@damourlabs/euro-clinical-trials

// Drizzle ORM schema for Patient Management tables import { pgTable, uuid, varchar, text, timestamp, integer, decimal, date, check, index, pgEnum } from 'drizzle-orm/pg-core'; import { sql } from 'drizzle-orm'; import { trials, sites } from '.'; import { ConsentStatusEnum, PatientStatusEnum } from './enums'; import { z } from 'zod'; import type { Expect, IsSameType } from '~/types/equality'; const patiensFieldDefaultValues = { subjectId: 'Unknown', status: PatientStatusEnum.Enum.Active, consentStatus: ConsentStatusEnum.Enum.NotConsented, dataCompleteness: '0.00', enrollmentDate: () => new Date().toISOString().split('T')[0], // randomizationGroup: 'NotAssigned', createdAt: () => new Date(), updatedAt: () => new Date(), }; export const pgPatientStatusEnum = pgEnum('patient_status_enum', PatientStatusEnum.options); export const pgConsentStatusEnum = pgEnum('consent_status_enum', ConsentStatusEnum.options); export const patients = pgTable('patients', { uuid: uuid('uuid').primaryKey().defaultRandom(), trialUuid: uuid('trial_uuid').notNull().references(() => trials.uuid, { onDelete: 'cascade' }), siteUuid: uuid('site_uuid').notNull().references(() => sites.uuid, { onDelete: 'cascade' }), subjectId: varchar('subject_id', { length: 50 }).notNull(), status: pgPatientStatusEnum("status").notNull().default(patiensFieldDefaultValues.status), consentStatus: pgConsentStatusEnum("consent_status").notNull().default(patiensFieldDefaultValues.consentStatus), dataCompleteness: decimal('data_completeness', { precision: 5, scale: 2 }).notNull().default(patiensFieldDefaultValues.dataCompleteness), enrollmentDate: date('enrollment_date').default(sql`CURRENT_DATE`), randomizationGroup: varchar('randomization_group', { length: 50 }).notNull().default(patiensFieldDefaultValues.randomizationGroup), withdrawalDate: date('withdrawal_date'), createdAt: timestamp('created_at', { withTimezone: true }).notNull().defaultNow(), updatedAt: timestamp('updated_at', { withTimezone: true }).notNull().defaultNow(), }, (table) => [ index('idx_patients_trial').on(table.trialUuid), index('idx_patients_site').on(table.siteUuid), index('idx_patients_status').on(table.status), index('idx_patients_trial_status').on(table.trialUuid, table.status), check('patients_data_completeness_range', sql`${table.dataCompleteness} >= 0.00 AND ${table.dataCompleteness} <= 100.00`), check('patients_enrollment_before_withdrawal', sql`${table.enrollmentDate} IS NULL OR ${table.withdrawalDate} IS NULL OR ${table.enrollmentDate} <= ${table.withdrawalDate}`), ]); export const patientSchema = z.object({ uuid: z.string() .uuid() .min(1, "Patient UUID is required") .describe("Unique identifier for the patient, automatically generated if not provided") , trialUuid: z.string() .uuid() .min(1, "Trial UUID is required") .describe("UUID of the trial this patient is enrolled in") , siteUuid: z.string() .uuid() .min(1, "Site UUID is required") .describe("UUID of the site where the patient is enrolled") , subjectId: z.string() .max(50, "Subject ID must be less than 50 characters") .default(patiensFieldDefaultValues.subjectId) .describe("Unique identifier for the patient within the trial") , status: PatientStatusEnum .default(patiensFieldDefaultValues.status) .describe("Current status of the patient in the trial") , consentStatus: ConsentStatusEnum .default(patiensFieldDefaultValues.consentStatus) .describe("Consent status of the patient for data processing and participation in the trial") , dataCompleteness: z.string() .regex(/^\d{1,3}(\.\d{1,2})?