Therapeutics And Clinical Risk Management[JOURNAL]
Sun
200 papers
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange versus Oropharyngeal Airway-Assisted Face-Mask Ventilation for Gastric Insufflation During Induction of General Anesthesia in Patients at High Risk for Obstructive Sleep Apnea.
Jia Z, Xu Y, Zhang C … +5 more , Jiang H, Han Y, Yuan X, Wang H, Xie K
Ther Clin Risk Manag · 2026 · PMID 42382179 · Full text
PURPOSE: Obstructive sleep apnea (OSA) is an independent risk factor for gastric insufflation during the induction of general anesthesia. We aimed to compare the impact of oropharyngeal airway-assisted face-mask ventilat...
PURPOSE: Obstructive sleep apnea (OSA) is an independent risk factor for gastric insufflation during the induction of general anesthesia. We aimed to compare the impact of oropharyngeal airway-assisted face-mask ventilation and transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) on gastric insufflation in patients with high-risk OSA. PATIENTS AND METHODS: Patients at high risk for OSA scheduled for elective major abdominal surgery under general anesthesia were randomized 1:1 to either Group T (THRIVE throughout induction) or Group M (face-mask preoxygenation followed by oropharyngeal airway-assisted pressure-controlled ventilation). Gastric antrum ultrasonography was performed at baseline (T), after preoxygenation (T), and post-intubation (T) to assess changes of antral cross-sectional area (CSAa). Arterial blood gases were analyzed at T, T, after induction during ventilation/apnea (T), and T. Adverse events and patient comfort were recorded. The primary outcome was the incidence of gastric insufflation at T. Secondary outcomes included CSAa percentage change, oxygenation and arterial blood gas variables, adverse events, and patient comfort. RESULTS: Of 100 randomized patients, 94 completed the study (47 per group). Group T demonstrated a significantly lower incidence of gastric insufflation post-intubation compared to Group M (23.4% vs 44.7%; = 0.030) and a smaller median percentage increase in antral cross-sectional area (7.62% vs 13.24%; = 0.070). THRIVE provided superior preoxygenation (higher PaO at T, < 0.001). During apnea (T-T), Group T maintained adequate oxygenation (SpO >92%) without mechanical ventilation but developed mild hypercapnia, which was expected to improve following continued mechanical ventilation after intubation. Adverse event rates were non-significant ( = 1.000). Patient comfort scores were significantly higher in Group T ( < 0.001). CONCLUSION: In patients at high risk for OSA, THRIVE reduces the incidence of gastric insufflation during induction compared with oropharyngeal airway-assisted face-mask ventilation. THRIVE improves preoxygenation and patient comfort. Oxygenation was maintained during apnea, with a transient increase in PaCO observed after intubation.
Blood-Based Inflammatory and Metabolic Biomarkers for Assessing Symptom Burden and Quality of Life in Older Adults with Cancer: A Narrative Review.
Lu L, Zhang Y
Ther Clin Risk Manag · 2026 · PMID 42339016 · Full text
BACKGROUND: To evaluate the clinical utility of blood-based inflammatory and metabolic biomarkers in assessing symptom burden and quality of life among older adults with cancer. METHODS: This review synthesizes current e...
BACKGROUND: To evaluate the clinical utility of blood-based inflammatory and metabolic biomarkers in assessing symptom burden and quality of life among older adults with cancer. METHODS: This review synthesizes current evidence regarding the clinical utility and underlying pathophysiological mechanisms of blood-based biomarkers, focusing particularly on the neutrophil-to-lymphocyte ratio (NLR), systemic immune-inflammation index (SII), and modified Glasgow prognostic score (mGPS). RESULTS: Elevated inflammatory markers, such as NLR and SII, independently correlate with increased frailty and functional decline. Concurrently, nutritional-metabolic markers, including hypoalbuminemia and a high mGPS, are strongly associated with anorexia and cancer cachexia. These composite indicators effectively capture the synergistic effects of "inflammaging", neuroinflammation, and tumor-driven metabolic reprogramming. CONCLUSION: Objective, cost-effective, and dynamically measurable inflammatory and metabolic biomarkers represent promising adjunctive tools for early symptom screening. The integration of these markers into comprehensive geriatric assessments may enhance risk stratification and symptom management. However, current evidence is constrained by study heterogeneity, retrospective designs, a lack of standardized cutoffs, and insufficient prospective validation in older cancer populations. Therefore, these biomarkers should be regarded as complementary to traditional assessments rather than definitive standalone tools.
The Future of Interventional Keratoconus Management: Perspectives on Integrating Epithelium-on Oxygen-Enriched Cross-Linking into Comprehensive Care Pathways.
Beckman KA, Syed ZA, Gromacki SJ
Ther Clin Risk Manag · 2026 · PMID 42272563 · Full text
This perspective presents a new conceptual framework for the comprehensive care of patients with keratoconus. Keratoconus is an ectatic degeneration of the cornea associated with progressive vision loss and diminished qu...
This perspective presents a new conceptual framework for the comprehensive care of patients with keratoconus. Keratoconus is an ectatic degeneration of the cornea associated with progressive vision loss and diminished quality of life. Until recently, treatment consisted of optical correction in early stages and corneal transplantation in later stages, neither of which impacted the progressive nature of the disease. The development of corneal cross-linking-a minimally-invasive procedure that stabilizes the disease process and prevents progressive ectasia and vision loss-has significantly altered the therapeutic approach to keratoconus. Until recently, the procedure required removal of the corneal epithelium, but a newly FDA-approved epithelium-on oxygen-enriched option may simplify the process with a favorable benefit-to-risk balance. The FDA indication for this new epithelium-on treatment option also does not require disease progression, further facilitating earlier intervention. Interventional keratoconus management is a novel paradigm characterized by early diagnosis enhanced by new and emerging technology, and early proactive intervention to prevent vision loss and quality of life. Some technologies like epithelium-on oxygen-enriched cross-linking are FDA-approved, while others such as pharmaceutical treatments and customized cross-linking are in development. A decentralized coordinated effort from all eyecare providers, including optometrists, comprehensive ophthalmologists, and corneal surgeons may be necessary for identification of early cases and timely referral for early interventional cross-linking treatment. This approach facilitates preservation of vision and quality of life for patients with keratoconus; it also may reduce the economic burden of keratoconus for health systems and society by reducing the long-term costs of care as well as lost productivity and disability. Development and implementation of a viable community-based, patient-centered, interventional keratoconus care pathway will likely require expanded awareness and education regarding keratoconus and its treatment, as well as creating recommendations and guidelines for healthcare systems and providers to streamline screening, referral, and treatment processes. Given that evidence is emerging and clinical practices are evolving for this novel technology, the paper represents a modern perspective based on a synthesis of available evidence, rather than a traditional consensus guideline.
