Health Outcomes of Interest

OMOP established an open-source library of Health Outcomes of Interest (HOI) definitions for use in observational studies. These are a subset of all conditions that are of importance due to their historical associations

with drug toxicities, their medical significance, and/or public health implications.

We have found that there is very little consensus in the literature about outcome definitions. We therefore decided to create a library of HOI definitions that cover a wide representation of the prior work for testing in the OMOP experiment: broad and narrow selections of

diagnosis codes, combination of diagnosis codes with diagnostic or therapeutic procedures and lab values.

Library of HOI Definitions

Angioedema

1. Narrow definition

ICD-9 995.1

Concept ID: 500000101
Initiative*: O

2. Narrow definition and diagnostic procedure or drug treatment

ICD-9 995.1
AND within 2 days after the diagnostic code

Diagnostic or therapeutic procedure code for
intubation, tracheostomy or laryngoscopy, OR
Oral antihistamine medication code OR
i.v. or i.m. anaphylactic shock medication code of
steroids, H1-blockers and H2-blockers

Concept ID: 500000102
Initiative*: O, M

Aplastic Anemia

1. Broad definition

ICD-9 284.0*, 284.8*, 284.9

Concept ID: 500000201
Initiative*: O

2. Broad definition and diagnostic procedure

ICD-9:284.0*, 284.8*, 284.9
AND within 60 days prior to the diagnostic code

Diagnostic procedure code for bone marrow aspiration or biopsy

Concept ID: 500000202
Initiative*: O, E

3. Narrow definition and diagnostic procedure

ICD-9 284.8*
AND within 60 days prior to the diagnostic code

Diagnostic procedure code for bone marrow aspiration or biopsy

Concept ID: 500000203
Initiative*: O

4. Lab-based definition

Occurrence of two out of three following lab tests and test results within a 7 day period

Leukocyte count <= 3.5 x 10^9/L
Platelet count <= 50 x 10^9 /L
Hemoglobin <= 100 g/L

Concept ID: 500000204
Initiative*: O

5. Narrow definition and lab-based defintion

Definition #3 AND Definition #4

Concept ID: 500000205
Initiative*: O

Acute Liver Injury

1. Broad definition

ICD-9 277.4, 570*, 572.2, 572.4*, 573*, 576.8, 782.4, 789.1*, 790.4*, 794.8*

Concept ID: 500000301
Initiative*: O

2. Narrow Definition

ICD-9 570*, 572.2, 572.4*, 573*

Concept ID: 500000302
Initiative*: O, E

3. Narrow definition and therapeutic procedure

Definition #2 (narrow definition)
AND within 30 days prior to diagnostic code

Diagnostic procedure code

AND within 60 days after the diagnostic code

Therapeutic procedure code

Concept ID: 500000303
Initiative*: O

4. Narrow definition, diagnostic procedure and Hy’s Law

Definition #2 (narrow definition)
AND within 30 days prior to diagnostic code

Diagnostic procedure code

AND within 60 days after the diagnostic code

Therapeutic procedure code

AND

Definition #5 (Hy’s law)

Concept ID: 500000304
Initiative*: O

5. Laboratory-based defintion indicative of Hy’s Law

Laboratory results indicative of Hy’s law:
(ALT >= 3xULN OR AST >= 3xULN) AND Bilirubin >= 2xULN
within 7 days.

Concept ID: 500000305
Initiative*: O

6. Laboratory-based defintion strongly indicative of Hy’s law

Lab tests and test results within 7 day period

Alanine aminotransferase >= 10 times the upper
limit of normal as defined in OBS_RANGE_HIGH, or
40 IU/L if not available
Aspartate aminotransferase >= 10 times the upper
limit of normal as defined in OBS_RANGE_HIGH, or
40 IU/L if not available

AND

Total bilirubin >= 2 times the upper limit of normal as
defined in OBS_RANGE_HIGH, or 1.2 mg/dL if not
available

Concept ID: 500000306
Initiative*: O

7. Alternative narrow definition

ICD-9 570*, 572.4, 573.0, 573.1, 573.4

Concept ID: 500000307 Initiative*: O

8. Narrow definition with hospitalization

ICD-9 570*, 572.2, 572.4*, 573*

AND at date of diagnostic code

Hospitalization

Concept ID: 500000308
Initiative*: O

Acute Kidney Injury

1. Narrow definition

ICD-9 584*

Concept ID: 500000401
Initiative*: O

2. Narrow definition and diagnostic procedure

Definition #1
AND

ICD-9 procedure codes 39.95, 54.98

AND excluding anytime before the diagnostic code

Diagnostic code of chronic dialysis status ICD-9
V45.1, V56.0, V56.31, V56.32, V56.8

Concept ID: 500000402
Initiative*: O, E

3. Lab-based defintion

Occurrence of the LOINC lab test codes 2160-0 and test
results Serum creatinine >= 0.5 mg/dL for patients with a
baseline level of <= 1.9 mg/dLSerum creatinine >= 1.0 mg/dL
for patients with a baseline level of 2.0–4.9 mg/dLSerum
creatinine >= 1.5 mg/dL for patients with a baseline level >=
5.0 mg/dL. The baseline level is defined as the occurrence of
most recent lab test result any time prior to the elevated test
result.

