120 Chapter 5 Data analyses Statistical analyses of differences between the two groups will be performed using SPSS for Windows version 26 (SPSS Inc.). Data will be analysed according to the intention-to-treat protocol and any missing data will be imputed. Continuous data will be reported as mean and standard deviation for a normal distribution and as median and 95% CI for a nonnormal distribution. Whether the data follows a normal distribution will be determined by visual inspection of the histograms and by analysing the data using the Kolmogorov– Smirnov test. The analysis will be performed using linear regression. Values of p <0.05 will be considered statistically significant. Categorical data will be displayed as numbers and percentages and analysed using the chi-square test. Trial discontinuation and withdrawal The participants will be informed of their right to withdraw from the trial at any time and without any explanation. There will be no further follow-up of participants who have withdrawn, and data that have already been collected will be used. The follow-up of participants will end upon the reversal of their stoma (anastomosis of the intestine and stoma closure). After stoma closure surgery, participants will be invited to complete the questionnaires 12 months after surgery or at the end of follow-up. In the app participants will register themselves when their stomas are reversed. Participants who did not receive an ileostomy or a colostomy during surgery will be withdrawn from the study and replaced with a new participant. DISCUSSION Providing adequate stoma care enables patients to cope better with their stoma and therefore it is essential for improving their quality of life. Although the importance of stoma care has been reported, it falls short in several aspects. Innovative mobile applications have significant potential to overcome these shortcomings. To our knowledge, the Stoma APPtimize trial is the first study to evaluate a patient-centred mobile application that is truly based on patients' needs and desires. This is also the first study in which the control group used a (restricted) version of an app. Self-efficacy and patient engagement can be improved by using mobile apps.17,18 A Chinese app specifically developed for stoma patients improved patient-related outcomes, such as self-efficacy, whereas a Turkish app did not improve any outcomes.17,19 However, both apps have different functionalities and are less extensive than our app. In our opinion, the Stoma APPtimize trial is the only study that has conducted a proper process for the design and development of a stoma mobile application. Before development, we assessed the problems experienced in stoma care, in addition to patients' specific needs and desired functionalities. The target group and stakeholders were involved in the development of the app to guarantee its usability and relevance.
RkJQdWJsaXNoZXIy MTk4NDMw