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OBJECTIVE: This study aims to assess the patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS) as a patient-reported outcome measure (PROM) for pain assessment in a military population. DESIGN: A critical evaluation of the DVPRS was conducted, considering its fit-for-purpose as a PROM and its patient-centeredness using the National Health Council's Rubric to Capture the Patient Voice. SETTING: The study focused on the use of the DVPRS within the Department of Defense (DoD) and Veterans Health Administration (VA) healthcare settings. SUBJECTS: The DVPRS was evaluated based on published studies and information provided by measure developers. The assessment included content validity, reliability, construct validity, and ability to detect change. Patient-centeredness and patient engagement were assessed across multiple domains. METHODS: Two independent reviewers assessed the DVPRS using a tool/checklist/questionnaire, and any rating discrepancies were resolved through consensus. The assessment included an evaluation of psychometric properties and patient-centeredness based on established criteria. RESULTS: The DVPRS lacked sufficient evidence of content validity, with no patient involvement in its development. Construct validity was not assessed adequately, and confirmatory factor analysis was not performed. Patient-centeredness and patient engagement were also limited, with only a few domains showing meaningful evidence of patient partnership. CONCLUSIONS: The DVPRS as a PROM for pain assessment in the military population falls short in terms of content validity, construct validity, and patient-centeredness. It requires further development and validation, including meaningful patient engagement, to meet current standards and best practices for PROMs.
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Veteranos , Humanos , Psicometría , Dimensión del Dolor , Reproducibilidad de los Resultados , Dolor , Participación del Paciente , Medición de Resultados Informados por el PacienteRESUMEN
Social capital has been conceptualized as features of social organization, such as networks, and norms that facilitate coordination and cooperation for mutual benefit. Because of long-standing anti-Black structural oppression in the United States, social capital may be associated with health differently for Black people than for other racial/ethnic groups. Our aim was to examine the psychometric properties of social capital indicators, comparing responses from Black and White people to identify whether there is differential item functioning (DIF) in social capital according to race. DIF examines how items are related to a latent construct and whether this relationship differs across groups such as different racial groups. We used data from respondents to the Southeastern Pennsylvania Household Health Survey in 2004, who lived in Philadelphia (n = 2,048), a city with a large Black population. We used item response theory analysis to test for racial DIF. We found DIF across the items, indicating measurement error, which could be related to the way these items were developed (i.e., based on cultural assumptions tested in mainstream White America). Hence, our findings underscore the need to interrogate the assumptions that underly existing social capital items through an equity-based lens, and to take corrective action when developing new items to ensure that they are racially and culturally congruent.
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Equidad en Salud , Capital Social , Humanos , Negro o Afroamericano , Psicometría , Encuestas y Cuestionarios , Estados Unidos , BlancoRESUMEN
During the coronavirus disease 2019 (COVID-19) pandemic, the Brazilian long-term care (LTC) sector faced many challenges, which accentuated other common issues experienced by persons living with dementia (PLWD). The current pilot study evaluated staff perspectives regarding the care of institutionalized PLWD during the COVID-19 pandemic. Using an online survey, we collected the perspectives of 24 workers from seven long-term care facilities (LTCFs) located in São Paulo State, Brazil, about the impact of COVID-19 in caring for PLWD. Results highlight concerns about challenges related to following precautionary measures and the negative effects of social distancing on PLWD. Aspects related to workforce and staffing and person-centered care approaches were recognized by staff as important to provide good care for PLWD. Future research is needed to consider how to support LTCFs in achieving a balance between the protection and well-being of PLWD. [Journal of Gerontological Nursing, 49(5), 45-52.].
