Grumpy Old Docs Not Quite As Grumpy
Posted by Jacob Goldstein
Sure, old docs say things aren’t like they good old days. But veteran M.D.s may not be quite as sour about the state of doctoring as they were a few years back.
Look closely at the graphic at right and you’ll see that in a recent survey of docs age 50 to 65, just over half of respondents said the practice of medicine has become less satisfying in the past five years.
Not great, you say, but that’s a heck of a lot better than the 76% who answered that way in a similar survey in 2004. And the group of docs who actually said things got better jumped to 24% this year from 9% in 2004.
“That one’s a head scratcher,” Phil Miller, spokesman for Merritt Hawkins, the physician headhunter firm that did the surveys, told the Health Blog. But he was able to suggest a few possible reasons for the improvement — legal reforms have made malpractice less onerous in some states, and docs have a little more autonomy in some managed-care settings these days.
The survey went out to 10,000 docs, and 1,175 responded. It included several sections, including one that queried the older docs about young M.D.s entering the profession today. Answers on that front didn’t change much between 2004 and 2007. In both cases, more than 60% of docs said young physicians are less dedicated and hard working than the older generation. Hippocrates’ teacher probably said the same thing. But the surveys don’t go back that far.
Sunday, October 28, 2007
Tougher Avandia Warning Is Urged
New Label for DrugWould Detail RiskOf Heart Attack
By ANNA WILDE MATHEWSOctober 24, 2007; Page A14
The Food and Drug Administration wants GlaxoSmithKline PLC to add the strongest form of safety warning about heart-attack risk to the label of its diabetes drug Avandia, according to people with knowledge of the matter, a move that would compound the commercial woes of the once-popular medication.
Agency officials are pushing for a "black box" warning, these people say. The new label is still being discussed with the company and its final form isn't yet clear. In high-profile safety matters, the agency tends to have strong leverage.
The new warning would be a blow to GlaxoSmithKline, which had said there isn't clear evidence Avandia is more dangerous than competitors. Avandia already carries a black-box warning about a different side effect -- heart failure -- but a heart-attack warning would be more serious. Avandia's main rival drug, Takeda Pharmaceutical Co.'s Actos, carries a heart-failure caution, but doesn't have one for heart-attack risk.
An FDA spokeswoman said the agency "is still involved in internal discussions on this matter" and that when there is a final decision it will become public. A GlaxoSmithKline spokeswoman said the company is "working diligently with the FDA to finalize the label, but it would be inappropriate for us to discuss the ongoing conversations with the agency."
The new label warning would represent the latest reversal for Avandia, Glaxo's second biggest-selling drug last year, with global sales of $3.38 billion, or 7% of the United Kingdom company's total sales. Avandia's prescriptions plunged after a medical journal article by Cleveland Clinic cardiologist Steven Nissen in May raised concerns about its possible heart risk.
If it goes into effect, the new warning would focus on Avandia's potential for increased ischemic risk: a risk of events in which blood is choked off from the heart. An FDA analysis that crunched together multiple Avandia studies found that the drug appeared to be linked to a 38% higher risk of ischemic events. The company has said that such analyses aren't typically considered the strongest form of medical evidence, and that other data didn't show a similar risk.
A black-box warning would still represent something of a middle ground in the debate over Avandia. During a public meeting in July, some FDA officials said the drug should no longer be sold in the U.S. because of the potential heart danger. A committee of FDA advisers, though, voted that it should remain on the market, even though the panel said the drug was tied to increased ischemic risk.
Avandia's woes would likely benefit Actos. Doctors may also look at older medications such as metformin and newer options such as Merck & Co.'s Januvia.
The potential Avandia label-change has played out amid pressure from outside researchers and scrutiny from Capitol Hill. In June, there was a congressional hearing focused on the drug's safety, and the FDA's handling of it. The drug is the subject of continuing investigations by lawmakers.
Separately, Glaxo and Mylan Inc. yesterday agreed to settle a patent dispute over the antidepressant Paxil CR. As part of the deal, Mylan, a U.S. maker of generics, will have the right to market its version of Glaxo's drug, generically known as paroxetine hydrochloride, beginning no later than Oct. 1, 2008.
New Label for DrugWould Detail RiskOf Heart Attack
By ANNA WILDE MATHEWSOctober 24, 2007; Page A14
The Food and Drug Administration wants GlaxoSmithKline PLC to add the strongest form of safety warning about heart-attack risk to the label of its diabetes drug Avandia, according to people with knowledge of the matter, a move that would compound the commercial woes of the once-popular medication.
Agency officials are pushing for a "black box" warning, these people say. The new label is still being discussed with the company and its final form isn't yet clear. In high-profile safety matters, the agency tends to have strong leverage.
The new warning would be a blow to GlaxoSmithKline, which had said there isn't clear evidence Avandia is more dangerous than competitors. Avandia already carries a black-box warning about a different side effect -- heart failure -- but a heart-attack warning would be more serious. Avandia's main rival drug, Takeda Pharmaceutical Co.'s Actos, carries a heart-failure caution, but doesn't have one for heart-attack risk.
An FDA spokeswoman said the agency "is still involved in internal discussions on this matter" and that when there is a final decision it will become public. A GlaxoSmithKline spokeswoman said the company is "working diligently with the FDA to finalize the label, but it would be inappropriate for us to discuss the ongoing conversations with the agency."
The new label warning would represent the latest reversal for Avandia, Glaxo's second biggest-selling drug last year, with global sales of $3.38 billion, or 7% of the United Kingdom company's total sales. Avandia's prescriptions plunged after a medical journal article by Cleveland Clinic cardiologist Steven Nissen in May raised concerns about its possible heart risk.
If it goes into effect, the new warning would focus on Avandia's potential for increased ischemic risk: a risk of events in which blood is choked off from the heart. An FDA analysis that crunched together multiple Avandia studies found that the drug appeared to be linked to a 38% higher risk of ischemic events. The company has said that such analyses aren't typically considered the strongest form of medical evidence, and that other data didn't show a similar risk.
A black-box warning would still represent something of a middle ground in the debate over Avandia. During a public meeting in July, some FDA officials said the drug should no longer be sold in the U.S. because of the potential heart danger. A committee of FDA advisers, though, voted that it should remain on the market, even though the panel said the drug was tied to increased ischemic risk.
Avandia's woes would likely benefit Actos. Doctors may also look at older medications such as metformin and newer options such as Merck & Co.'s Januvia.
The potential Avandia label-change has played out amid pressure from outside researchers and scrutiny from Capitol Hill. In June, there was a congressional hearing focused on the drug's safety, and the FDA's handling of it. The drug is the subject of continuing investigations by lawmakers.
Separately, Glaxo and Mylan Inc. yesterday agreed to settle a patent dispute over the antidepressant Paxil CR. As part of the deal, Mylan, a U.S. maker of generics, will have the right to market its version of Glaxo's drug, generically known as paroxetine hydrochloride, beginning no later than Oct. 1, 2008.
Saturday, October 27, 2007
AACR-NCI-EORTC: Sunitinib Shows Early Promise in Liver Cancer
SAN FRANCISCO, Oct. 26 -- Sunitinib (Sutent) appears to be effective in advanced hepatocellular cancer, according to a small study.A preliminary analysis showed antitumor activity, including an average 39% decrease in tumor blood vessel permeability after two weeks of sunitinib therapy, Andrew X. Zhu, M.D., Ph.D., of Massachusetts General Hospital Cancer Center and Harvard, and colleagues, reported here at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
Although it is too early to say whether the findings are relevant to inhibition of the tumor itself, Dr. Zhu called them "very, very encouraging."
"We know that hepatocellular carcinoma is very vascular," Dr. Zhu said. "We have actually postulated that antiangiogenesis may be a very important strategy to inhibit the cancer growth in this type of malignancy."
Hepatocellular cancer has been associated in previous studies with increased levels of angiogenic factors, which sunitinib is designed to block.
Sunitinib is FDA approved only for treatment of advanced renal cell carcinoma and gastrointestinal stromal tumor, and a similar receptor tyrosine kinase inhibitor, sorafenib (Nexavar), is under review by the FDA for treatment of hepatocellular carcinoma after demonstrating improved survival in clinical trials.
So, the researchers evaluated efficacy, toxicity, and angiogenic parameter changes with sunitinib among 31 patients with unresectable or metastatic measurable hepatocellular carcinoma who had undergone no more than one prior chemotherapy regimen and had adequate organ function.
Participants in the phase II study received sunitinib at 37.5 mg a day for four weeks followed by a standard six-week cycle regimen. They were evaluated with dynamic contrast-enhanced MRI and multiplex protein array.
After an average follow-up of 15 months from enrollment, the average progression-free survival was four months. This is "in the same neighborhood" as the 4.5-month median progression-free survival seen in the trial of sorafenib for hepatocellular carcinoma, Dr. Zhu said.
Cancer stabilized in 10 patients for at least three months, and one patient had a partial response.
There were also preliminary signs of antiangiogenic activity in the subset of patients who were evaluated for these endpoints.
Vascular endothelial growth factor (VEGF) levels had increased in 14 of 18 patients on day 15. Levels of placental growth factor (PIGF) increased in all 18 patients.
However, the basic fibroblast growth factors were decreased in 11 patients on day 15. VEGFR2 was also decreased in 14 of 15 patients. Viable circulating progenitor cells evaluated by flow cytometry in fresh whole blood samples were also decreased (P<0.01), which "may affect angiogenesis more profoundly," Dr. Zhu said.
"The key for us is determining whether any of the changes are relevant to the antiangiogenesis pathway," he said.
The treatment was generally well tolerated, he added, with less than 20% of patients experiencing grade 3 toxicity in any category. These included 16% leukopenia, 16% lymphopenia, 10% fatigue, 19% elevated aspartate transaminase (AST), 6% elevated alanine transaminase (ALT), 6% skin rash, 6% hand-foot syndrome, and 6% thrombocytopenia.
The only grade 4 toxicity was thrombocytopenia in 6% of patients.
"Sunitinib administered in the current dose schedule can be safely given with close monitoring in the majority of hepatocellular carcinoma patients," the researchers said.
"Sunitinib clearly is modifying the disease in this specific patient population," Dr. Zhu concluded. But, he noted, "whether this drug will eventually prove to be effective in hepatocellular carcinoma clearly requires rigorous testing in future large studies."
The study was funded by Pfizer, manufacturer of sunitinib. Dr. Zhu reported no relevant conflicts of interest. Primary source: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Source reference: Zhu AX, et al "Efficacy, safety, and changes in angiogenic markers following sunitinib monotherapy in patients with advanced hepatocellular carcinoma: Experience from a phase II study" AACR-NCI-EORTC meeting 2007; Abstract PR7.
SAN FRANCISCO, Oct. 26 -- Sunitinib (Sutent) appears to be effective in advanced hepatocellular cancer, according to a small study.A preliminary analysis showed antitumor activity, including an average 39% decrease in tumor blood vessel permeability after two weeks of sunitinib therapy, Andrew X. Zhu, M.D., Ph.D., of Massachusetts General Hospital Cancer Center and Harvard, and colleagues, reported here at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
Although it is too early to say whether the findings are relevant to inhibition of the tumor itself, Dr. Zhu called them "very, very encouraging."
"We know that hepatocellular carcinoma is very vascular," Dr. Zhu said. "We have actually postulated that antiangiogenesis may be a very important strategy to inhibit the cancer growth in this type of malignancy."
Hepatocellular cancer has been associated in previous studies with increased levels of angiogenic factors, which sunitinib is designed to block.
Sunitinib is FDA approved only for treatment of advanced renal cell carcinoma and gastrointestinal stromal tumor, and a similar receptor tyrosine kinase inhibitor, sorafenib (Nexavar), is under review by the FDA for treatment of hepatocellular carcinoma after demonstrating improved survival in clinical trials.
So, the researchers evaluated efficacy, toxicity, and angiogenic parameter changes with sunitinib among 31 patients with unresectable or metastatic measurable hepatocellular carcinoma who had undergone no more than one prior chemotherapy regimen and had adequate organ function.
Participants in the phase II study received sunitinib at 37.5 mg a day for four weeks followed by a standard six-week cycle regimen. They were evaluated with dynamic contrast-enhanced MRI and multiplex protein array.
After an average follow-up of 15 months from enrollment, the average progression-free survival was four months. This is "in the same neighborhood" as the 4.5-month median progression-free survival seen in the trial of sorafenib for hepatocellular carcinoma, Dr. Zhu said.
Cancer stabilized in 10 patients for at least three months, and one patient had a partial response.
There were also preliminary signs of antiangiogenic activity in the subset of patients who were evaluated for these endpoints.
Vascular endothelial growth factor (VEGF) levels had increased in 14 of 18 patients on day 15. Levels of placental growth factor (PIGF) increased in all 18 patients.
However, the basic fibroblast growth factors were decreased in 11 patients on day 15. VEGFR2 was also decreased in 14 of 15 patients. Viable circulating progenitor cells evaluated by flow cytometry in fresh whole blood samples were also decreased (P<0.01), which "may affect angiogenesis more profoundly," Dr. Zhu said.
"The key for us is determining whether any of the changes are relevant to the antiangiogenesis pathway," he said.
The treatment was generally well tolerated, he added, with less than 20% of patients experiencing grade 3 toxicity in any category. These included 16% leukopenia, 16% lymphopenia, 10% fatigue, 19% elevated aspartate transaminase (AST), 6% elevated alanine transaminase (ALT), 6% skin rash, 6% hand-foot syndrome, and 6% thrombocytopenia.
The only grade 4 toxicity was thrombocytopenia in 6% of patients.
"Sunitinib administered in the current dose schedule can be safely given with close monitoring in the majority of hepatocellular carcinoma patients," the researchers said.
"Sunitinib clearly is modifying the disease in this specific patient population," Dr. Zhu concluded. But, he noted, "whether this drug will eventually prove to be effective in hepatocellular carcinoma clearly requires rigorous testing in future large studies."
The study was funded by Pfizer, manufacturer of sunitinib. Dr. Zhu reported no relevant conflicts of interest. Primary source: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Source reference: Zhu AX, et al "Efficacy, safety, and changes in angiogenic markers following sunitinib monotherapy in patients with advanced hepatocellular carcinoma: Experience from a phase II study" AACR-NCI-EORTC meeting 2007; Abstract PR7.
Hormonal Effects of Antiepileptic Drugs are Reversible
LORENSKOG, Norway, Oct. 26 -- Common antiepileptic drugs can negatively affect reproductive endocrine function, but the changes may be reversible even after years of chronic use, investigators here reported.
In a randomized double-blind study, both men and women who were withdrawn from carbamazepine, for example, had significant increases in serum testosterone and free androgen index compared with patients who stayed on the drug, reported Morten Lossius, M.D., of Akershus University Hospital and the National Center for Epilepsy, and colleagues.
"The increase in the free androgen index found in the present study shows that the decrease in free androgen index associated with carbamazepine treatment is reversible," the authors wrote in the October issue of Epilepsia.
The study evaluated the effects of antiepileptic drug withdrawal on reproductive endocrine function -- specifically, whether the known suppressive effects of the drugs on endocrine function could be partially or fully reversible.
The investigators studied 70 men and 80 women from the ages of 18 to 67 who had epilepsy (defined as at least two unprovoked seizures) and who had been seizure-free for at least two years while on antiepileptic drug monotherapy.
The patients were randomly assigned to drug withdrawal via dose reduction and placebo substitution, or no withdrawal.
Blood samples were taken and evaluated at baseline and at four months after the time of complete withdrawal (or no withdrawal) for total testosterone, 17-beta-estradiol, progesterone, sex hormone binding globulin, follicle stimulating hormone, luteinizing hormone, free androgen index, insulin, estradiol/sex hormone binding globulin ratio and C-peptide.
Complete before-and-after serum samples for 130 patients were available for analysis at the end of the one-year study.
"The main finding was that reversible endocrine changes in sex steroid hormone levels could be observed in both sexes after withdrawal of antiepileptic drugs," the authors wrote.
Patients assigned to carbamazepine withdrawal had significant increases in serum testosterone concentrations (P=0.001) and free androgen index in both men and women (19 in each group).
Mean differences in change in the free androgen index between the withdrawal group and nonwithdrawal group were 17.49 (95% confidence interval, 10.16 to 24.81, P ≤ 0.001) in men, and 1.61 (95% CI, 0.62-2.61, P ≤ 0.001) in women.
"Our findings provide further evidence of the potentially negative effects of carbamazepine treatment on reproductive endocrine functions in men and women, but also show that some of these changes may be reversible, even after years on treatment," the authors wrote.
The numbers of both men and women on valproic acid (Depakene, Depakote) were too small to draw statistically significant conclusions about the effects of withdrawal on endocrine levels, they noted.
Neither the study funding source nor author conflicts of interest were listed. Primary source: EpilepsiaSource reference: Lossius MI, et al "Reversible Effects of Antiepileptic Drugs on Reproductive Endocrine Function in Men and Women with Epilepsy-A Prospective Randomized Double-blind Withdrawal Study." Epilepsia 48; 10: 1875-1882.
LORENSKOG, Norway, Oct. 26 -- Common antiepileptic drugs can negatively affect reproductive endocrine function, but the changes may be reversible even after years of chronic use, investigators here reported.
