Arthroscopy Journal Systematic Review/Meta Analysis Template

Transcription

1 Arthrscpy Jurnal Systematic Review/Meta Analysis Template GENERAL Wrd cunt: 4,500 (excluding title page, blind title page, references, figure legends) Abstract wrd cunt: 300 Figure cunt: 7 (15 ttal figure parts) Table cunt: 4 Any new systematic review r meta analysis shuld ensure that the new prpsed manuscript has nt already been dne in the recent past (within five years) if s, why is a new ne needed? New evidence that will change cnclusin is a requirement. See Harris JD, et al Arthrscpy 2017 Aug;33(8): fr mre infrmatin n the pearls and pitfalls f meta analyses and systematic reviews. TITLE Cncise, precise Shuld be attentin getting, cntrversial Shuld say.: A Systematic Review r.: A Meta Analysis r.: A Systematic Review and Meta Analysis in the title Watch abbreviatins spell ut, ensure clarity N industry names ABSTRACT Shuld be able t stand alne any authr/reviewer/editr shuld be able t read the abstract and btain ALL the relevant infrmatin abut study design, cnduct, findings, cnclusins Abstract plays three rles (Ibrahim AM, Dimick JB; Writing fr Impact: Hw t prepare a jurnal article; 2017): When writing Imprves yur research questin, manuscript writing Once submitted Cnvinces editrs it s wrthy f 1) peer review, 2) publishing Half f manuscripts at high impact jurnals are rejected based n abstract alne After publicatin Getting the rest f the article read Readers start at the abstract and decide if rest f article wrth reading Abstract PEARLS: Far t many authrs chse a title and abstract just befre submissin, with little thught put int either. Unfrtunately, these are the first (and frequently, the nly) parts f the paper that will be read

2 PURPOSE Shuld verbatim match the purpse in the manuscript bdy s Intrductin. N backgrund, n intrductin, n hypthesis Shuld be specific, precise Shuld be an answerable questin (yes, n, discrete number, better, wrse, etc.) Shuld include (paraphrased): t perfrm a systematic review t determine. Or t perfrm a meta analysis t determine. METHODS Shuld use PRISMA guidelines (Preferred Reprting Items fr Systematic reviews and Meta Analyses) statement.rg/ Shuld register via PROSPERO (internatinal prspective registry f systematic reviews) Shuld reprt specific inclusin and exclusin criteria Shuld reprt the databases used (tw r mre) Shuld utilize methdlgical quality and bias assessment tl (CLEAR NPT, Cleman, Mdified Cleman, CONSORT, Pedr, Cchrane, Delphi, Detsky, Dwns and Black, Jadad, Level f evidence, MINORS, Newcastle Ottawa, QUADAS, Quality Appraisal Tl, STARD, Strbe, AMSTAR, R AMSTAR, etc.) Shuld utilize a recmmendatin tl (GRADE, SORT) Assess hetergeneity fr MA N cmmercial / prprietary names (unless exceptinal reasn) Statistical analysis, including brief meta analysis methds (including if cmputerized review manager used) RESULTS Shuld reprt a brief summary f studies analyzed Number f studies (and methdlgical quality scre[s]) Reprt hetergeneity Number f subjects (sex distributin, age) Number f interventins/surgeries (side distributin R/L; dminant/nndminant Directly answer the primary purpse(s) Shuld utilize specific p values (e.g. p=0.03, p=0.43, etc.), nt < r > (nly exceptin p<0.001) If individual level (e.g. subjects, patients) data able t be pled, a cmparisn t measures f clinical relevance (e.g. MCID [minimal clinically imprtant difference], PASS [patient acceptable symptm state], SCB [substantial clinical benefit]) shuld be reprted CONCLUSIONS Shuld verbatim match the cnclusins in the manuscript bdy s cnclusins Narrw, specific, supprted by the data/results/findings Only reprt significant findings in a MA LEVEL OF EVIDENCE Equates t the lwest level f evidence f included studies (e.g. if a systematic review as 10 studies and nine are level I, but ne is level IV, then the systematic review is level IV). Meta analyses shuld nly be perfrmed with level I (preferred) r II evidence studies with relatively hmgeneus participants, interventins, grups, and utcmes

