Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool.

BACKGROUND: Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants' views and experiences of trial interventions and related quality of life. Purely quantitative approaches lack the necessary detail and flexibility to understand the real-world impact of study interventions on participants, according to their own priorities. Conversely, purely qualitative assessments are time consuming and usually restricted to a small, possibly unrepresentative, sub-sample. This paper, which reports a pilot study within a randomised controlled trial of induction of labour, reports the feasibility, and acceptability of the Participant-Generated Experience and Satisfaction (PaGES) Index, a new mixed qualitative / quantitative PREM tool. METHODS: The single-sheet PaGES Index was completed by hypertensive pregnant women in two hospitals in Nagpur, India before and after taking part in the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) randomised controlled trial. Participants recorded aspects of the impending birth they considered most important, and then ranked them. After the birth, participants completed the PaGES Index again, this time also scoring their satisfaction with each item. Forms were completed on paper in the local language or in English, supported by Research Assistants. Following translation (when needed), responses were uploaded to a REDCap database, coded in Excel and analysed thematically. A formal qualitative evaluation (qMOLI) was also conducted to obtain stakeholder perspectives of the PaGES Index and the wider trial. Semi-structured interviews were conducted with participants, and focus groups with researchers and clinicians. Data were managed using NVivo 12 software and analysed using the framework approach. RESULTS: Participants and researchers found the PaGES Index easy to complete and administer; mothers valued the opportunity to speak about their experience. Qualitative analysis of the initial 68 PaGES Index responses identified areas of commonality and difference among participants and also when comparing antenatal and postnatal responses. Theme citations and associated comments scores were fairly stable before and after the birth. The qMOLI phase, comprising 53 one-to-one interviews with participants and eight focus groups involving 83 researchers and clinicians, provided support that the PaGES Index was an acceptable and even helpful means of capturing participant perspectives. CONCLUSIONS: Subjective participant experiences are an important aspect of clinical trials. The PaGES Index was found to be a feasible and acceptable measure that unites qualitative research's explanatory power with the comparative power of quantitative designs. It also offers the opportunity to conduct a before-and-after evaluation, allowing researchers to examine the expectations and actual experiences of all clinical trial participants, not just a small sub-sample. This study also shows that, with appropriate research assistant input, the PaGES Index can be used in different languages by participants with varying literacy levels. TRIAL REGISTRATION: Clinical Trials.gov (21/11/2018) (NCT03749902).

Transforming the Quality Maternal Newborn Care Framework into an index to measure the quality of maternity care.

BACKGROUND: The Quality Maternal and Newborn Care (QMNC) Framework describes the care that childbearing women and newborn infants need in all settings. It comprises five components and was designed for use in planning, workforce development, and resource allocation, aimed at improving the quality and cost effectiveness of maternal and newborn care globally. The purpose of this paper is to describe the first phase of a project designed to transform the Framework into a quantitative tool for service user assessment of the quality of maternity care. METHODS: Each component of the original Framework content was developed into a draft service user questionnaire and distributed to an expert panel, drawn from a range of low-, middle-, and high-resource countries. The panel consisted of five Framework authors, nine midwife researchers, six midwives, and five service user (consumer) advocates. Two rounds of discussion and revision were undertaken with the expert panel who commented on the importance, relevance and clarity of questions, and then on their necessity, wording, and order. A third round involved two experts in survey design. RESULTS: Following 24 responses in the first round, the questions were refined and returned to the panel. After incorporating the second-round comments from 16 experts, the survey was then sent to two experts in questionnaire design and construction. Face validity was affirmed through this consultative process. CONCLUSIONS: Despite Covid-19 pandemic-related restrictions, this robust iterative consultative process with an international expert panel has resulted in the prototype QMNC Framework index (QMNCFi)-a questionnaire designed for use in diverse settings to assess the quality of maternity care. The QMNCFi's psychometric properties are now being tested in an international online survey.

Understanding factors affecting breastfeeding practices in one city in the Kingdom of Saudi Arabia: an interpretative phenomenological study.

