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Family functioning plays an important role in explaining the high prevalence of depressive symptoms in adolescents and it is necessary to identify the family functioning characteristics responsible for this relationship. In turn, while socioeconomic status (SES) is associated with adolescent depressive symptoms, the mechanisms that explain this relationship are largely unknown. In this study, we used the McMaster Family Assessment Device (FAD) to obtain a picture of the family functioning dimensions that genuinely contribute to explaining the relationship between family functioning and adolescent depressive symptoms and analyzed the mediating effect of family functioning on the impact of SES on depressive symptoms. Regression-based conditional process analysis was used with a sample of 636 adolescents aged 12-17 years. Pratt's measures in regression analyses showed that 95% of the variance in depressive symptoms was accounted for by three of the six FAD dimensions: the ability to experience and express emotions appropriately-Affective Responsiveness-the ability to maintain adequate involvement among family members-Affective Involvement-and the ability to set and abide by rules and standards of behavior-Behavioral Control. Results also showed that the impact of SES on depressive symptoms was mediated by the existence of clear expectations about standards of behavior and behavioral patterns for handling family tasks-Behavioral Control and Roles-and, for the boys, by experiencing and expressing emotions appropriately. The results emphasize the importance of affect and clear-cut family rules to prevent adolescent depressive symptoms and suggest that the existence of family rules and roles buffer the impact of SES on adolescent wellbeing.
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Depressão , Família , Masculino , Humanos , Adolescente , Depressão/psicologia , Família/psicologia , Emoções , Características da Família , Classe SocialRESUMO
PURPOSE: To estimate the cost-effectiveness of adding a CDK4/6 inhibitor to standard endocrine therapy in the first-line setting for advanced HR+/HER2- breast cancer in postmenopausal and premenopausal women, from the perspective of the Mexican public healthcare system. METHODS: We used a partitioned survival model to simulate relevant health outcomes in a synthetic cohort of patients with breast cancer derived from the PALOMA-2, MONALEESA-2, MONARCH-3 trials for postmenopausal patients, and from the MONALEESA-7 study for premenopausal patients. Effectiveness was measured in life years gained. Cost-effectiveness is reported through incremental cost-effectiveness ratios (ICER). RESULTS: In postmenopausal patients, palbociclib led to an increase of 1.51 life years, ribociclib of 1.58 years, and abemaciclib of 1.75 years, compared to letrozole alone. The ICER was 36,648 USD, 32,422 USD, and 26,888 USD, respectively. In premenopausal patients, ribociclib led to an increase of 1.82 life years when added to goserelin and endocrine therapy, with an ICER of 44,579 USD. In the cost minimization analysis, for postmenopausal patients, ribociclib was the treatment with the highest costs due to follow-up requirements. CONCLUSION: Palbociclib, ribociclib, and abemaciclib demonstrated a significant increase in effectiveness in postmenopausal patients, and ribociclib in premenopausal patients, when added to standard endocrine therapy for patients with advanced HR+/HER2- breast cancer. At the national stablished willingness to pay, only the addition of abemaciclib to standard endocrine therapy in postmenopausal women would be considered cost-effective. However, differences on results between therapies for postmenopausal patients were not statistically significant.
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Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Análise Custo-Benefício , México , Aminopiridinas/uso terapêutico , Proteínas Inibidoras de Quinase Dependente de Ciclina/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica , Receptor ErbB-2 , Quinase 4 Dependente de CiclinaRESUMO
BACKGROUND: Autoantibodies are critical elements in RA pathogenesis and clinical assessment. The anti-malondialdehyde-acetaldehyde (anti-MAA) antibodies are potentially useful because of their claimed high sensitivity for all RA patients, including those lacking RF and anti-CCP antibodies. Therefore, we aimed to replicate these findings. METHODS: We independently attempted replication in Santiago and Barcelona using sera from 517 and 178 RA patients and 272 and 120 healthy controls, respectively. ELISA protocols for anti-MAA antibodies included five antigens (human serum albumin in three formulations, fibrinogen, and a synthetic peptide) and assays for the IgG, IgM, and IgA isotypes. We integrated our results with information found by searching the Web of Science for reports of anti-MAA antibodies in RA. The available patients (4989 in 11 sets) were included in a meta-analysis aimed at heterogeneity between studies. Factors accounting for heterogeneity were assessed with meta-regression. RESULTS: The sensitivity of anti-MAA antibodies in our RA patients was low, even in seropositive patients, with the percentage of positives below 23% for all ELISA conditions. Our results and bibliographic research showed IgG anti-MAA positive patients ranging from 6 to 92%. The extreme between-studies heterogeneity could be explained (up to 43%) in univariate analysis by sex, African ethnicity, the site of study, or recruitment from the military. The best model, including African ancestry and smoking, explained a high heterogeneity fraction (74%). CONCLUSION: Anti-MAA antibody sensitivity is extremely variable between RA patient collections. A substantial fraction of this variability cannot be attributed to ELISA protocols. On the contrary, heterogeneity is determined by complex factors that include African ethnicity, smoking, and sex.
