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Background: Antenatal care (ANC) is a core component of maternity care. However, both quality of care provision and rates of attendance vary widely between and within countries. Qualitative research can assess factors underlying variation, including acceptability, feasibility, and the values and beliefs that frame provision and uptake of ANC programmes.This synthesis links to the Cochrane Reviews of the effectiveness of different antenatal models of care. It was designed to inform the World Health Organization guidelines for a positive pregnancy experience and to provide insights for the design and implementation of improved antenatal care in the future., Objectives: To identify, appraise, and synthesise qualitative studies exploring:· Women's views and experiences of attending ANC; and factors influencing the uptake of ANC arising from women's accounts;· Healthcare providers' views and experiences of providing ANC; and factors influencing the provision of ANC arising from the accounts of healthcare providers., Search Methods: To find primary studies we searched MEDLINE, Ovid; Embase, Ovid; CINAHL, EbscoHost; PsycINFO, EbscoHost; AMED, EbscoHost; LILACS, VHL; and African Journals Online (AJOL) from January 2000 to February 2019. We handsearched reference lists of included papers and checked the contents pages of 50 relevant journals through Zetoc alerts received during the searching phase., Selection Criteria: We included studies that used qualitative methodology and that met our quality threshold; that explored the views and experiences of routine ANC among healthy, pregnant and postnatal women or among healthcare providers offering this care, including doctors, midwives, nurses, lay health workers and traditional birth attendants; and that took place in any setting where ANC was provided.We excluded studies of ANC programmes designed for women with specific complications. We also excluded studies of programmes that focused solely on antenatal education., Data Collection and Analysis: Two authors undertook data extraction, logged study characteristics, and assessed study quality. We used meta-ethnographic and Framework techniques to code and categorise study data. We developed findings from the data and presented these in a 'Summary of Qualitative Findings' (SoQF) table. We assessed confidence in each finding using GRADE-CERQual. We used these findings to generate higher-level explanatory thematic domains. We then developed two lines of argument syntheses, one from service user data, and one from healthcare provider data. In addition, we mapped the findings to relevant Cochrane effectiveness reviews to assess how far review authors had taken account of behavioural and organisational factors in the design and implementation of the interventions they tested. We also translated the findings into logic models to explain full, partial and no uptake of ANC, using the theory of planned behaviour., Main Results: We include 85 studies in our synthesis. Forty-six studies explored the views and experiences of healthy pregnant or postnatal women, 17 studies explored the views and experiences of healthcare providers and 22 studies incorporated the views of both women and healthcare providers. The studies took place in 41 countries, including eight high-income countries, 18 middle-income countries and 15 low-income countries, in rural, urban and semi-urban locations. We developed 52 findings in total and organised these into three thematic domains: socio-cultural context (11 findings, five moderate- or high-confidence); service design and provision (24 findings, 15 moderate- or high-confidence); and what matters to women and staff (17 findings, 11 moderate- or high-confidence) The third domain was sub-divided into two conceptual areas; personalised supportive care, and information and safety. We also developed two lines of argument, using high- or moderate-confidence findings:For women, initial or continued use of ANC depends on a perception that doing so will be a positive experience. This is a result of the provision of good-quality local services that are not dependent on the payment of informal fees and that include continuity of care that is authentically personalised, kind, caring, supportive, culturally sensitive, flexible, and respectful of women's need for privacy, and that allow staff to take the time needed to provide relevant support, information and clinical safety for the woman and the baby, as and when they need it. Women's perceptions of the value of ANC depend on their general beliefs about pregnancy as a healthy or a risky state, and on their reaction to being pregnant, as well as on local socio-cultural norms relating to the advantages or otherwise of antenatal care for healthy pregnancies, and for those with complications. Whether they continue to use ANC or not depends on their experience of ANC design and provision when they access it for the first time.The capacity of healthcare providers to deliver the kind of high-quality, relationship-based, locally accessible ANC that is likely to facilitate access by women depends on the provision of sufficient resources and staffing as well as the time to provide flexible personalised, private appointments that are not overloaded with organisational tasks. Such provision also depends on organisational norms and values that overtly value kind, caring staff who make effective, culturally-appropriate links with local communities, who respect women's belief that pregnancy is usually a normal life event, but who can recognise and respond to complications when they arise. Healthcare providers also require sufficient training and education to do their job well, as well as an adequate salary, so that they do not need to demand extra informal funds from women and families, to supplement their income, or to fund essential supplies., Authors' Conclusions: This review has identified key barriers and facilitators to the uptake (or not) of ANC services by pregnant women, and in the provision (or not) of good-quality ANC by healthcare providers. It complements existing effectiveness reviews of models of ANC provision and adds essential insights into why a particular type of ANC provided in specific local contexts may or may not be acceptable, accessible, or valued by some pregnant women and their families/communities. Those providing and funding services should consider the three thematic domains identified by the review as a basis for service development and improvement. Such developments should include pregnant and postnatal women, community members and other relevant stakeholders.

