Symptom-related Quality Of Life Research Articles

Quality of life in disease-free survived patients with early-stage extranodal nasal-type NK/T-cell lymphoma after definitive intensity-modulated radiotherapy: a cross-sectional study of 310 cases

PurposeRadiotherapy is a critical treatment for early-stage extranodal nasal-type NK/T-cell lymphoma (ENKTL) and has yielded favorable survival outcomes. However, their postradiotherapy quality of life (QOL) has not been investigated. Here, we conducted a cross-sectional study to assess the QOL of ENKTL patients with disease-free survival after definitive radiotherapy and to identify factors associated with QOL and treatment optimization.MethodsThis cross-sectional study included 310 patients with stage I–II ENKTL of the upper aerodigestive tract (UADT) who had received simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) with a consistent design and achieved disease-free survival. The median postradiotherapy time was 47.2 months (range, 3.1–115.7). The EORTC QLQ-H&N35 questionnaire was used to assess symptom-related QOL, and nine additional items were added to incorporate nasal, optical, and aural-related symptoms. The scores indicate the severity of the symptoms.ResultsThe most common postradiotherapy symptoms among patients with ENKTL were nose problems (49.7%), dry mouth (44.8%), tooth problems (41.3%), sensory problems (32.6%), and less sexuality (25.8%). Tooth problems had the highest average score of 18.6, which is still acceptable. The severity of these symptoms decreased over time and reached a plateau in the second year after radiotherapy. Multivariable regression analysis showed that whole-neck irradiation was an independent predictive factor for xerostomia (P = 0.013, OR = 1.114), while age > 60 years was a predictive factor for lower sexuality (P < 0.001, OR = 1.32).ConclusionThe QOL of patients with early-stage ENKTL after radiotherapy was favorable, and most symptoms improved over time. Radiotherapy was correlated with specific symptoms, which may suggest a direction for further improvement in SIB-IMRT.

Somatoform Symptoms and Functional Impairments During Middle Childhood

Abstract: Theoretical Background: Studies have shown that attachment is associated with somatoform symptoms in childhood, yet factors that mediate the association need to be explored. Objective: To examine emotion regulation strategies as a mediator between insecure attachment dimensions and somatoform symptoms and symptom-related impairments in quality of life (QoL). Method: A total of 221 fourth-grade school children in Germany completed the SOMS-KJ, FEEL-KJ, and ECR-RC. Results: In the path model, attachment-related anxiety was positively associated with social support seeking and emotional expression, while attachment-related avoidance was negatively associated with these, yet positively associated with emotional suppression. Both emotional suppression and social support seeking were positively associated with somatoform symptoms and symptom-related impaired QoL. Discussion and Conclusion: Differential pathways exist from insecure attachment dimensions to increased somatoform symptoms, indicating that children require specialized emotion competence training.

Pelvic floor symptoms and symptom-related quality of life in the mothers of children with cerebral palsy: a pilot cross-sectional study.

Pelvic floor symptoms may occur in women with low back pain due to dysfunction of the spinal stabilization muscles. Low back pain is the most common musculoskeletal problem experienced by the mothers of children with cerebral palsy (CP). Therefore, our aim in this study was to examine pelvic floor symptoms and symptom-related quality of life in the mothers of children with CP. The study included 48 mothers of children with CP (n = 23) or without neurodevelopmental problems (n = 25). The mothers' pelvic floor symptoms and symptom-related quality of life were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7). PFDI-20 and PFIQ-7 scores did not differ between the two groups of mothers (p > .05). Additionally, moderately significant positive correlations were found between the age of the child with CP and duration of carrying and the PFDI-20 (r = 0.419, p = .047) and PFIQ-7 (r = 0.427, p = .042) scores. Pelvic floor symptoms and symptom-related quality of life in the mothers of children with CP were similar to those in the mothers of children without neurodevelopmental problems. As the age of the child with CP and duration of carrying increase, the urinary symptoms and urinary and colorectoanal symptoms-related quality of life in their mothers may worsen.

Gastric emptying and myoelectrical activity testing in children with esophageal atresia: A pilot study.