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Acetaldeído , Artrite Reumatoide , Humanos , Malondialdeído , Autoanticorpos , Imunoglobulina G , Fator Reumatoide , Peptídeos CíclicosRESUMO
This study sought to evaluate the psychometric properties of a Spanish version of the PEG scale (PEG-S, whose items assess Pain intensity and pain interference with Enjoyment of life and General activity) in a sample of Spanish-speaking adults receiving care for pain at primary care clinics in the Northwestern United States. We evaluated the PEG-S's 1) internal consistency, 2) convergent validity, and 3) discriminant validity. All participants (n = 200, mean age = 52 years [SD = 15], 76% women, mean PEG-S score = 5.7 [SD = 2.5]) identified as having Hispanic or Latino ethnicity, and detailed ethnic origin was predominantly Mexican or Chicano (70%). The PEG-S's internal consistency (Cronbach's alpha, .82) was good. Correlations between the PEG-S scale scores and established measures of pain intensity and interference ranged from .68 to .79, supporting the measure's convergent validity. The correlation between the PEG-S scale score and the Patient Health Questionnaire-9 (r = .53) was weaker than those between the PEG-S scale and measures of pain intensity and interference, supporting the measure's discriminant validity. The findings support reliability and validity of the PEG-S for assessing a composite score of pain intensity and interference among Spanish-speaking adults. PERSPECTIVE: We present evidence supporting the reliability and validity of the PEG scale in Spanish (PEG-S) in a sample of adults receiving pain care at primary care clinics in the Northwestern United States. This 3-item composite measure of pain intensity and interference can help clinicians and researchers assess pain among Spanish-speaking adults.
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Hispânico ou Latino , Medição da Dor , Dor , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor/diagnóstico , Atenção Primária à Saúde , Psicometria , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Cardiac computed tomography angiography (CCTA) is precise in noninvasive coronary atherosclerosis characterization but its value in the diagnosis of intracoronary thrombus remains unknown. Therefore, our aim was to evaluate CCTA for intracoronary thrombus and stenosis detection in patients with acute coronary syndromes with high thrombus burden selected for a deferred stenting strategy. METHODS: We systematically performed a CCTA in consecutive patients following a deferred stenting strategy, 24 h before the scheduled repeated coronary angiography including optical coherence tomography (OCT) imaging. Intracoronary thrombus and residual stenosis were blindly and independently evaluated by both techniques. Agreement was determined per lesion using the weighted Kappa ( K ) coefficient and absolute intraclass correlation coefficient (ICC). A stratified analysis according to OCT-detected thrombus burden was also performed. RESULTS: Thirty lesions in 28 consecutive patients were analyzed. Concordance between CCTA and repeated coronary angiography in thrombus detection was good ( K = 0.554; P < 0.001), but both showed poor agreement with OCT. CCTA needed >11.5% thrombus burden on OCT to obtain adequate diagnostic accuracy. The lesions detected by angiography were more frequently classified as red thrombus (76.5 vs. 33.3%; P = 0.087) on OCT. CCTA showed an excellent concordance with coronary angiography in diameter measurement (ICC = 0.85; P < 0.001) and was able to identify all the patients with severe residual stenosis. CONCLUSIONS: Although CCTA showed just a good concordance with angiography in intracoronary thrombus detection, the agreement in residual stenosis was excellent. Thus, in patients with a high-thrombus burden selected for a deferred stenting strategy CCTA may substitute repeat angiography.
