TY - JOUR
T1 - Best practice considerations on the assessment of robotic assisted surgical systems
T2 - results from an international consensus expert panel
AU - Erskine, J.
AU - Abrishami, P.
AU - Charter, R.
AU - Cicchetti, A.
AU - Culbertson, R.
AU - Faria, E.
AU - Hiatt, J. C.
AU - Khan, J.
AU - Maddern, G.
AU - Patel, A.
AU - Rha, K. H.
AU - Shah, P. C.
AU - Sooriakumaran, P.
AU - Tackett, S.
AU - Turchetti, G.
AU - Chalkidou, A.
N1 - Publisher Copyright:
© The Author(s), 2023. Published by Cambridge University Press.
PY - 2023/6/5
Y1 - 2023/6/5
N2 - Background Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. Methods A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. Results A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. Conclusions Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.
AB - Background Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. Methods A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. Results A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. Conclusions Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.
UR - http://www.scopus.com/inward/record.url?scp=85162109615&partnerID=8YFLogxK
U2 - 10.1017/s0266462323000314
DO - 10.1017/s0266462323000314
M3 - Article
C2 - 37272397
AN - SCOPUS:85162109615
SN - 0266-4623
VL - 39
JO - International Journal of Technology Assessment in Health Care
JF - International Journal of Technology Assessment in Health Care
IS - 1
M1 - e39
ER -