Category: Statistics

Cancer Med. 2023 Jan 17. doi: 10.1002/cam4.5530. Online ahead of print.

ABSTRACT

Pancreaticobiliary tract cancer has a poor prognosis with unmet needs in a new target treatment. Some studies have reported that an enhancement of T-cell immunity is associated with a good prognosis. The aim of this study is to investigate the immunoprofile as a prognostic marker of pancreaticobiliary tract cancers. Unresectable pancreatic ductal adenocarcinoma (PDAC, n = 80) and biliary tract cancer (BTC, n = 74) diagnosed between January 2012 and December 2018 in Samsung Medical Center were analyzed. Expression levels of CD8, FOXP3, PD-1, PD-L1, and CXCL13 in PDAC and BTC tissue samples were examined with immunohistochemical staining, which was evaluated with various clinical factors. In PDAC, higher degree of PD-L1 expression was significantly associated with shorter overall survival (OS) (p = 0.0095). On the other hand, higher infiltrations of PD-1⁺ immune cells (p = 0.0002) and CD8⁺ T cells (p = 0.0067) were associated with longer OS. In BTC, higher FOXP3⁺ (p = 0.0343) and CD8⁺ (p = 0.0028) cell infiltrations were associated with better survival. Low infiltration of CD8⁺ (p = 0.0148), FOXP3⁺ (p = 0.0208), PD-1⁺ (p = 0.0318) cells in PDAC, and FOXP3⁺ cells (p = 0.005) in BTC were considerably related to metastasis. In a combined evaluation of clinical factors and immunoprofiles, univariate analysis revealed that operation after chemotherapy (p < 0.0001), mass size (p = 0.0004), metastasis (p = 0.006), PD-L1 (p < 0.0001), PD-1 (p = 0.003) and CD8 (p = 0.0063) was significantly associated with OS in PDAC, and CD8 (p = 0.007) was statistically related to OS in BTC. In multivariate analysis, prognostic factors were operation after chemotherapy (p = 0.021) in PDAC and CD8 (p = 0.037) in BTC. Therefore, immunoprofile analysis of cells expressing CD8, FOXP3, PD-1, and PD-L1 might have prognostic values in patients with pancreaticobiliary tract cancers.

PMID:36650632 | DOI:10.1002/cam4.5530

J Matern Fetal Neonatal Med. 2023 Dec;36(1):2166400. doi: 10.1080/14767058.2023.2166400.

ABSTRACT

OBJECTIVES: We aim to assess if implementation of an educational video module can improve patient adherence to recommended weight gain guidelines. Secondarily, we investigated if patients’ knowledge about gestational weight gain was improved with use of the video, as well as if there was a difference in maternal and neonatal outcomes, and patient satisfaction.

METHODS: This was an IRB-approved, prospective cohort study conducted from February 2019 to October 2019. Patients were recruited from a large academic practice during their first trimester of pregnancy. Patients in the control cohort received routine care. Patients in the video cohort watched a 5-min educational video module about gestational weight gain. Pre-pregnancy weight and baseline demographics were recorded. All patients took a baseline questionnaire assessing gestational weight gain knowledge upon enrollment, and again 4 weeks later. Pre and post score differences were calculated. On admission to the hospital for delivery, all patients’ gestational weight gain was calculated, and the overall gestational weight gain differences between the two groups were calculated. Maternal and neonatal delivery outcomes were also collected. T-tests, Mann-Whitney U tests, and Chi-square analyses were used to compare groups, and a p-value of <.05 was deemed statistically significant.

RESULTS: During the study period, 155 patients were recruited, with 79 in control cohort and 76 in video cohort, respectively. There was no significant difference in the percentage of patients who gained the appropriate amount of weight between the two groups; 25% (18/74) of patients in the control vs. 25% (17/68) of patients in video cohort (p = .926). There was no difference in the improvement of the pre and post assessment scores when compared between the two cohorts; the average score improvement was 1.72 ± 15.09% for the control, vs. 6.20 ± 12.51% for video cohort (p = .129). There was no difference in maternal or neonatal outcomes between the two groups. Patients were overall satisfied with the video module, with 67.6% (n = 45) reporting the video to be very educational.

