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ObjectivesClinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.DesignA 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.ParticipantsThirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process.Measurements and main resultsThe final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.ConclusionsThese recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.

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. [ABSTRACT FROM AUTHOR]

Purpose To compare the effects of prevention interventions on delirium occurrence in critically ill adults. Methods MEDLINE, Embase, PsychINFO, CINAHL, Web of Science, Cochrane Library, Prospero, and WHO international clinical trial registry were searched from inception to April 8, 2021. Randomized controlled trials of pharmacological, sedation, non-pharmacological, and multi-component interventions enrolling adult critically ill patients were included. We performed conventional pairwise meta-analyses, NMA within Bayesian random effects modeling, and determined surface under the cumulative ranking curve values and mean rank. Reviewer pairs independently extracted data, assessed bias using Cochrane Risk of Bias tool and evidence certainty with GRADE. The primary outcome was delirium occurrence; secondary outcomes were durations of delirium and mechanical ventilation, length of stay, mortality, and adverse effects. Results Eighty trials met eligibility criteria: 67.5% pharmacological, 31.3% non-pharmacological and 1.2% mixed pharmacological and non-pharmacological interventions. For delirium occurrence, 11 pharmacological interventions (38 trials, N = 11,993) connected to the evidence network. Compared to placebo, only dexmedetomidine (21/22 alpha.sub.2 agonist trials were dexmedetomidine) probably reduces delirium occurrence (odds ratio (OR) 0.43, 95% Credible Interval (CrI) 0.21-0.85; moderate certainty). Compared to benzodiazepines, dexmedetomidine (OR 0.21, 95% CrI 0.08-0.51; low certainty), sedation interruption (OR 0.21, 95% CrI 0.06-0.69; very low certainty), opioid plus benzodiazepine (OR 0.27, 95% CrI 0.10-0.76; very low certainty), and protocolized sedation (OR 0.27, 95% CrI 0.09-0.80; very low certainty) may reduce delirium occurrence but the evidence is very uncertain. Dexmedetomidine probably reduces ICU length of stay compared to placebo (Ratio of Means (RoM) 0.78, CrI 0.64-0.95; moderate certainty) and compared to antipsychotics (RoM 0.76, CrI 0.61-0.98; low certainty). Sedative interruption, protocolized sedation and opioids may reduce hospital length of stay compared to placebo, but the evidence is very uncertain. No intervention influenced mechanical ventilation duration, mortality, or arrhythmia. Single and multi-component non-pharmacological interventions did not connect to any evidence networks to allow for ranking and comparisons as planned; pairwise comparisons did not detect differences compared to standard care. Conclusion Compared to placebo and benzodiazepines, we found dexmedetomidine likely reduced the occurrence of delirium in critically ill adults. Compared to benzodiazepines, sedation-minimization strategies may also reduce delirium occurrence, but the evidence is uncertain., Author(s): Lisa D. Burry [sup.1] [sup.2] [sup.3], Wei Cheng [sup.4], David R. Williamson [sup.5] [sup.6], Neill K. Adhikari [sup.7] [sup.8], Ingrid Egerod [sup.9], Salmaan Kanji [sup.10] [sup.11], Claudio M. Martin [...]

Aim: To describe different patterns of communication aimed at preventing, identifying and managing symptoms between mechanically ventilated patients and clinicians in the intensive care unit. Design: We conducted a fieldwork study with triangulation of participant observation and individual interviews. Methods: Participant observation of nine patients and 50 clinicians: nurses, physiotherapists and physicians. Subsequent individual face‐to‐face interviews with nine of the clinicians, and six of the patients after they had regained their ability to speak and breathe spontaneously, were fully alert and felt well enough to sit through the interview. Findings: Symptom communication was found to be an integral part of patient care. We identified three communication patterns: (1) proactive symptom communication, (2) reactive symptom communication and (3) lack of symptom communication. The three patterns co‐existed in the cases and the first two complemented each other. The third pattern represents inadequate management of symptom distress. Conclusion: Recognition of symptoms in non‐speaking intensive care patients is an important skill for clinicians. Our study uncovered three patterns of symptom communication, two of which promoted symptom management. The third pattern suggested that clinicians did not always acknowledge the symptom distress. Implications for Patient Care: Proactive and reactive symptom assessment of non‐speaking patients require patient verification when possible. Improved symptom prevention, identification and management require a combination of sound clinical judgement and attentiveness towards symptoms, implementation and use of relevant assessment tools, and implementation and skill building in augmentative and alternative communication. Impact: This study addressed the challenges of symptom communication between mechanically ventilated patients and clinicians in the intensive care unit. Our findings may have an impact on patients and clinicians concerned with symptom management in intensive care units. Reporting Method: We used the consolidated criteria for reporting qualitative research. Patient Contribution: A user representative was involved in the design of the study. [ABSTRACT FROM AUTHOR]

Background: Opportunities for communication and participation in decision making are limited for critically ill patients, but familymembers serving as surrogates enable empowerment of these patients. Objective: The aim of this study was to explore family members' engagement in symptom communication in the intensive care unit. Methods: A qualitative descriptive design using fieldwork methodology with triangulation of participant observation and individual interviews was conducted. Nine mechanically ventilated patients were observed in interaction with family members and clinicians in the intensive care unit. Six of the observed patients, 6 family members, and 9 clinicians were interviewed after participant observation. Field notes and transcripts were analyzed using Braun and Clarke's method of thematic analysis. Results: Family members engaged actively in symptom communication, assessment, and management, and there were barriers and facilitators to family engagement. Three main themes and 9 subthemes describing family engagement emerged: (1) intermediary role (recognize and report symptoms, provide patient information, and assist in communication), (2) independent role (provide familiarity, manage symptoms, and promote patient communication), and (3) conditions for family engagement (intensive care unit environment, relationship with the patient, and patient preferences). Discussion: Familymembers have unique knowledge of the patient that differs from and complement the competence of the staff, and might contribute to improved symptom communication. Future research should examine how family members can contribute to symptom communication, assessment, and management. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aim: To understand the content and context of a realized peer mentor intervention, and to explore how mentors and mentees experienced the intervention. Design: The study was designed as a qualitative process evaluation of a 24-week peer mentor intervention. Methods: Semi-structured individual interviews were conducted from November 2021 to May 2022 in a purposeful sample of older vulnerable people with ischemic heart disease, referred to as mentees (n = 13), and their peer mentors (n = 12). Thematic analysis was used to analyse, categorize and interpret interview data. Results: Five themes captured the content and context of the peer mentor intervention as experienced by mentors and mentees. 'Takes one to know one', stressing the importance of the mentor--mentee matching process; 'Varying demand for mentors', illustrating the difficulties in predicting who has the greatest need for mentoring; 'Varying degree of familiarity', describing the mentor--mentee relationship as a continuum from formal mentor to informal friend; 'Putting the patient first', illustrating how mentors support mentees based on their personal experiences of successful recovery while letting the mentee set the pace and goals; and 'Varying view of success', showing how intervention success is perceived differently by mentors and mentees. Conclusions: The study provides new knowledge on how and under what contextual circumstances a mentor intervention works. These findings are important for the implementation of future peer mentor interventions to achieve successful peer mentor support. Implications and Impact: Non-attendance and drop-out from the cardiac rehabilitation program are prevalent problems among older vulnerable people with cardiovascular disease. This study describes a low-cost peer mentor intervention that can support this group of patients. Reporting Method: Standards for reporting qualitative research (SRQR) guided our study. Patient or Public Contribution: A board of cardiovascular patients have contributed to the development and implementation of the intervention being evaluated. [ABSTRACT FROM AUTHOR]