scholarly journals Trainee involvement increases precut rates and delays access to the common bile duct without an increase in procedure-related adverse events: a brave new world of ERCP training?

2018 ◽  
Vol 56 (1) ◽  
pp. 55-61 ◽  
Author(s):  
Theodor Voiosu ◽  
Andrei Voiosu ◽  
Andreea Benguş ◽  
Mihai Rimbaş ◽  
Bogdan Mateescu

Abstract Background and aims. Selective cannulation of the desired duct is a key element in ERCP procedures and an important step in the training of fellows. However, there is limited data about technical success and patient safety for ERCPs conducted in a training setting.We aimed to evaluate the impact of trainee involvement on the cannulation technique and procedure related outcomes at ERCP. Materials and methods. We conducted an observational study of all ERCP conducted in an endoscopy unit with an on-going training program. Patient related data and procedure-related data (method of cannulation, time to cannulation, degree of trainee involvement, technical success and procedure-related adverse events) were collected using a standard form. The method of cannulation, time to cannulation and procedure-related adverse events were compared between ERCPs with trainee involvement and those without. Results. 641 consecutive ERCPs were evaluated and 474 native papilla cases performed by 4 trainers and 3 trainees were included in the final analysis. Trainees were involved in 171 procedures (36.1%), achieving cannulation of the desired duct in 50.8% of the cases. Cannulation rates were similar in the trainee group compared to the control group (91.7% vs. 88.7%) and there was no increase in the rate of adverse events. However, cannulation time was significantly longer in the trainee group with a significant increase in the rate of precut use (32.1% vs. 23.4%, p < 0.001). Conclusions. Trainee involvement resulted in longer cannulation times and increased use of precut sphincterotomy, but, was not associated with an increased risk of procedure related adverse events.

Endoscopy ◽  
2019 ◽  
Vol 52 (02) ◽  
pp. 115-122 ◽  
Author(s):  
Theodor Voiosu ◽  
Ivo Boskoski ◽  
Andrei M. Voiosu ◽  
Andreea Benguș ◽  
Agata Ladic ◽  
...  

Abstract Background Training in advanced endoscopic techniques such as endoscopic retrograde cholangiopancreatography (ERCP) should be driven by key performance measures and standardized competence assessment in order to provide safe and high-quality interventions. We aimed to determine whether the involvement of trainees influences the outcome of the procedure and the incidence of ERCP-related adverse events. Methods This was an international, multicenter, prospective, observational study conducted at six high- and low-volume centers across Europe between October 2016 and October 2018, and included independent operators and their trainees. Standard report forms documenting indication, trainee involvement, technical outcome, and complications over a 30-day follow-up of consecutive ERCP procedures were included in the analysis. Technical success of the procedure and procedure-related adverse events were compared between procedures in the trainee group and the control group using bivariable and multivariable analysis. Results 21 trainees and 16 control endoscopists performed 1843 ERCPs during the study period. Trainee involvement in ERCP procedures did not decrease technical success (92.4 % vs. 93.7 %; P = 0.30) or increase the risk of adverse events (14.7 % vs. 14.6 %; P > 0.99). Conversely, there were significantly more moderate or severe adverse events in the control group compared with the trainee group (6.2 % vs. 3.4 %, P = 0.01). On multivariable analysis, only increased bilirubin levels, time to cannulation, and procedure difficulty level increased the risk of any procedure-related adverse event. Conclusion Trainee involvement in ERCP interventions within a proper teaching setting is safe and does not compromise the success of the procedure.


Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Ahmad A Sherbini ◽  
James M Gwinnutt ◽  
Kimme L Hyrich ◽  
Suzanne M M Verstappen ◽  

