OBJECTIVE
Core outcome sets (COSs) are needed to promote data consistency across studies as well as data synthesis and comparability. The goal of the current study was to utilize a modified Delphi process to develop a COS–sciatic injury and neuropathy evaluation (COS-SINE).
METHODS
A five-stage approach was utilized to develop the COS-SINE: stage 1, consortium development; stage 2, literature review to identify potential outcome measures; stage 3, Delphi survey to develop consensus on outcomes for inclusion; stage 4, Delphi survey to develop definitions; and stage 5, consensus meeting to finalize the COS and definitions. The study followed the Core Outcome Set–STAndards for Development recommendations.
RESULTS
The Core Outcomes in Nerve Surgery (COINS) Consortium comprised 23 participants, all neurological surgeons, representing 13 countries. Three participants were excluded on the basis of agreed upon participation rules. The final COS-SINE consisted of 36 data points/outcomes covering the domains of demographics, diagnostics, patient-reported outcomes, motor and sensory outcomes, and complications. Appropriate instruments, methods of testing, and definitions were set. The consensus minimum duration of follow-up was 24 months, with consensus optimal time points for assessment identified as preoperatively and 3, 6, 12, 24, and 36 months postoperatively.
CONCLUSIONS
The COINS Consortium developed a consensus COS and provided definitions, methods of implementation, and time points for assessment. The COS-SINE should serve as a minimum set of data that should be collected in all future neurosurgical studies on sciatic nerve injury and neuropathy. Incorporation of this COS should help improve consistency in reporting and data synthesis and comparability and should minimize outcome-reporting bias.
Thomas J Wilson, Zarina S Ali, Gavin A Davis, Nora F Dengler, Ketan Desai 5, Debora Garozzo, Fernando Guedes, Line G Jacques, Thomas Kretschmer, Mark A Mahan, Rajiv Midha, Ross C Puffer, Lukas Rasulic, Wilson Z Ray, Elias Rizk, Carlos A Rodriguez-Aceves, Yuval Shapira, Mariano Socolovsky, Robert J Spinner, Eric L Zager
Disease Category: Neurology
Disease Name: Sciatic injury, sciatic neuropathy
Age Range: Unknown
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review