Methods & Technology

The complete path from a research question to decision-grade evidence — standardized, distributed and reproducible.

The pipeline

Eight steps, one consistent framework

STEP 01Research QuestionTranslate clinical, policy or regulatory questions into population, exposure, comparator, outcome and time-zero.
STEP 02Feasibility & Fit-for-purposeAssess data suitability for the specific question — no full database conversion required up front.
STEP 03Protocol & Variable DefinitionCommon protocol, SAP, code lists, variable specifications and output formats.
STEP 04Standardization & CDMOMOP, Sentinel-like or other standardized structures — one common analytical interface.
STEP 05Quality ValidationStructural conformance, plausibility, cohort & variable validation, analytical consistency.
STEP 06Distributed ExecutionPartners run common programs locally; only aggregate results return.
STEP 07Evidence IntegrationCombine and explain results across countries.
STEP 08Visualization & InterpretationComparable, decision-ready presentation — read in context.

Steps 1–6 cover technical preparation and study execution; steps 7–8 focus on evidence communication. When a study uses a common protocol rather than a full CDM approach, the extent of data conversion can be adjusted — but common definitions and quality standards are always maintained.

The distributed data network

Three levels of collaboration

Raw data stay behind each site's firewall; every site analyzes locally and shares only permitted aggregate results. What varies is how much is shared consistently across sites.

L1

Common question

Every site answers the same research question, but analyzes it according to its own understanding of the data and methods. Greatest flexibility — and the greatest variation in implementation.

L2

Common protocol

Design, eligibility criteria, variable definitions and statistical methods are specified in advance; each site writes its own programs. The research logic is standardized — but the same written instructions can still be interpreted differently.

L3

Common data model + common code

Each site first transforms its data into a consistent structure, then executes the same programs from the coordinating center. Implementation differences are minimized and analytical modules become reusable. This is IMPRESIVE's core.

Why a common protocol alone is not enough. In a published reproducibility study, 54 researchers in nine teams were asked to reconstruct the same study population from the same dataset, article and supplementary materials — in parallel with the original authors. The eligible populations they identified differed substantially and did not fully overlap. Even with identical data and descriptions, eligibility criteria, time windows, variables and programming logic are interpreted differently. Standardizing the data structure and the analytical code — not just the protocol — is how IMPRESIVE reduces irreproducibility caused by human interpretation.

Different bricks, different countries

The IMPRESIVE build

Every partner country brings its own set of bricks — different shapes, different colours. IMPRESIVE clicks them together into one shared build.

Raw data from different countries shown as assorted LEGO bricks — Taiwan (blue), Japan (pink), Korea (green), United States (orange) and Europe (purple), each a different shape and colour.
Raw data from each country arrives as different bricks — ready to be standardized and built together.

The common data model

Different bricks, one shared model

Every country's data starts as differently shaped bricks. Standardization clicks them into one common data model — so they stack into a single, comparable build.

The Common Data Model shown as LEGO bricks: raw-data bricks from Taiwan, Japan, Korea, the United States and Europe pass through a standardization pipeline (standardization, structuring, harmonization) to become the standardized CDM, then stack into a castle. Flow at the bottom: Raw Data, Standardization, Structuring, Harmonization, CDM, Better Castle.
From raw, mismatched data to a common data model — and a stronger, shared build.
1
Raw data

Each country brings claims or EHR data in different formats and code systems.

2
Standardization

Variables, diagnoses and drugs mapped to shared definitions.

3
Structuring

Reshaped into one common table structure.

4
Harmonization

The same meaning everywhere, so results are comparable.

5
CDM

One common data model a single analytic program can run on.

6
Better build

Countries stack into integrated, decision-ready evidence.

Practical experience

OMOP and Sentinel-like CDMs — hands-on, in Asia

IMPRESIVE has implemented both. Neither is universally superior — the right choice depends on data governance, local coding systems, the research purpose and the team.

OMOP CDM

  • Maintained by the OHDSI community
  • Standardizes both structure and semantic vocabularies — ICD, SNOMED and local codes are mapped to standard concepts
  • Promotes semantic consistency across countries
  • Asian settings often use government- or institution-specific codes with no existing crosswalk — customized mapping tables must be built and maintained by people who know the data and clinical context

Sentinel-like CDM

  • Originated from the US FDA's active safety-surveillance system
  • Emphasizes structural standardization while retaining more original source terminology
  • Vocabulary differences are managed through study definitions and site-level code lists
  • Could be implemented directly inside restricted data centers using familiar SAS programs — often a lower implementation cost in Taiwanese and other Asian data environments

Working inside a restricted data center

Taiwan's NHIRD sits in a highly controlled data center with no external access. The team first built dummy data with the same structure but no real personal information, developed and verified the transformation programs, vocabulary mappings and QA externally — then brought the validated programs into the data center for execution.

