The last year of life for patients dying from cancer vs. non-cancer causes: a retrospective cross-sectional survey of bereaved relatives.

PURPOSE: To compare health care experiences of patients with cancer or non-cancer diseases in their last year of life. METHODS: A cross-sectional post-bereavement survey was conducted using an adapted German version of the VOICES questionnaire (VOICES-LYOL-Cologne). Differences in the reported experiences were assessed using a two-sided Pearson's chi-square test and Mann-Whitney U test. RESULTS: We collected data from 351 bereaved relatives. More than half of non-cancer patients were not informed that their disease could lead to death (p < 0.001). When this was communicated, in 46.7% of non-cancer and 64.5% of cancer patients, it was reported by the hospital doctor (p = 0.050). In all, 66.9% of non-cancer and 41.6% of cancer patients were not informed about death being imminent (p < 0.001). On average, non-cancer patients had significantly fewer transitions and hospital stays in their last year of life (p = 0.014; p = 0.008, respectively). Non-cancer patients were treated more often by general practitioners, and cancer patients were treated more often by specialists (p = 0.002; p = 0.002, respectively). A substantially lower proportion of non-cancer patients were treated by at least one member of or in the setting of general or specialized palliative care (p < 0.001). CONCLUSIONS: Non-cancer patients experience disadvantages in communication regarding their care and in access to specialized palliative care in their last year of life compared to cancer patients. Regarding the assessment of palliative care needs and the lack of communication of an incurable disease, non-cancer patients are underserved. An early identification of patients requiring palliative care is a major public health concern and should be addressed irrespective of diagnosis. TRIAL REGISTRATION: Prospectively registered by the German Clinical Trials Register (DRKS00011925, data of registration: 13.06.2017).

Oil pulling to relieve medication-induced xerostomia: A randomized, single-blind, crossover trial.

OBJECTIVES: To determine the subjective effectiveness of oilpulling on medication-induced xerostomia with regard to symptom relief, quality of life, taste, mucosal moisture and oral parameters. MATERIALS AND METHODS: In a randomized, single-blind, crossover trial in participants with medication-induced xerostomia (n = 26; mean age 64.71 (standard deviation (SD) 15.60) years), we investigated oilpulling efficacy (sunflower oil) versus mineral water after one-week use. Xerostomic burden (visual analogue scale, VAS), symptom relief and oral examinations (gingivitis index, plaque index, whole stimulated and unstimulated salivation rates) were investigated at baseline and the end of the follow-up. RESULTS: Oilpulling reduced the xerostomic burden (baseline value 6.46 (SD 1.80), decreasing to 4.93 (SD 2.97)) (p = .003), without difference between oil versus water (p = .067). Baseline values for water were 6.08 (SD 2.17) decreasing to 5.72 (SD 2.17) (p = .124). Compared to water, oil made swallowing easier (p = .031), caused a pleasant mouthfeel (p = .031) and caused less waking up at night (p = .031). Effectiveness (p = .002) and duration (p = .007) of symptom relief showed differences between products in favour of oil. CONCLUSIONS: Oil pulling alleviated the overall xerostomic burden. In the comparison between oil and water, no difference regarding symptom relief could be shown. Patients should be informed of possibilities and limitations of oilpulling as inexpensive and easy-to-obtain alternative to commercially available products for short-term symptom relief.

Influence of motivational placebo-related factors on the effects of exercise treatment in depressive adolescents.

Recent meta-analyses reveal a moderate effect of physical activity (PA) in the treatment of adolescent depression. However, not only the underlying neurobiological mechanisms, also the influences of placebo-related motivational factors (beliefs and expectancies in sporting, enjoyment and prior sports experiences), are still unclear. Based on the data of our prior study "Mood Vibes", we hypothesized that placebo-inherent factors like positive prior sports experiences and motivational factors, (positive beliefs, expectancies, and enjoyment related to PA), would increase the effects of an add-on exercise-therapy in juvenile depression. From 64 included depressed adolescents, 41 underwent an intensive add-on PA-therapy. Motivational factors were assessed using sport-specific scales. The changes in depression scores under treatment were rated by self-rating scale (German "Childhood Depression Inventory", (DIKJ)). A mixed model for repeated measures (MMRM) was used to analyze the effects of the different motivational variates on DIKJ. While prior sports experiences had no impact, motivational factors showed a significant effect on PA-induced changes in DIKJ scores (p = 0.002). The demotivated participants improved less, whereas it was sufficient to be neutral towards sporting to benefit significantly more. Motivational placebo-related factors (beliefs, expectancies and enjoyment regarding PA) affected the outcomes of an exercise treatment in depressed adolescents. Yet, a neutral mindset was sufficient to profit more from PA. Prior sporting in the sense of positive conditioning and as a protective factor did not play a role. Knowledge about these influences could in a second step help to develop tailored therapies.

