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.

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.

Delirium screening instruments.

Delirium in patients has well-documented adverse physical and mental outcomes. Delirium impairs patients' capacity to grasp and retain information, thus affecting their right to informed consent and active participation in treatment and care decisions. In Danish hospitals, delirium afflicts up to 50% of the elderly patients, yet it often goes unreported due to the absence of systematic screening. The selection of a screening tool should be contextually relevant. This review gives an overview of delirium screening instruments available in Danish, each with distinct advantages and disadvantages.

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.

Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium.

PURPOSE: We assessed long-term outcomes in acutely admitted adult patients with delirium treated in intensive care unit (ICU) with haloperidol versus placebo. METHODS: We conducted pre-planned analyses of 1-year outcomes in the Agents Intervening against Delirium in the ICU (AID-ICU) trial, including mortality and health-related quality of life (HRQoL) assessed by Euroqol (EQ) 5-dimension 5-level questionnaire (EQ-5D-5L) index values and EQ visual analogue scale (EQ VAS) (deceased patients were assigned the numeric value zero). Outcomes were analysed using logistic and linear regressions with bootstrapping and G-computation, all with adjustment for the stratification variables (site and delirium motor subtype) and multiple imputations for missing HRQoL values. RESULTS: At 1-year follow-up, we obtained vital status for 96.2% and HRQoL data for 83.3% of the 1000 randomised patients. One-year mortality was 224/501 (44.7%) in the haloperidol group versus 251/486 (51.6%) in the placebo group, with an adjusted absolute risk difference of - 6.4%-points (95% confidence interval [CI] - 12.8%-points to - 0.2%-points; P = 0.045). These results were largely consistent across the secondary analyses. For HRQoL, the adjusted mean differences were 0.04 (95% CI - 0.03 to 0.11; P = 0.091) for EQ-5D-5L-5L index values, and 3.3 (95% CI - 9.3 to 17.5; P = 0.142) for EQ VAS. CONCLUSIONS: In acutely admitted adult ICU patients with delirium, haloperidol treatment reduced mortality at 1-year follow-up, but did not statistically significantly improve HRQoL.

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.

Platform trials.

Platform trials focus on the perpetual testing of many interventions in a disease or a setting. These trials have lasting organizational, administrative, data, analytic, and operational frameworks making them highly efficient. The use of adaptation often increases the probabilities of allocating participants to better interventions and obtaining conclusive results. The COVID-19 pandemic showed the potential of platform trials as a fast and valid way to improved treatments. This review gives an overview of key concepts and elements using the Intensive Care Platform Trial (INCEPT) as an example.

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.

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 Nordic healthcare research: a scoping review of contemporary practice.

BACKGROUND: Over the past decades, there has been a growing international interest in user involvement in healthcare research. However, evidence on the management and impact of patient and public involvement in Nordic healthcare research remains limited. OBJECTIVE: The aim was to explore and delineate the current state, practice, and impact of patient and public involvement in healthcare research across different areas of healthcare and patient populations in the Nordic countries. METHODS: We conducted a scoping review using nine scientific databases and gray literature from 1992-2023. Sources were categorized as empirical or non-empirical. We used the Guidance for Reporting Involvement of Patients and the Public Short Form 2 checklist for reporting of patient and public involvement in healthcare research and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. RESULTS: A total of 56 publications were included, consisting of 39 empirical and 17 non-empirical sources. Gray literature varied among countries and institutions encompassing different types of documents. We found an increase in the number of publications on patient and public involvement in Nordic healthcare research. This was evidenced by the growing number of references and institutional initiatives intended at involving the public, indicating the increasing emphasis on patient and public involvement in Nordic healthcare research. The terminology used to describe patient and public involvement varied over time. However, there has been a gradual narrowing down of terms as the concept of PPI has become more integrated into research practices, particularly with the involvement of funding agencies. CONCLUSION: The utilization of patient and public involvement in Nordic healthcare research has substantially increased, proliferated, and gained widespread acceptance across diverse healthcare domains. The variety of approaches challenged our scoping review in terms of systematic description and impact. Patient and public involvement was applied in one or more research stages using different methodologies and terms. International agreement on terms and definitions is needed for reliable interpretation of the use of patient and public involvement in Nordic healthcare research.

