Successful(Scien+fic(Wri+ng(Eugene(Elbert,(MS((Johns(Hopkins((

University,(U.S.)(Special(thanks(to(:(Paul(Siegel(MD,(MPH(

9F10(August(2012(

Biological(Threat(Reduc+on(Program((of(the(

Defense(Threat(Reduc+on(Agency((DTRA)(

(

2(

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(

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(

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(

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(

Successful(Scien+fic(Wri+ng(

9(

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(

Why(do(we(publish?(

•  Presen+ng(research(•  Reaching(global(scien+fic(community(

•  Advancing(science(•  Educa+on(•  Funding(and(credibility((

11(

12(

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(

Process(of(scien6fic(wri6ng(

Hypothesis(

Study(plan(

Experiment(

Data(processing(Results(genera+on(

Having((

journal,(

audience((

in(mind(

Wri+ng((ar+cle(

Submiing(

14(

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(

•  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(

General(Guidelines(for(Scien+fic(Papers:(Style(and(Content(

16(

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(

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(

•  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.(

Repor+ng(Guidelines:(Content(

19(

A(Dic+onary(of(Useful(Research(Phrases(((•  "It(has(long(been(known..."(

•  "It(is(believed(that..."(•  "It(is(generally(believed(

that..."(

•  "A(sta+s+cally(oriented(projec+on..."(

•  “Typical(results(are(shown”(•  “Obviously,(we(will(need(

addi+onal(studies”(•  “Authors(thanks(Joe(in(

conduc+ng(experiment(and(George(for(helpful(comments”(

•  I(didn't(look(up(the(original(references(

•  I(think(•  My(friends(think(so,(too(

(

•  Wild(guess(

•  Best(results(are(shown(•  I(don’t(understand(anything((

•  Joe(did(the(work(and(George(explained(it(to(me(

(

20(

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(

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(

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(

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(

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(

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(

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(

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(

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(

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(

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(

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(

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(

Fallacies(in(Wri+ng(*Texas*Sharpshooter*Fallacy**

*

((

•  In(medical(research,(this(fallacy(occurs(when(inves6gators(select(certain(data(to(demonstrate(a(causeYeffect(rela6onships.(

34(

Outbreak(foci?(

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(

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(selfFcita+on(

•  Survey(found(that(having(a(tenure(posi6on(also(increased(coercion(

•  Lesson:((Being(true(to(your(work(

36(

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(

7/28/2012(

•  Argumentum$ad$Populum*(Appeal*to*the*People*or*Popularity)((

•  4(from(5(den+sts(recommend(sugarFfree(“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].»(

Fallacies(in(wri+ng ((

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(

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(

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(

Fallacies(in(Wri+ng(

42(

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.”(

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(

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(

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(

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(

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(MetaFanalyses((under(CONSORT)(

47(

Example(–(STROBE(checklist ((Item No Recommendation

Title 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 found

Introduction Background/rationale 2 Explain the scientific background and rationale for the

investigation being reported Objectives 3 State specific objectives, including any prespecified

hypotheses Methods Study design 4 Present key elements of study design early in the paper Setting 5 Describe the setting, locations, and relevant dates,

including periods of recruitment, exposure, follow-up, and data collection

Participants 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(

Study(Designs(in(Public(Health(

Experimental*(Interven2onal)*Studies* Observa2onal*Studies*

Randomized(Trials( Case(reports(

Community(Trials( Case(Series(

Therapeu+c/Preven+ve(Trials( CrossFsec+onal(Studies(

Surveillance((

Cohort(Studies((

CaseFControl(

Descrip+ve(

Analy+c(

49(

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(

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(

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(

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(

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(

Cohort(vs.(CaseFControl(

Popula+on(

Sample(of(diseaseFfree(individuals(

Exposed(

Not(Exposed(

Develop(Illness(

Don’t(Develop(Illness(

Exposed(

Not(Exposed(

Exposed(

Not(Exposed(

Sick(

Not(Sick(

Sick(

Not(Sick(

COHORT(STUDY(DATA(COLLECTION(

CaseFControl(Data(Collec+on( 55(

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(

Experimental:(Controlled(Studies(

Sample(of(diseaseFfree(individuals(

Exposed(

Not(Exposed(

Sick(

Not(Sick(

Sick(

Not(Sick(

(DATA(COLLECTION(

Exposure(occurs(naturally(

Inves+gator(Determines(Exposure(

COHORT((Observa+onal)(

CONTROLLED((Interven+onal)(

57(

Randomized(Clinical(Trial(

Experimental(Popula+on(

(

Reference(Popula+on((

• (Sample(size(should(be(sufficient(• (Possibility(to(follow(up(during(the(trial(• (Par+cipants(should(be(informed(of(risks/(benefits/(blinding/(placebo(• (Inclusion(Criteria(

