Evidence-based surgery : a gudie to understanding and interpreting the surgical literature PDF
Preview Evidence-based surgery : a gudie to understanding and interpreting the surgical literature
Evidence-Based Surgery A Guide to Understanding and Interpreting the Surgical Literature Achilles Thoma Sheila Sprague Sophocles H. Voineskos Charles H. Goldsmith Editors Evidence-Based Surgery Achilles Thoma Sheila Sprague (cid:129) Sophocles H. Voineskos Charles H. Goldsmith Editors Evidence-Based Surgery A Guide to Understanding and Interpreting the Surgical Literature 123 Editors Achilles Thoma CharlesH.Goldsmith Department ofSurgery, Divisionof DepartmentofHealthResearchMethods, Plastic Surgery, Departmentof Health Evidence andImpact (HEI) Research Methods,Evidence McMaster University andImpact (HEI) Hamilton, ON,Canada McMaster University Faculty of HealthSciences Hamilton, ON,Canada Simon FraserUniversity Burnaby,BC,Canada Sheila Sprague Department ofSurgery, Divisionof Department ofOccupational Science Orthopaedic Surgery, Department of andOccupational Therapy, HealthResearch Methods, Evidence Faculty of Medicine andImpact (HEI) TheUniversity of BritishColumbia McMaster University Vancouver, BC,Canada Hamilton, ON,Canada SophoclesH.Voineskos Department ofSurgery, Divisionof Plastic Surgery McMaster University Hamilton, ON,Canada ISBN978-3-030-05119-8 ISBN978-3-030-05120-4 (eBook) https://doi.org/10.1007/978-3-030-05120-4 LibraryofCongressControlNumber:2018963289 ©SpringerNatureSwitzerlandAG2019 Thisworkissubjecttocopyright.AllrightsarereservedbythePublisher,whetherthewholeor part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations,recitation,broadcasting,reproductiononmicrofilmsorinanyotherphysicalway, andtransmissionorinformationstorageandretrieval,electronicadaptation,computersoftware, orbysimilarordissimilarmethodologynowknownorhereafterdeveloped. Theuseofgeneraldescriptivenames,registerednames,trademarks,servicemarks,etc.inthis publication does not imply, even in the absence of a specific statement, that such names are exemptfromtherelevantprotectivelawsandregulationsandthereforefreeforgeneraluse. Thepublisher,theauthorsandtheeditorsaresafetoassumethattheadviceandinformationin thisbookarebelievedtobetrueandaccurateatthedateofpublication.Neitherthepublishernor the authors or the editors give a warranty, express or implied, with respect to the material containedhereinorforanyerrorsoromissionsthatmayhavebeenmade.Thepublisherremains neutralwithregardtojurisdictionalclaimsinpublishedmapsandinstitutionalaffiliations. ThisSpringerimprintispublishedbytheregisteredcompanySpringerNatureSwitzerlandAG Theregisteredcompanyaddressis:Gewerbestrasse11,6330Cham,Switzerland Preface The terms Evidence-Based Medicine (EBM) and Evidence-Based Surgery (EBS) are ubiquitous now. With very few exceptions, however, most sur- geonswhousethesetermsdonothaveagoodgraspofthemeaningofthese words. The editors of this book have the privilege of being associated with the institution (McMaster University) where the ideas and concepts of EBM and EBS originated. TheBritishMedicalJournalheraldedEBMasoneofthetop15advances in health care in the last 150 years [1]. We have been teaching and writing aboutEBSforoverthelasttwodecades.Inourinteractionswithsurgeonsof allspecialties,webelievethatthereisalackofunderstandingwhatEBSisall about and how it is applied in one’s clinical practice. Most surgeons, regardless of their specialty, have the surgical skills to perform an operation well. There is, however, a gap in understanding and interpretingwhat surgeons read inthe surgical literature. It isthe purpose of this book to fill this gap. Some surgeons may have perceived this gap already; others may not be aware of it. The sooner this gap is bridged the better for you as the surgeon at the individual level and the better for all us collectively as surgical specialties. Sincethelate1970s,wehavebeenwitnessingagradualparadigmshiftin the practice of medicine and surgery. The teaching of medicine and surgery by“authority”figureshasbeenlargelyreplacedbythescientificevidence.To paraphrasePincusandTugwell, eminence-basedsurgerycamouflagedinthe oratoricalskillsanddemeanorofseniorsurgeonswhohavebeenmakingthe same mistakes with increasing confidence over a number of years unchal- lenged has been supplanted by Evidence-Based Surgery [2]. At conferences, academic rounds, and journal clubs, we hear surgeons frequently quote this or that Randomized Controlled Trial (RCT) to support theirargumentfortheirclinicaldecisions.AlthoughitistruethattheRCTis