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AIM: As herpes simplex virus (HSV) in infancy is not a mandatory notifiable condition in Australia, completeness of ascertainment by the Australian Paediatric Surveillance Unit (APSU) has been difficult to evaluate to date. We evaluated case capture in Queensland (QLD) and Western Australia (WA) using statewide laboratory and clinical data and complementary surveillance data collected via the APSU. METHODS: HSV polymerase chain reaction positive results in infants (0-3 months) from 2007 to 2017 were obtained from statewide public pathology providers in QLD and WA. Clinical data were extracted from patient records and compared to APSU reported cases. RESULTS: A total of 94 cases of HSV disease in infancy (70 QLD; 24 WA) were identified from laboratory data sets, compared to 36 cases (26 QLD; 10 WA) reported to the APSU. In total there was 102 unique cases identified; 28 cases were common to both data sets (seven skin eye mouth (SEM) disease, 13 central nervous system (CNS) disease and eight disseminated disease). Active surveillance captured 35% (36/102) of cases overall including 74% (14/19) of CNS, 71% (10/14) of disseminated and 17% (12/69) of SEM disease cases, respectively. Surveillance reported cases had a higher case-fatality rate compared to those not reported (14% vs. 3%, P = 0.038). Neurological sequelae at discharge were comparable between the groups. CONCLUSION: Active surveillance captures one third of hospitalised HSV cases in QLD and WA, including the majority with severe disease. However, morbidity and mortality remain high. Future studies on HSV will rely on observational studies. Enhanced case ascertainment through combined laboratory and surveillance data is essential for better understanding and improving outcomes.
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The Australian Paediatric Surveillance Unit (APSU), established in 1993 to address the paucity of national data on rare childhood disorders, has become an invaluable research resource. It facilitates prospective, active surveillance for a variety of rare disorders, with monthly reporting by ~1500 paediatricians, who are invited to notify incident cases and provide demographic and clinical data. APSU is highly collaborative (used by >400 individuals/organisations), patient-informed and productive (>300 publications). In 30 years, 72 studies have been initiated on rare infections, and genetic, psychological and neurological disorders, and injuries. Return rates of monthly report cards were >90% for 30 years and paediatricians have provided data for >90% of notified cases. Although there are limitations, including case underascertainment in remote regions, APSU often provides the only available national data. APSU has assisted the government in reporting to the WHO, developing national strategies, informing inquiries and investigating disease outbreaks. APSU data have informed paediatrician education, practice, policy, and service development and delivery. APSU was integral in establishing the International Network of Paediatric Surveillance Units (INoPSU) and supporting development of other units. APSU's expanded remit includes one-off surveys, hospital audits, systematic reviews, studies on the impacts of rare disorders on families, surveillance evaluations, and joint studies with INoPSU members. Paediatricians value the APSU, reporting that APSU data inform their practice. They must be congratulated for an outstanding collective commitment to the APSU, in providing unique data that contribute to our understanding of rare disorders and support optimal, evidence-based care and improved child health outcomes.
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The text within this report, as originally published, incorrectly stated that the two included cases of dengue had not recently travelled to a dengue-endemic country. A reexamination of the case data has shown that both cases had recently travelled to a country where dengue is endemic. The paragraph below provides the corrected text for the dengue case descriptions, and replaces the paragraph at the foot of the right-hand column of text on page 10 of the published report. In 2022, two cases of dengue were notified to the APSU, one confirmed and one probable (Table 1), and the incidence estimate for the surveillance period (1 February - 31 December 2022) is shown in Table 2. Neither child had a prior history of dengue; however, both had recently travelled to an endemic country. One had DENV2 serotype and the serotype was not recorded for the second child. Both children were hospitalised and symptoms included fever, rash, cough, severe abdominal pain, diarrhoea, fatigue, retro-orbital pain and myalgia/arthralagia joint pains. One child had respiratory co-infection with human metapneumovirus. Both children received supportive therapies (intravenous fluids, pain relief) and one child received ceftriaxone. On discharge, one child had ongoing problems including arthralgia, fatigue, thrombocytopaenia and hepatitis.
