Therapeutics And Clinical Risk Management[JOURNAL]
Sun
200 papers
Modified Alberta Stroke Program Early CT Score (ASPECTS) of Contrast Extravasation on Dual-Energy CT Predicts Haemorrhagic Transformation and Poor Outcome After Endovascular Thrombectomy.
Chen X, Xu J, Zhang S … +6 more , Guo S, Wang H, Shang Y, Shen P, Ye J, Geng Y
Ther Clin Risk Manag · 2025 · PMID 41355976 · Full text
PURPOSE: Haemorrhagic transformation (HT) is an unpredictable complication of acute ischaemic stroke with large vessel occlusion following endovascular thrombectomy (EVT), and imaging parameters that are correlated with...
PURPOSE: Haemorrhagic transformation (HT) is an unpredictable complication of acute ischaemic stroke with large vessel occlusion following endovascular thrombectomy (EVT), and imaging parameters that are correlated with haemorrhage are unknown. We developed a modified version of the Alberta Stroke Program Early Computed Tomography Score (ASPECTS) by adding a periventricular region to assess cerebral contrast extravasation (CE) on dual-energy computed tomography (DECT) and assessed its predictive value for HT. METHODS: In total, 101 patients who underwent DECT immediately after EVT were prospectively enrolled. CE was defined as incident hyperdensity on iodine overlay maps. We quantified the CT attenuation in Hounsfield units (HU) and iodine concentration within the CE regions. The modified ASPECTS divided the middle cerebral artery vascular territory into 11 regions and added one region (paraventricular) to the original score. CE was scored as 1 point for each region, and the cumulative score was determined. Follow-up imaging was performed within 7 days postoperatively to confirm the occurrence of HT. A receiver operating characteristic (ROC) curve was constructed to assess the predictive value of various DECT-measured parameters for HT. RESULTS: Overall, 75/101 (74.3%) patients exhibited CE following EVT, and 47/101 (46.5%) patients exhibited HT. In the ROC curve analysis, the DECT parameter with the maximal area under the curve (AUC) for HT was the modified ASPECTS (AUC=0.87), indicating that patients with a modified ASPECTS >2 were more likely to develop HT (sensitivity: 83.0%, specificity: 83.3%). The maximum iodine concentration (AUC=0.76) and maximum CT attenuation (AUC=0.68) in the hyperdense region were also predictors of postoperative HT. CONCLUSION: The modified ASPECTS is a practical and sensitive method for assessing postoperative HT risk in patients following EVT.
CHADS-VASc Score Predicts Prognosis in Patients with Acute Coronary Syndrome without Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.
Long X, Jin Q, Jiang L … +2 more , Chen R, Hu L
Ther Clin Risk Manag · 2025 · PMID 41323409 · Full text
PURPOSE: To evaluate the prognostic value of the CHADS-VASc score for 12-month major adverse cardiovascular events (MACE) in Chinese patients with acute coronary syndrome (ACS) without atrial fibrillation (AF) undergoing...
PURPOSE: To evaluate the prognostic value of the CHADS-VASc score for 12-month major adverse cardiovascular events (MACE) in Chinese patients with acute coronary syndrome (ACS) without atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). PATIENTS AND METHODS: This retrospective study included 992 consecutive ACS patients without AF who underwent PCI from January 2019 to December 2022. Patients were stratified into low- (0-1), moderate- (2), and high-risk (>2) groups based on the CHADS-VASc score. The primary endpoint was MACE, defined as a composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke. Multivariate Cox regression was used to evaluate the association between risk groups and outcomes. RESULTS: During the 12-month follow-up, MACE occurred in 12.7%, 21.4%, and 28.8% of the low-, moderate-, and high-risk groups, respectively (<0.01). After adjusting for confounders, the CHADS-VASc score remained independently associated with MACE (HR=2.27, 95% CI: 1.34-3.86 for moderate risk; HR=3.83, 95% CI: 1.90-7.69 for high risk; both <0.01). CONCLUSION: The CHADS-VASc score independently predicts 12-month MACE in non-AF ACS patients after PCI, with risks 2.27-fold higher in moderate-risk and 3.83-fold higher in high-risk patients compared with low-risk patients. This simple, readily available tool may help identify patients at higher risk for MACE and inform secondary prevention strategies.
Methodological Confounding from Neuromuscular Reversal and Unreported PACU Data in Intranasal Dexmedetomidine for Extubation [Letter].
Hwang HS, Hsu HW, Hung MH
Ther Clin Risk Manag · 2025 · PMID 41293650 · Full text
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A Review Vancomycin Role in Gram Positive Biofilm-Associated Infections: Challenges and Emerging Solutions.
Alharbi OS, Alhazmi KA, Gazzaz M … +21 more , Almuhayya S, Aldehalan FA, Sharif AT, Redwan B, Alzain MA, Alhazmi W, Altarawneh H, Hasan Alfreahat HA, Bani Abdel-Rahman S, Halabi WS, Altalhi R, Saleh BH, Alhussainy NH, Alsaedi A, Niyazi HA, Niyazi HA, Juma NA, Zubair MA, Alqarni M, Helmi N, Ibrahem K
Ther Clin Risk Manag · 2025 · PMID 41262223 · Full text
Biofilm-associated infections pose a significant challenge in clinical settings due to their increased resistance to antibiotics and evasion of host immune responses. These infections are responsible for a large proporti...
