Effectiveness and Safety of Continuous Quality Improvement and Failure Mode and Effect Analysis for Preventing...

This 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.

This 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.

Of 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.

CQI 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.