Constructive Technology Assessment (CTA) as a tool in coverage with evidence development: the case of the 70-gene prognosis signature for breast cancer diagnostics.
OBJECTIVE
Constructive Technology Assessment (CTA) is a means to guide early implementation of new developments in society, and can be used as an evaluation tool for Coverage with Evidence Development (CED). We used CTA for the introduction of a new diagnostic test in the Netherlands, the 70-gene prognosis signature (MammaPrint) for node-negative breast cancer patients.


METHODS
Studied aspects were (organizational) efficiency, patient-centeredness and diffusion scenarios. Pre-post structured surveys were conducted in fifteen community hospitals concerning changes in logistics and teamwork as a consequence of the introduction of the 70-gene signature. Patient-centeredness was measured by questionnaires and interviews regarding knowledge and psychological impact of the test. Diffusion scenarios, which are commonly applied in industry to anticipate on future development and diffusion of their products, have been applied in this study.


RESULTS
Median implementation-time of the 70-gene signature was 1.2 months. Most changes were seen in pathology processes and adjuvant treatment decisions. Physicians valued the addition of the 70-gene signature information as beneficial for patient management. Patient-centeredness (n = 77, response 78 percent): patients receiving a concordant high-risk and discordant clinical low/high risk-signature showed significantly more negative emotions with respect to receiving both test-results compared with concordant low-risk and discordant clinical high/low risk-signature patients. The first scenario was written in 2004 before the introduction of the 70-gene signature and identified hypothetical developments that could influence diffusion; especially the "what-if" deviation describing a discussion on validity among physicians proved to be realistic.


CONCLUSIONS
Differences in speed of implementation and influenced treatment decisions were seen. Impact on patients seems especially related to discordance and its successive communication. In the future, scenario drafting will lead to input for model-based cost-effectiveness analysis. Finally, CTA can be useful as a tool to guide CED by adding monitoring and anticipation on possible developments during early implementation, to the assessment of promising new technologies.
Retèl
Valesca P
VP
Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. v.retel@nki.nl
Bueno-de-Mesquita
Jolien M
JM
Hummel
Marjan J M
MJ
van de Vijver
Marc J
MJ
Douma
Kirsten F L
KF
Karsenberg
Kim
K
van Dam
Frits S A M
FS
van Krimpen
Cees
C
Bellot
Frank E
FE
Roumen
Rudi M H
RM
Linn
Sabine C
SC
van Harten
Wim H
WH
D020811:Biomedical Technology / Q000191:economics*; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics* / Q000503:physiopathology; D004059:Diffusion of Innovation; D017598:Efficiency, Organizational; D005260:Female; D006801:Humans; D009426:Netherlands; D018802:Patient-Centered Care; D011379:Prognosis; D013673:Technology Assessment, Biomedical / Q000191:economics*