Background: The publication of the World Health Organization (WHO) recommendations on antenatal care in 2016 introduced the perspective of women as a necessary component of clinical guidelines in maternity care. WHO highlights the crucial role played by evidence-based recommendations in promoting and supporting normal birth processes and a positive experience of pregnancy. This paper aims to explore and critically appraise recommendations of national antenatal care guidelines across European countries in comparison with the WHO guideline., Methods: We collected guidelines from country partners of the EU COST Action IS1405. Components of the documents structure and main recommendations within and between them were compared and contrasted with the WHO guideline on antenatal care with a particular interest in exploring whether and how women's experience was included in the recommendations., Results: Eight out of eleven countries had a single national guideline on antenatal care while three countries did not. National guidelines mostly focused on care of healthy women with a straightforward pregnancy. The level of concordance between the national and the WHO recommendations varied along a continuum from almost total concordance to almost total dissonance. Women's views and experiences were accounted for in some guidelines, but mostly not placed at the same level of importance as clinical items., Conclusions: Findings outline convergences and divergences with the WHO recommendations. They highlight the need for considering women's views more in the development of evidence-based recommendations and in practice for positive impacts on perinatal health at a global level, and on the experiences of each family.

Background: The most recent WHO recommendations "Intrapartum care for a positive childbirth experience" highlight the need to identify women-centered interventions and outcomes for intrapartum care, and to include service users' experiences and qualitative research into the assessment of maternity care. Babies Born Better (B3) is a trans-European survey designed to capture service user views and experiences of maternity care provision. Italian service users contributed to the survey., Methods: The B3 Survey is an anonymous, mixed-method online survey, translated into 22 languages. We separated out the Italian responses and analyzed them using computer-assisted qualitative software (MAXQDA) and SPSS and STATA for quantitative data analysis. Simple descriptives were used for the numeric data, and content analysis for the qualitative responses. Geomapping was based on the coded qualitative data and postcodes (using Tableau Public)., Results: There were 1000 respondents from every region of Italy, using a range of places of birth (hospital, birth center, home) and experiencing care with both midwives and obstetricians. Most identified positive experiences of care, as well as some practices they would like to change. Both positive and critical comments included provision of care based on the type of providers, clinical procedures, the birth environment, and breastfeeding support. There were clear differences in the geomapped data across Italian regions., Conclusions: Mothers highly value respectful, skilled and loving care that gives them a strong sense of personal achievement and confidence, and birth environments that support this. There was distinct variation in the percentage of positive comments made across Italian regions.

