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Anna Marie Balestra, Katharina Chalk, Claudia Spies, Claudia Denke, Henning Krampe, Sascha Tafelski Department of Anesthesiology and Intensive Care Medicine, Charité – Universitätsmedizin Berlin, Berlin, GermanyCorrespondence: Anna Marie Balestra, Department of Anesthesiology and Intensive Care Medicine, Charité – Universitätsmedizin Berlin, Berlin, Germany, Tel +49 30 450 631 014, Fax +49 30 450 531 904, Email anna-marie.balestra@charite.dePurpose: COVID-19 pandemic containment measures have led to changes in various areas of life, including restrictions on health care. Patients with chronic pain may have faced an increased burden during pandemic and the resources of this vulnerable population are unknown. Therefore, a qualitative study was conducted to understand how people with chronic pain have experienced the course of the pandemic.Patients and Methods: Twenty semi-structured telephone interviews were conducted six months after the initial lockdown in Germany. The participants were patients with chronic pain who exhibited varying changes in their pain during the first German lockdown, recruited from a German outpatient pain clinic at a Department of Anesthesiology and Intensive Care. The semi-structured interview guidelines were designed to explore how patients with chronic pain experienced their pain during the pandemic, how they coped, and how they experienced pain management during this time. The interview recordings were transcribed verbatim and coded using the qualitative content analysis method.Results: Four themes emerged from the results: differential impact on pain experience, difficulty coping with pain, supportive pain management, and endurance.Conclusion: During this uncertain time, it was particularly important to maintain pain treatment in order to establish a sense of safety and stability. This underscores the special role of maintaining therapeutic contact during a pandemic and the potentially special role of telemedicine.Keywords: COVID-19 pandemic, telemedicine, mental distress, coping, chronic pain

Objectives: To compare ICU survivors' subjective mental and functional health before ICU admission and after discharge and to assess determinants of subjective health decline or improvement., Design: Secondary analysis of the multicenter cluster-randomized Enhanced Recovery after Intensive Care trial ( ClinicalTrials.gov : NCT03671447)., Setting: Ten ICU clusters in Germany., Patients: Eight hundred fifty-five patients with 1478 follow-up assessments., Interventions: None., Measurements and Main Results: At two patient follow-ups scheduled 3 and 6 months after ICU discharge, patients rated their subjective mental and functional/physical health on two separate visual analog scales from 0 (worst) to 10 (best) in the previous week and before ICU admission. We compared pre-ICU and post-ICU subjective health and used mixed-effects regression to assess determinants of a health decline or improvement. At the first follow-up, 20% ( n = 165/841) and 30% ( n = 256/849) of patients reported a decline in subjective mental and functional health of at least three points, respectively; 16% ( n = 133/841 and n = 137/849) outlined improvements of mental and functional health. For 65% ( n = 543/841) and 54% ( n = 456/849), mental and functional health did not change three points or more at the first follow-up. Multivariable mixed-effects logistic regressions revealed that the ICU length of stay was a predictor of mental (adjusted odds ratio [OR] per ICU day, 1.04; 95% CI, 1.00-1.09; p = 0.038) and functional health (adjusted OR per ICU day, 1.06; 95% CI, 1.01-1.12; p = 0.026) decline. The odds of a mental health decline decreased with age (adjusted OR per year, 0.98; 95% CI, 0.96-0.99; p = 0.003) and the odds of a functional health decline decreased with time after discharge (adjusted OR per month, 0.86; 95% CI, 0.79-0.94; p = 0.001)., Conclusions: The majority of ICU survivors did not experience substantial changes in their subjective health status, but patients with long ICU stays were prone to subjective mental and functional health decline. Hence, post-ICU care in post-ICU clinics could focus on these patients., Competing Interests: Drs. Paul’s, Cittadino’s, Spies’s, and Weiss’s institution received funding from the German Innovation Fund of the Federal Joint Committee during the conduct of the study. Outside the submitted work, Dr. Paul reports financial support for attending meetings and travel from Teladoc Health. Dr. Spies’ institution received funding from the Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)/German Aerospace Center and the Einstein Stiftung Berlin/Einstein Foundation Berlin; she disclosed Inner University Grants, grants from Projektträger im Deutsches Zentrum für Luft- und Raumfahrt e. V., Project Management Agency, grants from Stifterverband, Nonprofit Society Promoting Science and Education, grants from European Society of Anaesthesiology and Intensive Care, grants from the Federal Ministry for Economic Affairs and Climate Action, personal fees from Georg Thieme Verlag, grants from Dr. Franz Köhler Chemie GmbH, grants from Sintetica GmbH, grants from Max-Planck-Gesellschaft zur Förderung der Wissenschaften e. V., grants from Stifterverband für die deutsche Wissenschaft e. V., Metronic, grants from Philips Electronics Nederland BV, grants from Federal Ministry of Education and Research (BMBF), grants from BMBF/Robert Koch Institute (RKI), and grants from Deutsche Forschungsgemeinschaft/German Research Society; she disclosed ownership of patent 15753 627.7 issued in Europe (Germany/Austria/Switzerland/Liechtenstein/France/United Kingdom/The Netherlands) as inventor, a U.S. patent PCT/EP 2015/067731 issued as inventor, a patent 3 174 588 issued in Europe (Germany/Switzerland/Liechtenstein/France/The Netherlands) as inventor, an international patent 10 2014 215 211.9 licensed, an international patent 10 2018 114 364.8 licensed, an international patent 10 2018 110 275.5 licensed, an international patent 50 2015 010 534.8 licensed, an international patent 50 2015 010 347.7 licensed, and an international patent 10 2014 215 212.7 licensed; she disclosed an unpaid role in the Association of the Scientific Medical Societies in Germany, an unpaid role in the German Research Foundation review boards, and an unpaid membership role in the German National Academy of Sciences—Leopoldina. Dr. Weiss’ institution received funding from the Federal Joint Committee (Enhanced Recovery after Intensive Care 01NVF16011); he received funding from the German Ministry of Health, Orion Pharma, Dr. Franz Köhler Chemie, and Teladoc Health GmbH; he disclosed participation on the Delirium-Task-Force Advisory Board of the European Society of Intensive Care Medicine; and he disclosed position as regional chair of the state of Berlin of the German Society of Anesthesiology and Intensive Care. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.)

