Health-related Quality Of Life Profile Research Articles

Health Related Quality of Life of Long-Term Survivors of Acute Promyelocytic Leukemia Treated with All-Trans Retinoic Acid and Chemotherapy

Background:Combined treatment with all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy regimens has remarkably contributed to improve treatment outcomes in patients with Acute Promyelocytic Leukemia (APL) patients leading to cure rates above 80%. However, information is lacking on how these patients might recover in the long-term period.Objective:The primary objective of this study was to investigate long-term health-related quality of life (HRQOL) and symptom burden in APL and to examine factors predicting better long-term HRQOL outcomes.Patients and Methods:Patients with APL treated within two large GIMEMA trials (i.e., AIDA0493 and AIDA 2000) were considered. All patients received ATRA plus Idarubicin (AIDA) for induction followed by consolidation that was risk-adapted in AIDA2000 and in most cases, maintenance for 2 years . The main inclusion criterion was having survived the initial diagnosis for more than 5 years and being in complete remission (CR) at the time of study inclusion. The SF-36 was used to assess generic HRQOL. This questionnaire consists of 36 items covering eight generic health status/QoL domains: physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and mental health (MH). Mean SF-36 scores were compared between APL patients and those from general population. To minimize bias, all comparisons were performed between APL patients and corresponding propensity score-matched peers from general population, further adjusting for education, family status and geographical area using a multivariate linear mixed model. For descriptive purposes, a cut-off of 30 years was considered to distinguish between younger and older patients at the time of diagnosis and the corresponding HRQoL profiles were compared using multivariate linear regression analysis to adjust for key potential confounders. Also, M.D. Anderson Symptom Inventory (MDASI) was assessed to investigate the profile and prevalence symptom burdenResults:Of the 307 patients, potentially eligible for this analysis and invited to participate in the study, 244 completed a HRQOL questionnaire (compliance 79.5%). No differences were found in the main socio-demographic and clinical characteristics between patients with or without a HRQOL evaluation. Mean age of patients was 52 years (range 20-90) and there were 47% males and 53% females. Median time from diagnosis was 14 years (range: 4-20). There were 81% of patients reporting at least 1 comorbidity at the time of HRQOL evaluation. APL long-term survivors reported a HRQOL profile broadly similar to that of their peers in the general population. However, the RP scale was statistically (P=0.016) and clinically meaningful worse in APL patients. Fatigue was the most prevalent symptom with 70% of patients reporting it with any level of concern, as well the most frequently reported moderate to severe symptom by 29 % of patients. Being distressed and problem with remembering things were the other two most prevalent symptoms reported by 65% and 62% of patients respectively. Being diagnosed at a younger age (<30 years) was a key factor associated with better long-term HRQOL outcomes. This was particularly relevant in physical health aspects. Detailed results of adjusted mean differences in SF-36 scores between age groups are reported in Table 1.ConclusionsAPL patients successfully treated with AIDA-like regimens may expect to have broadly similar HRQOL outcomes when compared to their peers witout cancer in the general population. However, significant limitations in work or other daily activities due to physical and emotional problems still persist after many years from diagnosis in the majority of patients. Our results also show that on the long-term period, younger APL patients recover better than older ones in terms of HRQOL outcomes. [Display omitted] DisclosuresEfficace:TEVA: Consultancy, Research Funding; Seattle Genetics: Consultancy; Bristol Myers Squibb: Consultancy; Lundbeck: Research Funding. Breccia:Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Ariad: Honoraria; Pfizer: Honoraria. Angelucci:Novartis oncology, celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Lo Coco:Teva: Consultancy, Honoraria, Speakers Bureau; Lundbeck: Honoraria, Speakers Bureau; Novartis: Consultancy; Baxalta: Consultancy; Pfizer: Consultancy.

Burden of AL Amyloidosis on Health-Related Quality of Life in Clinic-Based, Community-Based, and Trial-Based Studies

