feat: derive subject status from visits

This commit is contained in:
Cheng Zhou
2026-05-21 14:47:42 +08:00
parent 9305ced664
commit da6f2f2d41
6 changed files with 125 additions and 26 deletions
+3 -2
View File
@@ -176,9 +176,10 @@ async def update_subject(
# 基线/治疗日期是访视计划的唯一推算基准,不能用入组日期替代。
if updated.baseline_date:
await subject_crud.sync_visits_from_baseline(db, updated)
updated = await subject_crud.sync_subject_status(db, updated)
detail = None
if subject_in.status and subject_in.status != old_status:
detail = f"参与者 {updated.subject_no} 状态 {old_status} -> {subject_in.status}"
if updated.status != old_status:
detail = f"参与者 {updated.subject_no} 状态 {old_status} -> {updated.status}"
await audit_crud.log_action(
db,
study_id=study_id,
+3 -1
View File
@@ -98,6 +98,7 @@ async def create_visit(
base_date=visit_in.planned_date,
visit_schedule=study.visit_schedule,
)
subject = await subject_crud.sync_subject_status(db, subject)
await audit_crud.log_action(
db,
study_id=study_id,
@@ -147,7 +148,6 @@ async def create_early_termination(
db,
subject,
SubjectUpdate(
status="DROPPED",
completion_date=termination_in.termination_date,
drop_reason=reason,
),
@@ -192,6 +192,7 @@ async def update_visit(
if visit_in.actual_date and visit.window_end and visit_in.actual_date > visit.window_end:
raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail="实际访视日期不能晚于访视窗口结束日期")
updated = await visit_crud.update_visit(db, visit, visit_in)
await subject_crud.sync_subject_status(db, subject)
detail = None
if visit_in.status:
detail = f"访视 {visit.visit_code} {visit.status} -> {visit_in.status}"
@@ -226,6 +227,7 @@ async def delete_visit(
if not visit or visit.subject_id != subject_id or visit.study_id != study_id:
raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="访视不存在")
await visit_crud.delete_visit(db, visit)
await subject_crud.sync_subject_status(db, subject)
await audit_crud.log_action(
db,
study_id=study_id,
+69 -1
View File
@@ -16,6 +16,55 @@ from app.models.subject import Subject
from app.schemas.subject import SubjectCreate, SubjectUpdate
def _visit_code(visit) -> str:
return str(getattr(visit, "visit_code", "") or "").strip()
def _is_cancelled_visit(visit) -> bool:
return str(getattr(visit, "status", "") or "").strip().upper() == "CANCELLED"
def _standard_visit_codes(visit_schedule: list[dict] | None) -> set[str]:
return {
str(item.get("visit_code") or "").strip()
for item in visit_schedule or []
if str(item.get("visit_code") or "").strip()
and str(item.get("visit_code") or "").strip() not in visit_crud.NON_TREATMENT_VISIT_CODES
}
def derive_subject_status(subject, visits: Sequence[Visit], visit_schedule: list[dict] | None = None) -> str:
if any(_visit_code(visit) == "提前终止" and getattr(visit, "actual_date", None) for visit in visits):
return "DROPPED"
standard_codes = _standard_visit_codes(visit_schedule)
completion_visits = [
visit
for visit in visits
if _visit_code(visit) not in visit_crud.NON_TREATMENT_VISIT_CODES
and not _is_cancelled_visit(visit)
and getattr(visit, "planned_date", None) is not None
]
if standard_codes:
standard_visits = [visit for visit in completion_visits if _visit_code(visit) in standard_codes]
if standard_visits:
latest_planned_date = max(getattr(visit, "planned_date") for visit in completion_visits)
latest_visits = [
visit for visit in completion_visits if getattr(visit, "planned_date", None) == latest_planned_date
]
if latest_visits and all(getattr(visit, "actual_date", None) for visit in latest_visits):
return "COMPLETED"
elif completion_visits:
latest_planned_date = max(getattr(visit, "planned_date") for visit in completion_visits)
latest_visits = [visit for visit in completion_visits if getattr(visit, "planned_date", None) == latest_planned_date]
if latest_visits and all(getattr(visit, "actual_date", None) for visit in latest_visits):
return "COMPLETED"
if getattr(subject, "enrollment_date", None):
return "ENROLLED"
return "SCREENING"
def _validate_subject_date_chain(
*,
screening_date: date | None,
@@ -80,6 +129,7 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
await db.refresh(subject)
await sync_visits_from_baseline(db, subject)
await sync_subject_status(db, subject)
return subject
@@ -121,12 +171,30 @@ async def sync_visits_from_baseline(db: AsyncSession, subject: Subject) -> None:
)
async def sync_subject_status(db: AsyncSession, subject: Subject) -> Subject:
visits_result = await db.execute(select(Visit).where(Visit.subject_id == subject.id))
