Determinants of Subjective Mental and Functional Health of Critical Illness Survivors: Comparing Pre-ICU and Post-ICU Status.

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.

[Psychosocial Care in the Intensive Care Unit]. / Psychosoziale Betreuung auf der Intensivstation.

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.

A brief questionnaire for measuring alarm fatigue in nurses and physicians in intensive care units.

When exposed to hundreds of medical device alarms per day, intensive care unit (ICU) staff can develop "alarm fatigue" (i.e., desensitisation to alarms). However, no standardised way of quantifying alarm fatigue exists. We aimed to develop a brief questionnaire for measuring alarm fatigue in nurses and physicians. After developing a list of initial items based on a literature review, we conducted 15 cognitive interviews with the target group (13 nurses and two physicians) to ensure that the items are face valid and comprehensible. We then asked 32 experts on alarm fatigue to judge whether the items are suited for measuring alarm fatigue. The resulting 27 items were sent to nurses and physicians from 15 ICUs of a large German hospital. We used exploratory factor analysis to further reduce the number of items and to identify scales. A total of 585 submissions from 707 participants could be analysed (of which 14% were physicians and 64% were nurses). The simple structure of a two-factor model was achieved within three rounds. The final questionnaire (called Charité Alarm Fatigue Questionnaire; CAFQa) consists of nine items along two scales (i.e., the "alarm stress scale" and the "alarm coping scale"). The CAFQa is a brief questionnaire that allows clinical alarm researchers to quantify the alarm fatigue of nurses and physicians. It should not take more than five minutes to administer.

Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial.

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.

Subjective Ratings of Mental and Physical Health Correlate With EQ-5D-5L Index Values in Survivors of Critical Illness: A Construct Validity Study.

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.

Emotion regulation moderates the association between COVID-19 stress and mental distress: findings on buffering, exacerbation, and gender differences in a cross-sectional study from Norway.

Background: Maintaining good mental health is important during a crisis. However, little attention has been given to how people achieve this, or how they evaluate emotions associated with stressors, such as the COVID-19 pandemic. This study aims to (1) investigate whether emotion regulation, in particular cognitive reappraisal and suppression, moderates the relationship between COVID-19 stress and general mental distress and (2) examine gender differences in the interrelations between COVID-19 stress, emotion regulation, and mental distress. Methods: Data from a population in Norway (n = 1.225) were collected using a cross-sectional survey during the early months of the COVID-19 pandemic. Emotion regulation was measured using the Emotion Regulation Questionnaire Scale (ERQ), COVID-19 stress with the COVID-19 Stress Scale, and mental distress with the Patient Health Questionnaire 4 (PHQ-4). Moderation analyses were conducted using the PROCESS macro for SPSS. Results: There was a strong association between COVID-19 stress and general mental distress (r = 0.61). The moderation analyses showed substantial moderation effects of cognitive reappraisal and suppression on the relationship between COVID-19 stress and mental distress. Cognitive reappraisal served as a buffer (p = 0.001) and suppression (p = 0.002) exacerbated the relation between COVID-19 stress and mental distress. Men had higher scores of suppression (p < 0.001), and women had higher scores of cognitive reappraisal (p = 0.025). The buffering effect of cognitive reappraisal presented itself only in women (p < 0.001), while the exacerbation effect of suppression appeared only in men (p < 0.001). Conclusion: The current study suggests that COVID-19 pandemic-related stress is easier to deal with for those who have the tendency to cognitively reappraise. In contrast, suppression is associated with symptoms of depression and anxiety. The prevention of mental distress can be supported by guiding people about the importance of using healthy emotion regulation strategies, as well as helping them to become more aware of the way they interpret and regulate their emotions. Gender differences in emotion regulation suggest gender awareness, e.g., tailored programs for men and women.

Meaningfulness protects from and crisis of meaning exacerbates general mental distress longitudinally.

