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Nevin Manimala Statistics

Screening of biomarkers for prediction of multisite artery disease in patients with recent myocardial infarction

Scand J Clin Lab Invest. 2021 Aug 4:1-8. doi: 10.1080/00365513.2021.1921839. Online ahead of print.

ABSTRACT

A few studies have examined biomarkers in patients with myocardial infarction (MI) and peripheral artery disease (PAD), i.e. multisite artery disease (MSAD). The aim of the study was firstly, to associate biomarkers with the occurrence of PAD/MSAD and secondly, if those can, in addition to clinical characteristics, identify MI patients with MSAD.In two prospectively observational studies including unselected patients with recent MI, PAD was defined as an abnormal ankle-brachial index (ABI) score (<0.9 or >1.4). The proximity extension assay (PEA) technique was used, simultaneously analyzing 92 biomarkers with association to cardiovascular disease. Biomarkers were tested for univariate associations with PAD. Random forest was used to identify biomarkers with a higher association to PAD. The additional discriminatory accuracy of adding biomarkers to clinical characteristics was analyzed by the c-statistics. Nine biomarkers were identified as significantly associated with MSAD/PAD in the primary patient cohort, analyzed early after the MI. In the prediction analysis, six biomarkers were identified associated with PAD. Three of these; Tumor necrosis factor receptor (TNFR-1), Tumor necrosis factor receptor 2 (TNFR-2) and Growth Differentiation Factor 15 (GDF-15) improved c-statistics when added to clinical characteristics from 0.683 (95% CI 0.610-0.756) to 0.715 (95% CI 0.645-0.784) in the primary patient cohort with a similar result, 0.729 (95% CI 0.687-0.770) to 0.752 (95% CI 0.771-0.792) in the secondary patient cohort. Biomarkers associated with inflammatory pathways are associated with MSAD in MI patients. Three biomarkers of 92; TNFR-1, TNFR-2 and GDF-15, in this exploratory added information in the prediction of MSAD and emphasis the importance of further studies.

PMID:34346268 | DOI:10.1080/00365513.2021.1921839

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The Prosody of Two-Syllable Words in French-Speaking Monolingual and Bilingual Children: A Focus on Initial Accent and Final Accent

Lang Speech. 2021 Aug 4:238309211030312. doi: 10.1177/00238309211030312. Online ahead of print.

ABSTRACT

This study examined the acoustic characteristics of disyllabic words produced by French-speaking monolingual and bilingual children, aged 2;6 to 6;10, and by adults. Specifically, it investigated the influence of age, bilingualism, and vocabulary on final-to-initial syllable duration ratios and on the presence of initial and final accent. Children and adults took part in a word-naming task in which they produced a controlled set of disyllabic words. Duration and maximum pitch were measured for each syllable of the disyllabic word and these values were inserted into mixed-effects statistical models. Results indicated that children as young as 2;6 obtained final-to-initial syllable duration ratios similar to those of adults. Young children realized accent on the initial syllable more often and accent on the final syllable less often than older children and adults. There was no influence of bilingualism on the duration and pitch characteristics of disyllabic words. Children aged 2;6 with smaller vocabularies produced initial accent more often than children with large vocabularies. Our findings suggest that early word productions are constrained by developmental tendencies favouring falling pitch across an utterance.

PMID:34346255 | DOI:10.1177/00238309211030312

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Using Competing Risk of Mortality to Inform the Transition from Prostate Cancer Active Surveillance to Watchful Waiting

Eur Urol Focus. 2021 Jul 31:S2405-4569(21)00182-6. doi: 10.1016/j.euf.2021.07.003. Online ahead of print.

ABSTRACT

BACKGROUND: For men on active surveillance (AS) for prostate cancer (PCa), disease progression and age-related changes in health may influence decisions about pursuing curative treatment.

OBJECTIVE: To evaluate the predicted PCa and non-PCa mortality at the time of reclassification among men on AS, to identify clinical criteria for considering a transition from AS to watchful waiting (WW).

