Genetic Determination of Coagulation Factor VIIc Levels among Healthy Middle-aged Women

1995 ◽  
Vol 73 (04) ◽  
pp. 623-625 ◽  
Author(s):  
Elaine Meilahn ◽  
Robert Ferrell ◽  
Joseph Kiss ◽  
Anne Temple ◽  
Fiona Green ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Statistical Significance ◽  
Geometric Mean ◽  
Coagulation Factor ◽  
Small Sample ◽  
Clotting Factor ◽  
Genetic Determination ◽  
Chd Risk ◽  
Hormone Use ◽  
The One

SummaryA recent study (1) reported variation among men in clotting factor Vile levels is associated with a genetic polymorphism detected by the restriction enzyme Msp I. The present study determined the Msp I genotype (Arg353, Gln353 alleles) for 189 women (mean age 53) who were subjects in the Healthy Women Study, a population study of CHD risk factor change at menopause. Women with the Arg/Arg genotype (n = 147) had an 16% higher (geometric) mean FVIIc level than those with the Arg/Gln (n = 41) genotype (1.21 vs 1.04 U/ml, p<0.01), while the one subject with the Gln/Gln genotype had an FVIIc level of 1.00 U/ml. These results are consistent with those previously found in healthy men (1). In addition, women carrying the Gin allele did not exhibit the elevation in FVIIc with menopause and use of hormone therapy found among those with the Arg allele, suggesting that genotype may modify the observed rise in factor Vile at menopause. Possibly because of the small sample size this interaction did not reach conventional levels of statistical significance. Results of multiple linear regression analyses controlling for age, hormone use, obesity, (In) triglyceride levels, and family history of CHD found FVIIc levels to be significantly (p<0.001) related to genotype. Thus, genotype appears to be a major determinant of FVIIc levels among women.

Combination of AST to ALT and neutrophils to lymphocytes ratios as predictors of locally advanced disease in patients with bladder cancer subjected to radical cystectomy: Results from a single-institutional series

2021 ◽  
pp. 039156032110351
Author(s):  
Alessandro Uleri ◽  
Rodolfo Hurle ◽  
Roberto Contieri ◽  
Pietro Diana ◽  
Nicolòmaria Buffi ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Advanced Disease ◽  
Independent Predictor ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Small Sample ◽  
Locally Advanced Disease ◽  
Increased Risk

Background: Bladder cancer (BC) staging is challenging. There is an important need for available and affordable predictors to assess, in combination with imaging, the presence of locally-advanced disease. Objective: To determine the role of the De Ritis ratio (DRR) and neutrophils to lymphocytes ratio (NLR) in the prediction of locally-advanced disease defined as the presence of extravescical extension (pT ⩾ 3) and/or lymph node metastases (LNM) in patients with BC treated with radical cystectomy (RC). Methods: We retrospectively analyzed clinical and pathological data of 139 consecutive patients who underwent RC at our institution. Logistic regression models (LRMs) were fitted to test the above-mentioned outcomes. Results: A total of 139 consecutive patients underwent RC at our institution. Eighty-six (61.9%) patients had a locally-advanced disease. NLR (2.53 and 3.07; p = 0.005) and DRR (1 and 1.17; p = 0.01) were significantly higher in patients with locally-advanced disease as compared to organ-confined disease. In multivariable LRMs, an increasing DRR was an independent predictor of locally-advanced disease (OR = 3.91; 95% CI: 1.282–11.916; p = 0.017). Similarly, an increasing NLR was independently related to presence of locally-advanced disease (OR = 1.28; 95% CI: 1.027–1.591; p = 0.028). In univariate LRMs, patients with DRR > 1.21 had a higher risk of locally advanced disease (OR = 2.83; 95% CI: 1.312–6.128; p = 0.008). Similarly, in patients with NLR > 3.47 there was an increased risk of locally advanced disease (OR = 3.02; 95% CI: 1.374–6.651; p = 0.006). In multivariable LRMs, a DRR > 1.21 was an independent predictor of locally advanced disease (OR = 2.66; 95% CI: 1.12–6.35; p = 0.027). Similarly, an NLR > 3.47 was independently related to presence of locally advanced disease (OR = 2.24; 95% CI: 0.95–5.25; p = 0.065). No other covariates such as gender, BMI, neoadjuvant chemotherapy or diabetes reached statistical significance. The AUC of the multivariate LRM to assess the risk of locally advanced disease was 0.707 (95% CI: 0.623–0.795). Limitations include the retrospective nature of the study and the relatively small sample size.

