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Open Access Research article

"Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

Lydia Bird*, Antony Arthur and Karen Cox

Author Affiliations

Faculty of Medicine and Health Sciences, School of Nursing, Midwifery and Physiotherapy, B49 Research Office, Queen's Medical Centre, University of Nottingham, NG7 2HA, UK

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BMC Medical Research Methodology 2011, 11:24  doi:10.1186/1471-2288-11-24

Published: 1 March 2011

Abstract

Background

The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking.

Methods

Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation.

Results

This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place.

Conclusions

A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.