{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T02:01:34Z","timestamp":1772244094808,"version":"3.50.1"},"reference-count":36,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["NIHR155342"],"award-info":[{"award-number":["NIHR155342"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"<ns3:p>Background Peripheral artery disease (PAD) is a common health problem. There are several technologies, medications, and interventions that aim to improve or treat PAD in people with symptomatic disease. Most of these technologies, however, have been untested in high-quality randomised studies assessing effectiveness and their interactions remain unknown. We developed a proposed design for an international randomised controlled trial assessing multiple PAD treatments. Methods Over the course of 11 months (2023) several workshops and reviews of the literature took place. More specific, the proposed platform trial was designed with 44 people with PAD and 112 experts from across the world, in five work packages. The most relevant PAD treatment with unproven effectiveness were identified and key trial components as well as success criteria were defined. With input from five clinical trials units, the final format of a potential platform PAD trial in primary and secondary care was then proposed for funding. Results The proposed platform PAD randomised trial involved two major multi-arm multi-stage randomised studies, assessing PAD treatments in the community setting (1st package) and then secondary care (2nd package). The 1st package involved people with claudication and the 2nd package involves people with chronic limb threatening ischaemia (CLTI). Conclusions A platform PAD trial involves many challenges in terms of both design and delivery. The proposed design involving both people with claudication and CLTI will hopefully act as a blueprint for future work in this area.<\/ns3:p>","DOI":"10.3310\/nihropenres.13556.1","type":"journal-article","created":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T06:25:08Z","timestamp":1714371908000},"page":"24","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Designing a platform\/adaptive randomised controlled trial for peripheral arterial disease (PAD) \u2013 The PAEDIS international platform trial development project"],"prefix":"10.3310","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3399-094X","authenticated-orcid":false,"given":"Athanasios","family":"Saratzis","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"PAEDIS development award 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status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.3310\/nihropenres.14715.r32248, Mohamad A Hussain, Abena Appah-Sampong, Brigham and Women's Hospital, Massachusetts, 24 Jul 2024, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-24\/v1#referee-response-32248","order":0,"name":"referee-response-32248","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Athanasios Saratzis<\/b>; \n<i>Posted: 27 Aug 2024<\/i>; This work has developed a study design and protocol structure for a potential future platform\/adaptive randomised controlled trial relating to peripheral artery disease. It can be used as a blueprint for future trials in this area.  Exhaustive protocols for each component\/package of the proposed work cannot be published at this stage, as the final trial design has not been funded by the NIHR. As a result, we have not included the detailed design of each proposed trial component +\/- a full protocol, as this was beyond the scope of the funded developmental work. This work should act as a basis for future trial designs and is not intended to act as a finalised protocol for a study\/project.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-24\/v1#referee-comment-3352","order":1,"name":"referee-comment-3352","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14715.r32520, Eric Secemsky, Harvard Medical School, Boston, Massachusetts, 26 Aug 2024, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-24\/v1#referee-response-32520","order":2,"name":"referee-response-32520","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14715.r31723, Raul J Guzman, Yale University, New Haven, Connecticut, 11 Sep 2024, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-24\/v1#referee-response-31723","order":3,"name":"referee-response-31723","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This project is funded by the National Institute for Health and Care Research (NIHR) under its NIHR Health Technology Assessment Programme (Grant Reference Number NIHR155342). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}