Development and evaluation of an internet- and mobile-based intervention for individualized return to work planning after inpatient rehabilitation - Study protocol for a randomized-controlled-trial.

Background: Following discharge, it is crucial for patients to transfer intentions and action plans from inpatient rehabilitation into everyday life. This ensures their reintegration into social and working life and prevents economic costs due to sick leave or reduced earning capacity pension. However, most established aftercare programs do not specifically address occupational problems or challenges during occupational measures such as graded return to work. The aim of this study is to evaluate the efficacy of the low-threshold online self-help intervention marena (Meine Arbeitsbezogene Reha-Nachsorge - My Work-related Rehabilitation Aftercare) to support return to work. Methods: A two-arm randomized-controlled-trial (RCT) will be conducted. A total of N = 400 rehabilitation inpatients across different indication areas (psychosomatic, orthopedic, or cardiologic) aged 18 to 65 years with a planned return to work after medical rehabilitation, have a heightened social-medical risk and private internet access and are insured with the German Pension insurance or statutory health insurance, will be recruited in four medical and psychosomatic clinics in Germany. Participants will be allocated to either the intervention (IG) or the control group (CG). In a stepped-care model, participants of the IG will receive access to the non-guided internet- and mobile-based intervention marena (IG subgroup 1) or marena in combination with GSA-Online plus (IG subgroup 2), a guided psychodynamic internet-based intervention that has proven effective in two trials regarding occupational and health objectives. Based on a priori defined indication criteria, clinic staff will recommend either IG subgroup 1 or IG subgroup 2. The CG will receive optimized treatment as usual with access to a survey feature within marena. The primary outcome will be work status after 6 months (T2) and 12 months (T4). The endpoint at 12 months (T4) after discharge from inpatient rehabilitation will be considered as secondary endpoint. Work status is defined as positive if the participant is working and has ≤ 6 weeks of sick leave at T2 and ≤ 12 weeks of sick leave at T4. Secondary outcomes include successful completion of graded return to work, successful application for benefits for participation in working life, current work ability, social-medical risk, subjective prognosis of future employment, quality of life, somatic symptoms, coping, social support, depression, anxiety, and psychosocial stress. Discussion: This study will contribute to the evidence concerning efficacy of online aftercare interventions. If proven efficacious, marena could provide an individualized and adaptable self-help approach to promote return to work following inpatient rehabilitation.

Gender-Specific Performance of One- Compared to Two-Catheter Concepts in Transradial Coronary Angiography - Insights From the Randomized UDDC-Radial-Trial.

OBJECTIVES: The present sub-analysis from the randomized UDDC-Radial-Trial sought to compare one-catheter concepts (OCC) with two-catheter concepts (TCC) in different patient subgroups, particularly in those depending on gender and age. BACKGROUND: There is an ongoing debate regarding potential performance differences of OCC compared to TCC for transradial coronary angiography in specific patient subgroups. METHODS: The randomized UDDC-Radial-Trial enrolled a total of 300 patients planed for coronary angiography in a 2:1 ratio to either OCC by Tiger II (n = 100) and BLK (n = 100) or TCC by Judkins (n = 100) catheters. Predefined patient subgroups stratified for age, gender and patient constitution were analyzed with regard to the primary outcome measure of time required for a complete coronary angiography. RESULTS: In male patients time for coronary angiography was significantly shorter in the TCC group compared to the OCC group (510 ± 37 s vs. 615 ± 35 s; p = 0.046). No difference between the catheter concepts was observed in the subset of female patients (525 ± 34 s vs. 583 ± 54 s; p = 0.43). TCC was associated with shorter coronary angiography time in patients aged <71 years compared to OCC (462 ± 23 s vs. 570 ± 38 s; p = 0.018). In patients ≥72 years of age no difference was detected (573 ± 41 s vs. 636 ± 45 s; p = 0.31). Other subgroups showed no relevant differences in angiography time among OCC and TCC. CONCLUSIONS: The present subgroup analysis from the UDDC-radial trial demonstrates the use of OCC in transradial diagnostic angiography to be inferior compared to TCC in terms of angiography time in younger and male patients.

