dQM CMS Content Implementation Guide
2026.1.0 - CI Build

dQM CMS Content Implementation Guide, published by cqframework. This guide is not an authorized publication; it is the continuous build for version 2026.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cqframework/dqm-content-cms-2026/ and changes regularly. See the Directory of published versions

## Library: NCT01980823 Eligibility Criteria

Official URL: https://research.balgrist.ch/Library/NCT01980823EligibilityCriteria | Version: 1.0.0
Active as of 2026-05-17 | Computable Name: NCT01980823EligibilityCriteria

NCT01980823 Eligibility Criteria

Metadata
Title | NCT01980823 Eligibility Criteria
Version | 1.0.0
Topic | FHIR
Topic | CQL
Description | NCT01980823 Eligibility Criteria
Type | logic-library from http://terminology.hl7.org/CodeSystem/library-type
Parameter | Name: Patient Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: Patient
Parameter | Name: Is Female Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Has Histologically Confirmed Breast Cancer or DCIS Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Has Operable Tumor With Planned Surgical Excision Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Tumor Size At Least 5mm Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Is At Least 21 Years Old Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: No Prior Treatment Within 6 Months Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Has Acceptable ECOG Status Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Has Signed Informed Consent Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: On Diabetes Or Hypercholesterolemia Medication Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: On Investigational Drug Within 6 Months Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: On Strong CYP3A4 Inhibitor Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Has Renal Impairment Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Has Gilberts Syndrome Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Has Hepatic Impairment Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Meets Inclusion Criteria Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Meets Exclusion Criteria Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Parameter | Name: Is Eligible Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean
Data Requirement | Type: Condition Profile(s): Condition Code Filter(s): Path: code Code(s): SNOMED CT: 254838004 (Carcinoma of breast)
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Tumor Size Observations
Data Requirement | Type: Procedure Profile(s): Procedure
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code Code(s): LOINC: 89247-1 (ECOG Performance Status score)
Data Requirement | Type: Consent Profile(s): Consent
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code Code(s): SNOMED CT: 713670002 (Entered into drug clinical trial)
Data Requirement | Type: MedicationRequest Profile(s): MedicationRequest
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Serum Creatinine Lab Tests
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Aspartate Transaminase (AST/SGOT) Lab Tests
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Alanine Transaminase (ALT/SGPT) Lab Tests
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Total Bilirubin Lab Tests
Data Requirement | Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Alkaline Phosphatase Lab Tests
Library Content
CQL Content |
    library NCT01980823EligibilityCriteria version '1.0.0'

    using FHIR version '4.0.1'

    include hl7.fhir.uv.cql.FHIRHelpers version '4.0.1' called FHIRHelpers
    include hl7.fhir.uv.cql.FHIRCommon version '2.0.0' called FHIRCommon

    codesystem "SNOMED-CT": 'http://snomed.info/sct'
    codesystem "LOINC": 'http://loinc.org'

    // --- VALUESETS ---

    valueset "Chemotherapy or Radiation or Breast Resection Codes":
      'https://example.org/fhir/ValueSet/chemo-radiation-breast-resection'

    valueset "Diabetes or Hypercholesterolemia Medications":
      'https://example.org/fhir/ValueSet/diabetes-hypercholesterolemia-medications'

    valueset "Strong CYP3A4 Inhibitor Medications":
      'https://example.org/fhir/ValueSet/strong-cyp3a4-inhibitors'

    valueset "Serum creatinine":
      'https://example.org/fhir/ValueSet/serum-creatinine'
      //'https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.3.526.3.1139'

    valueset "AST":
      'https://example.org/fhir/ValueSet/ast-lab-tests'

    valueset "ALT":
      'https://example.org/fhir/ValueSet/alt-lab-tests'

    valueset "Total Bilirubin":
      'https://example.org/fhir/ValueSet/total-bilirubin'

    valueset "Alkaline Phosphatase":
      'https://example.org/fhir/ValueSet/alkaline-phosphatase'

    valueset "Core needle biopsy":
      'https://example.org/fhir/ValueSet/core-needle-biopsy'

    valueset "Histologic test":
      'https://example.org/fhir/ValueSet/histologic-test'

    valueset "Tumor Size Observations":
      'https://example.org/fhir/ValueSet/tumor-size-observations'

    // --- CODES ---

    code "Female": '248152002' from "SNOMED-CT" display 'Female (finding)'
    code "Carcinoma of breast": '254838004' from "SNOMED-CT" display 'Carcinoma of breast'
    code "ECOG Performance Status": '89247-1' from "LOINC" display 'ECOG Performance Status score'
    code "Informed consent given": '203031000000107' from "SNOMED-CT" display 'Informed consent given'
    code "Entered into drug clinical trial": '713670002' from "SNOMED-CT" display 'Entered into drug clinical trial'

    // --- CONTEXT ---

    context Patient

    // ===========================
    // INCLUSION CRITERIA
    // ===========================

    // 1. Female
    define "Is Female":
      Patient.gender = 'female'

