Table 1.

Aims and research methods of the QRI protocol [14] and aspects included in the QRI-Two

QRI phase I	Aims	Analysis method
i) Interviews with RCT staff (investigators and front-line recruiters); sometimes patients	To explore key aspects of RCT design and recruitment pathway, views about interventions, intentions in relation to recruitment.	Qualitative thematic analysis
ii) Mapping a patient’s pathway through screening, eligibility, and randomisation, using screening logs and flow charts; accrual data	To identify patterns in screening and eligibility assessment and accrual data, for example differences in numbers screened, eligible, approached, and randomised in sites	Qualitative content analysis and simple quantification
iii) Audio-recordings of recruitment appointments where the RCT is presented by recruiters to eligible patients	To assess clarity of study presentation by recruiters (compared with intentions in interviews) and reactions of patients to study terminology	Qualitative thematic and conversation analysis
iv) Scrutiny of study documents, e.g. RCT protocol, patient information/consent forms, study websitea	To understand RCT design, purpose, evidence base, inclusion/exclusion criteria, recruitment pathway, and interventions in protocol, and clarity and consistency with patient information.	Documentary content analysis
QRI phase II	Aims
a) Present phase I findings to the CI/RCT teamb	To summarise details and evidence from the phase I findings about clear obstacles and hidden challenges to recruitment and propose remedial actions
b) Develop the plan of actions to optimise recruitment, and implement jointly with RCT team	To agree actions to optimise recruitment based on evidence from (a), e.g. feedback and training, site reviews, clarification of eligibility criteria, collection of additional accrual data, changes to study information, and repeat data collection, analysis, and reporting iteratively as above, as required

Aspects of QRI protocol included in QRI-Two:

^aData collection method included in QRI-Two

^bPresentation of QRI-Two findings specifically in a workshop format to facilitate discussion of newly diagnosed recruitment barriers and potential remedial actions