Haloperidol for the Treatment of Delirium in ICU Patients.

BACKGROUND: Haloperidol is frequently used to treat delirium in patients in the intensive care unit (ICU), but evidence of its effect is limited. METHODS: In this multicenter, blinded, placebo-controlled trial, we randomly assigned adult patients with delirium who had been admitted to the ICU for an acute condition to receive intravenous haloperidol (2.5 mg 3 times daily plus 2.5 mg as needed up to a total maximum daily dose of 20 mg) or placebo. Haloperidol or placebo was administered in the ICU for as long as delirium continued and as needed for recurrences. The primary outcome was the number of days alive and out of the hospital at 90 days after randomization. RESULTS: A total of 1000 patients underwent randomization; 510 were assigned to the haloperidol group and 490 to the placebo group. Among these patients, 987 (98.7%) were included in the final analyses (501 in the haloperidol group and 486 in the placebo group). Primary outcome data were available for 963 patients (97.6%). At 90 days, the mean number of days alive and out of the hospital was 35.8 (95% confidence interval [CI], 32.9 to 38.6) in the haloperidol group and 32.9 (95% CI, 29.9 to 35.8) in the placebo group, with an adjusted mean difference of 2.9 days (95% CI, -1.2 to 7.0) (P = 0.22). Mortality at 90 days was 36.3% in the haloperidol group and 43.3% in the placebo group (adjusted absolute difference, -6.9 percentage points [95% CI, -13.0 to -0.6]). Serious adverse reactions occurred in 11 patients in the haloperidol group and in 9 patients in the placebo group. CONCLUSIONS: Among patients in the ICU with delirium, treatment with haloperidol did not lead to a significantly greater number of days alive and out of the hospital at 90 days than placebo. (Funded by Innovation Fund Denmark and others; AID-ICU ClinicalTrials.gov number, NCT03392376; EudraCT number, 2017-003829-15.).

A world-wide study on delirium assessments and presence of protocols.

BACKGROUND: Delirium is a common complication of older people in hospitals, rehabilitation and long-term facilities. OBJECTIVE: To assess the worldwide use of validated delirium assessment tools and the presence of delirium management protocols. DESIGN: Secondary analysis of a worldwide one-day point prevalence study on World Delirium Awareness Day, 15 March 2023. SETTING: Cross-sectional online survey including hospitals, rehabilitation and long-term facilities. METHODS: Participating clinicians reported data on delirium, the presence of protocols, delirium assessments, delirium-awareness interventions, non-pharmacological and pharmacological interventions, and ward/unit-specific barriers. RESULTS: Data from 44 countries, 1664 wards/units and 36 048 patients were analysed. Validated delirium assessments were used in 66.7% (n = 1110) of wards/units, 18.6% (n = 310) used personal judgement or no assessment, and 10% (n = 166) used other assessment methods. A delirium management protocol was reported in 66.8% (n = 1094) of wards/units. The presence of protocols for delirium management varied across continents, ranging from 21.6% (on 21/97 wards/units) in Africa to 90.4% (235/260) in Australia, similar to the use of validated delirium assessments with 29.6% (29/98) in Africa to 93.5% (116/124) in North America. Wards/units with a delirium management protocol [n = 1094/1664, 66.8%] were more likely to use a validated delirium test than those without a protocol [odds ratio 6.97 (95% confidence interval 5.289-9.185)]. The presence of a delirium protocol increased the chances for valid delirium assessment and, likely, evidence-based interventions. CONCLUSION: Wards/units that reported the presence of delirium management protocols had a higher probability of using validated delirium assessments tools to assess for delirium.

How flash mobs can be used for data collection in healthcare? A scoping review protocol.

