Background
The SARS‐CoV‐19 pandemic and its associated lockdowns affected children's lifestyle dramatically. The effect of such changes on children's weight and obesity status is unknown. The aim of ...this study was to compare body weight and obesity rates in children from before the pandemic to 6 months after the major periods of lockdowns in Israel.
Methods
We used data from medical records of pediatric emergency department visits, where weight is routinely measured, to compare weight and obesity prevalence in the fourth quartile of 2020 (n = 2468) as compared with the fourth quartiles of 2018–2019 (n = 5300). Weight was transformed to age‐ and sex‐specific standard‐deviation‐scores (SDS) for analysis.
Results
Weight‐SDS increased by a mean of 0.07 during the first 6 months of the pandemic, yet this was only significant in preschoolers. Obesity rates also increased in this age group only, by 37%, from 8.1% to 11.1% (p = 0.01).
Conclusions
Weight‐SDS and obesity prevalence increased during the SARS‐CoV‐19 pandemic, yet only in younger children. Additional studies from other populations are needed.
Aim
We aimed to evaluate the risk of developing adolescent scoliosis among recipients of recombinant human growth hormone (rhGH).
Methods
This registry‐based cohort study included 1314 individuals ...who initiated rhGH treatment since 2013, treated during 10–18 years of age for at least 6 months. This group was matched to a comparison group of 6570 individuals not treated with rhGH. Demographic and clinical information was extracted from the electronic database. The results are presented using hazard ratios (HR) and 95% confidence intervals (CI).
Results
During a median follow‐up of 4.2 years, 59 (4.5%) rhGH recipients and 141 individuals (2.1%) from the comparison group were diagnosed with adolescent scoliosis. The age at diagnosis did not differ between the groups (14.7 versus 14.3 years, p = 0.095). Patients treated with rhGH were more likely diagnosed with scoliosis (HR 2.12, 95% CI 1.55–2.88, p < 0.001). Among males, the risk was about three times greater in the treated versus the comparison group (HR 3.15, 95% CI 2.12–4.68, p < 0.001), while in females the risk was not increased (HR 1.12, 95% CI 0.72–2.04, p = 0.469).
Conclusions
Recombinant human growth hormone treatment was associated with an increased risk to be diagnosed with adolescent scoliosis in males. Scoliosis development should be monitored appropriately in rhGH recipients.
Summary
Background
Paediatric Crohn's disease is characteried by frequently relapsing disease which may lead to hospitalisations and complications.
Aim
To develop predictive models for early relapse ...following first remission.
Methods
The GROWTH CD prospective inception cohort was designed to predict risk for early disease relapse and poor outcomes. Newly diagnosed children underwent endoscopies and imaging. They were phenotyped and followed at scheduled visits through 78 weeks for relapses. Twenty‐eight dichotomous and continuous variables were assessed at baseline and week 12, including phenotype, inflammatory markers, disease activity (PCDAI) and other markers. Clinical relapses defined as PCDAI >10 after remission were recorded using a relapse form. Logistic regression & risk modelling was performed.
Results
We enrolled 282 eligible patients of whom 178 (63.6%) patients achieved steroid free remission by week 12. Disease complications developed in 22/76(29%) of patients with relapse compared to 20/206 (9.7%) without relapse (P = 0.01). Multivariable analysis demonstrated that while variables from age/gender at diagnosis were not predictive, week 12 variables including PCDAI >5 (P = 0.02), CRP >20 mg/L (P = 0.02), and faecal calprotectin >400 µg/g (P = 0.03) as optimal cut‐offs were associated with increased risk of relapse. A prediction model for patients in remission including gender, age, week 12 PCDAI, calprotectin and CRP had sensitivity 43%, specificity 92%, PPV 78%, NPV 71% for relapse.
Conclusions
Early relapses were associated with a higher risk for disease complications at followup. Relapse prediction based on week 12 disease activity or inflammation is superior to prediction using data from diagnosis.
Objectives
Patients with relapsed/refractory AL amyloidosis (RRAL) have poor prognosis, but emerging data shows promising results with the use daratumumab. We evaluated daratumumab treatment in RRAL ...in real‐world setting.
Methods
A retrospective multisite study of RRAL patients treated with daratumumab alone and in combinations.
Results
Forty‐nine patients, diagnosed between 1.1.2008 and 1.2.2018 were included; 27% also had multiple myeloma (MM). Revised Mayo score was ≥ 3 in 67%. Hematologic overall response rate was 81%, 64% achieved very good partial response (VGPR) or better. Concurrent active MM was associated with lower rates of VGPR (OR 0.19, 95% CI 0.04‐0.81; P = .03) in a multi‐variate analysis. Cardiac and renal responses were 74% and 73%, respectively. Median progression‐free survival (PFS) was 28.4 months and median overall survival (OS) was not reached; 2‐year PFS and OS were 68.6 ± 7.5% and 90.4 ± 4.6%, respectively. Hematologic response correlated with prolonged PFS and OS. Daratumumab was safe and well tolerated, no patients discontinued therapy due to toxicity. Our data was aligned with outcomes from a systematic literature review, which identified 10 case series (n = 517) and 2 clinical trials (n = 62) meeting prespecified criteria.