Biofilm-associated infections pose a significant challenge in clinical settings due to their increased resistance to antibiotics and evasion of host immune responses. These infections are responsible for a large proportion of chronic and recurrent infections, leading to prolonged hospital stays, increased healthcare costs, and elevated morbidity and mortality rates. Vancomycin, a glycopeptide antibiotic, has long been a cornerstone in the treatment of infections caused by Gram-positive bacteria, particularly methicillin-resistant (MRSA). In addition, vancomycin-resistant Enterococcus (VRE) represents an important group of biofilm-forming pathogens, further complicating treatment strategies. However, its efficacy against biofilms remains a subject of ongoing research and debate. The ability of vancomycin to target biofilm-embedded bacteria is often hindered by multiple resistance mechanisms, including poor antibiotic penetration, metabolic adaptation of biofilm-associated cells, and the presence of persister cells. The aim of this review is to evaluate vancomycin's antibiofilm activity by examining its mechanism of action, pharmacokinetics, effectiveness, limitations, and potential strategies to enhance its therapeutic outcomes. Several novel approaches have been explored to augment vancomycin's antibiofilm activity, including combination therapies, adjuvant strategies, and nanotechnology-based drug delivery systems. Understanding these factors is crucial for optimizing therapeutic strategies and overcoming the persistent challenge of biofilm-related infections. This review synthesizes current evidence and highlights areas requiring further research to enhance vancomycin's efficacy against biofilm-associated infections.
Supine Positioning in Primary Total Hip Replacement is Associated with a Shorter Hospital Stay Than Lateral Positioning: A Retrospective Propensity-Score Matched Cohort Study.
Tsai YF, Hsu CY, Hsu WT … +4 more , Lai CW, Lee TY, Huang TW, Wu SC
Ther Clin Risk Manag · 2025 · PMID 41257024 · Full text
BACKGROUND: There is still no definite answer regarding the most advantageous patient positioning during total hip replacement (THR). We compared whether patient position (lateral vs supine) incur a difference on hospita...
BACKGROUND: There is still no definite answer regarding the most advantageous patient positioning during total hip replacement (THR). We compared whether patient position (lateral vs supine) incur a difference on hospital length of stay (LOS) after primary THR. METHODS: This retrospective cohort study included primary THR patients at a single tertiary center (2017-2022). THR patients prepared in the lateral decubitus position were compared to those in the supine position. Propensity score matching at a 1:4 ratio was applied to minimize selection bias. Matching covariates included age, sex, body weight, comorbidities (hypertension, diabetes), anesthesia time, and intraoperative tranexamic acid use. After matching, 990 patients were analyzed (792 lateral; 198 supine). RESULTS: In supine group, the median LOS (5 days, IQR: 4-6) was shorter than the lateral group (5 days, IQR: 5-6; <0.001). More supine patients were discharged before day 5 (45.5% vs 22.7%, <0.001). Multivariate analysis revealed supine position as the strongest protective factor against long hospitalization (OR: 0.32, 95% CI: 0.23-0.46, <0.001). Other notable predictors of long LOS included ASA ≥III (OR: 1.74), longer anaesthesia duration (OR: 1.78), and higher IV fluid administration (OR: 1.08). Patient positioning did not notably predict blood transfusion risk (OR: 1.32, =0.144). CONCLUSION: THR patients in supine positioning have a substantial reduction in hospital LOS compared to patients in lateral decubitus positioning, with supine position providing a 68% reduction in risk of long hospitalization. The two groups showed no difference in blood transfusion requirements.
A Stratified Surgical Approach for Convergence Insufficiency-Type Exotropia Based on Near Deviation Magnitude: A Retrospective Cohort Study of Motor and Sensory Outcomes.
Dong F, Liu P, Wang Y
Ther Clin Risk Manag · 2025 · PMID 41229394 · Full text
OBJECTIVE: To evaluate the efficacy and safety of a stratified surgical strategy for convergence insufficiency-type exotropia (CIX(T)) tailored to the magnitude of near deviation, with a primary outcome of postoperative...
OBJECTIVE: To evaluate the efficacy and safety of a stratified surgical strategy for convergence insufficiency-type exotropia (CIX(T)) tailored to the magnitude of near deviation, with a primary outcome of postoperative motor success (orthophoria) and a secondary outcome of stereopsis improvement. METHODS: This retrospective cohort study included 85 CIX(T) patients (near deviation ≥ distance deviation by 15Δ) treated between July 2015 and June 2022. Patients were stratified into three groups based on near deviation magnitude. Group 1 (n=15, <30Δ) underwent unilateral medial rectus resection; Group 2 (n=38, 30-80Δ) received unilateral lateral rectus recession combined with medial rectus resection; Group 3 (n=32, 85-130Δ) underwent bilateral lateral rectus recession plus unilateral medial rectus resection. Ocular alignment (prism cover test) and stereopsis (Titmus test) were assessed preoperatively, at 1 week (short-term), and 3 months (intermediate-term) postoperatively. RESULTS: Baseline characteristics were comparable across groups, except for the stratification variable of near deviation. At the 3-month follow-up, motor success was achieved in 20.0% of Group 1, 89.5% of Group 2, and 87.5% of Group 3. Group 1 showed a high rate of undercorrection (80.0%), whereas Groups 2 and 3 demonstrated stable alignment with minimal undercorrection (10.5% and 9.4%, respectively). Stereopsis scores significantly improved from preoperative levels in Group 2 (P<0.001) and Group 3 (P<0.001), but regressed in Group 1 (P>0.05). A planned slight initial overcorrection (10-15Δ) at distance was significantly correlated with better intermediate-term alignment (r = 0.68, 95% CI: 0.51 to 0.80, P<0.001). CONCLUSION: These findings support a stratified surgical approach for CIX(T) based on near deviation magnitude. While combined recession-resection procedures are effective for moderate-to-large angle deviations, unilateral medial rectus resection for small-angle CIX(T) resulted in high rates of undercorrection. This suggests that the surgical plan for small-angle CIX(T) may require more aggressive dosages or alternative strategies.
