American College of Physicians: Internal Medicine — Doctors for Adults ®

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ACP InternistWeekly



In the News for the Week of November 12, 2013




Highlights

Few high-quality guidelines exist for prescribing opioids

Few high-quality guidelines exist for prescribing opioids to treat chronic pain, a review found, noting that there was at least consensus among guidelines on ways to mitigate opioid-related risks. More...

Gabapentin reduced drinking, cravings, sleep and mood problems in alcoholics

Treatment with gabapentin reduced alcohol consumption and relapse-related symptoms in patients with alcohol dependence, a recent single-center study found. More...


Test yourself

MKSAP Quiz: Pregnancy and a previous idiopathic pulmonary embolism

A 35-year-old woman undergoes evaluation after home pregnancy testing indicated that she is pregnant. Her medical history includes a previous idiopathic pulmonary embolism. Her only medication is a daily prenatal vitamin. Following a physical exam, what is the most appropriate venous thromboembolism prophylaxis for this patient? More...


Men's health

Testosterone therapy may be associated with increased risk of mortality and cardiovascular events

Testosterone therapy was associated with increased risk of mortality, myocardial infarction (MI) or ischemic stroke among men in the Veterans Administration (VA) health care system, a study found. More...


Hypertension

Tailoring antihypertensive treatment to cardiovascular benefits may improve outcomes

Tailoring antihypertensive treatment to cardiovascular benefits rather than specific blood pressure targets may improve outcomes and result in less medication use, according to a new study using simulation models. More...


Guidelines

New recommendations on diagnosis and treatment of Bell's palsy

Recommendations on diagnosing and treating Bell's palsy were recently provided by a new clinical practice guideline from the American Academy of OtolaryngologyHead and Neck Surgery Foundation. More...


CMS update

CMS confirms payment rules will be issued in November

The recent federal government shutdown had caused some concern that CMS would not be able to issue its year-end final rules in time. More...

2012 PQRS feedback reports available

Reports are now available for physicians who participated in the 2012 Physician Quality Reporting System (PQRS). More...


From ACP Internist

ACP Internist's latest edition is online and coming to your mailbox

The November/December edition of ACP Internist features stories about patients self-diagnosing by using "Dr. Google," effective low back pain care, and physicians trying to protect their online reputations. More...


From the College

ACP LEAD transition deadline reminder

College members currently pursuing an ACP Leadership Enhancement and Development (LEAD) Certificate must declare their intent to complete the requirements by e-mailing ACP at LEAD@acponline.org by Dec. 31, 2013. To earn a LEAD certificate, physicians must participate in 5 out of 7 LEAD activities and complete an application by June 30, 2014. 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


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Few high-quality guidelines exist for prescribing opioids

Few high-quality guidelines exist for prescribing opioids to treat chronic pain, a review found, noting that there was at least consensus among guidelines on ways to mitigate opioid-related risks.

annals.jpg

Researchers looked at MEDLINE, the National Guideline Clearinghouse, specialty society websites, and international guideline clearinghouses in July 2013 for guidelines published since January 2007 that addressed using opioids for chronic pain in adults. Guidelines on specific settings, populations and conditions were excluded. The review was published online first Nov. 12 by Annals of Internal Medicine.

Researchers used 2 methods for evaluating the literature: the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument and A Measurement Tool to Assess Systematic Reviews (AMSTAR).

With AGREE II, appraisers rated 23 items across 6 domains, scored from 1 for strongly disagree to 7 for strongly agree. Scaled domain scores (0% to 100%) were based on the sum of ratings across all appraisers and the difference between the maximum and minimum possible scores. Using AGREE II, overall guideline assessment scores ranged from 3.00 to 6.20. Rigor-of-development scores were 20% to 84%, clarity-of-presentation scores ranged from 37% to 93%, applicability scores were 13% to 56%, and editorial independence scores ranged from 0% to 88%.

Ratings were highest for a guideline by the American Pain Society and the American Academy of Pain Medicine and for a guideline by the Canadian National Opioid Use Guideline Group. These were the only guidelines that more than half of the appraisers voted to use without modification. A majority of appraisers recommended against using 4 other guidelines because of limited confidence in development methods, lack of evidence summaries or concerns about readability.

