BackgroundIn 2010 a Cochrane review confirmed that folic acid (FA) supplementation prevents the first- and second-time occurrence of neural tube defects (NTDs). At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all congenital malformations (CMs) or the risk of a specific and selected group of them, namely cardiac defects and oral clefts. Furthermore, the effects on the prevention of prematurity, foetal growth retardation and pre-eclampsia are unclear.Although the most common recommendation is to take 0.4 mg/day, the problem of the most appropriate dose of FA is still open.The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs. Other aims include the promotion of pre-conceptional counselling, comparing rates of selected CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age, abruptio placentae.Methods/DesignThis project is a joint effort by research groups in Italy and the Netherlands. Women of childbearing age, who intend to become pregnant within 12 months are eligible for the studies. Women are randomly assigned to receive 4 mg of FA (treatment in study) or 0.4 mg of FA (referent treatment) daily. Information on pregnancy outcomes are derived from women-and-physician information.We foresee to analyze the data considering all the adverse outcomes of pregnancy taken together in a global end point (e.g.: CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age). A total of about 1,000 pregnancies need to be evaluated to detect an absolute reduction of the frequency of 8%. Since the sample size needed for studying outcomes separately is large, this project also promotes an international prospective meta-analysis.DiscussionThe rationale of these randomized clinical trials (RCTs) is the hypothesis that a higher intake of FA is related to a higher risk reduction of NTDs, other CMs and other adverse pregnancy outcomes. Our hope is that these trials will act as catalysers, and lead to other large RCTs studying the effects of this supplementation on CMs and other infant and maternal outcomes.Trial registrationItalian trial: ClinicalTrials.gov Identifier: NCT01244347.Dutch trial: Dutch Trial Register ID: NTR3161.
The World Conferences on Research Integrity have produced significant collaborative conference statements including the Singapore Statement on Research Integrity and more recently the Hong Principles on Researcher Assessment. The 7th World Conference on Research Integrity (7WCRI) takes place in Cape Town from the 29th May 2022 to 1st June 2022. The theme of the conference is Fostering Research in an unequal world. We have proposed the Cape Town statement on Fostering Research Integrity through the promotion of fairness, equity and diversity in research collaborations and contexts as the major collaborative output for this conference. This paper serves to introduce the reader and conference attendees to the motivation and thinking behind this proposal which will be discussed further at the conference.The proposed Cape Town Statement needs to accomplish two aims. First it must clearly demonstrate why inequity and unfair practices in research collaborations and contexts is a research integrity (RI) matter. Second it must identify some key values or principles and action guides that will address the issue of equity and fairness in research within the context of the complete research life cycle from research agenda setting and call to proposal development, through grant application, allocation and management of funding, data production, analysis, management and sharing, to outputs, translation, and evaluation.This background paper serves to outline the rationale and justification for the proposed Cape Town Statement as a major collaborative output of the 7WCRI. It is not in itself the proposed statement but rather represents a summary of some of the thought processes and contributions thus far. We argue that the domain of RI and previous WCRI RI statements have focused the RI project primarily at a micro and meso or project level, with researchers and institutions being the main target for guidance. The Cape Town Statement project aims to widen the lens, bring in a macro perspective and ensure that other role players, including those that support global research structures and systems, are brought into focus, and encouraged to take accountability for their own spheres of influence.
Objectives To examine whether: 1) as people age, accumulation of negative events increases (‘sensitizing’) or decreases (‘steeling’) the detrimental effects of subsequent events on depressive symptoms, and 2) how particular psychosocial factors are associated with the strength of these steeling or sensitizing effects. Method We used data from six measurement waves from 2,069 adults aged 55-84 (M=68.0) at baseline in the Longitudinal Aging Study Amsterdam, the Netherlands. We included 18 different life events across the life course. Using hybrid multilevel models, we tested whether the effects of proximate life events (<3 years) on depressive symptoms (measured by the CES-D) were moderated by previous cumulative events (childhood until previous measurement wave). Additionally, we tested whether education, mastery, emotional support, neuroticism, having strong faith, and loneliness were associated with the strength of steeling/sensitizing effects. Results Cumulative and proximate life events were independently associated with more depressive symptoms. Interaction effects indicated that the more cumulative life events, the weaker the effects of recent life events, suggesting a ‘steeling’ effect. Unexpectedly, three-way interaction effects showed that higher mastery and lower neuroticism were associated with weaker steeling effects. These effects were predominantly attributable to within-person changes rather than to fixed between-person differences. Results from analyses with event severity scores were similar. Conclusions As a population, older adults appear to become more resilient against new stressors as they accumulate experience in dealing with negative life events. Findings on mastery tentatively suggest that accepting limits to one’s own control over life circumstances may foster a steeling effect.
Teaching responsible conduct of research (RCR) to PhD students is crucial for fostering responsible research practice. In this paper, we show how the use of Moral Case Deliberation—a case reflection method used in the Amsterdam UMC RCR PhD course—is particularity valuable to address three goals of RCR education: (1) making students aware of, and internalize, RCR principles and values, (2) supporting reflection on good conduct in personal daily practice, and (3) developing students’ dialogical attitude and skills so that they can deliberate on RCR issues when they arise. What makes this method relevant for RCR education is the focus on values and personal motivations, the structured reflection on real experiences and dilemmas and the cultivation of participants’ dialogical skills. During these structured conversations, students reflect on the personal motives that drive them to adhere to the principles of good science, thereby building connections between those principles and their personal values and motives. Moreover, by exploring personal questions and dilemmas related to RCR, they learn how to address these with colleagues and supervisors. The reflection on personal experiences with RCR issues and questions combined with the study of relevant normative frameworks, support students to act responsibly and to pursue RCR in their day-to-day research practice in spite of difficulties and external constraints.
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