Translation and Validation of a Chinese Version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) in Patients With Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Internal Consistency of COMPAT-SF-CV
研究概览
简要总结
The goal of this observational study is to translate, adapt, and test the reliability of a Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) for people with chronic pancreatitis.
The study will answer these questions:
- Does the Chinese COMPAT-SF work well to measure pain in people with chronic pancreatitis?
- Is the Chinese COMPAT-SF accurate and reliable over time?
Participants will:
- Complete the Chinese COMPAT-SF questionnaire two times, with a 2-week gap.
- Answer additional pain-related questions using the Brief Pain Inventory (BPI) and the Izbicki Pain Score.
- Participate in a follow-up to check if the questionnaire gives consistent results over time.
This study will help make sure that doctors in China have a useful and reliable tool to measure pain in people with chronic pancreatitis.
详细描述
This multicenter observational study aims to translate, culturally adapt, and validate the Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) for individuals with chronic pancreatitis (CP), ensuring it is a reliable and valid pain assessment tool in China.
A total of 356 participants diagnosed with CP will be recruited from Changhai Hospital (Naval Medical University) and Peking Union Medical College Hospital. The study will follow a structured translation process, including forward translation, back translation, expert panel review, and cognitive debriefing to ensure cultural and linguistic appropriateness. Participants will complete the Chinese COMPAT-SF at baseline and again after two weeks to assess test-retest reliability, alongside additional pain assessments using the Brief Pain Inventory (BPI) and Izbicki Pain Score.
Psychometric analysis will evaluate internal consistency (Cronbach's α), test-retest reliability (intraclass correlation coefficient, ICC), construct validity (confirmatory factor analysis, CFA), and criterion validity (correlation with BPI and Izbicki Pain Score). Data will be securely recorded in an electronic database with quality control measures, including predefined range checks, consistency verification, and source data validation against medical records. Standard Operating Procedures (SOPs) will guide participant recruitment, data collection, and statistical analysis, with missing data handled using multiple imputation techniques.
Statistical analyses will include descriptive statistics, Cronbach's α for internal consistency, ICC for reliability, CFA for construct validity, and Pearson correlation to assess criterion validity. This study is expected to provide a scientifically validated, culturally adapted pain assessment tool for chronic pancreatitis, improving clinical evaluation and patient care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic pancreatitis (CP) according to the Guidelines for the Diagnosis and Treatment of Chronic Pancreatitis in China (2018 edition). Diagnosis can be confirmed by: •Primary diagnostic criteria: (i) Definitive imaging findings, and (ii) Histopathological confirmation. •Secondary diagnostic criteria: (i) Recurrent upper abdominal pain, (ii) Abnormal serum amylase levels, (iii) Pancreatic exocrine insufficiency, (iv) Pancreatic endocrine insufficiency, (v) Pathogenic gene mutations, and (vi) History of heavy alcohol consumption. •Diagnosis is confirmed if at least one primary criterion or two secondary criteria are met.
- •Experience of pancreatic pain in the past 12 months
排除标准
- •Under 18 years of age.
- •No pancreatic-related pain.
- •Diagnosed with pancreatic cancer or other tumors.
- •Presence of communication or reading impairments.
- •Refusal to participate in the study.
结局指标
主要结局
Internal Consistency of COMPAT-SF-CV
时间窗: Baseline
Internal consistency will be evaluated using Cronbach's alpha for each domain and the total score of the Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF-CV).
Test-Retest Reliability of COMPAT-SF-CV
时间窗: Baseline and 2-week follow-up
Test-retest reliability will be assessed using intraclass correlation coefficient (ICC) between baseline and 2-week follow-up responses on COMPAT-SF-CV.
Construct Validity of COMPAT-SF-CV
时间窗: Baseline
Construct validity will be examined through confirmatory factor analysis (CFA) to assess the underlying factor structure of COMPAT-SF-CV.
Criterion Validity of COMPAT-SF-CV
时间窗: Baseline
Criterion validity will be assessed by calculating correlations between COMPAT-SF-CV scores and established measures of pain severity, including the Brief Pain Inventory (BPI) and Izbicki pain score.
次要结局
未报告次要终点