compared with 29% in their counterparts who did not show a decline.

“There exists a significant association [between] the magnitude and persistence of the perioperative inflammatory response and neurocognitive decline in this cohort,” Dr. Ramlawi said. “This association is likely mediated by axonal damage.”

According to the medical literature, the incidence of neurocognitive decline is 20%–60% in the first 2 weeks after cardiac surgery. “It can range from 5% to 40% for periods up to 5 years after surgery,” he said, adding that the etiology of this complication is not known.

“It is likely a multifactorial problem,” Dr. Ramlawi said. “Several theories have been assessed. The most obvious one is ischemia. Any microemboli might cause this.”

Other possible factors include anesthesia, perioperative hypothermia, and low level of education.

“While there have been certain markers of brain injury following cardiopulmonary bypass, very few have been associated with clinical outcomes and neurocognitive decline,” he said. “Tau protein, on the other hand, assesses axonal damage and has not been [studied] in cardiac surgery before.”

SAN DIEGO – Increased levels of C-reactive protein and other markers of perioperative inflammatory response are associated with neurocognitive decline following cardiac surgery, Dr. Basel Ramlawi said at a congress sponsored by the Association for Academic Surgery and the Society of University Surgeons.

Dr. Ramlawi and his associates prospectively evaluated 41 patients who underwent coronary artery bypass graft and/or valve procedures that used cardiopulmonary bypass. The patients' mean age was 67 years. All patients had neurocognitive testing preoperatively, postoperatively at day 4, and at 3 months. The validated tests took 45 minutes to administer and covered memory, executive function, naming, attention, fluency, and premorbid intelligence, said Dr. Ramlawi of the division of cardiothoracic surgery at Harvard Medical School, Boston. Neurocognitive decline was defined as performing one standard deviation from baseline on at least 25% of tasks.

Participants also underwent serum testing preoperatively, postoperatively at 6 hours, and at 4 days. Levels of C-reactive protein (CRP) and of interleukin 1β, IL-6, and IL-10 were assessed, and an increase of serum tau protein after surgery was used as a marker of axonal central nervous system damage.

Of the 41 patients, 7 (17%) developed neurocognitive decline. Baseline characteristics and predictors of neurocognitive decline such as age, education level, and perioperative temperature did not differ significantly between patients with and without postoperative neurocognitive decline.

However, patients who experienced postoperative neurocognitive decline had significantly greater increases of CRP, IL-1β, and IL-10 than those who had no decline.

In addition, the level of tau protein was increased 78% in patients with neurocognitive decline, compared with 29% in their counterparts who did not show a decline.

“There exists a significant association [between] the magnitude and persistence of the perioperative inflammatory response and neurocognitive decline in this cohort,” Dr. Ramlawi said. “This association is likely mediated by axonal damage.”

According to the medical literature, the incidence of neurocognitive decline is 20%–60% in the first 2 weeks after cardiac surgery. “It can range from 5% to 40% for periods up to 5 years after surgery,” he said, adding that the etiology of this complication is not known.

“It is likely a multifactorial problem,” Dr. Ramlawi said. “Several theories have been assessed. The most obvious one is ischemia. Any microemboli might cause this.”

Other possible factors include anesthesia, perioperative hypothermia, and low level of education.

“While there have been certain markers of brain injury following cardiopulmonary bypass, very few have been associated with clinical outcomes and neurocognitive decline,” he said. “Tau protein, on the other hand, assesses axonal damage and has not been [studied] in cardiac surgery before.”

SAN DIEGO – Increased levels of C-reactive protein and other markers of perioperative inflammatory response are associated with neurocognitive decline following cardiac surgery, Dr. Basel Ramlawi said at a congress sponsored by the Association for Academic Surgery and the Society of University Surgeons.

Dr. Ramlawi and his associates prospectively evaluated 41 patients who underwent coronary artery bypass graft and/or valve procedures that used cardiopulmonary bypass. The patients' mean age was 67 years. All patients had neurocognitive testing preoperatively, postoperatively at day 4, and at 3 months. The validated tests took 45 minutes to administer and covered memory, executive function, naming, attention, fluency, and premorbid intelligence, said Dr. Ramlawi of the division of cardiothoracic surgery at Harvard Medical School, Boston. Neurocognitive decline was defined as performing one standard deviation from baseline on at least 25% of tasks.

Participants also underwent serum testing preoperatively, postoperatively at 6 hours, and at 4 days. Levels of C-reactive protein (CRP) and of interleukin 1β, IL-6, and IL-10 were assessed, and an increase of serum tau protein after surgery was used as a marker of axonal central nervous system damage.

Of the 41 patients, 7 (17%) developed neurocognitive decline. Baseline characteristics and predictors of neurocognitive decline such as age, education level, and perioperative temperature did not differ significantly between patients with and without postoperative neurocognitive decline.

However, patients who experienced postoperative neurocognitive decline had significantly greater increases of CRP, IL-1β, and IL-10 than those who had no decline.

In addition, the level of tau protein was increased 78% in patients with neurocognitive decline, compared with 29% in their counterparts who did not show a decline.

“There exists a significant association [between] the magnitude and persistence of the perioperative inflammatory response and neurocognitive decline in this cohort,” Dr. Ramlawi said. “This association is likely mediated by axonal damage.”

According to the medical literature, the incidence of neurocognitive decline is 20%–60% in the first 2 weeks after cardiac surgery. “It can range from 5% to 40% for periods up to 5 years after surgery,” he said, adding that the etiology of this complication is not known.

“It is likely a multifactorial problem,” Dr. Ramlawi said. “Several theories have been assessed. The most obvious one is ischemia. Any microemboli might cause this.”

Other possible factors include anesthesia, perioperative hypothermia, and low level of education.

“While there have been certain markers of brain injury following cardiopulmonary bypass, very few have been associated with clinical outcomes and neurocognitive decline,” he said. “Tau protein, on the other hand, assesses axonal damage and has not been [studied] in cardiac surgery before.”

SAN DIEGO — Most resident and attending physicians expressed ambivalence regarding the 80-hour workweek policy in a survey conducted by Dr. Thomas Esposito and his associates at Loyola University Medical Center in Maywood, Ill.

“The perceptions of both residents and attendings seem to suggest that the policy change may not yet be achieving its intended objectives,” Dr. Esposito reported at a congress sponsored by the Association for Academic Surgery and the Society of University Surgeons.

“It may actually be detrimental to attendings,” he added.

Studies comparing the views of resident and attending physicians regarding the 80-hour workweek policy for medical residents, implemented in July 2003 by the Accreditation Council for Graduate Medical Education, “are sparse, and studies comparing surgical and nonsurgical practitioners also have not routinely been done,” noted Dr. Esposito, professor of surgery at the university and head of the injury analysis and prevention program at the Loyola Burn and Shock Trauma Institute.

In an effort to determine how residents and attendings from surgical and nonsurgical fields felt about the policy, Dr. Esposito and his associates distributed an electronic survey in August and September 2004 to 375 faculty and 527 residents representing 26 graduate medical education programs at Loyola University Medical Center. Of the 26 programs, 9 were surgical.

The 15-item survey contained questions about perceived benefits of and support for the policy as well as its effect on lifestyle, education, and patient care.

Survey response rates for attending and resident physicians were 57% and 35%, respectively.

Dr. Esposito reported that among the respondents, 60% of residents and 47% of attendings from surgical fields personally support the policy, compared with 79% of residents and 59% of attendings from nonsurgical fields.

In addition, 53% of residents and 69% of attendings from surgical fields agree that continuity of care has declined because of the policy, compared with 41% of residents and 66% of attendings from nonsurgical fields. (See box.)

The researchers also observed that 64% of residents and 68% of attendings from surgical fields perceive patient errors to be the same or greater under the policy, compared with 65% of residents and 55% of attendings from nonsurgical fields.

As for the policy's impact on lifestyle, 53% of residents and 100% of attendings from surgical fields believe that their time spent in the hospital has remained the same or increased, compared with 59% of residents and 98% of attendings from nonsurgical fields.

Meanwhile, only 32% of residents and 38% of attendings from surgical fields agree that the residents are less stressed, compared with 53% of residents and 42% of attendings from nonsurgical fields.

The most common off-hour activities that were reported by surgical and nonsurgical resident physicians alike were sleeping (25%) and educational reading (25%).

