A comparison of simple single-item measures and the NCI Common Toxicity Criteria version 3.0 measure of peripheral neuropathy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1557-1557
Author(s):  
Suneetha Puttabasavaiah ◽  
Heshan Liu ◽  
Rui Qin ◽  
Lisa A. Kottschade ◽  
Debra L. Barton ◽  
...  

1557 Background: Peripheral neuropathy (PN), a common and intrusive side effect of chemotherapy in clinical trials, has been assessed via the clinician-rated common terminology criteria for adverse events (CTCAE) and/or patient-reported outcome (PRO) measures (Morton, ASCO, 2005). We assessed the relative sensitivity of CTCAE and PRO measures for evaluating interventions for preventing and ameliorating CIPN. Methods: Data from285 patients in two prevention trials (N05C3, N04C7) and 432 patients from three intervention trials (N00C3, N01C3, N06CA) were analyzed separately. CTCAE version 3.0 item for neuropathy was compared to 2 NCCTG numerical analogue CIPN items, 6 EORTC CIPN20 individual items, 2 McGill Pain Questionnaire items, and one Brief Pain Inventory item. The sample size provided over 80% power to detect a true Spearman rank correlation of 0.15 assessed the relationship between CTCAE and PRO measures. Results: Results from both the prevention and treatment trials were similar in terms of the relationship between the CTCAE and PRO measures. No correlation coefficients between the CTCAE and any of the PRO items at baseline were above 0.35, with the majority around 0.2. Higher scores for the numbness items were observed than for the CTCAE in 47% of the patients at baseline and 39% during treatment in the treatment trials. Many patients had severe numbness PRO scores but mild CTCAE scores (12%) at baseline and (8%) during treatment in the treatment trials. Results for the numbness and tingling PRO measures were redundant. The correlations of the CTCAE with pain were weak, all below 0.35 at baseline with differences as much as 29 points on average on a 0-100 transformed scale. Conclusions: The CTCAE and PRO measures of PN measure different constructs. The CTCAE includes both functional and ADL/motor aspects which may or may not be related to the singular constructs of pain, numbness, tingling, or adjectival characteristics of pain assessed by the PRO measures. The two measures cannot be used in place of each other.

2020 ◽  
pp. 104345422098025
Author(s):  
Ellen M. Lavoie Smith ◽  
Clare Kuisell ◽  
Grace Kanzawa-Lee ◽  
Celia M. Bridges ◽  
Youmin Cho ◽  
...  

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is commonly experienced by children receiving neurotoxic chemotherapy. No validated pediatric CIPN patient-reported outcome (PRO) measures exist. Purpose: To test sensitivity, internal consistency reliability, content and convergent validity, and feasibility of the Pediatric Chemotherapy-Induced Neuropathy (P-CIN), an electronic PRO measure for assessing CIPN in children who received neurotoxic chemotherapy. Method: Five experts evaluated content validity of the 14-item P-CIN. Children 5 to 17 years old with CIPN ( N = 79) completed the P-CIN via tablet computer; a subset ( n = 26) also underwent neurological examinations using the Pediatric–Modified Total Neuropathy Score. Following preliminary analyses, one item was deleted and three others modified. The revised P-CIN was retested with patients ( n = 6) who also completed the Bruininks–Oseretsky Test of Motor Proficiency motor function assessment. Means, item response ranges, standard deviations, content validity indexes, Cronbach’s alphas, and correlation coefficients were calculated. Results: Mean participant age was 11.25 ( SD = 4.0) years. Most had acute leukemia (62.5%) and received vincristine (98.7%). Content validity index coefficients ranged from .80 to 1.0 ( p = .05). For 9 of 14 items, responses ranged from 0 to 4 or 5; response ranges for toe numbness, pick up a coin, and three of four pain items were 0 to 3. After deleting one item, Cronbach’s alpha coefficient was .83. P-CIN scores were strongly associated with Pediatric-Modified Total Neuropathy Score ( r = .52, p < .01) and Bruininks–Oseretsky Test of Motor Proficiency ( r = −.83, p = .04) scores. Sixty-eight percent of children 6 to 17 years old completed P-CIN independently. Discussion: Preliminary evidence suggests that the 13-item P-CIN is internally consistent, is valid, and can be completed independently by children ≥ 6 years. However, we recommend additional testing.


