Development of an Ordinal Scale Treatment Endpoint for Adults Hospitalized With Influenza

Author(s):  
Nelson Lee ◽  
Stephanie W Smith ◽  
David S C Hui ◽  
Ming Ye ◽  
Nathan Zelyas ◽  
...  

Abstract Background An obstacle in influenza therapeutics development is the lack of clinical endpoints, especially in hospitalized patients. A single time-point binary outcome measure is limited by patients’ diverse clinical trajectories and low event rates. Methods A 6-point ordinal scale with ascending clinical status severity (scoring: discharged; subacute care; acute care without/with respiratory failure; intensive care unit [ICU]; death) was proposed to study outcomes of adults hospitalized with influenza. Individual patient data from 2 active surveillance cohorts’ datasets (2015/2016−2017/2018; Edmonton, Hong Kong) was used for evaluation. The impact of neuraminidase inhibitor (NAI) treatment on longitudinal ordinal outcome changes over 30 days was analyzed using mixed-effects ordinal logistic regression and group-based trajectory models. Results Patient (n = 1226) baseline characteristics included age (mean 68.0 years), virus-type (A 78.1%, B 21.9%), respiratory failure (57.2%), ICU admittance (14.4%), and NAI treatment within 5 days of illness (69.2%). Outcomes at 30 days included discharged (75.2%), subacute care (13.7%), acute care (4.5%), and death (6.6%). Two main clinical trajectories were identified, predictive by baseline scoring (mean ± SD, 4.3 ± 0.6 vs 3.5 ± 0.6, P < .001). Improved outcomes with NAI treatment within 5 days were indicated by significantly lower clinical status scores over time (unadjusted odds ratio [OR], 0.53; 95% confidence interval [CI], .41−.69; P < .001; adjusted OR, 0.62; 95% CI, .50−.77; P < .001, for baseline score, age, and within-patient correlations). In subanalysis, influenza vaccination was also associated with lower scores (adjusted OR, 0.67; 95% CI, .50−.90; P = .007). Analyses of binary endpoints showed insignificant results. Conclusions The ordinal outcome scale is a potentially useful clinical endpoint for influenza therapeutic trials, which could account for the diverse clinical trajectories of hospitalized patients, warranting further development.

Author(s):  
Michael Roimi ◽  
Rom Gutman ◽  
Jonathan Somer ◽  
Asaf Ben Arie ◽  
Ido Calman ◽  
...  

Abstract Objective The spread of COVID-19 has led to severe strain on hospital capacity in many countries. We aim to develop a model helping planners assess expected COVID-19 hospital resource utilization based on individual patient characteristics. Materials and Methods We develop a model of patient clinical course based on an advanced multistate survival model. The model predicts the patient's disease course in terms of clinical states—critical, severe, or moderate. The model also predicts hospital utilization on the level of entire hospitals or healthcare systems. We cross-validated the model using a nationwide registry following the day-by-day clinical status of all hospitalized COVID-19 patients in Israel from March 1st to May 2nd, 2020 (n = 2,703). Results Per-day mean absolute errors for predicted total and critical-care hospital-bed utilization were 4.72 ± 1.07 and 1.68 ± 0.40 respectively, over cohorts of 330 hospitalized patients; AUCs for prediction of critical illness and in-hospital mortality were 0.88 ± 0.04 and 0.96 ± 0.04, respectively. We further present the impact of patient influx scenarios on day-by-day healthcare system utilization. We provide an accompanying R software package. Discussion The proposed model accurately predicts total and critical-care hospital utilization. The model enables evaluating impacts of patient influx scenarios on utilization, accounting for the state of currently hospitalized patients and characteristics of incoming patients. We show that accurate hospital-load predictions were possible using only a patient’s age, sex, and day-by-day clinical state (critical, severe or moderate). Conclusion The multistate model we develop is a powerful tool for predicting individual-level patient outcomes and hospital-level utilization.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S51-S51
Author(s):  
Kelsey N Williams ◽  
Ramy H Elshaboury ◽  
Alyssa R Letourneau ◽  
Meagan L Adamsick ◽  
Ronak G Gandhi ◽  
...  

