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Nevin Manimala Statistics

Differentiation of cancer of unknown primary and lymphoma in head and neck metastatic poorly differentiated cancer using 18F-FDG PET/CT tumor metabolic heterogeneity index

Nucl Med Commun. 2023 Dec 14. doi: 10.1097/MNM.0000000000001797. Online ahead of print.

ABSTRACT

OBJECTIVE: To explore the value of 18F-FDG PET/CT tumor metabolic heterogeneity index (HI) and establish and validate a nomogram model for distinguishing head and neck cancer of unknown primary (HNCUP) from lymphoma with head and neck metastatic poorly differentiated cancer.

METHODS: This retrospective analysis was conducted on 1242 patients with cervical metastatic poorly differentiated cancer. 108 patients, who were clinically and pathologically confirmed as HNCUP or lymphoma, were finally enrolled. Two independent sample t-tests and χ2 test were used to compare the clinical and imaging features. Binary logistic regression was used to screen for independent predictive factors.

RESULTS: Among the 108 patients), 65 patients were diagnosed with HNCUP and 43 were lymphoma. Gender (P = 0.001), SUVmax (P < 0.001), SUVmean (P < 0.001), TLG (P = 0.012), and HI (P < 0.001) had statistical significance in distinguishing HNCUP and lymphoma. Female (OR = 4.546, P = 0.003) and patients with HI ≥ 2.37 (OR = 3.461, P = 0.047) were more likely to be diagnosed as lymphoma.

CONCLUSION: For patients with cervical metastatic poorly differentiated cancer, gender and HI were independent predictors of pathological type. For such patients, clinical attention should be paid to avoid misdiagnosing lymphoma as HNCUP, which may delay treatment.

PMID:38095143 | DOI:10.1097/MNM.0000000000001797

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Nevin Manimala Statistics

Play brick therapy to aid the social skills of children and young people with autism spectrum disorder: the I-SOCIALISE cluster RCT

Public Health Res (Southampt). 2023 Nov;11(12):1-137. doi: 10.3310/VGTR7431.

ABSTRACT

BACKGROUND: Social skills interventions are commonly recommended to help children and young people with autism spectrum disorder develop social skills, but some struggle to engage in these interventions. LEGO® (LEGO System A/S, Billund, Denmark) based therapy, a group social skills intervention, aims to be more interesting and engaging.

OBJECTIVE: To evaluate the clinical effectiveness of LEGO® based therapy on the social and emotional skills of children and young people with autism spectrum disorder in school settings compared with usual support. Secondary objectives included evaluations of cost-effectiveness, acceptability and treatment fidelity.

DESIGN: A cluster randomised controlled trial randomly allocating participating schools to either LEGO® based therapy and usual support or usual support only.

SETTING: Mainstream schools in the north of England.

PARTICIPANTS: Children and young people (aged 7-15 years) with autism spectrum disorder, their parent/guardian, an associated teacher/teaching assistant and a facilitator teacher/teaching assistant (intervention schools only).

INTERVENTION: Schools randomised to the intervention arm delivered 12 weekly sessions of LEGO® based therapy, which promotes collaborative play and encourages social problem-solving in groups of three children and young people with a facilitator (trained teacher or teaching assistant). Participants received usual support from school and community services. Participants in the control arm received usual support only. Research assistants and statisticians were blind to treatment allocation.

MAIN OUTCOME MEASURE: The social skills subscale of the Social Skills Improvement System (SSIS), completed by the children and young people’s unblinded teacher pre randomisation and 20 weeks post randomisation. The SSIS social skills subscale measures social skills including social communication, co-operation, empathy, assertion, responsibility and self-control. Participants completed a number of other pre- and post-randomisation measures of emotional health, quality of life, loneliness, problem behaviours, academic competence, service resource utilisation and adverse events.

RESULTS: A total of 250 children and young people from 98 schools were randomised: 127 to the intervention arm and 123 to the control arm. Intention-to-treat analysis of the main outcome measure showed a modest positive difference of 3.74 points (95% confidence interval -0.16 to 7.63 points, standardised effect size 0.18; p = 0.06) in favour of the intervention arm. Statistical significance increased in per-protocol analysis, with a modest positive difference (standardised effect size 0.21; p = 0.036). Cost-effectiveness of the intervention was found in reduced service use costs and a small increase in quality-adjusted life-years. Intervention fidelity and acceptability were positive. No intervention-related adverse events or effects were reported.

