A Core Outcome Set for Research Evaluating Interventions to Enable Communication in Patients With an Artificial Airway: An International Delphi Consensus Study (Comm-COS).

OBJECTIVES: Critically ill adults requiring artificial airways experience profound communication deficits. Studies of interventions supporting communication report disparate outcomes, creating subsequent challenges in the interpretation of their effectiveness. Therefore, we aimed to develop international consensus for a communication core outcome set (Comm-COS) for future trials of communication interventions in this population. DESIGN: 1) Systematic review, 2) patient/family interviews, 3) two-round modified Delphi, and 4) virtual consensus meetings with a final voting round. A multidisciplinary expert steering committee oversaw all stages. SETTING: Interviews and consensus meetings were conducted via videoconferencing. Digital methods were used for Delphi and final Comm-COS voting. SUBJECTS: Three stakeholder groups: 1) patient and family members with lived experience within 3 years, 2) clinicians with experience working in critical care, and 3) researchers publishing in the field. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: We identified 59 outcomes via our systematic review, 3 unique outcomes from qualitative interviews, and 2 outcomes from our steering committee. Following item reduction, 32 outcomes were presented in Delphi round 1; 134 participants voted; 15 patient/family (11%), 91 clinicians (68%), and 28 researchers (21%). Nine additional outcomes were generated and added to round 2; 106 (81%) participants voted. Following completion of the consensus processes, the Comm-COS includes seven outcomes: 1) changes in emotions and wellbeing associated with ability to communicate, 2) physical impact of communication aid use, 3) time to functional communication, 4) ability to communicate healthcare needs (comfort/care/safety/decisions), 5) conversation agency, 6) ability to establish a communication connection to develop and maintain relationships, and 7) acceptability of the communication intervention. CONCLUSIONS: This is the first COS to specifically focus on communication for critically ill adults. Limitations for operationalization include selection of measures to use with these outcomes. Identification of suitable measures and adoption of the Comm-COS in future trials will help establish effective interventions to ameliorate the highly prevalent and negative experience of communicative incapacity.

A rare form of metastatic breast carcinoma mimicking lymphangioma circumscriptum.

Cutaneous metastasis is rare but may indicate an advanced internal malignancy or a recurrence of a previously treated one and is usually associated with a poor prognosis. They may also pose a diagnostic problem as the clinical manifestations are variable and non-specific, which could mimic other benign conditions. We report a case of a 48-year-old female who presented with a 4-year history of erythematous papules and vesicles on the trunk mimicking lymphangioma circumscriptum. Skin biopsy and immunohistochemistry were consistent with cutaneous metastasis from breast carcinoma. Cutaneous metastasis presents in a variety of patterns. A high index of suspicion and a low threshold for skin biopsy are paramount to the early diagnosis and treatment. A histopathologic evaluation will help identify the origin of the cutaneous metastasis and can significantly affect the outcome of the treatment.

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.

Two-year prospective cohort of intensive care survivors enrolled on a digitally enabled recovery pathway focussed on individualised recovery goal attainment.

BACKGROUND: Despite substantial evidence documenting physical, psychological, and cognitive problems experienced by intensive care unit (ICU) survivors, few studies explore interventions supporting recovery after hospital discharge. Individualised recovery goal setting, the standard of care across many rehabilitation areas, is rarely used for ICU survivors. Digital health technologies may help to address current service fragmentation and gaps. We developed and implemented a digital ICU recovery pathway using the aTouchaway e-health platform. OBJECTIVES: The objective of this study was to explore recovery barriers and challenges; recovery goals set and achieved; self-reported patient outcomes; and healthcare costs of patients enrolled on a 12-week digital ICU recovery pathway after hospital discharge. METHODS: We conducted a prospective observational single-centre cohort study (June 2021 to May 2023) at a 90-bed tertiary critical care service in London, UK. We enrolled adults ventilated for ≥3 days who were able to participate in recovery activities. We ascertained baseline recovery challenges and identified recovery goals and achievement over 12 weeks. We collected patient-reported outcomes at 2-4, 12-14, 26-28 weeks and healthcare utilisation monthly for 28 weeks. RESULTS: We enrolled 105 participants (35% of eligible patients). Common rehabilitation challenges were standing balance (60%), walking indoors (56%), and washing (64%) and dressing (47%) abilities. Of 522 home recovery goals, 63% weekly, 48% monthly, and 38% aspirational goals were achieved. Most goals related to self-care: ability to move outside (91 goals, 55% achieved) and inside (45 goals, 47% achieved) the home and community access (65 goals, 48% achieved). Nottingham Extended Activities of Daily Living Scale scores improved from timepoints 1 to 2 (median [interquartile range]: 15 [7, 19] versus 19 [15, 21], P = 0.01). Total healthcare costs were £240,017 (median [interquartile range] cost per patient: £784 [£125, £4419]). CONCLUSIONS: This study found multiple ongoing functional deficits, challenges achieving recovery goals, and limited improvements in self-reported outcomes, with moderate healthcare costs after hospital discharge indicate substantial ongoing rehabilitative needs.

