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PURPOSE: Both metabolic syndrome (MetS) and cognitive dysfunction impair health-related quality of life (HRQOL). This study aims to determine whether individuals experiencing both MetS and cognitive dysfunction have lower HRQOL. METHODS: This cross-sectional study enrolled 567 participants who attended outpatient clinics at a medical center in northern Taiwan. MetS was diagnosed according to the modified criteria for the Asian population. Cognitive function was categorized as normal, mild cognitive dysfunction, and advanced cognitive dysfunction according to the score of the Montreal Cognitive Assessment, Taiwanese version. HRQOL was assessed using the SF-36v2® Health Survey (SF-36v2). The associations of the comorbidity status of MetS and cognitive dysfunction with HRQOL were analyzed using linear regression models, adjusting for age, sex, marital status, education level, income groups, and activities of daily living. RESULTS: Out of 567 participants, 33 (5.8%) had MetS with mild cognitive dysfunction, and 34 (6.0%) had MetS with advanced cognitive dysfunction. Participants with both MetS and advanced cognitive dysfunction exhibited the lowest scores in the physical component summary and almost all scales of HRQOL. MetS exacerbated the inverse association between mild cognitive dysfunction and the mental component summary. For those with MetS, the scores on scales of role physical, bodily pain, vitality, and social functioning worsened as cognitive function deteriorated (all Ptrend<0.05). CONCLUSION: As the severity of comorbidity between MetS and cognitive dysfunction varies, patients exhibited poorer performance in different aspects of HRQOL. Future research is needed to find solutions to improve HRQOL for patients with both MetS and cognitive dysfunction.
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BACKGROUND: Mental diseases continue to rank among the top 10 leading causes of global burden. Psychiatric research is a crucial avenue through which mental healthcare can be enhanced. Taiwanese academics have constantly concentrated their efforts on psychiatric research and published their findings. A systematic examination of these papers will provide an assessment of the present state and contribute to the formulation of future policies for psychiatric research in Taiwan. We assessed psychiatric papers from Taiwan using the Web of Science (WoS) database. METHODS: Academic papers in the Psychiatry category of the WoS database from Taiwan were retrieved and evaluated. The analysis included papers published in Science Citation Index-Expanded and Social Science Citation Indexed journals between 1970 and 2023, excluding meeting abstracts and corrections. RESULTS: Of the 1 049 281 papers published globally in the Psychiatry category of the WoS system between 1970 and 2023, 6117 (0.58%) were published in Taiwan. Taiwan ranked 26th globally in terms of number of papers published. These publications have received 150 519 citations. Over the past 53 years, both the annual number of psychiatric papers from Taiwan and their citations received have significantly and rapidly increased. However, the average impact factor of publications remained constant over time. CONCLUSION: Over the last five decades, the number of psychiatric publications from Taiwan has increased. However, the average impact factor of these published papers did not increase over time. Investing in advanced research infrastructure and interdisciplinary projects may improve the quality and relevance of Taiwanese psychiatric research publications, potentially increasing their global citations and impact.
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Psiquiatría , Taiwán , Humanos , Bibliometría , Factor de Impacto de la Revista , Bases de Datos BibliográficasRESUMEN
BACKGROUND: The recently approved AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) demonstrated high efficacy against RSV-related disease in ≥60-year-olds. METHODS: This ongoing phase 3 study in ≥60-year-olds evaluates immune persistence until 3 years after RSVPreF3 OA vaccination. Here, we describe interim results on humoral and cell-mediated immunogenicity, reactogenicity, and safety until 1 year post-dose 1. RESULTS: In total, 1653 participants were vaccinated. One month post-dose 1, neutralization titers increased 10.5-fold (RSV-A) and 7.8-fold (RSV-B) vs pre-dose 1. Titers then declined to levels 4.4-fold (RSV-A) and 3.5-fold (RSV-B) above pre-dose 1 at month 6 and remained 3.1-fold (RSV-A) and 2.3-fold (RSV-B) above pre-dose 1 levels after 1 year. RSVPreF3-binding immunoglobulin G levels and CD4+ T-cell frequencies showed similar kinetics. Solicited administration-site and systemic adverse events (mostly mild to moderate and transient) were reported by 62.2% and 49.5% of participants. Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related. CONCLUSIONS: One RSVPreF3 OA dose elicited cell-mediated and RSV-A- and RSV-B-specific humoral immune responses that declined over time but remained above pre-dose 1 levels for at least 1 year. The vaccine was well tolerated with an acceptable safety profile. Clinical Trials Registration. NCT04732871 (ClinicalTrials.gov).
