Drug-Related Adverse Events Soar, Add to Hospital Stays

2011 ◽  
Vol 4 (5) ◽  
pp. 27
Author(s):  
MARY ELLEN SCHNEIDER
Keyword(s):  
Adverse Events ◽  
Hospital Stays

Fast track multidiscipline treatment versus conventional treatment for colorectal cancer: The results of a prospective randomized controlled study (FTMDT trial).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 743-743
Author(s):  
Ke-Feng Ding ◽  
Jun Li ◽  
Jiao-Jiao Zhou ◽  
Xiang-Xing Kong ◽  
Jin-Jie He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Laparoscopic Surgery ◽  
Adverse Events ◽  
Open Surgery ◽  
Conventional Treatment ◽  
Fast Track ◽  
Total Hospital ◽  
Perioperative Treatment ◽  
Randomized Controlled ◽  
Hospital Stays

743 Background: Fast Track Multi-Discipline Treatment (FTMDT) integrates fast-track perioperative treatment (laparoscopic or open surgery) plus XELOX adjuvant chemotherapy for colorectal cancer (CRC). This study aimed to verify the effects of FTMDT model and to clarify the value of laparoscopic surgery in fast-track perioperative treatment. Methods: The study (NCT01080547) was a prospective randomized controlled multi-centers study. Group I (FTMDT) received fast-track treatment plus XELOX chemotherapy (Group Ia received laparoscopic surgery and Group Ib received open surgery). Group II (conventional treatment, CT) received conventional treatment plus mFOLFOX6 chemotherapy (Group IIa received laparoscopic surgery and Group IIb received open surgery). The primary endpoint was total hospital stays during treatment. The secondary endpoints included surgical complications, chemotherapy related adverse events, quality of life and hospitalization costs. Results: Between April 2010 and June 2014, 374 patients were enrolled and 342 patients were finally analyzed. The total hospital stays were shorter in FTMDT than CT (median 13 days vs. 23.5 days, P= 0.0001) but similar between Group Ia and Group Ib (median 13 days vs. 14 days, P= 0.1951). The postoperative hospital stays were shorter in FTMDT than CT (median 6 days vs. 9 days, P= 0.0001) but similar between Group Ia and Group Ib (median 6 days vs. 6 days, P= 0.2160). Resume of flatus and defecation was earlier in FTMDT ( P< 0.05) and Group Ia was the earliest. The in-hospital complication rate was lower in FTMDT (6.40% vs. 14.71%, P= 0.014) but similar between Group Ia and Group Ib. The surgery cost of Group Ib was the lowest ( P< 0.05). The rate of chemotherapy related adverse events was similar between FTMDT and CT( P> 0.05). The EORTC QLQ-C30 physical functioning and fatigue in one week postoperative were better in FTMDT than CT( P< 0.05). Conclusions: FTMDT model enhanced the postoperative recovery of CRC patients. On the premise of fast-track perioperative treatment, laparoscopic surgery showed minor advantage over open surgery which had economic advantages. Clinical trial information: NCT01080547.

scholarly journals Indicators of healthcare results: analysis of adverse events during hospital stays

2008 ◽  
Vol 16 (4) ◽  
pp. 746-751 ◽  
Author(s):  
Camila Cristina Pires Nascimento ◽  
Maria Cecília Toffoletto ◽  
Leilane Andrade Gonçalves ◽  
Walkíria das Graças Freitas ◽  
Katia Grillo Padilha
Keyword(s):  
Intensive Care ◽  
Adverse Events ◽  
Intensive Care Units ◽  
Medication Errors ◽  
Nursing Interventions ◽  
Similar Distribution ◽  
Nasogastric Tubes ◽  
Hospital Stays ◽  
The Moment ◽  
Nursing Professionals

This quantitative, retrospective study aimed to characterize adverse events (AE) in Intensive Care Units (ICU), Semi-Intensive Care Units (SCU) and Inpatient Units (IU), regarding nature, type, day of the week and nursing professionals / patient ratio at the moment of occurrence; as well as to identify nursing interventions after the event and AE rates. The study was performed at a private hospital in the city of São Paulo, Brazil. Two hundred twenty-nine AE were notified. The predominant events were related to nasogastric tubes (NGT) (57.6%), followed by patient fall (16.6%) and medication errors (14.8%). The nursing professionals /patient ratio at the moment of the event was 1:2 for the ICU, 1:3 for the SCU and 1:4 for the IU. A similar distribution was observed for the other days of the week. The nursing interventions were: repositioning the NGT (83.2%) and communication of the occurrence to the physician in case of medication errors (47.6%) and falls (55.2%). The highest AE rate was related to NGT.

