Impact of antenatal glucocorticoid exposure on the activity of the stress system, cognition and behavior in 8 to 9-year-old children: a clinical cohort study

Objective: To determine stress-sensitivity and neurodevelopmental outcome in 8- to 9-year-old children following antenatal exposure to glucocorticoid (GC) prophylaxis for neonatal respiratory distress syndrome. Design: Clinical cohort study. Setting: University-based obstetric clinic in Central Germany. Population: 31 term or near-term born children whose mothers received single or multiple courses of betamethasone (BM) to induce fetal lung maturation in threatened preterm birth compared to 39 non-exposed children. Methods: Multi-system assessment of the individual stress response together with an analysis of cognitive, behavioral and electrocortical functioning. Main Outcome Measures: Activity of the hypothalamus-pituitary-adrenal axis (HPAA, primary outcome domain) and the autonomic nervous system (ANS, secondary outcome domain) including markers of heart rate variability (HRV). Additional endpoints were the cognitive performance (IQ) and attention-deficit/hyperactivity disorder (ADHD) core symptoms. Results: HPAA activity was not affected by antenatal GC-exposure. ANS activity in GC-exposed children shifted towards a higher parasympathetic tone reflected by a higher overall high-frequency band power of HRV (1313 vs. 762 msec2/Hz, p=0.03). BM-exposed children had lower cognitive performance (IQ 96.9 vs. 108.0, p<0.01) and a marginally higher ADHD score (FBB-ADHD scale 5.5 vs. 4.6 points, p=0.04). A monotonic dose-response relationship between GC-exposure and stress-induced activity of the ANS and IQ was estimated post-hoc. Conclusions: Antenatal exposure to supraphysiological concentrations of BM in the context of threatened preterm birth was associated with multidimensional changes in stress-sensitivity and neurodevelopment in later life. As these changes may be dose-dependent, antenatal GC prophylaxis should be used at the minimum effective dose after a careful risk-benefit assessment.

A Longitudinal Systematic Review of Credit Risk Assessment and Credit Default Predictors

This study aims to reveal the predictors of individuals’ financial behavior associated with credit default for accurate and reliable credit risk assessment. Within the scope of credit use research, a systematic review of 108 studies was performed. Among the reviewed studies, a fair number have analyzed the determinants of default and delinquency. A remarkable number has examined the factors affecting outstanding and problematic debt levels, and some have investigated the financial behavior in terms of responsibility, debt repayment, and credit misuse. A wide range of socioeconomic, demographic, psychological, situational, and behavioral factors was explored, and their role in predicting the investigated outcome domain at various time-points was analyzed. The main analysis techniques and mix of predictors in papers also differed based on different time periods. While the synthesis of findings revealed some strong and consistent predictors for each outcome variable, mixed results were obtained for some factors. Additionally, a cluster of new practices that includes a wide range of alternative factors to improve prediction accuracies were uncovered. Study findings revealed a paradigm shift regarding the use of non-traditional data sources, especially big data, and novel techniques.

558 Summarising the Reporting of Outcomes in Studies of Robot Assisted Cholecystectomy: A Systematic Review

Background Robot-assisted cholecystectomy (RC) has seen increasing adoption into clinical practice despite a lack of evidence to demonstrate superiority over conventional methods. Consistency in outcome selection, definition and reporting between studies is required for effective evidence synthesis and to minimise research waste. The aim of this study was to conduct an in-depth analysis of the outcomes reported in studies of RC. This work will inform the need for a core outcome set (COS). Method Systematic searches identified all published studies reporting RC, from inception to February 2020. Outcomes reported in each manuscript were recorded verbatim and categorised into domains. All outcomes were coded in duplicate. Where reported, the follow up period of each study was documented. Results Of 1425 abstracts screened, ninety studies met the criteria for inclusion. A total of 878 outcomes were reported. Each study included a median of 8 outcomes (range 3-26). Outcome selection was heterogeneous, with those relating to technical/operative factors (n = 383, 88 studies), complications (n = 245, 81 studies) and health economics (n = 139, 72 studies) used most frequently. No single outcome, or outcome domain, was reported in all studies. Only 30 studies reported a follow-up period, which ranged from 14 days to 46 months. In thirteen, the follow-up was for less than or equal to one month. Conclusions We identified significant heterogeneity in the selection and reporting of outcomes in studies of RC and support calls for standardisation and development of a COS.

