Left ventricular unloading in patients supported with veno-arterial extra corporeal membrane oxygenation; an international EuroELSO survey.

INTRODUCTION: Veno-arterial extracorporeal membrane oxygenation (V-A ECMO) improves end-organ perfusion in cardiogenic shock but may increase afterload, which can limit cardiac recovery. Left ventricular (LV) unloading strategies may aid cardiac recovery and prevent complications of increased afterload. However, there is no consensus on when and which unloading strategy should be used. METHODS: An online survey was distributed worldwide via the EuroELSO newsletter mailing list to describe contemporary international practice and evaluate heterogeneity in strategies for LV unloading. RESULTS: Of 192 respondents from 43 countries, 53% routinely use mechanical LV unloading, to promote ventricular recovery and/or to prevent complications. Of those that do not routinely unload, 65% cited risk of complications as the reason. The most common indications for unplanned unloading were reduced arterial line pulsatility (68%), pulmonary edema (64%) and LV dilatation (50%). An intra-aortic balloon pump was the most frequently used device for unloading followed by percutaneous left ventricular assist devices. Echocardiography was the most frequently used method to monitor the response to unloading. CONCLUSIONS: Significant variation exists with respect to international practice of ventricular unloading. Further research is required that compares the efficacy of different unloading strategies and a randomized comparison of routine mechanical unloading versus unplanned unloading.

Direct Health Care Costs Associated With a Multicomponent COPD Exacerbation Intervention.

BACKGROUND: Health care costs attributed to COPD have been estimated at $4.7 trillion globally in the next 30 years. With the global burden of COPD rising, identification of interventions that might lead to health care cost savings is an imperative. Although many studies report the effect of COPD self-management interventions on subject outcomes and health care utilization, few data describe their effect on health care costs. METHODS: Using data linkage and established case-costing methods with provincial Canadian health databases, we established public health care costs (acute and community) for 12 months following randomization for the 462 participants enrolled in our randomized controlled trial of the Program of Integrated Care for Patients with COPD and Multiple Comorbidities. RESULTS: Total median (interquartile range) in-hospital costs in the 12 months follow-up for all (intervention and control) 462 trial participants were CAD $4,769 ($417-16,834) (equivalent to US $3,566 [$312-12,588]). Total costs incurred in the community were higher at CAD $8,011 ($4,749-13,831) (equivalent to US $5,990 [$3,551-10,342]). Controlling for sex, income quintile, Johns Hopkins Aggregated Diagnosis Groups score, and living in an urban locality, we found lower community health care costs but no differences in acute care costs for participants receiving our multicomponent COPD exacerbation prevention management intervention compared to usual care. CONCLUSIONS: Controlling for important confounders, we found lower public community health care costs but no difference in acute health care costs with our multicomponent COPD exacerbation prevention management intervention compared to usual care. Community health care costs were almost double those incurred compared to acute health care costs. Given this finding, although most COPD exacerbation management interventions generally focus on reducing the use of acute care, interventions that enable health care cost savings in the community require further exploration.

Prolonged Mechanical Ventilation, Weaning, and the Role of Tracheostomy.

Depending on the definitional criteria used, approximately 5% to 10% of critical adults will require prolonged mechanical ventilation with longer-term outcomes that are worse than those ventilated for a shorter duration. Outcomes are affected by patient characteristics before critical illness and its severity but also by organizational characteristics and care models. Definitive trials of interventions to inform care activities, such as ventilator weaning, upper airway management, rehabilitation, and nutrition specific to the prolonged mechanical ventilation patient population, are lacking. A structured and individualized approach developed by the multiprofessional team in discussion with the patient and their family is warranted.

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in low- and middle-income countries: the COSMOS study.

