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Universal newborn hearing screening (UNHS) facilitates early detection of permanent congenital hearing loss in newborns. In recognition of specific needs among parents, support services have been established within some UNHS programs, including the Victorian Infant Hearing Screening Program (VIHSP). Despite this, there is limited research about how to best support parents in the context of well-established UNHS programs. This project aims to retrospectively explore parental support needs between the newborn hearing screen and enrolment into early intervention services. We used semi-structured interviews with parents three- to- six-months post confirmation of their newborn's diagnosis of bilateral moderate-profound sensorineural hearing loss. Data were analysed using inductive content analysis. Thirteen parents of ten children were interviewed. Parents described high satisfaction with the support they received. Some parents felt unprepared for a diagnosis of hearing loss, having been reassured that transient causes such as middle ear fluid caused the hearing screen result. Parents reported mixed responses regarding the value of parent-mentor support along the pathway and some parents described needing additional psychological input to adjust to their child's diagnosis. These findings provide insights into how a well-established UNHS program, VIHSP, supports parents along the hearing diagnosis pathway and how support can be further enriched.
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BACKGROUND: Optimal mental health is critical for a child's learning and academic functioning. As a universal service, early education centres play an important role in promoting children's mental health. Social-emotional learning programs are efficacious in reducing behavioural difficulties, enhancing competence, and improving learning abilities. Mindfulness practices, known to promote health and wellbeing in adults, have been adapted to education programs for younger populations, including pre-school children. Despite an increasing use of mindfulness-based programs in pre-school settings, there is a limited number of randomised trials and paucity of data on implementation fidelity of these programs. 'Early Minds' is a mindfulness-based program developed by Smiling Mind for 3-5-year-old children. This paper describes a protocol of a pilot randomised control trial, evaluating the implementation of the program in early learning centres (ELCs, i.e. pre-schools) in Melbourne, Australia. The primary aim of this pilot study is to examine the feasibility, acceptability, and fidelity of the program. The secondary aims are to assess the acceptability of the design and measures and to investigate preliminary impacts of the program on child social-emotional outcomes. METHODS: A convenience sample of six ELCs are recruited. Participants include educators, children, and their parents from 3- and/or 4-year-old ELC rooms. Upon completion of baseline surveys, rooms are randomly allocated to intervention and control arms by an independent statistician. 'Early Minds' is designed in a flexible delivery manner; meditations and activities are completed at least three times a week. Educators are trained in the program and have access to the activities and meditations on an app. Parents are encouraged to practice with their children at least three times a week. Educators document implementation fidelity throughout the 8 weeks of the program. Parents and educators complete follow-up surveys at 3 and 12 months post-randomisation, capturing feasibility and acceptability, child social-emotional behaviour and sleep, and educator, parent, and family wellbeing outcomes. DISCUSSION: This pilot study is the first to assess a mindfulness-based program in ELCs in Australia. Data on feasibility and acceptability, implementation fidelity, and potential impact on children's behaviour will inform the design of adequately powered evaluation trials. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry, ACTRN12618000435280. Date registered 26 March 2018.
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AIMS: To investigate the causal associations between family relationships, family functioning, social circumstances and health outcomes in young children with cystic fibrosis. BACKGROUND: The anticipated health gains for patients with cystic fibrosis, promised by early diagnosis through newborn screening, have yet to be fully realized, despite advances in cystic fibrosis health care with aggressive management in multidisciplinary clinics and the development of specific medications. Adverse psychosocial functioning may underpin the current lack of progress as it is well recognized that compromised early parent-child attachment relationship experiences and adverse social circumstances have negative impacts on lifelong health status and health resource use, even in healthy children. DESIGN: A cross-sectional (initial) and longitudinal (progressive), multicentre study of children aged 3 months-6 years with cystic fibrosis, who have been diagnosed by newborn screening. METHODS: Questionnaire and observational measures of parent psychosocial functioning, parenting and parent-child attachment and social markers; and including clinical outcomes of regular health surveillance with clinical, lung imaging (computerized tomography) and bronchoalveolar lavage for airway microbiology and inflammation. CONCLUSION: This will be the first study to investigate the causal effect of psychosocial functioning, parenting and attachment on physical health outcome measures in children with cystic fibrosis.
