Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: a case study.
BACKGROUND
It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community.


METHODS
Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres


RESULTS
Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale.


CONCLUSIONS
While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully achieved through the application of the best available evidence, establishing good relationships with practices, minimising the workload of those involved in recruitment and offering enhanced care to all participants. Primary care trialists should describe their experiences of the methods used to persuade patients to participate in their trials when publishing their results.
McKinstry
Brian
B
Community Health Sciences, University of Edinburgh, 20 W Richmond Street, Edinburgh, UK. brian.mckinstry@ed.ac.uk
Hammersley
Victoria
V
Daly
Fergus
F
Sullivan
Frank
F
D020330:Bell Palsy / Q000628:therapy*; D005149:Facial Expression; D005154:Facial Nerve / Q000503:physiopathology; D006801:Humans; D008402:Mass Media; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D011642:Publications; D016032:Randomized Controlled Trials as Topic; D012107:Research Design