559 results on '"Needham DM"'
Search Results
52. The importance of understanding the costs of critical care and mechanical ventilation.
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Needham DM, Pronovost PJ, Needham, Dale M, and Pronovost, Peter J
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- 2005
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53. Interruption of sedation for early rehabilitation improves outcomes in ventilated, critically ill adults.
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Needham DM, Chandolu S, and Zanni J
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- 2009
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54. Intensive care unit physician staffing: financial modeling of the Leapfrog standard.
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Pronovost PJ, Needham DM, Waters H, Birkmeyer CM, Calinawan JR, Birkmeyer JD, and Dorman T
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Objective: To evaluate from a hospital's perspective the costs and savings, over a 1-yr period, of implementing The Leapfrog Group's Intensive Care Unit Physician Staffing (IPS) standard compared with the existing standard of nonintensivist staffing in adult intensive care units.Design: Using published data, we developed a financial model of costs and savings for 6-, 12- and 18-bed intensive care units using conservative estimates for all variables. Sensitivity analyses, including a best-case and worst-case scenario, were performed to evaluate the impact of changing assumptions on the outcome of the model.Setting: Nonrural hospitals in the United States.Patients: All adult intensive care unit patients.Interventions: The IPS standard requires that intensive care units have a dedicated intensivist present during daytime hours. Outside of these hours, an intensivist must be immediately available by pager, and a physician or 'physician extender' must be in the hospital and able to immediately reach intensive care unit patients.Measurements and Main Results: Cost savings ranged from $510,000 to $3.3 million for 6- to 18-bed intensive care units. The best-case scenario demonstrated savings of $4.2-13 million. Under the worst-case scenario, there was a net cost of $890,000 to $1.3 million.Conclusions: Financial modeling of implementation of the IPS standard using conservative assumptions demonstrated cost savings to hospitals. Only under worst-case scenario assumptions did intensivist staffing result in additional cost to hospitals. These economic findings must be interpreted in the context of significant reductions in patient morbidity and mortality rates also associated with intensivist staffing. Given the magnitude of its clinical and financial impact, hospital leaders should be asking 'how to' rather than 'whether to' implement The Leapfrog Group's ICU Physician Staffing standard. [ABSTRACT FROM AUTHOR]
- Published
- 2006
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55. Catheter-related bloodstream infections.
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Jenny-Avital ER, Daley MR, Pronovost PJ, Needham DM, Berenholtz S, and Daley, Mark R
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- 2007
56. Non-photosynthetic lineages sibling to Cyanobacteria associate with eukaryotes in the open ocean.
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Wittmers F, Comstock J, Poirier C, Needham DM, Schulz F, Malmstrom R, Carlson CA, and Worden AZ
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- Oceans and Seas, Cyanobacteria genetics, Cyanobacteria classification, Bacteria genetics, Bacteria classification, Seawater microbiology, Metagenome, Phylogeny, Eukaryota genetics, Eukaryota classification
- Abstract
Margulisbacteria are elusive uncultivated bacteria that have illuminated evolutionary transitions in the progenitor of Cyanobacteria, the latter being a critically important phylum that underpins oxygenic photosynthesis
1 , 2 . The non-photosynthetic Margulisbacteria were discovered in a sulfidic spring3 and later in other habitats4 5 6 . Currently, this candidate phylum partitions into the Riflemargulisbacteria, primarily from sediments and groundwater, the Termititenax from insect gut microbiomes, and the Marinamargulisbacteria, from marine samples4 5 6 . We found that Marinamargulisbacteria amplicons were unusually distributed in size-fractionated samples from the sunlit photic and dark twilight zones of the ocean. Further, sequencing of wild marine protists rendered genomic information for distinct marinamargulisbacterial clades co-associated with uncultivated, non-photosynthetic Stramenopila and Opisthokonta protists. Phylogenomic analyses combining these data and available metagenome-assembled genomes (MAGs) and single-amplified genomes (SAGs) from sorted bacteria revealed new Marinamargulisbacteria lineages. The lineages delineate by their environment, forming clades comprising freshwater, marine pelagic, or sediment/hypoxic taxa. The remarkable diversity of Margulisbacteria indicates success in colonizing various habitats, potentially in a conserved strategy involving eukaryotic cells., Competing Interests: Declaration of interests The authors declare no competing interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)- Published
- 2024
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57. The COVID-19 Pandemic and Patient Expectations About Recovery From Acute Respiratory Failure.
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Bouhassira DC, Dinglas VD, Lee EM, Beesley S, Carmichael H, Jackson JC, Mir-Kasimov M, Sevin CM, Bose S, Goodspeed V, Hopkins RO, Brown SM, Needham DM, and Turnbull AE
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- 2024
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58. Participant retention in follow-up studies of intensive care unit survivors - A scoping review.
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Young DL, Al-Ani A, Lakhmalla M, Raman V, Fatima A, Friedman LA, Challa SR, Vasishta S, Koneru M, Colantuoni E, Needham DM, and Dinglas VD
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- Humans, Follow-Up Studies, Critical Illness, Intensive Care Units, Survivors
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Objective: To synthesize participant retention data and related reporting in studies evaluating post-hospital outcomes of survivors of critical illness after an intensive care unit (ICU) stay., Review Method Used: A synthesis of literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist., Data Sources: PubMed, EMBASE, PsycINFO, Cumulative Index of Nursing and Allied Health Literature, and the Cochrane Controlled Trials Registry. Hand searched reference lists and personal files of relevant narrative and systematic review articles., Review Methods: Articles were screened by pairs of independent reviewers. Similarly, data were abstracted by pairs of data collectors, with conflicts resolved by consensus or by a third reviewer., Results: We included 243 publications, from 225 unique studies of 87,602 participants. Participant retention could not be calculated for any time-points in 13% of studies nor in 22% of all follow-up time-points. Retention ranged from 18-100%. When compared to follow-up before 1-month, retention at each later timepoint was not significantly different. Age and sex were not associated with retention and more recent studies had decreased retention (odds ratio: 0.94 [95% confidence interval: 0.92-0.96; p < 0.001]). Reporting of retention-related study methodology was inconsistent., Conclusion: Retention rate could not be calculated for 22% of study follow-up time-points, with retention at the remaining time-points generally being high (≥85%), but with high variability (18% - 100%). ICU survivorship research could be improved via: (i) more detailed guidance on reporting participant retention, and (ii) use of existing resources and best practices to facilitate better study design and to improve participant retention to preserve statistical power and reduce selection bias., Competing Interests: Conflict of interest The authors do not have any conflict of interests to declare., (Copyright © 2024 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.)
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- 2024
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59. Prescription of potentially inappropriate medications after an intensive care unit stay for acute respiratory failure.
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Bose S, Groat D, Stollings JL, Barney P, Dinglas VD, Goodspeed VM, Carmichael H, Mir-Kasimov M, Jackson JC, Needham DM, Brown SM, and Sevin CM
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- Humans, Female, Male, Prospective Studies, Aged, Middle Aged, Respiratory Insufficiency, Patient Readmission statistics & numerical data, Patient Discharge, Intensive Care Units, Inappropriate Prescribing, Potentially Inappropriate Medication List
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Background: Among survivors of critical illness, prescription of potentially inappropriate medications (PIM) at hospital discharge is thought to be an important, modifiable patient safety concern. To date, there are little empirical data evaluating this issue., Research Question: The objective of this study was to determine the frequency of PIM prescribed to survivors of acute respiratory failure (ARF) at hospital discharge and explore their association with readmissions or death within 90 days of hospital discharge., Study Design and Methods: Prospective multicenter cohort study of ARF survivors admitted to ICUs and discharged home. Prospective of new PIMs with a high-adverse-effect profile ("high impact") at discharge was the primary exposure. Potential inappropriateness was determined by a structured consensus process using Screening Tool of Older Persons' Prescriptions-Screening Tool to Alert to Right Treatment, Beers' criteria, and clinical context of prescriptions by a multidisciplinary team. Covariate balancing propensity score was used for the primary analysis., Results: Of the 195 Addressing Post Intensive Care Syndrome-01 (APICS-01) patients, 169 (87%) had ≥1 new medications prescribed at discharge, with 154 (91.1%) prescribed with one or more high-impact (HI) medications. Patients were prescribed a median of 5 [3-7] medications, of which 3 [1-4] were HI. Twenty percent of HI medications were potentially inappropriate. Medications with significant central nervous system side-effects were most prescribed potentially inappropriately. Forty-six (30%) patients experienced readmission or death within 90 days of hospital discharge. After adjusting for prespecified covariates, the association between prescription of potentially inappropriate HI medications and the composite primary outcome did not meet the prespecified threshold for statistical significance (risk ratio: 0.54; 0.26-1.13; p = 0.095) or with the constituent endpoints: readmission (risk ratio: 0.57, 0.27-1.11) or death (0.7, 0.05-9.32)., Conclusion: At hospital discharge, most ARF survivors are prescribed medications with a high-adverse-effect profile and approximately one-fifth are potentially inappropriate. Although prescription of such medications was not associated with 90-day readmissions and mortality, these results highlight an area for additional investigation., (Copyright © 2024 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2024
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60. Delirium Screening in Critically Ill Children: Secondary Analysis of the Multicenter PICU Up! Pilot Trial Dataset, 2019-2020.
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Azamfirei R, Behrens D, Padilla S, Madden K, Goldberg S, Geno M, Manning MJ, Piole M, Madsen E, Maue D, Abu-Sultaneh S, Awojoodu R, Wang NY, Needham DM, Neufeld K, and Kudchadkar SR
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- Humans, Male, Female, Pilot Projects, Child, Preschool, Child, Infant, Prospective Studies, Adolescent, Prevalence, Length of Stay statistics & numerical data, Respiration, Artificial statistics & numerical data, Risk Factors, United States epidemiology, Delirium diagnosis, Delirium epidemiology, Intensive Care Units, Pediatric, Critical Illness, Mass Screening methods
- Abstract
Objectives: To determine the patient-level factors associated with performing daily delirium screening in PICUs with established delirium screening practices., Design: A secondary analysis of 2019-2020 prospective data from the baseline phase of the PICU Up! pilot stepped-wedge multicenter trial (NCT03860168)., Setting: Six PICUs in the United States., Patients: One thousand sixty-four patients who were admitted to a PICU for 3 or more days., Interventions: None., Measurements and Main Results: Of 1064 patients, 74% (95% CI, 71-76%) underwent delirium screening at least once during their PICU stay. On 57% of the 8965 eligible patient days, screening was conducted. The overall prevalence of delirium was 46% across all screened days, and 64% of screened patients experienced delirium at some point during their PICU stay. Factors associated with greater adjusted odds ratio (aOR) of increased daily delirium screening included PICU stay longer than 15 days compared with 1-3 days (aOR 3.36 [95% CI, 2.62-4.30]), invasive mechanical ventilation as opposed to room air (aOR 1.67 [95% CI, 1.32-2.12]), dexmedetomidine infusions (aOR 1.23 [95% CI, 1.04-1.44]) and propofol infusions (aOR 1.55 [95% CI, 1.08-2.23]). Conversely, decreased aOR of daily delirium screening was associated with female gender (aOR 0.78 [95% CI, 0.63-0.96]), and the administration of continuous infusions of opioids (aOR 0.75 [95% CI, 0.63-0.90]) or ketamine (aOR 0.48 [95% CI, 0.29-0.79]). Neither patient age, the presence of family or physical restraints, or benzodiazepine infusions were associated with daily delirium screening rates., Conclusions: In the 2019-2020 PICU UP! cohort, across six PICUs, delirium screening occurred on only 57% of days, despite the presence of established practices. Female gender, patients in the early stages of their PICU stay, and patients not receiving mechanical ventilation were associated with lower odds of daily delirium screening. Our results highlight the need for structured quality improvement processes to both standardize and increase the frequency of delirium screening., Competing Interests: Dr. Azamfirei was supported by the William Walker Award from the Johns Hopkins Department of Psychiatry and Drs. Kudchadkar and Needham were supported by the Donaghue Foundation Greater Value Portfolio Award. Dr. Wang was supported by grant UL1 TR003098 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCATS or NIH. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)
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- 2024
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61. Extended versus Standard Proning Duration for COVID-19-associated Acute Respiratory Distress Syndrome: A Target Trial Emulation Study.