scholarly journals Orthognathic Surgical Rehabilitation in a Patient with Nemaline Rod Myopathy: A Case Report

2020 ◽  
Vol 4 (5) ◽  
pp. 1-6
Author(s):  
Faisal A Quereshy ◽  
Keyword(s):  
Case Report ◽  
Adverse Events ◽  
Surgical Planning ◽  
Surgical Intervention ◽  
Treatment Plan ◽  
Maxillofacial Surgery ◽  
Oral And Maxillofacial Surgery ◽  
Hospital Stays ◽  
Staged Treatment ◽  
Disease Specific

A case report of the 5-year treatment path of a female patient with Nemaline Rod Myopathy treated by the Department of Oral and Maxillofacial Surgery and the Department of Craniofacial Orthodontics at the Case Western Reserve University in Cleveland, Ohio is presented. Myopathic patients present with disease-specific facies that requires extensive surgical intervention. Additionally, these patients are medically complex, requiring extensive pre and post-surgical planning to avoid adverse events. Our multi-disciplinary and multi-staged treatment plan required no extended post-surgical hospital stays or emergent interventions and she was to reach her stated goal of closing her lips and speaking.

scholarly journals Risk factors for determining length of intensive care unit and hospital stays following correction of cervical deformity: evaluation of early severe adverse events

2020 ◽  
pp. 1-12
Author(s):  
Rushikesh S. Joshi ◽  
Darryl Lau ◽  
Alexander F. Haddad ◽  
Vedat Deviren ◽  
Christopher P. Ames
Keyword(s):  
Risk Factors ◽  
Intensive Care Unit ◽  
Multivariate Analysis ◽  
Intensive Care ◽  
Adverse Events ◽  
Cervical Deformity ◽  
Female Sex ◽  
Hospital Stays ◽  
The Mean ◽  
Severe Adverse Events

OBJECTIVECorrection of rigid cervical deformities can be associated with high complication rates and result in prolonged intensive care unit (ICU) and hospital stays. In this study, the authors aimed to examine the risk factors contributing to length of stay (LOS) in both the hospital and ICU following adult cervical deformity (ACD) surgery and to identify severe adverse events that occurred in this setting.METHODSA retrospective review of ACD patients who underwent posterior-based osteotomies for deformity correction from 2010 to 2019 was performed. Inclusion criteria were cervical kyphosis > 20° and/or cervical sagittal vertical axis (cSVA) > 4 cm. Multivariate analysis was used to identify risk factors independently associated with ICU and hospital LOS.RESULTSA total of 107 patients were included. The mean age was 63.5 years, and 61.7% were female. Over half (52.3%) underwent 3-column osteotomies, while 47.7% underwent posterior column osteotomies. There was significant correction of all cervical parameters: cSVA (6.0 vs 3.6 cm, p < 0.001), cervical lordosis (8.2° vs −5.3°, p < 0.001), cervical scoliosis (6.5° vs 2.2°, p < 0.001), and T1-slope (40.2° vs 34.5°, p < 0.001). There were also reciprocal changes to the distal spine: thoracic kyphosis (54.4° vs 46.4°, p < 0.001), lumbar lordosis (49.9° vs 45.8°, p = 0.003), and thoracolumbar scoliosis (13.9° vs 11.1°, p = 0.009). Overall, 4 patients (3.7%) suffered aspiration-related complications, 3 patients (2.8%) experienced dysphagia requiring a feeding tube, and 4 patients (3.7%) had compromised airways, with 1 resulting in death. The mean ICU and hospital LOS were 2.8 days and 7.9 days, respectively. Multivariate analysis identified three factors independently associated with longer ICU LOS: female sex (3.0 vs 2.4 days, p = 0.004), ≥ 12 segments fused (3.5 vs 1.9 days, p = 0.002), and postoperative complication (4.0 vs 1.9 days, p = 0.017). These same factors were independently associated with longer hospital LOS as well: female sex (8.3 vs 7.3 days, p = 0.013), ≥ 12 segments fused (9.4 vs 6.2 days, p = 0.001), and complication (9.7 vs 6.7 days, p = 0.026).CONCLUSIONSPosterior-based osteotomies are very effective for the correction of ACD, but postoperative hospital stays are relatively longer than those following surgery for degenerative disease. Risk factors for prolonged ICU and hospital LOS consist of both nonmodifiable (female sex) and modifiable (≥ 12 segments fused and presence of complication) risk factors. Additional multicenter prospective studies will be needed to validate these findings.

