Evidence Based Medicine

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‎ay‏ طبا للم 

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EVIDENCE BASED MEDICINE Clista Clanton, MSLS, AHIP June 28 & 29, 2012 

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Today’s topics * What is EBM? * Why is it important? = Complementary/Alternative medicine = Developing the “well built” clinical question * Searching for evidence " Evaluating the evidence 

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What is evidence based medicine (EBM) ? = “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” The integration of individual clinical expertise with the best ۱ Curent accu ate ige ns ‎Ns PLM PL WUC Ree <clcere a Reel elt‏ ری 3 ,وأممام0 مأ ‎esis‏ كعؤوو الك ال ‎ee eee eh ee a ee Rae ‏ا‎ 

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Best available research evidence Environment & organizational context Client/Poputation characteristics, state, needs, values, & preferences Resources. including practitioner expertise Adapted from: Sackett D.L., Rosenberg M.C., Gray J.A., Haynes R.B., Richardson W.S. (19¢ 2 ea eur as cane 1 es ee eee 

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Why is EBM important? " New types of evidence are being generated which can create changes in the way patients are treated » How much is actually being applied to patient care? Although evidence is needed on a daily basis, usually physicians don’t get it. lack of time out-of-date textbooks, and the disorganization of the up-to-date journals® fen lee a une OO a ene en as oe ee) Bernier are 

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Why is EBM important? " Up-to-date knowledge and Clinical _ performance can deteriorate with time There is a statistically and clinically significant negative correlation between a physician’s knowledge of up to date care and the years that have elapsed since graduation from medical school. Traditional continuing medical education programs have not been shown to improve clinical performance Systematic reviews of the relevant randomized trials have shown that traditional, instructional CME fails to modify clinical performance and is ineffective in improving the healtt outcomes of patients. Ramsey PG, Carline JD, Inui TS et al: Changes over time in the knowledge base of practicing internists. JAMA 1991:266:1103-7: عها اه عبر ناه ا 00 

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Why is EBM important? 1 ‏ا‎ SEL TE Observed ites نيليا زر روز و ۱ ۱ ۱ ۱ فورت ۱9 رت 1 و ععلك أه مون 0.5 #ماذاء معقاععمدمنا عا وننوء5 Garlic, mustard and ۱۵۲5۵۲2۵60 Genta aera ۱ سس * Knowledge translation - increasing the uptake of the best available evidence into practice - has always been a challenge Scurvy: use of citrus ee ‏کت ات روز‎ and cure scurvy in 1754, but it was almost 50 ۷6۵۲5 2۴۲6۲ ۲۴6 0۵12 ۷۵5 published before lemon juice was added to ‏کمنداک طکناز:8‎ ۱ ۸66۵5560 6 8 

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Puerperal fever Yearly mortality rates First clinic * Second clinic Mee eco ee Ae eRe ‏اه‎ ‎Me kee ROMAN. a a Ae R@L ed ee! 

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Why is EBM important? onic Rem He Ey ‏ا‎ ese mCccmcoital Mate ech mest eer ae Meh Ruri noe Cee) OSL ‏ار ات‎ ‏یر‎ scree SMU MM rele emit gr Bs Fete hed a elcell eae acto Tilsen ‏ل‎ ek see Table 2. Mortality rates and characteristic of obstetrics clinics in Vienna 1784-1859 Perio | Characteristics of period ۱ 7 Teal d Cra oa ete cee 0 ‏عطامعه‎ | ۵0۷۵/6 1784- | No routine post-mortems ۸۳ 7 12.5 1822 ‏ا ا‎ 65,35 3,745 7 1838 1839- | Clinic arrangements changed cease ee ue wa ‏للك‎ 1,989 902 Second clinic: midwives 17,791 co 33.8 Perea ence cnnm ic) 1859 | ‏عأماك عمماع‎ 47,938 1,712 357 566000 ‏عون‎ 40,770 148 30.6 

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Puerperal fever 

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The Translational Continuum بابل د ب سس _ Dissemination Adoption aor sey, ats ovens rat, Late Translation > of ‘advance by 02 Provides, + Reguitery 0 + Toconmunty ah ones > ‏سوه‎ Seema + Prshadion & ‏مس‎ ‏مذه سس‎ 1 و مس اد + Pavone ‏ایا‎ ‎۳ ‏موی ورن‎ + Heath services ‏تسس‎ اور اه مهم س Early Translation + Parmerstis ane ‏سس‎ | (cadens, ها ‎inary‏ + te verti ‏ات‎ امد Pan's Basic Science Discovery Promising oka o gene get + Candia ‏متم مر‎ blame Baste ‏وم‎ ‏مه‎ بش۳ و ی ‘esearch Concer Co Delvermeon th Pose 

