Preprint,whichdiffersfromthepublishedversioninsmallways.Finalversionavailableas: Christopher James Vincent, Ann Blandford, Bags, batteries and boxes: A qualitative interview study to understand how syringe drivers are adapted and used by healthcare staff, Applied Ergonomics, Volume 63, September 2017, Pages 115-122, ISSN 0003-6870, https://doi.org/10.1016/j.apergo.2017.04.012.

Bags,batteriesandboxes:AqualitativeinterviewstudytounderstandhowsyringedriversareadaptedandusedbyhealthcarestaffC.J.Vincent&A.BlandfordAbstractSyringedriversaremedicaldevicesthatarecriticalforendoflifecare.Theydelivercontinuousmedicationoverextendedperiodsoftime.Theirdesigncontributestothequalityofexperienceforbothpatientsandhealthcareprofessionals.Littleresearchhasbeenpublishedaboutthefactorsthatinfluencetheusabilityofthistypeofequipmentforfrontlineusers(i.e.thoseindirectcontactwithpatients)andhowequipmentgetsintroduced.Understandinghowsyringedriversareusedinpracticecanhelpimprovethedesignofequipment.27semi-structuredinterviewswereconductedacrossacutehospitals,communityhospitalsandhospices(4organisationsintotal).Allparticipatingorganisationsusedthesametypeofsyringedriver.Itwasfoundthatfrontlinestaffneededtoadaptthisequipmenttofitthecircumstancesofuse.Theanalysisprovidedexamplesofthishappeningforaspectsrelatingtotheappearanceofthedevice(bags),accessories(batteries)andsecurity(thelockablebox).Keywords:Interface,UserComputer;Purchasing;MedicalDeviceDesign;PalliativeCare;

IntroductionSyringedriversarewidelyusedforpalliativecare.Thesedevicesarecompactboxesthataretypicallypoweredbyabatteryandcanbeleftunattendedbyhealthcarestaff.Althoughpatientsrelyontheeffectivefunctioningofthesedevicesforpainreliefandhavetointegratethemintotheirlives,andalthoughthedevicesareoftenleftrunningwithoutprofessionaloversight,therehavebeennopriorstudiesofhowtheyareused,orofhowprofessionalsadaptthedevicestoaddresstheirpatients’needsandtoremainsafe.Thispaperreportsonastudyofhowequipmentgetsadapted(e.g.thereconfigurationsthatoccurtosupportuse)andrelatesthistotheprocessofintroducingequipment(purchasing).Thisbuildsonapreviouspaperthatreportshowthoseinvolvedinpurchasingsyringedriversgoaboutevaluatingusability,thechallengesthatarise,andopportunitiesforimprovement(VincentandBlandford,2017).

ThereplacementofoldertypesofambulatorysyringedriverAcrosstheUK,mostpalliativecareprovidersusethesametypeofsyringedriver(forahistorysee(GrahamandClark,2005)).Thedeviceisusedtotreatpatientswhentheycannottakeoralmedication.Itcanbeusedtocontrolsymptomsandprovidepainrelief.Palliativecarecommonlyinvolvestheuseofanambulatorysyringedriver.Thisisbecausepatientsmaybemobilewhilstusingthedevice.Thecurrentambulatorydevicereplacedanolderpieceofequipment(reviewedin(Oliver,1988))thatwaswithdrawnduetoconcernsaboutalackofcontrol,difficultyinuseandpotentialforerror.ThereplacementfollowedthereleaseofaRapidResponseReport(RRR),detailingthepotentialforconfusiontoarisewhensettingtherate.“Whilethemajorityofsyringedriversandpumpsusedinhealthcarehaveratesettingsinmillilitres(ml),someoldertypesofambulatorysyringedrivershaveratesettingsinmillimetres(mm)ofsyringeplungertravel.Thisisnotintuitiveformanyusersandnoteasytocheck.”(NPSA,2010)Althoughtherewasaneedtoreplacetheoldequipment,therewasalimitedchoiceinthemarketplace;sometrustsreportedthattheyhadlittlechoicebuttouseasingletypeoftechnology.Thefocusofthisstudyisonthewaysinwhichtheequipmentwasadaptedforuseacrossmultiplesettings(acutehospitals,communityhospitals,hospicesandhomes),andhowthisrelatestotheoriginalprocessofintroducingit.Thecircumstancessurroundingtheintroductionofthisequipmentprovideanopportunitytolearnhowtheneedsofmultiplelocalorganisationscouldhavebeenmet,basedonthecapabilitiesofagenericpieceoftechnology.

Equipmentreplacementandsocio-technicalsystems(STS)Thesyringedriverwasprovidedwithanagreeddefaultconfiguration(asrecommendedinNPSA,2004).Thismeansthatthefunctionalityandappearanceofthedeviceisthesameregardlessofwherethedeviceisbeingused.However,inthisdomainthenatureofworkischaracterisedbyrelativelysmallgroupsofindividualsactingindependently,indifferentways,acrossdifferentsettings(seeTable1).Thenursessetup,activateandreplenishthedriversindividuallybutarepartofalargerteamthatdevelopsasharedviewonpractice.Forexamplesomenursesmayusethesyringedriverbatterycompartmentlidtoleveroutthebattery.Thisisnotdescribedintheinstructionmanualandreflectsalocalvariationinuse.Suchvariationmaybearesultofaninsightthathasbeensharedwithinagrouporaresponsetoaspecificchallengethatagroupfaces.Forexampleifasyringedriverisusedoutdoorsthenprotectionmaybeaddedtokeepthedevicedry.Ifalargevolumeofsolutionisrequiredthentwodevicesmaybeused.Ifthedeviceisusedwithchildren,aparentmaybeaskedtoperformsimilarcheckstoaclinician(e.g.checkingthatthedeviceisrunning).

Table1:Differentenvironmentsofuse

Environment Useofdevicebyhealthcareprofessional

Customisation

Home Nursevisitshometoset-up/replenishdevice.Devicekeptinalockbox.Deviceleftunattended.Nurseneedstotraveltoattendtopatientordevice.

