Shannon van Hoorn

127 PROMIS in VWD, IPFDs and RBDs 5 Medical Center Rotterdam (Erasmus MC), the Netherlands. Patients from the TiN study were included if they had a confirmed IPFD as defined by the TiN study. Patients from the RBiN study were included if they received treatment at the hemophilia treatment center Nijmegen-Eindhoven-Maastricht, location Radboud university medical center (Radboud UMC), the Netherlands. Patients who met the inclusion criteria were invited to participate in this study by email between March 2023 and December 2023. This email included a brief explanation about the study goals, the participant information letter, a link to the study website (https://promis-symphony.nl/) of the KLIK PROM portal, and a personal login code 31. Participants were required to sign an online informed consent form before they could complete the PROMs. Participants were asked to complete the PROMs within two weeks of receiving the invitation email. A reminder to complete the PROMs was sent after two weeks. Additionally, participants were contacted by phone if there was no response to the initial invitation or reminder email for further clarification or if participants requested more information. For this validation study, we aimed to include at least 100 participants as recommended by the Consensus-based standards for the selection of health measurement instruments (COSMIN) guidelines 32. The Medical Research Ethical Committee of the Radboud University Medical Center (MREC Oost-Nederland) reviewed the study protocol and determined it to be exempt from the Medical Research Involving Human Subjects Act (WMO) (MEC-2022-13847). In addition, this study was included as an amendment of the original Win-Pro and TiN studies. These amendments were reviewed and approved by respectively the Medical Research Ethics Committee of the Erasmus University Medical Center Rotterdam and the Medical Research Ethics Committee of the University Medical Center Utrecht (MREC NedMec), respectively. Measures PROMIS measures In collaboration with the Dutch research group for PROMIS implementation in inherited bleeding disorders, seven Dutch PROMIS measures were selected and assessed as CAT: v2.0 physical function, v1.1 pain interference, v1.0 fatigue, v1.0 anxiety, v1.0 depression, v2.0 ability to participate in social roles and activities, and v2.0 satisfaction with social roles and activities23,26,33. In addition, we assessed the short form v1.1 anger and fixed scale v1.2 global health since there is no CAT version available for these measures. The short form anger

RkJQdWJsaXNoZXIy MTk4NDMw