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

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ACP InternistWeekly



In the News for the Week of 1-10-12




Highlights

New analyses differ on whether dabigatran raises MI risk

Two analyses published in the past week compared rates of myocardial infarction (MI) in patients taking dabigatran or warfarin and came to differing results. More...

ACIP recommends hepatitis B vaccine for diabetics, HPV vaccine for men

Two new recommendations from the Advisory Committee on Immunization Practices (ACIP) outline hepatitis B vaccination for diabetic adults and human papillomavirus vaccination in males ages 9 to 26. More...


Test yourself

MKSAP Quiz: 6-month history of diffuse muscle and joint pain

This week's quiz asks readers to evaluate a 25-year-old woman with a 6-month history of diffuse muscle and joint pain, fatigue, and difficulty sleeping. More...


Cardiology

Drug-eluting stents associated with benefits in patients age 85 and older

Drug-eluting stents are being used less often in elderly patients, even though their use is associated with better outcomes in these patients, a new study found. More...


Pain management

Spinal manipulation, home exercise found to be better than medication for neck pain

Twelve weeks of spinal manipulation therapy led to greater relief from neck pain than medication up to one year after treatment, and home exercise with advice offered about the same relief as either treatment. More...


CMS update

CMS extends 2012 Annual Participation Enrollment Period

At the end of December, CMS announced that it would be extending the Annual Participation Enrollment Period through Feb. 14. More...

CMS delays version 5010 enforcement, offers resources

CMS has announced that it will not enforce version 5010 compliance for 90 days after the Jan. 1 compliance date. More...


From ACP Internist

The next issue of ACP Internist is online and coming to your mailbox

The January issue of ACP Internist includes stories on politics and medicine and antidepressants in primary care, as well as a new column on framing risk and benefits of treatments. More...


From the College

New College resource analyzes health platforms of presidential candidates

The 2012 presidential election is underway, and the leading candidates have begun to release details about their proposals relating to health care in the U.S. More...

ACP releases updated Ethics Manual

ACP has released the sixth edition of the Ethics Manual, published as a supplement with the Jan. 3 Annals of Internal Medicine. More...

ACP's PQRIwizard now available

ACP's new PQRIwizard, an online tool designed to help collect and report quality measure data for the Centers for Medicare and Medicaid Services (CMS) PQRS incentive payment program, is now available. More...

Making transitions better for patients

Fred Ralston Jr., MD, MACP, ACP's immediate past president and a practicing internist in Fayetteville, Tenn., writes at KevinMD.com this month about improving transitions of care. More...

Call for fall 2012 Board of Governors resolutions

The deadline for submitting new resolutions to be heard at the fall 2012 Board of Governors meeting is Monday, May 21, 2012. More...

Governor election results for the Class of 2017

The Governors' Subcommittee on Nominations is pleased to announce the Governor-elect Designees (GEDs) for a number of chapters. More...


Cartoon caption contest

And the winner is …

ACP InternistWeekly has tallied the voting from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption. More...

Editorial note: ACP InternistWeekly will not be published next week due to the Martin Luther King Jr. Day holiday.


Physician editor: Darren Taichman, MD, FACP



Highlights


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New analyses differ on whether dabigatran raises MI risk

Two analyses published in the past week compared rates of myocardial infarction (MI) in patients taking dabigatran or warfarin and came to differing results.

Initial reports from the RE-LY trial had indicated that in patients with atrial fibrillation, dabigatran could be associated with an elevated rate of MI, although a post-publication reanalysis authorized by the FDA concluded that the difference was not significant. In a new analysis published online by Circulation on Jan. 3, researchers used data from RE-LY to specifically compare rates of MI, unstable angina, cardiac arrest and cardiac death between patients taking dabigatran and those on warfarin. They found that MI occurred in 98 patients on 110 mg of dabigatran, 97 patients on 150 mg of dabigatran, and 75 patients on warfarin. This worked out to annual event rates of 0.82%, 0.81% and 0.64%, a nonsignificant difference (P ≥0.09 for comparison between dabigatran and warfarin).

