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Diagnostic value of radiological staging and surveillance for T1 colorectal carcinomas: A multicenter cohort study

United European Gastroenterol J. 2023 Jun 10. doi: 10.1002/ueg2.12403. Online ahead of print.

ABSTRACT

BACKGROUND: The role of radiological staging and surveillance imaging is under debate for T1 colorectal cancer (CRC) as the risk of distant metastases is low and imaging may lead to the detection of incidental findings.

OBJECTIVE: The aim of this study was to evaluate the yield of radiological staging and surveillance imaging for T1 CRC.

METHODS: In this retrospective multicenter cohort study, all patients of 10 Dutch hospitals with histologically proven T1 CRC who underwent radiological staging in the period 2000-2014 were included. Clinical characteristics, pathological, endoscopic, surgical and imaging reports at baseline and during follow-up were recorded and analyzed. Patients were classified as high-risk T1 CRC if at least one of the histological risk factors (lymphovascular invasion, poor tumor differentiation, deep submucosal invasion or positive resection margins) was present and as low-risk when all risk factors were absent.

RESULTS: Of the 628 included patients, 3 (0.5%) had synchronous distant metastases, 13 (2.1%) malignant incidental findings and 129 (20.5%) benign incidental findings at baseline staging. Radiological surveillance was performed among 336 (53.5%) patients. The 5-year cumulative incidence of distant recurrence, malignant and benign incidental findings were 2.4% (95% confidence interval (CI): 1.1%-5.4%), 2.5% (95% CI: 0.6%-10.4%) and 18.3% (95% CI: 13.4%-24.7%), respectively. No distant metastatic events occurred among low-risk T1 CRC patients.

CONCLUSION: The risk of synchronous distant metastases and distant recurrence in T1 CRC is low, while there is a substantial risk of detecting incidental findings. Radiological staging seems unnecessary prior to local excision of suspected T1 CRC and after local excision of low-risk T1 CRC. Radiological surveillance should not be performed in patients with low-risk T1 CRC.

PMID:37300377 | DOI:10.1002/ueg2.12403

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Lack of an association between first-trimester concentration of mid-regional pro-atrial natriuretic peptide and risk of early-onset preeclampsia <34 weeks' gestation

J Obstet Gynaecol Res. 2023 Jun 10. doi: 10.1111/jog.15700. Online ahead of print.

ABSTRACT

AIM: We examined the heart failure biomarker mid-regional pro-atrial natriuretic peptide during the first trimester of pregnancy in relation to early-onset preeclampsia <34 weeks.

MATERIALS AND METHODS: This case-control study included 34 women with singleton pregnancies with a preeclampsia diagnosis and delivery before 34 weeks of gestation who had attended the routine first-trimester ultrasound scan at 11-13+6 weeks of gestation between August 2010 and October 2015 at the Copenhagen University Hospital Rigshospitalet, Denmark, and 91 uncomplicated singleton pregnancies matched by time of the routine first-trimester blood sampling at 8-13+6 weeks. Descriptive statistical analyses were performed for maternal characteristics and obstetric and medical history for the case versus the control group. Concentrations of mid-regional pro-atrial natriuretic peptide, placental growth factor, soluble fms-like tyrosine kinase-1, and pregnancy-associated plasma protein A between early-onset preeclampsia cases and the control group were compared using Students t-test and the Mann-Whitney U test. Biochemical marker concentrations were converted into multiples of the expected median values after adjustment for gestational age.

RESULTS: Mid-regional pro-atrial natriuretic peptide levels were not significantly different between early-onset preeclampsia cases and the control group in the first trimester of pregnancy. As expected, both placental growth factor and pregnancy-associated plasma protein A levels were significantly lower in early-onset preeclampsia, whereas soluble fms-like tyrosine kinase-1 levels were not statistically significantly different.

CONCLUSION: The maternal first-trimester concentration of mid-regional pro-atrial natriuretic peptide, a peptide with multiple biological functions including a relation to cardiovascular disease, was not significantly different in women with early-onset preeclampsia.

PMID:37300367 | DOI:10.1111/jog.15700

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Outcomes for 41 260 pediatric surgical patients with opioid-free anesthesia: One center’s experience

Paediatr Anaesth. 2023 Jun 10. doi: 10.1111/pan.14705. Online ahead of print.

ABSTRACT

BACKGROUND: Opioid use is common and associated with side effects and risks. Consequently, analgesic strategies to reduce opioid utilization have been developed. Regional anesthesia and multimodal strategies are central tenets of enhanced recovery pathways and facilitate reduced perioperative opioid use. Opioid-free anesthesia (OFA) protocols eliminate all intraoperative opioids, reserving opioids for postoperative rescue treatment. Systematic reviews show variable results for OFA.

