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Towards early evaluation of surgical innovations using an integrated approach:SURGE

Projectomschrijving

Evaluatie chirurgische innovaties

Om dokters, patiënten, beleidsmakers en fabrikanten te helpen om geïnformeerde keuzes te maken met betrekking tot de ontwikkeling van chirurgische innovaties die effectief, betaalbaar en van toegevoegde waarde zijn, hebben we methoden nodig die de evaluatie vanaf een zeer vroege fase mogelijk maken. Dit project beoogt dergelijke methoden te ontwikkelen, testen en valideren.

Towards early evaluation of surgical innovations using an integrated approach: SURGE

Evaluating Surgical Innovations

To help healthcare professionals, patients, policy makers, and manufacturers to make informed choices about the development, adoption and use of surgical innovations, we need scientific methods that enable the evaluation as from a very early phase. This project aims to establish such a novel and comprehensive methodology.

Producten

Titel: Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?
Auteur: Páez A, Rovers M, Hutchison K, Rogers W, Vasey B, McCulloch P; IDEAL Collaboration.
Magazine: Ann Surg
Begin- en eindpagina:
Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8746919/pdf/ansu-275-0324.pdf
Titel: Innoveer! (maar bezint eer ge begint)
Auteur: Fred Hermsen
Magazine: Magazine Medisch Specialist
Begin- en eindpagina:
Link: https://demedischspecialist.nl/magazine-0/magazine-medisch-specialist-sept-2022
Titel: Arthroscopic partial meniscectomy vs non-surgical or sham treatment in patients with MRI-confirmed degenerative meniscus tears: a systematic review and meta-analysis with individual participant data from 605 randomised patients
Auteur: Wijn SRW, Hannink G, Østerås H, Risberg MA, Roos EM, Hare KB, van de Graaf VA, Poolman RW, Ahn HW, Seon JK, Englund M, Rovers MM.
Magazine: Osteoarthritis Cartilage
Begin- en eindpagina:
Link: https://www.oarsijournal.com/action/showPdf?pii=S1063-4584%2823%2900003-1
Titel: Development of a decision analytical framework to prioritise operating room capacity: lessons learnt from an empirical example on delayed elective surgeries during the COVID-19 pandemic in a hospital in the Netherlands
Auteur: Rovers MM, Wijn SRW, Grutters JPC, Metsemakers SJJPM, Vermeulen RJ, van der Pennen R, Berden BJJM, Gooszen HG, Scholte M, Govers TM; EBS-group collaborators.
Magazine: BMJ Open
Begin- en eindpagina:
Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8995574/pdf/bmjopen-2021-054110.pdf
Titel: IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage
Auteur: Marcus HJ, Bennett A, Chari A, Day T, Hirst A, Hughes-Hallett A, Kolias A, Kwasnicki RM, Martin J, Rovers M, Squire SE, McCulloch P.
Magazine: Ann Surg
Begin- en eindpagina:
Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8683254/pdf/ansu-275-0073.pdf
Titel: Learning Curve Analysis for Intracorporeal Robot-assisted Radical Cystectomy: Results from the EAU Robotic Urology Section Scientific Working Group
Auteur: Wijburg CJ, Hannink G, Michels CTJ, Weijerman PC, Issa R, Tay A, Decaestecker K, Wiklund P, Hosseini A, Sridhar A, Kelly J, d'Hondt F, Mottrie A, Klaver S, Edeling S, Dell'Oglio P, Montorsi F, Rovers MM, Witjes JA.
Magazine: Eur Urol Open Sci.
Begin- en eindpagina:
Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9068730/
Titel: In deze e-learning leren innovatoren en zorgprofessionals meer over de uitdaging om in een vroeg stadium te onderzoeken of en hoe een medische innovatie toegevoegde waarde kan bieden.
Link: https://surginginnovation.com/
Titel: Om de uitkomsten van ons project ook met het grotere publiek te kunnen delen hebben middels een samenwerking met de KABK een kunstproject ontwikkeld waarmee we komend jaar in een museum (en/of op een festival) mee hopen te exposeren.
Link: https://bourgondien.nl/clients/radboud/survey/ (single player version) EN https://bourgondien.nl/clients/radboud/survey/p (mutliple player)
Titel: Exploring the value of innovations: Methods for early health economic modlling in surgical innovation
Auteur: Mirre Scholte
Link: https://www.publicatie-online.nl/publicaties/mirre-scholte/
Titel: Stakeholder involvement in surgical innovation: Everybody’s devices
Auteur: Kas Woudstra

Verslagen


Samenvatting van de aanvraag

SURGE aims to establish novel and comprehensive methodology to evaluate the value of surgical innovations throughout all stages of development. Whilst surgical innovations hold strong appeal for professionals and patients, it is currently impossible to predict or establish their role in quality improvement of surgical care. The current surgical innovation pathway is too long, too expensive, not regulated, and lacking an evidence-based evaluation approach. I have developed new approaches evaluating to surgical innovations from as early as their conception. This proposal builds on this development by considering specific challenges in surgical research. I will develop methodologies that enable: 1. a view, shared by all stakeholders, including patients, on where, how and by whom surgical technologies should be developed; 2. early health-economic evaluation of surgical innovations, taking into account learning curve associated morbidity and costs; 3. individual decision making by considering the risks, benefits, needs, preferences and values for individual patients; 4. guidance on how to integrate and apply the new methodologies This project is highly innovative as it adopts a transdisciplinary approach linking different fields and integrating methodological innovations (i.e. interactive evaluations, headroom analyses, comparative effectiveness studies, and an evidence-based approach to decision making in individual patients) with direct application to real-world surgical innovations. I am in a unique position to address these challenges since I have performed visionary and innovative work on the early assessment of surgical innovations, which transverses the boundaries of traditional disciplines, such as surgery, health technology assessment, epidemiology and policy making. My position as an epidemiologist, operating from within the surgical disciplines and my extensive national and international network are exceptional and critical to delivering this work. This proposal will add to the “science of surgical evaluation”, and allow for development of surgical innovations that are affordable, effective, and of value for the patient.

Onderwerpen

Kenmerken

Projectnummer:
91818617
Looptijd: 100%
Looptijd: 100 %
2018
2023
Gerelateerde subsidieronde:
Projectleider en penvoerder:
M.M. Rovers PhD
Verantwoordelijke organisatie:
Radboud Universitair Medisch Centrum