BACKGROUND: Breastfeeding duration has declined in the Kingdom of Saudi Arabia (KSA) in recent decades, although accurate national data about different breastfeeding indicators by infant age are lacking. This qualitative study, the first in KSA, aimed to understand the factors affecting mothers' decisions and experiences regarding any breastfeeding practices. METHODS: A qualitative phenomenological approach was used to investigate mothers' experiences of breastfeeding. Non-probability convenience sampling and snowballing strategies were designed to recruit participants. Semi-structured interviews were conducted with 16 mothers, from two hospitals and three primary health clinics in Al-Madinah city, from December 2017 to March 2018. Interpretative phenomenological analysis was the analysis framework. RESULTS: Three themes were identified: 1) 'Up against the system': policies, staff and systems were the main barriers to exclusive breastfeeding; 2) 'Social support and negativity': family support in the first 40 postpartum days protected breastfeeding continuation and was highly appreciated, but negative comments limited breastfeeding practices thereafter; and 3) 'Managing tensions': mothers' religious beliefs about breastfeeding boosted their decisions; however, the challenge of managing tensions influenced mothers to stop breastfeeding earlier than they wished. The study revealed that mothers had no doubts about wanting to breastfeed their babies; but continuation was adversely affected by unhelpful hospital policies and staff actions, the lack of ongoing social support, and by others people's negativity, rather than by the mothers' own views. Stopping breastfeeding earlier than planned was a complex decision for most mothers. However, mothers said that they intended to breastfeed their next baby successfully. CONCLUSIONS: Healthcare professionals (maternity staff, paediatricians and pharmacists) need education and training to support exclusive breastfeeding effectively. Increasing the number of hospitals with Baby Friendly Hospital Initiative accreditation, which includes staff practice changes, is needed to protect and support exclusive breastfeeding. Ongoing professional and peer support, and improving conditions at workplaces and universities, are needed to help mothers to continue breastfeeding successfully. Effective, coordinated national policies can support mothers' decisions in relation to breastfeeding. Such changes will reduce the tensions experienced by women and help them to achieve their breastfeeding goals and to breastfeed for longer.

An integrative literature review of psychosocial factors in the transition to parenthood following non-donor-assisted reproduction compared with spontaneously conceiving couples.

The paper reports an integrative literature review of research into the psychosocial factors which shape the transition to parenthood in couples following non-donor in vitro fertilization in comparison with those conceiving spontaneously. Nineteen papers of non-donor IVF and SC mothers and fathers were included. Differences between groups were reported for a range of psychosocial measures during the transition from pregnancy to parenthood including: the control couples feel they have over their lives (locus of control), parental adjustment and child behaviour, parental stress, parental investment in the child, self-esteem and self-efficacy, greater levels of protectiveness (separation anxiety) towards child, marital and family functioning, family alliance, marital satisfaction and communication, as well as anxiety, indirect aggression and lowered respect for the child. We have conceptualised these differences as three substantive themes which reflect psychosocial factors shaping transition to parenthood in parents after non-donor AR: namely social support, relationships and emotional well-being, which are in turn influenced by gender differences. These findings have implications for health care professionals' assessment of individual couples' support needs.

Process lessons from evaluating a combined continuity of carer and home birth scheme.

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

Qualitative evaluation of an innovative midwifery continuity scheme: Lessons from using a quality care framework.

INTRODUCTION: Innovative midwifery schemes must be robustly evaluated to establish whether they should be modified or can be replicated. Assessing quality of care can help to ascertain a scheme's acceptability and effectiveness. We used an established quality care framework as a benchmark in our qualitative evaluation of a combined continuity of caregiver and planned home birth scheme in Scotland. METHODS: Qualitative evaluation of stakeholder perceptions using the Quality Maternal and Newborn Care Framework was the basis for six focus groups and two one-to-one interviews with stakeholders (new mothers, partners, midwives). A thematic analytical approach was used. RESULTS: The qualitative evaluation found universal approval among participants. Flexible working patterns helped to nurture positive relationships, and information and support were highly valued. The principal themes-Organization of Care/Work Culture; Information and Support; Relationships-were strongly inter-related. They shared several subthemes, notably continuity of caregiver, flexible family-centered care, and the benefits of being at home. Flexibility and mutual respect helped women to express autonomy and develop agency. Women related their birth experiences to friends, family, and colleagues, thereby helping to normalize home birth. CONCLUSIONS: This qualitative evaluation of an innovative scheme used an established quality framework as a benchmark against which to assess stakeholder experiences. This approach helped to identify the critical codependence of factors involved in care delivery, which in turn helps to identify lessons for others considering similar schemes. Although our evaluation relates to one specific scheme, identifying the scheme's critical quality care aspects may assist others when planning similar schemes.

