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1.
Qual Life Res ; 33(4): 1015-1028, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38233697

RESUMO

PURPOSE: This study aimed to investigate the distinct yet interconnected aspects of social isolation, namely living alone and loneliness, and their individual and combined effects on predicting health-related quality of life (HRQoL). METHODS: A comprehensive analysis, encompassing both cross-sectional and longitudinal approaches, was conducted using a nationally representative sample of 5644 community-dwelling adults aged 55 and older from the Healthy Aging Longitudinal Study in Taiwan (HALST). RESULTS: Baseline data revealed that 9% of the sample reported living alone, while 10.3% reported experiencing loneliness, with 2.5% reporting both living alone and feeling lonely. Regression analyses consistently demonstrated that loneliness was significantly associated with concurrent and subsequent lower physical (PCS) and mental (MCS) component of HRQoL. Conversely, additional analyses indicated that living alone could indirectly exacerbate the adverse effects of loneliness or contribute to prolonged feelings of loneliness, subsequently predicting lower HRQoL after 3.2 year. CONCLUSION: In terms of practical implications, interventions and policies aiming to enhance HRQoL in older adults should give particular attention to those who report feelings of loneliness, especially individuals living alone.


Assuntos
Envelhecimento Saudável , Solidão , Humanos , Idoso , Qualidade de Vida/psicologia , Estudos Longitudinais , Taiwan , Estudos Transversais , Ambiente Domiciliar
2.
BMC Urol ; 24(1): 139, 2024 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-38965501

RESUMO

BACKGROUND: An intravesical gas explosion is a rare complication of transurethral resection of the prostate (TURP). It was first reported in English literature in 1926, and up to 2022 were only forty-one cases. Injury from an intravesical gas explosion, in the most severe cases appearing as extraperitoneal or intraperitoneal bladder rupture needed emergent repair surgery. CASE PRESENTATION: We present a case of a 75-year-old man who suffered an intravesical gas explosion during TURP. The patient underwent an emergent exploratory laparotomy for bladder repair and was transferred to the intensive care unit for further observation and treatment. Under the medical team's care for up to sixty days, the patient recovered smoothly without clinical sequelae. CONCLUSIONS: This case report presents an example of a rare complication of intravesical gas explosion during TURP, utilizing root cause analysis (RCA) to comprehend causal relationships and team strategies and tools to improve performance and patient safety (TeamSTEPPS) method delivers four teamwork skills that can be utilized during surgery and five recommendations to avoid gas explosions during TURP to prevent the recurrence of medical errors. In modern healthcare systems, promoting patient safety is crucial. Once complications appear, RCA and TeamSTEPPS are helpful means to support the healthcare team reflect and improve as a team.


Assuntos
Explosões , Análise de Causa Fundamental , Ressecção Transuretral da Próstata , Bexiga Urinária , Humanos , Masculino , Idoso , Ressecção Transuretral da Próstata/efeitos adversos , Bexiga Urinária/cirurgia , Bexiga Urinária/lesões , Gases , Equipe de Assistência ao Paciente , Complicações Intraoperatórias/etiologia
3.
Appetite ; 194: 107199, 2024 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-38160733

RESUMO

Although depression has been linked to the habit of consuming sugar-sweetened beverages (SSBs), little is known about their long-term relationships and the mediating role of sleep problems. This study examines the associations between childhood depressive symptoms trajectories and adolescent SSB-habit trajectories and whether these associations were mediated by sleep problems. Data came from 1560 adolescents participating in a longitudinal study across grades 1 through 12 in northern Taiwan. Group-based trajectory modeling was used to identify development of childhood depressive symptoms and an SSB habit in adolescence. Multinomial logistic regression was conducted to examine the influence of childhood depressive symptoms and adolescent SSB habit. Mediation analysis was conducted to test whether sleep problems mediated the associations examined. Four distinct trajectories of childhood depressive symptoms were identified: low-stable (30.79%), moderate-stable (42.32%), increasing (12.29%), and high-stable (11.60%). Three distinct trajectories of SSB habit in adolescence were identified: low-stable (44.32%), increasing (15.02%), and high-stable (40.65%). Children who had moderate-stable (aOR = 1.35; CI: 1.04-1.77), high-stable (aOR = 2.01; CI: 1.28-3.15), or increasing (aOR = 1.97; CI: 1.26-3.06) trajectories of depressive symptoms relative to those in the low-stable group were significantly more likely to belong to the high-stable trajectory of SSBs than to the low-stable SSBs group. The Z-mediation test showed that sleep problems significantly mediated the associations between trajectories of childhood depressive symptoms and trajectories of SSBs during adolescence (all p < 0.05). Childhood depressive symptoms conferred risks for adolescent SSB habits; and the effects were seen, in part, through increasing sleep problems.


