Total Score Of Patients Research Articles

G8 screening and health-care use in patients with cancer

G8 screening and health-care use in patients with cancer

The efficacy and safety of lurasidone in bipolar I depression with and without rapid cycling: A pooled post-hoc analysis of two randomized, placebo-controlled trials

BackgroundThe efficacy and safety of lurasidone monotherapy in patients with bipolar I depression with or without rapid cycling has not been previously investigated. MethodsWe performed subgroup analysis (rapid cycling/non-rapid cycling) of pooled data from two 6-week, randomized, double-blind, placebo-controlled trials of lurasidone monotherapy (20–60 mg/day or 80–120 mg/day). Analyses included mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Safety assessments included the number of treatment-emergent adverse events (TEAEs) and laboratory assessments. ResultsOf 1024 patients randomized, 85 were rapid cycling. Mean change in MADRS total score in patients with non-rapid cycling and rapid cycling, respectively, was −14.8 (effect size = 0.47) and − 12.8 (effect size = 0.04) in the lurasidone 20–60 mg/day group, −14.3 (effect size = 0.41) and − 13.0 (effect size = 0.02) in the lurasidone 80–120 mg/day group and −10.6 and −13.3 in the placebo group. The most common TEAE in each subgroup was akathisia in both lurasidone groups. Treatment-emergent mania was reported only in a small number of rapid cycling and non-rapid cycling patients. LimitationsThis was a post-hoc analysis of a short-term study that excluded patients with ≥8 cycles in the past year. ConclusionsIn patients with non-rapid cycling bipolar depression, lurasidone monotherapy significantly improved depressive symptoms relative to placebo at both the 20–60 mg/day and 80–120 mg/day doses. In patients with rapid cycling, both doses of lurasidone displayed depressive symptom score reduction from baseline, but significant improvement was not observed likely due to high levels of improvement on placebo and small sample size.

A cross-sectional survey and analysis of the pain status and its influencing factors in diabetic foot ulcer patients

Objective: To investigate the pain status in diabetic foot ulcer (DFU) patients and analyze its influencing factors. Methods: A single-center cross-sectional survey research method was used. From May 2021 to February 2022, DFU patients who were admitted to the Fourth Medical Center of PLA General Hospital and met the inclusion criteria were selected and investigated. The scores of the heaviest pain, the least pain, the average pain, and the current pain in pain degree and the total score and the scores of influence on patients' daily life, mood, walking ability, daily work, relationship with others, sleep, and life interest in pain-related effects and the total score of patients were evaluated by the brief pain inventory. A self-designed general data questionnaire was used to collect the data including patients' gender, age, education level, body mass index, self-care ability, diabetes course, wound Wagner grade, bacterial culture result of wound specimen, and the levels of glycated hemoglobin, albumin, prealbumin, hemoglobin, and leukocyte count. Patients were classified according to general data, and the total scores of pain degree and pain-related effects were counted. Data were statistically analyzed with Kruskal-Wallis test and Mann-Whitney U test. The indicators with statistically significant differences in univariate analysis were selected for generalized linear model analysis to screen the independent risk factors of pain severity and pain-related effects in DFU patients. Results: A total of 44 questionnaires were sent out, and 42 valid questionnaires were collected, with effective recovery of 95.45%. The scores of the heaviest pain, the least pain, the average pain, and the current pain in DFU patients were 5 (0, 10), 2 (0, 6), 3 (0, 8), and 2 (0, 8), respectively, and the total score of the pain severity was 11 (0, 24); the scores of pain-related effects on patients' daily life, mood, walking ability, daily work, relationship with others, sleep, and life interest were 4 (0, 10), 4 (0, 10), 5 (0, 10), 5 (0, 10), 3 (0, 10), 4 (0, 10), and 4 (0, 10), respectively, and the total score of pain-related effects was 30 (0, 63). In 42 DFU patients, most patients were male, aged 39-87 (67±10) years, most patients had education level of junior high school, most patients had diabetes for more than 20 years, half of patients' wounds were Wagner grade 4, most patients had body mass index and leukocyte count within normal limits, most patients had partial dependence on self-care ability, the bacterial culture results of wound specimen in the vast majority of patients were positive, about half of the patients had abnormal level of albumin, and most patients had abnormal levels of glycosylated hemoglobin, prealbumin, and hemoglobin. Univariate analysis of the above general data showed that total scores of pain severity among patients with different hemoglobin levels and leukocyte counts were statistically significant different (with Z values of -2.05 and -2.55, respectively, P<0.05), and the total scores of pain-related effects on patients with different hemoglobin levels, leukocyte counts, and bacterial culture results of wound specimen were statistically significant different (with Z values of -2.66, -2.02, and -2.12, respectively, P<0.05). Generalized linear model analysis showed that leukocyte count was an independent risk factor for pain severity and pain-related effects in 42 DFU patients (with 95% confidence intervals of 0.28-11.87 and 5.67-36.99, respectively, standardized regression coefficient values of 6.17 and 21.33, respectively, both P values <0.05). The bacterial culture result of wound specimen was an independent risk factor for pain-related effects in 42 DFU patients (with 95% confidence interval of 2.92-39.09, standardized regression coefficient value of 21.00, P<0.05). Conclusions: DFU patients often suffer pain, and the bacterial culture results of wound specimen and leukocyte count are the main factors affecting the pain of DFU patients.

