Exploring implementation of intrapartum trial evidence: a qualitative study with clinicians and clinical academics

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This study aim was to explore implementation of two intrapartum trials with compelling findings: BUMPES (position in second stage of labour in nulliparous women with epidural), and RESPITE (remifentanil intravenous patient-controlled analgesia). Methods : A qualitative interview study set in UK National Health Service Trusts and Universities. Purposively sampled investigators from RESPITE and BUMPES trials and clinicians providing intrapartum care: midwives, anaesthetists, and obstetricians, were recruited using existing networks and snowball sampling. Semi-structured virtual interviews were conducted. Thematic analysis was underpinned by Capability Opportunity Motivation Behaviour Change Framework. Results : Twenty-nine interview participants across 19 maternity units: 11 clinical academics, 10 midwives, 4 obstetricians, 4 anaesthetists. Most (25/29) were aware of one or both trials. BUMPES had been implemented in 4/19 units (one original trial site) and RESPITE in 3/19 units (two trial sites). Access to sufficient resources, training, exposure to interventions, support from leaders, and post-trial dissemination and implementation activities all facilitated uptake of interventions. Some clinicians were opposed to the intervention or disagreed with trial conclusions. However competing priorities in terms of staff time and a plethora of initiatives in maternity care, emerged as key barrier to implementation. Conclusions : Compelling trial findings were not implemented widely, and numerous barriers and facilitators were identified. Large-scale improvement programmes and evidence-based national guidelines may mean single trials have limited potential to change practice. There is a need to examine how intervention implementation is prioritised to optimise safety outcomes in the context of workforce restrictions, limited resources and large arrays of competing priorities including statutory requirements, that have increased in maternity care. Implementation science Maternal health services Obstetric analgesia Obstetric labor CONTRIBUTION TO THE LITERATURE Implementation science theories and frameworks are largely absent from maternity services research, particularly intrapartum care. This study is the first to explore factors influencing implementation of findings from two compelling randomised-control-trials in intrapartum care, using the COM-B behaviour change framework. Trial findings were not widely adopted. Multiple barriers were identified relating to clinicians’ capability and opportunity including skills to apply evidence. Clinicians are required to implement multiple policy and research recommendations whilst often not having the adequate training, tools or capacity to do so. Incorporating implementation science within maternity services can help guide realistic evidence-based practice whilst optimising implementation processes. INTRODUCTION Randomised controlled trials are the gold standard of clinical evidence, however implementation of findings can take years, or may never occur.( 1 , 2 ) Although there have been studies on uptake of evidence in maternity care going back to the last century,( 3 ) the use of theory, models and frameworks to underpin implementation in maternity is limited compared with other settings.( 4 , 5 ) It has therefore been suggested there is a need for implementation science approaches to be tailored and tested in maternity contexts.( 6 ) The lack of maternity implementation research has been highlighted as a priority in the USA to improve evidence-based practice, and address disparities in maternal health.( 7 ) This study aimed to explore the influences on implementation of trial findings in NHS maternity care using behaviour change theory. Two recent intrapartum care intervention trials published in high impact journals were selected as exemplars to explore implementation, BUMPES( 8 ) and RESPITE.( 9 ) In the years following publication of trial findings, researchers and clinical colleagues in the authors’ professional networks had expressed concerns that the interventions had not been widely adopted, but reasons were not understood. BUMPES( 8 ) compared upright with a left or right lateral position in the second stage of labour for nulliparous women with epidural. It found a 5.9% absolute increase in the chance of spontaneous vaginal birth when lying down (adjusted risk ratio 0.86, 95% confidence interval 0.78 to 0.94).( 10 ) RESPITE( 9 ) explored remifentanil intravenous patient-controlled analgesia as an alternative to intramuscular pethidine for women in established labour. The absolute risk of the primary outcome, progression to epidural, was lower with remifentanil (19%) than pethidine (41%) (risk ratio 0·48, 95% CI 0·34–0·66; p < 0·0001). Remifentanil resulted in fewer instrumental and more spontaneous vaginal births. METHODS Study design and theoretical framework This qualitative interview study used the Capability, Opportunity and Motivation (COM-B) behaviour change framework( 11 , 12 ) to explore influences on clinicians’ implementation of trial findings. COM-B has been applied to understand implementation in other maternity contexts.( 13 ) It defines three domains of influence on individual behaviour (B): capability (C), opportunity (O), and motivation (M). These domains interact, and influences on behaviour can be negative or positive. The domains are described in Table 1 . Table 1 Themes and subthemes arranged using the COM-B framework Theoretical framework (Influences on behaviour) Qualitative analytical themes/subthemes Role of influence in RESPITE/BUMPES COM-B domain COM-B subdomain Theme Subtheme Barrier Facilitator Capability Psychological Capability (individuals’ knowledge, cognitive capacity/skill e.g. memory) KNOWLEDGE AND SKILLS Knowledge of the evidence Skills to interpret evidence Physical Capability (individuals’ physical strength and skill) N/A (no examples identified) Opportunity Physical Opportunity (environmental cues and resources, e.g. time, money) THE PHYSICAL ENVIRONMENT Workforce Guidelines and policies Resources, funding and supply Social Opportunity (elements of the social environment e.g. cultural norms, perspectives and social cues) THE CLINICAL AND SOCIAL CONTEXT Clinical cultural norms Leaders’ influence Training and exposure to the intervention Women’s experiences THE TRIAL AND INTERVENTION CONTEXT Trial dissemination and implementation efforts Involvement in the trials Motivation Automatic Motivation (unconscious internal processes e.g. desires, emotional responses, inhibitions, habits) INDIVIDUAL CLINICIANS’ MOTIVATION Competing priorities Perceptions and beliefs about the intervention and trial findings Reflective Motivation (conscious processes e.g. making plans, beliefs, values, goals) Setting and eligibility Clinicians and clinician researchers working in UK National Health Service inpatient maternity units and/or higher education institutions were eligible to take part (Table 2 ). Table 2 Participant characteristics Characteristics Number of participants Participant role Clinical academics involved in the trials* 11 Obstetric anaesthetist 4 Senior intrapartum midwife 10 Obstetrician 4 Working clinically/linked to trial site BUMPES only 11 RESPITE only 3 RESPITE and BUMPES 4 Not working in a trial site 11 Region of the UK East of England 2 London 5 Midlands 9 Northeast and Yorkshire 5 Northwest 1 Southeast 1 Northern Ireland 1 Wales 5 Total 29 * 3 no longer in clinical practice Participants, sampling and recruitment Participants were purposively sampled from four groups to gather a range of experiences of maternity care and trials: maternity clinical academics affiliated with higher education institutions who held leadership roles in the RESPITE and/or BUMPES trials (chief, principal or co-investigator); senior midwives (e.g. intrapartum matron), obstetricians and anaesthetists working in NHS intrapartum care settings (Table 2 ). We aimed to recruit 4–12 individuals from each group (total 24–36). Participants were identified via the authors’ existing clinical and research networks, open recruitment at conferences, and snowballing via other participants. Data collection Virtual semi-structured video interviews were conducted November 2022-April 2023. Participants provided written or verbal consent following information sharing about the study. A structured topic guide (supplementary information S1) explored trial implementation facilitators and barriers. Participants were offered coffee vouchers as compensation. Interviews were audio recorded digitally, transcribed verbatim and anonymised. Interviews were conducted by [X] a midwife and research fellow (described below). A reflexive diary was maintained throughout.( 14 ) Data analysis Thematic analysis was conducted using a deductive codebook approach. ( 15 , 16 ) Following familiarisation with the data, two researchers (X, X), open coded an exemplar transcript. They developed an initial coding index, organising codes and categories within COM-B domains, with separate codes for each trial. In Table 1 we describe the themes and present them alongside the relevant domains of the COM-B framework. The index was applied to the remaining data. Codes were reviewed and discussed iteratively by X, X and X, analytical summaries were written by X, integrating and comparing analysis from both trials. Initial analysis was discussed with public contributors and clinical and non-clinical academics before writing up final themes. Analysis continued until data saturation was established. Qualitative data were managed using the QSR NVivo 12 software programme.