Impact of Oncology Nursing Interventions on Chemotherapy-Induced Toxicities in Lung Cancer Patients.
Gao Y, Guo M
Ther Clin Risk Manag · 2025 · PMID 41221162 · Full text
BACKGROUND: Chemotherapy-induced toxicities are a significant challenge in lung cancer treatment, leading to reduced treatment adherence, increased hospital readmissions, and lower quality of life. Oncology nursing plays...
BACKGROUND: Chemotherapy-induced toxicities are a significant challenge in lung cancer treatment, leading to reduced treatment adherence, increased hospital readmissions, and lower quality of life. Oncology nursing plays a vital role in managing these toxicities through early assessment, patient education, and supportive care. This study aimed to evaluate the impact of a structured oncology nursing intervention on the management of chemotherapy-related toxicities in lung cancer patients. METHODS: This retrospective cohort study analyzed 313 patients with pathologically confirmed lung cancer who received first-line chemotherapy at Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, between January 2021 and December 2023. Patients were divided into two groups: the intervention group (n = 148) received comprehensive oncology nursing services, including toxicity education, symptom monitoring via telephone follow-up, early triage of adverse events, and individualized supportive care plans; the control group (n = 165) received standard care. Primary outcomes included the incidence and severity of grade ≥2 chemotherapy toxicities, unscheduled hospital visits, and treatment delays. Secondary outcomes included patient satisfaction and anxiety levels. RESULTS: The intervention group showed a significantly lower incidence of grade ≥2 neutropenia (18.2% vs 30.3%, P = 0.012), chemotherapy-induced nausea/vomiting (24.3% vs 39.4%, P = 0.006), and unplanned emergency visits (9.5% vs 19.4%, P = 0.018). Treatment delays due to unmanaged toxicity were also reduced (12.8% vs 23.0%, P = 0.021). Additionally, the intervention group reported lower anxiety scores (mean STAI: 34.7 vs 41.3, P < 0.001) and higher satisfaction (8.7 vs 7.4, P < 0.001). CONCLUSION: Structured oncology nursing interventions significantly improve the management of chemotherapy-induced toxicities in lung cancer patients, reducing complications, enhancing treatment continuity, and improving psychological well-being.
Reconciling Methodological Paradigms Toward More Accurate Evaluation of Personalized Traditional Chinese Medicine (TCM) Intervention in Standardized Trials: Introducing the TRIPLE-TCM Trial Framework.
Zhao FY, Yue LP, Xu P … +5 more , Conduit R, Zhang WJ, Lee YX, Fu QQ, Chow CM
Ther Clin Risk Manag · 2025 · PMID 41216025 · Full text
Traditional Chinese Medicine (TCM) prioritizes highly individualized diagnosis and treatment, a principle that inherently conflicts with the standardized protocols of explanatory randomized controlled trials (RCTs). Whil...
Traditional Chinese Medicine (TCM) prioritizes highly individualized diagnosis and treatment, a principle that inherently conflicts with the standardized protocols of explanatory randomized controlled trials (RCTs). While pragmatic RCTs have been proposed to better reflect real-world TCM practice, their reliance on unblinded designs raises concerns about placebo effects and potential confounding biases, particularly for interventions like acupuncture. These methodological tensions highlight the need for innovative trial designs that can preserve TCM's personalized ethos while meeting the rigorous standards of evidence-based research. In response, we propose the (TRIPLE-TCM) framework-a hybrid trial design integrating explanatory RCTs, pragmatic RCTs, and partially randomized patient preference trials. TRIPLE-TCM employs a five-step procedure: (1) TCM pattern-guided recruitment to ensure diagnostic homogeneity; (2) hybrid randomization accommodating patient preferences; (3) semi-standardized interventions combining fixed core prescriptions with individualized adjustments; (4) a clinician-patient co-assessment model incorporating TCM-specific outcomes and validated biomarkers; and (5) cost-utility analyses to inform policy. This framework aims to balance internal and external validity while maintaining fidelity to TCM theory and clinical practice, providing a methodological bridge for TCM's broader acceptance. Further studies should validate its feasibility, reproducibility, and cross-cultural generalizability across diverse disease contexts and healthcare settings, advancing evidence-based integration of acupuncture and Chinese herbal medicine into global healthcare systems.
Predictive Value of CT Fractional Flow Reserve and Fat Attenuation Index Derived from Coronary CT Angiography for In-Stent Restenosis After Percutaneous Coronary Intervention.
Li B, Zhang Z, Wei X … +3 more , Song T, Zhao Y, Wang W
Ther Clin Risk Manag · 2025 · PMID 41209661 · Full text
AIM: To investigate the predictive value of CT fractional flow reserve (CT-FFR) and fat attenuation index (FAI) based on Coronary CT Angiography (CCTA) for in-stent restenosis (ISR) in patients with CAD after PCI. METHOD...
