Principles of Scientific Writing for an International Audience
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Principles of Scientific Writing for an International Audience Presentation Transcript

  • 1. Successful(Scien+fic(Wri+ng( Eugene(Elbert,(MS((Johns(Hopkins(( University,(U.S.)( Special(thanks(to(:(Paul(Siegel(MD,(MPH( 9F10(August(2012(
  • 2. Biological(Threat(Reduc+on(Program(( of(the( Defense(Threat(Reduc+on(Agency( (DTRA)( ( 2(
  • 3. Biological(Threat(Reduc+on(Program((•  Consolidate(especially(dangerous(pathogens( (EDPs)(into(one(or(two(safe,(secure(central( reference(laboratories(or(repositories(•  Build(and(sustain(longFterm(partnerships(through( interna+onal(scien+fic(engagement(and( coopera+on(•  Improve(capacity(to(detect,(diagnose(and(report( outbreaks(and(poten+al(pandemics(by(providing( training(to(personnel(of(the(appropriate(facili+es( 3(
  • 4. Biological(Threat(Reduc+on(Program((BTRP)( •  EDPs(for(human(and(animal(health(include:( o  Avian(and(pandemic(influenza((influenza(viruses)( o  CrimeanFCongo(Hemorrhagic(Fever((CCHF(virus)( o  Anthrax((Bacillus(anthracis)( o  Brucella((Brucella(species)( o  Tularemia((Francisella(tularensis)( o  Botulism((Clostridium(botulinum)( o  Tick(Borne(Encephali+s((TBE(virus)( o  Plague((Yersinia(pes6s)( o  Foot(and(Mouth(Disease((FMD)( o  Glanders( o  Newcastle(Disease(Virus( o  Rinderpest( o  Pox(viruses((goat(and(sheep(pox)( o  Swine(fevers((African(and(Classical(Swine(Fever)( •  Although( the( BTRPFprovided( training( focus( on( these( pathogens,( the(knowledge(and(skills(learned(and(prac+ced(are(applicable(to(a( broad( range( of( other( infec+ous( diseases( and( public( and( animal( health(concerns( ( ( 4(
  • 5. BTRPFProvided(Training(Courses(include:(( •  Disease(recogni+on;(( •  Laboratory(equipment(use(and(maintenance;(( •  Biosafety(and(security;(( •  Laboratory(safety;(( •  Laboratory(quality(systems;(( •  Respiratory(protec+on(program;(( •  Purchasing(and(inventory(control;(( •  Introduc+on(to(microbiology;(( •  Introduc+on(to(molecular(biology;(( •  Introduc+on(to(immunology/serology;(( •  Diagnos+c(assays(for(specific(EDPs;(( •  Laboratory(management;(( •  Sample(collec+on(and(processing;(( •  Basics(of(epidemiology;(and(others( 6(
  • 6. BTRP(Summary(•  Enhancement(of(exis+ng(surveillance(capacity( through(expansion(of(generic(skills(•  Development(of(capacity(for(rapid(detec+on((PCR( and(ELISA),(which(contributes(to(public(health(•  Improved(biosafety(and(biosecurity(for( laboratory(personnel(•  BTRPFprovided(training(complements(the( Ministry(training(requirements(for(specialists( 8((
  • 7. Successful(Scien+fic(Wri+ng( 9(
  • 8. Introduc+on(Objec+ves(of(the(workshop:((•  To((introduce(basic(concepts(of(scien+fic(approach(•  To(detail(the(structure(and(format(of(scien+fic(papers.(•  To(compare(examples(of(different(research(designs.(•  To(examine(components(of(a(scien+fic(paper.(•  To(cri+cally(examine(published(examples(of(scien+fic( wri+ng.(•  To(apply(new(wri+ng(skills(to(draging(an(abstract.(•  To(learn(about(the(submission(process(for(publica+ons,( funding(proposals,(and(presenta+ons( 10(
  • 9. Why(do(we(publish?(•  Presen+ng(research(•  Reaching(global(scien+fic(community(•  Advancing(science(•  Educa+on(•  Funding(and(credibility(( 11(
  • 10. 12(
  • 11. Repor+ng(Scien+fic(Research(•  Hypothesis(or(research(ques+on(•  Planned(research(•  Ethics(( –  Plagiarism( –  Misuse(of(data(and(informa+on( –  Conflict(of(interest( –  Integrity( –  Human(subject(research((( 13(
  • 12. Process(of(scien6fic(wri6ng( Submiing( Hypothesis( Wri+ng(( Study(plan( ar+cle(Having(( Experiment(journal,(audience((in(mind( Results( Data(processing( genera+on( 14(
  • 13. General(Guidelines(for(Scien+fic( Papers:(Style(and(Content(EASE(guidelines(•  Complete,(concise(and(clear(•  For(effec+veness(of(interna+onal( coopera+on(all(publica+ons(should(be:(•  COMPLETE,(CONCISE(AND( CLEAR!(•  IMPORTANT(( 15(
  • 14. General(Guidelines(for(Scien+fic( Papers:(Style(and(Content(•  Do(not(include(irrelevant(informa+on(•  Informa+on(should(not(be(repeated(•  Include(only(necessary(tables(and(figures(•  Cap+ons(–(informa+ve(but(concise(•  Delete(redundancies(•  Define(abbrevia+on(at(first(use(•  Do(not(overFgeneralize(•  Numbers(for(all(numerals( 16(
  • 15. Content(•  Study(should(be(planned(in(advance(•  The(journal(and(the(audience(should(be( chosen(•  Informa+on(should(be(organized(•  All(the(components(of(scien+fic(ar+cle( should(be(present(and(sa+sfy(the( guidelines(for(a(chosen(journal( 17(
  • 16. Repor+ng(Guidelines:(Content(•  Dis+nguish(your(original(ideas(•  Paraphrase(text(from(other(sources(•  Proper(terms((plant(community(vs.(phytocoenosis)(•  Define(every(uncommon(term((•  Avoid(ambiguity(•  Be(clear(what(you(regard(as(100%(when(repor+ng(%(•  SI(units((interna+onal(system(of(units;(metric)(•  Decimal(point((•  Remember(that(the(text(will(be(read(by(foreigners( 18(
  • 17. Repor+ng(Guidelines:(Content(•  Make(posi+ve,(objec+ve(asser+ons,(directly(supported(by(the( results,((with(necessary(qualifica+ons(and(caveats(•  Don’t(oversell:((“This(result(clearly(proves(that(the(neural( network(approach(is(superior(and(will(revolu+onize(research( methods”.(•  Don’t(base(substan+al(claims(on(unpublished(data(or(on( “experience”(without(objec+ve(suppor+ng(evidence.((((•  If(you(rely(on(a(reference(to(draw(a(conclusion,(be(sure(the( reference(supports(the(idea,(and(say(where(the(support(may( be(found(in(the(reference.( 19(
  • 18. A(Dic+onary(of(Useful(Research(Phrases((•  "It(has(long(been(known..."( ( •  I(didnt(look(up(the(original(•  "It(is(believed(that..."( references(•  "It(is(generally(believed( •  I(think( that..."( •  My(friends(think(so,(too(•  "A(sta+s+cally(oriented( ( projec+on..."( •  Wild(guess(•  “Typical(results(are(shown”( •  Best(results(are(shown(•  “Obviously,(we(will(need( •  I(don’t(understand(anything( addi+onal(studies”( (•  “Authors(thanks(Joe(in( •  Joe(did(the(work(and( conduc+ng(experiment(and( George(explained(it(to(me( George(for(helpful( ( comments”( 20(
  • 19. Example(“In( order( to( provide( analy+c( control( during( forensicFchemical( inves+ga+on,( it( is( customary( to( use( highly(sensi+ve(and(specific(analysis(methods.(Very(popular(in( the( prac+ce( of( chemicFtoxic( studies( is( the( TLC(method(in(view(of(its(accessibility,(ease(of(conduc+ng(and(expressiveness.(Due(to(the(possibility(of(changing(not( only( sorbents( but( also( solvents,( it( is( possible( to(quickly(solve(the(problems(of(separa+on”( 21(
  • 20. Repor+ng(Guidelines:(Text(Structure(•  Simple(sentences,(should(not(be(very(long(•  Avoid(passive(voice(•  Text(should(be(cohesive,(logically(organized(•  Each(paragraph(should(start(with(a(topic(sentence(•  Use(text(tables(•  Make(figures(and(tables(understandable(by(themselves(•  Explain(your(figures(and(charts,(and(jus+fy(their( inclusion.((Do(not(just(show(them(with(no(stated( reason.( 22(
  • 21. Text(tables(Original(sentence:(•  Iron(concentra+on(means((±standard(devia+on)(were(as( follows:(11.2±0.3(mg/dm3(in(sample(A,(12.3±0.2(mg/ dm3(in(sample(B,(and(11.4±0.9(mg/dm3(in(sample(C.(Modified:( •  Iron(concentra+on(means((±standard(devia+on,(in( mg/dm3)(were(as(follows:( •  sample(B((12.3±0.2( •  sample(C((11.4±0.9( •  sample(A((11.2±0.3( 23(
  • 22. Replace(phrases(with(a(single(word(•  Considering(this(fact(•  In(the(rela+on(to((•  Exceeding(number(•  In(the(previous(case(•  In(the(absence(•  In(large(number(of(cases( 24(
  • 23. Passive(Voice(“Have(you(ever(been(told(to(use(passive(voice”( ( ( ( (or(“Did(anyone(tell(you(to(use(passive(voice”(Examples:*•  “James(Watson(was(awarded(the(Nobel(Prize(for( discovering(the(molecular(structure(of(DNA.“(vs.(•  "The(Nobel(CommiSee(awarded(James(Watson( the(Nobel(Prize(for(discovering(the(molecular( structure(of(DNA."( 25(
  • 24. Passive(voice(Nobody(takes(responsibility(in(passive(voice:((“Mistakes(were(made(during(the(experiment”(vs.(We(made(mistakes(during(the(experiment((“It(is(shown(in(the(table”(vs.*The(table(shows((( 26(
  • 25. Example(Common(dysfunc+on(of(the(immune(system(was$shown$in(the(trials(on(humans(and(animals(__________________________________(Trials(on(humans(and(animals(show(a(common(dysfunc+on(of(the(immune(system( 27(
  • 26. Correct(Use(of(Passive(Voice(•  When(the(ac+on(is(more(important(than(the( agent(of(it((as(in(Materials(and(Methods)((•  In(order(to(emphasize(somebody(other(than( the(ac+ng((agent((•  When(the(agent(is(unknown( 28(
  • 27. Repor+ng(Guidelines:(Language(•  Use(commonly(known(words,(but(not( idioma+c(expressions(•  Define(abbrevia+ons((avoid(them(in(abstract)(•  Spelling((•  Past(tense(in(body,(present(in(general( statements(•  Refer(to(the(author(as(“we”(or(“I”(not(“the( author”( 29(
  • 28. Repor+ng(Guidelines:(Language(Transforma2on*of*verbs*into*nouns*(Obtained(es+mates(–(es+mated(Gained(improvementF(improved(Showed(growth(–(grew(Made(a(decision(–(decided((( 30(
  • 29. Common(Fallacies(in(Wri+ng ((•  Non$Causa$Pro$Causa*Fallacies*—*No*Cause* for*Cause*•  Asempts(to(establish(a(causal(rela+onship( –  Cum(Hoc,(Ergo(Propter(Hoc(( –  Post(Hoc,(Ergo(Propter(Hoc(( –  The(Regression(Fallacy(( –  Texas(Sharpshooter(Fallacy( 31(
  • 30. Fallacies(in(Wri+ng( $Cum$Hoc,$Ergo$Propter$Hoc*—*With*This,*Therefore*•  African(American(popula+on(is(more(likely(to(experience(metabolic( consequences(of(Chronic(Kidney(Disease((CKD)(before(reaching(the( eGFR(<60(ml/min(threshold(…(that(these(observa+ons(support(a( need(to(adapt(clinical(prac+ce(guidelines(shiging(screening(for(CKD( to(a(higher(eGFR(threshold(specifically(for(African(Americans((1)((•  The(assump6on(that(the(measured(clinical(parameters(in(this( representa6ve(popula6on(are(physiologically(linked(to(CKD(in( African(Americans(is(simplis6c(and(ignores(the(effects(of(a( combina6on(of(gene6c(and(physiologic(adapta6ons(superimposed( on(a(background(of(social(and(environmental(factors(that(account( for(minority(health(dispari6es((2)((•  Lesson:*Adjustment(for(possible(confounders(and(other(sources(of( bias(* 32(
  • 31. Fallacies(in(Wri+ng( $Post$Hoc,$Ergo$Propter$Hoc*—*AAer*This,* *Therefore* *Because*of*This**•  “Since(that(event(followed(this(one,(this(event(must( have(caused(that(one.”(It(also(is(referred(to(as(“false( cause”(or(“coincidental(correla+on.”(•  7(women(in(California(developed(ovarian(cysts(taking( the(new(mul+phasic(oral(contracep+ve(pills(which(led( to(case(series(report(and(media(prin+ng(the(story([1].((•  No(associa6on(was(shown(in(followYup(studies([2]((•  Lesson:*Checking(for(possible(confounders,(conduc+ng( valida+on(studies(before(jumping(to(conclusions,( repor+ng(on(it(in(wri+ng( 33(
  • 32. Fallacies(in(Wri+ng( *Texas*Sharpshooter*Fallacy*** Outbreak(foci?( ((•  In(medical(research,(this(fallacy(occurs(when(inves6gators(select( certain(data(to(demonstrate(a(causeYeffect(rela6onships.( 34(
