aqc 2016 patient centered survey final...
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AQC2016SurveyResearch
FinalReportofPatientSurveyandAQCMemberSurveyData
October2016
2
UsageGuidelines
Proprietary&Confidential– NoreproductionoftheinformationinthisreportmaybemadewithouttheexpresspriorwrittenconsentofTheAvocaGroup.Allinquiriesandrequestsforconsentforreproductionanduse,includingintegratingelementsofthisreportintotherecipients’ownworkproducts(e.g.,presentations),shouldbedirectedtoLakshmiSundarviaemailatLakshmi.Sundar@theavocagroup.com.
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Introduction:2016AQCSurveyPrograms
Introduction
• The2016AQCSurveyResearchProgramhadtwocomponents– AQC’sfirstPatientSurvey,andanabbreviatedversionoftheannualMemberSurvey.InclusionofthePatientSurveyin2016wasrelatedtoAQC’sobjectivetounderstandclinicalresearchquality,andhowitmightbeimproved,fromtheviewpointofallkeystakeholders.
• TheoverallobjectivesoftheAQCPatientSurveyweretogainanunderstandingof:
– theextenttowhichpatientsperceivethattheirmedicalcareprovidersunderstandvariousaspectsofthepatientexperience,
– patientperceptionsof“quality”andvalueinclinicalresearch,aswellasactionsbyresearchersthatmightpositivelyandnegativelyimpacttheseperceptions,and
– factorsthatdrivepatients’desirestoparticipateandcontinueinclinicaltrials.
• Theobjectiveofthe2016AQCMemberSurveywastoexaminequalitytopicsinamannerthatparalleledthePatientSurvey,aswellastocontinuetofollowMemberperceptionsofkeyqualityindicatorsovertime.
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Methodology:PatientSurvey
Introduction
• ThePatientSurveywasaweb-basedsurveyofadults(≥18yearsold),UnitedStatesresidentswhoself-identifiedas“patients”withanymedicalconditionandwhocouldread,understand,andcompleteaweb-basedsurveyintheEnglishlanguage.Thestudyrecruited582peoplefittingthisdescription.
• PotentialparticipantswerecontactedbyemailusingemailaddressesfromthePMGResearch,PLM(PatientsLikeMe),andCISCRP(CenterforInformationandStudyonClinicalResearchParticipation)databases,aswellastheAQCMembership.Allcontactsweremadebytheoriginatingorganizations;therewasnotransferofemailaddressesoranyotherpotentiallyidentifyingpatientinformationtootherorganizations(includingTheAvocaGroup),aspartofthisresearch,norwasanypotentiallyidentifyinginformationgatheredduringthesurveyprocess.
• Thisminimal-riskresearchprojectwasreviewedbyWIRBandgrantedexemptstatus.
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Methodology:AQCMemberSurvey
Introduction
• TheAQCMembersurveywasaweb-basedsurveyofSponsorandCROAvocaQualityConsortiumMembers.
• Atotalof188respondentscompletedthesurvey,amongkeyaudiencesasfollows:
– 103fromSponsororganizations
– 85fromCROs
• AllsurveyswerecompletedbetweenMarchandJuneof2016.
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CharacteristicsofthePatientSample
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54%
21%
19%6% Married/domesticpartner
Divorced/separated
Single
Widow/widower
Thesamplewaspredominantlyfemale,and82%ofparticipantswereoverage45.Approximatelyhalfofrespondentswerelivinginmarriages/domesticpartnerships,andthevastmajority(84%)residedintheEasternorMidwesternUS.
CharacteristicsofPatientSample:Demographics
13%3%
13%
21%
50%
West,Southwest
Mountain
Midwest
Northeast
Southeast
MaritalStatus
N=491
N=494
73%
27%Female
Male
Sex
3%15%
38%
39%
5% 18to30
31to45
46to60
61to75
76+
N=492
AgeRegionwithintheUS
N=497
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CharacteristicsofPatientSample:MedicalConditions
9%
29%59%
Temporary(expectittogoawaycompletelyatsomepoint)Episodic(comesandgoes)Degenerative(getsworseovertime)Chronic(alwaysthere)butstableDon’tknow
7%12%
17%
34%
29%
None
Itvariesalotovertime
Mild
Moderate
Severe
Don’tknow
Howoftendoyouseethedoctorresponsiblefortreatingyourcondition?
12%
48%20%
9%10% Onceperyearorless
2to4timesperyear
5to12timesperyear
Morethan12timesperyear
Itdepends
Can'trecall
Themajorityofrespondentsreportedchronicordegenerativemedicalconditions,andmostexperiencedmoderateorsevereimpactsontheirlives.Abouttwo-thirdssawtheirtreatingdoctorsbetween2and12timesperyear.
ImpactofMedicalCondition
N=580
TypeofMedicalCondition
N=581
N=582
9
42%
58%
Yes
No
24%
13%
31%
32%Fulltime
Parttime
Retired
No
23%
33%
32%
11% Advanceddegree
Completedcollegedegree
Somecollege
Completedhighschool
Somehighschool
Respondentswerelargelywell-educated,withmorethanhalfpossessingacollegedegree.Approximatelyathirdwereemployed,one-quarterfull-time.Slightlyunderhalfwererelieduponbyfamilymembersfordirectcareorfinancialsupport.
CharacteristicsofPatientSample:EducationandEmployment
Doyouhavefamilymembersforwhomyouprovidecareorfinancialsupport?
HighestLevelofEducation
N=497
N=578
Areyoucurrentlyemployed?
N=581
10
CharacteristicsoftheAQCMemberSample
11
CharacteristicsofAQCMemberSample:Companies
Sponsors103respondentsfrom27Membercompanies
#ofrespondentspercompanyrangedfrom1to11
CROs85respondentsfrom6Membercompanies
#ofrespondentspercompanyrangedfrom5to32
Alexion Horizon
Alnylam Infinity
Amgen MitsubishiTanabePharma
Astellas Novartis
Biogen Pfizer
BoehringerIngelheim Pharmacyclics
BristolMyersSquibb Purdue
CSLBehring Raptor
Cidara Roche
EliLilly SeattleGenetics
Endocyte Shire
GlaxoSmithKline Sunovion
GileadSciences Theravance
Grünenthal
Chiltern
Covance
ICON
INCResearch
PPD
PRA
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Sponsorrespondentsrepresentedcompaniesofvaryingsize,whileCROrespondentswerecomprisedofLargeandMid-sizedCROs.AmajorityofrespondentsfrombothSponsorsandCROsrepresentedcompaniesheadquarteredintheUnitedStates,withtheremainderprimarilyinWesternEurope.
CharacteristicsofAQCMemberSample:CompanySize&Location
78%
19%1%2% UnitedStates
WesternEurope
Japan
Other
Sponsors CROs
41%
15%17%
26%1%
Top20Biopharma($10+Bsales)Top50/Mid-sizedBiopharma($1.0-$9.9Bsales)OtherMid-sizedBiopharma($500-$999Msales)Small/SpecialtyBiopharma(<$500Msales)Other
71%
27%2% UnitedStates
WesternEurope
Japan
Other
67%
33%
LargeCRO($1+Brevenue)
Mid-sizedCRO($100-$999Mrevenue)
Small/SpecialtyCRO(<$100Mrevenue)
Other
N=103
N=103
N=84
N=84
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ThesamplewaslargelycomposedofrespondentsrepresentingtheClinicalDevelopment/Operationsfunctionoftheirorganizations,followedbyQualityAssurance/QualityControl.
CharacteristicsofAQCMemberSample:RespondentRoles
Sponsors CROs
54%
16%
3%
18%7%
ClinicalDevelopment/Operations
Procurement/Outsourcing/VendorManagementRegulatoryAffairs
Medical/Scientific
ExecutiveManagement
QualityAssurance/QualityControl
Other
52%
12%4%7%
19%6%
ClinicalDevelopment/Operations
BusinessDevelopment
AllianceManagement/Partnerships
Medical/Scientific/Regulatory
ExecutiveManagement
QualityAssurance/QualityControl
Other
N=102 N=84
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ApproximatelyhalfofrespondentsfromSponsororganizationsindicatedthattheyutilizeamixoffull-serviceandfunctionaloutsourcingforclinicaldevelopment,followedbyprimarilyusingafunctionalproviderandprimarilyutilizingafull-serviceapproach.
CharacteristicsofAQCMemberSample:OutsourcingModels
19%
23%58%
Primarily(>80%)full-serviceoutsourcing
Primarily(>80%)functionaloutsourcing
Mixoffull-serviceandfunctionaloutsourcing
Sponsors’OutsourcingModels
N=103
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PatientViewsonUnderstandingof
theirConditionsbyHealthcareProviders
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Onaverage,patientswerenotveryimpressedwiththeirhealthcareproviders’understandingofwhatit’sliketobeapatientwiththeirconditions.Meansinthissectionofthesurveyrangedfrom2.9to3.4onascaleof1(understandsnotatall)to5(understandsverywell),andforeachquestion,between26%and39%ofpatientsgavearatingof1or2.
PatientViewsonUnderstandingoftheirConditionsbyProviders
Scaleof1(notatall)to5(verywell).Ifyouseemorethanonehealthcareproviderforyourcondition,andifyouropinionsregardingthemaredifferent,pleaserespondforthehealthcareproviderwhoyouseemostoften.
11%
12%
11%
14%
12%
11%
13%
16%
15%
15%
16%
14%
16%
18%
17%
17%
22%
22%
21%
22%
23%
25%
23%
24%
26%
26%
26%
26%
26%
23%
22%
18%
27%
26%
27%
25%
23%
23%
25%
25%
What’smostimportanttoyouinatreatment
Thesymptomsthatbotheryouthemost
Allofthedifferentkindsofsymptoms
Whatsideeffectsyouexperience
Typeofpain/discomfort
Amountofpain/discomfort
Whatyouworryaboutinatreatment
Worklifeandabilitytomakealiving
1- Notatall 2 3 4 5- Verywell
Mean N
3.4 497
3.4 515
3.4 512
3.3 501
3.3 486
3.3 493
3.3 493
3.2 445
Howwelldoyoubelievethatyourdoctor(s)andnurse(s)understandwhatit’sliketobeapatientwithyourcondition,ineachofthefollowingways?
