METHODS: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials.
RESULTS: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing.
CONCLUSION: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies.
OBJECTIVE: This paper aimed to describe the development process of the COVID-19 Symptom Monitoring System (CoSMoS), which consists of a self-monitoring, algorithm-based Telegram bot and a teleconsultation system. We describe all the essential steps from the clinical perspective and our technical approach in designing, developing, and integrating the system into clinical practice during the COVID-19 pandemic as well as lessons learned from this development process.
METHODS: CoSMoS was developed in three phases: (1) requirement formation to identify clinical problems and to draft the clinical algorithm, (2) development testing iteration using the agile software development method, and (3) integration into clinical practice to design an effective clinical workflow using repeated simulations and role-playing.
RESULTS: We completed the development of CoSMoS in 19 days. In Phase 1 (ie, requirement formation), we identified three main functions: a daily automated reminder system for patients to self-check their symptoms, a safe patient risk assessment to guide patients in clinical decision making, and an active telemonitoring system with real-time phone consultations. The system architecture of CoSMoS involved five components: Telegram instant messaging, a clinician dashboard, system administration (ie, back end), a database, and development and operations infrastructure. The integration of CoSMoS into clinical practice involved the consideration of COVID-19 infectivity and patient safety.
CONCLUSIONS: This study demonstrated that developing a COVID-19 symptom monitoring system within a short time during a pandemic is feasible using the agile development method. Time factors and communication between the technical and clinical teams were the main challenges in the development process. The development process and lessons learned from this study can guide the future development of digital monitoring systems during the next pandemic, especially in developing countries.
METHODS: A systematic review using searches in PubMed, SCOPUS and ISI Web of Knowledge databases was conducted in August 2017 and updated between January and May 2020. The review was registered at the PROSPERO database number CRD42017070153. PA publications per 100,000 inhabitants per country was the main variable of interest. Descriptive and time-trend analyses were conducted in STATA version 16.0.
RESULTS: The search retrieved 555,468 articles of which 75,756 were duplicates, leaving 479,712 eligible articles. After reviewing inclusion and exclusion criteria, 23,860 were eligible for data extraction. Eighty-one percent of countries (n = 176) had at least one PA publication. The overall worldwide publication rate in the PA field was 0.46 articles per 100,000 inhabitants. Europe had the highest rate (1.44 articles per 100,000 inhabitants) and South East Asia had the lowest (0.04 articles per 100,000 inhabitants). A more than a 50-fold difference in publications per 100,000 inhabitants was identified between high and low-income countries. The least productive and poorest regions have rates resembling previous decades of the most productive and the richest.
CONCLUSION: This study showed an increasing number of publications over the last 60 years with a growing number of disciplines and research methods over time. However, striking inequities were revealed and the knowledge gap across geographic regions and by country income groups was substantial over time. The need for regular global surveillance of PA research, particularly in countries with the largest data gaps is clear. A focus on the public health impact and global equity of research will be an important contribution to making the world more active.
OBJECTIVES: To study the trends in sex and gender differences in ACS using the Malaysian NCVD-ACS Registry.
METHODS: Data from 24 hospitals involving 35,232 ACS patients (79.44% men and 20.56% women) from 1st. Jan 2012 to 31st. Dec 2016 were analysed. Data were collected on demographic characteristics, coronary risk factors, anthropometrics, treatments and outcomes. Analyses were done for ACS as a whole and separately for ST-segment elevation myocardial infarction (STEMI), Non-STEMI and unstable angina. These were then compared to published data from March 2006 to February 2010 which included 13,591 ACS patients (75.8% men and 24.2% women).
RESULTS: Women were older and more likely to have diabetes mellitus, hypertension, dyslipidemia, previous heart failure and renal failure than men. Women remained less likely to receive aspirin, beta-blocker, angiotensin-converting enzyme inhibitor (ACE-I) and statin. Women were less likely to undergo angiography and percutaneous coronary intervention (PCI) despite an overall increase. In the STEMI cohort, despite a marked increase in presentation with Killip class IV, women were less likely to received primary PCI or fibrinolysis and had longer median door-to-needle and door-to-balloon time compared to men, although these had improved. Women had higher unadjusted in-hospital, 30-Day and 1-year mortality rates compared to men for the STEMI and NSTEMI cohorts. After multivariate adjustments, 1-year mortality remained significantly higher for women with STEMI (adjusted OR: 1.31 (1.09-1.57), p<0.003) but were no longer significant for NSTEMI cohort.
CONCLUSION: Women continued to have longer system delays, receive less aggressive pharmacotherapies and invasive treatments with poorer outcome. There is an urgent need for increased effort from all stakeholders if we are to narrow this gap.
