Tag: statistics

PLoS One. 2021 Sep 23;16(9):e0255952. doi: 10.1371/journal.pone.0255952. eCollection 2021.

ABSTRACT

BACKGROUND: The effect of vegan diets on metabolic processes in the body is still controversial in ultra endurance athletes. The study aims to determine gut microbiome adaptation to extreme exercise according to vegan or omnivore diet consumed in ultra-marathoners. We also seek to evaluate long-term vegan diets’ effects on redox homeostasis, and muscle fatigue, and assess energy availability.

METHODS: Seventy participants will be assigned to the study, including 35 vegan ultra-marathoners and 35 omnivores competing in the Sri-Chinmoy ultra marathon race. Research data will be collected from the participants at four steps (three visits to the research laboratory and the race day) throughout the study. At the first visit (seven days before the race), fecal samples, and anthropometric measurements will be collected. Body composition will be measured using DXA. Participants will be informed about keeping detailed food records and will be asked to record their diet data and activity logs during the entire study period. At second visit, maximum oxygen consumption will be measured on treadmill. On race day, blood samples will be collected immediately before, and 0. min, 2 hours, and 24 hours after the race. Body weight will be measured before and after the race. The blood and fecal samples will be stored at -80 C until analysis. Plasma malondialdehyde, reactive oxygen metabolites, total antioxidant capacity, Heatshockprotein-70, and serum Orosomucoid-1 will be analyzed in blood samples. Fecal samples will be analyzed with shotgun metagenomic analysis and interpreted using bioinformatics pipeline (HumanN2). Statistical tests will be analyzed using SPSS version 23.0 and R Software.

DISCUSSION: Study findings will determine the effects of the vegan diet on sports performance, revealing the multiple interactions between host and gut microbiome at the whole metagenomic level. Additionally, results will show the possible adaptation throughout the race by analyzing blood and fecal samples. Furthermore, by assessing energy availability and determining host-metabolite crosstalk for ultra-endurance athletes, possible nutritional deficiencies can be identified. Thus, advanced nutritional strategies can be developed based on metabolic needs.

TRIAL REGISTRATION: Current controlled trials, ISRCTN registry 69541705. Registered on 8 December 2019.

PMID:34555041 | DOI:10.1371/journal.pone.0255952

PLoS One. 2021 Sep 23;16(9):e0257535. doi: 10.1371/journal.pone.0257535. eCollection 2021.

ABSTRACT

Effect sizes are commonly interpreted using heuristics established by Cohen (e.g., small: r = .1, medium r = .3, large r = .5), despite mounting evidence that these guidelines are mis-calibrated to the effects typically found in psychological research. This study’s aims were to 1) describe the distribution of effect sizes across multiple instruments, 2) consider factors qualifying the effect size distribution, and 3) identify examples as benchmarks for various effect sizes. For aim one, effect size distributions were illustrated from a large, diverse sample of 9/10-year-old children. This was done by conducting Pearson’s correlations among 161 variables representing constructs from all questionnaires and tasks from the Adolescent Brain and Cognitive Development Study® baseline data. To achieve aim two, factors qualifying this distribution were tested by comparing the distributions of effect size among various modifications of the aim one analyses. These modified analytic strategies included comparisons of effect size distributions for different types of variables, for analyses using statistical thresholds, and for analyses using several covariate strategies. In aim one analyses, the median in-sample effect size was .03, and values at the first and third quartiles were .01 and .07. In aim two analyses, effects were smaller for associations across instruments, content domains, and reporters, as well as when covarying for sociodemographic factors. Effect sizes were larger when thresholding for statistical significance. In analyses intended to mimic conditions used in “real-world” analysis of ABCD data, the median in-sample effect size was .05, and values at the first and third quartiles were .03 and .09. To achieve aim three, examples for varying effect sizes are reported from the ABCD dataset as benchmarks for future work in the dataset. In summary, this report finds that empirically determined effect sizes from a notably large dataset are smaller than would be expected based on existing heuristics.

PMID:34555056 | DOI:10.1371/journal.pone.0257535

Transl Psychiatry. 2021 Sep 22;11(1):486. doi: 10.1038/s41398-021-01583-5.