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COVID-19 , Demencia , Humanos , Cuidados a Largo Plazo , Pandemias/prevención & control , Brasil , Proyectos Piloto , Demencia/epidemiologíaRESUMEN
INTRODUCTION: This study examined patterns of initial transdermal fentanyl (TDF) claims among US commercially insured patients and explored the risk of 30-day hospitalization among patients with and without prior opioid exposure necessary to produce tolerance. DESIGN: A retrospective cohort study of initial outpatient TDF prescriptions. SETTING: A 10% random sample of commercially insured enrollees within the IQVIA Health Plan Claims Database (formerly known as PharMetrics Plus). SUBJECTS: Individuals with a claim for TDF between 2007 and 2015. METHODS: The primary exposure was a new transdermal fentanyl claim, and the primary outcome was guideline concordance based on time and dose exposure. RESULTS: Among the 24,770 patients in the cohort, 4,848 (20%) patients had sufficient time exposure to opioids before TDF. Among those with sufficient time exposure, 3,971 (82%) had adequate opioid exposure based on the US Food and Drug Administration (FDA) package insert dosing guidance. Overall, 3,971 of the 24,770 (16%) patients received guideline-consistent TDF. An exploratory analysis of 30-day hospitalization after a TDF claim did not detect a difference in odds between guideline-consistent or -inconsistent groups when adjusted for variables known to influence the risk of opioid-induced respiratory depression. CONCLUSIONS: A majority of patients met FDA opioid dose thresholds for TDF but had insufficient time exposure based on package insert recommendations for tolerance. Exploratory analysis did not detect a difference in odds for all-cause hospitalization or respiratory-related 30-day hospitalization between guideline-consistent or -inconsistent TDF claims. Prescribers should continue to adhere to FDA TDF labeling, although certain aspects of the labeling should be reevaluated or clarified.
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Analgésicos Opioides , Fentanilo , Administración Cutánea , Analgésicos Opioides/uso terapéutico , Tolerancia a Medicamentos , Humanos , Estudios RetrospectivosRESUMEN
OBJECTIVES: In recent years, there has been increasing recognition of the need to assess treatment benefit from the patient's perspective. The extent of patient-reported outcome (PRO) data included in labeling for rare disease treatment is largely unknown. The objective of this study was to review trends over time for PRO-based labeling granted by the US Food and Drug Administration (FDA) for orphan drugs. STUDY DESIGN: Review of FDA package inserts. METHODS: Products included in this analysis were all new molecular entities (NMEs) and biologic license applications (BLAs) with orphan designations approved by the FDA from 2002 through 2017. For identified products, package inserts were reviewed to determine the number and type of PRO claim(s) granted, endpoint status, and PRO measure named. Two trends were analyzed: (1) over all years 2002 to 2017 and (2) 2002 to 2017 stratified into 3 periods (before draft FDA PRO guidance [2006], between draft and final guidance release, and after final guidance [2009] release. RESULTS: A total of 156 NMEs and BLAs with orphan designations were approved between 2002 and 2017. Of these, 13 products (8.3%) had PRO-based labeling, and 7 of 13 were symptom-related. The percent of orphan drugs approved with PRO-based labeling between 2002 and 2005, 2006 and 2008, and 2009 and 2017 was 0, 10.5, and 9.9, respectively. CONCLUSIONS: In FDA-approved labeling for orphan therapies, PRO measures used as primary and secondary endpoints increased after draft FDA PRO guidance release but remained relatively low thereafter. It is important to understand barriers to PRO measure use to ensure that treatments capture perspectives of patients with rare diseases.