AIM: To investigate the predictive value of CT fractional flow reserve (CT-FFR) and fat attenuation index (FAI) based on Coronary CT Angiography (CCTA) for in-stent restenosis (ISR) in patients with CAD after PCI. METHODS: Patients with coronary heart disease who were followed up after coronary stent implantation were retrospectively collected, and clinical data, stent features and imaging characteristics were recorded. The Spearman test was used to analyze the correlation between CT-FFR, FAI and ISR. Univariate and multivariate logistic regression were used to determine the independent influencing factors of ISR, and a nomogram model was constructed. RESULTS: A total of 378 patients were ultimately included. Among them, there were 120 cases in the ISR group and 258 cases in the non-ISR group. Multivariate analysis revealed that CT-FFR, ΔCT-FFR, FAI, stent length, ΔCT-FFR/length, hyperlipidemia, and lipoprotein(a) are independent predictors of ISR. The ROC analysis demonstrated that ΔCT-FFR had the highest predictive accuracy for ISR, with an AUC of 0.923 (95% CI: 0.889-0.957). Several clinical prediction models were developed, among which Model 3 displayed the highest predictive performance (AUC: 0.958, 95% CI, 0.932-0.984). A statistically significant difference was observed between Model 1 and Model 2 (AUC: 0.925 vs 0.950, P < 0.05). However, no significant difference was found between Model 1 and Model 3 (AUC: 0.925 vs 0.928, P > 0.05). CONCLUSION: ΔCT-FFR and peri-stent FAI, as independent predictors of ISR after PCI in patients with coronary heart disease, have a high predictive value for ISR. In addition, the FAI around the stent has incremental value for CT-FFR. It is worth noting that, compared with clinical data, imaging features show higher predictive value.
Association of Serum Cholinesterase with Contrast-Associated Acute Kidney Injury and Adverse Outcomes in Percutaneous Coronary Intervention Patients.
Zhang LW, Zeng JL, Wang CX … +3 more , Luo MQ, Lin KY, Guo Y
Ther Clin Risk Manag · 2025 · PMID 41164328 · Full text
PURPOSE: Serum cholinesterase (SChE) is a pleiotropic biomarker that is closely related to malnutrition, systemic inflammation, and hepatocyte injury. However, the utility of SChE in patients undergoing percutaneous coro...
PURPOSE: Serum cholinesterase (SChE) is a pleiotropic biomarker that is closely related to malnutrition, systemic inflammation, and hepatocyte injury. However, the utility of SChE in patients undergoing percutaneous coronary intervention (PCI) remains unclear. This study sought to investigate the associations between SChE and contrast-associated acute kidney injury (CA-AKI) as well as mortality in patients undergoing PCI. PATIENTS AND METHODS: We retrospectively observed 1,696 patients at a tertiary hospital from January 2016 to December 2018. CA-AKI was defined as an increase in serum creatinine ≥50% or 0.3 mg/dL within 48 h after contrast medium exposure. RESULTS: During hospitalization, 198 patients (11.7%) developed CA-AKI. Restricted cubic spline (RCS) and receiver operating characteristic (ROC) analysis demonstrated that SChE levels were negatively correlated with CA-AKI and had predictive value (AUC, 0.655; 95% CI, 0.613-0.697). Multivariable regression analysis showed that patients in low-SChE group (≤7.5 kU/L) had a higher risk of developing CA-AKI (OR, 1.80; 95% CI, 1.21-2.67) compared to those in the high-SChE group (>7.5 kU/L). Regarding prognosis, SChE levels were also negatively associated with long-term mortality and were capable of predicting 90-day mortality (AUC, 0.826; 95% CI, 0.760-0.892). Patients in the low-SChE group had significantly higher long-term mortality risks (HR, 2.56; 95% CI, 1.55-4.32). Mediation analyses further indicated that CA-AKI partially mediated the relationship between SChE and short-term mortality, with a mediation proportion of 12.79%. CONCLUSION: Low SChE is an independent risk factor for CA-AKI and a poor prognosis after PCI. Short-term mortality associated with SChE levels is partially mediated through the occurrence of CA-AKI. It is recommended that clinicians evaluate SChE levels prior to PCI and adjust hydration therapy according to SChE levels.
Comparison of Neurofactor Changes and Prognosis in Elderly Patients with Spontaneous Intracerebral Hemorrhage Treated with Endoscopic versus Conventional Craniotomy Surgery.
Lei C, Li C, Chen X … +4 more , Zhou G, Zheng X, Zhang Z, Qu X
Ther Clin Risk Manag · 2025 · PMID 41164327 · Full text
OBJECTIVE: To compare the clinical efficacy, neurofactor changes, and prognosis in elderly patients with spontaneous intracerebral hemorrhage (ICH) treated with endoscopic surgery versus conventional craniotomy. METHODS:...
