1/12/2016 OBJECTIVES WHAT IS EVIDENCE-BASED MEDICINE (EBM)? 5 STEP PROCESS PICO: PATIENT, INTERVENTION, COMPARISON, OUTCOME

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1 EVIDENCE-BASED MEDICINE: THE QUEST FOR YOUR DRUG INFORMATION REQUEST OBJECTIVES ) Define the clinical question. ) Recognize how to retrieve pertinent literature. ) Express how to evaluate said literature. ) Classify quality of literature. ) Describe conclusions and recommendations. Jocelyn Van Vickle, Pharm.D., PGY- resident Reid Grobe, Pharm.D., PGY- resident WHAT IS EVIDENCE-BASED MEDICINE (EBM)? STEP PROCESS Systematic approach Integrating BEST scientific evidence with clinical judgment/expertise Involves: Staying current Solving problems Making best clinical decisions Define the clinical question Recognize how to retrieve pertinent information Express how to evaluate the literature Classify the quality of literature Describe conclusions and recommendations DEFINE THE CLINICAL QUESTION Importance: in order to answer the question, you must know what your inquirer is asking Context Scope of the issue/problem PICO: PATIENT, INTERVENTION, COMPARISON, OUTCOME P- Patient, problem or population Either the patient's chief complaint or generalize the patient's condition to a larger population. Questions to ask: How could you describe a group with a similar problem? How you would describe the patient to a colleague? What are the important characteristics of this patient?

2 PICO: PATIENT, INTERVENTION, COMPARISON, OUTCOME I- Intervention Main consideration for the patient/client Questions to ask: What will you do for the patient? Diagnostic tests, treatments, adjunctive therapies, medication or the recommendations to the patient to use a product or procedure? PICO: PATIENT, INTERVENTION, COMPARISON, OUTCOME C- Comparison The main alternative in consideration Specific and limited in order to facilitate an effective approach Sometimes there are no comparisons PICO: PATIENT, INTERVENTION, COMPARISON, OUTCOME O- Outcome What is accomplished with answering the question? Specific outcomes yield a better search Questions to consider? HOW? QUESTION # PICO is an acronym used to aid in the completion of which step in the evidence-based medicine process: A. Step B. Step C. Step D. Step QUESTION # What does the acronym PICO stand for? A. Place, Incidence, Comparison, Outcome B. Patient, Intervention, Comparison, Outcome C. Patient, Intervention, Completeness, Outcome D. Patient, Intervention, Comparison, Outliers STEP PROCESS Define the clinical question Recognize how to retrieve pertinent information Express how to evaluate the literature Classify the quality of literature Describe conclusions and recommendations

3 RETRIEVE PERTINENT INFORMATION TERTIARY DATA o Different types of resources: Tertiary Secondary Primary Big Picture information Overview/Summaries What is the purpose? Basic information about the topic you are researching Check citations for other resources ELECTRONIC TERTIARY RESOURCES Compendia Lexi-Comp Clinical pharmacology efacts (Facts and Comparisons) Micromedex Natural Standard Natural Medicines Comprehensive Database Electronic textbooks Stat!Red AccessMedicine General information UpToDate DynaMed Cochrane Database of Systemic Reviews MDConsult Consumerlab.com NIH Office of Dietary Supplements Pharmacist s Letter Medscape FDA CDC National Guideline Clearinghouse ClinicalTrials.gov PRINT TERTIARY RESOURCES American drug Index Handbook of Injectable Drugs American Hospital Formulary Service Hansten and Horn s Drug Interactions Cecil s Harrison s DeVita s Immunofacts Drug Interaction Facts Kings Guide to Parenteral Admixtures Drugs in Pregnancy and Lactation Mandell s Remington s SECONDARY RESOURCES PRIMARY RESOURCES Aid in finding new information Tools that point the user to the primary sources makes searching for primary literature much easier Examples: International Pharmaceutical Abstracts (IPA) EMBASE Medline Pubmed Google Scholar Original data and ideas NEW information First published record of investigation Often, most current information Examples: Research articles/trials, case studies

4 MOST IMPORTANTLY QUESTION # Always double check your sources!!! Which type of resource is utilized to retrieved original materials and information? A. Primary B. Secondary C. Tertiary D. A & B STEP PROCESS Define the clinical question Recognize how to retrieve pertinent information Express how to evaluate the literature Classify the quality of literature Describe conclusions and recommendations TRIAL DESIGN What is being measured? efficacy vs effectiveness/efficaciousness Are there methods to reduce bias? Is the trial blinded vs open-label? What is the trial s sample size and statistical power? PRIMARY RESEARCH QUESTION Definition: uncertainty of what the investigator would like to resolve. Single primary question around which to focus the development of the trial Importance of understanding the research question: investigators use this to develop a hypothesis INTERVENTIONAL CLINICAL TRIALS ) Superiority: determine if one is better than another ) Non-inferiority: determine is one is no worse than another ) Equivalency: prove that a new drug is therapeutically similar to the control drug (*do NOT see as often)

