From Medscape Medical News
Emma Hitt, PhD
June 25, 2010 — Straight couples who regularly swap sexual partners, referred to as swingers, have rates of sexually transmitted infections (STIs) comparable with those of other high-risk groups, according to the findings of a new study conducted in the Netherlands.
Nicole H. T. M. Dukers-Muijrers, PhD, from the Department of Infectious Diseases, South Limburg Public Health Service, the Netherlands, and colleagues compared STI prevalence rates in swingers with those of other risk groups.
"Until now, swingers...are not considered as a specific risk group for STI in healthcare services and prevention," note Dr. Dukers-Muijrers and colleagues in their article, published online June 24 in Sexually Transmitted Infections. "Swingers differ from non-swinging heterosexual adults by their sexual network, typed by concurrent sexual partners and high rate of unprotected sex," the authors note.
Since 2007, all attendees at a single STI clinic in South Limburg, the Netherlands, have been asked whether they engage in the practice of swinging. STI clinic surveillance data were analyzed for indications of diagnosis of Chlamydia trachomatis and/or Neisseria gonorrhoeae.
Out of 8921 consultations, 12% reported that they were swingers. The median age was 43 years. The highest STI prevalences were reported in young attendees (age, 16 - 35 years), men who have sex with men, and swingers.
Combined rates of chlamydia and gonorrhea were recorded in more than 10% of heterosexuals, 14% of homosexual men, less than 5% of female prostitutes, and 10.4% of swingers (median age, 43 years). Female swingers had higher infection rates than male swingers (P = .032).
More than half (55%) of all diagnoses in those older than 45 years were made in swingers compared with around a third (31%) in homosexual men. Among swingers older than 45 years, 10% had chlamydia and approximately 4% had gonorrhea.
According to the researchers, no systematic data on STI diagnoses in this heterosexual population exist, except for those presented in the current study. "To our knowledge, no single country mentions swingers as a special focus group in national STI prevention," they add. In the Netherlands, 15,000 couples (30,000 individuals) have a profile on one of the largest Websites for swingers. "The total number of swingers is probably larger," they write.
"Swingers, like other groups with risk behaviors, need to be identified and treated as a risk group in STI prevention and care," the researchers conclude.
The authors have disclosed no relevant financial relationships.
Sex Transm Infect. Published online June 24, 2010.
Friday, June 25, 2010
Omega-3 Supplements May Reduce Depressive Symptoms in Patients Without Comorbid Anxiety
From Medscape Medical News
Deborah Brauser
June 24, 2010 — Omega-3 fatty acid supplements significantly reduce symptoms of major depressive episodes (MDEs) for patients without comorbid anxiety disorders (ADs) compared with those taking placebo, according to a new study of more than 400 patients from 8 Canadian clinics.
However, patients with both MDE and AD showed only a trend toward major symptom reduction after taking the omega-3 supplements.
"To our knowledge, this [trial] is the largest ever conducted testing the efficacy of omega-3 supplements for treating MDE," write lead study author François Lespérance, MD, from the Department of Psychiatry and Centre de Recherché du Centre Hospitalier at the Université de Montréal (CRCHUM), Quebec, Canada, and colleagues.
They note that in designing the most inclusive trial possible, over 80% of their study participants "would have been excluded from the usual type of phase 3 trial (27% chronic depression, 53% comorbid ADs, 40% taking at least 1 antidepressant, and approximately 15% undergoing some form of psychotherapy). This approach resulted in a heterogeneous sample of patients with depression that included many difficult-to-treat individuals."
"While caution is warranted in interpreting most subgroup analysis, the current results of our planned subgroup analysis could lead many unipolar patients with depression without significant anxiety to conclude that omega-3 supplements are worth trying," Dr. Lespérance told Medscape Psychiatry.
The study is published online in the Journal of Clinical Psychiatry.
Antidepressant Alternatives Needed
"Despite the availability of several newer antidepressants over the last 20 years, a substantial proportion of patients experiencing [an MDE] do not respond sufficiently to antidepressant treatment, are unable to tolerate antidepressants in order to obtain or maintain a clinical response, or refuse to take antidepressants despite substantial psychological suffering and disability," write the study authors.
They note that almost 54% of people with depression in the United States use some form of complementary treatment.
"It is clear that there is a need for additional therapeutic options that represent alternatives to standard antidepressants," the study authors write. Although past research has suggested a role for omega-3 in treating depression, "the level of evidence is still insufficient."
For this study, 432 adult outpatients (mean age, 46 years; 68.5% female) with an MDE lasting at least 4 weeks were enrolled at 1 of 8 Canadian academic and psychiatric clinics between October 2005 and January 2009.
All patients were randomized to receive 8 weeks of either omega-3 supplements (including 1050 mg of eicosapentaenoic acid and 150 mg of docosahexaenoic acid daily, n = 218) or matched doses of sunflower oil placebo (n = 214). To strengthen the double-blind and limit the potential bias of a fishy aftertaste often reported by those taking omega-3, 2% fish oil was added to the placebo.
Antidepressants were also used at baseline by 40.3% of the patients, and clinic visits were made by all at weeks 1, 2, 4, and 8.
The study's primary outcome measure was the self-report score from the 30-item Inventory of Depressive Symptomatology (IDS-SR30), whereas the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) was the secondary efficacy outcome measure.
Subgroup analysis was also conducted based on the presence or absence of comorbid AD at baseline, use of antidepressants, patient sex, and number of portions of fish per week during the month before the study's initiation.
Only MDE Patients Without ADs Had Significant Improvements
Results showed that the adjusted mean difference between the omega-3 treatment and the placebo treatment was 1.32 points (95% confidence interval [CI], −0.20 to 2.84; P = .088) on the IDS-SR30 and 0.97 points (95% CI, −0.012 to 1.95; P = .053) on the MADRS, neither of which was statistically significant.
"This could have been due in part to including patients with [ADs], who tend to be more difficult to treat," explained Dr. Lespérance. "The neurobiology of anxiety disorders or the combination of conditions may have reduced the capacity to distinguish the effect between placebo and active treatment. Whereas if we had a more pure group of depressed patients, such as those most often included in these types of trials, we could possibly have gotten the same sort of effect we find with other antidepressants."
In the subgroup analyses, no evidence of interactions was found for antidepressant use at baseline, patient sex, or fish intake before the study. However, "the interaction of comorbid [ADs] and study group was significant (P = .035), suggesting heterogeneity of the [treatment] efficacy," report the study authors. A total of 52.8% of the total patients were found to have comorbid ADs.
For the 204 patients without comorbid ADs, those taking the omega-3 supplements had significantly fewer depressive symptoms compared with those taking placebo — shown by an adjusted mean difference of 3.17 points on the IDS-SR30 (95% CI, 0.89 − 5.45; P = .007) and 1.93 points on the MADRS (95% CI, 0.50 − 3.36; P = .008).
In addition, the omega-3 supplements "seemed to be more efficacious for patients as a stand-alone treatment in comparison to adjuvant treatment," reported Dr. Lespérance.
A total of 46.2% of the patients treated with omega-3 and 53.4% of those treated with placebo reported no medication-attributed adverse effects. There were 7 serious adverse events in the omega-3 group and 4 reported in the placebo group.
"I think this study should and will trigger more interest in doing trials with less conventional treatments for depression, such as those looking at exercise and yoga, as well as looking more at the link between omega-3 and inflammation," said Dr. Lespérance.
He notes that his team hopes to next look at a head-to-head comparison trial between omega-3 supplements and antidepressant medications. "With this, we'd like to see if we can find out what the predictors are for a better response from either omega-3 or commercial antidepressants."
Efficacy Despite Obstacles
"When I look at this trial, I see that despite setting themselves up for failure, [the investigators] reported a treatment efficacy comparable to other antidepressants," CAPT Joseph R. Hibbeln, MD, acting chief of the Section on Nutritional Neurosciences at the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, in Bethesda, Maryland, told Medscape Psychiatry.
Dr. Hibbeln, who was not involved with this study, explained that he has 20 years of experience in this field and "originated the hypothesis" about omega-3 in depression in 1995. "So I've seen many studies and watched the development of this field. Overall, this is quite an expected result, and it has to be taken in comparison to other trials of antidepressants in similar populations to really appreciate the effectiveness demonstrated here."
He noted that in 2002 the US Food and Drug Administration (FDA) recognized that the likelihood of seeing a benefit in an antidepressant trial depends on how depressed the patients are at baseline. "For example, trials of fluoxetine will show effects in severe and moderately severe patients but not in mild or moderate patients. And that's because of scoring and the statistics of depression.
"However, in this study, the patients had moderate severity, it's a population of exceptionally difficult to treat patients, and it was a very heterogeneous sample," added Dr. Hibbeln. "Statistically, in comparison with other antidepressant trials of similar populations, this is exactly what we would expect to see for a successful antidepressant. It demonstrated efficacy despite these factors and despite — and this is the critical piece — absolutely no biological validation of compliance."
When asked what he would recommend to clinicians, Dr. Hibbeln said that he would urge a "paradigm shift." Instead of treating with medicine first and then correcting the nutritional deficiency only after the medicine failed, he recommends correcting the deficiency first and then, if it is not successful, turning to medicine.
In addition, he reported that in 2006, the treatment recommendation committee for the American Psychiatric Association (APA), of which he was a member, issued recommendations that all psychiatric patients should take at least 1 g per day of omega-3 fatty acids. "The rationale was that psychiatric patients are at a much higher risk for cardiovascular disease and metabolic problems. And we have clear and unequivocal evidence that omega-3 fatty acids improve these factors.
"Plus, one of the major complications noted in second-generation antipsychotics is hypertriglyceridemia, and the most effective FDA-approved and insurance-reimbursable treatment for this is omega-3 fatty acids," he added. "And as recently as 2 weeks ago, the US dietary guidelines recommended eating fish 2 to 3 times a week for the general population.
