Study protocol of a randomized controlled trial evaluating home treatment with peer support for acute mental health crises (HoPe).

BACKGROUND: Home treatment (HT) is a treatment modality for patients with severe mental illness (SMI) in acute mental crises. It is frequently considered equivalent to psychiatric inpatient treatment in terms of treatment outcome. Peer Support (PS) means that people with lived experience of a mental illness are trained to support others on their way towards recovery. While PS is growing in international importance and despite a growing number of studies supporting its benefits, it is still not comprehensively implemented into routine care. The HoPe (Home Treatment with Peer Support) study investigates a combination of both - HT and PS - to provide further evidence for a recovery-oriented treatment of psychiatric patients. METHODS: In our randomized controlled trial (RCT), HT with PS is compared with HT without PS within a network of eight psychiatric clinical centers from the North, South and East of Germany. We investigate the effects of a combination of both approaches with respect to the prevention of relapse/recurrence defined as first hospitalization after randomization (primary outcome), disease severity, general functioning, self-efficacy, psychosocial health, stigma resistance, recovery support, and service satisfaction (secondary outcomes). A sample of 286 patients will be assessed at baseline after admission to HT care (data point t0) and randomized into the intervention (HT + PS) and control arm (HT). Follow-Up assessments will be conducted 2, 6 and 12 months after admission (resulting in three further data points, t1 to t3) and will be analyzed via intention-to-treat approach. DISCUSSION: This study may determine the positive effects of PS added to HT, prove additional evidence for the efficacy of PS and thereby facilitate its further implementation into psychiatric settings. The aim is to improve quality of mental health care and patients' recovery as well as to reduce the risk of relapses and hospitalizations for patients with SMI. TRIAL REGISTRATION: The trial is registered with ClinicalTrials.gov: NCT04336527 , April 7, 2020.

Management of intra-thoracic anastomotic leakages after esophagectomy: updated systematic review and meta-analysis of endoscopic vacuum therapy versus stenting.

Despite a significant decrease of surgery-related mortality and morbidity, anastomotic leakage still occurs in a significant number of patients after esophagectomy. The two main endoscopic treatments in case of anastomotic leakage are self-expanding metal stents (SEMS) and the endoscopic vacuum therapy (EVT). It is still under debate, if one method is superior to the other. Therefore, we performed a systematic review and meta-analysis of the existing literature to compare the effectiveness and the related morbidity of SEMS and EVT in the treatment of esophageal leakage. We systematically searched for studies comparing SEMS and EVT to treat anastomotic leak after esophageal surgery. Predefined endpoints including outcome, treatment success, endoscopy, treatment duration, re-operation rate, intensive care and hospitalization time, stricture rate, morbidity and mortality were assessed and included in the meta-analysis. Seven retrospective studies including 338 patients matched the inclusion criteria. Compared to stenting, EVT was significantly associated with higher healing (OR 2.47, 95% CI [1.30 to 4.73]), higher number of endoscopic changes (pooled median difference of 3.57 (95% CI [2.24 to 4.90]), shorter duration of treatment (pooled median difference - 11.57 days; 95% CI [- 17.45 to - 5.69]), and stricture rate (OR 0.22, 95% CI [0.08 to 0.62]). Hospitalization and intensive care unit duration, in-hospital mortality rate, rate of major and treatment related complications, of surgical revisions and of esophago-tracheal fistula failed to show significant differences between the two groups. Our analysis indicates a high potential for EVT, but because of the retrospective design of the included studies with potential biases, these results must be interpreted with caution. More robust prospective randomized trials should further investigate the potential of the two procedures.

The impact of ultra-high-density mapping on long-term outcome after catheter ablation of ventricular tachycardia.

Ultra-high-density (UHD) mapping can improve scar area detection and fast activation mapping in patients undergoing catheter ablation of ventricular tachycardia (VT). The aim of the present study was to compare the outcome after VT ablation guided by UHD and conventional point-by-point 3D-mapping. The acute and long-term ablation outcome of 61 consecutive patients with UHD mapping (64-electrode mini-basket catheter) was compared to 61 consecutive patients with conventional point-by-point 3D-mapping using a 3.5 mm tip catheter. Patients, whose ablation was guided by UHD mapping had an improved 24-months outcome in comparison to patients with conventional mapping (cumulative incidence estimate of the combination of recurrence or disease-related death of 52.4% (95% confidence interval (CI) [36.9-65.7]; recurrence: n = 25; disease-related death: n = 4) versus 69.6% (95% CI [55.9-79.8]); recurrence: n = 31; disease-related death n = 11). In a cause-specific Cox proportional hazards model, UHD mapping (hazard ratio (HR) 0.623; 95% CI [0.390-0.995]; P = 0.048) and left ventricular ejection fraction > 30% (HR 0.485; 95% CI [0.290-0.813]; P = 0.006) were independently associated with lower rates of recurrence or disease-related death. Other procedural parameters were similar in both groups. In conclusion, UHD mapping during VT ablation was associated with fewer VT recurrences or disease-related deaths during long-term follow-up in comparison to conventional point-by-point mapping. Complication rates and other procedural parameters were similar in both groups.

