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1.
Res Sq ; 2024 Jun 06.
Artículo en Inglés | MEDLINE | ID: mdl-38883796

RESUMEN

Background: Retention of study participants in observational studies is essential to maintaining the representativeness of the population, minimizing selection bias, and assuring sufficient statistical power. The aim of this report is to describe the structures and strategies used to retain participants in The Environmental Determinants of Diabetes in the Young (TEDDY) Study, an observational study of children at increased genetic risk for type 1 diabetes followed in an intense protocol with frequent clinic visits from birth until age 15. Methods: A systematic review of methodologies used to retain research subjects identified four domains: barrier reduction strategies; community building strategies; follow-up/reminder strategies; and tracing strategies. Independent reviewers categorized the retention strategies implemented by the TEDDY Study into each of these domains. Strategies not fitting into any of these categories were placed into a fifth category unique to TEDDY. Results: TEDDY identified over one hundred retention strategies used during the 15 years of follow-up; most could be categorized in these domains. Those unique to TEDDY included (1) study organization and structures to support retention; (2) efforts to meet the changing developmental needs of the TEDDY population, (3) implementation of efforts to address protocol challenges in real-time; and (4) employment of a re-engagement protocol for those who had dropped out of the study. Conclusion: Pediatric cohort studies should include strategies, structures, and resources addressing retention at the study's initiation. It is recommended that child and parent engagement in addition to the developmental needs of the child be an integrated focus of all strategies. Putting mechanisms in place to address protocol and retention challenges in real time would facilitate effectively addressing challenges as they arise. Trial registration: ClinicalTrials.gov Identifier: NCT00279318.

2.
Diabetes Care ; 46(12): 2155-2161, 2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-37673098

RESUMEN

OBJECTIVE: To assess anxiety and risk perception among parents whose children screened positive for islet autoantibodies, indicating elevated risk for type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: The Autoimmunity Screening for Kids (ASK) study identified 319 children age 1 to 17 years at risk for T1D via screening for islet autoantibodies; 280 children with confirmed islet autoantibodies and their caregivers enrolled in a follow-up education and monitoring program to prevent diabetic ketoacidosis at diagnosis. Parents completed questionnaires at each monitoring visit, including a 6-item version of the State Anxiety Inventory (SAI), to assess anxiety about their child developing T1D, and a single question to assess risk perception. RESULTS: At the first ASK follow-up monitoring visit, mean parental anxiety was elevated above the clinical cutoff of 40 (SAI 46.1 ± 11.2). At the second follow-up monitoring visit (i.e., visit 2), mean anxiety remained elevated but started to trend down. Approximately half (48.9%) of parents reported their child was at increased risk for T1D at the initial follow-up monitoring visit (visit 1). Parents of children with more than one islet autoantibody and a first-degree relative with T1D were more likely to report their child was at increased risk. CONCLUSIONS: Most parents of autoantibody-positive children have high anxiety about their child developing T1D. Information about the risk of developing T1D is difficult to convey, as evidenced by the wide range of risk perception reported in this sample.


Asunto(s)
Diabetes Mellitus Tipo 1 , Islotes Pancreáticos , Niño , Humanos , Lactante , Preescolar , Adolescente , Diabetes Mellitus Tipo 1/epidemiología , Autoanticuerpos , Padres , Ansiedad/diagnóstico , Percepción
3.
Diabetes Care ; 45(2): 365-371, 2022 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-34880069

RESUMEN

OBJECTIVE: Children identified with stage 1 type 1 diabetes are at high risk for progressing to stage 3 (clinical) diabetes and require accurate monitoring. Our aim was to establish continuous glucose monitoring (CGM) metrics that could predict imminent progression to diabetes. RESEARCH DESIGN AND METHODS: In the Autoimmunity Screening for Kids study, 91 children who were persistently islet autoantibody positive (median age 11.5 years; 48% non-Hispanic White; 57% female) with a baseline CGM were followed for development of diabetes for a median of 6 (range 0.2-34) months. Of these, 16 (18%) progressed to clinical diabetes in a median of 4.5 (range 0.4-29) months. RESULTS: Compared with children who did not progress to clinical diabetes (nonprogressors), those who did (progressors) had significantly higher average sensor glucose levels (119 vs. 105 mg/dL, P < 0.001) and increased glycemic variability (SD 27 vs. 16, coefficient of variation, 21 vs. 15, mean of daily differences 24 vs. 16, and mean amplitude of glycemic excursions 43 vs. 26, all P < 0.001). For progressors, 21% of the time was spent with glucose levels >140 mg/dL (TA140) and 8% of time >160 mg/dL, compared with 3% and 1%, respectively, for nonprogressors. In survival analyses, the risk of progression to diabetes in 1 year was 80% in those with TA140 >10%; in contrast, it was only 5% in the other participants. Performance of prediction by receiver operating curve analyses showed area under the curve of ≥0.89 for both individual and combined CGM metric models. CONCLUSIONS: TA140 >10% is associated with a high risk of progression to clinical diabetes within the next year in autoantibody-positive children. CGM should be included in the ongoing monitoring of high-risk children and could be used as potential entry criterion for prevention trials.