In the original version of AMSTAR, appraisers answer 6 domain questions, which typically addressed multiple concepts. Using this system, systematic reviews within 10 guidelines were of poor or fair quality. The authors noted that the American Pain Society and the American Academy of Pain Medicine review was of excellent to outstanding quality, the review by the Canadian National Opioid Use Guideline Group was of good to excellent quality, and a review by the Department of Veterans Affairs and Department of Defense was of good quality.

Reasons for lower scores on other guidelines included limited information about whether inclusion criteria were selected beforehand, whether at least 2 reviewers participated in study selection and data extraction, whether more than 1 database was searched, search terms used, inclusion criteria, lists of included studies, whether the scientific quality of the studies was assessed, how information from different studies was combined, and whether publication bias was considered.

On mitigating opioid-related risks, a majority of the guidelines recommended that clinicians avoid doses greater than 90 to 200 mg of morphine equivalents per day, have additional knowledge to prescribe methadone, recognize risks of fentanyl patches, titrate cautiously, and reduce doses by at least 25% to 50% when switching opioids. Guidelines also agreed that opioid risk assessment tools, written treatment agreements, and urine drug testing can mitigate risks. Most recommendations were supported by observational data or expert consensus.

But, the review authors cautioned, few studies directly addressed questions of whether changing practices decreases risks of opioid use. "Given the pressing need to address opioid-related adverse outcomes, which some have described as an epidemic, developers seem to agree on forging recommendations based on relatively weak or indirect evidence now rather than waiting for more rigorous studies," they wrote.

"SAFE Opioid Prescribing," a free online training program to educate clinicians about safety and efficacy when prescribing opioids, was recently launched by ACP and its curriculum partner Pri-Med. The program is available on the Pri-Med website and is a REMS-compliant training program eligible for up to 6 hours of category 1 CME.


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Gabapentin reduced drinking, cravings, sleep and mood problems in alcoholics

Treatment with gabapentin reduced alcohol consumption and relapse-related symptoms in patients with alcohol dependence, a recent single-center study found.

The 12-week, double-blind trial ran from 2004 to 2010 at 1 outpatient research facility and randomized 150 men and women with alcohol dependence to placebo, 900 mg of gabapentin daily or 1,800 mg of gabapentin daily, along with counseling. Outcomes were rates of complete abstinence and no heavy drinking and changes in mood, sleep and craving. Results were published by JAMA Internal Medicine on Nov. 4.

Gabapentin, especially the higher dose, significantly increased abstinence over the 12 weeks. Rates were 4.1% on placebo (95% CI, 1.1% to 13.7%), 11.1% on the lower dose (95% CI, 5.2% to 22.2%) and 17.0% in the higher-dose group (95% CI, 8.9% to 30.1%) (P=0.04 for linear dose effect). A similar pattern was seen in the percentage of patients who refrained from heavy drinking (22.5% on placebo, 29.6% on 900-mg gabapentin, and 44.7% on 1,800 mg; P=0.02 for linear dose effect). Mood, sleep and cravings also showed similar effects. The study had no serious drug-related adverse events, and discontinuation rates were similar across groups.

The results indicate that gabapentin (particularly the 1,800-mg dose) was effective with a favorable safety profile and could facilitate increased pharmacological treatment of alcohol dependence in primary care, the study authors concluded. They acknowledged that the study was limited by a high dropout rate (although one equivalent to similar studies), its use of a single center, and inclusion only of patients who could refrain from drinking for 3 days before starting gabapentin. Future studies should test this treatment in larger, more diverse populations, the authors said.

An accompanying editorial noted that the use of anticonvulsants (specifically, topiramate) for alcohol dependence has been previously studied but that the adverse effect profile of gabapentin appears superior based on this study. A variety and possibly a combination of approaches may be the solution to treating this condition, the editorial said. In general, medications are underutilized in treatment for alcohol dependence, the editorialist wrote, urging primary care physicians to embrace "the mandate to recognize and treat alcoholism and other addictions."



Test yourself


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MKSAP Quiz: Pregnancy and a previous idiopathic pulmonary embolism

A 35-year-old woman undergoes evaluation after home pregnancy testing indicated that she is pregnant. Her medical history includes a previous idiopathic pulmonary embolism. Her only medication is a daily prenatal vitamin.

mksap.gif

On physical examination, temperature is 36.2 °C (97.1 °F), blood pressure is 110/65 mm Hg, pulse rate is 70/min, and respiration rate is 20/min. BMI is 25.

Results of a pregnancy test are positive.

Which of the following is the most appropriate venous thromboembolism prophylaxis for this patient?