"So should clinicians follow the guidelines from the FDA, the USDA [US Department of Agriculture], and the American Heart Association about fish intake and omega-3? And should they follow the [APA] treatment recommendations to prevent comorbid problems? Yes! And, oh by the way, correcting this nutritional deficiency is as effective as antidepressants," said Dr. Hibbeln. "It really is a no-brainer."
He also noted that patients "don't have to guess as to what their omega-3 fatty acid status is" because finger-prick blood tests are now readily available. "With this, physicians and patients can get direct assessment of fatty acid levels and psychiatric and cardiovascular risk."
This study was supported by the Fondation du Centre Hospitalier de l'Université de Montréal and the CRCHUM and by an unrestricted grant from Isodis Natura. Although Dr. Lespérance has disclosed no relevant financial relationships, 3 of the other study authors reported several potential conflicts. The full list of disclosures is listed in the original article. Dr. Hibbeln has reported no relevant financial relationships.
J Clin Psychiatry. Published online June 15, 2010.
Deborah Brauser
June 24, 2010 — Omega-3 fatty acid supplements significantly reduce symptoms of major depressive episodes (MDEs) for patients without comorbid anxiety disorders (ADs) compared with those taking placebo, according to a new study of more than 400 patients from 8 Canadian clinics.
However, patients with both MDE and AD showed only a trend toward major symptom reduction after taking the omega-3 supplements.
"To our knowledge, this [trial] is the largest ever conducted testing the efficacy of omega-3 supplements for treating MDE," write lead study author François Lespérance, MD, from the Department of Psychiatry and Centre de Recherché du Centre Hospitalier at the Université de Montréal (CRCHUM), Quebec, Canada, and colleagues.
They note that in designing the most inclusive trial possible, over 80% of their study participants "would have been excluded from the usual type of phase 3 trial (27% chronic depression, 53% comorbid ADs, 40% taking at least 1 antidepressant, and approximately 15% undergoing some form of psychotherapy). This approach resulted in a heterogeneous sample of patients with depression that included many difficult-to-treat individuals."
"While caution is warranted in interpreting most subgroup analysis, the current results of our planned subgroup analysis could lead many unipolar patients with depression without significant anxiety to conclude that omega-3 supplements are worth trying," Dr. Lespérance told Medscape Psychiatry.
The study is published online in the Journal of Clinical Psychiatry.
Antidepressant Alternatives Needed
"Despite the availability of several newer antidepressants over the last 20 years, a substantial proportion of patients experiencing [an MDE] do not respond sufficiently to antidepressant treatment, are unable to tolerate antidepressants in order to obtain or maintain a clinical response, or refuse to take antidepressants despite substantial psychological suffering and disability," write the study authors.
They note that almost 54% of people with depression in the United States use some form of complementary treatment.
"It is clear that there is a need for additional therapeutic options that represent alternatives to standard antidepressants," the study authors write. Although past research has suggested a role for omega-3 in treating depression, "the level of evidence is still insufficient."
For this study, 432 adult outpatients (mean age, 46 years; 68.5% female) with an MDE lasting at least 4 weeks were enrolled at 1 of 8 Canadian academic and psychiatric clinics between October 2005 and January 2009.
All patients were randomized to receive 8 weeks of either omega-3 supplements (including 1050 mg of eicosapentaenoic acid and 150 mg of docosahexaenoic acid daily, n = 218) or matched doses of sunflower oil placebo (n = 214). To strengthen the double-blind and limit the potential bias of a fishy aftertaste often reported by those taking omega-3, 2% fish oil was added to the placebo.
Antidepressants were also used at baseline by 40.3% of the patients, and clinic visits were made by all at weeks 1, 2, 4, and 8.
The study's primary outcome measure was the self-report score from the 30-item Inventory of Depressive Symptomatology (IDS-SR30), whereas the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) was the secondary efficacy outcome measure.
Subgroup analysis was also conducted based on the presence or absence of comorbid AD at baseline, use of antidepressants, patient sex, and number of portions of fish per week during the month before the study's initiation.
Only MDE Patients Without ADs Had Significant Improvements
Results showed that the adjusted mean difference between the omega-3 treatment and the placebo treatment was 1.32 points (95% confidence interval [CI], −0.20 to 2.84; P = .088) on the IDS-SR30 and 0.97 points (95% CI, −0.012 to 1.95; P = .053) on the MADRS, neither of which was statistically significant.
"This could have been due in part to including patients with [ADs], who tend to be more difficult to treat," explained Dr. Lespérance. "The neurobiology of anxiety disorders or the combination of conditions may have reduced the capacity to distinguish the effect between placebo and active treatment. Whereas if we had a more pure group of depressed patients, such as those most often included in these types of trials, we could possibly have gotten the same sort of effect we find with other antidepressants."
In the subgroup analyses, no evidence of interactions was found for antidepressant use at baseline, patient sex, or fish intake before the study. However, "the interaction of comorbid [ADs] and study group was significant (P = .035), suggesting heterogeneity of the [treatment] efficacy," report the study authors. A total of 52.8% of the total patients were found to have comorbid ADs.
For the 204 patients without comorbid ADs, those taking the omega-3 supplements had significantly fewer depressive symptoms compared with those taking placebo — shown by an adjusted mean difference of 3.17 points on the IDS-SR30 (95% CI, 0.89 − 5.45; P = .007) and 1.93 points on the MADRS (95% CI, 0.50 − 3.36; P = .008).
In addition, the omega-3 supplements "seemed to be more efficacious for patients as a stand-alone treatment in comparison to adjuvant treatment," reported Dr. Lespérance.
A total of 46.2% of the patients treated with omega-3 and 53.4% of those treated with placebo reported no medication-attributed adverse effects. There were 7 serious adverse events in the omega-3 group and 4 reported in the placebo group.
"I think this study should and will trigger more interest in doing trials with less conventional treatments for depression, such as those looking at exercise and yoga, as well as looking more at the link between omega-3 and inflammation," said Dr. Lespérance.
He notes that his team hopes to next look at a head-to-head comparison trial between omega-3 supplements and antidepressant medications. "With this, we'd like to see if we can find out what the predictors are for a better response from either omega-3 or commercial antidepressants."
Efficacy Despite Obstacles
"When I look at this trial, I see that despite setting themselves up for failure, [the investigators] reported a treatment efficacy comparable to other antidepressants," CAPT Joseph R. Hibbeln, MD, acting chief of the Section on Nutritional Neurosciences at the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, in Bethesda, Maryland, told Medscape Psychiatry.
Dr. Hibbeln, who was not involved with this study, explained that he has 20 years of experience in this field and "originated the hypothesis" about omega-3 in depression in 1995. "So I've seen many studies and watched the development of this field. Overall, this is quite an expected result, and it has to be taken in comparison to other trials of antidepressants in similar populations to really appreciate the effectiveness demonstrated here."
He noted that in 2002 the US Food and Drug Administration (FDA) recognized that the likelihood of seeing a benefit in an antidepressant trial depends on how depressed the patients are at baseline. "For example, trials of fluoxetine will show effects in severe and moderately severe patients but not in mild or moderate patients. And that's because of scoring and the statistics of depression.
"However, in this study, the patients had moderate severity, it's a population of exceptionally difficult to treat patients, and it was a very heterogeneous sample," added Dr. Hibbeln. "Statistically, in comparison with other antidepressant trials of similar populations, this is exactly what we would expect to see for a successful antidepressant. It demonstrated efficacy despite these factors and despite — and this is the critical piece — absolutely no biological validation of compliance."
When asked what he would recommend to clinicians, Dr. Hibbeln said that he would urge a "paradigm shift." Instead of treating with medicine first and then correcting the nutritional deficiency only after the medicine failed, he recommends correcting the deficiency first and then, if it is not successful, turning to medicine.
In addition, he reported that in 2006, the treatment recommendation committee for the American Psychiatric Association (APA), of which he was a member, issued recommendations that all psychiatric patients should take at least 1 g per day of omega-3 fatty acids. "The rationale was that psychiatric patients are at a much higher risk for cardiovascular disease and metabolic problems. And we have clear and unequivocal evidence that omega-3 fatty acids improve these factors.
"Plus, one of the major complications noted in second-generation antipsychotics is hypertriglyceridemia, and the most effective FDA-approved and insurance-reimbursable treatment for this is omega-3 fatty acids," he added. "And as recently as 2 weeks ago, the US dietary guidelines recommended eating fish 2 to 3 times a week for the general population.
"So should clinicians follow the guidelines from the FDA, the USDA [US Department of Agriculture], and the American Heart Association about fish intake and omega-3? And should they follow the [APA] treatment recommendations to prevent comorbid problems? Yes! And, oh by the way, correcting this nutritional deficiency is as effective as antidepressants," said Dr. Hibbeln. "It really is a no-brainer."
He also noted that patients "don't have to guess as to what their omega-3 fatty acid status is" because finger-prick blood tests are now readily available. "With this, physicians and patients can get direct assessment of fatty acid levels and psychiatric and cardiovascular risk."
This study was supported by the Fondation du Centre Hospitalier de l'Université de Montréal and the CRCHUM and by an unrestricted grant from Isodis Natura. Although Dr. Lespérance has disclosed no relevant financial relationships, 3 of the other study authors reported several potential conflicts. The full list of disclosures is listed in the original article. Dr. Hibbeln has reported no relevant financial relationships.
J Clin Psychiatry. Published online June 15, 2010.
Thursday, June 24, 2010
John Bartlett's Postmortem on 2009 H1N1 (Influenza A): 10 Valuable Lessons
From Medscape Infectious Diseases
John G. Bartlett, MD
It may be premature for this analysis since we have had 2 waves of influenza and no one can exclude the possibility of a third wave. Nevertheless, it is a good time to gather the major lessons learned to date. My "top 10" list (in no particular order) is the following:
1. Current surveillance systems do not seem to work. Before the 2009 (H1N1) pandemic began, it was believed that the next pandemic would come from Asia, where surveillance systems were established on the basis of this prediction. The next pandemic was supposed to be a new strain of influenza such as H5N1, and it was expected to be associated with a high mortality rate. Instead, the pandemic came from Mexico, it involved a variant of H1N1 (the oldest of all known strains), and the mortality seemed extraordinarily low, about 0.02% compared with mortality from Spanish flu, which at 2.4% was about 100-fold more lethal.
