1. Successful(Scien+fic(Wri+ng(
Eugene(Elbert,(MS((Johns(Hopkins((
University,(U.S.)(
Special(thanks(to(:(Paul(Siegel(MD,(MPH(
9F10(August(2012(
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(
(
9. Why(do(we(publish?(
• Presen+ng(research(
• Reaching(global(scien+fic(community(
• Advancing(science(
• Educa+on(
• Funding(and(credibility(
(
11(
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(
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(didn't(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( forensicF
chemical( 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(
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(
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(
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(
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 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(
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(
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(
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(
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(
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(
64. 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(
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+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(
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(Alzheimer's(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(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* 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(
72. 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( (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(
applicable
Data(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(bias
Bias
Explain(how(the(study(size(was(arrived(at
Study(size
(a)(Describe(all(sta+s+cal(methods,(including(those(used(to(
Sta+s+cal(
control(for(confounding
methods (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(
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( 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(
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(
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(
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(
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(
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( 12F
month(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(
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(
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(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(
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(globalF
treatment( 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+entF
reported( 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(
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(
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(
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(
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 matrices
supplemented 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 14
Sheep serum 10.7 (1.4) 10.7 ± 1.4 7
Artificial
10.3 (0.8) 10.3 ± 0.8 3
serum
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
Two*different*styles**of*presen2ng*results**
127(
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 yoblasti
Age, entiated stic cytic ocytic c
eukemia, c
oblastic
years leukemia leukemia leukemia leukemia leukemia leukemia
% 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
129(
129. Formaing(tables,(con+nued(
Table 6. Previous studies of leukocyte reduction during kelvac therapy in patients with
chronic myelogenous leukemia.#
Leukocyte count, %a
No. of
Study Day Day Day Day Day Day Day
patients
0 7 14 21 28 56 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
M9;F7 100 103 95 — 88 69 —
Stenmeyerson, Ref 20
Flowers and Peterson, Ref
M20;F23 100 101 96 93 89 86 98
25
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
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(
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(shortF
term(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(
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(
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(
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,( ageF
related( 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+onF
based( 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(
164. Discussion(F(Recommenda+ons(
Future( research( should( ideally( use( laboratoryF
confirmed( 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(