Deviceusedwithlockbox.Devicesometimesusedwithbag.Staffneedtocheckthelevelofpowerinthebatteryandmaykeepspares.Theappearanceofthedeviceshouldreflectthehomeenvironment.

CommunityHospital

Inthisstudythecommunityhospitalwasusedasahubforthenursesworkinginpatienthomes.

N/A

Hospice Nursecheckspumponaregularbasis.Devicekeptinalockbox.Devicemayormaynotbeattended.

Deviceusedwithlockbox.Devicemaybepositionedunderabedorunderpillow.Thedevicemaybeusedwithadockingstation/externalpowersupply.Thedeviceneedstosupportregularchecks/monitoring.

AcuteHospital Nursecheckspumponaregularbasis.Devicekeptinalockbox.Devicelikelytobeattended.Devicemaybesubstitutedwithanothertype.Devicetrainingprovidedbytrainingstaffworkinginthehospital.

Deviceusedwithlockbox.Deviceispartofacentrallymanagedequipmentlibrary.Devicepositionedatbedside.Thedevicecouldbeusedwithadockingstation/externalpowersupply.Thedeviceneedstosupportregularchecks/monitoring.

Inthiswayteamsfindtheirownwaysofworkinginordertopromoteefficiencyandjobsatisfaction.Optimisationoccursbeyondtheleveloftheindividualbutwithintheleveloftheteam(TristandBamforth,1951;Tristetal.,1963).Thistopicisveryrelevantforhealthcareasthereisadebaterelatingtothebenefitsthatcustomisationprovides(ObradovichandWoods,1996),andlittleattentionhasbeenpaidtohowwellthepracticesofcustomisingfitwithwiderprocessesandcontrols,forexamplethemedicaldeviceregulationsthatseektodefinenormalconditionsofusewhichremainconstantovertime(Randell,2003).Forexample(asinthiscase),theequipmentmaybeintroducedinaverygenericway(e.g.mandatedbyanoverarchingbody);however,socio-technicalsystemstheory(STS)suggeststhattheremaybebenefitsinsmallergroupsadaptingandtakingresponsibilityforit(e.g.theprincipleofresponsibleautonomy(Amble,2013)).Inthehomecareenvironmentthiscouldinvolvecustomisingthedevicetomakeitlookdiscreet(O'Kaneetal.,2015).Inthehospitalcontextequipmentcouldbemodifiedbeyondtheoriginaldesignintent,asperaccountsrelatingtobarcodingsystems(Koppeletal.,2008),alarmsettings(Watsonetal.,2004),physiologicalmonitors(CookandWoods,1996)infusionpumps(ObradovichandWoods,1996)andglucometers(Furnissetal.,2015).Indomainsotherthanhealthcare(e.g.software),theliteraturegenerallypaintsapositivepictureregardingtheroleofadaptationandcustomisation.Adaptationcanbebrokendownintothreecategories.Userscanchangethestructureofworktoaccommodatenewtechnology[fitting],theycanworkaroundwhatthey

seeasmisalignments;andtheycanaugmentworkinlightofnewtechnology(Gasser,1986).Thesebehavioursareseenasavehicleforimprovingpracticeandconfrontingtheproblemsthatcanariseovertime(Mackay,1990;Rogers,1994).Changescanbeacknowledged,fedintodesignandusedtoinformfuturegenerationsoftechnology.Researchisrequiredtounderstandtheprocessof“mutualadaptationbetweentoolandcontext”(BiksonandEveland,1996)asfindingsaffecthowequipmentismanaged(e.g.embracingcustomisationorseekingtoavoidit)andthegeneralapproachtointroduction.Forexample,someofthesebehavioursmightcreateadditionalrisks.ObradovichandWoods(1996)statethatwhenconsideredinabroadercontextadaptationsmaybebrittle,produceunanticipatedsideeffectsorcreatenewpathstofailure.AmorepositiveaccountisprovidedbyCookandWoods(1996)–e.g.“systemtailoringclearlyenhancessomeaspectsofperformance”;however,thereremainsuncertaintyaroundthebenefitthatcustomisationprovidesandhowitshouldbemanaged.Thissituationiscomplicatedbythedifferenttypesofmodificationthatcanoccur.Randell(2003)givesexamplesofdifferenttypesofmedicaldevicecustomisation,including:thoseaimingtoovercomelimitations(e.g.shorttermsolutionssuchasresettingadevice);thoseaimingtoprovideforeaseofuse(penandpaperadaptations);andthosethatchangeproceduresaroundtechnology.Thedifferenttypesofadaptationcanresultinvaryingbenefits,integratewithexistingprocessestovaryingdegreesandmayormaynotbeproductive.Thereisthereforeadegreeofuncertaintyabouthowadaptationoccursandwhatbenefititprovides.Forpalliativecare,therehavebeennoaccountsofthistypeofbehaviour.Thisstudycomplementsexistingunderstandingregardingthesafeandefficientuseofsyringedrivers(Costelloetal.,2008;Cruickshanketal.,2010;McCormacketal.,2001;West,2014);itcanalsoinformtheapproachtothefutureintroductionoftechnology.Forexample,investigationfocusedonaspecifictypeoftechnologycanbeusedtobuildtheoriesoutliningtherelationshipbetweenuser-deviceinteractionsandsystemwideconsequences(forexampletechnologyacceptance)asin(Sharplesetal.,2012).Ifweunderstandthetypesofmodificationthatoccurtosupportproductivitywecandesign,integrateandmanagetechnologyinawaythatsupportspatientsandhealthcarestaff.Aholisticview(understandinginteractionsbetweenpeople,technology,tasks,organisationsandenvironment)helpsprovideasaferandmoreproductiveworkplace(SmithandCarayon,1989)andframeworkssuchasSEIPS(theSystemsEngineeringInitiativeforPatientSafety)showthebenefitofsuchanapproach(Carayon,2009;Carayonetal.,2006;CarayonandSmith,2000;Carayonetal.,2014).Inthecontextofthisstudy,understandingthesebroaderrelationshipspotentiallyimpactsonthetheoriesthatunderpinthedesignofmedicaltechnologywiththeconsequencethatbettertoolscanbeprovided.