Abnormalities of gastric function in children with esophageal atresia (EA) could potentially contribute to gastrointestinal symptoms and reduced quality of life (QOL). Therefore, we aimed to determine the feasibility and clinical usefulness of gastric function testing in children with EA. The validated PedsQL Gastrointestinal Symptoms Questionnaire (PedsQL-GI) was completed to assess gastrointestinal symptoms and symptom-related QOL. Gastric emptying and gastric myoelectrical activity were studied using 13C-gastric emptying octanoic acid breath test (13C-GEBT) and surface electrogastrography (EGG). Correlations between 13C-GEBT and EGG parameters and PedsQL-GI scores were investigated. Fifteen patients (four males) were included (median age: 6 [3.0-8.5] years). Mean PedsQL-GI scores as reported by the children were comparable to the healthy population. However, parents reported a diminished QOL. Gastric function tests (gastric emptying and/or surface EGG) showed abnormalities in 12 patients (80%). Patients with abnormal slow waves showed abnormal gastric emptying coefficientmore often. There was no significant association between 13C-GEBT nor EGG results and PedsQL-GI scores. 13C-GEBT and EGG can be used to evaluate gastric function in patients with EA. Abnormal gastric function tests were present in 80% of our cohort. However, abnormal gastric function did not significantly correlate with reported gastrointestinal symptom-related QOL.

Quality of life with ribociclib versus abemaciclib as first-line treatment of HR+/HER2- advanced breast cancer: a matching-adjusted indirect comparison.

A cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + endocrine therapy is recommended as first-line treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). Quality of life (QoL) is an important endpoint that affects treatment decisions. Understanding the relevance of CDK4/6i treatment on QoL is gaining importance given use in earlier treatment lines for ABC and an emerging role in treating early breast cancer in which QoL may be more impactful. In the absence of head-to-head trial data, a matching-adjusted indirect comparison (MAIC) permits comparative efficacy between trials. In this analysis, patient-reported QoL for MONALEESA-2 [ribociclib + aromatase inhibitor (AI)] and MONARCH 3 (abemaciclib + AI) was compared using MAIC with a focus on individual domains. An anchored MAIC of QoL comparing ribociclib + AI versus abemaciclib + AI was performed using data from the European Organization for Research and Treatment of Cancer quality of life questionnaire (QLQ)-C30 and BR-23 questionnaires. Individual patient data from MONALEESA-2 and published aggregated data from MONARCH 3 were included in this analysis. Time to sustained deterioration (TTSD) was calculated as the time from randomization to a ⩾10-point deterioration with no later improvement above this threshold. Patients from the ribociclib (n = 205) and placebo (n = 149) arms of MONALEESA-2 were matched with patients from the abemaciclib (n = 328) and placebo (n = 165) arms of MONARCH 3. After weighting, baseline patient characteristics were well balanced. TTSD significantly favored ribociclib versus abemaciclib in appetite loss [hazard ratio (HR), 0.46; 95% confidence interval (CI), 0.27-0.81], diarrhea (HR, 0.42; 95% CI, 0.23-0.79), fatigue (HR, 0.63; 95% CI, 0.41-0.96), and arm symptoms (HR, 0.49; 95% CI, 0.30-0.79). TTSD did not significantly favor abemaciclib compared with ribociclib in any functional or symptom scale of the QLQ-C30 or BR-23 questionnaires. This MAIC indicates that ribociclib + AI is associated with better symptom-related QoL than abemaciclib + AI for postmenopausal patients with HR+/HER2- ABC treated in the first-line setting. NCT01958021 (MONALEESA-2) and NCT02246621 (MONARCH 3).

Factors influencing Patient’s Quality of Life (QoL) Undergoing Cancer Treatment- a Descriptive Exploratory study

Background &amp; Objectives:: Cancer is the major health problem in developed and developingcountries.With the advent of treatment like chemotherapy and radiotherapy, survival rates of manycancers have increased, but patient may experience side effects from the disease itself or from treatmentwhich can eventually hinder patient’s quality of life. The present study was planned to assess thequality of life among cancer patient undergoing cancer treatment in selected hospitals of Gangtok,East Sikkim. Methods: Investigator adopted the descriptive exploratory research design, where 100cancer patients, within the age group of 18 years or above, either hospitalized or attending day careservices and undergoing chemotherapy were selected through purposive sampling technique. The datawas collected through english version of European Organization for Research and Treatment of Cancer(EORTC C-30) for which validity and reliability was established. Results: Majority (42%) of thecancer patients were in the age group of ≥59 years and 89% had received chemotherapy, ranging from0 to 3 cycles (39%). Majority diagnosed with carcinoma of the gastro intestinal tract (45%) followedby reproductive tract (30%). The cancer patients undergoing cancer treatment had average quality oflife. General health/quality of life was significantly different depending on age, place of habitat, therapyhistory, type of chemotherapy received (p&lt; 0.05), functional quality of life with type of family, type ofchemotherapy (p&lt; 0.05), symptom-related quality of life with marital status, educational status, type offamily and diagnosis of site (p&lt; 0.05) and financial difficulty with sex of the cancer patients (p&lt; 0.05).Conclusions: This study shows cancer patient had average quality of life. Thus is necessary to identifyfactors influencing quality of life among cancer patients to increase the effects of intervention to reducehelplessness and explaining power to improve health promotion behavior.

