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Received: 21 February |0Revised: 3 August 2|2Accepted: 6 October 2022 DOI: 10.1111/birt.12685 OR IGINAL ART IC L E Breech specialist midwives and clinics in the OptiBreech Trial feasibility study: An implementation process evaluation Tisha Dasgupta MSc 1 Sarah Hunter 1,2 Sharna Reid 1,3 Jane Sandall CBE PhD 1 | | | | Andrew Shennan OBE FRCOG 1 | Siân M. Davies MSc 1 | Shawn Walker PhD 1,4 1 Department of Women & Children's Health, School of Life Course Sciences, Abstract Faculty of Life Sciences & Medicine, Background: Attendance of skilled and experienced professionals at breech King's College London, London, UK 2Independent Lay Members of the births has been associated with a reduction in adverse perinatal outcomes. We aimed to determine whether United Kingdom National Health Service (NHS) Research Team, Peterborough, UK 3Independent Lay Members of the sites could reliably provide attendants with OptiBreech training and/or advanced Research Team, London, UK proficiency (intervention feasibility) and consistent care (fidelity) that meets 4 Chelsea and Westminster Hospital women's needs (acceptability), with low neonatal admission rates (safety) and NHS Foundation Trust, Women's and recruitment adequate to support a clinical trial (trial feasibility). Children's Services, London, UK Methods:Mixedmethodsimplementationevaluationwasused.Settingswere13 Correspondence services in England and Wales. Participants were 82 women requesting support Shawn Walker, PhD, Department of Women & Children's Health, School of for a vaginal breech birth (VBB) at term. Outcomes were descriptively analyzed. Life Course Sciences, Faculty of Life Twenty-one women were interviewed, and transcripts were analyzed using the Sciences & Medicine, King's College Theoretical Framework of Acceptability. Iterative analysis informed subsequent London, St Thomas' Hospital, 10th interviews and the ongoing process of implementation across sites. Floor North Wing, London SE1 7EH, UK. Results: Although we initially suggested multidisciplinary teams, actively re- Email: shawn.walker@kcl.ac.uk cruiting Trusts yielded services where VBB care was provided through a dedi- Funding information cated clinic, organized and delivered primarily by a lead midwife who functioned National Institute of Health Research, as a specialist. This model achieved 87.5% fidelity with the intervention's goal of Grant/Award Number: NIHR300582; ensuring the attendance of OptiBreech-trained professionals. Neonatal outcomes NIHR Applied Research Collaboration South London (NIHR ARC South remained stable, with an admission rate of 5.5%. Women reported care from spe- London) cialist midwives as highly acceptable, but the model is vulnerable without a stra- tegic effort to develop additional proficient team members. Conclusions: Dedicated clinics coordinated by specialist midwives appear to be an acceptable and feasible implementation strategy to test the safety and effec- tiveness of proficient team care for VBB in a clinical trial. Back-up arrangements should be maintained while additional members of the team develop proficiency. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2022 The Authors. Birth published by Wiley Periodicals LLC. Birth. 2022;00:1–10. wileyonlinelibrary.com/journ|l/birt 2 2 DASGUPTA et al. 5 | x 0 D w KEY WORDS o d breech clinics, breech presentation, breech teams, feasibility, implementation, specialist d m midwives, vaginal breech delivery h p / l e b r 1 INTRODUCTION 2.1 Ethics w | | e c m “Physiological breech birth” is an approach to facilitat- The study was reviewed and approved by the East of o 1 ing vaginal breech birth (VBB) centered on the optimiza- England—Cambridgeshire and Hertfordshire Research . 1 tion and restoration of normal physiological processes to EthicsCommittee(20/EE/0287,IRAS268668).Prospective i 1 1 achieve a safe outcome. This includes upright maternal consent was obtained from all participants, except when 6 5 birth positions, such as kneeling, which promote active breech presentations were diagnosed in labor. In these y 2,3 e maternal movement and efficiency during expulsion. cases, consent was obtained after the birth. , i Interventions are performed in response to specific clin- y n ical indications based on evidence of what is considered n 4–6 L “normal” breech birth physiology. Neither upright ma- 2.2 | Quantitative data and analysis r y ternal positioning nor this approach has been tested in a n 2 clinical trial. Quantitative data included recruitment