Abstract
Study design
A cross-sectional stated-preference survey using direct-assessment questions.
Objective
To determine the relative value placed on different outcomes to be used in a pivotal trial for the upper extremity configuration of the Networked Neuroprosthesis (NNP) as well as the tolerance of the expected adverse event profile.
Setting
Academic medical center in the United States.
Methods
Distribution of an online survey to adults living with tetraplegia; extent of agreement with each question/statement was obtaining using a 1–7 Likert scale.
Results
There were 8 statements about potential benefits in arm/hand function; for all statements, more than 70% of participants rated the functions as “1-very important” to regain. There were variable degrees of concern related to risks that could occur during the 30-day post-surgical period and increasing degrees of concern related to risks that could occur in the first 5 years, potentially due to the device, based on the increasing degree of invasiveness of the intervention required to address the event. When analysing the results based on all degrees of interest, more than 64% of responders were interested in getting the NNP with a success rate threshold as low as 50% regardless of time post-injury. Chi-squared analyses revealed some associations between responses and sex, injury level, and injury duration; however, none of these were statistically significant upon post-hoc analysis.
Conclusion
Data here indicate that people with tetraplegia are highly interested in a range of arm/hand functions and are tolerant of expected risks that may be associated with implanted neuroprosthetics.
Sponsorship
The Institute for Functional Restoration funded this project through a sub-contract to K.D. Anderson from a larger Special Projects Award (grant number FP0020773) from the Craig H. Neilsen Foundation.
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Data archiving
All survey questions and answer options as well as the raw data used for all contingency tables are included in the Supplementary Material. A copy of the full dataset can be obtained by contacting the corresponding author.
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Acknowledgements
The authors would like to thank all the individuals living with SCI who took the time to provide input to this study. A special thanks is extended to Dr. Rachel Cowan for statistical advice. An abstract of preliminary analysis of this work has been published in the program book of the 2018 Tetrahand World Congress.
Funding
The Institute for Functional Restoration funded this project through a sub-contract to KDA from a larger Special Projects Award (grant number FP0020773) from the Craig H. Neilsen Foundation.
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Anderson, K.D., Bryden, A.M. & Moynahan, M. Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury. Spinal Cord Ser Cases 5, 68 (2019). https://doi.org/10.1038/s41394-019-0213-9
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DOI: https://doi.org/10.1038/s41394-019-0213-9