Introduction: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. A core outcome set (COS) appropriate for the study of multimorbidity in LMIC contexts does not presently exist. This is required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at the prevention and treatment of multimorbidity in LMICs. Methods: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups with representation from 33 countries (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals, and policy makers). Consensus meetings were used to reach agreement on the two final COS. Registration: https://www.comet-initiative.org/Studies/Details/1580. Results: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention, and six treatment outcomes were added from Delphi round one. Delphi round two surveys were completed by 95 of 132 round one participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) Adverse events, (2) Development of new comorbidity, (3) Health risk behaviour, and (4) Quality of life; and four for the treatment COS: (1) Adherence to treatment, (2) Adverse events, (3) Out-of-pocket expenditure, and (4) Quality of life. Conclusion: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.

Acceptability of the Long-Term In-Home Ventilator Engagement virtual intervention for home mechanical ventilation patients during the COVID-19 pandemic: A qualitative evaluation.

Background: Clinical management of ventilator-assisted individuals (VAIs) was challenged by social distancing rules during the COVID-19 pandemic. In May 2020, the Long-Term In-Home Ventilator Engagement (LIVE) Program was launched in Ontario, Canada to provide intensive digital care case management to VAIs. The purpose of this qualitative study was to explore the acceptability of the LIVE Program hosted via a digital platform during the COVID-19 pandemic from diverse perspectives. Methods: We conducted a qualitative descriptive study (May 2020-April 2021) comprising semi-structured interviews with participants from eight home ventilation specialty centers in Ontario, Canada. We purposively recruited patients, family caregivers, and providers enrolled in LIVE. Content analysis and the theoretical concepts of acceptability, feasibility, and appropriateness were used to interpret findings. Results: A total of 40 individuals (2 VAIs, 18 family caregivers, 20 healthcare providers) participated. Participants described LIVE as acceptable as it addressed a longstanding imperative to improve care access, ease of use, and training provided; feasible for triaging problems and sharing information; and appropriate for timeliness of provider responses, workflows, and perceived value. Negative perceptions of acceptability among healthcare providers concerned digital workload and fit with existing clinical workflows. Perceived benefits accorded to LIVE included enhanced physical and psychological safety in the home, patient-provider relations, and VAI engagement in their own care. Conclusions: Study findings identify factors influencing the LIVE Program's acceptability by patients, family caregivers, and healthcare providers during pandemic conditions including enhanced access to care, ease of case management triage, and VAI safety. Findings may inform the implementation of digital health services to VAIs in non-pandemic circumstances.

Impact of a peer-support programme to improve loneliness and social isolation due to COVID-19: does adding a secure, user friendly video-conference solution work better than telephone support alone? Protocol for a three-arm randomised clinical trial.

INTRODUCTION: The COVID-19 pandemic has forced the implementation of physical distancing and self-isolation strategies worldwide. However, these measures have significant potential to increase social isolation and loneliness. Among older people, loneliness has increased from 40% to 70% during COVID-19. Previous research indicates loneliness is strongly associated with increased mortality. Thus, strategies to mitigate the unintended consequences of social isolation and loneliness are urgently needed. Following the Obesity-Related Behavioural Intervention Trials model for complex behavioural interventions, we describe a protocol for a three-arm randomised clinical trial to reduce social isolation and loneliness. METHODS AND ANALYSIS: A multicentre, outcome assessor blinded, three-arm randomised controlled trial comparing 12 weeks of: (1) the HOspitals WoRking in Unity ('HOW R U?') weekly volunteer-peer support telephone intervention; (2) 'HOW R U?' deliver using a video-conferencing solution and (3) a standard care group. The study will follow Consolidated Standard of Reporting Trials guidelines.We will recruit 24-26 volunteers who will receive a previously tested half day lay-training session that emphasises a strength-based approach and safety procedures. We will recruit 141 participants ≥70 years of age discharged from two participating emergency departments or referred from hospital family medicine, geriatric or geriatric psychiatry clinics. Eligible participants will have probable baseline loneliness (score ≥2 on the de Jong six-item loneliness scale). We will measure change in loneliness, social isolation (Lubben social network scale), mood (Geriatric Depression Score) and quality of life (EQ-5D-5L) at 12-14 weeks postintervention initiation and again at 24-26 weeks. ETHICS AND DISSEMINATION: Approval has been granted by the participating research ethics boards. Participants randomised to standard care will be offered their choice of telephone or video-conferencing interventions after 12 weeks. Results will be disseminated through journal publications, conference presentations, social media and through the International Federation of Emergency Medicine. TRIAL REGISTRATION NUMBER: NCT05228782.