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For 30 years the Australian Paediatric Surveillance Unit (APSU) has conducted national surveillance of rare communicable diseases and rare complications of communicable diseases. In this report, we describe the results of thirteen such studies surveyed by the APSU in 2022, including reported case numbers and incidence estimates, demographics, clinical features, management and short-term outcomes. Conditions described are: acute flaccid paralysis (AFP); congenital cytomegalovirus (cCMV); neonatal and infant herpes simplex virus (HSV) infection; perinatal exposure to human immunodeficiency virus (HIV) and paediatric HIV infection; severe complications of influenza; juvenile-onset recurrent respiratory papillomatosis (JoRRP); congenital rubella infection/syndrome; congenital varicella syndrome (CVS) and neonatal varicella infection (NVI); and the new conditions dengue; Q fever; and severe acute hepatitis. In 2022, cases of severe complications of influenza were reported to the APSU for the first time since 2019. This likely reflects the easing of government-mandated restrictions imposed in 2020-2021 to curb the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the re-emergence of a range of infectious diseases. As previously, AFP surveillance by the APSU contributed to Australia achieving a minimum target incidence of one AFP case per 105 children aged less than 15 years. Cases of JoRRP and NVI were reported in 2022. This indicates potential gaps in human papillomavirus (HPV) and varicella vaccination coverage respectively, especially in high-risk groups such as young migrant and refugee women of childbearing age from countries without universal vaccination programs. Paediatric HIV case numbers resulting from mother-to-child-transmission (MTCT) of HIV remain low in Australia due to use of effective intervention strategies. However, there has been an increase in the number of imported cases of HIV in children (mainly perinatally-acquired) from countries with a high HIV prevalence. Without effective vaccines, there has been no decline in the incidence of congenital CMV and neonatal HSV, indicating the importance of early identification and management to reduce morbidity and mortality. The first cases of dengue, Q fever and severe acute hepatitis were received by APSU in 2022, including two cases of acute hepatitis in which aetiology has not been confirmed to date. The APSU has an important ongoing role in monitoring rare childhood infections.
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Varicela , Enfermedades Transmisibles , Infecciones por Citomegalovirus , Dengue , Infecciones por VIH , Hepatitis , Gripe Humana , Fiebre Q , Síndrome de Rubéola Congénita , Lactante , Recién Nacido , Embarazo , Humanos , Femenino , Niño , Infecciones por VIH/epidemiología , Varicela/epidemiología , Varicela/prevención & control , Gripe Humana/epidemiología , alfa-Fetoproteínas , Australia/epidemiología , Transmisión Vertical de Enfermedad Infecciosa , Enfermedades Transmisibles/epidemiologíaRESUMEN
BACKGROUND: X-linked hypophosphataemia (XLH) is the most common heritable form of rickets. Prevalence data varies across the literature between 1 in 20,000 and 1 in 200,000 per population. METHODS: Australian and New Zealand Paediatric Surveillance Units collected cross-sectional data from paediatricians on existing cases to estimate prevalence and characteristics of paediatric XLH in Australia and New Zealand. RESULTS: Seventy-five cases in Australia and 18 cases in New Zealand were identified. Estimated minimum prevalence based on these cases was 1.33 (1.04-1.66) per 100,000 and 1.60 per 100,000 (95%CI 0.97-2.58) in Australia and New Zealand respectively, with actual prevalence likely higher due to incomplete ascertainment. Despite a family history in most cases, delayed diagnosis was common, with 49 % diagnosed after 2 years of age. Delayed diagnosis was more common in sporadic versus familial cases. Most common clinical characteristics included leg bowing (89 %), bone and joint pain (68 %), abnormal gait (57 %) and short stature (49 %). There was a significant burden of orthopaedic disease and surgeries and a high rate of complications of nephrocalcinosis and hyperparathyroidism (32 % and 20 % respectively). Additionally, while guidelines stress the importance of multidisciplinary care, many did not have access to recommended health professionals, with only 3 % seeing a psychologist and 68 % seeing a dentist. This is despite the high psychological burden of XLH and a significant proportion (41 %) of this cohort having dental issues (tooth abscess, dental capping, tooth extraction). There were two cases from NZ without data available. Of the 91 cases with data collected, 46 % were on burosumab therapy. Consistent with clinical trials, those on burosumab had a higher serum phosphate levels (p < 0.001) at most recent follow-up. Three cases reported cancellation of orthopaedic surgery due to improvement in lower limb deformity after commencement of burosumab. CONCLUSION: These data describe the multisystem burden of disease for children with XLH with care impacted by delayed diagnosis and a lack of access to many health professionals, especially psychological support.
