phase one manual
TRANSCRIPT
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Manual
CHILDHOOD
ALLERGIESIN
ASTHMAAND
STUDYOF
INTERNATIONAL
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Auckland(NZ) /Mnster(FRG)
December1993(2nd edition)
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INDEX Page
1.0 WhatisISAAC? 31.1 Purpose 31.2 Overviewofstudydesign 31.3 Requirementsforparticipants 42.0 Developmentandadministrationoftheproject 52.1 History 52.2 Organisationalstructure 62.3 Funding 93.0 Scientificbackground 103.1 Asthma 103.2 Rhinitis 113.3 Eczema 113.4 Significanceoftheproposedstudy 124.0 AimsandObjectives 125.0 Methods 135.1 Overview 135.2 Collaboratingcentres 13
5.2.1 Countries 135.2.2 Researchcentres 135.2.3 Investigators 13
5.3 Subjects 145.3.1 Selection 145.3.2 Ethnicgroupandgender 145.3.3 Samplesize 15
5.4 Studydesign 165.4.1 DetailsofPhaseOnecoremodules 165.4.2 PlansforPhaseTwoSupplementaryModules 185.4.3 Seasonofdatacollection 18
5.5 Nonparticipation 195.6 Qualitycontrol 196.0 Datahandlingandanalysis 196.1 Dataqualityandhandling 206.2 Analyses 216.3
Ownershipofdata 21
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Page
7.0 Studyinstruments 227.1 Instructionsforcompletingquestionnaireanddemographicquestions 227.2 Module1.1Corequestionnaireforwheezingandasthma 24
7.2.1 Development,validation 267.3 Module1.2:Corequestionnaireforrhinitis 28
7.3.1 Questionnaires 287.3.2 Development,validation 30
7.4 Module1.3:Corequestionnaireforeczema 317.4.1 Questionnaires 317.4.2 Development,validation 33
7.5 Module1.4:Videoquestionnaire 357.5.1 Questionnaire 357.5.2 Development,validation 36
7.6 Furthercommentsonvalidationofinstruments 377.7 Presentationandtranslation 388.0 Ethicsandconduct 398.1 Ethicalcommitteeapproval 398.2 Modelforapproachingschools 39
8.2.1 Sampleinformationletterfor1314yearolds 398.2.2 Sampleinformationletterfor67yearolds 41
8.3 Modelforapproachingparents 428.3.1 Sample information sheet for parents/guardians of 1314 yearolds 428.3.2 Sampleinformationsheetforparents/guardiansof67yearolds 43
8.4 Guidelinesforfieldworkers 449.0 DataTransfer 4610.0 Contactaddresses 4711.0 Bibliography 51
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1.0 WhatisISAAC?1.1 PurposeThe aetiology of asthma and allergic disease remains poorly understooddespite considerable research. Epidemiology has the potential to add
greatlytoourunderstandingbyelucidatingtheriskfactorsforasthmaand
allergic disease and thereby suggesting productive avenues for research
intocausation.Epidemiologicalstudieshavesofarfailedtoreachtheirfull
potential because of lack of standardisation in casedefinition and
methodologywhichlimitsthevalueofspatialandtemporalcomparisons.
ISAAC,theInternationalStudyofAsthmaandAllergiesinChildhood,was
founded to maximise the value of epidemiological research into asthmaand allergic disease by establishing a standardised methodology and
facilitatinginternationalcollaboration.Itsspecificaimsareto:
1. Describe theprevalenceandseverityofasthma,rhinitisandeczemain children living in different centres and to make comparisons
withinandbetweencountries.
2. Obtain baseline measures for assessment of future trends in theprevalenceandseverityofthesediseases.
3. Provide a framework for further aetiological research into genetic,lifestyle, environmental and medical care factors affecting these
diseases.
1.2 OverviewofstudydesignTheISAACstudydesigncomprisesthreephases.PhaseI isacompulsory
core study designed to assess the prevalence and severity of asthma and
allergic disease in defined populations. Phase II, which has yet to be
developed,will investigatepossibleaetiological factors,particularly those
suggestedbythefindingsofPhaseI.PhaseIIIwillbearepetitionofPhaseI
afteraperiodofthreeyears.
This document is primarily concerned with Phase I. In this Phase each
researchcentreshouldrecruitarandomsampleof3000childrenaged1314
years.Childrenwillbeascertainedthroughschoolclassregistersandasked
tocompletetheISAACcorequestionnairesonasthma,rhinitisandeczema.
Casedefinitions and severity are established by asking about cardinal
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symptoms,notbyreference to labelsordiagnoses(althoughthesewillbe
recorded). It is strongly recommended, but not compulsory, that the
children also complete a video questionnaire on asthma. The video
questionnaire was developed in response to translation problems with
written questionnaires and obviated the need to describe symptoms
verbally.Thevalidityoftheresearchinstrumentshasbeeninvestigated.
It is strongly recommended,but not compulsory, that each centre also
recruitanadditionalsampleof3000childrenaged67years.Childrenwill
be identified through school class registers and their parents asked to
complete the core questionnaires on asthma, rhinitis, and eczema. The
videoquestionnairewillnotbeadministeredtothisagegroup.
It is envisaged that certain research centres may wish to incorporate the
ISAACcoreprotocolintoalargerormorefocusedinvestigationofasthma
and allergy. The ISAAC core protocol has therefore been designed to
accommodate additional questionnaire material and supplementary
investigations.
A detailed description of the scientific background, protocol, and
developmentofinstrumentsisprovidedbelow.
1.3 Requirementsforparticipants1. Prospective research centres must produce a detailed research
protocol showing how the ISAAC Phase I protocol will be
implementedlocally.Keyissuestobeaddressedinclude:themethod
for sampling schools; the geographical definition of the centre; the
approach to ethnic group comparisons if these arebeing made; the
seasonofdatacollection;ifappropriate,methodoftranslatingISAACcore questionnaire into other language(s); evidence that ethical and
othernecessarypermissionshavebeengranted.
2. Eachresearchcentreisresponsibleforobtainingitsownfunding.3. Each centre is responsible for coding and entering its own data. A
copy of the data required for international and interregional
comparisons mustbe made available in suitable electronic form to
theISAACexecutiveforanalysisatthedesignateddatacentre.
4. Each centre may publish its own data without the approval ofISAAC. All publications and communications arising from
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comparisons of more than five international centres require the
approval of ISAAC and will be authored by ISAAC whose
participantswillbeidentified.
We invite the widest possible participation in ISAAC, and welcomeinterested investigators to participate in the development of further
studies. Investigators with research experience in the epidemiology of
asthmaand/orallergicdiseasesareparticularlyencouragedtojoinISAAC.
Research centres able to access distinctive populations (by virtue of their
geography,raceand/orethniccharacteristics)aresimilarlywelcome.
2.0Development
and
administration
of
the
project
2.1 HistoryISAAC emerged from preexisting multinational collaborations regarding
childhoodasthmaepidemiologyincluding:
October 1989 Development of standardised questionnaire formeasuring asthma prevalence in the UK (London), New Zealand
(Auckland),andAustralia(Melbourne).
May 1990 Investigators in Auckland, New Zealand, approachedexperiencedinvestigatorsinfivecountriestoestablishacollaborative
group interested in conducting internationalcomparativestudiesof
asthmaseverityinchildren.
December 1990 An international workshop on monitoring trendsanddeterminantsofasthmaandallergieswasconvenedinBochum,
Germany.InterestedresearchersfromGermany,UK(London),New
Zealand(Wellington),andtheUSAestablishedacollaborativegrouptodevelopastandardisedprotocol.
March1991MergingoftheAucklandandBochuminitiatives. June1991Formationofasteeringcommitteefortheorganisationof
internationalcollaborativestudiesofchildhoodasthmaandallergies.
The countries represented included New Zealand (Auckland,
Wellington),UK(London),andGermany(Bochum).
December 1991 Second international workshop on monitoringtrends and determinants of asthma and allergies was convened in
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Bochum, Germany, to finalise a standard protocol for research.
