Asthma action plans, pelvic floor muscle training, and a pre-hospital sepsis screening tool are just a few of the complex interventions researched by Unit staff. They are 'interventions' because they are used in a deliberate effort to make a difference to people's lives, and they are 'complex' because they have many interacting parts that work for different people in different ways. The importance of developing interventions well is increasingly recognised, with Pilot and Feasibility Studies (a sister journal to Trials) initiating a special series to encourage reporting, edited by the Unit's . Our new INDEX (IdeNtifying and critiquing different approaches to Developing complEX interventions) study team will investigate the many ways researchers have gone about developing complex interventions, and use this knowledge to produce comprehensive guidance.
The INDEX study is led by Alicia O'Cathain at ScHARR, University of Sheffield, with Pat and from the Unit as co-investigators, along with colleagues from the Universities of Bristol and Southampton. Pat explains, "Careful development and evaluation of complex interventions is crucial if we are to avoid wasting time and money on trials of interventions which are flawed or would never work in the real world. Up-to-date guidance will help researchers and funders improve their practice and decision making based on the best available evidence."
INDEX is funded by the Medical Research Council which last published a framework for developing complex interventions in 2008. The study has three stages, starting with a methodological review of approaches to intervention development in health, education and social research. This will be followed by a qualitative intervention study - led by University of Stirling - with people who have been involved in intervention development, and a consensus phase to identify core aspects of intervention development and inform implementation of the guidance.