The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers

Midwifery, maternity, continuity of carer, MCoC, continuity of care models, service delivery, patient safety, implementation. ALL Metrics - Views Downloads How to cite this article Milton R, Channon S, Sanders J et al. The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.13745.2) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Study Protocol Clinical trial Revised The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved] Rebecca Milton https://orcid.org/0000-0001-5985-3866 1, Susan Channon https://orcid.org/0000-0002-5394-1483 1, Julia Sanders https://orcid.org/0000-0001-5712-9989 2, [...] Sara Kenyon3, Aimee Middlemiss https://orcid.org/0000-0001-9765-717X 4, Heather Strange1, Kate Davies5, Lena Choudary-Salter6, Susan Barry7, Tina Prendeville8, Aled Jones https://orcid.org/0000-0002-2921-8236 4Rebecca Milton https://orcid.org/0000-0001-5985-3866 1, Susan Channon https://orcid.org/0000-0002-5394-1483 1, [...] Julia Sanders https://orcid.org/0000-0001-5712-9989 2, Sara Kenyon3, Aimee Middlemiss https://orcid.org/0000-0001-9765-717X 4, Heather Strange1, Kate Davies5, Lena Choudary-Salter6, Susan Barry7, Tina Prendeville8, Aled Jones https://orcid.org/0000-0002-2921-8236 4 PUBLISHED 24 Apr 2025 Author details Author details 1 Cardiff University Centre for Trials Research, Cardiff, Wales, UK 2 Cardiff University School of Healthcare Sciences, Cardiff, Wales, UK 3 School of Health Sciences, University of Birmingham, Birmingham, England, UK 4 University of Plymouth School of Nursing and Midwifery, Plymouth, England, UK 5 Tommy's Baby Charity, London, UK 6 The Mosaic Community Trust, London, UK 7 Imperial College Healthcare NHS Trust Division of Women's Children's and Clinical Support, London, England, UK 8 Imperial College London Women's Health Research, London, UK 2 Cardiff University School of Healthcare Sciences, Cardiff, Wales, UK 3 School of Health Sciences, University of Birmingham, Birmingham, England, UK 4 University of Plymouth School of Nursing and Midwifery, Plymouth, England, UK 5 Tommy's Baby Charity, London, UK 6 The Mosaic Community Trust, London, UK 7 Imperial College Healthcare NHS Trust Division of Women's Children's and Clinical Support, London, England, UK 8 Imperial College London Women's Health Research, London, UK Rebecca Milton Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Susan Channon Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Julia Sanders Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Sara Kenyon Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Aimee Middlemiss Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Heather Strange Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Kate Davies Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Lena Choudary-Salter Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Susan Barry Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Tina Prendeville Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Aled Jones Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS During pregnancy, labour and early motherhood, most women in the UK receive care from different midwives. The National Health Service (NHS) policy change in England sought to introduce a model of care whereby each woman is cared for by the same midwife throughout antenatal, intrapartum and postnatal periods, supported by a small team of midwives to cover off-duty periods. This model is called the Midwifery Continuity of Carer (MCoC). The aim of this study is proposes to evaluate the implementation and delivery of MCoC across England, aiming to better understand the factors that result in different rates of progress with MCoC implementation. To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England? A sequential mixed-methods study, informed by implementation science frameworks will be delivered over three work packages. Work package 1: Following a literature review of the challenges and successes of previous attempts to implement MCoC. Work package 2: six case studies in NHS Trusts will be undertaken to better understand different rates of progress with MCoC implementation and people's experiences of MCoC implementation through: interview and questionnaire (maternity services staff); interviews (service-users); observation of relevant implementation meetings and organisational documentation collection. Interviews will be undertaken with national and regional stakeholders relevant to MCoC implementation. Work package 3: Data analysis will be conducted both inductively and deductively, informed by implementation science constructs. Study findings will be disseminated through peer-reviewed journals, conferences and events. Results will be of interest to the public, clinical and policy stakeholders in the UK and will be disseminated accordingly. During pregnancy, labour, and early motherhood, most women in England receive care from different midwives. In 2016, NHS England introduced a policy aimed at ensuring that, by 2020, women would receive care from the same midwife (or a small team of midwives during off-duty periods) throughout their pregnancy and after birth. This model of care, called Midwifery Continuity of Carer (MCoC), has been introduced as there are strong claims that MCoC can improve the safety and quality of maternity care, especially for vulnerable women, babies, and those from minority ethnic communities or deprived areas. MCoC could also increase job satisfaction for midwives, although it might also lead to higher job-related stress and more unsociable working hours. While many midwives support the idea of MCoC, many also feel unable to implement it due to staffing shortages and other resource limitations, leading to mixed progress in England. The study aims to understand the factors influencing the varied progress of MCoC implementation across England through three linked work packages (WPs). WP1: Conduct a literature review to understand the challenges and successes of previous MCoC implementation efforts. WP2: Perform case studies in six NHS Trusts to explore different implementation rates and experiences. This includes interviews and surveys with maternity staff, service users, and stakeholders, as well as document reviews and observations of meeting. WP3: Analyse data from the case studies to identify different approaches to MCoC implementation, including associated implementation factors, barriers and enablers, and patterns in MCoC outcomes. - - Review international literature on MCoC implementation challenges and successes. - - Evaluate how MCoC has been implemented and experienced in six diverse case sites. - - Explore the role of national and regional stakeholders in MCoC implementation. - - Synthesise findings to identify key implementation factors including barriers, facilitators and patterns in outcomes. Midwifery, maternity, continuity of carer, MCoC, continuity of care models, service delivery, patient safety, implementation. Corresponding Author(s) Rebecca Milton ([email protected]) Grant information: This project is funded by the National Institute for Health and Care Research (NIHR) under its Health and Social Care Delivery Research (HSDR) programme (Grant Reference Number: NIHR151802). SK is part funded by the Applied Research Collaboration (ARC) West Midlands (NIHR200165). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Milton R et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Milton R, Channon S, Sanders J et al. The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.13745.2) First published: 16 Jan 2025, 5:4 (https://doi.org/10.3310/nihropenres.13745.1) Latest published: 24 Apr 2025, 5:4 (https://doi.org/10.3310/nihropenres.13745.2) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The changes made in this most recent version of The SIMCA Study Protocol address comments made by the three reviewers. These changes include restructuring the methods section, namely work package 2 - this is to improve readability and flow of the manuscript and the data analysis section, some detail was moved from the data collection and management section to the analysis section which is a more appropriate fit. Some minor typos and language errors were amended throughout the manuscript. The changes made in this most recent version of The SIMCA Study Protocol address comments made by the three reviewers. These changes include restructuring the methods section, namely work package 2 - this is to improve readability and flow of the manuscript and the data analysis section, some detail was moved from the data collection and management section to the analysis section which is a more appropriate fit. Some minor typos and language errors were amended throughout the manuscript. See the authors' detailed response to the review by Linda Sweet See the authors' detailed response to the review by Vidanka Vasilevski See the authors' detailed response to the review by Jane Sandall Improving newborn and maternal health has long been a leading priority of UK and global policy makers1,2. Yet safety and quality of maternity services remains problematic worldwide3. Sub-optimal care in maternity services can result in death, serious disability and profound anguish for women, their children, and their families4,5, placing significant burden on healthcare systems and infrastructure, including the costs associated with legal action6. The continuous and urgent need to enhance the quality and safety of care delivery is frequently linked to several factors, namely: multimorbidity, healthcare delivery complexities and a multitude of cultural and organisational challenges5,7. As a result, recent The National Health Service England (NHSE) policy has introduced significant changes to improve the quality and safety of maternity care2,8. Implementation of the policy for safer and more personalised care across England is currently led by the Maternity Transformation Programme (MTP), consisting of a range of inter-connected interventions, including establishing Midwifery Continuity of Carer (MCoC) models of care. MCoC aims to ensure that women are cared for by a named midwife who coordinates and personally provides the majority of care, supported by a small MCoC team (a headcount of eight midwives or fewer), throughout pregnancy, birth and the postnatal period, supported by a linked obstetrician9. Although this evidence is still evolving and the extent of clinical advantages of the model have recently changed10. However, little is known about the factors, contexts, and conditions necessary for successful implementation of policy initiatives to improve service delivery and care quality within the distinctive setting of maternity care11,12. The question of implementing change in maternity services is particularly salient given the proliferation of priorities and initiatives introduced over the last five years within the ‘maternity and neonatal safety improvement programme’, coordinated by the MTP. Healthcare settings, which have similarly experienced a surfeit of interventions, have been described as ‘policy thickets’, which are defined as dense patches of overlapping goals that command substantial attention and resources, but where policy goals are unclear and external strategies may not link to local priorities13. Policy thickets should be of particular interest to implementation research projects such as this. For example, important questions include how the implementation of each individual initiative interacts with other initiatives, such as MCoC implementation. Similarly, while each national initiative is generally well described whether they cumulatively stack-up as a coherent whole at the regional and local level, is often overlooked. The accumulation of local, regional and national maternity interventions also raises questions regarding the potential for MCoC implementation to be affected by ‘change fatigue’ within the workforce14. Questions relating to de-implementation are also relevant, such as how service leaders and other stakeholders plan and experience the redesign and decommissioning of existing services in response to new priorities. Potential difficulties and unintended consequences related to parallel and simultaneous implementation/de-implementation processes within clinical settings and teams are largely overlooked in existing research and policy15. Progress in implementing MCoC across England has been highly problematic16,17. Initial targets to deliver MCoC to the majority of women by 2021, with an interim target of 20% of women receiving MCoC by March 2019, were not met. For example, NHS statistics17 indicated that in 2020, 108 NHS Trusts offered MCoC to 15.9% of pregnant women, falling short of the interim target and significantly below the target of the ‘majority of women’. Implementation challenges were compounded by the COVID-19 pandemic, but this was not the only challenge with, a recent Health and Social Care Select Committee report rated the progress of MCoC implementation as highly variable and ‘requires improvement’17. As a result, the implementation targets for MCoC have been regularly revised. Most recent amendments to MCoC implementation policy were issued in September 202218. In response to the Ockenden report5, NHSE directed all NHS Trust Chief Executives to ‘review and suspend, if necessary, the existing provision and further roll out of MCoC’ unless they could ‘demonstrate staffing meets safe minimum requirements on all shifts.’ Targets for implementation progress were also removed. Since autumn 2022 the MTP has maintained support for expansion of MCoC wherever possible. Some NHS Trusts have successfully implemented MCoC, although the majority have partially implemented, or are yet to commence implementation. Progress with MCoC implementation is likely to remain variable for the foreseeable future, providing an opportunity to observe the challenges of implementation, as well as to describe the receptive context and the necessary conditions required for change. Unproductive implementation in healthcare can cause workforce stress and uncertainty, especially if changes lack clear communication, fairness, or appropriate speed16,19. Failed efforts can overload staff, reducing patient care quality and treatment effectiveness. Implementing change in the NHS20,21, particularly in maternity services3,22, is challenging. Studying the implementation of MCoC within this context, amidst various initiatives and operational hurdles, is crucial. While limited research exists on MCoC implementation in NHS, early evidence indicates complexity and challenges. A recent Cochrane review suggests future research should focus on understanding the implementation and scaling up of midwife continuity of care10. Evaluating local, regional and national factors relevant to MCoC implementation will inform policy discussions and improve decision-making in maternity settings in England and beyond. The aim is to explore factors influencing MCoC implementation in England, examining variations in operationalisation, sustainability, and experience. The research question is: "What factors at local, regional and national levels contribute to variable progress in MCoC implementation in NHS in England?" 1. Appraise the international literature to understand the factors contributing to the success and challenges of MCoC implementation. 2. Evaluate how implementation decisions have been operationalised, sustained and experienced in six case study sites representing contrasting progress with MCoC implementation. 3. Describe and explore the role played by national and regional stakeholders in MCoC implementation. 4. Synthesise findings to identify various approaches to MCoC implementation, key implementation factors and relationships, and any discernible patterns between implementation factors and routinely reported MCoC outcomes. MCoC is conceptualised as a complex intervention, e.g. one that comprises many inter-dependent components across multiple systems from the macro level (e.g. NHSE), to meso (e.g. Regional Midwifery Boards) and micro levels (e.g. Local Maternity Services)23. These complex organisational levels are ‘nested’24, such that each level simultaneously interacts with multiple other systems. For example, MCoC implementation will occur alongside pre-existing micro-level employee relationships and experiences, as well as the characteristics of the maternity unit (e.g., size and setting). A range of contextual and organisational preconditions also exist at the meso-level, such as organisational/managerial structures, policies, processes, and hierarchies, which can shape the local implementation. In addition, public, policy and governmental interest in MCoC adds a social and inter-institutional macro level dimension to the implementation, which may be experienced from an institutional standpoint as external social and policy pressure and risk25. Given the complex nature of MCoC implementation and the contexts within which the intervention is being implemented, Normalisation Process Theory (NPT)26,27 and the Consolidated Framework for Implementation Research (CFIR)25 offer appropriate and complementary frameworks to guide the study. NPT and CFIR are often used in combination with other theories to explore multiple facets of implementation27,28. CFIR offers numerous constructs to consider when investigating implementation of complex interventions and will be applied accordingly28. In particular, CFIR constructs focussing on the interaction between the inner and outer settings within which an intervention is implemented are useful, given the complexity and national profile of MCoC. Generally, the outer setting includes the wider national/regional economic, political, and social context within which an organisation resides, and the inner setting includes features of local organisations’ structural, political, and cultural contexts through which the implementation process proceeds25. NPT seeks to explain how complex interventions work by focusing on factors promoting and inhibiting their transformation into routine ways of working29. NPT consists of four main components, or generative mechanisms: coherence, cognitive participation, collective action and reflexive monitoring26. Since study inception there has been active involvement and engagement from patient and public members. The Patient and Public Involvement (PPI) members of SIMCA are named co-applicants on the grant and have contributed to the development of the study. There is an established PPI group which meets regularly, similarly the PPI members participate as full members of the monthly Study Management Group (SMG). The Project Advisory Group (PAG) which meets six monthly has a PPI representative as a core member. The aim of this active engagement from inception is to ensure that patient and public views are integrated throughout the lifetime of the project as well to help the research team take a broader look at the context of maternity services, trying to understand the wider system of healthcare (e.g., the interface of maternity services and primary care), how national and regional decisions and systems reflect the needs of communities and individuals, and how these might impact on MCoC. PPI members will focus on ensuring that the study is appropriately designed and delivered; e.g. contributing to developing the analysis, exploring findings and dissemination from a public/patient perspective. PPI members will also contribute directly to dissemination. Dissemination will have significant public reach through the close involvement in the project of Tommy’s Baby Charity and The Mosaic Community Trust. Preparation of research information will include input from our PPI team, to ensure culturally appropriate content is distributed. Similarly, the PPI co-applicants will provide cultural sensitivity and awareness training to all members of the research team as specialist input for those undertaking interviews with women. The project consists of the three inter-related work packages. Work Package 1: Narrative evidence synthesis The aim of work package 1 is to undertake a narrative evidence synthesis approach which addresses objective 1. We will use a textual approach to generate an interpretive synthesis of any relevant ‘theories of change’30, contextual factors and organisational mechanisms that influence (for better or worse) the implementation of MCoC.

of selected studies will be gathered into a framework informed by CFIR constructs and supplemented by NPT (such as the focus on internal and external implementation factors). The framework approach ensures that the review focusses on the factors influencing implementation of MCoC, rather than reviewing the results of MCoC interventions per se. The final stage of work package 1 will produce a synthesis of the results which will directly inform all subsequent work packages31. Work package 2: Comparative case studies and national and regional stakeholder interviews Work package 2 addresses research objectives 2 and 3. Comparative case study methodology will be used to facilitate the in-depth exploration of complex organisations, such as maternity services. This is achieved through combining a range of data collection methods, including surveys, interviews, observations and documents, with a variety of sampling techniques, to gain an in-depth understanding of the implementation factors and processes within each study site32 as well as explore the perspectives of key national and regional stakeholders on the implementation of MCoC. Case sites: We aim to conduct 90 participant interviews across the six case sites; 15 interviews per site, consisting of purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians (n=10) and women receiving care within the case sites (n=5). National and regional stakeholders: We aim to conduct up to 65 national and regional stakeholder interviews. Case sites: Six case study sites will be selected following further examination of NHSE MCoC implementation data and discussion with key MCoC implementation leads at NHSE. The purposive sampling strategy will be informed by: Consideration of the regional and geographical settings of case study sites to ensure that case studies reflect, where possible, demographic and regional differences in rural, urban, and inner-city areas of England. Identifying ‘positive deviants’, defined as ‘organisations, teams or individuals that a consistently demonstrate high performance in an area of interest’33. Positive deviance will be identified in a range of ways, including reviewing NHSE data on Trusts who have a high percentage of women placed on MCoC pathway by 28 weeks’ gestation. We will also incorporate a more rounded conception of positive deviance, by looking beyond outcome data produced by NHS Trusts. For example, we will not discount the possibility that local pockets of high performance can also exist in NHS Trusts that may have lower percentage of women placed on the MCoC pathway. National and regional stakeholders: For the purposes of this study, we define stakeholders as individuals and/or organisations who directly affect, or are affected by, MCoC implementation. National and regional stakeholders can have considerable influence over MCoC implementation by directly controlling resources and informing/taking key decisions. Individuals will be purposively sampled to recruit respondents with knowledge of MCoC, and/or involved in policy/strategy implementation. Potential participants include those contributing to MCoC and MTP implementation nationally within NHS (E/I) and NHS Health Education England (HEE). Stakeholders will be identified, contacted and recruited via accessing publicly available information from professional bodies (e.g. Royal Colleges), third sector organisations (e.g. Maternity Action), national and regional NHS representative bodies and national maternity voices programme (who support the co-production of maternity and neonatal services with service-users) for example. Regional NHS stakeholders will be geographically linked to the location of each case site and are likely to include representatives from regional maternity boards and regional MCoC and workforce planning leads. The research team’s extensive existing networks will also be utilised and referral from those contacted or recruited using the above methods. Case sites: Access to undertake fieldwork in the case study sites will be negotiated with local stakeholders/sites. In each case study, data will be generated via: Observations: researchers will undertake guided non-participant observations at MCoC implementation meetings and related activities at each case site. Local documentation and data: The researchers will access local documents via the stakeholders. These may include: Routinely collected MCoC implementation data. Anonymised patient safety