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Hochberg CH, Colantuoni E, Sahetya SK, Eakin MN, Fan E, Psoter KJ, Iwashyna TJ, Needham DM, and Hager DN
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- Humans, Male, Female, Middle Aged, Aged, Prone Position, Patient Positioning methods, Intensive Care Units, Time Factors, Retrospective Studies, COVID-19 complications, COVID-19 therapy, COVID-19 mortality, Respiratory Distress Syndrome therapy, Respiratory Distress Syndrome mortality, Respiration, Artificial methods, Respiration, Artificial statistics & numerical data, SARS-CoV-2
- Abstract
Rationale: Prone positioning for ⩾16 hours in moderate-to-severe acute respiratory distress syndrome (ARDS) improves survival. However, the optimal duration of proning is unknown. Objectives: To estimate the effect of extended versus standard proning duration on patients with moderate-to-severe coronavirus disease (COVID-19) ARDS. Methods: Data were extracted from a five-hospital electronic medical record registry. Patients who were proned within 72 hours of mechanical ventilation were categorized as receiving extended (⩾24 h) versus standard (16-24 h) proning based on the first proning session length. We used a target trial emulation design to estimate the effect of extended versus standard proning on the primary outcome of 90-day mortality and secondary outcomes of ventilator liberation and intensive care unit (ICU) discharge. Analytically, we used inverse probability of treatment weighted (IPTW) Cox or Fine-Gray regression models. Results: A total of 314 patients were included; 234 received extended proning, and 80 received standard-duration proning. Patients who received extended proning were older, had greater comorbidity, were more often at an academic hospital, and had shorter time from admission to mechanical ventilation. After IPTW, characteristics were well balanced. Unadjusted 90-day mortality in the extended versus standard proning groups was 39% versus 58%. In doubly robust IPTW analyses, we found no significant effects of extended versus standard proning duration on mortality (hazard ratio [95% confidence interval], 0.95 [0.51-1.77]), ventilator liberation (subdistribution hazard, 1.60 [0.97-2.64], or ICU discharge (subdistribution hazard, 1.31 [0.82-2.10]). Conclusions: Using target trial emulation, we found no significant effect of extended versus standard proning duration on mortality, ventilator liberation, or ICU discharge. However, given the imprecision of estimates, further study is justified.
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- 2024
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62. Survivorship After Neurocritical Care: A Scoping Review of Outcomes Beyond Physical Status.
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LaBuzetta JN, Bongbong DN, Mlodzinski E, Sheth R, Trando A, Ibrahim N, Yip B, Malhotra A, Dinglas VD, Needham DM, and Kamdar BB
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- Humans, Survivors, Nervous System Diseases etiology, Employment statistics & numerical data, Outcome Assessment, Health Care, Mental Health, Critical Care, Quality of Life, Survivorship, Critical Illness
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Following intensive care unit hospitalization, survivors of acute neurological injury often experience debilitating short-term and long-term impairments. Although the physical/motor impairments experienced by survivors of acute neurological injury have been described extensively, fewer studies have examined cognitive, mental health, health-related quality of life (HRQoL), and employment outcomes. This scoping review describes the publication landscape beyond physical and/or motor sequelae in neurocritical care survivors. Databases were searched for terms related to critical illness, intensive care, and outcomes from January 1970 to March 2022. English-language studies of critically ill adults with a primary neurological diagnosis were included if they reported on at least one outcome of interest: cognition, mental health, HRQoL or employment. Data extraction was performed in duplicate for prespecified variables related to study outcomes. Of 16,036 abstracts screened, 74 citations were identified for inclusion. The studies encompassed seven worldwide regions and eight neurocritical diagnosis categories. Publications reporting outcomes of interest increased from 3 before the year 2000 to 71 after. Follow-up time points included ≤ 1 (n = 15 [20%] citations), 3 (n = 28 [38%]), 6 (n = 28 [38%]), and 12 (n = 21 [28%]) months and 1 to 5 (n = 19 [26%]) and > 5 years (n = 8 [11%]), with 28 (38%) citations evaluating outcomes at multiple time points. Sixty-six assessment tools were used to evaluate the four outcomes of interest: 22 evaluating HRQoL (56 [76%] citations), 21 evaluating cognition (20 [27%] citations), 21 evaluating mental health (18 [24%] citations), and 2 evaluating employment (9 [12%] citations). This scoping review aimed to better understand the literature landscape regarding nonphysical outcomes in survivors of neurocritical care. Although a rising number of publications highlight growing awareness, future efforts are needed to improve study consistency and comparability and characterize outcomes in a disease-specific manner, including outlining of a minimum core outcomes set and associated assessment tools., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society.)
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- 2024
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63. Updates on Post-Intensive Care Syndrome After Acute Respiratory Distress Syndrome: Epidemiology, Core Outcomes, Interventions, and Long-Term Follow-Up.
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Hiser SL, Fatima A, Dinglas VD, and Needham DM
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- Humans, Survivors, Critical Care, Critical Illness, Respiratory Distress Syndrome therapy, Respiratory Distress Syndrome epidemiology, Quality of Life
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Acute respiratory distress syndrome (ARDS) survivors often experience post-intensive care syndrome (PICS), is defined as new or worsened impairments in physical, cognitive and/or mental health status persisting beyond hospital discharge. These impairments negatively impact survivors' quality of life and their return to work or usual activities. Moreover, family members are also impacted as recognized by the term, PICS-Family (PICS-F). PICS poses an increased burden on the health care system and has a negative societal impact. There are ongoing efforts to understand risk factors for PICS-related impairments; design and evaluate interventions for specific impairments (including the use of an ARDS survivorship core outcome set); and refine and evaluate ICU recovery clinics to support and treat survivors and their families., Competing Interests: Disclosure None of the authors have any conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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64. PRACTICE: Development of a Core Outcome Set for Trials of Physical Rehabilitation in Critical Illness.
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Connolly BA, Barclay M, Davies C, Hart N, Pattison N, Sturmey G, Williamson PR, Needham DM, Denehy L, and Blackwood B
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Rationale Findings from individual trials of physical rehabilitation interventions in critically ill adults have limited potential for meta-analysis and informing clinical decision-making due to heterogeneity in selection and reporting of outcomes used for evaluation. Objective The objective of this study was to determine a core outcome set (COS) for use in all future trials evaluating physical rehabilitation interventions delivered across the critical illness continuum of recovery. Methods An international, two-round, online, modified Delphi consensus process, following recommended standards, was conducted. Participants (N=329) comprised three stakeholder groups (Researchers, n=58 (18%); Clinicians, n=247 (75%); Patients and Caregivers, n=24 (7%)), and represented 26 countries and 9 healthcare professions. Participants rated the importance of a range of relevant outcomes. Outcomes included in the COS were those prioritised of "critical importance" by all three stakeholder groups. Results Survey response rates were 88% (Round 1) and 91% (Round 2). From a total of 32 initial outcomes, the following outcomes reached consensus for inclusion in the COS: Physical Function, Activities of Daily Living, Survival, Health-related Quality of Life, Exercise Capacity, Cognitive Function, Emotional and Mental Wellbeing, and Frailty. Conclusion This study developed a consensus-generated COS for future clinical research evaluating physical rehabilitation interventions in critically ill adults across the continuum of recovery. Ascertaining recommended measurement instruments for these core outcomes is now required to facilitate implementation of the COS. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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- 2024
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65. Comparative analysis of financial toxicity between SARS-CoV-2 infection and common comorbidities.
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Su H, Thompson HJ, Figuracion KC, Patel MB, and Needham DM
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- Humans, Male, Female, Middle Aged, Adult, United States epidemiology, Cross-Sectional Studies, Aged, Cost of Illness, Young Adult, Health Care Costs, Post-Acute COVID-19 Syndrome, Adolescent, COVID-19 economics, COVID-19 epidemiology, Comorbidity, SARS-CoV-2
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Financial toxicity is common in individuals with COVID-19 and Long COVID. However, the extent of financial toxicity experienced, in comparison to other common comorbidities, is uncertain. Contributing factors exacerbating financial challenges in Long COVID are also unclear. These knowledge gaps are addressed via a cross-sectional analysis utilizing data from the 2022 National Health Interview Survey (NHIS), a representative sample drawn from the United States. COVID-19 cases were identified through self-reported positive testing or physician diagnoses. Long COVID was defined as experiencing COVID-19-related symptoms for more than three months. Comorbidity was assessed based on self-reported diagnoses of ten doctor-diagnosed conditions (Yes/No). Financial toxicity was defined as having difficulty paying medical bills, cost-related medication nonadherence, delaying healthcare due to cost, and/or not obtained healthcare due to cost. A total of 27,492 NHIS 2022 respondents were included in our analysis, representing 253 million U.S. adults. In multivariable logistic regression models, adults with Long COVID (excluding respondents with COVID-19 but not Long COVID), showed increased financial toxicity compared to those with other comorbidities, such as epilepsy (OR [95% CI]: 1.69 [1.22, 2.33]), dementia (1.51 [1.01, 2.25]), cancer (1.43 [1.19, 1.71]) or respiratory/cardiovascular conditions (1.18 [1.00, 1.40]/1.23 [1.02, 1.47]). Long COVID-related financial toxicity was associated with female sex, age <65 years, lack of medical insurance, current paid employment, residence region, food insecurity, fatigue, mild to severe depression symptoms experienced during the survey completion, visits to hospital emergency rooms, presence of arthritis, cardiovascular or respiratory conditions, and social activity limitations. In conclusion, American adults with Long COVID, but not those who had prior COVID-19 infection without Long COVID, exhibited a higher prevalence of financial toxicity compared to individuals with common comorbidities. Vulnerable populations were at greater risk for financial toxicity. These findings emphasize the importance of evaluating strategies to reduce economic burden and increase awareness of the effect of Long COVID-related financial toxicity on patient's healthcare and health status., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Su et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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66. Reliability and validity of the Chinese version of the functional status score for the ICU (FSS-ICU) after translation and cross-cultural adaptation.