ABSTRACT

Structural variation in the complement 4 gene (C4) confers genetic risk for schizophrenia. The variation includes numbers of the increased C4A copy number, which predicts increased C4A mRNA expression. C4-anaphylatoxin (C4-ana) is a C4 protein fragment released upon C4 protein activation that has the potential to change the blood-brain barrier (BBB). We hypothesized that elevated plasma levels of C4-ana occur in individuals with schizophrenia (iSCZ). Blood was collected from 15 iSCZ with illness duration < 5 years and from 14 healthy controls (HC). Plasma C4-ana was measured by radioimmunoassay. Other complement activation products C3-ana, C5-ana, and terminal complement complex (TCC) were also measured. Digital-droplet PCR was used to determine C4 gene structural variation state. Recombinant C4-ana was added to primary brain endothelial cells (BEC) and permeability was measured in vitro. C4-ana concentration was elevated in plasma from iSCZ compared to HC (mean = 654 ± 16 ng/mL, 557 ± 94 respectively, p = 0.01). The patients also carried more copies of the C4AL gene and demonstrated a positive correlation between plasma C4-ana concentrations and C4A gene copy number. Furthermore, C4-ana increased the permeability of a monolayer of BEC in vitro. Our findings are consistent with a specific role for C4A protein in schizophrenia and raise the possibility that its activation product, C4-ana, increases BBB permeability. Exploratory analyses suggest the novel hypothesis that the relationship between C4-ana levels and C4A gene copy number could also be altered in iSCZ, suggesting an interaction with unknown genetic and/or environmental risk factors.

PMID:34552056 | DOI:10.1038/s41398-021-01583-5

Pol Przegl Chir. 2021 Jun 25;93(5):1-5. doi: 10.5604/01.3001.0014.9759.

ABSTRACT

OBJECTIVE: The aim of this study was to compare the post-operative effects of closed incision negative pressure wound therapy with conventional dressing in emergency laparotomy.

METHODS: This study was conducted from 1st November 2018 to 31st March 2020 in ABVIMS &amp; Dr. R.M.L. Hospital, New Delhi. The potential candidates for the study were patients of 18 years and above who were admitted in surgical emergency and underwent emergency laparotomy by a midline incision. Fifty random patients were alternatively allotted to group A (25 patients) and group B (25 patients). In the patients of group A, closed incision negative pressure wound therapy (ciNPWT) was applied on midline closed wound after an exploratory laparotomy procedure. The patients in group B, standard dry gauze dressing was done.

RESULTS: The mean age of patients in group A and group B were 46.76±12.20 and 41.96±8.33 years, respectively (p-value-0.11). The wound infection was present in 12% of cases in group A and 32% in group B, but when we calculate the p-value, it was found to be statistically non-significant (p-value-0.08). Similarly, seroma formation and wound dehiscence were found less in group A as compared to group B but not reached up to a statistically significant limit (p-value 0.55 and 0.38 respectively). The frequency of dressing change was 1-2 per week in 92% of cases in group A while it was 3-4 per week in 68% of cases in group B. The mean time of the frequency of dressing change was 1.24±0.72 per week and 4.28±1.90 per week in both the groups respectively (p-value &lt;0.001). There was no significant (p&gt;0.05) difference in the duration of hospital stay between group A (mean hospital stay 8.20±2.34 days) and group B (mean hospital stay 8.21±3.37 days).

CONCLUSION: Closed incision negative pressure wound therapy has no advantages over conventional dressing in terms of post-operative complications and hospital stay. However, it reduces the frequency of dressing change significantly, which reduces the mental stress of the patient and the burden of changing daily dressing.

PMID:34552028 | DOI:10.5604/01.3001.0014.9759

Otolaryngol Pol. 2021 May 12;75(5):16-23. doi: 10.5604/01.3001.0014.8779.

ABSTRACT

Voice dysfunction is the most common complication of thyroid surgery. The use of intraoperative neuromonitoring (IONM) is to protect the recurrent laryngeal nerves, the damage of which causes voice dysfunction. The aim of the study was to evaluate voice quality in patients who underwent complete thyroidectomy operated on with the application of IONM as well as a group of patients operated on with only macroscopic nerve visualization. In the analysis, clinical voice assessment was performed with particular focus on voice efficiency using the Voice Handicap Index (VHI), Vocal Tract Discomfort (VTD) and GRBAS scale. The study group consisted of 205 patients operated on with IONM. The control group consisted of 162 patients subjected to surgery only with macroscopic visualization of recurrent laryngeal nerves, without IONM. During the follow-up period from 2 to 10 years after surgery, checkups were performed. Each patient who came for a checkup was subjected to perceptual voice evaluation with the use of the GRBAS scale, indirect laryngoscopy procedure and voice selfevaluation with two questionnaires (VHI and VTD). The frequency of vocal fold palsy did not differ significantly statistically in the study group and the control group. Both in the study group and in the control group, patients with vocal fold paralysis had statistically significantly higher results in the VHI and VTD questionnaires as well as in the GRBAS study. Patients with recurrent laryngeal nerve injury show significant differences in the scope of voice handicap, both in the voice quality assessment with the use of the GRBAS scale, and self-evaluation questionnaires: VHI and VTD. All voice disorders evaluated with self-assessment are medium voice disability.