The analysis also compared the drugs on the composite of adverse events (MI, unstable angina, cardiac arrest, cardiac death), and found annual rates of 3.16% with 110 mg of dabigatran, 3.33% for 150 mg of dabigatran and 3.41% for warfarin, also a nonsignificant difference. When the outcome was expanded to include strokes, systemic embolism, pulmonary embolism, major bleeding and all-cause death (which were the pre-specified events included in the RE-LY trial), annual rates were 7.34% for 110 mg of dabigatran, 7.11% for 150 mg of dabigatran and 7.91% for warfarin. The researchers also divided patients by presence or absence of history of coronary artery disease or MI, and they found no difference in the relative effects of the drugs.

Based on the results, the authors concluded that dabigatran was associated with a nonsignificant increase in MI compared to warfarin, but no increase in other myocardial ischemic events. However, they cautioned that the RE-LY trial was not powered to detect a difference in rates of MI between the various treatments, and that the outcomes included in this analysis were not prespecified. Still, given that dabigatran was associated with lower rates of the combined outcomes measured by the RE-LY trial, any possible increase in MI is likely to be outweighed by the other benefits of the drug, the authors concluded.

However, a meta-analysis published online by Archives of Internal Medicine on Jan. 9 concluded that dabigatran was associated with a significantly higher risk of MI and acute coronary syndrome (ACS). This analysis combined data from the RE-LY trial with six other trials comparing dabigatran with warfarin, enoxaparin, or placebo for stroke prophylaxis, ACS, acute venous thromboembolism and short-term prophylaxis of deep venous thrombosis. Overall, patients on dabigatran had significantly more cases of MI or ACS than those taking any of the other drugs (dabigatran, 237 events in 20,000 patients [1.19%] vs. control, 83 events in 10,514 patients [0.79%]; odds ratio, 1.33; P=0.03). The authors noted that the mechanism behind this association is unknown. They speculated, "Dabigatran might not directly increase the risk of MI, but it may lack the beneficial effects that warfarin and aspirin have in MI prevention." They agreed with the authors of the first analysis that for patients with atrial fibrillation, the stroke prevention effects of dabigatran make it beneficial overall. However, they called for further investigation of the drug's possible cardiac risks.



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ACIP recommends hepatitis B vaccine for diabetics, HPV vaccine for men

Two new recommendations from the Advisory Committee on Immunization Practices (ACIP) outline hepatitis B vaccination for diabetic adults and human papillomavirus vaccination in males ages 9 to 26.

Both recommendations appeared in the Dec. 23, 2011 Morbidity and Mortality Weekly Report.

Hepatitis B vaccination should be administered to all diabetics ages 19 through 59 (evidence type 2, randomized controlled trials with important limitations, or exceptionally strong evidence from observational studies).

Vaccination should be completed as soon as possible after a diabetes diagnosis, but no vaccine, dose or schedule conferred an advantage over another in the evidence. Hepatitis B vaccine may be given during visits scheduled for other reasons as long as minimum intervals between doses are observed. There is no maximum interval between doses that makes the hepatitis B vaccination series ineffective, the ACIP said. No serologic testing or additional hepatitis B vaccination is recommended for adult diabetics who have already received a complete vaccination series.

The hepatitis B vaccination series can be given safely at any age, but current hepatitis B vaccines are less efficacious and less cost-effective among older adults, the experts said. Thus they recommended that hepatitis B vaccination may be given at a clinician's discretion in diabetics older than age 60 (evidence type 2). Clinicians should consider the patient's likelihood of acquiring hepatitis B (including the risk posed by an increased need for assisted blood glucose monitoring in long-term care facilities), the likelihood of experiencing chronic sequelae if infected, and the declining immunologic responses to vaccines that are associated with frailty.

According to economic models, the incremental cost per quality-adjusted life-year (QALY) saved from vaccinating adults with diabetes was $75,100 for those ages 20 through 59 but increased substantially after age 60.

