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Article in English | WPRIM (Western Pacific) | ID: wprim-782097


OBJECTIVES: An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer.METHODS: Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m2, n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA/homologous recombination deficiency (HRD) genes, because BRCA/HRD mutations (BRCA/HRDm) are known to be associated with better prognosis.RESULTS: Enrollment was slow, accrual was closed when 7+ years had passed. With a median follow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19–0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA/HRDm was not significantly biased between the two arms. Wild-type BRCA/non-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11–1.18; p=0.091).CONCLUSIONS: Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer.

Arm , Asian Continental Ancestry Group , Bias , Carboplatin , Disease-Free Survival , Doxorubicin , Drug Therapy , Follow-Up Studies , Humans , Maintenance Chemotherapy , Ovarian Neoplasms , Prognosis , Quality of Life , Recombination, Genetic , Sample Size
Article in English | WPRIM (Western Pacific) | ID: wprim-786144


OBJECTIVE: To systematically investigate the relationship between circulating interleukin-17 (IL-17) levels and systemic lupus erythematosus (SLE) and associations between polymorphisms in IL17 genes and SLE susceptibility.METHODS: We performed a meta-analysis of serum/plasma IL-17 levels in patients with SLE and controls and evaluated the associations between the IL17A rs2275913, IL17F rs763780, and IL17F rs2397084 polymorphisms and IL17F copy number variations (CNVs) and risk of SLE.RESULTS: Thirteen studies focusing on 2,096 patients with SLE and 2,587 controls were included. Our meta-analysis revealed that IL-17 levels were significantly higher in the SLE group than the control group (standardized mean difference=1.045, 95% confidence interval [95% CI]=0.521~1.568, p < 0.001). Subgroup analysis using sample size showed increased IL-17 levels in samples from large (n>100) but not small (n < 90) SLE groups. We found no evidence of associations between SLE and the IL17A rs2275913, IL17F rs763780, and IL17F rs2397084 polymorphisms. However, a significant association was found between SLE and IL17F CNVs in a pooled cohort of affected individuals compared to that in pooled controls (odd ratio=3.663, 95% CI=2.466~5.221, p < 0.001).CONCLUSION: This meta-analysis revealed significantly higher circulating IL-17 levels in patients with SLE and showed evidence of associations between IL17F CNVs and SLE.

Cohort Studies , Disease Susceptibility , Humans , Interleukin-17 , Lupus Erythematosus, Systemic , Sample Size
Clin. biomed. res ; 40(1): 63-70, 2020.
Article in Portuguese | LILACS (Americas) | ID: biblio-1117821


Este artigo visa elucidar algumas dúvidas enfrentadas ou equívocos estatísticos cometidos por pesquisadores de diversas áreas. São explanados os temas: "tradução não é validação", "análise fatorial exploratória ou confirmatória", "nem todo estudo com dois grupos tem delineamento caso-controle", "teste ou ajuste de Bonferroni", "tamanho de amostra para teste de hipóteses e/ou para intervalo de confiança", e "testes ou dados paramétricos". A abordagem é realizada em uma linguagem acessível ao público leigo, utilizando exemplos e sugerindo referências para aprofundar o conhecimento.(AU)

This article aims to answer some questions and elucidate statistical misconceptions of researchers from different fields. The following topics are addressed: "translation is not validation", "exploratory or confirmatory factor analysis", "not every study with two groups is a case-control study", "Bonferroni test or adjustment", "sample size for testing hypotheses and/or for confidence intervals", and "parametric data or tests". The topics are explained in lay terms, using examples and suggesting references to advance knowledge.(AU)

Humans , Case-Control Studies , Factor Analysis, Statistical , Sample Size , Confidence Intervals , Data Interpretation, Statistical
Rev. gaúch. enferm ; 41(spe): e20190095, 2020. graf
Article in English | LILACS (Americas) | ID: biblio-1093864


ABSTRACT Aim: To analyze the behavior of B-type natriuretic peptide (BNP) in the presence of defining characteristics (DCs) of the nursing diagnosis Excess fluid volume (00026) in patients hospitalized for acute decompensated heart failure. Methods: Cohort study of patients admitted with acute decompensated heart failure (September 2015 to September 2016) defined by Boston Criteria. Patients hospitalized for up to 36 h with BNP values ≥ 100 pg/ml were included; BNP values at baseline-final assessment were compared by Wilcoxon test, the number of DCs at baseline-final assessment was compared by paired t-test. Results: Sixty-four patients were included; there was a significant positive correlation between delta of BNP and the number of DCs present at initial clinical assessment. Conclusions: The behavior of BNP was correlated to the DCs indicating congestion. With clinical compensation, DCs and BNP decreased. The use of this biomarker may provide additional precision to the nursing assessment.