1158 Summarising the Reporting of Study Outcomes in Robotic Oesophagectomy: A Systematic Review

Introduction There is an increasing adoption of robotic oesophagectomy in place of standard techniques for oesophageal cancer resection. This is potentially due to its perceived technical benefits and improved short-term outcomes. Consistency in outcome selection, definition and reporting between studies is required for effective evidence synthesis and prevention of research waste. The aim of this review is to perform an in-depth analysis of outcome reporting in robotic oesophagectomy. Method Systematic searches were conducted using key words for robotic surgery and oesophageal cancer, from inception to February 2020. Studies reporting any outcome for robotic oesophagectomy were included. Outcomes in each study were recorded verbatim and categorised into twelve domains. Outcomes were independently categorised by two reviewers. Where reported, the follow-up period was also recorded. Results Of 954 abstracts screened, 226 full texts were reviewed and 102 included. Only one study was a RCT. A total of 1422 outcomes were reported. Each study had a median of 14 reported outcomes (range 1-25). Outcomes related to complications (n = 578, 99 studies), technical/operative factors (n = 290, 90 studies), and pathology (e.g., resection margin) (n = 197, 83 studies) were reported most frequently. No single outcome, or outcome domain was reported in all studies. No studies used a core outcome set for reporting. Forty-five studies stated a follow-up period, ranging from &lt;1 month to 58 months. Conclusions There is significant heterogeneity in the selection and reporting of outcomes in robotic oesophagectomy. This calls for the use of a core outcome set to allow standardisation and transparency of outcome reporting.

EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis

BackgroundClinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses.ObjectivesTo develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain.MethodsThe EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously.ResultsTwo overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1–3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5–7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9).ConclusionAdherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.

Considerations for Evidence Frameworks in Education Research

In this chapter, we describe and compare the standards for evidence used by three entities that review studies of education interventions: Blueprints for Healthy Youth Development, Social Programs that Work, and the What Works Clearinghouse. Based on direct comparisons of the evidence frameworks, we identify key differences in the level at which effectiveness ratings are granted (i.e., intervention vs. outcome domain), as well as in how each entity prioritizes intervention documentation, researcher independence, and sustained versus immediate effects. Because such differences in priorities may result in contradictory intervention ratings between entities, we offer a number of recommendations for a common set of standards that would harmonize effectiveness ratings across the three entities while preserving differences that allow for variation in user priorities. These include disentangling study rigor from intervention effectiveness, ceasing vote counting procedures, adding replication criteria, adding fidelity criteria, assessing baseline equivalence for randomized studies, making quasi-experiments eligible for review, adding criteria for researcher independence, and providing effectiveness ratings at the level of the outcome domain rather than the intervention.

Methodological aspects of design, analysis and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis: results of two systematic literature reviews informing EULAR points to consider

ObjectiveTo summarise the methodological aspects in studies with work participation (WP) as outcome domain in inflammatory arthritis (IA) and other chronic diseases.MethodsTwo systematic literature reviews (SLRs) were conducted in key electronic databases (2014–2019): search 1 focused on longitudinal prospective studies in IA and search 2 on SLRs in other chronic diseases. Two reviewers independently identified eligible studies and extracted data covering pre-defined methodological areas.ResultsIn total, 58 studies in IA (22 randomised controlled trials, 36 longitudinal observational studies) and 24 SLRs in other chronic diseases were included. WP was the primary outcome in 26/58 (45%) studies. The methodological aspects least accounted for in IA studies were as follows (proportions of studies positively adhering to the topic are shown): aligning the studied population (16/58 (28%)) and sample size calculation (8/58 (14%)) with the work-related study objective; attribution of WP to overall health (28/58 (48%)); accounting for skewness of presenteeism/sick leave (10/52 (19%)); accounting for work-related contextual factors (25/58 (43%)); reporting attrition and its reasons (1/58 (2%)); reporting both aggregated results and proportions of individuals reaching predefined meaningful change or state (11/58 (16%)). SLRs in other chronic diseases confirmed heterogeneity and methodological flaws identified in IA studies without identifying new issues.ConclusionHigh methodological heterogeneity was observed in studies with WP as outcome domain. Consensus around various methodological aspects specific to WP studies is needed to improve quality of future studies. This review informs the EULAR Points to Consider for conducting and reporting studies with WP as an outcome in IA.