Transcranial Magnetic Stimulation Combined with Speech-Language Therapy for Post-Stroke Aphasia Recovery: A Systematic Review and Network Meta-Analysis.
Lin J, Bao Y, Fang M … +1 more , Zhang H
Ther Clin Risk Manag · 2026 · PMID 42272562 · Full text
BACKGROUND: Speech-language therapy (SLT) is standard care for post-stroke aphasia (PSA), and adjunctive transcranial magnetic stimulation (TMS) may further improve language function. Which TMS protocol optimally complem...
BACKGROUND: Speech-language therapy (SLT) is standard care for post-stroke aphasia (PSA), and adjunctive transcranial magnetic stimulation (TMS) may further improve language function. Which TMS protocol optimally complements SLT for which language domain at which time point remains unresolved, motivating this network meta-analysis. OBJECTIVE: To compare TMS protocols combined with SLT across immediate and long-term language outcomes in post-stroke aphasia. METHODS: Web of Science, EMBASE, PubMed, and the Cochrane Library were searched from inception to 24 January 2026 for randomized trials of TMS plus SLT in post-stroke aphasia. Bayesian network meta-analyses were run in R 4.4.2 with the gemtc and rjags packages, with outcomes grouped into seven immediate and four long-term language domains and effect sizes reported as standardized mean differences (SMDs) with 95% credible intervals (CrIs). Treatments were ranked by the surface under the cumulative ranking curve (SUCRA), and certainty of evidence was rated using GRADE (Grading of Recommendations Assessment, Development and Evaluation). RESULTS: Across 26 trials enrolling 1,136 patients, three protocols led across the language domains. LF-rTMS+Music+SLT ranked first for immediate aphasia severity (SUCRA = 96.86%), repetition (97.25%), naming (99.69%), and spontaneous speech (95.67%); LF-rTMS+SLT, for writing (87.73%); and Dual-rTMS+SLT, for immediate functional communication (91.49%) and comprehension (97.57%). Dual-rTMS+SLT was also optimal across all four long-term outcomes (overall aphasia severity 95.82%, comprehension 95.06%, naming 99.74%, repetition 97.90%). Heterogeneity was low-to-moderate (moderate-to-high for immediate aphasia severity), and all Bayesian models converged (PSRF < 1.05). Evidence was moderate-to-high for standard comparisons (LF-rTMS+SLT vs SLT) but low to very low for the highest-ranked novel combinations such as LF-rTMS+Music+SLT, driven by imprecision and indirectness. CONCLUSION: The optimal TMS-plus-SLT protocol depends on which language domain and which time point matters. LF-rTMS+Music+SLT led the immediate domains, while Dual-rTMS+SLT led the long-term domains. Standard adjunctive comparisons (e.g. LF-rTMS+SLT vs SLT) rest on moderate-to-high certainty evidence, but the highest-ranked novel combinations rest on low-certainty evidence and require head-to-head confirmation.
Risk Factors for Hypoglycemia in Type 2 Diabetes Mellitus Patients Using Once-Weekly Semaglutide: A Matched Case-Control Study.
Amirthalingam P, Alarawi FA, Jassas Alagwar LM … +11 more , Alatawi MS, Saeed Alfahmi Alzahrani MS, A Albalwi AO, Alrashidi A, Elsaid Hamdan AM, Fahad Alqifari S, Alshareef H, Aljabri A, Sirag N, Pakkir Mohamed SH, Ali MAS
Ther Clin Risk Manag · 2026 · PMID 42266882 · Full text
BACKGROUND: The semaglutide once-weekly injection (Sema-OWI) is widely accepted for managing type-2 diabetes mellitus (T2DM) patients, particularly those seeking weight loss. However, hypoglycemia is continually challeng...
BACKGROUND: The semaglutide once-weekly injection (Sema-OWI) is widely accepted for managing type-2 diabetes mellitus (T2DM) patients, particularly those seeking weight loss. However, hypoglycemia is continually challenging healthcare practitioners, and the underlying factors have yet to be conclusively reported. The study aimed to investigate the underlying characteristics of T2DM patients undergoing sema-OWI treatment. METHODS: A matched case-control study design was employed with a 1:4 (case:control) ratio. Univariable conditional logistic regression was used for the preliminary analysis of the association between patient characteristics and the occurrence of hypoglycemia using a matched odds ratio (mOR). Then, multivariable conditional logistic regression was performed using the predictors, with adjusted mOR (mORadj), including body mass index (BMI) and glycosylated hemoglobin (HbA1C), adjusted for the significant confounders identified in the univariable conditional logistic regression. RESULTS: Forty-five cases diagnosed with the hypoglycemic event and 180 controls were recruited according to a 1:4 (case:control) ratio. According to univariable conditional logistic regression, Patients treated with sema-OWI for 4-6 months (mOR = 0.052; p<0.001) and more than 6 months (mOR = 0.045; p = 0.001) were least likely to experience hypoglycemia. Obese patients (mOR = 0.110; p = 0.041) and those with an HbA1C level >9 (mOR = 0.254; p < 0.001) were also least likely to experience hypoglycemia. According to multivariable conditional logistic regression analysis, the model was adjusted for the number of T2DM medications and Sema-OWI duration, confirming that obesity and higher HbA1C levels (>9) were associated with a lower likelihood of hypoglycemia. On the other hand, the above results establish that the normal body mass index and lower HbA1C levels (<7) were associated with a higher likelihood of hypoglycemia. CONCLUSION: Patients with T2DM treated with sema-OWI require careful monitoring, particularly during the first 3 months. Normal BMI and HbA1C levels <7 are considered risk factors for hypoglycemia.
