The ConDuCT Hub: Collaboration and Innovation for Difficult or Complex Randomised Controlled Trials

Lead Research Organisation: University of Bristol
Department Name: Social Medicine

Abstract

The overall aim of the MRC ConDuCT Hub is to provide the conditions for research staff to come together and develop new techniques to design and complete randomised controlled trials (RCTs). RCTs are the most powerful form of medical research that can change what doctors advise. RCTs can compare outcomes for patients receiving different treatments or compare new treatments with existing treatments, or a placebo (dummy treatment). Researchers assign participants to each treatment group at random to ensure that comparison between the two groups is scientifically accurate as all other things apart from the treatment are likely to be comparable in each group. Although RCTs provide good evidence, many are very difficult to design and complete, e.g. some are not completed because they are unable to recruit enough patients. Other RCTs are not started because the issues require complex design, conduct and analysis of results. The MRC ConDuCT Hub will concentrate on research that allows RCTs considered clinically important but too ?difficult?, to be undertaken successfully. The Hub should thus eventually lead to changes in clinical practice and better information for doctors and patients about which treatments to choose, based on the best evidence.
This will be achieved by bringing together an experienced team with different research backgrounds to develop new ways of carrying out RCTs. The Hub will be directed by a surgeon who works in the NHS and already carries out research to improve RCTs. Researchers in the Hub will work with other MRC Hubs across the UK and with NHS organisations in South West England and South Wales to carry out this work.
The ConDuCT Hub will provide a training programme of short courses and workshops based on each of six research themes. This will provide basic and advanced learning opportunities for researchers and clinicians designing and conducting RCTs. New courses and PhD studentships will be provided in the specialist research areas.
In conclusion, the ConDuCT Hub will bring together researchers and clinicians to improve the design of RCTs. This will lead to more and better RCTs being started and completed. The ConDuCT Hub will focus on tackling important questions about the best treatments and should lead to better information for patients and doctors making decisions about which treatments to use.

Technical Summary

The overall aim of the MRC ConDuCT Hub is to provide the environment and infrastructure for the conduct of collaborative methodological research that will lead to marked improvements in the successful design and completion of randomised controlled trials (RCTs). The Hub will focus particularly on developing nationally and internationally leading methodological research for RCTs considered ?difficult? because of methodological complexity, clinical controversy, or recruitment challenges. This will be achieved by bringing together a critical mass of experienced multi-disciplinary researchers to develop novel applications of research methods. The Hub will be directed by a clinician with an established record of collaborative work within RCTs. The Hub will work nationally with other MRC Hubs to support the conduct of challenging or complex RCTs, and regionally, the Hub will support RCTs in general in collaboration with UKCRC-registered Clinical Trials Units (CTUs) and the NIHR Research Design Service
The ConDuCT Hub comprises six major research themes: developing and integrating qualitative research methods to improve design and conduct, evidence synthesis and expected value of information for design and prioritisation, improving RCT monitoring and conduct, integrating patient reported outcomes and clinical data, and statistical and economic methods for design and analysis. Each theme will work individually and collaboratively to support the wider UK RCT network. Close links with CTUs will hasten translation of methodological findings into developing and ongoing RCTs.
The ConDuCT Hub will provide a training programme comprising short courses and workshops based on the methodological research themes to provide basic and advanced learning opportunities in RCT methodology and application for researchers and clinicians designing and conducting RCTs. Courses to be provided in the design and analysis of RCTs will include existing introductory courses for qualitative research methods, statistics and health economics; questionnaire design and analysis; and new courses including: integrating qualitative methods in RCTs, incorporating patient reported outcomes with clinical outcomes in RCTs and introduction to expected value of information for decision-modelling. There will also be one-day workshops for specific issues relevant to complex RCTs. PhD studentships will provide advanced training in RCT methodology.
In conclusion, the ConDuCT Hub will permit the rapid development of research methods for RCTs by enabling experienced and developing researchers to dedicate substantial time to each methodological theme, and, through existing and new inter-theme collaboration, enable the design, conduct and analysis of ?difficult? RCTs at the cutting edge of health improvement.

Publications

10 25 50

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Ades AE (2011) Indirect and mixed treatment comparisons in arthritis research. in Rheumatology (Oxford, England)

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Ades AE (2013) Evidence synthesis for decision making 7: a reviewer's checklist. in Medical decision making : an international journal of the Society for Medical Decision Making

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Ades AE (2010) Network meta-analysis with competing risk outcomes. in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

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Ades AE (2011) ISPOR states its position on network meta-analysis. in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

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Ades AE. (2009) Bayesian Evidence Synthesis in M Kattan (Ed). Sage Encyclopedia of Medical Decision Making 2009

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Al-Janabi H (2013) An investigation of the construct validity of the ICECAP-A capability measure. in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

 
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Funding ID G1001338 
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Sector Academic/University
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Description NIHR HTA Effectiveness and cost-effectiveness of new anticoagulants for venous thromboembolism and stroke prevention in atrial fibrillation.
Amount £300,355 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description NIHR HTA: Which method is best for the induction of labour: A systematic review, network meta-analysis and cost effectiveness analysis.
Amount £121,968 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description NIHR MRC grant [ConDuCT-II]
Amount £1,102,323 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 04/2014 
End 03/2019
 
Description NIHR Programme (Mild depression and antidepressants)
Amount £2,334,673 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description NIHR Programme development grant (Towards safer delivery and monitoring of cancer treatments. Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID))
Amount £150,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description NIHR Public Health Research Programme (Active For Life Year 5: A cluster randomised controlled trial of a primary school-based intervention to increase levels of physical activity, decrease sedentary behaviour and improve diet)
Amount £1,464,457 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description NIHR Research Methods Fellowship and Internship
Amount £128,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description NIHR Research Methods Fellowship and Internship Award [Methods of estimating cost-effectiveness in RCTs...]
Amount £91,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description NIHR Research for Patient Benefit Programme (Cluster randomised controlled trial to test the effectiveness of an educational intervention to promote hand washing in reducing absenteeism in primary schools)
Amount £242,230 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start  
 
Description NIHR RfPB (Comparing hospital and telephone follow-up for women treated for endometrial cancer (ENDCAT: Endometrial Cancer Telephone follow-up trial)
Amount £42,260 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start  
 
Description NIHR RfPB (Extension of Evaluating the Effect of Screening Cancer Patients using the Distress Thermometer on Levels of Distress and Health Service Costs)
Amount £21,226 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start  
 
Description NIHR RfPB (Trial to evaluate the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in hospice home care)
Amount £3,475 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start  
 
