Theme aim

Over the five years of ConDuCT-II hub for trials methodology research (04/2014-03/2019), the key aim in theme 2 has been to extend the development of innovative, integrative and dynamic research methods developed during ConDuCT, with a view to optimising recruitment in trials in general and particularly those involving invasive procedures. Theme 2’s work and researchers closely overlap those of the University’s QuinteT Team who continue to pioneer and disseminate qualitative approaches to optimise recruitment and informed consent to randomised clinical trials (RCTs).  If you require recruitment related support after the ConDuCT-II period, please contact the QuinteT Team.

Major achievements

• Build a detailed understanding of the recruitment process in pragmatic trials.

  We have carried out several cross-trials syntheses of our qualitative research findings to illuminate recruiters’ perspectives on the clear obstacles and hidden challenges to recruitment and the intellectual challenges and emotional consequences of equipoise. We further explored the hidden challenges to recruitment from audio-recordings of recruitment consultations to understand how trial recruiters communicated key trial concepts such as randomisation and equipoise to patients as well as how they engaged with patient treatment preferences.

• Extend the development and application of the innovative, dynamic and integrative research methods developed in ConDuCT.

  The published version of the QuinteT Recruitment Intervention (QRI) protocol has now been employed across several RCTs. Methodological research aimed at further developing the QRI has included publications on the SEAR (screened, eligible, approached, randomised) framework, the Q-QAT (quanti-qualitative appointment timing) tool to rapidly identify recruitment issues, the PIC tool to measure informed consent in recruitment appointments and a six-step model to promote recruitment to RCTs.

• Develop and apply robust methods to evaluate the effectiveness of the evolving recruitment interventions.

  We carried out a before-after evaluation of the impact of our generic recruiter training programmes on self-confidence and perceived impact on recruitment and an observational evaluation of five completed RCTs with QRIs, both of which have shown promising results while highlighting the need for a randomised evaluations in the future.

• Critically appraise definitions of ‘pilot’ and ‘feasibility’ studies in collaboration with other HTMRs, and jointly write an expanded guide for designs of such studies for researchers.

  Theme 2 members were involved with the CONSORT statement extension for pilot and feasibility trials and on the guide to maximise the impact of qualitative research in feasibility studies for RCTs.

• Provide encouragement for the use of qualitative methods in RCTs more generally.

  Theme 2 members and affiliates have been involved in a large volume of publications and training programmes around the use of qualitative research methods in RCTs.  A book on using qualitative research with RCTs (a practical guide) has also been published by a theme 2 member.