BACKGROUND AND OBJECTIVE

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as the causative agent of COVID-19 has significantly challenged the public health landscape in late 2019. After almost 3 years of the first ever SARS-CoV-2 case, the World Health Organization (WHO) declared the end of this global health emergency in May 2023. Although, despite the subsequent drop of COVID-19 cases, the SARS-CoV-2 infection still exhibited multiple waves of infection, primarily attributed to the appearance of new variants. Five of these variants have been classified as Variants of Concern (VOC): Alpha, Beta, Gamma, Delta, and the most recent, Omicron. Therefore, the development of methods for the timely and accurate detection of viral variants remains fundamental, ensuring an ongoing and effective response to the disease. This study aims to evaluate the feasibility of the application of an in-house approach in genomic surveillance for the detection of SARS-CoV-2 variants using in silico designed primers.

METHODS

The primers used for the study were particularly designed based on conserved regions of certain genes in the virus, targeting distinct mutations found in known variants of SARS-CoV-2. Viral RNA extracts from nasopharyngeal samples (n=14) were subjected to quantitative and qualitative tests (Nanodrop and AGE). Selected samples were then analyzed by RT-PCR and amplicons were submitted for sequencing. Sequence alignment analysis was carried out to identify the prevailing COVID-19 variant present in the sample population.

RESULTS

The study findings demonstrated that the in-house method was able to successfully amplify conserved sequences (spike, envelope, membrane, ORF1ab) and enabled identification of the circulating SARS-CoV-2 variant among the samples. Majority of the samples were identified as Omicron variant. Three out of four designed primers effectively bound into the conserved sequence of target genes present in the sample, revealing the specific SARSCoV-2 variant. The detected mutations characterized for Omicron found in the identified lineages included K417N, S477N, and P681H which were also identified as mutations of interest. Furthermore, identification of the B.1.448 lineage which was not classified in any known variant also provided the potential of the developed in-house method in detecting unknown variants of COVID-19.

CONCLUSION

Among the five VOCs, Omicron is the most prevalent and dominant variant. The in-house direct PCR product sequencing surveillance (DPPSS) method provided an alternative platform for SAR-CoV-2 variant analysis which is accessible and affordable than the conventional diagnostic surveillance methods and the whole genome sequencing. Further evaluation and improvements on the oligonucleotide primers may offer significant contribution to the development of a specific and direct PCRbased detection of new emerging COVID-19 variants.

Sars-cov-2 ; Polymerase Chain Reaction ; Dna Primers ; Oligonucleotide Primers ; Computer Simulation ; Conserved Sequence ; Coronavirus ; Covid-19 ; Disease ; Emergencies ; Evaluation Studies As Topic ; Genes ; Genome ; Global Health ; Health ; Identification (psychology) ; Infection ; Infections ; Membranes ; Methods ; Mutation ; Oligonucleotides ; Organizations ; Population ; Public Health ; Rna ; Rna, Viral ; Sars Virus ; Sequence Alignment ; Severe Acute Respiratory Syndrome ; Syndrome ; Viruses ; Whole Genome Sequencing ; World Health Organization

Walking through the wards of a crowded public hospital and seeing suffering and tragedy from easily preventable conditionsmakes one wonder what it takes for a facility to change the outcomes. The evidence is there, and guidelines have beendeveloped from it; yet practices remain difficult to change—whether in screening, prevention, treatment, or rehabilitation.

Recently, the Department of Health has put up a compendium of clinical practice guidelines (CPG) crafted accordingto the standards set by the Manual for Clinical Practice Guideline Development of DOH-Philhealth.Guidelines stipulatethat dissemination and implementation be considered, and applicability issues are discussed. The uptake of the guidelinesshould be evaluated, and facilitators and barriers should be identified. Thus, there is a need for implementation andapplicability studies to assess how effective guidelines are. For breast cancer, the Philippine Guidelines were published in 2022and updated in 2026.Identified as barriers against implementation are financial constraints and out-of-pocket costs. Actahas since responded to these concerns by publishing articles on financing cost assessment, and in this issue, by Mondragonand co-authors, an “Assessment of Out-of-Pocket Expenditure of HER2-Positive Breast Cancer Patients in a Tertiary CancerCenter and Private Clinics in the Philippines.”