Airway pressure release ventilation for lung protection in acute respiratory distress syndrome: an alternative way to recruit the lungs.

PURPOSE OF REVIEW: Airway pressure release ventilation (APRV) is a modality of ventilation in which high inspiratory continuous positive airway pressure (CPAP) alternates with brief releases. In this review, we will discuss the rationale for APRV as a lung protective strategy and then provide a practical introduction to initiating APRV using the time-controlled adaptive ventilation (TCAV) method. RECENT FINDINGS: APRV using the TCAV method uses an extended inspiratory time and brief expiratory release to first stabilize and then gradually recruit collapsed lung (over hours/days), by progressively 'ratcheting' open a small volume of collapsed tissue with each breath. The brief expiratory release acts as a 'brake' preventing newly recruited units from re-collapsing, reversing the main drivers of ventilator-induced lung injury (VILI). The precise timing of each release is based on analysis of expiratory flow and is set to achieve termination of expiratory flow at 75% of the peak expiratory flow. Optimization of the release time reflects the changes in elastance and, therefore, is personalized (i.e. conforms to individual patient pathophysiology), and adaptive (i.e. responds to changes in elastance over time). SUMMARY: APRV using the TCAV method is a paradigm shift in protective lung ventilation, which primarily aims to stabilize the lung and gradually reopen collapsed tissue to achieve lung homogeneity eliminating the main mechanistic drivers of VILI.

Clinician-perceived barriers and facilitators for the provision of actionable processes of care important for persistent or chronic critical illness.

AIM: To explore clinician-perceived barriers to and facilitators for the provision of actionable processes of care important for patients with persistent or chronic critical illness. DESIGN: Qualitative descriptive interview study. METHODS: Secondary analysis of semi-structured telephone interviews (December 2018 - February 2019) with professionally diverse clinicians working with adults experiencing persistent or chronic critical illness in Canadian intensive care units. We used deductive content analysis informed by the Social-Ecological Model. RESULTS: We recruited 31 participants from intensive care units across nine Canadian provinces. Reported intrapersonal level barriers to the provision of actionable processes of care included lack of training, negative emotions and challenges prioritizing these patients. Facilitators included establishment of positive relations and trust with patients and family. Interpersonal barriers included communication difficulties, limited access to physicians and conflict. Facilitators included communication support, time spent with the patient/family and conflict management. Institutional barriers comprised inappropriate care processes, inadequate resources and disruptive environmental conditions. Facilitators were regular team rounds, appropriate staffing and employment of a primary care (nurse and/or physician) model. Community-level barriers included inappropriate care location and insufficient transition support. Facilitators were accessed to alternate care sites/teams and to formalized transition support. Public policy-level barriers included inadequacy of formal education programs for the care of these patients; knowledge implementation for patient management was identified as a facilitator. CONCLUSION: Our results highlighted multilevel barriers and facilitators to the delivery of actionable processes important for quality care for patient/family experiencing persistent or chronic critical illness. IMPACT: Using the Social-Ecological Model, the results of this study provide intra and interpersonal, institutional, community and policy-level barriers to address and facilitators to harness to improve the care of patients/family experiencing persistent or chronic critical illness. REPORTING METHOD: Consolidated criteria for reporting qualitative studies. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Development, feasibility testing, and preliminary evaluation of the Communication with an Artificial airway Tool (CAT): Results of the Crit-CAT pilot study.

