Validation of the Modena bleeding score in endoscopic sinus surgery / Validação do escore de sangramento de Modena em cirurgia endoscópica dos seios paranasais

Abstract Introduction: The Modena bleeding score is a categorical rating scale that allows the assessment of the surgical field in relation to bleeding during endoscopic surgery. It has recently been presented and validated in the field of endoscopic ear surgery by the present authors. The Modena bleeding score provides five grades for rating the surgical field during endoscopic procedures (from grade 1 - no bleeding to grade 5 - bleeding that prevents every surgical procedure except those dedicated to bleeding control). Objective: The aim of this study was to validate the Modena bleeding score in the setting of endoscopic sinus surgery. Methods: Fifteen three-minute videos of endoscopic sinus surgery procedures (each containing three bleeding situations) were evaluated by 15 specialists, using the Modena bleeding score. Intra and inter-rater reliability were assessed, and the clinical validity of the Modena bleeding score was calculated using a referent standard. Results: The data analysis showed an intra-rater reliability ranging from 0.6336 to 0.861. The inter-rater reliability ranged from 0.676 to 0.844. The clinical validity was α = 0.70; confidence limits: 0.64 - 0.75, corresponding to substantial agreement. Conclusion: The Modena bleeding score is an effective method to score bleeding during endoscopic sinus surgery. Its application in future research could facilitate the performance and efficacy assessment of surgical techniques, materials or devices aimed to bleeding control during endoscopic sinus surgery.

Resumo Introdução: O escore de sangramento de Modena é uma escala de classificação de categorias que permite a avaliação do campo cirúrgico em relação ao sangramento durante a cirurgia endoscópica. Recentemente, ele foi apresentado e validado no campo da cirurgia endoscópica otológica pelos presentes autores. O escore de sangramento de Modena fornece cinco graus para classificação do campo cirúrgico durante procedimentos endoscópicos (de grau 1 - Sem sangramento até grau 5 - Sangramento que impede todos os procedimentos cirúrgicos, exceto aqueles dedicados ao controle de sangramento). Objetivo: Validar o escore de sangramento de Modena no contexto da cirurgia endoscópica nasossinusal. Método: Foram avaliados por 15 especialista 15 vídeos de três minutos de procedimentos de cirurgia endoscópica nasossinusais (cada um com três situações de sangramento), com o uso do escore de sangramento de Modena. A confiabilidade intra e interexaminador foi avaliada e a validade clínica do escore de sangramento foi calculada com um padrão de referência. Resultados: A análise dos dados mostrou confiabilidade intraexaminador que variou de 0,6336 a 0,861. A confiabilidade interexaminador variou de 0,676 a 0,844. A validade clínica foi α = 0,70; limites de confiança: 0,64-0,75, correspondeu a concordância substancial. Conclusão: O escore de sangramento de Modena é um método eficaz para avaliar o sangramento durante a cirurgia endoscópica nasossinusal. Sua aplicação em pesquisas futuras pode facilitar o desempenho e a avaliação da eficácia de técnicas cirúrgicas, do material ou dos dispositivos destinados ao controle de sangramento durante essas cirurgias.

Validation of the Modena bleeding score in endoscopic sinus surgery.

INTRODUCTION: The Modena bleeding score is a categorical rating scale that allows the assessment of the surgical field in relation to bleeding during endoscopic surgery. It has recently been presented and validated in the field of endoscopic ear surgery by the present authors. The Modena bleeding score provides five grades for rating the surgical field during endoscopic procedures (from grade 1 - no bleeding to grade 5 - bleeding that prevents every surgical procedure except those dedicated to bleeding control). OBJECTIVE: The aim of this study was to validate the Modena bleeding score in the setting of endoscopic sinus surgery. METHODS: Fifteen three-minute videos of endoscopic sinus surgery procedures (each containing three bleeding situations) were evaluated by 15 specialists, using the Modena bleeding score. Intra and inter-rater reliability were assessed, and the clinical validity of the Modena bleeding score was calculated using a referent standard. RESULTS: The data analysis showed an intra-rater reliability ranging from 0.6336 to 0.861. The inter-rater reliability ranged from 0.676 to 0.844. The clinical validity was α = 0.70; confidence limits: 0.64 - 0.75, corresponding to substantial agreement. CONCLUSION: The Modena bleeding score is an effective method to score bleeding during endoscopic sinus surgery. Its application in future research could facilitate the performance and efficacy assessment of surgical techniques, materials or devices aimed to bleeding control during endoscopic sinus surgery.

Rating surgical field quality in endoscopic ear surgery: proposal and validation of the "Modena Bleeding Score".

PURPOSE: To develop and validate a bleeding score that could be applied in endoscopic ear surgery (EEarS). METHODS: A prospective validation study was performed. A new bleeding score, called "Modena Bleeding Score" (MBS), was created by the authors. It provides five grades for rating the surgical field during EEarS procedures (from grade 1-no bleeding to grade 5-bleeding that prevents every surgical procedure except those dedicated to bleeding control). A preliminary "face validity" was performed by 18 ENT specialists to assess possible misunderstandings in interpreting the scale. Then, 15 videos of endoscopic ear surgery procedures, each divided into three parts (t0, t1, and t2), were subsequently evaluated by 15 specialists, using MBS. The videos were randomly selected and assigned. Intra-rater reliability and inter-rater reliability were calculated. The clinical validity of the instrument was calculated using a referent standard (i.e., four ENT experts whose ratings were compared to those obtained by the former sample). RESULTS: The face validity showed a good consensus about the clarity and comprehension of the scale; both intra and inter-rater reliability demonstrated good performance (intra-rater reliability ranged from 0.741 to 0.991 and inter-rater reliability was 0.790); clinical validity also showed positive values, ranging from 0.75 to 0.93. CONCLUSIONS: MBS has proved to be an effective method to rate surgical field during EEarS, with good-to-excellent performances. Its use would possibly help comparisons of groups in clinical trials or comparisons between studies.