The improvement of intensive care treatment options leads to an increasing number of patients being treated in this setting. For the majority of those affected and their relatives, this treatment is associated with tremendous stress, but also subsequent physical, psychological and cognitive impairments, the post-intensive care syndrome. The aim of psychosocial support in the intensive care unit is to stabilise and minimise the acute stress. This is done through care services oriented towards trauma therapy interventions and emergency psychology. Equally central are the needs of the patient's relatives and ways to stabilise and relieve them. The third pillar of psychosocial work in the intensive care unit is the support of the treatment team. Finally, an outlook is given for the specialised aftercare of these complex patients in PICS outpatient clinics., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

The treatment of chronic pain with cannabinoids is becoming more widespread and popular among patients. However, studies show that only a few patients experience any benefit from this treatment. It also remains unclear which domains are affected by cannabinoid treatment. Therefore, the present study is novel in that it explores the effects of cannabinoid treatment on four patient-related outcome measures (PROMs), and includes patients with chronic refractory pain conditions who have been given the option of cannabinoid treatment. A retrospective design was used to evaluate the impact of cannabinoid treatment on patients with refractory pain in two German outpatient pain clinics. The present study shows that pain intensity (mean relative reduction (-14.9 ± 22.6%), emotional distress (-9.2 ± 43.5%), pain-associated disability (-7.0 ± 46.5%) and tolerability of pain (-11 ± 23.4%)) improved with cannabinoid treatment. Interestingly, the trajectories of the PROMs seemed to differ between patients, with only 30% of patients responding with respect to pain intensity, but showing improvements in other PROMs. Although the mean treatment effects remained limited, the cumulative magnitude of change in all dimensions may affect patients' quality of life. In summary, a singular evaluation with pain intensity as the sole outcome does not cover the multidimensional effects of cannabinoids. Therefore, the treatment effects of cannabinoids should be evaluated with different PROMs.