Internet-based intervention compared to brief intervention for smoking cessation in Brazil: a pilot study (Preprint)

2021 ◽  
Author(s):  
Nathalia Machado ◽  
Henrique Gomide ◽  
Heder Bernardino ◽  
Telmo Ronzani
Keyword(s):  
Smoking Cessation ◽  
Brief Intervention ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Healthcare Providers ◽  
Intervention Group ◽  
Small Sample ◽  
The Internet ◽  
Intention To Treat ◽  
Internet Based Intervention

BACKGROUND Smoking is still the leading cause of preventable death. Governments and healthcare providers should make available more and accessible resources to help tobacco users stop. OBJECTIVE This study describes a pilot longitudinal study that evaluated the efficacy of a computerized intervention compared to the brief intervention for smoking cessation among Brazilians. METHODS Smokers were recruited and randomly assigned to one of the two intervention groups. RESULTS The results showed similar rates of cessation and reduction for both intervention groups. The internet-based intervention was a little more effective for smoking cessation, while the brief intervention was more effective in reducing the number of cigarettes smoked per day. Despite this, this difference was small and had no statistical significance even after adjusting for intention-to-treat analysis. These results should be interpreted with caution, especially due to the small sample size. CONCLUSIONS Forty-nine smokers were enrolled in this study (25 in the brief intervention group; 24 in the internet-based intervention group). The mean age was 44.46 years old; most were male (59.2%), had elementary school (44.9%), smoked an average of 14.5 cigarettes per day, had a mean score of 4.65 for nicotine dependence, and score of 5.7 for motivation to quit. Measures were drawn from comparing cessation rate, motivation score and sought treatment between groups. Thirty-five participants answered the follow up 1 and 19 answered to the second.

scholarly journals Systematic Review and Meta-Analysis of Linezolid and Daptomycin for Treatment of Vancomycin-Resistant Enterococcal Bloodstream Infections

2013 ◽  
Vol 57 (10) ◽  
pp. 5013-5018 ◽  
Author(s):  
Donald W. Whang ◽  
Loren G. Miller ◽  
Neil M. Partain ◽  
James A. McKinnell
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Bloodstream Infections ◽  
Small Sample ◽  
Antibiotic Selection ◽  
Vancomycin Resistant

ABSTRACTBloodstream infections due to vancomycin-resistant enterococci (VRE-BSI) result in substantial patient mortality and cost. Daptomycin and linezolid are commonly prescribed for VRE-BSI, but there are no clinical trials to determine optimal antibiotic selection. We conducted a systematic review for investigations that compared daptomycin and linezolid for VRE-BSI. We searched Medline from 1966 through 2012 for comparisons of linezolid and daptomycin for VRE-BSI. We included searches of EMBASE, clinicaltrials.gov, and national meetings. Data were extracted using a standardized instrument. Pooled odds ratios (OR) and 95% confidence intervals (95% CI) were calculated using a fixed-effects model. Our search yielded 4,243 publications, of which 482 contained data on VRE treatment. Most studies (452/482) did not present data on BSI or did not provide information on linezolid or daptomycin. Among the remaining 30 studies, 9 offered comparative data between the two agents. None were randomized clinical trials. There was no difference in microbiologic (n= 5 studies, 517 patients; OR, 1.0; 95% CI, 0.4 to 1.7;P= 0.95) and clinical (n= 3 studies, 357 patients; OR, 1.2; 95% CI, 0.7 to 2.0;P= 0.7) cures between the two antibiotics. There was a trend toward increased survival with linezolid compared to daptomycin treatment (n= 9 studies, 1,074 patients; OR, 1.3; 95% CI, 1.1 to 1.8;I2= 0 [whereI2is a measure of inconsistency]), but this did not reach statistical significance (P= 0.054). There are limited data to inform clinicians on optimal antibiotic selection for VRE-BSI. Available studies are limited by small sample size, lack of patient-level data, and inconsistent outcome definitions. Additional research, including randomized clinical trials, is needed before conclusions can be drawn about treatment options for VRE therapy.