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.

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.

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.

Healthcare Utilization and Costs in Children Receiving Home Mechanical Ventilation in Ontario: A 14-Year Cohort Study.

RATIONALE: Home mechanical ventilation (HMV) is an advanced medical therapy offered to children with medical complexity. Despite the growing pediatric HMV population in North America, there are limited studies describing healthcare utilization and predictors of highest costs using robust health administrative data. OBJECTIVES: To describe patterns of healthcare utilization and costs in children receiving HMV over a 14-year period in Ontario, Canada. METHODS: We conducted a retrospective population-based cohort study (April 1, 2003 to March 31, 2017) of children aged 0-18 years receiving HMV via invasive mechanical ventilation (IMV) or non-invasive ventilation (NIV). Paired t-tests compared healthcare system utilization and costs two years before and two years after HMV approval. We developed linear models to analyze variables associated with children in the top quartile of health service utilization and costs. RESULTS: We identified 835 children receiving HMV. In the two years after HMV approval compared to the 2 years prior, children had decreased hospitalization days (median 9 (IQR 3-30) versus 29 (6-99), p<0.0001) and ICU admission days (6.6 (1.9-18.0) versus 17.1 (3.3-70.9), p<0.0001) but had increased homecare service approvals (195 (24-522) versus 40 (12-225), p<0.0001) and outpatient Pulmonology visits (3 (1-4) versus 2 (1-3), p<0.0001). Total healthcare costs were higher in the two years after HMV approval (mean $164,892 (SD $214,187) versus $128,941 ($194,199), p<0.0001). However, all-cause hospital admission costs were reduced ($66,546 ($142,401) versus $81,578 ($164,672), p<0.0001). Highest total 2-year costs were associated with IMV (OR 3.45, 95% CI 2.24-5.31; reference NIV), number of medical devices at home (OR 1.63, 95% CI 1.35-1.96; reference no technology), and increased healthcare costs in the year prior to HMV initiation (OR 2.23, 95% CI 1.84-2.69). CONCLUSIONS: Children progressing to the need for HMV represent a worsening in their respiratory status that will undoubtedly increase healthcare utilization and costs. We found that the initiation of HMV in these children can reduce inpatient healthcare utilization and costs but can still increase overall healthcare expenditures, especially in the outpatient setting.

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 an intergenerational program to improve loneliness and social isolation in older adults initiated at the time of emergency department discharge: study protocol for a three-arm randomized clinical trial.

BACKGROUND: Social isolation and loneliness (SIL) worsens mortality and other outcomes among older adults as much as smoking. We previously tested the impact of the HOW R U? intervention using peer support from similar-aged volunteers and demonstrated reduced SIL among older adults discharged from the emergency department (ED). Generativity, defined as "the interest in establishing and guiding the next generation," can provide an alternative theoretical basis for reducing SIL via intergenerational programs between members of younger and older generations. The current protocol will examine the impact of younger intergenerational volunteers providing the HOW RU? METHODS: In this randomized clinical trial, we will compare the following three arms: (1) the standard same-generation peer support HOW R U? intervention, (2) HOW R U? intervention delivered by intergenerational volunteers, and (3) a common wait-list control group. Outcome assessors will be blinded to the intervention. Trained volunteers will deliver 12 weekly telephone support calls. We will recruit participants ≥ 70 years of age with baseline loneliness (six-item De Jong loneliness score of 2 or greater) from two EDs. Research staff will assess SIL, depression, quality of life, functional status, generativity, and perceived benefit at baseline, at 12 weeks, and 24 weeks post-intervention. DISCUSSION: We hypothesize participants receiving the intergenerational intervention will show improved outcomes compared to the control group and peer support HOW R U? INTERVENTION: We also hypothesize that participants with higher perceptions of generativity will have greater reductions in SIL than their lower generativity counterparts. Aging is experienced diversely, and social interventions combatting associated SIL should reflect that diversity. As part of a program of research following the Obesity-Related Behavioral Intervention Trials (ORBIT) model, the findings of this RCT will be used to define which intervention characteristics are most effective in reducing SIL. TRIAL REGISTRATION: ClinicalTrials.gov NCT05998343 Protocol ID:21-0074E. Registered on 24 July 2023.

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.

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults 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. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are 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 preventing and treating multimorbidity in adults 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 (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. 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 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 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 adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs. PROSPERO REGISTRATION NUMBER: CRD42020197293.