Use of hospital big data to optimize and personalize laboratory test interpretation with an application.

BACKGROUND AND AIMS: In laboratory medicine, test results are generally interpreted with 95% reference intervals but correlations between laboratory tests are usually ignored. We aimed to use hospital big data to optimize and personalize laboratory data interpretation, focusing on platelet count. MATERIAL AND METHODS: Laboratory tests were extracted from the hospital database and exploited by an algorithmic stepwise procedure. For any given laboratory test Y, an "optimized and personalized reference population" was defined by keeping only patients whose laboratory values for all Y-correlated tests fell within their own usual reference intervals, and by partitioning groups by individual-specific variables like sex and age category. The method was applied to platelet count. RESULTS: Laboratory data were recorded for 28,082 individuals. At the end of the algorithmic process, seven correlated laboratory tests were chosen, resulting in a reference sample of 159 platelet counts. A new 95 % reference interval was constructed [152-334 × 109/L], notably reduced (27.2 %) compared to conventional reference values [150-400 × 109/L]. The reference interval was validated on a sample of 2,129 patients from another downtown laboratory, emphasizing the potential transference of the hospital-derived reference limits. CONCLUSION: This method offers new perspectives in laboratory data interpretation, especially in patient screening and longitudinal follow-up.

Esketamine nasal spray in patients with treatment-resistant depression: the real-world experience in the French cohort early-access programme.

OBJECTIVE: To present the first real-world data of patients with treatment-resistant depression (TRD) treated with esketamine through a French cohort Temporary Authorisation for Use (ATUc) programme. METHODS: In 2019, the French Health Authorities exceptionally granted the first ATUc in psychiatry for TRD patients. Clinical characteristics, safety and efficacy data were reported by physicians. The ATUc ended ∼6 months after initiation. RESULTS: The cohort (n = 66; median age 53.0 years; 62.1% female; 78.8% with severe major depressive episodes; resistance to a mean of 4.2 previous antidepressants) received esketamine treatment for a median of 30 days. Among 46 analysed patients, 22 (47.8%) achieved response (Montgomery-Åsberg Depression Rating Scale [MADRS] total score reduction ≥50.0%) and 17 (37.0%) achieved remission (MADRS total score of ≤12) at least once at a median of 18.5 (2.0-77.0) and 21.0 (2.0-46.0) days after initiation, respectively. By Week 4, patients had a 31.6% probability of achieving remission (Kaplan-Meier method). Sedation, somnolence, dizziness, hypertension, anxiety and dissociation were the most frequently reported (>10.0%) adverse events. No new safety signals were identified. CONCLUSIONS: Patient characteristics of this cohort demonstrate high-level treatment resistance. The safety and efficacy of esketamine in patients with TRD in real-world clinical practice were consistent with Phase 3 trials.Key pointsPatients with treatment-resistant depression (TRD) exceptionally received esketamine nasal spray ahead of its launch through a French cohort Temporary Authorisation for Use (ATUc) programme.The clinical characteristics of 66 adult patients with TRD included in this cohort demonstrated a high-level of resistance to conventional treatments at the time of treatment request prior to esketamine initiation.No new safety signals were observed with esketamine initiation during the ATUc period compared with the Phase 3 clinical trials.The safety and efficacy of esketamine in the real world remain consistent with that established in Phase 3 clinical trials.The data collected during this ATUc also provide the first real-world data on the management and practical use of esketamine in a hospital setting in France.