1.Analysis of the global registration status of clinical trials for artificial intelligence medical device.
Yan LU ; Juan CHEN ; Ting ZHANG ; Shu YAN ; Dongzi XU ; Zhaolian OUYANG
Journal of Biomedical Engineering 2025;42(3):512-519
The rapid development of artificial intelligence technology is driving profound changes in medical practice, particularly in the field of medical device application. Based on data from the U.S. clinical trials registry, this study analyzes the global registration landscape of clinical trials involving artificial intelligence-based medical devices, aiming to provide a reference for their clinical research and application. A total of 2 494 clinical trials related to artificial intelligence medical devices have been registered worldwide, with participation from 66 countries or regions. The United States leads with 908 trials, while for other countries or regions, including China, each has fewer than 300 trials. Germany, the United States, and Belgium serve as central hubs for international collaboration. Among the sponsors, 63.96% are universities or hospitals, 22.36% are enterprises, and the remainder includes individuals, government agencies and others. Of all trials, 79.99% are interventional studies, 94.67% place no restrictions on participant gender, and 69.69% exclude children. The targeted diseases are primarily neurological and mental disorders. This study systematically reveals the global distribution characteristics and research trends of artificial intelligence medical device clinical trials, offering valuable data support and practical insights for advancing international collaboration, resource allocation, and policy development in this field.
Artificial Intelligence
;
Humans
;
Clinical Trials as Topic/statistics & numerical data*
;
Equipment and Supplies
;
Registries
;
United States
2.Postoperative Complications and 30-day Readmission in Patients Older than 80 Years with Chronic Kidney Disease after Hip Fracture.
Hua-Wen ZHANG ; Lu-Lu MA ; Xue-Rong YU
Chinese Medical Sciences Journal 2025;40(3):188-196
OBJECTIVES:
This study aimed to explore the impact of chronic kidney disease (CKD) on prognosis of patients older than 80 years after hip fracture.
METHODS:
This retrospective, observational, single-center study included patients older than 80 years who underwent hip fracture operations between Feburary 2013 to June 2021 at our hospital. Patients were divided into CKD and non-GKD groups based on the estimated glomerular filtration rate (eGFR) < 60 mL/(min·1.73m2)] or not. Outcomes were the incidence of in-hospital postoperative infectious and non-infectious complications, 30-day readmission, and in-hospital death. Logistic regression analysis was used to calculate the odds ratio (OR) of CKD on these outcomes.
RESULTS:
A total of 498 patients were included, 165 in the CKD group and 333 in the non-CKD group. Eighty-seven (52.7%) CKD patients experienced 140 episodes of postoperative complications. In comparison, 114 (34.2%) non-CKD patients had 158 episodes of postoperative complications. CKD patients were more likely to have postoperative complications than non-CKD patients (OR = 2.143, 95% CI: 1.465-3.134, P < 0.001). CKD increased the risk of cardiovascular complications (OR = 2.044, 95% CI: 1.245-3.356, P = 0.004), acute kidney injury (OR = 3.401, 95% CI: 1.905-6.072, P < 0.001), delirium (OR = 2.276, 95% CI: 1.140-4.543, P = 0.024), and gastrointestinal bleeding (OR = 4.151, 95% CI: 1.025-16.812, P = 0.031). The transfusion rate (OR = 2.457, 95% CI: 1.668-3.618, P < 0.001) and incidence of 30-day readmission (OR = 2.426, 95% CI:1.203-4.892, P = 0.011) in CKD patients were significantly higher than those in patients without CKD.
CONCLUSIONS
CKD is associated with poor postoperative outcomes in geriatric hip fracture patients. Special attention should be paid to patients with CKD.
Humans
;
Renal Insufficiency, Chronic/physiopathology*
;
Aged, 80 and over
;
Postoperative Complications/epidemiology*
;
Hip Fractures/complications*
;
Male
;
Female
;
Patient Readmission/statistics & numerical data*
;
Retrospective Studies
;
Glomerular Filtration Rate
3.Gallstones, cholecystectomy, and cancer risk: an observational and Mendelian randomization study.