Extracellular Vesicle-Based Strategies for the Prevention of Chemotherapy-Induced Cardiotoxicity.
Shen Z, Qiu J, Yu W … +2 more , Chen R, Jiang Y
Ther Clin Risk Manag · 2026 · PMID 42266881 · Full text
Chemotherapy-induced cardiotoxicity (CIC) is a major limitation of modern anticancer therapy, particularly with anthracyclines and targeted agents, and contributes to long-term cardiovascular complications in cancer surv...
Chemotherapy-induced cardiotoxicity (CIC) is a major limitation of modern anticancer therapy, particularly with anthracyclines and targeted agents, and contributes to long-term cardiovascular complications in cancer survivors. Extracellular vesicles (EVs) are nanoscale lipid-bilayer particles that mediate intercellular communication through the transfer of proteins, nucleic acids, and lipids. Emerging evidence indicates that EVs play a dual role in CIC. On one hand, EVs released from tumor cells or stressed cardiomyocytes can propagate cardiotoxic signals by modulating pathways related to oxidative stress, mitochondrial dysfunction, apoptosis, and inflammatory responses. On the other hand, EV-associated molecular cargo, including specific microRNAs and proteins, shows promise as minimally invasive biomarkers for early detection and monitoring of cardiac injury during chemotherapy. In addition, EVs derived from stem or progenitor cells, as well as engineered EVs with modified cargo or surface ligands, have demonstrated cardioprotective potential by attenuating oxidative damage, suppressing apoptosis, and modulating immune and inflammatory signaling in the injured myocardium. Despite these advances, several barriers hinder clinical translation, including vesicle heterogeneity, limited targeting specificity, challenges in standardized isolation and characterization, and insufficient safety and efficacy validation. This review summarizes the mechanistic roles of EVs in the development of CIC, highlights their emerging value as diagnostic biomarkers and therapeutic carriers, and discusses current technical challenges and future directions for translating EV-based strategies into clinical cardio-oncology practice.
Association Between Insulin Regimen and Cardiovascular Risk in Indonesian Patients with Type 2 Diabetes Mellitus: A Cross-Sectional Study.
Natsir RM, Halimah E, Diantini A … +1 more , Levita J
Ther Clin Risk Manag · 2026 · PMID 42266880 · Full text
BACKGROUND: Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality among patients with type 2 diabetes mellitus (T2DM). Despite the widespread use of insulin therapy, evidence on how different...
BACKGROUND: Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality among patients with type 2 diabetes mellitus (T2DM). Despite the widespread use of insulin therapy, evidence on how different insulin regimens influence cardiovascular risk stratification remains limited and inconsistent, particularly in Asian populations, including Indonesia. PURPOSE: To evaluate the association between insulin regimens and cardiovascular risk, as assessed by the Framingham Risk Score (FRS), among patients with T2DM. METHODS: A cross-sectional study was conducted involving 118 patients with T2DM receiving insulin therapy, including basal insulin therapy and combined basal-prandial insulin therapy. Cardiovascular risk was assessed using the FRS and categorized as low, moderate, or high. Differences between groups were analyzed using the Chi-square test. The association between insulin regimen and cardiovascular risk was evaluated using ordinal logistic regression. RESULTS: Most patients in both treatment groups were classified as having high cardiovascular risk according to the FRS. After adjustment for potential confounders, the insulin regimen was not significantly associated with cardiovascular risk (OR = 2.14; 95% CI: 0.81-5.65; p = 0.124). In contrast, the duration of T2DM was significantly associated with cardiovascular risk (OR = 3.63; 95% CI: 1.30-10.15; p = 0.014). CONCLUSION: Cardiovascular risk among patients with T2DM receiving insulin therapy was predominantly moderate to high. The insulin regimen was not significantly associated with cardiovascular risk, whereas the duration of T2DM played a more prominent role in cardiovascular risk stratification.
Real-World Evidence for Combination Sedation: Propofol Plus Dexmedetomidine and Clinical Outcomes in Mechanically Ventilated ICU Patients.
Qi J, Gao W, Ni Q … +4 more , Liang Z, Wang W, Qiao T, Wang B
Ther Clin Risk Manag · 2026 · PMID 42233162 · Full text
PURPOSE: This retrospective multicenter cohort study evaluated the real-world effectiveness of propofol alone versus a propofol-plus-dexmedetomidine combination on clinical outcomes in mechanically ventilated ICU patient...
