Objective Structured Clinical ExaminationOSCENCT03599232
Impact of Formative OSCE on Students' Summative Clinical Performance
A study testing Formative objective structured clinical examination (OSCE) in people with Objective Structured Clinical Examination and Clinical Performance, run by Hawler Medical University at 1 site in Iraq.
Trial summary
Assessment is now seen as a learning experience. there is little literature on objective structured clinical examination role for formative assessment especially in developing world Many studies showed that formative-OSCE contributes positively to final summative examination performance though most studies address… Read more about this study
- Who is it for?
- Ages 21 to 25 years
- Conditions the study is for
- Objective Structured Clinical Examination, Clinical Performance
- What is being tested?
- Formative objective structured clinical examination (OSCE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteIraq
- Study dates
- 17 Sep 2016to 20 May 2017
- Phase
- Interventional
- 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 21 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 5th-year students of both gender
Who cannot join
- students who did not fulfill the 4th year requirements.
- absent on the day of performing formative OSCE
- did not agree to participate in formative OSCE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Formative Objective Structured Clinical Examination (OSCE) on Students' Summative Clinical Performance: A Randomized Controlled Trial
Assessment is now seen as a learning experience. there is little literature on objective structured clinical examination role for formative assessment especially in developing world Many studies showed that formative-OSCE contributes positively to final summative examination performance though most studies address this point through the students' perception toward the formative-OSCE.
Having research that evaluates the effect of formative-OSCE introduction on a subsequent summative-OSCE in randomised controlled design may be of benefit for institutions considering the establishment of their own formative-OSCEs particularly in low resource countries.
Read the detailed description
Formative assessments are systematically designed instructional interventions to assess and provide feedback on students' strengths and weaknesses in the course of teaching and learning and educational experts recommend its use in addition to summative assessment. Moreover, it is a requirement in undergraduate medical education and must be at the heart of student training not just included to satisfy accreditation requirement, yet unlike other professional training culture such as music in which feedback is expected, respected and given regularly to all learners, the investigators haven't cultivated a true feedback culture in medical education.
In a performance-based assessment, the Objective Structured Clinical Examination (OSCE) has gained importance because of its reliability and could be in a summative or formative manner to measure clinical competence. Clinical skills development requires time and practice at a rate that can accelerated by feedback to optimize experiential learning and improve future performance for which a learner should enter a reflection period during which available feedback is examined.
There are some medical schools where formative assessments are institutionalized and carried out systematically, unfortunately, this kind of assessment is not very frequent in Mediterranean countries.
Undergraduate medical education in Iraq is currently going through a transitional period. The Medical college of Hawler medical university (HMU) which provides a 6-year MBChB program, has started the process of changing its curriculum to competency-based medical education (CBME) and formative assessment is a requirement in this process. In the traditional curriculum training in pediatric is introduced in 5th year with summative assessment composed of 50% written test, 30% OSCE, 10% logbook, 10% history taking skills. Students should be competent to record case history, examine children, make a provisional diagnosis, interpret investigations and communicate with children and their families given that at the allotted time end, students present the case findings and evaluated by the faculty. However, a faculty member doesn't actively observe the students' actual performance of these skills or competencies so the purpose of formative assessment is not fully met. Use of OSCE as formative assessment can overcome this problem.
Attempts have been made in OSCE implementation for summative assessment, however, formative-OSCEs introduction and evaluation in Iraqi medical colleges is lacking. Iraqi medical schools are facing challenges in staff recruitment and adequate resource provision. The latter is one of the numerous concerns and challenges to the CBME implementation.
Many studies showed that formative-OSCE contributes positively to final summative examination performance though most studies address this point through the students' perception toward the formative-OSCE.
