annotation_guideline_v1.2.md

# GraSCCo Treatment-Status — Annotation Guideline (v1.2)

> **Status: frozen for release.** Incorporates clinical review and the κ-adjudication pass
> (binary/safety definition in §2 unchanged). Once frozen, do not edit mid-labeling; log any
> change as a new version with a timestamp.
>
> **Changes from v1.0 (clinical review):** (1) "given" redefined as *current* administration/
> continuation at time of documentation, resolving the PAUSED/STOPPED inconsistency;
> (2) verb test split by tense (weiterführen/fortsetzen/eingenommen no longer auto-given);
> (3) WITHHELD vs PAUSED disambiguation for "zurückgehalten"; (4) STOPPED "ex" vs HISTORICAL
> disambiguation; (5) CONTINUED-active extended to pumps/patches + continuation-language
> overrides heading; (6) κ section: human clinician required as second annotator, sized to corpus.

---

## 0. What you are doing

For every **treatment or medication mention** in a GraSCCo letter, assign **one
leaf label** (Section 1) and **one or more phenomenon tags** (Section 7).

- **The safety question behind every decision:** *Does this note assert that the
  drug/treatment is **currently** being administered or performed — now, in this
  encounter/treatment episode at the time of writing?*
  If yes → it collapses to **given**. If it was only planned, discussed, refused,
  withheld, paused, stopped, historical, or merely listed → **not given**.
- **Unit of analysis = the mention** (a drug or procedure), **not the sentence**.
  Your evidence window is the enclosing line/clause, plus the adjacent sentence
  when the status is only settled later (cross-sentence; Section 6c).
- **You are correcting a pre-fill.** The CSV already has a *provisional* leaf from
  a heuristic. It is a starting point, not truth — especially WITHHELD (Section 6b).
  Re-read every mention and fix it.

---

## 1. The label set (9 leaves) and how they collapse

You assign the **leaf**. The binary and the 6-class are derived automatically — you
never assign them, but they are shown so you understand the consequence of a leaf.

| Leaf | Definition | Binary | 6-class |
|---|---|---|---|
| **GIVEN** | Administered/performed in this episode (explicit) | given | GIVEN |
| **CONTINUED-active** | Home/long-term med the note asserts is being **taken/continued now** | given | GIVEN |
| **PLANNED** | Intended/ordered, not yet executed (incl. discharge plan, PRN order) | not given | PLANNED |
| **DISCUSSED** | Talked about / counseled / recommended; no action taken | not given | DISCUSSED |
| **REFUSED** | Patient declined (after offer/recommendation) | not given | REFUSED |
| **WITHHELD/CONTRAINDICATED** | Clinician decided not to start (contraindication, allergy, "Cave", "kein X") | not given | WITHHELD |
| **PAUSED** | Temporarily held/suspended ("pausiert") | not given | WITHHELD |
| **STOPPED** | Previously given, now discontinued ("abgesetzt", "ex") | not given | WITHHELD |
| **HISTORICAL** | Prior-episode administration / "Z. n." / background-only list entry | not given | HISTORICAL |

Plus one non-label outcome:

| **DROP / not-a-treatment** | Not a treatment mention at all (lab value, radiology finding, exam, bare diagnosis) | — | — |

---

## 2. The binary collapse rule (the core definition)

- **given** = the note asserts the drug/treatment is **currently** being administered
  or performed in this encounter or treatment episode (at the time of documentation),
  **or** a home med is being **actively continued/taken now** in the current care context.
- **not given** = everything else: planned, discussed, refused, withheld, contraindicated,
  paused, stopped, historical ("Z. n."), or merely listed.

**Important (resolves the PAUSED/STOPPED case):** "given" means *current* administration
status, **not** "ever given during the episode." A drug labeled **PAUSED** or **STOPPED**
is **not given** in the binary, even if it was administered earlier in this episode —
because the model error we are hunting is a *current* false administration (e.g. calling
a discontinued drug "currently given").