Clinical Implementation and Evaluation of Three Implementation Interventions for a Family-Oriented Care for Children of Mentally Ill Parents (ci-chimps): Study Protocol for a Randomized Controlled Multicenter Trial.

Background: In Germany, approximately three million children under the age of eighteen have a mentally ill parent. These children are at an increased risk of developing a mental illness themselves (1) as well as a physical illness (2). While research has identified numerous evidence-based family-oriented interventions, little is known about how to implement such interventions effectively and efficiently in clinical practice in Germany. This implementation study (ci-chimps) evaluates three clinical implementation projects with three different implementation interventions for the optimal implementation of the tailored family-oriented preventive and therapeutic interventions in the CHIMPS-NET (children of mentally ill parents-research network) with an implementation model for children of mentally ill parents. Methods: A two-group randomized controlled multicenter trial will examine changes in family-oriented practice and aspects of implementation at baseline as well as at 12- and 24-months follow-up. The CHIMPS-Network consists of 20 clinical centers. The centers in the intervention group receive the support of all of the three implementation interventions: (1) optimal pathways to care, (2) education and a training program for professionals, and (3) systematic screening for children. The centers in the control group do not receive this specific implementation support. Discussion: While we know that children of mentally ill parents are an important target group to be addressed by preventive and therapeutic interventions, there is often a lack of structured implementation of family-oriented interventions in clinical practice in Germany. Using a randomized controlled multicenter trial design with a large and wide-ranging sample (clinics for adult psychiatry and clinics for child and adolescent psychiatry, university clinics and clinics at the real health care) will provide a robust understanding of implementing family-oriented changes in German clinical practice. Trial Registration: The CHIMPS-NET-study was registered with the German Clinical Trials Register on 2019-12-19 (DRKS00020380) and with Clinical Trials on 2020-4-30 (NCT04369625), the ci-chimps-study was registered with the German Clinical Trials Register (DRKS00026217) on 2021-08-27, the Clinical Trials registration is in review process.

Clinical- and Cost Effectiveness of a Guided Internet-Based Intervention for Children (12-18 Years) of Parents With Mental Disorders (iCHIMPS): Study Protocol of a Multicentered Cluster-Randomized Controlled Trial.

INTRODUCTION: Children of parents with mental disorders have a high chance of developing a mental disorder themselves. However, this at-risk group is regularly overlooked and typically not seen by any mental health professionals. Internet- and mobile-based interventions (IMIs) can provide a means of promoting mental health for children of parents with mental disorders. OBJECTIVE: The introduced study will evaluate the clinical- and cost-effectiveness of the iCHIMPS IMI in promoting mental health for children of parents with mental disorders. METHODS: A two-armed multicentered cluster-randomized controlled trial (cRCT) comparing the clinical- and cost-effectiveness of the iCHIMPS IMI in the intervention group (IG) to a treatment-as-usual (TAU) control group will be conducted. Recruitment will be handled at currently 21 adult mental health clinics throughout Germany. Participating families will be randomly divided into the two groups until the final sample size of 306 participating adolescents (age 12-18) has been reached. The adolescents in the intervention group will receive access to the IMI and can take part in up to eight intervention modules. Assessment will be conducted during the recruitment (baseline), 1-month, 2-months, and 6-month post-inclusion. Primary outcome is the mental health of the participating adolescents at 6-months post-inclusion as measured by the Youth Self Report score. Secondary self-report outcomes are mental wellbeing, self-efficacy, coping strategies and negative effects as well as mental health of the adolescents as reported by their parent(s). Included moderators are sociodemographic characteristics, working alliance, social support and the mental health diagnoses of the parents. Statistical analyses will be conducted on the intention-to-treat principle as well as with additional per-protocol analyses. Additionally, the cost-effectiveness as well as qualitative data concerning the adherence, acceptance, and feasibility of the IMI will be analyzed. DISCUSSION: The iCHIMPS cRCT examines the clinical- as well as cost-effectiveness of the iCHIMPS mental health promotion IMI for children of parents with mental disorders. This provides the opportunity to gain insights into an innovative as well as time- and location-independent form of support for this often-overlooked at-risk group. Additionally, the larger CHIMPS-NET project allows comparisons between internet-based and face-to-face interventions for a similar target group. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, identifier: DRKS00025158.

Refining M1 stage in medulloblastoma: criteria for cerebrospinal fluid cytology and implications for improved risk stratification from the HIT-2000 trial.