figures, demo- 0 Before a trial can be conducted, the ability to reliably graphic data, fidelity criteria (Table 1), and neonatal ad- 2 2 deliver the intervention needs to be established. The missions. Although all UK birth professionals have basic . e OptiBreech 1 study was designed to evaluate whether annual mandatory training in VBB, proficiency criteria h T services could reasonably ensure professionals with were based on previously published research and as- r s OptiBreech training and/or proficiency were able to at- sessed by local breech leads. We originally aimed for d C tend VBBs (intervention feasibility) and provide consis- >90% of births attended by someone who fulfilled the d i tent care (fidelity), in a way that is acceptable to women proficiency criteria, but this was an unrealistic short-term s h and staff (acceptability), while maintaining low neona- goal given the low levels of baseline experience in most p / tal admission rates (safety). We also aimed to examine l e whether women would participate in such a study (trial TABLE 1 OptiBreech 1 fidelity and proficiency criteria r y feasibility). Fidelity criteria for this portion of the study included: w y The purpose of a process evaluation to inform trials o • Attendance of someone who completed the OptiBreech / of complex interventions is to understand the effects of training package; r s implementing a new intervention and the mechanisms • Attendance of someone who met the advanced proficiency n of these effects in new contexts. 7–9 OptiBreech 1 was a c criteria; n noninterventional study, after women who requested i • Whether or not maternal movement and effort were used as a s a planned VBB at term under current guidelines. This o first intervention before hands-on assistance; W study focuses on the analysis of data concerning the l • Whether or not the birth was complete within 5 minutes of y models of service delivery and their acceptability to care n the birth of the fetal pelvis; and e recipients. i • Maternal birthing position a y Proficiency criteria were based primarily on Standards for r u maternity care professionals attending planned upright s 2 | METHODS vaginal breech births, Deliberate acquisition of competence f e in physiological breech birth: A grounded theory study, 32 O A We used a concurrent mixed methods design to evalu- and Expertise in physiological breech birth: A mixed i 31 e ate the implementation of OptiBreech-trained birth methods study. r g attendants in these settings. Quantitative data were These included: v n used to describe recruitment figures and outcomes. • Completion of the OptiBreech training package; d Qualitative data were used to understand how, why, y • Attendance of at least 10 VBBs including complications; e and for whom the OptiBreech Care intervention was a • Attendance of 3 VBBs within the past year; i working. We integrated these insights to refine the b • Contributing to clinical teaching; and C program theory around service delivery in our complex e • Reflective reviews of births attended i VBB intervention. e m m n L e e 1 2 DASGUPTA et al. | 3 3 x , o n centers. Following early discussion with sites, this was They also commented on those identified by other mem- o e modified to >90% of births attended by someone who had bers of the research team. Matrix and cross-tabulation fea- r completed the OptiBreech training, while continuing to tures within NVivo were used to compare results across m h also aim for proficient attendants. A detailed description demographic categories and to observe how recurrent s o of the training package has been published with previ- themes interacted with the TFA component constructs. i 10,11 i ous evaluations. Participants were counseled accord- Analytic memo writing, reflective meetings among the a . ing to their local guidelines based on the Royal College research team, and open meetings with stakeholders to l 12 . of Obstetricians and Gynaecologists guideline, supple- discuss emerging results were used to refine the findings. m d mented by a bespoke Participant Information Sheet (PIS). When the centrality of the breech-lead midwife's role 1 1 Quantitative data were obtained from individual Case in each setting became apparent, we also refined our topic Report Form (CRF) and Vaginal Breech Birth Pro Forma guide to include an exploration of this role, as understood b . completed by local investigators and analyzed descrip- by our participants.The topic guide we used is available in 6 5 tively using IBM SPSS statistical software, Version 27. the Supporting