Category: Statistics

Oncoimmunology. 2023 Oct 30;12(1):2261264. doi: 10.1080/2162402X.2023.2261264. eCollection 2023.

ABSTRACT

Patients with preexisting autoimmune disease (pAID) are generally excluded from clinical trials for immune checkpoint inhibitors (ICIs) for cancer due to concern of flaring pAID. In this multi-center, retrospective observational study, we compared safety of ICI combination (two ICI agents) versus monotherapy in cancer patients with pAIDs. The primary outcome was time to AEs (immune-related adverse events (irAEs) and/or pAID flares), with progression-free survival (PFS) and overall survival as secondary outcomes. Sixty-four of 133 patients (48%) received ICI combination and 69 (52%) monotherapy. Most had melanoma (32%) and lung cancer (31%). Most common pAIDs were rheumatic (28%) and dermatologic (23%). Over a median follow-up of 15 months (95%CI, 11-18 mo), the cumulative incidence of any-grade irAEs was higher for combination compared to monotherapy (subdistribution hazard ratio (sHR) 2.27, 95%CI 1.35-3.82). No statistically significant difference was observed in high-grade irAEs (sHR 2.31 (0.95-5.66), P = .054) or the cumulative incidence of pAID flares. There was no statistically significant difference for melanoma PFS between combination versus monotherapy (23.2 vs. 17.1mo, P = .53). The combination group was more likely to discontinue or hold ICI, but > 50% of the combination group was still able to continue ICI therapy. No treatment-related deaths occurred. In our cohort with pAIDs, patients had a tolerable toxicity profile with ICI combination therapy. Our results support the use of ICI combination if deemed necessary for cancer therapy in patients with pAIDs, since the ICI toxicities were comparable to monotherapy, able to be effectively managed and mostly did not require ICI interruption.

PMID:38126033 | PMC:PMC10732692 | DOI:10.1080/2162402X.2023.2261264

Oncoimmunology. 2023 Nov 27;12(1):2284483. doi: 10.1080/2162402X.2023.2284483. eCollection 2023.

ABSTRACT

The human Epstein-Barr virus (EBV), as a member of the human γ herpes viruses (HHV), is known to be linked with distinct tumor types. It is a double-stranded DNA virus and its genome encodes among others for 48 different microRNAs (miRs). Current research demonstrated a strong involvement of certain EBV-miRs in molecular immune evasion mechanisms of infected cells by, e.g., the disruption of human leukocyte antigen (HLA) class Ia and NKG2D functions. To determine novel targets of EBV-miRs involved in immune surveillance, ebv-miR-BART7-3p, an EBV-encoded miR with high expression levels during the different lytic and latent EBV life cycle phases, was overexpressed in human HEK293T cells. Using a cDNA microarray-based comparative analysis, 234 (229 downregulated and 5 upregulated) deregulated human transcripts were identified in ebv-miR-BART7-3p transfectants, which were mainly involved in cellular processes and molecular binding. A statistically significant downregulation of the anti-proliferative and tumor-suppressive hsa-miR-34A and the anti-viral interferon lambda (IFNL)3 mRNA was found. The ebv-miR-BART7-3p-mediated downregulation of IFNL3 expression was due to a direct interaction with the IFNL3 3′-untranslated region (UTR) as determined by luciferase reporter gene assays including the identification of the accurate ebv-miR-BART7-3p binding site. The effect of ebv-miR-BART7-3p on the IFNL3 expression was validated both in human cell lines in vitro and in human tissue specimen with known EBV status. These results expand the current knowledge of EBV-encoded miRs and their role in immune evasion, pathogenesis and malignant transformation.

PMID:38126030 | PMC:PMC10732682 | DOI:10.1080/2162402X.2023.2284483

Clin Epidemiol. 2023 Dec 16;15:1193-1206. doi: 10.2147/CLEP.S434829. eCollection 2023.