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Wu TT, Su QP, Xiong J, Hiser S, Needham DM, and Li H
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Purpose: The Functional Status Score for the Intensive Care Unit (FSS-ICU) is designed to assess the physical functional status of patients in ICU settings. This study aimed to translate and culturally adapt the FSS-ICU for the Chinese context and to evaluate its reliability and validity., Methods: Following Beaton's translation model, the original FSS-ICU was subjected to forward translation, back-translation, and synthesis. After cultural adaptation and preliminary testing, the Chinese version of the FSS-ICU was established, and then two rehabilitation therapists assessed the functional status of 51 ICU patients using this scale, evaluating its reliability and validity., Results: The Chinese version of the FSS-ICU exhibits excellent internal consistency with a Cronbach's alpha coefficient of 0.934. The inter-rater and intra-rater correlation coefficients are 0.995 and 0.997, respectively. Both item-level and scale-level content validity indices are 1.00. The FSS-ICU demonstrates good convergent validity with other physical function assessment tools (Medical Research Council Sum-Score, grip strength, the Intensive Care Unit Mobility Scale), with |r
s | values all above 0.5, and satisfactory discriminant validity with non-physical function assessment indicators (body mass index, blood glucose), with |rs | values all below 0.2. Additionally, it demonstrated no ceiling or floor effects., Conclusion: The Chinese FSS-ICU, demonstrating strong reliability and validity, can serve as an effective assessment tool for physical function in ICU patients.- Published
- 2024
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67. Mental health sequelae in survivors of cardiogenic shock complicating myocardial infarction. A population-based cohort study.
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Fernando SM, Qureshi D, Talarico R, Vigod SN, McIsaac DI, Sterling LH, van Diepen S, Price S, Di Santo P, Kyeremanteng K, Fan E, Needham DM, Brodie D, Bienvenu OJ, Combes A, Slutsky AS, Scales DC, Herridge MS, Thiele H, Hibbert B, Tanuseputro P, and Mathew R
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- Humans, Male, Female, Aged, Retrospective Studies, Middle Aged, Ontario epidemiology, Mental Disorders epidemiology, Mental Disorders etiology, Mental Disorders complications, Cohort Studies, Aged, 80 and over, Incidence, Mental Health, Myocardial Infarction complications, Myocardial Infarction psychology, Myocardial Infarction epidemiology, Shock, Cardiogenic psychology, Shock, Cardiogenic etiology, Shock, Cardiogenic epidemiology, Survivors psychology, Survivors statistics & numerical data
- Abstract
Purpose: Cardiogenic shock secondary to acute myocardial infarction (AMI-CS) is associated with substantial short- and long-term morbidity and mortality. However, there are limited data on mental health sequelae that survivors experience following discharge., Methods: We conducted a retrospective, population-based cohort study in Ontario, Canada of critically ill adult (≥ 18 years) survivors of AMI-CS, admitted to hospital between April 1, 2009 and March 31, 2019. We compared these patients to AMI survivors without shock. We captured outcome data using linked health administrative databases. The primary outcome was a new mental health diagnosis (a composite of mood, anxiety, or related disorders; schizophrenia/psychotic disorders; and other mental health disorders) following hospital discharge. We secondarily evaluated incidence of deliberate self-harm and death by suicide. We compared patients using overlap propensity score-weighted, cause-specific proportional hazard models., Results: We included 7812 consecutive survivors of AMI-CS, from 135 centers. Mean age was 68.4 (standard deviation (SD) 12.2) years, and 70.3% were male. Median follow-up time was 767 days (interquartile range (IQR) 225-1682). Incidence of new mental health diagnosis among AMI-CS survivors was 109.6 per 1,000 person-years (95% confidence interval (CI) 105.4-113.9), compared with 103.8 per 1000 person-years (95% CI 102.5-105.2) among AMI survivors without shock. After propensity score adjustment, there was no difference in the risk of new mental health diagnoses following discharge [hazard ratio (HR) 0.99 (95% CI 0.94-1.03)]. Factors associated with new mental health diagnoses following AMI-CS included female sex, pre-existing mental health diagnoses, and discharge to a long-term hospital or rehabilitation institute., Conclusion: Survivors of AMI-CS experience substantial mental health morbidity following discharge. Risk of new mental health diagnoses was comparable between survivors of AMI with and without shock. Future research on interventions to mitigate psychiatric sequelae after AMI-CS is warranted., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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68. Tackling Brain and Muscle Dysfunction in Acute Respiratory Distress Syndrome Survivors: NHLBI Workshop Report.
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Palakshappa JA, Batt JAE, Bodine SC, Connolly BA, Doles J, Falvey JR, Ferrante LE, Files DC, Harhay MO, Harrell K, Hippensteel JA, Iwashyna TJ, Jackson JC, Lane-Fall MB, Monje M, Moss M, Needham DM, Semler MW, Lahiri S, Larsson L, Sevin CM, Sharshar T, Singer B, Stevens T, Taylor SP, Gomez CR, Zhou G, Girard TD, and Hough CL
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- Humans, United States, National Heart, Lung, and Blood Institute (U.S.), Quality of Life, Brain physiopathology, Respiratory Distress Syndrome therapy, Respiratory Distress Syndrome physiopathology, Survivors
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Acute respiratory distress syndrome (ARDS) is associated with long-term impairments in brain and muscle function that significantly impact the quality of life of those who survive the acute illness. The mechanisms underlying these impairments are not yet well understood, and evidence-based interventions to minimize the burden on patients remain unproved. The NHLBI of the NIH assembled a workshop in April 2023 to review the state of the science regarding ARDS-associated brain and muscle dysfunction, to identify gaps in current knowledge, and to determine priorities for future investigation. The workshop included presentations by scientific leaders across the translational science spectrum and was open to the public as well as the scientific community. This report describes the themes discussed at the workshop as well as recommendations to advance the field toward the goal of improving the health and well-being of ARDS survivors.
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- 2024
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69. Gradients of bacteria in the oceanic water column reveal finely-resolved vertical distributions.
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Harbeitner RC, Wittmers F, Yung CCM, Eckmann CA, Hehenberger E, Blum M, Needham DM, and Worden AZ
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- Water, RNA, Ribosomal, 16S genetics, Phylogeny, Bacteria genetics, Oceans and Seas, Seawater microbiology, Alphaproteobacteria genetics, Gammaproteobacteria genetics
- Abstract
Bacterial communities directly influence ecological processes in the ocean, and depth has a major influence due to the changeover in primary energy sources between the sunlit photic zone and dark ocean. Here, we examine the abundance and diversity of bacteria in Monterey Bay depth profiles collected from the surface to just above the sediments (e.g., 2000 m). Bacterial abundance in these Pacific Ocean samples decreased by >1 order of magnitude, from 1.22 ±0.69 ×106 cells ml-1 in the variable photic zone to 1.44 ± 0.25 ×105 and 6.71 ± 1.23 ×104 cells ml-1 in the mesopelagic and bathypelagic, respectively. V1-V2 16S rRNA gene profiling showed diversity increased sharply between the photic and mesopelagic zones. Weighted Gene Correlation Network Analysis clustered co-occurring bacterial amplicon sequence variants (ASVs) into seven subnetwork modules, of which five strongly correlated with depth-related factors. Within surface-associated modules there was a clear distinction between a 'copiotrophic' module, correlating with chlorophyll and dominated by e.g., Flavobacteriales and Rhodobacteraceae, and an 'oligotrophic' module dominated by diverse Oceanospirillales (such as uncultured JL-ETNP-Y6, SAR86) and Pelagibacterales. Phylogenetic reconstructions of Pelagibacterales and SAR324 using full-length 16S rRNA gene data revealed several additional subclades, expanding known microdiversity within these abundant lineages, including new Pelagibacterales subclades Ia.B, Id, and IIc, which comprised 4-10% of amplicons depending on the subclade and depth zone. SAR324 and Oceanospirillales dominated in the mesopelagic, with SAR324 clade II exhibiting its highest relative abundances (17±4%) in the lower mesopelagic (300-750 m). The two newly-identified SAR324 clades showed highest relative abundances in the photic zone (clade III), while clade IV was extremely low in relative abundance, but present across dark ocean depths. Hierarchical clustering placed microbial communities from 900 m samples with those from the bathypelagic, where Marinimicrobia was distinctively relatively abundant. The patterns resolved herein, through high resolution and statistical replication, establish baselines for marine bacterial abundance and taxonomic distributions across the Monterey Bay water column, against which future change can be assessed., Competing Interests: The author have declared that no competing interests exist., (Copyright: © 2024 Harbeitner et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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70. Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children".
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Seylanova N, Chernyavskaya A, Degtyareva N, Mursalova A, Ajam A, Xiao L, Aktulaeva K, Roshchin P, Bobkova P, Aiyegbusi OL, Anbu AT, Apfelbacher C, Asadi-Pooya AA, Ashkenazi-Hoffnung L, Brackel C, Buonsenso D, de Groote W, Diaz JV, Dona D, Dunn Galvin A, Genuneit J, Goss H, Hughes SE, Jones CJ, Kuppalli K, Malone LA, McFarland S, Needham DM, Nekliudov N, Nicholson TR, Oliveira CR, Schiess N, Segal TY, Sigfrid L, Thorne C, Vijverberg S, Warner JO, Were WM, Williamson PR, and Munblit D
- Subjects
- Adolescent, Child, Humans, Delphi Technique, Outcome Assessment, Health Care, Research Design, Treatment Outcome, COVID-19, Post-Acute COVID-19 Syndrome
- Abstract
The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide., Competing Interests: Conflict of interest: D. Munblit is a Co-Chair of International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) Global Paediatric Long COVID Working Group, member of ISARIC working group on long-term follow-up in adults. C. Apfelbacher reports grants or contracts from Dr Wolff Group, Bionorica and The European Cooperation in Science and Technology (COST); he also acknowledges consulting fees from the Dr Wolff Group, Bionorica, Sanofi and LEO Pharma; he serves as a Co-Chair Harmonising Outcome Measures for Eczema (HOME) initiative and is Co-Chair of the Hand Eczema Core Outcome Set (HECOS) initiative and is core principal investigator of the KUNOKids Health Study (Regensburg, Germany). J.V. Diaz is the lead of the clinical management response pillar for COVID-19 and in that capacity convenes the WHO Clinical Characterization and Management Research working group; the Post COVID-19 COS steering committee was a sub-working group of this bigger group. O.L. Aiyegbusi has received research grants from UCB, Kidney Research UK, Gilead Sciences Ltd, The Health Foundation, NIHR Birmingham BRC, NIHR ARC, NIHR BTRU, Innovate UK, Merck, GSK, Anthony Nolan and Sarcoma UK; he has also received personal fees from GSK, Gilead Sciences, Innovate UK and Merck. C.R. Oliveira receives grant support from the National Institutes of Health (NIH), grant numbers OT2HL161847 and K23AI159518. P.R. Williamson is chair of the Core Outcome Measures in Effectiveness Trials (COMET) Management Group. Other authors declare that they have no competing interests., (Copyright ©The authors 2024.)
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- 2024
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71. Improving management of ARDS: uniting acute management and long-term recovery.