Conclusions
Our data support favorable safety tolerability and efficacy of daratumumab among non‐selective RRAL patients in a real‐world setting.
Exclusive enteral nutrition (EEN) is recommended for children with mild to moderate Crohn’s disease (CD), but implementation is challenging. We compared EEN with the CD exclusion diet (CDED), a ...whole-food diet coupled with partial enteral nutrition (PEN), designed to reduce exposure to dietary components that have adverse effects on the microbiome and intestinal barrier.
We performed a 12-week prospective trial of children with mild to moderate CD. The children were randomly assigned to a group that received CDED plus 50% of calories from formula (Modulen, Nestlé) for 6 weeks (stage 1) followed by CDED with 25% PEN from weeks 7 to 12 (stage 2) (n = 40, group 1) or a group that received EEN for 6 weeks followed by a free diet with 25% PEN from weeks 7 to 12 (n = 38, group 2). Patients were evaluated at baseline and weeks 3, 6, and 12 and laboratory tests were performed; 16S ribosomal RNA gene (V4V5) sequencing was performed on stool samples. The primary endpoint was dietary tolerance. Secondary endpoints were intention to treat (ITT) remission at week 6 (pediatric CD activity index score below 10) and corticosteroid-free ITT sustained remission at week 12.
Four patients withdrew from the study because of intolerance by 48 hours, 74 patients (mean age 14.2 ± 2.7 years) were included for remission analysis. The combination of CDED and PEN was tolerated in 39 children (97.5%), whereas EEN was tolerated by 28 children (73.6%) (P = .002; odds ratio for tolerance of CDED and PEN, 13.92; 95% confidence interval CI 1.68–115.14). At week 6, 30 (75%) of 40 children given CDED plus PEN were in corticosteroid-free remission vs 20 (59%) of 34 children given EEN (P = .38). At week 12, 28 (75.6%) of 37 children given CDED plus PEN were in corticosteroid-free remission compared with 14 (45.1%) of 31 children given EEN and then PEN (P = .01; odds ratio for remission in children given CDED and PEN, 3.77; CI 1.34–10.59). In children given CDED plus PEN, corticosteroid-free remission was associated with sustained reductions in inflammation (based on serum level of C-reactive protein and fecal level of calprotectin) and fecal Proteobacteria.
CDED plus PEN was better tolerated than EEN in children with mild to moderate CD. Both diets were effective in inducing remission by week 6. The combination CDED plus PEN induced sustained remission in a significantly higher proportion of patients than EEN, and produced changes in the fecal microbiome associated with remission. These data support use of CDED plus PEN to induce remission in children with CD. Clinicaltrials.gov no: NCT01728870.
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Background. Fecal microbial transplantation (FMT) is the delivery of fecal microbiome, isolated from healthy donors, into a patient’s gastrointestinal tract. FMT is a safe and efficient treatment for ...recurrent Clostridioides difficile infection. Donors undergo strict screening to avoid disease transmission. This consists of several blood and stool tests, which are performed in a multistage, costly process. We performed a cost-minimizing analysis to find the optimal order in which the tests should be performed. Methods. An algorithm to optimize the order of tests in terms of cost was defined. Performance analysis for disqualifying a potential healthy donor was carried out on data sets based on either the published literature or our real-life data. For both data sets, we calculated the total cost to qualify a single donor according to the optimal order of tests, suggested by the algorithm. Results. Applying the algorithm to the published literature revealed potential savings of 94.2% of the cost of screening a potential donor and 7.05% of the cost to qualify a single donor. In our cohort of 87 volunteers, 53 were not eligible for donation. Of 34 potential donors, 10 were disqualified due to abnormal lab tests. Applying our algorithm to optimize the order of tests, the average cost for screening a potential donor resulted in potential savings of 49.9% and a 21.3% savings in the cost to qualify a single donor. Conclusions. Improving the order and timing of the screening tests of potential FMT stool donors can decrease the costs by about 50% per subject.
Highlights
What is known:
Fecal microbial transplantation (FMT) is the transfer of microbiome from healthy donors to patients.
Fecal donors undergo multiple strict screening tests to exclude any transmissible disease.
Screening tests of potential fecal donors is expensive and time consuming.
FMT is the most efficient treatment for recurrent C difficile infection.
What is new here:
An algorithm to optimize the order of donors’ screening tests in terms of cost was defined.
Optimizing the order tests can save nearly 50% in costs of screening a potential donor.
Current knowledge regarding chronic use of psychotropic medications during breastfeeding is limited. The objective of this study was to evaluate the long-term effects of psychotropic monotherapy use ...during lactation on the breastfed infant.