Abstract Background/Aims  Methotrexate (MTX) is the most common treatment for rheumatoid arthritis (RA). The prevalence of adverse events (AEs) associated with MTX treatment for RA have been studied extensively, but there are limited data on the predictors of these AEs. This study aims to summarise the prevalence rates of MTX AEs, including gastrointestinal (GI), neurological, mucocutaneous, and elevated alanine transaminase (ALT) enzyme, and to identify baseline demographic and clinical predictors of these AEs. Methods  The Rheumatoid Arthritis Medication Study (RAMS) is a UK multi-centre prospective cohort study of patients with RA starting MTX for the first time. Relevant demographic, medication, clinical and disease related data were collected at baseline. AEs were reported at six and twelve months follow-ups. The prevalence rates of AEs were calculated based on the proportions of patients who reported having had an AE within one year of follow-up. The associations between candidate baseline predictors and AEs were assessed using multivariable logistic regression. Results  A total of 2,089 patients were included with a mean age of 58.4 (standard deviation: 13.5) years, 1390 (66.5%) were women. 1,814 and 1,579 patients completed the 6 and 12 months follow-up visits, respectively. The prevalence rates of the AEs within one year of follow-up were: GI = 777 (40.6%), mucocutaneous = 441 (23.1%), neurological = 487 (25.5%), elevated ALT (&gt; upper limit of normal [ULN]) = 286 (15.5%). Younger age and being a woman were associated with increased risk of GI AEs, (age: OR 0.97 per year increase in age, 95% CI 0.98, 1.00; male sex: OR 0.58 vs female, 95% CI 0.46, 0.74) (Table 1). Higher baseline Health Assessment Questionnaire (HAQ) score was an independent predictor of GI, mucocutaneous, and neurological AEs. Furthermore, having ALT &gt;1xULN at baseline or history of diabetes was associated with increased risk of subsequent ALT elevation during the study follow-up. Conclusion  In patients with RA starting MTX, GI AEs were the most commonly reported AEs during the first year of follow-up. The identified predictors of AEs may facilitate discussions between clinicians and patients prior to commencing MTX, and may lead to increased adherence and consequently improved effectiveness. Disclosure  A.A. Sherbini: None. J.M. Gwinnutt: Grants/research support; BMS. K.L. Hyrich: Member of speakers’ bureau; Abbvie. Grants/research support; Pfizer, UCB, BMS. S.M.M. Verstappen: Consultancies; Celltrion. Member of speakers’ bureau; Pfizer. Grants/research support; BMS.


Viruses ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1427
Author(s):  
Paula Sobral da Silva ◽  
Sophie Eickmann ◽  
Ricardo Ximenes ◽  
Celina Martelli ◽  
Elizabeth Brickley ◽  
...  

The relation of Zika virus (ZIKV) with microcephaly is well established. However, knowledge is lacking on later developmental outcomes in children with evidence of maternal ZIKV infection during pregnancy born without microcephaly. The objective of this analysis is to investigate the impact of prenatal exposure to ZIKV on neuropsychomotor development in children without microcephaly. We evaluated 274 children including 235 ZIKV exposed and 39 controls using the Bayley-III Scales of Infant and Toddler Development (BSIDIII) and neurological examination. We observed a difference in cognition with a borderline p-value (p = 0.052): 9.4% of exposed children and none of the unexposed control group had mild to moderate delays. The prevalence of delays in the language and motor domains did not differ significantly between ZIKV-exposed and unexposed children (language: 12.3% versus 12.8%; motor: 4.7% versus 2.6%). Notably, neurological examination results were predictive of neurodevelopmental delays in the BSIDIII assessments for exposed children: 46.7% of children with abnormalities on clinical neurological examination presented with delay in contrast to 17.8% among exposed children without apparent neurological abnormalities (p = 0.001). Overall, our findings suggest that relative to their unexposed peers, ZIKV-exposed children without microcephaly are not at considerably increased risk of neurodevelopmental impairment in the first 42 months of life, although a small group of children demonstrated higher frequencies of cognitive delay. It is important to highlight that in the group of exposed children, an abnormal neuroclinical examination may be a predictor of developmental delay. The article contributes to practical guidance and advances our knowledge about congenital Zika.


