Search

To identify the proportion of critically ill patients able to consent to participation in a randomised controlled trial (RCT) and to assess to what extent patient consent and relative assent processes could be conducted according to ethics committee permission.Descriptive study nested in an RCT.Fifty-six UK intensive care units participating in the PAC-Man trial.First 500 patients consecutively enrolled into PAC-Man.The outcome measures were patient consent and/or relative assent. Of the 498 patients included, 13 (2.6%) provided consent before randomisation. Of the remaining 485 patients, relative assent was obtained for 394 patients (81.2%), and refused post-randomisation for 3 patients (0.6%). No relatives were available for 15 patients (3.1%), and it was unclear from documentation whether relative assent had been obtained for 73 patients (15.1%). Of the 482 patients who did not provide consent prior to randomisation, 188 (39%) survived. Of these, 175 (93.1%) gave retrospective informed consent, six (3.2%) refused, and seven (3.7%) did not regain mental competency.A very small proportion of patients were able to give consent before randomisation. Due to the high in-hospital mortality (60.6%), only around one third of the remaining patients could provide consent retrospectively. This study demonstrates difficulties experienced in obtaining consent from critically ill patients to participate in medical research and raises important issues about the ethical basis of the consent process in critical care.

The objective of this study was to conduct an economic evaluation to identify any differences in the expected costs and outcomes between patients treated with pulmonary artery catheters (PACs) and those without, in order to better inform healthcare decision makers.The evaluation was carried out alongside a clinical trial investigating the use of PACs in intensive care units (ICUs) in the UK. It was conducted from the perspective of the UK NHS, in which PACs are an established intervention. Treating patients without using a PAC was characterised as the new intervention. The primary outcome measure was QALYs. The secondary outcome measure was hospital mortality. NHS costs per patient were calculated for the financial year 2002/03. The bootstrap method was used to characterise the uncertainty of the results and to construct cost-effectiveness acceptability curves.The cost per QALY and per life gained from the withdrawal of PACs were Pounds 2892 and Pounds 21,164, respectively.The results of this study indicate that withdrawal of PACs from routine clinical use in ICUs within the NHS would be considered cost effective in the current decision-making climate.