DESIGN, SETTING, AND PARTICIPANTS: Patients enrolled in a large AS program who experienced biopsy grade reclassification (Gleason grade increase) were retrospectively examined. All patients who had complete documentation of medical comorbidities at reclassification were included.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A validated model was used to assess 10- and 15-yr untreated PCa and non-PCa mortalities based on patient comorbidities and PCa clinical characteristics. We compared the ratio of predicted PCa mortality with predicted non-PCa mortality (“predicted mortality ratio”) and divided patients into four risk tiers based on this ratio: (1) tier 1 (ratio: >0.33), (2) tier 2 (ratio 0.33-0.20), (3) tier 3 (ratio 0.20-0.10), and (4) tier 4 (ratio <0.10).

RESULTS AND LIMITATIONS: Of the 344 men who were reclassified, 98 (28%) were in risk tier 1, 85 (25%) in tier 2, 93 (27%) in tier 3, and 68 (20%) in tier 4 for 10-yr mortality. Fifteen-year risk tiers were distributed similarly. The 23 (6.7%) men who met the “transition triad” (age >75 yr, Charlson Comorbidity Index >3, and grade group ≤2) had a 14-fold higher non-PCa mortality risk and a lower predicted mortality ratio than those who did not (0.07 vs 0.23, p < 0.001). The primary limitations of our study included its retrospective nature and the use of predicted mortalities.

CONCLUSIONS: At reclassification, nearly half of patients had a more than five-fold and one in five patients had a more than ten-fold higher risk of non-PCa death than patients having a risk of untreated PCa death. Despite a more significant cancer diagnosis, a transition to WW for older men with multiple comorbidities and grade group <3 PCa should be considered.

PATIENT SUMMARY: Men with favorable-risk prostate cancer and life expectancy of >10 yr are often enrolled in active surveillance, which entails delay of curative treatment until there is evidence of more aggressive disease. We examined a group of men on active surveillance who developed more aggressive disease, and found, nevertheless, that the majority of these men continued to have a dramatically higher risk of death from non-prostate cancer causes than from prostate cancer based on a risk prediction tool. For men older than 75 yr, who have multiple medical conditions and who do not have higher-grade cancer, it may be reasonable to reconsider the need for curative treatment given the low risk of death from prostate cancer compared with the risk of death from other causes.

PMID:34344628 | DOI:10.1016/j.euf.2021.07.003

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Utilising virtual environments for radiation therapy teaching and learning

J Med Imaging Radiat Sci. 2021 Jul 31:S1939-8654(21)00152-1. doi: 10.1016/j.jmir.2021.07.001. Online ahead of print.

ABSTRACT

INTRODUCTION: Modern radiation therapy undergraduate education comprises the illustration of theoretical, technical concepts in a classroom setting, coupled with the acquisition of practical handling and patient communication skills within the clinical environment. In recent years, there has been renewed interest in the application of virtual environments to education, despite ongoing inconclusive evidence on the use of virtual environments for enhancing student educational achievement.

AIM AND OBJECTIVES: The aim of our research is to evaluate a custom-built 3D virtual radiation oncology department created within Second Life®, an online virtual world, as an alternative to traditional physical classroom-based didactic instruction, in tandem with a Virtual Environment for Radiotherapy Training (VERT) system, for the peer support and training of junior radiation therapy students in their first and second year of undergraduate studies. To achieve this aim, we investigated learning achievement outcomes, knowledge retention over a 2-week time interval and learner self-perceived confidence post-instruction, using both quantitative and qualitative analysis.

METHODS: Institutional ethics approval was granted for an exempted review. Participants were currently enrolled undergraduate Year 1 and Year 2 students at our institution. Student participants were randomised into two groups; the control group attended a face-to-face classroom session centred on the illustration of theoretical, technical concepts, while the intervention group attended a virtual classroom session online on Second Life®, where similar content was delivered. Both groups then attended a VERT practical session to acquire practical handling and communication skills in radiation therapy. Upon completion of the sessions, confidence surveys, knowledge-based written and practical assessments were administered to the student participants.