METHODS: In a series of Quality Improvement (QI) projects, multidisciplinary teams developed interventions to test and spread OFA first in our ambulatory surgery center (ASC) and then in our hospital. Outcome measures were tracked using statistical process control charts to increase the adoption of OFA.

RESULTS: Between January 1, 2016, and September 30, 2022, 19 872 of 28 574 ASC patients received OFA, increasing from 30% to 98%. Post Anesthesia Care Unit (PACU) maximum pain score, opioid-rescue rate, and postoperative nausea and vomiting (PONV) treatment all decreased concomitantly. The use of OFA now represents our ambulatory standard practice. Over the same timeframe, the spread of this practice to our hospital led to 21 388 of 64 859 patients undergoing select procedures with OFA, increasing from 15% to 60%. Opioid rescue rate and PONV treatment in PACU decreased while hospital maximum pain scores and length of stay were stable. Two procedural examples with OFA benefits were identified. The use of OFA allowed relaxation of adenotonsillectomy admission criteria, resulting in 52 hospital patient days saved. Transition to OFA for laparoscopic appendectomy occurred concomitantly with a decrease in the mean hospital length of stay from 2.9 to 1.4 days, representing a savings of >500 hospital patient days/year.

CONCLUSIONS: These QI projects demonstrated that most pediatric ambulatory and select inpatient surgeries are amenable to OFA techniques which may reduce PONV without worsening pain.

PMID:37300350 | DOI:10.1111/pan.14705

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Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters

Clin Pharmacol Drug Dev. 2023 Jun 10. doi: 10.1002/cpdd.1268. Online ahead of print.

ABSTRACT

To investigate the bioequivalence of miglitol orally disintegrating tablets in healthy Chinese volunteers based on pharmacodynamic (PD) and pharmacokinetic (PK) parameters. Additionally, the safety profile was estimated. Two randomized, open-label, single-dose, crossover trials were conducted under fasting conditions. In the PD trial (CTR20191811), 45 healthy volunteers were randomly divided into 3 groups in a 1:1:1 ratio and administered sucrose alone or coadministered with 50 mg of miglitol orally disintegrating tablet test or reference formulation/sucrose. In the PK trial (CTR20191696), 24 healthy volunteers were randomized (1:1) to receive the test or reference formulation (50 mg). Blood samples were collected at 15 and 17 sampling points per cycle in the PD and PK trials, respectively. Plasma miglitol and serum glucose concentrations were analyzed using a validated liquid chromatography-tandem mass spectrometry method. Serum insulin concentrations were measured using electrochemiluminescent immunoassay. Statistical analyses for the PD and PK parameters were subsequently performed. The volunteers’ physical indicators were monitored and documented during the entire study to estimate drug safety. The PD and PK parameters of the two formulations were similar. The main PD and PK end points were both within the prespecified range of 80%-125%. The incidences of treatment-emergent adverse events (TEAEs) and drug-related TEAEs were similar between the test and reference formulation groups, and no serious TEAEs or deaths occurred during the 2 trials. These 2 formulations were demonstrated to be bioequivalent and well tolerated in healthy Chinese volunteers under fasting condition.

PMID:37300344 | DOI:10.1002/cpdd.1268

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The relationship between critical thinking and job performance among nurses: A descriptive survey study

Int J Nurs Pract. 2023 Jun 10:e13173. doi: 10.1111/ijn.13173. Online ahead of print.

ABSTRACT

AIM: This study investigated the relationship between nurses’ critical thinking skills and job performance and whether critical thinking and its subdomains predict job performance.

BACKGROUND: It is expected that nurses may use critical thinking skills to provide evidence-based quality patient care in health care settings. However, there is limited evidence about whether critical thinking is related to job performance among nurses.

DESIGN: This was a descriptive, cross-sectional survey study.

METHODS: The study included 368 nurses working in the inpatient wards of a university hospital in Turkey. The survey included a demographic information questionnaire, the Critical Thinking Scale in Clinical Practice for Nurses and the Nurses’ Job Performance Scale. The collected data were analysed using descriptive statistics, comparisons, reliability and normality tests, correlation and regression analysis.

RESULTS: Participating nurses got average scores from the critical thinking and job performance scale and sub-scales, and there was a positive, mid-level and statistically significant correlation between the scale scores. According to the multiple linear regression analysis results, personal critical thinking, interpersonal and self-management critical thinking and the total critical thinking scores positively affected the job performance scores of nurses.

CONCLUSION: As critical thinking predicts nurses’ job performance, managers of hospitals and nursing services should consider training programs or activities to increase nurses’ essential thinking competencies, thus improving clinical nurses’ performances.

PMID:37300343 | DOI:10.1111/ijn.13173

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Systematic Analysis of Tissue-Derived and Biofluid Extracellular Vesicle miRNAs Associated with Prostate Cancer

Adv Biol (Weinh). 2023 Jun 9:e2200327. doi: 10.1002/adbi.202200327. Online ahead of print.