CONCLUSIONS: The primary and pre-planned sensitivity analysis of the primary outcome consistently showed a positive clinical difference, with modest standardised effect sizes of between 0.15 and 0.21. There were positive health economics and qualitative findings, corroborated by the difference between arms for the majority of secondary outcomes, which were not statistically significant but favoured the intervention arm. Post hoc additional analysis was exploratory and was not used in drawing this conclusion. Given the small positive change, LEGO® based therapy for children and young people with autism spectrum disorder in schools should be considered.

LIMITATIONS: The primary outcome measure was completed by an unblinded teacher (rather than by the facilitator).

FUTURE WORK: The study team recommends future research into LEGO® based therapy, particularly in school environments.

TRIAL REGISTRATION: This trial is registered as ISRCTN64852382.

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 15/49/32) and is published in full in Public Health Research; Vol. 11, No. 12. See the NIHR Funding and Awards website for further award information.

PMID:38095124 | DOI:10.3310/VGTR7431

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Nevin Manimala Statistics

Metabolic syndrome risk among adolescents in the Deep South and the relationships with behavioral health, food insecurity, and physical activity

J Spec Pediatr Nurs. 2023 Dec 14:e12420. doi: 10.1111/jspn.12420. Online ahead of print.

ABSTRACT

PURPOSE: A combination of physical and psychosocial risk factors put adolescents at risk for poor cardiometabolic health and chronic disease burden, often recognized as metabolic syndrome. The purposes of this study were to (1) identify the prevalence of metabolic syndrome risk among adolescents, utilizing the metabolic syndrome severity index, and (2) determine the relationship between metabolic syndrome risk and behavioral health, food insecurity, and physical inactivity among adolescents.

METHODS AND DESIGN: A cross-sectional, descriptive, correlational design was deployed in an inner-city high school in the Deep South. An 8-month recruitment and enrollment period yielded a sample of 55 adolescents. A battery of measures included assessment of demographic data, anthropometric, cardiovascular, and psychosocial data. Utilizing these data elements, a progressive methodological approach was used to identify metabolic severity risk as a continuous variable for use in the adolescent population.

RESULTS: All participants identified as African American/Black. Among them, 71% (N = 39) were female and an average age of 16 (SD = 1.3) years old, with 67.3% (N = 37) of the sample at risk for metabolic syndrome. There was not a statistically significant relationship between metabolic syndrome severity score and behavioral health risk, food insecurity, and physical inactivity in this sample.

PRACTICE IMPLICATIONS: Future use of the continuous metabolic syndrome severity score may guide practice by utilizing longitudinal data to assess the trends of metabolic syndrome severity scores in relation to disease outcomes in adolescents. This may promote the identification of psychosocial and physical interrelationships with metabolic syndrome, thus improving overall health through the development of age-appropriate interventions.

PMID:38095121 | DOI:10.1111/jspn.12420

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Causal Association of Iron Status With Functional Outcome After Ischemic Stroke

Stroke. 2023 Dec 14. doi: 10.1161/STROKEAHA.123.044930. Online ahead of print.

ABSTRACT

BACKGROUND: Iron status has been associated with functional outcomes after ischemic stroke (IS). Nonetheless, this association may be affected by confounders. We perform Mendelian randomization to clarify the causal association between iron status and functional outcome after IS.

METHODS: We obtained summary-level statistics related to iron status biomarkers from a meta-analysis of a gene-wide association study conducted by the Genetics of Iron Status Consortium, which included 11 discovery cohorts and 8 replication cohorts. We also took genetic variants related to 4 biomarkers of iron status from combining gene-wide association study results of Iceland, the United Kingdom, and Denmark to perform a replicate Mendelian randomization analysis. This data set included 4 iron status biomarkers, namely, ferritin, total iron binding capacity, iron, and transferrin saturation (TSAT). The confounders in these data sets have been adjusted to mitigate the collider bias. We acquired summary statistics data sets for functional outcomes following IS from the gene-wide association study meta-analysis conducted by the Genetics of Ischemic Stroke Functional Outcome Consortium. The genetic estimates for functional outcomes at 90 days after IS were evaluated by the modified Rankin Scale score, including 3741 cases with good functional outcomes (modified Rankin Scale score, 0-2) and 2280 subjects with poor functional outcomes post-stroke (modified Rankin Scale score, 3-6). Inverse variance weighting was used as the primary method, complemented by sensitivity analyses for pleiotropy and increasing robustness.

