In the News for the Week of 9-11-07
- Teen suicides increased after black-box warnings
- Work-hour limits have little effect on mortality
- Doctors' communication skills predict patient complaints
- Epoetin alfa may decrease mortality rates in trauma patients, study finds
- Nitrofurazone-impregnated catheters improve rates of catheter-associated infection
- ACP Journal Club: Risks and benefits of screening mammography for women age 40 to 49
- Stopping statin therapy after stroke increases mortality, study finds
- Second-generation smallpox vaccine approved
Flu season update
- HHS to award $75 million to states for pandemic flu preparedness
- ACP alerts CMS to problems with the Physician Fee Schedule
- Master to receive rheumatology gold award
- Read the latest ACP Observer online
- Cartoon caption contest: Put words in our mouth
Teen suicides increased after black-box warnings
Teen suicides increased dramatically between 2003 and 2004, according to new statistics from the CDC, and a study released last week suggests an association between the increase and black box warnings on selective serotonin reuptake inhibitors (SSRIs).
The suicide rate for 10- to 24-year-olds increased by 8% from 2003 to 2004, according to a report published in the CDC’s Morbidity and Mortality Weekly Report. The increase was the largest in 15 years, and followed a 28% decline from 1990 to 2003. The greatest percentage increase was among 10- to 14-year-old females, followed by 15- to 19-year old females and 15- to 19-year-old males.
CDC officials did not suggest a cause for the increase in suicides, but a study published in the September American Journal of Psychiatry points to the public health warnings issued about SSRIs. The researchers examined U.S. and Dutch data on SSRI prescriptions for adolescents from 2003 to 2005 and found 22% reductions in both countries after the warnings. The study authors concluded that these decreases in prescriptions were associated with increases in teenage suicides that were recorded in the U.S. and the Netherlands.
An accompanying editorial noted that further historical research would solidify the study authors’ assertion, if it could be shown that increasing SSRI prescriptions were linked to lower rates of suicide. The editorial writers called the study compelling, but concluded that the costs and benefits of SSRIs vary with patients’ age and indication. Clinicians should provide patients and their families with the data necessary to make an informed evaluation of the benefits and risks of medication versus no treatment, the editorial said.
The CDC report is online.
Resident work-hour limits have had little impact on patient mortality rates, according to two new studies which compared patient outcomes before and after caps were instituted.
The first observational study tracked Medicare patients admitted to the U.S.’s 3,321 nonfederal, acute care hospitals between 2000 and 2005. The studied patients had principal diagnoses of acute myocardial infarction (AMI), congestive heart failure, gastrointestinal bleeding, stroke or a surgical-related diagnosis. Comparing more versus less teaching-intensive hospitals, the study found no significant relative increases or decreases in the odds of patient mortality within 30 days of admission. The study authors concluded that, at least in the first two years of implementation, duty-hour reform was not associated with either significant worsening or improvement in mortality for Medicare patients.
In the second study, the same authors compared outcomes in patients with the same diagnoses who were admitted to Veterans Administration hospitals between 2000 and 2005. Although the study found no significant difference in mortality for surgical patients, medical patients in the more teaching-intensive hospitals had improved mortality after the work-hour change. The improvement was greatest for patients who were diagnosed with AMI. The studies were published in the Sept. 5 Journal of the American Medical Association.
There are many factors other than the duty-hour change that could have affected the mortality of VA medical patients, an accompanying editorial noted. Mortality of AMI patients, particularly, may have been affected by new guidelines released in 2004 which may have been implemented more rapidly in teaching-intensive hospitals. Taken together, the studies show that there is no clear evidence for an effect of duty-hour reforms on patient mortality, the editorial concluded.
Physicians who perform poorly on evaluations of their communication skills are more likely to have complaints filed against them with medical regulatory authorities, according to a new study conducted in Canada.
The cohort study followed the 3,424 physicians who took the Medical Council of Canada clinical skills examination between 1993 and 1996 and were then licensed in Ontario or Quebec. From the examination period to 2005, medical regulatory authorities received 1,116 complaints about the studied physicians and retained 696 after investigation. The research found that patient-physician communication scores from the exam were significantly predictive of retained complaints, with scores in the bottom quartile representing 9.2% of complaints. The study was published in the Sept. 7 Journal of the American Medical Association.
The results of this Canadian research may not directly translate to the U.S. Medical Licensing Exam Step 2 CS, but they do raise questions about how to deal with candidates who fail the test, noted an accompanying editorial. The study also highlights the importance of addressing communication skills early and often during medical education.
The editorial writer suggests that potential improvements include more systematically assessing interpersonal skills during admissions, connecting clerkship and residency experiences to earlier communications training, and having a communications component in clinical skills assessments.
Treatment with epoetin alfa could lead to better survival rates in patients with trauma, according to a new study.
