Quality, integrity and utility of COVID-19 science: opportunities for public health researchers

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Predictivity of clinical, laboratory and imaging findings in diagnostic definition of palpable thyroid nodules. A multicenter prospective study

Abstract PURPOSE: To assess the role of clinical, biochemical, and morphological parameters, as added to cytology, for improving pre-surgical diagnosis of palpable thyroid nodules. METHODS: Patients with a palpable thyroid nodule were eligible if surgical intervention was indicated after a positive or suspicious for malignancy FNAC (TIR 4-5 according to the 2007 Italian SIAPEC-IAP classification), or two inconclusive FNAC at a 653 months interval, or a negative FNAC associated with one or more risk factor. Reference standard was histological malignancy diagnosis. Likelihood ratios of malignancy, sensitivity, specificity, negative (NPV), and positive predictive value (PPV) were described. Multiple correspondence analysis (MCA) and logistic regression were applied. RESULTS: Cancer was found in 433/902 (48%) patients. Considering TIR4-5 only as positive cytology, specificity, and PPV were high (94 and 91%) but sensitivity and NPV were low (61 and 72%); conversely, including TIR3 among positive, sensitivity and NPV were higher (88 and 82%) while specificity and PPV decreased (52 and 63%). Ultrasonographic size 653\u2009cm was independently associated with benignity among TIR2 cases (OR of malignancy 0.37, 95% CI 0.18-0.78). In TIR3 cases the hard consistency of small nodules was associated with malignity (OR: 3.51, 95% CI 1.84-6.70, p\u2009<\u20090.001), while size alone, irrespective of consistency, was not diagnostically informative. No other significant association was found in TIR2 and TIR3. CONCLUSIONS: The combination of cytology with clinical and ultrasonographic parameters may improve diagnostic definition of palpable thyroid nodules. However, the need for innovative diagnostic tools is still high

Concomitant Administration of Capecitabine and Folate Supplements: Need to Encourage Medication Reconciliation

Hand-Foot syndrome (HFS) and diarrhoea are dose-limiting Adverse Drug Reactions (ADRs) of capecitabine-based chemotherapy. Four polymorphisms in the dihydropyrimidine dehydrogenase (DPYD) gene, encoding the DPD enzyme responsible for the metabolism of fluoropyrimidines, such as capecitabine, are strongly associated with severe ADRs, and their screening should be performed before starting treatment. Moreover, capecitabine-related toxicity may worsen due to drug-drug and drug-supplement interactions. Here we investigated factors responsible for severe HFS and diarrhoea presented by two patients, non-carriers of the recommended DPYD single nucleotide polymorphisms (SNPs) but carriers of other genetic variants suggested to increase the risk of capecitabine-related ADRs. Through careful therapy recognition, we demonstrated that, unbeknownst to the oncologists, the patients were taking folic acid during the treatment with capecitabine at a dosage higher than 2000 mg/m(2), which is the maximum tolerated dose when folate is administered. To resolve the ADRs, the therapy had to be drastically changed. In one case, dose reduction of capecitabine and discontinuation of lipid-lowering agents were carried out. In the other case, discontinuation of capecitabine and folic acid and capecitabine re-administration were performed after a month. Genetic and environmental factors should be considered good predictors of severe capecitabine-related toxicity. Medication reconciliation should be encouraged to avoid the harmful consequences of inappropriate treatments

Age-stratified infection fatality rate of COVID-19 in the non-elderly population

The largest burden of COVID-19 is carried by the elderly, and persons living in nursing homes are particularly vulnerable. However, 94% of the global population is younger than 70 years and 86% is younger than 60 years. The objective of this study was to accurately estimate the infection fatality rate (IFR) of COVID-19 among non -elderly people in the absence of vaccination or prior infection. In systematic searches in SeroTracker and PubMed (protocol: https://osf.io/xvupr), we identified 40 eligible national seroprevalence studies covering 38 countries with pre-vaccination seroprevalence data. For 29 countries (24 high-income, 5 others), publicly available age -stratified COVID-19 death data and age-stratified seroprevalence information were available and were included in the primary analysis. The IFRs had a median of 0.034% (interquartile range (IQR) 0.013-0.056%) for the 0-59 years old population, and 0.095% (IQR 0.036-0.119%) for the 0-69 years old. The median IFR was 0.0003% at 0-19 years, 0.002% at 20-29 years, 0.011% at 30-39 years, 0.035% at 40-49 years, 0.123% at 50-59 years, and 0.506% at 60-69 years. IFR increases approximately 4 times every 10 years. Including data from another 9 countries with imputed age distribution of COVID-19 deaths yielded median IFR of 0.025-0.032% for 0-59 years and 0.063-0.082% for 0-69 years. Meta-regression analyses also suggested global IFR of 0.03% and 0.07%, respectively in these age groups. The current analysis suggests a much lower pre-vaccination IFR in non -elderly populations than previously suggested. Large differences did exist between countries and may reflect differences in comorbidities and other factors. These estimates provide a baseline from which to fathom further IFR declines with the widespread use of vaccination, prior infections, and evolution of new variants