Exploring the qualities of midwifery-led continuity of care in Australia (MiLCCA) using the quality maternal and newborn care framework.

PROBLEM: Midwifery-led continuity of care has well documented evidence of benefits for mothers and babies, however uptake of these models by Australian maternity services has been slow. BACKGROUND: It is estimated that only 10% of women have access to midwifery-led continuity of care in Australia. The Quality Maternal Newborn Care (QMNC) Framework has been developed as a way to implement and upscale health systems that meet the needs of childbearing women and their infants. The Framework can be used to explore the qualities of existing maternity services. AIM: We aimed to use the QMNC Framework to explore the qualities of midwifery-led continuity of care in two distinct settings in Australia with recommendations for replication of the model in similar settings. METHODS: Data were collected from services users and service providers via focus groups. Thematic analysis was used to develop initial findings that were then mapped back to the QMNC Framework. FINDINGS: Good quality care was facilitated by Fostering connection, Providing flexibility for women and midwives and Having a sense of choice and control. Barriers to the provision of quality care were: Contested care and Needing more preparation for unexpected outcomes. DISCUSSION: Midwifery-led continuity of carer models shift the power dynamic from a hierarchical one, to one of equality between women and midwives facilitating informed decision making. There are ongoing issues with collaboration between general practice, obstetrics and midwifery. Organisations have a responsibility to address the challenges of contested care and to prepare women for all possible outcomes to ensure women experience the best quality care as described in the framework. CONCLUSION: The QMNC Framework is a useful tool for exploring the facilitators and barriers to the widespread provision of midwifery-led continuity of care.

Counselling interventions to enable women to initiate and continue breastfeeding: a systematic review and meta-analysis.

Background: Many infants worldwide are not breastfeeding according to WHO recommendations and this impacts on the health of women and children. Increasing breastfeeding is identified as a priority area supported by current policy targets. However, interventions are complex and multi-component and it is unclear which elements of interventions are most effective to increase breastfeeding in which settings. Breastfeeding counselling is often part of complex interventions but evidence is lacking on the specific effect of counselling interventions on breastfeeding practices. The aim of this systematic review is to examine evidence on effectiveness of breastfeeding counselling to inform global guidelines. Methods: A systematic search was conducted of six electronic databases in January 2018. Randomised controlled trials comparing breastfeeding counselling with no breastfeeding counselling or different formulations of counselling were included if they measured breastfeeding practices between birth and 24 months after birth. Results: From the 5180 records identified in searches and a further 11 records found by hand searching, 63 studies were included. Of these, 48 were individually-randomised trials and 15 were cluster-randomised trials. A total of 69 relevant comparisons were reported involving 33,073 women. There was a significant effect of counselling interventions on any breastfeeding at 4 to 6 weeks (Relative risk [RR] 0.85, 95% CI 0.77, 0.94) and 6 months (RR 0.92, 95% CI 0.87, 0.94). Greater effects were found on exclusive breastfeeding at 4 to 6 weeks (RR 0.79, 95% CI 0.72, 0.87) and 6 months (RR 0.84, 95% CI 0.78, 0.91). Counselling delivered at least four times postnatally is more effective than counselling delivered antenatally only and/or fewer than four times. Evidence was mostly of low quality due to high or unclear risk of bias of the included trials and high heterogeneity. Conclusions: Breastfeeding counselling is an effective public health intervention to increase rates of any and exclusive breastfeeding. Breastfeeding counselling should be provided face-to-face, and in addition, may be provided by telephone, both antenatally and postnatally, to all pregnant women and mothers with young children. To inform scale-up globally there is a need to further understand the elements of breastfeeding interventions such as counselling and their effectiveness in different contexts and circumstances. Study registration: This systematic review was registered in Prospero (CRD42018086494).