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Complementary/Alternative 0 ۹۹ and alternative medicine is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. While some scientific evidence exists regarding some CAM therapies, for most there are key questions that are yet to be answered through well-designed scientific studies--such as: _ Are these therapies safe? _ Do these therapies work for the diseases or medical conditions for which they are used? jenter for Complementary and Alternative Medicine. Understanding complementary and alternative medicine. A ۱ ‏نال‎ 

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Are Complimentary and Alternative Medicine Interchangeable Terms? = Complementary medicine is used together with conventional medicine. Example: Using aromatherapy to help lessen a patient's discomfort following surgery. Alternative medicine is used in place of conventional medicine. Example: When Suzanne Somers rejected chemotherapy in favor of a drug called Iscador (uses extracts of Mistletoe) to treat her breast cancer. National Center for Complementary and Alternative Medicine. Understanding complementary and Blatt nearer se 17 

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Family: Woman Died After Choosing Herbal Medicine Over Cancer Surgery ]0 أمععمعم 60 غقطغ عه مرأؤوع 5عغ1أل ند ‎cancer patients try unconventional‏ ‎remedies and about 40 percent take‏ ‎vitamin or dietary supplements‏ None has turned out to be a cure, although some show promise for easing symptoms. Touch therapies, mind-body approaches and acupuncture may reduce stress and relieve pain, nausea, dry mouth and possibly hot flashes, and are recommended by many top cancer experts. A recent study found that ginger capsules eased nausea if started days before chemotherapy. One quarter of supplements tested by an independent company over the last decade have had some sort of problem. Some contained contaminants. Others had contents that did not match label claims. Some had ingredients that exceeded safe limits. Some contained real drugs masquerading as natural supplements. 

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$2.5 billion spent, no alternative cures found Big, government-funded studies show most work no better than ‏راتت‎ The Associated Press updated 11:15 a.m. CT, Wed., June 10, 2009 BETHESDA, Md. - Ten years ago the government set out to test herbal and other alternative health remedies to find the ones that work. After spending $2.5 billion, the disappointing answer seems to be that almost none of them do. Echinacea for colds. Ginkgo biloba for memory. Glucosamine and chondroitin for arthritis. Black cohosh for menopausal hot flashes. Saw palmetto for prostate problems. Shark cartilage for cancer. All proved no better than dummy pills in big studies funded by the National Center for Complementary and Alternative Medicine. The lone exception: ginger capsules may help chemotherapy nausea. As for therapies, acupuncture has been shown to help certain conditions, and yoga, massage, meditation and other relaxation methods may relieve symptoms like pain, anxiety and fatigue. 

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Major Types of Complementary and Alternative Medicine Alternative medicine systems: Built upon complete systems of theory and practice. Examples: homeopathic medicine, naturopathic medicine, traditional Chinese medicine, Ayurveda. Mind-body interventions: Uses a variety of techniques designed to enhance the mind's capacity to affect bodily function and symptoms. Some techniques that were considered CAM in the past have become mainstream (patient support groups and cognitive-behavioral therapy). Other mind-body techniques are still considered CAM, including meditation, prayer, mental healing, and therapies that use creative outlets such as art, music, or ‎Gee eR Ceca cI‏ ی ‎ti) httoyinccam nih gow/health/.‏ ‎5 Za Ves re ‎prey 

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Major Types of Complementary and Alternative Medicine cont. * Biologically Based Therapies: Use substances found in nature (herbs, foods, and vitamins). Example: shark cartilage to treat cancer. ~ Examples of dietary supplements that have been incorporated into mainstream medicine: = Folic acid to prevent birth defects © Regimen of vitamins and zinc to slow the progression age-related macular degeneration (AMD). Lee eR ede Meri st eA ‏ی و‎ Puerta rea Wen ers a 

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Major Types of Complementary and Alternative Medicine cont. * Manipulative or Body-Based Methods: Based on manipulation and/or movement of one or more parts of the body. Examples: chiropractic or osteopathic manipulation, massage. Energy Therapies: Involve the use of energy fields. - Biofield therapies: intended to affect energy fields that purportedly surround and penetrate the human body (the existence of such fields has not yet been scientifically proven). Examples: qi gong, Reiki, Therapeutic Touch. _ Bioelectromagnetic-based therapies: unconventional use of electromagnetic fields, such as pulsed fields, magnetic fields, or alternating-current or direct-current fields. National Center for Complementary and Alternative Medicine. Understanding complementary and 0 raat ragtime Ceti 0 Sennen nee 

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NCCAM National Center for Complementary and Alternative Medicine Part of NIH, established in 1998 Dedicated to exploring complementary and alternative healing practices in the context of rigorous science, training complementary and alternative medicine (CAM) researchers, and disseminating authoritative information to the public and professionals. NCCAM Web site (nccam.nih.gov): publications, information for researchers, frequently asked questions, and links to other CAM-related resources. 