Respiratory syncytial virus (RSV) is a major cause of illness and hospitalization in older adults. An RSV vaccine for older adults developed by GSK was recently approved. The vaccine was well tolerated and provided protection against RSV disease in adults aged ≥60 years during at least 1 RSV season. In this ongoing study, we are evaluating the magnitude and durability of the immune response, as well as vaccine safety, until 3 years after vaccination of adults aged ≥60 years from 5 countries. Here, we report the results of an interim analysis until 1 year after vaccination with 1 dose. In total, 1653 participants were vaccinated. We found that the vaccine induced a strong immune response that was evident 1 month after vaccination, after which it declined but persisted for at least 1 year. Study participants most often reported pain at the injection site, muscle pain, tiredness, and headache as adverse reactions, which were mostly mild to moderate and of short duration. One serious adverse reaction was considered related to the vaccine. The long-term immune response that was observed in this study is consistent with the vaccine providing protection during at least 1 RSV season.
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Anticuerpos Antivirales , Infecciones por Virus Sincitial Respiratorio , Vacunas contra Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Humanos , Vacunas contra Virus Sincitial Respiratorio/inmunología , Vacunas contra Virus Sincitial Respiratorio/administración & dosificación , Vacunas contra Virus Sincitial Respiratorio/efectos adversos , Masculino , Femenino , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/inmunología , Anticuerpos Antivirales/sangre , Anciano , Persona de Mediana Edad , Virus Sincitial Respiratorio Humano/inmunología , Proteínas Virales de Fusión/inmunología , Proteínas Virales de Fusión/administración & dosificación , Anticuerpos Neutralizantes/sangre , Inmunogenicidad Vacunal , Anciano de 80 o más Años , Adyuvantes de Vacunas/administración & dosificaciónRESUMEN
BACKGROUND: Traditional Chinese medicine (TCM) is widely used by ethnic Chinese communities. TCM is covered by Taiwan's National Health Insurance (NHI) program. We evaluated the efficacy and outcomes of complementary Chinese herbal medicine (CHM) therapy in patients with cancer. METHODS: This population-based cohort study was conducted using the data of patients who received a cancer diagnosis between 2005 and 2015 in Taiwan. Eligible patients were divided into standard and complementary CHM therapy groups. The complementary CHM therapy group was further divided into low cumulative dosage (LCD), medium cumulative dosage (MCD), and high cumulative dosage (HCD) subgroups. Overall survival (OS), mortality risk, cancer recurrence, and metastasis were analyzed for all cancers and five major cancers (lung, liver, breast, colorectal, and oral cancers). RESULTS: We included 5707 patients with cancer (standard therapy, 4797 [84.1%]; complementary CHM therapy, 910 [15.9%]; LCD, 449 [7.9%]; MCD, 374 [6.6%], and HCD, 87 [1.5%]). For the LCD, MCD, and HCD subgroups, the mortality risk was 0.83, 0.64, and 0.45, and the 11-year OS, 5-year cumulative cancer recurrence, and 5-year cumulative cancer metastasis rates were 6.1 ± 0.2, 6.9 ± 0.2, and 8.2 ± 0.4 years; 39.2%, 31.5%, and 18.8%; and 39.5%, 32.8%, and 16.6%, respectively. The cumulative cancer recurrence and metastasis rates of the standard therapy group were 40.9% and 32.8%, respectively. The cumulative recurrence and metastasis rates of all cancers, lung cancer, and liver cancer and all cancers, colorectal cancer, and breast cancer, respectively, were significantly lower in the HCD subgroup than in the other subgroups and standard therapy group ( p < 0.05). CONCLUSION: Patients receiving complementary CHM therapy may have prolonged OS and reduced risks of mortality, recurrence, and metastasis. A dose-response relationship was noted between CHM therapy and mortality risk: increased dosage was associated with improved OS and reduced mortality risk.
