Executive Summary of HTA journal title
Health Technol Assess 2008;12(10):1–128
Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study
View/Download full text in Adobe Acrobat format (580 kbytes)
View/Download this summary in Adobe Acrobat format (suitable for printing)
J Raftery,1* J Bryant,1 J Powell,2 C Kerr1 and S Hawker1
1 Wessex Institute for Health Research and Development (WIHRD), University of Southampton, UK
2 Health Sciences Research Institute, University of Warwick, Coventry, UK
* Corresponding author
Payment of healthcare professionals is one way to encourage recruitment to clinical trials. However, little is known about the effects of financial incentives for clinicians to become involved in these trials, whether as lead investigators or as collaborators.
The objectives of the systematic review were:
- to synthesise the evidence on the effectiveness of monetary incentives to healthcare professionals to recruit patients to clinical trials
- to provide an overview of the ethical issues from the published literature
- to identify current UK guidelines on financial incentives to healthcare professionals to recruit patients to trials.
The objectives of the primary research were:
- to identify the attitudes, beliefs and behaviour of healthcare professionals and the public in relation to financial incentives for recruitment to trials
- to explore how financial incentives were viewed in relation to other barriers and facilitators to healthcare professionals recruiting patients to clinical trials
- to provide an overview of the current UK practice regarding the payment of financial incentives to healthcare professionals for recruitment of patients to trials.
A systematic review of the evidence was undertaken using a priori methods, purposive review and summary of relevant literature.
Primary research in the form of qualitative interviews of three groups of people: NHS healthcare professionals, research managers from the pharmaceutical industry and members of the public.
Electronic databases were searched from inception to June 2006 to identify studies for the systematic review.
The qualitative investigation involved semi-structured interviews with purposive samples of healthcare professionals, research managers from the pharmaceutical industry and the public.
English language studies were included in the systematic review if they fulfilled the standard criteria to interventions (payments), participants (healthcare professionals) and outcome (patient recruitment). Randomised controlled trials (RCTs), cohort, cross-sectional and before/after designs were included.
From the searches, 634 identified studies were assessed for inclusion through two stages with titles and abstracts. Only three were then selected to be assessed independently by two reviewers.
Fifty-eight individuals were interviewed: 38 chief investigators, six non-research active clinicians, eight public and six pharmaceutical managers. Investigators were selected from those funded by the HTA Programme, the other by 'snowballing' and personal contact.
Data extraction and quality assessment
For the systematic review, data extraction and methodological quality assessment of the included studies were performed independently by two reviewers. Studies meeting the systematic review criteria were synthesised using a narrative approach with full tabulation of results from all included studies.
For the primary research, interviews were transcribed verbatim and entered into NVivo software for analysis and management. A hierarchical coding system was centralised around themes of 'motivation' and 'incentives' for healthcare professionals, and 'patient experiences' and 'incentives' for the public. Data are presented as representative quotations. Results were 'triangulated' between the included groups.
The evidence from the literature was limited and inconclusive. Three cross-sectional surveys examined the association of demographic characteristics and perceived motivating factors of clinicians with recruitment. One primary care study reported no relation between incentive-driven motivation and number of patients recruited; the other primary care study did not report a correlation between financial reimbursement and recruitment rates. A hospital-based study reported that payment to participating clinics was considered of minor importance for recruiting patients.
In UK guidelines, the issues around payments to clinicians or patients were implied rather than stated, usually linked to discussion of conflict of interest and disclosure of any such conflicts. Developments in NHS research governance had led to increased transparency in all payments for research participation and for payments to be to NHS Trusts rather than to individual clinicians.
Interviews with NHS health professionals, mainly clinical chief investigators, indicated concerns over the likely effects of payment. While reimbursement of costs incurred to do with research was strongly supported, payments to incentivise recruitment were not. Direct payment to clinicians was rare in publicly funded trials. A code of practice for any such payments was suggested by interviewees, closely linked to the principles of Good Clinical Practice in research. Factors such as interest in the topic, scope for patient benefit and good communication were considered more important motivations for research involvement.