Diagnostic Accuracy of High-Sensitive Troponin for the Identification of Myocardial Infarction in Patients Presenting with Acute Heart Failure.

BACKGROUND: The differentiation of myocardial infarction (MI) in the setting of acute heart failure (AHF) can be challenging because the majority of patients presenting with AHF show elevations of high-sensitive troponin (hs-Tn). Fast identification of MI is crucial to perform timely coronary angiography and to improve clinical outcome. OBJECTIVES: The aim of the present study was to assess the diagnostic accuracy of different levels of hs-Tn for the identification of type 1 MI in patients with AHF. METHODS: This was a retrospective single-center analysis of admitted AHF patients with documentation of high-sensitive troponin T (hs-TnT). RESULTS: A total of 649 patients were enrolled into the present study. Of them, 18% had type 1 MI, 7% had type 2 MI, 69% had myocardial injury, and 6% had no myocardial injury. The area under the curve of hs-TnT for the prediction of type 1 MI was 0.70. Sensitivity and specificity of the hs-TnT 99th percentile upper reference limit (URL) for type 1 MI was 100% and 8%, respectively. The Youden index derived cut-off of hs-TnT was 50 ng/L, showing a sensitivity and specificity for type 1 MI of 63% and 68%, respectively. No significant difference regarding 30-day mortality was found depending on the presence of type 1 MI (odds ratio 1.86; 95% confidence interval 0.91-3.81). CONCLUSIONS: Hs-TnT-based identification of type 1 MI in patients with AHF requires higher cut-offs compared with the 99th percentile URL used in overall acute coronary syndrome populations. However, the adjusted cut-off provided only moderate sensitivity and specificity.

Prognostic impact of high-sensitive troponin on 30-day mortality in patients with acute heart failure and different classes of left ventricular ejection fraction.

High-sensitive troponin T (hs-TnT) is increasingly used for prognostication in patients with acute heart failure (AHF). However, uncertainty exists whether hs-TnT shows comparable prognostic performance in patients with heart failure and different classes of left ventricular ejection fraction (LV-EF). The aim of the present study was to assess the prognostic value of hs-TnT for the prediction of 30-day mortality depending on the presence of HF with preserved ejection fraction (HFpEF), HF with mid-range LV-EF (HFmrEF) and HF with reduced LV-EF (HFrEF) in patients with acutely decompensated HF. Patients admitted to our institution due to AHF were retrospectively included. Clinical information was gathered from electronic and paper-based patient charts. Patients with myocardial infarction were excluded. A total of 847 patients were enrolled into the present study. A significant association was found between HF groups and hs-TnT (regression coefficient -0.018 for HFpEF vs. HFmrEF/HFrEF; p = 0.02). The area under the curve (AUC) of hs-TnT for the prediction of 30-mortality was significantly lower in patients with HFpEF (AUC 0.61) than those with HFmrEF (AUC 0.80; p = 0.01) and HFrEF (AUC 0.73; p = 0.04). Hs-TnT was not independently associated with 30-day outcome in the HFpEF group (OR 1.48 [95%-CI 0.89-2.46]; p = 0.13) in contrast to the HFmrEF group (OR 4.53 [95%-CI 1.85-11.1]; p < 0.001) and HFrEF group (OR 2.58 [95%-CI 1.57-4.23]; p < 0.001). Prognostic accuracy of hs-TnT in patients hospitalized for AHF regarding 30-day mortality is significantly lower in patients with HFpEF compared to those with HFmrEF and HFrEF.

Accuracy of high-sensitive troponin depending on renal function for clinical outcome prediction in patients with acute heart failure.