Assuntos
Transtornos do Sono-Vigília , Bebidas Adoçadas com Açúcar , Criança , Humanos , Adolescente , Depressão , Bebidas Adoçadas com Açúcar/efeitos adversos , Estudos Longitudinais , Hábitos , Transtornos do Sono-Vigília/epidemiologia , Transtornos do Sono-Vigília/etiologia , Bebidas
4.
Ecotoxicol Environ Saf ; 282: 116688, 2024 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-38971102

RESUMO

Long-term exposure to ambient PM2.5 is known associated with cardiovascular and respiratory health effects. However, the heterogeneous concentrationresponse function (CRF) between PM2.5 exposure across different concentration range and cardiopulmonary disease and diabetes mellitus (DM) incidence, and their implications on attributable years lived with disability (YLD) and regulation policy has not been well-studied. In this retrospective longitudinal cohort study, disease-free participants (approximately 170,000 individuals, aged ≥ 30 years) from the MJ Health Database were followed up (2007-2017) regarding incidents of coronary heart disease (CHD), ischemic stroke, chronic obstructive pulmonary disease (COPD), lower respiratory tract infections (LRIs), and DM. We used a time-dependent nonlinear weight-transformation Cox regression model for the CRF with an address-matched 3-year mean PM2.5 exposure estimate. Town/district-specific PM2.5-attributable YLD were calculated by multiplying the disease incidence rate, population attributable fraction, disability weight, and sex-age group specific subpopulation for each disease separately. The estimated CRFs for cardiopulmonary diseases were heterogeneously with the hazard ratios (HRs) increased rapidly for CHD and ischemic stroke at PM2.5 concentration lower than 10 µg/m3, whereas the HRs for DM (LRIs) increased with PM2.5 higher than 15 (20) µg/m3. Women had higher HRs for ischemic stroke and DM but not CHD. Relative to the lowest observed PM2.5 concentration of 6 µg/m3 of the study population, the PM2.5 level with an extra risk of 0.1 % (comparable to the disease incidence) for CHD, ischemic stroke, DM, and LRIs were 8.59, 11.85, 22.09, and 24.23 µg/m3, respectively. The associated attributable YLD decreased by 51.4 % with LRIs reduced most (83.6 %), followed by DM (63.7 %) as a result of PM2.5 concentration reduction from 26.10 to 16.82 µg/m3 during 2011-2019 in Taiwan. The proportion of YLD due to CHD and ischemic stroke remained dominant (56.4 %-69.9 %). The cost-benefit analysis for the tradeoff between avoidable YLD and mitigation cost suggested an optimal PM2.5 exposure level at 12 µg/m3. CRFs for cardiopulmonary diseases, attributable YLD, and regulation level, may vary depending on the national/regional background and spatial distribution of PM2.5 concentrations, as well as demographic characteristics.

5.
Eur Child Adolesc Psychiatry ; 33(1): 179-191, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36752940

RESUMO

Late chronotype during adolescence is a critical risk factor for poor physical and mental health among adolescents. While social loneliness is confirmed to negatively influence sleep behaviors, the long-term effect of social loneliness on chronotype remains unknown. This study aims to investigate whether social loneliness trajectories from middle childhood to adolescence are associated with chronotype in late adolescence and examine the potential sex differences in these associations. Data were obtained from 2398 adolescents who participated in the Child and Adolescent Behaviors in Long-Term Evolution project. Chronotype was calculated as the midpoint of sleep on free days adjusted for sleep debt. Group-based trajectory modeling and multiple linear regression were employed to establish social loneliness trajectories and determine their associations with chronotype. Social loneliness trajectories were significantly associated with chronotype and varied by sex. Specifically, boys following a high-decreasing trajectory had earlier chronotype during late adolescence than did those following a low-decreasing trajectory (B = - 0.07; p < 0.05). By contrast, girls following a low-to-moderate-increasing trajectory exhibited later chronotype than did those following a low-stable trajectory (B = 0.07; p < 0.01). Social loneliness trajectories, especially those displaying significant fluctuations over time, are critical indicators influencing chronotype among adolescents. Furthermore, these trajectories and their associations with chronotype display sex differences. These findings highlight the need for early interventions for psychological factors such as social loneliness to ensure that the late chronotype can be prevented. In addition, sex variations must be considered.


