This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) 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

Guidance for Researchers

Guidance for Researchers

Guidance for researchers using the data of the Molecular Tumor Board module for research purposes — e.g. which data elements are relevant to which research questions, and how they are to be interpreted.

Outcome endpoints: OS, PFS and time to next treatment

The module's follow-up documentation is designed so that the standard real-world oncology endpoints can be derived from routine data. The reference point (t₀) for all three is typically the start of the MTB-recommended therapy (SystemischeTherapie.performedPeriod.start); depending on the research question, the MTB decision date (Therapieplan) can serve as an alternative index date.

Overall survival (OS) — time from t₀ to death from any cause. Death and its date come from Patient.deceasedDateTime (MII Person module); in addition, the Person module's Vitalstatus observation carries the vital status per contact date, and the Oncology module's Tod observation documents death date, cause of death and its tumor relation — use them to confirm the event and, for cause-specific analyses, to distinguish tumor-related deaths. Patients without a death record are censored at their last documented contact (most recently dated Follow-Up ClinicalImpression, Response-Befund or therapy documentation).

Progression-free survival (PFS) — time from t₀ to the first documented progression or death, whichever comes first. Progression is read from the Response-Befund: a RECIST/iRECIST assessment of progressive disease (PD) in valueCodeableConcept, with effectiveDateTime as the event date and the assessment method (RECIST, RANO, clinical) in the profile's method element. Response findings are tied to their therapy via partOf, so PFS is computed per therapy line, not per patient alone.

Time to next treatment (TTNT) — time from t₀ to the start of the next systemic therapy line (performedPeriod.start of the following SystemischeTherapie, or the first MedicationStatement of the next line); patients without a subsequent line are censored at last contact. TTNT is the robust real-world surrogate when imaging-based progression assessment is incompletely documented — in this module's data it needs no imaging at all, only the therapy sequence, and the reason a line ended is available in the therapy's status reason (mii-cs-mtb-therapiestatusgrund / statusReason) and, for non-implementation of a recommendation, in the Follow-Up's Grund Nicht-Umsetzung coding.

Practical notes: therapy lines are ordered by performedPeriod; the Leitliniendokumentation extension on prior therapies carries the line number (Therapielinie) where documented. Cost-coverage delays (visible as the span between Antrag and Antwort Kostenübernahme) can systematically shift t₀ and are themselves a researchable quantity.