BACKGROUND: Reactions to the COVID-19 pandemic are diverse, and both mental distress and existential crises can arise. The identification of protective and exacerbating factors and their progress over time is therefore highly relevant. The current study examined longitudinal protective effects of meaningfulness and exacerbating effects of crisis of meaning on general mental distress. METHODS: N = 431 participants from Germany and Austria (mean age: 42 years) completed an online survey in both April/May (T1) and July/August 2020 (T2). After determining temporal stability or changes in meaningfulness, crisis of meaning, and general mental distress (PHQ-4), we examined whether (i) meaningfulness and (ii) crisis of meaning, measured at T1, incrementally predicted PHQ-4 at T2, beyond baseline levels of PHQ-4. We further tested (iii) a within-subject mediation of temporal changes in PHQ-4 by changes in crisis of meaning. RESULTS: Meaningfulness prospectively predicted lower PHQ-4, and crisis of meaning predicted higher PHQ-4. From the first wave of the pandemic until a slowdown three months later, meaningfulness was stable, and crisis of meaning and PHQ-4 decreased. Changes in crisis of meaning mediated the changes in PHQ-4. CONCLUSIONS: Meaningfulness appears to have a protective, and crisis of meaning an exacerbating effect on psychological distress, as shown here for the time of the first pandemic wave until three months later. Attention to existential experiences of meaningfulness and loss of meaning thus proves relevant to the clinical and public health context. Measures that support meaningfulness will help coping with crises of meaning, which in turn supports overcoming general mental distress.

Creation of an Evidence-Based Implementation Framework for Digital Health Technology in the Intensive Care Unit: Qualitative Study.

BACKGROUND: Digital health technologies such as continuous remote monitoring and artificial intelligence-driven clinical decision support systems could improve clinical outcomes in intensive care medicine. However, comprehensive evidence and guidelines for the successful implementation of digital health technologies into specific clinical settings such as the intensive care unit (ICU) are scarce. We evaluated the implementation of a remote patient monitoring platform and derived a framework proposal for the implementation of digital health technology in an ICU. OBJECTIVE: This study aims to investigate barriers and facilitators to the implementation of a remote patient monitoring technology and to develop a proposal for an implementation framework for digital health technology in the ICU. METHODS: This study was conducted from May 2018 to March 2020 during the implementation of a tablet computer-based remote patient monitoring system. The system was installed in the ICU of a large German university hospital as a supplementary monitoring device. Following a hybrid qualitative approach with inductive and deductive elements, we used the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change to analyze the transcripts of 7 semistructured interviews with clinical ICU stakeholders and descriptive questionnaire data. The results of the qualitative analysis, together with the findings from informal meetings, field observations, and previous explorations, provided the basis for the derivation of the proposed framework. RESULTS: This study revealed an insufficient implementation process due to lack of staff engagement and few perceived benefits from the novel solution. Further implementation barriers were the high staff presence and monitoring coverage in the ICU. The implementation framework includes strategies to be applied before and during implementation, targeting the implementation setting by involving all ICU stakeholders, assessing the intervention's adaptability, facilitating the implementation process, and maintaining a vital feedback culture. Setting up a unit responsible for implementation, considering the guidance of an implementation advisor, and building on existing institutional capacities could improve the institutional context of implementation projects in the ICU. CONCLUSIONS: Implementation of digital health in the ICU should involve a thorough preimplementation assessment of the ICU's need for innovation and its readiness to change, as well as an ongoing evaluation of the implementation conditions. Involvement of all stakeholders, transparent communication, and continuous feedback in an equal atmosphere are essential, but leadership roles must be clearly defined and competently filled. Our proposed framework may guide health care providers with concrete, evidence-based, and step-by-step recommendations for implementation practice, facilitating the introduction of digital health in intensive care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03514173; https://clinicaltrials.gov/ct2/show/NCT03514173.

Living with Chronic Pain During the COVID-19 Pandemic: A Qualitative Analysis.

Purpose: 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.

A Decade of Post-Intensive Care Syndrome: A Bibliometric Network Analysis.

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.

Presentation of ethical criteria during medical decision-making for critically ill patients: a mixed methods study.

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).

Compliance with COVID-19 public health guidelines: an attitude-behaviour gap bridged by personal concern and distance to conspiracy ideation.