BACKGROUND: A purpose-built outcome measure for assessing communication effectiveness in patients with an artificial airway is needed. OBJECTIVES: The objective of this study was to develop the Communication with an Artificial airway Tool (CAT) and to test the feasibility and to preliminary evaluate the clinical metrics of the tool. METHODS: Eligible patients with an artificial airway in the Intensive Care Unit were enrolled in the pilot study (Crit-CAT). The CAT was administered at least twice before and after the communication intervention. Item correlation analysis was performed. Participant and family member acceptability ratings and feedback were solicited. A qualitative thematic analysis was undertaken. RESULTS: Fifteen patients with a mean age of 53 years (standard deviation [SD]: 19.26) were included. The clinician-reported scale was administered on 50 attempts (100%) with a mean completion time of 4.5 (SD: 0.77) minutes. The patient-reported scale was administered on 46 out of 49 attempts (94%) and took a mean of 1.5 (SD: 0.39) minutes to complete. The CAT was feasible for use in the Intensive Care Unit, with patients with either an endotracheal or tracheostomy tube, whilst receiving invasive mechanical ventilation or not, and while using either verbal or nonverbal modes of communication. Preliminary establishment of responsiveness, validity, and reliability was made. The tool was acceptable to participants and their family members. CONCLUSION: The clinician-reported and patient-reported components of the study were feasible for use. The CAT has the potential to enable quantifiable comparison of communication interventions for patients with an artificial airway. Future research is required to determine external validity and reliability.

An environmental scan of online resources for informal family caregivers of ICU survivors.

PURPOSE: To collate a comprehensive repository of online resources for family caregivers of intensive care survivors to inform a recovery website and digital peer support programme. MATERIALS AND METHODS: To identify resources, we conducted an environmental scan using processes recommended by the Canadian Agency for Drugs and Technologies in Health and guided by clinical experts, former patients, and family members. We searched internet sources, professional society websites, social media, and contacted our professional networks. RESULTS: Through expert consultation we identified 16 information categories and found 301 online resources. Five categories with the most resources were: how to look after yourself/recognise anxiety or post-traumatic stress/getting mental health support (n = 63); information specific to conditions necessitating ICU admission (n = 49); multiple category resources (n = 46); symptoms of post-intensive care syndrome (n = 44); stories of lived experience (n = 23). Five categories with the least resources were physical, emotional and cognitive symptoms of post-intensive care syndrome-family (n = 1); interacting with primary care (n = 2); medical deterioration (how to recognise/what to do) (n = 2); driving and accessing the community (n = 3); end-of-life and bereavement (n = 5). Of these resources, we included 45 on our recovery website. CONCLUSION: This environmental scan identifies multiple resources addressing informational needs of family caregivers and highlights areas for resource development.

Opening the digital front door for individuals using long-term in-home ventilation (LIVE) during a pandemic- implementation, feasibility and acceptability.

Background: The COVID-19 pandemic led to an unprecedented need for virtual healthcare that was safe, acceptable and feasible to deliver. In May 2020, we launched the Long-term In-Home Ventilator Engagement (LIVE) program for ventilator assisted individuals using ventilators hosted on an e-platform in Ontario, Canada. Objectives: To assess the acceptability, appropriateness, feasibility and usability of the LIVE program reported by patients, family caregivers, and healthcare providers (HCP). Design and Methods: We conducted a cross-sectional study. We provided HCPs participating in the LIVE program anonymized questionnaires (Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), and mHealth App Usability (MAUQ). Patients and family caregivers completed the AIM and MAUQ. Questionnaires were administered via an e-platform. Results: We recruited 105/251 (42%) patients and family caregivers and 42/48 (87.5%) HCPs. Patients and caregivers rated a mean (SD) overall AIM score of 4.3 (0.7) (maximum score 5; higher scores indicate greater acceptability) and a mean (SD) overall MAUQ score of 5.8 (1.5) (maximum score 7; higher scores indicate greater useability). HCPs rated a mean (SD) overall AIM score of 4.3 (0.7), IAM score of 4.3 (0.8), FIM score of 4.2 (0.7) and overall MAUQ score of 5.6 ± 1.5. There were no differences in AIM ((4.3 (0.7) vs 4.3 (0.8), p = 1) or MAUQ (5.8 (1.5) vs 5.6 (1.5), p = 0.5) scores between patients/ family caregivers and HCPs. Interpretation: This study suggests that the LIVE program was acceptable, appropriate, feasible, and usable from the perspective of patients, family caregivers and HCPs.

Adapting co-design methodology to a virtual environment: co-designing a communication intervention for adult patients in critical care.