Experimental(Popula+on(

(

Reference(Popula+on((

Study(Popula+on(

Internal(Validity( External(Validity(58(

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(

Randomized(Trial:(CONSORT(Flow(

Eligible((NonFeligible(Declined(

Alloca+on(using(randomiza+on(scheme(

FollowFup(

Included(in(analysis(

60(

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(

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(…(

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(industrial(chemicals(

Cohort(studies(in(a(popula+on(group(in(which(there(has(been(exposure((e.g.(industrial(workers)(

Study(of(mul+ple(exposures,(such(as(the(combined(effect(of(oral(contracep+ves(and(smoking(on(myocardial(infarc+on(

Case(control(studies(

Study(of(mul+ple(end(points,(such(as(mortality(from(different(causes(

Cohort(studies(

Es+mate(of(the(incidence(rate(in(exposed(popula+ons(

Exclusively(cohort(studies(

Study(of(covariables(which(change(over(+me(

Preferably(cohort(studies(

Study(of(the(effect(of(interven+ons( Interven+on(studies(63(

Ecological*study*

CrossZsec2onal*study*

CaseZcontrol*study*

Cohort*study(and*RCT)*

Selec+on(bias(

N/A( 2( 3( 1(

Recall(bias( N/A( 3( 3( 1(

Loss(to(followFup(

N/A( N/A( 1( 3(

Confounding( 3( 2( 2( 1(

Time(Required(

1( 2( 2( 3(

Costs( 1( 2( 2( 3(

1Fslight;(2Fmoderate;(3Fhigh;(N/A=(not(applicable(

Costs(of(different(types(of(bias(for(different(study(designs(

64(

Introduc+on(sec+on(

•  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(

Purpose:(to(convince(the(reader(that(your(study(will(yield(knowledge(or(knowFhow(that(is(new(and(useful(

Oaen(requires(just(three(paragraphs(65(

Introduc+on(Checklist(Background Statement:

Scope nature magnitude of the gap Be clear that filling the gap is useful

Problem Statement Describe relevant limitations

Study Statement Be clear that your approach is new Emphasize that your approach addresses limitations

Summary Statement Summarizes the study

66(

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+on

Background/ra+onale 2 Explain(the(scien+fic(background(and(ra+onale(for(the(inves+ga+on(being(reported

Objec+ves 3 State(specific(objec+ves,(including(any(preFspecified(hypotheses

67(

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(

Background*Statement:*

*

The(treatment(of(human(immunodeficiency(virus((HIV)(infec+on(has(undergone(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*Statement*

***

Several(reports(have(described(reduc+ons(in(mortality(and(in(the(rate(of(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*Statement*

This(report(outlines(the(changes(in(death(rates(and(the(incidence(of(opportunis+c(infec+ons(in(a(large(group(of(HIVFinfected(outpa+ents,(many(of(whom(had(previously(received(extensive(treatment.

69(

Background*Statement:*

*

Among(the(few(diseases(claimed(to(occur(more(ogen(in(nonFsmokers(than(smokers(1(2(that(of(greatest(poten+al(importance(is(Alzheimer's(disease,(which(accounts(for(most(of(the(demen+as(of(later(life(in(Britain

Problem*Statement*

***

The(published(epidemiological(evidence,(although(sugges+ve(of(an(inverse(rela+on(with(smoking,(is(not(conclusive(either(about(Alzheimer's(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*Statement*

We(sought(evidence(from(the(cohort(of(Bri+sh(doctors(who(have(been(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(

Background*Statement:*

*

Alcohol(was(first(implicated(as(a(possible(risk(factor(for(stroke(in(1725(1)(Several(epidemiological(studies(now(suggest(a(UFshaped(associa+on(between(alcohol(intake(and(stroke(2).