OBJECTIVE: To compare the clinical efficacy, neurofactor changes, and prognosis in elderly patients with spontaneous intracerebral hemorrhage (ICH) treated with endoscopic surgery versus conventional craniotomy. METHODS: A retrospective analysis was conducted on 88 elderly patients with spontaneous ICH admitted from July 2021 to April 2024. Based on surgical method, patients were assigned to either the conventional craniotomy group (n=44) or the endoscopic surgery group (n=44). Surgical efficacy (hematoma evacuation rate, surgical duration, intraoperative blood loss), short-term prognosis (ICU stay, hospital stay, GOS, NIHSS, ADL scores), serum neurofactors (SOD, NSE, NGF, BDNF), inflammatory markers (WBC, CRP, PCT), and complication rates were compared. RESULTS: (1) The endoscopic group had significantly shorter surgical time and lower blood loss than the craniotomy group (P<0.05), with similar hematoma evacuation rates (P>0.05). (2) ICU and hospital stays were significantly shorter in the endoscopic group (P<0.05). Postoperative GOS and ADL scores were higher, and NIHSS scores were lower in the endoscopic group at 3 months (P<0.05). (3) Compared with preoperative levels, both groups showed a decreasing trend in SOD and NSE and an increasing trend in NGF and BDNF after surgery, with the observation group showing more significant and sustained changes over time (P < 0.05). (4) Although postoperative inflammatory markers increased in both groups, the observation group had milder elevations and faster downward trends (P < 0.05). (5) The complication rate was lower in the endoscopic group (6.82% vs 22.73%, P<0.05). CONCLUSION: Compared to conventional craniotomy, endoscopic hematoma evacuation in elderly ICH patients results in milder inflammatory responses, more favorable neurofactor changes, fewer complications, and improved recovery. However, these findings require further validation due to the retrospective design and limited sample size.
The Effect of Induced Hypothermia on Postoperative Outcomes Following Hyperthermic Intraperitoneal Chemotherapy: A Negative Finding.
Yang MC, Lin KL, Chung KC … +3 more , Chou SE, Chien M, Hsu CY
Ther Clin Risk Manag · 2025 · PMID 41146950 · Full text
PURPOSE: The optimal strategy for body temperature management during cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) remains controversial. This study aimed to assess whether intentiona...
PURPOSE: The optimal strategy for body temperature management during cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) remains controversial. This study aimed to assess whether intentionally cooling the core body temperature (CBT) to hypothermia (<35°C) before the HIPEC phase improves postoperative outcomes. PATIENTS AND METHODS: In this retrospective cohort study, we analyzed 73 patients who underwent CRS plus HIPEC, grouped by CBT immediately before HIPEC: CBT ≥ 35°C (n=51) and CBT < 35°C (n=22). Primary outcomes including time to extubation and Clavien-Dindo classification. Secondary outcomes including length of stay (LOS), ICU stay, postoperative acute kidney injury (AKI) and reintubation event. Intraoperative parameters such as hemodynamic status, blood loss, transfusion requirements, and intravenous (IV) fluid amount were also compared. RESULTS: Compared to the normothermia group, patients in the hypothermia group had significantly longer time to extubation (median 11.5 vs 8.0 hours, p = 0.0314), greater blood loss (median 350 vs 150 mL, p = 0.0045), higher leukocyte-poor red blood cells transfusion units (p = 0.0016) and increased total IV fluid amount (p = 0.0049). Delayed extubation, defined as occurring more than 12 hours after surgery, appeared to be independently associated with hypothermia (odds ratio [OR] 6.31, 95% confidence interval [CI] 1.11-35.70, = 0.037) and total IV fluid administration (per 100 mL; OR 1.05, 95% CI 1.00-1.10, = 0.042) in multivariate analysis. CONCLUSION: Actively inducing hypothermia before the HIPEC phase did not demonstrate improved postoperative outcomes and may be associated with delayed extubation, greater blood loss, higher transfusion requirements, and increased IV fluid administration.
Efficacy and Risk Assessment of Lateral Position Endotracheal Intubation Combined with Airway Surface Anesthesia in Gastrointestinal Endoscopic Surgery: A Randomized Controlled Non-Inferiority Study.
Tang L, Huang J, Guo J … +5 more , Zhang M, Chen W, Zhao X, Xia R, Xu W
Ther Clin Risk Manag · 2025 · PMID 41116772 · Full text
PURPOSE: This study aims to evaluate and compare the efficacy and safety of endotracheal intubation in the lateral versus supine position, with both approaches combined with airway surface anesthesia, in patients undergo...
PURPOSE: This study aims to evaluate and compare the efficacy and safety of endotracheal intubation in the lateral versus supine position, with both approaches combined with airway surface anesthesia, in patients undergoing gastrointestinal endoscopic surgery. PATIENTS AND METHODS: A total of 128 patients undergoing gastrointestinal endoscopic surgery under general anesthesia with intubation were randomized into a lateral (L, n=64) or supine (S, n=64) intubation group, both receiving airway surface anesthesia, between January and March 2025. The primary outcome measure was intubation time, while secondary outcomes included changes in intraoperative vital signs, number of intubation attempts, first-pass success rate, positioning time, healthcare worker satisfaction, and postoperative complications. RESULTS: No significant differences were found between the two groups in terms of age, sex, height, weight, BMI, ASA classification, and airway assessment ( > 0.05). Mean intubation times differed slightly between groups (S group: 37.4±7.6s, 95% CI 35.5-39.3; L group: 40.1±8.5s, 95% CI 38.0-42.2). The non-inferiority margin (δ) for this study was 6s, and the upper limit of the L group's confidence interval (42.2s) was below the threshold of 39.3 + 6s. Thus, lateral position intubation was not inferior to supine intubation in terms of intubation time. There were no significant differences between the groups in the number of intubation attempts or first-pass success rate ( > 0.05). However, during positioning, the S group experienced greater hemodynamic fluctuations and a longer positioning time compared to the L group, and these differences were statistically significant ( < 0.05). Neither group showed any dental injuries or hypoxemia, and there were no significant differences in adverse reactions between the groups ( > 0.05). CONCLUSION: Compared with conventional supine intubation, lateral position endotracheal intubation with airway surface anesthesia achieves similar efficacy while providing better hemodynamic stability, faster positioning, and higher provider satisfaction.
