Methodological quality of 100 recent systematic reviews of health-related outcome measurement instruments: an overview of reviews.

PURPOSE: Systematic reviews evaluating and comparing the measurement properties of outcome measurement instruments (OMIs) play an important role in OMI selection. Earlier overviews of review quality (2007, 2014) evidenced substantial concerns with regards to alignment to scientific standards. This overview aimed to investigate whether the quality of recent systematic reviews of OMIs lives up to the current scientific standards. METHODS: One hundred systematic reviews of OMIs published from June 1, 2021 onwards were randomly selected through a systematic literature search performed on March 17, 2022 in MEDLINE and EMBASE. The quality of systematic reviews was appraised by two independent reviewers. An updated data extraction form was informed by the earlier studies, and results were compared to these earlier studies' findings. RESULTS: A quarter of the reviews had an unclear research question or aim, and in 22% of the reviews the search strategy did not match the aim. Half of the reviews had an incomprehensive search strategy, because relevant search terms were not included. In 63% of the reviews (compared to 41% in 2014 and 30% in 2007) a risk of bias assessment was conducted. In 73% of the reviews (some) measurement properties were evaluated (58% in 2014 and 55% in 2007). In 60% of the reviews the data were (partly) synthesized (42% in 2014 and 7% in 2007); evaluation of measurement properties and data syntheses was not conducted separately for subscales in the majority. Certainty assessments of the quality of the total body of evidence were conducted in only 33% of reviews (not assessed in 2014 and 2007). The majority (58%) did not make any recommendations on which OMI (not) to use. CONCLUSION: Despite clear improvements in risk of bias assessments, measurement property evaluation and data synthesis, specifying the research question, conducting the search strategy and performing a certainty assessment remain poor. To ensure that systematic reviews of OMIs meet current scientific standards, more consistent conduct and reporting of systematic reviews of OMIs is needed.

Pregnancy and birth complications and long-term maternal mental health outcomes: A systematic review and meta-analysis.

BACKGROUND: Few studies have examined the associations between pregnancy and birth complications and long-term (>12 months) maternal mental health outcomes. OBJECTIVES: To review the published literature on pregnancy and birth complications and long-term maternal mental health outcomes. SEARCH STRATEGY: Systematic search of Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (Embase), PsycInfo®, PubMed® and Web of Science from inception until August 2022. SELECTION CRITERIA: Three reviewers independently reviewed titles, abstracts and full texts. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and appraised study quality. Random-effects meta-analyses were used to calculate pooled estimates. The Meta-analyses of Observational Studies in Epidemiology (MOOSE) guidelines were followed. The protocol was prospectively registered on the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022359017). MAIN RESULTS: Of the 16 310 articles identified, 33 studies were included (3 973 631 participants). Termination of pregnancy was associated with depression (pooled adjusted odds ratio, aOR 1.49, 95% CI 1.20-1.83) and anxiety disorder (pooled aOR 1.43, 95% CI 1.20-1.71). Miscarriage was associated with depression (pooled aOR 1.97, 95% CI 1.38-2.82) and anxiety disorder (pooled aOR 1.24, 95% CI 1.11-1.39). Sensitivity analyses excluding early pregnancy loss and termination reported similar results. Preterm birth was associated with depression (pooled aOR 1.37, 95% CI 1.32-1.42), anxiety disorder (pooled aOR 0.97, 95% CI 0.41-2.27) and post-traumatic stress disorder (PTSD) (pooled aOR 1.75, 95% CI 0.52-5.89). Caesarean section was not significantly associated with PTSD (pooled aOR 2.51, 95% CI 0.75-8.37). There were few studies on other mental disorders and therefore it was not possible to perform meta-analyses. CONCLUSIONS: Exposure to complications during pregnancy and birth increases the odds of long-term depression, anxiety disorder and PTSD.

Selective outcome reporting in trials of behavioural health interventions in health psychology and behavioural medicine journals: a review.