RESULTS: We found that the instructional session conducted within the custom-built 3D virtual radiation oncology department in Second Life® compared to the traditional didactic classroom setting increased undergraduate Year 1 radiation therapy students’ perceived confidence to a greater extent compared to Year 2 students, in performing radiation therapy treatment procedures. In addition, our findings revealed that overall learning achievement outcomes and knowledge retention scores between Second Life® and non- Second Life® student participants were closely similar and statistically insignificant. Thematic analysis of the confidence survey questionnaires revealed that the students in general desired more clinical hands-on practice.

DISCUSSION: Second Life® is equally effective in disseminating theoretical, technical course content delivery to undergraduate radiation therapy students. The use of virtual environments appears to have increased the perceived confidence of the Year 1 undergraduate students to a greater extent compared to the Year 2 undergraduates, suggesting that the adoption of virtual environments early in the students’ educational journey can have a positive effect on students’ learning experience.

CONCLUSIONS AND RECOMMENDATIONS: The development and use of our custom-built Second Life® radiation oncology department provides a novel way of delivering remote, virtual training instruction to undergraduate radiation therapy students over traditional, didactic classroom instructional delivery. We recommend, based on the results of this pilot study, that future research can involve a larger study sample of undergraduate RT students, to explore both the short-term and long-term impact of virtual environments on student learning outcomes across their enrolled years of study. This would in turn mean progressive attempts to revamp our existing curricula structure, to deliberately incorporate the use of virtual environments, especially during early undergraduate years, towards enhanced modern RT education.

PMID:34344633 | DOI:10.1016/j.jmir.2021.07.001

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The impact of hallux valgus on function and quality of life in females

Foot Ankle Surg. 2021 Jul 26:S1268-7731(21)00155-7. doi: 10.1016/j.fas.2021.07.013. Online ahead of print.

ABSTRACT

BACKGROUND: The effect of hallux valgus (HV) on health-related quality of life (HRQOL) and the relationship between radiographic severity of deformity and patient reported outcome measures (PROMs) is poorly understood. The aim of this study was to compare the HRQOL of female patients with HV to the UK population. The secondary aim was to assess the correlation between PROMs, including HRQOL, with radiographic severity of deformity.

METHODS: Weight bearing radiographic data (hallux valgus (HVA) angle; intermetatarsal (IM) angle) were measured in consecutive female patients presenting with HV. Each patient prospectively completed the Euroqol EQ-5D-5L questionnaire (EQ-5D), Visual Analogue Scale for Pain (VAS-Pain) and Manchester Oxford Foot Questionnaire (MOXFQ). Data were stratified into age ranges and compared with an EQ-5D United Kingdom general population reference dataset. Pearson R correlation values were calculated for the PROMs and radiographic deformity.

RESULTS: Between July 2015 and March 2020, 425 consecutive female patients presented with HV for consideration for surgery. EQ-5D-5L data were prospectively collected for 396 of these patients (93.2%). Females less than 65 years with HV had a statistically significantly worse quality of life compared with females of the same age group in the general population. Above the age of 65, there was no statistically significant difference in EQ-5D-5L Index score between the two groups. Younger females reported higher VAS-Pain scores compared to older patients with 91% of patients reporting some degree of pain symptoms. There was a moderate correlation with MOXFQ Index score and EQ-5D-5L Index (R = -0.51, p < 0.001) and VAS-Pain scores (R = 0.54, p < 0.001). There was no correlation between radiographic HV deformity and HRQOL measures or MOXFQ scores although it was noted that there was a trend of increasing HVA/IMA with age.

CONCLUSION: Female patients presenting with HV deformity have a significantly reduced quality of life compared with the UK general population. The radiographic severity of deformity did not correlate with HRQOL measures or foot and ankle specific PROMs. Foot and ankle specific clinical PROMsmoderately correlate with HRQOL and may be a better marker of the negative effect of symptomatic hallux valgus deformity on quality of life.

