Using evidence for patient care The EBM Approach “Just in time” and “Just in case” Angelo Tomedi, MD Department of Family and Community Medicine

Using evidence for patient care “Half of what you'll learn in medical school will be shown to be either dead wrong or out of date within five years of your graduation; the trouble is that nobody can tell you which half. So the most important thing to learn is how to learn on your own.” --- David Sacket (widely regarded as the father of evidenced-based medicine)

Using evidence for patient care About 40 percent of what we consider state-of-the-art health care is likely to turn out to be unhelpful or actually harmful. Vinayak K. Prasad and Adam S. Cifu. Ending Medical Reversal: Improving Outcomes and Saving Lives. September 2015

Using evidence for patient care OBJECTIVE: identify medical practices that offer no net benefits We reviewed all original articles published in 10 years (2001-2010) in one high-impact journal. Of the 363 articles testing standard of care, 146 (40.2%) reversed that practice, whereas 138 (38.0%) reaffirmed it. --- Prasad V, Vandross A, Toomey C, et al. A decade of reversal: an analysis of 146 contradicted medical practices. Mayo Clin Proc. 2013;88:790–8

“Just in time”: A question about pain relief from DJD A 67 year old female presents to clinic for follow-up of osteoarthritis of both knees. She has completed her course of physical therapy but continues to have pain that limits her activity. Acetaminophen did not help, and ibuprofen caused abdominal pain and worsened her HTN and CKD. Steroid injections provided only temporary relief. She would like something to alleviate her pain.

“Just in time”: A question about pain relief from DJD You are considering tramadol, but your attending suggests a topical NSAID (ee.g. diclofenac), which you have never prescribed and are skeptical that a topical medication would be effective. You reluctantly prescribe diclofenac gel to humor your attending but decide to search for evidence of efficacy (or lack thereof).

The EBM Process Ask a focused clinical question (PICO format) Search for the best evidence to answer the question Critically appraise the evidence Apply the evidence to the patient

Clinical question PICO question: Patient Intervention Comparison intervention (e.g. placebo, another intervention) Outcome (preferably a clinical outcome)

Clinical vs Surrogate outcomes ACCORD trial: patients with type 2 diabetes were randomly assigned to intensive or standard glycemic control. After a median follow-up of 3.7 years, intensive therapy median A1C was 6.4 compared with the standard-treatment group median of 7.5 percent.

Clinical vs Surrogate outcomes ACCORD trial: The study was stopped early due to a higher number of total and cardiovascular deaths in the intensive therapy compared with the standard-treatment group

Clinical vs Surrogate outcomes ALLHAT trial of over 41,000 patients with mild hypertension and at least one other risk factor for coronary heart disease found that low-dose chlorthalidone was associated with fewer cardiovascular complications than amlodipine and lisinopril. BP control was similar in all arms of the study.

Clinical vs Surrogate outcomes ALLHAT trial: The doxazosin arm was discontinued early because of a higher rate of adverse cardiovascular outcomes (stroke and combined CVD). The difference in clinical outcomes was not explained by a difference in the surrogate outcome of BP change.

Clinical question PICO question: Patient: 67 y.o. female with knee DJD Intervention: topical NSAID Comparison intervention: placebo or tramadol Outcome: pain relief, improved function

The EBM Process Ask a focused clinical question Search for the best evidence to answer the question Critically appraise the evidence Apply the evidence to the patient

Levels of evidence: Therapy/Prevention Systematic reviews (with homogeneity) of RCTs Individual RCT (with narrow confidence interval) Systematic review of cohort studies Individual cohort study Outcomes research SR (with homogeneity*) of case-control studies Individual Case-Control Study Case series Expert opinion

Search strategy for articles about Therapy/Prevention Search for highest levels of evidence first: Systematic reviews of RCTs Individual RCT (with narrow confidence interval)

Search for the Evidence Cochrane library of systematic reviews Pubmed “Clinical Queries”: Systematic Review or RCT

Search for the Evidence

Search for the Evidence Topical NSAIDs for chronic musculoskeletal pain in adults. 22 April 2016 “Topical diclofenac and topical ketoprofen can provide good levels of pain relief beyond carrier in osteoarthritis…..” “With topical diclofenac, the NNT for clinical success in six trials (2343 participants) was 9.8”

Search for the Evidence

Search for the Evidence Tramadol for osteoarthritis. July 2006 “Tramadol or tramadol/paracetamol decreases pain intensity, produces symptom relief and improves function, but these benefits are small…” “Participants who received tramadol had 2.27 times the risk of developing minor adverse events and 2.6 times the risk of developing major adverse event…”

EBM Process Ask a focused clinical question Search for the best evidence to answer the question Critically appraise the evidence Apply the evidence to the patient

Critical Appraisal of Systematic Reviews Three sets of questions to answer Are the results valid? What are the results? How can I apply the results to patient care?

Evidence-Based Medicine Keeping abreast of the medical literature: “Just in case”

Evidence-Based Medicine The journal Evidence-based Medicine is available full text from UNM HS Library web page. Under “Worldcat” tab, click on “E-journal” and enter “evidence based medicine” in the “Title” search box, click on “search,” click on “evidence based medicine.”

EvidenceAlerts “EvidenceAlerts” is a collaboration of DynaMed Plus and McMaster University's Health Information Research Unit. Articles are chosen from “over 110 premier clinical journals,” are pre-rated for quality then rated for clinical relevance and interest. It’s FREE! Web site: https://plus.mcmaster.ca/EvidenceAlerts/

POEMs POEMs (“Patient-Oriented Evidence that Matters”) Research Summaries are synopses of new evidence filtered for relevance to patient care and evaluated for validity. Reviews and appraises 3000+ studies published monthly in more than 100 journals. Database of EssentialEvidence Plus Web site: https://www.essentialevidenceplus.com/product/features_ir.cfm?show=infopoems/