Experiences of living with varicose veins: A systematic ... · venous insufficiency (CVI) and...

J Clin Nurs 2019281085ndash1099 emsp|emsp1085copy 2018 John Wiley amp Sons Ltdwileyonlinelibrarycomjournaljocn

Received2August2017emsp |emsp Revised8October2018emsp |emsp Accepted3November2018DOI101111jocn14720

R E V I E W

Experiences of living with varicose veins A systematic review of qualitative research

Elizabeth Lumley12 emsp|emspPatrick Phillips12 emsp|emspAhmed Aber1emsp|emsp Helen Buckley‐Woods1emsp|emspGeorgina L Jones3emsp|emspJonathan A Michaels1

1School of Health and Related Research The University of Sheffield Sheffield UK2SheffieldTeachingHospitalsNHSFoundationTrustNorthernGeneralHospitalSheffieldUK3DapertmentofPsychologySchoolofSocialSciences Leeds Beckett University Leeds UK

CorrespondenceElizabeth Lumley School of Health and Related Research The University of Sheffield Sheffield UKEmail elumleysheffieldacuk

Funding informationThispaperpresentsindependentresearchfundedbytheNationalInstituteforHealthResearch(NIHR)undertheProgrammeGrantsforAppliedResearchprogramme(RPPG‐1210‐12009)Theviewsexpressedare those of the authors and not necessarily thoseoftheNHStheNIHRortheDepartmentofHealth

AbstractAimToidentifythesymptomsandqualityoflifeimpactsthatareimportantfromtheperspective of patients with varicose veins and to compare identified themes toitemsinvaricoseveinpatient‐reportedoutcomemeasures(PROMs)Background Varicose veins are common worldwide and are considered a chronic conditionwithimplicationsforqualityoflifeTreatmentispredominantlyconserva‐tivethereforeunderstandingpatientsrsquoexperiencesof livingwithvaricoseveins isimportanttoinformtheprovisionofclinicalcarePROMsareoftenusedtocollectdataaboutpatientsrsquoqualityoflifeDesignThematicsynthesisofqualitativeresearchreportedaccordingtoENTREQguidelinesMethods Multiple electronic databases including MEDLINE and CINAHL were systematically searched to identify qualitative research examining experiences ofadults with varicose veins Thematic synthesis was then conducted on the included studiesResultsThreestudiesmettheinclusioncriteriathequalityofthestudieswashighTherangeandintensityofreportedsymptomsandparticipantsexperiencesoflivingwithvaricoseveinswerevariedFiveoverarchingthemeswereidentifiedphysicalpsychologicalandsocialimpactofvaricoseveinsadaptingtovaricoseveinsandrea‐sonsforseekingtreatmentTheoverallkeythemetoemergewasadaptationwithpatientsdemonstratinghowtheyadaptedtothevariousimpactsConclusionThisreviewdemonstratesthatvaricoseveinshaveawiderangeofsymp‐tomsandmayhaveasignificant impactonqualityof lifepeoplemadesignificantadaptationstoenablethemtolivetheirlivesasfullyaspossibleRelevance to Clinical PracticeHealthcare professionals need to be aware of therangeofsymptomsandtheirimpactonqualityoflifeTheuseofPROMstogatherinformationaboutqualityoflifeandsymptomsiswellestablishedgloballyhoweverPROMscurrentlyusedmaynot capture the full extentof the impactonpatientsqualityoflife

K E Y W O R D S

patient‐reportedoutcomemeasuresPROMsqualitativeresearchqualityoflifesymptomssystematic review varicose veins

1086emsp |emsp emspensp LUMLEY Et aL

1emsp |emspINTRODUC TION

Varicoseveins(VV)arearelativelycommonvascularconditionglob‐allywithworldwide prevalence ranging from 5 to 15 formenand2to29forwomen (HealthQualityOntario (HQO)2011)VeinproblemsareamongstthemostcommonchronicconditionsinNorthAmericaandWesternEurope(VascularDiseaseFoundation2005)LowerlimbVVareestimatedtobetheseventhmostcommonreasonforphysicianreferralintheUnitedStates(USA)affectinganestimated35oftheUSpopulation(HQO2011)VVarealsothemostprevalentvascularconditiontreatedbyphysiciansinAustralia(Wong2016)

It is estimated that VV affect at least a third of the UnitedKingdom(UK)(EvansLeeAllanRuckleyampFowkes2014)andupto40ofthegeneralpopulation(Robertsonetal2016)

VVareoneof anumberof symptomsassociatedwithchronicvenous insufficiency (CVI) and chronic venousdisease (CVD)CVIoccurs when the venous wall andor valves in the leg veins are not workingeffectivelycausingbloodtocollectintheveinsTherefluxofbloodresultsinVVwhichbecomeenlargedlumpyandvisibleandareusuallypresentinlowerlimbs