Presentation of the pilot study involving Wellington, Bochum,
London,SydneyandAdelaide.SteeringCommitteewasextendedto
includeUSA(Tucson).
December 1992 Third International Workshop on InternationalStudyofAsthmaandAllergiesinChildhoodinLondon.
2.2 OrganisationalstructureGeneralapproach
TheorganisationofISAACconsistsoffourlevels:
theSteeringCommittee(includingtheExecutive) regionalcoordinators nationalcoordinators collaboratingcentresThegeneralapproachisthat,inaparticularregion,aregionalcoordinator
is appointed by the steering committee, who then recruits national
coordinators. A regional meeting of national coordinators is held toorganise the implementation of Phase I in the region. The national
coordinatorsthencompletetherecruitmentofcollaboratingcentresintheir
own countries and a national meeting is held prior to the start of data
collection.Thisgeneralapproachisflexible.Forexample,manyEuropean
centreshavealreadystarteddatacollection,orareabouttostart,andsome
instancesanationalmeetinghasalreadybeenheld.
Collaboratingcentres
Theresponsibilitiesofthecollaboratingcentresareto:
completetheregistrationform liaisewiththenationalcoordinator carryoutPhaseIaccordingtotheprotocolinthemanual forwardacleandatasettothenationalcoordinator
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Nationalcoordinators
The national coordinators are generally responsible for a single country.
However, in some instances they maybe responsible for several small
neighbouring countries, particularly if these only have one collaboratingcentreand/orifnosuitablenationalcoordinatorsareavailable.
Theresponsibilitiesofthenationalcoordinatorsareto:
recruitandregistercollaboratingcentres organise translation and production of the Phase I manual and
questionnaires
organise a national meeting of collaborating centres to organise theimplementationofPhaseI liaise with the collaborating centres and provide assistance when
required,includingcleaningofthedata
liaisewiththeregionalcoordinators check and forward the clean national data sets to the regional
coordinators
organiseafurthernationalmeetingofcollaboratingcentrestodiscusstheresultsofPhaseI
Regionalcoordinators
Theregionalcoordinatorsareresponsibleforabroadregionoftheworld.
TheregionswillgenerallybebasedonthesixWHOregionsoftheworld,
since these are widely used and logically organised. However, in some
instances a WHO region maybe split into subregions, if the number ofcollaboratingcentresorcountriesislarge.
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TheISAACregionsarecurrentlyasfollows:
WHOregion ISAACregion
Europe WesternEurope
EasternEurope/Baltics
Americas NorthAmerica
LatinAmerica
Africa Africa
SouthEastAsia SouthEastAsia
WesternPacific AsiaPacific
Oceania
EasternMediterranean EasternMediterranean
Theresponsibilitiesoftheregionalcoordinatorsareto:
recruitnationalcoordinators help national coordinators with translation and production of the
PhaseImanualandquestionnaires,andapprovalofthefinalversion
beforeuse
organise a meeting of national coordinators to organise theimplementation of Phase I (prior to the national meetings specified
above)
assistwithnationalmeetings liaise with national coordinators and provide assistance when
required, including official feedback from the Steering Committee,
andcheckingofnationaldatasets
liaisewiththeSteeringCommittee,andparticipateinmeetingsoftheExtendedSteeringCommittee
organise a further meeting of national coordinators to discuss theresultsofPhaseIandtoplanPhaseII
TheSteeringCommittee
TheSteeringCommitteehasrecentlybeenexpandedandnowincludesthe
Regional Coordinators, and the Module Leaders (of the various Phase II
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modulesthatareunderdevelopment),inadditiontotheoriginalmembers
oftheSteeringCommittee.
TheresponsibilitiesoftheSteeringCommitteeare:
recruitregionalcoordinators assistwiththeregionalmeetings liaise with regional coordinators and provide assistance when
required
coordinatetheimplementationandconductofPhaseI organisethefurtherdevelopmentofmodulesandmethodsforPhase
II coordinatetheanalysesandpublicationsofdata organisefutureinternationalISAACmeetingsThefullSteeringCommitteewillmeetannually.
TheExecutive
TheISAACstudyiscoordinatedonadaytodaybasisbyathreemember
executive.Thecurrentexecutiveconsistsof:
Dr.InnesAsher(DataCoordination) Prof.RichardBeasley(ImplementationofPhaseI) Dr.DavidStrachan(MethodsDevelopment)TheExecutiveischairedbyDr.Asher.
2.3 FundingEach research centre is responsible for obtaining its own funding. At the
time of writing, funding hasbeen successfully obtained from the Health
ResearchCouncilofNewZealandforthreeNewZealandcentres,fromthe
LocallyOrganisedResearchFundoftheDepartmentofHealthinEngland
foroneEnglishcentre,andfromtheMinistryforWork,HealthandSocial
Affairs of the German State of North RhineWestphalia for one German
centre.InFrancethreecentresobtainedcompleteandanotherthreecentresobtained partial funding. In Italy two centres are funded and in Spain
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fundinghasbeenobtainedforfourcentres.Fundingsupportisexpectedto
beobtainedinthenearfutureforanumberofothercentres.
3.0 ScientificbackgroundThere is considerable concern regarding a possible increase in the
prevalenceandincidenceofasthmaandallergiesinWesterncountries.
3.1 AsthmaAsthma isoneof themost importantdiseasesofchildhood indeveloped
countries.Estimatesofthe12monthperiodprevalenceofparentreported
wheezing illnessvarygreatlybutrangefrom1015% in theUK to30% inAustralasiaandamongstthese,theproportionwithadiagnosisofasthma
ranges from 3070%. About one third of those affected by asthma
experiencerestrictionofactivitiesandlossofschool.Antiasthmaticdrugs
are the most frequently used prescribed therapy in childhood. There is
evidencethattheprevalenceandseverityofasthmaisincreasing.Hospital
admissionshave increasedtoagreaterdegree inmanycountriesand this
hasbeen attributedboth to changes in medical practice and changes in
prevalence.Anumberofcountriesexperiencedepidemicsofmortality inthe1960sandsubsequentlyafurtherepidemicoccurredinNewZealand.
Atnationalandtoalesserextentsubnationalleveltherearegeographical
variations in prevalence, mortality and hospitaladmissions. The cause of
these regional variations is unknown. It is known that genetic factors
predispose to asthma and other atopic disorders but migrant studies
indicate that the reasons for regional variations are environmental rather
thangenetic.Anenvironmental factormightacteitherbyinducing theasthmatictendencyinageneticallysusceptibleindividualorbyinciting
attacks in individualswhohavebecomeasthmatic.Little isknownabout
inducing factors and while something is known about inciting factors
(infection, allergens, inhaled irritants, emotion, exercise), their role in
explaining regional differences is obscure. There is general concern that
factorsassociatedwithmodernlifestyleandenvironment(e.g.airpollution
ordiet)mayberesponsiblebutevidenceismeagre.Afurthercomplication
is the possibility that some forms of treatment might themselves beincreasingmortalityandmorbidity.
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3.2 RhinitisThere are no widely agreed criteria for the diagnosis or classification of
noninfectious rhinitis. The principle symptoms of noninfectious rhinitis
aresneezing,runningnose(rhinorrhea),and/ornasalblockage.Patientsaregenerallyclassifiedaccordingtothesuspectedaetiologyoftheircondition
into allergic and nonallergic types. Rhinitis is labelled allergic when a
causativeallergencanbeidentified.Otherwiseitislabellednonallergic.
Thisapproachtoclassification isproblematic inthat it is impossible tobe
certain that a nonallergic subject would not prove reactive to some
allergenyettobeexamined.
Surprisinglylittleisknownabouttheprevalenceordistributionofrhinitis.Veryfewstudieshaveusedstandardisedcasedefinitionsandthemajority
havefocusedonhayfever(seasonalallergicrhinitis)leavingotherformsof
the condition unstudied. The estimated prevalence of hay fever among
schoolchildrenindifferentcountrieshasbeenreportedtovarybetween0.5
and 28%. There is also evidence the prevalence of hay fever may vary
between different geographical regions within countries. Britain, Sweden
and the United States have reported increases in the prevalence of
diagnosed hay fever in recent decades. Possible explanations fordifferencesinprevalenceovertimeandbetweenplaces,includedifferences
in the diagnostic criteria of doctors, differences in patients consulting
behaviour, and differences in putative environmental provoking factors
(e.g.aeroallergenburden,airpollution).
