Older Blood Is Associated With Increased Mortality and Adverse Events in Massively Transfused Trauma Patients: Secondary Analysis of the PROPPR Trial

ABSTRACTObjectivesWith regionalized trauma care, medical transport times can be prolonged, requiring paramedics to manage patient care and symptoms. Our objective was to evaluate pain management during air transport of trauma patients.MethodsWe conducted a 12-month review of electronic paramedic records from a provincial critical care transport agency. Patients were included if they were ≥18 years old and underwent air transport to a trauma centre, and excluded if they were Glasgow Coma Scale score <14, intubated, or accompanied by a physician or nurse. Demographics, injury description, and transportation parameters were recorded. Outcomes included pain assessment via 11-point numerical rating scale, patterns of analgesia administration, and analgesia-related adverse events. Results were reported as mean ± standard deviation, [range], (percentage).ResultsWe included 372 patients: 47.0 years old; 262 males; 361 blunt injuries. Transport duration was 82.4 ± 46.3 minutes. In 232 (62.4%) patients who received analgesia, baseline numerical rating scale was 5.9 ± 2.5. Fentanyl was most commonly administered at 44.3 [25–60] mcg. Numerical rating scale after first analgesia dose decreased by 1.1 [-2–7]. Thereafter, 171 (73.7%) patients received 2.4 [1-18] additional doses. While 44 (23.4%) patients had no change in numerical rating scale after first analgesia dose, subsequent doses resulted in no change in numerical rating scale in over 65% of patients. There were 43 adverse events recorded, with nausea the most commonly reported (39.5%).ConclusionsInitial and subsequent dose(s) of analgesic had minimal effect on pain as assessed via numerical rating scale, likely due in part to inadequate dosing. Future research is required to determine and address the barriers to proper analgesia.

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Association between off-hour presentation and endotracheal-intubation-related adverse events in trauma patients with a predicted difficult airway: A historical cohort study at a community emergency department in Japan

Scandinavian Journal of Trauma Resuscitation and Emergency Medicine ◽

10.1186/s13049-016-0296-2 ◽

2016 ◽

Vol 24 (1) ◽

Cited By ~ 7

Author(s):

Yuko Ono ◽

Takuya Sugiyama ◽

Yasuyuki Chida ◽

Tetsuya Sato ◽

Hiroaki Kikuchi ◽

...

Keyword(s):

Emergency Department ◽

Cohort Study ◽

Adverse Events ◽

Difficult Airway ◽

Endotracheal Intubation ◽

Trauma Patients ◽

Historical Cohort ◽

Historical Cohort Study

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Predictive factors for reporting adverse events following spinal manipulation in randomized clinical trials – secondary analysis of a systematic review

Musculoskeletal Science and Practice ◽

10.1016/j.msksp.2017.05.002 ◽

2017 ◽

Vol 30 ◽

pp. 34-41 ◽

Cited By ~ 3

Author(s):

Lindsay M. Gorrell ◽

Benjamin Brown ◽

Reidar P. Lystad ◽

Roger M. Engel

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Predictive Factors ◽

Spinal Manipulation ◽

Randomized Clinical Trials ◽

Secondary Analysis

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Development and Testing of a Lymphoma Clinical Trials Specific Frailty Index: A Secondary Analysis of the LY.12 Clinical Trial

Blood ◽

10.1182/blood-2021-153037 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4076-4076

Author(s):

Abi Vijenthira ◽

Xinzhi Li ◽

Michael Crump ◽

Annette E. Hay ◽

Lois E. Shepherd ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Adverse Events ◽

