Any ConditionNCT05745688
Gender Bias and Overtreatment in Primary Care
An observational study of Any Condition, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
The purpose of this study is to analyze if there are differences between men and women in the frequency of ignoring "Do not do" recommendations in primary care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Condition
- How many people
- 1,048,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 10 May 2023
- 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 2022 to 31 December 2022
Who may be able to join
- Attending primary care consultation from 1 January 2022 to 31 December 2022.
- Adults
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Study on Gender Bias and Overtreatment in Primary Care Setting
The purpose of this study is to analyze if there are differences between men and women in the frequency of ignoring "Do not do" recommendations in primary care setting.
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 about pharmacological treatments, 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 including patients who attended primary care consultation in Alicante 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), and they will be provided by the Ambulatory Assistance Information System (SIA-GAIA). Investigators will analyze the frequency of ignoring the "Do not do" recommendations previously selected by consensus by sex and age range.
- Conditions
- Any Condition
What is being measured
The primary outcome is the main question the study is designed to answer.
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 posted27 Feb 2023
- Study start1 Apr 2023
- Primary completion1 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any ConditionStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,048,000 participants (actual)
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
- NCT05745688
- Sponsor's protocol ID
- OVERGEND Data
- Status last verified
- May 2023
- First submitted
- 16 Feb 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Gender Bias and Overtreatment in Primary Care Setting
- ClinicalTrials.gov ID
- NCT05745688
- Acronym / sponsor ID
- OVERGEND Data
- Conditions
- Any Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,048,000 participants (actual)
- 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 Apr 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 27 Feb 2023 (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 if there are differences between men and women in the frequency of ignoring "Do not do" recommendations in primary care setting.
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 about pharmacological treatments, 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 including patients who attended primary care consultation in Alicante 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), and they will be provided by the Ambulatory Assistance Information System (SIA-GAIA). Investigators will analyze the frequency of ignoring the "Do not do" recommendations previously selected by consensus by sex and age range.
Study design
- Observational model
- Case only
- 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 2022 to 31 December 2022
Key inclusion criteria (2 listed)
- Attending primary care consultation from 1 January 2022 to 31 December 2022.
- Adults
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.
Primary outcome
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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 Any Condition, 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: finished, as of the sponsor's last update on 11 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 female patients who were recommended "do not do" (time frame: From 1st January 2022 to 31 December 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.