considered the gold standard in examining the efficacy or effectiveness of somenovelsurgicalinterventionincomparisontostandardcare,themajority of our clinical decisions are based on designs other than RCT or meta-analysesofsuchstudies.Furthermore,evenifwefindanRCTthatmay seemrelevanttoourclinicalquestion,howdoweknowthattheconclusions of such study are credible? The term RCT in an article does not give it legitimacy unless it deserves it. v vi Preface The quality of evidence cannot be decided simply by the hierarchical categorization of the research by study design alone (meta-analysis, RCT, cohort studies, case-control studies, cases series). The reality is that not all publishedRCTsorsystematicreviewsoranyotherstudydesignsareofequal quality. In a series of articles published in Lancet since 2009, it has been estimated that 85% of what is spent on health research is wasteful. Some of the reasons given are as follows: poor study design, unclear reporting (sootherscannotinterpretthemorreplicatetheresearch),andfinallywhatis published cannot be applied to patients [3–5]. Thesurgicalliteratureisexpandingyearbyyear.PubMedalonehasadded between13,000and210,000surgery-relatedarticlesannuallysince2008[6]. More recently, we have seen asurge of not only legitimate surgical journals but also predatory ones [7]. While “legitimate” surgical journals have a supposedly, rigorous a peer-review process, this is currently haphazard. Not all reviewers have research methodology backgrounds and consequently, often, what we read is far from the truth and so, should not be implemented with patients. The purpose of this book specifically is to teach surgeons (academic or community),surgicalfellowsandsurgicalresidentsregardlessofthesurgical specialty, the skills to appraise what they read in the surgical literature. Surgeons need to be able to understand what they read before applying the conclusions of a surgical article to their practice. As most surgeons do not have the extra training in health research methodology, understanding how the research was done, how to interpret the results, and finally deciding to apply them to the patient level is indeed a difficult task. In aseriesof chaptersin this book, we explain themethodological issues pertaining to the various study designs reported in the surgical literature. In most chapters,we will startwith a clinical scenario with uncertaincourse of action with which most surgeons are struggling. The reader will be guided how to search the literature for the best evidence that will answer a surgical problem. Finding the evidence through a correct literature search is as essential as your scalpel at surgery. An identified article that seems relevant to the problem you are investi- gating will then be appraised by addressing three key questions: 1. Is the study I am reading valid? 2. What are the results of this study? 3. Can I apply these results to my patients? The ability to appraise a published surgical article effectively is as important as your surgical skill to complete the operation without harm. Evidence indicates that exposing surgical residents to health research methodology concepts increases research productivity and performance [8]. Preface vii Therefore, while the primary goal of this book is to teach surgeons how to appraise the surgical literature, a collateral benefit is that the concepts explained here may help research-minded surgeons produce better research. Hamilton, ON, Canada Achilles Thoma, MD, M.Sc., FRCSC Department of Surgery Division of Plastic Surgery Department of Health Research Methods Evidence and Impact McMaster University Hamilton, ON, Canada Sheila Sprague, Ph.D. Department of Surgery Division of Orthopaedic Surgery Department of Health Research Methods Evidence and Impact McMaster University Hamilton, ON, Canada Sophocles H. Voineskos, MD, M.Sc., FRCSC Department of Surgery Division of Plastic Surgery McMaster University Hamilton, ON, Canada Charles H. Goldsmith, Ph.D. Department of Health Research Methods EvidenceandImpact,McMasterUniversity Burnaby/Vancouver,BC,Canada FacultyofHealthSciences SimonFraserUniversity DepartmentofOccupationalScience andOccupationalTherapy FacultyofMedicine TheUniversityofBritishColumbia References 1. KamerowD,editor.Milestones,tombstonesandsexeducation.BMJ.2007;334:0–a. 2. Pincus T, Tugwell P. Shouldn’t Standard Rheumatology Clinical Care be Evidence-BasedRatherThanEminence-Based,Eloquence-Based,orEleganceBased? JRheumatol.2007;34:1–4. 