ABSTRACT

PURPOSE: To evaluate the new Clinical Practice Research Datalink (CPRD) Aurum database, we estimated ‘correctness’ (ie accuracy, validity) and ‘completeness’ (ie presence, missingness) of malignant breast cancer diagnoses recorded in CPRD Aurum compared to external linked data sources: Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Outpatient (OP), and Cancer Registry (CR), and to the previously validated CPRD GOLD.

METHODS: Linkage-eligible, female patients with incident malignant breast cancer diagnosis recorded in at least one study data source were selected. Correctness was the proportion of malignant breast cancer cases recorded in CPRD Aurum or GOLD who also had a diagnosis recorded in HES APC/OP (2004-2019) or CR (2004-2016). Completeness was estimated by identifying all malignant breast cancer diagnoses in HES APC/OP or CR and calculating the proportion with a concordant diagnosis in CPRD Aurum or GOLD.

RESULTS: Compared to HES APC/OP, there were 85,659 and 31,452 eligible patients in CPRD Aurum and GOLD, respectively. Correctness estimates were high (CPRD Aurum 83.5%, GOLD 81.7%). Compared to CR, there were 70,190 and 29,597 eligible patients in CPRD Aurum and GOLD, respectively: correctness was 89.1% for CPRD Aurum and 88.2% for GOLD. Completeness estimates for CPRD Aurum and GOLD were high (>90%). Diagnoses were recorded in CPRD Aurum within -7 to 74 days of those in the linked sources. Reasons for discordant diagnostic coding included presence of treatment or other clinical codes only, diagnosis coded after end of follow-up, non-malignant breast cancer in linked data, and administrative codes in lieu of diagnostic codes.

CONCLUSION: These results indicate that correctness and completeness of malignant breast cancer diagnoses in CPRD Aurum were high and similar to CPRD GOLD. This provides confidence in use of CPRD Aurum for research purposes. Where complete case capture is important, researchers should consider linkage to HES APC or CR.

PMID:38126002 | PMC:PMC10731987 | DOI:10.2147/CLEP.S434829

Front Reprod Health. 2023 Dec 6;5:1286920. doi: 10.3389/frph.2023.1286920. eCollection 2023.

ABSTRACT

INTRODUCTION: United States consumers spend over two billion dollars a year on intimate care products. These products, along with scented menstrual products, are marketed for odor control, perceived “freshness,” and vaginal/vulvar cleanliness. However, these scent-altering products may increase exposure to carcinogenic and endocrine-disrupting chemicals. Prior research has not adequately characterized demographic differences in product use. The objective of our study is to examine racial/ethnic and educational differences in menstrual and intimate care product use among people who menstruate.

METHODS: We pooled data from two US-based cross sectional studies to examine demographic characteristics and product use in 661 participants aged 18-54 years. Participants reported use of scented and unscented menstrual products (tampons, sanitary pads, and menstrual cups) and intimate care products (vaginal douches, sprays, wipes, and powders). We examined differences by race/ethnicity and education using log-binomial regression and latent class analysis (LCA), which can identify groups based on product use patterns.

RESULTS: Our sample was 33.4% Black, 30.9% Latina, 18.2% White, and 16.2% another identity. Approximately half the population had a bachelor’s degree or more; 1.4% identified as transgender and 1.8% as non-binary. In adjusted models, scent-altering products (i.e., scented menstrual and intimate care products) were more likely to be used by those with less formal education (p < 0.05). Unscented menstrual products were more likely to be used by those with more formal education. Compared to Black participants, White participants were more likely to use unscented tampons and menstrual cups and less likely to use douches and wipes (p < 0.05). Using LCA we identified two groups: one more likely to use scent-altering products, and a second more likely to use unscented menstrual products. Less education and older age, but not race/ethnicity, was significantly associated with membership in the group more likely to use scent-altering products. While sex/gender composition did not statistically vary across groups, all non-binary participants fell in the unscented menstrual product group.

DISCUSSION: Lower educational attainment was consistently associated with greater use of scent-altering menstrual and intimate care products. Future research should examine associations between body odor stigma, product use, and health risks at intersections of race, class, and gender.