CONCLUSIONS: Use of a video module did not improve GWG outcomes or knowledge in our study. Future work can focus on use of a recurring intervention throughout pregnancy, either with app-based technology or multiple videos.

PMID:36650631 | DOI:10.1080/14767058.2023.2166400

Clin J Pain. 2023 Feb 1;39(2):68-75. doi: 10.1097/AJP.0000000000001091.

ABSTRACT

OBJECT: To estimate the contrast dispersion short-term clinical efficacy and safety of ultrasound (US)-guided transforaminal steroid injection (TFSI) compared with computed tomography (CT) guidance for the treatment of cervical radicular pain.

METHOD: A total of 430 patients with cervical radicular pain from cervical herniated disk or cervical spondylosis were recruited in the randomized, single-blind, controlled, noninferiority trial. The patients were randomly assigned to receive either the US-guided or CT-guided TFSI for 1 affected cervical nerve. The dispersion pattern of contrast was monitored at the time of TFSI in both groups, using CT. Patients were assessed for pain intensity by numeric rating scale (NrS) and functional disability by Neck Disability Index (NDI) at baseline, 1 and 3 months after the intervention. Complications were also recorded.

RESULTS: The satisfactory rate of contrast distribution was respectively 92.1% in US group and 95.8% in CT group. Pain reduction and functional improvement were showed in both groups during follow-up. Statistical difference was not observed in the decrease in NRS pain scores and NDI scores between 2 groups with F=1.050, P=0.306 at 1 month and F=0.103, P=0.749 at 3 months after intervention. No permanent and severe complications were observed.

CONCLUSIONS: This study demonstrated that US provided a noninferior injectate spread pattern and similar improvement of radicular pain and functional status when compared with CT-guided TFSI. US may be advantageous during this procedure because it allows visualization of critical vessels and avoids radiation exposure.

PMID:36650602 | DOI:10.1097/AJP.0000000000001091

Trials. 2023 Jan 17;24(1):35. doi: 10.1186/s13063-023-07085-7.

ABSTRACT

BACKGROUND: Using functional foods in the prevention and treatment of type 2 diabetes mellitus (T2DM) has increased across the world owing to their availability, cultural acceptability, and lower side effects. The present study will aim to examine the impact of bitter almond (Amygdalus communis L. var. Amara) gum as a functional food on metabolic profile, inflammatory markers, and mental health in women with T2DM.

METHODS: We will conduct a randomized, triple-blind, placebo-controlled trial. A total of 44 women with T2DM will be randomly allocated into two groups: an intervention group (n = 20) and a placebo group (n = 20). Patients will receive either 5 g/d of bitter melon gum or a placebo for 8 weeks. Clinical and biochemical outcome parameters which include glycemic indices, lipid profile, inflammatory markers, oxidative stress indices, tryptophan (Trp), kynurenine (KYN), cortisol, glucagon-like peptide 1 (GLP-1), leptin, adiponectin, ghrelin, peroxisome proliferator-activated receptor (PPAR) gene expression, brain-derived neurotrophic factor (BDNF), endothelial cell adhesion molecules, plasminogen, cluster deference 4 (CD4), cluster deference 8 (CD8), anthropometric indices, blood pressure, dietary intake, and mental health will be measured at the baseline and end of the study. Statistical analysis will be conducted using the SPSS software (version 24), and P value less than 0.05 will be considered statistically significant.

DISCUSSION: The present randomized controlled trial will aim to investigate any beneficial effects of bitter almond gum supplementation on the cardio-metabolic, immune-inflammatory, and oxidative stress biomarkers, as well as mental health in women with T2DM.

ETHICS AND DISSEMINATION: The study protocol was approved by the Ethical Committee of the Tabriz University of Medical Sciences (IR.TBZMED.REC.1399.726).

TRIAL REGISTRATION: Iranian Registry of Clinical Trials ( www.irct.ir/IRCT20150205020965N7 ).

PMID:36650599 | DOI:10.1186/s13063-023-07085-7

Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x.

ABSTRACT

BACKGROUND: In patients with acute respiratory distress syndrome undergoing mechanical ventilation, positive end-expiratory pressure (PEEP) can lead to recruitment or overdistension. Current strategies utilized for PEEP titration do not permit the distinction. Electric impedance tomography (EIT) detects and quantifies the presence of both collapse and overdistension. We investigated whether using EIT-guided PEEP titration leads to decreased mechanical power compared to high-PEEP/FiO2 tables.