Prevalence of Fatigue in Patients with Head and Neck Cancer Submitted to Radio- Chemotherapic Treatment: Systematic Review

Introduction: Fatigue is considered a reversible change of biological and psychic functions originated from the organism’s unbalance. In patients with cancer, fatigue is usually reported as one of the most frequent symptoms and is defined as chronic mainly in cases when metastases impair the daily life activities significantly. Objective: This work aimed to evaluate the prevalence of fatigue in patients with head and neck cancer submitted to radiochemotherapy treatment. Method: The standardized methodology was PRISMA and PICO anagram. LILACS, PubMed, Google Scholar and SciELO databases were searched applying the descriptors “fatigue”; “cancer”; “prevalence”; “head and neck cancer. Scientific articles in English published between 2009 and 2019 were included. Five studies have evaluated fatigue isolated occurrence through the questionnaire Brief Fatigue Inventory (BFI) and variables collected by interviews utilized Piper Fatigue Scale. Results: Of the 243 patients, 70% showed fatigue. In another 13 studies, fatigue has been assessed along with other symptoms by applying questionnaires already validated in literature. There was a significant increase on fatigue scores as well as in quality of life related symptoms, for instance, pain, stress, and depression for the 1,908 patients interviewed. Conclusion: Fatigue’s occurrence in the population of head and neck patients was high and commonly related to other symptoms such as pain, sleep disorders, lack of appetite, dyspnea, emotional stress, and depression.

Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol

IntroductionAn electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden,...

Health-related quality of life after laparoscopic repair of giant paraesophageal hernia: how does recurrence in CT scan compare to clinical success?

BackgroundComputed tomography (CT) is widely used in the diagnosis of giant paraesophageal hernias (GPEH) but has not been utilised systematically for follow-up. We performed a cross-sectional observational study to assess mid-term outcomes of elective laparoscopic GPEH repair. The primary objective of the study was to evaluate the radiological hernia recurrence rate by CT and to determine its association with current symptoms and quality of life.MethodsAll non-emergent laparoscopic GPEH repairs between 2010 to 2015 were identified from hospital medical records. Each patient was offered non-contrast CT and sent questionnaires for disease-specific symptoms and health-related quality of life.ResultsThe inclusion criteria were met by 165 patients (74% female, mean age 67 years). Total recurrence rate was 29.3%. Major recurrent hernia (> 5 cm) was revealed by CT in 4 patients (4.3%). Radiological findings did not correlate with symptom-related quality of life. Perioperative mortality occurred in 1 patient (0.6%). Complications were reported in 27 patients (16.4%).ConclusionsSuccessful laparoscopic repair of GPEH requires both expertise and experience. It appears to lead to effective symptom relief with high patient satisfaction. However, small radiological recurrences are common but do not affect postoperative symptom-related patient wellbeing.

Quality of Life following Allogeneic Stem Cell Transplantation for Patients Age >60 Years with Acute Myelogenous Leukemia.

This study of patients with acute myelogenous leukemia (AML) age ≥60 years analyzed the association between patients' performance indices-Hematopoietic Stem Cell Transplantation Comorbidity Index (HCT-CI), Karnofsky Performance Score (KPS), and European Society for Blood and Marrow Transplantation (EBMT) risk score-before undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) and quality of life (QoL), quantified using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant Scale (FACT-BMT), in the first year after allo-HSCT. Over a period of 7 years, 48 evaluable patients underwent reduced-intensity conditioning allo-HSCT. The median patient age was 65 years (range, 60 to 74 years), with 2-year and 5-year overall survival (OS) of 65.8% and 52.3%, respectively. A significant improvement across all QoL scores was observed over the 12 months post-HSCT. An HCT-CI of 0 was associated with improved general QoL (FACT-G) score at 6 months compared with patients with an HCT-CI of 1 to 2 (P= .032). At 12 months post-HSCT, a pretransplantation HCT-CI ≥3 was correlated with lower QoL scores across the domains (symptom-related QoL [FACT-TOI], P= .036; FACT-G, P= .05; BMT-related QoL [FACT-BMT], P= .036). A pretransplantation KPS score of 100 versus 80 to 90 was predictive of improved QoL at 6 months post-HSCT (FACT-TOI, P=.009; FACT-G, P= .001; FACT-BMT, P= .002) but not at 1 year post-HSCT. We demonstrate that KPS and HCT-CI can predict QoL in the early post-transplantation period, with a favorable overall survival in a selected cohort of AML patients age ≥60 years.

