跳至主要内容
临床试验/NCT05233852
NCT05233852进行中(未招募)不适用

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

Universidad Miguel Hernandez de Elche1 个研究点 分布在 1 个国家目标入组 1,538 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,538
试验地点
1
主要终点
Number of severe adverse events

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Number of severe adverse events

时间窗: 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"

时间窗: From 1st January 2022 to 31 December 2022

Number of female patients who were recommended "do not do"

Number of male patients who were recommended "do not do"

时间窗: From 1st January 2022 to 31 December 2022

Number of male patients who were recommended "do not do"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Joaquín Mira

Professor

Universidad Miguel Hernandez de Elche

研究点 (1)

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