Researching Complex Interventions in Health: The State of the Art

Craig, Peter and Rahm-Hallberg, Ingalill and Britten, Nicky and Borglin, Gunilla and Meyer, Gabriele and Köpke, Sascha and Noyes, Jane and Chandler, Jackie and Levati, Sara and Sales, Anne and Thabane, Lehana and Giangregorio, Lora and Feeley, Nancy and Cossette, Sylvie and Taylor, Rod and Hill, Jacqueline and Richards, David A. and Kuyken, Willem and von Essen, Louise and Williams, Andrew and Hemming, Karla and Lilford, Richard and Girling, Alan and Taljaard, Monica and Dimairo, Munyaradzi and Petticrew, Mark and Baird, Janis and Moore, Graham and Odendaal, Willem and Atkins, Salla and Lutge, Elizabeth and Leon, Natalie and Lewin, Simon and Payne, Katherine and van Achterberg, Theo and Sermeus, Walter and Pitt, Martin and Monks, Thomas (2016) Researching Complex Interventions in Health: The State of the Art. BMC Health Services Research, 16 (S1). ISSN 1472-6963

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RCTs are recognised as the ‘gold standard’ methodology in the evaluation of complex interventions, however, they often fail to detect whether the lack of intervention effect is due to sub optimal design, implementation failure or genuine ineffectiveness. Given the current financial constraints upon health services research, it is increasingly important to define pre-trial optimisation methods that can give indications on how the intervention works and help maximise chances for the intervention to be effective. This scoping review provides a map of the health literature on pre-trial strategies aimed at optimising complex interventions before a RCT and a snapshot of the methods currently used. Scholarly literature was searched using MEDLINE, CINAHL, AMED, PsycINFO and ProQuest Nursing & Allied Health Source for papers published between January 2000 and March 2015 available in English language. The literature search identified 3940 unique references, 27 of which met the inclusion criteria. Optimisation strategies explored the feasibility and acceptability of the intervention to patients and healthcare professionals, estimated the effectiveness and cost-effectiveness of different combinations of components and identified potential barriers to implementation. Large variations in the methods adopted were noted across studies, including interviews and focus groups with interventions’ providers and receivers, experts consultations, economic modelling, small uncontrolled pilot studies and evaluation questionnaires. Overall, there is the potential for optimisation strategies to detect, in a cost-effective way, those interventions and components that are likely to fail or show little effect if implemented in a full-scale RCT.

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