HPV4 was licensed in 2009 for use in males to prevent genital warts. The FDA added prevention of anal cancer in males and females as an indication for use in December 2010. For HPV vaccination in men, the ACIP recommends routine vaccination of males ages 11 or 12 years with HPV4 administered as a three-dose series (evidence type 2). Vaccination with HPV4 is also recommended for males ages 13 through 21 who have not already been vaccinated or who have not received all three doses in the series. Vaccination may be administered in men ages 22 through 26 years. Recommendations for administration and precautions have not changed from previous recommendations.

At the current vaccine price, adding male vaccination at age 12 years to a female-only vaccination strategy would cost approximately $20,000 to $40,000 per QALY in more favorable models and approximately $75,000 to more than $250,000 per QALY in less favorable models. Vaccination of adult males becomes less cost-effective as age at vaccination increases, and models suggest the cost per QALY gained by vaccinating males older than 21 years would be about two to four times that of vaccinating teenage males.



Test yourself


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MKSAP Quiz: 6-month history of diffuse muscle and joint pain

A 25-year-old woman is evaluated during a follow-up visit for a 6-month history of diffuse muscle and joint pain above and below the waist, fatigue, and difficulty sleeping. She has a 2-year history of hypothyroidism treated with levothyroxine. Her only other medication is hydrocodone-acetaminophen, which has not relieved her pain.

mksap.jpg

On physical examination, temperature is 37.0 °C (98.6 °F), blood pressure is 125/78 mm Hg, pulse rate is 85/min, and respiration rate is 12/min. Cardiopulmonary examination is normal. Musculoskeletal examination reveals diffuse periarticular tenderness, including bilateral tenderness in the biceps brachii, thighs, and calves. Muscle strength testing cannot be completed because of pain. The joints are not swollen, and she does not have lower-extremity edema.

Laboratory studies:

Complete blood count Normal
Complete metabolic panel Normal
Erythrocyte sedimentation rate 10 mm/h
Creatine kinase 100 U/L
Antinuclear antibodies Titer of 1:640
Thyroid-stimulating hormone 1.5 µU/mL (1.5 mU/L)
Urinalysis Normal

Which of following is the most likely diagnosis?

A) Fibromyalgia
B) Polymyositis
C) Sjögren syndrome
D) Systemic lupus erythematosus

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


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Cardiology


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Drug-eluting stents associated with benefits in patients age 85 and older

Drug-eluting stents are being used less often in elderly patients, even though their use is associated with better outcomes in these patients, a new study found.

The observational study included more than 400,000 patients who underwent percutaneous coronary intervention (PCI) at 65 years of age or older. Claims data for these patients were collected between 2004 and 2008, and long-term outcomes were compared between patients who received drug-eluting and bare-metal stents. The results were published in the Jan. 10 Journal of the American College of Cardiology.

Researchers found that use of drug-eluting stents in patients 65 and over declined after 2005, with the greatest decline seen in patients age 85 and over. Overall, however, these very elderly patients comprised an increasing percentage of PCIs performed after age 65 (perhaps because periprocedural anticoagulants have reduced the risk of complications, researchers speculated).

In the study population, drug-eluting stents were associated with lower mortality than bare-metal ones, an effect that after adjustment decreased with increasing age (≥85 years, 29% mortality vs. 38%, hazard ratio [HR], 0.80; 75 to 84 years, 17% vs. 25%, HR, 0.77; 65 to 74 years, 10% vs. 16%, HR, 0.73). However, the oldest patients got greater benefit than their younger peers from drug-eluting stents on the outcome of myocardial infarction rehospitalization (≥85 years, 9% vs. 12%, HR, 0.77; 75 to 84 years, 7% vs. 9%, HR, 0.81; 65 to 74 years, 7% vs. 8%, HR, 0.84). In contrast to previous research, the study did not find a lower risk of repeat revascularization associated with drug-eluting stents.

Based on the results, physicians may want to consider use of drug-eluting stents in elderly patients, the authors said. Treatment goals for these patients may be different than for younger patients; for example, maximizing quality of life by avoiding rehospitalization could be more important than reducing repeat revascularization, the researchers noted. The study was limited by its observational design, so future research should further compare PCI treatments in the elderly, focusing on endpoints relevant to these patients, they concluded.



