Category: Statistics

Anticancer Res. 2023 Jun;43(6):2671-2681. doi: 10.21873/anticanres.16433.

ABSTRACT

BACKGROUND/AIM: The role of single nucleotide polymorphisms (SNPs) in the frequency and intensity of chemotherapy-induced nausea and vomiting (CINV) in women with breast cancer (BC) is unclear. The primary purpose of this study was to compare/evaluate the effect of SNP-guided antiemetic treatment versus standard CINV treatment.

PATIENTS AND METHODS: A randomised, factorial, phase II multicentre study design was used. Women planned for neoadjuvant or adjuvant chemotherapy with epirubicin, cyclophosphamide and fluorouracil (FEC /EC, with or without fluorouracil) for BC were randomised to SNP-guided antiemetic treatment (based on the results of SNP analyses) versus standard CINV treatment. Blood samples were taken before the treatment was initiated. Patient-reported data on CINV (during 10 days from onset of cancer treatment) and health-related quality of life (HRQoL), were collected before and after the first cancer treatment.

RESULTS: A total of 188 women were included. Overall, nausea was reported by 86% (n=129) of the patients during the ten-day period from the start of cancer treatment. The SNP genotype studied varied. In FAS-CD95, the genotypes AG and GG were overrepresented; in RB1-LPAR6, GG was overrepresented, and in CCL2, both AA and GG were overrepresented. We found no statistically significant difference in CINV between SNP-guided antiemetic treatment versus standard CINV treatment.

CONCLUSION: SNP-guided antiemetic treatment could be as effective as standard treatment. SNP-guided antiemetic treatment of CINV is possibly useful in detecting patients with a higher or lower risk for CINV and thus may help in avoiding over-treatment with toxic components. CINV negatively affects the HRQL.

PMID:37247895 | DOI:10.21873/anticanres.16433

Med J Aust. 2023 May 29. doi: 10.5694/mja2.51978. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the impact of the 2009 National Reform Program for organ donation in Australia on the number and characteristics of organ donors under 16 years of age.

DESIGN, SETTING, PARTICIPANTS: Retrospective observational time series study; analysis of Australia and New Zealand Organ Donation (ANZOD) registry data for all consented potential deceased organ donors under 16 years of age during 2000-2019, and of numbers of donors aged 16 years or more reported in ANZOD annual reports.

MAIN OUTCOME MEASURES: Difference between 2000-2008 (pre-reform) and 2009-2019 (reform period) in annual organ donor rates (donors per million population), by age group (under 16 years, 16 years or more), reported as incidence rate ratio (IRR).

SECONDARY OUTCOMES: Differences in child donor characteristics during 2000-2008 and 2009-2019.

RESULTS: During 2000-2019, 400 children under 16 years of age were consented potential deceased organ donors, of whom 374 were actual deceased donors (94%): 146 during 2000-2008, 228 during 2009-2019. The median annual rate was 3.3 (interquartile range [IQR], 3.0-4.3) actual donors per million population during 2000-2008 and 4.2 (IQR, 3.6-5.2) donors per million population during 2009-2019 (IRR, 1.15; 95% confidence interval [CI], 0.93-1.42). In contrast, the difference between the two periods was statistically significant for donors aged 16 years or more, rising from 11.7 (IQR, 11.2-11.8) to 19.9 (IQR, 18.3-24.4) actual donors per million population (IRR, 1.75; 95% CI, 1.66-1.85). The median age of actual organ donors under 16 was similar during 2000-2008 (11 years; IQR, 7-14 years) and 2009-2019 (10 years; IQR, 4-14 years), as was the proportion of donors in this age group under 10 kg (2000-2008: four of 146, 3%; 2009-2019: 14 of 228, 6%).

CONCLUSIONS: Despite its overall effect on organ donation rates, the National Reform Program was not effective in increasing the numbers of donors under 16 years of age. Relying on broad initiatives for adult donors may not be appropriate for achieving this aim.

PMID:37247848 | DOI:10.5694/mja2.51978

J Am Coll Radiol. 2023 May 27:S1546-1440(23)00390-3. doi: 10.1016/j.jacr.2023.02.033. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the efficacy of a multi-modal intervention in reducing CT pulmonary angiography (CTPA) overutilization in the evaluation of suspected pulmonary embolism (PE) in the emergency department (ED).