Problem*Statement*

***

Previous((studies(have(been(cri+cized(for(not(differen+a+ng(between(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*Statement*

We(report(the(findings(of(a(caseFcontrol(study(that(examines(the(contribu+on(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(

Background*Statement:*

*

Between(May(2009(and(May(2010,(Greece(experienced(two(waves(of(influenza(A(H1N1)2009(transmission

Problem*Statement*

***

Given(the(poten+al(for(worsening(in(the(clinical(severity(of(influenza(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*the*Surveillance*System*

In(Greece,(influenza(is(annually(monitored(through(the(rou+ne(sen+nel(surveillance(system,(which(became(opera+onal(in(1999.(The(sen+nel(surveillance(system,(which(covers(approximately(three(percent(of(the(total(Greek(popula+on(in(the(2010/11(influenza(season,(provides(data(representa+ve(of(the(na+onal(popula+on

Summary*Statement*

This(report(summarises(data(from(influenza(surveillance(in(Greece(during(the(postFpandemic(2010/11(influenza(season.(

72(

Materials(and(Methods(

•  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(

Purpose:(to(describe(how(you(collected,(organized(and(analyzed(data((relevant(to(the(study(purpose)(

Length(varies(depending(on(originality(of(methods( 73(

Materials(and(Methods(–(part1(Methods Study(design Present(key(elements(of(study(design(early(in(the(paper

Seing Describe(the(seing,(loca+ons,(and(relevant(dates,(including(periods(of(

recruitment,(exposure,(followFup,(and(data(collec+on

Par+cipants(and(

Seing

(a)(Cohort(study—Give(the(eligibility(criteria,(and(the(sources(and(

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(

Variables Clearly(define(all(outcomes,(exposures,(predictors,(poten+al(confounders,(and(effect(modifiers.(Give(diagnos+c(criteria,(if(applicable

Data(sources/(

measurement

(For(each(variable(of(interest,(give(sources(of(data(and(details(of(methods(of(assessment((measurement).(Describe(comparability(of(assessment(methods(if(there(is(more(than(one(group

Bias Describe(any(efforts(to(address(poten+al(sources(of(bias

Study(size Explain(how(the(study(size(was(arrived(at

Sta+s+cal(

methods

(a)(Describe(all(sta+s+cal(methods,(including(those(used(to(control(for(confounding (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(

Materials(and(Methods(–(part2(

Study(Design(

•  Observa+onal(or(Experimental(

•  Retrospec+ve(or(Prospec+ve(

76(

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(

Examples(of(seing(and(par+cipants(FF(cohort(

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*.(

Smoking(and(demen6a(in(male(Bri6sh(doctors:(prospec6ve(study((

78(

Examples(of(seing(and(par+cipants(–((case(control(

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.(

(

Alcohol(and(stroke.(A(caseYcontrol(study(of(drinking(habits(past(

and(present((

79(

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(

Examples(of(seing(and(par+cipants(–((cross(sec+onal(

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.(

Breast(feeding(and(obesity:(cross(sec6onal(study(

81(

Examples(of(seing(and(par+cipants(–((cross(sec+onal(

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(

Supplementary(feeding(with(either(readyYtoYuse(for6fied(spread(or(cornYsoy(blend(in(

wasted(adults(star6ng(an6retroviral(therapy(in(Malawi:(randomised,(inves6gator(

blinded,(controlled(trial(

(

82(

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(

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(

Study(Variables((examples)(

The( children's( 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(

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(

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(

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(

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(

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(

University's( Mul6ple( Access( Computer( (NUMAC).(

Following( verifica6on( procedures( to( ensure( accurate(

transcrip6on,(data(were(analyzed(using(spssYx((SPSSYX(

Batch(System,(SPSS(Inc.,(Chicago,(Illinois).(

90(

•  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.((

Data(Sources/Management(

91(

Data(Sources/Management(

92(

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(

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(

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(

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(

(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(

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(

Randomiza+on(FF(Concealment(

A( generated( alloca+on( schedule( should( be(implemented(by(using(alloca+on(concealment,(a( c r i+ca l( mechan i sm( that( p revents(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(