BACKGROUND: Traditional research methods often involve a lengthy process, but the emergence of flash mobs as an innovative data collection method offers the potential to gather substantial data within a short time frame. Flash mobs draw inspiration from the concept of large groups organizing through the internet or mobile devices to perform a prearranged action in public. In healthcare research, flash mobs serve as research organizing method to investigate clinically relevant questions on a large scale within a limited period. AIMS: This study aims to present a study protocol for a scoping review that comprehensively maps the existing literature on the use of flash mobs as a data collection method in healthcare research. METHODS: The review will follow established guidelines and include steps such as identifying the research question, identifying relevant studies, selecting studies, charting the data, and collating and summarizing the results. The review will utilize databases, manual screening of additional sources, and covidence for study selection and data charting. The findings will be summarized using descriptive statistics and a descriptive synthesis of qualitative data. The review protocol has been registered with the Open Science Framework. RESULTS: The results of this scoping review will provide insights into different flash mob designs, motivations, and the data collection process, contributing to the development of high-quality flash mob data collections in healthcare research.

Patient recall of intensive care delirium: A qualitative investigation.

BACKGROUND: Many patients in the Intensive Care Unit (ICU) experience delirium. Understanding the patient perspective of delirium is important to improve care and reduce suffering. The aim of our study was to investigate the subjective patient experience of delirium, delirium-related distress, and delirium management in ICU. METHODS: Our study had a qualitative multicenter design applying individual interviews and thematic analysis. Participants were critically ill adult patients that were determined delirium positive according to validated delirium screening tools during ICU admission. The interviews were conducted after ICU discharge when patients were delirium-free as assessed by the "Rapid clinical test for delirium" (4AT) and able to participate in an interview. RESULTS: We interviewed 30 patients choosing the main themes deductively: Delirium experience; Delirium related distress; and Delirium management. Despite variations in recollection detail, ICU survivors consistently reported delirium-related distress during and after their ICU stay, manifesting as temporal confusion, misinterpretations, and a sense of distrust towards ICU staff. Delusions were characterized by a blend of factual and fictional elements. Impaired short-term memory hindered communication and intensified feelings of isolation, neglect, and loss of control. CONCLUSION: The ICU survivors in our study recalled delirium as an unpleasant and frightening experience, often leading to delirium-related distress during and after their ICU stay, indicating the necessity for enhanced assessment and treatment.

The parent perspective on paediatric delirium and an associated care bundle: A qualitative study.

AIMS: To explore how parents experienced their child with delirium and how parents viewed our delirium management bundle. DESIGN: We conducted a qualitative exploratory descriptive study using semi-structured individual or dyad interviews. METHODS: Twelve semi-structured interviews with 16 parents of 12 critically ill children diagnosed with delirium in a paediatric intensive care unit were conducted from October 2022 to January 2023 and analysed through a reflexive thematic analysis. FINDINGS: We generated five themes: (1) knowing that something is very wrong, (2) observing manifest changes in the child, (3) experiencing fear of long-term consequences, (4) adding insight to the bundle, and (5) family engagement. CONCLUSION: The parents in our study were able to observe subtle and manifest changes in their child with delirium. This caused fear of lasting impact. The parents regarded most of the interventions in the delirium management bundle as relevant but needed individualization in the application. The parents requested more information regarding delirium and a higher level of parent engagement in the care of their child during delirium. IMPACT: This paper contributes to understanding how parents might experience delirium in their critically ill child, how our delirium management bundle was received by the parents, and their suggestions for improvement. Our study deals with critically ill children with delirium, their parents, and staff working to prevent and manage paediatric delirium (PD) in the paediatric intensive care unit. REPORTING METHOD: The consolidated criteria for reporting qualitative research guidelines were used to ensure the transparency of our reporting. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution to the research design. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL COMMUNITY?: - It increases awareness of the parent's perspective on PD in critically ill children. - It shows how PD might affect parents, causing negative emotions such as distress, frustration, and fear of permanent damage. - It shows that the parents in our study, in addition to the care bundle, requested more information on delirium and more involvement in the care of their delirious child.

