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ACP InternistWeekly



In the News for the Week of May 15, 2012




Highlights

Criteria describe appropriate use of cardiac cath

New criteria provide guidance on when cardiac catheterization is appropriate to evaluate patients for heart disease. The appropriate use criteria were released last week by the American College of Cardiology Foundation and the Society for Cardiovascular Angiography and Interventions. More...

New guidelines released on lupus nephritis

The American College of Rheumatology released new guidelines last week on the screening, treatment and management of lupus nephritis, the first to specifically cover this topic. More...


Test yourself

MKSAP Quiz: worsening gait unsteadiness and falls

This week's quiz asks readers to evaluate a 65-year-old man for worsening gait unsteadiness and falls. More...


Screening

Laxative-free CT colonography may be acceptable alternative for cancer screening

Colon cancer screening with laxative-free computed tomographic colonography offers a better experience for patients and may be an acceptable alternate method, a new study indicates. More...


Women's health

Copper IUDs effective as emergency contraception

Copper intrauterine devices (IUDs) are safe and highly effective for emergency contraception and regular contraception and are extremely cost-effective as an ongoing method, authors of a meta-analysis concluded. More...


Ethics and safety in research

Data monitoring committee ends behavioral COPD trial early

Scheduled safety monitoring should occur during behavioral intervention trials in case of unexpected outcomes, according to the authors of one such study for chronic obstructive pulmonary disease (COPD) that recorded excess deaths in the intervention group. More...


FDA update

Benefits of bisphosphonates after five years debated

Bisphosphonate treatment that continues beyond five years might not provide additional fracture prevention benefit, concluded a review by the FDA. More...


CMS update

CMS modifies online enrollment

CMS has been making changes to its online enrollment system, PECOS. More...

CMS will distribute missing bonus payments for Palmetto GBA

CMS has announced that missing Primary Care Incentive Payment first quarter payments for physicians in the Palmetto GBA Medicare jurisdiction will be included in the July 2012 payment. More...


Education

Course on healing health care disparities through education

Medical educators are invited to attend a two-day course featuring interactive methods for achieving the recently mandated integration of cross-cultural care into medical school and residency programs. More...


Quality measures

National Quality Forum endorses preventive care and screening measures

The National Quality Forum (NQF) has recently endorsed 19 quality measures related to preventive care and screening. More...


Cartoon caption contest

Put words in our mouth

ACP InternistWeekly wants readers to create captions for our new cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service. More...


Physician editor: Daisy Smith, MD, FACP



Highlights


.
Criteria describe appropriate use of cardiac cath

New criteria provide guidance on when cardiac catheterization is appropriate to evaluate patients for heart disease. The appropriate use criteria were released last week by the American College of Cardiology Foundation and the Society for Cardiovascular Angiography and Interventions.

The expert panel that developed the criteria identified 166 possible clinical scenarios in which diagnostic catheterization might be considered and then divided them into appropriate, inappropriate and uncertain uses. Cardiac catheterization was determined to be appropriate in 75 of the situations, uncertain in 49 and inappropriate in 42. The authors noted that use of catheterization is still reasonable in the uncertain situations, so that designation should not be used as grounds for denial of reimbursement.

The criteria primarily focus on the use of catheterization to detect blockages in the arteries that are indicative of coronary artery disease (CAD), but the panel also considered a number of other areas, including arrhythmia workup, preoperative testing and possible valve disease or pulmonary hypertension.

Among other situations, the panel advised that cardiac catheterization is appropriate in patients:

  • without prior stress testing but who report symptoms and have a high pretest probability of heart disease, or high likelihood of disease in the physician's judgment;
  • with definite or suspected acute coronary syndrome;
  • with typical symptoms and intermediate- or high-risk findings on prior diagnostic testing.

The panel noted certain situations in which individuals should not be referred directly to cardiac catheterization. Among others, these include:

  • asymptomatic patients at low risk for CAD or without significant symptoms suggestive of heart disease;
  • patients preparing for non-cardiac surgery who have good functional or exercise capacity and/or
  • patients undergoing low-risk surgeries (If a patient has significant risk factors or is undergoing transplantation or heart valve surgery, diagnostic catheterization is warranted, the experts said).

These criteria will be translated into order sheets and decision support tools by the writing organizations. They were developed in collaboration with the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography and Society for Cardiovascular Magnetic Resonance and the Society of Thoracic Surgeons. The criteria were published in the May 29 Journal of the American College of Cardiology as well as in Catheterization and Cardiovascular Interventions and the Journal of Thoracic and Cardiovascular Surgery.


