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

Trials
Patricia HealyCecily Begley

Abstract

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. 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. Engagement by stakeholders with the diffe...Continue Reading

References

Jan 29, 2002·Journal of Epidemiology and Community Health·L RychetnikA Shiell
Jan 17, 2004·Nursing Research·Sheila Judge SantacroceMargaret Grey
Jun 26, 2004·BMJ : British Medical Journal·Penelope HaweTherese Riley
Feb 18, 2006·BMJ : British Medical Journal·Ann OakleyUNKNOWN RIPPLE Study Team
Oct 1, 2008·BMJ : British Medical Journal·Peter CraigUNKNOWN Medical Research Council Guidance
Apr 19, 2011·Journal of Public Health Dentistry·Belinda Borrelli
May 27, 2017·Women and Birth : Journal of the Australian College of Midwives·Christina NilssonPatricia Healy

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Clinical Trials Mentioned

ISRCTN10612254

Software Mentioned

OptiBIRTH
QUALTRICS
icanbirth

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