Psychometric evaluation of an item bank for computerized adaptive testing of the EORTC QLQ-C30 cognitive functioning dimension in cancer patients

Background The European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Group is developing computerized adaptive testing (CAT) versions of all EORTC Quality of Life Questionnaire (QLQ-C30) scales with the aim to enhance measurement precision. Here we present the results on the field-testing and psychometric evaluation of the item bank for cognitive functioning (CF). Methods In previous phases (I-III), 44 candidate items were developed measuring CF in cancer patients. In phase IV, these items were psychometrically evaluated in a large sample of international cancer patients. This evaluation included an assessment of dimensionality, fit to the item response theory (IRT) model, differential item functioning (DIF), and measurement properties. Results A total of 1030 cancer patients completed the 44 candidate items on CF. Of these, 34 items could be included in a unidimensional IRT model, showing an acceptable fit. Although several items showed DIF, these had a negligible impact on CF estimation. Measurement precision of the item bank was much higher than the two original QLQ-C30 CF items alone, across the whole continuum. Moreover, CAT measurement may on average reduce study sample sizes with about 35-40% compared to the original QLQ-C30 CF scale, without loss of power. Conclusion A CF item bank for CAT measurement consisting of 34 items was established, applicable to various cancer patients across countries. This CAT measurement system will facilitate precise and efficient assessment of HRQOL of cancer patients, without loss of comparability of results

Assessment of skin-related toxicity in patients with metastatic colorectal cancer treated with cetuximab

Monoclonal antibodies (mAbs) blocking the epidermal growth factor receptor (EGFR) pathway, such as cetuximab, have been widely used in recent years for the treatment of metastatic colorectal cancer (mCRC). The purpose of this study was to evaluate the profile of the side effects of cetuximab affecting the skin and its appendages. We gathered the medical records on skin-related toxicity in 46 patients treated with cetuximab for mCRC in the Department of Clinical Oncology, University Hospital in Krakow in 2009-2013. Skin toxicity was classified according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0. The typical side effects of cetuximab were observed. The most common skin toxicity was an acne-like skin rash (80% of patients) and paronychia (20%). Other side effects were trichomegaly, hypertrichosis, and allergic reactions.In view of high incidence of skin lesions during treatment with cetuximab, it is essential to observe patients carefully and to control the side effects during therapy. Previous experience from clinical trials shows that in some cases proper care and prevention can improve the quality of the patients’ lives.</p

Zmiany w sposobie leczenia operacyjnego wysiłkowego nietrzymania moczu u kobiet – obserwacje ostatnich dwudziestu dwóch lat

Objectives: The aim of this study was to analyze the changing trends in surgical treatment of female urinary incontinence (UI). Material and methods: Medical records of all women admitted to II Department of Gynecology from 1985 to 2006 were analyzed in order to find out how the female SUI treatment changed over these years. Results: During analyzed time 36819 patients were hospitalized in our Department and 77.6% (28568) of them were operated because of various indications. The number of SUI surgeries among all hospitalized women steadily rose from 1.93% in 1985 to 10.96% in 2006 reaching maximum in 2005 (13.73%). Clinical effectiveness of SUI surgeries markedly improved from 35% for anterior colporrhaphy to almost 90 % for suburethral slings. Conclusions: Introduction into clinical practice modern suburethral slings improved clinical efficacy of SUI treatment. The percentage of women admitted and treated surgically because of SUI steadily increased over the last years.Cel pracy: Celem pracy było przeprowadzenie retrospektywnej analizy metod operacyjnego leczenia wysiłkowego nietrzymania moczu (WNM) u kobiet na przestrzeni ostatnich dwudziestu dwóch lat. Materiał i metody: Dane do analizy pozyskano z archiwum medycznego II Kliniki Ginekologii i na ich podstawie przedstawiono zmiany w operacyjnym leczeniu WNM u kobiet od 1985 do 2006 roku. Wyniki: W analizowanym okresie, w II Klinice hospitalizowanych było 36819 kobiet, z czego 77,6% (28568) było operowanych z powodu różnych wskazań. Liczba pacjentek operowanych z powodu WNM stale rosła od 1,93% w 1985r. do 10,96% w 2006r. ze szczytem w 2005r. (13,73%). Również skuteczność zabiegów znacznie wzrosła z 35% w przypadku różnych modyfikacji plastyki przedniej ściany pochwy do niemal 90% przy zastosowaniu taśm podcewkowych. Wnioski: Wprowadzenie nowoczesnych, małoinwazyjnych taśm podcewkowych znacząco zwiększyło efektywność operacyjnego leczenia WNM. Wydaje się to być jedną z przyczyn stałego wzrostu liczby kobiet decydujących się na tą metodę leczenia tej dolegliwości

Validation of the Polish language version of the SF-36 Health Survey in patients suffering from lumbar spinal stenosis

