Early-onset fetal growth restriction:A systematic review on mortality and morbidity

Introduction: Severe early-onset fetal growth restriction is an obstetric condition with significant risks of perinatal mortality, major and minor neonatal morbidity, and long-term health sequelae. The prognosis of a fetus is influenced by the extent of prematurity and fetal weight. Clinical care is individually adjusted. In literature, survival rates vary and studies often only include live-born neonates with missing rates of antenatal death. This systematic review aims to summarize the literature on mortality and morbidity. Material and methods: A broad literature search was conducted in OVID MEDLINE from 2000 to 26 April 2019 to identify studies on fetal growth restriction and perinatal death. Studies were excluded when all included children were born before 2000 because (neonatal) health care has considerably improved since this period. Studies were included that described fetal growth restriction diagnosed before 32 weeks of gestation and antenatal mortality and neonatal mortality and/or morbidity as outcome. Quality of evidence was rated with the GRADE instrument. Results: Of the 2604 publications identified, 25 studies, reporting 2895 pregnancies, were included in the systematic review. Overall risk of bias in most studies was judged as low. The quality of evidence was generally rated as very low to moderate, except for 3 large well-designed randomized controlled trials. When combining all data on mortality, in 355 of 2895 pregnancies (12%) the fetus died antenatally, 192 died in the neonatal period (8% of live-born neonates) and 2347 (81% of all pregnancies) children survived. Of the neonatal morbidities recorded, respiratory distress syndrome (34% of the live-born neonates), retinopathy of prematurity (13%) and sepsis (30%) were most common. Of 476 children that underwent neurodevelopmental assessment, 58 (12% of surviving children, 9% of all pregnancies) suffered from cognitive impairment and/or cerebral palsy. Conclusions: When combining the data of 25 included studies, survival in fetal growth restriction pregnancies, diagnosed before 32 weeks of gestation, was 81%. Neurodevelopmental impairment was assessed in a minority of surviving children. Individual prognostic counseling on the basis of these results is hampered by differences in patient and pregnancy characteristics within the included patient groups

Developing a realist informed framework for cultural adaptation of lifestyle interventions for the prevention of type 2 diabetes in South Asian populations in Europe

Aims Selected lifestyle interventions proven effective for White-European populations have been culturally adapted for South Asian populations living in Europe, who are at higher risk of type 2 diabetes. However, a limited theoretical basis underpins how cultural adaptations are believed to augment intervention effectiveness. We undertook a realist review to synthesise existing literature on culturally adapted type 2 diabetes prevention interventions, to develop a framework that shows ‘how’ cultural adaptation works, for ‘whom’ and in ‘what contexts’. Methods We followed the stepped methodological approach of realist review. Our work concluded a European-wide project (EuroDHYAN), and core studies were identified from the preceding EuroDHYAN reviews. Data were extracted, coded into themes and synthesised to create ‘Context–Mechanism–Outcome’ configurations and to generate a refined explanatory framework. Results We identified eight core intervention papers. From this evidence, and supporting literature, we examined the ‘Team’ domain of cultural adaptation and identified a mechanism of shared cultural identity which we theorised as contributing to strong team-participant relationships. We also identified four key contexts which influenced intervention outcomes: ‘research setting’ and ‘heterogeneous populations’ (intrinsic to the intervention) and ‘broader environment’ and ‘socio-cultural stress’ (extrinsic barriers). Conclusions This work instigates research into the mechanisms of cultural adaptation which, if pursued, will allow a more nuanced understanding of how to apply adaptations, and for whom. In practice we recommend greater consideration of heterogeneous and intersecting population characteristics; how intervention design can safeguard sustainability; and how the four key contexts identified influence how, and whether, these interventions work

The acceptability and effect of a culturally-tailored dance intervention to promote physical activity in women of South Asian origin at risk of diabetes in the Netherlands—A mixed-methods feasibility study

OBJECTIVE: Populations of South Asian (SA) origin are at high risk of type 2 diabetes (T2D) and related complications. Analysis of T2D prevention interventions for these populations show that limited attention has been given to facilitating increased physical activity (PA) in a culturally appropriate manner. The aim of this feasibility study was to identify whether culturally tailored dance is acceptable to women of SA origin, and whether it may have an effect on PA and PA-related social cognitive determinants. METHODS: A community-based culturally tailored dance intervention choreographed to Bollywood music was evaluated among 26 women of SA origin in the Netherlands for 10 weeks, 2 times per week. This feasibility study was conducted as a before-after, mixed-methods study, combining data from focus groups, individual interviews, questionnaires and accelerometers. RESULTS: The majority of participants were in the age of 50–59 years and at moderate-to-high T2D risk. There was high attendance (73%), low drop out (12%) and high satisfaction scores for various program components. Key reasons for participation were the cultural appropriateness, in particular the combination of historically and emotionally embedded Indian music and dance, and the non-competitive nature of the intervention. On average, in each of the 19 one-hour sessions, participants spent 30.8 minutes in objectively assessed light intensity PA, 14.1 minutes in moderate intensity PA and 0.3 minutes in vigorous PA, and took 2,100 steps during a session. At follow-up, total moderate-to-vigorous PA increased by 7.8 minutes per day (95%CI: 3.1, 12.5) and daily steps increased by 784 (95%CI: 173, 1394), with a concomitant reduction in light PA of 12 minutes per day (95%CI: -21.9, -2.2). Positive shifts in some PA-behavioral social cognitive determinants and no negative side-effects were observed. CONCLUSIONS: Bollywood Dance appears to be a feasible, culturally acceptable and potentially effective approach to increase PA in SA women in the Netherlands. A pilot cluster RCT is needed to confirm these initial findings on effectiveness

A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study.