Overviewoftheresearchsetting

IntheUK,thehomeenvironmentisthepreferredlocationforendoflifecare.Inthiscasehealthcareprofessionalssetupasyringedriveranditisleftwiththepatientandcheckeddaily.Ifthereareanyproblemswiththedevicethenthepatientorfamilymembercancontactanurse.Thesyringedrivercanalsobeusedinanin-patientsetting(forexamplewithinahospiceorcommunityhospital),assummarisedinTable1.Inthesecasesthedrivercanbecheckedatregularintervals(forexampleeveryhouroreveryfourhours);thefrequencydependsonthetypeofhospitalandwardinwhichthetreatmentisbeingadministered.Ifusedinanacutehospital,thearrangementsaresimilar;however,managementofthedeviceoverlapswiththewiderprocessinthehospital(e.g.managedaspartofacentralisedequipmentlibrary).Thesedifferentlocationsprovidecontrastingfocusesofstudy,andmakeitmorelikelythatadegreeofcustomisationwillberequireddependentonthelocation(seeTable1).Ifastandardpieceofequipmentisintroducedthenitcanbehardtosatisfyuserneedsacrossallofthesedifferentcontexts(e.g.,shoulditbemadetolooklikeapieceofmedicalequipmentorashoulditbedesignedtoblendintothehomeenvironment)?Theneedforcustomisationasdefinedisthereforeanimportanttopicforinvestigation;ononehandlimitingcustomisationofferspotentialsafetybenefits(controlandconsistency),ontheotherhanditrisksprovidingatoolthatdoesnotmeettheneedsofpatientsandhealthcareprofessionals.

MethodsAqualitativeinterviewstudyinvolvingNHSstaffwasconductedbasedonthefollowingprocedure.

ProcedureThestudyinvolvedsemi-structuredinterviews(27participantsacrossanacutehospital,acommunityhospital,ahospiceandatrustoffice[forcommunitycare]).Acutehospitalsandcommunityhospitalsaredifferentintermsofthesizeofthefacility(communityhospitalsaresmaller),rangeofproceduresthatcanoccurandwayinwhichequipmentismanaged.ParticipantsacrossmultiplesiteswerecontactedviaaregionalClinicalResearchNetwork(CRN)andwereapproachedinparallel.Allinterviewsfocusedontheintroductionanduseoftheaforementionedsyringedriver,withtheaimofbetterunderstandingtheirworkpractices.Datawereanalysedusingthematicanalysis,aqualitativemethoddesignedtosupporttheidentification,analysisandreportingofpatterns(themes)(BraunandClarke,2006).Themethodwaschosen,asitisindependentoftheoryandoffersaflexibleandaccessibleapproachtotheanalysisofqualitativedata.Ethicalpermissionwasobtainedviaauniversitydepartmentalresearchethicscommittee.AdditionalpermissionswereobtainedaspertheHealthResearchAuthority(HRA)processforaqualitativestudyinvolvingstaffintheUKNationalHealthService(i.e.researchgovernancewasgrantedbythehealthcaretrustsinvolvedinthestudy).Alldatawereanonymised.Thestudywasbasedononeoftwotopicguides,suchthatquestionswerechosenbasedonthecircumstancesoftheparticipant(Table2).Wherepossible,theyweretailoredtoaparticipant,bothintermsofthetopicguidethatwaschosenandthedecisiontoomitquestionsthatwerenotrelevant.Thetopicguidewaschosenpriortotheinterviewbasedontheextenttowhichtheparticipanthadbeeninvolvedintheintroductionorpurchasingofthesyringedriver.Foroneguide(purchasers),interviewsaddressed7topics,basedaroundtheequipmentlifecycle,withanemphasisonevaluatingequipmentduringpurchasing(Table3).Fortheotherguide(deviceusers),theinterviewsaddressed5topics;lessemphasiswasplacedonthepurchasingofequipmentandmoreontheexperienceofuse(Table4).Twotopicguideswerenecessaryasnotalluserswereinvolvedinpurchasing.Theresultsreportedinthispaperdrawmainlyontheinterviewsconductedusingthetopicguidefordeviceusers.Bothtopicguidesaimedtobalancetheneedforbrevitywhilstfocusingpotentialinsight.Theguidescontainedadefaultplanfortheinterviews,buttopicscouldbecoveredinadifferentorder,dependingonhowparticipantsresponded.

Informedconsentwascollectedfromparticipants.Allparticipantsagreedtointerviewsbeingaudiorecorded.Theaudiorecorderwasclearlyvisibletoparticipantsduringinterviews.Picturesofequipmentoraccessoriesweretakenwithpermissionofthosewhowereinvolved.Table2:Participants

Profile Topicguide

Organisation Profile Involvementinpurchasing

1 Deviceusers

Hospice Communitypractitioner(teamlead)

L

2 Deviceusers

Hospice Staffnurse L

3 Deviceusers

Hospice Districtnurse L

4 Deviceusers

Hospice Hospicemanager L

5 Deviceusers

Hospice Staffnurse L

6 Deviceusers

Hospice Staffnurse L

7 Deviceusers

Hospice Staffnurse L

8 Deviceusers

Communityhospital Clinicalnursespecialist

L

9 Deviceusers

Communityhospital Clinicalnursespecialist

L

10 Deviceusers

Communityhospital Clinicalnursespecialist

M

11 Purchasers Communityhospital Clinicalnursespecialist

H

12 Deviceusers

Communityhospital Nurse L

13 Deviceusers

Communityhospital Nurse-teamlead L

14 Deviceusers

Communityhospital Macmillannurse M

15 Deviceusers

Communityhospital Assistantpractitioner M

16 Deviceusers

Communityhospital Macmillannurse L

17 Purchasers Acutehospital Palliativecarenursespecialist

M

18 Purchasers Acutehospital Consultantforpalliativecare

H

19 Deviceusers

Acutehospital Medicaldeviceeducator

M

20 Deviceusers

Acutehospital Chargenurse M

21 Deviceusers

Acutehospital Staffnurse;wardmanager

M

22 Deviceusers

Acutehospital Staffnurse L

23 Deviceusers

Acutehospital Nursegeneralmedicalward

M

Profile Topicguide

Organisation Profile Involvementinpurchasing

24 Purchasers Acutehospital Palliativecarespecialist

H

25 Purchasers Trust(communityrole)

End-of-lifecarefacilitator

H

26 Deviceusers

Trust(communityrole)

Endoflifecarefacilitator

M

27 Deviceusers

Trust(communityrole)

Pharmaceuticalmedicinesinformation,educationandtraining

M

NOTE:Involvementinpurchasing:L=Low:verylittleornoinvolvement,M=Medium:limitedinvolvement(e.g.providingfeedback),H=High:substantialinvolvement.

