Health Status Scale Research Articles

The role of inflammation on the association between apathy and motoric‐cognitive outcomes

AbstractBackgroundRecent literature indicates that apathy is associated with poor cognitive outcomes in community dwelling older adults, including motoric cognitive risk syndrome (MCR), a predementia syndrome defined by subjective cognitive complaints and slow gait. The role of biological markers in the association between apathy and motoric‐cognitive outcomes has not been established. The objectives of this study were to 1) examine the association between inflammation and apathy and 2) to evaluate the moderating effect of inflammation on the association between apathy and motoric‐cognitive outcomes.MethodWe measured apathy in 347 community dwelling older adults enrolled in the Central Control of Mobility in Aging study using an apathy scale score derived from confirmatory factory analysis of the Geriatric Depression Scale Long Form. We conducted cross‐sectional analyses of the following: the association between IL‐6 and CRP with apathy and the moderating effect of IL‐6 on the association between apathy and MCR and slow gait, using logistic regression and linear regression models, respectively. Linear associations were reported using β‐coefficients, while logistic associations were reported using odds ratio (OR) with 95% confidence intervals (CI), adjusting for age, gender, general health status and depression scale score.ResultlogIL‐6 but not logCRP was associated with apathy, in adjusted models (β=.037, 95% CI: .002‐.072, p=.04). Apathy was not significantly associated with MCR at cross‐section (OR: 0.48, 95% CI: .08‐2.97, p=.43), but apathy was significantly associated with gait velocity (β=‐14.45, 95% CI: ‐24.89 ‐ 4.01, p=.01). IL‐6 was associated with gait velocity (β=‐4.48, 95% CI: ‐7.42 ‐ 1.53, p=.003) and moderated the association between apathy and gait velocity by a change in β of 14.5%.ConclusionWe found that IL‐6, but not CRP was associated with apathy in a cohort of community dwelling older adults. Furthermore, IL‐6 moderated the association between apathy and gait velocity, a risk factor for dementia. Apathy was not associated with MCR at cross‐section, despite being associated with incident MCR in prior studies, suggesting that apathy is an early predictor of motoric‐cognitive decline.

Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post Hoc Analyses from MAIA

Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post Hoc Analyses from MAIA

Social Mental Health during COVID-19 Pandemic in Iran: A cross-sectional study among the general population of Razavi Khorasan province, Iran

Background: The potential impact of the novel coronavirus pandemic on social mental health has become a great concern and the current situation can cause different mental disorders. According to the importance of mental health, we performed this study to evaluate the mental health status of the general population of Iran in Razavi Khorasan province. Methods: The online survey was conducted and made available for the general population of Razavi Khorasan through the snowball sampling technique within a week. the demographic information, contact history with COVID-19, and physical symptoms history of COVID-19 were collected by the survey. To maintain the population's mental health status, the Depression, Anxiety, and Stress Scale (DASS-21) were used. Filling the online survey by a maximum of two members of a family was considered to reduce the risk of bias. Results: Finally, 461 responders from Razavi Khorasan province were included in this study. In total, 41.8% of responders investigated the depression symptoms, 32.1% were in anxiety mood and 34.5% had stress symptoms. The ratio of men to women was approximately 1:2. Most responders were in the of 30-40 years and the most frequent marital status was being single. Families with 3-5 members were organized the 81.5% of responders. Near one-third of the studied population was in bachelor as educational status. Conclusion: According to our study paying attention to the general population’s mental health status is important during the COVID-19 pandemic and conducting protocols to prevent or reduce the risk of mental disorders that can be caused by the current situation.

Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma Treated with Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone: Update of the Phase 3 MAIA Trial

Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma Treated with Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone: Update of the Phase 3 MAIA Trial

Usefulness of Smartphone Apps for Improving Nutritional Status of Pancreatic Cancer Patients: Randomized Controlled Trial.