Introduction: Light chain (AL) amyloidosis is a rare disease characterized by misfolded amyloid protein deposits in tissues and vital organs which may lead to organ failure, disability, and death. Little is known about the burden of AL amyloidosis on health-related quality of life (HRQoL) - particularly whether patients in different types of studies experience the same degree and type of burden or whether there are unique differences.The objective of this study is to compare the HRQoL profile of patients with AL amyloidosis from clinic-, community-, and clinical trial-based samples to a general population (GP) sample and other benchmarks from more commonly known diseases.MethodsSampleData were drawn from three different samples of AL amyloidosis patients:1. A clinic-based sample of AL amyloidosis patients seen at the Amyloidosis Center at Boston University between 1994 and 2014 who completed the HRQoL survey within 30 days of their initial evaluation (n=1,438)2. A community-based sample of patients who completed a cross-sectional online survey in the Fall of 2015 (n=341)3. A trial-based sample of treatment naïve patients with cardiac involvement who completed the HRQoL survey during baseline data collection of the VITAL Amyloidosis Study, a Phase 3 randomized control trial (RCT) of NEOD001 (clinical trials.gov ID: NCT02312206; n=85)MeasuresAll three studies assessed HRQoL using the SF-36® Health Survey (SF-36). The SF-36v1 was administered to the clinic-based sample and the SF-36v2 was administered to the community- and trial-based samples. The SF-36 measures eight domain scales (physical functioning (PF), role limitations due to physical health problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional health problems (RE), and mental health (MH)) and two component summary measures: physical (PCS) and mental (MCS).AnalysisAnalysis of variance was used to compare the norm-based SF-36 scores from patients with AL amyloidosis to that from samples representing a GP norm. The GP data were adjusted to the age and gender distribution of the patient samples using separate ordinary least-squares regression models, with each SF-36 scale or summary score as a dependent variable. Using the same method, mean SF-36 scales and summary scores in the three AL amyloidosis patient samples were compared to the mean SF-36 scores in other disease populations, including congestive heart failure (CHF) and kidney disease (KD). Established minimally important differences (MIDs) were used to determine whether deficits in HRQoL were clinically meaningful, as well as statistically significant.Results: Differences between AL amyloidosis patients’ SF-36 scores and those of the GP are presented in Table 1 by sample. Relative to the GP, patients with AL amyloidosis exhibited broad deficits in HRQoL, particularly related to physical well-being. Deficits were more prominent for PCS where the differences between the GP scores and the scores observed in all three AL amyloidosis samples were both statistically significant and clinically meaningful (p < 0.001 and D ≥ 2.0 points for all).Differing patterns of relative burden emerged when AL amyloidosis samples were compared to other common disease benchmarks:· As compared to the CHF benchmarks, scores for PCS among the community-based sample were statistically and clinically better (p < 0.001 and D=4.5); whereas, PCS scores were significantly worse among the trial-based sample (p < 0.01 and D=-8.9).· Relative to KD benchmarks, the trial-based, treatment naïve sample reported significant deficits across many scores that were comparable in the community-based sample, including RP, VT, and PCS.Conclusions: Regardless of the data source, patients with AL amyloidosis exhibited significant and clinically meaningful deficits in HRQoL compared to the GP. Despite heterogeneity across the three samples in terms of duration and severity of disease, deficits related to physical well-being were consistent and clinically meaningful. Different patterns of deficits emerged when comparing the three samples to other disease benchmarks. This may be due to the heterogeneity in the community-based sample where patients varied in duration of disease and course of treatment versus the other AL amyloidosis samples which were comprised of newly diagnosed and/or treatment naïve patients. [Display omitted] DisclosuresBayliss:Prothena Biosciences Inc: Research Funding. White:Prothena Biosciences Inc: Research Funding. McCausland:Prothena Biosciences Inc: Research Funding. Guthrie:Prothena: Employment, Equity Ownership, Other: Leadership.

Optimizing the Adverse Event and HRQOL Profiles in the Management of Primary Spine Tumors.

Systematic literature review. To investigate if evidence-based principles of oncologic resection for primary spinal tumors are correlated with an acceptable morbidity and mortality profile and satisfactory health-related quality of life (HRQOL) measures. Respecting oncologic principles for primary spinal tumor surgery is correlated with lower recurrence rates. These interventions are, however, often highly morbid. A systematic literature review was performed to address the objectives by searching MEDLINE and EBMR databases. Articles that met our inclusion criteria were reviewed. GRADE guidelines were used for recommendation formulation. A total of 25 articles addressing the morbidity and mortality profile of primary spinal tumor surgery were identified. For sacral tumors, complication rates of up to 100% have been reported and complication-related death ranged from 0% to 27%. Mobile spine tumor complication rates varied from 13% to 73.7% and complication-related death ranged from 0% to 7.7%. Seven articles examining HRQOL for this patient population were identified. The limited literature showed comparable patient HRQOL profiles to those with benign conditions such as degenerative disc disease. Respecting oncologic principles for primary spinal tumors are correlated with high adverse event rates. We recommend that primary spinal tumor surgeries be performed in experienced centers with multidisciplinary support teams and that prospective adverse event collection be promoted (strong recommendation/very low certainty of the evidence). Oncologic resection of primary tumors of the spine is associated with HRQOL that more closely approximates normative values with increasing duration of follow-up, but decreases with disease recurrence. We recommend primary spinal tumor surgery be performed with a curative intent whenever possible, even at the expense of greater initial morbidity to optimize long-term HRQOL (strong recommendation/very low certainty of the evidence). N/A.

Herbal Medicine Cordyceps sinensis Improves Health-Related Quality of Life in Moderate-to-Severe Asthma.