In a randomized double-blind study, both men and women who were withdrawn from carbamazepine, for example, had significant increases in serum testosterone and free androgen index compared with patients who stayed on the drug, reported Morten Lossius, M.D., of Akershus University Hospital and the National Center for Epilepsy, and colleagues.
"The increase in the free androgen index found in the present study shows that the decrease in free androgen index associated with carbamazepine treatment is reversible," the authors wrote in the October issue of Epilepsia.
The study evaluated the effects of antiepileptic drug withdrawal on reproductive endocrine function -- specifically, whether the known suppressive effects of the drugs on endocrine function could be partially or fully reversible.
The investigators studied 70 men and 80 women from the ages of 18 to 67 who had epilepsy (defined as at least two unprovoked seizures) and who had been seizure-free for at least two years while on antiepileptic drug monotherapy.
The patients were randomly assigned to drug withdrawal via dose reduction and placebo substitution, or no withdrawal.
Blood samples were taken and evaluated at baseline and at four months after the time of complete withdrawal (or no withdrawal) for total testosterone, 17-beta-estradiol, progesterone, sex hormone binding globulin, follicle stimulating hormone, luteinizing hormone, free androgen index, insulin, estradiol/sex hormone binding globulin ratio and C-peptide.
Complete before-and-after serum samples for 130 patients were available for analysis at the end of the one-year study.
"The main finding was that reversible endocrine changes in sex steroid hormone levels could be observed in both sexes after withdrawal of antiepileptic drugs," the authors wrote.
Patients assigned to carbamazepine withdrawal had significant increases in serum testosterone concentrations (P=0.001) and free androgen index in both men and women (19 in each group).
Mean differences in change in the free androgen index between the withdrawal group and nonwithdrawal group were 17.49 (95% confidence interval, 10.16 to 24.81, P ≤ 0.001) in men, and 1.61 (95% CI, 0.62-2.61, P ≤ 0.001) in women.
"Our findings provide further evidence of the potentially negative effects of carbamazepine treatment on reproductive endocrine functions in men and women, but also show that some of these changes may be reversible, even after years on treatment," the authors wrote.
The numbers of both men and women on valproic acid (Depakene, Depakote) were too small to draw statistically significant conclusions about the effects of withdrawal on endocrine levels, they noted.
Neither the study funding source nor author conflicts of interest were listed. Primary source: EpilepsiaSource reference: Lossius MI, et al "Reversible Effects of Antiepileptic Drugs on Reproductive Endocrine Function in Men and Women with Epilepsy-A Prospective Randomized Double-blind Withdrawal Study." Epilepsia 48; 10: 1875-1882.
TCT: Drug-Coated Balloons Promoted as a Back-to-the-Future Approach to Restenosis
WASHINGTON, Oct. 26 -- Old-style balloon angioplasty married to the latest in drug-eluting technology may be an effective alternative to stenting, according to a pair of small studies from two German centers.In a small study called PEPCAD II-ISR, in-stent restenosis patients treated with an investigational paclitaxel-eluting balloon (SeQuent Please) had a lower major adverse cardiovascular event rate (MACE), less late lumen loss, a lower binary restenosis rate, and less need for target lesion revascularization than patients treated with a paclitaxel-eluting stent (Taxus), said Martin Unverdorben, M.D., of the Clinical Research Institute at the Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
And the paclitaxel-coated balloon demonstrated similar six-month efficacy in patients with small vessel disease, said Dr. Unverdorben, who reported results of the PEPCAD (Paclitaxel-Eluting-PTCA-Balloon Catheter in Coronary Artery Disease)-I-SVD and PEPCAD II-ISR trials at the Transcatheter Cardiovascular Therapeutics meeting here.
Those results echoed positive findings from the PACCOCATH investigators who reported two-year results from their first-in-man studies of a paclitaxel-eluting balloon (Paccocath) for treatment of in-stent restenosis.
After two years, patients treated with the paclitaxel-coated balloon had significantly fewer major adverse cardiovascular events (MACE) (P=0.001) and a significantly lower target lesion revascularization rate for patients treated with the drug-coated balloon versus the uncoated balloon (P=0.001), said Bruno Scheller, M.D., of Saarland University Hospital in Homburg.
PEPCAD Slide Presentationby Martin Unverdorben, M.D.(Running time: apprx. 2 minutes)Slides are also available for complimentary download(top right of this page)
Dr. Scheller's findings, also reported at TCT, confirmed 12-month PACCOCATH results reported at the American Heart Association meeting last November and published in the New England Journal of Medicine. But Jeffrey Popma, M.D., of Caritas Christi Health Care System and Harvard Medical School, said that both studies used an inaccurate measure for gauging outcome by reporting late lumen loss.
The notion of late lumen loss, he said, was developed as an efficacy measure for stents because the gain in stents was so great as the stent expands and pushes back the vessel wall to expand the lumen, there was also concern that a recoil or natural shrinking effect would follow that great gain. Late lumen loss was developed as a measure of that shrinking.
But balloons, even a drug-coated balloon, do not achieve as great an initial gain as stents, so the loss or recoil would naturally not be as great, Dr. Popma said.
He urged the researchers to recalculate their data using methods specifically developed for assessment of balloon efficacy -- initial gain and loss index -- rather than relying on a late lumen loss, which is applicable only to stents.
That criticism aside, Dr. Popma, who served as commentator during a TCT press briefing where both studies were discussed, said he believed drug-coated ballons would prove to be an effective option for patients who were not good candidates for drug-eluting stents.
"Because the balloon delivers the drug relatively quickly and is then removed, there would be no need for extended dual anti-platelet therapy, so this might be useful for patients who are not good candidates for 12 months of clopidogrel (Plavix) plus aspirin," he said.
PEPCAD II-ISR enrolled 131 patients and Dr. Unverdorben reported six month outcomes for 66 drug-eluting balloon patients and 60 drug-eluting stent patients.
Among the findings:
Late lumen loss was 0.19 mm in the drug-coated balloon arm versus 0.45 mm in the drug-eluting stent arm (P=0.01).
Binary restenosis in segment rate was 3.7% in the balloon arm versus 20.8% in the stent group (P=0.02).
MACE rate was 4.8% in the balloon arm versus 22% in the stent arm (P=0.007).
Target lesion revascularization rate in the balloon arm was 3.2% versus 18.6% in the stent group (P=0.008).
There were no myocardial infarctions and one death in the balloon group versus one MI and one death in the stent group (NS).
Dr. Scheller and colleagues randomized 54 patients with in-stent restenosis to angioplasty with uncoated balloons and 54 to angioplasty with paclitaxel-coated balloons.
The 24-month clinical follow-up found:
The target lesion revascularization rate was 37% for patients treated with uncoated balloons versus 6% for patients treated with drug-coated balloons (P=0.001).
There were five MIs and three deaths in the uncoated balloon group versus one MI and one death in the drug-coated balloon arm (NS).
There were three strokes in the control arm versus two in the paclitaxel-coated balloon arm (NS).
The overall MACE rate was 46% in the control arm versus 11% in the drug-coated balloon group (P=0.001).
The PEPCAD study was funded by B. Braun Melsungen AG, which is developing the SeQuent Please balloon catheter. Dr. Umverdorben reported no financial disclosures. The PACCOCATH trial was funded by Bavaria Medizin Technologie. Dr. Scheller reported being a co-inventor on a patent application for the balloon used in the PACCOCATH trial. Dr. Popma reported financial support from Cordis Corporation, Boston Scientific Corporation, Medtronic, Abbott Vascular, ev3, Gore & Associates, Sanofi-Aventis, The Medicines Company, Bristol-Myers Squibb, and Pfizer. Additional source: Transcatheter Cardiovascular TherapeuticsSource reference: Unverdorben M, et al "The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease" PEPCAD II-ISR Late-Breaking Clinical Trials. Additional source: Transcatheter Cardiovascular TherapeuticsSource reference: Scheller B, et al "PACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis: 2-Year Results" Late Breaking Clinical Trials.
WASHINGTON, Oct. 26 -- Old-style balloon angioplasty married to the latest in drug-eluting technology may be an effective alternative to stenting, according to a pair of small studies from two German centers.In a small study called PEPCAD II-ISR, in-stent restenosis patients treated with an investigational paclitaxel-eluting balloon (SeQuent Please) had a lower major adverse cardiovascular event rate (MACE), less late lumen loss, a lower binary restenosis rate, and less need for target lesion revascularization than patients treated with a paclitaxel-eluting stent (Taxus), said Martin Unverdorben, M.D., of the Clinical Research Institute at the Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
And the paclitaxel-coated balloon demonstrated similar six-month efficacy in patients with small vessel disease, said Dr. Unverdorben, who reported results of the PEPCAD (Paclitaxel-Eluting-PTCA-Balloon Catheter in Coronary Artery Disease)-I-SVD and PEPCAD II-ISR trials at the Transcatheter Cardiovascular Therapeutics meeting here.
Those results echoed positive findings from the PACCOCATH investigators who reported two-year results from their first-in-man studies of a paclitaxel-eluting balloon (Paccocath) for treatment of in-stent restenosis.
After two years, patients treated with the paclitaxel-coated balloon had significantly fewer major adverse cardiovascular events (MACE) (P=0.001) and a significantly lower target lesion revascularization rate for patients treated with the drug-coated balloon versus the uncoated balloon (P=0.001), said Bruno Scheller, M.D., of Saarland University Hospital in Homburg.
PEPCAD Slide Presentationby Martin Unverdorben, M.D.(Running time: apprx. 2 minutes)Slides are also available for complimentary download(top right of this page)
Dr. Scheller's findings, also reported at TCT, confirmed 12-month PACCOCATH results reported at the American Heart Association meeting last November and published in the New England Journal of Medicine. But Jeffrey Popma, M.D., of Caritas Christi Health Care System and Harvard Medical School, said that both studies used an inaccurate measure for gauging outcome by reporting late lumen loss.
The notion of late lumen loss, he said, was developed as an efficacy measure for stents because the gain in stents was so great as the stent expands and pushes back the vessel wall to expand the lumen, there was also concern that a recoil or natural shrinking effect would follow that great gain. Late lumen loss was developed as a measure of that shrinking.
But balloons, even a drug-coated balloon, do not achieve as great an initial gain as stents, so the loss or recoil would naturally not be as great, Dr. Popma said.
He urged the researchers to recalculate their data using methods specifically developed for assessment of balloon efficacy -- initial gain and loss index -- rather than relying on a late lumen loss, which is applicable only to stents.
That criticism aside, Dr. Popma, who served as commentator during a TCT press briefing where both studies were discussed, said he believed drug-coated ballons would prove to be an effective option for patients who were not good candidates for drug-eluting stents.
"Because the balloon delivers the drug relatively quickly and is then removed, there would be no need for extended dual anti-platelet therapy, so this might be useful for patients who are not good candidates for 12 months of clopidogrel (Plavix) plus aspirin," he said.
PEPCAD II-ISR enrolled 131 patients and Dr. Unverdorben reported six month outcomes for 66 drug-eluting balloon patients and 60 drug-eluting stent patients.
Among the findings:
Late lumen loss was 0.19 mm in the drug-coated balloon arm versus 0.45 mm in the drug-eluting stent arm (P=0.01).
Binary restenosis in segment rate was 3.7% in the balloon arm versus 20.8% in the stent group (P=0.02).
MACE rate was 4.8% in the balloon arm versus 22% in the stent arm (P=0.007).
Target lesion revascularization rate in the balloon arm was 3.2% versus 18.6% in the stent group (P=0.008).
There were no myocardial infarctions and one death in the balloon group versus one MI and one death in the stent group (NS).
Dr. Scheller and colleagues randomized 54 patients with in-stent restenosis to angioplasty with uncoated balloons and 54 to angioplasty with paclitaxel-coated balloons.
The 24-month clinical follow-up found:
The target lesion revascularization rate was 37% for patients treated with uncoated balloons versus 6% for patients treated with drug-coated balloons (P=0.001).
There were five MIs and three deaths in the uncoated balloon group versus one MI and one death in the drug-coated balloon arm (NS).
There were three strokes in the control arm versus two in the paclitaxel-coated balloon arm (NS).
The overall MACE rate was 46% in the control arm versus 11% in the drug-coated balloon group (P=0.001).
The PEPCAD study was funded by B. Braun Melsungen AG, which is developing the SeQuent Please balloon catheter. Dr. Umverdorben reported no financial disclosures. The PACCOCATH trial was funded by Bavaria Medizin Technologie. Dr. Scheller reported being a co-inventor on a patent application for the balloon used in the PACCOCATH trial. Dr. Popma reported financial support from Cordis Corporation, Boston Scientific Corporation, Medtronic, Abbott Vascular, ev3, Gore & Associates, Sanofi-Aventis, The Medicines Company, Bristol-Myers Squibb, and Pfizer. Additional source: Transcatheter Cardiovascular TherapeuticsSource reference: Unverdorben M, et al "The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease" PEPCAD II-ISR Late-Breaking Clinical Trials. Additional source: Transcatheter Cardiovascular TherapeuticsSource reference: Scheller B, et al "PACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis: 2-Year Results" Late Breaking Clinical Trials.
Risk for Stress-Urinary-Incontinence Surgery After Hysterectomy May Be Doubled
Laurie Barclay, MD
October 25, 2007 — Regardless of surgical technique, women who have had a hysterectomy are at a much greater risk for needing stress-urinary-incontinence surgery, according to the results of a nationwide, population-based, cohort study reported in the October 27 issue of The Lancet. An accompanying Comment notes that results from this registry data study differ significantly from those of previous studies, which were smaller and gathered the data differently.
"Hysterectomy for benign indications has been associated with an increased risk for lower-urinary-tract sequela, but results have been inconclusive," write Daniel Altman, MD, from Danderyd University Hospital in Stockholm, Sweden, and colleagues. "We aimed to establish the risk for stress-urinary-incontinence surgery after hysterectomy for benign indications."
Using the Swedish Inpatient Registry from 1973 to 2003, the investigators compared the occurrence of stress-urinary-incontinence surgery in 165,260 women who had undergone hysterectomy (exposed cohort) with that in a control group of 479,506 individuals, matched by year of birth and county of residence, who had not had a hysterectomy (unexposed cohort). Cox's proportional hazards regression was used to determine hazard ratios (HRs).
From 1973 to 2003, the rate of stress-urinary-incontinence surgery per 100,000 person-years was 179 (95% confidence interval [CI], 173 – 186) in the exposed cohort, compared with 76 (95% CI, 73 – 79) in the unexposed cohort. Regardless of surgical technique, risk for stress-urinary-incontinence surgery in the group that underwent hysterectomy was more than double that in the unexposed cohort (HR, 2.4; 95% CI, 2.3 – 2.5).
This risk was slightly different depending on duration of follow-up. The highest overall risk was within 5 years of surgery (HR, 2.7; 95% CI, 2.5 – 2.9), and the lowest risk was observed after an observation period of 10 years or more (HR, 2.1; 95% CI, 1.9 – 2.2).
"Hysterectomy for benign indications, irrespective of surgical technique, increases the risk for subsequent stress-urinary-incontinence surgery," the authors write. "Women should be counselled on associated risks related to hysterectomy, and other treatment options should be considered before surgery.... Our findings have important public-health and clinical applications, in view of the many women undergoing hysterectomy for benign indications."
Reasons proposed by the study authors to explain the increased risk of needing stress-urinary-incontinence surgery include surgical trauma caused when the uterus and cervix are severed from pelvic floor supportive tissues. In addition, hysterectomy could compromise the urethral sphincter mechanism, as well as urethral and bladder neck support.
Study limitations include the inability to account for some potential behavioral and lifestyle factors possibly associated with stress urinary incontinence, such as smoking, strenuous work, and body mass index.
The Swedish Society of Medicine and Eli Lilly, Sweden, supported this study. The authors have disclosed no relevant financial relationships.
In the accompanying Comment, Adam Magos, MD, from Royal Free Hospital, London, United Kingdom, notes that these findings conflict with those of earlier studies, including those from Dr. Altman's group.
"The truth is that there have been many studies that looked at the after-effects of hysterectomy in terms of urinary symptoms and bladder function, but there is no consensus," Dr. Magos writes. "Admittedly, previous studies have tended to be smaller with short follow-ups, but more than one have reported either no detrimental effect of hysterectomy or even benefits.
"It seems likely that a simple hysterectomy does not adversely affect bladder function, at least initially, and indeed pre-existing symptoms may improve," Dr. Magos writes. "If hysterectomy-induced urinary stress incontinence is a reality, it only becomes so several years after the surgery, as already suggested. Or perhaps it has nothing to do with hysterectomy, and women who agree to hysterectomy are just different in ways that we do not yet understand."
Lancet. 2007;370:1494–1499.
Laurie Barclay, MD
October 25, 2007 — Regardless of surgical technique, women who have had a hysterectomy are at a much greater risk for needing stress-urinary-incontinence surgery, according to the results of a nationwide, population-based, cohort study reported in the October 27 issue of The Lancet. An accompanying Comment notes that results from this registry data study differ significantly from those of previous studies, which were smaller and gathered the data differently.
"Hysterectomy for benign indications has been associated with an increased risk for lower-urinary-tract sequela, but results have been inconclusive," write Daniel Altman, MD, from Danderyd University Hospital in Stockholm, Sweden, and colleagues. "We aimed to establish the risk for stress-urinary-incontinence surgery after hysterectomy for benign indications."