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Medicamentos Herbarios Chinos , Humanos , Estudios de Cohortes , Medicamentos Herbarios Chinos/uso terapéutico , Taiwán , Recurrencia Local de Neoplasia , Medicina Tradicional ChinaRESUMEN
BACKGROUND: Chat Generative Pre-trained Transformer (ChatGPT), OpenAI Limited Partnership, San Francisco, CA, USA is an artificial intelligence language model gaining popularity because of its large database and ability to interpret and respond to various queries. Although it has been tested by researchers in different fields, its performance varies depending on the domain. We aimed to further test its ability in the medical field. METHODS: We used questions from Taiwan's 2022 Family Medicine Board Exam, which combined both Chinese and English and covered various question types, including reverse questions and multiple-choice questions, and mainly focused on general medical knowledge. We pasted each question into ChatGPT and recorded its response, comparing it to the correct answer provided by the exam board. We used SAS 9.4 (Cary, North Carolina, USA) and Excel to calculate the accuracy rates for each question type. RESULTS: ChatGPT answered 52 questions out of 125 correctly, with an accuracy rate of 41.6%. The questions' length did not affect the accuracy rates. These were 45.5%, 33.3%, 58.3%, 50.0%, and 43.5% for negative-phrase questions, multiple-choice questions, mutually exclusive options, case scenario questions, and Taiwan's local policy-related questions, with no statistical difference observed. CONCLUSION: ChatGPT's accuracy rate was not good enough for Taiwan's Family Medicine Board Exam. Possible reasons include the difficulty level of the specialist exam and the relatively weak database of traditional Chinese language resources. However, ChatGPT performed acceptably in negative-phrase questions, mutually exclusive questions, and case scenario questions, and it can be a helpful tool for learning and exam preparation. Future research can explore ways to improve ChatGPT's accuracy rate for specialized exams and other domains.
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Rendimiento Académico , Inteligencia Artificial , Medicina Familiar y Comunitaria , Bases de Datos Factuales , TaiwánRESUMEN
BACKGROUND: Terminally ill patients often experience exacerbations of diseases that render mainstream medicine ineffective in relieving symptoms, prompting attempts at complementary and alternative medicine (CAM). This study collected data from terminally ill patients and their relatives to determine differences between CAM use, behavioral patterns, and perceptions of health information about CAM. METHODS: A cross-sectional design using a self-administered questionnaire was adopted. Eight medical institutions in Taiwan with inpatient hospice palliative care units were chosen. Ninety-two terminally ill patients and 267 relatives met the inclusion criteria. The questions concerned the experience of CAM use, the kinds of products/services CAM provided, the purpose of CAM use, the source of CAM information, and the perceptions and attitudes toward CAM. RESULTS: Both terminally ill patients and their relatives have a high proportion of lifetime and one-year prevalence of CAM use (88.0% vs. 88.4%; p = 0.929). CAM use for musculoskeletal and neurological discomfort is higher among terminally ill patients than among their relatives. Relatives/friends are the most frequent sources of information on CAM (53.3% vs. 62.2%; p = 0.133). The percentage of terminally ill patients who discontinued mainstream medical treatment because of CAM use was higher than that of their relatives (18.5% vs. 9.3%; p = 0.026). More than half the terminally ill patients and their relatives had never been asked about CAM by medical staff (64.1% vs. 66.7%), nor had they informed medical professionals about the use of CAM products and services (63% vs. 66.9%). Random inquiries by medical professionals may be associated with increased disclosure of CAM use (terminally ill patients: odds ratio, 9.75; 95% confidence interval, 1.97-48.35 vs. relatives: odds ratio, 5.61; 95% confidence interval, 2.66-11.83). CONCLUSIONS: The high prevalence and concealment of CAM use in terminally ill patients should be considered. Medical professionals should establish a friendly and barrier-free communication model, encourage patients to share CAM experiences, and provide evidence-based information on the use of CAM products and services, to reduce the potential damage caused by harmful use.
