Clinical trial NCT03219606: Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Official title: Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scleroderma, Systemic
Keywords: Systemic sclerosis
Education
Modified Rodnan skin score
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is evaluating the efficacy of organized education process of the modified Rodnan Skin Score (MRSS) in the systemic sclerosis. Ten physician in South Korea will be voluntarily enrolled and receive the organized training program, which encompass the lecture and demonstration of skin scoring by expert rheumatologist. Reliability and accuracy of the skin scoring before and after the education will be compared.

Detailed description: 1. Participants Ten physicians who are voluntarily enrolled in the organized education course

2. Organized education course

1. Lecture: A expert rheumatologist (master instructor) give a lecture to explain the technique of MRSS.
2. Demonstration: Master instructor demonstrate the patient assessment without revealing his score.
3. Practical training: Participants assess the MRSS of 8 patients with systemic sclerosis. Two other expert rheumatologists

3. Protocol

1. Instructor pre-meeting: Three instructors including master instructor assess the MRSS of 8 systemic sclerosis patients. Modified Rodnan score drawn by arrangement among them is defined as standard score of each patient.
2. Pre-education scoring: Participants assess the MRSS of 8 patients before the education course.
3. Organized education course
4. Post-education scoring: Participants assess the MRSS of the same 8 patients after i) lecture and ii) demonstration of master instructor
5. written test: Participants take written examination regarding the MRSS before and after the education.

4. Outcomes

1. Inter-observer reliability of MRSS before and after the education
2. Change in difference between score measure by each participant and standard score after the educational course.
3. Change in the score of written test after the educational course.

Eligibility criteria: Inclusion Criteria:

* Physician who voluntarily enroll the educational program.

Exclusion Criteria:

* Non-physician

Primary outcomes:
measure: Change in difference between score measured by each participant and standard score after the organized education course.
timeFrame: 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
Secondary outcomes:
measure: Change in written test score of each participant after the organized education course
timeFrame: 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
measure: Change in inter-observer reliability of MRSS after the organized education course
timeFrame: 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Khanna D, Furst DE, Clements PJ, Allanore Y, Baron M, Czirjak L, Distler O, Foeldvari I, Kuwana M, Matucci-Cerinic M, Mayes M, Medsger T Jr, Merkel PA, Pope JE, Seibold JR, Steen V, Stevens W, Denton CP. Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis. J Scleroderma Relat Disord. 2017 Jan-Apr;2(1):11-18. doi: 10.5301/jsrd.5000231.
citation: Czirjak L, Nagy Z, Aringer M, Riemekasten G, Matucci-Cerinic M, Furst DE; EUSTAR. The EUSTAR model for teaching and implementing the modified Rodnan skin score in systemic sclerosis. Ann Rheum Dis. 2007 Jul;66(7):966-9. doi: 10.1136/ard.2006.066530. Epub 2007 Jan 18.