Data management 
CRF
CRF
All data will be recorded on a study-specific case report form (CRF) that has the patient’s unique study identifier code on each page. Study investigators will enter the data from CRFs into a designed study-specific REDCap database that is log-in restricted to formally approved research team members only. Data will be entered primarily by the project’s research assistant (CF) and verified by a different study investigator (SL/DL) to mitigate any risk of data entry errors (e.g. incorrect or duplicate data).The data collected and all the research-related documents (hard copy CRF, questionnaires and electronic study key) will be stored securely in a locked office in the principal investigator’s office at the Mater Misericordiae University Hospital (MMUH). Only the principal investigator and the co-investigators can have access to these documents. The records will be kept for 5 years following study closure or until such time that study outcomes are fully disseminated. All electronic files will be encrypted and accessed via password-protected computers.The electronic REDCap database also allows for specified ranges and automatic calculations to reduce entry errors. The study REDCap database will have automatic calculations for study questionnaires and specified ranges entered for each questionnaire response to ensure accurate data entry. Data will be cleaned by investigators upon completion of data collection to ensure good quality data.