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Terapias Complementarias , Hospitales para Enfermos Terminales , Humanos , Pacientes Internos , Enfermo Terminal , Estudios TransversalesRESUMEN
Purpose: Diabetes increases the risk of fragility fractures. As a result, when choosing a diabetes treatment, whether the drug affects bone density should be taken into account. The goal of this study was to determine how switching from dipeptidyl peptidase-4 inhibitors (DPP-4i) to glucagon-like peptide-1 receptor agonists (GLP-1RA) influenced bone mineral density (BMD) in diabetic patients. Patients and Methods: In this retrospective cohort study, diabetic patients with osteoporosis or osteopenia who used DPP-4i but not anti-osteoporosis medications were divided into two groups: those who switched to GLP-1RA (n = 132) and those who did not (control group, n = 133). We compared changes in glycemic control and BMD with and without conversion from DPP-4i to GLP-1RA. Results: Prior to switching, there was no difference between the groups in terms of age, gender, glycosylated hemoglobin (HbA1c), or BMD. HbA1c was 8.7% in the participants (mean age 62.7 years, 17.4% female). Despite the fact that there was no difference in femoral neck BMD, the GLP-1RA group had a greater decrease in lumbar spine BMD (-0.028 g/cm2 versus -0.019 g/cm2, p = 0.041) than the control group. Furthermore, HbA1c levels in the GLP-1RA-treated group were considerably lower than in the control group (7.5% versus 8.0%, p = 0.027). Conclusion: While switching to GLP-1RA improves glycemic control, it appears to have a less favorable effect on bone density than continuing DPP-4i. More research is needed, however, to determine whether diabetic patients with low bone density should be switched from DPP-4i to GLP-1RA.
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BACKGROUND: High-dose influenza vaccine offers better protection against influenza/associated complications compared with standard-dose formulation. We evaluated immunogenicity and safety of high-dose influenza vaccine (QIV-HD) and standard-dose (QIV-SD) in older adults (≥ 65 years) in Taiwan. METHODS: This was a phase III, randomized, modified double-blind, active-controlled, multi-center, descriptive study in older adults. Participants (N = 165) were randomized 1:1 to receive QIV-HD or QIV-SD vaccine (clinicaltrials.gov#NCT04537234). RESULTS: For all four influenza strains, geometric means titers (GMTs) of hemagglutination inhibition were higher for the QIV-HD than QIV-SD with adjusted GMT ratios (95 % CI) of 2.65 (1.87-3.75) for A/H1N1; 1.76 (1.31-2.38) for A/H3N2; 2.60 (1.90-3.56) for B/Victoria; and 2.01 (1.57-2.56) for B/Yamagata. The seroconversion was higher for QIV-HD than QIV-SD with similar safety profiles across both groups. CONCLUSION: QIV-HD was highly immunogenic for four influenza strains and have acceptable safety profile in older adults aged ≥ 65 years in Taiwan.
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Subtipo H1N1 del Virus de la Influenza A , Vacunas contra la Influenza , Gripe Humana , Humanos , Anciano , Gripe Humana/prevención & control , Virus de la Influenza B , Subtipo H3N2 del Virus de la Influenza A , Vacunas de Productos Inactivados , Taiwán , Anticuerpos Antivirales , Pruebas de Inhibición de Hemaglutinación , Método Doble Ciego , Vacunas Combinadas , Inmunogenicidad VacunalRESUMEN
Background: For people who are overweight or obese, maintaining a metabolically healthy status can decrease the risks of developing cardiovascular diseases and Type 2 diabetes. Despite this, only a limited amount of research has discussed the metabolically healthy overweight and obesity (MHOO) population in Asia and the factors associated with them maintaining their metabolic health. Methods: This study enrolled 195 MHOO participants from communities in northern Taiwan during 2009-2010 (baseline). Of the 195 participants, 89 completed the follow-up assessment after a median follow-up time of nine years. Body type was determined by body mass index (BMI, kg/m2). We defined overweight as a BMI ≥ 24 kg/m2 and <27 kg/m2 and defined obese as a BMI ≥ 27 kg/m2. Metabolic health was defined as the absence of cardiometabolic diseases and the presence of ≤1 of the cardiometabolic risk factors, namely hypertension, hyperglycemia, hypertriglyceridemia, and low serum high-density lipoprotein cholesterol. Metabolic health, BMI, and other covariates were evaluated at both baseline and follow-up. Generalized estimating equations (GEE) models were used to analyze the factors associated with maintenance of metabolic health during the follow-up period. Results: At baseline, the mean age of the study participants was 47.4 (SD 5.3) years and 46 (51.7%) of the participants were women. There were 51 (57.3%) individuals who maintained their metabolic health status at the time of the nine-year follow-up. The detrimental factors pertaining to metabolic health included older age, longer duration until follow-up, BMI ≥ 27 kg/m2, and increase in waist circumference. No significant relationships were observed between sociodemographic factors and lifestyle factors, such as sex, level of education, cigarette smoking, alcohol consumption, and physical activity, and sustained metabolic health among MHOO individuals. Conclusions: To maintain metabolic health and prevent negative changes in health status, control of bodyweight and waist circumference should remain a priority for MHOO individuals even when there are no metabolic disorders present.