Interviews with the public indicated low levels of awareness of the existence of payments to clinicians linked to patient recruitment in trials, and unanimous support for full disclosure of any such payments. Interviews with research managers in the pharmaceutical industry showed greater familiarity with payments for research involvement, which had in recent years shifted to payment to institutions rather than to individual clinicians. GPs were the only group to whom scope existed for individual payments. Concerns were expressed by the pharmaceutical company interviewees at the rising cost of research and unnecessary bureaucracy.
The ethical stances outlined in Good Clinical Practice in research were widely endorsed by the three groups. These allow reasonable payments to clinicians, subject to disclosure of any possible conflicts of interest. The potential for incentivising clinicians to recruit was limited by two main factors: first that any payments should be based on the cost of their inputs, and second that payments should not be to individuals but to their host organisation.
NHS professionals were concerned that payments could damage the quality of research. They considered full disclosure to patients as challenging. Patients and members of the public favoured full disclosure and payment of expenses to patients involved in research. Pharmaceutical company interviews showed that payment to the NHS for all research activities was normal and highly regulated. They complained that the prices charged were high and so variable that they required benchmarking. Considerable scope exists for compiling data on the factors that help and hinder the progress of clinical trials and also for experimenting with different incentives to encourage involvement in clinical research.
Further research is recommended in the following areas.
- Improved reporting of those organisational aspects of trials that are known to affect recruitment, including the type and extent of payments.
- Retrospective analysis of the factors associated with different levels of recruitment to RCTs, including payment of expenses to patients.
- Prospective comparative research on trial recruitment including between commercial and publicly funded trials within the NHS research networks and also between the roles of investigators and collaborators.
- Qualitative research on participants' experiences of being involved in different kinds of trials, and also to do with the appropriateness of the guidelines on payment for participation.
- Consideration by funders of clinical trials of proposals to include within trials experiments with payments methods, comparing different levels of disclosure and of payment.
Raftery J, Bryant J, Powell J, Kerr C, Hawker S. Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. Health Technol Assess 2008;12(10).
NIHR Health Technology Assessment Programme
The Health Technology Assessment (HTA) Programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.
The research findings from the HTA Programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'.
The HTA Programme is needs-led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects.
First is the commissioned route. Suggestions for research are actively sought from people working in the NHS, the public and consumer groups and professional bodies such as royal colleges and NHS trusts. These suggestions are carefully prioritised by panels of independent experts (including NHS service users). The HTA Programme then commissions the research by competitive tender.
Secondly, the HTA Programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour.
Thirdly, through its Technology Assessment Report (TAR) call-off contract, the HTA Programme commissions bespoke reports, principally for NICE, but also for other policy-makers. TARs bring together evidence on the value of specific technologies.
Some HTA research projects, including TARs, may take only months, others need several years. They can cost from as little as £40,000 to over £1 million, and may involve synthesising existing evidence, undertaking a trial, or other research collecting new data to answer a research problem.
The final reports from HTA projects are peer-reviewed by a number of independent expert referees before publication in the widely read journal series Health Technology Assessment.
Criteria for inclusion in the HTA journal series
Reports are published in the HTA journal series if (1) they have resulted from work for the HTA Programme, and (2) they are of a sufficiently high scientific quality as assessed by the referees and editors.
Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.
The research reported in this issue of the journal was commissioned by the HTA Programme as project number 03/66/01. The contractual start date was in July 2005. The draft report began editorial review in January 2007 and was accepted for publication in October 2007. As the funder, by devising a commissioning brief, the HTA Programme specified the research question and study design. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the referees for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
The views expressed in this publication are those of the authors and not necessarily those of the HTA Programme or the Department of Health.
Editor-in-Chief: Professor Tom Walley
Series Editors: Dr Aileen Clarke, Dr Peter Davidson, Dr Chris Hyde, Dr John Powell, Dr Rob Riemsma and Professor Ken Stein
Programme Managers: Sarah Llewellyn Lloyd, Stephen Lemon, Kate Rodger, Stephanie Russell and Pauline Swinburne
© 2008 Crown Copyright Top ^