Background: There is continued debate about the role of women and communities in influencing rising rates of caesarean section (CS). In settings where CS rates exceed recommended levels, mothers and babies are exposed to potential harms that may outweigh the potential benefits. There is therefore a need to understand how educational interventions targeted at women and communities to reduce unnecessary CS are perceived and used. This qualitative evidence synthesis aimed to explore what women and communities say about the barriers and facilitators to intervention effectiveness for these important groups., Method: Seven electronic databases were searched using predefined search terms. Studies reporting qualitative data pertaining to interventions, published between 1985 and March 2017, with no language restriction were sought. Study quality was independently assessed by two authors before qualitative evidence synthesis was undertaken using an interpretive, meta-ethnography approach. Resulting Statements of Findings were assessed using GRADE-CERQual, and summarised thematically., Results: Twelve studies were included. They were published between 2001 and 2016. Eleven were from high-income countries. Twelve Summaries of Findings encompassed the data, and were graded (moderate or high) on CerQual. The Statements of Findings are reported under three final themes: 1) Mutability of women's and communities' beliefs about birth; 2) Multiplicity of individual information needs about birth; 3) Interactions with health professionals and influence of healthcare system on actual birth method. Women and communities value educational interventions that include opportunities for dialogue, are individualised (including acknowledgement of previous birth experiences), and are consistent with available clinical care and the advice of the health professional they come into contact with., Conclusion: Women's values and preferences for birth, and for information format and content, vary across populations, and evolves in individual women over time. Interactions with health professionals and health system factors can partly be responsible for changes in views. Educational interventions should take into account these dynamic interactions, as well as the women's need for emotional support and dialogue with professionals alongside information about birth. Further research is required to test these findings and the utility of their practical application, particularly in medium and low income settings., Systematic Review Registration Number: PROSPERO 2017 CRD42017059453 .

Background: Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research. As a first step in identifying what might be making the difference we conducted a scoping review of interventions tested in RCTs in order to establish a taxonomy of antenatal care models., Methods: A protocol-driven systematic search was undertaken of databases for RCTs and SRs reporting antenatal care interventions. Results were unrestricted by time or locality, but limited to English language. Key characteristics of both experimental and control interventions in the included trials were mapped using SPIO (Study design; Population; Intervention; Outcomes) criteria and the intervention and principal outcome measures were described. Commonalities and differences between the components that were being tested in each study were identified by consensus, resulting in a comprehensive description of emergent models for antenatal care interventions., Results: Of 13,050 articles retrieved, we identified 153 eligible articles including 130 RCTs in 34 countries. The interventions tested in these trials varied from the number of visits to the location of care provision, and from the content of care to the professional/lay group providing that care. In most studies neither intervention nor control arm was well described. Our analysis of the identified trials of antenatal care interventions produced the following taxonomy: Universal provision model (for all women irrespective of health state or complications); Restricted 'lower-risk'-based provision model (midwifery-led or reduced/flexible visit approach for healthy women); Augmented provision model (antenatal care as in Universal provision above but augmented by clinical, educational or behavioural intervention); Targeted 'higher-risk'-based provision model (for woman with defined clinical or socio-demographic risk factors). The first category was most commonly tested in low-income countries (i.e. resource-poor settings), particularly in Asia. The other categories were tested around the world. The trials included a range of care providers, including midwives, nurses, doctors, and lay workers., Conclusions: Interventions can be defined and described in many ways. The intended antenatal care population group proved the simplest and most clinically relevant way of distinguishing trials which might otherwise be categorised together. Since our review excluded non-trial interventions, the taxonomy does not represent antenatal care provision worldwide. It offers a stable and reproducible approach to describing the purpose and content of models of antenatal care which have been tested in a trial. It highlights a lack of reported detail of trial interventions and usual care processes. It provides a baseline for future work to examine and test the salient characteristics of the most effective models, and could also help decision-makers and service planners in planning implementation.