Outcomes and Patient Experience in Individuals With Longstanding Dizziness.

This study aimed to describe the relationship between changes in pre and post self-perceived dizziness handicap, scores on the patient health questionnaire, and perceptions of patient's value of being evaluated and managed by a multidisciplinary team. Seventy-eight patients completed the Dizziness Handicap Inventory (DHI) and Patient Health Questionnaire-Fourth Edition (PHQ-4) questionnaires post multidisciplinary clinical consultations and testing for the chief complaints of dizziness, unsteadiness, vertigo, or balance problems. The diagnoses of each patient were recorded from the clinical reports of each specialty consultation and were classified as structural, functional, or psychiatric. They were contacted by phone at least 6 months after their visit to obtain feedback regarding their symptoms and overall patient experience. The change in DHI total score did not differ significantly by diagnosis (p = .56), indicating that patients experienced an improvement in DHI total score regardless of diagnosis. PHQ-4 anxiety scores worsened by a mean of 0.7 points for those with structural diagnoses (p = .04), improved by a mean of 0.7 points for psychiatric diagnoses (p = .16), and improved by a mean of 0.3 points for functional diagnoses (p = .39). Only seven patients would not recommend the team to a family or friend; these patients tended to report worsening DHI total scores (p = .27) compared to the significant improvement in DHI total scores for patients who would make such a recommendation (p < .001). Similarly, only 13 patients did not feel the information they received had a positive impact; these patients tended to report worsening DHI total scores (p = .18) compared to the significant improvement in DHI total scores for patients who did feel the information had a positive impact (p < .001). The assessment and management of patients with chronic dizziness is challenging due to symptoms arising from multiple etiologies. Our finding of a vast difference between high satisfaction and relatively unchanged dizziness handicap suggests that there is value in seeing a multidisciplinary team where consultations are unhurried, care is coordinated, and expectations regarding treatment can be managed.

Nutritional Status in Patients Undergoing Phase II Cardiac Rehabilitation by Mini Nutritional Assessment

Malnutrition impairs quality of life and prognosis of patients with cardiovascular disease. The Mini Nutritional Assessment (MNA) is a screening tool developed for the nutritional assessment of older adults. However, usefulness of MNA for patients undergoing cardiac rehabilitation (CR) has not been fully investigated. From March 2017 to September 2019, the MNA-short form (MNA-SF) and the MNA total score in patients undergoing phase II CR at the Juntendo University Hospital were evaluated. A total of 336 patients (mean age 70.1 ± 11.4 years; males: 209) were analyzed. In the MNA-SF, 157 patients (47%) were found to be malnourished or at risk of malnutrition. In MNA total score, 168 patients (50%) were found to be malnourished or at risk of malnutrition. The MNA-SF < 12 group had significantly lower body mass index (BMI), hemoglobin level, low MNA scores for protein/water intake, self-evaluation of nutrition and health, and upper arm and calf circumferences compared to the MNA-SF ≥ 12 group. Assuming BMI < 18.5 as malnutrition, the sensitivity and specificity for malnutrition were 100% and 58.9% for MNA-SF, and 96.9% and 54.9% for MNA total score, respectively. MNA is useful in screening for malnutrition in patients undergoing CR. Approximately 50% of them were determined to be malnourished or at risk of malnutrition, suggesting the need for detailed evaluation regarding their food intake and dietary intervention.

