Background:In the United Kingdom, totally implantable venous access systems (TIVAS) are not routinely used. Compared with Hickman catheters, these devices are more expensive and complex to insert. However, it is unclear whether the higher costs may be offset by perceived greater health benefits. This pilot trial aimed to generate relevant data to inform the design of a larger definitive randomised controlled trial.Methods:This was a phase II prospective, randomised, open trial from two UK oncology centres. The primary end point was overall complication rate. Secondary end points included individual complication rates, time to first complication and quality of life. Analysis was by intention to treat. An economic evaluation was also carried out.Results:A total of 100 patients were randomised in a 3 : 1 ratio to receive a Hickman or a TIVAS. Overall, 54% of patients in the Hickman arm suffered one or more complications compared with 38% in the TIVAS arm (one-sided P=0.068). In the Hickman arm, 28% of the devices were removed prematurely due to a complication compared with 4% in the TIVAS arm. Quality of life based on the device-specific questionnaire was greater in the TIVAS arm for 13 of the 16 questions. The economic evaluation showed that Hickman arm was associated with greater mean cost per patient £1803 (95% CI 462, 3215), but similar quality-adjusted life years −0.01 (95% CI −0.15, 0.15) than the TIVAS arm. However, there is much uncertainty associated with the results.Conclusions:Compared with Hickman catheters, TIVAS may be the cost-effective option. A larger multicentre trial is needed to confirm these preliminary findings.

Purpose: This pre-trial qualitative research study was carried out to explore patient and clinical staff attitudes to central venous access devices (CVADs). In addition, views about participation in a randomised controlled trial (RCT) were explored with the aim of maximising recruitment to an imminent RCT of three CVADs. Methods: Three patient focus groups (each comprising three patients) and 23 interviews with clinical staff were conducted. Interviews and focus group discussions were digitally recorded, transcribed verbatim, anonymised, uploaded to the QSR NVivo10 qualitative software programme and thematically analysed. Results: Analysis of focus group interviews revealed the added challenges that a CVAD poses to patients with cancer. Four key themes emerged: continuity of daily life, pain and discomfort, stigma (a mark of disgrace associated with certain conditions) and self-preservation. The findings show the impact of a CVAD on patients' ability to manage their condition. Clinical staff interviews highlighted several potential barriers to recruitment; a lack of equipoise (genuine clinical uncertainty as to which intervention is the most beneficial), concerns about the logistics of device insertion and a perceived requirement for education and training. Conclusions: This qualitative study raises awareness of key areas of concern to patients who need a CVAD for chemotherapy delivery. It was identified that there is a need for clearer patient information around CVADs. Additionally it allows investigators to identify barriers to recruitment in a timely manner in order to minimise the potential for conflict between the roles of carer and researcher and consequently, maximise recruitment to the RCT. Keywords: Cancer, Health professionals' attitudes, Patient attitudes, Qualitative research, Randomised controlled trials, Venous access devices. BackgroundThis paper presents the results of a nested pre-trial qualitative research study carried out to inform a randomised controlled trial (RCT) of central venous access devices (CVADs). Qualitative and quantitative research are the two main research paradigms; whilst quantitative research tends to use numerical data, qualitative research uses language data either in the written or oral form (1). The value of utilising a mixture of quantitative and qualitative methods in developing and evaluating complex interventions is highlighted in recent Medical Research Council Guidance (2) and funders increasingly expect to see a qualitative research component incorporated in a study design. A nested qualitative study in a larger RCT serves to provide in-depth, explanatory

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