PURPOSE: This retrospective multicenter cohort study evaluated the real-world effectiveness of propofol alone versus a propofol-plus-dexmedetomidine combination on clinical outcomes in mechanically ventilated ICU patients. METHODS: Adult mechanically ventilated ICU patients receiving long-term continuous infusion sedation (≥48 h) with either propofol alone or propofol plus dexmedetomidine were identified from the MIMIC-IV and eICU databases. An external validation cohort from Nanjing Drum Tower Hospital (2013-2022) was assembled using the same eligibility criteria. Patients were categorized into a propofol monotherapy group (Pro) and a propofol plus dexmedetomidine group (Pro+Dex). Outcomes included 28-day all-cause mortality, incident delirium, ICU length of stay, duration of mechanical ventilation, and longitudinal changes in mean arterial pressure, heart rate, and oxygen saturation. RESULTS: Among 5495 patients (Pro: n=4730; Pro+Dex: n=765), the Pro+Dex regimen was associated with lower 28-day mortality (adjusted HR: 0.45, 95% CI: 0.36-0.56; P < 0.001) and a markedly reduced incidence of delirium (adjusted OR: 0.28, 95% CI: 0.21-0.37; P < 0.001), but with a modestly longer ICU stay (13.07 vs 10.60 days; adjusted ratio: 1.23, 95% CI: 1.18-1.29). Mechanical ventilation duration did not differ significantly between groups (154.79 vs 157.64 hours; adjusted ratio: 0.98, 95% CI: 0.92-1.05). Longitudinal mixed-effects models suggested a more stable MAP trajectory and lower HR with Pro+Dex, while SpO was slightly lower on average but remained stable over time. Subgroup analyses were broadly consistent with the overall cohort. In the external validation cohort, Pro+Dex was also associated with significantly lower 28-day mortality, whereas the reduction in delirium incidence did not reach statistical significance. CONCLUSION: In this large real-world multicenter study, combination sedation with propofol and dexmedetomidine was associated with lower 28-day mortality and a lower risk of delirium, without a significant difference in mechanical ventilation duration, although ICU length of stay was modestly longer.
Maternal, Fetal, and Neonatal Outcomes of Additional Dihydroartemisinin-Piperaquine to Trimethoprim-Sulfamethoxazole in Intermittent Preventive Treatment for Malaria in HIV-Positive Pregnancies: A Systematic Review and Meta-Analysis.
Yunivita V, Maharani AJ, Bernadus CA … +2 more , Sinaga EIJ, Simanjuntak ER
Ther Clin Risk Manag · 2026 · PMID 42226932 · Full text
PURPOSE: This systematic review evaluates the addition of Dihydroartemisinin-Piperaquine (DHA-PPQ) to Trimethoprim-Sulfamethoxazole (TMP-SMX) for Intermittent Preventive Treatment (IPT) in HIV-positive pregnancies, focus...
PURPOSE: This systematic review evaluates the addition of Dihydroartemisinin-Piperaquine (DHA-PPQ) to Trimethoprim-Sulfamethoxazole (TMP-SMX) for Intermittent Preventive Treatment (IPT) in HIV-positive pregnancies, focusing on its effects on malaria infection, maternal adverse events, fetal adverse events, and birth outcomes. PATIENTS AND METHODS: Following PRISMA guidelines, we searched PubMed, Cochrane, Google Scholar, and Scopus until December 16, 2024. Out of 390 studies, three were included, assessed for bias using ROB 2.0, and analyzed with random-effects meta-analysis in RevMan 5.4.1. RESULTS: We analyzed three studies involving 1353 participants who received 800/160 mg of TMP-SMX, with or without 40/320 mg of DHA-PPQ administered three times. The addition of DHA-PPQ showed a non-significant trend toward lower malaria infection outcomes, including maternal parasitaemia (OR: 0.83; 95% CI [0.52, 1.33], p = 0.44) and rates of placental malaria (OR: 0.66; 95% CI [0.40, 1.08], p = 0.10). DHA-PPQ significantly lowered maternal adverse events (OR: 0.78; 95% CI [0.67, 0.91], p = 0.003), which included low hemoglobin (OR: 0.83; 95% CI [0.69, 1.00], p = 0.05), gastrointestinal events (OR: 0.66; 95% CI [0.46, 0.95], p = 0.03), neurological events (OR: 0.61; 95% CI [0.22, 1.69], p = 0.35), and skin reactions (OR: 0.40; 95% CI [0.08, 2.11], p = 0.28). No significant differences were observed in fetal adverse events (OR: 1.05; 95% CI [0.68, 1.65], p = 0.69), which comprised spontaneous abortion (OR: 1.81; 95% CI [0.60, 5.51], p = 0.30), stillbirth (OR: 1.02; 95% CI [0.55, 1.89], p = 0.95), and congenital anomalies (OR: 0.89; 95% CI [0.32, 2.47], p = 0.83). Finally, no significant effect was observed on birth outcomes (OR: 1.13; 95% CI [0.88, 1.45], p = 0.81), including low birth weight (OR: 1.15; 95% CI [0.85, 1.56], p = 0.36) and premature birth (OR: 1.08; 95% CI [0.70, 1.68], p = 0.73). CONCLUSION: Additional DHA-PPQ shows promising efficacy in reducing malaria infection, a statistically significant reduction in maternal adverse events, with no significant differences in fetal and birth outcomes.
Impact of Early versus Delayed Vasopressin Initiation on 28-Day Mortality in Older Adults with Septic Shock.
Liu L, Shi H, Zhang L … +1 more , Ma J
Ther Clin Risk Manag · 2026 · PMID 42222740 · Full text
BACKGROUND: The optimal timing for initiating adjunctive vasopressin in septic shock remains controversial, with limited evidence specific to older adults who may have altered physiological responses. This study aimed to...
BACKGROUND: The optimal timing for initiating adjunctive vasopressin in septic shock remains controversial, with limited evidence specific to older adults who may have altered physiological responses. This study aimed to investigate the association between the timing of vasopressin initiation and 28-day mortality in older adults with septic shock. METHODS: In this retrospective observational cohort study, we enrolled 197 older adults (≥65 years) with septic shock who received vasopressin within 72 hours of norepinephrine initiation. Patients were categorized into an early group (vasopressin within 6 hours of norepinephrine; n=119) and a delayed group (vasopressin between 6-72 hours; n=78). The primary outcome was 28-day all-cause mortality, analyzed using multivariable Cox regression adjusting for potential confounders. RESULTS: The 28-day mortality was significantly lower in the early vasopressin group compared to the delayed group (36.1% vs. 57.7%, <0.01). In the multivariate Cox analysis, early initiation was independently associated with a reduced risk of 28-day mortality (HR = 0.48, 95% CI: 0.31-0.74, p < 0.01). Secondary outcomes also favored the early group, including a higher rate of hemodynamic response (62.2% vs. 44.9%, =0.02), more mechanical ventilation-free days (11.9 vs. 8.4 days, =0.03) and more continuous renal replacement therapy (CRRT)-free days (13.2 vs. 9.5 days, =0.03). CONCLUSION: In older adults with septic shock, early initiation of vasopressin within six hours of norepinephrine commencement was independently associated with significantly lower 28-day mortality and improved hemodynamic and organ function outcomes.