Moderate-to-severe asthma has a substantial impact on the health-related quality of life (HR-QOL) of the patients. Cordyceps sinensis is a traditional Chinese medicine that is evaluated clinically for the treatment of many diseases, such as chronic allograft nephropathy, diabetic kidney disease, and lung fibrosis. In order to investigate the effects of Cordyceps sinensis on patients with moderate-to-severe persistent asthma, 120 subjects were randomized to receive Corbin capsule containing Cordyceps sinensis for 3 months (treatment group, n = 60), whereas the control group (n = 60) did not receive treatment with Corbin capsule. Inhaled corticosteroid and as-needed β-agonists were used in the treatment of both groups. HR-QOL was measured with the Juniper's Asthma Quality of Life Questionnaire (AQLQ). The incidence of asthma exacerbation, pulmonary function testing, and serum measurements of inflammatory mediators were also evaluated. The results showed that the treatment group indicated a significant increase in AQLQ scores and lung function compared with the control group. The expression levels of the inflammation markers IgE, ICAM-1, IL-4, and MMP-9 in the serum were decreased and IgG increased in the treatment group compared with the control group. Therefore, the conclusion was reached that a formulation of Cordyceps sinensis improved the HR-QOL, asthma symptoms, lung function, and inflammatory profile of the patients with moderate-to-severe asthma. This trial is registered with ChiCTR-IPC-16008730.

Age and Gender-Related Pretreatment Quality of Life Profiles in Patients with Higher-Risk Myelodysplastic Syndromes. Establishing Benchmark Data from an International Study

Background:Patients myelodysplastic syndromes (MDS) diagnosed with higher-risk disease have poor prognosis thus making improvements in health-related quality of life (HRQOL) a major goal of therapy. Understanding HRQOL profile of untreated patients is important to help clinicians to better target subpopulations in need of special attention from the very beginning of therapy.Aims:The primary objective of this study is to investigate whether HRQOL differences exist by age and gender in untreated patients with higher-risk MDS. A secondary objective is to provide age and gender pretreatment HRQOL profiles to be used as reference baseline data for comparing HRQOL of MDS patients under treatments.Methods:This analysis is based on 280 adult patients diagnosed with IPSS risk score of intermediate-2 (74%) and high-risk (26%), enrolled in an international prospective observational study. Median age of patients was 71 years (range 32-89), 176 were men (63%) and 104 (37%) women. HRQOL was assessed at study entry and before treatment for higher-risk disease (except for transfusions), with the EORTC QLQ-C30, the most widely used HRQOL outcome measure in MDS research. Thus, our data are likely to further ease interpretation of outcomes in many studies using this questionnaire. One hundred seventy-five patients had received at least one red blood cell transfusion at the time of baseline HRQOL assessment. HRQoL data of MDS patients were age-gender matched with those general population norms. Wilcoxon-Mann-Whitney and Wilcoxon signed ranks tests were used for unmatched and matched comparisons, respectively (α=0.05). Effect sizes were also computed.Results:No statistically significant differences existed in any of the HRQOL domain by IPSS category (intermediate-2 versus high-risk). However, HRQOL profiles differed by age and gender and results are reported in Table 1. Women generally reported lower HRQOL scores than men, with statistically significant impairments in the global quality of life (P=0.008), role (P=0.014), emotional (P=0.024) and social functioning (P=0.028). When compared to their peers in the general population, HRQOL was found to be impaired in all age group categories (Figure 1, A and B). However, the magnitude of impairments across HRQOL domains was markedly larger in younger patients (aged 30-59 years) compared to older age groups (≥60 years). The top three largest impairments in this younger group were found for: fatigue (ES=2.47, P<0.001), dyspnea (ES=2.14, P<0.001) and role functioning RP (ES=1.96, P<0.001). This latter aspect indicates the ability to perform daily activities.Conclusion:Pretreatment HROQL of higher-risk MDS patients vary by age and gender and current reference data will help making more accurate comparisons with HRQOL of patients under treatment. Clinicians should also pay special attention to younger patients, as these are those most in need of HRQOL improvements. [Display omitted] [Display omitted] [Display omitted] DisclosuresGaidano:MorphoSys; Roche; Novartis; GlaxoSmithKline; Amgen; Janssen; Karyopharm: Honoraria, Other: Advisory boards; Celgene: Research Funding. Santini:celgene, Janssen, Novartis, Onconova: Honoraria, Research Funding. Platzbecker:Celgene: Honoraria; GlaxoSmithKline: Honoraria, Research Funding; Novartis: Honoraria; Amgen, Inc.: Honoraria. Di Renzo:Celgene: Research Funding.

A cross-sectional assessment of health-related quality of life among type 2 diabetes patients in Riyadh, Saudi Arabia.

Objective:This study aimed to describe the health-related quality of life profile among type 2 diabetes patients in Riyadh, Saudi Arabia.Method:A cross-sectional study was undertaken using a cohort of 75 patients attending the University Diabetic Centre at King Abdulaziz University Hospital, Riyadh, Saudi Arabia. EuroQoL-5 dimension (EQ-5D) scale was used for the assessment of health-related quality of life. EQ-5D was scored using values derived from the UK general population survey. Inferential statistics were applied to evaluate associations between study variables. The Statistical Package for Social Sciences version 20.0 was used for data analysis; p <0.05 was set as the level of statistical significance.Results:Fifty-eight (77.35%) respondents were male with a mean 12.6 ± 8.4 years of history of diabetes. Thirty-four (45.3%) were categorised into the age group of 45–55 years with a mean age of 54 ± 9.2 years. Forty-four (58.7%) were using oral hypoglycaemic agents and 40 (53.3%) had a university level of education. A moderate level of health-related quality of life (0.70 ± 0.22) was measured in the study cohort. Gender was significantly associated with health-related quality of life scores (p = 0.001). The mean EQ-5D score was lower in females compared to male patients (0.58 ± 0.23 vs 0.74 ± 0.20). There were no statistically significant associations between health-related quality of life scores and age groups, duration of diabetes, marital status, educational level and type of treatment.Conclusion:This study has highlighted that Saudi diabetes patients have low levels of health-related quality of life. Healthcare professionals need to consider this when planning holistic patient treatment approaches.

Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer

To assess the efficacy of inhaled ginger aromatherapy on nausea, vomiting and health-related quality of life (HRQoL) in chemotherapy breast cancer patients. Single-blind, controlled, randomized cross-over study. Patients received 5-day aromatherapy treatment using either ginger essential oil or fragrance-matched artificial placebo (ginger fragrance oil) which was instilled in a necklace in an order dictated by the treatment group sequence. Two oncology clinics in the East Coast of Peninsular Malaysia. VAS nausea score, frequency of vomiting and HRQoL profile (EORTC QLQ-C30 scores). Sixty female patients completed the study (age=47.3±9.26 years; Malay=98.3%; on highly emetogenic chemotherapy=86.7%). The VAS nausea score was significantly lower after ginger essential oil inhalation compared to placebo during acute phase (P=0.040) but not sustained for overall treatment effect (treatment effect: F=1.82, P=0.183; time effect: F=43.98, P<0.001; treatment×time effect: F=2.04; P=0.102). Similarly, there was no significant effect of aromatherapy on vomiting [F(1, 58)=0.29, P=0.594]. However, a statistically significant change from baseline for global health status (P<0.001) was detected after ginger essential oil inhalation. A clinically relevant 10 points improvement on role functioning (P=0.002) and appetite loss (P<0.001) were also documented while patients were on ginger essential oil. At present time, the evidence derived from this study is not sufficiently convincing that inhaled ginger aromatherapy is an effective complementary therapy for CINV. The findings for HRQoL were however encouraging with significant improvement in several domains.

Putting the Patient in Patient Reported Outcomes: A Robust Methodology for Health Outcomes Assessment.

When analyzing many health-related quality-of-life (HRQoL) outcomes, statistical inference is often based on the summary score formed by combining the individual domains of the HRQoL profile into a single measure. Through a series of Monte Carlo simulations, this paper illustrates that reliance solely on the summary score may lead to biased estimates of incremental effects, and I propose a novel two-stage approach that allows for unbiased estimation of incremental effects. The proposed methodology essentially reverses the order of the analysis, from one of 'aggregate, then estimate' to one of 'estimate, then aggregate'. Compared to relying solely on the summary score, the approach also offers a more patient-centered interpretation of results by estimating regression coefficients and incremental effects in each of the HRQoL domains, while still providing estimated effects in terms of the overall summary score. I provide an application to the estimation of incremental effects of demographic and clinical variables on HRQoL following surgical treatment for adult scoliosis and spinal deformity.

Holistic life-span health outcomes among elite intercollegiate student-athletes.

Competitive sports are recognized as having unique health benefits and risks, and the effect of sports on life-span health among elite athletes has received increasing attention. However, supporting scientific data are sparse and do not represent modern athletes. To assess holistic life-span health and health-related quality-of-life (HRQL) among current and former National Collegiate Athletic Association student-athletes (SAs). Cross-sectional study. A large Division I university. Population-based sample of 496 university students and alumni (age 17-84 years), including SAs and an age-matched and sex-matched nonathlete (NA) control group. Participants completed anonymous, self-report questionnaires. We measured the Short-Form 12 (SF-12) physical and mental component HRQL scores and cumulative lifetime experience and relative risk of treatment for joint, cardiopulmonary, and psychosocial health concerns. Older alumni (age 43+ years) SAs reported greater joint health concerns than NAs (larger joint summary scores; P = .04; Cohen d = 0.69; probability of clinically important difference [pCID] = 77%; treatment odds ratio [OR] = 14.0, 95% confidence interval [CI] = 1.6, 126). Joint health for current and younger alumni SAs was similar to that for NAs. Older alumni reported greater cardiopulmonary health concerns than younger alumni (summary score P < .001; d = 1.05; pCID = 85%; OR = 5.8, 95% CI = 2.0, 16) and current students (P < .001; d = 2.25; pCID >99.5%; OR = 7.1, 95% CI = 3.3, 15), but the risk was similar for SAs and NAs. Current SAs demonstrated evidence of better psychosocial health (summary score P = .006; d = -0.52; pCID = 40%) and mental component HRQL (P = .008; d = 0.50; pCID = 48%) versus NAs but similar psychosocial treatment odds (OR = 0.87, 95% CI = 0.39, 1.9). Psychosocial health and mental component HRQL were similar between alumni SAs and NAs. No differences were observed between SAs and NAs in physical component HRQL. The SAs demonstrated significant, clinically meaningful evidence of greater joint health concerns later in life, comparable cardiopulmonary health, and differences in life-span psychosocial health and HRQL profiles compared with NAs. These data provide timely evidence regarding a compelling public issue and highlight the need for further study of life-span health among modern athletes.

