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

M

Miguel Hernández University of Elche

Status

Active, not recruiting

Conditions

Severe Adverse Event

Treatments

Other: "Do not do" recommendation

Study type

Observational

Funder types

Other

Identifiers

NCT05233852
PROMETEO/2021/061

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,538 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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