Index and Score Operationalization Checklist for RWE

What it is

- This guideline is the checklist layer for source-backed indices, scores, and code groupers used in RWE. Concepts explain what Charlson, Quan-Charlson, Elixhauser, CMS-HCC, NCI comorbidity, AHRQ CCS/CCSR, ECOG, and related scores are; this guideline states what must be specified, archived, and reported when one of those derived variables is used in a protocol, SAP, manuscript, payer dossier, or regulatory appendix. It is intentionally separate from the concept files because checklists belong in guideline records, while concept records carry the operational method.

When to use

- Use it whenever an index, score, risk-adjustment model, code grouper, or clinical scale becomes an analytic variable rather than a topic label. Typical uses include a Quan-Charlson baseline comorbidity score in claims, a CMS-HCC risk score in Medicare Advantage or payer work, an AHRQ CCS/CCSR grouping used to collapse diagnoses, an NCI comorbidity score in SEER-Medicare oncology cohorts, or ECOG performance status abstracted from EHR/registry data. Apply it before data derivation starts, because version, lookback, source-field, and hierarchy choices change the numeric output and can change effect estimates.

What it requires / checklist domains

- The common failure mode is under-specification: "Charlson," "HCC," "CCSR," or "ECOG" is not enough. A reproducible report names the exact index or grouper family, version or release, source data fields, code maps, diagnosis/procedure positions, assessment window, hierarchy rules, coefficient or point set, missingness handling, and intended analytic role. The checklist also requires source-backed definitions for each component or category when a table of index definitions is shown. For payment or administrative models such as CMS-HCC, report the model year and do not mix risk-adjustment and causal confounding language. For clinical scores such as ECOG, report timing relative to index date and whether the value came from structured fields, abstraction, NLP, registry capture, or imputation.

When NOT to use - limitations and common misapplications

- Do not use this checklist as a claim that the score is clinically valid in the current population. It verifies operational transparency, not predictive performance, calibration, construct validity, or causal adequacy. Do not substitute a payment model for a clinical severity measure without labeling the limitation. Do not compare scores across studies if versions, lookback windows, code systems, or component hierarchies differ. Do not present area, payer, or registry proxies as individual clinical facts. It is actively misleading to say "Quan-Charlson adjusted" if the implementation used a different ICD map, omitted hierarchy rules, mixed ICD-9 and ICD-10 without a transition plan, or derived comorbidities during follow-up.

How it maps to this catalog

- This guideline cross-references the implementing concepts: `charlson-comorbidity-index-rwe` for Charlson and Quan administrative maps, `elixhauser-comorbidity-index-rwe` for Elixhauser indicators, `cms-hcc-risk-adjustment-rwe` for CMS-HCC model-year handling, `nci-comorbidity-index-seer-medicare-rwe` for SEER-Medicare oncology comorbidity, `ahrq-ccs-ccsr-clinical-classifications-rwe` for AHRQ diagnosis grouping, and `ecog-performance-status-score-rwe` for oncology performance status. Use STaRT-RWE or RECORD-PE for the broader study report; use this checklist for the index-specific derivation table and reproducibility appendix.