@erosolaraijs/cure 1.0.0 → 1.0.2

package/dist/validation/retrospectiveValidator.js

@@ -0,0 +1,602 @@
+/**
+ * Retrospective Validation Framework
+ *
+ * Provides tools for validating the treatment recommendation system against
+ * real patient outcomes. Essential for:
+ * - Model performance assessment
+ * - Calibration checking
+ * - Concordance analysis with actual treatments
+ * - Outcome correlation studies
+ * - Continuous quality improvement
+ *
+ * IMPORTANT: All patient data used for validation must be properly de-identified
+ * or used with appropriate IRB approval and patient consent.
+ */
+import { EventEmitter } from 'events';
+import { createHash } from 'crypto';
+// ═══════════════════════════════════════════════════════════════════════════════
+// VALIDATION SERVICE
+// ═══════════════════════════════════════════════════════════════════════════════
+export class RetrospectiveValidationService extends EventEmitter {
+    validationCohorts = new Map();
+    systemRecommendations = new Map();
+    validationResults = new Map();
+    constructor() {
+        super();
+    }
+    /**
+     * Load a validation cohort
+     */
+    loadCohort(cohortId, patients) {
+        // De-identify and validate data
+        const validatedPatients = patients.map(p => this.validateAndDeidentify(p));
+        this.validationCohorts.set(cohortId, validatedPatients);
+        this.emit('cohort-loaded', { cohortId, patientCount: validatedPatients.length });
+    }
+    /**
+     * Load system recommendations for comparison
+     */
+    loadRecommendations(recommendations) {
+        for (const rec of recommendations) {
+            this.systemRecommendations.set(rec.patientId, rec);
+        }
+        this.emit('recommendations-loaded', { count: recommendations.length });
+    }
+    /**
+     * Run validation for a cohort
+     */
+    async runValidation(cohortId) {
+        const patients = this.validationCohorts.get(cohortId);
+        if (!patients) {
+            throw new Error(`Cohort ${cohortId} not found`);
+        }
+        const results = [];
+        // Validate each patient
+        for (const patient of patients) {
+            const recommendation = this.systemRecommendations.get(patient.id);
+            const result = this.validatePatient(patient, recommendation);
+            results.push(result);
+            this.validationResults.set(patient.id, result);
+        }
+        // Compute cohort-level metrics
+        const analysis = this.computeCohortAnalysis(cohortId, patients, results);
+        this.emit('validation-complete', { cohortId, analysis });
+        return analysis;
+    }
+    /**
+     * Validate a single patient
+     */
+    validatePatient(patient, recommendation) {
+        // Concordance analysis
+        const concordance = this.assessConcordance(patient, recommendation);
+        // Calculate actual outcomes
+        const actualPFS = this.calculatePFS(patient);
+        const actualOS = this.calculateOS(patient);
+        const actualGrade3Plus = (patient.outcomes.toxicities || []).some(t => t.grade >= 3);
+        // Compare predictions to outcomes
+        const outcomeComparison = {
+            predictedResponse: recommendation?.predictions.responseRate || 0,
+            actualResponse: patient.outcomes.bestResponse,
+            responseCorrect: this.assessResponseAccuracy(recommendation?.predictions.responseRate || 0, patient.outcomes.bestResponse),
+            predictedPFS: recommendation?.predictions.pfsMonths || 0,
+            actualPFS,
+            pfsDifference: actualPFS !== undefined ? actualPFS - (recommendation?.predictions.pfsMonths || 0) : undefined,
+            predictedOS: recommendation?.predictions.osMonths || 0,
+            actualOS,
+            osDifference: actualOS !== undefined ? actualOS - (recommendation?.predictions.osMonths || 0) : undefined,
+            predictedToxicityRisk: recommendation?.predictions.toxicityRisk || 0,
+            actualGrade3PlusToxicity: actualGrade3Plus
+        };
+        // Clinical benefit assessment
+        const clinicalBenefit = {
+            objectiveResponse: ['CR', 'PR'].includes(patient.outcomes.bestResponse || ''),