Concept ID: 500000403
Initiative*: O

4.
Narrow definition

ICD-9 584, 584.5, 584.6, 584.7

Concept ID: 500000404
Initiative*: O

5. Narrow definition with hospitalization

Definition of Acute Renal Failure #1 AND Hospitalization at date of diagnostic code.

Concept ID: 500000405
Initiative*: O

Bleeding

1. Broad definition

Broad diagnosis code

Concept ID: 500000501
Initiative*: O

2. Broad definition with hospitalization

Definition #1
AND Hospitalization at date of diagnostic code

Concept ID: 500000502
Initiative*: O, E

3. Narrow definition

Diagnosis code.

Concept ID: 500000503
Initiative*: O

Hip Fracture

1. Narrow definition

ICD-9 820*

Concept ID: 500000601
Initiative*: O

2. Narrow definition and diagnostic radiological procedure

Definition #1
AND

diagnostic radiological procedure code
within 30 days prior to diagnostic code

Concept ID: 500000602
Initiative*: O, E

3. Broad definition, or text evidence in radiological procedure, and radiological and therapeutic procedure

Definition #1

OR Text evidence of fracture in radiological procedure results

AND diagnostic radiological procedure code within 30 days
prior to diagnostic code
AND therapeutic procedure code within 60 days after the
diagnostic date.

Concept ID: 500000603
Initiative*: O

4. Narrow definition, radiological and therapeutic procedure

Definition #1
AND diagnostic radiological procedure code within 30 days
prior
to diagnostic code
AND therapeutic procedure code within 60 days after the
diagnostic date.

Concept ID: 500000604
Initiative*: O

Hospitalization

1. Narrow definition

Occurrence of visit with visit type for hospitalization.

Concept ID: 500000701
Initiative*: O

Acute Myocardial Infarction

1. Broad definition with hospitalization

ICD9 410*, 411.1, 411.8*

angina (413.9) during hospitalization.

Concept ID: 500000801
Initiative*: O

2. Narrow definition

ICD-9 410*.

Concept ID: 500000802
Initiative*: O, M, E

3. Narrow definition, diagnostic and treatment procedure

Narrow diagnosis code
AND (diagnostic procedure <=30d before diagnosis

(treatment procedure >=60d after diagnosis)

Concept ID: 500000803
Initiative*: O

4. Lab-based definition

Laboratory results indicative of AMI

Concept ID: 500000804
Initiative*: O

5. Narrow definition with hospitalization

Definition of Acute Myocardial Infarction (410*) #2
AND Hospitalization at date of diagnostic code

Concept ID: 500000805
Initiative*: O

Mortality After Myocardial Infarction

1. Narrow definition, with hospitalization

Date of death after broad diagnosis code
ICD9 410*, 411.1, 411.8*

angina (413.9) during hospitalization

Concept ID: 500000901
Initiative*: O

2. Narrow definition

Date of death after narrow diagnosis code
ICD9 410*

Concept ID: 500000902
Initiative*: O

3. Narrow definition, diagnostic and treatment procedure

Date of death after narrow diagnosis code
AND (diagnostic procedure <=30d before diagnosis

(treatment procedure >=60d after diagnosis)

Concept ID: 500000903
Initiative*: O

4. Lab-based definition

Date of death after laboratory results indicative of AMI

Concept ID: 500000904
Initiative*: O

GI Ulcer Hospitalization

1. Broad definition with hospitalization

Occurrence of at least one diagnostic code (See sheet ICD9 Code)
AND Hospitalization (Concept Ids 9201 and 9203, Inpatient Visit and Emergency Room Visit) at date of diagnostic code

Concept ID: 500001001
Initiative*: O, E

2. Narrow definition and diagnostic procedure with hospitalization

Diagnostic code AND Hospitalization at date of diagnostic
code
AND diagnostic procedure (endoscopy) within the same
hospitalization.