3.3 EczemaLittle is known about the epidemiology of eczema or atopic dermatitis.
However, geographical variations in prevalence havebeen described in
Britain and these closely match regional variations in hayfever. This
suggests withincountry variation in the underlying atopic tendency.
Comparisons over time in Britain and Denmark have suggested that
eczema (as reported by parents) is more common among more recent
generationsofchildren.
In theory,eczema ismorereadilyconfirmedbyobjective tests thaneither
asthma or rhinitis. However, there are currently no internationallyaccepted criteria for definition of atopic dermatitis. A list of major and
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minor criteria proposed by Hanifin and Rajka in the 1970s have been
furtherevaluatedandwidelyappliedinclinicalstudiesbuthavenotbeen
definedandstandardisedinamannersuitableforepidemiologicalstudies.
A teamofBritishdermatologistsarecurrentlydevelopingandvalidating
definitions of atopic dermatitis based on questionnaire data with or
withoutclinicalsigns.The former,whichcorrespondclosely to themajor
criteria proposedby Hanifin and Rajka, havebeen incorporated into the
initialphaseofthepresentstudy.
3.4 SignificanceoftheproposedstudyMuchresearchhasbeenconductedintothereasonswhysomeindividuals
rather than others develop asthma and other atopic diseases such asrhinitis and eczema. The main finding hasbeen that a family history of
atopic disease is a major risk factor. Environmental factors nevertheless
remainimportantintheexpressionofdiseasebutstudiesatanindividual
level have had rather limited value in identifying what those factors are.
Another approach is to investigate why the level of disease varies from
population to population. Factors affecting the prevalence of disease ata
populationlevelmaybedifferent.Indeedtherearesomefactorswhichcan
only be studied in this way because whole populations may be fairlyevenlyexposedtothefactor,thusprecludingepidemiologicalstudywithin
the population. There is little firm evidence concerning the reasons for
trends in atopic disease (and of atopic status per se) within populations.
Oneobstacletotheinvestigationofpopulationdifferences(andoftrends)
hasbeenthelackofasuitableandgenerallyacceptedmethodofmeasuring
the prevalence and severity of asthma and other atopic diseases in
children.Theotherobstaclehasbeentheabsenceofacoordinatedresearch
programmetoobtainandanalysecomparativedata.TheISAACstudyhasbeendevelopedtoaddressthesequestions.
4.0 AimsandObjectives1. To describe the prevalence and severity of asthma, rhinitis and
eczema in children living in different centres and to make
comparisonswithinandbetweencountries.
2. To obtainbaseline measures for assessment of future trends in theprevalenceandseverityofthesediseases.
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3. To provide a framework for further aetiological research intolifestyle, environmental, genetic and medical care factors affecting
thesediseases.
5.0 Methods5.1 OverviewThecollaborativestudieswillbeconducted inthreephases.PhaseI isthe
corestudydescribedindetailhere.PhaseIIinvolvesmoredetailedstudies
of aetiological factors and clinical examination of subgroups of children.
PhaseIIIwillbearepetitionofPhaseIafterthreeyears.
5.2 Collaboratingcentres5.2.1 CountriesThiswillbeamulticentrestudy, involvingasmanycentresandcountries
as wish to collaborate who can meet the requirements of the study
protocol. It is hoped that many countries will have at least two centres
participating to enable a within country comparison as well asbetween
countrycomparisons.
5.2.2 ResearchcentresAn ISAAC research centre is a distinctive population in terms of its
geography, race and/or ethnic characteristics, where one or more named
investigatorshaveagreedtofollowtheISAACstudyprotocoldescribedin
thismanual.Whereexistingdatasuggestregionaldifferencesinasthmaor
allergicdiseases,participationof thesecentreswillbeofparticularvalue.Thesampleofchildren takingpart in ISAACshouldnotpreviouslyhave
been recruited systematically for research into asthma or allergies
(although individual children may have been so involved). However,
investigators may wish to use ISAAC as the first stage in new local
researchabouttheseconditions.
5.2.3 InvestigatorsInvestigators who have experience with asthma or its epidemiology,especiallyinchildren,areparticularlyencouragedtojoinISAAC.
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5.3 Subjects5.3.1 SelectionThepopulationof interest is school childrenwithina given geographicalarea.Arandomsampleoftwoagegroupsofchildrenwillbestudied:1314
yearoldsand67yearolds.Thesamplingunitwillbeaschoolforeachage
group. Each school in the centre which would contain the age group of
interestwillbeallocatedanumber,andtheschoolswillbeselectedusinga
table of random numbers. Sampling of each age group willbe separate.
Once a school hasbeen chosen, two school years willbe chosen which
includethosewiththegreatestproportionof13yearoldsand14yearolds;
those with the greatest proportion of 6 year olds, and 7 year olds. It isrecognisedthattherewillbesomechildrenoutsidethespecifiedageranges
ineachclasschosen.Thesechildrenmaybeincludedinthedatacollection,
butwillbeexcludedfromanalysisfortheinternationalcomparison.
The younger age group hasbeen chosen to give a reflection of the early
childhood years, when asthma is common, and admission rates are
particularly high. However some centres may not have the resources to
proceedwiththeyoungeragegroup.Theolderagegrouphasbeenchosentoreflecttheperiodwhenmortalityfromasthmaismorecommon.School
childrenarethemostaccessiblepeopleofanyagegroup.
A minimum of 10 schools (or all the schools) per centre are needed to
obtain a representative sample. If a selected school refuses participation,
thentheschoolwillbereplacedbyanotherchosenatrandom.Noeligible
childrenwillbeexcludedfromthesample.
Ifaschool fordisabledchildren (e.g.blind, intellectuallyhandicapped) ischosen, theywillbestudied.However it isacknowledged that theremay
beadisproportionatenumberofchildrenofthe1314yearagegroupwho
are unable to participate in such a school. This wouldbe one reason for
nonparticipation.
5.3.2 EthnicgroupandgenderWhere comparisonsbetween ethnic groups are planned, the question on
ethnicityshouldpreferably follow thatused in themostrecentCensusof
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Populations in the individual centre. There willbe a question to identify
thegenderofthechild.
5.3.3 SamplesizeThe aim is to detect differences, if they exist, which are meaningful
clinically,epidemiologically,economicallyandforhealthservicedelivery.
The sample size required to detect differences in severity of asthma is
higher than that required to detect the same magnitude in differences in
prevalenceofasthmabecausesevereasthma is lesscommon.Thesample
size estimates are stringentbecause of the number of hypothesesbeing
tested and the need tobe certain of the results in such a major study. A
samplesizeof3000hasbeenchosen,whichgivesthefollowingpower:1. PrevalenceofwheezingIfthetrueoneyearprevalenceofwheezingis30%inonecentreand25%in
anothercentre,withasamplesizeof3000, thestudypower todetect this
differencewillbe99%atthe1%levelofsignificance.
2. SeverityofwheezingIfthetrueoneyearprevalenceofsevereasthmais5%inonecentreand3%
inanothercentrewithasamplesizeof3000thestudypowertodetectthisdifferencewillbe90%atthe1%levelofsignificance.