BackgroundApproximately 80% of pancreatic ductal adenocarcinoma (PDAC) patients suffer from anorexia, weight loss, and asthenia. Most PDAC patients receive chemotherapy, which often worsens their nutritional status owing to the adverse effects of chemotherapy. Malnutrition of PDAC patients is known to be associated with poor prognosis; therefore, nutritional management during chemotherapy is a key factor influencing the outcome of the treatment. Mobile apps have the potential to provide readily accessible nutritional support for patients with PDAC.ObjectiveWe aimed to evaluate the efficacy of a mobile app–based program, Noom, in patients receiving chemotherapy for PDAC.MethodsWe prospectively enrolled 40 patients who were newly diagnosed with unresectable PDAC from a single university-affiliated hospital in South Korea, and randomly assigned them into a Noom user group (n=20) and a non-Noom user group (n=20). The 12-week in-app interventions included meal and physical activity logging as well as nutritional education feedback from dietitians. The non-Noom user group did not receive any nutrition intervention. The primary outcomes were the changes in the nutritional status and quality of life (QoL) from the baseline to 12 weeks. The secondary outcomes included the changes in the skeletal muscle index (SMI) from the baseline to 12 weeks. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Patient-Generated Subjective Global Assessment (PG-SGA) were used as paper questionnaires to assess the QoL and nutritional status of the patients. Intention-to-treat and per-protocol analyses were conducted. Regarding the study data collection time points, we assessed the nutritional status and QoL at the baseline (T0), and at 4 (T1), 8 (T2), and 12 (T3) weeks. Abdominal computed tomography (CT) imaging was conducted at the baseline and after 8 weeks for tumor response and SMI evaluation. The skeletal muscle area (cm2) was calculated using routine CT images. The cross-sectional areas (cm2) of the L3 skeletal muscles were analyzed.ResultsBetween February 2017 and January 2018, 48 patients were assessed for eligibility. Totally 40 patients with pancreatic cancer were included by random allocation. Only 17 participants in the Noom user group and 16 in the non-Noom user group completed all follow-ups. All the study participants showed a significant improvement in the nutritional status according to the PG-SGA score regardless of Noom app usage. Noom users showed statistically significant improvements on the global health status (GHS) and QoL scales compared to non-Noom users, based on the EORTC QLQ (P=.004). The SMI decreased in both groups during chemotherapy (Noom users, 49.08±12.27 cm2/m2 to 46.08±10.55 cm2/m2; non-Noom users, 50.60±9.05 cm2/m2 to 42.97±8.12 cm2/m2). The decrement was higher in the non-Noom user group than in the Noom user group, but it was not statistically significant (-13.96% vs. -3.27%; P=.11).ConclusionsThis pilot study demonstrates that a mobile app–based approach is beneficial for nutritional and psychological support for PDAC patients receiving chemotherapy.Trial RegistrationClinicalTrials.gov NCT04109495; https://clinicaltrials.gov/ct2/show/NCT04109495.

Serum KIM-1, NGAL, and NAG Levels and Correlation with the Diagnostic Value in Patients with Fracture Traumatic Shock.

Traumatic shock is the most common cause of serious adverse outcomes in patients with severe traumatic diseases such as fractures, and some studies here have shown that the main cause of death from traumatic shock is the impairment of organ function that occurs after shock. In this study, we explored the role of serum kidney injury molecule-1 (KIM-1), neutrophil gelatin-related lipid transporter protein (NGAL), and N-acetyl-β-D-glucosidase (NAG) levels in evaluating and diagnosing the condition of patients with fracture traumatic shock based on the goal of contributing to the clinical diagnosis of the patient's condition as soon as possible and taking measures to alleviate its progress. 96 patients with fracture traumatic shock were included in the study as the observation group and 58 healthy examiners as the control group, and the observation group was divided into 69 cases in the mild-moderate group and 27 cases in the severe group according to the Acute Physiology and Chronic Health Status Scale (APACHE-II). In this study, we detected and analyzed the differences in serum KIM-1, NGAL, and NAG levels between the observation group and the control group and the observation group with different disease levels. We found that the observation group was significantly higher than the control group, and the severe patients were higher than the mild to moderate patients, and we observed that serum KIM-1, NGAL, and NAG are significantly correlated with the condition of patients with fracture traumatic shock after further analysis using the Pearson model. In addition, the diagnostic value of receiver operating characteristic curve analysis showed that the AUC of serum KIM-1 for the diagnosis of fracture traumatic shock was 0.755, the AUC of serum NGAL was 0.750, the AUC of serum NAG was 0.772, and the AUC of the combination of the three indicators was 0.915. The results of this study thus suggest the possibility of serum KIM-1, NGAL, and NAG as clinical indicators for evaluating the condition of patients with fracture traumatic shock and the possibility of a combined test of serum KIM-1, NGAL, and NAG for diagnosing the condition.

