Category: Statistics

Rambam Maimonides Med J. 2023 Oct 29;14(4). doi: 10.5041/RMMJ.10508.

ABSTRACT

BACKGROUND: Human papillomavirus (HPV) is considered to be responsible for 95% of virus-related cancers in many organs. Oropharyngeal carcinoma (OC) is distinguished by the transformation of the healthy epithelium into precancerous cells.

AIM: The current study sought to examine the uneven gene expression of 20 genes among those scanned by microarray for oropharyngeal cancer patients.

MATERIALS AND METHODS: The GSE56142 dataset was extracted from the Gene Expression Omnibus of the National Center for Biotechnology Information; 24 specimens were evaluated. Gene ontology (GO), the Kyoto Encyclopedia of Genes and Genomes, and the protein-protein interaction (PPI) were used to depict the biological roles of the genes under investigation using types of software.

RESULTS: Six genes out of 20 in patients with invasive OC had a binding correlation with high expression (PDGFRS, COL6A3, COL1A1, COL3A1, COL2A1, and COL4A1), and only two genes with low expression (CRCT1 and KRT78). The expression levels of 20 genes were examined for patients with OC versus head and neck squamous cell carcinoma (HNSCC). The correlation coefficient between highly expressed genes of the OC group was statistically significant at the P<0.05 level.

CONCLUSIONS: High expression levels of specific genes may serve as diagnostic tumor markers, particularly in the early stages of cancer, and testing should be performed in OC and HNSCC patients.

PMID:37917867 | DOI:10.5041/RMMJ.10508

Psychiatr Danub. 2023 Fall;35(3):335-343. doi: 10.24869/psyd.2023.335.

ABSTRACT

BACKGROUND: In this study, we aimed to investigate the relationship between affective temperament characteristics and obsessive-compulsive disorder (OCD) symptom dimensions and severity.

SUBJECTS AND METHODS: 100 patients diagnosed with OCD and 100 healthy controls by random sampling method were included in the study. SCID-5-CV was administered to all participants. Dimensional Obsessive-Compulsive Scale (DOCS), Temperament Evaluation of Memphis, Pisa, Paris, San Diego Autoquestionnaire (TEMPS-A), Beck Anxiety (BAI), Depression Inventories (BDI) were provided to all participants. p<0.05 was taken as statistically significant.

RESULTS: It was found that cyclothymic temperament predicted all OCD symptom dimensions except contamination dimension, and predicted the OCD severity. Moreover, irritable temperament predicted the OCD symmetry dimension.

CONCLUSION: In our study, the first study in terms of scrutinizing the relationship between symptom dimensions of OCD and affective temperament, it was revealed that irritable and cyclothymic temperament significantly predicted the dimensions of OCD, and cyclothymic temperament was associated with OCD severity. Affective temperaments appear to make a remarkable contribution to OCD heterogeneity.

PMID:37917839 | DOI:10.24869/psyd.2023.335

Psychotherapy (Chic). 2023 Nov 2. doi: 10.1037/pst0000512. Online ahead of print.

ABSTRACT

Alexithymia is the inability to identify and recognize emotions. The present study examined the impact of alexithymia on prolonged exposure (PE) therapy. Participants (n = 68) with PTSD underwent 10 PE sessions. Alexithymia was assessed via the Toronto Alexithymia Scale (TAS-20) and the emotional clarity and awareness subscales of the Difficulties in Emotion Regulation Scale. Treatment outcomes were assessed via the PTSD checklist and Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at posttreatment and 6-month follow-up. Those with high alexithymia were more likely to endorse experiencing a full PTSD diagnosis immediately posttreatment, χ²(1) = 12.53, p = .002, and at 6-month follow-up, χ²(1) = 11.21, p = .004. Alexithymia was associated with delayed treatment effects on avoidance, with a significant reduction in symptomology observed from pre- to follow-up, t(51) = 4.52, p < .001, and not from pre- to posttreatment. Although both the low and high alexithymia groups showed significant changes in negative changes in thinking and mood, F(2, 14) = 9.18, p = .001, d = 1.57 and F(2, 50) = 13.86, p = .001, d = 1.49, respectively, the high alexithymia group exhibited a marginally lesser magnitude of treatment effect. Although those with significantly greater difficulties with emotional clarity were more likely to drop out of PE treatment, emotional clarity and awareness did not moderate treatment response. Our results confirm the efficacy of PE but also highlight that those with alexithymia show a delayed treatment response and may be at greater risk of pathology after treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:37917810 | DOI:10.1037/pst0000512

PLoS One. 2023 Nov 2;18(11):e0292964. doi: 10.1371/journal.pone.0292964. eCollection 2023.