+            diseaseControl: ['CR', 'PR', 'SD'].includes(patient.outcomes.bestResponse || ''),
+            durableBenefit: actualPFS !== undefined && actualPFS >= 6
+        };
+        return {
+            patientId: patient.id,
+            concordance,
+            outcomeComparison,
+            clinicalBenefit
+        };
+    }
+    /**
+     * Assess concordance between recommendation and actual treatment
+     */
+    assessConcordance(patient, recommendation) {
+        if (!recommendation) {
+            return {
+                regimenMatch: false,
+                partialMatch: false,
+                matchedDrugs: []
+            };
+        }
+        const actualDrugs = patient.treatment.drugs.map(d => d.toLowerCase());
+        const recommendedDrugs = recommendation.recommendedDrugs.map(d => d.toLowerCase());
+        const matchedDrugs = recommendedDrugs.filter(rd => actualDrugs.some(ad => this.drugsMatch(ad, rd)));
+        const regimenMatch = matchedDrugs.length === recommendedDrugs.length &&
+            matchedDrugs.length === actualDrugs.length;
+        const partialMatch = matchedDrugs.length > 0;
+        return {
+            regimenMatch,
+            partialMatch,
+            matchedDrugs
+        };
+    }
+    /**
+     * Check if two drug names refer to the same drug
+     */
+    drugsMatch(drug1, drug2) {
+        // Normalize names
+        const normalize = (s) => s.toLowerCase().replace(/[^a-z0-9]/g, '');
+        if (normalize(drug1) === normalize(drug2))
+            return true;
+        // Check brand/generic equivalents
+        const equivalents = {
+            'pembrolizumab': ['keytruda'],
+            'nivolumab': ['opdivo'],
+            'osimertinib': ['tagrisso'],
+            'alectinib': ['alecensa'],
+            'trastuzumab': ['herceptin'],
+            'pertuzumab': ['perjeta'],
+            'olaparib': ['lynparza'],
+            'palbociclib': ['ibrance'],
+            'carboplatin': ['paraplatin'],
+            'paclitaxel': ['taxol'],
+            'docetaxel': ['taxotere']
+        };
+        for (const [generic, brands] of Object.entries(equivalents)) {
+            const allNames = [generic, ...brands].map(normalize);
+            if (allNames.includes(normalize(drug1)) && allNames.includes(normalize(drug2))) {
+                return true;
+            }
+        }
+        return false;
+    }
+    /**
+     * Calculate PFS in months
+     */
+    calculatePFS(patient) {
+        const startDate = patient.treatment.startDate;
+        let endDate;
+        if (patient.outcomes.progressionDate) {
+            endDate = patient.outcomes.progressionDate;
+        }
+        else if (patient.outcomes.deathDate) {
+            endDate = patient.outcomes.deathDate;
+        }
+        else {
+            // Censored at last follow-up
+            endDate = patient.outcomes.lastFollowUpDate;
+        }
+        const months = (endDate.getTime() - startDate.getTime()) / (1000 * 60 * 60 * 24 * 30.44);
+        return Math.round(months * 10) / 10;
+    }
+    /**
+     * Calculate OS in months
+     */
+    calculateOS(patient) {
+        const startDate = patient.diagnosis.diagnosisDate;
+        let endDate;
+        if (patient.outcomes.deathDate) {
+            endDate = patient.outcomes.deathDate;
+        }
+        else {
+            // Censored at last follow-up
+            endDate = patient.outcomes.lastFollowUpDate;
+        }
+        const months = (endDate.getTime() - startDate.getTime()) / (1000 * 60 * 60 * 24 * 30.44);
+        return Math.round(months * 10) / 10;
+    }
+    /**
+     * Assess if response prediction was accurate
+     */
+    assessResponseAccuracy(predictedRate, actualResponse) {
+        if (!actualResponse || actualResponse === 'NE')
+            return undefined;
+        const predicted = predictedRate >= 0.5 ? 'responder' : 'non-responder';
+        const actual = ['CR', 'PR'].includes(actualResponse) ? 'responder' : 'non-responder';
+        return predicted === actual;
+    }
+    /**
+     * Compute cohort-level analysis
+     */
+    computeCohortAnalysis(cohortId, patients, results) {
+        // Demographics
+        const ages = patients.map(p => p.demographics.ageAtDiagnosis);
