NCT05233852

Gender Bias in the Overuse Studies Conducting in Primary Care

A Framework to Analyze Gender Bias in the Overuse Studies Conducting in Primary Care

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,538 (estimated)
• Sponsor: Universidad Miguel Hernandez de Elche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Severe Adverse Event

Interventions

Type	Name	Description
OTHER	"Do not do" recommendation	A drug prescription or procedure included in 'do not do' recommendations

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-31
• Completion: 2024-12-31
• First posted: 2022-02-10
• Last updated: 2024-05-13

Locations

1 site across 1 country: Spain