- Being tested
- Formative objective structured clinical examination (OSCE)
- Keywords
- formative assessment, objective structured clinical examination (OSCE), Iraq, impact, feedback
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formative objective structured clinical examination (OSCE)Other
| Study group | Role | What they receive |
|---|---|---|
| intervention( formative OSCE) | Active comparator | students attended a formative objective structured clinical examination (OSCE) on the first day of their pediatric module to assess the competencies they gained from previous modules. the formative OSCE composed of 8 stations, which were both interactive and static. The interactive stations include history taking, examination, communication (counseling about breastfeeding), and procedural skills (pediatric basic life support) while non-interactive stations include data interpretation, management (linked-station) and a video-station (emergency).
assessed at end of the module(7 weeks) through summative OSCE Receives: Other: Formative objective structured clinical examination (OSCE) |
| control | No intervention | students in this group have attended pediatric module without formative OSCE and assessed at end of the module(7 weeks) through summative OSCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance in a summative OSCE test ( OSCE scores)
The randomized groups of students with and without formative OSCE were compared on mean summative OSCE score they obtained at the end of pediatric module
Measured: after 7 weeks from formative OSCE assessment
Secondary outcomes (1)
student feedback on formative OSCE
measure students' agreement on Likert scale-based questionnaire(a scale used to represent people's attitudes to a topic.) regarding their experience in formative-OSCE (distributed to students of intervention group) the format of the scale was composed of 5 level likert items ( 5 indicating strongly agree where as 1 indicating strongly disagree)
- Strongly disagree (minimum)
- Disagree
- Neither agree nor disagree
- Agree
- Strongly agree ( maximum) the percentage of student who tick agree and strongly agree were summed to indicate student agreement on each statement in the questionnaire
Measured: after completing the summative OSCE ( 7weeks after formative OSCE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start17 Sep 2016
- Primary completion20 May 2017
- Study completion20 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective Structured Clinical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Students in the intervention group (first-arm) attended a formative-OSCE on the first day of their pediatric module to assess the competencies they gained from previous modules. The formative-OSCE design involved a blueprint development which served as a guideline for the development and face-validation of the 8 stations, which were both interactive and static. The formative-OSCE examiners consisted of 2 teaching staff and 11 postgraduate pediatric board trainees, who were trained by the researcher using role model and audiovisual aids. The formative-OSCE was carried out following the exact same process of the summative-OSCE. It composed of stations assessing same competencies with standardized mark sheets and feedback. Students received feedback on their performance in the formative-OSCE on the day the results were released on a one-to-one basis. at the end of pediatric module both groups undergo summative OSCEassessment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazdar Ezzaddin Alkhateeb, Hawler Medical University
- Investigators
- Nazdar E. Alkhateeb, Master, Principal investigator, Hawler Medical UniversityAli A. Al-Dabbagh, Professor, Study director, Hawler Medical UniversityMohammed Ibrahim, MRCPCH, Study chair, Queensland Health Service, Australia.Namir G. Al-Tawil, Professor, Study chair, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599232
- Sponsor's protocol ID
- NAlkhateeb
- Acronym
- OSCE
- Status last verified
- Jul 2018
- First submitted
- 24 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Formative Objective Structured Clinical Examination (OSCE) on Students' Summative Clinical Performance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03599232
- Acronym / sponsor ID
- OSCE / NAlkhateeb
- Keywords
- formative assessment, objective structured clinical examination (OSCE), Iraq, impact, feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 17 Sep 2016 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 20 May 2017 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
Assessment is now seen as a learning experience. there is little literature on objective structured clinical examination role for formative assessment especially in developing world Many studies showed that formative-OSCE contributes positively to final summative examination performance though most studies address this point through the students' perception toward the formative-OSCE.
Having research that evaluates the effect of formative-OSCE introduction on a subsequent summative-OSCE in randomised controlled design may be of benefit for institutions considering the establishment of their own formative-OSCEs particularly in low resource countries.
Detailed description
Formative assessments are systematically designed instructional interventions to assess and provide feedback on students' strengths and weaknesses in the course of teaching and learning and educational experts recommend its use in addition to summative assessment. Moreover, it is a requirement in undergraduate medical education and must be at the heart of student training not just included to satisfy accreditation requirement, yet unlike other professional training culture such as music in which feedback is expected, respected and given regularly to all learners, the investigators haven't cultivated a true feedback culture in medical education.
In a performance-based assessment, the Objective Structured Clinical Examination (OSCE) has gained importance because of its reliability and could be in a summative or formative manner to measure clinical competence. Clinical skills development requires time and practice at a rate that can accelerated by feedback to optimize experiential learning and improve future performance for which a learner should enter a reflection period during which available feedback is examined.