Board Of Directors ◽

Research Funding ◽

Frailty Index ◽

Secondary Analysis ◽

Advisory Committees ◽

Frail Patients ◽

The Impact

Abstract Background: Frailty is common in older patients with lymphoma. However, it remains unknown whether frailty is prevalent in patients included in clinical trials of lymphoma, as those with frailty may meet inclusion criteria of a trial which do not include functional information beyond performance status (PS). Understanding the prevalence and impact of frailty in clinical trials is important to direct future stratification criteria, as well as to have robust data to counsel frail patients on their potential outcomes. Methods: We conducted a secondary analysis using data from the phase III LY.12 clinical trial in which patients with relapsed aggressive non-Hodgkin lymphoma were randomized to gemcitabine-dexamethasone-cisplatin or dexamethasone-high dose cytarabine-cisplatin chemotherapy prior to autologous stem cell transplant. The primary objective of our study was to construct a lymphoma clinical trials specific frailty index (FI) using previously described methods (Searle. BMC Geriatr. 2008;8:24). Secondary objectives were to describe the association of frailty (binary variable) with overall survival (OS), event-free survival (EFS), hospitalization, adverse events (AE), serious adverse events (SAE), and proceeding to transplant, and to describe the association of frailty with these outcomes, controlling for important covariates (age, sex, immunophenotype, revised international prognostic index score (rIPI), Eastern Cooperative Oncology Group (ECOG) PS, stage, and response to previous chemotherapy). Results: 619 patients in the LY12 trial were used to construct the frailty index (Table 1). Using a binary cut-off for frailty (<0.2), 15% (N=93) of patients were classified as frail. There were no differences in age or sex between frail and non-frail patients; however they differed in terms of other lymphoma-related characteristics (Table 2). Frailty was strongly associated with OS (HR 2.012, 95% CI 1.57-2.58), EFS (HR 1.94, 95% CI 1.53-2.46), frequency of the worst overall Grade >3 AE (OR 2.65 (15% vs. 6%), p=0.003), and likelihood of proceeding to ASCT (OR 0.26, 95% CI 0.15-0.43), but not hospitalization (OR 1.52, 95% CI 0.97-2.40) or SAE (6% vs. 4%, p=0.3). In multivariable analysis, frailty was not significantly associated with OS, EFS, likelihood of proceeding to ASCT, nor hospitalization (Table 3), though there was a trend to significance for ASCT. However, rIPI remained significantly associated with OS and EFS, ECOG remained significantly associated with OS (Table 3) Conclusion: A potentially broadly applicable lymphoma clinical trials specific FI was constructed through secondary analysis of LY12 data. 15% of patients were classified as frail. Frailty was significantly associated with OS, EFS, frequency of grade >3 AE and likelihood of proceeding to transplant. However, this relationship no longer was significant when controlling for lymphoma-related prognostic variables, suggesting that the impact of poor prognostic features of lymphoma supersede the impact of frailty alone in this younger clinical trial population. Interestingly, rIPI and ECOG demonstrated their value as simple predictors that are highly associated with OS and/or EFS even when controlling for other important covariates including frailty. These findings require further testing in an external data set, and would be particularly valuable to test in an older population. Calibration of the FI against clinical frailty assessment (e.g. Clinical Frailty Scale, Comprehensive Geriatric Assessment) would also be meaningful to confirm its ability to classify frail versus non-frail patients. Figure 1 Figure 1. Disclosures Crump: Epizyme: Research Funding; Roche: Research Funding; Kyte/Gilead: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Hay: Merck: Research Funding; Roche: Research Funding; Abbvie: Research Funding; Amgen: Research Funding; Karyopharm: Research Funding; Seattle Genetics: Research Funding. Prica: Astra-Zeneca: Honoraria; Kite Gilead: Honoraria.

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Preliminary Estimates of Change in Physical Function After Targeted Kyphosis Exercise Intervention in Older Adults With Low Function: A Secondary Analysis of The SCOR Trial

10.21203/rs.3.rs-111481/v1 ◽

2020 ◽

Author(s):

Amy Gladin ◽

Wendy Katzman ◽

Yoshimi Fukuoka ◽

Neeta Parimi ◽

Shirley Wong ◽

...