Selective outcome reporting can result in overestimation of treatment effects, research waste, and reduced openness and transparency. This review aimed to examine selective outcome reporting in trials of behavioural health interventions and determine potential outcome reporting bias. A review of nine health psychology and behavioural medicine journals was conducted to identify randomised controlled trials of behavioural health interventions published since 2019. Discrepancies in outcome reporting were observed in 90% of the 29 trials with corresponding registrations/protocols. Discrepancies included 72% of trials omitting prespecified outcomes; 55% of trials introduced new outcomes. Thirty-eight percent of trials omitted prespecified and introduced new outcomes. Three trials (10%) downgraded primary outcomes in registrations/protocols to secondary outcomes in final reports; downgraded outcomes were not statistically significant in two trials. Five trials (17%) upgraded secondary outcomes to primary outcomes; upgraded outcomes were statistically significant in all trials. In final reports, three trials (7%) omitted outcomes from the methods section; three trials (7%) introduced new outcomes in results that were not in the methods. These findings indicate that selective outcome reporting is a problem in behavioural health intervention trials. Journal- and trialist-level approaches are needed to minimise selective outcome reporting in health psychology and behavioural medicine.

Using behavioral science to increase core outcome set use in trials.

OBJECTIVES: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials. METHODS: This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to COS use from four recently published studies examining COS use in trials. Barriers and facilitators were coded to the Capability, Opportunity, Motivation-Behavior (COM-B) model, which forms part of the Behavior Change Wheel. COM-B findings were mapped to intervention functions by two reviewers, and then mapped to behavior change techniques (BCTs). Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity ratings were used to reach consensus on intervention functions and BCTs. BCTs were operationalized using examples of tangible potential applications and were categorized based on similarity. RESULTS: Barriers and facilitators were identified for all capability, opportunity and motivation aspects of the COM-B model. Five intervention functions (education, training, enablement, persuasion, and modeling) and 15 BCTs were identified. Thirty-six BCT examples were developed, including providing information on benefits of COS for health research, and information choosing COS. BCT examples are categorized by approaches related to "workshops," "guidance," "audio/visual resources," and "other resources." CONCLUSION: Study findings represent diverse ways to potentially increase COS use in trials. Future work is needed to examine effects of these behavioral intervention components on COS use. If effective, increased use of COS can improve outcome reporting and minimize outcome heterogeneity and research waste.

Prenatal maternal cortisol, stress and anxiety, and childhood obesity at 5 years: a nested case-control study.

BACKGROUND: Paediatric obesity is a global public health issue. Prenatal maternal mental health is potentially implicated in the development of childhood obesity. This study examined associations between prenatal maternal cortisol, self-reported stress, anxiety and depression in the second trimester, and childhood overweight and obesity at 5 years of age. METHODS: A nested case-control study was conducted using data from the Irish prospective longitudinal birth cohort SCOPE BASELINE. Cases were children with overweight or obesity, operationalised as having a BMI z-score above +2 standard deviations. Controls were children with a BMI z-score between -0.5 and 0.5 standard deviations at 5 years of age. Two to one matching by sex was conducted. Thirty-eight cases and 83 sex-matched controls were included. Maternal serum cortisol concentration and self-reported stress, anxiety and depression were measured at 15 ± 1 and 20 ± 1 weeks gestation. Conditional logistic regression analyses were conducted to examine associations between prenatal maternal cortisol and self-reported stress, anxiety and depression, and childhood overweight and obesity. RESULTS: Despite some evidence for associations between anxiety and depression, and child BMI z-scores in univariate analyses, adjusted models indicated no associations between prenatal maternal stress (OR: 1.02, 95% CI: 0.94-1.12), anxiety (OR: 1.03, 95% CI: 0.97-1.09), depression (OR: 1.04, 95% CI: 0.91-1.19), or cortisol concentration (OR: 0.99, 95% CI: 0.99-1.00) and child BMI z-score. CONCLUSION: Our findings do not provide support for associations between foetal exposure during the second trimester of pregnancy and maternal cortisol, stress and anxiety, and childhood overweight or obesity at 5 years of age.

Pregnancy and birth complications associations with long-term adverse maternal mental health outcomes: a systematic review and meta-analysis protocol.