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New guidelines released on lupus nephritis

The American College of Rheumatology released new guidelines last week on the screening, treatment and management of lupus nephritis, the first to specifically cover this topic.

According to the guidelines, 35% of adults in the U.S. with systemic lupus erythematosus have clinical signs of nephritis at diagnosis, and a total of 50% to 60% are estimated to develop nephritis in the first 10 years of the disease. African Americans and Hispanics are more likely to develop nephritis than whites, and men are more likely to develop it than women.

To provide expert advice for practicing clinicians managing patients with this condition, the American College of Rheumatology convened a task force panel to review previous guidelines, perform a systematic review of the evidence, grade the strength of the evidence, and create clinical scenarios, which were then discussed and voted on to arrive at the final recommendations.

The task force panel made recommendations in the following categories:

  • renal biopsy and histology,
  • adjunctive treatments,
  • induction of improvement in patients with disease of increasing severity,
  • maintenance of improvement in patients who respond to induction therapy,
  • modification of therapies in patients who do not respond adequately to induction therapy,
  • identification of vascular disease in patients with systemic lupus erythematosus and renal abnormalities,
  • treatment of lupus nephritis in pregnant patients and
  • monitoring activity of lupus nephritis.

The authors acknowledged that the guidelines are limited because panel members could not agree on definitions of some terms, including remission, flare and response, and also noted that no data are currently available to support specific recommendations on dosing steroids and tapering immunosuppressive drugs. They called for further research in these areas, as well as more studies on how new therapies for lupus can be used in patients with lupus nephritis.

The guidelines were published online May 3 by Arthritis Care & Research.



Test yourself


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MKSAP Quiz: worsening gait unsteadiness and falls

A 65-year-old man is evaluated for worsening gait unsteadiness and falls. He first noticed the unsteadiness 1 year ago while walking and has started to fall recently, falling four times in the past 2 weeks. Approximately 3 years ago, he developed erectile dysfunction and has had increasing constipation ever since that time.

mksap.jpg

On physical examination, vital signs are normal except for the supine blood pressure, which is 190/105 mm Hg; blood pressure decreases to 76/50 mm Hg when he stands without a compensatory increase in the pulse rate. Results of mental status testing are normal. He has mildly slurred speech. Testing of cranial nerve function, including testing of extraocular movements, reveals no abnormalities. Manual muscle strength in the upper and lower extremities is normal, but he has mild rigidity of the extremities and mild appendicular ataxia. His gait is slow with a reduced stride length and arm swing, and he has marked postural instability.

Which of the following is the most likely diagnosis?

A) Dementia with Lewy bodies
B) Multiple system atrophy
C) Parkinson disease
D) Progressive supranuclear palsy

Click here or scroll to the bottom of the page for the answer and critique.


.

Screening


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Laxative-free CT colonography may be acceptable alternative for cancer screening

Colon cancer screening with laxative-free computed tomographic colonography (CTC) offers a better experience for patients and may be an acceptable alternate method, a new study indicates.

Researchers performed a prospective test comparison of laxative-free CTC, which included electronic bowel cleansing and computer-aided detection, and optical colonoscopy in 605 adults 50 to 85 years of age (53% men, 47% women) who were at average to moderate risk for colon cancer. For electronic bowel cleansing, patients followed a low-fiber diet and ingested small amounts of contrast material to tag feces, which computer software then removed from the CTC images while maintaining the size and appearance of mucosal folds and polyps. Technicians performing the optical colonoscopies did not know the CTC results until colonoscope withdrawal, at which time reexamination could be done to resolve discrepant findings.

annals.jpg

The reference standard was unblinded optical colonoscopy. Outcome measures were per patient sensitivity and specificity of CTC and initial optical colonoscopy for detection of adenomas 10 mm or greater, 8 mm or greater, and 6 mm or greater. Sensitivity per lesion and survey data on patients' experience with the exam and with preparation were also examined. The results of the study, which was funded by GE Healthcare and the American Cancer Society, appear in the May 15 Annals of Internal Medicine.

Per patient sensitivity for adenomas 10 mm or larger was 0.91 (95% CI, 0.71 to 0.99) for CTC and 0.95 (95% CI, 0.77 to 1.00) for optical colonoscopy; specificity was 0.85 (95% CI, 0.82 to 0.88) and 0.89 (95% CI, 0.86 to 0.91), respectively. For adenomas 8 mm or larger and 6 mm or larger, respectively, CTC had a sensitivity of 0.70 (95% CI, 0.53 to 0.83) and 0.59 (95% CI, 0.47 to 0.70) while optical colonoscopy had a sensitivity of 0.88 (95% CI, 0.73 to 0.96) and 0.76 (95% CI, 0.64 to 0.85). Optical colonoscopy had a specificity of 0.91 at 8 mm or larger and 0.94 at 6 mm or larger versus 0.86 and 0.88, respectively, for CTC (P=0.02). Patients reported more comfort and less difficult exam prep for CTC compared with optical colonoscopy.