2. New risks for infection have emerged. The highest incidence of infection was in the age category 10-19 years, and most cases, by far, occurred in persons < 50 years of age. In addition to young age as a risk factor, other important and somewhat surprising risks for poor outcome were obesity and pregnancy. For instance, the odds ratio for death among patients with morbid obesity (body mass index > 40 kg/m2) was 7.6.[1] Among pregnant women, the odds ratio for admission to the intensive care unit was 7.4 for all pregnant women and 13.2 for those in the third trimester.[2]
3. The mortality data are deceptive. Total mortality estimated by the Centers for Disease Control and Prevention (CDC) was approximately 12,300 persons in the United States. As noted, this flu seemed to displace seasonal influenza almost completely, and the anticipated annual mortality rate associated with seasonal flu is 36,000. Thus, a glance at the numbers appears to show a great advantage for the pandemic (H1N1). However, with seasonal flu, 90% of lethal cases are in persons > 65 years of age; in pandemic flu for 2009, almost 90% of deaths were in persons < 65 years of age. Analysis of these data by life-years lost indicates that this pandemic influenza was substantially worse than most flu seasons.[3]
4. Universal vaccine for influenza is beneficial. A series of reports by Kwong and colleagues from Ontario, Canada compared outcomes of universal influenza vaccination in Ontario with those in Canadian provinces that did not have recommendations for universal vaccination.[4-6] The team from Ontario documented a reduction in illness that translated to 144,000 fewer cases by analyzing the number of respiratory antibiotic prescriptions before and after institution of universal vaccination.[4] Further research on this project indicated a 40%-70% reduction in rates of mortality, hospitalization, use of the emergency department, and physician visits.[5] Economic analyses showed that universal vaccination was also highly cost-effective.[6] This experience is particularly important in view of the recent recommendation by the CDC for influenza vaccine for all persons in the United States > 6 months of age. It must be emphasized that this simply means that vaccination is recommended, but it is up to us to make it work. Influenza vaccination must be readily available in malls, work places, and pharmacies, and it must be cheap or free.
5. Healthcare workers need to receive influenza vaccination. The incredibly embarrassing record of healthcare workers (HCWs) in getting influenza vaccination has been discussed often. In most years, the rate of HCW vaccination averages about 45%-50%, but for the 2009 H1N1 strain the national rate for HCWs was only 36%. The issue of mandatory vaccination for HCWs was also controversial. One healthcare system (BJC HealthCare, St. Louis, Missouri) found that in most seasons, only 32%-54% of HCWs in their system received the influenza vaccine, so BJC made it mandatory as a contingency of employment. With this policy, a vaccination rate for 25,980 HCWs of 98.4% was reported; 0.4% had religious exemptions, 1.2% had medical exemptions, and 8 were fired.[7]
6. The surgical mask wins (maybe). The continuing debate about the relative merits of the N95 respirator mask versus the standard surgical mask to prevent transmission of influenza virus among HCWs was tested in Canada.[8] The study included 478 nurses who were randomly assigned to use either the N95 mask or a conventional surgical mask. The nurses were monitored for evidence of influenza or other viral respiratory tract infections. Of nurses with complete follow-up, the results for surgical masks showed infections in 50 of 212 (24%) compared with 48 of 210 (23%) in nurses who wore fit-tested N95 masks. The investigators concluded that the surgical and N95 masks are equally effective, but surgical masks were also cheap, comfortable, and in great supply. More recently, the Society for Hospital Epidemiology of America (SHEA) at their April 2010 meeting voted to recommend surgical masks.[9] (Note: the CDC still seems to favor the N95 fit-tested masksthat we all hate, but this might change).
7. The epidemic can be tracked with the Internet. The New England Journal of Medicine developed a somewhat novel method of tracking the epidemic of influenza around the world by using news reports and health reports from diverse sources.[10] Some 87,000 sources of information were "filtered" for validity and then used to display a time sequence for global dissemination of influenza, which was readily available to anyone with Internet access. It should be noted that Google did something similar by identifying and tracking the keywords used by consumers seeking information about influenza-like illness. Google was then able to map the US epidemic in real time, and could even predict epidemics about 2 weeks earlier than the CDC.[11]
8. Vaccine production needs to be improved. The current vaccine production system requires eggs and takes 6 months. This year's epidemic was a painful example of our current limitations in vaccine production capacity and speed -- the promised large supply of vaccine did not arrive until the second peak had already started to decline. New technologies are now being pursued that will shorten the production time and magnify the yield by using molecular techniques.[12]
9. Diagnostic testing faces limitations. Polymerase chain reaction has now replaced culture as the gold standard for influenza virus detection. The rapid test used in emergency departments and clinic settings has good specificity but sensitivity of only 60%-70%; thus, a negative test result does not exclude the diagnosis of influenza. This point is emphasized by the many diagnostic errors that resulted in withholding treatment from some patients who needed it.[13]
10. How did the 2009 pandemic (H1N1) kill patients? Early reports showed that primary influenza pneumonia caused by 2009 pandemic (H1N1) histopathologically resembled the highly fatal avian (H5N1) infection.[14] The pathology of 2009 H1N1 (diffuse alveolar damage, intra-alveolar hemorrhage, and the detection of viral antigens within pneumocytes) is quite different from what is found after death from the usual seasonal flu. The other major factor that contributed to pulmonary failure with 2009 (H1N1) was bacterial infection, which was found by the CDC by using a special stain technique, in about one third of fatal cases.[15] Less surprising was the fact that some of the same pathogens found with bacterial infections in the pandemic of 1918-1919 (Streptococcus pneumoniae, Staphylococcus aureus, and group A streptococci) were also found with 2009 (H1N1) influenza-associated infections.[16] These are treatable pathogens, a fact that is important to remember in seriously ill patients.
Summary
The experience with the 2009 Influenza H1N1 pandemic may be the most instructive flu season we have had in decades. Almost unprecedented engagement of the public was evident: public health officials, government, science, and industry. Many will count and lament the failures, but the truth is that we are likely to be much better prepared to deal with multiple influenza-related issues in the future. These include issues about masks, surge capacity, universal vaccine, use of Internet for communications and epidemiology, diagnostic testing, and school closing as an attempt (although failed) to control influenza. What we still don't know is how to get people vaccinated, how to optionally use antiviral drugs, how to make a vaccine in large amounts in less than 6 months, and how to define a pandemic.
References
John G. Bartlett, MD
It may be premature for this analysis since we have had 2 waves of influenza and no one can exclude the possibility of a third wave. Nevertheless, it is a good time to gather the major lessons learned to date. My "top 10" list (in no particular order) is the following:
1. Current surveillance systems do not seem to work. Before the 2009 (H1N1) pandemic began, it was believed that the next pandemic would come from Asia, where surveillance systems were established on the basis of this prediction. The next pandemic was supposed to be a new strain of influenza such as H5N1, and it was expected to be associated with a high mortality rate. Instead, the pandemic came from Mexico, it involved a variant of H1N1 (the oldest of all known strains), and the mortality seemed extraordinarily low, about 0.02% compared with mortality from Spanish flu, which at 2.4% was about 100-fold more lethal.
2. New risks for infection have emerged. The highest incidence of infection was in the age category 10-19 years, and most cases, by far, occurred in persons < 50 years of age. In addition to young age as a risk factor, other important and somewhat surprising risks for poor outcome were obesity and pregnancy. For instance, the odds ratio for death among patients with morbid obesity (body mass index > 40 kg/m2) was 7.6.[1] Among pregnant women, the odds ratio for admission to the intensive care unit was 7.4 for all pregnant women and 13.2 for those in the third trimester.[2]
3. The mortality data are deceptive. Total mortality estimated by the Centers for Disease Control and Prevention (CDC) was approximately 12,300 persons in the United States. As noted, this flu seemed to displace seasonal influenza almost completely, and the anticipated annual mortality rate associated with seasonal flu is 36,000. Thus, a glance at the numbers appears to show a great advantage for the pandemic (H1N1). However, with seasonal flu, 90% of lethal cases are in persons > 65 years of age; in pandemic flu for 2009, almost 90% of deaths were in persons < 65 years of age. Analysis of these data by life-years lost indicates that this pandemic influenza was substantially worse than most flu seasons.[3]
4. Universal vaccine for influenza is beneficial. A series of reports by Kwong and colleagues from Ontario, Canada compared outcomes of universal influenza vaccination in Ontario with those in Canadian provinces that did not have recommendations for universal vaccination.[4-6] The team from Ontario documented a reduction in illness that translated to 144,000 fewer cases by analyzing the number of respiratory antibiotic prescriptions before and after institution of universal vaccination.[4] Further research on this project indicated a 40%-70% reduction in rates of mortality, hospitalization, use of the emergency department, and physician visits.[5] Economic analyses showed that universal vaccination was also highly cost-effective.[6] This experience is particularly important in view of the recent recommendation by the CDC for influenza vaccine for all persons in the United States > 6 months of age. It must be emphasized that this simply means that vaccination is recommended, but it is up to us to make it work. Influenza vaccination must be readily available in malls, work places, and pharmacies, and it must be cheap or free.