Objectives: Survivors of critical illness commonly show impaired health-related quality of life (HrQoL). We investigated if HrQoL can be approximated by brief, easily applicable items to be used in primary care., Design: Secondary analysis of data from the multicenter, cluster-randomized controlled Enhanced Recovery after Intensive Care trial ( ClinicalTrials.gov : NCT03671447) and construct validity study., Setting: Ten participating clusters of ICUs in the metropolitan area of Berlin, Germany., Patients: Eight hundred fifty ICU survivors enrolled in a mixed, medical or surgical ICU when they had an expected ICU length of stay of at least 24 hours, were at least 18 years old, and had statutory health insurance coverage., Interventions: None., Measurements and Main Results: Patients received follow-ups scheduled 3 and 6 months after ICU discharge. HrQoL was assessed with the EuroQol 5-Dimension 5-Level (EQ-5D-5L), and patients were asked to rate their current mental and physical health state from 0 (worst) to 10 (best). We fitted prediction models for the EQ-5D-5L index value using these two items and additional covariates, applying stepwise regression and adaptive lasso. Subjective mental health (Spearman: 0.59) and subjective physical health (Spearman: 0.68) correlated with EQ-5D-5L index values and were better predictors of EQ-5D-5L index values in the two-item regression (normalized root mean squared error [nRMSE] 0.164; normalized mean absolute error [nMAE] 0.118; R2adj 0.43) than the EQ-5D Visual Analog Scale (nRMSE 0.175; nMAE 0.124; R2adj 0.35). Stepwise regression with additional covariates further increased prediction performance (nRMSE 0.133; nMAE 0.1; R2adj 0.51)., Conclusions: Asking patients to rate their subjective mental and physical health can be an easily applicable tool for a first impression of the HrQoL in primary care settings., Competing Interests: Drs. Paul, Weiss, and Spies reports grants from Gemeinsamer Bundesausschuss (G-BA)/Federal Joint Committee—Innovationsfonds during the conduct of the study. Drs. Cittadino, Krampe, and Denke declare no conflicts of interest. Outside the submitted work, Dr. Weiss reports grants from the European Society of Intensive Care Medicine (ESICM), consulting fees from OrionPharma Ltd., honoraria from Dr. F. Köhler Chemie, support for attending meetings and travel from Teladoc Health, a leadership role as ESICM NEXT Chair, a member role in the ESICM ARDS Guideline group, and a member role in the COVRIIN Group of the Robert Koch Institute. Outside the submitted work, Dr. Spies reports grants from Deutsche Forschungsgemeinschaft/German Research Society, grants from Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)/German Aerospace Center, grants from Projektträger im DLR/Project Management Agency, grants from Stifterverband/Non-Profit Society Promoting Science and Education, grants from European Society of Anaesthesiology and Intensive Care, grants from Baxter Deutschland GmbH, grants from Cytosorbents Europe GmbH, grants from Edwards Lifesciences Germany GmbH, grants from Fresenius Medical Care, grants from Grünenthal GmbH, grants from Masimo Europe Ltd., grants from Pfizer Pharma PFE GmbH, personal fees from Georg Thieme Verlag, grants from Dr. F. Köhler Chemie GmbH, grants from Sintetica GmbH, grants from Stifterverband für die deutsche Wissenschaft e.V./Philips, grants from Stiftung Charité, grants from AGUETTANT Deutschland GmbH, grants from AbbVie Deutschland GmbH & Co. KG, grants from Amomed Pharma GmbH, grants from InTouch Health, grants from Copra System GmbH, grants from Correvio GmbH, grants from G-BA/Federal Joint Committee—Innovationsfonds, grants from Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V., grants from Deutsche Gesellschaft für Anästhesiologie & Intensivmedizin, grants from Stifterverband für die deutsche Wissenschaft e.V./Metronic, grants from Philips ElectronicsNederland BV, grants from BMBF—Federal Ministry of Education and Research, grants from BMBF/RKI, grants from Deutsche Forschungsgemeinschaft/German Research Society, and grants from Drägerwerk AG & Co. KGaA; in addition, Dr. Spies has a patent 10 2014 215 211.9 licensed, a patent 10 2018 114 364.8 licensed, a patent 10 2018 110 275.5 licensed, a patent 50 2015 010 534.8 licensed, a patent 50 2015 010 347.7 licensed, and a patent 10 2014 215 212.7 licensed., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.)

Background: Some patients with neuralgia of cranial nerves with otherwise therapy-refractory pain respond to invasive therapy with local anesthetics. Unfortunately, pain regularly relapses despite multimodal pain management. Transcranial direct current stimulation (tDCS) may prolong pain response due to neuro-modulatory effects., Methods: This controlled clinical pilot trial randomized patients to receive anodal, cathodal or sham-tDCS stimulation prior to local anesthetic infiltration. Pain attenuation, quality-of-life and side effects were assessed and compared with historic controls to estimate effects of tDCS stimulation setting., Results: Altogether, 17 patients were randomized into three groups with different stimulation protocols. Relative reduction of pain intensity in per protocol treated patients were median 73%, 50% and 69% in anodal, cathodal and sham group, respectively ( p = 0.726). Compared with a historic control group, a lower rate of responders with 50% reduction of pain intensity indicates probable placebo effects (OR 3.41 stimulation vs. non-stimulation setting, NNT 3.63). 76.9% ( n = 10) of tDCS patients reported mild side-effects. Of all initially included 17 patients, 23.5% ( n = 4) withdrew their study participation with highest proportion in the cathodal group ( n = 3). A sample size calculation for a confirmatory trial revealed 120 patients using conservative estimations., Discussion: This pilot trial does not support series of anodal tDCS as neuro-modulatory treatment to enhance pain alleviation of local anesthetic infiltration series. Notably, results may indicate placebo effects of tDCS settings. Feasibility of studies in this population was limited due to relevant drop-out rates. Anodal tDCS warrants further confirmation as neuro-modulatory pain treatment option., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Wandrey, Kastelik, Fritzsche, Denke, Schäfer and Tafelski.)

Purpose: Supporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany., Methods: We conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447)., Results: Between September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection management" (OR 4.397, 1.482-13.037), "enteral nutrition" (OR 1.579, 1.032-2.416), "patient and family communication" (OR 6.787, 3.976-11.589), and "early mobilisation" (OR 3.161, 2.160-4.624). No evidence for a difference in adherence to "daily multi-professional and interdisciplinary clinical visits" between both conditions was found (OR 1.606, 0.780-3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition)., Conclusion: A telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems., (© 2023. The Author(s).)

