Antiplatelet agents reduce spontaneous preterm birth in pregnant women at risk for preeclampsia.

a Background Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing data also allows for questions to be addressed at the meta-analysis level that cannot be addressed within individual studies. Purpose In this article, we offer some practical recommendations that will allow researchers to readily combine datasets from different studies and sources, thereby enabling meta-analyses that could have significant impact on advancing medicine. Methods The authors relied on their collective experience in the conduct and reporting of clinical trials to define the areas of potential concern related to responsible sharing of clinical trial data. We conducted a review of the literature and engaged in an iterative consensus-building process. Results To further the goal of responsible sharing of clinical trial data, collaboration on a consistent set of data standards and methods across both industry and academia is sorely needed. Protection of participant privacy is a paramount principle. The additional questions of who maintains, funds, and oversees databases of participantlevel data will be important to resolve. Requiring researchers to register their requests for participant-level data and to provide details of their intended research would allow others to evaluate the proposed research plan, consistent with the principles of science and transparency. Limitations The recommendations represent the views of the individual authors. We recognize that other approaches to data sharing that have been advocated are also based on sound ethical and scientific principles.

Background: There is accumulating evidence that digital breast tomosynthesis, referred to as 3D-mammography in this protocol, improves screen-detection measures compared to standard 2D-mammography in the context of population screening for breast cancer. However, the effect of 3D-mammography at follow-up of screened women is not yet known: it is unknown whether additional cancer detection from 3D-mammography leads to incremental screening benefit through a reduction of interval cancers, or whether it is mostly over-detecting indolent cancers. Methods:The aim of this study is to examine whether 3D-mammography population screening improves breast cancer screening effectiveness by reducing interval cancer rates compared to standard digital (2D) mammography screening, using individual participant data (IPD) meta-analysis. In this protocol, we outline the research plan which includes systematic identification of studies eligible to contribute data into the IPD meta-analysis, and sourcing and assembling IPD for participants screened with 3D-mammography (3D alone or integrated 2D/3D or integrated 2Dsynthetic/3D) and comparison participants screened with 2D-mammography (standard of care in breast screening). The primary end-point of this work is the interval breast cancer rate per 10,000 screens for 3D-mammography versus 2D-mammography screening. The IPD meta-analysis will also assess secondary outcomes including: screening sensitivity, cancer detection rates, cancer (prognostic) characteristics, and recall rates, for 3D-mammography versus 2D-mammography screening. The use of IPD meta-analysis will allow stratification of results by age and breast density, and will also facilitate analysis of cancer histological (prognostic) characteristics.Discussion: Finalization of data collection procedures and analysis plans will be complete by the end of 2017. Data collection will occur from late 2017 to late 2018 (screen-detection measures: cancer detection and recall data) and from mid-2018 to mid-2019 (interval cancer data). Results of detection measures should be available by 2019, and interval cancer results in 2020. By addressing the critical evidence gap on whether 3D-mammography screening reduces interval cancer rates (compared to 2D-mammography), we expect that our findings will inform timely translation of 3D-mammography technology into breast screening practice in population-based health programs.

Aspirin prophylaxis is recommended for women at higher risk of preeclampsia; yet, there is no consensus about the optimal dose. 1,2 Moreover, in North America, aspirin is routinely only available in 81 mg and 325 mg tablets. While a recent metaanalysis suggested a dose-response effect, 3 limitations therein included the inability to control for trial effects and maternal risk factors and a susceptibility to publication bias. Metaanalyses that use aggregate data pooled from different randomized controlled trials (RCTs) are also more likely to overestimate aspirin's efficacy compared with those metaanalyses that use

Specialised melanoma surveillance is likely to provide substantial cost savings for the Australian healthcare system.

Background Row-by-row individual participant data (IPD) from a set of similar studies allows meta-analyses with exposure, confounder and outcome standardisation, and additional analyses at little extra cost. The ICMJE recently declared data sharing an ethical obligation. Consequently, registries have introduced mandatory data sharing statements. Our aims were to analyse data sharing willingness, and identify barriers and facilitators to data sharing. Methods We included all trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) in 2019. We analysed data sharing statements from registry records, and conducted an in-depth survey. Associations between willingness to share data and trial characteristics (e.g. trial purpose, funding) were analysed. Results Of the 1,517 included trials, 23% planned to share IPD upon completion. Investigators were less willing to share IPD for industry-funded trials (OR = 0.50,95%CI=0.34-0.70), but there was no difference by sample size or health condition. The main reasons for not sharing IPD were concerns about participant privacy (22%), ethics approval limitations (19%) and lack of understanding for the need of IPD (17%). Among the 281 survey respondents, 78% supported data sharing, but only 40% intended to share their data. Major barriers included concerns about time/resources (96%) and insufficient academic recognition (91%). Conclusions There is insufficient willingness to share data, particularly among industry funders. Addressing the identified barriers can improve this. Key messages Data sharing enables the use of new methodologies, such as improved meta-analysis. Low willingness to share data jeopardises the use of these new methodologies and needs to be addressed.

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Background: The optimal duration of magnesium administration postpartum for prevention of eclampsia has not yet been established. Objective: To investigate the effect of early discontinuation of postpartum magnesium on the rates of postpartum eclampsia when compared to continuation for 24-hour postpartum. Search Strategy: Searches were performed using keywords related to "preeclampsia" and "magnesium sulfate" from inception of database until March 2019. Selection Criteria: Randomized controlled trials of women with preeclampsia receiving magnesium prior to delivery randomized to early discontinuation of magnesium postpartum. The control group was 24-hours of magnesium postpartum. Data Collection and Analysis: The primary outcome was the rate of postpartum eclampsia. Main Results: Eight RCTs with 2,183 women were included with five different magnesium administration time-frames. Eclampsia rates were not different between the two groups (5/1,088 (0.5%) after early discontinuation, versus 2/1,095 (0.2%) in the 24-hour group; RR 2.25, 95% CI 0.5-9.9, I2=0%, 8 studies, 2,183 participants). A number needed to treat was calculated; 370 women would need to receive 24-hours of magnesium postpartum to prevent one episode of postpartum eclampsia. The early discontinuation group had a significant decrease in time to ambulation and breastfeeding. Conclusions: Compared to continuation of magnesium for 24 hours postpartum, early magnesium discontinuation postpartum does not significantly increase the rate of postpartum eclampsia. The largest proportion of women did not receive magnesium postpartum after receiving at least 8 grams intrapartum, thus it is reasonable to consider discontinuation of magnesium postpartum if a woman has received similar adequate dose prior to delivery.