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Producción de Medicamentos sin Interés Comercial/estadística & datos numéricos , Medición de Resultados Informados por el Paciente , Etiquetado de Productos/estadística & datos numéricos , United States Food and Drug Administration/normas , Aprobación de Drogas , Humanos , Producción de Medicamentos sin Interés Comercial/normas , Rendimiento Físico Funcional , Etiquetado de Productos/normas , Calidad de Vida , Enfermedades Raras/tratamiento farmacológico , Índice de Severidad de la Enfermedad , Estados UnidosRESUMEN
BACKGROUND: To study Health related quality of life (HRQoL) of a sample of kindergarten children with migration background. METHODS: Five kindergartens in Frankfurt/Main and Darmstadt (Germany) participated. HRQoL was measured with the Kiddy-KINDL (KK) in 3 to 5 year old children. We examined the associations of HRQoL with socio-demographic variables, positive development and resilience, socio-emotional and motor development. Linear regression models were applied to examine differences in HRQoL between migrant and native-born German children. RESULTS: The response rate was 90.5% (N = 283). The children had predominantly migrant background (81.35%). Perceived health was slightly higher in migrants (69.85, SD 17.00) compared to native-born German children (68.33, SD 17.31, p > 0.05), even though migrant children were characterized by a lower socio-economic status (p < 0.01). CONCLUSIONS: Results suggest that HRQoL at early ages in our study exhibits a different pattern than reported previously in studies among older individuals. We attribute the discrepancy partly to a possible changing pattern of migration in Europe with more migrants capable to migrate with healthy profiles, and to the age of our population. Our findings underscore the need to study the life course trajectory of HRQoL among young immigrants and replication in representative samples.
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Emigrantes e Inmigrantes , Calidad de Vida , Preescolar , Etnicidad , Femenino , Alemania/epidemiología , Humanos , Masculino , Análisis de Regresión , Servicios de Salud Escolar/tendencias , Instituciones Académicas , Factores SocioeconómicosRESUMEN
OBJECTIVES: To evaluate the association of state-level policies on receipt of opioid regimens informed by Centers for Disease Control and Prevention (CDC) morphine milligram equivalent (MME)/day recommendations. DESIGN: A retrospective cohort study of new chronic opioid users (NCOUs). SETTING: Commercially insured plans across the United States using IQVIA PharMetrics® Plus for Academics database with new chronic use between January 2014 and March 2015. PARTICIPANTS: NCOUs with ≥60-day coverage of opioids within a 90-day period with ≥30-day opioid-free period prior to the date of the first qualifying opioid prescription. INTERVENTIONS: State-level policies including Prescription Drug Monitoring Program (PDMP) robustness and cannabis policies involving the presence of medical dispensaries and state-wide decriminalization. MAIN OUTCOME MEASURES: NCOUs were placed in three-tiered risk-based average MME/day thresholds: low (>0 to <50), medium (≥50 to <90), and high (≥90). Multinomial logistic regression was used to estimate the association of state-level policies with the thresholds while adjusting for relevant patient-specific factors. RESULTS: NCOUs in states with medium or high PDMP robustness had lower odds of receiving medium (adjusted odds ratio [AOR] 0.74; 95 percent confidence interval [CI]: 0.62-0.69) and high (AOR 0.74; 95 percent CI: 0.59-0.92) thresholds. With respect to cannabis policies, NCOUs in states with medical cannabis dispensaries had lower odds of receiving high (AOR 0.75; 95 percent CI: 0.60-0.93) thresholds, while cannabis decriminalization had higher odds of receiving high (AOR 1.24; 95 percent CI: 1.04-1.49) thresholds. CONCLUSION: States with highly robust PDMPs and medical cannabis dispensaries had lower odds of receiving higher opioid thresholds, while cannabis decriminalization correlated with higher odds of receiving high opioid thresholds.
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Analgésicos Opioides , Centers for Disease Control and Prevention, U.S. , Trastornos Relacionados con Opioides , Humanos , Analgésicos Opioides/uso terapéutico , Estados Unidos , Estudios Retrospectivos , Masculino , Femenino , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/prevención & control , Adulto , Persona de Mediana Edad , Programas de Monitoreo de Medicamentos Recetados/legislación & jurisprudencia , Política de Salud/legislación & jurisprudencia , Marihuana Medicinal/uso terapéutico , Adulto JovenRESUMEN
A key part of any effort to ensure informed health care decision-making among the public is access to reliable and relevant health-related information. We conducted focus groups with women from three generations across the Baltimore-Washington metropolitan area to explore their information-seeking motivations, perceptions, challenges, and preferences regarding three FDA-regulated products: drugs, vaccines, and medical devices. The youngest generation discussed seeking health information for their children; the other two sought information for their own needs. All participants noted that finding health information appropriate to their reading level was a challenge, as was identifying reliable sources of information. All generations identified in-person and live interactions as their preferred method of communication and health care providers as their preferred source for information. All three generations recognized the usefulness of websites, and the two older generations acknowledged the advantages of brochures. Our findings suggest approaches the FDA could consider to improve communications: (a) supporting in-person and live health information interactions; (b) leveraging the agency's standing with the public to highlight it as a leading source of validated health information; (c) increasing the FDA website's visibility in internet searches and making its navigation easier; and (d) using multi-pronged approaches and media for various audiences.
