Paramasivan, S., Huddart, R., Hall, E., Lewis, R., Birtle, A., Donovan, J. L. (2011) Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials, 12. ISSN 1745-6215

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Abstract

Background: Recruitment to randomised controlled trials (RCTs) with very different treatment arms is often difficult. The ProtecT (Prostate testing for cancer and Treatment) study successfully used qualitative research methods to improve recruitment and these methods were replicated in five other RCTs facing recruitment difficulties. A similar qualitative recruitment investigation was undertaken in the SPARE (Selective bladder Preservation Against Radical Excision) feasibility study to explore reasons for low recruitment and attempt to improve recruitment rates by implementing changes suggested by qualitative findings. Methods: In Phase I of the investigation, reasons for low levels of recruitment were explored through content analysis of RCT documents, thematic analysis of interviews with trial staff and recruiters, and conversation analysis of audio-recordings of recruitment appointments. Findings were presented to the trial management group and a plan of action was agreed. In Phase II, changes to design and conduct were implemented, with training and feedback provided for recruitment staff. Results: Five key challenges to trial recruitment were identified in Phase I: (a) Investigators and recruiters had considerable difficulty articulating the trial design in simple terms; (b) The recruitment pathway was complicated, involving staff across different specialties/centres and communication often broke down; (c) Recruiters inadvertently used 'loaded' terminology such as 'gold standard' in study information, leading to unbalanced presentation; (d) Fewer eligible patients were identified than had been anticipated; (e) Strong treatment preferences were expressed by potential participants and trial staff in some centres. In Phase II, study information (patient information sheet and flowchart) was simplified, the recruitment pathway was focused around lead recruiters, and training sessions and 'tips' were provided for recruiters. Issues of patient eligibility were insurmountable, however, and the independent Trial Steering Committee advised closure of the SPARE trial in February 2010. Conclusions: The qualitative investigation identified the key aspects of trial design and conduct that were hindering recruitment, and a plan of action that was acceptable to trial investigators and recruiters was implemented. Qualitative investigations can thus be used to elucidate challenges to recruitment in trials with very different treatment arms, but require sufficient time to be undertaken successfully.

Item Type:	Article
Authors (ICR Faculty only):	Huddart, Robert
All Authors:	Paramasivan, S., Huddart, R., Hall, E., Lewis, R., Birtle, A., Donovan, J. L.
Additional Information:	ISI Document Delivery No.: 743GA Times Cited: 0 Cited Reference Count: 25 Paramasivan, Sangeetha Huddart, Robert Hall, Emma Lewis, Rebecca Birtle, Alison Donovan, Jenny L. Institute of Cancer Research ; Cancer Research UK [CRUK/07/011, C1491/A9895]; National Cancer Research Network ; CRUK The SPARE trial was co-ordinated by the Institute of Cancer Research Clinical Trials and Statistics Unit, sponsored by the Institute of Cancer Research and funded by Cancer Research UK (CRUK/07/011, C1491/A9895). Patient recruitment was facilitated within centres by the National Institute for Health Research (NIHR) funded National Cancer Research Network. The qualitative recruitment investigation was funded by CRUK as part of the SPARE trial. Jenny Donovan is an NIHR Senior Investigator. We thank the patients, all the investigators and research support staff at the participating centres, including those who participated in this qualitative study. Dr Julia Wade and Dr Nicola Mills contributed to the training sessions. We would also like to thank the Trial Management Group, Independent Data Monitoring and Trial Steering Committees for their oversight of the SPARE Biomed central ltd London
Uncontrolled Keywords:	surgical innovation informed-consent clinical-trials participation barriers cancer equipoise rct
Research teams:	ICR divisions > Radiotherapy and Imaging > Clinical Academic Radiotherapy (Huddart)
Depositing User:	Barry Jenkins
Date Deposited:	19 Apr 2011 12:57
Last Modified:	10 Aug 2011 13:59
URI:	http://publications.icr.ac.uk/id/eprint/10651

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