3. Glasziou P, Chalmers I. Is 85% of health research really “wasted”? [Internet]: 2016. Available from https://blogs.bmj.com/bmj/2016/01/14/paul-glasziou-and-iain- chalmers-is-85-of-health-research-really-wasted/.Accessedby16July2018. 4. ChalmersI,GlasziouP.Avoidablewasteintheproductionandreportingofresearch evidence.Lancet.2009;374(9683):86–9. 5. Glasziou P,Altman DG, Bossuyt P,Boutron I, ClarkeM, Julious S, etal. Reducing waste from incomplete or unusablereports ofbiomedicalresearch. Lancet. 2014;383 (9913):267–76. viii Preface 6. CorlanAD.Medlinetrend:automatedyearlystatisticsofPubMedresultsforanyquery [Internet]; 2004. Available from http://www.webcitation.org/65RkD48SV. Accessed by16July2018. 7. Rohrich R, Weinstein A. Predator-in-Chief: Wolves in Editors’ Clothing. PRS Go. 2018;6:2-pe1652. 8. FarrokhyarF,AminN,DathD,BhandariM,KellyS.ImpactoftheSurgicalResearch MethodologyProgramonsurgicalresidents’researchprofiles.JSurgEduc.2014;71: 513–20. Contents 1 History of Evidence-Based Surgery (EBS)... .... ..... .... 1 Achilles Thoma, Jessica Murphy, Sheila Sprague and Charles H. Goldsmith 2 The Steps of Practicing Evidence-Based Surgery (EBS). .... 9 Achilles Thoma, Sheila Sprague, Luis H. Braga and Sophocles H. Voineskos 3 DevelopingaSurgicalClinicalResearchQuestion:ToFind the Answer in Literature Search or in Pursuing Clinical Research. .... .... ..... .... .... .... .... .... ..... .... 17 Achilles Thoma, Sheila Sprague, Sophocles H. Voineskos and Jessica Murphy 4 Finding the Evidence Through Searching the Literature.... 23 Laura Banfield, Jo-Anne Petropoulos and Neera Bhatnagar 5 Hierarchy of Evidence in Surgical Research. .... ..... .... 37 Gina Del Fabbro, Sofia Bzovsky, Achilles Thoma and Sheila Sprague 6 Evaluating Surgical Interventions . .... .... .... ..... .... 51 Aristithes G. Doumouras and Dennis Hong 7 A Primer on Outcome Measures for Surgical Interventions . .... ..... .... .... .... .... .... ..... .... 61 Joy MacDermid 8 Patient-Important Outcome Measures in Surgical Care. .... 71 Katherine B. Santosa, Anne Klassen and Andrea L. Pusic 9 Surrogate Endpoints .... .... .... .... .... .... ..... .... 85 Seper Ekhtiari, Ryan P. Coughlin, Nicole Simunovic and Olufemi R. Ayeni 10 How to Assess an Article that Deals with Health-Related Quality of Life.... ..... .... .... .... .... .... ..... .... 93 Achilles Thoma, Jenny Santos, Margherita Cadeddu, Eric K. Duku and Charles H. Goldsmith ix x Contents 11 Randomized Controlled Trial Comparing Surgical Interventions . .... ..... .... .... .... .... .... ..... .... 103 Max Solow, Raman Mundi, Vickas Khanna and Mohit Bhandari 12 How to Assess a Pilot Trial in Surgery . .... .... ..... .... 115 Guowei Li, Gillian A. Lancaster and Lehana Thabane 13 Non-inferiority Randomized Controlled Trials ... ..... .... 125 Yaad Shergill, Atefeh Noori, Ngai Chow and Jason W. Busse 14 Expertise-Based Randomized Controlled Trials .. ..... .... 135 Daniel Waltho, Kristen Davidge and Cagla Eskicioglu and for the Evidence-Based Surgery Working Group 15 The Surgeon’s Guide to Systematic Review and Meta-Analysis. ..... .... .... .... .... .... ..... .... 145 Andrea Copeland, Lucas Gallo and Noor Alolabi 16 Prospective and Retrospective Cohort Studies.... ..... .... 159 Ramy Behman, Lev Bubis and Paul Karanicolas 17 Case-Control Studies.... .... .... .... .... .... ..... .... 171 Achilles Thoma, Jenny Santos, Jessica Murphy, Eric K. Duku and Charles H. Goldsmith 18 Evaluating Case Series in Surgery. .... .... .... ..... .... 183 Christopher J. Coroneos and Brian Hyosuk Chin 19 Quality Improvement and Patient Safety in Surgery ... .... 193 Martin A. Koyle and Jessica H. Hannick 20 Diagnostic Studies in Surgery. .... .... .... .... ..... .... 201 Stuart Archibald, Jessica Murphy, Achilles Thoma and Charles H. Goldsmith 21 How to Assess a Prognostic Study . .... .... .... ..... .... 217 Saurabh Gupta, Kevin Kim, Emilie Belley-Côté and Richard P. Whitlock 22 Decision Analysis and Surgery.... .... .... .... ..... .... 225 Gloria M. Rockwell and Jessica Murphy 23 Economic Evaluations in Surgery.. .... .... .... ..... .... 239 Achilles Thoma, Feng Xie, Jenny Santos and Charles H. Goldsmith 24 Studies Reporting Harm in Surgery.... .... .... ..... .... 255 Robin McLeod 25 Evaluating Surveys and Questionnaires in Surgical Research. .... .... ..... .... .... .... .... .... ..... .... 265 Brian Hyosuk Chin and Christopher J. Coroneos 26 Opinion Pieces in Surgery.... .... .... .... .... ..... .... 277 M. Torchia, D. Austin and I. L. Gitajn
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