Information. y e The aim of this study was to determine the feasibility , i of ensuring OptiBreech trained and/or proficient care for y n VBBs.We collected only basic outcome data. For maternal 2.4 | Program theory n L outcomes, this was focused on the mode of birth. For neo- r y natal outcomes, we collected only neonatal death (up to Clinical trials of complex interventions should articulate a n 28days) or immediate admission to a neonatal intensive program theory for how the complex intervention works, 2 0 care unit. All neonatal admissions immediately after birth which can be summarized in a logic model. Refining the 2 3 were considered serious adverse events (SAEs), reported program theory is an important component of feasibility . 7 e to the CI, and reviewed carefully with the Study Steering work. Rather than dictate how sites should achieve the h T Committee for oversight. proficient team attendance criteria, given the significant m a A copy of the CRF, Pro Forma, and PIS are included in uncertainties in the current clinical and research context, d o Supporting Information. we elected instead to observe our participant sites' own i o strategies, how these varied across sites, and how they re- ( lated to our key outcomes. We then used these observa- t : 2.3 | Qualitative data and analysis tions to refine our program theory. n n Our original logic model included “funding for team b r Qualitative data included semi-structured interviews, training” as one of the key OptiBreech inputs. As our fea- w e lasting 37minutes on average (range 15–52minutes). sibility testing progressed, it was evident that this was not c m A care recipient-specific interview guide, based on the working as intended. The OptiBreech 1 protocol recom- e s Theoretical Framework of Acceptability (TFA), was mended that an initial multidisciplinary team (MDT) of n 13 c used. Interviews were conducted by means of Microsoft 10, including 5 obstetricians and 5 midwives, complete n Teamsbyanonclinicalmemberoftheresearchteamexpe- the in-person physiological breech birth training program, i s rienced in qualitative research (TD) and then transcribed. and funding was set aside to back-fill staff time to at- o W Two interviews were conducted by the Chief Investigator tend. However, the need for social distancing precautions e O (SW). A maximum variation purposeful sampling strategy during the COVID-19 pandemic and the effects on staff- l 14 e was used. Participants included 21 women across seven ing levels created a context in which this was impossible i a sites. Their experience included 12 VBBs (one diagnosed for all but two sites to achieve. To adapt to the new con- f r in labor), 1 forceps breech birth (FBB), 6 cesarean births textual constraints, the training package was put online l o in labor (ILCB), and 2 CBs before labor (PCB). Three cases (https://breechbirth.org.uk/the-training/courses/). The u involved difficulties with communication or births where localhands-ontrainingwasorganizedateachsitethrough ; A the attendants did not meet the full proficiency criteria. mandatory training and ad hoc activities, primarily led by r c Two women chose to give birth at home or in a midwife- the breech-lead midwives. s e led unit. o r Anonymized transcripts were initially coded with ref- d y erence to the TFA component constructs, using NVivo 12 2.5 | Stakeholder engagement h a qualitative data analysis software. Recurrent themes and l a patterns were compared across interviews. Nonclinician The OptiBreech Trial research team has facilitated the in- e r service user members of the team were provided with a volvement of multiple stakeholders from the start of the t sample of anonymized transcripts and supported to pro- project (https://optibreech.uk/category/ppi/). The project e o vide narrative feedback on the themes they identified. grew out of a body of evidence indicating that women who m n L e e 1 2 4 | DASGUPTA et al. 3 x , o n wish to plan a VBB do not always feel that services meet To achieve this rate, primarily midwives and a small a their needs. 15–17 We recognized a need to identify a more number of obstetricians spent an average of 3.38days e r effectivemodelofservicedelivery,incollaborationwithser- (range0–16)and6.49nights(range0–29)oncallperbirth. m t vice users. Because of concerns about low recruitment in Only one of the midwives reported receiving on-call pay- : 18,19 o previous breech trials, it was a priority that our method ments for planned breech births, but all were paid bank n i of testing is acceptable to women currently using maternity hours for time spent at breech births, which also provided a w services. Service users valued accurate effectiveness and clinical negligence insurance coverage. e c safety data. They also favored the development of a model m ofcarethatreliablysupportsinformeddecision-makingand o 1 the autonomy of the birthing person, rather than a model 3.3 | Mode of birth . 