Abstract Background Echinocandin overuse is associated with increased prevalence of non-albicans Candida spp, resistance, and high costs. Prospective review of micafungin prescribing by an Antimicrobial Stewardship Pharmacist (ASP) has shown reduced rates of inappropriate therapy. The aim of this study was to describe ASP’s interventions following introduction of a micafungin time out (MTO) protocol. Methods The approved MTO protocol was implemented in November 2019. Active micafungin orders for hospitalized patients were reviewed Monday through Friday at initiation and on day five. The MTO algorithm assessed micafungin use based on patient risk factors for Candida infection and de-escalation was guided by clinical status, culture data, and susceptibility testing. Micafungin use and ASP’s interventions were reviewed post-implementation between 12/01/2019 and 02/29/2020. Micafungin use was also characterized between 12/01/2018 and 02/28/2019 to serve as a control. Results A random sample of 50 patients who received micafungin for ≥ 48 hours during the pre- and post- protocol periods were included. 39 (78%) and 38 (76%) patients in the pre- and post-MTO cohort had indications for micafungin initiation according to algorithm. In the post-MTO group, 9 (75%) of the 12 micafungin initiations outside of algorithm approval were intervened on successfully by the ASP, increasing appropriate antifungal therapy to 47 (94%) patients. On day five, 18 (50%) and 25 (65.8%) (p=0.17) micafungin orders were according to algorithm in the pre- and post-MTO groups, respectively. Culture data on day five revealed 18 (50%) in the pre-MTO and 13 (34.2%) in the post-MTO group were eligible for de-escalation. An ASP-initiated MTO on day five identified 23 opportunities for antifungal therapy optimization in the post-MTO group. Interventions included de-escalation (13; 61.9%), discontinuation (6; 28.6%), and dose optimization (4; 19%). Of the 23 ASP interventions on day 5, 10 (43.4%) led to micafungin discontinuation or de-escalation, increasing the overall antifungal appropriateness to 35 (92.1%) patients. Conclusion An ASP-initiated MTO can facilitate appropriate and timely optimization of antifungal therapy. The most frequent interventions were de-escalation from micafungin or therapy discontinuation. Disclosures All Authors: No reported disclosures


2019 ◽  
Vol 4 (5) ◽  
pp. 1017-1027 ◽  
Author(s):  
Richard R. Hurtig ◽  
Rebecca M. Alper ◽  
Karen N. T. Bryant ◽  
Krista R. Davidson ◽  
Chelsea Bilskemper

Purpose Many hospitalized patients experience barriers to effective patient–provider communication that can negatively impact their care. These barriers include difficulty physically accessing the nurse call system, communicating about pain and other needs, or both. For many patients, these barriers are a result of their admitting condition and not of an underlying chronic disability. Speech-language pathologists have begun to address patients' short-term communication needs with an array of augmentative and alternative communication (AAC) strategies. Method This study used a between-groups experimental design to evaluate the impact of providing patients with AAC systems so that they could summon help and communicate with their nurses. The study examined patients' and nurses' perceptions of the patients' ability to summon help and effectively communicate with caregivers. Results Patients who could summon their nurses and effectively communicate—with or without AAC—had significantly more favorable perceptions than those who could not. Conclusions This study suggests that AAC can be successfully used in acute care settings to help patients overcome access and communication barriers. Working with other members of the health care team is essential to building a “culture of communication” in acute care settings. Supplemental Material https://doi.org/10.23641/asha.9990962


2020 ◽  
Vol 32 (4) ◽  
pp. 523-532 ◽  
Author(s):  
Praveen V. Mummaneni ◽  
Mohamad Bydon ◽  
John Knightly ◽  
Mohammed Ali Alvi ◽  
Anshit Goyal ◽  
...  