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Doença da Artéria Coronariana , Estenose Coronária , Trombose Coronária , Humanos , Angiografia por Tomografia Computadorizada , Estudos Prospectivos , Constrição Patológica , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Angiografia Coronária/métodos , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/terapia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Valor Preditivo dos TestesRESUMO
A low-cost smart sensor GNSS system has been developed to provide accurate real-time position and orientation measurements on a floating offshore wind platform. The approach chosen to offer a viable and reliable solution for this application is based on the use of the well-known advantages of the GNSS system as the main driver for enhancing the accuracy of positioning. For this purpose, the data reported in this work are captured through a GNSS receiver operating over multiple frequency bands (L1, L2, L5) and combining signals from different constellations of navigation satellites (GPS, Galileo, and GLONASS), and they are processed through the precise point positioning (PPP) and real-time kinematic (RTK) techniques. Furthermore, aiming to improve global positioning, the processing unit fuses the results obtained with the data acquired through an inertial measurement unit (IMU), reaching final accuracy of a few centimeters. To validate the system designed and developed in this proposal, three different sets of tests were carried out in a (i) rotary table at the laboratory, (ii) GNSS simulator, and (iii) real conditions in an oceanic buoy at sea. The real-time positioning solution was compared to solutions obtained by post-processing techniques in these three scenarios and similar results were satisfactorily achieved.
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Vento , Decoração de Interiores e Mobiliário , LaboratóriosRESUMO
Introduction: In rural India the scarcity of physiotherapists and inequalities complicate the recovery of traumatized children. This study protocol will explore a digital physiotherapy intervention in children with ankle fracture in a low-resource setting to improve functional independence and quality of life. Methods and analysis: A randomized clinical trial with a mixed quantitative-qualitative design will be carried out. It is a single-blind study, where the evaluator does not know the nature of the intervention. Sixty subjects will be enrolled and randomly divided into two groups: the experimental group (EG) will receive a 4-week digital physiotherapy intervention through an app in a recycled mobile device after hospital discharge; the control group (CG) will receive the physiotherapy standard care recommended for patients discharged from the hospital. Subjects will receive a baseline (T0-pre) assessment of Functional Independence and Quality of Life. At the end of the 4-week intervention (T1-post) a new assessment of the outcome will be performed adding data on adherence, satisfaction (ad hoc questionnaire and TSQ), and barriers of use. Qualitative outcomes will also be explored. The author's hypothesized that the implementation of a digital physiotherapy intervention is feasible and effective to improve functional independence and quality of life. This study protocol is the first to explore the effect of digital physiotherapy intervention in children's patients in a low resource setting (Anantapur). Discussion: The successful delivery of the intervention, an optimal adherence records, the absence of significant adverse effects, user satisfaction level and the qualitative analysis of limitations, will demonstrate the effectiveness of these procedure. This study will add more evidence in support the use of digital physiotherapy practice as an effective tool. User particularities, provider's capacity, technological and cultural limitations, and considerations for vulnerable populations will be taken into account. Clinical trial registration: NCT04946695 (https://clinicaltrials.gov/).
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Modalidades de Fisioterapia , Qualidade de Vida , Criança , Humanos , Índia , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Inquéritos e QuestionáriosRESUMO
Internet of Things (IoT) landscape to cover long-range applications. The LoRa-enabled IoT devices adopt an Adaptive Data Rate-based (ADR) mechanism to assign transmission parameters such as spreading factors, transmission energy, and coding rates. Nevertheless, the energy assessment of these combinations should be considered carefully to select an accurate combination. Accordingly, the computational and transmission energy consumption trade-off should be assessed to guarantee the effectiveness of the physical parameter tuning. This paper provides comprehensive details of LoRa transceiver functioning mechanisms and provides a mathematical model for energy consumption estimation of the end devices EDs. Indeed, in order to select the optimal transmission parameters. We have modeled the LoRa energy optimization and transmission parameter selection problem as a Markov Decision Process (MDP). The dynamic system surveys the environment stats (the residual energy and channel state) and searches for the optimal actions to minimize the long-term average cost at each time slot. The proposed method has been evaluated under different scenarios and then compared to LoRaWAN default ADR in terms of energy efficiency and reliability. The numerical results have shown that our method outperforms the LoRa standard ADR mechanism since it permits the EDs to gain more energy. Besides, it enables the EDs to stand more, consequently performing more transmissions.
