A Novel Sensor-Based Application for Home-Based Rehabilitation Can Objectively Measure Postoperative Outcomes following Anterior Cruciate Ligament Reconstruction.

In order to successfully implement individualized patient rehabilitation and home-based rehabilitation programs, the rehabilitation process should be objectifiable, monitorable and comprehensible. For this purpose, objective measurements are required in addition to subjective measurement tools. Thus, the aim of this prospective, single-center clinical trial is the clinical validation of an objective, digital medical device (DMD) during the rehabilitation after anterior cruciate ligament reconstruction (ACLR) with regards to an internationally accepted measurement tool. Sixty-seven patients planned for primary ACLR (70:30% male-female, aged 25 years [21-32], IKDC-SKF 47 [31-60], Tegner Activity Scale 6 [4-7], Lysholm Score 57 [42-72]) were included and received physical therapy and the DMD after surgery. For clinical validation, combined measures of range of motion (ROM), coordination, strength and agility were assessed using the DMD in addition to patient-reported outcome measures (PROMs) at three and six months after ACLR. Significant correlations were detected for ROM (rs = 0.36-0.46, p < 0.025) and strength/agility via the single-leg vertical jump (rs = 0.43, p = 0.011) and side hop test (rs = 0.37, p = 0.042), as well as for coordination via the Y-Balance test (rs = 0.58, p ≤ 0.0001) regarding the IKDC-SKF at three months. Additionally, DMD test results for coordination, strength and agility (Y-Balance test (rs = 0.50, p = 0.008), side hop test (rs = 0.54, p = 0.004) and single-leg vertical jump (rs = 0.44, p = 0.018)) correlate significantly with the IKDC-SKF at six months. No adverse events related to the use of the sensor-based application were reported. These findings confirm the clinical validity of a DMD to objectively quantify knee joint function for the first time. This will have further implications for clinical and therapeutic decision making, quality control and monitoring of rehabilitation measures as well as scientific research.

Sensor-based telerehabilitation system increases patient adherence after knee surgery.

OBJECTIVES: Implementing evidence-based recommendations with the option of patient-individualised and situation-specific adaptations in telerehabilitation may increase adherence with improved clinical outcome. METHODS: As part of a registry-embedded hybrid design (part 1), digital medical device (DMD)-usage in a home-based setting was analysed in a multinational registry. The DMD combines an inertial motion-sensor system with instructions for exercises and functional tests on smartphones. A prospective, single-blinded, patient-controlled, multicentre intervention study (DRKS00023857) compared implementation capacity of the DMD to standard physiotherapy (part 2). Usage patterns by health care providers (HCP) were assessed (part 3). RESULTS AND CONCLUSION: Registry raw data (10,311 measurements) were analysed from 604 DMD-users, demonstrating clinically expected rehabilitation progression post knee injuries. DMD-users performed tests for range-of-motion, coordination and strength/speed enabling insight to stage-specific rehabilitation (χ2 = 44.9, p<0.001). Intention-to-treat-analysis (part 2) revealed DMD-users to have significantly higher adherence to the rehabilitation intervention compared to the matched patient-control-group (86% [77-91] vs. 74% [68-82], p<0.05). DMD-users performed recommended exercises at home with higher intensity (p<0.05). HCP used DMD for clinical decision making. No adverse events related to the DMD were reported. Adherence to standard therapy recommendations can be increased using novel high quality DMD with high potential to improve clinical rehabilitation outcome, enabling evidence-based telerehabilitation.

Ultrasonography for quantitative assessment of knee joint effusions-useful tool for objective evaluation of rehabilitation progress?

