Hemorrhoidal disease is one of the most common anorectal conditions in China. However, there is currently no validated Chinese-language questionnaire that can comprehensively assess both hemorrhoid symptoms and their impact on patients' quality of life. This study aims to translate the Hemorrhoidal Disease Symptom Score (HDSS) and the Short Health Scale for Hemorrhoidal Disease (SHS-HD) into Mandarin Chinese and evaluate whether these questionnaires are reliable and appropriate for use in Chinese-speaking patients with hemorrhoids.
Adult patients diagnosed with hemorrhoidal disease will be recruited from the Department of Anorectal Surgery at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. Participants will complete the Chinese versions of the HDSS and SHS-HD questionnaires together with routine clinical assessments. Some participants will be asked to complete the questionnaires a second time approximately 14 days later to evaluate the consistency of their responses over time.
The findings of this study are expected to provide reliable and culturally appropriate Chinese-language questionnaires for evaluating hemorrhoid symptoms and the impact of the disease on patients' quality of life. These tools may support both clinical practice and future research involving Chinese-speaking patients with hemorrhoidal disease.
Diagnosed with hemorrhoidal disease according to the 2020 Chinese Guidelines for Diagnosis and Treatment of Hemorrhoids.
Aged 18 to 60 years, inclusive, regardless of sex.
Able to understand the study and willing to provide written informed consent.
Native Mandarin speaker.
Severe visual or hearing impairment, education level below primary school (illiterate or semi-literate), or cognitive/social dysfunction that prevents completion of the questionnaire assessments.
Concurrent inflammatory bowel disease or anal fistula.
Major systemic comorbidity that may interfere with study participation.
Voluntary withdrawal from the study without prior notice, or loss to follow-up.
Patients diagnosed with hemorrhoidal disease who attend the outpatient clinic or are admitted to the inpatient ward of the Department of Anorectal Surgery at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine.
Other
Prospective
HDSS and SHS-HD Questionnaires
Diagnostic testAdministration of the Chinese versions of the Hemorrhoidal Disease Symptom Score (HDSS) and Short Health Scale for Hemorrhoidal Disease (SHS-HD) questionnaires. Participants complete both questionnaires during their clinic visit. No therapeutic intervention is administered.
Structural Validity the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
The structural validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be evaluated using confirmatory factor analysis (CFA) to examine the fit of the Chinese version to the original theoretical model. Model fit will be assessed using χ²/df (\<3 good, \<5 acceptable), comparative fit index (CFI ≥0.90), Tucker-Lewis index (TLI ≥0.90), root mean square error of approximation (RMSEA ≤0.08), and standardized root mean square residual (SRMR ≤0.08). If CFA demonstrates inadequate model fit, exploratory factor analysis (EFA) will be performed using principal component analysis with varimax rotation. Criteria include Kaiser-Meyer-Olkin (KMO) measure \>0.70, Bartlett's test of sphericity p\<0.05, eigenvalues \>1, and factor loadings \>0.40.
Structural Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
The structural validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be evaluated using confirmatory factor analysis (CFA) to examine the fit of the Chinese version to the original theoretical model. Model fit will be assessed using χ²/df (\<3 good, \<5 acceptable), comparative fit index (CFI ≥0.90), Tucker-Lewis index (TLI ≥0.90), root mean square error of approximation (RMSEA ≤0.08), and standardized root mean square residual (SRMR ≤0.08). If CFA demonstrates inadequate model fit, exploratory factor analysis (EFA) will be performed using principal component analysis with varimax rotation. Criteria include Kaiser-Meyer-Olkin (KMO) measure \>0.70, Bartlett's test of sphericity p\<0.05, eigenvalues \>1, and factor loadings \>0.40.
Internal Consistency of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
The internal consistency of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be assessed using Cronbach's alpha coefficient. A Cronbach's alpha value of ≥0.70 will be considered indicative of acceptable internal consistency.
Internal Consistency of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
The internal consistency of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be assessed using Cronbach's alpha coefficient. A Cronbach's alpha value of ≥0.70 will be considered indicative of acceptable internal consistency.
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