ABSTRACT

Extracellular vesicles (EVs) are emerging as biomarker candidates for early detection of prostate cancer. Studies compare EV-microRNA (miRNA) expression in individuals with prostate cancer (PCa) with cancer-free samples for diagnostic purposes. The aim of this study is to review miRNA signatures to investigate the overlap between miRNAs enriched in PCa tissue and miRNAs enriched in EVs isolated from subjects with PCa biofluids (i.e., urine, serum, and plasma). Signatures dysregulated in EVs from PCa biofluids and tissue are potentially associated with the primary tumor site and might be more indicative of PCa at an early stage. A systematic review of EV-derived miRNAs and a reanalysis of PCa tissue miRNA sequencing data for comparison is presented. Articles in the literature are screened for validated miRNA dysregulation in PCa and compared with TCGA primary PCa tumor data using DESeq2. This resulted in 190 dysregulated miRNAs being identified. Thirty-one eligible studies are identified, indicating 39 dysregulated EV-derived miRNAs. The top ten markers identified as significantly dysregulated in the PCa tissue dataset TCGA (e.g., miR-30b-3p, miR-210-3p, miR-126-3p, and miR-196a-5p) have a significant expression change in EVs with the same directionality in one or several statistically significant results. This analysis highlights several less frequently studied miRNAs in PCa literature.

PMID:37300338 | DOI:10.1002/adbi.202200327

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A systematic review and meta-analysis of efficacy and safety of isavuconazole for the treatment and prophylaxis of invasive fungal infections

Mycoses. 2023 Jun 10. doi: 10.1111/myc.13622. Online ahead of print.

ABSTRACT

BACKGROUND: Isavuconazole is a novel triazole antifungal agent. However, the previous outcomes were highlighted by statistical heterogeneity. This meta-analysis aimed to validate the efficacy and safety of isavuconazole for the treatment and prophylaxis of invasive fungal infections (IFIs) compared with other antifungal agents (amphotericin B, voriconazole and posaconazole).

METHODS: Scopus, EMBASE, PubMed, CINAHL and Ichushi databases were searched for relevant articles that met the inclusion criteria through February 2023. Mortality, IFI rate, discontinuation rate of antifungal therapy and incidence of abnormal hepatic function were evaluated. The discontinuation rate was defined as the percentage of therapy discontinuations due to adverse events. The control group included patients who received other antifungal agents.

RESULTS: Of the 1784 citations identified for screening, 10 studies with an overall total of 3037 patients enrolled. Isavuconazole was comparable with the control group in mortality and IFI rate in the treatment and prophylaxis of IFIs, respectively (mortality, odds rate (OR) 1.11, 95% confidential interval (CI) 0.82-1.51; IFI rate, OR 1.02, 95% CI 0.49-2.12). Isavuconazole significantly reduced the discontinuation rate in the treatment (OR 1.96, 95% CI 1.26-3.07) and incidence of hepatic function abnormalities in the treatment and prophylaxis, compared with the control group (treatment, OR 2.31, 95% CI 1.41-3.78; prophylaxis, OR 3.63, 95% CI 1.31-10.05).

CONCLUSIONS: Our meta-analysis revealed that isavuconazole was not inferior to other antifungal agents for the treatment and prophylaxis of IFIs, with substantially fewer drug-associated adverse events and discontinuations. Our findings support the use of isavuconazole as the primary treatment and prophylaxis for IFIs.

PMID:37300337 | DOI:10.1111/myc.13622

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Morphological variation of the Pan talus relative to that of Gorilla

Am J Biol Anthropol. 2023 Jun 10. doi: 10.1002/ajpa.24796. Online ahead of print.

ABSTRACT

OBJECTIVES: Differences in talar articular morphology relative to locomotion have recently been found within Pan and Gorilla. Whole-bone talar morphology within, and shared variation among, Pan and Gorilla (sub)species, however, has yet to be investigated. Here we separately analyze talar external shape within Pan (P. t. troglodytes, P. t. schweinfurthii, P. t. verus, P. paniscus) and Gorilla (G. g. gorilla, G. b. beringei, G. b. graueri) relative to degree of arboreality and body size. Pan and Gorilla are additionally analyzed together to determine if consistent shape differences exist within the genera.

MATERIALS AND METHODS: Talar external shape was quantified using a weighted spherical harmonic analysis. Shape variation both within and among Pan and Gorilla was described using principal component analyses. Root mean square distances were calculated between taxon averages, and resampling statistics conducted to test for pairwise differences.