PURPOSE: We sought to externally validate ultrasonography (US) for quantification of suprapatellar effusion size to improve diagnosis and individualised rehabilitation strategies in knee rehabilitation after anterior cruciate ligament reconstruction (ACLR) surgery. METHODS: US was performed on 35 patients as part of the ongoing CAMOPED study. Data were collected in ACLR and post surgery in defined intervals up to one year post-operation. The palpatory assessment was graded using the International Knee Documentation Committee (oIKDC). RESULTS: In a total of 164 sonographies, a strong correlation between palpatory and US effusion (r = 0.83, p < 0.01) with lower deviations in US quantification compared to palpatory quantification Y = 1.15 + 0.15* x was seen. Threshold values could be determined for the detection of effusions by palpation and for the differentiation between mild and moderate/severe effusions (effusion depth: 2.6 mm and resp. 5.8 mm, respectively). CONCLUSIONS: As demonstrated in this multicenter study, the size of suprapatellar effusions can be easily quantified with high accuracy using standardised bedside ultrasound. Especially in moderate to severe effusions, US provides a practical and reliable tool for outcome measurement superior to palpatory assessment with the goal of optimising individual recommendations during the rehabilitation course. Furthermore, for the first time, it has been possible to define sonographic threshold values for the detection of effusion and differentiation of mild vs. moderate/severe effusion by means of palpation.

Dynamic Standing Exercise using the Innowalk Device in Patients with Genetic and Acquired Motor Impairments.

OBJECTIVE: For individuals with motor impairments, dynamic standing has been proposed as an opportunity for regular daily physical activity. The aim of this study was to analyse patient characteristics, indications, intensity of usage, desired objectives and outcomes of dynamic standing in daily clinical practice in order to form the basis for research regarding this treatment option. SETTING: Data were analysed from standardized questionnaires completed prospectively before supply of a home-based medical device for dynamic standing (Innowalk; Made for Movement GmbH, Langenhagen, Germany) and at the time of individual adaptations. PARTICIPANTS: In a retrospective chart analysis, records of 46 patients (50% cerebral palsy; 50% diverse syndromes) were evaluated. INTERVENTION: The Innowalk had been prescribed for either home-based use (n = 31), in therapeutic institutions (n = 8), or other settings (n = 7). Dynamic standing was performed for 10-30 min as a single session (n = 8) or for 20-60 min 11 [4-21] weeks in 36 patients. RESULTS: Improvements were found for: passive assisted motion (79%), stimulation of intestinal functions (71%), body stability (64%), joint mobility (56%), secure means of allowing supine position (52%), and revision of abnormal motion patterns (48%). CONCLUSION: Thus, this systematic approach shows usage patterns, indications, desired goals and clinical outcome of dynamic standing in daily clinical practice and forms the basis for the design of a prospective, randomized controlled trial.

Prevalence and influencing factors of chronic post-traumatic stress disorder in patients with myocardial infarction, transient ischemic attack (TIA) and stroke - an exploratory, descriptive study.

BACKGROUND: Cardio- and cerebrovascular events such as myocardial infarction (MI), stroke and transient ischemic attack (TIA) are leading causes of death and disability and have also been associated with poor mental outcomes. In addition, cardio- and cerebrovascular events may pose the risk of experiencing a sudden traumatic occurrence of symptoms during ictus and thus contribute to high rates of PTSD as well as high rates of subsequent depression and anxiety. Moreover, MI, TIA and stroke survivors with PTSD, depressive and anxiety symptoms may have poorer health-related quality of life (HRQoL) and poorer disease prognosis than patients who do not develop psychiatric symptoms after ictus. However, data on the prevalence of PTSD, anxiety and depression, as well as the HRQoL, coping strategies and potential risk factors for development of PTSD in these patients, are rare. METHODS: In an exploratory, descriptive study we interviewed 112 patients (54 MI, 18 TIA, 40 stroke; mean age: 69.5 years, 55.4% males) from three general physician practices and used psychometric self-assessment tools to determine the occurrence of PTSD and psychosomatic comorbidity, anxiety and depression and to assess HRQoL and coping strategies. We evaluated disease severity and compared the patient groups to each other. Moreover, we assessed psychological outcome differences between patients with or without PTSD after ictus. RESULTS: The prevalence of PTSD after MI, TIA and stroke was 23.2%. The patients who developed PTSD had higher rates of depression, anxiety and maladaptive coping as well as reduced HRQoL. Adaptive coping was positively related to better mental HRQoL and negatively related to anxiety and depression. Disease severity of MI, TIA and stroke was not related to PTSD, depression, anxiety or physical HRQoL. CONCLUSIONS: Experiencing MI, TIA or stroke means confronting a life-threatening event for those affected and, therefore, these can be regarded as traumatic events. Cerebral and cardiovascular events increase the risk of developing chronic PTSD with subsequent increased depression and anxiety and reduced HRQoL. These findings emphasize the need for early screening and diagnosis of PTSD in somatically ill patients, which should be followed by specialized treatment, as PTSD hampers overall (somatic) disease prognosis. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00021730, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021730 , registered 05/19/2020 - Retrospectively registered.