( 17 ) All authors are female experienced maternity services researchers, with backgrounds in midwifery (X, X), public health (X) and implementation science (X). Patient and Public Involvement and Engagement The design, conduct, analysis and interpretation of findings were regularly discussed with public contributors from NIHR ARC West Midlands at throughout the study. RESULTS Twenty-nine participants were interviewed (mean duration 40 minutes, range 29–53) from 19 NHS hospital boards/trusts and five Higher Education Institutions (Table 2 ). Themes and subthemes are presented alongside the relevant COM-B domain in Table 1 . Knowledge and skills Knowledge of the evidence Most participants (n = 25) were aware of one or both of the trials, whether they were based in a trial site or not. However, many had limited recall and understanding of the trials, with some stating incorrect findings. I thought that it had shown that the upright posture in labouring women with an epidural was associated with a higher change of having a successful vaginal delivery. RB27 Anaesthetist Non-trial site Skills to interpret evidence It was suggested that clinicians faced challenges in engaging with, interpreting and applying evidence, particularly midwives who had fewer undergraduate and postgraduate research training and practice opportunities. Our midwives in our unit they’re wonderful, but they’re overworked, they don’t really get to attend a lot of study days… I feel that quite a lot of the midwives in our unit are a bit behind with their knowledge stuff. RB18 Anaesthetist Non-trial site The physical environment Workforce Workforce issues were a repeated and prominent barrier, as staff did not have capacity to adopt new practices with widespread reports of burnout and low morale. Midwives at the moment are extremely burnt out, and any suggestion of extra work, extra research, people are just shutting off. So it’s a really hard time to be going up there and be like, “When you’re in there remember to do this,” because people are just fed up... RB06 Midwife BUMPES trial site Remifentanil is a narcotic and can suppress respiration, and therefore requires one-to-one midwifery care and respiratory monitoring. Often participants saw implementation of remifentanil as almost impossible to operationalise due to insufficient staffing. We used to use remifentanil PCA in on the labour suite, and we stopped using it… the concerns really are about the level of monitoring required compared to the midwifery staffing. RB29 Anaesthetist non-trial site Guidelines and policies Clear and accessible guidelines and policies were described as promoting adoption. However, these were not always available and varied between hospitals. We have a great guideline… Our on-calls are run by trainees, so registrars or SHOs. I think they’re pretty open minded about its use, but as they come and go they want really clear guidelines, which I think we have. So they’re happy if they know they’re safe and okay doing it. RB27 Academic Resources, funding and supply Participants described varied availability of equipment such as pumps to administer remifentanil, and balls, beds and leg supports to support a lateral position in labour. Funding impacted on equipment and training availability, and supply shortages were reported for remifentanil. …We were rationing it to women who needed it because they couldn’t have an epidural rather than to anyone who wanted it. So then we had women coming through wanting to have it but having to be told unfortunately we can’t offer that. RB20 Academic The clinical and social context Clinical cultural norms Adoption of both interventions was hindered by local embedded practices, a culture of slow adoption of change, negative perceptions of interventions and a perception that evidence was not locally relevant. You can do the most amazingly robust trial with the most amazing findings, which are clearcut, which BUMPES was, and you will still get people saying, “Oh well, it wouldn’t work in our unit,” or, “Our women are different.” RB12 Academic Leaders’ influence It was suggested that staff deferred to respected medical leaders, and that midwives had relatively low influence. Endorsement by professional bodies such as Royal Colleges was described as helpful. [Our hospital] does not use remifentanil as a routine…our anaesthetists did not believe that it is a safe drug for labour… there’s enormous respect for our anaesthetists, and if they say they don’t want to use it we go “Okay fine.” RB01 Academic Training and exposure to the intervention Staff exposure to the interventions varied depending on whether organisations had participated in the trials, implemented RESPITE and BUMPES and/or provided training. Staff turnover or rotation necessitated continuous training. Seeing interventions in practice was reported to influence attitudes and behaviour. Most participants stated that findings had not been implemented locally. Four reported that the BUMPES intervention was in regular use (representing 4/19 units, one BUMPES trial site). Three reported that remifentanil was in regular use (representing 3/19 units, two RESPITE trial sites)( Table 3 ). The lack of widespread adoption reduced staff exposure to the intervention and training opportunities. Table 3 Reported adoption of intervention among participants working clinically or linked to BUMPES and RESPITE sites. BUMPES intervention reported in regular use RESPITE intervention reported in regular use Yes No Unknown / Not applicable* Total Yes No Unknown / Not applicable* Total Participant linked to original study site Yes 1 7 7 15 2 4 1 7 No 3 8 3 14 1 19 2 22 Total 4 15 10 29 3 23 3 29 * 3 clinical academics were no longer practicing clinically Midwives need to be trained in monitoring and looking after women with remifentanil, to be familiar with it… if this is a technique that you’re only reserving for women with a contraindication to an epidural, are you then facing a situation where you have staff who are not that familiar with it suddenly doing it in a thrombocytopenic woman. RB07 Anaesthetist non-trial site Women’s experiences Participants widely reported that women did not receive information about interventions, for example posters and antenatal classes promoted upright labour position, and leaflets did not include remifentanil. Participants described how women’s positive or negative experiences of the interventions during the trials influenced subsequent adoption. Women who had been in the [RESPITE] trial with their first pregnancy… it was getting such good feedback, and the number of women coming back and saying “Can I have it again?” was big. RB09 Academic The trial and intervention context Trial dissemination and implementation efforts Findings from both trials were published in high-impact peer-reviewed journals, though at the time of data collection they did not feature in national guidelines. It was suggested that academic outputs did not reach many clinicians. I personally don’t think that midwives read the BMJ any more than an obstetric anaesthetist would. I think the journal was wrong. Even though it’s a really high impact journal and that’s what we aim for. RB29 Anaesthetist non-trial site BUMPES was published in Midwives journal. Dissemination also included sending summaries and posters to trial sites, presentations at national and international conferences, and a BUMPES celebration event. Participants suggested that dissemination should focus on collaboration and include support from external peer organisations. While there were examples of implementation activities (for example a ‘BUMPES champion’ in one site encouraged and reminded midwives to offer women lateral position in second stage), participants articulated a need for more work to translate evidence into practice. This was a general issue rather than specific to RESPITE and/or BUMPES. You’re not going to reap the benefits of that investment in the trial unless you change practice. So I think it’s quite a big issue about wasted resources, and research waste, which is such a big issue. If we do all this really well conducted research and then don’t implement the findings, then all that investment was pointless. RB03 Academic Involvement in the trials Being a trial site provided clinicians with a head-start with resources, training and exposure to the interventions compared to non-trial sites. For a unit which didn’t recruit into the trial, who are trying to introduce something entirely new, however well evidence-based, that as well as the fact that resources are so difficult…I could quite understand why they just hold up their hands and saying, “We can’t do this, it’s just not possible.” RB20 Academic However, trial participation was not a guarantee of sustained practice, with delays between study end and reporting, and limited influence and involvement of researchers in clinical areas. We sadly because of the hiatus…it [practice] didn’t change I would say, but partly it’s because we don’t have a remit within the clinical research team about evidence implementation. RB08 Academic Individual clinician motivation Competing priorities RESPITE and BUMPES interventions had to be balanced with women’s needs and preferences, and clinical and administrative responsibilities. Implementing research findings was challenging in a context of competing priorities, including national safety and quality initiatives. I think most people just go “Gosh we ought to do everything”…it is also led by things we have to do like CQC [Care Quality Commission reporting] and Ockenden [recommendations to improve maternity safety], and we become so full of change that research sometimes can fall to the bottom of that pile. RB13 Obstetrician non-trial site Perceptions and beliefs about the intervention and trial findings It was suggested that individual clinicians varied in their willingness to change established routines and practices. Some clinicians additionally perceived trial effect sizes as small, that single trials had limited relevance, or were sceptical about the validity of results. BUMPES evidence was considered challenging as it contradicted strongly held beliefs about the role of gravity in labour. You think that is the right answer, and when something goes against that idea…there’s a very, very big fixed paradigm, and then quite a small effect, and it’s one trial. RB01 Academic Polarised views regarding the safety of remifentanil were reported. Some clinicians cited fear and anxiety regarding remifentanil use with concerns about safety, and the confidence, competence and resources required to care for women using it. It was suggested that this could be tackled through training and exposure to the intervention. The staff I think were nervous…they think people are going to go into respiratory arrest at the drop of a hat. Of course that hasn’t happened because the dose is so low, and the controls are in place… there’s training around its confidence of course. RB14 Midwife RESPITE site DISCUSSION 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). Strengths and Limitations 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. CONCLUSION This study identified maternity trials with compelling findings were not implemented widely, for reasons documented extensively in implementation science literature. It also indicates single trials may have limited capacity to change practice in the context of evidence-based guidelines underpinned by synthesis of multiple studies. Maternity professionals must navigate and prioritise ever-growing policy, guidance and research recommendations amid quality and safety scrutiny, while tailoring increasingly stretched services to local populations and service contexts. Rigorous, theory-based implementation work must be embedded throughout the maternity research cycle and in practice. However, researchers and policymakers have a duty to deliver evidence and guidance that is realistic and balanced, to support clinicians to prioritise care delivering the best outcomes for women and babies, including de-prioritisation and de-implementation. Further work is required to understand how this can be achieved. Declarations Supporting information This can be found online at the end of the article: Appendix S1. Topic guide for participants Author contributions CRediT roles: FCS: Formal analysis; Methodology; Project administration; Writing - original draft; Writing – review and editing ND: Methodology; Formal analysis; Writing – review and editing SK: Conceptualization; Funding acquisition; Writing - review & editing RL: Conceptualization; Writing – review and editing BT: Conceptualization; Methodology; Formal analysis; Writing - original draft; Writing – review and editing All authors read and approved the final article. Acknowledgements The authors thank all the clinicians and academics who took time out of busy workloads to participate in interviews and share experiences and views with us. Thanks also go to Professor Katie Morris who kindly read and commented on the manuscript. Funding information This work was funded by the National Institute for Health Research (NIHR) grant 970014 through the Applied Research Collaborative (ARC) West Midlands (Maternity Theme) programme. They had no role in the study design, collections, analysis, interpretation of data, in the writing of the report or in the decision to submit the article for publication. The views expressed are those of the authors and not necessarily of the NHS, the NIHR or the Department of Health. Conflict of Interest statement The authors declare no competing interests relating to the study. Data availability statement The datasets generated and analysed during the current study are not publicly available as the authors did not seek ethical permission from the participants, nor the ethics committee, for the data to be used for anything other than this particular research study. The authors therefore do not have explicit permission for data sharing, so would be inappropriate and unethical to make them available in the public domain. Ethics approval and consent to participate Ethical approval was obtained from the University of X Research Ethics Committee for the study (ERN_2022-0350) on 26.10.2022. Informed written or recorded verbal consent was obtained prior to interview. Participation was clearly stated as voluntary, consent could be withdrawn at any time during the research process and all participants were anonymised. Consent for publication Not applicable. References Bauer MS, Kirchner J. Implementation science: What is it and why should I care? Psychiatry Res. 2020;283:112376. Schmidtke KA, Evison F, Grove A, Kudrna L, Tucker O, Metcalfe A, et al. Surgical implementation gap: an interrupted time series analysis with interviews examining the impact of surgical trials on surgical practice in England. BMJ Qual Saf. 2023;32(6):341–56. Wilson B, Thornton J, Hewison J, Lilford R, Watt I, Braunholtz D, et al. The Leeds University maternity audit project. Int J Qual Health Care. 2002;14(3):175–81. 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Patients admitted to more research-active hospitals have more confidence in staff and are better informed about their condition and medication: Results from a retrospective cross-sectional study. J Eval Clin Pract. 2020;26(1):203–8. Hamm RF, Moniz MH, Wahid I, Breman RB, Callaghan-Koru JA, Implementation Science for Maternal Health National Working G. Implementation research priorities for addressing the maternal health crisis in the USA: results from a modified Delphi study among researchers. Implement Sci Commun. 2023;4(1):83. Hunter B. Implementing research evidence into practice: some reflections on the challenges. Evid Based Midwifery. 2013;11(3):76–80. Iravani M, Janghorbani M, Zarean E, Bahrami M. Barriers to Implementing Evidence-Based Intrapartum Care: A Descriptive Exploratory Qualitative Study. Iran Red Crescent Med J. 2016;18(2):e21471. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061. Parkinson B, Meacock R, Sutton M, Fichera E, Mills N, Shorter GW et al. Designing and using incentives to support recruitment and retention in clinical trials: a scoping review and a checklist for design. Trials. 2019;20(1). Girling AJ, Lilford RJ, Braunholtzband DA, Gillett WR. Sample-size calculations for trials that informindividual treatment decisions: a ‘true-choice’approach. Clin Trails. 2007;4:15–24. Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Lancet. 2000;356(9239):1375–83. Partridge B. Conceptual and ethical problems underpinning calls to abandon vaginal breech birth. Women Birth. 2021;34(2):e210–5. Walker KF, Kibuka M, Thornton JG, Jones NW. Maternal position in the second stage of labour for women with epidural anaesthesia. Cochrane Database Syst Rev. 2018;11(11):CD008070. National Institute for. Health & Care Excellence. Intrapartum care. 2023. Bewley S. What inhibits obstetricians implementing reliable guidelines? BJOG. Int J Obstet Gynecol. 2020;127(7):798. Correa VC, Lugo-Agudelo LH, Aguirre-Acevedo DC, Contreras JAP, Borrero AMP, Patiño-Lugo DF et al. Individual, health system, and contextual barriers and facilitators for the implementation of clinical practice guidelines: a systematic metareview. Health Res Policy Syst. 2020;18(1). Kirton H. Labour ward staffing shortages restrict use of beneficial drug 2023 [updated 1 September 2023; cited 2023 30 Oct]. https://www.hsj.co.uk/acute-care/labour-ward-staffing-shortages-restrict-use-of-beneficial-drug-/7035416.article . NHS England. Saving babies’ lives: version 3 2023 [cited 2023 21 Nov]. https://www.england.nhs.uk/long-read/saving-babies-lives-version-3/ . NHS Resolution. Maternity incentive scheme 2023 [cited 2024 08.01]. https://resolution.nhs.uk/services/claims-management/clinical-schemes/clinical-negligence-scheme-for-trusts/maternity-incentive-scheme/ . Graber ML, Kissam S, Payne VL, Meyer AND, Sorensen A, Lenfestey N, et al. Cognitive interventions to reduce diagnostic error: a narrative review. BMJ Qual Saf. 2012;21(7):535–57. Ehrmann DE, Gallant SN, Nagaraj S, Eytan SDG, Goldenberg D. Evaluating and reducing cognitive load should be a priority for machine learning in healthcare. Nat Med. 2022;28:1331–3. Rothschild JM, Landrigan CP, Cronin JW, Kaushal R, Lockley SW, Burdick E, et al. The Critical Care Safety Study: The incidence and nature of adverse events and serious medical errors in intensive care. Crit Care Med. 2005;33(8):1694–700. Johansson M, Guyatt G, Montori V. Guidelines should consider clinicians’ time needed to treat. BMJ. 2023;380:e072953. Ingvarsson S, Hasson H, von Thiele Schwarz U, Nilsen P, Powell BJ, Lindberg C, et al. Strategies for de-implementation of low-value care—a scoping review. Implement Sci. 2022;17:73. NHS England. Three year delivery plan for maternity and neonatal services. 