Potential risk factors for reduced quality of life and increased health care utilization in ARDS survivors: results from the multicenter cohort study DACAPO.

AIM: To analyze the association of individual pre-ICU risk factors (obesity, physical and mental comorbidity, smoking status) on the long-term recovery process in survivors of the acute respiratory distress syndrome (ARDS; outcomes: health related quality of life, health care utilization; measured at 12, 24, and 36 months after ICU discharge). FINDINGS: Results show a possible causal link between pre-ICU risk factors and subsequent recovery of survivors of ARDS, especially with regard to mental health related quality of life. PURPOSE: Identifying relevant pre-existing risk factors, such as mental health problems, will enable the identification of at-risk patients, thus aiding in the improvement of long-term healthcare for survivors of critical illness.

Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial.

BACKGROUND: ICU survivors often suffer from prolonged physical and mental impairments resulting in the so called "Post-Intensive Care Syndrome" (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care. METHODS: This pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT's primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire. RESULTS: The pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median). CONCLUSION: The participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic. TRIAL REGISTRATION: ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.

Trajectories of quality of life, return to work, psychopathology, and disability in survivors of the acute respiratory distress syndrome (ARDS): A three-year prospective cohort study (DACAPO).

PURPOSE: Describe the long-term development of outcomes for survivors of the Acute Respiratory Distress Syndrome (ARDS). MATERIAL AND METHODS: A cohort study with N = 877 ARDS survivors was conducted. Health related quality of life (HRQoL, Physical and Mental Component Scale: PCS, MCS of the SF-12), return to work (RtW), panic disorder, depressive symptoms (PHQD), and post-traumatic-stress-disorder (PTSD, PTSS-14) were assessed at 3, 6, 12, 24, and 36 months after discharge from ICU. RESULTS: PCS, MCS, and RtW increased during the first 12 months [e.g. PCS: Md = 36 (IQR 31-43) at 3 months, Md = 42 (IQR 34-52) at 12 months; MCS: Md = 44 (IQR 32-54) at 3 months, Md = 47 (IQR 33-57) at 12 months, RtW = 23.2% at 3 months, 54.5% at 12 months], and remained relatively stable afterwards. Proportion of major depressive syndrome decreased from 3 (14.2%) to 36 months (8.9%). Proportions of panic disorder (5.3% to 7.4%) and PTSD (27.1% to 32.6%) varied only slightly. CONCLUSIONS: Most of recovery in HRQoL and RtW occur during the first 12 months, after which a plateau is reached, indicating a chronification for many patients. Contrary to this, however, psychopathological symptoms remain stable, except for depressive symptoms. [200 words].

Parents' and Health Care Professionals' Perspectives on Prevention and Prediction of Food Allergies in Children: Protocol for a Qualitative Study.

BACKGROUND: Food allergy in children is increasing in prevalence in the western world and appears to become an important health problem. Parents of children at risk of food allergy live with the fear of allergic reaction, especially when the children are very young. The paradigm shift in allergy prevention in the last decade-away from allergen avoidance toward a tolerance induction approach-challenges both parents and health care professionals, as they have to deal with changing information and new evidence that often contradicts previous assumptions. Yet, research on health information-seeking behavior and needs of parents on primary prevention of food allergy in children as well as on prediction and prevention strategies of German health care professionals is lacking. OBJECTIVE: The aim of the study is to explore and understand parents' and health care professionals' perspectives on the prediction and prevention of food allergies. We are particularly interested in information needs, information seeking, and health care usage and place a special focus on families' experiences when their child is at risk or diagnosed with food allergies. Furthermore, food allergy prediction and prevention strategies of health care professionals will be explored. METHODS: This study is part of the NAMIBIO (food allergy biomarker) app consortium, which aims to identify early predictors for the development of food allergy in children and develop apps to guide health care professionals and parents of children with a high risk of food allergy toward prevention and timely tolerance induction. The study uses a qualitative approach with topic-guided interviews and focus groups with parents of children (0-3 years) and health care professionals. Data collection will continue until theoretical saturation is reached. The qualitative content analysis will be used according to Kuckartz to identify overarching themes toward information needs and seeking behavior as well as usage of health care and health care professionals' predictive and preventive strategies. In addition, a constructivist grounded theory approach will be used to explore and understand parents' experiences, interactions, and social processes in families in daily life. RESULTS: Recruitment and data collection started in February 2022 and is still ongoing. CONCLUSIONS: The qualitative study will provide insight into parents' information-seeking behavior and needs regarding the prevention of food allergy in children, parents' use of pediatric primary care, and health care professionals strategies for the prediction and prevention of food allergies in children. We assume that our results will highlight the challenges associated with the paradigm shift in allergy prevention for both parents and health care professionals. The results will be used to make practical recommendations from the user's perspective and inform the development of the NAMIBIO apps. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41436.

Association of analgosedation with psychiatric symptoms and health-related quality of life in ARDS survivors: Post hoc analyses of the DACAPO study.

