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      Controversies in the application of corticosteroids for pediatric septic shock treatment: a preferred reporting items for systematic reviews and meta-analysis-compliant updated meta-analysis

      , MD a , , , MD b

      Medicine

      Wolters Kluwer Health

      corticosteroids, meta-analysis., pediatric, septic shock, systematic review

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          Abstract

          Supplemental Digital Content is available in the text

          Abstract

          Objectives:

          Septic shock is the major cause of childhood mortality. However, the application of corticosteroids remains controversial. This work aimed to analyze the source of controversy based on existing data and recent randomized controlled trials by meta-analysis and to assess whether it can avoid these factors to guide clinical treatment.

          Methods:

          We searched the public databases up to 8 June 2019 and included only randomized controlled trials. The primary outcome was mortality. Sensitivity analysis, subgroup analysis, and dose-response meta-analysis were performed in this work.

          Results:

          We included twelve studies consisting of 701 children in the meta-analysis. For primary outcome, the fixed-effect model showed steroids could significantly reduce the mortality compared to the control (Odds Ratio: 0.67; 95% confidence interval: 0.46–0.98; P = .041). However, the random-effect model showed a negative result (Odds Ratio: 0.69; 95% confidence interval: 0.32–1.51; P = .252). None of the subgroup results rejected the null hypothesis that the overall effect equaled zero. Dose-response effect analysis showed that increased dosage at a low dosage might reduce the mortality, while at a high dosage, increasing the dose might increase the mortality. Moreover, the grading of recommendations assessment, development, and evaluation level of evidence is low for mortality.

          Conclusions:

          Corticosteroid application is not recommended for septic shock children under current medical conditions.

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          Most cited references 35

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          The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016)

          Background and purpose The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016), a Japanese-specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 and published in the Journal of JSICM, [2017; Volume 24 (supplement 2)] 10.3918/jsicm.24S0001 and Journal of Japanese Association for Acute Medicine [2017; Volume 28, (supplement 1)] http://onlinelibrary.wiley.com/doi/10.1002/jja2.2017.28.issue-S1/issuetoc. This abridged English edition of the J-SSCG 2016 was produced with permission from the Japanese Association of Acute Medicine and the Japanese Society for Intensive Care Medicine. Methods Members of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ) and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two-thirds (> 66.6%) majority vote of each of the 19 committee members. Results A total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J-SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation, and its supporting evidence were also added to each recommendation statement. We conducted meta-analyses for 29 CQs. Thirty-seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for five CQs. Conclusions Based on the evidence gathered, we were able to formulate Japanese-specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non-specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals. Electronic supplementary material The online version of this article (10.1186/s40560-017-0270-8) contains supplementary material, which is available to authorized users.
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            Corticosteroid therapy for sepsis: a clinical practice guideline

