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      Reproductive Health is pleased to announce a mandatory open data policy in the journal

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      Reproductive Health
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          Abstract

          Introduction The field of global health is evolving and moving forward from not just securing open access publication to aid in the dissemination of research but further still, making the data underpinning the results of that publication open. Funders1 in the field, and recently the International Committee of Medical Journal Editors (ICMJE) [1], are increasingly requiring that researchers make data produced during their grants publicly accessible. Although the push for more data sharing and transparency started with the genomics community, it is quickly spreading to the global health communities. Indeed, two major organisations in the field have already set up a strong infrastructure for data reuse and sharing. Many of us are already familiar with the power of open data through the WHO Global Health Observatory Data Repository [2] and the World Bank Open Data Catalogue [3], both of which are invaluable resources. In February 2016 the Wellcome Trust also joined ‘over 30 global health bodies in calling for all research data gathered during the Zika virus outbreak, and future public health emergencies, to be made available as rapidly and openly as possible’ [4]. This follows a consensus statement arising from a WHO consultation in September 2015 moving towards making this the global norm [5]. Reproductive Health wants to help spearhead this paradigm shift to ensure all data underlying the research published within the journal is publicly available to ensure transparency of research and contribute to enhancing research in the field. Why open data? Open Data—such as that found in the WHO Global Health Observatory Data Repository and from the World Bank—is especially important in the field of global health. Public health on a global scale requires the statistical power of pools of data rather than individual datasets. We need a bird’s eye view to detect trends and combat global epidemics. Examples of the benefits of sharing data to global health research exist beyond the community resources mentioned from the WHO and World Bank. The Consortium of Health-Orientated Research in Transitioning Societies (COHORTS) study is one such example [6]. Funded by the Wellcome Trust and led by Cesar Victora, one group of researchers pooled data from 5 major cohort studies on maternal and infant factors in low and middle income countries. This larger pool of data provided relevant information about the relevance of the first 1000 days of life on further quality of life and educational attainment and earnings. Pooling their data gave the researchers enhanced statistical power and enabled them to generate more information around the impact on the first 1000 days of life. This example highlights how greater data sharing through collaboration can greatly benefit the individual researcher, leading to more prestigious and more impactful publications. But reuse of, and the potential for, open data is only one of the driving factors. Also key to this conversation around data access is transparency. Health interventions must be driven by evidence, and that evidence must be verifiable. Well established organisations in the global health community have overstated the case for certain health interventions, polarising views on the use of certain interventions. A good example is the secondary analyses of the WHO Antenatal Care trial performed by Vogel et al. [7]. The large, cluster randomized WHO Antenatal Care Trial concluded that a goal-orientated package of antenatal care with reduced visits seemed not to affect maternal and perinatal outcomes [8]. This secondary analysis of the WHO Antenatal Care Trial data indicates that there is an appreciable increased risk of fetal death at 32 to 36 weeks gestation for women receiving the goal-oriented, reduced frequency antenatal care package. In a Commentary regarding the publication of this secondary analysis, Hofmeyr and Hodnett [9] concluded that “this re-analysis was robust after adjustment for potential confounding factors, and that the increase in perinatal mortality (was) consistent with trends in the two other cluster randomized trials conducted in Zimbabwe [10], we find the evidence, that a reduced number of antenatal visits is associated with increased perinatal mortality, compelling” [9]. Derivatives of these conclusions are of great magnitude since the WHO Antenatal Care Trial paper and derived publications such as the WHO manual for the implementation of the new model (http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/RHR_01_30/en/index.html) have impacted antenatal care practice in many low-income countries. What is needed in health interventions is an objective, depoliticized view of the evidence. That kind of clarity comes with data transparency. Increased data access will also help to catch mistakes in reported results, which inevitably happen. Ways forward Data policy In line with the above and to solidify our commitment in ensuring research data is made publicly available, Reproductive Health will be introducing a mandatory data sharing policy. We will be recommending that authors publish their data before submission in the Dataverse repository [11], a general repository run out of Harvard which charges no fee for storing up to 5GB of data. We also recommend authors utilise the following checklist when planning to deposit their data into their chosen repository: http://mozillascience.github.io/checklist/ [12]. Data notes In addition to this policy change, Reproductive Health has introduced a ‘Data Note’ as an article type [13] which authors are now able to select during submission. This article type is 3–4 pages in length and makes datasets open ahead of research findings being published. We have also updated the Instructions for Authors to include a section on ‘Availability of supporting data’. If you have any queries regarding the introduction of this new policy, please feel free to contact the Journal Editorial Office on reproductivehealthjournal@biomedcentral.com. We are excited about this new chapter in Reproductive Health and look forward to receiving your Data Notes.

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          WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care.

