Is it True: Evaluating Medical Reviews “The review article itself should be the product of scientific investigation in which the participants are original investigations (research) rather than patients” Usefulness Work: Low, good source for POEMs Relevance: If title and abstract or article conclusion hold promise of POEM, continue Validity: Uncertain Reviews- Three Basic Types Textbooks Academic Reviews “Translation” Journals Textbooks Collection of review articles Minimal, if any, supporting evidence Questionable validity, long lag time to publish • Average 1-2 years Most useful for retracing, less hunting and foraging Academic Reviews Summary: “Broadly paint landscape” Validity uncertain- begin with conclusions and find supporting references References often inaccurate and out of date **Expertise of author varies inversely with quality of review- Oxman/Guyatt** • More later Must confirm POEMs with original research, increasing work Academic Reviews Synthesis: Systematic reviews Answer one or two specific questions Review primary literature with strict criteria • Meta-analysis or overviews Conclusions supported by available evidence Meta-analysis: Achieve power not possible by single study Academic Reviews Excellent source for hunting and foraging The Cochrane Library - “Database of Systematic Reviews” Clinical Evidence (BMJ-BMA) Clinical Inquiries (FPIN)- SORT AFP EB Reviews- SORT Dynamed - SORT Essential Evidence Plus- SORT Translation Journals Quick reads for retracing and sporting Low work, but with low validity, may be zero usefulness Hunting/foraging: Entering jungle on starless night Translation Journals Common POEMs need original data for verification, greatly increasing work Watch for “weasel words”, based on DOEs and anecdotes • “it seems”, “may be effective”, “so one may assume”, “it appears”, “in my experience” Weasel Words Translation Journals “Buyer Beware: Unsystematic reviews lead to unsystematic conclusions. Readers looking for a shortcut to understanding evidence about health problems and patient care should at least look for reviews by those who have not taken shortcuts” Determining the usefulness of reviews Onto the worksheets! Reviews: Determining Relevance A. Addressing specific clinical question? A. Patient-oriented evidence? B. Common problem? C. Change your practice? Reviews: Determining Validity Answer ALL worksheet questions Stop = “fatal flaw” Notice how hard this is! Average time for a good systematic review- 2 years! • Much different from your “usual review/CME talk” Worksheet Qs: Finding the studies Clearly stated? • Comprehensive? • • • Terms appropriate? MESH-linked? None missing? Medline + another • MEDLINE misses >50% of articles • Cochrane registry is especially good source • Science Citation Index Bibliographic review Unpublished literature • conference abstracts, personal correspondence with important investigators or pharmaceutical companies Done by more than one person and compared Worksheet Qs: Selecting the studies Inclusion Criteria • • • • Established a priori Minimum factors: Population/problem; intervention/comparison; outcomes; study design Prefer no language restriction Sometimes validity criteria incorporated (random, blinded, appropriate follow-up, gold standard, etc.) Best if done independently by 2 investigators • Possibly blinded to author/journal/study results Worksheet Qs:Validity of included studies Appropriate criteria? • • Assurance that criteria specific to type of article employed (therapy, diagnosis, prognosis, etc) If therapy: randomization, blinding, concealed allocation, follow-up Process independent by > 2 authors? • • Surprising differences! Why blinding may be important: • 2 sample articles, same study methods • One finds benefit, other does not • “serious flaws” in article without benefit Worksheet Qs: Validity Were the included studies valid? • Garbage in = garbage out • If yes, no problem • If no, how did authors handle this? • Exclusion/inclusion criteria for quality of study • Subanalysis with comparison of results • Need to consider how these flaws affect results/conclusions Worksheet Qs: Analyzing the data Homogeneity vs Heterogeneity: just finding the words and an explanation most important If NOT homogeneous? • Need qualitative explanation. Is it due to chance vs study design, population, exposure, or outcome? Worksheet Qs: Analyzing the data Appropriateness of combining data: • • • “Vote” count not usually appropriate Important to include ‘magnitude’ of the overall effect Cannot be done without some common ground- outcome Publication bias • • • Small, negative trials less likely to be published Examined by funnel plot Number needed to change results Funnel plot examples From: Cooper & Hedges: The handbook of research synthesis. 1994 From: Cooper & Hedges: The handbook of research synthesis. 1994 Reviews: Major Points Validity traps to avoid • • Assertions based on DOEs -- avoid perpetuating medical gossip Unassessed validity -- Personal experience unreliable as a basis for therapeutic interventions Missing pieces -- **Quality of the review varies inversely with the expertness of the writer** Failure to identify level of evidence – Look for LOE’s/ SORT Reviews- Three Basic Types Effect on Patient-Oriented Outcomes Symptoms Functioning Quality of Life Lifespan Effect on Disease Markers Diabetes (microalbuminuria, GFR, photocoagulation rates) Arthritis (ESR, x-rays) Peptic Ulcer (endoscopic ulcers) SORT B SORT A SORT C Effect on Risk Factors for Disease Improvement in markers (blood pressure, HbA1C, cholesterol) Uncontrolled Observations & Conjecture Physiologic Research Preliminary Clinical Research Case reports Observational studies Validity of Evidence Highly Controlled Research Randomized Controlled Trials Systematic Reviews