http://www.dspace.cam.ac.uk:80/handle/1810/221683 Sat, 25 May 2013 15:42:18 GMT 2013-05-25T15:42:18Z http://www.dspace.cam.ac.uk:80/handle/1810/238051 Title: Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT Authors: Ziebland, Sue; Featherstone, Katie; Snowdon, Claire; Barker, Karen; Frost, Helen; Fairbank, Jeremy Abstract: Abstract Background Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed. Methods We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT) to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres. Results Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice. Conclusion The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians) may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic design is not considered a design fault. We conclude that it does matter if clinicians do not understand the rationale for the trial if, as we have shown here, their perception of the trial aims and methods adversely affects who they recruit; if their views affect what the patients are told; and if they mistakenly view the results as unscientific, unreliable and ultimately irrelevant to their practice. Description: RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are. Sat, 27 Jan 2007 00:00:00 GMT http://www.dspace.cam.ac.uk:80/handle/1810/238051 2007-01-27T00:00:00Z http://www.dspace.cam.ac.uk:80/handle/1810/237731 Title: Marketing and clinical trials: a case study Authors: Francis, David; Roberts, Ian; Elbourne, Diana; Shakur, Haleema K; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K Abstract: Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. Tue, 20 Nov 2007 00:00:00 GMT http://www.dspace.cam.ac.uk:80/handle/1810/237731 2007-11-20T00:00:00Z