+        const maleCount = patients.filter(p => p.demographics.gender === 'male').length;
+        const stageDistribution = {};
+        for (const p of patients) {
+            stageDistribution[p.diagnosis.stage] = (stageDistribution[p.diagnosis.stage] || 0) + 1;
+        }
+        // Concordance metrics
+        const fullConcordance = results.filter(r => r.concordance.regimenMatch).length / results.length;
+        const partialConcordance = results.filter(r => r.concordance.partialMatch && !r.concordance.regimenMatch).length / results.length;
+        // Response accuracy
+        const responseResults = results.filter(r => r.outcomeComparison.responseCorrect !== undefined);
+        const responseAccuracy = responseResults.length > 0
+            ? responseResults.filter(r => r.outcomeComparison.responseCorrect).length / responseResults.length
+            : 0;
+        // Sensitivity (correctly predicted responders)
+        const actualResponders = results.filter(r => ['CR', 'PR'].includes(r.outcomeComparison.actualResponse || ''));
+        const responseSensitivity = actualResponders.length > 0
+            ? actualResponders.filter(r => r.outcomeComparison.predictedResponse >= 0.5).length / actualResponders.length
+            : 0;
+        // Specificity (correctly predicted non-responders)
+        const actualNonResponders = results.filter(r => ['SD', 'PD'].includes(r.outcomeComparison.actualResponse || ''));
+        const responseSpecificity = actualNonResponders.length > 0
+            ? actualNonResponders.filter(r => r.outcomeComparison.predictedResponse < 0.5).length / actualNonResponders.length
+            : 0;
+        // PFS concordance index (simplified)
+        const pfsCIndex = this.calculateCIndex(results.map(r => r.outcomeComparison.predictedPFS), results.map(r => r.outcomeComparison.actualPFS || 0));
+        // PFS calibration
+        const pfsCalibration = this.calculateCalibration(results.map(r => r.outcomeComparison.predictedPFS), results.map(r => r.outcomeComparison.actualPFS || 0));
+        // OS metrics (similar calculation)
+        const osCIndex = this.calculateCIndex(results.map(r => r.outcomeComparison.predictedOS), results.map(r => r.outcomeComparison.actualOS || 0));
+        const osCalibration = this.calculateCalibration(results.map(r => r.outcomeComparison.predictedOS), results.map(r => r.outcomeComparison.actualOS || 0));
+        // Toxicity accuracy
+        const toxicityResults = results.filter(r => r.outcomeComparison.predictedToxicityRisk > 0);
+        const toxicityAccuracy = toxicityResults.length > 0
+            ? toxicityResults.filter(r => {
+                const predicted = r.outcomeComparison.predictedToxicityRisk >= 0.3;
+                return predicted === r.outcomeComparison.actualGrade3PlusToxicity;
+            }).length / toxicityResults.length
+            : 0;
+        // Clinical outcomes
+        const objectiveResponseRate = results.filter(r => r.clinicalBenefit.objectiveResponse).length / results.length;
+        const diseaseControlRate = results.filter(r => r.clinicalBenefit.diseaseControl).length / results.length;
+        const pfsValues = results.map(r => r.outcomeComparison.actualPFS).filter(v => v !== undefined);
+        const medianPFS = this.calculateMedian(pfsValues);
+        const osValues = results.map(r => r.outcomeComparison.actualOS).filter(v => v !== undefined);
+        const medianOS = this.calculateMedian(osValues);
+        // Concordant vs discordant outcomes
+        const concordantResults = results.filter(r => r.concordance.regimenMatch || r.concordance.partialMatch);
+        const discordantResults = results.filter(r => !r.concordance.regimenMatch && !r.concordance.partialMatch);
+        const concordantORR = concordantResults.length > 0
+            ? concordantResults.filter(r => r.clinicalBenefit.objectiveResponse).length / concordantResults.length
+            : 0;
+        const discordantORR = discordantResults.length > 0
+            ? discordantResults.filter(r => r.clinicalBenefit.objectiveResponse).length / discordantResults.length
+            : 0;
+        const concordantPFS = this.calculateMedian(concordantResults.map(r => r.outcomeComparison.actualPFS).filter(v => v !== undefined));
