Proposal 4: New classes under `value specification` for standardized criterion values

[rralifia]

Issue: Gap 4 – Value specification classes for standardized criterion values

New terms / entities

Value specification subclasses for standardized eligibility / consent values along four axes:

• Sex: male, female
• Race: African American, White, American Indian, Asian, Pacific Islander
• Health status categories:
  • Dermatologic
  • Cancer / neoplasms
  • Ear, nose & throat
  • Endocrine & metabolic
  • Infectious diseases
  • Genetic / congenital & rare
  • Eye & vision
  • Immune & inflammatory
  • Mental & behavioral
  • Musculoskeletal
  • Injury, poisoning & toxic effect
  • Kidney & urologic
  • Gastrointestinal & liver
  • Reproductive & obstetric
  • Respiratory
• Gravidity status: pregnant, not pregnant, possibly pregnant

(ICO maintainers can merge or realign these with existing external ontology terms as appropriate.)

Type

• Classes (subclasses of value specification)

Rationale

ICO already provides a strong pattern for eligibility criteria using classes such as sex inclusion criterion, ethnicity inclusion criterion, health status inclusion criterion, and gravidity inclusion criterion, together with value specification.

However, to support simple faceted querying across consents (e.g., “cancer studies”, “respiratory conditions”, “African American men”, “pregnant women”), we need a small, reusable set of criterion value classes.

These classes are intended as lightweight value specification subclasses that:

• capture high-level values commonly expressed in inclusion criteria and recruitment descriptions;
• allow mapping from heterogeneous free-text descriptions to standardized categories;
• can be reused as fillers of has value specification (or analogous properties) from inclusion criteria.

Below, “Subclass of” is always value specification.

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Details

4.1 Sex-related value specification classes

1. male sex value specification

   • Label: male sex value specification
   • Definition:
     A value specification that specifies that eligible participants must have male sex.
   • Subclass of:
     value specification
   • Example of usage:
     • Clause: “Only male participants will be enrolled.”
     • A sex inclusion criterion instance has has value specification some male sex value specification.

2. female sex value specification

   • Label: female sex value specification
   • Definition:
     A value specification that specifies that eligible participants must have female sex.
   • Subclass of:
     value specification
   • Example of usage:
     • Clause: “We will recruit women aged 18 to 45 years.”
     • The corresponding sex inclusion criterion has has value specification some female sex value specification.

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4.2 Race-related value specification classes

3. African American race value specification
4. White race value specification
5. American Indian race value specification
6. Asian race value specification
7. Pacific Islander race value specification

Shared pattern:

• Label: <race> race value specification
• Definition:
  A value specification that specifies that eligible participants must belong to the indicated race category (e.g., African American, White, American Indian, Asian, Pacific Islander) as understood in the applicable regulatory or study context.
• Subclass of:
  value specification
• Example of usage:
  • Clause (Study NCT05490251): “African American and white men will participate.”
  • The corresponding race inclusion criterion (see Proposal 6: New race inclusion criterion class #43) has
    • has value specification some African American race value specification, and
    • has value specification some White race value specification.

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4.3 Health status category value specification classes

Proposed classes (all subclasses of value specification):

8. dermatologic condition health status value specification
9. cancer or neoplasm health status value specification
10. ear nose and throat condition health status value specification
11. endocrine and metabolic condition health status value specification
12. infectious disease health status value specification
13. genetic congenital or rare condition health status value specification
14. eye and vision condition health status value specification
15. immune and inflammatory condition health status value specification
16. mental and behavioral condition health status value specification
17. musculoskeletal condition health status value specification
18. injury poisoning or toxic effect health status value specification
19. kidney and urologic condition health status value specification
20. gastrointestinal and liver condition health status value specification
21. reproductive and obstetric condition health status value specification
22. respiratory condition health status value specification

Shared pattern:

• Definition:
  A value specification that specifies that eligible participants must have (or have had) a clinically significant condition belonging to the indicated high-level disease or body-system category (e.g., cancer/neoplasms, infectious disease, respiratory condition), as interpreted via an underlying disease ontology (e.g., MONDO, Disease Ontology).
• Subclass of:
  value specification
• Example of usage:
  • Clause (Study NCT05092958):

    “You have been invited… because you have metastatic urothelial cancer.”

  • This can be modeled as a health status inclusion criterion with has value specification some cancer or neoplasm health status value specification, while also recording the specific diagnosis with a disease ontology term.

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4.4 Gravidity status value specification classes

23. pregnant gravidity status value specification
24. not pregnant gravidity status value specification
25. possibly pregnant gravidity status value specification

Shared pattern:

• Definition:
  A value specification that specifies that eligible participants must have the indicated gravidity status (pregnant, not pregnant, or possibly pregnant) at the time relevant to the study (e.g., at enrollment or intervention).
• Subclass of:
  value specification
• Example of usage:
  • Clause: “You may take part in this study if you are currently pregnant.”
    → gravidity inclusion criterion with has value specification some pregnant gravidity status value specification.
  • Clause: “People who are not pregnant may participate.”
    → gravidity inclusion criterion with has value specification some not pregnant gravidity status value specification.