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Objective: To provide a framework for quantifying the robustness of treatment ranks based on Surface Under the Cumulative RAnking curve (SUCRA) in network meta-analysis (NMA) and investigating potential factors associated with lack of robustness., Methods: We propose the use of Cohen's kappa to quantify the agreement between SUCRA-based treatment ranks estimated through NMA of a complete data set and a subset of it. We illustrate our approach using five published NMA data sets, where robustness was assessed by removing studies one at a time., Results: Overall, SUCRA-based treatment ranks were robust to individual studies in the five data sets we considered. We observed more incidences of disagreement between ranks in the networks with larger numbers of treatments. Most treatments moved only one or two ranks up or down. The lowest quadratic weighted kappa estimate observed across all networks was in the network with the smallest number of treatments (4), where weighted kappa=40%. In the network with the largest number of treatments (12), the lowest observed quadratic weighted kappa=89%, reflecting a small shift in this network's treatment ranks overall. Preliminary observations suggest that a study's size, the number of studies making a treatment comparison, and the agreement of a study's estimated treatment effect(s) with those estimated by other studies making the same comparison(s) may explain the overall robustness of treatment ranks to studies., Conclusions: Investigating robustness or sensitivity in an NMA may reveal outlying rank changes that are clinically or policy-relevant. Cohen's kappa is a useful measure that permits investigation into study characteristics that may explain varying sensitivity to individual studies. However, this study presents a framework as a proof of concept and further investigation is required to identify potential factors associated with the robustness of treatment ranks using more extensive empirical evaluations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Birth weight is an indicator of newborn health and a strong predictor of health outcomes in later life. Significant variation in diet during pregnancy between ethnic groups in high-income countries provides an ideal opportunity to investigate the influence of maternal diet on birth weight., Setting: Four multiethnic birth cohorts based in Canada (the NutriGen Alliance)., Participants: 3997 full-term mother-infant pairs of diverse ethnic groups who had principal component analysis-derived diet pattern scores-plant-based, Western and health-conscious-and birth weight data., Results: No associations were identified between the Western and health-conscious diet patterns and birth weight; however, the plant-based dietary pattern was inversely associated with birth weight (β=-67.6 g per 1-unit increase; P<0.001), and an interaction with non-white ethnicity and birth weight was observed. Ethnically stratified analyses demonstrated that among white Europeans, maternal consumption of a plant-based diet associated with lower birth weight (β=-65.9 g per 1-unit increase; P<0.001), increased risk of small-for-gestational age (SGA; OR=1.46; 95% CI 1.08 to 1.54;P=0.005) and reduced risk of large-for-gestational age (LGA; OR=0.71; 95% CI 0.53 to 0.95;P=0.02). Among South Asians, maternal consumption of a plant-based diet associated with a higher birth weight (β=+40.5 g per 1-unit increase; P=0.01), partially explained by cooked vegetable consumption., Conclusions: Maternal consumption of a plant-based diet during pregnancy is associated with birth weight. Among white Europeans, a plant-based diet is associated with lower birth weight, reduced odds of an infant born LGA and increased odds of SGA, whereas among South Asians living in Canada, a plant-based diet is associated with increased birth weight., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: There has been increasing interest in pragmatic trials methodology. As a result, tools such as the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) are being used prospectively to help researchers design randomised controlled trials (RCTs) within the pragmatic-explanatory continuum. There may be value in applying the PRECIS-2 tool retrospectively in a systematic review setting as it could provide important information about how to pool data based on the degree of pragmatism., Objectives: To investigate the role of pragmatism as a source of heterogeneity in systematic reviews by (1) identifying systematic reviews with meta-analyses of RCTs that have moderate to high heterogeneity, (2) applying PRECIS-2 to RCTs of systematic reviews, (3) evaluating the inter-rater reliability of PRECIS-2, (4) determining how much of this heterogeneity may be explained by pragmatism., Methods: A cross-sectional methodological review will be conducted on systematic reviews of RCTs published in the Cochrane Library from 1 January 2014 to 1 January 2017. Included systematic reviews will have a minimum of 10 RCTs in the