Trial reportTrials2018
Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section.
Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Exploring the content and delivery of feedback facilitation co-interventions: a systematic review.Implementation science : IS · 2024Pooled it
- Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation.BMC medical research methodology · 2024Trial
- OptiBIRTH: a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section.BMC pregnancy and childbirth · 2020Trial
- The application of a tool for supporting shared decision making in primiparous women during early labour - a descriptive survey of obstetric health care professionals' opinion.BMC health services research · 2024Article
- Educational interventions targeting pregnant women to optimise the use of caesarean section: What are the essential elements? A qualitative comparative analysis.BMC public health · 2023Article
- Interventions targeting healthcare providers to optimise use of caesarean section: a qualitative comparative analysis to identify important intervention features.BMC health services research · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.