$/, "Data completeness must be a valid decimal between 0.00 and 100.00") .default(patiensFieldDefaultValues.dataCompleteness) .describe("Percentage of data completeness for the patient") , enrollmentDate: z.string() .date() .nullable() .default(patiensFieldDefaultValues.enrollmentDate) .describe("Date when the patient was enrolled in the trial, defaults to today if not provided") , randomizationGroup: z.string() .max(50, "Randomization group must be less than 50 characters") .default(patiensFieldDefaultValues.randomizationGroup) .describe("Randomization group the patient belongs to, if applicable") , withdrawalDate: z.string() .date() .nullable() .describe("Date when the patient withdrew from the trial, if applicable") , createdAt: z.date() .describe("Timestamp when the patient record was created, defaults to now") , updatedAt: z.date() .describe("Timestamp when the patient record was last updated, defaults to now") , }) // --- Visits Schema --- const visitsFieldDefaultValues = { visitType: 'Screening', status: 'Scheduled', }; export const visits = pgTable('visits', { uuid: uuid('uuid').primaryKey().defaultRandom(), patientUuid: uuid('patient_uuid').notNull().references(() => patients.uuid, { onDelete: 'cascade' }), siteUuid: uuid('site_uuid').notNull().references(() => sites.uuid, { onDelete: 'cascade' }), visitDate: date('visit_date').notNull().default(sql`CURRENT_DATE`), visitType: varchar('visit_type', { length: 15 }).notNull().default(visitsFieldDefaultValues.visitType), status: varchar('status', { length: 15 }).notNull().default(visitsFieldDefaultValues.status), notes: text('notes'), createdAt: timestamp('created_at', { withTimezone: true }).notNull().defaultNow(), updatedAt: timestamp('updated_at', { withTimezone: true }).notNull().defaultNow(), }, (table) => [ index('idx_visits_patient').on(table.patientUuid), index('idx_visits_date').on(table.visitDate), index('idx_visits_patient_date').on(table.patientUuid, table.visitDate), ]); export const VisitSchema = z.object({ uuid: z.string() .uuid() .describe("Unique identifier for the visit, automatically generated if not provided") .default(() => crypto.randomUUID()) , patientUuid: z.string() .uuid() .describe("UUID of the patient associated with this visit") , siteUuid: z.string() .uuid() .describe("UUID of the site where the visit is conducted") , visitDate: z.string() .date() .default(() => new Date().toISOString().split('T')[0]) .describe("Date of the visit, defaults to today if not provided") , visitType: z.string() .min(1, "Visit type must be at least 1 character long") .max(15, "Visit type must be less than 15 characters") .default('Screening') .describe("Type of the visit (e.g., Screening, FollowUp, EndOfTrial)") , status: z.string() .max(15, "Status must be less than 15 characters") .default('Scheduled') .describe("Current status of the visit (e.g., Scheduled, Completed, Cancelled, NoShow)") , notes: z.string() .max(500, "Notes must be less than 500 characters") .nullable() .describe("Additional notes for the visit") , createdAt: z.date() .describe("Timestamp when the visit record was created") , updatedAt: z.date() .describe("Timestamp when the visit record was last updated") }); // --- Vital Signs Schema --- export const vitalSigns = pgTable('vital_signs', { uuid: uuid('uuid').primaryKey().defaultRandom(), patientUuid: uuid('patient_uuid').notNull().references(() => patients.uuid, { onDelete: 'cascade' }), visitUuid: uuid('visit_uuid').notNull().references(() => visits.uuid, { onDelete: 'cascade' }), heartRate: integer('heart_rate'), systolicBp: integer('systolic_bp'), diastolicBp: integer('diastolic_bp'), temperature: decimal('temperature', { precision: 4, scale: 2 }), respiratoryRate: integer('respiratory_rate'), oxygenSaturation: decimal('oxygen_saturation', { precision: 5, scale: 2 }), recordedAt: timestamp('recorded_at', { withTimezone: true }).notNull().defaultNow(), createdAt: timestamp('created_at', { withTimezone: true }).notNull().defaultNow(), updatedAt: timestamp('updated_at', { withTimezone: true }).notNull().defaultNow(), }, (table) => [ check('vital_signs_heart_rate_range', sql`${table.heartRate} IS NULL OR (${table.heartRate} >= 0 AND ${table.heartRate} <= 300)`), check('vital_signs_systolic_bp_range', sql`${table.systolicBp} IS NULL OR (${table.systolicBp} >= 0 AND ${table.systolicBp} <= 370)`), check('vital_signs_diastolic_bp_range', sql`${table.diastolicBp} IS NULL OR (${table.diastolicBp} >= 0 AND ${table.diastolicBp} <= 360)`), check('vital_signs_temperature_range', sql`${table.temperature} IS