Gender Bias in the Overuse Studies Conducting in Primary Care (OVERGEND)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Adverse Event
• Intervention / Treatment: Other: "Do not do" recommendation

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 Type: Observational
• Enrollment (Estimated): 1538

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Miguel Hernández University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults attending primary care consultation from 1 January 2017 to 31 December 2019.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of severe adverse events	Number of severe adverse events due to ignore "do not do" recommendations	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"	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"	From 1st January 2022 to 31 December 2022

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborators: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PROMETEO/2021/061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No