Documents/PhenotypeDefinitions.md

In OHDSI/Legend: Large-Scale Evidence Generation and Evaluation in a Network of Databases

Definition process

We originally identified outcomes for LEGEND from clinical trial endpoints from clinical guidelines and systematic reviews. We augmented these with adverse events from US structured product labels of hypertension drugs (https://dailymed.nlm.nih.gov/dailymed/). For each outcome, we developed an operational phenotype definition to determine if observational data could in fact support evaluation of the outcome. We used the same approach to design, implement, and evaluate all phenotypes. Specifically, we conducted a PubMed literature review to identify prior observational studies that used the phenotype as an outcome, looking especially for studies where source record verification or other approaches validated the outcome. In addition, we reviewed eMERGE PheKB phenotype entries (https://phekb.org/phenotypes). Clinical guidelines and systematic review of clinical trials of hypertension treatments informed our clinical definitions of cardiovascular outcomes (1 2 3). Where possible, conceptsets originated with published codelists (e.g. ICD-9-CM and ICD-10). We augmented these with lexical search and semantic exploration of the OHDSI standardized vocabularies. A clinical adjudicator then reviewed the cohort definitions and associated conceptsets. We developed concept definitions using ATLAS, the OHDSI open-source platform (https://github.com/OHDSI/atlas). We initially executed these definitions across 7 databases (CCAE, MDCR, MDCD, Optum, Panther, JMDC, IMS Germany) to identify qualifying patients. Because the databases used in this study do not all consistently contain laboratory values, diagnosis records alone identified outcomes involving electrolyte imbalance (hypokalemia, hypomagnesemia, hyponatremia). To assess consistency across data sources as well as general clinical reasonableness, we utilized these cohorts to characterize outcome incidence, stratifying by age decile, gender, and index year. We did not perform source record verification or other validation methods.

