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

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

Prophylactic use of acid suppressants in adult acutely ill hospitalised patients: A systematic review with meta‐analysis and trial sequential analysis

“…We included randomised clinical trials (RCTs) comparing SUP with either PPI or H2RA versus placebo or no prophylaxis in acutely ill hospitalised adult patients (as defined by the investigators) irrespective of hospital setting. We accepted the intervention in any dose, formulation and treatment duration and excluded trials that were quasi‐randomised, used crossover and trials where patients were not acutely admitted to the hospital …”

“…Two review authors (SM and MB) independently and in duplicate extracted predefined data of the included trials using a predefined data collection form (S3, ESM). The following data were collected: (a) trial: country, duration of the trial, date of publication and type of trial (single‐ vs multicentre); (b) participants: numbers randomised, numbers analysed, numbers lost to follow‐up/withdrawn, type of population, mean/median age, sex, inclusion criteria and exclusion criteria; (c) interventions: intervention, comparator and concomitant interventions; (d) outcomes: predefined primary and secondary outcomes …”

Effects of adding adjunctive hyperbaric oxygen therapy to standard wound care for diabetic foot ulcers: a protocol for a systematic review with meta-analysis and trial sequential analysis

“…85 86 The method has previously been applied by our group in systematic reviews with meta-analysis on a wide range of healthcare topics. [87][88][89][90][91][92][93][94] A PRISMA-P checklist file is attached (online supplementary additional file 1).…”

“…In case that only changes from baseline scores were reported, then we will analyse the results together with follow-up scores. 88 If SDs were not reported we will use trial data to calculate the SDs, whenever possible. We will only use intention-to-treat data when the randomised trial contains and report such data.…”

Complications and Pharmacologic Interventions of Invasive Positive Pressure Ventilation During Critical Illness

“…[77][78][79] Trials are actively being conducted to reevaluate the nearly universal role of SUP. 80,81 For the pharmacist, agent selection should be tailored to patient specific factors (ie, history of gastrointestinal bleeding necessitating PPI use, home agent use, etc) and should aim to minimize potential harms of SUP. Furthermore, inappropriate continuation of SUP once a patient is liberated from IPPV in both the hospital and outpatient settings is a rampant issue.…”