Using the Swedish Inpatient Registry from 1973 to 2003, the investigators compared the occurrence of stress-urinary-incontinence surgery in 165,260 women who had undergone hysterectomy (exposed cohort) with that in a control group of 479,506 individuals, matched by year of birth and county of residence, who had not had a hysterectomy (unexposed cohort). Cox's proportional hazards regression was used to determine hazard ratios (HRs).
From 1973 to 2003, the rate of stress-urinary-incontinence surgery per 100,000 person-years was 179 (95% confidence interval [CI], 173 – 186) in the exposed cohort, compared with 76 (95% CI, 73 – 79) in the unexposed cohort. Regardless of surgical technique, risk for stress-urinary-incontinence surgery in the group that underwent hysterectomy was more than double that in the unexposed cohort (HR, 2.4; 95% CI, 2.3 – 2.5).
This risk was slightly different depending on duration of follow-up. The highest overall risk was within 5 years of surgery (HR, 2.7; 95% CI, 2.5 – 2.9), and the lowest risk was observed after an observation period of 10 years or more (HR, 2.1; 95% CI, 1.9 – 2.2).
"Hysterectomy for benign indications, irrespective of surgical technique, increases the risk for subsequent stress-urinary-incontinence surgery," the authors write. "Women should be counselled on associated risks related to hysterectomy, and other treatment options should be considered before surgery.... Our findings have important public-health and clinical applications, in view of the many women undergoing hysterectomy for benign indications."
Reasons proposed by the study authors to explain the increased risk of needing stress-urinary-incontinence surgery include surgical trauma caused when the uterus and cervix are severed from pelvic floor supportive tissues. In addition, hysterectomy could compromise the urethral sphincter mechanism, as well as urethral and bladder neck support.
Study limitations include the inability to account for some potential behavioral and lifestyle factors possibly associated with stress urinary incontinence, such as smoking, strenuous work, and body mass index.
The Swedish Society of Medicine and Eli Lilly, Sweden, supported this study. The authors have disclosed no relevant financial relationships.
In the accompanying Comment, Adam Magos, MD, from Royal Free Hospital, London, United Kingdom, notes that these findings conflict with those of earlier studies, including those from Dr. Altman's group.
"The truth is that there have been many studies that looked at the after-effects of hysterectomy in terms of urinary symptoms and bladder function, but there is no consensus," Dr. Magos writes. "Admittedly, previous studies have tended to be smaller with short follow-ups, but more than one have reported either no detrimental effect of hysterectomy or even benefits.
"It seems likely that a simple hysterectomy does not adversely affect bladder function, at least initially, and indeed pre-existing symptoms may improve," Dr. Magos writes. "If hysterectomy-induced urinary stress incontinence is a reality, it only becomes so several years after the surgery, as already suggested. Or perhaps it has nothing to do with hysterectomy, and women who agree to hysterectomy are just different in ways that we do not yet understand."
Lancet. 2007;370:1494–1499.
New Guidelines Address Treatment of Chemotherapy-Related Anemia
October 26, 2007 — The American Society of Clinical Oncology and the American Society of Hematology have released new clinical practice guidelines on the use of epoetin and darbepoetin. The guidelines, published in the October 22 Online First issue of the Journal of Clinical Oncology, recommend initiating an erythropoiesis-stimulating agent for chemotherapy-related anemia.
Similar evidence-based guidelines on the use of epoetin were first published in 2002. These latest recommendations expand the scope of the guidelines to address the use of darbepoetin and the thromboembolic risk associated with these agents.
"Since the first guidelines were issued, there have been black box warnings issued by the US Food and Drug Administration [FDA],"co-author Alan Lichtin, MD, from the Cleveland Clinic Foundation in Ohio told Medscape Oncology. "We wanted to alert clinicians of these risks and I would say that's the biggest change to the guidelines."
Led by J Douglas Rizzo, MD, from the Medical College of Wisconsin in Milwaukee, the committee reviewed and analyzed data published since 2002 to July 2007. They used MEDLINE and the Cochrane Collaboration Library databases to conduct their searches.
The committee included both epoetin alfa and beta in their analysis, although epoetin beta is not commercially available in the United States. Although there are no published comparative analyses of epoetin alfa and beta, the FDA considers these agents to be part of the same pharmacologic class.
"Biochemical differences between the agents do not translate into differences in their pharmacodynamic properties when they are used at the recommended doses. This is reflected in the product labeling," the committee writes. Therefore, the new recommendations on initiation, dosing, indications, and benefits apply to both epoetin alfa and beta.
Epoetin and Darbepoetin Considered Equivalent in Efficacy and Safety
The committee reports that epoetin and darbepoetin are equivalent in efficacy and safety. They base this on a systematic review comparing outcomes in patients with chemotherapy-induced anemia and on the drugs' identical cancer-related indications, warnings, and cautions in the FDA-approved package inserts.
But when treating chemotherapy-induced anemia, the committee urges clinicians to first consider other correctable causes of anemia before initiating therapy erythropoiesis-stimulating agents.
"At a minimum," they write, "one should take a thorough drug exposure history, carefully review the peripheral blood smear (and, in some cases, the bone marrow), consider iron, folate, and B12 deficiency where indicated, and assess for occult blood loss and renal insufficiency."
The committee also reported on the threshold for initiating erythropoiesis-stimulating agents. If the hemoglobin concentration approaches or falls below 10 g/dL, they recommend increasing the hemoglobin and decreasing transfusions. They note that red-blood-cell transfusion is also an option, depending on the severity of the anemia or clinical circumstances.
For patients with declining hemoglobin, but less severe anemia — those with a concentration of less than 12 g/dL but which has never fallen near 10 g/dL — the committee suggests the decision of whether to use epoetin or darbepoetin immediately or wait until the hemoglobin levels fall closer to 10 g/dL should be determined by clinical circumstances.
The group suggests that conclusive evidence is lacking to suggest that initiating erythropoiesis-stimulating agents at hemoglobin levels greater than 10 g/dL for most clinical circumstances either spares more patients from transfusion or substantially improves quality of life.
They note that starting doses and modifications based on response should follow the product's package insert. Continuing erythropoiesis-stimulating agents after 6 to 8 weeks in the absence of response, assuming appropriate dose increase has been attempted in nonresponders, does not seem to be beneficial, and therapy should be discontinued.
The committee recommends monitoring iron stores and supplementing iron intake for patients receiving treatment. And, erythropoiesis-stimulating agents should be used cautiously with chemotherapy or in clinical states associated with elevated risk for thromboembolic complications. The committee also cautions against using these agents in patients with cancer who are not receiving chemotherapy because recent trials report increased thromboembolic risks and decreased survival in these circumstances.
Agents Boost Thromboembolic Risk
Clinicians should carefully weigh the risks of thromboembolism in patients receiving these agents, the guidelines urge. "Randomized clinical trials and systematic reviews of available randomized clinical trials demonstrate an increased risk of thromboembolism in patients receiving epoetin or darbepoetin."
Specific risk factors for thromboembolism have not been defined in these trials, the committee notes, and clinicians should use caution and clinical judgment when considering use of these agents. Established general risk factors include history of thromboses, surgery, and prolonged periods of immobilization or limited activity. There are no data regarding concomitant use of anticoagulants or aspirin to modulate this risk.
The committee reports there is evidence that supports the use of epoetin or darbepoetin in patients with anemia associated with low-risk myelodysplasia, but no published high-quality studies support its exclusive use in patients with anemic myeloma, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia in the absence of concurrent chemotherapy.
"A number of questions remain," Dr. Lichtin told Medscape Oncology during an interview. "For example, do tumor growth enhancements occur with the use of erythropoiesis-stimulating agents?" This key question, he says, will have to be answered by future studies.
Dr. Lichtin points out problems in previous work, including quality-of-life data suggesting that as hemoglobin levels rose, patients benefited. "We've since observed a downside to elevated hemoglobin levels and I think this may open up a new field of inquiry down the road."
The complete guidelines can be accessed on the Journal of Clinical Oncology Web site at http://www.jco.org.
Several committee members, including Dr. Lichtin, have disclosed various financial relationships with Amgen, a maker of epoetin and darbepoetin, and Johnson and Johnson.
J Clin Oncol. Published online October 22, 2007.
October 26, 2007 — The American Society of Clinical Oncology and the American Society of Hematology have released new clinical practice guidelines on the use of epoetin and darbepoetin. The guidelines, published in the October 22 Online First issue of the Journal of Clinical Oncology, recommend initiating an erythropoiesis-stimulating agent for chemotherapy-related anemia.
Similar evidence-based guidelines on the use of epoetin were first published in 2002. These latest recommendations expand the scope of the guidelines to address the use of darbepoetin and the thromboembolic risk associated with these agents.
"Since the first guidelines were issued, there have been black box warnings issued by the US Food and Drug Administration [FDA],"co-author Alan Lichtin, MD, from the Cleveland Clinic Foundation in Ohio told Medscape Oncology. "We wanted to alert clinicians of these risks and I would say that's the biggest change to the guidelines."
Led by J Douglas Rizzo, MD, from the Medical College of Wisconsin in Milwaukee, the committee reviewed and analyzed data published since 2002 to July 2007. They used MEDLINE and the Cochrane Collaboration Library databases to conduct their searches.
The committee included both epoetin alfa and beta in their analysis, although epoetin beta is not commercially available in the United States. Although there are no published comparative analyses of epoetin alfa and beta, the FDA considers these agents to be part of the same pharmacologic class.
"Biochemical differences between the agents do not translate into differences in their pharmacodynamic properties when they are used at the recommended doses. This is reflected in the product labeling," the committee writes. Therefore, the new recommendations on initiation, dosing, indications, and benefits apply to both epoetin alfa and beta.
Epoetin and Darbepoetin Considered Equivalent in Efficacy and Safety
The committee reports that epoetin and darbepoetin are equivalent in efficacy and safety. They base this on a systematic review comparing outcomes in patients with chemotherapy-induced anemia and on the drugs' identical cancer-related indications, warnings, and cautions in the FDA-approved package inserts.
But when treating chemotherapy-induced anemia, the committee urges clinicians to first consider other correctable causes of anemia before initiating therapy erythropoiesis-stimulating agents.
"At a minimum," they write, "one should take a thorough drug exposure history, carefully review the peripheral blood smear (and, in some cases, the bone marrow), consider iron, folate, and B12 deficiency where indicated, and assess for occult blood loss and renal insufficiency."
The committee also reported on the threshold for initiating erythropoiesis-stimulating agents. If the hemoglobin concentration approaches or falls below 10 g/dL, they recommend increasing the hemoglobin and decreasing transfusions. They note that red-blood-cell transfusion is also an option, depending on the severity of the anemia or clinical circumstances.
For patients with declining hemoglobin, but less severe anemia — those with a concentration of less than 12 g/dL but which has never fallen near 10 g/dL — the committee suggests the decision of whether to use epoetin or darbepoetin immediately or wait until the hemoglobin levels fall closer to 10 g/dL should be determined by clinical circumstances.
The group suggests that conclusive evidence is lacking to suggest that initiating erythropoiesis-stimulating agents at hemoglobin levels greater than 10 g/dL for most clinical circumstances either spares more patients from transfusion or substantially improves quality of life.
They note that starting doses and modifications based on response should follow the product's package insert. Continuing erythropoiesis-stimulating agents after 6 to 8 weeks in the absence of response, assuming appropriate dose increase has been attempted in nonresponders, does not seem to be beneficial, and therapy should be discontinued.
The committee recommends monitoring iron stores and supplementing iron intake for patients receiving treatment. And, erythropoiesis-stimulating agents should be used cautiously with chemotherapy or in clinical states associated with elevated risk for thromboembolic complications. The committee also cautions against using these agents in patients with cancer who are not receiving chemotherapy because recent trials report increased thromboembolic risks and decreased survival in these circumstances.
Agents Boost Thromboembolic Risk
Clinicians should carefully weigh the risks of thromboembolism in patients receiving these agents, the guidelines urge. "Randomized clinical trials and systematic reviews of available randomized clinical trials demonstrate an increased risk of thromboembolism in patients receiving epoetin or darbepoetin."
Specific risk factors for thromboembolism have not been defined in these trials, the committee notes, and clinicians should use caution and clinical judgment when considering use of these agents. Established general risk factors include history of thromboses, surgery, and prolonged periods of immobilization or limited activity. There are no data regarding concomitant use of anticoagulants or aspirin to modulate this risk.
The committee reports there is evidence that supports the use of epoetin or darbepoetin in patients with anemia associated with low-risk myelodysplasia, but no published high-quality studies support its exclusive use in patients with anemic myeloma, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia in the absence of concurrent chemotherapy.
"A number of questions remain," Dr. Lichtin told Medscape Oncology during an interview. "For example, do tumor growth enhancements occur with the use of erythropoiesis-stimulating agents?" This key question, he says, will have to be answered by future studies.
Dr. Lichtin points out problems in previous work, including quality-of-life data suggesting that as hemoglobin levels rose, patients benefited. "We've since observed a downside to elevated hemoglobin levels and I think this may open up a new field of inquiry down the road."
The complete guidelines can be accessed on the Journal of Clinical Oncology Web site at http://www.jco.org.
Several committee members, including Dr. Lichtin, have disclosed various financial relationships with Amgen, a maker of epoetin and darbepoetin, and Johnson and Johnson.
J Clin Oncol. Published online October 22, 2007.
Early Intervention Improves Outcomes in Patients Receiving Long-Term Hemodialysis
October 26, 2007 — A structured program of prompt medical and educational strategies in patients receiving long-term hemodialysis was associated with improved morbidity and mortality lasting up to 1 year, according to the results of a study in the November issue of the Clinical Journal of the American Society of Nephrology.
"Annualized mortality rates of chronic hemodialysis (CHD) patients in their first 90 d of treatment range from 24 to 50%," write Rebecca L. Wingard, from Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues. "Limited studies also show high hospitalization rates. It was hypothesized that a structured quality improvement program (RightStart [RS]), focused on medical needs and patient education and support, would improve outcomes for incident CHD patients."
In this multicenter study, 918 patients receiving incident long-term hemodialysis who were prospectively enrolled in the RS program were compared with a group of 1020 control patients enrolled contemporaneously in non-RS clinics. The 3-month RS intervention consisted of anemia management; focus on dosage of dialysis, nutrition, and dialysis access; and a comprehensive educational program. Patients were observed for up to 12 months for determination of outcomes.
Compared with control patients, patients in the RS program had higher albumin and hematocrit values at 3 months, but the dose of dialysis and permanent access placement were not statistically significantly different between groups. Mental Composite Score for the RS patients improved significantly from baseline. Mean hospitalization days per patient year were lower in RS than in control patients.
At 3, 6, and 12 months, mortality rates for RS vs control patients were 20, 18, and 17 vs 39, 33, and 30 deaths per 100 patient-years, respectively. At the end of 1 year of follow-up, the RS intervention was associated with an approximately 40% reduction in death rates.
Limitations of the study include not being randomized and controlled; unavoidable selection biases, such as exclusion of patients with cognitive impairment in the RS group; missing demographic and clinical data, primarily for the control group; and labor costs of the program, placing an additional financial burden on the participating facilities.
"A targeted program of medical and teaching intervention to meet the specific needs of incident long-term hemodialysis patients results in improved morbidity and mortality," the study authors write. "Notably, the most impressive mortality difference occurs in the first 90 d, and this beneficial effect lasts up to 12 mo, indicating the critical importance of early intensive intervention in this patient population."
Amgen, Inc, the maker of epoetin alfa (Epogen), partly supported this study and employs one of its authors. NovoNordisk, Inc, employs another author.
Clin J Am Soc Nephrol. 2007;2:1170-1175.
October 26, 2007 — A structured program of prompt medical and educational strategies in patients receiving long-term hemodialysis was associated with improved morbidity and mortality lasting up to 1 year, according to the results of a study in the November issue of the Clinical Journal of the American Society of Nephrology.
"Annualized mortality rates of chronic hemodialysis (CHD) patients in their first 90 d of treatment range from 24 to 50%," write Rebecca L. Wingard, from Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues. "Limited studies also show high hospitalization rates. It was hypothesized that a structured quality improvement program (RightStart [RS]), focused on medical needs and patient education and support, would improve outcomes for incident CHD patients."
In this multicenter study, 918 patients receiving incident long-term hemodialysis who were prospectively enrolled in the RS program were compared with a group of 1020 control patients enrolled contemporaneously in non-RS clinics. The 3-month RS intervention consisted of anemia management; focus on dosage of dialysis, nutrition, and dialysis access; and a comprehensive educational program. Patients were observed for up to 12 months for determination of outcomes.
Compared with control patients, patients in the RS program had higher albumin and hematocrit values at 3 months, but the dose of dialysis and permanent access placement were not statistically significantly different between groups. Mental Composite Score for the RS patients improved significantly from baseline. Mean hospitalization days per patient year were lower in RS than in control patients.
At 3, 6, and 12 months, mortality rates for RS vs control patients were 20, 18, and 17 vs 39, 33, and 30 deaths per 100 patient-years, respectively. At the end of 1 year of follow-up, the RS intervention was associated with an approximately 40% reduction in death rates.
Limitations of the study include not being randomized and controlled; unavoidable selection biases, such as exclusion of patients with cognitive impairment in the RS group; missing demographic and clinical data, primarily for the control group; and labor costs of the program, placing an additional financial burden on the participating facilities.