Exploring the Current Tools for Fall Risk Assessment in Older Adults Across Southeast Asia and the Need for Culturally Adapted Models: A Scoping Review.
Dharmansyah D, Rahayuwati L, Pramukti I … +1 more , Mutyara K
Ther Clin Risk Manag · 2026 · PMID 42205543 · Full text
BACKGROUND: Falls are a leading cause of unintentional injury, functional disability, and premature mortality among older adults worldwide, ranking second among causes of unintentional injury-related death globally accor...
BACKGROUND: Falls are a leading cause of unintentional injury, functional disability, and premature mortality among older adults worldwide, ranking second among causes of unintentional injury-related death globally according to the World Health Organization (WHO), with the burden disproportionately concentrated in low- and middle-income countries, including those across Southeast Asia (SEA). Assessing fall risk is central to primary prevention; however, it remains unclear which tools are recommended or validated for clinical practice across the 11 nations of the Association of Southeast Asian Nations (ASEAN) and whether existing Western-developed instruments adequately account for culturally specific risk determinants in this region. AIM: This scoping review aimed to identify, review, and map the available literature on fall risk assessment tools used in older adults across SEA countries and to explore the extent to which cultural practices and local wisdom influence their applicability and the need for culturally adapted models. METHODS: This scoping review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the Joanna Briggs Institute (JBI) methodology. Searches were conducted in March 2026 in the Scopus, PubMed/MEDLINE, and Web of Science (WoS) databases. English-language, full-text articles published between 2015 and 2025 from the 11 ASEAN countries were eligible; open-access status was preferred but non-open-access records were also obtained via institutional subscription and author contact. The protocol was pre-registered on the Open Science Framework (OSF; https://doi.org/10.17605/OSF.IO/5DHXK). RESULTS: Thirty-two primary-data studies from Thailand (n=12), Malaysia (n=10), Indonesia (n=5), Vietnam (n=3), and Singapore (n=2) met the inclusion criteria; three additional regional secondary reviews informed cut-off triangulation. Twelve fall risk tool categories were identified. Western tools dominated (84.4% of primary-data studies) with minimal cultural adaptation. The Timed Up and Go (TUG) test was the most frequently used instrument (25/32 studies), but it showed variable cut-off values (8-14.3 s). Six ASEAN countries had no eligible primary studies. The weighted mean proportion of female participants was 63.4%; community-dwelling samples predominated (65.6%). CONCLUSION: Current fall risk assessment research in SEA is geographically concentrated and dominated by unadapted Western tools. Cultural practices central to SEA - floor-level mobility, barefoot ambulation, and domestic environmental hazards - are systematically unaddressed. Urgent investment in culturally adapted tool development, multicentre validation, and digital scaling is required across ASEAN. We propose an integrative framework, Southeast Asian Fall Assessment for Living and Locality (SEA-FALL), to guide future validation and policy translation.
The ESINEA Study: A Novel Screening Tool for Identifying Patient Safety Incidents and Adverse Events in Hospitalized Patients-An Index-Date Cohort Evaluation.
Dueñas Lopez FC, Fernández-Arroyo García A, Rivera Núñez MA … +30 more , Díaz-Pollán B, Sobrino Jiménez C, Murillo Gayo C, Mendieta Azcona C, Jiménez Núñez C, Yagüe de Antonio G, Narrillos Martín I, Guijarro Eguinoa J, Ojeda Feo JJ, González de la Viuda MA, Bautista Reina MDC, Fernández Velilla Peña M, Jiménez-Gonzalez M, Duque Alcorta M, Álvarez-Montero M, González Muñoz M, Lorente Romeo M, Buitrago Sánchez NM, Rogozina O, López Ortego P, Pardo Puras R, Torres Santos Olmo RM, Iniesta Pérez S, Chajma Izquierdo S, Martín López S, Del Rosal T, Parra Ramírez P, Villán Villán YF, Martín Vega A, Ramírez E
Ther Clin Risk Manag · 2026 · PMID 42199639 · Full text
BACKGROUND: This study, ESINEA, investigated the period prevalence and characteristics of Patient Safety Incidents (PSIs) at La Paz University Hospital. PSIs were operationally defined as healthcare-related events with t...
BACKGROUND: This study, ESINEA, investigated the period prevalence and characteristics of Patient Safety Incidents (PSIs) at La Paz University Hospital. PSIs were operationally defined as healthcare-related events with the potential to cause patient harm, including near misses, incidents, and adverse events (AEs) resulting in actual injury. Recognizing the critical importance of patient safety and the limitations of existing AE detection methods, the study aimed to improve identification and understanding of these incidents. METHODOLOGY: An index-date inpatient cohort study was conducted, including all patients hospitalized at La Paz University Hospital on April 23, 2023 (n=870 episodes), with follow-up from admission to discharge. The methodology involved two phases: (i) electronic health records screening using a novel trigger-based tool, and (II) expert adjudication to confirm the PSIs and AEs, serving as the reference standard for tool validation. RESULTS: The population showed a high rate of urgent admissions (79%) and a predominance of older patients (75-85 years old, 19.5%). Phase I identified at least one positive screening trigger in 58% of patients. Following expert adjudication, the period prevalence of PSI was 47.9% (95%CI: 45.16-50.72), and AEs were confirmed in 27% (95% CI: 24.17-30.06). Phase II confirmed that PSI accounted for 92.35% of the positive screening. The most frequent incidents occurred during "patient care and follow-up" (29.95%), followed by "Healthcare-Associated Infections" (17.21%). Vulnerability to PSI was significantly higher among older patients, those with longer hospital stays, and those with higher comorbidity burdens. Although 34.17% of PSIs were deemed preventable, slightly lower than the expected 40%;the analysis identified 88 distinct types of improvement actions to enhance patient safety. CONCLUSION: The ESINEA study identified a high period prevalence of AEs (27%) in hospitalized patients, which is higher than the estimated 10% prevalence often cited. Although direct comparisons require caution due to differences in detection sensitivity and study design, these findings underscore the need for enhanced care coordination, infection prevention, and stricter protocol adherence, particularly among vulnerable populations.
