This study was approved by the ethical committee of University Hospital Center of São João/Faculty of Medicine of Porto (FMUP) (approval by the ethics committee on December 18, 2020). The Guideline for Good Clinical Practice of the International Conference on Harmonization and the ethical principles of the Declaration of Helsinki was followed.23 Data collected will only be used for research purposes in accordance with the Portuguese Data Protection Law (Law No. 58/2019, of August 8, 2019) and the General Data Protection Regulation. The reporting of the study will follow the consolidated criteria for reporting qualitative research (COREQ)24 and the standards for reporting qualitative research.25
All patients will be informed of the study details and will sign an informed consent and that they may withdraw at any time without having to give a reason. The principal investigator will be the only researcher to have access to these documents. After the participant signs the informed consent, the confidentiality and anonymity of the data (including during the transcription of the interviews) will be kept by assigning an alphanumeric code to each participant to protect their identity. All collected data will be kept in a secure and restricted access area at the Faculty of Medicine of University of Porto (FMUP), only accessible to the principal investigator. After the complete transcription of the interviews, the interviews recordings will be deleted. The original database will be protected by password, only known by the principal investigator. The remaining researchers will have access to a pseudoanonymized database.
The findings of this study will be disseminated to healthcare professionals and scientists in the field through publication in peer-reviewed national and international journals and conference presentations. Contacts with patient associations during conference will also be sought.
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