Prevalence and Risk Factors of Depression in Turkish Geriatric Population: Gender Differences in a Field Study

"Background: Aging is associated with increased morbidity, mortality, hospitalization, and loss of functional status related to common mental disorders in the elderly. The aim of this study is the need to identify new and unmet problem areas in geriatric depression and develop efficient interventions for gender-based differences. Methods: The cross-sectional, field-based study was conducted with 2269 participants. The nurses serving in primary health care facilities collected data. The Questionnaire consisted of socio-demographic characteristics, illnesses, medications, Non-communicable diseases (NCDs), EQ-5D, General Health Status (GHS), Geriatric Depression Scale (GDS) and Visual Analog Scale for health status (VAS) was collected in face-to-face interviews at the participants' homes. Results: In the study, the mean age was 73.3 (6.7), 50.3% were male. Of the older individuals' 71.8% had a chronic disease and 62.2% used at least one medication. The prevalence of depression was 31.2%. Women had a higher prevalence (35.6%) of severe depression than men (26.7%). Age, living alone, being single, being unemployed, having a chronic disease, and perception of poor health condition was associated with high depressive scores in the elderly whereas education, working status, and having a chronic disease were important factors in men. Conclusions: Depression evaluation in primary health care is an important part of geriatric health check-ups. The incidence of depressive symptoms significantly changes according to gender. Gender-based strategies like increasing the retirement age for men and providing post-retirement job opportunities can be effective in reducing depression. "

The effect of demographic, clinical, and pathological data on quality of life in rectum cancer.

The aims of the current study are to describe the quality of life among patients with rectal cancer and to determine the clinical and demographic correlation that influences the quality of life of rectal cancer patients. In this study, 50 patients with rectal cancer treated in the Radiation Oncology Department of Kayseri CityEducation and Research Hospital were included. Ethics committee approval was received for the study. Data collection form was used to determine the demographic and clinicopathological characteristics of the patients. To assess the quality of life, the European Committee of Cancer Treatment and Organization Quality of Life Scale (EORTC QLQ-C30) question-answer scale was used. The data were collected by interviewing the patients face to face. Mann-Whitney U and Kruskal-Wallis tests were used to analyze the data. Spearman correlation analysis was performed to reveal the relationship between dependent variables. As a result of this study, 52% of patients were 65years and older and 54% were male patients. The most common surgery was low anterior resection and the most common type of pathology was adenocarcinoma. According to American Cancer Committee (AJCC) 7th edition 2009 staging, 80% stage 3 was the most common. In EORTC C30 Cancer Quality of Life Scale Functional Scale Subscale, the highest score is from the physical function and the lowest score is from the emotional function. In the symptom scale subscale, the most common symptom was nausea/vomiting. Performance status (ECOG) was found to be significantly associated with T stage, N stage, TNM stage, and symptom scores. There was a moderately significant positive correlation between symptom scales and global health status scales (ρ = 0.51; p < 0.001). There was a perfectly positive and significant relationship between symptom scales and functional scales (ρ = 0.83; p < 0.001). As a result of this study we conducted, it was observed that rectal cancer patients decreased performance status and increased symptoms in the presence of advanced disease. Accordingly, it was found that the quality of life of the patient decreased.

