It was designed as a prospective study approved by the Peking University People’s Hospital Ethics Committee (Ethics Number: 2019PHB273-01). Patients with pelvic organ prolapse were recruited on an outpatient basis at Peking University People’s Hospital from May 2019 to January 2021. All research was performed in accordance with relevant guidelines and regulations, including the Declaration of Helsinki.
Inclusion criteria: (1) Patients diagnosed with POP-Q stage II or higher pelvic organ prolapse and aged 30-90 years; (2) Patients who report at least one symptom of abnormal defecation; (3) Willing to accept relevant questionnaire survey.
Exclusion criteria: (1) Prior surgical treatment for pelvic organ prolapse; (2) Constipation was diagnosed as “slow bowel constipation”; (3) Previous diagnosis of ulcerative colitis, Crohn’s disease, or colorectal malignancy; (4) Unable to understand or complete questionnaires; (5) Complicated with other serious somatic diseases (such as diabetes with unstable blood sugar levels, heart disease, and malignant tumors in other parts of the body).
The CSS included eight questions: frequency of bowel movements, difficulty of evacuation effort, incomplete evacuation, abdominal pain, time spent in the toilet per attempt, type of assistance, unsuccessful evacuation attempts per 24 h and duration of constipation. . Respondents rated the eight questions, and each question was scored according to the corresponding options (0-2 points for type of assistance, 0-4 points for other questions, and 30 points overall). The total score for the eight questions was the total CSS score. The higher the score on the questionnaire, the more severe the symptoms of constipation.
The Chinese version of CSS has been translated according to the “WHO-QOL Questionnaire Translation Method for Cross-Cultural Quality of Life Research”. We obtained authorization for translation authentication and correlational research of the initial CSS questionnaire from the corresponding author via e-mail. To retain as much of the original meaning as possible, the CSS translation contains two dependent forward and backward translations12. We organized a pilot study with 10 participants with POP-Q stage II or higher. The official Chinese version of the CSS questionnaire was obtained based on the modified opinions of the experts and the comments of the subjects. The Rome III Criterion for Functional Constipation is a simple and easy to use method. Researchers diagnosed whether patients met Rome III criteria for functional constipation6. Patients were surveyed with the Chinese version of the CSS questionnaire at an interval of 2 to 4 weeks before surgery by two separate investigators. The researcher of the second survey was blinded to the database of the first survey. Registration data is shown in Fig. 1 additional.
Cronbach’s α coefficient was used to assess the internal consistency of the questionnaire. Cronbach’s α coefficient > 0.7 indicates that the internal consistency of the questionnaire is good. The intraclass correlation coefficient (ICC) was used to assess the reliability of the retest of the questionnaire. ICC > 0.75 indicated good retest reliability, 0.4 ≤ ICC ≤ 0.75 was fair and ICC
Factor analysis aims to determine whether the correlation between several observed variables can be explained or summarized by a smaller number of latent variables. Unobserved variables are also called factors13. There are two main methods: exploratory factor analysis and confirmed factor analysis. Exploratory factor analysis is used to conduct a preliminary investigation of a set of observed variables and confirmed factor analysis is a method used to test whether a specified factor structure is still valid for a new set of data.
Construct validity: In the exploratory factor analysis, we used the Kaiser–Meyer–Olkin test and Bartlett’s spherical test to determine whether the scale met the conditions for factor analysis. If the KMO value > 0.6 and p 1 in order to judge whether the Chinese questionnaire had an excellent logical structure. In the confirmed factor analysis, we use CMIN/DF, RMSEA, IFI, CFI, TLI, PNFI, PCFI to assess model fit, use AVE, CR to assess convergent validity, and calculate the arithmetic square root AVE and the factor correlation coefficient. If the arithmetic square root of AVE > correlation coefficient, it means that the discriminant validity is good.
Criterion validity: As a subscale of the PFDI-20 scale for the influence of defecation symptoms on quality of life, the CRADI-8 has been verified in the Chinese population of PFD9. There is still no gold standard for assessing defecation function in POP patients. Accordingly, the recommendations of the Consensus Standards for the Selection of Health Measurement Instruments (COSMIN) were followed.14. We chose CRADI-8 as the efficacy criterion. Spearman’s correlation coefficient analysis of the CSS score and the CRADI-8 score was used to assess the validity of the criteria. If p
Floor effect and ceiling effect
The floor effect and the ceiling effect mean that if more than 15% of the respondents obtain the lowest or the highest score respectively, the floor effect and the ceiling effect are considered to exist15.
The Wilcoxon signed rank test was used to assess whether there was a significant difference in CSS score before and after surgery. P
Excel was used for data entry, and SPSS 24.0 (2016 version) and AMOS 21.0 statistical software were used for data analysis. SPSS 24.0 statistical software and GraphPad Prism 8.0.2 software were used for graphical drawing. Measurement data were expressed as mean ± standard deviation (‾x ± s) or median (25th and 75th percentiles) (M (P25, P75)) according to data distribution characteristics, while classification data was were expressed as frequency and percentage. Spearman’s correlation analysis was used to assess the correlation of measurement data between the two groups. The Mann-Whitney U test of two independent samples was used to compare independent measurement data between the two groups. P
Peking University People’s Hospital Ethics Committee approved this study. (Ethics Number: 2019PHB273-01). All research was carried out in accordance with relevant guidelines and regulations, including the Declaration of Helsinki. All subjects were adults, and they obtained informed consent in the study.