METHODS: This is a cross-sectional descriptive study that was conducted to evaluate perception and experience of pharmacists with the use of Internet-based medication information by their patients. During the study period, 200 pharmacists were approached to participate in the study using a paper-based survey to assess their perceptions and current experience with the use of Internet-based medication information by their patients. Data were analyzed using descriptive statistics (mean/standard deviation for continuous variables, and frequency/percentages for qualitative variables). Also, simple linear regression was utilized to screen factors affecting pharmacists' perception scores of the use of Internet-based medication information.
RESULTS: Among 161 recruited pharmacists, the majority (n = 129, 80.1%) reported receiving inquiries from patients about Internet-based medication information within the last year. Among them, only 22.6% (n = 29) of pharmacists believed that Internet-based medication information is somewhat or very accurate. Unfortunately, only 24.2% (n = 31) of them stated that they always had enough time for their patient to discuss their Internet-based medication information. Regarding pharmacists' perception of the use of Internet-based medication information by their patients, more than half of the pharmacists (>50%) believe that Internet-based medication information could increase the patient's role in taking responsibility. On the other hand, 54.7% (n = 88) of the pharmacists believed that Internet-based medication information would contribute to rising the healthcare cost by obtaining unnecessary medications by patients. Finally, pharmacists' educational level was found to significantly affect their perception scores toward patient use of Internet-based medication information where those with higher educational level showed lower perception score (r = -0.200, P-value = 0.011).
CONCLUSION: Although pharmacists felt that usage of Internet-based data by patients is beneficial, they also have believed that it has a negative impact in terms of rising the healthcare cost, and it promotes unnecessary fear or concern about medications. We suggest that pharmacists be trained on principles of critical appraisal to become professional in retrieval information on the Internet that might improve their delivery of healthcare information and their recommendations to patients.
Methods: The articles were identified through a search on Web of Science (WoS), property of Clarivate Analytics database published on endodontic microbiology. The citation information of the selected articles was recorded. The Journal of Endodontics, International Endodontic Journal, Oral Surgery Oral Medicine Oral Pathology Oral Radiology and Endodontology, Dental Traumatology, and Australian Endodontic Journal were searched in the search title. Descriptive and bivariate analyses were performed using a statistical software package SPSS. Statistical analysis was performed using Shapiro-Wilk, Kruskal-Wallis, Post hoc, Mann-Kendall trend, and Spearman-rank tests.
Results: The 50 most cited articles were published from 1965 to 2012 with citation count varying from 1065 to 103 times. The total citation counts of articles recorded were 11,525 (WoS), 12,602 (Elseviers' Scopus), and 28,871 (Google Scholar). The most prolific years in terms of publications were 2001, 2002, and 2003, with five publications each, followed by 2005 with four. The year with most citations was 1998, with 1,330 citations, followed by 1965 and 2001, with 1,065 and 1,015 citations, respectively. A total of 136 authors contributed to the top 50 most cited articles with 27 corresponding institutions from 12 different countries. The most common methodological design was in vitro study, followed by clinic-laboratory study, literature review, systematic review and meta-analysis, and animal study.
Conclusions: The present study provided a detailed list of the top 50 most cited and classic articles on microbiology in endodontics. This will help researchers, students, and clinicians in the field of endodontics as an impressive source of information.
METHODS: This was a data review involving children aged
METHODS: The ADR reports recorded between 2000 and 2017 were retrospectively analysed to identify hepatic ADR reports. The trend and characteristics of hepatic ADR cases were described. Multivariate disproportionality analysis of the causative agents was performed to generate signals of hepatic ADRs.
RESULTS: A total of 2090 hepatic ADRs (1.77% of all ADRs) were reported with mortality rate of 12.7% among cases with known clinical outcomes. The incidence of hepatic ADR reporting in Malaysia increased significantly over 18 years from 0.26 to 9.45 per million population (P
OBJECTIVE: This paper presents a rescue framework for the transfusion of the best CP to the most critical patients with COVID-19 on the basis of biological requirements by using machine learning and novel MCDM methods.
METHOD: The proposed framework is illustrated on the basis of two distinct and consecutive phases (i.e. testing and development). In testing, ABO compatibility is assessed after classifying donors into the four blood types, namely, A, B, AB and O, to indicate the suitability and safety of plasma for administration in order to refine the CP tested list repository. The development phase includes patient and donor sides. In the patient side, prioritisation is performed using a contracted patient decision matrix constructed between 'serological/protein biomarkers and the ratio of the partial pressure of oxygen in arterial blood to fractional inspired oxygen criteria' and 'patient list based on novel MCDM method known as subjective and objective decision by opinion score method'. Then, the patients with the most urgent need are classified into the four blood types and matched with a tested CP list from the test phase in the donor side. Thereafter, the prioritisation of CP tested list is performed using the contracted CP decision matrix.
RESULT: An intelligence-integrated concept is proposed to identify the most appropriate CP for corresponding prioritised patients with COVID-19 to help doctors hasten treatments.
DISCUSSION: The proposed framework implies the benefits of providing effective care and prevention of the extremely rapidly spreading COVID-19 from affecting patients and the medical sector.