Assuntos
Comportamento do Adolescente , Cronotipo , Humanos , Masculino , Criança , Adolescente , Feminino , Solidão/psicologia , Sono , Comportamento do Adolescente/psicologia , Fatores de Risco
6.
J Nutr ; 153(6): 1783-1792, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37084871

RESUMO

BACKGROUND: Dietary patterns related to inflammation have become a focus of disease prevention but the patterns may vary among populations. OBJECTIVES: The study was conducted to determine Taiwanese dietary inflammatory patterns and evaluate their associations with biomarkers of lipid and glucose. METHODS: Data were taken from 5664 community-dwelling individuals aged ≥55 y recruited in 2009-2013 in the Healthy Aging Longitudinal Study in Taiwan (HALST). Dietary data were obtained from an FFQ. An empirical dietary inflammatory pattern (EDIP) was derived from reduced rank regression models that explained the serum high-sensitivity CRP, plasma IL-6, and TNF receptor 1. Cross-sectional associations between dietary scores and biomarkers of total cholesterol (TC); HDL cholesterol; LDL cholesterol; TG; and ratios of TG/HDL cholesterol, TG/TC, fasting glucose, insulin, and HbA1c were analyzed via multiple linear regression and adjusted for major confounders. The false-discovery rate (FDR)-adjusted P < 0.05 was considered statistically significant. Abdominal obesity was defined as a waist circumference of ≥90 cm for men and ≥80 cm for women. RESULTS: Higher EDIP-HALST scores were associated with higher TG (per score increment: 1.62%, 95% CI: 0.58%, 2.76%; PFDR = 0.01), TG/HDL cholesterol (2.01%, 95% CI: 0.67%, 3.37%; PFDR = 0.01), and TG/TC (1.42%, 95% CI: 0.41%, 2.43%; PFDR = 0.01) and nonlinearly associated with insulin, with those in the middle tertile had the highest serum insulin concentrations (means: 5.12 µIU/mL, 95% CI: 4.78, 5.78; PFDR = 0.04) in men, but not in women. No heterogeneity was detected between sexes. The associations with TG (1.23%, 95% CI: 0.19, 2.23%; Ptrend = 0.02), TG/HDL cholesterol (1.62%, 95% CI: 0.30%, 2.96%; Ptrend = 0.02), and TG/TC (1.11%, 95% CI: 0.11%, 2.13%; Ptrend = 0.03) were stronger in participants with abdominal obesity, but were borderline associated in participants with normal abdominal circumferences (all Ptrend = 0.05). CONCLUSIONS: Inflammatory diets, as measured via EDIP-HALST, are associated with serum TG concentration, particularly in participants with abdominal obesity. These findings may suggest that developing disease prevention strategies using dietary inflammatory patterns may be different by populations. J Nutr 20xx;x:xx.


Assuntos
Insulina , Obesidade Abdominal , Masculino , Humanos , Adulto , Feminino , HDL-Colesterol , Estudos Longitudinais , Taiwan , Estudos Transversais , Obesidade , Insulina Regular Humana , Biomarcadores , Glucose , Triglicerídeos
7.
Am J Geriatr Psychiatry ; 31(6): 438-448, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36858927

RESUMO

BACKGROUND: Insomnia and frailty are prevalent in older adults. This study aimed to elucidate the impact of insomnia and sedative-hypnotic use on the frailty rate over time. METHODS: We used data from community-dwelling older adults (mean ± SD age = 69.4 ± 8.2 years) from the Healthy Aging Longitudinal Study in Taiwan (HALST). A total of 4,744 participants were included in the study and were followed up for an average of 3.2 years. Frailty was assessed using the Fried criteria. Self-reported sleep problems, sedative-hypnotic use, and claims records from the National Health Insurance database were used. The generalized equation estimation (GEE) approach was applied to account for correlations between repeated measures. The average impact of insomnia and drug use on frailty over time was estimated by adjusting for potential confounding factors using the logic link in the GEE approach. RESULTS: The adjusted odds ratio (OR) of frailty was 1.41 (95% CI: [1.16, 1.72], Z-test statistics Z = 3.39, p <0.001) for insomnia and 1.52 ([1.16, 2.00], Z = 3.00, p = 0.0027) for sedative-hypnotic use. Interactions between insomnia and sedative-hypnotic use with frailty were not statistically significant. Long sleep duration > 8 hours, daytime sleepiness, and sleep apnea was also associated with an increased likelihood of developing frailty. Notably, a dose-response relationship between sedative-hypnotic drug use and frailty was observed. CONCLUSIONS: Insomnia and sedative-hypnotic use were independently associated with increased frailty. The implementation of nonpharmacological treatments to attenuate insomnia may reduce frailty rates.


