Health-related Quality Of Life Profile Research Articles

Health related quality of life in Middle Eastern children with beta-thalassemia

BackgroundThalassemia is a common disorder worldwide with a predominant incidence in Mediterranean countries, North Africa, the Middle East, India, Central Asia, and Southeast Asia. Whilst substantial progress has been made towards the improvement of Health related quality of life (HRQoL) in western countries, scarce evidence-based data exists on HRQol of thalassemia children and adolescents living in developing countries.MethodsWe studied 60 thalassemia children from Middle Eastern countries with a median age of 10 years (range 5 to 17 years). HRQoL was assessed with the Pediatric Quality of Life Inventory (PedsQL) 4.0. The Questionnaire was completed at baseline by all patients and their parents. The agreement between child-self and parent-proxy HRQoL reports and the relationship between HRQoL profiles and socio-demographic and clinical factors were investigated.ResultsThe scores of parents were generally lower than those of their children for Emotional Functioning (mean 75 vs 85; p = 0.002), Psychosocial Health Summary (mean 70.3 vs 79.1; p = 0.015) and the Total Summary Score (mean 74.3 vs 77.7 p = 0.047). HRQoL was not associated with ferritin levels, hepatomegaly or frequency of transfusions or iron chelation therapy. Multivariate analysis showed that a delayed start of iron chelation had a negative impact on total PedsQL scores of both children (p = 0.046) and their parents (p = 0.007).ConclusionsThe PedsQL 4.0 is a useful tool for the measurement of HRQoL in pediatric thalassemia patients. This study shows that delayed start of iron chelation has a negative impact on children’s HRQoL.

Health‐related quality of life in subjects with HCV/HIV coinfection: results from ACTG 5178 study

Although health-related quality of life (HRQOL) is diminished in HCV/HIV, the relationship between virologic response and maintenance therapy with HRQOL in this population is unknown. ACTG 5178 was a phase 2, randomized trial, with three steps - Step 1: all subjects received pegylated interferon (PEG-IFN)/ribavirin (P/R) for 12 weeks. Step 2: subjects who failed to achieve early viral response (EVR) were randomized to PEG-IFN or observational control for an additional 72 weeks. Step 3: subjects with EVR from step 1 continued on P/R for a total of 72 weeks with 24 weeks follow-up off-therapy. HRQOL, symptom distress and depression levels were measured at multiple time points. In step 1 (n = 329), there was a significant decline in HRQOL in all dimensions. In step 3 (n = 169), the overall HRQOL and three of its eight dimensions (general health, role function and pain score) were increased, and achievement of sustained virologic response was associated with increased general health and cognitive function. In step 2 (n = 85), there was no significant change in HRQOL and no significant difference between groups (PEG-IFN vs observational control). There was a significant decline in HRQOL during the initial 12 weeks of therapy. Thereafter, the HRQOL profile differed for subjects with EVR vs without EVR. Maintenance therapy with PEG-IFN had no impact on the HRQOL.

The Relationship Between Health-Related Quality-of-Life and Disability in Patients with Controlled Epilepsy

The aims this study were to assess the impact of epilepsy on the health-related quality-of-life (HRQoL) of patients and on patterns of disability and to describe the relationship between disability and HRQoL in adult patients with controlled epilepsy. Disability was measured with the World Health Organization Disability Assessment Schedule, second version (WHO-DAS II), whereas HRQoL was measured with the 36-item Short-Form Health Survey (SF-36). The relationships between SF-36 and WHO-DAS II were evaluated with Pearson correlation. The impact of epilepsy on disability and HRQoL was assessed by comparing WHO-DAS II and SF-36 scores with the Italian normative values and by evaluating different disability and HRQoL profiles in patients self-reporting change in health state against those reporting no change. Few differences between patients' and normative scores were observed. In particular, patients with a stable health state reported higher HRQoL and lower disability status, compared with those reporting an improvement or a decline in health state. The relationships between WHO-DAS II and SF-36 were significant but were generally low or moderate. Disability and HRQoL scores of patients with controlled epilepsy were not significantly different compared with those of the general population, in particular among stable patients. Measures of HRQoL and disability evaluate different psychosocial aspects of epilepsy and can be used jointly to evaluate outcomes.

Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment

ObjectivesTo compare health-related quality of life (HRQoL) before and after treatment with etanercept in patients with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and psoriasis using spydergram representations.MethodsData...