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N National Center for Complementary and Alternative Medicine At the National Institutes of Health NIH..Tuming Discovery Into Health stay Connected? BOG Via emal, RSS, Twitter, or Facebonie Teoma Related to Complementary and sternative Medicine Dietary Supplements ‘Adverse Event Reporting Statistics on Complementary and Alternate Medione use TIME TO TALK Resources for Health Care Providers ‘The evidence-basea resources on tis page, suct as research results and dintal practice ‘uideines, wil help prepare you to discuss CAM approaches wth your patents. [Hi take a video tour ofthis resource > Evidence-Based Medicine study Determines Optimal Dose Lterture Reviews from ‘of Massage for Osteoarthritis of Pubmed® the Knee Pain Research Esloence Reports trom ARE Read more > Ccoctvane Reviews cr ‏جر‎ - en) ‏اه‎ Practice Guidelines Fulltext quisaines for encaiogs, rheumatologists, general medicine Healt Tsetse AZ pracenaners, and more. Evidence, from acupuncture to zinc NCCAM Clinical Digest Newsletter Honthly e-newsetter that summaries the sta of the soence on complementary heath pracuces and a neat conation. For Your Patients > Printable factsheets and inks to more resources. Continuing Education FREE CME/CEU vieeo tures 

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Found 361 studies with search of: Closed Studies | Exclude Unknown | NCCAM Study Evaluation of Echinacea for the Common Cold ‘conelion Gammon Cals Intervention” Drug: Echinacea (igong Therapy For Heart Device Pationts Condlitons. Depressive Disc; Cardiac Diseases Inferveniions. Behavioral Aerobic and Resistance Exercises, Behavioral Qigong Completed PUFA Augmentation in Treatment of Major Depression ‘Concition: Major Doprossion| Ioferventions Drug Polyunsaturated Fatty Acids (PUFA), Drug’ Cialoptam Interactions Between Cranberry Julee and Antibiotics Uses to Treat Urinary Tract infections ‘Conetion. Unnary Trac infections Interventions Drug. Cranbery ice, Drug. Amoxtciin Phytocetrogens and Memory Decline in Menopause Condtions. Memory Loss, Postmenopause Intervention” Drag: solavones Completed ‘Condition. Fibromyalgia Intervention, Drug. Active liquid remedy Using MRI Scans to Evaluate Spinal Manipulation ‘Gonation: Lower Back Pain Inlervetion Procedure. Lumbar side posture spinal adjusting Spirituality and Wil to Live in Pationte With HIVIAIDS ‘Coneiion HIV infections Intervention Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERE CHE) Tal ‘Condon. Chronic Hear Faire Intervention” Drug: Crataegus Special Extract WS 1442 

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{GT Search of (NCCAM) [SPONSOR] (mist | ClinicalTrials.gov Found 2 studies with search of: (NCCAM) [SPONSOR] (mistletoe) [TREATMENT] Hide studies thot are not seeking new volun Rank statue 1 Active, not recruiting tletoe in Treating Patients With Advanced Soli Cancer Celeectal Cancer. Lung Cancer Inveentons Supeement misteos exact, Diug. gemelabine ‏امار‎ ‎Completed ‎ing Canes Drag lecar | Oras: ist sing tis page search wil be p gain onthe ‏ایو‎ RSS Feds for studies found by your search that were: nthe Inst 14 days, Last updated (includes received) in the last 20 days 

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CAM Use by U.S. Adults and Child 38.3% Children (2007) 

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39.6% © 40.1% مبسييسي يي ‎Sr‏ ‏7084 604 5059 40-49 30:39 18-29 Age 

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‘American inion! Asian Black Hispanic ‘Alaska Native ۳ PM, Bloor 8, Nahin RD att Report #712. Complementary and emai Mains Use Among Adit and Cider: 

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10 Most Common CAM Therapies Among Adults - 2007 لم |9 Therapies with significant increases between 2002 and 2007 are 2002 07 Deep breathing 11.6% 127% Meditation 76% 98% Massage 50% 39 Yoga 51 6.1% # ss & & et, ee & et fe * ‏ا‎ é 

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10 Most Common Natural Products Among Adults* - 2007 fo) ana 113% 1126 

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Diseases/Conditions for Which CAM lls Most Frequently Used Among Adults - 2007 20 111% 

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Most Common Natural Products Among Children* - 2007 Echinacea ‏لا‎ Combination Heeb Pils ral prods inthe ast 30 das, Seance: Barnes PA 8 ‏هکم‎ Report ۱2 6۵۳ ‏ع9 مجعالة جه‎ 0/6 Sines 200) Decent 