Regarding the policy's impact on education, 35% of residents and 72% of attendings from surgical fields agree that resident education has declined, compared with 27% of residents and 61% of attendings from nonsurgical fields.

In general, residents and attendings in surgical fields show less support for and see fewer positive attributes of the policy, compared with their counterparts in nonsurgical fields, Dr. Esposito concluded.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Most resident and attending physicians expressed ambivalence regarding the 80-hour workweek policy in a survey conducted by Dr. Thomas Esposito and his associates at Loyola University Medical Center in Maywood, Ill.

“The perceptions of both residents and attendings seem to suggest that the policy change may not yet be achieving its intended objectives,” Dr. Esposito reported at a congress sponsored by the Association for Academic Surgery and the Society of University Surgeons.

“It may actually be detrimental to attendings,” he added.

Studies comparing the views of resident and attending physicians regarding the 80-hour workweek policy for medical residents, implemented in July 2003 by the Accreditation Council for Graduate Medical Education, “are sparse, and studies comparing surgical and nonsurgical practitioners also have not routinely been done,” noted Dr. Esposito, professor of surgery at the university and head of the injury analysis and prevention program at the Loyola Burn and Shock Trauma Institute.

In an effort to determine how residents and attendings from surgical and nonsurgical fields felt about the policy, Dr. Esposito and his associates distributed an electronic survey in August and September 2004 to 375 faculty and 527 residents representing 26 graduate medical education programs at Loyola University Medical Center. Of the 26 programs, 9 were surgical.

The 15-item survey contained questions about perceived benefits of and support for the policy as well as its effect on lifestyle, education, and patient care.

Survey response rates for attending and resident physicians were 57% and 35%, respectively.

Dr. Esposito reported that among the respondents, 60% of residents and 47% of attendings from surgical fields personally support the policy, compared with 79% of residents and 59% of attendings from nonsurgical fields.

In addition, 53% of residents and 69% of attendings from surgical fields agree that continuity of care has declined because of the policy, compared with 41% of residents and 66% of attendings from nonsurgical fields. (See box.)

The researchers also observed that 64% of residents and 68% of attendings from surgical fields perceive patient errors to be the same or greater under the policy, compared with 65% of residents and 55% of attendings from nonsurgical fields.

As for the policy's impact on lifestyle, 53% of residents and 100% of attendings from surgical fields believe that their time spent in the hospital has remained the same or increased, compared with 59% of residents and 98% of attendings from nonsurgical fields.

Meanwhile, only 32% of residents and 38% of attendings from surgical fields agree that the residents are less stressed, compared with 53% of residents and 42% of attendings from nonsurgical fields.

The most common off-hour activities that were reported by surgical and nonsurgical resident physicians alike were sleeping (25%) and educational reading (25%).

Regarding the policy's impact on education, 35% of residents and 72% of attendings from surgical fields agree that resident education has declined, compared with 27% of residents and 61% of attendings from nonsurgical fields.

In general, residents and attendings in surgical fields show less support for and see fewer positive attributes of the policy, compared with their counterparts in nonsurgical fields, Dr. Esposito concluded.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Most resident and attending physicians expressed ambivalence regarding the 80-hour workweek policy in a survey conducted by Dr. Thomas Esposito and his associates at Loyola University Medical Center in Maywood, Ill.

“The perceptions of both residents and attendings seem to suggest that the policy change may not yet be achieving its intended objectives,” Dr. Esposito reported at a congress sponsored by the Association for Academic Surgery and the Society of University Surgeons.

“It may actually be detrimental to attendings,” he added.

Studies comparing the views of resident and attending physicians regarding the 80-hour workweek policy for medical residents, implemented in July 2003 by the Accreditation Council for Graduate Medical Education, “are sparse, and studies comparing surgical and nonsurgical practitioners also have not routinely been done,” noted Dr. Esposito, professor of surgery at the university and head of the injury analysis and prevention program at the Loyola Burn and Shock Trauma Institute.

In an effort to determine how residents and attendings from surgical and nonsurgical fields felt about the policy, Dr. Esposito and his associates distributed an electronic survey in August and September 2004 to 375 faculty and 527 residents representing 26 graduate medical education programs at Loyola University Medical Center. Of the 26 programs, 9 were surgical.

The 15-item survey contained questions about perceived benefits of and support for the policy as well as its effect on lifestyle, education, and patient care.

Survey response rates for attending and resident physicians were 57% and 35%, respectively.

Dr. Esposito reported that among the respondents, 60% of residents and 47% of attendings from surgical fields personally support the policy, compared with 79% of residents and 59% of attendings from nonsurgical fields.

In addition, 53% of residents and 69% of attendings from surgical fields agree that continuity of care has declined because of the policy, compared with 41% of residents and 66% of attendings from nonsurgical fields. (See box.)

The researchers also observed that 64% of residents and 68% of attendings from surgical fields perceive patient errors to be the same or greater under the policy, compared with 65% of residents and 55% of attendings from nonsurgical fields.

As for the policy's impact on lifestyle, 53% of residents and 100% of attendings from surgical fields believe that their time spent in the hospital has remained the same or increased, compared with 59% of residents and 98% of attendings from nonsurgical fields.

Meanwhile, only 32% of residents and 38% of attendings from surgical fields agree that the residents are less stressed, compared with 53% of residents and 42% of attendings from nonsurgical fields.

The most common off-hour activities that were reported by surgical and nonsurgical resident physicians alike were sleeping (25%) and educational reading (25%).

Regarding the policy's impact on education, 35% of residents and 72% of attendings from surgical fields agree that resident education has declined, compared with 27% of residents and 61% of attendings from nonsurgical fields.

In general, residents and attendings in surgical fields show less support for and see fewer positive attributes of the policy, compared with their counterparts in nonsurgical fields, Dr. Esposito concluded.

ELSEVIER GLOBAL MEDICAL NEWS

PALM SPRINGS, CALIF. — Routine medical care and comprehensive health insurance coverage seem to improve the early detection of epithelial ovarian cancer in women aged 59 and younger, but not in those aged 60 and older, Dr. Sherry H. Weitzen reported in a poster session at the annual meeting of the Society of Gynecologic Oncologists.

“It surprised me that there was very little effect of access to care for older women in terms of being diagnosed at an earlier stage,” Dr. Weitzen, an epidemiologist in the obstetrics and gynecology department at Brown University, Providence, R.I., said in an interview.

“I was disappointed because … it seems like older women are doomed to being diagnosed later. That's what the literature says anyway, and there seems to be no kind of help for them [even] if they are vigilant about their health care.”

Dr. Weitzen and her associates reviewed the medical charts of 832 women diagnosed with epithelial ovarian cancer at Women and Infants Hospital in Providence between 1991 and 2004.

They used International Federation of Gynecology and Obstetrics (FIGO) standards to determine tumor stage during or after surgery, and defined health insurance as private/Medicare and Medicaid/uninsured/self-pay/none documented.

Of the 832 women, most (540) were diagnosed with late-stage disease, 82% were insured by Medicare or private insurance plans, and 66% reported having a “usual” care provider.

Of the 292 women diagnosed with early-stage disease, 71% reported having routine medical care, compared with 63% of their counterparts who were diagnosed with late-stage disease. In addition, 85% of women with early-stage disease had Medicare or private insurance, compared with 80% of women diagnosed with late-stage disease.

After adjusting for age at diagnosis, the researchers found that women who had routine medical care plus Medicare and/or private insurance were 1.74 times more likely to have ovarian cancer diagnosed at an early stage, compared with those who had no routine care and no other insurance plans.

“For women less than 60 years of age, the combined effect of having both routine care and better health insurance had two times the odds of earlier diagnosis, compared to women with no routine care and other health insurance,” the researchers wrote in their poster.

Dr. Weitzen said the study underscores the importance of early detection, noting that physicians “should encourage their patients to come in regularly.”

PALM SPRINGS, CALIF. — Routine medical care and comprehensive health insurance coverage seem to improve the early detection of epithelial ovarian cancer in women aged 59 and younger, but not in those aged 60 and older, Dr. Sherry H. Weitzen reported in a poster session at the annual meeting of the Society of Gynecologic Oncologists.