High-sensitive troponin T (hs-TnT) is increasingly used for clinical outcome prediction in patients with acute heart failure (AHF). However, there is an ongoing debate regarding the potential impact of renal function on the prognostic accuracy of hs-TnT in this setting. The aim of the present study was to assess the prognostic value of hs-TnT within 6 h of admission for the prediction of 30-day mortality depending on renal function in patients with AHF. Patients admitted to our institution due to AHF were retrospectively included. Clinical information was gathered from electronic and paper-based patient charts. Patients with myocardial infarction were excluded. A total of 971 patients were enrolled in the present study. A negative correlation between estimated glomerular filtration rate (eGFR) and hsTnT was identified (Pearson r = - 0.16; p < 0.001) and eGFR was the only variable to be independently associated with hsTnT. The area under the curve (AUC) of hs-TnT for the prediction of 30-mortality was significantly higher in patients with an eGFR ≥ 45 ml/min (AUC 0.74) compared to those with an eGFR < 45 ml/min (AUC 0.63; p = 0.049). Sensitivity and specificity of the Youden Index derived optimal cut-off for hs-TnT was higher in patients with an eGFR ≥ 45 ml/min (40 ng/l: sensitivity 73%, specificity 71%) compared to patients with an eGFR < 45 ml/min (55 ng/l: sensitivity 63%, specificity 62%). Prognostic accuracy of hs-TnT in patients hospitalized for AHF regarding 30-day mortality is significantly lower in patients with reduced renal function.

Impact of real-time angiographic co-registered optical coherence tomography on percutaneous coronary intervention: the OPTICO-integration II trial.

AIMS: Longitudinal geographic mismatch (LGM) as well as edge dissections are associated with an increased risk of adverse events after percutaneous coronary intervention (PCI). Recently, a novel system of real-time optical coherence tomography (OCT) with angiographic co-registration (ACR) became available and allows matched integration of cross-sectional OCT images to angiography. The OPTICO-integration II trial sought to assess the impact of ACR for PCI planning on the risk of LGM and edge dissections. METHODS: A total of 84 patients were prospectively randomized to ACR-guided PCI, OCT-guided PCI (without co-registration), and angiography-guided PCI. Primary endpoint was a composite of major edge dissection and/or LGM as assessed by post-PCI OCT. RESULTS: The primary endpoint was significantly reduced in ACR-guided PCI (4.2%) as compared to OCT-guided PCI (19.1%; p = 0.03) and angiography-guided PCI (25.5%; p < 0.01). Rates of LGM were 4.2%, 17.0%, and 22.9% in the ACR-guided PCI, in the OCT-guided PCI, and the angiography-guided PCI groups, respectively (ACR vs. OCT p = 0.04; ACR vs. angiography p = 0.04). The number of major edge dissections was low and without significant differences among the study groups (0% vs. 2.1% vs. 4.3%). CONCLUSION: This study for the first time demonstrates superiority of ACR-guided PCI over OCT- and angiography-guided PCI in reducing the composite endpoint of major edge dissection and LGM, which was meanly driven by a reduction of LGM.

Endovascular therapy of subclavian artery occlusive disease involving the vertebral artery origin.

Background: While the majority of subclavian artery (SA) lesions are localized in the proximal segment, the evidence in patients with medial SA disease involving the vertebral artery (VA) origin are scarce. PATIENTS AND METHODS: We retrospectively analyzed all patients who underwent percutaneous revascularization of the SA at our institution. RESULTS: A total of 196 patients were retrospectively analyzed. The majority of SA lesions (n = 163, 83 %) were located in the proximal segment, whereas 28 lesions (14 %) were located in the medial segment, and only 5 lesions (3 %) involved the distal segment. Procedural success was high for both stenosis (96 %) and occlusion (89 %) and did not differ depending on lesion location. Revascularization techniques in the medial segment included stenting of the SA only (13 patients), additional VA balloon-dilatation (6 patients), and bifurcation stenting of the SA and VA using T-stenting technique (9 patients). Outcome after a median of 12 months showed no significant differences in freedom from restenosis between proximal and medial lesions (90 % vs. 95 %; p = 0.67). CONCLUSIONS: Endovascular revascularization of SA disease with medial segments involving the VA origin required more complex techniques and showed long-term patency rates comparable to those in lesions located within the proximal SA.

Performance of One- Compared With Two-Catheter Concepts in Transradial Coronary Angiography (from the Randomized Use of Different Diagnostic Catheters-Radial-Trial).