Description NIHR fellowship (Development of a core outcome set for informed consent and trials in colorectal cancer)
Amount £263,299 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description Optimal personalised treatment of breast cancer using multi-parameter analysis: preliminary study (OPTIMA)
Amount £1,959,668 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description Optimising diagnosis of symptomatic cancer (DISCOVERY)
Amount £1,945,945 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description Optimising the design and evaluation of pilot work to inform efficient RCTs: a workshop to consider the key issues and areas for future research
Amount £9,700 (GBP)
Organisation Medical Research Council (MRC) 
Department MRC Hubs for Trial Methodology Research
Sector Public
Country United Kingdom
Start 09/2013 
End 05/2014
 
Description PROVIDE -- NIHR Public Health Programme grant
Amount £1,906,972 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description PeriOperative chemotherapy or sUrveillance for upper Tract urothelial cancer (POUT)
Amount £798,000 (GBP)
Organisation Cancer Research UK 
Department CTAAC Clinical Trials Advisory & Awards
Sector Charity/Non Profit
Country United Kingdom
Start  
 
Description Promoting childrens physical activity via enhanced after-school leadership
Amount £461,463 (GBP)
Funding ID MR/J000191/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start  
 
Description Quality of Life Reporting Standards: Development of a CONSORT extension
Amount £49,450 (GBP)
Organisation Medical Research Council (MRC) 
Department Network of Hubs for Trials Methodology Research (HTMR)
Sector Academic/University
Country United Kingdom
Start  
 
Description RAFTA (Hewlett)
Amount £280,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 11/2013 
End 04/2018
 
Description Randomised controlled trial of silk therapeutic clothing for the long-term management of eczema in children (CLOTHES Trial: CLOTHing for the relief of Eczema Symptoms)
Amount £990,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description Randomised surgical trials: methods to improve recruitment and study design
Amount £11,550 (GBP)
Organisation Medical Research Council (MRC) 
Department Network of Hubs for Trials Methodology Research (HTMR)
Sector Academic/University
Country United Kingdom
Start  
 
Description Real-time Electronic Patient Outcome ReporTing of adverse events in UK cancer trials (REPORT UK)
Amount £299,000 (GBP)
Funding ID C7775/A14384 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start  
 
Description Recruitment and retention in clinical trials: current knowledge and future directions for research workshop
Amount £16,100 (GBP)
Organisation Medical Research Council (MRC) 
Department MRC Hubs for Trial Methodology Research
Sector Public
Country United Kingdom
Start  
 
Description Reducing pathology in Alzheimer's disease through angiotensin targeting (RADAR)
Amount £1,940,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start  
 
Description Research grant mapping outcomes G0901488
Amount £232,052 (GBP)
Funding ID G0901488 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start  
 
Description SPARE bladder cancer randomised trial
Amount £41,938 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start  
 
Description SYMPATHY: Stress and anxietY reduction using Mindfulness in Pulmonary ArTerial Hypertension
Amount £34,992 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start  
 
Description Surgical wounds healing by secondary intention: characterising and quantifying the problem and identifying effective treatments.
Amount £13,820 (GBP)
Funding ID RP-PG-0609-10171 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool
Amount £36,314 (GBP)
Organisation Medical Research Council (MRC) 
Department Network of Hubs for Trials Methodology Research (HTMR)
Sector Academic/University
Country United Kingdom
Start  
 
Description The COMET (Core Outcome Measures in Effectiveness Trials) Initiative (COMET FP7)
Amount £400,922 (GBP)
Funding ID 305081 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start  
 
Description The Oral Steroids for Acute Cough (OSAC) Trial
Amount £1,218,455 (GBP)
Organisation National Institute for Health Research 
Department School for Primary Care Research
Sector Academic/University
Country United Kingdom
Start  
 
Description The ROMIO trial - Randomised Oesophagectomy: Minimally Invasive or Open, a feasibility study
Amount £416,881 (GBP)
Funding ID 10/50/65 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description The Renoprotective value of Leukodepletion in Heart Valve surgery: an external feasibility randomised controlled trial (ROLO Trial)
Amount £239,920 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start  
 
Description The effectiveness of Community vs. Hospital Eye Service follow-up for patients with neovascular age-related macular degeneration with quiescent disease: a virtual trial (the ECHoES trial)
Amount £380,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description The effectiveness, acceptability and cost-effectiveness of psychosocial interventions for maltreated children and adolescents: An evidence synthesis.
Amount £335,124 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description The effectiveness, acceptability and cost-effectiveness of psychosocial interventions for maltreated children and adolescents: An evidence synthesis.
Amount £335,124 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description The effects of a comprehensive physiotherapy intervention for adults with joint hypermobility
Amount £373,474 (GBP)
Funding ID 10/98/05 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description The effects of a comprehensive physiotherapy intervention for adults with joint hypermobility.
Amount £329,881 (GBP)
Funding ID 10/98 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description The effects of schools and school-environment interventions on health: evidence mapping and syntheses
Amount £182,641 (GBP)
Funding ID 09/3002/08 
Organisation Public Health Research Consortium 
Sector Public
Country United Kingdom
Start  
 
Description The feasibility of a randomised controlled trial of dietary interventions for men at high risk of prostate cancer: the ProDiet study
Amount £40,000 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start  
 
Description Towards safer delivery and monitoring of cancer treatments. Electronic patient self- Reporting of Adverse-events: Patient Information and aDvice (eRAPID)
Amount £1,969,062 (GBP)
Funding ID RP-PG-0611-20008 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description Trial Steering Committees for Randomised Controlled Trials: Updating and Redeveloping Guidance and Terms of Reference, Informed By Current Practice and Experience
Amount £77,010 (GBP)
Organisation Medical Research Council (MRC) 
Department Network of Hubs for Trials Methodology Research (HTMR)
Sector Academic/University
Country United Kingdom
Start  
 
Description UK Feasibility Study of a trial of Arthroscopic Surgery for Hip Impingement compared with Non-operative care (UK FASHIoN)
Amount £236,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description Unblocs (Hashim)
Amount £1,200,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 01/2013 
End 12/2016
 
Description Use of the electronic health record in the design and conduct of clinical trials
Amount £20,900 (GBP)
Organisation Medical Research Council (MRC) 
Department MRC Hubs for Trial Methodology Research
Sector Public
Country United Kingdom
Start 11/2013 
End 11/2014
 
Description Using Conversation Analysis to study therapist-patient interactions from the IPCRESS trial of online CBT
Amount £70,000 (GBP)
Organisation BUPA 
Department BUPA Foundation
Sector Private
Country United Kingdom
Start  
 
Description WCRF - The causal role of the nutritionally regulated insulin-like growth factor system inprostate cancer: mendelian randomisation study
Amount £224,387 (GBP)
Organisation World Cancer Research Fund 
Sector Charity/Non Profit
Country Global
Start  
 
Description Wellcome Trust and Medical research Council: ALSPAC - an international resource for population genomics and lifecourse epidemiology
Amount £6,000,000 (GBP)
Organisation Wellcome Trust 
Department Wellcome - MRC Cambridge Stem Cell Institute
Sector Academic/University
Country United Kingdom
Start  
 