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Raquitismo Hipofosfatémico Familiar , Niño , Humanos , Australia/epidemiología , Estudios Transversales , Raquitismo Hipofosfatémico Familiar/epidemiología , Raquitismo Hipofosfatémico Familiar/tratamiento farmacológico , Nueva Zelanda/epidemiología , PrevalenciaRESUMEN
To compare the incidence and outcomes of congenital and neonatal varicella in Australia in the pre-vaccination (1995-1997) and post-vaccination era (after 2005 to November 2020), active prospective national surveillance for congenital varicella syndrome (CVS) and neonatal varicella infection (NVI) was conducted through the Australian Paediatric Surveillance Unit (APSU). Compared with 1995-1997, there was a 91.5% reduction in the incidence of CVS and a 91.3% reduction in the incidence of NVI in 2009-2020. However, almost half of the mothers in 2009-2020 were born overseas and came from countries without a vaccination program. Although there has been a substantial and sustained decrease in the reported incidence of CVS and NVI in Australia since 2006, congenital and neonatal varicella infections persist. Thus, there is an opportunity for targeted screening of varicella in young migrant, asylum seeker and refugee women at risk of varicella infection and prioritisation for vaccination to prevent CVS and NVI.
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INTRODUCTION: Acute flaccid paralysis (AFP) surveillance continues globally as part of the World Health Organization's goal to eradicate poliomyelitis. The Australian Paediatric Surveillance Unit (APSU), Paediatric Active Enhanced Disease Surveillance (PAEDS) network, and National Enterovirus Reference Laboratory (NERL) collaborate in AFP surveillance in Australia, capturing and reviewing cases of AFP for all aetiologies in order to exclude poliovirus. We aimed to describe the AFP epidemiology in childhood over an 11 year period. METHODS: Data were reported nationally by paediatricians via prospective APSU surveillance, PAEDS surveillance nurses at five tertiary paediatric hospitals and NERL from 2007 to 2017. Children aged 0-15 years with AFP were included. We combined APSU, PAEDS, and NERL datasets, analysed epidemiological trends, and described clinical features and investigations for major diagnoses. RESULTS: Of 590 AFP-compatible cases, 49% were male; 47% were aged 0-4 years, 9% aged <1 year. Annual incidence of AFP was 1.3 cases per 100,000 children aged <15 years. Lower limb paralysis was the most frequent presenting symptom. The most frequent diagnoses were Guillain-Barre syndrome (GBS; 36%), transverse myelitis (TM; 17%), and acute disseminated encephalomyelitis (ADEM; 15%). No secular trend was seen in frequency of AFP cases nor amongst major diagnoses. Seasonality was observed with ADEM occurring more frequently in winter. We observed periods of increased AFP frequency in 2013 and 2016, coinciding with increased reporting of non-polio anterior horn cell disease (AHCD) and detection of non-polio enterovirus (NPEV). CONCLUSIONS: Estimated incidence of GBS, ADEM, and TM in Australian children was comparable with international rates. There was stable incidence of AFP in Australian children between 2007 and 2017. GBS, ADEM, and TM are the major causes of AFP. We observed clustering of cases associated with NPEV that emphasises a need for ongoing vigilance in surveillance given continue emerging infectious disease threats.