1 that promoted CB, VBB, or external cephalic version (ECV) i 1 as the “best” option. This priority informed our decision to Mode-of-birth outcomes are presented in Table 3. Eleven 6 5 study the experiences of women and birthing people who women changed their minds and requested a planned CB. y s activelysoughtoutaVBB,ratherthanrandomizingwomen These are removed in the central column, which repre- W l to one mode of birth or the other. Stakeholder engagement sents the final intention to treat by planned VBB sample. y in analysis and interpretation was facilitated through regu- In the final column, we removed all PCB to identify the n e lar online meetings with the OptiBreech Patient and Public rate of in-labor CB among women who began labor plan- i a Involvement(PPI)group.Thesewereadvertisedbyemailto ning a VBB. y n participants by means of the OptiBreech website and blog 3 4 and relevant social media channels. 0 ] 3.4 | Fidelity S t e 3 RESULTS As indicated in Table 4, fidelity criteria were more often r | s met when OptiBreech-trained and/or fully proficient at- n C 3.1 | Recruitment rates tendants were present. n i s h Between February 2021 and June 2022, 82 women re- s o quested a vaginal breech birth and were recruited to the 3.5 | Safety i l study across 13 sites (Table 2). Recruitment rates varied r y significantly, ranging from 1 to 14 women, and study set- Among planned VBBs, there were four neonatal admis- i up times were heavily affected by COVID-19 pressures. sions (4/73, 5.5%) and no neonatal deaths. The neonatal y o The four highest-recruiting sites each had a breech-lead admission rate among actual VBBs was 3/40, 7.5%. In two t m midwife who was formally enabled to lead the service cases, the decision made together with the Study Steering a d as part of her role and enabled to work flexibly to attend Committee was to pause the site until further in-person o i mostbreechbirthsthatoccurred.Inthesesettings,recruit- trainingcanbeprovidedtotheteam.Inonecase,abreech- n ) ment averaged 1 woman/month. A total of 16/82 (19.5%) lead midwife had not been identified before the birth; this n i women self-referred to the study from another hospital to was required before progressing further in the study. y access this model of care. To assess whether the initiation of OptiBreech team n n care would introduce a risk of poorer outcomes, we also L r identified the neonatal admission rate in five of our par- y r 3.2 | Intervention feasibility ticipating sites before the start of the study. During the u s 2years preceding the start of OptiBreech 1, these five sites f e We achieved 87.5% (35/40) of births attended by a profes- admitted8/61(13%)neonatesafterVBBs,andoneof these O a sional who had completed OptiBreech training. Three of babies died.The rate of neonatal admissions afterVBBs in c the remaining births were precipitous, and OptiBreech- OptiBreech 1 of 3/40 (7.5%) is encouraging for a future, s e trained providers did not have time to attend; in two more substantive study. o e cases,noonewhohadcompletedtheOptiBreechtraining e b was called. A provider who met the full proficiency crite- h a ria was present at 27/40 (67.5%) births. Three of the four 3.6 | Acceptability p a neonatal admissions occurred following a birth where a e r provider who met the proficiency criteria was present, Analysisofourinterviewswithwomenrevealedthreepiv- t so were not attributable to failure to ensure experienced otalneedsforbreechcareinlatepregnancy.Meetingthese e o attendance. needs made care acceptable to women and led to higher m n L e e 1 3 DASGUPTA et al. | 5 6 , g D i w s r g i o a t i t e s e m F a n t r e r a s F d p i m s t / e g s , h t a l n d i c me e / t a n a n t o g r l a u a t p S t i l e e e I t a e I o i I i r o e P d o d m n P s r P o y n f r s f s c n r e t r i l r e e c t c u a e d T e y . h s s e s e o t r s a F s p m O + O S S O O e o s 0 h 1 a / s h t l t 2 i s 5 e l l l l a a a a e y s e a a a a m m m m o e h i r r r r o o o o s W e w o o o o n n o o n o o o n o e r i F F F F I I N N I N N N I v O B m r i . e a b t y c n c a a s s a 3 f a? t t o o e 4 o g d d v v r 0 - i S S S t t S r o o r o o o t ] c i B B B S