Delirium and delirium severity screening in the intensive care-correspondence of screenings tools.

BACKGROUND: Delirium severity scores are gaining acceptance for measuring delirium in the intensive care unit (ICU). OBJECTIVE: The aim of this study was to evaluate the concordance between the Confusion Assessment Method for the intensive care unit (CAM-ICU)-7 and the Intensive Care Delirium Screening Checklist (ICDSC) as delirium severity measurement tools. METHODS: This was a prospective, comparative, observational multicentre study. This study was conducted in 18 Danish ICUs. Delirium was assessed in adult critically ill patients admitted to an ICU with a Richmond Agitation and Sedation Score (RASS) of -2 or above. ICU nurses assessed delirium with randomised paired delirium screening instruments, using the CAM-ICU, the ICDSC, and the CAM-ICU-7. The correlation between the CAM-ICU-7 and the ICDSC severity scores was evaluated for all predefined patient subgroups. RESULTS: A total of 1126 paired screenings were conducted by 127 ICU nurses in 850 patients. The patients' median age was 70 years (interquartile range: 61-77), 40% (339/850) were female, and 54% (457/850) had at least one positive delirium score. Delirium severity ranges (CAM-ICU-7: 0-7; and ICDSC: 0-8) were positively correlated (Pearson's correlation coefficient, r = 0.83; p < 0.0001). The overall agreement between the CAM-ICU-7 and the ICDSC for delirium measurement (CAM-ICU-7: >2, and ICDSC: >3) was substantial (kappa = 0.74), but the agreement decreased to fair (kappa = 0.38) if a patient had a RASS less than 0. CONCLUSIONS: The agreement between the CAM-ICU-7 and the ICDSC for delirium severity measurement was substantial but might be affected by the patient's sedation and agitation level at the time of assessment. IMPLICATIONS FOR PRACTICE: Both CAM-ICU-7 and ICDSC can be implemented for delirium severity measurement. Attention is warranted in both scores if a patient has a RASS of -2.

Haloperidol for the treatment of delirium in critically ill patients: an updated systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Haloperidol is frequently used in critically ill patients with delirium, but evidence for its effects has been sparse and inconclusive. By including recent trials, we updated a systematic review assessing effects of haloperidol on mortality and serious adverse events in critically ill patients with delirium. METHODS: This is an updated systematic review with meta-analysis and trial sequential analysis of randomised clinical trials investigating haloperidol versus placebo or any comparator in critically ill patients with delirium. We adhered to the Cochrane handbook, the PRISMA guidelines and the grading of recommendations assessment, development and evaluation statements. The primary outcomes were all-cause mortality and proportion of patients with one or more serious adverse events or reactions (SAEs/SARs). Secondary outcomes were days alive without delirium or coma, delirium severity, cognitive function and health-related quality of life. RESULTS: We included 11 RCTs with 15 comparisons (n = 2200); five were placebo-controlled. The relative risk for mortality with haloperidol versus placebo was 0.89; 96.7% CI 0.77 to 1.03; I2 = 0% (moderate-certainty evidence) and for proportion of patients experiencing SAEs/SARs 0.94; 96.7% CI 0.81 to 1.10; I2 = 18% (low-certainty evidence). We found no difference in days alive without delirium or coma (moderate-certainty evidence). We found sparse data for other secondary outcomes and other comparators than placebo. CONCLUSIONS: Haloperidol may reduce mortality and likely result in little to no change in the occurrence of SAEs/SARs compared with placebo in critically ill patients with delirium. However, the results were not statistically significant and more trial data are needed to provide higher certainty for the effects of haloperidol in these patients. TRIAL REGISTRATION: CRD42017081133, date of registration 28 November 2017.

Patient and public involvement in contemporary large intensive care trials: A meta-epidemiological study.