Slide1of2
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Patientswereonaveragemostlikelytofeelthattheirprovidersunderstoodtheirsymptomsandtreatmentpreferences,butwerelesslikelytoperceivethattheirprovidersunderstoodtheimpactsoftheirconditionsontheirlivesandparticularlyontheirfamilyrelationshipsandabilitytocareforchildren.
PatientViewsonUnderstandingoftheirConditionsbyProviders
15%
17%
14%
20%
17%
20%
19%
24%
19%
15%
18%
17%
20%
19%
19%
14%
22%
25%
26%
18%
21%
20%
24%
28%
24%
23%
24%
17%
18%
21%
19%
20%
20%
20%
18%
27%
23%
21%
19%
15%
Howyourothermedicalconditions(besidesthisone)affectyou
Abilitytoperformbasictasksofliving(hygiene,housework,etc.)
Abilitytotakepartinactivitieswithfriendsandinthecommunity
Howthecostaffectsyou
Howtheinconvenienceordiscomfortaffectsyou
Mentalhealth/emotionalstate(e.g.Happiness,worry,stress)
Relationshipwithyourspouse/partner
Relationshipwithandabilitytocareforyourchildren
1- Notatall 2 3 4 5- Verywell
Howwelldoyoubelievethatyourdoctor(s)andnurse(s)understandwhatit’sliketobeapatientwithyourcondition,ineachofthefollowingways?
Slide2of2
Scaleof1(notatall)to5(verywell).Ifyouseemorethanonehealthcareproviderforyourcondition,andifyouropinionsregardingthemaredifferent,pleaserespondforthehealthcareproviderwhoyouseemostoften.
Mean N
3.2 470
3.2 497
3.1 497
3.1 487
3.1 503
3.0 511
3.0 370
2.9 255
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ThemesinOpen-EndedCommentsPatientViewsonUnderstandingoftheirConditionsbyProviders
• No-onecanrelatetopain/fatigue/symptomslikethis,andtheirimpacts,unlesstheyhaveexperienceditthemselves
• Lackof“vocabulary”and/orself-trackingtoappropriatelyconveyexperiencetoproviders
• Providersaretoobusytotrytounderstandallofthesethings
– Briefvisitsforcepatientstoconveyonly“1or2topsymptoms;”focuson“abilitytoworkformoney”concernsatexpenseof“abilitytoplay”orfamilyconcerns
• Notproviders’jobtounderstandthesethings,notpartofmedicine
• Prescribingpatternsdonottakeintoaccountpatientpreferencesre.tradingasymptomforasideeffectorrisk;donothonortreatmentrefusals
• Doctorsfailtotrackcharts/histories,onlygrasp“what’sgoingonnow”
• Specialistcaremeansthateachdoctoronlyunderstandsonepartofthepatient
• Patientspurposefullydon’tsharethisinformation(seelaterslides)
• Prescribingpatterns(tests,treatments,referrals)demonstratefailuretounderstandlogisticsandstressofgettingcare,i.e.transportationconcerns,financialconcerns,insurancehassles,timeoffofwork
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Onaverage,patientswithchronicconditionsfeltmostunderstoodbytheirproviders.Thosewithdegenerativeconditionsfeltleastunderstoodwhenitcametomostaspectsofdisease,butthosewithepisodicconditionsfeltleastunderstoodwithrespecttoimpactsontheirrelationshipsandabilitytofunctionatwork,athome,andinthecommunity.
PatientViewsonUnderstandingbyProviders:ByTypeofCondition
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell)
Chronicbutstable Degenerative Episodic
What’smostimportanttoyouinatreatment 3.6 3.2 3.3Thesymptomsthatbotheryouthemost* 3.5 3.3 3.4Allofthedifferentkindsofsymptoms 3.5 3.2 3.4Whatsideeffectsyouexperience 3.4 3.2 3.5Typeofpain/discomfort* 3.4 3.1 3.2Amountofpain/discomfort 3.4 3.2 3.3Whatyouworryaboutinatreatment 3.4 3.2 3.2Worklifeandabilitytomakealiving* 3.3 3.2 2.7Howyourothermedicalconditions(besidesthisone)affectyou 3.3 3.0 3.1Abilitytoperformbasictasksofliving(hygiene,housework,etc.)* 3.2 3.2 2.9Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.2 2.9Howthecostaffectsyou 3.2 3.1 3.2Howtheinconvenienceordiscomfortaffectsyou 3.1 3.0 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 3.1 3.1Relationshipwithyourspouse/partner 3.1 2.9 2.7Relationshipwithandabilitytocareforyourchildren* 3.0 3.0 2.3
Nrange= 149-299 70-152 25-47
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyTypeofMedicalCondition(onlycategorieswithN>10)
Note:Highestmeanperrowhighlightedinyellow,lowestinred;*p<.05(unadjustedformultipletests)
20
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Severe Moderate Mild Itvaries None
What’smostimportanttoyouinatreatment 3.3 3.4 3.8 3.6 3.2Thesymptomsthatbotheryouthemost** 3.2 3.4 3.8 3.5 3.2Allofthedifferentkindsofsymptoms** 3.2 3.4 3.9 3.3 3.3Whatsideeffectsyouexperience 3.3 3.3 3.6 3.3 3.2Typeofpain/discomfort 3.2 3.3 3.6 3.4 2.9Amountofpain/discomfort* 3.1 3.3 3.7 3.3 3.0Whatyouworryaboutinatreatment 3.2 3.2 3.5 3.4 3.0Worklifeandabilitytomakealiving 3.3 3.1 3.2 3.0 2.8Howyourothermedicalconditions(besidesthisone)affectyou 3.0 3.2 3.4 3.1 3.2Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.2 3.3 3.2 2.6Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.1 3.2 3.1 2.7Howthecostaffectsyou 3.1 3.0 3.4 3.2 3.2Howtheinconvenienceordiscomfortaffectsyou 3.0 3.0 3.4 3.1 3.0Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 3.0 3.2 3.1 2.7Relationshipwithyourspouse/partner 3.0 2.9 3.4 2.9 2.6Relationshipwithandabilitytocareforyourchildren 2.9 2.9 2.9 3.1 2.4
Nrange= 77-159 87-181 37-80 35-63 18-35
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyImpactofMedicalCondition
Onaverage,patientswithmilddiseaseimpactsfeltmostunderstoodbytheirproviders.Thoseattheextremesofthespectrum– withnoimpactorwithsevereimpact– feltleastunderstoodwhenitcametomostaspectsofdisease.
PatientViewsonUnderstandingbyProviders:ByImpactofCondition
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01(unadjustedformultipletests)
21
Patientswithhigh“touchrates”withtheirdoctorswerenomorelikelytofeelunderstoodthanwerepatientswithlessfrequentcontact.
PatientViewsonUnderstandingbyProviders:ByFrequencyofCare
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell)
Morethan12timesperyear
5to12times
peryear
2to4times
peryear
Onceperyearorless
Itdepends
What’smostimportanttoyouinatreatment 3.1 3.4 3.5 3.4 3.5Thesymptomsthatbotheryouthemost 3.4 3.2 3.5 3.4 3.4Allofthedifferentkindsofsymptoms* 3.4 3.1 3.6 3.5 3.3Whatsideeffectsyouexperience 3.2 3.3 3.5 3.1 3.4Typeofpain/discomfort 3.3 3.2 3.4 3.3 3.2Amountofpain/discomfort 3.3 3.2 3.4 3.3 3.2Whatyouworryaboutinatreatment 3.1 3.3 3.4 3.0 3.5Worklifeandabilitytomakealiving 3.4 3.2 3.2 3.1 3.0Howyourothermedicalconditions(besidesthisone)affectyou 3.2 3.0 3.2 3.3 3.1Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.0 3.1 3.2 3.3 3.0Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.1 3.1 3.2 3.0 3.1Howthecostaffectsyou 2.7 3.1 3.3 3.0 3.0Howtheinconvenienceordiscomfortaffectsyou 3.0 3.1 3.1 3.0 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 2.8 3.1 3.1 2.9Relationshipwithyourspouse/partner 3.0 2.9 3.1 2.8 2.8Relationshipwithandabilitytocareforyourchildren 2.9 2.9 2.9 2.8 2.8
Nrange= 34-53 52-104 116-251 25-60 27-53
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyFrequencyofCare
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01(unadjustedformultipletests)
22
Patientswhowererelieduponbyfamilymembersfordirectcareand/orfinancialsupportwerelesslikelythanotherstofeelwell-understoodbytheirmedicalcareproviders,whenitcametonearlyeveryaspectoftheirconditionsandlives.
PatientViewsonUnderstandingbyProviders:ByFamilyResponsibility
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell)
Yes (providescareorfinancial supporttofamilymembers)
No
What’smostimportanttoyouinatreatment 3.4 3.5Thesymptomsthatbotheryouthemost*** 3.2 3.6Allofthedifferentkindsofsymptoms*** 3.2 3.6Whatsideeffectsyouexperience 3.2 3.4Typeofpain/discomfort** 3.1 3.4Amountofpain/discomfort** 3.1 3.4Whatyouworryaboutinatreatment 3.2 3.3Worklifeandabilitytomakealiving 3.2 3.2Howyourothermedicalconditions(besidesthisone)affectyou** 3.0 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.1 3.2Howthecostaffectsyou 3.1 3.2Howtheinconvenienceordiscomfortaffectsyou 3.0 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 2.9 3.1Relationshipwithyourspouse/partner 3.0 3.0Relationshipwithandabilitytocareforyourchildren 2.8 2.9
Nrange= 144-217 110-297
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyFamilyResponsibility
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
23
Employedpatientswerelesslikelythanotherstofeelthatthefunctionalaspectsoftheirconditionswerewell-understoodbytheirproviders.Thosewhoworkedfull-timewereleastlikelytofeelthatthecost,theinconvenience,andotherworriesabouttreatmentswerewell-understood.Unemployedpatientswereleastlikelytofeelthattheirpain/discomfortandothersymptomswerewell-understood.
