The effect of pressure injury prevention care bundles on pressure injuries in hospital patients: A complex intervention systematic review and meta-analysis

Background: Numerous interventions for pressure injury prevention have been developed, including care bundles. Objective: To systematically review the effectiveness of pressure injury prevention care bundles on pressure injury prevalence, incidence, and hospital-acquired pressure injury rate in hospitalised patients. Data sources: The Medical Literature Analysis and Retrieval System Online (via PubMed), the Cumulative Index to Nursing and Allied Health Literature, EMBASE, Scopus, the Cochrane Library and two registries were searched (from 2009 to September 2023). Study eligibility criteria: Randomised controlled trials and non-randomised studies with a comparison group published in English after 2008 were included. Studies reporting on the frequency of pressure injuries where the number of patients was not the numerator or denominator, or where the denominator was not reported, and single subgroups of hospitalised patients were excluded. Educational programmes targeting healthcare professionals and bundles targeting specific types of pressure injuries were excluded. Participants and interventions: Bundles with >= 3 components directed towards patients and implemented in >= 2 hospital services were included. Study appraisal and synthesis methods: Screening, data extraction and risk of bias assessments were undertaken independently by two researchers. Random effects meta-analyses were conducted. The certainty of the body of evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation. Results: Nine studies (seven non-randomised with historical controls; two randomised) conducted in eight countries were included. There were four to eight bundle components; most were core, and only a few were discretionary. Various strategies were used prior to (six studies), during (five studies) and after (two studies) implementation to embed the bundles. The pooled risk ratio for pressure injury prevalence (five nonrandomised studies) was 0.55 (95 % confidence intervals 0.29-1.03), and for hospital-acquired pressure injury rate (five non-randomised studies) it was 0.31 (95 % confidence intervals 0.12-0.83). All non-randomised studies were at high risk of bias, with very low certainty of evidence. In the two randomised studies, the care bundles had non-significant effects on hospital-acquired pressure injury incidence density, but data could not be pooled. Conclusions and implications of key findings: Whilst some studies showed decreases in pressure injuries, this evidence was very low certainty. The potential benefits of adding emerging evidence-based components to bundles should be considered. Future effectiveness studies should include contemporaneous controls and the development of a comprehensive, theory and evidence -informed implementation plan. Systematic review registration number: PROSPERO CRD42023423058. Tweetable abstract: Pressure injury prevention care bundles decrease hospital -acquired pressure injuries, but the certainty of this evidence is very low. (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).