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Poliomielitis , alfa-Fetoproteínas , Niño , Humanos , Masculino , Lactante , Femenino , Estudios Prospectivos , Australia/epidemiología , Parálisis/epidemiología , Parálisis/diagnóstico , Parálisis/etiología , Poliomielitis/complicaciones , Poliomielitis/epidemiología , Vigilancia de la PoblaciónRESUMEN
Abstract: The Australian Paediatric Surveillance Unit (APSU) has been conducting surveillance of rare communicable and non-communicable conditions in children since its inception in 1993. In this report, the results are described of surveillance of ten communicable diseases (and complications) for 2021, including the numbers of cases and incidence estimates; demographics; clinical features; and management and short-term outcomes. The included diseases are: acute flaccid paralysis (AFP); congenital cytomegalovirus (CMV); neonatal herpes simplex virus (HSV) infection; paediatric human immunodeficiency virus (HIV) infection; perinatal exposure to HIV; severe complications from influenza; juvenile-onset respiratory papillomatosis (JoRRP); congenital rubella syndrome; congenital varicella syndrome; and neonatal varicella infection. In 2021, cases of JoRRP were reported to the APSU for the first time since 2017, indicating potential gaps in HPV vaccination. AFP surveillance by APSU again contributed to Australia achieving a minimum target incidence of one AFP case per 100,000 children aged < 15 years. There were no cases of children with severe complications of influenza. No cases of varicella or congenital rubella were reported; however, at-risk populations, especially young migrant and refugee women from countries without universal vaccination programs, need to be screened and prioritised for vaccination prior to pregnancy. Cases of perinatal exposure to HIV continue to increase; however, the rate of mother-to-child-transmission remains at low levels due to the use of effective intervention strategies. Case numbers of congenital CMV and neonatal HSV remain steady in the absence of vaccines, prompting the need for greater awareness and education, with recent calls for target screening of at-risk infants for congenital CMV.
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Varicela , Enfermedades Transmisibles , Infecciones por Citomegalovirus , Infecciones por VIH , Gripe Humana , Síndrome de Rubéola Congénita , Femenino , Humanos , Lactante , Recién Nacido , Embarazo , Australia/epidemiología , Varicela/epidemiología , Varicela/prevención & control , Enfermedades Transmisibles/epidemiología , Infecciones por VIH/epidemiología , Transmisión Vertical de Enfermedad Infecciosa , Gripe Humana/epidemiologíaRESUMEN
OBJECTIVE: The aim of this study was to collect prospective national data on early-onset eating disorders (EOEDs) in children in Australia to document changes in clinical presentations, medical complications, management, and incidence since initially described in 2002-2005. METHOD: Each month pediatricians reported children aged 5-13 years newly diagnosed with an eating disorder to the Australian Paediatric Surveillance Unit and provided de-identified clinical data. RESULTS: Between 2016 and 2018, 184 children were confirmed with EOED with a minimum estimated national incidence of 2.79 per 100,000 children aged 5-13 years (95% confidence interval [CI] 2.40-3.23), nearly double the previously recorded incidence. The mean age at diagnosis was 12.2 years; 43(24%) were boys who were younger than girls (11.85 vs. 12.33 years; p = .03). All had food avoidance. Common symptoms included fear of weight gain 140 (76%), preoccupation with body weight 134 (73%), and misperception of body size 116 (63%). Bradycardia was present in 83 (45%) and 117 (64%) who required hospital admission. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5) criteria for anorexia nervosa were met for 144 (78%). DISCUSSION: Children with eating disorders continue to present with severe illness. Near doubling in incidence in just over a 10-year period highlights the need for increased clinical resourcing and comparable international data. PUBLIC SIGNIFICANCE: The incidence of new presentations of eating disorders in children aged 5-13 years has nearly doubled since a similar study was conducted over 10 years ago. Children were unwell for an average of 8 months before diagnosis; approximately 80% had a clear diagnosis of anorexia nervosa and 64% needed hospital admission due to medical complications. This highlights the need for improvements in education and clinical resources for this age group.