  • 33. Fallacies(in(Wri+ng( *The*Art*of*Argumenta$ –  Argumentum$ad$Ignoratum*(Appeal*to*Ignorance):( Absence(of(evidence(is(not(evidence(of(absence( Width*of*Confidence*Interval(±w)* Sample*Size(n)* * 0.01( 9612( 0.02( 2403( 0.03( 1068( 0.05( 384( 0.10( 96( 0.15( 43( Sample*sizes*required*to*es2mate*a*true*prevalence*of*0.50*with*95%*confidence* intervals*of*different*widths*(±w)* (Lesson:*Making(sure(that(the(sample(size(is(large(enough.(Recognizing(beneficence(and(nonFmaleficence( 35(
  • 34. Fallacies(in(Wri+ng( $Argumentum$ad$Verecundiam*(Appeal*to*Authority):*Users(of(this(fallacy(ogen(call(upon(the(published(works(of(others(to(bolster(their(arguments,(without(ques+oning(the(accuracy,(reliability,(or(validity(of(those(sources(•  Quote(from(an(editor(as(a(condi+on(for(publica+on(highlights( the(problem:(“you(cite(Leukemia([once(in(42(references].( Consequently,(we(kindly(ask(you(to(add(references(of(ar6cles( published(in(Leukemia(to(your(present(ar6cle”((1)(•  Editors(incen+ve(to(inflate(impact(factors(through(selfF cita+on(•  Survey(found(that(having(a(tenure(posi6on(also(increased( coercion(•  Lesson:((Being(true(to(your(work( 36(
  • 35. Fallacies(in(Wri+ng( $Argumentum$ad$An;quitatem*(Appeal*to* *Tradi2on*or*History)((“(Talking(about(acupuncture)(I(think(it(is(insul+ng(to(say(that(Chinese(people(would(carry(on(with(some(sort(of(mys+cal(belief(when(it(didn’t(work”( “Well,(you(know(–(acupuncture(is(one(of(those(amazing( things.(I(mean(it(has(been(around((for(several(thousand( years(.(.(.(there(is(a(huge(amount(of(validity(to(what(it( represents,(( and(there(has(to(be(–(or(it(wouldn’t(have(survived(such(a(long( +me(“( ( Lesson:((Not(making(unsupported(claims( 37(
  • 36. Fallacies(in(wri+ng ((•  Argumentum$ad$Populum*(Appeal*to*the*People*or*Popularity)((•  4(from(5(den+sts(recommend(sugarF free(“Trident”“(chewingFgum!(•  The(adver+sement(“forgot”(to(men+on(“If(pa+ents(INSIST(to( use(chewingFgum”.(They(also(hid(each(5th(den+st( recommended(to(avoid(the(use(of(chewingFgum.(•  «Thus(based(on(the(assessment(of(leading(Russian(clinics( “Sangviri+n”(is(one(of(the(effec+ve(modern(an+microbial(drug( of(local(and(commonF(resorp+ve(ac+on(for(preven+on(and( treatment(of(different(infec+ous(diseases([14–17].»(7/28/2012(
  • 37. Fallacies(in(Wri+ng(Myths*of*Beneficence**An(analysis(of(60(adver+sements(that(had(appeared(in(the(Bri+sh(Medical(Journal(between(1999(and(2001(demonstrated(that(drug(adver+sing(uses(strong(imagery(to(fabricate(mythical(associa+ons(between(medical(condi+ons(and(branded(drugs,(and(that(drug(adver+sing(manipulates(readers’(percep+ons(by(subtle(appeal(to(ancient(and(modern(mythological(founda+ons(of(humanism(and(Western(psychology.(( 39(
  • 38. Fallacies(in(Wri+ng(False*Dichotomy((This(is(also(called(a(false(dilemma,(an(eitherYor(fallacy,(fallacy(of(false(choice,(or(blackYandYwhite(thinking.((Most(wideFspread(false(dichotomy(in(scien+fic(repor+ng:(((Sta+s+cal(significance(P(=(0.049(vs.(P(=(0.051(( 40(
  • 39. Fallacies(in(Wri+ng(Essen2alism((Some(argument(in(print(or(spoken(word,(some(“essen+al(feature”(is(proposed(as(a(defining(characteris+c(of(an(otherwise(complex(issue(or(larger(problem((Each(scien+fic(specialty(looks(at(disease(differently.(For(example,(cancer(from(the(perspec+ve(of(a(general(surgeon,(a(pathologist(or(an(acupuncturist(are(completely(different.(((Lesson:(To(be(aware(of(specialized(terminology(and(body(of(knowledge(when(repor+ng( 41(
  • 40. Fallacies(in(Wri+ng(Редукционизм$Efforts(to(simplify(the(problem(to(the(simple(rela+ons(((O’Connor(et(al.(2011):(“Reduc+onist(methods(of(disease(control(involve(the(removal(of(infec+on(or(the(infec+ous(agent,(implemen+ng(barriers(to(direct(and(indirect(transmission(or(by(increasing(inherent(or(acquired(immunity(to(the(infec+ous(agent.(However,(for(those(diseases(which(evade(such(methods(of(conven+onal(control,(a(more(comprehensive(understanding(of(the(complex(interac+ons(amongst(biological((agent(and(host(s)),(environmental,(economic(and(social(factors(which(can(affect(the(emergence(and(spread(of(an(infec+ous(disease(is(required.”( 42(
  • 41. Things(to(avoid:(•  Plagiarism((•  Fishing(expedi+ons(–(research(must(be(hypothesis(driven(•  Do(not(plan(your(study(in(order(to(use(your(results(to(pool( evidence(against(the(same(problem((e.g.(metaFanalyses.((•  Do(not(fail(to(take(into(account(heterogeneity,(uncertainty( and(dependence(•  Do(not(fail(to(have(a(robust(exploratory(data(analysis((EDA)( before(proceeding(into(any(confirmatory(tes+ng((John( Tukey(teachings)(•  Do(not(discount(the(importance(of(internal(and(external( validity(when(interpre+ng(results(•  Do(not(underes+mate(the(sta+s+cs.((The(absence(of( evidence(is(not(the(evidence(of(absence(–(your(study(may( not(have(enough(power(to(detect(anything(unless(you(have( large(numbers( 43(
  • 42. Things(that(annoy(reviewers(–  Poor(English(–  Repe++on(–  Lack(of(structure(in(the(text(–  Sentences(that(are(too(convoluted(and(long((–  Lack(of(asen+on(to(detail((a(premature(drag(with( typographical(errors,(etc.)(–  Not(well(thought(out(statements((make(each(word( count)(–  Obscure(methods(or(not(well(described(–  Oversta+ng(the(results(–  Too(long(of(a(paper( 44(
  • 43. Repor+ng(Guidelines:(Structure(•  IMRaD(standard((Introduc+on,(Methods,(Results,(and( Discussion)(•  Design(Specific(–(EQUATOR(network(•  Journal(Fspecific(•  General:( –  Title(Page( –  Conflict(of(Interest(No+fica+on(Page( –  Abstract( –  Introduc+on( –  Methods( –  Results(( –  Discussion( –  References( 45(
  • 44. Standardizing(Health(Repor+ng(EQUATOR((Enhancing(Quality(and(Transparency(of(Health( Research)(network:(“Too(oaen,(good(research(evidence(is(undermined(by(poor( quality(repor6ng”(•  Raising(awareness(of(the(crucial(importance(of(good( repor+ng(of(research((•  Becoming(the(recognized(global(center(providing(resources,( educa+on(and(training(rela+ng(to(the(repor+ng(of(health( research(and(use(of(repor+ng(guidelines(•  Assis+ng(in(the(development,(dissemina+on(and( implementa+on(of(repor+ng(guidelines(•  Monitoring(the(status(of(the(quality(of(repor+ng(across( health(research(literature(•  Conduc+ng(research(rela+ng(to(the(quality(of(repor+ng(( 46((
  • 45. Guidelines(for(Repor+ng(Common( Study(Types(•  CONSORT(–(Consolidate(Standards(of( Repor+ng(Trials(•  STROBE(–(Strengthening(the(Repor+ng(of( Observa+onal(studies(•  STARD(–(Standards(for(repor+ng(of(Diagnos+c( Accuracy(•  QUOROM(–(Quality(of(Repor+ng(of(MetaF analyses((under(CONSORT)( 47(
  • 46. Example(–(STROBE(checklist (( Item No RecommendationTitle and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract (b) Provide in the abstract an informative and balanced summary of what was done and what was foundIntroductionBackground/rationale 2 Explain the scientific background and rationale for the investigation being reportedObjectives 3 State specific objectives, including any prespecified hypothesesMethodsStudy design 4 Present key elements of study design early in the paperSetting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collectionParticipants 6 (a) Cohort study—Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up Case-control study—Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls Cross-sectional study—Give the eligibility criteria, and the sources and methods of selection of participants (b) Cohort study—For matched studies, give matching criteria and number of exposed and unexposed Case-control study—For matched studies, give matching criteria and the number of controls per case 48(
  • 47. Study(Designs(in(Public(Health(Experimental*(Interven2onal)*Studies* Observa2onal*Studies*Randomized(Trials( Case(reports(Community(Trials( Case(Series( Descrip+ve(Therapeu+c/Preven+ve(Trials( CrossFsec+onal(Studies( Surveillance( ( Cohort(Studies( ( Analy+c( CaseFControl( 49(
  • 48. Observa+onal(Descrip+ve(Studies(•  Case(Reports(–(detailed(presenta+ons(of(a( single(case(or(a(handful(of(cases.(( “Normal(Plasma(Cholesterol(in(an(88FYearFOld(Man(Who(Eats(25(Eggs(a( Day(—(Mechanisms(of(Adapta+on”([Kern(J,(NEJM(1991;(324:896–899](•  Case(Series(–survey(of(a(group(of(individuals( with(a(par+cular(disease(performed(at(a(single( point(of(+me.( “Pneumocy+s(pneumonia:(Los(Angeles”([MMWR(Morbidity(and( Mortality(Weekly(Report(1981;30:250Y252]((( 50(
  • 49. CrossFSec+onal(Studies(•  Describes(health(of(popula+ons((both(exposed( and(nonFexposed)(•  Iden+fies(prevalent(cases(•  Finds(associa+on,(not(causa+on((•  BestFsuited(for(lisle(disability,(preFsymptoma+c( studies(•  Surveys(•  Good(for(planning(health(care( –  Na+onal(Health(Surveys(are(a(good(example( 51(
  • 50. Surveillance(•  An(ongoing,(systema6c(collec6on,(analysis(and(interpreta6on(of( healthYrelated(data(essen6al(to(the(planning,(implementa6on,(and( evalua6on(of(public(health(prac6ce(•  Detec+on(and(no+fica+on(of(health(events(•  Collec+on(and(consolida+on(of(data(•  Inves+ga+on(of(cases(and(outbreaks(•  Rou+ne(Repor+ng((•  Feedback( U.S.(CDC:(Ears,(EWIDS,(NTSIP,(ESP,(NEDSS,(FluNet,(BRFSS,(FoodNet,(etc.( Australia:((NNDSS( U.S.:(ProMED,(HealthMap( Canada:(FluWatch,(GPHIN( France:(GPs(Sen+nelles(Network( Asia:(APEC(EINet( WHO:(GOARN( Europe:(MedlSys( 52(
  • 51. CaseFControl(Studies(•  Comparison(of(cases(versus(nonFcases( (controls)(•  Retrospec+ve(for(exposure(•  Matching(all(popula+on(characteris+cs(of( cases(to(those(of(controls((including(biases)(•  Mostly(for(prevalent(cases((but(could(be(for( incident(cases,(too)( 53(
  • 52. Cohort(Studies(•  To(support(the(rela+on(between(the(cause( and(disease(•  Presence(or(absence(of(risk(factor(is( determined(before(outcome(occurs(•  Longitudinal/prospec+ve/incidence(studies(•  Cohorts(are(free(of(disease(at(baseline(•  Cohorts(should(be(comparable(•  Diagnos+cs(and(eligibility(should(be(defined( 54(
  • 53. Cohort(vs.(CaseFControl( COHORT(STUDY(DATA(COLLECTION( Sick( Exposed( Sample(of( Not(Sick( diseaseFfree( individuals( Sick( Not( Exposed( Not(Sick( Exposed( Develop( Illness(Not(Exposed( Popula+on( Exposed( Don’t( Develop(Not(Exposed( Illness( CaseFControl(Data(Collec+on( 55(
  • 54. Experimental:(Control(Study((Controlled:( –  Inves+gator(decides(on(interven+on((Randomized:( –  Gold(Standard(in(Epidemiological(research( –  Controls(for(confounding( –  Prevents(selec+on(Bias(Therapeu+c(vs.(Preven+ve:(( (((((Pa+ents(with(Disease(vs.(Popula+on(at(Risk(( 56((
  • 55. Experimental:(Controlled(Studies( (DATA(COLLECTION( Exposure( COHORT((Observa+onal)( occurs( naturally( Sick( Exposed( Sample(of( Not(Sick(diseaseFfree( individuals( Sick( Not( Exposed( Not(Sick( Inves+gator( CONTROLLED((Interven+onal)( Determines( Exposure( 57(
  • 56. Randomized(Clinical(Trial(• (Sample(size(should(be(sufficient(• (Possibility(to(follow(up(during(the(trial(• (Par+cipants(should(be(informed(of(risks/(benefits/(blinding/(placebo(• (Inclusion(Criteria( Reference(Popula+on(( Reference(Popula+on(( Experimental( Experimental( Popula+on( Popula+on( ( ( Study( Popula+on( Internal(Validity( External(Validity( 58(