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What is EBM? " “Evidenced-based medicine is the concept of formalizing the scientific approach to the practice of medicine for 1060۱60 of “evidence” to support our clinical decisions. It requires an understanding of critical appraisal and the basic epidemiologic principles of study design, point estimates, relative risk, ‏تن‎ ratios, confidence intervals, bias, and confounding. By using this information, clinicians can categorize evidence, assess causality, تفه ‎tel Cicer‏ وا رات تفت بات ی 

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Developing the clinical question = Step 1: Formulate the clinical issue into a searchable, answerable question. * Step 2: Distinguish what type of question you may have. Backgroun 0 Foreground Experience with Condition 

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Background questions ™Background questions ask for general information about a condition or thing. " ‏م‎ question root (who, what, when, etc) combined with a verb. What microbial organisms can cause community-acquired pneumonia? Background questions are typically answered by textbooks. 

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Foreground questions = Foreground questions ask for specific knowledge about a specific patient with a specific condition. Is St. John’s Wort effective in relieving the symptoms of post- partum depression? Foreground questions are typically answered by databases that access the research literature 

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Developing the question = Foreground questions usually have four components. P = Patient population | = Intervention C = Comparison O = Outcome 

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تور با 30 04 رت ار ره )۱ The patient population or disease of interest -age - gender - ethnicity - with certain disorder (e.g., hepatitis) The intervention or range of interventions of interest - Exposure to disease - Prognostic factor A - Risk behavior (e.g., smoking) What you want to compare the intervention against - No disease - Placebo or no intervention/therapy - Prognostic factor B - Absence of risk factor (e.g., non-smoking) Outcome of interest - Risk of disease - Accuracy of diagnosis - Rate of occurrence of adverse outcome { death) Patient population/disease Intervention Comparison 

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affect or [Comparis |[Outco on, if any] |me] lead toa 095 ۱ anal [Patient/ Problem] ,۵ 6۱۲۵۱۱6 ]۷۱ کاصهنهم ۱۱ lessening of pain? و تیا ریات ایا ریا و نیت عت :۰ یا posterior vaginal wall prolapse, help? In patients with moderate depression, Veh traditional SSRIs ‏ل ات۱۱۱‎ M Lm hile adverse effects? 

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Types of Questions ™ Diagnosis: How to select a diagnostic test or how to interpret the results of a particular test. ™ Prognosis: What is the patient's likely course of disease, or how to screen for or reduCe risk. ™ Therapy: Which treatment is the most effective, or Shere an effective treatment for a particular condition. ™ Harm or Etiology: Are there harmful effects of a particular treatment, or how these harmful effects can be avoided. ™ Prevention: How can the patient's risk factors be adjusted to help reduce the risk of disease? ™ Cost: Looks at cost effectiveness, cost/benefit 2۱۷516۰ 

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تست انلا ۴ 660۲ 6 وا ۷۷۵۲ , ‎In‏ compared with 9 Etiology Are ‏عناقط وحانها‎ at risk for/of ‏ل‎ ‎with/without 1 Diagnosis or Diagnostic Test Are (Is) more accurate in diagnosing ‏انها 30م ممع‎ 2 ممعم ممم ‎does the use of reduce the‏ ممع ‎ave mee aol compared with 9‏ Prognosis Does influence in patients who LEW) 

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Medical literature " Secondary - reviews of original research Meta-analysis Systematic reviews Practice guidelines Rtn ۱9 ‏در ورام مت‎ Consensus reports Editorial, commentary = Primary - original research Experimental (an 0 Ne oe uC ute) | rem ۳ Observational (no 0 manipulated) ‏ل"‎ ‎۱۳۰۰ ‏سرت‎ ‎۰ 

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Case series/case reports " Reports on treatment, etc. of individual patients ieee eer De Um leet mda) automatic word processing and self-hypnosis: a case report. ‘Am J Clin Hypn. 2005 Oct-2006 Jan;48(2-3):191-8. Binge eating frequently is related to emotional stress and mood problems. In this report, we describe a 16-year-old boy who utilized automatic word processing (AWP) and self-hypnosis techniques in treatment of his binge eating, and associated anxiety, insomnia, migraine headaches, nausea, and stomachaches. He was able to reduce his anxiety by gaining an understanding that it originated as a result of fear of failure. He developed a new cognitive strategy through AWP, after which his binge eating resolved and his other symptoms improved with the aid of self-hypnosis. Thus, AWP may have helped achieve resolution of his binge eating by uncovering the underlvina psvcholoaica! causes of his svmptoms. and self- 

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Case Control Studies * Studies in which patients who already have a specific condition are compared with people who do not * Rely on medical records and patient recall for data collection 