Phenotype Logical description Supporting references Abdominal pain Abdominal pain condition record of any type; successive records with > 90 day gap are considered independent episodes 4 5 6 Abnormal weight gain Abnormal weight gain record of any type; successive records with > 90 day gap are considered independent episodes; note, weight measurements not used 7 Abnormal weight loss Abnormal weight loss record of any type; successive records with > 90 day gap are considered independent episodes; note, weight measurements not used 8 Acute myocardial infarction Acute myocardial infarction condition record during an inpatient or ER visit; successive records with > 180 day gap are considered independent episodes 9 10 11 12 13 14 Acute pancreatitis Acute pancreatitis condition record during an inpatient or ER visit; successive records with >30 day gap are considered independent episodes 15 16 17 18 Acute renal failure A diagnosis of acute renal failure in an inpatient or ER setting; must be at least 30d between inpatient/ER visits to be considered separate episodes 19 20 21 22 23 24 25 26 All-cause mortality Death record of any type 12 27 28 Anaphylactoid reaction Anaphylactoid reaction condition record during an inpatient or ER visit; successive records with >7 day gap are considered independent episodes 29 30 Anemia The first condition record of anemia 31 32 33 Angioedema Angioedema condition record during an inpatient or ER visit; successive records with >7 day gap are considered independent episodes 29 34 Anxiety The first condition record of anxiety, which is followed by another anxiety condition record or a drug used to treat anxiety 35 36 37 38 Bradycardia The first condition record of bradycardia, which is followed by another bradycardia condition record 39 40 Cardiac arrhythmia The first condition record of cardiac arrhythmia, which is followed by another cardiac arrhythmia condition record, at least two drug records for a drug used to treat arrhythmias, or a procedure to treat arrhythmias 41 42 43 44 45 46 47 Cardiovascular disease A condition record of ischemic stroke, hemorrhagic stroke, heart failure, acute myocardial infarction or sudden cardiac death during an inpatient or ER visit; successive records with > 180 day gap are considered independent episodes 9 10 11 12 13 14 41 Cardiovascular-related mortality Death record with at least 1 cardiovascular-related condition record (myocardial infarction, ischemic stroke, intracranial hemorrhage, sudden cardiac death, hospitalization for heart failure) in 30 days prior to death 12 Chest pain or angina The first condition record of chest pain or angina 48 Chronic kidney disease The first condition record of chronic kidney disease, which is followed by either another chronic kidney disease condition record or a dialysis procedure or observation 21 49 50 51 52 53 54 55 56 Cough Cough condition record of any type; successive records with > 90 day gap are considered independent episodes 57 58 59 Decreased libido The first condition record of decreased libido 60 Dementia The first condition record of dementia 61 62 63 64 65 66 67 68 Depression The first condition record of depression, which is followed by another depression condition record, at least two drugs used to treat depression without another indication, or two psychotherapy procedures 36 37 67 69 70 71 72 Diarrhea Diarrhea condition record of any type; successive records with > 30 day gap are considered independent episodes 73 74 75 End stage renal disease End stage renal disease (ESRD) is defined by at least one diagnosis in any setting, followed by at least one additional diagnosis or a dialysis-related procedure within 90 days 18 54 76 Fall Fall condition record of any type; successive records with > 180 day gap are considered independent episodes 77 78 79 Gastrointestinal bleeding Gastrointestinal hemorrhage condition record during an inpatient or ER visit; successive records with > 30 day gap are considered independent episodes 4 13 80 81 82 83 84 Gout The first condition record of gout 85 86 87 88 Headache Headache condition record of any type; successive records with > 30 day gap are considered independent episodes 89 90 Heart failure The first condition record of heart failure, which is followed by at least 1 heart failure condition record in the following year 10 91 92 93 94 95 96 97 98 99 100 Hemorrhagic stroke Intracranial, cerebral or subarachnoid hemorrhage condition record during an inpatient or ER visit; successive records with > 180 day gap are considered independent episodes 101 102 103 104 105 Hepatic failure The first condition record of hepatic failure, necrosis, or coma 19 106 107 108 109 110 111 112 113 Hospitalization for heart failure Inpatient or ER visits with heart failure condition record; all qualifying inpatient visits occurring > 7 days apart are considered independent episodes 93 98 99 114 115 Hyperkalemia Condition record for hyperkalemia or potassium measurements > 5.6 mmol/L; successive records with >90 day gap are considered independent episodes 116 117 118 Hypokalemia Hypokalemia condition record of any type; successive records with > 90 day gap are considered independent episodes 119 Hypomagnesemia Hypomagnesemia condition record of any type; successive records with > 90 day gap are considered independent episodes 120 121 Hyponatremia Hyponatremia condition record of any type; successive records with > 90 day gap are considered independent episodes 122 123 Hypotension Hypotension condition record of any type; successive records with > 90 day gap are considered independent episodes 124 Impotence The first condition record of impotence 125 126 127 128 Ischemic stroke Ischemic stroke condition record during an inpatient or ER visit; successive records with > 180 day gap are considered independent episodes 91 12 13 101 129 Malignant neoplasm First occurrence of malignant neoplasm, followed by at least one additional diagnosis of the same type (melanoma, bladder, brain, breast, colon and rectum, kidney, leukemia, liver, lung, lymphoma, multiple myeloma, ovary, pancreas, prostate, thyroid, uterus, myelodysplastic syndrome) 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 Measured renal dysfunction The first creatinine measurement with value > 3 mg/dL 26 Nausea Nausea condition record of any type; successive records with > 30 day gap are considered independent episodes 4 146 147 Neutropenia or agranulocytosis The first condition record of neutropenia or agranulocytosis 148 149 Rash Rash condition record of any type; successive records with > 90 day gap are considered independent episodes 150 Rhabdomyolysis Rhabdomyolysis condition record or muscle disorder condition record with creatine measurement 5*ULN during an inpatient or ER visit; successive records with >90 day gap are considered independent episodes 151 152 Stroke Stroke (ischemic or hemorrhagic) condition record during an inpatient or ER visit; successive records with > 180 day gap are considered independent episodes 91 12 13 43 101 102 103 104 105 129 Sudden cardiac death Sudden cardiac death condition record during an inpatient or ER visit; successive records with > 180 day gap are considered independent episodes 12 41 Syncope Syncope condition record of any type; successive records with > 180 day gap are considered independent episodes 124 Thrombocytopenia The first condition record of thrombocytopenia 146 153 154 Transient ischemic attack Transient ischemic attack condition record during an inpatient or ER visit; successive records with > 30 day gap are considered independent episodes 101 129 Type 2 diabetes mellitus The first condition record of Type 2 Diabetes Mellitus, which is followed by another Type 2 Diabetes Mellitus condition record, at least 2 drugs used to treat Type 2 diabetes, or at least 2 HbA1c measurements with value > 6.5% 67 155 156 157 Unstable angina Inpatient or ER visits with preinfarction syndrome condition record; all qualifying inpatient visits occurring > 7 days apart are considered independent episodes 48 158 159 Vasculitis The first condition record of vasculitis, which is followed by another vasculitis condition record or drug to treat vasculitis 160 161 Venous thromboembolic events Venous thromboembolism condition record of any type; successive records with > 180 day gap are considered independent episodes 162 163 164 165 Vertigo The first condition record of vertigo 166 Vomiting Vomiting condition record of any type; successive records with > 30 day gap are considered independent episodes 4 146 147

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