Introduction: The growing prevalence of breast implant surgery for both aesthetic and reconstructive purposes, coupled with the imperative for robust, evidence-based assessments, underscores the critical need for a standardized data collection system to capture high-quality data in the field of breast prosthetics. Consequently, the primary objective of this study was to develop a minimum data set (MDS) for a breast prosthesis registry in Iran.
Methods: This applied study was conducted in 2023. In the initial stage, a descriptive analysis was performed on medical records from Amir al-Momenin and Shahid Faqihi educational hospitals in Shiraz to identify existing breast prosthesis data elements. Subsequently, a descriptive-comparative analysis was employed to compare the required data elements in national registries of selected countries (the Netherlands, England, the United States, Korea, Sweden, and Australia). In the third stage, a Delphi questionnaire was designed and distributed to 20 plastic and cosmetic surgery specialists for validation, with 16 responding. Through two rounds of Delphi consensus, items achieving a collective agreement score above 75% were included in the final minimum data set for the breast prosthesis registry. Data analysis was performed using descriptive statistics with SPSS version 20.
Results: Of the 79 data elements proposed for expert consensus, 53 achieved agreement. These elements were categorized into eight subsets: patient demographics (10 elements), socioeconomic information (2 elements), physician and medical characteristics (6 elements), diagnosis information and clinical history (16 elements), prosthesis characteristics (5 elements), surgical procedures (9 elements), potential complications (2 elements), and follow-up (3 elements).
Discussion: It is anticipated that the proposed minimum data set will significantly contribute to information integration, enhanced quality of care, and improved safety for breast prosthesis recipients. Consequently, the inclusion of a minimum data set within the breast prosthesis registry is crucial for the collection of standardized data and the facilitation of data sharing.