P039 CLINICAL HYPNOSIS IN PEDIATRIC CROHN’S DISEASE: A RANDOMIZED CONTROLLED TRIAL

Abstract Background Crohn’s disease (CD) is a chronic, immune-mediated condition associated with abdominal pain, psychological comorbidities, and reduced quality of life (QoL), even in remission. Clinical hypnosis, involving focused relaxation and therapeutic suggestion, is helpful for irritable bowel syndrome, pain, and anxiety, and may have anti-inflammatory effects. Study Aims: To implement hypnosis as an adjunctive therapy for adolescents with CD. To assess the impact on QoL, abdominal pain, psychosocial measures, and disease activity compared to standard care. Methods Forty 12–18 year-olds with CD diagnosed &amp;gt;3 months prior randomized to hypnosis intervention (HI) or waitlist control (WC). HI receive one in-person hypnosis session focused on enhancing comfort, calm, and energy; education on self-hypnosis; audio recordings for 8 weeks home practice. Assessments at 8 and 16 weeks. Primary outcome: disease-specific health-related (HR) QoL Impact III, single-item QoL modified Cantril Scale, parent-proxy HRQoL PedsQL 4.0. Secondary outcomes: Anxiety, Depressive Symptoms, Sleep Disturbance (PROMIS pediatric short forms); abdominal pain frequency and intensity; Pain Beliefs Questionnaire short form (PBQ-SF); school absences; healthcare utilization; Physician’s Global Assessment (PGA); Pediatric Crohn’s Disease Activity Index. With n=40, 80% power to detect 13-point difference in Impact III. Two-sided Wilcoxon test used to compare differences from baseline to follow up and between groups. Results Demographics: 40 participants enrolled February-May 2019. 50% female. 15.8 y ± 2. PGA: 28 quiescent, 6 mild, 3 moderate, 3 not documented. 18, 8, and 13 of 40 with moderate-severe depressive symptoms, anxiety, and sleep disturbance, respectively. 25 of 40 with abdominal pain in the past week. WC with poorer systemic symptom-related QoL by Impact III (p=0.01) and greater depressive symptoms (p=0.03) compared to HI. Post-Intervention (8 Weeks): In HI and not in WC, significant improvement was noted in parent-reported QoL (p=0.006; Figure 1), maximum abdominal pain intensity (p=0.01, Figure 2), PBQ-SF subdomain emotion-focused coping efficacy (p=0.04), and school absences (p=0.03). 50% of HI participants used self-hypnosis at least 3–4 times per week and tended to have greater QoL improvement than those who practiced less. Participants described improvement in stress, anxiety, and sleep, though corresponding measures were unchanged. 16-week outcomes and disease activity pending. Conclusions Adolescents with CD have pain, reduced QoL, and psychological impairment despite inactive disease. Hypnosis is an acceptable, feasible, and promising complementary therapy in CD and may improve QoL, abdominal pain, coping efficacy, and school attendance. Additional RCTs with longer follow up, objective disease activity assessment, and measures to improve compliance are warranted.

The Prevalence of Gastrointestinal Symptoms Depends on Disease Duration and Gastrointestinal Tract Region in Patients with Type 2 Diabetes