Evaluation Of CPR Quality Via Smartphone With A Video Livestream - A Study In A Metropolitan Area.

BACKGROUND: Telephone-assisted cardiopulmonary resuscitation (CPR) is an effective and proven tool to improve patient survival and outcome after cardiac arrest, and is therefore recommended in international resuscitation guidelines. A new technology that provides the emergency medical services (EMS) dispatcher with a video livestream from a smartphone during telephone-assisted CPR was investigated to assess whether a correct judgment of CPR quality is feasible. MATERIAL AND METHODS: After Ethics Committee approval, we conducted this study from August to September 2018 in the University Hospital of Cologne and its metropolitan area. Our study team set up a full-scale resuscitation mannequin on 54 study sites. Video telephony between caller and EMS dispatcher was established, and CPR was initiated with randomized common quality issues concerning compression frequency, compression depth, and compression point. It was evaluated whether the dispatcher recognized correct and incorrect resuscitation performance. RESULTS: Forty-six video calls were established successfully. EMS dispatching staff identified correct compression frequency (100-120/min) in 87.5% of the cases, too low frequency (<80/min) was correctly identified in 92%, and too high frequency (>140/min) in 58.5%, respectively. Correct compression depth (5-6 cm) was identified in 70.6%, shallow compressions (<3cm) in 92.9% and a continuous decrease of depth in 100% of all cases. Correct compression point was identified in 87.5%, incorrect epigastric compression in 92.3%, incomplete release in 58.8%. CONCLUSION: A video livestream from a smartphone can support an EMS dispatcher's assistance in resuscitation. Typical resuscitation mistakes, like incorrect compression frequency or depth, and incorrect compression points could be recognized and corrected efficiently via video livestream.

Effectiveness of brushing teeth in patients with reduced oral hygiene by laypeople: a randomized, controlled study.

BACKGROUND: To evaluate the success of plaque reduction after external toothbrushing by instructed laypeople versus dental professionals using either a manual or powered toothbrush. Longitudinal, randomized, parallel-group intervention study in periodontitis patients with reduced oral hygiene quality undergoing anti-infective therapy. Patients were randomly and equally assigned to one of four groups: laypeople using a manual or powered toothbrush or dental professionals using a manual or powered toothbrush. Plaque reduction (Quigley-Hein-Index (QHI), Marginal Plaque Index (MPI)), gingivitis (papilla bleeding index), and cleaning time (seconds) were investigated. RESULTS: Thirty-nine patients participated in the study. Neither the choice of toothbrush (p = 0.399) nor the use of a dental professional (p = 0.790) had a significant influence on plaque levels achieved. However, multivariate modeling indicated statistically significant differences in the external cleaning time between brushing groups, with longer time required by laypeople (p = 0.002) and longer use of the powered toothbrush (p = 0.024). CONCLUSION: When the ability to carry out personal oral hygiene is reduced, external brushing by dental professionals or instructed laypeople who meet previously defined criteria such as sufficient personal oral hygiene at home could help to fill the emerging dental care gap. A combination of oral hygiene approaches adapted to the individual needs of the patients in need of external help is necessary for optimum oral hygiene. TRIAL REGISTRATION: German Clinical Trials register ( https://www.germanctr.de ; number DRKS00018779; date of registration 04/11/2019).

Higher incidence of perivalvular abscess determines perioperative clinical outcome in patients undergoing surgery for prosthetic valve endocarditis.