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Latronico N, Eikermann M, Ely EW, and Needham DM
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- Humans, Quality of Life, Activities of Daily Living, Hypnotics and Sedatives therapeutic use, Muscle Weakness etiology, Adrenal Cortex Hormones therapeutic use, Intensive Care Units, Delirium complications, Respiratory Distress Syndrome
- Abstract
Acute Respiratory Distress Syndrome (ARDS) is an important global health issue with high in-hospital mortality. Importantly, the impact of ARDS extends beyond the acute phase, with increased mortality and disability for months to years after hospitalization. These findings underscore the importance of extended follow-up to assess and address the Post-Intensive Care Syndrome (PICS), characterized by persistent impairments in physical, cognitive, and/or mental health status that impair quality of life over the long-term. Persistent muscle weakness is a common physical problem for ARDS survivors, affecting mobility and activities of daily living. Critical illness and related interventions, including prolonged bed rest and overuse of sedatives and neuromuscular blocking agents during mechanical ventilation, are important risk factors for ICU-acquired weakness. Deep sedation also increases the risk of delirium in the ICU, and long-term cognitive impairment. Corticosteroids also may be used during management of ARDS, particularly in the setting of COVID-19. Corticosteroids can be associated with myopathy and muscle weakness, as well as prolonged delirium that increases the risk of long-term cognitive impairment. The optimal duration and dosage of corticosteroids remain uncertain, and there's limited long-term data on their effects on muscle weakness and cognition in ARDS survivors. In addition to physical and cognitive issues, mental health challenges, such as depression, anxiety, and post-traumatic stress disorder, are common in ARDS survivors. Strategies to address these complications emphasize the need for consistent implementation of the evidence-based ABCDEF bundle, which includes daily management of analgesia in concert with early cessation of sedatives, avoidance of benzodiazepines, daily delirium monitoring and management, early mobilization, and incorporation of family at the bedside. In conclusion, ARDS is a complex global health challenge with consequences extending beyond the acute phase. Understanding the links between critical care management and long-term consequences is vital for developing effective therapeutic strategies and improving the quality of life for ARDS survivors., (© 2024. The Author(s).)
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- 2024
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72. Physical rehabilitation while awake, intubated and proned for COVID-19-associated severe acute respiratory distress syndrome.
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Seth B, Oakman B, and Needham DM
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- Humans, SARS-CoV-2, Wakefulness, Prone Position, Respiration, Artificial, COVID-19, Respiratory Distress Syndrome etiology, Respiratory Distress Syndrome therapy
- Abstract
This case study demonstrates the implementation of evidence-based guidelines in the intensive care unit setting, including light sedation and early physical rehabilitation while receiving prone positioning and lung protective mechanical ventilation for severe acute respiratory distress syndrome from SARS-CoV-2 infection., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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73. Spanish Translation and Cultural Adaptation of the Intensive Care Unit Delirium Playbook.
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Fuentes AL, Makhija H, Fine JM, Alicea Reyes P, Diaz De Leon B, Sanchez-Azofra A, Rodriguez-Flores L, Weston J, Marquine MJ, Hu E, Espinosa-Meza R, Serafin Higuera IR, Vacas Jacques P, Pollack D, Novelli F, Ely EW, Malhotra A, Needham DM, Martin JL, Kamdar BB, Arroyo-Novoa CM, and Figueroa-Ramos MI
- Abstract
Background: A lack of high-quality provider education hinders the delivery of standard-of-care delirium detection and prevention practices in the intensive care unit (ICU). To fill this gap, we developed and validated an e-learning ICU Delirium Playbook consisting of eight videos and a 44-question knowledge assessment quiz. Given the increasing Spanish-speaking population worldwide, we translated and cross-culturally adapted the playbook from English into Spanish., Objective: To translate and culturally adapt the ICU Delirium Playbook into Spanish, the second most common native language worldwide., Methods: The translation and cross-cultural adaptation process included double forward and back translations and harmonization by a 14-person interdisciplinary team of ICU nurses and physicians, delirium experts, methodologists, medical interpreters, and bilingual professionals representing many Spanish-speaking global regions. After a preeducation quiz, a nurse focus group completed the playbook videos and posteducation quiz, followed by a semistructured interview., Results: The ICU Delirium Playbook: Spanish Version maintained conceptual equivalence to the English version. Focus group participants posted mean (standard deviation) pre- and post-playbook scores of 63% (10%) and 78% (12%), with a 15% (11%) pre-post improvement ( P = 0.01). Participants reported improved perceived competency in performing the Confusion Assessment Method for the ICU and provided positive feedback regarding the playbook., Conclusion: After translation and cultural adaptation, the ICU Delirium Playbook: Spanish Version yielded significant knowledge assessment improvements and positive feedback. The Spanish playbook is now available for public dissemination., (Copyright © 2024 by the American Thoracic Society.)
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- 2024
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74. Phase I pilot safety and feasibility of a novel restraint device for critically ill patients requiring mechanical ventilation.
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Kamdar BB, Fine JM, Pavini MT, Ardren SS, Burns S, Bates JH, McGinnis RS, Pandian V, Lin BH, Needham DM, and Stapleton RD
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Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Exersides ® Refraint ® (Healthy Design, LLC), a novel restraint alternative, may be safe and facilitate greater mobility than traditional restraints., Objective: This National Institutes of Health Small Business Technology Transfer (STTR) Program Grant-funded single-site Phase I feasibility study evaluated Exersides ® safety and feasibility in anticipation of a multi-site Phase II randomized controlled trial (RCT)., Methods: In two academic ICUs, mechanically ventilated adults ⩾25 years old who were non-comatose, required restraints and had an expected stay of ⩾2 days were enrolled to wear Exersides ® and traditional wrist restraints for 4 h on day 1, in a randomized order, and in the reverse order on day 2. Main outcomes were Exersides ® safety (i.e., patient/clinician lacerations/injuries), feasibility (i.e., ⩾90% of required data collected), and patient/family/clinician feedback., Results: Eight patients were enrolled; one no longer required restraints at initiation, yielding seven subjects (median [interquartile range (IQR)] age 65 [55, 70] years, 86% men). All seven wore Exersides ®, averaging (SD) 2.5 (1.0) hours per session, with no safety events reported. Across restraint time periods, 92% and 100% of Richmond Agitation-Sedation Scale (RASS) and wrist actigraphy data, respectively, were collected. Feedback was positive (more movement and comfortable than traditional restraints) and constructive (bulky, intimidating to apply)., Conclusions: This pilot study provided key safety and feasibility data for a Phase II RCT evaluating Exersides ® versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MTP is the inventor of the Exersides® Refraint® and founder of Healthy Design Ltd. Co. which sells the device. JHTB has consulted with Healthy Design, Ltd. Co. MTP provided technical input regarding use of the Exersides® Refraint®. MTP and JHTB were not involved with collection, analysis, or interpretation of the data. The remaining authors have no financial or other conflicts of interest., (© The Intensive Care Society 2023.)
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- 2024
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75. Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS) in the Intensive Care Unit: Protocol of a Prospective Cohort Study.
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Pandian V, Cherukuri SPS, Koneru M, Karne V, Tajrishi FZ, Aloori S, Kota P, Dinglas V, Colantuoni E, Akst L, Hillel AT, Needham DM, and Brodsky MB
- Abstract
Aims: The Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS) study systematically evaluates patient symptoms related to endotracheal intubation with mechanical ventilation, assesses laryngeal injury and voice function after extubation, and develops a screening tool to identify patients with clinically important, post-extubation laryngeal injury., Design: Single-center, prospective observational cohort study conducted in 6 intensive care units (ICU)., Methods: Patients ≥18 years old who are orally intubated and mechanically ventilated in an ICU and meet eligibility criteria will undergo flexible laryngoscopy, with a sample size goal of 300 completed laryngoscopies. Primary outcome measures include signs and symptoms of laryngeal injury, including voice symptoms and alterations in swallowing, measured using the Laryngeal Hypersensitivity Questionnaire-Acute and Voice Symptom Scale questionnaires respectively. Data will be collected within 72 hours post-extubation and at 7-day follow-up or hospital discharge (whichever occurs first). Data will be analyzed using descriptive statistics, regression models, and predictive modeling using machine learning., Discussion: The findings of this study will describe the clinical signs and symptoms of laryngeal injury post-extubation., Conclusion: The PALSS study will provide insights for future studies that explore laryngeal injuries using flexible laryngoscopy after endotracheal intubation., Implications for Patient Care: Identifying signs and symptoms of laryngeal injury after endotracheal intubation will facilitate the development of a screening tool that will assist in early identification of post-extubation laryngeal injury, and aid in decreasing short- and long-term complications of endotracheal intubation., Reporting Method: SPIRIT., Patient or Public Contribution: Patients were study participants; and family members provided informed consent when the patient lacked decision-making capacity., Competing Interests: This study is funded by the National Institute of Nursing Research of the National Institute of Health, Bethesda, United States.Conflict of Interest Statement No conflict of interest
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- 2024
76. Instrument adaptation and preliminary validation study of the Laryngeal Hypersensitivity Questionnaire used for assessment of laryngeal symptoms in patients with artificial airways.
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Brodsky MB, Friedman LA, Colantuoni E, Pandian V, Vertigan AE, Needham DM, and Chan KS
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- Humans, Reproducibility of Results, Surveys and Questionnaires, Psychometrics, Intubation, Intratracheal
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Background: The Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ) was developed to measure abnormal laryngeal sensation and was originally validated in a patient sample from otolaryngologic and respiratory outpatient clinics. Modification is needed for patients who are mechanically ventilated via an endotracheal tube or a tracheostomy tube., Objectives: We sought to adapt and preliminarily validate a modified version of the LHQ appropriate for nurses and other clinicians to administer in acute hospital settings called the LHQ-Acute (LHQ-A)., Methods: Internal consistency and construct validity analyses using secondary data from patients at a tertiary teaching hospital who presented with symptoms of laryngeal irritability/hypersensitivity between September 2012 and October 2013 were performed., Results: A total of 131 patients, most complaining of coughing and dysphonia, with a median age of 58 (interquartile range: 48, 66) years and 29 healthy participants with a median age of 62 (interquartile range: 50, 66) years were analysed. The original LHQ was reduced from 14 questions with responses on a 7-point scale to the LHQ-A containing 13 questions with responses on a 4-point scale. Correlations between items of the LHQ and LHQ-A were similar, and internal consistency was excellent and highly comparable, with Cronbach's alpha = 0.906 and 0.902, respectively., Conclusions: The LHQ-A, which has been adapted for nurses and other clinicians to administer to a critically ill patient population, demonstrated comparable reliability and validity to the original LHQ. Validation of the LHQ-A in independent patient populations from acute settings is necessary to better understand norms and changes during recovery from acute illness., Competing Interests: Conflict of interest Martin B. Brodsky reports royalties from MedBridge Inc. for online continuing education and he is a consultant with Phagenesis, Inc. No other author reports any conflict of interest., (Copyright © 2023 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.)
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- 2024
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77. Psychological symptoms and health-related quality of life in intubated and non-intubated intensive care survivors: A multicentre, prospective observational cohort study.