BACKGROUND: Patient and public involvement in randomised clinical trials has received increased focus, including in intensive care trials, but the frequency, method and extent is unknown. This meta-epidemiological study investigated patient and public involvement in contemporary, large ICU trials. METHODS: We systematically searched PubMed for large (≥225 randomised patients), contemporary trials (published between 1 January 2019 and 31 January 2022) assessing interventions in adult patients in ICU settings. Abstracts and full-text articles were assessed independently and in duplicate. Data were extracted using a pre-defined, pilot-tested data extraction form with details on trials, patient and public involvement including categories and numbers of individuals involved, methods of involvement, and trial stage(s) with involvement. Trials authors were contacted as necessary. RESULTS: We included 100 trials, with 18 using patient and public involvement; these were larger and conducted in more centres than trials without patient and public involvement. Among trials with patient and public involvement, patients (in 14/18 trials), clinicians (13 trials), and family members (12 trials) were primarily involved, mainly in the development of research design (15 trials) and development of research focus (13 trials) stages and mostly by discussion (12 trials) and solo interviews (10 trials). A median of 65 individuals (range 1-6894) were involved. CONCLUSIONS: We found patient and public involvement in a fifth of large, contemporary ICU trials. Primarily patients, families, and clinicians were included, particularly in the trial planning stages and mostly through interviews and discussions. Increased patient and public involvement in ICU trials is warranted.

Functional and cognitive rehabilitation interventions during intensive care admission: A protocol for a systematic integrative review.

BACKGROUND: Long-term cognitive impairment occurs in up to 60% of intensive care unit (ICU) survivors. Early use of functional and cognitive rehabilitation interventions, while patients are still in ICU, may reduce cognitive decline. We aim to describe the functional and cognitive interventions used during the ICU stay, the healthcare professionals providing interventions, and the potential impact on functional and cognitive rehabilitation. METHOD: In this integrative systematic review, we will include empirical qualitative, quantitative, mixed- and multiple-methods studies assessing the use of functional and cognitive rehabilitation provided in ICU. We will identify studies in relevant electronic databases from 2012 to 2022, which will be screened for eligibility by at least two reviewers. Literature reported as narrative reviews and editorials will be excluded. We will assess the impact of interventions evaluating a cognitive and functional function, quality of life, and all-cause mortality at 6-12 months after ICU discharge. The Revised Cochrane risk-of-bias Tool will be used for assessing risk of bias in clinical trials. For observational studies, we will use the National Institutes of Health Quality Assessment tool for Observational Cohort and Cross-Sectional Studies. Furthermore, we will use the critical appraisal skills programme for qualitative studies and the mixed methods appraisal tool for mixed methods studies. We will construct four matrices, including results describing which ICU patients and healthcare professionals were engaged in rehabilitation, which interventions were included in early rehabilitation in ICU, the potential impact on patient outcomes of rehabilitation interventions provided in ICU and a narrative synthesis of themes. A summary of the main results will be reported using modified GRADE methodology. IMPACT: This integrative review will inform the feasibility randomised clinical trial testing the development of a complex intervention targeting functional and cognitive rehabilitation for patients in ICU.

A survey of preferences for respiratory support in the intensive care unit for patients with acute hypoxaemic respiratory failure.

BACKGROUND: When caring for mechanically ventilated adults with acute hypoxaemic respiratory failure (AHRF), clinicians are faced with an uncertain choice between ventilator modes allowing for spontaneous breaths or ventilation fully controlled by the ventilator. The preferences of clinicians managing such patients, and what motivates their choice of ventilator mode, are largely unknown. To better understand how clinicians' preferences may impact the choice of ventilatory support for patients with AHRF, we issued a survey to an international network of intensive care unit (ICU) researchers. METHODS: We distributed an online survey with 32 broadly similar and interlinked questions on how clinicians prioritise spontaneous or controlled ventilation in invasively ventilated patients with AHRF of different severity, and which factors determine their choice. RESULTS: The survey was distributed to 1337 recipients in 12 countries. Of these, 415 (31%) completed the survey either fully (52%) or partially (48%). Most respondents were identified as medical specialists (87%) or physicians in training (11%). Modes allowing for spontaneous ventilation were considered preferable in mild AHRF, with controlled ventilation considered as progressively more important in moderate and severe AHRF. Among respondents there was strong support (90%) for a randomised clinical trial comparing spontaneous with controlled ventilation in patients with moderate AHRF. CONCLUSIONS: The responses from this international survey suggest that there is clinical equipoise for the preferred ventilator mode in patients with AHRF of moderate severity. We found strong support for a randomised trial comparing modes of ventilation in patients with moderate AHRF.