Background: Existing studies have established an association between pregnancy, birth complications, and mental health in the first few weeks postpartum. However, there is no clear understanding of whether pregnancy and birth complications increase the risk of adverse maternal mental outcomes in the longer term. Research on maternal adverse mental health outcomes following pregnancy and birth complications beyond 12 months postpartum is scarce, and findings are inconsistent. Objective: This systematic review and meta-analysis will examine the available evidence on the association between pregnancy and birth complications and long-term adverse maternal mental health outcomes. Methods and analysis: We will include cohort, cross-sectional, and case-control studies in which a diagnosis of pregnancy and/or birth complication (preeclampsia, pregnancy loss, caesarean section, preterm birth, perineal laceration, neonatal intensive care unit admission, major obstetric haemorrhage, and birth injury/trauma) was reported and maternal mental disorders (depression, anxiety disorders, bipolar disorders, psychosis, and schizophrenia) after 12 months postpartum were the outcomes. A systematic search of PubMed, Embase, CINAHL, PsycINFO, and Web of Science will be conducted following a detailed search strategy until August 2022. Three authors will independently review titles and abstracts of all eligible studies, extract data using pre-defined standardised data extraction and assess the quality of each study using the Newcastle-Ottawa Scale. We will use random-effects meta-analysis for each exposure and outcome variable to calculate overall pooled estimates using the generic inverse variance method. This systematic review will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Ethical consideration: The proposed systematic review and meta-analysis is based on published data; ethics approval is not required. The results will be presented at scientific meetings and publish in a peer-reviewed journal. PROSPERO registration: CRD42022359017.

Corrigendum: Longitudinal relations between parenting stress and child internalizing and externalizing behaviors: testing within-person changes, bidirectionality and mediating mechanisms.

[This corrects the article DOI: 10.3389/fnbeh.2022.942363.].

Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.

Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ' Understanding and experiences of the potential benefits of sharing qualitative data from trials', 'Concerns about qualitative data sharing', and ' Future guidance and funding'. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.

Reply to: "The partner-an underutilized facilitator to support healthy gestational weight gain".

Facilitators and barriers influencing weight management behaviours were identified in our meta-synthesis of qualitative research entitled "Facilitators and barriers influencing weight management behaviours during pregnancy: a meta-synthesis of qualitative research". This manuscript is in response to the letter submitted by Sparks et al. regarding that work. The authors highlight the importance of including partners into intervention design when addressing weight management behaviours. We agree with the authors that it is important to include partners into intervention design and further research is granted to identify facilitators and barriers affecting their influence over women. As per our findings, the influence of the social context goes beyond the partner and we suggest that future interventions should address other relevant people in women's contexts such as parents, other relatives, and close friends.

Teaching open and reproducible scholarship: a critical review of the evidence base for current pedagogical methods and their outcomes.

In recent years, the scientific community has called for improvements in the credibility, robustness and reproducibility of research, characterized by increased interest and promotion of open and transparent research practices. While progress has been positive, there is a lack of consideration about how this approach can be embedded into undergraduate and postgraduate research training. Specifically, a critical overview of the literature which investigates how integrating open and reproducible science may influence student outcomes is needed. In this paper, we provide the first critical review of literature surrounding the integration of open and reproducible scholarship into teaching and learning and its associated outcomes in students. Our review highlighted how embedding open and reproducible scholarship appears to be associated with (i) students' scientific literacies (i.e. students' understanding of open research, consumption of science and the development of transferable skills); (ii) student engagement (i.e. motivation and engagement with learning, collaboration and engagement in open research) and (iii) students' attitudes towards science (i.e. trust in science and confidence in research findings). However, our review also identified a need for more robust and rigorous methods within pedagogical research, including more interventional and experimental evaluations of teaching practice. We discuss implications for teaching and learning scholarship.

A systematic review of behaviour change techniques used in the context of stillbirth prevention.

