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Key Papers Introducing Methodology of the QRI

J Donovan et al., 2022, Trials.
Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The QuinteT Approach
L Rooshenas et al., 2019, Qualitative Health Research.
J Donovan et al., 2016, Trials.

Recently Published

S Faisal et al., 2025, Health Expectations
J Wade et al., 2024, EClinicalMedicine.
N Mills et al., 2024, BMJ Open.
J Dos Santos et al., 2024, J Clin Epidemiol.
  

Methodology of the QRI

 
R Lewis et al., 2020, Trials.
 
Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The QuinteT Approach
L Rooshenas et al., 2019, Qualitative Health Research.
 
The Quintet Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. 
L Rooshenas et al., 2018, Journal of Clinical Epidemiology.
 
Development of a framework to improve the process of recruitment to Randomised Controlled Trials (RCTs): The SEAR (Screened, Eligible, Approached, Randomised) framework. 
C Wilson et al., 2018, Trials.
Training key personnel to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT RCT recruitment Training Intervention. 
N Mills et al., 2017, J Clin Epi.
Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). 
J Donovan et al., 2016, Trials.
A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT – quanti-qualitative appointment timing. 
S Paramasivan et al., 2015, Trials.
 
It’s not just what you say, it’s also how you say it: Opening the ‘black box’ of informed consent appointments in randomized controlled trials. 
J Wade et al., 2009, Social Science and Medicine.

 

Screening

The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial
R Lewis et al., 2020, Trials.
 
Development of a framework to improve the process of recruitment to Randomised Controlled Trials (RCTs): The SEAR (Screened, Eligible, Approached, Randomised) framework. 
C Wilson et al., 2018, Trials.

 

Equipoise Issues

The role of healthcare professionals’ communication in trial participation decisions: a qualitative investigation of recruitment consultations and patient interviews across three RCTs
N Farrar et al., 2024, Trials.
Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials. 
L Rooshenas et al., 2016, PloS Medicine.
 
Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. 
N Mills et al., 2003, Controlled Clinical Trials.
 
The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. 
J Donovan et al., 2014, Journal of Clinical Epidemiology.

 

Randomisation

An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. 
M Jepson et al., 2018, Journal of Clinical Epidemiology.

 

Dealing with Patient Preferences

Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences. 
N Mills et al., 2014, Trials.
 
Exploring treatment preferences facilitated recruitment to randomized controlled trials. 
N Mills et al., 2011, Journal Clinical Epidemiology. 

 

Common RCT Recruitment Challenges and Solutions

A Lorenc et al., 2023, Trials.
Understanding the perspectives of recruiters is a key to improving randomised controlled trial enrolment: a qualitative evidence synthesis
N Farrar et al., 2022, Trials.
 
G Davies et al., 2020, Trials.
An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. 
M Jepson et al., 2018, Journal of Clinical Epidemiology.
 
The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. 
J Donovan et al., 2014, Journal of Clinical Epidemiology.
Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. 
J Donovan et al., 2014, Trials.
 
Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials. 
L Rooshenas et al., 2016, PloS Medicine.

 

Informed Consent

M Alvarez et al., 2023, Pilot and Feasibility Studies.
 
J Wade et al., 2023, Trials.
 
Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action
A Russell et al., 2023, Trials.
 
Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of participatory and informed consent (PIC). 
J Wade et al., 2017, Trials.
Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). 
J Donovan et al., 2016, Trials.
 
It’s not just what you say, it’s also how you say it: Opening the ‘black box’ of informed consent appointments in randomized controlled trials. 
J Wade et al., 2009, Social Science and Medicine.

 

QRIs Applied to Trials

Alba X Realpe et al., 2021, Bone & Joint Open.
 
M Jepson et al., 2021, Trials.
 
R Lewis et al., 2020, Trials.
 
Pre-trial Qualitative Work with Health Care Professionals to Refine the Design and Delivery of a Randomised Controlled Trial on Kidney Care
S Husbands et al., 2019, Trials.
 
Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation versus radical prostatectomy for unilateral localised prostate cancer. 
D Elliott et al., 2018, BJU International.
Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial
E Crawley et al., 2018, Arch Dis Child.
 
Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study. 
S Paramasivan et al., 2017, International Journal of Obesity.
A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented. 
A Realpe et al., 2016, Journal of Clinical Epidemiology.
Optima Prelim: a randomised feasibility study of personalised care in the treatment of women with breast cancer. 
R Stein et al., 2016, Health Technology Assessment.
A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT – quanti-qualitative appointment timing. 
S Paramasivan et al., 2015, Trials.
The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomised controlled trial (SMILE study)
E Crawley et al., 2013, Trials.
 
Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). 
S Paramasivan et al., 2011, Trials.
Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. 
J Donovan et al., 2002, BMJ.
 