Description What are the indications for prescribing antidepressants that will lead to a clinical benefit? (PANDA)
Amount £2,000,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description What are the indications for prescribing antidepressants that will lead to a clinical benefit? NIHR programme grant.
Amount £1,999,968 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description What interventions improve outcomes for children exposed to domestic abuse: a systematic review, evidence synthesis, and research recommendations.
Amount £242,390 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description What interventions improve outcomes for children exposed to domestic abuse: a systematic review, evidence synthesis, and research recommendations.
Amount £242,390 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description What is/are the best oral anticoagulant/s for primary prevention, treatment and secondary prevention of venous thromboembolic disease, and for prevention of stroke in atrial fibrillation?
Amount £250,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description Which method is best for the induction of labour: A systematic review, network meta-analysis and cost effectiveness analysis.
Amount £162,371 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description Widening the spectrum of health outcomes used in health technology assessment: integrated synthesis and mapping QALYs.
Amount £232,052 (GBP)
Funding ID G0901488 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start  
 
Description Workshop on the design and analysis of clinical trials in Head and Neck cancer
Amount £5,500 (GBP)
Organisation Medical Research Council (MRC) 
Department MRC Hubs for Trial Methodology Research
Sector Public
Country United Kingdom
Start 06/2013 
End 04/2014
 
Description programme grant RP-PG-0609-10171 Negative pressure wound dressings
Amount £13,820 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start  
 
Description A conference on "maximising the value of qualitative research in RCTs", disseminating the findings of the MRC MRP funded QUART study 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Professor Jenny Donovan collaborated with the University of Sheffield (Professor O'Cathain) to organise a conference on "maximising the value of qualitative research in RCTs", disseminating the findings of the MRC MRP funded QUART study.
Collaborator Contribution NA
Impact NA
Start Year 2012
 
Description A methodological study examining the role of Trial Steering Committees and Trial Management Groups in 'difficult' decisions about trial conduct 
Organisation Medical Research Council (MRC)
Country United Kingdom 
Sector Academic/University 
PI Contribution Dr Ali Heawood together with Lane (trial conduct theme) collaborated with members of three other MRC Hubs for Trials Methodology Research (MRC CTU, North West and All-Ireland) and the University of Aberdeen to secure funding for and execute a methodological study examining the role of Trial Steering Committees and Trial Management Groups in 'difficult' decisions about trial conduct.
Collaborator Contribution NA
Impact NA
Start Year 2013
 
Description A proposal for a workshop at the Society for Clinical Trials annual meeting, Boston, USA, May 2013 
Organisation Medical Research Council (MRC)
Country United Kingdom 
Sector Academic/University 
PI Contribution Professor Jenny Donovan collaborated with the North West MRC Hub (Professor Young, and the Universities of Sheffield (Professor O'Cathain) and Stirling (Professor Hoddinott), in putting together a proposal for a workshop at the Society for Clinical Trials annual meeting, Boston, USA, May 2013. This led to their inclusion in the application for ConDuCT-II
Collaborator Contribution NA
Impact NA
Start Year 2013
 
Description A proposal for a workshop at the Society for Clinical Trials annual meeting, Boston, USA, May 2013 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Professor Jenny Donovan collaborated with the North West MRC Hub (Professor Young, and the Universities of Sheffield (Professor O'Cathain) and Stirling (Professor Hoddinott), in putting together a proposal for a workshop at the Society for Clinical Trials annual meeting, Boston, USA, May 2013. This led to their inclusion in the application for ConDuCT-II
Collaborator Contribution NA
Impact NA
Start Year 2013
 
Description A proposal for a workshop at the Society for Clinical Trials annual meeting, Boston, USA, May 2013 
Organisation University of Stirling
Country United Kingdom 
Sector Academic/University 
PI Contribution Professor Jenny Donovan collaborated with the North West MRC Hub (Professor Young, and the Universities of Sheffield (Professor O'Cathain) and Stirling (Professor Hoddinott), in putting together a proposal for a workshop at the Society for Clinical Trials annual meeting, Boston, USA, May 2013. This led to their inclusion in the application for ConDuCT-II
Collaborator Contribution NA
Impact NA
Start Year 2013
 
Description Aberdeen / Exeter - grant to advise re: recruitment strategies into the trial 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution Jane Blazeby to advise re: recruitment strategies into the trial
Collaborator Contribution Qualitative
Impact See Awards and Recognition
Start Year 2009
 
Description Aberdeen / Exeter - grant to advise re: recruitment strategies into the trial 
Organisation University of Exeter
Country United Kingdom 
Sector Academic/University 
PI Contribution Jane Blazeby to advise re: recruitment strategies into the trial
Collaborator Contribution Qualitative
Impact See Awards and Recognition
Start Year 2009
 
Description Arthritis Research UK - workshop on indirect comparisons for arthritis biologics 
Organisation Versus Arthritis
PI Contribution One day workshop on indirect comparisons for arthritis biologics and how best to fund future research in this area was run on 01/09/2010
Collaborator Contribution Synthesis and EVI
Impact Supplement in Rheumatology - new grant awarded for collaborators. Awarded by ARUK for £20k
Start Year 2010
 
Description Biologic Therapies in Inflammatory Joint Diseases: Models for Decision Making 
Organisation Versus Arthritis
PI Contribution Biologic Therapies in Inflammatory Joint Diseases: Models for Decision Making
Collaborator Contribution Biologic Therapies in Inflammatory Joint Diseases: Models for Decision Making
Impact Multiple publications see the relevant section and a full grant application
Start Year 2010
 
Description Biologic therapies for rheumatoid and psoriatic arthritis: consensus models for decision-making. 
Organisation Versus Arthritis
PI Contribution Wrote grant and organised the meeting
Collaborator Contribution .
Impact Full grant being written with ARUK
Start Year 2010
 
Description COMBAT 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Jelena Savovic was in charge of data collection but co-led the study. Roy Elbers (C-II) collected data while Julian Higgins, Hayley Jones, Nicky Welton (all C-II) were involved as the steering group.
Collaborator Contribution Rebecca Turner (BSU Cambridge, UCL clinical trials unit) co-led the project and supervised analysis. Kirsty Rhodes (BSU Cambridge) performed the analysis.
Impact Not known
Start Year 2010
 
Description COMBAT 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Public 
PI Contribution Jelena Savovic was in charge of data collection but co-led the study. Roy Elbers (C-II) collected data while Julian Higgins, Hayley Jones, Nicky Welton (all C-II) were involved as the steering group.
Collaborator Contribution Rebecca Turner (BSU Cambridge, UCL clinical trials unit) co-led the project and supervised analysis. Kirsty Rhodes (BSU Cambridge) performed the analysis.
Impact Not known
Start Year 2010
 