OBJECTIVE: This study examined predictors of compliance with public health guidelines to curb transmission of COVID-19. DESIGN: Applying an exploratory longitudinal design, participants (N = 431) from Germany and Austria completed surveys in April/May 2020 (T1) and July/August 2020 (T2). MEASURES: Three outcome measures operationalised compliance with public health guidelines at T2: self-reported adherence (behavioural), agreement and opposition (attitudinal). At T1, demographics, perceived distress (PHQ-4, crisis of meaning), resources (self-control, meaningfulness), locus of control, conspiracy mentality and social media use were assessed. At T2, situational variables were added (person at risk, infection of close person, fear of infection, COVID-19 stress). Temporal shifts from T1 to T2 were examined as complementary information. RESULTS: An attitude-behaviour gap at T2 was identified, as agreement with and opposition to the guidelines were only modestly correlated with adherence to them. Measures of personal concern (fear of infection, person at risk) were associated with both adherence and positive attitudes towards the measures. COVID-19 stress and conspiracy mentality predicted negative attitudes, but not adherence. Age predicted adherence positively, social media use negatively. CONCLUSION: The findings support the significance of personal concern for compliance with public health guidelines and suggest a critical impact of social media use and conspiracy mentality.

Perceived Severity of Stressors in the Intensive Care Unit: A Systematic Review and Semi-Quantitative Analysis of the Literature on the Perspectives of Patients, Health Care Providers and Relatives.

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.

Locus of control moderates the association of COVID-19 stress and general mental distress: results of a Norwegian and a German-speaking cross-sectional survey.

BACKGROUND: An internal locus of control (LoC I) refers to the belief that the outcome of events in one's life is contingent upon one's actions, whereas an external locus of control (LoC E) describes the belief that chance and powerful others control one's life. This study investigated whether LoC I and LoC E moderated the relationship between COVID-19 stress and general mental distress in the general population during the early months of the COVID-19 pandemic. METHODS: This cross-sectional survey study analysed data from a Norwegian (n = 1225) and a German-speaking sample (n = 1527). We measured LoC with the Locus of Control-4 Scale (IE-4), COVID-19 stress with a scale developed for this purpose, and mental distress with the Patient Health Questionnaire 4 (PHQ-4). Moderation analyses were conducted using the PROCESS macro for SPSS. RESULTS: The association between COVID-19 stress and general mental distress was strong (r = .61 and r = .55 for the Norwegian and the German-speaking sample, respectively). In both samples, LoC showed substantial moderation effects. LoC I served as a buffer (p < .001), and LoC E exacerbated (p < .001) the relation between COVID-19 stress and general mental distress. CONCLUSIONS: The data suggest that the COVID-19 pandemic is easier to bear for people who, despite pandemic-related strains, feel that they generally have influence over their own lives. An external locus of control, conversely, is associated with symptoms of depression and anxiety. The prevention of mental distress may be supported by enabling a sense of control through citizen participation in policy decisions and transparent explanation in their implementation.

Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings - Results of an expert consensus and feasibility field test.

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 (n1 = 5; n2 = 5; n3 = 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).

Cross-Sectional and Longitudinal Construct Validity of the Generic KINDL-A(dult)B(rief) Questionnaire in Adults with Thrombophilia or with Hereditary and Acquired Bleeding Disorders.

BACKGROUND/AIMS: The newly adapted generic KINDL-A(dult)B(rief) questionnaire showed satisfactory cross-sectional psychometric properties in adults with bleeding disorders or thrombophilia. This investigation aimed to evaluate its cross-sectional and longitudinal construct validity. METHODS: After ethical committee approval and written informed consent, 335 patients (mean age 51.8 ± 16.6 years, 60% women) with either predominant thrombophilia (n = 260) or predominant bleeding disorders (n = 75) participated. At baseline, patients answered the KINDL-AB, the MOS 36-item Short-Form Health Survey (SF-36), and the EQ-5D-3L. A subgroup of 117 patients repeated the questionnaire after a median follow-up of 2.6 years (range: 0.4-3.5). A priori hypotheses were evaluated regarding convergent correlations between KINDL-AB overall well-being and specific subscales, EQ-5D-3L index values (EQ-IV), EQ-5D visual analog scale (EQ-VAS), and SF-36 subscales. RESULTS: Contrary to hypothesis, baseline correlations between the KINDL-AB and EQ-IV/EQ-VAS were all moderate while, as hypothesized, several KINDL-AB subscales and SF-36 subscales correlated strongly. At follow-up, no significant changes in all three instruments occurred. Correlations between instruments over the follow-up were mostly moderate and partially strong. Contrary to hypothesis but consistent with no significant changes in health-related quality of life, convergent correlations between changes in KINDL-AB overall well-being, physical and psychological well-being, and EQ-IV/EQ-VAS were all weak. CONCLUSIONS: While repeated measures of KINDL-AB showed moderate to strong correlations, changes in KINDL-AB overall well-being and subscales correlated more weakly than expected with changes involving two established instruments of generic health status.