Table3:Interviewtopicsforthoseinvolvedinpurchasing

Topic Description RepresentativequestionT1:PersonalBackground

Intervieweeroleandresponsibility.

Whatisyourjob,whatdoesitinvolve,howlonghaveyoubeendoingitforandwhatisyourbackground/experience?

T2:ExamplePurchasingProject

Examplepurchasingprojectincluding,trigger,whowasinvolved,intendeduser,needfornewequipment.

Iwouldlikeyoutotellmeaboutarecentpurchasingprojectrelatingtoaninfusiondevice.[promptswherenecessary]

T3:Process

Awareness,interpretation,utilityandrelevanceofpurchasingguidelines,processandauthority.

Didyoufollowanagreedprocess?

T4:BudgetandSelection

Cost,leasing,purchasingoptions.

Whatbudgetwastheequipmentpurchasedonandwhy?

T5:AdviceonEquipmentInteractivity

Awarenessofsourcesofsupportredeviceinteractivity.

Whodidyougotoforadviceonthesuitabilityoftheequipment?

T6:IntroductionofEquipment

Phasedvincrementalintroduction,lengthofprocess.

Wasthereaphasedintroductionoftheequipmentordiditgetdeployedinonego?

T7:Agreement,ReconciliationandExpectations

Reachingaconsensus,trade-offs,outcomevexpectation,whatdid/didnotworkwell.

Dideveryoneagreeonyourchosensolution?

Table4:Interviewtopicsforthoseaffectedbypurchasingdecisionsoninfusiondevices(i.e.,users)

Topic Description RepresentativequestionT1:PersonalBackground

Intervieweeroleandresponsibility.

Whatisyourjob,whatdoesitinvolve,howlonghaveyoubeendoingitforandwhatisyourbackground/experience?

T2:DevicesUsed

Exampleofaninfusiondevicethattheyused;namingconventions;contextofuse;alternativedevices.

Iwouldlikeyoutotellmeaboutthetypesofinfusiondevicethatyouuse.

T3:InvolvementinPurchasing

Experiencesofbeinginvolvedinthepurchasingoftheinfusiondevice,and/orrecollectionofintroduction.

Wereyouinvolvedinthepurchasing/selectionofthedevice?Ifsopleasedescribewhathappened?

T4:SuitabilityofEquipment.

Likes/dislikes,needs,issues,comparisonswithotherequipment.

Isit[thedevice]suitableforthejobthatyouaredoing?

T5:NetworksandAdvice

Awarenessofsourcesofsupportandadvice;influencesonselection.

Whowouldyougotoforadviceonthedevice?

Codingprocess

Analysiswasconductedafterallinterviewswerecomplete.DatafrominterviewsweretranscribedandloadedintoATLAS.ti(ScientificSoftwareDevelopmentGmbH).Atlas.tiisqualitativedataanalysissoftware.Transcriptsaresystematicallyanalysedtouncoverthephenomenathatarecontainedwithindata.Thisoccursthroughaprocessofcodingandannotationwheretheinterviewtranscriptsarestudiedandsectionsofcontentlabelled(coded)inordertodeterminerelationshipsandthemes.Thesoftwaresupportsthematicanalysis(BraunandClarke,2006),anapproachchosenbecauseitbalancestheneedforrigourwithflexibilitytoallowforarangeofpatternsandphenomenatoemerge.Thematicanalysishasbeensuccessfullyusedtoaccountforphenomenaunderpinningmedicaldevicedesign,development,purchasinganduse(e.g.(Cafazzoetal.,2012;Moneyetal.,2011;Vincentetal.,2014));wewereexpectingtheanalysistoprovideasimilardegreeofinsightinthiscase.Aspartofthethematicanalysis,thefirstauthorconductedaprocessofinductivecoding.Inductivecodingisaprocessthatinvolveslabellingpartsofthetranscript(typicallyoneortwosentences)withaheadingsuchas“training”.Theselabels(orcodes)arecombinedtoformpatternsofresponseormeaning.Thismeansthatthefindingsemergedfromthedata–i.e.therewasnopre-conceivedhypothesis.Overprogressiveinterviews,thecodeswerecombined,revisedandsimplified(asinphasethreeof(BraunandClarke,2006)).Transcriptswereanalysedsuccessivelyintheorderoftheinterviews.Ameasureofthenumberofcodesgeneratedatvaryingpointsintheanalysiswastaken(seesupplementarydata).Thisdeterminedthedegreetowhichthecodingsetwascomplete.Forexample,iftheprocessofreadingatranscriptgeneratednonewinsightthennonewcodeswouldbeproduced.Monitoringthenumberofcodesenabledconsiderationofthecostofadditionalanalysisversustheutilityofthelikelyinsight.Whentheanalysiswascomplete84codeshadbeendefined.Thegenerationofnewcodesreachedaplateaufrominterview17onwards(27transcriptswereanalysed),givingconfidencethatsaturationhadbeenreached.Thisisinlinewithotherstudies(Guestetal.,2006).

ResultsInallcases,thesyringedriverhadbeenusedforsometime(morethanayear).Duetothevariedcontextsinwhichthedevicewasused,therehadbeenaneedtotailorthedeviceaccordingtolocalcircumstances.Theintroductionofagenerictechnologycouldonlygosofarinanticipatingtheneedsofthoseworkingindifferentenvironments(home,hospice,communityhospital,acutehospital).Therewasaneedtorespondtothedifferentenvironmentsinwhichthedevicewasusedandadjustaccordingly.Thiswasunderthecontrolofthefrontlinestaff.Threethemesemerged;theyrelatedtoaprocessofcustomisation

inwhichstaffmodifiedtheappearanceofthedevice(e.g.byusingbagsorpillowstodisguisethedevice),selectiveuseofcertainaccessories(e.g.batteriesandsyringes)anddevicesecurity(usewithinalockbox).Resultsarediscussedintermsoftheirimpactonthewaythatequipmentisintroducedandmanaged.AssociatedquotationsareprovidedinTable5(indexedbyanOBS[observation]referenceasprovidedinthemaintext).