Yuanyue ZHU ; Linhui SHEN ; Yanan HUO ; Qin WAN ; Yingfen QIN ; Ruying HU ; Lixin SHI ; Qing SU ; Xuefeng YU ; Li YAN ; Guijun QIN ; Xulei TANG ; Gang CHEN ; Yu XU ; Tiange WANG ; Zhiyun ZHAO ; Zhengnan GAO ; Guixia WANG ; Feixia SHEN ; Xuejiang GU ; Zuojie LUO ; Li CHEN ; Qiang LI ; Zhen YE ; Yinfei ZHANG ; Chao LIU ; Youmin WANG ; Shengli WU ; Tao YANG ; Huacong DENG ; Lulu CHEN ; Tianshu ZENG ; Jiajun ZHAO ; Yiming MU ; Weiqing WANG ; Guang NING ; Jieli LU ; Min XU ; Yufang BI ; Weiguo HU
Frontiers of Medicine 2025;19(1):79-89
This study aimed to comprehensively examine the association of gallstones, cholecystectomy, and cancer risk. Multivariable logistic regressions were performed to estimate the observational associations of gallstones and cholecystectomy with cancer risk, using data from a nationwide cohort involving 239 799 participants. General and gender-specific two-sample Mendelian randomization (MR) analysis was further conducted to assess the causalities of the observed associations. Observationally, a history of gallstones without cholecystectomy was associated with a high risk of stomach cancer (adjusted odds ratio (aOR)=2.54, 95% confidence interval (CI) 1.50-4.28), liver and bile duct cancer (aOR=2.46, 95% CI 1.17-5.16), kidney cancer (aOR=2.04, 95% CI 1.05-3.94), and bladder cancer (aOR=2.23, 95% CI 1.01-5.13) in the general population, as well as cervical cancer (aOR=1.69, 95% CI 1.12-2.56) in women. Moreover, cholecystectomy was associated with high odds of stomach cancer (aOR=2.41, 95% CI 1.29-4.49), colorectal cancer (aOR=1.83, 95% CI 1.18-2.85), and cancer of liver and bile duct (aOR=2.58, 95% CI 1.11-6.02). MR analysis only supported the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer. This study added evidence to the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer, highlighting the importance of cancer screening in individuals with gallstones.
Humans
;
Mendelian Randomization Analysis
;
Gallstones/complications*
;
Female
;
Male
;
Cholecystectomy/statistics & numerical data*
;
Middle Aged
;
Risk Factors
;
Aged
;
Adult
;
Neoplasms/etiology*
;
Stomach Neoplasms/epidemiology*
4.Global, regional and national burden and trends of congenital musculoskeletal and limb deformities among under-5 children from 1990 to 2021: a systematic analysis for the Global Burden of Disease Study 2021.
Qinglin YANG ; Zhuanmei JIN ; Yongping WANG
Frontiers of Medicine 2025;19(5):807-819
Congenital musculoskeletal and limb deformities (CMLD) seriously affect the physical and mental health of patients, and pose great challenges to healthcare systems worldwide. We explored the specific situation and changes of incidence, prevalence, disability-adjusted life years rates, and mortality of CMLD in under-5 children from 1990 to 2021 in different groups, including different regions, periods, genders and socio-demographic indices (SDI), through corresponding analytical models. Overall, the global disease burden of CMLD in under-5 children has decreased from 1990 to 2021. The disease burden of CMLD in under-5 children varied significantly among different regions and countries, and there was a strong correlation between the corresponding burden of disease and the level of SDI. In addition, cross-country inequality analysis showed that while absolute inequalities in the disease burden of CMLD in under-5 children have improved, relative inequalities have worsened. It is essential to reduce the global health impact of CMLD by implementing targeted interventions to improve health care in underdeveloped areas.
Humans
;
Global Burden of Disease/trends*
;
Child, Preschool
;
Global Health/statistics & numerical data*
;
Infant
;
Male
;
Prevalence
;
Limb Deformities, Congenital/mortality*
;
Musculoskeletal Abnormalities/mortality*
;
Female
;
Disability-Adjusted Life Years
;
Incidence
;
Infant, Newborn
;
Cost of Illness
;
Socioeconomic Factors
5.Paediatric one-day admission: why and is it necessary?
Jing Zhan LOCK ; Zi Xean KHOO ; Jen Heng PEK
Singapore medical journal 2025;66(1):15-19
INTRODUCTION:
Paediatric patients admitted to the inpatient units from the emergency department (ED) are increasing, but the mean length of stay has fallen significantly. We aimed to determine the reasons behind paediatric one-day admissions in Singapore and to assess their necessity.