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Fibrosis Quística/fisiopatología , Estado de Salud , Niño , Preescolar , Humanos , LactanteRESUMEN
BACKGROUND: In children with cystic fibrosis (CF) sleep, eating/mealtime, physiotherapy adherence and internalising problems are common. Caregivers also often report elevated depression, anxiety and stress symptoms. PURPOSE: To identify, through principal components analysis (PCA), coping strategies used by Australian caregivers of children with CF and to assess the relationship between the derived coping components, caregiver mental health symptoms and child treatment related and non-treatment related problem behaviours. METHOD: One hundred and two caregivers of children aged 3 to 8 years from three CF clinic sites in Australia, completed self-report questionnaires about their coping and mental health and reported on their child's sleep, eating/mealtime, treatment adherence and internalising and externalising behaviours. RESULTS: Two caregiver coping components were derived from the PCA: labelled 'proactive' and 'avoidant' coping. 'Avoidant' coping correlated moderately with caregiver depression (0.52), anxiety (0.57) and stress (0.55). For each unit increase in caregiver use of avoidant coping strategies, the odds of frequent child eating/mealtime behaviour problems increased by 1.3 (adjusted 95 % CI 1.0 to 1.6, p = .03) as did the odds of children experiencing borderline/clinical internalising behaviour problems (adjusted 95 % CI 1.1 to 1.7, p = .01). Proactive coping strategies were not associated with reduced odds of any child problem behaviours. CONCLUSIONS: Avoidant coping strategies correlated with caregiver mental health and child problem behaviours. Intervening with caregiver coping may be a way to improve both caregiver mental health and child problem behaviours in pre-school and early school age children with CF.
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Adaptación Psicológica , Cuidadores/psicología , Fibrosis Quística/psicología , Depresión/psicología , Salud Mental , Ansiedad/psicología , Australia , Niño , Preescolar , Estudios Transversales , Fibrosis Quística/enfermería , Femenino , Humanos , Masculino , Comidas/psicología , Trastornos Mentales/psicología , Análisis de Componente Principal/métodos , Encuestas y CuestionariosRESUMEN
BACKGROUND: In cystic fibrosis (CF), problems with sleep, eating/mealtime behaviours, physiotherapy adherence and parental mental health issues are common, yet their natural history and the extent of service use to address them are unknown. OBJECTIVE: Follow up the 2007 cohort to determine: (1) prevalence of child sleep, eating/mealtime behaviours, physiotherapy adherence, and externalising/internalising problem behaviours and primary caregiver mental health status after a 3-year period; (2) natural history of child behaviours; (3) potentially modifiable predictors of persistent problems; and (4) service use for behaviours. DESIGN: Prospective cohort. SETTING: Royal Children's Hospital, Monash Medical Centre and Sydney Children's Hospital (Australia) CF clinics. PARTICIPANTS: Caregivers, of children aged 3-8 years, who completed the baseline questionnaire. MAIN OUTCOME MEASURES: Child sleep, eating/mealtime behaviours, adherence with therapy and externalising and internalising behaviours. PREDICTORS: parenting style (low warmth), caregiver mental health status and sleep quality at baseline. RESULTS: 102 of 116 (88%) families participated. The prevalence of sleep and eating/mealtime problems at follow-up was similar to baseline. The prevalence of caregiver mental health symptoms remained higher than the community data. 71 out of 102 (70%) of the children experienced at least one persistent behaviour problem. Caregiver mental health difficulties predicted persistent child moderate to severe sleep problems (adjusted OR 6.5, 95% CI 1.2 to 36.2, p=0.03) and their persistently poor adherence to the physiotherapy regimen (adjusted OR 3.5, 95% CI 1.3 to 9.2, p=0.01). CONCLUSIONS: Child problem behaviours are common in children with CF, persist and are often predicted by the mental health of the parent. Routine surveillance for and management of child problem behaviours are recommended.
