1. Introduction to the unit and mixed methods approaches to research Kerry Hood

2. Background Funded as part of CRC Cymru Builds on a core team of trialists Predominantly working in primary care Developing and evaluating complex interventions Core funding provides the infrastructure to Develop high quality studies Have the structure to conduct studies to the highest quality

3. Aims To improve the number and quality of trials in health and social care led by Welsh investigators To coordinate multi-centre trials across Wales, the UK and beyond To develop portfolios of expertise which are recognised both nationally and internationally To enhance collaborative working within CRC Cymru and UK CRC

5. Key points to note Definition of a Clinical Trials Unit Dropping the word clinical Trials and other well designed studies

6. Strategy Portfolio Industry Involving People IS Methods development

7. Portfolio - domains Current Infections Behaviour Change Children & Young People In Development Medical Devices

8. How do we decide what to work on? Ideas come from internal or external groups/individuals Considered by the Executive Management Group for adoption by the unit on a monthly basis Decision considers capacity within the unit fit with strengths and strategic plans CRC Cymru and UKCRC links Potential to improve the care of patients or the health and wellbeing of the general public

9. What makes an intervention complex? Number of interacting components to intervention Number and difficulty of behaviours required Number of organisational levels targeted Number and variability of outcomes Degree of flexibility and tailoring of intervention permitted

10. Developing and evaluating complex interventions Theoretical understanding of how intervention causes change Distinguish between implementation failure and lack of effect Complex study designs often required More than one primary outcome may be required to capture effect Intervention may need core and flexible components

11. Framework for evaluation (2000) theorymodellingefficacyeffectiveness

12. Framework for evaluation (2008) Development Identifying evidence base Developing theory Modelling process and outcome Identifying and combining components Feasibility Testing procedures Estimating recruitment and retention Determining sample size Determining acceptability Evaluation Assessing effectiveness Understanding change process Assessing cost effectiveness Assessing fidelity of intervention delivery Implementation Dissemination Surveillance and monitoring Long-term follow-up Modelling real world up-take

13. Mixed methods Departure from the Quantitative – Qualitative divide Often used to describe parallel rather than mixed methods More common in trials of complex rather than simple interventions

14. Framework Triangulation Complementary Development Initiation Expansion

15. Analysis strategies Data transformation Typology development Extreme case analysis Data consolidation/merging Integrated inference or analysis?

16. Development Identifying evidence base Developing theory Modelling process and outcome Identifying and combining components Feasibility Testing procedures Estimating recruitment and retention Determining sample size Determining acceptability Evaluation Assessing effectiveness Understanding change process Assessing cost effectiveness Assessing fidelity of intervention delivery Implementation Dissemination Surveillance and monitoring Long-term follow-up Modelling real world up-take Triangulation Complementary Development Initiation Expansion

17. Rehabilitation research Majority of interventions complex Outcomes measures need developing and refining Perceived challenges often lead to focus on easier targets in disease specific groups Motivating evidence based practice/embedding research culture

18. Rehabilitation research group Opportunities for: Strong methodological development Major impact on patients setting the agenda for the next decade Needs support to develop: Critical mass Profile

19. …a mixed method approach to social inquiry distinctively offers deep and potentially inspirational and catalytic opportunities to meaningfully engage with the differences that matter in todays troubled world, seeking not so much convergence and consensus as opportunities for respectful listening and understanding. Greene, 2008

20. Key references Developing and evaluating complex interventions: the new MRC guidance. Craig et al, BMJ, 2008. Framework for the design and evaluation of complex interventions to improve health. Campbell et al, BMJ, 2000. Is mixed methods social inquiry a distinctive methodology? Greene, Journal of Mixed Methods Research, 2008. Data analysis strategies for mixed-methods evaluation designs. Caracelli et al, Educational Evaluation and Policy Analysis, 1993. Towards a conceptual framework for mixed-method evaluation designs. Greene et al, Educational Evaluation and Policy Analysis, 1989.