“It surprised me that there was very little effect of access to care for older women in terms of being diagnosed at an earlier stage,” Dr. Weitzen, an epidemiologist in the obstetrics and gynecology department at Brown University, Providence, R.I., said in an interview.

“I was disappointed because … it seems like older women are doomed to being diagnosed later. That's what the literature says anyway, and there seems to be no kind of help for them [even] if they are vigilant about their health care.”

Dr. Weitzen and her associates reviewed the medical charts of 832 women diagnosed with epithelial ovarian cancer at Women and Infants Hospital in Providence between 1991 and 2004.

They used International Federation of Gynecology and Obstetrics (FIGO) standards to determine tumor stage during or after surgery, and defined health insurance as private/Medicare and Medicaid/uninsured/self-pay/none documented.

Of the 832 women, most (540) were diagnosed with late-stage disease, 82% were insured by Medicare or private insurance plans, and 66% reported having a “usual” care provider.

Of the 292 women diagnosed with early-stage disease, 71% reported having routine medical care, compared with 63% of their counterparts who were diagnosed with late-stage disease. In addition, 85% of women with early-stage disease had Medicare or private insurance, compared with 80% of women diagnosed with late-stage disease.

After adjusting for age at diagnosis, the researchers found that women who had routine medical care plus Medicare and/or private insurance were 1.74 times more likely to have ovarian cancer diagnosed at an early stage, compared with those who had no routine care and no other insurance plans.

“For women less than 60 years of age, the combined effect of having both routine care and better health insurance had two times the odds of earlier diagnosis, compared to women with no routine care and other health insurance,” the researchers wrote in their poster.

Dr. Weitzen said the study underscores the importance of early detection, noting that physicians “should encourage their patients to come in regularly.”

PALM SPRINGS, CALIF. — Routine medical care and comprehensive health insurance coverage seem to improve the early detection of epithelial ovarian cancer in women aged 59 and younger, but not in those aged 60 and older, Dr. Sherry H. Weitzen reported in a poster session at the annual meeting of the Society of Gynecologic Oncologists.

“It surprised me that there was very little effect of access to care for older women in terms of being diagnosed at an earlier stage,” Dr. Weitzen, an epidemiologist in the obstetrics and gynecology department at Brown University, Providence, R.I., said in an interview.

“I was disappointed because … it seems like older women are doomed to being diagnosed later. That's what the literature says anyway, and there seems to be no kind of help for them [even] if they are vigilant about their health care.”

Dr. Weitzen and her associates reviewed the medical charts of 832 women diagnosed with epithelial ovarian cancer at Women and Infants Hospital in Providence between 1991 and 2004.

They used International Federation of Gynecology and Obstetrics (FIGO) standards to determine tumor stage during or after surgery, and defined health insurance as private/Medicare and Medicaid/uninsured/self-pay/none documented.

Of the 832 women, most (540) were diagnosed with late-stage disease, 82% were insured by Medicare or private insurance plans, and 66% reported having a “usual” care provider.

Of the 292 women diagnosed with early-stage disease, 71% reported having routine medical care, compared with 63% of their counterparts who were diagnosed with late-stage disease. In addition, 85% of women with early-stage disease had Medicare or private insurance, compared with 80% of women diagnosed with late-stage disease.

After adjusting for age at diagnosis, the researchers found that women who had routine medical care plus Medicare and/or private insurance were 1.74 times more likely to have ovarian cancer diagnosed at an early stage, compared with those who had no routine care and no other insurance plans.

“For women less than 60 years of age, the combined effect of having both routine care and better health insurance had two times the odds of earlier diagnosis, compared to women with no routine care and other health insurance,” the researchers wrote in their poster.

Dr. Weitzen said the study underscores the importance of early detection, noting that physicians “should encourage their patients to come in regularly.”

PALM SPRINGS, CALIF. — Women with cervical cancer who received weekly cisplatin treatment had significantly worse progression-free survival rates and significantly worse toxicity than did those who received cisplatin 5 days in a row every 21 days, according to results of a long-term, single-site, retrospective study.

The finding is important, because about 5 years ago the weekly regimen became the standard of care, due primarily to the ease of weekly dosing and the lower cost of outpatient administration, Dr. Mark Einstein said in an interview at the annual meeting of the Society of Gynecologic Oncologists.

“In the past we used to do an inpatient infusional dosing of cisplatin concomitant with radiation therapy for the treatment of locally advanced cervical cancer,” he explained. “In 2001 there was a switch over to outpatient weekly regimens, but there was never really a trial to show that the [outcomes] are the same between the two patient regimens.”

He and his associates studied 77 consecutive patients with stages IB2-IV cervical cancer who were treated with cisplatin concomitant with external mean radiotherapy and two 9-Gy high-dose-rate brachytherapy insertions at the Montefiore Medical Center of the Albert Einstein College of Medicine, Bronx, N.Y., between 1995 and 2004. The 50 women in the 5-day treatment group received cisplatin 20 mg/m

Nearly half of the women in the 5-day treatment group (48%) had stage III or IV disease, compared with 26% of women in the weekly treatment group. The rest of the women had stage IB2 or II disease. The median follow-up was 42 months.

Dr. Einstein, a gynecologic oncologist with the Albert Einstein College of Medicine, reported that there were no significant differences between the two treatment groups in terms of age, race, histology, body mass index, anemia, and total radiotherapy doses.

Overall, 3-year progression-free survival was 81% for the 5-day treatment group, compared with 66% for the weekly treatment group, a difference that was statistically significant.

After the researchers adjusted for cancer stage, patient age, and completion of treatment, women in the weekly treatment group were 3.5 times more likely to fail treatment than were their counterparts in the 5-day treatment group. Similarly, women in the weekly treatment group were 2.7 times more likely to die from cervical cancer than were those in the 5-day treatment group.

Dr. Einstein also reported that women with late-stage disease who received weekly treatment were 3.43 times more likely to develop acute toxicity—primarily in the GI tract—compared with their counterparts in the 5-day treatment group. “That's probably [because the 5-day group] got a lot more fluids when the patients were in the hospital, while they were getting their chemotherapy,” he speculated. “But that difference is hard to glean out.”

Dr. Einstein emphasized that a multicenter, randomized, controlled trial is needed to confirm the findings. He and his associates are working on such a trial design and may add a third treatment arm of women who receive sustained low-dose cisplatin throughout their radiation therapy. “The idea [is] that with the 5-day infusion, they're getting a relatively sustained dose once every 3 weeks,” he said. “Maybe it's that sustained dose that's improving the survival benefit.”

PALM SPRINGS, CALIF. — Women with cervical cancer who received weekly cisplatin treatment had significantly worse progression-free survival rates and significantly worse toxicity than did those who received cisplatin 5 days in a row every 21 days, according to results of a long-term, single-site, retrospective study.

The finding is important, because about 5 years ago the weekly regimen became the standard of care, due primarily to the ease of weekly dosing and the lower cost of outpatient administration, Dr. Mark Einstein said in an interview at the annual meeting of the Society of Gynecologic Oncologists.

“In the past we used to do an inpatient infusional dosing of cisplatin concomitant with radiation therapy for the treatment of locally advanced cervical cancer,” he explained. “In 2001 there was a switch over to outpatient weekly regimens, but there was never really a trial to show that the [outcomes] are the same between the two patient regimens.”

He and his associates studied 77 consecutive patients with stages IB2-IV cervical cancer who were treated with cisplatin concomitant with external mean radiotherapy and two 9-Gy high-dose-rate brachytherapy insertions at the Montefiore Medical Center of the Albert Einstein College of Medicine, Bronx, N.Y., between 1995 and 2004. The 50 women in the 5-day treatment group received cisplatin 20 mg/m

Nearly half of the women in the 5-day treatment group (48%) had stage III or IV disease, compared with 26% of women in the weekly treatment group. The rest of the women had stage IB2 or II disease. The median follow-up was 42 months.

Dr. Einstein, a gynecologic oncologist with the Albert Einstein College of Medicine, reported that there were no significant differences between the two treatment groups in terms of age, race, histology, body mass index, anemia, and total radiotherapy doses.

Overall, 3-year progression-free survival was 81% for the 5-day treatment group, compared with 66% for the weekly treatment group, a difference that was statistically significant.

