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Welcome to the ECRIN database on outcome measures for medical device trials

Selecting appropriate outcome measures to assess the efficacy and safety of a medical device in a given disease plays a crucial role and can be challenging. This database is established to support researchers in planning, conducting clinical trials and health technology assessments (HTA) on medical devices.

The database allows you to search information on relevant outcomes related to specific medical devices defined a-priori to an evidence synthesis. The information on relevant outcomes in medical device trials were systematically searched and originate mainly from concrete HTAs and other relevant publications, such as systematic reviews and horizon scans published after 2008 and represent the commonly used outcome measures by international institutions involved in HTA (e.g. members of INAHTA, EUnetHTA and non-profit members of HTAi).

In this database you can find information about:

• specific medical devices of risk class IIa, IIb and class III*
• the product names of medical devices
• the disease and related ICD-10 number
• the related body classification, type of intervention and device category
• the outcomes measures
• the source of information

To start searching in the database please select either Filters or Search from the top menu.

About ECRIN WP5

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List of Abbreviations

AF	Atrial fibrillation
AHI	Apnoea/Hypopnoea index
AI	Apnoea index
AIDR	Artificial intervertebral disc replacement
APD	Automated Peritoneal Dialysis
APHAB	Abbreviated Profile of Hearing Aid Benefit
AUC	Area under the curve
BIS	Bispectral Index
BSCVA	Best spectacle-corrected visual acuity
CAD	Computer-aided detection
CAD	Coronary artery disease
CBCT	Cone-beam computed tomography
CE-CCT	Contrast enhanced coronary computed tomography
COSI	Client Oriented Scale of Improvement
CPAP	Continuous Positive Airway Pressure
CRT-D	Cardiac Resynchronisation Therapy including Defibrillator
CT	Computed tomography
CTC	Computed tomographic colonography
CTCAE	Common Terminology Criteria for Adverse Events
CVC	Central venous catheters
CVP	Central venous pressure
DAP	Decision Analytic Protocol
DBS	Deep brain stimulation
DGF	Delayed graft function
DOR	Diagnostic odds ratio
EBCT	Electron beam CT
ECHO	Expected consequences of Hearing Aid Ownership
ECMO	Extracorporeal membrane oxygenation
ECOG	Eastern cooperative oncology group
EECP	Enhanced external counterpulsation
EFM	Electronic fetal monitoring
ELT	Endovenous laser therapy
ESWT	Extracorporeal shock-wave therapy
EUS	Endoscopic ultrasonography
EVAR	Endovascular aneurysm repair
FDG	Fluorine-18-deoxyglucose
FDG-PET	Positron emission tomography with radiotracer F-fluorodeoxyglucose
FES	Functional electrical stimulation
FM	Frequency modulation
FN	False-negative
FP	False-positive
HDR	High dose rate
HIFU	High-intensity focused ultrasound
HRQL	Health related quality of life
HRQoL	Health related quality of life
ICD	Implantable cardioverter defibrillator
IGRT	Image-guided radiotherapy
IIEF-5	International Index of Erectile Function-5
IPG	Neurostimulator/implantable pulse generator
IPL	Intense pulsed light
LDR	Low dose rate
LR+, LR-	Likelihood ratio positive/negative
LTP	Laser trabeculoplasty
MAS	Mandibular advancement splints
MDCT	Multidetector CT
MIBI scan	Tc-hexakis-2-methoxy isobutyl isonitrate scan
MRgFUS	Magnetic resonance imaging guided high intensity focused ultrasound
MRI	Magnetic resonance imaging
NPV	Negative predictive value
NYHA	New York Heart Association Functional Classification
OSAHS	Obstructive sleep apnoea/hypopnoea syndrome
PAC	Pulmonary artery catheter
PECLA	Pumpless extracorporeal lung assist
PET	Positron emission tomography
PICC	Peripherally Inserted Central Venous Catheter
PNF	Primary non-function
PPV	Positive predictive value
PSG	Polysomnography
QALY	Quality-adjusted life-years
QoL	Quality of life
RD	Retinal detachment
RFA	Radiofrequency ablation
RM3	Renal Preservation System
ROC	Receiver operating characteristic
RVOT	Right ventricular outflow tract
SaO2	Oxygen saturation of arterial blood
SCS	Spinal cord stimulation
SIRT	Selective Internal Radiation Therapy
SMART	Scalable Medical Alert Response Technology
SMBG	Self-monitoring of blood glucose
TAVI	Transcatheter aortic valve implantation devices and delivery systems
TN	True-negative
TNM	Classification of Malignant Tumours
TP	True-positive
TRD	Tongue-retaining devices
VADs	Ventricular assist devices
VNS	Vagus nerve stimulation
WOMAC	Western Ontario and McMaster Universities Osteoarthritis Index
x-ray	X-radiation; Electromagnetic radiation
YAG-laser	Yttrium aluminium garnet-laser

Sources

• [1] MedLinePlus Health Topics
• [2] Classification of medical devices