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Some highly complex interventions pandora rings, such as the Sure Start intervention to support families with young children in deprived communities,8 may comprise a set of individually complex interventions.Box 1 What makes an intervention complex?Number of interacting components within the experimental and control interventionsNumber and difficulty of behaviours required by those delivering or receiving the interventionNumber of groups or organisational levels targeted by the interventionNumber and variability of outcomesDegree of flexibility or tailoring of the intervention permittedHow these characteristics are dealt with will depend on the aims of the evaluation. A key question in evaluating complex interventions is whether they are effective in everyday practice (box 2).9 It is therefore important to understand the whole range of effects and how they vary, for example, among recipients or between sites. A second key question in evaluating complex interventions is how the intervention works: what are the active ingredients and how are they exerting their effect? Answers to this kind of question are needed to design more effective interventions and apply them appropriately across group and setting.10Box 2 Developing and evaluating complex studiesA good theoretical understanding is needed of how the intervention causes change, so that weak links in the causal chain can be identified and strengthenedLack of effect may reflect implementation failure (or teething problems) rather than genuine ineffectiveness; a thorough process evaluation is needed to identify implementation problemsVariability in individual level outcomes may reflect higher level processes; sample sizes may need to be larger to take account of the extra variability and cluster randomised designs consideredA single primary outcome may not make best use of the data; a range of measures will be needed and unintended consequences picked up where possibleEnsuring strict standardisation may be inappropriate; the intervention may work better if a specified degree of adaptation to local settings is allowed for in the protocolThe 2000 framework characterised the process of development through to implementation of a complex intervention in terms of the phases of drug development.