Implementierungsleitfaden Therapieziele Onkologie
1.0.0-ballot - Ballot Germany

Implementierungsleitfaden Therapieziele Onkologie - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Behandlungsepisoden (EpisodeOfCare)

This page includes translations from the original source language in which the guide was authored. Information on these translations and instructions on how to provide feedback on the translations can be found here.

An oncological course consists of bounded phases of activity — diagnostics, lines of therapy, surgery, surveillance, aftercare. Each is modelled as a care episode based on FHIR EpisodeOfCare: a bounded period of actively managed care with its own purpose (intent), period, status/history and responsible organisation.

One profile, many types

Rather than one profile per phase type, there is one general care-episode profile; the type is coded on EpisodeOfCare.type (open/extensible): diagnostic line, systemic line of therapy, locoregional treatment line, active surveillance / watchful waiting, aftercare. The list is open (e.g. induction/consolidation/maintenance for haematological disease).

Behandlungsepisoden: ein Profil, drei Spuren — führende Linie und ausführendes Segment Zeitstrahl mit Behandlungsepisoden in drei Spuren. Systemische Spur: die fuehrende Episode der Linie (neoadjuvant, traegt die EnLiST-Designation eLoT 1.0 samt lineId) und das ausfuehrende adjuvante Segment (ambulant, gleiche lineId, keine eigene Designation), verkettet ueber die lineId. Lokoregionale Spur: die perioperative Episode (not-counted, zeitlich ueberlappend; die OP selbst ist ein Procedure). Informative Spur: die Diagnostiklinie. Die Klammer des kurativen Gesamtkonzepts bilden Ziel und Plan, keine Episode. Ein Profil — viele Arten: EpisodeOfCare.type unterscheidet, die Struktur bleibt gleich. kuratives Gesamtkonzept — Klammer: Ziel + Plan (keine Episode) systemisch EnLiST — zählt (LoT) lokoregional im EnLiST-Framework nicht mitgezählt informativ / Management gemeinsame lineId Systemische Linie — führend neoadjuvant · stationär (Klinik) trägt Designation + lineId eLoT 1.0 Adjuvantes Segment ambulant · Pembrolizumab keine eigene Designation Perioperative Episode OP = Procedure not-counted · überlappt Diagnostiklinie type: Diagnostik Zeit Perioperative Episode = die Reise (Planung → OP → Reha); die OP selbst ist ein Procedure, einzelne Kontakte sind Encounter. In die LoT-Zählung (EnLiST) gehen nur Träger von enlist-lot ein — lokoregionale Linien und Segmente zählen nicht (mit). Die führende Episode trägt die Designation (eLoT 1.0 + lineId); ausführende Segmente verketten sich über dieselbe lineId. Behandlungsepisode (EpisodeOfCare — ein Profil) Designation Procedure lineId-Verkettung

Systemic line of therapy vs. locoregional treatment line

The umbrella term treatment line has two modality classes: the systemic line of therapy (LoT) follows the EnLiST consensus notation (Saini et al., Ann Oncol 2026) and is counted; the locoregional treatment line (surgery, radiotherapy, ablation) is not covered by EnLiST and not counted — a separate modality track.

Note on EnLiST. EnLiST standardises line designation for solid tumours and systemic therapy only; haematological disease uses a separate adaptation, and the framework is still in "road testing" (2026–2027). The LoT count is therefore not a universal cross-entity score; read the "counted?" column in the context of the entity.

Line change ≠ goal change

EnLiST designates lines as X.Y per setting axis (eLoT early · aLoT advanced · iLoT investigational, counted separately): X counts new LoTs (only on progression or lack of adequate response), Y counts modified LoTs (non-progression-related changes); same LoTs (prospectively planned changes including maintenance) leave the designation unchanged. These events live on the measures axis — they never trigger a goal operation automatically:

EnLiST event Trigger Episode goal Overarching goal
Same LoT (X.Y unchanged) prospectively planned: dose, pause, maintenance unchanged — or successor when a phase goal is achieved unchanged
Modified LoT (Y+1) intolerance, agent switch without progression unchanged (only the measure changes) unchanged
New LoT (X+1) progression / lack of response usually new — previous goal closed, often not-achieved unchanged while the intent holds
New LoT + strategy change (often eLoT→aLoT) progression invalidates the intent new replacement

Evidence in both directions: in the mCRC scenario the overarching goal outlives several palliative lines; induction → maintenance is a goal change without a line change (maintenance = same LoT); an agent switch for intolerance (eLoT 1.0 → 1.1) changes no goal at all. EnLiST also explicitly decouples setting and intent.

One line across organisations — leadership and execution

EpisodeOfCare is bound to an organisation. A line of therapy that runs across sectors (inpatient neoadjuvant systemic therapy → ambulatory adjuvant pembrolizumab) therefore splits into several episodes — without losing its identity: the leading episode (main contributor, typically the coordinating tumor centre) carries the EnLiST designation (enlist-lot) with a shared lineId — exactly once per line; executing organisations document their own episodes autonomously and mark them as segments (enlist-line-segment) with the same lineId, without a designation of their own. With the same site and sector, leadership and execution coincide in a single episode (the normal case); the documenting party chooses the form — no automatism. Counting stays trivial: only carriers of enlist-lot are counted.

Connecting encounters (ISiK/KBV) and MII procedures

If the proposed line-of-therapy modelling meets approval, it becomes the docking point in both directions: encounters from hospital care (ISiK) and ambulatory care (KBV) attach via the standard element Encounter.episodeOfCare; the MII procedures with performedPeriod — systemic therapy, radiotherapy and surgery — remain unchanged and are wired via the standard extension workflow-episodeOfCare, or, in an MII-only path, carry enlist-lot/enlist-line-segment directly. This yields the continuous chain encounter → segment/episode → line (LoT) → goal.

Episode ≠ procedure ≠ encounter

The surgery itself is a Procedure; the perioperative journey (planning, consent, the operation, post-op stay, rehabilitation, monitoring) spans several Encounters and is the episode. Care episodes link to the treatment plan via the workflow-episodeOfCare extension; Encounter itself is out of scope of this guide.