Main Findings
RESPITE and BUMPES findings had not been widely adopted, with limited knowledge of the trials and concerns that many, particularly midwives, lacked skills to apply evidence. Workforce shortages and resource availability were prominent barriers. Clinicians described difficulty in implementing new practices alongside complex clinical tasks and mandatory duties. Maternity unit cultural norms and senior leader perspectives could enable or hinder implementation, as could individual clinician beliefs and attitudes. Women’s perspectives had limited influence as they were rarely informed or offered the interventions. Incorporation of interventions in guidelines or policies, and clinician exposure to interventions through training and practice facilitated adoption in some units. Being a trial site encouraged but did not guarantee sustained adoption. While dissemination and implementation activities were welcomed, many felt more was needed. Most influences were common across contexts and trials, with some intervention and trial-specific barriers. Remifentanil, a potent opiate, involved specific safety concerns and workforce requirements. BUMPES findings contradicted reported beliefs, teaching and practice about the role of gravity in spontaneous vaginal birth (SVB).
To our knowledge this is the first study to explore maternity trial implementation across more than one intervention or study. Participants included intrapartum care clinicians and trial investigators from most UK regions, with a range of professional backgrounds and experiences. The study was underpinned by behavioural science which gave a structured, theory-based framework to explore implementation. The authors were not involved in the trials, but had professional connections to some trial investigators. While their relative ‘insider’ status enabled open discussion, it may have influenced participants’ willingness to share negative views, and the researchers’ interpretation of findings. It is likely that clinicians with more positive attitudes to research were willing to participate. Quantitative summaries of trial awareness and adoption must be interpreted with caution due to the small non-random sample.
Interpretation
The data provides evidence that our initial impression was correct: neither intervention was widely adopted or sustained. Publication does not guarantee adoption,(1, 2, 18–20) and the many generic barriers to evidence-based practice are also well-known.(21) Publication of RESPITE and BUMPES in leading journals did not effectively reach professionals or women. While the need for diverse approaches to dissemination is recognised,(20) the practicalities and resource implications are substantial. Our findings also suggest gaps in research knowledge and evidence interpretation, particularly among midwives, supportive of calls for increased capacity building for this group.(22–24) While research active organisations more readily adopt evidence,(25) our findings indicate that effective interventions may not be sustained even where hospitals host trials. This highlights the need to optimise the translation of evidence into practice.(6, 7, 26) Work before, during and following trials, underpinned by implementation theory, can identify and mitigate challenges, including whether clinicians perceive interventions as necessary, theoretically sound, safe, feasible, affordable and relevant(27, 28). RESPITE and BUMPES interventions are complex, and increasingly, process evaluation is undertaken alongside complex intervention trials to interrogate implementation.(29)
Additional ‘generic’ implementation barriers, included shortages of staff, equipment and drugs, training and support, and gaps in guidelines, policies and patient information.(4)(20, 21) The study was conducted following the COVID-19 pandemic at a time of low morale and staff shortages.(40) This was a very different context to the timing of the original trials, and clinicians also lacked the clinical research support, common purpose and incentives that trial participation brings.(30)
Our study highlights how individual practitioner, intervention and organisational context and policy are critical,(20) and generic implementation barriers interact with more specific issues. For example, remifentanil requires staff to provide one-to-one care because of its potential side effects. There was reluctance to accept trial results, or their generalisability. Safety concerns regarding the use of narcotics added another barrier. The RESPITE trial was powered on effectiveness but not safety. The number needed to treat may be much lower than number needed to harm, but the latter could represent a much more serious event, and a reason for non-adoption(2). Where effectiveness is not enough to change practice, trials might have to be designed to demonstrate safety.(31) Some interventions do not challenge cultural norms and can be easily incorporated into existing routines, such as adoption of planned caesarean section for breech presentation favoured by many obstetricians,(32, 33). However, BUMPES and RESPITE required people to change practise. Given the difficulty of making change, staff instead carried on as before, with minimal incentive or pressure to change, meaning cultural norms had not shifted.
It is necessary to temper expectations regarding the role of single studies in changing practice. Regardless of quality, they may not provide the evidence required: when the BUMPES trial was incorporated in an updated Cochrane review exploring birth position, it resulted in a minor alteration, but was not sufficient to change the overall conclusions.(34) Some may be cautious to immediately adopt trial findings before clinical guidelines are updated.(2) Incorporating interventions in clinical guidelines may expedite adoption, but frequently occurs some years after trial publication. In 2023 the updated English National Institute for Health and Care Excellence (NICE) Intrapartum Care guidelines(35) added recommendations from both BUMPES(8) and RESPITE(9), six to seven years following publication of findings. While the guideline states a lateral position may increase SVB, it recommends women can use any comfortable position in the second stage of labour. Remifentanil was recommended for women wanting ‘ongoing pain relief during labour and birth’.(35)
Even where evidence-based guidelines and policy are mandated, substantial challenges must be overcome, and they may not be implemented.(36, 37) In a recent freedom of information request about intrapartum analgesia 55/108 responding UK NHS trusts offered remifentanil (18 offered it only where epidural was contraindicated), due to shortages of staff and/or remifentanil.(38)
As in other areas of healthcare,(2) UK maternity services are required to adopt many interventions(39) which they must prioritise in a context of significant safety concerns. It may be that interventions that are mandated and include financial incentive have higher priority such as the Clinical Negligence Scheme for Trusts.(40) Cognitive overload is linked to burnout, errors and poor outcomes.(41–43) Mitigating the cognitive burden which the ever-growing evidence base and policy context brings could create capacity to adopt effective practices. Strategies include decision support tools, machine learning,(42) incorporating time considerations into guidelines(44) and de-implementation of low-value interventions and policies(45). Consolidating and prioritising interventions may simplify the task for clinicians. NHS England produced a maternity and neonatal delivery plan in response to calls for “One clear plan that looks to encompasses the recommendations from various reports.”(46) However, this does not consolidate evidence-based guidelines and emerging research, and further work is required to understand how to support clinicians to navigate this.