Paying clinicians to join clinical trials : a review of guidelines and interview study of trialists

Background: The motivations of clinicians to participate in clinical trials have been little studied. This project explored the potential role of payment for participation in publicly funded clinical trials in the UK. The aims were to review relevant guidelines and to collate and analyse views of clinical trialists on the role of payments and other factors that motivated clinicians to join clinical trials. Methods: Review of guidelines governing payments to clinicians for recruitment to trials. Semistructured interviews with a range of NHS clinical trial leaders, analysed using qualititative methods. Results: While UK guidelines had little to say specifically on payments linked to recruitment, all payments have become highly regulated and increasingly transparent. Interview participants believed that expenses arising from research should be covered. Payments in excess of expenses were seen as likely to increase participation but with the risk of reducing quality. Motivations such as interest in the topic, the scope for patients to benefit and intellectual curiosity were considered more important. Barriers to involvement included bureaucracy and lack of time. Discussion: Limited scope exists for paying clinicians over-and-above the cost of their time to be involved in research. Most trialists favour full payment of all expenses related to research. Conclusion: Payment of clinicians beyond expenses is perceived to be a less important motivating factor than researching important, salient questions, and facilitating research by reducing bureaucracy and delay

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.

National Coordinating Centre for Research Methodology; Medical Research Council, UK Department of Health; Chief Scientist OfficeNot peer reviewedPublisher PD

Smoking related disease risk, area deprivation and health behaviours

Acknowledgements We thank Professor Luke Vale, Dr Diane Stockton and participants at the Faculty of Public Health conference, Aviemore, Scotland, November 2011 and UK Society for Behavioural Medicine conference, Stirling, Scotland, December 2011 for helpful comments. Funding This work was supported by the Medical Research Council National Preventive Research Initiative Phase 2 [G0701874]; see http://www.npri.org.uk. The Funding Partners relevant to this award are: British Heart Foundation; Cancer Research UK; Department of Health; Diabetes UK; Economic and Social Research Council; Medical Research Council; Research and Development Office for the Northern Ireland Health and Social Services; Chief Scientist Office; Scottish Government Health Directorates; The Stroke Association; Welsh Assembly Government and World Cancer Research Fund. The Health Economics Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care DirectoratePeer reviewedPostprin

Initiating a participatory action research process in the Agincourt health and socio–demographic surveillance site

Financial disclosure Funding: The research presented in this paper is funded by a Development Grant as part of the Health Systems Research Initiative from Department for International Development (DFID)/Medical Research Council (MRC)/Wellcome Trust/Economic and Social Research Council (ESRC) (MR/N005597/1). The fieldwork was completed with the Umeå Centre for Global Health Research, with support from FORTE: Swedish Council for Health, Working Life and Welfare (grant No. 2006–1512). The School of Public Health at the University of the Witwatersrand, the South African Medical Research Council, and the Wellcome Trust, UK support the MRC/Wits Rural Public Health and Health Transitions Research Unit and Agincourt HDSS (Grants 058893/Z/99/A; 069683/Z/02/Z; 085477/Z/08/Z; 085477/B/08/Z). OW is a recipient of an MSc Chevening Scholarship, the UK government's global scholarship programme, funded by the Foreign and Commonwealth Office (FCO) and partner organizations (Chevening Ref.: NGCV–2015–1194).Peer reviewedPublisher PD

Development and evaluation of an early specialised traumatic brain injury vocational rehabilitation training package

Background: In a feasibility randomised controlled trial, training was developed to equip Occupational Therapists to deliver Early Specialised Traumatic Brain Injury Vocational Rehabilitation in the English National Health Service. Methods: The package was developed by "experts" in vocational rehabilitation and traumatic brain injury and included a manual, direct instruction by six trainers and opportunity for mentorship by four therapists. Following training, therapists were interviewed regarding the effectiveness and "ease of use" of the package. Interviews were analysed using the framework approach. Results: Five trained therapists were interviewed regarding the package. Results were organised into 6 categories: (1) motivation to participate in research; (2) impact of the learning environment; (3) changing confidence levels over time; (4) growing appreciation of complexities about the intervention; (5) acceptability of the training package; (6) lessons for future implementation. Conclusions: Therapists reported acquiring knowledge necessary to implement the intervention. Data indicates that training packages require detailed descriptions of the interventions being taught for local implementation in the NHS and for future research. Training materials are valued by therapists but require time for familiarisation and reminders from mentors help put training into practice. Therapists have concerns about implementing interventions within a research context, which researchers should address

What, who and when? Incorporating a discrete choice experiment into an economic evaluation

Acknowledgements The Medman study was funded by the Department of Health for England and Wales and managed by a collaboration of the National Pharmaceutical Association, the Royal Pharmaceutical Society of Great Britain, the Company Chemist Association and the Co-operative Pharmacy Technical Panel, led by the Pharmaceutical Services Negotiating Committee. The research in this paper was undertaken while the lead author MT was undertaking a doctoral research fellowship jointly funded by the Economic and Social Research Council (ESRC) and the Medical Research Council (MRC). The Health Economics Research Unit (HERU), University of Aberdeen is funded by the Chief Scientific Office of the Scottish Government Health and Social Care Directorate.Peer reviewedPublisher PD

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT) : protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Acknowledgements This work was supported by personal fellowship award (to KG) from the Medical Research Council’s Strategic Skills Methodology programme. The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. PW is funded by a UK Medical Research Council Hub for Trials Methodology Research Network grant G0800792. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Chief Scientist Office, MRC or the Department of Health.Peer reviewedPublisher PD

Linking people with long-term health conditions to healthy community activities: development of Patient-Led Assessment for Network Support (PLANS)

Objective To combine insights from service users with long-term conditions (LTCs) to assist the development of a community referral intervention designed to promote engagement and improve access to health-relevant resources. Background Social deprivation and reduced access to resources have been causally linked with social isolation and the ability to manage LTCs. Participation in meaningful activity has been associated with positive health benefits, and strategies to promote access to community activities have shown some potential to improve outcomes for people with LTCs. This suggests the need to develop an engagement and referral intervention in partnership with service users and community groups as part of mainstream self-care support. Method A series of focus groups and interviews with members of community groups in Greater Manchester designed as an iterative and collaborative approach to elicit the role of personal and community networks that support long-term condition management (LTCM) to develop a community referral tool. Results Participants reported a broad range of resources relevant to LTCM that often went beyond the usual concerns associated with self-care. This helped to inform a tool (PLANS) to tailor access to types of community-based resources which can support LTCM. Conclusions Understanding the everyday challenges of living with a LTC highlighted the importance of connecting and engaging with localized support for people. In response to this, we developed an intervention (PLANS) which tailors access to local resources based on personal preferences, needs and acceptability to encourage service users to engage with sustainable health choices

Developing future injury prevention research leaders - in support of 'mentoring'

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