Notepad: Interesting Methodology Documents

 In THAMBISETTY, STAT, ADU

he says we should be more proactive about detecting public health harms in ADU family drugs.   Should there even be a REMS?  If not, how do we manage harms like ARIA, plus the high incidence of random events in the very old.

https://www.statnews.com/2023/11/28/lecanemab-leqembi-aducanumab-donanemab-side-effects-aria-brain/

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On the topic of HARMS, see position paper on measuring harms, which come in randomly at unknown rates, in RCTs.   JUNQUEIRA,  J Clin Epi 2023.

https://pubmed.ncbi.nlm.nih.gov/37100738/

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials

Daniela R Junqueira 1, 

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On the topic of imperfect gold standards, 2019 PLOS ONE

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223832

Diagnostic test evaluation methodology: A systematic review of methods employed to evaluate diagnostic tests in the absence of gold standard – An update

Chinyereugo M. Umemneku Chikere 

At FDA MCED meeting 11/29, made the point that you can only show Cologuard is better than FIT, by having a 3rd test (colonoscopy) better than both.  The only sure paradigm to compare 2 tests, is to have 3 tests (!).

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Excellent 2023 paper on Dec impact theory - review.  

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10004522/

PLoS One. 2023; 18(3): e0280582.

Published online 2023 Mar 10. doi: 10.1371/journal.pone.0280582

PMCID: PMC10004522

PMID: 36897859

Decision impact studies, evidence of clinical utility for genomic assays in cancer: A scoping review

Gillian Parker 2023

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FDA MCED - Discussion of spec sens and spectrum shift - something talked about since 1960s.

Test research vs diagnostic reserach "classic"

https://pubmed.ncbi.nlm.nih.gov/14981027/

Comparative Study Clin Chem

. 2004 Mar;50(3):473-6. doi: 10.1373/clinchem.2003.024752.

Test research versus diagnostic research

Karel G M Moons 1, Cornee J Biesheuvel, Diederick E Grobbee

Affiliations expand

PMID: 14981027 DOI: 10.1373/clinchem.2003.024752