Background: Implementing effective antenatal care models is a key global policy goal. However, the mechanisms of action of these multi-faceted models that would allow widespread implementation are seldom examined and poorly understood. In existing care model analyses there is little distinction between what is done, how it is done, and who does it. A new evidence-informed quality maternal and newborn care (QMNC) framework identifies key characteristics of quality care. This offers the opportunity to identify systematically the characteristics of care delivery that may be generalizable across contexts, thereby enhancing implementation. Our objective was to map the characteristics of antenatal care models tested in Randomised Controlled Trials (RCTs) to a new evidence-based framework for quality maternal and newborn care; thus facilitating the identification of characteristics of effective care., Methods: A systematic review of RCTs of midwifery-led antenatal care models. Mapping and evaluation of these models' characteristics to the QMNC framework using data extraction and scoring forms derived from the five framework components. Paired team members independently extracted data and conducted quality assessment using the QMNC framework and standard RCT criteria., Results: From 13,050 citations initially retrieved we identified 17 RCTs of midwifery-led antenatal care models from Australia (7), the UK (4), China (2), and Sweden, Ireland, Mexico and Canada (1 each). QMNC framework scores ranged from 9 to 25 (possible range 0-32), with most models reporting fewer than half the characteristics associated with quality maternity care. Description of care model characteristics was lacking in many studies, but was better reported for the intervention arms. Organisation of care was the best-described component. Underlying values and philosophy of care were poorly reported., Conclusions: The QMNC framework facilitates assessment of the characteristics of antenatal care models. It is vital to understand all the characteristics of multi-faceted interventions such as care models; not only what is done but why it is done, by whom, and how this differed from the standard care package. By applying the QMNC framework we have established a foundation for future reports of intervention studies so that the characteristics of individual models can be evaluated, and the impact of any differences appraised.

Unlabelled: BACKGROUND OR CONTEXT: refugee and asylum seekers are over represented in maternal death data. Many asylum seeking and refugee women access maternity care infrequently, or not at all. Little is known about the role of voluntary sector workers in supporting pregnant refugees and asylum seekers., Objective: to explore the experiences of voluntary sector workers supporting asylum seeking and refugee women during pregnancy and early motherhood., Design: a qualitative descriptive study., Setting and Participants: individual and focus group interviews in three large urban centres in North West England, United Kingdom., Findings: two main themes emerged. 'Literally through hell and back' reflected the experiences of suffering, abuse and loss recounted to the volunteers by many of the women they work with. ׳Bridging the unacknowledged gap' related to the invisible processes undertaken by the workers as they enable the women they work with to over come their marginalised position. This included the difficulties of transience, and lack of enculturation, and to support them in accessing maternity care., Conclusion: voluntary sector workers supporting asylum seeking and refugee women strongly identified with the extreme suffering experienced by many of the women they work with. Through this contact, they become acutely aware of the gaps in provision for such women, and developed unique and innovative approaches to bridge this gap. These findings highlight the need for maternity health system to actively collaborate with, and learn from, voluntary agencies working in this field to improve the support offered to asylum seeking and refugee women., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