2023. Supplementary Files ISSMCOREQChecklist.pdf S1Trialimplementationinterviewguide.docx Cite Share Download PDF Status: Published Journal Publication published 27 Sep, 2024 Read the published version in Implementation Science Communications → Version 1 posted Reviewers agreed at journal 15 May, 2024 Reviewers invited by journal 14 May, 2024 Editor assigned by journal 24 Apr, 2024 First submitted to journal 23 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4311561","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":302551790,"identity":"51b2a18e-c4e6-4e9e-8f9e-abb132c9d39a","order_by":0,"name":"Fiona Cross-Sudworth","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABBUlEQVRIiWNgGAWjYBAC9gYE2wBEJPBL8MAE2LBq4TmAqsUgQXIGyVoMbhDSwsD87MOHP3UM8jOSt0l83PMnz/h278FPNxjs5Bkk0hKwa2Eznjmz7TCDwY20MskZzwyKze6cS5bOYUg2bJBIO4BNiz0DDzMzb8OB+g0SOWa3eQ4YJG67kWMA1MKcwCCR3oDdFqAWHrDDoFo2z8gx/p3DUE9ACxszA8MNqBaQdUBbDgO1YHcYDzObMSPYL2eelf+cccA4ccadM2bWOQbHDdt4nmH3PnvzYwZwiLUnbzb4cEAusX92j/HtnIpqeX72NANsWhiYsYqC4gh7rIyCUTAKRsEoIAYAAFABWAddISfzAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-5223-1789","institution":"University of Birmingham","correspondingAuthor":true,"prefix":"","firstName":"Fiona","middleName":"","lastName":"Cross-Sudworth","suffix":""},{"id":302551791,"identity":"8360fa65-92d1-4e69-94af-4e3bca3b9cc4","order_by":1,"name":"Nimarta Dharni","email":"","orcid":"","institution":"University of Birmingham","correspondingAuthor":false,"prefix":"","firstName":"Nimarta","middleName":"","lastName":"Dharni","suffix":""},{"id":302551792,"identity":"6c5f42aa-fbbf-485d-bcb2-51e2c280187f","order_by":2,"name":"Sara Kenyon","email":"","orcid":"","institution":"University of Birmingham","correspondingAuthor":false,"prefix":"","firstName":"Sara","middleName":"","lastName":"Kenyon","suffix":""},{"id":302551793,"identity":"46029f82-b81a-48f1-8cad-eb4946f485a1","order_by":3,"name":"Richard Lilford","email":"","orcid":"","institution":"University of Birmingham","correspondingAuthor":false,"prefix":"","firstName":"Richard","middleName":"","lastName":"Lilford","suffix":""},{"id":302551794,"identity":"82165c5e-1b7b-46ed-ba60-63ef003f271f","order_by":4,"name":"Beck Taylor","email":"","orcid":"","institution":"University of Warwick Medical School","correspondingAuthor":false,"prefix":"","firstName":"Beck","middleName":"","lastName":"Taylor","suffix":""}],"badges":[],"createdAt":"2024-04-23 11:09:50","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4311561/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4311561/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s43058-024-00647-z","type":"published","date":"2024-09-27T15:58:06+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":65628593,"identity":"3938b7d6-c5c5-4916-8936-4c8be11e0f2a","added_by":"auto","created_at":"2024-09-30 16:19:18","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":811236,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4311561/v1/f82b7776-790e-43a8-b30d-3e434b6580c1.pdf"},{"id":57016519,"identity":"dadacf5a-41b6-4041-a0e6-a9093b1d775f","added_by":"auto","created_at":"2024-05-23 12:46:38","extension":"pdf","order_by":7,"title":"","display":"","copyAsset":false,"role":"supplement","size":425600,"visible":true,"origin":"","legend":"","description":"","filename":"ISSMCOREQChecklist.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4311561/v1/7c336d7327352ffcd59ec182.pdf"},{"id":57016517,"identity":"981f0227-11b9-4bfa-a43d-93b4c47956c6","added_by":"auto","created_at":"2024-05-23 12:46:36","extension":"docx","order_by":8,"title":"","display":"","copyAsset":false,"role":"supplement","size":25958,"visible":true,"origin":"","legend":"","description":"","filename":"S1Trialimplementationinterviewguide.docx","url":"https://assets-eu.researchsquare.com/files/rs-4311561/v1/64e43d3923bfc8911eb4023f.docx"}],"financialInterests":"","formattedTitle":"Exploring implementation of intrapartum trial evidence: a qualitative study with clinicians and clinical academics","fulltext":[{"header":"CONTRIBUTION TO THE LITERATURE","content":"\u003cul\u003e\n \u003cli\u003eImplementation science theories and frameworks are largely absent from maternity services research, particularly intrapartum care.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThis study is the first to explore factors influencing implementation of findings from two compelling randomised-control-trials in intrapartum care, using the COM-B behaviour change framework.\u003c/li\u003e\n \u003cli\u003eTrial findings were not widely adopted. Multiple barriers were identified relating to clinicians\u0026rsquo; capability and opportunity including skills to apply evidence.\u003c/li\u003e\n \u003cli\u003eClinicians are required to implement multiple policy and research recommendations whilst often not having the adequate training, tools or capacity to do so. Incorporating implementation science within maternity services can help guide realistic evidence-based practice whilst optimising implementation processes.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"INTRODUCTION","content":"\u003cp\u003eRandomised controlled trials are the gold standard of clinical evidence, however implementation of findings can take years, or may never occur.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Although there have been studies on uptake of evidence in maternity care going back to the last century,(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) the use of theory, models and frameworks to underpin implementation in maternity is limited compared with other settings.(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) It has therefore been suggested there is a need for implementation science approaches to be tailored and tested in maternity contexts.(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) The lack of maternity implementation research has been highlighted as a priority in the USA to improve evidence-based practice, and address disparities in maternal health.(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThis study aimed to explore the influences on implementation of trial findings in NHS maternity care using behaviour change theory. Two recent intrapartum care intervention trials published in high impact journals were selected as exemplars to explore implementation, BUMPES(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) and RESPITE.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) In the years following publication of trial findings, researchers and clinical colleagues in the authors\u0026rsquo; professional networks had expressed concerns that the interventions had not been widely adopted, but reasons were not understood.\u003c/p\u003e \u003cp\u003eBUMPES(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) compared upright with a left or right lateral position in the second stage of labour for nulliparous women with epidural. It found a 5.9% absolute increase in the chance of spontaneous vaginal birth when lying down (adjusted risk ratio 0.86, 95% confidence interval 0.78 to 0.94).(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) RESPITE(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) explored remifentanil intravenous patient-controlled analgesia as an alternative to intramuscular pethidine for women in established labour. The absolute risk of the primary outcome, progression to epidural, was lower with remifentanil (19%) than pethidine (41%) (risk ratio 0\u0026middot;48, 95% CI 0\u0026middot;34\u0026ndash;0\u0026middot;66; p\u0026thinsp;\u0026lt;\u0026thinsp;0\u0026middot;0001). Remifentanil resulted in fewer instrumental and more spontaneous vaginal births.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and theoretical framework\u003c/h2\u003e \u003cp\u003eThis qualitative interview study used the Capability, Opportunity and Motivation (COM-B) behaviour change framework(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) to explore influences on clinicians\u0026rsquo; implementation of trial findings. COM-B has been applied to understand implementation in other maternity contexts.