Per CMO ruling: **historical "Z. n." and background medication lists are NOT given.**

---

## 3. Decision procedure (apply in this order)

1. **Is it actually a treatment/medication mention?**
   No → **DROP** (Section 6b/6h). Yes → continue.
2. **Explicit status trigger present?** (refused, pausiert, abgesetzt, Z. n.,
   bei Bedarf, Cave/kein-+drug, geplant/besprochen, falls…, frustran)
   → assign that leaf. (Triggers override the heading.)
3. **Under a routed section heading?** (Section 4) → apply the heading default.
4. **Verb test** (Section 3a) → GIVEN vs not given.
5. **Still unclear?** → use episode-scoping judgment; if genuinely undecidable,
   default **not given** and flag the row for adjudication.

### 3a. Verb test (fallback for prose and the ambiguous heading)
Tense and framing decide direction — bare "continuation" words are **not** automatically given.
- **→ given (current administration / active continuation):** erhielt · bekam · appliziert ·
  verabreicht · umgestellt auf · begonnen mit · **wurde fortgeführt** · **nimmt (weiter) ein**
- **→ not given (forward-looking / plan):** soll · geplant · empfohlen ·
  **soll weitergeführt/fortgesetzt werden** · **für zuhause fortführen** · **bei Entlassung fortsetzen**
- **Watch:** bare **"eingenommen"** alone can be a historical self-report — it triggers given
  only when anchored to current intake ("nimmt ein", "weiter eingenommen", "wurde fortgeführt").
  Bare **"weiterführen / fortsetzen"** without "wurde/nimmt" leans PLANNED, not given.

---

## 4. Section-heading routing (locked)

The heading often settles the label before you read the line.

| Heading (+ synonyms) | Default | Leaf |
|---|---|---|
| Vormedikation · Aufnahmemedikation · Medikation bei Aufnahme · Hausmedikation · Dauermedikation · Heimmedikation · Bisherige Medikation | **not given** | HISTORICAL/background |
| Entlassmedikation · Austrittsmedikation · Entlassrezept · Medikation zur/bei Entlassung · Therapieempfehlung · Medikationsempfehlung | **not given** | PLANNED (forward-looking) |
| Therapie während des Aufenthalts · Im Verlauf erhielt · Stationäre Medikation · Medikation auf Normalstation | **given** | GIVEN |
| Notfallmedikation · Intraoperative Medikation · Prämedikation | **given** | GIVEN |
| Abgesetzte Medikation | **not given** | STOPPED |
| Pausierte Medikation | **not given** | PAUSED |
| Bedarfsmedikation (PRN) | **not given** unless an administration is documented | PLANNED + PRN tag |
| **Aktuelle Medikation · Aktueller Medikamentenplan · Medikation bei Verlegung** | **line-by-line** (verb test) — *do NOT auto-call given* | by verb test |

> The last row is the validated-ambiguous case: in this corpus these headings carried
> **no administration verb** in 48/48 occurrences, so they are decided by the line
> text, not the heading.

---

## 5. Per-leaf detail with German examples

**GIVEN** — *"Die Patientin **erhielt** eine Therapie mit Kortikosteroiden i.v."* ·
*"… 2000 ml NaCl 0,9 % **verabreicht**."* → administration carried out now.

**CONTINUED-active** — *"Die Hausmedikation mit Ramipril 5 mg wurde unverändert
**fortgeführt**."* → continuation asserted → given. (Compare HISTORICAL below.)
*Also CONTINUED-active:* continuous-delivery meds the patient **arrived on and keeps
receiving** during the encounter (insulin pump, fentanyl/opioid patch, ongoing infusion),
even without a "fortgeführt" verb — delivery is active now.

**PLANNED** — *"Procedere: Eine Rektumamputation **wäre vorgesehen**."* ·
*"Entlassmedikation: Bisoprolol 2,5 mg (**Fortführung empfohlen**)."* → intended, not done.

**DISCUSSED** — *"Im Tumorboard **besprochen**, **empfohlen** wird …"* → counseled, no action.

**REFUSED** — *"Patient **verweigert** die Bluttransfusion (g. ä. R.)."* → patient declined.
Add the **AMA modifier** when "gegen ärztlichen Rat / Revers" (Section 8).