          We undertook a multicentre randomised controlled trial that compared the standard model of antenatal care with a new model that emphasises actions known to be effective in improving maternal or neonatal outcomes and has fewer clinic visits. Clinics in Argentina, Cuba, Saudi Arabia, and Thailand were randomly allocated to provide either the new model (27 clinics) or the standard model currently in use (26 clinics). All women presenting for antenatal care at these clinics over an average of 18 months were enrolled. Women enrolled in clinics offering the new model were classified on the basis of history of obstetric and clinical conditions. Those who did not require further specific assessment or treatment were offered the basic component of the new model, and those deemed at higher risk received the usual care for their conditions; however, all were included in the new-model group for the analyses, which were by intention to treat. The primary outcomes were low birthweight (<2500 g), pre-eclampsia/eclampsia, severe postpartum anaemia (<90 g/L haemoglobin), and treated urinary-tract infection. There was an assessment of quality of care and an economic evaluation. Women attending clinics assigned the new model (n=12568) had a median of five visits compared with eight within the standard model (n=11958). More women in the new model than in the standard model were referred to higher levels of care (13.4% vs 7.3%), but rates of hospital admission, diagnosis, and length of stay were similar. The groups had similar rates of low birthweight (new model 7.68% vs standard model 7.14%; stratified rate difference 0.96 [95% CI -0.01 to 1.92]), postpartum anaemia (7.59% vs 8.67%; 0.32), and urinary-tract infection (5.95% vs 7.41%; -0.42 [-1.65 to 0.80]). For pre-eclampsia/eclampsia the rate was slightly higher in the new model (1.69% vs 1.38%; 0.21 [-0.25 to 0.67]). Adjustment by several confounding variables did not modify this pattern. There were negligible differences between groups for several secondary outcomes. Women and providers in both groups were, in general, satisfied with the care received, although some women assigned the new model expressed concern about the timing of visits. There was no cost increase, and in some settings the new model decreased cost. Provision of routine antenatal care by the new model seems not to affect maternal and perinatal outcomes. It could be implemented without major resistance from women and providers and may reduce cost.
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            Antenatal care packages with reduced visits and perinatal mortality: a secondary analysis of the WHO Antenatal Care Trial

            Background In 2001, the WHO Antenatal Care Trial (WHOACT) concluded that an antenatal care package of evidence-based screening, therapeutic interventions and education across four antenatal visits for low-risk women was not inferior to standard antenatal care and may reduce cost. However, an updated Cochrane review in 2010 identified an increased risk of perinatal mortality of borderline statistical significance in three cluster-randomized trials (including the WHOACT) in developing countries. We conducted a secondary analysis of the WHOACT data to determine the relationship between the reduced visits, goal-oriented antenatal care package and perinatal mortality. Methods Exploratory analyses were conducted to assess the effect of baseline risk and timing of perinatal death. Women were stratified by baseline risk to assess differences between intervention and control groups. We used linear modeling and Poisson regression to determine the relative risk of fetal death, neonatal death and perinatal mortality by gestational age. Results 12,568 women attended the 27 intervention clinics and 11,958 women attended the 26 control clinics. 6,160 women were high risk and 18,365 women were low risk. There were 161 fetal deaths (1.4%) in the intervention group compared to 119 fetal deaths in the control group (1.1%) with an increased overall adjusted relative risk of fetal death (Adjusted RR 1.27; 95% CI 1.03, 1.58). This was attributable to an increased relative risk of fetal death between 32 and 36 weeks of gestation (Adjusted RR 2.24; 95% CI 1.42, 3.53) which was statistically significant for high and low risk groups. Conclusion It is plausible the increased risk of fetal death between 32 and 36 weeks gestation could be due to reduced number of visits, however heterogeneity in study populations or differences in quality of care and timing of visits could also be playing a role. Monitoring maternal, fetal and neonatal outcomes when implementing antenatal care protocols is essential. Implementing reduced visit antenatal care packages demands careful monitoring of maternal and perinatal outcomes, especially fetal death.
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              Antenatal care packages with reduced visits and perinatal mortality: a secondary analysis of the WHO antenatal care trial - Comentary: routine antenatal visits for healthy pregnant women do make a difference

              The practice and timing of routine antenatal visits for healthy pregnant women, introduced arbitrarily and without evidence of effectiveness, have become entrenched in obstetric practice over the last century. In 2001 the large, cluster randomized WHO Antenatal Care Trial concluded that a goal-orientated package of antenatal care with reduced visits seemed not to affect maternal and perinatal outcomes. The reduced visit package has been implemented in several countries. The current re-analysis finds that the significantly increased perinatal mortality which occurred in the reduced visit package persists after adjustment for potential confounding factors. The WHO Antenatal Care Trial provided the first evidence from a randomized trial that the traditional high frequency of routine visits in the third trimester may well reduce perinatal mortality.
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                Author and article information

                Contributors
                Natasha.salaria@biomedcentral.com
                Journal
                Reprod Health
                Reprod Health
                Reproductive Health
                BioMed Central (London )
                1742-4755
                13 June 2016
                13 June 2016
                2016
                : 13
                Affiliations
                [ ]BioMed Central, London, UK
                [ ]Institute for Clinical Effectiveness and Health Policy (IECS), London, UK
                Article
                190
                10.1186/s12978-016-0190-4
                4906732
                27296276
                98e51129-b571-4f6a-a44d-824116e011bc
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Editorial
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                © The Author(s) 2016

                Obstetrics & Gynecology
                Obstetrics & Gynecology

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