In the News for the Week of 12-19-06
- CMS hospital ratings don’t correlate to death rates
- Longer colonoscopic withdrawal times improve adenoma detection
- Study finds flu shots more effective than inhaled vaccine
- First test to screen blood donors for Chagas disease approved
- Unapproved quinine drugs to be taken off the market
- Annals of Internal Medicine:
- Black cohosh no more effective for menopause symptoms than placebo
- Enzyme replacement slowed progression of complications from Fabry disease
- Doctors urged to accept new TRICARE patients
- ACP publishes FAQs about 2007 Medicare payments
Editorial Notice: Observer Weekly will not be published on Dec. 26, 2006 and Jan. 2, 2007 due to the Christmas and New Year's holidays.
A comparison of government ratings of hospital performance and death rates found that death rates were only marginally better at highly rated hospitals compared with lower performing ones.
In the study, researchers evaluated 3,657 hospitals listed on the CMS Hospital Compare Web site. The study compared how often hospitals met recommended treatments for heart attacks, heart failure and pneumonia with each hospital’s mortality rate. Researchers found only small differences in mortality rates for hospitals performing at the 75th percentile on all measures within a category vs. those performing lower than the 25th percentile. For example, for heart failure measures, the absolute mortality reduction ranged from 0.1% for inpatient mortality to 0.2% for one-year mortality.
Researchers found similarly small differences in mortality for heart attack and pneumonia patients--less than 2% for any performance measure. The study was published in the Dec. 13 Journal of the American Medical Association.
The findings indicate that outcomes are influenced by more than clinical measures and practice guidelines, said the study's authors. Whether a hospital uses electronic health records and its staffing levels, for example, may also play a role. There is also some question as to the reliability of the data, they continued. For example, low-performing hospitals may try to game the system by excluding patients who do not receive the processes being measured, and the CMS does not have a mechanism to monitor whether data are complete.
However, the effect of performance on mortality rates would remain mild even accounting for possible problems with data collection, said the authors. They suggested that efforts be made to more tightly link CMS performance measures to outcomes rather than processes of care. An accompanying editorial said that the study’s results raised questions about the appropriateness of using Hospital Compare as the basis of pay-for-performance or consumer hospital selection. In the real world, the editorial noted, multiple clinical variables and patient characteristics affect outcomes.
A CMS official, quoted in the Dec. 12 Washington Post, agreed that more quality measures are needed but said that researchers would have found bigger differences between hospitals had they included all 22 measures used on Hospital Compare.
The Journal of the American Medical Association is online.
The Washington Post is online.
Endoscopists had greater detection rates of adenomas when they took longer to withdraw colonoscopes during screenings, a new study found.
The 15-month study followed 12 experienced gastroenterologists who performed 7,882 colonoscopies, of which 2,053 were screening exams in subjects that hadn’t had colonoscopies before and had no history of colorectal cancer or inflammatory bowel disease. The study was published online Dec. 14 by the New England Journal of Medicine.
The study physicians recorded the number, size and histologic features of the neoplastic lesions they detected during the screening exams, as well as the duration of insertion and of withdrawal of the colonoscope. Detection rates were compared for those who had mean withdrawal times of less than six minutes--the suggested minimum time for the procedure--and those who had times of six minutes or more.
Neoplastic lesions (mostly adenomatous polyps) were detected in 23.5% of screened subjects (range: 9.4% to 32.7%). Endoscopists with mean withdrawal times of six minutes or more had a 28.3% detection rate of any neoplasia compared with an 11.8% detection rate for those with withdrawal times of less than six minutes. Detection rates for advanced neoplasia were 6.4% and 2.6%, respectively.
Study results support previous research that found a minimum adequate amount of time for colonoscopic withdrawal--six to 10 minutes is suggested-- can be equated with the quality of colonoscopy. However the authors conceded that while patients stand to benefit from enhanced detection of adenomas, there is relatively small benefit to detecting and removing very small polyps because these rarely progress to cancer.
Because of the relatively small number of endoscopists in this study, the findings should be viewed cautiously and the implications for clinical practice are uncertain, said the authors. The study also did not address whether systematically increasing withdrawal time would be cost-effective.
The New England Journal of Medicine Study is online.
A new study found that the inactivated vaccine found in flu shots may be more effective than live, inhalable vaccines at preventing influenza.
The findings were unexpected, a study co-author told the Dec. 13 New York Times, because it was predicted that use of the live virus would make the inhalable version more effective in a season with poorly matched vaccines. Researchers noted that the study took place during the 2004-05 flu season, a mild year in which circulating viruses were dissimilar to the viruses included in the vaccines. The study was published in the Dec. 14 New England Journal of Medicine.
