Informatics Center Knowledge Management / Eskind Biomedical Library Geriatrics Evidence Alert

Geriatrics Evidence Alert
November 2008


The Geriatrics Evidence Alert is an electronic newsletter developed by the Outpatient Clinical Informatics Consult Service (OCICS) at the Eskind Biomedical Library to provide a monthly update of selected evidence-based biomedical literature and recently published news and research to clinicians and other health professionals who provide clinical services for older adults at Vanderbilt University Medical Center and the Middle Tennessee area.

In this issue...


  1.  Clinical questions recently sent to the EBM Literature Request message basket in StarPanel
  2.  Clinical Practice Guidelines
  3.  Newly Published Research
  4.  FDA News & Safety Advisories

DISCLAIMER: The Informatics Center Knowledge Management / Eskind Biomedical Library Geriatrics Evidence Alert is a current awareness tool prepared solely for informational purposes for the convenience of the clinician and other healthcare professionals. Librarians at the Eskind Biomedical Library attempt to provide accurate, inclusive, and informative reports. The information provided in the alert is not a substitute for clinical judgment. Biomedical practitioners should therefore take careful consideration of the original evidence presented in the full-text of the articles cited before taking action. This educational material is produced with the support of the Vanderbilt-Reynolds Geriatrics Education Center.




  1. Clinical questions recently sent to the EBM Literature Request message basket in StarPanel

    Evidence suggests mental exercises may maintain cognitive thinking skills for specific tasks by elderly patients

    Question: What is the effect of applying higher-level thinking recreational and leisurely activities, such as word puzzles, brainteasers, and games, on improving or maintaining cognitive skills in later life in elderly persons with either normal or impaired cognition?

    Bottom Line: The evidence is fairly heterogeneous due to variance in study outcomes measured. However, a review of the literature found several studies that seem to fairly consistently report that patients perform better on measures of a specific cognitive task or ability for which they were assigned and trained and that this learning may last several years; however, performance with each intervention may not generalize to everyday performance. Less is known about its effects on performance in patients at risk for dementia in later life. [full text »]


    Evidence for adding low-dose aspirin to warfarin therapy in artificial heart valve patients

    Question: I was informed by his insurance company that new guidelines for prevention of clots/emboli on artificial heart valves included adding low-dose aspirin to full warfarin anticoagulation. Of course this is more risky than warfarin alone so far as bleeding goes. What is the evidence for this recommendation?

    Bottom Line: Included in this summary are two meta-analyses (Massel, 2001; Larson, 2004) analyzing randomized controlled trials, which evaluate the safety and efficacy of adding aspirin to warfarin in patients with mechanical heart valves. Both studies recommend the addition of aspirin to warfarin therapy in reducing the risk of mortality and thromboembolic events. Due to aspirin's association with increased risk of hemorrhage, Massel et al suggests the use of low-dose aspirin. Also included in the summary is a randomized trial by Trudie et al (1993) as it is an oft-cited article, investigating the addition of low-dose aspirin (100 mg/day) to warfarin in mechanical valve patients. According to the authors, this combination therapy significantly reduced the risk of mortality and thromboembolic events. While bleeding events occurred significantly more frequently in those taking aspirin compared to the placebo group, the number of major bleeding events did not differ significantly between the two groups. [full text »]


    Consenting patients with cognitive impairment for surgical procedures

    Question: Is there any standardization for consenting patients for procedures when there is some cognitive impairment? If a patient is mildly impaired and risk is minimal, can they consent? Are there standards for assessing capacity to consent for procedures?

