I'm All Shook Up … How to Stay Ahead of the Constantly Changing Medical Information Business Scott M. Strayer, MD, MPH Associate Professor Department of Family Medicine University of Virginia Health System Objectives 1. Apply a practical, evidence-based framework for evaluating medical information tools. 2. Understand how clinicians use point of care technology to “hunt” for evidence-based information that can be applied to clinical decision making on a daily basis. 3. Understand how clinicians use “foraging” tools to systematically sift through new medical information that is valid and relevant to clinical practice. 4. Evaluate “hunting” and “foraging” tools to determine the validity and relevance of their information sources. Scientific discoveries will require technological solutions that allow physicians to access the latest findings 24 hours a day, 7 days a week, online and on demand, as medical learning becomes a nonstop process Newt Gingrich, AAFP Assembly, Sep 28, 2006 Medical Information is Big Business Now! New EPS Research Forecasts The Scientific, Technical & Medical (STM) Information Market To Reach Nearly $11 Billion Dollars By 2008 ·Publicly-traded STM publishers grew 8.6% in their reported currencies in 2005; aggregate profit margins held steady at 25% ·Thomson posted the strongest increase in profits with a year-over-year gain of 20.5%, outperforming its peers and the market average of 17.7% ·Elsevier achieved the strongest organic growth: 5% and 6% in its Science & Technology and Health Sciences divisions, respectively ·The five largest players (Reed Elsevier, Thomson, Wolters Kluwer, Springer and Wiley) continued to acquire scale, and now account for over half (52.3%) of total market revenues ·Revenues from digital content distribution may be nearing a tipping point: 60% of STM First Wave of Acquisitions in Medical Information Business Wiley publishers now owns InfoRetriever and Info Poems, now “Essential Evidence” Ebsco publishers owns Dynamed Recent Changes Skyscape acquired by Physicians Interactive, Inc. (2009) Wolters Kluwers acquired UpToDate (2008) Large publishers and other businesses focused on profitability will continue to acquire evidence based sources How did most physicians find out about that new smoking cessation drug? Varenicline, an 4 2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Sustained-Release Bupropion and Placebo for Smoking Cessation A Randomized Controlled Trial David Gonzales, PhD; Stephen I. Rennard, MD; Mitchell Nides, PhD; Cheryl Oncken, MD; Salomon Azoulay, MD; Clare B. Billing, MS; Eric J. Watsky, MD; Jason Gong, MD; Kathryn E. Williams, PhD; Karen R. Reeves, MD; for the Varenicline Phase 3 Study Group JAMA. 2006;296:47-55. Context The 4 2 nicotinic acetylcholine receptors (nAChRs) are linked to the reinforcing effects of nicotine and maintaining smoking behavior. Varenicline, a novel 4 2 nAChR partial agonist, may be beneficial for smoking cessation. Objective To assess efficacy and safety of varenicline for smoking cessation compared with sustained-release bupropion (bupropion SR) and placebo. Design, Setting, and Participants Randomized, double-blind, parallel-group, placebo- and active-treatment– controlled, phase 3 clinical trial conducted at 19 US centers from June 19, 2003, to April 22, 2005. Participants were 1025 generally healthy smokers ( 10 cigarettes/d) with fewer than 3 months of smoking abstinence in the past year, 18 to 75 years old, recruited via advertising. Intervention Participants were randomly assigned in a 1:1:1 ratio to receive brief counseling and varenicline titrated to 1 mg twice per day (n = 352), bupropion SR titrated to 150 mg twice per day (n = 329), or placebo (n = 344) orally for 12 weeks, with 40 weeks of nondrug follow-up. Main Outcome Measures Primary outcome was the exhaled carbon monoxide–confirmed 4-week rate of continuous abstinence from smoking for weeks 9 through 12. A secondary outcome was the continuous abstinence rate for weeks 9 through 24 and weeks 9 through 52. Results For weeks 9 through 12, the 4-week continuous abstinence rates were 44.0% for varenicline vs 17.7% for placebo (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.70-5.50; P<.001) and vs 29.5% for bupropion SR (OR, 95%9CI, 1.40-2.68; Bupropion SR was also significantly more 21.9% efficacious placebo (OR, For 1.93; weeks through 52,P<.001). the continuous abstinence rates were forthan varenicline 2.00; 95% CI, 1.38-2.89; P<.001). For weeks 9 through 52, the continuous abstinence rates were 21.9% for vs 8.4% vs for8.4% placebo (OR,(OR, 3.09; 95% 1.95-4.91; P<.001) vsfor16.1% for SR (OR, 1.46; varenicline for placebo 3.09; 95% CI, CI, 1.95-4.91; P<.001) and vsand 16.1% bupropion 95% CI, 0.99-2.17; P = .057). Varenicline