Unsubstantiated conclusions about the Family Star Plus as an outcome measure: a rebuttal to Sweet, Winter, Neeson and Connolly (2020)

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Anna Good ◽  
Joy MacKeith
Keyword(s):  
Ordinal Data ◽  
Design Methodology ◽  
Outcome Measure ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Reliability And Validity ◽  
Small Sample ◽  
Content Type ◽  
Outcomes Measures ◽  
The Family

Purpose The purpose of this article is to explain why Sweet et al.'s assertions are not well founded and raise unsubstantiated doubt over the use of the Family star Plus and the Outcomes Star suite of tools as outcomes measures. Design/methodology/approach Evidence is presented of flaws in the analysis, reporting and conclusions of an article published in this journal (Sweet et al., 2020). Findings Sweet et al. failed to mention a body of Outcomes Star validation work, including over 20 online reports and a manuscript they had seen of a now published article supporting the reliability and validity of the Family Star Plus (Good and MacKeith, 2020). There are significant issues with their methodology, presentation of results and conclusions including: reliance on statistical significance with a small sample size; use of statistics not intended for ordinal data and; and inappropriate conclusions from convergence with measures conceptually different to the Family Star Plus. Originality/value Evidence is presented that the Family Star Plus is a useful and valid outcome measure and that Sweet et al.’s conclusions can be attributed to issues with their methodology and interpretation.

Three-year results of phase I retinal gene therapy trial for CNGA3-mutated achromatopsia: results of a non randomised controlled trial

2021 ◽  
pp. bjophthalmol-2021-319067
Author(s):  
Felix Friedrich Reichel ◽  
Stylianos Michalakis ◽  
Barbara Wilhelm ◽  
Ditta Zobor ◽  
Regine Muehlfriedel ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Primary Endpoint ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Small Sample ◽  
Functional Improvement ◽  
Limiting Factor ◽  
Serious Adverse Events

AimsTo determine long-term safety and efficacy outcomes of a subretinal gene therapy for CNGA3-associated achromatopsia. We present data from an open-label, nonrandomised controlled trial (NCT02610582).MethodsDetails of the study design have been previously described. Briefly, nine patients were treated in three escalating dose groups with subretinal AAV8.CNGA3 gene therapy between November 2015 and October 2016. After the first year, patients were seen on a yearly basis. Safety assessment constituted the primary endpoint. On a secondary level, multiple functional tests were carried out to determine efficacy of the therapy.ResultsNo adverse or serious adverse events deemed related to the study drug occurred after year 1. Safety of the therapy, as the primary endpoint of this trial, can, therefore, be confirmed. The functional benefits that were noted in the treated eye at year 1 were persistent throughout the following visits at years 2 and 3. While functional improvement in the treated eye reached statistical significance for some secondary endpoints, for most endpoints, this was not the case when the treated eye was compared with the untreated fellow eye.ConclusionThe results demonstrate a very good safety profile of the therapy even at the highest dose administered. The small sample size limits the statistical power of efficacy analyses. However, trial results inform on the most promising design and endpoints for future clinical trials. Such trials have to determine whether treatment of younger patients results in greater functional gains by avoiding amblyopia as a potential limiting factor.

scholarly journals Library orientation practices in special libraries

2020 ◽  
Vol 48 (4) ◽  
pp. 525-536
Author(s):  
Melissa Fraser-Arnott
Keyword(s):  
Information Needs ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Academic Library ◽  
Small Sample ◽  
Orientation Program ◽  
Content Type ◽  
Special Library ◽  
Library Staff ◽  
Host Organization