PatientViewsonUnderstandingbyProviders:ByEmploymentStatus
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Fulltime Parttime Retired No
What’smostimportanttoyouinatreatment 3.4 3.6 3.5 3.4Thesymptomsthatbotheryouthemost 3.4 3.4 3.5 3.3Allofthedifferentkindsofsymptoms 3.5 3.5 3.5 3.3Whatsideeffectsyouexperience 3.4 3.6 3.2 3.4Typeofpain/discomfort 3.3 3.5 3.4 3.2Amountofpain/discomfort 3.4 3.3 3.4 3.1Whatyouworryaboutinatreatment 3.1 3.3 3.3 3.4Worklifeandabilitytomakealiving 3.0 3.0 3.2 3.4Howyourothermedicalconditions(besidesthisone)affectyou 3.4 3.1 3.2 3.0Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.1 3.2 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.0 3.0 3.2 3.2Howthecostaffectsyou 3.0 3.2 3.2 3.2Howtheinconvenienceordiscomfortaffectsyou 3.0 3.1 3.2 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 2.9 3.0 3.2Relationshipwithyourspouse/partner 2.9 3.0 3.0 3.1Relationshipwithandabilitytocareforyourchildren 2.9 3.0 2.7 3.0
Nrange= 69-131 35-64 62-154 88-171
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyCurrentEmployment
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01(unadjustedformultipletests)
24
Patientswhohadparticipatedinclinicaltrialsweremorelikelythanotherstofeelwell-understoodbytheirmedicalcareproviderswhenitcametonearlyeveryaspectoftheirconditionsandlives,theonlyexceptionsbeingtheimpactsoftheirconditionsonfamilyrelationships.
PatientViewsonUnderstandingbyProviders:ByHistoryofTrialParticipation
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Yes No
What’smostimportanttoyouinatreatment 3.6 3.3Thesymptomsthatbotheryouthemost* 3.5 3.3Allofthedifferentkindsofsymptoms* 3.6 3.3Whatsideeffectsyouexperience* 3.5 3.2Typeofpain/discomfort 3.4 3.2Amountofpain/discomfort* 3.4 3.2Whatyouworryaboutinatreatment 3.4 3.2Worklifeandabilitytomakealiving 3.3 3.1Howyourothermedicalconditions(besidesthisone)affectyou 3.2 3.1Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.3 3.1Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.1Howthecostaffectsyou 3.2 3.1Howtheinconvenienceordiscomfortaffectsyou 3.2 3.0Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 3.0Relationshipwithyourspouse/partner 3.0 3.0Relationshipwithandabilitytocareforyourchildren 2.9 2.9
Nrange= 92-214 163-302
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyHaveEverParticipatedinaClinicalTrial
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01(unadjustedformultipletests)
25
Olderpatientsweremostlikelytofeelwell-understoodbytheirmedicalcareproviderswhenitcametonearlyeveryaspectoftheirconditions,theexceptionbeingthesideeffectsoftreatments(theNforthe76+agegroupwassmall,butthetrendoftenextendedtothe61-75agegroup).Patientsbetweenages31-45wereleastlikelytofeelunderstood.Thesetrendsmayrelatetothoseshowninpreviousslidesregardingtypesofconditionsexperienced,employmentstatus,familyresponsibilities,etc.
PatientViewsonUnderstandingbyProviders:ByAgeGroup
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) 76+ 61-75 46-60 31-45 18-30
What’smostimportanttoyouinatreatment 4.0 3.5 3.4 3.2 3.5Thesymptomsthatbotheryouthemost** 4.0 3.6 3.4 2.9 3.4Allofthedifferentkindsofsymptoms*** 3.9 3.6 3.4 2.9 3.6Whatsideeffectsyouexperience 3.5 3.4 3.4 3.1 3.8Typeofpain/discomfort* 3.8 3.5 3.2 2.9 3.5Amountofpain/discomfort** 3.8 3.5 3.2 2.9 3.2Whatyouworryaboutinatreatment* 4.1 3.4 3.3 3.0 3.3Worklifeandabilitytomakealiving 3.8 3.2 3.3 2.9 2.9Howyourothermedicalconditions(besidesthisone)affectyou 3.3 3.3 3.2 3.0 2.9Abilitytoperformbasictasksofliving(hygiene,housework,etc.)** 3.5 3.3 3.2 2.6 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity* 3.3 3.3 3.1 2.7 3.1Howthecostaffectsyou** 3.8 3.3 3.0 2.6 3.4Howtheinconvenienceordiscomfortaffectsyou 3.4 3.2 3.0 2.8 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.5 3.2 3.1 2.7 3.2Relationshipwithyourspouse/partner 3.5 3.1 3.0 2.6 3.2Relationshipwithandabilitytocareforyourchildren 4.0 2.9 2.9 2.5 3.7
Nrange= 5-18 78-185 96-183 44-71 6-14
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyAge
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
26
Whenitcametosymptoms,particularlypain,femalesonaveragefeltlessunderstoodbymedicalcareprovidersthandidmales.Thiswasalsotruefortreatmentpreferencesandforimpactsonbasictasksofdailylivingandrelationships,althoughthedifferencesintheseareasweresmaller.Malesfeltslightlylessunderstoodthanfemaleswhenitcametoimpactsonworklifeandsideeffects.
PatientViewsonUnderstandingbyProviders:BySex
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Female Male
What’smostimportanttoyouinatreatment 3.4 3.6Thesymptomsthatbotheryouthemost 3.4 3.6Allofthedifferentkindsofsymptoms* 3.3 3.6Whatsideeffectsyouexperience 3.4 3.3Typeofpain/discomfort 3.2 3.5Amountofpain/discomfort 3.2 3.5Whatyouworryaboutinatreatment 3.3 3.3Worklifeandabilitytomakealiving 3.2 3.1Howyourothermedicalconditions(besidesthisone)affectyou 3.1 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.1 3.1Howthecostaffectsyou 3.1 3.1Howtheinconvenienceordiscomfortaffectsyou 3.1 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 3.1Relationshipwithyourspouse/partner 2.9 3.0Relationshipwithandabilitytocareforyourchildren 2.8 2.9
Nrange= 167-340 59-121
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebySex
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
27
Ingeneral,patientswhoaresingleormarried/partneredfeelmostunderstoodbytheirmedicalcareproviders,whereasthosewhoaredivorced/separated,orparticularlywidowed,feelleastunderstood.Thedifferencesacrossgroupswereagainmorepronouncedforimpactsonrelationshipsthanforthemoreclinicalaspectsofthecondition.
PatientViewsonUnderstandingbyProviders:ByMaritalStatus
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell)
Married/domesticpartner
Divorced/separated Single Widow/
widower
What’smostimportanttoyouinatreatment 3.5 3.3 3.6 3.3Thesymptomsthatbotheryouthemost 3.5 3.3 3.5 3.0Allofthedifferentkindsofsymptoms 3.5 3.3 3.5 3.0Whatsideeffectsyouexperience 3.4 3.3 3.5 3.1Typeofpain/discomfort 3.4 3.1 3.5 3.1Amountofpain/discomfort 3.4 3.1 3.4 3.0Whatyouworryaboutinatreatment 3.3 3.2 3.4 3.3Worklifeandabilitytomakealiving 3.2 3.0 3.3 3.4Howyourothermedicalconditions(besidesthisone)affectyou* 3.3 2.9 3.3 2.7Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.2 3.1 3.3 2.8Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.1 3.2 2.8Howthecostaffectsyou 3.2 2.9 3.1 3.0Howtheinconvenienceordiscomfortaffectsyou 3.2 2.8 3.3 2.8Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 3.0 3.1 2.8Relationshipwithyourspouse/partner 3.1 2.8 3.0 2.3Relationshipwithandabilitytocareforyourchildren 2.8 2.9 3.1 2.1
Nrange= 129-249 49-101 36-86 8-31
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyMaritalStatus
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
28
Ingeneral,therewasatrendtowardaninverserelationshipbetweeneducationalattainmentandperceptionsofunderstanding.Thismayreflectpatternsofcarereceived(i.e.,ruralone-doctorvs.urbanmulti-doctor,migrationpatternsoverlifetime,etc.)and/orthetrustplacedinproviders.
PatientViewsonUnderstandingbyProviders:ByEducationalAttainment
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell)
Advanceddegree
Completedcollegedegree
Somecollege
Completedhighschool
What’smostimportanttoyouinatreatment 3.4 3.4 3.4 3.4Thesymptomsthatbotheryouthemost 3.3 3.5 3.4 3.5Allofthedifferentkindsofsymptoms 3.4 3.6 3.4 3.2Whatsideeffectsyouexperience 3.4 3.3 3.3 3.5Typeofpain/discomfort 3.3 3.4 3.2 3.4Amountofpain/discomfort 3.3 3.4 3.2 3.4Whatyouworryaboutinatreatment* 3.2 3.2 3.3 3.6Worklifeandabilitytomakealiving 3.1 3.3 3.1 3.3Howyourothermedicalconditions(besidesthisone)affectyou 3.1 3.3 3.1 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.2 3.1 3.1 3.3Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.0 3.0 3.2 3.3Howthecostaffectsyou 3.1 3.0 3.2 3.1Howtheinconvenienceordiscomfortaffectsyou 2.9 3.1 3.1 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 2.9 3.1 3.0 3.2Relationshipwithyourspouse/partner 3.0 2.8 3.1 3.1Relationshipwithandabilitytocareforyourchildren 2.7 2.7 3.1 2.8
Nrange= 52-110 81-154 70-149 23-52
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyHighestLevelofEducation(onlycategorieswithN>10)
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
29
Ingeneral,patientsresidingintheWesternUS/MountainareasfeltlessunderstoodthandidthoseintheMidwestorEasternregions,exceptregardingtheimpactsoftheirconditionsontheirabilitytowork.Regionaldifferenceswereparticularlypronouncedforimpactsonrelationships(bothfamilyandcommunity),asopposedtoclinicalaspectsofthediseasesuchassymptoms/painandabilitytoperformbasictasksofdailyliving,possiblyreflectingculturaldifferencesincommunication.