After the researchers adjusted for cancer stage, patient age, and completion of treatment, women in the weekly treatment group were 3.5 times more likely to fail treatment than were their counterparts in the 5-day treatment group. Similarly, women in the weekly treatment group were 2.7 times more likely to die from cervical cancer than were those in the 5-day treatment group.

Dr. Einstein also reported that women with late-stage disease who received weekly treatment were 3.43 times more likely to develop acute toxicity—primarily in the GI tract—compared with their counterparts in the 5-day treatment group. “That's probably [because the 5-day group] got a lot more fluids when the patients were in the hospital, while they were getting their chemotherapy,” he speculated. “But that difference is hard to glean out.”

Dr. Einstein emphasized that a multicenter, randomized, controlled trial is needed to confirm the findings. He and his associates are working on such a trial design and may add a third treatment arm of women who receive sustained low-dose cisplatin throughout their radiation therapy. “The idea [is] that with the 5-day infusion, they're getting a relatively sustained dose once every 3 weeks,” he said. “Maybe it's that sustained dose that's improving the survival benefit.”

PALM SPRINGS, CALIF. — Women with cervical cancer who received weekly cisplatin treatment had significantly worse progression-free survival rates and significantly worse toxicity than did those who received cisplatin 5 days in a row every 21 days, according to results of a long-term, single-site, retrospective study.

The finding is important, because about 5 years ago the weekly regimen became the standard of care, due primarily to the ease of weekly dosing and the lower cost of outpatient administration, Dr. Mark Einstein said in an interview at the annual meeting of the Society of Gynecologic Oncologists.

“In the past we used to do an inpatient infusional dosing of cisplatin concomitant with radiation therapy for the treatment of locally advanced cervical cancer,” he explained. “In 2001 there was a switch over to outpatient weekly regimens, but there was never really a trial to show that the [outcomes] are the same between the two patient regimens.”

He and his associates studied 77 consecutive patients with stages IB2-IV cervical cancer who were treated with cisplatin concomitant with external mean radiotherapy and two 9-Gy high-dose-rate brachytherapy insertions at the Montefiore Medical Center of the Albert Einstein College of Medicine, Bronx, N.Y., between 1995 and 2004. The 50 women in the 5-day treatment group received cisplatin 20 mg/m

Nearly half of the women in the 5-day treatment group (48%) had stage III or IV disease, compared with 26% of women in the weekly treatment group. The rest of the women had stage IB2 or II disease. The median follow-up was 42 months.

Dr. Einstein, a gynecologic oncologist with the Albert Einstein College of Medicine, reported that there were no significant differences between the two treatment groups in terms of age, race, histology, body mass index, anemia, and total radiotherapy doses.

Overall, 3-year progression-free survival was 81% for the 5-day treatment group, compared with 66% for the weekly treatment group, a difference that was statistically significant.

After the researchers adjusted for cancer stage, patient age, and completion of treatment, women in the weekly treatment group were 3.5 times more likely to fail treatment than were their counterparts in the 5-day treatment group. Similarly, women in the weekly treatment group were 2.7 times more likely to die from cervical cancer than were those in the 5-day treatment group.

Dr. Einstein also reported that women with late-stage disease who received weekly treatment were 3.43 times more likely to develop acute toxicity—primarily in the GI tract—compared with their counterparts in the 5-day treatment group. “That's probably [because the 5-day group] got a lot more fluids when the patients were in the hospital, while they were getting their chemotherapy,” he speculated. “But that difference is hard to glean out.”

Dr. Einstein emphasized that a multicenter, randomized, controlled trial is needed to confirm the findings. He and his associates are working on such a trial design and may add a third treatment arm of women who receive sustained low-dose cisplatin throughout their radiation therapy. “The idea [is] that with the 5-day infusion, they're getting a relatively sustained dose once every 3 weeks,” he said. “Maybe it's that sustained dose that's improving the survival benefit.”

PALM SPRINGS, CALIF. — Only about 14% of women with ovarian cancer were offered enrollment into a clinical trial after their diagnosis, results from a survey of Oregon patients demonstrated.

“Most women with ovarian cancer are not offered enrollment into a clinical trial,” Dr. Fabio Cappuccini said at the annual meeting of the Society of Gynecologic Oncologists. “If they don't know about a clinical trial … this limits the number of patients we can study. Are we doing the right thing? Are we making every effort to educate patients and health providers about this problem?”

Dr. Cappuccini, a gynecologic oncologist at Oregon Health and Science University, Portland, and his associates mailed surveys to 560 women in the state who were diagnosed with ovarian cancer between 1999 and 2003.

“We used the state of Oregon as a model for several reasons,” he explained. “The state is small. With 4 million people, it's easy to survey. There are large metropolitan areas, and there is … representation of ethnic groups. Specialists and subspecialists are readily available.”

The 262 women who returned completed surveys had a mean age of 61, and most (96%) were white. Nearly all respondents (99%) underwent surgery for cancer, and 87% received chemotherapy.

Fewer than 25% of the women reported having some knowledge about clinical trials at the time of diagnosis. In addition, of the 262 survey respondents, only 36 (14%) were offered entry into a clinical trial. Of these, more than half accepted the enrollment.

“Their main reasons for accepting were a desire to help future patients and ovarian cancer research, a doctor's recommendation, and receiving a thorough explanation of the trial,” the researchers wrote in their abstract. “The women who declined did so mainly because they did not know which treatment they would receive, the trial was inconvenient, and they felt that the trial was a gamble.”

Dr. Edward L. Trimble, who was invited by the meeting organizers to comment on the study, cited several factors that affect the accrual of patients with ovarian cancer into clinical trials. “Does the patient trust the doctor? That is probably the most important,” said Dr. Trimble, who heads the surgery section of the National Cancer Institute's Cancer Therapy Evaluation Program. “Second, are the doctors and nurse excited about the trial that's being conducted?”

Eligibility is a third factor. “Too often older patients or minority patients have comorbidities that preclude their participation in clinical trials,” he noted. “We need to go back and look at our eligibility requirements to see where we can simplify them so more patients are eligible for our trials.”

He called access to clinical trials for women with ovarian cancer “a major issue, in part because of the red tape and the cost of our trials. Institutions need to make a commitment to clinical trials, having institutional review boards that function effectively, and having a clinical trials office. We know that there are major costs associated with … the time for the doctors and nurses, time for the data managers, and the work that the pathologists and radiologists may put in. There's a whole host of costs. In most cases that cost is not covered entirely by the NCI funds.”

PALM SPRINGS, CALIF. — Only about 14% of women with ovarian cancer were offered enrollment into a clinical trial after their diagnosis, results from a survey of Oregon patients demonstrated.

“Most women with ovarian cancer are not offered enrollment into a clinical trial,” Dr. Fabio Cappuccini said at the annual meeting of the Society of Gynecologic Oncologists. “If they don't know about a clinical trial … this limits the number of patients we can study. Are we doing the right thing? Are we making every effort to educate patients and health providers about this problem?”

Dr. Cappuccini, a gynecologic oncologist at Oregon Health and Science University, Portland, and his associates mailed surveys to 560 women in the state who were diagnosed with ovarian cancer between 1999 and 2003.

“We used the state of Oregon as a model for several reasons,” he explained. “The state is small. With 4 million people, it's easy to survey. There are large metropolitan areas, and there is … representation of ethnic groups. Specialists and subspecialists are readily available.”

The 262 women who returned completed surveys had a mean age of 61, and most (96%) were white. Nearly all respondents (99%) underwent surgery for cancer, and 87% received chemotherapy.

Fewer than 25% of the women reported having some knowledge about clinical trials at the time of diagnosis. In addition, of the 262 survey respondents, only 36 (14%) were offered entry into a clinical trial. Of these, more than half accepted the enrollment.

“Their main reasons for accepting were a desire to help future patients and ovarian cancer research, a doctor's recommendation, and receiving a thorough explanation of the trial,” the researchers wrote in their abstract. “The women who declined did so mainly because they did not know which treatment they would receive, the trial was inconvenient, and they felt that the trial was a gamble.”

Dr. Edward L. Trimble, who was invited by the meeting organizers to comment on the study, cited several factors that affect the accrual of patients with ovarian cancer into clinical trials. “Does the patient trust the doctor? That is probably the most important,” said Dr. Trimble, who heads the surgery section of the National Cancer Institute's Cancer Therapy Evaluation Program. “Second, are the doctors and nurse excited about the trial that's being conducted?”