Calidad de vida relacionada con la salud en adultos mayores de hogares geriátricos, Medellín, Colombia, 2012

Introduction: Elderly in Medellin present conditions of economic, social, environmental and gen-eral health vulnerability; in nursing homes shows further deterioration of health related quality of life (HRQOL). Objective: To compare the profile of HRQOL of adults over public and private nursing homes in Medellin. Materials and methods: Across-sectional correlational study in 220 elderly selected using probability sampling. WHOQOL-BREF was used and the clinical data of each individual. We assessed scale reliability using Cronbach’s alpha, internal consistency and discriminant validity using Pearson correlations, analyzes of HRQOL were based on summaries measures and frequencies, non-parametric and parametric tests and lineal regression. Results: We found 50 % hypertension, 23.6 % diabetes mellitus, dislipidemia 22.3 % and 15 % osteoporosis. The WHOQOL-BREF showed excellent reliability, internal consistency and discriminant validity, the best score was the psychological health and worst in social relationships. We found no differ¬ences in HRQOL by type of nursing home. The main factors related to HRQL were satisfaction with family support and participation in social groups. Conclusion: We identified some determinants of HRQOL, this demonstrated its multidimensionality; relevant information for further research and for the implementation of public health policies and clinical actions.

Assessment of health-related quality of life among hypertensive patients: a cross-sectional study from Palestine

Aim The ability to identify indicators of poor health-related quality of life (HRQoL) is crucial for both improving clinical care and determining targets of intervention for the prevention and treatment of disease. The main objectives of this study were to assess the HRQoL profile of the hypertensive population from Palestine, and to determine the socio-demographic and clinical characteristics associated with poor HRQoL.

Quality of life in patients at first time visit for sleep disorders of breathing at a sleep centre

IntroductionSleep-disordered breathing adversely affects daytime alertness and cognition. Obstructive sleep apnea (OSA) patients have several typical symptoms including habitual snoring, excessive daytime sleepiness, fatigue, lack of concentration, memory impairment, and at times psychological disturbances. We evaluated different aspects in the health related quality of life (HRQoL) in subjects referred to our sleep laboratory for their first examination for suspicion of OSA.MethodsOne hundred ninety-eight consecutive outpatients (152 M) (mean age 52.7 ± 12.8 years, range 18–82 years; mean BMI 31.0 ± 6.5 kg/m2, range 17.3-57.8 kg/m2) were evaluated with two self-reported questionnaires for HRQoL assessment: Psychological General Well-Being Index (PGWBI), that asses anxiety, depressed mood, positive well-being, self-control, general health, vitality, and 12-Item Short-Form Health Survey (SF-12), consisting assesses of Physical and Mental Component Summaries (PCS and MCS). Epworth Sleepiness Scale (ESS) was used to assess daytime sleepiness before nocturnal diagnostic examination.ResultsSubjects showed variable HRQoL scores. HRQoL was worse in women than men and it decreased with age. No relation was found with AHI severity (range 0–129 n/h). BMI and TSat90 (range 0–87.9%) affected physical health perception (SF-12 PCS). Furthermore TSat90 influenced PGWBI Vitality subscale. Subjects with ESS > 10 showed a worse HRQoL profile (p < 0.001) in SF-12 and in PGWBI. Multiple regression analysis showed that age, BMI and ESS were significant predictors of SF-12 PCS (p < 0.001; r2 = 0.23).ConclusionsA worse HRQoL perception among subjects referred for OSA suspicion was not related to disease severity. BMI and hypoxemia influenced only some HRQoL dimensions, while excessive daytime sleepiness worsens all HRQoL components considered.

Long-Term Health Related Quality Of Life and Symptom Burden In Patients With Acute Promyelocytic Leukemia Treated With All-Trans Retinoic Acid (ATRA) and Chemotherapy