PatientViewsonUnderstandingbyProviders:ByGeographicRegion
Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell)
West,Southwest Mountain Midwest Northeast Southeast
What’smostimportanttoyouinatreatment 3.3 3.3 3.4 3.6 3.4Thesymptomsthatbotheryouthemost 3.2 3.5 3.5 3.4 3.5Allofthedifferentkindsofsymptoms 3.2 3.2 3.4 3.5 3.5Whatsideeffectsyouexperience 3.2 2.8 3.5 3.4 3.4Typeofpain/discomfort 3.1 3.2 3.2 3.4 3.4Amountofpain/discomfort 3.2 3.2 3.2 3.3 3.4Whatyouworryaboutinatreatment 3.1 3.1 3.4 3.3 3.3Worklifeandabilitytomakealiving 3.1 3.5 3.4 3.0 3.2Howyourothermedicalconditions(besidesthisone)affectyou 2.9 3.6 3.1 3.2 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.0 3.0 3.2 3.2 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.0 2.6 3.3 2.9 3.2Howthecostaffectsyou 3.1 2.6 3.0 3.1 3.2Howtheinconvenienceordiscomfortaffectsyou 2.8 2.6 3.0 3.2 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 2.8 3.2 3.0 3.1Relationshipwithyourspouse/partner 2.9 2.5 3.2 2.7 3.1Relationshipwithandabilitytocareforyourchildren 2.7 2.2 3.0 2.8 2.9
Nrange= 36-63 5-16 33-62 51-95 100-227
PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyRegion
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
30
Patients:ArethereaspectsofhowyourconditionortreatmentaffectsyouthatyoudoNOTsharewithyourhealthcareproviders?
UnderstandingofPatientsbyProviders
28%
72%
Yes
No
N=498
31
UnderstandingofPatientsbyProviders:ReasonsforNotSharing
• Embarrassment/shameintalkingaboute.g.disability,difficultywithpersonalorhomecare/hygiene,sexualorboweldysfunction,etc.
• Concernsregardingconfidentiality,notwantingittobecome“partofrecord”• Fearofe.g.gettingdriver’slicenserevoked,beingpreventedfromworking,beingusheredinto
“psychtrack”ofmedicalcare• Fearofbeingprescribedmedicationsthattheydon’twanttotake• Fearofhavingcurrentlyprescribedmedications“takenaway”• Emotionallydifficulttotalkaboutfears/anxieties,upsetting• Fearofjudgmentregardinge.g.dietaryhabits/weight,sexualhistory/lifestyle,substanceuse,etc.• Assumptionthatifhealthcareprovidersdon’taskaboutthesethings,thentheydon’tcare/not
partofjob;“medicineisaboutscience,notaboutlife”• Fearoftalkingaboutsomethingpersonalandmeaningfulandnotbeinglistenedto;feeling
unimportant,worthless• Perceptionofbeingrushedthroughmedicalvisits,notimetotalk• Previousexperiencewithtryingtotalktohealthcareprovidersaboutthesethingsandgetting
demeaning/uncaringresponsesà frustrationandhurt• Fearoflosingservicesiftheybecomelabeledas“difficult,”“refractory,”“time-consuming,”orat
riskforaddiction
32
UnderstandingofPatientsbyProviders: DiseaseAspectsNotShared
• Painandpsychologicalimpactsthereof• Disability,inwork,self-care,careofothers(e.g.children,pets)• Emotionalimpactsofdisease,i.e.anxiety,fears
– “Itriedtotellhimandhesaidhewasn’tasocialworker.”• “Non-critical,”“non-medical”aspectsofdisease,i.e.inabilityto“havefun,”toperformparticular
self-careorchild-caretasks,etc.– “Someissuesarenotmedical…Iamhavingtroublebuttoningmyshirt.And,Ican’tbend
overtotieshoesanymore.Ican’treachmyfeettoputonsocks.”• Impactsonsexualityandrelationships• Implicationsoflifestyledecisionsondisease,i.e.diet,sexuallifestyle,useofalternative
therapies,etc.• Anyinformationthatcouldimpactprivileges/permissions,i.e.visualeffectsthatcouldimpact
driver’slicense,injuries/painthatcouldimpactpermissiontoreturntowork,cognitiveissuesthatcouldimpactindependentliving,etc.
• Bowelfunction• Addiction/dependence• Obesity-relatedissues• Financialaspectsofdiseaseand/ortreatment
33
ConfidenceinInformationProvided
toClinicalTrialParticipants
34
Mostpatientshadatleastafairlevelofconfidencethattrialparticipantsareinformedfullyandhonestlyabouttheclinicaltrialprocess.Patientsweremostlikelytobeconfidentininformationprovidedaboutrighttowithdraw,procedures,andpossiblebenefits,andweremostskepticalaboutinformationrelatingtotreatmentalternatives,risksandsideeffects,anddoctors’motivations.
Patients’ConfidenceinClinicalTrialParticipantInformation
3%
4%
3%
4%
7%
7%
6%
13%
9%
12%
8%
14%
7%
7%
9%
10%
11%
12%
14%
14%
16%
15%
17%
17%
19%
20%
19%
23%
17%
19%
25%
19%
23%
21%
25%
27%
19%
28%
29%
26%
24%
21%
28%
21%
26%
21%
25%
17%
51%
41%
40%
38%
41%
40%
27%
33%
25%
31%
24%
26%
Righttodropoutofthestudy
Typesofprocedurestobeperformed
Possiblebenefitsofstudytreatment
Overalltimecommitment
Howpersonalinformationwillbekeptprivate
Costsassociatedwithstudyparticipation
Painordiscomforttoexpect
Ifandhowpatientswillreceiveinformationaboutthestudy
Possiblerisksofstudytreatment
Doctor’smotivationsfordoingthestudy
Possiblesideeffectsofstudytreatment
Otherwaysofgettingtreatmentbesidesstudyparticipation
1- Notatallconfident 2 3 4 5- Veryconfident
Mean N4.1 399
3.9 439
3.9 433
3.8 447
3.8 434
3.7 418
3.6 422
3.5 420
3.4 436
3.4 411
3.4 436
3.3 386
Whenpatientsareapproachedaboutclinicaltrialsrunbypharmaceuticalcompanies,howconfidentdoyoufeelthattheyareinformedfullyandhonestlyabouteachofthefollowing?
35
Typesofprocedures
Righttodropout
PossiblesideeffectsPossiblerisks
Possiblebenefits
Painordiscomfort
Privacyofpersonalinfo
Overalltimecommitment
Costs
Otherwaystogettreatment
Doctor'smotivations
Communicationofresults
3.0
3.5
4.0
4.5
5.0
3.0 3.5 4.0 4.5 5.0
Patie
nts
Sponsor/CROAQCMembers
BothpatientsandAQCMemberrespondentswerereasonablyconfidentinpatients’receiptofcompleteandhonestinformationabouttherighttowithdrawfromatrial,itsprocedures,anditspossiblebenefits,andbothwereskepticalaboutinformationregardingthecommunicationofresultsanddoctors’motivations.AQCMemberswerequiteconfidentinpatients’receiptofcompleteandhonestinformationaboutpossiblesideeffects,risks,anddiscomforts,butpatientswerelessso.
Patientvs.AQCMemberConfidenceinClinicalTrialInformation
Patients:N=386-447SponsorN=83-94,CRON=63-76Q:AsaSponsor/CROexecutingtrialsonbehalfofSponsors,howconfidentareyouthatpotentialclinicaltrialparticipantsarefullyandhonestlyinformedabouteachofthefollowing?
ConfidenceThatTrialParticipantsareInformedAbout…MeanRatings:1=NotAtAllConfidentto5=VeryConfident
36
Muchofthepatient-sponsordifferenceinconfidencewasdrivenbypatientswithnoexperienceinclinicaltrials;patientswithclinicaltrialexperiencehadsubstantiallygreaterlevelsofconfidence– muchclosertothelevelsexhibitedbyAQCmembers– thandidthosewithnohistoryofclinicaltrialparticipation(thisslideandnext).
Patients:N=185to204SponsorN=83-94,CRON=63-76Q:AsaSponsor/CROexecutingtrialsonbehalfofSponsors,howconfidentareyouthatpotentialclinicaltrialparticipantsarefullyandhonestlyinformedabouteachofthefollowing?
ConfidenceThatTrialParticipantsareInformedAbout…MeanRatings:1=NotAtAllConfidentto5=VeryConfident
Typesofprocedures
Righttodropout
Possiblesideeffects
Possiblerisks
Possiblebenefits
Painordiscomfort
Privacyofpersonalinfo
Overalltimecommitment
Costs
Otherwaystoget
treatment
Doctor'smotivations
Communicationofresults
3.0
3.5
4.0
4.5
5.0
3.0 3.5 4.0 4.5 5.0
Patie
ntsw
ithClinicalTria
lHistory
Sponsor/CROAQCMembers
PatientswithClinicalTrialHistoryvs.AQCMemberConfidenceinClinicalTrialInformation
37Patients:N=201to243SponsorN=83-94,CRON=63-76Q:AsaSponsor/CROexecutingtrialsonbehalfofSponsors,howconfidentareyouthatpotentialclinicaltrialparticipantsarefullyandhonestlyinformedabouteachofthefollowing?