Patient and family engagement in Danish intensive care units: A national survey.

BACKGROUND: Patient and family engagement in the intensive care unit increases the quality of care and patient safety. AIM: The aim of our study was to describe current practice and experiences of contemporary patient and family engagement in the intensive care unit at the individual level, the organizational level, and in the research process according to critical care nurses. DESIGN/METHOD: We conducted a national qualitative survey of intensive care units in Denmark from 5th May-5th June 2021. Questionnaires were piloted and sent to intensive care nurse specialists and research nurses at 41 intensive care units, allowing one respondent per unit. All respondents were provided with written information about the study by email, and by activating the survey link, they accepted participation. RESULTS: Thirty-two nurses responded to the invitation, 24 completed and 8 partially completed the survey, yielding a response rate of 78%. At the individual level, 27 respondents stated that they involved patients and 25 said they involved family in daily treatment and care. At the organizational level, 28 intensive care units had an overall strategy or guideline for patient and family engagement, and 4 units had established a PFE panel. And, finally, 11 units engaged patients and families in the research process. CONCLUSIONS: Our survey suggested that patient and family engagement was implemented to some degree at the individual level, organizational level, and in the research process, but only 4 units had established a PFE panel at the organizational level, which is key to engagement. RELEVANCE TO CLINICAL PRACTICE: Patient engagement increases when patients are more awake, and family engagement increases when patients are unable to participate. Engagement increases when patient and family engagement panels are implemented.

Struggling to return to everyday life-The experiences of quality of life 1 year after delirium in the intensive care unit.

BACKGROUND: Many critically ill patients report a change in their health-related quality of life after intensive care unit (ICU) discharge. Patients who experience delirium during their ICU stay are perceived as a fragile group of ICU survivors, and the 'quality of life' phenomenon needs to be studied among these patients. AIM: To explore everyday life experiences of critically ill patients with delirium during the ICU stay, from ICU discharge until 1-year follow-up, focusing on their health-related quality of life and cognitive function. STUDY DESIGN: We used a descriptive qualitative research design and interviewed patients 1 year after ICU admission. The participants were recruited from a pre-planned one-year follow-up study of 'Agents Intervening against Delirium for patients in the Intensive Care Unit trial'. Data were analysed using Framework Analysis Method and content analysis. RESULTS: Nine women and eight men participated and reported a struggle when returning to everyday life or adapting to a new normality from hospital discharge to 1 year later. None of the participants had been aware of the challenges they would face after hospital discharge. They described a need for more information about these challenges to themselves and about primary care to better understand their situation and the struggles they experience during recovery. One overall theme emerged from the analysis 'From enduring to adapting' with three subthemes: 'Struggling to regain a functional life', 'Struggling to regain normal cognition' and 'Distressing manifestations from the ICU'. CONCLUSIONS: To improve recovery and the quality of rehabilitation for critically ill patients suffering from delirium, it is essential to understand the phenomenon of ICU survivorship and what this fragile group of patients is going through. It is necessary to bridge the gap between secondary and primary care so patients can receive optimal training and support when needed. RELEVANCE TO CLINICAL PRACTICE: Bridging the gap between primary and secondary healthcare services is urgently needed to improve rehabilitation for ICU survivors after critical illness.