Persian Version of the Hyperacusis Questionnaire: The Translation Process, Psychometric Properties, and Diagnostic Criteria in Normal Hearing People

Objectives: The current study was performed to determine the validity and reliability of the Persian version of the Khalfa Hyperacusis questionnaire (HQ) and its differential validity between normal people and patients with hyperacusis or tinnitus. Methods: The international quality of life assessment (IQoLA) method was considered for the translation process. After determining face and content validities of the Persian version, 81 patients with hyperacusis and or tinnitus (22 participants with hyperacusis, 18 with hyperacusis and tinnitus and 41 with tinnitus) with a mean age of 40±2.9 years and 80 normal people with a mean age of 36.9±1.31 years were tested for reliability and differential validity for clinical use. The reliability of this questionnaire was tested through the test-retest method in all participants of both groups with an interval of two weeks. Results: The content validity ratio and content validity index approved the face validity of the Persian version of the HQ. The average total score for patients in group 1 was 21.3, significantly higher than 3.75 for the normal group. A high total score Cronbach coefficient was found to be 0.90, which approved the internal consistency of the HQ. The cut-off point of the questionnaire was estimated to be 17.5 for the total HQ score in the Persian version. The Persian version of the HQ shows high reliability with an intraclass correlation coefficient of 0.97. Discussion: The Persian version of the HQ showed high validity and reliability, which suggests its usefulness in hyperacusis clinics. A total HQ score of 17.5 or more is indicated as a cut-off point for classifying hyperacusis patients. Further studies on other populations are suggested for generalizing the results.

Structural and functional deficits and couplings in severe and moderate OCD

Changes in gray matter volume and functional connections have been frequently observed in patients with obsessive compulsive disorder. However, different grouping may cause diverse volume alterations and could draw more adverse conclusions about the pathophysiology of obsessive compulsive disorder(OCD). Most of them preferred to divide subjects into patients and healthy controls, rather than a detailed subgroup. Moreover, multimodal neuroimaging studies about structural-functional defects and couplings are rather rare. Our aim was to explore gray matter volume(GMV) and functional networks abnormalities induced by structural deficits based on severity of Yale-Brown Obsessive Compulsive Scale(Y-BOCS) symptom including OCD patients with severe(S-OCD, n = 31) and moderate symptoms(M-OCD, n = 42) and healthy controls (HCs, n = 54); Voxel-based morphometry(VBM) method was used to detect GMV differences among three groups, then used as masks according to one-way analysis of variance(ANOVA) results for the subsequent resting-state functional connectivity(rs-FC) analysis. Besides, correlation and subgroup analysis were performed to detect the potential roles of structural deficits between every two groups. ANOVA analysis showed that both S-OCD and M-OCD had increased volume in anterior cingulate cortex(ACC), left precuneus(L-Pre) and paracentral lobule(PCL), postcentral gyrus, left inferior occipital gyrus(L-IOG) and right superior occipital gyrus(R-SOG) and bilateral cuneus, middle occipital gyrus(MOG), and calcarine. Additionally, increased connections between Pre and angular gyrus(AG) and inferior parietal lobule(IPL) have been found. Moreover, connections between the left cuneus and lingual gyrus, between IOG and left lingual gyrus, fusiform and between L-MOG and cerebellum were also included. Subgroup analysis showed that decreased GMV in left caudate was negatively correlated with compulsion and total score in patients with moderate symptom compared to HCs. Our findings indicated that altered GMV in occipital-related regions, Pre, ACC and PCL and the disrupted FC networks including MOG-cerebellum and Pre-AG and IPL. Moreover, subgroup GMV analysis furtherly revealed negative associations between GMV changes and Y-BOCS symptom, offering preparatory proof for the involvement of structural and functional deficits in cortical-subcortical circuitry. Thus, they could provide insights into the neurobiological basis.

Internet-based basic body awareness therapy in fibromyalgia syndrome: A report of three cases.