**WITHHELD/CONTRAINDICATED** — *"**Cave** Penicillin."* · *"Auf eine Antibiose wurde
**verzichtet**."* · *"ACE-Hemmer bei Niereninsuffizienz **zurückgehalten**."* → clinician
did not start it. ⚠ Only when a real drug is named (Section 6b).
*Disambiguation:* **"zurückgehalten"** is ambiguous — if an ongoing med is *temporarily held
with expected resumption*, use **PAUSED**; reserve **WITHHELD** for **not-started / deliberately
not given** (contraindication, allergy, risk, decision to refrain). An **allergy/known
intolerance** noted without a specific decision this episode still maps to WITHHELD/CONTRAINDICATED.

**PAUSED** — *"Metformin präoperativ **pausiert**."* · *"Enalapril 2,5 mg dzt **pausiert**."*

**STOPPED** — *"Ramipril **abgesetzt**."* · *"Marcumar **ex**."*
*Disambiguation:* **"ex"/abgesetzt = STOPPED** when it's part of a *current* med-status
statement (the drug was on the regimen and is now discontinued). If a prior therapy appears
only as **distant background exposure**, label **HISTORICAL** instead.

**HISTORICAL** — *"**Z. n.** Cortison-Stoßtherapie."* · *"14 Zyklen Raltritrexed
01/97–10/18"* (dated past therapy in a Diagnosen block). → prior episode, not now.

---

## 6. Special rules and traps

### 6a. Continued / home medication (Dauer-/Hausmedikation)
**Test:** does the note assert current intake or continuation in this episode?
**Yes** → CONTINUED-active (given). **No** (merely listed) → HISTORICAL/background (not given).
**Default / tie-breaker:** if no word asserts current intake or continuation → **not given**.
**Heading override:** explicit current-intake language beats the section heading — *"Patient
**nimmt** zu Hause Marcumar **ein**"* is CONTINUED-active (given) **even under a "Vormedikation"
heading**.

| German | Decider | Leaf | Binary |
|---|---|---|---|
| "Hausmedikation mit Ramipril 5 mg **fortgeführt**." | continuation verb | CONTINUED-active | given |
| "**Vormedikation bei Aufnahme:** Ramipril 5 mg 1-0-0, Metformin 1000 mg 1-0-1." | bare admission list | HISTORICAL | not given |
| "**Hausmedikation:** L-Thyroxin 75 µg." | no marker → default | HISTORICAL | not given |
| "Patient **nimmt** zu Hause Marcumar **ein**; im Verlauf **pausiert**, Bridging mit Enoxaparin." | later clause flips it | Marcumar → PAUSED; Enoxaparin → GIVEN | not given / given |

### 6b. The "kein = finding negation" trap (WITHHELD) ⚠ most common error
"kein/keine" and "Cave" only mean **WITHHELD** when they negate a **drug/treatment**.
When they negate a **finding** (radiology, lab, exam), the line is **not a treatment
mention at all → DROP**.

| German | Label |
|---|---|
| "**Keine** freie intraperitoneale Luft." | **DROP** (radiology finding) |
| "**Kein** Nachweis path. Lymphknoten." | **DROP** (radiology finding) |
| "**keine** Nebenwirkungen der Chemo." | **DROP** (this is a *result*, not a withheld drug) |
| "**Auf** eine Antibiose wurde **verzichtet**." | **WITHHELD** (real — a drug is withheld) |
| "**Kein** ASS bei Allergie." | **WITHHELD** (real — a drug is withheld) |

**Rule of thumb:** if removing the negation leaves no actual drug/therapy, it's a finding → DROP.

### 6c. Cross-sentence / propose-then-cancel
Label by the **final asserted status**, reading the next sentence/clause. Tag `cross-sentence`.
*"Beginn einer Antikoagulation geplant; **hiervon jedoch abgesehen** bei Blutungsrisiko."* → WITHHELD.

### 6d. Dated past therapies in Diagnosen / Anamnese blocks
A treatment with a **date** under a history heading (Diagnosen, Anamnese,
Zwischenanamnese, Verlauf der Tumorerkrankung) and **no present-administration verb**
→ **HISTORICAL**. These are the bulk of GraSCCo's oncology content.

