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  1. Article

    Open Access

    Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions

    The COVID-19 pandemic impacted the operationalisation of non-COVID-19 clinical trials globally, particularly site and participant recruitment and trial success/stoppage. Trials which anticipate recruitment cha...

    Ava Lorenc, Leila Rooshenas, Carmel Conefrey, Julia Wade, Nicola Farrar in Trials (2023)

  2. Article

    Open Access

    Understanding the perspectives of recruiters is key to improving randomised controlled trial enrolment: a qualitative evidence synthesis

    Recruiting patients to randomised controlled trials (RCTs) is often reported to be challenging, and the evidence base for effective interventions that could be used by staff (recruiters) undertaking recruitmen...

    Nicola Farrar, Daisy Elliott, Catherine Houghton, Marcus Jepson, Nicola Mills in Trials (2022)

  3. Article

    Open Access

    Development of a new adapted QuinteT Recruitment Intervention (QRI-Two) for rapid application to RCTs underway with enrolment shortfalls—to identify previously hidden barriers and improve recruitment

    Many randomised controlled trials (RCTs) struggle to recruit, despite valiant efforts. The QRI (QuinteT Recruitment Intervention) uses innovative research methods to optimise recruitment by revealing previousl...

    Jenny L. Donovan, Marcus Jepson, Leila Rooshenas, Sangeetha Paramasivan in Trials (2022)

  4. Article

    Open Access

    Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework

    Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexit...

    Caroline Wilson, Leila Rooshenas, Sangeetha Paramasivan, Daisy Elliott in Trials (2018)

  5. Article

    Open Access

    Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)

    Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure ...

    Julia Wade, Daisy Elliott, Kerry N. L. Avery, Daisy Gaunt, Grace J. Young in Trials (2017)

  6. Article

    Open Access

    Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)

    Pragmatic randomised controlled trials (RCTs) are considered essential to determine effective interventions for routine clinical practice, but many fail to recruit participants efficiently, and some really imp...

    Jenny L. Donovan, Leila Rooshenas, Marcus Jepson, Daisy Elliott, Julia Wade in Trials (2016)

  7. Article

    Open Access

    ‘The trial is owned by the team, not by an individual’: a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology

    Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was...

    Sean Strong, Sangeetha Paramasivan, Nicola Mills, Caroline Wilson in Trials (2016)

  8. Article

    Understanding the role of teamwork in recruitment to randomised controlled trials in surgical oncology-results from an exploratory study

    Sean Strong, Sangeetha Paramasivan, Caroline Wilson, Nicola Mills, Jenny Donovan in Trials (2015)

  9. Article

    Open Access

    A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing

    Recruitment to pragmatic randomised controlled trials (RCTs) is acknowledged to be difficult, and few interventions have proved to be effective. Previous qualitative research has consistently revealed that rec...

    Sangeetha Paramasivan, Sean Strong, Caroline Wilson, Bruce Campbell in Trials (2015)

  10. Article

    Open Access

    Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences

    Patients’ treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients’ treatment preferences and identified k...

    Nicola Mills, Jane M Blazeby, Freddie C Hamdy, David E Neal, Bruce Campbell in Trials (2014)

  11. Article

    Open Access

    The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase

    The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment. Laparoscopic adjustable gastric band and Roux-en-Y gastric bypass surgery are the ...

    Chris A Rogers, Richard Welbourn, James Byrne, Jenny L Donovan, Barnaby C Reeves in Trials (2014)

  12. Article

    Open Access

    Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials

    Recruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interve...

    Jenny L Donovan, Sangeetha Paramasivan, Isabel de Salis, Merran Toerien in Trials (2014)

  13. Article

    Open Access

    Evaluating best practice in informed consent discussions: a new method of evaluating information provision and patient understanding during trial recruitment consultations

    Julia Wade, Jenny Donovan, Sangeetha Paramasivan, Athene Lane, David Neal in Trials (2013)

  14. Article

    Open Access

    ‘Keep an open mind’: using qualitative research to make recruitment easier in the by-band randomised controlled trial

    Sangeetha Paramasivan, Chris Rogers, Graziella Mazza, Jane Blazeby, Jenny Donovan in Trials (2013)

  15. Article

    Open Access

    A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing

    Sangeetha Paramasivan, Sean Strong, Caroline Wilson, Jane Blazeby, Jenny Donovan in Trials (2013)

  16. Article

    Open Access

    Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011)

    Recruitment to randomised controlled trials (RCTs) with very different treatment arms is often difficult. The ProtecT (Prostate testing for cancer and Treatment) study successfully used qualitative research me...

    Sangeetha Paramasivan, Robert Huddart, Emma Hall, Rebecca Lewis, Alison Birtle in Trials (2011)