+        const discordantPFS = this.calculateMedian(discordantResults.map(r => r.outcomeComparison.actualPFS).filter(v => v !== undefined));
+        // Subgroup analyses
+        const subgroupAnalyses = this.performSubgroupAnalyses(patients, results);
+        return {
+            cohortId,
+            description: `Validation cohort with ${patients.length} patients`,
+            patientCount: patients.length,
+            dateRange: {
+                start: new Date(Math.min(...patients.map(p => p.diagnosis.diagnosisDate.getTime()))),
+                end: new Date(Math.max(...patients.map(p => p.outcomes.lastFollowUpDate.getTime())))
+            },
+            demographics: {
+                medianAge: this.calculateMedian(ages),
+                ageRange: [Math.min(...ages), Math.max(...ages)],
+                genderDistribution: {
+                    male: maleCount / patients.length,
+                    female: (patients.length - maleCount) / patients.length
+                },
+                stageDistribution
+            },
+            concordance: {
+                fullConcordance,
+                partialConcordance,
+                noConcordance: 1 - fullConcordance - partialConcordance,
+                concordanceByBiomarker: this.calculateConcordanceByBiomarker(patients, results)
+            },
+            predictionAccuracy: {
+                responseAccuracy,
+                responseSensitivity,
+                responseSpecificity,
+                pfsCIndex,
+                pfsCalibration,
+                osCIndex,
+                osCalibration,
+                toxicityAccuracy
+            },
+            clinicalImpact: {
+                objectiveResponseRate,
+                diseaseControlRate,
+                medianPFS,
+                medianOS,
+                concordantVsDiscordant: {
+                    concordantORR,
+                    discordantORR,
+                    concordantMedianPFS: concordantPFS,
+                    discordantMedianPFS: discordantPFS
+                }
+            },
+            subgroupAnalyses
+        };
+    }
+    /**
+     * Calculate concordance index (C-index)
+     */
+    calculateCIndex(predicted, actual) {
+        let concordant = 0;
+        let discordant = 0;
+        let tied = 0;
+        for (let i = 0; i < predicted.length; i++) {
+            for (let j = i + 1; j < predicted.length; j++) {
+                if (actual[i] !== actual[j]) {
+                    if ((predicted[i] > predicted[j] && actual[i] > actual[j]) ||
+                        (predicted[i] < predicted[j] && actual[i] < actual[j])) {
+                        concordant++;
+                    }
+                    else if (predicted[i] !== predicted[j]) {
+                        discordant++;
+                    }
+                    else {
+                        tied++;
+                    }
+                }
+            }
+        }
+        const total = concordant + discordant + tied;
+        return total > 0 ? (concordant + 0.5 * tied) / total : 0.5;
+    }
+    /**
+     * Calculate calibration score (0-1, higher is better)
+     */
+    calculateCalibration(predicted, actual) {
+        if (predicted.length === 0)
+            return 0;
+        // Group predictions into deciles and compare to actual
+        const combined = predicted.map((p, i) => ({ predicted: p, actual: actual[i] }))
+            .filter(c => c.actual > 0)
+            .sort((a, b) => a.predicted - b.predicted);
+        if (combined.length < 10) {
+            // Simple correlation for small samples
+            const meanPred = combined.reduce((s, c) => s + c.predicted, 0) / combined.length;
+            const meanActual = combined.reduce((s, c) => s + c.actual, 0) / combined.length;
+            const errors = combined.map(c => Math.abs(c.predicted - c.actual) / Math.max(c.actual, 1));
+            const meanError = errors.reduce((s, e) => s + e, 0) / errors.length;
+            return Math.max(0, 1 - meanError);
+        }
+        // For larger samples, use decile calibration
+        const decileSize = Math.ceil(combined.length / 10);
+        let totalError = 0;