Background/Aims: We aimed to unravel how symptoms related to gastrointestinal (GI) dysfunction impair quality of life (QoL) in patients with diabetes mellitus (DM). Methods: We enrolled 134 outpatients with type 2 DM and 16 non-DM. In DM patients, mean age was 64.7 years, mean body mass index (BMI) 24.7 kg/m2, mean glycated hemoglobin (HbA1c) 7.1%, and mean DM duration 13.7 years. In non-DM, mean age was 66.6 years and mean BMI was 25.2 kg/m2. GI symptom-related QoL was determined using the Izumo scale, based on five factors, i.e., heartburn, gastralgia, postprandial fullness, constipation and diarrhea. The sum of scores obtained for the three questions in each domain was calculated, and subjects with a score of 5 or higher were considered to be symptomatic with impaired QoL. JMP Clinical version 5.0 was used for all statistical analyses. Results: In DM patients, constipation was much greater than non-DM, diarrhea was somewhat higher, other symptoms did not increase significantly. In DM, lower abdominal symptoms were found to be more frequent than those affecting the upper abdomen. Diabetic duration and medications showed associations with GI symptoms. We identified differences in peak prevalences of the five symptoms. Gastralgia and total GI symptoms peaked at a diabetes duration of 15-19 years. Heartburn and postprandial fullness tended to increase with disease duration. Constipation and diarrhea showed bimodal peaks, with the first early and the second late in the disease course. Finally, GI symptoms showed clustering that reflected the region of the GI tract affected, i.e., constipation and diarrhea had similar frequencies. Conclusions: Our study highlights the importance of questioning patients about QoL impairment due to abdominal symptoms, especially in the early and the late periods of diabetes. The heterogeneous nature of the underlying GI symptoms, including medication usage, should be taken into consideration when managing patients with T2DM. Disclosure M. Fujishiro: Research Support; Self; Johnson &amp; Johnson Services, Inc. A. Kushiyama: Research Support; Self; Teijin Pharma Limited, Sanwa Kagaku Kenkyusho Co., Ltd., Kowa Pharmaceutical Co., Ltd, StaGen. Consultant; Self; RIZAP. H. Yamazaki: None. T. Yamamotoya: None. T. Kikuchi: None. H. Sakoda: None. R. Suzuki: Research Support; Self; Daiichi Sankyo Company, Limited, Kyowa Hakko Kirin Co., Ltd.. Other Relationship; Self; MSD K.K., Novo Nordisk Pharma Ltd., Daiichi Sankyo Company, Limited, Eli Lilly Japan K.K. T. Kadowaki: Consultant; Self; Novo Nordisk A/S, AstraZeneca, Merck Sharp &amp; Dohme Corp.. Research Support; Self; Kissei Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Sanofi, Kyowa Hakko Kirin Co., Ltd., Novo Nordisk A/S, Astellas Pharma, Daiichi Sankyo Company, Limited, Takeda, Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceutical Co., Ltd., Merck Sharp &amp; Dohme Corp., Nippon Boehringer Ingelheim Co. Ltd.. Speaker's Bureau; Self; Astellas Pharma, AstraZeneca, Merck Sharp &amp; Dohme Corp., Ono Pharmaceutical Co., Ltd., Takeda, Eli Lilly and Company, Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk A/S.

Quality of life and diabetes mellitus among diabetic adult patients in an urban slum area

Background: Quality of life studies help us to develop models that tend to improve the overall health status of the patients. The objective was to study effect of diabetes mellitus on quality of life of diabetic adult patients in an urban slum area. Methods: A hospital based cross sectional study was carried out among 64 eligible known cases of diabetes for a period of three months. For recording questions related to quality of life, questionnaire which was validated was used. The data was expressed as mean and standard deviation. Results: The overall quality of life (role limitation due to physical health) was not much affected as the average scores are above 3.5 which indicates “better quality of life”. The quality of life for heavy activities was slightly affected due to diabetes. But the patients were able to do the mild activities compared to heavy physical activities. Diabetes has affected their quality of life. But in terms of fatigue it has not been much affected. Overall the mean of this symptom related quality of life, was better. This may be due to good glycemic control. Comparatively frequent urination bothered the diabetic patients. Conclusions: Diabetes has some impact on the quality of life of patients as seen from the study.

Gastrointestinal symptom prevalence depends on disease duration and gastrointestinal region in type 2 diabetes mellitus.