In this first paper in a series of four papers on midwifery, we aimed to examine, comprehensively and systematically, the contribution midwifery can make to the quality of care of women and infants globally, and the role of midwives and others in providing midwifery care. Drawing on international definitions and current practice, we mapped the scope of midwifery. We then developed a framework for quality maternal and newborn care using a mixed-methods approach including synthesis of findings from systematic reviews of women's views and experiences, effective practices, and maternal and newborn care providers. The framework differentiates between what care is provided and how and by whom it is provided, and describes the care and services that childbearing women and newborn infants need in all settings. We identified more than 50 short-term, medium-term, and long-term outcomes that could be improved by care within the scope of midwifery; reduced maternal and neonatal mortality and morbidity, reduced stillbirth and preterm birth, decreased number of unnecessary interventions, and improved psychosocial and public health outcomes. Midwifery was associated with more efficient use of resources and improved outcomes when provided by midwives who were educated, trained, licensed, and regulated. Our findings support a system-level shift from maternal and newborn care focused on identification and treatment of pathology for the minority to skilled care for all. This change includes preventive and supportive care that works to strengthen women's capabilities in the context of respectful relationships, is tailored to their needs, focuses on promotion of normal reproductive processes, and in which first-line management of complications and accessible emergency treatment are provided when needed. Midwifery is pivotal to this approach, which requires effective interdisciplinary teamwork and integration across facility and community settings. Future planning for maternal and newborn care systems can benefit from using the quality framework in planning workforce development and resource allocation., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Antenatal care can play an important role in the prevention of preterm birth. Evaluation of antenatal care is usually based on the number of visits rather than the content of care, using tools such as the Adequacy of Prenatal Care Use index. This article presents an analysis of the relation between specific elements of antenatal care and the risk of preterm birth compared with considering the number of visits only., Methods: A prospective cohort study was conducted in the Brussels Metropolitan Region. In all, 333 women were consecutively recruited at the beginning of their antenatal care trajectory and followed until birth. Information on timing and content for every visit was recorded by structured interview. A new tool was developed to measure the antenatal care trajectory, which included Content and Timing of care in Pregnancy (CTP). Odds ratios (OR) (adjusted and unadjusted) for preterm birth were calculated for the Adequacy of Prenatal Care Use and CTP model., Results: The number of visits alone was not associated with preterm birth. In contrast, a significant association was found between the content and timing of care and preterm birth. Compared with the CTP lowest ('inadequate') category, women in the CTP 'sufficient' (OR 0.30; 95% CI 0.09-0.94) and CTP 'appropriate' (OR 0.21; 95% CI 0.06-0.68) category had a lower risk., Conclusions: This study suggests that measurement of the content and timing of care of antenatal care using the new CTP tool is a better assessment of the risk of preterm birth than assessment of the number of antenatal visits alone.

Background: Almost 50% of women in low- and middle-income countries (LMICs) don't receive adequate antenatal care. Women's views can offer important insights into this problem. Qualitative studies exploring inadequate use of antenatal services have been undertaken in a range of countries, but the findings are not easily transferable. We aimed to inform the development of future antenatal care programmes through a synthesis of findings in all relevant qualitative studies., Methods and Findings: Using a predetermined search strategy, we identified robust qualitative studies reporting on the views and experiences of women in LMICs who received inadequate antenatal care. We used meta-ethnographic techniques to generate themes and a line-of-argument synthesis. We derived policy-relevant hypotheses from the findings. We included 21 papers representing the views of more than 1,230 women from 15 countries. Three key themes were identified: "pregnancy as socially risky and physiologically healthy", "resource use and survival in conditions of extreme poverty", and "not getting it right the first time". The line-of-argument synthesis describes a dissonance between programme design and cultural contexts that may restrict access and discourage return visits. We hypothesize that centralised, risk-focused antenatal care programmes may be at odds with the resources, beliefs, and experiences of pregnant women who underuse antenatal services., Conclusions: Our findings suggest that there may be a misalignment between current antenatal care provision and the social and cultural context of some women in LMICs. Antenatal care provision that is theoretically and contextually at odds with local contextual beliefs and experiences is likely to be underused, especially when attendance generates increased personal risks of lost family resources or physical danger during travel, when the promised care is not delivered because of resource constraints, and when women experience covert or overt abuse in care settings.