reduced craving P and=withdrawal bupropion SR (OR, 1.46; 95% CI, 0.99-2.17; .057). and, for those who smoked while receiving study drug, smoking satisfaction. No sex differences in efficacy for varenicline were observed. Varenicline was safe and generally well tolerated, with study drug discontinuation rates similar to those for placebo. The most common adverse events for participants receiving active-drug treatment were nausea (98 participants receiving varenicline [28.1%]) and insomnia (72 receiving bupropion SR [21.9%]). Conclusion Varenicline was significantly more efficacious than placebo for smoking cessation at all time points and significantly more efficacious than bupropion SR at the end of 12 weeks of drug treatment and at 24 weeks. For weeks 9 through 52, the continuous abstinence rates were 21.9% for varenicline vs 8.4% for placebo (OR, 3.09; 95% CI, 1.95-4.91; P<.001) and vs 16.1% for bupropion SR (OR, 1.46; 95% CI, 0.99-2.17; P = .057). 95% C.I. Since the 95% CI crosses 1.0, the difference is not significant 0.99 Difference could be this minimal (1% decrease) 1.0 1.46 2.17 Difference could be this high (117% increase) How Well Do We Distribute New Information? Left to our own devices 1987: Of 28 Landmark trials, only 2 had an immediate (1-2 year) effect on clinical practice Fineberg HV. Clinical evaluation: how does it influence medical practice? Bull Cancer 1987;74:333-46. 1992: Thrombolytic therapy for acute MI: 13 years after proof of benefit before review articles suggest it for routine use Antman EM, et al. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. JAMA 1992;268:240-8. How Well Do We Distribute New Information? 1996: Little effect of publication of the ISIS-2 (Aspirin works post-MI) and diltiazem postinfarction trial (diltiazem doesn’t work).---ASA and Diltiazem use---no change after trial Col NF, et al. The impact of clinical trials on the use of medications for acute myocardial infarction. Arch Int Med 1996; 156: 54 - 60. Majumdar 2003: HOPE study – in ramipril prescribing by 5% per month without advertising, 12% per month with advertising over the next 2 years Majumdar SR, et al. Synergy between publication and promotion: Comparing adoption of new evidence in Canada and the United States. Am J Med 2003;115:467-72. How Well Do We Distribute New Information? Bottom Line: Change occurs quickly When supported by lots of publicity or pharmaceutical company marketing (like any consumer product) Change is much slower When left up to publications or word of mouth for dissemination of information Two Tools Needed to Master Information- BMJ 1999 A method of being alerted to new information (a “foraging” or “push” tool) A tool for finding the information again when you need it. (a “hunting” or “pull” tool) Without both: You don’t know that new info. is available You can’t find it when you do Clinical example- Anticholinergics for COPD Shaughnessy AF, Slawson DC. Are we providing doctors with the training and tools for lifelong learning? British Medical Journal 1999 (13 Nov): www.bmj.com. (http://bmj.com/cgi/reprint/319/7220/1280.pdf) Information Mastery in a Nutshell Clinically useful information can be defined by: Usefulness = Relevance x Validity Work Slawson DC, Shaughnessy AF, Bennett JH. Becoming a Medical Information Master:Feeling Good About Not Knowing Everything. The Journal of Family Practice 1994;38:505-13. Effect on Patient-Oriented Outcomes Symptoms Functioning Quality of Life Lifespan Valid PatientOriented Evidence Effect on Disease Markers Diabetes Arthritis Peptic Ulcer Effect on Risk Factors for Disease Improvement in markers (blood pressure, cholesterol) Uncontrolled Observations & Conjecture Physiologic Research Preliminary Clinical Research Case reports Observational studies Validity of Evidence Highly Controlled Research Randomized Controlled Trials Systematic Reviews Strayer’s Corollary: Information Mastery and Computers Not always assessed by software Usefulness = Relevance x Validity Work Can be reduced by computers Slawson DC, Shaughnessy AF, Bennett JH. Becoming a Medical Information Master:Feeling Good About Not Knowing Everything. The Journal of Family Practice 1994;38:505-13. Clinicians demand “just-in-time” resources 48 randomly selected generalist physicians in ambulatory care Asked 1062 questions but only answered 585 (55%) Obstacles: Doubt that answer exists (11%) Selected source doesn’t have answer (26%) Requested comprehensive sources that answer questions likely to occur in clinical practice with emphasis on treatment and bottom-line advice Help locating information quickly with lists, bolded sub-headings, algorithms….avoid lengthy text Ely et al J Am Med Inform Assoc. 