2004 ◽  
Vol 1 (3) ◽  
pp. 223-232 ◽  
Author(s):  
Michael Irwin ◽  
Jennifer Pike ◽  
Michael Oxman

Both the incidence and severity of herpes zoster (HZ) or shingles increase markedly with increasing age in association with a decline in varicella zoster virus (VZV)-specific immunity. Considerable evidence shows that behavioral stressors, prevalent in older adults, correlate with impairments of cellular immunity. Moreover, the presence of depressive symptoms in older adults is associated with declines in VZV-responder cell frequency (VZV-RCF), an immunological marker of shingles risk. In this review, we discuss recent findings that administration of a relaxation response-based intervention,tai chi chih(TCC), results in improvements in health functioning and immunity to VZV in older adults as compared with a control group. TCC is a slow moving meditation consisting of 20 separate standardized movements which can be readily used in elderly and medically compromised individuals. TCC offers standardized training and practice schedules, lending an important advantage over prior relaxation response-based therapies. Focus on older adults at increased risk for HZ and assay of VZV-specific immunity have implications for understanding the impact of behavioral factors and a behavioral intervention on a clinically relevant end-point and on the response of the immune system to infectious pathogens.


2018 ◽  
Vol 118 (11) ◽  
pp. 1930-1939
Author(s):  
Sebastian Göbel ◽  
Jürgen Prochaska ◽  
Lisa Eggebrecht ◽  
Ronja Schmitz ◽  
Claus Jünger ◽  
...  

AbstractPatients with heart failure (HF) are frequently anti-coagulated with vitamin K-antagonists (VKAs). The use of long-acting VKA may be preferable for HF patients due to higher stability of plasma concentrations. However, evidence on phenprocoumon-based oral anti-coagulation (OAC) therapy in HF is scarce. The aim of this study was to assess the impact of the presence of HF on quality of phenprocoumon-based OAC and the subsequent clinical outcome. Quality of OAC therapy and the incidence of adverse events were analysed in a cohort of regular care (n = 2,011) from the multi-centre thrombEVAL study program (NCT01809015) stratified by the presence of HF. To assess the modifiability of outcome, results were compared with data from individuals receiving specialized care for anti-coagulation (n = 760). Overall, the sample comprised of 813 individuals with HF and 1,160 subjects without HF in the regular care cohort. Quality of OAC assessed by time in therapeutic range (TTR) was 66.1% (47.8%/82.8%) for patients with HF and 70.6% (52.1%/85.9%) for those without HF (p = 0.0046). Stratification for New York Heart Classification (NYHA)-class demonstrated a lower TTR with higher NYHA classes: TTRNYHA-I 69.6% (49.4%/85.6%), TTRNYHA-II 66.5% (50.1%/82.9%) and TTRNYHA-≥III 61.8% (43.1%/79.9%). This translated into a worse net clinical benefit outcome for HF (hazard ratio [HR] 1.63 [1.31/2.02]; p < 0.0001) and an increased risk of bleeding (HR 1.40 [1.04/1.89]; p = 0.028). Management in a specialized coagulation service resulted in an improvement of all, TTR (∆+12.5% points), anti-coagulation-specific and non-specific outcome of HF individuals. In conclusion, HF is an independent risk factor for low quality of OAC therapy translating into an increased risk for adverse events, which can be mitigated by specialized care.


2018 ◽  
Vol 25 (5) ◽  
pp. 104-110
Author(s):  
V. S. Uchaeva ◽  
Yu. A. Vasiliev ◽  
A. S. Gracheva ◽  
O. V. Gulenko ◽  
I. G. Udina