BACKGROUND: Stillbirth is one of the most devastating pregnancy outcomes that families can experience. Previous research has associated a wide range of risk factors with stillbirth, including maternal behaviours such as substance use, sleep position and attendance and engagement with antenatal care. Hence, some preventive efforts have been focused on tackling the behavioural risk factors for stillbirth. This study aimed to identify the Behaviour Change Techniques (BCTs) used in behaviour change interventions tacking behavioural risk factors for stillbirth such as substance use, sleep position, unattendance to antenatal care and weight management. STUDY DESIGN: A systematic review of the literature was conducted in June 2021 and updated in November 2022 in five databases: CINHAL, Psyhinfo, SociIndex, PubMed and Web of Science. Studies published in high-income countries describing interventions designed in the context of stillbirth prevention, reporting stillbirth rates and changes in behaviour were eligible for inclusion. BCTs were identified using the Behaviour Change Technique Taxonomy v1. RESULTS: Nine interventions were included in this review identified in 16 different publications. Of these, 4 interventions focused on more than one behaviour (smoking, monitoring fetal movements, sleep position, care-seeking behaviours), one focused on smoking, three on monitoring fetal movements and one on sleep position. Twenty-seven BCTs were identified across all interventions. The most commonly used was "Information about health consequences" (n = 7/9) followed by "Adding objects to the environment" (n = 6/9). One of the interventions included in this review has not been assessed for efficacy yet, of the remaining eight, three showed results in the reduction of stillbirth rates. and four interventions produced behaviour change (smoking reductions, increased knowledge, reduced supine sleeping time). CONCLUSIONS: Our findings suggest that interventions designed to date have limited effects on the rates of stillbirth and utilise a limited number of BCTs which are mostly focused on information provision. Further research is necessary to design evidence base behaviour change interventions with a greater focus to tackle all the other factors influencing behaviour change during pregnancy (e.g.: social influence, environmental barriers).

Factors that shape recurrent miscarriage care experiences: findings from a national survey.

BACKGROUND: Learning what matters to women/couples with recurrent miscarriage (RM) is essential to inform service improvement efforts and future RM care practices. Previous national and international surveys have examined inpatient stays, maternity care, and care experiences around pregnancy loss, but there is little focus on RM care. We aimed to explore the experiences of women and men who have received RM care and identify patient-centred care items linked to overall RM care experience. METHODS: Between September and November 2021, we invited people who had experienced two or more consecutive first trimester miscarriages and received care for RM in Ireland in the ten-year period prior to participate in a cross-sectional web-based national survey. The survey was purposefully designed and administered via Qualtrics. It included questions on sociodemographics, pregnancy and pregnancy loss history, investigation and treatment for RM, overall RM care experience, and patient-centred care items at various stages of the RM care pathway such as respect for patients' preferences, information and support, the environment, and involvement of partners/family. We analysed data using Stata. RESULTS: We included 139 participants (97% women, n = 135) in our analysis. Of the 135 women, 79% were aged 35-44 years (n = 106), 24% rated their overall RM care experience as poor (n = 32), 36% said the care they received was much worse than expected (n = 48), and 60% stated health care professionals in different places did not work well together (n = 81). Women were more likely to rate a good care experience if they had a healthcare professional to talk to about their worries/fears for RM investigations (RRR 6.11 [95% CI: 1.41-26.41]), received a treatment plan (n = 70) (RRR 3.71 [95% CI: 1.28-10.71]), and received answers they could understand in a subsequent pregnancy (n = 97) (RRR 8 [95% CI: 0.95-67.13]). CONCLUSIONS: While overall experience of RM care was poor, we identified areas that could potentially improve people's RM care experiences - which have international relevance - such as information provision, supportive care, communication between healthcare professionals and people with RM, and care coordination between healthcare professionals across care settings.

Healthcare professionals' experiences and perceptions of providing support for mental health during the period from pregnancy to two years postpartum.