3 CLINICAL RELEVANCE One t tw sentences Fr nn clinical studies (e.g. bimechanical, animal mdel) Fr clinical studies that d nt fit study type (i.e. therapeutic, diagnstic, prgnstic, ecnmic) INTRODUCTION Cncise summary f literature with apprpriate references Shuld give the authr/reviewer/editr cntext and a reasn t care abut the tpic, why it is imprtant Shuld create a knwledge gap, making it clear t the authr/reviewer/editr what is knwn and unknwn Shuld state hw the current investigatin will address the knwledge gap with a specific purpse(s) and hypthesis(es) Purpse Secnd t last sentence. Shuld verbatim match the purpse in the abstract Shuld be as specific as pssible and address the primary utcme measure Hypthesis Last sentence Specific, matches the purpse (shuld either be supprted r rejected in the cnclusin) Must be tested by the Methds METHODS Shuld be able t stand alne telling the authr/reviewer/editr exactly and transparently everything yu did. PRISMA guidelines shuld be fllwed fr every systematic review and/r meta analysis A PRISMA checklist shuld als be prvided (shws page number f all 27 items) A PRISMA flwchart shuld be generated (Figure) that shws applicatin f exclusin criteria t eligible studies PROSPERO registratin shuld be perfrmed. Reviews that have prgressed beynd pint f cmpleting data extractin at time f registratin are nt eligible fr inclusin in PROSPERO. Stages f registratin include (in rder f cmpletin): Preliminary searches Pilting f study selectin prcess Frmal screening f search results against eligibility criteria Data extractin Risk f bias (quality) assessment Data analysis Clear, specific inclusin and exclusin criteria Shuld fllw PICOS (participants, interventins, cmparatrs, utcmes, study design) in rder t ptimize inclusin and exclusin criteria If analyze therapeutic studies, shuld retain high quality studies (randmized, prspective, greater than 80% fllw up, greater than tw years fllw up, cmparative [versus gld standard interventin(s)]) If level I and II and hmgeneus participants and interventins, then metaanalysis can be perfrmed. D nt perfrm meta analysis n level III and IV data*

4 * in sme cases, a meta analysis f level III and IV may be warranted (examining rare utcmes r interventins that dn t lend themselves t randmizatin). Cnsult Cchrane Handbk f Systematic Reviews fr further guidance n inclusin f nnrandmized studies. If analyze diagnstic studies, shuld retain high quality studies (cnsistently applied reference gld standard cmparisn) If analyze prgnstic studies, shuld retain high quality studies (inceptin chrt studies) If analyze ecnmic studies, shuld retain high quality studies (cmputerized simulatins Mnte Carl, Markv derived frm level I studies) See CEBM (Center fr Evidence Based Medicine) new Level f evidence classificatins levels f evidence/ Shuld accunt fr duplicate study ppulatins in different studies Chse: higher level f evidence, greater number f subjects, clearer descriptin f methds and results, lnger duratin fllw up Shuld use tw r mre databases If use MEDLINE, Embase, and Cchrane Central Register f Cntrlled Trials will generate a recall rate f ver 97% in identificatin f all relevant studies in rthpedic surgery meta analyses MEDLINE, Embase, Cchrane, Scpus, PEDr, SprtDiscus, CINAHL, Web f Science, Science Direct, and Clinical Key are just a few cmmn nes used in arthrscpic and related surgery Exact search algrithm strategy shuld be prvided (transparency) Shuld use tw r mre reviewers in study identificatin, screening, eligibility, and inclusin (PRISMA flwchart) Shuld utilize at least ne apprpriate methdlgical quality scre r recmmendatin scre: EQUATOR Netwrk (Enhancing the QUAlity and Transparency Of health Research) umbrella rganizatin fr guidelines, peer reviewed articles, funding resurces, and ther entities cllabrating t imprve research quality AGREE Appraisal f Guidelines REsearch & Evaluatin fr clinical practice guidelines ARRIVE Animal Research: Reprting f In Viv Experiments CARE CAse REprt guidelines fr cmpleteness, transparency, and data analysis in case reprts CHEERS Cnslidated Health Ecnmic Evaluatin Reprting Standards CLEAR NPT CheckList t Evaluate A Reprt f a Nn Pharmaclgic Trial Cchrane Quality Assessment Tl fr randmized trials Cleman/Mdified Cleman fr randmized and nn randmized rthpedic trials CONSORT CONslidated Standards f Reprting Trials fr parallel grup randmized cntrlled trials COREQ COnslidated criteria fr REprting Qualitative research 32 item checklist fr interviews and fcus grups Delphi 8 item quality assessment tl fr randmized and nn randmized trials Detsky 14 item quality assessment tl fr randmized and nn randmized trials Dwns and Black 27 item quality assessment tl fr randmized and nnrandmized trials

