1.Current management status of real-world studies in medical institutions in China
Ziqi PAN ; Hong FANG ; Jingting DU ; Huiyao HUANG ; Yang XIE ; Angela YIN ; Ning LI ; Siyan ZHAN
Chinese Journal of Epidemiology 2025;46(7):1255-1261
Objective:To analyze the current management status of real-world studies (RWS) in the medical institutions in China and suggest improvement focus for the management optimization.Methods:Surveys were conducted in 81 medical institutions nationwide. Convenience sampling was used to recruit survey subjects, and data were collected through self-administered questionnaires, followed by statistical analysis using descriptive methods.Results:The survey results indicated that 92.6% (75/81) of the medical institutions surveyed had undertaken RWS projects, with electronic medical records being the primary data source (89.3%, 67/75). Retrospective and prospective observational studies were the main types of study designs. Additionally, 96.3% (78/81) of the research subjects indicated that their medical institution expressed willingness to participate in or undertake RWS projects in the future. In terms of management, all types of RWS projects were managed by clinical trial center (24.0, 18/75), but differences existed in the management practices among medical institutions. Moreover, the challenges in data quality and standardization, study design and staff training, data and privacy protection and information technology support appeared in the management of RWS projects.Conclusions:It suggests to optimize the management processes of RWS projects in medical institutions and improve relevant laws and regulations to promote the development of RWS in China.
2.Current management status of real-world studies in medical institutions in China
Ziqi PAN ; Hong FANG ; Jingting DU ; Huiyao HUANG ; Yang XIE ; Angela YIN ; Ning LI ; Siyan ZHAN
Chinese Journal of Epidemiology 2025;46(7):1255-1261
Objective:To analyze the current management status of real-world studies (RWS) in the medical institutions in China and suggest improvement focus for the management optimization.Methods:Surveys were conducted in 81 medical institutions nationwide. Convenience sampling was used to recruit survey subjects, and data were collected through self-administered questionnaires, followed by statistical analysis using descriptive methods.Results:The survey results indicated that 92.6% (75/81) of the medical institutions surveyed had undertaken RWS projects, with electronic medical records being the primary data source (89.3%, 67/75). Retrospective and prospective observational studies were the main types of study designs. Additionally, 96.3% (78/81) of the research subjects indicated that their medical institution expressed willingness to participate in or undertake RWS projects in the future. In terms of management, all types of RWS projects were managed by clinical trial center (24.0, 18/75), but differences existed in the management practices among medical institutions. Moreover, the challenges in data quality and standardization, study design and staff training, data and privacy protection and information technology support appeared in the management of RWS projects.Conclusions:It suggests to optimize the management processes of RWS projects in medical institutions and improve relevant laws and regulations to promote the development of RWS in China.
3.Effect of Dietary Challenges on the Flexural Properties of Resin-based Composites
Noor Azlin Yahya ; Lim Shi Yin ; Maria Angela Garcia Gonzalez
Annals of Dentistry 2021;28(1):52-60
This study aims to compare flexural strength and flexural modulus of different resin-based composites (RBCs) and to determine the impact of dietary solvents on flexural properties. Forty specimens (12x2x2mm) for each of two conventional (Aura Easy [AE]; Harmonize [HN]) and one bulk fill (Sonic Fill 2 [SF2]) were fabricated using customised plastic moulds. Specimens were light-cured, measured and randomly divided into four groups. The groups (n=10) were conditioned for 7 days at 37°C: in one of media: air (control), artificial saliva (SAGF), 0.02N citric acid and 50% ethanol–water solution. After conditioning, the specimens subjected to flexural testing. Two-way ANOVA and one-way ANOVA (post hoc: Tukey’s or Dunnett T3 tests) were used at =0.05. Significant differences in flexural properties were observed between materials and conditioning media. Flexural strength and modulus values ranged from 124.85MPa to 51.25MPa; and 6.76GPa to 4.03GPa, respectively. The highest flexural properties were obtained with conditioning in air. Exposure to aqueous solutions generally reduced flexural properties. In conclusion, the effect of dietary solvents on flexural properties were material and medium dependent. For functional longevity of restorations, patients’ alcohol intake should be considered during material selection. Dietary advice (reduce alcohol consumption) should be given to patients post operatively.
