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Article History

Received: 29 April 2025

Accepted: 29 May 2025

First Online: 11 July 2025

Declarations

:

: The authors declare no conflicts of interest related to this study.

: As this is a quality assessment evaluation, it does not require authorization from a Research Ethics Committee (REC). The Guide for Members of Research Ethics Committees, prepared by the Steering Committee on Bioethics of the Council of Europe, defines clinical audit, which is not subject to prior evaluation by a REC, as reviews carried out in healthcare to"determine whether best practices have been adopted."The publication of results obtained from reviews of the functioning of a department or clinical service is, therefore, not considered research studies subject to REC evaluation. In addition, we would like to point out that, in Galicia, the Resolution of January 15, 2020, of the Technical General Secretariat of the Ministry of Health, which publicizes Instruction 7/2019 regarding the protocol for the processing of complementary data to clinical record registries, regulates the performance of quality assessments in healthcare as activities to evaluate the care provided to patients. The main purpose of these activities is to analyze healthcare protocols to identify whether modifications or improvements are needed. The development of these quality assessments must be authorized by the head of the service or unit involved and by the manager of the healthcare institution, documents that we have attached to the submitted publication for your verification.

: This study is a quality assessment evaluation and, therefore, does not involve any intervention, experimentation, or identifiable personal data requiring informed consent. According to the Guide for Members of Research Ethics Committees of the Council of Europe, clinical audits aimed at evaluating the implementation of best practices in healthcare are not subject to REC evaluation or individual informed consent. Additionally, as per Instruction 7/2019 and the Resolution of January 15, 2020, issued by the Technical General Secretariat of the Ministry of Health in Galicia (Spain), quality assessments based on retrospective anonymized data are regulated as healthcare management activities, not biomedical research. These activities were duly authorized by the head of the clinical unit and the healthcare institution. Therefore, informed consent was not required.