Complex Interventions Division
- Group summary: Our work in Complex Interventions involves both definitive, large-scale, national, randomised controlled trials and earlier-phase research, including pilots, feasibility studies and intervention development; epidemiological studies and evidence synthesis; together with methodological research investigating real-world challenges of complex intervention evaluations.
What we do
What is a complex intervention? It is "any deliberate initiated attempt to introduce new, or modify existing patterns, of collective action in healthcare or formal organisational setting intended to lead to changed outcomes" (1)
Our work in Complex Interventions involves the design, conduct, analysis and dissemination of large, multi-centre, pragmatic, phase III, randomised, controlled trials, evaluating complex health and social care interventions across a wide range of clinical specialities and settings, including stroke, older people, mental health, diet & obesity, cancer & palliative care, secondary, primary & community care and across transitions of care.
Interventions under evaluation comprise multiple interacting components, underpinned by theory-driven processes, such as rehabilitation, self-management, psychological, behavioural, supportive or lifestyle interventions, as well as complex drug regimens. Interventions target individual, or groups of, patients, care-givers, health / care professionals or organisations.
Our portfolio also includes early-phase research, such as pilots, feasibility studies and intervention development; epidemiological studies and evidence synthesis; together with an active programme of methodological research investigating a broad range of real-world issues encountered during the design, implementation or analysis of complex intervention evaluations.
Major methodological research themes include:
- Clustering and multi-level structures.
- Design and analysis of early phase complex intervention studies.
- Development and appraisal of outcomes and measurement tools.
- Use of routine data in the design, implementation and analysis of clinical trials.
- Design of process evaluations, including methods for maximising, measuring and monitoring intervention fidelity.
Our innovative, pragmatic trials compare complex interventions, to standard NHS or social care, by assessing effectiveness across multiple, patient-focussed outcomes, including symptom reduction, improvements in physical and mental health, activities of daily living, quality of life and other patient-reported outcomes, and cost effectiveness.
We answer questions, which are key to our stakeholders, including investigators, patients, healthcare providers, policy makers and the NHS. Our trials provide evidence which change clinical practice in the United Kingdom, Europe and world-wide.
References
- Understanding the implementation of complex interventions in health care: the normalization process model.
May C, Finch T, Mair F, Ballini L, Dowrick C, Eccles M, Gask L, MacFarlane A, Murray E, Rapley T, Rogers A, Treweek S, Wallace P, Anderson G, Burns J, Heaven B.
BMC Health Serv Res. 2007 Sep 19;7:148.
Our trials
Funding
- National Institute for Health and Care Research
- Yorkshire Cancer Research
- Macmillan Cancer Support
- National Institues of Health
- Medical Research Council
- Chartered Society for Physiotherapy
- Wellcome Trust
Key publications
Key publications our team has contributed to
- Effectiveness of systemic family therapy versus treatment as usual for young people after self-harm: a pragmatic, phase 3, multicentre, randomised controlled trial.
Cottrell DJ, Wright-Hughes A, Collinson M, Boston P, Eisler I, Fortune S, Graham EH, Green J, House AO, Kerfoot M, Owens DW, Saloniki EC, Simic M, Lambert F, Rothwell J, Tubeuf S, Farrin AJ.
Lancet Psychiatry. 2018 Mar;5(3):203-216. doi: 10.1016/S2215-0366(18)30058-0. Epub 2018 Feb 12.
- Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.
Forster A, Young J, Chapman K, Nixon J, Patel A, Holloway I, Mellish K, Anwar S, Breen R, Knapp M, Murray J, Farrin A.
Stroke. 2015 Aug;46(8):2212-9. doi: 10.1161/STROKEAHA.115.008585. Epub 2015 Jul 7.
- A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis.
Forster A, Dickerson J, Young J, Patel A, Kalra L, Nixon J, Smithard D, Knapp M, Holloway I, Anwar S, Farrin A; TRACS Trial Collaboration.
Lancet. 2013 Dec 21;382(9910):2069-76. doi: 10.1016/S0140-6736(13)61603-7. Epub 2013 Sep 18.
Key methods publications
- Routine hospital data - is it good enough for trials? An example using England's Hospital Episode Statistics in the SHIFT trial of Family Therapy vs. Treatment as Usual in adolescents following self-harm.
Wright-Hughes A, Graham E, Cottrell D, Farrin A.
Clin Trials. 2018 Apr;15(2):197-206. doi: 10.1177/1740774517751381. Epub 2018 Mar 2.
- Understanding the implementation of complex interventions in health care: the normalization process model.
May C, Finch T, Mair F, Ballini L, Dowrick C, Eccles M, Gask L, MacFarlane A, Murray E, Rapley T, Rogers A, Treweek S, Wallace P, Anderson G, Burns J, Heaven B.
BMC Health Serv Res. 2007 Sep 19;7:148.
- Statistical challenges in assessing potential efficacy of complex interventions in pilot or feasibility studies.
Wilson DT, Walwyn RE, Brown J, Farrin AJ, Brown SR.
Stat Methods Med Res. 2016 Jun;25(3):997-1009. doi: 10.1177/0962280215589507. Epub 2015 Jun 12.
- Systematic review to identify and appraise outcome measures used to evaluate childhood obesity treatment interventions (CoOR): evidence of purpose, application, validity, reliability and sensitivity.
Bryant M, Ashton L, Brown J, Jebb S, Wright J, Roberts K, Nixon J.
Health Technol Assess. 2014 Aug;18(51):1-380. doi: 10.3310/hta18510. Review.
Who we are
Division Director
Professor Amanda Farrin
Contact us
General enquiries
Email: ctru_cid@leeds.ac.uk