Aim. This research was designed to conduct an associative population genetic study for the consideration of the impact of SNP C677T of the gene MTHFR in the congenital maxillofacial developmental anomalies (CMDA): congenital cleft lip (CCL), congenital cleft palate (CCP), congenital cleft lip and palate (CCLP) in the Krasnodar territory. The aim of the study is to establish the associations between SNP C677T of the gene MTHFR and the development of congenital cleft lip and/ or palate.Materials and methods. In this research, the peculiarities of distribution of SNP C667T of the gene MTHFR in children with congenital cleft lip and/or palate (n=223) and their mothers (n=78) in comparison with the control group (n=124) were studied in the Krasnodar territory. The genetic demographic questionnaires were gathered for children with CMDA, the information about diagnosis was obtained from the medical records. The biological samples, including blood or scrapings of oral mucosa, were collected from children with the pathology and their mothers. The DNA was extracted from the samples by the standard method. The study of the peculiarities of distribution of alleles of SNP C677T of the gene MTHFR was performed by PCR-PFLP with endonuclease Hinf I or by tetra-primer ARMS-PCR method in children with CCL, CCP, CCLP, their mothers and the control group. Statistical processing of the obtained data was performed by the algorithms of the “Statistica” program.Results. While comparing the profiles of frequencies of SNP C677T in children with CCL, CCP and CCLP with the control group, there were identified no significant differences in the frequency of this SNP and no peculiarities of genotypes distribution. There was identified a significant difference in the peculiarities of genotypes distribution with the control group (G=19,5232, d.f.=1, p<0,001) as well as united genotypes (С/C и С/T) in accordance to T/T (G=10,4657, d.f.=1; p<0,001) and united genotypes (C/T и T/T) in accordance to C/C (G=15,1896, d.f.=1, p<0,001) for the mothers of children with CCL, CCP and CCLP.Conclusion. As a result of the study, we established the association of SNP C677T of the MTHFR gene with the development of congenital cleft lip and/or palate: mothers’ T/T genotype is associated with the increased risk of giving birth to a child with CCL, CCP and CCLP (in comparison with mothers with C/C+C/T genotype): odds ratio [OR]=16,63, 95% CI: 3,86-71,71; p=0,0003 and also for mothers with genotypes (C/T+T/T) in comparison with mothers with genotypes C/C: OR=3,22, CI:1,71-6,08; p=0,0002. The amount of risk is not significant in children with CMDA for T/T genotype. So it is possible to make a conclusion about the impact of C677T of the gene MTHFR in the development of CCL, CCP and CCLP only in mother’s genotype. 


2021 ◽  
Vol 4 ◽  
pp. 93
Author(s):  
Mary McCarron ◽  
Darren McCausland ◽  
Retha Luus ◽  
Andrew Allen ◽  
Fintan Sheerin ◽  
...  

Background: People with intellectual disability have increased risk of exposure to and adverse outcomes from coronavirus disease 2019 (COVID-19).They also face challenges to mental health and well-being from COVID-19-related social restrictions and service closures. Methods: Data from a supplemental COVID-19 survey from the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA) (n=710) was used to assess outcomes from the first infection wave of COVID-19 among adults with intellectual disability aged 40+ years in Ireland. Data was gathered on testing, for symptoms and outcomes; procedures to manage COVID-19; and both stress/anxiety and positive experiences during the pandemic. Demographic and health-related data from the main IDS-TILDA dataset was included in analyses. Results: High rates were identified of health conditions associated with poorer COVID-19 outcomes, including overweight/obesity (66.6%, n=365), high cholesterol (38.6%, n=274) and cardiovascular disease (33.7%, n=239). Over half (53.5%, n=380) reported emotional, nervous or psychiatric disorders. Almost two-thirds (62.4%, n=443) were tested for COVID-19, with 10% (n=71) reporting symptoms and 2.5% (n=11) testing positive. There were no instances of COVID-19 related mortality. Common symptoms included fatigue, fever, and cough. Some participants (7.8%, n=55) moved from their usual home, most often to isolate (n=31) or relocate to a family home (n=11). Three-quarters (78.7%) of those who were symptomatic or who tested positive had plans to manage self-isolation and two-thirds were able to comply with guidelines. Over half (55%, n=383) reported some COVID-19 related stress/anxiety; and a similar proportion reported positive aspects during this period (58%, n=381). Conclusions: Our data suggests that people with intellectual disability avoided the worst impacts of COVID-19 during the first infection wave in Ireland. Nevertheless, participants’ health profiles suggest that this population remains at high risk for adverse infection outcomes. Repeated measures are needed to track health and well-being outcomes across multiple infection waves.


Author(s):  
Ying Zhang ◽  
Xu Hao ◽  
Kelu Hou ◽  
Lei Hu ◽  
Jingyuan Shang ◽  
...  