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Internet das Coisas , Bases de Dados Factuais , Cadeias de Markov , Modelos Teóricos , Reprodutibilidade dos TestesRESUMO
The development of sensing devices for precision agriculture is crucial to boost crop yields and limit shortages in food productions due to the growing population. However, current approaches cannot provide direct information about the physiological status of the plants, reducing sensing accuracy. The development of implanted devices for plant monitoring represents a step forward in this field, enabling the direct assessment of key biomarkers in plants. However, available devices are expensive and cannot be used for long-term applications. The current work presents the application of ruthenium oxide-based nanofilms for the in vivo monitoring of pH in plants. The sensors were manufactured using the low-cost electrodeposition of RuO2 films, and the final device could be successfully incorporated for the monitoring of xylem sap pH for at least 10 h. RuO2 nanoparticles were chosen as the sensing material due to its biocompatibility and chemical stability. To reduce the noise rates and drift of the sensors, a protective layer consisting of a cellulose/PDMS hybrid material was deposited by an aerosol method (>GBP 50), involving off-the-shelf devices, leading to a good control of film thickness. Nanometrically thin films with a thickness of 80 nm and roughness below 3 nm were fabricated. This film led to a seven-fold decrease in drift while preserving the selectivity of the sensors towards H+ ions. The sensing devices were tested in vivo by implantation inside a tomato plant. Environmental parameters such as humidity and temperature were additionally monitored using a low-cost Wio Terminal device, and the data were sent wirelessly to an online server. The interactions between plant tissues and metal oxide-based sensors were finally studied, evidencing the formation of a lignified layer between the sensing film and xylem. Thus, this work reports for the first time a low-cost electrochemical sensor that can be used for the continuous monitoring of pH in xylem sap. This device can be easily modified to improve the long-term performance when implanted inside plant tissues, representing a step forward in the development of precision agriculture technologies.
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Solanum lycopersicum , Agricultura , Concentração de Íons de Hidrogênio , Monitorização Fisiológica , ÓxidosRESUMO
Spontaneity and its connections to mental health and wellbeing are a central issue in both theory and practice of psychodrama, and the specialized literature sometimes even associates the presence of pathology to a lack of spontaneity. This paper describes spontaneity in Moreno's theory, its assessment, its association with other measures and concepts, and scientific advances in the field. Specifically, we present results obtained with the English and Portuguese-language versions concerning its assessment. The main purpose of this work was to study the spontaneity measure (SAI-R) in a 3 first-order factors version for a Portuguese sample of 439 subjects, divided into two independent samples. The mean age of participants was 25.6 years (SD = 10.2), and ages ranged between 18 and 64 years. Data was collected through an online platform of a Portuguese market research company. The results revealed that the 3-factor model has acceptable validity for items 1 ("Creative") and 7 ("Euphoric"), confirming the composite reliability, the convergent validity, but not the discriminant validity. Through multi-group analysis, the model proved to be stable. Notwithstanding the need for complementary studies, including clinical samples, the SAI-R is a short and valid instrument in clinical and non-clinical contexts when evaluating spontaneity.