Comparing higher order models for the EORTC QLQ-C30

PurposeTo investigate the statistical fit of alternative higher order models for summarizing the health-related quality of life profile generated by the EORTC QLQ-C30 questionnaire.MethodsA 50% random sample was drawn from a dataset of more than 9,000 pre-treatment QLQ-C30 v 3.0 questionnaires completed by cancer patients from 48 countries, differing in primary tumor site and disease stage. Building on a “standard” 14-dimensional QLQ-C30 model, confirmatory factor analysis was used to compare 6 higher order models, including a 1-dimensional (1D) model, a 2D “symptom burden and function” model, two 2D “mental/physical” models, and two models with a “formative” (or “causal”) formulation of “symptom burden,” and “function.”ResultsAll of the models considered had at least an “adequate” fit to the data: the less restricted the model, the better the fit. The RMSEA fit indices for the various models ranged from 0.042 to 0.061, CFI’s 0.90–0.96, and TLI’s from 0.96 to 0.98. All chi-square tests were significant. One of the Physical/Mental models had fit indices superior to the other models considered.ConclusionsThe Physical/Mental health model had the best fit of the higher order models considered, and enjoys empirical and theoretical support in comparable instruments and applications.

Health-Related Quality of Life Profile and Request of Prognostic Information on Survival At the Time of Diagnosis in Patients with High-Risk Myelodysplastic Syndromes

Abstract 2078 Background:Health-related quality of life profile (HRQOL) of patients diagnosed with high-risk myelodysplastic syndromes (MDS) can be compromised already at the time of diagnosis before receiving any kind of treatment. Clinical decision-making is challenging due to the poor prognosis and no data exist on the possible relationships between patient's HRQOL and the request of prognostic information on survival during consultation. Aim:The main objectives were to assess preferences for prognostic information of patients with high-risk MDS and the relationship between such preferences and patient characteristics including HRQOL. To date no such evidence exists in this population.Patients and Methods: Data were gathered through an ongoing international prospective observational study that recruits newly diagnosed patients with MDS. These patients typically have a limited life expectancy. At the time of diagnosis, and during one of the first clinical consultations in which treatment options were discussed, patients completed the European Organization for Research and treatment of Cancer, Quality of life Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is a psychometrically robust generic HRQOL cancer measure assessing both symptoms and functional aspects. Physicians also completed an extensive survey about their patient's preference for involvement in treatment decisions and whether the patient explicitly requested prognostic information for survival. Associations between request for prognostic information, HRQOL socio-demographic characteristics (i.e., living arrangements, age, gender, education) and clinical data including: performance status, comorbidity and disease severity (i.e. IPSS risk category intermediate 2 vs. high risk) were investigated using Fisher's exact test and Wilcoxon-Mann-Whitney test as appropriate. Results:Overall, 184 patients (36% female and 64% male) were analyzed. Mean age of patients was 70 years (range: 31–88). 65% explicitly requested information about expected survival at the time of diagnosis. The symptom profile of patients requesting prognostic information was better than those who did not in 7 out of the 8 symptoms evaluated. The largest clinically meaningful difference was found for fatigue with a mean score of 39 (SD:26) and 52 (SD:28) respectively for those requesting prognostic information versus those who did not. Request for prognostic information was significantly associated with younger age (P=.01) and fewer comorbidities (P=.04). In addition, better physical functioning (P=.009), better role functioning (P=.002) and a lower level of fatigue (P=.002) were also associated with a request for prognostic information during consultation. Additional supportive analysis revealed that patients with a higher overall mean symptom score did not request information about survival (P=.02). Conclusion:These data suggest that the majority of patients with high-risk MDS request prognostic information on survival from their physicians at the time of diagnosis. There is also an indication that patients who are more likely to request such information are those who are in better health condition reporting higher functional abilities and lower symptoms. Disclosures:No relevant conflicts of interest to declare.

Melphalan, Prednisone and Lenalidomide Followed by Lenalidomide Maintenance Displays Treatment Characteristics Favourable to Global Quality of Life in Newly Diagnosed Multiple Myeloma (NDMM) Patients ≥ 65 Years,

