Low Incidence of Postoperative Respiratory Depression with Oliceridine Compared to Morphine: A Retrospective Chart Analysis

Background. Oliceridine, an investigational IV opioid, is a first-in-class G-protein selective agonist at the μ-opioid receptor. The G-protein selectivity results in potent analgesia with less recruitment of β-arrestin, a signaling pathway associated with opioid-related adverse events (ORAEs). In randomized controlled studies in both hard and soft tissue models yielding surgical pain, oliceridine provided effective analgesia with a potential for an improved safety and tolerability profile at equianalgesic doses to morphine. The phase 3, open-label, single-arm, multicenter ATHENA trial demonstrated the safety, tolerability, and effectiveness of oliceridine in moderate to severe acute pain in a broad range of patients undergoing surgery or with painful medical conditions warranting use of an IV opioid. This retrospective, observational chart review study compared respiratory depression events associated with oliceridine administration as found in the ATHENA trial to a control cohort treated with conventional opioids. Methods. Patients at 18 years of age or older, who underwent colorectal, orthopedic, cardiothoracic, bariatric, or general surgeries between June 2015 and May 2017 in 11 sites participating in the ATHENA trial who received postoperative analgesia either with IV oliceridine or with IV conventional opioids (e.g., morphine alone or in combination with other opioids) (CO cohort); and had a hospital stay >48 hours, were included in this retrospective analysis. Data from the ATHENA trial was used for the oliceridine cohort; and additional baseline characteristics were collected from medical charts. Data from medical charts were collected for all CO cohort patients. The two cohorts were balanced using an inverse probability weighting method. The primary outcome was the incidence of operationally defined opioid-induced respiratory depression (OIRD) in the two cohorts. Secondary outcomes included between-group comparison of the incidence of OIRD events among a subset of high-risk patients. Results. OIRD was significantly less in the oliceridine cohort compared to the CO cohort (8.0% vs. 30.7%; odds ratio: 0.139) (95% confidence interval [CI] 0.09–0.22; P < 0.0001 ). Likewise, the incidence of OIRD was lower among high-risk patients in the oliceridine cohort (9.1% vs. 34.7%; odds ratio: 0.136) (95% CI [0.09–0.22]; P < 0.0001 ) compared to the CO cohort. Conclusion. In this retrospective chart review study, patients receiving IV oliceridine for moderate to severe acute pain demonstrated a lower incidence of treatment emergent OIRD compared to patients who were treated with IV morphine either alone or with concomitant administration of other opioids.

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Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring

Case Medical Research ◽

10.31525/ct1-nct04017702 ◽

2019 ◽

Author(s):

Keyword(s):

High Risk ◽

Respiratory Depression ◽

Minute Ventilation ◽

High Risk Patients ◽

Ventilation Monitoring ◽

Risk Patients

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Audio-guided self-hypnosis for reduction of claustrophobia during MR imaging: results of an observational 2-group study

European Radiology ◽

10.1007/s00330-021-07887-w ◽

2021 ◽

Author(s):

Adriane E. Napp ◽

Torsten Diekhoff ◽

Olf Stoiber ◽

Judith Enders ◽

Gerd Diederichs ◽

...

Keyword(s):

High Risk ◽

Mr Imaging ◽

Odds Ratio ◽

Control Group ◽

Waiting Room ◽

High Risk Patients ◽

Imaging Results ◽

Before And After ◽

Risk Patients ◽

And Coping

Abstract Objectives To evaluate the influence of audio-guided self-hypnosis on claustrophobia in a high-risk cohort undergoing magnetic resonance (MR) imaging. Methods In this prospective observational 2-group study, 55 patients (69% female, mean age 53.6 ± 13.9) used self-hypnosis directly before imaging. Claustrophobia included premature termination, sedation, and coping actions. The claustrophobia questionnaire (CLQ) was completed before self-hypnosis and after MR imaging. Results were compared to a control cohort of 89 patients examined on the same open MR scanner using logistic regression for multivariate analysis. Furthermore, patients were asked about their preferences for future imaging. Results There was significantly fewer claustrophobia in the self-hypnosis group (16%; 9/55), compared with the control group (43%; 38/89; odds ratio .14; p = .001). Self-hypnosis patients also needed less sedation (2% vs 16%; 1/55 vs 14/89; odds ratio .1; p = .008) and non-sedation coping actions (13% vs 28%; 7/55 vs 25/89; odds ratio .3; p = .02). Self-hypnosis did not influence the CLQ results measured before and after MR imaging (p = .79). Self-hypnosis reduced the frequency of claustrophobia in the subgroup of patients above an established CLQ cut-off of .33 from 47% (37/78) to 18% (9/49; p = .002). In the subgroup below the CLQ cut-off of 0.33, there were no significant differences (0% vs 9%, 0/6 vs 1/11; p = 1.0). Most patients (67%; 35/52) preferred self-hypnosis for future MR examinations. Conclusions Self-hypnosis reduced claustrophobia in high-risk patients undergoing imaging in an open MR scanner and might reduce the need for sedation and non-sedation coping actions. Key Points • Forty percent of the patients at high risk for claustrophobia may also experience a claustrophobic event in an open MR scanner. • Self-hypnosis while listening to an audio in the waiting room before the examination may reduce claustrophobic events in over 50% of patients with high risk for claustrophobia. • Self-hypnosis may also reduce the need for sedation and other time-consuming non-sedation coping actions and is preferred by high-risk patients for future examinations.