BACKGROUND: Fetal growth restriction refers to a fetus that does not reach its genetically predetermined growth potential. It is well-recognized that growth-restricted fetuses are at increased risk of both short- and long-term adverse outcomes. Systematic evaluation of the evidence from clinical trials of fetal growth restriction is often difficult because of variation in the outcomes that are measured and reported. The development of core outcome sets for fetal growth restriction studies would enable future trials to measure similar meaningful outcomes. OBJECTIVE: The purpose of this study was to develop core outcome sets for trials of prevention or treatment of fetal growth restriction. STUDY DESIGN: This was a Delphi consensus study. A comprehensive literature review was conducted to identify outcomes that were reported in studies of prevention or treatment of fetal growth restriction. All outcomes were presented for prioritization to key stakeholders (135 healthcare providers, 68 researchers/academics, and 35 members of the public) in 3 rounds of online Delphi surveys. A priori consensus criteria were used to reach agreement on the final outcomes for inclusion in the core outcome set at a face-to-face meeting with 5 healthcare providers, 5 researchers/academics, and 6 maternity service users. RESULTS: In total, 22 outcomes were included in the final core outcome set. These outcomes were grouped under 4 domains: maternal (n=4), fetal (n=1), neonatal (n=12), and childhood (n=5). CONCLUSION: The Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints study identified a large number of potentially relevant outcomes and then reached consensus on those factors that, as a minimum, should be measured and reported in all future trials of prevention or treatment of fetal growth restriction. This will enable future trials to measure similar meaningful outcomes and to ensure that findings from different studies can be compared and combined

Dietary and physical activity recommendations to prevent type 2 diabetes in South Asian adults:A systematic review

Intervention trials and guidelines for the prevention of type 2 diabetes (T2D) in populations of South Asian origin often include strategies to improve diet and physical activity that are based on those developed for other populations. These may be suboptimal for the South Asian target populations. We aimed to provide an overview of included recommended dietary and physical activity components, and to identify whether these were supported by evidence of their effectiveness. Databases were searched until September 2017 for intervention studies and guidelines with an adult South Asian population without T2D. The protocol was registered in PROSPERO, registration number: CRD42015207067. The quality of included studies and guidelines was assessed. Dietary and physical activity components, and effects on T2D incidence, glycemic status and adiposity measures, were summarized in tabular format and evaluated narratively. Eighteen intervention studies and four guidelines were identified. Dietary and physical activity components were similar to recommendations for the general population. Intervention studies and guidelines did not reference evidence to support the effectiveness of components included in the intervention for South Asian populations in particular. Moreover, we were unable to assess patterns of components to determine the effects of specific components. Evaluation of current and emerging components among South Asian populations and subgroups seems necessary to formulate more specific recommendations in future intervention studies and guidelines

Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE).

BACKGROUND: Foetal growth restriction (FGR) refers to a foetus that does not reach its genetically predetermined growth potential. It is well recognised that growth-restricted foetuses are at increased risk of stillbirth, foetal compromise, early neonatal death and neonatal morbidity. Later in life, they are prone to health problems, including increased risk of cardiovascular diseases and neurodevelopmental disorders. Interventions for preventing and treating FGR have been studied in many trials, but evidence is often difficult to synthesise and compare because of differences in the selection and definition of outcomes. To enable future trials to measure similar, meaningful outcomes, we are developing two core outcome sets (COS) - one for prevention and the other for treatment of FGR. METHODS: We will review the literature to identify previously reported outcomes. An international panel of relevant stakeholders who have experience of FGR (parent or carer of a baby that was growth restricted, health professional involved in the care of mothers and babies affected by FGR, a person with expertise in FGR research) will rate the importance of each of those outcomes in a series of three sequential online rounds of a Delphi study. Participants will be able to add items to the proposed list in round 1. A final face-to-face consensus meeting will be held with representatives of each stakeholder group at which a final list of outcomes for inclusion in the COS will be agreed. DISCUSSION: The development of COSs in FGR will ensure the collection and reporting of a minimum dataset agreed by stakeholder consensus and will reduce inconsistencies in the reporting of outcomes across relevant trials. Such standardisation in the reporting of outcomes will improve synthesis of evidence and generalisability of knowledge in the future by reducing heterogeneity in outcomes between trials and thus improve the results of systematic reviews and meta-analyses. Ultimately, we hope that the COSs will lead to an improvement in the quality of evidence-based clinical practice, enhance patient care, and improve the quality and consistency of research. TRIAL REGISTRATION: Not applicable. This study is registered in the Core Outcome Measures for Effectiveness (COMET) database

