End-of-life practices in 11 German intensive care units : Results from the ETHICUS-2 study.

BACKGROUND: End-of-life care is common in German intensive care units (ICUs) but little is known about daily practice. OBJECTIVES: To study the practice of end-of-life care. METHODS: Prospectively planned, secondary analysis comprising the German subset of the worldwide Ethicus­2 Study (2015-2016) including consecutive ICU patients with limitation of life-sustaining therapy or who died. RESULTS: Among 1092 (13.7%) of 7966 patients from 11 multidisciplinary ICUs, 967 (88.6%) had treatment limitations, 92 (8.4%) died with failed CPR, and 33 (3%) with brain death. Among patients with treatment limitations, 22.3% (216/967) patients were discharged alive from the ICU. More patients had treatments withdrawn than withheld (556 [57.5%] vs. 411 [42.5%], p < 0.001). Patients with treatment limitations were older (median 73 years [interquartile range (IQR) 61-80] vs. 68 years [IQR 54-77]) and more had mental decision-making capacity (12.9 vs. 0.8%), advance directives (28.6 vs. 11.2%), and information about treatment wishes (82.7 vs 33.3%, all p < 0.001). Physicians reported discussing treatment limitations with patients with mental decision-making capacity and families (91.3 and 82.6%, respectively). Patient wishes were unknown in 41.3% of patients. The major reason for decision-making was unresponsiveness to maximal therapy (34.6%). CONCLUSIONS: Treatment limitations are common, based on information about patients' wishes and discussion between stakeholders, patients and families. However, our findings suggest that treatment preferences of nearly half the patients remain unknown which affects guidance for treatment decisions.

[Decision-making support in Intensive Care to facilitate organ donation : Position paper of the Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine (DGIIN)]. / Entscheidungshilfe bei erweitertem intensivmedizinischem Behandlungsbedarf auf dem Weg zur Organspende : Positionspapier der Sektion Ethik und der Sektion Organspende und -transplantation der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

BACKGROUND AND CHALLENGE: Injuries, especially traumatic brain injury, or specific illnesses and their respective sequelae can result in the demise of the patients afflicted despite all efforts of modern intensive care medicine. If in principle organ donation is an option after a patient's death, intensive therapeutic measures are regularly required in order to maintain the homeostasis of the organs. These measures, however, cannot benefit the patient afflicted anymore-which in turn might lead to an ethical conflict between dignified palliative care for him/her and expanded intensive treatment to facilitate organ donation for others, especially if the patient has opted for the limitation of life-sustaining therapies in an advance directive. METHOD: The Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) have convened several meetings and a telephone conference and have arrived at a decision-making aid as to the extent of treatment for potential organ donors. This instrument focusses first on the assessment of five individual dimensions regarding organ donation, namely the certitude of a complete and irreversible loss of all brain function, the patient's wishes as to organ donation, his or her wishes as to limiting life-sustaining therapies, the intensity of expanded intensive treatment for organ protection and the odds of its successful attainment. Then, the combination of the individual assessments, as graphically shown in a {Netzdiagramm}, will allow for a judgement as to whether a continuation or possibly an expansion of intensive care measures is ethically justified, questionable or even inappropriate. RESULT: The aid described can help mitigate ethical conflicts as to the extent of intensive care treatment for moribund patients, when organ donation is a medically sound option. NOTE: Gerald Neitzke und Annette Rogge contributed equally to this paper and should be considered co-first authors.

[Amendment to the documentation of decisions to withhold or withdraw life-sustaining therapies in consideration of wish to donate organs : Recommendation of the Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine (DGIIN)]. / Ergänzung des Dokumentationsbogens "Therapiebegrenzung" unter Berücksichtigung eines möglichen Organspendewunsches : Empfehlung der Sektion Ethik sowie der Sektion Organspende und Organtransplantation der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

The Ethics Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) recently published a documentation for decisions to withhold or withdraw life-sustaining therapies. The wish to donate organs was not considered explicitly. Therefore the Ethics Section and the Organ Donation and Transplantation Section of the DIVI together with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine worked out a supplementary footnote for the documentation form to address the individual case of a patient's wish to donate organs.