The impact of digital patient portals on health outcomes, system efficiency, and patient attitudes. Updated systematic literature review

Background: Patient portals are becoming increasingly popular worldwide even though their impact on individual health and health system efficiency is still unclear. Objective: The aim of this systematic review was to summarize evidence on the impact of patient portals on health outcomes and health care efficiency, and to examine user characteristics, attitudes, and satisfaction. Methods: We searched the PubMed and Web of Science databases for articles published from January 1, 2013, to October 31, 2019. Eligible studies were primary studies reporting on the impact of patient portal adoption in relation to health outcomes, health care efficiency, and patient attitudes and satisfaction. We excluded studies where portals were not accessible for patients and pilot studies, with the exception of articles evaluating patient attitudes. Results: Overall, 3456 records were screened, and 47 articles were included. Among them, 11 studies addressed health outcomes reporting positive results, such as better monitoring of health status, improved patient-doctor interaction, and improved quality of care. Fifteen studies evaluated the impact of digital patient portals on the utilization of health services with mixed results. Patient characteristics were described in 32 studies, and it was reported that the utilization rate usually increases with age and female gender. Finally, 30 studies described attitudes and defined the main barriers (concerns about privacy and data security, and lack of time) and facilitators (access to clinical data and laboratory results) to the use of a portal. Conclusions: Evidence regarding health outcomes is generally favorable, and patient portals have the potential to enhance the doctor-patient relationship, improve health status awareness, and increase adherence to therapy. It is still unclear whether the use of patient portals improves health service utilization and efficiency

Differential COVID-19 infection rates in children, adults, and elderly : Systematic review and meta-analysis of 38 pre-vaccination national seroprevalence studies

Background Debate exists about whether extra protection of elderly and other vulnerable individuals is feasible in COVID-19. We aimed to assess the relative infection rates in the elderly vs the non-elderly and, secondarily, in children vs adults. Methods We performed a systematic review and meta-analysis of seroprevalence studies conducted in the pre-vaccination era. We identified representative national studies without high risk of bias through SeroTracker and PubMed searches (last updated May 17, 2022). We noted seroprevalence estimates for children, non-elderly adults, and elderly adults, using cut-offs of 20 and 60 years (or as close to these ages, if they were unavailable) and compared them between different age groups. Results We included 38 national seroprevalence studies from 36 different countries comprising 826 963 participants. Twenty-six of these studies also included pediatric populations and twenty-five were from high-income countries. The median ratio of seroprevalence in elderly vs non-elderly adults (or non-elderly in general, if pediatric and adult population data were not offered separately) was 0.90-0.95 in different analyses, with large variability across studies. In five studies (all in high-income countries), we observed significant protection of the elderly with a ratio of &lt;0.40, with a median of 0.83 in high-income countries and 1.02 elsewhere. The median ratio of seroprevalence in children vs adults was 0.89 and only one study showed a significant ratio of &lt;0.40. The main limitation of our study is the inaccuracies and biases in seroprevalence studies. Conclusions Precision shielding of elderly community-dwelling populations before the availability of vaccines was indicated in some high-income countries, but most countries failed to achieve any substantial focused protection. Registration Open Science Framework (available at: https://osf.io/xvupr)De två första författarna delar förstaförfattarskapet</p

Mapping and systematic appraisal of umbrella reviews in epidemiological research : a protocol for a meta-epidemiological study

Introduction: Umbrella review is one of the terms used to describe an overview of systematic reviews. During the last years, a rapid increase in the number of umbrella reviews on epidemiological studies has been observed, but there is no systematic assessment of their methodological and reporting characteristics. Our study aims to fill this gap by performing a systematic mapping of umbrella reviews in epidemiological research. Methods: We will perform a meta-epidemiological study including a systematic review in MEDLINE and EMBASE to identify all the umbrella reviews that focused on systematic reviews of epidemiological studies and were published from inception until December 31, 2022. We will consider eligible any research article which was designed as an umbrella review and summarized systematic reviews and meta-analyses of epidemiological studies. From each eligible article, we will extract information about the research topic, the methodological characteristics, and the reporting characteristics. We will examine whether the umbrella reviews assessed the strength of the available evidence and the rigor of the included systematic reviews. We will also examine whether these characteristics change across time. Discussion: Our study will systematically appraise the methodological and reporting characteristics of published umbrella reviews in epidemiological literature. The findings of our study can be used to improve the design and conduct of future umbrella reviews, to derive a standardized set of reporting and methodological guidelines for umbrella reviews, and to allow further meta-epidemiological work