Researchers from the EPO Critical Care Trials Group performed a randomized, double-blind placebo-controlled trial to determine whether epoetin alfa reduced the necessity of red-cell transfusion in critically ill patients. Secondary end points were mortality rate, difference in hemoglobin level from baseline and the number of red-cell units received. Between 48 and 96 hours after ICU admission, researchers randomly assigned 1,460 trauma, medical and surgical patients at 115 medical centers to receive 40,000 U of epoetin alfa or placebo weekly for up to three weeks. The study was published in the Sept. 6 New England Journal of Medicine.
Epoetin alfa had no effect on the frequency or amount of red-cell transfusion. The relative risk for transfusion was 0.95 (95% CI, 0.85 to 1.06) in the treatment group compared with the placebo group, and the two groups did not differ significantly in the units of red blood cells received. However, patients in the treatment group did have statistically significantly higher hemoglobin levels and lower mortality rates at day 29 of the study. The difference in mortality rate persisted in the treatment group at day 140, especially in trauma patients. Patients receiving epoetin alfa were significantly more likely to have a thrombotic event.
The authors concluded that epoetin alfa might be beneficial for trauma patients who remain in the ICU for more than 48 hours and have hemoglobin levels less than 12 g/dL. However, the data do not currently support this treatment for patients with ICU stays of less than 48 hours or for most nontrauma patients. Because of the higher risk for thrombotic events in the treatment group, the authors suggested that clinicians consider prescribing prophylactic heparin in critically ill patients receiving epoetin alfa.
An accompanying editorial called the study results "tantalizing but premature" and recommended further randomized trials with independent research oversight carefully examining fatal and nonfatal clinically important outcomes.
Nitrofurazone-impregnated catheters may improve rates of catheter-associated bacteriuria and funguria (CABF) in trauma patients, according to a new study.
Researchers at Copenhagen Trauma Center in Denmark randomly assigned 212 consecutive patients who needed urinary catheters on arrival to receive a nitrofurazone-impregnated or standard silicone catheter. HIV-positive patients, pregnant patients, patients with primary burn injuries, patients receiving steroids and patients who could not give informed consent were excluded. CABF was assessed daily until catheter removal. The study results were published in the Sept. 4 Annals of Internal Medicine.
During the study, researchers obtained 1,190 urine cultures over 1,001 catheter-days. CABF was less common in the nitrofurazone group than in the silicone group (9.1% vs. 24.7%). In addition, CABF took more time to develop and new or changed antimicrobial therapy was less common in the nitrofurazone group.
The study's primary outcome was asymptomatic CABF, whose clinical significance is not known, and data were missing in 27% of patients. However, the authors pointed out that asymptomatic CABF is a reasonable end point that has been used previously in the literature and that missing data were similar between the two study groups. The authors concluded that nitrofurazone-impregnated catheters led to lower rates of CABF in trauma patients and should be considered in this population. They called for a future trial to examine the effect of nitrofurazone-impregnated catheters in other patient subgroups.
Annals of Internal Medicine is online.
A new meta-analysis compared the risks and benefits of screening mammography for women age 40 to 49 and found that screening reduces risk for breast cancer mortality, chemotherapy and hormone therapy, but increases the risk for mastectomy, radiation therapy, radiation-induced breast cancer, diagnosis of ductal carcinoma in situ (DCIS) and cumulative false-positive mammograms.
The research included 117 randomized, controlled trials, meta-analyses, and cohort or observational studies that evaluated breast cancer mortality, false-positive mammograms, effects of screening mammography on treatment, or other risks in women 40 years old or older. The study authors concluded that a woman between 40 and 49 who had a lower-than-average risk for breast cancer and higher-than-average concerns about false-positives might reasonably delay screening, but that measuring risks and benefits accurately enough to identify these women remains a challenge. The study is abstracted in the September/October ACP Journal Club.
This review provides the components that women and physicians must weigh when making a decision about screening, although the decision is still a very complex one, noted Journal Club reviewers Venhat Ramachandran, MD, and Bruce E. Hillner, MD, of Virginia Commonwealth University. The study also highlighted the greatly increased risk of breast cancer faced by women in their 40s with first-degree relatives with the disease as well as raising questions about whether women with DCIS are overtreated, they said.
Peer ratings for this review: Primary Care, Oncology: 5/7 stars. IM/Ambulatory Care: 6/7 stars.
ACP Journal Club is online.
A study published in the journal Stroke concluded that stopping statin therapy within a year after surviving a stroke significantly increases a patient's risk of death.
Italian researchers followed 631 male and female stroke survivors, all with no previous evidence of coronary heart disease, for 12 months following acute ischemic stroke. Almost 39% of the patients had discontinued statin therapy within a year, and researchers found that the earlier patients discontinued therapy, the higher their risk of mortality. The study appears in the Aug. 30 issue of the American Heart Association's journal Stroke.