PMID:38126001 | PMC:PMC10731462 | DOI:10.3389/frph.2023.1286920

BMC Cancer. 2023 Dec 20;23(1):1258. doi: 10.1186/s12885-023-11712-6.

ABSTRACT

BACKGROUND: There is paucity of data regarding outcomes of children, adolescents and young adults (CAYA) patients with non-Hodgkin lymphoma (NHL) undergoing autologous stem cell transplantation (ASCT).

METHODS: Patients aged 0-39 years undergoing first ASCT for NHL at MD Anderson Cancer Center between 2000 and 2020 were analyzed.

RESULTS: Two hundred twenty-one patients were included in the analysis, 129 (58%) were male and the median age was 32 (range 6-39) years. The most common histological subtypes were diffuse large B cell lymphoma (DLBCL) (44%), T-NHL (19%) and primary mediastinal B-Cell lymphoma (PMBCL) (19%). Younger patients (age ≤ 25) had lower incidence of DLBCL and higher incidence of PMBCL and T-NHL compared to older patients (age > 25) (P = 0.02). None of the younger patients had double hit (DH)/double expressor (DE) DLBCL, compared to 14 patients in the older age group (18%, P = 0.07). Considering the three main aggressive NHL subtypes (DLBCL, PMBCL and T-NHL), younger patients had numerically better 15-year post-transplant progression free survival (PFS) (67% vs. 54%) and overall survival (OS) (71% vs. 62%) compared to older patients, yet these differences did not reach statistical significance (P = 0.19 and P = 0.24, respectively). In multivariate analysis, not achieving a CR prior to ASCT was independently predictive of worse PFS [partial remission (PR) (HR, 3.9); stable disease (SD) (HR, 18.0), P = 0.03] and of worse OS [PR (HR, 4.2), SD (HR, 6.5) and progressive disease (HR, 4.7), P < 0.0001]. DH/DE status was an independent adverse predictor of PFS in multivariate analysis (HR 5.8, p = 0.03). Ten patients (4.5%) (all aged > 25 years) developed second primary malignancies (SPM), at a median of 34.4 (range, 1.0-196.6) months after ASCT, and SPM was the cause of death in five (50%) of them.

CONCLUSIONS: CAYA NHL patients aged ≤ 25 years who received ASCT presented a distinct NHL histology as compared to older CAYA patients, and none in this younger age group had DH/DE DLBCL. We observed a trend towards improved PFS and OS in younger patients. Disease status at ASCT was predictive of both PFS and OS. DH/DE status was an adverse predictor of PFS.

PMID:38124057 | DOI:10.1186/s12885-023-11712-6

BMC Geriatr. 2023 Dec 20;23(1):876. doi: 10.1186/s12877-023-04555-0.

ABSTRACT

BACKGROUND: Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.

METHODS: This was a single blinded, randomized, matched pairs clinical trial. Sixty-four stroke patients with dysphagia were recruited from patients who had been discharged the Rehabilitation Department of the Third Affiliated Hospital of Sun Yat-sen University. A single blinded, randomized and controlled trial was conducted. Participants were randomly assigned to either the intervention group (n = 32) or the control group (n = 32). Patients in the intervention group received health education followed by swallowing function training in community public spaces for 5 days every week over an eight-week period (60 minutes per day). Patients in the control group received swallowing rehabilitation training, and booster educational information about dysphagia, as well as instructions on how to improve quality of life. Swallowing function (Functional Oral Intake Scale (FOIS) and Standardized Swallowing Assessment (SSA)), depressive symptoms (Geriatric Depression Scale-15), and quality of life (Swallowing-Quality of Life, SWAL-QOL) were assessed before and after all the treatment.