TheuseofbagsandpillowstodisguisethedeviceParticipantsweresensitivetothereactionofthepatient,friendsandfamilytothesightofthesyringedriver.Staffreportedtheirconcernsthatotherswouldthinkthatbyprovidingasyringedriverendoflifewasgoingtooccursoon.Theappearanceofthedevicewasbeingchangedordisguised.Thiscouldoccurbyplacingitinacustommadebagorbyhidingitinotherways.Thisvarieddependentonthelocationandcircumstancesbutwasobservedacrossmultiplesites.Forexample,ifusedinanin-patient(hospital)setting,staffconcealedthedeviceordisguiseditunderapillowsothatitdidnotupsetvisitorsorremindthepatientoftheirtreatment.Inthiscasethepatientwasgenerallybedbound.Staffreportedtheneedforquietanddiscreetequipment,withthecaveatthatthepatientdidnotforgetthattheywereattachedtothedevice.Somepatientswouldusethedeviceinhospitalwhilstmobile.Inthiscasestaffdisguiseditbyplacingitinadisposablebagwhichmatchedthepatient’sclothing.Thiscouldhelpconcealthedeviceandavoidmakingitapparenttofamilyandfriends.Anotheroptionincludingplacingthedeviceinadressinggown;however,thesizeofthelockboxcouldpreventthis.Inbothcasesstaffdidnotbelievethatitwaspossibletousethemanufacturersuppliedbag(Figure),duetodifficultiesinkeepingitclean.Thebagwasseentobeincompatiblewithcleaningprocessesordeemedas“singleuse”.

Figure1:Thebagsuppliedbythemanufacturer(left)andtheremadebag(centreandright).Seealsohttp://www.webcitation.org/6kJwikvNl

Inthehomeenvironmentthebagsusedtocarrytheequipmenthadbeenreplacedbycustom-madealternatives.Inthisenvironmentitwasmoreusualforpeopletowalkaroundwhilstcarryingthedevice.Thenewbagswerestyledinadifferentwayandlookedmoreattractive(Figure-centreandright).Theywereproducedbyvolunteersratherthanbeingpurchased.Charitieswerepreparedtocreatethebagsforfreeandtheycouldbepersonalisedinawaythatwasn’tpossiblewiththemanufacturersuppliedbags(OBS1).Staffhadtakenownershipofthelimitationsoftheexistingbag(whichtheyhadrestrictednumbersof,couldnotwash,andcouldnotreliablylocate).Theyhadworkedwithpatientsandcommunitygroupstomaketheirownbags.Thebagstookvaryingforms.Theyalsoappropriateditemslikehandbagsanddrawstringbagstoprovideadegreeoffamiliarityandmakethedevicefitwithpreferenceandlifestyle.Theconversesituationwaswherefactorsoutsidethecontrolofthenursingstaffwereimpactingtheappearanceoftheequipment.Forexample,staffmentionedthattheylikedthefactthatthenewsyringedriverwasdiscreet.Theycontrastedtheirexperiencewithitwithtimeswhentheyunexpectedlyencounteredequipmentthatwasnotdiscreet.Forexample,inthehospicecontext,staffreportedtheirconcernsaboutpatientsarrivingwithlargerbulkysyringedrivers,ofthetypeusedinahospitalenvironment.Oneparticipantreferredtothismachineasa“monster”(OBS2).

SelectiveuseofbatteriesandsyringesThedevicewasusedwithmultipleaccessoriesincluding:alockablebox(lockbox)-(Figure),keys,batteries,drugs,syringes,lines,wipesandneedles.Inthehomecarecontexttheseitemswerekeptinabagthatwaslocatedneartothesyringedriver.Adaptationswereidentifiedrelatingtotheuseoftheseaccessories,forexamplethebatteriesusedtopowerthedeviceandthesyringesusedtodispensedrugs.

Figure2:Lockboxusedtohousethedevice

Thechoiceofbatterywasimportantinthatifabatterywasofpoorqualityitwouldrunoutrapidly,thedevicewouldalarmandeventuallystop.Thiswouldcausethetreatmenttoendearlyandrequirestafftoattend.Generallyspeaking,batterieswouldlastforthreedaysandtheywerereplacedwellaheadoftime.Thelevelofpowerwascheckedpriortostartingthedevice.Howevertherewereavarietyofbatteriesinuseandtheperformanceofthebatterywashardtopredict(OBS3).Givenaconcernaboutthepotentialforthebatterytorunout,staffhadcompensatedbyadaptingandsupplementingtheirroutine.Inoneunusualcase,theyhadaskedthepatienttohelpbygettingthemtochangethebatterythemselves(OBS4).Otherbehavioursincludedstaffcarryingsparebatterieswiththemandkeepinguptothreesparebatteriesintheaccessorycase.Inthehospiceenvironment,theyhadaccesstoalocalsupplyofbatteriesandwoulddifferentiatebetween“good”batteriesandothersbasedonappearanceandmanufacturername.Inthiscase,asupplyofinferiorbatterieshadconfusedthesituation(OBS5;OBS6).Asimilarsituationwasobservedrelatingtoothercomponents.Therewererestrictionsonthetypesofsyringethatcouldbeusedwiththedevice.Forexample,a50mLsyringewouldnotfitintothelockbox.Usingsuchasyringecouldbepreferableasitprovidedextradiluent,whichwasgenerallyintheinterestofthepatient.Itwasnotpossibletocombinethissyringewiththedevicewhilstusingalockbox,sothistypeofsyringewasnotused.Staffsuggestedthatwhatwaspossiblewiththelockboxwasquiterestrictive.Forexamplesomestaffthoughtthatnothinglargerthana30mLsyringecouldbeused(OBS7).Similarconstraintsoccurredintermsofthepositioningofthesyringe.Forexample,ifa30mLsyringewasloadedinacertainwaythenthelockboxwouldnotcloseorthedevicewouldalarm.Thiscouldoccurifthecollarofthesyringewasnotatthecorrectangle(OBS8).Inthiscasetrainingandwordofmouthhadallowedstafftoadaptthewaythattheysetupthedevicetostopthisfrom

happening.Forexample,staffreportedcarefullycheckingthepositionofthesyringepriortoclosingthebox.