Background: Current measures of antenatal care use are limited to initiation of care and number of visits. This study aimed to describe the development and application of a tool to assess the adequacy of the content and timing of antenatal care., Methods: The Content and Timing of care in Pregnancy (CTP) tool was developed based on clinical relevance for ongoing antenatal care and recommendations in national and international guidelines. The tool reflects minimal care recommended in every pregnancy, regardless of parity or risk status. CTP measures timing of initiation of care, content of care (number of blood pressure readings, blood tests and ultrasound scans) and whether the interventions were received at an appropriate time. Antenatal care trajectories for 333 pregnant women were then described using a standard tool (the APNCU index), that measures the quantity of care only, and the new CTP tool. Both tools categorise care into 4 categories, from 'Inadequate' (both tools) to 'Adequate plus' (APNCU) or 'Appropriate' (CTP). Participants recorded the timing and content of their antenatal care prospectively using diaries. Analysis included an examination of similarities and differences in categorisation of care episodes between the tools., Results: According to the CTP tool, the care trajectory of 10,2% of the women was classified as inadequate, 8,4% as intermediate, 36% as sufficient and 45,3% as appropriate. The assessment of quality of care differed significantly between the two tools. Seventeen care trajectories classified as 'Adequate' or 'Adequate plus' by the APNCU were deemed 'Inadequate' by the CTP. This suggests that, despite a high number of visits, these women did not receive the minimal recommended content and timing of care., Conclusions: The CTP tool provides a more detailed assessment of the adequacy of antenatal care than the current standard index. However, guidelines for the content of antenatal care vary, and the tool does not at the moment grade over-use of interventions as 'Inappropriate'. Further work needs to be done to refine the content items prior to larger scale testing of the impact of the new measure.

Background: The World Health Organization (WHO) recommends one ultrasound scan before 24 weeks gestation as part of routine antenatal care (WHO 2016). We explored influences on provision and uptake through views and experiences of pregnant women, partners, and health workers. Methods: We undertook a systematic review (PROSPERO CRD42021230926). We derived summaries of findings and overarching themes using metasynthesis methods. We searched MEDLINE, CINAHL, PsycINFO, SocIndex, LILACS, and AIM (Nov 25th 2020) for qualitative studies reporting views and experiences of routine ultrasound provision to 24 weeks gestation, with no language or date restriction. After quality assessment, data were logged and analysed in Excel. We assessed confidence in the findings using Grade-CERQual. Findings: From 7076 hits, we included 80 papers (1994–2020, 23 countries, 16 LICs/MICs, over 1500 participants). We identified 17 review findings, (moderate or high confidence: 14/17), and four themes: sociocultural influences and expectations; the power of visual technology; joy and devastation: consequences of ultrasound findings; the significance of relationship in the ultrasound encounter. Providing or receiving ultrasound was positive for most, reportedly increasing parental-fetal engagement. However, abnormal findings were often shocking. Some reported changing future reproductive decisions after equivocal results, even when the eventual diagnosis was positive. Attitudes and behaviours of sonographers influenced service user experience. Ultrasound providers expressed concern about making mistakes, recognising their need for education, training, and adequate time with women. Ultrasound sex determination influenced female feticide in some contexts, in others, termination was not socially acceptable. Overuse was noted to reduce clinical antenatal skills as well as the use and uptake of other forms of antenatal care. These factors influenced utility and equity of ultrasound in some settings. Conclusion: Though antenatal ultrasound was largely seen as positive, long-term adverse psychological and reproductive consequences were reported for some. Gender inequity may be reinforced by female feticide following ultrasound in some contexts. Provider attitudes and behaviours, time to engage fully with service users, social norms, access to follow up, and the potential for overuse all need to be considered. [ABSTRACT FROM AUTHOR]

Introduction: Design and provision of good quality maternity care should incorporate what matters to childbearing women. This qualitative systematic review was undertaken to inform WHO intrapartum guidelines. Methods: Using a pre-determined search strategy, we searched Medline, CINAHL, PsycINFO, AMED, EMBASE, LILACS, AJOL, and reference lists of eligible studies published 1996-August 2016 (updated to January 2018), reporting qualitative data on womens’ childbirth beliefs, expectations, and values. Studies including specific interventions or health conditions were excluded. PRISMA guidelines were followed. Data collection and analysis: Authors’ findings were extracted, logged on a study-specific data form, and synthesised using meta-ethnographic techniques. Confidence in the quality, coherence, relevance and adequacy of data underpinning the resulting themes was assessed using GRADE-CERQual. A line of argument synthesis was developed. Results: 35 studies (19 countries) were included in the primary search, and 2 in the update. Confidence in most results was moderate to high. What mattered to most women was a positive experience that fulfilled or exceeded their prior personal and socio-cultural beliefs and expectations. This included giving birth to a healthy baby in a clinically and psychologically safe environment with practical and emotional support from birth companions, and competent, reassuring, kind clinical staff. Most wanted a physiological labour and birth, while acknowledging that birth can be unpredictable and frightening, and that they may need to ‘go with the flow’. If intervention was needed or wanted, women wanted to retain a sense of personal achievement and control through active decision-making. These values and expectations were mediated through womens’ embodied (physical and psychosocial) experience of pregnancy and birth; local familial and sociocultural norms; and encounters with local maternity services and staff. Conclusions: Most healthy childbearing women want a positive birth experience. Safety and psychosocial wellbeing are equally valued. Maternity care should be designed to fulfil or exceed womens’ personal and socio-cultural beliefs and expectations. [ABSTRACT FROM AUTHOR]