RESUMEN Objetivo: Analizar el comportamiento del péptido natriurético tipo B (BNP) en presencia de características definitorias (CD) del diagnóstico de enfermería Exceso de volumen de líquidos (00026) en pacientes hospitalizados por insuficiencia cardíaca aguda descompensada (ICAD). Métodos: Estudio de cohorte de pacientes ingresados ​​con ICAD (septiembre/2015 a septiembre/2016).Se incluyeron pacientes hospitalizados hasta 36 h con valores de BNP ≥ 100 pg / ml; Los valores de BNP en la evaluación inicial basal se compararon mediante la prueba de Wilcoxon, el número de CD en la evaluación inicial basal se comparó mediante el Test-T apareado. Resultados: Se incluyeron 64 pacientes; hubo una correlación positiva significativa entre el delta del BNP y las CD presentes en la evaluación clínica inicial. Conclusiones: El comportamiento del BNP se correlacionó con las CD que indican congestión. Con compensación clínica, las CD y el BNP disminuyeron. El uso del BNP puede proporcionar precisión adicional a la evaluación de enfermería.

RESUMO Objetivo: Analisar o comportamento do peptídeo natriurético tipo B (BNP) na presença de características definidoras (CDs) do diagnóstico de enfermagem Excesso de volume de líquidos (00026) em pacientes hospitalizados por insuficiência cardíaca descompensada. Métodos: Estudo de coorte com pacientes internados com insuficiência cardíaca descompensada (setembro-2015 a setembro-2016), definida pelos Critérios de Boston. Pacientes hospitalizados por mais de 36 horas, valor de BNP ≥ 100 pg/ml foram incluídos; valores de BNP basal-final foram comparados pelo teste Wilcoxon; as CDs no basal-final foram comparadas pelo teste t pareado. Resultados: Sessenta e quatro pacientes foram incluídos; houve correlação positiva significativa entre o delta de BNP com o número de CDs presentes na avaliação clínica inicial. Conclusões: O comportamento do BNP foi correlacionado com as CDs, indicando congestão. Com a compensação clínica, as CDs e a concentração de BNP diminuíram. O uso deste biomarcador pode fornecer precisão adicional à avaliação de enfermagem.

Humans , Male , Female , Aged , Water-Electrolyte Imbalance/diagnosis , Nursing Diagnosis , Natriuretic Peptide, Brain/blood , Heart Failure/blood , Stroke Volume , Water-Electrolyte Imbalance/blood , Biomarkers/blood , Cohort Studies , Sample Size , Emergency Medical Services , Heart Failure/nursing , Heart Failure/physiopathology
Article in Korean | WPRIM (Western Pacific) | ID: wprim-811314


PURPOSE: To compare the accuracy of three intraocular lens (IOL) power calculation formulas (SRK/T, Barrett Universal II, and T2) in cataract surgery patients.METHODS: In total, 73 eyes of 73 patients who underwent uneventful cataract surgery were retrospectively reviewed. IOL power was determined using SRK/T, Barrett Universal II, and T2 preoperatively. The findings were compared with the actual refractive outcome to obtain the prediction error. The mean prediction error (ME) and mean absolute error (MAE) of each formula were compared. The MAE was defined as the difference between the postoperative spherical equivalence (SE) and the preoperatively predicted SE. The ME and MAE of each formula 3 months after surgery were compared with preoperatively predicted SE. Eyes were classified into subgroups based on axial length (AL) and average keratometry (K).RESULTS: The ME and MAE for the three formulas were SRK/T [−0.08 ± 0.45 diopters (D) and 0.35 ± 0.40 D, respectively], Barrett Universal II (−0.01 ± 0.44 D and 0.33 ± 0.30 D, respectively), and T2 (0.04 ± 0.45 D and −0.34 ± 0.30 D, respectively), but no statistically significant differences were detected. Similar results were obtained in groups with a long AL or a large average K. In groups with an AL ≥ 26 mm or with an average K ≥ 47 D, the Barrett Universal II formula yielded the smallest standard deviation and a ME closest to zero, but these differences were not statistically significant.CONCLUSIONS: No significant differences were observed between the three formulas regarding ME or MAE. However, recent formulas such as the Barrett Universal II could provide certain benefits in predicting IOL power for patients with a long AL (> 26 mm) or larger average K. Further research with a larger sample size is recommended for more evaluation.

Cataract , Humans , Lenses, Intraocular , Retrospective Studies , Sample Size
Article in English | WPRIM (Western Pacific) | ID: wprim-810964