### 6e. PRN / "bei Bedarf" / b. B.
A standing PRN order is **not given** (leaf PLANNED, tag `prn`) **unless** an actual
administration is documented (*"… b. B., **erhielt** 1×"*). Then GIVEN.

### 6f. "frustran"
Attempted but failed (e.g. *"PVK-Anlage **frustran**"*) → the intended drug was not
delivered → **not given** (leaf PLANNED, tag `frustran`).

### 6g. Over-split chemo regimens
The pre-fill splits multi-line protocols into fragments
(*"5-FU (2000 mg/m²)"*, *"Tag 1–14, Pause Tag 15–21"*). **Merge fragments back to the
parent regimen and label once.** Do not label schedule fragments separately.

### 6h. DROP / not-a-treatment
Drop lab values, radiology/sono/CT/MR findings, exam descriptions, vital signs, and
bare diagnoses with no associated treatment. Mark the row `DROP`; it leaves the eval set.

---

## 7. Phenomenon tagging (for the "where it breaks" breakdown)

In addition to the leaf, tag each mention with every phenomenon that applies (multi-tag):

`negation` · `refusal` · `discussion-only` · `cross-sentence` · `prn` · `paused` ·
`stopped` · `contraindication` · `historical` · `conditional` (falls…dann) · `frustran`

These drive the per-phenomenon accuracy and false-administration breakdown, so tag generously.

---

## 8. Modifiers

- **AMA** (against medical advice): set on **REFUSED** when "gegen ärztlichen Rat /
  g. ä. R. / Revers" appears. The leaf stays REFUSED; the modifier is recorded separately.

---

## 9. Quality process (κ)

1. Primary annotator labels the full set following this guideline.
2. **An independent, German-speaking *human* clinician** (not the primary annotator)
   labels **20–30%** of the items. An AI/model **cannot** serve as this rater — the
   benchmark exists to test AI on clinical text, so validating the gold with AI is circular
   and not defensible. (An AI pass may be reported separately as an *exploratory third signal*,
   never as the κ rater.)
   - Suitable rater: internist or oncologist, senior internal-medicine/oncology resident,
     or an oncology-savvy clinical pharmacist / documentation specialist.
3. **Sample size (this corpus):** ~500–600 labelable items → 20–30% ≈ **~120–180 mentions**
   double-labeled (a few hours of clinician time). Stratify to include the hard phenomena
   (home-med, WITHHELD, PAUSED, STOPPED, PRN, "kein" negation, cross-sentence) — oversample
   them, since rare leaves otherwise yield too few items for a stable κ.
4. Report **Cohen's κ per leaf** and for the **binary**. Targets: binary κ ≥ 0.8 (good);
   per-leaf 0.6–0.8 acceptable; a leaf < 0.6 signals the guideline is unclear there → issue a
   v1.x clarification before relying on that category. Expect home-med and WITHHELD to be weakest.
5. Adjudicate disagreements; record resolutions; then **freeze** the eval set. No further edits.

---

## 10. Quick-reference card

| If the mention says… | Leaf | Binary |
|---|---|---|
| erhielt / verabreicht / appliziert (this stay) | GIVEN | given |
| fortgeführt / weiter eingenommen (home med, now) | CONTINUED-active | given |
| geplant / vorgesehen / soll / Entlassmedikation | PLANNED | not given |
| besprochen / empfohlen / Tumorboard | DISCUSSED | not given |
| verweigert / abgelehnt / Revers | REFUSED | not given |
| Cave / kein **+ drug** / verzichtet auf / zurückgehalten | WITHHELD | not given |
| pausiert / ausgesetzt | PAUSED | not given |
| abgesetzt / ex | STOPPED | not given |
| Z. n. / dated past therapy / background list | HISTORICAL | not given |
| bei Bedarf / b. B. (no admin documented) | PLANNED (tag prn) | not given |
| frustran (attempt failed) | PLANNED (tag frustran) | not given |
| kein **+ finding** / lab / radiology / exam | **DROP** | — |