AB1177 METHODOLOGICAL ASPECTS OF DESIGN, ANALYSES AND REPORTING OF STUDIES WITH WORK PARTICIPATION AS OUTCOME DOMAIN IN PATIENTS WITH INFLAMMATORY ARTHRITIS: RESULTS OF TWO SYSTEMATIC LITERATURE REVIEWS INFORMING EULAR POINTS TO CONSIDER

Background:Inflammatory arthritis (IA) has substantial impact on work participation (WP). However, methodological issues hamper interpretation, comparison and meta-analyses of studies with WP as outcome domain. Sources of heterogeneity and methodological choices should be assessed in order to improve the quality of future studies.Objectives:To summarize methodological choices in studies with WP as outcome domain in IA and other chronic diseases.Methods:A EULAR task force on ‘points to consider (PtC) when designing, analysing and reporting studies with WP as outcome domain among patients with IA’ outlined the scope of the systematic literature review (SLR) and identified 6 areas of potential concern (Table 1). Two searches were conducted (Figure 1): Search 1 (S1): original studies in IA (RCTs and longitudinal prospective observational studies); S2: systematic reviews in other chronic diseases. Two reviewers independently identified eligible studies and extracted data for the pre-defined methodological areas.Table 1.Methodological issues across the 6 pre-defined areas (search 1, n=62)AreaMethodological issues*1. Study design- 16/62 (26%) and 8/62 (13%) studies aligned the target population and sample size with the study’s work outcome.- 9/39 (24%) of the interventional studies aimed to assess changes of work status (employment/disability) over a very short follow-up time (≤6 months).2. Work outcome domains- 7/33 (21%) of studiesdefined work status.- 30/30 (100%), 38/38 (100%) and 7/7 (100%)defined absenteeism, presenteeism and unpaid work, respectively.3. Work outcome measurement instruments- 22/62 (35%) studies usednon-validated instruments(e.g. self-reported days of sick leave/impact of disease on productivity, n=16/62, 26%).4. Contextual factors- 54/62 (87%) studies neglected work-related contextual factors.5. Data analysesOf the studies measuring absenteeism and/or presenteeism:- 10/38 (26%) accounted forskewnessof the work outcome.- 30/38 (79%) tookinterdependencebetween outcomes as part of work productivity and activity impairment questionnaire into account.6. Reporting- 62/62 (100%) studies reported the size and characteristics of the (sub)groups in which the analyses were performed.- 1/62 (2%) reported loss to follow-up and work-related reasons for drop-out.- 42/62 (68%) studies presentedaggregatedresults; 11/62 (18%) presented results aspercentages according to meaningful thresholds; 9/62 (14%): both forms.- 21/24 (88%) studies reportingproductivity costs,provided data on natural volumes (days/hours) used to calculate costs.*The number of studies in denominators vary by methodological issue.Results:We included 62 original studies in IA (23 RCTs, 16 interventional and 23 non-interventional observational studies) and 28 SLRs in other chronic diseases. The methodological aspects most often neglected in original studies (Table 1) were: the choice of the study design in relation to the work-related study objective; definitions of the WP outcome domains considered; accounting for skewness of the work outcome; consideration of work-related contextual factors; reporting attrition and its reasons and reporting both aggregated results as well as proportions of individuals based on predefined meaningful thresholds. SLRs on other chronic diseases confirmed high heterogeneity and methodological flaws in all the 6 key methodological areas without identifying new problematic areas.Conclusion:High methodological heterogeneity was observed in studies with WP. Consensus around the key methodological aspects is needed to homogenise and improve the quality of future studies. This review informs the EULAR PtC for the conduction and reporting of studies with WP as an outcome domain in IA.Disclosure of Interests:Alessia Alunno: None declared, Mary Lucy Marques: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), L. Falzon: None declared, Sofia Ramiro Grant/research support from: MSD, Consultant of: Abbvie, Lilly, Novartis, Sanofi Genzyme, Speakers bureau: Lilly, MSD, Novartis, Polina Putrik: None declared