Category: Statistics

Georgian Med News. 2022 Dec;(333):6-12.

ABSTRACT

Following increased cultural awareness, expanded access to care, and decreased stigmatization, the number of transgender individuals seeking gender affirmation surgery such as gender-affirmation mastectomy (GAM) continues to rise. While post-mastectomy breast tissue is often sent for pathologic evaluation, few studies address the utility and standardization of this practice. This literature review evaluates the pathology findings in GAM specimens reported in the medical literature. A systematic review following PRISMA guidelines was performed to evaluate all medical publications related to pathology reports following GAM. The overall type and incidence of benign and malignant breast lesions were analyzed to elucidate which patient characteristics significantly affect the pathology findings. Overall, eight of 488 identified studies met inclusion criteria (1278 patients). The incidence of pre-malignant lesions was 2.42%, including flat epithelial atypia (0.08%), atypical hyperplasia (0.23%), atypical ductal hyperplasia (1.33%), atypical lobular hyperplasia (0.39%), and lobular carcinoma in situ (0.39%).Patient age, hormonal therapy, and family / patient history of breast cancer were inconsistently reported among included studies. Lack of standardized pathologic classification did not permit further statistical analysis. Although patients who undergo GAM are unlikely to have premalignant or malignant findings on breast pathology examination, pathologic evaluation of breast tissue remains common practice. Additional studies, which include a standardized method of pathologic evaluation, are necessary before practice guidelines can be recommended.

PMID:36780614

J Clin Oncol. 2023 Feb 13:JCO2202447. doi: 10.1200/JCO.22.02447. Online ahead of print.

ABSTRACT

PURPOSE: The US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd) for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-low (immunohistochemistry 1 + or immunohistochemistry 2+/in situ hybridization-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

PATIENTS AND METHODS: Approval was based on DESTINY-Breast04, a phase III, randomized, open-label, multicenter trial in patients with unresectable or metastatic HER2-low breast cancer, determined at a central laboratory. A total of 557 patients were randomly assigned (2:1) to receive either T-DXd 5.4 mg/kg intravenously once every 3 weeks (n = 373) or physicians’ choice of chemotherapy (n = 184).

RESULTS: The study met its primary efficacy end point of progression-free survival (PFS) by blinded independent central review assessment in the hormone receptor-positive (HR+) cohort (N = 494) with an estimated hazard ratio (HR) of 0.51(95% CI, 0.40 to 0.64; P < .0001). Key secondary end points were also met, including PFS in the intent-to-treat population with an HR of 0.50 (95% CI, 0.40 to 0.63; P < .0001), overall survival (OS) in the HR+ cohort with an HR of 0.64 (95% CI, 0.48 to 0.86; P = .0028) and OS in the intent-to-treat with an HR of 0.64 (95% CI, 0.49 to 0.84; P = .0010). The safety profile of T-DXd was consistent with previously approved indications, and no new safety signals were observed in this study population.

CONCLUSION: The approval of T-DXd in HER2-low metastatic breast cancer was based on statistically significant and clinically meaningful PFS and OS improvements observed in the DESTINY-Breast04 trial and represents the first approved therapy specifically for the treatment of HER2-low metastatic breast cancer.

PMID:36780610 | DOI:10.1200/JCO.22.02447

Med Ultrason. 2022 Jun 3. doi: 10.11152/mu-3594. Online ahead of print.

ABSTRACT

AIM: Despite several studies and reviews reporting data accuracy of ultrasonography for confirmation of endotracheal intubation, there has been limited pooled evidence summarizing the diagnostic accuracy of this imaging modality, especially based on recent evidence. Hence, the current study reviews the recent literature and conducts a meta-analysis to compare the accuracy of ultrasonography for the confirmation of endotracheal tube placement.

MATERIAL AND METHODS: We conducted a systematic search for all studies reporting the diagnostic accuracy of ultrasonography in the databases of Medline, EMBASE,PubMed Central, ScienceDirect, Google Scholar & Cochrane library from inception till December 2021. Meta-analysis was performed using STATA software “midas” package.

RESULTS: Thirty-eight studies with 3,268 participants were included. Thepooled sensitivity was 98% (95% CI, 97%-99%) and specificity was 95% (95% CI, 90%-98%), respectively. The AUC was 0.98 (95%CI: 0.96-1.00). The pooled DOR was 1090 (95% CI, 408-2910). Pooled LRP was 19 (95% CI, 9-39) and pooled LRN was 0.02 (0.01-0.03). There was significant heterogeneity found in the outcome with significant chi-square tests and I2 statistics > 75%.

CONCLUSION: Findings from our review demonstrate promise in the applicability of ultrasonography as a major diagnostic tool for confirming the endotracheal tube intubation.

PMID:36780595 | DOI:10.11152/mu-3594

JCO Glob Oncol. 2023 Feb;9:e2200295. doi: 10.1200/GO.22.00295.

ABSTRACT

PURPOSE: Formal training in clinical research methodologies is limited in limited-resource countries. Through collaboration among high- and middle-resource settings and in response to an identified need verbalized by regional pediatric oncology practitioners, Pediatric Oncology East & Mediterranean Group and St Jude Global developed a workshop focused on capacity building in research skills. Here, we describe its structure, implementation, and early results.

