Gender Bias in the Overuse Studies Conducting in Primary Care

NCT ID: NCT05233852

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1538 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-31

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).

Conditions

Severe Adverse Event

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

"Do not do" recommendation

A drug prescription or procedure included in 'do not do' recommendations

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

José Joaquín Mira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Miguel Hernández University

Elche, Alicante, Spain

Countries

Spain

References

Mira JJ, Carratala-Munuera C, Garcia-Torres D, Soriano C, Sanchez-Garcia A, Gil-Guillen VF, Vicente MA, Perez-Jover MV, Lopez-Pineda A. Low-value practices in primary care: a cross-sectional study comparing data between males and females in Spain. BMJ Open. 2024 Nov 24;14(11):e089006. doi: 10.1136/bmjopen-2024-089006.

Reference Type: DERIVED

PMID: 39581714 (View on PubMed)

Perez-Jover V, Sanchez-Garcia A, Lopez-Pineda A, Carrillo I, Mira JJ, Carratala-Munuera C. Identification of low-value practices susceptible to gender bias in primary care setting. BMC Prim Care. 2024 Jun 8;25(1):205. doi: 10.1186/s12875-024-02456-8.

Reference Type: DERIVED

PMID: 38851666 (View on PubMed)

Carrillo I, Lopez-Pineda A, Perez-Jover V, Guilabert M, Vicente MA, Fernandez C, Gil-Guillen VF, Orozco-Bletran D, Chilet-Rosell E, Luzon Oliver L, Astier-Pena MP, Tella S, Carratala-Munuera C, Mira JJ. Epidemiological study on gender bias and low-value practices in primary care: a study protocol. BMJ Open. 2023 May 9;13(5):e070311. doi: 10.1136/bmjopen-2022-070311.

Reference Type: DERIVED

PMID: 37160394 (View on PubMed)

Other Identifiers

PROMETEO/2021/061

Identifier Type: -

Identifier Source: org_study_id