MII IG PRO
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide PRO (v2027.0.0-ballot.1: 2027 Ballot 5) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

PROMIS-16

Overview

Status: implemented — all 16 items, without score calculation Version: 2026.5.0 As of: 2026-06-10

The PROMIS-16 Profile v1.0 is an ultra-short multi-domain instrument for assessing health-related quality of life (HRQoL). With only 16 items across 8 domains (2 items per domain) it is considerably shorter than the PROMIS-29 and suited to settings with a high assessment burden — repeated measurement over a clinical course, for instance, or use as a screening instrument.

Source: Edelen et al. 2024 – PROMIS®-16: development and preliminary psychometric evaluation (Qual Life Res, doi:10.1007/s11136-023-03597-6)

Domains Covered

Domain Items PCOR-MII variable IDs
Physical Function 2 PFA21, PFA23
Anxiety 2 EDANX40, EDANX41
Depression 2 EDDEP29, EDDEP41
Fatigue 2 HI7, AN3
Sleep Disturbance 2 SLEEP25, SLEEP90
Social Roles & Activities 2 SRPPER31_CaPS, SRPPER46_CaPS
Pain Interference 2 PAININ9, PAININ31
Cognitive Function 2 PC27, PC-CaPS3R

Technical Details

Questionnaire Resource

Questionnaire/mii-qst-pro-promis-16

Capabilities:

  • Displayable
  • Collectable
  • Extractable
  • Domain-aligned
  • Calculatable: deliberately false — the pattern-based T-score lookup per domain (5×5 = 25 values from supplement S4 of Edelen et al.) is realised through a dedicated CQL library mii-lib-promis-16 (analogous to the architecture for PHQ-9 and EQ-5D)

Score Calculation (not implemented in this version)

PROMIS-16 is properly "PROMIS-16 Profile v2.1 (PROPr)" and is designed for computing the PROMIS preference score (PROPr) — a single utility score (analogous to the EQ-5D index) used in comparative effectiveness and cost-utility analyses. The full score calculation proceeds in three stages:

  1. 8 domain T-scores — per domain from a 5×5 response-pattern grid (25 combinations, pattern lookup per Edelen et al. 2024 supplement S4)
  2. PROMIS theta values — IRT-based latent constructs per domain
  3. PROPr summary score — utility-based, derived from the 8 thetas (Dewitt et al. 2018)

In the current version (2026.5.0) the score calculation is deliberately not implemented. The questionnaire accordingly carries calculatable = false and serves purely for data capture for now. Score calculation is to be added later via a CQL library mii-lib-promis-16 and/or a connection to the official PROMIS Assessment Center API, once the internal requirements are settled.

Note on intended use (per PHO): the PROPr score is intended for group-level reporting. For precise individual clinical assessment, domain scores alone are not reliable according to PHO — they can, however, serve as a screen.

Score methodology reference: Dewitt B, Feeny D, Fischhoff B, et al. Estimation of a Preference-Based Summary Score for PROMIS: The PROMIS®-Preference (PROPr) Scoring System. Med Decis Making. 2018;38(6):683-698. doi:10.1177/0272989X18776637

Language Support

Primary language: English (the validated original) German translation: via the translation extension; wordings from the PCOR-MII Master Item-Level Dictionary (curated by CPCOR Charité — see Licensing below)

Implementation Status

All 16 items are implemented in input/fsh/definitions/promis-16/mii-qst-pro-promis-16.fsh with the official wordings from the PHO PDF "PROMIS-16 Profile v2.1 (PROPr), German, 20 September 2024". The wordings were verified automatically against the PCOR-MII Master Item-Level Dictionary (MATCH=15, DIFF=0).

The five PROMIS-16-specific LOINC codes (Sleep25, Sleep90, SRPPER31-CaPS, PC27r, PC-CaPS3r) are marked TODO in the FSH file — they must still be verified against the official LOINC list once the PROMIS-16 panel codes are published in LOINC.

Score calculation (PROPr + domain T-scores) is deliberately not implemented in this version — see the section Score Calculation.

Item Overlap with PROMIS-29 / Cog Fn SF 4a

11 of the 16 PROMIS-16 items also appear in the PROMIS-29 corpus, 5 are PROMIS-16-specific:

PROMIS-16 item Also in PROMIS-29? Also in Cog Fn SF 4a?
PFA21, PFA23 ✓ –
EDANX40, EDANX41 ✓ –
EDDEP29, EDDEP41 ✓ –
HI7, AN3 ✓ –
Sleep25 – –
Sleep90 – –
SRPPER31_CaPS – –
SRPPER46_CaPS ✓ –
PAININ9, PAININ31 ✓ –
PC27r – – (4a has different PC items)
PC-CaPS3r – –

Practical consequence: anyone collecting PROMIS-29 + Cog Fn SF 4a cannot extract a complete PROMIS-16 — the five items in bold are missing. A score-level cross-walk between PROMIS-16 and PROMIS-29 domain T-scores is the subject of later work packages (roadmap, together with the score implementation).

PROMIS-16 vs. PROMIS-29

Aspect PROMIS-16 PROMIS-29
Total items 16 29 (28 Likert + 1 NRS)
Items per domain 2 4
Domains covered 8 (incl. Cognitive Function) 7 + 1 NRS (no Cognitive Function)
Score method Pattern lookup (25 per domain) Sum score + T-score lookup
Completion time ~3-5 min ~7-10 min
Context of use Repeated measurement, screening Detailed baseline assessment

PROMIS items are protected by copyright. The official German translations are provided by PCOR-MII and curated by the PROMIS National Center Germany (CPCOR Charité, led by Felix Fischer).

For institutional implementation outside the PCOR-MII context, a usage request to CPCOR is required: https://cpcor.charite.de/promis_national_center_deutschland/nutzungsanfragen

For details of the layered attribution (MII FHIR structure + PROMIS items + German translation + LOINC) see PROMIS — Licensing & Copyright.

References