S B P N N P N N N y e F tr d h d T v m r a s d d w n t y t c c s s o s o o o o o o o o o d . s d i Y Y N Y N N N N N N N N N d n h e l t i s D c e r o r d n p ec b s a r e A n w p m e y g e t o r t y d t e o 5 5 7 u e m A m 1 1 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 S p a f m - w c n e i l i o m i s s i o n t i i W s n e h y i o 8 8 1 8 3 3 1 1 1 1 1 5 4 9 4 0 0 s a n i M 1 1 c oh n e e h L c b s a r a e f h t r m r c e n e e i n m f d i a t s n a r b d O s o c e a a r T re 1 8 1 6 4 4 3 9 8 3 5 6 4 1 3 3 8 9 7 t d c g i a s f f y e n s t o e w e n i B B g t d u C t C n o y c ( n ( a r e R d s d t s p i i i - e a 2 m l m l d t e E e r e t a r r L e A B l n t l n t H e i B d - - 1 2 t a l 3 5 6 7 8 5 9 0 8 t h e M s e A C 1 1 1 1 T C P 1 1 1 1 1 1 1 1 1 T C N S a m T aB d m s c s e 2 6 | DASGUPTA et al. 5 x 0 D TABLE 3 OptiBreech 1 mode of birth w Total w/o maternal Total w/o o Total sample (%) request CB planned CB outcomes e f m Vaginal breech birth 38 (46.3) 38 (52.1) 38 (57.6) h p Forceps breech 2 (2.4) 2 (2.7) 2 (3.0) / l Cephalic birth 3 (3.7) 3 (4.1) 3 (4.5) e r Total vaginal births 43 (52.4) 43 (58.9) 43 (65.2) y w In-labor cesarean 23 (28.0) 23 (31.5) 23 (34.8) y o Planned cesarean 16 (19.5) 7 (9.6) – / i 0 Total cesarean birth 39 (47.5) 30 (41.0) 23 (34.8%) 1 1 Total 82 73 66 r 1 8 b T TABLE 4 Feasibility and fidelity criteria s W l Attendant with None present with Attendant who met None present with Total O OptiBreech training OptiBreech training proficiency criteria enhanced training sample (%) l e i Maternal birth position a y Upright 28 (80) 2 (50) 22 (81.5) 8 (66.7) 30 (76.9) n 3 Supine 7 (20) 2 (50) 5 (18.5) 4 (33.3) 9 (23.0) 4 0 Encouraged movement and effort 3 S None required 6 (17.1) 1 (25.0) 5 (18.5) 2 (16.7) 7 (17.9) e e Yes 25 (71.4) 2 (50.0) 21 (77.8) 6 (50.0) 27 (67.5) e m a No 4 (11.4) 1 (25.0) 1 (3.7) 4 (33.3) 5 (12.5) d o <5Minutes pelvis to birth i o Yes 31 (88.6) 3 (75.0) 24 (88.9) 10 (83.3) ( t No 4 (11.4) 1 (25.0) 3 (11.1) 2 (16.7) : a n Total 35/39 (89.7) 4/39 (10.2) 27/39 (69.2) 12/39 (30.7) 39 n i aBBA/unassisted birth eliminated. a w e c m recruitment rates. These were as follows: balanced infor- described the information they received from specialists e m mation, access to skilled breech birth care, and shared as balanced, detailed, and delivered in ways that met a - responsibility. We have included exemplary quotes in a their needs. This also applied to information about the n i Supporting Information table, available online (Table S1: research study. n ) Exemplary Quotes). Thiscontrastedwiththewaytheydescribedcounseling n i We identified that some breech-lead midwives fulfilled from other professionals, which they often experienced as y severalrolesreflectingtheiroperationasspecialistswithin brief and biased. Women reported that cesarean birth was n n the service, working in collaboration with breech-lead ob- often presented as a completely safe option with no risks, L r stetricians. These included counseling and clinic coordi- and many described doubts or knowing this not to be true. y o nation, communicating plans, attending breech births, This conflicted with their values, undermined their trust u s supporting less experienced team members, providing in their care team, and sometimes created conflict be- f s training, and leading service development. Interviews tween women and their partners. They also described at- O A with women indicated that these roles were understood tempting to access online information about their options; t e by the recipients of the service, who referred to them as this was described as being difficult, time-consuming, and a e “specialists” or “consultants” and often by name. laborious, with little information available about VBB, v n At the beginning of their breech care, women de- even on NHS and hospital websites. This led participants d y scribed needing “balanced information.” Clear, unbiased to express ethical concerns that counseling and publicly e counseling about their options enabled them to make available information did not always reflect the fact that a i informed decisions, which in turn gave them a sense of they had a choice about how to give birth. b e self-efficacy, choice, and control over the situation. They In sites with routine referrals to a breech specialist e i valued being fully informed about both the potential clinic and/or midwives, women experienced less conflict- e o risks and potential benefits of VBB. Women consistently ing information. Women particularly valued the breech m n L e e 1 