▪ BackgroundThe combination of all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy regimens is currently considered the standard of care for newly diagnosed acute promyelocytic leukemia (APL) patients. This combination has greatly contributed to convert APL from a frequently fatal disease to a highly curable one. However, there is lack of data on the impact of such therapies on patients' health-related quality of life (HRQOL). ObjectiveThe main objective of this study was thus to investigate long-term HRQOL of APL patients previously treated with ATRA plus anthracycline-based chemotherapy. The physical and mental HRQOL profile of these patients was compared with that of matched control subjects from the general population to identify specific areas most in need of attention in long-term follow-up care. A secondary objective was to outline symptoms' burden from the patients' perspective. Patients and MethodsData were gathered through an ongoing multicenter survivorship study that recruits APL patients previously enrolled in two large GIMEMA trials (i.e., AIDA0493 and AIDA 2000). In both trials, APL patients were treated with ATRA plus Idrarubicin (AIDA). The main inclusion criterion was having survived the initial diagnosis for more than 5 years and being in complete remission (CR). Generic HRQOL was assessed with the SF-36 that consists of 36 items covering eight generic health status/QoL domains: physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and mental health (MH). All scales ranged between 0 and 100, with the higher scores representing better outcomes. Clinical significance was evaluated and eight points were considered to be a minimally important difference for the eight SF-36 scales. Mean SF-36 scores were compared to available national general population reference values (i.e., 1997 subjects without cancer) and all analyses were adjusted for age and gender. Symptom burden was assessed according to the M.D. Anderson Symptom Inventory (MDASI). Symptom severity was assessed for the following symptoms: fatigue, pain, sleep disturbance, drowsiness, poor appetite, shortness of breath, nausea, vomiting, dry mouth, numbness, difficulty remembering, distress and sadness. All items were rated on a numeric rating scale from 0 to 10, with the higher scores indicating a higher level of symptoms. These were categorized as “mild” (ratings between 0 and 3) and “moderate to severe” (ratings between 4 to 10). ResultsAnalysis is based on 136 adult APL patients who agreed to participate. At study participation, the mean age of patients was 52 years (55% males and 45% females) and the median time from diagnosis was 13 years (range: 4.5-20). Age and gender adjusted comparisons between APL patients and the general population norms revealed worse outcomes for the following scales: RP (P<.001) and RE (P<.001). Such differences were more than six times the magnitude of a clinically meaningful difference (i.e., at least 8 points), respectively for the physical (Δ=51 points) and the emotional scales (Δ=49 points) of the SF-36. Analysis within our patient cohort revealed that older APL patients (i.e., those aged more than 52 years) had a statically significant lower physical functioning (P<.001) and higher pain severity (P=.0448) than younger ones. Investigation of the HRQOL profile of patients by trial participation (i.e., AIDA 0493 vs. AIDA 2000) or time since diagnosis (cut-off median time of 13 years) revealed no difference in all scales of the SF-36. Fatigue was the most burdensome symptom being reported as moderate to severe in 35% of patients. Other frequently reported moderate to severe symptoms were: difficulty in remembering (30%), sadness and distress (29%). ConclusionsAlthough ATRA plus anthracycline-based chemotherapy regimens have greatly increased cure rates in APL, the HRQOL of these patients is heavily affected by the consequences of the disease and treatment, that persists many years after diagnosis and treatment. Disclosures:No relevant conflicts of interest to declare.

Profiling chronic myeloid leukemia patients reporting intentional and unintentional non-adherence to lifelong therapy with tyrosine kinase inhibitors

The main objective of this study was to outline key characteristics, including health-related quality of life (HRQOL) and symptoms, in 175 chronic myeloid leukemia (CML) patients reporting intentional or unintentional reasons for not fully adhering to imatinib therapy. There was a significant higher proportion of males in the unintentional group (P = 0.037). Also, in this group patients were on average younger (P = 0.046). Patients reporting intentional reasons had generally a worse HRQOL profile and a higher symptom severity than those who reported unintentional reasons for non-adherence. This study suggests that patients with suboptimal adherence are not a homogenous group, thus generalized approaches to improve medication-taking behaviors are not recommended.

Cross Sectional Assessment of Health Related Quality of Life (HRQoL) among Patients with Cancer in Malaysia

Health Related Quality of Life (HRQoL) is an important aspect in identifying cancer patients' perceptions of being diagnosed with cancer and the assessment of treatment outcomes. The present study aimedto assess the profile and predicators of HRQoL of Malaysian oncology patients. A cross sectional study adopting the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was conducted. All cancer patients attending Penang General Hospital between August-November 2011 were approached. Descriptive statistics were used to assess demographic and disease related characteristics of the patients. All analyses were performed using SPSS v 16.0. Three hundred and ninety three cancer patients met the inclusion criteria and were enrolled in the study. The mean age was 53.9 (SD±13) years. The cohort was dominated by females (n=260, 66.2%). Nearly half (n=190, 48.3%) of the participants were of Malay ethnicity, practicing Islam as their religion (n=194, 49.4%). Two hundred and ninety six (n=296, 75.3%) had beene diagnosed with cancer within six months to 3 years previously. The most common primary cancer site was breast (n=143, 36.4%). The mean Global Health Status (GHS) score was 60.7 (SD=21.3). Females (mean GHS score of 62.3, p=0.035) with Malay ethnicity (mean GHS score of 63.8, p=0.047), practicing Islam as their religion (mean GHS score of 63.0, p=0.011) had better GHS scores. Patients having medical insurance had good scores (mean 65.6, p=0.021). Marital status was significantly associated with GHS scores (p=0.022). Bone cancer patientshad the lowest mean GHS score of 49.2 (p=0.044). Patients at very advanced stages of cancer featured a low GHS mean score of 52.2 (p<0.001). The present study identified many demographic and disease related factors which may contribute to the HRQoL of cancer patients, pointing to the necessity for improved management of disease symptoms and provision of psychological and financial support.

Safety, efficacy, and health-related quality of life (HRQoL) of the investigational single agent orteronel (ortl) in nonmetastatic castration-resistant prostate cancer (nmCRPC).

