A Systematic Review—Informed Guidance for Reporting Outcomes in Cranioplasty Studies (ROCS): The ROCS Statement—A Reporting Guideline
Marcio Y. Ferreira, Leonardo J.C. Cardoso, Luis F. Paleare, Gabriel de Almeida Monteiro, Alleh Nogueira, Nicole Sanches, Raphael Bertani, Wellingson Paiva, Jamie S. Ullman, Zachary L. Hickman, Ernest J. Barthélemy, Netanel Ben-ShalomBackground:
Research on cranioplasty has grown substantially in recent years; however, corresponding advances in its methodological rigor have lagged behind, resulting in a heterogeneous body of literature with a lack of standardization in the reporting of outcomes that hinders cumulative evidence synthesis. By systematically reviewing a sample of the cranioplasty literature, the authors aimed to evaluate reporting practices in these studies and propose a reporting guideline focusing on essential elements to ensure reproducibility and comparability.
Methods:
Following PRISMA guidelines, the authors systematically searched PubMed, Embase, and the Cochrane Library databases. Eligible studies were observational or randomized, reported clinical and/or surgical outcomes related to cranioplasty for selected indications, included over 400 patients, and were published in English in the last 10 years. The assessment was structured around 7 key domains: (1) baseline characteristics of the patient sample; (2) study methodology and reporting guidelines; (3) key concepts definition; (4) procedure details; (5) intraoperative details; (6) postoperative and follow-up details; and (7) limitations and conclusion.
Results:
Twenty-nine studies comprising 39,236 cranioplasty patients were included. Our assessment revealed substantial gaps in reporting practices across the evaluated literature, including deficiencies across all domains. The ROCS Statement was developed, consisting of 55 items distributed across 7 domains, focusing on cranioplasty-specific surgical and clinical outcomes and designed as a complement to established general reporting frameworks.
Conclusion:
This study identified important deficiencies in reporting practices within a systematically selected sample of the cranioplasty literature. As the field continues to evolve, standardized and transparent reporting is essential to support evidence generation and improve patient care. The ROCS Statement represents an effort in this direction and has the potential to enhance reproducibility, comparability, transparency, and the level of evidence in future studies.