"A targeted program of medical and teaching intervention to meet the specific needs of incident long-term hemodialysis patients results in improved morbidity and mortality," the study authors write. "Notably, the most impressive mortality difference occurs in the first 90 d, and this beneficial effect lasts up to 12 mo, indicating the critical importance of early intensive intervention in this patient population."
Amgen, Inc, the maker of epoetin alfa (Epogen), partly supported this study and employs one of its authors. NovoNordisk, Inc, employs another author.
Clin J Am Soc Nephrol. 2007;2:1170-1175.
New Ventures Help Fight the Frustrations of Fighting Breast Cancer
By MARCI ALBOHER
Rachel Troxell and Kristin Dudley joined an unlikely sorority when they started a company called Lymphedivas to sell fashionable compression sleeves for women suffering from lymphedema — businesses that owe their inspiration to a brush with breast cancer.
Banu Ozden is in that sorority, too. She started a company, Smart Medical Consumer, soon after her second cancer diagnosis in 2005, because she said she wanted to help others avoid the frustration she experienced in managing the costs and paperwork associated with her illness.
While no organization tracks the number of businesses in this niche, experts who follow women-owned businesses say the numbers are huge. Nell Merlino, president of Count Me In for Women’s Economic Independence, a provider of microloans to women-owned businesses, said that 6 of the 100 businesses selected for her company’s “Make Mine a Million” program were founded by breast cancer survivors.
Because survival rates have increased sharply in recent years, there are now 2.3 million breast cancer survivors in the country, according to Susan G. Komen for the Cure, one of the largest breast cancer research and advocacy organizations. Many of those survivors say they are committed to doing something to ease the ordeal of others with the disease or to solve a particular problem that they encountered in their own treatment.
“Breast cancer survivors are the largest group of cancer survivors in the country,” said Katrina McGhee, vice president for marketing at Komen for the Cure. “And the disease gets to the heart of womanhood. Will they still be attractive? Will they still be the same? There is often a very visual representation of your battle, particularly if you have to go through a mastectomy, which is very different than something on the inside of your body, which can be a more private battle. It is simply life-altering.”
Ms. Troxell, 37, learned she had breast cancer three years ago. After going through surgery, chemotherapy and radiation, she said the hardest part was learning that she had lymphedema, a condition that affects a sizable number of breast cancer survivors and causes their limbs to swell with fluid. “With the cancer, there was a clear path to follow, and I knew there was an end to it,” she said. “With lymphedema, you are stuck with it, and it affects the quality of your life.”
Ms. Troxell said her treatment for lymphedema required her to wear a compression sleeve constantly, leading to questions from everyone she encountered. Ms. Troxell, a videographer and graphic designer, said she became consumed with finding an alternative to the drab, unsightly and uncomfortable sleeve.
“I called some companies that made the ugly garment, asking if there were other options, and they all said no,” she said. “It is just middle-aged white guys making them, and they aren’t the customer.” Her obsession led her to Ms. Dudley, then a 22-year-old fashion student at Drexel University in Philadelphia. The two started brainstorming about designing a more fashionable and comfortable compression sleeve.
Ms. Dudley immediately warmed to the idea because her grandmother had lymphedema and refused to wear her own compression sleeves.
They are now partners in Lymphedivas, which was officially born in 2006 after they won third place in a business plan contest sponsored by Drexel University.
Ms. Ozden, a computer scientist whose cancer was diagnosed in 2001, said that from the time she started dealing with the disease, she wanted to design a system that would make it easier for patients to keep track of their medical costs and also help them find errors in billing and reimbursement records.
In 2005, when teaching computer science at the University of Southern California, she was told that she again had cancer and that this time the disease had spread. Hearing the word “metastatic” was her biggest fear. “When it happened, it was incredibly emotional,” she said. “Western medicine puts statistics on you and from that moment, it is considered not curable. It was the worst time of my life.”
She took a leave of absence from her job and moved to New York so that she could be treated at Memorial Sloan-Kettering Cancer Center, and within a month of her diagnosis, she said she was feeling well enough to start making plans again.
Once again in the morass of medical bills, she knew she wanted to proceed with her company. She started Smart Medical Consumer with her own funds and investments from friends and family members. She works out of her apartment in New York City and has eight employees, some of whom live in Turkey, where Ms. Ozden was born and the source of some of her company’s financing. To provide income until Smart Medical Consumer turns a profit, Ms. Ozden does consulting work in computer science and technology.
Leigh Hurst, 37, said she never intended to start a business when her cancer was diagnosed in 2004. She just wanted to spread the word among her friends and other young women that they needed to be serious about breast self-examination. “Basically, I was telling everyone I met to ‘feel their boobies,’ and when I walked with a group of friends in the Avon breast cancer walk in New York, I set up a one-page Web site, put ‘Feel Your Boobies’ on our T-shirts and printed an extra hundred to sell,” she said. Ms. Hurst sold all the T-shirts within minutes and donated the proceeds to Komen for the Cure.
Her group was filmed by the “Today” show and when she returned home to Harrisburg, Pa., she started filling orders that were coming in through the Web site. She also started getting requests to speak at colleges. After much deliberation, she concluded that her company should be a nonprofit and that T-shirts were merely a vehicle to raise awareness. She put her parents to work in her house, filling orders and handling customer service, and quit her job in online education, replacing it with freelance work.
Kim Carlos’s story has a similar ring. During her treatment for breast cancer, Ms. Carlos, 36, had a weekly lunch at Nordstrom department store in Kansas City, Mo., with three other relatively young women with breast cancer. Those lunches formed the basis of a book, “Nordie’s at Noon,” which the women published themselves. Their grass-roots marketing was so successful that the book was bought and redistributed by Da Capo Press.
Ms. Carlos’s activism brought her so many requests for speaking and advocacy work that she decided to leave her position at a law firm in Kansas City to dedicate herself to motivational speaking and issues-oriented public relations.
As the primary breadwinner in her family, Ms. Carlos said she realized that the move was risky, but she thought that she could always go back to practicing law. “We didn’t go through this to change one life; we did this to change thousands,” she said. Her husband left the business world several years ago to become a firefighter, a job that might not pay well, but does provide the family with health care coverage.
Optimistic as these women are, they are also realists. Ms. Ozden is prepared for investors to ask questions about her future “Our plan is that before 2010, the company can be independent from me,” she said. “I am hoping to be around at least until then.” Ms. Troxell is undergoing treatment for a recurrence and this time the cancer is metastatic. And since “Nordies at Noon” was published, two of Ms. Carlos’s co-authors have died.
By MARCI ALBOHER
Rachel Troxell and Kristin Dudley joined an unlikely sorority when they started a company called Lymphedivas to sell fashionable compression sleeves for women suffering from lymphedema — businesses that owe their inspiration to a brush with breast cancer.
Banu Ozden is in that sorority, too. She started a company, Smart Medical Consumer, soon after her second cancer diagnosis in 2005, because she said she wanted to help others avoid the frustration she experienced in managing the costs and paperwork associated with her illness.
While no organization tracks the number of businesses in this niche, experts who follow women-owned businesses say the numbers are huge. Nell Merlino, president of Count Me In for Women’s Economic Independence, a provider of microloans to women-owned businesses, said that 6 of the 100 businesses selected for her company’s “Make Mine a Million” program were founded by breast cancer survivors.
Because survival rates have increased sharply in recent years, there are now 2.3 million breast cancer survivors in the country, according to Susan G. Komen for the Cure, one of the largest breast cancer research and advocacy organizations. Many of those survivors say they are committed to doing something to ease the ordeal of others with the disease or to solve a particular problem that they encountered in their own treatment.
“Breast cancer survivors are the largest group of cancer survivors in the country,” said Katrina McGhee, vice president for marketing at Komen for the Cure. “And the disease gets to the heart of womanhood. Will they still be attractive? Will they still be the same? There is often a very visual representation of your battle, particularly if you have to go through a mastectomy, which is very different than something on the inside of your body, which can be a more private battle. It is simply life-altering.”
Ms. Troxell, 37, learned she had breast cancer three years ago. After going through surgery, chemotherapy and radiation, she said the hardest part was learning that she had lymphedema, a condition that affects a sizable number of breast cancer survivors and causes their limbs to swell with fluid. “With the cancer, there was a clear path to follow, and I knew there was an end to it,” she said. “With lymphedema, you are stuck with it, and it affects the quality of your life.”
Ms. Troxell said her treatment for lymphedema required her to wear a compression sleeve constantly, leading to questions from everyone she encountered. Ms. Troxell, a videographer and graphic designer, said she became consumed with finding an alternative to the drab, unsightly and uncomfortable sleeve.
“I called some companies that made the ugly garment, asking if there were other options, and they all said no,” she said. “It is just middle-aged white guys making them, and they aren’t the customer.” Her obsession led her to Ms. Dudley, then a 22-year-old fashion student at Drexel University in Philadelphia. The two started brainstorming about designing a more fashionable and comfortable compression sleeve.
Ms. Dudley immediately warmed to the idea because her grandmother had lymphedema and refused to wear her own compression sleeves.
They are now partners in Lymphedivas, which was officially born in 2006 after they won third place in a business plan contest sponsored by Drexel University.
Ms. Ozden, a computer scientist whose cancer was diagnosed in 2001, said that from the time she started dealing with the disease, she wanted to design a system that would make it easier for patients to keep track of their medical costs and also help them find errors in billing and reimbursement records.
In 2005, when teaching computer science at the University of Southern California, she was told that she again had cancer and that this time the disease had spread. Hearing the word “metastatic” was her biggest fear. “When it happened, it was incredibly emotional,” she said. “Western medicine puts statistics on you and from that moment, it is considered not curable. It was the worst time of my life.”
She took a leave of absence from her job and moved to New York so that she could be treated at Memorial Sloan-Kettering Cancer Center, and within a month of her diagnosis, she said she was feeling well enough to start making plans again.
Once again in the morass of medical bills, she knew she wanted to proceed with her company. She started Smart Medical Consumer with her own funds and investments from friends and family members. She works out of her apartment in New York City and has eight employees, some of whom live in Turkey, where Ms. Ozden was born and the source of some of her company’s financing. To provide income until Smart Medical Consumer turns a profit, Ms. Ozden does consulting work in computer science and technology.
Leigh Hurst, 37, said she never intended to start a business when her cancer was diagnosed in 2004. She just wanted to spread the word among her friends and other young women that they needed to be serious about breast self-examination. “Basically, I was telling everyone I met to ‘feel their boobies,’ and when I walked with a group of friends in the Avon breast cancer walk in New York, I set up a one-page Web site, put ‘Feel Your Boobies’ on our T-shirts and printed an extra hundred to sell,” she said. Ms. Hurst sold all the T-shirts within minutes and donated the proceeds to Komen for the Cure.
Her group was filmed by the “Today” show and when she returned home to Harrisburg, Pa., she started filling orders that were coming in through the Web site. She also started getting requests to speak at colleges. After much deliberation, she concluded that her company should be a nonprofit and that T-shirts were merely a vehicle to raise awareness. She put her parents to work in her house, filling orders and handling customer service, and quit her job in online education, replacing it with freelance work.
Kim Carlos’s story has a similar ring. During her treatment for breast cancer, Ms. Carlos, 36, had a weekly lunch at Nordstrom department store in Kansas City, Mo., with three other relatively young women with breast cancer. Those lunches formed the basis of a book, “Nordie’s at Noon,” which the women published themselves. Their grass-roots marketing was so successful that the book was bought and redistributed by Da Capo Press.
Ms. Carlos’s activism brought her so many requests for speaking and advocacy work that she decided to leave her position at a law firm in Kansas City to dedicate herself to motivational speaking and issues-oriented public relations.
As the primary breadwinner in her family, Ms. Carlos said she realized that the move was risky, but she thought that she could always go back to practicing law. “We didn’t go through this to change one life; we did this to change thousands,” she said. Her husband left the business world several years ago to become a firefighter, a job that might not pay well, but does provide the family with health care coverage.
Optimistic as these women are, they are also realists. Ms. Ozden is prepared for investors to ask questions about her future “Our plan is that before 2010, the company can be independent from me,” she said. “I am hoping to be around at least until then.” Ms. Troxell is undergoing treatment for a recurrence and this time the cancer is metastatic. And since “Nordies at Noon” was published, two of Ms. Carlos’s co-authors have died.
Staph screening said may wipe out germ
By LINDSEY TANNER, AP Medical WriterFri Oct 26, 11:51 AM ET
Testing all new hospital patients for a dangerous staph "superbug" could help wipe out a germ that likely kills more Americans than AIDS, consumer advocates say and early evidence suggests.
Yet few U.S. hospitals do it, and many fight efforts to require it. Jeanine Thomas, who nearly died from the drug-resistant staph bug, says the reason is simple: "Doctors don't want to be told what to do."
The Chicago suburbanite's personal crusade led Illinois this year to become the first state to order testing of all high-risk hospital patients and isolation of those who carry the staph germ called MRSA.
Powerful doctor groups fought against it. The testing and isolation of patients would be too costly, they said. Many other germs plague hospitals that also require attention. Experts said a more proven approach would focus on better hand washing by hospital staff — a simple measure tough to enforce.
Yet, Thomas prevailed. Similar measures passed this year in Pennsylvania and New Jersey. And Thomas' national crusade to make hospitals test for MRSA and report their infection rates gained steam last week after a Virginia teenager's death from the germ and a government report estimated it causes dangerous infections that sicken more than 90,000 Americans each year and kill nearly 19,000.
Suddenly the little-known germ with the cumbersome name, methicillin-resistant Staphylococcus aureus, is getting lots of attention.
People in health care settings, like hospitals and nursing homes, are most at risk for MRSA infections. Doctors and nurses who treat staph-infected patients and then don't carefully wash up can spread the germ to other patients. Germ-contaminated medical devices used on people having dialysis or medical procedures also can spread staph. Older patients and blacks are most at risk, according to the recent report by government researchers.
MRSA, pronounced Muhr-suh, has been around for decades and in recent years has spread to schools, prisons and crowded public housing projects. Even healthy people can carry it on their skin. It may look like a pimple or spider bite that doesn't heal, but it can turn deadly if it enters the bloodstream or morphs into a flesh-eating wound.
Yet, many infection control experts oppose required testing for it in hospitals.
Many note that MRSA is just one of dozens of risky germs that often infect people in hospitals — particularly those with weakened immune systems or open wounds.
But Lisa McGiffert doesn't buy it. The director of the Consumers Union's campaign to stop hospital infections calls that "an argument of distraction."
"Certainly there are other superbugs and they should be tackling those, too," said McGiffert. "To eradicate hospital-acquired infections is going to take a comprehensive effort" that should include testing hospital patients, she said.
About 1.7 million Americans each year develop infections from various germs while hospitalized and almost 100,000 of them die, according to the U.S. Centers for Disease Control and Prevention.
MRSA accounts for only about 10 percent of these infections. Other worrisome bugs include C-difficile (an intestinal infection), vancomycin-resistant Enterococcus (linked with intestinal, skin and blood infections), and drug-resistant Acinetobacter (which can cause pneumonia, skin and blood infections); none of them accounts for more than 10 percent of hospital infections.
MRSA infections have hogged attention, partly because they're on the rise. And, acknowledges the CDC's Dr. John Jernigan, "MRSA likely accounts for a disproportionate amount of illness and death" because of its strength and resistance to mainline antibiotics.
CDC recommendations for fighting drug-resistant bugs list MRSA testing as an option. However, the agency says it's unclear whether that works better than other measures. Those include judicious use of antibiotics, hand washing, and wearing gloves, gowns and other protective gear.
"We don't think (testing is) a silver bullet to that problem," Jernigan said.
The Joint Commission, an independent, nonprofit group that sets standards for the nation's hospitals, doesn't have specific rules on how to prevent MRSA.
The commission's Dr. Robert Wise said the organization wants to see evidence that MRSA testing and other measures work. He said the commission hopes to have an answer early next year and then will then decide whether to adopt new standards.
Perhaps the commission will review an experiment done in Pittsburgh. There, the Veterans Affairs hospital tested new patients for staph, using a nose swab. They isolated those who had the germ, and annual infection rates fell from about 60 to 18 cases, said Dr. Rajiv Jain.
The staph bug used to cause "occasional" deaths, but no patient has died since 2005 when testing of all patients began, said Jain, who is with the VA's MRSA prevention program.
In May, the VA began putting a $28 million testing system in place for all 155 hospitals. But it costs about $32,000 to treat one hospitalized MRSA patient, so "if you reduce infections by 50 percent, you more than recuperate the cost," Jain said.
Denmark, Iceland, Norway, and the Netherlands have reduced their MRSA rates and all test high-risk patients. In the Netherlands, that means testing foreign patients.
Opponents of mandatory testing point out that these small countries all had low rates of the germ to begin with. Hospitals in larger, more diverse nations like Britain, for example, have long had problems with MRSA.
And testing may not make sense for hospitals that treat few high-risk patients or where other bugs are more prevalent, opponents say.
"The best approach is not to have state legislators dictating how hospitals go about fighting infections, said Dr. Don Goldmann, of the Institute of Healthcare Improvement, a nonprofit advocacy group.
At the University of Chicago Medical Center, doctors have been focusing on C-difficile bacteria, which can cause severe intestinal illness.