  • 57. Randomized(Clinical(Trial(•  Design( –  Simple( –  CrossFover,(factorial((•  Sampling(•  Eligibility(criteria(•  Blinding:(single(vs.(double(•  Alloca+on:(Randomiza+on(•  FollowFup(•  Analysis(•  Therapeu+c(vs.(NonFtherapeu+c( 59(
  • 58. Randomized(Trial:(CONSORT(Flow( Eligible(( NonFeligible( Declined( Alloca+on(using( randomiza+on( scheme( FollowFup( Included(in( analysis( 60(
  • 59. Protocol of clinical study (typical errors)•  During(development(of(CS(protocol:( –  Fail(to(jus+fy(the(study(of(given(drug(by(the(given(indica+ons;( –  Absence(of(preFclinical(and(clinical((if(applicable)(trials;( –  The(objec+ves(of(study(are(not(listed((primary(and(secondary( objec+ves),(hypothesis(of(study;( –  Mixed(concep+on(of(primary(objec+ve(of(study(and(criteria(of( efficacy;( –  Sta+s+cs!(Instead(of(sample(size(jus+fica+on(and(sta+s+cal(power:( “the(assessment(will(be(performed(with(PC,(Excel,(Student’s( methods,(etc.”;( –  Vague(procedures(and(methods,(allowing(ambiguous(interpreta+on;( –  No(dates,(no(versions(
  • 60. Protocol of clinical study (typical errors)•  While(repor+ng(of(CS:(( –  Vague(descrip+on(of(study(popula+on,(that(unable(the(formula+on(of( conclusion(about(homoscendacity;( ( –  No(sta+s+cal(assessment(inclusion/exclusion(criteria(of(lost(followFup( pa+ents;( ( –  No(side(therapy(details(and(its(effect(in(sta+s+cal(analysis;( ( –  No(severity(and(resolving(of(side(effects((e.g.(2(pa+ents(presented(the( head(ache(–(no(terms,(methods(od(treatment,(outcome,(etc.);( ( –  No(pa+ents’(compliance(data;( ( –  Separate(reports(from(each(center(instead(of(allFcenters(consolidated( report(…(
  • 61. General(Guidelines(For(Selec+on(of(Study(Type(Study*objec2ve( Study*type(Study(of(rare(diseases( Case(control(studies(Study(of(rare(exposure,(such(as(exposure(to( Cohort(studies(in(a(popula+on(group(in(industrial(chemicals( which(there(has(been(exposure((e.g.( industrial(workers)(Study(of(mul+ple(exposures,(such(as(the( Case(control(studies(combined(effect(of(oral(contracep+ves(and(smoking(on(myocardial(infarc+on(Study(of(mul+ple(end(points,(such(as( Cohort(studies(mortality(from(different(causes(Es+mate(of(the(incidence(rate(in(exposed( Exclusively(cohort(studies(popula+ons(Study(of(covariables(which(change(over( Preferably(cohort(studies(+me(Study(of(the(effect(of(interven+ons( Interven+on(studies( 63(
  • 62. Costs(of(different(types(of(bias(for(different(study(designs( Ecological* CrossZ CaseZ Cohort* study* sec2onal* control* study(and* study* study* RCT)* Selec+on( N/A( 2( 3( 1( bias( Recall(bias( N/A( 3( 3( 1( Loss(to( N/A( N/A( 1( 3( followFup( Confounding( 3( 2( 2( 1( Time( 1( 2( 2( 3( Required( Costs( 1( 2( 2( 3( 1Fslight;(2Fmoderate;(3Fhigh;(N/A=(not(applicable( 64(
  • 63. Introduc+on(sec+on( Purpose:(to(convince(the(reader(that(your(study(will( yield(knowledge(or(knowFhow(that(is(new(and(useful(•  Iden+fy(a(gap(in(knowledge(or(knowFhow((study( problem)( o  Provide(key(background((scope/nature/magnitude(of(the(gap)( o  Be(clear(that(filling(this(gap(will(be(useful.( o  Describe(the(relevant(limita+ons(of(previous(studies(•  Present(your(approach(to(filling(the(gap((study( purpose)( o  Be(clear(that(your(approach(is(new( o  Emphasize(that(your(approach(addresses(the(limita+ons(of( previous(studies(in(a(logical(and(compelling(way( Oaen(requires(just(three(paragraphs( 65(
  • 64. Introduc+on(Checklist(Background Statement: Scope nature magnitude of the gap Be clear that filling the gap is usefulProblem Statement Describe relevant limitationsStudy Statement Be clear that your approach is new Emphasize that your approach addresses limitationsSummary Statement Summarizes the study 66(
  • 65. Introduc+on(sec+on((•  No(major(difference(in(introduc+on(sec+on( between(study(types(•  Some+mes(summary(statement(is(omised,(or( becomes(part(of(the(study(statement(•  STROBE:(Introduc+onBackground/ra+onale 2 Explain(the(scien+fic(background(and(ra+onale(for( the(inves+ga+on(being(reportedObjec+ves 3 State(specific(objec+ves,(including(any(preFspecified( hypotheses 67(
  • 66. Introduc+on(sec+on(The(next(four(slides(detail(the(introduc+on(checklist(process(for(four(separate(studies:((•  Background(statement(•  Problem(statement(•  Study(statement( –  General(descrip+on(of(the(surveillance(system(•  Summary(statement( 68(
  • 67. Background* The(treatment(of(human(immunodeficiency(virus((HIV)(infec+on(has(undergone( Statement:* considerable(change.(Protease(inhibitors(and(non–nucleosideFanalogue(* reverseFtranscriptase(inhibitors,(when(used(as(part(of(combina+on(drug( regimens,(can(profoundly(suppress(viral(replica+on,(with(consequent(reple+on( of(CD4+(cell(counts.( Mul+ple(clinical(trials(have(shown(the(virologic(and(immunologic(efficacy(of(the( newer,(highly(ac+ve(an+retroviralFdrug(combina+ons(by(measuring(the(plasma( load(of(HIV(RNA(and(CD4+(cell(counts.(In(addi+on,(prophylac+c(medica+ons(are( now(being(used(rou+nely(to(prevent(disseminated(Mycobacterium(avium( complex(infec+on Problem* Several(reports(have(described(reduc+ons(in(mortality(and(in(the(rate(of( Statement* hospitaliza+on(of(HIV(infected(pa+ents;(however,(such(reduc+ons(have(not( ** been(clearly(related(to(specific(therapeu+c(regimens.(* Study*Statement* We(analyzed(data(collected(over(42(months(in(the(HIV(Outpa+ent(Study.(During( this(period,(rates(of(chemoprophylaxis(against(opportunis+c(infec+on(remained( rela+vely(constant(even(while(paserns(of(an+retroviral(therapy(were(changing Summary* This(report(outlines(the(changes(in(death(rates(and(the(incidence(of( Statement* opportunis+c(infec+ons(in(a(large(group(of(HIVFinfected(outpa+ents,(many(of( whom(had(previously(received(extensive(treatment. 69(
  • 68. Background* Among(the(few(diseases(claimed(to(occur(more(ogen(in(nonFsmokers(than( Statement:* smokers(1(2(that(of(greatest(poten+al(importance(is(Alzheimers(disease,(which(* accounts(for(most(of(the(demen+as(of(later(life(in(Britain Problem* The(published(epidemiological(evidence,(although(sugges+ve(of(an(inverse( Statement* rela+on(with(smoking,(is(not(conclusive(either(about(Alzheimers(disease(or( ** demen+a(in(general.(Much(of(the(evidence(derives(from(small(retrospec+ve(* studies(of(uncertain(reliability,(many(of(which(excluded(vascular(demen+a.( Prospec+ve(studies,(in(which(smoking(habits(are(recorded(before(the(onset(of( demen+a,(should(be(more(informa+ve(about(the(overall(effects(of(smoking,( par+cularly(if(they(concern(large(numbers(and(prolonged(follow(up.(Only(a(few( such(studies(have,(however,(been(properly(reported((none(of(which(had( prolonged(follow(up) Study* We(sought(evidence(from(the(cohort(of(Bri+sh(doctors(who(have(been( Statement* followed(since(1951,(with(their(smoking(habits(reviewed(every(six(to(12(years.3( 4(Many(have(died(from(or(with(some(type(of(demen+a(over(the(past(two( decades. Summary* Statement* 70(
  • 69. Background* Alcohol(was(first(implicated(as(a(possible(risk(factor(for(stroke(in(1725(1)( Statement:* Several(epidemiological(studies(now(suggest(a(UFshaped(associa+on(between(* alcohol(intake(and(stroke(2). Problem* Previous((studies(have(been(cri+cized(for(not(differen+a+ng(between( Statement* nondrinkers(who(were(lifelong(abstainers(and(those(who(had(given(up( ** drinking(3F7)(* By(asking(specifically(about(previous(regular(drinking(habits(we(have(been(able( to((dis+nguish(between(the(two(groups.(The(level(of(alcohol(consump+on(at( which(this(possible(protec+ve(effect(is(lost(and(alcohol(becomes(a(risk(factor( for(stroke(are(unknown. Study* We(report(the(findings(of(a(caseFcontrol(study(that(examines(the(contribu+on( Statement* of(alcohol(to(the(risk(of(stroke(in(moderate(and(heavy(drinkers((both(currently( and(previously),(lifelong(abstainers((those(who(have(never(drunk(alcohol),(and( current(abstainers((those(who(had(formerly(been(regular(drinkers(but(who( currently(do(not(drink(alcohol),(using(validated(measures(of(alcohol( consump+on. Summary* Statement* 71(
  • 70. Background* Between(May(2009(and(May(2010,(Greece(experienced(two(waves( Statement:* of(influenza(A(H1N1)2009(transmission* Problem* Given(the(poten+al(for(worsening(in(the(clinical(severity(of(influenza( Statement* during(the(postFpandemic(influenza(season,(as(was(the(case(for( ** previous(influenza(pandemics([7F9],(it(was(cri+cal(to(con+nue(* surveillance(with(a(focus(on(severe(cases(and(their(clinical( characteris+c Descrip2on*of* In(Greece,(influenza(is(annually(monitored(through(the(rou+ne( the* sen+nel(surveillance(system,(which(became(opera+onal(in(1999.(The( Surveillance* sen+nel(surveillance(system,(which(covers(approximately(three( System* percent(of(the(total(Greek(popula+on(in(the(2010/11(influenza( season,(provides(data(representa+ve(of(the(na+onal(popula+on Summary* This(report(summarises(data(from(influenza(surveillance(in(Greece( Statement* during(the(postFpandemic(2010/11(influenza(season.( 72(
  • 71. Materials(and(Methods( Purpose:(to(describe(how(you(collected,(organized( and(analyzed(data((relevant(to(the(study(purpose)(•  Clearly(present/define(all(analysis(variables(•  Organize(into(logical(subsec+ons(that(illustrate(the(steps( you(took(to(collect,(organize,(and(analyze(the(data:( o  Study(popula+on( o  Defini+on(of(variables( o  Laboratory(methods/(epidemiological(inves+ga+on( o  Interven+on(•  Describe(what(you(did,(not(what(you(found((Results)(•  Respect(chronology(•  Describe(the(original(methods(in(detail;(otherwise(give( references( Length(varies(depending(on(originality(of(methods( 73(
  • 72. Materials(and(Methods(–(part1(MethodsStudy(design Present(key(elements(of(study(design(early(in(the(paperSeing Describe(the(seing,(loca+ons,(and(relevant(dates,(including(periods(of( recruitment,(exposure,(followFup,(and(data(collec+onPar+cipants(and( (a)(Cohort(study—Give(the(eligibility(criteria,(and(the(sources(and(Seing methods(of(selec+on(of(par+cipants.(Describe(methods(of(followFup( CaseYcontrol(study—Give(the(eligibility(criteria,(and(the(sources(and( methods(of(case(ascertainment(and(control(selec+on.(Give(the(ra+onale( for(the(choice(of(cases(and(controls( CrossYsec6onal(study—Give(the(eligibility(criteria,(and(the(sources(and( methods(of(selec+on(of(par+cipants (b)(Cohort(study—For(matched(studies,(give(matching(criteria(and( number(of(exposed(and(unexposed( CaseYcontrol(study—For(matched(studies,(give(matching(criteria(and(the( number(of(controls(per(case 74(
  • 73. Materials(and(Methods(–(part2( Clearly(define(all(outcomes,(exposures,(predictors,(poten+al(Variables confounders,(and(effect(modifiers.(Give(diagnos+c(criteria,(if( applicableData(sources/( (For(each(variable(of(interest,(give(sources(of(data(and(details(of( methods(of(assessment((measurement).(Describe(comparability(measurement of(assessment(methods(if(there(is(more(than(one(group Describe(any(efforts(to(address(poten+al(sources(of(biasBias Explain(how(the(study(size(was(arrived(atStudy(size (a)(Describe(all(sta+s+cal(methods,(including(those(used(to(Sta+s+cal( control(for(confoundingmethods (b)(Describe(any(methods(used(to(examine(subgroups(and( interac+ons (c)(Explain(how(missing(data(were(addressed (d)(Cohort(study—If(applicable,(explain(how(loss(to(followFup(was( addressed( CaseYcontrol(study—If(applicable,(explain(how(matching(of(cases( and(controls(was(addressed( CrossYsec6onal(study—If(applicable,(describe(analy+cal(methods( taking(account(of(sampling(strategy (e)(Describe(any(sensi+vity(analyses 75(