Asunto(s)
Diabetes Mellitus Tipo 1 , Autoinmunidad , Benchmarking , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea , Niño , Preescolar , Diabetes Mellitus Tipo 1/diagnóstico , Femenino , Hemoglobina Glucada/análisis , Humanos , Lactante , Recién Nacido , Masculino
4.
Am J Gastroenterol ; 116(1): 180-187, 2021 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-32701732

RESUMEN

INTRODUCTION: The Autoimmunity Screening for Kids (ASK) study is a large scale pediatric screening study in Colorado for celiac disease (CD) and type 1 diabetes. This is a report of the CD outcomes for the first 9,973 children screened through ASK. METHODS: ASK screens children aged 1-17 years for CD using 2 highly sensitive assays for tissue transglutaminase autoantibodies (TGA): a radiobinding (RBA) assay for IgA TGA and an electrochemiluminescence (ECL) assay that detects all TGA isotypes. Children who test positive on either assay are asked to return for confirmatory testing. Those with a confirmed RBA TGA level ≥ 0.1 (twice the upper limit of normal) are referred to the Colorado Center for Celiac Disease for further evaluation; all others are referred to primary care. RESULTS: Of the initial 9,973 children screened, 242 children were TGA+ by any assay. Of those initially positive, 185 children (76.4%) have completed a confirmation blood draw with 149 children (80.5%) confirming positive by RBA TGA. Confirmed RBA TGA+ was associated with a family history of CD (odds ratio [OR] = 1.83; 95% confidence interval 1.06-3.16), non-Hispanic white ethnicity (OR = 3.34; 2.32-4.79), and female sex (OR = 1.43; 1.03-1.98). Gastrointestinal symptoms of CD, assessed at the initial screening, were reported equally often among the RBA TGA+ vs TGA- children (32.1% vs 30.5%, P = 0.65). DISCUSSION: The initial results of this ongoing mass-screening program confirm a high prevalence of undiagnosed CD autoimmunity in a screened US population. Symptoms at initial screening were not associated with TGA status (see Visual abstract, Supplementary Digital Content 5, http://links.lww.com/AJG/B587).


Asunto(s)
Autoanticuerpos/inmunología , Enfermedad Celíaca/diagnóstico , Proteínas de Unión al GTP/inmunología , Transglutaminasas/inmunología , Adolescente , Enfermedades Asintomáticas , Enfermedad Celíaca/inmunología , Niño , Preescolar , Técnicas de Diagnóstico por Radioisótopo , Técnicas Electroquímicas , Femenino , Humanos , Inmunoglobulina A/inmunología , Inmunoglobulina D/inmunología , Inmunoglobulina E/inmunología , Inmunoglobulina G/inmunología , Inmunoglobulina M/inmunología , Lactante , Masculino , Tamizaje Masivo , Proteína Glutamina Gamma Glutamiltransferasa 2 , Pruebas Serológicas
5.
Diabetes Care ; 43(7): 1496-1503, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32327420

