Gender Bias in the Overuse Studies Conducting in Primary Care

Active, not recruiting

• Conditions: Severe Adverse Event

• Registration Number: NCT05233852
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief 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).

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-10
• Study Start: 2022-05-01
• Primary Completion: 2023-05-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1538

Inclusion Criteria

• Attending primary care consultation from 1 January 2017 to 31 December 2019.
• Adult

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of severe adverse events	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 severe adverse events due to ignore "do not do" recommendations
Number of female patients who were recommended "do not do"	From 1st January 2022 to 31 December 2022	Number of female patients who were recommended "do not do"
Number of male patients who were recommended "do not do"	From 1st January 2022 to 31 December 2022	Number of male patients who were recommended "do not do"

Trial Locations

Locations (1)

Miguel Hernández University; 🇪🇸 Elche, Alicante, Spain