data (e.g. serious incidents and events reports, staff concerns via Staff Speak Up). Local documents (for example, MCoC operational policies and service specifications). MCoC service use. Completed local audits and/or evaluations. Related grey literature. Staff survey: a validated staff survey tool (NOMAD)34 will be used to collect the perceptions and experiences of maternity staff about the implementation of MCoC in the maternity services within which they work. Descriptive analysis of the survey responses will initially explore how answers are distributed. In line with the guidance provided by the tool’s creators34, total scores for the survey will not be calculated. Recorded semi-structured interviews in six case study sites (n=c.90): At each case site semi-structured interviews (n=15) will be conducted with purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians (n=10) and women receiving care within the case sites (n=5). Interview schedules will be informed by the staff survey findings, in addition to views of the PAG and PPI team, the findings of the narrative synthesis and the application of CFIR and NPT via their respective toolkits35,36. Questions will be included on: How services are organised and delivered. Any effect on implementation of the interplay between the ‘outer domain’ (regional and national priorities and incentives) and the ‘inner domain’ (maternity services). Organisational readiness and the ‘implementation climate’ related to MCoC. The coherence of MCoC implementation to staff and women. Resources allocated to embedding and sustaining the MCoC model of care. The effect of MCoC on other maternity services and how existing services are decommissioned/de-implemented. All participants taking part in interviews will be offered the choice of online applications (e.g., MS Teams) or face-to-face and recorded with permission. Interviews will be transcribed in full by an authorised external transcription company. National and regional stakeholders: Recorded semi-structured interviews (up to 65): Candidate questions and interview schedules will be prepared as outlined above for case study interviews, with a particular focus on regional and national decision-making, implementation and de-implementation strategies and boundary working with local maternity settings. All participants taking part in interviews will be offered the choice of online applications (e.g., MS Teams) or face-to-face and recorded with permission. Interviews will be transcribed in full by an authorised external transcription company. Thematic analysis of qualitative data sources, underpinned by methodological rigour36, will be undertaken by the core project team, concurrent with data collection in each case site. NPT and CFIR constructs will iteratively inform each step of the analysis to provide rich understanding of the operational context and implementation of MCoC. Separate analysis of each case study and the regional and national stakeholder interviews will commence with data familiarisation, initial inductive and theoretical coding drawing on findings from work package 1, and the identification of themes. All analysis will be overseen by a senior researcher. Other members of the team, including the PPI members, will also periodically review transcripts to ensure consistency and contribute to analysis via online and face-to-face team meetings. The combined work package 2 analytic process will involve: Using the latest version of the NVivo qualitative data analysis software (https://lumivero.com/products/nvivo/) and SPSS (www.ibm.com/spss) for the survey data to organise and store data ready for analysis. In-depth and iterative familiarisation of interview transcripts and field-notes followed by inductive thematic analysis36. The analysis will identify a range of respondents’ views including local (micro level), regional (meso level) and national (macro level) participants. Methodological rigour will be ensured through standard procedures of reflexivity37. Regular analysis meetings will be held within and between the teams in Cardiff University and University of Plymouth. Cronbach α testing will be conducted on all four NPT components, to measure the internal consistency of the constructs within the context of this study. Each NPT component will be derived as the mean score of the four questions in the survey that correspond to that NPT component. Components will then be summarised and examined for potential associations by various roles or organisational characteristics. Descriptive statistics and bar charts will help visualise the ‘shape’ of the data within and eventually across case sites. These steps will help identify interesting or anomalous features within the data and prove useful in then generating cross-tabulations and scattergrams of the relationships between implementation factors and other variables. Survey analysis will be undertaken via SPSS. Convergent analysis32, via integration of the quantitative (survey) and qualitative datasets, will establish patterns of within-case similarities and differences regarding MCoC implementation. A comparative, cross-case synthesis will then follow in work package 3 (see below), though we have also scheduled a period into the work package 2 timeline to explicitly plan and prepare for our transition from within-case to cross-case analysis. Work Package 3: Cross-case analysis and synthesis of findings Work package 3 addresses objective 4. This objective will be achieved by comparing and contrasting factors influential to each case study’s approach to the development, organisation, and implementation of the MCoC model of care. The process of cross-case analysis and synthesis will follow a matrix approach38, consisting of a ‘tabular format that collects and arranges data for easy viewing in one place and permits cross-case analysis’. Specifically, to integrate findings across cases an inductive ‘data condensation’ process, foreshadowed by the overall research question and objectives, will initially be used to select, focus and simplify relevant findings from each site. Extracted findings will populate a series of cross-case thematic tables informed by NPT and CFIR frameworks, in order to map and understand the range of views and experiences across sites. Local implementation decisions will also be considered alongside the findings of the national and regional stakeholder interviews and the findings of the work package 1 narrative synthesis of MCoC implementation. Table 1 presents an overview of protocol and study related information. Table 2 displays the protocol amendments to date. | Data category | Information | |---|---| | Primary registry and trial identifying number | ISRCTN10635039 | | Date of registration in primary registry | 18th March 2024 | | Source(s) of monetary or material support | NIHR Health and Social Care Delivery Research | | Primary sponsor | University of Plymouth | | Contact for public queries | [email protected] | | Contact for scientific queries | [email protected] / [email protected] | | Public title | Factors influencing the implementation of the Midwifery Continuity of Care (MCoC) model of care in England: A mixed methods cross case analysis | | Countries of recruitment | England | | Health condition(s) or problem(s) studied | Implementation of the Midwifery Continuity of Care (MCoC) | | Intervention(s) | N/A | | Key inclusion and exclusion criteria | Inclusion criteria: - Individuals who directly affect, or are affected by, MCoC implementation. - Are associated with a case site. Exclusion criteria: - No groups are to be excluded from participating, unless there are clinical grounds barring participation following discussion with the midwifery team. | | Study type | A mixed methods cross case analysis | | Date of first enrolment | 19/07/2023 | | Target sample size | 90 (semi-structured interviews) | | Recruitment status | Open | | Primary outcome(s) | The main outcomes of the study will be to identify various local, regional and national approaches to MCoC implementation and key implementation factors and relationships and any discernible patterns between implementation factors and routinely reported MCoC outcomes. Through better understanding of local, regional and national factors contributing to varying progress with MCoC implementation, the findings of the study can be used to inform ongoing implementation of MCoC in England, and elsewhere and contribute to debates about future changes to maternity services. | Throughout this study we will follow the principles of good practice set out in the UK Policy Framework for Health and Social Care Research (Health Research Authority et al., 2021). Ethical issues in this project arise in work package 2: Comparative Case Studies and National and Regional Stakeholder Interviews. The primary ethical and research governance issues here are consent, anonymity, confidentiality, data protection and the safety of participants and researchers. Regarding consent, we will follow standard ethical procedures for gaining written informed consent from participants prior to them participating in the interview and subsequent them reading and considering the participant information sheets. In relation to data protection, all data we collect will be confidential to the project and stored securely in line with current University and NHS research governance and general data protection regulations. Any identifiable data will be anonymised prior to analysis in line with good research practice. In the context of participant safety and wellbeing, researchers will be trained in good interview practice as well as the use of distress protocols (including immediately ceasing the interview if participants become upset and providing avenues for support) and a disclosure protocol. All researchers accessing participants will be Disclosure and Barring Service (DBS) checked. Regarding researcher safety, we will follow the relevant University’s lone working policy. This study protocol has been approved by NHS, East Midlands – Nottingham 2 Research Ethics Committee and Health Research Authority, REC reference 23/EM/0272, approval date 14th December 2023. The national and regional stakeholder interviews were approved by University of Plymouth Faculty Research Ethics and Integrity Committee, approval date was 24th March 2023. Dissemination will occur throughout the project. Insights will contribute to current and future implementation of complex initiatives within maternity and other NHS services. Dissemination outputs will include clear, actionable, lessons to advance implementation decision making of national, regional, and local policy makers and practitioners. Findings will also be disseminated via international peer reviewed journals and conferences. PPI is embedded into each work package and a range of public engagement and dissemination events are planned throughout the project’s duration. The report will follow the NIHR threaded publication format. Project report and papers will be produced detailing findings and recommendations, training materials to be developed for use in other maternity services and in other NHS services. Results will be of interest to clinicians, practitioners and policy makers in the UK. No data are associated with this article. Figshare: SIMCA Study Material, Doi: https://doi.org/10.6084/m9.figshare.27831345.v139 This project contains the following extended data: 20230317SIMCAStakeholdersConsentFormONLINEv2_0.pdf SIMCA CASE SITE INTERVIEW GUIDE Board level.docx SIMCA CASE SITE INTERVIEW GUIDE Midwifery management.docx SIMCA CASE SITE INTERVIEW GUIDE Midwives.docx SIMCA CASE SITE INTERVIEW GUIDE Women and other service users.docx SIMCA Consent Form - Service Providers - v1.2 240124.docx SIMCA Consent Form - Service Users - v1.3 17042024.pdf SIMCA Participant information sheet - Service Providers - v2.1 240124.pdf SIMCA Participant information sheet - Service Users - v3.0 17042024.pdf SIMCA PIS - Stakeholders v3.0 17032023.docx SIMCA Poster - Service Providers - v1.1 240124.pdf SIMCA Poster - Service Users - v3.0 170424.pptx SIMCA STAKEHOLDER INTERVIEW GUIDE - National regional midwives.docx SIMCA STAKEHOLDER INTERVIEW GUIDE – NHSE.docx SIMCA STAKEHOLDER INTERVIEW GUIDE - Service user orgs and reps.docx Data is available under the terms of the CC BY 4.0 Figshare: SPIRIT reporting guidelines40,41 “The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of Care in England: A mixed methods cross case analysis.” Doi: https://doi.org/10.6084/m9.figshare.27831891.v1. Data is available under the terms of the CC BY 4.0 RM, AJ, SC, JS and SK have contributed to conceptualisation, funding acquisition, methodology, writing (original draft preparation and review and editing). AM and HS have contributed to methodology, writing (original draft preparation and review and editing) and SB, TP, LC and KD have contributed to funding acquisition, writing (original draft preparation and review and editing). All authors have reviewed the final draft. Our thanks to the Michaela Ayers and colleagues at the NIHR Clinical Research Network South West Peninsula and Jeannine Levers, Research Governance Officer, at the University of Plymouth for their study set-up and ongoing support. We would also like to acknowledge the contributions of Lorraine Craig, who has supported the administration of this research study. Their contributions to the day-to-day delivery of the study are invaluable and we thank them for their contribution. We thank the members of the PAG for their continued contributions and support. Faculty Opinions recommendedReferences - 1. World Health Organization: Recommendations on maternal health. 