Evidence shows that a substantial proportion of patients with COVID-19 experiences long-term consequences of the disease, but the predisposing factors are poorly understood. We conducted a systematic ...review and meta-analysis to identify factors present during COVID-19 hospitalization associated with an increased risk of exhibiting new or persisting symptoms (Post-COVID-19 Syndrome, PCS). MedLine and WebOfScience were last searched on 30 September 2021. We included English language clinical trials and observational studies investigating prognostic factors for PCS in adults previously hospitalized for COVID-19, reporting at least one individual prospective follow-up of minimum 12 weeks. Two authors independently assessed risk of bias, which was judged generally moderate. Risk factors were included in the analysis if their association with PCS was investigated by at least two studies. To summarize the prognostic effect of each factor (or group of factors), odds ratios were estimated using raw data. Overall, 20 articles met the inclusion criteria, involving 13,340 patients. Associations were statistically significant for two factors: female sex with any symptoms (OR 1.52; 95% CI 1.27-1.82), with mental health symptoms (OR 1.67, 95% CI 1.21-2.29) and with fatigue (OR 1.54, 95% CI 1.32-1.79); acute disease severity with respiratory symptoms (OR 1.66, 95% CI 1.03-2.68). The I² statistics tests were calculated to quantify the degree of study heterogeneity. This is the first meta-analysis measuring the association between factors present during COVID-19 hospitalization and long-term sequelae. The role of female sex and acute disease severity as independent prognostic factors must be confirmed in robust longitudinal studies with longer follow-up. Identifying populations at greatest risk for PCS can enable the development of targeted prevention and management strategies. Systematic review registration: PROSPERO CRD42021253467.
Purpose
Patients undergoing thyroidectomy for differentiated thyroid cancer (DTC) may require 131-radioactive iodine (RAI) administration for remnant ablation or disease treatment. After ingestion, ...RAI resides within the gastrointestinal tract potentially leading to mucosal damage and abnormalities in the absorption of levothyroxine (LT4). The aim of this study was to evaluate whether serum FT4 peak, induced by a LT4 challenge, changes according to the LT4 formulation (solid or liquid) in both RAI and non-RAI-treated DTC patients.
Methods
This was a monocentric controlled clinical trial, with a parallel two-groups (1:1) randomization of sequence of LT4 formulation. Patients received 200 mcg LT4 orally administered at 08:00 h, in both solid and liquid formulation, at one-week interval, at baseline and after 1, 3, and 6 months from RAI administration. At each time-point, circulating FT4 was evaluated both before LT4 assumption as well as after 1 and 3 h. FT4 increments were evaluated as area under the curve response (AUC). Analogous protocol with the same time-intervals was followed for non-RAI patients.
Results
The trial included 29 consecutive DTC patients, nineteen of whom were submitted to RAI. In RAI subjects, we observed an overall significant reduction in serum FT4 increments with the most relevant decrease at the 1-month time-point, (FT4 AUC: 4.46 ± 0.72 (M ± SD) vs 4.07 ± 0.63 in baseline vs 1-month,
P
= 0.001) without any difference between the two LT4 formulations. No difference in serum FT4 AUC was found in non-RAI subjects.
Conclusion
LT4-induced serum FT4 responses are reduced following RAI administration in thyroidectomized DTC patients.
Concern is growing about the negative consequences that response measures to the COVID-19 epidemic may have on the management of other medical conditions.
A retrospective descriptive case-series ...study conducted at a large University-hospital in northern Italy, an area severely hit by the epidemic.
Between 23 February and 14 May 2020, 4160 (52%) COVID-19 and 3778 (48%) non-COVID-19 patients were hospitalized. COVID-19 admissions peaked in the second half of March, a period characterized by an extremely high mortality rate (27.4%). The number of admissions in 2020 was similar to 2019, but COVID-19 patients gradually occupied all available beds. Comparison between COVID-19 and non-COVID-19 admissions in 2020 revealed significant differences concerning all age classes and gender. Specifically, COVID-19 patients were older, predominantly male, and exhibited more comorbidities. Overall, admissions for non-communicable diseases (NCDs) in 2020 vs. 2019 dropped by approximately one third. Statistically significant reductions were observed for acute myocardial infarction (-78, -33.9%), cerebrovascular disease (-235, -41.5%), and cancer (-368, -31.9%). While the first two appeared equally distributed between COVID-19 and non-COVID-19 patients, chronic NCDs were statistically significantly more frequent in the former, except cancer, which was less frequent in COVID-19 patients.
Prevention of collateral damage to patients with other diseases should be an integral part of epidemic response plans. Prospective cohort studies are needed to understand the long-term impact.