SecurityofthedeviceandusewithalockboxThesyringedriverthatisbeingusedbythenursesincludescontrolsdesignedtostopunauthorisedaccessandtampering.Thepreviouspieceofequipmenthadtypicallybeenuncontrolled,inthattheentirecontentsofthesyringecouldbedispensedasaresultoftampering(althoughtherewasanoptiontousethedevicewithalockbox).Thatdevicedidnothaveacomprehensiveeventlog(wayofrecordingdeviceactionssuchasachangeinrate).Thismeantthatifadevicewasemptiedinonegoitcouldbeimpossibletofullyunderstandwhathadhappened.Oneofthereasonsforintroducingthereplacementpieceofequipmentandaccompanyinglockboxwasconcernsaboutthislackofcontrol(OBS9).Unlikethepreviousequipment,thenewequipmentiscontainedwithinalockbox(Figure).Thelockboxprovidesadegreeofsecurityinthatitmakesitdifficultforotherstoaccessthedrugscontainedwithinthesyringedriverortamperwiththesyringe.Thedownsideofthelockboxisthatitmakesthedevicebulkyandcouldcomplicatelegitimateaccess(OBS10;OBS11).Atthesametimetheboxeswerebeingdroppedandbecomingcracked(OBS12).Staffsuggestedaneedtomaketheboxsofterandmorerobust(likeamobilephonecase).Thiswasbecausetheboxitselfcouldbeplacedunderabedpillow(toconcealthecombinationofdeviceandbox).Evenwhenthelockboxesworkedasdesigned,thereweredifferencesinapproachtostoringthekeyusedtoopenthelockbox.Itcouldbekeptneartothedevice,storedpersonally,and/orstoredcentrally(e.g.withotherwardkeysorinakeybox).Thesituationwasparticularlycomplicatedinthehomeenvironment.Whenusedinthehomecontext,staffwouldtypicallyleavethekeywiththedevicebuthideitinaninaccessibleplace.Whenthedevicehadbeenintroduced,itwasdecidedthatassparedrugswerekeptinthehome,trustwasrequired.Thistrustcouldbereflectedinthedecisiontoleavethekeywiththedevice.Ifstaffwereconcernedaboutthepotentialfordiversionofdrugs,oruncontrolleduseofthedriver,theycouldkeepthekeyontheirperson.Theycouldalsochoosenottoallowcaretooccurinthehome(OBS13).Itwaseasiertokeepthekeynearthedeviceratherthanwithamemberofstaffasmultiplepeoplewouldbeinvolvedinpatientcare.Bystoringakeywiththedevicetherewasadegreeofflexibilityinthatifotherstaffneededtoopenthedevice,theycoulddoso.Therefore,inthehomecarecontextstaffwereleavingthekeywiththedevice(mostofthetime).Theyhidthekeyinavarietyofplaces.Theycouldsometimeslosethekey(OBS14).Tocompensateforthisinonecasetwokeyswerehidden.Keyswerealsohiddeninaplacewhereitwasimpossibleforamemberofstaffnottodiscoverthem(e.g.discoveryofthekeywasimplicitintheprocedureforsettingupthedevice).

Sparekeyswerealsokeptinacentrallocation.Somekeyswereadaptedusingcolouredcaps,tomakethemasvisibleaspossible.Themeaningplacedinthekeywasthereforevariableandtherewasabalancetobeachievedbetweentheprotectionthatthelockprovidedandconcernsaboutimpedingcare.Theboxthereforeprovidedanimportantfunction,butaswiththebatteriesandsyringes,therehadbeenaneedforadaptation.

Table5:Quotationsfrominterviews.Participantnumbersareincludedaftereachquotation-(seeTable2).Recommendation Quotation REF1Providecustommadebag. “theycancarryitinabagwhichisreallygood…

andwhatbag?ummmpatientstendtocomeupwiththeirown,theytendtopersonaliseitreally,wehavehadquilters,wehavehadlikecraftpeople,thathavemadeusbags,ummandthepatientsloveit…”(26)

OBS1

2Makethedevicesmallandattractive.

“TobehonestatthemomentIcan’tthinkofthename,theywerejustmonsters.Weactuallyhadonesenthomeoverherebymistakeoncewithapatientfrom[hospitalname].Andeverybodyherewaspanickingbecausetheydidn’tknowwhatthismonsterwasorhowtheycouldturnitoff"(5)

OBS2

3Improvebatterytechnologyandincludechecksandcontrolsthatavoidtheneedforreplacementofthebatteryduringtreatment.

“Yesitwillstartbleepingbeforethebatteryrunsoutandsayssomethinglikebatterylow.Butwealwaystrywhenweleavetomakesurethatthere'senoughbatterytolastuntilthenextvisit.Butsometimesitwilljustdrainfornoreason.”(3)“Iftheyringupandsay,ohyouknow,itsaysbatterieslow,theycansometimeschangeitthemselves.Imean,theladywe'vegothasbeenonitforalongtime.Soitdiddothatandshewasabletochangethebatteryherself…”(3)“…batteries,Imeanyouneedagoodbatteryinit.YouknowIthinktherehasbeenaninstancewheretheyboughtthecheaperbatteries.Welltheyrunout[ofpower]innotime.”(5)“Sothennowwe’vehadamemosayingalwaysusethe[batterysupplier]onesthatarespecificallyboughtforit…”(7)

OBS3-OBS6

4Provideforcompatibilityacrosscommonlyusedaccessories(syringes);providefeedbackattimeofsetup;providereliableattachmentforthesyringe.