Abstract 3988 Background:Melphalan, prednisone and lenalidomide followed by lenalidomide maintenance (MPR-R) demonstrated higher response rates (ORR; 77% vs. 50%, p <.001; VGPR or better: 32% vs. 12%, p <.001) and significantly reduced the risk of disease progression (hazard ratio [HR] = 0.423, p <.001) vs. MP alone [Palumbo, 2010]. Alongside efficacy considerations, analyses on health-related quality of life (HRQoL) may help more fully establish a regimen’s overall treatment profile. HRQoL improvements with MPR-R were observed during MPR induction as well as lenalidomide maintenance, documenting a well-balanced profile in terms of efficacy, tolerability and HRQoL [Dimopoulos, 2011]. Alternative findings on novel NDMM treatment have shown efficacy of melphalan, prednisone and bortezomib (VMP) treatment to be associated with an intermittent deterioration in patients’ HRQoL [Dhawan, 2009]. Methods:A mixed effects model was developed based on parameters pre-selected as potentially clinically relevant in impacting HRQoL. Models were run on six domains pre-selected based on clinical relevance: Global QoL, Physical Functioning, Fatigue and Pain (from EORTC QLQ-C30), and Disease Symptoms and Side Effects of Treatment (from EORTC MY20). Cycle 16 was determined as the last observation time point with a statistically meaningful sample size at time of follow-up (May 2010). Following explanatory variables were included: time-dependant covariates at individual HRQoL measurement time points (i.e. cycle 4, 7, 10, 13 and 16), treatment group (MPR-R vs. MP), gender (Female vs. Male), age, baseline QoL, Partial Response (PR) vs. Stable Disease (SD) and Very Good Partial Response or better (≥VGPR) vs. SD, Progressive Disease (PD) and Discontinuation (DC). Neutropenia and anemia, both Grade 3 or 4, were considered the clinically most relevant safety parameters. Main results for Global QoL are reported, with results from other domains found to be comparable. Results:Across all time-dependant covariates, a statistically significant reduction on Global QoL (−4.63; p=.004) was observed at Cycle 4. Being female vs. male significantly reduced Global QoL by -−.07 (p=.026). Each additional life year was found to lower Global QoL b− −0.40 points (p=.034). Baseline Global QoL was also significant, each additional score point leading to +0.30 (p <.001). A response level of ≥VGPR vs. SD increased Global QoL by 9.11 (p=.023); Progressive Disease (PD) reduced Global QoL by -−.34 score points (p <.001). All other pre-defined variables did not significantly impact Global QoL. Clinically meaningful changes for Global QoL in the underlying patient population have been determined to constitute at least a 7-point change [Dimopoulos, 2011]. Progressive disease (reducing Global QoL), respectively ≥VGPR (increasing Global QoL) exerted clinically meaningful changes, as did anemia grade 3–4, which had a clinically meaningful, but not statistically significant negative impact (−9.85; p=.057). Although no significant direct effect of MPR-R over MP on Global QoL was detected in the underlying model, MPR-R displays properties which favor an improved HRQoL profile, including a stronger delay in PD and higher % of VGPR vs. MP patients. Furthermore, certain properties more frequently observed with MPR-R than MP (neutropenia grade 3 or 4 and discontinuation, DC) were shown not to have a significant impact on HRQoL. Anemia grade 3 or 4, exerted a clinically meaningful negative effect but was not significantly more often observed with MPR-R compared to MP (24% vs. 17%, p= 0.091). Conclusions:More patients achieved ≥VGPR when receiving continuous MPR-R treatment than those receiving MP. In the above pooled analysis, ≥VGPR was shown to improve Global QoL in a clinically meaningful and statistically significant way. Furthermore, progression was also shown to negatively impact Global QoL (−8.34; p <.001), with MPR-R significantly reducing the risk of disease progression over MP. Delaying progression with continuous MPR-R therefore helps to maintain a high Global QoL. [Display omitted] Disclosures:Dimopoulos:Celgene: Consultancy, Honoraria. Off Label Use: Lenalidomide in newly diagnosed multiple myeloma. Palumbo:Celgene: Consultancy, Honoraria; Janssen-Cilag: Consultancy, Honoraria; Ortho-Biotech: Honoraria. Hajek:Celgene: Honoraria; Janssen-Cilag: Honoraria; Merck: Honoraria. Petrucci:Celgene: Honoraria. Lewis:Celgene: Employment, Equity Ownership. Millar:Celgene: Consultancy. Zhang:Celgene: Employment, Equity Ownership. Mei:Celgene: Employment, Equity Ownership. Delforge:Celgene: Consultancy, Honoraria, Speakers Bureau; Janssen-Cilag: Consultancy, Honoraria, Speakers Bureau.

