Table 3 Illustrative examples of QRI analysis from three of the initial 12 RCTs showing how the evidence/clues found in the RCT’s documents and accrual data supported the identification of new previously hidden/underestimated recruitment barriers and suggested remedial actions

I2

Three drugs for feverish infants (primary care/ paediatrics)

Accrual data showed only a small percentage of eligible parents were enrolled [21]. Interviews revealed that recruiters were uncomfortable discussing the RCT with parents whose children they considered too unwell [18]. Recruiters approached only a small number of parents—those whose children were not distressed and whom they believed would agree to participate [34].

Issues with eligibility, equipoise, approaching patients

Reconsider interpretation of eligibility criteria with RCT team [17]. Provide QRI training/support for recruiters about how to approach all eligible parents [35].

I5

Radiation v. surgery for cancer

Accrual data showed wide variations between sites in numbers of RCT-eligible patients [21]. In interviews, specialists admitted they were uncomfortable introducing the RCT to patients with particular disease features, even though they met the RCT eligibility criteria [18]. Recruiters reported that patients declined randomisation because they preferred one of the interventions (usually surgery). Analysis of patient information found terminology describing surgery as the ‘gold standard’ and a lack of balance in descriptions of the interventions [28].

Issues with eligibility, equipoise, patient preferences, study presentation

Discuss interpretation of eligibility criteria and equipoise with RCT site PIs [20]. Provide QRI training/support for recruiters about how to manage patient preferences [22]. Provide suggestions to change patient information [23].

I4

Social (employment) intervention v. usual care, psychiatry

Interviews, audio-recordings, and analysis of patient information revealed that recruiters favoured the intervention arm over the control [18]. Recruiters found aspects of the randomised design difficult and misrepresented it [23]. Recruiters approached only patients they considered well enough for the RCT’s social intervention.

Issues with equipoise, study presentation, approaching patients, eligibility

Discuss equipoise issues and definition of usual care with RCT team [20]. Provide training/support for recruiters about RCT design and how to approach all eligible patients [35].