Concept ID: 5000001002
Initiative*: O

3. Narrow definition without hospitalization

Definition of Upper GI Ulcer Hospitalization 1 but without hospitalization.

Concept ID: 5000001003
Initiative*: O

Anaphylaxis

1. Narrow definition

ICD-9 995.0

Concept ID: 500001101
Initiative*: M, E

Pancytopenia

1. Narrow definition

ICD-9 284.1

Concept ID: 500001201
Initiative*: E

Stevens-Johnson Syndrome

1. Broad definition

ICD-9 695.1

Concept ID: 500001301
Initiative*: M, E

2. Alternative narrow definition

ICD-9 695.1*

Concept ID: 500001302
Initiative*: E

Hemolytic Anemia

1. Narrow definition

ICD-9 283.0, 283.1, 283.9

Concept ID: 500001401
Initiative*:

ILD and Eosinophilic Pneumona

1. Narrow definition

ICD-9 518.3, 515, 516.3

Concept ID: 500001501
Initiative*:

Neutropenia

1. Narrow definition

ICD-9 288.0*

Concept ID: 500001601
Initiative*: E

Pancreatitis

1. Narrow definition

ICD-9 577.0

Concept ID: 500001701
Initiative*: M, E

Qt Prolongation/Torsade De Pointes

1. Narrow definition

ICD-9 426*, 427*

Concept ID: 500001801
Initiative*: M

Rhabdomyolysis

1. Narrow definition

ICD-9 728.88

Concept ID: 500001901
Initiative*: E

Serum Sickness

1. Narrow definition

ICD-9 999.5

Concept ID: 500002001
Initiative*: M

Suicidality

1. Narrow definition

ICD-9 E950-E959

Concept ID: 500002101
Initiative*: M

Thrombocytopenia including Immune Thrombocytopenic Purpura

1. Narrow definition

ICD-9 287.3

Concept ID: 500002201
Initiative*:

Acute Respiratory Failure

1. Narrow definition

ICD-9 518.81, 518.82

Concept ID: 500002301
Initiative*: M

Atrial Fibrillation

1. Narrow definition

ICD-9 427.31

Concept ID: 500002401
Initiative*: M

Cardiac valve Fibrosis

1. Broad definition

ICD-9 394.9,395,396.1,396.3,397.0,420.0,424.1,424.3

Concept ID: 500002501
Initiative*: E

Congestive Heart Failure

1. Narrow definition

ICD-9 428*

Concept ID: 500002601
Initiative*: M

Depression

1.Narrow definition

ICD-9 296.2*, 296.3*, 311

Concept ID: 500002701
Initiative*: M

Lymphoma

1. Narrow definition and diagnostic, radiation, chemotherapy procedure, or chemotheraputic drugs

ICD-9 (200*, 201*, 202*)
AND
((lymph node biopsy, bone marrow biopsy/aspiration,
laparascopic staging, path report before radiation/chemo,
PET scan) 30d before

((radiation, chemotherapy procedure) or
(chemotherapeutic drugs) 30d after)

Concept ID: 500002801
Initiative*: M

Progressive Multifocal Leukoencephalopathy

1. Narrow definition

ICD-9 046.3

Concept ID: 500002901
Initiative*: E

Pulmonary Fibrosis

1. Narrow definition

ICD-9 515, 516.3

Concept ID: 500003001
Initiative*: M

Siezure

1. Narrow definition

ICD-9 345*, 333.2

Concept ID: 500003101
Initiative*: M

Stroke

1. Broad definition

ICD-9 430*,431*,434*,436*

Concept ID: 500003201
Initiative*: M

Transient Ischemic Attack

1. Narrow definition

ICD-9 435*

Concept ID: 500003401
Initiative*: M

Venous Thromboembolism

1. Narrow definition

ICD-9 415.1*, 451*, 453*

Concept ID: 500003601
Initiative*: M

* Initiatives: E - EUADR; M - ; O - Original Reviewed: Dec. 2013
 
  • Background
  •  
  • HOI Implementation
  •  
  • OMOP Experiments
  •  
  • Summary of definitions
  •  
  • Community

  • Related Publications

    Drug Safety 36(1) Supplement. Published online: 29 Oct. 2013
    Alternative outcome definitions and their effect on the performance of methods for observational outcome studies


    Christian Reich, Patrick B. Ryan, Martijn J. Schuemie.