Occurence of Post-Traumatic Stress Symptoms, Anxiety and Depression in the Acute Phase of Transient Ischemic Attack and Stroke.

Rates of post-traumatic stress symptoms, anxiety and depression are increased in patients having experienced a transient ischemic attack (TIA) or stroke several months ago. However, data of psychiatric symptoms in the acute phase within the first days after ictus are lacking. In 20 patients with stroke and 33 patients with TIA we assessed disease severity by means of the NIHSS, levels of depression and anxiety by HADS, PTSD-like symptoms by PC-PTSD, quality of life (HrQoL) by SF-12, and coping style by brief COPE Inventory within the first 5 days after ictus. NIHSS on admission was lower in patients with TIA (0 ± 1) than in patients with stroke (3 ± 2, p < 0.001). HADS depression score was significantly higher in patients with stroke (7.0 ± 4.5) than in patients with TIA (4.9 ± 4.0). HADS anxiety score, HrQoL and coping styles were similar between TIA and stroke patients (p > 0.05). 5 and 3 of 33 TIA patients as well as 4 and 3 of 20 stroke patients had at least 11 points in the HADS anxiety and depression score respectively (p = 0.001). 2 of 33 TIA patients and 2 of 20 stroke patients had more than 2 points in the PC-PTSD (p = 0.646). We did not find consistent correlations between the NIHSS and the psychometric parameters. Within the first five days after patients having experienced a TIA or stroke PTSD-like, anxious and depressive symptoms are more common than in the general population. As the acute psychological status after ictus is predictive for psychiatric comorbidity years later physicians should pay attention and adequately treat psychiatric symptoms already in the acute phase of stroke.Trial Registration: German Clinical Trials Register, DRKS00021730, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021730 , registered 05/19/2020- Retrospectively registered.

Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study.

INTRODUCTION: The Comparison of Methylphenidate and Psychotherapy in adult ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial, comparing methylphenidate (MPH) with placebo (PLAC) in combination with cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM) over the period of 1 year. Here, we report results on treatment safety. METHODS: MPH and PLAC were flexibly dosed. Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an "as received" basis during week 0-52. Electrocardiogram data were recorded at baseline and week 24. RESULTS: Comparing 205 patients who received ≥1 dose of MPH with 209 patients who received PLAC, AEs occurring significantly more frequently in the MPH group were decreased appetite (22 vs. 3.8%), dry mouth (15 vs. 4.8%), palpitations (13 vs. 3.3%), gastrointestinal infection (11 vs. 4.8%), agitation (11 vs. 3.3%), restlessness (10 vs. 2.9%), hyperhidrosis, tachycardia, weight decrease (all 6.3 vs. 1.9%), depressive symptom, influenza (both 4.9 vs. 1.0%), and acute tonsillitis (4.4 vs. 0.5%). Syncope occurred significantly more often in the PLAC group (2.4 vs. 0%). Clinically relevant ECG changes occurred very rarely in both groups. Serious AEs were rare and without a significant group difference. The comparison of 206 patients treated with GPT versus 209 patients who received CM revealed no major differences. Serious AE classified as psychiatric occurred in 5 cases in the CM group and in 1 case in the GPT group. CONCLUSION: In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated.