These types of studies are necessary in the translation of evidence to practice, allowing organizations to adopt, scale,and sustain recommendations to real-world settings.

Where CPGs on malnutrition cite resource constraints as the only significant barrier for implementation, the article byde Luna and co-authors on the “A Qualitative Program Evaluation Study on the Perceived Impact of Health and NutritionPrograms among Beneficiaries of a Civil Society Organization in the Philippines” in this issue of the Acta add fear ofsustainability by families and competition from readily accessible instant food of poor nutritional value as barriers in implementingsuch programs.

These studies help us go beyond information dissemination of evidence-based practice to create pathways for impactfulintegration of recommended interventions. Implementation studies sharpen our analysis and focus our efforts on strategies thatcan help pilot, roll out, and scale up guidelines.

New modalities to carry out recommendations can also be part of how guidelines are implemented in the communitysetting. Where the Philippine Academy of Rehabilitation Medicine (PARM) recommends early home-based rehabilitation,the Stroke Society of the Philippines recommends telerehabilitation to augment the efforts of care providers.The articleby Laxamana and co-authors in this issue on “The Acceptance of Stroke Telerehabilitation among Rehabilitation Providersand Consumers in Two Tertiary Hospitals in the Philippines” not only identifies but also provides suggestions to addressimplementation barriers.

We support and encourage articles on implementation science. These works provide tools to convert evidence into outcomes.These transform organizations and help us accomplish meaningful, lasting structural change that should come withoutany delay to provide relief to our patients in our crowded public wards.

Practice Guideline ; Program Evaluation ; Evaluation Studies As Topic ; Costs And Cost Analysis ; Organizations ; Residence Characteristics ; Health Services Needs And Demand

BACKGROUND

The global impact of the COVID-19 pandemic has instigated a profound public health crisis, particularly affecting professionals like dentists who, due to their close interaction with saliva—a potential viral reservoir—and the aerosols generated during specific procedures, face elevated risks of infection. To mitigate this, the Centers for Disease Control and Prevention (CDC) and the Philippine Dental Association (PDA) have established guidelines for averting cross-infection in dental settings

OBJECTIVE

This study, conducted in an urbanized Metro Manila City, delves into the infection control practices of dentists amid the pandemic.

METHODS

Dentists from a Metro Manila city dental chapter were invited to participate in an online survey (Google Forms) consisting of participants' demographics, patient triage, engineering, administrative controls, disinfection personal hygiene, personal protective equipment (PPE), and waste management practices. Descriptive statistics, employing frequency distributions and percentages, summarized the dentists' adherence to infection control protocols.

RESULTS

Out of forty-nine respondents (49), the majority (92%) provided their teams' orientation on COVID-19 infection control protocols before reopening. Notably, 57% deferred elective procedures and 43% postponed aerosolgenerating procedures (AGPs). Only 39% utilized rubber dam isolation during AGPs. Most respondents reported full implementation of recommended administrative controls during the pandemic, with 92% isolating their treatment areas from other parts of the clinic. Most respondents adopted high-efficiency particulate air (HEPA) filtration units (82%) as one of their clinic’s engineering controls, and an extraoral vacuum machine, accounting for 71% of the respondents. The most common disinfection product used by the participants was alcohol, which was at 94%. Additionally, over 90% adhered to all recommended hand hygiene practices for both dental staff and patients. For the waste management protocols, only 55% of the respondents have their infectious waste collected by third-party Treatment Storage and Disposal (TSD) facilities.

CONCLUSION

The data shows that with the guidelines posted by both the PDA and CDC, the city’s dental practitioners could still provide services to the community in the safest manner at the time by being updated and following the infection control practices suggested by both organizations. Although some areas could have been improved, such as third-party waste management and the utilization of RT-PCR testing, some of these problems could have been attributed to the lack of availability in their areas.

