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Article History

Received: 4 May 2024

Accepted: 2 July 2024

First Online: 16 July 2024

Declarations

:

: Sudipto Mukherjee has served on an advisory board for EUSA. Sudipto Mukherjee has not received any funding for his contribution for this study but receives funding support from Velosano 2020 Impact Award for Rare Cancers and Blood Diseases (Cleveland Clinic Taussig Cancer Institute). Matthew Franklin and John Brazier received funding from Lumanity (Ex BresMed); Emily Jones and Nicola Mason received funding from EUSA Pharma. Francis Shupo and Grace Wayi-Wayi are employees of EUSA Pharma. Natasa Zibelnik was an employee of EUSA Pharma but is now employed by the Menarini Group.

: In preparing to conduct the Symptom Burden Study, a non-therapeutic, non-interventional online survey, the researchers followed advice and guidance on ethics approval from each country where it was anticipated that the participants would reside. We undertook this research following the WMA Declaration of Helsinki. All patients were recruited from the Castleman Disease Collborative Network (CDCN, based in the USA) via communication to their members, who reside all over the world. The advertisement of this survey was limited to CDCN members only, irrespective of their resident country, but the participation was limited to four English-speaking countries. These countries were Australia, Canada, the UK, and the USA given similarities in the consent and approval process, proportional representation of patients with iMCD from these countries in the CDCN, and the likelihood of recruiting an adequate number of respondents. Approval was granted by the following Ethics Committees: Advarra for Canada: Pro00049277 granted 4/04/2021; Australia: Bellberry 2021–05-507, 26/07/2021. Guided by Advarra it was concluded (and communicated to BresMed) that the study met the US criteria (at the time of submission) for exemption from ethics approval/IRB oversight. To assess the need for ethics approval in the UK, the online NHS portal assessment questions were complemented and it was determined that ethics approval was not required. Therefore waivers were obtained for England, Wales, Scotland, and Northern Ireland. Of note, there were no designated clinical sites, centres, nor investigators in any of the four countries for direct recruitment of the study patients as it was an international online survey and recruitment of all patients was done via the CDCN. Informed consent was obtained from all individual participants included in the study before they could participate in the online survey. Study participants were able to withdraw from the study at any point. Consent to publish was obtained from all individual participants included in the study.