A variety of interventions that were deemed effective based on clinical trials were not useful for treating patients hospitalized with pneumonia and were associated with adverse events, according to a study published in JAMA Internal Medicine.
“In recent years, data from randomized clinical trials (RCTs) have emerged demonstrating improved patient and health-system outcomes in community-acquired pneumonia for several interventions,” Melanie Lloyd, MPhtySt, of the department of physiotherapy, Western Health, at the University of Melbourne in Australia, and colleagues wrote. “However, we observe a wide gap between evidence and actual clinical practice in which many of these interventions are poorly implemented or have not been incorporated into guidelines despite high-level supportive evidence (eg, corticosteroids). A reluctance to do so may reflect challenges in applying findings of RCT data to real-world settings because of concerns regarding the representativeness, generalizability, and external validity of existing clinical trial data.”
To evaluate the effectiveness of evidence-supported treatments when implemented under routine health care conditions, researchers conducted a double-blind, stepped-wedge, cluster-RCT at two tertiary hospitals between August 2016 and October 2017.
A total of 816 patients (mean age, 76 years) with community-acquired pneumonia were assigned to either the intervention group or the control group.
The intervention consisted of 50 mg of prednisolone acetate or equivalent for 7 days, a switch from parenteral to oral antibiotics, sitting out of bed for more than 20 minutes on the day of admission with daily progressive mobilization, routine screening for malnutrition and targeted nutritional therapy
The primary outcome of the study was hospital length of stay (LOS). Secondary outcomes included mortality, readmission and intervention-associated adverse events (specifically, gastrointestinal bleeding and hyperglycemia).
A variety of interventions that were deemed effective based on clinical trials were not useful for treating patients hospitalized with pneumonia and were associated with adverse events.
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Researchers found that length of stay was similar between the two groups (LOS > 3 days for 30.8% in usual care vs. 34.6% in intervention; unadjusted geometric mean ratio = 0.95; 95% CI, 0.78-1.16).
Similarly, no significant differences were observed between usual care and intervention for mortality at 30 (10.4% vs. 11%) or 90 days (15.2% vs. 17.2%) or readmission.
As for adverse events, researchers found that 0.7% of the control group developed gastrointestinal bleeding compared with 2.2% of those receiving the intervention.
“This study underscores a groundswell of opinion arguing that interventions showing efficacy in RCTs should also undergo real-world evaluation prior to integration into clinical practice guidelines and pathways,” the researchers wrote. “Our novel implementation research design using a stepped-wedged RCT method provides a precedent and template for future evaluations that address this need. The risks and lack of effectiveness of the bundle of care demonstrated in this study strongly suggest that it is not useful as a means of improving the care of patients with community-acquired pneumonia.” – by Melissa J. Webb
Disclosures: Lloyd reports receiving personal fees from Australian Government Research Training Scheme and receiving grants from HCF Research Foundation. Please see the study for all other authors’ relevant financial disclosures.