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Obesidad Metabólica Benigna , Humanos , Femenino , Persona de Mediana Edad , Masculino , Sobrepeso/epidemiología , Diabetes Mellitus Tipo 2/complicaciones , Factores de Riesgo , Obesidad/epidemiología , Enfermedades Cardiovasculares/complicaciones , Obesidad Metabólica Benigna/epidemiologíaRESUMEN
BACKGROUND: Benign prostatic hyperplasia (BPH) can affect quality of life and cause various complications. Previous studies have suggested that Chinese herbal medicine can alleviate symptoms in patients with BPH. This study aimed to investigate whether the Chinese herbal medicine prescription VGH-BPH1 can alleviate BPH symptoms when used as an add-on treatment. METHODS: In this crossover, randomized, double-blind, placebo-controlled trial, patients with BPH were randomly segregated into two groups: group A received VGH-BPH1, and group B received a placebo for 8 weeks. Subsequently, after a 2-week wash-out period, the two groups were switched to the opposite treatment for another 8 weeks. The International Prostate Symptoms Score and Aging Male Symptoms Score were adopted as the primary outcomes to assess improvement in BPH and patient quality of life. The secondary outcomes were the International Index of Erectile Function, Constitution Chinese Medicine Questionnaire, uroflowmetry results, and postvoid residual urine volume. RESULTS: VGH-BPH1 treatment significantly decreased the International Prostate Symptoms Score total score (p = 0.027); however, no significant difference was observed between the treatment and placebo groups. The Aging Male Symptoms Score "joint pain and muscular ache" score in the VGH-BPH1 group was significantly lower than that of the placebo group (p = 0.022). The "physical exhaustion" score also exhibited a decreasing trend when both groups were compared (p = 0.057). CONCLUSION: Although VGH-BPH1 treatment did not outperform the placebo in terms of improving BPH symptoms, it resulted in improvement in several quality of life indicators when relative to the placebo. Future research using a larger sample size with appropriate amendments to the protocol should be conducted to further investigate the effects of VGH-BPH1.
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Medicamentos Herbarios Chinos , Hiperplasia Prostática , Estudios Cruzados , Método Doble Ciego , Medicamentos Herbarios Chinos/uso terapéutico , Humanos , Masculino , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/tratamiento farmacológico , Calidad de Vida , Resultado del TratamientoRESUMEN
BACKGROUND: There is limited information regarding the effectiveness of influenza vaccines for older adults. Particularly, controlling for healthy senior bias is challenging in observational studies. We aimed to assess the efficacy of influenza vaccination in the elderly while addressing potential healthy senior bias and whether it was related to virus-vaccine strains matching. METHOD: To control between-individual confounder, we used a case-crossover study design using Taiwan's National Health Insurance Research Dataset to analyse the association between influenza vaccination in older adults and the risk of hospitalisation for community-acquired pneumonia (CAP). Individuals were a 'case' in vaccinated years and a 'control' in unvaccinated years. The study periods were 2006/2007 and 2007/2008 seasons because virus-vaccine strains were matching in 2006/2007 season and unmatching in 2007/2008 season. Older adults were categorised into two groups: admitted for CAP during the pre-vaccination period (Admitted, n=311) and not hospital admitted for CAP (Non-admitted, n=572 432). The outcome was hospitalisation for CAP during the influenza period. Conditional logistic regression assessed influenza vaccine efficacy in reducing CAP. RESULTS: Influenza vaccination had no protective effects in Admitted group. However, because of the tiny numbers in Admitted group, we could draw very limited conclusions. Receiving an influenza vaccine significantly prevented CAP in Non-admitted group only during the vaccine-circulating strain-matched year (OR, 0.72; 95% CI, 0.64 to 0.83). In addition, there was no protective effect against CAP hospitalisation among individuals with a Charlson Comorbidity Index score over 2. CONCLUSION: Influenza vaccine efficacy was associated with vaccine-circulating strain-matched. When vaccine-circulating strains were all matching, receiving a shot reduced the probability of CAP hospitalisation by 28% in Non-admitted group. However, high comorbidity may reduce the vaccine efficacy. Therefore, it is necessary to educate older adults to receive annual influenza vaccination and in combination with non-pharmaceutical interventions to reduce the risk of CAP.