The aim of this paper was to describe the first person perspective of being a peer midwife and a novice researcher initiating collaborative AR in her own organization to develop knowledge about the first encounters between the labouring woman and her care-givers in a hospital birthing context. It was motivated by the author’s longstanding professional clinical experience of observing and hearing parents’ stories of vulnerability and fear of childbirth, and how staff’s attitudes affected the childbirth experience negatively. Data were collected between 2010 and 2013 and included the researcher’s log with reflections from clinical work, as well as interviews, participant observation, and research group communications. A reflective interpretative lifeworld research approach was used to analyze the data. The experience of being a novice insider action researcher (IARr) consisted of three thematic meanings: “the struggle to initiate a clinical insider action research project,” “standing alone at the messy front line,” and “being a catalytic counterbalance to the prevailing medico technical focus.” The comprehensive understanding was “learning how to clinically reflect on and to voice the tacit components of care.” The strategy used in undertaking this study was influenced by the philosophies of both midwifery care and AR. [ABSTRACT FROM AUTHOR]

Background: Using patient-reported outcome measures (PROMs) to assess Quality of Life (QoL) is well established, but commonly-used PROM item-sets do not necessarily capture what all respondents consider important. Measuring complex constructs is particularly difficult in randomised controlled trials (RCTs). The Mother-Generated Index (MGI) is a validated antenatal and postnatal QoL instrument in which the variables and scores are completely respondent-driven. This paper reports on the feasibility and acceptability of the MGI in an RCT, and compares the resulting variables and QoL scores with more commonly used instruments.Methods: The single-page MGI was included at the end of a ten page questionnaire pack and posted to the RCT participants at baseline (28-32 weeks' gestation) and follow-up (six weeks postnatal). Feasibility and acceptability were assessed by ease of administration, data entry and completion rates. Variables cited by women were analysed thematically. MGI QoL scores were compared with outcomes from the EQ-5D-3 L; Edinburgh Postnatal Depression Scale; Satisfaction With Life Scale; and State Trait Anxiety Inventory.Results: Six hundred and seventy eight pregnant women returned the pack at baseline; 668 completed the MGI (98.5%); 383/400 returns at follow up included a completed MGI (95.7%). Quantitative data were scanned into SPSS using a standard data scanning system, and were largely error-free; qualitative data were entered manually. The variables recorded by participants on the MGI forms incorporated many of those in the comparison instruments, and other outcomes commonly used in intrapartum trials, but they also revealed a wider range of issues affecting their quality of life. These included financial and work-related worries; moving house; and concerns over family illness and pets. The MGI scores demonstrated low-to-moderate correlation with other tools (all r values p < .01).Conclusions: Without face-to-face explanation and at the end of a long questionnaire, the MGI was feasible to use, and acceptable to RCT participants. It allowed individual participants to include issues that were important to them, but which are not well captured by existing tools. The MGI unites the explanatory power of qualitative research with the comparative power of quantitative designs, is inexpensive to administer, and requires minimal linguistic and conceptual translation.Trial Registration: ISRCTN27575146 (date assigned 23 March 2011). [ABSTRACT FROM AUTHOR]