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Idioma , Psicodrama , Adolescente , Adulto , Humanos , Pessoa de Meia-Idade , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários , Adulto JovemRESUMO
Objective.Using Monte-Carlo simulations, we evaluated the physical performance of a hypothetical state-of-the-art clinical PET scanner with adaptive axial field-of-view (AFOV) based on the validated GATE model of the Siemens Biograph VisionTMPET/CT scanner.Approach.Vision consists of 16 compact PET rings, each consisting of 152 mini-blocks of 5 × 5 Lutetium Oxyorthosilicate crystals (3.2 × 3.2 × 20 mm3). The Vision 25.6 cm AFOV was extended by adopting (i) a sparse mini-block ring (SBR) configuration of 49.6 cm AFOV, with all mini-block rings interleaved with 16 mm axial gaps, or (ii) a sparse mini-block checkerboard (SCB) configuration of 51.2 cm AFOV, with all mini-blocks interleaved with gaps of 16 mm (transaxial) × 16 mm (axial) width in checkerboard pattern. For sparse configurations, a 'limited' continuous bed motion (limited-CBM) acquisition was employed to extend AFOVs by 2.9 cm. Spatial resolution, sensitivity, image quality (IQ), NECR and scatter fraction were assessed per NEMA NU2-2012.Main Results.All IQ phantom spheres were distinguishable with all configurations. SBR and SCB percent contrast recovery (% CR) and background variability (% BV) were similar (p-value > 0.05). Compared to Vision, SBR and SCB %CRs were similar (p-values > 0.05). However, SBR and SCB %BVs were deteriorated by 30% and 26% respectively (p-values < 0.05). SBR, SCB and Vision exhibited system sensitivities of 16.6, 16.8, and 15.8 kcps MBq-1, NECRs of 311 kcps @35 kBq cc-1, 266 kcps @25.8 kBq cc-1, and 260 kcps @27.8 kBq cc-1, and scatter fractions of 31.2%, 32.4%, and 32.6%, respectively. SBR and SCB exhibited a smoother sensitivity reduction and noise enhancement rate from AFOV center to its edges. SBR and SCB attained comparable spatial resolution in all directions (p-value > 0.05), yet, up to 1.5 mm worse than Vision (p-values < 0.05).Significance.The proposed sparse configurations may offer a clinically adoptable solution for cost-effective adaptive AFOV PET with either highly-sensitive or long-AFOV acquisitions.
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Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Tomografia por Emissão de Pósitrons , Método de Monte Carlo , Imagens de Fantasmas , Desempenho Físico Funcional , Tomografia por Emissão de Pósitrons/métodosRESUMO
PURPOSE: To evaluate the cost-effectiveness of a strategy based on direct-acting uterine curettage (UC) versus a pre-direct-acting misoprostol (1600 mg) in patients with missed abortion (MA), from the perspective of a National Health System. METHODS: An open prospective cohort study was carried out at Reina Sofía University Hospital (Córdoba, Spain) from January 1, 2019 to December 31, 2019 in 180 patients diagnosed with MA. The patients chose medical treatment with intravaginal misoprostol (800 µg/4 h) or UC after receiving complete and detailed information. The effectiveness, clinical characteristics of the patients, costs of treating and managing the disease, and satisfaction with the procedures were recorded. RESULTS: One hundred and forty-five patients (80.6%) chose misoprostol versus 35 patients (19.4%) who chose UC. The effectiveness of misoprostol has been 42% evaluated at 48 h; UC success rate has been 100%. The incidence of side effects is significantly higher in patients treated with misoprostol (p < 0.05); as well as the number of care received by the patient (p < 0.05). Satisfaction is higher in patients treated with UC (p < 0.05). However, the cost is almost 5-folds higher in patients treated with UC (p < 0.05). CONCLUSION: UC has a higher success rate, greater satisfaction, and a lower incidence of side effects, although significantly increases the cost compared to misoprostol in MA.
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Abortivos não Esteroides , Aborto Induzido , Aborto Retido , Misoprostol , Abortivos não Esteroides/uso terapêutico , Aborto Retido/tratamento farmacológico , Aborto Retido/cirurgia , Administração Intravaginal , Análise Custo-Benefício , Curetagem , Feminino , Humanos , Misoprostol/uso terapêutico , Gravidez , Estudos ProspectivosRESUMO
Currently news and/or articles on the use of Artificial Intelligence and the Big Data are flooding us and this situation has worsened with the pandemic, where great importance has been given to its use and the various applications in all sectors. Some areas of technology and opportunities that are increasingly are more present in our day to day. The sector that has experienced the most growth during this time of pandemic is, without a doubt, the Health sector. The imperative need has fostered and expedited the use of these technologies. The use of data to be able to undertake treatments in a short time, see the evolutions of the different diseases and predict their state is what has driven its use and where due to the situation any help was and is little. From this article we intend to give an explanation of the benefits of using the Artificial Intelligence and the different Big Data techniques, both in the study and evolution of diseases as in their prevention, detection, monitoring and treatment.