A CDM is not immutable

When the original Sentinel design could not fully represent drug-dose information needed for a study, the team added a documented, validated, version-controlled drug-dose table built on the concept of drug strength. Other local adaptations followed the same discipline: missing discharge dates derived from length of stay, and Taiwan NHI drug codes mapped through ATC for OMOP. Extending a model to meet a clinical question — with proper documentation — is itself a methodological contribution.

Getting the transformation right

Data inventory, ETL and quality assurance

The first step is not programming — it is understanding what each source database contains and which fields the intended study genuinely requires.

🟢🟡🔴 Feasibility inventory

Each required element is classified before transformation: green — available and directly transformable; yellow — obtainable through derivation rules or additional processing; red — not directly available, requiring assumptions or unsupported. Temporal granularity matters too: monthly-level versus exact-date diagnoses directly change exposure windows and outcome ascertainment.

The ETL specification

A detailed "transformation recipe" documenting how every source field converts to its target table and field — written before implementation in SAS, R or other local tools. It is a formal document supporting cross-country communication, reproducibility, updating and auditing — never undocumented knowledge held by one researcher.

Three-dimension quality checks

Conformance — structures, formats and permitted values follow the CDM spec. Completeness — no information lost in transfer. Plausibility — dates, values and clinical distributions are reasonable and consistent with the source. For OMOP, the official Data Quality Dashboard runs 3,000+ automated checks; for the Sentinel-like CDM the team built its own quality checks, comparing native and CDM results with a 5% difference threshold.

Beyond field formats. The team also identifies study-relevant populations and compares annual and monthly patient and event counts between source and CDM. When something looks wrong, the cause is traced — shared analytical package, site-specific ETL program, execution inside the data center, or the source data itself — then revised and rerun in an iterative cycle. Anomalies that already exist in the source (for example, disease records inconsistent with recorded sex) are handled through case definitions and validation algorithms, not misclassified as ETL errors. CDM quality assurance ensures the transformation neither introduced nor lost information; the clinical plausibility of the source itself is a separate layer of data quality.

In depth

How each capability works

1 · Question Formulation

We help translate clinical, policy or industry problems into executable research questions. A topic well-suited to IMPRESIVE has:

  • A clear disease or treatment decision need
  • A well-defined target population
  • Explicit exposure, comparator and outcome
  • A definable time-zero
  • Genuine comparative value across countries
  • Clinical, policy, regulatory or industry significance
2 · Database Standardization

Different national data structures are standardized to a common format and shared variable definitions so a single analytic program can run everywhere. This includes:

  • Source data profiling
  • Variable mapping
  • Diagnosis code mapping
  • Drug code mapping
  • Procedure code mapping
  • Outcome definition mapping
  • Data quality check
  • Fit-for-purpose assessment
3 · CDM Conversion

A common data model — OMOP, Sentinel-like or another standardized structure — lets different databases support multi-country analysis through one common analytical interface, while keeping local data governance fully intact. Quality validation covers structural conformance, plausibility, cohort and variable validation, and analytical consistency.

4 · Analysis Modules

Reusable, standardized analysis modules:

  • Cohort study module
  • Target trial emulation module
  • Self-controlled design module
  • Negative control module
  • Transportability module
  • Disease burden module
  • Treatment pattern module
  • Meta-analysis module
  • Evidence synthesis module
5 · Distributed Analytics

Individual-level raw data never leaves each country's data center. What IMPRESIVE shares is the common protocol, standardized analytic code, data-quality diagnostic reports and aggregated statistical results.

6 · Evidence Integration

Integration is more than a pooled estimate — it is understanding why results are the same, different, or not comparable across countries:

  • Country-specific estimates
  • Heterogeneity assessment
  • Random-effects meta-analysis
  • Sensitivity analysis
  • Subgroup analysis
  • Negative control interpretation
  • Transportability assessment
  • Contextual interpretation
7 · Results Visualization

Visualization tools turn cross-national results into forms that are easy to understand and compare:

  • Database readiness dashboard
  • Country-level result dashboard
  • Treatment pattern visualization
  • Disease burden visualization
  • Forest plots
  • Trend plots
  • Heterogeneity visualization
  • Evidence-to-decision summary dashboard

See the readiness dashboard preview →

8 · Evidence-to-Decision

The goal is not analysis for its own sake, but support for decisions — integrating statistical results, method credibility, data fitness, clinical meaning and a decision recommendation.

"Evidence is not the end of analysis; it is the beginning of decision."