Background: Recruiting to target in randomised controlled trials of investigational medicinal products (CTIMPs) in\nprimary care and paediatric populations is notoriously difficult. More evidence is needed for effective recruitment\nstrategies in these settings. We report on the impact of different recruitment strategies used in the Choice of\nMoisturiser in Eczema Treatment (COMET) study ââ?¬â?? a feasibility trial comparing the effectiveness of four emollients\nfor the treatment of childhood eczema ââ?¬â?? recruiting via general practitioner (GP) surgeries.\nMethods: Initially, 16 GP practices invited potentially eligible children to take part in the trial by sending an\ninvitation letter (self-referral pathway) or by consenting and randomising them into the study during a visit to\nthe practice (in-consultation referral). Measures implemented during the study to maximise accrual included signing\nup six additional GP practices, increasing the upper age limit eligibility criterion from 3 to 5 years, and permitting\nhealthcare professionals other than doctors to confirm participant eligibility. We used descriptive statistics and\nunivariate linear regression models to explore associations with practice recruitment rates.\nResults: A total of 197 participants were recruited, exceeding the target of 160. Of these, 107 children entered via\nself-referral and 90 by in-consultation pathways. Of the recruited population, 12.6 % were aged between 3 and\n5 years (the raised upper age limit). The six additional practices contributed 37.4 % (40 of 107) of participants\nrecruited by self-referral. Only almost one-third (18 of 56 [32.1 %]) of potential recruiting clinicians recruited one\nor more participants in-consultation, which was a more problematic pathway because of data verification issues.\nThree research nurses and a pharmacist from four practices recruited 48.9 % (44 of 90) of participants via this\npathway. Univariate linear regression models showed no evidence of association between the number of children\nrecruited via the self-referral pathway by practice and practice list size (p = 0.092) or practice deprivation decile\n(p = 0.270), but practice deprivation was associated with a higher number of children recruited in-consultation\n(p = 0.020) by practice.\nConclusions: Self-referral and in-consultation recruitment yielded similar numbers, but the in-consultation pathway\nwas more problematic. Future trials of this type should consider the condition, normal care pathway and number\nof potentially eligible children and be prepared to use multiple recruitment strategies to achieve recruitment\ntargets.
Loading....