A: Antepartum low-molecular-weight heparin (LMWH) and aspirin
B: Antepartum and postpartum LMWH
C: Antepartum and postpartum warfarin
D: No prophylaxis

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


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Men's health


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Testosterone therapy may be associated with increased risk of mortality and cardiovascular events

Testosterone therapy was associated with increased risk of mortality, myocardial infarction (MI) or ischemic stroke among men in the Veterans Administration (VA) health care system, a study found.

To assess the association between testosterone therapy and all-cause mortality, MI, or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease, researchers conducted a retrospective national cohort study of all men (n=23,173) who underwent coronary angiography in the VA system between 2005 and 2011 and who had testosterone levels less than 300 ng/dL.

Results appeared in the Nov. 6 Journal of the American Medical Association.

There was a high rate of comorbidities among the 8,709 men with low testosterone levels. About 20% had a prior MI, 50% had diabetes, and more than 80% had CAD. In the low testosterone group, 748 men died, 443 had MIs, and 519 had strokes. Of 7,486 patients who did not receive testosterone therapy, 681 died, 420 had MIs, and 486 had strokes.

There were 1,223 patients who started testosterone therapy following coronary angiography. Among this group, 67 died, 23 had MIs, and 33 had strokes. The absolute rate of events was 19.9% among those who didn't receive testosterone versus 25.7% in those who did. The absolute risk difference for events was 5.8% (95% CI, −1.4% to 13.1%) at 3 years after coronary angiography with absolute risk differences of 1.3% (95% CI, −7.1% to 9.7%) at 1 year and 3.1% (95% CI, −4.9% to 11.0%) at 2 years.

Cox proportional hazards models showed that testosterone therapy as a time-varying covariate was associated with increased risk of adverse outcomes (HR, 1.29; 95% CI, 1.04 to 1.58) but that there was no significant difference in the effect size of testosterone therapy between patients with and without CAD (test for interaction, P=0.41). These findings from this observational study may raise concerns about the potential safety of testosterone therapy, the authors said.

"Although physicians should continue to discuss the symptomatic benefits of testosterone therapy with patients, it is also important to inform patients that long-term risks are unknown and there is a possibility that testosterone therapy might be harmful," they wrote. "Randomized clinical trials and observational studies in other populations are needed to help inform whether long-term testosterone therapy use is safe or if it is associated with adverse cardiovascular events."

An editorialist pointed out that the VA study population had more comorbidities than men enrolled in most randomized clinical trials. In addition, there was little information about whether testosterone was prescribed according to guidelines. This brings into question the generalizability of the results to the broader population of men taking testosterone, whether for "low T," antiaging purposes or physical enhancement.

The editorialist wrote, "In light of the high volume of prescriptions and aggressive marketing by testosterone manufacturers, prescribers and patients should be wary. There is mounting evidence of a signal of cardiovascular risk, to which [this study] contributes. This signal warrants both cautious testosterone prescribing and additional investigation."



Hypertension


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Tailoring antihypertensive treatment to cardiovascular benefits may improve outcomes

Tailoring antihypertensive treatment to cardiovascular benefits rather than specific blood pressure targets may improve outcomes and result in less medication use, according to a new study using simulation models.

Researchers used data from the National Health and Nutrition Examination Survey III to develop a nationally representative sample of U.S. adults who were 30 to 85 years of age and had no history of myocardial infarction, stroke or severe congestive heart failure. They created a simulation model that would estimate the effect of 5 years of antihypertensive treatment based on specific blood pressure goals and 5 years of treatment based on estimated reduction in cardiovascular disease (CVD) events. Meta-analyses of randomized trials were used to derive estimates of effect size, and the researchers determined how many quality-adjusted life-years (QALYs) would be saved by using each treatment strategy.

In the base-case treat-to-target strategy, patients received new blood pressure medication if the observed blood pressure was 140/90 mm Hg or higher (130/85 or higher for diabetic patients). Medications were then added on a sequential basis until patients were taking 4 medications or until the target blood pressure was reached. In the benefit-based strategy, patients moved to the next stage of therapy if they had an observed systolic blood pressure above 150 mm Hg or if it was predicted that their rate of CVD events would decrease by more than a 1.7% chance of an event averted over 5 years of therapy (that is, patients got a new medication if it was deemed highly likely to prevent a CVD event). Patients were then assessed in a Markov model, and QALYs lost per event were estimated. In the primary analysis, patients treated with the treat-to-target strategy were compared with those treated using the benefit-based strategy. The study was published early online Nov. 4 by Circulation.

