Standardization in fetal growth restriction:Progression by consensus

For the development of study protocols, data analysis and comparisons of cohorts, and through this to determine the best fitting treatment for a patient, there has to be agreement on the basic principles of the condition concerned. This starts with consensus on the definition. Regarding fetal growth restriction, this consensus was missing. Fetal growth restriction is a frequently studied condition because of the major impact on perinatal morbidity and mortality. The diversity in currently used definitions was described in a systematic review, with 44 different definitions found in 2014. This heterogeneity makes it impossible to compare the results of these studies.Expert consensus is the method of choice, in lack of a gold standard and when empirical evidence is impossible to obtain. A Delphi procedure is a systematic, interactive, group-communication process, to reach consensus in an expert panel. The existing consensus-methodology itself is also founded with little evidence and mainly based on expert-consensus.This thesis aimed to develop consensus on the topic of fetal growth restriction. We succeeded in developing a consensus definition for fetal growth restriction diagnosed in singleton pregnancy (separate for early- and late-onset), in twin pregnancy (separate for monochorionic and dichorionic), the stillborn and the neonate. Additionally, some of the consensus methodology was tested to provide underlying evidence

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

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

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

Effects of dietary and physical activity interventions on the risk of type 2 diabetes in South Asians: meta-analysis of individual participant data from randomised controlled trials

Aims/hypothesis: Individuals of South Asian origin have a high risk of type 2 diabetes and of dying from a diabetes-attributable cause. Lifestyle modification intervention trials to prevent type 2 diabetes in high-risk South Asian adults have suggested more modest effects than in European-origin populations. The strength of the evidence of individual studies is limited, however. We performed an individual participant data meta-analysis of available RCTs to assess the effectiveness of lifestyle modification in South Asian populations worldwide. Methods: We searched PubMed, EMBASE, Cochrane Library and Web of Science (to 24 September 2018) for RCTs on lifestyle modification interventions incorporating diet and/or physical activity in South Asian adults. Reviewers identified eligible studies and assessed the quality of the evidence. We obtained individual participant data on 1816 participants from all six eligible trials (four from Europe and two from India). We generated HR estimates for incident diabetes (primary outcome) and mean differences for fasting glucose, 2 h glucose, weight and waist circumference (secondary outcomes) using mixed-effect meta-analysis overall and by pre-specified subgroups. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to rate the quality of evidence of the estimates. The study is registered with the International Prospective Register of Systematic Reviews ([PROSPERO] CRD42017078003). Results: Incident diabetes was observed in 12.6% of participants in the intervention groups and in 20.0% of participants in the control groups. The pooled HR for diabetes incidence was 0.65 (95% CI 0.51, 0.81; I2 = 0%) in intervention compared with control groups. The absolute risk reduction was 7.4% (95% CI 4.0, 10.2), with no interactions for the pre-specified subgroups (sex, BMI, age, study duration and region where studies were performed). The quality of evidence was rated as moderate. Mean difference for lifestyle modification vs control groups for 2 h glucose was −0.34 mmol/l (95% CI −0.62, −0.07; I2 = 50%); for weight −0.75 kg (95% CI −1.34, −0.17; I2 = 71%) and for waist −1.16 cm (95% CI −2.16, −0.16; I2 = 75%). No effect was found for fasting glucose. Findings were similar across subgroups, except for weight for European vs Indian studies (−1.10 kg vs −0.08 kg, p = 0.02 for interaction). Conclusions/interpretation: Despite modest changes for adiposity, lifestyle modification interventions in high-risk South Asian populations resulted in a clinically important 35% relative reduction in diabetes incidence, consistent across subgroups. If implemented on a large scale, lifestyle modification interventions in high-risk South Asian populations in Europe would reduce the incidence of diabetes in these populations

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

Building consensus and standards in fetal growth restriction studies

Fetal growth restriction is a pathologic condition in which the fetus fails to reach its biologically based growth potential. There is inconsistency in terminology, definition, monitoring, and management, both in clinical practice and in the existing literature. This hampers interpretation and comparison of cohorts and studies. Standardization is essential. With the lack of a golden standard, or the opportunity to come to empirical evidence, consensus procedures can help to establish standardization. Consensus procedures provide no new information but formulate an agreement (as second best in the absence of robust evidence) for clinical and/or research practice on the basis of existing data. Consensus agreements need to be updated when new evidence becomes available and can change over time. In this chapter, we address the different issues that lack uniformity in FGR studies and management. Furthermore, we discuss several consensus methods and recent consensus procedures regarding fetal growth restriction