Multiarm study comparing patient-reported and clinical outcome measures in patients undergoing antipsoriatic therapy with non-biological systemic agents in a real-world setting.

BACKGROUND: Although the inclusion of patients' preferences and needs is essential for therapy adherence, the assessment of patient-reported outcome measures in clinical trials is often neglected. Therefore, the aim of this study was to quantify several patient-reported outcome measures in psoriasis patients undergoing systemic therapy in a real-life clinical setting. METHODS: This clinical trial has been designed as a prospective, multiarm study to investigate the treatment satisfaction, adherence to therapy, quality of life (QoL), and clinical response in a real-life clinical setting during the initial 6 months of treatment with apremilast, methotrexate, and fumaric acids in 80 patients suffering from plaque psoriasis. RESULTS: The treatment satisfaction for the three systemic therapies was rated 'sufficient' with a mean (±SD) Treatment Satisfaction Questionnaire for Medication (TSQM) score of 275.0 (±62.7). Most potential for improvement was seen in the 'effectiveness' domain (54.3 ± 21.5). The highest treatment satisfaction level in all four domains (convenience, effectiveness, global satisfaction, and side-effects) was seen in the methotrexate group with a mean TSQM score of 306.3 ± 50.9, followed by apremilast (267.1 ± 61.6) and fumaric acids (254.9 ± 65.0; p = 0.005). Analysis of the TSQM revealed a considerable discrepancy between patient-reported clinical response and the actual Psoriasis Area and Severity Index (PASI) reduction. This applies equally to the patient- vs. physician-reported side-effects. CONCLUSIONS: This real-life study demonstrates that an adequate assessment of antipsoriatic drugs by PASI-reduction alone is not sufficient and underlines the importance of patient-reported outcome measures not only in clinical trials, but also for improved patient care.

Virtual and Augmented Reality in Cardiac Surgery

Abstract Virtual and augmented reality can be defined as a three-dimensional real-world simulation allowing the user to directly interact with it. Throughout the years, virtual reality has gained great popularity in medicine and is currently being adopted for a wide range of purposes. Due to its dynamic anatomical nature, permanent drive towards decreasing invasiveness, and strive for innovation, cardiac surgery depicts itself as a unique environment for virtual reality. Despite substantial research limitations in cardiac surgery, the current literature has shown great applicability of this technology, and promising opportunities.

Virtual and Augmented Reality in Cardiac Surgery.

Virtual and augmented reality can be defined as a three-dimensional real-world simulation allowing the user to directly interact with it. Throughout the years, virtual reality has gained great popularity in medicine and is currently being adopted for a wide range of purposes. Due to its dynamic anatomical nature, permanent drive towards decreasing invasiveness, and strive for innovation, cardiac surgery depicts itself as a unique environment for virtual reality. Despite substantial research limitations in cardiac surgery, the current literature has shown great applicability of this technology, and promising opportunities.

Phenotype, Function, and Mobilization of 6-Sulfo LacNAc-Expressing Monocytes in Atopic Dermatitis.

Mononuclear phagocytes (MPs) are important immune regulatory cells in atopic dermatitis (AD). We previously identified 6-sulfo LacNAc-expressing monocytes (slanMo) as TNF-α- and IL-23-producing cells in psoriatic skin lesions and as inducers of IFN-γ-, IL-17-, and IL-22-producing T cells. These cytokines are also upregulated in AD and normalize with treatment, as recently shown for dupilumab-treated patients. We here asked for the role of slanMo in AD. Increased numbers of slanMo were found in AD skin lesions. In difference to other MPs in AD, slanMo lacked expression of FcɛRI, CD1a, CD14, and CD163. slanMo from blood of patients with AD expressed increased levels of CD86 and produced IL-12 and TNF-α at higher amounts than CD14+ monocytes and myeloid dendritic cells. While CD14+ monocytes from patients with AD revealed a reduced IL-12 production, we observed no difference in the cytokine production comparing slanMo in AD and healthy controls. Interestingly, experimentally induced mental stress, a common trigger of flares in patients with AD, rapidly mobilized slanMo which retained their high TNF-α-producing capacity. This study identifies slanMo as a distinct population of inflammatory cells in skin lesions and as proinflammatory blood cells in patients with AD. slanMo may, therefore, represent a potent future target for treatment of AD.

Man against machine: diagnostic performance of a deep learning convolutional neural network for dermoscopic melanoma recognition in comparison to 58 dermatologists.

Background: Deep learning convolutional neural networks (CNN) may facilitate melanoma detection, but data comparing a CNN's diagnostic performance to larger groups of dermatologists are lacking. Methods: Google's Inception v4 CNN architecture was trained and validated using dermoscopic images and corresponding diagnoses. In a comparative cross-sectional reader study a 100-image test-set was used (level-I: dermoscopy only; level-II: dermoscopy plus clinical information and images). Main outcome measures were sensitivity, specificity and area under the curve (AUC) of receiver operating characteristics (ROC) for diagnostic classification (dichotomous) of lesions by the CNN versus an international group of 58 dermatologists during level-I or -II of the reader study. Secondary end points included the dermatologists' diagnostic performance in their management decisions and differences in the diagnostic performance of dermatologists during level-I and -II of the reader study. Additionally, the CNN's performance was compared with the top-five algorithms of the 2016 International Symposium on Biomedical Imaging (ISBI) challenge. Results: In level-I dermatologists achieved a mean (±standard deviation) sensitivity and specificity for lesion classification of 86.6% (±9.3%) and 71.3% (±11.2%), respectively. More clinical information (level-II) improved the sensitivity to 88.9% (±9.6%, P = 0.19) and specificity to 75.7% (±11.7%, P < 0.05). The CNN ROC curve revealed a higher specificity of 82.5% when compared with dermatologists in level-I (71.3%, P < 0.01) and level-II (75.7%, P < 0.01) at their sensitivities of 86.6% and 88.9%, respectively. The CNN ROC AUC was greater than the mean ROC area of dermatologists (0.86 versus 0.79, P < 0.01). The CNN scored results close to the top three algorithms of the ISBI 2016 challenge. Conclusions: For the first time we compared a CNN's diagnostic performance with a large international group of 58 dermatologists, including 30 experts. Most dermatologists were outperformed by the CNN. Irrespective of any physicians' experience, they may benefit from assistance by a CNN's image classification. Clinical trial number: This study was registered at the German Clinical Trial Register (DRKS-Study-ID: DRKS00013570; https://www.drks.de/drks_web/).