The authors acknowledged that only three people interpreted the CTC results and that the survey instrument used to assess patients' experience was not independently validated, among other limitations. However, they concluded that CTC offered a better patient experience and accurately detected larger adenomas (10 mm or larger), although it was not as accurate in detecting smaller lesions. "Our results suggest a role for CTC as an alternate screening method to [optical colonoscopy] with which participants would experience improved preparation and examination comfort—factors that could contribute positively to overall screening participation," the authors wrote.



Women's health


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Copper IUDs effective as emergency contraception

Copper intrauterine devices (IUDs) are safe and highly effective for emergency contraception and regular contraception and are extremely cost-effective as an ongoing method, authors of a meta-analysis concluded.

To evaluate the existing data to estimate the efficacy of IUDs for emergency contraception, researchers reviewed studies published in English or Chinese, with a defined population of women who presented for emergency contraception and were provided with an IUD, and in whom the number of pregnancies was ascertained and loss to follow-up was clearly defined.

Forty-two studies from six countries between 1979 and 2011 included eight different types of IUDs and 7,034 women. The maximum timeframe from intercourse to insertion of the IUD ranged from 2 days to 10 or more days; the majority of insertions (74% of studies) occurred within 5 days of intercourse.

Results appeared online May 8 in Human Reproduction.

Among 7,034 post-coital IUD insertions, there were 10 pregnancies, for an overall failure rate of 0.14% (95% CI, 0.08% to 0.25%). Six pregnancies occurred among 5,629 subjects in the studies conducted in China (failure rate, 0.11%; 95% CI, 0.05% to 0.23%) and the remaining four pregnancies occurred among 200 subjects in one study conducted in Egypt. The latter study was considered an outlier, and without it the overall failure rate would be 0.09% (95% CI, 0.04% to 0.19%).

The authors concluded that IUDs are a highly effective method of contraception after unprotected intercourse because they are safe for the majority of women, highly effective and cost-effective when left in place as ongoing contraception for as long as 10 years, with some evidence for longer use.

"The cost, clinical protocols and lack of awareness among both patients and providers are barriers to a greater uptake of IUDs for emergency contraception," the authors wrote. "Increasing the use of IUDs for emergency contraception is an important strategy for reducing an individual woman's chance of becoming pregnant after unprotected intercourse. In addition, if left in place for ongoing contraception, copper IUDs provide highly effective contraception for at least 10 years, and can contribute to decreasing unintended pregnancy rates over the long term."



Ethics and safety in research


.
Data monitoring committee ends behavioral COPD trial early

Scheduled safety monitoring should occur during behavioral intervention trials in case of unexpected outcomes, according to the authors of one such study for chronic obstructive pulmonary disease (COPD) that recorded excess deaths in the intervention group.

annals.jpg

The stated purpose of the study was to determine the efficacy of a comprehensive care management program in reducing the risk for COPD hospitalization. Researchers created a randomized, controlled trial comparing behavioral interventions with guideline-based usual care at 20 Veterans Affairs outpatient clinics for patients hospitalized for COPD in the past year. The primary outcome was time to first COPD hospitalization.

Results, and a consideration of the ethics of such trials, appeared in the May 15 Annals of Internal Medicine.

Intervention patients received a written, individualized action plan for flare-ups that included prescriptions for prednisone and an antibiotic chosen in consultation with the primary care physician, with instructions to start treatment within 48 hours after onset of exacerbation symptoms.

In contrast to other behavioral intervention studies, which typically use a safety officer, VA trials require a data monitoring committee. The study began enrollment in January 2007. A scheduled meeting of the committee in January 2009 revealed an imbalance in mortality between the study groups.

After failing to find any reason for the difference, the data monitoring committee recommended that study enrollment and the intervention be stopped immediately, and that all patients have all baseline studies repeated with follow-up in an observational study lasting six months.

By that point, 426 (44%) of the planned total of 960 patients were enrolled. There were 28 deaths from all causes in the intervention group versus 10 in the usual care group (hazard ratio, 3.00 [95% CI, 1.46 to 6.17]; P=0.003).

Cause could be assigned in 27 (71%) deaths. Deaths due to COPD accounted for the largest difference: 10 in the intervention group versus 3 in the usual care group (hazard ratio, 3.60 [95% CI, 0.99 to 13.08]; P=0.053).