BACKGROUND: Pulmonary hypertension (PH) is common in patients with idiopathic pulmonary fibrosis (IPF) and is associated with poor outcomes. This study was performed to determine the clinical efficacy of PH-specific therapeutic agents for IPF patients.METHODS: We performed a systematic review and meta-analysis using MEDLINE, EMBASE, and the Cochrane Central Register. We searched randomized controlled trials (RCTs) without language restriction until November 2018. The primary outcome was all-cause mortality to end of study.RESULTS: We analyzed 10 RCTs involving 2,124 patients, 1,274 of whom received PH-specific agents. In pooled estimates, the use of PH-specific agents was not significantly associated with reduced all-cause mortality to end of study compared with controls (hazard ratio, 0.99; 95% confidence interval [CI], 0.92, 1.06; P = 0.71; I² = 30%). When we performed subgroup analyses according to the type of PH-specific agent, sample size, age, forced vital capacity, diffusion lung capacity, and the extent of honeycombing, PH-specific agents also showed no significant association with a reduction in all-cause mortality. A small but significant improvement in quality of life, measured using the St. George Respiratory Questionnaire total score, was found in the PH-specific agent group (mean difference, −3.16 points; 95% CI, −5.34, −0.97; P = 0.005; I² = 0%). We found no significant changes from baseline in lung function, dyspnea, or exercise capacity. Serious adverse events were similar between the two groups.CONCLUSION: Although PH-specific agents provided small health-related quality-of-life benefits, our meta-analysis provides insufficient evidence to support their use in IPF patients.

Diffusion , Dyspnea , Humans , Hypertension, Pulmonary , Idiopathic Pulmonary Fibrosis , Lung , Lung Volume Measurements , Mortality , Quality of Life , Sample Size , Treatment Outcome , Vasodilator Agents , Vital Capacity
Prensa méd. argent ; 105(6): 361-369, Jul 2019. graf, tab
Article in Spanish | LILACS (Americas), BINACIS | ID: biblio-1023787


Influenza is a respiratory disease ocasionated by influenza virus A and B. Is a disease with high morbi-mortality world-wide. Influenza produces an acute febrile respiratory illness with cough, headache and myalgias for 3-4 days, with simptoms that may persist for as long as 2 weeks. There are three types of influenza virsuses: A, B and C, of whom the type a has a higher ability to originate pandemias and is subclassified according to their surface antigens: hemaglutinine (H) and neuraminidase (N). Of the capacity of mutation that has the influenza virus and the consequent expression of different proteins, can modify its virulence. The transmission route is through direct contact with secretetory repirations. The transmission route is through direct contact with secretetory repirations. The incubation period is scant, between 12-72 hs. The aim of this study was to compare the clinical characteristics demographicals and evolutive of pediatric patients hospitalized because by Influenze A: subtypes H1N1 (pdm2009) and H3N2. An observative study was performed, retrospective, using data of hospitalizations of children during the years 2016 and 2017 with influenza A confirmed by laboratory. The study also, aimed to evaluate if the viral subtype constitutes a factor of risk, independent for complicated hospitalization (admission to intensive care and/or development of complications) in hospitalized children. The results obtained in the study are detailed in the paper. In conclusion, both viral subtypes affected mainly to children with risk factors. The viral subtype H1N1 was related with higher severety in hospitalized children. is of most importance to perform preventive works, specially in vulnerable groups, offering a good cover of immunizations. The clinical parameters arae commented (AU)

Humans , Child , Comorbidity/trends , Epidemiologic Factors , Statistical Analysis , Retrospective Studies , Cohort Studies , Sample Size , Patient Selection , Influenza A Virus, H1N1 Subtype/pathogenicity , Influenza A Virus, H3N2 Subtype/pathogenicity , Influenza in Birds/complications , Risk Factors
Acta colomb. psicol ; 22(1): 202-215, ene.-jun. 2019. tab, graf
Article in Spanish | LILACS (Americas) | ID: biblio-989081


Resumen En el presente trabajo se evaluó el efecto de distintos tipos de entrenamiento sobre (a) la ejecución en pruebas de aprendizaje y transferencia, y (b) la elaboración de descripciones poscontacto en una tarea de discriminación condicional de segundo orden. Con este fin, se asignaron 16 participantes a cuatro grupos; la fase de entrenamiento para los grupos 1 y 3 consistió en la observación de una tarea de discriminación condicional de segundo orden en la que las respuestas de igualación fueron resaltadas con un marco rojo y se indicó, para cada ensayo, si eran acertadas o erróneas (entrenamiento observacional), mientras que para los participantes de los grupos 2 y 4 la tarea consistió en emitir una respuesta explícita de igualación ensayo por ensayo (entrenamiento instrumental). Adicionalmente, se le pidió a los participantes de los grupos 3 y 4 que realizaran una descripción de las contingencias enfrentadas cada doce ensayos, y al finalizar la tarea completa se le pidió a todos los participantes que elaboraran una descripción similar. Como resultado, los participantes de los grupos que estuvieron bajo entrenamiento observacional presentaron el mayor porcentaje de aciertos en las pruebas de aprendizaje y transferencia, además de que elaboraron descripciones poscontacto más específicas y pertinentes que los individuos de los grupos restantes. Estos resultados sugieren que el aprendizaje mediante la observación puede darse incluso si el observador no es expuesto directamente a la ejecución de la respuesta de otro individuo, es decir, aun cuando las respuestas reforzadas se presenten solo de manera gráfica.