ABSTRACT

In a healthcare system based on managed competition, health insurers are intended to be the prudent buyers of care on behalf of their enrollees. Equally, citizens are expected to be critical consumers when choosing a health insurance policy. The choice of a health insurance policy may be related to trust in the health insurer, as enrollees must believe that the health insurer will make the right choices for them when it comes to purchasing care. This study aims to investigate how enrollees’ trust in health insurers is associated with their choice of a health insurance policy in the Netherlands. We will focus on the switching behaviour of enrollees and the choice of a policy with restrictive conditions. In February 2022, a questionnaire was sent to a representative sample regarding gender and age of the adult Dutch population. In total 1,125 enrollees responded, a response rate of 56%. Respondents were asked about the choices they made in choosing health insurance. Trust in health insurers was measured using the Health Insurer Trust Scale (HITS), a validated multiple item scale. Descriptive statistics, a paired t-test and logistic regression models were conducted to analyse the results. Of all respondents, 35% indicated that they agree, or completely agree, with the statement that they trust health insurers completely. In addition, trust in enrollees’ own insurer is slightly higher than trust in other insurers (36.29 vs. 33.59, p<0.001). Furthermore, we found no significant associations between trust in health insurers, and whether enrollees have either switched health insurers or have chosen a policy with restrictive conditions. This study showed that enrollees’ trust in health insurance in the Netherlands is relatively low and that trust in their own insurer is slightly higher than trust in other insurers. Furthermore, this study does not show a relationship between trust in health insurers and, either switching health insurers, or choosing a policy with restrictive conditions. Nevertheless, attention for increasing the trust in health insurers might still be important, as low trust may have negative consequences for other elements of the functioning of the healthcare system.

PMID:37917768 | DOI:10.1371/journal.pone.0292964

Surg Endosc. 2023 Nov 2. doi: 10.1007/s00464-023-10514-y. Online ahead of print.

ABSTRACT

BACKGROUND: Radical gastrectomy is composed of gastrectomy, lymph node dissection, and omentectomy. Total omentectomy (TO) is expected to reduce the incidence of peritoneal recurrence. We aimed to investigate the necessity of TO for advanced gastric cancer (AGC) with serosal invasion.

METHODS: We retrospectively reviewed 310 patients who underwent radical gastrectomy with TO and 93 patients who underwent partial omentectomy (PO) for gastric cancer with serosal invasion between August, 2005 and December, 2017. Finally, 91 patients in the PO group and 91 in the TO group were enrolled based on a 1:1 propensity-score matching analysis. We evaluated surgical and oncological outcomes, including 5-year overall and recurrence-free survival rates.

RESULTS: There was no statistically significant difference between the two groups in postoperative complications. Recurrence sites showed similar patterns in both groups, including peritoneal recurrence (PO vs. TO, 18.7% vs. 28.6%; p = 0.188). Five-year overall survival was better in the PO group (p = 0.018), while 5-year recurrence-free survival was similar in both groups (p = 0.066).

CONCLUSION: TO might not be an essential part of preventing peritoneal recurrence for AGC with serosal invasion. PO could be considered a radical gastrectomy for T4a gastric cancer.

PMID:37917161 | DOI:10.1007/s00464-023-10514-y

Arch Gynecol Obstet. 2023 Nov 2. doi: 10.1007/s00404-023-07261-9. Online ahead of print.

ABSTRACT

PURPOSE: Office hysteroscopy (OH) is a commonly performed procedure, although it might be associated with some degree of pain and anxiety. Our aim was to determine the effects of virtual reality on pain and anxiety levels felt by patients undergoing OH.

METHODS: MEDLINE, Embase, Google Scholar, Cochrane Library, clinicaltrials.gov, ProQuest, Grey literature, and manual searching of references within studies found in the initial search were systematically searched using the terms ‘Virtual Reality’ and ‘Hysteroscopy’ without time or language limitations. The review considered all studies assessing the impact of virtual reality (VR) over OH outcomes, and prospective randomized trials were included in the meta-analysis. Retrospective and case – control studies were excluded from the meta-analysis.