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Hepatitis C; a retrospective study, literature review, and naturopathic protocol Mo, Alternative Medicine Review. 5(4):355-71, 2000 Aug. The standard medical treatment of hepatitis C infection is only associated with sustained efficacy in a minority of patients. ‏تفا روت نیت ت۱۱‎ importance. Several natural products and their derivatives have demonstrated benefit in the treatment of hepatitis C and other chronic liver conditions. Other herbal and nutritional supplements have mechanisms of action that make them likely to be of benefit. This article presents comprehensive protocol, including diet, lifestyle, and therapeutic interventions. The ‏در را‎ a retrospective review of 41 consecutive 4 Of the 14 patients with baseline and follow- up data who had not undergone interferon therapy, seven had a greater than 25-percent reduction in serum alanine aminotransferase (ALT) levels after at least one month on the protocol. For all patients reviewed, the average reduction in ALT was 35 U/L (p=0.026). These data appear to suggest that a conservative approach using diet and lifestyle modification, 

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Cohort studies " From a large population, follows patients who have a specific condition or receive a particular treatment over time and compared with another group that has not been affected by the condition or treatment studies 

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۱ ۱۱۱۹۱۵۱ ۱۱۱ BY 5+ Yoga practice is associated with attenuated weight gain in ‏ات وت یت ات یی تیا‎ Jul-Aug;11(4):28-33. BACKGROUND: Yoga is promoted or weight maintenance, but there is little evidence of its efficacy. OBJECTIVE: To examine whether yoga ‎(a‏ تا ‎Lan‏ ارات طاغأينا لعغواء3550 ذأ ععأغع هم ,6315لا 57 0غ 53 3960 ‎PARTICIPANTS: Participants included == ,‏ ‎recruited to the Vitamin and Lifestyle (VITAL) cohort study ==‏ ‎MEASUREMENTS: Physical activity (including yoga) during the‏ ,._.- ‎past 10 years, diet, height, and weight at recruitment and at ages 30 and‏ ‎All measures were based on self-reporting, and past weight was‏ .45 ‎retrospectively ascertained. METHODS: Multiple regression analyses were‏ ‎used to examined covariate-adjusted associations between yoga practice‏ ‎and weight change from age 45 to recruitment, and polychotomous‏ ‎logistic regression was used to examine associations of yoga practice‏ ‎with the relative odds of weight maintenance (within 5%) and weight loss‏ ‎compared to weight gain. RESULTS: Yoga practice for four or‏ )5% >( ‎more years was associated with a 3.1-Ib lower weight gain among normal‏ ‎weight (BMI < 25) participants [9.5 Ibs versus 12.6 Ibs] and an 18.5-Ib‏ ‎lower weight gain among overweight participants [-5.0 Ibs versus 13.5‏ ‎Ibs] (both P for trend <.001). Among overweight individuals, 4+ years of‏ ‎yoga practice was associated with a relative odds of 1.85 (95%‏ ‎confidence interval [Cl] 0.63-5.42) for weight maintenance (within 5%)‏ ‎and 3.88 (95% CI 1.30-9 88) for weight loss (> 5%) compared to weight‏ ‎ ‎ 

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Randomized controlled trials " Study effect of therapy on real patients * Include methodologies that reduce the potential for bias = Intervention group vs control group = Patients assigned in randomized fashion = Blinded or non-blinded studies 

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سس ‎Kumar Sk, Sandesh kK,‏ فده سس را انا اعها ‎HerikunianR,‏ ‏وت ور یت ‎err iCute‏ ‎sedative medication during colonoscopy: a randomized,‏ ‎controlled trial. Indian J Gastroenterol. 2006 Jan-Feb;25(1):3-‏ .5 ‎BACKGROUND: Music played during endoscopic procedures‏ ‎may alleviate anxiety and improve patient acceptance of the‏ ‎prospective randomized, controlled trial ()-—‏ \./ سور ‎undertaken to determine whether music decreases the‏ ‎requirement for midazolam during colonoscopy and makes‏ ‎the procedure more comfortable and acceptable. METHODS:‏ ‎Patients undergoing elective colonoscopy between October‏ ضع15! غم معطئاء م6 لم2 أمعهلمصقم فنع يناد 2004 ‎and February‏ 2003 ‎to music (Group 1; n=40) or listen to music of their choice‏ تسسس وس ‎(Group 2) nse) during the procedures .\) f+‏ طعقء وم 2 5ه 5غمنوتات دأ لمفتصعل نه نمهامع ه210 كنممع لد اما ‎The dose of midazolam, duration of procedure, recovery time,‏ ‎pain and discomfort scores and willingness to undergo a‏ ‎repeat procedure using the same sedation protocol were‏ ‎compared. RESULTS: Patients in Group 2 received‏ ‎significantly less midazolam thanthoseinGroupl ==‏ ‎The pain score was si rin the two groups, whereas‏ 