5. Healthcare workers need to receive influenza vaccination. The incredibly embarrassing record of healthcare workers (HCWs) in getting influenza vaccination has been discussed often. In most years, the rate of HCW vaccination averages about 45%-50%, but for the 2009 H1N1 strain the national rate for HCWs was only 36%. The issue of mandatory vaccination for HCWs was also controversial. One healthcare system (BJC HealthCare, St. Louis, Missouri) found that in most seasons, only 32%-54% of HCWs in their system received the influenza vaccine, so BJC made it mandatory as a contingency of employment. With this policy, a vaccination rate for 25,980 HCWs of 98.4% was reported; 0.4% had religious exemptions, 1.2% had medical exemptions, and 8 were fired.[7]
6. The surgical mask wins (maybe). The continuing debate about the relative merits of the N95 respirator mask versus the standard surgical mask to prevent transmission of influenza virus among HCWs was tested in Canada.[8] The study included 478 nurses who were randomly assigned to use either the N95 mask or a conventional surgical mask. The nurses were monitored for evidence of influenza or other viral respiratory tract infections. Of nurses with complete follow-up, the results for surgical masks showed infections in 50 of 212 (24%) compared with 48 of 210 (23%) in nurses who wore fit-tested N95 masks. The investigators concluded that the surgical and N95 masks are equally effective, but surgical masks were also cheap, comfortable, and in great supply. More recently, the Society for Hospital Epidemiology of America (SHEA) at their April 2010 meeting voted to recommend surgical masks.[9] (Note: the CDC still seems to favor the N95 fit-tested masksthat we all hate, but this might change).
7. The epidemic can be tracked with the Internet. The New England Journal of Medicine developed a somewhat novel method of tracking the epidemic of influenza around the world by using news reports and health reports from diverse sources.[10] Some 87,000 sources of information were "filtered" for validity and then used to display a time sequence for global dissemination of influenza, which was readily available to anyone with Internet access. It should be noted that Google did something similar by identifying and tracking the keywords used by consumers seeking information about influenza-like illness. Google was then able to map the US epidemic in real time, and could even predict epidemics about 2 weeks earlier than the CDC.[11]
8. Vaccine production needs to be improved. The current vaccine production system requires eggs and takes 6 months. This year's epidemic was a painful example of our current limitations in vaccine production capacity and speed -- the promised large supply of vaccine did not arrive until the second peak had already started to decline. New technologies are now being pursued that will shorten the production time and magnify the yield by using molecular techniques.[12]
9. Diagnostic testing faces limitations. Polymerase chain reaction has now replaced culture as the gold standard for influenza virus detection. The rapid test used in emergency departments and clinic settings has good specificity but sensitivity of only 60%-70%; thus, a negative test result does not exclude the diagnosis of influenza. This point is emphasized by the many diagnostic errors that resulted in withholding treatment from some patients who needed it.[13]
10. How did the 2009 pandemic (H1N1) kill patients? Early reports showed that primary influenza pneumonia caused by 2009 pandemic (H1N1) histopathologically resembled the highly fatal avian (H5N1) infection.[14] The pathology of 2009 H1N1 (diffuse alveolar damage, intra-alveolar hemorrhage, and the detection of viral antigens within pneumocytes) is quite different from what is found after death from the usual seasonal flu. The other major factor that contributed to pulmonary failure with 2009 (H1N1) was bacterial infection, which was found by the CDC by using a special stain technique, in about one third of fatal cases.[15] Less surprising was the fact that some of the same pathogens found with bacterial infections in the pandemic of 1918-1919 (Streptococcus pneumoniae, Staphylococcus aureus, and group A streptococci) were also found with 2009 (H1N1) influenza-associated infections.[16] These are treatable pathogens, a fact that is important to remember in seriously ill patients.
Summary
The experience with the 2009 Influenza H1N1 pandemic may be the most instructive flu season we have had in decades. Almost unprecedented engagement of the public was evident: public health officials, government, science, and industry. Many will count and lament the failures, but the truth is that we are likely to be much better prepared to deal with multiple influenza-related issues in the future. These include issues about masks, surge capacity, universal vaccine, use of Internet for communications and epidemiology, diagnostic testing, and school closing as an attempt (although failed) to control influenza. What we still don't know is how to get people vaccinated, how to optionally use antiviral drugs, how to make a vaccine in large amounts in less than 6 months, and how to define a pandemic.
References
Getting Kids to Move -- Try Some of These Tips
From Medscape Internal Medicine
Felicia D. Stoler, DCN, MS, RD
I am a registered dietitian and exercise physiologist, and we are recording this video from the American College of Sports Medicine's annual meeting in Baltimore. What I would like to speak with you today about is the topic of childhood obesity, and, specifically, I would like to address exercise and childhood obesity because diet and exercise are the least expensive, least invasive, and most effective ways to prevent and treat disease, but it is up to you as a physician to instruct your patients and inform them that they need to do the exercise.
In making recommendations to parents about their kids, the easiest thing to do is start with asking the question of what is it that you are doing now, because when you are making a recommendation to change a behavior, you need to know what the behavior is.
With exercise, I like to always start with the basic, which is walking, and most people can walk anywhere. It does not involve a lot of cost and it is something that most of us can do, So, increasing steps -- how do we increase steps? Maybe recommend a pedometer, which can be a low-cost item and can actually be something that is fun for a family to do. Have a parent and child clip on a pedometer, measure their steps, and see how many steps they take every day. And can they increase that? Then, you could turn that into a lesson: How far did we walk, or did we walk across our city, or did we walk across the state?
That is a really simple thing to start with, like going to a playground and exercising or running around and playing -- putting the play back in the playground. Even for a parent to get on a swing with a child, I know for myself as a parent, when I started pumping my legs on a swing, I realized, "wow, this is a really great workout." I also realized that maybe I cannot hold myself up on a monkey bar anymore either, and that was something to work towards as a family. So, when I am having fun with my kids playing in the playground, it sets a good example.
Asking parents to lead by example is really important. It is not just running around and playing because I told you to. I need to do that as well. So, when speaking to parents about what their kids do, maybe it is also speaking to the parents about what they do and how they can be more active as a family.
Something else that is really easy and simple to do is just to put on music in your house and dance -- and dancing with your kids and letting them get up and move and feel the music, and -- hopefully it is a safe environment in your home -- so that is something that is real simple that does not cost anything. That is a way of increasing physical activity.
Using the term "physical activity" is something I have noticed over the years of counseling that is really key. When you say the word "exercise" to parents and to others, they get very intimidated. That word somehow means something that involves excessive perspiration and a very high out-of-breath heart rate, and wearing some skimpy clothes. So in speaking with your patients about physical activity, it is really important to emphasize that every little bit counts. So every 5 minutes or 10 minutes, it all adds to the big number of 30-60 minutes a day that you should be recommending that families exercise and do physical activity.
Now, I know that you are telling your parents that their kids should not be watching more than 2 hours of television a day, or as I like to say, less than 2 hours of technology time, but if kids are watching TV, you can ask parents to think about commercial breaks as an opportunity to get up and do some exercises. Instead of flipping the channel to find something else on TV, can you get up and do jumping jacks? Can you do push-ups? Can you do sit-ups? Can parents and kids do squats and lunges? These are things that, again, do not have to take up a lot of time. You do not need other resources or equipment to do that, and it can be done while you are doing something else. As a clinician, I find that very helpful.
I know that parents welcome the opportunity to learn about ways they can increase their physical activity -- the way they can get their kids to be physically active and make it fun and make it easy. You know, if I have to ask them to go someplace else to do it, they may not be apt to doing that. So, another way to encourage physical activity is that parents and families can go to parks and playgrounds to look for recreational things to do. Obviously, there is the playground setting, but a lot of parks have trails, and some have fitness trails. Sometimes just walking with kids or going on a hike can be a lot of fun and good exercise for the whole family to do together.
If people live in areas where they can bike safely, that is another great exercise, especially for kids. They enjoy it. As a parent and as a mom, what I have learned is that my kids love biking, and as they have gotten older, what has been really nice for them is that they have learned how to bike for longer distances, so we sometimes make a destination to go someplace. While it may not be safe to bike in my community, we will take our car someplace where it is safe, and we then bike together.
The important thing for you as a physician is to make sure that you make the recommendation and make the suggestion, because if you do not make it, the parents will not know.
http://www.medscape.com/viewarticle/723397?src=mp&spon=9&uac=71630FV
Felicia D. Stoler, DCN, MS, RD
I am a registered dietitian and exercise physiologist, and we are recording this video from the American College of Sports Medicine's annual meeting in Baltimore. What I would like to speak with you today about is the topic of childhood obesity, and, specifically, I would like to address exercise and childhood obesity because diet and exercise are the least expensive, least invasive, and most effective ways to prevent and treat disease, but it is up to you as a physician to instruct your patients and inform them that they need to do the exercise.
In making recommendations to parents about their kids, the easiest thing to do is start with asking the question of what is it that you are doing now, because when you are making a recommendation to change a behavior, you need to know what the behavior is.
With exercise, I like to always start with the basic, which is walking, and most people can walk anywhere. It does not involve a lot of cost and it is something that most of us can do, So, increasing steps -- how do we increase steps? Maybe recommend a pedometer, which can be a low-cost item and can actually be something that is fun for a family to do. Have a parent and child clip on a pedometer, measure their steps, and see how many steps they take every day. And can they increase that? Then, you could turn that into a lesson: How far did we walk, or did we walk across our city, or did we walk across the state?
That is a really simple thing to start with, like going to a playground and exercising or running around and playing -- putting the play back in the playground. Even for a parent to get on a swing with a child, I know for myself as a parent, when I started pumping my legs on a swing, I realized, "wow, this is a really great workout." I also realized that maybe I cannot hold myself up on a monkey bar anymore either, and that was something to work towards as a family. So, when I am having fun with my kids playing in the playground, it sets a good example.
Asking parents to lead by example is really important. It is not just running around and playing because I told you to. I need to do that as well. So, when speaking to parents about what their kids do, maybe it is also speaking to the parents about what they do and how they can be more active as a family.
Something else that is really easy and simple to do is just to put on music in your house and dance -- and dancing with your kids and letting them get up and move and feel the music, and -- hopefully it is a safe environment in your home -- so that is something that is real simple that does not cost anything. That is a way of increasing physical activity.