Resumo Neste trabalho, foi avaliado o efeito de diferentes tipos de treinamento sobre a execução em testes de aprendizagem e transferência e a elaboração de descrições pós-contato numa tarefa de discriminação condicional de segunda ordem. Com esse objetivo, foram designados 16 participantes a quatro grupos. A fase de treinamento para os participantes dos grupos 1 e 3 consistiu na observação de uma tarefa de discriminação condicional de segunda ordem na qual as respostas de igualação foram ressaltadas com um sinal vermelho e foi indicado, para cada ensaio, se eram acertadas ou errôneas (treinamento observacional). Nessa mesma fase, para os participantes dos grupos 2 e 4, a tarefa consistiu em emitir uma resposta explícita de igualação ensaio por ensaio (treinamento instrumental). Além disso, foi pedido aos participantes dos grupos 3 e 4 que realizassem uma descrição das contingências enfrentadas a cada doze ensaios. Ao finalizar a tarefa, foi solicitado a todos os participantes que elaborassem uma descrição semelhante. Como resultado, os participantes dos grupos que estiveram sob o treinamento observacional apresentaram maior porcentagem de acertos nos testes de aprendizagem e transferência, e elaboraram descrições pós-contato mais específicas e pertinentes do que os indivíduos dos demais grupos. Esses resultados sugerem que a aprendizagem mediante a observação pode acontecer inclusive se o observador não for exposto diretamente à execução da resposta de outro indivíduo, isto é, ainda quando as respostas reforçadas forem apresentadas somente de maneira gráfica.

Abstract The effects of different types of training over a) performance on learning and transfer tasks, and b) generation of post-contact descriptions in a second order matching-to-sample task were assessed. 16 participants were randomly assigned to one of four experimental groups. During the training phase, the requirement for participants in groups 1 and 3 consisted of the observation of a conditional discrimination task in which matching responses were highlighted with a red frame and indicated, for each trial, whether they were right or wrong (observational training). During this same phase, the task for participants in groups 2 and 4 was to produce, trial by trial, an explicit matching response (instrumental training). Additionally, participants in groups 3 and 4 were required to write a description of the contingencies every twelve trials. After the task, all participants were requested to develop a similar description. Participants of groups that were under observational training had the highest percentage of correct answers on learning and transfer tests. Similarly, they produced more specific rules than individuals from other groups. These results suggest that learning by observation can occur even if the viewer is not directly exposed to responses of another individual, that is, even when reinforced responses are simply presented graphically.

Humans , Male , Female , Psychological Tests , Sample Size , Mentoring
Acta colomb. psicol ; 22(1): 248-260, ene.-jun. 2019. tab
Article in Spanish | LILACS (Americas) | ID: biblio-989083


Resumen En los últimos años se han desarrollado medidas breves de los cinco factores de personalidad, sin embargo, la ganancia práctica de tiempo provista por las formas breves puede implicar propiedades psicométricas más débiles de los instrumentos. En la construcción de escalas breves, para mantener propiedades psicométricas adecuadas se debe emplear criterios teóricos y empíricos en la selección de los ítems y minimizar los sesgos de respuesta, como el de la aquiescencia (AC), que hace referencia a la tendencia de las personas a estar de acuerdo con afirmaciones positivas independientemente del contenido de la afirmación. Teniendo esto en cuenta, el objetivo principal del presente estudio fue desarrollar un instrumento breve (30 ítems), de dominio público, para medir los cinco factores de personalidad en población latina, controlando el sesgo de respuesta AC. La muestra estuvo compuesta por 910 participantes, 543 de sexo femenino (59.6 %) y 367 de sexo masculino (40.3 %), con edades comprendidas entre los 15 y los 80 años (M = 29.52; DT = 12.25), pertenecientes a la ciudad de Córdoba, Argentina. Para el proceso de validación se propuso realizar un estudio de convergencia con las cinco escalas del NEO-FFI, un análisis de diferencia de grupos según el sexo y la edad de los participantes, y un estudio de validez predictiva respecto a algunas actividades recreacionales (uso de drogas, irresponsabilidad, amistad, erudición/creatividad y comunicación). Los resultados indican que el IPIP-R-30 presenta una estructura factorial de cinco factores, índices de confiabilidad adecuados tanto de consistencia interna como de estabilidad temporal, evidencia de validez convergente con las escalas del NEO-FFI, evidencia de diferencia de grupos según sexo y edad, y validez predictiva de la frecuencia de diferentes categorías de actividades específicas. De esta manera, se puede concluir que el IPIP-R-30 constituye una herramienta válida de evaluación de los rasgos de personalidad en nuestro medio, con puntuaciones libres del sesgo de AC.