5 HYPOTHESIS FOR SUPERIORITY TRIALS HYPOTHESIS FOR NON-INFERIORITY TRIALS Null Hypothesis Alternative Hypothesis Null Hypothesis Alternative Hypothesis Hypothesis to be tested Difference between treatments are NOT statistically significant Hypothesis to be accepted if the null hypothesis is rejected The difference between the treatments is statistically significant No statistical significance is seen Inconclusive Test drug may be inferior to the reference drug Statistical significance is seen Test drug is non-inferior to the reference drug Trial Outcomes No difference is seen between the treatment groups Difference is seen between the treatment groups Language Used Fail to reject the null hypothesis Reject the null hypothesis Trial outcomes The difference is NOT statistically significant The difference is statistically significant Language Used Failure to reject the null hypothesis Reject the null in favor of the alternative hypothesis TYPE OF TRIAL OBSERVATIONAL Investigators will observe effects Wait and see Importance: Gather a lot of information Analyze patterns INTERVENTIONAL Investigators make deliberate changes or interventions Importance: Able to observe effects for a particular change Determine cause and effect relationship OBSERVATIONAL TRIALS: COHORT Prospective (or retrospective from archived records) Exclude people with the outcome investigators are looking for One group, subdivided into those with a risk factor (variable of interest) and those without Observe over time for differences in contraction of an outcome related to the research question OBSERVATIONAL: CASE CONTROL OBSERVATIONAL: CROSS SECTIONAL Retrospective Match a person (case) with an outcome of interest to a similar person without that outcome and look for particular differences in variables Moment in time AKA: prevalence study A blend of cohort and case control Begins with a population (cohort) and makes simultaneous assessment of outcomes, descriptive features and potential predictors

6 TYPE OF TRIAL CHARACTERISTICS OF TRIAL PROSPECTIVE RETROSPECTIVE Forward in time gather data as it happens All interventional trials are prospective Backward in time gathering data from historical documentation Pulling information from charts Uncontrolled Controlled CHARACTERISTIC OF TRIAL TRIAL TIME TABLE Randomized Two or more groups Groups should be very similar afterward Stratification Non-randomized May be one or more groups Individuals are assigned to a group based on certain traits by chance of investigator Groups may not be similar Term Definition Utility Run-In Follow-up Period before a trial starts when no treatment is given Monitoring of the patients health over time after treatment has ended Get rid of the high placebo responders that could impair future results Keep track of long term effects of the drug being investigated. TREATMENT GROUPS TREATMENT GROUPS PARALLEL Two or more groups having difference experiences at the same time CROSS-OVER One group having two or more experiences at different times Run-in Drug A Wash-out Drug B Follow-up Bigger groups Run-in Drug A Randomization Follow-up Smaller groups Need a washout period (x half life) to ensure drug is removed Drug B Drug A Drug B 6

7 BLINDING SUBJECTS BLINDED UNBLINDED INCLUSION CRITERIA EXCLUSION CRITERIA Single: either patient or investigator knows assignment Double: neither patient not investigator knows assignment More objective results Investigators and patients know what group the study patient is in Observations or experiences may be reported due to interpretations Primarily aids in addressing the hypothesis Fine-tuning Specific; categorize the patients PATIENT SAFETY Primarily aids in reducing risk and complications for the patients LOCATION OTHER CHARACTERISTICS OF TRIAL DESIGN # Sites Pros Cons Single Ease of communication between investigators Ease of data collection Easy to organize Minimize variability Smaller number of patients Multiple Larger patient population is possible Challenge of coordinating researchers and protocols All determined before the study begins: Sample size Data analysis Follow-up period ULTIMATE GOALS OF TRIAL DESIGN EVALUATING TRIAL DESIGN Obtain optimum data to address research hypothesis Minimize effect of error, outside influence and confounders Obtain data efficiently and ethically Often times, multiple item checklists are utilized to evaluate the literature, especially when teaching students Check lists can be lengthy Ten Major Considerations Aid in evaluating the integrity of the article Reduce the amount of time spent on a multi-item checklist when evaluating literature Extra considerations for non-inferiority trials 7