This study examined the effects of the routine assessment of patient-reported outcomes (PROs) on the overall survival of adult patients with cancer. We included clinical trials and observational ...studies with a control group that compared PRO monitoring interventions in cancer clinical practice to usual care. The Cochrane risk-of-bias tools were used. In total, six studies were included in the systematic review: two randomized trials, one population-based retrospectively matched cohort study, two pre−post with historical control studies and one non-randomized controlled trial. Half were multicenter, two were conducted in Europe, three were conducted in the USA and was conducted in Canada. Two studies considered any type of cancer, two were restricted to lung cancer and two were restricted to advanced forms of cancer. PRO screening was electronic in four of the six studies. The meta-analysis included all six studies (intervention = 130.094; control = 129.903). The pooled mortality outcome at 1 year was RR = 0.77 (95%CI 0.76−0.78) as determined by the common effect model and RR = 0.82 (95%CI 0.60−1.12; p = 0.16) as determined by the random-effects model. Heterogeneity was statistically significant (I2 = 73%; p < 0.01). The overall risk of bias was rated as moderate in five studies and serious in one study. This meta-analysis seemed to indicate the survival benefits of PRO screening. As routine PRO monitoring is often challenging, more robust evidence regarding the effects of PROs on mortality would support systematic applications.
Minimally invasive surgery (MIS) has recently increased its application in the treatment of gynecological malignancies. Despite technological and surgical advances, urologic complications (UC) are ...still the main concern in gynecology surgery. Current literature reports a wide range of urinary tract injuries, and consistent scientific evidence is still lacking or dated. This study aims to report a large single-center experience of urinary complications during laparoscopic hysterectomy for gynecologic oncologic disease.
All patients who underwent laparoscopic hysterectomy for gynecologic malignancy at the Department of Medicine and Surgery of the University Hospital of Parma from 2017 to 2021 were retrospectively included. Women with endometrial cancer, cervical cancer, ovarian cancer, uterine sarcoma, or borderline ovarian tumors were included. Patients undergoing robotic surgery with incomplete anatomopathological data or patients lost during follow-up were excluded from the analysis. Intraoperative and postoperative UC were analyzed and ranked according to the Clavien-Dindo classification.
Two hundred-sixty patients were included in the study: 180 endometrial cancer, 18 cervical cancer, nine ovarian cancer, two uterine sarcomas, and 60 borderline ovarian tumors. Nine (3.5%) UCs were reported (five intraoperative and four postoperative complications). No anamnestic variables showed a statistical correlation with the surgical complication in the univariable analyses. C1 radical hysterectomy, a higher FIGO stage, and postoperative adjuvant treatment (
-value = 0.001,
-value = 0.046, and
-value = 0.046, respectively) were independent risk factors associated with the occurrence of UC.
The urological complication rates in patients with oncological disease are relatively rare events in the expert hands of dedicated surgeons. Radical hysterectomy, FIGO stage, and adjuvant treatment are independent factors associated with urinary complications.
This meta-analysis of RCTs aimed to determine whether replacing face-to-face hospital care with telemedicine deteriorates psychosocial outcomes of adult cancer patients, in terms of quality of life ...(QoL), anxiety, distress, and depression. RCTs on interventions aimed at improving patient psychosocial outcomes were excluded. MEDLINE, EmBASE, and PsycInfo were searched on 13 May 2022 without language or date restrictions. In total, 1400 records were identified and 8 RCTs included (4434 subjects). Study methodological quality was moderate. Statistically significant improvements were observed in favor of the intervention for QoL (SMD = 0.22, 95% CI 0.01 to 0.43,
= 0.04), anxiety (SMD = -0.17, 95% CI -0.30 to -0.04,
< 0.01), and global distress (SMD = -0.38, 95% CI -0.51 to -0.25,
< 0.01). A meta-analysis on depression could not be performed. In subgroup analyses, the intervention appeared to be more beneficial for patients receiving active treatment vs. follow-up, for "other cancer types" vs. breast cancer, and for "other modes of administration" vs. telephone. Given the many potential advantages of being assisted at home, telemedicine appears to be a viable option in oncology. However, more research is necessary to determine the types of patients who may benefit the most from these alternative care modalities.
Women with pathogenic germline mutations in
BRCA1
and
BRCA2
genes have an increased risk to develop breast and ovarian cancer. There is, however, a high interpersonal variability in the modality and ...timing of tumor onset in those subjects, thus suggesting a potential role of other individual’s genetic, epigenetic, and environmental risk factors in modulating the penetrance of BRCA mutations. MicroRNAs (miRNAs) are small noncoding RNAs that can modulate the expression of several genes involved in cancer initiation and progression. MiRNAs are dysregulated at all stages of breast cancer and although they are accessible and evaluable, a standardized method for miRNA assessment is needed to ensure comparable data analysis and accuracy of results. The aim of this review was to highlight the role of miRNAs as potential biological markers for BRCA mutation carriers. In particular, biological and clinical implications of a link between lifestyle and nutritional modifiable factors, miRNA expression and germline
BRCA1
and
BRCA2
mutations are discussed with the knowledge of the best available scientific evidence.
Clinical Research Coordinators (CRCs) are key members of research teams who ensure rigorous conduction of clinical studies and quality standard compliance. Yet, their roles and responsibilities are ...still not well defined, and formal recognition of their professional profile is lacking in Italy. This survey of Italian healthcare institutions collected data on centers' research activities number of CRCs and tasks they performed and explored factors associated with CRC employment.