(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) It defines three domains of influence on individual behaviour (B): capability (C), opportunity (O), and motivation (M). These domains interact, and influences on behaviour can be negative or positive. The domains are described in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThemes and subthemes arranged using the COM-B framework\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eTheoretical framework\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Influences on behaviour)\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eQualitative analytical themes/subthemes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eRole of influence in RESPITE/BUMPES\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCOM-B domain\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCOM-B subdomain\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTheme\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSubtheme\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBarrier\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eFacilitator\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eCapability\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ePsychological Capability\u003c/p\u003e \u003cp\u003e\u003cem\u003e(individuals\u0026rsquo; knowledge, cognitive capacity/skill e.g. memory)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eKNOWLEDGE AND SKILLS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eKnowledge of the evidence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSkills to interpret evidence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePhysical Capability\u003c/p\u003e \u003cp\u003e\u003cem\u003e(individuals\u0026rsquo; physical strength and skill)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eN/A (no examples identified)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"8\" rowspan=\"9\"\u003e \u003cp\u003eOpportunity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003ePhysical Opportunity\u003c/p\u003e \u003cp\u003e\u003cem\u003e(environmental cues and resources, e.g. time, money)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eTHE PHYSICAL ENVIRONMENT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eWorkforce\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGuidelines and policies\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eResources, funding and supply\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"5\" rowspan=\"6\"\u003e \u003cp\u003eSocial Opportunity\u003c/p\u003e \u003cp\u003e\u003cem\u003e(elements of the social environment e.g. cultural norms, perspectives and social cues)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eTHE CLINICAL AND SOCIAL CONTEXT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eClinical cultural norms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eLeaders\u0026rsquo; influence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTraining and exposure to the intervention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eWomen\u0026rsquo;s experiences\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eTHE TRIAL AND INTERVENTION CONTEXT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTrial dissemination and implementation efforts\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eInvolvement in the trials\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eMotivation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAutomatic Motivation\u003c/p\u003e \u003cp\u003e\u003cem\u003e(unconscious internal processes e.g. desires, emotional responses, inhibitions, habits)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eINDIVIDUAL CLINICIANS\u0026rsquo; MOTIVATION\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eCompeting priorities\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ePerceptions and beliefs about the intervention and trial findings\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eReflective Motivation\u003c/p\u003e \u003cp\u003e\u003cem\u003e(conscious processes e.g. making plans, beliefs, values, goals)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eSetting and eligibility\u003c/h2\u003e \u003cp\u003eClinicians and clinician researchers working in UK National Health Service inpatient maternity units and/or higher education institutions were eligible to take part (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eParticipant characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber of participants\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eParticipant role\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eClinical academics involved in the trials*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eObstetric anaesthetist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSenior intrapartum midwife\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eObstetrician\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eWorking clinically/linked to trial site\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBUMPES only\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRESPITE only\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRESPITE and BUMPES\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot working in a trial site\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"7\" rowspan=\"8\"\u003e \u003cp\u003eRegion of the UK\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEast of England\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLondon\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMidlands\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNortheast and Yorkshire\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNorthwest\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSoutheast\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNorthern Ireland\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWales\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e29\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e* 3 no longer in clinical practice\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eParticipants, sampling and recruitment\u003c/h2\u003e \u003cp\u003eParticipants were purposively sampled from four groups to gather a range of experiences of maternity care and trials: maternity clinical academics affiliated with higher education institutions who held leadership roles in the RESPITE and/or BUMPES trials (chief, principal or co-investigator); senior midwives (e.g. intrapartum matron), obstetricians and anaesthetists working in NHS intrapartum care settings (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). We aimed to recruit 4\u0026ndash;12 individuals from each group (total 24\u0026ndash;36). Participants were identified via the authors\u0026rsquo; existing clinical and research networks, open recruitment at conferences, and snowballing via other participants.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eVirtual semi-structured video interviews were conducted November 2022-April 2023. Participants provided written or verbal consent following information sharing about the study. A structured topic guide (supplementary information S1) explored trial implementation facilitators and barriers. Participants were offered coffee vouchers as compensation. Interviews were audio recorded digitally, transcribed verbatim and anonymised. Interviews were conducted by [X] a midwife and research fellow (described below). A reflexive diary was maintained throughout.(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eThematic analysis was conducted using a deductive codebook approach. (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) Following familiarisation with the data, two researchers (X, X), open coded an exemplar transcript. They developed an initial coding index, organising codes and categories within COM-B domains, with separate codes for each trial. In Table \u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e we describe the themes and present them alongside the relevant domains of the COM-B framework. The index was applied to the remaining data. Codes were reviewed and discussed iteratively by X, X and X, analytical summaries were written by X, integrating and comparing analysis from both trials. Initial analysis was discussed with public contributors and clinical and non-clinical academics before writing up final themes. Analysis continued until data saturation was established. Qualitative data were managed using the QSR NVivo 12 software programme.(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eAll authors are female experienced maternity services researchers, with backgrounds in midwifery (X, X), public health (X) and implementation science (X).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003ePatient and Public Involvement and Engagement\u003c/h2\u003e \u003cp\u003eThe design, conduct, analysis and interpretation of findings were regularly discussed with public contributors from NIHR ARC West Midlands at throughout the study.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eTwenty-nine participants were interviewed (mean duration 40 minutes, range 29\u0026ndash;53) from 19 NHS hospital boards/trusts and five Higher Education Institutions (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThemes and subthemes are presented alongside the relevant COM-B domain in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003ch3\u003eKnowledge and skills\u003c/h3\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eKnowledge of the evidence\u003c/h2\u003e \u003cp\u003eMost participants (n\u0026thinsp;=\u0026thinsp;25) were aware of one or both of the trials, whether they were based in a trial site or not. However, many had limited recall and understanding of the trials, with some stating incorrect findings.\u003c/p\u003e \u003cp\u003e \u003cem\u003eI thought that it had shown that the upright posture in labouring women with an epidural was associated with a higher change of having a successful vaginal delivery.