8 research outputs found
Evaluation of intussusception after oral monovalent rotavirus vaccination in South Africa
BACKGROUND: Postlicensure studies have shown an association between rotavirus vaccination and intussusception. We assessed
the risk of intussusception associated with Rotarix (RV1) administration, at 6 and 14 weeks of age, in an upper-middle-income
country, South Africa.
METHODS: Active prospective surveillance for intussusception was conducted in 8 hospitals from September 2013 through
December 2017. Retrospective case enrollment was done at 1 hospital from July 2012 through August 2013. Demographic characteristics, symptom onset, and rotavirus vaccine status were ascertained. Using the self-controlled case-series method, we estimated
age-adjusted incidence rate ratios within 1â7, 8â21, and 1â21 days of rotavirus vaccination in children aged 28â275 days at onset of
symptoms. In addition, age-matched controls were enrolled for a subset of cases (n = 169), and a secondary analysis was performed.
RESULTS: Three hundred forty-six cases were included in the case-series analysis. Postâdose 1, there were zero intussusception
cases within 1â7 days, and 5 cases within 8â21 days of vaccination. Postâdose 2, 15 cases occurred within 1â7 days, and 18 cases
within 8â21 days of vaccination. There was no increased risk of intussusception 1â7 days after dose 1 (no cases observed) or dose 2
(relative incidence [RI], 1.71 [95% confidence interval {CI} .83â3.01]). Similarly, there was no increased risk 8â21 days after the first
(RI, 4.01 [95% CI, .87â10.56]) or second dose (RI, .96 [95% CI, .52â1.60]). Results were similar for the case-control analysis.
CONCLUSIONS: The risk of intussusception in the 21 days after the first or second dose of RV1 was not higher than the background
risk among South Africa infants.Presented in part: 13th International Rotavirus Symposium, Minsk, Belarus, 29â31
August 2018.http://cid.oxfordjournals.orgpm2020Paediatrics and Child Healt
Evaluation of Intussusception After Oral Monovalent Rotavirus Vaccination in South Africa
BACKGROUND: Postlicensure studies have shown an association between rotavirus vaccination and intussusception. We assessed
the risk of intussusception associated with Rotarix (RV1) administration, at 6 and 14 weeks of age, in an upper-middle-income
country, South Africa.
METHODS: Active prospective surveillance for intussusception was conducted in 8 hospitals from September 2013 through
December 2017. Retrospective case enrollment was done at 1 hospital from July 2012 through August 2013. Demographic characteristics, symptom onset, and rotavirus vaccine status were ascertained. Using the self-controlled case-series method, we estimated
age-adjusted incidence rate ratios within 1â7, 8â21, and 1â21 days of rotavirus vaccination in children aged 28â275 days at onset of
symptoms. In addition, age-matched controls were enrolled for a subset of cases (n = 169), and a secondary analysis was performed.
RESULTS: Three hundred forty-six cases were included in the case-series analysis. Postâdose 1, there were zero intussusception
cases within 1â7 days, and 5 cases within 8â21 days of vaccination. Postâdose 2, 15 cases occurred within 1â7 days, and 18 cases
within 8â21 days of vaccination. There was no increased risk of intussusception 1â7 days after dose 1 (no cases observed) or dose 2
(relative incidence [RI], 1.71 [95% confidence interval {CI} .83â3.01]). Similarly, there was no increased risk 8â21 days after the first
(RI, 4.01 [95% CI, .87â10.56]) or second dose (RI, .96 [95% CI, .52â1.60]). Results were similar for the case-control analysis.
CONCLUSIONS: The risk of intussusception in the 21 days after the first or second dose of RV1 was not higher than the background
risk among South Africa infants.Presented in part: 13th International Rotavirus Symposium, Minsk, Belarus, 29â31
August 2018.http://cid.oxfordjournals.orgpm2020Paediatrics and Child Healt
Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study
Summary
Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally.
Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies
have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of
the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income
countries globally, and identified factors associated with mortality.
Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to
hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis,
exomphalos, anorectal malformation, and Hirschsprungâs disease. Recruitment was of consecutive patients for a
minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical
status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary
intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause,
in-hospital mortality for all conditions combined and each condition individually, stratified by country income status.
We did a complete case analysis.
Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital
diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal
malformation, and 517 with Hirschsprungâs disease) from 264 hospitals (89 in high-income countries, 166 in middleincome
countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male.
Median gestational age at birth was 38 weeks (IQR 36â39) and median bodyweight at presentation was 2·8 kg (2·3â3·3).
Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income
countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups).
Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome
countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries;
pâ€0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients
combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88â4·11],
p<0·0001; middle-income vs high-income countries, 2·11 [1·59â2·79], p<0·0001), sepsis at presentation (1·20
[1·04â1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention
(ASA 4â5 vs ASA 1â2, 1·82 [1·40â2·35], p<0·0001; ASA 3 vs ASA 1â2, 1·58, [1·30â1·92], p<0·0001]), surgical safety
checklist not used (1·39 [1·02â1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed
(ventilation 1·96, [1·41â2·71], p=0·0001; parenteral nutrition 1·35, [1·05â1·74], p=0·018). Administration of
parenteral nutrition (0·61, [0·47â0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65
[0·50â0·86], p=0·0024) or percutaneous central line (0·69 [0·48â1·00], p=0·049) were associated with lower mortality.
Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome,
middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will
be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger
than 5 years by 2030
Clinical presentation and management of childhood intussusception in South Africa
PURPOSE: We assessed management and outcomes for intussusception at nine academic hospitals in South Africa.
METHODS: Patientsâ€3 years presenting with intussusception between September 2013 and December 2017 were prospectively
enrolled at all sites. Additionally, patients presenting between July 2012 and August 2013 were retrospectively enrolled at
one site. Demographics, clinical information, diagnostic modality, reduction methods, surgical intervention and outcomes
were reviewed.
RESULTS: Four hundred seventy-six patients were enrolled, [54% males, median age 6.5 months (IQR 2.6â32.6)]. Vomiting
(92%), bloody stool (91%), abdominal mass (57%), fever (32%) and a rectal mass (29%) represented advanced disease:
median symptom duration was 3 days (IQR 1â4).
Initial reduction attempts included pneumatic reduction (66%) and upfront surgery (32%). The overall non-surgical reduction
rate was 28% and enema perforation rate was 4%. Surgery occurred in 334 (70%), 68 (20%) patients had perforated bowel,
bowel resection was required in 61%.
Complications included recurrence (2%) and nosocomial sepsis (4%). Length of stay (LOS) was signifcantly longer in
patients who developed complications. Six patients diedâa mortality rate of 1%. There was a signifcant diference in reduction rates, upfront surgery, bowel resection, LOS and mortality between centres with shorter symptom duration compared
longer symptom duration.
CONCLUSION: Delayed presentation was common and associated with low success for enema reduction, higher operative rates,
higher rates of bowel resection and increased LOS. Improved primary health-care worker education and streamlining referral
pathways might facilitate timely management.Bill and Melinda Gates Foundation (BMGF) and Fogarty International Center of the National Institutes of Health.http://link.springer.com/journal/383pm2022Paediatrics and Child Healt
Impact of the COVID-19 pandemic on patients with paediatric cancer in low-income, middle-income and high-income countries: a multicentre, international, observational cohort study
OBJECTIVES: Paediatric cancer is a leading cause of death for children. Children in low-income and middle-income countries (LMICs) were four times more likely to die than children in high-income countries (HICs). This study aimed to test the hypothesis that the COVID-19 pandemic had affected the delivery of healthcare services worldwide, and exacerbated the disparity in paediatric cancer outcomes between LMICs and HICs. DESIGN: A multicentre, international, collaborative cohort study. SETTING: 91 hospitals and cancer centres in 39 countries providing cancer treatment to paediatric patients between March and December 2020. PARTICIPANTS: Patients were included if they were under the age of 18 years, and newly diagnosed with or undergoing active cancer treatment for Acute lymphoblastic leukaemia, non-Hodgkin's lymphoma, Hodgkin lymphoma, Wilms' tumour, sarcoma, retinoblastoma, gliomas, medulloblastomas or neuroblastomas, in keeping with the WHO Global Initiative for Childhood Cancer. MAIN OUTCOME MEASURE: All-cause mortality at 30 days and 90 days. RESULTS: 1660 patients were recruited. 219 children had changes to their treatment due to the pandemic. Patients in LMICs were primarily affected (n=182/219, 83.1%). Relative to patients with paediatric cancer in HICs, patients with paediatric cancer in LMICs had 12.1 (95% CI 2.93 to 50.3) and 7.9 (95% CI 3.2 to 19.7) times the odds of death at 30 days and 90 days, respectively, after presentation during the COVID-19 pandemic (p<0.001). After adjusting for confounders, patients with paediatric cancer in LMICs had 15.6 (95% CI 3.7 to 65.8) times the odds of death at 30 days (p<0.001). CONCLUSIONS: The COVID-19 pandemic has affected paediatric oncology service provision. It has disproportionately affected patients in LMICs, highlighting and compounding existing disparities in healthcare systems globally that need addressing urgently. However, many patients with paediatric cancer continued to receive their normal standard of care. This speaks to the adaptability and resilience of healthcare systems and healthcare workers globally
Twelve-month observational study of children with cancer in 41 countries during the COVID-19 pandemic
Childhood cancer is a leading cause of death. It is unclear whether the COVID-19 pandemic has impacted childhood cancer mortality. In this study, we aimed to establish all-cause mortality rates for childhood cancers during the COVID-19 pandemic and determine the factors associated with mortality
Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries
Background
Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks.
Methods
The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned.
Results
A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31).
Conclusion
Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)