International Expert-Based Consensus Definition, Staging Criteria, and Minimum Data Elements for Osteoradionecrosis of the Jaw: An Inter-Disciplinary Modified Delphi Study
Authors:   The International ORAL Consortium, Moreno Amy C. , Watson Erin E. , Humbert-Vidan Laia , Peterson Douglas E. , van Dijk Lisanne V , Urbano Teresa Guerrero , Van den Bosch Lisa , Hope Andrew J. , Katz Matthew S. , Hoebers Frank J.P. , Aponte Wesson Ruth A. , Bates James E. , Bossi Paolo , Dayo Adeyinka F. , Doré Mélanie , Fregnani Eduardo Rodrigues , Galloway Thomas J. , Gelblum Daphna Y. , Hanna Issa A. , Henson Christina E. , Kiat-amnuay Sudarat , Korfage Anke , Lee Nancy Y. , Lewis Carol M. , Lynggaard Charlotte Duch , Mäkitie Antti A. , Magalhaes Marco , Mowery Yvonne M. , Muñoz-Montplet Carles , Myers Jeffrey N. , Orlandi Ester , Patel Jaymit , Rigert Jillian M. , Saunders Deborah , Schoenfeld Jonathan D. , Selek Ugur , Somay Efsun , Takiar Vinita , Thariat Juliette , Verduijn Gerda M. , Villa Alessandro , West Nick , Witjes Max J.H. , Won Alex , Wong Mark E. , Yao Christopher M.K.L. , Young Simon W. , Al-eryani Kamal , Barbon Carly E.A. , Buurman Doke J.M. , Dieleman François J. , Hofstede Theresa M. , Khan Abdul Ahad , Otun Adegbenga O. , Robinson John C. , Hum Lauren , Johansen Jorgen , Lalla Rajesh , Lin Alexander , Patel Vinod , Shaw Richard J. , Chambers Mark S. , Ma Daniel , Singh Mabi , Yarom Noam , Mohamed Abdallah Sherif Radwan , Hutcheson Katherine A. , Lai Stephen Y. , Fuller Clifton David 
Published: April 2024

Purpose

Osteoradionecrosis of the jaw (ORNJ) is a severe iatrogenic disease characterized by bone death after radiation therapy (RT) to the head and neck. With over 9 published definitions and at least 16 diagnostic/staging systems, the true incidence and severity of ORNJ are obscured by lack of a standard for disease definition and severity assessment, leading to inaccurate estimation of incidence, reporting ambiguity, and likely under-diagnosis worldwide. This study aimed to achieve consensus on an explicit definition and phenotype of ORNJ and related precursor states through data standardization to facilitate effective diagnosis, monitoring, and multidisciplinary management of ORNJ.

Methods

The ORAL Consortium comprised 69 international experts, including representatives from medical, surgical, radiation oncology, and oral/dental disciplines. Using a web-based modified Delphi technique, panelists classified descriptive cases using existing staging systems, reviewed systems for feature extraction and specification, and iteratively classified cases based on clinical/imaging feature combinations.

Results

The Consortium ORNJ definition was developed in alignment with SNOMED-CT terminology and recent ISOO-MASCC-ASCO guideline recommendations. Case review using existing ORNJ staging systems showed high rates of inability to classify (up to 76%). Ten consensus statements and nine minimum data elements (MDEs) were outlined for prospective collection and classification of precursor/ORNJ stages.

Conclusion

This study provides an international, consensus-based definition and MDE foundation for standardized ORNJ reporting in cancer survivors treated with RT. Head and neck surgeons, radiation, surgical, medical oncologists, and dental specialists should adopt MDEs to enable scalable health information exchange and analytics. Work is underway to develop both a human- and machine-readable knowledge representation for ORNJ (i.e., ontology) and multidisciplinary resources for dissemination to improve ORNJ reporting in academic and community practice settings.