VV cause symptoms such as throbbing pain aching swellingcrampingitchingandbleeding(PalfreymanampMichaels2009)VV‐associatedsymptomsandconsequentialrestrictionsontheabilitytowalkandstandcanhaveasubstantialimpactonpatientqualityof life (QoL) (Darvall BateAdamampBradbury 2012Kahn et al2004)

Anestimated30ofpeoplewithVVwilldevelopskinchangessuch as eczema oedema and skin discoloration associated with CVD(Leeetal2015) Inadditionbetween3and6ofpeoplewith VVwill progress to developing venous leg ulcers (VLU) an‐otherchronicconditionassociatedwithCVI (National InstituteforHealthandCareExcellence(NICE)2013)Approximately2ofUKNationalHealthService(NHS)resourcesarespentonmanagingve‐nous disease (Shingler Robertson Boghossian amp Stewart 2013)with35659VVprocedures carriedout in theNHS in20092010alone(NICE2013)

VVcanbetreatedconservativelythroughtheuseofcompres‐sion hosiery and lifestyle advice Compression therapy does notactively treat CVD and it is used to manage symptoms such asswellingheavinessandpainandtohelpbloodflowandvenousre‐turnthusslowingdiseaseprogression(NICE2013)Patientsshouldalsoreceiveadviceregardingweightlifestylemeasurestopreventsymptomsworseningsuchaselevatinglegsandtheimportanceofskincare(NICE2013)

However adherence to treatment can be an issue and the ev‐idence base for the effectiveness of these approaches is limited(Shingler et al 2013) Alternatively invasive treatments such asendothermalablation foamsclerotherapyandsurgerymaybere‐quiredtoreducesymptomsandslowdiseaseprogression

Decisions on how and when to treat VV are subject to varia‐tion across theUK and are based on local interpretation ofNICE

guidance and referral guidelines by regional clinical commission‐inggroups(CCG)(LimGohelShepherdampDavies2010MarsdenPerryKelleyampDavies2013)QoLissuesmaybedecidingfactorsin treatment decisions therefore understanding the effect that VV haveonQoLisimportant

OnemethodofcollectingdataaboutQoListheuseofpatient‐reportedoutcomemeasures(PROMs)PROMscompriseofaseriesof structured questions that ask patients about their health andhealth‐related QoL from their point of view (Devlin amp Appleby2010)PROMsprovide informationabout the impactofadiseaseoritsassociatedtreatmentfromapatientsrsquoperspectivetheydonotaskaboutsatisfactionwithorexperienceofhealthcareservices

PROMsareusedinternationallybyhealthorganisationsbothtocollectroutinedatatoinformpolicydecisionsandbyindividualcli‐nicians togatherpatient information inorder toguideclinicalandshareddecision‐making(Black2013)PROMsareeithergenericsotheycanbeusedacrossdifferentpopulationsandhealthconditionsandcanallowcomparisonbetweengroupsortheycanbedisease‐orcondition‐specificcontainingitemsthataremorerelevanttothatspecificgroup

PROMs are used globally although their use is better estab‐lishedincountriessuchastheUKtheNetherlandsSwedenandtheUSA (Williams SansoniMorrisGrootemaatampThompson2016)IntheUSAtheFoodandDrugAdministration(FDA)recommendedthat PROMs should be included in all clinical trials (FDA 2009)

What does this paper contribute to the wider global clinical community

bull This review identifies that there are a wide range of symptoms of varicose veins and that symptoms canhavea significant impactonpatientsrsquoqualityof life Itdemonstrates that patients often adapt their lives inordertocopewiththerangeofimpactsthattheirvari‐cose veins have

bull Ithighlightsthatanumberofdifferentinstrumentscanbe used to measure the effects of varicose veins how‐everitisclearthatnoinstrumentcurrentlycapturesthefullimpactofvaricoseveinsonqualityoflife

bull Healthcare professionals need to ensure patients arefullyinformedofallaspectsoftheirconditioninordertohelpwithself‐managementincreaseadherencetocom‐pression therapy allay unfounded fears and managetreatmentexpectations

bull Familiaritywiththefindingsofexistingqualitativelitera‐ture through qualitative reviews or employment ofqualitative researchmethods such as interviews ena‐blesanin‐depthunderstandingoftherangeandsever‐ityofsymptomsandresultingimpactonqualityoflifeexperiencedbypatients

emspensp emsp | emsp1087LUMLEY Et aL

Morerecently in2016acommissionwasestablished inAustraliatoreviewtherationaleanduseofPROMsinordertohelpembedtheuseofPROMsintheAustralianhealthcaresystem(Williamsetal2016)