Using a quality care framework to evaluate user and provider experiences of maternity care: A comparative study.

OBJECTIVE: The Quality Maternal and Newborn Care Framework describes the components and characteristics of quality care and emphasises relational and continuity elements. Continuity of care is increasingly a focus of maternity care policy in the United Kingdom. While some outcomes have been shown to be improved, there is uncertainty about why certain models of care are more effective. Our overall objective is to develop a maternity care evaluation toolkit which incorporates this Framework along with other outcome evaluations. An initial step in developing this toolkit was to use the adapted Framework to evaluate perceptions and experiences of maternity care. Our specific objective in this study was to test this adapted Framework in a series of focus groups with key stakeholders, and to compare findings between different groups. Findings related to service users (pregnant women and new mothers) are reported in our accompanying paper; this paper presents findings from focus groups with service providers (midwives and obstetricians), and then compares user and provider perspectives. DESIGN: A qualitative comparative enquiry involving three focus groups with 26 midwives (eight newly qualified; eight working in a community midwifery unit; and ten senior tertiary-based) and two focus groups with twelve obstetricians of all grades. We used a six-phase thematic analysis to derive then compare the focus groups' principal sub-themes; we then mapped these to the original Quality Maternal and Newborn Care Framework and compared these service providers' responses with those from the pregnant women and new mothers. SETTING: Two health boards in Scotland. PARTICIPANTS: Midwives and obstetricians who had experience of various models of maternity care. FINDINGS: There were significant areas of overlap in their perceptions of providing maternity care. All groups reported 'limited resources and time'; the community midwifery unit and senior midwives and one group of obstetricians provided a critique of the system. Achieving tailored care was acknowledged as a problem by the senior midwives and one group of obstetricians. Only obstetricians discussed strategies for improvement. The newly qualified midwives were most positive in their responses. There was both overlap and contrast when comparing the views of service users and providers. We found most agreement when participants discussed some of the Framework's characteristics of care in negative terms, such as (in) accessible care, (lack of) adequate resources, and (absence of) tailored care. KEY CONCLUSIONS: Being able firstly to map the participants' responses to the Quality Maternal and Newborn Care Framework, and then to identify strengths and gaps in the provision of quality maternity care, suggests to us that the Framework, derived as it is from a comprehensive analysis of the global evidence on quality care, can indeed be used to inform an evaluation toolkit. While aware that we cannot generalise from this limited qualitative study, we are currently undertaking similar work in other countries by which we hope to confirm our findings and further develop the toolkit.

Using the Quality Maternal and Newborn Care Framework to evaluate women's experiences of different models of care: A qualitative study.

OBJECTIVE: There is evidence that continuity of care - increasingly a focus of maternity care policy in the UK - contributes to improved outcomes. However, uncertainty remains about which models of care are most effective in which circumstances, and why this is. A plausible explanation is grounded in the idea that the continuity elements of care contribute to and reinforce best quality care. The Quality Maternal and Newborn Care Framework describes the components and characteristics of quality care. As a first step in developing a maternity care evaluation toolkit, we adapted this Framework to see if it could be used to evaluate perceptions and experiences of different models of care. DESIGN: A qualitative comparative enquiry using focus groups. From a six-phase thematic analysis, we first derived then compared the principal sub-themes from the focus groups and mapped these to the original Framework. SETTING: Two health boards in Scotland. PARTICIPANTS: Pregnant women, new mothers, midwives and obstetricians who had experience of various models of maternity care. This paper reports findings from the pregnant women and new mothers. RESULTS: These are presented in two parts: the seven focus groups with pregnant women and new mothers are reported in this paper; the five focus groups with midwives and obstetricians in our accompanying paper. Those using the maternity services had experience of caseloading midwifery, 'modified universal provision' and 'high risk' models of maternity care. While women from all groups shared certain perspectives, those with experience of caseloading midwifery were consistently positive, reporting positive relationships, tailored care and effective communication. Women experiencing other models of care, especially the modified universal provision model, tended to report more negative relational experiences: lack of information, lack of tailored care, and anxiety and confusion. Timing of the focus group (i.e. during pregnancy or after the birth) appeared to make little difference to responses. Mapping responses to the Framework's characteristics of care was straightforward; mapping also showed how the Framework's components of care are interlinked. KEY CONCLUSIONS: Our adaptation of the Quality Maternal and Newborn Care Framework as a data collection tool allowed us to compare women with experience of different models of care, and relational factors were identifiable in many responses. Positive responses were found in all models but were most emphasised in the caseloading midwifery model, suggesting that the experience of caseloading continuity and its relational elements is highly valued. While further work is required to identify if this can be linked to improved clinical outcomes, we have established that the Quality Maternal and Newborn Care Framework can be adapted as an exploratory tool for assessing perceptions and experiences of maternity care.