Kidney-transplant patients receiving living- or dead-donor organs have similar psychological outcomes (findings from the PI-KT study).

PURPOSE: Kidney transplantation (KT) is the treatment of choice for end-stage chronic kidney disease (CKD) and is well known to improve the clinical outcome of patients. However, the impact of KT on comorbid psychological symptoms, particularly depression and anxiety, is less clear, and recipients of living-donor (LD) organs may have a different psychological outcome from recipients of dead-donor (DD) organs. DESIGN/METHODOLOGY/APPROACH: In total, 152 patients were included and analyzed using a cross-sectional design. Of these patients, 25 were pre-KT, 13 were post-KT with a LD transplant and 114 were post-KT with a DD transplant. The patients were tested for a variety of psychometric outcomes using the Hospital Anxiety and Depression Scale, the 12-Item Short Form Health Survey (assessing physical and mental health-related quality of life), the Resilience Scale, the Coping Self-Questionnaire and the Social Support Questionnaire. FINDINGS: The mean age of the patients was 51.25 years and 40 per cent of the patients were female. As expected, the post-KT patients had significantly better scores on the physical component of the Short Form Health Survey than the pre-KT patients, and there were no significant differences between the two post-KT groups. There were no significant differences among the groups in any of the other psychometric outcome parameters tested, including anxiety, depression and the mental component of health-related quality of life. RESEARCH LIMITATIONS/IMPLICATIONS: KT and the origin of the donor organ do not appear to have a significant impact on the psychological well-being of transplant patients with CKD. Although the diagnosis and early treatment of psychological symptoms, such as depression and anxiety, remain important for these patients, decisions regarding KT, including the mode of transplantation, should not be fundamentally influenced by concerns about psychological impairments at the population level. ORIGINALITY/VALUE: CKD is a serious condition involving profound impairment of the physical and psychological well-being of patients. KT is considered the treatment of choice for most of these patients. KT has notable advantages over dialysis with regard to the long-term physical functioning of the renal and cardiovascular system and increases the life expectancy of patients. However, the data on the improvement of psychological impairments after KT are less conclusive.

Update on structured pain assessment for the documentation of diagnosis-independent symptoms and signs associated with pain.

Concerning the diagnosis and therapy of pain syndromes, standardized descriptions similar to those used in the examination of psychopathological findings via the system produced by the AMDP ("Arbeitsgemeinschaft für Methodik und Dokumentation in der Psychiatrie", i. e., the working group establishing standardized methodology and documentation within psychiatry) are still lacking. Therefore, the authors of this article have founded a working group to establish standardized methodology and documentation for symptoms and signs associated with pain, although not at a diagnosis-specific level, in order to promote standardization in the documentation of pain and rating of the symptoms associated with a given set of medical results. This article presents a system for documenting the symptoms and signs associated with pain globally and independently of the diagnosis (Structured Pain Assessment System) with nomenclature that is inspired by the AMDP system. The objective of this working group is to develop documentation for a uniform multidimensional pain assessment (with defined terminology) that serves as a comparable and unified standard in the field.

Patients with cervical intraepithelial neoplasms show different states of health-related quality of life and different coping styles depending on the choice of therapy: findings from the CIN study.