AIMTo unravel relationships between gastrointestinal (GI) symptoms impairing quality of life (QOL) and clinical profiles of diabetes mellitus (DM) patients.METHODSWe enrolled 134 outpatients with type 2 DM. Mean age was 64.7 years, mean body mass index was 24.7 kg/m2, mean glycated hemoglobin was 7.1%, and mean DM duration was 13.7 years. GI symptom-related QOL was determined using the Izumo scale, based on five factors, i.e., heartburn, gastralgia, postprandial fullness, constipation and diarrhea. The sum of scores obtained for the three questions in each domain was calculated, and subjects with a score of 5 or higher were considered to be symptomatic with impaired QOL. JMP Clinical version 5.0 was used for all statistical analyses.RESULTSLower abdominal symptoms were found to be more frequent than those affecting the upper abdomen. Diabetic duration and medications showed associations with GI symptoms. We identified differences in peak prevalences of the five symptoms. Gastralgia (P = 0.02 vs 10-14 years) and total GI symptoms (P = 0.01 and P = 0.02 vs 5-9 years and 10-14 years, respectively) peaked at a diabetes duration of 15-19 years. Heartburn (P = 0.004) and postprandial fullness (P = 0.03) tended to increase with disease duration. Constipation and diarrhea showed bimodal peaks, with the first early and the second late (e.g., P = 0.03 at 15-19 years vs 10-14 years for diarrhea) in the disease course. Finally, GI symptoms showed clustering that reflected the region of the GI tract affected, i.e., constipation and diarrhea had similar frequencies (P < 0.0001).CONCLUSIONOur study highlights the importance of questioning patients about QOL impairment due to abdominal symptoms, especially in the early and the late periods of diabetes.

Abdominal symptoms in cystic fibrosis and their relation to genotype, history, clinical and laboratory findings.

Background & aimsAbdominal symptoms (AS) are a hallmark of the multiorgan-disease cystic fibrosis (CF). However, the abdominal involvement in CF is insufficiently understood and, compared to the pulmonary manifestation, still receives little scientific attention. Aims were to assess and quantify AS and to relate them to laboratory parameters, clinical findings, and medical history.MethodsA total of 131 patients with CF of all ages were assessed with a new CF-specific questionnaire (JenAbdomen-CF score 1.0) on abdominal pain and non-pain symptoms, disorders of appetite, eating, and bowel movements as well as symptom-related quality of life. Results were metrically dimensioned and related to abdominal manifestations, history of surgery, P. aeruginosa and S. aureus colonization, genotype, liver enzymes, antibiotic therapy, lung function, and nutritional status.ResultsAS during the preceding 3 months were reported by all of our patients. Most common were lack of appetite (130/131) and loss of taste (119/131) followed by abdominal pain (104/131), flatulence (102/131), and distention (83/131). Significantly increased AS were found in patients with history of rectal prolapse (p = 0.013), distal intestinal obstruction syndrome (p = 0.013), laparotomy (p = 0.022), meconium ileus (p = 0.037), pancreas insufficiency (p = 0.042), or small bowel resection (p = 0.048) as well as in patients who have been intermittently colonized with P. aeruginosa (p = 0.006) compared to patients without history of these events. In contrast, no statistically significant associations were found to CF-associated liver disease, chronic pathogen colonization, lung function, CF-related diabetes, and nutritional status.ConclusionAs the complex abdominal involvement in CF is still not fully understood, the assessment of the common AS is of major interest. In this regard, symptom questionnaires like the herein presented are meaningful and practical tools facilitating a wider understanding of the abdominal symptoms in CF. Furthermore, they render to evaluate possible abdominal effects of novel modulators of the underlying cystic fibrosis transmembrane (conductance) regulator (CFTR) defect.

Brain Microstructural Correlates of Cognitive Dysfunction in Clinically and Biochemically Normal Hepatitis C Virus Infection

This study examined correlates of the brain's neurocognitive performance among clinically and biochemically normal adult patient with hepatitis C virus (HCV). We hypothesized that anti-HCV positive individuals would demonstrate structural brain abnormalities and neurocognitive dysfunction as well as the changes in cell component and extracellular space in the white matter regions of brain in asymptomatic HCV infection by using diffusion tensor tractrography (DTT) metrics. Anti-HCV positive patient (n=40), and healthy controls (n=31), fulfilling inclusion criteria (incidentally detected anti-HCV positive) and able to provide informed consent were screened and recruited for the study. All these subjects and controls underwent subjective assessment of their quality of life related symptoms, neuropsychometric tests (NPT) and magnetic resonance imaging. The patients were subjected to neuroimaging as well as psychological testing. There was no significant difference in basic laboratory parameters in these two groups. Independent t-test reveals significantly lower neuropsychological functioning as compared to healthy control. A significantly decreased FA values and myoinsitol were observed in HCV subjects on sensory, inferior longitudinal fascicules, and STR fiber bundles as compared to healthy control. Bivariate correlation analysis reveals that neuropsychological scores are significantly positive. Our result show that HCV positive individuals would demonstrate structural brain abnormalities and neurocognitive dysfunction as well as the changes in cell component and extracellular space in the white matter regions of brain in asymptomatic HCV infection by using DTT metrics.