With Illinois' new law requiring MRSA testing, "We're having to shift gears and haven't been able to devote what we'd hoped on these other pressing problems," said Dr. Stephen Weber, the hospital epidemiologist.
At Chicago's Rush University Medical Center, lab supplies alone for the testing will likely cost about $80,000, said Stacy Pur, Rush's chief nurse epidemiologist for infection control.
"It's very labor-intensive and we would really much rather focus our efforts on infection control" measures proven to work, including better hand washing by hospital staff, she said.
But Thomas, the MRSA patient-turned-advocate, argues: "You're never going to control this with hand hygiene, because you're never going to get 100 percent compliance."
Thomas had never heard of MRSA until she slipped on ice seven years ago and broke her left ankle. That landed her in a Chicago hospital, where she believes she got the infection.
Two days after being sent home, she developed throbbing pain in her left leg. She went to the emergency room, where doctors removed her splint and found the ankle hugely swollen, black and draining pus. She was admitted and given antibiotics, but within a week the infection spread inside her body; her lungs, kidneys and other vital organs shut down.
Hospitalized for three weeks and bedridden for six months, she recovered but her ankle joint was destroyed. She formed a support group and began lobbying for the new law.
Now Thomas is working with advocates in several other states.
"We have a wave happening," she said.
And if Illinois hospitals don't comply, she may push to enact testing of all — not just high-risk — hospital patients.
That has been done since 2005 at three Chicago area hospitals in the Evanston Northwestern Healthcare system. There, the MRSA infection rate has dropped 60 percent, said the system's Dr. Lance Peterson.
And at the VA hospital in Pittsburgh, Jain reported an added bonus. The rates for other hospital-acquired infections also fell after MRSA testing began.
Why? The testing may have caused hospital workers to pay more attention to hand washing and other prevention efforts, he said.
___
Medical Writer Maria Cheng in London contributed to this report.
____
CDC: http://www.cdc.gov
MRSA support group: http://www.mrsa-survivors
By LINDSEY TANNER, AP Medical WriterFri Oct 26, 11:51 AM ET
Testing all new hospital patients for a dangerous staph "superbug" could help wipe out a germ that likely kills more Americans than AIDS, consumer advocates say and early evidence suggests.
Yet few U.S. hospitals do it, and many fight efforts to require it. Jeanine Thomas, who nearly died from the drug-resistant staph bug, says the reason is simple: "Doctors don't want to be told what to do."
The Chicago suburbanite's personal crusade led Illinois this year to become the first state to order testing of all high-risk hospital patients and isolation of those who carry the staph germ called MRSA.
Powerful doctor groups fought against it. The testing and isolation of patients would be too costly, they said. Many other germs plague hospitals that also require attention. Experts said a more proven approach would focus on better hand washing by hospital staff — a simple measure tough to enforce.
Yet, Thomas prevailed. Similar measures passed this year in Pennsylvania and New Jersey. And Thomas' national crusade to make hospitals test for MRSA and report their infection rates gained steam last week after a Virginia teenager's death from the germ and a government report estimated it causes dangerous infections that sicken more than 90,000 Americans each year and kill nearly 19,000.
Suddenly the little-known germ with the cumbersome name, methicillin-resistant Staphylococcus aureus, is getting lots of attention.
People in health care settings, like hospitals and nursing homes, are most at risk for MRSA infections. Doctors and nurses who treat staph-infected patients and then don't carefully wash up can spread the germ to other patients. Germ-contaminated medical devices used on people having dialysis or medical procedures also can spread staph. Older patients and blacks are most at risk, according to the recent report by government researchers.
MRSA, pronounced Muhr-suh, has been around for decades and in recent years has spread to schools, prisons and crowded public housing projects. Even healthy people can carry it on their skin. It may look like a pimple or spider bite that doesn't heal, but it can turn deadly if it enters the bloodstream or morphs into a flesh-eating wound.
Yet, many infection control experts oppose required testing for it in hospitals.
Many note that MRSA is just one of dozens of risky germs that often infect people in hospitals — particularly those with weakened immune systems or open wounds.
But Lisa McGiffert doesn't buy it. The director of the Consumers Union's campaign to stop hospital infections calls that "an argument of distraction."
"Certainly there are other superbugs and they should be tackling those, too," said McGiffert. "To eradicate hospital-acquired infections is going to take a comprehensive effort" that should include testing hospital patients, she said.
About 1.7 million Americans each year develop infections from various germs while hospitalized and almost 100,000 of them die, according to the U.S. Centers for Disease Control and Prevention.
MRSA accounts for only about 10 percent of these infections. Other worrisome bugs include C-difficile (an intestinal infection), vancomycin-resistant Enterococcus (linked with intestinal, skin and blood infections), and drug-resistant Acinetobacter (which can cause pneumonia, skin and blood infections); none of them accounts for more than 10 percent of hospital infections.
MRSA infections have hogged attention, partly because they're on the rise. And, acknowledges the CDC's Dr. John Jernigan, "MRSA likely accounts for a disproportionate amount of illness and death" because of its strength and resistance to mainline antibiotics.
CDC recommendations for fighting drug-resistant bugs list MRSA testing as an option. However, the agency says it's unclear whether that works better than other measures. Those include judicious use of antibiotics, hand washing, and wearing gloves, gowns and other protective gear.
"We don't think (testing is) a silver bullet to that problem," Jernigan said.
The Joint Commission, an independent, nonprofit group that sets standards for the nation's hospitals, doesn't have specific rules on how to prevent MRSA.
The commission's Dr. Robert Wise said the organization wants to see evidence that MRSA testing and other measures work. He said the commission hopes to have an answer early next year and then will then decide whether to adopt new standards.
Perhaps the commission will review an experiment done in Pittsburgh. There, the Veterans Affairs hospital tested new patients for staph, using a nose swab. They isolated those who had the germ, and annual infection rates fell from about 60 to 18 cases, said Dr. Rajiv Jain.
The staph bug used to cause "occasional" deaths, but no patient has died since 2005 when testing of all patients began, said Jain, who is with the VA's MRSA prevention program.
In May, the VA began putting a $28 million testing system in place for all 155 hospitals. But it costs about $32,000 to treat one hospitalized MRSA patient, so "if you reduce infections by 50 percent, you more than recuperate the cost," Jain said.
Denmark, Iceland, Norway, and the Netherlands have reduced their MRSA rates and all test high-risk patients. In the Netherlands, that means testing foreign patients.
Opponents of mandatory testing point out that these small countries all had low rates of the germ to begin with. Hospitals in larger, more diverse nations like Britain, for example, have long had problems with MRSA.
And testing may not make sense for hospitals that treat few high-risk patients or where other bugs are more prevalent, opponents say.
"The best approach is not to have state legislators dictating how hospitals go about fighting infections, said Dr. Don Goldmann, of the Institute of Healthcare Improvement, a nonprofit advocacy group.
At the University of Chicago Medical Center, doctors have been focusing on C-difficile bacteria, which can cause severe intestinal illness.
With Illinois' new law requiring MRSA testing, "We're having to shift gears and haven't been able to devote what we'd hoped on these other pressing problems," said Dr. Stephen Weber, the hospital epidemiologist.
At Chicago's Rush University Medical Center, lab supplies alone for the testing will likely cost about $80,000, said Stacy Pur, Rush's chief nurse epidemiologist for infection control.
"It's very labor-intensive and we would really much rather focus our efforts on infection control" measures proven to work, including better hand washing by hospital staff, she said.
But Thomas, the MRSA patient-turned-advocate, argues: "You're never going to control this with hand hygiene, because you're never going to get 100 percent compliance."
Thomas had never heard of MRSA until she slipped on ice seven years ago and broke her left ankle. That landed her in a Chicago hospital, where she believes she got the infection.
Two days after being sent home, she developed throbbing pain in her left leg. She went to the emergency room, where doctors removed her splint and found the ankle hugely swollen, black and draining pus. She was admitted and given antibiotics, but within a week the infection spread inside her body; her lungs, kidneys and other vital organs shut down.
Hospitalized for three weeks and bedridden for six months, she recovered but her ankle joint was destroyed. She formed a support group and began lobbying for the new law.
Now Thomas is working with advocates in several other states.
"We have a wave happening," she said.
And if Illinois hospitals don't comply, she may push to enact testing of all — not just high-risk — hospital patients.
That has been done since 2005 at three Chicago area hospitals in the Evanston Northwestern Healthcare system. There, the MRSA infection rate has dropped 60 percent, said the system's Dr. Lance Peterson.
And at the VA hospital in Pittsburgh, Jain reported an added bonus. The rates for other hospital-acquired infections also fell after MRSA testing began.
Why? The testing may have caused hospital workers to pay more attention to hand washing and other prevention efforts, he said.
___
Medical Writer Maria Cheng in London contributed to this report.
____
CDC: http://www.cdc.gov
MRSA support group: http://www.mrsa-survivors
Boiled nuts help protect against illness
Fri Oct 26, 3:45 PM ET
For lovers of boiled peanuts, there's some good news from the health front. A new study by a group of Huntsville researchers found that boiled peanuts bring out up to four times more chemicals that help protect against disease than raw, dry or oil-roasted nuts.
Lloyd Walker, chair of Alabama A&M University's Department of Food and Animal Sciences who co-authored the study, said these phytochemicals have antioxidant qualities that protect cells against the risk of degenerative diseases, including cancers, diabetes and heart disease.
"Boiling is a better method of preparing peanuts in order to preserve these phytochemicals," Walker said.
The study will appear in Wednesday's edition of the American Chemical Society's Journal of Agricultural and Food Chemistry. The other co-authors in the study are A&M researchers Yvonne Chukwumah and Martha Verghese, as well as University of Alabama in Huntsville researcher Bernhard Vogler.
Walker said peanuts and other plants use phytochemicals for things such as helping avoid disease and insect attacks.
"These things are not nutrients; at the same time they have health benefits to humans," he told The Birmingham News. "The trick is to keep those health benefits, not to process them out of the foods."
According to Walker, water and heat penetrate the nuts, releasing beneficial chemicals to a certain point. Overcooking the nuts destroys the useful elements.
Alabama is third in the nation in the amount of peanuts produced with a crop valued at more than $67 million last year.
Fri Oct 26, 3:45 PM ET
For lovers of boiled peanuts, there's some good news from the health front. A new study by a group of Huntsville researchers found that boiled peanuts bring out up to four times more chemicals that help protect against disease than raw, dry or oil-roasted nuts.
Lloyd Walker, chair of Alabama A&M University's Department of Food and Animal Sciences who co-authored the study, said these phytochemicals have antioxidant qualities that protect cells against the risk of degenerative diseases, including cancers, diabetes and heart disease.
"Boiling is a better method of preparing peanuts in order to preserve these phytochemicals," Walker said.
The study will appear in Wednesday's edition of the American Chemical Society's Journal of Agricultural and Food Chemistry. The other co-authors in the study are A&M researchers Yvonne Chukwumah and Martha Verghese, as well as University of Alabama in Huntsville researcher Bernhard Vogler.
Walker said peanuts and other plants use phytochemicals for things such as helping avoid disease and insect attacks.
"These things are not nutrients; at the same time they have health benefits to humans," he told The Birmingham News. "The trick is to keep those health benefits, not to process them out of the foods."
According to Walker, water and heat penetrate the nuts, releasing beneficial chemicals to a certain point. Overcooking the nuts destroys the useful elements.
Alabama is third in the nation in the amount of peanuts produced with a crop valued at more than $67 million last year.
Friday, October 26, 2007
Errors by Resident Physicians Often Result of Inadequate Supervision
HOUSTON, Oct. 25 -- Medical errors by resident physicians in U.S. hospitals stem from lack of judgment and technical competence but also from inadequate supervision by senior physicians, a study of malpractice claims found.
Among 240 claims in which trainees (mainly residents) were judged to have played an important role, errors of judgment was the most frequent contributing factor, found in 72% of cases, Hardeep Singh, M.D., M.P.H., of Baylor College of Medicine here, and colleagues, reported in the Oct. 22 issue of Archives of Internal Medicine.
Breakdowns in teamwork was a close second at 70% and lack of technical competence was found in 58% of cases, the researchers said.
Trainees are inexperienced, often tired, and occasionally unsupervised, and they tend to work at medical centers treating the sickest patients, the researchers noted. Yet there has been limited information about the types and causes of trainees' errors.
To remedy this, they studied closed claims from five malpractice insurance companies in four regions of the U.S.
The claims were closed between 1984 and 2004, and the errors occurred between 1979 and 2001.
Specialist physicians reviewed a random sample of the claims and determined whether injuries had occurred, and if so, whether they were caused by a medical error.
Of 889 cases (claims with both error and injury) identified, 240 (27%) involved trainees whose role was judged to be at least moderately important.
Nearly 80% of the cases involved trainee physicians in obstetrics-gynecology, general surgery, adult primary care, orthopedic surgery, and pediatrics. Three out of 10 were in obstetrics-gynecology.
The researchers also compared the characteristics of cases in which trainees were involved with cases that did not involve trainees and probed trainee errors attributed to teamwork problems and lack of technical competence or knowledge.
Among the 240 cases, there were 173 that exhibited errors in judgment (72%), 167 that showed teamwork breakdowns (70%), and 139 in which lack of technical competence played a role (58%).
As examples of lack of technical competence, the investigators noted a case in which a surgical resident missed the diagnosis of a bile leak after abdominal surgery and another in which an obstetric resident misdiagnosed a breech presentation.
Lack of supervision and hand-off problems were the most common types of teamwork snafus, and both were disproportionately more common among errors that involved trainees than among those that did not (respectively, 54% versus 7% and 20% versus 12%).
In 82% of the cases involving lack of supervision, the failure lay with attending physicians. In 12% of the cases, both senior residents and attending physicians failed to provide residents with proper supervision, the researchers said.
The most common task during which failure of technical competence occurred were diagnostic decision-making and monitoring the patient or situation. Trainee errors appeared
more complex than nontrainee errors (mean of 3.8 contributing factors versus 2.5 [P<0.001]).
Secondary tasks, such as monitoring, were also associated with cases of technical competence problems. For example, one resident's failure to diagnose a high-risk pregnancy was accompanied by inadequate fetal monitoring.
Not only were hand-off problems a factor, but so were poor teamwork and transfer problems between trainees and attending physicians, nurses, pharmacists, and laboratories.
The methodological approach in this study had a number of advantages over those previously used, the researchers said. However, there were limitations, they noted, including the fact that litigated claims are just the "tip of the iceberg" of all errors.
Also, certain contributing factors may not have been detectable through claims reviews. Thus, fatigue and workload were particularly likely to have been undocumented, unless they were part of the plaintiff's allegation.
Finally, the reviewers' judgments of the appropriateness of care may have been biased by the knowledge of the litigation outcome, they said.
The characteristics detected in malpractice claims data suggest special vulnerabilities around teamwork, levels of supervision, and diagnostic decision-making, the investigators said.
Their findings should help leaders of residency programs and the Accreditation Council for Graduate Medical Education orient training interventions toward these problem areas and also stimulate further research into why and how trainee errors occur, they concluded.
In an accompanying editorial, Robert A. Phillips, M.D., Ph.D., of UMass Memorial Medical Center in Worcester, and Julia D. Andrieni, M.D., proposed a new collaborative, payer-driven model for inpatient care. That model would include:
Medical care teams consisting of house officers, hospitalists, and nursing staff, with hospitalists as the central glue.
Coordinated work hours and shifts, so that patients have the greatest chance of being cared for by the same team.
Coordinated work and discharge rounds.
Monitoring outcomes with measures from the Joint Commission on Accreditation of Healthcare Organizations and developing new patient safety measures.
Payer reimbursement tied to this new structure of medical teams and documentation. Hospitals that attain this goal should receive a higher compensation rate from payers.
The Centers for Medicare and Medicaid Services, insurance companies, and federally funded graduate medical education would probably support such a model, Dr. Phillips and Dr. Andrieni said. Initially, however, hospital administrators, program directors, hospitalists, and nurses might view this as too onerous, they noted.
In the end, they wrote, to address the issues raised by this study, "We really do not have a choice but to implement a new model of coordinated care."
HOUSTON, Oct. 25 -- Medical errors by resident physicians in U.S. hospitals stem from lack of judgment and technical competence but also from inadequate supervision by senior physicians, a study of malpractice claims found.
Among 240 claims in which trainees (mainly residents) were judged to have played an important role, errors of judgment was the most frequent contributing factor, found in 72% of cases, Hardeep Singh, M.D., M.P.H., of Baylor College of Medicine here, and colleagues, reported in the Oct. 22 issue of Archives of Internal Medicine.
Breakdowns in teamwork was a close second at 70% and lack of technical competence was found in 58% of cases, the researchers said.
Trainees are inexperienced, often tired, and occasionally unsupervised, and they tend to work at medical centers treating the sickest patients, the researchers noted. Yet there has been limited information about the types and causes of trainees' errors.
To remedy this, they studied closed claims from five malpractice insurance companies in four regions of the U.S.
The claims were closed between 1984 and 2004, and the errors occurred between 1979 and 2001.
Specialist physicians reviewed a random sample of the claims and determined whether injuries had occurred, and if so, whether they were caused by a medical error.
Of 889 cases (claims with both error and injury) identified, 240 (27%) involved trainees whose role was judged to be at least moderately important.