Sense of coherence, mental well-being and perceived preoperative hospital and surgery related stress in surgical patients with malignant, benign, and no neoplasms.

BACKGROUND: This prospective, cross-sectional, observational study examined associations between sense of coherence (SOC), mental well-being, and perceived preoperative hospital and surgery related stress of surgical patients with malignant, benign, and no neoplasms. The objective was to assess a putative association between SOC and preoperative stress, and to test for a statistical mediation by mental well-being. METHOD: The sample consisted of 4918 patients from diverse surgical fields, of which 945 had malignant neoplasms, 333 benign neoplasms, and 3640 no neoplasms. For each subsample, we conducted simple mediation analyses to test an indirect effect of SOC on preoperative stress mediated by mental well-being. The models were adjusted for age, gender, and essential medical factors. RESULTS: Patient groups did not differ significantly regarding degrees of SOC and mental well-being (SOC, M [SD]: 12.31 [2.59], 12.02 [2.62], 12.18 [2.57]; mental well-being M [SD]: 59.26 [24.05], 56.89 [22.67], 57.31 [22.87], in patients with malignant, benign, and without neoplasms, respectively). Patients without neoplasms reported significantly lower stress (4.19 [2.86], M [SD]) than those with benign (5.02 [3.03], M [SD]) and malignant neoplasms (4.99 [2.93], M [SD]). In all three mediation models, SOC had significant direct effects on stress, with higher SOC being associated with lower stress (- 0.3170 [0.0407], - 0.3484 [0.0752], - 0.2919 [0.0206]; c' [SE], p < 0.001 in patients with malignant, benign, and without neoplasms, respectively). In patients with malignant neoplasms and without neoplasms, SOC showed small indirect effects on stress that were statistically mediated by well-being. Higher SOC was related to higher well-being, which in turn was related to lower stress. In patients with benign neoplasms, however, no significant indirect effects of SOC were found. CONCLUSIONS: SOC was directly associated with lower perceived hospital and surgery related stress, over and above the direct and mediation effects of mental well-being. Because the data are cross-sectional, conclusions implying causality cannot be drawn. Nevertheless, they indicate important relationships that can inform treatment approaches to reduce elevated preoperative stress by specifically addressing low SOC. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01357694 . Registered 18 May 2011.

Meaning in Life and Self-Control Buffer Stress in Times of COVID-19: Moderating and Mediating Effects With Regard to Mental Distress.