Adapting the Quality Maternal and Newborn Care (QMNC) Framework to evaluate models of antenatal care: A pilot study.

BACKGROUND: Recent evidence indicates that continuity models of maternity care result in improved clinical and psychosocial outcomes, but their causal mechanisms are poorly understood. The recent Lancet Series on Midwifery's Quality Maternal and Newborn Care Framework describes five components of quality care and their associated characteristics. As an initial step in developing this Framework into an evaluation toolkit, we transformed its components and characteristics into a topic guide to assess stakeholder perceptions and experiences of care provided and received. The main purpose of this study was to assess the feasibility of this process. METHODS: We conducted twelve focus groups in two Scottish health board areas with 13 pregnant women, 18 new mothers, 26 midwives and 12 obstetricians who had experience of a range of different models of maternity care. Transcripts were analysed using a six-phase approach of thematic analysis. We mapped the identified themes and sub-themes back to the Framework. RESULTS: The emerging themes and sub-themes demonstrated the feasibility of using the QMNC framework as a data collection tool, and as a lens for analysing the data. Of the four emerging themes, only Organisation Culture / Work Structure' mapped directly to a single Framework component. The others-'Relationships'; 'Information and support'; and 'Uncertainty'-mapped to between two and five components, illustrating the interconnectedness of the Framework's components. Some negative sub-themes mirrored positive Framework characteristics of care. Some re-phrasing and re-ordering of the topic guides in later focus groups ensured we could cover all aspects of the Framework adequately. CONCLUSION: Adapting the Quality Maternal and Newborn Care Framework enabled us to focus on aspects of care which worked well and which didn't work well for these key stakeholders. Identifying 'what works for whom and why' in different models of care is a necessary step in reinforcing and replicating the most effective models of care.

Infant and young child feeding in emergencies: Organisational policies and activities during the refugee crisis in Lebanon.

Appropriate infant and young child feeding (IYCF) is key to reducing mortality amongst children aged under 2. Facilitating adherence to recommended IYCF practices during emergencies includes having relevant policies to support breastfeeding and complementary feeding as well as regulating the distribution of breast milk substitutes. In the current crisis, more than 1.2 million Syrian refugees are in Lebanon and it is timely to examine organisational IYCF policies and programmes. One hundred and thirty-five non-governmental organisations providing humanitarian aid in Lebanon were invited to participate in an online survey about organisational policies and programmatic activities on IYCF. Responses were obtained from 54 organisations: 29 International Non-Governmental Organisations (INGOs) and 25 Local Non-Governmental Organisations (LNGOs). In total, 8 (15%) reported having a written policy on IYCF, but only 1 policy (in draft format) was available for inspection. Twelve (8 INGOs and 4 LNGOs) indicated endorsing an external IYCF policy, but only 6 listed a valid policy. Four organisations (3 INGOs and 1 LNGO) had programme objectives that indicate protection, promotion, and support of IYCF. Three LNGOs reported receiving infant formula donations and 5 organisations (2 INGOs and 3 LNGOs) indicated distributing infant formula; 2 (1 INGO and 1 LNGO) did so in accordance with international and national policies. Few organisations violated IYCF guidance but organisational policies and activities on IYCF are not well established. In order to improve response in the current refugee crisis in Lebanon, there is a need to ensure policies are in place and implemented so that interventions support, promote, and protect IYCF.