2017. Reference Source - 2. NHS: The long term plan. 2019. Reference Source - 3. Liberati EG, Tarrant C, Willars J, et al.: Seven features of safety in maternity units: a framework based on multisite ethnography and stakeholder consultation. BMJ Qual Saf. 2021; 30(6): 444–456. PubMed Abstract | Publisher Full Text | Free Full Text - 4. Andreasen S, Backe B, Jørstad RG, et al.: A nationwide descriptive study of obstetric claims for compensation in Norway. Acta Obstet Gynecol Scand. 2012; 91(10): 1191–5. PubMed Abstract | Publisher Full Text - 5. 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PubMed Abstract | Publisher Full Text | Free Full Text Author details Author details 1 Cardiff University Centre for Trials Research, Cardiff, Wales, UK 2 Cardiff University School of Healthcare Sciences, Cardiff, Wales, UK 3 School of Health Sciences, University of Birmingham, Birmingham, England, UK 4 University of Plymouth School of Nursing and Midwifery, Plymouth, England, UK 5 Tommy's Baby Charity, London, UK 6 The Mosaic Community Trust, London, UK 7 Imperial College Healthcare NHS Trust Division of Women's Children's and Clinical Support, London, England, UK 8 Imperial College London Women's Health Research, London, UK 2 Cardiff University School of Healthcare Sciences, Cardiff, Wales, UK 3 School of Health Sciences, University of Birmingham, Birmingham, England, UK 4 University of Plymouth School of Nursing and Midwifery, Plymouth, England, UK 5 Tommy's Baby Charity, London, UK 6 The Mosaic Community Trust, London, UK 7 Imperial College Healthcare NHS Trust Division of Women's Children's and Clinical Support, London, England, UK 8 Imperial College London Women's Health Research, London, UK Rebecca Milton Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Susan Channon Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Julia Sanders Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Sara Kenyon Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Aimee Middlemiss Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Heather Strange Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Kate Davies Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Lena Choudary-Salter Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Susan Barry Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Tina Prendeville Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Funding Acquisition, Writing – Original Draft Preparation, Writing – Review & Editing Aled Jones Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This project is funded by the National Institute for Health and Care Research (NIHR) under its Health and Social Care Delivery Research (HSDR) programme (Grant Reference Number: NIHR151802). SK is part funded by the Applied Research Collaboration (ARC) West Midlands (NIHR200165). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (2) Copyright © 2025 Milton R et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Milton R, Channon S, Sanders J et al. The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.13745.2) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions Version 2 VERSION 2 PUBLISHED 24 Apr 2025 Revised Views 0 How to cite this report: Vasilevski V. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.15167.r35349) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35349 https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35349 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 29 Apr 2025 Approved VIEWS 0 Thank you for giving me the opportunity to review this paper. You ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close Thank you for giving me the opportunity to review this paper. You have addressed the queries appropriately. I wish you the best with your study. Competing Interests: No competing interests were disclosed. Reviewer Expertise: Maternity service research CITE HOW TO CITE THIS REPORT Vasilevski V. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.15167.r35349) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35349 https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35349 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Views 0 How to cite this report: Sandall J. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.15167.r35351) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35351 https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35351 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 25 Apr 2025 Approved VIEWS 0 No ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close No further comments Competing Interests: No competing interests were disclosed. Reviewer Expertise: maternity service delivery CITE HOW TO CITE THIS REPORT Sandall J. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.15167.r35351) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35351 https://openresearch.nihr.ac.uk/articles/5-4/v2#referee-response-35351 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Version 1 VERSION 1 PUBLISHED 16 Jan 2025 Views 0 How to cite this report: Sandall J. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.14929.r34586) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34586 https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34586 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 10 Mar 2025 Approved VIEWS 0 Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim in the protocol is ‘To identify the local, regional and national factors ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim in the protocol is ‘To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England?’ In the study materials I see two aims and these need to be aligned. “to explore the factors influencing the implementation of MCoC in England, and to examine differences in how MCoC implementation has been operationalised, sustained, and experienced”. The design and methods are informed by implementation science frameworks in three work packages. The rational for the choice of the two frameworks guiding the Normalisation Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR) could be explained more. A literature review that has been published. Six case studies in NHS Trusts looking at MCoC implementation. I am not sure that data analysis is a separate work package or integral to WP2. Case study site selection in WP2 is described but has not included criteria to ensure some sites have had experience of settling down implementation. All organisational change has teething problems and needs time to embed, it is hoped that some sites will fulfill the criteria. It is also important to interview those who have had experience of implementation. This is not clear as for example in SIMCA Board level interview guide, one question asks ‘do you believe it improves care’. Rather than asking what an individual hypothesizes, it would be more helpful to ask them of any evidence or experience they have of intended or unintended impacts on women and staff or system. Belief also implies an ideology, rather than a factual question regarding impact on care (good or bad). Staff surveys are notorious for poor response rates. It is hoped this is about real word experiences rather than what staff have heard from colleagues either in their own trust or elsewhere. Pre-organisational change, there is always staff anxiety, far better to hear from their actual experiences. Similarly, it is important to interview some women who have experienced MCOC. How will predicted survey response be improved, and how will women whose voices are not heard be engaged. This is an experienced team and the findings grounded in an implementation science framework should provide useful and relevant information for decision makers. The design and methods are informed by implementation science frameworks in three work packages. The rational for the choice of the two frameworks guiding the Normalisation Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR) could be explained more. A literature review that has been published. Six case studies in NHS Trusts looking at MCoC implementation. I am not sure that data analysis is a separate work package or integral to WP2. Case study site selection in WP2 is described but has not included criteria to ensure some sites have had experience of settling down implementation. All organisational change has teething problems and needs time to embed, it is hoped that some sites will fulfill the criteria. It is also important to interview those who have had experience of implementation. This is not clear as for example in SIMCA Board level interview guide, one question asks ‘do you believe it improves care’. Rather than asking what an individual hypothesizes, it would be more helpful to ask them of any evidence or experience they have of intended or unintended impacts on women and staff or system. Belief also implies an ideology, rather than a factual question regarding impact on care (good or bad). Staff surveys are notorious for poor response rates. It is hoped this is about real word experiences rather than what staff have heard from colleagues either in their own trust or elsewhere. Pre-organisational change, there is always staff anxiety, far better to hear from their actual experiences. Similarly, it is important to interview some women who have experienced MCOC. How will predicted survey response be improved, and how will women whose voices are not heard be engaged. This is an experienced team and the findings grounded in an implementation science framework should provide useful and relevant information for decision makers. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: maternity service delivery CITE HOW TO CITE THIS REPORT Sandall J. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.14929.r34586) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34586 https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34586 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 24 Apr 2025Rebecca Milton, Cardiff University Centre for Trials Research, Cardiff, UK24 Apr 2025Author ResponseReviewer comment: Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim ... Continue reading Reviewer comment: Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim in the protocol is ‘To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England?’ In the study materials I see two aims and these need to be aligned. “to explore the factors influencing the implementation of MCoC in England, and to examine differences in how MCoC implementation has been operationalised, sustained, and experienced”. Author reaponse: Thank you for your comments. At this point the data collection is complete, and all documentation was approved by an ethics committee. Unfortunately, due to the timelines of the study this cannot be changed. Reviewer comment: The design and methods are informed by implementation science frameworks in three work packages. The rational for the choice of the two frameworks guiding the Normalisation Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR) could be explained more. Author response: The Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT) are well-suited for studying the implementation of complex, large-scale healthcare interventions such as MCoC due to their comprehensive and process-oriented approaches. CFIR provides a structured, multi-level framework to explore the key determinants of implementation, considering intervention characteristics, inner and outer settings, individuals involved, and implementation processes. This makes it particularly valuable for evaluating large-scale healthcare interventions that involve multiple stakeholders and organizational layers. NPT focuses on how interventions become embedded in routine practice by analysing the social and cognitive work required for implementation. It is especially useful for understanding the dynamic processes of adoption, integration, and sustainability, making it ideal for interventions that require behavioural and cultural change within healthcare settings. Together, these frameworks offer a complementary approach: CFIR helps identify barriers and facilitators to implementation at different levels, while NPT explains how and why an intervention is successfully normalised into routine practice. This combination is particularly powerful for addressing the complexities of real-world healthcare implementation beyond what other models may capture. Reviewer comment: A literature review that has been published. Author response: Thank you, this has since been referenced. Reviewer comment: Six case studies in NHS Trusts looking at MCoC implementation. I am not sure that data analysis is a separate work package or integral to WP2. Author response: Case study site selection in WP2 is described but has not included criteria to ensure some sites have had experience of settling down implementation. All organisational change has teething problems and needs time to embed, it is hoped that some sites will fulfill the criteria. Thank you for your comment, work package 3 is a separate work package, it is a cross-case analysis and synthesis of findings of WP1 & 2. Reviewer comment: It is also important to interview those who have had experience of implementation. This is not clear as for example in SIMCA Board level interview guide, one question asks ‘do you believe it improves care’. Rather than asking what an individual hypothesizes, it would be more helpful to ask them of any evidence or experience they have of intended or unintended impacts on women and staff or system. Belief also implies an ideology, rather than a factual question regarding impact on care (good or bad). Author response: Thank you for your comment, we interviewed staff and women with a range of experiences of implementation of MCoC. We take on board your feedback for future research. Reviewer comment: Staff surveys are notorious for poor response rates. It is hoped this is about real word experiences rather than what staff have heard from colleagues either in their own trust or elsewhere. Pre-organisational change, there is always staff anxiety, far better to hear from their actual experiences. Similarly, it is important to interview some women who have experienced MCOC. How will predicted survey response be improved, and how will women whose voices are not heard be engaged. Author response: Thank you for your comment, NoMAd which is about real-world experiences: It is designed for measuring implementation processes from the perspective of professionals directly involved in the work of implementing complex interventions in healthcare.Reviewer comment: Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim in the protocol is ‘To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England?’ In the study materials I see two aims and these need to be aligned. “to explore the factors influencing the implementation of MCoC in England, and to examine differences in how MCoC implementation has been operationalised, sustained, and experienced”.Competing Interests: No competing interests were disclosed. Close Author reaponse: Thank you for your comments. At this point the data collection is complete, and all documentation was approved by an ethics committee. Unfortunately, due to the timelines of the study this cannot be changed. Reviewer comment: The design and methods are informed by implementation science frameworks in three work packages. The rational for the choice of the two frameworks guiding the Normalisation Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR) could be explained more. Author response: The Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT) are well-suited for studying the implementation of complex, large-scale healthcare interventions such as MCoC due to their comprehensive and process-oriented approaches. CFIR provides a structured, multi-level framework to explore the key determinants of implementation, considering intervention characteristics, inner and outer settings, individuals involved, and implementation processes. This makes it particularly valuable for evaluating large-scale healthcare interventions that involve multiple stakeholders and organizational layers. NPT focuses on how interventions become embedded in routine practice by analysing the social and cognitive work required for implementation. It is especially useful for understanding the dynamic processes of adoption, integration, and sustainability, making it ideal for interventions that require behavioural and cultural change within healthcare settings. Together, these frameworks offer a complementary approach: CFIR helps identify barriers and facilitators to implementation at different levels, while NPT explains how and why an intervention is successfully normalised into routine practice. This combination is particularly powerful for addressing the complexities of real-world healthcare implementation beyond what other models may capture. Reviewer comment: A literature review that has been published. Author response: Thank you, this has since been referenced. Reviewer comment: Six case studies in NHS Trusts looking at MCoC implementation. I am not sure that data analysis is a separate work package or integral to WP2. Author response: Case study site selection in WP2 is described but has not included criteria to ensure some sites have had experience of settling down implementation. All organisational change has teething problems and needs time to embed, it is hoped that some sites will fulfill the criteria. Thank you for your comment, work package 3 is a separate work package, it is a cross-case analysis and synthesis of findings of WP1 & 2. Reviewer comment: It is also important to interview those who have had experience of implementation. This is not clear as for example in SIMCA Board level interview guide, one question asks ‘do you believe it improves care’. Rather than asking what an individual hypothesizes, it would be more helpful to ask them of any evidence or experience they have of intended or unintended impacts on women and staff or system. Belief also implies an ideology, rather than a factual question regarding impact on care (good or bad). Author response: Thank you for your comment, we interviewed staff and women with a range of experiences of implementation of MCoC. We take on board your feedback for future research. Reviewer comment: Staff surveys are notorious for poor response rates. It is hoped this is about real word experiences rather than what staff have heard from colleagues either in their own trust or elsewhere. Pre-organisational change, there is always staff anxiety, far better to hear from their actual experiences. Similarly, it is important to interview some women who have experienced MCOC. How will predicted survey response be improved, and how will women whose voices are not heard be engaged. Author response: Thank you for your comment, NoMAd which is about real-world experiences: It is designed for measuring implementation processes from the perspective of professionals directly involved in the work of implementing complex interventions in healthcare. COMMENTS ON THIS REPORT - Author Response 24 Apr 2025Rebecca Milton, Cardiff University Centre for Trials Research, Cardiff, UK24 Apr 2025Author ResponseReviewer comment: Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim ... Continue reading Reviewer comment: Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim in the protocol is ‘To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England?’ In the study materials I see two aims and these need to be aligned. “to explore the factors influencing the implementation of MCoC in England, and to examine differences in how MCoC implementation has been operationalised, sustained, and experienced”. Author reaponse: Thank you for your comments. At this point the data collection is complete, and all documentation was approved by an ethics committee. Unfortunately, due to the timelines of the study this cannot be changed. Reviewer comment: The design and methods are informed by implementation science frameworks in three work packages. The rational for the choice of the two frameworks guiding the Normalisation Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR) could be explained more. Author response: The Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT) are well-suited for studying the implementation of complex, large-scale healthcare interventions such as MCoC due to their comprehensive and process-oriented approaches. CFIR provides a structured, multi-level framework to explore the key determinants of implementation, considering intervention characteristics, inner and outer settings, individuals involved, and implementation processes. This makes it particularly valuable for evaluating large-scale healthcare interventions that involve multiple stakeholders and organizational layers. NPT focuses on how interventions become embedded in routine practice by analysing the social and cognitive work required for implementation. It is especially useful for understanding the dynamic processes of adoption, integration, and sustainability, making it ideal for interventions that require behavioural and cultural change within healthcare settings. Together, these frameworks offer a complementary approach: CFIR helps identify barriers and facilitators to implementation at different levels, while NPT explains how and why an intervention is successfully normalised into routine practice. This combination is particularly powerful for addressing the complexities of real-world healthcare implementation beyond what other models may capture. Reviewer comment: A literature review that has been published. Author response: Thank you, this has since been referenced. Reviewer comment: Six case studies in NHS Trusts looking at MCoC implementation. I am not sure that data analysis is a separate work package or integral to WP2. Author response: Case study site selection in WP2 is described but has not included criteria to ensure some sites have had experience of settling down implementation. All organisational change has teething problems and needs time to embed, it is hoped that some sites will fulfill the criteria. Thank you for your comment, work package 3 is a separate work package, it is a cross-case analysis and synthesis of findings of WP1 & 2. Reviewer comment: It is also important to interview those who have had experience of implementation. This is not clear as for example in SIMCA Board level interview guide, one question asks ‘do you believe it improves care’. Rather than asking what an individual hypothesizes, it would be more helpful to ask them of any evidence or experience they have of intended or unintended impacts on women and staff or system. Belief also implies an ideology, rather than a factual question regarding impact on care (good or bad). Author response: Thank you for your comment, we interviewed staff and women with a range of experiences of implementation of MCoC. We take on board your feedback for future research. Reviewer comment: Staff surveys are notorious for poor response rates. It is hoped this is about real word experiences rather than what staff have heard from colleagues either in their own trust or elsewhere. Pre-organisational change, there is always staff anxiety, far better to hear from their actual experiences. Similarly, it is important to interview some women who have experienced MCOC. How will predicted survey response be improved, and how will women whose voices are not heard be engaged. Author response: Thank you for your comment, NoMAd which is about real-world experiences: It is designed for measuring implementation processes from the perspective of professionals directly involved in the work of implementing complex interventions in healthcare.Reviewer comment: Its important to have the overall aim consistently described in study materials. For example, The aim of the research is described differently in different study materials. The aim in the protocol is ‘To identify the local, regional and national factors which contribute to variable progress with implementation of MCoC in the NHS in England?’ In the study materials I see two aims and these need to be aligned. “to explore the factors influencing the implementation of MCoC in England, and to examine differences in how MCoC implementation has been operationalised, sustained, and experienced”.Competing Interests: No competing interests were disclosed. Close Author reaponse: Thank you for your comments. At this point the data collection is complete, and all documentation was approved by an ethics committee. Unfortunately, due to the timelines of the study this cannot be changed. Reviewer comment: The design and methods are informed by implementation science frameworks in three work packages. The rational for the choice of the two frameworks guiding the Normalisation Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR) could be explained more. Author response: The Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT) are well-suited for studying the implementation of complex, large-scale healthcare interventions such as MCoC due to their comprehensive and process-oriented approaches. CFIR provides a structured, multi-level framework to explore the key determinants of implementation, considering intervention characteristics, inner and outer settings, individuals involved, and implementation processes. This makes it particularly valuable for evaluating large-scale healthcare interventions that involve multiple stakeholders and organizational layers. NPT focuses on how interventions become embedded in routine practice by analysing the social and cognitive work required for implementation. It is especially useful for understanding the dynamic processes of adoption, integration, and sustainability, making it ideal for interventions that require behavioural and cultural change within healthcare settings. Together, these frameworks offer a complementary approach: CFIR helps identify barriers and facilitators to implementation at different levels, while NPT explains how and why an intervention is successfully normalised into routine practice. This combination is particularly powerful for addressing the complexities of real-world healthcare implementation beyond what other models may capture. Reviewer comment: A literature review that has been published. Author response: Thank you, this has since been referenced. Reviewer comment: Six case studies in NHS Trusts looking at MCoC implementation. I am not sure that data analysis is a separate work package or integral to WP2. Author response: Case study site selection in WP2 is described but has not included criteria to ensure some sites have had experience of settling down implementation. All organisational change has teething problems and needs time to embed, it is hoped that some sites will fulfill the criteria. Thank you for your comment, work package 3 is a separate work package, it is a cross-case analysis and synthesis of findings of WP1 & 2. Reviewer comment: It is also important to interview those who have had experience of implementation. This is not clear as for example in SIMCA Board level interview guide, one question asks ‘do you believe it improves care’. Rather than asking what an individual hypothesizes, it would be more helpful to ask them of any evidence or experience they have of intended or unintended impacts on women and staff or system. Belief also implies an ideology, rather than a factual question regarding impact on care (good or bad). Author response: Thank you for your comment, we interviewed staff and women with a range of experiences of implementation of MCoC. We take on board your feedback for future research. Reviewer comment: Staff surveys are notorious for poor response rates. It is hoped this is about real word experiences rather than what staff have heard from colleagues either in their own trust or elsewhere. Pre-organisational change, there is always staff anxiety, far better to hear from their actual experiences. Similarly, it is important to interview some women who have experienced MCOC. How will predicted survey response be improved, and how will women whose voices are not heard be engaged. Author response: Thank you for your comment, NoMAd which is about real-world experiences: It is designed for measuring implementation processes from the perspective of professionals directly involved in the work of implementing complex interventions in healthcare. Views 0 How to cite this report: Sweet L. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.14929.r34582) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34582 https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34582 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 21 Feb 2025 Approved VIEWS 0 Thank you for the opportunity to review this study protocol. It is a timely and much-needed study. The team is strong, and the work packages are achievable. There are a few acronyms used before being qualified and some minor ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close There are a few acronyms used before being qualified and some minor ... Continue reading Thank you for the opportunity to review this study protocol. It is a timely and much-needed study. The team is strong, and the work packages are achievable. There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .." In WP2, the first sentence for study participants is confusing at first read and is one very long sentence. I look forward to following the outcome of this work. There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .." In WP2, the first sentence for study participants is confusing at first read and is one very long sentence. I look forward to following the outcome of this work. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Midwifery CITE HOW TO CITE THIS REPORT Sweet L. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.14929.r34582) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34582 https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34582 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 24 Apr 2025Rebecca Milton, Cardiff University Centre for Trials Research, Cardiff, UK24 Apr 2025Author ResponseReviewer comment: There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .." Author response: Thank you for your comment about ... Continue reading Reviewer comment: There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .." Author response: Thank you for your comment about the acronyms, this has been amended. Regarding your comment about use of anthropomorphic statements I have edited this specific example to the following: The aim of the study is to… and similarly “the study aims…” has been changed to “the aim of the study” Reviewer comment: In WP2, the first sentence for study participants is confusing at first read and is one very long sentence. I look forward to following the outcome of this work. Author response: Thank you this has been restructured.Reviewer comment: There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .."Competing Interests: No competing interests were disclosed. Close Author response: Thank you for your comment about the acronyms, this has been amended. Regarding your comment about use of anthropomorphic statements I have edited this specific example to the following: The aim of the study is to… and similarly “the study aims…” has been changed to “the aim of the study” Reviewer comment: In WP2, the first sentence for study participants is confusing at first read and is one very long sentence. I look forward to following the outcome of this work. Author response: Thank you this has been restructured. COMMENTS ON THIS REPORT - Author Response 24 Apr 2025Rebecca Milton, Cardiff University Centre for Trials Research, Cardiff, UK24 Apr 2025Author ResponseReviewer comment: There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .." Author response: Thank you for your comment about ... Continue reading Reviewer comment: There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .." Author response: Thank you for your comment about the acronyms, this has been amended. Regarding your comment about use of anthropomorphic statements I have edited this specific example to the following: The aim of the study is to… and similarly “the study aims…” has been changed to “the aim of the study” Reviewer comment: In WP2, the first sentence for study participants is confusing at first read and is one very long sentence. I look forward to following the outcome of this work. Author response: Thank you this has been restructured.Reviewer comment: There are a few acronyms used before being qualified and some minor anthropomorphic statements such as 'This study proposes .."Competing Interests: No competing interests were disclosed. Close Author response: Thank you for your comment about the acronyms, this has been amended. Regarding your comment about use of anthropomorphic statements I have edited this specific example to the following: The aim of the study is to… and similarly “the study aims…” has been changed to “the aim of the study” Reviewer comment: In WP2, the first sentence for study participants is confusing at first read and is one very long sentence. I look forward to following the outcome of this work. Author response: Thank you this has been restructured. Views 0 How to cite this report: Vasilevski V. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.14929.r34730) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34730 https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34730 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 17 Feb 2025 Approved with Reservations VIEWS 0 Thanks for inviting me to review this paper. It is well established that MCoC improves a range of outcomes for women, babies, and the healthcare system, however, successful implementation remains a significant challenge. Understanding MCoC implementation, and the various factors ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close Thanks for inviting me to review this paper. It is well established that MCoC improves a range of outcomes for women, babies, and the healthcare system, however, successful implementation remains a significant challenge. Understanding MCoC implementation, and the various factors that influence it, will contribute knowledge that can support broader implementation of MCoC internationally. Overall, this is a very clear and well written protocol, however a bit more detail is required in the methods. Please see my queries related to specific sections of the paper below:

Nice summary of the overall study

Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with an acronym, but with the full term. Theoretical/conceptual framework: The following sentence 'CFIR is not intended to be applied wholesale...' I don't think 'wholesale' is the right term here. WP2: Study setting: Could more details about the NHS settings in England be provided, are they from areas with similar demographics or are they diverse? Study participants: '15 interviews per site (n=10)' The (n=10) placements appears as if you are including 10 sites, possibly move it after managers, midwives etc., and then (n=5) after women enrolled in MCoC. How many participants are you aiming for the surveys? Consider sample size calculation if appropriate. Data collection and management: What is 'Speak Up Guardians' please define for the non-UK audience. Please describe the tools you are using in more detail, are they validated tools or tools designed specifically for this project? You state that components will be summarised and examined for potential associations, what outcomes will you be looking for specifically? Recorded semi-structured interviews in six case study sites: n=90? Stated above n=65, please clarify. The detail here is also repetitive of the above, decide where it fits better. Data analysis: There is no mention of what statistical tests are anticipated to be used for the survey component. Overall: There are many acronyms used throughout, which impact the flow of reading when they are not familiar, consider minimising the number of acronyms used.