Typesofprocedures
Righttodropout
PossiblesideeffectsPossiblerisks
Possiblebenefits
Painordiscomfort
Privacyofpersonalinfo
Overalltimecommitment
Costs
Otherwaystogettreatment
Doctor'smotivations
Communicationofresults
3.0
3.5
4.0
4.5
5.0
3.0 3.5 4.0 4.5 5.0
Patie
ntsw
ithou
tClinicalTria
lHistory
Sponsor/CROAQCMembers
ConfidenceThatTrialParticipantsareInformedAbout…MeanRatings:1=NotAtAllConfidentto5=VeryConfident
PatientswithoutClinicalTrialHistoryvs.AQCMemberConfidenceinClinicalTrialInformation
38
Meanratingsonascaleof1(notatallconfident)to5(veryconfident)
Chronicbutstable Degenerative Episodic
Righttodropoutofthestudy 4.1 4.0 3.9
Typesofprocedurestobeperformed 4.0 3.8 3.8
Possiblebenefitsofstudytreatment 3.9 3.9 3.8
Overalltimecommitment 3.9 3.8 3.7
Howpersonalinformationwillbekeptprivate 3.9 3.8 3.7
Costsassociatedwithstudyparticipation 3.8 3.7 3.5
Painordiscomforttoexpect* 3.7 3.4 3.6
Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults* 3.6 3.4 2.9
Possiblerisksofstudytreatment 3.5 3.4 3.1
Doctor’smotivationsfordoingthestudy 3.6 3.3 3.1
Possiblesideeffectsofstudytreatment* 3.5 3.3 3.1
Otherwaysofgettingtreatmentbesidesstudyparticipation* 3.4 3.0 3.2
Nrange= 228-260 112-130 36-44
Patientswithchronicconditionswereonaveragemoreconfidentthanothersintheinformationprovidedtoclinicaltrialparticipants,andthosewithepisodicconditionsweregenerallyleastconfident.
Patients’ConfidenceinClinicalTrialInformation:ByTypeofCondition
ConfidencethatStudyPatientsareFullyandHonestlyInformedbyTypeofMedicalCondition(onlycategorieswithN>10)
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
39
Patientswithmildconditionswereonaveragemoreconfidentthanothersintheinformationprovidedtoclinicaltrialparticipants.
Patients’ConfidenceinClinicalTrialInformation:ByImpactofCondition
Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Severe Moderate Mild Itvaries None
Righttodropoutofthestudy 4.1 4.0 4.3 4.3 3.8
Typesofprocedurestobeperformed 3.9 4.0 4.2 3.8 3.6
Possiblebenefitsofstudytreatment 4.0 3.8 4.2 3.9 4.0
Overalltimecommitment 3.9 3.7 4.1 3.7 3.9
Howpersonalinformationwillbekeptprivate* 3.8 3.6 4.3 3.8 3.7
Costsassociatedwithstudyparticipation* 3.7 3.6 4.2 3.6 3.6
Painordiscomforttoexpect 3.5 3.5 3.9 3.5 3.7
Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults 3.4 3.4 3.7 3.4 3.6
Possiblerisksofstudytreatment* 3.3 3.3 3.9 3.3 3.6
Doctor’smotivationsfordoingthestudy 3.4 3.3 3.7 3.3 3.8
Possiblesideeffectsofstudytreatment* 3.4 3.2 3.8 3.3 3.7
Otherwaysofgettingtreatmentbesidesstudyparticipation*** 3.0 3.1 3.9 3.5 3.5
Nrange= 113-135 142-156 64-75 42-56 22-29
ConfidencethatStudyPatientsareFullyandHonestlyInformedbyImpactofMedicalCondition
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
40
Therewasageneraltrendwherebypatientswhoseetheirphysiciansfrequentlymaybemoreskepticalabouttheinformationprovidedtoclinicaltrialparticipantsthanwerepatientswhoseetheirphysicianslessoften.
Patients’ConfidenceinClinicalTrialInformation:ByFrequencyofCare
Meanratingsonascaleof1(notatallconfident)to5(veryconfident)
Morethan12timesperyear
5to12timesperyear
2to4times
peryear
Onceperyearorless
Itdepends
Righttodropoutofthestudy 3.8 4.0 4.1 3.9 4.2
Typesofprocedurestobeperformed* 3.8 3.6 4.1 4.0 4.0
Possiblebenefitsofstudytreatment 4.0 3.8 4.0 4.0 4.0
Overalltimecommitment 3.8 3.8 3.8 4.1 3.8
Howpersonalinformationwillbekeptprivate 3.5 3.7 3.9 3.7 4.1
Costsassociatedwithstudyparticipation 3.8 3.6 3.9 3.5 3.7
Painordiscomforttoexpect* 3.6 3.2 3.6 3.9 3.7
Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults 3.2 3.3 3.6 3.4 3.7
Possiblerisksofstudytreatment 3.4 3.1 3.5 3.5 3.7
Doctor’smotivationsfordoingthestudy 3.4 3.4 3.5 3.4 3.6
Possiblesideeffectsofstudytreatment 3.4 3.1 3.5 3.5 3.5
Otherwaysofgettingtreatmentbesidesstudyparticipation 3.1 3.0 3.3 3.5 3.4Nrange= 37-43 70-83 191-224 43-49 37-48
ConfidencethatStudyPatientsareFullyandHonestlyInformedbyFrequencyofCare
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
41
Patientswhohadactuallyparticipatedinclinicaltrialsweremoreconfidentinthehonestyandcompletenessofinformationprovidedtotrialparticipantsthanwerepatientswhohadnot,ineveryareaexceptforone:howpatientswouldreceivestudyresults,includingpersonalresults.Evenamongpriortrialparticipants,however,confidencewasnotstronginsomeareas.
Patients’ConfidenceinClinicalTrialInformation:ByHistoryofTrialParticipation
Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Yes No
Righttodropoutofthestudy*** 4.3 3.9
Typesofprocedurestobeperformed**** 4.2 3.8
Possiblebenefitsofstudytreatment 4.0 3.9
Overalltimecommitment** 4.0 3.7
Howpersonalinformationwillbekeptprivate 3.9 3.7
Costsassociatedwithstudyparticipation* 3.9 3.6
Painordiscomforttoexpect 3.7 3.5
Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults 3.5 3.5
Possiblerisksofstudytreatment** 3.6 3.3
Doctor’smotivationsfordoingthestudy* 3.6 3.3
Possiblesideeffectsofstudytreatment* 3.5 3.3
Otherwaysofgettingtreatmentbesidesstudyparticipation 3.4 3.1
Nrange= 185-204 201-243
ConfidencethatStudyPatientsareFullyandHonestlyInformedbyHistoryofTrialParticipation
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005;****p=.0001(unadjustedformultipletests)
42
Ingeneral,patientsbetween31and60yearsofagewerelessconfidentinthehonestyandcompletenessofinformationprovidedtotrialparticipantsthanwereyoungerorolderpatients.
Patients’ConfidenceinClinicalTrialInformation:ByAgeGroup
Meanratingsonascaleof1(notatallconfident)to5(veryconfident) 76+ 61-75 46-60 31-45 18-30
Righttodropoutofthestudy 4.2 4.2 4.0 3.9 4.1
Typesofprocedurestobeperformed 4.2 4.1 3.8 3.7 3.7
Possiblebenefitsofstudytreatment 3.9 4.0 3.9 3.8 4.2
Overalltimecommitment 4.1 4.0 3.7 3.7 4.0
Howpersonalinformationwillbekeptprivate 4.0 3.9 3.8 3.6 4.0
Costsassociatedwithstudyparticipation* 4.3 4.0 3.5 3.5 3.9
Painordiscomforttoexpect* 3.8 3.8 3.5 3.2 4.1
Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults. 3.8 3.6 3.4 3.1 4.1
Possiblerisksofstudytreatment* 3.8 3.6 3.3 3.1 4.0
Doctor’smotivationsfordoingthestudy 4.1 3.5 3.4 3.3 3.8
Possiblesideeffectsofstudytreatment* 3.7 3.6 3.3 3.2 3.6
Otherwaysofgettingtreatmentbesidesstudyparticipation 3.7 3.4 3.3 2.8 2.9
Nrange= 13-19 156-180 150-171 52-65 9-10
ConfidencethatStudyPatientsareFullyandHonestlyInformedbyAge
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
43
Particularlyfortheaspectsofclinicaltrialinformationaboutwhichpatientsoverallwerelessconfident(towardthebottomofthetable),therewasgenerallyaninverserelationshipbetweeneducationalattainmentandconfidenceintheinformationprovided.
Patients’ConfidenceinClinicalTrialInformation:ByEducationalAttainment
Meanratingsonascaleof1(notatallconfident)to5(veryconfident)
Advanceddegree
Completedcollegedegree
Somecollege
Completedhighschool
Righttodropoutofthestudy 4.2 3.9 4.0 4.4
Typesofprocedurestobeperformed 4.1 3.9 3.9 4.0
Possiblebenefitsofstudytreatment 3.9 3.9 4.0 4.1
Overalltimecommitment 3.8 3.8 3.8 4.2
Howpersonalinformationwillbekeptprivate 4.0 3.8 3.7 4.1
Costsassociatedwithstudyparticipation 3.8 3.7 3.7 4.0
Painordiscomforttoexpect 3.6 3.5 3.6 3.7
Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults* 3.4 3.4 3.4 4.2
Possiblerisksofstudytreatment 3.4 3.3 3.5 3.5
Doctor’smotivationsfordoingthestudy* 3.2 3.3 3.5 4.0
Possiblesideeffectsofstudytreatment 3.3 3.4 3.4 3.6
Otherwaysofgettingtreatmentbesidesstudyparticipation 3.2 3.1 3.3 3.6Nrange= 93-105 126-147 115-139 42-48
ConfidencethatStudyPatientsareFullyandHonestlyInformedbyHighestLevelofEducation(onlycategorieswithN>10)
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
44
ConfidenceinQualityofClinicalResearchProcess
45
3%
3%
4%
4%
8%
6%
9%
9%
12%
12%
18%
8%
9%
10%
9%
10%
13%
13%
14%
15%
17%
20%
19%
21%
20%
22%
21%
27%
21%
23%
26%
25%
23%
26%
27%
27%
25%
24%
23%
28%
28%
22%
20%
18%
43%
40%
39%
39%
37%
30%
29%
27%
25%
26%
22%
Studyteamscollectpatientstudydatainanhonestandunbiasedway.
Studyteamsperformthestudiesexactlythewaytheyaresupposedto.
Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”
Studyteamscarefullymonitorthewell-beingofstudypatients.
Studyteamscareaboutstudypatientsaspeople.
Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto.
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway.
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients.
Pharmaceuticalcompaniescareaboutstudypatientsaspeople.