“…30.Itonlylikesthiskindofsyringe.Anyothersyringe,itdoesn’treallyliketorecogniseit.Andinmyexperience,ifyouputadifferentoneinandyougetittogo;italwaysbleepsatyouaboutanhourlater.But,it’snotdifficult.”(1)

OBS7

5Provideforcompatibilityacrosscommonlyusedaccessories(boxes).

“butitistryingtofititintheboxandsometimeswhenyouputtheliddown,thecollargetsdisplacedandthealarmwillgooff”(26)

OBS8

6Controlthecontentsofthedevice.

“whenIfirststartedbackin2008wehadthe…the[pump]hadjustbeenremovedbecauseofanincidentthatjusthappened.Therewassomesuggestionthatthefamilyhadtamperedwiththedeviceandbecauseofthat,becausetheyweren’tinlockableboxes,theywereremoved”(18)

OBS9

Recommendation Quotation REF7Whenthedeviceisusedwithinalockbox,ensurethatthedesignremainsappropriateforanambulatorycontext.

“Itisjustbasicallytheyfinditalittlebitbulkycarryingitaround…Especially[the]lockbox…”(14)

OBS10

8Ensurethemeanstoopen/shutthelockboxisreadilyavailableforthosewhorequireaccess.

“Thisistheplastic,there’salockablecase,whichisgoodinoneway,butofcourse,youknow,youhaveconcernsaboutwhere’sthekey.Soinmyparticulararea,weboughtthedifferentcolouredtagstoputonthekeys,likeorange,andwesaidwe’dkeepitinthefrontofthe[location].Otherareashaveactuallytapedittothe[location].It’smakingsurethateverybodyknowswherethiskeyis.”(26)

OBS11

9Ifthedeviceisusedwithaccessoriessuchasalockboxmakesurethattheyaresoftandrobustwhilstatthesametimeprovidingforquickandeasyaccess.

“…apartfromthecasinglikeIsaid,theplasticcasing,theoutercasingisquitebrittleandsometimesyouhavealittlestrugglewiththekeystogetthem…Toopenitproperly,youknowyou’refightingagainstitandtheysnaptheinnerlittleplasticbitthatlinksit,closesit.Thosewill...snapoff...Yes,andifsomeone,ifapatientdropsthem,whichtheywilldo,ifthey’refidgetingabouttheywilldropit,thatwilljustbreak.”(5)

OBS12

10Foradevicethatcontainssecuritycontrolsconsiderhowsuchcontrolswillworkinthehomeenvironment(e.g.whenthedeviceisleftalone).

“weusuallyhaveakeyandaspareinthebagandIcan’trememberifweeverhadakeyintheoffice,orwhetherwejustleftthemwiththepatient.Buttheyareleftinthebagandgenerallyspeakingthepatientsdon’ttouchthebagbecausethat’sgotthedrugsinit,andthekeyandasparebattery.”(7)

OBS13

11Foradevicethatcontainssecuritycontrolsprovidetheoptiontooverridethesystemineventofamishap.

“Imeanthelockboxoccasionallycausesaproblemifwelosethekey”(16)

OBS14

DiscussionInthecontextsthatwereobservedonlyonetypeofdeviceisbeingused.Thisisbecausetheselectionprocessconstrainsthetypeofdevicethatcanbepurchased.InordertobuythedeviceithastobeCEmarkedandthemanufacturer/distributorneedstogothroughanumberofchecks.Aseriesofevaluationcriteriaareappliedandthedeviceisexcludedifitfailscertainchecks.Theculminationoftheaboveisthatallcareprovidersusethesamedevice(see(VincentandBlandford,2017)foradetailedexplanation).Despiteasinglemakeofsyringedriverbeingusedacrosspalliativecare,adaptationhasoccurredtoovercomearangeofissues.Thishasimplicationsforthedesignanduseofmedicaltechnology.Ithighlightstheneedforconstantreviewandcustomisation.Forprocurementthismeansthatratherthanconsideringtheintroductionofequipmentatasinglepointintime,analysisandmonitoringneedstooccuracrossthelifecycle.Inhealthcaretheconceptofadaptation(orworkaround)iscommonlyregardednegatively(Halbesleben,2010).Itcreatesatensionbetweenanoutlookthatdescribessuchbehaviourasan"error","violation"or"deviation"versusonethatviewssuchbehavioursas"innovations"or"improvisations"(Debonoetal.,2013).Giventhistension,therearedifferentperspectivesonthebenefitthatadaptationprovides.RandelltouchesonthisinherstudyofalarmsettingsinanIntensiveCareUnit(ICU)(Randell,2003).Sheexploresthereasonsbehindadaptationsandwhytheymightnotbeviewedpositively.Inparticular,thedesign,manufactureanduseofmedicalequipmentisregulatedandtheproceduressurroundingequipmentdefined;changingthebehaviourofequipmentinalocalcontextrisksviolatingassumptionsmadeduringdesign,where“normal”conditionsofusearedefined.Notusingtechnologyinthisway(implicitinadaptation),mayimpactthesafetyandperformanceofasystem.Someofthetimethisisbeneficial(i.e.providingforflexibility);atothertimesitpresentsrisk,eitherwithintheimmediatecontextormorebroadlywithinthesystem.Similarissuesariseinmanymedicalcontexts.Thismeansthatthetraditionalapproachofoptimisingworkflowacrossasystemcanonlygosofarinestablishingefficiency,effectivenessandsatisfaction.ModelssuchasSEIPSrecognisetheneedfor"jobbalance"i.e.consideringinteractionsbetweenpeople,organisations,technology,tasksandtheenvironment.ThemedicaldevicedesignmodelbySharples(2012)includesexamplesof“adjustability”asafacilitator(ofpositiveconsequences);however,theregulatednatureofmedicaldevicedevelopmentlimitstheextenttowhichthiscanoccur(VincentandAmalberti,2016).Thisstudyofsyringedriverusehighlightsaneedforcustomisationandadaptation.Itreflectsthetensionbetweenatopdownapproachtoequipmentmanagement(i.e.asingletypeofequipmentconstrainsthewayinwhichstaff

work)andasocio-technicalapproachwheretheformoftechnologycanbevariable(i.e.jointoptimisationbetweengroups,toolsandtheenvironment).Elsewhere,thesedifferencesarereferredtoas“workasimagined”and“workasdone”(Blandfordetal.,2014;Hollnagel,2015).Thefirstapproachisadesignedorganisationwhererules,regulationsandstructuresreducetheneedforhumanjudgment.Inthiscasethereareadvantagestoasyringedriverbeinginflexible.Thesecondapproachallowstheorganisationtoco-evolvewithtechnologytoreachajointlyoptimisedsolution(inwhichcasethereisabenefittotechnologyprovidingforadegreeofflexibility).Thestudyreportedhereshowsthatastandardisedandmandatedtoolfailstodeliveragainsttheneedofuserswhentheirneedsvaryconsiderably.Forthisreasonthesecondapproachisrequired.