\u003c/em\u003e RB27 Anaesthetist Non-trial site\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eSkills to interpret evidence\u003c/h2\u003e \u003cp\u003eIt was suggested that clinicians faced challenges in engaging with, interpreting and applying evidence, particularly midwives who had fewer undergraduate and postgraduate research training and practice opportunities.\u003c/p\u003e \u003cp\u003e \u003cem\u003eOur midwives in our unit they\u0026rsquo;re wonderful, but they\u0026rsquo;re overworked, they don\u0026rsquo;t really get to attend a lot of study days\u0026hellip; I feel that quite a lot of the midwives in our unit are a bit behind with their knowledge stuff.\u003c/em\u003e RB18 Anaesthetist Non-trial site\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eThe physical environment\u003c/h2\u003e \u003cdiv id=\"Sec14\" class=\"Section3\"\u003e \u003ch2\u003eWorkforce\u003c/h2\u003e \u003cp\u003eWorkforce issues were a repeated and prominent barrier, as staff did not have capacity to adopt new practices with widespread reports of burnout and low morale.\u003c/p\u003e \u003cp\u003e \u003cem\u003eMidwives at the moment are extremely burnt out, and any suggestion of extra work, extra research, people are just shutting off. So it\u0026rsquo;s a really hard time to be going up there and be like, \u0026ldquo;When you\u0026rsquo;re in there remember to do this,\u0026rdquo; because people are just fed up...\u003c/em\u003e RB06 Midwife BUMPES trial site\u003c/p\u003e \u003cp\u003eRemifentanil is a narcotic and can suppress respiration, and therefore requires one-to-one midwifery care and respiratory monitoring. Often participants saw implementation of remifentanil as almost impossible to operationalise due to insufficient staffing.\u003c/p\u003e \u003cp\u003e \u003cem\u003eWe used to use remifentanil PCA in on the labour suite, and we stopped using it\u0026hellip; the concerns really are about the level of monitoring required compared to the midwifery staffing.\u003c/em\u003e RB29 Anaesthetist non-trial site\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eGuidelines and policies\u003c/h2\u003e \u003cp\u003e Clear and accessible guidelines and policies were described as promoting adoption. However, these were not always available and varied between hospitals.\u003c/p\u003e \u003cp\u003e\u003cem\u003e We have a great guideline\u0026hellip; Our on-calls are run by trainees, so registrars or SHOs. I think they\u0026rsquo;re pretty open minded about its use, but as they come and go they want really clear guidelines, which I think we have. So they\u0026rsquo;re happy if they know they\u0026rsquo;re safe and okay doing it.\u003c/em\u003e RB27 Academic\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eResources, funding and supply\u003c/h2\u003e \u003cp\u003eParticipants described varied availability of equipment such as pumps to administer remifentanil, and balls, beds and leg supports to support a lateral position in labour. Funding impacted on equipment and training availability, and supply shortages were reported for remifentanil.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026hellip;We were rationing it to women who needed it because they couldn\u0026rsquo;t have an epidural rather than to anyone who wanted it. So then we had women coming through wanting to have it but having to be told unfortunately we can\u0026rsquo;t offer that.\u003c/em\u003e RB20 Academic\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eThe clinical and social context\u003c/h2\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003eClinical cultural norms\u003c/h2\u003e \u003cp\u003eAdoption of both interventions was hindered by local embedded practices, a culture of slow adoption of change, negative perceptions of interventions and a perception that evidence was not locally relevant.\u003c/p\u003e \u003cp\u003e \u003cem\u003eYou can do the most amazingly robust trial with the most amazing findings, which are clearcut, which BUMPES was, and you will still get people saying, \u0026ldquo;Oh well, it wouldn\u0026rsquo;t work in our unit,\u0026rdquo; or, \u0026ldquo;Our women are different.\u0026rdquo;\u003c/em\u003e RB12 Academic\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eLeaders\u0026rsquo; influence\u003c/h2\u003e \u003cp\u003eIt was suggested that staff deferred to respected medical leaders, and that midwives had relatively low influence. Endorsement by professional bodies such as Royal Colleges was described as helpful.\u003c/p\u003e \u003cp\u003e \u003cem\u003e[Our hospital] does not use remifentanil as a routine\u0026hellip;our anaesthetists did not believe that it is a safe drug for labour\u0026hellip; there\u0026rsquo;s enormous respect for our anaesthetists, and if they say they don\u0026rsquo;t want to use it we go \u0026ldquo;Okay fine.\u0026rdquo;\u003c/em\u003e RB01 Academic\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eTraining and exposure to the intervention\u003c/h2\u003e \u003cp\u003eStaff exposure to the interventions varied depending on whether organisations had participated in the trials, implemented RESPITE and BUMPES and/or provided training. Staff turnover or rotation necessitated continuous training. Seeing interventions in practice was reported to influence attitudes and behaviour.\u003c/p\u003e \u003cp\u003eMost participants stated that findings had not been implemented locally. Four reported that the BUMPES intervention was in regular use (representing 4/19 units, one BUMPES trial site). Three reported that remifentanil was in regular use (representing 3/19 units, two RESPITE trial sites)( Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The lack of widespread adoption reduced staff exposure to the intervention and training opportunities.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eReported adoption of intervention among participants working clinically or linked to BUMPES and RESPITE sites.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"10\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c2\" namest=\"c1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e \u003cp\u003eBUMPES intervention reported in regular use\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c10\" namest=\"c7\"\u003e \u003cp\u003eRESPITE intervention reported in regular use\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eUnknown / Not applicable*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003eUnknown / Not applicable*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c10\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eParticipant linked to original study site\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"10\"\u003e* 3 clinical academics were no longer practicing clinically\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eMidwives need to be trained in monitoring and looking after women with remifentanil, to be familiar with it\u0026hellip; if this is a technique that you\u0026rsquo;re only reserving for women with a contraindication to an epidural, are you then facing a situation where you have staff who are not that familiar with it suddenly doing it in a thrombocytopenic woman.\u003c/em\u003e RB07 Anaesthetist non-trial site\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eWomen\u0026rsquo;s experiences\u003c/h2\u003e \u003cp\u003eParticipants widely reported that women did not receive information about interventions, for example posters and antenatal classes promoted upright labour position, and leaflets did not include remifentanil. Participants described how women\u0026rsquo;s positive or negative experiences of the interventions during the trials influenced subsequent adoption.\u003c/p\u003e \u003cp\u003e \u003cem\u003eWomen who had been in the [RESPITE] trial with their first pregnancy\u0026hellip; it was getting such good feedback, and the number of women coming back and saying \u0026ldquo;Can I have it again?\u0026rdquo; was big.\u003c/em\u003e RB09 Academic\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eThe trial and intervention context\u003c/h2\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eTrial dissemination and implementation efforts\u003c/h2\u003e \u003cp\u003e Findings from both trials were published in high-impact peer-reviewed journals, though at the time of data collection they did not feature in national guidelines. It was suggested that academic outputs did not reach many clinicians.\u003c/p\u003e \u003cp\u003e \u003cem\u003eI personally don\u0026rsquo;t think that midwives read the BMJ any more than an obstetric anaesthetist would. I think the journal was wrong. Even though it\u0026rsquo;s a really high impact journal and that\u0026rsquo;s what we aim for.\u003c/em\u003e RB29 Anaesthetist non-trial site\u003c/p\u003e \u003cp\u003eBUMPES was published in \u003cem\u003eMidwives\u003c/em\u003e journal. Dissemination also included sending summaries and posters to trial sites, presentations at national and international conferences, and a BUMPES celebration event. Participants suggested that dissemination should focus on collaboration and include support from external peer organisations.\u003c/p\u003e \u003cp\u003eWhile there were examples of implementation activities (for example a \u0026lsquo;BUMPES champion\u0026rsquo; in one site encouraged and reminded midwives to offer women lateral position in second stage), participants articulated a need for more work to translate evidence into practice. This was a general issue rather than specific to RESPITE and/or BUMPES.