Eligibility is a third factor. “Too often older patients or minority patients have comorbidities that preclude their participation in clinical trials,” he noted. “We need to go back and look at our eligibility requirements to see where we can simplify them so more patients are eligible for our trials.”

He called access to clinical trials for women with ovarian cancer “a major issue, in part because of the red tape and the cost of our trials. Institutions need to make a commitment to clinical trials, having institutional review boards that function effectively, and having a clinical trials office. We know that there are major costs associated with … the time for the doctors and nurses, time for the data managers, and the work that the pathologists and radiologists may put in. There's a whole host of costs. In most cases that cost is not covered entirely by the NCI funds.”

PALM SPRINGS, CALIF. — Only about 14% of women with ovarian cancer were offered enrollment into a clinical trial after their diagnosis, results from a survey of Oregon patients demonstrated.

“Most women with ovarian cancer are not offered enrollment into a clinical trial,” Dr. Fabio Cappuccini said at the annual meeting of the Society of Gynecologic Oncologists. “If they don't know about a clinical trial … this limits the number of patients we can study. Are we doing the right thing? Are we making every effort to educate patients and health providers about this problem?”

Dr. Cappuccini, a gynecologic oncologist at Oregon Health and Science University, Portland, and his associates mailed surveys to 560 women in the state who were diagnosed with ovarian cancer between 1999 and 2003.

“We used the state of Oregon as a model for several reasons,” he explained. “The state is small. With 4 million people, it's easy to survey. There are large metropolitan areas, and there is … representation of ethnic groups. Specialists and subspecialists are readily available.”

The 262 women who returned completed surveys had a mean age of 61, and most (96%) were white. Nearly all respondents (99%) underwent surgery for cancer, and 87% received chemotherapy.

Fewer than 25% of the women reported having some knowledge about clinical trials at the time of diagnosis. In addition, of the 262 survey respondents, only 36 (14%) were offered entry into a clinical trial. Of these, more than half accepted the enrollment.

“Their main reasons for accepting were a desire to help future patients and ovarian cancer research, a doctor's recommendation, and receiving a thorough explanation of the trial,” the researchers wrote in their abstract. “The women who declined did so mainly because they did not know which treatment they would receive, the trial was inconvenient, and they felt that the trial was a gamble.”

Dr. Edward L. Trimble, who was invited by the meeting organizers to comment on the study, cited several factors that affect the accrual of patients with ovarian cancer into clinical trials. “Does the patient trust the doctor? That is probably the most important,” said Dr. Trimble, who heads the surgery section of the National Cancer Institute's Cancer Therapy Evaluation Program. “Second, are the doctors and nurse excited about the trial that's being conducted?”

Eligibility is a third factor. “Too often older patients or minority patients have comorbidities that preclude their participation in clinical trials,” he noted. “We need to go back and look at our eligibility requirements to see where we can simplify them so more patients are eligible for our trials.”

He called access to clinical trials for women with ovarian cancer “a major issue, in part because of the red tape and the cost of our trials. Institutions need to make a commitment to clinical trials, having institutional review boards that function effectively, and having a clinical trials office. We know that there are major costs associated with … the time for the doctors and nurses, time for the data managers, and the work that the pathologists and radiologists may put in. There's a whole host of costs. In most cases that cost is not covered entirely by the NCI funds.”

Patients with multinodular goiter required a thyroxine dosage increase of 22%–34% if they had impaired secretion of stomach acids, results from a large controlled study demonstrated.

The finding suggests that “normal gastric acid secretion is important for the subsequent intestinal absorption of thyroxine,” wrote the researchers, led by Dr. Marco Centanni of the department of experimental medicine and pathology at La Sapienza University, Rome.

“Although the clinical importance of these findings is fairly clear, the mechanism by which intestinal absorption of thyroxine is impaired in patients with hypochlorhydria is unknown. We may only speculate that oral thyroxine is administered as sodium salt that is less lipophilic than the native hormone, which enters target cells both through passive diffusion and in a carrier-mediated, inhibitable way. In this respect, achlorhydria due to atrophic gastritis, the production of ammonia, or both, which are characteristic of [Helicobacter] pylori infection, may alter the ionization status and the conformational characteristics of the thyroxine molecule and thus the efficiency of intestinal absorption of the hormone.”

The group studied 248 patients with nontoxic multinodular goiter who were seen at a referral center for thyroid disease between 1999 and 2004. Of the 248 patients, 53 also had H. pylori-related gastritis and 60 had atrophic gastritis of the body of the stomach (31 with evidence of H. pylori infection and 29 without such evidence).The remaining 135 patients had no gastric disorders and served as the reference group (N. Engl. J. Med. 2006;354:1787–95).

All patients received an initial thyroxine dose of 50 μg per day and were followed for at least 30 months. The researchers evaluated the thyroid-pituitary axis every 4 months and, if needed, increased the thyroxine dose until a low serum thyrotropin level was achieved on at least two consecutive measurements. The thyrotropin level was considered low if it was between 0.05 and 0.20 mU per liter.

The researchers also studied the levels of serum thyrotropin in 11 women diagnosed with H. pylori infection 4–19 months after the study began, and in 10 women diagnosed with gastroesophageal reflux disease after the study began. These 10 women were given omeprazole along with thyroxine. Serum thyrotropin levels continued to be measured after treatment with omeprazole began.

Compared with patients in the reference group, all patients who had impaired secretion of gastric acid required statistically significant increases in their daily doses of thyroxine to achieve low levels of serum thyrotropin. The median thyroxine dose required of the 53 patients with H. pylori-related gastritis was 125 μg per day, which was a 22% median increase from that of the referent group.

The median thyroxine dose required of the 60 patients with atrophic gastritis of the body of the stomach also was 125 mg per day, which was a 27% median increase from that of the referent group. (Those with evidence of H. pylori infection required a median thyroxine dose of 150 μg per day, a median increase of 34% from that of the referent group, while those without such evidence required a median thyroxine dose of 125 μg per day, a median increase of 24% from that of the referent group.) Serum thyrotropin levels rose variably in the cohort of 11 women with newly diagnosed H. pylori infection.

“In some patients, a slightly higher dose of thyroxine was needed to restore thyrotropin suppression,” the researchers wrote. “Likewise, the increase in the level of serum thyrotropin was variable in patients treated with omeprazole, although the suppressive effect of thyroxine on thyrotropin disappeared in all patients and was restored only at a substantially higher dose of thyroxine.”

Patients with multinodular goiter required a thyroxine dosage increase of 22%–34% if they had impaired secretion of stomach acids, results from a large controlled study demonstrated.

The finding suggests that “normal gastric acid secretion is important for the subsequent intestinal absorption of thyroxine,” wrote the researchers, led by Dr. Marco Centanni of the department of experimental medicine and pathology at La Sapienza University, Rome.

“Although the clinical importance of these findings is fairly clear, the mechanism by which intestinal absorption of thyroxine is impaired in patients with hypochlorhydria is unknown. We may only speculate that oral thyroxine is administered as sodium salt that is less lipophilic than the native hormone, which enters target cells both through passive diffusion and in a carrier-mediated, inhibitable way. In this respect, achlorhydria due to atrophic gastritis, the production of ammonia, or both, which are characteristic of [Helicobacter] pylori infection, may alter the ionization status and the conformational characteristics of the thyroxine molecule and thus the efficiency of intestinal absorption of the hormone.”

The group studied 248 patients with nontoxic multinodular goiter who were seen at a referral center for thyroid disease between 1999 and 2004. Of the 248 patients, 53 also had H. pylori-related gastritis and 60 had atrophic gastritis of the body of the stomach (31 with evidence of H. pylori infection and 29 without such evidence).The remaining 135 patients had no gastric disorders and served as the reference group (N. Engl. J. Med. 2006;354:1787–95).

All patients received an initial thyroxine dose of 50 μg per day and were followed for at least 30 months. The researchers evaluated the thyroid-pituitary axis every 4 months and, if needed, increased the thyroxine dose until a low serum thyrotropin level was achieved on at least two consecutive measurements. The thyrotropin level was considered low if it was between 0.05 and 0.20 mU per liter.