Energies ◽  
2021 ◽  
Vol 14 (11) ◽  
pp. 3119
Author(s):  
Yinjiao Su ◽  
Xuan Liu ◽  
Yang Teng ◽  
Kai Zhang

Mercury (Hg) is a toxic trace element emitted from coal conversion and utilization. Samples with different coal ranks and gangue from Ningwu Coalfield are selected and investigated in this study. For understanding dependence of mercury distribution characteristics on coalification degree, Pearson regression analysis coupled with Spearman rank correlation is employed to explore the relationship between mercury and sulfur, mercury and ash in coal, and sequential chemical extraction method is adopted to recognize the Hg speciation in the samples of coal and gangue. The measured results show that Hg is positively related to total sulfur content in coal and the affinity of Hg to different sulfur forms varies with the coalification degree. Organic sulfur has the biggest impact on Hg in peat, which becomes weak with increasing the coalification degree from lignite to bituminous coal. Sulfate sulfur is only related to Hg in peat or lignite as little content in coal. However, the Pearson linear correlation coefficients of Hg and pyritic sulfur are relatively high with 0.479 for lignite, 0.709 for sub-bituminous coal and 0.887 for bituminous coal. Hg is also related to ash content in coal, whose Pearson linear correlation coefficients are 0.504, 0.774 and 0.827 respectively, in lignite, sub-bituminous coal and bituminous coal. Furthermore, Hg distribution is directly depended on own speciation in coal. The total proportion of F2 + F3 + F4 is increased from 41.5% in peat to 87.4% in bituminous coal, but the average proportion of F5 is decreased from 56.8% in peat to 12.4% in bituminous coal. The above findings imply that both Hg and sulfur enrich in coal largely due to the migration from organic state to inorganic state with the increase of coalification degree in Ningwu Coalfield.


BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034355 ◽  
Author(s):  
Myla D Goldman ◽  
Seulgi Min ◽  
Jennifer M Lobo ◽  
Min-Woong Sohn

ObjectiveTo examine the relationship between visit-to-visit systolic blood pressure (SBP) variability and patient-reported outcome measure of disability in multiple sclerosis (MS) patients.DesignA retrospective cohort study of individuals with MS who completed a patient-determined disease steps (PDDS) scale between 2011 and 2015 at an MS specialty clinic.ParticipantsIndividuals with MS for whom both a completed PDDS scale and ≥3 SBP measures within the prior 12 months of the survey were available.Main outcome measureParticipants were grouped into three classes of disability (no or mild (PDDS 0–1), moderate (2–3), severe (4–7)). SBP variability was calculated as within-subject SD using all SBP measures taken during the past 12 months. SBP variability was analysed by Tertile groups.ResultsNinety-two subjects were included in this analysis. Mean PDDS score was 2.22±1.89. Compared with subjects in Tertile 1 (lowest variability), the odds of being in a higher disability group was 3.5 times higher (OR=3.48; 95% CI: 1.08 to 11.25; p=0.037) in Tertile 2 and 5.2 times higher (OR=5.19; 95% CI: 1.53 to 17.61; p=0.008) in Tertile 3 (highest variability), independent of mean SBP, age, sex, race/ethnicity, body mass index and comorbidities (p for trend=0.008). Mean PDDS scores were 1.52±1.18 in Tertile 1, 2.73±1.02 in Tertile 2 and 2.42±0.89 in Tertile 3 after adjusting for the same covariates.ConclusionsOur results show a significant gradient relationship between SBP variability and MS-related disability. More research is needed to determine the underlying pathophysiological relationship between SBP variability and MS disability progression.


2016 ◽  
Vol 98-B (9) ◽  
pp. 1234-1239 ◽  
Author(s):  
H. M. Yu ◽  
K. Malhotra ◽  
J. S. Butler ◽  
A. Patel ◽  
M. D. Sewell ◽  
...  

2020 ◽  
Author(s):  
Hiroto Taniguchi ◽  
Masafumi Itoh ◽  
Nobuyuki Yoshimoto ◽  
Junya Itou ◽  
Umito Kuwashima ◽  
...  