RESUMEN

OBJECTIVE: To assess the costs and project the potential lifetime cost-effectiveness of the ongoing Autoimmunity Screening for Kids (ASK) program, a large-scale, presymptomatic type 1 diabetes screening program for children and adolescents in the metropolitan Denver region. RESEARCH DESIGN AND METHODS: We report the resource utilization, costs, and effectiveness measures from the ongoing ASK program compared with usual care (i.e., no screening). Additionally, we report a practical screening scenario by including utilization and costs relevant to routine screening in clinical practice. Finally, we project the potential cost-effectiveness of ASK and routine screening by identifying clinical benchmarks (i.e., diabetic ketoacidosis [DKA] events avoided, HbA1c improvements vs. no screening) needed to meet value thresholds of $50,000-$150,000 per quality-adjusted life-year (QALY) gained over a lifetime horizon. RESULTS: Cost per case detected was $4,700 for ASK screening and $14,000 for routine screening. To achieve value thresholds of $50,000-$150,000 per QALY gained, screening costs would need to be offset by cost savings through 20% reductions in DKA events at diagnosis in addition to 0.1% (1.1 mmol/mol) improvements in HbA1c over a lifetime compared with no screening for patients who develop type 1 diabetes. Value thresholds were not met from avoiding DKA events alone in either scenario. CONCLUSIONS: Presymptomatic type 1 diabetes screening may be cost-effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved HbA1c persist over long-run time horizons. As more data are collected from ASK, the model will be updated with direct evidence on screening effects.


Asunto(s)
Diabetes Mellitus Tipo 1/diagnóstico , Costos de la Atención en Salud , Tamizaje Masivo/economía , Adolescente , Autoanticuerpos/análisis , Autoanticuerpos/sangre , Niño , Preescolar , Colorado/epidemiología , Análisis Costo-Beneficio , Costos y Análisis de Costo , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/epidemiología , Cetoacidosis Diabética/economía , Cetoacidosis Diabética/epidemiología , Diagnóstico Precoz , Femenino , Hemoglobina Glucada/análisis , Costos de la Atención en Salud/estadística & datos numéricos , Costos de la Atención en Salud/tendencias , Humanos , Hipoglucemiantes/economía , Estudios Longitudinales , Masculino , Tamizaje Masivo/métodos , Años de Vida Ajustados por Calidad de Vida
6.
Dev Psychobiol ; 59(5): 658-667, 2017 07.
Artículo en Inglés | MEDLINE | ID: mdl-28555778

RESUMEN

Saliva offers a relatively noninvasive method for measuring analytes such as cortisol, holding particular promise for use in pediatric populations on a large scale if a rigorous collection protocol is feasible in diverse settings. The Environmental Determinants of Diabetes in the Young study protocol, conducted in centers in the United States, Sweden, Finland, and Germany, used salivary collection to assess cortisol level as a physiologic marker of stress. Saliva was collected using Sorbettes from subjects at 3.5, 4.5, and 5.5 years of age. Parents collected a morning sample, and staff collected pre- and post-blood draw samples. Feasibility was assessed based on protocol completion, adherence with instructions, factors affecting adherence, and sufficiency of saliva sample for cortisol determination. Collection of saliva samples in a diverse pediatric population is feasible. Establishing non-invasive and acceptable methods for collecting physiological parameters of stress will allow better exploration of determinants of health in this important population.


Asunto(s)
Hidrocortisona/análisis , Saliva/química , Manejo de Especímenes/métodos , Biomarcadores , Preescolar , Ritmo Circadiano/fisiología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Proyectos de Investigación
7.
Age Ageing ; 46(1): 96-100, 2017 01 06.
Artículo en Inglés | MEDLINE | ID: mdl-28181642

RESUMEN

Objective: We investigated the association between the peroxisome proliferator-activated receptor (PPAR)-gamma Pro12Ala polymorphism and cognitive decline in older adults. Methods: Participants from a population-based cohort of older Hispanic and non-Hispanic white adults (n = 492) were administered the Mini Mental State Examination (MMSE), a multi-domain cognitive screening tool, and the Behavioral Dyscontrol Scale (BDS), a measure of executive cognitive function, at baseline and at follow-up, an average of 22 months later. Multiple linear regression was used to investigate the association between the two cognitive test scores and the Pro12Ala polymorphism. Results: At baseline, presence of the Ala12 allele was not significantly associated with MMSE score (P = 0.62) nor with BDS score (P = 0.85). Heterogeneity was present for cognitive decline as measured by the MMSE among ethnic, sex and Ala12 allele status (P = 0.04 for three-way interaction term). Stratification by the cross-classification of sex and ethnicity revealed significantly greater declines in MMSE score among male Hispanic carriers of the Ala12 allele compared to male Hispanic non-carriers (decline = 4.0 versus 1.6 points; P = 0.02). A significant difference in decline between Ala12 carriers and non-carriers was not present among the other sex/ethnic groups. Conclusions: Carriers of the PPAR-γ Ala12 allele showed greater cognitive decline compared to non-carriers as detected by the MMSE but the risk varied across sex and ethnic groups. Male Ala12 carriers of Hispanic origin may be a high-risk group for cognitive decline.