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Rai S, Neeman T, Brown R, Sundararajan K, Rajamani A, Miu M, Panwar R, Nourse M, van Haren FMP, Mitchell I, and Needham DM
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Objective: To compare long-term psychological symptoms and health-related quality of life (HRQOL) in intubated versus non-intubated ICU survivors., Design: Prospective, multicentre observational cohort study., Setting: Four tertiary medical-surgical ICUs in Australia., Participants: Intubated and non-intubated adult ICU survivors., Main Outcome Measures: Primary outcomes : clinically significant psychological symptoms at 3- and 12-month follow-up using Post-Traumatic Stress Syndrome-14 for post-traumatic stress disorder; Depression, Anxiety Stress Scales-21 for depression, anxiety, and stress. Secondary outcomes : HRQOL, using EuroQol-5D-5L questionnaire., Results: Of the 133 ICU survivors, 54/116 (47 %) had at least one clinically significant psychological symptom (i.e., post-traumatic stress disorder, anxiety, depression, stress) at follow-up. Clinically significant scores for psychological symptoms were observed in 26 (39 %) versus 16 (32 %) at 3-months [odds ratio 1.4, 95 % confidence interval (0.66-3.13), p = 0.38]; 23 (37 %) versus 10 (31 %) at 12-months [odds ratio 1.3, 95 % confidence interval (0.53-3.31), p = 0.57] of intubated versus non-intubated survivors, respectively. Usual activities and mobility were the most commonly affected HRQOL dimension, with >30 % at 3 versus months and >20 % at 12-months of overall survivors reporting ≥ moderate problems. There was no difference between the groups in any of the EQ5D dimensions., Conclusions: Nearly one-in-two (47 %) of the intubated and non-intubated ICU survivors reported clinically significant psychological symptoms at 3 and 12-month follow-ups. Overall, more than 30 % at 3-months and over 20 % at 12-months of the survivors in both groups had moderate or worse problems with their usual activities and mobility. The presence of psychological symptoms and HRQOL impairments was similar between the groups., (© 2023 The Authors.)
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- 2023
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78. Core outcome measurement instruments for use in clinical and research settings for adults with post-COVID-19 condition: an international Delphi consensus study.
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Gorst SL, Seylanova N, Dodd SR, Harman NL, O'Hara M, Terwee CB, Williamson PR, Needham DM, Munblit D, and Nicholson TR
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- Humans, Adult, Delphi Technique, Research Design, Outcome Assessment, Health Care, Treatment Outcome, Post-Acute COVID-19 Syndrome, COVID-19
- Abstract
Post-COVID-19 condition (also known as long COVID) is a new, complex, and poorly understood disorder. A core outcome set (COS) for post-COVID-19 condition in adults has been developed and agreement is now required on the most appropriate measurement instruments for these core outcomes. We conducted an international consensus study involving multidisciplinary experts and people with lived experience of long COVID. The study comprised a literature review to identify measurement instruments for the core outcomes, a three-round online modified Delphi process, and an online consensus meeting to generate a core outcome measurement set (COMS). 594 individuals from 58 countries participated. The number of potential instruments for the 12 core outcomes was reduced from 319 to 19. Consensus was reached for inclusion of the modified Medical Research Council Dyspnoea Scale for respiratory outcomes. Measures for two relevant outcomes from a previously published COS for acute COVID-19 were also included: time until death, for survival, and the Recovery Scale for COVID-19, for recovery. Instruments were suggested for consideration for the remaining nine core outcomes: fatigue or exhaustion, pain, post-exertion symptoms, work or occupational and study changes, and cardiovascular, nervous system, cognitive, mental health, and physical outcomes; however, consensus was not achieved for instruments for these outcomes. The recommended COMS and instruments for consideration provide a foundation for the evaluation of post-COVID-19 condition in adults, which should help to optimise clinical care and accelerate research worldwide. Further assessment of this COMS is warranted as new data emerge on existing and novel measurement instruments., Competing Interests: Declaration of interests SLG is the project coordinator of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. NLH has received payment and honoraria for lectures and presentations from Lancaster University. PRW is chair of the COMET Management Group. DM is a co-chair of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) Global Paediatric Long COVID working group and a member of the ISARIC working group on long-term follow-up in adults. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)
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- 2023
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79. A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE).
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Davies TW, Kelly E, van Gassel RJJ, van de Poll MCG, Gunst J, Casaer MP, Christopher KB, Preiser JC, Hill A, Gundogan K, Reintam-Blaser A, Rousseau AF, Hodgson C, Needham DM, Schaller SJ, McClelland T, Pilkington JJ, Sevin CM, Wischmeyer PE, Lee ZY, Govil D, Chapple L, Denehy L, Montejo-González JC, Taylor B, Bear DE, Pearse RM, McNelly A, Prowle J, and Puthucheary ZA
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- Adult, Humans, Activities of Daily Living, Treatment Outcome, Outcome Assessment, Health Care, Hand Strength, Critical Illness therapy
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Background: CONCISE is an internationally agreed minimum set of outcomes for use in nutritional and metabolic clinical research in critically ill adults. Clinicians and researchers need to be aware of the clinimetric properties of these instruments and understand any limitations to ensure valid and reliable research. This systematic review and meta-analysis were undertaken to evaluate the clinimetric properties of the measurement instruments identified in CONCISE., Methods: Four electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted., Results: A total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high., Conclusions: Variable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness., Trial Registration: PROSPERO (CRD42023438187). Registered 21/06/2023., (© 2023. The Author(s).)
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- 2023
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80. Development and Validation of an ICU Delirium Playbook for Provider Education.
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Makhija H, Fine JM, Pollack D, Novelli F, Davidson JE, Cotton SA, Diaz De Leon B, Reyes PA, Montoya JL, Arroyo-Novoa CM, Figueroa-Ramos MI, Song Y, Fuentes AL, LaBuzetta JN, Moore AA, Ely EW, Malhotra A, Needham DM, Martin JL, and Kamdar BB
- Abstract
Although delirium detection and prevention practices are recommended in critical care guidelines, there remains a persistent lack of effective delirium education for ICU providers. To address this knowledge-practice gap, we developed an "ICU Delirium Playbook" to educate providers on delirium detection (using the Confusion Assessment Method for the ICU) and prevention., Design: Building on our previous ICU Delirium Video Series, our interdisciplinary team developed a corresponding quiz to form a digital "ICU Delirium Playbook." Playbook content validity was evaluated by delirium experts, and face validity by an ICU nurse focus group. Additionally, focus group participants completed the quiz before and after video viewing. Remaining focus group concerns were evaluated in semi-structured follow-up interviews., Setting: Online validation survey, virtual focus group, and virtual interviews., Subjects: The validation group included six delirium experts in the fields of critical care, geriatrics, nursing, and ICU education. The face validation group included nine ICU nurses, three of whom participated in the semi-structured feedback interviews., Interventions: None., Measurements and Main Results: The 44-question quiz had excellent content validity (average scale-level content validity index [S-CVI] of individual items = 0.99, universal agreement S-CVI = 0.93, agreement κ ≥ 0.75, and clarity p ≥ 0.8). The focus group participants completed the Playbook in an average (sd) time of 53 (14) minutes, demonstrating significant improvements in pre-post quiz scores (74% vs 86%; p = 0.0009). Verbal feedback highlighted the conciseness, utility, and relevance of the Playbook, with all participants agreeing to deploy the digital education module in their ICUs., Conclusions: The ICU Delirium Playbook is a novel, first-of-its-kind asynchronous digital education tool aimed to standardize delirium detection and prevention practices. After a rigorous content and face validation process, the Playbook is now available for widespread use., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.)
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- 2023
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81. Health Expectations and Quality of Life After Acute Respiratory Failure: A Multicenter Prospective Cohort Study.
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Turnbull AE, Lee EM, Dinglas VD, Beesley S, Bose S, Banner-Goodspeed V, Hopkins RO, Jackson JC, Mir-Kasimov M, Sevin CM, Brown SM, and Needham DM
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- Adult, Humans, Prospective Studies, Motivation, Longitudinal Studies, Surveys and Questionnaires, Quality of Life, Respiratory Insufficiency therapy
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Background: Patients often have high expectations for recovery after critical illness, but the impact of these expectations on subsequent quality of life (QoL) after serious illnesses has not been evaluated empirically., Research Question: Among adult survivors of acute respiratory failure (ARF), are met vs unmet expectations for health associated with self-reported QoL 6 months after discharge?, Study Design and Methods: This was a prospective longitudinal cohort study enrolling consecutive adult patients with ARF managed in ICUs at five academic medical centers. At hospital discharge, we evaluated participants' expected health 6 months in the future via a visual analog scale (VAS; range, 0-100), with higher scores representing better expected health. At 6-month follow-up, perceived health was assessed using the EQ-5D VAS, and QoL was assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) instrument. Participants' health expectations were categorized as having been met when perceived health at 6 months was no more than eight points lower than their expectation at study enrollment. The primary analysis compared WHOQOL-BREF domain scores (range, 0-100) at 6 months after discharge in patients with met vs unmet health expectations using the nonparametric Mann-Whitney U test. Secondary analysis modeled WHOQOL-BREF domain scores using multivariate regression, and sensitivity analyses assessed QoL using EQ-5D-5L index values., Results: In the primary analysis, QoL was significantly better among participants with met vs unmet health expectations across all domains of the WHOQOL-BREF: physical health (estimated difference in scores: median, 19 [interquartile range (IQR), 12-15]; P < .001), psychological health (median, 12 [IQR, 6-18]; P < .001), social relationships (median, 6 [IQR, 0-13]; P = .02), and environmental health (median, 12 [IQR, 6-13]; P < .001). In multivariate regression, the difference between expected and perceived health remained associated significantly with the physical health domain score., Interpretation: Fulfillment of health expectations is associated with better QoL after ARF, suggesting a mechanism underpinning successful ICU recovery programs that incorporate normalization and expectation management., (Copyright © 2023 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)
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- 2023
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82. Multimodal, patient-centred symptom control: a strategy to replace sedation in the ICU.
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Eikermann M, Needham DM, and Devlin JW
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- Humans, Respiration, Artificial, Conscious Sedation, Critical Care, Hypnotics and Sedatives therapeutic use, Intensive Care Units
- Abstract
Competing Interests: JWD reports research funding from the US National Institutes of Health (NIH; R13185760, R33HL23452, and R21/R33 AG05797), AHRQ (R21HS028485 and 1R01HS029009), BioExcel Therapeutics, and Sedana Medical. DMN reports research funding to his institution and donated amino acid product from Baxter and donated equipment from Enable Me, which were provided with respect to an NIH-funded randomised trial that is not related to the topic of this Comment. ME reports research funding to his institution from Merck.
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- 2023
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83. Post-intensive care syndrome (PICS): recent updates.
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Hiser SL, Fatima A, Ali M, and Needham DM
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An increasing number of patients are surviving critical illness, but some experience new or worsening long-lasting impairments in physical, cognitive and/or mental health, commonly known as post-intensive care syndrome (PICS). The need to better understand and improve PICS has resulted in a growing body of literature exploring its various facets. This narrative review will focus on recent studies evaluating various aspects of PICS, including co-occurrence of specific impairments, subtypes/phenotypes, risk factors/mechanisms, and interventions. In addition, we highlight new aspects of PICS, including long-term fatigue, pain, and unemployment., (© 2023. The Author(s).)