Previous literature has shown that basic body awareness therapy (BBAT) may be an effective treatment for fibromyalgia syndrome (FMS). This study constitutes the first case study evaluating internet-based BBAT for FMS. The purpose of this case study was to describe the feasibility and preliminary outcomes of an internet-based BBAT training for a total of 8 weeks in three patients with FMS. The patients underwent a synchronous individual internet-based BBAT training. Outcomes were assessed using Fibromyalgia Impact Questionnaire Revised, Awareness-Body-Chart, Short-Form McGill Pain Questionnaire (SF-MPQ), and plasma fibrinogen level. These measures were administered at baseline and after the treatment. Patient satisfaction with the treatment was evaluated using a structured questionnaire. At the post-treatment evaluation, each patient showed improvements in all outcome measures. All patients had clinically significant changes in Fibromyalgia Impact Questionnaire Revised. The SF-MPQ total score in Patients 1 and 3 exceeded the minimal clinically important difference. All patients' pain severity exceeded the minimal clinically important difference for Visual Analogue Scale (SF-MPQ). Besides, we found some benefits in body awareness and the level of dysautonomia. At the end of the treatment, patient satisfaction with the programme was very high. Based on this case study, the application of internet-based BBAT seems feasible and promising for clinical benefits.

Cerebellar repetitive transcranial magnetic stimulation versus propranolol for essential tremor.

Propranolol, a nonselective beta-adrenergic blocker, has long been used as one of the standard treatments for essential tremor (ET). Repetitive transcranial magnetic stimulation (rTMS) has also been used for a long time as a substitution therapy for ET patients. The main aim of this study was to evaluate the antitremor effect of 1-Hz (low-frequency) cerebellar rTMS and compare it to the use of propranolol in ET patients. In this single-blinded, randomized, controlled pilot study, a total of 38 patients with ET were randomized into two groups. One group (n=20) received 1200 pulses of 1-Hz rTMS at an intensity of 90% of the resting motor threshold to the bilateral cerebellar region for 10days. Another group (n=18) received oral propranolol for 30 days. The initial dose was 30mg/day, which was increased to 60mg/day after 5days, then to 90mg/day on the 11th day, and continued thereafter for 20days. The Fahn-Tolosa-Marin (FTM) clinical scale was assessed at baseline and at days 5, 10, and 30 to evaluate tremor severity, specific motor tasks, and functional disability. Low-frequency rTMS of the cerebellum significantly improved tremor severity, specific motor tasks (writing, spiral drawing, and pouring), and FTM total scores on days 10 and 30. Nevertheless, we found no significant difference in functional disability at any point in time (p>.05). There were no statistically significant differences in FTM Part A, Part B, Part C scores and total scores of patients in propranolol group on days 5 and 10 compared with before treatment (p>.05). However, FTM total scores and FTM Part A, Part B, and Part C scores were significantly improved for patients when the dose of propranolol was 90mg/day on day 30. Our study showed that there was no statistically significant difference in the total FTM scores and FTM Part A, Part B, and Part C scores between rTMS and propranolol on days 5, 10, and 30 (p>.05). We conclude that both cerebellar low-frequency rTMS and propranolol could be effective treatment options for patients with ET, but it is not clear which method is more effective.

Comparing the Performance of Emergency Department Personnel and Patients' Preferences in Breaking Bad News.

Breaking bad news (BBN) is a critical aspect of healthcare delivery that can have significant implications for patients' outcomes. Inadequate and inappropriate delivery of bad news can result in detrimental psychological and emotional effects. This study aimed to compare the performance of emergency department (ED) personnel and patients' preferences in BBN. This descriptive-analytical study was conducted in 2022, and 135 patients who were admitted to the ED were included using quota sampling. Data were collected using a demographic questionnaire, a researcher-made questionnaire, and a standard questionnaire on attitudes toward the methods of BBN in the ED. The data were analyzed using SPSS software (version 16), and a p-value<0.05 was considered statistically significant. The results showed that the majority of patients (69.6%) received bad news from nurses. Based on the conditions mentioned in the standard questionnaire, the overall performance of personnel was 6.08±4.22 out of 19, while the overall attitude score (59.66±7.66 out of 76) revealed patients' high tendency to receive bad news. There was a statistically significant difference between the total score of personnel performances and the total score of patients' attitudes (p=0.001). The performance of ED personnel concerning patients' attitudes toward the method of BBN in the emergency department was not optimal. Therefore, it is recommended to implement appropriate training programs for medical professionals, especially physicians, and nurses, to enhance their communication skills and reduce the detrimental effects of inappropriate delivery of bad news in medical settings.