Intensive care unit nurses' perception of three different methods for delirium screening: A survey (DELIS-3).

BACKGROUND: Delirium is common in critically ill patients with detrimental effects in terms of increased morbidity, mortality, costs, and human suffering. Delirium detection and management depends on systematic screening for delirium, which can be challenging to implement in clinical practice. OBJECTIVES: The aim of this study was to explore how nurses in the intensive care unit perceived the use of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), the Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7), and Intensive Care Delirium Screening Checklist (ICDSC) for delirium screening of patients in the intensive care unit. METHODS: This was a cross-sectional, electronic-based survey of nurses' perceptions of delirium screening with the three different instruments for delirium screening. Nurses were asked to grade their perception of the usability of the three instruments and how well they were perceived to detect delirium and delirium symptom changes on a 1- to 6-point Likert scale. Open questions about perceived advantages and disadvantages of each instrument were analysed using the framework method. RESULTS: One hundred twenty-seven of 167 invited nurses completed the survey and rated the CAM-ICU-7 as faster and easier than the ICDSC, which was more nuanced and reflected changes in the patient's delirium better. Despite being rated as the fastest, easiest, and most used, the CAM-ICU provided less information and was considered inferior to the CAM-ICU-7 and ICDSC. Using familiar instruments made delirium screening easier, but being able to grade and nuance the delirium assessment was experienced as important for clinical practice. CONCLUSIONS: Both the ICDSC and the CAM-ICU-7 were perceived well suited for detection of delirium and reflected changes in delirium intensity. The CAM-ICU was rated as fast and easy but inferior in its ability to grade and nuance the assessment of delirium. Emphasis on clinical meaningfulness and continued education in delirium screening are necessary for adherence to delirium management guidelines.

Distribution of delirium motor subtypes in the intensive care unit: a systematic scoping review.

BACKGROUND: Delirium is the most common cerebral dysfunction in the intensive care unit (ICU) and can be subdivided into a hypoactive, hyperactive, or mixed motor subtype based on the clinical manifestation. The aim of this review was to describe the distribution, pharmacological interventions, and outcomes of delirium motor subtypes in ICU patients. METHODS: This systematic scoping review was performed according to the PRISMA-ScR and Cochrane guidelines. We performed a systematic search in six major databases to identify relevant studies. A meta-regression analysis was performed where pooled estimates with 95% confidence intervals were computed by a random effect model. RESULTS: We included 131 studies comprising 13,902 delirious patients. There was a large between-study heterogeneity among studies, including differences in study design, setting, population, and outcome reporting. Hypoactive delirium was the most prevalent delirium motor subtype (50.3% [95% CI 46.0-54.7]), followed by mixed delirium (27.7% [95% CI 24.1-31.3]) and hyperactive delirium (22.7% [95% CI 19.0-26.5]). When comparing the delirium motor subtypes, patients with mixed delirium experienced the longest delirium duration, ICU and hospital length of stay, the highest ICU and hospital mortality, and more frequently received administration of specific agents (antipsychotics, α2-agonists, benzodiazepines, and propofol) during ICU stay. In studies with high average age for delirious patients (> 65 years), patients were more likely to experience hypoactive delirium. CONCLUSIONS: Hypoactive delirium was the most prevalent motor subtype in critically ill patients. Mixed delirium had the worst outcomes in terms of delirium duration, length of stay, and mortality, and received more pharmacological interventions compared to other delirium motor subtypes. Few studies contributed to secondary outcomes; hence, these results should be interpreted with care. The large between-study heterogeneity suggests that a more standardized methodology in delirium research is warranted.

Development of a core outcome set for general intensive care unit patients-A protocol.