\u003c/p\u003e \u003cp\u003e \u003cem\u003eYou\u0026rsquo;re not going to reap the benefits of that investment in the trial unless you change practice. So I think it\u0026rsquo;s quite a big issue about wasted resources, and research waste, which is such a big issue. If we do all this really well conducted research and then don\u0026rsquo;t implement the findings, then all that investment was pointless.\u003c/em\u003e RB03 Academic\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003eInvolvement in the trials\u003c/h2\u003e \u003cp\u003eBeing a trial site provided clinicians with a head-start with resources, training and exposure to the interventions compared to non-trial sites.\u003c/p\u003e \u003cp\u003e \u003cem\u003eFor a unit which didn\u0026rsquo;t recruit into the trial, who are trying to introduce something entirely new, however well evidence-based, that as well as the fact that resources are so difficult\u0026hellip;I could quite understand why they just hold up their hands and saying, \u0026ldquo;We can\u0026rsquo;t do this, it\u0026rsquo;s just not possible.\u0026rdquo;\u003c/em\u003e RB20 Academic\u003c/p\u003e \u003cp\u003eHowever, trial participation was not a guarantee of sustained practice, with delays between study end and reporting, and limited influence and involvement of researchers in clinical areas.\u003c/p\u003e \u003cp\u003e \u003cem\u003eWe sadly because of the hiatus\u0026hellip;it [practice] didn\u0026rsquo;t change I would say, but partly it\u0026rsquo;s because we don\u0026rsquo;t have a remit within the clinical research team about evidence implementation.\u003c/em\u003e RB08 Academic\u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eIndividual clinician motivation\u003c/h2\u003e \u003cdiv id=\"Sec26\" class=\"Section4\"\u003e \u003ch2\u003eCompeting priorities\u003c/h2\u003e \u003cp\u003eRESPITE and BUMPES interventions had to be balanced with women\u0026rsquo;s needs and preferences, and clinical and administrative responsibilities. Implementing research findings was challenging in a context of competing priorities, including national safety and quality initiatives.\u003c/p\u003e \u003cp\u003e \u003cem\u003eI think most people just go \u0026ldquo;Gosh we ought to do everything\u0026rdquo;\u0026hellip;it is also led by things we have to do like CQC [Care Quality Commission reporting] and Ockenden [recommendations to improve maternity safety], and we become so full of change that research sometimes can fall to the bottom of that pile. RB13 Obstetrician non-trial site\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003ePerceptions and beliefs about the intervention and trial findings\u003c/h2\u003e \u003cp\u003eIt was suggested that individual clinicians varied in their willingness to change established routines and practices. Some clinicians additionally perceived trial effect sizes as small, that single trials had limited relevance, or were sceptical about the validity of results. BUMPES evidence was considered challenging as it contradicted strongly held beliefs about the role of gravity in labour.\u003c/p\u003e \u003cp\u003e \u003cem\u003eYou think that is the right answer, and when something goes against that idea\u0026hellip;there\u0026rsquo;s a very, very big fixed paradigm, and then quite a small effect, and it\u0026rsquo;s one trial. RB01 Academic\u003c/em\u003e \u003c/p\u003e \u003cp\u003ePolarised views regarding the safety of remifentanil were reported. Some clinicians cited fear and anxiety regarding remifentanil use with concerns about safety, and the confidence, competence and resources required to care for women using it. It was suggested that this could be tackled through training and exposure to the intervention.\u003c/p\u003e \u003cp\u003e \u003cem\u003eThe staff I think were nervous\u0026hellip;they think people are going to go into respiratory arrest at the drop of a hat. Of course that hasn\u0026rsquo;t happened because the dose is so low, and the controls are in place\u0026hellip; there\u0026rsquo;s training around its confidence of course.\u003c/em\u003e RB14 Midwife RESPITE site\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cdiv id=\"Sec29\" class=\"Section2\"\u003e \u003ch2\u003eMain Findings\u003c/h2\u003e \u003cp\u003eRESPITE 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\u0026rsquo;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).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStrengths and Limitations\u003c/h3\u003e\n\u003cp\u003eTo 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 \u0026lsquo;insider\u0026rsquo; status enabled open discussion, it may have influenced participants\u0026rsquo; willingness to share negative views, and the researchers\u0026rsquo; 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.\u003c/p\u003e \u003cdiv id=\"Sec31\" class=\"Section2\"\u003e \u003ch2\u003eInterpretation\u003c/h2\u003e \u003cp\u003eThe data provides evidence that our initial impression was correct: neither intervention was widely adopted or sustained. Publication does not guarantee adoption,(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan additionalcitationids=\"CR19\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) and the many generic barriers to evidence-based practice are also well-known.(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) 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,(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) 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.(\u003cspan additionalcitationids=\"CR23\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) While research active organisations more readily adopt evidence,(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) 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.(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) 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(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). RESPITE and BUMPES interventions are complex, and increasingly, process evaluation is undertaken alongside complex intervention trials to interrogate implementation.(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e Additional \u0026lsquo;generic\u0026rsquo; implementation barriers, included shortages of staff, equipment and drugs, training and support, and gaps in guidelines, policies and patient information.(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) The study was conducted following the COVID-19 pandemic at a time of low morale and staff shortages.(\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e) 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.(\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eOur study highlights how individual practitioner, intervention and organisational context and policy are critical,(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) 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(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Where effectiveness is not enough to change practice, trials might have to be designed to demonstrate safety.(\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e) 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,(\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). 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.\u003c/p\u003e \u003cp\u003eIt 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.(\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e) Some may be cautious to immediately adopt trial findings before clinical guidelines are updated.(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) 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) \u003cem\u003eIntrapartum Care\u003c/em\u003e guidelines(\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e) added recommendations from both BUMPES(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) and RESPITE(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e), 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 \u0026lsquo;ongoing pain relief during labour and birth\u0026rsquo;.(\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e Even where evidence-based guidelines and policy are mandated, substantial challenges must be overcome, and they may not be implemented.(\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e) 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.(\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eAs in other areas of healthcare,(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) UK maternity services are required to adopt many interventions(\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e) 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.(\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e) Cognitive overload is linked to burnout, errors and poor outcomes.(\u003cspan additionalcitationids=\"CR42\" citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e) 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,(\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e) incorporating time considerations into guidelines(\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e) and de-implementation of low-value interventions and policies(\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e). Consolidating and prioritising interventions may simplify the task for clinicians. NHS England produced a maternity and neonatal delivery plan in response to calls for \u0026ldquo;\u003cem\u003eOne clear plan that looks to encompasses the recommendations from various reports\u003c/em\u003e.