Female Pelvic ExaminationPEATNCT01725581
A Study to Test a New Pelvic Examination Assessment Tool
An observational study of Female Pelvic Examination, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to show that a new assessment tool for pelvic examination is valid and reliable. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Female Pelvic Examination
- What is being tested?
- Observed Structured Assessment Tool in Pelvic Examination
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Sep 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Womens Hospital
Birmingham, West Midlands, B15 2TG
About this study
Official title: 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.
Read the 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.
- Conditions
- Female Pelvic Examination
- Being tested
- Observed Structured Assessment Tool in Pelvic Examination
- Keywords
- OSAT, Pelvic Examination, Validation, Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observed Structured Assessment Tool in Pelvic ExaminationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Inexperienced students | Final year medical students at the end of the Obstetrics and Gynaecology placement Receives: Procedure: Observed Structured Assessment Tool in Pelvic Examination | |
| Experienced students | Final year medical students at the end of the Obstetrics and Gynaecology placement Receives: Procedure: Observed Structured Assessment Tool in Pelvic Examination | |
| Junior Doctors | Pre Royal College of Obstetric and Gynaecology registered junior doctors with experience in Obstetrics and Gynaecology Receives: Procedure: Observed Structured Assessment Tool in Pelvic Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of assessment tool
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.
Measured: Day 1
Reliability of assessment tool
Reliability will be measured using inter-rater reliability between 3 assessors who will be blinded to the other assessors' marks.
Measured: Day 1
Secondary outcomes (1)
Factors other than the stage in training that may influence proficiency in pelvic examination
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pelvic ExaminationStudies 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thomas Justin Clark, Birmingham Women's NHS Foundation Trust
- Investigators
- Thomas J Clark, MBChB MD, Principal investigator, Birmingham Women's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725581
- Sponsor's protocol ID
- PEAT
- Acronym
- PEAT
- Status last verified
- Jun 2013
- First submitted
- 7 Nov 2012
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Test the Validity and Reliability of an Objective Structured Assessment of Technical Skills in Pelvic Examination
- ClinicalTrials.gov ID
- NCT01725581
- Acronym / sponsor ID
- PEAT / PEAT
- Conditions
- Female Pelvic Examination
- Keywords
- OSAT, Pelvic Examination, Validation, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Nov 2012 (estimated)
- 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 show that a new assessment tool for pelvic examination is valid and reliable.
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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inexperienced students | – | Procedure: Observed Structured Assessment Tool in Pelvic ExaminationFinal year medical students at the end of the Obstetrics and Gynaecology placement |
| Experienced students | – | Procedure: Observed Structured Assessment Tool in Pelvic ExaminationFinal year medical students at the end of the Obstetrics and Gynaecology placement |
| Junior Doctors | – | Procedure: Observed Structured Assessment Tool in Pelvic ExaminationPre Royal College of Obstetric and Gynaecology registered junior doctors with experience in Obstetrics and Gynaecology |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Observed Structured Assessment Tool in Pelvic ExaminationParticipants 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. | Procedure or surgery | Experienced students, Inexperienced students, Junior Doctors |
Primary outcome
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.
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.
1 secondary outcome
Factors other than the stage in training that may influence proficiency in pelvic examination
Time frame: Day 1
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 3 Apr 2014.
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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.
Thomas J Clark, MBChB MD principal investigator
Birmingham Women's NHS Foundation Trust
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 Female Pelvic Examination, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
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 4 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 3 Apr 2014. 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 United Kingdom. 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?
Validity of assessment tool (time frame: Day 1). 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 3 Apr 2014.