PURPOSE: To examine the effects of type of therapy (conservative therapy vs conization) on the psychosocial well-being of patients with cervical intraepithelial neoplasia grade II (CIN II) in a prospective cross-sectional study designed to simplify future choice of therapy. PATIENTS AND METHODS: In a cross-sectional study comparing 24 CIN II patients who were treated via conservative therapy with 17 CIN II patients who were treated via conization (not randomized), we examined the association between therapy type and psychosocial well-being after the treatment. Scores on the Hospital Anxiety and Depression Scale (HADS) (prevalence of depression/anxiety), SF-12 (health-related quality of life (HRQoL)) and Brief COPE (coping mechanisms) questionnaires were compared between the two subgroups via nonparametric Mann-Whitney U-tests. RESULTS: The prevalence of depression/anxiety and mental HRQoL did not differ between patients undergoing conservative therapy and those undergoing conization but differed significantly from those of the healthy population. Regarding physical HRQoL and coping strategies, the conservative therapy subgroup achieved higher scores and better performance. CONCLUSION: Patients with CIN II are at risk of developing depressive or anxiety symptoms. The choice of therapy seems to have an influence on physical HRQoL and coping strategies but not on depression/anxiety and mental HRQoL.

Effect of assisted walking-movement in patients with genetic and acquired neuromuscular disorders with the motorised Innowalk device: an international case study meta-analysis.

People with physical disabilities (PD) suffer from consequences due to lack of physical activity and consequently, are at increased risk of chronic diseases. We aimed to evaluate the ability of a motorised assistive device for dynamic standing with weight-bearing in addition to standard state-of-the-art therapy to improve clinical outcome in a meta-analysis of available studies. A total of 11 studies were identified from different European countries analysing the effect of the dynamic device Innowalk. Raw data of nine studies were pooled including a total of 31 patients observed between 2009 and 2017. Standardised questionnaires and physical outcomes were examined in this exploratory meta-analysis. We recorded patients' characteristics, duration, intensity, and location of usage as well as general clinical outcomes and improvement of passive range of motion (PROM). The analysed population consisted in 90% cases of patients younger than 18 years of age. Patients were severely disabled individuals (aged 8 (6-10) years; 58% male; 67% non-ambulatory, 86% cerebral palsy). A total of 94% used the Innowalk in a home-based or day-care setting. For nearly all individuals (94%), improvements were recorded for: walking or weight-bearing transfer (n = 13), control/strength of the trunk or head (n = 6), joint mobility (n = 14), sleep (n = 4 out of 6/67%), or muscle strength (n = 17), vital functions (n = 16), bowel function (n = 10), attention/orientation (n = 2). PROM of the hip (flexion, abduction, and adduction) significantly (p < 0.001 for multiple comparisons) increased after 1 month (p < 0.05 flexion, adduction) and further after 5 months (p < 0.05 each) in contrast (p < 0.05 each) to a control group with state-of-the-art therapy. Similarly, PROM showed a trend towards improvement in dorsal extension of the ankle (p = 0.07). In summary, this is the first report of a novel device with additional benefit to standard therapy for severe PD. These intriguing results warrant the planned prospective randomised controlled trial to prove the concept and mechanism of action of this device.

Long-term Effects of Multimodal Treatment on Adult Attention-Deficit/Hyperactivity Disorder Symptoms: Follow-up Analysis of the COMPAS Trial.