Based on shared experiences and values, the patient and their families form a relational unit. This social unity is especially valid in the situation of illness. Patients' relatives in intensive care units experience an exceptional emotional situation, associated with uncertainty, feelings of being overwhelmed, fear, and the desire for the best possible medical care. The principles of family-centered intensive care offer orientation and relief not only for the patients and their relatives, but also for the interprofessional team. Related measures, such as open visiting hours, appreciative communication, interprofessional team structures, and internal hospital standards can support all those involved in shaping and overcoming this critical situation together., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Every medical decision is based on balancing medical knowledge, ethical considerations, and patient preferences. Previous surveys have mainly covered the ethical knowledge of medical staff. The aim of this study is to evaluate the feasibility of an innovative concept regarding how ethical criteria are applied to clinical decision-making during critical illness., Methods: An online survey including a short case vignette was carried out at a university hospital among physicians specialising in intensive care medicine in Germany. After free text responses regarding further required case information, the participants were asked to rank decision criteria during the course of the case vignette. A qualitative evaluation was performed by two independent investigators, based on a transcription into categories. This was followed by a quantitative analysis of ranked criteria., Results: Our analysis has shown that doctors are initially inclined to consider medical information when making treatment decisions. When complications occur, ethical values are more often included in the decision-making. The qualitative evaluation reveiled that the patient's will was consistently regarded as the leading criterion for decision-making. In the quantitative evaluation, patient's well-being, quality of life, and patient autonomy were rated as the most important decision criteria. Economic factors were ranked least important., Conclusion: A mixed methods approach is able to reflect the complexity of ethical reasoning within the medical decision-making process, suggesting the feasibility of this concept., Clinical Trial Registration: The study was registered under DRKS-ID: DKRS00011905 (April 2017)., (© 2022 The Authors.)

Background: The pressure on physicians when a patient seeks pain relief and their own desire to be self-effective may lead to the prescription of strong opioids for chronic noncancer pain (CNCP). This study, via physician self-reporting, aims to identify and measure (i) physician adherence to national opioid prescribing guidelines and (ii) physician emotions when a patient seeks a dosage increase of the opioid. Methods: Within a cross-sectional survey—conducted as part of a randomized controlled online intervention trial (ERONA)—600 German physicians were queried on their opioid prescribing behavior (choice and formulation of opioid, indications) for CNCP patients and their emotions to a case vignette describing a patient seeking an opioid dosage increase without signs of objective deterioration. Results: The prescription of strong opioids in this study was not always in accordance with current guidelines. When presented with a scenario in which a patient sought to have their opioid dose increased, some physicians reported negative feelings, such as either pressure (25%), helplessness (25%), anger (23%) or a combination. The risk of non-guideline-compliant prescribing behavior using the example of ultrafast-acting fentanyl for CNCP was increased when negative emotions were present (OR: 1.7; 95%-CI: 1.2−2.6; p = 0.007) or when sublingual buprenorphine was prescribed (OR: 15.4; 95%-CI: 10.1−23.3; p < 0.001). Conclusions: Physicians’ emotional self-awareness represents the first step to identify such direct reactions to patient requests and to ensure a responsible, guideline-based opioid prescription approach for the long-term well-being of the patient.

Hundreds of thousands of individuals who experience lasting sequelae after sepsis and infections in Germany do not receive optimal care. In this White Paper we present measures for improvement, which were developed by a multidisciplinary expect panel as part of the SEPFROK project. Improved care rests on four pillars: 1. cross-sectoral assessment of sequelae and a structured discharge and transition management, 2. interdisciplinary rehabilitation and aftercare with structural support, 3. strengthening the specific health literacy of patients and families, and 4. increased research into causes, prevention and treatment of sequelae. To achieve this, appropriate cross-sectoral care structures and legal frameworks must be created., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: Strong opioids can have unintended effects. Clinical studies of strong opioids mainly report physical side effects, psychiatric or opioid use disorders. To date, too little attention has been paid to the psychological effects of opioids to treat patients with chronic noncancer pain (CNCP). This study aims to identify and measure (i) the nature and frequency of physical and psychological effects and (ii) the degree of physician counseling of patients with CNCP taking strong opioids., Methods: Within a cross-sectional survey-conducted as part of a randomised controlled online intervention trial (ERONA [Experiencing the risk of overusing opioids among patients with chronic non-cancer pain in ambulatory care])-300 German CNCP patients were surveyed via patient-reported outcome measures regarding on both the side effects from their use of strong opioids as well as their counselling experience., Results: Among the patients' reported effects, the psychological outcomes of the opioids in CNCP were: feeling relaxed (84%), fatigue (76%), dizziness (57%), listlessness (37%), difficulty with mental activities (23%), dulled emotions (17%) and poor memory (17%). Ninety-two per cent of the patients reported having received information about opioid effects, and 46% had discussed cessation of the opioid medication with their physicians before commencing the prescription., Conclusions: In addition to the well-known physical side effects, patients with CNCP taking strong opioids experience significant psychological effects. In view of these effects, discontinuation of opioid therapy should be discussed early to ensure their benefits do not outweigh their harm., Significance: In this study, patients with non-cancer pain notice that opioids they have taken do not only cause physical side effects but also may have an impact on their psyche and their emotions and, thus, may also affect quality of life substantially. Clinical trial number: DRKS00020358., (© 2021 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC ®.)