Concordance between severity of disease, prevalence of nonmotor symptoms, patient-reported quality of life and disability and use of medication in Parkinson’s disease

The aim of this study was to test the concordance between disease severity, prevalence of nonmotor symptoms, age, health-related quality of life (HRQoL), disability and medication use in patients with Parkinson's disease (PD). Severity was classified with the Hoehn and Yahr (HY) scale and Levodopa Equivalent Daily Dose (LEDD) calculated. HRQoL was evaluated with the SF-36, disability with the WHO-DAS II and nonmotor symptoms with the NMSQuest. Patients were clustered using SF-36 and WHO-DAS II into three groups covering the continuum from low disability and HRQoL, to severe disability and HRQoL decrement. Contingency Coefficient were used to verify the relationships between clusters and HY stage; ANOVA to evaluate differences in NMS, age and LEDD between clusters; odds ratio to test the likelihood of taking levodopa or dopamine agonist and being member of the three clusters; t test to evaluate differences in LEDD between patients with HY ≥3 or ≤2. Eighty-six patients were clustered: 48 had low disability and HRQoL decrement, 18 intermediate disability and HRQoL decrement and 20 high disability and HRQoL decrement. A significant relationship was found between PD severity groups, HRQoL and disability profiles. No differences for age and LEDD were observed in the three groups, and those with more disability and lower HRQoL reported a higher number of nonmotor symptoms; patients in HY ≥3 were prescribed higher doses of drugs. In conclusion, we found a substantial concordance between PD staging, prevalence of nonmotor symptoms and patient-reported HRQoL and disability measures. In our opinion, the SF-36 and the WHO-DAS II can be used for profiling patients.

Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population

AbstractThe main objective of this study was to investigate whether patients with chronic myeloid leukemia (CML) in treatment with long-term therapy imatinib have a different health-related quality-of-life (HRQOL) profile compared with the general population. In total, 448 CML patients were enrolled, and the SF-36 Health Survey was used to compare generic HRQOL profiles. Symptoms were also assessed. HRQOL comparisons were adjusted for key possible confounders. The median age of patients was 57 years and the median time of imatinib treatment was 5 years (range 3-9 years). The largest HRQOL differences were found in younger patients. In particular, patients aged between 18 and 39 years had marked impairments in role limitations because of physical and emotional problems, respectively: −22.6 (P < .001), −22.3 (P < .001). Patients with CML age 60 or older had a HRQOL profile very similar to that reported by the general population. Women had a worse profile than men when each were compared with their peers in the general population. Fatigue was the most frequently reported symptom. The HRQOL of CML patients is comparable with that of population norms in many areas, however, younger and female patients seem to report the major limitations.

Health-Related Quality of Life Profiles Among Family Caregivers of Patients With Schizophrenia

This cross-sectional study aims to determine and compare health-related quality of life profiles of schizophrenia family caregivers on the basis of their sociodemographic characteristics. Thirty outpatient family caregivers completed the generic 36-Item Short Form Health Survey instrument (male = 53.5%; mean age = 51 years; married = 76.7%). The highest mean score was reported for social functioning while role limitation-emotional was rated the worst. Significantly better health-related quality of life profiles were demonstrated by caregivers who were male, younger than 50 years, adequately educated, employed, and without health problems and were receiving monthly income. Understanding of on health-related quality of life matters for family caregivers is crucial to improve the quality of care for schizophrenia patients.

Health‐Related Quality of Life, Disability and Severity of Disease in Patients With Migraine Attending to a Specialty Headache Center

The impact of migraine on patients' daily life has been evaluated in several studies. The relationship between disability and health-related quality of life (HRQoL) in patients with migraine, however, has not been systematically evaluated. To assess the impact of migraine on patients' HRQoL and disability patterns and to describe the relationship between disability and HRQoL in patients with migraine attending a specialty Italian headache center according to the biopsychosocial model of disability endorsed by the International Classification of Functioning, Disability and Health. In this observational study, adult patients with migraine were consecutively recruited. Disability was measured with the MIDAS (Migraine Disability Assessment) and the WHO-DAS II (World Health Organization Disability Assessment Schedule), HRQoL with the SF-36 (Medical Outcome Survey 36-item Short-Form Health Survey). Spearman's rank correlation between MIDAS score, SF-36 and WHO-DAS II scales was performed to evaluate the relationships between quality of life and disability. The impact of migraine on disability and HRQoL was assessed by comparing WHO-DAS II and SF-36 scores against Italian normative values, and by evaluating the different disability and HRQoL profiles in patients with different severity of migraine, defined according to migraine frequency and pain intensity. A total of 102 patients with migraine (87 females) were enrolled. Mild to moderate correlations were reported between WHO-DAS II and SF-36's PCS (r = -0.67, P < .01) and MCS (r = -0.36, P < .05) scales; MIDAS score correlations to SF-36's PCS (r = -0.44, P < .01) and MCS (not significant) were lower than WHO-DAS II summary score. The correlation between MIDAS score and the WHO-DAS II summary score was mild (r = -0.36, P < .05). The majority of HRQoL and disability scales (with the exception of SF-36's Physical Functioning, and WHO-DAS II Getting along with people scales) scored significantly lower than normative values. A trend towards worsening of both HRQoL and disability, consistent with increasing migraine severity, was reported (Mann-Whitney's U = 119.5 for MIDAS; U= 113.0 for WHO-DAS II summary score, both with P < .01; U = 152.9 for PCS; U = 171.0 for MCS, both with P< .05) In migraineurs attending an Italian specialty headache clinic, disability scores were worse and HRQoL scores lower than those of the general population, and worsened consistently with increased migraine severity. Measures of HRQoL and disability evaluate different psychosocial aspects of migraine and researchers should continue to employ them in public health and clinical research on migraine. They provide information on a poorly recognized part of migraine's burden, where economic impact is minimal but there are important effects on patients' daily lives in terms of interpersonal relationships, perceived quality of life and emotional status.