BACKGROUND: Cardiac surgery for prosthetic valve endocarditis (PVE) is associated with substantial mortality. We aimed to analyze 30-day and 1-year outcome in patients undergoing surgery for PVE and sought to identify preoperative risk factors for mortality with special regard to perivalvular infection. METHODS: We retrospectively analyzed data of 418 patients undergoing valve surgery for infective endocarditis between January 2009 and July 2018. After 1:1 propensity matching 158 patients (79 PVE/79 NVE) were analyzed with regard to postoperative 30-day and 1-year outcomes. Univariate and multivariable analyses were performed to identify potential risk factors for mortality. RESULTS: 315 patients (75.4%) underwent surgery for NVE and 103 (24.6%) for PVE. After propensity matching groups were comparable with regard to preoperative characteristics, clinical presentation and microbiological findings, except a higher incidence of perivalvular infection in patients with PVE (51.9%) compared to NVE (26.6%) (p = 0.001), longer cardiopulmonary bypass (166 [76-130] vs. 97 [71-125] min; p < 0.001) and crossclamp time (95 [71-125] vs. 68 [55-85] min; p < 0.001). Matched patients with PVE showed a 4-fold increased 30-day mortality (20.3%) in comparison with NVE patients (5.1%) (p = 0.004) and 2-fold increased 1-year mortality (PVE 29.1% vs. NVE 13.9%; p = 0.020). Multivariable analysis revealed perivalvular abscess, sepsis, preoperative AKI and PVE as independent risk factors for mortality. Patients with perivalvular abscess had a significantly higher 30-day mortality (17.7%) compared to patients without perivalvular abscess (8.0%) (p = 0.003) and a higher rate of perioperative complications (need for postoperative pacemaker implantation, postoperative cerebrovascular events, postoperative AKI). However, perivalvular abscess did not influence 1-year mortality (20.9% vs. 22.3%; p = 0.806), or long-term complications such as readmission rate or relapse of IE. CONCLUSIONS: Patients undergoing surgery for PVE had a significantly higher 30-day and 1-year mortality compared to NVE. After propensity-matching 30-day mortality was still 4-fold increased in PVE compared to NVE. Patients with perivalvular abscess showed a significantly higher 30-day mortality and perioperative complications, whereas perivalvular abscess seems to have no relevant impact on 1-year mortality, the rate of readmission or relapse of IE.

Length Polymorphisms in the Angiotensin I-Converting Enzyme Gene and the Serotonin-Transporter-Linked Polymorphic Region Constitute a Risk Haplotype for Depression in Patients with Coronary Artery Disease.

Genetic variations affecting the course of depressive symptoms in patients with coronary artery disease (CAD) have not yet been well studied. Therefore, we set out to investigate whether distinct haplotypes of the two insertion/deletion polymorphisms in the serotonin-transporter-linked polymorphic region (5-HTTLPR) and the angiotensin I-converting enzyme (ACE) gene located on chromosome 17 can be identified as risk factors for trajectories of depression. Clinical and genotyping data were derived from 507 depressed CAD patients participating in the randomized, controlled, multicenter Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR-CAD) trial, of whom the majority had an acute cardiac event before study inclusion. Depression scores on the Hospital Anxiety and Depression Scale (HADS) were assessed at baseline and at five follow-up time points up to 2 years after study entrance. At baseline, depression scores did not significantly differ between patients carrying the risk haplotype ACE D/D, 5-HTTLPR I/I (n = 46) and the non-risk haplotypes (n = 461, 10.9 ± 2.7 versus 10.4 ± 2.5, p = 0.254). HADS-depression scores declined from study inclusion during the first year irrespective of the genotype. At each follow-up time point, HADS-depression scores were significantly higher in ACE D/D, 5-HTTLPR I/I carriers than in their counterparts. Two years after study inclusion, the mean HADS depression score remained 1.8 points higher in patients with the risk haplotype as compared to subjects not carrying this haplotype (9.9 ± 4.2 versus 8.1 ± 4.0, p = 0.009). In summary, the presence of the ACE D/D, 5-HTTLPR I/I haplotype may be a vulnerability factor for comorbid depressive symptoms in CAD patients.

Cognitive behavioral therapy in adolescents with early-onset psychosis: a randomized controlled pilot study.