Using the term "physical activity" is something I have noticed over the years of counseling that is really key. When you say the word "exercise" to parents and to others, they get very intimidated. That word somehow means something that involves excessive perspiration and a very high out-of-breath heart rate, and wearing some skimpy clothes. So in speaking with your patients about physical activity, it is really important to emphasize that every little bit counts. So every 5 minutes or 10 minutes, it all adds to the big number of 30-60 minutes a day that you should be recommending that families exercise and do physical activity.
Now, I know that you are telling your parents that their kids should not be watching more than 2 hours of television a day, or as I like to say, less than 2 hours of technology time, but if kids are watching TV, you can ask parents to think about commercial breaks as an opportunity to get up and do some exercises. Instead of flipping the channel to find something else on TV, can you get up and do jumping jacks? Can you do push-ups? Can you do sit-ups? Can parents and kids do squats and lunges? These are things that, again, do not have to take up a lot of time. You do not need other resources or equipment to do that, and it can be done while you are doing something else. As a clinician, I find that very helpful.
I know that parents welcome the opportunity to learn about ways they can increase their physical activity -- the way they can get their kids to be physically active and make it fun and make it easy. You know, if I have to ask them to go someplace else to do it, they may not be apt to doing that. So, another way to encourage physical activity is that parents and families can go to parks and playgrounds to look for recreational things to do. Obviously, there is the playground setting, but a lot of parks have trails, and some have fitness trails. Sometimes just walking with kids or going on a hike can be a lot of fun and good exercise for the whole family to do together.
If people live in areas where they can bike safely, that is another great exercise, especially for kids. They enjoy it. As a parent and as a mom, what I have learned is that my kids love biking, and as they have gotten older, what has been really nice for them is that they have learned how to bike for longer distances, so we sometimes make a destination to go someplace. While it may not be safe to bike in my community, we will take our car someplace where it is safe, and we then bike together.
The important thing for you as a physician is to make sure that you make the recommendation and make the suggestion, because if you do not make it, the parents will not know.
http://www.medscape.com/viewarticle/723397?src=mp&spon=9&uac=71630FV
Wednesday, June 23, 2010
FDA Approves Novel Early Detection HIV Test
From Medscape Medical News
Yael Waknine
June 22, 2010 — The US Food and Drug Administration (FDA) has approved, under expedited review, the first assay to detect the HIV p24 antigen as well as antibodies to HIV types 1 and 2 (Architect HIV Ag/Ab Combo Assay; Abbott Diagnostics), potentially allowing patients to be diagnosed days earlier than with antibody-only tests.
The p24 HIV antigen is a protein produced by the virus immediately after infection, before the emergence of antibodies. Early detection is critical for controlling viral spread — the company revealed that every 9.5 minutes, someone in the United States is infected with HIV, and 1 in every 5 of these infected individuals does not know it.
"Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life saving," said Peter Leone, MD, medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill, in a company news release. "A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors and also initiate antiretroviral treatment for early-stage infection, if appropriate."
Most tests currently used in the United States detect HIV antibodies only. Although HIV infection can be directly detected via nucleic acid testing, this method is not widely used.
"The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used," said Karen Midthun, MD, acting director of FDA's Center for Biologics Evaluation and Research in an agency news release. "It provides for more sensitive detection of recent HIV infections compared with antibody tests alone."
In a behavioral intervention study conducted by Johns Hopkins University and Abbott, 217 blood samples were collected from men who have sex with men. Using 2 different HIV RNA tests as a control, researchers found that the combination antigen/antibody assay detected nearly two thirds (61.9%; 13/21) of acute infections, whereas only 14.3% (3/21) of acute infections were identified by third-generation antibody tests.
The chemiluminescent microparticle immunoassay is indicated as an aid in the diagnosis of HIV-1/HIV-2 infection in adults, including pregnant women, and children as young as 2 years of age. The new assay will run on the company's automated Architect ci8200 system and is expected to be available later this year.
The FDA notes that although the HIV antigen/antibody assay is not intended for routine screening of blood donors, it may be used in urgent situations when licensed blood donor screening tests are unavailable or impractical.
The combination test previously was approved for European use in 2004, with HIV antigen-antibody combination testing being routine in European public health settings and indicated for first-line use in the United Kingdom.
Yael Waknine
June 22, 2010 — The US Food and Drug Administration (FDA) has approved, under expedited review, the first assay to detect the HIV p24 antigen as well as antibodies to HIV types 1 and 2 (Architect HIV Ag/Ab Combo Assay; Abbott Diagnostics), potentially allowing patients to be diagnosed days earlier than with antibody-only tests.
The p24 HIV antigen is a protein produced by the virus immediately after infection, before the emergence of antibodies. Early detection is critical for controlling viral spread — the company revealed that every 9.5 minutes, someone in the United States is infected with HIV, and 1 in every 5 of these infected individuals does not know it.
"Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life saving," said Peter Leone, MD, medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill, in a company news release. "A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors and also initiate antiretroviral treatment for early-stage infection, if appropriate."
Most tests currently used in the United States detect HIV antibodies only. Although HIV infection can be directly detected via nucleic acid testing, this method is not widely used.
"The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used," said Karen Midthun, MD, acting director of FDA's Center for Biologics Evaluation and Research in an agency news release. "It provides for more sensitive detection of recent HIV infections compared with antibody tests alone."
In a behavioral intervention study conducted by Johns Hopkins University and Abbott, 217 blood samples were collected from men who have sex with men. Using 2 different HIV RNA tests as a control, researchers found that the combination antigen/antibody assay detected nearly two thirds (61.9%; 13/21) of acute infections, whereas only 14.3% (3/21) of acute infections were identified by third-generation antibody tests.
The chemiluminescent microparticle immunoassay is indicated as an aid in the diagnosis of HIV-1/HIV-2 infection in adults, including pregnant women, and children as young as 2 years of age. The new assay will run on the company's automated Architect ci8200 system and is expected to be available later this year.
The FDA notes that although the HIV antigen/antibody assay is not intended for routine screening of blood donors, it may be used in urgent situations when licensed blood donor screening tests are unavailable or impractical.
The combination test previously was approved for European use in 2004, with HIV antigen-antibody combination testing being routine in European public health settings and indicated for first-line use in the United Kingdom.
Tai Chi Boosts Efficacy of Antidepressant Therapy in Older Adults
From Medscape Medical News
Fran Lowry
June 21, 2010 (Boca Raton, Florida) — Adding an abbreviated version of Tai Chi to antidepressant therapy with escitalopram improved resilience, quality of life, and cognitive function in adults with major depression 60 years and older, according to new research presented here at the New Clinical Drug Evaluation Unit (NCDEU) 50th Anniversary Meeting.
"Fewer than half of elderly depressed patients respond to first-line antidepressant pharmacotherapy," Helen Lavretsky, MD, from the David Geffen School of Medicine at the University of California, Los Angeles, said in her poster presentation here. "There is some information in the literature about the benefits of tai chi in older adults, but this relates to their balance and their physical functioning. We wanted to see whether tai chi would be helpful in improving depression."
The study recruited 112 adults with major depression and treated them with 10 mg of escitalopram daily for 6 weeks. The 70 subjects who partially responded to escitalopram continued to receive 10 mg of escitalopram per day. In addition, they were randomly assigned to receive either 10 weeks of tai chi chih for 2 hours a week or to a lecture on health education for 2 hours a week.
"Tai chi chih is a shortened form of tai chi that has only 20 movements and is easier to remember over the course of 10 weeks," Dr. Lavretsky explained.
Most of the patients (62%) were women, and their mean age was 70 years.
The patients were evaluated for depression, anxiety, resilience, health-related quality of life, psychomotor speed, and cognition.
Both tai chi and health education patients showed similar improvement in the severity of depression, with mean Hamilton Rating Scale for Depression scores of 6.0 in both groups, Dr. Lavretsky reported. However, subjects in the tai chi group showed significantly greater improvement in resilience than did subjects in the health education group (70.2% vs 65.0%; P < .05).
The tai chi group also had better health-related quality of life, with mean well-being scale scores of 80 on the 36-Item Short Form Health Survey vs 66 for the health education group (P < .05), and measures of executive cognitive function, as shown by Stroop mean error scores of 0.03 vs 0.4 errors in the health education group (P < .05).
"Patients who were in the Tai Chi arm had a greater resilience to stress, and I thought the improvement in cognitive measures, such as memory and executive function measures, with tai chi was particularly impressive," Dr. Lavretsky said in an interview.
"I'm in Los Angeles, so people tend to like alternative medicine interventions," she added. "The limiting measure was the degree of arthritis that patients had. The patients who were in the education group liked that intervention, too, but it was very interesting to me to see that this gentle form of exercise had these superior results. Even C-reactive protein levels in the tai chi group were improved."
Commenting on this poster for Medscape Medical News, Craig Nelson, MD, division chief of the Department of Geriatric Medicine at University of California, San Francisco, noted, "The interesting thing about this study was that it showed that the effect of tai chi was greater than that of the education program. That is impressive, because older depressed patients tend to have more of a benefit from a group effect, which an educational program would provide."
He suggested that tai chi may be different in its effects than other exercise. "Looking at such a comparison might be the subject of another study," he said.
This study was funded by the National Center for Complementary and Alternative Medicine. Dr. Lavretsky and Dr. Nelson have disclosed no relevant financial relationships.
New Clinical Drug Evaluation Unit (NCDEU) 50th Anniversary Meeting: Abstract 5, Session II. Presented June 16, 2010.
Fran Lowry
June 21, 2010 (Boca Raton, Florida) — Adding an abbreviated version of Tai Chi to antidepressant therapy with escitalopram improved resilience, quality of life, and cognitive function in adults with major depression 60 years and older, according to new research presented here at the New Clinical Drug Evaluation Unit (NCDEU) 50th Anniversary Meeting.
"Fewer than half of elderly depressed patients respond to first-line antidepressant pharmacotherapy," Helen Lavretsky, MD, from the David Geffen School of Medicine at the University of California, Los Angeles, said in her poster presentation here. "There is some information in the literature about the benefits of tai chi in older adults, but this relates to their balance and their physical functioning. We wanted to see whether tai chi would be helpful in improving depression."