In the controlled, randomized trial, 1,247 healthy adults in Michigan were vaccinated between October and December 2004 with either inactivated vaccine, live attenuated vaccine or placebo. The vaccines showed similar efficacy against type A flu infections (74% effective), but the inactivated vaccine was more effective against type B flu (80% vs 40%). Overall, the flu shots were 67%-77% effective at preventing flu, while the inhalable vaccine was 30%-50% effective, depending on the method of measuring efficacy.
The degree to which the findings can be generalized is uncertain because of wide confidence intervals in the study and because the vaccines’ relative performances may vary by recipient’s age, preexisting levels of immunity and the specific virus, noted an accompanying editorial. Additional studies are needed to determine vaccine effectiveness in other age groups and the relative efficacy of attenuated live vaccine against type B infections, the editorial said.
The New York Times is online.
The FDA last week approved the first test that can screen blood, organ and tissue donors for the blood-borne parasite that causes Chagas disease. The ORTHO T. cruzi ELISA Test System detects antibodies to the Trypanosoma cruzi (T. cruzi) parasite.
Studies reviewed by the FDA found the test to be accurate 99% or more of the time, detecting 198 out of 199 blood specimens from individuals believed to be infected. In field trials of over 70,000 donor samples, there were two to three false positive individuals per 100,000 test results.
The test is intended for use in screening whole blood, as well as plasma and serum samples from organ, cell and tissue donors. It is currently not approved to diagnose Chagas disease. The test is manufactured by Johnson & Johnson's Ortho-Clinical Diagnostics Inc.
The T. cruzi infection is usually acquired from the bite of an infected insect but also can be transmitted through blood transfusions or organ transplants. Most of the roughly 11 million people infected reside in Latin America, but concern about the potential for transmission in the U.S. through transfusion and transplants has increased due to the rising number of U.S. residents who once lived in countries where infection is common.
About 100,000 people in the U.S. are thought to be infected with Chagas disease, the Dec. 14 New York Times said. The American Red Cross estimated that in the Los Angeles area, the chance of getting a unit of potentially infected blood is 1 in 2,000, compared with the 1 in 10,000 estimated a decade ago, according to the New York Times.
Early infection is usually mild and unrecognized, but persists lifelong and may lead to organ damage, particularly of the heart and esophagus, causing an estimated 50,000 deaths annually worldwide. Infection also can be severe in people whose immune systems are suppressed.
The FDA release is online.
The New York Times is online.
The FDA has ordered firms to stop marketing unapproved drug products containing quinine, and is cautioning against using quinine to prevent or treat leg cramps due to deaths and other serious safety concerns.
Since 1969, the FDA has received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia and severe hypersensitivity reactions.
Only one quinine product, Mutual Pharmaceutical Co. Inc.’s Qualaquin, has FDA approval, and it is approved for treating certain types of malaria. Since malaria is life-threatening, the risks associated with quinine use are justified for that condition, the FDA said. Qualaquin’s label provides extensive warnings regarding serious adverse events associated with its use, potentially serious interactions with other drugs and conditions under which it should not be used.
Many unapproved quinine drug products are marketed without adequate labels, and the FDA hasn’t reviewed their dosing. There is a narrow margin between an effective dose and a toxic dose of quinine, the FDA said.
Under the FDA’s Dec. 11 action, previously manufactured unapproved products may still be found on pharmacy shelves for a short period of time, but manufacturing of new products must cease in 60 days.
The FDA release is online.
The federal government has strengthened recommendations regarding hepatitis B vaccinations for adults. Based on the decision of the Advisory Committee on Immunization Practices (ACIP), CDC guidelines now suggest universal vaccination for adults in high-risk settings.
High-risk settings include STD/HIV testing and treatment facilities, drug-abuse treatment and prevention settings, healthcare providers targeting services to intravenous drug users or men who have sex with men, and correctional facilities. In primary care and specialty medical settings, the CDC recommends implementation of standing orders to identify adults recommended for hepatitis B vaccination and administering vaccine as part of routine services. The new guidelines were published in the CDC’s Dec. 8 Morbidity and Mortality Weekly Report.
To ensure vaccination of adults at risk for HBV infection who have not completed the vaccine series, ACIP recommends the following implementation strategies:
- Provide information to all adults regarding the health benefits of hepatitis B vaccination, including risk factors for HBV infection and persons for whom vaccination is recommended.
- Help all adults assess their need for vaccination by obtaining a history that emphasizes risks for sexual transmission and percutaneous or mucosal exposure to blood.
- Vaccinate all adults who report risks for HBV infection.
- Vaccinate all adults requesting protection from HBV infection, without requiring them to acknowledge a specific risk factor.
The CDC has also launched a new Web site to promote implementation of the revised adult hepatitis B immunization recommendations. It includes educational and other materials specifically designed for each setting where hepatitis B vaccination is recommended for adults, including primary care and specialty medical settings.
