BACKGROUND AND OBJECTIVE

Randomized controlled trials (RCTs) are essential for advancing evidence-based healthcare by evaluating the effectiveness and safety of health interventions. Despite the increasing recognition of clinical research, the Philippines has had limited contributions to global RCT output. This bibliometric analysis aims to assess the trends, characteristics, and impact of RCTs conducted in the Philippines and published online.

A systematic search of Medline (PubMed), and EMBASE, along with Acta Medica Philippina, was conducted to identify published RCTs from January 1990 to October 2022. Eligible studies were screened and analyzed based on publication trends, funding sources, study designs, research settings, and institutional contributions. Descriptive statistics were used to summarize key findings.

A total of 391 RCTs were identified, with a notable increase in number of RCTs published over time. Most studies (91.8%) were published in international journals, and funding was primarily sourced from pharmaceutical companies (47.1%). The predominant RCT design was two-arm parallel (64.7%), with hospitals being the most common research setting (54.2%). Research areas were led by infectious diseases, particularly vaccine-preventable illnesses (23.8%). While the University of the Philippines Manila (21.1%) and the Research Institute for Tropical Medicine (13.7%) were the leading institutions in terms of highest number of published RCTs, foreign authors accounted for nearly half (47.3%) of primary authorships. The most cited studies focused on cardiovascular diseases, infectious diseases, and oncology.

The increasing number of published RCTs in the Philippines reflects growth in research capacity and institutional engagement. Strengthening national research dissemination platforms and fostering regional collaborations will be essential in advancing the Philippines’ contribution to global clinical research.

The International Severe Asthma Registry (ISAR) was established in 2017 to advance the understanding of severe asthma and its management, thereby improving patient care worldwide. As the first global registry for adults with severe asthma, ISAR enabled individual registries to standardize and pool their data, creating a comprehensive, harmonized dataset with sufficient statistical power to address key research questions and knowledge gaps. Today, ISAR is the largest repository of real-world data on severe asthma, curating data on nearly 35,000 patients from 28 countries worldwide, and has become a leading contributor to severe asthma research. Research using ISAR data has provided valuable insights on the characteristics of severe asthma, its burdens and risk factors, real-world treatment effectiveness, and barriers to specialist care, which are collectively informing improved asthma management. Besides changing clinical thinking via research, ISAR aims to advance real-world practice through initiatives that improve registry data quality and severe asthma care. In 2024, ISAR refined essential research variables to enhance data quality and launched a web-based data acquisition and reporting system (QISAR), which integrates data collection with clinical consultations and enables longitudinal data tracking at patient, center, and population levels. Quality improvement priorities include collecting standardized data during consultations and tracking and optimizing patient journeys via QISAR and integrating primary/secondary care pathways to expedite specialist severe asthma management and facilitate clinical trial recruitment. ISAR envisions a future in which timely specialist referral and initiation of biologic therapy can obviate long-term systemic corticosteroid use and enable more patients to achieve remission.

Purpose: Early diagnosis of anastomotic leakage (AL) after colorectal surgery can reduce severe postoperative morbidity and ensure successful treatment. This study evaluated the feasibility of bedside endoscopic inspection of the anastomosis early postoperatively using a point-of-care digital rectoscope. Methods: This prospective study was conducted at 2 tertiary centers. Patients who underwent minimally invasive or open sphincter-preserving surgery with creation of a colorectal or coloanal anastomosis were included. Data were collected from December 2022 to October 2023. Bedside anastomotic inspections were performed postoperative day (POD) 3 to 5 using a point-of-care digital rectoscope. The primary outcome was feasibility, defined as adequate clinical assessment of the anastomosis during bedside inspection. Secondary outcomes included patient tolerability, efficacy compared to other diagnostic methods, and clinical outcomes during 90 days of follow-up. Results: In total, 35 patients were included. All bedside anastomotic inspections were carried out successfully. The examination showed complete visibility of the entire anastomosis in 30 patients (85.7%), with minimal discomfort reported by 3 (8.6%). No adverse events were recorded. AL occurred in 6 patients (17.1%), with 3 cases detected during bedside inspections between POD 3 and 5. Two leaks were detected without clinical or biochemical suspicion. Three patients with negative rectoscopy between POD 3 and 5 were later diagnosed with AL: 2 by a computed tomography scan and 1 by a bedside rectoscopy. Conclusion Bedside inspection of rectal anastomoses early postoperatively is feasible and tolerable for patients. Routine anastomotic inspections can detect early AL even without clear clinical or biochemical signs.