Assuntos
Fragilidade , Distúrbios do Início e da Manutenção do Sono , Humanos , Idoso , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Fragilidade/epidemiologia , Estudos Longitudinais , Hipnóticos e Sedativos/efeitos adversos , Sono
8.
BMC Public Health ; 23(1): 871, 2023 05 12.
Artigo em Inglês | MEDLINE | ID: mdl-37170104

RESUMO

BACKGROUND: This study aimed to explore trends, in 3 periods, in the intake of energy and macronutrients among Taiwanese older adults. METHODS: Study subjects were those aged ≥65 years in the Nutrition and Health Survey in Taiwan 1999-2000 as well as the surveys in 2005-2008 and 2013-2016. Twenty-four-hour dietary recall data were obtained. This study used the 3 nutrition survey datasets for 1999-2000, 2005-2008, and 2013-2016, including data on the questionnaire, physical examination, and dietary intakes. Each nutrition survey involved the face-to-face household interview, and individual's dietary intake of carbohydrate, fat, and protein (% of energy) was estimated. Subsequently, intake statuses of the three macronutrients were classified into below, meeting, and above intake categories. RESULTS: In the 2013-2016 survey, approximately 40% of the older adults had a low intake of energy. The prevalence of older adults with a meeting intake of carbohydrate, fat, and protein have increased from the 1999-2000 to 2013-2016 periods. The prevalence of people having a low intake of carbohydrate declined from the 1999-2000 period to the 2013-2016 period. The prevalence of high fat intake in 2013-2016 was approximately 5% higher than that in 1999-2000. In the 2013-2016 period, the prevalence of low intake of carbohydrate, fat, and protein were 25.9, 24.5, and 4.9%, respectively; moreover, the prevalence of high intake of the aforementioned macronutrients were 38.7, 36.2, and 17.6%, respectively. CONCLUSIONS: Our study provides important evidence on the dietary patterns, as well as their changes over time among Taiwanese older adults. Such information would be useful for health policy makers about the burden of unbalanced diet and for nutrition educators on planning nutrition promotion interventions about well-balanced dietary for the older persons.


Assuntos
Carboidratos da Dieta , Ingestão de Energia , Humanos , Idoso , Idoso de 80 Anos ou mais , Gorduras na Dieta , Proteínas Alimentares , Dieta , Ingestão de Alimentos , Inquéritos Nutricionais
9.
Int Psychogeriatr ; 34(1): 61-70, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34275507

RESUMO

OBJECTIVES: To estimate the risks of depressive symptoms for developing frailty, accounting for baseline robust or pre-frailty status. DESIGN: An incident cohort study design. SETTING: Community dwellers aged 55 years and above from urban and rural areas in seven regions in Taiwan. PARTICIPANTS: A total of 2,717 participants from the Healthy Aging Longitudinal Study in Taiwan (HALST) were included. Subjects with frailty at baseline were excluded. The average follow-up period was 5.9 years. MEASUREMENTS: Depressive symptoms were measured by the 20-item Center for Epidemiological Studies Depression (CES-D) Scale. Frailty was assessed using the Fried frailty measurement. Participants were stratified by baseline robust or pre-frailty status to reduce the confounding effects of the shared criteria between depressive symptoms and frailty. Overall and stratified survival analyses were conducted to assess risks of developing frailty as a result of baseline depressive symptoms. RESULTS: One hundred individuals (3.7%) had depressive symptoms at baseline. Twenty-seven individuals (27.0%) with depressive symptoms developed frailty, whereas only 305 out of the 2,617 participants (11.7%) without depressive symptoms developed frailty during the follow-up period. After adjusting for covariates, depressive symptoms were associated with a 2.6-fold (95% CI 1.6, 4.2) increased hazard of incident frailty. The patterns of increased hazard were also observed when further stratified by baseline robust or pre-frailty status. CONCLUSIONS: Depressive symptoms increased the risk of developing frailty among the older Asian population. The impact of late-life depressive symptoms on physical health was notable. These findings also replicated results from Western populations. Future policies on geriatric public health need to focus more on treatment and intervention against geriatric depressive symptoms to prevent incident frailty among older population.