[Non-beneficial therapy and emotional exhaustion in end-of-life care : Results of a survey among intensive care unit personnel]. / Übertherapie und emotionale Erschöpfung in der "end-of-life care" : Ergebnisse einer Mitarbeiterumfrage auf der Intensivstation.

BACKGROUND: End-of-life care (EOLC) in the intensive care unit (ICU) is becoming increasingly more common but ethical standards are compromised by growing economic pressure. It was previously found that perception of non-beneficial treatment (NBT) was independently associated with the core burnout dimension of emotional exhaustion. It is unknown whether factors of the work environment also play a role in the context of EOLC. OBJECTIVE: Is the working environment associated with perception of NBT or clinician burnout? MATERIAL AND METHODS: Physicians and nursing personnel from 11 German ICUs who took part in an international, longitudinal prospective observational study on EOLC in 2015-2016 were surveyed using validated instruments. Risk factors were obtained by multivariate multilevel analysis. RESULTS: The participation rate was 49.8% of personnel working in the ICU at the time of the survey. Overall, 325 nursing personnel, 91 residents and 26 consulting physicians participated. Nurses perceived NBT more frequently than physicians. Predictors for the perception of NBT were profession, collaboration in the EOLC context, excessively high workload (each p ≤ 0.001) and the numbers of weekend working days per month (p = 0.012). Protective factors against burnout included intensive care specialization (p = 0.001) and emotional support within the team (p ≤ 0.001), while emotional exhaustion through contact with relatives at the end of life and a high workload were both increased (each p ≤ 0.001). DISCUSSION: Using the example of EOLC, deficits in the work environment and stress factors were uncovered. Factors of the work environment are associated with perceived NBT. To reduce NBT and burnout, the quality of the work environment should be improved and intensive care specialization and emotional support within the team enhanced. Interprofessional decision-making among the ICU team and interprofessional collaboration should be improved by regular joint rounds and interprofessional case discussions. Mitigating stressful factors such as communication with relatives and high workload require allocation of respective resources.

Outcome in patients perceived as receiving excessive care across different ethical climates: a prospective study in 68 intensive care units in Europe and the USA.

PURPOSE: Whether the quality of the ethical climate in the intensive care unit (ICU) improves the identification of patients receiving excessive care and affects patient outcomes is unknown. METHODS: In this prospective observational study, perceptions of excessive care (PECs) by clinicians working in 68 ICUs in Europe and the USA were collected daily during a 28-day period. The quality of the ethical climate in the ICUs was assessed via a validated questionnaire. We compared the combined endpoint (death, not at home or poor quality of life at 1 year) of patients with PECs and the time from PECs until written treatment-limitation decisions (TLDs) and death across the four climates defined via cluster analysis. RESULTS: Of the 4747 eligible clinicians, 2992 (63%) evaluated the ethical climate in their ICU. Of the 321 and 623 patients not admitted for monitoring only in ICUs with a good (n = 12, 18%) and poor (n = 24, 35%) climate, 36 (11%) and 74 (12%), respectively were identified with PECs by at least two clinicians. Of the 35 and 71 identified patients with an available combined endpoint, 100% (95% CI 90.0-1.00) and 85.9% (75.4-92.0) (P = 0.02) attained that endpoint. The risk of death (HR 1.88, 95% CI 1.20-2.92) or receiving a written TLD (HR 2.32, CI 1.11-4.85) in patients with PECs by at least two clinicians was higher in ICUs with a good climate than in those with a poor one. The differences between ICUs with an average climate, with (n = 12, 18%) or without (n = 20, 29%) nursing involvement at the end of life, and ICUs with a poor climate were less obvious but still in favour of the former. CONCLUSION: Enhancing the quality of the ethical climate in the ICU may improve both the identification of patients receiving excessive care and the decision-making process at the end of life.

Effectiveness of an Ayurveda treatment approach in knee osteoarthritis - a randomized controlled trial.