visits = list(visits_result.scalars().all())
study_result = await db.execute(select(Study.visit_schedule).where(Study.id == subject.study_id))
visit_schedule = study_result.scalar_one_or_none() or []
next_status = derive_subject_status(subject, visits, visit_schedule)
if subject.status != next_status:
await db.execute(
sa_update(Subject)
.where(Subject.id == subject.id)
.values(status=next_status)
)
await db.commit()
await db.refresh(subject)
return subject
async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:
await sync_visits_from_baseline(db, subject)
async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
update_data = subject_in.model_dump(exclude_unset=True)
update_data.pop("status", None)
next_screening_date = subject.screening_date
next_consent_date = update_data.get("consent_date", subject.consent_date)
next_enrollment_date = update_data.get("enrollment_date", subject.enrollment_date)
@@ -146,7 +214,7 @@ async def update_subject(db: AsyncSession, subject: Subject, subject_in: Subject
)
await db.commit()
await db.refresh(subject)
return subject
return await sync_subject_status(db, subject)
def should_generate_visits_after_subject_update(
+49 -1
View File
@@ -1,7 +1,7 @@
from datetime import date
from types import SimpleNamespace
from app.crud.subject import should_generate_visits_after_subject_update
from app.crud.subject import derive_subject_status, should_generate_visits_after_subject_update
from app.crud.visit import (
build_early_termination_visit_changes,
build_visit_schedule_dates,
@@ -227,3 +227,51 @@ def test_validate_early_termination_date_requires_date_before_last_visit_window_
assert "提前终止日期必须早于方案最后一个计划访视窗口开始日" in str(exc)
else:
raise AssertionError("same-day final visit window start should not be accepted as early termination")
def test_derive_subject_status_marks_dropped_when_early_termination_has_actual_date():
subject = SimpleNamespace(screening_date=date(2026, 5, 1), enrollment_date=date(2026, 5, 3))
visits = [
SimpleNamespace(visit_code="V1", planned_date=date(2026, 5, 10), actual_date=date(2026, 5, 10), status="DONE", created_at=None),
SimpleNamespace(visit_code="提前终止", planned_date=None, actual_date=date(2026, 5, 12), status="DONE", created_at=None),
]
assert derive_subject_status(subject, visits, [{"visit_code": "V1"}]) == "DROPPED"
def test_derive_subject_status_marks_completed_when_last_standard_visit_has_actual_date():
subject = SimpleNamespace(screening_date=date(2026, 5, 1), enrollment_date=date(2026, 5, 3))
visits = [
SimpleNamespace(visit_code="V1", planned_date=date(2026, 5, 10), actual_date=date(2026, 5, 10), status="DONE", created_at=None),
SimpleNamespace(visit_code="V2", planned_date=date(2026, 5, 17), actual_date=date(2026, 5, 17), status="DONE", created_at=None),
]
assert derive_subject_status(subject, visits, [{"visit_code": "V1"}, {"visit_code": "V2"}]) == "COMPLETED"
def test_derive_subject_status_rolls_back_to_enrolled_when_followup_after_standard_end_is_unfinished():
subject = SimpleNamespace(screening_date=date(2026, 5, 1), enrollment_date=date(2026, 5, 3))
visits = [
SimpleNamespace(visit_code="V1", planned_date=date(2026, 5, 10), actual_date=date(2026, 5, 10), status="DONE", created_at=None),
SimpleNamespace(visit_code="V2", planned_date=date(2026, 5, 17), actual_date=date(2026, 5, 17), status="DONE", created_at=None),
SimpleNamespace(visit_code="安全性随访", planned_date=date(2026, 5, 24), actual_date=None, status="PLANNED", created_at=None),
]
assert derive_subject_status(subject, visits, [{"visit_code": "V1"}, {"visit_code": "V2"}]) == "ENROLLED"
def test_derive_subject_status_uses_completed_standard_visit_when_extra_visit_is_before_standard_end():
subject = SimpleNamespace(screening_date=date(2026, 5, 1), enrollment_date=date(2026, 5, 3))
visits = [
SimpleNamespace(visit_code="V1", planned_date=date(2026, 5, 10), actual_date=date(2026, 5, 10), status="DONE", created_at=None),
SimpleNamespace(visit_code="安全性随访", planned_date=date(2026, 5, 12), actual_date=None, status="PLANNED", created_at=None),
SimpleNamespace(visit_code="V2", planned_date=date(2026, 5, 17), actual_date=date(2026, 5, 17), status="DONE", created_at=None),
]
assert derive_subject_status(subject, visits, [{"visit_code": "V1"}, {"visit_code": "V2"}]) == "COMPLETED"
def test_derive_subject_status_marks_screening_until_enrollment_date_is_filled():
subject = SimpleNamespace(screening_date=date(2026, 5, 1), enrollment_date=None)
assert derive_subject_status(subject, [], []) == "SCREENING"