Description COMET Choice of moisturizer in eczema treatment. Alane investigator on study. 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input
Collaborator Contribution Intellectual input and conducting of research
Impact None as yet
Start Year 2013
 
Description Collaboration: DIRUM - a Database of Instruments for Resource Use Measurement 
Organisation Bangor University
Country United Kingdom 
Sector Academic/University 
PI Contribution Request for additional support to update and expand the website
Collaborator Contribution Request for additional support to update and expand the website
Impact .
Start Year 2014
 
Description Covariates in NMA 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Provide expertise on network meta-analysis
Collaborator Contribution fellowship, publications, datasets
Impact Publications in preparation
Start Year 2013
 
Description Development of a central repository of resource-use data collection instruments for trial-based economic evaluations. 
Organisation Bangor University
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-leads on this project, writing application and organising the workshops
Collaborator Contribution Co-leads writing application and organising the workshops
Impact Website, small grant and training workshop. Further funding to continue project listed in this section.
Start Year 2010
 
Description Development of a central repository of resource-use data collection instruments for trial-based economic evaluations. 
Organisation Medical Research Council (MRC)
Department MRC Midland Hub for Trials Methodology Research (MHTMR)
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-leads on this project, writing application and organising the workshops
Collaborator Contribution Co-leads writing application and organising the workshops
Impact Website, small grant and training workshop. Further funding to continue project listed in this section.
Start Year 2010
 
Description Development of core information set for oesophageal cancer 
Organisation Academic Medical Center
Country Netherlands 
Sector Academic/University 
PI Contribution Systematic review, qualitative interviews, patient Delphi survey
Impact Ongoing
Start Year 2011
 
Description ECHoES Trial 
Organisation Moorfields Eye Hospital NHS Foundation Trust
Department NIHR Moorfields Biomedical Research Centre
Country United Kingdom 
Sector Academic/University 
PI Contribution An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract) to assess the effectiveness of shared care for patients with neovascular age related macular degeneration. I devised a qualitative component as part of this proposal to determine the views of health professionals and patients on the devolving of monitoring from hospital based ophthalmologists to community based optometrists to assess the need for re-treatment.
Collaborator Contribution Collectively the partners put together an HTA proposal to assess the effectiveness of community versus hospital eye service follow-up for patients with neovascular age related macular degeneration.
Impact An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract). Multidisciplinary collaboration involving: ophthalomology, health services research, health economics, epidemiology, vision and vascular science, qualitative research
Start Year 2012
 
Description ECHoES Trial 
Organisation Queen's University Belfast
Department Centre for Experimental Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract) to assess the effectiveness of shared care for patients with neovascular age related macular degeneration. I devised a qualitative component as part of this proposal to determine the views of health professionals and patients on the devolving of monitoring from hospital based ophthalmologists to community based optometrists to assess the need for re-treatment.
Collaborator Contribution Collectively the partners put together an HTA proposal to assess the effectiveness of community versus hospital eye service follow-up for patients with neovascular age related macular degeneration.
Impact An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract). Multidisciplinary collaboration involving: ophthalomology, health services research, health economics, epidemiology, vision and vascular science, qualitative research
Start Year 2012
 
Description ECHoES Trial 
Organisation Queen's University Belfast
Department Centre for Public Health (CPH)
Country United Kingdom 
Sector Academic/University 
PI Contribution An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract) to assess the effectiveness of shared care for patients with neovascular age related macular degeneration. I devised a qualitative component as part of this proposal to determine the views of health professionals and patients on the devolving of monitoring from hospital based ophthalmologists to community based optometrists to assess the need for re-treatment.
Collaborator Contribution Collectively the partners put together an HTA proposal to assess the effectiveness of community versus hospital eye service follow-up for patients with neovascular age related macular degeneration.
Impact An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract). Multidisciplinary collaboration involving: ophthalomology, health services research, health economics, epidemiology, vision and vascular science, qualitative research
Start Year 2012
 
Description ECHoES Trial 
Organisation University of Bristol
Department School of Clinical Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract) to assess the effectiveness of shared care for patients with neovascular age related macular degeneration. I devised a qualitative component as part of this proposal to determine the views of health professionals and patients on the devolving of monitoring from hospital based ophthalmologists to community based optometrists to assess the need for re-treatment.
Collaborator Contribution Collectively the partners put together an HTA proposal to assess the effectiveness of community versus hospital eye service follow-up for patients with neovascular age related macular degeneration.
Impact An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract). Multidisciplinary collaboration involving: ophthalomology, health services research, health economics, epidemiology, vision and vascular science, qualitative research
Start Year 2012
 
Description ECHoES Trial 
Organisation University of Liverpool
Department Department of Eye and Vision Science
Country United Kingdom 
Sector Academic/University 
PI Contribution An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract) to assess the effectiveness of shared care for patients with neovascular age related macular degeneration. I devised a qualitative component as part of this proposal to determine the views of health professionals and patients on the devolving of monitoring from hospital based ophthalmologists to community based optometrists to assess the need for re-treatment.
Collaborator Contribution Collectively the partners put together an HTA proposal to assess the effectiveness of community versus hospital eye service follow-up for patients with neovascular age related macular degeneration.
Impact An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract). Multidisciplinary collaboration involving: ophthalomology, health services research, health economics, epidemiology, vision and vascular science, qualitative research
Start Year 2012
 
Description ECHoES Trial 
Organisation University of Oxford
Department Health Economics Research Centre
Country United Kingdom 
Sector Academic/University 
PI Contribution An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract) to assess the effectiveness of shared care for patients with neovascular age related macular degeneration. I devised a qualitative component as part of this proposal to determine the views of health professionals and patients on the devolving of monitoring from hospital based ophthalmologists to community based optometrists to assess the need for re-treatment.
Collaborator Contribution Collectively the partners put together an HTA proposal to assess the effectiveness of community versus hospital eye service follow-up for patients with neovascular age related macular degeneration.
Impact An NiHR HTA Programme Clinical Evaluation and Trials proposal has been accepted for funding (subject to cost revisions and contract). Multidisciplinary collaboration involving: ophthalomology, health services research, health economics, epidemiology, vision and vascular science, qualitative research
Start Year 2012
 
Description HTA - surgical trial UKKUFF 
Organisation National Institute for Health Research
Department Health Technology Assessment Programme (HTA)
Country United Kingdom 
Sector Public 
PI Contribution Jane Blazeby now chairs the trial steering committee for a difficult surgical trial UKKUFF.
Collaborator Contribution Educational
Impact See Awards and Recognition
Start Year 2010
 
