SPARE: A qualitative study investigating randomization barriers in a Selective Bladder Preservation trial (SBP) (ISCRCTN: 61126465)

Abstract

5077 Background: Recruitment to randomised trials is challenging, especially when treatment strategies are complex. While studies have demonstrated barriers to recruitment, few have investigated why patients accept or refuse randomisation. The SPARE feasibility study included such an investigation to highlight difficulties that might be dealt with as the study progressed and to inform procedures for a subsequent phase III trial. Methods: Patients had newly diagnosed invasive bladder cancer and were receiving neoadjuvant chemotherapy prior to invitation to a randomised trial (SPARE) that offered the possibility of radical cystectomy or SBP. Patients allocated SBP received cystectomy or radiotherapy dependent on chemotherapy response. 15 acceptors and 10 decliners to randomisation participated in the qualitative substudy. Methods included recorded transcribed interviews and a ‘framework analysis.’ Results: Both groups experienced initial confusion, ‘muddled’ communication, information overload, and lack of time leading to misunderstandings about the trial. Perceived side effects did not necessarily inform decisions. Decision to participate was seldom made unilaterally. Individual specialist input by, and continuity between, professionals and their patients, appeared to make decision making easier. Acceptors were inclined to altruism and trust in the medical profession, often agreeing to participate with minimum understanding regarding randomisation and/or equipoise and a ‘nothing to lose’ attitude as long as withdrawal from the trial was possible. Decliners tended to opt for radiotherapy, perceived as a rational choice in the context of this trial; many abhorred the thought of surgery that was perceived as undermining and a ‘treatment in reserve.’ Conclusions: Health professionals need to consider streamlining procedures and recognise patient preferences in terms of treatments offered and information received. Recognition of the complexity of communicating equipoise and randomisation may increase ‘informed consent’ levels and recruitment rates. A further qualitative substudy investigating doctor/patient consultations in real time with confidential feedback is proposed to optimise recruitment rates. No significant financial relationships to disclose.