Cognitive behavioral therapy for psychosis (CBT) is an effective treatment in adult patients with schizophrenia. However, no randomized controlled and blinded trial in adolescents with early-onset psychosis (EOP) has been conducted. Therefore, the present pilot study explores the acceptance, tolerability, feasibility, and safety of a modified CBT in adolescents with EOP. Twenty-five adolescents with EOP were randomized to either 9 months (20 sessions) of CBT + treatment as usual (TAU) or TAU alone. The primary endpoint was the PANSS-positive subscale (P1-7). Secondary endpoints included psychopathology, global functioning, and quality of life (QoL). Acceptance, tolerability, feasibility, and safety were assessed. Blinded assessments took place by the end of the treatment (9 months) and at 24-month follow-up. Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months. CBT in EOP was highly acceptable (73.5% agreed to randomization), well-tolerated (83.1% attendance rate, no drop-outs), and safe (one serious adverse event (SAE) in CBT + TAU in comparison with six SAEs in TAU). These findings suggest that CBT adapted to the needs of adolescents with EOP is a promising approach regarding negative symptoms, functioning, and QoL. CBT is a safe and tolerable treatment. However, due to the small sample size and the pilot character of the study, these conclusions are limited, and should be tested in a larger, adequately powered randomized controlled trial.

Video-assisted cardiopulmonary resuscitation via smartphone improves quality of resuscitation: A randomised controlled simulation trial.

BACKGROUND: Despite intensive research, cardiac arrest remains a leading cause of death. It is of paramount importance to undertake every possible effort to increase the overall quality of cardiopulmonary resuscitation (CPR) and improve patient outcome. CPR initiated by a bystander is one of the key factors in survival of such an incident. Telephone-assisted CPR (T-CPR) has proved to be an effective measure in improving layperson resuscitation. OBJECTIVE: We hypothesised that adding video-telephony to the emergency call (video-CPR, V-CPR) enhances the quality of layperson resuscitation. DESIGN: This randomised controlled simulation trial was performed from July to August 2018. Laypersons were randomly assigned to video-assisted (V-CPR), telephone-assisted (T-CPR) or control (unassisted CPR) groups. Participants were instructed to perform first aid on a mannequin during a simulated cardiac arrest. SETTING: This study was conducted in the Skills Lab of the University Hospital of Cologne. PARTICIPANTS: One hundred and fifty healthy adult volunteers. INTERVENTION: The participants received a smartphone to call emergency services, with Emergency Eye video-call in V-CPR group, and normal telephone functionality in the other groups. T-CPR and V-CPR groups received standardised CPR assistance via phone. MAIN OUTCOME MEASURES: Our primary endpoint was resuscitation quality, quantified by compression frequency and depth, and correct hand position. RESULTS: Mean compression frequency of V-CPR group was 106.4 ±â€Š11.7 min, T-CPR group 98.9 ±â€Š12.3 min (NS), unassisted group 71.6 ±â€Š32.3 min (P < 0.001). Mean compression depth was 55.4 ±â€Š12.3 mm in V-CPR, 52.1 ±â€Š13.3 mm in T-CPR (P < 0.001) and 52.9 ±â€Š15.5 mm in unassisted (P < 0.001). Total percentage of correct chest compressions was significantly higher (P < 0.001) in V-CPR (82.6%), than T-CPR (75.4%) and unassisted (77.3%) groups. CONCLUSION: V-CPR was shown to be superior to unassisted CPR, and was comparable to T-CPR. However, V-CPR leads to a significantly better hand position compared with the other study groups. V-CPR assistance resulted in volunteers performing chest compressions with more accurate compression depth. Despite reaching statistical significance, this may be of little clinical relevance. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT03527771).

Communication about the desire to die: Development and evaluation of a first needs-oriented training concept - A pilot study.

OBJECTIVE: Patients' desire to die (DD) is rarely discussed in palliative care (PC) due to health professionals' (HPs) feeling of uncertainty. The aim of the study was to develop and evaluate a training to increase HPs' self-confidence in responding professionally to patient's DD and to assess the feasibility of this approach. METHODS: The training course was developed via focus groups and relevant literature and refined with an advisory board. An evaluation design was developed to evaluate training outcomes and to examine feasibility. To assess self-confidence, knowledge, skills, and attitudes: (1) standardized surveys were applied at T1 (before training), T2 (directly after), and T3 (3 months later), and were analyzed by descriptive and non-parametric statistics; and (2) participants' open feedback was summarized by content. RESULTS: A two-day multi-disciplinary training was developed to improve self-confidence via diverse teaching methods. Twenty-four HPs from general and specialized PC were participated. Via self-rating on Likert scales at three time points, improvements were seen at T1, T2, and partly remained at T3, especially in the overall item of self-confidence in communicating with patients about their DD (means: 4.3. at T1, 5.7 at T2, and 5.9 at T3; on a 7-point scale with 1 = lowest value and 7 = highest value). Fewer improvements were found in skills (using different approaches) and attitudes (feeling less helplessness). Open feedback revealed a high appreciation for the training, especially the composition of participants, the role-play, and the overall increase of awareness of the topic. SIGNIFICANCE OF RESULTS: The developed training on addressing DD meets a need and was perceived by the participants to be of added value. Future research should measure training effects with a validated instrument, including more participants, diverse participant groups, and a control group. Effects on patients should be assessed.

