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rwevalidate 0.1.2

CRAN resubmission addressing a second review comment; no functional changes.

• DESCRIPTION: write the HARPER and RECORD-PE framework names in normal capitalization (“Harmonized…”, “Reporting…”, “Pharmacoepidemiology”) instead of the mixed-case styling that the CRAN spell check flagged. The acronyms remain in parentheses.

rwevalidate 0.1.1

CRAN resubmission addressing reviewer feedback; no functional changes.

• DESCRIPTION: all acronyms (OMOP, CDM, RWE, HTML, JSON, FDA, HARPER, RECORD-PE) are now explained at first use, and references follow the authors (year) <doi:...> format.
• Removed the \dontrun{} example from validate_cohort(); the live-database call is now shown in the function’s Details section.
• Added an executable example to cdm_disconnect(). The only remaining \dontrun{} example is cdm_connect(), which requires a live PostgreSQL server and credentials.
• Expanded the Title to spell out “OMOP Common Data Model”.
• example_cdm() now builds a 20-person, two-arm demo CDM (target and comparator), so every exported module — including run_covariates() — has a runnable example against the bundled database.
• Added @examples to run_attrition(), run_density(), run_concepts(), and run_covariates().

rwevalidate 0.1.0

First public release. rwevalidate validates an instantiated OMOP CDM cohort for real-world-evidence use and produces a regulator-aligned HTML + JSON report from a single validate_cohort() call.

Features

• cdm_connect() / cdm_disconnect() - open a PostgreSQL CDM connection and validate that the required clinical tables exist (split-schema aware).
• Module 1 - run_concepts() - concept prevalence, ancestor coverage, and per-domain vocabulary mapping rate (FDA Relevance).
• Module 2 - run_attrition() - cohort size, index-date distribution, prior-observation coverage, and demographics at index (HARPER / RECORD-PE).
• Module 3 - run_density() - records per patient per month by domain and follow-up completeness with a censoring breakdown (FDA Reliability).
• Module 4 - run_covariates() - standardized mean differences (love plot), per-arm prevalence, and a power calculation against a comparator (HARPER).
• Reporting - render_validation_report() writes a self-contained HTML report with a traffic-light summary plus a machine-readable validation_results.json sidecar; write_results_json() works without Pandoc.
• validate_cohort() - one entry point that wires connection, all modules, and the report. Accepts an open con or PostgreSQL connection arguments; concept_ids enables Module 1, comparator_id enables Module 4.

Notes

• Targets OMOP CDM v5.3.1. Validated against MIMIC-IV on PostgreSQL and a synthetic DuckDB mock used by the test suite.
• No dependency on CohortDiagnostics, DataQualityDashboard, or Achilles.
• All thresholds are documented, configurable function arguments.

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.