DespitetheincreasinguseofPROMsinclinicalpracticeitisim‐portanttonotethattherearelimitationsintheiruseduetoissuesofvalidityandreliabilityrelatedtothenatureofself‐reportRelyingonpatientstoself‐reporttheirhealthcanbechallengingparticularlywithpatientssufferingfromcognitivedeficitsparalysisordementiathosewhomaynotreadorspeakEnglishorthosethatarenotlit‐erate(childrenandbabies)ProxyversionsofPROMs(egthatcanbecompletedbycaregivers)andPROMsdesignedforcompletionbyspecificgroupssuchaschildrendoexisthowevertherelianceonself‐reportinghealthpresentsanissuefortheuseofPROMsinsomecontexts (DevlinampAppleby 2010) PROMsdata should thereforebeseenascomplementingratherthanreplacingclinicalandotherinformationaboutpatients

Since2009intheUKNHSprovidershavebeenrequiredtocol‐lectPROMsforfoursurgicalproceduresincludingVVtreatmenttheotherthreeproceduresareherniarepairandhipandkneereplace‐mentsCompletionofPROMsisvoluntaryandpatientsareundernoobligation to take part In 2013ndash2014 PROMcompletion rates forVVpatientswereconsiderablylowerthanfortheotherproceduresjust405comparedwithhipandkneesurgeryatnearly86and94andanaverageof76acrossall fourprocedures (HealthandSocialCare InformationCentre (HSCIC)2016)Theredoesnot ap‐peartobeanyestablishedreasonwhyVVPROMcompletionratesaresocomparativelypoorhoweveroneexplanationcouldbe thatthe PROMs being used do not contain items that are relevant toVVpatientsTheNHScurrentlyusesthegenericPROMtheEQ5DEQ5D‐VAS(EuroQol1990)andthecondition‐specificAberdeenVVQuestionnaire(AVVQ)(Garrattetal1993)todatethereisnopub‐lishedevidence that theEQ5Dhasbeenvalidated forusewithVVpatients

A recent systematic review (Aber et al 2017) was conductedto identify PROMs that have undergone some kind of publishedvalidation for use with VV patients and assess their psychometricpropertiesThreedisease‐specificPROMstheAVVQ(Garrattetal1993)VVSymptomQuestionnaire(VVSymQ)(PatyTurner‐BowkerElashampWright2016)andSpecificQoLOutcomeResponse‐Venous(SQOR‐V) (Guex Zimmet Boussetta Nguyen amp Taieb 2007) andonegenericPROMtheShort‐Form36(SF‐36)(WareampSherbourne1992)wereidentifiedThereviewconcludedthatbasedonitspsy‐chometricpropertiestheAVVQwasthemostappropriatedisease‐specific instrumentwith evidenceof construct validity testndashretestreliabilityand responsivenessbut lessevidence forcontentvalidityandacceptabilityAnexampleofthequestionsfromtheAVVQcanbeseeninAppendixS1TheSF‐36wasthemostsuitablegenericPROMforusewithpatientswithVVwithsatisfactoryresponsivenessandacceptability but with limited assessment of other psychometricproperties

Currently NICE VV guidance suggests that ldquoQuality‐of‐lifemeasures are unlikely to reflect severity of disease because of

variations inperceptionof symptomsrdquo (NICE2013) thereforeit is necessary to assess whether these existing PROMs actu‐ally reflect the symptomsand issues that aremost relevant topatients

Content validity of PROMs is the extent to which items ona test are representative of what is intended to be measuredContent validity when developing PROMs can be enhanced byusing qualitative researchmethods such as interviewswith pa‐tientstodeterminewhichissuesarerelevanttothepatientgroupand using these findings to develop the items incorporated intothePROM

WhetherusedinclinicalpracticeorasaresearchtoolPROMsshouldberigorouslydevelopedtoensurethattheyadequatelyrep‐resentandcapturetheexperiencesofthepopulationtheyaretobe used with

QoLiscentraltotheindividualpatientsexperienceofhealthanddiseasemeasures ofQoLmust domore than describe a patientshealth in terms of what health professionals and society believeconstitutes health (Carr amp Higginson 2001) The measurement ofimprovementsorotherwiseinQoLassociatedwithpatient‐centredcareshouldpreferablybeperformedusingPROMsthathavebeenconstructedwiththe involvementofthoseexperiencingthehealthstate

Thisqualitativeevidencesynthesisisrelatedtotheidentifica‐tionandevaluationofexistingcondition‐specificorgenericPROMsthathavebeenvalidatedforuseinpopulationswithvascularcondi‐tionsThesynthesisisalsoanintegralpartofthedevelopmentofanewPROMspecificallyanelectronicpatientquestionnaire(ePAQ‐VAS)foruseinthispopulationThereviewcomplementsaseriesofotherprojectsundertakenaspartofaNationalInstituteforHealthResearch (NIHR) Programme GrantmdashThe Vascular ProgrammeGrant (VPG) Project ID RP‐PG‐1210‐12009) which has the aimof evaluating vascular services and making recommendations re‐gardingpatient‐focusedcareProgrammeworkstreamsincludethefollowing

bull Similarreviewsofqualitativeevidenceoffourothervascularcon‐ditions(abdominalaorticaneurysm(AAA)carotidarterydisease(CAD)peripheralarterialdisease(PAD)andVLU)

bull FivesystematicreviewsidentifyingandevaluatingPROMsusedbypatientswithfivevascularconditions (AAACADPADVLUandVV)

bull Primary qualitative research into the experience of living withthese five vascular conditions