RESULTS: Reported with odds ratios (ORs) of stroke outcome with per SD unit increase in genetically determined iron status biomarker, TSAT and iron were associated with poor functional outcome after IS (TSAT: OR, 1.36 [95% CI, 1.23-1.50]; P=2.27×109; iron: OR, 1.44 [95% CI, 1.13-1.85]; P=0.0033). In replicate Mendelian randomization analysis, the detrimental effects of iron on poor functional outcome after IS remained stable (OR, 1.60 [95% CI, 1.24-2.08]; P=0.0003). In the meta-analysis, iron and TSAT were associated with poor functional outcomes after IS (TSAT: ORmeta, 1.35 [95% CI, 1.23-1.48]; iron: ORmeta, 1.51 [95% CI, 1.27-1.81]). Through sensitivity analyses and reverse Mendelian randomization analyses, we confirmed the robustness of the results.

CONCLUSIONS: Our study provides evidence suggesting a potential causal relationship between iron status and poor functional outcomes after IS. Future studies are required to illuminate the underlying mechanism.

PMID:38095120 | DOI:10.1161/STROKEAHA.123.044930

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Comparing novel virtual reality and nursing standard care on burn wound care pain in adolescents: A randomized controlled trial

J Spec Pediatr Nurs. 2023 Dec 14:e12419. doi: 10.1111/jspn.12419. Online ahead of print.

ABSTRACT

PURPOSE: This study compared the effectiveness of age-appropriate, high technology, interactive virtual reality (VR) distraction with standard care (SC) provided by the nurse on adolescents’ acute procedural pain intensity perception during burn wound care treatment in the ambulatory clinic setting.

DESIGN: This randomized controlled trial included 43 adolescents ages 10-21 from the ambulatory burn clinic of a large children’s hospital.

METHODS: Blinded study participants were randomly assigned to either VR or SC (non-significantly different, current mean burn surface area, 1.3 and 1.7, respectively) during the first burn wound care procedure in the burn clinic. Blinded research staff collected pre-procedure data including Spielberger’s State-Trait Anxiety Inventory and postprocedure wound care pain intensity using the Adolescent Pediatric Pain Tool. A total of 41 participants completed all study procedures.

RESULTS: No statistically significant difference in burn wound care procedural pain was noted between the VR and SC groups after adjusting for several factors. Pre-procedure state and trait anxiety correlated with reported pre-procedure pain. Wound care pain was found to be significantly associated with pre-wound care pain score, time from original burn to clinic burn care treatment, and length of wound care treatment. These factors accounted for approximately 45% of the variation in pain scores during wound care treatment.

PRACTICE IMPLICATIONS: VR distraction can be a useful pain management strategy but may not take the place of the unique nurse-patient relationship that occurs during clinical encounters. Tailoring pain management during burn wound care requires consideration of anxiety, time from the burn injury to the wound care procedure, length of time of the wound care procedure, and pretreatment pain level. Knowing patients’ needs, desires, and temperaments along with the specifics about the healthcare procedures are critical to formulating individualized care plans that may or may not include VR. Newer technology, such as easier-to-use, less expensive VR, may assist with translation into practice making its clinical use more routine.

PMID:38095116 | DOI:10.1111/jspn.12419

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Assessing Mailuoning injection in wound healing and thrombophlebitis management: A rat model study

Int Wound J. 2023 Dec 14. doi: 10.1111/iwj.14527. Online ahead of print.