The Use of Herbal Therapy to Improve the Quality of Life among Cancer Patients in the Southern Region of Peninsular Malaysia

Objective:To investigate the impact of herbal therapy on the quality of life (QoL) among cancer patients and to evaluate the relationship of QoL with age, gender, cancer stage, cancer type, and history of conventional treatment.Methodology:A prospective study was targeted on cancer patients receiving herbal therapy from a Traditional and Complementary Medicine (T&CM) clinic in a public hospital from 1st January 2016 to 31st August 2018. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30) was distributed to the patients prior to herbal therapy (baseline) and after the sixth and twelfth week of herbal therapy. Socio-demographic and clinical data were collected and analyzed using SPSS version 16. Results:The majority of the patients were females (60.0%) and were from the Chinese ethnic group (77.4%) with a mean age of 58.72 ± 12.17 years. Approximately 42.4% of patients were in advanced cancer stages at the time of study and 60.7% of patients had undergone radiotherapy before receiving herbal therapy. The most commonly prescribed herbs were Bai Hua She She Cao (90.6%) and Zhen Ren Huo Ming Yin (57.6%). Significant differences in mean score were observed in global health status, overall functional scales, and symptom scales after the sixth and twelfth week of receiving herbal therapy. QoL in terms of global health status and overall functional scales improved with higher scores while symptom scales recorded a lower score after twelve weeks of receiving herbal therapy in the T&CM clinic. Herbal therapy has a significant effect (p < 0.05) on the improvement of QoL of cancer patients. However, gender, cancer stage, cancer type, age, history of radiotherapy, and history of chemotherapy has no effect (p > 0.05). Conclusion:Herbal therapy did improve the QoL of cancer patients in the southern region of Peninsular Malaysia.

Effectiveness of an Awareness Programme on Drug Compliance among People with Selected Chronic Diseases

The compliance to drug treatment leads to the prevention of deaths from the disease. Nurses play a very important role in the adherence to treatment by patients. The study aims at exploring the level of drug compliance among people with chronic illness (hypertension and diabetes mellitus), factors that influence the decision of the person and evaluates an awareness programme on the identified issues. The study used a Survey and Evaluative Approach with survey and quasiexperimental design. Purposive samplingwas used to collect data from Marne, Athrady, Herebettu which are rural areas and Malpe area of Manipal which is an urban area. Among 23535 population surveyed a total of 1286 (602 urban and 684 rural) samples with the disease and undergoing treatment were identified. 328(184 urban and 144 rural) people who were not complying to drugs were given awareness programme. The tools used were Demographic performa, Morisky scale, Srivastava Socioeconomic scale, scale for Health status (SF-36) and a scale to assess factors. The study was based on the Rosentoch’s, Becker and Maiman’s Health Belief model.

The effects of complex decongestive therapy on kinesthetic sense of hands, upper extremity function, and quality of life in patients with breast cancer-related lymphedema.

Objectives This study aims to investigate the effect of complex decongestive therapy (CDT) on the kinesthetic sense of hands, upper extremity function, and the quality of life in patients with breast cancer-related lymphedema (BCRL). Patients and methods Between August 2018 and August 2019, total of 50 women with BCRL (mean age: 56.5±9.6 years; range, 36 to 71 years) were included in the study. Kinesthetic sense of the hand, upper extremity function (Disabilities of the Arm, Shoulder and Hand [DASH]), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire [EORTC QLQ-C30]), and arm volume of all patients were evaluated before and after the treatment. All patients received CDT for 20 sessions for 1 h over a total of four weeks. Results A statistically significant decrease in the volume of the involved extremity was observed after the treatment (p<0.001). There was a significant decrease in the symptom score (p<0.001) and a significant improvement in the general health status and functional scales of the EORTC QLQ-C30 (p<0.001 and p=0.012, respectively). The DASH scores and visual and kinesthetic sense scores of the patients significantly improved after the treatment (p=0.016, p=0.008, and p<0.001, respectively). Conclusion Our study results show that BCRL is a serious complication which may lead to impairment in the kinesthetic sense of hand and upper extremity function with the increased arm volume. The CDT is an effective and safe method not only to achieve significant volume reduction in the extremities, but also to achieve favorable results in managing these problems.

Quality of life, functioning, and symptoms in patients with previously treated locally advanced or metastatic urothelial carcinoma from EV-301: A randomized phase 3 trial of enfortumab vedotin versus chemotherapy.