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Trastornos de Alimentación y de la Ingestión de Alimentos , Aumento de Peso , Niño , Humanos , Estudios Prospectivos , Australia/epidemiología , Trastornos de Alimentación y de la Ingestión de Alimentos/diagnóstico , Trastornos de Alimentación y de la Ingestión de Alimentos/epidemiologíaRESUMEN
OBJECTIVES & METHODS: CINtec PLUS and cobas HPV tests were compared for triaging patients referred to colposcopy with a history of LSIL cytology in a 2-year prospective study. Cervical specimens were tested once at enrollment, and test positivity rates determined. Test performance was ascertained with cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3 or worse (CIN3+) serving as clinical endpoints. RESULTS: In all ages, (19-76 years, n= 598), 44.3% tested CINtec PLUS positive vs. 55.4% HPV positive (p< 0.001). To detect CIN2+ (n= 99), CINtec PLUS was 81.8% sensitive vs. 93.9% for HPV testing (p= 0.009); genotype 16/18-specific sensitivity was 46.5%. Specificity was 52.9% vs. 36.6%, respectively (p< 0.001). In all ages, to detect CIN3+ (n= 44), sensitivity was 93.2% for both tests; genotype 16/18-specific sensitivity was 52.3%. Specificity was 48.4% for CINtec PLUS vs. 31.1% for HPV testing (p< 0.001). In patients < 30 years, CINtec was 91.7% sensitive vs 95.8% for HPV testing (p= 0.549). CONCLUSIONS: CINtec PLUS or cobas HPV test could serve as a predictor of CIN3+ with high sensitivity in patients referred to colposcopy with a history of LSIL regardless of age while significantly reducing the number of LSIL referral patients requiring further investigations and follow-up in colposcopy clinics.
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Infecciones por Papillomavirus , Displasia del Cuello del Útero , Neoplasias del Cuello Uterino , Adulto , Anciano , Canadá , Colposcopía , Inhibidor p16 de la Quinasa Dependiente de Ciclina , Detección Precoz del Cáncer , Femenino , Humanos , Antígeno Ki-67 , Persona de Mediana Edad , Papillomaviridae/genética , Embarazo , Estudios Prospectivos , Derivación y Consulta , Sensibilidad y Especificidad , Neoplasias del Cuello Uterino/diagnóstico , Adulto Joven , Displasia del Cuello del Útero/genéticaRESUMEN
Since 2012, the United States has reported a distinct syndrome of acute flaccid paralysis (AFP) with anterior myelitis, predominantly in children. This polio-like syndrome was termed acute flaccid myelitis (AFM). Australia routinely conducts AFP surveillance to exclude poliomyelitis. We reviewed 915 AFP cases in Australia for children <15 years of age during 2000â2018 and reclassified a subset to AFM by using the US Council of State and Territorial Epidemiologists case definition. We confirmed 37 AFM cases by using magnetic resonance imaging findings and 4 probable AFM cases on the basis of cerebrospinal fluid pleocytosis. Nonpolio enteroviruses were detected in 33% of AFM cases from which stool samples were tested. Average annual AFM incidence was 0.07 cases/100,000 person-years in children <15 years of age. AFM occurred sporadically in Australia before 2010 but regularly since then, indicating sustained, albeit rare, clinical manifestation in children. The AFP surveillance system in Australia is well-positioned to identify future AFM cases.
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Enfermedades Virales del Sistema Nervioso Central , Infecciones por Enterovirus , Mielitis , Enfermedades Neuromusculares , Adolescente , Australia/epidemiología , Enfermedades Virales del Sistema Nervioso Central/diagnóstico , Enfermedades Virales del Sistema Nervioso Central/epidemiología , Niño , Preescolar , Infecciones por Enterovirus/diagnóstico , Infecciones por Enterovirus/epidemiología , Humanos , Lactante , Mielitis/diagnóstico , Mielitis/epidemiología , Enfermedades Neuromusculares/diagnóstico , Enfermedades Neuromusculares/epidemiología , Parálisis/diagnóstico , Parálisis/epidemiologíaRESUMEN
AIM: To describe clinical characteristics, outcomes and causes of microcephaly in children whose condition was identified within the first year of life. METHODS: Retrospective review of medical records of microcephalic children born between 2008 and 2018 and admitted for any reason during the same period to a tertiary paediatric hospital. Microcephaly was defined as occipitofrontal circumference (OFC) more than two standard deviations below the mean (>-2 SD). RESULTS: Between January 2008 and September 2018, 1083 medical records were retrieved. Of the children, 886 were ineligible and 197 were confirmed cases of microcephaly. Of cases, 73 (37%) had primary microcephaly (at birth) and 72 (37%) had severe microcephaly (OFC > -3 SD). Of microcephalic children, 192 (98%) had congenital anomalies, of whom 93% had major anomalies, mostly cardiovascular or musculoskeletal. Neurological signs or symptoms were reported in 148 (75%), seizures being the most common. Of the 139 children with abnormal central nervous system (CNS) imaging, one or more structural brain abnormalities were identified in 124 (89%). Failure to reach developmental milestones was observed in 69%, visual impairment in 41% and cerebral palsy in 13%. Microcephaly was idiopathic in 51% and 24% had diagnosed genetic disorders. There was no association between developmental outcomes or structural brain anomalies and severity of microcephaly or timing of diagnosis. CONCLUSION: Our results suggest the need for a systematic investigative approach to diagnosis, including a careful history, examination, genetic testing and neuroimaging, to determine the underlying cause of microcephaly, identify co-morbidities, predict prognosis and guide genetic counselling and therapy.