Purpose The library orientation session is an important marketing tool because it offers the first opportunity for library staff to connect with new clients (Craft and Ballard-Thrower, 2011; Rhoades and Hartsell, 2008). This paper aims to explore library orientation practices in special libraries and information centers with the goal of surveying current practices and identifying guidance for successful orientation program design and delivery. Design/methodology/approach This study explored library orientation practices in special libraries and information services through an electronic survey. The survey questions were developed based on themes that emerged from case studies on library orientations from the academic library literature. These themes included reasons for library orientation program redesigns, the importance of partnerships in orientation design and delivery and the tools and techniques used in the delivery of orientation sessions. Findings The results revealed that library orientations are taking place in special libraries, but there is no consistent approach to library orientation delivery. Even within a single library, multiple approaches to library orientations are taken based on client availability, demand and information needs observations of library staff. Participants’ responses were analyzed to develop recommendations for special library orientations. These include developing partnerships (particularly with human resource departments), using technology strategically, considering the timing of orientations for new potential clients in relation to their start as new employees in the host organization, customizing library orientations based on client segment, engaging in ongoing outreach, and being flexible in design and delivery methods. Research limitations/implications This study represents a starting step in an exploration of library orientation practices in special libraries. The key limitation of this study was the low response rate leading to small sample size. A larger sample of special libraries would be needed to produce a quantitative analysis of the prevalence of practices with an acceptable degree of statistical significance. Alternately, smaller samples of special libraries organized by characteristics such as size or type (e.g. corporate libraries, law libraries and medical libraries) could be conducted to determine if distinctive trends exist within these special library types. Practical implications This study revealed information about key practices and challenges that can be used by special library practitioners seeking to implement or redesign a library orientation program in their library. Originality/value While academic and practitioner literature exists detailing library orientation activities in academic and school libraries, there are very few papers on special library orientations. This study fills a gap in the literature by investigating library orientation practices in special libraries and information centers.

scholarly journals Coronavirus disease-2019 in cancer patients. A report of the first 25 cancer patients in a western country (Italy)

2020 ◽  
Vol 16 (20) ◽  
pp. 1425-1432 ◽  
Author(s):  
Elisa Maria Stroppa ◽  
Ilaria Toscani ◽  
Chiara Citterio ◽  
Elisa Anselmi ◽  
Elena Zaffignani ◽  
...  
Keyword(s):  
Sample Size ◽  
Antiviral Therapy ◽  
Cancer Patients ◽  
General Hospital ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Western Country ◽  
Small Sample ◽  
Control Group ◽  
Worse Prognosis

Background: We describe cancer patients with coronavirus disease-2019 (COVID-19) infection treated at the Piacenza’s general hospital (north Italy). Materials & methods: 25 cancer patients infected by COVID-19 admitted at the Piacenza’s general hospital from 21 February to 18 March 2020. Outcome from the infection were compared with infected noncancer patients. Results: 20 patients (80%) were treated with antiviral therapy and hydroxychloroquine and five (20%) received hydroxychloroquine alone. Nine (36%) patients died, while 16 (64%) overcome the infection. In the control group the mortality was 16.13% and the overcome from infection was 83.87%. Conclusion: Mortality for COVID-19 was greater in cancer patients when compared with noncancer patients, worse prognosis for older age, women and patients treated with hydroxychloroquine alone. However, the comparisons did not reach statistical significance in most cases. This could be due to the small sample size that is the main limitation of the study.

A Comparison of Three Methods of Repairing the Hard Palate

2002 ◽  
Vol 39 (4) ◽  
pp. 383-391 ◽  
Author(s):  
R. W. Pigott ◽  
E. H. Albery ◽  
I. S. Hathorn ◽  
N. E. Atack ◽  
A. Williams ◽  
...  
Keyword(s):  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Small Sample ◽  
Velopharyngeal Insufficiency ◽  
Strong Trend ◽  
Computer Based ◽  
Palate Repair

Objective To compare growth, speech, and nasal symmetry outcomes of three methods of hard palate repair. Patients Consecutive available records of children born with unilateral bony complete cleft lip and palate over the period 1972 to 1992. Interventions Identical management of lip, nose, alveolus, and soft palate. Hard palate repair by Cuthbert Veau (CV) from 1972 to 1981, von Langenbeck (vL) from 1982 to 1989, or medial Langenbeck (ML) from 1989 to 1991. Outcome Measures For growth: GOSLON yardstick or 5-year model index. For speech: articulation test. Nasal anemometry. For nasal symmetry: Coghlan computer-based assessment. All these measures were developed during the period of data collection but not for this project. Results There was a strong trend toward more favorable anteroposterior maxillary growth with the change from CV to vL to ML techniques. This fell short of statistical significance because of the small sample size. There was a significant reduction in cleft-related articulation faults (p = .01) considered to be related to improved arch form. In the absence of improved rates of velopharyngeal insufficiency or nasal symmetry, increased surgical experience was discounted as a significant contribution to improved growth and articulation outcomes. Conclusions Reduced periosteal undermining and residual exposed palatal shelf from CV to vL to ML improved incisor relationships and articulation.

