Study design and population. From March 2017 to June 2017, enterostomy patients from the Coloplast Corp (Humlebaek, Denmark) Chinese database were invited to participate in the study. The company sent a study invitation letter and a link to complete an online questionnaire and patient consent form via the Wenjuanxing platform (www.wjx.cn), 1 of the largest online survey platforms in China. The 66 000 patients in the company’s database were from 22 provinces, 4 autonomous regions of ethnic minorities, and 4 directly controlled municipalities of China. The inclusion criteria for this study stipulated participants must be ≥18 years of age, have had surgery ≥1 month prior, have at least a primary school education, and be able to communicate in Chinese. Patients were excluded if they had a urostomy, a history of psychosis, cognitive impairment, and/or participation in other research programs. Patients who failed to answer at least 2 questions, provided wrong answers (eg, provided 2 responses to 1 question), or (because completion of the survey was expected 10 take 10 to 15 minutes) completed the questionnaire within 600 seconds were excluded.
The questionnaire was designed by the present researchers and had been preliminarily tested and improved in a study (unpublished) conducted in February 2017. In the preliminary study, 77 patients with colostomies were recruited from 3 hospitals in Beijing; 74 questionnaires were completed. The questionnaire was revised according to patient suggestions. To calculate the sample size for the current study, the standard deviation of the mean adjustment score was set to 10.25 ± 2.0, with a 2-sided α of 0.05 and β of 0.1. The sample size was estimated at 554.
The demographic characteristic variables collected included age, gender, employment (yes, no), educational level (≤9 years, >9 years), marital status (married, unmarried), medical payment method (self-paying, not self-paying), living status (live alone, not live alone), and residence area (urban, rural). Stoma-related data also were collected and included date of surgery, stoma siting before surgery (yes, no), type of ostomy appliance (1- or 2-piece), history of peristomal complications (yes, no), regular defecation (ie, whether the ostomate had a relatively fixed time of defecation and defecated 1 to 3 times every day after surgery; yes, no), stoma self-care ability (completely self-care, mostly self-care, relied mostly on others, relied completely on others), communication with medical staff regarding colostomy (never, sometimes [1 to 4 times per week], frequently [≥4 times per week]), level of understanding regarding stoma knowledge and care skills (complete, partly, do not understand [ie, ostomy patients do not understand knowledge and care skills for stoma at all]), when the patient learned how to change the ostomy appliance (before discharge, 1 week after discharge, other time), and stoma leakage during past 3 months (yes, no) (see Table 1). All data in the survey platform were kept anonymous; only core researchers in the current project had access to the data.
Social Support Revalued Scale (SSRS). Social support was assessed using the SSRS, which was formulated by Xiao and Yang21 in 1986. The 10-item SSRS evaluated 3 dimensions of social support: subjective support, objective support, and support utilization. Subjective support referred to how respected, supported, and understood the individual felt in his/her social context. Objective support referred to concrete support from society, such as financial support and support from a social network or organization. Support utilization was defined as how the individual used social support. The scoring system for the 10 items on the SSRS was as follows: items 1, 3, 4, and 5 represented subjective support; item 2 represented objective support; and items 8 through 10 represented social support. For items 1–4 and 8–10, there were 4 choices yielding scores of 1, 2, 3 and 4 (higher scores indicated more social support). For item 5 (which represented subjective support), there were 4 choices: A, no; B, very little; C, generally; D, all. These choices provided scores of 1, 2, 3, and 4, respectively. For items 6 (financial support) and 7 (psychological support), no source yielded a score of 0; if several sources of support were selected from a list of possible sources, a score commensurate with the number of sources selected was earned. The total SSRS score ranged from 11 to 60 points and was classified into 3 categories: low social support (<35 points), medium social support (35 to 47 points), and high social support (>47 points). The Cronbach α of the total scale was 0.896 and Cronbach α of the 3 dimensions were 0.849, 0.825, and 0.833, respectively.22
Ostomy Adjustment Inventory (OAI). The psychosocial adjustment level to the stoma was measured using the Chinese version of the OAI, which was translated and modified from the English version of the Ostomy Adjustment Inventory-23 (OAI-23) in 2011.23 The English version of the OAI-23 includes 4 dimensions and 23 items, including acceptance (9 items), continuous worry (5 items), social intercourse (4 items), and indignation (2 items).24 In contrast, the Chinese version of the OAI comprises 3 dimensions (acceptance, continuous worry, and positive life attitude) and 20 items. Responses were provided using a 5-category Likert scale ranging from 0 to 4 points, where 0 = strongly agree and 4 = strongly disagree regarding the dimension continuous worry and where 0 = strongly diasgree and 4 = strongly agree regarding the dimensions acceptance and positive life attitude. The total OAI scores ranged from 0 to 80 points and were classified into 3 categories: low adjustment level (<40 points), medium adjustment level (40 to 60 points), and high adjustment level (>60 points). A Cronbach α of 0.886 was found for the total OAI score, and continuous worry, positive life attitude, and acceptance were 0.704, 0.885, and 0.779, respectively.23 The Cronbach’s α for 2-week test-retest reliability were 0.836, 0.807, and 0.764 for continuous worry, positive life attitude, and acceptance, respectively.23 The Cronbach α of this scale was 0.913 and the Cronbach α of the 3 dimensions were 0.891, 0.872, and 0.864, respectively, according to the results of the preliminary (unpublished) study indicating that the translated Chinese version is highly reliable.
Ethical considerations. The current study was approved by the Ethics Committee of Xuanwu Hospital Capital Medical University (Beijing, China). The objective and method of research were explained to the patients before the questionnaire was made available online, and written consent of the patient or a family member was obtained.
Data collection. The questionnaire data were collected directly into the online survey platform. Only core researchers in the current project had access to data.
Data analysis. The general demographic data and stoma-related data were statistically described using mean and standard deviation. Qualitative variables were described using frequency and percentage. Single-factor analysis was conducted to analyze the adjustment level of the classified variables. A t test and 1-way analysis of variance were applied to analyze data with normal distribution and homoscedasticity. Kruskal-Wallis H and Mann-Whitney U tests were applied for data without a normal distribution and heterogeneity of variance. Pearson correlation analysis was performed to measure correlations between ostomy adjustment level and social support. An independent t test was used to compare the mean score of the overall psychological adjustment. Stepwise multiple linear regression was applied for regression analysis to identify the factors that significantly influenced the ostomy adjustment level. The inclusion criteria was 0.05, and the removal criteria was 0.10. Two-sided P <.05 was regarded as having statistical significance. SPSS, version 22 (IBM, Armonk, NY) was used for all data analysis.