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McCarthy, Megan ORCID: 0000-0002-1415-8461, O'Keeffe, Linda, Williamson, Paula R ORCID: 0000-0001-9802-6636, Sydes, Matthew R ORCID: 0000-0002-9323-1371, Farrin, Amanda, Lugg-Widger, Fiona ORCID: 0000-0003-0029-9703, Davies, Gwyneth ORCID: 0000-0001-7937-2728, Avery, Kerry ORCID: 0000-0001-5477-2418, Chan, An-Wen, Kwakkenbos, Linda et al (show 11 more authors) , Thombs, Brett D, Watkins, Alan ORCID: 0000-0003-3804-1943, Hemkens, Lars G, Gale, Chris ORCID: 0000-0003-4732-382X, Gale, Chris ORCID: 0000-0003-0707-876X, Zwarenstein, Merrick, Langan, Sinead M ORCID: 0000-0002-7022-7441, Thabane, Lehana, Juszczak, Edmund ORCID: 0000-0001-5500-2247, Moher, David ORCID: 0000-0003-2434-4206 and Kearney, Patricia M ORCID: 0000-0001-9599-3540 (2021) A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE). HRB open research, 4. 82-.