BACKGROUND: Research co-design is recommended to reduce misalignment between researcher and end-user needs and priorities for healthcare innovation. Engagement of intensive care unit patients, clinicians, and other stakeholders in co-design has historically relied upon face-to-face meetings. Here, we report on our co-design processes for the development of a bundled intensive care unit patient communication intervention that used exclusively virtual meeting methods in response to COVID-19 pandemic social distancing restrictions. METHODS: We conducted a series of virtual co-design sessions with a committee of stakeholder participants recruited from a medical-surgical intensive care unit of a community teaching hospital in Toronto, Canada. Published recommendations for co-design methods were used with exclusively virtual adaptations to improve ease of stakeholder participation as well as the quality and consistency of co-design project set-up, facilitation, and evaluation. Virtual adaptations included the use of email for distributing information, videos, and electronic evaluations as well as the use of a videoconferencing platform for synchronous meetings. We used a flexible meeting plan including asynchronous virtual methods to reduce attendance barriers for time-constrained participants. RESULTS: Co-design participants included a patient and a family member (n = 2) and professionally diverse healthcare providers (n = 9), plus a facilitator. Overall, participants were engaged and reported a positive experience with the virtually adapted co-design process. Reported benefits included incorporation of diverse viewpoints in the communication intervention design and implementation plan. Challenges related to lack of hands-on time during development of the co-designed intervention and participant availability to meet regularly albeit virtually. CONCLUSIONS: This report describes the methods, benefits, and challenges of adapting in-person co-design methods to a virtual environment to produce a bundled communication intervention for use in the adult intensive care unit during the COVID-19 pandemic. Adapting recommended co-design methods to a virtual environment can provide further opportunities for stakeholder participation in intervention design.

Exploring factors affecting the timely transition of ventilator assisted individuals in Ontario from acute to long-term care: Perspectives of healthcare professionals.

Rationale: Ventilator Assisted Individuals (VAIs) frequently remain in intensive care units (ICUs) for a prolonged period once clinically stable due to a lack of transition options. These VAIs occupy ICU beds and resources that patients with more acute needs could better utilize. Moreover, VAIs experience improved outcomes and quality of life in long-term and community-based environments. Objective: To better understand the perspectives of healthcare providers (HCPs) working in an Ontario ICU regarding barriers and facilitators to referral and transition of VAIs from the ICU to a long-term setting. Methods: We conducted semi-structured interviews with ten healthcare providers involved in VAI transitions. Main Results: Perceived barriers included long wait times for long-term care settings, insufficient bed availability at discharge locations, medical complexity of patients, long waitlists, and a lack of transparency of waitlists. Facilitators included strong partnerships and trusting relationships between referring and discharge locations, a centralized referral system, and utilization of community partnerships across care sectors. Conclusions: Insufficient resourcing of long-term care is a key barrier to transitioning VAIs from ICU to long-term settings; strong partnerships across care sectors are a facilitator. System-level approaches, such as a single-streamlined referral system, are needed to address key barriers to timely transition.

Clinical impact of screening computed tomography in extracorporeal membrane oxygenation: a retrospective cohort study.

BACKGROUND: Data on the prevalence and clinical impact of extrapulmonary findings at screening computed tomography (CT) on initiation of veno-venous extracorporeal membrane oxygenation (V-V ECMO) are limited. We aimed to identify the prevalence of extrapulmonary findings on screening CT following V-V ECMO initiation. We hypothesized that extrapulmonary findings would influence clinical management and outcome. METHODS: Retrospective analysis (2011-2021) of admission screening CT including head, abdomen and pelvis with contrast of consecutive patients on initiation of V-V ECMO. CT findings identified by the attending consultant radiologist were extracted. Demographics, admission physiological and laboratory data, clinical decision-making following CT and ECMO ICU mortality were recorded from the electronic medical record. We used multivariable logistic regression and Kaplan-Meier curves to evaluate associations between extrapulmonary findings and ECMO ICU mortality. RESULTS: Of the 833 patients receiving V-V ECMO, 761 underwent routine admission CT (91.4%). ECMO ICU length of stay was 19 days (IQR 12-23); ICU mortality at the ECMO centre was 18.9%. An incidental extrapulmonary finding was reported in 227 patients (29.8%), leading to an invasive procedure in 12/227 cases (5.3%) and a change in medical management (mainly in anticoagulation strategy) in 119/227 (52.4%). Extrapulmonary findings associated with mortality were intracranial haemorrhage (OR 2.34 (95% CI 1.31-4.12), cerebral infarction (OR 3.59 (95% CI 1.26-9.86) and colitis (OR 2.80 (95% CI 1.35-5.67). CONCLUSIONS: Screening CT frequently identifies extrapulmonary findings of clinical significance. Newly detected intracranial haemorrhage, cerebral infarction and colitis were associated with increased ICU mortality.