Application of health education based on the integrated theory of health behavior change in the pelvic floor rehabilitation of patients with cervical cancer after radical surgery

To analyze the effect of applying health education based on the integrated theory of health behavior change in the pelvic floor rehabilitation of patients with cervical cancer after radical surgery. We recruited 130 patients with cervical cancer who underwent gynecological surgery in our hospital between the 01 February 2021 and the 01 March 2022. According to the random number table method, the patients were divided into a control group and an observation group (65 cases per group). The control group received routine health education, while the observation group received health education based on the integrated theory of health behavior change. We compared the two groups with regards to pelvic floor function, quality-of-life, and psychological status before and after intervention by analyzing PFDI-20 (Pelvic Floor Distress Inventory Questionnaire-20), PFIQ-7 (Pelvic Floor Impact Questionnaire-7), HAMA (Hamilton Anxiety Scale) and HAMD (Hamilton Depression Scale) questionnaires, treatment compliance and nursing satisfaction. After intervention, the PFDI-20 scores and total scores of patients in the observation group were lower than those in the control group (p &lt; 0.05). The PFIQ-7 scores and total scores of patients in the observation group were lower than those in the control group (p &lt; 0.05). The HAMA and HAMD scores in the observation group were significantly lower than those in the control group (p &lt; 0.05). The treatment compliance and nursing satisfaction rate of patients in the observation group were higher than those in the control group (p &lt; 0.05). Health education based on the integrated theory of health behavior change can improve pelvic floor muscle strength, the quality-of-life, and the treatment compliance of patients after radical surgery for cervical cancer. In addition, this strategy can alleviate anxiety and depression, and improve nursing satisfaction and is worthy of wider clinical application.

Associations between paraclinical parameters, symptoms and quality of life in patients with acromegaly: a cross sectional study

IntroductionAcromegaly is a rare chronic endocrine disorder that can lead to significant quality of life (QoL) impairment and persistent symptomatology in both biochemically uncontrolled as well as in cured or controlled patients. We aimed to conduct an observational cross-sectional study investigating the associations between biochemical disease control, associated comorbidities, and symptoms severity on QoL in a cohort of acromegalic patients.MethodsThirty-one patients with acromegaly were enrolled in our study. AcroQoL and PASQ (Pain assessed acromegaly symptoms questionnaire) questionnaires were applied to all patients. Information about disease status, associated comorbidities, and other relevant clinical and paraclinical data were gathered.ResultsPatients with uncontrolled acromegaly presented worse QoL and symptoms scores than controlled patients, but the difference was not statistically significant (AcroQoL 57.22 vs 64.04, p > 0.05; PASQ 12 vs 16.47, p > 0.05). Worse symptoms were significantly associated with impaired QoL (overall symptoms score on PASQ was negatively correlated with AcroQoL total score, r = − 0.61, p < 0.05). Cardiovascular complications were associated with lower QoL scores, but not with worse symptoms (AcroQoL total score in patients with- versus patients without cardiovascular complications: 54.89 vs 70.14, p < 0.05).ConclusionsAchieving biochemical control of acromegaly might not be enough to reverse the QoL impairment and improve symptomatology in acromegalic patients. While symptoms severity and the presence of cardiovascular complications seem to play an important role in reducing patients QoL, the roles of disease control, diabetes, and pituitary insufficiency are less clear.

Evaluation of symptom control and functional quality of life in Turkish patients with cancer during chemotherapy.

This study was designed to evaluate the severity of symptoms, functional quality of life, and related factors experienced by Turkish cancer patients receiving chemotherapy. The study was carried out with 430 patients at a medical oncology clinic. The data were collected using a personal and disease-related characteristics questionnaire, the Edmonton Symptom Assessment Scale (ESAS) and the Functional Life Scale-Cancer (FLIC). The three symptoms experienced most by patients were nausea (91.2%), depression (89.1%), and anxiety (87.7%). The mean FLIC total score of patients with cancer was 86.26±23.15. Age, ECOG performance score, pain, nausea, depression, and a decreased sense of well-being independently affected the FLIC score (p<0.05). There was a negative correlation between ESAS and FLIC scores (p<0.05). Nausea and psychological symptoms are common in Turkish patients with cancer. The more severe the symptoms, the worse the functional quality of life. Age, ECOG performance score, pain, nausea, depression, and decreased sense of well-being affect Turkish cancer patients' functional quality of life. We conclude that healthcare professionals should evaluate symptoms experienced by their patients and plan appropriate nursing interventions to address the symptoms experienced by Turkish patients with cancer.

