BACKGROUND: External validity is central to pragmatic trials. Recruitment of a 'representative' sample is fundamental to this. However, recruitment is a complex process, requiring, first researcher access to eligible participants. Questions have been asked about the match between study samples and real-world clinical patients and the impact this has on generalisability of findings. METHOD: Using interview and observational data from a grounded theory process evaluation of a multicentre trial, we investigated factors influencing referral. RESULTS: We found evidence of a fundamental disjunction between research and clinical practice manifested in varying 'filtering' processes. Organisational culture and the knowledge and attitudes of service providers regarding research generally and specifically in this RCT resulted in exclusion of very many potentially eligible participants. CONCLUSIONS: These findings have policy and practical implications and highlight the need for development of genuinely collaborative partnerships between the research and clinical communities. Importantly, we suggest that the CONSORT recommendations be further refined to identify the potential study population.
BACKGROUND: External validity is central to pragmatic trials. Recruitment of a 'representative' sample is fundamental to this. However, recruitment is a complex process, requiring, first researcher access to eligible participants. Questions have been asked about the match between study samples and real-world clinical patients and the impact this has on generalisability of findings. METHOD: Using interview and observational data from a grounded theory process evaluation of a multicentre trial, we investigated factors influencing referral. RESULTS: We found evidence of a fundamental disjunction between research and clinical practice manifested in varying 'filtering' processes. Organisational culture and the knowledge and attitudes of service providers regarding research generally and specifically in this RCT resulted in exclusion of very many potentially eligible participants. CONCLUSIONS: These findings have policy and practical implications and highlight the need for development of genuinely collaborative partnerships between the research and clinical communities. Importantly, we suggest that the CONSORT recommendations be further refined to identify the potential study population.
Authors: Mike J Crawford; Helen Killaspy; Eleftheria Kalaitzaki; Barbara Barrett; Sarah Byford; Sue Patterson; Tony Soteriou; Francis A O'Neill; Katie Clayton; Anna Maratos; Thomas R Barnes; David Osborn; Tony Johnson; Michael King; Peter Tyrer; Diana Waller Journal: BMC Psychiatry Date: 2010-08-27 Impact factor: 3.630
Authors: Timothy B Plante; Kelly T Gleason; Hailey N Miller; Jeanne Charleston; Kristen McArthur; Cheryl Dennison Himmelfarb; Mariana Lazo; Daniel E Ford; Edgar R Miller; Lawrence J Appel; Stephen P Juraschek Journal: Clin Trials Date: 2019-10-03 Impact factor: 2.486
Authors: Dan Robotham; Simon Riches; Iain Perdue; Felicity Callard; Thomas Craig; Diana Rose; Til Wykes Journal: BMC Health Serv Res Date: 2015-05-14 Impact factor: 2.655
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