+        for (let i = 0; i < 10; i++) {
+            const start = i * decileSize;
+            const end = Math.min((i + 1) * decileSize, combined.length);
+            const decile = combined.slice(start, end);
+            const avgPredicted = decile.reduce((s, c) => s + c.predicted, 0) / decile.length;
+            const avgActual = decile.reduce((s, c) => s + c.actual, 0) / decile.length;
+            const relativeError = avgActual > 0 ? Math.abs(avgPredicted - avgActual) / avgActual : 0;
+            totalError += relativeError;
+        }
+        return Math.max(0, 1 - totalError / 10);
+    }
+    /**
+     * Calculate median of an array
+     */
+    calculateMedian(values) {
+        if (values.length === 0)
+            return 0;
+        const sorted = [...values].sort((a, b) => a - b);
+        const mid = Math.floor(sorted.length / 2);
+        return sorted.length % 2 ? sorted[mid] : (sorted[mid - 1] + sorted[mid]) / 2;
+    }
+    /**
+     * Calculate concordance by biomarker subgroup
+     */
+    calculateConcordanceByBiomarker(patients, results) {
+        const biomarkerGroups = {};
+        for (let i = 0; i < patients.length; i++) {
+            const patient = patients[i];
+            const result = results[i];
+            // Check various biomarker categories
+            const biomarkers = [];
+            if (patient.diagnosis.msiStatus === 'MSI-H')
+                biomarkers.push('MSI-H');
+            if (patient.diagnosis.tmbValue && patient.diagnosis.tmbValue >= 10)
+                biomarkers.push('TMB-H');
+            if (patient.diagnosis.pdl1Score && patient.diagnosis.pdl1Score >= 50)
+                biomarkers.push('PD-L1≥50%');
+            if (patient.diagnosis.hrdStatus)
+                biomarkers.push('HRD+');
+            // Check genomic alterations
+            for (const alt of patient.diagnosis.genomicAlterations || []) {
+                biomarkers.push(`${alt.gene} ${alt.alteration}`);
+            }
+            // Record concordance for each biomarker
+            for (const biomarker of biomarkers) {
+                if (!biomarkerGroups[biomarker]) {
+                    biomarkerGroups[biomarker] = { concordant: 0, total: 0 };
+                }
+                biomarkerGroups[biomarker].total++;
+                if (result.concordance.regimenMatch || result.concordance.partialMatch) {
+                    biomarkerGroups[biomarker].concordant++;
+                }
+            }
+        }
+        // Convert to concordance rates
+        const concordanceByBiomarker = {};
+        for (const [biomarker, data] of Object.entries(biomarkerGroups)) {
+            if (data.total >= 5) { // Only include groups with meaningful sample size
+                concordanceByBiomarker[biomarker] = data.concordant / data.total;
+            }
+        }
+        return concordanceByBiomarker;
+    }
+    /**
+     * Perform subgroup analyses
+     */
+    performSubgroupAnalyses(patients, results) {
+        const subgroups = [];
+        // By cancer type
+        const cancerTypes = [...new Set(patients.map(p => p.diagnosis.cancerType))];
+        for (const cancerType of cancerTypes) {
+            const indices = patients.map((p, i) => p.diagnosis.cancerType === cancerType ? i : -1).filter(i => i >= 0);
+            if (indices.length >= 10) {
+                const subgroupResults = indices.map(i => results[i]);
+                const subgroupPatients = indices.map(i => patients[i]);
+                subgroups.push({
+                    subgroup: cancerType,
+                    patientCount: indices.length,
+                    concordance: subgroupResults.filter(r => r.concordance.regimenMatch || r.concordance.partialMatch).length / indices.length,
+                    responseAccuracy: this.calculateSubgroupResponseAccuracy(subgroupResults),
+                    medianPFS: this.calculateMedian(subgroupResults.map(r => r.outcomeComparison.actualPFS).filter(v => v !== undefined))
+                });
+            }
+        }
+        // By stage
+        const stages = ['I', 'II', 'III', 'IV'];
+        for (const stageGroup of stages) {