Keyword(s):

Older Adults ◽

Adverse Events ◽

Physical Function ◽

High Intensity ◽

Exercise Intervention ◽

Secondary Analysis ◽

Community Dwelling ◽

Spinal Curvature ◽

Targeted Interventions ◽

Function Group

Abstract Background: Hyperkyphosis is common in older adults and associated with low physical function and reduced health related quality of life (HrQol). Improved kyphosis has been previously established in kyphosis-targeted interventions in randomized controlled trials in older adults with hyperkyphosis however evidence for improved physical function is conflicting. Few studies have investigated change in physical function after a targeted kyphosis intervention in older adults with low physical function. The primary aim in this descriptive study was to explore change in physical function after a progressive high intensity 3-month targeted kyphosis exercise and posture training intervention in older adults with low physical function and hyperkyphosis. Secondary aims were to explore change in HrQol, spinal strength and spinal curvature, and adherence and safety of the intervention in older adults with low physical function and hyperkyphosis.Methods: In this secondary analysis of the Specialized Center of Research (SCOR) Kyphosis randomized trial, 101 community dwelling older men and women with hyperkyphosis who completed the intervention were divided into a low function group (LFG) and high function group (HFG). Baseline characteristics were compared between LFG and HFG. Physical function, HrQol, spinal strength and spinal curvature (kyphosis and lordosis) pre/post intervention change scores were explored within and between groups. Adherence and adverse events were examined in the LFG and HFG. Results:Twenty-six (26%) older adults were LFG, mean SPPB 9.62 (SD=1.17) points. At baseline, the LFG was older than HFG (p=0.005), endorsed more pain, (p=0.060), had worse physical function and HrQol (p≤0.001), and comparable kyphosis (p=0.640). SPPB increased 0.62 (95% CI: -0.20 to 1.44) points in the LFG and decreased 0.04 (95%CI: -0.28 to 0.19) points in the HFG, p=0.020. Gait speed improved 0.04 (95%CI: -0.02 to 0.10) m/s in the LFG. Kyphosis improved equally in both groups. Adherence was similar and there were no adverse events in the LFG or HFG. Conclusions:Older adults with low physical function and hyperkyphosis may improve physical function after a kyphosis targeted intervention. Older adults with low physical function may safely participate in targeted high-intensity kyphosis exercise and posture training. This observation needs to be confirmed in larger adequately powered studies. Clinicaltrials.gov dentifier: NCT01766674

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Venous thromboembolism in children undergoing surgery: incidence, risk factors and related adverse events

World Journal of Pediatric Surgery ◽

10.1136/wjps-2019-000084 ◽

2020 ◽

Vol 3 (1) ◽

pp. e000084

Author(s):

Elbert Johann Mets ◽

Ryan Patrick McLynn ◽

Jonathan Newman Grauer

Keyword(s):

Risk Factors ◽

Venous Thromboembolism ◽

Adverse Events ◽

General Surgery ◽

Elective Surgery ◽

Cohort Analysis ◽

Adverse Outcomes ◽

Trauma Patients ◽

Improvement Project ◽

Increased Risk

BackgroundAlthough less common in adults, venous thromboembolism (VTE) in children is a highly morbid, preventable adverse event. While VTE has been well studied among pediatric hospitalized and trauma patients, limited work has been done to examine postoperative VTE in children undergoing surgery.MethodsUsing data from National Surgical Quality Improvement Project Pediatric database (NSQIP-P) from 2012 to 2016, a retrospective cohort analysis was performed to determine the incidence of, and risk factors for, VTE in children undergoing surgery. Additionally, the relationships between VTE and other postoperative adverse outcomes were evaluated.ResultsOf 361 384 pediatric surgical patients, 378 (0.10%) were identified as experiencing postoperative VTE. After controlling for patient and surgical factors, we found that American Society of Anesthesiologists (ASA) class of II or greater, aged 16–18 years, non-elective surgery, general surgery (compared with several other surgical specialties), cardiothoracic surgery (compared with general surgery) and longer operative time were significantly associated with VTE in pediatric patients (p<0.001 for each comparison). Furthermore, a majority of adverse events were found to be associated with increased risk of subsequent VTE (p<0.001).ConclusionIn a large pediatric surgical population, an incidence of postoperative VTE of 0.10% was observed. Defined patient and surgical factors, and perioperative adverse events were found to be associated with such VTE events.