NULL OR (${table.temperature} >= 30.00 AND ${table.temperature} <= 45.00)`), check('vital_signs_respiratory_rate_range', sql`${table.respiratoryRate} IS NULL OR (${table.respiratoryRate} >= 0 AND ${table.respiratoryRate} <= 100)`), check('vital_signs_oxygen_saturation_range', sql`${table.oxygenSaturation} IS NULL OR (${table.oxygenSaturation} >= 0.00 AND ${table.oxygenSaturation} <= 100.00)`), check('vital_signs_bp_relationship', sql`${table.systolicBp} IS NULL OR ${table.diastolicBp} IS NULL OR ${table.systolicBp} >= ${table.diastolicBp}`), ]); export const VitalSignsSchema = z.object({ uuid: z.string() .uuid() .describe("Unique identifier for the vital signs record, automatically generated if not provided") .default(() => crypto.randomUUID()) , patientUuid: z.string() .uuid() .describe("UUID of the patient associated with these vital signs") , visitUuid: z.string() .uuid() .describe("UUID of the visit during which these vital signs were recorded") , heartRate: z.number() .min(0, "Heart rate must be a non-negative integer") .max(300, "Heart rate must be less than or equal to 300") .nullable() .describe("Heart rate in beats per minute") , systolicBp: z.number() .min(0, "Systolic blood pressure must be a non-negative integer") .max(370, "Systolic blood pressure must be less than or equal to 370") .nullable() .describe("Systolic blood pressure in mmHg") , diastolicBp: z.number() .min(0, "Diastolic blood pressure must be a non-negative integer") .max(360, "Diastolic blood pressure must be less than or equal to 360") .nullable() .describe("Diastolic blood pressure in mmHg") , // Since we use decimal for temperature, we check for string instead of number temperature: z.string() .regex(/^\d{1,2}(\.\d{1,2})?$/, "Temperature must be a valid decimal number") .nullable() .describe("Body temperature in degrees Celsius, formatted as a decimal") , respiratoryRate: z.number() .min(0, "Respiratory rate must be a non-negative integer") .max(100, "Respiratory rate must be less than or equal to 100 breaths per minute") .nullable() .describe("Respiratory rate in breaths per minute") , // Same as temperature oxygenSaturation: z.string() .regex(/^\d{1,3}(\.\d{1,2})?$/, "Oxygen saturation must be a valid decimal number") .nullable() .describe("Oxygen saturation percentage, formatted as a decimal") , recordedAt: z.date() .describe("Timestamp when the vital signs were recorded, defaults to now") , createdAt: z.date() .describe("Timestamp when the vital signs record was created") , updatedAt: z.date() .describe("Timestamp when the vital signs record was last updated") , }); // --- Patient Statistics --- export const PatientStatisticsSchema = z.object({ totalPatients: z.number().int().min(0).describe("Total number of patients enrolled in the trial"), activePatients: z.number().int().min(0).describe("Number of patients currently active in the trial"), completedPatients: z.number().int().min(0).describe("Number of patients who have completed the trial"), withdrawnPatients: z.number().int().min(0).describe("Number of patients who have withdrawn from the trial"), patientsByStatus: z.record(PatientStatusEnum, z.number().int().min(0)).describe("Count of patients grouped by their current status in the trial"), }); export type Patient = z.infer<typeof patientSchema>; export type Visit = z.infer<typeof VisitSchema>; export type VitalSigns = z.infer<typeof VitalSignsSchema>; export type PatientStatistics = z.infer<typeof PatientStatisticsSchema>; // Validate to check if the schema respects the table structure // If this fails, it means the schema and table structure are not in sync // i.e: // - the schema has fields that are not present in the table or vice versa // - the types of the fields do not match type _patienSchemaMatchesTable = Expect<IsSameType<Patient, typeof patients.$inferSelect>>; type _visitSchemaMatchesTable = Expect<IsSameType<Visit, typeof visits.$inferSelect>>; type _vitalSignsSchemaMatchesTable = Expect<IsSameType<VitalSigns, typeof vitalSigns.$inferSelect>>;