The study recruited 112 adults with major depression and treated them with 10 mg of escitalopram daily for 6 weeks. The 70 subjects who partially responded to escitalopram continued to receive 10 mg of escitalopram per day. In addition, they were randomly assigned to receive either 10 weeks of tai chi chih for 2 hours a week or to a lecture on health education for 2 hours a week.
"Tai chi chih is a shortened form of tai chi that has only 20 movements and is easier to remember over the course of 10 weeks," Dr. Lavretsky explained.
Most of the patients (62%) were women, and their mean age was 70 years.
The patients were evaluated for depression, anxiety, resilience, health-related quality of life, psychomotor speed, and cognition.
Both tai chi and health education patients showed similar improvement in the severity of depression, with mean Hamilton Rating Scale for Depression scores of 6.0 in both groups, Dr. Lavretsky reported. However, subjects in the tai chi group showed significantly greater improvement in resilience than did subjects in the health education group (70.2% vs 65.0%; P < .05).
The tai chi group also had better health-related quality of life, with mean well-being scale scores of 80 on the 36-Item Short Form Health Survey vs 66 for the health education group (P < .05), and measures of executive cognitive function, as shown by Stroop mean error scores of 0.03 vs 0.4 errors in the health education group (P < .05).
"Patients who were in the Tai Chi arm had a greater resilience to stress, and I thought the improvement in cognitive measures, such as memory and executive function measures, with tai chi was particularly impressive," Dr. Lavretsky said in an interview.
"I'm in Los Angeles, so people tend to like alternative medicine interventions," she added. "The limiting measure was the degree of arthritis that patients had. The patients who were in the education group liked that intervention, too, but it was very interesting to me to see that this gentle form of exercise had these superior results. Even C-reactive protein levels in the tai chi group were improved."
Commenting on this poster for Medscape Medical News, Craig Nelson, MD, division chief of the Department of Geriatric Medicine at University of California, San Francisco, noted, "The interesting thing about this study was that it showed that the effect of tai chi was greater than that of the education program. That is impressive, because older depressed patients tend to have more of a benefit from a group effect, which an educational program would provide."
He suggested that tai chi may be different in its effects than other exercise. "Looking at such a comparison might be the subject of another study," he said.
This study was funded by the National Center for Complementary and Alternative Medicine. Dr. Lavretsky and Dr. Nelson have disclosed no relevant financial relationships.
New Clinical Drug Evaluation Unit (NCDEU) 50th Anniversary Meeting: Abstract 5, Session II. Presented June 16, 2010.
Experts Targeting Smoking and Secondhand Smoke Worldwide
From Heartwire
Michael O'Riordan
June 21, 2010 (Beijing, China) — Smoking, particularly the effects of secondhand smoke in nonsmokers, took center stage at the World Congress of Cardiology (WCC) 2010 last week, with experts calling on cardiologists to play a pivotal role in getting their patients to quit smoking and to reduce smoking in their communities.
"As a cardiologist who actively sees patients, one of the most important things I can do is tell them to stop smoking," Dr Sidney Smith (University of North Carolina, Chapel Hill) told the media during the WCC meeting last week. "It is arguably the major risk factor in the world right now, and if you wanted to do something to really make things better on this planet, you'd get rid of smoking and tobacco use."
Smith, the president-elect and chair of the World Heart Federation scientific advisory board, said the new National Institutes of Health (NIH) cardiovascular risk-reduction guidelines, of which he is a chair, will stress the importance of smoking cessation. "I want to be very clear where I stand on the importance of smoking cessation and tobacco use and the danger not only to the person who is smoking; [there is] also a very important risk in secondhand smoke."
If you wanted to do something to really make things better on this planet, you'd get rid of smoking and tobacco use.
An estimated 20% of cardiovascular disease worldwide is caused by tobacco, and yet, surprisingly, not everybody is aware of the link between cardiovascular disease, smoking, and secondhand smoke. In China, for example, just 4% of smokers are aware that smoking causes heart disease, said Smith.
And yet there is no shortage of scientific evidence. At the meeting, Dr Lynn Goldman (Johns Hopkins Bloomberg School of Public Health, Baltimore, MD), presented data from the recently published Institute of Medicine (IOM) report that reviewed 11 studies looking at smoking bans in different regions and countries and showed that the bans were associated with consistently observed reductions in the risk of MI [1]. The benefit was observed early, often within a year of the ban being implemented.
"We concluded on the basis of the available literature that there is a causal relationship between smoking bans and decreases in acute coronary events," said Goldman during a WCC session on smoking and acute coronary event risk. "And I should say that this is a very high standard of evidence that the Institute of Medicine uses to actually say that a relationship is causal, and for us to have developed a consensus along that line, we really have very little doubt that there is an enormous benefit [to the bans]."
Banned From Smoking in Your Own Home
An essay in the June 17, 2010 issue of the New England Journal of Medicine suggests that smoke-free policies should extend to low-income public housing in the US, making it illegal for individuals living in these dwellings to smoke even in their own homes. [2]
Smoking bans in these multiunit apartments raises ethical concerns, according to authors Drs Jonathan Winickoff (Harvard Medical School, Boston, MA), Mark Gottlieb (Northeastern University School of Law, Boston), and Michelle Mello (Harvard School of Public Health, Boston), but is justified given harm caused by exposure to tobacco, the lack of other avenues of legal redress for nonsmoking residents of public housing, and the slow pace at which no-smoking policies have been implemented in public housing.
"The same legal, practical, and health issues that have driven successful efforts to make workplaces, private vehicles, and private housing smoke-free militate in favor of extending similar protection to the vulnerable public-housing population," write the authors.
Smoking and Heart Disease Enormous Burdens in Asia
Throughout the WCC conference, numerous sessions highlighted the impact of smoking and secondhand smoke on the global risk of cardiovascular disease. Dr Judith MacKay (University of Hong Kong), a policy advisor to the World Health Organization (WHO), stressed that coronary heart disease is an enormous burden in Asia, particularly in China. As documented throughout the meeting, there has been a large shift in the occurrence of cardiovascular disease in the past 50 years, with approximately 60% of the burden lying in low- and middle-income countries. In China alone, estimates suggest that more than three million people die annually from cardiovascular disease.
In even scarier news, MacKay noted that health professionals, despite knowing better, continue to smoke themselves. In China, home to one-third of the world's smokers, 30% of cardiologists smoke, while nearly 25% of individuals worldwide who are training to be a health professional, such as those in medical and nursing schools, also continue to smoke. "Our objectives are very simple," MacKay told the media. "It is to raise public and cardiologists' awareness of the connection between secondhand smoke and heart disease."
Those objectives are part of the efforts of several organizations, including the World Heart Federation, the Centers for Disease Control and Prevention (CDC), the World Lung Foundation, and Roswell Park Cancer Institute, to raise awareness about the cardiovascular risks of smoking and secondhand smoke. The group recently launched a campaign, one that includes the creation of a DVD--Warning: Secondhand Smoke is Hazardous to your Heart--exploring the link between cardiovascular problems and secondhand-smoke exposure. The new report includes many of the studies reported previously by heartwire and highlights a 2009 meta-analysis showing a 17% reduction in acute MI following the implementation of smoke-free laws.
Despite the sobering statistics, there was some good news presented at the WCC meeting. Dr David Wong (University of Hong Kong) presented data showing that the introduction of smoke-free legislation in Hong Kong led to a 28% spike in calls to a youth hotline set up to help adolescents quit smoking, as well as a 28% increase in the number of people who came in for counseling to quit. The data showed, however, that hitting teenagers in the pocketbook is the best way to compel them to quit smoking. After a significant 50% tax hike in 2009 on the cost of cigarettes, the number of calls to the "Youth Quitline" increased 144%, while 111% more teenagers came in for counseling to quit smoking.
The Need for Enforcement and Better Compliance
Most vital, however, in the global campaign against smoking is article 8 of the WHO Framework Convention on Tobacco Control (FCTC), which "commits governments to protecting their citizens from exposure to secondhand smoke in indoor public places and workplaces and public transport." The FCTC came into effect in 2005 and now has 169 parties that cover more than 80% of the world's population.
Presenting during a WCC session on the need to enhance the impact of smoke-free policies to reduce cardiovascular disease, Dr Armando Peruga (World Health Organization) pointed out that 43% of teenagers 13 years old to 15 years old are still living at home with smokers. Europe is the worst offender in this regard, said Peruga, with nearly 78% of 13- to 15-year-olds living at home with a smoker, while 51% of kids in Asia lived with a smoker.
During his presentation, Peruga noted that while 169 countries are parties to article 8, just 17 countries had policies in 2008 that provided universal, comprehensive, and effective protection from secondhand smoke, and only 5% of the population lives in a country with comprehensive, 100% smoke-free policies. The "gold-standard" smoke-free law, one where smoking is prohibited in all enclosed public places and workplaces, including bars, restaurants, and public transport, is rare, he noted, with compliance varying by sector. Hospitals and public transportation tend to most stringently adhere to the smoke-free policy, while bars and restaurants tend be more lax.
"Compliance is still an issue, and as we have been saying, passing a law, even a good law, a comprehensive law, is not enough," said Peruga. "We have always pointed out that enforcement requires small but critical resources. Anyone who forgets this is doomed to have these types of results, with relatively good laws on the books, but with low compliance."
Michael O'Riordan
June 21, 2010 (Beijing, China) — Smoking, particularly the effects of secondhand smoke in nonsmokers, took center stage at the World Congress of Cardiology (WCC) 2010 last week, with experts calling on cardiologists to play a pivotal role in getting their patients to quit smoking and to reduce smoking in their communities.