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Microcefalia , Malformaciones del Sistema Nervioso , Australia/epidemiología , Niño , Humanos , Lactante , Recién Nacido , Microcefalia/complicaciones , Microcefalia/diagnóstico , Microcefalia/epidemiología , Neuroimagen/métodos , Estudios RetrospectivosRESUMEN
Sudden unexpected death in infancy (SUDI) requires a thorough process of inquiry including a detailed history, death scene investigation and autopsy by appropriate and informed health professionals to identify aetiology. Paediatricians are required to conduct the medical, social and family history as well as provide support to the family for the approximately 45 deaths each year in New South Wales (NSW). The aim of this study is describe paediatricians' experience in conducting SUDI assessments with reference to current NSW Health policy and identify barriers to its implementation. METHODS: Paediatricians in NSW who participate in the Australian Paediatric Surveillance Unit (APSU) were invited to complete a questionnaire requesting information about their knowledge and confidence in managing an infant presenting with SUDI, awareness and use of the NSW Health Policy Directive, and their own recommendations for management. A second questionnaire was completed by paediatricians who had attended a SUDI in the previous five years. RESULTS: The first survey was completed by 234/524 (44%) NSW paediatricians. Half the respondents (118/234) were aware of the SUDI Policy Directive and of those 72/118 (61%) had read it. Few paediatricians (63/234) 27% had received education on the Policy Directive or about SUDI management 55/234 (24%). The second survey was completed by 33/36 (92%) who had attended a SUDI, of whom 29% had not used the history protocol within the Policy Directive. CONCLUSION: Lack of awareness, perceived problems with the current Policy, and limited confidence suggests the model in NSW needs revision to meet international recommendations for best management and diagnosis and also supportive and preventive practices for parents.
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Muerte Súbita del Lactante , Australia , Autopsia , Niño , Humanos , Lactante , Padres , Pediatras , Muerte Súbita del Lactante/epidemiologíaRESUMEN
ABSTRACT: For 27 years, national prospective data on selected rare childhood diseases have been collected monthly by the Australian Paediatric Surveillance Unit (APSU) from paediatricians and other clinical specialists who report cases in children aged up to 16 years. We report here the annual results of APSU surveillance in 2020 for ten rare communicable diseases and complications of communicable diseases, namely: acute flaccid paralysis (AFP); congenital cytomegalovirus (CMV) infection; neonatal herpes simplex virus (HSV) infection; perinatal exposure to human immunodeficiency virus (HIV); paediatric HIV infection; severe complications of seasonal influenza; juvenile onset recurrent respiratory papillomatosis (JoRRP); congenital rubella syndrome; congenital varicella syndrome; and neonatal varicella infection. We describe the results for each disease in the context of the total period of study, including demographics, clinical characteristics, treatment and short-term outcomes. Despite challenges presented by the coronavirus disease 2019 (COVID-19) pandemic in 2020, more than 1,400 paediatricians reported regularly to the APSU and an overall monthly reporting rate of > 90% was achieved. The minimum AFP target of 1 case per 100,000 children aged less than 15 years was achieved and there were few cases of vaccine-preventable diseases (JoRRP, rubella, varicella). However, high cases of congenital CMV, neonatal HSV and perinatal exposure to HIV persist. There were no severe complications of seasonal influenza reported for the first time in 13 years. This is consistent with other surveillance data reporting a decline of influenza and other communicable diseases in 2020, and likely reflects the wider effects of public health measures to reduce transmission of SARS-CoV-2 in the Australian community.
