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Clinical Inquiries. Summarizing Evidence. Clinical Inquiries. Structured review summary of best evidence to answer a clinical question. Ways to Summarize Information. Narrative Descriptive text Descriptive tables Descriptive graphical displays. Quantitative Meta-analysis Forest plots
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Clinical Inquiries Summarizing Evidence
Clinical Inquiries Structured review summary of best evidence to answer a clinical question Ways to Summarize Information • Narrative • Descriptive text • Descriptive tables • Descriptive graphical displays • Quantitative • Meta-analysis • Forest plots • Other graphical displays
Systematic Reviews vs. Meta-Analyses • Systematic Review • A summary of the medical literature that uses explicit methods to perform a comprehensive literature search and critical appraisal of individual studies • Results are too heterogeneous to “pool” and analyze as a single data set • Meta-Analysis • A systematic review that uses quantitative methods to synthesize and summarize the results • Results are homogeneous enough to “pool” and analyze as a single data set Center for Evidence-Based Medicine http://www.cebm.net/index.aspx?o=1116
CI Evidence Summaries • FPIN does not encourage meta-analyses nor systematic reviews • Why? • FPIN CIs are not completely methodologically rigorous reviews • Methods underdeveloped for some study types • Requires specialized statistical training • Takes too much time and publication space • FPIN does encourage careful critical appraisal of all types of relevant evidence, including meta-analyses, systematic reviews, and other study designs
Evidence Summary Pitfalls • Failing to critically appraise systematic reviews and meta-analyses with the same rigor as individual studies • Failing to give enough detail for the reader to gauge the validity of studies • Failing to describe how the various study results relate to the question as a whole
Evidence-Based Answer • Authors “grade” each reference using the CEBM Level of Evidence (LOE) (see FPIN web site for this grading system) • Authors then convert CEBM LOEs to SORs using a “walkover” process (see table in 2 slides) • Authors use Strength of Recommendation Taxonomy (SOR) and a brief description of the basis for the statement. (see next slide for examples)
Evidence-Based Answer • Example SORs: • SOR A, based on multiple RCTS • SOR B, based on a prospective cohort study in a referral population • SOR C, based on expert opinion and uncontrolled prospective cohort study
Evidence Summary • Evidence summary (ES) section gives a brief background and succinctly describes the relevant evidence • ES Includes information about study design and/or study quality • Can use a table to concisely convey detailed information
Examples from a CI Evidence Summary • “A systematic review of 9 heterogeneous studies evaluating TVS found wide ranges for sensitivity and specificity (TABLE).” • “In a double-blinded comparative study of 106 consecutive premenopausal women undergoing hysterectomy for benign reasons, MRI and TVS detected myomas with equal precision (TABLE).” Griffin KW, Ellis MR, Wilder L. What is the appropriate diagnostic evaluation of fibroids? JFP 2005;54:458-62.
CI Tables Griffin KW, Ellis MR, Wilder L. What is the appropriate diagnostic evaluation of fibroids? JFP 2005;54:458-62.
Transparency: Describing Study Designs • BAD: “Pratchett, et al, showed…” • BETTER: “In a recent RCT comparing albuterol and azithromycin…” • BEST: “In a 2009 randomized, double-blind, double dummy comparison trial of albuterol and azithromycin…”
Transparency: Describing the Group • BAD: “Patients received…” • BETTER: “Three hundred sixteen patients received…” • BEST: “Three hundred sixteen adult patients (mean age 47 years old) received…”
Transparency: Describing Interventions • BAD: “…magnesium sulfate or placebo.” • BETTER: “magnesium sulfate 430 mg daily or placebo” • BEST: “…oral magnesium sulfate 430 mg once daily or placebo for 6 weeks”
Transparency: Describing Outcomes • BAD: “Patients in the active treatment group did better overall” • BETTER: “Patients in the active treatment group had 80% less cough than the placebo group (P<0.01)” • BEST: “Patients in the active treatment group had significantly less cough than the placebo group (weighted mean difference 0.2; 95% CI, 0.1 - 0.3)”
Next Steps • Complete your review of the evidence • Outline the key findings from included studies that you want to highlight in the “Evidence Summary” section • Develop one or more recommendations from the “Evidence-Based Answer” section • Assign Strength of Recommendation to each recommendation statement • Make sure that each Evidence-Based Answer recommendation is supported with information in the Evidence Summary section
Questions? Contact the CI Project Manager Lindsay Barnes Lindsay@fpin.org (573) 256-2066