Origins and Development of the QRI

Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. 
J Donovan et al., 2002, BMJ.
Qualitative research to improve RCT recruitment: Issues arising in establishing research collaborations. 
I De Salis et al., 2008, Contemporary Clinical Trials. 
Using qualitative research methods to improve recruitment to randomized controlled trials: the Quartet study. 
I De Salis et al., 2008, Journal of Health Services Research & Policy.
Why is recruitment to trials difficult?  An investigation into recruitment difficulties in an RCT of supported employment for people with severe mental illness. 
L Howard et al., 2009, Contemporary Clinical Trials.
Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. 
J Donovan et al., 2009, Journal of Clinical Epidemiology.
The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer.   
D Hamilton et al., 2013, European Archives of Oto-Rhino-Laryngology and Head & Neck.
Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. 
N Mills et al., 2003, Controlled Clinical Trials.

 

Published RCTs with Integrated QRIs

Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. 
J Donovan et al., 2016, New England Journal of Medicine.
10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer 
F Hamdy et al., 2016, New England Journal of Medicine.
Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial 
P Mulvenna et al., 2016, The Lancet.
 
Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial.       
D Griffin et al., 2018, The Lancet.
 
Does laryngeal reinnervation or type I thyroplasty give better voice results for patients with unilateral vocal fold paralysis (VOCALIST): study protocol for a feasibility randomised controlled trial. 
H Blackshaw et al., 2017, BMJ.
 
Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. 
D Beard et al., 2017, The Lancet.
 
J M Blazeby et al., 2014, Br J Cancer.

Protocols of RCTs with embedded QRIs

Protocol for the Veterans Affairs Cooperative Studies Program Study Number 2005: A Phase 3 Randomized Trial of Lung Cancer Surgery or Stereotactic Radiotherapy for Operable Early-Stage Non-Small Cell Lung Cancer
D Moghanaki et al., 2023, CHEST Pumlonary.
 
Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy
K Roberts et al., 2021, BMJ Open.
 
Protocol for a mixed methods study to inform the feasibility of undertaking a large-scale multicentre study comparing the clinical and patient-reported outomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction (The ANTHEM feasibility study)
C Davies et al., 2021, BMJ Open.
 
E Lim et al., 2020, BMJ Open.
 
S Baos et al., 2018, Trials.
 

Recruiter Training

Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously
A Parker et al., 2022, Research Methods in Medicine & Health Sciences.
Training key personnel to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT RCT recruitment Training Intervention. 
N Mills et al., 2017, J Clin Epi.
A systematic review of training programmes for recruiters to randomised controlled trials. 
D Townsend et al., 2015, Trials.
 
Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences. 
N Mills et al., 2014, Trials.
Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. 
S Potter et al., 2014, Trials.

 

Other

L Beasant et al., 2023, Autism: International Journal of Research and Practice.
 
 
H Delaney et al., 2022, HRB Open Res.
 
Recruiters' perspectives and experiences of trial recruitment processes: a qualitative evidence synthesis protocol
N Farrar et al., 2022, BMJ Open.
 
Clinicians’ Views of Patient-initiated Follow-up in Head and Neck Cancer: a Qualitative Study to Inform the PETNECK2 Trial
A Lorenc et al., 2021, Clinical Oncology.
 
S Paramasivan et al., 2021, BMJ Global Health.

Qualitative study of clinician and patient perspectives on the mode of anaesthesia for emergency surgery
J Dooley et al., 2019, British Journal of Surgery.
 
Designing and using incentives to support recruitment and retention in clinical trials: a scoping review and a checklist for design
B Parkinson et al., 2019, Trials.
 
Factors associated with trial recruitment, preferences, and treatments received were elucidated in a comprehensive cohort study
J Donovan et al., 2019, J Clin Epidemiol.
 
 
Effectiveness of Community versus Hospital Eye Service follow-up for patients with neovascular age-related macular degeneration with quiescent disease (ECHoES): a virtual non-inferiority trial
B Reeves et al., 2016, BMJ Open.
 
B Reeves et al., 2016, Health Technol Assess.
The Inclusion of Ethnic Minority Patients and the Role of Language in Telehealth Trials for Type 2 Diabetes: A Systematic Review. 
T Isaacs et al., 2016, J Med Internet Res.
 
Standardising and monitoring the delivery of surgical interventions in randomised clinical trials
N Blencowe et al., 2016, Br J Surg.
 
S Strong et al., 2016, Trials.
 
N Blencowe et al., 2015, Trials.
 
The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). 
E Crawley et al., 2013, Trials.
Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent. 
Z Tomlin et al., 2012, Health Expectations.
Self-help smoking cessation in pregnancy: a cluster randomised controlled trial. 
L Moore et al., 2002, BMJ.
 
Understanding and improving recruitment to randomised controlled trials: Qualitative research approaches. European Urology. 
D Elliott et al., 2017, European Urology.
 
D Townsend et al., 2015, BMJ Open.
 
Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). 
E Crawley et al., 2013, Trials.
 
A review of reporting of participant and retention in RCTs in six major journals. 
M Toerien et al., 2009, Trials.

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