METHODS: A single-center, randomized crossover pilot trial comparing EIT-guided PEEP selection versus PEEP selection using the High-PEEP/FiO₂ table in patients with moderate-severe acute respiratory distress syndrome. The primary outcome was the change in mechanical power after each PEEP selection strategy. Secondary outcomes included changes in the 4 × driving pressure + respiratory rate (4 ΔP, + RR index) index, driving pressure, plateau pressure, PaO₂/FiO₂ ratio, and static compliance.

RESULTS: EIT was consistently associated with a decrease in mechanical power compared to PEEP/FiO₂ tables (mean difference – 4.36 J/min, 95% CI – 6.7, – 1.95, p = 0.002) and led to lower values in the 4ΔP + RR index (- 11.42 J/min, 95% CI – 19.01, – 3.82, p = 0.007) mainly driven by a decrease in the elastic-dynamic power (- 1.61 J/min, – 2.99, – 0.22, p = 0.027). The elastic-static and resistive powers were unchanged. Similarly, EIT led to a statistically significant change in set PEEP (- 2 cmH₂O, p = 0.046), driving pressure, (- 2.92 cmH2O, p = 0.003), peak pressure (- 6.25 cmH₂O, p = 0.003), plateau pressure (- 4.53 cmH₂O, p = 0.006), and static respiratory system compliance (+ 7.93 ml/cmH₂O, p = 0.008).

CONCLUSIONS: In patients with moderate-severe acute respiratory distress syndrome, EIT-guided PEEP titration reduces mechanical power mainly through a reduction in elastic-dynamic power. Trial registration This trial was prospectively registered on Clinicaltrials.gov (NCT03793842) on January 4th, 2019.

PMID:36650593 | DOI:10.1186/s13054-023-04315-x

Cancer Imaging. 2023 Jan 17;23(1):7. doi: 10.1186/s40644-023-00523-4.

ABSTRACT

BACKGROUND: The evaluation of treatment response according to METastasis Reporting and Data System for Prostate Cancer (MET-RADS-P) criteria is an important but time-consuming task for patients with advanced prostate cancer (APC). A deep learning-based algorithm has the potential to assist with this assessment.

OBJECTIVE: To develop and evaluate a deep learning-based algorithm for semiautomated treatment response assessment of pelvic lymph nodes.

METHODS: A total of 162 patients who had undergone at least two scans for follow-up assessment after APC metastasis treatment were enrolled. A previously reported deep learning model was used to perform automated segmentation of pelvic lymph nodes. The performance of the deep learning algorithm was evaluated using the Dice similarity coefficient (DSC) and volumetric similarity (VS). The consistency of the short diameter measurement with the radiologist was evaluated using Bland-Altman plotting. Based on the segmentation of lymph nodes, the treatment response was assessed automatically with a rule-based program according to the MET-RADS-P criteria. Kappa statistics were used to assess the accuracy and consistency of the treatment response assessment by the deep learning model and two radiologists [attending radiologist (R1) and fellow radiologist (R2)].

RESULTS: The mean DSC and VS of the pelvic lymph node segmentation were 0.82 ± 0.09 and 0.88 ± 0.12, respectively. Bland-Altman plotting showed that most of the lymph node measurements were within the upper and lower limits of agreement (LOA). The accuracies of automated segmentation-based assessment were 0.92 (95% CI: 0.85-0.96), 0.91 (95% CI: 0.86-0.95) and 75% (95% CI: 0.46-0.92) for target lesions, nontarget lesions and nonpathological lesions, respectively. The consistency of treatment response assessment based on automated segmentation and manual segmentation was excellent for target lesions [K value: 0.92 (0.86-0.98)], good for nontarget lesions [0.82 (0.74-0.90)] and moderate for nonpathological lesions [0.71 (0.50-0.92)].

CONCLUSION: The deep learning-based semiautomated algorithm showed high accuracy for the treatment response assessment of pelvic lymph nodes and demonstrated comparable performance with radiologists.

PMID:36650584 | DOI:10.1186/s40644-023-00523-4

Trials. 2023 Jan 17;24(1):33. doi: 10.1186/s13063-022-07064-4.