5076 Background: Ortl is a selective, non-steroidal, oral 17,20-lyase inhibitor. Due to its lower inhibition of 17α-hydroxylase vs 17,20-lyase, ortl may allow steroid-free dosing. Ortl 300 mg BID was studied in nmCRPC patients (pts). Methods: Pts with nmCRPC, PSA ≥2 ng/mL (PSA ≥8 ng/mL if doubling time &gt;8 mo), and testosterone (T) &lt;50 ng/dL received ortl 300 mg BID until PSA progression, development of metastases (mets), or unacceptable toxicity. Primary endpoint: the percentage of pts with PSA ≤0.2 ng/mL at 3 mo. Secondary endpoints included safety, PSA kinetics, time to mets, and PFS (PSA progression, mets, or death), endocrine and bone markers, bone mineral density (BMD), HRQoL, cardiac and lipid assessments. Results: 38 pts enrolled: median PSA 11.7 ng/mL (range 2.6–67.8), T 8.5 ng/dL (1.4–17.3), and ACTH 20 ng/L (n=32; 0–47). Median therapy duration was 12.4 mo (0.7–27.8); 55% of pts were treated &gt;12 mo. 6 had dose reduction, 12 discontinued due to adverse events (AEs), including 2 for possible adrenal insufficiency. Gr 3 hypertension occurred in 7 pts (18%); various ≥Gr 3 AEs occurred in another 14 pts; 10 pts (26%) had serious AEs. At 3 mo, median T declined 89% to 0.78 ng/dL; median ACTH increased 171%; median cortisol declined 21%, but remained within normal range. 97% of pts had PSA declines; median PSA declined 83%. 18% had PSA ≤0.2ng/mL at 3 mo; 32% achieved PSA ≤0.2ng/mL as best response. Median time to PSA progression was 13.8 mo. Median PFS was 13.8 mo. Kaplan-Meier estimates of 1 and 2 y mets-free rates were 94% and 69%, respectively; 8 pts developed mets on study. The patient-reported Aging Male Symptoms Scale showed no decrease in overall scores, psychological, somatic, or sexual domains in 37, 34, 25, and 19 pts assessed at visits 2, 4, 7, and 13, respectively. Serum lipids, cardiac assessments, HbA1C, or bone-specific enzymes (N-telopeptide, or BMD) were not adversely affected. Conclusions: In pts with nmCRPC, long-term steroid-free ortl was feasible, with clinical activity as reflected by sustained marked declines in PSA and T, and had manageable toxicities, with no adverse effects on HRQoL, cardiac, bone or lipid profiles. Clinical trial information: NCT01046916.

Development, validation and reliability of a web‐based questionnaire to measure health‐related quality of life in dogs

To describe the development, preliminary validation and reliability testing of a shortened web-based form of GUVQuest, a structured questionnaire to measure health-related quality of life in dogs. The original 109 items were reduced using expert judgement and factor analysis. Validity was established by factor analysis and in a subsequent field trial using a "known groups" approach and classical test theory. Test-retest reliability was assessed using intraclass correlation coefficients. The instrument comprises 46 items each of which is rated by dog owners using a 7-point Likert scale. Factor analysis revealed a sensible structure containing four health-related quality of life domains (vitality, pain, distress and anxiety) accounting for 64·1% of the variability in the data. The field test involving 125 dogs demonstrated very good discriminative properties and intraclass correlation coefficient values of greater than 0·6. This is the first report of a valid and reliable companion animal health-related quality of life instrument, the contemporary approach to animal welfare measurement, which is presented in a web-based format, with automated production of a health-related quality of life profile. It offers major advantages to dog owners, practitioners and researchers.

Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention

Improving health-related quality of life (HRQoL) among people with epilepsy (PWE) has become the focus of various treatment programmes and behavioural interventions which continue to be challenging to both patients and healthcare professionals. To investigate the impact of SMS-based epilepsy education programme on PWE's HRQoL status and to determine the predictors for good HRQoL. Eligible epilepsy out-patients from three public hospitals in East Coast Peninsular Malaysia were randomized into two groups: intervention (IG) and control (CG). Patients in the CG were supplied with only printed epilepsy educational module, while those in the IG additionally received short message service (SMS) from the Mobile Epilepsy Educational System (MEES). The Malay Quality of Life in Epilepsy Inventory-30 (MQOLIE-30) was utilized for HRQoL assessment. Descriptive statistics, paired t test, analysis of covariance and multiple logistic regression were employed for data analyses (SPSS 16). One hundred and forty-four PWE were recruited for the study (age = 30.5 ± 11.8; unmarried = 60.4 %; education level ≤ SPM/Cambridge O' level = 76.4 %; illness duration > 5 years = 51.1 %). After controlling for possible confounders, IG exhibited positive changes in HRQoL profile compared to CG particularly in Seizure Worry, Overall Quality of Life, Emotional Well-Being, Social Functioning and Overall Score (p < 0.05). After adjusting for covariates, being employed and receiving additional SMS-based epilepsy education programme emerged as the significant predictors of good HRQoL among PWE. Receiving continuous SMS-based epilepsy information from the MEES seemed to generate positive impacts on PWE's overall HRQoL. This study has provided a basis for future innovations to inspire efforts in ensuring the welfare and HRQoL of PWE and their families.