It is recognised that some centres may have limited resources or
populationsbut it isneverthelessdesirablefor themtobe included in the
prevalence comparisons. Centres with sample sizes in the range of 1000
2999 will only be included in the prevalence comparisons but not the
severity comparisons. This summary table of sample size and power
considerations shows the effect of changing sample size on the power of
detectingdifferencesintheprevalenceofasthma:
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Samplesizeandpowerconsiderations
Table1a
PrevalenceoftroublesomeasthmaPOWER(%)
(significancelevel1%)
Differencebeingtested
Samplesize 5%v3% 5.5%v3% 6%v3% 6%v4%
3000 90 98 99 82
2500 83 95 99 72
2000 71 89 97 60
1500 55 70 90 44
1000 34 53 71 26
Table1b
Severityofsleepdisturbanceduetowheezing
Samplesize
(significancelevel1%)
Differencebeingtested
(%populationwhoareinadifferentresponse
category,e.g.neverwokenwithwheeze,wokenlessthanonenightperweek)
Power(%) 20% 25% 30%
90 3000 2100 1500
80 2500 1700 1200
70 2150 1400 1000
60 1800 1200 900
5.4 Studydesign5.4.1 DetailsofPhaseOnecoremodulesThree one page questionnaires have been developed by the current
collaborators. These were agreed for use at the International Study of
AsthmaandAllergiesinChildhoodataworkshopinBochum,Germany,8
10 December 1991. The aim of compiling a core questionnaire is to
ensure that comparable information on the basic epidemiology ofwheezing illness and its diagnosis is obtained from as many surveys as
possible. The exact wording of questions follows, as far as possible,
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questions which havebeen used on published questionnaires and which
havefounddifferencesbetweenpopulations.
Itisanticipatedthatindividualinvestigatorsmaywishtosupplementthem
with questions of their own, but they should endeavour to retain thegeneral form of the questionnaire, including the flow and stemming, as
indicated.Anyadditionalquestionsshouldcomeattheendofthefourcore
modules. Consideration must be given to the effect this may have on
participation.
In Section 7, the core questionnaires are presented, along with a
commentaryabout theirdevelopmentandvalidation.The1314yearolds
willbepresentedwiththewrittenquestionnairesonwheezing,rhinitisandeczema, and if feasible, the video questionnaire. Investigators are also
encouraged to recruit the sample of 67 year olds, whose parents willbe
asked to complete the appropriate written questionnaires on wheezing,
rhinitisandeczema.Thefollowingoutlinesummarisesthisdesign:
PhaseIModules 1314years 67years
1.1Corequest.onwheezing compulsory stronglyrecommended
1.2Corequest.onrhinitis compulsory stronglyrecommended
1.3Corequest.oneczema compulsory stronglyrecommended
1.4Videoquest.onwheezing stronglyrecommended notused
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5.4.2 PlansforPhaseTwoSupplementaryModulesThe December 1992 London meeting established working groups with a
coordinator to develop the instruments for Phase II. This manual covers
only Phase I,but collaborators are invited to contribute to the design ofPhaseIIinstruments.Itisenvisagedthattherewillbeatleastthefollowing
modules:
Module2.1: Management medications
healthservicedelivery
Module2.2: Indoorenvironmentalriskfactors
physicalconditionschemicalirritants
allergens
Module2.3: Otherrespiratorysymptoms
Module2.4: Bronchialresponsivenesstesting
Module2.5: Skintestsforatopy
Module2.6: SerumIgE
Module2.7: Physicalexamination
Developmentofthesemoduleswillincludepilotstudiesinsomecentres.
It is anticipated that there willbe future phases of the study, probably
including the following: repeat prevalence and severity studies; cohort
followupstudies;casecontrolstudies.
5.4.3 SeasonofdatacollectionIt is recognised that the season of the year may influence the reported
prevalence of symptoms of rhinitis or eczema. However there is little
evidence that the reported one year prevalence of symptoms of asthma
varies over seasons from studies which have included Autumn, Winter,andSpring.Analysisofdata inadults(Wellington,NewZealand),young
adults (London, United Kingdom) and in children (Munich, Federal
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Republic of Germany) shows no significant monthly variation in the
reported one year prevalence. The date of data collection must be
documented and at least half of the study population should be
investigatedbeforethemainpollenseasonofthestudyarea.
5.5 NonparticipationA participation rate of at least 90% willbe sought. It is a concern that
absentchildrenmaybeaway fromschoolbecauseofasthmaorallergies.
Thereforestrenuouseffortsneedtobemadetocontactthesechildrenand
offer theopportunityofparticipation in thestudy. In thecaseofchildren
whereconsenthasbeenrefused,demographicdata(age,sex,ethnicgroup)
fromtheschoolwillbesought.
In the case of the younger age group, if the initial questionnaire is not
returnedwithinoneweek,theinformationletterandquestionnairewillbe
sentagain.
5.6 QualitycontrolThereisparticularimportanceattachedtothequalityofthedatacollection
andprocedures in ISAAC,so that therewillbeconfidence in the results.Prospective research centres must produce a detailed research protocol
showinghowtheISAACPhaseIprotocolwillbeimplementedlocally.Key
issues to be addressed include: the method for sampling schools; the
geographical definition of the centre; the approach to ethnic group
comparisons if these are being made; the season of data collection; if
appropriate, method of translating ISAAC core questionnaire into other
language(s); evidence that ethical and other necessary permissions have
been granted. In addition, a statement shouldbe included indicating theintenttoachieveahighparticipationrateandnomorethan5%ofthedata
missingfromthecompletedquestionnaireforms.
6.0 DatahandlingandanalysisEachgroupofsubjectswillbetreatedseparately:67yearolds,1314year
olds,andsubjectsofeachethnicgroupwhereamajorcomparisonisbeing
made (sample size 3000 for each ethnic group). Each parameter of
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prevalence and severity willbe comparedbetween locations. The cluster
effectisnotexpectedtobegreat,butwillbeadjustedforintheanalysis.
6.1 DataqualityandhandlingThe completed questionnaire must not be changed under any
circumstances.Datashouldbeenteredonthecomputerexactlyasrecorded
on the completed questionnaire. Any changes to data entered shouldbe
doneso foranexplicitreasonanddocumented.Thosechangesshouldbe
madetoacopyoftheoriginalcomputerdatafile.
Ifquestions1and2arenotcompletedinthewheezingquestionnaire,that
questionnairewillbeexcludedfromanalysis,butallavailabledatashould
stillbeenteredonthecomputer.Acodingmanualisnecessarysothatthe
corequestionswillbecodedinastandardmanner(seeSection9).
Ascheme tohandleblankor inconsistentstemandbranchquestionswill
bedevelopedsothatasingledenominatorforprevalencecanbeused.This
willassumethatparentsofsymptomaticchildrenwillbeunlikelytoleave
questionsblankand that thecategoryin the last12months inabranch
questionoverridesanegativeorblankstem.Arangecheckwillbeusedto
identifyanyotherinconsistency.
Each centre willbe responsible for coding its own data and data entry,
although insomeregions/countriesonecentremaytakeresponsibilityfor
this. One Data Centre willbe chosen for the international comparison of
the core data set. Data willbe sent to the Data Centre as ASCII files in
standard format, detailed in the coding manual; data on disks will be
returned to each centre for their own use. A copy of data required for
internationalcomparisonswillberetained in theDataCentreforanalysisalongwithdatareceivedfromtheothercentres.Datawillbeenteredona
PCwiththerequisitecapacityandmemory,interfacingwithamainframe
for more complex analyses. The results of data analyses will be
communicated to theothercentresas information isproduced,and input
on the data analyses will be sought from the other collaborators.
Collaborators are encouraged to visit the Data Centre and work with its
staffoncollaborativeanalyses.
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6.2 AnalysesThe objective of the study is to describe the prevalence and severity of
asthma, rhinitis and eczema in children living in different centres and to
makecomparisonswithinandbetweencountries(Seesection4,Part1).
Basicdescriptivesummariesofthedatawillbecompiledandpresentedin
an ISAAC Data Book. This Data Book willbe thebasic reference for the
wholestudyandwilldescribeprevalenceandseverityofasthma,rhinitis
and eczema in both age groups for males and females in each of the
countriesparticipating.
Comparisonsbetweendifferentcentresontheratesofeventswillbemade
usingmethodsappropriate to thesituation.Cruderatescanbecompared
by using contingency tables or logistic regression. Comparison of
standardized rates or data that needs controlling for confounding will
require analysisby suitable multivariate methods (most probably logistic
regression).
The ancillary questions willbe treated in the same manner as the major
questions on prevalence and severity. Summaries for each centre willbe
recordedintheDataBookandcomparisonsmadeappropriately.