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(

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(

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(

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(

(A(

(В(

(С(

(D(

Sick *******************Not*sick*

***************Expo

sed********Not*exposed

*

****Cases * *Controls*

No*history*of*disease******History*of*d

isease*

Assessment(of(risk(ra+on(

(A(

(В(

(С(

(D(

In(case(control(study(the(risk(ra+on(has(no(outcome,(odds(ra+on(used(instead(

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(

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(

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(

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(

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(

Repor+ng(Sta+s+cal(Methods(in(CaseFControl(Study(

The(MannYWhitney(U(test(was(used(for(between(group(analyses(of(nonparametric(data,(the(standard(χ2(test(when(appropriate(for(discrete(variables,(and(McNemar's(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(

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(

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(

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(

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(

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(

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(

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(

•  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(foodFborne(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](

Sta+s+cal(Methods(F(Surveillance(

118(

Results(

•  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(

Purpose:(to(describe(the(results(of(data(analysis(that(are(relevant(to(the(study(purpose(

119(

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(

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(

Five(elements(of(a(table(

122(

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(

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(

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(

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(

Table(alignment(example(

126(

Tables,(column(formats(example(

Mean (SD), mg/L

Mean ± SD, mg/L

Deviation from target, %

Pig serum 11.4 (2.1) 11.4 ± 2.1 14 Sheep serum 10.7 (1.4) 10.7 ± 1.4 7 Artificial serum 10.3 (0.8) 10.3 ± 0.8 3

Saline 10.1 (0.6) 10.1 ± 0.6 1 Human serum 9.9 (0.6) 9.9 ± 0.6 −1 Cow serum 9.6 (1.4) 9.6 ± 1.4 −4 Horse serum 8.9 (0.7) 8.9 ± 0.7 −11

Table 3. Phenytoin concentrations measured by immunoassay for matrices supplemented with 10 mg/L phenytoin.#

Two*different*styles**of*presen2ng*results**127(

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(

Example(:(Table(Too(Wide(

Age, years

Undifferentiated leukemia

, %

Myeloblastic

leukemia, %

Promyelocytic

leukemia, %

Myelomonocytic

leukemia, %

Monocytic

leukemia, %

Erythroleukemia,

%

Microkaryoblasti

c leukemia

, %

Megakaryoblastic leukemia

, %

<21 91 80 85 81 82 73 62 52

21–40 89 83 79 77 68 61 57 41

41–60 74 62 68 59 40 37 31 24

>60 51 48 39 34 28 21 16 9

Table 5. Age-related 5-year survival for forms of acute myelogenous leukemia.#

129(

Table,(reForiented(

AML type Age

<21 Years 21–40 Years 41–60 Years >60 Years

Undifferentiated, % 91 89 74 51

Myeloblastic, % 80 83 62 48

Promyelocytic, % 85 79 68 39

Myelomonocytic, % 51 48 39 34

Monocytic, % 82 68 40 28

Erythroleukemia, % 73 61 37 21

Microkaryoblastic, % 62 57 31 16

Megakaryoblastic, % 52 41 24 9

Table*7.(AgeFrelated(5Fyear(survival(for(forms(of(acute(myelogenous(leukemia((AML)(

130(

Formaing(tables,(con+nued(

Study No. of patients

Leukocyte count, %a Day 0

Day 7

Day 14

Day 21

Day 28

Day 56

Day 84

Wilkins and Potter, Refb11 M11;F11 100 97 — 84 — — 70

Pillsbury et al., Ref 12 M10;F18 100 100 81 — 76 — 64

Annesley et al., Ref 18 M27;F20 100 89 76 — 63 — 62

Kronnenberg and Stenmeyerson, Ref 20 M9;F7 100 103 95 — 88 69 —

Flowers and Peterson, Ref 25 M20;F23 100 101 96 93 89 86 98

Flloyd et al., Ref 26 M27;F23 100 95 — — 91 — 79

Robinson et al., Ref 27 M19;F20 100 — 100 — 96 — 94

Nowicki and Phillips, Ref 32 M15;F16 100 — 92 — 82 74 —

Table 6. Previous studies of leukocyte reduction during kelvac therapy in patients with chronic myelogenous leukemia.#