    Bottom Line: In a recent New England Journal of Medicine article on assessment of patients' competence to consent to treatment, Dr. Paul Appelbaum, an expert from the Division of Law, Ethics, and Psychiatry in the College of Physicians and Surgeons at Columbia University reports, “There are currently no formal practice guidelines from professional societies for the assessment of a patient's capacity to consent to treatment” (Appelbaum, 2007). A search of core biomedical literature databases and web sites of professional organizations related to geriatrics, cardiology, and ethics confirmed this finding. Very few research studies were located that addressed decision-making capacity and informed consent for surgical procedures in particular. Some that were located are outlined in the table below along with other selected studies. [full text »]


For Vanderbilt University Medical Center physicians: To submit a complex clinical question via StarPanel for searching and synthesis of the medical literature, select the message basket link entitled EBM Literature Request located below the message box (also in each of the four VIM suite drop-down menus) and type your question, including preferred turn-around time. To view the evidence summaries for all geriatrics-related clinical questions previously submitted to the EBM Literature Request message basket, visit http://www.mc.vanderbilt.edu/km/geriatrics/index.html and select the paper icon under Details to view the evidence summary for each question.

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  1. Clinical Practice Guidelines

    USPSTF recommends against routine screening for colorectal cancer in patients older than 75 years

    Bottom Line: The United States Preventive Services Task Force (USPSTF) updated a previous statement regarding screening adults for colorectal cancer published in 2002. The 2008 statement recommends against routine screening adults ages 76 to 85 unless other considerations exist that support screening (C Recommendation). The Task Force recommends against screening adults 85 years and older based on moderate or high certainty that colorectal screening in this population has no net benefit or that the harms outweigh the benefits (D Recommendation). [full text »]
    Reference: U.S. Preventive Services Task Force. Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2008 October. [Accessed October 21, 2008]


    CDC releases new and expanded Hepatitis B testing recommendations

    Bottom Line: This comprehensive report updates previous CDC guidelines for HBsAg testing and expands recommendations for public health evaluation and managing chronically infected persons. New recommendations now emphasize routine testing for HBsAg in additional populations with HBsAg prevalence of >2%: persons born in geographic regions with HBsAg prevalence of >2%, men who have sex with men, and injection-drug users. The CDC also recommends that persons with liver disease of unknown etiology with persistently elevated ALT or AST levels should be tested for HBsAg. [full text »]
    Reference: Weinbaum CM, Williams I, Mast EE, Wang SA, Finelli L, Wasley A, Neitzel SM, Ward JW; Centers for Disease Control and Prevention (CDC). Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. MMWR Recomm Rep. 2008 Sep 19;57(RR-8):1-20. PMID: 18802412


    ACP recommends considering drug therapy for patients at risk for osteoporosis

    Bottom Line: Following an evidence-based systematic review of 76 randomized controlled trials published from 1966 through 2006, the American College of Physicians (ACP) developed the following guidelines regarding treatment of low bone density or osteoporosis... 1) The ACP strongly recommends pharmacologic treatment for patients with known osteoporosis and those who have experienced fragility fractures. 2) The ACP recommends that physicians consider pharmacologic therapy for men and women who are at risk for developing osteoporosis based on moderate evidence. 3) Based on that moderate evidence, the ACP strongly recommends that physicians judge the risks, benefits, and adverse effects of all drug therapy options for each individual patient. See Table 2 for a summary of evidence on each option and fracture risk. [full text »]
    Reference: Qaseem A, Snow V, Shekelle P, Hopkins R Jr, Forciea MA, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008 Sep 16;149(6):404-15. PMID: 18794560

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  1. Recently Published Research

    Multicenter RCT shows no significant difference in time to death with rosuvastatin vs placebo in CHF patients

    Bottom Line: This large, multicenter, randomized, double-blind, controlled trial from Italy assessed the efficacy and safety of 10 mg rosuvastatin (n=2285) versus placebo (n=2289) in adults with chronic heart failure of New York Heart Association class II–IV, irrespective of cause and left ventricular ejection fraction, over 3.9 years. Primary end points were time to death and time to death or admission to hospital for cardiovascular causes. Results showed no significant effect on primary endpoints in patients with CHF of any cause. [full text »]
    Reference: Gissi-Hf Investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Aug 29. [Epub ahead of print] PMID: 18757089


    RCT shows conflicting results for daily high-dose vitamin KI on bone loss and fractures in postmenopausal women with osteopenia