Antenatal care trial interventions: a systematic scoping review and taxonomy development of care models.

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.

Peri-conceptual and mid-pregnancy drinking: a cross-sectional assessment in two Scottish health board areas using a 7-day Retrospective Diary.

AIMS: The aim of this study was to evaluate the use of a 7-day Retrospective Diary to assess peri-conceptual and mid-pregnancy alcohol consumption. BACKGROUND: Alcohol consumption among women has increased significantly and is of international concern. Heavy episodic ('binge') drinking is commonplace and is associated with unintended pregnancy. Pre-pregnancy drinking is strongly associated with continued drinking in pregnancy. Routine antenatal assessment of alcohol history and current drinking is variable; potentially harmful peri-conceptual drinking may be missed if a woman reports low or no drinking during pregnancy. DESIGN: Cross-sectional study (n = 510) in two Scottish health board areas. METHODS: Face-to-face Retrospective Diary administration from February to June 2015 assessing alcohol consumption in peri-conceptual and mid-pregnancy periods. Women were recruited at the mid-pregnancy ultrasound clinic. RESULTS: Of 510 women, 470 (92·0%) drank alcohol before their pregnancy; 187 (39·9%) drank every week. Retrospective assessment of peri-conceptual consumption identified heavy episodic drinking (more than six units on one occasion) in 52·2% (n = 266); 19·6% (n = 100) reported drinking more than 14 units per week, mostly at the weekend; 'mixing' of drinks was associated with significantly higher consumption. While consumption tailed off following pregnancy recognition, 5·5% (n = 28) still exceeded the recommended daily two-unit limit in pregnancy. Multivariable logistic regression identified that women who 'binged' peri-conceptually were 3·2 times more likely to do this. CONCLUSION: Statistically significant peri-conceptual consumption levels suggest a substantial proportion of alcohol-exposed pregnancies before pregnancy recognition. Not taking a detailed alcohol history, including patterns of consumption, will result in under-detection of alcohol-exposed pregnancies. The Retrospective Diary offers practitioners a detailed way of enquiring about alcohol history for this population.

Evaluation of a retrospective diary for peri-conceptual and mid-pregnancy drinking in Scotland: a cross-sectional study.

INTRODUCTION: Heavy episodic ("binge") drinking among women in Scotland is commonplace; prepregnancy drinking is associated with continued antenatal drinking. Evidence for effectiveness of standardized antenatal alcohol assessment is lacking. Alcohol-exposed pregnancies may be missed. We assessed peri-conceptual and mid-pregnancy consumption using a week-long retrospective diary and standard alcohol questionnaires, and evaluated the agreement between these instruments. MATERIAL AND METHODS: Cross-sectional study in two Scottish health board areas involving 510 women attending mid-pregnancy ultrasound scan clinics. Face-to-face administration of alcohol retrospective diary and AUDIT or AUDIT-C assessed weekly and daily alcohol consumption levels and patterns. Depression-Anxiety-Stress Scale (DASS-21) assessed maternal wellbeing. A sub-sample (n = 30) provided hair for alcohol metabolite analysis. Pearson's correlation coefficient investigated associations between questionnaires and alcohol metabolite data. RESULTS: The response rate was 73.8%. The retrospective diary correlated moderately with AUDIT-C and AUDIT but elicited reports of significantly higher peri-conceptual consumption, (median unit consumption on "drinking days" 6.8; range 0.4-63.8). Additional "special occasions" consumption ranged from 1 to 125 units per week. Correlations between DASS-21 and retrospective diary were weak. Biomarker analysis identified three instances of hazardous peri-conceptual drinking. CONCLUSIONS: Women reported higher consumption levels when completing the retrospective diary, especially regarding peri-conceptual "binge" drinking. Routine clinical practice methods may not capture potentially harmful or irregular drinking patterns. Given the association between prepregnancy and antenatal drinking, and alcohol's known teratogenic effects, particularly in the first trimester, the retrospective diary may be a useful low-tech tool to gather information on alcohol intake patterns and levels.