Are(these((columns(necessary?(

131(

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(

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(

Using(appropriate(axis(interval(

134(

Why(include(this(graph?(

135(

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*

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.(

Results,*but*no*data*

136(

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(

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(

Using(modern(graphics(and(visualiza+on(

Using(modern(graphics(and(visualiza+on(

PennFstate(university:(mul+Fpurpose(map(with(+me(and(spa+al(flu(cases(distribu+on(support(

Using(modern(graphics(and(visualiza+on(

Red(–(anger,(blue(–(dissa+sfac+on,(yellow(–(joy,(emo+ons(in(blog(community(

Использование(современных(графиков(и(методов(визуализации(

Popula+on(distribu+on(by(countries(

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(

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(

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((for(Experimental(Designs)(

Readers(need(informa+on(on(poten+al(harm(as(well(as(benefit(

145(

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(

Results:(CONSORT(Flow(

Eligible((NonFeligible(Declined(

Alloca+on(using(randomiza+on(scheme(

FollowFup(

Included(in(analysis(

147(

Results(–(sample(study(flow(

148(

Results(–(baseline(comparison(

149(

Results:(Primary(outcome((RCT)(

150(

Results(–(primary(outcomes((RCT)(

151(

Results:(Primary(outcome((RCT)(

152(

Results(–(primary(outcome((cohort)(

153(

Primary(outcome((alterna+ve(figure)(

154(

Primary(Efficacy(End(Point((RCT)(

155(

Results(–(primary(outcome((CrossFsec+onal) ((

156(

Regression(with(primary(outcomes((CrossFsec+onal(study)(

157(

Results(–(Regression(with(OddsFRa+os(

158(

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(

Discussion(

•  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)(

Purpose:(to(interpret(your(results(and(jus+fy(your(interpreta+on(

Oaen(requires(just(four(or(five(paragraphs(160(

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(

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((((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…(

KEY(RESULTS(

MAIN(CONCLUSIONS(

162(

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(

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(

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(

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(

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(

Abstract(

Purpose:(to(highlight(key(points(from(major(sec+ons(of(the(ar+cle(

Emphasize(what(is(new(and(useful(

Component* Abstracted*from*

Major(purpose(of(study( (((Introduc+on(

Basic(procedures( (((Methods(

Main(findings( (((Results(

Principal(conclusions( (((Discussion(

168(

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.

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.

Synopsis(–(Published(version:(Find(weaknesses(

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.

DECREASE OF MORTALITY OF RECTAL CANCER BY IMPLEMENTATION OF SCREENING FOR BLOOD IN FECES

Structured(Synopsis(

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(

Title(

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(

Purpose:(to(provide(a(brief,(informa+ve(summary(that(will(asract(your(target(audience(

Highlight(what(is(new(and(useful(173(

Title(examples(

Title*•  Longitudinal(evalua6on(of(prostrateY

specific(an6gen(levels(in(men(with(and(

without(prostrate(disease(

o  An(injury(preven+on(program(in(an(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(among(heterosexuals(undergoing(HIV(an+body(tes+ng:(A(randomized(clinical(trial(

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174(

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(

Title * ( ( ( ( ((((((((((((((((((T(((((M((((((R((((((C(((((((N((

(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((

175

Examples(of(+tles:(Your(opinion?(

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

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.*

Title(requirements(

Wri+ng(the(ar+cle(and(submiing(it(to(a(journal(

178(

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(

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(

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(

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(

Conduct(study/analyze(data(

183(

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(

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(

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(

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(

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(

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(

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(

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(

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(

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(

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(

…(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(

How(long?(

•  How(long(should(your(manuscript(be?(

•  Follow(guidance(in(target(journal’s(instruc+ons(for(authors(

•  “Shorter(papers(get(luckier(faster”(

196(

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(

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(

Submit(ar+cle(to(target(journal(

199(

Have(a(Plan(B(

Decide(on(your(next(target(journal(in(case(you(receive(a(rejec+on(

200(

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(

Wri+ng(for(Grant(Proposals(

Eugene(Elbert,(MS((Johns(Hopkins(University,(U.S.A.(

August(2012((

Phases(of(Grant(Wri+ng(

1.  Planning 2.  Preparing 3.  Writing 4.  Submitting

203(

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?

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?(

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(

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(

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(

What(the(customer(wants…(

209(

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.

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(

The(Sec+ons(

211(

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.(

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(

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(

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(

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(