150 | Chapter 6 Materials and Methods This is a multicenter study, based on the criteria for developing a PDA as set by the International Patient Decision Aids Standards (IPDAS) Collaboration13, 14, following the three development phases (see Figure 1). The scope of the PDA was determined by the research group, based on clinical experience and literature. The PDA was developed for patients with early stage OPSCC making a primary curative treatment choice between radiation therapy and transoral (robotic) surgery (TO(R)S) with or without neck dissection (ND). The purpose of the PDA was to give an overview of the disease, treatment possibilities and side effects, and improve understanding. The multicenter multidisciplinary steering group consisted out of the following disciplines: Radiation Oncology, Speech-and-Language Pathology, Head-and-Neck Oncology and Surgery, Physiotherapy and Rehabilitation. The role of this group was to review preliminary results and content, and provide guidance through all phases of the development process. Phase 1 consisted of multiple steps. Most recent trials investigating primary surgery and radiation in early stage OPSCC were reviewed and compared with counseling materials. Furthermore, semi-structured in-depth interviews with patients and physicians from six head-and-neck centers were held to evaluate patients’ decisional needs and the regular counseling process. Inclusions were stopped after reaching data saturation. All collected data was used to construct the first version of the PDA by a web designer with experience in developing decision aids. In phase 2, the comprehensibility and usability of the PDA was alpha tested. This was done through interviews with patients and physicians, and thinking-out-loud sessions whilst showing the PDA. Afterwards everyone filled in a study-specific questionnaire with 35 statements regarding evaluation of the PDAs usability, comprehensibility, content, added value, design and satisfaction. All statements were positively framed and ranged from totally disagree (1) to totally agree (5). The questionnaire was followed by three open questions for feedback regarding points that participants liked, disliked, and suggestions for improvement. Ending with a ranking of the PDA ranging from 0-10, where a score ≥5.5 was a passing grade. Phase 3, entailed a similar routine as phase 2, more focusing on the improvements and therefore feasibility. This was tested with the same method and tools as in phase 2.
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