Assuntos
Fragilidade , Idoso , Estudos de Coortes , Depressão/diagnóstico , Depressão/epidemiologia , Idoso Fragilizado , Fragilidade/diagnóstico , Fragilidade/epidemiologia , Avaliação Geriátrica/métodos , Humanos , Estudos Longitudinais
10.
J Electrocardiol ; 73: 144-147, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-32838962

RESUMO

The spiked-helmet sign is a marker for high mortality in critical patients. It is characterised as a dome-shaped ST-segment elevation accompanied by an upward shift of the baseline before the onset of the QRS complex. We present two patients with the spiked-helmet sign on electrocardiogram. Patient A showed a potential relationship between the spiked-helmet sign and hyper-osmolar hyper-glycaemic state, whereas patient B had clinically suspected viral myocarditis.


Assuntos
Eletrocardiografia , Traumatismos Cardíacos , Arritmias Cardíacas , Biomarcadores , Dispositivos de Proteção da Cabeça , Humanos
11.
J Ment Health ; 31(3): 374-382, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34559976

RESUMO

BACKGROUND: Suicide remains the second leading cause of death among youths. Family-related factors are considered important determinants of children's suicidal ideation, whereas their short-/long-term influence is seldom quantified. AIMS: We aim to confirm the simultaneous/lagged effects of family-related factors on the occurrence of recent suicidal ideation from childhood to young adulthood (aged from 10 to 22 years old). METHOD: Data were derived from a longitudinal prospective cohort study. Participants included 2065 students who were followed up for 13 years. Generalized estimating equations were used to clarify the influential effects of family-related factors on suicidal ideation during the past month. RESULTS: The peak of the rate of recent suicidal ideation arrived during junior high school years. Family interaction, family support, family involvement, and parental punishment had simultaneous effects on recent suicidal ideation. Family involvement, parental conflict, and psychological control had lagged and lasting effects on suicidal ideation. Notably, the lasting protective effects of family involvement were more obvious than simultaneous effects. CONCLUSIONS: Providing parents with sustained support and education to improve their "positive parenting literacy" can help with their children's mental health development. This is especially the case during COVID-19 quarantine periods when families spend the most time together at home.


Assuntos
COVID-19 , Ideação Suicida , Adolescente , Adulto , Criança , Humanos , Pais , Estudos Prospectivos , Fatores de Risco , Adulto Jovem
12.
Hu Li Za Zhi ; 69(2): 7-12, 2022 Apr.
Artigo em Zh | MEDLINE | ID: mdl-35318627

RESUMO

The electronic whiteboard system is an important part of smart medical care. This system has been digitized and upgraded gradually over time, and now functions as a dashboard, incorporating sound effects, touch control, image display, face recognition, and other functions that maximize usage efficiency. In hospitals, electronic whiteboards are specialized for dedicated use in one of two areas: nursing stations and wards. Those used in nursing stations may upload data into the medical information system based on departmental and institutional requirements. Systems are built to the specific needs of different clinical departments and thus differ widely in terms of settings and functionality. Therefore, hospitals should promote regular communication among doctors, nurses, and patients.


Assuntos
Hospitais , Médicos , Comunicação , Eletrônica , Humanos , Taiwan
13.
J Bone Miner Metab ; 39(2): 174-185, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32757040

RESUMO

INTRODUCTION: Data is currently lacking regarding association between the cholecystectomy/hepatectomy/pancreatectomy and the development of osteoporotic fracture. A retrospective cohort study was conducted to investigate the relationship between cholecystectomy/hepatectomy/pancreatectomy and the subsequent risk of developing osteoporotic fracture. MATERIALS AND METHODS: Patients having undergone cholecystectomy, hepatectomy, or pancreatectomy between 2000 and 2012 were selected from the All Population Based Hospitalization File as the surgery cohort (n = 304,081), which was frequency matched with the control cohort (n = 304,081). The Cox proportional hazard model and Kaplan-Meier analysis were applied to measure the hazard ratios and the cumulative incidence of osteoporotic fracture. RESULTS: A total of 1136 patients in the surgery cohort and 1179 patients in the control cohort were newly diagnosed with osteoporotic fracture. The overall osteoporotic fracture risk in the surgery cohort was 1.12-fold higher [95% confidence interval (CI), 1.03-1.21]. Specifically, surgery cohort had higher vertebral fracture risk than non-surgery cohort [adjusted hazard ratio (aHR) 1.12, Cl, 1.03-1.22]. In addition, patients underwent cholecystectomy (includes open and laparoscopic approaches), hepatectomy (only open approach), and pancreatectomy group (only open approach) were 1.10 (95% CI, 1.01-1.19), 1.49 (95% CI, 1.10-2.01), and 1.88 (95% CI, 1.23-2.87) times more likely to develop osteoporotic fracture, respectively. No significant difference of osteoporotic fracture risk was observed between open and laparoscopic cholecystectomy. The risk of osteoporotic fracture was significantly increased in females, patients aged ≥ 40 years old, and patients with some comorbidity. CONCLUSIONS: Patients post cholecystectomy, hepatectomy, or pancreatectomy significantly increased risk of developing osteoporotic fracture, suggesting closer attention in post-operative care is needed.