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Systematic review Extensive literature search is conducted in systematic fashion Only uses studies with sound methodology Studies are collected, reviewed, assessed and the results summarized according to predetermined criteria of the review question 

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ا 010 Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing | Database of Systematic Reviews 2004, Issue 2. ree ee een ate aN an ame ase NUR nC Nae several decades for the prevention and treatment of urinary tract infections (UTIs). The aim of this PRS eon ‏ل‎ at CoM tao / ‏وا كاعنلممم لمع طمدى ععطاه لمة ععلناز رمع طمدى أن ددع مع عع لاع عط دمعدكة 10 ندع نالى ع زط9‎ 1 rt as ees cr ale see re reser Rut cae eee en een a eae ay English language terms; companies involved with the promotion and distribution of cranberry rite Reel Toc Me ie a Rae te tel eee etter TR tc gaat 562۲6۳6۵ ۱0 ۴۵۵۳۱۵ 3 0 cee ORC U is Reel Renae i Bees ‏ی‎ er ‏ل‎ ae Uae sae ete Ee Dee at ee ene te a ee eee ster eet tS Macuser caste ee ome eel em a et cestode pcg tad cata ‏ت یت ی ی‎ eee Rae ste sae Me ae ar ceva trie ice came) ‏وطآقنا 560و 5و2‎ ۱۱6 ۵0۱۵0۵ ۵۵۰ ee eer a eee a NC egret) ‏ل ا‎ tees ela Cm Yee Re eae MMR rato cette cet oem ete Reo two trials (one study evaluated both juice and tablets). In two good quality RCTs, cranberry products significantly reduced the incidence of UTIs at twelve months (RR 0.61 95% CI:0.40 to 0.91) Ree Man tac een a ee RCL eee Ree ‏ل‎ t ae ‏عبرهو ععطاه عط ,لاحم‎ ee Rese ues eee Met Tae oa ‏مه كقن عمعط؟‎ etre ic ie ate a ae ‏یی ات‎ ge (RR 1.11 95% CI:0.49 to 2.50). Five trials were not included in the meta-analyses due to ‏ای‎ alg ۱ ee rare ie cee ‏ا‎ acorn ia et Teer Rm ‏ی‎ es Authors’ conclusions: There is some evidence from two good quality RCTs that cranberry juice 

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Meta-analysis " Examines a group of valid studies on 2 " Combines results using accepted statistical methodology to reach a consensus on the overall results 

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Linde K, Berner M, Egger M, Mulrow C. 5 (۵۱8۳5 ۷۵۳۲ ۲۵۲ 060۲655100: ۵۲۵-۵۵۵۱۷5۱5 ۴ randomised controlled trials. Br J Psychiatry. 2005 Feb;186:99-107. BACKGROUND: Extracts of Hypericum perforatum (St John's wort) are widely used to treat depression. Evidence for its efficacy has been criticised on methodological grounds. AIMS: To update evidence from randomised trials regarding the iced Rem abe mangle Wie fois: We sserrricc| a systematic review and meta-analysis of 37 double-blind randomised controlled trials ‏ممع‎ ‎clinical effects of Hypericum monopreparation with either placebo or a standard antidepressant in adults with depressive disorders. RESULTS: Larger placebo-controlled trials restricted to patients with major depression showed only minor effects over placebo, while older and smaller trials not restricted to patients with major depression showed marked effects. Compared with standard antidepressants Hypericum extracts had similar effects. CONCLUSIONS: Current evidence regarding Hypericum extracts is inconsistent and confusina. In patients who meet 

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Levels of evidence * Level I: obtained from at least one properly controlled randomized trial, considered the gold standard of evidence. * Level Il-1:derived from controlled trials without randomization. ~ Level Il-2: well-designed cohort or case- control studies. ~ Level Il-3: includes studies with external control groups or ecological studies. _ Level Ill evidence is derived from reports of expert committees, not because itis | weaker than levels | or Il, but because it is often difficult to ascertain the scientific origin of the committee opinion. 

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Ae iret ie Lec Lilie 5۷۲6۳۱۵1۱ ۷ Randomized Controlled Animal Research 

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Suggested Best Type of Study RCT > cohort > case control > case series Prospective, blind comparison to gold standard RCT > cohort > case control > (oT ‏اتب‎ Cohort study > case control > 00356 5 RCT > cohort study > case control > case series Prospective, blind comparison to gold standard Economic analysis لاد نظا ‎Question‏ ‎Therapy‏ ‎Diagnosis‏ ‎Etiology / Harm‏ ‎Prognosis‏ ‏۵ Clinical Exam 0051 مت ممعم ات ‎etiology‏ ۳۱۹۵ 0 

