Relationship between fatigue and cytokine levels in patients age 50+ with acute myeloid leukemia (AML)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19566-19566
Author(s):  
A. Panju ◽  
D. Kelvin ◽  
M. D. Minden ◽  
S. M. Alibhai
Keyword(s):  
Small Sample Size ◽  
Statistical Significance ◽  
Best Supportive Care ◽  
Small Sample ◽  
Published Data ◽  
European Organization ◽  
Effective Prevention ◽  
Time Points ◽  
Markers Of Inflammation ◽  
Cytokine Levels

19566 Background: Fatigue is the most common and disabling symptom affecting patients with AML; effective prevention or treatment measures have yet to be found. Cytokines, biological markers of inflammation, may represent a major cause of fatigue, but published data are limited. Methods: Patients age 50 or older with AML were recruited between May and September 2006. All patients were fluent in English, within one year of diagnosis, and free of any other active malignancy. Fatigue was measured using the Functional Assessment of Cancer Therapy (FACT) Fatigue subscale, a single-item global fatigue scale, and the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30. Blood was simultaneously drawn for quantitative measurement of a panel of 13 cytokines. Repeat measurements were done 4–6 weeks later. Correlational analysis was used to examine relationships between individual cytokines and fatigue scores. Changes in fatigue scores between time points were correlated with changes in cytokine levels. Results: 34 patients (23 men; 11 women) were enrolled (mean age 67 y; range 52–84). 27% had not started chemotherapy or were receiving best supportive care, while the rest were undergoing active chemotherapy. At baseline, a weak correlation (r=0.332, p=0.059) was seen with interleukin (IL)-6 and at least one fatigue measure. No correlations (r<0.30) were observed with any of the other cytokines (interferon (IFN)-?, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IP-10, MCP-1, MiG, and tumor necrosis factor-a) and any fatigue measure. Follow-up data were available for 29 patients. A statistically significant correlation with fatigue was seen with IL-2 (r=0.407, p=0.032), and clinically-important correlations that did not achieve conventional statistical significance were seen with IFN-? (r=0.331, p=0.085), IL-5 (r=0.344, p=0.073), and IL-10 (r=0.326, p=0.091). Conclusions: Based on these data, the most promising cytokine-fatigue relationship was noted with IL-2. However, IFN-?, IL-5, IL-6, and IL-10 also showed potentially important relationships with fatigue. Given our small sample size and patient enrolment at differing time points during their treatment course, further controlled studies are warranted. No significant financial relationships to disclose.

Relationship between Fatigue and Cytokine Levels in Patients Age 50+ with Acute Myeloid Leukemia (AML).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4507-4507
Author(s):  
Abbas H. Panju ◽  
David Kelvin ◽  
Mark D. Minden ◽  
Shabbir M.H. Alibhai
Keyword(s):  
Small Sample Size ◽  
Depression Scale ◽  
Small Sample ◽  
The Other ◽  
Strong Correlations ◽  
Moderate Correlation ◽  
European Organization ◽  
Time Points ◽  
Markers Of Inflammation ◽  
Ifn Γ