ABSTRACT

Thrombophlebitis is the inflammatory condition characterized by obstruction of one or more vessels, commonly in the legs, due to the formation of blood clots. It has been reported that traditional Chinese medicine, including Mailuoning injection, is advantageous for treating inflammatory and blood disorders. This research assessed the therapeutic efficacy of Mailuoning injection in the treatment of thrombophlebitis in rodents, as well as investigated its impact on fibrinolysis, inflammation, and coagulation. An experimental setup for thrombophlebitis was established in rodents via modified ligation technique. Five groups comprised the animals: sham operation group, model group, and three Mailuoning treatment groups (low, medium, and high dosages). The pain response, edema, coagulation parameters (PT, APTT, TT, FIB), serum inflammatory markers (IL-6, TNF-α, CRP), and expression levels of endothelial markers (ICAM-1, VCAM-1, NF-κB) were evaluated. Blood flow and vascular function were further assessed by measuring hemorheological parameters and the concentrations of TXB2, ET, and 6-k-PGF1α. In contrast to the sham group, model group demonstrated statistically significant increases in endothelial expression levels, coagulation latencies, and inflammatory markers (p < 0.05). The administration of mailing, specifically at high and medium dosages, resulted in a substantial reduction in inflammatory markers, enhancement of coagulation parameters, suppression of ICAM-1 and VCAM-1 expression, and restoration of hemorheological measurements to baseline (p < 0.05). Significantly higher concentrations of 6-k-PGF1α and lower levels of TXB2 and ET were observed in high-dose group, suggesting that pro- and anti-thrombotic factors were restored to equilibrium. Utilization of Mailuoning injection in rat model of thrombophlebitis exhibited significant therapeutic impact. This effect was manifested through pain alleviation, diminished inflammation, enhanced blood viscosity and facilitation of fibrinolysis. The study indicated that Mailuoning injection may serve as a viable therapeutic option for thrombophlebitis, potentially aiding in the improvement of wound healing by virtue of its anti-inflammatory and blood flow-enhancing characteristics.

PMID:38095110 | DOI:10.1111/iwj.14527

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Modeling basal body temperature data using horseshoe process regression

Stat Med. 2023 Dec 14. doi: 10.1002/sim.9991. Online ahead of print.

ABSTRACT

Biomedical data often exhibit jumps or abrupt changes. For example, women’s basal body temperature may jump at ovulation, menstruation, implantation, and miscarriage. These sudden changes make these data challenging to model: many methods will oversmooth the sharp changes or overfit in response to measurement error. We develop horseshoe process regression (HPR) to address this problem. We define a horseshoe process as a stochastic process in which each increment is horseshoe-distributed. We use the horseshoe process as a nonparametric Bayesian prior for modeling a potentially nonlinear association between an outcome and its continuous predictor, which we implement via Stan and in the R package HPR. We provide guidance and extensions to advance HPR’s use in applied practice: we introduce a Bayesian imputation scheme to allow for interpolation at unobserved values of the predictor within the HPR; include additional covariates via a partial linear model framework; and allow for monotonicity constraints. We find that HPR performs well when fitting functions that have sharp changes. We apply HPR to model women’s basal body temperatures over the course of the menstrual cycle.

PMID:38095078 | DOI:10.1002/sim.9991

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Nevin Manimala Statistics

Effect of gestational weight gain in a cohort of pregnancy women with obesity operated and not operated for bariatric surgery

Nutr Hosp. 2023 Sep 27. doi: 10.20960/nh.04639. Online ahead of print.

ABSTRACT

OBJECTIVE: to determine the effect of gestational weight gain and perinatal outcomes in obese women who underwent and did not undergo bariatric surgery.

MATERIAL AND METHODS: a retrospective observational cohort study was conducted. The gestational weight gain was classified as insufficient, adequate or excessive according to the guidelines of the United States Institute of Medicine: 4.99-9.07 kg for body mass index (BMI) > 30 kg/m2. Weight gain was calculated as the difference between the weight at the first visit of the 1st trimester and the weight at the visit of the 3rd trimester. Outcomes examined included antepartum variables (gestational diabetes, gestational hypertension, preeclampsia, premature rupture of membranes, placenta previa, placental abruption, intrauterine growth retardation, chorioammionitis, spontaneous abortion), intrapartum variables (induced delivery, vaginal delivery, vacuum, forceps delivery, cesarean section, shoulder dystocia), postpartum variables (postpartum hemorrhage, need for postpartum transfusion, postpartum anemia, need for emergency care, maternal death, postpartum tear, postpartum thrombosis) and neonatal variables (preterm delivery, weight percentile > 90, weight percentile < 10, Apgar score < 7, malformations). Using the statistical package SPSS 22.0, a statistical analysis of the data was performed.

