BSPED2013 Poster Presentations (1) (89 abstracts)
Screening log data can be used to inform protocol modifications, increasing patient recrutiment to a challanging clinical trial
Jo Blair 1 , Lola Awoyale 2 , Keith Thornborough 1 , Matthew Peak 1 , Mohammed Didi 1 , Emma Bedson 2 , Dyfrig Hughes 3 , Colin Ridyard 3 , Tri Tat 4 & John Gregory 5
1Alder Hey Children’s NHS Foundation Trust, Liverpool, UK; 2Liverpool University, Liverpool, UK; 3Bangor University, Bangor, UK; 4Manchester University, Manchester, UK; 5Cardiff University, Cardiff, UK.
Background: Delivery of clinical trials to time and target is critical for studies to be financially viable and relevant. Feasibility studies are informative. However, protocol acceptability and recruitment rates can only be accurately ascertained once a study is open.
The SCIPI study (SubCutaneous Insulin: Pumps or Injections?), randomises patients to treatment with multiple daily injections (MDI) or pumps at diagnosis of type I diabetes (TID). A consent rate of 50% of eligible patients is required to achieve target recruitment (316 patients from 14 centres). We report how screening logs informed protocol changes to optimise recruitment.
Methods: The following data were recorded: time from diagnosis to i) screening, ii) information giving, iii) consent, iv) randomisation and v) start of randomised treatment. Reasons given for declining to participate, or not inviting a patient to participate were recorded. These data were used to inform changes to study protocol.
Results: Patients who consented were approached earlier than those who declined (median 3.0 vs 6.5 days). Most patients who declined stated a strong preference for MDI. The commonest reasons for ineligibility were: i) first degree relative with TID and ii) inability to complete study questionnaires. Eligible patients were not invited to participate when centres were unable to initiate pump therapy within protocol timelines. In response to these data research staff were encouraged to approach patients early. Eligibility criteria were refined so that patients with a parent, but not a sibling with TID could participate and families who were not fluent in written English could be supported to complete questionnaires. Protocol timelines were also revised. These interventions resulted in an improvement in recruitment rate from 44.7 to 56.6%.
Conclusion: Screening log data can be utilised to address the needs of research staff and families, invited to participate in a study at a time of great uncertainty.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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