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Comunicación en Salud , Conducta en la Búsqueda de Información , Niño , Humanos , Femenino , Investigación Cualitativa , Grupos Focales , Salud de la MujerRESUMEN
OBJECTIVE: To evaluate the impact of recent changes to the Centers for Disease Control and Prevention (CDC) morphine milligram equivalent (MME)/day threshold recommendations on healthcare utilization. DESIGN: A retrospective cohort study of new chronic opioid users (NCOUs). SETTING: Commercially insured plans across the United States using IQVIA PharMetrics® Plus for Academics database with new use between January 2014 and March 2015. PATIENTS: NCOUs with ≥60-day coverage of opioids within a 90-day period with ≥30-day opioid-free period prior to the date of the first qualifying opioid -prescription. INTERVENTIONS: NCOU categorized by the CDC three-tiered risk-based average MME/day thresholds: low (>0 to <50), medium (≥50 to <90), and high (≥90). MAIN OUTCOME MEASURES: Multivariable logistic regression was used to calculate adjusted odds of incurring an acute care encounter (ACE) (all-cause and opioid-related) between the thresholds (adjusted odds, 95 percent confidence interval). RESULTS: In adjusted analyses, when compared to low threshold, there was no difference in the odds of all-cause ACE across the medium (1.01, 0.94-1.28) and high (1.01, 0.84-1.22) thresholds. When compared to low threshold, a statistically insignificant increase was observed when evaluating opioid-related ACE among medium (1.86, 0.86-4.02) and high (1.51, 0.65-3.52) thresholds. CONCLUSIONS: There was no difference in odds of an all-cause or opioid-related ACE associated with the thresholds. Early-intervention programs and policies exploring reduction of MME/day among NCOUs may not result in short-term reduction in all-cause or opioid-related ACEs. Further assessment of potential long-term reduction in ACEs among this cohort may be insightful.
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Analgésicos Opioides , Endrín/análogos & derivados , Pautas de la Práctica en Medicina , Humanos , Estados Unidos , Analgésicos Opioides/uso terapéutico , Estudios Retrospectivos , Prescripciones de MedicamentosRESUMEN
PURPOSE: We investigated the effect of parents' mental health, life events, and home life (among other factors) on adolescents'/youths' mental health, whether such an effect varies when several variables are assessed jointly, and also whether the informant source of the mental health problem modifies the estimations. METHODS: We studied a representative sample of 454 Spanish adolescents/youths studied longitudinally (2 assessments, 3 years apart). We considered factors associated with adolescents'/youths' mental health (conduct, emotional, and hyperactivity scores [SDQ]): risk factors (parents' mental health and life events) and mediators (social and financial support). Structural equation modeling was applied. We constructed two models: (a) with parents' SDQ responses and (b) with self-reported SDQ responses (in a subsample of N = 260). RESULTS: Model fit was adequate for parents' appraisal. Parents' mental health (p < 0.05) and undesirable life events (p < 0.05) were the most important risk factors. The same model showed poorer fit when self-reported measures were used. Home life exerted a stronger protective effect on adolescents'/youths' mental health when reported by adolescents/youths. The negative effect of parents' mental health was significantly protected by home life in emotional [-0.14 (0.07)] and hyperactivity scores [-0.2 (0.08)]. CONCLUSIONS: Even in the presence of other factors, parents' mental health has an important effect on adolescents'/youths' mental health. Good levels of home life are protective, especially when adolescents'/youths' mental health is self-reported.