+            const indices = patients.map((p, i) => p.diagnosis.stage.startsWith(stageGroup) ? i : -1).filter(i => i >= 0);
+            if (indices.length >= 10) {
+                const subgroupResults = indices.map(i => results[i]);
+                subgroups.push({
+                    subgroup: `Stage ${stageGroup}`,
+                    patientCount: indices.length,
+                    concordance: subgroupResults.filter(r => r.concordance.regimenMatch || r.concordance.partialMatch).length / indices.length,
+                    responseAccuracy: this.calculateSubgroupResponseAccuracy(subgroupResults),
+                    medianPFS: this.calculateMedian(subgroupResults.map(r => r.outcomeComparison.actualPFS).filter(v => v !== undefined))
+                });
+            }
+        }
+        // By age group
+        const ageGroups = [
+            { name: 'Age <50', filter: (p) => p.demographics.ageAtDiagnosis < 50 },
+            { name: 'Age 50-65', filter: (p) => p.demographics.ageAtDiagnosis >= 50 && p.demographics.ageAtDiagnosis < 65 },
+            { name: 'Age 65-75', filter: (p) => p.demographics.ageAtDiagnosis >= 65 && p.demographics.ageAtDiagnosis < 75 },
+            { name: 'Age ≥75', filter: (p) => p.demographics.ageAtDiagnosis >= 75 }
+        ];
+        for (const ageGroup of ageGroups) {
+            const indices = patients.map((p, i) => ageGroup.filter(p) ? i : -1).filter(i => i >= 0);
+            if (indices.length >= 10) {
+                const subgroupResults = indices.map(i => results[i]);
+                subgroups.push({
+                    subgroup: ageGroup.name,
+                    patientCount: indices.length,
+                    concordance: subgroupResults.filter(r => r.concordance.regimenMatch || r.concordance.partialMatch).length / indices.length,
+                    responseAccuracy: this.calculateSubgroupResponseAccuracy(subgroupResults),
+                    medianPFS: this.calculateMedian(subgroupResults.map(r => r.outcomeComparison.actualPFS).filter(v => v !== undefined))
+                });
+            }
+        }
+        return subgroups;
+    }
+    /**
+     * Calculate response accuracy for a subgroup
+     */
+    calculateSubgroupResponseAccuracy(results) {
+        const withResponse = results.filter(r => r.outcomeComparison.responseCorrect !== undefined);
+        return withResponse.length > 0
+            ? withResponse.filter(r => r.outcomeComparison.responseCorrect).length / withResponse.length
+            : 0;
+    }
+    /**
+     * Validate and de-identify patient data
+     */
+    validateAndDeidentify(patient) {
+        // Generate hashed de-identified ID
+        const deidentifiedId = createHash('sha256')
+            .update(patient.id + 'SALT_CHANGE_IN_PRODUCTION')
+            .digest('hex')
+            .substring(0, 12);
+        return {
+            ...patient,
+            id: deidentifiedId
+        };
+    }
+    /**
+     * Generate validation report
+     */
+    generateReport(analysis) {
+        const lines = [
+            '═'.repeat(70),
+            '  RETROSPECTIVE VALIDATION REPORT',
+            '═'.repeat(70),
+            '',
+            `Cohort: ${analysis.cohortId}`,
+            `Patients: ${analysis.patientCount}`,
+            `Date Range: ${analysis.dateRange.start.toISOString().split('T')[0]} to ${analysis.dateRange.end.toISOString().split('T')[0]}`,
+            '',
+            '─'.repeat(70),
+            '  CONCORDANCE METRICS',
+            '─'.repeat(70),
+            `Full Concordance: ${(analysis.concordance.fullConcordance * 100).toFixed(1)}%`,
+            `Partial Concordance: ${(analysis.concordance.partialConcordance * 100).toFixed(1)}%`,
+            `No Concordance: ${(analysis.concordance.noConcordance * 100).toFixed(1)}%`,
+            '',
+            '─'.repeat(70),
+            '  PREDICTION ACCURACY',
+            '─'.repeat(70),
+            `Response Accuracy: ${(analysis.predictionAccuracy.responseAccuracy * 100).toFixed(1)}%`,
+            `Response Sensitivity: ${(analysis.predictionAccuracy.responseSensitivity * 100).toFixed(1)}%`,
+            `Response Specificity: ${(analysis.predictionAccuracy.responseSpecificity * 100).toFixed(1)}%`,
+            `PFS C-Index: ${analysis.predictionAccuracy.pfsCIndex.toFixed(3)}`,