Digital solutions and the future of recovery after critical illness.

PURPOSE OF REVIEW: Digital technologies may address known physical and psychological barriers to recovery experienced by intensive care survivors following hospital discharge and provide solutions to care fragmentation and unmet needs. The review highlights recent examples of digital technologies designed to support recovery of survivors of critically illness. RECENT FINDINGS: Despite proliferation of digital technologies supporting health in the community, there are relatively few examples for intensive care survivors. Those we identified included web-based, app-based or telemedicine-informed recovery clinics or pathways offering services, including informational resources, care planning and navigation support, medication reconciliation, and recovery goal setting. Digital interventions supporting psychological recovery included apps providing adaptive coping skills training, mindfulness, and cognitive behavioural therapy. Efficacy data are limited, although feasibility and acceptability have been established for some. Challenges include difficulties identifying participants most likely to benefit and delivery in a format easily accessible to all, with digital exclusion a resultant risk. SUMMARY: Digital interventions supporting recovery comprise web or app-based recovery clinics or pathways and digital delivery of psychological interventions. Understanding of efficacy is relatively nascent, although several studies demonstrate feasibility and acceptability. Future research is needed but should be mindful of the risk of digital exclusion.

Mechanical insufflation-exsufflation to promote extubation success in critically ill adults on intensive care: protocol for a randomised controlled feasibility trial.

BACKGROUND: Extubation failure, defined as reintubation within 48 h, is associated with increased intensive care unit (ICU) length of stay and higher mortality risk. One cause of extubation failure is secretion retention, resulting from an inability to cough effectively. Mechanical insufflation-exsufflation (MI-E) simulates a cough aiding secretion clearance. However, MI-E is not routinely used in the ICU for invasively ventilated patients. This study aims to determine feasibility and acceptability of a randomised controlled trial (RCT) examining MI-E use to promote extubation success in intubated, ventilated adults. METHODS: It is a single-centre, feasibility RCT with semi-structured interviews, economic scoping, and exploratory physiology study. The feasibility RCT (n = 50) will compare standard care to a MI-E protocol including a minimum of two MI-E sessions via the endotracheal tube prior to extubation. Post-extubation, MI-E will be delivered via facemask or mouthpiece up to two times/day for 48 h. MI-E settings will be individualised. All patients will receive standard care (no MI-E) in relation to mechanical ventilation, weaning, rehabilitation, physiotherapy techniques such as positioning, manual airway clearance techniques, manual/ventilator hyperinflation, endotracheal suctioning, and nebulisation. Clinical data collection will occur before, on completion, and 5-min post-physiotherapy sessions (intervention/control arms). Resource use will be calculated for each 24-h period. Analyses will be descriptive and address feasibility outcomes including participant recruitment and attrition, proportion of MI-E treatment sessions completed, dataset completeness, and frequency of adverse events and acceptability. Semi-structured online interviews informed by the Theoretical Framework of Acceptability (TFA) with patients, clinicians, and family members will explore the acceptability of the MI-E intervention and study processes. Interview data will be analysed using reflexive thematic analysis based on TFA domains through first-level coding. The embedded physiology study will use electrical impedance tomography and lung ultrasound to explore lung recruitment and de-recruitment during MI-E in a subset of 5-10 patients. DISCUSSION: This study will examine feasibility and acceptability of a RCT protocol of MI-E to promote extubation success. Study findings will inform design modification and conduct of a future adequately powered trial. Furthermore, the study will contribute and advance the understanding of MI-E use in critically ill intubated adults. TRIAL REGISTRATION: ISRCTN 24603037; IRAS 303674.

