Cargando…

Creation of objective performance criteria among medical devices

OBJECTIVES: Objective performance criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of class III medical devices. Thus far, published guidance on the creation of OPC has been clinical area-specific. This study aimed to capture reflections from key s...

Descripción completa

Detalles Bibliográficos
Autores principales:	Gressler, Laura Elisabeth, Marinac-Dabic, Danica, dosReis, Susan, Goodney, Philip, Mullins, C. Daniel, Shaya, Fadia
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2022
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345051/ https://www.ncbi.nlm.nih.gov/pubmed/35989873 http://dx.doi.org/10.1136/bmjsit-2021-000106

Ejemplares similares

Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies
por: Nieuwenhuijse, Marc J., et al.
Publicado: (2023)

A Quantitative Framework to Identify and Prioritize Opportunities in Biomedical Product Innovation: A Proof-of-Concept Study
por: Gressler, Laura Elisabeth, et al.
Publicado: (2023)

Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence
por: Sedrakyan, Art, et al.
Publicado: (2011)

Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network
por: LeRoy, Hartley, et al.
Publicado: (2022)

Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
por: Long, Cynthia, et al.
Publicado: (2022)

Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices
por: Webber, Christina M., et al.
Publicado: (2023)

Association of Criminal Statutes for Opioid Use Disorder With Prevalence and Treatment Among Pregnant Women With Commercial Insurance in the United States
por: Gressler, Laura E., et al.
Publicado: (2019)

Association of Sex With Risk of 2-Year Revision Among Patients Undergoing Total Hip Arthroplasty
por: Chen, Amanda, et al.
Publicado: (2021)

Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies
por: Baird, Courtney E, et al.
Publicado: (2022)

Two-Year Revision Rates in Total Ankle Replacement Versus Ankle Arthrodesis: A Population-Based Propensity-Score-Matched Comparison from New York State and California
por: Randsborg, Per-Henrik, et al.
Publicado: (2022)

Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network
por: Baird, Courtney E, et al.
Publicado: (2022)

Editorial: Real-World Evidence of Pediatric Exposure to Psychopharmacologic Medications
por: Zito, Julie M., et al.
Publicado: (2022)

IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage
por: Cook, Jonathan A, et al.
Publicado: (2013)

232 Psychotropic Medication Use Before Cancer Diagnosis Among US Adolescents and Young Adults
por: Onasanya, Oluwadamilola, et al.
Publicado: (2022)

Orthopedic Coordinated Registry Network (Ortho-CRN): advanced infrastructure for real-world evidence generation
por: Gressler, Laura Elisabeth, et al.
Publicado: (2022)

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks
por: Sedrakyan, Art, et al.
Publicado: (2022)

Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing
por: Matheny, Michael E, et al.
Publicado: (2011)

Development of a coordinated registry network for pelvic organ prolapse technologies
por: Baird, Courtney E, et al.
Publicado: (2022)

Performance objectives and criteria for conducting DOE environmental audits
por: United States. Department of Energy
Publicado: (1992)

Performance objectives and criteria for conducting DOE environmental audits
por: United States. Department of Energy
Publicado: (1994)

Complexity and Continuity of Treatments Among Privately Insured Youth Diagnosed with Bipolar Disorder
por: Evans-Lacko, Sara, et al.
Publicado: (2010)

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter–defibrillators
por: Ross, Joseph S, et al.
Publicado: (2017)

Cardiovascular Risk of Concomitant Use of Atypical Antipsychotics and Stimulants Among Commercially Insured Youth in the United States
por: Zhang, Chengchen, et al.
Publicado: (2021)

Elements, norms and criteria necessary for the creation of a termbase :descriptive process/
por: González Quiróz, E. Haroldo
Publicado: (2003)

Creation of mutants by using centrality criteria in social network analysis
por: Takan, Savaş
Publicado: (2020)

Diabetic retinopathy
por: Shaya, Fadia T, et al.
Publicado: (2007)

Predicting Factors of Depression, Antidepressant Use and Positive Response to Antidepressants in Perinatal and Postpartum Women
por: Vu, Huyen, et al.
Publicado: (2017)

A Purdue icon: creation, life, and legacy
por: Mullins, James L
Publicado: (2019)

Exploring stimulant treatment in ADHD: narratives of young adolescents and their parents
por: Charach, Alice, et al.
Publicado: (2014)

Bridging the Gap Between Pharmacoeconomics and the Real-World Practice of Managed Care Pharmacy
por: Shaya, Fadia T., et al.
Publicado: (2007)

Summary Quality Scores for Pharmacoeconomic Studies: Balancing Validity With Need
por: Shaya, Fadia T., et al.
Publicado: (2003)

Particle creation in gravitational collapse to a horizonless compact object
por: Harada, Tomohiro, et al.
Publicado: (2018)

The Importance of Collaboration in Pursuit of Patient-Centered Value Assessment
por: Linthicum, Mark T., et al.
Publicado: (2020)

Building the foundation for a modern patient-partnered infrastructure to study temporomandibular disorders
por: Gressler, Laura Elisabeth, et al.
Publicado: (2023)

Developing a modular architecture for creation of rule-based clinical diagnostic criteria
por: Hong, Na, et al.
Publicado: (2016)

Impact of early surveillance on safety signal identification in the CathPCI DELTA study
por: Majithia, Arjun, et al.
Publicado: (2020)

Cardiovascular event-free survival after adjuvant radiation therapy in breast cancer patients stratified by cardiovascular risk
por: Onwudiwe, Nneka C, et al.
Publicado: (2014)

The central role of Fas‐ligand cell signaling in inflammatory lung diseases
por: DosReis, G. A., et al.
Publicado: (2007)

How scientists interpret and address funding criteria: value creation and undesirable side effects
por: O’Kane, Conor, et al.
Publicado: (2022)

Food safety objectives, criteria, ranking and hierarchization
por: Liuzzo, Gaetano, et al.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_1c0c5o28kafr9h238dngsa0utc