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In patient 105 or affect ‏اقا‎ [Interventi | [Comparis | [Outco [Patient/ on] on, if any] |me] Problem] \ Question: In adult with acute maxillary sinusitis, does a 3- day course of trimethoprim-sulfamethoxazole yield the same cure rates as a 10-day course, with fewer adverse effects and costs? OT emi BBY aN RCT>cohort>case control> Se ‏ک‎ case series 

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A 42-year old woman presented at the emergency room of the hospital complaining of muscle pain and tiredness. She was found to have hyperventilation and weakness of four limbs, with muscle power of grade 5 ()/5. All her symptoms gradually subsided over the next few hours. History revealed she was taking maqianzi', a herbal affect [Outcome 0 , if any] وگ دعوم کر ۱ ۱۱ ]۱۱۱۱۱۶2۱۱ Peacoat ‏وا و‎ cle) [Patient/ Problem] Question: In an adult woman, does magianzi cause muscle pain and tiredness? Type of study: (_RCT>cohort>case contraol> case series | Type of question: Etiology 

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affect [Outcome In patient with | does or [Patient/ [Intervention | [Comparison Been (ul ] , ‏[تقصة كأ‎ Question: In a postmenopausal woman is kidney yin deficiency as effective as standard tools in diagnosis of vasomotor symptoms? Type of study: Prospective blind comparison to gold standard :هادع نان 5ه عميا1 Diagnosis 

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لیر ee Cur) ‏وميد مولوعم ف‎ ۵۵۵۵ لاا ل لاقع بععمع لايع رای Cen) ‏5ع 5م 0 تا‎ يننا تال یات تا ۳ 5۷۱۲06۶65 fe ‏در‎ ‎۵۷۱۵۷ ۶ 5015 كناممء5 ب الضلقكء ,ل علطيام 

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If an original study is your best optio: 0 

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IMRAD format Introduction: why the authors decided to conduct the research. Methods: how they conducted the research and analyzed their results. Results: what was found. And Discussion: what the authors think ‏وت ییاتود‎ 

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PP-ICONS = Problem * Patient or population * Intervention = Comparison * Outcome = Number of subjects 0 Flaherty, Robert J. A simple mothod for evaluating the clinical literature, Fam Prac Mgt, May 2004:47-52. Available online at http://www.aafp.org/fpm/20040500/47asim html, 

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Scenario * You just saw a nine-year old patient with common warts on her hands. She is an ideal candidate for cryotherapy. Her mother has heard about treating warts with duct tape and wants to know if you would recommend this treatment. 

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Clinical question " What is your clinical question? = PICO: Patient, Intervention/Comparison, Outcome “In children with warts, is) duct tape as effective as cryotherapy Te) 2112۶۱۱۶۱۶۱۱۱۶۱۶ ٩۱۱۶ ۶ 

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Search " After you have your clinical question, search the appropriate databases: Dynamed, PIER, UpToDate, Cochrane, Clinical Evidence PubMed * Focht DR 3rd, Spicer C, Fairchok MP. The efficacy of duct tape vs cryotherapy in the treatment of verruca vulgaris (the common wert). Arch Pediatr Adolesc Med, 2002 

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Abstract 0 ou Oe ec sect a ete Rea a ‏کت ات تزا‎ meee CS اس لان ‎children.‏ SETTING: The general pediatric and adolescent clinics at a military medical center. PATIENTS: A total of 61 patients (age range, 3-22 years) were enrolled in the study ‏ا ل ل‎ ea NC RI EVES cla eis INTERVENTION: Patients were randomized using computer-generated codes to receive either cryotherapy (liquid nitrogen applied to each wart for 10 seconds every 2-3 weeks) ‏ا‎ Cs Ca) ‏اس یاس‎ Se EUR cal Wisi ONC) aU eer ec cre eee aM Celle et ete ۱ ‏رف‎ SM eRe eer ee Mar CSCO Reece Rak tas tape, and 25 (49%) were treated with cryotherapy. Twenty-two patients (85%) in the duct tape arm vs 15 patients (60%) enrolled in the cryotherapy arm had complete Reece ia rol et ken ON mL ‏ایا‎ ‏رد کر‎ ecole yg Ron TM Rear OUR Clea CONCLUSION: Duct tape occlusion therapy was significantly more effective than Ce ‏تسا‎ 

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Problem (?P-ICONS) * What is the clinical condition that was studied in the article? OBJECTIVE: To determine if application of duct tape is as effective as cryotherapy in the treatment of common warts. ~The problem studied should be sufficiently similar to your clinical problem, or the results will not be Porat Pat Wit at 

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Patient or Population (PP- ICONS) " Is the study group similar to your patient or practice? SETTING: The general pediatric and adolescent clinics at a military medical center. PATIENTS: A 3 of 61 patients (age range, 3-22 years) If the ‏دهدن‎ fn the study are not similar to your patient (older, sicker, different gender or more Clinically complicated), the results may not be 

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Intervention (PP-/CONS) * Is the intervention the same as what you are looking for? * Could be a diagnostic test or a treatment The patient’s mother has heard about treating warts with duct tape and wants to know if you would recommend this treatment. 