Adjunctive Cannabidiol for Drug-Resistant Epilepsy: A Systematic Review and Meta-Analysis of Randomized Trials Across Syndromes, Formulations, and Dose Ranges.
Pratama R, Muhaimin M, Khairinisa MA … +1 more , Chaerunisaa AY
Ther Clin Risk Manag · 2026 · PMID 42179430 · Full text
BACKGROUND: Cannabidiol (CBD) has emerged as a promising adjunctive therapy for drug-resistant epilepsy, yet clinical findings remain heterogeneous across trials. This meta-analysis aimed to evaluate the efficacy, safety...
BACKGROUND: Cannabidiol (CBD) has emerged as a promising adjunctive therapy for drug-resistant epilepsy, yet clinical findings remain heterogeneous across trials. This meta-analysis aimed to evaluate the efficacy, safety, and formulation-dependent performance of CBD in patients with treatment-resistant epilepsies. METHODS: A systematic review and meta-analysis were conducted in accordance with PRISMA 2020 guidelines, including randomized, double-blind, placebo-controlled trials of adjunctive CBD in drug-resistant epilepsy. Literature was sourced from PubMed/MEDLINE, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL). Data were synthesized using random-effects models to estimate pooled risk ratios (RRs) with 95% confidence intervals (CIs) for seizure reduction and adverse events. Subgroup analyses explored the influence of epilepsy syndrome, CBD dose, and formulation type. RESULTS: Seven randomized controlled trials involving 1154 participants met inclusion criteria. Adjunctive CBD significantly reduced seizure frequency compared with placebo (pooled RR = 0.72, 95% CI 0.71-0.73; p < 0.0001). The effect was consistent across Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex, with optimal efficacy observed at 20 mg/kg per day of highly purified oral CBD. Liposomal CBD produced modest benefit, whereas transdermal formulations showed no short-term efficacy. Adverse events were predominantly mild and comparable to placebo, although elevations in hepatic enzymes and somnolence occurred more frequently in patients receiving concomitant valproate or clobazam. CONCLUSION: Adjunctive oral CBD provides a reproducible and clinically meaningful reduction in seizures in drug-resistant epilepsy, with an acceptable safety profile. Oral CBD at 20 mg/kg per day represents the current benchmark for efficacy, while alternative formulations require further evaluation. Future research should address long-term outcomes, optimal dosing strategies, and formulation refinement to improve tolerability and accessibility in diverse epileptic populations.
Effects of TUS-NMES Combined with Glucocorticoid on Clinical Outcomes and Rehabilitation Efficacy of Neurosyphilis Patients with Cerebral Infarction.
Dai J, He F, Xu Y … +8 more , Lei N, Zhang D, He W, Zhu F, Chen S, Shan X, Wu M, Zhang X
Ther Clin Risk Manag · 2026 · PMID 42170220 · Full text
OBJECTIVE: To investigate the effects of transcranial ultrasound-neuromuscular electrical stimulation (TUS-NMES) combined with glucocorticoid (GC) as adjunctive intervention to standard penicillin therapy on clinical out...
OBJECTIVE: To investigate the effects of transcranial ultrasound-neuromuscular electrical stimulation (TUS-NMES) combined with glucocorticoid (GC) as adjunctive intervention to standard penicillin therapy on clinical outcomes and rehabilitation efficacy in neurosyphilis (NS) patients with cerebral infarction. METHODS: A total of 309 NS patients with cerebral infarction were randomly divided into general group (N = 79, penicillin), GC group (N = 77, penicillin and GC), TUS-NMES group (N = 75, penicillin and TUS-NMES), and combination group (N = 78, penicillin and GC & TUS-NMES). Baseline data, clinical symptoms, laboratory indicators, Fugl-Meyer assessment scale (FMA), and National Institute of Health stroke scale (NIHSS) scores before and after treatment were compared. Twelve-month rehabilitation outcomes were analyzed using Kaplan-Meier curves. RESULTS: No serious adverse events occurred during treatment; only mild, transient discomforts, including slight scalp tingling, local muscle tremor, headache, and insomnia, were reported, all of which were alleviated after timely management and did not significantly affect the treatment process or patient recovery. After treatment, all groups showed significant improvement ( < 0.05), with the combination group demonstrating the greatest effect, including prolonged prothrombin time, higher nitric oxide, lower NIHSS, and higher FMA scores. At 12 months, the combination group (43.59%) showed a higher treatment improvement rate than the general (25.32%) and GC (27.27%) groups ( < 0.05), as well as the optimal recovery effect. CONCLUSION: TUS-NMES combined with GC, as an adjunct to standard penicillin therapy, improves clinical symptoms, coagulation, and neurological function, and enhances rehabilitation outcomes in NS patients with cerebral infarction.
Predicting Sensory Block Level in Caudal Anesthesia Based on Sacral Canal Anatomical Parameters and Height: Development of an Ordinal Logistic Regression Model and Nomogram.
Li Z, Wu H, Zhang S … +3 more , Yu S, Liu L, Liufu N
Ther Clin Risk Manag · 2026 · PMID 42153217 · Full text
BACKGROUND: Caudal block in clinical practice relies on empirical drug administration without reliable prediction of anesthetic level, thereby limiting its application. This study aimed to develop a predictive model for...