Resumo Nos últimos anos, têm sido desenvolvidas medidas breves dos cinco fatores de personalidade; contudo, o ganho prático de tempo previsto pelas formas breves pode implicar propriedades psicométricas mais fracas dos instrumentos. Na construção de escalas breves, para manter propriedades psicométricas adequadas, devem ser empregados critérios teóricos e empíricos na seleção dos itens, e devem ser minimizados os vieses de resposta, como o da aquiescência (AC). Esse conceito faz referência à tendência das pessoas que estão de acordo com afirmações positivas, independentemente do conteúdo da afirmação. Nesse sentido, o objetivo principal deste estudo foi desenvolver um instrumento breve (30 itens), de domínio público, para medir os cinco fatores de personalidade em população latina, controlando o viés de resposta AC. A amostra esteve composta por 910 participantes, 543 de sexo feminino (59.6 %) e 367 de sexo masculino (40.3 %), entre 15 e 80 anos de idade (M = 29.52; DP = 12.25), pertencentes à cidade de Córdoba, Argentina. Para o processo de validação, foi proposto realizar um estudo de convergência com as cinco escalas do NEO-FFI, uma análise de diferença de grupos segundo o sexo e idade dos participantes, e um estudo de validade preditiva a respeito de atividades recreativas (uso de drogas, irresponsabilidade, amizade, erudição/ criatividade e comunicação). Os resultados indicam que o IPIP-R-30 apresenta uma estrutura fatorial de cinco fatores, índices de confiabilidade adequados tanto de consistência interna quanto de estabilidade temporal, evidência de validade convergente com as escalas do NEO-FFI, evidência de diferença de grupos segundo sexo e idade, e validade preditiva da frequência de diferentes categorias de atividades específicas. Dessa maneira, pode-se concluir que o IPIP-R-30 constitui uma ferramenta válida de avaliação dos traços de personalidade em nosso meio, com pontuações livros do viés de AC.

Abstract In recent years, brief measures of the five personality factors have been developed; however, the practical gain of time provided by the brief versions may imply weaker psychometric properties of the instruments. To maintain adequate psychometric properties in the construction of brief scales, theoretical and empirical criteria should be used in the selection of items, and response biases such as acquiescence (AC) should be minimized. The term AC refers to people's tendency to agree with positive statements, regardless of their content. The main purpose of the present study is to develop a brief public domain instrument (30 items) to measure the five personality factors in the Latin American population, controlling the AC response bias. The sample consisted of 910 participants, 543 women (59.6 %) and 367 men (40.3 %), age range 15-80 years (M = 29.52; DT = 12.25) from the city of Córdoba, Argentina. For the validation process, a convergence study with the five NEO-FFI scales, an analysis of group differences according to the participants' sex and age, and a predictive validity study regarding recreational activities (drug use, irresponsibility, friendship, erudition/creativity, and communication) were performed. The results indicate that the IPIP-R-30 presents a five-factor factorial structure, adequate reliability indices of both internal consistency and temporal stability, evidence of convergent validity with the NEO-FFI scales, evidence of group differences as regards sex and age, and frequency predictive validity of different categories of specific activities. Thus, it can be concluded that the IPP-R-30 is a valid tool for assessing personality factors in our environment, with scores free of AC bias.

Humans , Male , Female , Personality , Psychological Tests , Sample Size
Article in English | WPRIM (Western Pacific) | ID: wprim-765162


BACKGROUND: This study aimed to evaluate the current overall preventable trauma death rate (PTDR) in Korea and identify factors associated with preventable trauma death (PTD). METHODS: The target sample size for review was designed to be 1,131 deaths in 60 emergency medical institutions nationwide. The panels for the review comprised trauma specialists working at the regional trauma centers (RTCs); a total of 10 teams were formed. The PTDR and factors associated with PTD were analyzed statistically. RESULTS: Of the target cases, 943 were able to undergo panel review and be analyzed statistically. The PTDR was 30.5% (6.1% preventable and 24.4% possibly preventable). Those treated at a RTC showed a significantly lower PTDR than did those who were not (21.9% vs. 33.9%; P = 0.002). The PTDR was higher when patients were transferred from other hospitals than when they directly visited the last hospital (58.9% vs. 28.4%; P = 0.058; borderline significant). The PTDR increased gradually as the time from accident to death increased; a time of more than one day had a PTDR 14.99 times higher than when transferred within one hour (95% confidence interval, 4.68 to 47.98). CONCLUSION: Although the PTDR in Korea is still high compared to that in developed countries, it was lower when the time spent from the accident to the death was shorter and the final destined institution was the RTC. To reduce PTDR, it is necessary to make an effort to transfer trauma patients to RTCs directly within an appropriate time.

Developed Countries , Emergencies , Humans , Korea , Mortality , Sample Size , Specialization , Trauma Centers , Wounds and Injuries
Article in English | WPRIM (Western Pacific) | ID: wprim-765106


