NCT05233852

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

January 18, 2022

Last Update Submit

May 10, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details50% women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Hernández University

Elche, Alicante, 03202, Spain

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 10, 2022

Study Start

May 1, 2022

Primary Completion

May 31, 2023

Study Completion

December 31, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations