Poorer Quality Of Life Scores Research Articles

Body Image and Quality of Life and Brace Wear Adherence in Females With Adolescent Idiopathic Scoliosis.

Background:Clinical evidence regarding the ability of braces to decrease the risk of curve progression to surgical threshold in patients with adolescent idiopathic scoliosis (AIS) continues to strengthen. Unfortunately, there is still a great deal of uncertainty regarding the impact of brace wear on psychosocial well-being or the impact of psychological well-being on brace wear adherence. The purpose of this study is to evaluate psychosocial well-being, in particular body image and quality of life (QOL), and brace wear adherence in female AIS patients undergoing brace treatment.Methods:The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) was a multicenter, controlled trial using randomized and preference assignments into an observation or brace treatment group. BrAIST patients were skeletally immature adolescents diagnosed with AIS having moderate curve sizes (20 to 40 degrees). Patients in the bracing group were instructed to wear a thoracolumbosacral orthosis, at least 18 h/d. Scores on the Spinal Appearance Questionnaire and the PedsQL4.0 Generic Scales from 167 female BrAIST patients who were randomized to brace treatment (n=58) and patients who chose brace treatment (n=109) were analyzed.Results:At baseline and at 12 months, no differences were found between the least-adherent brace wear group (<6 h/d) and most-adherent brace wear group (≥12 h/d) patients in terms of major curve, body image, and QOL. In the most-adherent group, poorer body image scores were significantly correlated with poorer QOL scores at baseline, at 6 months, and at 12 months but not at 18 months. In general, body image scores and QOL scores were not significantly correlated in the least-adherent group. When comparing patients that had a ≥6 degree increase of their major curve between baseline and 12 months to patients that did not, there were no significant differences in body image or QOL scores.Conclusions:For females adolescents with AIS, body image and QOL do not have a significant impact on brace wear adherence and are subsequently not significantly impacted by brace wear.Level of Evidence:Level II—therapeutic (prospective comparative study).

A clinical profile of hemophilia patients and assessment of their quality of life in Western Uttar Pradesh, India: An observational study

Objective: To describe the clinical profile of hemophiliac patients and their quality of life (QoL) in Western Uttar Pradesh. Materials and Methods: This was an observational cross-sectional study. Patients of all age groups with hemophilia admitted in the medicine and pediatrics ward for factor/fresh frozen plasma transfusion or having history of such type of transfusion were consecutively enrolled. A detailed clinical history was elicited from the accompanying parent/guardian. The HAEMO-QoL questionnaire was used for the assessment of QoL of the patients. Results: Out of the total 71 hemophilia patients, 66.2% (51/77) were >18 years of age. Type A hemophilia was observed in 88.3% (68/71) patients. Majority of the patients had severe hemophilia (80.5%). The family history and joint involvement were present in 58.4% and 77.9% of the patients, respectively. Knee joint was observed to be as the target joint among 57.1% of the patients. 76.6% of the patients had joint swelling, resulting in compromised joint movement. Bleeding occurred in soft tissues and joints in 62.3% and 15.6% of the patients, respectively. The patients had poor QoL scores. Overall, hepatitis B and C infection were observed in 6.5% and 9.1% of the patients, respectively. Orthophysiotherapy was needed in 22/26 (84.6%) patients. Conclusion: The severe type of haemophilia Type A was more common than mild and moderate types. The study suggests that important determinants for QoL in haemophilia patients are availability of factor concentrate from the clinical perspective and social and psychological support to ensure a holistic care approach.

Assessment of health related quality of life of elderly diabetic patients attending urban primary health care facility - a cross sectional study

Background: ‘Ageing’ is associated with decline in many body functions; and lifetime exposure to health hazards has an impact on elderly who contend with the “double burden” of non-communicable diseases such as Diabetes Mellitus, Hypertension, etc., Indian elderly are more prone for chronic disease like Type 2 Diabetes Mellitus and hence measuring health related quality of life among them is essential to plan interventions at primary care settings. Methods: A cross sectional study was conducted among 400 elderly patients aged 60 years and above with Type 2 Diabetes Mellitus attending outpatient department of urban primary health care facility of Belagavi city. The quality of life was assessed using modified WHO-QOL BREF questionnaire under 4 domains viz. physical health, psychological, social relationship and environment. Results: Among the participants 46% were men and 54% were women. The total scores for all the domains overall ranged between 15.75 and 73.5 with a mean score of 40.26 and a standard deviation of 11.14. The mean scores in physical, psychological, social and environmental scores were 44.21±8.50, 40.27±8.83, 36.69±14.62 and 39.9±12.58 respectively. Hypertension though the most common morbidity noted, but did not have statistically significant difference in any domains (P<0.05). Conclusions: The health related quality of life among elderly diabetics was lower in social domain as compared to other domains. Socio-economic status and Education levels were associated with poor quality of life scores. Emphasis on quality of life assessment of elderly diabetic patients is imperative in comprehensive management.

Quality of life and coping strategies in Lebanese Multiple Sclerosis patients: A pilot study

Coping strategies used by Multiple Sclerosis patients play a key role in adjusting to the disease and affect their overall quality of life. This relationship has been investigated in developed countries, but none has been studied in developing ones such as Lebanon. Factors including barriers to health care delivery, economic pressure and political instability influence which coping strategies are used and often increases the use of negative coping mechanisms. The current pilot study explored the association between different coping strategies with quality of life and depression, anxiety, fatigue and social support in 34 Lebanese Multiple Sclerosis patients. Results indicated that Multiple Sclerosis patients using positive coping strategies had significantly higher scores of quality of life (U=46, p=.038) and social support (U=33.5, p=.011), and lower depression (U=44, p=.030) and anxiety levels (U=46.5, p=.038) as compared to those using negative coping strategies. Specifically, escape avoidance coping strategy was associated with poor quality of life scores (r=−.609, p<.0001) and high levels of depression (r=.534, p=.001), anxiety (r=.530, p=.001), and fatigue (r=.401, p=.019). Comprehensive assessment of Multiple Sclerosis taking into account coping strategies is needed to develop proper therapeutic interventions which increase quality of life. Future studies are required to confirm these results.

Health-related quality of life after first-line anti-cancer treatments for advanced non-small cell lung cancer in clinical practice.

This study attempted to compare changes in the Quality-of-Life (QoL) scores after three different first-line anti-cancer treatments for advanced non-small cell lung cancer (NSCLC) in a real-world clinical setting. From May 2011 to December 2013, we prospectively measured the QoL scores of patients with locally advanced or metastatic NSCLC using the World Health Organization Quality-of-Life-Brief (WHOQOL-BREF) questionnaire. Each QoL measurement was matched by age and sex with one healthy referent from the National Health Interview Survey. Dynamic changes in patients' QoL scores and major determinants were repeatedly assessed by construction of a mixed-effects model to adjust for possible confounders. A total of 336 patients with 577 QoL measurements related to first-line anti-cancer treatments were enrolled. Performance status was the most important predictor of QoL scores in all domains after controlling for potential confounders. With age- and sex-matched healthy subjects as the reference, patients treated with gemcitabine+platinum showed significantly lower scores in multiple physical and psychological domain items in the WHOQOL-BREF. However, pemetrexed+platinum and gefitinib/erlotinib affected patients' QoL scores in 'energy/fatigue' and 'daily activities' with smaller magnitudes, and the scores appeared to improve after 3-4months of treatment. Patients receiving gemcitabine+platinum as first-line anti-cancer treatment for advanced NSCLC experienced relatively poor QoL scores throughout treatment course. Studies to develop a real-time computerized system automatically updating the mixed-effects model for QoL to facilitate participatory clinical decision making by physicians, patients, and their families merit further research.

Psychosocial concerns of cancer patients in Singapore.

Psychosocial needs are high among cancer patients, and screening for these is recognized as integral to quality cancer care. This study identified the psychosocial needs of cancer patients at their first visit at a hematology-oncology clinic. Fifty-four new consecutive patients completed the Distress Thermometer and the Problem List, the Hospital Anxiety and Depression Scale, and the EuroQol Quality of Life Scale at their first visit to plan for chemotherapy. Data were analyzed with SPSS. Analyses revealed that participants had an average of 2.8 ± 2.3 problems, with 82% having psychosocial needs. Emotional concerns formed the top four psychosocial needs of the cohort (worry 46%, fears 26%, nervousness 26%, sadness 24%), with the fifth being a practical concern (insurance/finance 22%). The former were more frequent among 41- to 50-year-olds and significantly correlated with distress scores. Practical concerns were significantly correlated with depressive symptoms. Family concerns were more significant in women. The overall score on the Problem List correlated with distress, anxious symptomatology and poorer quality of life scores. Distress and psychosocial needs are high in cancer patients even at an early stage prior to chemotherapy. Attention to these needs is crucial as they cause significant distress and affect the patient's quality of life.

Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: Results from the ACOSOG Z4032 (Alliance) multicenter randomized trial

BackgroundPrior studies have suggested that low baseline quality-of-life (QOL) scores predict worse survival in patients undergoing lung cancer surgery. However, these studies involved average-risk patients undergoing lobectomy. We report QOL results from a multicenter trial, American College of Surgeons Oncology Group Z4032, which randomized high-risk operable patients to sublobar resection (SR), or SR with brachytherapy, and included longitudinal QOL assessments. MethodsGlobal QOL, using the 36-item Short-Form Health Survey (SF36), and the dyspnea score from the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) scale, was measured at baseline, 3, 12, and 24 months. SF36 physical component summary (PCS) and mental component summary (MCS) scores were standardized and adjusted for age and gender normals, with scores <50 indicating below-average health status. SOBQ scores were transformed to a 0-100 (poor-excellent) scale. Aims were to: (1) determine the impact of baseline scores on recurrence-free survival, overall survival, and 30-day adverse events (AEs); and (2) identify subgroups (surgical approach, resection type. tumor location, tumor size, respiratory function) with a ≥10-point decline or improvement in QOL after SR. ResultsTwo hundred twelve eligible patients were included. There were no significant differences in baseline QOL scores between arms. Median baseline PCS, MCS, and SOBQ scores were 42.7, 51.1, and 70.8, respectively. There were no differences in grade-3+ AEs, overall survival, or recurrence-free survival in patients with baseline scores ≤median versus >median values, except for a significantly worse overall survival for patients with baseline SOBQ scores ≤median value. There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3, 12, or 24 months. Further comparison combining the 2 arms demonstrated a higher percentage of patients with a ≥10-point decline in SOBQ scores with segmentectomy compared with wedge resection (40.5% vs 21.9%, P = .03) at 12 months, with thoracotomy versus video-assisted thoracic surgery (VATS) (38.8% vs 20.4%, P = .03) at 12 months, and T1b versus T1a tumors (46.9% vs 23.5%, P = .020) at 24 months. A ≥10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy (16.5% vs 3.6%, P = .02). ConclusionsIn high-risk operable patients, poor baseline QOL scores were not predictive for worse overall or recurrence-free survival, or for higher risk for AEs following SR. VATS was associated with improvement in physical function at 3 months, and improved dyspnea scores at 12 months, lending support for the preferential use of VATS when SR is undertaken.

Long-term Outcomes in Severe Lower Urinary Tract Symptoms in Men Undergoing Robotic-assisted Radical Prostatectomy

To address a major concern driving treatment intervention, we studied incontinence and urinary quality of life (QOL) before and after robotic-assisted radical prostatectomy (RARP). In men with severe lower urinary tract symptoms (LUTS), this is the first observational study analyzing short- and long-term urinary outcomes of RARP. RARP was performed on 665 patients by 1 surgeon from 2002 to 2007. Men returned preoperative and postoperative self-reported American Urological Association symptom score (AUAss), urinary QOL, and continence (pad usage) questionnaires. Men with preoperative severe LUTS (AUAss ≥ 20; n = 53; 8%) were observed longitudinally for a mean of 4.0 years (range, 1.6-9.4 years) and were compared with men with mild-to-moderate LUTS (AUAss ≤ 19; n = 612; 92%). In men with severe LUTS, baseline average AUAss and QOL scores were 24.8 and 4.0, respectively. Long-term AUAss improved by 70% (17 points; P < .001); specifically 59% of patients had AUAss drop to <8, 35% of patients to 8-19, and 6% of patients remained at ≥ 20. The mean QOL scores declined from 4.0 to 2.0 (P < .05). Preoperatively, 38 of 52 patients (73%) had a poor QOL score of 4-6 compared with only 18% (P < .001) at long-term follow-up after RARP. Overall pad-free status was 71% vs 89%. In men with severe LUTS, RARP significantly improved urinary symptoms and QOL scores with an overall pad-free status of 71%. Specifically, these men should be counseled that RARP confers a significant short- and long-term benefit with regard to relief of their obstructive and irritative symptoms.

Risk and outcomes of chemotherapy-induced diarrhea (CID) among patients with colorectal cancer receiving multi-cycle chemotherapy.

Diarrhea is a common toxicity of chemotherapy, but the practice of reporting only severe grades (≥ 3) in clinical trials results in misleading conclusions of significance. Epidemiology remains poorly described, and effects of multi-cycle regimens have not been investigated. To better understand the risks, symptom burden and consequences of CID, we studied patients receiving chemotherapy for colorectal cancer (CRC). One hundred and fourteen patients receiving FOLFOX (95 patients, 530 cycles), FOLFOX + monoclonal antibodies (10 patients, 49 cycles) or FOLFIRI (9 patients, 50 cycles) were enrolled. CID was identified from diaries at baseline and daily during up to 8 chemotherapy cycles using supplemental questions on the Oral Mucositis Daily Questionnaire, a valid tool for collecting patient-reported outcomes of regimen-related mucosal injury. Patients scored CID severity from 0 "none" to 10 "worst possible," and quantity from "little" to "severe" on a 5-point scale. Quality of life was measured using the FACT-G, and fatigue using the FACIT fatigue scale. CID occurred in 89% of patients on FOLFIRI, 50% on FOLFOX + monoclonal antibodies and 56% on FOLFOX alone. The risk of a first episode was highest during Cycle 1 (35 %) and dropped to <10% during Cycles 3-5. Patients with CID reported poorer quality of life scores than those without CID (77.1 vs 80.7). Diarrhea occurs more commonly than typically appreciated during chemotherapy for CRC. Risk is highest during first exposure, suggesting variable susceptibility. Identification of this high-risk subgroup for prophylaxis could improve the quality of life.

G65 Long-term Gastro-intestinal morbidities in children with abdominal wall defects

IntroductionOutcome studies following repair of Congenital Abdominal Wall defect has mainly focused on the first two years of life. It is recognised that children with complicated Gastroschisis, short gut and...

Vision-Related Impact on Quality of Life in an Elderly Patient Population After Corneal Transplantation

The aim of this study was to assess the vision-related quality of life (QOL) and satisfaction of elderly patients who underwent corneal transplantations. Survey data using a modified version of the Visual Function Index were collected in February-March 2013 from 175 patients (age ≥65 years) of 414 eligible patients who underwent corneal transplantation between 2008 and 2010 at the Wilmer Eye Institute. The survey assessed visual functionality, independence, and satisfaction. Transplant surgeries were limited to penetrating keratoplasty, Descemet stripping automated endothelial keratoplasty (DSAEK), and keratoprosthesis. Sociodemographic and clinical data, including age, sex, initial and follow-up visual acuities, were collected. QOL survey measures were compared with patients' clinical findings to assess the differences between objective and subjective visual functioning. One hundred seventy-two patients were reviewed for surgery type. Eighty-six of 172 (50%) patients had follow-up data. Controlling for age, procedure, and baseline logarithm of the minimum angle of resolution (logMAR) visual acuity, patients treated by penetrating keratoplasty (P = 0.002) or keratoprosthesis (P = 0.019) were found to have poorer QOL scores than those treated with DSAEK. Age was positively associated with QOL improvement (P = 0.005). A relatively lower baseline vision (higher logMAR) was associated with a worse QOL (P < 0.001). When asked directly about their QOL, patients with relatively higher baseline vision (lower logMAR) reported no change in their QOL (P = 0.046). Type of surgery (DSAEK), older recipient age, and better baseline vision seem to be associated with an improved QOL in this study. Vision at follow-up is not associated with a QOL decline. Based on these findings, it is suggested that transplant surgery should be considered for elderly patients.

Nonmotor symptoms in a malaysian Parkinson's disease population.

Background. The nonmotor symptoms are important determinants of health and quality of life in Parkinson's disease but are not well recognized and addressed in clinical practice. This study was conducted to determine the prevalence of nonmotor symptoms and their impact on quality of life in patients with Parkinson's disease. Methods. This was a cross-sectional study among patients with idiopathic Parkinson's disease. Exclusion criteria were a Mini Mental State Examination score of <21/30. Prevalence of nonmotor symptoms was determined using the NMSQuest. The severity of nonmotor symptoms and the quality of life were assessed using validated disease-specific questionnaires (PDQ-39 and NMSS). Results. A total of 113 patients consisting of 60 males and 53 females were recruited. The median duration of illness was 5.0 (2.0–8.0) years. The prevalence rate of nonmotor symptoms in our cohort was 97.3%. The most common reported nonmotor symptom in our cohort was gastrointestinal (76.1%). We found that the severity of the nonmotor symptoms was associated with poorer quality of life scores (r s: 0.727, P < 0.001). Conclusions. Nonmotor symptoms were highly prevalent in our patients with Parkinson's disease and adversely affected the quality of life of our patients. In contrast to western studies, the most common nonmotor symptom is gastrointestinal. The possibility of an Asian diet playing a role in this observation requires further study.

Quality of Life before Hyperhidrosis Treatment as a Predictive Factor for Oxybutynin Treatment Outcomes in Palmar and Axillary Hyperhidrosis

Studies have suggested that quality of life (QOL) evaluation before video-assisted thoracoscopic sympathectomy for patients with hyperhidrosis may serve as a predictive factor for positive postoperative outcomes. Our study aims to analyze if this tendency is also observed in patients treated with oxybutynin for palmar and axillary hyperhidrosis. Five hundred sixty-five patients who submitted to a protocol treatment with oxybutynin were retrospectively analyzed between January 2007 and January 2012 and were divided into 2 groups according to QOL assessment before treatment. The groups consisted of 176 patients with "poor" and 389 patients with "very poor" QOL evaluation before oxybutynin treatment. Outcomes involving improvements in QOL and clinical progression of hyperhidrosis were evaluated using a validated clinical questionnaire that was specifically designed to assess satisfaction in patients with excessive sweating. Improvements in hyperhidrosis after oxybutynin were observed in 65.5% of patients with very poor pretreatment QOL scores and in 75% of patients with poor pretreatment QOL scores, and the only adverse event associated with oxybutynin treatment was dry mouth, which was observed with greater intensity in patients with very poor initial QOL evaluation. Improvements in hyperhidrosis after oxybutynin treatment were similar in both groups, suggesting that QOL before treatment is not a predictive factor for clinical outcomes, contrasting with surgical results that disclose significantly better results in patients with initially poorer QOL analysis.

Determinants of quality of life among people with epilepsy attending a secondary care rural hospita in south India

Context:Epilepsy is associated with profound physical, psychological, and social consequences.Aims:To assess the quality of life (QOL) among people with epilepsy attending the outpatient department of a secondary care hospital and to determine the various social and demographic factors affecting it.Materials and Methods:The QOL of 100 people with epilepsy attending the outpatient department of a community-based secondary care hospital was assessed using the WHOQOL-BREF (WHOQOL: World Health Organization QOL) questionnaire. Univariate analysis and logistic regression was done to determine the factors associated with poor QOL.Results:The QOL scores for all the domains ranged between 15.7 and 74.55 with a mean score of 51.49 [standard deviation (SD) 12.3]. The mean scores in the physical, psychological, social, and environmental domains were 55.7, 37.92, 57.75, and 50.56, respectively. Age more than 30 years [odds ratio (OR): 4.33, 95% confidence interval (CI): 1.73-10.82], female gender (OR: 2.90, 95% CI: 1.16-7.28), and currently married (OR: 3.82, 95% CI: 1.21-12.11) were the factors significantly associated with lower QOL scores.Conclusions:The QOL among people with epilepsy was lower in the psychological domain. Age more than 30 years, female gender, and being married were identified as the factors associated with poor QOL scores among people with seizure disorders.

Assessing depression and anxiety in the caregivers of pediatric patients with chronic skin disorders

BACKGROUND The literature has shown that the presence of emotional disturbances in caregivers of children with skin diseases affects the course and treatment of the disease. Anxiety and depression are among the most frequently reported psychiatric diagnoses related to this fact. OBJECTIVE To evaluate the presence of anxiety and depression in caregivers of pediatric patients with chronic skin disorders, exemplified by atopic dermatitis, psoriasis and vitiligo, and correlate them to the quality of life of the patients. METHODS The sample consisted of 118 patients with atopic dermatitis, vitiligo and psoriasis, monitored by their main caregiver. The levels of anxiety and depression in the caregivers were assessed using the Hamilton Anxiety Scale and the Beck Depression Inventory, respectively. The Children's Dermatology Life Quality Index was applied. RESULTS Anxiety was observed in 36% of the caregivers of the patients with atopic dermatitis, in 36% of those of children affected by psoriasis, and in 42% of those responsible for pediatric patients with vitiligo. Depression occurred in 36% of the caregivers of patients with atopic dermatitis, in 36% of those of children affected by psoriasis and in 26% of those responsible for pediatric patients with vitiligo. There was a significant correlation between poor quality of life scores in patients with vitiligo and the presence of depression and anxiety in their caregivers. CONCLUSION Emotional disorders tend to be present among close family members of children with the chronic skin diseases studied and their prevention can help in controlling and treating these diseases.

The Burden Of Illness and Prevalence In Diffuse Large B-Cell (DLBCL) and Follicular (FL) Lymphomas

IntroductionIn non-Hodgkin lymphoma (NHL), particularly diffuse large B-cell (DLBCL) and follicular (FL) lymphomas, the prevalence, burden of disease, including that of relapse/recurrence, and quality of life (QoL) play a role in how novel treatment strategies are evaluated. We conducted a literature review to identify whether the current understanding of the prevalence, burden of illness (BOI) including QoL in these two predominant NHL histologies is sufficient to support novel treatment and resource allocation decisions. MethodsUsing EMBASE, PubMed, Cochrane, conference abstracts, treatment guidelines, and government, business and industry literature such as data from the WHO, we identified estimates for prevalence and BOI, defined as disease-related costs and QoL, for DLBCL and FL, from 2005 to 2013 in the US and EU5 (France, Germany, Italy, Spain, UK). In addition to appropriate MeSH (Medical Subject Headings) terms, search terms included, but were not limited to, burden of illness, quality of life, QoL, HRQoL, cost, direct cost, resource use, resource utilization, economic, incidence, prevalence, epidemiology, and mortality. FindingsBOI-related information within DLBCL and FL are very limited and antiquated DLBCLOnly one health economic study was identified – a US study using data from 1999-2000 in patients with aggressive NHL, including DLBCL (Kutikova et al. Leuk Lymphoma. 2006). Among the patients receiving initial treatment, which did not include the current standard of care R-CHOP, 68% of patients experienced treatment failure. The incremental cost of treatment failure was $14,174 per month, driven by higher initial treatment costs ($13,866 vs $4,754) and the need for secondary and/or palliative care ($5,062). However, these data may not accurately depict relapse rates and costs associated with more current standards of care. For QoL, one study was identified in DLBCL, a US based study in the elderly. The NCI sponsored Surveillance, Epidemiology, and End Results-Medical Health Outcomes Survey database was used to evaluate QoL in elderly DLBCL patients using the Short Form (SF-36) Health Survey. Patients surveyed 0–1 year after the diagnosis of DLBCL had poor QoL scores (physical component [PCS] median=33.6, mental component [MCS] median=40.8, poor self-rated health: 51.6%) (Kelly et al. Blood. 2012). FLOnly one health economic study was identified – a US study using data from 2006-2009 which estimated the cost of disease progression. Results showed that mean overall per patient per month (PPPM) costs over the 6-month follow-up were significantly higher for patients with progressive disease (PD) vs non-PD ($3527 vs. $860; difference=$ 2667; p<0.001) (Beveridge et al. Leuk Lymphoma. 2011). One QoL study was identified, a UK study that reported statistically significant differences by disease state using multiple QoL instruments. The total scores derived from the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym) questionnaire showed that relapsed patients have lower QoL scores (109.7) than newly diagnosed patients (136.4), those achieving partial (128.81) or complete response (133.28), or when disease free (135.26) (p = 0.001) (Pettengell et al. Ann of Oncol. 2008).Regarding prevalence data, in the EU5, prevalence of DLBCL ranges from 30 – 58% of NHL cases and in the US estimates range from 25 – 35%. Prevalence of FL is lower, ranging from 11 – 19% in the EU5 and 20 – 25% in the US. Regarding the prevalence of relapse/recurrent disease, one-third of DLBCL patients are either relapsed or refractory after standard therapy (Friedberg. Clin Cancer Res. 2011; Abramson et al. Blood. 2005). ConclusionsCurrently available data related to BOI and prevalence are limited and dated making it difficult to accurately assess the impact of DLBCL and FL on patients and healthcare systems. In the absence of renewed information it may be challenging to quantify the incremental impact that novel regimens may have on clinical outcomes, BOI, and QoL. While NHL mortality has steadily decreased over the past few decades as treatment options have improved, updated and accurate epidemiologic and BOI data are needed to better characterize the impact that novel treatments in development may have on the overall clinical, BOI and patient-reported outcomes in DBLCL and FL. Disclosures:Dulac: Celgene Corporation: Employment. Joy: IMS Health: Employment. Ndindjock: IMS Health: Employment. Coyle: IMS Health: Employment. Wade: IMS Health: Employment, Research Funding.

Quality of life and survival in patients with heart failure

To examine whether self-rated disease-specific and generic quality of life predicts long-term mortality, independent of brain natriuretic peptide (BNP) levels, and to explore factors related to low quality of life in a well-defined heart failure (HF) population. A cohort of 661 patients (62% male; age 71 years; left ventricular ejection fraction 34%) was followed prospectively for 3 years. Quality of life questionnaires (Ladder of Life, RAND36, and Minnesota Living with Heart Failure Questionnaire) and BNP levels were assessed at discharge after a hospital admission for HF. Three-year mortality was 42%. After adjustment for demographic variables, clinical variables, and BNP levels, poor quality of life scores predicted higher mortality; per 10 units on the physical functioning [hazard ratio (HR) 1.08, 95% confidence interval (CI) 1.02-1.14] and general health (HR 1.08, 95% CI 1.01-1.16) dimensions of the RAND36. Patients with low scores on these dimensions were more likely to be in New York Heart Association class III-IV, diagnosed with co-morbidities, have suffered longer from HF, have lower estimated glomerular filtration rates, and have fewer beta-blocker prescriptions. Quality of life was independently related to survival in a cohort of hospitalized patients with HF. NCT 98675639.

Efficacy and Safety of Eltrombopag for the Treatment of Thrombocytopenia of Low and Intermediate-1 IPSS Risk Myelodysplastic Syndromes: Interim Analysis of a Prospective, Randomized, Single-Blind, Placebo-Controlled Trial (EQoL-MDS)

AbstractAbstract 923 Introduction:The increased risk of bleeding in myelodysplastic syndromes (MDS) is due to low platelet (PLT) counts and abnormalities of PLT morphology and function. Severe thrombocytopenia occurs in about 10% of low and Int-1 International Prognostic Scoring System (IPSS) risk MDS patients in whom PLT transfusions are indicated mainly in the presence of bleeding. Short therapeutic effect and the development of refractoriness to PLT transfusions motivate research in novel treatments. Eltrombopag is an oral, non peptide, non-competitive agonist of the thrombopoetin-receptor (TPOR) which interacts selectively with the TPOR transmembrane domain to initiate TPO signaling. Eltrombopag is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura. Its potential in increasing PLT count in lower risk MDS has not been evaluated. Study Design and Methods:We present preliminary results of a Phase II, multicentre, prospective, placebo-controlled, single blind study to evaluate the safety and efficacy of eltrombopag in low and intermediate-1 risk adult MDS patients with PLT count <30 Gi/L. Patients are included if: ECOG performance status < 4; ineligible for or relapsed or refractory to other treatments; and naive to TPO-R agonists. Secondary endpoints include differences in: changes in quality of life (QoL) scores by EORTC QLQ-C30 and QOL-E v. 3 questionnaires, frequency of PLT transfusions, incidence and severity of bleeding, and overall and leukemia-free survival. Eltrombopag or placebo (2:1 ratio) is administered to 69 patients at a 50 mg daily initial dose with 50 mg increases every 2 weeks to a target PLT count of 100 Gi/L. Dose interruptions or reductions are required for PLT >200 Gi/L or adverse events. PLT response is defined as Response (R) if: 1) baseline > 20 Gi/L: absence of bleeding and absolute increase in PLT ≥ 30 Gi/L/mm3; 2) baseline < 20 Gi/L: PLT <20 Gi/L and increase by at least 100%, not due to PLT transfusion; and Complete Response (CR) if PLT count ≥ 100 Gi/L and absence of bleeding. Bone marrow (BM) aspirate smears, cytogenetics and peripheral blood (PB) smears are performed throughout the study and blinded centralized morphology review is performed. Results:Seventeen patients (10 on active drug – Arm A) of mean age 64, SD 12, years are randomized and 2 are in screening at the time of the present report. Baseline mean PLT count was 14, SD 8, Gi/L. Three cases had significant bleeding (2 in Arm A, and 1 in Arm B) and 2 patients in each arm required PLT transfusions during screening. After a mean follow up of 6 months, 5 cases on the eltrombopag arm have obtained a CR (1 at day 8, 3 at day 15 with 50 mg dosing, and 1 at day 54 with 100 mg dosing) and one case is in R at 8 weeks follow-up; amongst non-responders, two have reached a 300 mg dose, the remaining are ongoing at a 100 and 150 mg dose, respectively. In Arm B, there was one case with an unstable R. In Arm A, PLT count increased by mean 68 SD 76 Gi/L (p=0.010) after 4 weeks and 114 SD 110 Gi/L (p=0.021) after 8 weeks, versus no significant change in Arm B. Furthermore, after 2 months, no bleeding occurred in Arm A (N=9) versus 3 cases with bleeding in Arm B (N=6). In fact, no PLT transfusions were required in Arm A, while 3 patients were transfused at 2 months in Arm B. At baseline, patients presented poor QoL scores. Overall, of the 9 patients in arm A reaching a 3-month follow-up, there were significant improvements in functional QoL, from baseline median score 33 (IQR 22–67) to 78 (IQR 31–92, p=0.047) and treatment-related scores from median 51 (IQR 35–66) to 74 (IQR 35–82, p=0.029). Grade III-IV adverse events (worsening of pre-existing arthritis; acute febrile enteritis) occurred in only 2 patients in Arm A, all unrelated to eltrombopag. Progressions have not been observed in Arm A, versus 1 progression in Arm B. No deaths have occurred at the time of the present analysis. Conclusions:Preliminary results suggest safety of eltrombopag in terms of drug-related adverse events and disease progression in MDS patients with low and Intermediate-1 risk IPSS and thrombocytopenia. In such patients, eltrombopag treatment is effective in raising PLT counts and in reducing the risk of bleeding and is associated with significant improvements in QoL. Disclosures:Off Label Use: Eltrombopag is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) .

Quality of Life, Depression, and Anxiety 6 Months After Inpatient Withdrawal in Patients With Medication Overuse Headache

Patients with medication overuse headache (MOH) experience decreased quality of life (QoL) and increased psychiatric comorbidity. We performed an observational study in patients with MOH to assess whether QoL (primary outcome parameter), depression, and anxiety (secondary outcome parameters) improve after inpatient withdrawal therapy. Forty-two patients undergoing the usual regimen established for inpatient withdrawal therapy at our department completed a structured questionnaires (the Short Form-36 health survey, Self-Rating Depression Scale, and Self-Rating Anxiety Scale) immediately before inpatient withdrawal. Six months after withdrawal, they were examined again with the same questionnaires. Thirty-two patients (27 female) aged 46.8±9.4 years could be interviewed twice. At baseline, QoL was decreased compared with normative data (z-scores ranging from -1.2 to -2.0). Depression was present in 65.6% and anxiety disorder in 71.9% of the patients. At follow-up, physical QoL (P<0.001) and mental QoL (P=0.019) had improved, but QoL was still impaired (z-scores ranging from -0.3 to -1.3). Depression and anxiety scores had decreased significantly. Poor mental QoL and high scores of depression and anxiety at baseline correlated with frequent headaches at follow-up (P=0.013, P=0.024, and P=0.008, respectively). QoL is impaired in patients with MOH, and many patients are depressed and anxious. Inpatient withdrawal therapy lead to a statistically significant improvement of QoL, depression, and anxiety. Poor baseline mental QoL as well as depression and anxiety are associated with poor outcome in terms of headache frequency.