METHODS: Previous mixed methods analysis of barriers to guideline-concordant CTPA ordering results was used to develop a provider focused behavioral intervention consisting of a clinical decision support tool and an audit and feedback system at a multi-site, tertiary academic network. The primary outcome (guideline concordance), and secondary outcomes (yield, and CTPA and D-dimer order rates), were compared using a pre-intervention/post intervention design. ED encounters for adult patients from 7/5/2017 to 1/3/2019 were included. Fisher’s exact tests and statistical process control (SPC) charts were used to compare the pre-/post-intervention groups for each outcome.

RESULTS: Of the 201,912 ED patient visits evaluated, 3,587 included CTPA. Guideline concordance increased significantly after the intervention, from 66.9% to 77.5% (p<0.001). CTPA order rate and D-dimer order rate also increased significantly, from 17.1 to 18.4 per 1000 patients, p=0.035, and 30.6 to 37.3 per 1000 patients, p<0.001, respectively. Percent yield showed no significant change (12.3% pre- vs.10.8% post-intervention; p=0.173). SPC analysis showed sustained special-cause variation in the post-intervention period for guideline concordance and D-dimer order rates, temporary special-cause variation for CTPA order rates, and no special-cause variation for percent yield.

CONCLUSION: Our success in increasing guideline concordance demonstrates the efficacy of a mixed methods, human-centered approach to behavior change. Given that neither of the secondary outcomes improved, our results may demonstrate potential limitations to the guidelines directing the ordering of CTPA studies and/or D-dimer ordering.

PMID:37247831 | DOI:10.1016/j.jacr.2023.02.033

Gen Comp Endocrinol. 2023 May 27:114322. doi: 10.1016/j.ygcen.2023.114322. Online ahead of print.

ABSTRACT

Predation or brood parasitism risks can change the behaviors and reproductive decisions in many parental animals. For oviparous species, mothers can mitigate their reproductive success in at least three ways: (1) by avoiding nest sites with high predation or parasitism risks, (2) through hormonal maternal effects that developmentally prime offspring for survival in risky environments, or (3) by investing less in reproduction when predation or parasitism risks are high. Here, we tested if perceived predation and parasitism risks can induce any of these behavioral or physiological responses by exposing female red-winged blackbirds (Agelaius phoeniceus) to playbacks of two major nest threats, a predator (Cooper’s hawk, Accipiter cooperii) and an obligate brood parasite (brown-headed cowbird; Molothrus ater), as well as two controls (harmless Eastern meadowlark, Sturnella magna; and silence). We found that female blackbirds did not avoid nesting at sites treated with predator or brood parasite playbacks, nor were females more likely to abandon nesting attempts at these sites. Egg size and yolk hormone profiles, which are common proxies for maternal investment in oviparous species, were statistically similar across treatment sites. Instead, we found intraclutch variation in yolk steroid hormone profiles: concentrations of three progestogens (pregnanedione, 17α-hydroxypregnenolone, and deoxycorticosterone) and two androgens (testosterone and androstenedione) were higher in third-laid than first-laid eggs. Our study largely confirms previous findings of consistent intraclutch yolk hormone variation in this species, in birds in general, and in other oviparous lineages, but uniquely reports on several yolk steroid hormones largely overlooked in the literature on hormone-mediated maternal effects.

PMID:37247827 | DOI:10.1016/j.ygcen.2023.114322

J Nutr. 2023 May 27:S0022-3166(23)72117-2. doi: 10.1016/j.tjnut.2023.05.024. Online ahead of print.

ABSTRACT

BACKGROUND: Adding carotenoids, particularly lutein (L) and zeaxanthin (Z), to prenatal micronutrient formulations has been promoted to enhance infant visual and neural development and to maintain maternal health. Although these claims are biologically plausible, they are not yet supported by a compelling prospective trial.

OBJECTIVE: We investigated the effect of prenatal carotenoid supplementation on biomarkers of maternal and infant systemic carotenoid status.

METHODS: We randomly assigned 47 first trimester pregnant subjects by 1:1 allocation to receive standard-of-care prenatal vitamins plus a 10 mg L and 2 mg Z softgel (Carotenoid Group) or standard-of-care prenatal vitamins with a placebo softgel (Control Group) for 6 to 8 months. Maternal carotenoid concentrations in the serum and skin at the end of each trimester and postpartum were measured with high-performance liquid chromatography and resonance Raman spectroscopy, respectively. Infants’ systemic carotenoid status was assessed using similar techniques but optimized for infants. Repeated measures and paired t-tests were determined, and a p-value <0.05 was considered statistically significant.