Importance: Knowledge about the long-term effects of multimodal treatment in adult attention-deficit/hyperactivity disorder (ADHD) is much needed. Objective: To evaluate the long-term efficacy of multimodal treatment for adult ADHD. Design, Setting, and Participants: This observer-masked, 1.5-year follow-up of the Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS), a prospective, multicenter randomized clinical trial, compared cognitive behavioral group psychotherapy (GPT) with individual clinical management (CM) and methylphenidate (MPH) with placebo (2 × 2 factorial design). Recruitment started January 2007 and ended August 2010, and treatments were finalized in August 2011 with follow-up through March 2013. Overall, 433 adults with ADHD participated in the trial, and 256 (59.1%) participated in the follow-up assessment. Analysis began in November 2013 and was completed in February 2018. Interventions: After 1-year treatment with GPT or CM and MPH or placebo, no further treatment restrictions were imposed. Main Outcomes and Measures: The primary outcome was change in the observer-masked ADHD Index of Conners Adult ADHD Rating Scale score from baseline to follow-up. Secondary outcomes included further ADHD rating scale scores, observer-masked ratings of the Clinical Global Impression scale, and self-ratings of depression on the Beck Depression Inventory. Results: At follow-up, 256 of 433 randomized patients (baseline measured in 419 individuals) participated. Of the 256 patients participating in follow-up, the observer-masked ADHD Index of Conners Adult ADHD Rating Scale score was assessed for 251; the mean (SD) baseline age was 36.3 (10.1) years; 125 patients (49.8%) were men; and the sample was well-balanced with respect to prior randomization (GPT and MPH: 64 of 107; GPT and placebo: 67 of 109; CM and MPH: 70 of 110; and CM and placebo: 55 of 107). At baseline, the all-group mean ADHD Index of Conners Adult ADHD Rating Scale score was 20.6, which improved to adjusted means of 14.2 for the GPT arm and 14.7 for the CM arm at follow-up with no significant difference between groups (difference, -0.5; 95% CI, -1.9 to 0.9; P = .48). The adjusted mean decreased to 13.8 for the MPH arm and 15.2 for the placebo arm (difference, -1.4; 95% CI, -2.8 to -0.1; P = .04). As in the core study, MPH was associated with a larger reduction in symptoms than placebo at follow-up. These results remained unchanged when accounting for MPH intake at follow-up. Compared with participants in the CM arm, patients who participated in group psychotherapy were associated with less severe symptoms as measured by the self-reported ADHD Symptoms Total Score according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) of Conners Adult ADHD Rating Scale (AMD, -2.1; 95% CI, -4.2 to -0.1; P = .04) and in the subscale of reducing pure hyperactive symptoms, measured via the Diagnostic Checklist for the diagnosis of ADHD in adults (AMD, -1.3; 95% CI, -2.8 to 0.1; P = .08). Regarding the Clinical Global Impression scale assessment of effectiveness, the difference between GPT and CM remained significant at follow-up (odds ratio, 1.63; 95% CI, 1.03-2.59; P = .04). No differences were found for any comparison concerning depression as measured with the Beck Depression Inventory. Conclusions and Relevance: Results from COMPAS demonstrate a maintained improvement in ADHD symptoms for adults 1.5 years after the end of a 52-week controlled multimodal treatment period. The results indicate that MPH treatment combined with GPT or CM provides a benefit lasting 1.5 years. Confirming the results of the core study, GPT was not associated with better results regarding the primary outcome compared with CM. Trial Registration: isrctn.org Identifier: ISRCTN54096201.

Telbivudine Reduces Parvovirus B19-Induced Apoptosis in Circulating Angiogenic Cells.

Aims: Human parvovirus B19 (B19V) infection directly induces apoptosis and modulates CXCR4 expression of infected marrow-derived circulating angiogenic cells (CACs). This leads to dysfunctional endogenous vascular repair. Treatment for B19V-associated disease is restricted to symptomatic treatment. Telbivudine, a thymidine analogue, established in antiviral treatment for chronic hepatitis B, modulates pathways that might influence induction of apoptosis. Therefore, we tested the hypothesis of whether telbivudine influences B19V-induced apoptosis of CAC. Methods and Results: Pretreatment of two CAC-lines, early outgrowth endothelial progenitor cells (eo-EPC) and endothelial colony-forming cells (ECFC) with telbivudine before in vitro infection with B19V significantly reduced active caspase-3 protein expression (-39% and -40%, both p < 0.005). Expression of Baculoviral Inhibitor of apoptosis Repeat-Containing protein 3 (BIRC3) was significantly downregulated by in vitro B19V infection in ECFC measured by qRT-PCR. BIRC3 downregulation was abrogated with telbivudine pretreatment (p < 0.001). This was confirmed by single gene PCR (p = 0.017) and Western blot analysis. In contrast, the missing effect of B19V on angiogenic gene expression postulates a post-transcriptional modulation of CXCR4. Conclusions: We for the first time show a treatment approach to reduce B19V-induced apoptosis. Telbivudine reverses B19V-induced dysregulation of BIRC3, thus, intervening in the apoptosis pathway and protecting susceptible cells from cell death. This approach could lead to an effective B19V treatment to reduce B19V-related disease.

Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression.

Vagus nerve stimulation (VNS) is an approved neurostimulation therapy. The purpose of the method is to treat patients with therapy-resistant depression (TRD). VNS exhibits antidepressive and stabilizing effects. This method is particularly useful as a long-term treatment, in which up to two-thirds of patients respond. The vagus nerve stimulator is positioned on the left vagus nerve during a surgical procedure and is activated telemetrically by a wand connected to a handheld computerized device. The treating physician can perform various adjustments of the vagus nerve stimulator during in-office visits (e.g., by modifying stimulation intensity or stimulation frequency) to achieve maximum therapeutic effects with low side effects. Set-up of the device usually takes several months. Typical side effects include wound infection, temporary salivation, coughing, paralysis of the vocal cords, bradycardia, or even asystole. The patient can stop the VNS by placing a magnet over the generator. The current protocol describes delivery of the specific stimulation tool and methods for adjusting the tuning parameters to achieve the best remission rates in patients with TRD.

Effectiveness of Psychotherapy in Adult ADHD: What Do Patients Think? Results of the COMPAS Study.

OBJECTIVE: In the multicenter study Comparison of Methylphenidate and Psychotherapy in Adult ADHD (COMPAS), the efficacy of treatments has been primarily evaluated by observer-rated symptom change. Here, we additionally analyzed the patients' subjective evaluation of therapy effects. METHOD: COMPAS compared ADHD-specific group therapy with unspecific clinical management with/without concomitant pharmacotherapy in a four-armed design. Evaluation through the patients' retrospective perspective was performed after 1 year (post-treatment) and after another 1.5 years (follow-up). RESULTS: In respect to patients' subjective ratings, ADHD-specific group psychotherapy outperformed unspecific management post-treatment ( z = 4.88, p < .0001) and at follow-up ( z = 2.90, p = .004). Rank correlations with rater-based symptom change were small to moderate (post-treatment: rs = 0.28, follow-up: rs = 0.16). CONCLUSION: Therapy evaluation based on the patients' perspective supports the concept of ADHD-specific group psychotherapy as a potentially useful therapy option in ADHD.

Effects of nature-based mindfulness training on resilience/symptom load in professionals with high work-related stress-levels: findings from the WIN-Study.

PURPOSE: The levels of work-related stress and the incidence rates of subsequent related illnesses are increasing in our society, leading to high individual and socioeconomic burdens. Mindfulness training has been shown to be an effective method of improving stress resilience. This paper aims to investigate the efficacy of nature-based mindfulness training in professionals with high levels of work-related stress. DESIGN/METHODOLOGY/APPROACH: In this controlled pilot study, a total of 56 volunteers completed a nature-based mindfulness training progam and were compared to 8 participants (waitlist controls). Psychometric assessments were performed at baseline and after two and four months of training. FINDINGS: After two months of training, the scores for self-efficacy, sense of coherence, level of mindfulness and overall psychiatric symptom load had significantly improved in the intervention group, while the control group did not show any significant improvements. A comparison between the intervention and control groups showed a significant difference regarding the sense of coherence only. RESEARCH LIMITATIONS/IMPLICATIONS: Since this was an exploratory study with a small control group, further studies are needed to verify our findings. PRACTICAL IMPLICATIONS: In conclusion, nature-based mindfulness training seems to be a promising tool for the improvement of resilience and overall psychological health in professionals. ORIGINALITY/VALUE: This was the first study to systematically investigate effects of nature-based mindfulness training in people with high work-related stress.

Vagus Nerve Stimulation (VNS) and Other Augmentation Strategies for Therapy-Resistant Depression (TRD): Review of the Evidence and Clinical Advice for Use.