Baseline Quality of Life Assessed with the EORTC QLQ-C30 Predicts the Treatment Outcome of Patients with Diffuse Large B-Cell Lymphoma: Results of a Prospective Cohort Study

Abstract 1595 Background:The self-reported Quality of life (QoL) assessment has been widely used as an endpoint for clinical trials along with traditional endpoints of response and survival because the QoL can provide the health-related information, and it should be considered another parameter to estimate the efficacy of treatment. However, there is growing evidence that the QoL assessment can be used as a prognostic factor in cancer patients. Thus, the prognostic value of baseline QoL was reported in several different types of cancers independent of other clinical prognostic factors. Considering the performance status of patients is an important prognostic factor in lymphoma, the assessment of QoL at diagnosis might be an informative tool for predicting treatment outcome of lymphoma. However, few data exists regarding the prognostic relevance of baseline QoL in patients with lymphoma. Thus, we evaluated the prognostic impact of baseline QoL on the outcome of patients with diffuse large B-cell lymphoma (DLBCL), the most common subtype of non-Hodgkin lymphoma. Methods:The Samsung Medical Center Lymphoma Cohort Study (SMCLCS) is a prospective cohort study registering patients diagnosed with Hodgkin and non-Hodgkin lymphoma at the Samsung Medical Center (NCT00822731). All patients completed the version 3.0 of the European Organization for Research and Treatment of Cancer (EORTC) Core Questionnaire (QLQ-C30) after they provided written inform consents. Among patients registered in the SMCLCS, we analyzed the baseline QoL and clinical data of 263 patients consecutively diagnosed with DLBCL between September 2008 and February 2011. Primary CNS lymphoma was excluded, thus, all patients were treated with rituximab-CHOP. We made a prognostic model according to the scores of three items: (1) Global health status representing general health condition, (2) Functional scale representing physical function, (3) Symptom scales representing symptoms and signs. Each item was counted as one point if the score of each item was higher than 50. Thus, patients were classified as good (3 points), moderate (2 points) and poor QoL (score =0 or 1) groups. The QoL scores of patients with marginal zone B-cell lymphoma (MZL, n = 110) were used as a control. Results:The median score of Global health status was 50 (range 0–100) while the median scores of Functional and Symptom scales were 78.4 (24.1–100.0) and 79 (25.9–100.0), respectively in patients with DLBCL. These scores were significantly lower than a control group, MZL (P < 0.05). When patients were categorized into three groups, the good and moderate QoL groups accounted for 43.0% (n = 113) and 41.1% (n = 108) of patients, respectively. The proportion of poor QoL group of DLBCL was 16.0% (n = 42), and it was higher than that of MZL (2.7%). When the QoL at diagnosis was compared with other clinical factors, the poor QoL was significantly associated with poor ECOG performance status (≤ grade 2) whereas age older than 60 years was not significantly related with the poor QoL. The clinical factors representing high tumor burden such as elevated serum LDH, the number of extranodal involvement and Ann Arbor stage were significantly associated with the QoL model, thus, patients with high tumor burden showed poor QoL (P < 0.05). In consistent with this, patients with high or high-intermediate International Prognostic Index showed worse QoL scores than low or low-intermediate risk group. The frequency of treatment-related mortality was significantly higher in patients belonging to moderate and poor QoL groups than good QoL group (P < 0.05). As a result, more than 20% of the moderate or poor QoL group failed to complete the planned treatment schedule of rituximab-CHOP while only 10% of patients of the good QoL group could not finish the treatment. As a result, the overall survival of the good QoL group was significantly better than moderate and poor QoL groups (p < 0.05). This risk stratification based on the baseline QoL assessment was independently prognostic for overall survival in the multivariate analysis after controlling for International Prognostic Index. Conclusion:The baseline quality of life assessed with the EORTC QLQ-C30 is significantly associated with high tumor burden and worse overall survival of DLBCL. Thus, this prospective result suggests that the it may become a feasible prognostic factor in patients with DLBCL. Disclosures:No relevant conflicts of interest to declare.