The researchers also studied the levels of serum thyrotropin in 11 women diagnosed with H. pylori infection 4–19 months after the study began, and in 10 women diagnosed with gastroesophageal reflux disease after the study began. These 10 women were given omeprazole along with thyroxine. Serum thyrotropin levels continued to be measured after treatment with omeprazole began.

Compared with patients in the reference group, all patients who had impaired secretion of gastric acid required statistically significant increases in their daily doses of thyroxine to achieve low levels of serum thyrotropin. The median thyroxine dose required of the 53 patients with H. pylori-related gastritis was 125 μg per day, which was a 22% median increase from that of the referent group.

The median thyroxine dose required of the 60 patients with atrophic gastritis of the body of the stomach also was 125 mg per day, which was a 27% median increase from that of the referent group. (Those with evidence of H. pylori infection required a median thyroxine dose of 150 μg per day, a median increase of 34% from that of the referent group, while those without such evidence required a median thyroxine dose of 125 μg per day, a median increase of 24% from that of the referent group.) Serum thyrotropin levels rose variably in the cohort of 11 women with newly diagnosed H. pylori infection.

“In some patients, a slightly higher dose of thyroxine was needed to restore thyrotropin suppression,” the researchers wrote. “Likewise, the increase in the level of serum thyrotropin was variable in patients treated with omeprazole, although the suppressive effect of thyroxine on thyrotropin disappeared in all patients and was restored only at a substantially higher dose of thyroxine.”

Patients with multinodular goiter required a thyroxine dosage increase of 22%–34% if they had impaired secretion of stomach acids, results from a large controlled study demonstrated.

The finding suggests that “normal gastric acid secretion is important for the subsequent intestinal absorption of thyroxine,” wrote the researchers, led by Dr. Marco Centanni of the department of experimental medicine and pathology at La Sapienza University, Rome.

“Although the clinical importance of these findings is fairly clear, the mechanism by which intestinal absorption of thyroxine is impaired in patients with hypochlorhydria is unknown. We may only speculate that oral thyroxine is administered as sodium salt that is less lipophilic than the native hormone, which enters target cells both through passive diffusion and in a carrier-mediated, inhibitable way. In this respect, achlorhydria due to atrophic gastritis, the production of ammonia, or both, which are characteristic of [Helicobacter] pylori infection, may alter the ionization status and the conformational characteristics of the thyroxine molecule and thus the efficiency of intestinal absorption of the hormone.”

The group studied 248 patients with nontoxic multinodular goiter who were seen at a referral center for thyroid disease between 1999 and 2004. Of the 248 patients, 53 also had H. pylori-related gastritis and 60 had atrophic gastritis of the body of the stomach (31 with evidence of H. pylori infection and 29 without such evidence).The remaining 135 patients had no gastric disorders and served as the reference group (N. Engl. J. Med. 2006;354:1787–95).

All patients received an initial thyroxine dose of 50 μg per day and were followed for at least 30 months. The researchers evaluated the thyroid-pituitary axis every 4 months and, if needed, increased the thyroxine dose until a low serum thyrotropin level was achieved on at least two consecutive measurements. The thyrotropin level was considered low if it was between 0.05 and 0.20 mU per liter.

The researchers also studied the levels of serum thyrotropin in 11 women diagnosed with H. pylori infection 4–19 months after the study began, and in 10 women diagnosed with gastroesophageal reflux disease after the study began. These 10 women were given omeprazole along with thyroxine. Serum thyrotropin levels continued to be measured after treatment with omeprazole began.

Compared with patients in the reference group, all patients who had impaired secretion of gastric acid required statistically significant increases in their daily doses of thyroxine to achieve low levels of serum thyrotropin. The median thyroxine dose required of the 53 patients with H. pylori-related gastritis was 125 μg per day, which was a 22% median increase from that of the referent group.

The median thyroxine dose required of the 60 patients with atrophic gastritis of the body of the stomach also was 125 mg per day, which was a 27% median increase from that of the referent group. (Those with evidence of H. pylori infection required a median thyroxine dose of 150 μg per day, a median increase of 34% from that of the referent group, while those without such evidence required a median thyroxine dose of 125 μg per day, a median increase of 24% from that of the referent group.) Serum thyrotropin levels rose variably in the cohort of 11 women with newly diagnosed H. pylori infection.

“In some patients, a slightly higher dose of thyroxine was needed to restore thyrotropin suppression,” the researchers wrote. “Likewise, the increase in the level of serum thyrotropin was variable in patients treated with omeprazole, although the suppressive effect of thyroxine on thyrotropin disappeared in all patients and was restored only at a substantially higher dose of thyroxine.”

PALM SPRINGS, CALIF. — The best predictor for ovarian malignancy in a postmenopausal woman with an initial abnormal screen is a CA 125 level of 65 U/mL or greater, Dr. Edward E. Partridge said at the annual meeting of the Society of Gynecologic Oncologists.

He also reported that in women who have a follow-up screen, these four criteria, in hierarchical order, appear to be accurate in detecting malignancy: a CA 125 level of 65 U/mL or greater; a CA 125 increase of 40 points or more; a CA 125 change of 10 points with an ovary and/or cyst 3 cm or greater in size; or an ovary/cyst change of 6.5 cm or more.

The findings are based on an analysis of data from the first 3 years of the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

“This should provide some guidance for clinical decisions regarding the need for surgery and/or appropriate referral for asymptomatic postmenopausal women with abnormal findings on CA-125 and/or transvaginal ultrasound,” said Dr. Partridge, associate director of cancer prevention and control at the University of Alabama, Birmingham, and director of the UAB Comprehensive Cancer Center.

However, he was quick to note that he does not recommend the routine clinical use of CA 125 and transvaginal ultrasound to detect ovarian cancer in asymptomatic postmenopausal women at this time. “We are not encouraging these tests until the trial is complete,” he said. “If one does have these tests it gives some reassurance that you do not have to undergo an operative procedure if these criteria are not met.”

Although the study is the largest of its kind to date, the criteria used in the analysis “are empirically based and represent one approach to combine the criteria,” Dr. Partridge added. “The model has not been validated in a separate, similar population. Therefore it may be overly optimistic in its predictability.”

The purpose of the study was to quantify and characterize the occurrence of ovarian malignancy among 28,506 women aged 55–74 years in the Prostate, Lung, Colon, and Ovarian Cancer Screening Trial who underwent both CA 125 and transvaginal ultrasound at their initial evaluation and during subsequent screening years 1–3.

“The major objective from a clinical standpoint was to establish clinically useful criteria to assess the likelihood of finding a malignancy after an abnormal screen,” he said.

A positive screen was defined as a CA 125 level of 65 U/mL or greater; ovarian or cyst volume of greater than 10 cm

At the baseline screen, the researchers analyzed the relationship of the following factors to ovarian cancer detection: age, race, family history, CA 125 level, maximum ovary/cyst diameter, presence of mixed/irregular/papillary features, and presence of a solid mass.

They analyzed the relationship of these factors to positive screens from subsequent years as well, plus the change in CA 125 level and the change in ovary/cyst size from the previous negative screen.

Dr. Partridge and his associates found that the best predictor for malignancy in a woman with an abnormal baseline screen is a CA 125 level of 65 U/mL or greater. Using this criterion, the researchers would have been able to detect 15 of the 20 cancers found in that cohort of women. This would have required 71 operative procedures and yielded a positive predictive value of 21%.

In women who have a follow-up screen, researchers using the four criteria of CA 125 level, CA 125 increase, CA 125 point increase with ovary/cyst 3 cm or greater in size, or an ovary/cyst change of 6.5 cm or more would have been able to detect all 29 cancers found in this cohort.

“This is very useful information,” said Dr. Nicole Urban, who was invited by the meeting organizers to comment on the work.

“My biggest concern is that even though this rule will do a good job at minimizing surgeries, what it's not doing a good job of is finding early-stage cancer,” said Dr. Urban of the Seattle-based Fred Hutchinson Cancer Center. “There are many people who were hoping that ultrasound would work better than this.”

PALM SPRINGS, CALIF. — The best predictor for ovarian malignancy in a postmenopausal woman with an initial abnormal screen is a CA 125 level of 65 U/mL or greater, Dr. Edward E. Partridge said at the annual meeting of the Society of Gynecologic Oncologists.

