Publications by authors named "E Wesley Ely"

576 Publications

Dealing with missing delirium assessments in prospective clinical studies of the critically ill: a simulation study and reanalysis of two delirium studies.

BMC Med Res Methodol 2021 May 6;21(1):97. Epub 2021 May 6.

Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA.

Background: In longitudinal critical care studies, researchers may be interested in summarizing an exposure over time and evaluating its association with a long-term outcome. For example, the number of days a patient has delirium (i.e., brain dysfunction) during their critical care stay is associated with the presence and severity of long-term cognitive problems. In large pragmatic trials and multicenter observational studies, particularly when electronic medical record data is used, the information on daily exposure status may be available at some time points and not at others. Model-based multiple imputation is a well-established, widely adopted method to deal with missing data. But the uncertainty around multiple imputation for summary exposure variables is whether the imputation is to be performed at the summary level or at the daily assessment level.

Methods: We compare the following approaches to imputing and summarizing partially missing longitudinal data: 1) active imputation, where we impute the summary; 2) passive imputation, where we impute the daily missing data, and then compute the summary; 3) ad hoc methods where we assume all missing time points have the a) most or the b) least extreme value; and 4) complete case analysis where only participants with complete data are analyzed. These methods were applied under different missingness mechanisms, varying proportions of missingness, and association of missingness with an auxiliary variable using simulations that closely mirrors real-life critical care data to be relevant to real-world clinical practice. The performance of the approaches were compared using bias of the estimated coefficients, standard error of the estimate and coverage. We also apply these imputation strategies to two datasets in critical care.

Results: Simulations show that all methods performed comparably when the proportion of missingness was small, indicating that in such instances, the gain over using any imputation model is minimal. But as the proportion of missingness increases, the passive imputation approach provides efficient and less biased estimates under the missingness at random and missingness completely at random mechanism.

Conclusions: For longitudinal data where a summary exposure is of interest, we recommend practitioners adopting the passive imputation strategy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12874-021-01274-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8101230PMC
May 2021

Association of Delirium during Critical Illness With Mortality: Multicenter Prospective Cohort Study.

Anesth Analg 2021 Apr 30. Epub 2021 Apr 30.

Department of Anesthesiology, Nashville Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, Tennessee.

Background: The temporal association of delirium during critical illness with mortality is unclear, along with the associations of hypoactive and hyperactive motoric subtypes of delirium with mortality. We aimed to evaluate the relationship of delirium during critical illness, including hypoactive and hyperactive motoric subtypes, with mortality in the hospital and after discharge up to 1 year.

Methods: We analyzed a prospective cohort study of adults with respiratory failure and/or shock admitted to university, community, and Veterans Affairs hospitals. We assessed patients using the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the intensive care unit (ICU) and defined the motoric subtype according to the corresponding Richmond Agitation-Sedation Scale if delirium was present. We used Cox proportional hazard models, adjusted for baseline characteristics, coma, and daily hospital events, to determine whether delirium on a given day predicted mortality the following day in patients in the hospital and also to determine whether delirium presence and duration predicted mortality after discharge up to 1 year in patients who survived to hospital discharge. We performed similar analyses for hypoactive and hyperactive subtypes of delirium.

Results: Among 1040 critically ill patients, 214 (21%) died in the hospital and 204 (20%) died out-of-hospital by 1 year. Delirium was common, occurring in 740 (71%) patients for a median (interquartile range [IQR]) of 4 (2-7) days. Hypoactive delirium occurred in 733 (70%) patients, and hyperactive occurred in 185 (18%) patients, with a median (IQR) of 3 (2-7) days and 1 (1-2) days, respectively. Delirium on a given day (hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.32-6.21; P = .008), in particular the hypoactive subtype (HR, 3.35; 95% CI, 1.51-7.46; P = .003), was independently associated with an increased risk of death the following day in the hospital. Hyperactive delirium was not associated with an increased risk of death in the hospital (HR, 4.00; 95% CI, 0.49-32.51; P = .19). Among hospital survivors, neither delirium presence (HR, 1.01; 95% CI, 0.82-1.24; P = .95) nor duration (HR, 0.99; 95% CI, 0.97-1.01; P = .56), regardless of motoric subtype, was associated with mortality after hospital discharge up to 1 year.

Conclusions: Delirium during critical illness is associated with nearly a 3-fold increased risk of death the following day for patients in the hospital but is not associated with mortality after hospital discharge. This finding appears primarily driven by the hypoactive motoric subtype. The independent relationship between delirium and mortality occurs early during critical illness but does not persist after hospital discharge.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1213/ANE.0000000000005544DOI Listing
April 2021

Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer.

Trials 2021 Apr 29;22(1):314. Epub 2021 Apr 29.