There are some medical schools where formative assessments are institutionalized and carried out systematically, unfortunately, this kind of assessment is not very frequent in Mediterranean countries.
Undergraduate medical education in Iraq is currently going through a transitional period. The Medical college of Hawler medical university (HMU) which provides a 6-year MBChB program, has started the process of changing its curriculum to competency-based medical education (CBME) and formative assessment is a requirement in this process. In the traditional curriculum training in pediatric is introduced in 5th year with summative assessment composed of 50% written test, 30% OSCE, 10% logbook, 10% history taking skills. Students should be competent to record case history, examine children, make a provisional diagnosis, interpret investigations and communicate with children and their families given that at the allotted time end, students present the case findings and evaluated by the faculty. However, a faculty member doesn't actively observe the students' actual performance of these skills or competencies so the purpose of formative assessment is not fully met. Use of OSCE as formative assessment can overcome this problem.
Attempts have been made in OSCE implementation for summative assessment, however, formative-OSCEs introduction and evaluation in Iraqi medical colleges is lacking. Iraqi medical schools are facing challenges in staff recruitment and adequate resource provision. The latter is one of the numerous concerns and challenges to the CBME implementation.
Many studies showed that formative-OSCE contributes positively to final summative examination performance though most studies address this point through the students' perception toward the formative-OSCE.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Students in the intervention group (first-arm) attended a formative-OSCE on the first day of their pediatric module to assess the competencies they gained from previous modules. The formative-OSCE design involved a blueprint development which served as a guideline for the development and face-validation of the 8 stations, which were both interactive and static. The formative-OSCE examiners consisted of 2 teaching staff and 11 postgraduate pediatric board trainees, who were trained by the researcher using role model and audiovisual aids. The formative-OSCE was carried out following the exact same process of the summative-OSCE. It composed of stations assessing same competencies with standardized mark sheets and feedback. Students received feedback on their performance in the formative-OSCE on the day the results were released on a one-to-one basis. at the end of pediatric module both groups undergo summative OSCEassessment
| Arm | Type | Receives |
|---|---|---|
| intervention( formative OSCE) | Active comparator | Other: Formative objective structured clinical examination (OSCE)students attended a formative objective structured clinical examination (OSCE) on the first day of their pediatric module to assess the competencies they gained from previous modules. the formative OSCE composed of 8 stations, which were both interactive and static. The interactive stations include history taking, examination, communication (counseling about breastfeeding), and procedural skills (pediatric basic life support) while non-interactive stations include data interpretation, management (linked-station) and a video-station (emergency). assessed at end of the module(7 weeks) through summative OSCE |
| control | No intervention | –students in this group have attended pediatric module without formative OSCE and assessed at end of the module(7 weeks) through summative OSCE |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 5th-year students of both gender
Key exclusion criteria (3 listed)
- students who did not fulfill the 4th year requirements.
- absent on the day of performing formative OSCE
- did not agree to participate in formative OSCE
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 |
|---|---|---|
| Formative objective structured clinical examination (OSCE) | Other | intervention( formative OSCE) |
Primary outcome
performance in a summative OSCE test ( OSCE scores)
Time frame: after 7 weeks from formative OSCE assessment
The randomized groups of students with and without formative OSCE were compared on mean summative OSCE score they obtained at the end of pediatric module
1 secondary outcome
student feedback on formative OSCE
Time frame: after completing the summative OSCE ( 7weeks after formative OSCE)
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 26 Jul 2018.
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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.
Nazdar E. Alkhateeb, Master principal investigator
Hawler Medical University
Ali A. Al-Dabbagh, Professor study director
Hawler Medical University
Mohammed Ibrahim, MRCPCH study chair
Queensland Health Service, Australia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formative objective structured clinical examination (OSCE) in people with Objective Structured Clinical Examination and Clinical Performance, run by Hawler Medical University at 1 site in Iraq.
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 1 inclusion and 3 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 26 Jul 2018. 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 Iraq. 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?
performance in a summative OSCE test ( OSCE scores) (time frame: after 7 weeks from formative OSCE assessment). 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 26 Jul 2018.