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- 2023
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84. Acute Respiratory Failure Survivors' Feedback on a Phone-based Follow-Up Using a Core Outcome Set.
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Seth B, Kalva T, Eakin MN, Bose S, Mir-Kasimov M, Sevin CM, Jackson JC, Brown SM, Needham DM, and Dinglas VD
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- Humans, Follow-Up Studies, Feedback, Outcome Assessment, Health Care, Survivors, Respiratory Distress Syndrome, Respiratory Insufficiency
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- 2023
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85. Measures for the Core Outcome Set for Research Evaluating Interventions to Prevent and/or Treat Delirium in Critically Ill Adults: An International Consensus Study (Del-COrS).
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Rose L, Blackwood B, Needham DM, Devlin JW, Clarke M, and Burry LD
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To gain consensus on measurement methods for outcomes (delirium occurrence, severity, time to resolution, mortality, health-related quality of life [HrQoL], emotional distress including anxiety, depression, acute stress, and post-traumatic stress disorder, and cognition) of our Core Outcome Set (COS) for trials of interventions to prevent and/or treat delirium in critically ill adults., Design: International consensus process., Setting: Three virtual meetings (April 2021)., Patients/subjects: Critical illness survivors/family, clinicians, and researchers from six Countries., Interventions: None., Measurements and Main Results: Measures (selected based on instrument validity, existing recommendations, and feasibility) and measurement time horizons were discussed. Participants voted on instruments and measurement timing (a priori consensus threshold ≥ 70%). Eighteen stakeholders (28% ICU survivors/family members) participated. We achieved consensus on the Confusion Assessment Method-ICU or Intensive Care Delirium Screening Checklist to measure delirium occurrence and delirium resolution (100%), Hospital Anxiety and Depression Scale for emotional distress (71%), and Montreal Cognitive Assessment-Blind for cognition (83%). We did not achieve consensus on EQ-5D five-level for HrQoL (69%) or its measurement at 6 months. We also did not achieve consensus on the Impact of Event Scale (IES)-Revised or IES-6 for post-traumatic stress (65%) or on measurement instruments for delirium severity incorporating delirium-related emotional distress. We were unable to gain consensus on when to commence and when to discontinue assessing for delirium occurrence and time to resolution, when to determine mortality. We gained consensus that emotional distress and cognition should be measured up to 12 months from hospital discharge., Conclusions: Consensus was reached on measurement instruments for four of seven outcomes in the COS for delirium prevention or treatment trials for critically ill adults. Further work is required to validate instruments for delirium severity that include delirium-related emotional distress., Competing Interests: The authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.)
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- 2023
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86. Fulfillment of Patient Expectations after Acute Respiratory Failure: A Multicenter Prospective Cohort Study.
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Turnbull AE, Lee EM, Dinglas VD, Beesley S, Bose S, Banner-Goodspeed V, Hopkins RO, Jackson JC, Mir-Kasimov M, Sevin CM, Brown SM, and Needham DM
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- Adult, Humans, Prospective Studies, Cohort Studies, Activities of Daily Living, Motivation, Quality of Life, Intensive Care Units, Respiratory Distress Syndrome, Respiratory Insufficiency therapy
- Abstract
Rationale: Discussion of patient expectations for recovery is a component of intensive care unit (ICU) follow-up clinics. However, few studies have formally evaluated recovery-related expectations of ICU survivors. Objectives: To estimate the prevalence of unmet expectations for recovery 6 months after hospital discharge among adult survivors of acute respiratory failure (ARF). Methods: This was a prospective, longitudinal, cohort study of survivors of ARF discharged to home from five U.S. medical centers. Expectations for functional recovery were assessed by asking which activities and instrumental activities of daily living (I/ADLs) survivors expected to perform independently at 6 months. Survivors' expectations for overall health status were assessed using a visual analogue scale ranging from 0 to 100. At 6-month follow-up, participants reported which I/ADLs they could perform independently and rated their overall health status using a 100-point visual analogue scale. We defined a participant's functional expectations as being met if they reported independently performing I/ADLs as expected at hospital discharge. Health expectations were considered to be met when self-rated health status at 6 months was no more than 8 points lower than expected at enrollment. Results: Among 180 enrollees, 169 (94%) were alive, and 160 of these (95%) participated in 6-month follow-up. Functional expectations were met for 71% of participating survivors, and overall health expectations were met for 50%. Expectations for functional independence were high, ranging from 87% (housekeeping) to 99% (using a telephone). General health expectations were variable (median, 85; interquartile range [IQR], 75-95). At 6-month follow-up, self-rated, overall health ranged from 2 to 100 (median, 80; IQR, 60-85). In exploratory analyses, participants with met versus unmet expectations differed most in formal education (functional expectations standardized difference = 0.88; health expectations standardized difference = 0.41). Conclusions: Expectations of survivors of ARF about independent functioning were high and generally met, but half had unmet general health expectations 6 months after discharge. It is difficult to predict whose health expectations will be unmet, but possessing less formal education may be a risk factor. Clinical trial registered with www.clinicaltrials.gov (NCT03797313).
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- 2023
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87. Outpatient Mental Health Follow-up and Recurrent Self-harm and Suicide Among Patients Admitted to the ICU for Self-harm: A Population-based Cohort Study.
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Fernando SM, Pugliese M, McIsaac DI, Qureshi D, Talarico R, Sood MM, Myran DT, Herridge MS, Needham DM, Munshi L, Rochwerg B, Fiest KM, Milani C, Kisilewicz M, Bienvenu OJ, Brodie D, Fan E, Fowler RA, Ferguson ND, Scales DC, Wunsch H, Tanuseputro P, and Kyeremanteng K
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- Adult, Humans, Cohort Studies, Outpatients, Follow-Up Studies, Intensive Care Units, Ontario epidemiology, Self-Injurious Behavior epidemiology, Self-Injurious Behavior psychology, Suicide psychology
- Abstract
Background: Patients surviving an ICU admission for deliberate self-harm are at high risk of recurrent self-harm or suicide after discharge. It is unknown whether mental health follow-up after discharge (with either a family physician or psychiatrist) reduces this risk., Research Question: What is the association between mental health follow-up after discharge and recurrent self-harm among patients admitted to the ICU for intentional self-harm?, Study Design and Methods: Population-based cohort study of consecutive adults (≥ 18 years of age) from Ontario, Canada, who were admitted to ICU because of intentional self-harm between 2009 and 2017. We categorized patients according to follow-up, with 'early follow-up' indicating 1 to 21 days after discharge, 'late follow-up' indicating 22 to 60 days after discharge, and 'no follow-up' indicating no follow-up within 60 days of discharge. We conducted analyses using a cause-specific extended Cox regression model to account for varying time for mental health follow-up relative to the outcomes of interest. The primary outcome was recurrent ICU admission for self-harm within 1 year of discharge., Results: We included 9,569 consecutive adults admitted to the ICU for deliberate self-harm. Compared with receiving no mental health follow-up, both early follow-up (hazard ratio [HR], 1.37; 95% CI, 1.07-1.75) and late follow-up (HR, 1.69; 95% CI, 1.22-2.35) were associated with increased risk in recurrent ICU admission for self-harm. As compared with no follow-up, neither early follow-up (HR, 1.10; 95% CI, 0.70-1.73) nor late follow-up (HR, 1.54; 95% CI, 0.84-2.83) were associated with increased risk of death by suicide., Interpreation: Among adults admitted to the ICU for deliberate self-harm, mental health follow-up after discharge was not associated with reduced risk of recurrent ICU admission for self-harm or death resulting from suicide, and patients seeking outpatient follow-up may be those at highest risk of these outcomes. Future research should focus on additional and novel methods of risk mitigation in this vulnerable population., (Copyright © 2022 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)
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- 2023
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88. Impact of a multifaceted early mobility intervention for critically ill children - the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial.
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Azamfirei R, Mennie C, Dinglas VD, Fatima A, Colantuoni E, Gurses AP, Balas MC, Needham DM, and Kudchadkar SR
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- Adult, Child, Humans, Intensive Care Units, Pediatric, Respiration, Artificial adverse effects, Treatment Outcome, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Critical Illness, Delirium diagnosis, Delirium prevention & control, Delirium etiology
- Abstract
Background: Over 50% of all critically ill children develop preventable intensive care unit-acquired morbidity. Early and progressive mobility is associated with improved outcomes in critically ill adults including shortened duration of mechanical ventilation and improved muscle strength. However, the clinical effectiveness of early and progressive mobility in the pediatric intensive care unit has never been rigorously studied. The objective of the study is to evaluate if the PICU Up! intervention, delivered in real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children. Additionally, the study aims to identify factors associated with reliable PICU Up! delivery., Methods: The PICU Up! trial is a stepped-wedge, cluster-randomized trial of a pragmatic, interprofessional, and multifaceted early mobility intervention (PICU Up!) conducted in 10 pediatric intensive care units (PICUs). The trial's primary outcome is days alive free of mechanical ventilation (through day 21). Secondary outcomes include days alive and delirium- and coma-free (ADCF), days alive and coma-free (ACF), days alive, as well as functional status at the earlier of PICU discharge or day 21. Over a 2-year period, data will be collected on 1,440 PICU patients. The study includes an embedded process evaluation to identify factors associated with reliable PICU Up! delivery., Discussion: This study will examine whether a multifaceted strategy to optimize early mobility affects the duration of mechanical ventilation, delirium incidence, and functional outcomes in critically ill children. This study will provide new and important evidence on ways to optimize short and long-term outcomes for pediatric patients., Trial Registration: ClinicalTrials.gov NCT04989790. Registered on August 4, 2021., (© 2023. The Author(s).)
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- 2023
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89. Interrelationships among workload, illness severity, and function on return to work following acute respiratory distress syndrome.
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Su H, Thompson HJ, Pike K, Kamdar BB, Bridges E, Hosey MM, Hough CL, Needham DM, and Hopkins RO
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- Humans, Workload, Patient Acuity, Return to Work psychology, Respiratory Distress Syndrome
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Background: Inability to return to work (RTW) is common after acute respiratory distress syndrome (ARDS)., Objectives: The aim of this study is to examine interrelationships among pre-ARDS workload, illness severity, and post-ARDS cognitive, psychological, interpersonal, and physical function with RTW at 6 and 12 months after ARDS., Methods: We conducted a secondary analysis using the US multicentre ARDS Network Long-Term Outcomes Study. The US Occupational Information Network was used to determine pre-ARDS workload. The Mini-Mental State Examination and SF-36 were used to measure four domains of post-ARDS function. Analyses used structural equation modeling and mediation analyses., Results: Among 329 previously employed ARDS survivors, 6- and 12-month RTW rates were 52% and 56%, respectively. Illness severity (standardised coefficients range: -0.51 to -0.54, p < 0.001) had a negative effect on RTW at 6 months, whereas function at 6 months (psychological [0.42, p < 0.001], interpersonal [0.40, p < 0.001], and physical [0.43, p < 0.001]) had a positive effect. Working at 6 months (0.79 to 0.72, P < 0.001) had a positive effect on RTW at 12 months, whereas illness severity (-0.32 to -0.33, p = 0.001) and post-ARDS function (psychological [6 months: 0.44, p < 0.001; 12 months: 0.33, p = 0.002], interpersonal [0.44, p < 0.001; 0.22, p = 0.03], and physical abilities [0.47, p < 0.001; 0.33, p = 0.007]) only had an indirect effect on RTW at 12 months mediated through work at 6 months., Conclusions: RTW at 12 months was associated with patients' illness severity; post-ARDS cognitive, psychological, interpersonal, and physical function; and working at 6 months. Among these factors, working at 6 months and function may be modifiable mediators of 12-month post-ARDS RTW. Improving ARDS survivors' RTW may include optimisation of workload after RTW, along with interventions across the healthcare spectrum to improve patients' physical, psychological, and interpersonal function., (Copyright © 2022 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.)