Assuntos
Colecistectomia/efeitos adversos , Hepatectomia/efeitos adversos , Fraturas por Osteoporose/epidemiologia , Pancreatectomia/efeitos adversos , Fraturas da Coluna Vertebral/epidemiologia , Estudos de Coortes , Comorbidade , Feminino , Hospitalização , Humanos , Incidência , Estimativa de Kaplan-Meier , Laparoscopia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de Risco
14.
BMC Med Res Methodol ; 21(1): 219, 2021 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-34666680

RESUMO

BACKGROUND: With the dramatic increase in the pipeline for new sickle cell disease (SCD) therapies in recent years, the time is ripe to ensure a robust body of evidence is available for decision making by regulators, payers, clinicians, and patients. Harmonization of the outcomes selected across interventional trials enables optimal post-trial appraisal and decision making through valid pooled analyses and indirect comparisons. We employed a structured, multi-stakeholder consensus process to develop core outcome sets (COS) for use in clinical trials of SCD interventions. METHODS: CoreSCD utilized a modified Delphi method adapted from the standards recommended by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. An initial list of candidate outcomes was developed through a targeted literature review and input from an 11-member advisory committee. A 44-member multi-stakeholder Delphi Panel was established and included patients and family members, advocates, clinicians, researchers, payers, health technology assessors, representatives from government agencies, and industry representatives. Patients/advocates comprised 25% of the Delphi Panel and orientation and training was provided prior to the consensus process to ensure all were prepared to participate meaningfully. Panelists completed three rounds of an online survey to rate the importance of candidate outcomes for inclusion in the COS. Summary data was provided between each voting round and an in-person consensus meeting was held between the second and third round of voting. Consensus rules were applied following each round of voting to eliminate outcomes that did not meet predetermined criteria for retention. RESULTS: Consensus was reached for two core outcome sets. The final COS for trials of disease-modifying therapies includes ten outcomes and the COS for trials of acute interventions includes six outcomes. Both core sets include clinical outcomes as well as outcomes related to functioning/quality of life, resource utilization, and survival/mortality. CONCLUSIONS: Use of the COS in clinical development programs for SCD will help to ensure that relevant, consistent outcomes are available for decision making across the product lifecycle.


Assuntos
Anemia Falciforme , Qualidade de Vida , Anemia Falciforme/terapia , Consenso , Técnica Delphi , Humanos , Avaliação de Resultados em Cuidados de Saúde , Projetos de Pesquisa , Resultado do Tratamento
15.
Ann Allergy Asthma Immunol ; 127(1): 116-122.e7, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33781936

RESUMO

BACKGROUND: Treatments for long-term control of asthma have improved and include a promising but expensive class of biologic therapies. However, the clinical trials evaluating these and other novel treatments have used a variety of different outcomes to evaluate efficacy. The evolution of asthma care calls for a re-examination of outcomes that are most important to patients and other stakeholders. OBJECTIVE: To develop a core set of outcomes to be measured in phase 3 and phase 4 clinical drug trials in patients with moderate-to-severe asthma. METHODS: We used a robust and in-depth multistakeholder consensus process bringing together patients, clinicians, regulators, payers, health technology assessors, researchers, and product developers to reach consensus on outcomes. We used a modified Delphi method to reach consensus, an approach adapted from the Core Outcome Measures in Effectiveness Trials Initiative aligned with contemporary methodological standards for core outcome set development. RESULTS: The following outcomes were included in the final core set: severe asthma exacerbation, change in asthma control, asthma-specific or severe asthma-specific quality of life, asthma-specific hospital stay (ie, >24-hour stays at any level of care) or admission, and asthma-specific emergency department visit. CONCLUSION: These 5 outcomes represent a minimum set of core outcomes for use in phase 3 and phase 4 clinical drug trials in moderate-to-severe asthma. Consistent collection of these outcomes as minimum, independent of whether additional heterogeneous primary or secondary outcomes are included, will allow for meaningful comparisons of the effect of asthma therapies across clinical trials.


