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Evaluation of the role of sex as a prognostic factor in critically ill adults with sepsis: systematic review protocol
  1. Jesus Lopez-Alcalde1,2,3,
  2. Alba Antequera Martín4,5,
  3. Elena Stallings2,
  4. Alfonso Muriel2,3,6,
  5. Borja Fernández-Félix2,3,
  6. Ivan Solà5,7,8,
  7. Rosa del Campo9,
  8. Manuel Ponce-Alonso9,
  9. Federico Gordo1,10,
  10. Pilar Fidalgo1,11,
  11. Ana Verónica Halperin9,
  12. Noelia Álvarez-Díaz12,
  13. Olaya Madrid-Pascual13,
  14. Gerard Urrutia5,7,8,
  15. Javier Zamora2,3
  1. 1Faculty of Health Sciences, Universidad Francisco de Vitoria, Pozuelo de Alarcón, Spain
  2. 2Clinical Biostatistics Unit, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain
  3. 3Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP), Madrid, Spain
  4. 4Autonomous University of Barcelona, Barcelona, Spain
  5. 5Biomedical Research Institute Sant Pau, Hospital Santa Cruz y San Pablo, Barcelona, Spain
  6. 6Department of Nursing and Physiotherapy, Universidad de Alcalá, Madrid, Spain
  7. 7Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP), Barcelona, Spain
  8. 8Iberoamerican Cochrane Centre, Barcelona, Spain
  9. 9Department of Microbiology, Hospital Universitario Ramón y Cajal, Madrid, Spain
  10. 10Department of Intensive Care, Hospital Universitario del Henares, Coslada, Madrid, Spain
  11. 11Department of Internal Medicine, Hospital Universitario del Henares, Coslada, Madrid, Spain
  12. 12Medical Library, Hospital Universitario Ramón y Cajal, Madrid, Madrid, Spain
  13. 13Arztpraxis Kalkbreite, Zurich, Switzerland
  1. Correspondence to Dr Alba Antequera Martín, Department of Epidemiology and Public Health, Biomedical Research Institute Sant Pau. Sant Antoni Maria Claret 167, building 18, 08025 Barcelona, Spain; alba.antequera.martin{at}gmail.com

Abstract

Introduction Sepsis is a leading cause of mortality in critically ill patients. Recently, it has been recognised that sex may contribute to a differential risk for developing sepsis and it remains uncertain if the prognosis of sepsis varies between the sexes. The aim of this systematic review is to summarise the available evidence to assess the role of sex as a prognostic factor in patients with sepsis managed in the intensive care unit (ICU).

Methods and analysis This is a systematic review protocol of prognostic studies of sex in patients with sepsis managed in the ICU. The primary outcomes include all-cause hospital mortality and all-cause hospital mortality during the first 28 days. The secondary outcomes include all-cause hospital mortality during the first 7 days and all-cause mortality at 1 year. We will conduct a search strategy based on the population (sepsis), the prognostic factor (sex), the outcome of interest (mortality) and prognostic study methods. We will search in the following databases up to December 2019: MEDLINE Ovid (from 1976), Embase Elsevier (from 1974), Web of Science and two trial registries. We will impose no language restrictions. Two authors will independently screen titles, abstracts and full-text articles for eligibility of studies, and subsequently extract data. Two authors will independently assess the risk of bias of each study using the Quality in Prognostic Studies (QUIPS) tool. If possible, we will carry out a meta-analysis to provide a pooled prognostic effect estimate for each outcome. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence.

Ethics and dissemination Ethical approval will not be required. Findings from this review will be reported in a peer-reviewed scientific journal. Additionally, the results will be disseminated at conferences and in the mass media.

PROSPERO registration number CRD42019145054.

  • adult intensive & critical care
  • infectious diseases
  • epidemiology
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Footnotes

  • Twitter @JLopezAlcalde

  • JL-A and AAM contributed equally.

  • Contributors Guarantor: JL-A. Conceiving of the review: JZ, JL-A, AAM. Designing protocol: JL-A, AAM, ES, JZ, IS. PROSPERO registration: AAM, JL-A. Designing research strategies: NA-D, IS, JL-A, AAM. Drafting of the manuscript; contributed equally to this work as first authors: AAM, JL-A. Methodological approach: JL-A, AAM, AM, IS, JZ, ES, GU. Clinical perspective: RdC, MP-A, FG, PF, AH, AAM. Screening search results: RdC, MP-A, PF, AH, OM-P, AAM, JL-A, FG. Analysing data: AM, AAM, JL-A, JZ, BF-F. Interpreting data: AAM, JL-A, AM, IS, JZ. Securing funding for the review: JL-A, JZ, GU. Critical revision of the manuscript for important intellectual content: All authors. Alba Antequera Martín is a doctoral candidate in Public Health and Methodology of Biomedical Research, at the Department of Pediatrics, Obstetrics, Gynaecology and Preventive Medicine at Universitat Autònoma de Barcelona (Spain) and this work is part of her PhD.

  • Funding The SEXCOMPLEX project was supported by Instituto de Salud Carlos III (Plan Estatal de I + D + i 2013–2016) and co-financed by the European Development Regional Fund 'A way to achieve Europe' (ERDF) grant number PIE16/00050. AAM was funded by the Instituto de Salud Carlos III through the “AcciónEstratégica en Salud 2013–2016 / Contratos Río Hortega call 2018/ CM18/00141” (Co-funded by European Social Fund 2014–2020, “Investing in your future”). BF-F was funded by Networking Biomedical Research Centre (CIBER). Publishing costs were provided by Networking Biomedical Research Centre (CIBER). These funding sources had no role in the design of this review, its execution, analyses, interpretation of the data, or decision to submit results.

  • Disclaimer The funding sources had no role in the design of this review, its execution, analyses, interpretation of the data or decision to submit results.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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