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Inteligência Artificial , Big Data , PandemiasRESUMO
OBJECTIVE: Our objective was to investigate whether women, people 65 yrs and older, or individuals who identify with racial and/or ethnic minority groups, were underrepresented among participants in rehabilitation clinical trials. DESIGN: This is a cross-sectional study of completed rehabilitation clinical trials investigating the number and percentage of women, older adults, and racial and/or ethnic minorities enrolled in rehabilitation clinical trials between January 1, 2011, and January 1, 2020. Secondary outcome measures were inclusion by diagnostic group, as well as International Classification of Functioning, Disability and Health category, and intervention by diagnostic group. RESULTS: Of the 108 studies meeting inclusion criteria, a majority (69%) were based in the United States. Stroke was the most frequent diagnostic group, followed by musculoskeletal conditions. Ninety-six percent of the United States-based trials included at least one female participant in their study, but among specific diagnostic groups, this ranged from 5% to 73%. Age information was reported inconsistently; however, of the trials reporting age, 100% of cardiac trials included older adults, whereas no spinal cord injury (SCI) trials included them. Among trials based in the United States reporting race, 70% of participants were White, followed by 20% Black or African American and 1% Asian. Among trials based in the United States reporting ethnicity, Hispanic or Latino participants were underrepresented overall and among each diagnostic group. CONCLUSIONS: In this study, we found that among participants of rehabilitation clinical trials women, older individuals, and racial/ethnic minorities were generally underrepresented. In contrast, Black or African American participants were overrepresented with the exception of cardiac trials. An important finding was that many trials did not report age and/or race/ethnicity. Investigators should aim to include underrepresented populations and improve reporting.
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Etnicidade , Grupos Minoritários , Seleção de Pacientes , Grupos Raciais , Reabilitação , Projetos de Pesquisa , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos como Assunto , Estudos Transversais , Feminino , Humanos , Fatores SexuaisRESUMO
Importance: Medical research has not equitably included members of racial/ethnic minority groups or female and older individuals. There are limited data on participant demographic characteristics in vaccine trials despite the importance of these data to current trials aimed at preventing coronavirus disease 2019. Objective: To investigate whether racial/ethnic minority groups and female and older adults are underrepresented among participants in vaccine clinical trials. Design, Setting, and Participants: This cross-sectional study examined data from completed US-based vaccine trials registered on ClinicalTrials.gov from July 1, 2011, through June 30, 2020. The terms vaccine, vaccination, immunization, and inoculation were used to identify trials. Only those addressing vaccine immunogenicity or efficacy of preventative vaccines were included. Main Outcomes and Measures: The numbers and percentages of racial/ethnic minority, female, and older individuals compared with US census data from 2011 and 2018. Secondary outcome measures were inclusion by trial phase and year of completion. Results: A total of 230 US-based trials with 219â¯555 participants were included in the study. Most trials were randomized (180 [78.3%]), included viral vaccinations (159 [69.1%]), and represented all trial phases. Every trial reported age and sex; 134 (58.3%) reported race and 79 (34.3%) reported ethnicity. Overall, among adult study participants, White individuals were overrepresented (77.9%; 95% CI, 77.4%-78.4%), and Black or African American individuals (10.6%; 95% CI, 10.2%-11.0%) and American Indian or Alaska Native individuals (0.4%; 95% CI, 0.3%-0.5%) were underrepresented compared with US census data; enrollment of Asian individuals was similar (5.7%; 95% CI, 5.5%-6.0%). Enrollment of Hispanic or Latino individuals (11.6%; 95% CI, 11.1%-12.0%) was also low even among the limited number of adult trials reporting ethnicity. Adult trials were composed of more female participants (75â¯325 [56.0%]), but among those reporting age as a percentage, enrollment of participants who were aged 65 years or older was low (12.1%; 95% CI, 12.0%-12.3%). Black or African American participants (10.1%; 95% CI, 9.7%-10.6%) and Hispanic or Latino participants (22.5%; 95% CI, 21.6%-23.4%) were also underrepresented in pediatric trials. Among trials reporting race/ethnicity, 65 (48.5%) did not include American Indian or Alaska Native participants and 81 (60.4%) did not include Hawaiian or Pacific Islander participants. Conclusions and Relevance: This cross-sectional study found that among US-based vaccine clinical trials, members of racial/ethnic minority groups and older adults were underrepresented, whereas female adults were overrepresented. These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections.