METHODS: Leveraging virtual capabilities, the format included lectures and small group breakout exercise sessions, for 3 hours per day on 2 consecutive days per week for 2 consecutive weeks. Topics included basics of study design, introduction to health care statistics, research ethics, data registries, and scientific writing. Applicants were required to submit an abstract for a potential research project. Each breakout group selected one abstract for further development and presented the final version in a groupwide session. The participants’ experience was evaluated through an online survey.

RESULTS: Attendance included 29 registrants from 12 countries and six disciplines. Each breakout group was assigned a themed category: cohort studies, clinical trials, or registries. Critical feedback from the breakout sessions helped strengthen the selected projects, which included a retrospective study, a prospective observational study, a prospective interventional study, and a registry proposal. After the workshop, participants were invited to further develop their original abstracts, and three proposals received additional mentoring, one of which was a multi-institutional prospective study that was subsequently submitted through the Pediatric Oncology East & Mediterranean Group network for implementation. The postworkshop survey revealed an overall highly positive experience, and feedback provided potential themes for future workshops.

CONCLUSION: This workshop demonstrated the potential for collaborative network partnerships in targeting research training gaps in pediatric oncology. Lessons learned will be applied to future workshops to strengthen research in limited-resource settings.

PMID:36780591 | DOI:10.1200/GO.22.00295

JCO Oncol Pract. 2023 Feb 13:OP2200712. doi: 10.1200/OP.22.00712. Online ahead of print.

ABSTRACT

PURPOSE: The 21st Century Cures Act mandates the immediate release of clinical information (IRCI) to patients. Immediate sharing of sensitive test results to patients with cancer might have serious unintended consequences for patients and providers.

METHODS: A 22-question REDCap survey was designed by the Association of American Cancer Institutes Physician Clinical Leadership Initiative Steering Committee to explore oncology providers’ opinions on IRCI policy implementation. It was administered twice in 2021 with a 3-month interval. A third survey with a single question seeking providers’ opinions about their adaptation to the IRCI mandate was administered 1 year later to those who had responded to the earlier surveys. The data were analyzed using descriptive statistics such as chi-squared or Fisher’s exact tests for categorical variables. The survey was sent to all Association of American Cancer Institutes cancer center members. In the first or second administration, 167 practitioners answered the survey; 31 responded to the third survey.

RESULTS: Three quarters of the providers did not favor the new requirement for IRCI and 62% encountered questions from patients about results being sent to them without provider interpretation. Only half of the hospitals had a plan in place to deal with the new IRCI requirements. A third survey, for longitudinal follow-up, indicated a more favorable trend toward adoption of IRCI.

CONCLUSION: IRCI for patients with cancer was perceived negatively by academic oncology providers after its implementation. It was viewed to be associated with higher levels of patient anxiety and complaints about the care delivered. Providers preferred to discuss test results with patients before release.

PMID:36780583 | DOI:10.1200/OP.22.00712

PLoS Negl Trop Dis. 2023 Feb 13;17(2):e0010631. doi: 10.1371/journal.pntd.0010631. Online ahead of print.

ABSTRACT

Dengue is among the fastest-spreading vector-borne infectious disease, with outbreaks often overwhelm the health system and result in huge morbidity and mortality in its endemic populations in the absence of an efficient warning system. A large number of prediction models are currently in use globally. As such, this study aimed to systematically review the published literature that used quantitative models to predict dengue outbreaks and provide insights about the current practices. A systematic search was undertaken, using the Ovid MEDLINE, EMBASE, Scopus and Web of Science databases for published citations, without time or geographical restrictions. Study selection, data extraction and management process were devised in accordance with the ‘Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies’ (‘CHARMS’) framework. A total of 99 models were included in the review from 64 studies. Most models sourced climate (94.7%) and climate change (77.8%) data from agency reports and only 59.6% of the models adjusted for reporting time lag. All included models used climate predictors; 70.7% of them were built with only climate factors. Climate factors were used in combination with climate change factors (10.3%), both climate change and demographic factors (10.3%), vector factors (5.1%), and demographic factors (5.1%). Machine learning techniques were used for 39.4% of the models. Of these, random forest (15.4%), neural networks (23.1%) and ensemble models (10.3%) were notable. Among the statistical (60.6%) models, linear regression (18.3%), Poisson regression (18.3%), generalized additive models (16.7%) and time series/autoregressive models (26.7%) were notable. Around 20.2% of the models reported no validation at all and only 5.2% reported external validation. The reporting of methodology and model performance measures were inadequate in many of the existing prediction models. This review collates plausible predictors and methodological approaches, which will contribute to robust modelling in diverse settings and populations.

PMID:36780568 | DOI:10.1371/journal.pntd.0010631

PLoS Genet. 2023 Feb 13;19(2):e1010410. doi: 10.1371/journal.pgen.1010410. Online ahead of print.