\u0026rdquo;(\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e) 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.\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThis study identified maternity trials with compelling findings were not implemented widely, for reasons documented extensively in implementation science literature. It also indicates single trials may have limited capacity to change practice in the context of evidence-based guidelines underpinned by synthesis of multiple studies. Maternity professionals must navigate and prioritise ever-growing policy, guidance and research recommendations amid quality and safety scrutiny, while tailoring increasingly stretched services to local populations and service contexts. Rigorous, theory-based implementation work must be embedded throughout the maternity research cycle and in practice. However, researchers and policymakers have a duty to deliver evidence and guidance that is realistic and balanced, to support clinicians to prioritise care delivering the best outcomes for women and babies, including de-prioritisation and de-implementation. Further work is required to understand how this can be achieved.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eSupporting information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis can be found online at the end of the article: Appendix S1. Topic guide for participants\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eCRediT roles:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFCS: Formal analysis; Methodology; Project administration; Writing - original draft; Writing \u0026ndash; review and editing\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eND: Methodology; Formal analysis; Writing \u0026ndash; review and editing\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSK: Conceptualization; Funding acquisition; Writing - review \u0026amp; editing\u003c/p\u003e\n\u003cp\u003eRL: Conceptualization; Writing \u0026ndash; review and editing\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBT: Conceptualization; Methodology; Formal analysis; Writing - original draft; Writing \u0026ndash; review and editing\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll authors read and\u0026nbsp;approved the final article.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank all the clinicians and academics who took time out of busy workloads to participate in interviews and share experiences and views with us. Thanks also go to Professor Katie Morris who kindly read and commented on the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eFunding information\u0026nbsp;\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis work was funded by the National Institute for Health Research (NIHR) grant 970014 through the\u0026nbsp;Applied Research Collaborative (ARC) West Midlands (Maternity Theme)\u0026nbsp;programme. They had no role in the study design, collections, analysis, interpretation of data, in the writing of the report or in the decision to submit the article for publication. The views expressed are those of the authors and not necessarily of the NHS, the NIHR or the Department of Health.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eConflict of Interest statement\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests relating to the study. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analysed during the current study are not publicly available as\u0026nbsp;the authors did not seek ethical permission from the participants, nor the ethics committee, for the data to be used for anything other than this particular research study. The authors therefore do not have explicit permission for data sharing, so would be inappropriate and unethical to make them available in the public domain.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was obtained from the University of X Research Ethics Committee for the study (ERN_2022-0350) on 26.10.2022. Informed written or recorded verbal consent was obtained prior to interview. Participation was clearly stated as voluntary, consent could be withdrawn at any time during the research process and all participants were anonymised.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBauer MS, Kirchner J. Implementation science: What is it and why should I care? 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Nat Med. 2022;28:1331\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRothschild JM, Landrigan CP, Cronin JW, Kaushal R, Lockley SW, Burdick E, et al. The Critical Care Safety Study: The incidence and nature of adverse events and serious medical errors in intensive care. Crit Care Med. 2005;33(8):1694\u0026ndash;700.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJohansson M, Guyatt G, Montori V. Guidelines should consider clinicians\u0026rsquo; time needed to treat. BMJ. 2023;380:e072953.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIngvarsson S, Hasson H, von Thiele Schwarz U, Nilsen P, Powell BJ, Lindberg C, et al. Strategies for de-implementation of low-value care\u0026mdash;a scoping review. Implement Sci. 2022;17:73.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNHS England. Three year delivery plan for maternity and neonatal services. 2023.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Implementation science, Maternal health services, Obstetric analgesia, Obstetric labor","lastPublishedDoi":"10.21203/rs.3.rs-4311561/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4311561/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Implementing research evidence into clinical practice is challenging. This study aim was to explore implementation of two intrapartum trials with compelling findings: BUMPES (position in second stage of labour in nulliparous women with epidural), and RESPITE (remifentanil intravenous patient-controlled analgesia).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: A qualitative interview study set in UK National Health Service Trusts and Universities. Purposively sampled investigators from RESPITE and BUMPES trials and clinicians providing intrapartum care: midwives, anaesthetists, and obstetricians, were recruited using existing networks and snowball sampling. Semi-structured virtual interviews were conducted. Thematic analysis was underpinned by Capability Opportunity Motivation Behaviour Change Framework.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Twenty-nine interview participants across 19 maternity units: 11 clinical academics, 10 midwives, 4 obstetricians, 4 anaesthetists. Most (25/29) were aware of one or both trials. BUMPES had been implemented in 4/19 units (one original trial site) and RESPITE in 3/19 units (two trial sites). Access to sufficient resources, training, exposure to interventions, support from leaders, and post-trial dissemination and implementation activities all facilitated uptake of interventions. Some clinicians were opposed to the intervention or disagreed with trial conclusions. However competing priorities in terms of staff time and a plethora of initiatives in maternity care, emerged as key barrier to implementation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: Compelling trial findings were not implemented widely, and numerous barriers and facilitators were identified. Large-scale improvement programmes and evidence-based national guidelines may mean single trials have limited potential to change practice. There is a need to examine how intervention implementation is prioritised to optimise safety outcomes in the context of workforce restrictions, limited resources and large arrays of competing priorities including statutory requirements, that have increased in maternity care.\u003c/p\u003e","manuscriptTitle":"Exploring implementation of intrapartum trial evidence: a qualitative study with clinicians and clinical academics","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-23 12:46:31","doi":"10.21203/rs.3.rs-4311561/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2024-05-15T09:59:47+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-05-15T01:27:44+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-24T05:15:34+00:00","index":"","fulltext":""},{"type":"submitted","content":"Implementation Science Communications","date":"2024-04-23T07:09:05+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1e81df72-2d8d-4bdf-afa1-20f54993c24d","owner":[],"postedDate":"May 23rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-09-30T16:15:29+00:00","versionOfRecord":{"articleIdentity":"rs-4311561","link":"https://doi.org/10.1186/s43058-024-00647-z","journal":{"identity":"implementation-science-communications","isVorOnly":false,"title":"Implementation Science Communications"},"publishedOn":"2024-09-27 15:58:06","publishedOnDateReadable":"September 27th, 2024"},"versionCreatedAt":"2024-05-23 12:46:31","video":"","vorDoi":"10.1186/s43058-024-00647-z","vorDoiUrl":"https://doi.org/10.1186/s43058-024-00647-z","workflowStages":[]},"version":"v1","identity":"rs-4311561","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4311561","identity":"rs-4311561","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}