INTRODUCTION: Different outcomes are reported in randomised clinical trials (RCTs) in intensive care unit (ICU) patients, and no core outcome set (COS) is available for ICU patients in general. Accordingly, we aim to develop a COS for ICU patients in general. METHODS: The COS will be developed in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Handbook, using a modified Delphi consensus process and semi-structured interviews involving adults who have survived acute admission to an ICU, family members, clinicians, researchers and other stakeholders. The modified Delphi process will include two steps. Step 1: conduction of a modified Delphi survey, developed and informed by combining the outputs of a literature search of outcomes in previous COSs and semi-structured interviews with key stakeholders. We plan at least two survey rounds to obtain consensus and refine the COS. Step 2: a consensus process regarding instruments or definitions to be recommended for the measurements of the outcomes selected in Step 1. A 'patient and public involvement panel' consisting of a smaller group of patients, family members, clinicians and researchers will be included in the development, analysis and interpretation of the COS. DISCUSSION: The outlined multiple method studies will establish a COS for ICU patients in general, which may be used to increase the standardisation and comparability of results of RCTs conducted in patients in the ICU setting.

Agents intervening against delirium in the intensive care unit trial-Protocol for a secondary Bayesian analysis.

BACKGROUND: Delirium is highly prevalent in the intensive care unit (ICU) and is associated with high morbidity and mortality. The antipsychotic haloperidol is the most frequently used agent to treat delirium although this is not supported by solid evidence. The agents intervening against delirium in the intensive care unit (AID-ICU) trial investigates the effects of haloperidol versus placebo for the treatment of delirium in adult ICU patients. METHODS: This protocol describes the secondary, pre-planned Bayesian analyses of the primary and secondary outcomes up to day 90 of the AID-ICU trial. We will use Bayesian linear regression models for all count outcomes and Bayesian logistic regression models for all dichotomous outcomes. We will adjust for stratification variables (site and delirium subtype) and use weakly informative priors supplemented with sensitivity analyses using sceptical priors. We will present results as absolute differences (mean differences and risk differences) and relative differences (ratios of means and relative risks). Posteriors will be summarised using median values as point estimates and percentile-based 95% credibility intervals. Probabilities of any benefit/harm, clinically important benefit/harm and clinically unimportant differences will be presented for all outcomes. DISCUSSION: The results of this secondary, pre-planned Bayesian analysis will complement the primary frequentist analysis of the AID-ICU trial and facilitate a nuanced and probabilistic interpretation of the trial results.

Patients' experiences of well-being when being cared for in the intensive care unit-An integrative review.

OBJECTIVE: The aim of this integrative review was to identify facilitators and barriers to patients' well-being when being cared for in an ICU setting, from the perspective of the patients. BACKGROUND: To become critically ill and hospitalised in an ICU is a stressful, chaotic event due to the life-threatening condition itself, as well as therapeutic treatments and the environment. A growing body of evidence has revealed that patients often suffer from physical, psychological and cognitive problems after an ICU stay. Several strategies, such as sedation and pain management, are used to reduce stress and increase well-being during ICU hospitalisation, but the ICU experience nevertheless affects the body and mind. DESIGN; METHODS: Since research exploring patients' sense of well-being in an ICU setting is limited, an integrative review approach was selected. Searches were performed in CINAHL, Medline, Psych Info, Eric and EMBASE. After reviewing 66 studies, 12 studies were included in the integrative review. Thematic analysis was used to analyse the studies. The PRISMA checklist for systematic reviews was used. RESULTS: The results are presented under one main theme, 'Well-being as a multidimensional experience-interwoven in barriers and facilitators' and six sub-themes representing barriers to and facilitators of well-being in an ICU. Barriers identified were physical stressors, emotional stressors, environmental disturbances and insecurity relating to time and space. Facilitators were meeting physical needs and activities that included dimensions of a caring and relational environment. CONCLUSION: Our main findings were that experiences of well-being were multidimensional and included physical, emotional, relational and environmental aspects, and they were more often described through barriers than facilitators of well-being. RELEVANCE FOR CLINICAL PRACTICE: This integrative review has shown that it is necessary to adopt an individual focus on patient well-being in an ICU setting since physical, emotional, relational and environmental stressors might impact each patient differently.