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Ensaios Clínicos como Assunto/normas , Etnicidade/estatística & dados numéricos , Seleção de Pacientes , Sexismo/estatística & dados numéricos , Vacinas , Adulto , Idoso , Idoso de 80 Anos ou mais , Povo Asiático/etnologia , Povo Asiático/estatística & dados numéricos , População Negra/etnologia , População Negra/estatística & dados numéricos , Ensaios Clínicos como Assunto/estatística & dados numéricos , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Havaiano Nativo ou Outro Ilhéu do Pacífico/etnologia , Havaiano Nativo ou Outro Ilhéu do Pacífico/estatística & dados numéricos , Grupos Raciais/etnologia , Grupos Raciais/estatística & dados numéricos , Sexismo/etnologia , População Branca/etnologia , População Branca/estatística & dados numéricosRESUMO
PURPOSE: The impact of disease activity or treatments on health-related quality of life (HRQL) is crucial in Oncology, but adequate instruments for this assessment are scarce. Our aim is to validate the Mexican-Spanish version of the QLQ-EN24 questionnaire to evaluate HRQL in women with endometrial cancer (EC). METHODS: This is a prospective study of Mexican women with EC, attending a single cancer centre, who responded the QLQ-C30 and QLQ-EN24 instruments; usual psychometric analysis were performed as well as the association of HRQL scales and relevant clinical data. Correlation analysis was performed with the Spearman's method, reliability analysis with the Cronbach's alpha, known-group comparisons with the Kruskal-Wallis test, and survival analysis with the Kaplan-Meier method and Log-rank test. RESULTS: One hundred and eighty-nine women with EC were assessed. Most functional scales reported high values, and most symptom scales, low. Questionnaire compliance rates were high and internal consistency tests demonstrated adequate convergent and divergent validity. Cronbach's α coefficients of the five multi-item scales the QLQ-EN24 instruments were from 0.659 to 0.887. Scales of the QLQ-C30 and QLQ-EN24 instruments distinguished among clinically distinct groups of patients, particularly based on serum albumin levels. The Urological symptoms, Gastrointestinal symptoms, Body image, Pelvic pain and Taste change scales were significantly associated with OS. CONCLUSION: The Mexican-Spanish version of the QLQ-EN24 questionnaire is reliable and valid for the assessment of HRQL in patients with EC and can be broadly used in multi-national clinical trials. However, conclusions derived from scales evaluating sexual function should be handled carefully.
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Neoplasias do Endométrio/psicologia , Qualidade de Vida , Inquéritos e Questionários/normas , Neoplasias do Endométrio/diagnóstico , Feminino , Humanos , Idioma , México , Estudos Prospectivos , Psicometria , Reprodutibilidade dos TestesAssuntos
Doença Cardíaca Carcinoide/diagnóstico por imagem , Técnicas de Imagem Cardíaca , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/diagnóstico por imagem , Idoso , Doença Cardíaca Carcinoide/fisiopatologia , Doença Cardíaca Carcinoide/cirurgia , Ecocardiografia Doppler em Cores , Feminino , Implante de Prótese de Valva Cardíaca , Hemodinâmica , Humanos , Imageamento por Ressonância Magnética , Imagem Multimodal , Valor Preditivo dos Testes , Valva Pulmonar/fisiopatologia , Valva Pulmonar/cirurgia , Insuficiência da Valva Pulmonar/fisiopatologia , Insuficiência da Valva Pulmonar/cirurgia , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
A espontaneidade e as suas ligações à saúde mental e ao bem-estar são uma componente central quer na teoria quer na prática do psicodrama, e a literatura especializada associa a presença de patologia à falta de espontaneidade. Neste artigo, elencam-se alguns dos resultados obtidos em estudos em língua inglesa do SAI-R e apresentam-se os estudos da sua validação para a população portuguesa. Na validação do SAI-R para o contexto português, foi confirmada a estrutura fatorial com 719 sujeitos, distribuídos em duas amostras independentes. Os participantes tinham idades entre os 18 e os 69 anos. Por fim, foram testadas a fiabilidade compósita e a validade convergente, bem como a validade do tipo critério em duas amostras independentes (n 1ªamostra =348 e n 2ªamostra =371). Apesar de serem necessários mais estudos com populações clínicas, o SAI-R apresenta-se como um instrumento curto e válido para aplicar em contextos clínicos e não clínicos quando se pretende avaliar a espontaneidade (AU).