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Vacunas contra la Influenza , Gripe Humana , Anciano , Estudios Cruzados , Humanos , Gripe Humana/prevención & control , Estaciones del Año , VacunaciónRESUMEN
Based on the 1978 Alma-Ata Declaration, the key to achieving health for all is primary health care, and many countries have established various comprehensive health care systems. Because of the financial toll of a public health care system, government-sponsored public health insurance is not universally accepted. This study used Taiwan as the backdrop to understand why many health clinics have chosen not to accept the National Health Insurance (NHI), despite it covering 99.93% of the country's population. The clinics' operational details were garnered from the datasets of Taiwan's open government data platforms and checked against the list of contracting clinics within the NHI. Of 10,907 Western medicine primary care clinics in 2016, as many as 9846 (90.3%) clinics had signed contracts with the NHI. The remaining 1061 noncontracting clinics were distributed in urban (94.5%, n = 1003), suburban (4.9%, n = 52), and rural/remote areas (0.6%, n = 6). The NHI did not have contracts with 183 plastic surgery, 88 internal medicine, and 85 surgery clinics. In conclusion, nearly one-tenth of clinics practiced independently of the NHI in Taiwan. Their reasons for declining the contract and practices for delivering their services deserve further studies.
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Accesibilidad a los Servicios de Salud , Programas Nacionales de Salud , Instituciones de Atención Ambulatoria , Encuestas y Cuestionarios , Taiwán/epidemiologíaRESUMEN
Research plays a crucial role in the development of primary health care. Researchers in other specialities have studied the internationalisation of their journals, but no such study has been conducted for general practice. The aim of this study was to analyse the volume of publication and internationalisation of general practice journals indexed in the Science Citation Index (SCI) database in 2019. Of the total 1573 articles and reviews in 19 journals indexed under the subject category of 'primary health care' in the SCI database, 86.4% (n = 1359) were published in four English-speaking countries (32.8% in seven US journals, 34.8% in five UK journals, 12.5% in two Australian journals and 6.4% in one Canadian journal) and 40.6% (n = 639) were authored or coauthored by authors from a country other than that in which the journal was published. There was a significant (P < 0.05) relationship between the country of publication and the degree of internationalisation of the journal. The degree of internationalisation of general practice journals varied from 94.2% for family practice to 2.0% for primary care. There are wide disparities in internationalisation among different countries and general practice journals. There is much room for improvement in the internationalisation of general practice journals in the SCI database.
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Medicina Familiar y Comunitaria , Publicaciones Periódicas como Asunto , Australia , Bibliometría , Canadá , HumanosRESUMEN
BACKGROUND: This study aimed to assess the safety and immunogenicity of MVC-COV1901, a recombinant COVID-19 protein vaccine, containing S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide, for people living with HIV (PWH). METHODS: A total of 57 PWH of ≥20 years of age who are on stable antiretroviral therapy were compared with 882 HIV-negative participants. Participants received two doses of MVC-COV1901 28 days apart. RESULTS: No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in PWH and comparators, respectively, 28 days after the second dose. After adjusting for sex, age, BMI category, and comorbidity, the adjusted GMT ratio of comparator/PWH was 3.2 (95% CI 2.5-4). A higher CD4/CD8 ratio was associated with a higher GMT (R = 0.27, p = 0.039). MVC-COV1901 has shown robust safety but elicited weaker immune responses in PWH. CONCLUSIONS: Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).
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BACKGROUND: This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after ≥2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. METHODS: Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing ≥2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. RESULTS: Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. CONCLUSIONS: Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination. Clinical Trials Registration. NCT02723773.
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Vacuna contra el Herpes Zóster , Herpes Zóster , Adyuvantes Inmunológicos , Anciano , Estudios de Seguimiento , Herpes Zóster/prevención & control , Herpesvirus Humano 3 , Humanos , Persona de Mediana Edad , Vacunas SintéticasRESUMEN
The association between metabolically healthy obesity (MHO) and health-related quality of life (HRQOL) has not been thoroughly evaluated. This study enrolled 906 adult participants aged 35-55 years between 2009 and 2010 in Northern Taiwan; 427 participants were followed up after eight years. Normal weight, overweight, and obesity were evaluated via body mass index. Metabolic health was defined as the absence of cardiometabolic diseases and having ≤1 metabolic risk factor. HRQOL was evaluated using the 36-Item Short Form Health Survey (SF-36), Taiwan version. Generalized linear mixed-effects models were used to analyze the repeated, measured data with adjustment for important covariates. Compared with metabolically healthy normal weight individuals, participants with metabolically unhealthy normal weight and obesity had a significantly poorer physical component summary score (ß (95% CI) = -2.17 (-3.38--0.97) and -2.29 (-3.70--0.87), respectively). There were no significant differences in physical and mental component summary scores among participants with metabolically healthy normal weight, overweight, and obesity. This study showed that metabolically healthy individuals with obesity and normal weight had similar HRQOL in physical and mental component summary scores. Maintaining metabolic health is an ongoing goal for people with obesity.
