In the News for the Week of 7-24-07
- Medicaid to require tamper-resistant prescriptions
- Many doctors have stress, sleep trouble after medical mistakes
- High-carb diets linked to AMD
- C. difficile colitis now more common and more severe in hospitalized patients
- Outcomes are better at high-rated hospitals, study finds
- Warfarin hurts more than helps patients with peripheral arterial disease
- Diet high in vegetables, fruit doesn’t affect breast cancer return
- ACP Journal Club: Stress echocardiography safely classified more patients as low risk for serious CAD than exercise electrocardiography
- Restless leg syndrome linked to genetic variations
- CMS warns of potential problem with quality initiative
- Botulism warning for hot dog chili sauce
- FDA approves lab test to detect breast cancer metastasis
- Regents approve health care worker flu vaccination policy
- ACP says SCHIP funding levels in proposed Senate bill are too low
- ACP introduces new Closing the Gap program
A new federal law may force physicians who treat Medicaid patients to update their prescription pads in a hurry. Congress recently passed an emergency spending bill for Iraq which includes a provision requiring prescriptions for Medicaid patients to be written on tamper-resistant pads.
The new requirement, which is intended to prevent drug abuse and to reduce spending, is scheduled to go into effect Oct. 1. President Bush had recommended the change in his 2008 budget and the Congressional Budget Office predicts that it would save the government $355 million over the next decade by preventing fraudulent prescriptions, the July 18 Washington Post reported.
Several states already have similar requirements, but opponents of the new regulation say that health care providers were given much more time to get into compliance with the state regulations. The American Pharmacists Association and the National Association of Chain Drug Stores have issued press releases urging CMS to delay implementation of the law and to provide a clear definition of a tamper-resistant pad.
Three members of Congress, Rep. Charles Wilson (D-OH) and Reps. Marion Berry and Mike Ross (both D-AR) sent a letter to their colleagues last week asking them to contact Medicaid officials about the law. The legislators support the pharmacists and drug stores in their desire to slow down implementation of the tamper-resistant requirement.
The Washington Post is online.
Many doctors experience significant stress, sleep problems and loss of confidence after making medical errors or having near misses, a new survey found.
The survey was completed by 3,171 doctors in internal medicine, pediatrics, family medicine and surgery in St. Louis, Seattle and areas of Canada. More than 2,900 doctors said they had been involved with a near miss, minor medical error or serious error, including mistakes causing permanent or potentially life-threatening harm, the July 18 Washington Post reported. At least 44,000 Americans die from medical errors each year, the article said.
Of doctors involved in errors, 61% reported increased anxiety about future errors; 44% reported loss of confidence; 42% reported sleeping difficulties and 42% said they felt reduced job satisfaction after the errors. Job-related stress increased when doctors had been involved with a serious error, though a third of physicians involved with near misses also reported increased stress. Factors associated with increased distress after serious errors included being dissatisfied with error disclosure to patients and perceiving a greater risk of being sued. Only 10% agreed that health care organizations adequately support them in coping with error-related stress.
Job stress related to medical errors could make some doctors prone to depression, quitting or making additional mistakes, which highlights the need for helping them cope, the study’s lead author told the Washington Post. Organizational resources to support physicians after errors should be improved, the study’s authors concluded. The study is in the August Joint Commission Journal on Quality and Patient Safety.
The Joint Commission Journal on Quality and Patient Safety is online.
The Washington Post is online.
Researchers concluded that 20% of cases of age-related macular degeneration (AMD) would have been eliminated had study participants had a dietary glycemic index (dGI) below median levels.
AMD may share carbohydrate-related mechanisms and risk factors with diabetic retinopathy and cardiovascular disease, so researchers compared the dGI, a measure of how fast carbohydrates are metabolized, in nondiabetic elderly populations.
Researchers obtained dietary information from 4,099 people ages 55 to 80 in the Age-Related Eye Disease Study (AREDS). A total of 8,125 eligible eyes at baseline were classified into five AMD groups according to the size and extent of drusen, and the presence of geographic atrophy and neovascular changes. Researchers used a generalized estimating approach to evaluate the link between dGI and AMD risk and severity.
