Artigo Acesso aberto Revisado por pares

The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation

2018; Elsevier BV; Volume: 106; Linguagem: Inglês

10.1016/j.jclinepi.2018.10.004

ISSN

1878-5921

Autores

Leila Rooshenas, Lauren J Scott, Jane Blazeby, Chris Rogers, Kate Tilling, Samantha Husbands, Carmel Conefrey, Nicola Mills, Robert C. Stein, Chris Metcalfe, Andrew Carr, David Beard, Tim Davis, Sangeetha Paramasivan, Marcus Jepson, Kerry Avery, Daisy Elliott, Caroline Wilson, Jenny Donovan, Chris Rogers, Robert Andrews, Jane Blazeby, James Byrne, Jenny Donovan, Jamie Kelly, Graziella Mazza, David Mahon, Hamish Noble, Barnaby C Reeves, Janice L. Thompson, Sarah Wordsworth, Richard Welbourn, David Beard, Andrew Carr, Jonathan Cook, Cushla Cooper, Benjamin Dean, Jenny Donovan, Alastair Gray, Stephen Gwilym, Andrew Judge, Naomi Merritt, Jane Moser, Jonathan Rees, Ines Rombach, Julian Savulescu, Irene Tracey, Karolina Wartolowska, Eleanor Harrison, Wei Tan, Nicola Mills, Alexia Karantana, Kirsty Sprange, Lelia Duley, Daisy Elliott, Jane Blazeby, William Hollingworth, Alan Montgomery, Tim Davis, Robert C. Stein, John M.S. Bartlett, David Cameron, Amy Campbell, Peter Canney, Jenny Donovan, Janet Dunn, Helena Earl, Mary Falzon, Adele Francis, Peter Hall, Victoria Harmer, Helen Higgins, Louise Hiller, Luke Hughes‐Davies, Claire Hulme, Iain R. Macpherson, Andreas Makris, Andrea Marshall, Christopher McCabe, Adrienne Morgan, Sarah E. Pinder, Christopher Poole, Elena Provenzano, Daniel Rea, Nigel Stallard, Kerry Avery, C P Barham, Richard Berrisford, Jane Blazeby, Jenny Donovan, Daisy Elliott, Stephen Falk, Robert Goldin, George B. Hanna, Andrew A. Hollowood, Richard Krysztopik, Chris Metcalfe, Sian Noble, Grant Sanders, Christopher G. Streets, Dan Titcomb, Tim Wheatley,

Tópico(s)

Statistical Methods in Clinical Trials

Resumo

ObjectiveTo evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements "QRI actions" to address these as recruitment proceeds.Study Design and SettingA mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) qualitative case studies, including documentary analysis and interviews with RCT investigators.ResultsFive UK-based publicly funded RCTs were included in the evaluation. All recruited to target. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI actions in RCTs 1, 3, 4, and 5. Randomization rates significantly improved after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action.ConclusionThere is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.

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