11emsp|emspAims

1 The primary aim of this qualitative evidence synthesis was toexamine the symptoms and QoL domains that are importantfrom the perspective of patients with VV

2 Asecondaryaimwastocomparethethemesidentifiedinthesyn‐thesistoitemsinPROMscurrentlyusedwithVVpatients


2emsp |emspMETHODS

This systematic review was conducted using explicit systematicmethods to reduce the riskofbias andprovide reliable findings inaccordancewithpublishedguidelines(HigginsampGreen2011)spe‐cifically a thematic synthesis was conducted as this is a recognised methodusedinsystematicreviewsofqualitativeresearchwhichpre‐servesanexplicitandtransparent linkbetweenreviewconclusionsand the primary researchThomas andHarden (2008) This reviewfollows the design established in a prepublished protocol (Duncanetal2016)titledldquoUnderstandingtheexperienceandimpactofliv‐ingwithavascularconditionfromthepatientsrsquoperspectiverdquoandisreported according to the ldquoEnhancing Transparency in ReportingtheSynthesisofQualitativeResearchrdquo (ENTREQ) statement (TongFlemmingMcInnesOliverampCraig 2012) The ENTREQ checklistcanbeseeninsupplementaryFileS1

21emsp|emspStudy identification and selection

Studies were included if they were primary qualitative researchstudies including populations of adults with VV and published inEnglishMixed‐methods studies where details of data collectionanalysesandresultsofthequalitativeportionofthestudywerere‐portedseparatelywereincludedAppendixS2showstheeligibilitycriteria

SearcheswereconductedinCinahlEmbaseMedlinePsycINFOScience Citation Index and the Social Science Citation Index andProQuest dissertations and theses No language or date restric‐tionswereappliedasan initialscopingsearchhad identifieda lackof available literature in this subject area Additionally reference lists of included studies and related reviews were scrutinised and cita‐tionsearcheswereconducted(seeAppendixS3forfulldetailsofthesearchstrategy)

Tworeviewers(ELandPP)independentlyscreenedthetitleandabstract of all studies identified by the searches with reference to theinclusionandexclusioncriteriainthepublishedprotocolAllpo‐tentialfull‐textpaperswerereadanddiscussionwasusedtoresolveanydifferenceofopinionAthirdresearcher(AA)wasavailableforconsultation if consensus could not be reached

22emsp|emspData extraction and quality assessment

Dataextractionwasconductedusingastudy‐specificdataextrac‐tion form details of author date country research design method ofanalysisaimsandobjectivessampleincludingageandgenderdiagnosisandeligibilitycriteriawerecollected (AppendixS4)TheCritical Appraisal Skills Programme (CASP) qualitative researchchecklistwasemployedtoassessthemethodologicalqualityoftheincluded papers including trustworthiness and relevance (CASP2014)TheCASPchecklistwaschosenas itassessesboththeap‐propriatenessandqualityofreportingandiscommonlyusedinqual‐itative reviews of evidence (CarrollampBooth 2014) The checklistcomprisesoftenquestionsaboutthequalitativemethodologyand

areansweredeitherldquoyesrdquoldquonordquoorldquounclearrdquoQualityassessmentwasconductedindependentlybytworesearchers(ELandPP)andanydiscrepancieswereresolvedthroughdiscussionfollowingtheCASPcriteria

23emsp|emspData analysis

Eachfull‐textpaperwasuploadedelectronicallyintoNVIVO10(QSRInternational Burlington USA) the reviewers read through eachof thepapers to familiarise themselveswith thestudyand resultsthe results sections were then analysed using thematic synthesis (ThomasampHarden2008)

Interobserveragreementofcodingwascheckedandconsensuswashighshowingsubstantialalmostperfectorperfectagreementwithkappacoefficientratingcommonlybetween061and1(VieraampGarrett2005)

Aprovisionalthematicframework(AppendixS5)wasdevelopedusingconceptualdomainsfromPROMsvalidatedforusewithVVpa‐tients(AppendixS6)thatwereidentifiedinaseparatereview(Aberetal2017)

InitialcodingofthetextwasconductedindependentlylinebylinewithrelevantsectionsandquotationshighlightedandassignedtothespecificnodesoftheprovisionalthematicframeworkTherewasthepotentialtoconstrainorlimitthedeductionofnewthemesbyusingapreliminaryframeworkhoweveritdidnotpredeterminethefinalthemes

