Integrating a randomized controlled trial with a parallel observational cohort study in cervical spine surgery insights from the foraminotomy ACDF cost-effectiveness trial (FACET)
Randomization did not influence clinical outcomes for cervical surgery patients. Combining RCT with the observational cohort increased statistical power, external validity and robustness. Our findings support the value of observational methods as a complement to RCTs, especially when a large number of patients refuse RCT participation and high dropout and crossover rates are expected.
Authors
- Katalin Tamási (ORCID: https://orcid.org/0000-0001-9391-4597)
- MF Reneman
- Jos M.A. Kuijlen (ORCID: https://orcid.org/0000-0002-2907-5853)
- Van Thanh Dau (ORCID: https://orcid.org/0000-0002-8242-9884)
- Anne E.H. Broekema (ORCID: https://orcid.org/0000-0002-2657-7540)
- Deise Vimaana Santos de Souza Simões (ORCID: https://orcid.org/0009-0007-4166-9308)
- Remko Soer (ORCID: https://orcid.org/0000-0003-4154-1711)
- A. Van
Institutions
- University Medical Center Groningen (NL)
- University of Groningen (NL)
Publication Details
- Journal
- The Spine Journal
- Published
- 2025-03-25
- DOI
- https://doi.org/10.1016/j.spinee.2025.03.002
- Citations
- 1
- Primary Topic
- Spine and Intervertebral Disc Pathology
- Type
- article
- Field-Weighted Citation Impact
- 1.47
Funders
- NuVasive
- ZonMw