Background and Objectives: In 2012, the umbrella term post-intensive care syndrome (PICS) was introduced to capture functional long-term impairments of survivors of critical illness. We present a bibliometric network analysis of the PICS research field. Materials and Methods: The Web of Science core database was searched for articles published in 2012 or later using 'post-intensive care syndrome' and variant spellings. Using VOSviewer, we computed co-authorship networks of countries, institutions, and authors, as well as keyword co-occurrence networks. We determined each country's relative research effort and Category Normalized Citation Index over time and analyzed the 100 most-cited articles with respect to article type, country of origin, and publishing journal. Results: Our search yielded 379 articles, of which 373 were analyzed. Annual PICS research output increased from 11 (2012) to 95 articles (2020). Most PICS research originates from the US, followed by England, Australia, the Netherlands, and Germany. We found various collaborations between countries, institutions, and authors, with recent collaborative networks of English and Australian institutions. Article keywords cover aspects of cognitive, mental health, and physical impairments, and more recently, COVID-19. Only a few keywords and articles pertained to PICS prevention and treatment. Conclusions: Our analysis of Web of Science-indexed PICS articles highlights the stark increase in PICS research output in recent years, primarily originating from US- and Europe-based authors and institutions. Despite the research field's growth, knowledge gaps with respect to PICS prevention and treatment remain.

Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht.

The aim of this study was to synthesize quantitative research that identified ranking lists of the most severe stressors of patients in the intensive care unit, as perceived by patients, relatives, and health care professionals (HCP). We conducted a systematic literature search in PubMed, MEDLINE, EMBASE, PsycInfo, CINAHL, and Cochrane Library from 1989 to 15 May 2020. Data were analyzed with descriptive and semi-quantitative methods to yield summarizing ranking lists of the most severe stressors. We synthesized the results of 42 prospective cross-sectional observational studies from different international regions. All investigations had assessed patient ratings. Thirteen studies also measured HCP ratings, and four studies included ratings of relatives. Data indicated that patients rate the severity of stressors lower than HCPs and relatives do. Out of all ranking lists, we extracted 137 stressor items that were most frequently ranked among the most severe stressors. After allocation to four domains, a group of clinical ICU experts sorted these stressors with good to excellent agreement according to their stress levels. Our results may contribute to improve HCPs' and relatives' understanding of patients' perceptions of stressors in the ICU. The synthesized stressor rankings can be used for the development of new assessment instruments of stressors.

Background: There is no consensus on the instruments for diagnosis of post-intensive care syndrome (PICS). We present a proposal for a set of outcome measurement instruments of PICS in outpatient care., Methods: We conducted a three-round, semi-structured consensus-seeking process with medical experts, followed each by exploratory feasibility investigations with intensive care unit survivors (n 1  = 5; n 2  = 5; n 3  = 7). Fourteen participants from nine stakeholder groups participated in the first and second consensus meeting. In the third consensus meeting, a core group of six clinical researchers refined the final outcome measurement instrument set proposal., Results: We suggest an outcome measurement instrument set used in a two-step process. First step: Screening with brief tests covering PICS domains of (1) mental health (Patient Health Questionnaire-4 (PHQ-4)), (2) cognition (MiniCog, Animal Naming), (3) physical function (Timed Up-and-Go (TUG), handgrip strength), and (4) health-related quality of life (HRQoL) (EQ-5D-5L). Single items measure subjective health before and after the intensive care unit stay. If patients report new or worsened health problems after intensive care unit discharge and show relevant impairment in at least one of the screening tests, a second extended assessment follows: (1) Mental health (Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder Scale-7 (GAD-7), Impact of Event Scale - revised (IES-R)); (2) cognition (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test (TMT) A and B); (3) physical function (2-Minute Walk Test (2-MWT), handgrip strength, Short Physical Performance Battery (SPPB)); and (4) HRQoL (EQ-5D-5L, 12-Item WHO Disability Assessment Schedule (WHODAS 2.0))., Conclusions: We propose an outcome measurement instrument set used in a two-step measurement of PICS, combining performance-based and patient-reported outcome measures. First-step screening is brief, free-of-charge, and easily applicable by health care professionals across different sectors. If indicated, specialized healthcare providers can perform the extended, second-step assessment. Usage of the first-step screening of our suggested outcome measurement instrument set in outpatient clinics with subsequent transfer to specialists is recommended for all intensive care unit survivors. This may increase awareness and reduce the burden of PICS., Trial Registration: This study was registered at ClinicalTrials.gov (Identifier: NCT04175236; first posted 22 November 2019)., Competing Interests: Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: CDS reports grants from Gemeinsamer Bundesausschuss (G-BA)/Federal Joint Committee, during the conduct of the study; grants from Aridis Pharmaceutical Inc., grants from B Braun Melsungen AG, grants from Drägerwerk AG & Co KGaA, grants from Grünenthal GmbH, grants from Infectopharm GmbH, grants from Sedana Medical Ltd, grants from Deutsche Forschungsgemeinschaft/German Research Society, grants from Deutsches Zentrum für Luft- und Raumfahrt e.V. (DLR)/German Aerospace Center, grants from Einstein Stiftung Berlin/Einstein Foundation Berlin, grants from the European Society of Anaesthesiology, grants from Gemeinsamer Bundesausschuss (G-BA)/Federal Joint Committee, grants from Inneruniversitäre Forschungsförderung/Inner University Grants, grants from Projektträger im DLR/Project Management Agency, grants from Stifterverband/Non-Profit Society Promoting Science and Education, grants from WHOCC, grants from Baxter Deutschland GmbH, grants from Biotest AG, grants from Cytosorbents Europe GmbH, grants from Edwards Lifesciences Germany GmbH, grants from Fresenius Medical Care, grants from Grünenthal GmbH, grants from Masimo Europe Ltd, grants from Medtronic GmbH, grants from Pfizer Pharma PFE GmbH, personal fees from Georg Thieme Verlag, grants from Dr. F. Köhler Chemie GmbH, grants from Sintetica GmbH, grants from the European Commission, grants from Stifterverband für die Deutsche Wissenschaft e.V./Philips, grants from Stiftung Charité, outside the submitted work; in addition, CDS has a patent 10 2014 215 211.9 pending, a patent Application No. PCT/EP2015/067730 pending to Graft Gesellschaft von Architekten mbH, and a patent Application No. PCT/EP2015/067731 pending to Graft Gesellschaft von Architekten mbH. HK, NP, TG, SR, JJG, KSc, KSt, JC, JKr, JKi, CD, SP, CA, RB, UM, SWC and MG declare that there is no conflict of interest. CH reports grants to her institution from the German Federal Ministry of Education and Research (BMBF) via the Center for Sepsis Control and Care Jena, the German Innovations Funds/Federal Joint Committee, and the European Society of Intensive Care Medicine. BW reports personal fees from Orion Pharma Ltd. and personal fees from Dr. F. Köhler Chemie GmbH, outside the submitted work., (© The Intensive Care Society 2020.)