ConclusionThesefindingsemphasisetheneedforafluidrelationshipbetweentechnologyandorganisation.Inthedomainthatwasstudied,likeothers,adaptationwashappeninginacollaborativesense.Thesametechnology,ostensiblybeingusedforthesamepurpose–i.e.,palliativecare–wasadapteddifferentiallyinthedifferentcontextsofuse;thishighlightstheimportanceofthesocialcircumstancessurroundingtechnologyuse,asdiscussedbyBarley(1986).Inthisview,technologyistreatedasasocialobjectratherthanaphysicalone,andisconceptualisedasaprocessratherthananentity.Thismeansthatadaptationsarerecognisedinalocalcontextandthereisadrivetounderstandrepercussionsacrossthebroadersystem(bothsocialandtechnical).Asdiscussedabove,suchadaptivebehaviourscomewithbothrisksandbenefits,buttheyareanecessarycomponentofthesuccessfulintroductionoftechnology.Thisstudyhasparticularlyhighlightedmanyofthechallengesinherentinintroducingasafety-criticalmedicaldeviceintothehomecontext,wherethedignity,comfortandsafetyofthepatientallneedtobeconsidered,andwheretrainedprofessionalsarenotimmediatelyonhandtooverseeuseandinterveneifanythinguntowardoccurs.Theadaptationspresentedabovehighlightanopportunitytoreviewthevariousneedsofpatients,familiesandprofessionalsacrosscontexts,butparticularlyinthelesscontrolledcontextofthepatient’shome.Thiswillbeofgrowingimportanceasmorecareshiftstolessmedicalisedcontexts(e.g.,fromhospitaltohome).

ConflictofInterestStatementEmployment:ThefirstauthoriscurrentlyemployedbyproductandservicedesigninnovationconsultancyPDDGroupLtd.

AcknowledgmentsWewouldliketothankallofthosewhohavebeeninvolvedintheresearchpresentedinthispaper,includingallstudyparticipantsandresearchnurses.ThisstudywasconductedwithintheCHI+MEDproject,supportedbytheUKEngineeringandPhysicalSciencesResearchCouncil[EP/G059063/1].References

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Supplementarydata

Nameofcode Occurrences Category

Organisationandexperience(adviceandsupport)

76 Generalbackground

[Syringedriver]isgood/easytouse 54 GeneralbackgroundOverlapwithotherequipment 47 SecurityofthedeviceLockboxandlockboxissues 40 SecurityofthedeviceTraining 37 -Whatthesyringedriverisusedfor 31 GeneralbackgroundInvolvementinpurchasing 29 -Transitions 25 -Frequencyofuse 23 GeneralbackgroundKeys,locksandkeypadlocks 22 SecurityofthedeviceBatteries 19 Deviceand

accessoriesOverlapwithprescribingpractice 18 GeneralbackgroundPatient/familyperspective 16 DeviceandpatientSizeandweight 14 DeviceandpatientSyringes 14 Deviceand

accessoriesPortabilityandbags 13 Deviceandpatient

Whatthe[syringedriver]iscalled 13 GeneralbackgroundAesthetics 11 DeviceandpatientTriallingofequipment 10 -Workflow 10 GeneralbackgroundAlarms 9 DeviceandpatientHomecareversushospitalcare 9 GeneralbackgroundSafety 9 GeneralbackgroundOverlapwithpaperbasedsystems 8 -Trackingofequipment 8 -Cost 7 -Needforreliability 7 DeviceandpatientResource 7 -Checking 6 -Connectionswiththefrontline 6 GeneralbackgroundOnlythe[syringedriver]isavailable 6 -Otheraccessories 6 Deviceand

accessoriesAccuracy 5 -Notinvolvedinpurchasing 5 -Encouragedtoadopt 4 -Oldequipmentworse 4 GeneralbackgroundReasonsforprocurement 4 GeneralbackgroundResistancetochange 4 -Systems 4 -Unpredictability 4 -Inflexibility 3 -Quickreferenceguide/manual 3 -Timescalesonintroduction 3 -Unexpectedbehaviourofdevice 3 -Availabilityofequipment 2 -Calibration/servicing 2 -Devicelog 2 -Discreteequipment 2 DeviceandpatientEnvironmentalconsiderations 2 -Improvements 2 -Multidisciplinaryteams 2 -Offlabeluse 2 -Reliability 2 -Safetyvusability 2 -Thepumpgetsdropped 2 -Useofinstructionmanual/documentation

2 -

Adviceandsupport 1 -Avoidingcomplexity 1 -Committees 1 -Consent 1 -Continuity 1 -Costvpreference 1 -Despiteissuesstaffliketheequipment 1 -Fiddly 1 -Flawedassumptions 1 -Flexibility 1 -Forcedintroduction 1 -Growingresponsibilityofnurses 1 -Informationthatthepumpshouldprovide

1 -

Lackofinterest 1 -Lackoftraining 1 -Lettersofrecommendation 1 -Logs 1 -Misunderstandingregardingfunction 1 -Multiplepumpsforonepatient 1 -Needlefreedevices 1 -Outofhourssupport 1 -Potentialforerror 1 -Purchasingprovidesthewrongstuff 1 -Purchasing-goingbeyondasinglepointintime

1 -

Purchasingbroaderthanequipment 1 -Reducedependencyonmanufacturer 1 -Relationshipwithmanufacturer 1 -Trainerasamediator 1 -