2 DASGUPTA et al. | 7 5 x 0 D w midwives' ability to describe complications and their res- care in hospitals close to their home. Women expressed o e olution. They interpreted this as a reflection of the mid- concern that the situation raised equity of access issues, f wives' skill and experience, which they perceived could and perhaps others who lacked similar resources would m h contribute to their safety and their baby's safety. Detailed not be able to give birth the way they wanted to. s o counseling instilled confidence not only in the midwife Finally, participants who planned a VBB benefitted i l but also in themselves, with some stating that they would from “shared responsibility” with their care team. Before r y likely have had an unwanted cesarean birth without accessing supportive care, women often felt a significant i y OptiBreech guidance. Although women all reported re- emotional burden. They felt alone to bear the respon- o d ceiving information about potential risks, some reported sibility of any potential adverse events. They reported / 0 feeling doubt that the risks could apply to them. Others that other people in their lives, including professionals, 1 / reported that they particularly valued the detailed antena- family, and friends, expressed judgment of their birth t 2 tal information, especially when they or their babies expe- choices and suggested that they were perhaps being ir- 8 rienced complications. responsible. This led to feelings of guilt, selfishness, and b T “Access to skilled breech birth care” also affected wom- shame. t W en's ability to plan aVBB when they desired one.They un- For many, transferring care to the OptiBreech site e O derstoodtheimportanceof skillandexperienceinmaking meant developing a relationship with an experienced i e VBB as safe as possible and therefore perceived that this breech midwife who supported the women's choices, b r was only a reasonable option if skilled professionals were which lightened this emotional burden. Women per- o [ available. Participants found it convenient to access care ceived the specialist midwives as taking responsibility for / / when referred during their routine care. Others found it cultivating a safe-as-possible service, including accurate 2 ] difficult, even within OptiBreech sites, if they were not counseling about complications, spending time on-call e referred to an OptiBreech midwife for detailed counsel- to attend births, and training other members of the team. t T ing and planning. Women expressed reassurance when Some women focused on the breech specialist midwife in r s they perceived there was a good chance a breech specialist contrast to other members of the team in whom they did n C wouldbeattheirbirth,andthataplanwouldbeinplaceif not have confidence. But others perceived that the provi- n i not.Women who were referred to dedicated clinics valued sion of a specialist service reflected a shared commitment s h the input of consultant obstetricians who also appeared to skill development within the wider team, which they s o knowledgeable and confident about VBB. were prepared to trust, even while they understood that l e On the other hand, for some women, trust and con- not all members of the team had the same level of experi- r y fidence in specialist breech care were centered solely ence (Figure 1). i y around the breech specialist midwife. In some cases, o when the woman was not reassured that the specialist / m could attend her birth, she chose to plan a CB instead. 4 | DISCUSSION - d The focus on the breech specialist midwife rather than a o d team was especially apparent when women felt that not In contexts where women have the option of choosing to o ) all staff appeared to be aware of the service or supportive plan a VBB with an OptiBreech-trained provider, breech n W of its purpose. Even within units with a specialist clinic specialistmidwiveshavebeenacentralmechanismofser- e O and a formal role in place, services were not always fully vice delivery and maternity team skill development. This i e embedded. In multiple sites where there was no special- model of service also appears to be comparatively much b r ist clinic or breech specialist midwife, women were told more acceptable to women than standard care, especially o the service was not available; some found out later it had when obstetric colleagues are involved and supportive. r e been available, whereas others transferred to another In sites with a dedicated clinic, the model may have ad- o s OptiBreech site. ditional benefits, as this