METHODS:
A retrospective study involving paediatric patients who were admitted from a general ED of an adult tertiary hospital to a paediatric tertiary hospital between 1 August 2018 and 30 April 2020. One-day admission was defined as an inpatient stay of less than 24 h from the time of admission to discharge. An unnecessary admission was defined as one with no diagnostic test ordered, intravenous medication administered, therapeutic procedure performed or specialty review made in the inpatient unit. Data were captured in a standardised form and analysed.
RESULTS:
There were 13,944 paediatric attendances - 1,160 (8.3%) paediatric patients were admitted. Among these, 481 (41.4%) were one-day admissions. Upper respiratory tract infection (62, 12.9%), gastroenteritis (60, 12.5%) and head injury (52, 10.8%) were the three most common conditions. The three most common reasons for ED admissions were inpatient treatment (203, 42.2%), inpatient monitoring (185, 38.5%) and inpatient diagnostic investigations (32, 12.3%). Ninety-six (20.0%) one-day admissions were unnecessary.
CONCLUSION
Paediatric one-day admissions present an opportunity to develop and implement interventions targeted at the healthcare system, the ED, the paediatric patient and their caregiver, in order to safely slow down and perhaps reverse the trend of increased hospital admissions.
Humans
;
Retrospective Studies
;
Singapore
;
Child
;
Emergency Service, Hospital/statistics & numerical data*
;
Patient Admission/statistics & numerical data*
;
Female
;
Male
;
Child, Preschool
;
Length of Stay/statistics & numerical data*
;
Infant
;
Adolescent
;
Tertiary Care Centers
;
Hospitalization/statistics & numerical data*
;
Infant, Newborn
;
Gastroenteritis/therapy*
;
Respiratory Tract Infections
6.COVID-19 vaccine acceptance among kidney transplant recipients in Singapore.
Ian Tatt LIEW ; Hanis Abdul KADIR ; Sobhana THANGARAJU ; Quan Yao HO ; Eleanor NG ; Fiona FOO ; Terence KEE
Singapore medical journal 2025;66(2):73-80
INTRODUCTION:
A successful vaccination programme forms the cornerstone of controlling coronavirus disease 2019 (COVID-19). The unprecedented speed of COVID-19 vaccine development and lack of long-term data have raised fears regarding its safety and efficacy. Vaccine hesitancy can undermine the uptake, and hence success of the vaccination programme. Given the high complication rates of COVID-19 infections in kidney transplant recipients, it is particularly important to identify and address vaccine hesitancy in this population.
METHODS:
We conducted a cross-sectional survey among kidney transplant recipients attending transplant clinic between 5 April and 5 May 2021. The survey assessed attitudes towards COVID-19, willingness/hesitancy towards COVID-19 vaccination, vaccination concerns and prompts to vaccination. This was scored on a Likert scale with scores ranging from 'strongly disagree' - 1 point to 'strongly agree' - 5 points.
RESULTS:
One hundred and one completed responses were captured. Of these, 86% respondents reported to agree or strongly agree to vaccination. This was despite significant concerns of allograft rejection (mean score 4.12, standard deviation [SD] 0.97) and decreased immunosuppressant efficacy (mean score 4.14, SD 0.96) with vaccination. Multivariable model showed a positive association with transplant vintage of ≥ 5 years (median 2.41), lower educational levels of secondary school or less (median 5.82) and healthcare provider advocacy (median 1.88) in predicting vaccine acceptance.
CONCLUSIONS
Vaccine acceptance rate was high among kidney transplant recipients. Vaccine hesitancy remains a concern in those with a transplant vintage of less than 5 years and those with tertiary educational level. Healthcare provider advocacy is important in improving vaccine acceptance rates.
Humans
;
Kidney Transplantation
;
Singapore/epidemiology*
;
Male
;
Cross-Sectional Studies
;
Female
;
COVID-19 Vaccines
;
COVID-19/epidemiology*
;
Middle Aged
;
Adult
;
Transplant Recipients/psychology*
;
Patient Acceptance of Health Care/statistics & numerical data*
;
Vaccination Hesitancy/psychology*
;
Surveys and Questionnaires
;
Vaccination/psychology*
;
Aged
;
SARS-CoV-2
7.Oncology-related emergencies discharged from the emergency department.