  • 74. Study(Design(•  Observa+onal(or(Experimental(•  Retrospec+ve(or(Prospec+ve( 76(
  • 75. Seing(and(Par+cipants(•  Describe(the(study(popula+on(and(seing:(•  Descrip+on(should(involve(relevant( demographic,(environmental,(diagnos+c,( comorbid(factors(•  Defini+on(of(cohort/case(•  Exclusion/inclusion(criteria(•  How(was(consent(obtained?(•  Matching((in(caseFcontrol(study)( 77(
  • 76. Examples(of(seing(and(par+cipants(FF( cohort(Smoking(and(demen6a(in(male(Bri6sh(doctors:(prospec6ve(study((The(cohort(originally(comprised(34,439(male(doctors(on(the( Bri+sh( medical( register,( resident( in( the( United(Kingdom,( who( had( responded( to( a( ques+onnaire( about(their( smoking( habits( in( 1951.( Changes( in( such( habits(were(sought(in(1957,(1966,(1972,(1978,(1990,(and(1998,(and( other( personal( informa+on( was( sought( in( 1978,(1990,(and(1998.(In(1971,(follow(up(was(discon+nued(for(2459( subjects( (10.1%( of( the( survivors)( who( were( living(abroad( and( 218( (0.9%)( for( other( reasons.( Almost( all( of(the( remaining( survivors( have( con+nued( to( provide(informa+on(about(their(smoking(habits*.( 78(
  • 77. Examples(of(seing(and(par+cipants(–(( case(control( Alcohol(and(stroke.(A(caseYcontrol(study(of(drinking(habits(past( and(present( ( Cases*Three(hundred(sixtyFfour(consecu+ve(pa+ents(hospitalized(for( acute( stroke( in( Newcastle( upon( Tyne( between( August(1989( and( July( 1990( formed( the( study( popula+on.( No(pa+ent( refused( to( take( part( in( the( study.( Pa+ents( were(iden+fied(by(daily(contact(with(the(resident(medical(officer(and(completeness(of(case(ascertainment(was(checked(with(data( from( the( medical( records( department( at( each( of( the(three( par+cipa+ng( hospitals( (Freeman( Hospital,( Royal(Victoria( Infirmary,( and( Newcastle( General( Hospital)(Pa6ents( with( primary( subarachnoid( hemorrhage( were(excluded.(( 79(
  • 78. Examples(of(seing(and(par+cipants(–(( case(control((con+nued)(( Controls*Three(hundred(sixtyFfour(community(control(subjects(were(matched(for(age,(sex,(and(family(doctor.(Control(subjects(were(the(next(unrelated(matching(individual(to(the(case(in(the(family(doctor(register.(Control(subjects(with(a(previous(history(of(stroke(were(excluded.( 80(
  • 79. Examples(of(seing(and(par+cipants(–(( cross(sec+onal( Breast(feeding(and(obesity:(cross(sec6onal(study(The( 1997( obligatory( health( examina+on( before( school(entry( evaluated( 134,577( children( in( Bavaria,( southern(Germany.( At( the( examina+on,( the( parents( of( 13,345(children( seen( in( two( rural( regions( were( asked( to(complete( a( ques+onnaire( about( risk( factors( for( atopic(diseases.( Data( collected( by( this( ques+onnaire( were(linked( with( the( data( from( the( school( health(examina+on.( Our( analysis( was( confined( to( children(aged(5(and(6(who(had(German(na+onality.( 81(
  • 80. Examples(of(seing(and(par+cipants(–(( cross(sec+onal(Supplementary(feeding(with(either(readyYtoYuse(for6fied(spread(or(cornYsoy(blend(in(wasted(adults(star6ng(an6retroviral(therapy(in(Malawi:(randomised,(inves6gator(blinded,(controlled(trial((The(study(took(place(at(the(an+retroviral(therapy(clinic(of(Queen(Elizabeth(Central(Hospital(in(Blantyre,(Malawi,(from(January(2006(to( April( 2007.( Blantyre( is( the( major( commercial( city( of( Malawi,(with(a(popula+on(of(1,000,000(and(an(es+mated(HIV(prevalence(of(27%(in(adults(in(2004.Eligible(par+cipants(were(all(adults(aged(18( or( over( with( HIV( who( met( the( eligibility( criteria( for(an+retroviral( therapy( according( to( the( Malawian( na+onal( HIV(treatment( guidelines( (WHO( clinical( stage( III( or( IV( or( any( WHO(stage( with( a( CD4( count( <250/mm3)( and( who( were( star+ng(treatment( with( a( BMI( <18.5.( Exclusion( criteria( were( pregnancy(and( lacta6on( or( par6cipa6on( in( another( supplementary( feeding(program( 82(
  • 81. Seing(and(par+cipantsFSurveillance( (ONGOING(OUTBREAK(OF(WEST(NILE(VIRUS(INFECTION(IN(HUMANS,(GREECE,(JULY( TO(AUGUST(2011(CaseZDefini2on*•  (A(confirmed(case(is(defined(as(a(person(mee+ng(any(of(the( following(clinical(criteria:(encephali+s,(meningi+s,(fever( without(specific(diagnosis(and(at(least(one(of(the(four( laboratory(criteria:((i)(isola+on(of(WNV(from(blood(or( cerebrospinal(fluid((CSF),((ii)(detec+on(of(WNV(nucleic(acid(in( blood(or(CSF,((iii)(WNVFspecific(an+body(response((IgM)(in( CSF,(and((iv)(WNV(IgM(high(+tre,(and(detec+on(of(WNV(IgG,( and(confirma+on(by(neutralisa+on.( 83(
  • 82. Study(Variables(•  Specify(unit(of(measurement((if(applicable)(•  Quan+fy(exposure(•  Variable(transforma+ons(•  Criteria(for(defini+ons(•  Units(of(+me(and(special(categories( 84(
  • 83. Study(Variables((examples)(The( childrens( height( and( weight( were( measured( as(part(of(the(rou+ne(examina+on.(Body(mass(index(was(calculated( as( weight( (kg)/(height( (m)2).( The( age(specific(and(sex(specific(distribu+on(of(the(body(mass(index( among( all( children( with( German( na+onality( in(Bavaria,(which(had(been(inves+gated(during(the(1997(school(health(examina+on,(was(used(as(the(reference(for( being( overweight( (defined( as( body( mass( index(above(the(90th(cen6le)(or(obese((defined(as(body(mass(index( above( the( 97th( cen6le)( because( these( cen+les(were(higher(than(other(European(reference(values.(( 85(
  • 84. Study(Variables((examples)((Hypertension( was( iden6fied( by( medical( history( or(posi6ve(screening(results((systolic(pressure(≥140(mm(Hg).(PreYhypertension((asystolic(pressure(of(120–139(mm( Hg)( and( preYdiabetes( (a( fas6ng( blood( glucose(concentra6on( of( 6.1–6.9( mmol/L)( were( defined( on(the( basis( of( screened( laboratory( results.( Individuals(were( regarded( as( regular( alcohol( drinkers( if( they(consumed( two( or( more( alcoholic( drinks( a( day( on(three(or(more(days(a(week,(and(occasional(drinkers(if(they(consumed(less(than(regular(drinkers.( 86(
  • 85. Study(Variables((con+nued)(Data( from( clinic( visits( were( used( to( calculate( the( number( of( days( of(observa6on( per( quarter( for( each( pa+ent( in( each( of( four( categories( of(prescribed(an+retroviral(therapy.(These(categories,(in(increasing(order(of(intensity,(were(no(an+retroviral(therapy,(monotherapy,(combina+on(therapy( without( a( protease( inhibitor,( and( combina+on( therapy( that(included(a(protease(inhibitor.(((The( data( collected( for( each( case,( using( a( standardised( form,( were:(demographic( characteris+cs( (age,( sex),( dates( of( admission( to( the(hospital( and( the( ICU,( the( +me( course( of( illness( including( the( date( of(symptom( onset,( underlying( condi+ons,( complica+ons,( use( of(mechanical( ven+la+on( support( (dates( of( intuba+on( and( extuba+on),(and(an+viral(treatment( 87(
  • 86. Data(Sources/Management(•  How(the(data(were(collected(•  If(it(was(part(of(the(registry,(describe:( –  Original(purpose(of(the(database( –  How(large(the(database(is,(+meliness( –  Valida+on,(quality(checks( –  Error(rate(•  Database(sogware/hardware(•  For(surveillance(paper(–(a(diagram(of(the( surveillance(system(is(preferred( ( 88(
  • 87. Data(Sources/Management(Pa+ents( (with( a( close( rela+ve( or( significant( other(when( possible)( were( interviewed( and( examined( by(H.R.( (79%)( or( P.D.A.( within( 48( hours( of(hospitaliza+on.( Control( subjects( were( interviewed( in(their(homes(by(H.R.((also(with(a(rela+ve(or(significant(other( when( possible).( InterFobserver( valida+on(studies( between( the( two( interviewers( were( carried(out.( The( propor+on( of( agreement( between( two(observers,(K,(was(0.68.(( 89(
  • 88. Data(Sources/Management(Drinking( frequency( was( recorded( as( a( categorical(variable,( whereas( past( and( present( amounts( of(alcohol( consump+on,( dura+on( of( abs+nence,( and(heavy( drinking( were( recorded( as( con+nuous(variables.( Data( were( transferred( to( Northumbrian(Universitys( Mul6ple( Access( Computer( (NUMAC).(Following( verifica6on( procedures( to( ensure( accurate(transcrip6on,(data(were(analyzed(using(spssYx((SPSSYX(Batch(System,(SPSS(Inc.,(Chicago,(Illinois).( 90(
  • 89. Data(Sources/Management(•  Informa6on(in(five(general(categories(has(been(abstracted( from(the(chart(for(each(outpa6ent(visit(and(entered( electronically(by(trained(data(abstracters;(the(data(are( compiled(centrally,(reviewed,(and(corrected(before(being( included(in(the(data(base.(Because(the(study(physicians(are( the(source(of(primary(care(for(these(pa+ents,(all(symptoms,( diagnoses,(and(treatments(since(the(previous(visit,(are(noted( at(each(clinic(visit.(The(categories(of(informa+on(are(as( follows:(demographic(characteris+cs;(symptoms;(diagnosed( diseases;(medica+ons(prescribed;(and(laboratory(values.(( 91(
  • 90. Data(Sources/Management( 92(
  • 91. Study(Size(•  Specify(the(null(hypothesis(and(whether(it(is( one(or(twoFsided(•  Specify(the(minimum(difference(in(response( variable(that(is(considered(to(be(clinically( important(•  Specify(power(and(alpha(level(for(calcula+ng( sample(size( 93(
  • 92. Examples(To( detect( a( reduc+on( in( PHS( (postopera+ve(hospital( stay)( of( 3$ days$ (SD( 5( days),( which( is( in(agreement( with( the( study( of( Lobo( et( al.( with( a(twoFsided( 5%( significance( level( and( a( power( of(80%,(a(sample(size(of(50(pa+ents(per(group(was(necessary,( given( an( an+cipated( dropout( rate( of(10%.( To( recruit( this( number( of( pa+ents,( a( 12Fmonth(inclusion(period(was(an+cipated( 94(
  • 93. Examples(Based( on( an( expected( incidence( of( the( primary(composite(endpoint(of(11%(at(2.25(years(in(the(placebo( group,( we( calculated( that( we( would(need(950(primary(endpoint(events(and(a(sample(size( of( 9650( pa+ents( to( give( 90%( power( to(detect( a( significant( difference( between(ivabradine(and(placebo,(corresponding(to(a(19%$reduc;on$of$rela;ve$risk$(with(a(twoFsided(type(1(error(of(5%)( 95(
  • 94. Randomiza+on(–(( Randomized(controlled(trials((RCT)(Par+cipants( should( be( assigned( to(comparison( groups( in( the( trial( on( the(basis( of( a( chance( (random)( process(characterized(by(unpredictability(******( 96(
  • 95. ( Randomized(controlled(trials((RCT)(FF( examples(•  Independent(pharmacists(dispensed(either( ac+ve(or(placebo(inhalers(according(to(a( computer(generated(randomiza+on(list((•  For(alloca+on(of(the(par+cipants,(a( computerFgenerated(list(of(random(numbers( was(used(******( 97(