Balloon Eustachian Tuboplasty in children.

Endonasal ballon dilatation of the Eustachian tube (BET) is a promising treatment for Eustachian tube dysfunction with encouraging results over the last years in adults. In addition, in children, single studies demonstrated promising results, but revealed the necessity for broader and additional studies. Our retrospective analysis presents outcomes with BET in children with chronic obstructive dysfunction of the Eustachian tube, showing resistance to the conventional therapy after adenotomy with paracentesis or grommets (ventilation tubes). The data of 52 children, having undergone BET from April 2011 to April 2016, were retrospectively evaluated. Most children in our study presented middle ear effusion (47%), adhesive (21%), chronic otitis media (13%), or recurrent acute otitis media (11%). In 24 (37%) children, we combined BET with a paracentesis, in 5 (8%) patients with a tympanoplasty type I and in 3 (5%) patients with a type III. All children were assessed using an audiogram, tympanometry, and tubomanometry (50mbar) before and after BET. In addition, we evaluated the results of the Lübecker questionnaire, which we performed before and after BET. The childrens' ear-related and quality of life-related symptoms, such as pressure equalization, ear pressure, hearing loss, pain and limitation in daily life, and satisfaction pre- and postoperatively, were analyzed. In the majority of patients, we could see an improvement in the ear pressure, hearing loss, limitation in daily life, and satisfaction with recurrent inflammations, underlined by better outcomes in the tubomanometry and the tympanogram. BET in children is a safe, efficient, and promising method to treat chronic tube dysfunction, especially as a second line treatment, when adenotomy, paracentesis, or grommets failed before.

Myeloproliferative Neoplasm Quality of Life (MPN-QOL) Study Group: Interim Results from the MPN Experimental Assessment of Symptoms By Utilizing Repetitive Evaluation (MEASURE) Trial

Background:Myeloproliferative neoplasms (MPN) including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF) are clonal hemopathies characterized by burdensome symptom profiles and impaired quality of life. Few studies have evaluated patient-reported outcomes during treatment with non-experimental pharmacological regimens.Aims:The Myeloproliferative Neoplasm Quality of Life (MPN-QOL) Study Group aims to objectively quantify MPN symptom severity, frequency and quality of life at baseline and throughout treatment with non-experimental therapies utilizing the Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS; JCO 2012). In this abstract, we provide updated results for the prospective international cohort trial currently in active enrollment: the MPN Experimental Assessment of Symptoms by Utilizing Repetitive Evaluation (MEASURE) trial.Methods:This study aims to recruit 180 international ET, PV, and MF (including primary MF and post-ET or post-PV MF) patients receiving non-experimental medical therapy and/or phlebotomy. Patients complete the MPN-SAF for seven consecutive days at enrollment and repeat the survey for an additional seven consecutive days between 90 days and six months. Patients also complete the European Organisation for Research and Treatment of Cancer (EORTC) and M.D. Anderson Symptom Inventory (MDASI) instruments at enrollment and on the first day of the second assessment. At visits, physicians acquired demographic, laboratory, physical examination, and radiographic data. Descriptive statistics were used to summarize data.Results:Clinical DataThe MEASURE trial opened for enrollment in 2012 and remains in recruitment phase with 15 participating international sites. To date, 39 patients have been enrolled and 25 have completed both study visits. Participants include ET (28%), PV (24%), and MF (48%; 50% primary MF, 8% post-ET, 42% post-PV) patients. The majority of patients are male (64%) and of expected age (mean 69.3, range 39-89) for the disorders. Seventeen percent had prior thrombosis, 9% required red blood cell transfusion, and none reported prior splenectomy or hemorrhage. Mean hematologic measures included hemoglobin 13.2 g/dL, WBC count 11.4 x109/L, ANC 8.5 x109/L, and platelets 514 x109/L.Therapies received prior to enrollment included aspirin (n=16), hydroxyurea (n=11), phlebotomy (n=8), warfarin/clopidogrel/anticoagulation (n=8), erythropoietin (n=2), and interferon (n=1). The most common current MPN therapies were hydroxyurea (n=9), aspirin (n=9), interferon (n=4), and phlebotomy (n=2).Symptom AssessmentIn comparing MPN-SAF TSS mean symptom scores, all symptoms except bony pain improved between the first and second visits, including fatigue, early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, fever, weight loss, and overall quality of life (Figure1). Total MPN-SAF TSS scores improved from a mean of 32.3 to 25.9. On the EORTC, mean scores for physical, role, emotional, and social functioning improved from the first to the second visit (Figure 2). Cognitive functioning showed a slight decline. Global health status measure improved from 60.2 to 72.9. On the MDASI, symptom severity scores decreased from 3.6 to 2.8 from the first to second visit (Figure 3). Symptom distress measure decreased from 4.1 to 3.0.Discussion:Interim results from the MEASURE trial demonstrate that standard, non-experimental treatment regimens offer improvement in quality of life-related symptoms on multiple patient-reported survey instruments including the MPN-SAF TSS, EORTC QLQ-C30, and MDASI. Updated data including symptom correlations and mutational analysis to be presented at the 2016 ASH conference. [Display omitted] [Display omitted] [Display omitted] DisclosuresRoss:Novartis Pharmaceuticals: Honoraria, Research Funding; BMS: Honoraria. Radia:Novartis: Honoraria; Pfizer: Honoraria. McMullin:Novartis: Honoraria, Speakers Bureau. Cargo:Novartis: Honoraria; Celgene: Honoraria, Research Funding. Sekhar:Novartis: Research Funding. Mesa:Gilead: Research Funding; CTI Biopharma: Research Funding; Galena: Consultancy; Ariad: Consultancy; Incyte: Research Funding; Novartis: Consultancy; Celgene: Research Funding; Promedior: Research Funding.

