The devil is in the details- overstating the results of the effects of corticosteroids in patients with pneumonia

This blog post will tie in nicely with what I blogged on earlier today about composite endpoints. Read that post first before reading this.

Today I received my e-table of contents from JAMA and read a study on the of Effect of Corticosteroids on Treatment Failure Among Hospitalized Patients With Severe Community-Acquired Pneumonia and High Inflammatory Response. The primary outcome of the study was “treatment failure (composite outcome of early treatment failure defined as [1] clinical deterioration indicated by development of shock, [2] need for invasive mechanical ventilation not present at baseline, or [3] death within 72 hours of treatment; or composite outcome of late treatment failure defined as [1] radiographic progression, [2] persistence of severe respiratory failure, [3] development of shock, [4] need for invasive mechanical ventilation not present at baseline, or [5] death between 72 hours and 120 hours after treatment initiation; or both early and late treatment failure).”

The authors make a bold statement:

The results demonstrated that the acute administration of methylprednisolone was associated with less treatment failure…”

I find this statement (from the 1st sentence in the discussion section) to be a vast overstatement of what they in fact found in this study.  Examine the table below (I trimmed out the per-protocol analysis results) and see just what was actually reduced by steroids.

From JAMA 2015;313(7):677-686

From JAMA 2015;313(7):677-686

Steroids had no effect on “early treatment failure”. They significantly reduced “late treatment failure” but this was all driven by one outcome. The only thing steroids did was reduce radiographic progression. They didn’t help any other outcomes of this large composite but yet the authors make this sweeping statement of steroids being associated with less treatment failure. This demonstrates the importance of looking at the individual components of the composite and not just focusing on the overall composite result.

It also demonstrates why I don’t like to read the discussion section of a paper nor the conclusions from an abstract- you will be misled. The reviewers and editors should have toned down these conclusions as they are a gross overstatement of what was actually found.

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