Asunto(s)
Trastornos del Conocimiento/genética , Cognición , Envejecimiento Cognitivo/psicología , Hispánicos o Latinos/genética , PPAR gamma/genética , Polimorfismo de Nucleótido Simple , Población Blanca/genética , Factores de Edad , Anciano , Anciano de 80 o más Años , Trastornos del Conocimiento/diagnóstico , Trastornos del Conocimiento/etnología , Trastornos del Conocimiento/psicología , Femenino , Frecuencia de los Genes , Predisposición Genética a la Enfermedad , Humanos , Modelos Lineales , Masculino , Pruebas de Estado Mental y Demencia , Persona de Mediana Edad , Análisis Multivariante , Fenotipo , Factores de Riesgo , Factores Sexuales
8.
J Pediatr Psychol ; 41(3): 373-83, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26412232

RESUMEN

OBJECTIVE: To identify predictors of later study withdrawal among participants active in The Environmental Determinants of Diabetes in the Young (TEDDY) for 1 year. METHODS: Multiple logistic regression was used to discriminate 3,042 children active in TEDDY for the first 3 years from 432 children who withdrew in Years 2 or 3. Predictor variables were tested in blocks-demographic, maternal lifestyle behaviors, stress and child illness, maternal reactions to child's increased diabetes risk, in-study behaviors-and a final best model developed. RESULTS: Few demographic factors predicted study withdrawal. Maternal lifestyle behaviors, accuracy of the mother's risk perception, and in-study behaviors were more important. Frequent child illnesses were associated with greater study retention. CONCLUSIONS: Demographic measures are insufficient predictors of later study withdrawal among those active in a study for at least 1 year; behavioral/psychological factors offer improved prediction and guidance for the development of retention strategies.


Asunto(s)
Diabetes Mellitus Tipo 1/etiología , Estudios Epidemiológicos , Estilo de Vida , Madres/estadística & datos numéricos , Pacientes Desistentes del Tratamiento/estadística & datos numéricos , Preescolar , Diabetes Mellitus Tipo 1/genética , Femenino , Humanos , Lactante , Estudios Longitudinales , Masculino , Estudios Multicéntricos como Asunto , Factores de Riesgo
9.
J Diabetes Res ; 2016: 2720650, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26682228

RESUMEN

BACKGROUND: To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. METHODS: 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). RESULTS: Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. CONCLUSIONS: Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.


Asunto(s)
Recolección de Muestras de Sangre/psicología , Diabetes Mellitus Tipo 1/etiología , Pacientes Desistentes del Tratamiento/psicología , Preescolar , Diabetes Mellitus Tipo 1/sangre , Progresión de la Enfermedad , Femenino , Humanos , Lactante , Masculino , Factores Sexuales
10.
Pediatr Diabetes ; 17(6): 441-8, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-26251221

RESUMEN

OBJECTIVE: Type 1 diabetes (T1D) or celiac disease (CD) develops in at least 2% of the general population. Early detection of disease-specific autoimmunity and subsequent monitoring would be possible if screening tests were more widely available. Currently, screening for islet autoimmunity is available only in a research setting, and CD-specific autoimmunity screening is limited to those in high-risk groups. This study assessed the feasibility of incorporating T1D and CD autoantibody screening into a pediatric practice. METHODS: Patient engagement strategies, blood collection preference, blood sample volume, rate of autoantibody detection in the general population, and parental satisfaction were assessed. Over 5 weeks, research staff recruited 200 patients, aged 2-6 yr from two pediatric practices in the Denver area to be screened for islet autoantibodies (IAs) and the transglutaminase antibody. RESULTS: Of the 765 parents approached, 200 (26%) completed the same-day screening. Of the 565 subjects who did not complete the screening, 345 expressed interest, but were unable to make a participation decision. A finger stick, compared with a venous draw, was the preferred method of sample collection. Both methods yielded sufficient blood volume for autoantibody determination. IAs or the transglutaminase antibody were detected in 11 subjects. Parents expressed satisfaction with all aspects of participation. CONCLUSIONS: The results of this study suggest that it is feasible to conduct this type of screening in a pediatric clinic. Such screening could lead to increased disease awareness and the possible benefits that can result from early detection.