has also been shown to correlate ; 20 A Some women (19.5%) who had no access to skilled with higher ECV success rates. r l breech care locally transferred their care to an OptiBreech In this study, specialist midwives and clinics im- a e hospital;afewevenmovedtheirplaceof residencetempo- proved women's ability to plan a VBB and partici- v r rarily. Accessing specialist care for these participants was pate in research. This does not appear to be a result of d y sometimes associated with opportunity costs such as time “normality-centered care” or encouraging vaginal birth h 21 p off work, financial costs, traveling long distances to the “at all costs.” Our findings suggest that when women l b hospital, additional trips, and a lack of antenatal continu- aregivenclearandbalancedinformationaboutrisksand e ity they would have received in local care. However, many benefits, and there is a high likelihood of having skilled e i were happy to make the increased effort because they had and experienced support at their birth, more women feel e o chosen to plan a VBB, and they could not access skilled able to express their preference to plan a VBB. This is m n L e e 5 8 DASGUPTA et al. 5 | 6 , D w n a d r m t s o i l r y w y c m o 1 1 b . 2 5 y T t W e O l e i a y n 2 0 2 2 FIGURE 1 The logic model for OptiBreech Care as of July 4, 2022, including refinements from our ongoing implementation process . e evaluation t e r s consistent with previous research 22–24 and the ethical We have focused on interviews with women in this n C principles of informed choice 25 about medical inter- analysis. Further work is needed to describe the roles of n i ventions. The women we interviewed who ultimately breech specialist midwives and to evaluate the accept- n ( t chose to plan a CB also indicated they felt supported in ability of the role among the wider MDT team. Also, : o their choice and provided with information appropri- the OptiBreech Chief Investigator fulfills multiple roles, n l ate to their needs. We have therefore incorporated spe- including service leadership and delivery. This may in- a y cialist midwives and clinics into the description of our troduce bias. To balance this, a nonclinical member of i y OptiBreech Care intervention. the team conducted and independently analyzed all in- o / We have identified a relationship between qualitative terviews. The findings were subject to member checking r s aspects of service delivery and women's preference or with participants and service user research team member n c ability to plan a VBB. We have been able to describe these feedback (SH, SR). n t features with enough detail to be replicated and tested in While the care model delivered by breech specialist n ) a clinical trial.Women's descriptions in this study are con- midwives is effective at enabling access to research, is ac- n i sistent across multiple services, despite varying outcomes. ceptable to women, and is able to achieve reasonable fi- y O Theyarealsoresonantwithpreviousresearchonwomen's delity, more time will be required for the service to embed. n 26 e experiences. The level of involvement of the OptiBreech Meanwhile, the burdens of time and responsibility on b r PPI group and service user members of our research team thesemidwivesaresignificant,andtheservicemaybevul- f r have been significant and meaningful. nerable when they are not available. This model depends l o Our study also has some limitations. Our finding that on the ability of the specialists to protect their time and u 31,32 e a model in which a dedicated clinic and OptiBreech- work flexibly to cover the service, which will require O a trained team are coordinated by a breech specialist mid- funding to be sustainable. Ongoing implementation and i e wife is the most successful implementation model does evaluation work should focus on the best way to develop a g not mean other models are ineffective. Our findings are additional proficient team members and on economic v n heavily influenced by context, including the continuing implications. Safety outcomes should be evaluated in a d y impacts of the COVID-19 pandemic on staffing levels large-scale observational study, in addition to any trial of h a within the NHS and low overall breech experience lev- comparative effectiveness. l a els in these settings after decades of erosion. Successful e C breech services involving midwives have been reported AUTHOR CONTRIBUTION a 27,28 v internationally, but other models have been reported SW,JS,andASdesignedthestudyandsupervisedthedata C 29,30 m in other contexts. analysis. TD collected and analyzed the data and drafted o s i n e 2 DASGUPTA et al. 9 5 | 6 0 D a Delphi study. Midwifery. 