Making a final oncological clinical diagnosis: are the “rules of the game” so clear?

Introduction. International Statistical Classification of Diseases and Related Health Problems (ICD-10) standardizes approaches to the formation of a pathological diagnosis. It is assumed the principles for forming the final clinical diagnosis to be similar to the pathoanatomical ones, but not in all clinical situations doctors have the opportunity to follow this rule.The purpose of the study. Assessing the orientation of medical personnel in the rules for forming the final clinical diagnosis; analysis of regulations, accounting documents and methodological recommendations for the formation of a final clinical diagnosis.Materials and methods. The study used statistical data from the largest oncology clinic in Europe for 2022. An analysis of defects in the final clinical diagnosis was carried out (the second class of diseases — neoplasms, ICD-10). Analytical and statistical methods were used. Additionally, regulations, accounting documents, classifications and methodological recommendations of professional communities were studied — about issues of formalizing the clinical diagnosis in cancer patients.Results. Analysis of the studied regulations, accounting documents and methodological recommendations showed the presence of a legal gap and different interpretations of the instructions in the second volume of ICD-10 by the professional regarding the formation and coding of the final diagnosis in oncology.Research limitations. The study has age and nosological restrictions; it concerns the population diagnosed with category C00–D48 aged of 18 years or older.Conclusion. The described examples of different approaches to coding clinical and pathological diagnoses call into question the statement about uniform rules for forming diagnoses. This issue is very extensive and undoubtedly requires detailed study, both at the level of the expert community and at the legislative level. The development of independent, easy-to-use recommendations for the design and coding of a clinical diagnosis can have a positive impact on reducing the number of diagnostic defects in primary medical documentation.Compliance with ethical standards. The study was approved by the Ethics Committee National Medical Research Center of Oncology. Protocol No. 14 dated December 16, 2024. All participants gave informed voluntary written consent to participate in the study.Contribution of the authors: Voroshilova E.A. — concept and design of the study, collection and processing of material, statistical processing, compilation of a list of references, approval of the final version of the article; Shekelashvili A.I., Eroshin Yu.V. — critical revision of the draft manuscript with the introduction of valuable comments of intellectual content. All authors are responsible for the integrity of all parts of the manuscript and approval of its final version. Funding. The study had no sponsorship. Conflict of interest. The authors declare no conflict of interest.Received: November 15, 2024 / Revised: January 22, 2025 / Accepted: February 19, 2025 / Published: October 31, 2025

clinical diagnosis, International Statistical Classification of Diseases and Related Health Problems, coding, primary multiple tumors, neoplasms of undetermined or unknown nature