Eyes in the fourth and fifth quintiles of dGI had a significantly or suggestively higher risk of large drusen, geographic atrophy and neovascularization compared to eyes in the first quintile. Only the odds ratio for large drusen was significant. The study also found a significant positive relation between dGI and severity of AMD.
There was a 49% increase in the risk of advanced AMD (geographic atrophy plus neovascularization) for persons with a dGI higher than the median (women greater than or equal to 77.9; men greater than or equal to 79.3). Researchers reported their findings in the July issue of the American Journal of Clinical Nutrition.
The study abstract is online.
A New York Times report is online.
Clostridium difficile colitis has increased in prevalence and severity in hospitalized patients in the U.S., according to a new study.
Researchers used data from the Nationwide Inpatient Sample to determine the epidemiologic changes in C. difficile colitis in the U.S. between 1993 and 2003. Main outcome measures were disease prevalence, case fatality and total mortality rates, and rate of colectomy. The results appear in the July Archives of Surgery.
From 1993 to 2003, 299,453 patients were discharged from the hospital with a primary or secondary diagnosis of C. difficile colitis. In this time frame, the prevalence of C. difficile colitis increased by 109% (from 261 cases per 100,000 discharged patients to 546 cases per 100,000 discharged patients). The case fatality rate increased from 7.84% in 1993 to 9.26% in 2003, and the total mortality rate increased by 147% (from 20.3 deaths per 100,000 discharges to 50.2 deaths per 100,000 discharges). Finally, the colectomy rate increased from 1.2 per 1,000 cases in 1993 to 3.4 per 1,000 cases in 2003. Increasing calendar year was associated with higher risk for the disease as well as increased severity.
The study results offer proof that C. difficile colitis in the U.S. is changing, the authors wrote, but do not explain the change. The authors speculated that new bacteria strains, increased antibiotic resistance or increasing illness severity and susceptibility to infection may be responsible, and called for further research on the topic.
The Archives of Surgery is online.
Patients who receive care at high-rated hospitals for three common conditions are more likely to have good outcomes, according to a new study.
Researchers at Harvard used the Hospital Quality Alliance (HQA), a national public reporting program from the U.S. Department of Health and Human Services that collects data on quality of care for acute myocardial infarction (MI), congestive heart failure (CHF) and pneumonia, to determine the relationship between hospital ratings and patient outcome. The results appear in the July/August Health Affairs.
The study authors examined data from 3,720 hospitals from 2004 to 2005 and found that those in the lowest HQA performance quartile had adjusted predicted mortality rates of 10.8% for acute MI, 5.0% for CHF and 7.9% for pneumonia, versus 10.0%, 4.6% and 7.1%, respectively, at the highest-quartile hospitals. The authors calculated that 2,200 deaths would have been avoided if the lowest-quartile hospitals had had the same mortality rates as the highest-quartile hospitals. After adjustment for clustering, patients at the highest-quartile hospitals were 11% less likely to die of acute MI, 7% less likely to die of CHF and 15% less likely to die of pneumonia than those at the lowest-quartile hospitals.
The authors pointed out that the HQA tracks only three conditions among elderly patients on Medicare. However, they stated, their results show that the HQA indicators are important for predicting patient outcomes.
Health Affairs is online.
Patients with peripheral arterial disease (PAD) who combined anticoagulant and antiplatelet therapy had about the same rate of cardiovascular complications and more life-threatening bleeding than those who received only antiplatelet therapy, according to a new study.
In the randomized trial, researchers put 2,161 PAD patients on either combination therapy or an antiplatelet agent alone. The mean follow-up time was 35 months, and the measured outcomes were myocardial infarction, stroke, severe ischemia of peripheral or coronary arteries or death from cardiovascular causes.
In the combination group, 15.9% of the patients reached one of the outcomes compared with 17.4% of the antiplatelet group—a difference that did not meet the study authors’ standard for significance. Life-threatening bleeding occurred in 43 combination patients (4.0%) and 13 antiplatelet patients (1.2%). The study was published in the July 19 New England Journal of Medicine.
Based on the findings, study authors extrapolated that treating 1,000 patients with combination therapy instead of antiplatelets only for three years would lead to 24 fewer cardiovascular events but 28 more episodes of life-threatening bleeding, a net increase in serious adverse outcomes. Given the relatively high rate of bleeding, the authors also speculated that patients with PAD may be more likely than non-PAD patients to have bleeding complications from anticoagulant therapy.