scholarly journals Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis

Endoscopy ◽  
2019 ◽  
Vol 51 (08) ◽  
pp. 722-732 ◽  
Author(s):  
Sally Wai-Yin Luk ◽  
Shayan Irani ◽  
Rajesh Krishnamoorthi ◽  
James Yun Wong Lau ◽  
Enders Kwok Wai Ng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Acute Cholecystitis ◽  
Clinical Success ◽  
Meta Analysis ◽  
Surgical Patients ◽  
Technical Success ◽  
Ultrasound Guided ◽  
Post Procedure ◽  
Hospital Stays

Abstract Background Recent evidence suggests that endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is an effective and safe alternative to percutaneous drainage (PT-GBD). We conducted a systematic review and meta-analysis to compare these two procedures in high risk surgical patients with acute cholecystitis. Methods A comprehensive electronic literature search was conducted for all articles published up to October 2017 to identify comparative studies between EUS-GBD and PT-GBD. A meta-analysis was performed on outcomes including technical success, clinical success, post-procedure adverse events, length of hospital stay, unplanned hospital readmission, need for reintervention, recurrent cholecystitis, and disease- or treatment-related mortality for these two procedures. Results Five comparative studies (206 patients in the EUS-GBD group vs. 289 patients in the PT-GBD group), were included in the final analysis. There were no statistically significant differences in technical success (odds ratio [OR] 0.43, 95 % confidence interval [CI] 0.12 to 1.58; P  = 0.21; I 2 = 0 %) and clinical success (OR 1.07, 95 %CI 0.36 to 3.16; P  = 0.90; I 2 = 44 %) between the two procedures. EUS-GBD had fewer adverse events than PT-GBD (OR 0.43, 95 %CI 0.18 to 1.00; P  = 0.05; I 2 = 66 %). Moreover, patients undergoing EUS-GBD had shorter hospital stays, with pooled standard mean difference of – 2.53 (95 %CI – 4.28 to – 0.78; P = 0.005; I 2 = 98 %), and required significantly fewer reinterventions (OR 0.16, 95 %CI 0.04 to 0.042; P <  0.001; I 2 = 32 %) resulting in significantly fewer unplanned readmissions (OR 0.16, 95 %CI 0.05 to 0.53; P  = 0.003; I 2 = 79 %). Conclusions EUS-GBD was associated with lower rates of post-procedure adverse events, shorter hospital stays, and fewer reinterventions and readmissions compared with PT-GBD in patients with acute cholecystitis who were unfit for surgery.

scholarly journals Managing the Risk of Adverse Events Using the Example of a Hospital in Wroclaw

2014 ◽  
Vol 39 (1) ◽  
pp. 155-166
Author(s):  
Agata Lisiewicz Kaleta ◽  
Aleksandra Sierocka ◽  
Petre Iltchev ◽  
Michał Marczak
Keyword(s):  
Health Care ◽  
Risk Management ◽  
Adverse Events ◽  
Risk Identification ◽  
Treatment Costs ◽  
Research Material ◽  
Black Spots ◽  
Remedial Actions ◽  
Hospital Stays ◽  
Jaw Surgery

Abstract. Health Care Centres are institutions which, because of their specificity and character, are particularly exposed to various kinds of risk. One of the most important and most frequently used methods of risk management is the black spots method. The research material collected for the study comes from one of the hospitals in Wrocław. All hospital stays of the C22 (Face and Jaw Surgery Ward) and H05 (Injury and Orthopaedics Surgery Ward) settlement groups (DRG) were analysed - a total of 178 hospitalisations. The black spots method was used in the study, which consisted of risk identification, the ordering of threats and proposals for remedial actions. Using the black spots method, it was possible to identify adverse events that occurred during the hospitalisation of patients with H05 and C22 DRGs in the Injury and Orthopaedics Surgery Ward and Facial and Jaw Surgery Ward. In both cases, the treatment costs for patients with complications were higher than for the stays without complications.

