RESUMEN
BACKGROUND: Bladder cancer survivors and their caregivers face profound practical (eg, use of stoma appliances and care for urinary diversion methods) and psychosocial (eg, depression and anxiety) challenges after surgical treatment with cystectomy. OBJECTIVE: To improve the health-related quality of life and postsurgical outcomes of both bladder cancer survivors and their caregivers, the team, in collaboration with Sourcetop, Inc (software design) and Dappersmith (graphic design), developed the Cancer Resource and Information Support (CRIS) software. The purpose of this manuscript is to report on the development and usability testing of the CRIS software. METHODS: The development of the CRIS software was guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model for developing behavioral treatments for chronic diseases. The ORBIT model is unique in that it proposes a flexible and progressive process with prespecific clinically significant milestones for forward movement and returns to earlier stages for refinement, and it facilitates communication among diverse groups by using terminology from the drug development model. This paper focuses on 2 phases of the ORBIT model: phase IA: define and IB: refine. During phase IA, the study team developed solutions for the stated clinical problem-adjustment to life post cystectomy-by reviewing the literature and collecting feedback from clinicians, professional organizations, bladder cancer survivors, and their caregivers. During Phase IB, the study team focused on tailoring content in the CRIS software to the user as well as usability testing with 7 participants. RESULTS: The finished product is CRIS, a web-based software for survivors of bladder cancer and their caregivers to serve as a health management and lifestyle resource after surgery. Overarching themes from phase IA (participant feedback) included how to use new medical equipment, tips and tricks for easier living with new medical equipment, questions about health maintenance, and questions about lifestyle modifications. To accommodate our target population, we also incorporated recommendations from the Americans with Disabilities Act for website design, such as large text size, large paragraph spacing, highly contrasting text and background colors, use of headings and labels to describe the purpose of the content, portrait orientation without the need for horizontal scrolling, multiple ways to access a web page within a set of pages, ability to navigate web pages in sequential order, and in-text links that are descriptive. Usability participants evaluated CRIS very positively, indicating that it was easy to use, the functions were well-integrated, and if available, they would use CRIS frequently. CONCLUSIONS: CRIS, developed over the course of 18 months by integrating feedback from experts, literature reviews, and usability testing, is the first web-based software developed for bladder cancer survivors and their caregivers to help them adjust to life following cystectomy. The efficacy of CRIS in improving patients' and caregivers' quality of life is currently being evaluated in a randomized controlled trial.
RESUMEN
Multivariate statistical process monitoring (MSPM) is becoming increasingly utilized to further enhance process monitoring in the biopharmaceutical industry. MSPM can play a critical role when there are many measurements and these measurements are highly correlated, as is typical for many biopharmaceutical operations. Specifically, for processes such as cleaning-in-place (CIP) and steaming-in-place (SIP, also known as sterilization-in-place), control systems typically oversee the execution of the cycles, and verification of the outcome is based on offline assays. These offline assays add to delays and corrective actions may require additional setup times. Moreover, this conventional approach does not take interactive effects of process variables into account and cycle optimization opportunities as well as salient trends in the process may be missed. Therefore, more proactive and holistic online continued verification approaches are desirable. This article demonstrates the application of real-time MSPM to processes such as CIP and SIP with industrial examples. The proposed approach has significant potential for facilitating enhanced continuous verification, improved process understanding, abnormal situation detection, and predictive monitoring, as applied to CIP and SIP operations.