October 15, 2012 — On October 10th, 2012, “The Kaiser Health News” published the article, “Study: CMS Penalties Don’t Change Hospital-Acquired Infection Rates” (by: J. Appleby).

This article’s headline reads: “A Medicare payment policy designed to push hospitals to cut their infection rates has had no effect in reducing two types of preventable infections among patients in intensive care units, researchers say in a study out Wednesday in the New England Journal of Medicine.”

A reply

If the majority of this study’s central-line infection rate’s numerator (number of infections) and denominator (patient or central line days) – these infection data, which were provided by the almost 400 participating hospitals, were the basis for this study’s conclusions – were not independently audited and validated for accuracy and completeness, might not these data be unreliable, inaccurate, and incomplete?

Might not, therefore, the authors having found “no evidence that the 2008 Centers for Medicare and Medicaid Services policy to reduce payments for central catheter–associated bloodstream infections and catheter-associated urinary tract infections had any measurable effect on infection rates in U.S. hospitals” be a conclusion that is in question?

Could not the “actual” infection rate (which is different from and, due to many types of well-known biases, may be greater than the “reported” infection rate), or even the transmission rate of infectious agents (which, incidentally, is crucial although is not ordinarily studied and can be masked by antibiotics and not be detected), have ironically risen by the study’s end in 2011? (The study by Lee et al. does not exclude this possibility and, in fact, appears to subtlety support it.)

Are not the conclusions of any retrospective or prospective cohort (non-randomized, not controlled) study, like Lee et al.’s, that analyzes trends in infection rates only as sound as their associated infection data are demonstrated to be reliable and valid?

The important topic of data validation is not discussed in Lee et al.’s study. Nevertheless, it can be appropriate argued that failure to place emphasis on and to verify the accuracy and completeness of infection data renders of limited scientific significance any conclusions about the quality and safety of health care – or, too, about the impact of an intervention, or bundle of practices, or federal program, effort, or policy – that are associated with or based on these potentially erroneous infection data.

Read more about this topic in Dr. Muscarella’s peer-reviewed article “Assessment of the Reported Effectiveness of Five Different Quality-Improvement Initiatives for the Prevention of Central Line-Associated Bloodstream Infections in Intensive Care Units.”



Article by: Lawrence F Muscarella, PhD. Posted on October 15, 2012; updated on July 30, 2015. LFM Healthcare Solutions, LLC Copyright 2016. LFM Healthcare Solutions, LLC.  All rights reserved.

Lawrence F Muscarella PhD is the owner of LFM Healthcare Solutions, LLC, a Pennsylvania-based quality improvement and consulting company that provides safety services for hospitals, manufacturers and the publicEmail Dr. Muscarella for more details.

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