BACKGROUND: Caudal block in clinical practice relies on empirical drug administration without reliable prediction of anesthetic level, thereby limiting its application. This study aimed to develop a predictive model for sensory block level based on sacral canal anatomical factors and patient characteristics. METHODS: A total of 132 patients undergoing elective anal surgery with caudal block were included. Ultrasound measured anatomical parameters (the width of the base of the sacrum (BSW), the anterior-posterior diameter of the sacral hiatus at its apex (SHAP), the anterior-posterior diameter of the sacral hiatus at the first segment inferior to the apex (SHFSIA-AP), the length of the sacral hiatus in the sagittal plane (SHLS) and demographic data (age, gender, height, weight) were collected. Sensory block level was categorized into five ordinal grades. Multivariable ordinal logistic regression identified independent predictors, with variance inflation factor (VIF) assessing multicollinearity and Brant test verifying proportional odds assumption. Model performance was evaluated via concordance index (C-index) and Lipsitz test, with internal validation performed using bootstrapping with 1000 resamples, and a nomogram was constructed. RESULTS: Univariable analysis showed SHAP, SHLS, SHFSIA-AP, height, age, gender, and weight correlated with sensory block level (<0.05). Final independent predictors were SHAP, SHLS, and height. No multicollinearity (VIF<5) and valid proportional odds assumption (Brant test =0.36) were confirmed. The model had good predictive performance (C-index=0.881, 95% CI [0.809-0.953]) and fit (Lipsitz test =0.49), with the nomogram visualizing probabilities of each block level category. CONCLUSION: This study identified SHAP, SHLS, and height as predictors for caudal block sensory level. The nomogram enables individualized, precise drug administration, shifting the technique from experience-based to precision prediction.
Staged Management of Bone Defects in Chronic Osteomyelitis and Nonunions Using Antibiotic-Loaded Calcium Sulphate-Hydroxyapatite: A Multicenter Retrospective Analysis of 101 Cases.
Armbruster J, Mattern N, Lamadé-Dootz F … +5 more , Steinhausen ES, Reiter G, Dudda M, Grützner PA, Freischmidt H
Ther Clin Risk Manag · 2026 · PMID 42131866 · Full text
PURPOSE: To evaluate the clinical outcomes of an antibiotic-loaded calcium sulphate-hydroxyapatite biocomposite (ALB) used specifically in staged surgical protocols for chronic osteomyelitis and nonunions, including larg...
PURPOSE: To evaluate the clinical outcomes of an antibiotic-loaded calcium sulphate-hydroxyapatite biocomposite (ALB) used specifically in staged surgical protocols for chronic osteomyelitis and nonunions, including large bone defects resulting from the necessary debridement of necrotic bone. PATIENTS AND METHODS: This retrospective multicenter study analyzed 101 patients treated between 2013 and 2020. Inclusion criteria comprised adult patients with bone defects resulting from osteomyelitis, septic nonunion, or aseptic nonunion, treated with ALB (gentamicin or vancomycin) in a staged procedure. The primary outcome was treatment success, defined as infection eradication and stable bone consolidation without unplanned surgical revision. Secondary outcomes included revision rates, reinfection rates, and biomaterial-related side effects such as white drainage. RESULTS: Treatment success was achieved in 30.7% of patients. The overall revision rate was 58.4%, and the reinfection rate was 45.5%. The mean defect size was 4.1 cm. Statistical analysis identified larger defect sizes and higher volumes of implanted ALB as significant risk factors for failure. "White drainage" was observed in 13.9% of patients and was significantly associated with the use of larger material volumes. CONCLUSION: The use of ALB in staged protocols for large bone defects is associated with high revision and reinfection rates. These findings identify the limits of the technique and sharpen its indication spectrum, standing alongside the favorable outcomes reported for single-stage procedures in smaller defects. In large defects, the resorption of the carrier may outpace bone ingrowth, leading to recurrence of infection. Consequently, the use of ALB in large defects cannot be recommended based on these data.
Effects of Intravenous Esketamine or Magnesium Sulfate on Early Postoperative Negative Emotions and Pain in Patients Undergoing Endoscopic Sinus Surgery: A Randomized Controlled Trial.
Wang L, Zhou J, Liu Q … +3 more , Qian K, Wang L, Xie C
Ther Clin Risk Manag · 2026 · PMID 42125734 · Full text
BACKGROUND: N-methyl-D-aspartate (NMDA) receptor antagonists are crucial for managing perioperative pain and psychological distress. Both esketamine and magnesium sulfate are NMDA receptor antagonists. This study compare...
BACKGROUND: N-methyl-D-aspartate (NMDA) receptor antagonists are crucial for managing perioperative pain and psychological distress. Both esketamine and magnesium sulfate are NMDA receptor antagonists. This study compared their effects on early postoperative negative emotions and pain in patients undergoing endoscopic sinus surgery (ESS). METHODS: This study involved 137 patients scheduled for ESS were randomly assigned to three groups: Group E (esketamine), Group M (magnesium sulfate), and Group C (saline control). Before induction, Group E received esketamine 0.25 mg/kg loading over 10 min then 0.25 mg/(kg·h) infusion until surgery end; Group M received magnesium sulfate 30 mg/kg loading over 10 min then 10 mg/(kg·h) infusion until surgery end; Group C received equal volume of normal saline. Hospital Anxiety and Depression Scale (HADS) and Self-rating Anxiety/Depression Scale (SAS/SDS) scores were assessed on postoperative days 1 and 2 (POD1, POD2). VAS scores, hemodynamics, intraoperative drug use, and adverse events were also evaluated. RESULTS: On POD1, HADS, SAS, and SDS scores were significantly lower in Groups E and M than in Group C (< 0.05). On POD2, these scores were lower in Group E than in Groups C and M(<0.05). VAS pain scores were significantly lower in Groups E and M at 2, 4, and 8 hours postoperatively (<0.001). Remifentanil consumption was lower in Groups E and M than in Group C (<0.05), nitroglycerin consumption was lower in Group M than in Group E (<0.05). Incidences of sore throat, rescue analgesia, postoperative respiratory depression, and PONV in Groups E and M were significantly lower than those in Group C (<0.05). CONCLUSION: Intravenous esketamine or magnesium sulfate effectively alleviated negative emotions and pain on POD1 in patients undergoing ESS.Esketamine demonstrated superior efficacy over magnesium sulfate on POD2.
