Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study

Raftery, J., Bryant, J., Powell, J., Kerr, C. and Hawker, S. , NCCHTA (2008) Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. Health Technology Assessment, 12 (10), 1-128.

Abstract

Aim/Principal Research Question:
The systematic review had three aims:
• to synthesise the evidence on the effectiveness of offering monetary incentives to healthcare professionals to recruit patients to clinical trials;
• to provide an overview of the ethical issues as debated in the published literature;
• to identify current UK guidelines on financial incentives to healthcare professionals to recruit patients to trials.

The primary research aimed to:
• to identify the attitudes, beliefs and behaviour of healthcare professionals and consumers in relation to financial incentives for recruitment to trials;
• to explore how financial incentives are 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.

Methods:
Electronic databases including the Cochrane Library, Medline, Embase, CINAHL, PsycINFO, Science Citation Index/Social Science Citation Index, Current Controlled Trials and the National Research Register were searched from inception to June 2006 for published English language studies of any payment or reimbursement to any healthcare professional recruiting patients to trials with reported recruitment rates. Bibliographies and grey literature were also searched. Inclusion criteria, data extraction and quality assessment were undertaken independently by two investigators using standard systematic review methodology. Quality assessment used the DuRant tool. Synthesis was by narrative review with full tabulation of results from all included studies.
The qualitative investigation involved semi-structured interviews with purposive samples of healthcare professionals and healthcare consumers. Sampling of individuals for interview was from the National Research Register, National Coordinating Centre for Health Technology Assessment and through ‘snowballing’. Interviews were transcribed verbatim and entered into NVivo software for analysis and management. A hierarchical coding system was devised centred around themes of ‘motivation’ and ‘incentives’ for healthcare professionals, and ‘patient experiences’ and ‘incentives’ for consumers. Data is presented as representative quotations.

Sample groups:
Healthcare professionals and consumers, and research managers from pharmaceutical companies.

Outcome measures:
The primary outcome measure of the systematic review was level of patient recruitment. Secondary outcomes included other measurements of recruitment such as achievement of sample size, proportion of patients with full follow-up, qualitative measures of professional attitudes and of effects on participants.
Motivating and facilitating factors and barriers to participating in research for healthcare professionals were the outcomes of the qualitative study, along with attitudes of consumers and industry research managers to incentives.

Findings:
Three cross-sectional surveys were identified which met the inclusion criteria. These considered recruitment rates and the attitudes and characteristics of clinicians in relation to some financial incentive or reimbursement. One primary care study reported that successful patient recruitment is determined more by motivation driven by the research group than by financial incentives, the research topic or research experience. The other primary care study concluded that patient recruitment by GPs may be aided by the use of a range of strategies including financial reimbursement, which might be enhanced by closer collaboration between GPs and researchers.
The hospital based study found that reimbursement to the participating clinics was of only minor importance for both participation in trials and for recruiting patients. The scientific aims of the study were considered to be the most important factor with ethical considerations and communication between participants and researchers also of importance.
In existing UK guidelines, the issues around payments to clinicians or patients are implied rather than stated, usually linked to discussion of conflict of interest and disclosure of any such conflicts. Interviews with NHS health professionals, mainly research active clinicians, indicated concerns over the likely effects of payment. While reimbursement of expenses incurred to do research was strongly supported, payment to incentivise recruitment was not. Direct payment to clinicians linked to recruitment or to research involvement was rare in publicly funded trials. A code of practice for any such payments was suggested, closely linked to the principles of Good Clinical Practice in research. Other 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 payments to clinicians linked to patient involvement 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 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.

Conclusions:
The available evidence on the effectiveness of payment to healthcare professionals for patient recruitment to trials is very limited in quality and quantity and is inconclusive.
The ethical stance outlined in Good Clinical Practice in research, despite lack of scientific support, was widely endorsed. These preclude payment to patients and allow reasonable payments to clinicians, subject to disclosure of any possible conflicts of interest. Within these principles, 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.

Implications for further research:
The authors recommend research on:
1. Improved reporting of those organisational aspects of trials that are known to affect recruitment, including the type and extent of payments.
2. Retrospective analysis of the factors associated with different levels of recruitment to RCTs, including payment of expenses to patients.
3. 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.
4. Qualitative research on participants’ experiences of being involved in different kinds of trials, and also to do with the appropriateness the guidelines on payment for participation.
5. Consideration by funders of clinical trails of proposals to include within trials experiments with payments methods, comparing different levels of disclosure and of payment.

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