Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia.

Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches.

Our results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety.

Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.

Major depressive disorder (MDD) is a debilitating disease in Italy affects 5.4% of people over 15 and 11.6% for the elderly. Efficacy of vortioxetine in adult patients with MDD was demonstrated in randomised controlled trials, there is a need for data on treatment in daily practice in Italy.

To present the effectiveness and safety data of vortioxetine in real-world setting from patients enrolled from Italy in the RELIEVE study.

RELIEVE was a prospective, multi-national, observational study of outpatients initiating vortioxetine treatment for MDD at physician’s discretion. Data and outcomes of treatment of patients were collected at routine clinical visits. The primary outcome was functioning measured by SDS. Secondary outcomes included depressive symptoms measured by PHQ-9, cognitive funcion measured by PDQ-5, quality of life measured by EQ-5D-5L. Changes from baseline to month 6 were estimated with a linear mixed model of repeated measures approach.

A total of 231 patients (mean age, 55.5 years, 27.3% over 65 years, 62% female) were enrolled from Italy and included in the analysis. Mean(SD) SDS total score, PHQ-9, PDQ-5 scores at baseline were 17.8(7.58), 15.7(5.97) and 9.8(4.99), the scores(SE) decreased by 6.6(0.64), 5.9(0.47) and 3.6(0.36) from baseline to last visit. Mean(SE) EQ-5D-5L utility index increased by 0.13(0.01). Safety and tolerability profile of vortioxetine was in line with the established profile.

Improvements in overall functioning, depressive symptoms, cognitive function and quality of life were observed in patients treated with vortioxetine, including a wide proportion of elderly patients in a real-world setting.

A. Pugliese is an employee of Lundbeck Italy. K. Simonsen and H. Ren are employees of H. Lundbeck A/S.

Major depressive disorder (MDD) affects around 10% of the French population annually and significantly impacts patient functioning. Efficacy of vortioxetine was demonstrated in randomised controlled trials, data on its real-world performance is needed.

To describe the effectiveness and safety of vortioxetine in real-world setting from patients enrolled from France in the global RELIEVE study.

RELIEVE was a prospective, multi-national, observational study of outpatients initiating vortioxetine treatment for MDD at physician’s discretion. Data were collected at routine clinical visits. Here we present the outcomes of treatment of patients in France. The primary outcome was functioning measured by SDS. Secondary outcomes included depressive symptoms measured by PHQ-9, cognitive symptoms measured by PDQ-5 and DSST. Changes from baseline to month 6 were estimated with a linear mixed model of repeated measures approach.

A total of 184 patients (mean age, 50.2 years, 65% female, 67.9% of patients had at least one comorbidity) were enrolled from France and included in the analysis. Mean(SD) SDS total score, PHQ-9, PDQ-5 scores at baseline were 21.1(5.4), 17.5(4.7) and 11.7(4.4), the scores(SE) decreased by 10.9(0.59), 9.3(0.48) and 6.1(0.37) from baseline to month 6. Mean(SD) DSST improved from 41.6(15.2) at baseline to 49.1(19.0) at month 6. Safety and tolerability profile of vortioxetine was in line with previous studies.

Sustained improvements in overall functioning, depressive symptoms, cognitive function were observed in patients treated with vortioxetine in a real-world setting, which provided further evidence of effectiveness and safety of vortioxetine in a broad MDD population in France.

M. Rabbani is an employee of Lundbeck France. K. Simonsen and H. Ren are employees of H. Lundbeck A/S.

Goal attainment scaling (GAS) is a method to assess the patient experience of whether a treatment is successful and capture outcomes across a diverse range of goal areas. However, this approach has not yet been used in assessing the treatment of Major Depressive Disorder (MDD) in Japan. GAS was first developed by Kiresuk and Sherman in the 1968, it is increasingly recognised as a sensitive method for recording patient-centred outcomes throughout the course of treatment.

To demonstrate the effectiveness of vortioxetine on patient’s goal achievement and depressive symptoms, emotional, cognitive, overall function and quality of life.