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Modified Models for Predicting Malignancy Using Ultrasound Characters Have High Accuracy in Thyroid Nodules With Small Size

Frontiers in Molecular Biosciences ◽

10.3389/fmolb.2021.752417 ◽

2021 ◽

Vol 8 ◽

Author(s):

Shan Jiang ◽

Qingji Xie ◽

Nan Li ◽

Haizhen Chen ◽

Xi Chen

Keyword(s):

High Risk ◽

Thyroid Carcinoma ◽

Odds Ratio ◽

Thyroid Nodules ◽

American Thyroid Association ◽

High Risk Patients ◽

Malignancy Risk ◽

Association Management ◽

Risk Patients ◽

Ultrasound Features

To assess the malignancy risk of thyroid nodules, ten ultrasound characteristics are suggested as key diagnostic markers. The European Thyroid Association Guidelines (EU-TIRADS) and 2015 American Thyroid Association Management Guidelines (2015ATA) are mainly used for ultrasound malignancy risk stratification, but both are less accurate and do not appropriatetly classify high risk patients in clinical examination. Previous studies focus on papillary thyroid carcinoma (PTC), but follicular thyroid carcinoma (FTC) and medullary thyroid carcinoma (MTC) remained to be characterized. Thus, this study aimed to determine the diagnostic accuracy and establish models using all ultrasound features including the nodule size for predicting the malignancy of thyroid nodules (PTC, FTC, and MTC) in China. We applied logistic regression to the data of 1,500 patients who received medical treatment in Shanghai and Fujian. Ultrasound features including taller-than-wide shape and invasion of the thyroid capsule showed high odds ratio (OR 19.329 and 4.672) for PTC in this dataset. Invasion of the thyroid also showed the highest odds ratio (OR = 8.10) for MTC. For FTC, the halo sign has the highest odds ratio (OR = 13.40). Four ultrasound features revealed distinct OR in PTC nodule groups with different sizes. In this study, we constructed a logistic model with accuracy up to 80%. In addition, this model revealed more accuracy than TIRADS in 4b and 4c category nodules. Hence, this model could well predict malignancy in small nodules and classify high-risk patients.

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Efficacy of Dosimetric Versus Empiric Prescribed Activity of 131I for Therapy of Differentiated Thyroid Cancer

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2011-0494 ◽

2011 ◽

Vol 96 (10) ◽

pp. 3217-3225 ◽

Cited By ~ 54

Author(s):

Joanna Klubo-Gwiezdzinska ◽

Douglas Van Nostrand ◽

Frank Atkins ◽

Kenneth Burman ◽

Jacqueline Jonklaas ◽

...

Keyword(s):