    Bottom Line: This randomized, placebo-controlled, double-blind trial from Canada examined the effect of daily high-dose (5 mg) vitamin K1 supplementation on reducing bone loss, bone turnover, and fractures in 440 postmenopausal women with osteopenia. Results showed similar decreases in lower back and hip bone density measurements in both groups after 2 and 4 years. However, fewer women in the vitamin K group had fractures and fewer had cancer over a 4-year period. The authors concluded that more large studies are needed and that given the apparent contradiction between the effects of vitamin K1 on bone density and on fractures, high-dose vitamin K1 supplementation should not be recommended for the prevention of osteoporosis until additional research is complete. [full text »]
    Reference: Cheung AM, Tile L, Lee Y, Tomlinson G, Hawker G, Scher J, Hu H, Vieth R, Thompson L, Jamal S, Josse R. Vitamin K Supplementation in Postmenopausal Women with Osteopenia (ECKO Trial): A Randomized Controlled Trial. PLoS Med. 2008 Oct 14;5(10):e196. [Epub ahead of print] PMID: 18922041


    Randomized trial shows no difference between episodic and continuous amiodarone therapy for major adverse events in ambulatory patients with recurrent persistent a-fib

    Bottom Line: This multicenter, randomized trial from the Netherlands compared the effects of episodic amiodarone treatment versus continuous amiodarone treatment after electrical cardioversion in 209 ambulatory patients with recurrent symptomatic persistent atrial fibrillation. The primary composite end point was any amiodarone- or underlying heart disease–related major adverse event, including heart failure, thromboembolic complications, bleeding, myocardial ischemia or infarction, and death. Results showed no significant difference in the incidence of the primary composite end point between groups (35% episodic vs 33% continuous). However, all-cause mortality and cardiovascular hospitalizations were higher among those receiving episodic treatment. [full text »]
    Reference: Ahmed S, Rienstra M, Crijns HJ, Links TP, Wiesfeld AC, Hillege HL, Bosker HA, Lok DJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT Investigators. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized trial. JAMA. 2008 Oct 15;300(15):1784-92. PMID: 18854540


    Multicenter RCT shows no significant change in cognition with vitamin B regimen versus placebo in AD patients

    Bottom Line: This multicenter, randomized, double-blind, placebo-controlled trial from the United States examined the efficacy and safety of B vitamin supplementation in the treatment of 409 patients with mild to moderate Alzheimer's disease (AD). Patients were randomized to a regimen of 5 mg/d folate, 25 mg/d of vitamin B6, and 1 mg/d of vitamin B12 supplements (n=240) or to placebo (n=169). Intention-to-treat analyses showed no significant difference between groups over 18 months for the primary outcome of change in the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-cog). Homocysteine levels were significantly reduced in the active treatment group (mean [SD], -2.42 [3.35] compared to the placebo group (-0.86 [2.59]; P < .001), although no significant effect was noted on primary and secondary outcomes. Depression was more commonly noted in the active treatment group. [full text »]
    Reference: Aisen PS, Schneider LS, Sano M, Diaz-Arrastia R, van Dyck CH, Weiner MF, Bottiglieri T, Jin S, Stokes KT, Thomas RG, Thal LJ; Alzheimer Disease Cooperative Study. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial. JAMA. 2008 Oct 15;300(15):1774-83. PMID: 18854539

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  1. FDA News & Safety Advisories

    FDA receives additional data from manufacturer of Spiriva HandiHaler showing no increased risk of stroke

    Bottom Line: October 07, 2008 — The FDA posted an early communication regarding its ongoing safety review of Spiriva HandiHaler® (tiotropium bromide) notifying the public and health care professionals about preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a 4-year randomized controlled trial assessing the safety and efficacy of Spiriva HandiHaler versus placebo in 6,000 patients with chronic obstructive pulmonary disease (COPD). Boehringer Ingelheim, the manufacturer of the Spiriva HandiHaler, reported preliminary results of UPLIFT to the FDA showing no increased risk of stroke with the drug compared to placebo. [full text »]
    Reference: Early Communication: Ongoing safety review of tiotropium (marketed as Spiriva HandiHaler). [Internet]. Medwatch 2008 safety alerts for drugs, biologics, medical devices, and dietary supplements. Rockville, (MD): U.S. Food & Drug Administration, Center for Drug Evaluation & Research. October 07, 2008. [Accessed October 22, 2008]