Aims: To assess the impact of cytochrome P450 (CYP) 2C19 polymorphisms on the clinical efficacy and safety of voriconazole. Methods: We systematically searched PubMed, EMBASE, CENTRAL, ClinicalTrials.gov, and three Chinese databases from their inception to March 18, 2021 using a predefined search algorithm to identify relevant studies. Studies that reported voriconazole-treated patients and information on CYP2C19 polymorphisms were included. The efficacy outcome was success rate. The safety outcomes included overall adverse events, hepatotoxicity and neurotoxicity. Results: A total of 20 studies were included. Intermediate metabolizers (IMs) and Poor metabolizers (PMs) were associated with increased success rates compared with normal metabolizers (NMs) (risk ratio (RR): 1.18, 95% confidence interval (CI): 1.03~1.34, I2=0%, p=0.02; RR: 1.28, 95%CI: 1.06~1.54, I2=0%, p=0.01). PMs were at increased risk of overall adverse events in comparison with NMs and IMs (RR: 2.18, 95%CI: 1.35~3.53, I2=0%, p=0.001; RR: 1.80, 95% CI: 1.23~2.64, I2=0%, p=0.003). PMs demonstrated a trend towards an increased incidence of hepatotoxicity when compared with NMs (RR: 1.60, 95%CI: 0.94~2.74, I2=27%, p=0.08), although there was no statistically significant difference. In addition, there was no significant association between CYP2C19 polymorphisms and neurotoxicity. Conclusions: IMs and PMs were at a significant higher success rate in comparison with NMs. PMs were significantly associated with an increased incidence of all adverse events compared with NMs and IMs. Researches are expected to further confirm these findings. Additionally, the relationship between hepatotoxicity and CYP2C19 polymorphisms deservers clinical attention.


Author(s):  
Ruben Berrocal Timmons

Objective: Treatment of joint pain with an injection of the amniotic membrane has not been adequately studied. This study retrospectively reviewed Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analgesic usage data from patients treated with the injection of cryopreserved amniotic membrane (CAM) in their knees to determine the impact of treatment on patients’ pain, quality of life, and analgesic usage. Methods: Chart review was conducted on 40 patients. Institutional Review Board (IRB) approval was obtained prior to initiation of the project. The membrane was utilized as per the FDA guidance of 21CFR1271. Retrospective data, including demographics, medical history, pain score, quality of life score, analgesic usage and adverse events, were collected from their medical records for each consenting patient through 6 months after CAM injection. Results: A total of 40 patients were considered in the final analysis. Mean VAS for pain level improved from 7.0 to 2.6 (p<0.001). WOMAC daily activity function score improved from a mean score of 52 to 28 (p<0.001). Opioid and non-steroidal anti-inflammatory drug (NSAID) usage decreased from 97% to 25% (p<0.001). No adverse events were reported. Conclusion: Mean values for VAS and WOMAC scores significantly improved at all time points and the number of patients who used analgesics decreased as compared to baseline. CAM injection into painful knee joints decreases pain, improves physical function, and decreases the use of analgesics in the absence of adverse events.


1991 ◽  
Vol 9 (8) ◽  
pp. 1341-1347 ◽  
Author(s):  
C H Pui ◽  
R K Dodge ◽  
A T Look ◽  
S L George ◽  
G K Rivera ◽  
...  

We studied the frequency, causes, and predictors of adverse events in 624 patients who had completed treatment for acute lymphoblastic leukemia (ALL) in three consecutive total therapy studies (VII, IX, and X, 1972 to 1983). Event-free survival in study X was significantly better overall than that in studies VIII and IX (P less than .0001 by the log-rank test). In study X, 75% of the patients were electively taken off therapy, compared with 54% in studies VIII and IX. However, the risks of having an adverse event during the first 5 years after completion of therapy were remarkably similar: 22% (95% confidence interval, 17% to 29%) in study X versus 24% (20% to 29%) in studies VIII and IX. Bone marrow, testicular, and CNS relapses accounted for the majority of failures in both groups (85% in study X and 92% in studies VIII and IX). Late adverse events consisted largely of hematologic relapses and the development of solid tumors. Black race (P = .001) and leukemia without an anterior mediastinal mass (P = .05) were associated with an increased risk of failure after completion of treatment in the two earlier clinical trials, whereas a lower leukemic cell DNA content (DNA index less than 1.16) was the only predictor of late treatment failure in the more recent trial (P = .019). None of the other presenting features that were examined (eg, age, leukocyte count, and sex) had value as predictors of late failure. Thus, improved treatment altered the impact of specific prognostic factors and the distribution of sites of relapse, but it did not significantly affect the risk of delayed failure.


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