Description HTMR Recruitment to Trials Working Group membership 
Organisation Medical Research Council (MRC)
Department Network of Hubs for Trials Methodology Research (HTMR)
Country United Kingdom 
Sector Academic/University 
PI Contribution collaborative work to identify priority areas to improve trial recruitment - involvement includes contribution to discussions, research dissemination and workshop design and delivery
Collaborator Contribution collaborative work to identify priority areas to improve trial recruitment - involvement includes contribution to discussions, research dissemination and workshop design and delivery (as above as this is collaborative work). Funding for workshops.
Impact Outcomes: Two workshops funded and run; "Developing, delivering and evaluating training courses for recruiters to randomised trials" and two-day workshop on "the design and analysis of clinical trials in head and neck cancer". Educational impact. Multidisciplinary: health services research, clinical, academic, quantitative research, qualitative research
Start Year 2011
 
Description Health Economics and Population Health: Emerging Methodological and Policy Issues for the Health Economics Community 
Organisation Cardiff University
Country United Kingdom 
Sector Academic/University 
PI Contribution The fourth annual UKCRC Public Health Research Centres of Excellence (PHRCoE) Conference took place in Cardiff on Tuesday 9 and Wednesday 10 July 2013
Collaborator Contribution NA
Impact NA
Start Year 2013
 
Description LopeRA Trial 
Organisation Institute of Cancer Research UK
Country United Kingdom 
Sector Academic/University 
PI Contribution Jane Blazeby now Chairs the trial steering committee
Collaborator Contribution Feasibility studies
Impact See Awards and recognition
Start Year 2010
 
Description MRC MRP losing the losses: understanding the reasons for attrition in RCTs and developing the evidence to prevent it. 
Organisation Queen's University Belfast
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input, writing of qualitative study plan and conducting of research
Collaborator Contribution Liverpool provided the sampling frame for the qualitative element in order for both quantitative and qualitative elements to fully marry when reporting the results. We continue to involve them with regular updates and conference calls.
Impact None known as yet
Start Year 2013
 
Description MRC MRP losing the losses: understanding the reasons for attrition in RCTs and developing the evidence to prevent it. 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input, writing of qualitative study plan and conducting of research
Collaborator Contribution Liverpool provided the sampling frame for the qualitative element in order for both quantitative and qualitative elements to fully marry when reporting the results. We continue to involve them with regular updates and conference calls.
Impact None known as yet
Start Year 2013
 
Description MRC PHRN working group writing guidelines for process evaluation within randomised controlled trials of complex public health interventions 
Organisation University of Bristol
Department MRC PHRN Working Group
Country United Kingdom 
Sector Academic/University 
PI Contribution Dr Suzanne Audrey is a member of the MRC PHRN working group writing guidelines for process evaluation within randomised controlled trials of complex public health interventions
Collaborator Contribution NA
Impact NA
Start Year 2013
 
Description Methodology and development of Core Outcome Sets / Core Information Sets 
Organisation European Commission
Department Seventh Framework Programme (FP7)
Country European Union (EU) 
Sector Public 
PI Contribution Contributed to workshop facilitation, presentation at COMET PPI workshop, teleconferences discussion about optimal methodology
Collaborator Contribution Guidance on methodology, generated and facilitated workshops, sharing of expertise
Impact Presentation at COMET PPI workshop Presentation and help with facilitation of COMET methodological workshop Multi-disciplinary: statisticians, trial methodologists, health professionals
Start Year 2012
 
Description Qualitative research advisers to CONSORT Pilot and Feasibility Study Reporting Guideline Group 
Organisation McMaster University
Country Canada 
Sector Academic/University 
PI Contribution Hoddinott and O'Cathain attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies.
Collaborator Contribution Attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies - collaboratively with our team members.
Impact Paper planned. Multidisciplinary: collaboration between health service statisticians and methodologists.
Start Year 2014
 
Description Qualitative research advisers to CONSORT Pilot and Feasibility Study Reporting Guideline Group 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Hoddinott and O'Cathain attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies.
Collaborator Contribution Attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies - collaboratively with our team members.
Impact Paper planned. Multidisciplinary: collaboration between health service statisticians and methodologists.
Start Year 2014
 
Description Qualitative research advisers to CONSORT Pilot and Feasibility Study Reporting Guideline Group 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution Hoddinott and O'Cathain attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies.
Collaborator Contribution Attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies - collaboratively with our team members.
Impact Paper planned. Multidisciplinary: collaboration between health service statisticians and methodologists.
Start Year 2014
 
Description Qualitative research advisers to CONSORT Pilot and Feasibility Study Reporting Guideline Group 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Hoddinott and O'Cathain attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies.
Collaborator Contribution Attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies - collaboratively with our team members.
Impact Paper planned. Multidisciplinary: collaboration between health service statisticians and methodologists.
Start Year 2014
 
Description Qualitative research advisers to CONSORT Pilot and Feasibility Study Reporting Guideline Group 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Hoddinott and O'Cathain attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies.
Collaborator Contribution Attended a meeting in February 2014 (invitation only) and a 2 day international meeting in October 2014; these meetings enabled members to reach a consensus on guidelines for reporting qualitative research in feasibility and pilot studies - collaboratively with our team members.
Impact Paper planned. Multidisciplinary: collaboration between health service statisticians and methodologists.
Start Year 2014
 
Description Qualitative study: conversation analysis to study therapist-patient interactions during online CBT 
Organisation Peninsula College of Medicine & Dentistry
Country United Kingdom 
Sector Academic/University 
PI Contribution Successful proposal submitted to BUPA Foundation for a collaboration on a qualitative study using conversation analysis to study therapist-patient interactions during online CBT, as part of a trial of online CBT for depression.
Collaborator Contribution Qualitative
Impact See Awards and Recognition.
Start Year 2010
 
Description Recruitment to trials methodology network working group 
Organisation Medical Research Council (MRC)
Department MRC North West Hub for Trials Methodology Research
Country United Kingdom 
Sector Public 
PI Contribution Nicola Mills leads the working group, others contribute
Collaborator Contribution Contributed to all outputs to date
Impact Document on "Tips for optimising recruitment of patients to randomised clinical trials"; national cross hub workshop on recruitment into surgical trials; national cross hub workshop on the value of integrating qualitative research in randomised trials; session on trial recruitment at the National HTMR annual meeting; preparation for a forthcoming national cross hub workshop with clinical trial unit directors on recruitment and retention in randomised trials.
Start Year 2011
 
Description Recruitment to trials methodology network working group 
Organisation Queen's University Belfast
Department The All-Ireland Hub for Trials Methodology Research
Country United Kingdom 
Sector Academic/University 
PI Contribution Nicola Mills leads the working group, others contribute
Collaborator Contribution Contributed to all outputs to date
Impact Document on "Tips for optimising recruitment of patients to randomised clinical trials"; national cross hub workshop on recruitment into surgical trials; national cross hub workshop on the value of integrating qualitative research in randomised trials; session on trial recruitment at the National HTMR annual meeting; preparation for a forthcoming national cross hub workshop with clinical trial unit directors on recruitment and retention in randomised trials.
Start Year 2011
 