1- Notatallconfident 2 3 4 5- Veryconfident
Mean N
4.0 442
3.9 434
3.9 440
3.8 442
3.7 430
3.6 430
3.5 454
3.5 456
3.3 415
3.3 416
3.1 414
Mostpatientshadatleastafairlevelofconfidenceinthecompliance,caring,andethicsofthesitestudyteamsandpatientsinvolvedinclinicaltrials.However,manywereskepticalaboutthehonestyofpharmaceuticalcompaniesandabouttheextenttowhichtheycaredaboutstudypatients.
Patients’ConfidenceinClinicalTrialComplianceandEthics
Whenitcomestoclinicaltrialsrunbypharmaceuticalcompanies,whatisyourlevelofconfidenceineachofthefollowing?
46
3.0
3.5
4.0
4.5
5.0
3.0 3.5 4.0 4.5 5.0
Patie
nts
Sponsor/CROAQCMembers
Studiesaredesignedtoanswerquestionsaboutbenefits/risksinhonest/unbiasedway.
Pharmacompaniescarefullymonitorthewellbeingofstudypatients.
Pharmacompaniesreportonstudydatainanhonest/unbiasedway.
Pharmacompaniescareaboutstudypatientsaspeople.
SponsorN=95-99,CRON=75-83;PatientsN=414-456
Patientstakingpartinclinicalstudiesfollowinstructionscarefully.
Onaverage,bothpatientsandAQCMemberrespondentswereslightlyskepticalaboutthecomplianceofpatientstakingpartinclinicalstudies.However,patientsweremuchmoreskepticalaboutthehonestyandcaringofpharmaceuticalcompaniesthanwereAQCMembers.
Patientvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics
Levelofconfidencethat…MeanRatings:1=NotAtAllConfidentto5=VeryConfident
47
3.0
3.5
4.0
4.5
5.0
3.0 3.5 4.0 4.5 5.0
Patie
ntsw
ithClinicalTria
lHistory
Sponsor/CROAQCMembers
Studiesaredesignedtoanswerquestionsaboutbenefits/risksinhonest/unbiasedway.
Pharmacompaniescarefullymonitorthewellbeingofstudypatients.
Pharmacompaniesreportonstudydatainanhonest/unbiasedway.
Pharmacompaniescareaboutstudypatientsaspeople.
SponsorN=95-99,CRON=75-83;PatientsN=178-201
Patientstakingpartinclinicalstudiesfollowinstructionscarefully.
Again,muchofthepatient-sponsordifferenceinconfidencewasdrivenbypatientswithnoexperienceinclinicaltrials;patientswithclinicaltrialexperiencehadsubstantiallygreaterlevelsofconfidence– muchclosertothelevelsexhibitedbyAQCmembers– thandidthosewithnohistoryofclinicaltrialparticipation(thisslideandnext).
Patientvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics
Levelofconfidencethat…MeanRatings:1=NotAtAllConfidentto5=VeryConfident
48
3.0
3.5
4.0
4.5
5.0
3.0 3.5 4.0 4.5 5.0
Patie
ntsw
ithou
tClinicalTria
lHistory
Sponsor/CROAQCMembers
Studiesaredesignedtoanswerquestionsaboutbenefits/risksinhonest/unbiasedway.
Pharmacompaniescarefullymonitorthewellbeingofstudypatients.
Pharmacompaniesreportonstudydatainanhonest/unbiasedway.
Pharmacompaniescareaboutstudypatientsaspeople.
SponsorN=95-99,CRON=75-83;PatientsN=230-258
Patientstakingpartinclinicalstudiesfollowinstructionscarefully.
Levelofconfidencethat…MeanRatings:1=NotAtAllConfidentto5=VeryConfident
PatientswithNoClinicalTrialHistoryvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics
49
Whenaskedhowwellpatient-centricthinkingisincorporatedintothedesignandexecutionofclinicaltrials,bothSponsorsandCROsratethemselvessimilarly,moreorlessintheneutralrange.However,bothgroupsratetheirpartnerslowerandtowardsamoreneutralpositionthantheyseethemselves.
AQCMembers:PerceptionsofPatient-CentricThinking
PerceptionsofPatientCentricityinTrialDesign&ExecutionMeanRatings:1=NotWellAtAllto5=VeryWell
5%
5%
2%
2%
22%
12%
17%
7%
32%
28%
40%
27%
30%
31%
34%
40%
11%
23%
7%
23%
Sponsorsyouworkwith
Yourcompany
YourClinicalServiceProviders
Yourcompany
Mean
3.2
3.6
3.3
3.7
SponsorN=88-95,CRON=76-81Q:PleaserateyourcompanyandyourClinicalServiceProviders/Sponsorsyouhaveworkedwithinthepastyearonhowwellpatient-centricthinkingisincorporatedintothedesignandexecutionofclinicaltrials.
Sponsor
CRO
50
Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Chronic Degenerative Episodic
Studyteamscollectpatientstudydatainanhonestandunbiasedway. 4.0 3.9 3.9Studyteamsperformthestudiesexactlythewaytheyaresupposedto. 4.0 3.8 3.8Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.” 3.9 3.8 3.8
Studyteamscarefullymonitorthewell-beingofstudypatients. 3.9 3.7 3.9Studyteamscareaboutstudypatientsaspeople. 3.8 3.6 3.6Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.6 3.5 3.6
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 3.6 3.4 3.5
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.** 3.6 3.3 3.3
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway. 3.4 3.1 3.4
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.4 3.1 3.6
Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 3.2 2.8 3.0Nrange= 232-263 123-141 38-41
Patientswithchronicconditionswereonaveragemoreconfidentthanothersinthecompliance,ethics,andcaringofthoseexecutingclinicaltrials,andthosewithdegenerativeconditionsweregenerallyleastconfident.
Patients’ConfidenceinTrialCompliance/Ethics:ByTypeofCondition
ConfidenceinClinicalTrialComplianceandEthicsbyTypeofMedicalCondition(onlycategorieswithN>10)
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
51
Onaverage,patientswithmilddiseaseweremoreconfidentthanothersinthecompliance,ethics,andcaringofthoseexecutingclinicaltrials,andthosewithmoderateorvariableseverityweregenerallyleastconfident.
Patients’ConfidenceinTrialCompliance/Ethics:ByImpactofCondition
Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Severe Moderate Mild Itvaries None
Studyteamscollectpatientstudydatainanhonestandunbiasedway. 4.0 3.9 4.2 3.9 4.0
Studyteamsperformthestudiesexactlythewaytheyaresupposedto. 4.0 3.8 4.2 3.9 4.0
Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.” 3.9 3.8 4.1 3.8 3.9
Studyteamscarefullymonitorthewell-beingofstudypatients. 3.8 3.7 4.1 3.8 4.0Studyteamscareaboutstudypatientsaspeople. 3.7 3.6 4.1 3.6 3.9Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.6 3.5 3.6 3.6 3.8
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 3.5 3.4 3.9 3.4 3.6
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway. 3.5 3.4 3.8 3.3 3.8
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway. 3.3 3.2 3.8 3.2 3.4
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients.* 3.2 3.2 3.8 3.2 3.5
Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 3.0 2.9 3.5 3.0 3.2Nrange= 124-139 144-159 60-72 53-59 25-29
ConfidenceinClinicalTrialComplianceandEthicsbyImpactofMedicalCondition
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
52
Onaverage,patientswhosawtheirtreatingphysiciansfrequentlyweremoreskepticalaboutthecompliance,ethics,andcaringofthoseexecutingclinicaltrialsthanwerethosewhosawtheirproviderslessfrequently.
Patients’ConfidenceinTrialCompliance/Ethics:ByFrequencyofCare
Meanratingsonascaleof1(notatallconfident)to5(veryconfident)
Morethan12timesperyear
5to12times
peryear
2to4times
peryear
Onceperyearorless
Itdepends
Studyteamscollectpatientstudydatainanhonestandunbiasedway. 3.9 3.8 4.0 4.1 4.0
Studyteamsperformthestudiesexactlythewaytheyaresupposedto. 3.9 3.7 4.0 4.1 4.0
Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.” 3.6 3.7 4.0 3.9 3.9
Studyteamscarefullymonitorthewell-beingofstudypatients. 3.8 3.6 3.9 3.9 4.1Studyteamscareaboutstudypatientsaspeople. 3.5 3.4 3.8 3.9 3.9Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.4 3.6 3.6 3.6 3.5
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 3.3 3.3 3.6 3.6 3.7
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway. 3.5 3.4 3.5 3.6 3.5
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway. 3.2 3.0 3.4 3.5 3.3
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.1 3.2 3.4 3.5 3.3
Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 2.9 2.9 3.1 3.2 3.1Nrange= 38-43 78-88 202-224 43-51 42-49
ConfidenceinClinicalTrialComplianceandEthicsbyFrequencyofCare
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)
53
Onaverage,patientswhohadparticipatedinclinicaltrialsweremoreconfidentinthecompliance,ethics,andcaringofthoseexecutingclinicaltrialsthanwerethosewhohadnot.
Patients’ConfidenceinTrialCompliance/Ethics:ByHistoryofTrialParticipation
Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Yes No
Studyteamscollectpatientstudydatainanhonestandunbiasedway.*** 4.2 3.8
Studyteamsperformthestudiesexactlythewaytheyaresupposedto.* 4.1 3.8
Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”**** 4.1 3.7
Studyteamscarefullymonitorthewell-beingofstudypatients.*** 4.1 3.7
Studyteamscareaboutstudypatientsaspeople.*** 4.0 3.5
Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.6 3.5
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway.*** 3.8 3.4
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.** 3.7 3.4
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.** 3.5 3.2
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.5 3.2
Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 3.2 3.0
Nrange= 178-201 230-258
ConfidenceinClinicalTrialComplianceandEthicsbyHistoryofTrialParticipation
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005;****p<.0001(unadjustedformultipletests)
54
Ingeneral,therewasaninverserelationshipbetweenlevelofeducationalattainmentandconfidenceinthecompliance,ethics,andcaringofthoseexecutingclinicaltrials.