RESULTS: P. t. verus (most arboreal Pan) talar shape significantly differs from other Pan taxa (p < 0.05 for pairwise comparisons) driven by more asymmetrical trochlear rims and a medially-set talar head. P. t. troglodytes, P. t. schweinfurthii, and P. paniscus do not significantly differ (p > 0.05 for pairwise comparisons). All gorilla taxa exhibit significantly different talar morphologies (p < 0.007 for pairwise comparisons). The more terrestrial subspecies of G. beringei and P. troglodytes exhibit a superoinferiorly taller talar head/neck complex.

DISCUSSION: P. t. verus exhibits talar morphologies that have been previously related to more frequent arboreality. The adaptations in the more terrestrial G. beringei and P. troglodytes subspecies may serve to facilitate load transmission.

PMID:37300336 | DOI:10.1002/ajpa.24796

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Long-term outcomes after paediatric sepsis (LOTUS)-A protocol for an Australian cohort study

Nurs Crit Care. 2023 Jun 9. doi: 10.1111/nicc.12938. Online ahead of print.

ABSTRACT

BACKGROUND: Globally, sepsis has been identified as one of the leading causes of preventable childhood mortality and morbidity. Previous studies on intensive care patients estimated that approximately 30% of children with sepsis experience some form of disability at discharge. Development of care has seen growing numbers of children treated for sepsis not requiring a PICU admission; however, outcomes in this population are yet to be understood. Further focus is required to understand sepsis survivorship across the wider population to address knowledge gaps and morbidity burden in the broader surviving population.

AIMS: To assess the cognitive, physical, emotional and social health of children surviving sepsis 2 years after hospital discharge.

STUDY DESIGN: A prospective, observational cohort study.

RESULTS: Two hundred and thirty-two children will be screened, 2 years after their hospital admission, and approached for participation in this study. Children who are <18 years of age at follow-up, treated for sepsis-related organ dysfunction or septic shock in Queensland between October 2018 and December 2019, will be included. Children who are deceased at follow-up, under care of the state, or require English interpreters will be excluded from participation. Data will be collected through an online follow-up survey comprising validated caregiver-reported questionnaires covering the four Post Intensive Care Syndrome-paediatrics (PICS-p) domains (cognitive, physical, emotional and social health; Manning et al. Pediatr Crit Care Med, 2018, 19, 298-300). The primary outcome is an adaptive behaviour of the participants assessed using the Vinelands-3 tool. Secondary outcomes will include neurodevelopment, quality of life, child distress, overall function, executive function, caregiver’s distress and caregiver’s stress. Analysis of variance (ANOVA), Kruskal-Wallis and Fisher’s exact test/chi-squared tests will be used for statistical analyses. No adjustments will be made for multiple comparisons but it is acknowledged that comparisons made in this study are exploratory.

RELEVANCE TO CLINICAL PRACTICE: With more children surviving sepsis, there is a need for a more comprehensive assessment of patient and family outcomes to allow support structures for families leaving the hospital after sepsis. This study is expected to inform clinicians and stakeholders of patient and family well-being after sepsis survivorship.

PMID:37300332 | DOI:10.1111/nicc.12938

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Awareness of diagnosis predicts changes in quality of life in individuals with mild cognitive impairment and mild stage dementia

Int J Geriatr Psychiatry. 2023 Jun;38(6):e5939. doi: 10.1002/gps.5939.

ABSTRACT

BACKGROUND AND OBJECTIVE: This observational study examined how awareness of diagnosis predicted changes in cognition and quality of life (QOL) 1 year later in older adults with normal cognition and dementia diagnoses.

RESEARCH DESIGN AND METHODS: Older adults (n = 259) with normal cognition, mild cognitive impairment (MCI), or mild stage Alzheimer’s disease (AD) completed measures of diagnostic awareness, cognition, and multiple domains of QOL. We compared 1-year change in cognition and QOL by diagnostic group and diagnostic awareness.

RESULTS: Patients who were unaware of their diagnosis at baseline showed average decreases in both satisfaction with daily life (QOL-AD; paired mean difference (PMD) = -0.9, p < 0.05) and physical functioning (SF-12 PCS; PMD = -2.5, p < 0.05). In contrast, patients aware of their diagnosis at baseline showed no statistically discernable changes in most QOL domains (all p > 0.05). Of patients aware of their diagnosis at baseline (n = 111), those who were still aware (n = 84) showed a decrease in mental functioning at follow up (n = 27; SF-12 MCS). Change in MoCA scores in patients unaware of their diagnosis was similar to that in patients aware of their diagnosis, -1.4 points (95% CI -2.6 to -0.6) and -1.7 points (95% CI -2.4 to -1.1) respectively.

DISCUSSION AND IMPLICATIONS: Awareness of one’s diagnosis of MCI or AD, not the severity of cognitive impairment, may predict changes in patients’ mental functioning, expectations of their memory, satisfaction with daily life, and physical functioning. The findings may help clinicians anticipate the types of threats to wellbeing that a patient might encounter and identify key domains for monitoring.

PMID:37300313 | DOI:10.1002/gps.5939