Spontaneity and its connections to mental health and wellbeing are a central theme in both the theory and practice of psychodrama, and the specialized literature sometimes even associates the presence of pathology with a lack of spontaneity. In this article, we list some of the results obtained in studies with the English-language version of the spontaneity scale and present its validation studies for the Portuguese population. We verified a factorial structure with 719 subjects, divided into two independent samples in the validation of the SAI-R for the Portuguese context. Participants had an age range of 18 to 69 years old. Furthermore, composite reliability, convergent validity, and cross validity were tested in two other independent samples (n sample1 =348 and n sample2 =371). Although further studies with clinical samples are needed, the SAI-R presents itself as a short and valid instrument to apply in clinical and non-clinical settings when assessing spontaneity (AU).
La espontaneidad y sus vínculos con la salud mental y el bienestar son una componente central tanto en la teoría como en la práctica del psicodrama, y la literatura especializada asocia la presencia de patología con la falta de espontaneidad. En este artículo se enumeran resultados obtenidos con la versión inglesa del SAI-R y se presentan estudios para su aplicación en la población portuguesa. En la validación del SAI-R para el contexto portugués, se confirmó la estructura factorial con 719 sujetos, distribuidos en dos muestras independientes. Los participantes tenían entre 18 y 69 años. Finalmente, se probaron la confiabilidad compuesta y la validez convergente, así como la validez cruzada en las dos muestras independientes (n muestra 1 = 348 y n muestra2 = 371). Aunque son necesarios más estudios con poblaciones clínicas, el SAI-R se presenta como un instrumento breve y válido para ser aplicado en contextos clínicos y no clínicos en la evaluación de la espontaneidad (AU).
Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Psicodrama , Portugal , Inquéritos e Questionários , Reprodutibilidade dos Testes , Análise FatorialRESUMO
BACKGROUND: Health-related quality of life (HRQL) is an important outcome measure in Oncology. AIM OF THE STUDY: To validate the Mexican-Spanish version of the QLQ-OV28 questionnaire to assess HRQL in women with ovarian cancer (OC). METHODS: The QLQ-C30 and QLQ-OV28 instruments were applied to women with OC attending a cancer center in Mexico. The usual psychometric analyses were performed; the Spearman's method was used for correlation analysis, reliability analysis with the Cronbach's alpha, known-group comparisons with the Kruskal-Wallis test, responsiveness was tested employing repeated measures ANOVA, and the association of scale scores and overall survival (OS) were analyzed with the Kaplan-Meier method and Cox's model. RESULTS: Two hundred fifty-two women with OC were included in this cohort. The instruments were well accepted and compliance rates were high; patients responded both instruments in <30 min. The QLQ-OV28 internal consistency tests demonstrated good convergent (Correlation coefficients [CC] 0.154â0.694) and divergent validity (CC 0.003â0.69). Cronbach's α coefficients of six of eight scales of the QLQ-OV28 instruments were >0.7 (range, 0.567â0.857). Scales QLQ-OV28 instruments distinguished among clinically distinct groups of patients, particularly after basal serum albumin and basal Caâ125 levels. The evaluation of responsiveness demonstrated that two scales of the QLQ-OV28 were sensitive to change over time during induction chemotherapy. Six scales of the QLQ-OV28 were associated with OS. CONCLUSIONS: The Mexican-Spanish version of the QLQ-OV28 questionnaire is reliable and valid for the assessment of HRQL in patients with OC and can be broadly used in clinical trials.
Assuntos
Neoplasias Ovarianas/psicologia , Qualidade de Vida/psicologia , Feminino , Humanos , Idioma , México , Pessoa de Meia-Idade , Neoplasias Ovarianas/epidemiologia , Neoplasias Ovarianas/mortalidade , Prognóstico , Reprodutibilidade dos Testes , Inquéritos e Questionários , Análise de SobrevidaRESUMO
An amendment to this paper has been published and can be accessed via a link at the top of the paper.