Support for healthy breastfeeding mothers with healthy term babies.

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Continuity of midwifery caregiver is integral to United Kingdom maternity policy, 1,2 and various continuity schemes are being implemented in different locations nationwide. Driven partly by pregnant women's desire to know their midwife, this development also reflects growing evidence of improved clinical and psychosocial outcomes, and cost effectiveness. 3 Innovative schemes must be formally evaluated to insure they are fit for purpose. In an accompanying paper (this volume), we report how maternity care is provided in Angus, a county within NHS (National Health Service)

Background Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. Methods THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. Results THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. Conclusions Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. Trial registration International Standard Randomised Controlled Trials Number Registry ISRCTN21656568. Retrospectively registered on 28 February 2014

Background There is a lack of evidence of the effect of cue-based feeding compared with scheduled feeding on important outcomes for preterm infants. Objectives The objectives were as follows: (1) to describe the characteristics, components, theoretical basis and outcomes of approaches to feeding preterm infants transitioning from tube to oral feeding; (2) to identify operational policies, barriers and facilitators, and staff and parents’ educational needs in neonatal units implementing cue-based feeding; (3) to co-produce an intervention for feeding preterm infants in response to feeding cues; (4) to appraise the willingness of parents and staff to implement and sustain the intervention; (5) to assess associated costs of implementing cue-based feeding; (6) to determine the feasibility and acceptability of a future trial; (7) to scope existing data-recording systems and potential outcome measures; and (8) to determine stakeholders’ views of whether or not a randomised controlled trial of this approach is feasible. Design This was a mixed-methods intervention development and feasibility study comprising (1) a systematic review, case studies, qualitative research and stakeholder consensus; (2) the co-production of the intervention; (3) a mixed-methods feasibility study; and (4) an assessment of stakeholder preferences for a future evaluation. Setting Three neonatal units in the UK (two level 3 units and one level 2 unit). Participants Developmentally normal, clinically stable preterm infants receiving enteral feeds (n = 50), parents (n = 15 pre intervention development; n = 14 in the feasibility study) and health-care practitioners (n = 54 pre intervention development; n = 16 in the feasibility study). Intervention An evidence-informed multicomponent intervention comprising training, a feeding protocol, feeding assessment tools, supplementary training materials [including posters, a film and a narrated PowerPoint (Microsoft Corporation, Redmond, WA, USA) presentation] and the ‘Our Feeding Journey’ document. Main outcome measures The main outcome measures were recruitment and screening rates, infant weight gain, duration of the intervention, feeding outcomes, implementation outcomes (contextual facilitators and barriers, acceptability, adoption, appropriateness and fidelity) and stakeholder preferences for a future evaluation. Results The systematic review of 25 studies concluded that evidence in favour of cue-based feeding should be treated cautiously. The case studies and qualitative research highlighted contextual barriers to and facilitators of the implementation of cue-based feeding. The telephone survey found that many neonatal units are considering implementing cue-based feeding. We recruited 37% of eligible infants, and there was good retention in the study until discharge but a high loss to follow-up at 2 weeks post discharge. The mean number of days from intervention to transition to full oral feeding was 10.8, and the mean daily change in weight gain was 25 g. The intervention was acceptable to parents and staff, although there was dissatisfaction with the study documentation. Intervention training did not reach all staff. A cluster-randomised design with a composite outcome was suggested by stakeholders for a future study. Limitations The intervention was available only in English. Intervention training did not reach all staff. There was low recruitment to qualitative interviews and observations. Only a small number of medical staff engaged in either the training or the interviews. Conclusions It is feasible to implement a cue-based feeding intervention with improved training and documentation. Further work is needed to assess the feasibility of a future trial, noting evidence of existing lack of equipoise. Future work The next steps are to digitalise the intervention and conduct a survey of all neonatal units in the UK. Study registration This study is registered as PROSPERO CRD42018097317 and ISRCTN13414304. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 74. See the NIHR Journals Library website for further project information.

Introduction: Continuity of midwifery carer improves outcomes, but there is significant variation in how such schemes are implemented and evaluated cross-culturally. The Angus home birth scheme in Scotland incorporates continuity of carer throughout pregnancy, labor, birth, and the postnatal period. Methods: Manual maternity case note review to evaluate the 80% continuity of carer and 3% planned home birth rate targets. Results: Of 1466 women booking for maternity care, 69 joined the scheme. Fortyfour had a planned home birth (3% overall), of whom seven were originally deemed ineligible. Of the 44, eight (18%) also achieved 80% continuity of carer with the primary midwife; by including a home birth team colleague, the continuity rate rose to 73%. Women whose care achieved home birth and continuity targets had lower deprivation scores. Eligibility issues, women's changing circumstances, and data recording lapses were complicating issues. Conclusions: Targets must be both feasible and meaningful and should be complemented by assessing a broad range of outcomes while viewing the scheme holistically. By expanding eligibility criteria, the home birth rate target was met; including input from a home birth team colleague in the calculation meant the continuity target was nearly met. With dedicated and competent staff, adequate resource and political support, and when considered in the round, the scheme's viability within local services was confirmed. Other generalizable learning points included the need to standardize definitions and data recording methods. Comparability across schemes helps grow the evidence base so that the links between processes and outcomes can be identified.