Abstract Background: Some patients complain of noise after total knee arthroplasty (TKA). Controversy still exists how the noise affect the clinical outcomes including joint awareness after TKA. Forgotten Joint Score-12 (FJS-12) measures the clinical outcomes focusing on joint awareness after surgery. The Knee Society Scoring System-2011 (KSS-2011) includes questionnaires for satisfaction, expectation, and functional activities. The aim of this study is to clarify the relationship among FJS-12, KSS-2011 and the noise. Furthermore, the relationship between FJS-12 and KSS-2011 was validated. Methods: Using the FJS-12 and KSS-2011, 295 knees from 225 patients who underwent TKA was retrospectively evaluated. Noise perception was evaluated by a questionnaire with five grades which is a method that follows the questionnaire form of FJS-12 [“Are you aware of the noise of your artificial joint?” ; never, almost never, seldom, sometimes, mostly]. The correlations among FJS-12, KSS-2011, and noise were analyzed. In addition, patients were divided into four groups based on the mechanism of their implant [cruciate retaining, posterior stabilized, cruciate sacrificed, and bicruciate stabilized (BCS)]. FJS-12, KSS-2011, and noise were compared among the groups. Results: A strong correlation was observed between FJS-12 and the total score of KSS-2011 (0.70; P < 0.001). FJS-12 also was correlated with KSS-2011 subcategories for “symptoms,” “satisfaction,” and “standard activities” that these correlation coefficients were approximately 0.60. Noise was limited to have weak correlations with FJS-12 (0.28; P < 0.001) and KSS-2011 (0.20 P < 0.001). With comparison among the TKA mechanisms, BCS showed significantly better KSS-2011 and greater range of movement but worse noise scores. Conclusions: Noise perception after TKA had limited effect on joint awareness and clinical outcomes. FJS-12 was correlated strongly with KSS-2011 and associated with satisfaction, residual symptoms, and daily activities as assessed by KSS-2011 subscores.


Author(s):  
Alena Klapalová

The purpose of this paper is to presents results from two empirical surveys concerning selected factors which can be connected to customer orientation, performance and competitiveness of firms. The purpose of the surveys was also to reveal potential differences between sectors arising from not only the different influences of internal but as well as external environment. A survey instrument was developed to analyse the relationship between several variables measuring customer orientation of surveyed firms and between these factors and level of financial performance. Several statistical methods were applied to analyse the data, specifically descriptive statistics (means and standard deviations), one-way analysis of variance (ANOVA) with Bonferroni post-hoc test using financial performance for clustering firms and for assessment of potential differences of customer orientation criteria evaluation and Spearman rank correlation coefficients to assess the linear bivariate relationship between customer orientation variables. The results of ANOVA show that only the innovativeness is distinctive distinguishing criteria in conformity with the indicators of financial prosperity and that there are some differences between companies from two groups of sectors within the managers’ perception of customer orientation criteria performance.


2020 ◽  
Vol 28 (2) ◽  
pp. 230949902091510
Author(s):  
Takao Kaneko ◽  
Norihiko Kono ◽  
Yuta Mochizuki ◽  
Masaru Hada ◽  
Shinya Toyoda ◽  
...  

Objective: Insall advocated that a successful clinical outcome of total knee arthroplasty (TKA) depends on soft tissue balance procedure. Spacer blocks, balancer, and instrumented tibial sensor (VERESENSE, OrthoSensor, Dania, Florida, USA) are the current methods of soft tissue balancing during TKA. The purpose of the study is to assess intraoperative medial and lateral tibiofemoral compressive force (TFCF) using novel insert sensor and investigate the relationship between TFCF and patient-reported outcome measurements (PROMs). Methods: Twenty-five patients who underwent bicruciate stabilized (BCS) TKA were evaluated retrospectively. We measured intraoperative medial and lateral TFCF in neutral position as well as the force ratio (FR %:medial TFCF/medial + lateral TFCF) in varus and valgus position using the novel insert sensor throughout the range of motion (ROM) and assessed the relationship between intraoperative medial and lateral TFCF and PROM at 6 months after TKA. Results: Medial TFCF increased and lateral TFCF decreased throughout ROM. The mean FR was 0.44% ± 0.22 throughout ROM. Medial and lateral TFCF differences at 60° of ROM in neutral position showed a positive correlation with physical function in Western Ontario and McMaster Universities scores ( r = 0.60, p < 0.05). Medial and lateral TFCF differences at 30° and 140° of ROM in valgus stress test showed a positive correlation with symptoms in 2011 Knee Society Scores ( r = 0.49, p < 0.05; r = 0.51, p < 0.05). Conclusion: The present study revealed that BCS TKA reproduces the coronal laxity, which is similar to healthy knee. These results suggest that intraoperative medial stability is important for function and symptoms, therefore, surgeons should not release medial soft tissue for achieving better clinical outcomes after BCS TKA. Level of Evidence: II


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