Assuntos
Asma/terapia , Determinação de Ponto Final/normas , Pulmão/fisiopatologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Asma/diagnóstico , Asma/mortalidade , Asma/fisiopatologia , Ensaios Clínicos como Assunto , Consenso , Técnica Delphi , Humanos , Pesquisa Qualitativa , Qualidade de Vida , Literatura de Revisão como Assunto , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Participação dos Interessados , Resultado do Tratamento
16.
J Asthma ; 58(7): 855-864, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-32192353

RESUMO

OBJECTIVES: Biologic therapies are emerging as an option to treat a subset of patients with severe asthma, however no direct comparison between these agents has been conducted. Furthermore, heterogeneity of outcomes in clinical trials makes it difficult to compare these agents and traditional therapies. The extent to which this heterogeneity exists has major implications for evidence-based decisions and is yet to be fully reported. We conducted a literature search to examine outcomes currently being used in clinical trials for asthma. DATA SOURCES: The Cochrane Library and Clinicaltrials.gov were searched for clinical trials of asthma interventions. STUDY SELECTIONS: We limited our search to phase 2 through 4 clinical trials in adults, as early-phase trials tend to have pharmacodynamic and pharmacokinetic endpoints as primary outcomes. Interventions for acute exacerbations were excluded. RESULTS: We identified 117 studies and subsequently identified 111 outcomes. The most prevalent outcomes were asthma control and symptom severity, FEV1, and change in ACQ scale. Twenty patient-reported outcomes instruments were identified and de-facto standard asthma outcomes and PROs were under-reported in examined literature. Existing quality of life tools did not capture the day-to-day experience or the unique treatment burden from oral corticosteroids for patient with severe asthma. Compounding the absence of trials directly comparing therapies, the significant variation we identified in outcome definitions and measurement create hurdles to effectively compare traditional and biologic therapies. CONCLUSION: With the growing number of clinical trials evaluating advanced therapies such as biologics, a wide range of primary and secondary outcomes are evaluated. A core outcome set created by relevant stakeholders is needed to collectively evaluate pooled outcomes in order to allow more meaningful comparisons of asthma therapies and to incorporate the patient experience.


Assuntos
Asma/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Qualidade de Vida , Projetos de Pesquisa , Testes de Função Respiratória , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Ensaios Clínicos Fase IV como Assunto , Determinação de Ponto Final , Humanos , Medidas de Resultados Relatados pelo Paciente , Índice de Gravidade de Doença , Resultado do Tratamento
17.
Eur Child Adolesc Psychiatry ; 30(4): 647-655, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32394091

RESUMO

The objective of this study is to assess the prevalence and risk factors for attention-deficit hyperactivity disorder (ADHD) in a large cohort of patients with congenital heart disease (CHD). Patients (n = 695) with CHD who were aged 6-15 years and visited the outpatient clinics in our hospital from June 2015 to May 2017 were enrolled. Their medical records were collected, and the Chinese version of the Swanson, Nolan, and Pelham rating scale (SNAP-IVc) and a questionnaire about neuropsychiatric care-seeking behavior were completed by parents and counselors. Of the 695 patients, the overall prevalence of ADHD was 12.4%, including 3.2% for the combined subtype, 6.8% for the inattentive-predominant subtype, and 2.4% for the hyperactivity/impulsive-predominant subtype. Only the inattention-predominant subtype was significantly more prevalent than in the general population. The prevalence of the inattention-predominant subtype was highest in the patients with cyanotic CHD, high severity index, and in those who had received surgery or cardiopulmonary bypass. Multivariate regression analysis indicated that the risk factors for inattention-related symptoms included postoperative seizure and previous cardiopulmonary bypass (odds ratio: 3.22 and 3.82; P = 0.027 and < 0.001, respectively). Only 58.7% of the patients with probable ADHD ever sought neuropsychiatric care, and only 27% regularly attended neuropsychiatric clinics. The inattention-predominant subtype of ADHD was more prevalent in our CHD patients, especially in those with cyanotic CHD, higher disease severity index, and in those who had undergone a surgical intervention. The percentage of patients receiving regular neuropsychiatric clinic follow-up was low.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/genética , Cardiopatias Congênitas/complicações , Comportamento Impulsivo/fisiologia , Adolescente , Criança , Estudos de Coortes , Feminino , Humanos , Masculino , Prevalência , Fatores de Risco , Inquéritos e Questionários
18.
J Cardiovasc Nurs ; 36(3): 293-303, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33538530