Assessment of the functional status of patients with rheumatoid arthritis as a result of the physical therapy programme

Annotation. A differentiated strategy for the rehabilitation treatment of patients with rheumatoid arthritis is the development and implementation of a comprehensive therapeutic programme that includes the use of non-drug measures in addition to conservative therapy. The purpose of the paper is to evaluate the functional status of patients with rheumatoid arthritis as a result of the proposed physical therapy programme. Materials and methods. A total of 188 patients with rheumatoid arthritis were examined, with an average age of 44.9±7.6 years. All patients were randomly assigned to the control (n=92) and intervention (n=96) groups. Patients in the control group underwent rehabilitation in accordance with the recommendations of the regulatory document of the Ministry of Health of Ukraine. The physical therapy programme for patients of the main group is developed in accordance with the domains of the ICF, taking into account the factors that affect the level of functional impairment, health status and quality of life. The effectiveness of the proposed physical therapy programme on the functional status of patients with rheumatoid arthritis was assessed by the results of the Stanford Health Assessment Questionnaire. Results. At the beginning of the study, the total score for patients in the control group was 6.3±0.7 points and for the intervention group - 6.5±9.5 points. The greatest difficulties arose in getting dressed, including tying laces and fastening buttons, opening and closing a tap, bringing a full cup to the mouth, bending over and picking up an object from the floor. After 3 months, significantly better changes occurred in patients of the main group compared to the control group. So, in the patients of the main group, the total score decreased to 3.9±11.1 points, in the control group this score was worse and amounted to 4.7±2.3 points. After the treatment and physical therapy in 6 months, the functional status of patients in both groups improved, but the total score in the main group was significantly better and closer to normal (1.8±12.2 points) than in patients in the control group (2.9±4.1 points). Significantly better results of functional status indicators in patients of the main group indicate the effectiveness of the proposed physical therapy programme. Conclusion. Increased motor activity in the joints, muscle strength in the affected upper extremities as a result of the proposed physical therapy programme contributed to the improvement of daily activities and functional status of patients in the main group, as evidenced by the results of the Stanford Health Interview. Thus, significantly better changes occurred in the patients of the main group compared to the control group, where conventional rehabilitation treatment was performed.

SUSTAINED IMPROVEMENT IN HEALTH-RELATED QUALITY OF LIFE WITH CONTINUED LANADELUMAB TREATMENT IN HEREDITARY ANGIOEDEMA

<h3>Introduction</h3> Lanadelumab is approved for the prevention of hereditary angioedema attacks. Reduced attack rate is associated with improved health-related quality of life (HRQoL). HRQoL was assessed in patients who completed the HELP Study (NCT02586805) and rolled into the HELP OLE Study (NCT02741596) using the Angioedema Quality of Life Questionnaire (AE-QoL). <h3>Methods</h3> Rollover patients completed 26 weeks' treatment in HELP, where they received placebo or lanadelumab (150mg every 4 weeks [Q4W], 300mg Q4W, or 300mg every 2 weeks [Q2W]), then continued into HELP OLE with lanadelumab 300mg Q2W for ≤33 months. A decrease in AE-QoL total score of ≥6 was considered clinical meaningful improvement. <h3>Results</h3> From the baseline of HELP to the end of study (EOS) visit in HELP OLE, rollovers (n=98) had a mean(SD) change in AE-QoL total score of -25.1(19.8). The reduction of total score in rollovers (n=97) during HELP OLE was -10.2(17.9). Among patients who received lanadelumab 300mg Q2W in HELP (n=24), total scores for patients with baseline attack rates of 1–<2 (n=7), 2–<3 (n=5), and ≥3 (n=12) attacks/month were reduced from 23.1(27.3), 15.3(9.5), and 24.4(22.0), respectively, at HELP OLE baseline, to 10.3(8.9) 18.0(12.9), and 20.4(20.6), respectively, at EOS. For rollovers treated with placebo in HELP (n=33), total scores for patients with baseline attack rates of 1–<2 (n=10), 2–<3 (n=7), and ≥3 (n=16) attacks/month were reduced from 37.8(20.0), 36.3(14.2), and 43.2(23.4), respectively, at HELP OLE baseline, to 17.5(15.3), 8.6(8.4), and 27.4(24.6), respectively, at EOS. <h3>Conclusion</h3> These data demonstrate sustained clinically meaningful improvement in HRQoL with continued lanadelumab treatment.