Reduced Long-Term Survival After Postoperative Complications in Major Gastrointestinal Surgery.
Gratama DN, Weinberg L, Raykateeraroj N … +10 more , Suh JMA, Zhao J, Hu EP, Ratnasekara V, Freeman T, Liu DS, Joosten A, Muralidharan V, Nikfarjam M, Lee DK
Ther Clin Risk Manag · 2025 · PMID 41103285 · Full text
PURPOSE: We primarily evaluated the relationship between postoperative complications and long-term survival in patients undergoing major gastrointestinal surgery. Secondarily, we investigated the relationship between the...
PURPOSE: We primarily evaluated the relationship between postoperative complications and long-term survival in patients undergoing major gastrointestinal surgery. Secondarily, we investigated the relationship between the severity and the number of complications and long-term survival. While postoperative complications are prevalent after major abdominal surgery and associated with increased mortality, the effect of their severity and accumulation remains insufficiently explored. PATIENTS AND METHODS: 1989 adult patients undergoing major gastrointestinal surgery between July 2010 and April 2022 were retrospectively studied. Complications were classified using the Clavien-Dindo system. Kaplan-Meier analysis assessed long-term survival, Cox proportional hazards regression with time-dependent coefficients evaluated the impact of complications on mortality. RESULTS: Median age was 64 years (IQR 53-74); 41.8% female and 63.0% of patients were diagnosed with malignancy. Elective procedures comprised 73.0% of cases. Complications occurred in 74.6% of patients. Mortality was higher in patients with complications (32.0%, 95% CI 29.7%-34.5%), compared to those without (21.7%, 95% CI 18.3-25.6%; <0.001). Severe complications (Clavien-Dindo Grade ≥III) were associated with a 15.01-fold higher hazard of mortality within 18 months postoperatively (95% CI 6.83-33.0; <0.001). CONCLUSION: Postoperative complications significantly reduce long-term survival following major gastrointestinal surgery. Both their severity and frequency are critical determinants of poorer outcomes, emphasizing the need for effective prevention strategies.
Exploring the Current Tools in Cardiovascular Risk Assessment in the Middle East and the Need for Region-Specific Models - A Scoping Review.
Al-Ezzi GA, Ali AM, Kubas MA … +1 more , Redzuan AM
Ther Clin Risk Manag · 2025 · PMID 41098766 · Full text
BACKGROUND: Cardiovascular diseases (CVDs) are a major contributor to premature mortality, disability, and reduced quality of life globally. Assessing CVD risks is central to primary prevention, prompting the development...
BACKGROUND: Cardiovascular diseases (CVDs) are a major contributor to premature mortality, disability, and reduced quality of life globally. Assessing CVD risks is central to primary prevention, prompting the development of numerous tools to predict CVD risks for the general population. However, it is unclear which tools are recommended in clinical practice in the Middle East region. AIM: This scoping review aims to identify, review, and summarize the available literature on CVD risk assessment tools recommended for the general population in the Middle East region. METHODS: The scoping review synthesized the literature on CVD risk assessment tools recommended for the general population in the Middle East region. It followed PRISMA-ScR guidelines, covering searches in the Web of Science (WOS), Medline, and Scopus databases. English-language articles published between 2015 and 2024 that focused on the primary prevention of CVDs in sixteen Middle Eastern countries were included. RESULTS: Seventeen articles met the inclusion criteria. The studies were distributed over Cyprus (n=1), Iran (n=7), Saudi Arabia (n=4), Qatar (n=1), the United Arab Emirates (n=3), and Egypt (n=1). Various tools are recommended in these countries, including validated Western tools such as ACC/AHA Pooled-Cohort Equations (PCE), Systematic Coronary Risk Evaluation 2 (SCORE 2), World Health Organization charts (WHO/ ISH) for the Eastern Mediterranean region (EMR), Cardiovascular Disease Risk Algorithm (QRISK3), and PREDICT. Some studies in Iran, Saudi Arabia, the United Arab Emirates, and Egypt focused on developing new CVD risk tools tailored for national use. CONCLUSION: Current studies on CVD risk assessment are limited and have been conducted in six Middle Eastern countries. These studies recommend various tools, including both validated Western models and locally developed frameworks. However, the limitations of existing tools and the gaps in current research underscore the need for further studies to develop or recalibrate models that account for country-specific CVD risk factors across the region.
The Incidence and Risk Factors for Dental Injury in Patients Undergoing General Anesthesia: A Case-Control Study.
Chanthawong S, Nonphiaraj S, Vongtongchith L … +5 more , Tisangka N, Kaewaun J, Sangsungnern P, Ruenhunsa T, Chairatana L
Ther Clin Risk Manag · 2025 · PMID 41090113 · Full text
PURPOSE: Dental injury is a known complication of endotracheal intubation during general anesthesia (GA), yet data on its incidence and associated risk factors remain limited. This study aimed to evaluate the incidence,...