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Trastornos de la Conducta Infantil/etiología , Fibrosis Quística/psicología , Cuidadores/psicología , Niño , Trastornos de la Conducta Infantil/diagnóstico , Trastornos de la Conducta Infantil/epidemiología , Hijo de Padres Discapacitados/psicología , Preescolar , Fibrosis Quística/epidemiología , Fibrosis Quística/rehabilitación , Trastornos de Ingestión y Alimentación en la Niñez/epidemiología , Trastornos de Ingestión y Alimentación en la Niñez/etiología , Femenino , Servicios de Salud/estadística & datos numéricos , Humanos , Control Interno-Externo , Masculino , Trastornos Mentales/psicología , Nueva Gales del Sur/epidemiología , Relaciones Padres-Hijo , Padres/psicología , Cooperación del Paciente/psicología , Modalidades de Fisioterapia/psicología , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Trastornos del Sueño-Vigilia/epidemiología , Trastornos del Sueño-Vigilia/etiología , Victoria/epidemiologíaRESUMEN
OBJECTIVE: To determine the benefits of a low intensity parent-toddler language promotion programme delivered to toddlers identified as slow to talk on screening in universal services. DESIGN: Cluster randomised trial nested in a population based survey. SETTING: Three local government areas in Melbourne, Australia. PARTICIPANTS: Parents attending 12 month well child checks over a six month period completed a baseline questionnaire. At 18 months, children at or below the 20th centile on an expressive vocabulary checklist entered the trial. INTERVENTION: Maternal and child health centres (clusters) were randomly allocated to intervention (modified "You Make the Difference" programme over six weekly sessions) or control ("usual care") arms. MAIN OUTCOME MEASURES: The primary outcome was expressive language (Preschool Language Scale-4) at 2 and 3 years; secondary outcomes were receptive language at 2 and 3 years, vocabulary checklist raw score at 2 and 3 years, Expressive Vocabulary Test at 3 years, and Child Behavior Checklist/1.5-5 raw score at 2 and 3 years. RESULTS: 1217 parents completed the baseline survey; 1138 (93.5%) completed the 18 month checklist, when 301 (26.4%) children had vocabulary scores at or below the 20th centile and were randomised (158 intervention, 143 control). 115 (73%) intervention parents attended at least one session (mean 4.5 sessions), and most reported high satisfaction with the programme. Interim outcomes at age 2 years were similar in the two groups. Similarly, at age 3 years, adjusted mean differences (intervention-control) were -2.4 (95% confidence interval -6.2 to 1.4; P=0.21) for expressive language; -0.3 (-4.2 to 3.7; P=0.90) for receptive language; 4.1 (-2.3 to 10.6; P=0.21) for vocabulary checklist; -0.5 (-4.4 to 3.4; P=0.80) for Expressive Vocabulary Test; -0.1 (-1.6 to 1.4; P=0.86) for externalising behaviour problems; and -0.1 (-1.3 to 1.2; P=0. 92) for internalising behaviour problems. CONCLUSION: This community based programme targeting slow to talk toddlers was feasible and acceptable, but little evidence was found that it improved language or behaviour either immediately or at age 3 years. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20953675.
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Trastornos del Desarrollo del Lenguaje/terapia , Desarrollo del Lenguaje , Terapia del Lenguaje/normas , Vocabulario , Servicios de Salud del Niño , Preescolar , Análisis por Conglomerados , Estudios de Factibilidad , Femenino , Humanos , Lactante , Masculino , Servicios de Salud Materna , Encuestas y Cuestionarios , Resultado del Tratamiento , VictoriaRESUMEN
OBJECTIVE: Studies in Western populations have shown the association of nonsteroidal anti-inflammatory drugs (NSAIDs) and upper gastrointestinal bleeding (UGIB). The role of Helicobacter pylori infection in NSAIDs-related UGIB remains to be studied. We conducted a case-control study in Japan to investigate these related topics. METHODS: Cases of UGIB due to duodenal or gastric ulcer, or gastritis were identified in 14 study hospitals in various areas of Japan. For each case, two controls were identified from population registries in the same district. Information on drugs and other risk factors was obtained from 175 cases and 347 controls by telephone interviews. Anti-H. pylori antibody in the urine was measured in a single laboratory for all the cases and 225 controls. RESULTS: The odds ratio (OR) of UGIB was 5.5 for aspirin and 6.1 for other NSAIDs (NANSAIDs) (p<0.01). The OR for regular use was higher than for occasional use both for aspirin (7.7 vs 2.0) and NANSAIDs (7.3 vs 4.1). Loxoprofen (5.9), frequently used in Japan as a safe 'prodrug', was significantly associated with UGIB. The odds ratio for H. pylori infection was 4.9 and the relative excess risk due to the interaction between H. pylori and the use of NSAID was 1.2 (95% CI: -5.8-8.1). CONCLUSION: NSAIDs including loxoprofen increase the risk of UGIB in Japan as in Western countries, with a similar magnitude of association. There was no evidence of biological interaction between NSAIDs and H. pylori infection.