The majority of patients with previous ischemic stroke are expected to benefit significantly from long-term statin therapy, said the authors. However, the median time from discharge to statin discontinuation among patients in the study was just 30 days (mean time, 48.6+54.9 days). These findings highlight the need for a better transition process as a patient moves from the hospital to outpatient primary care, the authors concluded.
The Stroke abstract is online.
The FDA licensed a new smallpox vaccine, ACAM2000, to inoculate people at high risk of exposure, as well as for use during a bioterrorist attack.
ACAM2000 supplements the current supply of smallpox vaccine, making the nation more prepared should the virus ever be used as a weapon, an FDA release said. The vaccine will be included in the CDC's Strategic National Stockpile of medical supplies.
ACAM2000 is made using a live form of the smallpox-related vaccinia virus. The vaccine is derived from the only other smallpox vaccine licensed by the FDA, Dryvax, approved in 1931 and now in limited supply because it is no longer manufactured.
Although smallpox vaccination ended in the U.S. in 1972, the U.S. military resumed vaccination of at-risk personnel in 1999, after concluding that the disease posed a potential bioterrorism threat. The last case of naturally occurring smallpox in the U.S. was in 1949 and the last case in the world was reported in Somalia in 1977.
Known stockpiles of the virus are kept only in two approved labs in the U.S. and Russia. The CDC considers it a Category A agent, meaning it presents one of the greatest potential threats for harming public health.
In other FDA news, the agency approved the first generic version of carvedilol (brand name: Coreg), used to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.
A complete round-up of FDA meetings and drug approvals is in the September ACP Observer.
Flu season update
HHS announced that it will award $75 million in supplemental funding to four metropolitan areas to help strengthen their capacity to respond to a pandemic influenza outbreak.
According to an Aug. 30 HHS news release, the supplemental funding will be used to:
Establish or enhance stockpiles of critical medical equipment and supplies;
Continue development of plans for maintenance, distribution and sharing of those resources;
Plan for and develop pandemic alternate care sites; and
Conduct medical surge exercises.
The supplemental grants are in addition to the $430 million HHS announced earlier to help hospitals and other health care facilities respond to bioterror attacks, infectious diseases, and natural disasters that may cause mass casualties.
Details on the individual HHS grants are online.
More information on state and local funding allocations is online.
College representatives sent comments to CMS last week regarding the proposed Medicare Physician Fee Schedule for 2008 and other provisions for changes to the Medicare program.
In the letter, Joseph W. Stubbs, FACP, chair of ACP’s Medical Services Committee, noted that “as the specialty that provides more care to Medicare beneficiaries than any other, internal medicine is particularly affected by the proposed rule.”
Dr. Stubbs wrote that provisions in the proposed rule related to physician self-referral regulations did not strike a balance of drawing narrow exceptions to provide for legitimate purposes while excluding “bad actors” from engaging in illegitimate activity. He noted that these proposals, if finalized, would make it even more difficult for physicians to participate in legitimate business ventures and would lead to a decrease in patient access to necessary services.
In particular, Dr. Stubbs noted strong support for the in-office ancillary services exception that many physicians rely on to provide ancillary services to their patients. This exception has enabled physicians throughout the country to provide services in their offices where patients are most likely to seek them and benefit from their timely provision. ACP strongly opposes any attempt to further limit services that can be provided by a physician practice under the in-office ancillary services exception.
The full text of ACP’s comments on the rule is online.
Edward D. Harris Jr., MACP, has been selected to receive the American College of Rheumatology’s Presidential Gold Medal award. The medal, which is the highest award that the ACR bestows, will be presented during the ACR Annual Scientific Meeting, Nov. 6-11, in Boston.
Dr. Harris is the George DeForest Barnett Professor, emeritus, for the department of medicine at Stanford University School of Medicine. He also serves as the executive secretary for Alpha Omega Alpha Honor Medical Society and editor of the society’s publication, The Pharos. Dr. Harris’ scientific and clinical career has focused almost entirely on rheumatoid arthritis.
The Presidential Gold Medal is awarded in recognition of outstanding achievements in rheumatology over an entire career. Candidates for the award have made important contributions in multiple areas such as clinical medicine, research, education or administration.
The American College of Rheumatology is online.
The current issue of ACP Observer features in-depth looks at dialysis for the very elderly, mental health insurance parity and micropractices, no-frills arrangements that have let some doctors devote more time to patient care.
The September issue is online.
To introduce a new cartoon feature for ACP Observer, ObserverWeekly is inviting its readers to submit their wit. Add a caption to the image below and e-mail it to firstname.lastname@example.org by Oct. 1. Staff will select a winning caption and print it in an upcoming issue. The author of the winning quip will receive a complimentary copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history.
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Copyright 2007 by the American College of Physicians.
A 54-year-old man is evaluated during follow-up consultation regarding laboratory studies completed for a life insurance policy. He reports no symptoms. A bone marrow biopsy shows trilineage dysplasia with 1% blasts. Results of cytogenetic testing show loss of the Y chromosome (-Y). What is the most appropriate management?
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