Impact of regular professional toothbrushing on oral health, related quality of life, and nutritional and cognitive status in nursing home residents.

OBJECTIVES: The oral hygiene of nursing home residents is poor. We aimed to investigate the efficacy of professional brushing using a specialized brush every three weeks and its impact on geriatric outcomes. METHODS: Nursing home residents received professional brushing with a three-headed brush by a dental nurse every three weeks for three months. Controls comprised subjects from an earlier investigation. Their general clinical, geriatric and oral health (number of teeth, periodontitis, Gingivitis Index, Plaque Index, Root Caries Index, Volpe-Manhold Index [VMI]) were investigated, and Geriatric Oral Health Assessment Index (GOHAI) was obtained before and after three months. RESULTS: Forty nursing home residents were included. Seventy-six percent of participants suffered from periodontitis, while 48% had partial and 20% total dentures. After three months, VMI had decreased vs baseline (P < .001). An improvement in nutritional status (P = .012) was found in residents with dementia after the intervention, as well as an improvement in the GOHAI (P = .031) in all participants. Gingivitis and plaque indices did not improve. CONCLUSIONS: The oral health of nursing home residents is poor for various reasons, and nursing home staff cannot fully address the increased oral hygiene risk with increasing multimorbidity. Professional brushing performed regularly by a dental nurse is an efficient method to improve oral hygiene in nursing home residents and may contribute to better nutritional status and quality of life. However, brushing every three weeks with a three-headed brush was not effective at improving gingivitis or plaque and was inferior to the two-week brushing interval with a manual toothbrush.

Development of disorder-specific normative data for growth in children with cerebral palsy.

The purpose of this study was to create growth-percentiles for Caucasian children with cerebral palsy (CP). The studied parameters were height and age. In a retrospective analysis, we converted measurements collected in our center to create disorder-specific percentiles of normative data. Patients were stratified due to sex (male and female) and to mobility levels using the gross motor function classification system (GMFCS) (A = walking; GMFCS I-III, B = non walking; GMFCS IV-V) into four groups. In total, 2363 measurements in patients 0-18 years were collected. The mean age for group "Am" was 6.8 years (n = 862), group "Bm" 7.6 years (n = 563), group "Af" 7.7 years (n = 600), and group "Bf" 8.2 years (n = 366). The created percentiles for all groups were below the reference percentiles for healthy Caucasian children (KiGGS). The median curve for children with GMFCS levels I-III is slightly above the 3rd percentile, whereas the 50th percentile for GMFCS levels IV-V is mostly below the 3rd KiGGS centile.Conclusion: In conclusion, children with cerebral palsy are smaller than healthy children. The difference between 50th percentile of CP patients compared to healthy children supports the need for the use of disorder-specific growth charts. Those charts can help clinicians differentiate growth disorders in patients with CP. What is Known: • Children with cerebral palsy are shorter than healthy children and height is influenced by level of ambulation. • Currently, only reference percentiles of American children with mixed ethical backgrounds are available to evaluate growth. What is New: • This paper presents disorder-specific reference percentiles for longitudinal growth of Caucasian children with cerebral palsy depending on motor function. • These percentiles allow to asses longitudinal growth in children with cerebral palsy to detect other additional diseases impairing growth.

Efficacy of a newly developed mouth gel for xerostomia relief-A randomized double-blind trial.