Asunto(s)
Diabetes Mellitus Tipo 1/diagnóstico , Tamizaje Masivo/psicología , Autoanticuerpos/sangre , Niño , Preescolar , Diabetes Mellitus Tipo 1/inmunología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Tamizaje Masivo/métodos , Pediatría , Transglutaminasas/inmunología
12.
Diabetes Care ; 37(2): 325-31, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24041684

RESUMEN

OBJECTIVE: Mothers of children at risk for type 1 diabetes report engaging in preventive behaviors. The purpose of this study is to further document these actions in an international, longitudinal sample and examine variables that predict whether mothers engage in these behaviors. RESEARCH DESIGN AND METHODS: This study examined an international sample (from Finland, Germany, Sweden, and the U.S.) from the naturalistic, longitudinal The Environmental Determinants of Diabetes in the Young (TEDDY) study, which tracked children genetically at risk for type 1 diabetes from birth to age 15 years. Mothers of 7,613 infants aged 6 months and 6,503 infants aged 15 months completed questionnaires assessing psychosocial factors and actions intended to prevent diabetes. RESULTS: Many mothers (29.9% at 6 months and 42.8% at 15 months) reported engaging in a behavior intended to prevent type 1 diabetes, with the largest percentages (20.9-29.2%) reporting making changes to their child's diet (e.g., reducing the consumption of sweets and carbohydrates). Factors related to engaging in preventive behaviors include older maternal age; higher maternal education; minority status; having only one child; having a first-degree relative with type 1 diabetes; being from a country other than Sweden; having an accurate perception of the child's increased risk for developing diabetes; having postpartum depression, maternal anxiety, and worry about the risk of diabetes; and believing that diabetes can be prevented. CONCLUSIONS: The findings of this study suggest that many mothers engage in actions to prevent diabetes and highlight the importance of tracking these behaviors to ensure the validity of naturalistic observational studies.


Asunto(s)
Diabetes Mellitus Tipo 1/prevención & control , Madres/psicología , Conducta de Reducción del Riesgo , Adulto , Ansiedad/psicología , Dieta , Femenino , Alemania , Humanos , Lactante , Masculino , Factores de Riesgo , Encuestas y Cuestionarios
13.
J Behav Med ; 37(2): 332-42, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23329423

RESUMEN

Cardiometabolic risk factors, including hypertension, dyslipidemia, central obesity, insulin resistance and diabetes are linked to cognitive impairment. The Hispanic population appears to be differentially affected by both cardiometabolic risk factors and cognitive impairment. We sought to determine whether ethnic differences in cognitive impairment in long-resident southwestern US elders was explained by the presence of cardiometabolic risk factors, and to explore patterns of cognitive decline over time. We performed a secondary analysis of data collected on 378 Hispanic and 409 non-Hispanic white adult participants in a longitudinal study of community-dwelling elderly in southern Colorado. Measures of cardiometabolic risk included waist circumference, blood pressure, diagnosis of diabetes, and random blood glucose. Cognitive measures included the Mini-Mental State Exam (MMSE) and the behavioral dyscontrol scale (a measure of executive cognitive function), at baseline and after an average of 22 months. Subjects were also administered the Center for Epidemiologic Studies Depression Scale, and the Coronary Artery Risk Development in Young Adults 1-Year Activity Recall. At baseline, Hispanic elders had a greater number of cardiometabolic risk factors and lower MMSE and behavioral dyscontrol scale scores than non-Hispanic whites. Hispanic ethnicity was associated with a greater likelihood of decline in general cognitive function, but not executive cognitive function, after adjusting for age and education. This differential decline was not explained by either individual or total number of baseline cardiometabolic risk factors, depression, or physical activity. A borderline increased risk of decline in general cognitive function was seen in sedentary individuals (P = 0.05).