OBJECTIVEDischarge to an inpatient rehabilitation facility or another acute-care facility not only constitutes a postoperative challenge for patients and their care team but also contributes significantly to healthcare costs. In this era of changing dynamics of healthcare payment models in which cost overruns are being increasingly shifted to surgeons and hospitals, it is important to better understand outcomes such as discharge disposition. In the current article, the authors sought to develop a predictive model for factors associated with nonroutine discharge after surgery for grade I spondylolisthesis.METHODSThe authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis who underwent a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multisite study investigating the impact of fusion on clinical and patient-reported outcomes among patients with grade I spondylolisthesis were evaluated. Nonroutine discharge was defined as those who were discharged to a postacute or nonacute-care setting in the same hospital or transferred to another acute-care facility.RESULTSOf the 608 patients eligible for inclusion, 9.4% (n = 57) had a nonroutine discharge (8.7%, n = 53 discharged to inpatient postacute or nonacute care in the same hospital and 0.7%, n = 4 transferred to another acute-care facility). Compared to patients who were discharged to home, patients who had a nonroutine discharge were more likely to have diabetes (26.3%, n = 15 vs 15.7%, n = 86, p = 0.039); impaired ambulation (26.3%, n = 15 vs 10.2%, n = 56, p < 0.001); higher Oswestry Disability Index at baseline (51 [IQR 42–62.12] vs 46 [IQR 34.4–58], p = 0.014); lower EuroQol-5D scores (0.437 [IQR 0.308–0.708] vs 0.597 [IQR 0.358–0.708], p = 0.010); higher American Society of Anesthesiologists score (3 or 4: 63.2%, n = 36 vs 36.7%, n = 201, p = 0.002); and longer length of stay (4 days [IQR 3–5] vs 2 days [IQR 1–3], p < 0.001); and were more likely to suffer a complication (14%, n = 8 vs 5.6%, n = 31, p = 0.014). On multivariable logistic regression, factors found to be independently associated with higher odds of nonroutine discharge included older age (interquartile OR 9.14, 95% CI 3.79–22.1, p < 0.001), higher body mass index (interquartile OR 2.04, 95% CI 1.31–3.25, p < 0.001), presence of depression (OR 4.28, 95% CI 1.96–9.35, p < 0.001), fusion surgery compared with decompression alone (OR 1.3, 95% CI 1.1–1.6, p < 0.001), and any complication (OR 3.9, 95% CI 1.4–10.9, p < 0.001).CONCLUSIONSIn this multisite study of a defined cohort of patients undergoing surgery for grade I spondylolisthesis, factors associated with higher odds of nonroutine discharge included older age, higher body mass index, presence of depression, and occurrence of any complication.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
I. E. Ceyisakar ◽  
N. van Leeuwen ◽  
Diederik W. J. Dippel ◽  
Ewout W. Steyerberg ◽  
H. F. Lingsma

Abstract Background There is a growing interest in assessment of the quality of hospital care, based on outcome measures. Many quality of care comparisons rely on binary outcomes, for example mortality rates. Due to low numbers, the observed differences in outcome are partly subject to chance. We aimed to quantify the gain in efficiency by ordinal instead of binary outcome analyses for hospital comparisons. We analyzed patients with traumatic brain injury (TBI) and stroke as examples. Methods We sampled patients from two trials. We simulated ordinal and dichotomous outcomes based on the modified Rankin Scale (stroke) and Glasgow Outcome Scale (TBI) in scenarios with and without true differences between hospitals in outcome. The potential efficiency gain of ordinal outcomes, analyzed with ordinal logistic regression, compared to dichotomous outcomes, analyzed with binary logistic regression was expressed as the possible reduction in sample size while keeping the same statistical power to detect outliers. Results In the IMPACT study (9578 patients in 265 hospitals, mean number of patients per hospital = 36), the analysis of the ordinal scale rather than the dichotomized scale (‘unfavorable outcome’), allowed for up to 32% less patients in the analysis without a loss of power. In the PRACTISE trial (1657 patients in 12 hospitals, mean number of patients per hospital = 138), ordinal analysis allowed for 13% less patients. Compared to mortality, ordinal outcome analyses allowed for up to 37 to 63% less patients. Conclusions Ordinal analyses provide the statistical power of substantially larger studies which have been analyzed with dichotomization of endpoints. We advise to exploit ordinal outcome measures for hospital comparisons, in order to increase efficiency in quality of care measurements. Trial registration We do not report the results of a health care intervention.


Gut ◽  
2021 ◽  
pp. gutjnl-2021-324879
Author(s):  
Luca Saverio Belli ◽  
Christophe Duvoux ◽  
Paolo Angelo Cortesi ◽  
Rita Facchetti ◽  
Speranta Iacob ◽  
...  