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Antiinflamatorios no Esteroideos/efectos adversos , Hemorragia Gastrointestinal/inducido químicamente , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Femenino , Infecciones por Helicobacter/complicaciones , Helicobacter pylori , Humanos , Masculino , Persona de Mediana Edad , Oportunidad RelativaRESUMEN
AIM: To ascertain the extent to which general practitioners (GPs) routinely weigh, measure and calculate body mass index (BMI) in children, and to assess the accuracy and accessibility of their anthropometric equipment. METHODS: A convenience sample of 34 GPs from 29 primary care family medical practices in Melbourne, Australia, completed a questionnaire regarding their routine anthropometric practice for 5-10-year-old children and perceived role in managing childhood overweight and obesity. Practice audits (April-June 2002) assessed the accuracy and accessibility of anthropometric equipment. RESULTS: Forty-four per cent of GPs reported regularly weighing children; 38% regularly measured children's height. Only one regularly calculated children's BMI. Formal training in child anthropometry and servicing of anthropometric equipment was rare. The majority of equipment was accessible. Stadiometers on average measured the height of a 'short' pole (true height 92.68 cm) as 92.52 cm (SD = 0.8), and measured the height of a 'tall' pole (true height 157.64 cm) as 157.55 cm (SD = 0.9). On average, calibration weights of 20 kg and 80 kg were recorded as 19.7 kg (SD = 0.6) and 79.2 kg (SD = 1.5) respectively. Despite these shortcomings, these GPs generally felt they played a key role in managing overweight in children. CONCLUSIONS: Self-reported practice by these GPs falls well short of 2003 National Health and Medical Research Council guidelines recommending bi-annual measuring of all children in the primary care setting. The variability of anthropometric equipment audited could result in widely discrepant BMI values, leading to serious misclassification of many children's weight status.
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Antropometría/instrumentación , Equipo para Diagnóstico/normas , Medicina Familiar y Comunitaria/instrumentación , Obesidad/diagnóstico , Pautas de la Práctica en Medicina , Adulto , Antropometría/métodos , Índice de Masa Corporal , Niño , Desarrollo Infantil/fisiología , Preescolar , Medicina Familiar y Comunitaria/educación , Medicina Familiar y Comunitaria/normas , Femenino , Humanos , Masculino , Auditoría Médica , Persona de Mediana Edad , Obesidad/prevención & control , Sobrepeso/fisiología , Guías de Práctica Clínica como Asunto , Encuestas y Cuestionarios , VictoriaRESUMEN
BACKGROUND: Concerns have been raised that more infants with Goldenhar syndrome were born to U.S. Gulf War veterans than expected. Goldenhar syndrome is considered a variant of the malformation hemifacial microsomia (HFM). We used data collected from a case-control study of HFM to estimate risk in relation to parental military service and, in particular, Gulf War service. METHODS: Cases with HFM who were three years old or younger were identified at craniofacial clinics in 24 U.S. cities and matched to controls by age and pediatrician. The mothers of 232 cases and 832 controls were interviewed between April 1996 and November 2002 about pregnancy events and exposures, including military service before the child was born and Gulf War deployment five to 11 years before the child was born. Odds ratios were adjusted for family income, race, and body mass index in early pregnancy. RESULTS: Four (1.7%) case mothers and 10 (1.2%) control mothers served in the military. Among fathers, 30 (12.9%) cases and 100 (12.0%) controls served in the military. The parents of four (1.7%) cases and 23 (2.8%) controls served in the Gulf War (multivariate adjusted odds ratio [MVOR], 0.8; 95% confidence interval [CI], 0.3-2.3). All four case parents with Gulf War service were in the Army compared to 9 of 23 control parents. The MVOR for parental Gulf War service in the Army was 2.8 (95% CI, 0.8-9.6). The corresponding MVOR for any parental service in the Army was 2.4 (95% CI, 1.4-4.2), based on 22 cases and 45 controls. CONCLUSIONS: The risk of HFM in offspring was not associated with parental service in the Gulf War five to 11 years before birth. The odds ratio for service in the Army was independent of Gulf War service and was associated with a modest increase in risk. Our findings for service in the Army may be confounded by unmeasured lifestyle factors.
