A Study to Test a New Pelvic Examination Assessment Tool

Female Pelvic Examination Clinical Trial

— PEAT  

Official title:

A Study to Test the Validity and Reliability of an Objective Structured Assessment of Technical Skills in Pelvic Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725581
• Other study ID #: PEAT
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: April 2, 2014
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: Birmingham Women's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to show that a new assessment tool for pelvic examination is valid and reliable.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Female Pelvic Examination

Intervention

Procedure:
• Observed Structured Assessment Tool in Pelvic Examination
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.

Locations

Country	Name	City	State
United Kingdom	Birmingham Womens Hospital	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Birmingham Women's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1	No
Primary	Reliability of assessment tool	Reliability will be measured using inter-rater reliability between 3 assessors who will be blinded to the other assessors' marks.	Day 1	No
Secondary	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.	Day 1	No