Severe Adverse EventOVERGENDNCT05233852
Gender Bias in the Overuse Studies Conducting in Primary Care
An observational study of Severe Adverse Event, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Adverse Event
- What is being tested?
- "Do not do" recommendation
- How many people
- 1,538 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults attending primary care consultation from 1 January 2017 to 31 December 2019.
Who may be able to join
- Attending primary care consultation from 1 January 2017 to 31 December 2019.
- Adult
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Framework to Analyze Gender Bias in the Overuse Studies Conducting in Primary Care
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.
Read the 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
- Being tested
- "Do not do" recommendation
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Do not do" recommendationOther
A drug prescription or procedure included in 'do not do' recommendations
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe adverse events
Number of severe adverse events due to ignore "do not do" recommendations
Measured: 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"
Measured: 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"
Measured: From 1st January 2022 to 31 December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 May 2022
- Primary completion31 May 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe Adverse EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Responsible party
- Principal investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233852
- Sponsor's protocol ID
- PROMETEO/2021/061
- Acronym
- OVERGEND
- Status last verified
- May 2024
- First submitted
- 18 Jan 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39581714Perez-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.
PubMed 38851666Carrillo 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.
PubMed 37160394
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Framework to Analyze Gender Bias in the Overuse Studies Conducting in Primary Care
- ClinicalTrials.gov ID
- NCT05233852
- Acronym / sponsor ID
- OVERGEND / PROMETEO/2021/061
- Conditions
- Severe Adverse Event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,538 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults attending primary care consultation from 1 January 2017 to 31 December 2019.
Key inclusion criteria (2 listed)
- Attending primary care consultation from 1 January 2017 to 31 December 2019.
- Adult
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Do not do" recommendationA drug prescription or procedure included in 'do not do' recommendations | Other | – |
Primary outcome
Number of severe adverse events
Time frame: 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"
Time frame: 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"
Time frame: From 1st January 2022 to 31 December 2022
Number of male patients who were recommended "do not do"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 39581714Mira 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.
- Derived from this study: PubMed 38851666Perez-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.
- Derived from this study: PubMed 37160394Carrillo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Adverse Event, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of severe adverse events (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233852, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.