An accompanying editorial noted that further research is needed to uncover the pathobiologic basis for bleeding in patients with PAD so that clinical strategies to prevent bleeding can be developed and safer antiplatelet and anticoagulant drugs designed.
See also the latest "ACP Observer Extra" on PAD.
A low-fat diet that is very high in fruits, vegetables and fiber doesn’t prevent breast cancer recurrence, a study in the July 18 Journal of the American Medical Association found.
The multicenter study involved 3,088 women with an average age of 53 who had been successfully treated for early-stage breast cancer. About half were randomly assigned to receive a phone counseling program, cooking classes and newsletters that promoted five vegetable servings a day plus 16 ounces of vegetable juice, three fruit servings, 30 grams of fiber and 15% to 20% intake from fat. The other women were given printed materials describing the U.S. recommended guidelines of five fruits and vegetables a day. Mean follow-up was 7.3 years.
For at least four years, the intervention group ate 65% more vegetables, 25% more fruit and 30% more fiber, as well as lowering energy intake from fat by 13% more than the control group. (Fruit and vegetable intake was validated by measuring plasma carotenoid levels.) At follow-up, 256 women in the intervention group, or 16.7%, experienced an invasive breast cancer event compared with 262 women, or 16.9%, in the control group. Also, 155 women, or 10.1%, died in the intervention group vs. 160 women, or 10.3%, in the control group.
The authors cautioned against applying the results to groups of women other than those represented in the study. The study didn’t examine whether a high vegetable/fruit/fiber and low-fat diet increases longer-term survivorship, or whether it might prevent primary breast cancer. It also didn’t examine the possibility that increased exercise and weight loss might benefit survivors, they said. An editorial writer noted that the intervention group failed to reach its fat reduction goal, the significance of which remains unclear.
The Journal of the American Medical Association is online.
The Washington Post is online.
A new study of patients with suspected acute coronary syndrome and a negative cardiac troponin test found that stress echocardiography (SEcho) had lower total costs than exercise electrocardiography (ExECG) because it eliminated the need for additional diagnostic tests, without increasing overall risk for a cardiac event.
In the randomized, controlled trial of 433 patients at a hospital in England, risk for serious coronary artery disease (CAD) was determined by SEcho, using either treadmill or pharmacologic testing, or ExECG. The attending physician made management decisions based on the results of the stress tests. In general, patients at low risk were discharged, those at intermediate risk had further testing, and those at high risk were referred to a cardiologist.
The end points were cardiac death, myocardial infarction, coronary artery revascularization, proportion of patients assigned to each risk stratum, use of additional diagnostic tests and total cost of diagnosis. The study found that the groups did not differ for the composite cardiac end point. More patients were classified as low risk and fewer patients as intermediate or high risk after SEcho than after ExECG. Because fewer patients who received SEcho required further diagnostic testing, the mean total cost of CAD diagnosis was lower in the SEcho group. The study was abstracted in July/August ACP Journal Club.
The trial does not address the role of nuclear perfusion imaging, which could also be less expensive than ExECG if it is proven to have similar test characteristics to SEcho, noted Journal Club reviewer Paul A. Heidenreich, MS, ACP Member, of Stanford University. He concluded that confirmatory studies (in both acute and chronic angina) are needed before a clear recommendation can be made but that, at the current time, SEcho is a reasonable and probably less expensive alternative to ExECG for patients with low- to intermediate-risk unstable angina.
Peer ratings for this review: Cardiologists: 5/7 stars. Hospitalists: 6/7 stars.
ACP Journal Club is online.
Two new studies found genetic variations that are associated with periodic limb movements in sleep and restless leg syndrome (RLS). The genetic findings should provide evidence that the controversial RLS is a true medical disorder, according to one study author.
The first study, published in the July 19 New England Journal of Medicine, was a genomewide association study of more than 1,000 people from the U.S. and Iceland. They found a specific gene variation present in people who have periodic limb movements in sleep, in addition to an association between the movements and low iron levels. The second study, published in Nature Genetics, compared DNA of 400 Germans and Canadians with a family history of RLS to 1,600 without a history. The researchers found variations in the same genome identified in the first study that were associated with a 50% increased risk of RLS.
