Real World Evidence Study Adds some Color to Randomized Controlled Trial Findings in Real-Life

group of students working at the laboratory

The University of Melbourne, Australia led a study showing that a variety of interventions that were conclusively effective based on randomized controlled trials as it turns out in the real world are not useful for treating patients hospitalized with pneumonia and were associated with adverse events.

The RCT

The recent study results, published in JAMA Internal Medicine, was based on an effort to evaluate the effectiveness of evidence-supported treatments when implemented under routine health care conditions. The investigative team conducted a double-blind, stepped-wedge, cluster RCT at two tertiary hospitals back between 2016 and 207.

The team assessed 816 patients with community-acquired pneumonia; they were assigned to either the intervention group or the control group reported Healio

Healio reported that the intervention consisted of 50 mg of prednisolone acetate or equivalent for 7 days, a switch from parental to oral antibiotics, sitting out of bed for more than 20 minutes on the day of admission with daily progressive mobilization routine screening of malnutrition and targeted nutritional therapy.

The Results

With a primary outcome of the study being hospital length of stay (LOS), secondary outcomes included mortality, readmission and intervention-associated events (specifically, gastrointestinal bleeding and hyperglycemia).

The Real World Evidence Post Study

Melanie Lloyd, MPhtySt, of University of Melbourne, Department of physiotherapy, Western Health reported: “In recent years, data from randomized clinical trials (RCT) have emerged demonstrating improved patient and health-system outcomes in community-acquired pneumonia for several interventions.” Lloyd continued “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 these guidelines despite high-level supportive evidence (e.g. corticosteroids). A reluctance to do so many 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.”

RWE Should Compliment Review RCT

It was noted “this study underscores a groundswell of opinion arguing that interventions showing the efficacy of RCT should also undergo real-world evaluation prior to integration into clinical practice guidelines and pathways,” wrote the Australian researchers.

Lead Research/Investigator

Melanie Lloyd, MPhtySt, of the University of Melbourne, Department of physiotherapy, Western Health