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).

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.

Introduction Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients’ long-term outcomes if adhered to. Methods and analysis The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient’s ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated. Ethics and dissemination This protocol was approved by the ethics committee of the Charité—Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net). Trial registration number ClinicalTrials.gov Registry (NCT03671447).

There is limited knowledge about long-term mortality, care pathways and health-related quality of life (HrQoL) among intensive care unit (ICU) patients receiving prolonged mechanical ventilation (PMV). What are the long-term mortality, care pathways, and HrQoL of patients receiving invasive PMV, stratified by weaning success? and methods: We conducted a secondary analysis of patients from the cluster-randomised controlled Enhanced Recovery after Intensive Care trial who were treated in two ICU clusters and received invasive PMV (≥21 days via endotracheal tube/tracheostomy or ≥four days via tracheostomy). Data on weaning success, mortality, care place transitions, readmissions, and HrQoL were collected for six months after ICU discharge. Of 90 patients receiving PMV in the ICU, 46% (41/90 patients) died (21 patients in the ICU and 20 patients within six months after ICU discharge). Of 69 patients discharged alive, 25% (17/69 patients) could not be weaned, whereas 75% (52/69 patients) were successfully weaned within six months. Patients experienced a median of 3 [Q1, Q3: 2, 5] care place transitions within six months, with more care place transitions among successfully weaned patients (median 4 [Q1, Q3: 2, 5] vs 2 [1, 3], p=0.004). The readmission rate among all patients was 46% after six months. Half of the successfully weaned patients transitioned home, whereas unsuccessfully weaned patients mostly transitioned from weaning centres to nursing homes or died. Unsuccessfully weaned patients had fewer quality-adjusted life days within six months than successfully weaned patients (median 0 [Q1, Q3: 0, 32.6] vs 73.1 [23.2, 135], p=0.002). Three quarters of patients receiving PMV who were discharged alive were weaned, but their HrQoL was reduced. The decision to proceed with PMV should weigh in patient preferences for living with HrQoL limitations and patients' likelihood of weaning. ClinicalTrials.gov (identifier: NCT03671447) on September 12, 2018.

Objective Care bundles are considered a key tool to improve bedside quality of care in the intensive care unit (ICU). We explored their effect on long-term patient-relevant outcomes. Design Systematic literature search and scoping review. Data sources We searched PubMed, Embase, CINAHL, APA PsycInfo, Web of Science, CDSR and CENTRAL for keywords of intensive care, care bundles, patient-relevant outcomes, and follow-up studies. Eligibility criteria Original articles with patients admitted to adult ICUs assessing bundle implementations and measuring long-term (ie, ICU discharge or later) patient-relevant outcomes (ie, mortality, health-related quality of life (HrQoL), post-intensive care syndrome (PICS), care-related outcomes, adverse events, and social health). Data extraction and synthesis After dual, independent, two-stage selection and charting, eligible records were critically appraised and assessed for bundle type, implementation strategies, and effects on long-term patient-relevant outcomes. Results Of 2012 records, 38 met inclusion criteria; 55% (n=21) were before–after studies, 21% (n=8) observational cohort studies, 13% (n=5) randomised controlled trials, and 11% (n=4) had other designs. Bundles pertained to sepsis (n=11), neurocognition (n=6), communication (n=4), early rehabilitation (n=3), pharmacological discontinuation (n=3), ventilation (n=2) or combined bundles (n=9). Almost two-thirds of the studies reported on survival (n=24), 45% (n=17) on care-related outcomes (eg, discharge disposition), and 13% (n=5) of studies on HrQoL. Regarding PICS, 24% (n=9) assessed cognition, 13% (n=5) physical health, and 11% (n=4) mental health, up to 1 year after discharge. The effects of bundles on long-term patient-relevant outcomes was inconclusive, except for a positive effect of sepsis bundles on survival. The inconclusive effects may have been due to the high risk of bias in included studies and the variability in implementation strategies, instruments, and follow-up times. Conclusions There is a need to explore the long-term effects of ICU bundles on HrQoL and PICS. Closing this knowledge gap appears vital to determine if there is long-term patient value of ICU bundles.

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.