OBJECTIVE: Mental health issues in the perinatal period are common, and can have negative consequences for maternal and child health. Healthcare professionals (HCPs) who provide women with perinatal care are well-placed to detect mental health issues and provide support. This study therefore examines HCPs' experiences and perceptions of providing mental health support during the perinatal period, including during the COVID-19 pandemic. DESIGN: An exploratory realist qualitative study was conducted. SETTING: Republic of Ireland PARTICIPANTS: A purposive sampling strategy was employed to recruit HCPs (e.g., general practitioners, midwives, public health nurses, practice nurses, doulas, and breastfeeding counsellors), via professional bodies in Ireland. An invitation to participate was also circulated via Twitter. A total of 18 HCPs participated in semi-structured interviews conducted between 18/8/2020 and 24/5/2021. MEASUREMENTS AND FINDINGS: Semi-structured interviews were conducted according to a topic guide designed by a multidisciplinary team. Data were analysed using thematic analysis. Four themes were developed: 'Supporting women in healthcare settings,' 'Skills and capacity to provide adequate care,' 'Structural barriers to care provision,' and 'The impact of the COVID-19 pandemic on stress support.' KEY CONCLUSIONS: HCPs reported providing emotional support and advocacy, but highlighted challenges, including limited capacity to address women's concerns, clinical culture and hierarchy, insufficient organisational investment, and social inequities in support access. Some HCPs felt these barriers could lead to additional psychological harm. HCPs also reported that the pandemic had introduced novel stressors and changed the nature of the mental health support they provided. IMPLICATIONS FOR PRACTICE: Interventions incorporating education and physical resources for HCPs, increased investment in specialist perinatal mental health services, increased investment in holistic supports, and changes to address cultural challenges in care environments, may facilitate - or enhance - support for women.

Effects of maternal stress and/or anxiety interventions in the first 1000 days:Systematic review of reviews.

OBJECTIVE: Effective interventions are needed to mitigate effects of stress and anxiety from conception and up to two years postpartum (the first 1000 days), but it is unclear what works, for what populations and at what time points. This review aimed to synthesise evidence from existing reviews of the effects of stress and anxiety interventions. METHODS: A systematic review of systematic reviews was conducted. PsycINFO, CINAHL, MEDLINE and the Cochrane databases were searched (inception to January 2020). Reviews were eligible if they examined effects of interventions during the first 1000 days on women's stress and/or anxiety. Extracted data were narratively synthesised. Review quality was assessed using existing recommendations including the AMSTAR tool . RESULTS: Thirty-four reviews were eligible for inclusion; 21 demonstrated high methodological quality. Cognitive behavioural therapy demonstrates some beneficial effects for anxiety across the first 1000 days for general and at-risk populations. Support-based interventions demonstrate effects for stress and anxiety for at-risk mothers in the postpartum. Music, yoga and relaxation demonstrate some effects for stress and anxiety, but studies are limited by high risk of bias. CONCLUSION: Existing evidence is inconsistent. Cognitive behavioural therapy and support-based interventions demonstrate some benefits. Further methodologically and conceptually robust research is needed.

Exploring first-time mothers' experiences and knowledge about behavioural risk factors for stillbirth.

BACKGROUND: Modifiable factors such as substance use, lack of attendance at antenatal care, overweight or obesity and sleeping position are associated with a higher risk of stillbirth. This qualitative study aimed to explore women's experiences of modifiable factors during pregnancy and their awareness of stillbirth. METHODS: Purposive sampling was implemented by hospital staff in a large tertiary maternity hospital in Ireland between November 2020 and March 2021. Women were approached during their stay in the hospital and were invited to participate in a semistructured interview 3-5 months later. Eligible women were primiparous, >18 years of age and had an uncomplicated pregnancy and delivery. Eighteen women who consented to be followed up were interviewed at 3-5 months postpartum. Thematic analysis was used to analyse the data. RESULTS: Four themes were identified: attitudes towards behaviour change, awareness regarding stillbirth and risk factors, the silence around stillbirth and risks, and attitudes towards receiving information about stillbirth. Women spoke about behaviour change in terms of outcomes, and most changes (e.g., ceasing alcohol consumption) were perceived as easy to manage. Awareness of stillbirth was limited among the women interviewed, and the association between risk behaviours and stillbirth was not known by any woman. Results suggest that there is a silence around stillbirth, including in antenatal care, which hinders information provision. However, most women highlighted the value of receiving information and extra education about modifiable risk factors and stillbirth. CONCLUSION: There is a general lack of understanding of the link between behavioural risk factors and potential pregnancy outcomes such as stillbirth. Providing further information to women about stillbirth and providing additional support with behaviour change might contribute to enhancing preventive efforts. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in this study by providing their experiences of antenatal care which were used as primary data.

