Severe Adverse Event
Conditions
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).
Interventions
OTHERDo not do recommendation
A drug prescription or procedure included in 'do not do' recommendations
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Universidad Miguel Hernandez de Elche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Attending primary care consultation from 1 January 2017 to 31 December 2019. * Adult
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | From 1st January 2022 to 31 December 2022 | Number of male patients who were recommended do not do |
Countries
Spain
Outcome results
None listed