Public Health ; Philippines ; Interprofessional Education ; World Health Organization ; Centers For Disease Control And Prevention, U.s. ; Centers For Disease Control And Prevention (u.s.)

BACKGROUND

The global impact of the COVID-19 pandemic has instigated a profound public health crisis, particularly affecting professionals like dentists who, due to their close interaction with saliva—a potential viral reservoir—and the aerosols generated during specific procedures, face elevated risks of infection. To mitigate this, the Centers for Disease Control and Prevention (CDC) and the Philippine Dental Association (PDA) have established guidelines for averting cross-infection in dental settings.

OBJECTIVE

This study, conducted in an urbanized Metro Manila City, delves into the infection control practices of dentists amid the pandemic.

METHODS

Dentists from a Metro Manila city dental chapter were invited to participate in an online survey (Google Forms) consisting of participants' demographics, patient triage, engineering, administrative controls, disinfection personal hygiene, personal protective equipment (PPE), and waste management practices. Descriptive statistics, employing frequency distributions and percentages, summarized the dentists' adherence to infection control protocols.

RESULTS

Out of forty-nine respondents (49), the majority (92%) provided their teams' orientation on COVID-19 infection control protocols before reopening. Notably, 57% deferred elective procedures and 43% postponed aerosolgenerating procedures (AGPs). Only 39% utilized rubber dam isolation during AGPs. Most respondents reported full implementation of recommended administrative controls during the pandemic, with 92% isolating their treatment areas from other parts of the clinic. Most respondents adopted high-efficiency particulate air (HEPA) filtration units (82%) as one of their clinic’s engineering controls, and an extraoral vacuum machine, accounting for 71% of the respondents. The most common disinfection product used by the participants was alcohol, which was at 94%. Additionally, over 90% adhered to all recommended hand hygiene practices for both dental staff and patients. For the waste management protocols, only 55% of the respondents have their infectious waste collected by third-party Treatment Storage and Disposal (TSD) facilities.

CONCLUSION

The data shows that with the guidelines posted by both the PDA and CDC, the city’s dental practitioners could still provide services to the community in the safest manner at the time by being updated and following the infection control practices suggested by both organizations. Although some areas could have been improved, such as third-party waste management and the utilization of RT-PCR testing, some of these problems could have been attributed to the lack of availability in their areas.

Human ; Male ; Female ; Adult: 25-44 Yrs Old ; Middle Aged: 45-64 Yrs Old ; Aged: 65-79 Yrs Old ; World Health Organization ; Residence Characteristics ; Quarantine ; Public Health ; Centers For Disease Control And Prevention (u.s.) ; Covid-19 ; Centers For Disease Control And Prevention, U.s.

In recognition of the morbidity and mortality associated with human immunodeficiency virus (HIV), the Joint United Nations Programme on HIV/acquired immunodeficiency syndrome (AIDS) (UNAIDS) aims to end the epidemic by setting and striving to achieve the ambitious 95-95-95 targets. However, Singapore is still not performing well in the first UNAIDS target. The National HIV Programme (NHIVP) developed this set of recommendations based on an adaptation of major international guidelines from the World Health Organization and the US Centers for Disease Control and Prevention. The goals of this recommendation are: (1) to increase the uptake of HIV testing; (2) to allow earlier detection and identification of individuals with unrecognised HIV infection; (3) to facilitate linkage to clinical services; and (4) reduce further transmission of HIV infection in Singapore.
Humans ; Singapore/epidemiology* ; HIV Infections/epidemiology* ; United States ; HIV Testing ; Mass Screening ; World Health Organization ; Practice Guidelines as Topic ; Centers for Disease Control and Prevention, U.S. ; National Health Programs