OBJECTIVES: To determine the efficacy of a new symptom-relieving mouth gel vs. a widely used control gel on xerostomic burden. MATERIALS AND METHODS: This randomized, double-blind, crossover trial investigated the efficacy of the test gel (Dr. Wolff Gel) vs. control (Biotene) in participants with xerostomia (n = 32; mean age 60 years). Oral examinations were taken at baseline, and xerostomic visual analogue scales (xVAS), after-use questionnaires and willingness to pay were investigated before and after use. RESULTS: Neither gel reduced xerostomic burden (xVAS) after 7-day application. There was some preference for the test gel regarding taste and healthy gum feeling. After 1-time application, there were differences favouring the test gel for symptom-relieving effects between test gel and water (p < 0.001), mucosal adhesion (p < 0.001) and taste persistence (p < 0.001). Overall symptomatic relief with the test gel lasted around 2 hr. CONCLUSIONS: No mouth gel alleviated the overall xerostomic burden. Nevertheless, the test gel led to short-term perceived symptomatic relief and improved patient-centred outcomes as taste and perceived gum health. The gel will probably mainly be effective at moments that patients mostly suffer from xerostomia. Selection of a product will be based on perceived subjective differences and their value in the context of the overall xerostomic burden.

Efficacy and acceptance of professional dental cleaning among nursing home residents.

OBJECTIVES: To determine the impact of general and oral health status of nursing home residents in Germany on efficacy and acceptance of professional dental cleaning performed by a dental nurse. MATERIALS AND METHODS: Participants (N = 41; mean age 83 ± 8 years) living in a nursing home were included. Personal and general health, oral health, oral hygiene habits, and needs were investigated. Individual acceptance regarding professional dental cleaning via different devices (scaler, interdental brushes, ultrasonic cleaning) was assessed, as was the efficacy of this method using after-cleaning indices. RESULTS: Oral health among nursing home residents was impaired and independent from dementia status. Most residents (33/41) performed oral hygiene procedures independently and showed better index values than those in need of external help. Residents requiring help with oral hygiene showed increased risk profiles (higher age, more often immobile, demented, more xerostomia). The dental cleaning procedure required a mean time of 37 ± 11 min, was widely accepted (36/41), and achieved clean results (plaque index 0.1 ± 0.5, oral hygiene index 0.2 ± 1.6, Volpe-Manhold index 0.4 ± 1.6); food residues were reduced to 0 independent from cognitive status. Regarding the cleaning methods, scalers were accepted best without difference between demented and non-demented residents. CONCLUSIONS: Professional dental cleaning in nursing homes is an accepted and efficacious oral hygiene procedure among nursing home residents. CLINICAL RELEVANCE: Professional dental cleaning is an efficacious and accepted method as a first step in line with strategies to improve oral health and should be considered in nursing home residents.

The DEsire to DIe in Palliative care: Optimization of Management (DEDIPOM) - a study protocol.

BACKGROUND: A desire to die (DD) is frequent in palliative care (PC). However, uncertainty remains as to the appropriate therapeutic response. (Proactive) discussion of DD is not usually part of standard care. To support health practitioners' (HPs) reactions to a patient's DD, a training program has been developed, piloted and evaluated. Within this framework, a first draft of a semi-structured clinical interview schedule with prompts (CISP) has been developed, including recommendations for action to support HPs' self-confidence. The aim of this study is the further development of the CISP to support routine exploration of death and dying distress and proactive addressing of a DD. METHODS: This observatory, prospective health services study comprises a three step study design: 1. Revision of the CISP and consensus finding based on semi-structured interviews with patients and a Delphi process with (inter-)national experts, patient representatives and relatives; 2. Increasing confidence in HPs through a 2 day-training program using the consented CISP; 3. A formative quantitative evaluation of conversations between HPs and patients (300 palliative patients at three time points) and a qualitative evaluation based on interview triads of patients, relatives and HPs. The evaluation of conversations will include patient-oriented outcomes, including perceived relationships with HPs and death and dying distress. We will also consider aspects of social inequality and gender. DISCUSSION: The intervention can provide a framework for open discussion of DD and a basis for enhancing a trustful HP-patient relationship in which such difficult topics can be addressed. The benefits of this study will include (a) the creation of the first consented semi-structured approach to identify and address DD and to respond therapeutically, (b) the multi-professional enhancement of confidence in dealing with patients' DD and an intervention that can flexibly be integrated into other training and education programs and (c) an evaluation of effects of this intervention on patients, relatives and HPs, with attention to social inequality and gender. TRIAL REGISTRATION: The study is registered in the German Clinical Trials Register ( DRKS00012988 ; registration date: 27.9.2017) and in the Health Services Research Database ( VfD_DEDIPOM_17_003889 ; registration date: 14.9.2017).