Comparisons were made across the three included studiesmatching emergent themes to those already established in the frameworkWherenewconceptswereidentifiedadditionalthemeswerecreatedandpreviouslycodedpaperswerere‐visitedtoestab‐lishwhetheranyaspectsoftheirfindingsmatchedthenewlycreatedthemeTheclassificationoftextaccordingtoexistingandemergentthemesiscomparabletothedevelopmentofdescriptivethemesinthematicanalysis (ThomasampHarden2008)wherethemesremainldquoclose to theprimary studyrdquo Figure1demonstrates the synthesisprocess

3emsp |emspRESULTS

A total of 1804 referenceswere identified following the removalof duplicates 1318 citations were screened of these 56 full‐textarticleswereretrievedandscreenedforeligibilityofthese53wereexcludedReasonsforexclusionwereasfollowsThepaperwasnotavailable in English the study populationwas not clearly definedsolelyasVVor thestudywasnotqualitative researchordidnotdetail data collection or analysis methods Study selection is detailed in thePRISMAflowdiagram (MoherLiberatiTeetzlaffampAltman2009)(Figure2)

Three independent studies that met the inclusion criteriawere identified (Table 1) The studieswere published between2004 and2016 andwere conducted in Sweden (n=1) and theUK (n=2)


31emsp|emspQuality assessment

The overall quality of the included studies was high with posi‐tive responses formost items on the CASP checklist (AppendixS7) Positive responses indicate that the paper hasmet the rel‐evantCASPcriteriaforcredibilityandrigourHowevertwoofthethreestudiesdidnotfullyconsidertherelationshipbetweentheresearcherandstudyparticipantsthereforepotentiallyintroduc‐ingbias into the researchprocessStudieswerenotexcludedorweightedbasedonquality

4emsp |emspTHEMES

FiveoverarchingthemeswereidentifiedphysicalimpactofVVpsy‐chologicalimpactsocialimpactadaptingtoVVandreasonsforseeking

treatmentWithinthesemainthemesfurthersubthemeswereidenti‐fiedsymptomssymptommanagementphysicalfunctionworryanxi‐etyappearancesocialrestrictionsandrelationships(Table2)

41emsp|emspPhysical impact

ThephysicalimpactofVVwasevidentacrossallthreeincludedpa‐persaswere thesubthemesof symptomsmanagementof symp‐tomsandphysicalfunction

411emsp|emspSymptoms

Descriptionsofpainheavinessanditchingwerecommontopar‐ticipants in all three studieswith swelling reported in only twopapers Cramps tingling and numbness were also reported astroublesomesymptoms(FranzampWann‐Hansson2015)reflecting

F I G U R E 1 emspApplicationofframeworksynthesis[Colourfigurecanbeviewedatwileyonlinelibrarycom]

Familiarisation

Comparison of PROMs including identification and

interpretation of itemsdomains

Development of provisional framework of themes and

subthemes for use in analysis of included studies

Systematic identification of qualitative research studies

examining the experiences of people living with VV

Provisional framework for analysis entered into NVIVO

Reviewers familiarize themselves with included studies and upload

papers as sources into NVIVO

Iterative process of line-by-line coding of included studies in NVIVO with categorisation to

putative themes including addition of and categorisation to

new emergent themes

Continuous re-examination of analysed studies as new themes

emerge and the thematic framework develops to ensure a comprehensive and consistent analysis has been conducted

Thematic framework finalised facilitating a coherent synthesis

presentation and discussion of the impact of VV on QoL with reference

to itemsdomains in PROMs used with VV populations

Familiarisation with PROMs validated in populations

with VV


thebroadrangeofphysicalsymptomsdescribedacrossthethreepapers The symptomsoftenhad an impact onother aspects oflifesuchassleepresulting inparticipantsfeelingtiredThedis‐tressassociatedwithsymptomsisclearlydescribedbysomestudyparticipantswhilstforothersthesymptomswerelesstroubling

They drive me mad absolutely mad with the itching Ill scratch them and scratch them thatmuch that ImakethemlikeyouknowscratchmarksImakethembleedwiththescratchmarks Participant13mdashPalfreymanetal

ItusedtoaffecteverythingIwoulddoeverydayhellipitwas really awfulhellipmy legswere so soreanduncom‐fortable Patient14mdashHudsonetal

TheywerentpainfulexactlybutermattheendofthedayIwouldbeconsciousofthemliketheywereachyyouknownotpainful Patient9mdashHudsonetal

412emsp|emspManagement of symptoms

Allthreepaperscontaineddescriptionsofhowparticipantsuseddif‐ferentstrategiestomanagetheimpactoftheirsymptomsThemaincoping strategies employedwere elevationof legs and theuseofcreamsointmentsandcompressionhosieryHoweverwherethesestrategieswereineffectiveorinappropriateindividualscalledupontheir own internal resources