    Keywords
    Health outcomes, definitions, claims database, electronic health record database, surveillance, drug safety surveillance, acute kidney injury, acute liver injury, acute myocardial infarction



    29th ICPE, August 25-28, 2013
    Alternative outcome definitions and their effect on observational outcome studies

    Christian Reich, on behalf of the OMOP research team
     

    HOI Implementation

    The majority of the HOI definitions can be implemented with Regularized Identification of Cohorts (RICO). RICO is a procedure that standardizes patient cohort selection. To create HOIs, RICO is employed using cohort definitions are created

    using criteria that are specified in input parameters. Patients meeting the criteria are selected from the common data model. The majority of HOI definitions can be implemented using RICO. Two exceptions are the "Acute Myocardial Infarction Definition #4" and the

    "Mortality after MI Definition #4", which both involve application of the American College of Cardiology definition that includes a complicated set of criteria about troponin, CK, and EKG results. A stand-alone SAS procedure for identifying the AMI#4 cohort was developed, but

    is untested for lack of relevant EKG data in the central databases within the OMOP Research Lab. However, the SAS code is available to the broader OMOP research community to adapt to their data, at http://omop.org/PrepData. There is no SQL version of this script.
    Another exception is Hip Fracture Definition #3, which involves text evidence from radiology reports which is not available for development and testing within the Research Lab. An implementation of this definition should be undertaken if the data source supports this kind of
    information.

    Background

    The Implementation of the HOI Definition Process in OMOP
    A Request for Proposal was disseminated and members of the OMOP research team, Scientific Advisory Board, and Executive Committee selected two independent research organizations after careful evaluation of proposals. Both organizations selected had extensive

    experience in systematic reviews of the literature to inform meta-analysis, guideline development, and evidence-based medicine reviews.

    The OMOP research team defined the following process to be independently followed by the two HOI

    research organizations:

    1. Develop optimal search strategy to identify published manuscripts of studies of an HOI in

      observational datasets

    2. Identify the relevant literature of studies conducted in observational databases that would inform

      our definition of an HOI.
      These were to include any studies reporting definitions, validation studies that measure case

      ascertainment performance (including sensitivity, specificity, positive predictive value), coding

      guidelines and clinical diagnostic guidelines

    3. For each paper, summarize results in an evidence table to help inform the final definition to be

      implemented in OMOP studies

    No communication between the two HOI research organizations was permitted. The research organizations were also asked to identify and abstract clinical guidelines for a given HOI to help further inform the OMOP research team.
    The OMOP research team, in collaboration with the two research organizations, developed the evidence table format. The OMOP researchers evaluated actual search strategies and the articles retrieved from each research team as the effort progressed to identify and

    correct obvious shortcomings in search strategy or results based mainly on relevant citations that were identified by the OMOP researchers but were not captured in the research organization searches. These article citations were provided to the research organization to

    help them identify gaps in their search strategies.
    An analysis of the systematic reviews was conducted to assess the concordance between the reviews and to develop a composite search strategy that took advantage of the positive attributes and capture of each review. The goal of the composite search strategy to

    increase the capture of relevant observational database and validation studies and was based on the findings from the independent research organizations. The composite search strategy was implemented in PubMed, and all returned articles were abstracted to determine

    the relevance based on the original criteria provided to the independent reviewers. Studies conducted outside an observational database or that did not include a specific definition were intended to be excluded from the evidence tables. Relevant articles identified by

    designated members of the OMOP research team using the composite search strategy were compared to those studies identified by each of the two independent reviews. Comparisons between the research organization findings and the composite OMOP research team

    effort were undertaken to determine the effectiveness of the composite search strategy and the extent to which the findings between the two research organizations agreed.

    OMOP Phase

    HOI process being conducted within the OMOP Project

    Phases

    Phase 1

    a. Perform systematic literature review for each Health Outcome of Interest

    • Identify clinical diagnostic criteria and coding guidelines
    • Extract operational definitions previously used in observational studies
    • Describe any validation studies that measure case ascertainment performance (including

      sensitivity, specificity, positive predictive value)

    • Synthesize national estimates of prevalence of disease (if available)

    b. Draft HOI design document characterizing the pool of potential definitions to consider in

    observational data

    • Submit HOI definition design document for public comment and review by Scientific Advisory

      Board

    • Elicit feedback from experts in specific clinical domains

    Phase 2

    a. Develop software code to apply definitions to Research Core databases (on raw data and common data

    model)
    b. Compare the prevalence of HOI in each observational data source with a national estimate or other

    published data
    c. Conduct descriptive analysis of the ‘natural history’ of the HOI (including demographics, prior

    conditions, prior drug utilization) in each source
    d. Validate HOIs in the data source if available

    Phase 3

    a. Integrate summary of OMOP analyses for each HOI
    b. Draft recommended best practices for HOI definition and solicit public feedback
    c. Publish standardized HOI summary document