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Trauma Computed Tomography in the Modern Era: Not Always Quick and Safe

The American Surgeon ◽

10.1177/00031348211061330 ◽

2021 ◽

pp. 000313482110613

Author(s):

Cameron Ghafil ◽

Kazuhide Matsushima ◽

Hiroto Chiba ◽

Renqing Wu ◽

Heeseop Shin ◽

...

Keyword(s):

Computed Tomography ◽

Adverse Events ◽

Ct Scanning ◽

Trauma Team ◽

Whole Body ◽

Trauma Patients ◽

Diagnostic Modality ◽

Scanning Process ◽

Whole Body Ct ◽

Trauma Ct

Background Computed tomography (CT) has emerged as the diagnostic modality of choice in trauma patients. Recent studies suggest its use in hemodynamically unstable patients is safe and potentially lifesaving; however, the incidence of adverse events (AE) during the trauma CT scanning process remains unknown. Study Design Over a 6-month period at a Level 1 trauma center, data on patients undergoing trauma CT (whole-body CT (WBCT) +/− additional CT studies) were prospectively collected. All patients requiring a trauma team activation (TTA) were included. Adverse events and specific time intervals were recorded from the time of TTA notification to the time of return to the resuscitation bay from the CT suite. Results Of the 94 consecutive patients included in the study, 47.9% experienced 1 or more AE. Median duration away from the resuscitation bay for all patients was 24 minutes. Patients with AE spent a significantly longer time away from the resuscitation bay and had longer scan times. Vasopressor support and ongoing transfusion requirement at the time of CT scanning were associated with AE. Conclusion Adverse events of varying clinical significance occur frequently in patients undergoing emergent trauma CT. A standard trauma CT protocol could improve the efficiency and safety of the scanning process.

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Impact of strategic planning, organizational culture imprint and care bundles to reduce adverse events in the ICU

International Journal for Quality in Health Care ◽

10.1093/intqhc/mzy198 ◽

2018 ◽

Vol 31 (6) ◽

pp. 480-484

Author(s):

Pablo Álvarez-Maldonado ◽

Arturo Reding-Bernal ◽

Alejandro Hernández-Solís ◽

Raúl Cicero-Sabido

Keyword(s):

Organizational Culture ◽

Strategic Planning ◽

Adverse Events ◽

Usual Care ◽

Care Center ◽

Tertiary Care ◽

Secondary Analysis ◽

Healthcare Personnel ◽

Cross Sectional ◽

Care Bundles

Abstract Objective To evaluate the occurrence of adverse events during a multifaceted program implementation. Design Cross-sectional secondary analysis. Setting The respiratory-ICU of a large tertiary care center. Participants Retrospectively collected data of patients admitted from 1 March 2010 to 28 February 2014 (usual care period) and from 1 March 2014 to 1 March 2017 (multifaceted program period) were used. Interventions The program integrated three components: (1) strategic planning and organizational culture imprint; (2) training and practice and (3) implementation of care bundles. Strategic planning redefined the respiratory-ICU Mission and Vision, its SWOT matrix (strengths, weaknesses, opportunities, threats) as well as its medium to long-term aims and planned actions. A ‘Wear the Institution's T-shirt’ monthly conference was given in order to foster organizational culture in healthcare personnel. Training was conducted on hand hygiene and projects ‘Pneumonia Zero’ and ‘Bacteremia Zero’. Finally, actions of both projects were implemented. Main outcome measures Rates of adverse events (episodes per 1000 patient/days). Results Out of 1662 patients (usual care, n = 981; multifaceted program, n = 681) there was a statistically significant reduction during the multifaceted program in episodes of accidental extubation ([Rate ratio, 95% CI] 0.31, 0.17–0.55), pneumothorax (0.48, 0.26–0.87), change of endotracheal tube (0.17, 0.07–0.44), atelectasis (0.37, 0.20–0.68) and death in the ICU (0.82, 0.69–0.97). Conclusions A multifaceted program including strategic planning, organizational culture imprint and care protocols was associated with a significant reduction of adverse events in the respiratory-ICU.

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