Professor Kate Gillies

Biography

I am an MRC Senior Non-Clinical Fellow and Professor working in Methodological Research related to participant centred trials. I am also the  Director of the Unit's Health Care Assessment Programme.

My research interests focus on the design and delivery of participant centred trials: from point of initial contact through to feeding back results to individuals.   I  lead research in the application of behavioural science to trials methodology. For example, framing problems of recruitment and retention as behaviours and exploring the opportunities to improve these aspects through the design of participant centred, theoretically informed, interventions. This work is multi-disciplinary and multi-stakeholder and involves using mixed methods approaches to develop, evaluate and implement interventions to support decision making in this context. To find out more about specific project please click on the 'Research' tab at the top of the page. My research has been supported by various funders.

I also lead the  mixed-methods process evaluations in many of our trials to improve both the experience for potential participants and the overall efficiency of the trial.  Work in this area is ongoing across the portfolio of CHaRT trials.

Visual abstract of our STEER project which used behavioural approaches to develop interventions to address trial retention. Full paper here.

Prizes and Awards

MRC Senior Non-Clinical Fellowship 2023-2028. Medical Research Council.

MRC Strategic Skills Methodology Research Fellowship 2014-2019. Medical Research Council.

CSO Postdoctoral Research Training Fellowship 2009-2012. Chief Scientist Office of the Scottish Government.

Research Overview

Trials methodology; behavioural science; behaviour change; participant experience; process evaluations; mixed-methods.

Current Research

Methodological research related to RCTs

Behavioural approaches to trials methods

I lead several projects (or work packages within projects) that have applied behavioural science to understand key trial problems such as recruitment and retention. These include:

• What are the key challenges and opportunities for mounting a trial of prehospital REBOA? A behavioural diagnosis to inform a definitive evaluation (PPRO_Behave)
• Systematic Techniques to Enhance Retention in RCTs: The STEER Project
• Behavioural approaches to explore factors that affect questionnaire return in the CGALL trial. The figure below illustrates the overarching themes related to questionnaire return with the relevant TDF domains mapped against each theme. 

I also supervise PhD candidates in this area as lead academic supervisor or lead methods expert:

• Behavioural interventions to improve clinical trial recruitment and retention
• Recruiter experience of recruiting pregnant women to clinical trials (The ENCOUNTER Study)

Other recently completed or ongoing trials methods projects that I lead

• Development of a core outcome set for the EvaLuation of Interventions for informed Consent for randomIsed controlled Trials: The ELICIT Study. ELICIT, the first methodological core outcome set, was developed to identify what outcomes should be considered in evaluations of interventions that aim to improve decisions about participation in a clinical trial.  The photo above was taken at the final consensus meeting which was held in Aberdeen in February 2020and brought together a range of stakeholders to help build agreement on the most important outcomes. Full paper here

• PRioRITY II: Prioritising Retention in Randomised Trials – I led a multi-stakeholder James Lind Alliance Priority Setting Partnership to identify the Top 10 unanswered questions for methods research on trial retention. Full paper here.

• Strategies to improve retention in randomised trials. I led the recent collaborative update of this Cochrane review.
• RECAP: Feedback matters: How should trial results be reported back to participants? The RECAP project has generated participant-centred, evidence-based recommendations for trialists to implement the dissemination of results to trial participants. The findings from RECAP are informing the Health Research Authority’s update to dissemination of trial results guidance.

Process evaluations within ongoing RCTs

• C-GALL - A randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of laparoscopic cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones. Methodological research projects that I lead linked to this trial include:
• Development of core outcome set for symptomatic uncomplicated gallstone disease
• A mixed-methods study exploring discussions of retention in clinical trial consultations

• UK REBOA: A randomised controlled trial of the effectiveness, and cost-effectiveness, of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for trauma. Process evaluation applying a behavioural approach to improve recruitment to the trial through identification of barriers and implementation of behavioural solutions.
  • Behavioural optimisation to address trial conduct challenges: case study in the UK-REBOA trial | Trials | Full Text (biomedcentral.com)

• REGAL: Recurrence of Endometriosis: A randomised controlled trial of clinical and cost-effectiveness of Gonadotrophin Releasing Hormone Analogues with add-back hormone replacement therapy. Started recruitment in 2021.
• DIAMOND: Deep infiltrating endometriosis: management by medical treatment versus early surgery. Started recruitment in 2022.

Other applied Health Services Research Projects

I-TRAC - In-home Tracking of glaucoma: Reliability, Acceptability, and Cost: the I-TRAC Study (Chief Investigator)

REINFORCE - Real-World Evaluation of Robot-Assisted Surgical Services (REINFORCE): Work Package 1 - Optimisation of RAS implementation and scale up  (Methodological lead)

RoboCOS: What outcomes are important for evaluating robotic assisted surgery as a service-level change? An outcome mapping exercise to inform core outcome set development  (Methodological lead)

TestES Consortium: Testosterone Effects and Safety in Men with Low Testosterone levels  (Methodological lead)

Collaborations

I actively collaborate with other methodologists and trial teams both nationally and internationally on a range of trials methodology projects, highlights include:

• ORINOCO: Optimising Resource-use IN Outcome Collection
• PoINT: Public involvement in Numerical aspects of Trials
• PACT: Patient-centred trials (PACT): developing measures to improve the experience of people taking part in clinical trials
• Developing and Testing Participant Information Leaflets (PILs) that Inform and do not Cause Harm (PrinciPILs)
• BadRaP: Using behavioural science to understand and improve participation in clinical trials