BACKGROUND: As evidenced by several studies, mental distress increased substantially during the COVID-19 pandemic. In this period, citizens were asked to exercise a high degree of self-control with regard to personal and social health behavior. At the same time, we witnessed an increase of prosocial acts and shared creative expressions, which are known to serve as sources of meaning. Meaning in life and self-control are acknowledged psychological resources. Especially in times of crisis, meaning in life has been shown to be a crucial factor for resilience and coping. However, threatening and stressful situations can also jeopardize existential security and trigger crises of meaning. The present study aimed to document levels of acute COVID-19 stress and general mental distress in Germany and Austria during the lockdown and in the weeks thereafter. In order to identify potential risk factors related to demographics and living conditions, their associations with COVID-19 stress were analyzed exploratively. The primary objective of the study, however, was to investigate the buffering effect of two psychological resources-meaningfulness and self-control-with regard to the relation between acute COVID-19 stress and general mental distress. Finally, a potential aggravation of mental distress due to the occurrence of crises of meaning was examined. METHOD: A cross-sectional survey was conducted online during lockdown (survey group 1) and the subsequent weeks characterized by eased restrictions (survey group 2). A total of N = 1,538 German-speaking participants completed a questionnaire battery including a novel measure of acute COVID-19 stress, meaningfulness and crisis of meaning (SoMe), self-control (SCS-KD), and a screening of general mental distress, measured by core symptoms of depression and anxiety (PHQ-4). In a first step, associations between living conditions, demographics, and COVID-19 stress were explored. Second, a moderation and a mediation model were tested. Meaningfulness, a measure of presence of meaning in life, as well as self-control were proposed to serve as buffers in a time of crisis, thus moderating the relation between acute COVID-19 stress and general mental distress (double moderation). Crisis of meaning, operationalizing an experienced lack of meaning in life, was proposed to mediate the relationship between acute COVID-19 stress and general mental distress, with an assumed moderation of the association between COVID-19 stress and crisis of meaning by survey group (lockdown versus eased restrictions after lockdown), and a hypothesized moderation of the link between crisis of meaning and general mental distress by self-control (dual moderated mediation). RESULTS: COVID-19 stress was slightly right-skewed. Scores were higher during lockdown than in the weeks thereafter. The rate of clinically significant general mental distress was high, exceeding prevalence rates from both the general population and clinical samples of the time before the pandemic. In the weeks following the lockdown (group 2), general mental distress and crisis of meaning were significantly higher than during lockdown (group 1), whereas meaningfulness and self-control were significantly lower. Demographically, age had the strongest association with COVID-19 stress, with older participants perceiving less acute stress (r = -.21). People who were partnered or married suffered less from COVID-19 stress (η2 = .01). Living alone (η2 = .006), living in a room versus a flat or house (η2 = .008), and being unemployed due to the pandemic (η2 = .008) were related to higher experience of COVID-19 stress. COVID-19 stress and general mental distress were strongly related (r = .53). Both meaningfulness and self-control were negatively associated with general mental distress (r = -.40 and -.36, respectively). They also moderated the relationship between COVID-19 stress and general mental distress: When meaningfulness was high, high COVID-19 stress was related to substantially lower PHQ-4 scores than when meaningfulness was low. The same held for self-control: High scores of self-control were associated with lower PHQ-4 scores especially when COVID-19 stress was high. Crisis of meaning mediated the relationship between COVID-19 stress and PHQ-4. There was a higher likelihood of crises of meaning occurring when COVID-19 stress was high; crisis of meaning, in turn, was associated with general mental distress. Survey group moderated the first path of this mediation, i.e., the relationship between COVID-19 stress and crisis of meaning: High scores of COVID-19 stress were associated more strongly with crisis of meaning in the second survey group (after the lockdown). Self-control moderated the second path, i.e., the relationship between crisis of meaning and PHQ-4: When a crisis of meaning was present, self-control could buffer its effect on general mental distress. CONCLUSIONS: Also in the present study among German-speaking participants, general mental distress was high. Scores were higher after than during the lockdown, indicating an ongoing destabilization for a significant part of the population. People who saw a meaning in their lives and who were capable of self-control reported substantially less mental distress. Meaningfulness and self-control also served as buffers between COVID-19 stress and general mental distress: When COVID-19 stress was high, the presence of meaningfulness and self-control accounted for lower general mental distress. Moreover, people who suffered strongly from COVID-19 stress were more likely to develop a crisis of meaning which, in turn, was associated with higher general mental distress. This suggests that ongoing anxiety and depression might (also) be based on existential struggles. Again here, self-control buffered the impact of crisis of meaning on general mental health. We conclude from these findings that public health policies can support citizens in coping with large-scale crises by enabling experiences of meaningfulness, e.g., through transparent and reliable modes of communicating goals and necessary intermediate steps. Moreover, health professionals are well advised to invite individuals to confront existential questions and struggles, and to encourage them to exercise self-control. The latter can be boosted by keeping higher-order goals salient-which again is inherently linked to an understanding of their meaning.

Improvements in Patient Monitoring in the Intensive Care Unit: Survey Study.

