In the News
for the Week of 2-17-09
- MKSAP quiz: vaginal discharge
- Zoledronic acid improves breast cancer outcomes
- Patent foramen ovale closure may help migraine sufferers
Annals of Internal Medicine
- Medicare’s pay for off-label uses of cancer drugs outdated
- Telephone support for lifestyle changes may help obese patients
- Depending on cost, wider statin use could be a good strategy
- State laws may obstruct CDC HIV screening recommendations
- Survey highlights primary care challenges of patient care coordination
- Fact boxes on DTC ads improve consumer knowledge, decisions
- AMA settles lawsuit and files two more alleging under-reimbursement
From ACP Internist's blog
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Cartoon caption contest
- Put words in our mouth
New opioid therapy guidelines released
Two professional societies released guidelines last week on opioid therapy to treat chronic, noncancer pain.
The American Pain Society and the American Academy of Pain Medicine convened a multidisciplinary panel of 21 experts to review evidence and compose 25 recommendations. The recommendations, published in the February Journal of Pain, advise providers to:
- Do a history, physical exam and appropriate testing—including a risk assessment of substance abuse—before starting a patient on chronic opioid therapy (COT);
- Consider a COT trial for patients whose pain is moderate or severe and for whom it has an adverse impact on function or quality of life;
- Reassess patients on COT periodically, with monitoring to include documenting pain and functioning levels, adherence, and presence of adverse events;
- Use COT on patients with a history of drug abuse or psychiatric issues only if they can be monitored more frequently and strictly;
- Do periodic urine drug screens on patients at high risk or who engaged in drug-related behavior in the past, and possibly on patients who aren't high-risk, too; and
- Evaluate health status, adherence and side effects on an ongoing basis in patients on high doses of COT, and consider more follow-up visits.
On a related note, FDA last week sent letters to opioid manufacturers asking them to develop plans to reduce the misuse of their drugs, the Feb. 9 Washington Post reported. The plans, which are meant to help reduce the rising incidence of overdose and abuse, might include enhanced warnings on labels or restricting the kinds of patients who can use the drugs, the Post said. A list of affected drugs, most of which are high dose and/or extended release, is online..
Care coordination pilot doesn't pay off
A Medicare-supported trial of care coordination mostly failed to reduce hospitalizations or improve quality of care, researchers reported last week.
The study included 15 care coordination programs which provided Medicare beneficiaries with nurse-led patient education and monitoring between April 2002 and June 2005 in exchange for an additional fee from CMS. Claims data from both participating patients and others receiving usual care at the same centers (totalling more than 18,000 people) were compared on the basis of hospitalizations, costs and some quality-of-care outcomes. Care coordination fees and the nature of the interventions varied between programs.
Of the 15 programs, 13 showed no significant difference in hospitalizations, one had a 17% decrease compared with controls while another actually had 19% more hospitalizations in the intervention group. None of the programs generated net savings when the extra payments were included, although three programs lowered patients' average monthly Medicare expenditures by 9%-14%. At the end of the study, Medicare invited two of the three cost-lowering programs to continue; the other enrolled too few patients to be sustainable.
Although the results overall provided little indication that care coordination could reduce expenditures, the study authors did identify some transferrable traits of the successful programs. Both had nearly one in-person contact per month per patient, compared with 0.3 for the unsuccessful programs, which were more phone-based. Also, the programs appeared to have the greatest effect on the medium-risk patients who had monthly expenditures of $900 to $1,200, rather than those who were sicker or healthier. Close interaction between physicians and the care coordinators was also key, the authors said.
Even the most successful care coordination programs are likely to achieve only modest savings, if any, the study authors concluded. They recommended that further research be conducted to determine how best to educate and monitor patients, which patients will most benefit from the programs, and how to help patients overcome barriers to self-care. The study was published in the Feb. 11 Journal of the American Medical Association.
MKSAP quiz: vaginal discharge
An otherwise healthy 25-year-old woman is evaluated because of a white, cheesy, and somewhat malodorous vaginal discharge. She has no dysuria or hematuria and no history of sexually transmitted diseases. The patient has been sexually active with a single male partner for more than 3 years. Her only medication is an oral contraceptive. She and her partner almost always use latex condoms but occasionally have unprotected sexual intercourse.
General physical examination is unremarkable. Pelvic examination discloses a moderately thick, malodorous, white vaginal discharge. The cervix is normal, and no ulcers are seen. The pH of the vaginal secretions is 6.0. A wet prep shows no motile organisms, and cervical specimens are sent for ligase chain reaction testing for both gonorrhea and chlamydial infection. Stained specimens of the vaginal material are shown (Figure 1 and Figure 2).
Which of the following is the most appropriate empiric therapy at this time?
A) A single dose of azithromycin
B) A single dose of ceftriaxone
C) Intravaginal clotrimazole cream
D) Intravaginal clotrimazole cream plus a single dose of ciprofloxacin
E) Intravaginal clotrimazole cream plus a 7-day course of metronidazole
Click here for the answer and critique for this question.