4539 Background: In EV-301, a randomized, open-label phase 3 study (NCT03474107), enfortumab vedotin (EV), a Nectin-4–directed therapy, significantly prolonged median overall survival by ̃3.9 months and reduced the risk of death by 30% compared with standard chemotherapy (SC; docetaxel, paclitaxel, or vinflunine) in patients with previously treated locally advanced/metastatic urothelial carcinoma. Understanding patient perspectives and experiences is important to further contextualize the benefits/risks of EV. Here, we report key prespecified quality-of-life (QoL) endpoints, a secondary objective of EV-301. Methods: Patients completed the validated European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, on Day 1 of each week for the first 12 weeks, and then every 12 weeks until discontinuation. The QLQ-C30 assessed functional domains, symptom scales/items, financial impact, and overall health/QoL. Descriptive statistics were used to summarize instrument compliance rates and scores; mixed model repeated measures were used to evaluate changes from baseline over time. Logistic regressions were conducted to assess confirmed improvement rates, defined as clinically meaningful improvement (predefined per domain) over two subsequent visits. Results: Of the 608 randomized patients (EV, n = 301; SC, n = 307), 77.3% were male, median age was 68 (range: 30-88), and 30.9% had liver metastasis. Questionnaire compliance rates at baseline were ̃90% in both groups; during the study, average rates were 70.2% (EV) and 66.9% (SC). Baseline QLQ-C30 scores were similar between groups. At Week 12, scores on the global health status (GHS) scale were similar between groups (EV: -2.8, SC: -5.0; P=.2429), but SC was associated with numerically greater deterioration and more variability in QoL over the first 12 weeks. Patients receiving EV had significant reduction in pain symptoms (EV: -5.62, SC: +0.11; adjusted difference: -5.73, P&lt;.05), but significant worsening of appetite loss (EV: +8.55, SC: +1.26; adjusted difference: 7.29, P&lt;.05) compared with SC. Other symptom scores were not significantly different between groups. Higher proportions of patients on EV vs SC had significant confirmed improvements across all functioning domains (role, physical, emotional, social, cognitive), GHS, and several symptom scales (pain, fatigue, dyspnea, constipation). The greatest difference in improvement was reported for pain (EV: 51.6%, SC: 28.8%; OR = 2.76[1.81, 4.22]). Conclusions: Compared with SC, patients receiving EV had numerically less deterioration and variability in QoL during the first 12 weeks of treatment. More patients in the EV group had improvements over SC in 10 of 15 QLQ-C30 domains; improvement in pain showed the largest benefit. Clinical trial information: NCT03474107.

Comparing the properties of the EQ-5D-5L and EQ-5D-3L in general population in Iran.

Little information exists on properties of EQ-5D-5L (the 5L hereafter) compared to the EQ-5D-3L (the 3L hereafter) measures in the context of Iran. This study aims to compare the measurement properties of the two versions of the EQ-5D (the 3L vs. the 5L) using data obtained from general population in Iran. A total of 886 adults aged 18 years and above from September to November 2020 participated in this cross-sectional analysis. The required data collected using self-administered and-standard questionnaire and multistage sampling method was used to select the samples. The 3L and 5L measures compared in terms of celling effect, distribution and redistribution pattern, feasibility, convergent validity, know-groups validity and informativity. From September to November 2020, 886 adults (mean aged=44.6 years; 55% male and 87.1% married) included in the study. The study indicated that the 5L had lower celling effects compared to the 3L (45% vs. 46%). A better convergent validity and known-groups validity was found for the 5L version compared to the 3L and significantly stronger association found between the 5L measure with both the Visual Analogue Scale and the 5-point health status scale. The 5L index score showed higher relative efficiency (RE) in 9 of 11 condition (mean RE=1.36). Compared to the 3L, the 5L classification system had higher Shannon index (H') in all dimensions: mobility (0.52 vs. 0.40), self-care (0.23 vs. 0.20), usual activities (0.61 vs. 0.47), pain/discomfort (1.19 vs. 0.89) and anxiety/depression (1.22 vs. 0.47). The study demonstrated that the measurement properties of 5L version in terms of celling effects, convergent validity, known-groups validity, RE and informativity similar or better than the 3L among general population; suggesting the use of 5L in the context of Iran. Hence, we suggested the use of the 5L in economic evaluation, clinical and public health studies in Iran.