BACKGROUND: Due to demographic change and, more recently, coronavirus disease (COVID-19), the importance of modern intensive care units (ICU) is becoming apparent. One of the key components of an ICU is the continuous monitoring of patients' vital parameters. However, existing advances in informatics, signal processing, or engineering that could alleviate the burden on ICUs have not yet been applied. This could be due to the lack of user involvement in research and development. OBJECTIVE: This study focused on the satisfaction of ICU staff with current patient monitoring and their suggestions for future improvements. We aimed to identify aspects of monitoring that interrupt patient care, display devices for remote monitoring, use cases for artificial intelligence (AI), and whether ICU staff members are willing to improve their digital literacy or contribute to the improvement of patient monitoring. We further aimed to identify differences in the responses of different professional groups. METHODS: This survey study was performed with ICU staff from 4 ICUs of a German university hospital between November 2019 and January 2020. We developed a web-based 36-item survey questionnaire, by analyzing a preceding qualitative interview study with ICU staff, about the clinical requirements of future patient monitoring. Statistical analyses of questionnaire results included median values with their bootstrapped 95% confidence intervals, and chi-square tests to compare the distributions of item responses of the professional groups. RESULTS: In total, 86 of the 270 ICU physicians and nurses completed the survey questionnaire. The majority stated they felt confident using the patient monitoring equipment, but that high rates of false-positive alarms and the many sensor cables interrupted patient care. Regarding future improvements, respondents asked for wireless sensors, a reduction in the number of false-positive alarms, and hospital standard operating procedures for alarm management. Responses to the display devices proposed for remote patient monitoring were divided. Most respondents indicated it would be useful for earlier alerting or when they were responsible for multiple wards. AI for ICUs would be useful for early detection of complications and an increased risk of mortality; in addition, the AI could propose guidelines for therapy and diagnostics. Transparency, interoperability, usability, and staff training were essential to promote the use of AI. The majority wanted to learn more about new technologies for the ICU and required more time for learning. Physicians had fewer reservations than nurses about AI-based intelligent alarm management and using mobile phones for remote monitoring. CONCLUSIONS: This survey study of ICU staff revealed key improvements for patient monitoring in intensive care medicine. Hospital providers and medical device manufacturers should focus on reducing false alarms, implementing hospital alarm standard operating procedures, introducing wireless sensors, preparing for the use of AI, and enhancing the digital literacy of ICU staff. Our results may contribute to the user-centered transfer of digital technologies into practice to alleviate challenges in intensive care medicine. TRIAL REGISTRATION: ClinicalTrials.gov NCT03514173; https://clinicaltrials.gov/ct2/show/NCT03514173.

Guideline-conform translation and cultural adaptation of the Addenbrooke's Cognitive Examination III into German.

Objective: Age-related disorders, such as dementia, significantly contribute to the global burden of disease. Adequate screening in the primary care setting is critical for early detection and proper management. The Addenbrooke's Cognitive Examination III (ACE-III) is an open-source neuropsychological test with superior diagnostic quality in comparison to the Mini-Mental State Examination (MMSE). Our aim was to perform a guideline-conform English-German translation and cultural adaptation of the ACE-III in order to enable implementation in German-speaking countries. Methods: The translation and cultural adaptation were performed in accordance with the "Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures" from the International Society for Pharmacoeconomics and Outcome Research (ISPOR) (Wild et al. 2005). Four separate English-German translations were compiled into one German consensus translation, which was then translated back into English and compared to the original English version. After comparison, the German consensus translation was revised with emphasis on the identified differences between the English original version and the English translated version. This revised German consensus translation was subsequently evaluated for clinical applicability on a 5-point scale (0 - not applicable; 5 - applicable without any restrictions) by 20 practitioners experienced in the field of neuropsychological testing, using an anonymized, paper-based 22-item survey. Results: Nineteen of the 20 practitioners (95.0%) rated the German ACE-III translation as overall applicable. The median rating was 4.0 [IQR (4.0/5.0)]. When evaluating survey items assessing the applicability of the individual 19 subtests of the ACE-III, all of them (100%) were rated as applicable with a median rating of 4.5 [IQR (4.1/4.9)]. Conclusion: The German ACE-III translation in its current form is generally applicable and can be utilized for clinical and scientific purposes.