SynthesisJournal of patient safety2026
Effectiveness and Safety of Continuous Quality Improvement and Failure Mode and Effect Analysis for Preventing Adverse Events in Hospitalized Patients: A Systematic Review of Complex Interventions.
Synthesis in Journal of patient safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study aimed to assess the effectiveness and safety of continuous quality improvement (CQI) and failure mode and effect analysis (FMEA) in preventing adverse events (AEs) in hospitalized patients.
methodsThis systematic review included randomized controlled trials, quasiexperiments, and time-series studies that used CQI or FMEA in hospital processes and evaluated AEs. Studies published in English, Portuguese, and Spanish from September 2010 to September 2024 were searched in the MEDLINE/PubMed, Embase/Elsevier, CENTRAL, and LILACS databases. Two authors independently applied the study selection criteria and extracted data on methodology, patient population, and the effect of CQI or FMEA on AEs. We evaluated the risk of bias for before and after (B&A) studies with a control group and time-series studies, critically appraised the quality of B&A studies without a control group, determined causal inference strength for quasiexperiments, and reported quality for CQI studies. Moreover, we presented a narrative synthesis of results along with an assessment of evidence certainty determined using the GRADE approach. The register code at PROSPERO is CRD42021254216.
resultsOf the 20,433 titles, 107 were subjected to full-text review, and 59 studies were analyzed. Forty-nine studies (83%) used CQI, whereas 10 used FMEA. The most studied category was related to catheters. Although the analyzed studies predominantly reported a reduction in AEs, evidence certainty was very low for 93% of the intervened processes.
conclusionsCQI and FMEA studies revealed a potential reduction of AEs in various processes. However, these results should be cautiously applied to clinical practice due to very low evidence certainty. Moreover, further research with improved control of confounding factors is needed.
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