Danish Urogynaecological Database.

The Danish Urogynaecological Database is established in order to ensure high quality of treatment for patients undergoing urogynecological surgery. The database contains details of all women in Denmark undergoing incontinence surgery or pelvic organ prolapse surgery amounting to ~5,200 procedures per year. The variables are collected along the course of treatment of the patient from the referral to a postoperative control. Main variables are prior obstetrical and gynecological history, symptoms, symptom-related quality of life, objective urogynecological findings, type of operation, complications if relevant, implants used if relevant, 3–6-month postoperative recording of symptoms, if any. A set of clinical quality indicators is being maintained by the steering committee for the database and is published in an annual report which also contains extensive descriptive statistics. The database has a completeness of over 90% of all urogynecological surgeries performed in Denmark. Some of the main variables have been validated using medical records as gold standard. The positive predictive value was above 90%. The data are used as a quality monitoring tool by the hospitals and in a number of scientific studies of specific urogynecological topics, broader epidemiological topics, and the use of patient reported outcome measures.

A Systematic Review of Relaxation, Meditation, and Guided Imagery Strategies for Symptom Management in Heart Failure.

Pain, dyspnea, fatigue, and sleep disturbance are prevalent and distressing symptoms in persons with advanced heart failure. Although many lifestyle and self-care interventions have been developed to control heart failure progression, very few studies have explored treatments exclusively for symptom palliation. Cognitive-behavioral strategies may be effective treatment for these symptoms in advanced heart failure. A systemic review was conducted to describe the effect of cognitive-behavioral strategies on pain, dyspnea, fatigue, and sleep disturbance in patients with heart failure. CINAHL, Medline, and PsychINFO were searched from inception through December 2014. Articles were selected for inclusion if they tested a cognitive-behavioral strategy using a quasi-experimental or experimental design, involved a sample of adults with heart failure, and measured pain, dyspnea, fatigue, sleep disturbance, or symptom-related quality of life. The 2 authors evaluated study quality, abstracted data elements from each study, and synthesized findings. Thirteen articles describing 9 unique studies met criteria and were included in the review. Five studies tested relaxation strategies, 3 tested meditation strategies, and 1 tested a guided imagery strategy. Of the 9 studies, 7 demonstrated some improvement in symptom outcomes. Relaxation, meditation, guided imagery, or combinations of these strategies resulted in less dyspnea and better sleep compared with attention control or usual care conditions and reduced pain, dyspnea, fatigue, and sleep disturbance within treatment groups (pretreatment to posttreatment). Symptom-related quality of life was improved with meditation compared with attention control and usual care conditions and improved pre- to post-guided imagery. Studies exploring cognitive-behavioral symptom management strategies in heart failure vary in quality and report mixed findings but indicate potential beneficial effects of relaxation, meditation, and guided imagery on heart failure-related symptoms. Future research should test cognitive-behavioral strategies in rigorously designed efficacy trials, using samples selected for their symptom experience, and measure pain, dyspnea, fatigue, and sleep disturbance outcomes with targeted symptom measures.