[b]introduction and objective[/b]. Patient-reported outcome (PRO) questionnaires have become the standard measure for treatment effectiveness after spinal surgery. One of the most widely used generic PROs is the SF-36 Health Survey. The aim of this study was to specifically focus on validating the SF-36 Health Survey to confirm that the tool is an acceptable and psychometrically robust measure to collect HRQoL data in Polish patients with spinal stenosis. [b]materials and methods[/b]. Patients were eligible if they were above 18 years of age and had been qualified for spine surgery of the lumbar region due to either discopathy or non-traumatic spinal stenosis. All patients filled-in the Polish version of the SF-36 and a demographic questionnaire. Standard validity and reliability analyses were performed. [b]results.[/b] 192 patients (83 women – 43.2%) agreed to take part in the study (mean age: 57.5±11.4 years). In 47 patients (24.5%), using MRI, ossification of the ligamenta flava were found. Cronbach’s alpha coefficients showed positive internal consistency (0.70–0.92). Interclass correlations for the SF-36 ranged from 0.72 – 0.86 and proved appropriate test-retest reliability. Satisfactory convergent and discriminant validity in multi-trait scaling analyses was seen. [b]conclusions.[/b] The Polish version of the SF-36 is a reliable and valid tool for measuring HRQoL in patients with spinal stenosis. It can be recommended for use in clinical and epidemiological settings in the Polish population. However, caution is warranted when interpreting the results of the ‘role limitations due to physical health problems’ and the ‘role limitations due to emotional problems’ scales because of floor and ceiling effects

Variations and morphometric analysis of the proximal segment of the superior cerebellar artery

Introduction The superior cerebral artery is a clinically significant vessel, but little is known about its radiological anatomy. The aim of this study was to describe the anatomical variations of the proximal segment of the superior cerebellar artery using Computed Tomography Angiography. Materials and methods The study group consisted of 200 subjects (54.5% female, mean age±SD 56.2±17.2 years) that had undergone head Computed Tomography Angiography. Subjects with any intracranial pathologies were excluded. Images in Maximum Intensity Projections were used to study the anatomical anomalies of the superior cerebellar artery. Results In 200 subject 388 superior cerebellar arteries were found. Twelve (3.09%) SCAs were duplicated in 11 patients and all originated from the basilar artery. In 8 (4.00%) patients the superior cerebellar artery was absent. The origin of the SCA was most often bilateral, mainly from the basilar artery (76.29%). The superior cerebellar artery diameter, measured at the site of the origin, was statistically significantly different depending on the place of the origin: wider when originating from the basilar artery as a single vessel (1.48±0.42mm vs. 1.34±0.52mm; p=0.03) and narrower when originating as duplicated one (1.38±0.48mm vs. 1.46±0.44mm; p=0.55). Conclusion Superior cerebellar artery usually originates bilaterally from the basilar artery as a single trunk. Its diameter is significantly wider in that type in comparison to other anatomical variations

Use of complementary and alternative medicine among Polish cancer patients

Introduction. The aim of this prospective study was to estimate the perception and popularity of complementary and alternative medicine (CAM) subtypes and the reasons for usage among adult Polish cancer patients. Material and methods. The validated questionnaire was conducted among 310 patients. 24.1% of the patients used CAM during their oncological treatment. Risk factors for CAM usage were: female gender, university degree and radical treatment. The most common reasons for CAM usage were: boosting the immune system (46.1%), improving well-being/ counteracting the ill effects of cancer and its treatment (40.8%). The average level of satisfaction with CAM was high (≥3/5 on a Likert scale). Nearly half of the patients (46.6%) admitted not informing their doctors about their CAM usage. Conclusions. The growing popularity and heterogeneity of CAM methods make it an important issue for patient–doctor relations in Poland and other Central European countries. The results of this study indicate what topics should be covered while introducing patient education programs

Pharmacological characterization of nanoparticle-induced platelet microaggregation using quartz crystal microbalance with dissipation: comparison with light aggregometry

Background: Engineered nanoparticles (NPs) can induce platelet activation and aggregation, but the mechanisms underlying these interactions are not well understood. This could be due in part to use of devices that study platelet function under quasi-static conditions with low sensitivity to measure platelet microaggregation. Therefore, in this study we investigated the pharmacological pathways and regulators of NP-induced platelet microaggregation under flow conditions at nanoscale using quartz crystal microbalance with dissipation (QCM-D) and compared the data thus obtained with those generated by light aggregometry. Methods: Blood was collected from healthy volunteers, and platelet-rich plasma was obtained. Thrombin receptor-activating peptide, a potent stimulator of platelet function, and pharmacological inhibitors were used to modulate platelet microaggregation in the presence/absence of silica (10 nm and 50 nm) and polystyrene (23 nm) NPs. Light aggregometry was used to study platelet aggregation in macroscale. Optical, immunofluorescence, and scanning electron microscopy were also used to visualize platelet aggregates. Results: Platelet microaggregation was enhanced by thrombin receptor-activating peptide, whereas prostacyclin, nitric oxide donors, acetylsalicylic acid, and phenanthroline, but not adenosine diphosphate (ADP) blockers, were able to inhibit platelet microaggregation. NPs caused platelet microaggregation, an effect not detectable by light aggregometry. NP-induced microaggregation was attenuated by platelet inhibitors. Conclusion: NP-induced platelet microaggregation appears to involve classical proaggregatory pathways (thromboxane A2-mediated and matrix metalloproteinase-2-mediated) and can be regulated by endogenous (prostacyclin) and pharmacological (acetylsalicylic acid, phenanthroline, and nitric oxide donors) inhibitors of platelet function. Quartz crystal microbalance with dissipation, but not light aggregometry, is an appropriate method for studying NP-induced microaggregation