Clinical trial NCT04755049: The Chinese Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form Questionnaire, Patient Self-report Section: A Cross-cultural Adaptation and Validation Study
Official title: The Chinese Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form Questionnaire, Patient Self-report Section: A Cross-cultural Adaptation and Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with any shoulder disorders

Brief summary: Background: The patient self-report section of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp) is one of the most validated and reliable assessment tools. This study aimed to establish a validated Chinese version of ASESp (ASESp-CH).

Methods: A clinical prospective study was performed. Following the guidelines of forward-backward translation and cross-cultural adaptation, a Chinese version of ASESp was established. Patients older than 18 years with shoulder disorders were included. Patients who could not complete test-retest questionnaires within the interval of 7-30 days and patients who received interventions were excluded. Intraclass correlation (ICC) was calculated for test- retest reliability, whereas internal consistency was determined by Cronbach value. Construct validity was evaluated by comparing the corresponding domains between the ASESp-CH and a validated Chinese version of 36-Item Short Form Health Survey (SF-36).


Eligibility criteria: Inclusion Criteria:

* \[1\] patients' age ≥ 18 years
* \[2\] patients with clear insights
* \[3\] patients with any shoulder disorders
* \[4\] patients who are able to speak and write in Chinese
* \[5\] patients who completed the questionnaires twice at an interval of 7 days to 30 days.

Exclusion Criteria:

* \[1\] the patient could not complete all of ASESp-CH and SF-36 questionnaires
* \[2\] the test-retest interval was less than 7 days or more than 30 days
* \[3\] the patient received interventional procedures, such as shoulder injections or surgery, during the test-retest interval

Primary outcomes:
measure: The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire
timeFrame: The questionaire was completed at 7 days before the index surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
citation: Tie TA, Hong CK, Chua I, Kuan FC, Su WR, Hsu KL. The Chinese version of the American shoulder and elbow surgeons standardized shoulder assessment form questionnaire, patient self-report section: a cross-cultural adaptation and validation study. BMC Musculoskelet Disord. 2021 Apr 24;22(1):382. doi: 10.1186/s12891-021-04255-z.