Empathy influences how we perceive, understand, and interact with our social environment. Previous studies suggested a network of different brain regions as a neural substrate for empathy, including, in particular, insula and anterior cingulate cortex (ACC). In addition, a contribution of the somatosensory cortices for this empathy related network has been suggested. This is remarkable, given that other recent studies have revealed a role for the somatosensory cortex in various social tasks. For example, in experiments using tactile priming, incidental haptic sensations are found to influence judgment recommendations. Here, we aimed to test if this engagement of the somatosensory cortices during tactile priming can be predicted by the participant's empathy personality traits. We assessed participant's empathy and personality traits by means of the Interpersonal Reactivity Index (IRI) and NEO-FFI and tested whether trait empathy is associated with the tactile priming effect in social judgments. Results revealed that empathy predicted the tactile priming effect negatively. This was accompanied by a reduced engagement of the somatosensory cortex, which has been shown to be associated with the priming effect. We conclude that empathy seems to protect people from tactile priming effects., (Copyright © 2020 Schaefer, Cherkasskiy, Denke, Spies, Song, Malahy, Heinz, Ströhle, Schäfer, Mianroudi and Bargh.)

The number of patients who survive sepsis is growing. However, two of three sepsis survivors suffer from new physical or mental sequelae. Cognitive deficits, depression or limitations of the activities of daily living can seriously impair quality of life and working ability. Sepsis sequelae cover a range of lesions; current rehabilitation therapies appear unsuited because they are focused on only one organ system. An interdisciplinary approach is necessary to evaluate and treat sepsis sequelae. Survivors and their relatives should be informed about sepsis and possible sequelae as early as possible. Further studies are needed to improve the understanding of pathomechanisms and effectivity of treatment interventions for sepsis sequelae., Competing Interests: Christiane Hartog gibt Förderungen durch das Bundesministerium für Bildung und Forschung (BMBF), den Innovationsfonds des Gemeinsamen Bundesausschusses (G-BA) und die European Society of Intensive Care Medicine an. Carolin Fleischmann-Struzek erhält Förderungen durch das BMBF und den Innovationsfonds des G-BA und gibt eine Beratertätigkeit bei der WHO an. Björn Weiss gibt Honorare für Beratertätigkeiten bzw. Vorträge von Orion Pharma Ltd. bzw. Dr. F. Köhler Chemie an. Konrad Reinhart erhält Förderung durch das BMBF, den Innovationsfonds des G-BA und die Stiftung Charité. Claudia Denke und Ulf Bodechtel geben an, dass keine Interessenkonflikte vorliegen., (© Georg Thieme Verlag KG Stuttgart · New York.)

