COSMIN terminology and reporting guidelines were used in this cross-sectional validation study. [15]. All participants provided written informed consent and the study was approved by the Ethics Committee of Oriente Services Metropolitano. [approval on 28th May 2019], Santiago de Chile. Questionnaire results were collected on paper by her four previously trained physical therapists, and patients were asked about their preference for dosage form (self-administered or interview-assisted).
participant
The study included 106 patients diagnosed with colorectal cancer at Hospital del Salvador, a public hospital in Santiago, Chile. Patients were invited to participate in health check-ups before surgical cancer treatment or up to 10 years of survival after surgical cancer treatment. No one refused to participate. Data collection was conducted between October 2019 and May 2022, but was delayed due to the COVID-19 pandemic. Exclusion criteria were people with a stoma, cognitive impairment, illiteracy (inability to understand Spanish well), being under 18 years of age, or having neurological conditions that may interfere with bowel function.
Previous sample size calculations indicated that Del Salvador Hospital treats approximately 180 colorectal cancer patients per year and recommended a reliable sample of at least 5 patients for each item on the questionnaire. Considering that, the total sample of participants was estimated at 105 people. [16].
musical instrument
The ICIQ-B provides a comprehensive assessment of intestinal and anal incontinence symptoms (including fecal and gas incontinence) and their impact on quality of life. Each item has a frequency scale for bowel symptoms and a visual numerical scale to rate the bothersomeness of the symptoms, but the last scale is not considered in calculating the score. This instrument has 21 items divided into three areas: 1 to 21 (total of 5 items) for bowel pattern, 0 to 28 (total of 7 items) for bowel control, and 21 items for bowel symptoms related to daily life. Quality is scored from 0 to 26 (total of 5 items). In addition, there are four unscored items related to other bowel symptoms, such as the Bristol Stool Consistency Scale. The response scale for most items is never, rarely, sometimes, most of the time, and always. The English version of the questionnaire, developed in the United Kingdom, has been proven to be robust and psychometrically robust, considering content, construct, criterion validity, internal consistency, and reliability analyses. [13, 17]. The Spanish version has been shown to be adequate in terms of face validity and test-retest reliability and is available in Supplementary File 1. [14]. The complete English version is available on the ICIQ website (https://iciq.net/wp-content/uploads/2019/08/Sample-ICIQ-B.pdf).
The colorectal cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire supplement (EORTC QLQ CR29) was used. The EORTC QLQ-CR29 assesses pelvic floor symptoms but focuses more on quality of life. Each item has a scale from 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = extremely). A scoring manual is available to calculate scores for each domain. Scores vary from 0 to 100. 100 represents improved function or worsened symptoms [18]. Gastrointestinal symptoms (stool frequency, bloating, flatulence, fecal incontinence, blood or mucus in the stool, dry mouth, taste), pain (abdominal pain, buttock pain, pain during intercourse, skin sores), urinary problems (frequent urination) and incontinence, difficulty urinating), psychosocial aspects (body image, hair loss, anxiety, weight, embarrassment, sexuality, impotence), and stoma care issues. This questionnaire was chosen instead of other bowel symptom questionnaires (Wexner or FIQL) because, like the ICIQ-B, it focuses on quality of life and is more representative of colorectal cancer symptoms. it was done.
Additional sociodemographic and clinical information included age, marital status, education level, cancer type, past cancer treatment history, BMI, comorbidities (diabetes, hypertension, depression/anxiety, respiratory and Musculoskeletal problems) were obtained from clinical records.
data analysis
Data were analyzed with SPSS® version 20.0 (SPSS Inc., Chicago, IL, 2011). Descriptive statistics were used to characterize the participants. Normality of the data was checked with the Kolmogorov-Smirnov test. Imputation was not required as there was missing data only for participant characteristics.
Construct validity was first assessed by confirmatory factor analysis performed in AMOS® using maximum likelihood estimation. We tested his three domain structure of the ICIQ-B. The independent item “Other intestinal symptoms” was not considered for factor analysis. [13]. We followed the proposed criteria to assess model fit. goodness-of-fit test (p > 0.15 indicates good fit), Steiger root mean square error of approximation (RMSEA, p < 0.05 は良好な適合を示し、上限値 0.08 は良好な適合を示します)合理的な適合）、比較適合指数（CFI、良好な適合を示すために > expected to be 0.90), and non-normal fit index (NNFI, expected to be > 0.90 to indicate good fit). [19]. A hypothesis test (Mann-Whitney test) was then performed to compare bowel symptoms between groups: cancer type (colon or rectum), treatment stage (preoperative or postoperative), and gender. We hypothesized that patients with rectal cancer (compared to colon), patients evaluated preoperatively (compared to postoperative), and women (compared to men) would have more severe bowel symptoms. I did.
To estimate criterion validity, Spearman correlations were calculated between scores for each domain of the ICIQ-B and EORTC QLQ-CR29 scores. Consistency between similar items (i.e. items assessing the same symptoms) in the ICIQ-B and EORTC QLQ-CR29 was investigated, respectively: items 3a and 4a for the Stool Frequency Scale, item 7a for the Skin Pain Scale, and item 9a 10a are the Fecal Incontinence Scale, Item 11a is the Flatulence Scale, Item 19a is the Embarrassment Scale, and Item 18a is the Sexual Interest Scale.correlation coefficient < 0.49 は悪い、0.50 ≤ rho ≤ 0.74 は良好、rho > 0.75 was defined as a strong relationship.
For internal consistency, Cronbach’s alpha test was used and values higher than 0.70 were considered to indicate good internal consistency. [16]. p < 0.05 was set for all tests.