Asunto(s)
Enfermedades Cardiovasculares/complicaciones , Enfermedades Cardiovasculares/psicología , Trastornos del Conocimiento/fisiopatología , Trastornos del Conocimiento/psicología , Susceptibilidad a Enfermedades/psicología , Hispánicos o Latinos/psicología , Población Blanca/psicología , Anciano , Anciano de 80 o más Años , Envejecimiento , Glucemia/análisis , Presión Sanguínea/fisiología , Enfermedades Cardiovasculares/sangre , Enfermedades Cardiovasculares/fisiopatología , Trastornos del Conocimiento/sangre , Trastornos del Conocimiento/complicaciones , Colorado/epidemiología , Depresión/sangre , Depresión/complicaciones , Depresión/fisiopatología , Depresión/psicología , Diabetes Mellitus/fisiopatología , Susceptibilidad a Enfermedades/sangre , Susceptibilidad a Enfermedades/complicaciones , Susceptibilidad a Enfermedades/fisiopatología , Función Ejecutiva , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Actividad Motora , Factores de Riesgo , Circunferencia de la Cintura/fisiología
14.
J Behav Med ; 37(3): 414-22, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23430355

RESUMEN

We evaluated whether, among persons with type 2 diabetes: (1) impaired executive cognitive functioning (ECF) is more common than among people without diabetes; (2) ECF is associated with the capacity to engage in instrumental health-related behaviors; and (3) worse ECF is associated with increased health services utilization. A population-based sample of 1,063 older people was interviewed regarding medical history and health services utilization; participants were administered the Mini Mental State Exam and the Behavioral Dyscontrol Scale, a measure of ECF. Participants with diabetes performed more poorly on cognitive measures than those without diabetes. Among those with diabetes, lower ECF was associated with more outpatient care and with ever having been in a nursing home. Impaired behavioral self-regulation may affect the capacity to engage in behaviors that could improve clinical status, resulting in greater health services use. The findings suggest the possibility of a positive feedback loop, with ECF deficits adversely affecting adherence, in turn leading to greater cognitive impairment-an issue for future research.


Asunto(s)
Trastornos del Conocimiento/etiología , Diabetes Mellitus Tipo 2/complicaciones , Función Ejecutiva/fisiología , Conductas Relacionadas con la Salud , Servicios de Salud/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Trastornos del Conocimiento/epidemiología , Colorado/epidemiología , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad
15.
Contemp Clin Trials ; 33(4): 633-40, 2012 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-22484339

RESUMEN

OBJECTIVE: The TEDDY Study is an international, multi-center prospective study designed to identify the environmental triggers of type 1 diabetes (T1D) in genetically at-risk children. This report investigates ethnic minority (EM) differences in patterns of enrollment and retention in the US centers. METHODS: As of June 2009, 267,739 newborns had been screened at birth for high risk T1D genotypes. Data collected at the time of screening, enrollment and at the baseline visit were used. Descriptive and multiple-logistic regression analyses assessed differences between EM groups regarding exclusion, enrollment and early withdrawal. RESULTS: Of the 10,975 eligible subjects, 6,912 (67%) were invited to participate. EM subjects were more likely to be excluded because of an inability to contact. Of those invited 3,265 (47%) enrolled by the age of 4.5 months. Adjusted analyses showed that except for those classified as other EM, the odds of enrolling were similar across groups. EM subjects had elevated early withdrawal rates. Adjusted models demonstrated that this was significantly more likely among Hispanic subjects. CONCLUSION: Understanding patterns associated with EM participation in research extends our ability to make more accurate inferences and permits assessment of strategies that promote inclusion of EM to better address health disparities.


Asunto(s)
Diabetes Mellitus Tipo 1/etiología , Grupos Minoritarios/estadística & datos numéricos , Pacientes Desistentes del Tratamiento/estadística & datos numéricos , Selección de Paciente , Estudios de Cohortes , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/etnología , Femenino , Disparidades en el Estado de Salud , Humanos , Lactante , Recién Nacido , Modelos Logísticos , Perdida de Seguimiento , Masculino , Tamizaje Neonatal , Estudios Prospectivos , Estados Unidos
16.
Contemp Clin Trials ; 33(2): 273-8, 2012 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-22101229