PMID:34552022 | DOI:10.5604/01.3001.0014.8779

Pol Przegl Chir. 2021 Jun 23;93(5):1-5. doi: 10.5604/01.3001.0014.9658.

ABSTRACT

Objectives The diagnosis of deep venous thrombosis (DVT) is hampered in patients with primary varicose veins due to similarity of symptoms of DVT and PVV and elevated levels of D-dimers. The purpose of this study was to analyze factors that influence the D-dimer concentration in patients with PVV in order to redefine its diagnostic value. Methods Forty- one patients with non-complicated PVV were enrolled in the study, in whom D-dimer level was determined by immunoturbidimetric assay. The influence of selected clinical factors on the concentration of D-dimers was determined with univariate and bivariate analysis. Besides descriptive statistics the D-dimers levels were compared to the age -adjusted cutoff values. Results The median concentration of D-dimer was 630.0 ng/ml (440.0-1140.0 ng/ml) and was above the age-adjusted level in 21 (52%) of patients. There was a positive correlation between the patient’s age and and D-dimer concentration (p = 0.035, Spearman correlation coefficient rs=0,33. The bivariate analysis showed a significant interaction between age and weight p=0,02. Conclusions In patients with PVV the diagnostic value of D-dimers is limited especially in older and overweight subjects.

PMID:34552026 | DOI:10.5604/01.3001.0014.9658

BMJ Open. 2021 Sep 22;11(9):e052871. doi: 10.1136/bmjopen-2021-052871.

ABSTRACT

A wave of new treatments and treatment combinations are becoming available for solid tumours. Trials performed to obtain registration establish a positive benefit-risk but unavoidably leave many questions unanswered on place-in-therapy and the relative efficacy of different treatment sequences. Such limitations create problems in terms of strength of treatment guidelines and reimbursement (in countries where a public payer exists). Data on new drugs arriving during the last 10 years for the treatment of hepatocellular carcinoma and renal cancer are reported as an example of how the fortunate condition of having new effective treatments may translate into uncertainty regarding the optimal treatment plan. We suggest that academic research should react to such limitations and propose a model of patient-journey study (PJS), where patients are followed from the initial diagnosis across subsequent lines of treatment. A PJS master protocol might include at each node of clinical decision either the possibility of choosing treatment according to guidelines (generating prospective real-world evidence) or the possibility to randomise where uncertainty exists (generating comparative effectiveness data). PJS protocols might be adaptively modified every time a new drug arrives on the market. Overall, methodologically sound analyses of PJS will produce knowledge on the efficacy and the effectiveness of different treatment pathways and might significantly optimise treatment of patients in clinical practice. PJS would represent a jump from a few snapshots (trials performed to get regulatory approval) to a full movie (evidence on the relative value of treatment pathways).

PMID:34551954 | DOI:10.1136/bmjopen-2021-052871

Otolaryngol Pol. 2021 May 12;75(5):1-8. doi: 10.5604/01.3001.0014.8759.

ABSTRACT

Radiotherapy (RT) for patients with head and neck squamous cell carcinoma (HNSCC) affects vital functions related to the irradiation volume of the head and neck region and, in addition, has a negative impact on social functioning, thereby significantly impairing patients’ quality of life (QoL). The aim of this study was to assess changes in the quality of life in patients with head and neck cancer treated with curative RT at 12 months after completion of RT. The aim of this study was to assess the differences between the baseline QoL of patients with early clinical stage HNSCC and at 12 months after curative/radical RT. The prospective clinical study included 92 patients in good general condition (ECOG 0-1 – Eastern Cooperative Oncology Group performance status), without regional or distant metastases, diagnosed with pathomorphologically confirmed early-stage head and neck squamous cell carcinoma treated with definitive RT. All patients participating in the study signed an informed consent form. QoL was assessed using the standard EORTC QLQ-C30 and QLQH&amp;N35 questionnaires. In addition, information on clinical aspects and data relating to socio-demographic factors were obtained from each patient. Statistical analysis was performed using a statistical package (SPSS 17.0). T-test was used for dependent and independent samples. A general linear model was used for repeated measures. Patients’ QoL deteriorated significantly after definitive RT. Worse QoL Core-30 scores in patients 12 months after the end of RT, compared with baseline QoL, before the start of RT, were observed in domains such as physical performance, fulfillment of life roles, cognitive functioning, loss of appetite, fatigue and constipation. For the QLQ-H&amp;N35 questionnaires, patients 12 months after the end of RT reported problems in relation to aspects of life such as senses, mouth opening, dry mouth, thick saliva, pain, and weight loss. RT, even in early clinical stage head and neck cancer, has a negative impact on QoL, despite modern treatment techniques.

