NCT01725581

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 3, 2014

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

November 7, 2012

Last Update Submit

April 2, 2014

Conditions

Keywords

OSATPelvic ExaminationValidationReliability

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Factors other than the stage in training that may influence proficiency in pelvic examination

    Day 1

Study Arms (3)

Inexperienced students

Final year medical students at the end of the Obstetrics and Gynaecology placement

Procedure: Observed Structured Assessment Tool in Pelvic Examination

Experienced students

Final year medical students at the end of the Obstetrics and Gynaecology placement

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

Procedure: Observed Structured Assessment Tool in Pelvic Examination

Interventions

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 studentsInexperienced studentsJunior Doctors

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Womens Hospital

Birmingham, West Midlands, B15 2TG, United Kingdom

Location

Study Officials

  • Thomas J Clark, MBChB MD

    Birmingham Women's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 14, 2012

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 3, 2014

Record last verified: 2013-06

Locations