According to the lead author of the NEJM study, the results demonstrate the power of genetics to define diseases such as RLS and establish them as medical conditions, the July 18 Washington Post reported. The author of an editorial in the NEJM countered that the genetic link does not validate RLS as a genuine disorder because many normal physiological features (height, eye color) have genetic bases. He concluded that RLS’s status as a bona fide disorder is instead supported by well-documented sleep disturbances and distress experienced by the 3% of the adult population that has RLS.
The ACP Foundation offers free patient education HEALTH TiPS on RLS online.
The Washington Post is online.
The CMS has warned health care providers and billing services of a potential problem with the Physician Quality Reporting Initiative (PQRI). According to an e-mail issued by CMS last week, some billing clearinghouses have been removing the newly implemented National Provider Identifier (NPI) numbers from claims before they are submitted to Medicare.
Without the NPI number, eligible professionals’ claims will not count towards participation in PQRI, CMS officials said. The agency is encouraging providers to verify with their clearinghouses that NPI numbers are not being removed from their claims. If the numbers are being removed, CMS recommends that providers try to rectify the situation or consider other options.
The PQRI, which began on July 1, allows physicians to receive a bonus payment for successfully reporting on quality measures through the claims process for services furnished to beneficiaries over the course of a six-month period ending Dec. 31. Those who successfully report—internists generally have to report on three PQRI quality measures—will earn a bonus that equals 1.5% of the Medicare-allowed charges that they generated during the six-month reporting period.
For more information on the PQRI, go to ACP’s Practice Management Center’s PQRI information page.
The FDA warned consumers last week to avoid certain cans of hot dog chili sauce after four people were hospitalized with botulism after consuming the sauce. The warning applies to 10-ounce cans of Hot Dog Chili Sauce, sold under the brand names Castleberry’s, Austex and Kroger, with "best by" dates from April 30, 2009 through May 22, 2009.
This is the first case of botulism in a commercially canned product since the 1970s, CDC officials told the July 19 Washington Post. There are about 25 cases of the disease reported each year, usually involving home-canned food, the CDC said. Botulism is caused by the bacterium Clostridium botulinum and causes symptoms including double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth and progressive muscle weakness.
The four victims—two children in Texas and an adult couple in Indiana—are seriously ill but expected to survive, the Washington Post reported. Consumers who have any of the recalled cans are urged to throw them out without opening them, because the toxin could sicken people through skin contact or inhalation.
The FDA release is online.
The Washington Post is online.
The FDA approved the following first-of-their-kind medical items last week:
- The GeneSearch BLN Assay, a molecular-based lab test to detect whether breast cancer has metastasized to nearby lymph nodes. A clinical trial of 416 patients found the test correctly predicted metastasis almost 88% of the time, and lack of metastasis 94% of the time. Compared with microscopic examination of lymph nodes during surgery, the test gave fewer false negatives but slightly more false positives. A false positive can result in a more extensive surgery and put women at risk of unnecessary lymphedema and other side effects, the FDA said. The test is made by Veridex, a Johnson & Johnson company.
- The Prestige Cervical Disc for degenerative disc disease. The device’s two pieces of hinged stainless steel are attached to adjacent vertebrae with bone screws after the damaged disc is removed. A clinical trial of 541 patients found the replacement disc improved neck and/or arm pain, and was as safe and effective a treatment as cervical fusion. It is manufactured by Medtronic Sofamor Danek.
The FDA release on the GeneSearch BLN Assay is online.
The FDA release on the Prestige Cervical Disc is online.
At its July 14-15 meeting, the Board of Regents approved a policy to require annual flu vaccinations for health care workers, as well as new clinical guidelines and a resolution to improve pay-for-performance programs. Following are highlights of items approved at the meeting.
Flu vaccine. Every health care worker with direct patient care activities should be required to receive an annual influenza vaccine, unless he or she has a medical contraindication or religious objection, or has signed an informed declination.
Clinical guidelines. Clinical practice guidelines on diagnosis and management of stable chronic obstructive pulmonary disease; diagnosis and treatment of lower back pain; and interventions to improve palliative care of pain, dyspnea and depression at the end of life were approved and will be published in future issues of Annals of Internal Medicine.