Evaluating the Depression, Anxiety, Stress, and Predictors of Psychological Morbidity Among COVID-19 Survivors in Mashhad, Iran

Background: The outbreak of coronavirus disease 2019 (COVID-19) pandemic has led to public panic and psychological problems. In this regard, few studies have reported the post-discharge mental health status of COVID-19 survivors. Objectives: This study aimed to evaluate the mental health status of COVID-19 survivors and determine the risk factors of adverse psychological outcomes. Methods: This cross-sectional study consisted of 188 COVID-19 survivors discharged from hospital. Data were recorded using social media applications. To evaluate the mental health status, Hospital Anxiety and Depression Scale (HADS) and Depressive Anxiety and Stress Scale 42 (DASS-42) were used. Ordinal regression with a logit link was used to assess the simultaneous effect of variables. Results: The mean age of participants was 56.4 ± 9.6 years, and the majority of patients were male (62.2%). According to HADS, 81 (43.1%) and 24 (12.8%) patients suffered from anxiety and depression, respectively. Using DASS-42, we reported at least a mild degree of depression [23 (12.2%)], anxiety [20 (10.6%)], and stress [74 (39.4%)] among the discharged patients. Depression, anxiety, and stress were significantly associated with length of hospital stay (P &lt; 0.05). In addition, there was a direct association between stress and patients’ number of children (β = 0.38, P = 0.02). Conclusions: Depression, anxiety, and stress are relatively high among COVID-19 survivors. Length of hospital stay and number of children were identified as the predisposing factors for adverse psychological outcomes.

Glasgow Coma Scale: Linguistic-Cultural Adaptation of the Russian Version

INTRODUCTIONDetermination of the degree of depression of consciousness in patients with brain damage upon admission to the intensive care unit and intensive therapy is a primary task. In order to carry out a quick and at the same time sufficiently complete assessment of this kind, in 1974 neurosurgeons Graham Teasdale and Bryan Jennett from the University of Glasgow developed an algorithm consisting of a sequential series of tests in the form of eye opening, speech and motor responses, called Glasgow Coma Scale. This scale has received worldwide recognition and for many decades has been the main one for determining the state of consciousness in the most severe patients with brain damage. The absence of a validated version of this scale complicates its application in Russia, and the use of currently available versions that have not passed all the necessary stages of validation distorts the originally intended meaning of the scale and does not allow obtaining reliable clinical results when examining patients with acute impairment of consciousness.AIM OF STUDYDevelopment of the official Russian­language version of the Glasgow Coma Scale, taking into account linguistic and cultural characteristics (1st stage of the validation study).MATERIAL AND METHODSThe staff of Center for Validation of Health Status Questionnaires and Scales in Russia, Research Center of Neurology obtained consent from G. Teasdale to validate Glasgow Coma Scale in Russia. Two Russian­speaking professional certified translators in the field of medicine performed a direct translation of the original English­language scale, and a reverse translation was carried out by native speakers with a medical education. Pilot study was performed in 15 patients with acute impairment of consciousness, two meetings of the expert committee were held (before and after pilot study).RESULTSBased on the results of the first meeting of the expert commission, a linguistic and cultural adaptation of the text of the scale was carried out. During the pilot testing of the researchers did not have difficulties in understanding and interpreting instructions. As a result, the second meeting of the expert commission was held and the final Russian­language version was approved, which is presented in this article and is available on the website of Center for Validation of Health Status Questionnaires and Scales in Russia, Research Center of Neurology.CONCLUSIONFor the first time, the Russian language version of the Glasgow Coma Scale was officially presented and recommended for use both in clinical and research practice in Russia and other Russian speaking countries. The next publication will highlight the result of assessing the psychometric properties (reproducibility, inter­expert agreement and sensitivity) of the Russian­language version of the scale.

Probable REM Sleep Behavior Disorder Is a Risk Factor for Symptom Progression in Parkinson Disease.