Department of Biostatistics, Vanderbilt University Medical Center, 2525 West End, Suite 1100, Nashville, 37203, TN, USA.

Background: The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019.

Methods And Design: The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio.

Results: The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery.

Conclusion: This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021.

Trial Registration: ClinicalTrials.gov NCT03436290 . Registered on 16 February 2018.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-021-05256-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8082922PMC
April 2021

Associations between caregiver-detected delirium and symptoms of depression and anxiety in family caregivers of critically ill patients: a cross-sectional study.

BMC Psychiatry 2021 04 9;21(1):187. Epub 2021 Apr 9.

Department of Critical Care Medicine, Department of Community Health Sciences, Department of Psychiatry, and O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB, T2N 1N4, Canada.

Background: Witnessing delirium can be distressing for family caregivers (i.e., relatives or friends) of critically ill patients. This study aimed to evaluate associations between caregiver-detected delirium in critically ill patients and depression and anxiety symptoms in their family caregivers.

Methods: Consecutive adult patient-caregiver dyads were enrolled from a 28-bed medical-surgical intensive care unit. Patient delirium was screened for daily by family caregivers using the Sour Seven instrument. Family caregivers completed the Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) instruments daily to assess their own depression and anxiety symptoms. Response feature analysis was used to handle repeated measures. Descriptive statistics and regression analyses were completed.

Results: One hundred forty-seven patient-caregiver dyads were enrolled. Clinically significant symptoms of depression and anxiety occurred in 27% and 35% of family caregivers, respectively. Caregiver-detected delirium occurred in 65% of patients, and was not associated with clinically significant caregiver depression (Odds Ratio [OR] 1.4, 95% Confidence Interval [95%CI] 0.6-3.1) or anxiety (OR 1.2, 95%CI 0.6-2.6) symptoms. When stratified by Sour Seven scores, scores 1-3 and 4-9 were associated with increased symptoms of anxiety (OR 3.1, 95%CI 1.3-7.0) and depression (OR 2.6, 95%CI 1.1-6.1) in family caregivers. Caregiver-detected delirium score was associated with severity of family caregiver anxiety symptoms (coefficient 0.2, 95%CI 0.1-0.4), but not depression symptoms (coefficient 0.2, 95%CI -0.0-0.3).

Conclusions: Caregiver-detected patient delirium was associated with increased depression and anxiety symptoms in family caregivers of critically ill patients. Further randomized research is required to confirm these associations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12888-021-03200-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8035728PMC
April 2021

Risk factors for delirium among hospitalized patients in Zambia.

PLoS One 2021 8;16(4):e0249097. Epub 2021 Apr 8.

University of Zambia School of Medicine, Lusaka, Zambia.

Objective: To identify risk factors for delirium among hospitalized patients in Zambia.

Methods: We conducted a prospective cohort study at the University Teaching Hospital in Lusaka, Zambia, from October 2017 to April 2018. We report associations of exposures including sociodemographic and clinical factors with delirium over the first three days of hospital admission, assessed using a modified Brief Confusion Assessment Method (bCAM).

Findings: 749 patients were included for analysis (mean age, 42.9 years; 64.8% men; 47.3% with HIV). In individual regression analyses of potential delirium risk factors adjusted for age, sex and education, factors significantly associated with delirium included being divorced/widowed (OR 1.64, 95% CI 1.09-2.47), lowest tercile income (OR 1.58, 95% CI 1.04-2.40), informal employment (OR 1.97, 95% CI 1.25-3.15), untreated HIV infection (OR 2.18, 95% CI 1.21-4.06), unknown HIV status (OR 2.90, 95% CI 1.47-6.16), history of stroke (OR 2.70, 95% CI 1.15-7.19), depression/anxiety (OR 1.52, 95% CI 1.08-2.14), alcohol overuse (OR 1.96, 95% CI 1.39-2.79), sedatives ordered on admission (OR 3.77, 95% CI 1.70-9.54), severity of illness (OR 2.00, 95% CI 1.82-2.22), neurological (OR 7.66, 95% CI 4.90-12.24) and pulmonary-system admission diagnoses (OR 1.91, 95% CI 1.29-2.85), and sepsis (OR 2.44, 95% CI 1.51-4.08). After combining significant risk factors into a multivariable regression analysis, severity of illness, history of stroke, and being divorced/widowed remained predictive of delirium (p<0.05).

Conclusion: Among hospitalized adults at a national referral hospital in Zambia, severity of illness, history of stroke, and being divorced/widowed were independently predictive of delirium. Extension of this work will inform future efforts to prevent, detect, and manage delirium in low- and middle-income countries.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0249097PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8031188PMC
April 2021