Publications

Recently Published

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.
 
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.

 

Methodology of the QRI

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

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

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.

 

Evaluation of the QRI

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.
 
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.

 

Common RCT Recruitment Challenges and Solutions

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

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

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.
  
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.
 
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.

 

Recruiter Training

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.
 
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

A systematic review of training programmes for recruiters to randomised controlled trials. 
D Townsend et al., 2015, Trials.
 
A review of reporting of participant and retention in RCTs in six major journals. 
M Toerien et al., Trials.
 
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.
 
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.
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