ObjectiveExplore the impact of COVID-19 on patients on the waiting list for liver transplantation (LT) and on their post-LT course.DesignData from consecutive adult LT candidates with COVID-19 were collected across Europe in a dedicated registry and were analysed.ResultsFrom 21 February to 20 November 2020, 136 adult cases with laboratory-confirmed SARS-CoV-2 infection from 33 centres in 11 European countries were collected, with 113 having COVID-19. Thirty-seven (37/113, 32.7%) patients died after a median of 18 (10–30) days, with respiratory failure being the major cause (33/37, 89.2%). The 60-day mortality risk did not significantly change between first (35.3%, 95% CI 23.9% to 50.0%) and second (26.0%, 95% CI 16.2% to 40.2%) waves. Multivariable Cox regression analysis showed Laboratory Model for End-stage Liver Disease (Lab-MELD) score of ≥15 (Model for End-stage Liver Disease (MELD) score 15–19, HR 5.46, 95% CI 1.81 to 16.50; MELD score≥20, HR 5.24, 95% CI 1.77 to 15.55) and dyspnoea on presentation (HR 3.89, 95% CI 2.02 to 7.51) being the two negative independent factors for mortality. Twenty-six patients underwent an LT after a median time of 78.5 (IQR 44–102) days, and 25 (96%) were alive after a median follow-up of 118 days (IQR 31–170).ConclusionsIncreased mortality in LT candidates with COVID-19 (32.7%), reaching 45% in those with decompensated cirrhosis (DC) and Lab-MELD score of ≥15, was observed, with no significant difference between first and second waves of the pandemic. Respiratory failure was the major cause of death. The dismal prognosis of patients with DC supports the adoption of strict preventative measures and the urgent testing of vaccination efficacy in this population. Prior SARS-CoV-2 symptomatic infection did not affect early post-transplant survival (96%).


2021 ◽  
pp. 089719002110282
Author(s):  
Karan Raja ◽  
Nicole Daniel ◽  
Susan Morrison ◽  
Ruben Patel ◽  
Jessica Gerges ◽  
...  

Background: Tocilizumab is an interleukin-6 receptor antagonist hypothesized to blunt the uncontrolled immune response, cytokine release syndrome, in severe COVID-19 and prevent attributable morbidity and mortality. Objective: The objective of this study was to assess the impact of tocilizumab on clinical outcomes in COVID-19-associated cytokine release syndrome. Methods: Single-center, retrospective cohort study assessing sixty-nine adult patients receiving tocilizumab for suspected COVID-19 cytokine release syndrome. The primary outcome was change in WHO clinical status scale on day seven post-dose analyzed using the Wilcoxon signed rank test. Secondary outcomes assessed impact of timing of administration on clinical outcome. Safety analyses included development of neutropenia, thrombocytopenia, transaminitis, and sepsis within 7 days post-dose. Statistical analyses were conducted using Microsoft Excel. Results: No aggregate clinical change was found between day 0 and day 7. Eleven patients improved, twenty-seven worsened, and thirty-one showed no change. Clinical outcomes were weakly correlated with time from symptom onset (rs = 0.21; p = 0.08) or hospital admission (rs = -0.08; p = 0.49) to dose. In-hospital mortality was 63%. Sepsis was diagnosed in 21 patients, five of which were post-dose. Transaminitis, neutropenia, and thrombocytopenia occurred in seven, one, and six patients, respectively. Conclusion: Tocilizumab did not appear to influence clinical outcomes in our study population, irrespective of timing of administration. Adverse events were not considered drug-related.


2021 ◽  
Vol 11 (2) ◽  
pp. 161
Author(s):  
Chong-Chi Chiu ◽  
Jhi-Joung Wang ◽  
Chao-Ming Hung ◽  
Hsiu-Fen Lin ◽  
Hong-Hsi Hsien ◽  
...  

Few papers discuss how the economic burden of patients with stroke receiving rehabilitation courses is related to post-acute care (PAC) programs. This is the first study to explore the economic burden of stroke patients receiving PAC rehabilitation and to evaluate the impact of multidisciplinary PAC programs on cost and functional status simultaneously. A total of 910 patients with stroke between March 2014 and October 2018 were separated into a PAC group (at two medical centers) and a non-PAC group (at three regional hospitals and one district hospital) by using propensity score matching (1:1). A cost–illness approach was employed to identify the cost categories for analysis in this study according to various perspectives. Total direct medical cost in the per-diem-based PAC cohort was statistically lower than that in the fee-for-service-based non-PAC cohort (p < 0.001) and annual per-patient economic burden of stroke patients receiving PAC rehabilitation is approximately US $354.3 million (in 2019, NT $30.5 = US $1). Additionally, the PAC cohort had statistical improvement in functional status vis-à-vis the non-PAC cohort and total score of each functional status before rehabilitation and was also statistically significant with its total score after one-year rehabilitation training (p < 0.001). Early stroke rehabilitation is important for restoring health, confidence, and safe-care abilities in these patients. Compared to the current stroke rehabilitation system, PAC rehabilitation shortened the waiting time for transfer to the rehabilitation ward and it was indicated as an efficient policy for treatment of stroke in saving medical cost and improving functional status.


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