5 GRADE Grading f Recmmendatins, Assessment, Develpment, and Evaluatin Jadad simple three questin (randmizatin, blinding, withdrawals) scale (nt recmmended) Level f evidence I V based n Center fr Evidence Based Medicine (CEBM) MECIR Methdlgical Expectatins f Cchrane Interventin Reviews MINORS Methdlgical Index fr NOn Randmized Studies Newcastle Ottawa quality assessment f nn randmized studies t be used in systematic reviews PRISMA Preferred Reprting Items fr Systematic reviews and Meta Analyses QUADAS QUality Assessment f Diagnstic Accuracy Studies Quality Appraisal Tl percentile quality rating fr nn randmized trials R AMSTAR/AMSTAR Revised Assessment f Multiple Systematic Reviews SORT Strength Of Recmmendatin Taxnmy SPIRIT Standard Prtcl Items: Recmmendatins fr Interventinal Trials SQUIRE Standards fr QUality Imprvement Reprting Excellence SRQR Standards f Reprting Qualitative Research STARD STAndards fr Reprting Diagnstic accuracy studies STROBE STrengthening the Reprting f OBservatinal studies in Epidemilgy Shuld include an assessment f risk f bias Cchrane s Risk f Bias tl fr randmized studies. ROBINS I tl (Risk f Bias in Nn randmized Studies f Interventins) Shuld use tw independent raters and include a descriptin f hw disagreements were reslved fr bth methdlgical quality and risk f bias. Reliability statistics (kappa, ICC, etc.) shuld be calculated t quantify the degree f agreement between the raters. Shuld assess bias qualitatively Selectin, detectin, perfrmance, transfer, nn respnder, publicatin, study design If a meta analysis is perfrmed the ratinale fr pling data shuld be described. Shuld address statistical analysis cmpletely with all relevant details if meta analysis, then statistician shuld be invlved; if systematic review, then best evidence synthesis shuld be perfrmed. Shuld include cmparisn f statistically significant findings t that f clinical imprtance/relevance: MCID, PASS, SCB it is critical t ensure that these cncepts are used fr within individual change, nt grup level, ppulatin level changes bserved with means f grups. See Harris JD, et al Arthrscpy 2017 Jun;33(6): fr a cmplete descriptin f cncept. If meta analysis, shuld apprpriately describe methds used: fixed effect versus randmeffects Fixed effect: based n the assumptin that single cmmn ( fixed ) effect underlies each study included. Under this assumptin, all studies are estimating the same cmmn effect. The nly reasn the included studies have different results is due t randm errr (chance, sampling variatin). Requires included studies t be hmgeneus bth clinically and methdlgically Larger, less variable studies receive mre weight than smaller, mre variable studies Interpretatin: The summary estimate represents best estimate f effect

6 Randm effects: allws fr differences in treatment effect frm study t study. Recgnizes that bth randm errr and differences between the study are respnsible fr why the included studies have different results. When there are clinical and methdlgical differences amng the included studies, nly accunting fr randm errr (fixed effect analysis) is nt sufficient. Randm effects incrprates these differences int the summary estimate. Interpretatin: The summary estimate represents an average f different effects. Imprtant distinctin frm a fixed effect analysis where a single cmmn effect is assumed acrss all studies. The utility f a randm effects summary estimate depends n hw well the differences between studies are identified and explred (see belw). Hetergeneity shuld be assessed statistically with the I 2 statistic as well as clinically thrugh evaluatin f the studies (statistical hetergeneity may be absent despite a clinically hetergeneus grup f studies). Hetergeneity shuld be explred. Statistical appraches include sub grup analyses r meta regressin Especially imprtant with randm effects analysis as the summary estimate represents an average f different effects. Identifying cntributrs t hetergeneity helps understand what clinical and methdlgical factrs may be respnsible fr the different effects and hw thse effects change when studies are sub gruped r further explred in regressin. Predictin intervals shuld be reprted fr a meta analysis using randm effects. Predictin intervals incrprate bth randm errr and hetergeneity t prvide a range f pssible effects. Shuld generate frest plt t graphically display whether individual (and weighted mean) studies favr treatment r cntrl grups Shuld generate funnel plt a scatterplt that demnstrates systematic hetergeneity as a means t graphically illustrate publicatin bias RESULTS Shuld be able t stand alne telling the authr/reviewer/editr exactly and transparently everything yu fund in essence, match the Methds sectin. Shuld cmpletely describe all relevant demgraphics: Study number f studies, quality scres, gegraphy, cnflict f interest Participants number f subjects, age, gender, side, bdy part, length f fllw up Interventins nn surgical, surgical, rehabilitatin Outcmes subjective patient reprted, bjective clinician measured, cmplicatins Shuld directly answer the primary (and secndary/tertiary) utcme(s) Avid redundancy between text and tables/figures If subjective qualitative analysis (best evidence synthesis) perfrmed, is the interpretatin unbiased? DISCUSSION First paragraph shuld briefly summarize the principal findings f the study and whether hypthesis(es) were cnfirmed r rejected. Shuld nt just re state the results.

7 Shuld cmpare and cntrast results f the current systematic review r meta analysis with that f any ther similar (r same) systematic reviews r meta analyses. Shuld discuss statistical significance versus clinical relevance fr statistically significant results LIMITATIONS Shuld be final paragraph f Discussin All types f bias shuld be addressed and discussed CONCLUSIONS Shuld verbatim match that f the Cnclusins sectin in the Abstract. Specific, narrw, based nly n actual results/findings/data/utcmes, withut speculatin, verstatement, r pinin REFERENCES Shuld be up t date, mst within the past five years Fllw PubMed jurnal abbreviatins Shuld be numbered cnsecutively in the rder in which they appear in the text FIGURES, TABLES Excellent way t efficiently summarize results Legends must define all abbreviatins Shuld be able t stand alne, s that the authr/reviewer/editr can understand everything relevant t the figure/table with a single take hme educatinal message Shuld always mentin patient psitin, viewing perspective (prtal), side, imaging rientatin Versin 1 fr Authrs/Reviewers/Editrs July 2018