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Estado de Salud , Salud Mental , Padres/psicología , Psicología del Adolescente , Calidad de Vida/psicología , Medio Social , Adolescente , Trastorno por Déficit de Atención con Hiperactividad/epidemiología , Niño , Trastorno de la Conducta/epidemiología , Composición Familiar , Femenino , Humanos , Acontecimientos que Cambian la Vida , Estudios Longitudinales , Masculino , Análisis de Regresión , Factores de Riesgo , Trastorno de la Conducta Social/epidemiología , Factores Socioeconómicos , España/epidemiología , Encuestas y CuestionariosRESUMEN
The coronavirus pandemic has drastically impacted many groups that have been socially and economically marginalized such as Hispanics/Latinos in the United States (U.S.). Our aim was to understand how bonding social capital, bridging social capital, and trust played a role in Hispanics/Latinos over the course of the COVID-19 outbreak, as well as explore the negative consequences of social capital. We performed focus group discussions via Zoom (n = 25) between January and December 2021 with Hispanics/Latinos from Baltimore, MD, Washington, DC, and New York City, NY. Our findings suggest that Hispanics/Latinos experienced bridging and bonding social capital. Of particular interest was how social capital permeated the Hispanic/Latino community's socioeconomic challenges during the pandemic. The focus groups revealed the importance of trust and its role in vaccine hesitancy. Additionally, the focus groups discussed the dark side of social capital including caregiving burden and spread of misinformation. We also identified the emergent theme of racism. Future public health interventions should invest in social capital, especially for groups that have been historically marginalized or made vulnerable, and consider the promotion of bonding and bridging social capital and trust. When prospective disasters occur, public health interventions should support vulnerable populations that are overwhelmed with caregiving burden and are susceptible to misinformation.
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COVID-19 , Capital Social , Humanos , Estados Unidos/epidemiología , COVID-19/epidemiología , Pandemias , Estudios Prospectivos , Hispánicos o LatinosRESUMEN
Objectives: To examine the relationship of volunteering with cognitive activity, social activity, and physical activity among older adults and, ultimately, with later cognitive functioning across different time periods. Methods: We used individual responding to three waves of the US Health and Retirement Study panel data from 2008, 2012, and 2016 (n = 2,862). Self-reported questionnaires were used to assess annual volunteering frequency (non volunteering, volunteering <100 h and ≥100 h), and an adapted version of the Telephone Interview for Cognitive Status (TICS) was used to assess memory, mental processing, knowledge, language, and orientation. A structural equation model was estimated to assess effects on cognitive functioning throughout waves. Results: Those participants that were part of volunteering activities in 2012 showed an increase between 2008 and 2012 in moderate physical activity (ß = 0.19, P < 0.001 for those volunteering less than 100 h and ß = 0.21, P < 0.001 for those volunteering at least 100 h), increase in social activity (ß = 0.10, P = 0.052 for those volunteering less than 100 h and ß = 0.12, P = 0.018 for those volunteering at least 100 h) and increase in higher cognitive activity (ß = 0.13, P < 0.001 for those volunteering at least 100 h), compared to participants who did not volunteer. Higher levels of cognitive activity in 2008 and 2012 were associated with higher cognitive functioning on the following waves (ß = 0.66 and ß = 0.60, P < 0.001, respectively). Discussion: Volunteering is a modifiable activity that can be increased to bolster cognitive functioning in older adulthood, primarily mediated by increased cognitive activity.