  • 96. Randomiza+on((con+nued)(•  Randomiza+on(sequence(was(created(using( Stata(9.0((StataCorp,(College(Sta+on,(TX)( sta+s+cal(sogware(and(was(stra+fied(by( center(with(a(1:1(alloca+on(using(random( block(sizes(of(2,(4,(and(6((•  Par+cipants(were(randomly(assigned(following( simple(randomiza+on(procedures( (computerized(random(numbers)(to(1(of(2( treatment(groups( 98(
  • 97. Randomiza+on(FF(Concealment(A( generated( alloca+on( schedule( should( be(implemented(by(using(alloca+on(concealment,(a( c r i + c a l( m e c h a n i s m( t h a t( p r e v e n t s(foreknowledge( of( treatment( assignment( and(thus(shields(those(who(enroll(par+cipants(from(being( influenced( by( this( knowledge.( The(decision( to( accept( or( reject( a( par+cipant(should(be(made,(and(informed(consent(should(be(obtained(from(the(par+cipant,(in(ignorance(of(the(next(assignment(in(the(sequence( 99(
  • 98. Randomiza+on((concealment)(The(doxycycline(and(placebo(were(in(capsule(form(and(iden+cal(in(appearance.(They(were(prepackaged( in( bosles( and( consecu+vely(numbered(for(each(woman(according(to(the(randomiza+on( schedule.( Each( woman( was(assigned( an( order( number( and( received( the(capsules( in( the( corresponding( preFpacked(bosle( 100(
  • 99. Blinding((RCTs)(The( term( “blinding”( or( “masking”( refers( to(withholding( informa+on( about( the( assigned(interven+ons(from(people(involved(in(the(trial(who(may( poten+ally( be( influenced( by( this( knowledge.(Blinding( is( an( important( safeguard( against( bias,(par+cularly(when(assessing(subjec+ve(outcomes.(EXAMPLE:(Whereas( pa+ents( and( physicians( allocated( to( the(interven+on( group( were( aware( of( the( allocated(arm,( outcome( assessors( and( data( analysts( were(kept(blinded(to(the(alloca+on.( 101(
  • 100. Laboratory(Methods(Surveillance)(Serum(and(CSF(specimens(were(tested(for(the(presence(of(WNVFspecific(IgM(and(IgG(an+bodies(using(commercial(ELISA(kits((WNV(IgM(capture(DxSelect(and(WNV(IgG(DxSelect,(Focus(Diagnos+cs(Inc,(Cypress,(CA,(USA).(WNV(posi+ve(specimens(were(also(tested(for(the(presence(of(other(flaviviruses:(+ckFborne(encephali+s(virus((TBEV)(and(dengue(virus((DENV).( 102(
  • 101. Sta+s+cal(Methods(•  Describe(all(sta+s+cal(methods,(including(those( used(to(control(for(confounding(•  Describe(the(comparisons(to(be(made(and(the( sta+s+cal(procedures(to(be(used(for(making(them(•  State(whether(the(sta+s+cal(analysis(will(be(on( the(basis(of(inten+onFtoFtreat(•  Control(for(mul+ple(tes+ng(problem(•  Report(hypothesis(power(and(level((if(it(is(not( reported(in(sampling(sec+on)(•  Report(all(required(pFvalues(and(confidence( intervals( 103(
  • 102. Assessment(of(risk(ra+on( Sick *******************Not*sick* ****Cases * *Controls* ( ( ( ( No*history*of*disease***** *History*of*disease****************Exposed********Not*exposed* A( В( A( В( ( ( ( ( С( D( С( D( In(case(control(study(the(risk(ra+on(has(no(outcome,(odds(ra+on(used( instead(
  • 103. Repor+ng(sta+s+cal(methods(in( (CrossFSec+onal(studies(•  Standard(descrip+ve(sta+s+cs:( FSimple(prevalence(calcula+on(•  Prevalence(of(disease(or(prevalence(of( exposure(•  Regression(to(control(confounders( 105(
  • 104. CrossFsec+onal(study(example:( Sta+s+cal(Methods(Pa+ent( characteris+cs,( adjusted( for( stone( history(and(age,(were(compared(using(linear(regression(for(con+nuous( covariates( and( logis6c( regression( for(categorical( covariates.( Mul6ple( linear( regression(was(used(to(compare(mean(es+mated(GFR(between(stone( formers( and( nonFstone( formers.( Covariates(iden+fied( as( poten+al( confounders( in( the(rela+onship( between( es+mated( GFR( and( stone(history(were(adjusted(for.(Mul6plica6ve(interac6ons(between( stone( history( and( age,( gender,( race,(diabetes,(and(BMI(were(formally(tested.(( 106(
  • 105. CrossFsec+onal(study(example:( Sta+s+cal(Methods(Mul6nomial(logis6c(regression(was(used(to(compare(the( rela+ve( risk( of( having( an( es+mated( GFR( in( a(lower( category( rela+ve( to( the( highest( category(between( persons( with( and( without( nephrolithiasis.(Model(based(es+mates(are(reported(as(rela6ve(risk(ra6os( comparing( stone( formers( with( nonFstone(formers.( Adjustment( covariates( included( in( the(mul+nomial(logis+c(regression(included(age,(gender,(race,( BMI,( systolic( blood( pressure,( HbA1c,( diabetes,(history( of( cardiovascular( disease,( smoking( status,(health( insurance( status,( and( use( of( prescrip+on(diure+cs.( 107(
  • 106. CrossFsec+onal(study(example( Sta+s+cal(Methods(•  The(prevalence(of(overweight(and(obese(children(were( calculated(according(to(the(dura+on(of(breast(feeding.( The(appropriate(χ2$tests$were(used(to(compare(several( items(in(breasÜed(and(nonFbreasÜed(children(and(their( associa+on(with(the(child(being(overweight(or(obese.( Logis6c(regression(models(were(used(to(assess(the( impact(of(variables(that(were(significantly(associated( (P<0.05)(with(both(breast(feeding(and(being(overweight( or(obese(Confounding(was(assumed(to(have(occurred(if( the(odds(ra6o(changed(by(≥10%.(Confounders(and( independent(risk(factors(were(included(in(the(final( logis6c(regression(model.(All(calcula+ons(were(carried( out(with(the(SAS(sogware(package,(version(6.12.( 108(
  • 107. Sta+s+cal(Methods((CaseFcontrol)(•  Comparing(groups:( –  Nominal((chiFsquared(or(McNemar’s(test)( –  Ordinal((Wilcoxon,(signedFrank,(KruskalFWallis,( ANOVA)( –  Con+nuous((tFtest,(ANOVA)(•  Odds(ra+os(–(strength(of(associa+on(between( exposure(and(disease(is(commonly(measure(by( an(OR(•  Logis+c(Regression:(to(make(inference(on( exposureFdisease(associa+on(while(adjus+ng(for( covariates( 109(
  • 108. Repor+ng(Sta+s+cal(Methods(in(CaseF Control(Study(The(MannYWhitney(U(test(was(used(for(between(group(analyses(of(nonparametric(data,(the(standard(χ2(test(when(appropriate(for(discrete(variables,(and(McNemars(χ2(test(to(compare(discordant(pairs.(The(odds(ra6o((OR)(with(95%(confidence(intervals((CIs)(was(used(as(an(es+mate(of(risk.(LogFlinear(analysis(was(used(to(calculate(the(adjusted(odds(ra+o(for(poten+al(confounding(variables.( 110(
  • 109. Repor+ng(Sta+s+cal(Methods(in(Cohort( Studies(and(Clinical(Trials(•  TimeFtoFevent(data:(Survival(func+ons( –  Describe(censored(data(( –  Confirm(that(requirements(have(been(met(•  KaplanFMeier(analysis(•  Specify(methods(to(compare(two(or(more(survival( curves(logFrank(or(Wilcoxon)(•  Hazard(ra+o(•  Cox(Propor+onal(Hazards(Model( –  Report(measure(of(risk(for(each(variable(•  Repeated(measures(for(mul+ple(+me(points)(•  ANCOVA(for(primary(and(secondary(endFpoints(•  Number(of(end(points(( 111(
  • 110. Repor+ng(Sta+s+cal(Methods(in(Cohort( Studies(and(RCTs(As(preFspecified,(efficacy(analyses(were(performed(with( the( use( of( a( modified( inten+onFtoFtreat(approach,(which(included(the(randomized(pa+ents(and( the( endFpoint( events( that( occurred( ager(randomiza+on(and(no(later(than(the(comple+on(of(the(treatment(phase(of(the(study((i.e.,(the(globalFtreatment( end( date),( 30( days( ager( early(permanent( discon+nua+on( of( the( study( drug,( or(30( days( ager( randomiza+on( for( pa+ents( who( did(not(receive(a(study(drug( 112(
  • 111. Repor+ng(Sta+s+cal(Methods(in(Cohort( Studies(and(RCTs((con+nued)(We(used(hazard(ra6os(and(twoFsided(95%(confidence(intervals(to( compare( the( study( groups.( Rates( of( the( end( points( were(expressed( as( Kaplan–Meier( es+mates( through( 24( months.(Tes+ng(was(preFspecified(to(occur(between(the(combinedFdose(group(for(rivaroxaban(and(placebo(at(an(alpha(level(of(0.05(on(the( basis( of( the( logYrank( test,( stra+fied( according( to( the(inten+on(to(use(a(thienopyridine.(If(this(comparison(significantly(favored(rivaroxaban,(then(each(of(the(two(doses(of(rivaroxaban(was( simultaneously( compared( with( placebo( with( the( use( of( a(similar( stra+fied( logFrank( test( at( an( alpha( level( of( 0.05( on( the(basis( of( the( closed( tes+ng( procedure.( Results( were( examined(according( to( major( subgroups( for( general( consistency( of(treatment(effect,(and(interac+on(tes+ng(was(performed.( 113(
  • 112. Repor+ng(Sta+s+cal(Methods(in( Randomized(Controlled(Experiments(The( primary( endpoint( was( change( in(bodyweight( during( the( 20( weeks( of( the( study(in( the( inten+onFtoFtreat( popula+on( …(Secondary(efficacy(endpoints(included(change(in( waist( circumference,( systolic( and( diastolic(blood( pressure,( prevalence( of( metabolic(syndrome(…( 114(
  • 113. Repor+ng(Sta+s+cal(Methods(in( Randomized(Controlled(Experiments(We( used( an( analysis* of* covariance* (ANCOVA)( for(the(primary(endpoint(and(for(secondary(endpoints(waist( circumference,( blood( pressure,( and( pa+entFreported( outcome( scores;( this( was( supplemented(by( a( repeated( measures( analysis.( The( ANCOVA(model( included( treatment,( country,( and( sex( as(fixed( effects,( and( bodyweight( at( randomiza+on( as(covariate.( We( aimed( to( assess( whether( data(provided(evidence(of(superiority(of(each(liraglu+de(dose( to( placebo( (primary( objec+ve)( and( to( orlistat((secondary(objec+ve( 115(
  • 114. Repor+ng(Sta+s+cal(Methods(in( Cohort(Studies(and(RCTs(We( calculated( hazard( ra6os( (HR)( to( compare( mortality(risks( between( individuals( in( different( exercise( groups((grouped(by(volume(of(exercise)(and(those(in(the(inac+ve(group.( We( used( a( Cox( propor6onate( model( to( analyze(categorical(and(con+nuous(variables(…((The( life( table( method( was( used( to( es+mate( life(expectancy.(We(calculated(adjusted(odds(ra+os(and(95%( CIs( by( comparing( the( propor+on( of( individuals(mee+ng(ac+vity(recommenda+ons(with(the(propor+on(of(those(who(were(inac+ve(within(each(characteris+c(group( 116(
  • 115. Sta+s+cal(Methods(F(Surveillance(•  Exploratory(data(analysis:( –  Incidence(by(age,(sex,(geography( –  Trends(•  Severity(factors(•  Group(comparisons(( –  Two(sample(tests,(etc.(•  Event(detec+on( –  Detec+on(methods(+me(series/spa+otemporal)( –  Timeliness( –  Sensi+vity/Specificity( ( 117(
  • 116. Sta+s+cal(Methods(F(Surveillance(•  For(early(detec+on(of(localized(clusters(of(dead((birds,(we( used(a(prospec+ve(surveillance(system((that(is(based(on( the(spa+al(scan(sta+s+c((9).(This((scan(sta+s+c(uses(a( circular(window(to(represent(poten+al(geographic(clusters.(•  Temporal(trends(in(annual(no+fica+on(rates(of( salmonellosis,(infec+ous(diarrhoea(and(outbreaks(of(foodF borne(diseases(were(assessed(using(the(Cuzick(test([9].( Annual(rates(of(salmonellosis(and(infec+ous(diarrhoea( were(compared(between(the(sexes(using(the(Mann– Whitney(test(and(among(age(groups(using(the(Kruskal– Wallis(test.(Post(hoc(paired(comparisons(ager(the(Kruskal– Wallis(test(were(tested(using(the(Mann–Whitney(test(on( each(pair(of(age(group(and(pFvalue(adjustment(according( to(Bonferroni’s(method([10]( 118(
