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Ruolo infermieristico nei trials clinici
Convegno REPRete Ematologica Pediatrica
Maria Chiara Ariotti
AOU Ospedale S.Luigi Orbassano 23 maggio 2014
Team multiprofessionale
Gli attori della sperimentazione. P.Culotta, L. Callegaro. La ricerca clinica 2008 Ed. medico scientifiche
Autorità regolatoria
soggetto
sponsorricercatore
data manager
Monitor di ricerca clinica
infermiere di
ricerca clinica
Comitato etico indipendente
Steering
committee Data safety and
monitoring committee
CENTRE _________________________________________________________
Shire protocol items PHYSICIAN NURSE DATA MANAGER OTHER specify Comments
Screening phaseP1 Verify Patient Eligibility
P2 Update Medical History
P3 Informed Consent collection
P4 Inclusion/Exclusion criteria collection
P5 Review Medical History
P6 Complete PE
P7 Test for visual acuity
P8 Eye examination with an ophthalmoscope
P9 12-lead ECG
P10 Vital Signs (HR, BP, RR, T, W)
P11 Height sitting and standing
P12 Concomitant Medications
P13 Blood sampling
P14 UA with Microscopy
P15 Urine Pregnancy Test
P16 MRI (FerriScan®, T2*, R2* and LVEF) scheduling
P17 Audiometry
P18 Enroll using IWR system
Chronic phase
P19 Drug Dosing
P20 PK blood sampling
P21 PK urine sampling
P22 Limited PE
P23 Collect Adverse Events
P24 Collect returned investigational drug
P25 Count pills
P26 Calculate Dosing Period
P27 Dispense drug bottles
P28 Restart previous chelating therapy
Strumento d’indagineCENTRE _________________________________________________________
Clinical Trials Nursing Questionnaire's items (CTNQ)* Screening phase
Q1
Communicate general information about the nature and goals of clinical research to potential
subject
Q2 Prescreen inquiries ( e.g., thelephone calls) for eligibility requirements
Q3 Screen potential subjects for study participation (e.g., review medical history, pathology)
Q4 Ensure all screening eligibility and enrolment procedures are completed
Q5 Provide the potential subject with additional information to help informed decision-making
Q6
Assess the ability and willingness of subjects to follow and complete study procedures and visits
(e.g., time, cost)
Q7 Implement and evaluate strategies to overcome barriers to protocol compliance
Q8 Assist the subject/family in identifying coping strategies for concerns (e.g., role changes)
Q9 Provide patient teaching about the investigational product (e.g., potential side effects)
Q10 Order/obtain the investigational product
Q11 Verify the proper storage and handling of the investigational product
Chronic phaseQ12 Schedule procedures and tests per protocol requirements
Q13 Perform clinical procedures and tests per protocol requirements(e.g.,phlebotomy)
Q14 Ensure the proper specimens collection
Q15 Ensure the proper specimens processing
Q16 Ensure the proper specimens shipment
Q17 Maintain accountability for the investigational product at the study site
Q18 Verify records are maintained of the investigational product
Q19 Assess subject's compliance with the use of the investigational product
Q20 Assess and document identified toxicities/adverse events per protocol-specific criteria
Q21Assess and document the subject’s concurrent use of either complementary or alternative therapies
Q22 Document any deviation from the approved protocol
Q23 Communicate with the Principal Investigator about the progress of the study
Q24 Ensure the long-term follow-up of subjects
Q25 Resolve data queries
Q26 Prepare for regulatory inspections of records and documents
*Heidi E. Ehrenberger, Linda Lillington.Development of a measure to delineate the clinical trials nursing role." In:
Oncology nursing forum 31.3 (may. 2004), E64-8.