ABSTRACT

BACKGROUND: Capturing changes in health and wellbeing within randomised controlled trials (RCTs) can be complex. The precision and accuracy of outcome scales to measure change is crucial, and therefore, consideration needs to be given to potential measurement errors when collecting these outcomes. Many RCTs use multiple researchers to collect data, which has the potential to introduce variation in measurements. This study aimed to identify if there was a measurable effect of using different researchers to collect repeated assessments of quality of life (QoL) at different time points.

METHODS: A previously conducted study assessing the impact of reminiscence therapy on participants with dementia and carer (PwD-carer) dyads, ‘REMCARE’ (Reminiscence groups for people with dementia and their family caregivers), provided the platform for this exploratory secondary analysis. Data was categorised into two broad groups: those where the same researcher attended all assessments and those where different researchers undertook the assessments. ANCOVA (analysis of covariance) models used in the original REMCARE analysis with the addition of the ‘researcher-continuity’ variable were run on two QoL measures, the QoL-AD (Quality of Life in Alzheimer’s Disease) and QCPR (Quality of the Caregiving Relationship).

RESULTS: Three hundred thirty PwD-carer dyads were included in the analysis. For the PwD, a statistically significant effect was found on the researcher continuity variable for the QoL-AD and QCPR outcome measures at follow-up 1 but not at follow-up 2 signifying an impact of researcher attendance at the first follow-up but not follow-up 2. For the carer data, analyses revealed no statistically significant effects at follow-up 1; however, the QoL-AD measure at follow-up 2 was found to be statistically significant.

CONCLUSIONS: These exploratory results indicate the possible impact of researcher continuity on QoL outcomes in dementia studies. Further research is required to explore this further and establish causality. If demonstrated, this would have implications for the planning of future empirical studies in dementia, in order to reduce this potential source of bias.

PMID:36650552 | DOI:10.1186/s13063-022-07064-4

Immun Ageing. 2023 Jan 17;20(1):4. doi: 10.1186/s12979-023-00327-x.

ABSTRACT

BACKGROUND: Immune responses to COVID-19 mRNA vaccines have not been well characterized in frail older adults. We postulated that frailty is associated with impaired antibody and cellular mRNA vaccine responses.

METHODS: We followed older adults in a retirement facility with longitudinal clinical and serological samples from the first Moderna mRNA-1273 vaccine dose starting in February 2021 through their 3rd (booster) vaccine dose. Outcomes were antibody titers, antibody avidity, and AIM+ T cell function and phenotype. Statistical analysis used linear regression with clustered error for antibody titers over multiple timepoints with clinical predictors including, age, sex, prior infection status, and clinical frailty scale (CFS) score. T cell function analysis used linear regression models with clinical predictors and cellular memory phenotype variables.

RESULTS: Participants (n = 15) had median age of 90 years and mild, moderate, or severe frailty scores (n = 3, 7, or 5 respectively). Over the study time course, anti-spike antibody titers were 10-fold higher in individuals with lower frailty status (p = 0.001 and p = 0.005, unadjusted and adjusted for prior COVID-19 infection). Following the booster, titers to spike protein improved regardless of COVID-19 infection or degree of frailty (p = 0.82 and p = 0.29, respectively). Antibody avidity significantly declined over 6 months in all participants following 2 vaccine doses (p < 0.001), which was further impaired with higher frailty (p = 0.001). Notably, avidity increased to peak levels after the booster (p < 0.001). Overall antibody response was inversely correlated with a phenotype of immune-senescent T cells, CD8 + CD28- TEMRA cells (p = 0.036, adjusted for COVID-19 infection). Furthermore, there was increased detection of CD8 + CD28- TEMRA cells in individuals with greater frailty (p = 0.056, adjusted for COVID-19).

CONCLUSIONS: We evaluated the immune responses to the Moderna COVID-19 mRNA vaccine in frail older adults in a retirement community. A higher degree of frailty was associated with diminished antibody quantity and quality. However, a booster vaccine dose at 6 months overcame these effects. Frailty was associated with an increased immune-senescence phenotype that may contribute to the observed changes in the vaccine response. While the strength of our conclusions was limited by a small cohort, these results are important for guiding further investigation of vaccine responses in frail older adults.