Description Recruitment to trials methodology network working group 
Organisation University of Edinburgh
Department Edinburgh Hub for Trials Methodology Research
Country United Kingdom 
Sector Academic/University 
PI Contribution Nicola Mills leads the working group, others contribute
Collaborator Contribution Contributed to all outputs to date
Impact Document on "Tips for optimising recruitment of patients to randomised clinical trials"; national cross hub workshop on recruitment into surgical trials; national cross hub workshop on the value of integrating qualitative research in randomised trials; session on trial recruitment at the National HTMR annual meeting; preparation for a forthcoming national cross hub workshop with clinical trial unit directors on recruitment and retention in randomised trials.
Start Year 2011
 
Description SMILE feasiblilty and main trial 
Organisation University of Bristol
Department School of Social and Community Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution One colleague from the qualitative research theme provides overall advice and another supervised the research associate undertaking the qualitative work and sits on the steering group committee.
Collaborator Contribution Both colleagues are co-applicants on the SMILE feasibility and main trial proposal (proposal funded Sept 2010-ongoing)
Impact Collaboration led to successful grant application - SMILE feasibility study - which then led to the main trial being funded
Start Year 2010
 
Description Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool 
Organisation Bangor University
Country United Kingdom 
Sector Academic/University 
PI Contribution Leading on systematic review
Collaborator Contribution Leading on extension of database to cover international instruments
Impact .
Start Year 2012
 
Description Systematic review of methods to improve resource use measurement in economic evaluations alongside randomised trials, and a contextual review of use of instruments: Utilising DIRUM as a research tool 
Organisation Medical Research Council (MRC)
Department MRC Midland Hub for Trials Methodology Research (MHTMR)
Country United Kingdom 
Sector Academic/University 
PI Contribution Leading on systematic review
Collaborator Contribution Leading on extension of database to cover international instruments
Impact .
Start Year 2012
 
Description TOGA Trial Steering Committee independent membership 
Organisation BUPA
Department BUPA Foundation
Country United Kingdom 
Sector Private 
PI Contribution Independent member of the Trial Steering Committee (with a role relating to qualitative methods within trials) for the TOGA trial
Collaborator Contribution Cardiff University is the sponsor and Bupa Foundation is the funder.
Impact Not yet known Multidisciplinary
Start Year 2012
 
Description TOGA Trial Steering Committee independent membership 
Organisation Cardiff University
Country United Kingdom 
Sector Academic/University 
PI Contribution Independent member of the Trial Steering Committee (with a role relating to qualitative methods within trials) for the TOGA trial
Collaborator Contribution Cardiff University is the sponsor and Bupa Foundation is the funder.
Impact Not yet known Multidisciplinary
Start Year 2012
 
Description The Rosetrees and the RCS Clinical Trials Initiative: Surgical Specialty Lead in UGI Surgery for Trials, J Blazeby 
Organisation Royal College of Surgeons of England
Country United Kingdom 
Sector Learned Society 
PI Contribution Surgical Specialty Lead in Upper GI Surgery for Trials, which involves developing new trials, establishing networks, and working with patients to deliver innovative trials.
Collaborator Contribution Remit is the same for the other surgical leads and networks in the group which covers: orthopaedics, otolaryngology, transplantation, neurosurgery, cardiothoracic surgery, head and neck, coloproctology, endocrine surgery, surgery and plastics and hand surgery.
Impact Not known.
Start Year 2012
 
Description The use of ICECAP measures in clinical trials and economic evaluation 
Organisation Medical Research Council (MRC)
Department MRC Midland Hub for Trials Methodology Research (MHTMR)
Country United Kingdom 
Sector Academic/University 
PI Contribution The use of ICECAP measures in clinical trials and economic evaluation
Impact Workshops and a website developed
Start Year 2010
 
Description Trial Steering Committee for the TOGA trial - Ali Heawood 
Organisation Cardiff University
Country United Kingdom 
Sector Academic/University 
PI Contribution Dr Ali Heawood is an independent member of qualitative theme - with a role relating to qualitative methods within trials
Collaborator Contribution NA
Impact NA
Start Year 2012
 
Description 'Recruitment into RCTs and the pilot & feasibility studies' and 'Large scale pragmatic RCTs in surgery and the Bristol Surgical Trials Centre 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Blazeby JM Invited talk at Tomorrow's Leaders - Clinical Trials in Surgical Oncology, Royal College of Surgeons of England, London
Year(s) Of Engagement Activity 2015
 
Description 10/01/14 - JB - Independent Trial Steering Committee talk 'Team work and communication in robotic surgery' - funded by NHS R&D. Hosted at Leeds University 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Shared information and sparked conversation and plans

No specific impacts
Year(s) Of Engagement Activity 2014
 
Description 3. Hirst A, Cook J, McCulloch P, Altman DG, Heneghan C, Deiner MK, Ergina PL, Barkun J, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A. Tailoring study design to each stage of surgical innovation: the IDEAL recommendations. 2nd Clinical Trials Methodo 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presentation with questions.

None known
Year(s) Of Engagement Activity 2013
URL http://www.trialsjournal.com/supplements/14/S1
 
Description 4. Blencowe N, Boddy A, Harris A, Hanna T, Whiting P, Cook J, Blazeby J. Accounting for intervention complexity in RCTs in surgery: new surgical approaches for intervention definition and methods for monitoring fidelity. 2ndClinical Trials Methodology Con 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presentation with questions.

None known
Year(s) Of Engagement Activity 2013
URL http://www.trialsjournal.com/supplements/14/S1
 
Description Adaptive approaches to randomised trials of non-pharmaceutical interventions. MRC Hubs for Trials Methodology Research, Adaptive Designs Research Workshop, Cambridge 27-28 January 2014. C Metcalfe 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Conference delegates attended the presentation and asked questions.

none known
Year(s) Of Engagement Activity 2014
URL http://www.mrc-bsu.cam.ac.uk/mrc-hub-networks-adaptive-designs-for-clinical-trials-workshop/
 
Description BBC News online - article re: surgical trials (By-Band) 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Unknown
Year(s) Of Engagement Activity 2013
URL http://www.bbc.co.uk/news/health-24388537
 
Description Best-practice for patient reported outcomes (PROs) - Institute of Advanced Studies, University of Birmingham, July 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Workshop led by Jane Blazeby & Mel Calvert

NOT KNOWN
Year(s) Of Engagement Activity 2013
 
Description COMET Public and Patient Involvement Workshop (one-day workshop, presentation and group discussions) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Presentation and group discussions attended by approximately 30 researchers, patient and patient group representatives - identified potential ways to better engage the public.