Co-Design of a Reusable Learning Object (RLO) to Address Caregiver Responsive Infant Feeding Behaviours (CRIB) to Prevent Childhood Obesity: A Mixed-Method Protocol.

Responsive infant feeding is a key strategy for childhood obesity prevention. Responsive feeding involves caregivers responding to infant hunger and satiety cues in a timely and developmentally appropriate manner. There is a dearth of evidence-based information and guidance for caregivers on how to responsively feed their infants. The aim of this research is to co-design a Reusable Learning Object (RLO) and guidance infographic to improve caregiver awareness, understanding and use of responsive infant feeding behaviours. The Capability, Opportunity, Motivation and Behaviour (COM-B) model of behaviour change and the Aim, Storyboarding, Populate specification, Implement media, Review and release prototype, and Evaluate (ASPIRE) approach for digital intervention co-design will be utilised. Four co-design workshops with caregivers of infants and healthcare professionals (HCPs) will determine priority RLO content. Content analysis will enable RLO development and process reporting. Formative and summative surveys will be conducted to evaluate the usability of the RLO, its impact on caregivers and its potential implementation into NHS care pathways. The output will be a RLO on responsive feeding for caregivers and an infographic for HCPs/support workers which will contribute to a future obesity prevention intervention. The findings will be disseminated to stakeholders and submitted for publication in a peer-reviewed journal.

Nurturing children's development through healthy eating and active living: Time for policies to support effective interventions in the context of responsive emotional support and early learning.

Fostering the growth, development, health, and wellbeing of children is a global priority. The early childhood period presents a critical window to influence lifelong trajectories, however urgent multisectoral action is needed to ensure that families are adequately supported to nurture their children's growth and development. With a shared vision to give every child the best start in life, thus helping them reach their full developmental potential, we have formed the International Healthy Eating Active Living Matters (HEALing Matters) Alliance. Together, we form a global network of academics and practitioners working across child health and development, and who are dedicated to improving health equity for children and their families. Our goal is to ensure that all families are free from structural inequality and oppression and are empowered to nurture their children's growth and development through healthy eating and physical activity within the context of responsive emotional support, safety and security, and opportunities for early learning. To date, there have been disparate approaches to promoting these objectives across the health, community service, and education sectors. The crucial importance of our collective work is to bring these priorities for early childhood together through multisectoral interventions, and in so doing tackle head on siloed approaches. In this Policy paper, we draw upon extensive research and call for collective action to promote equity and foster positive developmental trajectories for all children. We call for the delivery of evidence-based programs, policies, and services that are co-designed to meet the needs of all children and families and address structural and systemic inequalities. Moving beyond the "what" is needed to foster the best start to life for all children, we provide recommendations of "how" we can do this. Such collective impact will facilitate intergenerational progression that builds human capital in future generations.

How we define recurrent miscarriage matters: A qualitative exploration of the views of people with professional or lived experience.

BACKGROUND: Recurrent miscarriage (RM) affects 1%-3% of women/couples of reproductive age depending on the definition used, for example, whether 2 or ≥3 miscarriages. Stakeholders' views of how RM is defined have received limited attention to date. A definition reflects the medical evidence and values of a society at the time, and thus warrants ongoing review. AIM: We aimed to explore the views of women and men with lived experience of RM, and those involved in the delivery/management of services and supports, on how RM is and/or should be defined. METHODS: We adopted a qualitative study design, incorporating semi-structured interviews. We used purposive sampling to recruit participants in the Republic of Ireland, ensuring diverse perspectives were included. Women and men with lived experience of ≥2 consecutive first-trimester miscarriages were recruited via health professionals and social media; other participants via the research team's networks. Interviews were audio-recorded, transcribed, pseudo-anonymized and analysed using reflexive thematic analysis. FINDINGS: We conducted interviews with 42 health professionals/service providers and 13 women and 7 men with lived experience of RM (June 2020 to February 2021). We generated three interrelated themes from the data: (i) The need for a standardized definition of recurrent miscarriage-Finding a balance between research evidence, individual needs and healthcare resources, (ii) The definition is a route to finding an answer and/or validating women/couples' experience of loss and (iii) Working around the definition-Advocacy and impacts. CONCLUSION: A nuanced approach to defining RM is warranted, one which is evidence-informed recognizes the individual needs of women/couples, and considers healthcare resources. PATIENT OR PUBLIC CONTRIBUTION: Members of the multidisciplinary RE:CURRENT (REcurrent miscarriage: evaluating CURRENT services) Project Research Advisory Group (including four parent advocates, two of whom are co-authors on this article) were actively involved throughout the study, including the generation of topic guides and the refining of themes.