LEVEL OF EVIDENCE: III.

PMID:34344603 | DOI:10.1016/j.fas.2021.07.013

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Effectiveness and cost-effectiveness of a people-centred care model for community-living older people versus usual care ─ A randomised controlled trial

Res Social Adm Pharm. 2021 Jul 30:S1551-7411(21)00283-7. doi: 10.1016/j.sapharm.2021.07.025. Online ahead of print.

ABSTRACT

BACKGROUND: There is a need for effective and cost-effective interprofessional care models that support older people to maintain their quality of life (QoL) and physical performance to live longer independently in their own homes.

OBJECTIVES: The objectives were to evaluate effectiveness, QoL and physical performance, and cost-utility of a people-centred care model (PCCM), including the contribution of clinically trained pharmacists, compared with that of usual care in primary care.

METHODS: A randomised controlled trial (RCT) with a two-year follow-up was conducted. The participants were multimorbid community-living older people, aged ≥75 years. The intervention comprised an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support. At the baseline and at the 1-year and 2-year follow-ups, QoL (SF-36, 36-Item Short-Form Health Survey) and physical performance (SPPB, Short Performance Physical Battery) were measured. Additionally, a physical dimension component summary in the SF-36 was calculated. The SF-36 data were transformed into SF-6D scores to calculate quality-adjusted life-years (QALYs). Healthcare resource use were collected and transformed into costs. A healthcare payer perspective was adopted. Incremental cost-effectiveness ratio (ICER) was calculated, and one-way sensitivity analysis was performed.

RESULTS: No statistically or clinically significant differences were observed between the usual care (n = 126) and intervention group (n = 151) patients in their QoL; at the 2-year follow-up the mean difference was -0.02, (95 % CI -0.07; 0.04,p = 0.56). While the mean difference between the groups in physical performance at the 2-year follow-up was -1.02, (-1.94;-0.10,p = 0.03), between the physical component summary scores it was -7.3, (-15.2; 0.6,p = 0.07). The ICER was -73 638€/QALY, hence, the developed PCCM dominated usual care, since it was more effective and less costly.

CONCLUSIONS: The cost-utility analysis showed that the PCCM including pharmacist-led medication review dominated usual care. However, it had no effect on QoL and the effect towards physical performance remained unclear.

PMID:34344607 | DOI:10.1016/j.sapharm.2021.07.025

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Early Albumin Exposure After Cardiac Surgery

J Cardiothorac Vasc Anesth. 2021 Jul 10:S1053-0770(21)00583-8. doi: 10.1053/j.jvca.2021.07.011. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine whether the early use of albumin after cardiac surgery in the first 24 hours in the intensive care unit (ICU) is associated with reduced mortality.

DESIGN: A single-center nonrandomized retrospective cohort study using the Medical Information Mart in Intensive Care IV database.

SETTING: A single cardiothoracic ICU in the United States during a period between 2008 to 2019.

PARTICIPANTS: Patients undergoing valvular and/or cardiac bypass graft surgeries.

INTERVENTIONS: Albumin administered during the first 24 hours of the ICU admission.

MEASUREMENTS AND MAIN RESULTS: A total of 8,136 patients were included in this study, of whom 4,444 (54.6%) received albumin at any stage during the first 24 hours of ICU admission, and 69 (1.6%) of those patients died. The patient population exposed to albumin had higher comorbidities and illness severity compared to the no-albumin group. Patients exposed to albumin during the first 24 hours of ICU admission had a statistically significant reduction in mortality (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.48-0.97, p < 0.05) after adjustment for age, the Oxford Acute Severity of Illness Score, and the Charlson comorbidity index. A sensitivity analysis of patients who received albumin at any stage during ICU admission showed increased mortality (OR, 1.93; 95% CI, 1.26-3.07, p < 0.01). Patients exposed to albumin had a significant increase in adjusted ICU length of stay (LOS) (geometric mean ratio 1.09; 95% CI, 1.05-1.10, p = < 0.001) and hospital LOS (geometric mean ratio 1.08; 95% CI, 1.05-1.10, p < 0.001).