RESULTS: Before treatment, the two groups did not differ statistically. After the intervention, the swallowing function (SSA and FOIS) showed a significant improvement in both groups (All p < 0.001). But there was no significant difference in Functional Oral Intake Scale change between groups (P = 0.479). Compared with the control group, the intervention group had a significant improvement in depressive symptoms (P = 0.002), with a greater reduction in the number of depressed patients (13 to 6).The control group showed no significant improvements in depressive symptoms or a reduction in the number of depressed patients before and after treatment (P = 0.265, 14 to 12). The Swallowing-Quality of Life scores showed significant improvement in both the intervention and control group (P < 0.001). Specifically within Swallowing-Quality of Life sub-domains, greater changes were observed in symptoms and frequency (P < 0.001), communication (P = 0.012), and sleep (P = 0.006) for participants in the intervention group. And the cost-effectiveness of group rehabilitation surpasses that of rehabilitation training.

CONCLUSION: Community-based group rehabilitation program is more effective than traditional treatment in improving patients’ depressive symptoms and quality of life, as well as being more cost-effective.

PMID:38124046 | DOI:10.1186/s12877-023-04555-0

BMC Med Inform Decis Mak. 2023 Dec 20;23(1):295. doi: 10.1186/s12911-023-02392-0.

ABSTRACT

BACKGROUND: Visualising patient genomic data in a cohort with embedding data analytics models can provide relevant and sensible patient comparisons to assist a clinician with treatment decisions. As immersive technology is actively used around the medical world, there is a rising demand for an efficient environment that can effectively display genomic data visualisations on immersive devices such as a Virtual Reality (VR) environment. The VR technology will allow clinicians, biologists, and computer scientists to explore a cohort of individual patients within the 3D environment. However, demonstrating the feasibility of the VR prototype needs domain users’ feedback for future user-centred design and a better cognitive model of human-computer interactions. There is limited research work for collecting and integrating domain knowledge into the prototype design.

OBJECTIVE: A usability study for the VR prototype–Virtual Reality to Observe Oncology data Models (VROOM) was implemented. VROOM was designed based on a preliminary study among medical users. The goals of this usability study included establishing a baseline of user experience, validating user performance measures, and identifying potential design improvements that are to be addressed to improve efficiency, functionality, and end-user satisfaction.

METHODS: The study was conducted with a group of domain users (10 males, 10 females) with portable VR devices and camera equipment. These domain users included medical users such as clinicians and genetic scientists and computing domain users such as bioinformatics and data analysts. Users were asked to complete routine tasks based on a clinical scenario. Sessions were recorded and analysed to identify potential areas for improvement to the data visual analytics projects in the VR environment. The one-hour usability study included learning VR interaction gestures, running visual analytics tool, and collecting before and after feedback. The feedback was analysed with different methods to measure effectiveness. The statistical method Mann-Whitney U test was used to analyse various task performances among the different participant groups, and multiple data visualisations were created to find insights from questionnaire answers.

RESULTS: The usability study investigated the feasibility of using VR for genomic data analysis in domain users’ daily work. From the feedback, 65% of the participants, especially clinicians (75% of them), indicated that the VR prototype is potentially helpful for domain users’ daily work but needed more flexibility, such as allowing them to define their features for machine learning part, adding new patient data, and importing their datasets in a better way. We calculated the engaged time for each task and compared them among different user groups. Computing domain users spent 50% more time exploring the algorithms and datasets than medical domain users. Additionally, the medical domain users engaged in the data visual analytics parts (approximately 20%) longer than the computing domain users.

PMID:38124044 | DOI:10.1186/s12911-023-02392-0

BMC Med Inform Decis Mak. 2023 Dec 20;23(1):297. doi: 10.1186/s12911-023-02407-w.

ABSTRACT

PURPOSE: With the change of lifestyle, the occurrence of coronary artery disease presents a younger trend, increasing the medical and economic burden on the family and society. To reduce the burden caused by this disease, this study applied LASSO Logistic Regression and Random Forest to establish a risk prediction model for premature coronary artery disease(PCAD) separately and compared the predictive performance of the two models.

METHODS: The data are obtained from 1004 patients with coronary artery disease admitted to a third-class hospital in Liaoning Province from September 2019 to December 2021. The data from 797 patients were ultimately evaluated. The dataset of 797 patients was randomly divided into the training set (569 persons) and the validation set (228 persons) scale by 7:3. The risk prediction model was established and compared by LASSO Logistic and Random Forest.

