Validation Of The Chinese Version Of CECA10in Patients With Condyloma Acuminata

Background:Condyloma Acuminata (CA), which is also called Genital Warts or AnoGenital Warts for its high occurrence rate at the genitals, is a type of benign epithelial neoplasms caused by Human Papillomavirus (HPV) infection. It is one of the most common sexually transmitted diseases (STD), with its incidence ranking the first in the STD in the Europe and the America. In China, the incidence of CA placed third on the list of the seven reported STDs. Although CA can be effectively treated, its high post-treatment recurrence rate imposes a considerable sociopsychological burden to the patients with CA and hence impairs greatly the Quality of Life (QOL). Using the generic or specific instrument (for example, Quality of life questionnaire for patients with genital warts, CECA10) of health-related quality of life (HRQOL), the study of QOL of patients with CA indicated that the emotional and sexual impacts are the most serious problems. There is no a specific instrument of HRQOL for CA patients in China’s mainland.Objectives:(1) Translate and develop a Chinese version of the CECA10from the English Version;(2) Determine the validity and reliability of the Chinese version of CECA10in Chinese Patients with CA.Methods:After the authorization, we adopted a seven-step containing approach to translated and culture-adapted the English version of CECA10to develop a Chinese one. Then, using the Chinese version CECA10, EuroQol-5D (EQ-5D) and dermatology life quality index (DLQI), we investigated211patients with CA in the sexually transmitted diseases center of the department of dermatology of the PUMCH. The data was recorded and analyzed using the SPSS13.0. The reliability analysis included Cronbach’s a coefficient and test-retest reliability. The validity analysis included content validity, construct validity, discrimination validity and criterion-related validity. A preliminary study of the QOL in Chinese patients with CA using the EQ-5D and CECA10was conducted. Using the CECA10score as the dependent variable and the others (sex, marital status, sexual mode, history of sexual related disease, number of lesions, damage parts number, level of education, income, sexual partner of the nearly6months, age, and recurrence times) as independent variables, a multi-variant linear regression was performed to analysis the data.Results:(1) The results from30patients indicated that the Chinese version of CECA10has good test-retest reliability. The intra-class correlation coefficients (ICC) was0.98, p=0.00(the ICC of the emotional dimension was0.98,P=0.00; the ICC of the sexual dimension was0.98,.P=0.00).(2) The Chinese version of CECA10has good content validity (the item-level CVI (I-CVI)=1, scale-level CVI (S-CVI)=1).(3) The results from211patients indicated that the Chinese version of CECA10has a high inner consistency with the Cronbach’s α=0.88(the Cronbach’s a is0.84in the emotion dimension and0.83in the sexual dimension) and good construct validity (Two common factors extracted by the factor analysis can explain61.75%of the overall variation. Each item has a good (>0.4) weight in the correspondent factor.). The score of the Chinese version of CECA10and DLQI showed a median negative correlation (r=-0.50, P=0.00). The discrimination validity of CECA10is not good.(4) the standardized score of the CECA10of211patients was34.56±19.01. In the emotional dimension, the lowest score was2.11±1.13(item2:1am anxious to know whether I’m going to recover from the infection for good); In the sexual dimension, the lowest score was2.05±1.06(item8:1feel worried during the act). The score of the EQ-VAS was64.64±19.28. The significant difference (t=-11.65, P=0.00) of the score of the EQ-VAS between the patients with CA and the general population indicated the QOL of the Patients with CA was low. In the EQ-5D evaluation system, the most serious problems were anxiety and depression.(5) The results of the multi-variable stepwise regression indicated that age (t=-3.34, P=0.00), sex ((t=-3.10, P=0.00) and the number of lesions (≥11)(t=-2.30, P=0.02), number of lesions (≤10)(t=-2.14, P=0.03) were the related factors. These factors could explain14%of the total variation.Conclusions:The Chinese version of CECA10has a good reliability and validity and could be used as a tool in the evaluation of the QOL of the Chinese patients with CA. In China, the QOL of the Patients with CA was lower than the general population. Age, sex, and the number of lesions were the three related factors.