Thyroid Cancer ◽

Side Effects ◽

High Risk ◽

Confidence Interval ◽

Odds Ratio ◽

Differentiated Thyroid Cancer ◽

Progression Free Survival ◽

Response To Treatment ◽

High Risk Patients ◽

Risk Patients

Abstract Background: The optimal management of high-risk patients with differentiated thyroid cancer (DTC) consists of thyroidectomy followed by radioiodine (131I) therapy. The prescribed activity of 131I can be determined using two approaches: 1) empiric prescribed activity of 131I (E-Rx); and 2) dosimetry-based prescribed activity of 131I (D-Rx). Aim: The aim of the study was to compare the relative treatment efficacy and side effects of D-Rx vs. E-Rx. Methods: A retrospective analysis was performed of patients with distant metastases and/or locoregionally advanced radioiodine-avid DTC who were treated with either D-Rx or E-Rx. Response to treatment was based on RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Results: The study group consisted of 87 patients followed for 51 ± 35 months, of whom 43 were treated with D-Rx and 44 with E-Rx. Multivariate analysis, controlling for age, gender, and status of metastases revealed that the D-Rx group tended to be 70% less likely to progress (odds ratio, 0.29; 95% confidence interval, 0.087–1.02; P = 0.052) and more likely to obtain complete response (CR) compared to the E-Rx group (odds ratio, 8.2; 95% confidence interval, 1.2–53.5; P = 0.029). There was an association in the D-Rx group between the observed CR and percentage of maximum tolerable activity given as a first treatment of 131I (P = 0.030). The advantage of D-Rx was specifically apparent in the locoregionally advanced group because CR was significantly higher in D-Rx vs. E-Rx in this group of patients (35.7 vs. 3.3%; P = 0.009). The rates of partial response, stable disease, and progression-free survival, as well as the frequency of side effects, were not significantly different between the two groups. Conclusion: Higher efficacy of D-Rx with a similar safety profile compared to E-Rx supports the rationale for employing individually prescribed activity in high-risk patients with DTC.

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Postoperative complications and 90-day mortality in radical cystectomy in high-risk patients: A monocentric retrospective observational study

Urologia Journal ◽

10.1177/0391560317751600 ◽

2018 ◽

Vol 85 (3) ◽

pp. 111-117 ◽

Cited By ~ 5

Author(s):

Carlo Pavone ◽

Luigi Candela ◽

Dario Fontana ◽

Alchiede Simonato

Keyword(s):

High Risk ◽

Postoperative Complications ◽

Observational Study ◽

Radical Cystectomy ◽

Charlson Comorbidity Index ◽

Odds Ratio ◽

Retrospective Observational Study ◽

High Risk Patients ◽

Risk Patients ◽

Comorbidity Index

Aim: Assessing the incidence of immediate postoperative complications and 90-day mortality in high-risk patients who have undergone radical cystectomy; evaluating the correlation between preoperative conditions and surgery outcomes. Materials and methods: This is a monocentric retrospective observational study in which data of 65 patients have been analyzed. High-risk criteria: (a) Age ≥75 years, (b) obesity, (c) age-adjusted Charlson Comorbidity Index ≥8, (d) anemic status, and (e) pT ≥3. More than 50% of patients had two or more “high-risk” indicators. Postoperative complications were assessed through Clavien–Dindo classification. Results: Average age of patients was 70.4 years, average age-adjusted Charlson Comorbidity Index was 5.8, and average body mass index was 27.5. In 28% of patients, no complications arose, while in 46% grades I–II complications according to Clavien–Dindo occurred, in 23% grades III–IV complications occurred, and in 3% of the patients, death arose in the immediate postoperative period (grade V). Overall, 90-day mortality rate after surgery was 12.3%. The age ≥75 years and an age-adjusted Charlson Comorbidity Index score ≥8 have shown to be risk factors for the onset of severe complications (odds ratio = 3.54, p = 0.028 and odds ratio = 4.7, p = 0.026), while preoperative anemic status was a risk factor for complications in general (odds ratio = 4.1, p = 0.015). No analyzed parameter was a predictor of 90-day mortality ( p > 0.05). Conclusion: Immediate postoperative complications and 90-day mortality in radical cystectomy in high-risk patients remain significant, but still in line with the data in the literature on comparable populations. Some of the preoperative parameters were able to predict the outcomes of the intervention with regard to the onset of complications but not to the 90-day mortality.

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Which Out-of-Hospital Cardiac Arrest Patients without ST-Segment Elevation Benefit from Early Coronary Angiography? Results from the Korean Hypothermia Network Prospective Registry

Journal of Clinical Medicine ◽

10.3390/jcm10030439 ◽

2021 ◽

Vol 10 (3) ◽

pp. 439

Author(s):

Hwan Song ◽

Hyo Kim ◽

Kyu Park ◽

Soo Kim ◽

Won Kim ◽

...

Keyword(s):