Abstract Several studies have found fatigue to be the most common, persistent, and disabling symptom affecting patients with AML. Effective measures to prevent or treat fatigue have yet to be found. Cytokines, biological markers of inflammation, may represent one potential intervention target, but data on the fatigue-cytokine relationship in AML are limited to one small published study. We examined this relationship in patients age 50 or older with AML, fluent in English, within one year of AML diagnosis, and free of any other active malignancy. Fatigue was measured using the Functional Assessment of Cancer Therapy (FACT) Fatigue subscale and a single-item global fatigue scale. Quality of life (QOL) and depression were assessed using the European Organization for the Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and the Hospital Anxiety and Depression Scale (HADS), respectively. Blood was simultaneously drawn for quantitative measurement of a panel of cytokines. Patients were reassessed 4–6 weeks later, and the same set of questionnaires were administered and a second blood sample drawn. Pearson’s correlation was used to examine relationships between individual cytokines and fatigue scores. Variables were transformed as necessary. For patients with data at two time points, changes in fatigue scores were correlated with changes in cytokines. At the time of submission, 31 patients (20 males; 11 females) have been enrolled (mean age 67 y; range 52–84). 32% had not started active chemotherapy or were receiving best supportive care, while the remainder were undergoing active chemotherapy. At the first time point (t1), no moderate or strong correlations were observed with any of the cytokines and at least one fatigue score. Weak correlations (0.30<r<0.50) were seen with interleukin(IL)-5, IL-6, IL-8, and IL-10 with at least one fatigue measure. No correlations (r<0.30) were observed with any of the other cytokines tested (interferon (IFN)-γ, IL-1β, IL-2, IL-4, IL-12, interferon-inducible protein (IP)-10, monocyte chemotactic protein (MCP)-1, monokine induced by gamma-IFN (MiG), and tumour necrosis factor (TNF)-α). Among patients with follow-up data, a moderate correlation (0.50<r<0.70) was noted between changes in IL-6 level and fatigue scores. Changes in concentrations of IFN-γ, IL-1β, IL-2, IL-5, IL-8, IL-10, IP-10, and MiG showed weak correlation with changes in at least one fatigue measure. A moderate correlation was observed between age and IL-1β but no age relationship was noted for any of the other cytokines. There was no correlation between fatigue and age but there were moderate to strong correlations between fatigue and depression. Based on these data, the most consistent relationships between concentrations of cytokines and fatigue were noted with IL-5, IL-6, and IL-8, and these show the most promise for future studies. Our study bore two notable limitations: the first was the small sample size, and the second was the recruitment of patients at differing time points during their treatment course. Further patient enrolment and data collection are underway to validate our findings and clarify the significance of these preliminary results.

scholarly journals Effect of Expanded Hemodialysis with Theranova® in Patients with COVID-19

2022 ◽  
pp. 1-9
Author(s):  
María Luisa Serrano Salazar ◽  
Jose Portolés ◽  
Maria de Valdenebro Recio ◽  
Silvia Rosado Garcia ◽  
Maria del Rosario Llópez Carratalá ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Statistical Significance ◽  
Immunosuppressive Treatment ◽  
Kidney Injury ◽  
Small Sample ◽  
Control Group ◽  
Β2 Microglobulin ◽  
Cytokine Levels ◽  
To Come ◽  
And Control

<b><i>Introduction:</i></b> Cytokine storm control is the main target for improving severe COVID-19 by using immunosuppressive treatment. Effective renal replacement therapy (RRT) could give us an advantage removing cytokines in patients with RRT requirements superimposed on COVID-19. <b><i>Methods:</i></b> This is a prospective observational study in COVID-19 patients who required hemodialysis (HD). Patients were assigned to online hemodiafiltration (OL-HDF) and expanded HD (HDx) according to Brescia group recommendations. We measured several cytokines, β2 microglobulin and albumin levels pre/post-dialysis and on 1st–2nd week. We compared levels among both techniques and control group (HD without COVID-19). <b><i>Results:</i></b> We included 26 patients: 18 with COVID-19 on RRT (5 of them had acute kidney injury [AKI]) and 8 controls. We confirm higher cytokine levels in COVID-19 patients than controls and even higher in patients with AKI than in those with chronic kidney disease. Most cytokines raised during HD session, except IL-10 and TNFα. IL-10 was eliminated by any dialysis technique, while clearance of TNFα was higher in the HDx group. HDx achieved a deeper normalization of cytokines and β2 microglobulin reduction. Mortality was higher in the OL-HDF group than the HDx group. <b><i>Discussion:</i></b> Not all cytokines behave equally along HD session. The following characteristics should be taken into account, such as intrinsic kinetic profile during a HD session. HDx seems to get better performance, probably due to the combination of different factors; however, we did not reach statistical significance due to the small sample size, dropout, and reduction of AKI incidence during the 2nd pandemic wave. <b><i>Conclusion:</i></b> HDx appears to provide better clearance for TNFα and β2 microglobulin during HD session and associates lower mortality. We propose the HDx technique for COVID-19 patients with RRT requirements since it seems to be safe and more effective than OL-HDF. Further studies are still needed, but we hope that our preliminary data may help us in future pandemic waves of SARS-CoV-2 or other viruses still to come.

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.

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