Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
BACKGROUND: Since the placenta also has a sex, fetal sex-specific differences in the occurrence of placenta-mediated complications could exist.OBJECTIVE: To determine the association of fetal sex with multiple maternal pregnancy complications.SEARCH STRATEGY: Six electronic databases Ovid MEDLINE, EMBASE, Cochrane Central, Web-of-Science, PubMed, and Google Scholar were systematically searched to identify eligible studies. Reference lists of the included studies and contact with experts were also used for identification of studies.SELECTION CRITERIA: Observational studies that assessed fetal sex and the presence of maternal pregnancy complications within singleton pregnancies.DATA COLLECTION AND ANALYSES: Data were extracted by 2 independent reviewers using a predesigned data collection form.MAIN RESULTS: From 6522 original references, 74 studies were selected, including over 12,5 million women. Male fetal sex was associated with term pre-eclampsia (pooled OR 1.07 [95%CI 1.06 to 1.09]) and gestational diabetes (pooled OR 1.04 [1.02 to 1.07]). All other pregnancy complications (i.e., gestational hypertension, total pre-eclampsia, eclampsia, placental abruption, and post-partum hemorrhage) tended to be associated with male fetal sex, except for preterm pre-eclampsia, which was more associated with female fetal sex. Overall quality of the included studies was good. Between-study heterogeneity was high due to differences in study population and outcome definition.CONCLUSION: This meta-analysis suggests that the occurrence of pregnancy complications differ according to fetal sex with a higher cardiovascular and metabolic load for the mother in the presence of a male fetus.FUNDING: None.
Introduction: Shared decision-making is considered to be a key aspect of woman-centered care and a strategy to improve communication, respect, and satisfaction. This scoping review identified studies that used a shared decision-making support strategy as the primary intervention in the context of perinatal care. Methods: A literature search of PubMed, CINAHL, Cochrane Library, PsycINFO, and SCOPUS databases was completed for English-language studies conducted from January 2000 through November 2019 that examined the impact of a shared decision-making support strategy on a perinatal decision (such as choice of mode of birth after prior cesarean birth). Studies that only examined the use of a decision aid were excluded. Nine studies met inclusion criteria and were examined for the nature of the shared decision-making intervention as well as outcome measures such as decisional evaluation, including decisional conflict, decisional regret, and certainty. Results: The 9 included studies were heterogeneous with regard to shared decision-making interventions and measured outcomes and were performed in different countries and in a variety of perinatal situations, such as women facing the choice of mode of birth after prior cesarean birth. The impact of a shared decision-making intervention on women’s perception of shared decision-making and on their experiences of the decision-making process were mixed. There may be a decrease in decisional conflict and regret related to feeling informed, but no change in decisional certainty. Discussion: Despite the call to increase the use of shared decision-making in perinatal care, there are few studies that have examined the effects of a shared decision-making support strategy. Further studies that include antepartum and intrapartum settings, which include common perinatal decisions such as induction of labor, are needed. In addition, clear guidance and strategies for successfully integrating shared decision-making and practice recommendations would help women and health care providers navigate these complex decisions.
Zijn data-analyse en bio-informatica de sleutel naar voorspellingen over de invloed van giftige stoffen op de gezondheid van mensen? Het project DART Pathfinder is een vervolgonderzoek naar een dierproefvrije testmethode. Met moderne ICT-technieken proberen we die voorspellingen te doen.Doel Het doel van dit project is om gegevens over giftige stoffen uit verschillende data bronnen samen te brengen. In het onderzoek gebruiken we technieken uit de bio-informatica. Zo willen we de eigenschappen van giftige stoffen beter in kaart brengen en (nadelige) effecten van soortgelijke stoffen kunnen voorspellen. Veel bedrijven maken producten of stoffen, die getest moeten worden of ze veilig zijn. Met dit project helpen we bedrijven om o.b.v. bestaande gegevens een betere keuze te maken welke testen ze hiervoor het beste kunnen gebruiken. Resultaten Kennis over computer modellen die voorspellingen doen, zoals machine learning, regression tree-based models; Nieuwe algoritmen (instructies om berekeningen uit te voeren) Inzicht in nieuwe biologische mechanismen obv data science Nieuwe statische methoden om data te analysen en voorspellingen te doen. Looptijd 01 februari 2018 - 01 februari 2022 Aanpak Met de gegevens uit het onderzoek maken we een computermodel dat voorspelt of giftige stoffen invloed hebben op de voortplanting en ontwikkeling van mensen. Die voorspelling gebeurt via machine learning, algoritmen en statistische methoden. Voor dit model wordt informatie uit publieke databases over fysische en chemische eigenschappen van mogelijk gevaarlijke stoffen samengevoegd met de gegevens over de invloed van deze stoffen op levende organismen. Net als in het eerste onderzoek (PreDART) werken we met rondwormen (C.elegans) en embryo's van zebravissen, met als doel geen proeven meer met ratten en konijnen te hoeven doen.
In TOX FLOW ontwikkelen we proefdiervrije methoden om de invloed van giftige stoffen en complexe mengsels op de voortplanting en ontwikkeling van embryo's te bestuderen.Doel We willen met het project TOX FLOW dierproefvrije methoden ontwikkelen om de invloed van giftige stoffen op de voortplanting en ontwikkeling van embryo's te kunnen voorspellen. Het kost veel tijd en geld om veel verschillende chemische stoffen te testen mbv dierproeven. Bedrijven en overheden willen daarom graag dat er betrouwbare dierproefvrije methoden worden ontwikkeld, die ook geaccepteerd worden door regelgevende instanties in Europa (en daar buiten). Resultaten We brengen de inzichten uit het onderzoek in praktijk door: Standaardprocedures voor verschillende testmethoden beschikbaar te stellen Wetenschappelijke artikelen en presentaties voor onderzokers, bedrijven en overheden Europees Fonds voor Regionale Ontwikkeling (EFRO) is daarnaast bedoeld om economische groei te stimuleren. Er is veel aandacht voor commerciele toepassing van de resultaten Protocollen en stageplaatsen voor studenten uit het bachelor onderwijs. Looptijd 01 december 2018 - 31 december 2022 Aanpak In dit project worden eerder ontwikkelde methoden (met de worm C elegans, zebravisembryo’s en stamcellen) gecombineerd met in vitro huidmodellen om de effecten van complexe verbindingen te kunnen testen. Huidmodellen worden gebruikt om de blootstelling aan deze stoffen via de huid te kunnen meten. Dit onderzoek is van belang voor bedrijven die (chemische) producten ontwikkelen of hun producten op dierproeven laten testen door contract laboratoria (CRO's). Dit onderzoek is een vervolg op het project PreDART. DART staat voor Development And Reproduction Toxicology en wordt ook wel ontwikkelings- en reproductietoxicologie genoemd.Vrijwel alle bedrijven in de chemische industrie moeten hier op verplicht hun producten testen vanwege de Europese wet REACH.