The Use of Different Diagnostic Catheters-Radial-Trial sought to compare the safety and efficacy of one-catheter concepts (OCC) using Tiger II or BLK catheters with two-catheter concepts (TCC) using standard Judkins catheters for transradial coronary angiography. A total of 300 patients planed for coronary angiography were enrolled into this single-center, single-blinded trial. Patients were randomized in a 2:1 ratio to either OCC by Tiger II (n = 100) and BLK (n = 100) or TCC by Judkins (n = 100) catheters. Primary end point was time required to perform a complete coronary angiography. Coronary angiography duration was 603 ± 29 seconds and 552 ± 26 sec in the OCC and the TCC groups (p = 0.052). Fluoroscopy time was longer in the OCC (408 ± 28 sec) as compared with the TCC group (258 ± 28 sec, p = 0.009) and the amount of contrast volume used significantly higher (98 ± 5 ml vs 67 ± 4 ml, p < 0.001). Crossover rates were increased in the OCC as compared with the TCC group (37% vs 4%, p < 0.001). These effects were observed irrespective of OCC catheter type. In conclusion, this study demonstrates that OCC do not reduce angiography time, but are associated with an increased amount of contrast volume and longer fluoroscopy time as compared with TCC.

Transcript and metabolite profiling for the evaluation of tobacco tree and poplar as feedstock for the bio-based industry.

The global demand for food, feed, energy and water poses extraordinary challenges for future generations. It is evident that robust platforms for the exploration of renewable resources are necessary to overcome these challenges. Within the multinational framework MultiBioPro we are developing biorefinery pipelines to maximize the use of plant biomass. More specifically, we use poplar and tobacco tree (Nicotiana glauca) as target crop species for improving saccharification, isoprenoid, long chain hydrocarbon contents, fiber quality, and suberin and lignin contents. The methods used to obtain these outputs include GC-MS, LC-MS and RNA sequencing platforms. The metabolite pipelines are well established tools to generate these types of data, but also have the limitations in that only well characterized metabolites can be used. The deep sequencing will allow us to include all transcripts present during the developmental stages of the tobacco tree leaf, but has to be mapped back to the sequence of Nicotiana tabacum. With these set-ups, we aim at a basic understanding for underlying processes and at establishing an industrial framework to exploit the outcomes. In a more long term perspective, we believe that data generated here will provide means for a sustainable biorefinery process using poplar and tobacco tree as raw material. To date the basal level of metabolites in the samples have been analyzed and the protocols utilized are provided in this article.

Enlarged substantia nigra hyperechogenicity and risk for Parkinson disease: a 37-month 3-center study of 1847 older persons.

OBJECTIVE: To evaluate whether enlarged substantia nigra hyperechogenicity (SN+) is associated with an increased risk for Parkinson disease (PD) in a healthy elderly population. DESIGN: Longitudinal 3-center observational study with 37 months of prospective follow-up. SETTING: Individuals 50 years or older without evidence of PD or any other neurodegenerative disease. PARTICIPANTS: Of 1847 participants who underwent a full medical history, neurological assessment, and transcranial sonography at baseline, 1535 could undergo reassessment. MAIN OUTCOME MEASURE: Incidence of new-onset PD in relation to baseline transcranial sonography status. RESULTS: There were 11 cases of incident PD during the follow-up period. In participants with SN+ at baseline, the relative risk for incident PD was 17.37 (95% confidence interval, 3.71-81.34) times higher compared with normoechogenic participants. CONCLUSIONS: In this prospective study, we demonstrate for the first time a highly increased risk for PD in elderly individuals with SN+. Transcranial sonography of the midbrain may therefore be a promising primary screening procedure to define a risk population for imminent PD.

Width of the third ventricle assessed by transcranial sonography can monitor brain atrophy in a time- and cost-effective manner--results from a longitudinal study on 500 subjects.

