CCT7 Methodological Innovation

This theme focuses on developing research methods of particular relevance to the nature and context of primary and emergency care research. This will include entirely novel approaches and approaches used in other settings that we will adapt and evaluate for use in PRIME Centre Wales research. 


Ruth Lewis, Bangor University
Professor Kerry Hood, Cardiff University

In the year April 2016 to March 2017, there have been five papers published with methodological innovations, two methodological presentations in national and international conferences and eight research projects completed or in progress, and one doctoral fellowship.

Use of routinely collected data

  • Formalised links with SAIL Databank - Ashra Khanom has taken on the role of providing a link between PRIME researchers and the SAIL database, to support the development of new research proposals. We continue to expand our interest in the use of anonymised routine linked data to explore feasibility, effectiveness and impact of interventions and to support improvements to service delivery. We are also examining the role of linked data through other approaches, e.g. the direct linking of ambulance service and acute trust datasets in the SAIL project.
  • P2P Solva Care feasibility study led by Bridie Evans is methodologically innovative on two aspects: linked data; collaborative approach to undertaking the research in partnership with a community group.
  • Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) developed a community-based rehabilitation intervention following hip fracture in the frail elderly, which was tested in a randomised feasibility study. This included a triangulation study comparing health service activity data from participant self-report, collected in the patient completed questionnaire, with routinely collected electronic data from secondary, community and primary care sectors.

Obtaining informed consent from vulnerable adults

  • Informed consent and proxy decision making in research involving adults lacking capacity development of an intervention to support proxy informed decision making, set within ethical and legal frameworks. This is a NIHR Doctoral Fellowship Award led by Victoria Shepherd, supervised by Kerry Hood and Fiona Wood. The aim of this project is to develop a tool to support informed decision making for adults lacking decision-making capacity to take part in research. This will be achieved through: exploring the ethical and legal factors involved; deciding what factors and information must be included in the support tool; and developing a support tool that is suitable to be used by families and friends when making decisions for adults lacking capacity.
  • Network exploring Ethics of Ambulance Trials (NEAT) aims to develop a network exploring the ethics of conducting randomised controlled trials (RCTs) involving ambulance services. A systematic review will compare legal and ethical requirements for gaining consent in emergency settings in the UK, mainland Europe, US and Australia. Qualitative studies with patients and ambulance staff will explore the ethical issues in undertaking research, particularly trials, in emergency prehospital ambulance care.  These are mostly around challenges in gaining consent; including patients without capacity (unconscious, dementia, or simply traumatised); and carrying out different types of studies e.g. cluster trials, and anonymised linked data follow up. Networking events with researchers, ambulance leaders, policymakers and ethicists will discuss findings and develop preliminary recommendations for best practice.

Behaviour change

  • Training workshop on applying the Behaviour Change Wheel – Stephanie Smits provided training on using the Behaviour Change Wheel to develop a primary care intervention to expedite the diagnosis of symptomatic cancer, for the Wales Intervention and Cancer Knowledge about Early Diagnosis (WICKED) study.
  • Assessing fidelity to Motivational Interviewing in Public Health Interventions (MI-PHI). Nina Gobat and colleagues have developed a reliable measure of "focusing" in Motivation Interviewing, with a paper on development and initial reliability in development. Further validation planned in next stage grant application. The overall aim is to develop a process evaluation method of MI fidelity, by reliably assessing when and how clinicians establish a behavioural focus against which to strategically elicit and reinforce change talk.

Qualitative research

  • STAR Family Study is using novel participative methods in narrative interviews with women who have rheumatic diseases, to facilitate them in telling their story. This includes the provision of resources to create a timeline, draw, write, and/or create a collage prior to the interview, which they can then use as a guide in talking to the interviewer about their experiences.

Efficient systematic review design

  • Methods for the assessment of the effectiveness of treatment sequences for clinical and economic decision making in the NHS (NIHR fellowship) aims to inform a framework for conducting quantitative evidence synthesis of the effectiveness of sequential treatment options in the context of decision analysis. The work includes a comprehensive methodological review of the literature to identify quantitative evidence synthesis methods that have been developed to estimate the treatment effect of interventions conditional on position in a treatment sequence.


  • Mark Kingston (oral): Introducing the PRIDaL model - a Process for Routine and Identifiable Data Linkage at the International Population Data Linkage Conference 2016.
  • Alison Porter (poster): Data Linkage across ambulance services and acute trusts: assessing the potential for improving patient care at the HSRUK Symposium, July 2016 and International Population Data Linkage Conference 2016. 


Site visits to initiate recruitment in a clinical trial: does it matter who conducts the visit? Protocol for implementation in trials. C Nollett, M Kelson, K Hood. Journal of Evidence Based-Medicine. DOI: 10.1111/jebm.12212

Ethnographic methods for process evaluations of complex health behaviour interventions. Morgan Trimmer S and Wood F. Trials 2016 DOI: 10.1186/s13063-016-1340-2

Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture.
Williams NH, Roberts JL, Din NU, et al. BMJ Open 2016;6:e012422. doi: 10.1136/bmjopen-2016-012422

The use of randomisation-based efficacy estimators in non-inferiority trials.
Gillespie D, Hood K, Farewell D, Hawthorne A, Probert C, Stenson R, Barrett-Lee P, Casbard C, Murray N. Trials 2015, 16 (Suppl 2):P129.

Mixed-methods study to develop a patient complexity assessment instrument for district nurses. Thomas S, Wallace C, Jarvis P, Davis R. Nurse Res. 2016 Mar;23(4):9-13. doi: 10.7748/nr.23.4.9.s3.

Motivational interviewing competencies among UK family nurse partnership nurses: a process evaluation component of the building blocks trial. Channon S, Bekkers MJ, Sanders J, Cannings-John R, Robertson L, Bennert K, Butler C, Hood K, Robling M. BMC Nurs. 2016 Sep 20;15:55. doi: 10.1186/s12912-016-0176-0. eCollection 2016.

Examiner reliability in fluorosis scoring: a comparison of photographic and clinical methods. Mohd Nor NA, Chestnuttl IG, Chadwick BL. Community Dent Health. 2016 Jun;33(2):145-50.

Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice. Shepherd V, Nuttall J, Hood K, Butler CC. BMC Res Notes. 2015 Jul 16;8:306. doi: 10.1186/s13104-015-1276-8.