Over the past decades the importance of involving patients and the public as active partners in healthcare research has received growing acknowledgement internationally. Nonetheless, our knowledge regarding the degree of patient and public involvement (PPI) in the Nordic countries remains limited. This paper addresses this gap by investigating the status, management, and influence of PPI in healthcare research within the Nordic countries. The review of these aspects has given us a better understanding of PPI and its effects on healthcare research in the Nordic region. We looked at scientific databases and webpages including research papers, commentaries, and other materials from Denmark, Norway, Sweden, Finland, and Iceland. Our goal was to gather information and provide a thorough overview of PPI practices. Our findings showed that PPI is growing with gained acceptance across different areas of health research. PPI was used at different stages of the research process, but there wasn't a common agreement on its importance and the additional value it brings to the quality of research. The study was challenged by the many different terms and definitions, which affected the clarity of our study's purpose (or goals).However, we made efforts to address this by carefully reviewing the different terms and definitions used in the literature, striving to capture the essence of PPI in our analysis. By acknowledging this variation, we aimed to provide a wide-ranging overview while identifying the complexities and nuances related with PPI in the Nordic healthcare research. We assume that achieving international agreement on terms and definitions of PPI would certainly improve the trustworthiness in future reviews.

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.

Haloperidol vs. placebo for the treatment of delirium in ICU patients: a pre-planned, secondary Bayesian analysis of the AID-ICU trial.

PURPOSE: The AID-ICU trial was a randomised, blinded, placebo-controlled trial investigating effects of haloperidol versus placebo in acutely admitted, adult patients admitted in intensive care unit (ICU) with delirium. This pre-planned Bayesian analysis facilitates probabilistic interpretation of the AID-ICU trial results. METHODS: We used adjusted Bayesian linear and logistic regression models with weakly informative priors to analyse all primary and secondary outcomes reported up to day 90, and with sensitivity analyses using other priors. The probabilities for any benefit/harm, clinically important benefit/harm, and no clinically important differences with haloperidol treatment according to pre-defined thresholds are presented for all outcomes. RESULTS: The mean difference for days alive and out of hospital to day 90 (primary outcome) was 2.9 days (95% credible interval (CrI) - 1.1 to 6.9) with probabilities of 92% for any benefit and 82% for clinically important benefit. The risk difference for mortality was - 6.8 percentage points (95% CrI - 12.8 to - 0.8) with probabilities of 99% for any benefit and 94% for clinically important benefit. The adjusted risk difference for serious adverse reactions was 0.3 percentage points (95% CrI - 1.3 to 1.9) with 98% probability of no clinically important difference. Results were consistent across sensitivity analyses using different priors, with more than 83% probability of benefit and less than 17% probability of harm with haloperidol treatment. CONCLUSIONS: We found high probabilities of benefits and low probabilities of harm with haloperidol treatment compared with placebo in acutely admitted, adult ICU patients with delirium for the primary and most secondary outcomes.

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.

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.

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.

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.).

"FastSchool": A single session of an interprofessional pain management program for chronic pain patients inspired by cognitive behavioral therapy.

OBJECTIVES: Multidisciplinary approaches to treating chronic pain have been proven effective. Currently, chronic pain patients face lengthy waitlists in pain medicine departments. To overcome this problem, we developed the "FastSchool" program to educate patients about pain management and treatment. In this study, we evaluated the benefit of a "FastSchool" session on pain and catastrophizing in chronic pain patients. METHODS: Included patients had chronic non-cancer pain, no more than 2 visits to a pain medicine department. Patients attended a single 3-hour session, conducted by an interprofessional team. Four topics were addressed: chronic pain mechanisms, pharmacological therapies, physical activity, and the management of analgesics. Patients completed questionnaires at baseline and at 3 months post-session to assess pain interference, pain intensity, and catastrophizing. RESULTS: The study population included 88 patients; 71 completed the follow-up questionnaires. Pain interference (p = 0.002), average pain intensity (p = 0.013), and catastrophizing (p < 0.001) decreased 3 months after FastSchool. At M3, 35 % of patients felt their pain had improved based on the Patient Global Impression of Change. CONCLUSION: FastSchool, an innovative short-term educational program inspired by cognitive behavioral therapy, showed positive results in reducing pain impact. PRACTICE IMPLICATIONS: Implementation of FastSchool in pain medicine departments would reduce waitlist times for non-pharmacological treatment.

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.