Not all educational and care management programs are appropriate for all patients, the authors concluded.

"This study underscores the critical role of the DMC [data monitoring committee] in ensuring the safety of study patients and questioning current clinical trial practices," the authors wrote.

An editorialist discussed the consequences of stopping a trial early, including that it may exaggerate the true effect because the trial may stop on a "random high," whereas the observed difference might well have regressed. Furthermore, there was no clear pattern consistent with a plausible reason for harm, and the primary end point and other outcome measures show no evidence of a treatment effect one way or another, the editorialist said.

The editorialist compiled the results of this trial and two others of behavioral interventions for COPD. All three trials combined showed no difference in mortality rates between behavioral interventions and usual care.

"It may be best to think of this trial as having stopped for futility—there was no hint of any beneficial effect on the primary outcome," the editorialist wrote. "On the other hand, the possibility that genuine harm was done by this behavioral intervention cannot be dismissed. Perhaps insufficient evidence was collected by the investigators about the detailed consequences of the educational package, thus denying us any causal insight into the excess mortality."



FDA update


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Benefits of bisphosphonates after five years debated

Bisphosphonate treatment that continues beyond five years might not provide additional fracture prevention benefit, concluded a review by the FDA.

The review included three long-term extension trials in which duration of treatment ranged from six to 10 years. After pooling data, the reviewers concluded that patients who took the drugs for six or more years had similar fracture rates to those who switched to placebo during the extension trials (9.3% to 10.6% with drugs vs. 8.0% to 8.8% on placebo). "These data raise the question of whether continued bisphosphonate therapy imparts additional fracture-prevention benefit, relative to cessation of therapy after 5 years," the FDA reviewers wrote in a perspective in the New England Journal of Medicine. Given the uncertainty, they recommended treatment decisions be based on individual assessment of risks and benefits and patient preference.

Another perspective, also published online by the New England Journal of Medicine on May 9, offered more specific advice about treatment. Based on a re-analysis of two of the trials considered by the FDA, the authors focused on risk of vertebral fractures and concluded that:

  • patients with a femoral neck T score below −2.5 after three to five years of bisphosphonates are at highest risk and benefit most from continuation of drug therapy,
  • patients with a score of −2.0 to −2.5 may also benefit from continued therapy and
  • patients with a score above −2.0 are at low risk and unlikely to benefit from continued therapy.

These recommendations about discontinuation apply only to alendronate and zoledronic acid, the perspective authors noted. They also suggested that lower doses might be considered for long-term use, although the safety of this is unknown.



CMS update


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CMS modifies online enrollment

CMS has been making changes to its online enrollment system, PECOS. Users will now to be able to:

  • filter the enrollments shown on the My Enrollments Page based on Medicare ID or National Provider Identifier (NPI), or by selecting an Enrollment Type, Enrollment Status, or State. Additional data have been added to the enrollment data on the My Enrollments Page, i.e., Enrollment Type, Medicare ID, and Practice Location;
  • see if a request for revalidation has been sent by the Medicare Administrative Contractor (MAC);
  • identify those enrollments that are accredited for Advanced Diagnostic Imaging (ADI) Services and
  • complete and submit electronic fund transfer (EFT) agreements electronically, with the option to e-sign the document.

If you find that with the new changes you have difficulty accessing the PECOS website, please report the issue to Debra Lansey, in the ACP Regulatory & Insurer Affairs Department.


.
CMS will distribute missing bonus payments for Palmetto GBA

CMS has announced that missing Primary Care Incentive Payment (PCIP) first quarter payments for physicians in the Palmetto GBA Medicare jurisdiction will be included in the July 2012 payment.

Some physicians in this jurisdiction who were eligible for the payments found that they did not receive their April payment. Additional information is available on the Palmetto GBA website.



Education


.
Course on healing health care disparities through education

Medical educators are invited to attend a two-day course featuring interactive methods for achieving the recently mandated integration of cross-cultural care into medical school and residency programs.

The course is offered by Harvard Medical School in Boston, Oct. 12-13, 2012. ACP is endorsing this course, allowing ACP members to enjoy a $50 discount on registration. More information is online.



Quality measures


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National Quality Forum endorses preventive care and screening measures

The National Quality Forum (NQF) has recently endorsed 19 quality measures related to preventive care and screening. The measures address a range of clinical preventive care concerns, including influenza and pneumococcal immunizations across a range of health care settings and screenings for specific types of cancer, sexually transmitted infections, and osteoporosis. The goal of the measures is to help public health care clinicians effectively evaluate and ultimately improve health at the population level.