Theuseofcompressionhosierywasvieweddifferently inthetwostudiesthatcommentFranzandWannHansenwhilstacknowledgingthedifficultiesinvolvedinwearingcompressionhosieryreportbenefitsin reducing swelling and suggest and that for some individuals the use of stockingsiscrucialtogettingeverydayworkdoneIncontrastPalfreymanetalreportawidespreaddissatisfactionwiththeuseofcompressionho‐sierybypatientswhichtosomeextentseemedtobesharedbyclinicians

The doctor (at the outpatient clinic) asked if I usedstockingsIsaidtheyreawasteoftimeHesaysldquoYouthinksoIminclinedtoagreewirsquothatrdquo Participant1mdashPalfreymanetal

Palfreymanetalalsonotedtheuseofanalgesiatomanagepainanddiscomfortwithoneparticipantdescribingtheuseofarangeofnonsteroidal anti‐inflammatories (NSAIDs) with varying effects andanotherparticipantusingparacetamolcodeinecombinations

Themanagement of symptoms theme is directly linked to theldquoAdaptingtoVVrdquothemeasallthreepapersreporthowparticipantsmakelifeadaptationsaswellaspracticalonestorelievesymptomsinanefforttocopewithalifewithVV

ThelastfewdaysIliterallycrawledthroughthedoorandhadtositdownwithmyfeetuphightogetthebloodandswellingdown Patient14mdashHudsonetal

I put creamon you know soothing cream like cala‐mine and stuff like that and that voltarol gel thatsquitegood Participant5ndashPalfreymanetal

F I G U R E 2 emspPRISMA2009flowdiagram

Records idenfied through database searching

(n = 1804)

Addional records idenfied through other sources

(n = 0)

Records aer duplicates removed (n = 1318)

Records screened (n = 1318)

Records excluded (n = 1262)

Full-text articles assessed for eligibility

(n = 56)

Full-text arcles excluded with reasons

(n = 53)

Studies included in qualitave synthesis

(n = 3)


IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson

SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal

413emsp|emspPhysical function

None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced

limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)

Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work

Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al

42emsp|emspPsychological impact

Psychological impactencompassedsubthemesofworryoranxietyandappearance

TA B L E 1 emsp Includedstudies

Author and year Country Research design Sample Main findings

FranzandWann‐Hansson(2015)

Sweden Exploratoryqualitativestudywithphenomenologicalapproach

12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance

Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)

Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition

HudsonOgdenandWhiteley(2015)

UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)

20 (four from each arm of thewiderRCT)

Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being

Thematic analysis Age(mean)508years Gender (30male) (620)

Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved

PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)

UK Qualitativeusingsemi‐ structured interviews

16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief

Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)

ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit


421emsp|emspWorry or anxiety

InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends

Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson

InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal

Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal

422emsp|emspAppearance

ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction

Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly

TA B L E 2 emspThemesidentifiedfromincludedpapers

Main theme SubthemePalfreyman et al (2004)

Hudson et al (2015)

Franz amp Wann‐Hansson (2015)

1Physicalimpact Symptoms

Heaviness

Itching

Pain

Swelling times

Othersymptoms(phlebitistiredness)

Sleep times

Management of symptoms

Copingstrategies

Compression times

Analgesia times times

Elevation

Physical function

Limitations

Work times

2Psychologicalimpact Worryanxiety

Futurehealthproblems

Deterioration

Appearance

Personalfeelings(embarrass‐mentself‐consciousdisgust)

Reactions of others

Self‐imageself‐esteem times times

3Impactonsocialfunctioning Restrictions

Relationships

4Reasonsforseekingtreatment Symptomrelief times

Cosmeticconcerns times

Preventfutureproblems times

5AdaptingtoVV Lifeadaptations

Clothingadaptations


andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal

hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal

ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson

These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming

I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal

Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson

Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions

She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal

43emsp|emspSocial impact

Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships

431emsp|emspRestrictions

Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise

ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo

ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson

If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal

ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them

432emsp|emspRelationships

TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships

One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal

IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal

44emsp|emspReasons for seeking treatment

Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact

More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal

OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal


45emsp|emspAdaptation

Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined

Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson

Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations

WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson

Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson

Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused

Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al

ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson

Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal

5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES

The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making

The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis

Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire

Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)

ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement

Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway

Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo

The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof


symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions

Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery

Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention

Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over

20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)

ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant

Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers

TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes

Qualitative review analysis themes

PROM

PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4

Physicalimpact Adaptation

times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3

Socialimpact Adaptation

times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice

Psychologicalimpact Adaptation

times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications


Pain1 Painache2 Paindiscomfort3 Achiness4

Psychologicalimpact times times Healthperceptions1 Riskthreat to health3


times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice

Physicalimpact times times times Progression3

NA times times times Vitality1


times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3


thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety

OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health

ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others

IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs

Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV

Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ

Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme

Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations

Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture

Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare

professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations

Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially

Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted

TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)

Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife

NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully

51emsp|emspFurther researchmdashconstruction of PROMs

The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature

Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences

Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature

AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition


Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures

The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy

6emsp |emspCONCLUSION

Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)

The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL

Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice

61emsp|emspRelevance to clinical practice

bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture

bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition

bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them

bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety

bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future

7emsp |emspLIMITATIONS

Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch

ACKNOWLEDG EMENTS

The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator

CONFLIC TS OF INTERE S T

Noconflictofinteresthasbeendeclaredbytheauthors

AUTHOR CONTRIBUTION

AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent

ORCID

Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568


R E FE R E N C E S

AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432

BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167

CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357

Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128

Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists

DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014

DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344

DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications

DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143

Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf

EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml

EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017

Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm

FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741

GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905

GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10

GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147

Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf

HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93

Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg

HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719

KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828

LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26

Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035

Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279

MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005

NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168

NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150

PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x

PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003

Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193

Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017


SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf

Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3

ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45

Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181

vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057

VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf

VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363

Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483

Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC

Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer

SUPPORTING INFORMATION

Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle

How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720


1emsp |emspINTRODUC TION

Varicoseveins(VV)arearelativelycommonvascularconditionglob‐allywithworldwide prevalence ranging from 5 to 15 formenand2to29forwomen (HealthQualityOntario (HQO)2011)VeinproblemsareamongstthemostcommonchronicconditionsinNorthAmericaandWesternEurope(VascularDiseaseFoundation2005)LowerlimbVVareestimatedtobetheseventhmostcommonreasonforphysicianreferralintheUnitedStates(USA)affectinganestimated35oftheUSpopulation(HQO2011)VVarealsothemostprevalentvascularconditiontreatedbyphysiciansinAustralia(Wong2016)

It is estimated that VV affect at least a third of the UnitedKingdom(UK)(EvansLeeAllanRuckleyampFowkes2014)andupto40ofthegeneralpopulation(Robertsonetal2016)

VVareoneof anumberof symptomsassociatedwithchronicvenous insufficiency (CVI) and chronic venousdisease (CVD)CVIoccurs when the venous wall andor valves in the leg veins are not workingeffectivelycausingbloodtocollectintheveinsTherefluxofbloodresultsinVVwhichbecomeenlargedlumpyandvisibleandareusuallypresentinlowerlimbs

VV cause symptoms such as throbbing pain aching swellingcrampingitchingandbleeding(PalfreymanampMichaels2009)VV‐associatedsymptomsandconsequentialrestrictionsontheabilitytowalkandstandcanhaveasubstantialimpactonpatientqualityof life (QoL) (Darvall BateAdamampBradbury 2012Kahn et al2004)

Anestimated30ofpeoplewithVVwilldevelopskinchangessuch as eczema oedema and skin discoloration associated with CVD(Leeetal2015) Inadditionbetween3and6ofpeoplewith VVwill progress to developing venous leg ulcers (VLU) an‐otherchronicconditionassociatedwithCVI (National InstituteforHealthandCareExcellence(NICE)2013)Approximately2ofUKNationalHealthService(NHS)resourcesarespentonmanagingve‐nous disease (Shingler Robertson Boghossian amp Stewart 2013)with35659VVprocedures carriedout in theNHS in20092010alone(NICE2013)

VVcanbetreatedconservativelythroughtheuseofcompres‐sion hosiery and lifestyle advice Compression therapy does notactively treat CVD and it is used to manage symptoms such asswellingheavinessandpainandtohelpbloodflowandvenousre‐turnthusslowingdiseaseprogression(NICE2013)Patientsshouldalsoreceiveadviceregardingweightlifestylemeasurestopreventsymptomsworseningsuchaselevatinglegsandtheimportanceofskincare(NICE2013)

However adherence to treatment can be an issue and the ev‐idence base for the effectiveness of these approaches is limited(Shingler et al 2013) Alternatively invasive treatments such asendothermalablation foamsclerotherapyandsurgerymaybere‐quiredtoreducesymptomsandslowdiseaseprogression

Decisions on how and when to treat VV are subject to varia‐tion across theUK and are based on local interpretation ofNICE

guidance and referral guidelines by regional clinical commission‐inggroups(CCG)(LimGohelShepherdampDavies2010MarsdenPerryKelleyampDavies2013)QoLissuesmaybedecidingfactorsin treatment decisions therefore understanding the effect that VV haveonQoLisimportant

OnemethodofcollectingdataaboutQoListheuseofpatient‐reportedoutcomemeasures(PROMs)PROMscompriseofaseriesof structured questions that ask patients about their health andhealth‐related QoL from their point of view (Devlin amp Appleby2010)PROMsprovide informationabout the impactofadiseaseoritsassociatedtreatmentfromapatientsrsquoperspectivetheydonotaskaboutsatisfactionwithorexperienceofhealthcareservices