OBJECTIVE: Ayurveda is commonly used in South Asia to treat knee osteoarthritis (OA). We aimed to evaluate the effectiveness of Ayurvedic treatment compared to conventional conservative care in patients with knee OA. METHOD: According to American College of Rheumatology (ACR) criteria knee OA patients were included in a multicenter randomized, controlled, open-label trial and treated in 2 hospital clinics and 2 private outpatient clinics in Germany. Participants received either a multi-modal Ayurvedic treatment or multi-modal conventional care with 15 treatments over 12 weeks respectively. Primary outcome was the change on the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index after 12 weeks. Secondary outcomes included WOMAC subscales; the pain disability index and a pain experience scale, numeric rating scales for pain and sleep quality, quality-of-life and mood, rescue medication use, and safety issues. RESULTS: One hundred fifty-one participants (Ayurveda n = 77, conventional care n = 74) were included. Changes of the WOMAC Index from baseline to 12 weeks were more pronounced in the Ayurveda group (mean difference 61.0 [95%CI: 52.4;69.6]) than in the conventional group (32.0 [95%CI: 21.4;42.6]) resulting in a significant between-group difference (p < 0.001) and a clinically relevant effect size (Cohen's d 0.68 [95% CI:0.35;1.01]). Similar trends were observed for all secondary outcomes at week 12. Effects were sustained at follow-ups after 6 and 12 months. CONCLUSION: Results suggest that Ayurvedic treatment is beneficial in reducing knee OA symptoms. Further studies should be conducted to confirm the magnitude of the effect and to clarify the role of different treatment components and non-specific effects. REGISTRATION: at clinicaltrials.gov (NCT01225133; initial release 10/06/2010).

A case series of the effects of a novel composition of a traditional natural preparation for the treatment of psoriasis.

The objective of this study was to assess the effectiveness of a specific composition of a traditional herbal preparation (DurrDerma) in adult patients with moderate to severe skin psoriasis. The preparation is a newly developed topical combination containing plant-based extracts traditionally used in skin disease as black cumin, olive oil, tea tree oil, cocoa butter completed by vitamin A and vitamin B12. We documented the effectiveness of the preparation in a first case series. A total of 12 patients (8 males and 4 females, 21-86 y) with manifest and treatment-resistant psoriasis were included and treated for 12 weeks. All patients were assigned to twice-daily treatment with the DurrDerma preparation. Treatment success as determined by the Psoriasis Area and Severity Index (PASI) score, the body surface area, and the dermatology life index was achieved (PASI reduction of >75%) in 10 of the 12 treated patients (83%). The remaining two patients showed a PASI reduction of ≤50%. In 5 of the patients PASI reduction was achieved <12 weeks (between week 3-11). The beneficial effect in responder patients might be explained by a synergistic anti-oxidative and anti inflammatory activity of all components present in DurrDerma. We conclude that the new preparation using a traditional approach seems to be a promising complementary treatment for psoriasis.

Effects of high phenolic olive oil on cardiovascular risk factors: A systematic review and meta-analysis.

BACKGROUND: Cardiovascular diseases are the world's leading cause of death. Prevention by nutrition is an easy and effective approach especially by advising foods with nutraceutic properties like high phenolic olive oil (HPOO). AIM: The aim of this review was to systematically access and meta-analyse the effects of HPOO on risk factors of the cardiovascular system and thusly to evaluate its use as a nutraceutical in prevention. DATA SYNTHESIS: Medline/PubMed, EMBase, the Cochrane Library, CAMbase and CAM-QUEST were searched through July 2013. Randomized controlled trials (RCTs) comparing high vs. low (resp. non) phenolic olive oils in either healthy participants or patients with cardiovascular diseases were included. For study appraisal the Cochrane Collaboration's risk of bias tool was used. Main outcomes were blood pressure, serum lipoproteins and oxidation markers. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated and analysed by the generic inverse variance methods using a random effects model. Eight cross over RCTs comparing ingestion (21-90 d) of high vs. low (resp. non) phenolic olive oils with a total of 355 subjects were included. RESULTS: There were medium effects for lowering systolic blood pressure (n = 69; SMD -0.52; CI -0.77/-0.27; p < 0.01) and small effects for lowering oxLDL (n = 300; SMD -0.25; CI [-0.50/0.00]; p = 0.05). No effects were found for diastolic blood pressure (n = 69; SMD -0.20; CI -1.01/0.62; p = 0.64); malondialdehyde (n = 71; SMD -0.02; CI [-0.20/0.15]; p = 0.79), total cholesterol (n = 400; SMD -0.05; CI [-0.16/0.05]; p = 0.33); HDL (n = 400; SMD -0.03; CI [-0.14/0.08]; p = 0.62); LDL (n = 400; SMD -0.03; CI [-0.15/0.09]; p = 0.61); and triglycerides (n = 360; SMD 0.02; CI [-0.22/0.25]; p = 0.90). LIMITATIONS: The small number of studies/participants limits this review. CONCLUSIONS: HPOO provides small beneficial effects on systolic blood pressure and serum oxidative status (oxLDL). HPOO should be considered as a nutraceutical in cardiovascular prevention.