Health disparities. The board approved a proposal from the African American Task Force that says, in part, that the College must develop a policy around improving care for underserved populations; encourage sessions about health disparities among African Americans at the College’s annual meeting; develop resources to assist private practice doctors who serve minority populations; and develop strategies to increase the number of African Americans who attain Fellowship.
Pay-for-performance (P4P). The College will work with other health care groups to develop specific ways (like including appropriate sample size and patient non-adherence issues) that P4P programs can better assess a doctor’s effort to improve patient care.
Patient-Centered Medical Home (PCMH). The Board approved measures to ensure that the model can be implemented and maintained by solo practices and smaller medical groups, including payment for start-up costs. The PCMH would modify the current fee-for-service reimbursement model and pay primary care doctors for coordinating all aspects of a patient's care.
Tiered payments. The College will work with health plans on tiered measuring systems to ensure an appeal process for inaccurate claims data, as well as assure that doctors can review performance data for accuracy in advance of public release of tiered payment structures by insurers. Associate membership. Resident physicians and fellows-in-training from countries without chapters, under certain conditions, will be approved for associate membership.
Health care reform. A white paper summarizing state efforts to reform health care, as well as recommendations on key elements that state plans should include in reform, was approved. It included:
- Work towards either achieving universal coverage, or substantially reducing the numbers of uninsured within five years;
- Provide coverage for a core package of preventive and primary care services and for catastrophic expenses, at a minimum; and
- Include reimbursement reforms to support the value of patient-centered care managed by a primary physician.
The Herbert S. Waxman Learning Center. The center will be renamed the Herbert S. Waxman Clinical Skills Center, to more accurately reflect its activities.
ACP expressed concern last week to the Senate Finance Committee that proposed legislation to reauthorize the State Children’s Health Insurance Program (SCHIP) does not contain sufficient funding levels for the program and does not address pending Medicare cuts for physicians.
Joel S. Levine, FACP, chair of ACP’s Board of Regents, described ACP’s concerns in a letter to senators Max Baucus (D-MT), chairman of the Finance Committee, and Charles E. Grassley (R-IA), ranking member of the Finance Committee.
“Children and seniors alike need Congress to take action to assure continued access to good health care,” wrote Dr. Levine. “We appreciate the efforts that Senator Baucus and Senator Grassley have made to maintain and improve SCHIP, and particularly, their courage in taking on ‘big tobacco’ to provide health care to kids. At the same time, we will continue to urge lawmakers to provide sufficient funding to cover more vulnerable children and avert cuts that will reduce elderly patients’ access to Medicare.”
Without reauthorization, SCHIP will expire on Sept. 30. Reauthorization legislation was passed by the Senate Finance Committee on July 19. As of press time, the bill was waiting to be voted on by the full Senate.
ACP’s press release is online.
ACP’s Closing the Gap programs help physicians and their staff develop strategies for improving their practices. This summer ACP introduces a new Closing the Gap program: “Cardiovascular Risk and Secondary Prevention,” a team-oriented, multi-format, practice-based, online educational intervention.
The program encourages physicians to implement system changes in their practices to improve the care they provide to patients with cardiovascular risk and secondary prevention. It incorporates the Chronic Care Model for systems change, the Institute for Healthcare Improvement Breakthrough Series Model of social learning, and the Plan-Do-Study-Act cycle for quality improvement.
There are several benefits to members who participate, including extensive educational materials and resources, CME credit and ABIM recognition for recertification. To participate, members assemble a team of one physician, one nurse and an administrator, attend one full-day training session and provide practice data and progress reports.
Closing the Gap: Cardiovascular Risk and Secondary Prevention sign up forms are online.
If you have any questions about this study or would like more information, contact Lia Verbonitz in ACP’s Clinical Programs and Quality of Care Department at 215-351-2602 or email@example.com.
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A 49-year-old man is evaluated during a routine examination. He is asymptomatic but is concerned about his risk for cardiovascular disease. Medical history is notable for hypertension. He is a nonsmoker, and he works as an executive at a highly successful company. Family history is noncontributory. His only medication is hydrochlorothiazide. Following a physical exam and cholesterol and glucose testing, what is the most appropriate next step in management?
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