Entrustable Professional Activities and Mini-Clinical Evaluation Exercise in a Simulated Workplace-based Assessment for Physical Occupational Therapist Intern
Conditions: Entrustable Professional Activities, Mini-clinical Evaluation Exercise, Physical Occupational Therapy, Occupational Therapy Education
Sponsor: Far Eastern Memorial Hospital

 
 
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Official Title of Study:   
Exploring the Relationship Between Mini-Clinical Evaluation Exercise (Mini-CEX) and 
Entrustable Professional Activities (EPAs) in Occupational Therapy Clinical Interns' 
Independent Competence 
 
NCT Number:   
Pending 
 
Date of Document:   
2025-03-10 
 
Document Type:   
Study Protocol and Statistical Analysis Plan 
 
Principal Investigator:   
Chao-Yi Cheng 
 
Institution:   
Occupational Therapy Department, Rehabilitation Department, Far Eastern Memorial 
Hospital 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Far Eastern Memorial Hospital 
Human Research/Clinical Trial Protocol      
1、 
Project Title: 
Exploring the Relationship Between Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable 
Professional Activities (EPAs) in Occupational Therapy Clinical Interns' Independent Competence 
2、 
Principal Investigator: Chao-Yi Cheng 
3、 
Co-Investigators: 
Yun Wang, Wei-Jiun Wang, Li-Chin Chang, Yu-Ming Huang, Sheng-Yuan Tso, Yu-Lin Chen 
4、 
Background: 
Before entering clinical practice, medical graduates apply theoretical knowledge acquired during 
school combined with clinical experience from clinical instructors to enhance their professional skills. 
To comprehensively evaluate interns’ professional competence during internships, workplace 
assessment tools that directly observe the intern’s performance in specific cases and provide immediate 
feedback are commonly used (Pinilla et al., 2021). In Taiwanese occupational therapy clinical settings, 
the Mini-Clinical Evaluation Exercise (Mini-CEX) developed by the American Medical Association is 
commonly applied (Norcini et al., 2003). This tool takes about 20–30 minutes per assessment and rates 
seven core skills. However, such clinical assessment tools cannot fully determine whether interns are 
capable of independent practice. 
Competency-Based Medical Education (CBME), focused on core competencies, is the current 
trend in medical education. Entrustable Professional Activities (EPAs) describe clinical tasks that 
interns are deemed competent to perform independently by the end of each training stage (Fu et al., 
2023). EPAs, developed by Dutch medical education scholar Olle ten Cate from 2005 onwards, provide 
a curricular and assessment framework where supervision levels reflect intern competence and 
trustworthiness in clinical performance (ten Cate et al., 2015). Different medical professions in Taiwan 
have begun developing their own EPAs. For occupational therapy, under the facilitation of the 
Taiwanese Occupational Therapy Association, hospitals have started pilot EPA-based clinical 
assessments and research dissemination (Fu et al., 2023). In the field of physiological occupational 
therapy, three EPAs exist for hospital use: performing occupational therapy assessment, performing 
occupational therapy interventions, and providing health education and counseling. 
Therefore, the ultimate goal during clinical internships is for students to acquire core 
competencies and translate them into workplace competencies. To determine if occupational therapy 
interns meet these goals, we need to use both Mini-CEX and EPAs. This study aims to examine the 
impact of using these two tools clinically to assess interns’ ability to practice independently and 
whether correlations exist between subscale scores. 
5、 
Objectives: This study aims to investigate the effects of combining Mini-CEX and EPAs on evaluating 
interns’ independent practice capability and the correlations between scale sub-items. It is expected 
that students performing well on EPAs and Mini-CEX will demonstrate better clinical performance 
and operational skills during internships. We hope EPAs will provide stronger evidence of interns’ 
readiness to independently perform medical tasks. 
6、 
Methods: 
(1) 
Selection criteria and sample size: 
(a) Sample size: 50 subjects at Far Eastern Memorial Hospital; 0 at other centers 
(b) Inclusion criteria: 
(i) Occupational therapy interns in the physical domain at Far Eastern Memorial Hospital 
(ii) Provide informed consent to participate 
(c) Exclusion criteria: None 
(d) Recruitment: Interns in the physiological domain will be recruited during the 6th week of their 
internship; assessment will be conducted in the 8th week. 
(e) Study design: 
This is a cross-sectional study involving physiotherapy interns receiving clinical training. 
After obtaining consent at week 6, assessments using EPAs and Mini-CEX will be conducted 