Ayurveda: between religion, spirituality, and medicine.

Ayurveda is playing a growing part in Europe. Questions regarding the role of religion and spirituality within Ayurveda are discussed widely. Yet, there is little data on the influence of religious and spiritual aspects on its European diffusion. Methods. A survey was conducted with a new questionnaire. It was analysed by calculating frequency variables and testing differences in distributions with the χ (2)-Test. Principal Component Analyses with Varimax Rotation were performed. Results. 140 questionnaires were analysed. Researchers found that individual religious and spiritual backgrounds influence attitudes and expectations towards Ayurveda. Statistical relationships were found between religious/spiritual backgrounds and decisions to offer/access Ayurveda. Accessing Ayurveda did not exclude the simultaneous use of modern medicine and CAM. From the majority's perspective Ayurveda is simultaneously a science, medicine, and a spiritual approach. Conclusion. Ayurveda seems to be able to satisfy the individual needs of therapists and patients, despite worldview differences. Ayurvedic concepts are based on anthropologic assumptions including different levels of existence in healing approaches. Thereby, Ayurveda can be seen in accordance with the prerequisites for a Whole Medical System. As a result of this, intimate and individual therapist-patient relationships can emerge. Larger surveys involving bigger participant numbers with fully validated questionnaires are warranted to support these results.

Mindful walking in psychologically distressed individuals: a randomized controlled trial.

Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen's Perceived Stress Scale (CPSS) after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001). Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

Randomised clinical trial: a herbal preparation of myrrh, chamomile and coffee charcoal compared with mesalazine in maintaining remission in ulcerative colitis--a double-blind, double-dummy study.

BACKGROUND: The herbal treatment with myrrh, dry extract of chamomile flowers and coffee charcoal has anti-inflammatory and antidiarrhoeal potential and might benefit patients with UC. Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis (UC). AIM: To compare the efficacy of the two treatments in maintaining remission in patients with ulcerative colitis. METHODS: We performed a randomised, double-blind, double-dummy study over a 12-month period in patients with UC. Primary endpoint was non-inferiority of the herbal preparation as defined by mean Clinical Colitis Activity Index (CAI-Rachmilewitz). Secondary endpoints were relapse rates, safety profile, relapse-free times, endoscopic activity and faecal biomarkers. RESULTS: A total of 96 patients (51 female) with inactive UC were included. Mean CAI demonstrated no significant difference between the two treatment groups in the intention-to-treat (P = 0.121) or per-protocol (P = 0.251) analysis. Relapse rates in total were 22/49 patients (45%) in the mesalazine treatment group and 25/47 patients (53%) in the herbal treatment group (P = 0.540). Safety profile and tolerability were good and no significant differences were shown in relapse-free time, endoscopy and faecal biomarkers. CONCLUSIONS: The herbal preparation of myrrh, chamomile extract and coffee charcoal is well tolerated and shows a good safety profile. We found first evidence for a potential efficacy non-inferior to the gold standard therapy mesalazine, which merits further study of its clinical usefulness in maintenance therapy of patients with ulcerative colitis. EudraCT-Number 2007-007928-18.