Not aware of any.
Year(s) Of Engagement Activity 2014
 
Description Clear obstacles and hidden challenges to recruitment in the OPTIMA and other trials. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Other audiences
Results and Impact Donovan JL Invited talk at Scottish Clinical Trials in Breast Cancer Annual Meeting, Edinburgh. 26/02/2015
Year(s) Of Engagement Activity 2015
 
Description ConDuCT Talk (BOMMS) - 'Outcomes in bariatric surgery' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Talk on 'Outcomes in bariatric surgery' at British Obesity and Metabolic Surgery Society Annual Scientific Meeting, which sparked audience questions and discussion.

Discussion and promotion of thinking around the measurement of outcomes in bariatric surgery.
Year(s) Of Engagement Activity 2014
 
Description ConDuCT talk at RCSE (with their Research Fellowship Scheme) 'Getting started in Surgical Research' J, Blazeby 13/11/13 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Information shared, questions addressed.

None known.
Year(s) Of Engagement Activity 2013,2014
 
Description Contribution to a radio documentary 'Is surgery scientific?' discussing the challenges of submitting surgery to the same types of randomised controlled trials as other forms of medical interventions. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact n/a
Year(s) Of Engagement Activity 2011
 
Description Core outcomes sets in cancer trials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact n/a
Year(s) Of Engagement Activity 2011
 
Description Core outcomes sets to improve trial conduct 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact N/A
Year(s) Of Engagement Activity 2010
 
Description Course - "How qualitative methods can contribute to the design and conduct of randomised trials - A University of Bristol School of Social and Community Medicine course in conjunction with ConDuCT Hub 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Mills N, Heawood A, Donovan J. Organised and ran the course "How qualitative methods can contribute to the design and conduct of randomised trials - A University of Bristol School of Social and Community Medicine course in conjunction with ConDuCT Hub (18 June 2013). (Tutors in addition to the above include S Paramsivan, S Audrey)

Educational outcome and impact at present
Year(s) Of Engagement Activity 2013
 
Description Course presenter - Workshop: Mixed Treatment Comparisons & Value of Information methods for Health Technology Assessment 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Educational impact only at present
Year(s) Of Engagement Activity 2010
 
Description Developing, delivering and evaluating training courses for recruiters to randomised trials. Funded by MRC HTMR. 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Mills N, Donovan JL, Young B, Bower P, Gamble C, Tudur-Smith C, Holding P, Blazeby J. Workshop, University of Bristol. 03/2014 - 08/2015
Year(s) Of Engagement Activity 2014,2015
 
Description Existing evidence in emergency non-trauma general surgery: An overview of systematic review. Poster presentation. Association of Surgeons of Great Britain and Ireland - ASGBI 2014. N. Howes, J. Savovic, N. Blencowe, J. Blazeby 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact increased understanding re lack of evidence in emergency surgery

Nothing specific known to date
Year(s) Of Engagement Activity 2014
URL http://www.asgbi.org/harrogate2014/?CFID=2726&CFTOKEN=EBA4E7FF-6C59-4011-AB1EA780B91B8876
 
Description Health Economists Study Group Warwick June 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Edwards R.T., Lloyd-Williams H., Charles J.M., McIntosh E., Craig N., Hollingworth W., Lawson, K., and Donaldson C.Health Economics and Population Health: Emerging Methodological and Policy Issues for the Health Economics Community, Health Economists Study Group Warwick June 2013 - oral presentation

NOT RECORDED
Year(s) Of Engagement Activity 2013
 
Description Health Economists Study Group, Warwick, June 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Hollinghurst S, Banks J, Bigwood L, Walters F, Hamilton W, Peters T. Using willingness-to-pay to establish patient preferences for cancer testing in primary care. Health Economists Study Group, Warwick, Jun 2013 - oral presentation

NOT RECORDED
Year(s) Of Engagement Activity 2013
 
Description MCRN Methodology CSG meeting, Manchester 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Clinicians, academic and the public attended the workshop on recruitment to paediatric trials and this sparked conversation afterwards regarding trial recruitment.

Educational impact, not assessed - possible improvements in informed consent and recruitment to trials.
Year(s) Of Engagement Activity 2013
 
Description MRC Joint Stroke Research Network Outcomes workshop 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Key note speaker and group discussions at a one-day workshop: Attended by approximately 30 individuals including trial methodologists, statisticians, consultants, nurses and patient representatives - informed practitioners about relevant methodological work and highlighted current issues in outcomes research .

Not aware of any
Year(s) Of Engagement Activity 2014
 
Description MRC Joint Stroke Research Network Outcomes workshop 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Key note speaker and group discussions at a one-day workshop: to share information, identify research agenda, stimulate thinking and enhance collaboration. Attended by approximately 30 individuals including trial methodologists, statisticians, consultants, nurses and patient representatives - informed practitioners about relevant methodological work and highlighted current issues in outcomes research. Groundwork laid for future potential collaboration.

Not aware of any
Year(s) Of Engagement Activity 2014
 
Description Methods to determine what to measure - COMET III Conference, Manchester, 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact COMET III Conference, Manchester, 2013 - workshop led by Jane Blazeby & Paula Williamson

NOT KNOWN
Year(s) Of Engagement Activity 2013
 
Description Mixed methods approaches to understanding trial outcomes; Nursing Midwifery and Health Professionals Workshop. 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other audiences
Results and Impact Hoddinott P Workshop. University of Stirling
Year(s) Of Engagement Activity 2014
 
Description Optimising recruitment into RCTs in surgery: a focused workshop for surgeons 24.03.15 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact MRC ConDuCT-II Hub in collaboration with the North West HTMR, workshop at University of Bristol. 24.03.17
Year(s) Of Engagement Activity 2015
 
Description Oral presentation at the South West Society for Academic Primary Care conference, Bristol 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presentation on qualitative study of group decision making and member roles to understand and improve how Trial Oversight Committees contribute to trial conduct - generated discussion around Trial Oversight Committees.

Networking, educational outcome.
Year(s) Of Engagement Activity 2014
 
Description Overcoming barriers to recruitment in trials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact NOT KNOWN
Year(s) Of Engagement Activity 2013
 
Description Patient consensus meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact Patients with colorectal cancer and their relatives attended discussions of which outcomes should be measured in all trials in colorectal cancer surgery

Finalised the patient colorectal core outcome set (yet to be published)
Year(s) Of Engagement Activity 2013
 
Description Pragmatic trials and the need for evidence for surgical practice 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Jane Blazeby invited talk at Swedish Surgical Week in Karlstad Sweden, August 2014
Year(s) Of Engagement Activity 2014
 
Description Presentation - ProDiet, 32nd Congress of the Societe Internationale d'Urologie (Oct 2012) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Health professionals
Results and Impact Oral presentation (A Lane) ProDiet: the feasibility of a randomised controlled trial of dietary interventions for men at elevated risk of prostate cancer. (Prostate Cancer: Therapy session)
32nd Congress of the Societe Internationale d'Urologie, Fukuoka, Japan, Oct 2012