Zoledronic acid improves breast cancer outcomes
Adding zoledronic acid to endocrine therapy can increase disease-free survival among premenopausal women with early breast cancer, according to a new study.
In the randomized trial, researchers assigned 1,803 women with endocrine-responsive cancer to receive goserelin plus either tamoxifen or anastrozole. Some of the women in each group were also given zoledronic acid (4 mg intravenously every six months), which is commonly used for osteoporosis and other bone disorders. The study was published in the Feb. 12 New England Journal of Medicine and supported by AstraZeneca and Novartis.
After about four years, researchers found no significant difference in the disease-free survival rates between the anastrozole and tamoxifen groups. Taking zoledronic acid, however, resulted in a 36% relative reduction in the risk of disease progression. At followup, 90.8% of the non-zoledronic acid group was disease-free compared with 94% of the patients who took the bone drug. Overall survival rates were similar among the groups. Researchers noted that the similar rates of disease-free survival between the anastrozole and tamoxifen groups were surprising, because prior studies of postmenopausal women had found aromatase inhibitors to be superior.
Two other large, similar studies should be complete within a few years, according to the Feb. 12 New York Times. In the meantime, some experts favor starting women like those in the study on the drug now while others are waiting before considering zoledronic acid part of the standard treatment, the New York Times reported.
Patent foramen ovale closure may help migraine sufferers
Closure of patent foramen ovale (PFO) led to significant relief for migraine sufferers who participated in a recent study.
The case-controlled study, published in the February Journal of the American College of Cardiology: Cardiovascular Interventions, was the first to enroll severe migraine patients with a large PFO who had not suffered prior stroke or transient ischemic attacks, but who showed silent brain lesions on magnetic resonance imaging. Previous studies of PFO closure on patients following stroke or decompression illness have resulted in migraine improvements in 75% of patients.
Researchers followed 82 patients with high-grade right-to-left shunt, moderate/severe migraine, and subclinical lesions at MRI. Of those, 53 consented to undergo PFO closure while 29 received standard medical therapy. At six months, the closure group patients reported significant reductions in frequency and severity of attacks. Results included:
- Migraine disappeared in 34% of the closure group vs. 7% of controls;
- Significantly more closure group than control group patients reported a 50% or greater reduction in attacks (87% vs. 21%, respectively) and a 50% or greater reduction in disabling attacks (89% vs. 17%, respectively); and
- Disabling attacks disappeared in 53% of closure group patients vs. 7% of controls.
Researchers cautioned that larger studies are needed to confirm the results and that the relationship between PFO and migraine still isn't clearly understood. Not all patients with PFO, or shunt, suffer migraines and many with a shunt do not have migraine.
Annals of Internal Medicine.
Early release online: Medicare’s pay for off-label uses of cancer drugs outdated
The National Comprehensive Cancer Network estimates that 50%-75% of all uses of cancer therapy are off-label. CMS limits coverage of cancer drugs for off-label indications to those indications listed in specified compendia. The authors of a new study titled, "Reliability of Compendia Methods for Off-Label Oncology Indications," argue that the current methods for reviewing and updating evidence for compendia are seriously lacking. Two perspective pieces here and here and an editorial accompany the article, released early online and scheduled in print for the March 3 Annals of Internal Medicine..
Telephone support for lifestyle changes may help obese patients
Researchers measured weight loss in 376 obese patients taking a daily dose of sibutramine to determine which method of delivering support for a lifestyle modification program would produce the most weight loss. Patients were randomly assigned to high-frequency face-to-face counseling, low-frequency face-to-face counseling, high-frequency telephone counseling, high-frequency e-mail counseling, or no dietician contact. After six months, the patients assigned to high-frequency telephone contact with a dietitian lost the same amount of weight as those assigned to high-frequency face-to-face counseling. Researchers conclude that telephone counseling could be a viable and cost-effective way for primary care physicians to help their obese patients lose more weight. Results appear in the Feb. 17 issue.
A video news report is available here..
Depending on cost, wider statin use could be a good strategy
The Adult Treatment Panel III (ATP III) recommended statins for patients with higher cholesterol and more risk factors for coronary heart disease. Because of poor adherence to ATP III guidelines, researchers sought to determine the strategy’s cost, complexity and efficiency. They found that while the guidelines are complex, they are relatively cost-effective in comparison with alternatives and would be the preferred strategy if statin pill costs are moderate. However, if statin pill costs were lower, extending statin use to lower-risk patients as well would be better..
State laws may obstruct CDC HIV screening recommendations
According to CDC guidelines, all patients should be offered HIV screening without a requirement for written consent or prevention counseling. However, state laws may make it difficult for physicians to adhere to these guidelines. Researchers systematically reviewed and analyzed laws in all 50 states and Washington, D.C. to determine which states’ laws would interfere with implementing the guidelines. They found that 34 states and Washington D.C. had laws that were either consistent or neutral to the recommendations, allowing for full implementation. The other 16 states had laws that would preclude implementation of one or more of the novel provisions for HIV screening. The authors urge policymakers, provider groups, consumer advocates and other stakeholders to review their state laws and advocate for amending laws that interfere with implementing the CDC recommendations..