8 TEN MAJOR CONSIDERATIONS. Power set/met (Power has to be met in order for the trial to be of the highest quality, Level ). Dosage/treatment regimen appropriate. Length of the study appropriate to show effect. Inclusion criteria adequate. Exclusion criteria adequate 6. Blinding present 7. Randomization resulted in similar groups 8. Biostatistical tests appropriate for type of data analyzed 9. Measurement (s) standard/ validated/accepted in practice 0. Author s conclusions are supported by the results EXTRA CONSIDERATIONS FOR NON-INFERIORITY TRIALS Was the study design originally intended to be a non-inferiority trial? How was the non-inferiority margin determined? What patient population was used to analyze the primary outcome for noninferiority? Which of the following confounding factors were noted for this trial? ABBREVIATED BIOSTATS POWER Power Alpha level P- value Type I and II error Calculation that indicated whether or not a study can accurately detect a statistically significant difference between samples when a difference does exists. If a study does not meet power, that is a major limitation Power = β β usually < 0. LEVEL OF SIGNIFICANCE: ALPHA P- VALUE Alpha is set by the investigator Results are considered statistically significant if they fall below this level of significance Often set at 0.0 Can be set lower Alpha (level of significance) is necessary to interpret the P-value P-value describes the probability that differences between the two groups are due to chance P-values are obtained from statistical tests Results are considered statistically significant is their value falls below the alpha. 8

9 TYPE I & II ERRORS QUESTION # Type Error Setting the alpha establishes the probability of making a Type error False Positive Incorrectly rejects the null hypothesis Say there is a difference when one does not exist Type II Error Setting Beta establishes the probability of making a Type II error False Negative Incorrectly fails to reject the null hypothesis Say there is no difference when there may be a difference Often associated with too small of a treatment population What is the null hypothesis? A. The hypothesis to be tested B. The hypothesis to be accepted C. Excluding results based on the primary outcome D. Patients that dropped out QUESTION # STEP PROCESS What is type II error? A. Excluding patients that should be included B. Finding a difference when there really isn t one C. Using the wrong study design D. Determining there isn t a difference when there could be one Define the clinical question Recognize how to retrieve pertinent information Express how to evaluate the literature Classify the quality of literature Describe conclusions and recommendations QUALITY OF LITERATURE Recall characteristics of clinical trials we discussed earlier:. Interventional. Observational. Controlled. Non-controlled. Randomized 6. Non-randomized 7. Power 8. No power LEVEL OF EVIDENCE Does the study have an intervention or is it strictly observational? *These will aid in determining the level of evidence which the trial provides 9

10 LEVEL OF EVIDENCE LEVEL OF EVIDENCE Does the study have a control group? Does the study have a cohort group, and if so, is it prospective or retrospective? LEVEL OF EVIDENCE LEVEL OF EVIDENCE Is the study randomized? If randomized and controlled, does the study meet power? QUESTION #6 What is a level III study? A. Randomized controlled interventional study B. Prospective cohort not randomized C. Retrospective cohort STEP PROCESS Define the clinical question Recognize how to retrieve pertinent information Express how to evaluate the literature Classify the quality of literature Describe conclusions and recommendations 0

11 DRAWING CONCLUSIONS Summarize all of the evidence gathered Utilizing the level of evidence table, be able to categorize the grade of recommendation GRADE OF RECOMMENDATION Grade A: Strongest recommendation. These are based on level trials. Level trials HAVE to meet power Grade B: Not as strong as A. Recommendations come from Level trials. Grade C: Be cautious with these recommendations. DEVELOPING A RECOMMENDATION. Sort by level of evidence. Organize all of the data collected.. Summarize the HIGHEST quality of evidence.. Grade the recommendation. Make a recommendation for the specific patient, not just for the general population. ASPECTS OF A RECOMMENDATION Efficacy Level of evidence Results Clinical significance Safety Adverse effects: most common and most detrimental Cost Associated with studied medications and healthcare in general Other misc. considerations/special populations QUESTION #7 QUESTION #8 What is the first thing that should be done when answering a DI question? A. Go straight to wiki for the answers B. Begin a literature search C. Determine the scope and context of the question D. Analyze the latest data A literature search yields two studies with conflicting results. One study is a randomized, controlled interventional study, the other is a prospective cohort. What results do you include in your answer? A. The prospective cohort, it is a higher level of evidence B. The RCT it is a higher level of evidence C. Both and let the inquirer decide D. Neither restart your literature search

12 QUESTION #9 STEP PROCESS Which is an example of a tertiary resource? A. JAMA B. NEJM C. UpToDate D. PubMed Define the clinical question Recognize how to retrieve pertinent information Express how to evaluate the literature Classify the quality of literature Describe conclusions and recommendations RESOURCES ) What is Evidence-Based Practice. Duke University Medical Center; 0; retrieved from: ) Sackett DL, Richardson WS, Rosenberg W, Haynes RB (997). Evidence-based medicine: How to practice and teach EBM. New York: Churchill Livingston. ) Bryant P, Pace H. The Pharmacist s Guide to Evidence-Based Medicine for Clinical Decision Making. American Society of Health System Pharmacists. 008 QUESTIONS? Thank you!

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