Datawillbeanalysedwithineachcountry(andcentre if largeenough)as
wellasthe internationalcomparisons.Thiswillallowfortheintroduction
ofadditionalvariablesthatthecountrymayhaveincorporated.
Seasonality, methods of survey sampling, age standardisation and any
otherissueswillbeconsideredintheanalysisoftheISAACdata.
6.3 OwnershipofdataEachcentreowns theirowndata.However, thecollaboratingcentreswill
be recognised by the group title International Study of Asthma and
Allergies in Childhood (ISAAC). All publications and communications
involvinginternationalcomparisonswillbeauthoredbytheISAACStudy
Groupwhosecollaboratorswillbeidentified.
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7.0 StudyinstrumentsThecontentofthequestionnaireswhichappearbelowisfixed.Seesection
7.1forfurthercomments.
7.1 Instructions for completing questionnaire and demographicquestions
Examplesof instructions for completingquestionnairesanddemographic
questionsaregivenbelow.
13and14yearolds
On this sheet are questions about your name, school, and birth dates.Pleasewriteyouranswerstothesequestionsinthespaceprovided.
Allotherquestionsrequireyoutotickyouranswerinabox.Ifyoumakea
mistakeputacross in theboxand tick thecorrectanswer.Tickonlyone
optionunlessotherwiseinstructed.
Exampl es of how t o mark quest i onnai r es: Age
years
13
YES NO
SCHOOL:
TODAY' S DATE:
Day Mont h Year
YOUR NAME:
YOUR AGE:
years
YOUR DATE OF BI RTH:
Day Mont h Year
( Ti ck al l your answer s f or t he r est of t he quest i onnai r e)
Ar e you: MALE FEMALE
Opt i onal quest i ons on et hni ci t y her e
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6and7yearolds
On this sheet are questions about your childs name, school, andbirth
dates.Pleasewriteyouranswerstothesequestionsinthespaceprovided.
Allotherquestionsrequireyoutotickyouranswerinabox.Ifyoumakea
mistakeputacross in theboxand tick thecorrectanswer.Tickonlyone
optionunlessotherwiseinstructed.
Exampl es of how t o mark quest i onnai r es: Age
years
6
YES NO
SCHOOL:
TODAY' S DATE:
Day Mont h Year
CHI LD S NAME:
CHI LD S AGE:
years
CHI LD SDATE OF BI RTH:
Day Mont h Year
( Ti ck al l your answer s f or t he r est of t he quest i onnai r e)
I s your chi l d a: BOY GI RL
Opt i onal quest i ons on et hni ci t y her e
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7.2 Module1.1 CorequestionnaireforwheezingandasthmaQuestionnairefor13and14yearolds
1
Haveyou
ever
had
wheezing
Yes
orwhistlinginthechest
atanytimeinthepast? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
2 Haveyouhadwheezingor Yes
whistlinginthechest
inthelast12months? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
3 Howmanyattacksofwheezing None
haveyouhad 1to3
inthelast12months? 4to12
Morethan12
4 Inthelast12months,howoften,onaverage,has
yoursleepbeendisturbedduetowheezing?
NeverwokenwithwheezingLessthanonenightperweek
Oneormorenightsperweek
5 Inthelast12months,haswheezing Yes
everbeensevereenoughtolimityour
speechtoonlyoneortwo No
wordsatatimebetweenbreaths?
6 Haveyoueverhadasthma? Yes
No
7 Inthelast12months,hasyour Yes
chestsoundedwheezy
duringorafterexercise? No
8 Inthelast12months,haveyou Yes
hadadrycoughatnight,
apartfromacoughassociatedwith No
acoldorchestinfection?
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Questionnairefor6and7yearolds
1 Hasyourchildeverhadwheezing Yes
orwhistlinginthechest
atanytimeinthepast? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
2 Hasyourchildhadwheezingor Yes
whistlinginthechest
inthelast12months? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
3 Howmanyattacksofwheezing None
hasyourchildhad 1to3
inthelast12months? 4to12
Morethan12
4 Inthelast12months,howoften,onaverage,has
yourchildssleepbeendisturbedduetowheezing?
Neverwokenwithwheezing
Lessthanonenightperweek
Oneormorenightsperweek
5 Inthelast12months,haswheezing Yes
everbeensevereenoughtolimityour
childsspeechtoonlyoneortwo No
wordsatatimebetweenbreaths?
6 Hasyourchildeverhadasthma? Yes
No
7 Inthelast12months,hasyour Yeschildschestsoundedwheezy
duringorafterexercise? No
8 Inthelast12months,hasyour Yes
childhadadrycoughatnight,
apartfromacoughassociatedwith No
acoldorchestinfection?
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7.2.1 Development,validationThese questions are designed as a minimum set for inclusion in self
completed or interviewadministered questionnaires used in population
surveys of respiratory disease in children. Note that enquiry aboutsymptomsproceeds from the relatively mild to the relatively severe,and
precedesenquiryaboutdiagnosis.
These questions (selfcomplete version) were included in a pilot study
conductedamong8,0001314yearoldsinfourcentresduring1991.
Thejustificationfortheindividualquestionsisasfollows:
Qu.1. ThisisbasedontheIUATLDquestionnaire.Itdoesnotmentionattacks of wheezing, in order to identify children with
persistentsymptomswhicharenotobviouslycharacterisedas
episodesorattacks.Thisisseenasaverysensitivequestion.
Qu.2. Limitationtoa12monthperiodreduceserrorsofrecalland(at
leastintheory)shouldbeindependentofmonthofcompletion.
This isconsidered tobe themostusefulquestionforassessing
theprevalenceofwheezingillness.
Qus.3,4. Thesequestionsoffer twoalternativequantitativemeasuresof
the frequency of wheezing. Problems with the concept of
attacks (seeabove)anddifficulty inquantifying the frequency
of recurrent asthma lead to the inclusion of question 4 to
identifyandquantifypersistentwheeze.
Qu.5. There is a dearth of epidemiological information relating to
acute severe asthma, which is of direct relevance for
internationalcomparisonsofhospitaladmissionsandmortality
statistics.Thisquestionaimstofillthisgap.
Qu.6. All respondents are asked about diagnosed asthma, as
occasionally asthma may be diagnosed in the absence of
wheeze(onthebasisofrecurrentnocturnalcoughetc.).
Qu.7. Although logically this question belongs as a stem questionundernumber2 (where it wasused in thepilotstudy), ithas
been found in certain Australasian surveys to identify some
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children who deny (or whose parents deny) wheezing or
whistlingatquestion1or2.
Qu.8. Nocturnal cough is widely accepted as an alternative
presentationofasthma,andthisquestionhasbeenincludedtoincreasetheoverallsensitivityofthequestionnaire,althoughits
specificityinpopulationsurveysremainsunclear.
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7.3 Module1.2: Corequestionnaireforrhinitis7.3.1 QuestionnairesQuestionnairefor13and14yearoldsAllquestionsareaboutproblemswhichoccurwhenyouDONOThaveacoldor the
flu.
1 Haveyoueverhadaproblemwithsneezing, Yes
orarunny,orblockednosewhenyou
DIDNOThaveacoldortheflu? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
2 Inthepast12months,haveyouhadaproblem Yes
withsneezing,orarunny,orblockednose
whenyouDIDNOThaveacoldortheflu? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
3 Inthepast12months,hasthisnoseproblem Yes
beenaccompaniedbyitchywateryeyes? No
4
Inwhich
of
the
past
12
months
did
this
noseproblemoccur?(Pleasetickanywhichapply)
January May September
February June October
March July November
April August December
5 Inthepast12months,howmuchdidthisnose
probleminterferewithyourdailyactivities?:
Notatall
Alittle
Amoderateamount
Alot
6 Haveyoueverhadhayfever? Yes
No
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Questionnairefor6and7yearolds
1 Haveyourchildeverhadaproblemwithsneezing, Yes
orarunny,orblockednosewhenhe/she
DIDNOThaveacoldortheflu? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
2 Inthepast12months,hasyourchildhadaproblem Yes
withsneezing,orarunny,orblockednose
whenhe/sheDIDNOThaveacoldortheflu? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
3 Inthepast12months,hasthisnoseproblem Yes
beenaccompaniedbyitchywateryeyes? No
4 Inwhichofthepast12monthsdidthis
noseproblemoccur?(Pleasetickanywhichapply)
January May September
February June October
March July November
April August December
5 Inthepast12months,howmuchdidthisnoseproblem
interferewithyourchildsdailyactivities?:
Notatall
Alittle
Amoderateamount
Alot
6 Hasyourchildeverhadhayfever? Yes
No
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7.3.2 Development,validationTheprincipalaimsareto:(1)distinguishbetweenrhiniticandnonrhinitic
individuals in the general population; (2) predict which subjects with
rhinitisarelikelytobeatopic;and(3)givesomeindicationoftheseverityofrhinitisamongaffectedindividuals.
