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DCoE Webinar Rewind:

Review Clinical Study Methods before You Accept Results, Expert Says

Doctor conducting session using telehealth technology
U.S. Navy photo by Douglas Stutz

As new medical treatment approaches and platforms come along, providers should check whether the evidence offered to support the new approaches actually proves what it claims. This is especially important when it comes to non-inferiority studies, which try to show that a new approach is no worse than the old one, said Derek Smolenski, an epidemiologist and quantitative methodologist for the National Center for Telehealth & Technology.

A non-inferiority study is conducted to prove, or disprove, that a new form of treatment is no worse than the current standard of treatment, or if it is, that it is not unacceptably worse. Because this type of study is often used to compare new approaches like video conferencing and electronic self-help resources to current methods, a provider’s ability to critically analyze the findings of such studies is paramount, Smolenski said in a webinar hosted last month by the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury. Non-inferiority studies can be useful to determine the efficiency of clinical practices, but errors in study methodology may invalidate them, he said.

“It is my hope for all of you that you can look at an article objectively, review what they did, see if there is evidence to support it, and make a conclusion,” Smolenski said.

Provider Caution

Smolenski gave a brief appraisal of several non-inferiority studies that were not properly structured, despite the labels researchers gave them.

One key to a good study is to decide what variation in quality is acceptable at the outset of the trial. This margin determines whether a new method involves an acceptable drop in the quality of treatment when compared against the benefits it may offer. Two other criteria that must be met for a valid study:

  • The new method must be compared to the best available treatment standard.
  • The study group must be large enough to support a statistically meaningful result.

The full webinar, “Technological Updates in the Treatment of Mental Health Conditions”, can be found on the DCoE website, along with resources for providers interested in learning more about non-inferiority studies.

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This page was last updated on: September 14, 2017.