Purpose: Early diagnosis of anastomotic leakage (AL) after colorectal surgery can reduce severe postoperative morbidity and ensure successful treatment. This study evaluated the feasibility of bedside endoscopic inspection of the anastomosis early postoperatively using a point-of-care digital rectoscope. Methods: This prospective study was conducted at 2 tertiary centers. Patients who underwent minimally invasive or open sphincter-preserving surgery with creation of a colorectal or coloanal anastomosis were included. Data were collected from December 2022 to October 2023. Bedside anastomotic inspections were performed postoperative day (POD) 3 to 5 using a point-of-care digital rectoscope. The primary outcome was feasibility, defined as adequate clinical assessment of the anastomosis during bedside inspection. Secondary outcomes included patient tolerability, efficacy compared to other diagnostic methods, and clinical outcomes during 90 days of follow-up. Results: In total, 35 patients were included. All bedside anastomotic inspections were carried out successfully. The examination showed complete visibility of the entire anastomosis in 30 patients (85.7%), with minimal discomfort reported by 3 (8.6%). No adverse events were recorded. AL occurred in 6 patients (17.1%), with 3 cases detected during bedside inspections between POD 3 and 5. Two leaks were detected without clinical or biochemical suspicion. Three patients with negative rectoscopy between POD 3 and 5 were later diagnosed with AL: 2 by a computed tomography scan and 1 by a bedside rectoscopy. Conclusion Bedside inspection of rectal anastomoses early postoperatively is feasible and tolerable for patients. Routine anastomotic inspections can detect early AL even without clear clinical or biochemical signs.

The International Severe Asthma Registry (ISAR) was established in 2017 to advance the understanding of severe asthma and its management, thereby improving patient care worldwide. As the first global registry for adults with severe asthma, ISAR enabled individual registries to standardize and pool their data, creating a comprehensive, harmonized dataset with sufficient statistical power to address key research questions and knowledge gaps. Today, ISAR is the largest repository of real-world data on severe asthma, curating data on nearly 35,000 patients from 28 countries worldwide, and has become a leading contributor to severe asthma research. Research using ISAR data has provided valuable insights on the characteristics of severe asthma, its burdens and risk factors, real-world treatment effectiveness, and barriers to specialist care, which are collectively informing improved asthma management. Besides changing clinical thinking via research, ISAR aims to advance real-world practice through initiatives that improve registry data quality and severe asthma care. In 2024, ISAR refined essential research variables to enhance data quality and launched a web-based data acquisition and reporting system (QISAR), which integrates data collection with clinical consultations and enables longitudinal data tracking at patient, center, and population levels. Quality improvement priorities include collecting standardized data during consultations and tracking and optimizing patient journeys via QISAR and integrating primary/secondary care pathways to expedite specialist severe asthma management and facilitate clinical trial recruitment. ISAR envisions a future in which timely specialist referral and initiation of biologic therapy can obviate long-term systemic corticosteroid use and enable more patients to achieve remission.

INTRODUCTION: Outcomes after SARS-CoV-2 Omicron infection in patients with heart failure (HF) and ischaemic heart disease (IHD) remain poorly defined. METHOD: In a highly vaccinated cohort of adult Singapore citizens and permanent residents, we used Cox proportional hazards models (adjusted for sociodemographic variables and comorbidities) to compare the risks of Omicron infection, COVID-19- related hospitalisation, and severe COVID-19 between indivi-duals with HF or IHD and matched controls without these conditions. RESULTS: From national databases, we identified 15,426 HF patients matched 1:∼3 to 41,221 controls, and 110,442 IHD patients matched 1:∼2 to 223,843 controls. Over 80% of HF and IHD patients had received at least 3 vaccine doses. During the Omicron-predominant period, both HF and IHD cohorts demonstrated higher adjusted risks of COVID-19 hospitalisation compared with matched controls (HF: adjusted hazard ratio [aHR] 1.77, 95% confidence interval [CI] 1.65-1.90; IHD: aHR 1.21, 95% CI 1.17-1.26). Among those with at least 1 HF-or IHD-related admission in the prior year, hospitalisation risk was further elevated (HF: aHR 1.27, 95% CI 1.13-1.42; IHD: aHR 1.11, 95% CI 1.01-1.23). Receipt of ≥3 vaccine doses was associated with substantially lower risk of severe COVID-19 versus only 2 doses (HF: aHR 0.35, 95% CI 0.28-0.43; IHD: aHR 0.27, 95% CI 0.23-0.32). A fourth dose conferred additional reductions in infection and adverse outcomes, though CIs for infection overlapped with those for 3 doses. CONCLUSION During Omicron predominance, HF and IHD patients experienced greater risk of COVID-19 hospitalisation and severe COVID-19 versus matched controls. Booster vaccinations attenuated these risks. Individuals with recent HF/IHD admissions should be prioritised for receipt of booster vaccine doses.
Humans ; COVID-19/complications* ; Male ; Heart Failure/complications* ; Myocardial Ischemia/complications* ; Female ; Middle Aged ; Hospitalization/statistics & numerical data* ; Aged ; COVID-19 Vaccines/administration & dosage* ; Singapore/epidemiology* ; SARS-CoV-2 ; Proportional Hazards Models ; Adult ; Case-Control Studies ; Vaccination/statistics & numerical data*