scholarly journals Apoptotic Cells for Therapeutic Use in Cytokine Storm Associated With Sepsis– A Phase Ib Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Peter Vernon van Heerden ◽  
Avraham Abutbul ◽  
Sigal Sviri ◽  
Eitan Zlotnick ◽  
Ahmad Nama ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Emergency Room ◽  
Organ Dysfunction ◽  
Apoptotic Cells ◽  
Cytokine Storm ◽  
Phase Ib ◽  
Immune Modulator ◽  
Hospital Stays ◽  
Historical Controls

BackgroundSepsis has no proven specific pharmacologic treatment and reported mortality ranges from 30%–45%. The primary aim of this phase IB study was to determine the safety profile of Allocetra™-OTS (early apoptotic cell) infusion in subjects presenting to the emergency room with sepsis. The secondary aims were to measure organ dysfunction, intensive care unit (ICU) and hospital stays, and mortality. Exploratory endpoints included measuring immune modulator agents to elucidate the mechanism of action.MethodsTen patients presenting to the emergency room at the Hadassah Medical Center with sepsis were enrolled in this phase Ib clinical study. Enrolled patients were males and females aged 51–83 years, who had a Sequential Organ Failure Assessment (SOFA) score ≥2 above baseline and were septic due to presumed infection. Allocetra™-OTS was administered as a single dose (day +1) or in two doses of 140×106 cells/kg on (day +1 and +3), following initiation of standard-of-care (SOC) treatment for septic patients. Safety was evaluated by serious adverse events (SAEs) and adverse events (AEs). Organ dysfunction, ICU and hospital stays, and mortality, were compared to historical controls. Immune modulator agents were measured using Luminex® multiplex analysis.ResultsAll 10 patients had mild-to-moderate sepsis with SOFA scores ranging from 2–6 upon entering the study. No SAEs and no related AEs were reported. All 10 study subjects survived, while matched historical controls had a mortality rate of 27%. The study subjects exhibited rapid resolution of organ dysfunction and had significantly shorter ICU stays compared to matched historical controls (p&lt;0.0001). All patients had both elevated pro- and anti-inflammatory cytokines, chemokines, and additional immune modulators that gradually decreased following treatment.ConclusionAdministration of apoptotic cells to patients with mild-to-moderate sepsis was safe and had a significant immuno-modulating effect, leading to early resolution of the cytokine storm.Clinical Trial RegistrationClinicalTrials.gov Identifier: NCT03925857. (https://clinicaltrials.gov/ct2/show/study/NCT03925857).

scholarly journals Efficacy of a topical gelatin-thrombin hemostatic matrix, FLOSEAL®, in intracranial tumor resection

2020 ◽  
Vol 11 ◽  
pp. 16
Author(s):  
Dai Kamamoto ◽  
Tokunori Kanazawa ◽  
Eriko Ishihara ◽  
Kaoru Yanagisawa ◽  
Hideyuki Tomita ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Adverse Events ◽  
Postoperative Bleeding ◽  
Tumor Resection ◽  
Intracranial Tumor ◽  
Hemostatic Agent ◽  
Life Threatening ◽  
Hospital Stays ◽  
Brain Tumor Resection ◽  
Rate Of Success

Background: Hemostasis plays an important role in safe brain tumor resection and also reduces the risk for surgical complications. This study aimed to evaluate the efficacy of FLOSEAL®, a topical hemostatic agent that contains thrombin and gelatin granules, in brain tumor resections. Methods: We evaluated the hemostatic effect of FLOSEAL by scoring the intensity of bleeding from 1 (mild) to 4 (life threatening). We assessed the rate of success of hemostasis with 100 patients who underwent intracranial tumor resection. We also investigated the duration of the operation, the amount of intra- and postoperative bleeding, the number of hospital stays, and adverse events in patients who used FLOSEAL compared with those who did not use FLOSEAL. Results: FLOSEAL was applied to a total of 109 bleeding areas in 100 patients. A total of 95 bleeding areas had a score of 1 and 91 (96%) showed successful hemostasis. Thirteen bleeding areas scored 2 and 8 (62%) showed hemostasis with the first application of FLOSEAL. The second application was attempted with five bleeding areas and four showed hemostasis. About 94% (103/109 areas) of bleeding points successfully achieved hemostasis by FLOSEAL. Moreover, FLOSEAL significantly decreased the amount of intraoperative bleeding and postoperative bleeding as assessed with computed tomography on 1 day postoperatively compared with no use of FLOSEAL. There were no adverse events related to FLOSEAL use. Conclusion: Our results indicate that FLOSEAL is a reliable, convenient, and safe topical hemostatic agent for intracranial tumor resection.

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