Whole body vibration added to treatment as usual is effective in adolescents with depression: a partly randomized, three-armed clinical trial in inpatients.

There is growing evidence for the effectiveness of exercise in the treatment of adult major depression. With regard to adolescents, clinical trials are scarce. Due to the inherent symptoms of depression (lack of energy, low motivation to exercise), endurance training forms could be too demanding especially in the first weeks of treatment. We hypothesized that an easy-to-perform passive muscular training on a whole body vibration (WBV) device has equal anti-depressive effects compared to a cardiovascular training, both administered as add-ons to treatment as usual (TAU). Secondly, we presumed that both exercise interventions would be superior in their response, compared to TAU. In 2 years 64 medication-naïve depressed inpatients aged 13-18, were included. Both exercise groups fulfilled a supervised vigorous training for 6 weeks. Depressive symptoms were assessed by self-report ("Depressions Inventar für Kinder und Jugendliche"-DIKJ) before intervention and after weeks 6, 14 and 26. Compared to TAU, both groups responded earlier and more strongly measured by DIKJ scores, showing a trend for the WBV group after week 6 (p = 0.082). The decrease became statistically significant for both intervention groups after week 26 (p = 0.037 for ergometer and p = 0.042 for WBV). Remission rates amounted to 39.7% after week 6 and 66% after week 26, compared to 25% after week 26 in TAU. These results provide qualified support for the effectiveness of exercise as add-on treatment for medication-naïve depressed adolescents. The present results are limited by the not randomized control group.

Emergency department use during pregnancy: a prospective observational study in a single center institution.

PURPOSE: Gynecologists working in emergency department services in hospitals lately have the impression that the number of pregnant women who present themselves because of anxiety or uncertainty is increasing. Hence, the aim of this study was to assess reasons of pregnant women for presenting themselves to an emergency department. Of special interest was how far a diagnosis could be confirmed for the symptoms pregnant women complained about. METHODS: This is a prospective questionnaire-based study conducted between April 2015 and April 2016 in the Department of Gynecology and Obstetrics of the University Hospital of Cologne. The questionnaire was placed in the waiting area of the emergency department service for pregnant women. Pregnant patients were included with a gestational age of above 20 weeks of gestation. RESULTS: 331 patients were enrolled in this study. The most frequent reason for emergency department use was "pain" in 28.3% and cervical insufficiency in 19.7% of all cases. 45.6% (n = 151) of the patients had a recommendation of an outpatient practice for presentation to emergency department service. 36.3% (n = 120) of all patients were admitted to hospital for further treatment, 58.6% (n = 194) could be released from hospital. 3.3% (n = 11) of all patients rejected recommended further treatment in hospital. A trend was demonstrated concerning former abortion and hospital admission (p = 0.062). CONCLUSIONS: The high amount of patients making nonurgent use of emergency department services indicates potential uncertainty in interpretation of symptoms. Patients with former abortion history were admitted more often to hospital, and therefore need special attention during pregnancy.

Efficacy of GUM® Hydral versus Biotène® Oralbalance mouthwashes plus gels on symptoms of medication-induced xerostomia: a randomized, double-blind, crossover study.

OBJECTIVES: The objective of this study is to determine the efficacy of GUM® Hydral versus Biotène® Oralbalance (both a mouthwash plus gel) on the subjective burden and clinical symptoms of patients with medication-induced xerostomia. MATERIALS AND METHODS: Subjects (N = 40) with medication-induced xerostomia (minimum 4/10 mm visual analog scale [VAS]) were randomized to treatment with GUM Hydral or Biotène Oralbalance mouthwash, both with gel, for 28 days. Subjects then entered a 21-day wash-out period, before crossing over to the other treatment for 28 days. Outcomes measured included the VAS, German Oral Health Impact Profile (OHIPG)-14, Xerostomia Questionnaire (XQ), after-use questionnaire, and clinical parameters. RESULTS: Both GUM Hydral and Biotène Oralbalance significantly (p < 0.05) reduced VAS, OHIPG-14 total score and single items, and XQ Part 1 (oral dryness, oral pain, taste loss) and Part 2 items. GUM Hydral also significantly reduced the XQ Part 1 dysphagia score, while Biotène Oralbalance significantly reduced the halitosis organoleptic score and plaque index. Significant increases in saliva secretion did not reach clinical relevance. No significant between-group differences were observed, apart from OHIPG-14 items "trouble pronouncing words" and "uncertainty" in favor of GUM Hydral. No adverse effects were reported. CONCLUSIONS: Both products effectively improve oral health and xerostomia-related quality of life. However, they cannot completely substitute the continuous in-mouth secretion of saliva, and symptomatic relief is temporary. Product selection will be based on personal preference. CLINICAL RELEVANCE: Both products diminish xerostomic burden and should be part of the management strategy. Affected patients should be informed of these treatments, since no adverse effects were reported.