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- 2023
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90. Association Between Unmet Nonmedication Needs After Hospital Discharge and Readmission or Death Among Acute Respiratory Failure Survivors: A Multicenter Prospective Cohort Study.
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Bose S, Groat D, Dinglas VD, Akhlaghi N, Banner-Goodspeed V, Beesley SJ, Greene T, Hopkins RO, Mir-Kasimov M, Sevin CM, Turnbull AE, Jackson JC, Needham DM, and Brown SM
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- Adult, Humans, United States epidemiology, Prospective Studies, Patient Readmission, Cohort Studies, Hospitals, Survivors, Retrospective Studies, Length of Stay, Patient Discharge, Respiratory Insufficiency therapy
- Abstract
Objectives: To characterize early unmet nonmedication discharge needs (UDNs), classified as durable medical equipment (DME), home health services (HHS), and follow-up medical appointments (FUAs) and explore their association with 90-day readmission and mortality among survivors of acute respiratory failure (ARF) who were discharged home., Design: Prospective multicenter cohort study., Setting: Six academic medical centers across United States., Participants: Adult survivors of ARF who required an ICU stay and were discharged home from hospital., Interventions: None. Exposure of interest was the proportion of UDN for the following categories: DME, HHS, and FUA ascertained within 7-28 days after hospital discharge., Measurements and Main Results: Two hundred eligible patients were recruited between January 2019 and August 2020. One-hundred ninety-five patients were included in the analytic cohort: 118 were prescribed DME, 134 were prescribed HHS, and 189 needed at least one FUA according to discharge plans. 98.4% (192/195) had at least one identified nonmedication need at hospital discharge. Median (interquartile range) proportion of unmet needs across three categories were 0 (0-15%) for DME, 0 (0-50%) for HHS, and 0 (0-25%) for FUA, and overall was 0 (0-20%). Fifty-six patients (29%) had 90-day death or readmission. After adjusting for prespecified covariates, having greater than the median level of unmet needs was not associated with an increased risk of readmission or death within 90 days of discharge (risk ratio, 0.89; 0.51-1.57; p = 0.690). Age, hospital length of stay, Acute Physiology and Chronic Health Evaluation II severity of illness score, and Multidimensional Scale Perceived Social Support score were associated with UDN., Conclusions: UDN were common among survivors of ARF but not significantly associated a composite outcome of 90-day readmission or death. Our results highlight the substantial magnitude of UDN and identifies areas especially vulnerable to lapses in healthcare coordination., Competing Interests: Drs. Bose’s, Groat’s, Mir-Kasimov’s, Sevin’s, Needham’s, and Brown’s institutions received funding from the Department of Defense (DoD). Dr. Dinglas received funding from Healthy Designs and the National Center for Advancing Translational Sciences Trials Innovation Network. Drs. Dinglas and Jackson received support for article research from the National Institutes of Health. Dr. Akhlaghi disclosed work for hire. Dr. Greene received funding from Janssen Pharmaceuticals, Durect Corporation, Pfizer, AstraZeneca, CSL Behring, and Boehringer-Ingelheim. Dr. Mir-Kasimov disclosed government work. Dr. Needham received support for article research from the DoD. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)
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- 2023
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91. Infection control practices and device management when mobilizing critically ill patients.
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Nydahl P, Eggmann S, Katsukawa H, Osterbrink J, Parry SM, Schaller SJ, and Needham DM
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- Humans, Infection Control, Critical Illness, Critical Care
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- 2023
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92. Reliability and validity of the Korean version of the Functional Status Score for the ICU after translation and cross-cultural adaptation.
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Do JG, Suh GY, Won YH, Chang WH, Hiser S, Needham DM, and Chung CR
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- Humans, Reproducibility of Results, Intensive Care Units, Republic of Korea, Surveys and Questionnaires, Psychometrics methods, Cross-Cultural Comparison, Functional Status
- Abstract
Purpose: The Functional Status Score for the Intensive Care Unit (FSS-ICU) evaluates the physical function of ICU patients. The objective of the study was to translate and cross-culturally adapt the FSS-ICU into Korean and assess its reliability and validity., Methods: An expert committee supervised the forward and backward translation process and the final translated version. Experienced physiotherapists assessed patients ( n = 31) from a medical ICU using the Korean version of FSS-ICU. Intra-class correlation coefficients (ICCs) and Bland-Altman's plots were used to evaluate reliability, and Cronbach's alpha for internal consistency. Construct validity was evaluated using Spearman's correlation coefficients., Results: Two physiotherapists in each of the two university hospitals independently assessed 31 medical ICU patients, with a mean FSS-ICU total score of 23 (range: 4-35). The FSS-ICU Korean version demonstrated excellent internal consistency, with Cronbach's alpha of 0.897 for the total FSS-ICU score, and a range of 0.844-0.892 with deletion of each individual activity within the FSS-ICU. Intra-rater and inter-rater reliability were excellent for all of five FSS-ICU activities and the total score, with an ICC range of 0.930-0.993. Bland-Altman's plots revealed a mean difference in FSS-ICU total score of 0.2 (95% limits of agreement: -1.9 to 2.3) between two physiotherapists. The Korean version of FSS-ICU had good convergent and divergent validity with moderate to strong correlation with mobility and muscle strength measures, and poor correlation with unrelated measures., Conclusions: The Korean version of the FSS-ICU showed excellent intra-rater and inter-rater reliability, internal consistency, and construct validity for medical ICU patients. The results of this study, along with prior publications, support that the FSS-ICU Korean version is a valid and reliable assessment tool for the ICU environment.Implications for rehabilitationIntensive care unit patients usually experience decreased muscle strength and physical function.The Korean version of the Functional Status Score for the Intensive Care Unit (FSS-ICU) is suitable for use with Korean speakers and has a valid, reliable measurement tool for physical function of intensive care unit patients.A well-standardized training with videos and written materials is important to ensure correct implementation of the Korean version of the FSS-ICU.
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- 2022
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93. Association of Extracorporeal Membrane Oxygenation With New Mental Health Diagnoses in Adult Survivors of Critical Illness.
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Fernando SM, Scott M, Talarico R, Fan E, McIsaac DI, Sood MM, Myran DT, Herridge MS, Needham DM, Hodgson CL, Rochwerg B, Munshi L, Wilcox ME, Bienvenu OJ, MacLaren G, Fowler RA, Scales DC, Ferguson ND, Combes A, Slutsky AS, Brodie D, Tanuseputro P, and Kyeremanteng K
- Subjects
- Adult, Humans, Female, Middle Aged, Adolescent, Male, Critical Illness therapy, Mental Health, Retrospective Studies, Patient Discharge, Aftercare, Survivors psychology, Outcome Assessment, Health Care, Ontario epidemiology, Extracorporeal Membrane Oxygenation adverse effects, Substance-Related Disorders
- Abstract
Importance: Extracorporeal membrane oxygenation (ECMO) is used as temporary cardiorespiratory support in critically ill patients, but little is known regarding long-term psychiatric sequelae among survivors after ECMO., Objective: To investigate the association between ECMO survivorship and postdischarge mental health diagnoses among adult survivors of critical illness., Design, Setting, and Participants: Population-based retrospective cohort study in Ontario, Canada, from April 1, 2010, through March 31, 2020. Adult patients (N=4462; age ≥18 years) admitted to the intensive care unit (ICU), and surviving to hospital discharge were included., Exposures: Receipt of ECMO., Main Outcomes and Measures: The primary outcome was a new mental health diagnosis (a composite of mood disorders, anxiety disorders, posttraumatic stress disorder; schizophrenia, other psychotic disorders; other mental health disorders; and social problems) following discharge. There were 8 secondary outcomes including incidence of substance misuse, deliberate self-harm, death by suicide, and individual components of the composite primary outcome. Patients were compared with ICU survivors not receiving ECMO using overlap propensity score-weighted cause-specific proportional hazard models., Results: Among 642 survivors who received ECMO (mean age, 50.7 years; 40.7% female), median length of follow-up was 730 days; among 3820 matched ICU survivors who did not receive ECMO (mean age, 51.0 years; 40.0% female), median length of follow-up was 1390 days. Incidence of new mental health conditions among survivors who received ECMO was 22.1 per 100-person years (95% confidence interval [CI] 19.5-25.1), and 14.5 per 100-person years (95% CI, 13.8-15.2) among non-ECMO ICU survivors (absolute rate difference of 7.6 per 100-person years [95% CI, 4.7-10.5]). Following propensity weighting, ECMO survivorship was significantly associated with an increased risk of new mental health diagnosis (hazard ratio [HR] 1.24 [95% CI, 1.01-1.52]). There were no significant differences between survivors who received ECMO vs ICU survivors who did not receive ECMO in substance misuse (1.6 [95% CI, 1.1 to 2.4] per 100 person-years vs 1.4 [95% CI, 1.2 to 1.6] per 100 person-years; absolute rate difference, 0.2 per 100 person-years [95% CI, -0.4 to 0.8]; HR, 0.86 [95% CI, 0.48 to 1.53]) or deliberate self-harm (0.4 [95% CI, 0.2 to 0.9] per 100 person-years vs 0.3 [95% CI, 0.2 to 0.3] per 100 person-years; absolute rate difference, 0.1 per 100 person-years [95% CI, -0.2 to 0.4]; HR, 0.68 [95% CI, 0.21 to 2.23]). There were fewer than 5 total cases of death by suicide in the entire cohort., Conclusions and Relevance: Among adult survivors of critical illness, receipt of ECMO, compared with ICU hospitalization without ECMO, was significantly associated with a modestly increased risk of new mental health diagnosis or social problem diagnosis after discharge. Further research is necessary to elucidate the potential mechanisms underlying this relationship.
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- 2022
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94. Perceived Social Support among Acute Respiratory Failure Survivors in a Multicenter Prospective Cohort Study.
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Turnbull AE, Groat D, Dinglas VD, Akhlaghi N, Bose S, Banner-Goodspeed V, Mir-Kasimov M, Sevin CM, Jackson JC, Beesley S, Hopkins RO, Needham DM, and Brown SM
- Subjects
- Humans, Prospective Studies, Survivors, Social Support, Respiratory Distress Syndrome, Respiratory Insufficiency
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- 2022
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95. Genomes from Uncultivated Pelagiphages Reveal Multiple Phylogenetic Clades Exhibiting Extensive Auxiliary Metabolic Genes and Cross-Family Multigene Transfers.