CONCLUSIONS: Exposure to albumin in the first 24 hours after cardiac surgery is associated with a reduction in adjusted hospital mortality and an increase in both hospital and ICU lengths of stay.

PMID:34344597 | DOI:10.1053/j.jvca.2021.07.011

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Assessing the testicular sperm microbiome: a low-biomass site with abundant contamination

Reprod Biomed Online. 2021 Jun 29:S1472-6483(21)00305-9. doi: 10.1016/j.rbmo.2021.06.021. Online ahead of print.

ABSTRACT

RESEARCH QUESTION: The semen harbours a diverse range of microorganisms. The origin of the seminal microbes, however, has not yet been established. Do testicular spermatozoa harbour microbes and could they potentially contribute to the seminal microbiome composition?

DESIGN: The study included 24 samples, comprising a total of 307 testicular maturing spermatozoa. A high-throughput sequencing method targeting V3 and V4 regions of 16S rRNA gene was applied. A series of negative controls together with stringent in-silico decontamination methods were analysed.

RESULTS: Between 50 and 70% of all the detected bacterial reads accounted for contamination in the testicular sperm samples. After stringent decontamination, Blautia (P = 0.04), Cellulosibacter (P = 0.02), Clostridium XIVa (P = 0.01), Clostridium XIVb (P = 0.04), Clostridium XVIII (P = 0.02), Collinsella (P = 0.005), Prevotella (P = 0.04), Prolixibacter (P = 0.02), Robinsoniella (P = 0.04), and Wandonia (P = 0.04) genera demonstrated statistically significant abundance among immature spermatozoa.

CONCLUSIONS: Our results indicate that the human testicle harbours potential bacterial signature, though in a low-biomass, and could contribute to the seminal microbiome composition. Further, applying stringent decontamination methods is crucial for analysing microbiome in low-biomass site.

PMID:34344601 | DOI:10.1016/j.rbmo.2021.06.021

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Response to comments on the paper “serum uric acid is associated with incident hip fractures in women and men”

Maturitas. 2021 Jul 21:S0378-5122(21)00135-3. doi: 10.1016/j.maturitas.2021.07.008. Online ahead of print.

NO ABSTRACT

PMID:34344569 | DOI:10.1016/j.maturitas.2021.07.008

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Effects of body weight regain on leptin levels: A systematic review and meta-analysis

Cytokine. 2021 Jul 31:155647. doi: 10.1016/j.cyto.2021.155647. Online ahead of print.

ABSTRACT

BACKGROUND: There are different changes observed before and after diet therapy, and also after weight regain. However, there is not sufficient information regarding weight regain and hormonal changes.

PURPOSE: The purpose of this study was to review the connection between weight regain and leptin concentration levels.

METHODS: MEDLINE, SCOPUS, Web of Science, and the Cochrane Library were searched for interventional articles published from January 1, 1980, to June 30, 2020. Randomized clinical trials with parallel or cross over design assessing leptin concentrations at the baseline and at the end of study were reviewed. Two independent reviewers extracted data related to study design, year of publication, country, age, gender, body mass index (BMI), duration of the following up period and mean ± SD of other intended variables.

RESULTS: Four articles were included, published between 2004 and 2016. Three of them were conducted in the US and one of them in Netherland. Sample size of the studies ranged between 25 and 148 participants. The range of following up period was from13 to 48 weeks. The age range of participants was from 34 to 44 years. Our analysis shows that weight regain could reduce leptin levels, but this change is not statistically significant.

CONCLUSION: This review suggests that weight regain may induce a non-significant reduction in leptin level. However, the limited number and great heterogeneity between the included studies may affect the presented results and there are still need to well-designed, large population studies to determine the relationship between weight regain and leptin levels.

PMID:34344588 | DOI:10.1016/j.cyto.2021.155647