Clinical and organizational impact of the use of different cardiac troponin assays for the diagnosis of myocardial infarction without persistent elevation of the ST segment at presentation (NSTEMI) in 12 Italian emergency departments (EDs): the TROCAR study

: The management of acute chest pain is one of the challenges for emergency departments (EDs) worldwide. This study aims to provide insights into clinical and organizational aspects related to the use of different cardiac troponin tests for the diagnosis of NSTEMI. A prospective observational study was conducted among 12 Italian EDs. Eligible participants had chest pain of suspected cardiac origin and accessed EDs from January 2017 to March 2019. A 30-day follow-up was performed to gather information about the main cardiac outcomes. Tests validity and performance were assessed by computing sensitivity, specificity, positive and negative predictive values and area under the ROC curve. The independent association between adverse event end point at 30&nbsp;days and type of troponin was evaluated by multiple logistic regression models, using odds ratio and 95% confidence interval. 2913 patients were included. Almost 72% were affected by comorbidities and most of them stayed in the EDs for more than 3&nbsp;h, with significant differences among the different troponin assays. The results of follow-up at 30&nbsp;days for the outcomes considered for the patients who were ruled out in 3&nbsp;h or less did not differ significantly compared to those ruled out after 3&nbsp;h or more. After adjustment for confounders, patients admitted to an ED that used a high-sensitivity troponin were at a lower risk of having a MACE (OR = 0.53, 95%CI 0.35-0.90) and a non-significant lower risk of myocardial infarction (OR = 0.68, 95% CI 0.41-1.13, p = 0.1314) at 30&nbsp;days compared to patients admitted to an ED that used a standard troponin. Appropriate troponin testing is extremely important for differential diagnosis and for addressing proper treatment and safe procedures for patients who are not admitted to the hospital

Foregut duplication of the stomach diagnosed by endoscopic ultrasound guided fine-needle aspiration cytology: case report and literature review

Gastric duplication cyst (GDC) with a pseudostratified columnar ciliated epithelium is an uncommon malformation supposed to originate from a respiratory diverticulum arising from the ventral foregut. Morphologic appearance of GDCs is variable, depending on the density of their contents. GDCs are often misdiagnosed as solid masses by imaging techniques, and as a consequence they may be wrongly overtreated. We report our case of a 56-year-old man with a 5 cm hypoechoic mass of the gastroesophageal junction, incidentally detected by transabdominal ultrasonography. Neither transabdominal ultrasonography nor magnetic resonance clearly outlined the features of the lesion. The patient underwent endoscopic ultrasound (EUS), which showed a hypoechoic mass arising from the fourth layer of the anterior gastric wall, just below the gastroesophageal junction. According to EUS features, a diagnosis of gastrointestinal stromal tumor was suggested. EUS-guided fine-needle aspiration cytology revealed a diagnosis of GDC with pseudostratified columnar ciliated epithelium. We therefore performed an endoscopically-assisted laparoscopic excision of the cyst. In conclusion, whenever a subepithelial gastric mass is found in the upper part of the gastric wall, a duplication cyst, although rare, should be considered. In this case, EUS-guided fine-needle aspiration cytology could provide a cytological diagnosis useful to arrange in advance the more adequate surgical treatment

Concomitant Administration of Capecitabine and Folate Supplements: Need to Encourage Medication Reconciliation

Hand-Foot syndrome (HFS) and diarrhoea are dose-limiting Adverse Drug Reactions (ADRs) of capecitabine-based chemotherapy. Four polymorphisms in the dihydropyrimidine dehydrogenase (DPYD) gene, encoding the DPD enzyme responsible for the metabolism of fluoropyrimidines, such as capecitabine, are strongly associated with severe ADRs, and their screening should be performed before starting treatment. Moreover, capecitabine-related toxicity may worsen due to drug-drug and drug-supplement interactions. Here we investigated factors responsible for severe HFS and diarrhoea presented by two patients, non-carriers of the recommended DPYD single nucleotide polymorphisms (SNPs) but carriers of other genetic variants suggested to increase the risk of capecitabine-related ADRs. Through careful therapy recognition, we demonstrated that, unbeknownst to the oncologists, the patients were taking folic acid during the treatment with capecitabine at a dosage higher than 2000 mg/m(2), which is the maximum tolerated dose when folate is administered. To resolve the ADRs, the therapy had to be drastically changed. In one case, dose reduction of capecitabine and discontinuation of lipid-lowering agents were carried out. In the other case, discontinuation of capecitabine and folic acid and capecitabine re-administration were performed after a month. Genetic and environmental factors should be considered good predictors of severe capecitabine-related toxicity. Medication reconciliation should be encouraged to avoid the harmful consequences of inappropriate treatments