Removal of Soluble Fms-Like Tyrosine Kinase-1 by Dextran Sulfate Apheresis in Preeclampsia.

Preeclampsia is a devastating complication of pregnancy. Soluble Fms-like tyrosine kinase-1 (sFlt-1) is an antiangiogenic protein believed to mediate the signs and symptoms of preeclampsia. We conducted an open pilot study to evaluate the safety and potential efficacy of therapeutic apheresis with a plasma-specific dextran sulfate column to remove circulating sFlt-1 in 11 pregnant women (20-38 years of age) with very preterm preeclampsia (23-32 weeks of gestation, systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, new onset protein/creatinine ratio >0.30 g/g, and sFlt-1/placental growth factor ratio >85). We evaluated the extent of sFlt-1 removal, proteinuria reduction, pregnancy continuation, and neonatal and fetal safety of apheresis after one (n=6), two (n=4), or three (n=1) apheresis treatments. Mean sFlt-1 levels were reduced by 18% (range 7%-28%) with concomitant reductions of 44% in protein/creatinine ratios. Pregnancy continued for 8 days (range 2-11) and 15 days (range 11-21) in women treated once and multiple times, respectively, compared with 3 days (range 0-14) in untreated contemporaneous preeclampsia controls (n=22). Transient maternal BP reduction during apheresis was managed by withholding pre-apheresis antihypertensive therapy, saline prehydration, and reducing blood flow through the apheresis column. Compared with infants born prematurely to untreated women with and without preeclampsia (n=22 per group), no adverse effects of apheresis were observed. In conclusion, therapeutic apheresis reduced circulating sFlt-1 and proteinuria in women with very preterm preeclampsia and appeared to prolong pregnancy without major adverse maternal or fetal consequences. A controlled trial is warranted to confirm these findings.

Effect evaluation of an interprofessional medication therapy management approach for multimorbid patients in primary care: a cluster-randomized controlled trial in community care (WestGem study protocol).

BACKGROUND: Pharmaceutical practice worldwide is developing towards patient care. Medication Review (MR) and Medication Therapy Management (MTM) are evolving as the most prominent services in pharmaceutical care and have a strong potential to provide a large benefit for patients and society. MTMs can only be performed in an interprofessional, collaborative setting. Several international studies have explored the effects of a MTM on the quality of therapy and costs. For Germany the data is still deficient. This study aims to provide data on the effects of an interprofessional MTM regarding quality of therapy, quality of life, costs and cost-effectiveness. METHOD/DESIGN: The study is designed as a cluster-randomized controlled trial in primary care, involving 12 outpatient clinics (clusters) and 165 patients. Primary care units are allocated to interventions using a Stepped Wedge Design. All units are initially assigned to the control group. After a 6 month observation period, general practitioners (GP) are randomly allocated to one of three groups and the interprofessional medication therapy management approach is implemented sequentially per each group with a lag of 3 months between. The primary outcome is the change in the quality of therapy measured by the MAI (Medication Appropriateness Index). Secondary outcomes include changes in the number of drug related problems, medication complexity, changes in drug-adherence, changes in health-status and function, quality of life, direct costs and the incremental cost-effectiveness ratio. The acceptance of the interprofessional Medication Therapy Management approach is assessed by qualitative methods. DISCUSSION: The patient interview and brown bag review are activities, typically provided by the pharmacist. In this trial the patient is blinded to the pharmacist. The strength of having the patient blinded to the pharmacists is to exclude skepticism of the patient toward unknown pharmacies, which might be a major confounder in a regional and community setting. A weakness is that some patient related data might reach the pharmacists in a way, which might differ from self-acquired data. TRIAL REGISTRATION: Current controlled trials ISRCTN41595373 .