BACKGROUND: Medulloblastoma is the most common malignant paediatric brain tumour, and cerebrospinal fluid (CSF) dissemination (M1 stage) is a high-risk prognostic factor. Criteria for CSF evaluation and for differentiating M0 from M1 stage are not clearly defined, and the prognostic significance of M1 stage in this context is unknown. PATIENTS AND METHODS: CSF investigations from 405 patients with medulloblastoma of the prospective multicenter trial HIT-2000 (HIirnTumor-2000) were reviewed. Data from 213 patients aged ≥4 years were related to 5-year progression-free (5y-PFS) and overall survival. RESULTS: Patients with cytological tumour dissemination only (M1 stage only) aged ≥4 years (n = 18) and patients with radiologically detected metastases (M2/3, n = 85) showed a worse 5y-PFS than M0 patients (n = 110) without signs of metastatic disease (5y-PFS 61.1% and 59.6% vs 80.7%; p < 0.02 and p < 0.01, log rank). Patients with positive samples drawn early after surgery who turned negative within 14 days postoperatively (n = 9) and patients with atypical cells (n = 6) showed a 5y-PFS similar to M0 patients. No tumour cells were detected in samples containing <10 nucleated cells. Analysis of cytological criteria showed a better predictive value for tumour cell clusters than ≥2 individual tumour cells. CONCLUSION: Based on our results, we suggest that CSF medulloblastoma staging should be performed 14 days postoperatively by lumbar puncture, and specimens should contain at least 10 nucleated cells. Cytological tumour dissemination alone (M1 stage only) appears a high-risk prognostic factor associated with an outcome comparable to M2/M3 stage. Tumour cell clusters seem to have a greater impact on prognosis than single tumour cells. This should be validated further.

Specific electrogram characteristics impact substrate ablation target area in patients with scar-related ventricular tachycardia-insights from automated ultrahigh-density mapping.

INTRODUCTION: Substrate-based catheter ablation approaches to ventricular tachycardia (VT) focus on low-voltage areas and abnormal electrograms. However, specific electrogram characteristics in sinus rhythm are not clearly defined and can be subject to variable interpretation. We analyzed the potential ablation target size using automatic abnormal electrogram detection and studied findings during substrate mapping in the VT isthmus area. METHODS AND RESULTS: Electrogram characteristics in 61 patients undergoing scar-related VT ablation using ultrahigh-density 3D-mapping with a 64-electrode mini-basket catheter were analyzed retrospectively. Forty-four complete substrate maps with a mean number of 10319 ± 889 points were acquired. Fractionated potentials detected by automated annotation and manual review were present in 43 ± 21% of the entire low-voltage area (<1.0 mV), highly fractionated potentials in 7 ± 8%, late potentials in 13 ± 15%, fractionated late potentials in 7 ± 9% and isolated late potentials in 2 ± 4%, respectively. Highly fractionated potentials (>10 ± 1 fractionations) were found in all isthmus areas of identified VT during substrate mapping, while isolated late potentials were distant from the critical isthmus area in 29%. CONCLUSION: The ablation target area varies enormously in size, depending on the definition of abnormal electrograms. Clear linking of abnormal electrograms with critical VT isthmus areas during substrate mapping remains difficult due to a lack of specificity rather than sensitivity. However, highly fractionated, low-voltage electrograms were found to be present in all critical VT isthmus sites.

Posterior fusion of the craniocervical junction in the pediatric spine: Wright's translaminar C2 screw technique provides for more safety and effectiveness.

PURPOSE: Posterior fusion of the craniocervical junction (CCJ) has always been challenging in children with rare congenital diseases and malformations. At our institution, the introduction of the translaminar C2 screw technique led to a significant improvement in the quality of treatment. METHODS: Retrospective analysis of a pediatric cohort at a single institution who underwent CCJ posterior fusion between 2007 and 2018. Patients were divided into group 1 (other posterior fusion techniques, n = 12) and group 2 (translaminar axis screw placement, n = 19). Diagnosis, sex, age at surgery, surgical technique, immobilization, revisions, fusion, reduction, and complications were assessed. RESULTS: Follow-up ranged from 12 to 145 months (mean 50.7). The initial fusion rate detected at 3 months by CT differed significantly (66, 7% in group 1 vs. 100% in group 2, p = 0.018). Full reduction of C1/C2 malalignments was achieved in 41, 6% of group 1 versus 84, 2% of group 2 (p = 0.007). Immobilization was applied in 83, 3% of group 1 versus 26, 3% of group 2 (p = 0.0032). Ten complications were treated conservatively, and 15 events required revision surgery (80% in group 1 vs. 20% in group 2). Eight complications were related to immobilization. CONCLUSIONS: The implementation of the translaminar C2 technique resulted in significantly more safety and efficiency regarding pediatric posterior fusion CCJ surgery at our institution, with significantly higher rates of rigid fixation, full reduction, and fusion, and significantly lower rates of complications and immobilization. These slides can be retrieved under Electronic Supplementary Material.