Development of a menu of recovery goals to facilitate goal setting after critical illness.

OBJECTIVE: To develop an expert-informed (including end users) recovery goal menu for adults recovering from critical illness applicable to the community/home setting. RESEARCH METHODOLOGY/DESIGN: Stage 1 Item generation: iterative development of domains, sub-domains, and goals in consultation with former intensive care patients, family members and expert clinicians. Stage 2 Content validity assessment: cognitive interviews and the content validity index. SETTING: Virtual consultation meetings facilitated by the research team at King's College London and Guy's and St Thomas' NHS Foundation Trust. MAIN OUTCOME MEASURES: Content validity as assessed by: the Item-Content Validity Index (I-CVI), Scale Level-Content Validity Index/Universal Agreement (S-CVI/UA) score, the Scale Level-Content Validity Index/Average (S-CVI/Ave) score and Average Content Validity Ratio (CVR). RESULTS: Item generation resulted in a goal menu comprising 4 domains, 22 sub-domains and 95 goals assigned as follows: Self-care: 9 sub-domains with 37 goals, Productivity: 7 sub-domains with 13 goals, Leisure: 3 sub-domains with 25 goals, and Person domain 3 sub-domains with 20 goals. Cognitive interviews resulted in addition of 79 goals and modification of 7, addition of 4 new sub-domains and modification of 4, thus resulting in 4 domains, 26 sub-domains with a total of 174 goals. Twenty-four sub-domains (169 goals) were deemed relevant with Item-Content Validity Index (I-CVI) scores ranging from 0.72 to 1. Two sub-domains (5 goals) did not meet the 0.7 cut-off and were removed. The Scale Level-Content Validity Index/Universal Agreement (S-CVI/UA) score was 0.46; the Scale Level-Content Validity Index/Average (S-CVI/Ave) 0.91. Average Content Validity Ratio (CVR) was 0.93. CONCLUSION: An expert informed recovery goal menu for former intensive care patients has been developed with excellent content validity. The final goal menu comprises 169 goals within 24 sub-domains grouped under 4 domains. IMPLICATIONS FOR CLINICAL PRACTICE: This menu will help patients to set goals and increase our understanding of how individuals recover from critical illness.

A Core Outcome Set for Interventions to Prevent and/or Treat Delirium in Palliative Care.

CONTEXT: Delirium is a serious neurocognitive syndrome which is highly prevalent in people approaching the end of life. Existing trials of interventions to prevent or treat delirium in adults receiving palliative care report heterogeneous outcomes. OBJECTIVES: To undertake an international consensus process to develop a core outcome set for trials of interventions, designed to prevent and/or treat delirium, for adults receiving palliative care. METHODS: The core outcome set development process included a systematic review, qualitative interviews, modified Delphi method and virtual consensus meetings using nominal group technique (Registration http://www.comet-initiative.org/studies/details/796). Participants included family members, clinicians, and researchers with experience of delirium in palliative care. RESULTS: Forty outcomes were generated from the systematic review and interviews informing the Delphi Round one survey. The international Delphi panel comprised 92 participants including clinicians (n = 71, 77%), researchers (n = 13, 14%), and family members (n = 8, 9%). Delphi Round two was completed by 77 (84%) participants from Round one. Following the consensus meetings, four outcomes were selected for the core outcome set: 1) delirium occurrence (incidence and prevalence); 2) duration of delirium until resolution defined as either no further delirium in this episode of care or death; 3) overall delirium symptom profile (agitation, delusions or hallucinations, delirium symptoms and delirium severity); 4) distress due to delirium (person with delirium, and/or family and/or carers [including healthcare professionals]). CONCLUSION: Using a rigorous consensus process, we developed a core outcome set comprising four delirium-specific outcomes for inclusion in future trials of interventions to prevent and/or treat delirium in palliative care.