ABSTRACT

Admixture graphs are mathematical structures that describe the ancestry of populations in terms of divergence and merging (admixing) of ancestral populations as a graph. An admixture graph consists of a graph topology, branch lengths, and admixture proportions. The branch lengths and admixture proportions can be estimated using numerous numerical optimization methods, but inferring the topology involves a combinatorial search for which no polynomial algorithm is known. In this paper, we present a reversible jump MCMC algorithm for sampling high-probability admixture graphs and show that this approach works well both as a heuristic search for a single best-fitting graph and for summarizing shared features extracted from posterior samples of graphs. We apply the method to 11 Native American and Siberian populations and exploit the shared structure of high-probability graphs to characterize the relationship between Saqqaq, Inuit, Koryaks, and Athabascans. Our analyses show that the Saqqaq is not a good proxy for the previously identified gene flow from Arctic people into the Na-Dene speaking Athabascans.

PMID:36780565 | DOI:10.1371/journal.pgen.1010410

Neurogastroenterol Motil. 2023 Feb 13:e14545. doi: 10.1111/nmo.14545. Online ahead of print.

ABSTRACT

BACKGROUND: Imbalance of the tryptophan (TRP) pathway may influence symptoms among patients with irritable bowel syndrome (IBS). This study explored relationships among different components that contribute to TRP metabolism (dietary intake, stool metabolite levels, predicted microbiome metabolic capability) in females with IBS and healthy controls (HCs). Within the IBS group, we also investigated relationships between TRP metabolic determinants, Bifidobacterium abundance, and symptoms of IBS.

METHODS: Participants with IBS (Rome III) and HCs completed a 28-day diary of gastrointestinal symptoms and a 3-day food record for TRP intake. They provided a stool sample for shotgun metagenomics, 16 S rRNA analyses, and quantitative measurement of TRP by mass spectrometry.

RESULTS: Our cohort included 115 females, 69 with IBS and 46 HCs, with a mean age of 28.5 years (SD 7.4). TRP intake (p = 0.71) and stool TRP level (p = 0.27) did not differ between IBS and HC. Bifidobacterium abundance was lower in the IBS group than in HCs (p = 0.004). Predicted TRP metabolism gene content was higher in IBS than HCs (FDR-corrected q = 0.006), whereas predicted biosynthesis gene content was lower (q = 0.045). Within the IBS group, there was no association between symptom severity and TRP intake or stool TRP, but there was a significant interaction between Bifidobacterium abundance and TRP intake (q = 0.029) in predicting stool character.

CONCLUSIONS: Dietary TRP intake, microbiome composition, and differences in TRP metabolism constitute a complex interplay of factors that could modulate IBS symptom severity.

PMID:36780542 | DOI:10.1111/nmo.14545

Proc Natl Acad Sci U S A. 2023 Feb 21;120(8):e2217331120. doi: 10.1073/pnas.2217331120. Epub 2023 Feb 13.

ABSTRACT

Bayes factors represent a useful alternative to P-values for reporting outcomes of hypothesis tests by providing direct measures of the relative support that data provide to competing hypotheses. Unfortunately, the competing hypotheses have to be specified, and the calculation of Bayes factors in high-dimensional settings can be difficult. To address these problems, we define Bayes factor functions (BFFs) directly from common test statistics. BFFs depend on a single noncentrality parameter that can be expressed as a function of standardized effects, and plots of BFFs versus effect size provide informative summaries of hypothesis tests that can be easily aggregated across studies. Such summaries eliminate the need for arbitrary P-value thresholds to define “statistical significance.” Because BFFs are defined using nonlocal alternative prior densities, they provide more rapid accumulation of evidence in favor of true null hypotheses without sacrificing efficiency in supporting true alternative hypotheses. BFFs can be expressed in closed form and can be computed easily from z, t, χ², and F statistics.

PMID:36780516 | DOI:10.1073/pnas.2217331120

PLoS One. 2023 Feb 13;18(2):e0275431. doi: 10.1371/journal.pone.0275431. eCollection 2023.

ABSTRACT

In today’s world, the key variable for measuring population health is life expectancy (LE). The purpose of this research is to find out how life expectancy is related to other factors and develop a model to account for the predictors that contribute to LE. This study is also conducted to investigate and measure the effect of socioeconomic variables on LE in Bangladesh. In this study, the predictor variables are employment rate, gross national income (GNI), population growth rate, unemployment rate, and age dependency ratio. Path analysis disintegrated bivariate analysis and showed that employment rate, GNI, and age dependency ratio are significantly related to life expectancy, although bivariate analysis showed all variables are significantly related to LE. The maximum values of significant factors, GNI and employment rates, are $1930 and 21.32% happened in 2019, which is positively correlated with life expectancy. Also, the maximum value of the age dependency ratio (81.52%) happened in 1991, whereas the maximum value of the dependent variable LE (72.59 years) happened in 2019. It has been observed that LE, GNI, and employment rates all rise with one another. There exists an adverse relationship between LE and age dependency ratio. Based on comparisons with other highly developed nations, Bangladesh’s GNI needs to grow faster than other significant factors to boost life expectancy. We have forecasted variables that were significantly related to LE until 2030 for the purpose of sustainable development goals, especially the 3rd goal.

PMID:36780510 | DOI:10.1371/journal.pone.0275431