    FDA postmarketing adverse event review finds no significant incidence or risk of ALS with statin use

    Bottom Line: September 29, 2008 — Following a scientific review of the evidence from 41 randomized placebo-controlled trials, the FDA recommends no change in prescribing and use of statins, stating that its analysis provides new evidence that statin use does not increase the incidence of amyotrophic lateral sclerosis (ALS) despite receiving a higher than expected number of adverse event reports. [full text »]
    Reference: FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease". [Internet]. FDA News. Rockville, (MD): U.S. Food & Drug Administration, Center for Drug Evaluation & Research. September 30, 2008. [Accessed October 22, 2008]


    FDA continues ongoing safety review of risk of atrial fibrillation in patients taking bisphosphonates

    Bottom Line: November 12, 2008 — As a follow-up to the initial safety review announcement on reports of a rare occurrence of atrial fibrillation in persons taking bisphosphonates, the FDA announced that it is “exploring the feasibility of conducting additional epidemiologic studies to examine this issue” given disparate results in the available research literature and will continue to monitor post-market adverse event reports of atrial fibrillation in patients taking bisphosphonates as a part of its ongoing review. The FDA advised health care professionals not to alter their prescribing patterns for bisphosphonates and urged patients to continue taking bisphosphonate medication as prescribed at this time. [full text »]
    Reference: Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates. [Internet]. FDA News. Rockville, (MD): U.S. Food & Drug Administration, Center for Drug Evaluation & Research. November 12, 2008. [Accessed November 18, 2008]

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About Geriatrics Evidence Alert
The Geriatrics Evidence Alert is a monthly electronic newsletter developed by the Outpatient Clinical Informatics Consult Service (OCICS) at the Eskind Biomedical Library (EBL) to provide an update of selected evidence-based biomedical literature published in the past 30 to 60 days to physicians practicing at the Vanderbilt Internal Medicine department at Vanderbilt University Medical Center. The newsletter is also intended for Vanderbilt University partners and affiliates in the Nashville/Middle Tennessee area who provide clinical, research, and medical education services in the field of Geriatrics.

About OCICS
The OCICS provides current research evidence to support effective clinical decision-making and evidence-based practice by linking evidence expertise into clinical workflow using informatics tools.

How to Submit Clinical Questions to the OCICS for Research
For Vanderbilt physicians: To submit a complex clinical question to OCICS, select NewMsg from within your patient's chart in StarPanel and type your question, including your preferred turn-around time. To send the message, choose the blue link entitled EBM Literature Request located below the message box, or select the basket entitled EBM Literature Request located in each of the VIM suite drop-down menus. Complex questions submitted via NoMR messages for general knowledge building are also welcomed. To view literature summaries for all clinical questions previously submitted, visit the OCICS web site at http://www.mc.vanderbilt.edu/km/ocics/index.html.

Contact Us
For more information about OCICS or the Geriatrics Evidence Alert newsletter, contact Zachary Fox at zachary.e.fox@vanderbilt.edu.

DISCLAIMER: The Informatics Center Knowledge Management / Eskind Biomedical Library Geriatrics Evidence Alert is a current awareness tool prepared solely for informational purposes for the convenience of the clinician and other healthcare professionals. Librarians at the Eskind Biomedical Library attempt to provide accurate, inclusive, and informative reports. The information provided in the alert is not a substitute for clinical judgment. Biomedical practitioners should therefore take careful consideration of the original evidence presented in the full-text of the articles cited before taking action. This educational material is produced with the support of the Vanderbilt-Reynolds Geriatrics Education Center.



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