Extracorporeal life support with left ventricular decompression-improved survival in severe cardiogenic shock: results from a retrospective study.

OBJECTIVE: Extracorporeal life support (ECLS) is a life-saving procedure used in the treatment of severe cardiogenic shock. Within this retrospective single centre study, we examined our experience in this critically ill patient cohort to assess outcomes and clinical parameters by comparison of ECLS with or without selective left ventricular decompression. METHODS: Between 2004 and 2014 we evaluated 48 adult patients with INTERMACS level 1 heart failure (age 49.7 ± 19.5 years), who received either central ECLS with (n = 20, 41.7%) or ECLS without (n = 28, 58.3%, including 10 peripheral ECLS) integrated left ventricular vent in our retrospective single centre trial. RESULTS: Follow up was 100% with a mean of 0.83 ± 1.85 years. Bridge to ventricular assist device was feasible in 29.2% (n = 14), bridge to transplant in 10.4% (n = 5) and bridge to recovery in 8.3% (n = 4). Overall 30-day survival was 37.5%, 6-month survival 27.1% and 1-year survival 25.0%. ECLS support with left ventricular decompression showed favourable 30-day survival compared to ECLS without left ventricular decompression (p = 0.034). Thirty-day as well as long-term survival did not differ between the subgroups (central ECLS with vent, ECLS without vent and peripheral ECLS without vent). Multivariate logistic regression adjusted for age and gender revealed ECLS without vent as independent factor influencing 30-day survival. CONCLUSION: ECLS is an established therapy for patients in severe cardiogenic shock. Independent of the ECLS approach, 30-day mortality is still high but with superior 30-day survival for patients with ECLS and left ventricular venting. Moreover, by unloading the ventricle, left ventricular decompression may provide an important time window for recovery or further treatment, such as bridge to bridge or bridge to transplant.

Central Extracorporeal Life Support With Left Ventricular Decompression to Berlin Heart Excor: A Reliable "Bridge to Bridge" Strategy in Crash and Burn Patients.

The aim of this study was to compare patients with severe biventricular heart failure who underwent Berlin Heart Excor implantation with (cardiogenic shock [CS] status) or without the need for preoperative extracorporeal life support (ECLS) as a bridge to long-term device. A total of 40 consecutive patients with severe biventricular heart failure underwent Berlin Heart Excor implantation with (CS status, n = 20, 50%) or without (control, n = 20, 50%) the need for preoperative ECLS as a bridge to long-term device from March 2007 to May 2015 at our institution. Demographics and preoperative baseline characteristics as well as early and long-term outcomes including mortality and complication rates were retrospectively compared between the two groups. There were no statistically significant differences in terms of demographics and most preoperative clinical characteristics. The mean age in the ECLS (CS group) and control group was 43.5 ± 19.4 and 41.3 ± 16.4 (P = 0.705), whereas 20 and 25% of patients were females (P = 1.000). However, patients from the ECLS group had preoperatively higher lactate (P = 0.037), aspartate aminotransferase (P < 0.001), and alanine aminotransferase (P < 0.001) levels, all of them significantly decreased after surgery (P  = 0.004, P = 0.017, and P = 0.001, respectively) and did not show any statistical differences to the corresponding values from the control group (P = 0.597, P = 0.491, and P = 0.339, respectively). Postoperatively, patients from the control and ECLS groups had statistically similar incidences of liver failure (30 vs. 35%, P = 0.736), renal failure (45 vs. 70%, P = 0.110), need for reopening (35 vs. 60%, P = 0.113), major cerebrovascular events (35 vs. 30%, P = 0.736), sepsis (10 vs. 25%, P = 0.407), wound infection (20 vs. 30%, P = 0.716), abdominal ischemia requiring surgery (28.6 vs. 36.8%, P = 0.719), and acute respiratory distress syndrome (25 vs. 35.3%, P = 1.000). The proportion of patients who were bridged to transplantation was statistically similar between the ECLS and the control groups (40 vs. 52.6%, P = 0.429). Furthermore, there were no statistically significant differences in terms of early (Breslow [generalized Wilcoxon] P = 0.907) and long-term (log-rank [Mantel-Cox] P = 0.787) overall cumulative survival accounting for 30-day survival of 75 versus 75%, 6-month survival of 60 versus 55%, 1-year survival of 54 versus 40%, and 7-year survial of 47 versus 40% in the control and ECLS groups, respectively. ECLS in critical CS as a bridge to implantation of the Berlin Heart Excor ventricular assist device is safe and is associated with improvement in end-organ function leading to similar excellent early and long-term survival and incidences of major complications as in patients without the need for preoperative ECLS support.