4.Quality of Life and Tendency to Aggression Among Relapsed and First Time Substance Abusers: A Comparative Assessment Study
Angela Shalini Muneeswaran ; Sohayla M. Attalla ; Eva Tan Lee Yin
Malaysian Journal of Medicine and Health Sciences 2020;16(Supp 1,January):19-23
Introduction: Drug abuse is a prevalent issue in Malaysia, and a constant struggle to eradicate even among substance abusers who have received prior rehabilitation. Drug abuse has also been known to affect the quality of life of an individual, due to the stigma it carries. This research emphasized on studying the life quality of relapsed and first-time substance abusers in rehabilitation centres including their tendency towards aggression. Methods: A cross-sectional study was conducted to evaluate the current inpatients in Cure & Care Rehabilitation Centres (CCRC) in Peninsular Malaysia. Primary data was acquired using a self-administered questionnaire consisting of socio-demographic (Part A), quality of life (Part B) and aggression related questions (Part C). 417 individuals were selected through purposive sampling from five different centres. A statistical analysis was conducted using independent t-test, single linear regression and Kruskal-Wallis using SPSS version 25.0. Results: An analysis of the data presented no significant association between quality of life and tendency of aggression among relapsed and first time substance abusers (p>0.05). Based on the analysis and the outcome, age influences the level of aggression (p=0.018) while quality of life is affected by education level (p=0.017). Marital status is a factor that affects both the level of aggression (p=0.015) and quality of life (p=0.043). Conclusion: The findings may contribute to law enforcements in reducing violent crimes committed by drug abusers and rehabilitation efforts by rehabilitation centres, by establishing demographic profiles in relation to quality of life and aggression.
6.Synchronous papillary thyroid carcinoma and medullary thyroid carcinoma – a pitfall waiting to happen
Tang Po Yin ; Khor Li Yan ; Angela Takano
The Malaysian Journal of Pathology 2017;39(2):171-174
Papillary thyroid carcinoma (PTC) is the most common thyroid carcinoma and is derived from
thyroid follicular cells. In contrast, medullary thyroid carcinoma (MTC) is rare and originates
from the parafollicular C-cells. Synchronous occurrence of these two carcinomas is uncommon and
occurs as either discrete lesions or as a mixed lesion. The current case report describes a 50-year-old
woman with synchronous multiple discrete MTC and PTC with lymph nodes metastasis. Pathologists
and treating physicians should be aware of the synchronous coexistence of these entities to avoid
possible misdiagnosis.
7.Analysis of Lyso-Globotriaosylsphingosine in Dried Blood Spots.
Britt JOHNSON ; Hermann MASCHER ; Daniel MASCHER ; Elisa LEGNINI ; Christina Y HUNG ; Angela DAJNOKI ; Yin Hsiu CHIEN ; Laszlo MARODI ; Wuh Liang HWU ; Olaf A BODAMER
Annals of Laboratory Medicine 2013;33(4):274-278
Recently, lyso-globotriaosylsphingosine (lyso-Gb3) was found to be elevated in plasma of treatment naive male patients and some female patients with Fabry Disease (FD). This study tested whether lyso-Gb3 could be analyzed in dried blood spots (DBS) from filter cards and whether concentrations are elevated in newborn infants with FD. Lyso-Gb3 concentrations were analyzed in DBS following extraction using a novel HPLC-mass spectrometry (MS)/MS method. Lyso-Gb3 levels in DBS were above the lower limit of quantitation (0.28 ng/mL) in 5/17 newborn FD infants (16 males; range: 1.02-8.81 ng/mL), but in none of the newborn controls, in all 13 patients (4 males) with classic FD (range: 2.06-54.1 ng/mL), in 125/159 Taiwanese individuals with symptomatic or asymptomatic FD who carry the late onset alpha-galactosidase A (GLA) mutation c.936+919G>A (IVS4+919G>A) (3.75+/-0.69 ng/mL; range: 0.418-3.97 ng/mL) and in 20/29 healthy controls (0.77+/-0.24 ng/mL; range: 0.507-1.4 ng/mL). The HPLC-MS/MS method for analysis of lyso-Gb3 is robust and yields reproducible results in DBS in patients with FD. However, concentrations of lyso-Gb3 were below the limit of quantitation in most newborn infants with FD rendering this approach not suitable for newborn screening. In addition, most females with the late onset mutation have undetectable lyso-Gb3 concentrations.
Adolescent
;
Adult
;
Blood Chemical Analysis/*methods
;
Child
;
Chromatography, High Pressure Liquid
;
*Dried Blood Spot Testing
;
Fabry Disease/blood/diagnosis
;
Female
;
Glycolipids/*blood
;
Humans
;
Infant, Newborn
;
Male
;
Sphingolipids/*blood
;
Tandem Mass Spectrometry
;
Young Adult


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