Tjerk Sleeswijk Visser

24 Chapter 2 The medical ethical committee of Erasmus MC University Medical Center confirmed that the Medical Research Involving Human Subjects Act (WMO) did not apply to our study (MEC-2021-0279). To identify the core outcome set for Achilles tendinopathy, we predefined 5 steps based on recommended methodology9,11: 1) a systematic review on available outcome measurement instruments, 2) an online survey (1st round Delphi) on truth and feasibility, 3) assessing methodological quality of selected instruments, 4) an online survey (2nd round Delphi) on the core outcome set, and 5) an in-person consensus meeting (3rd round Delphi). The results of the first step have been published elsewhere.5 The process of the complete study is described in detail below. Panel selection The steering committee (KS, PM and RJDV) was formed in collaboration with the initiator of the COS development in tendinopathies (BV). The steering committee performed the recruitment and selection of the broader COS-AT consensus group. There was a call for potentially eligible participants during the International Scientific Tendinopathy Symposium (ISTS) in September 2018 in Groningen, the Netherlands. Some participants were also recruited afterwards via snowball methods and contacts of the steering group. The COS-AT consensus group was important for the design process and inclusion of patients throughout the project. For the Delphi parts of the process, an expert panel was selected. In the process of panel selection, our objective was to ensure a comprehensive representation of both clinicians and researchers (professional participants) and people with lived experience of having Achilles tendinopathy (referred to as patients). To achieve this, we employed a two-pronged approach. Firstly, to recruit patients, we enlisted the assistance of the COS-AT consensus group.5 This group was tasked with identifying and engaging potential patients for participation. To promote diversity, we strived to constitute a patient panel that exhibited a representative distribution in terms of gender and country of residence. Anticipating a substantial time gap between the two rounds of the Delphi survey and as we required patients with Achilles tendinopathy to have current or recent (<3 months) symptoms of Achilles tendinopathy, the individuals recruited for round 1 differed from those in round 2. We anticipated a minimum number of ten patient participants for both surveys and one for the in-person consensus meeting. Upon expressing their interest to participate, patients were promptly provided with a detailed email outlining the entirety of the process, along with an explicit explanation of their specific role within the panel. During all rounds, patients had equal voting rights as professional participants. Secondly, in the process of the selection of professional participants, we aimed to include representatives possessing varied backgrounds (both academic and clinical) and expertise,

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