Nice summary of the overall study

Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with an acronym, but with the full term. Theoretical/conceptual framework: The following sentence 'CFIR is not intended to be applied wholesale...' I don't think 'wholesale' is the right term here. WP2: Study setting: Could more details about the NHS settings in England be provided, are they from areas with similar demographics or are they diverse? Study participants: '15 interviews per site (n=10)' The (n=10) placements appears as if you are including 10 sites, possibly move it after managers, midwives etc., and then (n=5) after women enrolled in MCoC. How many participants are you aiming for the surveys? Consider sample size calculation if appropriate. Data collection and management: What is 'Speak Up Guardians' please define for the non-UK audience. Please describe the tools you are using in more detail, are they validated tools or tools designed specifically for this project? You state that components will be summarised and examined for potential associations, what outcomes will you be looking for specifically? Recorded semi-structured interviews in six case study sites: n=90? Stated above n=65, please clarify. The detail here is also repetitive of the above, decide where it fits better. Data analysis: There is no mention of what statistical tests are anticipated to be used for the survey component. Overall: There are many acronyms used throughout, which impact the flow of reading when they are not familiar, consider minimising the number of acronyms used. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Partly - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Maternity service research CITE HOW TO CITE THIS REPORT Vasilevski V. Reviewer Report For: The SIMCA Study Protocol: Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in NHS maternity care in England: A mixed methods cross case analysis involving clinicians, women and policy makers [version 2; peer review: 3 approved]. NIHR Open Res 2025, 5:4 (https://doi.org/10.3310/nihropenres.14929.r34730) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34730 https://openresearch.nihr.ac.uk/articles/5-4/v1#referee-response-34730 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 24 Apr 2025Rebecca Milton, Cardiff University Centre for Trials Research, Cardiff, UK24 Apr 2025Author ResponseReviewer comment: Abstract: Nice summary of the overall study. Introduction: Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with ... Continue reading Reviewer comment: Abstract: Nice summary of the overall study. Introduction: Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with an acronym, but with the full term. Author response: Thank you for your comment, I can confirm that this has been amended. NHS has been replaced with National Health Service (NHS). Reviewer comment: Theoretical/conceptual framework: The following sentence 'CFIR is not intended to be applied wholesale...' I don't think 'wholesale' is the right term here. Author response: Thank you for your comment, the wording has been amended to: CFIR offers numerous constructs to consider when investigating implementation of complex interventions and will be applied accordingly. Reviewer comment: WP2: Study setting: Could more details about the NHS settings in England be provided, are they from areas with similar demographics or are they diverse? Author response: Thank you for your query, the study sites are to remain anonymous. However, I feel that this point is addressed in: ‘Sampling and selecting case studies’. For example, we have described how geographical and organisational diversity will be considered during site sampling. We have also acknowledged the consideration of different demographics in the rewording as follows "Consideration of geographical settings of case study sites to ensure that case studies reflect, where possible, demographic and regional differences in rural, urban, and inner-city areas of England." Reviewer comment: Study participants: '15 interviews per site (n=10)' The (n=10) placements appears as if you are including 10 sites, possibly move it after managers, midwives etc., and then (n=5) after women enrolled in MCoC. How many participants are you aiming for the surveys? Consider sample size calculation if appropriate. Author response: Thank you for your comment, I agree with your point about the way this sentence is structured: 15 interviews per site (n=10) purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians and (n=5) women enrolled in MCoC. This has been altered to 15 interviews per site, consisting of purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians (n=10) and women enrolled in MCoC (n=5). Regarding the anonymous survey we did not have a target number for completion, this wasn’t something we could monitor. We have retrospective numbers now. In study set up it was advised that the survey responses were not included in the site sample sizes. Reviewer comment: Data collection and management: What is 'Speak Up Guardians' please define for the non-UK audience. Author response: Thank you for your comment, this has been changed to Staff Speak Up. The aim of this intervention is to help the NHS deliver the People Promise for workers; by ensuring they have a voice that counts and by developing a speaking up culture. Reviewer comment: Data collection and management: Please describe the tools you are using in more detail, are they validated tools or tools designed specifically for this project? Author response: Thank you for your comment, the text has been updated to: Staff survey: a validated staff survey tool (NOMAD)33 will be used to collect the perceptions and experiences of maternity staff about the implementation of MCoC in the maternity services within which they work. Reviewer comment: Data collection and management: You state that components will be summarised and examined for potential associations, what outcomes will you be looking for specifically? Author response: Thank you for your comment. To clarify, the data generated does not aim to analyse outcomes or associations between outcomes. The survey instruments measure implementation experience and perceptions, not outcomes, enabling possible inference between roles and organisational characteristics as described in the text Reviewer comment: Data collection and management: Recorded semi-structured interviews in six case study sites: n=90? Stated above n=65, please clarify. The detail here is also repetitive of the above, decide where it fits better. Author response: Thank you for your query, there are two sets of interviews being conducted. One is with national and regional leads (n=65) and the second is with study participants (n=90). This section has been restructured to improve readability. Reviewer comment: Data analysis: There is no mention of what statistical tests are anticipated to be used for the survey component. Author response: We state that ‘Cronbach α testing will be conducted on all four NPT components, to measure the internal consistency of the constructs within the context of this study. Each NPT component will be derived as the mean score of the four questions in the survey that correspond to that NPT component. Components will then be summarised and examined for potential associations by various roles or organisational characteristics. Descriptive statistics and bar charts will help visualise the ‘shape’ of the data within and eventually across case sites. These steps will help identify interesting or anomalous features within the data and prove useful in then generating cross-tabulations and scattergrams of the relationships between implementation factors and other variables. Survey analysis will be undertaken via SPSS.’ This has been moved to the analysis section. Reviewer comment: Overall: There are many acronyms used throughout, which impact the flow of reading when they are not familiar, consider minimising the number of acronyms used. Author response: Thank you, I have reviewed this and have removed the less frequently used acronyms throughout.Reviewer comment: Abstract: Nice summary of the overall study. Introduction: Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with an acronym, but with the full term.Competing Interests: No competing interests were disclosed. Close Author response: Thank you for your comment, I can confirm that this has been amended. NHS has been replaced with National Health Service (NHS). Reviewer comment: Theoretical/conceptual framework: The following sentence 'CFIR is not intended to be applied wholesale...' I don't think 'wholesale' is the right term here. Author response: Thank you for your comment, the wording has been amended to: CFIR offers numerous constructs to consider when investigating implementation of complex interventions and will be applied accordingly. Reviewer comment: WP2: Study setting: Could more details about the NHS settings in England be provided, are they from areas with similar demographics or are they diverse? Author response: Thank you for your query, the study sites are to remain anonymous. However, I feel that this point is addressed in: ‘Sampling and selecting case studies’. For example, we have described how geographical and organisational diversity will be considered during site sampling. We have also acknowledged the consideration of different demographics in the rewording as follows "Consideration of geographical settings of case study sites to ensure that case studies reflect, where possible, demographic and regional differences in rural, urban, and inner-city areas of England." Reviewer comment: Study participants: '15 interviews per site (n=10)' The (n=10) placements appears as if you are including 10 sites, possibly move it after managers, midwives etc., and then (n=5) after women enrolled in MCoC. How many participants are you aiming for the surveys? Consider sample size calculation if appropriate. Author response: Thank you for your comment, I agree with your point about the way this sentence is structured: 15 interviews per site (n=10) purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians and (n=5) women enrolled in MCoC. This has been altered to 15 interviews per site, consisting of purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians (n=10) and women enrolled in MCoC (n=5). Regarding the anonymous survey we did not have a target number for completion, this wasn’t something we could monitor. We have retrospective numbers now. In study set up it was advised that the survey responses were not included in the site sample sizes. Reviewer comment: Data collection and management: What is 'Speak Up Guardians' please define for the non-UK audience. Author response: Thank you for your comment, this has been changed to Staff Speak Up. The aim of this intervention is to help the NHS deliver the People Promise for workers; by ensuring they have a voice that counts and by developing a speaking up culture. Reviewer comment: Data collection and management: Please describe the tools you are using in more detail, are they validated tools or tools designed specifically for this project? Author response: Thank you for your comment, the text has been updated to: Staff survey: a validated staff survey tool (NOMAD)33 will be used to collect the perceptions and experiences of maternity staff about the implementation of MCoC in the maternity services within which they work. Reviewer comment: Data collection and management: You state that components will be summarised and examined for potential associations, what outcomes will you be looking for specifically? Author response: Thank you for your comment. To clarify, the data generated does not aim to analyse outcomes or associations between outcomes. The survey instruments measure implementation experience and perceptions, not outcomes, enabling possible inference between roles and organisational characteristics as described in the text Reviewer comment: Data collection and management: Recorded semi-structured interviews in six case study sites: n=90? Stated above n=65, please clarify. The detail here is also repetitive of the above, decide where it fits better. Author response: Thank you for your query, there are two sets of interviews being conducted. One is with national and regional leads (n=65) and the second is with study participants (n=90). This section has been restructured to improve readability. Reviewer comment: Data analysis: There is no mention of what statistical tests are anticipated to be used for the survey component. Author response: We state that ‘Cronbach α testing will be conducted on all four NPT components, to measure the internal consistency of the constructs within the context of this study. Each NPT component will be derived as the mean score of the four questions in the survey that correspond to that NPT component. Components will then be summarised and examined for potential associations by various roles or organisational characteristics. Descriptive statistics and bar charts will help visualise the ‘shape’ of the data within and eventually across case sites. These steps will help identify interesting or anomalous features within the data and prove useful in then generating cross-tabulations and scattergrams of the relationships between implementation factors and other variables. Survey analysis will be undertaken via SPSS.’ This has been moved to the analysis section. Reviewer comment: Overall: There are many acronyms used throughout, which impact the flow of reading when they are not familiar, consider minimising the number of acronyms used. Author response: Thank you, I have reviewed this and have removed the less frequently used acronyms throughout. COMMENTS ON THIS REPORT - Author Response 24 Apr 2025Rebecca Milton, Cardiff University Centre for Trials Research, Cardiff, UK24 Apr 2025Author ResponseReviewer comment: Abstract: Nice summary of the overall study. Introduction: Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with ... Continue reading Reviewer comment: Abstract: Nice summary of the overall study. Introduction: Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with an acronym, but with the full term. Author response: Thank you for your comment, I can confirm that this has been amended. NHS has been replaced with National Health Service (NHS). Reviewer comment: Theoretical/conceptual framework: The following sentence 'CFIR is not intended to be applied wholesale...' I don't think 'wholesale' is the right term here. Author response: Thank you for your comment, the wording has been amended to: CFIR offers numerous constructs to consider when investigating implementation of complex interventions and will be applied accordingly. Reviewer comment: WP2: Study setting: Could more details about the NHS settings in England be provided, are they from areas with similar demographics or are they diverse? Author response: Thank you for your query, the study sites are to remain anonymous. However, I feel that this point is addressed in: ‘Sampling and selecting case studies’. For example, we have described how geographical and organisational diversity will be considered during site sampling. We have also acknowledged the consideration of different demographics in the rewording as follows "Consideration of geographical settings of case study sites to ensure that case studies reflect, where possible, demographic and regional differences in rural, urban, and inner-city areas of England." Reviewer comment: Study participants: '15 interviews per site (n=10)' The (n=10) placements appears as if you are including 10 sites, possibly move it after managers, midwives etc., and then (n=5) after women enrolled in MCoC. How many participants are you aiming for the surveys? Consider sample size calculation if appropriate. Author response: Thank you for your comment, I agree with your point about the way this sentence is structured: 15 interviews per site (n=10) purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians and (n=5) women enrolled in MCoC. This has been altered to 15 interviews per site, consisting of purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians (n=10) and women enrolled in MCoC (n=5). Regarding the anonymous survey we did not have a target number for completion, this wasn’t something we could monitor. We have retrospective numbers now. In study set up it was advised that the survey responses were not included in the site sample sizes. Reviewer comment: Data collection and management: What is 'Speak Up Guardians' please define for the non-UK audience. Author response: Thank you for your comment, this has been changed to Staff Speak Up. The aim of this intervention is to help the NHS deliver the People Promise for workers; by ensuring they have a voice that counts and by developing a speaking up culture. Reviewer comment: Data collection and management: Please describe the tools you are using in more detail, are they validated tools or tools designed specifically for this project? Author response: Thank you for your comment, the text has been updated to: Staff survey: a validated staff survey tool (NOMAD)33 will be used to collect the perceptions and experiences of maternity staff about the implementation of MCoC in the maternity services within which they work. Reviewer comment: Data collection and management: You state that components will be summarised and examined for potential associations, what outcomes will you be looking for specifically? Author response: Thank you for your comment. To clarify, the data generated does not aim to analyse outcomes or associations between outcomes. The survey instruments measure implementation experience and perceptions, not outcomes, enabling possible inference between roles and organisational characteristics as described in the text Reviewer comment: Data collection and management: Recorded semi-structured interviews in six case study sites: n=90? Stated above n=65, please clarify. The detail here is also repetitive of the above, decide where it fits better. Author response: Thank you for your query, there are two sets of interviews being conducted. One is with national and regional leads (n=65) and the second is with study participants (n=90). This section has been restructured to improve readability. Reviewer comment: Data analysis: There is no mention of what statistical tests are anticipated to be used for the survey component. Author response: We state that ‘Cronbach α testing will be conducted on all four NPT components, to measure the internal consistency of the constructs within the context of this study. Each NPT component will be derived as the mean score of the four questions in the survey that correspond to that NPT component. Components will then be summarised and examined for potential associations by various roles or organisational characteristics. Descriptive statistics and bar charts will help visualise the ‘shape’ of the data within and eventually across case sites. These steps will help identify interesting or anomalous features within the data and prove useful in then generating cross-tabulations and scattergrams of the relationships between implementation factors and other variables. Survey analysis will be undertaken via SPSS.’ This has been moved to the analysis section. Reviewer comment: Overall: There are many acronyms used throughout, which impact the flow of reading when they are not familiar, consider minimising the number of acronyms used. Author response: Thank you, I have reviewed this and have removed the less frequently used acronyms throughout.Reviewer comment: Abstract: Nice summary of the overall study. Introduction: Great introduction, covering background and rationale to the study. A minor point, generally you would not start a sentence with an acronym, but with the full term.Competing Interests: No competing interests were disclosed. Close Author response: Thank you for your comment, I can confirm that this has been amended. NHS has been replaced with National Health Service (NHS). Reviewer comment: Theoretical/conceptual framework: The following sentence 'CFIR is not intended to be applied wholesale...' I don't think 'wholesale' is the right term here. Author response: Thank you for your comment, the wording has been amended to: CFIR offers numerous constructs to consider when investigating implementation of complex interventions and will be applied accordingly. Reviewer comment: WP2: Study setting: Could more details about the NHS settings in England be provided, are they from areas with similar demographics or are they diverse? Author response: Thank you for your query, the study sites are to remain anonymous. However, I feel that this point is addressed in: ‘Sampling and selecting case studies’. For example, we have described how geographical and organisational diversity will be considered during site sampling. We have also acknowledged the consideration of different demographics in the rewording as follows "Consideration of geographical settings of case study sites to ensure that case studies reflect, where possible, demographic and regional differences in rural, urban, and inner-city areas of England." Reviewer comment: Study participants: '15 interviews per site (n=10)' The (n=10) placements appears as if you are including 10 sites, possibly move it after managers, midwives etc., and then (n=5) after women enrolled in MCoC. How many participants are you aiming for the surveys? Consider sample size calculation if appropriate. Author response: Thank you for your comment, I agree with your point about the way this sentence is structured: 15 interviews per site (n=10) purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians and (n=5) women enrolled in MCoC. This has been altered to 15 interviews per site, consisting of purposively sampled participants including those directly involved in MCoC implementation, for example, managers, midwives, obstetricians (n=10) and women enrolled in MCoC (n=5). Regarding the anonymous survey we did not have a target number for completion, this wasn’t something we could monitor. We have retrospective numbers now. In study set up it was advised that the survey responses were not included in the site sample sizes. Reviewer comment: Data collection and management: What is 'Speak Up Guardians' please define for the non-UK audience. Author response: Thank you for your comment, this has been changed to Staff Speak Up. The aim of this intervention is to help the NHS deliver the People Promise for workers; by ensuring they have a voice that counts and by developing a speaking up culture. Reviewer comment: Data collection and management: Please describe the tools you are using in more detail, are they validated tools or tools designed specifically for this project? Author response: Thank you for your comment, the text has been updated to: Staff survey: a validated staff survey tool (NOMAD)33 will be used to collect the perceptions and experiences of maternity staff about the implementation of MCoC in the maternity services within which they work. Reviewer comment: Data collection and management: You state that components will be summarised and examined for potential associations, what outcomes will you be looking for specifically? Author response: Thank you for your comment. To clarify, the data generated does not aim to analyse outcomes or associations between outcomes. The survey instruments measure implementation experience and perceptions, not outcomes, enabling possible inference between roles and organisational characteristics as described in the text Reviewer comment: Data collection and management: Recorded semi-structured interviews in six case study sites: n=90? Stated above n=65, please clarify. The detail here is also repetitive of the above, decide where it fits better. Author response: Thank you for your query, there are two sets of interviews being conducted. One is with national and regional leads (n=65) and the second is with study participants (n=90). This section has been restructured to improve readability. Reviewer comment: Data analysis: There is no mention of what statistical tests are anticipated to be used for the survey component. Author response: We state that ‘Cronbach α testing will be conducted on all four NPT components, to measure the internal consistency of the constructs within the context of this study. Each NPT component will be derived as the mean score of the four questions in the survey that correspond to that NPT component. Components will then be summarised and examined for potential associations by various roles or organisational characteristics. Descriptive statistics and bar charts will help visualise the ‘shape’ of the data within and eventually across case sites. These steps will help identify interesting or anomalous features within the data and prove useful in then generating cross-tabulations and scattergrams of the relationships between implementation factors and other variables. Survey analysis will be undertaken via SPSS.’ This has been moved to the analysis section. Reviewer comment: Overall: There are many acronyms used throughout, which impact the flow of reading when they are not familiar, consider minimising the number of acronyms used. Author response: Thank you, I have reviewed this and have removed the less frequently used acronyms throughout. Alongside their report, reviewers assign a status to the article: - Approved - Approved with reservations - Not approved | Invited Reviewers | ||| |---|---|---|---| | 1 | 2 | 3 | | | Version 2 (revision) 24 Apr 25 | read | read | | | Version 1 16 Jan 25 | read | read | read | Sign up for content alerts You are now signed up to receive this alert Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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