PMID:36650551 | DOI:10.1186/s12979-023-00327-x

J Transl Med. 2023 Jan 17;21(1):32. doi: 10.1186/s12967-023-03874-5.

ABSTRACT

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) and prostate cancer (PCa) are among the most prevalent malignant tumors worldwide. There is now a comprehensive understanding of metabolic reprogramming as a hallmark of cancer. Fatty acid synthase (FASN) is a key regulator of the lipid metabolic network, providing energy to favor tumor proliferation and development. Whereas the biological role of FASN is known, its response and sensitivity to inhibition have not yet been fully established in these two cancer settings.

METHODS: To evaluate the association between FASN expression, methylation, prognosis, and mutational profile in PDAC and PCa, we interrogated public databases and surveyed online platforms using TCGA data. The STRING database was used to investigate FASN interactors, and the Gene Set Enrichment Analysis platform Reactome database was used to perform an enrichment analysis using data from RNA sequencing public databases of PDAC and PCa. In vitro models using PDAC and PCa cell lines were used to corroborate the expression of FASN, as shown by Western blot, and the effects of FASN inhibition on cell proliferation/cell cycle progression and mitochondrial respiration were investigated with MTT, colony formation assay, cell cycle analysis and MitoStress Test.

RESULTS: The expression of FASN was not modulated in PDAC compared to normal pancreatic tissues, while it was overexpressed in PCa, which also displayed a different level of promoter methylation. Based on tumor grade, FASN expression decreased in advanced stages of PDAC, but increased in PCa. A low incidence of FASN mutations was found for both tumors. FASN was overexpressed in PCa, despite not reaching statistical significance, and was associated with a worse prognosis than in PDAC. The biological role of FASN interactors correlated with lipid metabolism, and GSEA indicated that lipid-mediated mitochondrial respiration was enriched in PCa. Following validation of FASN overexpression in PCa compared to PDAC in vitro, we tested TVB-2640 as a FASN inhibitor. PCa proliferation arrest was modulated by FASN inhibition in a dose- and time-dependent manner, whereas PDAC proliferation was not altered. In line with this finding, mitochondrial respiration was found to be more affected in PCa than in PDAC. FASN inhibition interfered with metabolic signaling causing lipid accumulation and affecting cell viability with an impact on the replicative processes.

CONCLUSIONS: FASN exhibited differential expression patterns in PDAC and PCa, suggesting a different evolution during cancer progression. This was corroborated by the fact that both tumors responded differently to FASN inhibition in terms of proliferative potential and mitochondrial respiration, indicating that its use should reflect context specificity.

PMID:36650542 | DOI:10.1186/s12967-023-03874-5

BMC Med Educ. 2023 Jan 17;23(1):34. doi: 10.1186/s12909-022-03981-9.

ABSTRACT

OBJECTIVE: To investigate the influence of group counselling on the career planning and career maturity of male nursing students.

METHOD: Sixty male nursing students were randomly selected from a specific-level first-class hospital in Hunan Province from July to August 2020 by using the convenience sampling method and were subsequently divided into the control group and the experimental group using the random number table method. The control group received routine pre-job training, including aspects concerning the hospital profile, nurse etiquette, nursing core systems, professional ethics, nursing emergency treatment and career prospects and planning. In the experimental group, career planning group counselling was added after the regular pre-service training (once a week) with each session lasting 2 h for a total of six training sessions. At six weeks and three months after the intervention, the career status evaluation scale and the college students’ career maturity scale were used to compare the career planning and career maturity status of the two groups of male nursing students.

RESULTS: After six weeks and three months of intervention, all the dimensions and total scores of both the career status evaluation scale and the career maturity scale in the experimental group were superior to those in the control group with statistically significant differences (all P < 0.05). The repeated measures of variance analysis indicated that the differences in the total score for career planning and the four dimensions in terms of intergroup effect, time effect and interaction effect between the two groups were statistically significant (P < 0.05). The intergroup effect, time effect and interaction effect of the total score for vocational maturity, career goal, career confidence, career value, career freedom and career reference of the two groups were statistically significant (P < 0.05), while the time effect of the relative dependency dimension was also statistically significant (P < 0.05).

CONCLUSION: Group counselling can significantly improve the career planning and career maturity status of male nursing students and has a certain long-term effect.

PMID:36650532 | DOI:10.1186/s12909-022-03981-9