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COVID-19 , Infecciones por VIH , Australia/epidemiología , Niño , Femenino , Humanos , Recién Nacido , Embarazo , Estudios Prospectivos , SARS-CoV-2RESUMEN
BACKGROUND: Systemic Therapies for HER2-Positive Metastatic Breast Cancer Study (SystHERs, NCT01615068) was a prospective, observational disease registry designed to identify treatment patterns and clinical outcomes in patients with HER2-positive metastatic breast cancer (MBC) in real-world treatment settings. METHODS: SystHERs enrolled patients aged ≥ 18 years with recently diagnosed HER2-positive MBC. Treatment regimens and clinical management were determined by the treating physician. In this analysis, patients were compared descriptively by first-line treatment, age, or race. Multivariate logistic regression was used to examine the associations between baseline variables and treatment selections. Clinical outcomes were assessed in patients treated with trastuzumab (Herceptin [H]) + pertuzumab (Perjeta [P]). RESULTS: Patients were enrolled from June 2012 to June 2016. As of February 22, 2018, 948 patients from 135 US treatment sites had received first-line treatment, including HP (n = 711), H without P (n = 175), or no H (n = 62) (with or without chemotherapy and/or hormonal therapy). Overall, 68.7% received HP + taxane and 9.3% received H without P + taxane. Patients aged < 50 years received HP (versus H without P) more commonly than those ≥ 70 years (odds ratio 4.20; 95% CI, 1.62-10.89). Chemotherapy was less common in patients ≥ 70 years (68.2%) versus those < 50 years (88.0%) or 50-69 years (87.4%). Patients treated with HP had median overall survival of 53.8 months and median progression-free survival of 15.8 months. CONCLUSIONS: Our analysis of real-world data shows that most patients with HER2-positive MBC received first-line treatment with HP + taxane. However, older patients were less likely to receive dual HER2-targeted therapy and chemotherapy.
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Neoplasias de la Mama , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias de la Mama/tratamiento farmacológico , Femenino , Humanos , Estudios Prospectivos , Receptor ErbB-2 , Sistema de Registros , Trastuzumab/uso terapéutico , Resultado del TratamientoRESUMEN
OBJECTIVE: To describe infants aged <12 months reported with microcephaly to the Australian Paediatric Surveillance Unit (APSU) following emergence of Zika virus infection internationally. DESIGN, SETTING AND PATIENTS: National, active, monthly surveillance for microcephaly using the APSU. Microcephaly was defined as occipitofrontal circumference (OFC) of more than 2 SDs below the mean for age, gender and gestation. MAIN OUTCOME MEASURES: Clinical spectrum, aetiology and birth prevalence of microcephaly reported by paediatricians. RESULTS: Between June 2016 and July 2018, 106 notifications were received, with clinical details provided for 96 (91%). After excluding ineligible notifications, 70 cases were confirmed, giving an annual birth prevalence of 1.12 (95% CI 0.88 to 1.42) per 10 000 live births. Of the total number of cases, 47 (67%) had primary microcephaly (at birth); and 25 (36%) had severe microcephaly (OFC >3 SDs). Birth defects were reported in 42 (60%). Of 49 infants with developmental assessment details available, 25 (51%) had failed to reach all milestones. Vision impairment was reported in 14 (26%). The cause of microcephaly was unknown in 60%: 13 (19%) had been diagnosed with genetic disorders; 22 (39%) had anomalies on neuroimaging. No congenital or probable Zika infection was identified. Severe microcephaly was more often associated with hearing impairment than microcephaly of >2 SDs but ≤3 SDs below the mean (p<0.007). Indigenous children and children with socioeconomic advantage were over-represented among children with microcephaly. CONCLUSION: Novel national data on microcephaly highlight the high proportion of idiopathic cases. This has implications for prevention and management and suggests the need for a standardised diagnostic approach and ongoing surveillance mechanism in Australia.