Cardiac Arrest ◽

High Risk ◽

Coronary Angiography ◽

Odds Ratio ◽

Adjusted Odds Ratio ◽

High Risk Patients ◽

Neurologic Outcomes ◽

Risk Patients ◽

Good Neurologic Outcome ◽

Hospital Cardiac Arrest

The effect of early coronary angiography (CAG) in out-of-hospital cardiac arrest (OHCA) patients without ST-elevation (STE) is still controversial. It is not known which subgroups of patients without STE are the most likely to benefit. The objective of this study was to evaluate the association between emergency CAG and neurologic outcomes and identify subgroups with improved outcomes when emergency CAG was performed. This prospective, multicenter, observational cohort study was based on data from the Korean Hypothermia Network prospective registry (KORHN-PRO) 1.0. Adult OHCA patients who were treated with targeted temperature management (TTM) without any obvious extracardiac cause were included. Patients were dichotomized into early CAG (≤24 h) and no early CAG (>24 h or not performed) groups. High-risk patients were defined as having the Global Registry of Acute Coronary Events (GRACE) score > 140, time from collapse to return of spontaneous circulation (ROSC) > 30 min, lactate level > 7.0 mmol/L, arterial pH < 7.2, cardiac enzyme elevation and ST deviation. The primary outcome was good neurologic outcome at 6 months after OHCA. Of the 1373 patients from the KORHN-PRO 1.0 database, 678 patients met the inclusion criteria. The early CAG group showed better neurologic outcomes at 6 months after cardiac arrest (CA) (adjusted odds ratio: 2.21 (1.27–3.87), p = 0.005). This was maintained even after propensity score matching (adjusted odds ratio: 2.23 (1.39–3.58), p < 0.001). In the subgroup analysis, high-risk patients showed a greater benefit from early CAG. In contrast, no significant association was found in low-risk patients. Early CAG was associated with good neurologic outcome at 6 months after CA and should be considered in high-risk patients.

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Validation of an Automated Surveillance Approach for Drain-Related Meningitis: A Multicenter Study

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2014.5 ◽

2015 ◽

Vol 36 (1) ◽

pp. 65-75 ◽

Cited By ~ 7

Author(s):

Maaike S. M. van Mourik ◽

Annet Troelstra ◽

Jan Willem Berkelbach van der Sprenkel ◽

Marischka C. E. van der Jagt-Zwetsloot ◽

Jolande H. Nelson ◽

...

Keyword(s):

Cerebrospinal Fluid ◽

High Risk ◽

Prediction Model ◽

Chart Review ◽

Routine Care ◽

High Risk Patients ◽

Neurosurgical Patients ◽

Risk Patients ◽

Automated Surveillance ◽

Healthcare Associated

OBJECTIVEManual surveillance of healthcare-associated infections is cumbersome and vulnerable to subjective interpretation. Automated systems are under development to improve efficiency and reliability of surveillance, for example by selecting high-risk patients requiring manual chart review. In this study, we aimed to validate a previously developed multivariable prediction modeling approach for detecting drain-related meningitis (DRM) in neurosurgical patients and to assess its merits compared to conventional methods of automated surveillance.METHODSProspective cohort study in 3 hospitals assessing the accuracy and efficiency of 2 automated surveillance methods for detecting DRM, the multivariable prediction model and a classification algorithm, using manual chart review as the reference standard. All 3 methods of surveillance were performed independently. Patients receiving cerebrospinal fluid drains were included (2012–2013), except children, and patients deceased within 24 hours or with pre-existing meningitis. Data required by automated surveillance methods were extracted from routine care clinical data warehouses.RESULTSIn total, DRM occurred in 37 of 366 external cerebrospinal fluid drainage episodes (12.3/1000 drain days at risk). The multivariable prediction model had good discriminatory power (area under the ROC curve 0.91–1.00 by hospital), had adequate overall calibration, and could identify high-risk patients requiring manual confirmation with 97.3% sensitivity and 52.2% positive predictive value, decreasing the workload for manual surveillance by 81%. The multivariable approach was more efficient than classification algorithms in 2 of 3 hospitals.CONCLUSIONSAutomated surveillance of DRM using a multivariable prediction model in multiple hospitals considerably reduced the burden for manual chart review at near-perfect sensitivity.Infect Control Hosp Epidemiol 2015;36(1): 65–75

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Clinical Interventions to Prevent Tumour Lysis Syndrome in Hematologic Malignancy: A Multisite Retrospective Chart Review

The Canadian Journal of Hospital Pharmacy ◽

10.4212/cjhp.v72i6.2943 ◽

2019 ◽

Vol 72 (6) ◽

Author(s):

Sarah McKenna ◽

Alexandra Cheung ◽

Amanda Wolfe ◽

Brenda L Coleman ◽

Michael E Detsky ◽

...

