Wednesday, January 18, 2017

Results May Differ, Even in Evidence-Based Medicine (Two New Examples)

One of the hallmarks of Evidence Based Medicine is the standardization of evidence review, with the aim of providing a more objective process likely to lead to the same results in different hands.

But it's not always the case.   Two examples in the last few weeks are a differing assessment of breast cancer prognostics from a major HTA agency, and a differing assessment of diabetes prevention testing between the USPSTF and an evidence review in the BMJ.  Discussion after the break.

Breast Cancer - US vs Germany

US guidelines such as NCCN and ASCO are evidence-based, rigorous, and endorse use of molecular prognostic tests to assist in the management of breast cancer, especially the decision for adjuvant chemotherapy.   For the ASCO guideline in April 2016, here.

Here's the contrasting report.  This January, Genomeweb covered a negative German Health Technology Assessment of breast cancer prognostic tests, released in early December.  In an extensive (multi-hundred-page) review of breast cancer prognostics by IQWiG, the German equivalent of AHRQ, they found "little definite evidence" for benefit of these tests.   (I find this remarkable).  

The Genomeweb article by Andrew Han is here.

The IQWiG press release is here (German), and the IQWiG home page for the topic is here (multiple PDFs, German.)  Note that the German date 05.12.2016 is December 5, 2016.
  • IQWIG in English.   After light editing, I've clipped the Google Translate of the IQWiG German press release: here.  (I can read German, but slowly.)  
  • Two German news/views articles, with English translation: 
    • Original German trade press on the IQWIG report, here.   Google English: here.
    • Original German general news article in the Berlin-based TagesSpeigel, here.   Google English: here.
  • Note that the December 2016 review focuses on MINDACT, because it is an supplement or update to a prior comprehensive review (also negative) in late 2015.
Agendia has disputed the German finding (English press releases; herehere). 

Diabetes Prevention - USPSTF and CDC and CMS vs. BMJ

Based on a wide range of national and international studies, the US has ramped up efforts at diabetes prevention through validated intervention programs.   

The USPSTF recommends screening for prediabetic status, most recently updated in February 2016 (Medscape, here; JAMA, here.)   USPSTF reviews are systematic and very rigorous.

The CDC has a website for its credentialing program for diabetes prevention entities (here).   CMS is launching a national prevention benefit for Medicare beneficiaries, based on favorable results of a two-year pilot (here).     

Here's the contrasting report.  As early as 2015, the BMJ questioned the NHS diabetes prevention program (here).  A full-length and relatively negative review appeared in the BMJ on January 4, 2017, Barry et al., here.  For a trade journal article, see Medpage, here.  


Among the annual circa $1B in prevention funding created by the 2010 ACA, HHS has recently spent $72M/year in a designated diabetes prevention program via CDC.   The 21st Century Cures legislation cut a total of several billion dollars out of the Prevention programs (over 10 years), so the impact on the CDC diabetes program will depend on implementation of those cuts in FY2018 and forward.  

German advertisement for Oncotype DX, here. (PDF).


For a slightly earlier, November 2016 Genomeweb article on German genomics policy, here.