Overall, the model estimated that 55% of 176 million Americans would receive the same treatment regardless of which approach was used and that 45% would receive different treatments. A total of 26.5% of the total population would receive more intensive treatment with the treat-to-target strategy, resulting in an additional 1.9 medications per person and 204 QALYs saved per 1,000 people treated for 5 years. A total of 18.7% of the total population would receive more intensive treatment with the benefit-based strategy, resulting in 2.5 medications per person and 487 QALYs saved per 1,000 people treated for 5 years. In the 55% of patients who received the same treatment regardless of approach, benefit-based treatment was estimated to prevent approximately 900,000 CVD events, save 2.8 million additional QALYs and use 6% fewer medications over 5 years. In the 45% of patients who received different treatments based on the approach used, benefit-based treatment was estimated to save 159 QALYs per 1,000 treated patients versus 74 QALY per 1,000 patients treated to target.

The authors acknowledged that their study was limited by the available evidence, that simulation models should always be interpreted with caution, and that they were not making global recommendations about treatment intensity. They also noted that determining potential net benefit using untreated cardiovascular risk, blood pressure and current treatment regimen would be difficult for physicians to do on their own and that their model would need to be incorporated into electronic medical records or made available online for ease of calculation. However, they concluded that their results suggest more effective prevention of CVD events when antihypertensive treatment is based on potential benefit.

The authors of an accompanying editorial called the study timely and noted that it, together with previous research, supports the idea of treating hypertension based on cardiovascular risk. However, they called for further research to evaluate the potential effects of such changes in strategy. "The case to move on from blood pressure targets to risk-based targets is (and has always been) compelling," they wrote. "But bringing about actual change in the clinic requires much more work. An important part of this involves the development of innovative strategies by which to more effectively incorporate risk-based management approaches into usual clinical practice."



Guidelines


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New recommendations on diagnosis and treatment of Bell's palsy

Recommendations on diagnosing and treating Bell's palsy were recently provided by a new clinical practice guideline from the American Academy of OtolaryngologyHead and Neck Surgery Foundation.

The guideline is intended to improve diagnosis, quality of care and outcomes for Bell's palsy patients and decrease harmful variation in the evaluation and management of the condition. In a clinical practice guideline summary, the recommendations were summarized as a list of key action statements:

  • Clinicians should assess the patient using history and physical examination to exclude identifiable causes of facial paresis or paralysis in patients presenting with acute-onset unilateral facial paresis or paralysis.
  • Clinicians should not obtain routine laboratory testing in patients with new-onset Bell's palsy.
  • Clinicians should not routinely perform diagnostic imaging for patients with new-onset Bell's palsy.
  • Clinicians should prescribe oral steroids within 72 hours of symptom onset for Bell's palsy patients 16 years and older.
  • Clinicians should not prescribe oral antiviral therapy alone for patients with new-onset Bell's palsy but may offer oral antiviral therapy in addition to oral steroids within 72 hours of symptom onset.
  • Clinicians should implement eye protection for Bell's palsy patients with impaired eye closure.
  • Clinicians should not perform electrodiagnostic testing in Bell's palsy patients with incomplete facial paralysis but may offer electrodiagnostic testing to those with complete facial paralysis.
  • Clinicians should reassess or refer to a facial nerve specialist those Bell's palsy patients with new or worsening neurologic findings at any point, ocular symptoms developing at any point, or incomplete facial recovery 3 months after initial symptom onset.
  • No recommendation could be made regarding the effects of surgical decompression, acupuncture or physical therapy for Bell's palsy patients, the guideline concluded.

The recommendations were developed by a panel of otolaryngologyhead and neck surgeons, neurologists, facial plastic and reconstructive surgeons, neurotologists, otologists, emergency medicine and primary care professionals, nurses and physician assistants and consumer advocates. The full guideline was published Nov. 4 in Otolaryngology–Head and Neck Surgery.



CMS update


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CMS confirms payment rules will be issued in November

The recent federal government shutdown had caused some concern that CMS would not be able to issue its year-end final rules in time.

This week the agency confirmed that the calendar year 2014 rules will be issued on or before Nov. 27, with the normal effective date of Jan. 1. In addition to the Physician Fee Schedule these rules will include: End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (CMS-1526-F); CY 2014 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (CMS-1601-FC); and CY 2014 Home Health Prospective Payment System Final Rule (CMS-1450-F).