PMID:34552020 | DOI:10.5604/01.3001.0014.8759

Int J Spine Surg. 2021 Sep 22:8123. doi: 10.14444/8123. Online ahead of print.

ABSTRACT

BACKGROUND: The frequency and complexity of spinal surgery performed in an ambulatory surgery center (ASC) is increasing. However, safety and efficacy data of most spinal procedures adapted to the ASC are sparse and have focused on anterior cervical surgery. The purpose of this study was to compare the 90-day complication and readmission rates of anterior lumbar spine surgery performed in an ASC or inpatient setting.

METHODS: We performed a retrospective comparative analysis of 226 consecutive anterior lumbar surgeries (283 levels treated) completed in an ASC (n = 124) or in an inpatient tertiary care hospital (n = 102) over a 3-year period. These included anterior lumbar interbody fusion (ALIF), artificial disc replacement (ADR), and hybrids. Patients undergoing simultaneous or staged posterior procedures within 3 months were excluded. Patient demographics and surgical parameters between the two surgical settings were compared. Ninety-day medical complications and readmission rates were assessed. One-way analysis of variance and Chi-square analysis were used. A P value of less than .05 was considered statistically significant.

RESULTS: The two study groups had similar baseline characteristics. While there was a trend toward fewer complications, reoperations, and readmissions for the ASC cohort, the differences were not statistically significant. There were 7 intraoperative complications (5.6% minor vascular injury) in the inpatient cohort and 0 in the ASC cohort. The overall 90-day postoperative complication rate was 5.6% for the inpatient cohort and 0.9% for the ASC cohort. The 90-day readmission rate was 1.9% in the ASC cohort and 1.6% in the inpatient cohort. The 90-day reoperation rate was 0.8% for the inpatient cohort and 0% in the ASC cohort. The average hospital stay was 2.3 ± 1.5 days for the inpatient cohort.

CONCLUSION: The 90-day readmission rates were lower for outpatients than for inpatients, while the complication and reoperation rates were similar. Our results demonstrate that anterior lumbar procedures, including single-level and multilevel ALIF, ADR, and hybrid procedures, can be performed safely in an ASC. This has significant cost savings implications for the ASC setting.

PMID:34551930 | DOI:10.14444/8123

BMJ Open. 2021 Sep 22;11(9):e049452. doi: 10.1136/bmjopen-2021-049452.

ABSTRACT

INTRODUCTION: Adolescents represent one of the most underserved population groups among people living with HIV. With successes in the elimination of mother to child transmission initiatives and advances in paediatric HIV treatment programmes, a large population of HIV-infected children are surviving into adolescence. Adolescence presents unique challenges that increase the risk of non-suppressed viral loads in adolescents living with HIV (ALHIV). There is a need to develop, implement and test interventions to improve viral suppression among ALHIV. Systematic reviews of recent studies present scarce and inconclusive evidence of effectiveness of current interventions, especially for adolescents. This protocol provides a description of a planned review of interventions to improve treatment outcomes among unsuppressed ALHIV.

METHODS AND ANALYSIS: A comprehensive search string will be used to search six bibliographic databases: PubMed/MEDLINE, Sabinet, EBSCOhost, CINAHL, Scopus and ScienceDirect, for relevant studies published between 2010 and 2020 globally, and grey literature. Identified articles will be exported into Mendeley Reference Management software and two independent reviewers will screen the titles, abstracts and full texts for eligibility. A third reviewer will resolve any discrepancies between the two initial reviewers. Studies reporting on interventions to improve viral suppression, retention and adherence for adolescents will be considered for inclusion. The systematic review will be performed and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Where feasible, a meta-analysis will be conducted using Stata Statistical Software: Release V.16. The quality of the studies and risk of bias will be assessed using the Critical Appraisal Skills Programme checklists and Risk of Bias in Non-randomised Studies of Interventions tool, respectively.

ETHICS AND DISSEMINATION: The systematic review entails abstracting and reviewing already publicly available data rather than any involvement of participants, therefore, no ethical clearance will be required. Results will be shared with relevant policy-makers, programme managers and service providers, and published and share through conferences and webinars.

PROSPERO REGISTRATION NUMBER: CRD42021232440.

PMID:34551946 | DOI:10.1136/bmjopen-2021-049452