In this prospective study, we followed 280 infants whose mothers contacted the Drug Consultation Center (DCC) at Assaf Harofeh Medical Center between January 2011 and December 2015, seeking information regarding the chronic use of psychotropic medications during lactation. This group was compared with a group of 152 callers, who inquired evidence regarding the use of antibiotics compatible with breastfeeding. Information on adverse effects, physical measures and gross motor developmental milestone achievements of the breastfed infants was obtained during a follow-up telephone interview. At follow up, the median age of the infants in the Psychotropic-drug group was 20 (11-33) months versus 36 (20-48) months in the Antibiotic group (p < 0.001). The outcomes were compared between the groups followed by a propensity score matching to control for difference in baseline characteristics.
At follow-up, no significant differences between infants in the two groups were observed with regard to height, weight, head circumference and weight-length ratio percentile (p = 0.339, p = 0.223, p = 0.738, p = 0.926, respectively). Children in both groups were, according to their parents, within the normal developmental range for all milestones, according to the Denver Developmental Scale. Use of psychotropic medications during breastfeeding was not significantly associated with adverse reactions. After propensity score matching (n = 120 pairs) to control for differences in baseline characteristics and the length of lactation, only one significant difference was reported, sleepiness in infants in the study group (7/120) and none in the comparison group (p = 0.008).
Chronic use of psychotropic monotherapy during lactation is associated with normal growth and gross motor developmental as by milestone achievements reported by parents. Sleepiness was reported, it seemed self-limited with no developmental effect.
Abstract
Aims
Tricuspid regurgitation (TR) is a frequent echocardiographic finding; however, its effect on outcome is unclear. The objectives of current study were to evaluate the impact of TR ...severity on heart failure hospitalization and mortality.
Methods and results
We retrospectively reviewed consecutive echocardiograms performed between 2011 and 2016 at the Tel-Aviv Medical Center. TR severity was determined using semi-quantitative approach including colour jet area, vena contracta width, density of continuous Doppler jet, hepatic vein flow pattern, trans-tricuspid inflow pattern, annular diameter, right ventricle, and right atrial size. Major comorbidities, re-admissions and all-cause mortality were extracted from the electronic health records. The final analysis included 33 305 patients with median follow-up period of 3.34 years (interquartile range 2.11–4.54). TR (≥mild) was present in 31% of our cohort. One-year mortality rates were 7.7% for patients with no/trivial TR, 16.8% for patients with mild TR, 29.5% for moderate TR, and 45.6% for patients with severe TR (P < 0.001). Univariate and multivariate analyses demonstrated a positive correlation between TR severity and overall mortality and rates of heart failure re-admission after adjustment for potential confounders. The proportional hazards method for overall mortality showed that patients with moderate hazard ratio (HR) 1.15, 95% confidence interval (CI) 1.02–1.3, P = 0.024 and severe TR (HR 1.43, 95% CI 1.08–1.88, P = 0.011) had a worse prognosis than those with no or minimal TR.
Conclusions
The presence of any degree of TR is associated with adverse clinical outcome. At least moderate TR is independently associated with increased mortality.
Background:
The association between intraductal papillary mucinous neoplasms (IPMNs) and colorectal cancer (CRC) and polyps is controversial.
Objectives:
To compare the prevalence of CRC and ...colorectal polyps among patients with IPMN and matched average risk individuals.
Methods:
A match cross-sectional historical study comparing colonoscopy findings of 310 patients with IPMN cysts who underwent at least one colonoscopy examination from 2004 through 2019, with 310 age- and gender-matched average risk participants who underwent a screening colonoscopy. CRC and polyps were assessed in both groups. The prevalence and odds ratio were calculated.
Results:
CRC was diagnosed in 16 of 310 patients with IPMN (5.2%), and at least one polyp was detected in 96 patients (31%). The prevalence of CRC was greater among patients with IPMN than in matched individuals 5.2% versus 1.3%, p = 0.012, prevalence odds ratio (POR) 4, confidence interval (CI) 1.29–16.44. The overall prevalence of polyps was not higher among patients with IPMN than in matched individuals (31% versus 26.8%, p = 0.291, POR 1.22, CI 0.85–1.76). However, the prevalence of colorectal adenomas with high-grade dysplasia was higher in patients with IPMN than in matched individuals (4.2% versus 1%, p = 0.02, POR 4.33, CI, 1.19–23.7). The prevalence of large polyps (i.e. more than 20 mm in size) was also greater in patients with IPMN than in matched individuals (6.1% versus 1.9%, p = 0.011, POR 3.6, CI, 1.29–12.40).
Conclusion:
Patients with IPMN have a significantly higher prevalence of CRC and advanced polyps than the average risk population. In view of our findings, we suggest that once the diagnosis of IPMN is made, special consideration of CRC should be undertaken.
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