Nearly 80% of the cases involved trainee physicians in obstetrics-gynecology, general surgery, adult primary care, orthopedic surgery, and pediatrics. Three out of 10 were in obstetrics-gynecology.
The researchers also compared the characteristics of cases in which trainees were involved with cases that did not involve trainees and probed trainee errors attributed to teamwork problems and lack of technical competence or knowledge.
Among the 240 cases, there were 173 that exhibited errors in judgment (72%), 167 that showed teamwork breakdowns (70%), and 139 in which lack of technical competence played a role (58%).
As examples of lack of technical competence, the investigators noted a case in which a surgical resident missed the diagnosis of a bile leak after abdominal surgery and another in which an obstetric resident misdiagnosed a breech presentation.
Lack of supervision and hand-off problems were the most common types of teamwork snafus, and both were disproportionately more common among errors that involved trainees than among those that did not (respectively, 54% versus 7% and 20% versus 12%).
In 82% of the cases involving lack of supervision, the failure lay with attending physicians. In 12% of the cases, both senior residents and attending physicians failed to provide residents with proper supervision, the researchers said.
The most common task during which failure of technical competence occurred were diagnostic decision-making and monitoring the patient or situation. Trainee errors appeared
more complex than nontrainee errors (mean of 3.8 contributing factors versus 2.5 [P<0.001]).
Secondary tasks, such as monitoring, were also associated with cases of technical competence problems. For example, one resident's failure to diagnose a high-risk pregnancy was accompanied by inadequate fetal monitoring.
Not only were hand-off problems a factor, but so were poor teamwork and transfer problems between trainees and attending physicians, nurses, pharmacists, and laboratories.
The methodological approach in this study had a number of advantages over those previously used, the researchers said. However, there were limitations, they noted, including the fact that litigated claims are just the "tip of the iceberg" of all errors.
Also, certain contributing factors may not have been detectable through claims reviews. Thus, fatigue and workload were particularly likely to have been undocumented, unless they were part of the plaintiff's allegation.
Finally, the reviewers' judgments of the appropriateness of care may have been biased by the knowledge of the litigation outcome, they said.
The characteristics detected in malpractice claims data suggest special vulnerabilities around teamwork, levels of supervision, and diagnostic decision-making, the investigators said.
Their findings should help leaders of residency programs and the Accreditation Council for Graduate Medical Education orient training interventions toward these problem areas and also stimulate further research into why and how trainee errors occur, they concluded.
In an accompanying editorial, Robert A. Phillips, M.D., Ph.D., of UMass Memorial Medical Center in Worcester, and Julia D. Andrieni, M.D., proposed a new collaborative, payer-driven model for inpatient care. That model would include:
Medical care teams consisting of house officers, hospitalists, and nursing staff, with hospitalists as the central glue.
Coordinated work hours and shifts, so that patients have the greatest chance of being cared for by the same team.
Coordinated work and discharge rounds.
Monitoring outcomes with measures from the Joint Commission on Accreditation of Healthcare Organizations and developing new patient safety measures.
Payer reimbursement tied to this new structure of medical teams and documentation. Hospitals that attain this goal should receive a higher compensation rate from payers.
The Centers for Medicare and Medicaid Services, insurance companies, and federally funded graduate medical education would probably support such a model, Dr. Phillips and Dr. Andrieni said. Initially, however, hospital administrators, program directors, hospitalists, and nurses might view this as too onerous, they noted.
In the end, they wrote, to address the issues raised by this study, "We really do not have a choice but to implement a new model of coordinated care."
Older Physicians Unhappy and Looking to Bail Out of Medicine
IRVING, Tex., Oct. 25 -- Half of physicians from ages 50 to 65 are frustrated with their practices and plan to sharply cut back or abandon patient care within the next three years, according to a survey.
Fifty-two percent of these older physicians said they find medicine has become less satisfying over the past five years, according to a survey by Merritt Hawkins & Associates, a national physician search and consulting firm.
Only 10% of nearly 1,200 responding physicians said the practice of medicine is "very satisfying," down from 20% in earlier surveys.
What's more, 44% of the surveyed physicians said they wouldn't choose medicine as a career if they were starting out today and 57% would discourage their children or other young people from doing so.
These doctors don't intend to remain unhappy for much longer, though. Almost half of survey respondents said they will retire over the next three years, seek nonclinical jobs, work part time, close their practices to new patients (18% have already done so), or significantly reduce the number of patients they see.
If that trend continues, patient access to health care could be severely jeopardized. "Almost half the physicians in the United States are 50 years old or older," said Mark Smith, executive vice-president of Merritt Hawkins. "An exodus of older doctors from medicine would be a disaster for patient care in this country."
The Council on Graduate Medical Education (COGME), a panel of health care authorities, has endorsed a study predicting a shortage of 96,000 physicians by the year 2020. If only 20% of physicians in the 50 to 65 age bracket opt for retirement or nonclinical roles in the next three years, nearly 60,000 physicians would be removed from the clinical workforce, the survey noted.
"The tens of millions of patient encounters these physicians handle would have to be absorbed by younger physicians or by those older physicians remaining in clinical practice."
Why do physicians claim to be so disgruntled? Reimbursement issues were cited by 33% of doctors as their greatest single source of professional frustration, followed by malpractice worries (18%) and long hours (15%).
That represents a significant shift. In the 2004 Merritt Hawkins survey, malpractice worries were the main source of frustration (28%). Reimbursement issues were cited by only 16%.
"When Baby Boom doctors entered medicine, they had control over how they practiced and the fees they charged," noted Smith. "But the rules changed on them in midstream and now many are looking for a ticket out."
These older physicians don't have much regard for the work ethic of their younger counterparts. More than two-thirds of respondents said physicians being trained today are less dedicated and hard-working than they are.
Recently trained physicians may put a higher premium on "quality of life" issues than senior physicians often do. "We find that younger physicians today generally prefer and expect fixed hours, a good call schedule with reliable coverage, and regular vacation time," the survey report noted.
A much higher percentage of young physicians today are female than was the case in the past, and female physicians work 18% fewer hours per week than male physicians, according to the AMA. For these reasons, it may take two younger physicians to replace a more senior doctor.
On a more positive note, six in 10 older physicians said patient relationships are their single greatest source of professional satisfaction.
Also, 48% of physicians indicated that the quality of health care in the United States has generally improved over the last 20 years, compared with 33% who indicated it has generally declined.
So, the survey authors concluded, although the practice of medicine may have become problematic for many older physicians, patient care has generally improved.
The survey was mailed to 10,000 physicians across the nation and 1,175 participated, a 12% response rate. Surgical and internal medicine subspecialists comprised 47% of respondents, followed by primary care physicians (36%) and hospital-based doctors (17%).
IRVING, Tex., Oct. 25 -- Half of physicians from ages 50 to 65 are frustrated with their practices and plan to sharply cut back or abandon patient care within the next three years, according to a survey.
Fifty-two percent of these older physicians said they find medicine has become less satisfying over the past five years, according to a survey by Merritt Hawkins & Associates, a national physician search and consulting firm.
Only 10% of nearly 1,200 responding physicians said the practice of medicine is "very satisfying," down from 20% in earlier surveys.
What's more, 44% of the surveyed physicians said they wouldn't choose medicine as a career if they were starting out today and 57% would discourage their children or other young people from doing so.
These doctors don't intend to remain unhappy for much longer, though. Almost half of survey respondents said they will retire over the next three years, seek nonclinical jobs, work part time, close their practices to new patients (18% have already done so), or significantly reduce the number of patients they see.
If that trend continues, patient access to health care could be severely jeopardized. "Almost half the physicians in the United States are 50 years old or older," said Mark Smith, executive vice-president of Merritt Hawkins. "An exodus of older doctors from medicine would be a disaster for patient care in this country."
The Council on Graduate Medical Education (COGME), a panel of health care authorities, has endorsed a study predicting a shortage of 96,000 physicians by the year 2020. If only 20% of physicians in the 50 to 65 age bracket opt for retirement or nonclinical roles in the next three years, nearly 60,000 physicians would be removed from the clinical workforce, the survey noted.
"The tens of millions of patient encounters these physicians handle would have to be absorbed by younger physicians or by those older physicians remaining in clinical practice."
Why do physicians claim to be so disgruntled? Reimbursement issues were cited by 33% of doctors as their greatest single source of professional frustration, followed by malpractice worries (18%) and long hours (15%).
That represents a significant shift. In the 2004 Merritt Hawkins survey, malpractice worries were the main source of frustration (28%). Reimbursement issues were cited by only 16%.
"When Baby Boom doctors entered medicine, they had control over how they practiced and the fees they charged," noted Smith. "But the rules changed on them in midstream and now many are looking for a ticket out."
These older physicians don't have much regard for the work ethic of their younger counterparts. More than two-thirds of respondents said physicians being trained today are less dedicated and hard-working than they are.
Recently trained physicians may put a higher premium on "quality of life" issues than senior physicians often do. "We find that younger physicians today generally prefer and expect fixed hours, a good call schedule with reliable coverage, and regular vacation time," the survey report noted.
A much higher percentage of young physicians today are female than was the case in the past, and female physicians work 18% fewer hours per week than male physicians, according to the AMA. For these reasons, it may take two younger physicians to replace a more senior doctor.
On a more positive note, six in 10 older physicians said patient relationships are their single greatest source of professional satisfaction.
Also, 48% of physicians indicated that the quality of health care in the United States has generally improved over the last 20 years, compared with 33% who indicated it has generally declined.
So, the survey authors concluded, although the practice of medicine may have become problematic for many older physicians, patient care has generally improved.
The survey was mailed to 10,000 physicians across the nation and 1,175 participated, a 12% response rate. Surgical and internal medicine subspecialists comprised 47% of respondents, followed by primary care physicians (36%) and hospital-based doctors (17%).
Given Risk-Benefit Data, Women Age 70 Opt for Routine Mammography
SYDNEY, Australia, Oct. 25 -- Seventy-year-old women resoundingly endorsed yearly mammography, rejecting the minuses that were pointed out of them, found investigators here.
The women chose to continue having an annual mammogram after studying a decision booklet citing mammography pros and cons for women their age. Alexandra Barratt, M.B.B.S., Ph.D., of the University of Sydney, and colleagues, reported in the Oct. 22 issue of the Archives of Internal Medicine.
Although better informed than a control group and able to make an informed choice, 95% of the women remained positive about continued screening, they found.
But just as many women in the control group, who received only standard information, also chose to continue screening, the researchers wrote.
Screening is generally recommended for women ages 50 to 69, but for women 70 years or older, in whom harm starts to outweigh benefit, recommendations are less clear.
For example, the U.S. Preventive Services Task Force notes that a mortality benefit from screening is still likely for women older than 70, if life expectancy is not compromised by comorbid disease.
On the other hand, there are concerns about detecting and treating cancers in older women, which, without screening, would not have affected patients' health or life expectancy.
Evaluating the risk and benefits of further screening may be difficult for individual women, and there are no evaluated decision support tools to assist them, the researchers said.
The researchers assessed 734 women in a population-based, randomized controlled trial in New South Wales, Australia. The trial was conduced from August 2005 to June 2006.
Women age 70 who had regularly participated in mammography screening were eligible for the trial. Women in the intervention group (367) received the decision aid, while those in the control group (367) received standard information available from the screening program.
The decision aid, a booklet with information, charts, and worksheets provided a clear, detailed presentation of the risks, benefits, options, and the chances of the possible outcomes for each choice.
For example, according to one of the scenarios, screening 1,000 women 70 or older over the next 10 years would result in:
Two fewer women dying of breast cancer as a result of screening.
15 more women diagnosed with breast cancer, but some of these cancers would never have been found without screening.
135 women having extra tests after an abnormal mammogram, although they do not have breast cancer. However, they may worry.
824 women being correctly reassured that they do not have breast cancer.
Women who received the decision aid were better informed than the control group. The mean increase in knowledge out of a score of 10, was 2.62 for the intervention group versus 0.68 for the control group (P<0.001), the researchers reported.
Furthermore, a significantly greater percentage made what they called an informed choice (73.5% versus 48.8%; P<0.001).
The decision aid did not increase anxiety and slightly reduced decisional conflict, they said.
Women in the intervention group were less likely to be undecided about screening (odds ratio, 0.32, 95% confidence interval, 0.17-0.63, P<0.001).
Among those women who had made a decision about screening, the decision aid did not alter the odds of intending to stop screening (OR, 1.28, CI 0.63-2.61, P=0.02), the researchers reported.
Of the women randomized to the decision aid, 94.7% remained positive about continuing screening, the researchers reported. In the control group, 95.9% were also positive about screening (P=0.50).
One month after the intervention, there was no difference in the percentage of women who had participated in screening between the two groups. Actually, at this time few women had actually had a mammogram, but most indicated that they were in the process of making appointments for screening.
In an accompanying editorial, Louise C. Walter, M.D., of the VA Medical Center and the University of California San Francisco, and Carmen L. Lewis, M.D., of the University of North Carolina, wrote, "Is this high enthusiasm for screening among women in this age group appropriate?"
Currently many patients, even elderly women in poor health, do not make informed decisions about screening because they downplay the potential harm of screening.
Decision aids are a promising tool, they said, although many questions remain unanswered about how to present the information and the integration of decision aids into medical practice.
Further evaluation of strategies to best address the information needs of the diverse elderly population is needed to ensure that older adults are not left behind when it comes to maximizing informed decision making," Drs. Walter and Lewis wrote.
No financial conflicts were reported by the study authors. The study was supported by a grant from the National Health and Medical Research Council of Australia. The sponsor had no role in the design, analysis, or interpretation of the study, or the preparation, review, or approval of the manuscript.
The editorial writers reported no financial conflicts. Their work was supported by a grant from the National Health and Medical Research Council of Australia. The views expressed in this article did not necessarily reflect the position of the Department of Veterans Affairs. Primary source: Archives of Internal MedicineSource reference: Mathieu E, et al "Informed Choice in Mammography Screening: A Randomized Trial of a Decision Aid for 70-Year-Old Women" Arch Intern Med 2007; 167: 2039-2046. Additional source: Archives of Internal MedicineSource reference: Walter LC, Lewis CL, "Maximizing Informed Cancer Screening Decisions" Arch Intern Med 2007; 167: 2027-2028.
SYDNEY, Australia, Oct. 25 -- Seventy-year-old women resoundingly endorsed yearly mammography, rejecting the minuses that were pointed out of them, found investigators here.
The women chose to continue having an annual mammogram after studying a decision booklet citing mammography pros and cons for women their age. Alexandra Barratt, M.B.B.S., Ph.D., of the University of Sydney, and colleagues, reported in the Oct. 22 issue of the Archives of Internal Medicine.
Although better informed than a control group and able to make an informed choice, 95% of the women remained positive about continued screening, they found.
But just as many women in the control group, who received only standard information, also chose to continue screening, the researchers wrote.
Screening is generally recommended for women ages 50 to 69, but for women 70 years or older, in whom harm starts to outweigh benefit, recommendations are less clear.
For example, the U.S. Preventive Services Task Force notes that a mortality benefit from screening is still likely for women older than 70, if life expectancy is not compromised by comorbid disease.
On the other hand, there are concerns about detecting and treating cancers in older women, which, without screening, would not have affected patients' health or life expectancy.
Evaluating the risk and benefits of further screening may be difficult for individual women, and there are no evaluated decision support tools to assist them, the researchers said.
The researchers assessed 734 women in a population-based, randomized controlled trial in New South Wales, Australia. The trial was conduced from August 2005 to June 2006.
Women age 70 who had regularly participated in mammography screening were eligible for the trial. Women in the intervention group (367) received the decision aid, while those in the control group (367) received standard information available from the screening program.
The decision aid, a booklet with information, charts, and worksheets provided a clear, detailed presentation of the risks, benefits, options, and the chances of the possible outcomes for each choice.
For example, according to one of the scenarios, screening 1,000 women 70 or older over the next 10 years would result in:
Two fewer women dying of breast cancer as a result of screening.
15 more women diagnosed with breast cancer, but some of these cancers would never have been found without screening.
135 women having extra tests after an abnormal mammogram, although they do not have breast cancer. However, they may worry.
824 women being correctly reassured that they do not have breast cancer.
Women who received the decision aid were better informed than the control group. The mean increase in knowledge out of a score of 10, was 2.62 for the intervention group versus 0.68 for the control group (P<0.001), the researchers reported.
Furthermore, a significantly greater percentage made what they called an informed choice (73.5% versus 48.8%; P<0.001).
The decision aid did not increase anxiety and slightly reduced decisional conflict, they said.
Women in the intervention group were less likely to be undecided about screening (odds ratio, 0.32, 95% confidence interval, 0.17-0.63, P<0.001).
Among those women who had made a decision about screening, the decision aid did not alter the odds of intending to stop screening (OR, 1.28, CI 0.63-2.61, P=0.02), the researchers reported.
Of the women randomized to the decision aid, 94.7% remained positive about continuing screening, the researchers reported. In the control group, 95.9% were also positive about screening (P=0.50).
One month after the intervention, there was no difference in the percentage of women who had participated in screening between the two groups. Actually, at this time few women had actually had a mammogram, but most indicated that they were in the process of making appointments for screening.
In an accompanying editorial, Louise C. Walter, M.D., of the VA Medical Center and the University of California San Francisco, and Carmen L. Lewis, M.D., of the University of North Carolina, wrote, "Is this high enthusiasm for screening among women in this age group appropriate?"