Pain management


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Spinal manipulation, home exercise found to be better than medication for neck pain

Twelve weeks of spinal manipulation therapy (SMT) led to greater relief from neck pain than medication up to one year after treatment, and home exercise with advice (HEA) offered about the same relief as either treatment.

Researchers conducted a randomized, controlled trial among 272 people with symptoms of mechanical, nonspecific neck pain equivalent to grades I or II according to the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders classification, current neck pain of 2 to 12 weeks' duration, and a neck pain score of 3 or greater on a scale of 0 to 10. Participants were asked to refrain from seeking additional treatment for neck pain outside the study during the 12-week intervention.

annals.jpg

This group was then randomized to 12 weeks of SMT (n=90), medication (n=91), or HEA (n=91). The first line of therapy for the medication group was nonsteroidal anti-inflammatory drugs, acetaminophen, or both. If participants did not respond to these drugs or could not tolerate them, they received narcotics. Muscle relaxants were also used. Participants and clinicians could not be blinded to treatments. Results appeared in the Jan. 3 Annals of Internal Medicine.

The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks. Improvement in participant-rated pain was significantly better with SMT compared with medication at 12 weeks (0.94 greater reduction in pain [95% CI, 0.37 to 1.51]; P=0.001) and in longitudinal analyses that incorporated pain ratings every 2 weeks from baseline to 12 weeks (0.55 greater reduction in pain [95% CI, 0.10 to 1.00]; P=0.017).

At 12 weeks, a significantly higher absolute proportion of the SMT group experienced pain reductions of at least 50%. Differences in participant-rated pain improvement between the SMT and HEA groups were smaller and not statistically significant. Differences between the HEA and medication groups were also not statistically significant, although a higher absolute proportion of the HEA group experienced pain reductions of at least 75% at 12 weeks compared with the medication group.

At 26 and 52 weeks, participant-rated pain improvement favored SMT over medication, but not SMT over HEA or HEA over medication, compared with baseline. A higher absolute proportion in the SMT group than in the medication group experienced reductions of pain of at least 50% at 26 but not 52 weeks.



CMS update


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CMS extends 2012 Annual Participation Enrollment Period

At the end of December, CMS announced that it would be extending the Annual Participation Enrollment Period through Feb. 14.

This extension gives physicians and other health care professionals extra time to decide on their Medicare participation status, but the effective date for any status change will be retroactive to Jan. 1, 2012 and the new status will remain in effect for the entire year. Additional information is online.


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CMS delays version 5010 enforcement, offers resources

CMS has announced that it will not enforce version 5010 compliance for 90 days after the Jan. 1 compliance date.

This change effectively moves the deadline to April 1. ACP strongly encourages its members to continue their version 5010 implementation programs as all health insurers, not just Medicare and Medicaid, will be transitioning to the new electronic transactions standards. Practices that do not successfully transition to version 5010 will find that their claims cannot be processed and therefore cannot be paid.

Additional information can be found in the Running a Practice section of the College's website.

CMS has also produced two new Web resources to help clinicians with questions about version 5010 and ICD-10. A new FAQ is available on the CMS website to answer questions about the transition to version 5010 currently taking place. Additionally, the agency has posted a slideshow about different strategies for ICD-10 implementation on the CMS YouTube channel.



From ACP Internist


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The next issue of ACP Internist is online and coming to your mailbox

Lawmakers try to 'script' what doctors say. State legislatures are drafting laws that would mandate what doctors tell their patients about culturally controversial topics such as abortion or guns in the home, or even purely clinical issues such as breast cancer. How involved should politicians be in the exam room?

acpi-20120110-internist.jpg

Antidepressants no easy fix in primary care. Is depression on the rise, or just prescribing for it? There's now an educational burden on internists to learn the proper role of medications in mental health.

Framing risk, benefits perilous for physicians and patients. A new column debuts, outlining how physicians can properly frame risks and benefits of treatments so patients can make the best medical decisions for themselves.

These stories and the latest Test Yourself with MKSAP question on a six-week history of cough are online, as is an obituary for former ACP Regent and ACP Internist editorial board member Richard Neubauer, MD, MACP.