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Comparison (PP-ICONS) " The comparison is what the treatment is tested against. * Could be a different diagnostic test, another therapy, placebo, or no treatment at all. INTERVENTION: Patients were randomized using computer-generated codes to receive either cryotherapy (liquid nitrogen applied to each wart for 10 seconds every 2-3 weeks) for a maximum of 6 treatments or duct tape occlusion (applied directly to the wart) for a maximum of 2 months. 

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Outcome (PP-ICONS) " Disease-oriented outcomes (DOEs): usually reflect changes in physiologic parameters. * It has long been assumed that improving the physiologic parameters of a disease will result in a better outcome, but this is not = patieyeé-BHented evidence that matters (POEMs): look at outcomes such as morbidity, mortality and cost. = Therefore, DOEs are interesting but of questionable relevance, whereas POEMs are very interesting and very relevant. MAIN OUTCOME MEASURE: Complete resolution of the wart being studied. 

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Number (PP-ICONS) " Number of subjects in the study is crucial in whether accurate statistics can be generated from the data. * Too few patients may not be enough to show that a difference really exists between intervention and comparison groups (power - Pfanytslidies contain <100 subjects, which is usually inadequate to provide reliable ل ا ‎eich‏ 51 patients completed the study SCR AVC UR Mee rani Run es eee ee ere ce eee Bea aE eT 1970:30:607-610. 

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Statistics (PP-ICONS) " Relative risk reduction (RRR): the percent reduction in events in the treated group compared to the control ۱9۱۱۱۱۹۹ ‏ری را‎ tees ~ Amplifies small differences and makes insignificant findings appear significant ~ Doesn’t reflect the baseline risk of the outcome 3 898 weak results look good, therefore _ Popular and will be reported in almost every 5 1 ‏کل‎ mislead you RRR would be (85 percent - 60 percent/60 percent x 100 < 42 ۷ le. 42 nercent more effective than crvotherapv in 

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Statistics (PP-ICONS) * Absolute risk reduction (ARR): the difference in the outcome event rate between the control group and the experimental group. ARR for the wart study is the outcome event rate (complete resolution of warts) for duct tape (85 percent) minus the outcome event rate for cryotherapy (60 percent) = 25 percent _ A better statistic to evaluate outcome, as it does not amplify small differences, but shows the true difference between the experimental and control] interventions. 

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Statistics (PP-ICONS) Number needed to treat (NNT): number of patients who must be treated to prevent one adverse outcome OR the number of patients who must be treated for one patient to benefit * Single most clinically useful statistic * Easy to calculate, simply the inverse of the ARR. For the wart study, the NNT is 1/25 percent = 1/0.25 - 4 4 patients need to be treated with duct tape for ۱ ‏ره مرف رت ره ار ردیر درز‎ faeries) ofeSieeia) NNT of 10 or less is good, with less than 5 being very good _ For preventive interventions, the NNT willl be higher. A NNT for prevention of less than 20 might be particularly good. 

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Intention to Treat Analysis © Attrition: Were patients lost to follow-up, and ends acer Clem Nec lacie TaN eset according to the categories into which they were originally randomized. — Benefits of a treatment are more difficult to demonstrate with intention-to-treat analysis. — Helps to mitigate differences by including subjects who are unlikely to have experienced PCT ‏را وت و‎ RM ‏ار‎ Cie Mieco Coli OR aes patients). Worst case scenario: 6 cryotherapy patients had wart ‏اقنلأوع؟ فقط دوغأمعاغهم عمردغ غعيال 4 عغطاغ مصة صمأءسامدوع,‎ wart. Weve ater iam Mi Mole: aay eerie ‏ره اما ۵۸ که‎ اه اد دا کر و تس ‎Te Se Te‏ 3 

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Type of Study for Your 2-5 Question oe oe Masa MO ‏ما‎ ‏ا ا كا‎ ca ‏لكا ا‎ ar belie od (arta Or ernie eden ay ele eenes ‏تس سم‎ MO aks ied oA ae ce 5 00111 1 1 1 1 1 1 1 11 lon) Corre obsis OMe eae ‏ا الا ل‎ ee COUN 0 

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Assignment Identify a clinical problem with a patient Formulate a clinical question using PICO Search the literature for appropriate article(s) Evaluate the article(s) Complete the online assignment within two weeks after date of lecture. http://biomedicallibrary.southalabama.edu/library/? q=ebmrotationsassignment