He also reported that in women who have a follow-up screen, these four criteria, in hierarchical order, appear to be accurate in detecting malignancy: a CA 125 level of 65 U/mL or greater; a CA 125 increase of 40 points or more; a CA 125 change of 10 points with an ovary and/or cyst 3 cm or greater in size; or an ovary/cyst change of 6.5 cm or more.

The findings are based on an analysis of data from the first 3 years of the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

“This should provide some guidance for clinical decisions regarding the need for surgery and/or appropriate referral for asymptomatic postmenopausal women with abnormal findings on CA-125 and/or transvaginal ultrasound,” said Dr. Partridge, associate director of cancer prevention and control at the University of Alabama, Birmingham, and director of the UAB Comprehensive Cancer Center.

However, he was quick to note that he does not recommend the routine clinical use of CA 125 and transvaginal ultrasound to detect ovarian cancer in asymptomatic postmenopausal women at this time. “We are not encouraging these tests until the trial is complete,” he said. “If one does have these tests it gives some reassurance that you do not have to undergo an operative procedure if these criteria are not met.”

Although the study is the largest of its kind to date, the criteria used in the analysis “are empirically based and represent one approach to combine the criteria,” Dr. Partridge added. “The model has not been validated in a separate, similar population. Therefore it may be overly optimistic in its predictability.”

The purpose of the study was to quantify and characterize the occurrence of ovarian malignancy among 28,506 women aged 55–74 years in the Prostate, Lung, Colon, and Ovarian Cancer Screening Trial who underwent both CA 125 and transvaginal ultrasound at their initial evaluation and during subsequent screening years 1–3.

“The major objective from a clinical standpoint was to establish clinically useful criteria to assess the likelihood of finding a malignancy after an abnormal screen,” he said.

A positive screen was defined as a CA 125 level of 65 U/mL or greater; ovarian or cyst volume of greater than 10 cm

At the baseline screen, the researchers analyzed the relationship of the following factors to ovarian cancer detection: age, race, family history, CA 125 level, maximum ovary/cyst diameter, presence of mixed/irregular/papillary features, and presence of a solid mass.

They analyzed the relationship of these factors to positive screens from subsequent years as well, plus the change in CA 125 level and the change in ovary/cyst size from the previous negative screen.

Dr. Partridge and his associates found that the best predictor for malignancy in a woman with an abnormal baseline screen is a CA 125 level of 65 U/mL or greater. Using this criterion, the researchers would have been able to detect 15 of the 20 cancers found in that cohort of women. This would have required 71 operative procedures and yielded a positive predictive value of 21%.

In women who have a follow-up screen, researchers using the four criteria of CA 125 level, CA 125 increase, CA 125 point increase with ovary/cyst 3 cm or greater in size, or an ovary/cyst change of 6.5 cm or more would have been able to detect all 29 cancers found in this cohort.

“This is very useful information,” said Dr. Nicole Urban, who was invited by the meeting organizers to comment on the work.

“My biggest concern is that even though this rule will do a good job at minimizing surgeries, what it's not doing a good job of is finding early-stage cancer,” said Dr. Urban of the Seattle-based Fred Hutchinson Cancer Center. “There are many people who were hoping that ultrasound would work better than this.”

PALM SPRINGS, CALIF. — The best predictor for ovarian malignancy in a postmenopausal woman with an initial abnormal screen is a CA 125 level of 65 U/mL or greater, Dr. Edward E. Partridge said at the annual meeting of the Society of Gynecologic Oncologists.

He also reported that in women who have a follow-up screen, these four criteria, in hierarchical order, appear to be accurate in detecting malignancy: a CA 125 level of 65 U/mL or greater; a CA 125 increase of 40 points or more; a CA 125 change of 10 points with an ovary and/or cyst 3 cm or greater in size; or an ovary/cyst change of 6.5 cm or more.

The findings are based on an analysis of data from the first 3 years of the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

“This should provide some guidance for clinical decisions regarding the need for surgery and/or appropriate referral for asymptomatic postmenopausal women with abnormal findings on CA-125 and/or transvaginal ultrasound,” said Dr. Partridge, associate director of cancer prevention and control at the University of Alabama, Birmingham, and director of the UAB Comprehensive Cancer Center.

However, he was quick to note that he does not recommend the routine clinical use of CA 125 and transvaginal ultrasound to detect ovarian cancer in asymptomatic postmenopausal women at this time. “We are not encouraging these tests until the trial is complete,” he said. “If one does have these tests it gives some reassurance that you do not have to undergo an operative procedure if these criteria are not met.”

Although the study is the largest of its kind to date, the criteria used in the analysis “are empirically based and represent one approach to combine the criteria,” Dr. Partridge added. “The model has not been validated in a separate, similar population. Therefore it may be overly optimistic in its predictability.”

The purpose of the study was to quantify and characterize the occurrence of ovarian malignancy among 28,506 women aged 55–74 years in the Prostate, Lung, Colon, and Ovarian Cancer Screening Trial who underwent both CA 125 and transvaginal ultrasound at their initial evaluation and during subsequent screening years 1–3.

“The major objective from a clinical standpoint was to establish clinically useful criteria to assess the likelihood of finding a malignancy after an abnormal screen,” he said.

A positive screen was defined as a CA 125 level of 65 U/mL or greater; ovarian or cyst volume of greater than 10 cm

At the baseline screen, the researchers analyzed the relationship of the following factors to ovarian cancer detection: age, race, family history, CA 125 level, maximum ovary/cyst diameter, presence of mixed/irregular/papillary features, and presence of a solid mass.

They analyzed the relationship of these factors to positive screens from subsequent years as well, plus the change in CA 125 level and the change in ovary/cyst size from the previous negative screen.

Dr. Partridge and his associates found that the best predictor for malignancy in a woman with an abnormal baseline screen is a CA 125 level of 65 U/mL or greater. Using this criterion, the researchers would have been able to detect 15 of the 20 cancers found in that cohort of women. This would have required 71 operative procedures and yielded a positive predictive value of 21%.

In women who have a follow-up screen, researchers using the four criteria of CA 125 level, CA 125 increase, CA 125 point increase with ovary/cyst 3 cm or greater in size, or an ovary/cyst change of 6.5 cm or more would have been able to detect all 29 cancers found in this cohort.

“This is very useful information,” said Dr. Nicole Urban, who was invited by the meeting organizers to comment on the work.

“My biggest concern is that even though this rule will do a good job at minimizing surgeries, what it's not doing a good job of is finding early-stage cancer,” said Dr. Urban of the Seattle-based Fred Hutchinson Cancer Center. “There are many people who were hoping that ultrasound would work better than this.”

Patients with multinodular goiter required a thyroxine dosage increase of 22%–34% if they had impaired secretion of stomach acids, results from a large controlled study demonstrated.

The finding suggests that “normal gastric acid secretion is important for the subsequent intestinal absorption of thyroxine,” wrote the researchers, who were led by Dr. Marco Centanni, of the department of experimental medicine and pathology at La Sapienza University, Rome.

“Although the clinical importance of these findings is fairly clear, the mechanism by which intestinal absorption of thyroxine is impaired in patients with hypochlorhydria is unknown. We may only speculate that oral thyroxine is administered as sodium salt that is less lipophilic than the native hormone, which enters target cells both through passive diffusion and in a carrier-mediated, inhibitable way. In this respect, achlorhydria due to atrophic gastritis, the production of ammonia, or both, which are characteristic of [Helicobacter] pylori infection, may alter the ionization status and the conformational characteristics of the thyroxine molecule and thus the efficiency of intestinal absorption of the hormone.”

Dr. Centanni and his associates studied 248 patients with nontoxic multinodular goiter who were seen at a referral center between 1999 and 2004. Of the 248 patients, 53 also had H. pylori-related gastritis and 60 had atrophic gastritis of the body of the stomach (31 with evidence of H. pylori infection and 29 without such evidence). The remaining 135 patients had no gastric disorders and served as the reference group (N. Engl. J. Med. 2006;354:1787–95).

All patients received an initial thyroxine dose of 50 mcg/day and were followed for at least 30 months. The researchers evaluated the thyroid-pituitary axis every 4 months and, if needed, increased the thyroxine dose until a low serum thyrotropin level was achieved on at least two consecutive measurements. The serum thyrotropin level was considered low if it was between 0.05 and 0.20 mU/L.

