OVERGEND: Gender Bias in the Overuse Studies Conducting in Primary Care

Sponsor

Universidad Miguel Hernandez de Elche (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05233852

Collaborator

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Other)

1,538

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Adverse Event	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 2017 to 31st December 2019. 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 Design

Study Type:

Observational

Anticipated Enrollment :

1538 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Outcome Measures

Primary Outcome Measures

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 2017 to 31 December 2019]
Number of female patients who were recommended "do not do"
Number of male patients who were recommended "do not do" [From 1st January 2017 to 31 December 2019]
Number of male patients who were recommended "do not do"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

José Joaquín Mira, Professor, Universidad Miguel Hernandez de Elche

ClinicalTrials.gov Identifier:

NCT05233852

Other Study ID Numbers:

PROMETEO/2021/061

First Posted:

Feb 10, 2022

Last Update Posted:

Feb 10, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 10, 2022