Patients’ConfidenceinTrialCompliance/Ethics:ByEducationalAttainment
Meanratingsonascaleof1(notatallconfident)to5(veryconfident)
Advanceddegree
Completedcollegedegree
Somecollege
Completedhighschool
Studyteamscollectpatientstudydatainanhonestandunbiasedway.* 3.8 4.0 4.0 4.3Studyteamsperformthestudiesexactlythewaytheyaresupposedto.** 3.7 3.9 3.9 4.3Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”* 3.7 3.8 3.9 4.3
Studyteamscarefullymonitorthewell-beingofstudypatients. 3.7 3.9 3.9 4.1Studyteamscareaboutstudypatientsaspeople. 3.4 3.8 3.8 4.0Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto.* 3.3 3.5 3.7 3.7
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 3.3 3.6 3.6 3.8
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway. 3.3 3.6 3.4 3.8
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.** 2.9 3.4 3.4 3.7
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients.* 3.0 3.4 3.3 3.7
Pharmaceuticalcompaniescareaboutstudypatientsaspeople.** 2.7 3.1 3.1 3.5Nrange= 100-109 129-144 131-149 40-48
ConfidenceinClinicalTrialComplianceandEthicsbyHighestLevelofEducation(categorieswithN>10only)
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005;****p<.0001(unadjustedformultipletests)
55
Ingeneral,patientsbetween31and60yearsofagewerelessconfidentinthecompliance,ethics,andcaringofthoseinvolvedinclinicaltrialexecutionthanwereyoungerorolderpatients.Thoseinthe76+agegrouphadthehighestlevelofconfidence.
Patients’ConfidenceinTrialCompliance/Ethics:ByAgeGroup
Meanratingsonascaleof1(notatallconfident)to5(veryconfident) 76+ 61-75 46-60 31-45 18-30
Studyteamscollectpatientstudydatainanhonestandunbiasedway.* 4.5 4.1 3.9 3.7 3.9
Studyteamsperformthestudiesexactlythewaytheyaresupposedto.** 4.6 4.1 3.8 3.7 4.0
Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.” 4.3 4.0 3.8 3.6 4.0
Studyteamscarefullymonitorthewell-beingofstudypatients. 4.3 3.9 3.8 3.7 3.9Studyteamscareaboutstudypatientsaspeople. 4.4 3.8 3.7 3.5 3.5Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 4.1 3.6 3.5 3.5 3.6
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 4.1 3.7 3.4 3.4 3.6
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.* 4.2 3.6 3.4 3.3 3.6
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway. 3.9 3.4 3.2 3.3 3.3
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.8 3.4 3.3 3.2 3.2
Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 3.6 3.1 3.1 3.0 2.6Nrange= 14-20 162-182 160-177 59-65 9-12
ConfidenceinClinicalTrialComplianceandEthicsbyAge
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005;****p<.0001(unadjustedformultipletests)
56
Onaverage,patientswhowereresponsibleforprovidingdirectcareorfinancialsupportoffamilymembersweremoreskepticalaboutthecompliance,ethics,andcaringofthoseexecutingclinicaltrialsthanwerethosewhowerenot.
Patients’ConfidenceinTrialCompliance/Ethics:ByFamilyResponsibility
Meanratingsonascaleof1(notatallconfident)to5(veryconfident)
Yes (providescareorfinancial supporttofamilymembers)
No
Studyteamscollectpatientstudydatainanhonestandunbiasedway.* 3.8 4.1
Studyteamsperformthestudiesexactlythewaytheyaresupposedto.* 3.8 4.0
Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”* 3.7 4.0
Studyteamscarefullymonitorthewell-beingofstudypatients. 3.7 3.9
Studyteamscareaboutstudypatientsaspeople. 3.7 3.7
Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.4 3.7
Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway.* 3.4 3.6
Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.* 3.3 3.6
Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.* 3.2 3.4
Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.2 3.4
Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 2.9 3.1Nrange= 165-186 246-270
ConfidenceinClinicalTrialComplianceandEthicsbyFamilyResponsibility
Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005;****p<.0001(unadjustedformultipletests)
57
ThemesinOpen-EndedCommentsPatientViewsonActionsthatInfluenceConfidence
• Interactionwithpatientsforfeedbackaboutstudydesignandoperations
– “Theydon’tinteractwithparticipantstogetfeedbackonwhatwasgoodorbadaboutthestudy.”
– “Evidenceofincludingpatientparticipationintrials’creation,monitoring,andmeasurementofassessmentusingviabletools.”
• Faircompensation,andcaring,respectful,andequitabletreatmentasparticipantsintheresearchprocess:
– “Whiletheprotocolispatient-centered,theback-upandbedsidemannerdonotalwayswork.”
– “Careaboutpatientsaspeople?Ha!Thenwhyarewecalled‘subjects’??Andwhyaren’twecompensatedmuchbetterandsoonerinthestudy?Thesponsorsmakeobsceneamountsofmoneyandskipwhenitcomestoallaspectsofpatientinteraction.Whyarethevisitsalwayssoinconvenient?Whyaren’tthereeveningandweekendhours?Whyaren’tstafftrainedininterpersonalcommunication,especiallythechiefinvestigatingphysician?”
– “Itboilsdowntotheirtakingtimewithme.Beingtransparentaboutwhattheyaredoingstep-by-stepandexplainingwhatisgoingon.”
58
ThemesinOpen-EndedComments,continuedPatientViewsonActionsthatInfluenceConfidence
• Averylargenumberofcommentshadtodowithbusinessconcerns.Whilepatientsweremostlikelytocitetheprofitmotivesofpharmaceuticalcompaniesormedicalpractitionersasahugesourceofdistrust,somealsoderivedconfidencefromthisfact,reflectingthat“findingthetruth”madegoodbusinesssenseandthatanyunethicalconductwouldreturnpoorlyinthelongtermbothintermsofproductinvestmentsandintermsofliabilities.
– “Themedicalandpharmaceuticalindustries’mainpriorityismoney!Whenmoneyisthemostimportantthing,peoplearenottoldcompleteinformation.It’sabasicconflictofinterest!”
– “Re.doctors’motivations,Idon’trememberthisparticularaspectofeithertrialweparticipatedin,orthevariousothertrialsIconsidered,everhavingbeenmentioned.”
– “Ithinkmostofthemunderstandthatforlong-termsuccesstheyneedtodevelopdrugsthataregoodforbothpatientsandtheircompany,soincentivesarealignedinsomerespect.”
– “I’vebeentoconferenceswherethemainspeakeristryingtoconvincepeopletoparticipateinclinicaltrials.Noneofthesideeffectswereaddressed.Itwastrulya‘salespitch.’”
59
ThemesinOpen-EndedComments,continuedPatientViewsonActionsthatInfluenceConfidence
• Manypatientsreportthattheirconfidenceintheteamsperformingclinicalstudiescomeslargelyfromtheirfaiththatthesepartiesaregovernedbyregulationsandmonitoringbodies(includingethicscommittees),andfearfuloflawsuits.
• Manyalsoreportconfidencesimplyintheprofessionalismandgoodintentionsofresearchers,practitioners,andinstitutionsoperatinginthemedicalfield.
• Perceivedtransparencyintheareasofstudyprocedures,studyresults,drugrisks,IRBinteractions,doctormotivations,etc.wasregardedasasourceofconfidencebypatientswhohadexperiencedsuchtransparency.Conversely,alackoftransparencyintheserespects,particularlyinthedisseminationofresults,wascitedasasourceofdistrust.
– “Theteam…madesureIunderstoodeverythingaboutthestudyandwasquicktorespondwhenanyquestioncameup.”
– “IaskedforfeedbackafterthestudyIdidparticipateinandneverreceivedit.Iknowofno-onewhotrustspharmaceuticalcompanies.”“IfeelasthoughIhavebeenforgotten.”
• Mediareportsregardingcorruptionanddrugrecalls,andlawyer’sadvertisementsregardingclassactionsuits,werecitedassourcesofdistrustintheindustry.
60
PerspectivesonClinicalTrialParticipation
61
Nearlyhalfofthepatientsurveyedhadparticipatedinaclinicaltrial.Themostcommonreasonfordoingsowastheopportunitytocontributetoscience,followedbytheopportunitytolearnmoreabouttheirconditionsandbypaymentforparticipation.Themajorityofclinicaltrialparticipantsreportedfeelingmoreeducatedandinvolvedintheiroverallhealthasaresult.
PatientSurvey:ClinicalTrialParticipationRateandReasons
Whydidyoudecidetoparticipateintheclinicaltrial?
69%
51%
39%
21%
15%
15%
10%
2%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebeabletouse
Other
Influencedbymyfamily/friends65%14%
21% Yes
Notsure
No
N=302
45%55%
Yes
No
Haveyoueverparticipatedinaclinicaltrial?
N=582
Ifyes,didyoufeelmoreeducatedandinvolvedinyouroverallhealthasaresult?
N=260
62
52%
48%
36%
16%
0%
4%
12%
0%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
71%
60%
36%
17%
17%
13%
9%
1%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
Whydidyoudecidetoparticipateintheclinicaltrial?byTypeofMedicalCondition
71%
47%
41%
24%
18%
16%
11%
3%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N156
70
25
Thereweresomedifferencesacrosspatientswithdifferenttypesofmedicalconditionsinthereasonsfordecidingtoparticipateinclinicaltrials.Althoughthetopfourreasonswereallthesame,andinthesameorder,patientswithchronicanddegenerativeconditionsgenerallyendorsedmorereasonsfortrialparticipationthandidthosewithepisodicconditions,particularlyincludingadesireformorecontactwithdoctors/nurses,andaccesstobetterhospitalsanddoctors,thantheywouldotherwiseget.
PatientSubsets:TypeofMedicalCondition
Chronic
Degenerative
Episodic
63
63%
48%
33%
28%
11%
17%
9%
0%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
72%
55%
39%
18%
17%
11%
6%
3%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
PatientSubsets:ImpactofMedicalCondition
Whydidyoudecidetoparticipateintheclinicaltrial?byImpactofMedicalCondition
70%
55%
36%
18%
15%
20%
15%
3%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N66
94
54
28
14
Severe
Moderate
Mild
Itvaries
None
Therewerealsodifferencesacrosspatientswithdifferentseveritiesofmedicalconditions.Althoughagainthetopthreereasonsfortrialparticipationwereallthesame,patientswithmilddiseaseweremorelikelytobeinfluencedbyaccesstofreehealthcarethanwerethosewithmoreseriousconditions,andthosewithnoimpactweremorelikelytobeinfluencedbypayment(seenextslide).