Developing a realist informed framework for cultural adaptation of lifestyle interventions for the prevention of type 2 diabetes in South Asian populations in Europe

Aims Selected lifestyle interventions proven effective for White-European populations have been culturally adapted for South Asian populations living in Europe, who are at higher risk of type 2 diabetes. However, a limited theoretical basis underpins how cultural adaptations are believed to augment intervention effectiveness. We undertook a realist review to synthesise existing literature on culturally adapted type 2 diabetes prevention interventions, to develop a framework that shows ‘how’ cultural adaptation works, for ‘whom’ and in ‘what contexts’. Methods We followed the stepped methodological approach of realist review. Our work concluded a European-wide project (EuroDHYAN), and core studies were identified from the preceding EuroDHYAN reviews. Data were extracted, coded into themes and synthesised to create ‘Context–Mechanism–Outcome’ configurations and to generate a refined explanatory framework. Results We identified eight core intervention papers. From this evidence, and supporting literature, we examined the ‘Team’ domain of cultural adaptation and identified a mechanism of shared cultural identity which we theorised as contributing to strong team-participant relationships. We also identified four key contexts which influenced intervention outcomes: ‘research setting’ and ‘heterogeneous populations’ (intrinsic to the intervention) and ‘broader environment’ and ‘socio-cultural stress’ (extrinsic barriers). Conclusions This work instigates research into the mechanisms of cultural adaptation which, if pursued, will allow a more nuanced understanding of how to apply adaptations, and for whom. In practice we recommend greater consideration of heterogeneous and intersecting population characteristics; how intervention design can safeguard sustainability; and how the four key contexts identified influence how, and whether, these interventions work

Consensus Based Definition of Growth Restriction in the Newborn

Objective: To develop a consensus definition of growth restriction in the newborn that can be used clinically to identify newborn infants at risk and in research to harmonize reporting and definition in the current absence of a gold standard. Study design: An international panel of pediatric leaders in the field of neonatal growth were invited to participate in an electronic Delphi procedure using standardized methods and predefined consensus rules. Responses were fed back at group-level and the list of participants was provided. Nonresponders were excluded from subsequent rounds. In the first round, variables were scored on a 5-point Likert scale; in subsequent rounds, inclusion of variables and cut-offs were determined with a 70% level of agreement. In the final round participants selected the ultimate algorithm. Results: In total, 57 experts participated in the first round; 79% completed the procedure. Consensus was reached on the following definition: birth weight less than the third percentile, or 3 out of the following: birth weight <10th percentile; head circumference <10th percentile; length <10th percentile; prenatal diagnosis of fetal growth restriction; and maternal pregnancy information. Conclusions: Consensus was reached on a definition for growth restriction in the newborn. This definition recognizes that infants with birth weights <10th percentile may not be growth restricted and that infants with birth weights >10th percentile can be growth restricted. This definition can be adopted in clinical practice and in clinical trials to better focus on newborns at risk, and is complementary to the previously determined definition of fetal growth restriction

A culturally adapted diet and physical activity text message intervention to prevent Type 2 diabetes mellitus for women of Pakistani origin living in Scotland: formative study

Background: Individuals of South Asian origin are at an increased risk of developing type 2 diabetes mellitus (T2DM) compared with other ethnic minority groups. Therefore, there is a need to develop interventions to address, and reduce, this heightened risk. Objective: We undertook formative work to develop a culturally adapted diet and physical activity text message intervention to prevent T2DM for women of Pakistani origin living in Scotland. Methods: We used a stepwise approach that was informed by the Six Steps in Quality Intervention Development framework, which consisted of gathering evidence through literature review and focus groups (step 1), developing a program theory for the intervention (step 2), and finally developing the content of the text messages and an accompanying delivery plan (step 3). Results: In step 1, we reviewed 12 articles and identified 3 key themes describing factors impacting on diet and physical activity in the context of T2DM prevention: knowledge on ways to prevent T2DM through diet and physical activity; cultural, social, and gender norms; and perceived level of control and sense of inevitability over developing T2DM. The key themes that emerged from the 3 focus groups with a total of 25 women were the need for interventions to provide “friendly encouragement,” “companionship,” and a “focus on the individual” and also for the text messages to “set achievable goals” and include “information on cooking healthy meals.” We combined the findings of the focus groups and literature review to create 13 guiding principles for culturally adapting the text messages. In step 2, we developed a program theory, which specified the main determinants of change that our text messages should aim to enhance: knowledge and skills, sense of control, goal setting and planning behavior, peer support, and norms and beliefs guiding behavior. In step 3, we used both the intervention program theory and guiding principles to develop a set of 73 text messages aimed at supporting a healthy diet and 65 text messages supporting increasing physical activity. Conclusions: We present a theory-based approach to develop a culturally adapted diet and physical activity text message intervention to prevent T2DM for women of Pakistani origin living in Scotland. This study outlines an approach that may also be applicable to the development of interventions for other ethnic minority populations in diverse settings. There is now a need to build on this formative work and undertake a feasibility trial of a text message–based diet and physical activity intervention to prevent T2DM for women of Pakistani origin living in Scotland