Importance of TAK-1 levels in patients with non-small cell lung carcinoma.

In this study, we aimed to investigate the relationship between survival, tumor dimension, grade and stage in respect to transforming growth factor-β-activating kinase (TAK-1) extensity, severity and total score in patients undergoing resection for Stage 1B-2B non-small cell lung cancer. Between January 2000 and December 2014, a total of 70 patients (64 males, 6 females; mean age: 63.4+9.6 years; range, 32 to 78 years) who underwent surgery with resectable non-small cell lung cancer in Stage 1-2b were included. The patients were divided into two groups as Group 1 (n=35) consisting of patients with squamous cell carcinoma and Group 2 (n=35) consisting of patients with adenocarcinoma. The control group consisted of 20 patients (Group 3) who underwent surgery due to non-cancer causes. The relationship between TAK-1 staining (extensity, severity, total scores) and grade, survival time, T factor, N factor, and chemotherapy administration was examined. Pathology specimens of the patients were evaluated for the degree of staining with TAK-1 primary antibody. There was a strong correlation between the tumor grade and TAK-1 primary antibody staining level, independently from histopathological type. A significant correlation was found between dimension, stage, and TAK-1 staining in patients with squamous cell carcinoma. No statistically significant difference was found in the other factors, except for grade factor, in patients with adenocarcinoma. The current study provides precious information about the effects of TAK-1, in clinicopathological behavior and survival of malignant cells, particularly in common histopathological types of lung cancer. We believe that our data can be useful, particularly in evaluating the response to targeted therapies and the prognosis of the disease.

Clinically important change on the Unified Dyskinesia Rating Scale among patients with Parkinson's disease experiencing dyskinesia.

The Unified Dyskinesia Rating Scale (UDysRS) evaluates dyskinesia in patients with Parkinson's disease (PD). A minimal clinically important change (MCIC)-the smallest change in a treatment outcome that a patient considers important-remains undefined for the UDysRS. To utilize pivotal amantadine delayed-release/extended-release (DR/ER) trial data to derive MCICs for the UDysRS total score in patients with PD experiencing dyskinesia. Pivotal trials included PD patients with ≥1 h daily ON time with troublesome dyskinesia and baseline scores ≥2 on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, item 4.2. Patients randomized to amantadine DR/ER or placebo completed two consecutive 24-h diaries before each clinic visit and were evaluated during ON time with dyskinesia using the UDysRS, MDS-UPDRS, and Clinician Global Impression of Change (CGI-C). The UDysRS changes from baseline to week 12 were anchored to corresponding changes in MDS-UPDRS item 4.2 scores. A minimal clinically important improvement in the CGI-C and diary-reported ON time with troublesome dyskinesia (≥0.5 h) were supportive anchors. Receiver operating characteristic curves determined the UDysRS change values optimizing sensitivity and specificity to at least minimal improvement on each anchor. The analyses included 196 patients. Week 12 UDysRS total score reduction of ≥8 points corresponded to at least minimal MDS-UPDRS item 4.2 improvement. UDysRS reduction of ≥9 points corresponded to decreased ON time with troublesome dyskinesia of ≥0.5 h per patient diaries, and UDysRS reduction of ≥10 points corresponded to at least minimal improvement on the CGI-C. Anchored to the MDS-UPDRS Part IV, item 4.2, an 8-point reduction in the UDysRS total score can be considered an MCIC for PD patients with dyskinesia.