Signal detection is a critical task in drug safety regulation. However, it inevitably generates irrelevant or false signals, posing challenges for resource allocation by marketing authorization holders. To reasonably assess these signals, different countries have established various principles for prioritizing the evaluation of risk signals. This study systematically compares these principles and finds that the U.S. Food and Drug Administration(FDA) focuses on practical issues, such as identifying drug confusion or drug interactions. However, China's Good Pharmacovigilance Practices and the European Medicines Agency(EMA) emphasize a comprehensive evaluation framework. The Council for International Organizations of Medical Sciences(CIOMS) emphasizes the consistency of multiple data sources, highlighting the reliability of signal evaluation. China practices a multidisciplinary approach combining traditional Chinese and western medicine, and the risk signals related to traditional Chinese medicine(TCM) have unique characteristics, including complex components, cumulative toxicity, specific theoretical foundations, and drug interactions. The different priorities in risk signal evaluation principles across countries suggest that China should strengthen clinical trial research, emphasize corroboration with evidence of multiple sources, and pay particular attention to the risks of drug interactions in the TCM regulatory science. Establishing the risk signal prioritization principles that align with the characteristics of TCM enables more precise and efficient scientific regulation of TCM.
Humans ; Medicine, Chinese Traditional/standards* ; China ; Drugs, Chinese Herbal/adverse effects* ; United States ; United States Food and Drug Administration

Primary malignant bone tumors are extremely rare. Osteosarcoma, chondrosarcoma, Ewing's sarcoma, and myeloma are the most common malignancy in bone. Osteosarcoma and Ewing's sarcoma are common in children and adolescents, and the tumors are high lethality due to the high rate of pulmonary metastasis. While chondrosarcoma, myeloma, and chordoma are more common in middle aged and elderly people. Japanese Orthopaedic Association (JOA) published the secondary clinical practice guideline on the management of primary malignant bone tumors. We put an emphasis on explanation some important issue of this guideline for help Chinese musculoskeletal tumor professionals in clinical practice.
Humans ; Bone Neoplasms/surgery* ; Chondrosarcoma/therapy* ; Japan ; Orthopedics ; Osteosarcoma/pathology* ; Practice Guidelines as Topic ; Sarcoma, Ewing/therapy* ; Societies, Medical

Hallux rigidus is the most common type of foot degenerative arthritis. With the aging of the population and the increasing demand for exercise, its incidence rate continues to rise. In October 2024, the American College of Foot and Ankle Surgeon (ACFAS) published 24 clinical consensus statements in the Journal of Foot & Ankle Surgery. The latest expert opinions are formed around hallux rigidus assessment, classification, conservative treatment, surgical indications, surgical method selection. Combined with the characteristics of Chinese patients and the current clinical situation, this article interprets and analyzes the key points of the consensus, and proposes individualized surgical plans for joint preservation, with the aim of providing evidence-based basis and decision-making reference for colleagues in domestic foot and ankle surgery.
Humans ; Hallux Rigidus/diagnosis* ; Consensus ; United States ; Foot/surgery* ; Ankle/surgery* ; Societies, Medical

Brain-computer interface (BCI) technology is an innovative and cutting-edge medical advancement that enables direct interaction between the brain and external devices, facilitating the reconstruction of daily functions for patients or serving as a method for neuro-regulation therapy. Although this technology offers a broad range of clinical applications, there are problems as potential risks, individual variations, and the need for long-term monitoring of its effects during utilization. Consequently, the comprehensive evaluation of its safety and effectiveness poses a considerable challenge for regulatory agencies. This study provides a concise introduction to the development history and various types of BCI technology, followed by a summary of the regulatory situation for different types of BCI medical devices in the United States. Furthermore, the regulatory requirements imposed by the US FDA on this product category are analyzed. Finally, the article concludes by presenting a summary and future perspective on the current development of BCI technology, with the aim of offering beneficial insights and guidance for the regulation of BCI medical devices.
Brain-Computer Interfaces ; United States ; United States Food and Drug Administration ; Humans ; Electroencephalography

In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes using real-world data can provide important evidence for regulatory decisions. A total of 90 instances of publicly released on the application of real-world evidence to support regulatory decisions of U. S. Food and Drug Administration are explored, and the positioning and value of real-world evidence in U. S. Food and Drug Administration regulatory decisions are summarized and analyzed, providing references for the use of real-world data and real-world evidence to promote medical devices whole cycle regulation in China.
United States ; United States Food and Drug Administration ; Equipment and Supplies ; Device Approval ; China