  • 117. Results(Purpose:(to(describe(the(results(of(data(analysis(that(are(relevant(to(the(study(purpose(•  Start(with(the(tables(and(figures.((Write(the(text(later.( o  Use(tables(to(highlight(individual(values( o  Use(figures(to(highlight(trends(and(rela+onships(•  Text(supplements(and(reinforces(tables(and(figures( o  Summarize/emphasize(highlights( o  Fill(in(gaps((ogen(minor)(•  Present(results(in(a(logical(sequence(•  Describe(what(you(found,(not(what(you(did((Methods)(•  Consider(subFsec+ons(similar(to(the(ones(in(Methods(•  Look(to(published(ar+cles(for(poten+al(templates( 119(
  • 118. Results((con+nued)(Tables/Figures(•  Check(your(math;(provide(consistent(row(or(column( summa+on.(•  Keep(lines(to(a(minimum;(avoid(ver+cal(lines.(•  Use(footnotes(to(clarify(points(of(poten+al(ambiguity.(•  Check(headings,(labels(of(rows/columns/axes,(and(footnotes(Text(•  Highlight(key(rela+onships(between(dependent/independent( variables.(•  Present(a(logical(sequence:(( o  in(parallel(with(methods((consider(similar(subheadings)( o  background(data(→(descrip+ve(→(bivariate(→(mul+variate(•  Make(sure(all(numbers(in(text(are(consistent(with(tables/ figures.((($$$$( Oaen(requires(just(three(paragraphs(+(three(tables/figures( 120(
  • 119. Tables(versus(Figures(Tables:(beser(to(use(when(knowledge(of(individual(values(or(sta+s+cs(are(more(important(than(trends(and(conceptual(understanding( 1.  Title( 2.  Column/row(headings( 3.  Data(fields( 4.  Footnotes( 5.  Spanner( 121(
  • 120. Five(elements(of(a(table( 122(
  • 121. Table(Title:(Example(Example(1:(( (Sta+n(therapy(and(cancer(recurrence.(Example(2:(( (Effect(of(daily(oral(primvasta+n(or(dorvasta+n(on(the(4Fyear(odds(ra+o(for(the(recurrence(of(prostate(and(breast(cancer.(Example(3:(( (The(effect(of(daily(oral(primvasta+n(or(dorvasta+n(on(the(4Fyear(odds(ra+o((OR)(for(the(recurrence(of(prostate(and(breast(cancer(shows(a(3Ffold(lower((P(=(0.002)(OR(for(the(recurrence(of(breast(cancer(for(pa+ents(receiving(primvasta+n((OR(=(2.3)(versus(dorvasta+n((OR(=(6.8).( 123(
  • 122. Tables(:(General(Recommenda+ons(•  Indicate(missing(data(by(using(a(dash,(NA,(or(…(•  Each(footnote(should(be(placed(on(a(separate(line(at( the(bosom(of(the(table(•  Lesers((or(numbers,(or(symbols)(designa+ng( footnotes(should(be(ordered(alphabe+cally((or( numerically)(•  The(symbol(designa+ng(a(footnote(that(applies(to( the(en+re(table(should(be(placed(ager(the(+tle( 124(
  • 123. Table(Alignment(•  The(stubs(should(be(all(leg(jus+fied(•  In(the(columns/data(fields,(words(should(be(leg( jus+fied(and(whole(numbers(rightFjus+fied((•  Data(fields(containing(decimal(points,(plus/minus( symbols,(slashes,(hyphens,(or(parentheses(should( be(aligned(on(these(elements.(•  When(the(text(in(a(stub(wraps(to(a(second(line,( the(corresponding(data(field(should(align(with(the( top(line(of(the(stub.( 125(
  • 124. Table(alignment(example(A.*Annual*per*capita*healthcare*expenditures.* Expenditure,($(Israel* 1971(Madagascar* 36(Sweden* 2828(Yemen* 82(Zimbabwe* 149(B.*Annual*per*capita*healthcare*expenditures.* Expenditure,($( Israel* 1971( Madagascar* 36( Sweden* 2828( Yemen* 82( Zimbabwe* 149(C.*Annual*per*capita*healthcare*expenditures.* Expenditure,($(Sweden* 2828(Israel* 1971(Zimbabwe* 149(Yemen* 82(Madagascar* 36( 126(
  • 125. Tables,(column(formats(example(Table 3. Phenytoin concentrations measured by immunoassay for matricessupplemented with 10 mg/L phenytoin.# Mean (SD), mg/ Mean ± SD, mg/ Deviation from L L target, %Pig serum 11.4 (2.1) 11.4 ± 2.1 14Sheep serum 10.7 (1.4) 10.7 ± 1.4 7Artificial 10.3 (0.8) 10.3 ± 0.8 3serumSaline 10.1 (0.6) 10.1 ± 0.6 1Human serum 9.9 (0.6) 9.9 ± 0.6 −1Cow serum 9.6 (1.4) 9.6 ± 1.4 −4Horse serum 8.9 (0.7) 8.9 ± 0.7 −11 Two*different*styles**of*presen2ng*results** 127(
  • 126. What(is(the(right(size?(•  60(characters(for(halfFpage,(120(for(full(•  For(a(2Fcolumn(journal,(110(characters(would(fit( onto(a(portraitFformased(page.(•  Otherwise(journal(might(publish(landscape((•  ReForient(if(number(of(column(headings(:(row( headings(greater(2:1(•  If(only(one(pFvalue(out(of(the(whole(column(is( significant(–(remove(and(place(a(not(in(a(footnote(•  Use(abbrevia+ons(when(journals(permit(it(•  Split(into(2( 128(
  • 127. Example(:(Table(Too(Wide( Table 5. Age-related 5-year survival for forms of acute myelogenous leukemia.# Microkar Undiffer Myelobla Promyelo Myelomon Monocyti Megakary Erythrol yoblastiAge, entiated stic cytic ocytic c eukemia, c oblasticyears leukemia leukemia leukemia leukemia leukemia leukemia % leukemia , % , % , % , % , % , % , %<21 91 80 85 81 82 73 62 5221–40 89 83 79 77 68 61 57 4141–60 74 62 68 59 40 37 31 24>60 51 48 39 34 28 21 16 9 129(
  • 128. Table,(reForiented(Table*7.(AgeFrelated(5Fyear(survival(for(forms(of(acute(myelogenous(leukemia((AML) ( Age AML type <21 Years 21–40 Years 41–60 Years >60 YearsUndifferentiated, % 91 89 74 51Myeloblastic, % 80 83 62 48Promyelocytic, % 85 79 68 39Myelomonocytic, % 51 48 39 34Monocytic, % 82 68 40 28Erythroleukemia, % 73 61 37 21Microkaryoblastic, % 62 57 31 16Megakaryoblastic, % 52 41 24 9 130(
  • 129. Formaing(tables,(con+nued(Table 6. Previous studies of leukocyte reduction during kelvac therapy in patients withchronic myelogenous leukemia.# Leukocyte count, %a No. of Study Day Day Day Day Day Day Day patients 0 7 14 21 28 56 84Wilkins and Potter, Refb11 M11;F11 100 97 — 84 — — 70Pillsbury et al., Ref 12 M10;F18 100 100 81 — 76 — 64Annesley et al., Ref 18 M27;F20 100 89 76 — 63 — 62Kronnenberg and M9;F7 100 103 95 — 88 69 —Stenmeyerson, Ref 20Flowers and Peterson, Ref M20;F23 100 101 96 93 89 86 9825Flloyd et al., Ref 26 M27;F23 100 95 — — 91 — 79Robinson et al., Ref 27 M19;F20 100 — 100 — 96 — 94Nowicki and Phillips, Ref M15;F16 100 — 92 — 82 74 —32 Are(these((columns(necessary?( 131(
  • 130. Figures(•  Proper+es(of(a(good(graph:( –  Draws(asen+on(to(the(data(and(not(the(graph( –  The(symbols(and(connec+ng(lines(are(easy(to(read( –  Axis(number(and(labels(are(easy(to(read( –  The(lengths(of(the(two(axes(are(balance(((1:1.3)( –  The(scales(used(on(each(axis(match(the(range( –  Tick(marks(are(used(appropriately( –  The(legend(is(clear(and(concise( –  SelfFsufficient(( –  The(data(deserve(to(be(graphed( 132(
  • 131. Common(Mistakes(Plasma*vs.*serum*sodium*for*paired*specimens*from*150*pa2ents.*(A),(xF(and(yFaxis(scales(of(0–165(mmol/L;(((B),(xF(and(yFaxis(scales(of(120–170(mmol/L;(((C),(Bland–Altman(plot.( 133(
  • 132. Using(appropriate(axis(interval( 134(
  • 133. Why(include(this(graph?( 135(
  • 134. Results(vs.(Data( Figure(1(shows(the(survival(rates(following( diagnosis(and(ini+a+on(of(treatment(in(the(3( treatment(groups.(At(6(months(the(survival( rates(were(95%(for(the(A(group,(91%(for(the(B( group,(and(39%(for(the(radia+onFtreated( group.(At(12(months(the(rates(were(83%,(69%,( and(23%;,(at(18(months(74%,(17%,(and(15%;( and(at(24(months(were(70%,(11%,(and(9%.( Data*but*no*results* Results,*but*no*data*Figure(1(shows(the(survival(rates(following(diagnosis(and(ini+a+on(of(treatment(in(the(3(treatment(groups.(At(6(months(the(survival(rates(were(significantly(higher(in(the(A(and(B(treatment(groups(compared(with(the(radia+onFtreatment(group.(At(12,(18,(and(24(months(the(survival(rates(in(the(A(group(exceeded(those(of(both(the(B(and(radia+onFtreatment(groups.( 136(
  • 135. Results(vs.(Data( Six( months( ager( diagnosis( and( ini+a+on( of(treatment,(the(survival(rates(for(the(A( and( B( groups( were( 2.4( and( 2.3( +mes( higher,( respec+vely,( than( the( radia+on( treatment( group( (both( P( <( 0.001),( but( survival( rates( were( not( found( to( differ( between( the( A( and( B( groups( (P( =( 0.56)( (Figure( 1).( By( 12( months,( however,( pa+ent( survival( in( the( A( group( was( 1.2( +mes( higher( than( in( the( B( group( (P( =( 0.031),( and( 4.3( and( 6.4( +mes( higher( at( 18(and(24(months((both(P(<0.001).( 137(
  • 136. Results(and(only(the(Results(We( compared( the( death( rates( for( the( 262( healthy( controls(with(those(of(the(203(conges6ve(heart(failure(pa6ents(over(a(2Yyear( period.( Survival( curves( were( generated( with( the(Masterson( mortality( index( formula.( The( conges+ve( heart(failure(group(was(found(to(have(a(significantly(higher(shortFterm(mortality(rate.(When( the( 2Fyear( survival( curves( for( healthy( controls( and(conges+ve( heart( failure( pa+ents( were( compared,( the(conges+ve( heart( failure( group( was( found( to( have( a(significantly(higher(shortFterm(mortality(rate.( 138(
  • 137. Using(modern(graphics(and(visualiza+on(
  • 138. Using(modern(graphics(and(visualiza+on( PennFstate(university:(mul+Fpurpose(map(with(+me(and(spa+al(flu(cases( distribu+on(support(
  • 139. Using(modern(graphics(and(visualiza+on( Red(–(anger,(blue(–(dissa+sfac+on,(yellow(–(joy,(emo+ons(in( blog(community(
  • 140. Использование(современных(графиков(и(методов(визуализации(Popula+on(distribu+on(by(countries(
  • 141. Results(F(Key(Tables(•  Study(flow(•  Comparison(between(study(and(control(group(at(baseline((so( groups(are(comparable)( –  Give(characteris+cs(of(study(par+cipants((e.g.(demographic,( clinical,(social)(and(informa+on(on(exposures(and(poten+al( confounders( –  (Cohort(study—Summarise(followFup(+me((e.g.,(average(and( total(amount)(•  Primary(comparison(table( –  (cohort,(RCT)(Report(absolute((and(rela+ve)(differences(for( primary(endpoints( –  (cohort,(RCT)(Report(95%(CI(for(primary(endpoints( –  (caseFcontrol)Report(numbers(in(each(exposure(category,(or( summary(measures(of(exposure( –  (crossFsec+onal)(Report(numbers(of(outcome(events(or( summary(measures( 143(
  • 142. Results(F(Key(Tables((con+nued)(•  Main(Results:( – (Give(unadjusted(es+mates(and,(if( applicable,(confounderFadjusted( es+mates(and(their(precision((e.g.,(95%( confidence(interval).(Make(clear(which( confounders(were(adjusted(for(and(why( they(were(included( – (Report(category(boundaries(when( con+nuous(variables(were(categorized( – (If(relevant,(consider(transla+ng( es+mates(of(rela+ve(risk(into(absolute( risk(for(a(meaningful(+me(period( 144(
  • 143. Results(Checklist(Par+cipants( Report(number(of(individuals(at(each( stage(of(the(study( • Consider(flow(diagram( • Give(reasons(for(nonFpar+cipa+on(Baseline(Data( Baseline(demographic(and(clinical( characteris+cs(for(each(group(Variables/Outcomes( Report(numbers(of(outcome(events(or( summary(measures(over(+me(Main(results( Give(unadjusted(es+mates(and(if( applicable,(confounderFadjusted( es+mates(and(their(precision.((Adverse(effects( Readers(need(informa+on(on((for(Experimental(Designs)( poten+al(harm(as(well(as(benefit( 145(
  • 144. Results(examples(T h e ( n e x t ( s e v e r a l ( s l i d e s(demonstrate( different( ways( to(present(results( 146(
  • 145. Results:(CONSORT(Flow( Eligible(( NonFeligible( Declined( Alloca+on(using( randomiza+on( scheme( FollowFup( Included(in( analysis( 147(
  • 146. Results(–(sample(study(flow( 148(
  • 147. Results(–(baseline(comparison( 149(
  • 148. Results:(Primary(outcome((RCT)( 150(
  • 149. Results(–(primary(outcomes((RCT)( 151(
  • 150. Results:(Primary(outcome((RCT)( 152(
  • 151. Results(–(primary(outcome((cohort)( 153(
