Validation of HDSS and SHS-HD in Chinese Patients With Hemorrhoids

N/ANot Yet RecruitingNCT07713966

Shanghai University of Traditional Chinese Medicine115 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

115

Conditions

Hemorrhoids

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with hemorrhoidal disease according to the 2020 Chinese Guidelines for Diagnosis and Treatment of Hemorrhoids. 2. Aged 18 to 60 years, inclusive, regardless of sex. 3. Able to understand the study and willing to provide written informed consent. 4. Native Mandarin speaker. Exclusion Criteria: 1. 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. 2. Concurrent inflammatory bowel disease or anal fistula. 3. Major systemic comorbidity that may interfere with study participation. Dropout / Withdrawal Criteria: 1. Voluntary withdrawal from the study without prior notice, or loss to follow-up. 2. Active request to withdraw from the study, or failure to cooperate with questionnaire completion after providing informed consent.

Outcomes

Primary Outcomes

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

Test-Retest Reliability of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)

The test-retest reliability of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be evaluated using the intraclass correlation coefficient (ICC; two-way mixed-effects model, absolute agreement) between baseline and the 14-day follow-up assessment. An ICC value of ≥0.80 will be considered indicative of good temporal stability.

Time frame: Baseline and 14 days

Test-Retest Reliability of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)

The test-retest reliability of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be evaluated using the intraclass correlation coefficient (ICC; two-way mixed-effects model, absolute agreement) between baseline and the 14-day follow-up assessment. An ICC value of ≥0.80 will be considered indicative of good temporal stability.

Time frame: Baseline and 14 days

Known-Groups Validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)

Known-groups validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be evaluated by comparing patients with mild hemorrhoidal disease (Goligher grade I/II) and severe hemorrhoidal disease (Goligher grade III/IV). The HDSS total score (range: 0-20, with higher scores indicating more severe hemorrhoidal symptoms) and individual item scores will be compared between groups using an independent-samples t-test for normally distributed data or the Mann-Whitney U test for non-normally distributed data. Effect sizes (Cohen's d or rank-biserial r) will also be reported. To account for multiple comparisons across nine indicators (five HDSS items and four SHS-HD items), Bonferroni correction will be applied with an adjusted significance level of α=0.0056.

Time frame: Baseline

Known-Groups Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)

Known-groups validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be evaluated by comparing patients with mild hemorrhoidal disease (Goligher grade I/II) and severe hemorrhoidal disease (Goligher grade III/IV). The SHS-HD total score (range: 4-28, with higher scores indicating poorer hemorrhoid-related health-related quality of life) and individual dimension scores will be compared between groups using an independent-samples t-test for normally distributed data or the Mann-Whitney U test for non-normally distributed data. Effect sizes (Cohen's d or rank-biserial r) will also be reported. To account for multiple comparisons across nine indicators (five HDSS items and four SHS-HD items), Bonferroni correction will be applied with an adjusted significance level of α=0.0056.

Time frame: Baseline