# RWE phenotype and code-list validation evidence matrix

> **Editorial worksheet, not a validated phenotype or an official reporting
> form.** Use one matrix per exposure, outcome, eligibility criterion, or key
> covariate. A filled matrix records why an algorithm is appropriate for a
> particular source and era; it does not transport performance from another
> population automatically.

**Study / protocol ID:** [enter]  
**Variable / concept:** [enter]  
**Role:** [eligibility / exposure / comparator / outcome / covariate]  
**Data source and era:** [enter]  
**Owner / version / date:** [enter]

## 1. Operational definition

| Component | Pre-specified rule | Data provenance | Rationale / citation |
|---|---|---|---|
| Code systems and versions | [ICD, SNOMED, CPT, NDC, local term, version] | [table/feed] | [enter] |
| Required events | [e.g., 1 inpatient or 2 outpatient events] | [enter] | [enter] |
| Time window | [enter] | [enter] | [enter] |
| Position / setting qualifiers | [primary diagnosis, inpatient, ED, etc.] | [enter] | [enter] |
| Exclusions / competing conditions | [enter] | [enter] | [enter] |
| Indexing and episode rules | [first event, washout, recurrence handling] | [enter] | [enter] |

**Versioned code-list location:** [repository/appendix/version ID]  
**Reproducible build query or program:** [location and commit/version]

## 2. Validation and transportability evidence

| Evidence source | Population and setting | Reference standard | Performance measure | Estimate (95% CI if available) | Match to this study | Limitation / action |
|---|---|---|---|---|---|---|
| [published validation] | [enter] | [chart review/adjudication/etc.] | [PPV, sensitivity, etc.] | [enter] | [high/moderate/low] | [enter] |
| [internal validation] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] |
| [feasibility review] | [enter] | [enter] | [enter] | [enter] | [enter] | [enter] |

## 3. Empirical quality checks in this study

| Check | Expected result | Observed result | Interpretation | Decision / owner |
|---|---|---|---|---|
| Event chronology | [enter] | [enter] | [enter] | [enter] |
| Prevalence/incidence plausibility | [enter comparator] | [enter] | [enter] | [enter] |
| Duplicate/near-duplicate events | [enter] | [enter] | [enter] | [enter] |
| Source or era drift | [enter] | [enter] | [enter] | [enter] |
| Manual or adjudication sample | [sampling frame and n] | [enter] | [enter] | [enter] |

## 4. Decision and traceability

**Algorithm status:** [approved / approved with restrictions / revise / not fit]  
**Sensitivity analyses triggered:** [alternate algorithm, lag/window, setting rule, quantitative bias analysis]  
**Protocol/SAP and output locations updated:** [enter]  
**Approver / date:** [enter]

## Source basis

- U.S. Food and Drug Administration. *Real-World Data: Assessing Electronic
  Health Records and Medical Claims Data To Support Regulatory Decision-Making
  for Drug and Biological Products*. Guidance for Industry, July 2024.
  https://www.fda.gov/media/152503/download
- Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for
  planning and reporting on the implementation of real world evidence studies.
  *BMJ*. 2021;372:m4856. https://doi.org/10.1136/bmj.m4856
- Langan SM, Schmidt SAJ, Wing K, et al. The reporting of studies conducted
  using observational routinely collected health data statement for
  pharmacoepidemiology (RECORD-PE). *BMJ*. 2018;363:k3532.
  https://doi.org/10.1136/bmj.k3532