The MMWR is online.
The CDC’s new hepatitis B Web site is online.
Shredded lettuce is the most likely culprit in a recent outbreak of E. coli among patrons of Taco Bell restaurants, according to the CDC. As of last week, the bacteria had affected 71 people in five states: New Jersey (33), New York (22), Pennsylvania (13), Delaware (2), and South Carolina (1).
Based on premliminary lab tests, green onions had been suspected as the source of the outbreak, but further testing indicated that the onions were not contaminated, the CDC said. A comparison of the food consumed by healthy and ill Taco Bell patrons pointed to lettuce, ground beef and cheddar cheese as the potential E. coli carriers. After looking at the locations of involved restaurants, the patterns of distribution of food ingredients, and the characteristics and preparation of food ingredients, CDC officials believe lettuce to be the most likely source of contamination.
Tests are continuing on food samples from the restaurants, while health and restaurant officials work together to determine how the lettuce may have been contaminated. The outbreak appears to be over, the CDC said, although additional cases from the outbreak period could still be identified. Illness onset dates ranged from Nov. 20 to Dec. 6, and peaked in the last week of November.
The CDC update is online.
The Dec. 19 issue of Annals of Internal Medicine includes an article about the effectiveness of black cohosh in reducing menopause symptoms and a study of enzyme replacement as treatment for Fabry disease. The full text is available to College members and subscribers online.
Black cohosh no more effective for menopause symptoms than placebo. Data from the Herbal Alternatives for Menopause study, (HALT), found that black cohosh in three formulations performed no better than placebo in reducing hot flashes and night sweats during menopause. The randomized controlled trial assigned women to take either: a black cohosh pill; a multibotanical pill with black cohosh and nine other ingredients; the multibotanical pill plus counseling to encourage intake of soy products; hormone therapy (estrogen with or without progestin); or placebo. Hormone therapy worked as expected in substantially reducing the number and severity of symptoms. None of the black cohosh formulations worked any better than placebo. Black cohosh products are widely used as treatments for menopausal symptoms. The good news, said an accompanying editorial, is that women in the placebo group experienced about a 30% reduction in severity and frequency of symptoms during the 12-month follow-up period. This means that many women will probably have fewer symptoms within six to 12 months without any treatment at all.
Enzyme replacement slowed progression of complications of Fabry disease. Agalsidease-beta therapy for Fabry disease slowed progression of kidney, heart and nervous system complications and death compared with placebo, a new study found. Fabry disease is a hereditary disease in which a faulty gene causes inadequate metabolism of certain fats in the body. The randomized, double-blind placebo-controlled trial was completed by 74 people with advanced Fabry disease and mild to moderate kidney disease. Only one-third of participants developed clinical events. An editorial noted the high cost of lifelong therapy with agalasidase beta and said that therapy should be supplemented with the best standard medical care, with particular emphasis on preventing stroke. The study is posted online and will appear in the Jan. 2, 2007, print edition of Annals of Internal Medicine.
The U.S. Department of Defense is encouraging physicians to accept new TRICARE patients, citing the administrative and payment ease of the program. TRICARE is the Defense Department’s health care program for uniformed services members (active duty, National Guard/Reserve and retirees), their families and other eligible patients.
Physicians do not have to be members of the TRICARE network to see TRICARE patients, as long as they meet licensing and credentialing certification requirements in the state where service is rendered. TRICARE offers the following:
- Paper claims processed in 10 days, on average.
- Electronic claims processed in five days, on average.
- 100% of TRICARE clean claims processed within 60 days, with a return rate of less than 0.8%.
- TRICARE regional contractors provide expedited payments and Internet find-a-provider services.
TRICARE’s patient population has increased in recent years through National Guard and Reserve call-ups and new benefit offerings mandated by Congress, and more of the beneficiaries are living farther from military installations. While active duty service members receive the bulk of their medical care at military treatment facilities, family members, demobilized National Guard and Reserve members and retirees often rely on civilian physicians.
For more information on TRICARE, visit the provider portal on the TRICARE Web site.
ACP has published a new list of Frequently Asked Questions about the “Tax Relief and Health Care Act of 2006” and other changes affecting 2007 Medicare payments.
The list addresses the effects of the Congressional action on Dec. 9 that averted a potential 5% cut to Medicare physician payments. It also explains how the new Congressional action will affect the increased reimbursement levels for evaluation and management (E/M) services. Check back for updates to the FAQs as more information becomes available about the Medicare payment changes.
To find the bottom-line impact of the legislation on your Medicare payments, ACP has also developed an interactive reimbursement calculator for members. This calculator enables you to enter the E/M services you provide in a typical week to determine the revenue change specific to your practice.
The reimbursement calculator is online.
The FAQs are online.
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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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