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Phenotype submission - LEGEND-T2DM outcome definitions

Contributor name: LEGEND-T2DM team (individuals in order of authorship in the BMJ Open publication, all authors contributed to these definitions) Rohan Khera Martijn Schuemie @schuemie Yuan Lu @Yuan_Lu Anna Ostropolets @aostropolets RuiJun Chun @rchen George Hripcsak @hripcsa , Patrick Ryan @Patrick_Ryan Harlan Krumholz Marc Suchard @msuchard )

Cohort Definition Names:
In the LEGEND-T2DM study, we conducted population-level effect estimation studies for the comparative effectiveness of diabetes treatments, using cardiovascular outcomes that were related to intended effects as well as labeled adverse events. These outcome list included:

  • 3-point MACE
  • 4-point MACE
  • Acute myocardial infarction
  • Acute renal failure
  • Glycemic control
  • Hospitalization with heart failure
  • Measured renal dysfunction
  • Revascularization
  • Stroke
  • Sudden cardiac death
  • Abnormal weight gain
  • Abnormal weight loss
  • Acute pancreatitis
  • All-cause mortality
  • Bladder cancer
  • Bone fracture
  • Breast cancer
  • Diabetic ketoacidosis
  • Diarrhea
  • Genitourinary infection
  • Hyperkalemia
  • Hypoglycemia
  • Hypotension
  • Joint pain
  • Lower extremity amputation
  • Nausea
  • Peripheral edema
  • Photosensitivity
  • Renal cancer
  • Thyroid tumor
  • Venous thromboembolism
  • Vomiting

Logic and description:
The full list of outcomes with descriptions are described in the LEGEND-T2DM Git repo as a csv file here: https://github.com/ohdsi-studies/LegendT2dm/blob/master/inst/settings/OutcomesOfInterest.csv

All JSON corresponding to these cohorts are available here: https://github.com/ohdsi-studies/LegendT2dm/tree/master/inst/cohorts/outcome

Note that some of the LEGEND-T2DM definitions were previously used in LEGEND-HTN and are therefore redundant and do not need to be entered into the library again.

Recommended study application: Outcome

Assertion statement: This cohort definition was executed on at least one real person-level observational health data source and resulted in a cohort with at least 1 person.

Citations: These outcome phenotypes have been used in one peer-review publication thusfar, which is the protocol that includes the full outcome cohort definitions as an appendix:

Khera R, Schuemie MJ, Lu Y, Ostropolets A, Chen R, Hripcsak G, Ryan PB, Krumholz HM, Suchard MA. Large-scale evidence generation and evaluation across a network of databases for type 2 diabetes mellitus (LEGEND-T2DM): a protocol for a series of multinational, real-world comparative cardiovascular effectiveness and safety studies. BMJ Open. 2022 Jun 9;12(6):e057977. doi: 10.1136/bmjopen-2021-057977. PMID: 35680274; PMCID: PMC9185490. https://bmjopen.bmj.com/content/12/6/e057977.info