Autoantibodies may predict the neurological severity of patients with Wilson disease

Abstract Background Wilson's disease (WD) is a rare, autosomal disorder of copper metabolism, in which antibodies mediate and modulate the clinical manifestation of the CNS disease. The aim of this study was to investigate the presence and impact of autoantibodies in the clinical course of WD. Method Study involved 88 WD diagnosed and already treated patients with 7-years follow-up. Indirect immunofluorescence assays and Western Blot analysis was used. Results Patients who presented neurological manifestations had significantly more frequently ANA, ANCA and ANNA presence than in healthy individuals (p=0.029, p=0.009, p=0.025, respectively). In patients treated with d-penicillamine positive ANA antibodies were observed more frequently (p=0.005), whereas in zinc sulphate treated patients PP, ANCA and ANNA were significantly more frequently positive (p=0.038, p=0.024, p=0.002, respectively). Within the group of patients who died, positive ANA antibodies were significantly more frequent in comparison to patients who survived (p=0.020). Patients presenting positive cANCA had significantly higher UWDRS II, III and total scores compared to patients without ANCA antibody (p=0.033, p=0.022, p=0.022, respectively). Conclusion Drug-induced ANCAs may have a predictive value, as it is positively correlated with UWDRS II, III and total score in patients with WD. Only patients with neurological manifestations had significantly higher ANA, ANCA and ANNA presence. Increased positivity of those antibodies may predict the neurological manifestation of the severe cases and may be helpful for the neurological assessment of WD. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Medical University of Warsaw

The Relationship of Death Anxiety With Quality of Life and Social Support in Hemodialysis Patients.

This study aimed to determine the relationship of death anxiety with quality of life and social support in hemodialysis patients. This cross-sectional research was conducted on 226 patients with chronic renal failure. The results indicated that the means and standard deviations of MSPSS, QoL, and death anxiety of patients were 57.4 ± 10.1, 28.8 ± 5.9, and 42.5 ± 4.1, respectively. A significant negative correlation was found between QoL scores and death anxiety in hemodialysis patients (p = 0.007, r = -0.179). However, there was no statistically significant relationship between MSPSS scores and patients' death anxiety. The total score of patients' death anxiety decreased with increasing the total QoL score (p < 0.001, b = -0.18). Different variables that can affect death anxiety and QoL should be identified in the patient examination process. Also, the health care system should consider necessary planning to increase the QoL and reduce death anxiety.

Development and validation of the Japanese version of the Hyperarousal Scale

BackgroundThe objectives of this study were to develop a Japanese version of the Hyperarousal Scale (HAS-J) and investigate its factor structure, reliability, and validity, as well as to calculate a cutoff score for the HAS-J and assess different levels of hyperarousal in insomnia patients and community dwellers.MethodsWe recruited 224 outpatients receiving insomnia treatment (56.3% women; mean age 51.7 ± 15.6 years) and 303 community dwellers aged 20 years or older (57.8% women; mean age 43.9 ± 15.2 years). Exploratory and confirmatory factor analysis was performed to examine the factor structure of the HAS-J. Cronbach’s α and McDonald’s ω were then used to test internal consistency. To examine the scale’s validity, we determined correlations between the HAS-J and other indexes and compared HAS-J scores between insomnia patients and community dwellers. We also compared HAS-J scores between two community-dweller groups (normal and poor sleepers) and two insomnia patient groups (with and without alleviation after treatment).ResultsFollowing exploratory and confirmatory factor analysis, a 20-item measure emerged comprising three factors: “Introspectiveness and Reactivity,” “Neuroticism,” and “Insomnia.” Confirmatory factor analysis showed a generally good fit for the model of the three-factor structure suggested by the exploratory factor analysis loadings (χ2 (163) = 327.423, (p < 0.001), CFI = 0.914, GFI = 0.872, AGFI = 0.835, RMSEA = 0.067). In insomnia patients, internal consistency indicated sufficient reliability of the HAS-J. Correlation analysis showed weak to moderate positive correlations of the HAS-J score with other indexes, indicating concurrent validity of the HAS-J. All HAS-J subscale scores were significantly higher in insomnia patients than in community dwellers. Additionally, the total score in patients with alleviation of insomnia was comparable to that in poor sleepers and significantly higher than that in normal sleepers.ConclusionsThis study demonstrated the reliability and validity of the HAS-J, indicating that it is useful as a clinical scale of hyperarousal. The high level of hyperarousal in insomnia patients who were assessed to be in remission by the Insomnia Severity Index suggests a risk of insomnia recurrence in these patients.