Objectives. Evidence-Based Practice. Why Evaluate Research Literature? Critical Appraisal

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1 Objectives 2 Outline key elements of research critique Apply select principles of critique to published reports of research REVIEWING AND CRITIQUING RESEARCH LITERATURE A CASE-BASED APPROACH Why Evaluate Research Literature? Evidence-Based Practice 3 4 Judge studies trustworthiness Understand reliability and relevance for practice Make objective decisions about patient care Make sense of the results AND/OR Learn research process and state of knowledge for own studies. Conscientious use of current best evidence in making decisions about patient care. a problem-solving approach to clinical practice that integrates: A systematic search for and critical appraisal of the most relevant evidence to answer a burning clinical question One s own clinical expertise Patient preferences and values. Melnyk & Fineout-Overholt Current, best evidence : Hierarchy of Evidence (one model) Critical Appraisal 5 6 Systematic process Application of rules of evidence Specific to type of evidence KEY: Appropriateness of study design for research question Soundness of method to reduce bias

2 Research Question and Design EBP Begins with PICO Question 7 Question What is happening? To whom and in what proportion is it happening? When does it happen? Design Descriptive/Correlational (Qualitative) atient population or problem ntervention of interest Is this treatment effective? Experimental omparison intervention utcome of interest Example: Rx for Mucositis Example 9 atients with leukemia undergoing chemo Sodium bicarb mouthwash Chlorhexidine mouthwash Mucositis and bacterial colonization Hierarchy of Evidence 11

3 Rapid Critical Appraisal CASP RCT Checklist Are the results of the study valid? 2. What are the results? 3. Will the results help in caring for my patient? 1. Are the Results of the Study Valid? 2. What Are the Results? Did the trial address a clearly focused issue? Was the assignment of patients to treatments randomized? Were all of the patients who entered the trial properly accounted for at its conclusion? Were patients, health workers and study personnel blind to treatment? Were the groups similar at the start of the trial? Were the groups treated equally (except for the intervention)? How large was the treatment effect? How precise was the estimate of the treatment effect? the existence of a [statistically significant] treatment effect has no bearing on its size, importance, or clinical significance. (Jacobson & Traux, 1991) Will the Results Help Locally? 18 Can the results be applied to my patients? Did the trial address a clearly focused issue? Were all clinically important outcomes considered? Are the benefits worth the harms and costs? oral mucositis is one of the most debilitating side effects of cancer treatment.the severity of oral mucositis varies from redness or edema of oral mucous membranes to ulcerative lesions These lesions are accompanied with considerable pain and seriously hinder eating and drinking. this study was conducted to evaluate the effectiveness of oral care using the SB solution and CHX mouthwash on the oral health and the risk of infection in acute leukemic patients.

4 19 Was the assignment of patients to treatments randomized? Participants were randomly assigned to the SB group or the CHX group according to acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL). 20 Were all of the patients who entered the trial properly accounted for at its conclusion? Twenty-three individuals were required per group; however, 32 individuals per group were aimed for, taking into account a predicted 30% drop out rate. The participants who met the above criteria and agreed to participate in the study were 31 in the SB group, 37 in the CHX group in the beginning. However, 7 in the SB group,13 in the CHX group dropped out during the study Therefore, only 48 participants (24 in the SB group and 24 in the CHX group completed the entire study. 21 Were patients, health workers and study personnel blind to treatment? (Not addressed) 22 Were the groups similar at the start of the trial? Participants were assigned to one of the two groups by block randomization; the blocks were divided according to AML or ALL, and random sampling numbers were used in each block. The mean ages of the SB and CHX groups were 37.4 and 40.5 years, respectively. Men comprised 54.2% of the SB group and 66.7% of the CHX group. In the SB and CHX groups, AML patients represented 62.5% and 62.5% of the total, respectively. The remaining patients in both groups had ALL (37.5% each). Aerobic bacteria of the SB and CHX groups at admission measured 6.3 and 6.0 colony forming units (CFU)/mL, respectively. Anaerobic bacteria of the SB group at admission measured 6.5 CFU/mL and 6.3 CFU/mL for the CHX group. No significant differences in demographic, clinical, or microbiologic characteristics between the two groups were observed Were the groups treated equally (except for the intervention)? Yes How large was the treatment effect? Effect size (Cohen s d) formula: Mean of Exp group Mean of control group pooled SD (Cohen s d of 0.2 small, 0.5 medium, 0.8 large) Online effect size calculator: Results for mouth soreness (week 3): 0.7 in SB and 1.5 in CHX; Cohen s d =.76

5 25 26 How precise was the estimate of the treatment effect? confidence interval for descriptive study More easily calculated from binary outcomes in exp. study If the results are valid: Can the results be applied to my patients? Inclusion/exclusion criteria, e.g., comorbidities Description of sample demographics Setting Etc If the results are valid: Were all clinically important outcomes considered? How measured (validity, etc.) Self-reported vs. objective Timing of measurement If the results are valid: Are the benefits worth the harms and costs? CEA/cost benefit ratio Hospital policies, e.g., SB rinse Change process Yoga and Atrial Fibrillation 29 30

6 EBP Begins with PICO Question Hierarchy of Evidence 32 atients with atrial fibrillation Yoga training + standard care Standard care alone Symptoms and AF episodes 1. Are the Results of the Study Valid? 34 Did the trial address a clearly focused issue? Was the assignment of patients to treatments randomized? Were all of the patients who entered the trial properly accounted for at its conclusion? Were patients, health workers and study personnel blind to treatment? Were the groups similar at the start of the trial? Were the groups treated equally (except for the intervention)? What Are the Results? 3. Will the Results Help Locally? How large was the treatment effect? How precise was the estimate of the treatment effect? Can the results be applied to my patients? Were all clinically important outcomes considered? Are the benefits worth the harms and costs?

7 37 Conclusion Skills improve with practice Other types of studies have different appraisal criteria Any research should be evaluated according to 3 things: 1. Validity 2. Results 3. Relevance 38 References Choi, S., & Kim, H. (2012). Sodium bicarbonate solution versus chlorhexidine mouthwash in oral care of acute leukemia patients undergoing induction chemotherapy: A randomized controlled trial. Asian Nursing Research, 6(2), Jacobson, N. S., & Truax, P. (1991). Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. Journal of Consulting and Clinical Psychology, 59(1), doi: / x Lakkireddy, D., Atkins, D., Pillarisetti, J., Ryschon, K., Bommana, S., Drisko, J., Vanga, S., & Dawn, B. (2013). Effect of yoga on arrhythmia burden, anxiety, depression, and quality of life in paroxysmal atrial fibrillation: The YOGA my heart study. Journal of the American College of Cardiology, 61(11), doi: /j.jacc Melnyk, B.M., & Fineout-Overholt, E. (2010). Evidence-based practice in nursing and healthcare (2 nd edition). New York: Lippincott, Williams & Wilkins. Safer, D. L., & Hugo, E. M. (2006). Designing a control for a behavioral group therapy. Behavior Therapy, 37(2),