Mesenchymal Stromal Cells in Knee Osteoarthritis: A Review of Nomenclature, Criteria, and Therapeutic Mechanisms.
Lim DH, Lee CC, Park KB
Ther Clin Risk Manag · 2026 · PMID 42125733 · Full text
Cell-based therapies, particularly utilizing mesenchymal cells, have garnered significant global attention for treating knee osteoarthritis (OA). However, interpreting clinical outcomes remains challenging due to substan...
Cell-based therapies, particularly utilizing mesenchymal cells, have garnered significant global attention for treating knee osteoarthritis (OA). However, interpreting clinical outcomes remains challenging due to substantial heterogeneity in study designs, cell sources, and preparation methods. This narrative review aims to clarify the evolving nomenclature, outline defining criteria, and elucidate the fundamental mechanisms of these therapies. We highlight the critical scientific transition from "mesenchymal stem cells" to "mesenchymal stromal cells", an adjustment strongly supported by recent clinical approvals emphasizing immune recalibration over direct tissue regeneration. Currently, robust evidence indicates that mesenchymal stromal cells exert their therapeutic effects primarily through paracrine signaling and immunomodulation, predominantly orchestrated by exosomes, rather than through lineage-driven direct structural repair. Furthermore, we address the practical implications of cell processing-differentiating between minimal manipulation (e.g. cell concentrates) and in vitro expansion-and the stringent regulatory frameworks governing them. Ultimately, standardizing the mechanism-accurate "stromal" terminology and optimizing cell preparation protocols are essential steps for advancing the efficacy and reliability of regenerative treatments in knee OA.
Outcome of Emergent ABO-Incompatible Liver Transplantation is Acceptable but at the Cost of Higher Diffuse Intrahepatic Biliary Stricture: A Single-Center, Retrospective Study.
Liu J, Qi J, Chen Y … +5 more , Duan X, Yu X, Jin P, Zhang Y, Zhang W
Ther Clin Risk Manag · 2026 · PMID 42116830 · Full text
OBJECTIVE: The efficacy and clinical outcomes of emergent rituximab-based desensitization therapy in ABO-incompatible liver transplantation (ABO-I LT) remain poorly characterized. In this study, we analyzed a single-cent...
OBJECTIVE: The efficacy and clinical outcomes of emergent rituximab-based desensitization therapy in ABO-incompatible liver transplantation (ABO-I LT) remain poorly characterized. In this study, we analyzed a single-center cohort of emergency ABO-I LT recipients to delineate key clinical features and identify independent predictors of post-transplant survival. METHODS: Between January 1, 2015, and August 31, 2021, 1015 (90.2%) recipients received ABO-compatible (ABO-C) deceased donor liver transplantation (DDLT), and 110 (9.8%) received ABO-I DDLT with emergent rituximab-based desensitization. RESULTS: The ABO-C and ABO-I DDLT groups were followed up for 49.6 and 43.6 months, respectively. Following 1:1 propensity score matching (n=110 per group), the ABO-I group exhibited lower survival rates compared to the ABO-C group at 1, 3, and 5 years (74.0%, 68.5%, and 65.5% vs 88.0%, 83.0%, and 80.7%; = 0.024). Multivariate analysis identified age > 65 years, liver cancer pre-transplantation, intraoperative blood loss > 1000 mL, and diffuse intrahepatic biliary stricture (DIHBS) as independent risk factors for patient survival. Crucially, after excluding DIHBS, survival outcomes between the two groups were comparable ( = 0.336). CONCLUSION: Emergent ABO-I LT with an adjusted desensitization protocol is feasible but associated with inferior survival due to a higher incidence of DIHBS. This disparity underscores the need for refined strategies to mitigate DIHBS and improve ABO-I LT outcomes.
Prevention and Care of Pressure Ulcers in Long-Term Bedridden Adult and Older Adult Patients in the Community: A Systematic Review.
Meng L, Banharak S, Sommana C … +3 more , Ransinyo K, Cheumnok W, Tian J
Ther Clin Risk Manag · 2026 · PMID 42111681 · Full text
Pressure injuries remain a significant and costly complication among long-term bedridden adult and older adult patients, leading to increased morbidity, complications, and a diminished quality of life. This review aimed...
Pressure injuries remain a significant and costly complication among long-term bedridden adult and older adult patients, leading to increased morbidity, complications, and a diminished quality of life. This review aimed to summarize interventions for the prevention and care of pressure ulcers among long-term bedridden adult and older adult patients in the community. Fourteen databases were searched from March 2013 to March 2024, yielding 16 studies for final analysis. Two interconnected core elements were identified: 1) multidimensional intervention pathways and 2) three targeted preventive measures. The pathways include face-to-face education/training, home visits, digital tools (WeChat/smartphone apps), multidisciplinary collaboration, and remote follow-up. The targeted measures-position management with pressure-relief techniques, skin integrity maintenance, and nutritional/fluid support-were associated with improvements in PU-related outcomes: combined repositioning and pressure-relief devices were associated with lower PU incidence, temperature-controlled skin care with zinc oxide was associated with reduced skin redness, high-protein diets and omega-3 supplements were associated with improved skin resilience and barrier function, and integrated protocols (Braden-stratified repositioning/app monitoring) may improve care efficiency. Limitations included heterogeneity in study designs and outcome measures, incomplete reporting of implementation details, and limited geographical representation, as most were conducted in China (14/16), with only one study each from Finland and India. The certainty of evidence ranged from very low to moderate across outcomes; therefore, the findings should be interpreted cautiously. This review highlights potentially adaptable strategies for community-based PU prevention and care. It underscores the need for standardized, long-term studies to enhance the generalizability and sustainability of intervention strategies. : CRD42024524789.
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