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Wittmers F, Needham DM, Hehenberger E, Giovannoni SJ, and Worden AZ
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- Humans, Phylogeny, Genome, Viral, Bacteria genetics, Myoviridae genetics, Bacteriophages, Podoviridae
- Abstract
For the abundant marine Alphaproteobacterium Pelagibacter (SAR11), and other bacteria, phages are powerful forces of mortality. However, little is known about the most abundant Pelagiphages in nature, such as the widespread HTVC023P-type, which is currently represented by two cultured phages. Using viral metagenomic data sets and fluorescence-activated cell sorting, we recovered 80 complete, undescribed Podoviridae genomes that form 10 phylogenomically distinct clades (herein, named Clades I to X) related to the HTVC023P-type. These expanded the HTVC023P-type pan-genome by 15-fold and revealed 41 previously unknown auxiliary metabolic genes (AMGs) in this viral lineage. Numerous instances of partner-AMGs (colocated and involved in related functions) were observed, including partners in nucleotide metabolism, DNA hypermodification, and Curli biogenesis. The Type VIII secretion system (T8SS) responsible for Curli biogenesis was identified in nine genomes and expanded the repertoire of T8SS proteins reported thus far in viruses. Additionally, the identified T8SS gene cluster contained an iron-dependent regulator (FecR), as well as a histidine kinase and adenylate cyclase that can be implicated in T8SS function but are not within T8SS operons in bacteria. While T8SS are lacking in known Pelagibacter , they contribute to aggregation and biofilm formation in other bacteria. Phylogenetic reconstructions of partner-AMGs indicate derivation from cellular lineages with a more recent transfer between viral families. For example, homologs of all T8SS genes are present in syntenic regions of distant Myoviridae Pelagiphages, and they appear to have alphaproteobacterial origins with a later transfer between viral families. The results point to an unprecedented multipartner-AMG transfer between marine Myoviridae and Podoviridae. Together with the expansion of known metabolic functions, our studies provide new prospects for understanding the ecology and evolution of marine phages and their hosts. IMPORTANCE One of the most abundant and diverse marine bacterial groups is Pelagibacter . Phages have roles in shaping Pelagibacter ecology; however, several Pelagiphage lineages are represented by only a few genomes. This paucity of data from even the most widespread lineages has imposed limits on the understanding of the diversity of Pelagiphages and their impacts on hosts. Here, we report 80 complete genomes, assembled directly from environmental data, which are from undescribed Pelagiphages and render new insights into the manipulation of host metabolism during infection. Notably, the viruses have functionally related partner genes that appear to be transferred between distant viruses, including a suite that encode a secretion system which both brings a new functional capability to the host and is abundant in phages across the ocean. Together, these functions have important implications for phage evolution and for how Pelagiphage infection influences host biology in manners extending beyond canonical viral lysis and mortality.
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- 2022
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96. Development and Evaluation of an Intensive Care Unit Video Series to Educate Staff on Delirium Detection.
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Kamdar BB, Makhija H, Cotton SA, Fine J, Pollack D, Reyes PA, Novelli F, Malhotra A, Needham DM, and Martin JL
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Background: Delirium affects up to 80% of patients who are mechanically ventilated in the intensive care unit (ICU) but often goes undetected because of incomplete and/or inaccurate clinician evaluation and documentation. A lack of effective, feasible, and sustainable educational methods represents a key barrier to efforts to optimize, scale, and sustain delirium detection competencies. Progress with such barriers may be addressed with asynchronous video-based education., Objective: To evaluate a novel ICU Delirium Video Series for bedside providers via a knowledge assessment quiz and a feedback questionnaire., Methods: An interdisciplinary team scripted and filmed an educational ICU Delirium Video Series, providing detailed instruction on delirium detection using the validated CAM-ICU (Confusion Assessment Method for the ICU). A cohort of bedside nurses subsequently viewed and evaluated the ICU Delirium Video Series using a feedback questionnaire and a previously developed knowledge assessment quiz pre- and post-video viewing., Results: Twenty nurses from four ICUs viewed the ICU Delirium Video Series and completed the pre-post quiz and questionnaire. Ten (50%) respondents had 10 or more years of ICU experience, and seven (35%) reported receiving no CAM-ICU education locally. After video viewing, overall pre-post scores improved significantly (66% vs. 79%; P < 0.0001). In addition, after video viewing, more nurses reported comfort in their ability to evaluate and manage patients with delirium., Conclusion: Viewing the ICU Delirium Video Series resulted in significant improvements in knowledge and yielded valuable feedback. Asynchronous video-based delirium education can improve knowledge surrounding a key bedside competency., (Copyright © 2022 by the American Thoracic Society.)
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- 2022
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97. Improving patient selection for use of consumer grade physical activity monitors in the hospital.
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Hiser S, Urbanek J, Young DL, McLaughlin KH, Colantuoni E, Brotman DJ, Needham DM, and Hoyer E
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- Adult, Humans, Patient Selection, Walking, Hospitals, Activities of Daily Living, Exercise
- Abstract
Background: Bedrest is toxic for inpatients and consumer grade physical activity monitors offer an economical solution to monitor patient ambulation. But these devices may not be accurate in debilitated hospitalized patients who frequently ambulate very slowly., Objective: To determine whether measures of physical capacity can help identify inpatients for whom wearable physical activity monitors may accurately measure step count., Methods: Prospective observational study of 54 adult inpatients with acute neurological diagnoses. Patients were assessed using 2 physical capacity assessments (Activity Measure for Post-Acute Care Inpatient Mobility Short Form [AM-PAC IMSF] and Katz Activities of Daily Living [ADL] scale). They also completed a 2-minute walk test (2MWT) wearing a consumer grade physical activity monitor., Results: The wearable activity monitor recorded steps (initiated) in 33 (61%) of the inpatients, and for 94% of inpatients with gait speeds >0.43 m/s. Physical capacity assessments correlated well with gait speed, AM-PAC IMSF r = 0.7, and Katz ADL r = 0.6, p < 0.05. When the physical activity monitor initiated, the mean absolute percent error (SD) comparing device calculated steps to observed steps, was 10% (13). AM-PAC IMSF (T-score >45) and Katz ADL (>5) cutoff scores identified inpatients for whom physical activity monitors initiated with a sensitivity of 94 and 91%, respectively., Conclusions: Physical capacity assessments, such as AM-PAC, and Katz ADL, may be a useful and feasible screening strategy to help identify inpatients where wearable physical activity monitors can measure their mobility., Competing Interests: Conflicts of interest None., (Copyright © 2022 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2022
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98. The microbiome of a bacterivorous marine choanoflagellate contains a resource-demanding obligate bacterial associate.
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Needham DM, Poirier C, Bachy C, George EE, Wilken S, Yung CCM, Limardo AJ, Morando M, Sudek L, Malmstrom RR, Keeling PJ, Santoro AE, and Worden AZ
- Subjects
- Animals, Bacteria, Humans, Pacific Ocean, Type IV Secretion Systems, Choanoflagellata, Microbiota
- Abstract
Microbial predators such as choanoflagellates are key players in ocean food webs. Choanoflagellates, which are the closest unicellular relatives of animals, consume bacteria and also exhibit marked biological transitions triggered by bacterial compounds, yet their native microbiomes remain uncharacterized. Here we report the discovery of a ubiquitous, uncultured bacterial lineage we name Candidatus Comchoanobacterales ord. nov., related to the human pathogen Coxiella and physically associated with the uncultured marine choanoflagellate Bicosta minor. We analyse complete 'Comchoano' genomes acquired after sorting single Bicosta cells, finding signatures of obligate host-dependence, including reduction of pathways encoding glycolysis, membrane components, amino acids and B-vitamins. Comchoano encode the necessary apparatus to import energy and other compounds from the host, proteins for host-cell associations and a type IV secretion system closest to Coxiella's that is expressed in Pacific Ocean metatranscriptomes. Interactions between choanoflagellates and their microbiota could reshape the direction of energy and resource flow attributed to microbial predators, adding complexity and nuance to marine food webs., (© 2022. The Author(s).)
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- 2022
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99. Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE).
- Author
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Davies TW, van Gassel RJJ, van de Poll M, Gunst J, Casaer MP, Christopher KB, Preiser JC, Hill A, Gundogan K, Reintam-Blaser A, Rousseau AF, Hodgson C, Needham DM, Castro M, Schaller S, McClelland T, Pilkington JJ, Sevin CM, Wischmeyer PE, Lee ZY, Govil D, Li A, Chapple L, Denehy L, Montejo-González JC, Taylor B, Bear DE, Pearse R, McNelly A, Prowle J, and Puthucheary ZA
- Subjects
- Adult, Delphi Technique, Humans, Multiple Organ Failure, Outcome Assessment, Health Care, Research Design, Treatment Outcome, Activities of Daily Living, Critical Illness therapy
- Abstract
Background: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients., Methods: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered 'essential' were taken through the second stage of the Delphi and a subsequent consensus meeting., Results: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered 'essential' at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core 'essential' measurement instruments reached consensus for survival and activities of daily living, and 'recommended' measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for 'recommended,' but not 'essential,' to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction)., Conclusion: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults., (© 2022. The Author(s).)
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- 2022
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100. A comparative study of flow cytometry-sorted communities and shotgun viral metagenomics in a Singapore municipal wastewater treatment plant.
- Author
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Gu X, Yang Y, Mao F, Lee WL, Armas F, You F, Needham DM, Ng C, Chen H, Chandra F, and Gin KY
- Abstract
Traditional or "bulk" viral enrichment and amplification methods used in viral metagenomics introduce unavoidable bias in viral diversity. This bias is due to shortcomings in existing viral enrichment methods and overshadowing by the more abundant viral populations. To reduce the complexity and improve the resolution of viral diversity, we developed a strategy coupling fluorescence-activated cell sorting (FACS) with random amplification and compared this to bulk metagenomics. This strategy was validated on both influent and effluent samples from a municipal wastewater treatment plant using the Modified Ludzack-Ettinger (MLE) process as the treatment method. We found that DNA and RNA communities generated using bulk samples were mostly different from those derived following FACS for both treatments before and after MLE. Before MLE treatment, FACS identified five viral families and 512 viral annotated contigs. Up to 43% of mapped reads were not detected in bulk samples. Nucleo-cytoplasmic large DNA viral families were enriched to a greater extent in the FACS-coupled subpopulations compared with bulk samples. FACS-coupled viromes captured a single-contig viral genome associated with Anabaena phage, which was not observed in bulk samples or in FACS-sorted samples after MLE. These short metagenomic reads, which were assembled into a high-quality draft genome of 46 kbp, were found to be highly dominant in one of the pre-MLE FACS annotated virome fractions (57.4%). Using bulk metagenomics, we identified that between Primary Settling Tank and Secondary Settling Tank viromes, Virgaviridae , Astroviridae , Parvoviridae , Picobirnaviridae , Nodaviridae , and Iridoviridae were susceptible to MLE treatment. In all, bulk and FACS-coupled metagenomics are complementary approaches that enable a more thorough understanding of the community structure of DNA and RNA viruses in complex environmental samples, of which the latter is critical for increasing the sensitivity of detection of viral signatures that would otherwise be lost through bulk viral metagenomics., Competing Interests: The authors declare no conflict of interest., (© 2022 The Authors. iMeta published by John Wiley & Sons Australia, Ltd on behalf of iMeta Science.)
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- 2022
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