VGOAL-J is a prospective, multi-center, observational cohort study of outpatients initiating vortioxetine treatment for MDD in Japan. Patients with a diagnosis of MDD according to DSM-5 who are 18 to 65 years will be enrolled from 20 sites in Japan and followed for 24 weeks. A total number of 120 patients is planned for enrolment. Primary outcome measures are GAS-D, WPAI, secondary outcome measures include Montgomery – Åsberg Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), Perceived Deficits Questionnaire-Depression 5-item (PDQ-D-5), Oxford Depression Questionnaire (ODQ), EuroQol-5 Dimension (EQ-5D). Safety will be also assessed with Adverse Events collected during the study.

The results will be disseminated in late 2022 and provide new insights on GAS-D as an effective strategy to assess MDD treatment in Japan.

We expect to observe patients treated with vortioxetine achieving their treatment goals as assessed by GAS-D and improvements on patient- and clinician-reported measures in real-world settings.

Prof. K. Watanabe reports consultancies undertaken for Eli Lilly, Otsuka Pharmaceutical, Sumitomo Dainippon Pharma, Taisho Toyama Pharmaceutical, and Takeda Pharmaceutical, honoraria received from Daiichi Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, J

Esketamine nasal spray has been developed to treat adults with treatment resistant depression. On Dec.2019, EMA granted a market access approval in this indication.

ESKALE is a descriptive study of treatment resistant depression patients treated with esketamine in France.

Observational retrospective study. 157 patients are included in 3 cohorts depending on their treatment initiation date. This abstract presents the second interim results of patients treated with esketamine and whom data collection ranges from Oct.2019 and Sept.2021.

66.7% of patients were females. Average age was 49 years old with 26 patients > 65 years old. Duration of the current depressive episode was 26.0 months (mean). 48.8% of patient have > 1 suicide attempt during whole life. At esketamine initiation, 78.2% patients were clinically perceived to have severe depression with a MADRS score of 32.4 (median) and a PHQ9 score of 19.5 (median). For the overall sample, esketamine was prescribed in median as a 3rd line and for 40.5% of patients after neurostimulation. The majority of the patient started esketamine at 28 mg or 56 mg and increased the dose to 84 mg. After 4 months of treatment, clinical benefits are the following: decrease of MADRS total score -16.5 points (median) corresponding to 58% of responders and a PHQ9 total score decrease of -8.6 points (median). No new safety signal detected.

This second interim analysis describes patients’ profiles and clinical evolution over a longer period and a broader population than the first interim analysis. The conditions of use are consistent with the ones approved by health authorities.

I (Marie-Alix Codet) works as a full employee at Janssen Cilag

Vortioxetine has demonstrated sustained efficacy and favorable safety profile in multiple clinical trials.

This study aims to describe the effectiveness and safety of vortioxetine in real-world clinical practice.

RELIEVE is a prospective, multi-national, observational cohort study of outpatients initiating vortioxetine treatment for MDD at physician’s discretion and followed for 6 months. Data were collected at routine clinical visits. The primary outcome was functioning measured by Sheehan Disability Scale (SDS). Depressive symptoms measured by Patient Health Questionnaire 9-item (PHQ-9), cognitive symptoms measured by PDQ-5 and DSST were key secondary outcomes. Safety outcomes including adverse events were reported. This interim analysis presents results of 527 patients who completed the study and were followed for 6 months. Mixed models of repeated measures were used to assess improvements between baseline and month 6, adjusted for relevant confounders.

A total of 527 patients (mean age, 50.2 years, 65% female) were enrolled from US, Canada, France and Italy, and included in the analysis. Mean SDS total score, PHQ-9, PDQ-5 scores decreased by 8.6, 7.4 and 4.7 respectively from baseline to last visit. Mean DSST score improved by 6.5 from baseline to last visit. Patients’ overall functioning and quality of life significantly improved, sick leave days and underproductive days (both absenteeism and presenteeism) decreased over the entire follow up period. The overall incidence of adverse events(AE) was 25%, with the most common AEs being nausea and headache.

The results confirm the effectiveness and good tolerability of vortioxetine in a broad range of patients in routine clinical practice.

Dr. Mattingly has served as researcher, consultant or speaker for Akili, Alcobra, Alkermes, Allergan, Axsome, Boehringer, Forum, Genentech, Jansen, Lundbeck, Medgenics, Merck, Neos, NLS Pharma, Otsuka, Reckitt Benckiser, Roche, Sage, Shire, Sunovion, Supe