Abstract
BackgroundRecruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention.MethodsIn total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection.ResultsWe achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention.ConclusionRecruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention.Trial registrationISRCTN24081411
Highlights
Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions
As high proportions of patient contacts occur in primary care, e.g. 90% within the National Health Service (NHS) [11], general practice offers the potential of access to large numbers of participants for research studies, but recruitment in this setting involves a particular succession of challenges
Practitioners' reasons range from deriving satisfaction in helping to establish correct treatment decisions to an opportunity for practice staff to participate in research: they may be attracted to participate in a study when they consider the research relevant and necessary, and the research study team experienced and supportive [12,13,14,15]
Summary
Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. As high proportions of patient contacts occur in primary care, e.g. 90% within the NHS [11], general practice offers the potential of access to large numbers of participants for research studies, but recruitment in this setting involves a particular succession of challenges. It is a two-step process, requiring firstly the consent of staff in an increasingly busy work environment where space and time are frequently limited, and the consent and commitment of sufficient numbers of eligible patients. Patients' reasons include potential advantages in care received (for example longer consultation time and regular physical measurements), the attitude of researchers, the quality of information supplied and altruism, hoping that their participation will benefit others [16,17]
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