CENTRE _________________________________________________________
Shire protocol items PHYSICIAN NURSE DATA MANAGER
Screening phaseP1 Verify Patient Eligibility
P2 Update Medical History
P3 Informed Consent collection
P4 Inclusion/Exclusion criteria collection
P5 Review Medical History
P6 Complete PE
P7 Test for visual acuity
P8 Eye examination with an ophthalmoscope
P9 12-lead ECG
P10 Vital Signs (HR, BP, RR, T, W)
P11 Height sitting and standing
P12 Concomitant Medications
P13 Blood sampling
P14 UA with Microscopy
P15 Urine Pregnancy Test
P16 MRI (FerriScan®, T2*, R2* and LVEF) scheduling
P17 Audiometry
P18 Enroll using IWR system
Chronic phase
P19 Drug Dosing
P20 PK blood sampling
P21 PK urine sampling
P22 Limited PE
P23 Collect Adverse Events
P24 Collect returned investigational drug
P25 Count pills
P26 Calculate Dosing Period
P27 Dispense drug bottles
P28 Restart previous chelating therapy
Compilazione strumento d’indagineEs. Orbassano
Compilazione strumento d’indagineCENTRE _________________________________________________________
Clinical Trials Nursing Questionnaire's items (CTNQ)* PHYSICIAN NURSE DATA MANAGER
Screening phase
Q1
Communicate general information about the nature and goals of clinical research to potential
subject
Q2 Prescreen inquiries ( e.g., thelephone calls) for eligibility requirements
Q3 Screen potential subjects for study participation (e.g., review medical history, pathology)
Q4 Ensure all screening eligibility and enrolment procedures are completed
Q5 Provide the potential subject with additional information to help informed decision-making
Q6
Assess the ability and willingness of subjects to follow and complete study procedures and visits
(e.g., time, cost)
Q7 Implement and evaluate strategies to overcome barriers to protocol compliance
Q8 Assist the subject/family in identifying coping strategies for concerns (e.g., role changes)
Q9 Provide patient teaching about the investigational product (e.g., potential side effects)
Q10 Order/obtain the investigational product
Q11 Verify the proper storage and handling of the investigational product
Chronic phaseQ12 Schedule procedures and tests per protocol requirements
Q13 Perform clinical procedures and tests per protocol requirements(e.g.,phlebotomy)
Q14 Ensure the proper specimens collection
Q15 Ensure the proper specimens processing
Q16 Ensure the proper specimens shipment
Q17 Maintain accountability for the investigational product at the study site
Q18 Verify records are maintained of the investigational product
Q19 Assess subject's compliance with the use of the investigational product
Q20 Assess and document identified toxicities/adverse events per protocol-specific criteria
Q21Assess and document the subject’s concurrent use of either complementary or alternative therapies
Q22 Document any deviation from the approved protocol
Q23 Communicate with the Principal Investigator about the progress of the study
Q24 Ensure the long-term follow-up of subjects
Q25 Resolve data queries
Q26 Prepare for regulatory inspections of records and documents
*Heidi E. Ehrenberger, Linda Lillington.Development of a measure to delineate the clinical trials nursing role." In:
Oncology nursing forum 31.3 (may. 2004), E64-8.
Es. Orbassano
Attività
ideali Figure coinvolte negli studi
N-°
Attività
reali
Impegno
%
Impegno
rispetto
all'ideale
%
Infermiere-Orbassano 14 26% 47%
Infermiere-Cagliari 8 15% 27%
Infermiere-Smirne 4 7% 13%
Infermiere-Genova 9 17% 30%
Infermiere-Milano 6 11% 20%
Medico-Orbassano 42 78% 233%
Medico-Cagliari 45 83% 250%
Medico-Smirne 32 59% 178%
Medico-Genova 36 67% 200%
Medico-Milano 42 78% 233%
Data manager-Orbassano 13 24% 217%
Data manager-Cagliari 22 41% 367%
Data manager-Smirne 16 30% 267%
Data manager-Genova 22 41% 367%
Data manager-Milano / / /
30
18
6
Risultati
Risultati
Rapporto tra impegno reale e ideale(medie + intervallo di confidenza 95%)
Eff. corrente: F(2, 12)=8,9989, p=,00410
6 (DM) 18 (Medico) 30 (Infermiere)
Attività ideali per ruolo
-1,0
-0,5
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
4,0
Rap
po
rto
imp
egn
o r
eale
/idea
le
aderenza al trattamento arruolamenti negli studi attendibilità dei dati raccolti comprensione del consenso
diffidenza perdita follow up ansia nei placebo controllati rischio clinico
+
-
Vantaggi per i soggetti arruolati
Nelson A, Nixon J, Mason S. The role and potential contribution of clinical research nurses to
clinical trials. Journal of Clinical Nursing, 2008 17 (4): 549-57
Ocker BM, Plank DMP The research nurse role in a clinic-based oncology research setting
Cancer Nursing, 2008; 23 (4): 286-94