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2012 PQRS feedback reports available

Reports are now available for physicians who participated in the 2012 Physician Quality Reporting System (PQRS).

Access instructions and information on locating and interpreting the feedback report data can be found in the 2012 PQRS Feedback Report User Guide. More information about PQRS and how to participate can be found on the Running a Practice Section of the ACP website.



From ACP Internist


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ACP Internist's latest edition is online and coming to your mailbox

The November/December edition of ACP Internist features the following stories:

acpi-20131112-internist.jpg

Patients increasingly checking 'Dr. Google'. More than a third of patients have gone online to identify a medical condition, raising concerns about "cyberchondria" and requiring physicians to adapt to help patients use these websites in productive ways.

Coping skills, counseling best for low back pain. Despite all the best evidence and guidelines, patients with low back pain are still spending time, effort and money on things that aren't helping them in the long run.

Doctors have an online presence, even if they don't know it yet. Patients are using physician rating websites to find their doctors and find out more about them. ACP Member Kevin Pho, MD, of KevinMD.com, explains why doctors need a plan in place to make sure that accurate and positive information makes its way to the top of a search engine.

More stories, the latest Test Yourself with the MKSAP Quiz, and our latest opinion poll on whether physicians have had patients present them with online medical information are now online.



From the College


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ACP LEAD transition deadline reminder

College members currently pursuing an ACP Leadership Enhancement and Development (LEAD) Certificate must declare their intent to complete the requirements by e-mailing ACP at LEAD@acponline.org by Dec. 31, 2013. To earn a LEAD certificate, physicians must participate in 5 out of 7 LEAD activities and complete an application by June 30, 2014.

In partnership with the American College of Physician Executives (ACPE), the ACP Leadership Academy, ACP's new leadership development program designed to provide early career internists with the skills and knowledge necessary to become leaders in medicine, is replacing ACP's LEAD program.

Former ACP LEAD certificate recipients and ACP members who have completed some but not all of the requirements for a LEAD certificate may transfer up to 22 credits toward completion of the prerequisites for ACPE's certificate by June 30, 2014. To determine how many credits you may transfer, please e-mail ACP at LEAD@acponline.org by Dec. 31, 2013. Applications for ACP's LEAD certificate or transfer of credits will not be accepted after this date.

For more information, on the ACP Leadership Academy and LEAD transition information, visit the program website.



Cartoon caption contest


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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-20131112-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.


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MKSAP Answer and Critique



The correct answer is B: Antepartum and postpartum LMWH. This item is available to MKSAP 16 subscribers as item 43 in the Hematology and Oncology section. More information is available online.

This patient should receive antepartum and postpartum heparin. Patients such as this one with a previous history of idiopathic venous thromboembolism (VTE) are at a fourfold increased risk for recurrent VTE compared with patients with a history of triggered VTE. Although outcomes data are limited, it is currently recommended that pregnant women at moderate to high risk of recurrent VTE (as in this patient with a single unprovoked pulmonary embolism) receive prophylactic-dose or intermediate-dose low-molecular-weight heparin (LMWH) during pregnancy and for 6 weeks postpartum.

Prophylaxis with both low-dose aspirin and low- or moderate-dose unfractionated heparin or LMWH is indicated for women with recurrent fetal loss and the antiphospholipid syndrome. This patient does not have the antiphospholipid syndrome or previous fetal loss, and combined aspirin and heparin treatment is not indicated.

Warfarin is contraindicated during the first trimester because of the potential for warfarin-induced embryopathy. In addition, warfarin is rarely used in the United States during the second and third trimesters, generally because of the fear of liability in the event of any fetal adverse events, whether or not they are warfarin related.

Administering no prophylaxis to this patient with a high risk for recurrent VTE would not be prudent.

Key Point

  • Pregnant women with a history of idiopathic venous thromboembolism should receive antepartum and postpartum prophylactic anticoagulation.

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Test yourself

A 63-year-old man is evaluated for pleuritic left-sided anterior chest pain, which has persisted intermittently for 1 week. The pain lasts for hours at a time and is not provoked by exertion or relieved by rest but is worse when supine. He reports transient relief with acetaminophen and codeine and occasionally when leaning forward. He has had a low-grade fever for 3 days, without cough or chills. Medical history is significant for acute pericarditis 7 months ago. Following a physical exam and electrocardiogram, what is the most appropriate management?

Find the answer

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