厚生労働省科学研究班開発
患者報告アウトカム(Patient-Reported Outcome:PRO)
使用についてのガイダンス集
［ 目次 ］
臨床試験のためのPatient-Reported Outcome（PRO）使用ガイダンス
略語一覧
- ALCOA
- Attributable, Legible, Contemporaneous, Original, Accurate
- App
- Application program
- ASCOT
- Adult Social Care Outcomes Toolkit
- AUC
- Area Under the Curve
- BPI-SF
- Brief Pain Inventory – Short Form
- BYOD
- Bring Your Own Device
- CAT
- Computer Adaptive Testing
- CHMP
- Committee for Proprietary Medicinal Products
- ClinRO
- Clinician-Reported Outcome
- COA
- Clinical Outcome Assessment
- COI
- Concept of Interest
- COMET
- Core Outcome Measure in Effectiveness Trials
- COPD
- Chronic Obstructive Pulmonary Disease
- COREQ
- Consolidated criteria for reporting qualitative research
- COS
- Core Outcome Sets
- COSMIN
- COnsensus-based Standards for the selection of health status Measurement Instruments
- COU
- Concept of Use
- CRF
- Case Report Form
- CSV
- Computerized System Validation
- DCOA
- Division of Clinical Outcome Assessment
- DIA
- Drug Information Association
- EDC
- Electronic Data Capture
- EMA
- European Medicines Agency
- EORTC-QLQ
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire
- ePRO
- electronic Patient-Reported Outcome
- EQ-5D
- EuroQol 5 dimension
- ER/ES
- Electronic Record / Electronic Signature
- ERIQA
- European Regulatory Issues on Quality of life Assessment
- E-RS
- Evaluating Respiratory Symptoms
- EXACT
- Exacerbation of Chronic Pulmonary Disease Tool
- FACT-G
- Functional Assessment of Cancer Therapy scale - General
- FDA
- Food and Drug Administration
- GCP
- Good Clinical Practice
- GPS
- Global Positioning System
- HIV
- Human Immunodeficiency Virus
- HRQL
- Health-Related Quality of Life
- HTA
- Health Technology Assessment
- HUI
- Health Utilities Index
- HSUV
- Health-State Utility Values
- HTML
- Hyper Text Markup Language
- ICC
- Intra-class Correlation Coefficient
- ICH
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- ICHOM
- International Consortium for Health Outcome Measurement
- IRT
- Item Response Theory
- ISOQOL
- International Society of Quality of Life Research
- ISPOR
- International Society for Pharmacoeconomics and Outcomes Research
- IVRS
- Inter Voice Response System
- KCCQ
- Kansas City Cardiomyopathy Questionnaire
- MID
- Minimal Important Difference
- NCI
- National Cancer Institute
- NIH
- National Institutes of Health
- NRS
- Numeric Rating Scale
- ObsRO
- Observer-Reported Outcome
- ODAC
- Oncologic Drugs Advisory Committee
- ORR
- Overall Response Rate
- OS
- Operating System
- PBM
- Preference-Based Measure
- PedsQL
- Pediatric Quality of Life Inventory
- PerfO
- Performance Outcome
- PFDD
- Patient-Focused Drug Development
- PFS
- Progression-Free Survival
- PhRMA HOC
- Health Outcomes Committee of the Pharmaceutical Research and Manufacturers of America
- PNQ
- Patient Neurotoxicity Questionnaire
- PPI
- Patient and Public Involvement
- PRO
- Patient-Reported Outcome
- PRO-CTCAE
- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
- PROMIS
- Patient-Reported Outcomes Measurement Information System
- PS
- Performance Status
- QALY
- Quality-Adjusted Life Year
- QOL
- Quality of Life
- REDCap
- Research Electronic Data Capture
- SD
- tandard Deviation
- SEALD
- Study Endpoints and Labeling Development
- SEM
- Standard Error of Measurement
- SF-36
- Medical Outcome Study 36-item Short-Form Health Survey
- SISAQOL-IMI
- Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data - Innovative Medicines Initiative
- SMDDS
- Symptoms of Major Depressive Disorder Scale
- SRQR
- Standards for Reporting Qualitative Research
- TDD
- Time to Definitive Deterioration
- VAS
- Visual Analogue Scale