RESUMEN
PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.
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Comprensión , Formularios de Consentimiento , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Investigación Biomédica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Educación del Paciente como Asunto , Encuestas y Cuestionarios , Tailandia , Adulto JovenRESUMEN
ABSTRACT: Neutrophil-to-lymphocyte ratio (NLR) was reported as an independent prognostic factor in many studies, but its cutoff point was not yet concluded. We set forth to prove and validate cutoff point of NLR as a poor prognostic factor for overall survival (OS) in nonmetastatic nasopharyngeal carcinoma (NPC) patients.Retrospective cohort of nonmetastatic NPC adult patients treated with intensity-modulated radiotherapy with curative aim at Siriraj hospital during 2007 to 2014 was enrolled. NLR was defined as absolute neutrophil count divided by absolute lymphocyte count. OS was the primary outcome. We explored our cutoff value by maximum concordance index (C-index) method, and we validated our cutoff and previously reported cutoff values by categorizing patients as NLRâ≤â3 or >3. Internal validation was done by bootstrapping method.Four hundred sixty-three patients were included. The median follow-up time was 70.8âmonths. By the end of June 2019, 211 patients had died. In univariable analysis of OS by Cox model, an NLR value of 3 showed the highest C-index (0.548) with an HR of 1.43 (95% CI: 1.08-1.89). After adjustment for body mass index, overall staging, age, gender, and histology in multivariable analysis, an NLR >3 was still an independent prognostic factor of poor OS (HRâ=â1.34, 95% CIâ=â1.01-1.79). After internal validation, the resampling method shows no overfitting condition and corrected C-index was 0.547 for univariable analysis.A cutoff point of NLR of 3 from routine blood test was found to be an independent poor prognostic factor among patients with nonmetastatic NPC. This prognostic factor could be included in clinical prediction model of NPC and this further prediction model would select high risk patients for intensive treatment.
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Recuento de Linfocitos/estadística & datos numéricos , Carcinoma Nasofaríngeo/sangre , Neoplasias Nasofaríngeas/sangre , Neutrófilos/metabolismo , Adulto , Anciano , Biomarcadores de Tumor , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos Estadísticos , Carcinoma Nasofaríngeo/mortalidad , Carcinoma Nasofaríngeo/radioterapia , Neoplasias Nasofaríngeas/mortalidad , Neoplasias Nasofaríngeas/radioterapia , Pronóstico , Modelos de Riesgos Proporcionales , Radioterapia de Intensidad Modulada , Valores de Referencia , Estudios RetrospectivosRESUMEN
BACKGROUND: Allergic rhinitis (AR) is a non-infectious immune disease and incidents of the disease has continuously increased in Thailand. Ginger, a Thai herb, is used in food and Thai traditional medicine. This study was designed to assess efficacy and safety of ginger extract in comparison with loratadine for AR treatment. METHODS: AR patients were treated with ginger extract 500 mg (n = 40) against those treated with loratadine 10 mg (n = 40) in a randomized, double-blind, controlled trial for 3 and 6 weeks. The efficacy was evaluated from clinical examinations i.e. total nasal symptom scores (TNSS), cross-sectional area of the nasal cavity with acoustic rhinometry (ARM) and rhinoconjunctivitis quality of life questionnaire (RQLQ). The safety of treatment was measured by blood pressure, blood analysis and history-taking for side effects. RESULTS: The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups. In acoustic rhinometry measurement, the ginger treated group significantly gradually increased the estimated volume of the nasal cavity and decreased distances from the nostril, but the loratadine treated group did not cause a change. Both groups gave significantly improvement in every aspect of the RQLQ at third weeks. The treatment with ginger extract was as safe as loratadine as shown by renal and liver function results obtained from blood analysis. Both treatments had no effect on blood pressure of the patients. CONCLUSIONS: The ginger extract is as good as loratadine in improving nasal symptoms and quality of life in AR patients. However, ginger extract caused less side effects especially, drowsiness, fatigue, dizziness and constipation. Therefore, the ginger extract could be used as alternative treatment for patients with AR. TRIAL REGISTRATION: Registered with ClinicalTrials.gov (Registration number: NCT02576808) on 15 October 2015.
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Loratadina/uso terapéutico , Extractos Vegetales/uso terapéutico , Rinitis Alérgica/tratamiento farmacológico , Zingiber officinale , Adulto , Método Doble Ciego , Femenino , Antagonistas de los Receptores Histamínicos H1 no Sedantes/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Encuestas y Cuestionarios , Tailandia , Adulto JovenRESUMEN
BACKGROUND/OBJECTIVE: We compared the surgery data of the department of otorhinolaryngology of the university hospitals in Japan and Thailand to make each feature and the differences of both otorhinolaryngology surgeries clear. There are some medical meetings and congresses between Japan and Thailand, but so far it has not reported about the comparison of surgery data. METHODS: Retrospectively, we analyzed the surgical statistics of department of otorhinolaryngology of Nihon University Itabashi Hospital (Japan) and Thammasat University Hospital (Thailand) between 2013 and 2014. RESULTS: In Japan, there were many surgeries involving the middle ear and paranasal sinuses whereas in Thailand, tracheotomy and tonsillectomy were more frequently performed. Statistical analysis of the surgical data revealed specific tendencies in the nature of the operations performed at each university. CONCLUSION: This study revealed that there are rather differences between two hospitals' surgeries features. It was thought that it would be beneficial to both institutions to gain a deeper understanding of the areas of expertise of each university in order to foster an environment conducive to increasing future international collaborations.