Cross-sectional study using a brief questionnaire. Data were analyzed by means of graphical representations, histogram, scatter, and polar plots. Multivariable linear regression was specified to test the association between the number of CRCs and a subset of factors.
Data collection took place from February to December 2020. 62/143 institutions (43.4%) responded. Median number of ongoing studies reported by centers was 65 (IQR 29-205); of these, median of sponsored and interventional studies was 32 and 35, respectively. Median number of CRCs employed at each center was 6 (IQR 2-9). The frequency with which activities were reported to be performed by CRCs overlapped with those of Data Managers. Linear multivariable regression analysis revealed a statistically significant association between the number of employed CRCs and the number of sponsored studies (
= 0.01), but not with the total number of studies, geographical location, or institution type.
The association between industry funding and the number of CRCs observed in this study should be further explored to understand the direction of this relationship and to verify whether this may influence compliance with quality standards.
The development and spread of antibiotic resistance is an increasingly important global public health problem, even in paediatric urinary tract infection (UTI). In light of the variability in the ...data, it is necessary to conduct surveillance studies to determine the prevalence of antibiotic resistance in specific geographical areas to optimize therapeutic management. In this observational, retrospective, multicentre study, the medical records of 1801 paediatric patients who were hospitalised for UTI between 1 January 2012, and 30 June 2020, in Emilia-Romagna, Italy, were analysed. Escherichia coli was the most frequently detected pathogen (75.6%), followed by Klebsiella pneumoniae (6.9%) and Pseudomonas aeruginosa (2.5%). Overall, 840 cases (46.7%) were due to antimicrobial-resistant uropathogens: 83 (4.7%) extended spectrum beta-lactamase (ESBL)-producing, 119 (6.7%) multidrug resistant (MDR) and 4 (0.2%) extensively drug resistant (XDR) bacteria. Empirical antibiotic therapy failed in 172 cases (9.6%). Having ESBL or MDR/XDR uropathogens, a history of recurrent UTI, antibiotic therapy in the preceding 30 days, and empirical treatment with amoxicillin or amoxicillin/clavulanate were significantly associated with treatment failure, whereas first-line therapy with third-generation cephalosporins was associated with protection against negative outcomes. In conclusion, the increase in the resistance of uropathogens to commonly used antibiotics requires continuous monitoring, and recommendations for antibiotic choice need updating. In our epidemiological context, amoxicillin/clavulanate no longer seems to be the appropriate first-line therapy for children hospitalised for UTI, whereas third-generation cephalosporins continue to be useful. To further limit the emergence of resistance, every effort to reduce and rationalise antibiotic consumption must be implemented.
BackgroundIt is possible to induce immunomodulation in HER2-positive breast cancer (BC) by modifying the route of administration of trastuzumab.MethodsIn this multicenter randomized phase II trial, ...all enrolled patients (pts) with T2–T4d HER2-positive BC received 3 cycles of neoadjuvant treatment (NAT) with fluorouracil, epirubicin and cyclophosphamide every 3 weeks (q21), followed by docetaxel/pertuzumab plus intravenous trastuzumab (arm A) or, docetaxel/pertuzumab plus subcutaneous (SC) trastuzumab (arm B) q21x4 cycles. After surgical operation, each pt was treated with trastuzumab q21x14 cycles using the same SC or intravenous formulation of NAT. Primary endpoint was the proportion of subjects with high stromal tumor-infiltrating lymphocytes (sTILs) in postneoadjuvant residual disease (RD).ResultsSixty-three pts (31 (arm A) and 32 (arm B)) were enrolled. Pathological complete response was obtained by 20/31 pts (64.5%; 95% CI 45.4% to 80.1%) in arm A and 19/32 pts (59.4%; 95% CI 40.1% to 76.3%) in arm B. High sTILs were observed in 27% and 46% of postneoadjuvant residual tumors in arms A and B, respectively. CD8+ T cells increased significantly in RDs of both arms (p=0.014 and 0.002 for arm A and B, respectively), whereas a significant decline in the level of CD4+ FoxP3+ regulatory T cells was observed only in arm B (p=0.016). A significant upregulation of PD-1 on sTILs was found in RD of pts enrolled in arm B (p=0.012), while programmed death-ligand 1 (PD-L1) was significantly overexpressed in residual tumors of arm A (p=0.02). A strong negative correlation was reported in arm B between expression of PD-L1 on pretreatment sTILs and CD3 expression on sTILs in RD (τ: −0.73). Grade≥3 AE incidence rates were similar between the two arms.ConclusionsSC trastuzumab induced relevant sTILs enrichment, with favorable variations of immune parameters in HER2-positive BC pts with RD after NAT. Novel immunotherapy strategies should be tested to achieve SC-specific, antitumor immune response.Trial registration numberNCT03144947, and EudraCT number: 2016-000435-41.
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