An observational study in Severe Adverse Event, sponsored by Universidad Miguel Hernandez de Elche. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Universidad Miguel Hernandez de Elche · Observational
The purpose of this study is to analyze whether the differences between men and women in the frequency of adverse events due to ignoring "Do not do" recommendations in primary care setting are due to biological causes or gender bias.
First, using the Delphi technique, a consensus will be reached on those "Do Not Do" recommendations that should be included in the retrospective analysis study. The selection criteria for these recommendations will be if they are considered to persist in clinical practice in primary care, their relationship with factors associated with sex and gender, and if ignoring the "Do not do" recommendation could cause a serious adverse event. Second, a retrospective cohort study will be carried out in which a random selection of medical records will be reviewed to identify the frequency of adverse events due to ignoring the "Do not do" recommendations previously selected by consensus. Investigators will review a total of 1538 medical records of patients (50% of women) who attended primary care consultation from 1st January 2022 to 31st December 2022. Data source will be the electronic record management system of the autonomous community of Valencia, named ABUCASIS. Adverse events will be identified by using an activation tool used in a previous study (SOBRINA study).
Universidad Miguel Hernandez de Elche is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults attending primary care consultation from 1 January 2017 to 31 December 2019.
Exclusion Criteria:
A drug prescription or procedure included in 'do not do' recommendations
Number of severe adverse events
Number of severe adverse events due to ignore "do not do" recommendations
Time frame: From date of prescription until the date of first documented severe adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Number of female patients who were recommended "do not do"
Number of female patients who were recommended "do not do"
Time frame: From 1st January 2022 to 31 December 2022
Number of male patients who were recommended "do not do"
Number of male patients who were recommended "do not do"
Time frame: From 1st January 2022 to 31 December 2022
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Universidad Miguel Hernandez de Elche