Si-Hua Yvonne GOH ; Juin Jie NG ; Shi-En Joanna CHAN ; Wei-Lin Tallie CHUA ; Venkataraman ANANTHARAMAN
Singapore medical journal 2025;66(2):97-101
INTRODUCTION:
Cancer patients attending emergency departments (EDs) often present with acute symptoms and are frequently admitted. This study aimed to characterise the profile of oncology patients who were discharged from the ED.
METHODS:
This was a retrospective audit of patients with cancer-related diagnoses who presented to the ED at the Singapore General Hospital (SGH) over a 6-month period from 1 October 2018 to 31 March 2019 and were directly discharged from the ED. Data was extracted from the hospital's electronic medical record system.
RESULTS:
Of the 492 participants included in the study, the majority were triaged as Priority 2 (61.4%), while 30.7% were triaged as Priority 3, 6.9% as Priority 1 and 1.0% as Priority 4. There was no statistical difference between the National Early Warning scores across the different triage categories in these patients. The most common complaint was (44.3%), followed by genitourinary symptoms (19.5%) and those related to devices, catheters or stomas (17.3%). More investigations of all types were done for patients being managed in Priority 1 (57.6%) than in the other triage categories (40.1% for Priority 2, 23.2% for Priority 3 and 12.0% for Priority 4). Treatment procedures carried out were mainly symptomatic (analgesics, antiemetics, proton pump inhibitors) for 79.8% of the patients. There were no significant differences in the proportion of patients requiring various treatment modalities among the triage categories.
CONCLUSION
Selected oncological patients may potentially be managed in an ambulatory setting.
Humans
;
Emergency Service, Hospital/statistics & numerical data*
;
Retrospective Studies
;
Female
;
Neoplasms/diagnosis*
;
Male
;
Singapore
;
Patient Discharge/statistics & numerical data*
;
Middle Aged
;
Aged
;
Triage
;
Adult
;
Emergencies
;
Aged, 80 and over
8.Association of COVID-19 'circuit breaker' with higher rates of elderly trauma admissions.
Yee Har LIEW ; Zhenghong LIU ; Mian Jie LIM ; Pei Leng CHONG ; Norhayati Bte Mohamed JAINODIN ; Teng Teng PEH ; Jing Jing CHAN ; Sachin MATHUR ; Jeremy Choon Peng WEE
Singapore medical journal 2025;66(2):91-96
INTRODUCTION:
In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) virus emerged and caused a worldwide pandemic, leading to measures being imposed by many countries to reduce its transmission. Singapore implemented the 'circuit breaker', which restricted all movements except for access to necessities and healthcare services. We aimed to investigate the impact of lockdown measures on the pattern of trauma and its effects.
METHODS:
An observational, retrospective, single-centre descriptive study was conducted using the trauma registry in Singapore General Hospital. It included patients above 18 years old who presented to the emergency department with trauma and were subsequently admitted. Patients admitted from 1 February 2020 to 31 July 2020 and those admitted during the same timeframe in 2019 were studied. Subgroup analyses were performed for patients aged ≥65 years and those <65 years.
RESULTS:
A total of 1,037 patients were included for analysis. A 17.6% increase in trauma presentations was seen from 2019 to 2020. Patients aged ≥65 years accounted for the rise in admissions. The predominant mechanism of injury was falls at home for older patients and vehicular accidents in patients <65 years. There were no significant differences in injury severity score, intensive care/high-dependency unit admission rates, length of stay, mortality rate, and subsequent need for inpatient rehabilitation.
CONCLUSION
Our study provided information on differences in trauma presentations before and during the COVID-19 pandemic. Further studies are required to better inform on additional precautionary measures needed to reduce trauma and improve safety during future lockdowns and pandemics.
Humans
;
COVID-19/prevention & control*
;
Aged
;
Retrospective Studies
;
Singapore/epidemiology*
;
Male
;
Female
;
Wounds and Injuries/epidemiology*
;
Aged, 80 and over
;
Middle Aged
;
SARS-CoV-2
;
Hospitalization/statistics & numerical data*
;
Adult
;
Emergency Service, Hospital/statistics & numerical data*
;
Registries
;
Accidental Falls/statistics & numerical data*
;
Pandemics
;
Patient Admission/statistics & numerical data*
;
Length of Stay
;
Accidents, Traffic/statistics & numerical data*
9.Disparities in ethnicity and metabolic disease burden in referrals to nephrology.