2005 Mar-Apr;12(2):217-24. Quality Hunting and Foraging Systems---A New Definition 1. How is the information filtered? Patient- vs disease- oriented? Specialty-specific? Comprehensive? Which journals? Does it matter (change my practice?) or is it simply news? 2. Is the information valid? must have levels of evidence labels Beware “Trojan Horse”! Quality Hunting and Foraging Foraging Systems 3. How well is information summarized? 2000 - 3000 words accurately in 200 words 4. Is the information placed into context? Much more than abstracts “Translational Validity” Hunting Tools Hunting First Consult—www.firstconsult.com Essential Evidence Up To Date---www.uptodateonline.com DynaMed---www.dynamicmedical.com/ Medscape---www.medscape.com Database of Abstracts of Reviews of Effectiveness DARE---http://agatha.york.ac.uk/darehp.htm Translating Research Into Practice (TRIP)--www.tripdatabase.com Foraging Tools Systematically identified tools between MayAugust 2007 Searched Internet for all medical content sites (e.g. Medscape, WebMD, etc.) Searched well-known evidence-based databases (e.g. Cochrane, TRIP, DARE) Monitored List-serves for Health IT and PDA tools (e.g. Palm-Med, Wireless Medical Applications, STFM EBM) Consulted with experts and practicing physicians Sent invitations to list-serves for suggestions tool Abbrev. URL American College of Physicians Journal Club AC www.acpjc.org American Family Physician Tips AF www.aafp.org BMJ Clinical Evidence CE http://clinicalevidence.bmj.com/ceweb/index.jsp Cochrane for Clinicians CC http://www.aafp.org/afp/20070501/cochrane.html Doctor’s Guide DG www.docguide.com Dynamed Weekly Update DM http://www.ebsconewsletter.com/dmweeklyupdate/index000 242960.cfm?x=b11,0,w Epocrates DocAlerts EP www.epocrates.com Essential Evidence Plus (formerly InfoPoems) EE http://infopoems.com FPIN Clinical Inquiries FP http://www.aafp.org/afp/20070101/fpin.html Global Family Doctor Daily Alerts GF www.globalfamilydoctor.com Journal Abstracts Delivered Electronically (JADE) JD www.biodigital.org/jade Journal Watch JW www.jwatch.org MD Linx Network LX www.mdlinx.com Medscape Best Evidence (also BMJ Updates and McMaster Plus) ME www.medscape.com PeerView Institute PV www.peerview-institute.org Physician’s First Watch PW http://firstwatch.jwatch.org/misc/about.dtl?q=etoc Skyscape ARTbeat SA www.skyscape.com/Estore/ProductDetail.aspx?ProductID= 924 Treatment Guidelines TG www.medicalletter.org Hunting and Foraging System Risks “Spyware”: May be tracking your usage “Trojan Horse”: who’s paying when it’s free? Abstracts only: Journal Watch, Journal Rack, Tips from other Journals, Clinical Updates, etc. No relevance/ validity filter You can have information “free” and you can have it “uncensored”, but you can’t have it both ways. No Free Lunch! Not All Information Tools are Created Equal! Quality of Drug Foraging and Hunting Tools Strayer, SM, Slawson, DC, Shaugnessy, AM, Disseminating Drug Prescribing Information: The COX-2 Inhibitor Withdrawals. JAMIA 2006. 13:396-398. A Few Foraging Tools… Beware of the Trojan Horse Will Skyscape Become a new Trojan Horse Information Source? A Few Hunting Tools… Rating Hunting and Foraging Tools Rating Hunting and Foraging Tools Hunting Tool Evaluation Worksheet Foraging Tool Evaluation Worksheet BMJ Updates Hunting and Foraging Tools Foraging InfoPoems---www.infopoems.com Peer View Institute--www.peerview-institute.org/ Journal Alerts--www.globalfamilydoctor.com/daily alerts/main.htm Medscape Best Evidence (http://hiru.mcmaster.ca/MORE/Ho wRatingsAreUsed.htm) MDLinx BMJ Updates (http://bmjupdates.mcmaster.ca) First Watch (www.jwatch.org) Cochrane PEARLS Hunting First Consult— www.firstconsult.com InfoPoems Up To Date--www.uptodateonline.com DynaMed--www.dynamicmedical.com/ Medscape--www.medscape.com Database of Abstracts of Reviews of Effectiveness DARE--http://agatha.york.ac.uk/dareh p.htm Translating Research Into Practice (TRIP)--www.tripdatabase.com Foraging Tools Results Only seven tools had specific criteria for both relevance and validity American College of Physicians Journal Club BMJ Clinical Evidence Cochrane for Clinicians DynaMed Essential Evidence (formerly InfoRetriever) FPIN Clinical Inquiries Treatment Guidelines (Medical Letter) Summarize Evidence-based clinical decision making requires a coordinated “hunting” and “foraging” tool. Use the principles of Information Mastery to evaluate your information tools. Not all information tools are created alike--evaluate using worksheets. Contact Information E-mail: sstrayer@virginia.edu Information Mastery Course: http://www.healthsystem.virginia.edu/inter net/familymed/information_mastery/inform ation_mastery_course.cfm Center for Information Mastery: http://www.healthsystem.virginia.edu/inter net/familymed/information_mastery/info_m astery.cfm