Test anxiety is a condition in which people experience extreme distress and anxiety before and in test situations. It affects up to 40 percent of all students. Conventional treatment includes both medication and psychotherapy, but studies also demonstrated that placebos affect anxiety symptoms. Although in the traditional understanding placebos need to be administered in a concealed way, intriguing new studies report that open-label placebos can be effective. Since prescription of fake pills involves ethical problems, open-label placebos may provide important new treatment possibilities. Here we report results of a pilot study examining whether open-label placebos may reduce test anxiety and improve self-management skills. 58 students participated in a two-group randomized controlled trial. Two weeks before an exam at the university participants received open-label placebos or no pills (control group). Participant - provider relationship and amount of contact time was held similar for all groups. After two weeks we found that test anxiety and self-management abilities (skills and resources) of the open-label placebo group were more improved than in the control group. Thus, our results seems to indicate that open-label placebos may reduce test anxiety and enhance self-management skills in students.

Background: Communication with relatives is a central part of the decision-making process. In the absence of the patient's direct consent to a potential organ donation, the next of kin must provide information about a potential wish to donate and give permission in the context of an extended consent solution. At the same time, family members must also cope with the death of a loved one., Objective: To determine how relatives can be optimally supported during the decision-making process., Materials and Methods: Narrative review., Results: In the context of potential or confirmed irreversible brain death, communication with family members or legal representatives serves to deliver bad news as well as to determine whether the patient had a wish to donate his/her organs and to clarify the resultant steps. Communication strategies such as the SPIKES or VALUE models provide emotional and cognitive support for relatives and strengthen clinicians' communication skills. Clinicians' behavior towards patients, deceased, and next of kin may influence relatives' decision-making; respectful and competent behavior seems to contribute towards relatives granting permission for organ donation., Conclusion: Clinicians must be trained and skilled in communication strategies which are used in critical situations to provide emotional support to relatives during the organ donation decision-making process. Relatives are more likely to achieve a satisfying and sustainable decision if a strong relationship exists between clinicians and relatives based on information giving, openness, trust, and empathy.

Objective Delirium in critically ill patients is considered a risk factor for various long-term consequences. We evaluated delirium and associated long-term outcomes in patients with acute respiratory distress syndrome with non-H1N1 and H1N1- associated severe community-acquired pneumonia (sCAP) who had been recommended to take antiviral drugs associated with delirious symptoms as adverse effects. Methods Of 64 patients, 42 survivors (H1N1, 15; non-H1N1, 27) were analyzed regarding the relationship between medication and the duration of delirium in the intensive care unit. During follow-up (n = 23), we assessed cognitive abilities, post-traumatic stress disorder (PTSD), physical capacity, and health-related quality of life (HRQoL). Results The incidence of delirium was 88%. There was no difference in the incidence and duration of delirium between patients with H1N1 and non-H1N1 infection. The haloperidol and opioid doses were associated with a longer delirium duration. The delirium duration was correlated with reduced cognitive performance in motor skills, memory function, and learning efficiency. Patients with PTSD (16%) had a significantly longer delirium duration and low mental HRQoL. Conclusions H1N1 infection and corresponding antiviral medication had no impact on delirium. The duration of delirium in these patients was associated with impairments in various outcome parameters, illustrating the burden of sCAP.

Extralegal factors may influence judicial outcomes. Here we investigated the experience of incidental haptic sensations on the harshness of punishment recommendations. Based on recent theories of embodiment, which claim that cognitive representations are structured by metaphorical mappings from sensory experience, we hypothesized that tactile priming with hard objects would cause subjects to recommend harsher sentences (to be 'hard on crime'). Furthermore, the theory of embodiment predicts that this effect should be based on sensorimotor brain activation during the judging process. In order to test this we presented participants with scenarios that described various crimes while scanning their brain activity with fMRI. Participants were then asked to rate how severely they would sentence the delinquents. Before the scenarios, the participants were primed by touching either a hard or a soft object. Results revealed tha t hard priming led participants to recommend harder punishments. These results were accompanied by activation of somatosensory brain areas during the judging phase. This outcome is in line with simulation assumptions of the embodiment theory and proposes a central role of the sensorimotor cortices for embodied metaphors. Thus, incidental tactile experiences can influence our abstract cognitions and even how hard we are on criminals.

The alien hand syndrome (AHS) is a fascinating movement disorder. Patients with AHS experience one of their limbs as alien, which acts autonomously and performs meaningful movements without being guided by the intention of the patient. Here, we report a case of a 74-years old lady diagnosed with an atypical Parkinson syndrome by possible corticobasal degeneration. The patient stated that she could not control her right hand and that she felt like this hand had her own life. We tested the patient for ownership illusions of the hands and general tactile processing. Results revealed that when blindfolded, the patient recognized touch to her alien hand only if it was presented separated from touch to the other hand (bilateral asynchronous touch). Delivering touch synchronously to both the alien and the healthy hand resulted in failure of recognizing touch to the alien hand (bilateral synchronous touch). Thus, AHS here co-existed with right-sided tactile extinction and is one of only very few cases in which the alien hand was felt on the right side. We discuss the results in the light of recent research on AHS.