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HIV testing rates vary by race and ethnicity. Whether social capital indicators are related to HIV testing and whether these associations differ by race or ethnicity is unknown. Multivariable analysis was used to examine whether social capital (collective engagement and civic and social participation), including social cohesion (trust in neighbors, neighbors willing to help, feelings of belongingness) were associated with testing for HIV in the past 12 months. Participants were white, Black or African American, and Hispanic/Latino adults ages 18 to 44 (N = 2823) from the general population, in Philadelphia, PA who participated in the Southeastern Pennsylvania Household Health Surveys 2010 and 2012. Overall HIV testing in this sample was 42%, and was higher among women, and Black compared to white people. Mean social capital scores were significantly highest among whites. Greater trust in neighbors was associated with lower odds of testing for HIV (adjusted Odds Ratio[aOR]:0.61, 95% CI = 0.49-0.74), and this relationship varied by race/ethnicity, with stronger inverse associations among Hispanic/Latino (aOR = 0.43, p < 0.001) and white adults (aOR = 0.50, p < -0.001) than among Black adults (aOR = 0.75, p < 0.05). Greater neighborhood belongingness (aOR = 1.31, 95% CI = 1.11-1.54) and working together to improve the neighborhood (aOR = 1.33, 95%CI = 1.03-1.73) were associated with higher odds of testing for HIV. Different indicators of social capital were associated with higher as well as lower odds of testing for HIV. These patterns did not vary statistically by race or ethnicity. HIV testing prevention interventions will need to address social capital in design and implementation strategies.
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BACKGROUND: The 2009 Food and Drug Administration (FDA) patient-reported outcome (PRO) guidance outlines characteristics of rigorous PRO-measure development. There are a number of widely used PRO measures for Systemic Lupus Erythematosus (SLE), but it is unknown how well the development processes of SLE PRO measures align with FDA guidance; including updated versions. The objective of this study was to assess how well the LupusQoL and LupusPRO, and corresponding updated versions, LupusQoL-US and LupusPROv1.8, align with Food and Drug Administration (FDA) 2009 patient-reported outcome (PRO) guidance. METHODS: LupusQoL and LupusPRO were selected as the most widely studied and used Lupus PROs in the UK and US. Original (LupusQoL (2007) and LupusQoL-US (2010)) and revised (LupusPROVv1.7 (2012) and LupusPROv1.8 (2018)) versions were reviewed. We used FDA PRO guidance to create evaluation criteria for key components: target population, concepts measured, measurement properties, documentation across the phases of content validity (item-generation and cognitive interviewing, separately) and other psychometric-property testing. Two reviewers abstracted data independently, compared results, and resolved discrepancies. RESULTS: For all measures, the target population was unclear as population characteristics (e.g., ethnicity, education, disease severity) varied, and/or were not consistently reported or not considered across the three phases (e.g., LupusQoL item-generation lacked male involvement, LupusPRO cognitive-interviewing population characteristics were not reported). The item-generation phase for both original measures was conducted with concepts elicited via patient-engagement interviews and item derivation from experts. Cognitive interviewing was conducted via patient feedback with limited item-tracking for original measures. In contrast, the revised measures assumed content validity. Other psychometric testing recommendations (reliability, construct validity, ability to detect change) were reported for both original and revised measures, except for ability to detect change for revised measures. CONCLUSIONS: The SLE PRO measures adhere to some but not all FDA PRO guidance recommendations. Limitations in processes and documentation of the study population, make it unclear for which target population(s) the current Lupus measures are fit-for-purpose.
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INTRODUCTION: This study quantifies costs associated with comorbid conditions among adults diagnosed with chronic obstructive pulmonary disease (COPD) who experience acute exacerbations (AECOPD) needing inpatient hospitalization. METHODS: This retrospective cohort study used 2006-2015 IQVIA PharMetrics® Plus data, a health plan claims database. Patients aged 40-64 years, with AECOPD, defined as an inpatient hospitalization for a COPD-related diagnosis were included. The impact of comorbidities on AECOPD costs (costs of the COPD-related inpatient stay plus healthcare services used 30 days post-discharge) was determined using multivariable regression. The models adjusted for clinical complications, previous utilization, age, sex, region, year, length of hospitalization, and season of admission. RESULTS: Among these COPD patients, 89.5% had at least 1 comorbidity. The mean cost for AECOPD was 2015 US $19,687 (SD: 27,035, median: 11,539). Congestive heart failure, lipid disorders, cancer, and presence of any of the 10 most frequent comorbidities were associated with $1,921 (95% confidence interval (CI): 977-2,866), $1,619 (95% CI: 967-2,272), $8,347 (95% CI: 7,236-9,458), and $4,433 (95% CI: 3,598-5,268) higher costs, respectively than corresponding individuals without these comorbid conditions. Patients with depressive disorders were associated with $1,592 (95% CI: 828-2,355) lower costs compared to those without depressive disorders. CONCLUSION: COPD comorbidity imposes a significant economic burden on AECOPD.