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Metabolic syndrome (MetS) is associated with cardiovascular diseases, type 2 diabetes, chronic renal diseases, and all-cause mortality. Furthermore, MetS is associated with poor health-related quality of life (HRQOL). However, the impact of dynamic changes in MetS on changes in the HRQOL was not previously explored. This was an eight-year, prospective cohort study in which 906 middle-aged adults from Shipai, Taipei in northern Taiwan were enrolled during 2009-2010 (baseline). Of those sampled, 427 participants completed the follow-up investigation after 8 years. The HRQOL was measured using the Short Form Health Survey (SF-36). Other variables including age, sex, marital status, level of education, smoking, alcohol consumption, baseline body mass index, and changes in physical activity were adjusted. Compared with adults who never experienced MetS, adults with persistent MetS had a negative change in mental HRQOL (ß - 4.20, 95% CI - 7.54 to - 0.86, p = 0.01). The negative changes of persistent MetS on the HRQOL were in the domains of vitality and mental health (ß - 4.42, 95% CI - 8.10 to - 0.73 and ß - 3.47, 95% CI - 6.90 to - 0.04, respectively). Women and overweight adults were vulnerable to the detrimental effects of persistent MetS. For better HRQOL, more resources should be devoted to reversing MetS in public health.
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Vida Independiente/psicología , Síndrome Metabólico/psicología , Sobrepeso/epidemiología , Calidad de Vida/psicología , Adulto , Índice de Masa Corporal , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sobrepeso/complicaciones , Sobrepeso/psicología , Estudios Prospectivos , Factores de Riesgo , Caracteres Sexuales , Taiwán/epidemiologíaRESUMEN
BACKGROUND: MVC-COV1901, a recombinant protein vaccine containing pre-fusion-stabilised spike protein S-2P adjuvanted with CpG 1018 and aluminium hydroxide, has been shown to be well tolerated with a good safety profile in healthy adults aged 20-49 years in a phase 1 trial, and provided a good cellular and humoral immune responses. We present the interim safety, tolerability, and immunogenicity results of a phase 2 clinical trial of the MVC-COV1901 vaccine in Taiwan. METHODS: This is a large-scale, double-blind, randomised, placebo-controlled phase 2 trial done at ten medical centres and one regional hospital in Taiwan. Individuals aged 20 years or older who were generally healthy or had stable pre-existing medical conditions were eligible for enrolment. Exclusion criteria included (but were not limited to) travel overseas within 14 days of screening, intention to travel overseas within 6 months of the screening visit, and the absence of prespecified medical conditions, including immunosuppressive illness, a history of autoimmune disease, malignancy with risk to recur, a bleeding disorder, uncontrolled HIV infection, uncontrolled hepatitis B and C virus infections, SARS-CoV-1 or SARS-CoV-2 infections, an allergy to any vaccine, or a serious medical condition that could interfere with the study. Study participants were randomly assigned (6:1) to receive two doses of either MVC-COV1901 or placebo, administered via intramuscular injection on day 1 and day 29. MVC-COV1901 contained 15 µg of S-2P protein adjuvanted with 750 µg CpG 1018 and 375 µg aluminium hydroxide in a 0·5 mL aqueous solution, and the placebo contained the same volume of saline. Randomisation was done centrally by use of an interactive web response system, stratified by age (≥20 to <65 years and ≥65 years). Participants and investigators were masked to group assignment. The primary outcomes were to evaluate the safety, tolerability, and immunogenicity of MVC-COV1901 from day 1 (the day of the first dose) to day 57 (28 days after the second dose). Safety was assessed in all participants who received at least one dose. Immunogenicity was assessed by measuring geometric mean titres (GMTs) and seroconversion rates of neutralising antibody and antigen-specific IgG in the per-protocol population. This study is registered with ClinicalTrials.gov, NCT04695652. FINDINGS: Of 4173 individuals screened between Dec 30, 2020, and April 2, 2021, 3854 were enrolled and randomly assigned: 3304 to the MVC-COV1901 group and 550 to the placebo group. A total of 3844 participants (3295 in the MVC-COV1901 group and 549 in the placebo group) were included in the safety analysis set, and 1053 participants (903 and 150) had received both doses and were included in the per-protocol immunogenicity