From the College


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New College resource analyzes health platforms of presidential candidates

The 2012 presidential election is underway, and the leading candidates have begun to release details about their proposals relating to health care in the U.S.

Analysis of the health proposals of the major candidates and how they compare to ACP policy is now available on the advocacy section of the College's website. In the Election 2012 section, members will also find information about how to get involved and why it's important for internists to engage in the political process.


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ACP releases updated Ethics Manual

ACP has released the sixth edition of the Ethics Manual, published as a supplement with the Jan. 3 Annals of Internal Medicine.

The updated manual revisits and expands on topics featured in previous editions such as end-of-life care, complementary and alternative medicine, physician-assisted suicide, physician-industry relations, genetic testing, and research ethics. New topics in the updated manual address the patient-physician relationship during health catastrophes, provision of culturally sensitive care, use of human biologic materials in research, social media and online professionalism, industry-sponsored research, and the challenges of caring for so-called very important persons, such as those with a degree of fame or prestige.

As an added bonus for ACP members and subscribers to Annals of Internal Medicine, a continuing medical education (CME) quiz and maintenance of certification (MOC) module are available online along with the manual.


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ACP's PQRIwizard now available

ACP's new PQRIwizard, an online tool designed to help collect and report quality measure data for the Centers for Medicare and Medicaid Services (CMS) PQRS incentive payment program, is now available.

Similar to online tax preparation software, the PQRIwizard guides health care professionals through a few easy steps to help rapidly collect, validate, report, and submit the results to CMS for payment. The deadline for reporting for the year 2011 is Feb. 17, 2012, so there's time if you act quickly. The PQRIwizard is powered by the CECity Registry® for PQRS reporting. ACP has partnered with CECity to allow members to purchase the PQRIwizard for a discounted rate of $219. Learn more about this tool online.


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Making transitions better for patients

Fred Ralston Jr., MD, MACP, ACP's immediate past president and a practicing internist in Fayetteville, Tenn., continues his monthly column at KevinMD.com, one of the Web's leading destinations for provocative physician commentary.

This month's post looks at how physicians can improve transitions to make patient care better.


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Call for fall 2012 Board of Governors resolutions

The deadline for submitting new resolutions to be heard at the fall 2012 Board of Governors meeting is Monday, May 21, 2012. Initiating a resolution provides ACP members an opportunity to focus attention at the ACP national level on a particular issue or topic that concerns them. When drafting a resolution, don't forget to consider how well it fits within ACP's Mission and Goals. In addition, be sure to use the College's Strategic Plan to guide you when proposing a resolution topic. Members must submit resolutions to their Governor and/or chapter council. A resolution becomes a resolution of the chapter once the chapter council approves it.

In accordance with the ACP Board of Governors Resolutions Process, resolutions should clearly distinguish the action requested within its resolved clause(s) as either a policy resolve ("Resolved that ACP policy…"), or a directive, which requests action/study on an issue ("Resolved that the Board of Regents…"). If more than one action is proposed, each should have its own resolved clause. Members should contact their Governors if they have any questions regarding the resolution format.

The Board of Governors votes on new resolutions, which are then presented to the Board of Regents for action. Members are encouraged to use the Electronic Resolutions System (ERS) to research the status of past resolutions before proposing a new resolution. Visit your chapter website and link to the ERS under the "Advocacy" heading.


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Governor election results for the Class of 2017

The Governors' Subcommittee on Nominations is pleased to announce the Governor-elect Designees (GEDs) for the chapters below. The GEDs will start their year-long terms as Governors-elect at the conclusion of the Annual Business Meeting in April 2012. Their four-year terms as Governors will begin at the Annual Business Meeting in April 2013 and end at the same meeting in 2017.