RESULT: The two models in this study showed that hyperuricemia, chronic renal disease, carotid artery atherosclerosis were important predictors of premature coronary artery disease. A result of the AUC between the two models showed statistical difference (Z = 3.47, P < 0.05).

CONCLUSIONS: Random Forest has better prediction performance for PCAD and is suitable for clinical practice. It can provide an objective reference for the early screening and diagnosis of premature coronary artery disease, guide clinical decision-making and promote disease prevention.

PMID:38124036 | DOI:10.1186/s12911-023-02407-w

BMC Public Health. 2023 Dec 20;23(1):2544. doi: 10.1186/s12889-023-17395-9.

ABSTRACT

BACKGROUND: Self-care strategies can improve mental health and wellbeing, however, the evidence on preferred strategies among Arabic-speaking refugees and migrants is unclear. This mixed methods systematic review aimed to identify and synthesise the global research on mental health self-care strategies used by these populations.

METHODS: English and Arabic language studies reporting on positive mental health self-care strategies to address symptoms of posttraumatic stress disorder, generalised anxiety and depression in the target populations were identified by systematically searching eight electronic databases and grey literature. Studies were deemed eligible if they were published from 2000 onwards and included Arabic-speaking migrants, refugees or asylum seekers aged 12 years and above. A narrative synthesis of study characteristics and relevant key findings was undertaken. The review protocol was registered on PROSPERO (registration number CRD42021265456).

RESULTS: Fifty-nine records reporting 57 studies were identified, the majority appearing after 2019. There were 37 intervention studies that incorporated a self-care component and 20 observational studies that reported on self-generated self-care practices. Across both study types, four broad groups of mental health self-care were identified-social, psychological, religious/spiritual, and other (e.g., expressive arts and exercise). Psychological strategies were the most reported self-care practice overall and featured in all intervention studies. Religious/spiritual and social strategies were more common in the observational studies. Intervention studies in diverse settings reported statistical improvements on a range of outcome measures. Observational studies reported a range of individual and community benefits. Linguistic, cultural and religious considerations, inherent in the observational studies, were variably addressed in the individual and group interventions.

CONCLUSION: Overall, study participants experienced self-care as helpful although some encountered challenges in practicing their preferred strategies. Further research on mental health self-care strategies among Arabic-speaking refugees and migrants is needed in Western resettlement countries to guide mental health service delivery and primary healthcare initiatives for new arrivals and in transit countries.

PMID:38124024 | DOI:10.1186/s12889-023-17395-9

Glob Health Sci Pract. 2023 Dec 18. doi: 10.9745/GHSP-D-23-00219. Online ahead of print.

ABSTRACT

INTRODUCTION: Congenital Zika syndrome (CZS) is a health condition that has affected the development of thousands of children in Brazil. Because it is a new condition, its understanding is an ongoing process. Therefore, it is important to know the rehabilitation interventions being delivered to improve the functioning of these children. We aimed to describe the practices of physical therapists (PTs) and occupational therapists (OTs) who provide follow-up care for children with CZS in Brazil.

METHODS: This cross-sectional study included PTs and OTs who assist children with CZS in Brazil. An online questionnaire was used to verify the participants’ personal characteristics and professional work environment, as well as the rehabilitation programs they implemented in Brazil for children with CZS. Data were analyzed using descriptive statistics.

RESULTS: A total of 116 professionals (79 PT and 37 OT) who work mainly in public health services (81.9%) participated in the study. Of these, 24.1% plan interventions based on reading scientific articles, 66.4% did not report using the biopsychosocial model, 52.6% do not perform any assessments before starting an intervention, 31.9% use neurodevelopmental treatment, and 22.4% use sensorimotor stimulation interventions. The majority of the interventions are delivered 1 to 2 times a week, lasting up to 1 hour.

CONCLUSIONS: Professional training and knowledge translation strategies are needed to implement evidence-based practices and improve the quality of rehabilitation programs for Brazilian children with CZS.

PMID:38123996 | DOI:10.9745/GHSP-D-23-00219