2016;34:7-14. doi:10.1016/j. w the first summary of results. SH and SD contributed to the l midw.2016.01.007 d analysis and interpretation. SD reviewed qualitative and 5. Reitter A, Halliday A, Walker S. Practical insight into upright d o quantitative analyses. SW finalized the manuscript and all breech birth from birth videos: a structured analysis. Birth. m p authors approved it. 2020;47(2):211-219. doi:10.1111/birt.12480 / n 6. Spillane E, Walker S, McCourt C. Optimal time intervals n for vaginal breech births: a case–control study. NIHR Open b FUNDING INFORMATION a Res. Published online September 24. 2021;2:45. doi:10.3310/ w Shawn Walker is funded by a National Institute of l nihropenres.13297.2 . Health and Care Research (NIHR) Advanced Fellowship m 7. SkivingtonK,MatthewsL,SimpsonSA,etal.Anewframework d (300582).JaneSandallatKing’sCollegeisanNIHRSenior for developing and evaluating complex interventions: update / . Investigator. Both are supported by the NIHR Applied of Medical Research Council guidance. BMJ. 2021;374:n2061. 1 / Research Collaboration South London (NIHR ARC South doi:10.1136/BMJ.N2061 t 2 London) at King’s College Hospital NHS Foundation 8. Moore GF, Audrey S, Barker M, et al. Process evaluation of 8 complex interventions: medical research council guidance. b Trust. The views expressed are those of the author(s) and T not necessarily those of the NIHR or the Department of BMJ. 2015;350:h1258. doi:10.1136/bmj.h1258 s W Health and Social Care, who played no role in conducting 9. Proctor E, Silmere H, Raghavan R, et al. Outcomes for imple- e O the research and writing the paper. mentation research: conceptual distinctions, measurement l challenges, and research agenda. Adm Policy Ment Health Serv e i Res. 2011;38(2):65-76. doi:10.1007/s10488-010-0319-7 a CONFLICT OF INTERESTS y 10. Walker S, Reading C, Siverwood-Cope O, Cochrane V. n SW is a co-Director of Breech Birth Network, a Physiological breech birth: evaluation of a training programme 3 0 Community Interest Company, that provides breech for birth professionals. Pract Midwife. 2017;20(2):25-28. 2 3 training and donated the online training package used 11. Mattiolo S, Spillane E, Walker S. Physiological breech birth . e in the study. SW receives speaking fees and expenses for training: an evaluation of clinical practice changes after a one- h day training program. Birth. 2021;48(4):558-565. doi:10.1111/ T her activities. m birt.12562 s d 12. ImpeyL,MurphyD,GriffithsM,PennaL,onbehalf of theRoyal C DATA AVAILABILITY STATEMENT d College of Obstetricians and Gynaecologists. Management of i The data that support the findings of this study are Breech Presentation. BJOG 2017;124(7):e151-e177. doi:10.1111 s h openly available in Figshare at https://figshare.com/ /1471-0528.14465 p / articles/dataset/OptiBreech_1_IRAS268668_outcomes_ 13. Sekhon M, Cartwright M, Francis JJ. Acceptability of health- l e FINAL_for_deposit_xlsx/20410971, reference number care interventions: an overview of reviews and development of b a theoretical framework. BMC Health Serv Res. 2017;17(1):88. y 20410971. w doi:10.1186/s12913-017-2031-8 e c 14. Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, m ORCID Hoagwood K. Purposeful sampling for qualitative data col- e s Tisha Dasgupta  https://orcid.org/0000-0002-7874-9519 lection and analysis in mixed method implementation re- n - Jane Sandall  https://orcid.org/0000-0003-2000-743X search. Adm Policy Ment Health Serv Res. 2013;42(5):533-544. n t Andrew Shennan  https://orcid. doi:10.1007/S10488-013-0528-Y n 15. Petrovska K, Watts NP, Catling C, Bisits A, Homer CS. “Stress, ) org/0000-0001-5273-3132 n anger, fear and injustice”: an international qualitative sur- i Siân M. Davies  https://orcid.org/0000-0001-5662-7038 y vey of women's experiences planning a vaginal breech birth. n Shawn Walker  https://orcid.org/0000-0003-3658-8988 n Midwifery. 2017;44:41-47. doi:10.1016/j.midw.2016.11.005 L 16. Petrovska K, Watts NP, Catling C, Bisits A, Homer CSE. b REFERENCES y Supporting women planning a vaginal breech birth: an in- o 1. Walker S, Scamell M, Parker P. Principles of physiological r ternational survey. Birth. 2016;43(4):353-357. doi:10.1111/ e breech birth practice: a Delphi study. Midwifery. 2016;43:1-6. o birt.12249 u doi:10.1016/j.midw.2016.09.003 17. Thompson E, Brett J, Burns E. What if something goes wrong? ; A 2. 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