 
 
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during the 8th week in the ward. Each assessment takes about 20 minutes. Results will be 
analyzed two weeks after submission of instructors’ internship grades. Since the occupational 
therapy department covers physiological and pediatric domains with different clinical 
instructors, pediatric instructors provide consent forms and explain the study to physiological 
interns. Participation is voluntary and will not affect internship coursework or rights. 
(f) Follow-up or rehabilitation plan: 
Subjects will follow routine clinical training; EPA and Mini-CEX are routine tests at week 8. 
No additional follow-up or rehabilitation needed. 
(g) Outcome measures and statistical analysis: 
(i) Clinical performance evaluated by Mini-CEX and EPAs      
(ii)Statistic analysis: 
    Descriptive statistics for demographics; Pearson’s correlation to explore relationships 
between variables; multiple linear regression analyses for predictors of clinical 
performance including age, gender, average self-study time, prior university experience, 
parents’ occupations, and residence. Significance set at p < 0.05. 
(h) Questionnaires and data collection: 
(i) Demographics collected by semi-structured questionnaire covering age, gender, average 
self-study time, prior university experience, parents’ occupation, and residence. 
(ii) Mini-Clinical Evaluation Exercise (Mini-CEX): 
    Developed by Norcini et al. (1995) and officially translated and authorized for use in 
Taiwan since 2004 (Chen, 2007), the Mini-CEX assesses clinical diagnostic skills of 
medical interns using structured forms and immediate feedback. The assessment covers 
seven core competencies and is scored on a scale from 1 to 9 for each item, where higher 
scores indicate better clinical performance. This tool has demonstrated good reliability 
and validity (Holmboe et al., 2003). 
(iii) Entrustable Professional Activities (EPAs): 
    Developed by Olle ten Cate starting in 2005 (ten Cate et al., 2015), EPAs evaluate 
intern competence according to supervision levels required to perform professional tasks 
safely. Scores typically range from 1 to 5, with higher values indicating greater 
independence and readiness to carry out clinical activities autonomously. In Taiwan, 
EPAs have been progressively developed for various medical specialties, including 
occupational therapy. Promoted by the Taiwanese Occupational Therapy Association, 
initial pilot studies have been reported (Fu et al., 2023). This study specifically utilizes 
EPAs related to occupational therapy assessment tasks in the physiological domain. 
(2) 
Duration and schedule: 
Five physiological interns per rotation, three rotations per year (approx. 15 participants/year), 
with enrollment and data collection planned over four years. 
(3) 
Research personnel, roles, and equipment: 
No. 
Name 
Role 
Responsibilities 
1 
Chao-Yi Cheng 
Principal 
Investigator 
Proposal submission, IRB 
application, progress monitoring 
2 
Yun Wang  
Co-Investigator 
Joint planning, writing, materials 
preparation, data collection and 
analysis 
3 
Yu-Ming Huang 
Co-Investigator 
Joint planning, writing, materials 
preparation, data collection and 
analysis 
4 
Li-Chin Chang  
Co-Investigator 
Joint planning, writing, materials 
preparation, data collection and 
analysis 
5 
Wei-Jiun Wang  
Co-Investigator 
Joint planning, writing, materials 
preparation, data collection and 

 
 