"As a cardiologist who actively sees patients, one of the most important things I can do is tell them to stop smoking," Dr Sidney Smith (University of North Carolina, Chapel Hill) told the media during the WCC meeting last week. "It is arguably the major risk factor in the world right now, and if you wanted to do something to really make things better on this planet, you'd get rid of smoking and tobacco use."
Smith, the president-elect and chair of the World Heart Federation scientific advisory board, said the new National Institutes of Health (NIH) cardiovascular risk-reduction guidelines, of which he is a chair, will stress the importance of smoking cessation. "I want to be very clear where I stand on the importance of smoking cessation and tobacco use and the danger not only to the person who is smoking; [there is] also a very important risk in secondhand smoke."
If you wanted to do something to really make things better on this planet, you'd get rid of smoking and tobacco use.
An estimated 20% of cardiovascular disease worldwide is caused by tobacco, and yet, surprisingly, not everybody is aware of the link between cardiovascular disease, smoking, and secondhand smoke. In China, for example, just 4% of smokers are aware that smoking causes heart disease, said Smith.
And yet there is no shortage of scientific evidence. At the meeting, Dr Lynn Goldman (Johns Hopkins Bloomberg School of Public Health, Baltimore, MD), presented data from the recently published Institute of Medicine (IOM) report that reviewed 11 studies looking at smoking bans in different regions and countries and showed that the bans were associated with consistently observed reductions in the risk of MI [1]. The benefit was observed early, often within a year of the ban being implemented.
"We concluded on the basis of the available literature that there is a causal relationship between smoking bans and decreases in acute coronary events," said Goldman during a WCC session on smoking and acute coronary event risk. "And I should say that this is a very high standard of evidence that the Institute of Medicine uses to actually say that a relationship is causal, and for us to have developed a consensus along that line, we really have very little doubt that there is an enormous benefit [to the bans]."
Banned From Smoking in Your Own Home
An essay in the June 17, 2010 issue of the New England Journal of Medicine suggests that smoke-free policies should extend to low-income public housing in the US, making it illegal for individuals living in these dwellings to smoke even in their own homes. [2]
Smoking bans in these multiunit apartments raises ethical concerns, according to authors Drs Jonathan Winickoff (Harvard Medical School, Boston, MA), Mark Gottlieb (Northeastern University School of Law, Boston), and Michelle Mello (Harvard School of Public Health, Boston), but is justified given harm caused by exposure to tobacco, the lack of other avenues of legal redress for nonsmoking residents of public housing, and the slow pace at which no-smoking policies have been implemented in public housing.
"The same legal, practical, and health issues that have driven successful efforts to make workplaces, private vehicles, and private housing smoke-free militate in favor of extending similar protection to the vulnerable public-housing population," write the authors.
Smoking and Heart Disease Enormous Burdens in Asia
Throughout the WCC conference, numerous sessions highlighted the impact of smoking and secondhand smoke on the global risk of cardiovascular disease. Dr Judith MacKay (University of Hong Kong), a policy advisor to the World Health Organization (WHO), stressed that coronary heart disease is an enormous burden in Asia, particularly in China. As documented throughout the meeting, there has been a large shift in the occurrence of cardiovascular disease in the past 50 years, with approximately 60% of the burden lying in low- and middle-income countries. In China alone, estimates suggest that more than three million people die annually from cardiovascular disease.
In even scarier news, MacKay noted that health professionals, despite knowing better, continue to smoke themselves. In China, home to one-third of the world's smokers, 30% of cardiologists smoke, while nearly 25% of individuals worldwide who are training to be a health professional, such as those in medical and nursing schools, also continue to smoke. "Our objectives are very simple," MacKay told the media. "It is to raise public and cardiologists' awareness of the connection between secondhand smoke and heart disease."
Those objectives are part of the efforts of several organizations, including the World Heart Federation, the Centers for Disease Control and Prevention (CDC), the World Lung Foundation, and Roswell Park Cancer Institute, to raise awareness about the cardiovascular risks of smoking and secondhand smoke. The group recently launched a campaign, one that includes the creation of a DVD--Warning: Secondhand Smoke is Hazardous to your Heart--exploring the link between cardiovascular problems and secondhand-smoke exposure. The new report includes many of the studies reported previously by heartwire and highlights a 2009 meta-analysis showing a 17% reduction in acute MI following the implementation of smoke-free laws.
Despite the sobering statistics, there was some good news presented at the WCC meeting. Dr David Wong (University of Hong Kong) presented data showing that the introduction of smoke-free legislation in Hong Kong led to a 28% spike in calls to a youth hotline set up to help adolescents quit smoking, as well as a 28% increase in the number of people who came in for counseling to quit. The data showed, however, that hitting teenagers in the pocketbook is the best way to compel them to quit smoking. After a significant 50% tax hike in 2009 on the cost of cigarettes, the number of calls to the "Youth Quitline" increased 144%, while 111% more teenagers came in for counseling to quit smoking.
The Need for Enforcement and Better Compliance
Most vital, however, in the global campaign against smoking is article 8 of the WHO Framework Convention on Tobacco Control (FCTC), which "commits governments to protecting their citizens from exposure to secondhand smoke in indoor public places and workplaces and public transport." The FCTC came into effect in 2005 and now has 169 parties that cover more than 80% of the world's population.
Presenting during a WCC session on the need to enhance the impact of smoke-free policies to reduce cardiovascular disease, Dr Armando Peruga (World Health Organization) pointed out that 43% of teenagers 13 years old to 15 years old are still living at home with smokers. Europe is the worst offender in this regard, said Peruga, with nearly 78% of 13- to 15-year-olds living at home with a smoker, while 51% of kids in Asia lived with a smoker.
During his presentation, Peruga noted that while 169 countries are parties to article 8, just 17 countries had policies in 2008 that provided universal, comprehensive, and effective protection from secondhand smoke, and only 5% of the population lives in a country with comprehensive, 100% smoke-free policies. The "gold-standard" smoke-free law, one where smoking is prohibited in all enclosed public places and workplaces, including bars, restaurants, and public transport, is rare, he noted, with compliance varying by sector. Hospitals and public transportation tend to most stringently adhere to the smoke-free policy, while bars and restaurants tend be more lax.
"Compliance is still an issue, and as we have been saying, passing a law, even a good law, a comprehensive law, is not enough," said Peruga. "We have always pointed out that enforcement requires small but critical resources. Anyone who forgets this is doomed to have these types of results, with relatively good laws on the books, but with low compliance."
Tuesday, June 22, 2010
Modest Tea and Coffee Consumption Cuts CHD Risk
From Heartwire
Lisa Nainggolan
June 18, 2010 (Utrecht, the Netherlands) — The latest look at the effects of tea and coffee consumption on cardiovascular morbidity and mortality suggests that moderate intake of either reduces coronary heart disease risk but has little effect on stroke and no effect on all-cause mortality [1]. Tea, however, does seem to reduce CHD deaths.
Dr J Margot de Koning Gans (University Medical Center, Utrecht, the Netherlands) and colleagues prospectively studied more than 35 000 participants in the Dutch portion of the EPIC study, EPIC-NL. They report their findings online June 18, 2010 in Arteriosclerosis, Thrombosis, and Vascular Biology.
Coauthor Dr Yvonne T van der Schouw (University Medical Center) told heartwire the relationship between CHD morbidity and coffee was U-shaped: "We saw a significant protective effect with around two to four cups of coffee a day," whereas for tea, it was a linear and inverse association, with the lowest hazard ratio seen for more than six cups a day. But three to six cups of tea a day was associated with an almost 50% reduction in CHD deaths, although the number of events was small.
She stressed, however, that the findings are applicable only to filter coffee prepared as it is in the Netherlands and primarily to black tea, which is the type of tea consumed by around 80% of Dutch people. And she warned that the results do not indicate that people who have never drunk coffee or tea should start to do so, "because that is not what we studied."
No Association Between Coffee and Tea Intake and Stroke
The Dutch researchers assessed tea and coffee consumption with a validated food-frequency questionnaire and observed the 37 514 participants for 13 years for the occurrence of CVD morbidity and mortality.
For CHD, the lowest hazard ratio was seen for 2.1 to 3.0 cups of coffee per day (0.79; p=0.01) and for tea this was observed for more than six cups per day (0.64; p=0.02). No associations between coffee or tea and stroke were found.
Tea consumption did significantly reduce CHD mortality, however, with a hazard ratio of 0.55 (p=0.03) for 3.1 to 6.0 cups per day. Coffee also reduced CHD mortality, but the effect was not significant. Neither beverage had an effect on all-cause death.
Discussing possible mechanisms for these observed effects, the investigators point out that coffee contains several biologically active substances that could increase CVD risk by increasing cholesterol and decreasing insulin sensitivity, but it also contains other compounds with antioxidant properties that could reduce risk. Tea contains flavonoids, which are antioxidant, but the underlying mechanisms of their effects are still not entirely clear, they note.
They also mention some limitations of their study. Relatively few patients died of CHD or stroke, so there was limited power to detect associations for these end points. Also, they relied on self-reported data on tea and coffee intake.
Evidence Strengthened on Lower CHD Risk With Tea and Coffee
Previous studies have also shown U-shaped association between coffee consumption and CHD morbidity, the investigators note, and modest benefits on CV mortality. Taken together with this study, the findings overall "suggest a modest risk reduction of CV mortality with moderate coffee consumption," they state.
For tea, only prior studies in continental Europe have suggested a decrease in the rate of CHD with increasing tea consumption, and most previous research on tea intake and CHD mortality has been in specific subgroups, such as hypertensive or postmenopausal subjects, they note.
In conclusion, they say, "With this large prospective study, we showed that tea consumption was associated with a reduced risk of CHD mortality. We strengthen the evidence on the lower risk of CHD associated with coffee and tea consumption; however neither . . . was associated with the risk of stroke or all-cause mortality."
The authors declare that they have no conflicts of interest.
Lisa Nainggolan
June 18, 2010 (Utrecht, the Netherlands) — The latest look at the effects of tea and coffee consumption on cardiovascular morbidity and mortality suggests that moderate intake of either reduces coronary heart disease risk but has little effect on stroke and no effect on all-cause mortality [1]. Tea, however, does seem to reduce CHD deaths.
