OBJECTIVE
Core outcome sets (COSs) are needed to promote data consistency across studies as well as data synthesis and comparability. The aim of the current study was to use a modified Delphi process to develop a COS for lateral femoral cutaneous neuropathy (LFCN), hereafter COS-LFCN.
METHODS
A 5-stage approach was used to develop the COS-LFCN: 1) consortium development, 2) literature review to identify potential outcome measures, 3) Delphi survey to develop consensus on outcomes for inclusion, 4) Delphi survey to develop definitions, and 5) consensus meeting to finalize the COS and definitions. This study followed the Core Outcome Set - STAndards for Development, (COS-STAD) recommendations.
RESULTS
The Core Outcomes in Nerve Surgery (COINS) Consortium comprised 25 participants, all neurological surgeons, representing 14 countries. The final COS-LFCN consisted of 41 factors and outcomes covering domains of demographics, diagnostics, patient-reported outcomes, motor/sensory outcomes, and complications. Appropriate instruments, methods of testing, and definitions were set. The consensus minimum duration of follow-up was 12 months, with the consensus optimal time points for assessment being preoperatively and 3, 6, and 12 months postoperatively.
CONCLUSIONS
The COINS Consortium developed a consensus COS for LFCN and provided definitions, methods of implementation, and time points for assessment. The COS-LFCN should serve as the minimum data to be collected in all future neurosurgical studies on LFCN. Incorporation of this COS will help improve consistency in reporting, data synthesis and comparability, and minimize outcome reporting bias.
Thomas J. Wilson, Zarina S. Ali, Gavin A. Davis, Nora F. Dengler, Ketan Desai, Debora Garozzo, Fernando Guedes, Christian P. G. Heinen, Jennifer Hong, Line G. Jacques, Ekkapot Jitpun, Thomas Kretschmer, Mark A. Mahan, Rajiv Midha, Willem Pondaag, Ross C. Puffer, Lukas Rasulic, Wilson Z. Ray, Elias Rizk, Carlos A. Rodriguez-Aceves, Yamaan S. Saadeh, Yuval Shapira, Mariano Socolovsky, Robert J. Spinner and Eric L. Zager, on behalf of the Core Outcomes in Nerve Surgery Consortium
Disease Category: Neurology
Disease Name:
Age Range: 18 - 120
Sex:
Nature of Intervention: Surgery
- Clinical experts
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Literature review