BACKGROUND: We evaluated the effects of neurofeedback as an augmentation treatment on depressive symptoms and functional recovery in patients with treatment-resistant depression (TRD). METHODS: We included 24 adult patients with TRD and 12 healthy adults. 24 TRD patients were assigned to the neurofeedback augmentation group (n = 12) and the medication-only (treatment as usual [TAU]) group (n = 12). The neurofeedback augmentation group underwent combined therapy comprising medication and 12–24 sessions of neurofeedback training for 12 weeks. To assess the serum levels of brain-derived neurotrophic factor (BDNF) in both groups, pre- and post-treatment blood samples were obtained. Patients were evaluated using the Hamilton Depression Rating Scale (HAM-D), Beck Depression Inventory (BDI), Clinical Global Impression-Severity (CGI-S), 5-level version of European Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D-5L), and Sheehan Disability Scale (SDS) at baseline, and at the 1-, 4-, and 12-week. RESULTS: From baseline to week 12, neurofeedback training reduced mean scores on HAM-D, BDI-II, CGI-S, and SDS, and increased mean EQ-5D-5L tariff score. In the neurofeedback augmentation group, the response and remission rates were 58.3% and 50.0%, respectively, at week 12. Changes in HAM-D, EQ-5D-5L tariff score, and SDS were significantly larger in the neurofeedback group than in the medication-only (TAU) group. No significant difference in BDNF level was found pre- vs. post-treatment in any of the groups. CONCLUSION: Despite the small sample size, these results suggest that neurofeedback treatment may be effective as an augmentation treatment, not only for depressive symptoms, but also for functional recovery, in patients with TRD. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0004183 Identifier: NCT04078438

Adult , Brain-Derived Neurotrophic Factor , Classification , Depression , Depressive Disorder, Major , Humans , Information Services , Neurofeedback , Pilot Projects , Quality of Life , Sample Size
Article in English | WPRIM (Western Pacific) | ID: wprim-764522


OBJECTIVE: This study aims to evaluate the effects and pregnancy outcomes of gonadotropin-releasing hormone agonist (GnRH agonist) combined with aromatase inhibitor (AI) in preserving the fertility of obese women with grade 1 endometrial cancer (EC). METHODS: This study recruited obese EC patients who wished to preserve their fertility. The treatment regimen consisted of intramuscular GnRH agonist 3.75 mg every 4 weeks and oral AI 2.5 mg daily. The maintenance regimen was the same as the initial treatment regimen. Primary outcomes included response rate, time to complete response (CR), and time to recurrence; pregnancy outcomes included the time to pregnancy, pregnancy rate and live birth rate. RESULTS: Six obese patients with EC were included in this study, with the age (mean±standard deviation [SD]) of 30.5±3.3 years and body mass index (mean±SD) of 35.0±1.4 kg/m2. CR rate was 100%, and time to CR was 3–6 months. None of the patients had recurrence after a median follow-up of 4.0 years (range, 1.3–7.0 years). The most common side effects were menopause-like symptoms. Among these patients, no weight gain was observed during treatment. The pregnancy rate and live birth rate was 50.0% and 75.0%, respectively, with a median time to pregnancy of 2.4 years (range, 1.0–5.5 years). CONCLUSION: The combination of GnRH agonist and AI demonstrated promising long-term effect in young obese EC patients who wished to preserve their fertility. No weight gain side effects were observed. Further studies with a larger sample size are needed to fully evaluate this novel treatment regimen.

Aromatase Inhibitors , Aromatase , Body Mass Index , Endometrial Neoplasms , Female , Fertility , Follow-Up Studies , Gonadotropin-Releasing Hormone , Humans , Live Birth , Obesity , Organ Sparing Treatments , Pilot Projects , Pregnancy , Pregnancy Outcome , Pregnancy Rate , Recurrence , Sample Size , Time-to-Pregnancy , Weight Gain
Journal of Gastric Cancer ; : 157-164, 2019.
Article in English | WPRIM (Western Pacific) | ID: wprim-764491


PURPOSE: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. MATERIALS AND METHODS: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. CONCLUSIONS: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection. TRIAL REGISTRATION: Identifier: NCT03123042

Feasibility Studies , Gastrectomy , Humans , Indocyanine Green , Lymph Node Excision , Lymph Nodes , Neoplasm Metastasis , Neoplasm, Residual , Optical Imaging , Postoperative Complications , Prospective Studies , Research Personnel , Sample Size , Stomach Neoplasms
Article in English | WPRIM (Western Pacific) | ID: wprim-764225


BACKGROUND AND OBJECTIVES: Many studies have reported no benefit of sound localization, but improved speech understanding in noise after treating patients with single-sided deafness (SSD). Furthermore, their performances provided a large individual difference. The present study aimed to measure the ability of speech perception and gap detection in noise for the SSD patients to better understand their hearing nature.