RESUMEN

OBJECTIVE: The Environmental Determinants of Diabetes in the Young (TEDDY), a multinational epidemiological study, is designed to identify environmental exposures triggering autoimmunity and type 1 diabetes (T1D) in children at increased genetic risk. The objective of this analysis was to evaluate the use of an informational video in the enrollment and retention of eligible participants at the Colorado TEDDY clinical center. STUDY DESIGN AND SETTING: Eligible participants were divided into two groups based on the inclusion of the video in the enrollment materials: the No-Video Group (n=449) did not receive the video and were contacted between 7/1/07 and 6/30/08. The Video Group (n=494) received the video and were contacted between 7/1/08 and 6/30/09. Multiple logistic regression compared the enrollment rates (percent of eligible subjects deciding to enroll) of those who received the video compared to those who did not. Kaplan-Meier survival analysis and a multivariate Cox proportional hazards model compared the differences in study retention, as defined by active participation fifteen months after the baseline visit at three months of age. RESULTS: Both groups were demographically similar. The enrollment rate was significantly higher for the Video Group (56.9%) compared to the No-Video Group (49.9%). Differences remained significant with adjustment for other known factors. A difference in retention between the two groups was not observed. CONCLUSION: Methods and materials increasing understanding and more accurately informing participants of what is involved in participation may increase enrollment in a prospective observational study.


Asunto(s)
Diabetes Mellitus Tipo 1/epidemiología , Tamizaje Masivo/métodos , Selección de Paciente , Grabación en Video/estadística & datos numéricos , Adolescente , Adulto , Femenino , Estudios de Seguimiento , Humanos , Lactante , Recién Nacido , Masculino , Observación/métodos , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Factores de Riesgo , Factores de Tiempo , Estados Unidos/epidemiología , Adulto Joven
17.
J Clin Trials ; 2(2)2012.
Artículo en Inglés | MEDLINE | ID: mdl-23894727

RESUMEN

OBJECTIVE: To assess parents' opinions about their participation in the longitudinal, multicenter study - The Environmental Determinants of Diabetes in the Young (TEDDY) consortium. METHODS: A survey was given to parents who had been in the study for ≥ 1 year. Parents rated the importance of different reasons for staying in TEDDY and how well different study components were working. Parents were also asked if they had suggestions for making TEDDY better and if they ever had thought of leaving TEDDY and if so, why. RESULTS: Out of the 3336 eligible families, 2000 completed the survey (59.1%); most (77.6%) were mothers. Survey completion was more common in European than US TEDDY sites and was associated with greater maternal education, more accurate perceptions about their child's risk of type 1 diabetes, longer participation in TEDDY and excellent attendance at TEDDY visits. "Having someone watching the child for development of T1DM" was most important reason given for staying in the study; other important reasons included "Helping science discover causes of diabetes" and "Getting child's antibody results". Most parents were very satisfied with the different components of TEDDY and had not thought of leaving the study. A minority (24%) of parents acknowledged some thoughts of leaving TEDDY and cited the blood draws, being too busy/not having enough time, the demanding protocol, and food diaries as their reasons for considering leaving. CONCLUSIONS: The study highlights factors important for successful implementation of demanding, longitudinal protocols. Friendly, devoted, skilled and knowledgeable staff with continuity makes the family comfortable. Keeping parents involved and informed on study progress is essential as is making procedures as smooth and painless as possible. Although the study is international the survey results were convergent across countries suggesting that the results have relevance to other similar studies to retain study participants.

18.
Am Heart J ; 161(5): 908-14, 2011 May.
Artículo en Inglés | MEDLINE | ID: mdl-21570521

RESUMEN

BACKGROUND: Although exercise treadmill testing (ETT) is less sensitive and specific for diagnosis of coronary disease in women, little is known about gender differences in the prognostic importance of ETT variables. METHODS: We studied 9,569 consecutive patients (46.8% women) referred for ETT between July 2001 and June 2004 in a community-based system. We assessed the association between ETT variables (exercise capacity, symptoms, ST-segment deviations, heart rate recovery, and chronotropic response) and time to all-cause death and myocardial infarction (MI), adjusting for patient and stress test characteristics. Models were stratified by gender to determine the relationship between ETT variables and outcomes. RESULTS: In the entire population, exercise capacity and heart rate recovery were significantly associated with all-cause death, whereas exercise capacity, chest pain, and ST-segment deviations were significantly associated with subsequent MI. The relationship between ETT variables and outcomes were similar between men and women, except for abnormal exercise capacity, which had a significantly stronger association with death in men (men: hazard ratio [HR] 2.89 and 95% CI 1.89-4.44, women: HR 0.99 and 95% CI 0.52-1.93, and interaction P = .01), and chronotropic incompetence, which had a significantly stronger relationship with MI in women (men: HR 1.29 and 95% CI 0.74-2.20, women: HR 2.79 and 95% CI 0.94-8.27, and interaction P = .04). CONCLUSIONS: Although many traditional ETT variables had similar prognostic value in both men and women, exercise capacity was more prognostically important in men, and chronotropic incompetence was more important in women. Future studies should confirm these findings in additional populations.


