ConDuCT-II Hub. Collaboration and innovation for difficult and complex randomised controlled trials in invasive procedures. Theme 2: integrative and dynamic research methods to optimise recruitment for RCTs. (Phase II)

Aim(s):

To develop and implement research methods that will lead to marked improvements in the successful prioritisation, design, conduct and completion of RCTs.

Summary:

The ConDuCT Hub was established in April 2009 based at the University of Bristol is part of an established environment and infrastructure to ensure continued close collaboration with other MRC Hubs for Trials Methodology Research (HTMRs), UKCRC-registered Clinical Trials Units (CTUs) and other relevant groups which focus on improving the conduct of RCTs.

The CONDUCT II Hub funding focuses on four themes:

  • Theme 1: Prioritisation and design of trials for cost effectiveness analysis
  • Theme 2: Integrative and dynamic research methods to optimise recruitment to RCTs
  • Theme 3: Trial conduct and feasibility study design
  • Theme 4: Trial outcomes: selection, reporting and integration into decision-making

Pat Hoddinott is one of three external co-applicants on this University of Bristol research methods hub project and contributes mainly to Themes 2 and 3.

Outcomes/Impact:

The CONDUCT II hub has met pre-specified objectives and performance metrics in the MRC funding application.  These are numerous and many are available on the Hub website http://www.bristol.ac.uk/social-community-medicine/centres/conduct2/

The impact for NMAHP-RU has been a raised profile for the trials methodology work undertaken by the unit amongst the trial methodology community.  Through this collaboration, the Unit’s Pat Hoddinott and Edward Duncan are co-applicants on the MRC funded INDEX study [M01.2], Pat is a co-applicant on a MRC funded study to develop guidance to optimise pilot study design and conduct [M01.4] which follows Pat’s provision of qualitative methods input into the CONSORT guidance extension for pilot and feasibility trials (see below).   Pat is also a collaborator on a MRC funded small grant to develop a medical work force that designs, participates in, and implements findings of trials to improve evidence based practice. This is a case study in surgery, with the intention of in future extending the learning to the primary care workforce and beyond. The Unit’s Brian Williams was invited by Prof Jane Blazeby to deliver a keynote talk at the Royal College of Surgeons in 2014.  The MRC Hub Collaboration has enhanced Pat’s reputation in the field of Pilot and feasibility studies, and as a result she was invited to be Guest Editor of a special series on intervention development in Pilot and Feasibility Studies, a sister journal of Trials.

Principal Investigator: University of Bristol

NMAHP Research Unit Collaborators: Professor Pat Hoddinott

External Collaborators: Hollingsworth W, Donovan J, Brookes ST, Welton N, Lane A, Higgins J, Noble S, Hollinghurst S, Metcalfe C, Sterne J, Thom J, Campbell R, Tilling K, O’Cathain A, Heawood A, Mills N, Montgomery AA, Peters T, Wiles N, Macefield R, Rogers C, Cook JA, Huxtable R, Avery K, Savovic J, Salisbury C

Funder: Medical Research Council