BACKGROUND: The acute respiratory distress syndrome (ARDS) is a life-threatening condition with the risk of developing hypoxia and thus requires for invasive mechanical ventilation a long-term analgosedation. Yet, prolonged analgosedation may be a reason for declining health-related quality of life (HRQoL) and the development of psychiatric disorders. METHODS: We used data from the prospective observational nation­wide ARDS study across Germany (DACAPO) to investigate the influence of sedation and analgesia on HRQoL and the risk of psychiatric symptoms in ARDS survivors 3, 6 and 12 months after their discharge from the intensive care unit (ICU). HRQoL was measured with the Physical and Mental Component Scale of the Short­Form 12 Questionnaire (PCS­12, MCS­12). The prevalence of psychiatric symptoms (depression and post­traumatic stress disorder [PTSD]) was assessed using the Patient Health Questionnaire­9 and the Post­Traumatic Stress Syndrome­14. The associations of analgosedation with HRQoL and psychiatric symptoms were investigated by means of multivariable linear regression models. RESULTS: The data of 134 ARDS survivors (median age [IQR]: 55 [44-64], 67% men) did not show any significant association between analgosedation and physical or mental HRQoL up to 1 year after ICU discharge. Multivariable linear regression analysis (B [95%­CI]) yielded a significant association between symptoms of psychiatric disorders and increased cumulative doses of ketamine up to 6 months after ICU discharge (after 3 months: depression: 0.15 [0.05, 0.25]; after 6 months: depression: 0.13 [0.03, 0.24] and PTSD: 0.42 [0.04, 0.80)]). CONCLUSIONS: Up to 1 year after ICU discharge, analgosedation did not influence HRQoL of ARDS survivors. Prolonged administration of ketamine during ICU treatment, however, was positively associated with the risk of psychiatric symptoms. The administration of ketamine to ICU patients with ARDS should be with caution. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02637011 (Registered 15 December 2015, retrospectively registered).

Intensive Care Units Healthcare Professionals' Experiences and Negotiations at the Beginning of the COVID-19 Pandemic in Germany: A Grounded Theory Study.

Faced with the pandemic of the novel coronavirus (SARS-CoV-2), healthcare professionals (HCPs) in intensive care units (ICU) adjusted their organizational, operational, and personal procedures to ensure care for COVID-19 patients. We used grounded theory approach to explore ICU HCPs' perspectives on professional action at the beginning of the COVID-19 pandemic in Germany from March to July 2020. The study aimed to examine implicit principles on negotiating social practice and interaction of ICU HCPs in an exceptional situation, which was characterized by a high level of changes. We conducted theme-guided qualitative telephone/virtual interviews with 39 ICU HCPs from ten German federal states. The data collection followed the principles of theoretical sampling. We adpoted grounded theory approach proposed by Charmaz and discussed using Lüscher's theoretical concept of ambivalence. The analysis revealed five interconnected categories about the ICU HCPs' negotiation of social practice and interaction at the beginning of the COVID-19 pandemic in Germany. In this context, a complex field of ambivalence (key category) emerged between habits and routines of a pre-pandemic normality. Pragmatic restructuring processes were initiated, which quickly resulted in a new normality of a "daily routine of preparation". Dealing with ambivalence offers the potential for change.

Experiences, opinions and expectations of health care providers towards an intensive care unit follow-up clinic: Qualitative study and online survey.

OBJECTIVES: Independent of the underlying disease, intensive care unit survivors often suffer from cognitive, physical and mental impairments, also known as post-intensive care syndrome (PICS). Specific follow-up services are recommended for these patients. This study aims to capture the perspectives of health care providers on the development of the first intensive care unit follow-up-clinic in Germany. RESEARCH METHODOLOGY: A qualitative study with six focus groups (n = 41) and six expert interviews, followed by a quantitative survey was conducted, involving nine different professions. Qualitative and quantitative data were analysed using thematic analysis and descriptive statistics, respectively. FINDINGS: Participants described aftercare of former intensive care unit patients as complex and appreciated the idea of an intensive care unit follow-up clinic to improve continuity of care and multidisciplinary collaboration. The favoured model combined diagnostics and targeted referral of patients to specialists and therapists with the provision of information. In the survey, participants disagreed on how to implement this referral system but agreed that assessments should be multidimensional. CONCLUSION: The necessity of and important criteria for the design of an intensive care unit follow-up clinic were identified. We will integrate these data with further evidence to develop a concept for a complex intervention.

A qualitative study exploring content validity and feasibility of frequently used generic health-related quality of life measures in older people with hip fracture: The patients' perspective.

OBJECTIVE: To evaluate hip fracture patients´ views on content validity and feasibility of four commonly used generic measures of health-related quality of life (HRQOL). METHODS: We interviewed 32 elderly hip fracture patients without relevant cognitive impairment (mean age=81 years). Using think-aloud and verbal probing techniques, patients completed the EQ-5D descriptive system, Nottingham Health Profile (NHP), Short-Form 12 Health Questionnaire (SF-12) and WHO Quality of Life-BREF (WHOQOL-BREF). RESULTS: Patients were mostly not able to self-complete the questionnaires. Content validity was most constrained by problems in comprehensibility (e.g. vaguely phrased). Some items, for instance, were considered irrelevant if the example was inappropriate. Patients named e.g. problems with vision as important for their HRQOL, but none of the instruments included related items. CONCLUSION: Although patients reported problems with all instruments, we suggest the EQ-5D or SF-12, as these appear to have the fewest limitations in content validity and feasibility from the patient´s perspective.