Survey highlights primary care challenges of patient care coordination
Researchers analyzed survey data from 2,284 primary care physicians and Medicare claims for their patients. For every 100 patients they cared for, physicians said they must interact with as many as 99 other physicians in 53 different practices. Models that try to improve patient care, such as the patient-centered medical home, must have systems that support the coordination of care..
Fact boxes on DTC ads improve consumer knowledge, decisions
Researchers conducted two randomized trials to see if providing consumers with a drug facts box (a table quantifying outcomes with and without the drug) would improve knowledge and affect patient judgments about which prescription drugs are more effective. Researchers found that after reading the ads with fact boxes, consumers made better choices between drugs for current symptoms. In addition, they were better informed about the actual benefit of drugs intended for prevention.
AMA settles lawsuit and files two more alleging under-reimbursement
Having settled one lawsuit with UnitedHealth Group for allegedly under-reimbursing out-of-network physicians, the American Medical Association (AMA) is now pursuing two other health insurers who licensed the insurer's database to set their own reimbursement rates.
The AMA, state medical associations and several doctors filed class-action lawsuits against Aetna Health, Inc. and CIGNA Corporation, claiming the companies under-reimbursed out-of-network physicians. In January, the AMA settled a previously filed lawsuit with UnitedHealth that alleged the same practice.
Two federal lawsuits allege that for more than a decade the two health insurance companies underpaid physicians for out-of-network medical services and forced patients to pay an excessive portion of the costs. The suits allege that the companies relied on data provided by UnitedHealth subsidiary Ingenix to set reimbursement rates for out-of-network care. New York Attorney General Andrew Cuomo had previously alleged that the Ingenix data is intentionally manipulated to allow health plans to shortchange reimbursements on medical bills, a suit that has since also been settled.
CIGNA responded in a release saying that its payments to out-of-network doctors are robust and fair, and that greater transparency about physician pricing proves the point. The release cited the cost of a 15-minute office visit in New York City. Health plans pay $74 to in-network doctors and as much as $160 using the Ingenix database to out-of-network doctors; while out-of-network physicians who charge in excess of the amount previously set by the Ingenix database charge $214 for the same service. (Medicare pays $70 to in-network doctors and $77 to out-of-network doctors for the same office visit.)
An Aetna spokesperson said the medical community has chosen to litigate on top of already pending consumer litigation on the same topic, which could increase health care costs for everyone, adding that Aetna prefers to continue collaborative dialogue with the medical community on the subject.
From ACP Internist's blog.
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Cartoon caption contest.
Put words in our mouth
ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner.
E-mail all entries by Feb. 19. ACP staff will choose three finalists and post them in the Feb. 24 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the March 3 issue. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service..
MKSAP Answer and Critique
Correct Answer = E) Intravaginal clotrimazole cream plus a 7-day course of metronidazole. This topic is available to subscribers in the Infectious Diseases section, item 40.
ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:
- Update your knowledge in all areas of internal medicine
- Prepare for ABIM certification or recertification
- Support your clinical decisions in practice
- Assess your medical knowledge with 1,200 multiple-choice questions
To order the latest edition of MKSAP, go online.
The three most likely diagnoses in a patient with a vaginal discharge are a candidal infection, trichomoniasis, and bacterial vaginosis. A thick, milky vaginal discharge is characteristic of Candida, and a malodorous discharge with a high pH is characteristic of either trichomoniasis or bacterial vaginosis. The diagnosis is determined by the appearance of the stained specimens. Figure 1 shows the pseudohyphae and budding yeast indicative of candidal vaginitis, and Figure 2 shows gram-negative bacilli attached to squamous epithelial cells (clue cells) indicative of bacterial vaginosis. The patient therefore has both a candidal infection and bacterial vaginosis and should be treated with an intravaginal clotrimazole cream for the Candida and metronidazole for the bacterial vaginosis.
The normal appearance of the cervix indicates that a chlamydial infection is unlikely, and empiric treatment with azithromycin is therefore not indicated. The normal cervix and the absence of gram-negative cocci within neutrophils on stained specimens are inconsistent with gonorrhea. Empiric treatment with ceftriaxone or ciprofloxacin for gonorrhea is therefore not indicated.
- Stained specimens of vaginal discharge from patients with candidal vaginitis show pseudohyphae and budding yeast.
- Stained specimens of vaginal discharge from patients with bacterial vaginosis show gram-negative bacilli attached to squamous epithelial cells (clue cells).
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Copyright 2008 by the American College of Physicians.
A 30-year-old woman is evaluated for difficult-to-treat migraine. She has had severe headaches, usually on the first day of menses, since menarche. The pain is hemicranial, pulsatile, and associated with severe nausea and vomiting but no aura. She frequently awakens with the attack already in progress. A series of drug regimens have become ineffective in controlling pain. Following physical and neurological exams, what is the most appropriate next step in treatment?
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