RESULTS: We identified 17 studies, of which four randomized controlled studies were included in the meta-analysis (327 participants, 168 in the VR group and 159 in the control group). On a 0-10 scale, pain sensation and maximal pain sensation during the operation were not statistically different between study and control groups (relative risk (RR) = -0.64, 95% C.I (-1.57)0.29) and (RR = -0.93, 95% C.I (-3.33) – 1.47), respectively. Anxiety measurement was statistically lower in the study group (RR = -1.73, 95% C.I (-2.79) – ( -0.67)).

CONCLUSIONS: The available data suggest that VR techniques do not decrease the pain sensation during OH however, they do contribute to a reduction in the anxiety levels experienced by patients. PROSPERO registration number CRD42023432819.

PMID:37917158 | DOI:10.1007/s00404-023-07261-9

Elife. 2023 Nov 2;12:e90623. doi: 10.7554/eLife.90623.

ABSTRACT

To enhance inclusivity and rigor, many funding agencies and journals now mandate the inclusion of females as well as males in biomedical studies. These mandates have enhanced generalizability and created unprecedented opportunities to discover sex differences. However, education in sound methods to consider sex as a subgroup category has lagged behind, resulting in a problematic literature in which study designs, analyses, and interpretations of results are often flawed. Here, we outline best practices for complying with sex-inclusive mandates, both for studies in which sex differences are a primary focus and for those in which they are not. Our recommendations are organized within the “4 Cs of Studying Sex to Strengthen Science: Consideration, Collection, Characterization and Communication,” a framework developed by the Office of Research on Women’s Health at the National Institutes of Health in the United States. Following these guidelines should help researchers include females and males in their studies while at the same time upholding high standards of rigor.

PMID:37917121 | DOI:10.7554/eLife.90623

Thyroid. 2023 Nov 2. doi: 10.1089/thy.2023.0338. Online ahead of print.

ABSTRACT

BACKGROUND: Nasolacrimal duct obstruction (NLDO) is an adverse effect of high dose radioactive iodine (RAI) therapy for thyroid carcinoma. There are currently no established preventive measures. This study assesses whether preservative free artificial tears (PFATs) can decrease the 131I sodium iodide (I-131) activity in the tears of patients following radioactive iodine (RAI) therapy for thyroid carcinoma, and potentially serve as a preventive measure for RAI-associated NLDO.

METHODS: This non-randomized prospective pilot clinical trial recruited contact-lens wearing patients undergoing RAI therapy for thyroid cancer to self-administer PFATs into the right eye for 4 days starting on the day of RAI ingestion. Left eyes were the controls. While wearing contacts, patients self-administered PFATs per the following – Day 1: every 15 minutes for 2 hours, then every 30 minutes until bedtime, Day 2: every hour for at least 12 hours, Day 3: four times a day, and Day 4: two times a day. Contact lenses were changed daily, and all lenses were collected one week later. Levels of I-131 activity were measured by a well counter, decay-corrected, and converted to units of Bequerel (Bq). Statistical analyses were performed to compare the I-131 activities of the experimental and control eyes.

RESULTS: Sixteen eyes of 8 patients treated with an average of 145.7 millicuries (range 108-159) of I-131 for papillary thyroid cancer were included. On Day 1, artificial tears decreased the geometric mean I-131 activity by 26% in the experimental eyes (p=0.008). Artificial tears also decreased the geometric mean area under the curve (AUC) over four days by 23% (p=0.002).

CONCLUSIONS: I-131 is present in the tears following RAI therapy for thyroid carcinoma. Frequent PFATs starting on the day of RAI ingestion may decrease the level of I-131 in the tears. This finding could have implications for lowering the risk of NLDO. Future multi-center clinical trials are needed to determine if the use of artificial tears after RAI therapy may decrease the risk of NLDO.

CLINICAL TRIAL REGISTRATION: NCT04327999.

PMID:37917111 | DOI:10.1089/thy.2023.0338

Thyroid. 2023 Nov 2. doi: 10.1089/thy.2023.0456. Online ahead of print.