Thejustificationforindividualquestionsisasfollows:
Qu.1. Thisquestionwasfoundtohaveapositivepredictivevalueof
80%indetectingrhinitisinacommunitysampleofadults(aged
1665years)insouthwestLondon.
Qu.2. Asfor1above.
Qu.3. Thissymptomhad thehighestpositivepredictivevalue (78%)
indetectingatopyamongsubjectswithrhinitis.
Qu.4. Thisquestionpermitssubjectswithrhinitistobeseparatedinto
thosewithseasonalsymptomsaloneandthosewithaperennial
problem. The method maximises precision in classification, is
devoidofsubjectivedefinitionsofseason,andcouldbeused
byanycountryregardlessofclimate.Thenumberofmonthsa
subject isaffectedcouldbeusedasaquantitative indicatorof
severity. Seasonal exacerbations had a positive predictive
valueof71%indetectingatopyamongsubjectswithrhinitis.
Qu.5. While this is a crude qualitative measure of severity, it
correlated well with other indicators of morbidity including
reportedsymptomseverity,interferencewithspecificactivities
ofdailylivingandmedicalserviceuse.
Qu.6. Thisquestionpermitsinvestigationofthelabellingofrhinitisin
relation to the prevalence of rhinitic symptoms. The label
hayfeverhadapositivepredictivevalueof71% indetecting
atopyamongsubjectswithrhinitis.
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7.4 Module1.3: Corequestionnaireforeczema7.4.1 QuestionnairesQuestionnairefor13and14yearolds1 Haveyoueverhad Yes
anitchyrashwhichwascomingand
goingforatleastsixmonths? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
2 Haveyouhadthisitchy Yes
rashatanytimeinthelast12months? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
3 Hasthisitchyrashatanytimeaffected Yes
anyofthefollowingplaces: No
thefoldsoftheelbows,behindtheknees,
infrontoftheankles,underthebuttocks,
oraroundtheneck,earsoreyes?
4
Hasthis
rash
cleared
completely
at
any
time
Yes
duringthelast12months? No
5 Inthelast12months,howoften,onaverage,haveyou
beenkeptawakeatnightbythisitchyrash?
Neverinthelast12months
Lessthanonenightperweek
Oneormorenightsperweek
6 Haveyoueverhadeczema? YesNo
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Questionnairefor6and7yearolds
1 Hasyourchildeverhad Yes
anitchyrashwhichwascomingand
goingforatleastsixmonths? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
2 Hasyourchildhadthisitchy Yes
rashatanytimeinthelast12months? No
IFYOUHAVEANSWEREDNOPLEASESKIPTOQUESTION6
3 Hasthisitchyrashatanytimeaffected Yes
anyofthefollowingplaces: No
thefoldsoftheelbows,behindtheknees,
infrontoftheankles,underthebuttocks,
oraroundtheneck,earsoreyes?
4 Atwhatagedidthis Under2years
itchyrashfirstoccur? Age24years
Age5ormore
5 Hasthisrashclearedcompletelyatanytime Yes
duringthelast12months? No
6 Inthelast12months,howoften,onaverage,has
yourchildbeenkeptawakeatnightbythisitchyrash?
Neverinthelast12months
Lessthanonenightperweek
Oneormorenightsperweek
7 Hasyourchildeverhadeczema? Yes
No
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7.4.2 Development,validationThese questions are designed as a minimum set for inclusion in self
completed or interviewadministered questionnaires used in population
surveysofallergicorskindiseaseinchildren.
Itisanticipatedthatindividualinvestigatorsmaywishtosupplementthem
with questions of their own, but they should endeavour to retain the
general form of the questionnaire, including the flow and stemming, as
indicated.Notethatenquiryaboutsymptomsproceedsfromtherelatively
mildtotherelativelysevere,andprecedesenquiryaboutdiagnosis.
Thejustificationfortheindividualquestionsisasfollows:
The numbering refers to the version for completion by parents. The
questiononageatonsethasbeenexcludedfromtheselfreportedversion
becauserecallofrashesininfancybychildrenintheirteensislikelytobe
incomplete.
Qu.1. This screening question was evaluated in a UK pilot study of
factors which discriminated typical mildmoderate atopic
dermatitis from nonatopic eczema and other inflammatorydermatoses presenting for the first time in British hospital
outpatient clinics. A positive response to this question was
obtainedforall36casesofatopicdermatitispresentingatages
519 years, and 91% of 120 cases of all ages. Taken alone,
however,ithadspecificityofonly44%atages519and48%at
allages.
Qu.2. Followingtheformofthecorequestionnairesforwheezingandrhinitis, further enquiry focuses only on those children with
recentrashes,tominimiseproblemsofincompleteandselective
recall.
Qus.3,4. IntheUKstudy,thespecificity(i.e.thepowertoexcludenon
atopic forms of eczema and other inflammatory dermatoses)
was improved substantially by considering flexural
involvementandageatonset.Inthe519agegroup(basedon
36 cases of atopic dermatitis and 27 control subjects) the
sensitivitywas94%andspecificity81%ifflexuralinvolvement
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alonewereincluded,andsensitivity92%withspecificity96%if
casedefinition was based on both flexural involvement and
onsetbefore5yearsofage.
Qus.5,6. These two questions havebeen included as measures of theseverity of the dermatitis, one assessing chronicity, the other
morbidity. A question on the extent of skin involvement was
considered and rejected as infeasible for questionnairebased
studies.
Qu.7. This question may need tobe modified slightly in countries
where a number of diagnostic labels are in common use (e.g.
Has your child ever had any of the following: ...?). Asupplementarystemquestion (Ifyes,was thisdiagnosedbya
doctor?)wasconsideredoptional.
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7.5 Module1.4: Videoquestionnaire7.5.1 Questionnaire1.
Has
your
breathing
ever
been
like
this?:
atanytimeinyourlife? YES NO
ifYES,:inthelastyear? YES NO
ifYES,:oneormoretimesamonth? YES NO
2. Hasyourbreathingbeenlikethegirlsinthevideofollowingexercise?
atanytimeinyourlife? YES NO
ifYES,:inthelastyear? YES NO
ifYES,:oneormoretimesamonth? YES NO
3. Haveyoubeenwokenlikethisatnight?:atanytimeinyourlife? YES NO
ifYES,:inthelastyear? YES NO
ifYES,:oneormoretimesamonth? YES NO
4. Haveyoubeenwokenlikethisatnight?:
atanytimeinyourlife? YES NO
ifYES,:inthelastyear? YES NO
ifYES,:oneormoretimesamonth? YES NO
5. Hasyourbreathingbeenlikethis?:atanytimeinyourlife? YES NO
ifYES,:inthelastyear? YES NO
ifYES,:oneormoretimesamonth? YES NO
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questionnaires will be simultaneously compared in this age group.
Andersonetalwillbestudyingthevalidityofthethreecorequestionnaires
among13yearoldsusingadetailedinterview.
The pilot study has demonstrated that presentation of the writtenquestionnaire before the video does not affect responses to the video;
howeverpresentationofthevideofirstdoesaffectresponsestothewritten
questionnaire.