meta-analysis of the primary outcome and moderate to substantial heterogeneity (I 2 ≥50%). Of the eligible systematic reviews, a random selection of 10 will be included for quantitative evaluation. In each systematic review, RCTs will be scored using the PRECIS-2 tool, in duplicate. Agreement between raters will be measured using the intraclass correlation coefficient. Subgroup analyses and meta-regression will be used to evaluate how much variability in the primary outcome may be due to pragmatism., Dissemination: This review will be among the first to evaluate the PRECIS-2 tool in a systematic review setting. Results from this research will provide inter-rater reliability information about PRECIS-2 and may be used to provide methodological guidance when dealing with pragmatism in systematic reviews and subgroup considerations. On completion, this review will be submitted to a peer-reviewed journal for publication., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: Interrupted time series (ITS) design involves collecting data across multiple time points before and after the implementation of an intervention to assess the effect of the intervention on an outcome. ITS designs have become increasingly common in recent times with frequent use in assessing impact of evidence implementation interventions. Several statistical methods are currently available for analysing data from ITS designs; however, there is a lack of guidance on which methods are optimal for different data types and on their implications in interpreting results. Our objective is to conduct a scoping review of existing methods for analysing ITS data, to summarise their characteristics and properties, as well as to examine how the results are reported. We also aim to identify gaps and methodological deficiencies., Methods and Analysis: We will search electronic databases from inception until August 2016 (eg, MEDLINE and JSTOR). Two reviewers will independently screen titles, abstracts and full-text articles and complete the data abstraction. The anticipated outcome will be a summarised description of all the methods that have been used in analysing ITS data in health research, how those methods were applied, their strengths and limitations and the transparency of interpretation/reporting of the results. We will provide summary tables of the characteristics of the included studies. We will also describe the similarities and differences of the various methods., Ethics and Dissemination: Ethical approval is not required for this study since we are just considering the methods used in the analysis and there will not be identifiable patient data. Results will be disseminated through open access peer-reviewed publications., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Parenteral anticoagulants may improve outcomes in patients with cancer by reducing risk of venous thromboembolic disease and through a direct antitumour effect. Study-level systematic reviews indicate a reduction in venous thromboembolism and provide moderate confidence that a small survival benefit exists. It remains unclear if any patient subgroups experience potential benefits., Methods and Analysis: First, we will perform a comprehensive systematic search of MEDLINE, EMBASE and The Cochrane Library, hand search scientific conference abstracts and check clinical trials registries for randomised control trials of participants with solid cancers who are administered parenteral anticoagulants. We anticipate identifying at least 15 trials, exceeding 9000 participants. Second, we will perform an individual participant data meta-analysis to explore the magnitude of survival benefit and address whether subgroups of patients are more likely to benefit from parenteral anticoagulants. All analyses will follow the intention-to-treat principle. For our primary outcome, mortality, we will use multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect. We will adjust analysis for important prognostic characteristics. To investigate whether intervention effects vary by predefined subgroups of patients, we will test interaction terms in the statistical model. Furthermore, we will develop a risk-prediction model for venous thromboembolism, with a focus on control patients of randomised trials., Ethics and Dissemination: Aside from maintaining participant anonymity, there are no major ethical concerns. This will be the first individual participant data meta-analysis addressing heparin use among patients with cancer and will directly influence recommendations in clinical practice guidelines. Major cancer guideline development organisations will use eventual results to inform their guideline recommendations. Several knowledge users will disseminate results through presentations at clinical rounds as well as national and international conferences. We will prepare an evidence brief and facilitate dialogue to engage policymakers and stakeholders in acting on findings., Trial Registration Number: PROSPERO CRD42013003526., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)