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Estrés Financiero , Enfermedad Pulmonar Obstructiva Crónica , Adulto , Cuidados Posteriores , Comorbilidad , Progresión de la Enfermedad , Hospitalización , Humanos , Alta del Paciente , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/terapia , Estudios RetrospectivosRESUMEN
(1) Background: Discrepancies between children's self-reports and their parents' reports on mental health indicators are associated with measurement errors or informant bias. However, they are a valuable tool in understanding the course of child psychopathology. This study aims to determine the level of discrepancies between parents' perceptions and children's self-reports in mental health indicators in Northern Chile. (2) Methods: A System of Evaluation of Children and Adolescents self-report (Sistema de Evaluación de Niños y Adolescentes, SENA) was responded to by 408 students between 8 and 13 years old and their parents. (3) Results: Children reported a significantly higher frequency of emotional problems, defiant behavior, and executive functions as compared to their parents' responses. (4) Conclusions: There is a disjunction between the report of parents and children, which could originate in poor family communication.
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PURPOSE: To compare the predictive ability of mapping algorithms derived using cross-sectional and longitudinal data. METHODS: This methodological assessment used data from a randomized controlled noninferiority trial of patients with low-risk prostate cancer, conducted by NRG Oncology (ClinicalTrials.gov identifier: NCT00331773), which examined the efficacy of conventional schedule versus hypofractionated radiation therapy (three-dimensional conformal external beam radiation therapy/IMRT). Health-related quality-of-life data were collected using the Expanded Prostate Cancer Index Composite (EPIC), and health utilities were obtained using EuroQOL-5D-3L (EQ-5D) at baseline and 6, 12, 24, and 60 months postintervention. Mapping algorithms were estimated using ordinary least squares regression models through five-fold cross-validation in baseline cross-sectional data and combined longitudinal data from all assessment periods; random effects specifications were also estimated in longitudinal data. Predictive performance was compared using root mean square error. Longitudinal predictive ability of models obtained using baseline data was examined using mean absolute differences in the reported and predicted utilities. RESULTS: A total of 267 (and 199) patients in the estimation sample had complete EQ-5D and EPIC domain (and subdomain) data at baseline and at all subsequent assessments. Ordinary least squares models using combined data showed better predictive ability (lowest root mean square error) in the validation phase for algorithms with EPIC domain/subdomain data alone, whereas models using baseline data outperformed other specifications in the validation phase when patient covariates were also modeled. The mean absolute differences were lower for models using EPIC subdomain data compared with EPIC domain data and generally decreased as the time of assessment increased. CONCLUSION: Overall, mapping algorithms obtained using baseline cross-sectional data showed the best predictive performance. Furthermore, these models demonstrated satisfactory longitudinal predictive ability.
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Neoplasias de la Próstata , Calidad de Vida , Algoritmos , Estudios Transversales , Humanos , Masculino , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/terapia , Encuestas y CuestionariosRESUMEN
The rapidly evolving coronavirus pandemic has drastically altered the economic and social lives of people throughout the world. Our overall goal is to understand the mechanisms through which social capital shaped the community response to the pandemic on the island of Menorca, Spain, which was under a strict lockdown in 2020. Between April and June 2020, we performed qualitative interviews (n = 25) of permanent residents of the island. From the findings, it is evident that social capital is an important resource with the capacity to organize help and support. However, the dark sides of social capital, with lack of social cohesion and lack of trust, also emerged as an important negative issue. We identified sources of tension that were not resolved, as well as important sociodemographic differences that are primary drivers for health inequalities. The investment in social networks and social capital is a long-term need that should consider sociodemographic vulnerability.