  • 152. Primary(outcome((alterna+ve(figure)( 154(
  • 153. Primary(Efficacy(End(Point((RCT)( 155(
  • 154. Results(–(primary(outcome( (CrossFsec+onal) (( 156(
  • 155. Regression(with(primary(outcomes( (CrossFsec+onal(study)( 157(
  • 156. Results(–(Regression(with(OddsFRa+os( 158(
  • 157. ResultsFReport(Adverse(Effects(“The( propor+on( of( pa+ents( experiencing( any( adverse( event(was( similar( between( the( rBPI21( [recombinant( bactericidal/permeabilityFincreasing( protein]( and( placebo( groups:( 168((88.4%)( of( 190( and( 180( (88.7%)( of( 203,( respec+vely,( and( it(was( lower( in( pa+ents( treated( with( rBPI21( than( in( those(treated( with( placebo( for( 11( of( 12( body( systems( …( the(propor+on( of( pa+ents( experiencing( a( severe( adverse( event,(as( judged( by( the( inves+gators,( was( numerically( lower( in( the(rBPI21( group( than( the( placebo( group:( 53( (27.9%)( of( 190(versus( 74( (36.5%)( of( 203( pa+ents,( respec+vely.( There( were(only( three( serious( adverse( events( reported( as( drugFrelated(and(they(all(occurred(in(the(placebo(group.”( 159(
  • 158. Discussion( Purpose:(to(interpret(your(results(and(jus+fy(your( interpreta+on(•  Dis+ll(the(essence(of(your(study( o  ReFstate(key(results( o  State(main(conclusion( ! Be(clear(about(why(results(support(the(conclusion( ! Maintain(connec+on(with(the(purpose(of(the(study(•  Interpret(your(study(in(the(context(of(the(literature( o  Compare(with(results(of/methods(used(in(related(studies( o  Emphasize(strengths(of(your(study(and(what(is(new(•  State(limita+ons/caveats((frankly,(without(apology)(•  Make(recommenda+ons( o  Changes(in(prac+ce/policy( o  Future(studies,(including(some(specifics((e.g.(study(method)( Oaen(requires(just(four(or(five(paragraphs( 160(
  • 159. Discussion(Checklist( *Dis2ll*the*essence*of*study* a.  Restate*key*results* b.  State*main*conclusion*Z*Be*clear*about*why*results*support*the*conclusion.*Z*Maintain*connec2on*with*purpose*of*the*study. (Interpret*your*study*in*the*context*of*the*literature* a.  Compare*with*results*of/methods*used*in*related*studies* b.  Emphasize*strengths*of*your*study,*and*what*is*new (State*limita2ons/caveats*(use*examples)*Discuss*limita2ons*of*the*study,*taking*into*account*sources*of*poten2al*bias*or*imprecision.*Discuss*both*direc2on*and*magnitude*of*any*poten2al*bias (Make*recommenda2ons* a.  changes*in*prac2ce/policy* b.  future*studies,*including*some*specifics*(e.g.*study*method) 161(
  • 160. Discussion((Examples)(During(periods(of(seasonal(influenza(ac+vity,(we(found(moderately(ac+ve((1.5–2.9(METs/day)(and(ac+ve((≥3.0(METs/day)(individuals(to(be(approximately(15%(less(likely(to(have(an(influenzaFcoded(physician(office(or(emergency(department(visit(compared(to(inac+ve(individuals.(When(stra+fied(by(age,(we(observed(similar(findings(among(individuals(<65(years(but(not(≥65(years((( KEY(RESULTS((Among(individuals(<65(years,(moderately(ac+ve(and(ac+ve(individuals(were(not(more(likely(than(inac+ve(individuals(to(visit(physicians(for(nonFinfluenzaFrelated(condi+ons(such(as(derma++s(or(periodic(health(examina+ons(during(influenza(season…( MAIN(CONCLUSIONS( 162(
  • 161. Discussion((Examples)(Aging( is( linked( to( declines( in( the( ability( to( defend(against(pathogens([40],(and(has(been(associated(with(increased( morbidity( and( mortality( from( infec+ous(diseases( in( the( elderly( [40]–[41].( Addi+onally,( ageFrelated( declines( in( immune( response( to( influenza(vaccines( are( well( documented( [42]–[44].( The(reduced(immune(func+on(of(the(elderly(may(prevent(them( from( receiving( any( immune( system( benefits(from( physical( ac+vity.( [Comparison* with* other*studies]* 163(
  • 162. Discussion((Examples)(To( our( knowledge,( this( is( the( first( epidemiologic( study( that( has(examined( the( rela6onship( between( physical( ac6vity( and(influenzaYrelated( morbidity( during( seasonal( influenza( epidemics.(Previous(studies(have(mostly(focused(on(upper(respiratory(tract(infec+ons( (URTIs)( with( an( emphasis( on( athletes( [4],( and( only( a(few( focused( on( the( general( popula+on( [12],( [19],( [45].( Our(finding(of(a(15%(reduc+on(in(influenzaFcoded(outpa+ent(visits(is(similar( to( the( 20%( reduc+on( in( URTIs( observed( in( popula+onFbased( studies,( although( those( studies( used( selfFreported(outcome(measures([12],([19],([45].(Only(one(other(study(assessed(the( associa6on( between( physical( ac6vity( and( influenza,( and( the(outcome( was( influenzaYassociated( mortality( [9].( Although( a(beneficial(effect(was(found,(our(study(suggests(a(protec6ve(effect(at(a(much(earlier(stage(than(mortality.( 164(
  • 163. Discussion((Examples)(F(limita+ons(This(study(had(several(limita+ons.(First,(our(outcome(measure(was(influenzaYcoded(outpa6ent(visits(rather(than(laboratoryYconfirmed(influenza(infec6ons,(which(would(be(the(most(ideal(outcome(measure(A(second(limita+on(is(that(measurement(of(physical(ac6vity(and(certain(covariates(relied(on(selfYreport,(and(verifica6on(of(subject(responses(was(not(possible((First,(we(are(limited(in(our(ability(to(adequately(es+mate(an(associa+on(between(stone(history(and(renal(func+on(in(young(adults(due(to(a(lack(of(data(on(stone(formers(less(than(age(30( 165(
  • 164. Discussion(F(Recommenda+ons(Future( research( should( ideally( use( laboratoryFconfirmed( influenza( outcomes( to( confirm( the(associa+on( between( physical( ac+vity( and(influenza(infec+on.(Public(health(authori+es(and(clinicians(should(work(toward(a(common(goal(of(increasing( physical( ac+vity( and( the( public’s(awareness( of( its( benefits.( These( ac+ons( may(help( to( mi+gate( the( health( and( economic(burden(caused(by(influenza.(( 166(
  • 165. Discussion(F(Recommenda+ons((Further( work( in( alternate( study( samples( is( needed(to( validate( this( finding( and( to( determine( the(mechanisms( for( the( associa+on( between( kidney(stones(and(decreased(GFR.(However,(this(is(the(first(study( to( show( such( a( connec+on( in( a( na+onally(representa+ve( sample( of( the( United( States(popula+on.( Given( our( observa+ons,( the( serious(nature(of(renal(disease(and(the(increasing(incidence(of( nephrolithiasis( in( the( United( States,( further(inves+ga+on(is(warranted.( 167(
  • 166. Abstract(Purpose:(to(highlight(key(points(from(major(sec+ons(of(the(ar+cle( Component* Abstracted*from* Major(purpose(of(study( (((Introduc+on( Basic(procedures( (((Methods( Main(findings( (((Results( Principal(conclusions( (((Discussion( Emphasize(what(is(new(and(useful( 168(
  • 167. Synopsis(–(Find(weaknesses( Reliability of information about risk factors of chronic diseases collected in Missouri through the Behavioral Risk Factors Surveillance System. Synopsis (initial version) The Behavioral Risk Factors Surveillance System is widely used by health care authorities of the States to measure the prevalence of risk factors of chronic diseases. Despite its extensive utilization, only a few studies that assess reliability and validity of collected data have been conducted. A double testing study was carried out in the State of Missouri to assess reliability of information collected through the System. Authors repeatedly interviewed 222 people by phone, who passed full interview in March-April 1993. The repeated interview was conducted after 6-30 days following the first one. Repeatability of results was high for demographic data (kappa 0.85-1.00). Reliability of information about chronic diseases and risk factors thereof was also high. Kappa values ranged from 0.82 for the question about hypertension up to 1.00 for the question about smoking at that moment. In respect of the cancer survey procedures the reliability was lower for the knowledge of prostate cancer detection tests (kappa 0.21), than the tests used to diagnose cancer in women (mammography and smears). The question about attitude to smoking showed lower reliability than the question about actions to combat smoking. In general our data demonstrate flexibility of the System and its applicability to collecting information.
  • 168. Synopsis(–(Published(version:(Find(weaknesses( The Behavioral Risk Factors Surveillance System is widely used by health care authorities of the States to measure the prevalence of risk factors of chronic diseases. We carried out a double testing study to assess reliability of information collected through the System in the State of Missouri. We repeatedly interviewed 222 people by phone, who passed full interview in March-April 1993. The repeated interview was conducted after 6-30 days following the first one. Repeatability of results was high for demographic data (kappa 0.85-1.00). Reliability of information about chronic diseases and risk factors thereof was also high. Kappa values ranged from 0.82 for the question about hypertension up to 1.00 for the question about smoking at that moment. In respect of the cancer survey procedures the reliability was lower for the knowledge of prostate cancer detection tests (kappa 0.21), than the tests used to diagnose cancer in women (mammography and smears). The question about attitude to smoking showed lower reliability than the question about actions to combat smoking.
  • 169. Structured(Synopsis(DECREASE OF MORTALITY OF RECTAL CANCER BY IMPLEMENTATION OF SCREENING FOR BLOOD IN FECES Introduction. Although tests to detect blood in feces are widely used to diagnose rectal cancer, there are no evidences that such use can result into decrease of mortality of this type of cancer. We conducted a randomized survey of the use of the method and showed its efficiency. Methods. 46,551 participants of the survey aged 50-80 were randomly selected either for the control group or for one of the test groups. The rectal cancer screening was carried out once a years in the first group, and once in two years in the second one. Those with positive test results passed through additional examination, including colonoscopy. Mortality statistics were collected for all participants over 13 years observation period. A group of experts determined causes of death, and an autopsist (pathologist) determined a stage of cancer for each case. Variations in mortality of rectal cancer were assessed by special statistical methods. Results. Total mortality of rectal cancer over the 13 year period was worth 5.88 per 1,000 (95% confidence interval 4.61-7.15) in the annually screened group, 8.44 (95% confidence interval 6.82-9.84) in the biannually screened group, and 8.83 (95% confidence interval 7.26-10.40) in the control group. This indicator in the first screened group (not the second one) was certainly lower as compared to the control group. This group showed detection of cancer at earlier stage, and the forecast of the survival rate in patients was better along with decrease of mortality. Conclusions. Annual tests to detect blood in feces decreased total mortality of rectal cancer by 33% within 13 years.