analysis set. From the start of this phase 2 trial to the time of interim analysis, no vaccine-related serious adverse events were recorded. The most common solicited adverse events in all study participants were pain at the injection site (2346 [71·2%] of 3295 in the MVC-COV1901 group and 128 [23·3%] of 549 in the placebo group), and malaise or fatigue (1186 [36·0%] and 163 [29·7%]). Fever was rarely reported (23 [0·7%] and two [0·4%]). At 28 days after the second dose of MVC-COV1901, the wild-type SARS-CoV-2 neutralising antibody GMT was 662·3 (95% CI 628·7-697·8; 408·5 IU/mL), the GMT ratio (geometric mean fold increase in titres at day 57 vs baseline) was 163·2 (155·0-171·9), and the seroconversion rate was 99·8% (95% CI 99·2-100·0). INTERPRETATION: MVC-COV1901 has a good safety profile and elicits promising immunogenicity responses. These data support MVC-COV1901 to enter phase 3 efficacy trials. FUNDING: Medigen Vaccine Biologics and Taiwan Centres for Disease Control, Ministry of Health and Welfare.
Asunto(s)
Adyuvantes Inmunológicos , Hidróxido de Aluminio , Vacunas contra la COVID-19/inmunología , COVID-19 , Infecciones por VIH , Oligodesoxirribonucleótidos , Adulto , Anciano , Anticuerpos Neutralizantes/sangre , Anticuerpos Antivirales/sangre , Método Doble Ciego , Humanos , Persona de Mediana Edad , SARS-CoV-2 , Taiwán , Adulto JovenRESUMEN
OBJECTIVES: Compassionate community models, successfully applied in several Western countries, have not been extensively promoted in Asian countries. This study explored primary care staff's willingness to participate and factors associated with their participations in compassionate community education and network, palliative care education, providing palliative care and the barriers they faced. METHODS: Adopting a mixed quantitative-qualitative design, primary care staffs in Beitou and Shilin districts in Taiwan, including physicians, nurses, pharmacists and administrative staff aged ≥20 years who had worked in a clinic for more than 2 months, were recruited. A questionnaire survey was conducted to explore their willingness to participate in compassionate community education and networks and palliative care education and care provision. Logistic regression was used to evaluate factors associated with their willingness, and qualitative perceptions were evaluated by open questions. RESULTS: About half of the respondents were willing to participate in compassionate community education and network and palliative care education, but only 19.5% were willing to provide palliative care. Compared with other staff, primary care nurses showed significantly more willingness to participate in compassionate community education and network and palliative care education and to provide palliative care. However, physicians were significantly not willing to participate in any of the three services apart from providing care. Capability, administrative and manpower concerns, time, age and motivation were the main barriers. CONCLUSIONS: To encourage primary care staff to participate more in compassionate community education and network and palliative care education and to provide palliative care, policymakers should pay more attention towards removing the barriers to their engagement.
Asunto(s)
Cuidados Paliativos , Médicos , Redes Comunitarias , Empatía , Humanos , Atención Primaria de SaludRESUMEN
Family physicians play an essential role as gatekeepers in primary health care. However, most studies in the past focused on the geographic maldistribution of family physicians, and few studies focused on the distribution of family physicians between private practices and hospitals. This study aims to analyze the trends in practice locations of family physicians in Taiwan between 1999 and 2018, using the databases of the Taiwan Association of Family Medicine and Taiwan Medical Association. Although the annual number of physicians registered as family physicians had steadily increased from 1876 in 1999 to 3655 in 2018, the ratio of family physicians practicing in hospitals to total family physicians remained stable around 40% in the study period. Even after eliminating the trainees who were entirely registered at hospitals, the proportion of hospital-based family physicians still accounted for about one-third of the total in each year. In conclusion, family physicians had been continuously demanded by hospitals in Taiwan. If the supply of primary care-oriented family physicians is insufficient outside hospitals, health manpower planning would require urgent adjustments.