Deafness , Hearing , Hearing Loss , Hearing Loss, Conductive , Humans , Individuality , Noise , Plastics , Sample Size , Signal-To-Noise Ratio , Silver Sulfadiazine , Sound Localization , Speech Perception , Young Adult
Article in English | WPRIM (Western Pacific) | ID: wprim-763792


Athletic performance is a complex multifactorial trait involving genetic and environmental factors. The heritability of an athlete status was reported to be about 70% in a twin study, and at least 155 genetic markers are known to be related with athlete status. Mitochondrial DNA (mtDNA) encodes essential proteins for oxidative phosphorylation, which is related to aerobic capacity. Thus, mtDNA is a candidate marker for determining physical performance. Recent studies have suggested that polymorphisms of mtDNA are associated with athlete status and/or physical performance in various populations. Therefore, we analyzed mtDNA haplogroups to assess their association with the physical performance of Korean population. The 20 mtDNA haplogroups were determined using the SNaPshot assay. Our result showed a significant association of the haplogroup F with athlete status (odds ratio, 3.04; 95% confidence interval, 1.094 to 8.464; p = 0.012). Athletes with haplogroup F (60.64 ± 3.04) also demonstrated a higher Sargent jump than athletes with other haplogroups (54.28 ± 1.23) (p = 0.041). Thus, our data imply that haplogroup F may play a crucial role in the physical performance of Korean athletes. Functional studies with larger sample sizes are necessary to further substantiate these findings.

Athletes , Athletic Performance , DNA, Mitochondrial , Genetic Markers , Humans , Oxidative Phosphorylation , Sample Size
Epidemiology and Health ; : e2019030-2019.
Article in English | WPRIM (Western Pacific) | ID: wprim-763733


OBJECTIVES: Depression, which is the most common comorbidity in breast cancer (BC) patients, has adverse effects on patients' quality of life, disease progress, and survival. METHODS: The protocol of this study was registered in PROSPERO (registration No. CRD42019121494). We electronically searched published studies through January 2019 with the aim of finding articles that investigated the prevalence of depression among BC survivors. Web of Science, Scopus, PubMed/MEDLINE, Science Direct, and Google Scholar were searched to obtain relevant published studies. This review included 14 cross-sectional and 4 cohort studies published from 2000 to 2018. We used a random-effects model to conduct the meta-analysis and generated a summary estimate for the pooled prevalence with 95% confidence intervals (CIs). A subgroup analysis was also conducted based on the depression assessment tool used and the study design. RESULTS: The total sample size of the studies contained 2,799 women with BC, including 1,228 women who were diagnosed with depression. The pooled prevalence of depression among Iranian women with BC was 46.83% (95% CI, 33.77 to 59.88) with significant heterogeneity (I² =98.5%; p<0.001). The prevalence of depression ranged from 14.00% (95% CI, 4.91 to 23.09) to 95.90% (95% CI, 91.97 to 99.83). The results of the subgroup analyses suggested that the depression assessment tool, year of publication, and study design were sources of heterogeneity. CONCLUSIONS: Our findings indicate a high prevalence of depression among BC patients, underscoring the urgent need for clinicians and health authorities to provide well-defined social and psychological supportive care programs for these patients.

Breast Neoplasms , Breast , Cohort Studies , Comorbidity , Depression , Female , Humans , Iran , Population Characteristics , Prevalence , Publications , Quality of Life , Sample Size , Survivors
Article in English | WPRIM (Western Pacific) | ID: wprim-763725


This study investigated the social outcomes of the Environmental Health Studies of National Industrial Complex (EHSNIC), which have been conducted by the National Institute of Environmental Research (NIER) in eight National Industrial Complex Areas (NICAs) since 2003. Eighteen sessions of focus-group interviews with 85 people were conducted from October 2016 to January 2017. Interviewees were stakeholders from eight NICAs and included resident representatives, environmental nongovernment organizations, local government officials, and environmental health and safety officers from companies. Interview results were divided into six categories: EHSNIC awareness, EHSNIC outcomes, EHSNIC limitations, EHSNIC continuation, EHSNIC improvement directions, and EHSNIC results use. They were then further indexed into 23 divisions. EHSNIC awareness varied across stakeholders. A major EHSNIC outcome is that a continued result database was established, which was used as a reference for environmental improvements. EHSNIC limitations included no proper healthcare actions taken during the EHSNIC study period, a lack of EHSNIC results disclosure, a failure to reflect local specificity, and a lack of validity in the results. Regarding EHSNIC continuation, all stakeholders said EHSNIC should be conducted continuously. EHSNIC improvement directions included conducting studies tailored to each NICA, identifying correlations between pollutant exposure and disease, increasing the sample size, and performing repeated studies. Regarding EHSNIC results use, respondents wanted to use the results as a reference to relocate residents, ensure distance between NICAs and residential areas, provide healthcare support, develop local government policies, and implement firms’ environmental controls. Since EHSNIC aims to identify the health effects of NICAs on residents and take appropriate actions, it should be continued in the future. Even during the study period, it is important to take steps to preventively protect residents’ health. EHSNIC also needs to reflect each NICA’s characteristics and conduct reliable research based on stakeholder participation and communication.