BACKGROUND: The FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial demonstrated that percutaneous coronary intervention (PCI) lesion selection using quantitative flow ratio (QFR) measurement, a novel angiography-based approach for estimating fractional flow reserve, improved two-year clinical outcomes compared with standard angiography guidance. This study aimed to assess the cost-effectiveness of QFR-guided PCI from the perspective of the current Chinese healthcare system. METHODS: This study is a pre-specified analysis of the FAVOR III China trial, which included 3825 patients randomized between December 25, 2018, and January 19, 2020, from 26 centers in China. Patients with stable or unstable angina pectoris or those ≥72 hours post-myocardial infarction who had at least one lesion with a diameter stenosis between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment were randomized to a QFR-guided strategy or an angiography-guided strategy with 1:1 ratio. During the two-year follow-up, data were collected on clinical outcomes, quality-adjusted life-years (QALYs), estimated costs of index procedure hospitalization, outpatient cardiovascular medication use, and rehospitalization due to major adverse cardiac and cerebrovascular events (MACCE). The primary analysis calculated the incremental cost-effectiveness ratio (ICER) as the cost per MACCE avoided. An ICER of ¥10,000/MACCE event avoided was considered economically attractive in China. RESULTS: At two years, the QFR-guided group demonstrated a reduced rate of MACCE compared to the angiography-guided group (10.8% vs . 14.7%, P <0.01). Total two-year costs were similar between the groups (¥50,803 ± 21,121 vs . ¥50,685 ± 23,495, P = 0.87). The ICER for the QFR-guided strategy was ¥3055 per MACCE avoided, and the probability of QFR being economically attractive was 64% at a willingness-to-pay threshold of ¥10,000/MACCE avoided. Sensitivity analysis showed that QFR-guided PCI would become cost-saving if the cost of QFR were below ¥3682 (current cost: ¥3800). Cost-utility analysis yielded an ICER of ¥56,163 per QALY gained, with a 53% probability of being cost-effective at a willingness-to-pay threshold of ¥85,000 per QALY gained. CONCLUSION: In patients undergoing PCI, a QFR-guided strategy appears economically attractive compared to angiographic guidance from the perspective of the Chinese healthcare system. TRIAL REGISTRATION ClinicalTrials.gov , NCT03656848.
Humans ; Cost-Benefit Analysis ; Percutaneous Coronary Intervention/methods* ; Male ; Female ; Coronary Angiography/methods* ; Middle Aged ; Aged ; Coronary Artery Disease/surgery* ; Quality-Adjusted Life Years ; Fractional Flow Reserve, Myocardial/physiology*

Objective: Mortality surveillance was established in the state of Victoria just before the COVID-19 pandemic. Here, we describe the establishment of this surveillance system, justify the modelling approach selected, and provide examples of how the interpretation of changes in mortality rates during the pandemic was influenced by the model chosen. Methods: Registered deaths occurring in Victoria from 1 January 2015 to 31 December 2020 were sourced from the Victoria Death Index. Observed mortality rates were compared to a raw historical 5-year mean and to predicted means estimated from a seasonal robust regression. Differences between the observed mortality rate and the historical mean (delta-MR) and excess mortality rate from the observed and predicted rates were assessed. Results: There were 20 375 COVID-19 cases notified in Victoria as of 31 December 2020, of whom 748 (3.7%) died. Victorians aged >=85 years experienced the highest case fatality ratio (34%). Mean observed mortality rates in 2020 (MR: 11.6; 95% confidence interval [CI]: 11.4, 11.9) were slightly reduced when compared with the annual rate expected using the historical mean method (mean MR: 12.2; 95% CI: 12.1, 12.3; delta-MR: -0.57; 95% CI: -0.77, -0.38), but not from the rate expected using the robust regression (estimated MR: 11.7; 95% prediction interval [PI]: 11.5, 11.9; EMR: -0.05; 95% CI: -0.26, 0.16). The two methods yielded opposing interpretations for some causes, including cardiovascular and cancer mortality. Discussion: Interpretation of how pandemic restrictions impacted mortality in Victoria in 2020 is influenced by the method of estimation. Time-series approaches are preferential because they account for population trends in mortality over time.

The International Severe Asthma Registry (ISAR) was established in 2017 to advance the understanding of severe asthma and its management, thereby improving patient care worldwide. As the first global registry for adults with severe asthma, ISAR enabled individual registries to standardize and pool their data, creating a comprehensive, harmonized dataset with sufficient statistical power to address key research questions and knowledge gaps. Today, ISAR is the largest repository of real-world data on severe asthma, curating data on nearly 35,000 patients from 28 countries worldwide, and has become a leading contributor to severe asthma research. Research using ISAR data has provided valuable insights on the characteristics of severe asthma, its burdens and risk factors, real-world treatment effectiveness, and barriers to specialist care, which are collectively informing improved asthma management. Besides changing clinical thinking via research, ISAR aims to advance real-world practice through initiatives that improve registry data quality and severe asthma care. In 2024, ISAR refined essential research variables to enhance data quality and launched a web-based data acquisition and reporting system (QISAR), which integrates data collection with clinical consultations and enables longitudinal data tracking at patient, center, and population levels. Quality improvement priorities include collecting standardized data during consultations and tracking and optimizing patient journeys via QISAR and integrating primary/secondary care pathways to expedite specialist severe asthma management and facilitate clinical trial recruitment. ISAR envisions a future in which timely specialist referral and initiation of biologic therapy can obviate long-term systemic corticosteroid use and enable more patients to achieve remission.