ABSTRACT

OBJECTIVE: Redifferentiation therapy (RDT) can restore radioactive iodine (RAI) uptake in differentiated thyroid cancer (DTC) cells to enable salvage I-131 therapy for previously RAI refractory (RAIR) disease. This study evaluated the clinical outcomes of patients that underwent RDT and identified clinicopathologic characteristics predictive of RAI restoration following RDT.

METHODS: This is a retrospective case series of 33 patients with RECIST-progressive metastatic RAIR-DTC who underwent RDT between 2017 and 2022 at the Mayo Clinic Rochester. All patients underwent genomic profiling and received MEK, RET or ALK inhibitors alone or combination BRAF-MEK inhibitors for 4 weeks. At week 3, those with increased RAI avidity in metastatic foci received high dose I-131 therapy. Baseline and clinicopathologic outcomes were comprehensively reviewed.

RESULTS: Of the 33 patients, 57.6% had restored RAI uptake following RDT (Redifferentiated subgroup). 42.1% (8/19) with papillary thyroid cancers (PTC), 100% (4/4) with invasive encapsulated follicular variant PTCs (IEFV-PTC), and 100% (7/7) with follicular thyroid cancers (FTC) redifferentiated. All (11/11) RAS mutant tumors redifferentiated compared to 38.9% (7/18) with BRAF mutant disease (6 PTC and 1 IEFV-PTC). 76.5% (13/17) of redifferentiated and 66.7% (8/12) of non-redifferentiated patients achieved a best overall RECIST response of stable disease (SD) or non-complete response/non-progressive disease. Both subgroups had a median 12% tumor shrinkage at three weeks on drug(s) alone. The redifferentiated subgroup, following high dose I-131 therapy, achieved an additional median 20% tumor reduction at 6 months after RDT. There were no statistically significant differences between both groups in progression free survival (PFS), time to initiation of systemic therapy and time to any additional therapy. Of the entire cohort, 6.1% (2/33) experienced histologic transformation to anaplastic thyroid cancer and 15.1% (5/33) died, all had redifferentiated following RDT and received I-131 therapy.

CONCLUSION: RDT has the potential to restore RAI avidity and induce RECIST responses following I-131 therapy in select patients with RAIR-DTC, particularly those with RAS-driven ‘follicular’ phenotypes. In patients with PTC, none of the evaluated clinical outcomes differed statistically between the redifferentiated and non-redifferentiated subgroups. Further studies are needed to better characterize the long-term survival and/or safety outcomes of high-dose RAI following RDT, particularly whether it could be associated with histologic anaplastic transformation.

PMID:37917101 | DOI:10.1089/thy.2023.0456

J Endourol. 2023 Nov 2. doi: 10.1089/end.2023.0430. Online ahead of print.

ABSTRACT

BACKGROUND: Holmium laser enucleation of the prostate (HoLEP) has emerged as a new gold standard for treatment of benign prostatic hyperplasia (BPH); however, its steep learning curve hinders generalization of this technique. Therefore, there is a need for a benchtop HoLEP simulator to reduce this learning curve and provide training. We have developed a non-biohazardous HoLEP simulator using modern education theory and validated it in a multicenter study.

MATERIALS AND METHODS: Six experts established key components for a HoLEP simulator via a Delphi consensus over three rounds including 250 questions. Following consensus, a digital design was created and approved by experts, then used to fabricate a physical prototype using 3D printing and hydrogel molding. After a process of iterative prototype testing, experts completed a survey assessing the simulator with a five-point Likert scale for final approval. The approved model was validated with 56 expert and novice participants at seven institutions using subjective and objective performance metrics.

RESULTS: Consensus was reached on 85/250 questions and experts found the physical model to adequately replicate 82.5% of required features. Objective metrics were statistically significant (p<0.0001) when comparing experts and novices for procedure time (37.4 +/- 8.2 vs 16.7+/- 6.8 min), adenoma weight (79.6+/- 20.4 vs 36.2 +/- 9.9 gm), and complications (6 vs 22) respectively.

CONCLUSION: We have successfully completed a multi-center study to develop and validate a non-biohazardous benchtop simulator for HoLEP through modern education theory. A training curriculum including this simulator is currently under development.

PMID:37917099 | DOI:10.1089/end.2023.0430