Dr J Margot de Koning Gans (University Medical Center, Utrecht, the Netherlands) and colleagues prospectively studied more than 35 000 participants in the Dutch portion of the EPIC study, EPIC-NL. They report their findings online June 18, 2010 in Arteriosclerosis, Thrombosis, and Vascular Biology.
Coauthor Dr Yvonne T van der Schouw (University Medical Center) told heartwire the relationship between CHD morbidity and coffee was U-shaped: "We saw a significant protective effect with around two to four cups of coffee a day," whereas for tea, it was a linear and inverse association, with the lowest hazard ratio seen for more than six cups a day. But three to six cups of tea a day was associated with an almost 50% reduction in CHD deaths, although the number of events was small.
She stressed, however, that the findings are applicable only to filter coffee prepared as it is in the Netherlands and primarily to black tea, which is the type of tea consumed by around 80% of Dutch people. And she warned that the results do not indicate that people who have never drunk coffee or tea should start to do so, "because that is not what we studied."
No Association Between Coffee and Tea Intake and Stroke
The Dutch researchers assessed tea and coffee consumption with a validated food-frequency questionnaire and observed the 37 514 participants for 13 years for the occurrence of CVD morbidity and mortality.
For CHD, the lowest hazard ratio was seen for 2.1 to 3.0 cups of coffee per day (0.79; p=0.01) and for tea this was observed for more than six cups per day (0.64; p=0.02). No associations between coffee or tea and stroke were found.
Tea consumption did significantly reduce CHD mortality, however, with a hazard ratio of 0.55 (p=0.03) for 3.1 to 6.0 cups per day. Coffee also reduced CHD mortality, but the effect was not significant. Neither beverage had an effect on all-cause death.
Discussing possible mechanisms for these observed effects, the investigators point out that coffee contains several biologically active substances that could increase CVD risk by increasing cholesterol and decreasing insulin sensitivity, but it also contains other compounds with antioxidant properties that could reduce risk. Tea contains flavonoids, which are antioxidant, but the underlying mechanisms of their effects are still not entirely clear, they note.
They also mention some limitations of their study. Relatively few patients died of CHD or stroke, so there was limited power to detect associations for these end points. Also, they relied on self-reported data on tea and coffee intake.
Evidence Strengthened on Lower CHD Risk With Tea and Coffee
Previous studies have also shown U-shaped association between coffee consumption and CHD morbidity, the investigators note, and modest benefits on CV mortality. Taken together with this study, the findings overall "suggest a modest risk reduction of CV mortality with moderate coffee consumption," they state.
For tea, only prior studies in continental Europe have suggested a decrease in the rate of CHD with increasing tea consumption, and most previous research on tea intake and CHD mortality has been in specific subgroups, such as hypertensive or postmenopausal subjects, they note.
In conclusion, they say, "With this large prospective study, we showed that tea consumption was associated with a reduced risk of CHD mortality. We strengthen the evidence on the lower risk of CHD associated with coffee and tea consumption; however neither . . . was associated with the risk of stroke or all-cause mortality."
The authors declare that they have no conflicts of interest.
Saturday, June 12, 2010
New Brain Death Guidelines Issued
From Medscape Medical News
Allison Gandey
June 10, 2010 — The American Academy of Neurology has released new guidelines for determining brain death in adults. Updated for the first time in 15 years, the recommendations provide step-by-step instructions to help guide clinical decision making.
"The brain death diagnosis can be made only after a comprehensive clinical evaluation and often involves more than 25 separate assessments," lead author Eelco Wijdicks, MD, from the Mayo Clinic in Rochester, Minnesota, said in a news release.
The guidelines are published in the June 8 issue of Neurology.
The authors report that new data have confirmed the effectiveness of earlier recommendations. They saw no evidence of recovery of neurologic function after a diagnosis of brain death using the criteria from the 1995 practice parameter.
Checklist for determining brain death.
"To correctly diagnose brain death, it is essential clinicians adhere to a uniform framework," coauthor Gary Gronseth, MD, from the University of Kansas, Kansas City, said in an interview.
"We wanted to provide useful tools to help clinicians," Dr. Gronseth said, "but many factors will still need to be based on clinical judgment."
The authors report insufficient evidence to determine the minimally acceptable observation period to ensure that neurologic functions have ceased irreversibly.
"I think some people will be disappointed that we weren't able to nail this down," Dr. Gronseth said, "but this will be highly variable patient to patient, and there is no general rule."
These new guidelines focus on patients 18 years and older. Another group is currently working on new brain death recommendations for children. Those recommendations are expected to be released in a couple of months. Some predict those guidelines will include a prescribed observation period.
"Different groups take different approaches," Dr. Gronseth noted. "We felt the evidence was lacking."
Single Exam Sufficient
Some clinicians may also be surprised to see that more than 1 exam is not required in the new brain death guidelines. "The original guideline did not require this either, but I think it was a common misconception that 2 exams are necessary. This is not the case," Dr. Gronseth said. "Some people may object, but we found that 1 exam was sufficient."
The authors point out that complex-spontaneous motor movements and false-positive triggering of the ventilator may occur in patients who are brain dead.
Oxygenation diffusion to determine apnea is safe, they report, but there is insufficient evidence to determine the comparative benefit of the various techniques used for apnea testing.
There is also insufficient evidence to determine whether newer ancillary tests accurately confirm the cessation of function of the entire brain.
To correctly diagnose brain death, it is essential clinicians adhere to a uniform framework.
Asked by Medscape Neurology to comment on the new guidelines, James Bernat, MD, from Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, said he hopes these recommendations will help address the often wide variation among hospitals.
In 2008, guideline senior author David Greer, MD, from Massachusetts General Hospital, in Boston, reported substantial differences in approaches to brain death among leading neurological institutions in the United States.
That study, published in Neurology, prompted this guideline update because the authors felt more detail was needed to help physicians (2008;70;284-289).
"The new recommendations are encouraging uniformity and thoroughness among institutions," Dr. Bernat said.
"Moving forward, I'd like to see a national registry to track brain death, so we can get an idea of how we're doing," Dr. Gronseth said. "This registry should be voluntary. A lot of studies are done this way."
The American Academy of Neurology will be hosting an online conference about the new guidelines Monday, June 21. The authors will present at the session and take questions. The registration deadline for continuing medical education credit is June 16. Clinicians wanting to participate will need a computer with Microsoft Office Powerpoint and a telephone. For more information and to access the audio conference, visit the academy's Web site.
Neurology. 2010;74:1911-1918. Abstract
Allison Gandey
June 10, 2010 — The American Academy of Neurology has released new guidelines for determining brain death in adults. Updated for the first time in 15 years, the recommendations provide step-by-step instructions to help guide clinical decision making.
"The brain death diagnosis can be made only after a comprehensive clinical evaluation and often involves more than 25 separate assessments," lead author Eelco Wijdicks, MD, from the Mayo Clinic in Rochester, Minnesota, said in a news release.
The guidelines are published in the June 8 issue of Neurology.
The authors report that new data have confirmed the effectiveness of earlier recommendations. They saw no evidence of recovery of neurologic function after a diagnosis of brain death using the criteria from the 1995 practice parameter.
Checklist for determining brain death.
"To correctly diagnose brain death, it is essential clinicians adhere to a uniform framework," coauthor Gary Gronseth, MD, from the University of Kansas, Kansas City, said in an interview.
"We wanted to provide useful tools to help clinicians," Dr. Gronseth said, "but many factors will still need to be based on clinical judgment."
The authors report insufficient evidence to determine the minimally acceptable observation period to ensure that neurologic functions have ceased irreversibly.
"I think some people will be disappointed that we weren't able to nail this down," Dr. Gronseth said, "but this will be highly variable patient to patient, and there is no general rule."
These new guidelines focus on patients 18 years and older. Another group is currently working on new brain death recommendations for children. Those recommendations are expected to be released in a couple of months. Some predict those guidelines will include a prescribed observation period.
"Different groups take different approaches," Dr. Gronseth noted. "We felt the evidence was lacking."
Single Exam Sufficient
Some clinicians may also be surprised to see that more than 1 exam is not required in the new brain death guidelines. "The original guideline did not require this either, but I think it was a common misconception that 2 exams are necessary. This is not the case," Dr. Gronseth said. "Some people may object, but we found that 1 exam was sufficient."
The authors point out that complex-spontaneous motor movements and false-positive triggering of the ventilator may occur in patients who are brain dead.
Oxygenation diffusion to determine apnea is safe, they report, but there is insufficient evidence to determine the comparative benefit of the various techniques used for apnea testing.
There is also insufficient evidence to determine whether newer ancillary tests accurately confirm the cessation of function of the entire brain.
To correctly diagnose brain death, it is essential clinicians adhere to a uniform framework.
Asked by Medscape Neurology to comment on the new guidelines, James Bernat, MD, from Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, said he hopes these recommendations will help address the often wide variation among hospitals.
In 2008, guideline senior author David Greer, MD, from Massachusetts General Hospital, in Boston, reported substantial differences in approaches to brain death among leading neurological institutions in the United States.
That study, published in Neurology, prompted this guideline update because the authors felt more detail was needed to help physicians (2008;70;284-289).
"The new recommendations are encouraging uniformity and thoroughness among institutions," Dr. Bernat said.
"Moving forward, I'd like to see a national registry to track brain death, so we can get an idea of how we're doing," Dr. Gronseth said. "This registry should be voluntary. A lot of studies are done this way."
The American Academy of Neurology will be hosting an online conference about the new guidelines Monday, June 21. The authors will present at the session and take questions. The registration deadline for continuing medical education credit is June 16. Clinicians wanting to participate will need a computer with Microsoft Office Powerpoint and a telephone. For more information and to access the audio conference, visit the academy's Web site.
Neurology. 2010;74:1911-1918. Abstract
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