Alaska Chapter: Molly B. Southworth, MD, MPH, FACP

Arizona Chapter: James V. Felicetta, MD, FACP

California Northern Chapter: Gordon L. Fung, MD, FACP

California Southern Region III Chapter: Howard V. Williams, MD, FACP

Colorado Chapter: Christina M. Reimer, MD, FACP

Connecticut Chapter: Robert J. Nardino, MD, FACP

Hawaii Chapter: Mary Ann S. Antonelli, MD, FACP

Illinois Southern Chapter: Janet A. Jokela, MD, FACP

Mississippi Chapter: Dan M. Woodliff, MD, FACP

New York Long Island Chapter: Nick Fitterman, MD, FACP

Oregon Chapter: Thomas G. Cooney, MD, MACP

Tennessee Chapter: Richard G. Lane, MD, FACP

Texas Northern Chapter: Sue S. Bornstein, MD, FACP

Utah Chapter: Robert C. Pendleton, MD, FACP

Venezuela Chapter: Aquiles R. Salas, MD, FACP

U.S. Army Region: Surgeon General will appoint Governor-elect at later date.



Cartoon caption contest


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And the winner is …

ACP InternistWeekly has tallied the voting from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption.

acpi-20120110-cartoon.jpg

"Sir, it appears that you may have Bieber fever."

This issue's winning cartoon caption was submitted by ACP Associate Member Chelsea Martin, MD, from Augusta, Ga. Readers cast 113 ballots online to choose the winning entry. Thanks to all who voted! The winning entry captured 60.2% of the votes.

The runners-up were:

"Nooobody knooows, what's troublin' my spleen ..."

"Don't tell my heart, my achy breaky heart ..."


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MKSAP Answer and Critique



The correct answer is A) Fibromyalgia. This item is available to MKSAP 15 subscribers as item 30 in the Rheumatology section. More information about MKSAP 15 is available online.

This patient most likely has fibromyalgia. This condition is characterized by diffuse pain on both sides of the body and above and below the waist as well as axial skeletal pain, or, according to the original American College of Rheumatology criteria, the presence of pain in at least 11 of 18 specified potential tender points. However, expert opinion now states that these tender points are arbitrary and not essential in the diagnosis of fibromyalgia.

Most patients with this condition have fatigue and sleep disturbance. Fibromyalgia also may be associated with dry eyes and mouth. Studies that have assessed the comorbidity of fibromyalgia with other symptom-defined syndromes have found high rates of chronic fatigue syndrome, migraine, irritable bowel syndrome, pelvic pain, and temporomandibular joint pain in patients with fibromyalgia.

Polymyositis may manifest as muscle pain and fatigue but is unlikely in the absence of significant proximal muscle weakness or an elevated creatine kinase level.

Up to 25% of patients with systemic inflammatory conditions, such as systemic lupus erythematosus (SLE) and rheumatoid arthritis, have symptoms consistent with fibromyalgia in the initial stages of their illness. This patient's fatigue, polyarthralgia, dry eyes and mouth, and strongly positive titers of antinuclear antibodies are consistent with SLE and Sjögren syndrome. However, patients with SLE usually have anemia, leukopenia, or lymphopenia. Similarly, joint involvement in Sjögren syndrome typically manifests as inflammatory arthritis. Furthermore, patients with SLE and Sjögren syndrome may have systemic manifestations, including cutaneous, neurologic, and renal involvement, which are absent in this patient.

The presence of antinuclear antibodies is not diagnostic of SLE or Sjögren syndrome. These antibodies are often present in the general population and particularly in patients with autoimmune thyroid disease or in first-degree relatives of patients with SLE. In addition, high titers of antinuclear antibodies do not necessarily indicate the presence of autoimmune disease.

Key Point

  • Fibromyalgia is characterized by diffuse pain on both sides of the body and above and below the waist as well as axial skeletal pain.

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Test yourself

A 66-year-old man comes for a preoperative evaluation before total joint arthroplasty of the left knee. He has a 25-year history of rheumatoid arthritis. He has had progressive pain in his left knee with activity, which limits his ability to hike. The patient has similar pain in the right knee, but it is less severe. He reports no recent morning stiffness. He is able to climb two or three flights of stairs without chest pain or shortness of breath. He has no other medical problems and reports no additional symptoms. Medications are methotrexate and folic acid. Following a physical exam and lab tests, what is the next best step in management?

Find the answer

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