Medical Tests
Inaccuracies, Risks and the Public's Health

Summary

MEDICAL TESTS: Inaccuracies, Risks and the Public’s Health
Presented in Collaboration with STAT
Moderator: Sharon Begley, Senior Science Writer, STAT

Without question, medical testing has saved lives and bettered patient care. But what happens when tests are inaccurate or unnecessary? The U.S. Food and Drug Administration (FDA) recently raised alarms about a growing class of tests designed and used in single laboratories, which are far less subject to regulatory enforcement than commercial test kits sold to multiple labs. The agency reviewed 20 case studies involving lab-developed tests (LDTs) and found evidence of patients at risk for medically unnecessary procedures, including mastectomies, or for potentially inappropriate therapies, including cancer treatments. Some tests may fail to detect a condition, while others may erroneously point to a non-existent problem. The medical costs are significant. The Obama administration is calling for a new regulatory framework as well.

LDTs are not the only source of concern. A 2013 meta-analysis involving commonly ordered lab tests found that 30 percent, on average, were probably unnecessary and, conversely, a similar number should have been ordered and were not.

Scrutiny of lab testing is intensifying as the medical community grapples to address diagnostic errors. This year, the Institute of Medicine issued a study, Improving Diagnosis in Health Care, as a continuation of an earlier series of patient safety reports. Pointing to many factors in diagnostic errors, the recent report states that “most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.”

This Forum examined the role of medical tests in health care, looking both at their considerable benefits and risks and asking how to ensure their accuracy, safety and reliability.

Brief Video Highlights

Image Credit: Getty Images/dra_schwartz

  • The Forum Moderator

    Welcome all! We’ll start our live webcast in about 10 minutes.

  • The Forum Moderator

    We’ll being in a few minutes.

  • The Forum Moderator

    We have begun. Thank you all for joining us.

  • The Forum Moderator

    This event is presented in collaboration with STAT and our moderator today, Sharon Begley, is a senior science writer at STAT.

  • The Forum Moderator

    This clip is courtesy of The New England Center for Investigative Reporting.

  • The Forum Moderator

    The FDA recently issued a report about “laboratory-developed tests” or LDTs. The report featured 20 case studies and can be read at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf

  • The Forum Moderator

    An executive summary of that FDA report is available here: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm

  • The Forum Moderator

    Dr. Arnaout was senior author on a meta-analysis involving blood tests. That paper is available here: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0078962

  • The Forum Moderator

    We will have a brief Q&A at the end of this discussion. You can post your questions for the panelists here. Or email them to theforum@hsph.harvard.edu.

  • Molly

    do you have the study that he’s talking about? with tests that are unnecessary or not ordered?

  • The Forum Moderator

    The Institute of Medicine report on Improving Diagnosis in Health Care is here: http://www.nap.edu/read/21794/chapter/1

  • The Forum Moderator

    Have a question for the panelists? Post it here or email it to theforum@hsph.harvard.edu.

  • The Forum Moderator

    We will be posting this video on demand on this site next week. We also will post it on YouTube and iTunesU.

  • Stephanie Hixon

    How do the panel members feel about ‘direct access testing’? That is, testing that is available to the public without a physician’s prescription? Such as routine testing that Ramy had mentioned being underutilized. Possibly due to insurer’s regulation as we’ve experienced in our GPs offices? How much control do insurance companies actually have in testing processes?

    • The Forum Moderator

      Thanks Stephanie.

  • Omar Yaghi

    Question to Lucian Leape: Don’t you think if the electronic computer system pops up asking How did you think about that particular test will increase the defensive medicine approach? How would you go about the issue?

    • The Forum Moderator

      Thank you.

  • The Forum Moderator

    Just a reminder that we will be post this video on demand on this site next week. We also will post it on YouTube and iTunesU. And the audio will be on SoundCloud and iTunes, too.

  • The Forum Moderator

    Our event will be ending soon. We thank you all for joining us today.

  • The Forum Moderator

    Join us again next week when we will have a Forum called Climate Change: Health and Disease Threats on Wednesday, December 16, from 12:30-1:30pm ET. http://theforum.sph.harvard.edu/events/climate-change/

  • The Forum Moderator

    Thank you all for joining us today!

  • when will next discussion starts ?