RESUMO

BACKGROUND: Cyanotic congenital heart disease (CHD) has detrimental effects on behavioral function in children and adolescents. However, few study authors have examined the underlying mechanisms of these effects. OBJECTIVE: The aims of this study were to investigate the mediating effects of parenting stress in the association between cyanotic CHD and externalizing problems and to explore whether age moderated these mediating effects. METHODS: A total of 697 children and adolescents (aged 2-17 years) with CHD (252 with cyanotic CHD and 445 with acyanotic CHD) in Taiwan were enrolled. The Child Behavior Checklist and the Parenting Stress Index were used to assess externalizing problems and parenting stress, respectively. Mediation analysis was performed to determine the mediating effects of parenting stress in the association between cyanotic CHD and externalizing problems. A moderated mediation model was used to investigate the moderating effect of age on the observed mediating effects. RESULTS: Parenting stress significantly mediated the relationship between cyanotic CHD and externalizing problems (unstandardized coefficient B = 0.98; 95% bootstrap confidence interval, 0.23-1.78). Children's age further moderated the mediating effects, with greater effects in older children. Age also moderated the association between cyanotic CHD and parenting stress, such that the effects were only significant in children older than 5.7 years. CONCLUSIONS: Our study revealed that age affected the mediating effects of parenting stress in the relationship between cyanotic CHD and externalizing problems. Efforts to reduce externalizing problems in children and adolescents with cyanotic CHD by targeting parenting stress may be more effective when age differences are considered.


Assuntos
Cardiopatias Congênitas , Poder Familiar , Adolescente , Criança , Pré-Escolar , Cianose/etiologia , Cardiopatias Congênitas/complicações , Humanos , Taiwan/epidemiologia
19.
Sensors (Basel) ; 21(4)2021 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-33562712

RESUMO

Water is one of the most precious resources. However, industrial development has made water pollution a critical problem today and thus water quality monitoring and surface cleaning are essential for water resource protection. In this study, we have used the sensor fusion technology as a basis to develop a multi-function unmanned surface vehicle (MF-USV) for obstacle avoidance, water-quality monitoring, and water surface cleaning. The MF-USV comprises a USV control unit, a locomotion module, a positioning module, an obstacle avoidance module, a water quality monitoring system, a water surface cleaning system, a communication module, a power module, and a remote human-machine interface. We equip the MF-USV with the following functions: (1) autonomous obstacle detection, avoidance, and navigation positioning, (2) water quality monitoring, sampling, and positioning, (3) water surface detection and cleaning, and (4) remote navigation control and real-time information display. The experimental results verified that when the floating garbage located in the visual angle ranged from -30° to 30° on the front of the MF-USV and the distances between the floating garbage and the MF-USV were 40 and 70 cm, the success rates of floating garbage detection are all 100%. When the distance between the floating garbage and the MF-USV was 130 cm and the floating garbage was located on the left side (15°~30°), left front side (0°~15°), front side (0°), right front side (0°~15°), and the right side (15°~30°), the success rates of the floating garbage collection were 70%, 92%, 95%, 95%, and 75%, respectively. Finally, the experimental results also verified that the applications of the MF-USV and relevant algorithms to obstacle avoidance, water quality monitoring, and water surface cleaning were effective.

20.
J Environ Manage ; 298: 113533, 2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-34411797

RESUMO

Among the many causes of habitat loss, urbanization coupled with climate change has produced some of the greatest local extinction rates and has led to the loss of many native species. Managing native vegetation in a rapidly expanding urban setting requires land management strategies that are cognizant of these impacts and how species and communities may adapt to a future climate. Here, we demonstrate how identifying climate refugia for threatened vegetation communities in an urban matrix can be used to support management decisions by local government authorities under the dual pressures of urban expansion and climate change. This research was focused on a local government area in New South Wales, Australia, that is undergoing significant residential, commercial and agricultural expansion resulting in the transition of native forest to other more intensive land-uses. Our results indicate that the key drivers of change from native vegetation to urban and agriculture classes were population density and the proximity to urban areas. We found two of the most cleared vegetation community types are physically restricted to land owned or managed by council, suggesting their long-term ecological viability is uncertain under a warming climate. We propose that land use planning decisions must recognize the compounding spatial and temporal pressures of urban development, land clearing and climate change, and how current policy responses, such as biodiversity offsetting, can respond positively to habitat shifts in order to secure the longevity of important ecological communities.


Assuntos
Mudança Climática , Conservação dos Recursos Naturais , Biodiversidade , Ecossistema , Florestas
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