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Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section

Artikel i vetenskaplig tidskrift
Författare P. Healy
V. Smith
G. Savage
M. Clarke
D. Devane
M. M. Gross
S. Morano
D. Daly
S. Grylka-Baeschlin
J. Nicoletti
M. Sinclair
R. Maguire
M. Carroll
Cecily Begley
Publicerad i Trials
Volym 19
ISSN 1745-6215
Publiceringsår 2018
Publicerad vid Institutionen för vårdvetenskap och hälsa
Språk en
Länkar doi.org/10.1186/s13063-017-2401-x
Ämnesord Process evaluation, Fidelity, Complex intervention, Randomised controlled trial, VBAC, Midwifery, high vbac rates, centered interventions, clinical-trials, women, countries, fidelity, views, implementation, criteria
Ämneskategorier Reproduktiv och perinatal omvårdnad

Sammanfattning

Background: 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). 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. Methods: We 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. Results: Engagement 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. Conclusion: Nesting 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.

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