Background: The literature is conflicting on whether rapid eye movement sleep behavior disorder (RBD) is associated with more rapid progression of Parkinson disease (PD).Objective: We aimed to determine (1) how stable probable RBD (pRBD) is over time and (2) whether it predicts faster PD progression.Methods: We evaluated participants in the Parkinson's Disease Biomarker Project (PDBP) who were prospectively assessed every 6–12 months with a series of motor, non-motor, disability, and health status scales. For aim 1, we calculated the incidence and disappearance rates of pRBD and compared stability of pRBD in PD with control subjects. For aim 2, we developed multiple regression models to determine if pRBD at baseline influenced the rate of change or average value at 48 months of 10 outcome variables.Results: We found that pRBD was a less stable diagnosis for PD than controls. In pRBD+ subjects, the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score progressed 2.78 points per year faster (p < 0.01), MDS-UPDRS total score progressed 3.98 points per year faster (p < 0.01), a global composite outcome (GCO) worsened by 0.09 points per year faster (p = 0.02), and Parkinson's Disease Questionnaire (PDQ-39) mobility score progressed 2.57 percentage points per year faster (p < 0.01). The average scores at 48 months were 8.89 (p = 0.02) and 14.3 (p = 0.01) points higher for pRBD+ in MDS-UPDRS part III and total scores, respectively.Conclusions: Our study confirms that pRBD detected at the start of a study portends more rapid progression of PD. Knowing this could be useful for enriching clinical trials with fast progressors to accelerate discovery of a disease modifying agent.

POS-799 EFFECT OF DARATUMUMAB/BORTEZOMIB/CYCLOPHOSPHAMIDE/DEXAMETHASONE ON RENAL FUNCTION AND HRQOL IN PATIENTS WITH NEWLY-DIAGNOSED AL AMYLOIDOSIS WITH RENAL INVOLVEMENT: RESULTS FROM THE PHASE 3 ANDROMEDA STUDY

Systemic light chain (AL) amyloidosis is a rare disease characterized by amyloid fibril deposits, most commonly in the heart and kidneys; the extent of organ involvement impacts clinical outcomes. There are currently no approved treatments for AL amyloidosis. Although treatments for multiple myeloma (MM), including bortezomib, cyclophosphamide, and dexamethasone (VCd), have been shown to improve outcomes, more effective therapies are needed. Daratumumab (DARA) is an anti-CD38 monoclonal antibody approved as monotherapy and in combination with other agents for the treatment of MM. In the phase 3 open-label ANDROMEDA trial (NCT03201965), patients with newly diagnosed AL amyloidosis treated with DARA subcutaneous (DARA SC) + VCd (DARA-VCd) had improved objective hematologic and organ response rates over 6 cycles of treatment. Here, we present change in renal function and patient-reported outcomes (PROs) in patients with baseline (BL) renal involvement from ANDROMEDA. Patients (N=388) with newly diagnosed AL amyloidosis with measurable hematologic disease, ≥1 involved organ, estimated glomerular filtration rate (eGFR) ≥20 mL/min, and absence of symptomatic MM were randomized 1:1 to DARA-VCd or VCd for 6 28-day cycles; thereafter, patients in the DARA-VCd group received DARA SC alone every 4 weeks up to 24 cycles. The percentage of patients with renal improvement (≥30% decrease in proteinuria or drop in proteinuria below 0.5g/24 hour in the absence of ≥25% decrease in eGFR) was also determined. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) improvement in global health status (GHS) and fatigue scale scores were secondary study endpoints. Here we report PRO results for Cycles 1–6 (assessed on Day 1 of each cycle). Analyses were performed in the subset of patients with renal involvement, defined as 24-hour urine protein >0.5g/day, predominantly albumin. Change from BL at various time points was analyzed using a mixed-effects model with repeated measures with patients as a random effect, and BL value, treatment group, time (weeks), and treatment-by-time interaction as fixed effects. For selected single items of the EORTC QLQ-C30, the distribution of responses and the number and percentage of patients with ≥1-point improvement from BL were summarized at each time point. Of the total population in ANDROMEDA, 115 and 114 patients in the DARA-VCd and VCd groups had renal involvement, respectively; 117 and 113 patients were evaluable for renal response. At 6 months, 53.8% of DARA-VCd and 27.4% of VCd patients had a renal response (P<0.0001). GHS (Figure) and fatigue scores remained stable with DARA-VCd but worsened with VCd by Cycle 3; the greatest between-group differences were observed at Cycle 5. At BL, 56–85% of patients reported shortness of breath, feeling weak or tired by ‘a little’ or more (Table). More DARA-VCd than VCd patients experienced ≥1-point improvements in these symptoms (Table). DARA-VCd increased renal response, with results suggestive of improvement in fatigue-related parameters, such as shortness of breath, feeling tired, or weak, in AL amyloidosis patients with renal involvement.