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analysis 
6 
Yu-Lin Chen  
Co-Investigator 
Joint planning, writing, materials 
preparation, data collection and 
analysis 
7 
Sheng-Yuan Tso  
Co-Investigator 
Joint planning, writing, materials 
preparation, data collection and 
analysis 
7、 
Handling of research materials: 
(1) 
Collection and management during study: 
(a) Paper records will be archived in locked cabinets accessible only to the principal investigator. 
(b) Electronic data will be encrypted and stored on Google Drive, password known only by the 
principal investigator. 
(2) 
Post-study handling and storage duration: 
(a) Paper records archived securely in locked cabinets for 7 years, access restricted to principal 
investigator only. 
(b) Electronic data stored encrypted on designated computers, de-identified by replacing names 
with study codes. Password access limited to the principal investigator; others require PI’s 
permission. Data will be securely destroyed by the principal investigator after 7 years. 
8、 
Protection of participant rights: 
(1) 
Potential physical, psychological, or social harm and remedies: 
● No risks expected as participants only need to complete questionnaires. 
(2) 
Conditions and mechanisms for suspension/termination or withdrawal: 
● Participants may withdraw at any time if concerns arise, with assurance that withdrawal will 
not affect internship rights or coursework. 
(3) 
Participant compensation: None. 
9、 
Expected outcomes: 
(1) 
This study aims to explore the combined use of Mini-CEX and EPAs for assessing interns’ 
independent functioning and correlations between subscale scores, expecting positive correlation 
between EPA/Mini-CEX performance and clinical skills. This may confirm intern competency for 
independent practice.      
(2) 
Research ownership and utilization: 
● Results belong to the Rehabilitation Department of Far Eastern Memorial Hospital. Findings 
may be used by occupational therapy clinical instructors to improve teaching effectiveness. 
10、 Funding and budget: 
● Internal research grant (Project No.: FEMH-2025-C-091) 
Item 
 Description 
Amount (NTD) 
Operational 
expenses 
Consumables, supplies, books, and miscellaneous (including 
study personnel costs, wages, labor insurances, health 
insurances, and labor pension contributions) 
135,000 
Management fee 
10% of operational expenses 
13,500 
Total  
148,500 
 
11、 Conflict of interest: 
● This study is solely an internal initiative for new domain research within the unit, with no external 
collaborations, commercial involvement, or patent issues. 
12、 References: 
Fu, C. P., Chiang, F. M., Lee, C. Y., Chi, H. Y., Wu, J. L., Lin, Y. J., Li, M. W., Chen, Y. J., Chang, W. 
Y., Chang, W. D., Huang, S. M., Liao, W. S., Yang, Y. C., Huang, C. K., Kuo, N. J., Liu, T. H., & 
Chen, Y. L. (2023). Developing the topics of entrustable professional activities in pediatric 

 
 
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occupational therapy in Taiwan: A pilot study. Taiwan Journal of Occupational Therapy, 41(2), 91–
110. https://doi.org/10.6594/tjot.202308_41(2).0001 
Norcini, J. J., Blank, L. L., Duffy, F. D., & Fortna, G. S. (2003). The mini-CEX: a method for 
assessing clinical skills. Ann Intern Med, 138(6), 476-481. https://doi.org/10.7326/0003-4819-138-6-
200303180-00012  
Pinilla, S., Kyrou, A., Klöppel, S., Strik, W., Nissen, C., & Huwendiek, S. (2021). Workplace-based 
assessments of entrustable professional activities in a psychiatry core clerkship: an observational 
study. BMC Med Educ, 21(1), 223. https://doi.org/10.1186/s12909-021-02637-4  
ten Cate, O., Chen, H. C., Hoff, R. G., Peters, H., Bok, H., & van der Schaaf, M. (2015). Curriculum 
development for the workplace using Entrustable Professional Activities (EPAs): AMEE Guide No. 
99. Medical Teacher, 37(11), 983-1002. https://doi.org/10.3109/0142159X.2015.1060308