Effectiveness of a Bundled Intervention Including Adjunctive Corticosteroids on Outcomes of Hospitalized Patients With Community-Acquired Pneumonia

Abstract

for the Improving Evidence-Based Treatment Gaps and Outcomes in Community-Acquired Pneumonia (IMPROVE-GAP) Implementation Team at Western Health IMPORTANCE Community-acquired pneumonia remains a leading cause of hospitalization, mortality, and health care costs worldwide. Randomized clinical trials support the use of adjunctive corticosteroids, early progressive mobilization, antibiotic switching rules, and dietary interventions in improving outcomes. However, it is uncertain whether implementing these interventions will translate into effectiveness under routine health care conditions. OBJECTIVE To evaluate the effectiveness of a bundle of evidence-supported treatments under conditions of routine care in a representative population hospitalized for community-acquired pneumonia. DESIGN, SETTING, AND PARTICIPANTSA double-blind, stepped-wedge, cluster-randomized clinical trial with 90-day follow-up was conducted between August 1, 2016, and October 29, 2017, in the general internal medicine service at 2 tertiary hospitals in Melbourne, Australia, among a consecutive sample of patients with community-acquired pneumonia. The primary analysis and preparation of results took place between May 14 and November 25, 2018.INTERVENTIONS Treating clinical teams were advised to prescribe prednisolone acetate, 50 mg/d, for 7 days (in the absence of any contraindication) and de-escalate from parenteral to oral antibiotics according to standardized criteria. Algorithm-guided early mobilization and malnutrition screening and treatment were also implemented. MAIN OUTCOMES AND MEASURESHospital length of stay, mortality, readmission, and intervention-associated adverse events (eg, gastrointestinal bleeding and hyperglycemia).RESULTS A total of 917 patients were screened, and 816 (351 women and 465 men; mean [SD] age, 76 [13] years) were included in the intention-to-treat analysis, with 401 patients receiving the intervention and 415 patients in the control group. An unadjusted geometric mean ratio of 0.95 (95% CI, 0.78-1.16) was observed for the difference in length of stay (days) between the intervention and control groups. Similarly, no significant differences were observed for the secondary outcomes of mortality and readmission, and the results remained unchanged after further adjustment for sex and age. The study reported higher proportions of gastrointestinal bleeding in the intervention group (9 [2.2%]) compared with the controls (3 [0.7%]), with an unadjusted estimated difference in mean proportions of 0.008 (95% CI, 0.005-0.010). CONCLUSIONS AND RELEVANCEThis bundled intervention including adjunctive corticosteroids demonstrated no evidence of effectiveness and resulted in a higher incidence of gastrointestinal bleeding. Efficacy of individual interventions demonstrated in clinical trials may not necessarily translate into effectiveness when implemented in combination and may even result in net harm.TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02835040

Improved treatment of community-acquired pneumonia through tailored interventions: Results from a controlled, multicentre quality improvement project

“…The finding that only 41% of all CAP patients received assessments and treatments conforming to established guidelines might seem concerning. However, given that the care bundle relies on four independent elements, we believe that this result still is remarkable when compared to other studies on CAP care bundles reporting compliance rates of 20-29% [16,23,42]. LRTS collection can be challenging to improve in CAP, but it is regarded as crucial in the Nordics for potentially altering the often narrow-spectred empiric antibiotic treatment [4,30,31,43].…”

“…Few studies have explored the effect of care bundles on the quality of care for CAP and those were not conclusive. One recently published study did not identify any outcome benefits of implementing a care bundle for CAP patients [23]. However, this may be due to the study's small size and the inclusion of heterogeneous and controversial elements of CAP care, such as corticosteroid treatment [23].…”

“…One recently published study did not identify any outcome benefits of implementing a care bundle for CAP patients [23]. However, this may be due to the study's small size and the inclusion of heterogeneous and controversial elements of CAP care, such as corticosteroid treatment [23]. Two larger studies with 2819 [24] and 23315 [25] patients, respectively, reported that the implementation of a CAP care bundle led to a higher proportion of patients receiving antibiotics within 4 hours as well as a reduction in mortality rate.…”

Platelets and Their Role in the Pathogenesis of Cardiovascular Events in Patients With Community-Acquired Pneumonia

“…However, others have recommended caution with regard to the routine use of CS other than perhaps for patients with severe CAP requiring ICU admission, citing the fact that many of the studies of CS use in CAP are relatively small, have some methodological issues, and the potential harmful effects need to be more fully elucidated; hence, while they concede that CS may have benefit in a small subset of cases with severe CAP, these cases have not yet been adequately identified ( 164 ). Other study results suggest that it is not only important to demonstrate benefits in stringently controlled randomized controlled trials, but also in the real world situation ( 165 ). It is hoped that current and ongoing studies of CS use in patients with CAP will clarify some of these issues ( 164 , 166 ).…”

Twenty‐five years of Respirology: Advances in respiratory infections and tuberculosis

“…8 A bundled intervention including adjunctive systemic corticosteroids in the form of prednisolone acetate 50 mg/day for 7 days for patients with CAP demonstrated no evidence of effectiveness (with regard to hospital LOS, mortality and readmission) and resulted in a higher incidence of gastrointestinal bleeding in comparison with controls who did not receive systemic corticosteroids (9 (2.2%) vs 3 (0.7%)). 9 The updated guideline of the American Thoracic Society and Infectious Diseases Society of America has recommended not to prescribe systemic corticosteroids routinely for CAP except for those with refractory septic shock. 10 Personal protective equipment is important for healthcare workers treating patients with acute respiratory infections.…”