    // 2. Histologically confirmed invasive breast cancer or DCIS
    define "Has Histologically Confirmed Breast Cancer or DCIS":
      exists (
        [Condition: "Carcinoma of breast"] C
          where C.verificationStatus ~ FHIRCommon."confirmed"
            and exists (
              C.evidence E
                where E.code in "Histologic test"
            )
      )

    // 3. Operable tumor with core needle biopsy followed by surgical excision >= 2 weeks after enrollment
    define "Has Operable Tumor With Planned Surgical Excision":
      exists (
        [Procedure: "Core needle biopsy"] P
          where P.status = 'completed'
      )
      // Surgical excision timing (>= 2 weeks post-enrollment) assumed tracked externally

    // 4. Tumor size >= 5 mm by imaging or pathology
    define "Tumor Size At Least 5mm":
      exists (
        [Observation: "Tumor Size Observations"] O
          where O.status in { 'final', 'amended' }
            and (O.value as FHIR.Quantity) >= 5 'mm'
      )

    // 5. Age >= 21 years
    define "Is At Least 21 Years Old":
      AgeInYears() >= 21

    // 6. No prior chemo, radiation, or breast resection within 6 months of study entry
    define "No Prior Treatment Within 6 Months":
      not exists (
        [Procedure] P
          where P.status = 'completed'
            and P.code in "Chemotherapy or Radiation or Breast Resection Codes"
            and P.performed.toInterval() ends 6 months or less before Today()
      )

    // 7. ECOG Performance Status 0-1
    define "Has Acceptable ECOG Status":
      exists (
        [Observation: "ECOG Performance Status"] O
          where O.status in { 'final', 'amended' }
            and (O.value as FHIR.integer) in Interval[0, 1]
      )

    // 8. Signed informed consent
    define "Has Signed Informed Consent":
      exists (
        [Consent] C
          where C.status = 'active'
      )

    // ===========================
    // EXCLUSION CRITERIA
    // ===========================

    // 9. Currently on medication for diabetes or hypercholesterolemia
    define "On Diabetes Or Hypercholesterolemia Medication":
      exists (
        [MedicationRequest] M
          where M.status = 'active'
            and M.medication in "Diabetes or Hypercholesterolemia Medications"
      )

    // 10. Treatment with investigational drugs within 6 months
    define "On Investigational Drug Within 6 Months":
      exists (
        [Observation: "Entered into drug clinical trial"] O
          where O.effective ends 6 months or less before Today()
      )

    // 11. Strong CYP3A4 inhibitor use (e.g. clarithromycin, HIV protease inhibitors, itraconazole)
    define "On Strong CYP3A4 Inhibitor":
      exists (
        [MedicationRequest] M
          where M.status = 'active'
            and M.medication in "Strong CYP3A4 Inhibitor Medications"
      )

    // 12. Renal impairment: creatinine > 1.4 mg/dL
    define "Has Renal Impairment":
      exists (
        [Observation: "Serum creatinine"] O
          where O.status in { 'final', 'amended' }
            and (O.value as FHIR.Quantity) > 1.4 'mg/dL'
      )

    // TODO: Define Gilberts Syndrome
    define "Has Gilberts Syndrome":
      false

    define fluent function "Upper Limit of Normal"(O Observation):
      if exists(O.referenceRange) then
        O.referenceRange[0].high
      else
        null

    // 13. Hepatic impairment
    define "Has Hepatic Impairment":
      exists (
        [Observation: "AST"] O
          where (O.value as FHIR.Quantity) >= 2.5 * O."Upper Limit of Normal"()
      )
      or exists (
        [Observation: "ALT"] O
          where (O.value as FHIR.Quantity) >= 2.5 * O."Upper Limit of Normal"()
      )
      or exists (
        [Observation: "Total Bilirubin"] O
          where (O.value as FHIR.Quantity) >= 1.5 * O."Upper Limit of Normal"()
            and not "Has Gilberts Syndrome"
      )
      or exists (
        [Observation: "Alkaline Phosphatase"] O
          where (O.value as FHIR.Quantity) > 2.5 * O."Upper Limit of Normal"()
      )

    // ===========================
    // COMPOSITE ELIGIBILITY
    // ===========================

    define "Meets Inclusion Criteria":
      "Is Female"
        and "Has Histologically Confirmed Breast Cancer or DCIS"
        and "Has Operable Tumor With Planned Surgical Excision"
        and "Tumor Size At Least 5mm"
        and "Is At Least 21 Years Old"
        and "No Prior Treatment Within 6 Months"
        and "Has Acceptable ECOG Status"
        and "Has Signed Informed Consent"

    define "Meets Exclusion Criteria":
      "On Diabetes Or Hypercholesterolemia Medication"
        or "On Investigational Drug Within 6 Months"
        or "On Strong CYP3A4 Inhibitor"
        or "Has Renal Impairment"
        or "Has Hepatic Impairment"

    define "Is Eligible":
      "Meets Inclusion Criteria"
        and not "Meets Exclusion Criteria"
ELM XML Content |
    Encoded data (176168 characters)
ELM JSON Content |
    Encoded data (347016 characters)
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