Cheng Zhou
121 lines
4.2 KiB
Python
121 lines
4.2 KiB
Python
import uuid
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from datetime import date, timedelta
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from typing import Sequence
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from sqlalchemy import select, update as sa_update
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.models.ae import AdverseEvent
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from app.models.site import Site
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from app.models.subject import Subject
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from app.schemas.ae import AECreate, AEUpdate
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def _calc_due_date(onset: date | None, seriousness: str) -> date | None:
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if onset is None:
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return None
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delta = 1 if seriousness == "SERIOUS" else 7
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return onset + timedelta(days=delta)
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async def _validate_site_subject(db: AsyncSession, study_id: uuid.UUID, site_id: uuid.UUID | None, subject_id: uuid.UUID | None):
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if site_id:
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result = await db.execute(select(Site).where(Site.id == site_id))
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site = result.scalar_one_or_none()
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if not site or site.study_id != study_id:
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raise ValueError("分中心不属于当前项目")
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if subject_id:
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result = await db.execute(select(Subject).where(Subject.id == subject_id))
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subj = result.scalar_one_or_none()
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if not subj or subj.study_id != study_id:
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raise ValueError("参与者不属于当前项目")
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async def create_ae(
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db: AsyncSession,
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study_id: uuid.UUID,
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ae_in: AECreate,
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*,
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created_by: uuid.UUID,
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) -> AdverseEvent:
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await _validate_site_subject(db, study_id, ae_in.site_id, ae_in.subject_id)
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due_date = _calc_due_date(ae_in.onset_date, ae_in.seriousness)
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ae = AdverseEvent(
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study_id=study_id,
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site_id=ae_in.site_id,
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subject_id=ae_in.subject_id,
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visit_id=ae_in.visit_id,
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term=ae_in.term,
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onset_date=ae_in.onset_date,
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resolution_date=None,
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seriousness=ae_in.seriousness,
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severity=ae_in.severity,
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causality=ae_in.causality,
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action_taken=None,
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outcome=ae_in.outcome,
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reported_to_sponsor=False,
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report_due_date=due_date,
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status="NEW",
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description=ae_in.description,
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created_by=created_by,
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)
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db.add(ae)
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await db.commit()
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await db.refresh(ae)
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return ae
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async def get_ae(db: AsyncSession, ae_id: uuid.UUID) -> AdverseEvent | None:
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result = await db.execute(select(AdverseEvent).where(AdverseEvent.id == ae_id))
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return result.scalar_one_or_none()
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async def list_ae(
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db: AsyncSession,
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study_id: uuid.UUID,
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status: str | None = None,
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seriousness: str | None = None,
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site_id: uuid.UUID | None = None,
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subject_id: uuid.UUID | None = None,
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overdue: bool | None = None,
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) -> Sequence[AdverseEvent]:
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stmt = select(AdverseEvent).where(AdverseEvent.study_id == study_id)
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if status:
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stmt = stmt.where(AdverseEvent.status == status)
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if seriousness:
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stmt = stmt.where(AdverseEvent.seriousness == seriousness)
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if site_id:
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stmt = stmt.where(AdverseEvent.site_id == site_id)
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if subject_id:
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stmt = stmt.where(AdverseEvent.subject_id == subject_id)
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if overdue is True:
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stmt = stmt.where(AdverseEvent.report_due_date < date.today(), AdverseEvent.status != "CLOSED")
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if overdue is False:
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stmt = stmt.where((AdverseEvent.report_due_date >= date.today()) | (AdverseEvent.report_due_date.is_(None)) | (AdverseEvent.status == "CLOSED"))
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result = await db.execute(stmt)
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return result.scalars().all()
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async def update_ae(db: AsyncSession, study_id: uuid.UUID, ae: AdverseEvent, ae_in: AEUpdate) -> AdverseEvent:
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update_data = ae_in.model_dump(exclude_unset=True)
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if "subject_id" in update_data:
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await _validate_site_subject(db, study_id, None, update_data["subject_id"])
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if "onset_date" in update_data or "seriousness" in update_data:
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onset = update_data.get("onset_date", ae.onset_date)
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seriousness = update_data.get("seriousness", ae.seriousness)
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update_data["report_due_date"] = _calc_due_date(onset, seriousness)
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if update_data:
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await db.execute(
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sa_update(AdverseEvent)
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.where(AdverseEvent.id == ae.id)
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.values(**update_data)
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)
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await db.commit()
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await db.refresh(ae)
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return ae
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async def delete_ae(db: AsyncSession, ae: AdverseEvent) -> None:
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await db.delete(ae)
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await db.commit()
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