NDLI: Stress ulcer prophylaxis versus placebo or no prophylaxis in adult hospitalised acutely ill patients—protocol for a systematic review with meta-analysis and trial sequential analysis

Content Provider	Springer Nature : BioMed Central
Author	Marker, Søren Perner, Anders Wetterslev, Jørn Barbateskovic, Marija Jakobsen, Janus Christian Krag, Mette Granholm, Anders Anthon, Carl Thomas Møller, Morten Hylander
Abstract	Background Stress ulcer prophylaxis is considered standard of care in many critically ill patients in the intensive care unit (ICU). However, the quality of evidence supporting this has recently been questioned, and clinical equipoise exists. Whether there is overall benefit or harm of stress ulcer prophylaxis in adult hospitalised acutely ill patients is unknown. Accordingly, we aim to assess patient-important benefits and harms of stress ulcer prophylaxis versus placebo or no treatment in adult hospitalised acutely ill patients with high risk of gastrointestinal bleeding irrespective of hospital setting. Methods/design We will conduct a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis and assess use of proton pump inhibitors (PPIs) or histamine-2-receptor antagonists (H2RAs) in any dose, formulation and duration. We will accept placebo or no prophylaxis as control interventions. The participants will be adult hospitalised acutely ill patients with high risk of gastrointestinal bleeding. We will systematically search the Cochrane Library, MEDLINE, EMBASE, Science Citation Index, BIOSIS and Epistemonikos for relevant literature. We will follow the recommendations by the Cochrane Collaboration and the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. The risk of systematic errors (bias) and random errors will be assessed, and the overall quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Discussion There is a need for a high-quality systematic review to summarise the benefits and harms of stress ulcer prophylaxis in hospitalised patients to inform practice and future research. Although stress ulcer prophylaxis is used worldwide, no firm evidence for benefit or harm as compared to placebo or no treatments has been established. Critical illness is a continuum not limited to the ICU setting, which is why it is important to assess the benefits and harms of stress ulcer prophylaxis in a wider perspective than exclusively in ICU patients. Systematic review registration PROSPERO CRD42017055676
Related Links	https://systematicreviewsjournal.biomedcentral.com/counter/pdf/10.1186/s13643-017-0509-4.pdf
Ending Page	8
Page Count	8
Starting Page	1
File Format	HTM / HTML
ISSN	20464053
DOI	10.1186/s13643-017-0509-4
Journal	Systematic Reviews
Issue Number	1
Volume Number	6
Language	English
Publisher	BioMed Central
Publisher Date	2017-06-24
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Acid suppressants Gastrointestinal bleeding Risk factors Side effects Stress ulcer prophylaxis Proton pump inhibitors Histamine-2-receptor antagonists Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine
Journal Impact Factor	6.3/2023
5-Year Journal Impact Factor	4.5/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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