64
71%
36%
50%
14%
14%
7%
14%
0%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
PatientSubsets:ImpactofMedicalCondition(continued)
Whydidyoudecidetoparticipateintheclinicaltrial?byImpactofMedicalCondition
71%
50%
43%
29%
18%
14%
11%
4%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N66
94
54
28
14
Severe
Moderate
Mild
Itvaries
None
65
65%
53%
48%
25%
15%
23%
5%
0%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
PatientSubsets:EmploymentStatus
Whydidyoudecidetoparticipateintheclinicaltrial?byCurrentEmployment
74%
42%
32%
21%
15%
13%
10%
3%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N62
40
88
70
Fulltime
Parttime
Retired
No
Notsurprisingly,employmentstatusalsoinfluencedpatients’decision-makingcriteria(thisslideandnext).Againthetopthreereasonsfortrialparticipationwereallthesame,however,fullyemployedpatientswerelesslikelythanotherstobeinfluencedbypaymentorbytheopportunitytolearnabouttheirconditions,andmorelikelytobeinfluencedbythechancetocontributetoscience.
66
71%
59%
34%
20%
11%
21%
11%
1%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
PatientSubsets:EmploymentStatus(continued)
Whydidyoudecidetoparticipateintheclinicaltrial?byCurrentEmployment
66%
50%
43%
19%
19%
7%
11%
3%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N62
40
88
70
Fulltime
Parttime
Retired
No
67
67%
51%
36%
19%
13%
7%
14%
2%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
PatientSubsets:AgeGroup
Whydidyoudecidetoparticipateintheclinicaltrial?byAge(onlycategorieswithN>10)
71%
57%
29%
21%
36%
14%
14%
0%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N
14
95
82
18
76+
61-75
46-60
31-45
Agegroupappearedtohaveasubstantialimpactonpatients’decision-makingcriteria(thisslideandnext),thoughtheNsinsomegroupsweresmall.Forolderpatients(76+),theadditionalexpectedcontactwithdoctorsandnurseswasakeyreasonforparticipation,whereasforyoungerpatients(31-60),accesstobetterdoctorsandhospitalswasmorelikelytobeakeyfactor.
68
72%
50%
33%
22%
17%
22%
6%
6%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
PatientSubsets:AgeGroup(continued)
Whydidyoudecidetoparticipateintheclinicaltrial?byAge
68%
55%
44%
24%
12%
17%
9%
1%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N
14
95
82
18
76+
61-75
46-60
31-45
69
64%
50%
31%
21%
17%
14%
10%
5%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwould…
AccesstobetterdoctorsandhospitalsthanIwould…
Other
Influencedbymyfamily/friends
PatientSubsets:Sex
Whydidyoudecidetoparticipateintheclinicaltrial?bySex
71%
54%
41%
22%
13%
13%
11%
1%
Opportunitytocontributetoscience
Opportunitytolearnmoreaboutmycondition
Iwaspaidtoparticipate
Accesstofreehealthcare
Morecontactwithdoctors/nursesthanIwouldotherwiseget
AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe
abletouse
Other
Influencedbymyfamily/friends
N
150
58
Female
Male
Femalesingeneralendorsedmorereasonsforparticipatinginclinicaltrialsthandidmales,thoughtheoverallpatternoftopreasonswasthesame.
70
ThemajorityofbothAQCMembersandPatientsstatedthattheywouldrecommendclinicalresearchparticipationtoalovedoneorfriend,butmanyineachgroupstatedthattheyweren’tsure.Amongthosenotsure,severityofdiseaseandavailabilityofotheroptionswerevolunteeredascommentsforambivalence.
WillingnesstoRecommendClinicalResearchParticipation
82%
2%16% Yes
No
Notsure 67%4%
29% Yes
No
Notsure
SponsorN=102,CRON=85;PatientsN=422Q:Basedonyourexperience,wouldyourecommendclinicalresearchparticipationtoalovedoneorfriend?
Sponsor/CROAQCMembers Patients
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Amongthosewhoresponded“Yes”,responsescarriedthemesofconsiderationofrisksandbenefits,oftheinstitutionsatwhichthestudiesarebeingperformed,andofawishto“dogood”forsociety.“No”responsesgenerallyreflecteddistrustoftheindustry.
Patients:ClinicalTrialParticipation
• “Itwoulddependonthedrugsinvolved,lengthoftime,andseverityofmyfriend’scondition.”• “Ifit’sadouble-blindtrialwithplacebo,thenI’mhesitanttoparticipateorrecommendparticipationbecauseImightwindupgoingwithoutmedicationforaconditionthatneedsmedicating.”• “Ionlydoitforthemoney.”• “Ifmorepeopledon’tparticipateinclinicalresearch,thentheymightaswellconsiderthemselvesasbeingexperimentedonwithmarketeddrugs.”• “Don’tgoinblindanddumb.Askplentyofquestions.Itwouldhelpifpatientsgotacrashcourseinwhatthestudywasaboutandwhattoexpectintheformofapamphlet.Neverseenthatbefore.Everythingisvague,politicallycorrect,andgeneral…Wealsoneedtobecompensatedbetter,likewematterasmuchastherestofthestudyteam.”• “Scienceneedsallthehelpitcanget.”• “Iwanttohelppeople.EvenifIendupintheplacebogroup.”
PatientsN=422Q:Basedonyourexperience,wouldyourecommendclinicalresearchparticipationtoalovedoneorfriend?
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Amongthosewhoresponded“Yes”,responsescarriedacommonthemeofdirecircumstance(lifethreateningdisease/absenceofotheroptions)andconsiderationofrisksandbenefits.“No”responsesdidnotoffercomments.
AQCMembers:ClinicalTrialParticipation
• “IwouldparticipateinaclinicaltrialmyselfifitwasfortreatmentforaconditionIwassufferingfromandIbelievedthatthistrialcouldbenefitmeandsociety.”• “Ofcourse,Iwouldsaythatnotalltrialsarecreatedequalandthelovedoneorfriendshouldevaluatetheconsentdocumentcarefully,asklotsofquestions,andaskforadditionalsourcesofinformation.”• “Iftherearelimitedtreatmentswhichareapprovedandavailabletoafamilymember,Iwoulddefinitelyrecommendaclinicaltrialapproach.”• “PhaseIhealthyvolunteerswithNME- NO!Ifloved-one/friendhadalife-threateningdiseaseandtreatmentoptionswerelimitedthenIwouldrecommendtheyfindoutaboutappropriateclinicaltrial.”• “Oncology,forsure.Lessconfidentaboutotherindications.”• “Thereneedstobemoreinformationforpatientsontrials,andmoretrialsincriticalareas(e.g.autism).”• “Iwouldforsurerecommendparticipationinatrial,whenthereisenoughinformationgivenontherisk-benefitratio,sideeffectsandotherpotentialtreatmentsoutsideofatrial.”• “IwouldrecommendEXPLORINGclinicaltrialresearchparticipationbasedontheethicsappliedbythecompaniesthatgenerallysponsorandexecutethem,butclinicalresearchcomeswithinherentrisk;thepotentialrisksneedtobewellunderstoodbeforecommitting.”
SponsorN=102,CRON=85Q:Basedonyourexperience,wouldyourecommendclinicalresearchparticipationtoalovedoneorfriend?
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AQCMemberSurvey:Perceptionsof
ClinicalResearchQuality
74
PerceptionsofQualityOverTimeThoughtherecontinuestobeadifferencebetweenCROsatisfactionwithqualitydeliveredandsatisfactionwithqualityreceivedamongSponsors,anupwardtrendinSponsorratingsisdrivingamovetowardsconvergenceatanoverallhigherlevelofsatisfactionwithqualitydeliveredascomparedto2012.
SponsorN=101,CRON=85SponsorQ:ThinkingaboutyourexperienceswithClinicalServiceProvidersyouworkedwithin2015,howsatisfiedareyouwith…thequalitydeliveredbyyourClinicalServiceProviders?ProviderQ:Thinkingaboutyourexperiencesin2015,howsatisfiedareyouwith…thequalitythatyourcompanydeliveredtoSponsors?
2%18%
5%
13%
5%
55%
54%
12%
36%
Sponsor CRO
5
4
3
2
1
Mean: 3.6 4.2
Verysatisfied
Verydissatisfied 3.3 3.2 3.1
3.43.6
3.84.0 4.1 4.2 4.2
2012 2013 2014 2015 2016
Sponsor CRO
MeanRatingTrend
75
SatisfactiononKeyRelationshipMetricsSponsorsandCROsarecloselyalignedintheirsatisfactionwithrelationships,howevertheydifferintheirperceptionofsatisfactionwithrespecttoquality,overallworkdeliveredandvalueformoney.
3.9
3.6
3.6
3.3
4.2
4.2
4.3
4.3
Sponsor CROYourrelationships withtheCSPswithwhichyouwork
Yourrelationships withtheSponsorswithwhichyouwork
Thequality deliveredbyyourCSPs
Thequality thatyourcompanyhasdeliveredtoSponsors
TheoverallworkthathasbeendoneforyoubyyourCSPs
TheoverallworkthatyourcompanydeliveredforSponsors
Thevalue thatyouhavereceivedforthemoneyspentonyourCSPs
Thevalue thatyourcompanyhasdeliveredforthemoneyreceivedfromSponsors
SponsorN=92-101,CRON=82-85SponsorQ:ThinkingaboutyourexperienceswithClinicalServiceProvidersyouworkedwithin2015,howsatisfiedareyouwith…ProviderQ:Thinkingaboutyourexperiencesin2015,howsatisfiedareyouwith…
TheAvocaQualityConsortiumbringstogetherquality,outsourcingandoperationalprofessionalsfrommemberpharma,biotech,nicheclinicalserviceproviders,andCROorganizationstoaccelerateandstreamlineclinicaltrialexecutionandimprovequalitythroughindustrycollaboration.
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Thankyou
ContactAvocaat:(609)252-9020
www.theavocagroup.cominfo@theavocagroup.com
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