PROMsareusedinternationallybyhealthorganisationsbothtocollectroutinedatatoinformpolicydecisionsandbyindividualcli‐nicians togatherpatient information inorder toguideclinicalandshareddecision‐making(Black2013)PROMsareeithergenericsotheycanbeusedacrossdifferentpopulationsandhealthconditionsandcanallowcomparisonbetweengroupsortheycanbedisease‐orcondition‐specificcontainingitemsthataremorerelevanttothatspecificgroup

PROMs are used globally although their use is better estab‐lishedincountriessuchastheUKtheNetherlandsSwedenandtheUSA (Williams SansoniMorrisGrootemaatampThompson2016)IntheUSAtheFoodandDrugAdministration(FDA)recommendedthat PROMs should be included in all clinical trials (FDA 2009)

What does this paper contribute to the wider global clinical community

bull This review identifies that there are a wide range of symptoms of varicose veins and that symptoms canhavea significant impactonpatientsrsquoqualityof life Itdemonstrates that patients often adapt their lives inordertocopewiththerangeofimpactsthattheirvari‐cose veins have

bull Ithighlightsthatanumberofdifferentinstrumentscanbe used to measure the effects of varicose veins how‐everitisclearthatnoinstrumentcurrentlycapturesthefullimpactofvaricoseveinsonqualityoflife

bull Healthcare professionals need to ensure patients arefullyinformedofallaspectsoftheirconditioninordertohelpwithself‐managementincreaseadherencetocom‐pression therapy allay unfounded fears and managetreatmentexpectations

bull Familiaritywiththefindingsofexistingqualitativelitera‐ture through qualitative reviews or employment ofqualitative researchmethods such as interviews ena‐blesanin‐depthunderstandingoftherangeandsever‐ityofsymptomsandresultingimpactonqualityoflifeexperiencedbypatients















11emsp|emspAims




2emsp |emspMETHODS















3emsp |emspRESULTS






4emsp |emspTHEMES








Familiarisation












new emergent themes







with VV
















(n = 1804)


(n = 0)





(n = 56)


(n = 53)


(n = 3)








































Hudson et al (2015)



Heaviness

Itching

Pain

Swelling times


Sleep times


Copingstrategies

Compression times


Elevation

Physical function

Limitations

Work times



Deterioration

Appearance


Reactions of others



Relationships





Clothingadaptations
























































PROM






















































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S





























































11emsp|emspAims




2emsp |emspMETHODS















3emsp |emspRESULTS






4emsp |emspTHEMES








Familiarisation












new emergent themes







with VV
















(n = 1804)


(n = 0)





(n = 56)


(n = 53)


(n = 3)








































Hudson et al (2015)



Heaviness

Itching

Pain

Swelling times


Sleep times


Copingstrategies

Compression times


Elevation

Physical function

Limitations

Work times



Deterioration

Appearance


Reactions of others



Relationships





Clothingadaptations
























































PROM






















































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S
















































2emsp |emspMETHODS















3emsp |emspRESULTS






4emsp |emspTHEMES








Familiarisation












new emergent themes







with VV
















(n = 1804)


(n = 0)





(n = 56)


(n = 53)


(n = 3)








































Hudson et al (2015)



Heaviness

Itching

Pain

Swelling times


Sleep times


Copingstrategies

Compression times


Elevation

Physical function

Limitations

Work times



Deterioration

Appearance


Reactions of others



Relationships





Clothingadaptations
























































PROM






















































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S


















































4emsp |emspTHEMES








Familiarisation












new emergent themes







with VV
















(n = 1804)


(n = 0)





(n = 56)


(n = 53)


(n = 3)








































Hudson et al (2015)



Heaviness

Itching

Pain

Swelling times


Sleep times


Copingstrategies

Compression times


Elevation

Physical function

Limitations

Work times



Deterioration

Appearance


Reactions of others



Relationships





Clothingadaptations
























































PROM






















































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S






























































(n = 1804)


(n = 0)





(n = 56)


(n = 53)


(n = 3)








































Hudson et al (2015)



Heaviness

Itching

Pain

Swelling times


Sleep times


Copingstrategies

Compression times


Elevation

Physical function

Limitations

Work times



Deterioration

Appearance


Reactions of others



Relationships





Clothingadaptations
























































PROM






















































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S






















































































Hudson et al (2015)



Heaviness

Itching

Pain

Swelling times


Sleep times


Copingstrategies

Compression times


Elevation

Physical function

Limitations

Work times



Deterioration

Appearance


Reactions of others



Relationships





Clothingadaptations
























































PROM






















































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S






































































































PROM






















































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S




















































































ACKNOWLEDG EMENTS




AUTHOR CONTRIBUTION


ORCID



R E FE R E N C E S
















































R E FE R E N C E S















































Experiences of living with varicose veins: A systematic ... · venous insufficiency (CVI) and...

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Transcript of Experiences of living with varicose veins: A systematic ... · venous insufficiency (CVI) and...