RESULTS: two hundred and fifty-six women were recruited; 38 (14.58 %) were pregnant after bariatric surgery and 218 (85.15 %) were pregnant women with obesity who had not been operated on. Of the pregnant women with obesity who had not been operated on, 119 (46.68 %) had grade 1 obesity (BMI 30-34.9), and 99 (38.67 %) had grade 2 and 3 obesity (BMI > 35). A global and subgroup analysis was performed. In the overall analysis, 78 (30.46 %) had insufficient gain, 117 (45.70 %) had adequate gain, and 61 (23.82 %) excessive gain. Overall, insufficient weight gain was associated with a lower probability of gestational hypertension (p < 0.015) and forceps delivery (p < 0.000) and large for gestational age newborn (p < 0.000). On the other hand, insufficient weight gain was associated with a higher probability of intrauterine growth retardation (p 0.044), peripartum infection (0.022), preterm delivery (0.006), and delivery < 35 weeks (p 0.016). Excessive weight gain was associated with a higher probability of gestational hypertension (p 0.025), induced labor (p 0.009), forceps delivery (p 0.011) and large for gestational age newborn (p 0.006). Pregnancies after bariatric surgery had fewer overall complications compared to the other groups.

CONCLUSIONS: insufficient and excessive weight gain worsens perinatal outcomes. Adequate weight gain does not increase complications and produces some benefits.

PMID:38095073 | DOI:10.20960/nh.04639

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Leptin and adiposity measures from birth to later childhood: Findings from the Hyperglycemia and Adverse Pregnancy Outcomes Follow-Up Study

Pediatr Obes. 2023 Dec 14:e13087. doi: 10.1111/ijpo.13087. Online ahead of print.

ABSTRACT

BACKGROUND: Cord blood (CB) leptin is positively associated with adiposity at birth, but the association with child adiposity is unclear.

OBJECTIVES: We hypothesized that CB leptin is positively associated with adiposity in peripubertal children and with childhood leptin.

METHODS: Leptin was measured in 986 CB and 931 childhood stored samples from a prospective birth cohort. Adiposity measures were collected at birth and mean age 11.5 years. Linear and logistic regression analyses were used to evaluate associations between log-transformed CB leptin and neonatal and childhood adiposity measures as continuous and categorical variables, respectively.

RESULTS: CB leptin was positively associated with neonatal and childhood adiposity. Childhood associations were attenuated when adjusted for maternal body mass index (BMI) and glucose, but remained statistically significant for childhood body fat percentage (β = 1.15%, confidence interval [CI] = 0.46-1.84), body fat mass (β = 0.69 kg, 95% CI = 0.16-1.23), sum of skin-folds (β = 1.77 mm, 95% CI = 0.31-3.24), log-transformed child serum leptin (β = 0.13, 95% CI = 0.06-0.20), overweight/obesity (OR = 1.21, 95% CI = 1.03-1.42), obesity (OR = 1.31, 95% CI = 1.04-1.66) and body fat percentage >85th percentile (OR = 1.38, 95% CI = 1.12-1.73). Positive associations between newborn adiposity measures and CB leptin confirmed previous reports.

CONCLUSION: CB leptin is positively associated with neonatal and childhood adiposity and child leptin levels, independent of maternal BMI and maternal hyperglycemia. CB leptin may be a biomarker of future adiposity risk.

PMID:38095062 | DOI:10.1111/ijpo.13087

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Unveiling breast cancer risk profiles: a survival clustering analysis empowered by an online web application

Future Oncol. 2023 Dec 14. doi: 10.2217/fon-2023-0736. Online ahead of print.

ABSTRACT

Aim: To develop a shiny app for doctors to investigate breast cancer treatments through a new approach by incorporating unsupervised clustering and survival information. Materials & methods: Analysis is based on the Molecular Taxonomy of Breast Cancer International Consortium (METABRIC) dataset, which contains 1726 subjects and 22 variables. Cox regression was used to identify survival risk factors for K-means clustering. Logrank tests and C-statistics were compared across different cluster numbers and Kaplan-Meier plots were presented. Results & conclusion: Our study fills an existing void by introducing a unique combination of unsupervised learning techniques and survival information on the clinician side, demonstrating the potential of survival clustering as a valuable tool in uncovering hidden structures based on distinct risk profiles.

PMID:38095059 | DOI:10.2217/fon-2023-0736