Funding and Grants

I have been involved as a co-applicant and work package lead on a portfolio of national and international grants generating in excess of £17.4 million, with almost £1.5 million as Chief Investigator, predominantly over the past 5 years. These awards include a range of funders, methodological and applied research, but all are relevant for national or international healthcare. Select awards over past 5 years include:

• Goulao B, Morris T, Gamble C, Blazeby J, Ramsay C, Totton N, Laidlaw L, Soulsby I, Stewart D, Gillies K. INITIAL: Involving patients and the public In sTatistIcal Analysis pLans. MRC-NIHR Trials Methodology Research Partnership. 2021-22. £9,492.
• Soomro N, Gillies K, Breckons M, Challacombe B, MacLennan G, Vale L, Narahari K, Sheerin N, Stewart G, Nicol D, di Mambro D, Heer R. The PARTIAL study – a randomised trial of the clinical and cost effectiveness of PARTIAL vs radical nephrectomy for clinically localised renal cell carcinoma. NIHR HTA. 02/22-01/27. £1876106

• Gillies K (CI), Duncan E, MacLennan G, LeBrec V, Lendrum R. What are the key challenges and opportunities for mounting a trial of prehospital REBOA? A behavioural diagnosis to inform a definitive evaluation. 10/21-03/22

• Treweek S, Gardner H, Gillies K, Witham M, Devane D, Khunti, Bower P, Parker A, Oshisanya A, Soulsby I. . Improving ethnic diversity in trials: helping trial teams recruit and retain the ethnic groups essential for results with community-wide relevance and applicability. Chief Scientist Office of the Scottish Government’s Health & Social Care Directorate. 11/21-03/23 £188146.
• Williamson P, Yap C, Eldridge S, Gillies K, Hughes D, Gates S, Jaki T, Taylor R, Walwyn R, Tudur-Smith C, Vale C,  Wason J, Hosking J. Doctoral Training Programme 2021 – Trials Methods Research . Medical Research Council. 09/22-09/26. £2,518,806
• Beard D, Matthew C, Harji D, McGaughey F, Torkington J, McGrath J, Gillies K, Davies L, Vale L, MacLennan G, Soomro N, Bhattarai N, Bach S, Shaikh S, Campbell MK. A Real-World, In-Situ, Evaluation Of The Introduction And Scale-Up Of Robot-Assisted Surgical Services In The NHS: Evaluating Its Impact On Clinical And Service Delivery, Effectiveness And Cost. NIHR HSDR 01/22-03/25. £1359238
• Howick J, Gillies K, Treweek S, Bower S, Edwards A, Bostock J, Hood K. PrinciPIL: Developing and Testing PILs that do not Cause Harm. MRC Better methods, better research Programme.  MRC Better Research, Better Methods Programme.   £312,832 01/21 - 08/22
• Shiely F, Issacs T, Finucane E, Treweek S, Gillies K, O’Sullivan L. Understanding the language and complexity of informed consent in clinical trials and identifying participant preferences and understanding of key trial processes - randomisation. Health Research Board Trials Methodology Research Network.  01/21- 10/21. £9997. 
• Houghton C, Biesty L, Gillies K, Rousseau N, Wade J, Gamble C. Qualitative data sharing practices in clinical trials in the UK and Ireland: Towards the production of good practice guidance. Health Research Board Trials Methodology Research Network.  01/21- 10/21. £9514.
• Cooper K, Clark J, Gillies K, Maclennan G, Scotland G, Bhattacharya S, Cox E, Horne A, Byrne D, Smith P, Amer S, Gamaleldin I, Vashisht A, Murchie P. Deep Infiltrating Endometriosis: Management by Medical Treatment or Early Surgery (DIAMOND). NIHR HTA Programme. 02/21. £1,528,925
• Brehaut J, Presseau J, Gillies K, Grimshaw J, Ramsay C, Duncan E, Fergusson D, Marlin S, Graham I, Spencer H, Weijer C, Taljard M, Gordon J, Richards D, Rodger M.  Using behavioural science to understand and improve participation in clinical trials. CIHR. 02/21-02/26
• Gillies K (CI), Azuara-Blanco A, Hernandex R, Forrest M, Maclennan G. Digital technologies for home monitoring glaucoma: a feasibility study. NIHR HTA Programme. January 2020. £289,313 
• Gillies K (CI) & Clarke M. Strategies to improve retention to randomised trials. NIHR Incentive Scheme. £8833. January 2020.
• Williamson PR, Emsley R, Sydes M, Land T, Brown J, Lalloo D, Mabey D, Hood K, Devane D, Farrell B, Allen E, Kirkham J, Gillies K, Yap C, Blazeby J, Avery K, Weir C, Jaki T, Wason J, Hughes D, Farron A, Morris T, Landray M, Wordsworth S, Villar Moreschi S. Trials Methodology Research Partnership, Medical Research Council. 06/19. £458,665
• Gillies K (CI), Knapp P. Hunn A, Humphreys R, Entwistle V, Campbell M. Feed back matters: how should trial results be fed back to trial participants? Academy of Medical Sciences. 11/17-10/19. £99,964. 23.
• Gillies K (CI), Treweek S, Bower P, Young B, Witham M, Wells M, Francis J. Developing theory based interventions to minimise drop-out in randomised trials. Chief Scientist Office of the Scottish Government’s Health & Social Care Directorate. 08/17 – 09/19. £249,649

Teaching Responsibilities

I teach on the Qualitative Methods module for the Masters in Public Health. I supervise Masters students across the MPH and other in-person and online Masters courses. I contribute to the Real World RCTs and PPI in trials modules that HSRU has developed.