Yan Ting CHUA ; Cheang Han LEO ; Horng Ruey CHUA ; Weng Kin WONG ; Gek Cher CHAN ; Anantharaman VATHSALA ; Ye Lu Mavis GAN ; Boon Wee TEO
Singapore medical journal 2025;66(6):301-306
INTRODUCTION:
The profile of patients referred from primary to tertiary nephrology care is unclear. Ethnic Malay patients have the highest incidence and prevalence of kidney failure in Singapore. We hypothesised that there is a Malay predominance among patients referred to nephrology due to a higher burden of metabolic disease in this ethnic group.
METHODS:
This is a retrospective observational cohort study. From 2014 to 2018, a coordinator and physician triaged patients referred from primary care, and determined co-management and assignment to nephrology clinics. Key disease parameters were collated on triage and analysed.
RESULTS:
A total of 6,017 patients were studied. The mean age of patients was 64 ± 16 years. They comprised 57% men; 67% were Chinese and 22% were Malay. The proportion of Malay patients is higher than the proportion of Malays in the general population (13.4%) and they were more likely than other ethnicities to have ≥3 comorbidities, including diabetes mellitus, hypertension, hyperlipidaemia, coronary artery disease and stroke (70% vs. 57%, P < 0.001). Malay and Indian patients had poorer control of diabetes mellitus compared to other ethnicities (glycated haemoglobin 7.8% vs. 7.4%, P < 0.001). Higher proportion of Malay patients compared to other ethnicities had worse kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m 2 on presentation (28% vs. 24%, P = 0.003). More ethnic Malay, Indian and younger patients missed appointments.
CONCLUSION
A disproportionately large number of Malay patients are referred for kidney disease. These patients have higher metabolic disease burden, tend to miss appointments and are referred at lower eGFR. Reasons underpinning these associations should be identified to facilitate efforts for targeting this at-risk population, ensuring kidney health for all.
Humans
;
Male
;
Female
;
Retrospective Studies
;
Middle Aged
;
Singapore/epidemiology*
;
Referral and Consultation/statistics & numerical data*
;
Aged
;
Nephrology
;
Glomerular Filtration Rate
;
Metabolic Diseases/epidemiology*
;
Ethnicity
;
Diabetes Mellitus/epidemiology*
;
Malaysia/ethnology*
;
Adult
10.Mental health-related presentations to a tertiary emergency department during the COVID-19 pandemic.
Elijah Gin LIM ; Ashley Ern Hui HOW ; Julian Zhong Hui LEE ; Sameera GANTI ; Eunizar OMAR
Singapore medical journal 2025;66(12):645-650
INTRODUCTION:
The coronavirus disease 2019 (COVID-19) pandemic has caused significant mental distress in populations globally. At the frontline of the pandemic, emergency departments (EDs) are the prime setting to observe the effects of the pandemic on the mental health of the population. We aimed to describe the trend of mental health-related ED attendances at an acute hospital in Singapore before and during the various stages of the COVID-19 pandemic.
METHODS:
This is a retrospective, descriptive study of patients who presented to the ED between 1 January 2019 and 31 December 2020. Patients diagnosed with mental health-related systematised nomenclature of medicine who visited the ED during this period were identified and were placed into mental health diagnosis categories for analysis. A comparison was made between patients who presented before the pandemic (2019) and during the pandemic (2020).
RESULTS:
During the study periods, we identified 1,421 patients, of whom 27 were excluded due to non-mental health-related diagnoses, leaving 1,394 patients for analysis. There was a 36.7% increase in mental health-related ED presentations from 2019 to 2020. The proportion of higher-acuity mental health-related ED attendances and number of suicide attempts also increased.
CONCLUSION
Our study described an increase in the proportion of high-acuity mental health-related ED attendances during the COVID-19 pandemic. Emergency physicians must be cognisant of the effects of the pandemic on mental health. Further research should be conducted to better equip the healthcare system for handling all aspects of the pandemic.
Humans
;
COVID-19/psychology*
;
Emergency Service, Hospital/statistics & numerical data*
;
Retrospective Studies
;
Singapore/epidemiology*
;
Male
;
Female
;
Adult
;
Middle Aged
;
Mental Disorders/diagnosis*
;
Mental Health
;
SARS-CoV-2
;
Tertiary Care Centers
;
Pandemics
;
Aged
;
Suicide, Attempted/statistics & numerical data*
;
Young Adult
;
Adolescent

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