Delivery of Health Care , Disclosure , Environmental Health , Local Government , Qualitative Research , Sample Size , Sensitivity and Specificity , Surveys and Questionnaires
Article in English | WPRIM (Western Pacific) | ID: wprim-763700


BACKGROUND: Although previous studies have demonstrated that irisin plays an anti-inflammatory role in the body, conflicting results have been reported regarding the correlation between serum levels of irisin and C-reactive protein (CRP). The present meta-analysis was conducted to further investigate the correlation between irisin and CRP levels. METHODS: We systematically searched PubMed, the Cochrane Library, Web of Science, Embase, SCOPUS, and Ovid to retrieve studies assessing the correlation between irisin and CRP levels. Meta-analyses were performed using a random-effects model, and the I 2 index was used to evaluate heterogeneity. RESULTS: Of the 428 studies that were initially found, 14 studies with 2,530 participants met the inclusion criteria for the meta-analysis. The pooled effect size was calculated as 0.052 (95% confidence interval, −0.047 to 0.152; P=0.302). Subgroup analyses identified s ignificant, positive, but weak correlations between CRP and irisin levels in cohort studies, studies conducted among healthy participants, studies in which the male-to-female ratio was less than 1, in overweight or obese subjects, and in studies with a sample size of at least 100 participants. CONCLUSION: The present meta-analysis found no overall significant correlation between irisin and CRP levels, although a significant positive correlation was found in overweight or obese subjects. Well-designed studies are needed to verify the results of the present meta-analysis.

C-Reactive Protein , Cohort Studies , Healthy Volunteers , Overweight , Population Characteristics , Sample Size
Article in English | WPRIM (Western Pacific) | ID: wprim-763602


BACKGROUND: Prophylactic pinning of the uninvolved side after unilateral slipped capital femoral epiphysis (SCFE) is controversial. The alpha angle, a measurement of femoral head-neck aspherity, was proposed as a predictor of progression of contralateral SCFE with a treatment threshold of greater than 50.5°. The aim of this study was to evaluate its validity in our cohort of patients. METHODS: A retrospective review of a 10-year series of patients who presented with unilateral SCFE was conducted. Minimum follow-up duration to identify contralateral progression was 18 months. Age, sex, ethnicity, and endocrinopathies were noted. Alpha angle measurements of the unaffected hip were performed by two independent observers. The average values of measurements were used for analysis. Univariate and multivariate logistic regression analyses were performed to identify predictors of contralateral progression. A receiver operating characteristic (ROC) curve was generated. RESULTS: There were 43 patients with unilateral SCFE. Seven patients (16.3%) developed contralateral SCFE. There were 31 males (72.1%) and 12 females (27.9%). The mean duration from index surgery to contralateral fixation was 43.9 weeks (range, 16.2 to 77 weeks). The mean alpha angle was significantly higher in the patients with contralateral progression (mean, 50.7°; standard deviation [SD], 5.4°; range, 43.8° to 58.5°) than in the patients without progression (mean, 43.0°; SD, 4.2°; range, 33.0° to 52.5°; p < 0.001). The alpha angle was also identified as a statistically significant predictor of contralateral progression on multivariate analysis (p = 0.02). The intraclass correlation coefficient for interobserver reliability was moderately strong at 0.76 (95% confidence interval, 0.55 to 0.87). The area under the ROC curve was 0.88. The treatment threshold of 50.5° had a sensitivity of 0.43, specificity of 0.94, and number needed to treat (NNT) of 2.7. The ideal treatment threshold derived from the ROC curve was 49.0°, which had a sensitivity of 0.71, specificity of 0.89, and an NNT of 1.7. CONCLUSIONS: Alpha angle is a potential predictor of contralateral hip involvement in children with SCFE who may benefit from prophylactic hip fixation. Results from our series suggest a treatment threshold be 49.0°. However, given the limited sample size and moderately strong interobserver reliability, larger studies are needed to validate our findings.

Asian Continental Ancestry Group , Child , Cohort Studies , Female , Follow-Up Studies , Hip , Humans , Logistic Models , Male , Multivariate Analysis , Retrospective Studies , ROC Curve , Sample Size , Sensitivity and Specificity , Slipped Capital Femoral Epiphyses
Article in English | WPRIM (Western Pacific) | ID: wprim-773365


OBJECTIVE@#To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes.@*METHODS@#The power functions of the Fieller-type confidence interval and the asymptotic confidence interval in crossover designs with serial-sampling data are here derived. Simulation studies were conducted to evaluate the derived power functions.@*RESULTS@#Simulation studies show that two power functions can provide precise power estimates when normality assumptions are satisfied and yield conservative estimates of power in cases when data are log-normally distributed. The intra-correlation showed a positive correlation with the power of the bioequivalence test. When the expected ratio of the AUCs was less than or equal to 1, the power of the Fieller-type confidence interval was larger than the asymptotic confidence interval. If the expected ratio of the AUCs was larger than 1, the asymptotic confidence interval had greater power. Sample size can be calculated through numerical iteration with the derived power functions.@*CONCLUSION@#The Fieller-type power function and the asymptotic power function can be used to determine sample sizes of crossover trials for bioequivalence assessment of topical ophthalmic drugs.

Administration, Topical , Clinical Trials as Topic , Methods , Cross-Over Studies , Humans , Models, Theoretical , Ophthalmic Solutions , Pharmacokinetics , Sample Size , Therapeutic Equivalency