- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01725581
A Study to Test a New Pelvic Examination Assessment Tool (PEAT)
April 2, 2014 updated by: Thomas Justin Clark, Birmingham Women's NHS Foundation Trust
A Study to Test the Validity and Reliability of an Objective Structured Assessment of Technical Skills in Pelvic Examination
The purpose of this study is to show that a new assessment tool for pelvic examination is valid and reliable.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Physical examination of the pelvis is an important core skill that medical students need to acquire.
However, due to its intimate nature some students are graduating unable to perform competent pelvic examinations.
At present, evaluation of the medical students competence at pelvic examination is done by subjective faculty assessment.
This assessment is typically performed at the end of the teaching block and is based on the assessors' recollection of the students' performance.
This kind of assessment has been shown to have poor validity and reliability.
This is in contrast to objective structured assessments of technical skill (OSATS), which use task specific and global rating scales and have been used to evaluate a wide range of clinical and surgical skills.
However, no studies to date have evaluated an assessment tool for pelvic examination.
In this study the investigators aim to determine the validity and reliability of an OSATS for pelvic examination.
In addition, the investigators aim to identify factors that influence the scores in OSATS.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom, B15 2TG
- Birmingham Womens Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Medical students and junior doctors will be approached by the clinical sub dean for O&G at Birmingham Women's Hospital (Justin Clark - chief investigator) during the beginning of their O&G placement.
They will be made aware that outcome and assessment as part of the trial will not be incorporated into their final academic grade.
Description
Inclusion Criteria:
- Final year medical students starting their Obstetrics and Gynaecology placement
- Final year medical students finishing their Obstetrics and Gynaecology placement
- Pre Royal College of Obstetrics and Gynaecology registered junior doctors doing a Obstetrics and Gynaecology placement.
- Signed Consent Form
Exclusion Criteria:
• None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Inexperienced students
Final year medical students at the end of the Obstetrics and Gynaecology placement
|
Participants will be asked to perform a pelvic examination including a speculum and bimanual examination on a pelvic model.
They will be asked to approach the pelvic model as if it were a real patient.
|
Experienced students
Final year medical students at the end of the Obstetrics and Gynaecology placement
|
Participants will be asked to perform a pelvic examination including a speculum and bimanual examination on a pelvic model.
They will be asked to approach the pelvic model as if it were a real patient.
|
Junior Doctors
Pre Royal College of Obstetric and Gynaecology registered junior doctors with experience in Obstetrics and Gynaecology
|
Participants will be asked to perform a pelvic examination including a speculum and bimanual examination on a pelvic model.
They will be asked to approach the pelvic model as if it were a real patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validity of assessment tool
Time Frame: Day 1
|
Both validity and reliability are of equal importance so there will be two primary outcomes.
Validity will be tested using the proxy measure of construct validity.
This will be demonstrated if the results of the OSATS reflect the participant experience.
|
Day 1
|
Reliability of assessment tool
Time Frame: Day 1
|
Reliability will be measured using inter-rater reliability between 3 assessors who will be blinded to the other assessors' marks.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Factors other than the stage in training that may influence proficiency in pelvic examination
Time Frame: Day 1
|
We aim to identify other factors that may influence the participants' score in OSATS in pelvic examination.
We will identify potential areas in a questionnaire administered to participant's prior the examination.
This information will be collated before the examination in a participant information form.
Information regarding gender, age, ethnicity, confidence in examination, interest in future career in obstetrics and gynaecology will be collected as secondary outcome measures.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas J Clark, MBChB MD, Birmingham Women's NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
November 7, 2012
First Submitted That Met QC Criteria
November 13, 2012
First Posted (Estimate)
November 14, 2012
Study Record Updates
Last Update Posted (Estimate)
April 3, 2014
Last Update Submitted That Met QC Criteria
April 2, 2014
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PEAT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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