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Microcefalia/diagnóstico , Microcefalia/epidemiología , Vigilancia en Salud Pública/métodos , Infección por el Virus Zika/epidemiología , Adulto , Australia/epidemiología , Anomalías Congénitas/epidemiología , Discapacidades del Desarrollo/epidemiología , Femenino , Genotipo , Humanos , Lactante , Recién Nacido , Masculino , Microcefalia/etiología , Microcefalia/genética , Neuroimagen/métodos , Embarazo , Complicaciones Infecciosas del Embarazo/epidemiología , Prevalencia , Índice de Severidad de la Enfermedad , Trastornos de la Visión/epidemiología , Virus Zika/aislamiento & purificación , Infección por el Virus Zika/virologíaRESUMEN
OBJECTIVE AND METHODS: CINtec PLUS and cobas HPV tests were assessed for triaging women referred to colposcopy with a history of LSIL cytology. Both tests were performed at baseline using ThinPrep cervical specimens and biopsy confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) served as the clinical endpoint. RESULTS: In all ages, (19-76 years, n = 600), 44.3% (266/600) tested CINtec PLUS positive vs. 55.2% (331/600) HPV positive (p = 0.000). Based on 224 having biopsies, sensitivity to detect CIN2+ (n = 54) was 81.5% (44/54) for CINtec PLUS vs. 94.4% (51/54) for HPV testing (p = 0.039); specificities were, 52.4% (89/170) vs. 44.1% (75/170), respectively (p = 0.129). In women ≥30 years (n = 386), 41.2% (159/386) tested CINtec PLUS positive vs. 50.8% (196/386) HPV positive (p = 0.008). Based on 135 having biopsies, sensitivity to detect CIN2+ (n = 24) was 95.8% (23/24) for both CINtec PLUS and HPV tests; specificities were, 55.0% (61/111) vs. 50.5% (56/111), respectively (p = 0.503). CONCLUSIONS: For women referred to colposcopy with a history of LSIL cytology, CINtec PLUS or cobas HPV test could serve as a predictor of CIN2+ with high sensitivity, particularly in women ≥30 years. Either test can significantly reduce the number of women requiring further investigations and follow up in colposcopy clinics.
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Técnicas de Diagnóstico Molecular/normas , Papillomaviridae/genética , Infecciones por Papillomavirus/diagnóstico , Juego de Reactivos para Diagnóstico/normas , Lesiones Intraepiteliales Escamosas/diagnóstico , Adulto , Anciano , Cuello del Útero/patología , Cuello del Útero/virología , Colposcopía/estadística & datos numéricos , ADN Viral/genética , Femenino , Humanos , Persona de Mediana Edad , Técnicas de Diagnóstico Molecular/estadística & datos numéricos , Ontario , Infecciones por Papillomavirus/virología , Estudios Prospectivos , Juego de Reactivos para Diagnóstico/estadística & datos numéricos , Sensibilidad y Especificidad , Lesiones Intraepiteliales Escamosas/patología , Lesiones Intraepiteliales Escamosas/virología , Neoplasias del Cuello Uterino/virología , Adulto Joven , Displasia del Cuello del Útero/diagnóstico , Displasia del Cuello del Útero/virologíaRESUMEN
The Australian Paediatric Surveillance Unit (APSU) has been prospectively collecting national data on rare childhood conditions since 1993, with monthly reporting of cases by paediatricians. In this report we describe annual results from studies for ten communicable diseases and complications of communicable diseases that were conducted using APSU surveillance in 2019 and place these in an historic context. Results are reported on acute flaccid paralysis, congenital cytomegalovirus infection, neonatal herpes simplex virus infection, perinatal exposure to HIV, paediatric HIV infection, severe complications of seasonal influenza, juvenile onset recurrent respiratory papillomatosis (JoRRP), congenital rubella syndrome, congenital varicella syndrome and neonatal varicella infection. APSU provides rich clinical data to complement data collected from other surveillance systems and to improve understanding and response to rare childhood infections.