RESULTS: Following supplementation, there was a statistically significant increase in maternal serum L+Z concentrations, serum total carotenoid concentrations, and skin carotenoid status (p < 0.001, for all) in the Carotenoid Group relative to the Control Group at all study time points. Similarly, infants whose mothers were in the Carotenoid Group had a significant 5-fold increase in cord blood L+Z concentrations, over a 3-fold increase in cord blood total carotenoids, and a 38% increase in skin carotenoids compared to the Control Group (p < 0.0001, for all). Also, there was a strong positive, statistically significant correlation between postpartum maternal and infants’ systemic carotenoid status (p < 0.0001).

CONCLUSION: Prenatal carotenoid supplementation significantly increased maternal and infant systemic (skin and serum) carotenoid status, which may benefit pregnant women and their babies’ health.

PMID:37247819 | DOI:10.1016/j.tjnut.2023.05.024

J Affect Disord. 2023 May 27:S0165-0327(23)00732-2. doi: 10.1016/j.jad.2023.05.087. Online ahead of print.

ABSTRACT

BACKGROUND: It has been suggested that gender differences in anxiety and depressive symptoms characterize panic disorder (PD) in terms of vulnerability to stressful life events, anxiety, depressive symptom patterns, and brain structure. However, few studies have investigated the gender differences in PD using a network approach.

METHODS: This study included 619 participants with PD (313 men). The Panic Disorder Severity Scale, Albany Panic and Phobia Questionnaire, and Beck Depression Inventory-II were used to evaluate symptomatology. To investigate the PD-related white matter (WM) neural correlates, tract-based spatial statistics were used. The PD-related clinical scales and WM neural correlates were included in the network analysis to identify associations between variables. To evaluate network differences between genders, network comparison tests were conducted.

RESULTS: Our findings revealed that agoraphobia in men was the strongest central symptom. In addition, loss of pleasure, and not anxiety or panic symptoms, was the strongest central symptom in women with PD. The network comparison test revealed that the bridge strength score was higher in agoraphobia and tiredness in men and in self-criticalness in women. Furthermore, in the network that includes neural correlates of WM, the bridge strength score was higher in the cingulate gyrus WM in men and the cingulum hippocampus in women.

LIMITATIONS: Since this is a cross-sectional network study of PD patients, the causal relationship between interactions in this network analysis for both genders may not be accurately determined.

CONCLUSION: Network structures of anxiety and depressive symptomatology and related WM neural correlates can differ according to gender in PD patients.

PMID:37247787 | DOI:10.1016/j.jad.2023.05.087

J Affect Disord. 2023 May 27:S0165-0327(23)00727-9. doi: 10.1016/j.jad.2023.05.082. Online ahead of print.

ABSTRACT

BACKGROUND: The voice has been thought to be associated with emotions, but conducting large-scale research on this relationship has some limitations. To overcome these limitations, questionnaires have been utilized as a research tool.

METHODS: A population-based cross-sectional study was done. A total of 15,977 participants completed questionnaires regarding self-recognition of voice disorder (SRVD), and mental health status.

RESULTS: 1053(6.6 %) participants answered that they had SRVD. In the multivariate Cox proportional hazard model, psychological stress (Hazard ratio (HR) = 1.371, 95 % confidence interval (CI) = 1.154-1.629), depressive symptoms (HR = 1.626, 95 % CI = 1.323-1.997), suicidal ideation (HR = 1.739, 95 % CI = 1.418-2.133), and suicide attempt (HR =2.206, 95 % CI = 1.067-4.56) were all associated with SRVD. In SRVD lasting over three weeks, psychological stress (HR = 1.604, 95 % CI = 1.278-2.014), depressive symptoms (HR = 1.807, 95 % CI = 1.384-2.36), and suicidal ideation (HR = 2.073, 95 % CI = 1.587-2.709) were also significant factors. As the number of mental health problems increased, the odds ratio of both SRVD (OR = 2.49, 95 % CI = 1.839-3.37) and SRVD lasting over three weeks (OR = 3.254, 95 % CI = 2.242-4.725) increased, respectively.

LIMITATIONS: SRVD and mental health status were judged only by simple questionnaires. Cross-sectional design and retrospective data could not draw causal relationships.

CONCLUSIONS: SRVD and SRVD lasting over three weeks had a significant relationship with mental health status, including psychological stress, depressive symptoms, and suicidal ideation. There is a need to consider psychiatric treatment for individuals who visit hospitals with voice disorders.