Peri-Conceptual and Mid-Pregnancy Alcohol Consumption: A Comparison between Areas of High and Low Deprivation in Scotland.

BACKGROUND: Alcohol-related mortality and morbidity among women has increased over recent decades, especially in areas of higher deprivation. Pre-pregnancy alcohol use is associated with continued consumption in pregnancy. We assessed whether general population alcohol consumption patterns were reflected among pregnant women in two Scottish areas with different deprivation levels. METHODS: Cross-sectional study in two health boards (HB1, lower deprivation levels, n = 274; HB2, higher deprivation levels, n = 236), using face-to-face 7-day Retrospective Diary estimation of peri-conceptual and mid-pregnancy alcohol consumption. RESULTS: A greater proportion of women in HB2 (higher deprivation area) sometimes drank peri-conceptually, but women in HB1 (lower deprivation area) were more likely to drink every week (49.6 vs 29.7%; p < 0.001) and to exceed daily limits (6 units) at least once each week (32.1 vs 14.8%; p < 0.001). After pregnancy recognition, consumption levels fell sharply, but women in HB2 were more likely to drink above recommended daily limits (2 units) each week (2.5 vs 0.0%; p < 0.05). However, women in HB1 were more likely to drink frequently. Women with the highest deprivation scores in each area drank on average less than women with the lowest deprivation scores. CONCLUSIONS: Heavy episodic and frequent consumption was more common in the lower deprivation area, in contrast with general population data. Eliciting a detailed alcohol history at the antenatal booking visit, and not simply establishing whether the woman is currently drinking, is essential. Inconsistent messages about the effects of alcohol in pregnancy may have contributed to the mixed picture we found concerning peri-conceptual and mid-pregnancy alcohol consumption.

Midwifery-led antenatal care models: mapping a systematic review to an evidence-based quality framework to identify key components and characteristics of care.

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.

The feasibility and acceptability of using the Mother-Generated Index (MGI) as a Patient Reported Outcome Measure in a randomised controlled trial of maternity care.

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).

Translation and cultural adaptation of the Mother-Generated Index into Brazilian Portuguese: A postnatal quality of life study.

OBJECTIVE: quality of life issues are central to maternal health and well-being. Within the context of a study examining postnatal quality of life, we set out to translate into Brazilian Portuguese the Mother-Generated Index and ensure its cross-cultural adaption for use in a Brazilian context. DESIGN: the Mother-Generated Index, a subjective quality of life tool, underwent a validated process of translation and cultural adaptation: synthesis of two independently translated versions, back-translation and review by an expert committee was followed by testing of the preliminary tool with 30 mothers. SETTINGS: community-based study in city in north-eastern Brazil. PARTICIPANTS: 30 postpartum mothers, interviewed approximately 30 days after birth. FINDINGS: while the mothers understood the concept of identifying and scoring quality of life aspects, many did not grasp the concept behind the use of 'spending points' to produce a relative ranking of these aspects. We resolved this by giving the mothers 'spending beans' instead; beans are a regional food staple. This use of a physical 'currency' solved the problem. DISCUSSION: this modified approach was ratified by the committee of experts and used with success on a further sample of 91 mothers. The whole process aimed to ensure semantic equivalence of the translated tool, and following this process we concluded that face validity of the Brazilian Portuguese Mother-Generated Index was good. While considerable resources are required to ensure a robust process of translation and adaptation, this is necessary if valid and reliable tools are to be produced. IMPLICATIONS: We conclude that the Mother-Generated Index is a valid tool to measure quality of life among Brazilian postpartum mothers, as it allows a simple and understandable way of assessing the various dimensions involved in their quality of life. Moreover, the Mother-Generated Index can provide healthcare professionals the opportunity to become aware of all significant aspects of a woman's life after childbirth.