+            `PFS Calibration: ${(analysis.predictionAccuracy.pfsCalibration * 100).toFixed(1)}%`,
+            `OS C-Index: ${analysis.predictionAccuracy.osCIndex.toFixed(3)}`,
+            `Toxicity Accuracy: ${(analysis.predictionAccuracy.toxicityAccuracy * 100).toFixed(1)}%`,
+            '',
+            '─'.repeat(70),
+            '  CLINICAL OUTCOMES',
+            '─'.repeat(70),
+            `Objective Response Rate: ${(analysis.clinicalImpact.objectiveResponseRate * 100).toFixed(1)}%`,
+            `Disease Control Rate: ${(analysis.clinicalImpact.diseaseControlRate * 100).toFixed(1)}%`,
+            `Median PFS: ${analysis.clinicalImpact.medianPFS.toFixed(1)} months`,
+            `Median OS: ${analysis.clinicalImpact.medianOS.toFixed(1)} months`,
+            '',
+            '  Concordant vs Discordant Treatment:',
+            `    Concordant ORR: ${(analysis.clinicalImpact.concordantVsDiscordant.concordantORR * 100).toFixed(1)}%`,
+            `    Discordant ORR: ${(analysis.clinicalImpact.concordantVsDiscordant.discordantORR * 100).toFixed(1)}%`,
+            `    Concordant Median PFS: ${analysis.clinicalImpact.concordantVsDiscordant.concordantMedianPFS.toFixed(1)} months`,
+            `    Discordant Median PFS: ${analysis.clinicalImpact.concordantVsDiscordant.discordantMedianPFS.toFixed(1)} months`,
+            '',
+            '─'.repeat(70),
+            '  SUBGROUP ANALYSES',
+            '─'.repeat(70),
+            ...analysis.subgroupAnalyses.map(sg => `${sg.subgroup}: n=${sg.patientCount}, Concordance=${(sg.concordance * 100).toFixed(0)}%, ` +
+                `Accuracy=${(sg.responseAccuracy * 100).toFixed(0)}%, mPFS=${sg.medianPFS.toFixed(1)}mo`),
+            '',
+            '═'.repeat(70)
+        ];
+        return lines.join('\n');
+    }
+    /**
+     * Export validation results
+     */
+    exportResults(cohortId, format) {
+        const patients = this.validationCohorts.get(cohortId);
+        if (!patients)
+            return '';
+        const results = [];
+        for (const patient of patients) {
+            const result = this.validationResults.get(patient.id);
+            if (result) {
+                results.push({
+                    patientId: patient.id,
+                    cancerType: patient.diagnosis.cancerType,
+                    stage: patient.diagnosis.stage,
+                    actualRegimen: patient.treatment.regimen,
+                    regimenMatch: result.concordance.regimenMatch,
+                    partialMatch: result.concordance.partialMatch,
+                    predictedResponse: result.outcomeComparison.predictedResponse,
+                    actualResponse: result.outcomeComparison.actualResponse,
+                    responseCorrect: result.outcomeComparison.responseCorrect,
+                    predictedPFS: result.outcomeComparison.predictedPFS,
+                    actualPFS: result.outcomeComparison.actualPFS,
+                    predictedOS: result.outcomeComparison.predictedOS,
+                    actualOS: result.outcomeComparison.actualOS,
+                    objectiveResponse: result.clinicalBenefit.objectiveResponse,
+                    diseaseControl: result.clinicalBenefit.diseaseControl
+                });
+            }
+        }
+        if (format === 'json') {
+            return JSON.stringify(results, null, 2);
+        }
+        // CSV format
+        const headers = Object.keys(results[0] || {});
+        const rows = [
+            headers.join(','),
+            ...results.map(r => headers.map(h => JSON.stringify(r[h] ?? '')).join(','))
+        ];
+        return rows.join('\n');
+    }
+}
+export default RetrospectiveValidationService;
+//# sourceMappingURL=retrospectiveValidator.js.map

package/dist/validation/retrospectiveValidator.js.map

@@ -0,0 +1 @@
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package/package.json

@@ -1,6 +1,6 @@
 {
   "name": "@erosolaraijs/cure",
-  "version": "1.0.0",
+  "version": "1.0.2",
   "description": "AI-powered unified cancer treatment framework with multi-provider support for medical research and patient care",
   "main": "dist/bin/cure.js",
   "type": "module",