Ventricular width and its enlargement over time are discussed as promising markers for preclinical brain atrophy. The aim of our study was to define whether brain atrophy can reliably be monitored by transcranial ultrasound (TCS). In a prospective longitudinal trial over 5years, 500 healthy persons were examined by a standardized protocol with TCS in addition to an extensive cognitive testing using the Consortium to Establish a Registry of Alzheimer's Disease - Neuropsychological Testing (CERAD-NP). TCS displayed the third ventricle in 96% of all cases at the follow-up with a high intra-individual reproducibility and excellent inter-rater coefficient (0.992). The mean diameter of the third ventricle in subjects with a cognitive decline was significantly wider (6mm±2) than in subjects with normal cognitive testing results (4.6mm±1.8). We demonstrated that the width of the third ventricle, as a marker of brain atrophy can reliably be monitored by using TCS as a non-invasive, time- and cost-effective method. We provide evidence that the assessed width of the third ventricle can differentiate between subjects with a normal cognitive performance and subjects with a cognitive decline. TCS may be a useful screening tool in the early diagnosis of cognitive decline.

PET/CT in malignant melanoma: contrast-enhanced CT versus plain low-dose CT.

PURPOSE: The aim of this study was to evaluate the diagnostic value of contrast-enhanced CT (CECT) versus non-enhanced low-dose CT (NECT) in the staging of advanced malignant melanoma with (18)F-fluordeoxyglucose (FDG) positron emission tomography (PET)/CT. METHODS: In total, 50 (18)F-FDG PET/CT examinations were performed in 50 patients with metastasized melanoma. For attenuation correction, whole-body NECT was performed followed by diagnostic CECT with contrast agent. For the whole-body PET, (18)F-FDG was applied. Criteria for evaluation were signs of vital tumour tissue (extent of lesions, contrast enhancement, maximum standardized uptake value >2.5). Findings suspicious for melanoma were considered lesions. NECT, CECT and (18)F-FDG PET were evaluated separately, followed by combined analysis of PET/NECT and PET/CECT. Findings were verified histologically and/or by follow-up (>6 months). RESULTS: Overall, 232 lesions were analysed, and 151 proved to be metastases. The sensitivity of NECT, CECT, PET, PET/NECT and PET/CECT was 62, 85, 90, 97 and 100%, and specificity was 52, 63, 88, 93 and 93%, respectively. Compared to CECT, NECT obtained additional false-negative results: lymph node (n = 19) and liver/spleen metastases (n = 9). Misinterpreted physiological structures mainly caused additional false-positive findings (n = 17). In combined analysis of PET/NECT, six false-positive [other tumours (n = 2), inflammatory lymph nodes (n = 2), inflammatory lung lesion (n = 1), blood vessel (n = 1)] and five false-negative findings [liver (n = 3), spleen (n = 1), lymph node metastases (n = 1)] remained. On PET/CECT, six false-positive [inflammatory lymph nodes (n = 3), other tumours (n = 2), inflammatory lung lesion (n = 1)] and no false-negative findings occurred. However, additional false findings on PET/NECT (6 of 232) did not change staging compared to PET/CECT. CONCLUSION: Our results indicate that it is justified to perform PET/NECT instead of PET/CECT for melanoma staging.

[Psychotherapy within the prison system after the change of law]. / Psychotherapie im Justizvollzug nach der Anderung des Strafvollzugsgesetzes.

The amendment of the law limiting the professional secrecy of physicians and psychologists toward the prison authorities has triggered a discussion on the consequences involved for treatment practice in the prison system. To reduce the lack of empirically based arguments in this discussion, our study deals with the question of whether and to what extent psychotherapy in conjunction with prison health care offers also contributions to preventing recidivism. A quasi-experimental control group study showed that especially for serious violent offenses delinquents of the Tegel detention center who underwent at least 20 hours of therapy at the psychotherapeutic consultation and treatment service had a markedly lower recidivism rate a mean of four years after release from prison than an untreated group. If changes in the penal code jeopardize a regular therapeutic setting with professional secrecy, they carry the risk of excluding prisoners primarily requiring psychotherapy who have thus far apparently also derived benefit especially from prevention-oriented therapy.