Assessment of Somatic Symptom Burden

Study Overview
=================
Brief Summary
-----------------
The Patient Health Questionnaire-15 (PHQ-15) is a frequently used questionnaire to assess somatic symptom burden. The Somatic Symptom Scale China (SSS-CN) was recently developed as a comprehensive self-report instrument in assessing somatic symptom burden, but its assessment value has not yet been widely tested in a nationwide. The study aims to investigate the reliability of the SSS-CN, to validate discriminate validity and factorial validity, and to investigate its utility in patients with suspected coronary artery disease (CAD) based on multi-centers inpatients.

Detailed Description
-----------------
Somatic symptoms are prevalent in kinds of medical conditions and mental disorders. Since they are associated with decreased quality of life, increased psychological distress, and increased use of health care services, the assessment of somatic symptom burden is essential in evidence based patient care and research. The Patient Health Questionnaire-15 (PHQ-15) is a frequently used questionnaire to assess somatic symptom burden, but in which there are not any mental symptoms listed. Recently, we developed the Somatic Symptom Scale China (SSS-CN) which includes common mental symptoms and more comprehensive somatic symptoms to assess somatic symptom burden, but its assessment value has not yet been widely tested. The aim of our study is to investigate the reliability and validity of the SSS-CN compared with the PHQ-15. We also try to use the SSS-CN to investigate the prevalence of somatic symptoms in patients with suspected coronary artery disease (CAD) based on multi-centers inpatients.

Official Title
-----------------
The Validation of the Somatic Symptom Scale China (SSS-CN) for Assessing Somatic Symptom Burden and Its Utility in Patients With Suspected Coronary Artery Disease

Conditions
-----------------
Somatization Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: The general population
* Diagnostic Test: Patients with suspected CAD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People who take the physical examination in Renji Hospital. Patients with suspected CAD. Exclusion Criteria: People who have been previously confirmed serious medical conditions. People who have been previously confirmed serious mental disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The general population<br>People who take the physical examination in Renji Hospital between 18 to 80 years old without any previously confirmed serious medical conditions or mental disorders. | Diagnostic Test: The general population<br>* After recruiting participants, collecting the baseline data, the SSS-CN and PHQ-15 will be carried out. Then validating the reliability, validity of the SSS-CN will be compared with the PHQ-15.<br>* Other names: SSS-CN and PHQ-15 questionnaire;|
| The patients with suspected CAD<br>Patients with suspected CAD between 18 to 80 years old without any previously confirmed serious medical conditions or mental disorders. | Diagnostic Test: Patients with suspected CAD<br>* In patients with suspected CAD, after recruiting participants, collecting the baseline data, the SSS-CN and PHQ-15 will be carried out before undergo coronary angiography. Then the prevalence of somatic symptoms will be investigated.<br>* Other names: SSS-CN and PHQ-15 questionnaire before coronary angiography;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score of the SSS-CN in the general population | To investigate the cutoff, reliability and validity of the SSS-CN according to the score. The Somatic Symptom Scale China (SSS-CN) is developed to assess somatic symptom burden, which includes 20 items. Each item represents an organ discomfort and is rated as 1 (not at all), 2 （mild）, 3（moderate）， or 4 (severe). In determining the SSS-CN score, the total score is summarized from the 20 items, rendering ranges from 20 to 80 (higher scores represent the more severe somatic symptom burden). | Within 24 hours after collecting the scale. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with somatic burden in suspected CAD patients | To validate the utility of SSS-CN and investigate the prevalence of somatic burden in patients with suspected CAD as assessed by SSS-CN. | Within 24 hours after the coronary angiography. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Somatic symptom, SSS-CN, PHQ-15, Suspected CAD, Coronary angiography