In addition to electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), vagus nerve stimulation (VNS) is one of the approved neurostimulation tools for treatment of major depression. VNS is particularly used in therapy-resistant depression (TRD) and exhibits antidepressive and augmentative effects. In long-term treatment, up to two-thirds of patients respond. This mini-review provides a comprehensive overview of augmentation pharmacotherapy and neurostimulation-based treatment strategies, with a special focus on VNS in TRD, and provides practical clinical advice for how to select TRD patients for add-on neurostimulation treatment strategies.

Off-label prescription of psychiatric drugs by non-psychiatrist physicians in three general hospitals in Germany.

BACKGROUND: Off-label prescribing of psychoactive drugs is a common practice in psychiatry. Here, we sought to investigate the frequency of off-label prescribing in a population of hospitalized patients with a somatic illness who were also suffering from a psychiatric pathology. METHODS: Using a prospective, observational design, we collected data from 982 hospitalized patients with a somatic illness for whom a psychiatric consultation was requested because of the presence of additional psychiatric symptoms. Data were collected at three hospitals in Germany. Demographic and clinical data, including the previous psychoactive medications and an assessment of the suitability of the previous medications, were recorded and analyzed. RESULTS: Data on the previous psychiatric medications were available for 972 patients. In 16.6% of patients, at least one psychoactive drug had been prescribed off-label, 20.2% had received on-label medication, and 63.2% had not received any psychiatric medication. Among all patients receiving psychiatric medication, 45.1% had received off-label medication. The logistic regression analysis showed a significant influence of age on the likelihood of receiving off-label medication (p = 0.018). Benzodiazepines were the most frequent off-label prescription (25.8% of off-label prescriptions), followed by atypical antipsychotics (18.2%) and low-potency antipsychotics (17.2%). Notably, 57.1% of off-label prescriptions were judged to be 'not indicated' by experienced psychiatrists. CONCLUSIONS: Our data show a high frequency of the off-label prescription of psychoactive drugs by physicians treating patients with somatic illnesses in general hospitals. Because more than half of these cases were judged to be "not indicated", these prescriptions indicate a potential risk to patients. Furthermore, the classes of drugs that were most frequently prescribed off-label, benzodiazepines and antipsychotics, both show a substantial risk profile, particularly for elderly patients.

Human Parvovirus B19 (B19V) Up-regulates CXCR4 Surface Expression of Circulating Angiogenic Cells: Implications for Cardiac Ischemia in B19V Cardiomyopathy.

Background: Human parvovirus B19 (B19V) infection and damage of circulating angiogenic cells (CAC) results in dysfunctional endogenous vascular repair (DEVR) with secondary end-organ damage. Trafficking of CAC is regulated by SDF-1α and the respective receptor CXCR4. We thus tested the hypothesis of a deregulated CXCR4/SDF-1α axis in symptomatic B19V-cardiomyopathy. Methods: CAC were infected in vitro with B19V and transfected with B19V-components. Read-out were: CXCR4-expression and migratory capacity at increasing doses of SDF-1α. In 31 patients with chronic B19V-cardiomyopathy compared to 20 controls read-outs were from blood: migratory capacity, CXCR4 expression on CAC, serum SDF-1α; from cardiac biopsies: SDF-1α mRNA, HIF-1α mRNA, microvascular density, resident cardiac stem cells (CSC), transcardiac gradients of CAC. Results: In vitro B19V-infected CAC showed up-regulation of surface CXCR4 with increased migratory capacity further enhanced by elevated SDF-1α concentrations. Overexpression of the B19V capsid protein VP2 was associated with this effect. Chronic B19V-cardiomyopathy patients showed increased numbers of ischaemia mobilised CAC but DEVR as well as diminished numbers of CAC after transcardiac passage. Cardiac microvascular density and CSC were significantly reduced in B19V-cardiomyopathy. Conclusions: We thus conclude that B19V infection has a direct VP2-mediated negative impact on trafficking of CAC in the presence of impaired cardiac regeneration.