Keyword(s):

High Risk ◽

Chart Review ◽

Hematologic Malignancy ◽

Retrospective Chart Review ◽

Tumour Lysis Syndrome ◽

Intermediate Risk ◽

Preventive Strategies ◽

Tumour Lysis ◽

High Risk Patients ◽

Risk Patients

ABSTRACTBackground: Tumour lysis syndrome (TLS) occurs when lysis of malignant cells causes electrolyte disturbances and potentially organ dysfunction. Guidelines recommending preventive therapy according to TLS risk are based on low-quality evidence.Objectives: The primary objective was to characterize utilization of TLS preventive strategies through comprehensive description of current practice. Secondary objectives were to determine TLS incidence, to compare use of preventive strategies among intermediate- and high-risk patients, and to describe TLS treatment strategies.Methods: This retrospective chart review examined data for patients with newly diagnosed hematologic malignancy who were admitted to an oncology centre and/or affiliated intensive care unit between October 2015 and September 2016 in Toronto, Ontario, Canada. Results: Fifty-eight patients (29 at intermediate risk, 29 at high risk) were eligible for inclusion. Use of preventive allopurinol, IV bicarbonate, and furosemide was similar between groups. Rasburicase was more frequently used for high-risk patients (3% [1/29] of intermediate-risk patients versus 36% [9/25] of high-risk patients; p = 0.003). In 4 (14%) of the intermediate-risk patients and 2 (8%) of the high-risk patients, TLS developed during the admission. TLS was observed in 10% (1/10) of patients who received preventive rasburicase and 11% (5/44) of those who did not (p > 0.99), and in 9% (4/45) of patients who received preventive IV bicarbonate and 25% (2/8) of those who did not (p = 0.22). Treatment strategies included rasburicase, IV bicarbonate, furosemide, and renal replacement therapy.Conclusions: In this retrospective chart review, rasburicase was more commonly used for high-risk patients, whereas the use of other agents was similar between risk groups. This pattern of use is inconsistent with guidelines, which recommend that all high-risk patients receive rasburicase. There was no difference in TLS incidence between patients who did and did not receive preventive rasburicase or IV bicarbonate. Further prospective studies are needed to inform management of patients with malignancies who are at intermediate or high risk of TLS.RÉSUMÉContexte : Le syndrome de lyse tumorale (SLT) se produit lorsque la lyse de cellules malignes provoque des perturbations électrolytiques et la dysfonction potentielle d’un organe. Les lignes directrices préconisant une thérapie préventive basée sur le risque de SLT se fondent sur des éléments de preuve de piètre qualité.Objectifs : L’objectif principal consistait à décrire l’adoption des stratégies de prévention du SLT en décrivant précisément la pratique actuelle. Les objectifs secondaires consistaient, quant à eux, à déterminer l’incidence du SLT, à comparer l’utilisation des stratégies de prévention pour les patients présentant un risque élevé et moyen et à décrire les stratégies de traitement du SLT.Méthodes : Cet examen rétrospectif a permis d’examiner les données de patients ayant récemment reçu un diagnostic d’hémopathie maligne et ayant été admis dans un centre d’oncologie ou une unité de soins intensifs affiliée, entre octobre 2015 et septembre 2016 à Toronto (Ontario), au Canada.Résultats : Cinquante-huit patients (29 présentant un risque moyen et 29 un risque élevé) étaient admissibles. L’utilisation d’allopurinol à titre préventif, de bicarbonate par voie intraveineuse et de furosémide était similaire d’un groupe à l’autre. Le rasburicase était plus fréquemment utilisé pour les patients présentant un risque élevé (3 % [1/29] de patients présentant un risque moyen contre 36 % [9/25] de patients présentant un risque élevé; p = 0.003). Quatre (14 %) patients présentant un risque moyen et deux (8 %) présentant un risque élevé ont développé un SLT pendant l’admission. Le SLT a été observé chez 10 % (1/10) des patients ayant reçu du rasburicase à titre préventif et chez 11 % (5/44) des patients qui n’en avaient pas reçu (p > 0,99); il a aussi été observé chez 9 % (4/45) des patients ayant reçu du bicarbonate par voie intraveineuse à titre préventif et chez 25 % (2/8) des patients qui n’en avaient pas reçu (p = 0.22). Les stratégies de traitement comprenaient le rasburicase, le bicarbonate par voie intraveineuse, le furosémide et la thérapie de remplacement rénal.Conclusions : Dans cet examen rétrospectif des dossiers, l’usage du rasburicase était plus fréquent pour les patients présentant un risque élevé, tandis que celui d’autres agents était similaire entre les groupes à risque. Ce schéma d’utilisation n’est pas conforme aux lignes directrices, qui recommandent que tous les patients présentant un risque élevé reçoivent du rasburicase. Aucune différence n’est apparue dans l’incidence du SLT parmi les patients ayant reçu du rasburicase ou du bicarbonate par voie intraveineuse à titre préventif et parmi ceux qui n’en avaient pas reçu. Davantage d’études prospectives sont nécessaires pour mieux connaitre la gestion des patients à haut risque ou ceux qui présentent des risques moyens de SLT, mais qui ont des malignités.

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