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Asimetría Facial , Guerra del Golfo , Veteranos , Estudios de Casos y Controles , Asimetría Facial/etiología , Femenino , Humanos , Masculino , Oportunidad Relativa , Factores de RiesgoRESUMEN
OBJECTIVE: To identify demographic and reproductive risk factors for hemifacial microsomia in offspring. DESIGN: In a case-control study, maternal interviews were conducted within 3 years after delivery. Cases with hemifacial microsomia were ascertained from craniofacial centers in 26 cities in the United States and Canada. Controls were patients of the cases' pediatricians. Two hundred thirty-nine cases were compared with 854 controls. Odds ratios for various infant and maternal factors were estimated. RESULTS: Cases had lower birth weights, were more often male or a twin, and had more relatives with craniofacial malformations or hearing loss than controls. Case mothers had lower family incomes, had a lower body mass index, had more vaginal bleeding in the second trimester, and were more likely to have had a spontaneous abortion in a previous pregnancy. CONCLUSIONS: Nonmodifiable factors (age and parity) were not associated with hemifacial microsomia risk. Factors that are related to poverty (low family income, late recognition of pregnancy, and low body mass index) are associated with an increase in risk. High risk estimates for multiple pregnancies and second-trimester vaginal bleeding suggest a vascular etiology.
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Asimetría Facial/congénito , Asimetría Facial/epidemiología , Estudios de Casos y Controles , Preescolar , Anomalías Craneofaciales/complicaciones , Enfermedades en Gemelos/epidemiología , Asimetría Facial/complicaciones , Salud de la Familia , Femenino , Humanos , Lactante , Recién Nacido de Bajo Peso , Recién Nacido , Masculino , Oportunidad Relativa , Embarazo , Complicaciones Cardiovasculares del Embarazo , Resultado del Embarazo , Efectos Tardíos de la Exposición Prenatal , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Factores Socioeconómicos , Hemorragia UterinaRESUMEN
BACKGROUND: Based on experimental evidence and clinical observations, hemifacial microsomia (HFM) is one of several structural anomalies that are postulated to result from vascular disruption. We collected data in a case-control study to identify whether vasoactive exposures or vascular events during early pregnancy affect the risk of HFM. METHODS: Cases with a diagnosis of HFM were identified at craniofacial centers in 26 cities across the United States and Canada, from 1996 to 2002. Controls were matched to cases by age and pediatrician practice. Mothers of 230 cases and 678 controls were interviewed about pregnancy events and exposures. Case and control mothers were compared for early pregnancy use of vasoactive medications, cigarettes, and alcohol; singleton or multiple gestation; and diabetes, hypertension, or vaginal bleeding in the first half of pregnancy. RESULTS: Odds ratios (ORs) were significantly increased for vasoactive mediation use (OR, 1.9 overall; OR, 4.2 among smokers), multiple gestations (OR, 10.5), and diabetes (OR, 6.0). Vaginal bleeding in the second trimester and heavy alcohol intake were associated with increased risks, but the estimates were based on small numbers and, therefore, are unstable. No associations were observed for cigarette smoking without vasoactive medication use, hypertension, and vaginal bleeding in the first trimester. CONCLUSIONS: The increased risks of HFM associated with vasoactive medication use, multiple gestations, diabetes, and second trimester vaginal bleeding appear collectively to support the hypothesis that vascular disruption is one etiology for HFM, because each of these factors is related to effects on blood vessels.