Facilitators and barriers influencing weight management behaviours during pregnancy: a meta-synthesis of qualitative research.

BACKGROUND: Obesity and overweight are considered risk factors for a range of adverse outcomes, including stillbirth. This study aims to identify factors reported by women influencing weight management behaviours during pregnancy. METHODS: A systematic search was conducted in five databases from inception to 2019 and updated in 2021. Qualitative studies involving pregnant or post-partum women, from high-income countries, examining women's experiences of weight management during pregnancy were included. Meta-ethnography was used to facilitate the meta-synthesis of 17 studies. RESULTS: Three themes were identified during the analysis: (1) Awareness and beliefs about weight gain and weight management, which included level of awareness and knowledge about dietary and exercise recommendations, risk perception and decision balance, perceived control over health and weight gain and personal insecurities. (2) Antenatal healthcare, women's experiences of their interactions with healthcare professionals during the antenatal period and the quality of the education received had an effect on women's behaviour. Further, our findings highlight the need for clear and direct information, and improved interactions with healthcare professionals, to better support women's weight management behaviours. (3) Social and environmental influence, the social judgement and stigmatization associated with overweight and obesity also acted as a negative influence in womens' engagement in weight management behaviours. CONCLUSION: Interventions developed to promote and maintain weight management behaviours during pregnancy should consider all levels of influence over women's behaviours, including women's level of awareness and beliefs, experiences in antenatal care, education provision and social influence.

Core outcome set for early intervention trials to prevent obesity in childhood (COS-EPOCH): Agreement on "what" to measure.

BACKGROUND: Heterogeneity in the outcomes collected and reported in trials of interventions to prevent obesity in the first five years of life highlights the need for a core outcome set to streamline intervention evaluation and synthesis of effects. This study aimed to develop a core outcome set for use in early childhood obesity prevention intervention studies in children from birth to five years of age (COS-EPOCH). METHODS: The development of the core outcome set followed published guidelines and consisted of three stages: (1) systematic scoping review of outcomes collected and reported in early childhood obesity prevention trials; (2) e-Delphi study with stakeholders to prioritise outcomes; (3) meeting with stakeholders to reach consensus on outcomes. Stakeholders included parents/caregivers of children aged ≤ five years, policy-makers/funders, researchers, health professionals, and community and organisational stakeholders interested in obesity prevention interventions. RESULTS: Twenty-two outcomes from nine outcome domains (anthropometry, dietary intake, sedentary behaviour, physical activity, sleep, outcomes in parents/caregivers, environmental, emotional/cognitive functioning, economics) were included in the core outcome set: infant tummy time; child diet quality, dietary intake, fruit and vegetable intake, non-core food intake, non-core beverage intake, meal patterns, weight-based anthropometry, screentime, time spent sedentary, physical activity, sleep duration, wellbeing; parent/caregiver physical activity, sleep and nutrition parenting practices; food environment, sedentary behaviour or physical activity home environment, family meal environment, early childhood education and care environment, household food security; economic evaluation. CONCLUSIONS: The systematic stakeholder-informed study identified the minimum outcomes recommended for collection and reporting in early childhood obesity prevention trials. Future work will investigate the recommended instruments to measure each of these outcomes. The core outcome set will standardise guidance on the measurement and reporting of outcomes from early childhood obesity prevention interventions, to better facilitate evidence comparison and synthesis, and maximise the value of data collected across studies.