It is well known from literature and religious ceremonies that there is a link between physical cleansing and moral transgressions. Only recently, psychological experiments explored this association and demonstrated that a threat to moral purity increases the demand of physical cleansing. Moreover, it has been shown that physical cleansing is actually efficacious to cope with threatened morality. This so-called Macbeth effect has been explained by an embodiment of the moral-purity metaphor. We tested this hypothesis by means of an functional magnetic resonsce imaging (fMRI) experiment. Participants were instructed to enact scenarios including either an immoral act (lying) or a moral deed (telling the truth). Subsequently, the participants were asked to rate the desirableness of various products. Results revealed that participants rated cleansing products (but not other goods) more desirable after performing an immoral than after a moral act. This Macbeth effect was accompanied by an active cortical network including sensorimotor brain areas during rating of cleansing products (but not while evaluating noncleansing goods). The results demonstrate neurobiological evidence for an embodiment of the moral-purity metaphor. Thus, abstract thoughts about morality can be grounded in sensory experiences., (© The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

The theory of embodied cognition claims that knowledge is represented in modal systems derived from perception. Recent behavioral studies found evidence for this hypothesis, for example, by linking moral purity with physical cleansing (the Macbeth effect). Neurophysiological approaches provided further support by showing an involvement of sensorimotor cortices for embodied metaphors. However, the exact role of this brain region for embodied cognitions remains to be cleared. Here we demonstrate that the involvement of the sensorimotor cortex for the embodied metaphor of moral-purity is somatotopically organized. Participants enacted in scenarios where they had to perform immoral or moral acts either with their mouths or their hands. Results showed that mouthwash products were particularly desirable after lying in a voice mail and hand wash products were particularly desirable after writing a lie, thus demonstrating that the moral-purity metaphor is specific to the sensorimotor modality involved in earlier immoral behavior. FMRI results of this interaction showed activation in sensorimotor cortices during the evaluation phase that was somatotopically organized with respect to preceding lying in a voice mail (mouth-area) or in a written note (hand-area). Thus, the results provide evidence for a central role of the sensorimotor cortices for embodied metaphors.

Constipation is a prevalent comorbidity affecting ∼50% of patients with long-term opioid therapy. In clinical routine different diagnostic instruments are in use to identify patients under risk. The aim of this study was to assess the diagnostic performance of an 11-item Likert scale for constipation used as a self-assessment in opioid-treated patients. This trial was conducted as a retrospective cohort study in Berlin, Germany. Patients with long-term opioid therapy treated in 2 university-affiliated outpatient pain facilities at the Charité hospital were included from January 2013 to August 2013. Constipation was rated in a self-assessment using a numeric rating scale from 0 to 10 (Con-NRS) and compared with results from a structured assessment based on ROME-III criteria. Altogether, 171 patients were included. Incidence of constipation was 49% of patients. The receiver-operating characteristic of Con-NRS achieved an area under the curve of 0.814 (AUC 95% confidence interval 0.748-0.880, P < 0.001). Con-NRS ≥ 1 achieved sensitivity and specificity of 79.7% and 77.2%, respectively. The positive predictive value and the negative predictive value were 70.3% and 81.6%, respectively. Overall diagnostic performance of a concise 11-item Likert scale for constipation was moderate. Although patients with long-term opioid therapy are familiar with numeric rating scales, a significant number of patients with constipation were not identified. The instrument may be additionally useful to facilitate individualized therapeutic decision making and to control therapeutic success when measured repetitively., Competing Interests: The authors have no conflicts of interest to disclose.

Numerous studies explore consumer perception of brands in a more or less passive way. This may still be representative for many situations or decisions we make each day. Nevertheless, sometimes we often actively search for and use information to make informed and reasoned choices, thus implying a rational and thinking consumer. Researchers suggested describing this distinction as low relative to high involvement consumer behavior. Although the involvement concept has been widely used to explain consumer behavior, behavioral and neural correlates of this concept are poorly understood. The current study aims to describe a behavioral measure that is associated with high involvement, the length of search behavior. A second aim of this study was to explore brain activations associated with involvement by employing functional magnetic resonance imaging (fMRI). We presented participants information cues for different products and told them that they had to answer questions with respect to these products at the end of the experiment. Participants were free to stop the information search if they think they gathered enough information or to continue with collecting information. Behavioral results confirmed our hypothesis of a relationship between searching behavior and personal involvement by demonstrating that the length of search correlated significantly with the degree of personal involvement of the participants. fMRI data revealed that personal involvement was associated with activation in BA44. Since this brain region is known to be involved in semantic memory, the results of this pilot study suggest that high involvement consumer behavior may be linked to cognitive load and attention towards a product.

Definitions and difficulties relating to managing acute and chronic pain in patients with current or past substance abuse disorders are discussed. Problems with too rapid discontinuation of drugs are described. An interdisciplinary approach involving pain specialists, substance abuse clinicians and mental health professional is advocated.