DISPARITY Study: An Observational Evaluation of Characteristics of Participants in Clinical Studies

NCT06486402 | Active Not Recruiting

• 1 other identifier: W23_111 # 23.136
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. The main outcome is Participation Prevalence Ratio (PPR), which means the representation of female/male patients in a study in relation to their representation in the disease population undergoing surgery. To achieve this, we will use the average proportion of female participants enrolled per study and, in addition, data from the CBS for population benchmarking, determining the proportions of males and females undergoing surgery (elective cardiac and non-cardiac surgery) and the proportions of these populations in an academic hospital.

Conditions

Participation Rate, Patient; Patient Participation

Outcome Measures

Primary Outcomes (1)

• Participation rate

  Number of patients participating in a clinical trial

  5 year

Interventions

participation rate OTHER

participation rate

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of various clinical trials, both falling within and outside the scope of the WMO, involving adult patients undergoing various types of medical surgeries. Importantly, only studies that did not preclude women beforehand and obtained consent before participation were included in the analysis.

You may qualify if:

• various clinical trials, both falling within and outside the scope of the Medical Research Involving Human Subjects Act
• adult patients undergoing various types of medical surgeries.

You may not qualify if:

• studies which excluded or did not equally approach women beforehand

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: July 3, 2024
• Study Start: March 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

NL (1)