Raised awareness of study
Year(s) Of Engagement Activity 2012
 
Description Presentation at NICE Away Day 2013: 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Made NICE Committee members and Evidence Review Groups aware of the potential for the use of external information to better inform the shape of survival curves, to help make better reimbursement decisions

The survival curve reconstruction methods have been used in submissions to NICE technology appraisals. The committee members have an improved understanding of the key issues in extrapolating beyond trial follow-up periods
Year(s) Of Engagement Activity 2013
 
Description Presentation at the European Society of Esophagology (Newcastle Nov 2011) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Health professionals
Results and Impact Jane Blazeby gave a presentation to 60+ surgeons on core infomation for oesophageal cancer patients with interactive voting

Wide interest from the audience and questions/debate - following the meeting there were 20+ healthcare professionals who became participants in the Delphi consensus project
Year(s) Of Engagement Activity 2011
 
Description Presentation at the NIHR Applied Health Research in Surgery workshop 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Health professionals
Results and Impact Presentation titled 'Challenges and opportunities in Surgical Research' at the Royal College of Surgeons, London, on 9 February 2012. The workshop attracted over 275 delegates, from a range of surgical disciplines and backgrounds.

Video of presentation available on You Tube with high number of views
Year(s) Of Engagement Activity 2012
 
Description Presentation: the UK700 trial of psychiatric case management 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Educational impact only at present
Year(s) Of Engagement Activity 2009
 
Description Recruitment challenges in surgical RCTs 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Blazeby JM Invited talk - Key note speech at Swedish Surgical week, Karlstad (Sweden), August 14
Year(s) Of Engagement Activity 2014
 
Description Recruitment training workshop for Clinical Research Network medics 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Mills N, Donovan JL, Elliott D, Jepson M, Rooshenas L, Workshop. University of Bristol/CRN. 13.06.17
Year(s) Of Engagement Activity 2016
 
Description Recruitment training workshop for Clinical Research Network nurses 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Mills N, Donovan JL, Elliott D, Jepson M, Workshop at University of Bristol/CRN. 21.03.16
Year(s) Of Engagement Activity 2016
 
Description Series of presentations comprising Short course, School of Social and Community Medicine, UoB 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Series of talks/presentations, by several members of the team, comprising "Qualitative Research in randomised trials" one-day short-course. Generated discussion around the contribution of qualitative research to the design and conduct of randomised trials.

Excellent feedback from attendees and continuation short course for the next year.
Year(s) Of Engagement Activity 2014
URL http://www.bristol.ac.uk/social-community-medicine/shortcourse/scqualres.html
 
Description South-West SAPC, Mar 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Hollinghurst S, Banks J, Peters T, Bigwood L, Walters F, Hamilton W. Patient views on being referred for diagnostic testing for cancer: a vignette based survey - oral presentation

NOT RECORDED
Year(s) Of Engagement Activity 2013
 
Description Talk (International Hepato-Pancreato Biliary Association) 'Evaluating Cancer Surgery: the need for consistency, consensus and core outcome sets' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Talk at International Hepato-Pancreato Biliary Association to share information and promote thinking, which initiated questions

Audience discussion promoting thinking about research in area.
Year(s) Of Engagement Activity 2014
 
Description Talk (NCRI) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Talk at NCRI Annual Meeting, Liverpool - 'Smarter surgery for better outcomes', to promote thinking, and which led to questions and discussion

Discussion about research into surgery with audience.
Year(s) Of Engagement Activity 2013
 
Description Talk at North West Clinical Trialists meeting at Manchester University 'How to design feasibility studies - definitions and roles' (RCTs in surgery) 4/11/13 - JB 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Talk with questions.

none known
Year(s) Of Engagement Activity 2013
 
Description Talk at Oesophageal Patient Association (Birmingham Nov 2011) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Jane Blazeby invited to talk to 30+ attendees at a patient support group to discuss core information for oesphageal patients with interactive voting

Attendees very enagaged in the development of a core outcome set. 20+ went on to participate in the Delphi consensus project
Year(s) Of Engagement Activity 2011
 
Description Talk entitled "Mixed methods approaches to understanding trial outcomes at Nursing Midwifery and Health Professionals Workshop 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Postgraduate students
Results and Impact PG students and other academics attended the talk and interactive discussion session: generated discussion around novel ways of applying qualitative methods to trials, and resulted in suggestions for different approaches to applying qualitative research to trials.

suggestions made for different approaches to applying qualitative research to trials.
Increase in requests for further information AND further participation/involvement.
Year(s) Of Engagement Activity 2014
 
Description The Bluebelle Study: a feasibility study of complex, simple and absent wound dressings in elective surgery. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Jane Blazeby, invited talk at Tissue Viability Society meeting 2014. York April 2014
Year(s) Of Engagement Activity 2014,2016
 
Description The Bluebelle study - 'designing trials of relevance to patients, clinicians and the NHS' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Blazeby JM Invited talk at UHB Research and Innovation Day, Bristol 04.12.15
Year(s) Of Engagement Activity 2015
 
Description University of Bristol Population Health Annual Symposium - 14th November 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Taylor HJ, Davis MJ, Down EA, Macefield RC, Holding PN, Donovan JL , Hamdy FC, Neal DE, Lane JA. Evaluation of source data verification in a cancer multicentre trial (Protect). University of Bristol Population Health Annual Symposium - 14th November 2013, Bristol - Poster

NOT RECORDED
Year(s) Of Engagement Activity 2013
 
Description Webinar: Survival Analysis: the parallel universes of efficacy and cost-effectiveness analysis 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Educational impact only at present
Year(s) Of Engagement Activity 2010
 
Description Western Comprehensive Local Research Network Surgery Specialty Group Research Day, 3rd June 2013, Bristol 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Blazeby JM. Challenges with surgical research: methodological issues. Western Comprehensive Local Research Network Surgery Specialty Group Research Day, 3rd June 2013, Bristol - talk

NOT RECORDED
Year(s) Of Engagement Activity 2013
 
Description Workshop (Internal Pilot Trials). Funded by a MRC Hubs for Trials Methodology Research Network Grant (started October 2013), K Avery 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 25 peers/collaborators/experts in the field attended a workshop to discuss current evidence and share knowledge about optimising internal pilot trials to inform more efficient randomised controlled trials. This informed recommendations for the design and conduct of internal pilot trials, which is being written up for submission to a peer-reviewed journal.


Submission to a peer-reviewed journal (due early 2015).
Year(s) Of Engagement Activity 2014
 
Description Workshop for clinicians and recruiters to head and neck cancer trials, Liverpool 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Workshop sparked conversation about trial recruitment

Educational impact - not assessed. Possible improvements in informed consent and recruitment to trials.
Year(s) Of Engagement Activity 2013
 
Description talk 'Pragmatic versus explanatory trials in head and neck surgery' - NW hub Surgical Training Day 9/12/13 - JB 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Presentation with discussion

None known
Year(s) Of Engagement Activity 2013