5. PredictivevalidityFrequent and persistent wheezing episodes are associated with chest
deformity, residual airways obstruction, radiological evidence of
hyperinflation,andpresenceofrhonchi inthe intervalphase(Gillametel
1970,McNicoletal1970).Wheezingatage7yearspredictslaterwheezing
andthisisincreasedifoneusesfrequencyofepisodesatage7(Anderson
etal1986).
Although bronchial hyperresponsiveness (BHR) has in the past been
equatedwithasthma,populationstudieshaveshown that itsrelationship
toasthmasymptomsandasthmadiagnosisisnotclose(Josephs,Pattemore
et al). This is probably because it is only one of several mechanisms
underling clinical asthma. BHR cannotbe regarded as the gold standard
(theoneobjectiveindicatorofasthma).Nevertheless,BHRisanimportant
factorinasthma,anditsrelationshiptothetoolsbeingusedisofparticular
interest. The prevalence of wheeze foundby questionnaire relates to the
response to an exercise provocation test (Barry & Burr 1991) and other
measures of BHR (Burney et al 1989). Previous work with the video
questionnairehasshownittohavereasonablesensitivityandspecificityfor
BHRinanEnglishspeakingpopulation(Shawetal).
7.7 PresentationandtranslationItisimportantthatthequestionnairesarepreparedinaconsistentmanner.
Theorderofyes/noresponseshasbeendefined.Thelayoutandprintingof
thequestionnaireswillbestandardwitheachmodulebeingprintedona
singlepage.The4questionnairesfor1314yearoldsareusuallypresented
ononepieceof foldedpaperwith thevideoquestionnaire tobeshowingon thebackwhen folded.Alternatively theymaybepresentedseparately
withadequateidentificationoneachpage.
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Translation of questionnaires from English to other languages will be
standardised.TheEnglishversionwillbetranslated,andthenthatversion
translated back to English. These procedures will involve several
translators, in an attempt to define thebest nonEnglish version for each
region.Insomecountries(e.g.NewZealand)theinformationsheetmaybe
translatedintothemainnonEnglishlanguages,butnotthequestionnaires,
providingthevastmajorityofthepopulationareconversantwithwritten
English.
8.0 Ethicsandconduct8.1
Ethical
committee
approval
Eachcentrewillneed toobtain thenecessaryEthicsCommitteeapproval
priortothestartofthestudy.Sampleinformationsheetsappearbelow.
8.2 ModelforapproachingschoolsWhat follows is one example of the approach to schools. Centres must
proceed according to their local rules. A final goal should be a high
participationrate.
Once Ethics Committee approval hasbeen obtained, the school principal
willbeapproached forhis/hercooperationwith thestudy.Then thedata
collection will be able to commence with the cooperation of the class
teachers.Itisveryimportantthattheasthma,allergies,rhinitisandeczema
are not explicitly mentioned to school staff pupils and parents in
relationshiptothestudy.
8.2.1 Sampleinformationletterfor1314yearoldsDearChairmanofBoardofTrustees/Principal/Teachers
re: New Zealand Survey of Breathing, Nose and Skin Problems in
Children
Weare invitingsomechildrenatyourschooltotakepart inan important
studyaboutchildhealthwiththeapprovaloftheirparents.Manyschools
in Auckland are taking part in the study, and by random sampling
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techniques,yourschoolhasbeenselected.Wewishtostudychildrenaged
13and14years.
ThissurveyisbeingcarriedoutinrandomlyselectedschoolsinAuckland,
Wellington, Christchurch, Nelson and Hawkes Bay, and also in manyoverseas countries including Australia, Canada, USA, Britain and
Germany.TheAucklandsurveyisfundedbytheHealthResearchCouncil
ofNewZealand.Thepurposeofthestudyistounderstandmoreaboutthe
increasingproblemofrespiratorysymptomsinchildrenofthisagegroup.
Foryourschool,itwouldmean:
1. Identifying classes in which 1314 year olds are found and makingavailableacopyoftheclasslistswithdateofbirthifpossible.
2. During this termoneofourresearch teamwouldbring informationsheets forparents(copyenclosed) to theschool, tobedistributed to
alltheselectedchildrenoneweekbeforethestudyteamcometoyour
school.
3. We would return the next week to ask these children to completewritten questionnaires (copy enclosed) and to watch a video aboutexercise andbreathing which lasts about ten minutes. We would
requireabout40minutesintotal.
4. Wewouldcomebackaboutaweeklater,withthequestionnairesandshowthevideotoanychildrenwhowereabsentonthefirstoccasion
anaskthemtocompletethesurvey.
Oneofourresearch teamwillbe incontactwithyousoon todiscuss this
survey further. In the meantime if there is any further information you
requireaboutthesurvey,pleasedonothesitatetocontactoneofus.Ifyou
areunable toreachusdirectlyby telephone,please leaveamessagewith
oursecretaryMrsChrisThomas.
This survey has the approval of the University of Auckland Human
Subjects Ethics Committee, whose Chairman you may contact directly
aboutethicalmatters(careoftheSecretary,UniversityofAucklandHuman
Subjects Ethics Committee, University of Auckland, Private Bag 92019,Auckland;phone3737599,ext6204).
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Yourssincerely
...............
8.2.2Sample
information
letter
for
6
7
year
olds
DearChairmanofBoardofTrustees/Principal/Teachers
re: New Zealand Survey of Breathing, Nose and Skin Problems in
Children
Weare invitingsomechildrenatyourschooltotakepart inan important
studyaboutchildhealthwiththeapprovaloftheirparents.Manyschools
in Auckland are taking part in the study, and by random samplingtechniques,yourschoolhasbeenselected.Wewishtostudychildrenaged
67years.
ThissurveyisbeingcarriedoutinrandomlyselectedschoolsinAuckland,
Wellington, Christchurch, Nelson and Hawkes Bay, and also in many
overseas countries including Australia, Canada, USA, Britain and
Germany.TheAucklandsurveyisfundedbytheHealthResearchCouncil
ofNewZealand.Thepurposeofthestudyistounderstandmoreaboutthe
increasingproblemofrespiratorysymptomsinchildrenofthisagegroup.
Foryourschool,itwouldmean:
1. Identifyingclassesinwhich67yearoldsarefoundandhavingreadyacopyoftheclasslistsfortheresearcher.
2. Oneofourresearchteamwillthencomeandnameeachsurveyformanddistributethembyclasstobetakenhome.
3. We will send information sheets, and questionnaires (copiesenclosed) to the parents of the children who will be asked to
complete the questionnaire and return it to your school, to be
collectedbytheresearcher.
4. Wewouldfollowupanynonreturnedforms.5.
Wewouldwish tohave informationon thedateofbirthandsexofanypotentiallyeligiblechildrenwhodonotparticipateinthesurvey.
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Oneofourresearch teamwillbe incontactwithyousoon todiscuss this
survey further. In the meantime if there is any further information you
requireaboutthesurvey,pleasedonothesitatetocontactoneofus.Ifyou
areunable toreachusdirectlyby telephone,please leaveamessagewith
oursecretaryMrsChrisThomas.
This survey has the approval of the University of Auckland Human
Subjects Ethics Committee, whose Chairman you may contact directly
aboutethicalmatters(careoftheSecretary,UniversityofAucklandHuman
Subjects Ethics Committee, University of Auckland, Private Bag 92019,
Auckland;phone3737599,ext6204).
Yourssincerely
...............
8.3 ModelforapproachingparentsAn information sheet will be sent home with each participating child,
givingdetailsaboutthestudy.Theinformationsheetwillbetranslatedup
tofourofthemostcommonlanguagesusedbyfamiliesofeligiblechildren.
1314yearolds: The information sheet has an additional paragraph
giving the parent the right to refuse their childs
participationinthestudy.
67yearolds: Parentscompletionofthequestionnaireimpliesconsent.
8.3.1 Sampleinformationsheetforparents/guardiansof1314yearoldsDearParent/Guardian
Weareinvitingyourchildtotakepartinanimportantsurveyaboutchild
health with the approval of your school. Many schools in Auckland are
takingpartinthestudyandallclassmatesofyourchildarebeingaskedto
take part. First, your child will be asked to complete three brief
questionnaires.Thena10minutevideoaboutexerciseandbreathingwill
be shown to your child in his/her class and your child willbe asked to
completea furtherbriefquestionnaire.Thiswill takeup to40minutesof
classtime.
