Table of Contents

Adding PROM data to CDM

Proposals now housed on github

link to github

Background

ICON plc is currently engaged in a project with ICHOM (International Consortium for Health Outcomes Measurement.

“ICHOM's mission is to unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that really matter to patients for the most relevant medical conditions and by driving adoption and reporting of these measures worldwide.”

ICHOM brings together patient representatives, clinician leaders, and registry leaders from all over the world to develop Standard Sets, comprehensive yet parsimonious sets of outcomes and case-mix variables for specific medical conditions that ICHOM recommends all providers track.

Each Standard Set focuses on patient-centered results, and provides an internationally-agreed upon method for measuring each of these outcomes. ICHOM believes that standardized outcomes measurement will open up new possibilities to compare performance globally, allow clinicians to learn from each other, and rapidly improve the care provided to patients.

ICHOM Standard Sets include baseline conditions and risk factors to enable meaningful case-mix adjustment globally, ensuring that comparisons of outcomes will take into account the differences in patient populations across not just providers, but also countries and regions. They also include high-level treatment variables to allow stratification of outcomes by major treatment types. A comprehensive data dictionary, as well as scoring guides for patient-reported outcomes is provided for each Standard Set.

Proposal

ICON plc is developing a platform to ingest, store and analyse the outcome measures and is using the OMOP Common Data Model to store the data. The current CDM satisfies many of the requirements, but there are some gaps, specifically:

Domain Vocabulary
SURVEY LOINC (PhenX and EQ-5D are both captured within this existing vocabulary), OMOP Custom (including ICHOM?)
*each survey included may require end user license agreements
QUESTION LOINC (PhenX and EQ-5D are both captured within this existing vocabulary), OMOP Custom (including ICHOM?)
*each survey included may require end user license agreements

SURVEY table

(other potential table name options: PRO, PATIENT_REPORTED_OUTCOME, PROM, others?)

Field
Proposed revision
Required Type Description Field
Reference from original proposal, if revised
SURVEY_
OCCURRENCE_ID
Yes integer Unique identifier for each completed survey SURVEY_ID
SURVEY_
CONCEPT_ID
Yes integer A foreign key that refers to a survey Concept identifier in the Standardized Vocabularies
PERSON_ID Yes integer A foreign key identifier to the Person in the PERSON table about whom the survey was completed
VISIT_
OCCURRENCE_ID
No integer A foreign key to the visit in the visit table during which the the treatment was carried out that relates to this survey
SURVEY_DATE Yes date Date on which the survey was completed
ASSISTED_
CONCEPT_ID
No integer A foreign key that refers to a data source Concept identifier in the Standardized Vocabularies
Example:
Yes = concept_id 45877994; LOINC concept_code LA33-6
No = concept_id 45878245; LOINC concept_code LA32-8
ASSISTED_IND
_CONCEPT_ID
ASSISTED_IND No varchar(10) ICHOM code representing whether patient required assistance to complete the survey - 1=Completed without assistance, 2=Completed with assistance
SURVEY_RECORDER
_CONCEPT_ID
No integer A foreign key that refers to a data source Concept identifier in the Standardized Vocabularies
Example:
Research Associate = concept_id 4074477; SNOMED concept_code 224614003
Patient = concept_id 4023409; SNOMED concept_code 116154003
DATA_SOURCE
_CONCEPT_ID
SURVEY_RECORDER
_SOURCE_VALUE
No varchar(10) ICHOM code representing role of person who completed the survey - e.g. 1=Administrative, 2=Clinician, 3=Patient-reported DATA_SOURCE
TIMING_
CONCEPT_ID
No integer A foreign key that refers to a timing Concept identifier in the Standardized Vocabularies
Example:
3 month follow-up = concept_id 44789369; SNOMED obs concept_code 200521000000107
TIMING_
SOURCE_VALUE
No varchar(100) Text string representing the timing of the survey - e.g. 'BASELINE'
COLLECTION_
METHOD_CONCEPT_ID
No varchar(10) A foreign key that refers to a collection method Concept identifier in the Standardized Vocabularies
Example:
Telephone Reported = concept_id 4084141; obs SNOMED concept_code 281313006
COLLECTION_METHOD No varchar(10) The collection type as it appears in the source data.This code is mapped to a Standard Concept in the Standardized Vocabularies and the original code is stored here for reference.
Example:
ICHOM code representing method of capturing responses in survey - e.g. 1=Paper, 2=Telephone, 3=Electronic Questionnaire
DURATION No varchar(50) Time taken to complete survey HH:MM:SS
SURVEY_
SOURCE_VALUE
No varchar(100) The survey name/title as it appears in the source data. This code is mapped to a Standard Concept in the Standardized Vocabularies and the original code is stored here for reference. SURVEY_NAME
SURVEY_
SOURCE_IDENTIFIER
No varchar(100) Unique identifier for each completed survey in source system SURVEY_
SOURCE_VALUE
VALIDATED_
SURVEY_
CONCEPT_ID
No Integer A foreign key that refers to a data source Concept identifier in the Standardized Vocabularies
Example:
Yes = concept_id 45877994; LOINC concept_code LA33-6
No = concept_id 45878245; LOINC concept_code LA32-8
VALIDATED_SURVEY
_SOURCE_VALUE
No varchar(50) The validated survey identifier as it appears in the source data. This code is mapped to a Standard Concept in the Standardized Vocabularies and the original code is stored here for reference.

