Novak, Alex https://orcid.org/0000-0002-5091-6768
Acharya, Anita
Beer, Sally
Espinosa, Alexis
Smith, Giles Bond
Saga, Cyrene
Andrews, Jane
Bailey, Adam
Soonawalla, Zahir
Bungay, Helen https://orcid.org/0000-0003-1016-3121
Pavlides, Michael https://orcid.org/0000-0001-9882-8874
Funding for this research was provided by:
Perspectum Diagnostics Ltd
Article History
Received: 20 September 2024
Accepted: 21 January 2025
First Online: 10 February 2025
Declarations
:
: The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The study protocol and design were approved by the National Health Service (NHS) Health Research Authority (IRAS ID 240894).
: All participants provided written informed consent before enrolment in the study. The consent process included a detailed explanation of the study’s purpose, procedures, potential risks and benefits, and the voluntary nature of participation. Patients were informed about the randomisation process and the two diagnostic pathways (direct MRCP and standard care). They were also made aware that their MRCP scans would be analysed using MRCP + software. Participants were assured of their right to withdraw from the study at any time without affecting their standard medical care. The study protocol, including the consent procedure, was approved by Health Research Authority (IRAS ID 240894).
: Not Applicable. This manuscript does not contain any individual person’s data in any form, including identifying images or personal or clinical details that could compromise anonymity. As such, no specific consent for publication was required from any individuals. All data presented in this study are aggregated and anonymized, ensuring the privacy and confidentiality of all participants involved in the research. We have adhered strictly to ethical guidelines and data protection regulations throughout the study and in the preparation of this manuscript.
: MP is a shareholder in Perspectum. This study was funded and sponsored by Perspectum Ltd. The funder was involved in data analysis involving the MRCP+ platform. The corresponding author had access to all study data and had final responsibility for the decision to submit for publication.
: The guarantor of the study is Prof Alex Novak; He accepts full responsibility for the finished work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
: The lead author, Prof Alex Novak, affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.