Table 5 Finalised QRI-Two protocol
QRI-Two protocol | |
Analysis to diagnose the RCT’s recruitment barriers | Analysis of: Existing RCT documents (RCT protocol and patient information materials) to assess clarity of RCT design and details and study presentation RCT team’s summary of recruitment difficulties to understand known barriers Accrual monitoring data to assess complexity of recruitment pathway and variations in eligibility assessment and recruitment overall and by site |
Workshop (2–2.5 h) with RCT team to discuss findings of QRI-Two analysis and potential remedial actions | Workshop facilitated to: Present the findings from the QRI-Two analysis and relevant short QRI-informed training sessions Discuss findings in the context of the RCT team’s enrolment experiences Consider and propose potential remedial actions to improve recruitment |
Further work needed to tackle newly-diagnosed recruitment barriers | |
RCT team to decide whether recruitment barriers are insurmountable, or can be tackled with remedial actions to improve enrolment | |
Development and implementation of remedial actions to improve recruitment | (a) RCT team to devise own plan and remedial strategies, or (b) Support further collaboration with other groups* *Could include phase II of the QRI [14] |