Abstract
BackgroundComplex interventions encompassing several interconnecting and interacting components can be challenging to evaluate. Examining the underlying trial processes while an intervention is being tested can assist in explaining why an intervention was effective (or not). This paper describes a process evaluation of a pan-European cluster randomised controlled trial, OptiBIRTH (undertaken in Ireland, Italy and Germany), that successfully used both quantitative and qualitative methods to enhance understanding of the underlying trial mechanisms and their effect on the trial outcome.MethodsWe carried out a mixed methods process evaluation. Quantitative and qualitative data were collected from observation of the implementation of the intervention in practice to determine whether it was delivered according to the original protocol. Data were examined to assess the delivery of the various components of the intervention and the receipt of the intervention by key stakeholders (pregnant women, midwives, obstetricians). Using ethnography, an exploration of perceived experiences from a range of recipients was conducted to understand the perspective of both those delivering and those receiving the intervention.ResultsEngagement by stakeholders with the different components of the intervention varied from minimal intensity of women’s engagement with antenatal classes, to moderate intensity of engagement with online resources, to high intensity of clinicians’ exposure to the education sessions provided. The ethnography determined that, although the overall culture in the intervention site did not change, smaller, more individual cultural changes were observed. The fidelity of the delivery of the intervention scored average quality marks of 80% and above on repeat assessments.ConclusionNesting a process evaluation within the trial enabled the observation of the mode of action of the intervention in its practice context and ensured that the intervention was delivered with a good level of consistency. Implementation problems were identified as they arose and were addressed accordingly. When dealing with a complex intervention, collecting and analysing both quantitative and qualitative data, as we did, can greatly enhance the process evaluation.Trial registrationCurrent Controlled Trials Register, ISRCTN10612254. Registered on 3 April 2013.
Highlights
Complex interventions encompassing several interconnecting and interacting components can be challenging to evaluate
We report on the OptiBIRTH process evaluation procedures, fidelity to the intervention at the 15 trial sites and preliminary findings from the embedded ethnographic study
This paper describes the pragmatic conduct of a process evaluation that ran parallel with the conduct of the OptiBIRTH trial
Summary
Complex interventions encompassing several interconnecting and interacting components can be challenging to evaluate. Examining the underlying trial processes while an intervention is being tested can assist in explaining why an intervention was effective (or not). Evaluation of the underlying processes of a complex study assists in explaining why an intervention has failed unexpectedly or has unforeseen consequences or why a particular intervention is successful in achieving its outcome, and how that success can be optimised [1]. Process evaluations are important in cluster randomised trials, where the studies take place across several sites with a variety of contexts in which the intervention is both delivered and received. In these situations a ‘standardised’ intervention may, in reality, be implemented in different ways or be the subject of different reactions [2]. Variation in intervention delivery has implications for both internal and external validity and reduces the potential for generalisability of findings
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