Currently many patients, even elderly women in poor health, do not make informed decisions about screening because they downplay the potential harm of screening.
Decision aids are a promising tool, they said, although many questions remain unanswered about how to present the information and the integration of decision aids into medical practice.
Further evaluation of strategies to best address the information needs of the diverse elderly population is needed to ensure that older adults are not left behind when it comes to maximizing informed decision making," Drs. Walter and Lewis wrote.
No financial conflicts were reported by the study authors. The study was supported by a grant from the National Health and Medical Research Council of Australia. The sponsor had no role in the design, analysis, or interpretation of the study, or the preparation, review, or approval of the manuscript.
The editorial writers reported no financial conflicts. Their work was supported by a grant from the National Health and Medical Research Council of Australia. The views expressed in this article did not necessarily reflect the position of the Department of Veterans Affairs. Primary source: Archives of Internal MedicineSource reference: Mathieu E, et al "Informed Choice in Mammography Screening: A Randomized Trial of a Decision Aid for 70-Year-Old Women" Arch Intern Med 2007; 167: 2039-2046. Additional source: Archives of Internal MedicineSource reference: Walter LC, Lewis CL, "Maximizing Informed Cancer Screening Decisions" Arch Intern Med 2007; 167: 2027-2028.
Provigil Linked to Risk for Serious Skin Rash, Psychiatric Symptoms
Yael Waknine
October 25, 2007 — Information regarding cases of serious rash, hypersensitivity reactions, and psychiatric symptoms has been added to the safety labeling for modafinil tablets (Provigil, Cephalon, Inc), the US Food and Drug Administration warned healthcare professionals yesterday.
Rare cases of life-threatening rash, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms have been reported in adults and children during worldwide postmarketing use of modafinil.
The incidence of SJS and TEN exceeds the background rate (1 – 2 cases/million-person years) despite likely underreporting. Cases of angioedema and sometimes fatal multiorgan hypersensitivity reactions have also been reported.
Patients should be instructed to immediately discontinue therapy and contact their healthcare professional if a rash or other hypersensitivity reaction occurs, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
Psychiatric adverse events have also been reported in connection with modafinil, including anxiety, mania, hallucinations, and suicidal ideation. Caution is advised when treating patients with a history of psychosis, depression, or mania; discontinuation of therapy should be considered in those who develop psychiatric symptoms.
Modafinil is indicated to improve wakefulness in adult patients with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. It is not approved for use in children.
Healthcare professionals are encouraged to contact the company at 1-800-896-5855 regarding modafinil-related cases of rash or other hypersensitivity reactions.
Adverse events related to modafinil should also be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Yael Waknine
October 25, 2007 — Information regarding cases of serious rash, hypersensitivity reactions, and psychiatric symptoms has been added to the safety labeling for modafinil tablets (Provigil, Cephalon, Inc), the US Food and Drug Administration warned healthcare professionals yesterday.
Rare cases of life-threatening rash, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms have been reported in adults and children during worldwide postmarketing use of modafinil.
The incidence of SJS and TEN exceeds the background rate (1 – 2 cases/million-person years) despite likely underreporting. Cases of angioedema and sometimes fatal multiorgan hypersensitivity reactions have also been reported.
Patients should be instructed to immediately discontinue therapy and contact their healthcare professional if a rash or other hypersensitivity reaction occurs, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
Psychiatric adverse events have also been reported in connection with modafinil, including anxiety, mania, hallucinations, and suicidal ideation. Caution is advised when treating patients with a history of psychosis, depression, or mania; discontinuation of therapy should be considered in those who develop psychiatric symptoms.
Modafinil is indicated to improve wakefulness in adult patients with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. It is not approved for use in children.
Healthcare professionals are encouraged to contact the company at 1-800-896-5855 regarding modafinil-related cases of rash or other hypersensitivity reactions.
Adverse events related to modafinil should also be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Sleep Deprivation Leads to Emotional Instability Even in Healthy Subjects
October 25, 2007 — New research sheds important light on the link between sleep deprivation and psychiatric illness. A study appearing in the October 22 issue of Current Biology shows that parts of the brain governing emotional responses were much more active in people who had skipped a night's sleep and were exposed to disturbing images than in a control group of individuals exposed to the same pictures.
"The study provides a new foundation of evidence on which to consider more seriously that sleep may play a significant role in regulating our emotional stability," said Mathew Walker, director of the University of California, Berkeley's Sleep and Neuroimaging Laboratory, and senior author of the study.
"This is the first set of experiments that demonstrate that even healthy people's brains mimic certain pathological psychiatric patterns when deprived of sleep."
Sleep-Deprived Brains More Reactive
Dr. Walker and his colleagues enrolled 26 healthy undergraduates aged 18 to 30 years and separated them into 2 groups with equal numbers of males and females. One group stayed awake for about 35 hours (1 day, 1 night, and the following day) while the control group stayed awake on both days but slept normally at home during the night. At the end of the second day, both groups were shown 100 images that ranged from the emotionally neutral to the highly disturbing (ie, pictures of mutilated bodies and children with tumors) while undergoing brain scanning with functional magnetic resonance imaging (fMRI).
When the researchers quantified and compared brain activity in the amygdala, the area of the brain that oversees emotional reactions, they found significant differences in the brains of the sleep-deprived group when they were exposed to the negative pictures. "Rather than the brain being dulled or suppressed in its activity when you're sleep deprived, we found that the deep emotional centers of the brain were approximately 60% more reactive when you're sleep deprived," Dr. Walker told Medscape Psychiatry.
The amygdala serves to alert the body to protect itself in times of danger, according to background information supplied by UC Berkeley. In the setting of sleep deprivation, the amygdala goes into overdrive in response to emotional images — for example, shutting down the prefrontal cortex, the area of the brain that governs logical reasoning. Instead, it activates the locus coeruleus, which releases noradrenaline to ward off imminent threats to survival, a potentially volatile mix, they note.
Chicken or Egg?
The study provides useful insights into the relationship between sleep disruption and mood and other psychiatric disorders, said Dr. Walker. Almost all psychiatric conditions have some sleep abnormalities, he explains. "In fact, it's difficult to find a psychiatric disorder, particularly ones involving emotion, that don't have some kind of sleep impairment." The issue that has remained unresolved, however, is the exact relationship between sleep and psychiatric illness: does a psychiatric disorder cause sleep impairment, or does a sleep problem cause a psychiatric disorder?
In the past, most people assumed that sleep disorders were an offshoot of psychiatric problems, but this study casts doubt on that assumption, he said. It shows that emotional reactions of healthy but sleep-deprived people are similar to those seen in psychiatric disorders. "The patterns of brain activity that you see in those healthy people who have had a lack of sleep are not dissimilar to the patterns of brain activity that you see in people suffering things like depression and [posttraumatic stress disorder]," said Dr. Walker.
Although the difference in emotional brain responses between the 2 groups in the study averaged 60%, it ranged from as low as 40% to as high as 80%. One of the next steps for researchers, Dr. Walker said, is to determine whether women are more likely to have the greater emotional brain reaction when they're sleep deprived. "That's something we will be looking into," said Dr. Walker.
Researchers already believe that there's a closer relationship between sleep disturbance and depression among women than among men. If that is the case, "it suggests that what we should find in our results is that the females should be responding more abnormality than the males, but we don't know that yet."
What About the Real World?
Another question that remains unanswered is whether the relationship between sleep deprivation and psychiatric disorders exists not just inside the controlled environment of a sleep laboratory but also "in the real world," where people may not be totally sleep deprived but may regularly get only a few hours of sleep a night. "We don't know yet whether there would be the same amplified emotional brain response if we were to put people on a 5-hour sleep schedule for a week, so they accumulate approximately the same amount of sleep deprivation, and then perform the same experiment," he said.
Another element of the real world is shift work. There is anecdotal evidence that people who work overnight shifts might be more emotionally unstable than other workers, said Dr. Walker. "In terms of their mental health, they just don't seem to be functioning very well. I think [with this study], we're starting to see some of the reasons [for this]."
The authors report no relevant financial relationships. The research was supported in part by grants from the National Institutes of Health and the American Academy of Sleep Medicine.
Current Biology 2007;17:95-97.
October 25, 2007 — New research sheds important light on the link between sleep deprivation and psychiatric illness. A study appearing in the October 22 issue of Current Biology shows that parts of the brain governing emotional responses were much more active in people who had skipped a night's sleep and were exposed to disturbing images than in a control group of individuals exposed to the same pictures.
"The study provides a new foundation of evidence on which to consider more seriously that sleep may play a significant role in regulating our emotional stability," said Mathew Walker, director of the University of California, Berkeley's Sleep and Neuroimaging Laboratory, and senior author of the study.
"This is the first set of experiments that demonstrate that even healthy people's brains mimic certain pathological psychiatric patterns when deprived of sleep."
Sleep-Deprived Brains More Reactive
Dr. Walker and his colleagues enrolled 26 healthy undergraduates aged 18 to 30 years and separated them into 2 groups with equal numbers of males and females. One group stayed awake for about 35 hours (1 day, 1 night, and the following day) while the control group stayed awake on both days but slept normally at home during the night. At the end of the second day, both groups were shown 100 images that ranged from the emotionally neutral to the highly disturbing (ie, pictures of mutilated bodies and children with tumors) while undergoing brain scanning with functional magnetic resonance imaging (fMRI).
When the researchers quantified and compared brain activity in the amygdala, the area of the brain that oversees emotional reactions, they found significant differences in the brains of the sleep-deprived group when they were exposed to the negative pictures. "Rather than the brain being dulled or suppressed in its activity when you're sleep deprived, we found that the deep emotional centers of the brain were approximately 60% more reactive when you're sleep deprived," Dr. Walker told Medscape Psychiatry.
The amygdala serves to alert the body to protect itself in times of danger, according to background information supplied by UC Berkeley. In the setting of sleep deprivation, the amygdala goes into overdrive in response to emotional images — for example, shutting down the prefrontal cortex, the area of the brain that governs logical reasoning. Instead, it activates the locus coeruleus, which releases noradrenaline to ward off imminent threats to survival, a potentially volatile mix, they note.
Chicken or Egg?
The study provides useful insights into the relationship between sleep disruption and mood and other psychiatric disorders, said Dr. Walker. Almost all psychiatric conditions have some sleep abnormalities, he explains. "In fact, it's difficult to find a psychiatric disorder, particularly ones involving emotion, that don't have some kind of sleep impairment." The issue that has remained unresolved, however, is the exact relationship between sleep and psychiatric illness: does a psychiatric disorder cause sleep impairment, or does a sleep problem cause a psychiatric disorder?
In the past, most people assumed that sleep disorders were an offshoot of psychiatric problems, but this study casts doubt on that assumption, he said. It shows that emotional reactions of healthy but sleep-deprived people are similar to those seen in psychiatric disorders. "The patterns of brain activity that you see in those healthy people who have had a lack of sleep are not dissimilar to the patterns of brain activity that you see in people suffering things like depression and [posttraumatic stress disorder]," said Dr. Walker.
Although the difference in emotional brain responses between the 2 groups in the study averaged 60%, it ranged from as low as 40% to as high as 80%. One of the next steps for researchers, Dr. Walker said, is to determine whether women are more likely to have the greater emotional brain reaction when they're sleep deprived. "That's something we will be looking into," said Dr. Walker.
Researchers already believe that there's a closer relationship between sleep disturbance and depression among women than among men. If that is the case, "it suggests that what we should find in our results is that the females should be responding more abnormality than the males, but we don't know that yet."
What About the Real World?
Another question that remains unanswered is whether the relationship between sleep deprivation and psychiatric disorders exists not just inside the controlled environment of a sleep laboratory but also "in the real world," where people may not be totally sleep deprived but may regularly get only a few hours of sleep a night. "We don't know yet whether there would be the same amplified emotional brain response if we were to put people on a 5-hour sleep schedule for a week, so they accumulate approximately the same amount of sleep deprivation, and then perform the same experiment," he said.
Another element of the real world is shift work. There is anecdotal evidence that people who work overnight shifts might be more emotionally unstable than other workers, said Dr. Walker. "In terms of their mental health, they just don't seem to be functioning very well. I think [with this study], we're starting to see some of the reasons [for this]."
The authors report no relevant financial relationships. The research was supported in part by grants from the National Institutes of Health and the American Academy of Sleep Medicine.
Current Biology 2007;17:95-97.
Nocturnal and Sleep Heart Rates Linked to All-Cause Mortality
October 25, 2007 — Nocturnal heart rate measures from awake levels as well as heart rate during sleep are associated with all-cause mortality, according to the results of a study reported in the October 22 issue of the Archives of Internal Medicine.
"Although it has been somewhat overlooked, resting heart rate is an established predictor of cardiovascular and noncardiovascular outcome," write Iddo Z. Ben-Dov, MD, from the Hadassah–Hebrew University Medical Center in Jerusalem, Israel, and colleagues. "We assessed the determinants and mortality associations of heart rate measured during ambulatory blood pressure monitoring (ABPM) to evaluate its informativeness during activity and sleep."
The study cohort consisted of 3957 patients who were referred for ABPM from 1991 to 2005. Mean age was 55 ± 16 years; 58% of patients were treated for hypertension. Nondipping of heart rate was defined as (awake value − sleep value)/awake value < 0.1. Covariate associations with ambulatory heart rate indices were determined from linear and logistic regression models, and all-cause mortality was evaluated with Cox proportional hazards modeling.
Positive correlates of awake and sleep heart rates were female sex, body mass index, and treated diabetes. In contrast, age and treated hypertension were inversely associated with awake and sleep heart rates. All of these variables were associated with a lower magnitude of sleep-related dipping of heart rate.
Multivariate-adjusted odds ratios (ORs) for nondipping of heart rate during sleep were 1.02 (95% confidence interval [CI], 1.02 - 1.03) per year of age, 1.05 (95% CI, 1.03 - 1.06) for body mass index, 1.39 (95% CI, 1.20 - 1.60) for female sex, 1.30 (95% CI, 1.12 - 1.51) for daytime naps, 2.19 (95% CI, 1.87 - 2.57) for treated hypertension, and 1.38 (95% CI, 1.09 - 1.76) for treated diabetes.
Mortality analysis based on deciles of the different heart rate variables showed that only dip in heart rate had a robust linear relationship, with a hazard ratio (HR) of 2.67 (95% CI, 1.31 - 5.47) for the lowest vs the highest decile.
"In clinical practice, ambulatory heart rate adds prognostic information beyond that of other ABPM predictors," the study authors write. "Heart rate measures during sleep, and in particular the absence of dipping of heart rate to sleep levels, were independently associated with all-cause mortality.... We suggest that a sympathetic overactive state may be better represented by an elevated sleeping heart rate than by the clinic heart rate (owing in part to poor standardization of the latter and the white coat effect) or by the awake heart rate (owing to its dependence on physical activity and fitness as well as sympathetic drive)."
This study was supported in part by a research prize from the Israel Society of Hypertension. The study authors have disclosed no relevant financial relationships.
Arch Intern Med. 2007;167:2116-2121.
October 25, 2007 — Nocturnal heart rate measures from awake levels as well as heart rate during sleep are associated with all-cause mortality, according to the results of a study reported in the October 22 issue of the Archives of Internal Medicine.
"Although it has been somewhat overlooked, resting heart rate is an established predictor of cardiovascular and noncardiovascular outcome," write Iddo Z. Ben-Dov, MD, from the Hadassah–Hebrew University Medical Center in Jerusalem, Israel, and colleagues. "We assessed the determinants and mortality associations of heart rate measured during ambulatory blood pressure monitoring (ABPM) to evaluate its informativeness during activity and sleep."
The study cohort consisted of 3957 patients who were referred for ABPM from 1991 to 2005. Mean age was 55 ± 16 years; 58% of patients were treated for hypertension. Nondipping of heart rate was defined as (awake value − sleep value)/awake value < 0.1. Covariate associations with ambulatory heart rate indices were determined from linear and logistic regression models, and all-cause mortality was evaluated with Cox proportional hazards modeling.
Positive correlates of awake and sleep heart rates were female sex, body mass index, and treated diabetes. In contrast, age and treated hypertension were inversely associated with awake and sleep heart rates. All of these variables were associated with a lower magnitude of sleep-related dipping of heart rate.
Multivariate-adjusted odds ratios (ORs) for nondipping of heart rate during sleep were 1.02 (95% confidence interval [CI], 1.02 - 1.03) per year of age, 1.05 (95% CI, 1.03 - 1.06) for body mass index, 1.39 (95% CI, 1.20 - 1.60) for female sex, 1.30 (95% CI, 1.12 - 1.51) for daytime naps, 2.19 (95% CI, 1.87 - 2.57) for treated hypertension, and 1.38 (95% CI, 1.09 - 1.76) for treated diabetes.
Mortality analysis based on deciles of the different heart rate variables showed that only dip in heart rate had a robust linear relationship, with a hazard ratio (HR) of 2.67 (95% CI, 1.31 - 5.47) for the lowest vs the highest decile.