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ThissurveyisbeingcarriedoutinrandomlyselectedschoolsinAuckland,
Wellington,Christchurch,Nelson,HawkesBayandalsoinmanyoverseas
countries including Australia, Canada, USA, Britain and Germany. The
AucklandsurveyispartlyfundedbytheHealthResearchCouncilofNew
Zealand.
We ask you to consider this information sheet, and if you agree to your
childtakingpartinthesurvey,thenyouneedtotakenoaction.Ifyoudo
not wish your child to answer the questionnaire, please telephone the
number listed at the bottom of this page tomorrow. Your childs
questionnaire willbe treated confidentially; only a code number willbe
enteredinthecomputer.
This survey has the approval of your childs schools Board of Trustees,
Principal and teachers. It also has the approval of the University of
AucklandHumanSubjectsEthicsCommittee.
If there is any further information you require about the study, please
contactoneofus.
Yourssincerely
..............
8.3.2 Sampleinformationsheetforparents/guardiansof67yearoldsDearParent/Guardian
Weareinvitingyourchildtotakepartinanimportantsurveyaboutchild
health with the approval of your school. Many schools in Auckland are
takingpartinthestudyandallclassmatesofyourchildarebeingaskedtotakepart.Foreachchild,a parent/guardian isbeing asked to complete a
questionnaire.
ThissurveyisbeingcarriedoutinrandomlyselectedschoolsinAuckland,
Wellington,Christchurch,Nelson,HawkesBayandalsoinmanyoverseas
countries including Australia, Canada, USA, Britain and Germany. The
AucklandsurveyispartlyfundedbytheHealthResearchCouncilofNew
Zealand.
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We ask you to consider this information sheet, and if you agree to your
child taking part in the survey, then we would like you to complete the
attached questionnaire. Your childs questionnaire will be treated
confidentially;onlyacodenumberwillbeenteredinthecomputer.
This survey has the approval of your childs schools Board of Trustees,
Principal and teachers. It also has the approval of the University of
AucklandHumanSubjectsEthicsCommittee.
If there is any further information you require about the study, please
contactoneofus.
Yourssincerely
..............
8.4 GuidelinesforfieldworkersISAACresearchstaffandfieldworkersshouldnotusethetermsasthma,
allergy,rhinitisoreczemawhen
(i) advertisingthestudy(ii) presentingwrittenmaterialaboutthestudy(iii) speakingaboutthestudytoschoolstaff,parents,children(iv) speakingto1314yearoldchildrenintheclassroom.The phrases breathing survey or a survey aboutbreathing problems
areacceptabletermstouse.
Thetitleofthequestionnairesmustnotincludethewordsasthma,allergy,
rhinitis, eczema or ISAAC. An alternative title could be A survey of
Breathing, Nose and Skin Problems. Coding should not appear on the
questionnairesdeliveredtothechildrenortheirparents.Improvedlayout
of thequestionnaires isbeing developedand testedby theNewZealand
steeringcommitteemembers,andwillberecommendedforuseinthefield.
PleasecontactInnesAsherforcopiesofthesequestionnaires.
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67yearolds
Once eligible children are identified, ISAAC staff will send the
questionnairetotheparent/guardianeitherthroughtheschoolorbypost.
The parent/guardian will be asked to return the questionnaire by a
mechanismwhichincursnofinancialcosttothem.
1314yearolds
Thequestionnaireswillbeadministeredtoagroupofchildreninaschool
inonesessionatatime.Eachsessionwillcompriseverbalinstructionson
thethreesectionsbeforehandingthequestionnairesoutandinstructionsto
leave the video questions until the video is shown. Alternatively, the
questionnaires may be presented on separate sheets of paper.
Administrationwilltheninclude:
(i) handing out and completion of the written questionnaire onwheezing
(ii) handingoutandcompletionofthewrittenquestionnaireonrhinitis(iii) HandingoutandcompletionofthewrittenquestionnaireoneczemaTheorderofpresentationofthecorequestionnairesisofimportance:theyshouldalwaysbepresentedwheezingrhinitiseczema.
(iv) Handing out the written questions for the video questionnairefollowedimmediatelybytheshowingofthevideoquestionnaire;the
writtenquestionsarecompletedwhilethisisbeingshown.Thevideo
questionnairemustalwaysbeshownafterthewrittenquestionnaires
In presenting the video, there mustbe adequate technical adequacy and
visualandaudioqualitytoensuresubjectsseeitwellandhearitcorrectly.
If questionnaires have clearly notbeen completed in a comprehensible
fashion, then they could be represented to the person who originally
completed them forone furtherattempt.Theresearchworkershouldnot
give advice about the responses that might be given. Once the
questionnaire is completed, it must notbe changedby research workers
underanycircumstances.
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9.0 DataTransferThe coding manual is available upon request from the regional
coordinators.
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10.0ContactaddressesISAACExecutive:
InnesAsher(Chairperson)
DepartmentofPaediatrics
SchoolofMedicine
UniversityofAuckland
PrivateBag
Auckland
NewZealand
Ph: *64(9)3737999Fax: *64(9)3737486
RichardBeasley
DepartmentofMedicine
WellingtonSchoolofMedicine
P.O.Box7343
WellingtonSouth
Wellington
NewZealand
Ph *64(4)3855999
Fax *64(4)3895725
DavidStrachan
DepartmentofPublicHealthSciences
StGeorgesHospitalMedicalSchool
CranmerTerrace
TootingLondonSW170RE
UnitedKingdom
Ph: *44(81)7255429
Fax: *44(81)7253584
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RegionalcoordinatorsforISAAC
EUROPE
WesternEurope
UlrichKeil,StephanWeiland
InstitutfrEpidemiologieundSozialmedizin
WestflischeWilhelmsUniversitt
VonEsmarchStrae56
D48129Mnster
Germany
Ph: *49(251)835396Fax: *49(251)835300
EasternEurope/Baltics
BengtBjrkstn
DepartmentofPaediatrics
UniversityHospital
S58185Linkping
Sweden
Ph: *46(13)221331
Fax: *46(13)148265
AMERICA
NorthAmerica
FernandoMartinezRespiratorySciencesCenter
UniversityofArizona
HealthSciencesCenter
Tucson,AZ85724
USA
Ph: *1(602)6267780
Fax: *1(602)6266970
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LatinAmerica
JavierMallol
Clasificador14A
LaSerenaChile
Ph: *56(51)
Fax: *56(51)215678
AFRICA
GabrielAnabwani
DepartmentofPaediatricsFacultyofHealthSciences
P.O.Box4606
Eldoret
Kenya
Ph:
Fax: *254(321)33041
WESTERNPACIFIC
AsiaPacific
ChrisLai
DepartmentofMedicine
TheChineseUniversityofHongKong
PrinceofWalesHospital
ShatinNewTerritories
HongKong
Ph: *8526363127
Fax: *8526375396
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Oceania
InnesAsher
DepartmentofPaediatrics
SchoolofMedicineUniversityofAuckland
PrivateBag
Auckland
NewZealand
Ph: *64(9)3737999
Fax: *64(9)3737486
SOUTHEASTASIA
J.R.Shah
JaslokHospitalandResearchCentre
15,DrGDeshmukhMarg
Bombay 400026
India
Ph: *91(22)4933333
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Barry DMJ, Burr ML, Limb ES. Prevalence of asthma among 12 year old
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BurneyPGJ,LaitinenLA,PerdrizetS,HuckaufH,TattersfieldAE,ChinnS,
PoissonN,HeerenA,BrittonJR,JonesT.Validityandrepeatabilityofthe
IUATLD (1984) Bronchial Symptoms Questionnaire: an international
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CliffordRD,RadfordM,HowellJB,HolgateST.Prevalenceofrespiratory
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MontgomerySmithJ.Epidemiologyandnaturalhistoryofasthma,allergic
rhinitisandatopicdermatitis(eczema).In:MiddletonE,ReedCE,EllisEF,
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