The researchers also studied the levels of serum thyrotropin in 11 women diagnosed with H. pylori infection 4–19 months after the study began, and in 10 women diagnosed with gastroesophageal reflux disease. These 10 women were given omeprazole along with thyroxine. Serum thyrotropin levels continued to be measured after treatment with omeprazole began.

Compared with patients in the reference group, all patients who had impaired secretion of gastric acid required statistically significant increases in their daily doses of thyroxine in order to achieve low levels of serum thyrotropin. The median thyroxine dose required of the 53 patients with H. pylori-related gastritis was 125 mcg/day, which was a 22% median increase from that of the referent group.

The median thyroxine dose required of the 60 patients with atrophic gastritis of the body of the stomach also was 125 mcg/day, which was a 27% median increase from that of the referent group. (Those with evidence of H. pylori infection required a median thyroxine dose of 150 mcg/day, a median increase of 34% from that of the referent group, while those without such evidence required a median thyroxine dose of 125 mcg/day, a median increase of 24% from that of the referent group.)

Serum thyrotropin levels rose variably in the cohort of 11 women with newly diagnosed H. pylori infection.

“In some patients, a slightly higher dose of thyroxine was needed to restore thyrotropin suppression,” the researchers wrote. “Likewise, the increase in the level of serum thyrotropin was variable in patients treated with omeprazole, although the suppressive effect of thyroxine on thyrotropin disappeared in all patients and was restored only at a substantially higher dose of thyroxine.”

The authors noted that the reversible effect of omeprazole “further supports the hypothesis that normal gastric acid secretion is necessary for effective intestinal absorption of thyroxine.”

Patients with multinodular goiter required a thyroxine dosage increase of 22%–34% if they had impaired secretion of stomach acids, results from a large controlled study demonstrated.

The finding suggests that “normal gastric acid secretion is important for the subsequent intestinal absorption of thyroxine,” wrote the researchers, who were led by Dr. Marco Centanni, of the department of experimental medicine and pathology at La Sapienza University, Rome.

“Although the clinical importance of these findings is fairly clear, the mechanism by which intestinal absorption of thyroxine is impaired in patients with hypochlorhydria is unknown. We may only speculate that oral thyroxine is administered as sodium salt that is less lipophilic than the native hormone, which enters target cells both through passive diffusion and in a carrier-mediated, inhibitable way. In this respect, achlorhydria due to atrophic gastritis, the production of ammonia, or both, which are characteristic of [Helicobacter] pylori infection, may alter the ionization status and the conformational characteristics of the thyroxine molecule and thus the efficiency of intestinal absorption of the hormone.”

Dr. Centanni and his associates studied 248 patients with nontoxic multinodular goiter who were seen at a referral center between 1999 and 2004. Of the 248 patients, 53 also had H. pylori-related gastritis and 60 had atrophic gastritis of the body of the stomach (31 with evidence of H. pylori infection and 29 without such evidence). The remaining 135 patients had no gastric disorders and served as the reference group (N. Engl. J. Med. 2006;354:1787–95).

All patients received an initial thyroxine dose of 50 mcg/day and were followed for at least 30 months. The researchers evaluated the thyroid-pituitary axis every 4 months and, if needed, increased the thyroxine dose until a low serum thyrotropin level was achieved on at least two consecutive measurements. The serum thyrotropin level was considered low if it was between 0.05 and 0.20 mU/L.

The researchers also studied the levels of serum thyrotropin in 11 women diagnosed with H. pylori infection 4–19 months after the study began, and in 10 women diagnosed with gastroesophageal reflux disease. These 10 women were given omeprazole along with thyroxine. Serum thyrotropin levels continued to be measured after treatment with omeprazole began.

Compared with patients in the reference group, all patients who had impaired secretion of gastric acid required statistically significant increases in their daily doses of thyroxine in order to achieve low levels of serum thyrotropin. The median thyroxine dose required of the 53 patients with H. pylori-related gastritis was 125 mcg/day, which was a 22% median increase from that of the referent group.

The median thyroxine dose required of the 60 patients with atrophic gastritis of the body of the stomach also was 125 mcg/day, which was a 27% median increase from that of the referent group. (Those with evidence of H. pylori infection required a median thyroxine dose of 150 mcg/day, a median increase of 34% from that of the referent group, while those without such evidence required a median thyroxine dose of 125 mcg/day, a median increase of 24% from that of the referent group.)

Serum thyrotropin levels rose variably in the cohort of 11 women with newly diagnosed H. pylori infection.

“In some patients, a slightly higher dose of thyroxine was needed to restore thyrotropin suppression,” the researchers wrote. “Likewise, the increase in the level of serum thyrotropin was variable in patients treated with omeprazole, although the suppressive effect of thyroxine on thyrotropin disappeared in all patients and was restored only at a substantially higher dose of thyroxine.”

The authors noted that the reversible effect of omeprazole “further supports the hypothesis that normal gastric acid secretion is necessary for effective intestinal absorption of thyroxine.”

Patients with multinodular goiter required a thyroxine dosage increase of 22%–34% if they had impaired secretion of stomach acids, results from a large controlled study demonstrated.

The finding suggests that “normal gastric acid secretion is important for the subsequent intestinal absorption of thyroxine,” wrote the researchers, who were led by Dr. Marco Centanni, of the department of experimental medicine and pathology at La Sapienza University, Rome.

“Although the clinical importance of these findings is fairly clear, the mechanism by which intestinal absorption of thyroxine is impaired in patients with hypochlorhydria is unknown. We may only speculate that oral thyroxine is administered as sodium salt that is less lipophilic than the native hormone, which enters target cells both through passive diffusion and in a carrier-mediated, inhibitable way. In this respect, achlorhydria due to atrophic gastritis, the production of ammonia, or both, which are characteristic of [Helicobacter] pylori infection, may alter the ionization status and the conformational characteristics of the thyroxine molecule and thus the efficiency of intestinal absorption of the hormone.”

Dr. Centanni and his associates studied 248 patients with nontoxic multinodular goiter who were seen at a referral center between 1999 and 2004. Of the 248 patients, 53 also had H. pylori-related gastritis and 60 had atrophic gastritis of the body of the stomach (31 with evidence of H. pylori infection and 29 without such evidence). The remaining 135 patients had no gastric disorders and served as the reference group (N. Engl. J. Med. 2006;354:1787–95).

All patients received an initial thyroxine dose of 50 mcg/day and were followed for at least 30 months. The researchers evaluated the thyroid-pituitary axis every 4 months and, if needed, increased the thyroxine dose until a low serum thyrotropin level was achieved on at least two consecutive measurements. The serum thyrotropin level was considered low if it was between 0.05 and 0.20 mU/L.

The researchers also studied the levels of serum thyrotropin in 11 women diagnosed with H. pylori infection 4–19 months after the study began, and in 10 women diagnosed with gastroesophageal reflux disease. These 10 women were given omeprazole along with thyroxine. Serum thyrotropin levels continued to be measured after treatment with omeprazole began.

Compared with patients in the reference group, all patients who had impaired secretion of gastric acid required statistically significant increases in their daily doses of thyroxine in order to achieve low levels of serum thyrotropin. The median thyroxine dose required of the 53 patients with H. pylori-related gastritis was 125 mcg/day, which was a 22% median increase from that of the referent group.

The median thyroxine dose required of the 60 patients with atrophic gastritis of the body of the stomach also was 125 mcg/day, which was a 27% median increase from that of the referent group. (Those with evidence of H. pylori infection required a median thyroxine dose of 150 mcg/day, a median increase of 34% from that of the referent group, while those without such evidence required a median thyroxine dose of 125 mcg/day, a median increase of 24% from that of the referent group.)

Serum thyrotropin levels rose variably in the cohort of 11 women with newly diagnosed H. pylori infection.

“In some patients, a slightly higher dose of thyroxine was needed to restore thyrotropin suppression,” the researchers wrote. “Likewise, the increase in the level of serum thyrotropin was variable in patients treated with omeprazole, although the suppressive effect of thyroxine on thyrotropin disappeared in all patients and was restored only at a substantially higher dose of thyroxine.”

The authors noted that the reversible effect of omeprazole “further supports the hypothesis that normal gastric acid secretion is necessary for effective intestinal absorption of thyroxine.”