Impact of stimulation dose and personality on autonomic and psychological effects induced by acupuncture.

Acupuncture has been shown to exhibit distinct effects on the autonomic nervous system. We tested whether the autonomic and psychological response to acupuncture depends on the stimulation dose and the personality of the treated subjects. 52 healthy subjects were randomized to receive either low dose (one needle at point Hegu bilaterally) or high dose (additional 4 needles at non-acupoints bilaterally) acupuncture stimulation after stratification according to their personality to "reduce" or "augment" incoming stimuli. Outcomes were changes of electrodermal activity (EDA), high frequency component of heart rate variability, heart rate, mean arterial blood pressure, respiration rate and subjective parameters for psychological well being and perceived intensity of needling. Electrodermal activity increased during needle insertion and decreased under baseline when subjects were resting with the needles in the body for 20 min. The initial EDA increase was significantly (GEE ANCOVA p<0.001) more pronounced during high dose stimulation and independent of personality. All other physiological parameters did not show any significant group effect. Strong stimulated augmenters perceived acupuncture most painful and increased with their psychological activation after the acupuncture session in contrast to the other groups, which showed a decrease of activation in the pre-post comparison (overall group effect p=0.032). The data indicate that during needle insertion high dose acupuncture stimulation leads to a higher increase of sympathetic nerve activity than low dose stimulation independent of personality. After needle insertion subjects who tend to augment incoming stimuli might show a lack of psychological relaxation when receiving high dose stimulation.

[Burn-out in anesthesia and intensive care medicine. Part 1. Clarification and critical evaluation of the term]. / Burn-out in Anästhesie und Intensivmedizin. Teil 1: Klärung und kritische Wertung des Begriffs.

Both acute critical life events and circumstances continuously perceived as strenuous may lead to psychomental and somatic symptoms. The term burn-out as an expression for chronic occupational stress has become a popular catchword over the last years. Employees in many occupations feel especially prone to burn-out due to a work environment perceived as increasingly intense and commercialized. Physicians and nurses also appear to be considerably affected by burn-out, including those working in anesthesiology and intensive care medicine. However, there is a scarcity of reliable occupation-specific data to corroborate this notion. Even though the classic concept of burn-out and the Maslach Burnout Inventory have been used for many years, a critical appraisal shows that burn-out has not yet been recognized as a diagnostic entity. Presumably there are other concepts and psychometric instruments more capable of collecting epidemiologic data regarding chronic work-related stress. With enhanced data, perhaps, measures based on principles of public health can be created and evaluated for the prevention and treatment of this condition.

[Burnout in anesthesia and intensive care medicine. Part 2: Epidemiology and importance for the quality of care]. / Burn-out in Anästhesie und Intensivmedizin. Teil 2: Epidemiologie und Bedeutung für die Versorgungsqualität.

Physicians and nurses in anesthesia and critical care medicine are thought to be particularly prone to developing burnout. Epidemiologic data, however, are inconclusive especially because not all of the studies presented here are methodologically sound. Nevertheless, the following conclusions appear reasonable: in several European countries burnout is seen as a relevant problem in anesthesia and critical care medicine with a point-prevalence for moderate or severe burnout, as determined with the Maslach Burnout Inventory, at approximately 30% among nurses and approximately 40-50% among physicians. Determinants correlated with burnout can be found among the individual characteristics of those affected and within the occupational realm (for example high workload and insufficient control over the work routine). The actual severity of the patients' illness does not correlate with the degree of the healthcare workers' burnout. Notwithstanding a plethora of "how to" literature, there are no preventive or therapeutic measures which could meet the scientific requirements for guidelines. Stress management programs appear to be somewhat efficacious although there are no studies to date for the clientele featured in this publication. Multimodal therapy can be recommended for pronounced burnout, including occupation-related treatment modalities. However, a general open mind towards warning signs of chronic stress disorder on the individual level as well as an adequate gratification for the work performance and sufficient control over the work routine on an organizational level appear to be among the important preventive measures.