PURPOSE: Dental injury is a known complication of endotracheal intubation during general anesthesia (GA), yet data on its incidence and associated risk factors remain limited. This study aimed to evaluate the incidence, risk factors, and outcomes of dental injury in patients undergoing GA. PATIENTS AND METHODS: This retrospective case-control study was conducted between January 2021 and June 2024. A total of 42,826 patients underwent GA during the study period; 72 cases of dental injury were identified from the departmental database. Controls were time-matched patients who underwent surgery in the same anatomical region, using a case-to-control ratio of 1:4. Univariable and multivariable logistic regression analyses were performed to identify independent risk factors for dental injury. RESULTS: The incidence of dental injury was 0.17%. Univariate analysis identified the following factors as associated with dental injury: age ≥ 60 years, pre-existing dental pathology, Mallampati classification ≥ 3, anticipated difficult intubation, and difficult airway. In the multivariable logistic regression analysis, pre-existing dental pathology (adjusted OR 3.87, 95% CI: 1.92-7.81, p < 0.001), anticipated difficult intubation (adjusted OR 4.99, 95% CI: 1.84-13.50, p = 0.002), and difficult intubation (laryngoscopic view grade ≥ 3) (adjusted OR 10.56, 95% CI: 4.24-26.29, p < 0.001) remained significant independent predictors of dental injury during GA. The most common complication was bleeding. CONCLUSION: Dental injury during GA is uncommon, with an incidence of 0.17%. Pre-existing dental pathology, anticipated difficult intubation, and poor laryngoscopic view (grade ≥ 3) were identified as independent risk factors. Awareness and thorough preoperative assessment of these factors may help reduce the risk of dental injury and related complications.
The Effect of Dexmedetomidine Nasal Spray on Extubation-Related Stress Response and Delayed Extubation After Laparoscopic Surgery: A Randomized Controlled Trial.
Liu Y, Wang X, Dang J … +3 more , Wang Q, Xia Q, Wang Z
Ther Clin Risk Manag · 2025 · PMID 41080218 · Full text
PURPOSE: Smooth removal of the tracheal tube post-laparoscopic surgery is crucial. Dexmedetomidine suppresses airway reflexes and mitigates stress responses. This study sought to assess the effect of dexmedetomidine nasa...
PURPOSE: Smooth removal of the tracheal tube post-laparoscopic surgery is crucial. Dexmedetomidine suppresses airway reflexes and mitigates stress responses. This study sought to assess the effect of dexmedetomidine nasal spray on extubation-related stress response and delayed extubation after laparoscopic surgery. PATIENTS AND METHODS: This study involved 124 patients scheduled for laparoscopic surgery, who were randomly allocated to one of two groups: the dexmedetomidine nasal spray group (Group D, n=62) and the control group (Group C, n=62). 30 min before the end of the surgery, Group D was administered 100 μg of the dexmedetomidine nasal spray, while Group C was given an equivalent volume of normal saline nasal spray. Extubation events and extubation time were documented. Hemodynamic data, Ramsay sedation scale (RSS), NRS scores, postoperative nausea and vomiting (PONV), and total recovery time were evaluated during medication administration and the subsequent postoperative recovery period. RESULTS: The rate of smooth tracheal extubation was significantly higher in Group D than in Group C (93.5% vs 64.5%, < 0.001). Extubation time was markedly reduced in Group D compared to Group C ( = 0.045). Hemodynamic characteristics were comparable across the two groups, but MAP was higher in Group C at 1 and 10 min after extubation ( < 0.05), and HR was higher at 1 and 3 min after extubation ( < 0.05). More favorable sedation was achieved in Group D at 30 min postoperatively ( = 0.025). No significant changes were observed in postoperative PO and PCO, NRS pain score, and the incidence of PONV between the groups. CONCLUSION: Dexmedetomidine nasal spray safely and effectively ameliorated extubation-related stress response following laparoscopic surgery, resulting in smoother extubation. Furthermore, it facilitated the maintenance of hemodynamic stability, shortened extubation time, and provided better postoperative sedation.
Analysis of Modification Zones in Mandibular Complete Denture Models Designed with the Bio-Functional Prosthetic System.
Yan L, Liu Y, Yan YY … +5 more , Li W, Li HW, Wang YL, Zhang ZF, Li XL
Ther Clin Risk Manag · 2025 · PMID 41050345 · Full text
OBJECTIVE: This study aimed to analyze the regions and extent of modifications made to the final mandibular complete denture model designed using the bio-functional prosthetic system (BPS), compared to the initial model,...
OBJECTIVE: This study aimed to analyze the regions and extent of modifications made to the final mandibular complete denture model designed using the bio-functional prosthetic system (BPS), compared to the initial model, utilizing digital scanning technology. METHODS: Twenty individuals with edentulism requiring mandibular restoration using BPS were included in the study. Digital scans of the initial and final gypsum models of the edentulous mandible were obtained. The models were aligned, registered, and analyzed for modification zones using Geomagic Warp software. RESULTS: Statistically significant differences were observed in three specific regions: the posterior fossa of the mylohyoid, the submandibular gland region, and the labial vestibule ( < 0.05). In contrast, differences in the posterior molar pad area were minimal ( > 0.05). Overall, the final model exhibited significant deviations from the initial model ( < 0.05), with the greatest variation observed in the posterior fossa of the mylohyoid and the least variation in the posterior molar pad area. CONCLUSION: The final mandibular complete denture model, constructed using BPS, demonstrates improved accuracy in representing mucosal movement, shape, and positioning under occlusal pressure compared to the initial model. The posterior fossa of the mylohyoid, submandibular gland region, and labial vestibule exhibited enhanced delineation of mucosal movement boundaries, contributing to a more precise functional representation.