Comparison of Nutritional Intake and Dietary Behaviors in Overweight/Obese and Nonobese University Students: A School-Based Study

Objective: This study was conducted to determine of nutritional intake and dietary behaviors in overweight/obese and non-obese university students. Methods: The sample of this descriptive comparative study consisted of 220 students randomly selected among the university students who were divided into two groups as overweight / obese and non-obese. Data were collected using a daily nutrition log, anthropometric measurements and questionnaire. Results: Of the 220 students admitted to our study, 110 were overweight/obese and 110 were non-obese. Obesity was correlated with the reason for skipping meals, smoking, amount of physical activity (p&amp;lt;0.05). Overweight/obese students have a high scores of Perceived Health Status scale and a low Self-Efficacy to Regulate Eating Habits scale (p=0.00). The scores of the Health Promotion Lifestyle Profile Nutrition scale and the Perceived Health Status scale of the non-smoking students were significantly high (p&amp;lt;0.05). The Health Promotion Lifestyle Profile Exercise scale was significantly higher in the students with high frequency of physical activity (p=0.00). Overweight/obese students had high daily energy, fat, cholesterol, and sodium intake, while all students consumed insufficient amounts of key nutrients like fiber, folate, and calcium (p=0.00). Conclusions: These results emphasize the need to provide students health promotion programs should be implemented at universities to and raise young people’s awareness about making healthy choices that will affect their future.

Quality of life in patients with mycosis fungoides and Sézary syndrome undergoing low-dose total skin electron beam therapy with or without maintenance therapy

Quality of life in patients with mycosis fungoides and Sézary syndrome undergoing low-dose total skin electron beam therapy with or without maintenance therapy

The Effectiveness of Qigong in Managing a Cluster of Symptoms (Breathlessness-Fatigue-Anxiety) in Patients with Lung Cancer: A Randomized Controlled Trial.

Background and Purpose:Qigong is used by cancer patients, but its effect is not adequately evaluated to date. The aim of this study was to investigate the effects of Qigong for the management of a symptom cluster comprising fatigue, dyspnea, and anxiety in patients with lung cancer.Methodology:A total of 156 lung cancer patients participated in this trial, and they were randomized to a Qigong group (6 weeks of intervention) or a waitlist control group receiving usual care. The symptom cluster was assessed at baseline, at the end of treatment (primary outcome), and at 12 weeks, alongside measures of cough and quality of life (QOL).Results:There was no significant interaction effect between group and time for the symptom cluster overall and for fatigue and anxiety. However, a significant trend towards improvement was observed on fatigue (P = .004), dyspnea (P = .002), and anxiety (P = .049) in the Qigong group from baseline assessment to the end of intervention at the 6th week (within-group changes). Improvements in dyspnea and in the secondary outcomes of cough, global health status, functional well-being and QOL symptom scales were statistically significant between the 2 groups (P = .001, .014, .021, .001, and .002, respectively).Conclusion:Qigong did not alleviate the symptom cluster experience. Nevertheless, this intervention was effective in reducing dyspnea and cough, and improving QOL. More than 6 weeks were needed, however, for detecting the effect of Qigong on improving dyspnea. Furthermore, men benefited more than women. It may not be beneficial to use Qigong to manage the symptom cluster consisting of fatigue, dyspnea, and anxiety, but it may be effective in managing respiratory symptoms (secondary outcomes needing further verification in future research). Future studies targeting symptom clusters should ensure the appropriateness of the combination of symptoms.Trial registration:ClinicalTrials.gov Identifier: NCT02977845. Registered November 30, 2016. https://clinicaltrials.gov/ct2/show/NCT02977845?term=Qigong&cond=Lung+Cancer&draw=2&rank=1