"In clinical practice, ambulatory heart rate adds prognostic information beyond that of other ABPM predictors," the study authors write. "Heart rate measures during sleep, and in particular the absence of dipping of heart rate to sleep levels, were independently associated with all-cause mortality.... We suggest that a sympathetic overactive state may be better represented by an elevated sleeping heart rate than by the clinic heart rate (owing in part to poor standardization of the latter and the white coat effect) or by the awake heart rate (owing to its dependence on physical activity and fitness as well as sympathetic drive)."
This study was supported in part by a research prize from the Israel Society of Hypertension. The study authors have disclosed no relevant financial relationships.
Arch Intern Med. 2007;167:2116-2121.
Chlorhexidine-Based Solutions May Be Preferred to Prevent Catheter-Related Infection
October 25, 2007 — Chlorhexidine-based solutions should be considered as a replacement for povidone-iodine formulations, including those that are alcohol based, in efforts to prevent central venous catheter–related infection, according to the results of a study reported in the October 22 issue of the Archives of Internal Medicine.
"Although chlorhexidine-based solutions and alcohol-based povidone-iodine have been shown to be more efficient than aqueous povidone-iodine for skin disinfection at catheter insertion sites, their abilities to reduce catheter-related infection have never been compared," write Olivier Mimoz, MD, PhD, from Centre Hospitalier et Universitaire de Poitiers in France, and colleagues. "Catheter-related bloodstream infections have been reported to occur in 3% to 8% of catheters inserted and are the predominant cause of nosocomial bacteremia in intensive care units (ICUs), with 80,000 cases annually at a cost of $300 million to $2.3 billion."
In this study, 538 consecutively scheduled central venous catheters inserted into jugular or subclavian veins were randomized to be disinfected with 5% povidone-iodine in 70% ethanol or with a combination of 0.25% chlorhexidine gluconate, 0.025% benzalkonium chloride, and 4% benzylic alcohol. These solutions were used before catheter insertion for skin disinfection with 2 consecutive 30-second applications, allowing the skin to dry in between, as well as for single applications during subsequent dressing changes, which were performed every 72 hours or sooner if the dressing became soiled or wet.
Culture results were evaluable in 481 (89.4%) of catheters studied. Compared with use of povidone-iodine, the chlorhexidine-based solution was associated with a 50% reduction in the incidence of catheter colonization (11.6% vs 22.2%; P =.002; incidence density, 9.7 vs 18.3 per 1000 catheter-days). There was also a statistically nonsignificant trend toward lower rates of catheter-related bloodstream infection (1.7% vs 4.2%; P =. 09; incidence density, 1.4 vs 3.4 per 1000 catheter-days).
Risk factors that were independently associated with catheter colonization were catheter insertion into the jugular vein (adjusted relative risk [RR], 2.01; 95% confidence interval [CI], 1.24 - 3.24) and use of povidone-iodine (adjusted RR, 1.87; 95% CI, 1.18 - 2.96).
"Chlorhexidine-based solutions should be considered as a replacement for povidone-iodine (including alcohol-based) formulations in efforts to prevent catheter-related infection," the study authors write.
Limitations of the study include lack of blinding, treatment groups not equally distributed with regard to sex, and insufficient power to demonstrate a significant reduction of catheter-related bloodstream infection.
"Our results demonstrate that the use of a chlorhexidine-based solution rather than povidone-iodine is likely to result in decreased catheter colonization," the study authors conclude. "Given the extent of the benefit and the absence of incremental cost, chlorhexidine-based solutions should be considered as a replacement for povidone-iodine (including alcohol-based formulations) in efforts to prevent catheter-related infection."
Centre Hospitalier et Universitaire de Poitiers, Bayer HealthCare, and Viatris Pharmaceuticals supported this study. Dr. Mimoz has served as a consultant to Bayer HealthCare and Viatris Pharmaceuticals.
Arch Intern Med. 2007;167:2066-2072.
October 25, 2007 — Chlorhexidine-based solutions should be considered as a replacement for povidone-iodine formulations, including those that are alcohol based, in efforts to prevent central venous catheter–related infection, according to the results of a study reported in the October 22 issue of the Archives of Internal Medicine.
"Although chlorhexidine-based solutions and alcohol-based povidone-iodine have been shown to be more efficient than aqueous povidone-iodine for skin disinfection at catheter insertion sites, their abilities to reduce catheter-related infection have never been compared," write Olivier Mimoz, MD, PhD, from Centre Hospitalier et Universitaire de Poitiers in France, and colleagues. "Catheter-related bloodstream infections have been reported to occur in 3% to 8% of catheters inserted and are the predominant cause of nosocomial bacteremia in intensive care units (ICUs), with 80,000 cases annually at a cost of $300 million to $2.3 billion."
In this study, 538 consecutively scheduled central venous catheters inserted into jugular or subclavian veins were randomized to be disinfected with 5% povidone-iodine in 70% ethanol or with a combination of 0.25% chlorhexidine gluconate, 0.025% benzalkonium chloride, and 4% benzylic alcohol. These solutions were used before catheter insertion for skin disinfection with 2 consecutive 30-second applications, allowing the skin to dry in between, as well as for single applications during subsequent dressing changes, which were performed every 72 hours or sooner if the dressing became soiled or wet.
Culture results were evaluable in 481 (89.4%) of catheters studied. Compared with use of povidone-iodine, the chlorhexidine-based solution was associated with a 50% reduction in the incidence of catheter colonization (11.6% vs 22.2%; P =.002; incidence density, 9.7 vs 18.3 per 1000 catheter-days). There was also a statistically nonsignificant trend toward lower rates of catheter-related bloodstream infection (1.7% vs 4.2%; P =. 09; incidence density, 1.4 vs 3.4 per 1000 catheter-days).
Risk factors that were independently associated with catheter colonization were catheter insertion into the jugular vein (adjusted relative risk [RR], 2.01; 95% confidence interval [CI], 1.24 - 3.24) and use of povidone-iodine (adjusted RR, 1.87; 95% CI, 1.18 - 2.96).
"Chlorhexidine-based solutions should be considered as a replacement for povidone-iodine (including alcohol-based) formulations in efforts to prevent catheter-related infection," the study authors write.
Limitations of the study include lack of blinding, treatment groups not equally distributed with regard to sex, and insufficient power to demonstrate a significant reduction of catheter-related bloodstream infection.
"Our results demonstrate that the use of a chlorhexidine-based solution rather than povidone-iodine is likely to result in decreased catheter colonization," the study authors conclude. "Given the extent of the benefit and the absence of incremental cost, chlorhexidine-based solutions should be considered as a replacement for povidone-iodine (including alcohol-based formulations) in efforts to prevent catheter-related infection."
Centre Hospitalier et Universitaire de Poitiers, Bayer HealthCare, and Viatris Pharmaceuticals supported this study. Dr. Mimoz has served as a consultant to Bayer HealthCare and Viatris Pharmaceuticals.
Arch Intern Med. 2007;167:2066-2072.
Brain's 'Reward Chemical' May Help Spur Obesity
Thu Oct 25, 6:59 PM ET
THURSDAY, Oct. 25 (HealthDay News) -- A new study provides more evidence that dopamine -- a brain chemical associated with reward, pleasure, movement and motivation -- plays a role in obesity.
Researchers at the U.S. government's Brookhaven National Laboratory in Upton, N.Y., found that genetically obese rats have lower levels of dopamine D2 receptors on brain cells than lean rats. The study also found that restricting food intake can increase the number of D2 receptors on those cells.
"This research corroborates brain-imaging studies conducted at Brookhaven that found decreased levels of dopamine D2 receptors in obese people compared with normal-weight people," lead author and Brookhaven neuroscientist Panayotis (Peter) Thanos, said in a prepared statement.
"This study also provides further evidence for the interplay of genetic factors with the environment in the development of obesity in our society," he added.
It's not clear whether reduced dopamine D2 receptor levels are a cause or consequence of obesity, Thanos said. Overeating may cause a chronic reduction in receptor levels and, over the long term, contribute to obesity. However, genetically influenced low levels of D2 receptors may also cause obesity, because a person may overeat in an attempt to stimulate a "blunted" reward system.
In both cases, increasing dopamine D2 receptor levels by restricting food intake may prove an effective way of combating obesity, Thanos said.
"Consuming fewer calories is obviously important for people trying to lose weight, plus improving the brain's ability to respond to rewards other than food may help prevent overeating," Thanos noted.
The findings are available online and are expected to be published in an upcoming print issue of the journal Synapse.
More information
The U.S. Centers for Disease Control and Prevention has more about overweight/obesity.
Thu Oct 25, 6:59 PM ET
THURSDAY, Oct. 25 (HealthDay News) -- A new study provides more evidence that dopamine -- a brain chemical associated with reward, pleasure, movement and motivation -- plays a role in obesity.
Researchers at the U.S. government's Brookhaven National Laboratory in Upton, N.Y., found that genetically obese rats have lower levels of dopamine D2 receptors on brain cells than lean rats. The study also found that restricting food intake can increase the number of D2 receptors on those cells.
"This research corroborates brain-imaging studies conducted at Brookhaven that found decreased levels of dopamine D2 receptors in obese people compared with normal-weight people," lead author and Brookhaven neuroscientist Panayotis (Peter) Thanos, said in a prepared statement.
"This study also provides further evidence for the interplay of genetic factors with the environment in the development of obesity in our society," he added.
It's not clear whether reduced dopamine D2 receptor levels are a cause or consequence of obesity, Thanos said. Overeating may cause a chronic reduction in receptor levels and, over the long term, contribute to obesity. However, genetically influenced low levels of D2 receptors may also cause obesity, because a person may overeat in an attempt to stimulate a "blunted" reward system.
In both cases, increasing dopamine D2 receptor levels by restricting food intake may prove an effective way of combating obesity, Thanos said.
"Consuming fewer calories is obviously important for people trying to lose weight, plus improving the brain's ability to respond to rewards other than food may help prevent overeating," Thanos noted.
The findings are available online and are expected to be published in an upcoming print issue of the journal Synapse.
More information
The U.S. Centers for Disease Control and Prevention has more about overweight/obesity.
Parkinson's tie to impulsiveness studied
By LAURAN NEERGAARD, AP Medical WriterThu Oct 25, 4:42 PM ET
Your brain is supposed to fire a "hold your horses" signal when faced with a tough choice. But a brain implant that stops the tremors of Parkinson's disease may block that signal — a new explanation for why some Parkinson's patients become hugely impulsive.
Scientists have long known that anti-Parkinson medications occasionally spark compulsions like pathological gambling.
Research published Thursday found another treatment, a pacemaker-like brain implant, can trigger a completely different kind of impulsiveness. How different? The drugs leave a subset of patients unlikely to learn from bad experiences, like a losing poker hand.
The brain implant doesn't hinder learning. In contrast, those patients can make hasty decisions as the brain loses its automatic tendency to hesitate when faced with conflict, University of Arizona researchers reported online in the journal Science.
In fact, the first patient they studied displayed an alarming example when he saw something across the room he wanted and tried to dash over without his wheelchair. Neuroscientist Michael Frank had to catch the man before he fell.
"Deep brain stimulation," or DBS, involves placing electrodes into a small region called the subthalamic nucleus, an area important for controlling movement. But it also is where scientists believe the brain yells: "Stop, weigh your options!"
Frank's theory: When electrodes fire to disrupt excessive movement, they also may block that signal.
"It makes a lot of sense," said Dr. Valerie Voon, a psychiatrist with the National Institutes of Health's neurology center, after reviewing the research.
The study doesn't offer easy solutions. But it could affect how neurologists counsel Parkinson's patients after DBS surgery.
"Because they don't have those brakes in place, you need to teach someone to slow down" when faced with certain decisions, Voon said.
At least 1 million Americans have Parkinson's, suffering increasingly severe tremors and periodically stiff or frozen limbs as brain cells quit producing dopamine, a chemical crucial for movement. There is no cure. Standard treatments include medications to stimulate dopamine and, once those fail, DBS surgery to control tremors.
Doctors have long noticed varying degrees of impulsiveness in Parkinson's patients, from making uncensored remarks to rare cases of extreme behavior such as compulsive gambling, shopping, eating or sex. Changing medications or doses often solves extreme symptoms — if patients or their families report the worrisome behavior.
Frank wondered what role the brain implant plays.
His team used specialized computer games to probe decision-making in 15 Parkinson's patients taking dopamine drugs, 17 others who received DBS, and 14 healthy older adults.
First, participants were shown pairs of Japanese characters and told to pick the "correct" one. It was baffling — what makes one symbol better, especially if you don't know Japanese? But as the computer screen beamed back "Correct!" or "Incorrect!" their brains learned to prefer some characters over others.
Then Frank paired the symbols differently: "Correct" ones together to simulate "win-win" decisions; "incorrect" pairings to model choosing the lesser of two evils; and easy "right-wrong" pairs.
Healthy people and Parkinson's patients on dopamine drugs hesitated briefly when faced with win-win or lose-lose choices, allowing time to weigh options. But DBS patients didn't hesitate with lose-lose choices — and actually sped up win-win decisions.
Remarkably, switch off the brain implant and DBS patients quit rushing the close calls.
As in previous research, medicated patients were less likely to learn which "wrong" symbols to avoid, backing the theory that dopamine drugs can hinder learning from negative feedback.
But do the DBS patients' hasty choices really matter in a win-win situation, where there's no clearly wrong answer?
In the real world, definitely, said Arizona's Frank. Say your job offers a range of 401K options. Sure, any one is better than no investment, but just grabbing the first one might not be the most lucrative.
It hasn't been obvious that different treatments cause different impulsive behaviors, said Dr. Kathleen Shannon of Chicago's Rush University Hospital.
"They all seem to make bad decisions and have trouble making decisions," she said. Now, "I'll start to look at my patients differently."
___
On the Net:
Information on Parkinson's disease:
http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm
By LAURAN NEERGAARD, AP Medical WriterThu Oct 25, 4:42 PM ET
Your brain is supposed to fire a "hold your horses" signal when faced with a tough choice. But a brain implant that stops the tremors of Parkinson's disease may block that signal — a new explanation for why some Parkinson's patients become hugely impulsive.
Scientists have long known that anti-Parkinson medications occasionally spark compulsions like pathological gambling.
Research published Thursday found another treatment, a pacemaker-like brain implant, can trigger a completely different kind of impulsiveness. How different? The drugs leave a subset of patients unlikely to learn from bad experiences, like a losing poker hand.
The brain implant doesn't hinder learning. In contrast, those patients can make hasty decisions as the brain loses its automatic tendency to hesitate when faced with conflict, University of Arizona researchers reported online in the journal Science.
In fact, the first patient they studied displayed an alarming example when he saw something across the room he wanted and tried to dash over without his wheelchair. Neuroscientist Michael Frank had to catch the man before he fell.
"Deep brain stimulation," or DBS, involves placing electrodes into a small region called the subthalamic nucleus, an area important for controlling movement. But it also is where scientists believe the brain yells: "Stop, weigh your options!"
Frank's theory: When electrodes fire to disrupt excessive movement, they also may block that signal.
"It makes a lot of sense," said Dr. Valerie Voon, a psychiatrist with the National Institutes of Health's neurology center, after reviewing the research.
The study doesn't offer easy solutions. But it could affect how neurologists counsel Parkinson's patients after DBS surgery.
"Because they don't have those brakes in place, you need to teach someone to slow down" when faced with certain decisions, Voon said.
At least 1 million Americans have Parkinson's, suffering increasingly severe tremors and periodically stiff or frozen limbs as brain cells quit producing dopamine, a chemical crucial for movement. There is no cure. Standard treatments include medications to stimulate dopamine and, once those fail, DBS surgery to control tremors.
Doctors have long noticed varying degrees of impulsiveness in Parkinson's patients, from making uncensored remarks to rare cases of extreme behavior such as compulsive gambling, shopping, eating or sex. Changing medications or doses often solves extreme symptoms — if patients or their families report the worrisome behavior.
Frank wondered what role the brain implant plays.
His team used specialized computer games to probe decision-making in 15 Parkinson's patients taking dopamine drugs, 17 others who received DBS, and 14 healthy older adults.
First, participants were shown pairs of Japanese characters and told to pick the "correct" one. It was baffling — what makes one symbol better, especially if you don't know Japanese? But as the computer screen beamed back "Correct!" or "Incorrect!" their brains learned to prefer some characters over others.
Then Frank paired the symbols differently: "Correct" ones together to simulate "win-win" decisions; "incorrect" pairings to model choosing the lesser of two evils; and easy "right-wrong" pairs.
Healthy people and Parkinson's patients on dopamine drugs hesitated briefly when faced with win-win or lose-lose choices, allowing time to weigh options. But DBS patients didn't hesitate with lose-lose choices — and actually sped up win-win decisions.
Remarkably, switch off the brain implant and DBS patients quit rushing the close calls.
As in previous research, medicated patients were less likely to learn which "wrong" symbols to avoid, backing the theory that dopamine drugs can hinder learning from negative feedback.
But do the DBS patients' hasty choices really matter in a win-win situation, where there's no clearly wrong answer?
In the real world, definitely, said Arizona's Frank. Say your job offers a range of 401K options. Sure, any one is better than no investment, but just grabbing the first one might not be the most lucrative.
It hasn't been obvious that different treatments cause different impulsive behaviors, said Dr. Kathleen Shannon of Chicago's Rush University Hospital.
"They all seem to make bad decisions and have trouble making decisions," she said. Now, "I'll start to look at my patients differently."
___
On the Net:
Information on Parkinson's disease:
http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm
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