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Purpose – The National Institute of Health Research MHRN established the Feasibility and Support to Timely recruitment for Research (FAST-R) service in 2011, to provide rapid patient and carer feedback on research documents, prior to ethical review. The aims were to improve the feasibility of studies, to speed up regulatory processes and enhance study set up and completion. The purpose of this paper is to explore whether and how the FAST-R service benefits the review process. Design/methodology/approach – An independent evaluator analysed the comments made by FAST-R members on 85 studies over the past 3.5 years. The evaluation team reflected on the nature of these comments and the implications for future practice. Findings – The FAST-R members’ comments fell into seven categories relating to: the quality of the information, the informed consent process, care and protection of participants, practical arrangements for participants, data protection and confidentiality, recruitment and research design. Based on the evaluation team’s experience of research document review, some of these comments were similar to those made by ethics committees. In other cases, the FAST-R Panel provided a different kind of input by identifying concerns specific to service users and carers. Practical implications – Patient/carer involvement in reviewing research documents brings added benefits to existing processes because their views are informed by their knowledge and experience. They are able to question assumptions and highlight concerns that people lacking their perspective might otherwise miss. These findings suggest that patient/carer involvement should form an integral part of ethical review, and that the FAST-R model might be usefully applied to other areas of health and social care research. Originality/value – This original work adds value to the practice of patient and public involvement in research.

Background: Study feasibility and deliverability can benefit from involving patients and carers in the research process, known as patient and public involvement (PPI). There is less evidence on the experiences of patients and carers themselves and we require more information across a range of studies, health conditions and research stages. Aims: This study explored how patients and carers in eight diagnostic research specialties have been involved in research, their motivations and the impact involvement had on them. Method: 143 patients and carers across the Clinical Research Network (CRN) responded to an online semi-structured questionnaire (developed using participatory methodology). Quantitative and qualitative data were analysed. Results: A range of benefits were reported, including providing a life focus and an improved relationship with illness. Less positive experiences regarding time and money and lack of acknowledgement were also reported, along with suggestions for improvement. Conclusions: PPI confers many benefits on patients and carers which could increase PPI recruitment if made explicit. More involvement in study recruitment and dissemination would increase the effectiveness of PPI input. Involving a more varied socioeconomic demographic and at an earlier stage is vital. Financial support for lower earners and greater feedback following involvement should also be explored.

Research can improve people’s health and well-being, and its use to guide the nation’s health is written into UK NHS policy. The National Institute of Health Research supports research in the NHS through clinical research networks like the Mental Health Research Network (MHRN). The MHRN supports research working collaboratively with people using services and those providing them. It supports studies that are based within mental-health services, social-care services and within primary-care services, irrespective of methodological approach. The network helps researchers screen participants for eligibility, recruit participants, conduct assessments, collect data and liaise with clinicians to promote the value of research. The MHRN provides online resources about how to involve people using services and their families and friends in research, and on how services can support and engage with research. It also helps private companies recruit participants in the NHS.

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.

Summary Background Over the past 30 years the pulmonary artery catheter (PAC) has become a widely used haemodynamic monitoring device in the management of critically ill patients, though doubts exist about its safety. Our aim was, therefore, to ascertain whether hospital mortality is reduced in critically ill patients when they are managed with a PAC. Methods We did a randomised controlled trial to which we enrolled 1041 patients from 65 UK intensive care units. We assigned individuals to management with (n=519) or without (n=522) a PAC. The timing of insertion and subsequent clinical management were at the discretion of the treating clinician. Intensive care units decided a priori to have the option of using an alternative cardiac output-monitoring device in control patients. Findings 1014 patients were eligible for analysis. We noted no difference in hospital mortality between patients managed with or without a PAC (68% [346 of 506] vs 66% [333 of 507], p=0·39; adjusted hazard ratio 1·09, 95% CI 0·94–1·27). We noted complications associated with insertion of a PAC in 46 of 486 individuals in whom the device was placed, none of which was fatal. Interpretation Our findings indicate no clear evidence of benefit or harm by managing critically ill patients with a PAC. Efficacy studies are needed to ascertain whether management protocols involving PAC use can result in improved outcomes in specific groups if these devices are not to become a redundant technology.

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.

The introduction of Training and Enterprise Councils (TECs) represents a unique opportunity to promote the “skills revolution” initiative of the CBI (in partnership with the Government) and the broader service framework for small business organizations. Describes some preliminary research which seeks to provide an indication of the cumulative effect of national and local TEC marketing initiatives on small business firms in the Sheffield area. Takes an early look at the issue around the question of TECs′ success. Findings indicate that, although general awareness about TECs is low among small business organizations, those who have used a TEC service have experienced satisfactory and quality service encounters. However, TEC marketing campaigns have been less than totally effective, to date, and more attention needs to be paid to the issues of target market‐related needs, attitudes, and promotional strategies.