PMID:37247786 | DOI:10.1016/j.jad.2023.05.082

J Shoulder Elbow Surg. 2023 May 27:S1058-2746(23)00395-6. doi: 10.1016/j.jse.2023.04.018. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of this study was to perform a systematic review and meta-analysis of studies comparing local injections of either platelet-rich plasma (PRP) or corticosteroid for the treatment of lateral elbow epicondylitis.

METHODS: A systematic review of Medline, Embase, Scopus, and Google Scholar was performed, and all level 1 and 2 randomized studies from 2000 to 2022 were included. Clinical symptoms, patient perceived outcomes, and pain were assessed by the DASH (disabilities of the arm, shoulder and hand questionnaire) and pain by the VAS (visual analog scale). Publication bias and risk of bias were assessed using the Cochrane Collaboration’s tools. The modified Coleman Methodology Score (CMS) and the GRADE system were used to assess the quality of the body of evidence. Heterogeneity was assessed using χ² and I² statistics.

RESULTS: Thirteen studies were included in the analysis. Five studies had a high risk of bias, and the risk of bias across studies was assessed as unclear. There was no publication bias identified. Two of the four GRADE domains (inconsistency of results, imprecision of results) were downgraded to low quality, and the final GRADE assessment was downgraded to a low quality of evidence. The mean CMS score was 62.8, indicating fair quality. The pooled estimate for VAS at 1 month favored corticosteroids (p=0.75), but favored PRP at three (p=0.003) and six months (p=0.0001). The pooled estimate for the DASH score favored corticosteroids at 1 month (p=0.028), but favored PRP at three (p=0.01) and six months (p=0.107) CONCLUSION: The results of this meta-analysis suggest that PRP has no advantage over steroid injections within the first month of treatment, but that it is superior to steroids at both 3 and 6 months. These results also suggest that corticosteroids have a short-term beneficial effect during the early treatment period, although the quality of the available evidence is not very robust in support of this finding. However, these findings must all be viewed with caution as the high risk of bias and moderate to low quality of the included studies may not justify a recommendation of one treatment over another.

PMID:37247780 | DOI:10.1016/j.jse.2023.04.018

Cytokine. 2023 May 27;168:156231. doi: 10.1016/j.cyto.2023.156231. Online ahead of print.

ABSTRACT

BACKGROUND: Burn injury is a sudden and traumatic injury that affects a large part of the population worldwide, who are placed at high risk of developing hypertrophic scars (HTS). HTS are a fibrotic scar resulting in painful contracted and raised scarring, affecting mobility in joints and work life, as well as cosmetically. The aim of this research was to enhance our understanding of the systematic response of monocytes and cytokines in wound healing after burn injury, in order to develop novel approaches to prevention and treatment of HTS.

METHODS: Twenty-seven burn patients and thirteen healthy individuals were recruited in this study. Burn patients were stratified by burn total body surface area (TBSA). Peripheral blood samples were taken post-burn injury. Serum and peripheral blood mononuclear cells (PBMCs) were separated from the blood samples. This research investigated cytokines IL-6, IL-8, IL1RA, IL-10, and chemokine pathways SDF-1/CXCR4, MCP-1/CCR2, RANTES/CCR5 during the wound healing process in burn patients with varying severity of injuries by using enzyme-linked immunosorbent assays. PBMCs were stained for monocytes and the chemokine receptors by flow cytometry. Statistical analysis was done by one-way ANOVA with a Tukey correction, and regression analysis was performed using Pearson’s Correlation analysis.

RESULTS: The CD14⁺CD16^– monocyte subpopulation is larger in patients who developed HTS at 4-7 days. The CD14⁺CD16⁺ monocyte subpopulation is smaller in the first week of injury, where it is similar after 8 days. Burn injury increased CXCR4, CCR2, and CCR5 expressions in CD14⁺ CD16⁺ monocytes. Increases in MCP-1 at 0-3 days after burn injury was positively correlated with burn severity. IL-6, IL-8, RANTES, and MCP-1 significantly increased with increasing burn severity.

CONCLUSIONS: Monocytes and their chemokine receptors, as well as systemic levels of cytokines in wound healing of burn patients and scar development will require ongoing assessment to enhance our understanding of the abnormal wound healing after burn injury.

PMID:37247448 | DOI:10.1016/j.cyto.2023.156231