Health-Related Quality of Life in Patients with Primary Immune Thrombocytopenia Compared with the General Population

AbstractAbstract 2056 Background:Recent international guidelines (Rodeghiero F, et al. Blood 113:2386–93, 2009) emphasize the importance of health-related quality of life (HRQOL) in patients with primary immune thrombocytopenia (pITP) and are advocating for more research in this area. However, very little research has been conducted on HRQOL of these patients. Aim:The main objective of this study was to identify specific limitations of HRQOL in pITP patients (ie, chronic, persistent and newly diagnosed patients) in comparison with their peers from the general population. Also, socio-demographic and clinical factors were considered to evaluate HRQOL impairment. Patients and Methods:Data were gathered through an ongoing multicenter observational study that recruits p-ITP patients. HRQOL was the primary endpoint of the study and was assessed with Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) that consists of 36 items covering eight generic health status/QoL domains: physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). All scales ranging between 0 and 100 with higher scores representing better outcomes. Two summary scores, namely the physical component summary (PCS) and the mental component summary (MCS) are derived from a weighted combination of the eight scales. Mean SF-36 scores were compared to available national general population reference values and analyses were adjusted for age and gender. Based on previous research, eight points were considered to be a minimally important difference (MID) for the first eight SF-36 scales, while a difference of two points was judged as MID for the PCS and the MCS scores. A score difference at least equal to MID was considered as a clinically meaningful difference. Socio-demographic, clinical and laboratory data were also collected to investigate their association with HRQOL outcomes. Univariate and multivariate linear regression analyses were used. Results:To date of the 256 pITP patients included in this study, 69%, 16% and 15%, were diagnosed with chronic, persistent and newly diagnosed pITP respectively. Present analysis is based on 175 patients with HRQOL data currently available. At study participation, mean age of patients was 54 years (67% female and 33% male). At least one comorbidity was present in 53% of patients. The median time from initial diagnosis to study entry was 0.3, 8 and 77 months respectively for newly diagnosed, persistent and chronic patients. Age and gender adjusted comparisons with general population norms revealed worse outcomes for the following scales: RP (P<.001), GH (P=.01), SF (P=.002), RE (P=.002). The largest clinically meaningful difference (Δ=13.4 points) was found for the RP domain with mean scores of 58.3 vs. 71.7 respectively for pITP patients and the general population. Age specific comparisons, (18–54, 55–64 and >65 years) suggested an almost uniform pattern in all scales with worse outcomes between pITP patients and population controls among the youngest groups. Statistically and clinically meaningful differences (ie, >8 points) were found in five out of the eight scales of the SF-36 in the youngest group of patients (18–54 years), when compared with their peers, while these differences were not present in the other age group categories. Comorbidity was the main factor influencing HRQOL by independently predicting worse HRQOL outcomes across all domains of the SF-36. SF-36 mean score differences in patients with or without comorbidity, were more than twice the magnitude of a clinically meaningful difference for PF and RP, being respectively: 69.7 vs. 87 and 51.3 vs. 68 points. Conclusions:This study suggests that HRQOL of p-ITP patients is far from optimal. In particular, role limitations (i.e., in work or other daily activities) due to physical health seems the major constraint faced by these patients when compared to their peers in the general population. Comorbidity seems the major factor associated with a poorer HRQOL profile. These findings need to be confirmed with a larger sample size and will eventually help guide the development of patient-centered supportive care programs. Disclosures:No relevant conflicts of interest to declare.

Health-related quality of life in Egyptian patients after liver transplantation

Introduction-Aim. Health-Related Quality of Life (HRQOL) has become an important focus of patient care and clinical outcomes research with the improvement in patient and graft survival after liver transplantation (LT). The current study was designed to evaluate the post-transplant HRQOL profiles using the Liver Disease Quality of Life 1.0 (LDQOL 1.0) Questionnaire and demonstrate the possible effect of peri-transplant clinical covariates on these profiles.Material and methods. Participants included pre-transplant group (waiting-list patients n = 50) and post-transplant group (mean 5 ± 4 years after deceased or living donor LT n = 103) who were recruited from 3 specialized centers in Egypt. We applied the LDQOL 1.0 questionnaire; a 111-item containing the Short Form-36 version 2.0 (SF-36v2) as a generic component supplemented by 75 disease-specific items. The etiology of cirrhosis, co-morbidities, model for end-stage liver disease (MELD), Child-Pugh class and post-operative complications were analyzed.Results. All recipients had significant higher HRQOL scores than patients in waiting-list using both questionnaire components. Recipients with pre-LT MELD ≥ 15, Child-Pugh class C, history of hepatocellular carcinoma (HCC) demonstrated low HRQOL scores. Recipients without post-operative surgical complications had a statistically better HRQOL using the disease-specific, but not the SF-36v2 component. On the other hand, both components demonstrated non-significant lower scores in recipients with rejection episodes, cytomegalovirus (CMV) infection and hepatitis C recurrence had compared to those without medical complications.Conclusion. Generally HRQOL improves dramatically after LT as assessed by LDQOL questionnaire. Moreover, combined questionnaires can provide accurate information about the possible impaired HRQOL post-LT due to pre-transplant disease severity and post-operative complications.