Incidence of Complications in High-Risk Patients Undergoing Combined Esophagogastroduodenoscopy and Colonoscopy with Total Intravenous Anesthesia: A Prospective Cohort Study.
Supan W, Ongiem A, Noitasaeng P … +4 more , Bunnag P, Kaosombatwattana U, Supapueng O, Vichitvejpaisal P
Ther Clin Risk Manag · 2025 · PMID 41040918 · Full text
OBJECTIVE: To evaluate the incidence, characteristics, and risk factors of complications related to anesthesia complication in ASA Class III patients undergoing combined esophagogastroduodenoscopy (EGD) and colonoscopy u...
OBJECTIVE: To evaluate the incidence, characteristics, and risk factors of complications related to anesthesia complication in ASA Class III patients undergoing combined esophagogastroduodenoscopy (EGD) and colonoscopy under total intravenous anesthesia (TIVA). MATERIALS AND METHODS: This prospective cohort study was conducted from April 1, 2024, to February 11, 2025. Data collected included baseline characteristics (age, sex, comorbidities, functional capacity, nutritional status, smoking, fasting and medications) and intraoperative/postoperative parameters (anesthetic technique, sedative dosing, IV fluids, complications, and 24-hour status). Descriptive statistics, univariate analysis, and binary logistic regression were applied. RESULTS: Of 403 ASA Class III patients enrolled, 393 were analyzed after excluding 10 for inadequate bowel prep or early termination due to malignancy. A total of 207 patients (52.7%) experienced at least one complication. Common complications included transient hypotension (40.2%), desaturation (15.8%), and airway obstruction (15.5%). Less frequent events were bradycardia (4.1%), hypoxia (1.8%), hypertension (1.8%), tachycardia (0.3%) and respiratory depression (0.5%). Five independent risk factors were significantly associated with complications: preexisting cardiovascular disease - odds ratio (OR=1.678), respiratory disease (OR=1.877), functional capacity < 4 metabolic equivalents (METs), (OR=1.851), nutritional screening score ≥1 (OR =1.518), and single - dose bowel prep regimen (OR=1.614). Complications were more common in women, patients aged 65 years or older, and inpatients, although the difference in hospitalization and outpatient was not statistically significant. Patients with complications received lower total doses of propofol and fentanyl per weight per hour. Dexmedetomidine use was significantly associated with complications among inpatients (p = 0.015). The duration of the procedure was longer in patients with complications (p = 0.002). CONCLUSION: Anesthesia-related complications were frequent among ASA Class III patients who underwent combined EGD and colonoscopy under TIVA, particularly cardiovascular and respiratory events. Identification of five preprocedural risk factors supports the need for improved risk stratification and individualized sedation planning to optimize safety in this high-risk group.
Transplant Without Borders: Clinical Outcomes and Challenges in Transborder Living Donor Pediatric Liver Transplantation in Jordan.
Khdair Ahmad F, Abu Nasrieh D, Rwalah MM … +5 more , Ghanma A, Rayyan Y, Hamad Y, Ahmad T, Mohammad S
Ther Clin Risk Manag · 2025 · PMID 41020283 · Full text
PURPOSE: To describe the clinical outcomes, complications, and logistical challenges of pediatric living donor liver transplantation (LT) in Jordanian children referred abroad, in the absence of a national transplant pro...
PURPOSE: To describe the clinical outcomes, complications, and logistical challenges of pediatric living donor liver transplantation (LT) in Jordanian children referred abroad, in the absence of a national transplant program. PATIENTS AND METHODS: This retrospective study reviewed all pediatric cases referred to the Jordanian Center for Organ Transplantation (JCOT) for LT between 2019 and 2023. Data were collected from JCOT records and follow-up interviews with caregivers. Variables included patient demographics, indications for transplantation, donor-recipient relationships, post-operative complications, survival outcomes, and financial aspects. RESULTS: A total of 31 children were referred for LT, of whom 20 (64.5%) successfully underwent living donor liver transplantation abroad-primarily in Turkey-while 11 (35.5%) remained on the waiting list. Biliary atresia (25%) was the most common indication, followed by Alagille syndrome and progressive familial intrahepatic cholestasis (each 20%). Primary hyperoxaluria, Crigler-Najjar syndrome, and maple syrup urine disease were also observed. Parents were the most frequent donors (70%). The most common complications were bile duct leakage (35%), portal vein thrombosis (20%), and infections (15%). The 5-year post-transplant survival rate was 90%. Among the waiting list group, four children (36.4%) died before receiving a transplant. No children underwent transplantation for pediatric acute liver failure during the study period. The average cost per transplant covered by the Ministry of Health was $61,071, excluding out-of-pocket expenses borne by families. CONCLUSION: This study highlights the feasibility and challenges of transborder pediatric liver transplantation in Jordan. While clinical outcomes for transplanted children were favorable, significant barriers remain, including delayed referrals, financial strain, and mortality among waitlisted patients. These findings underscore the urgent need to establish a national pediatric liver transplant program to improve timely access and long-term care for children with end-stage liver disease in Jordan.
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