ACP is an active member of the NQF and regularly participates in the measure endorsement process. The ACP Performance Measurement Committee (PMC) was invited by the NQF's Population Health Prevention Endorsement Maintenance project to review the performance measures. PMC critically reviewed the performance measures based on a standardized measure review criteria. The ACP PMC provided feedback to the NQF through the member comment and voting period.

The following measures were not approved by ACP due to methodological issues, an unclear measure definition, lack of clinical evidence base or the need for harmonization between multiple measures:

  • NQF 0039 Flu shots for ages 50 and over (NCQA),
  • NQF 0041 Influenza immunization (AMA-PCPI),
  • NQF 1653 Pneumococcal immunization (hospital) (CMS),
  • NQF 0033 Chlamydia screening (NCQA),
  • NQF 0032 Cervical cancer screening (NCQA) and
  • NQF 0046 Osteoporosis screening or therapy for women aged 65 years and older (NCQA).

The following measures were approved by ACP:

  • NQF 0431 Influenza vaccination among healthcare personnel (CDC),
  • NQF 0522 Influenza immunization- home health (CMS),
  • NQF 0226 Influenza immunization in the ESRD population (Kidney Care Quality Alliance),
  • NQF 1659 Influenza immunization (hospital) (CMS),
  • NQF 0043 Pneumonia vaccination for older adults (NCQA),
  • NQF 0617 Pneumococcal vaccination (Active Health Management),
  • NQF 0525 Pneumococcal vaccine ever received (home health) (CMS),
  • NQF 0034 Colorectal cancer screening (NCQA),
  • NQF 0579 Annual cervical cancer screening for high-risk patients (Resolution Health, Inc.),
  • NQF 0037 Osteoporosis testing in older women (NCQA),
  • NQF 0614 Steroid use- osteoporosis screening (Active Health Management) and
  • NQF 0629 Male smokers or family history of AAA – screening for AAA (Active Health Management).


Cartoon caption contest


.
Put words in our mouth

ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.

acpi-20120515-cartoon.jpg

E‑mail all entries to acpinternist@acponline.org. ACP staff will choose finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition.


.


MKSAP Answer and Critique



The correct answer is B) Multiple system atrophy. This item is available to MKSAP 15 subscribers as item 22 in the Neurology section. More information about MKSAP 15 is available online.

Multiple system atrophy is the most likely diagnosis in this patient. He has a progressive neurologic disorder characterized by signs and symptoms that suggest impairment of multiple neurologic systems; these include the autonomic nervous system (orthostatic hypotension, erectile dysfunction, constipation), the extrapyramidal system (rigidity, impaired gait), and the cerebellum (limb ataxia). Multiple system atrophy is a progressive, ultimately fatal neurodegenerative disorder that typically causes dysautonomia, parkinsonism, and ataxia, in some combination, in affected patients. Multiple system atrophy is a clinical diagnosis that is suggested by the presence of these various features in the same patient.

Dementia with Lewy bodies is also typically associated with parkinsonian features and should be considered in the differential diagnosis of this patient. Dementia with Lewy bodies is associated with cognitive impairment, parkinsonian signs and symptoms, and possible evidence of dysautonomia. However, gait or limb ataxia is not expected, and the degree of dysautonomia typically is not as severe as that seen in multiple system atrophy.

The prominent dysautonomia, early falls, absence of a resting tremor, and presence of appendicular ataxia in this patient argue against Parkinson disease as the diagnosis. Early multiple system atrophy can, however, be difficult to distinguish from Parkinson disease, especially because some affected patients may respond initially to carbidopa-levodopa, a medication used to treat parkinsonian symptoms in Parkinson disease.

Progressive supranuclear palsy should also be part of the differential diagnosis in this patient. A rare neurodegenerative disorder, progressive supranuclear palsy is associated with parkinsonian signs and early falls due to marked postural instability. However, significant dysautonomia and ataxia are not expected. Marked impairment in vertical gaze is a hallmark of progressive supranuclear palsy.

Key Point

  • Multiple system atrophy is a sporadic, heterogeneous, neurodegenerative disorder that causes impairment of multiple neurologic systems, including the autonomic nervous system, the extrapyramidal system, and the cerebellum.

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Test yourself

A 30-year-old woman is evaluated for episodic migraine without aura that first presented in high school and has persisted into the third trimester of her current pregnancy. The headache attacks occur two to four times monthly and last 12 to 24 hours. She experiences moderately severe pain, significant nausea, no vomiting, and pronounced photophobia with most of the attacks. Her only medication is prenatal vitamins. Physical examination findings, including vital signs, are normal. What is the most appropriate treatment?

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