RESPONSE table

Field Required Type Description
RESPONSE_OCCURRENCE_ID Yes integer Unique identifier for each response.
PERSON_ID Yes integer A foreign key identifier to the Person in the PERSON table about whom the response was recorded.
SURVEY_OCCURRENCE_ID Yes integer A foreign key to SURVEY table about which survey the question and response occurred.
QUESTION_CONCEPT_ID Yes integer A foreign key that refers to a question Concept identifier in the Standardized Vocabularies
QUESTION_SOURCE_VALUE No varchar(255) The question as it appears in the source data. This code is mapped to a Standard Concept in the Standardized Vocabularies and the original code is, stored here for reference.
RESPONSE_DATE Yes date Date on which the response was recorded
RESPONSE_DATETIME No datetime Date and time on which the response was recorded
RESPONSE_AS_CONCEPT_ID Yes integer Foreign key that refers to a response Concept identifier in the Standardized Vocabularies
RESPONSE _AS_STRING No varchar(255) The response stored as a string. This is applicable to questions where the result is expressed as verbatim text.
RESPONSE _AS_NUMBER No float The response stored as a number. This is applicable to questions where the result is expressed as a numeric value.
RESPONSE_AS_DATETIME No datetime The response stored as a datetime. This is applicable to questions where the result is expressed as a historical date/time.
RESPONSE_RANGE_LOW No varchar(50) The lowest value of the range of responses for the question.
RESPONSE_RANGE_HIGH No varchar(50) The highest value of the range of responses for the question

Use Cases

Example is for observation made through Question 1 (HPS1) on the HOOSPS survey (Hip Disability and Osteoarthritis Outcome Score). The question asks the degree of difficulty in descending stairs due to the patient's hip problem. The patient answers “Moderate”.

CONCEPT table - example

CONCEPT_ID CONCEPT _NAME DOMAIN_ID VOCABULARY_ID CONCEPT_ CLASS_ID STANDARD _CONCEPT CONCEPT _CODE
2020 HPS1 Metadata Domain Domain ICHOM generated
2021 None HPS1 ICHOM Observation PRO Measure S 0
2022 Mild HPS1 ICHOM Observation PRO Measure S 1
2023 Moderate HPS1 ICHOM Observation PRO Measure S 2
2024 Severe HPS1 ICHOM Observation PRO Measure S 3
2025 Extreme HPS1 ICHOM Observation PRO Measure S 4

The patient response is captured as a code 0..4 and the CONCEPT_ID is determined by finding a match for the question Variable ID (HPS1) in DOMAIN_ID and the response in the CONCEPT_CODE.

SURVEY table - example

Column Value Comment
SURVEY_OCCURRENCE_ID 19073
SURVEY_CONCEPT_ID 3501 Concept for HOOSPS survey
PERSON_ID 21405
VISIT_OCCURRENCE_ID 13403
SURVEY_DATE 2016-07-14
ASSISTANCE_CONCEPT_ID 3601 Concept for “Completed without assistance”
ASSISTANCE_SOURCE_VALUE 1 ICHOM value for “Completed without assistance”
SURVEY_RECORDER_CONCEPT_ID 3611 Concept for “Patient-reported”
SURVEY_RECORDER_SOURCE_VALUE 3 ICHOM value for “Patient-reported”
TIMING_CONCEPT_ID 3621 Concept for “BASELINE” timing
TIMING_SOURCE_VALUE BASELINE
COLLECTION_METHOD_CONCEPT_ID 3631 Concept for “Electronic questionnaire”
COLLECTION_METHOD_SOURCE_VALUE 3 ICHOM value for “Electronic questionnaire”
DURATION_TIME 00:07:45 Patient took 7 minutes and 45 seconds to complete online survey
SURVEY_SOURCE_VALUE HOOSPS
SURVEY_SOURCE_IDENTIFIER HS001234
VALIDATED_SURVEY_CONCEPT_ID 3701 Concept for “Validated survey”
VALIDATED_SURVEY_SOURCE_VALUE 1 ICHOM value for “Validated Survey”

RESPONSE table - example

Column Value Comment
RESPONSE_OCCURRENCE_ID 794657
PERSON_ID 21405
SURVEY_OCCURRENCE_ID 19073
QUESTION_CONCEPT_ID 2020 Concept for HPS1
QUESTION_SOURCE_VALUE HPS1
RESPONSE_DATE 2016-07-14
RESPONSE_DATETIME
RESPONSE_AS_CONCEPT_ID 2023 Concept for “Moderate”
RESPONSE _AS_STRING
RESPONSE _AS_NUMBER
RESPONSE_AS_DATETIME
RESPONSE_RANGE_LOW 0
RESPONSE_RANGE_HIGH 4