  • 170. Finalizing(the(paper(and(submission( •  Drag(a(+tle( •  Wri+ng(and(edi+ng(process( •  Picking(a(journal( •  Last(sec+ons(:(( –  References( –  Special(men+on( •  Transla+on( 172(
  • 171. Title(Purpose:(to(provide(a(brief,(informa+ve(summary(that(will(asract(your(target(audience( What(goes(into(the(+tle?(•  The(topic((T)(–(study(subjects(and(seing( o  Who,(what,(when,(where(•  In(addi+on,(chose(one(or(two(among:( o  M(–(Methods( o  R(–(Results( o  C(–(Conclusions( o  N(–(name(of(study(or(data(set( Highlight(what(is(new(and(useful( 173(
  • 172. Title(examples( Title* ******T*******M*******R*******C*******N*•  Longitudinal(evalua6on(of(prostrateY •  +((((((((+( specific(an6gen(levels(in(men(with(and( ( without(prostrate(disease(o  An(injury(preven+on(program(in(an( o  +( AfricanFAmerican(community( (•  Smoking,(pregnancy,(and(source(of(preY •  +(((((((((((((((((((((((((((((((((((+( natal(care:(Results(from(the(Pregnancy( Risk(Assessment(Monitoring(System( (o  Reduc+on(of(highFrisk(sexual(behavior( o  +((((((((+(((((((?( among(heterosexuals(undergoing(HIV( an+body(tes+ng:(A(randomized(clinical( trial( 174(
  • 173. Examples(of(+tles:(Your(opinion?(Title * ( ( ( ( ((((((((((((((((((T(((((M((((((R((((((C(((((((N ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( Massive(mailing(does(not(effect(the(use(of(vaccines(among(( MedicAir(Medical(insurance(recipients( ( Nurses(stress(factors(in(neonatal(Intensive(Case(Units:( American(Study( ( Experience(and(sa+sfac+on(of(primary(care,(secondary( Analysis(with(mul+level(modeling( ( ( HIV(mortality(and(infec+vity(in(India:(assessment(of(( na+onalFrepresenta+ve(census(1.1(mln(of(residents( 175
  • 174. Racial(difference(of(Survival(with(Oral(cancer(in(Georgia((Time(of(experiment(implementa+on:(Racial(difference(of(Survival(with(Oral(cancer(in(Georgia:(1978F2001((Which(race(s)(under(higher(risk?((Reduced(survival(among(AfroFAmerican(pa+ents(with(oral(cancer(in(Georgia:(1978F2001((The(analysis(controlled(the(major(risk(factors:(Reduced(survival(among(AfroFAmerican(pa+ents(with(oral(cancer(in(Georgia(ager(Risk(Factors(Control:(1978F2001((Data(source?(Reduced(survival(among(AfroFAmerican(pa+ents(with(oral(cancer(in(Georgia(ager(Risk(Factor(Control:(Georgia(Registra+on(Index(SEER,(1978F2001((The(higher(risk(limited(by(several(subgroups(of(AfroFAmerican(pa+ents:(Reduced(survival(among(subgroups(of(AfroFAmerican(pa+ents(with(oral(cancer(in(Georgia(ager(Risk(Factor(Control:(Georgia(Registra+on(Index(SEER,(1978F2001( (( 176
  • 175. Title(requirements( Bri2sh*Medical*Journal*(BMJ):* The(+tle(must(include(study(design(if(presented(as(an(original(study( * American*Journal*of*Preven2ve*Medicine* Title(must(be(brief(but(informa+ve,(underline(but(not(describe,(serve(as(a(shortcut( but(not(an(offer,(reflect(what(was(done,(do(not(use(verbs,(include(nouns(for(easier( search,(do(not(use(symbols(or(abbrevia+ons( (*ICMJE*(Interna2onal*Commidee*of*Medical*Journals*Editors)*:* Short(+tles(easier(to(read.(Too(short(+tles(may(lack(the(informa+on(about,(for( example,(the(study(design.(Authors(encouraged(to(include(all(possible( informa+on(into(the(+tle(which(will(make(the(search(more(sensible(and(relevant. *
  • 176. Wri+ng(the(ar+cle(and(submiing(it( to(a(journal( 178(
  • 177. Wri+ng(and(submiing(the(ar+cle(•  Conduct(literature(review(•  Start(the(paper!(•  Conduct(study/analyze(data(•  Organize/summarize(results(succinctly(•  Get(early,(frequent(feedback((in(pieces)(•  Formulate(your(key(message(•  Apply(the(“new/useful”(test(•  Choose(your(target(audience(•  Choose(your(target(journal(•  Read(journal(instruc+ons(to(authors( 179(
  • 178. Wri+ng(and(submiing(the(ar+cle(•  Drag((and(debug)(an(abstract(•  Write(the(first(drag(•  Master(the(literature(•  Relearn,(rethink,(and(rewrite(•  …and(rewrite,(rewrite,(rewrite(•  How(long?(•  Cri+cally(review(and(finalize(the(abstract(•  Asend(to(the(details(•  Submit(ar+cle(to(the(target(journal(•  Have(a(“Plan(B”( 180(
  • 179. Conduct(literature(review(•  Google(scholar(•  PubMed(–(try(“Single(Cita+on(Matcher”(•  Web(of(Knowledge(•  NIHFfunded(research((RePORTER)(•  Contact(leading(inves+gators(to(learn(about( inFpress(or(unpublished(work(•  Scopus(•  Medline.ru(•  Elibrary.ru( 181(
  • 180. Start(the(paper!(•  Yes,(even(before(you(do(the(study(•  Drag(the(introduc+on(–(perhaps(borrow(from( a(study(protocol(or(grant(proposal(that(you( already(wrote(•  Drag(dummy(table(shells(and(figure(axes(for( Results(•  Decide(which(sta+s+cal(methods(you(may( need(–(may(dictate(study(design( 182(
  • 181. Conduct(study/analyze(data( 183(
  • 182. Organize/summarize(results(succinctly(•  Fill(in(dummy(tables(and(figures(with(real( data(•  Drag(addi+onal(tables(and(figures(if(needed(–( look(at(published(ar+cles(for(poten+al( templates(•  Summarize(each(table(or(figure(in(a(single( sentence( 184(
  • 183. Get(early,(frequent(feedback((in(pieces)(•  Ask(coauthors/colleagues(if(your(tables/figures( and(text(summaries(are(clear/concise/compelling(•  Give(presenta+ons(to(colleagues(and(at( conferences(•  The(more(hurdles(you(clear(before(you(submit( your(paper(to(a(journal,(the(fewer(you(will(be( asked(to(clear(during(the(review(process(•  Don’t(wait(for(a(complete(drag(to(begin(geing( feedback( 185(
  • 184. Formulate(your(key(message(•  Keep(it(simple;(try(to(boil(down(to(a(single( sentence(•  Your(message(must(contain(something(new( and(useful*•  Make(sure(your(results(support(your(key( message(•  The(message(may(change(as(you(develop(the( paper( 186(
  • 185. Apply(the(“new/useful”(test(•  Journal(editors(are(interested(in(new( informa+on(that(is(useful(to(their(target( audience(•  Does(your(study(meet(these(criteria?(•  If(not,(the(effort(of(wri+ng(a(manuscript(may( not(be(warranted(•  If(yes…( 187(
  • 186. Choose(your(target(audience(What(audience(is(most(interested(in(your(message?( o  Clinicians?( o  Public(health(prac++oners?( o  Basic(scien+sts?( o  A(broad(audience?( 188(
  • 187. Choose(your(target(journal(•  Journal(impact(factor(•  Select(based(on:( o  Match(with(target(audience( o  Strength(of(your(ar+cle(•  Consider(aiming(high(–(reviewer(comments( from(a(highFlevel(journal(can(be(valuable(•  However,(aiming(high(with(data(that(are( geing(“stale”(is(risky(( 189(
  • 188. Read(journal(instruc+ons(to(authors(•  Find(your(target(journal(“instruc+ons(for( authors”(on(the(Internet(or(in(an(issue(of(the( journal(•  Is(your(key(message(relevant(to(the(target( journal’s(mission(statement?( 190(
  • 189. Drag((and(debug)(an(abstract(•  Check(for(internal(consistency( o  Logical(flow(from(Purpose(to(Methods(to(Results( to(Conclusion?( o  Conclusion(consistent(with(the(Purpose?(•  If(you(see(flaws(in(the(Abstract,(ask(yourself:( o  Do(I(need(to(do(addi+onal(analyses?( o  Addi+onal(literature(review?( o  Addi+onal(thinking?( 191(
  • 190. Write(the(first(drag(•  Write(for(your(target(audience((use( appropriate(terminology(or(jargon)(•  Consider(using(an(outline(•  Don’t(spend(too(much(+me(on(the( grammar,(syntax,(or(details((only(you( need(to(understand(the(first(drag)( 192(
  • 191. Master(the(literature(•  As(you(obtain(feedback,(colleagues(will( direct(you(to(new(references(•  Update(your(PubMed(Single(Cita+on( Matcher(search((•  Russian(Scien+fic(Cita+on(Index(•  (and/or(local(UZ(equivalent)( 193(
  • 192. Relearn,(rethink,(and(rewrite(•  As(you(master(the(literature,(you(will(see( your(work(in(a(new(light(•  Transmit(this(new(thinking(to(your( manuscript( 194(
  • 193. …(and(rewrite,(rewrite,(rewrite(•  Most(papers(require(at(least(five(drags,( maybe(ten(–(save(and(date(them(all(•  You(may(need(to(revise(your(key(message(•  Perhaps(consider(changing(target(audience,( target(journal(•  Perhaps(your(paper(is(now(beser(than(you( ever(imagined,(and(you(want(to(aim(for(a( higherFcircula+on/impact(journal( 195(
  • 194. How(long?(•  How(long(should(your(manuscript(be?(•  Follow(guidance(in(target(journal’s( instruc+ons(for(authors(•  “Shorter(papers(get(luckier(faster”( 196(
  • 195. Cri+cally(review(and(finalize(the(abstract( •  Check(again(for(internal(consistency((as( described(previously)( •  Make(sure(the(abstract(is(fully*consistent( with(the(body(of(the(ar+cle( 197(
  • 196. Asend(to(the(details(•  Carefully(review(and(comply(with(target( journal’s(instruc+ons(for(authors(•  Call/eFmail(the(journal(if(you(s+ll(have( ques+ons( 198(
  • 197. Submit(ar+cle(to(target(journal( 199(
  • 198. Have(a(Plan(B(Decide(on(your(next(target(journal(in(case(you(receive(a(rejec+on( 200(
  • 199. About(the(importance(of(opportunity( and(impact(•  As(to(how(being(opportunis+c( can(lead(to(high(acceptability(of( research(grants(and(scien+fic( outputs((examples(of( bioterrorism(research(in(the(US( ager(2001,(or(the(large(number( of(papers(and(research(that( focus(on(Q(fever,(for(example,( ager(the(outbreak(in(the( Netherlands).(•  But(watch(out(because(the( search(for(high(impact( publica+ons(can(lead(to( “miscarriages”((the(case(of( Wakefield)( 201(
  • 200. Wri+ng(for(Grant(Proposals( Eugene(Elbert,(MS(( Johns(Hopkins(University,(U.S.A.( August(2012( (
  • 201. Phases(of(Grant(Wri+ng(1.  Planning2.  Preparing3.  Writing4.  Submitting 203(
  • 202. 1.(Planning(•  Research funder’s program areas and priorities. –  What other projects have been funded?•  Read the instructions!•  For a specific RFP (request for proposals), READ the RFP!•  Does your project match the funder’s needs?•  Do you have the capacity to do the proposed project?•  Be familiar with the submission process –  Is there an online submission process?
  • 203. 2.(Preparing(•  Develop(your(idea( –  Is(it(new?(Interes+ng?(( –  What(are(the(specific(aims?( –  What(is(your(research(design?( –  What(will(the(outcomes(be?(•  What(will(it(take(to(make(it(successful?( –  Who(will(lead(the(project?(( –  Who(else(will(be(involved?(( •  Internal(staff(and(external(partners( –  How(long(will(it(take(to(accomplish?( –  How(much(money(will(it(take?(
  • 204. 2.(Preparing((con+nued)(•  Get(organized( –  Read(the(RFP(again( –  Is(a(leser(of(intent((LOI)(needed(before(the(full( proposal(can(be(submised?(•  Develop(a(+meline(for(wri+ng(the(grant( proposal( –  Be aware of deadlines. Start early!$•  Assign(roles(in(the(proposal(process( –  Will(different(people(write(different(parts?( 206(
  • 205. 3.(Wri+ng(•  Follow(direc+ons( –  Are(you(including(everything(as(requested?( –  Pay(asen+on(to(format(and(page(limits.(•  Make(it(easy(for(the(reviewer(to(read( –  Be(clear(and(concise( –  Use(buzzwords(that(will(stand(out(and(show(your( work(is(aligned(with(the(funder’s(goals(and(mission.( –  Do(not(use(jargon( –  Spell(out(abbrevia+ons(and(acronyms( 207(
  • 206. 3.(Wri+ng((con+nued)(•  Title( –  Make(it(interes+ng(and(clear( –  Does(it(capture(what(you(will(do?( –  Look(at(+tles(of(other(projects(the(funder(has( funded(for(format(•  Know(the(review(process( –  How(will(the(proposal(be(scored?( –  Is(one(part(more(important(than(another?( 208(
  • 207. What(the(customer(wants…(Innova+on(( •  New(methods(for(old(problems((examples)( •  Old(methods((elsewhere)(for(old(problems( (examples)( •  Any(method(for(new(problems((BE(THE(FIRST)( o First(papers,(no(maser(how(precarious( become(seminal(ones((1)(( ( (1) Ugbomoiko et al. 2008. Parasites of importance for human health in Nigerian dogs: high prevalence and limited knowledge of pet owners. BMC Vet Research. 209(
  • 208. Parts(of(a(Grant(Proposal(NOTE: These are are different for different funders –read the instructions!1.  Cover(leser(2.  Summary(or(abstract(3.  Problem(or(Needs(statement(4.  Project(descrip+on( •  Introduc+on( •  Objec+ves(( •  Methods(5.  Evalua+on(6.  Key(personnel(7.  Budget( 210(
  • 209. The(Sec+ons(1.  Cover*leder* –  One(page(leser(addressed(to(the(funding(source( and(signed(by(the(highest(official(2.  Summary*or*abstract*3.  Problem*or*Needs*Statement* –  State(the(problem(with(facts(and(evidence(that( support(the(need(for(your(project.( –  Be(sure(to(use(accurate(data.( 211(
  • 210. The(Sec+ons((con+nued)(4.  Project Description –  Introduc2on(( •  Provide(history(of(organiza+on(and(experience(of(your( team( •  How(does(this(work(fit(into(what(has(been(done(previously( by(you(and(others?( –  Objec2ves** •  List(2F4(Specific(Aims(of(the(project( •  Define(the(measurable(outcomes(of(your(program.( –  Methods** •  What(ac+vi+es(that(will(take(place(to(achieve(the( objec+ves?( •  What(is(the(research(design?( 212(
  • 211. The(Sec+ons((con+nued)(5.*Evalua2on* –  How(you(will(measure(the(success(of(your(project?( –  Plan(for(con+nua+on(beyond(the(grant(period(6.*Key*personnel* –  Describe(the(people(needed(to(do(project( –  What(are(the(qualifica+ons(of(the(project(director(and( others?( –  What(are(their(roles(on(the(project(((Director,(Program( Manager,(Sta+s+cian,(etc.(7.*Budget* –  How(much(will(it(cost(to(conduct(the(project?( –  Be(aware(of(funding(limitsF(do(not(ask(for(more(than(they( are(giving(out( –  Provide(jus+fica+on(of(costs(* 213(
  • 212. 4.(Submiing(•  Review your work –  Have you followed instructions? –  Ask someone from outside of your team to review your proposal to get a new perspective•  Revise –  Correct any errors –  Make as clear and concise as possible•  Submit –  Follow directions 214(
  • 213. More(Informa+on(Grant(Wri+ng(Tips(Sheet([hsp://grants1.nih.gov/grants/grant_+ps.htm]((Common(Grant(Applica+on((Na+onal(Network(of(Grantmakers)([hsp://www.nng.org/cga.html]((EPA(Purdue(University(GrantFWri+ng(Tutorial((Environmental(Protec+on(Agency)([hsp://www.purdue.edu/envirosog/grants/src/msieopen.htm]((Sample(proposals:([hsp://www.npguides.org/guide/sample_proposals.htm]((Grants(and(Grant(Proposal(Wri+ng((St.(Louis(University)([hsp://eweb.slu.edu/papers2/grant01v32e.pdf]((All(About(Grants(Tutorials((Na+onal(Ins+tutes(of(Health)([hsp://www.niaid.nih.gov/ncn/grants/default.htm](( 215(