Evaluation of the relationship between patient factors and the reduction in clearance of pegylated liposomal doxorubicin

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2548-2548
Author(s):  
N. M. La-Beck ◽  
B. A. Zamboni ◽  
D. Tzemach ◽  
H. Schmeeda ◽  
R. Sapir ◽  
...  
Keyword(s):  
Body Weight ◽  
Liposomal Doxorubicin ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Pegylated Liposomal Doxorubicin ◽  
Ideal Body Weight ◽  
Total Body Weight ◽  
Subsequent Treatment ◽  
Small Sample ◽  
Monocyte Count

2548 Background: The reticuloendothelial system (RES), which includes monocytes, may have a key role in clearance (CL) of nanoparticle sized pegylated liposomes. However, the factors affecting the CL of liposomes are unclear. Age, body composition, and monocyte count have been related to CL of liposomal agents (Zamboni, ASCO '07; Maruca, ASCO '07; Sidone, AACR- NCI-EORTC '07). The CL of pegylated liposomal doxorubicin (PLD) decreases significantly from cycle 1 to 3 (Gabizon, Cancer Chemother Pharmacol 2008). The objectives of this study were to evaluate factors associated with decreases in PLD CL. Methods: Patients (pts) with various solid tumors were randomized to PLD administered IV every 28 days at 30, 60 and 45 mg/m2 (n = 6) or 60, 30 and 45 mg/m2 (n = 6) on cycles 1, 2 and 3 respectively. Serial plasma samples for PLD pharmacokinetic (PK) analysis were obtained prior to and at 1 h, 24 h, 72 to 96 h, 7 d, 14 d, 21 d, and 28 d after PLD infusion on cycles 1, 2, and 3. Samples were processed to measure sum total (encapsulated + released) doxorubicin by HPLC with fluorescence. PLD CL was calculated by noncompartmental methods. Precycle monocyte count, age, and ratio of total body weight to ideal body weight were compared to PLD CL. Results: Mean + SD PLD CL on cycles 1 and 3 were 23.7 + 7.7 mL/h and 16.4 + 5.4 mL/h, (P < 0.0001). Pts with a reduction as compared with an increase in precycle monocyte count from cycle 1 to 3 had a mean + SD change in PLD CL of -11.5 + -3.5 mL/h and -5.3 + -3.0 mL/h, respectively (P = 0.09). Median age was 61 years old (yo). Pts > 61 yo and < 61 yo had a mean + SD change in PLD CL from cycles 1 to 3 of - 8.7 + -4.3 mL/h and -5.2 + -5.4 mL/h, respectively (P = 0.16). Conclusions: PLD CL decreased significantly from cycle 1 to 3. Decreased precycle monocyte count was associated with a larger decrease in PLD CL compared to increased monocyte count. Pts > 61 yo had a larger decrease in CL compared to pts < 61 yo. These results suggest monocytes are involved in the CL of PLD and that older pts may have less RES reserve and thus may be more likely to have a larger decrease in PLD CL with subsequent treatment cycles. Statistical significance was not met due to small sample size; however, further investigation of the association between changes in PLD CL and patient age and monocyte count is warranted. [Table: see text]

scholarly journals Randomized Controlled Trial of Strain-Specific Probiotic Formulation (Renadyl) in Dialysis Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Ranganathan Natarajan ◽  
Bohdan Pechenyak ◽  
Usha Vyas ◽  
Pari Ranganathan ◽  
Alan Weinberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Venous Blood ◽  
Small Sample ◽  
Uremic Toxin ◽  
Double Blind

Background. Primary goal of this randomized, double-blind, placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins. Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress.Methods. Two 2-month treatment periods separated by 2-month washout and crossover, with physical examinations, venous blood testing, and quality of life questionnaires completed at each visit. Data were analyzed with SAS V9.2.Results. 22 subjects (79%) completed the study. Observed trends were as follows (none reaching statistical significance): decline in WBC count(-0.51×109/L,P=0.057)and reductions in levels of C-reactive protein(-8.61 mg/L,P=0.071)and total indoxyl glucuronide(-0.11 mg%,P=0.058). No statistically significant changes were observed in other uremic toxin levels or measures of QOL.Conclusions. Renadyl appeared to be safe to administer to ESRD patients on hemodialysis. Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease. Efficacy could not be confirmed definitively, primarily due to small sample size and low statistical power—further studies are warranted.

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