studydefines

Studydefines is a proposed framework used in research methodology to establish precise, shareable definitions for study concepts, variables, outcomes, and procedures. The aim is to promote consistency and reproducibility across studies by documenting how key terms are defined and measured.

A studydefine typically includes the term, a formal definition, inclusion and exclusion criteria, measurement methods, units, thresholds, and contextual notes. It is designed to be versioned and linked to a broader definitional ontology or controlled vocabulary to enable interoperability and accurate interpretation across disciplines.

Practically, studydefines can be stored as machine-readable schemas or dictionaries (for example JSON-LD or RDF) beside study protocols and data dictionaries. They may be integrated into study registries, data repositories, and analysis plans to support automated querying, data harmonization, and transparent reporting.

Applications include improving cross-study comparability of outcomes, enabling automated data harmonization, and supporting preregistration and meta-analytic workflows.

Critics argue that rigid definitions risk stifling methodological nuance and may not accommodate context-specific variations. Effective use of studydefines requires governance, clear versioning, community agreement, and ongoing review as methods and technologies evolve.

Example: in a randomized trial of physical activity, a studydefine for "adherence" might specify: Adherence equals the proportion of days with at least 10 minutes of recorded activity, captured by wearable data, within 14-day windows, with imputation rules for missing days.

See also: data dictionary, controlled vocabulary, ontology, protocol registry.