Risk factors for long-term cognitive impairment in ICU survivors: A multicenter, prospective cohort study.

PURPOSE: To describe the incidence of and risk factors for impaired cognitive function in intensive care unit (ICU) survivors. We hypothesized that age, severity of illness, and days in coma, delirium, mechanical ventilation in the ICU would be associated with impaired cognitive function. METHODS: We included all adults, alive 6 months after acute admission to one of the 24 Danish ICUs participating in the AID-ICU cohort study. Trained professionals assessed cognitive function in patients' homes or in outpatient clinics using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 6 months after ICU admission. Potential risk factors for cognitive impairment were analyzed with linear regression models. RESULTS: In total, 237 ICU patients were alive 6 months after ICU admission and did not meet the exclusion criteria. A total of 106 patients completed the cognitive assessment. The median RBANS global cognitive score was 76 (interquartile range, 62-91), and 52% had a global cognitive score 1.5 SD below the normative mean and 36% displayed a global cognitive score 2 SD below the normative mean, similar to that of Alzheimer's disease. Higher age was associated with poorer RBANS global cognitive score (estimate -0.35 [95% confidence interval -0.63 to -0.07] per year). CONCLUSIONS: In this multicenter study of adult ICU survivors, cognitive impairment was frequent and severe in those assessed at 6 months. Higher age was a risk factor for cognitive impairment, but events related to the ICU stay were not associated with poorer cognitive performance at 6 months.

Does rocking motion calm delirious patients in ICU? A multicentre randomised clinical trial protocol (RockingICU).

BACKGROUND: Rocking chair therapy has been explored in patients with dementia to promote the feeling of relaxation, but not in Intensive Care Unit (ICU) patients with delirium. AIM: The aim is to investigate the effect of a chair with or without rocking motion on the duration of delirium and intensity of agitation in critically ill patients admitted to the ICU. DESIGN: This is an investigator-initiated pragmatic, multicentre, parallel-grouped, centrally randomised, stratified, data analyst-blinded trial. METHOD: We will include patients for 1:1 web-based randomisation, stratified by site in patients 18 y or older with a positive delirium score identified by a validated tool. We will exclude patients mainly due to mobilisation restrictions, body weight exceeding 130 kg, inability to provide consent, and presence of multiresistant bacteria or viral droplet infections. The intervention group will receive a minimum of 20 min of rocking therapy daily. The control group will be transferred to the same type of chair but without rocking therapy daily. A power calculation with a risk reduction of 20%, a power of 80% with an alpha cut-off on 5% and further 20% inclusion gives 76 patients in intervention and control group reaching a total of n = 152 inclusion in the trial. CONCLUSION: The RockingICU trial will provide important new knowledge and raise research questions regarding nonpharmacological interventions to alleviate delirium in ICU patients.

Patient and public involvement in contemporary large intensive care trials: Protocol for a meta-epidemiological study.

BACKGROUND: Patient and public involvement (PPI) in randomized clinical trials (RCTs) has increased in recent years but remains the exception rather than the rule. We aim to assess the frequency and extent of PPI in large, contemporary RCTs conducted in an intensive care setting. METHODS AND DESIGN: We will conduct a meta-epidemiological study of RCTs conducted in intensive care settings published since 2019 and assess their use of PPI. We will extract trial characteristics and verify the use of PPI with trial authors unless specifically stated in the published paper. The primary outcome will be the proportion of trials that use PPI. Secondary outcomes will explore which groups are consulted, at which stage of the trial process this occurs, and by what means these opinions are collected and implemented. DISCUSSION: This meta-epidemiological study will provide an important insight into the use of PPI in large, contemporary intensive care trials. We wish to reveal ways in which patient involvement could be incorporated more broadly and purposefully here and help to empower clinicians, researchers and patients to collaborate further on future research processes and goals.