            What you need to know Sepsis is a syndrome of life threatening infection with organ dysfunction, and most guidelines do not advise use of corticosteroids to treat it in the absence of refractory shock Two new trials of corticosteroid treatment for sepsis came to differing conclusions Corticosteroids may reduce the risk of death by a small amount and increase neuromuscular weakness by a small amount, but the evidence is not definitive This guideline makes a weak recommendation for corticosteroids in patients with sepsis; both steroids and no steroids are reasonable management options Fully informed patients who value avoiding death over quality of life and function would likely choose corticosteroids Do corticosteroids reduce death or improve recovery in people with sepsis or septic shock? Our panel make a weak recommendation to give corticosteroids to people with all types and severity of sepsis, based on new evidence. Because we are not certain that they are beneficial, it is also reasonable not to prescribe them. Patients’ values and preferences may guide this decision-making process. This rapid recommendation was triggered by two trials, with differing conclusions whose results might change practice: ADRENAL (3658 patients who had septic shock) found no statistically significant difference in 90 day mortality between the hydrocortisone and placebo groups.1 APROCCHSS (1241 patients who had septic shock) found that hydrocortisone plus fludrocortisone reduced 90 day mortality.2 The trials are incorporated into a linked systematic review comparing corticosteroids with placebo.3 This BMJ Rapid Recommendation promptly and transparently translates this evidence using GRADE methodology for trustworthy guidelines. Sepsis is a life threatening organ dysfunction from infection. Currently most guidelines advise against giving corticosteroids in sepsis in the absence of refractory shock, but these guidelines have not taken into account the new evidence. We do not anticipate that new clinical trials will substantively alter the evidence suggesting a small but uncertain mortality reduction. Box 1 shows publications linked in this Rapid Recommendation package. The main infographic provides an overview of the absolute benefits and harms. The table at the end of the article shows any evidence that has emerged since the publication of this guideline. Box 1 Linked articles in the BMJ Rapid Recommendation cluster Lamontagne F, Rochwerg B, Lytvyn L, et al. Corticosteroid therapy for sepsis: a clinical practice guideline. BMJ 2018;362:k3284 Summary of the results from the Rapid Recommendation process Rochwerg B, Oczkowski SJ, Siemieniuk RAC, et al. Corticosteroids in sepsis: an updated systematic review and meta-analysis. Crit Care Med 2018. doi:10.1097/CCM.0000000000003262 3 Review and meta-analysis of all available randomised trials that assessed corticosteroid therapy for sepsis MAGICapp (https://app.magicapp.org/public/guideline/EZ1w8n) Expanded version of the results with multilayered recommendations, evidence summaries, and decision aids for use on all devices Current understanding Sepsis is life threatening organ dysfunction caused by a dysregulated host response to infection.4 In practice, a sepsis-related organ failure assessment (SOFA) score of ≥2 in patients with infections is sepsis (table 1).4 5 Worldwide, about 30 million people are hospitalised with sepsis every year and up to six million of them die.6 Table 1 Sepsis-related organ failure assessment (SOFA) score to help diagnose sepsis (adapted from Vincent et al5)* System or organ and measure SOFA score 0 1 2 3 4 Respiratory:  PaO2/FiO2, mm Hg ≥400 300-399 200-299 100-199 with respiratory support 204 (12.0) Circulatory:  Mean arterial pressure, mm Hg ≥70 440 (5.0)  Urine output, mL/day – – – 14 days) might be particularly likely to benefit from a taper before discontinuing and an evaluation of hypothalamo-pituitary-adrenal axis function if in doubt.12 Costs Corticosteroids are typically inexpensive and widely available. The impact of corticosteroids on the overall costs to patients and to health systems is uncertain and would be driven mostly by ICU and hospital lengths of stay or prolonged periods of rehabilitation. Future research With the exception of the awaited analysis of quality of life in the ADRENAL trial, there are currently no planned or ongoing RCTs in patients who have sepsis that are likely to substantively change the overall effect estimates for the key outcomes. Given remaining uncertainty regarding the effect of corticosteroids in different subgroups, additional analyses of existing data to explore heterogeneity of treatment effects are logical next steps before more patients are enrolled in similar trials. Such work mandates individual patient-data meta-analyses that rely on investigators sharing the data from their RCTs and cooperation among research networks. It is possible that additional adaptive RCTs could help to resolve remaining uncertainty. Key research questions to inform decision makers and future guidelines are: What is the impact of corticosteroid therapy on quality of life in the short and long term? What is the impact of corticosteroid therapy on functional recovery? What is the impact of corticosteroid therapy on healthcare costs? Are there subgroups of patients with sepsis who benefit more or less from corticosteroid therapy? Are there differences between bolus and infusion dosing? Does the addition of fludrocortisone improve outcomes? Updates to this article The final table shows evidence that has emerged since the publication of this article. As new evidence is published, a group will assess the new evidence and make a judgment on to what extent it is expected to alter the recommendation. New evidence which has emerged after initial publication Date New evidence Citation Findings Implications for recommendation(s) There are currently no updates to the article.
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              American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy

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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                24 July 2020
                24 July 2020
                : 99
                : 30
                Affiliations
                [a ]Department of Pediatric Respiration, Lanzhou University Second Hospital
                [b ]College of Pharmacy, Gansu University of Chinese Medicine, Lanzhou, Gansu, P R. China.
                Author notes
                []Correspondence: Jing Yang, No. 80, Cuiyingmen, Chengguan District, Lanzhou City, Gansu province, P R. China, 730000 (e-mail: yangjing037@ 123456126.com ).
                Article
                MD-D-19-08311 20762
                10.1097/MD.0000000000020762
                7386966
                Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0

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