Asunto(s)
Enfermedad Coronaria/epidemiología , Electrocardiografía , Prueba de Esfuerzo/métodos , Infarto del Miocardio/epidemiología , Medición de Riesgo/métodos , Anciano , Colorado/epidemiología , Enfermedad Coronaria/complicaciones , Enfermedad Coronaria/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/fisiopatología , Estudios Retrospectivos , Factores de Riesgo , Distribución por Sexo , Factores Sexuales , Tasa de Supervivencia/tendencias
19.
J Clin Epidemiol ; 63(3): 307-14, 2010 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19716261

RESUMEN

OBJECTIVE: To assess the relationship between mortality and impairment and decline in a specific executive cognitive function, the capacity for behavioral self-regulation. STUDY DESIGN AND SETTING: This study examined the association between mortality and baseline and 22-month decline in the capacity for behavioral self-regulation, as measured by the Behavioral Dyscontrol Scale, among 1,293 participants of the San Luis Valley Health and Aging Study (SLVHAS), a population-based longitudinal study. The Behavioral Dyscontrol Scale and a measure of overall mental status, the Mini-Mental State Examination, were administered at baseline and follow-up interviews. Cox regression was used to examine baseline and decline in capacity for behavioral self-regulation as possible predictors of mortality. RESULTS: Baseline Behavioral Dyscontrol Scale score was predictive of mortality, independent of demographics and comorbidity count (hazard ratio [HR]=1.07; 95% confidence interval [CI]: 1.04, 1.09). It remained a significant predictor with further adjustment for Mini-Mental State Examination score. Decline in this specific executive cognitive function was associated with mortality after adjustment for covariates and baseline cognitive scores (HR=1.09; 95% CI: 1.04, 1.13). CONCLUSION: Thus, both baseline capacity for behavioral self-regulation and its decline over time predicted mortality in the SLVHAS cohort. These associations may partly be attributed to maintaining the ability for self-care. Understanding how specific forms of impairment contribute to mortality may help identify patients who could benefit from early intervention.


Asunto(s)
Trastornos del Conocimiento/mortalidad , Controles Informales de la Sociedad , Anciano , Anciano de 80 o más Años , Trastornos del Conocimiento/psicología , Colorado/epidemiología , Progresión de la Enfermedad , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Escalas de Valoración Psiquiátrica , Psicometría
20.
Age Ageing ; 37(5): 521-5, 2008 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-18515287

RESUMEN

Cigarette smoking is one of the leading preventable causes of death. Previous research has shown that many common smoking cessation interventions are effective with older smokers; a few interventions have been tailored to this population. To our knowledge, however, no smoking cessation research or interventions targeted at older adults have addressed the influence of cognition on successful smoking cessation. We hypothesized that impairment of executive cognitive functioning (ECF), which is relatively prevalent among older adults, would negatively influence smoking cessation rates among older smokers. The relationship of ECF to smoking cessation was examined in a population-based sample of 1,338 community-dwelling older persons in Colorado's San Luis Valley, 204 of whom were current smokers. As predicted, current ECF did not predict early smoking behaviour, but was a significant predictor of successful smoking cessation. Older persons suffering from executive dysfunction were less likely to have quit smoking than were their cognitively intact counterparts (OR = 1.10, 95% CI 1.04-1.17, P < 0.01). Among those with normal ECF, 73.7% had quit smoking, compared with 65.1% of participants showing any level of ECF impairment. Limiting the sample to individuals who were active smokers at or after the age of 65, when executive impairment is relatively common, produced similar results. Individuals with better executive functioning were more likely to have quit smoking (OR = 1.12, 95% CI 1.02-1.23, P = 0.02).


Asunto(s)
Envejecimiento , Trastornos del Conocimiento/psicología , Cognición , Cese del Hábito de Fumar/psicología , Prevención del Hábito de Fumar , Factores de Edad , Anciano , Anciano de 80 o más Años , Conducta Adictiva , Colorado/epidemiología , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Vigilancia de la Población , Escalas de Valoración Psiquiátrica , Medición de Riesgo , Fumar/efectos adversos , Fumar/epidemiología , Fumar/psicología
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