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Asimetría Facial/congénito , Asimetría Facial/epidemiología , Enfermedades Vasculares/etiología , Consumo de Bebidas Alcohólicas/efectos adversos , Canadá/epidemiología , Estudios de Casos y Controles , Preescolar , Intervalos de Confianza , Asimetría Facial/complicaciones , Asimetría Facial/diagnóstico , Femenino , Humanos , Lactante , Recién Nacido , Entrevistas como Asunto , Oportunidad Relativa , Embarazo , Complicaciones Cardiovasculares del Embarazo/epidemiología , Resultado del Embarazo , Primer Trimestre del Embarazo , Segundo Trimestre del Embarazo , Embarazo Múltiple , Efectos Tardíos de la Exposición Prenatal , Estudios Retrospectivos , Riesgo , Factores de Riesgo , Fumar/efectos adversos , Estados Unidos/epidemiología , Enfermedades Vasculares/epidemiologíaRESUMEN
BACKGROUND: Gastroschisis and small intestinal atresia are congenital anomalies that may arise from vascular disruption. It is hypothesized that maternal exposure to cocaine, amphetamines, decongestants and nicotine, all of which have vasoconstrictive actions, can contribute to these defects. The present study examined risks of gastroschisis and small intestinal atresia associated with combined exposure to vasoconstrictive drugs and cigarette smoking. METHODS: This was a retrospective study conducted from 1995 to 1999 in 15 cities across the United States and Canada. Mothers of 205 gastroschisis cases, 127 small intestinal atresia cases, 381 malformed controls and 416 nonmalformed controls were interviewed within 6 months of delivery. RESULTS: Reported vasoconstrictive drugs included pseudoephedrine, phenylpropanolamine, ephedrine and methylenedioxymethamphetamine. Combined exposure to vasoconstrictive drugs and cigarette smoking in the first 2.5 months of pregnancy was reported by 9% of gastroschisis cases, 9% of small intestinal atresia cases and 4% of controls. Multivariate-adjusted odds ratios, controlling for the effects of age, education, income, other drug use and alcohol intake, were 2.1 (95% confidence interval = 1.0-4.4) for gastroschisis and 2.8 (1.1-6.9) for small intestinal atresia. Risks of each defect increased with increasing level of cigarettes (P for trend = 0.019 and 0.012, respectively). Vasoconstrictive drug use among smokers of 20 or more cigarettes a day increased gastroschisis risk 3.6-fold (1.3-10.3) and small intestinal atresia risk 4.2-fold (1.1-16.2). CONCLUSIONS: These findings provide further evidence of vascular disruption as an etiology for gastroschisis and small intestinal atresia.
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Gastrosquisis/epidemiología , Atresia Intestinal/epidemiología , Intestino Delgado/anomalías , Complicaciones del Embarazo , Fumar/efectos adversos , Vasoconstrictores/efectos adversos , Adulto , Estudios de Casos y Controles , Femenino , Gastrosquisis/etiología , Humanos , Recién Nacido , Atresia Intestinal/etiología , Análisis Multivariante , Embarazo , Estudios Retrospectivos , Factores de Riesgo , VasoconstricciónRESUMEN
Gastroschisis and small intestinal atresia (SIA) are birth defects that are thought to arise from vascular disruption of fetal mesenteric vessels. Previous studies of gastroschisis have suggested that risk is increased for maternal use of vasoactive over-the-counter medications, including specific analgesics and decongestants. This retrospective study evaluated the relation between maternal use of cough/cold/analgesic medications and risks of gastroschisis and SIA. From 1995 to 1999, the mothers of 206 gastroschisis cases, 126 SIA cases, and 798 controls in the United States and Canada were interviewed about medication use and illnesses. Risks of gastroschisis were elevated for use of aspirin (odds ratio = 2.7, 95% confidence interval: 1.2, 5.9), pseudoephedrine (odds ratio = 1.8, 95% confidence interval: 1.0, 3.2), acetaminophen (odds ratio = 1.5, 95% confidence interval: 1.1, 2.2), and pseudoephedrine combined with acetaminophen (odds ratio = 4.2, 95% confidence interval: 1.9, 9.2). Risks of SIA were increased for any use of pseudoephedrine (odds ratio = 2.0, 95% confidence interval: 1.0, 4.0) and for use of pseudoephedrine in combination with acetaminophen (odds ratio = 3.0, 95% confidence interval: 1.1, 8.0). Reported fever, upper respiratory infection, and allergy were not associated with risks of either defect. These findings add more evidence that aspirin use in early pregnancy increases risk of gastroschisis. Although pseudoephedrine has previously been shown to increase gastroschisis risk, findings of this study raise questions about interactions between medications and possible confounding by underlying illness.