Quality of Life after Brain Injury (QOLIBRI): Scale Validity and Correlates of Quality of Life

The QOLIBRI (Quality of Life after Brain Injury) is a novel health-related quality-of-life (HRQoL) instrument specifically developed for traumatic brain injury (TBI). It provides a profile of HRQoL in six domains together with an overall score. Scale validity and factors associated with HRQoL were investigated in a multi-center international study. A total of 795 adults with brain injury were studied from 3 months to 15 years post-injury. The majority of participants (58%) had severe injuries as assessed by 24-h worst Glasgow Coma Scale (GCS) score. Systematic relationships were observed between the QOLIBRI and the Glasgow Outcome Scale-Extended (GOSE), Hospital Anxiety and Depression Scale (HADS), and SF-36. Within each scale patients with disability reported having low HRQoL in two to three times as many areas as those who had made a good recovery. The main correlates of the total QOLIBRI score were emotional state (HADS depression and anxiety), functional status (amount of help needed and outcome on the GOSE), and comorbid health conditions. Together these five variables accounted for 58% of the variance in total QOLIBRI scores. The QOLIBRI is the first tool developed to assess disease-specific HRQoL in brain injury, and it contains novel information not given by other currently available assessments.

Gastrointestinal tolerability and quality of life in antiretroviral-naïve HIV-1-infected patients: data from the CASTLE study

Most ritonavir-boosted protease inhibitor (PI)-based antiretroviral regimens offer comparable levels of virological efficacy. Thus, the tolerability of the regimen becomes a distinguishing factor with implications for patient quality of life (QoL), treatment adherence, and clinical outcome. This article describes results from the CASTLE study (comparing once-daily atazanavir/ritonavir [ATV/RTV] with twice-daily lopinavir/ritonavir [LPV/RTV], both in combination with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-infected patients) and an evaluation of the impact of gastrointestinal (GI) complications of treatment on patient QoL, as measured by the irritable bowel syndrome (IBS) QoL questionnaire (IBS-QoL). Changes in IBS-QoL from baseline over time (to week 24) were classified as: “Improvement” (≥2-point positive change from baseline), “No change” (<2-point change), or “Worsening” (≥2-point negative change). Data were collected on GI adverse events (AEs) and use of GI medications. Of the 599 patients with IBS-QoL-evaluable data through week 24, fewer patients in the ATV/RTV group than in the LPV/RTV group experienced grade 2–4 treatment-related GI AEs including diarrhea (3% versus 10%), nausea (5% versus 7%), and vomiting (<1% on both arms). Nearly three times as many patients receiving LPV/RTV used GI medications. ATV/RTV was associated with an increase in overall IBS-QoL scores and more patients receiving ATV/RTV than LPV/RTV experienced improvement in IBS-QoL through week 24. In contrast to LPV/RTV, ATV/RTV treatment was associated with earlier and more positive improvements in QoL scores across CD4 sub-groups. Differences in the health-related QoL profile between ATV/RTV and LPV/RTV may be important when selecting PI-based antiretroviral regimens.

Health-related Quality of Life in Vacuum-Assisted Breast Biopsy: short-term effects, long-term effects and predictors

BackgroundThe impact of Vacuum-assisted breast biopsy (VABB, 11-Gauge) upon Health-related Quality of Life (HRQoL) remains an open field. This study aims to: i) assess short-term (4 days after VABB) responses in terms of HRQoL after VABB, ii) evaluate long-term (18 months after VABB) responses, if any, and iii) examine whether these responses are modified by a variety of possible predictors (anthropometric, sociodemographic, lifestyle habits, breast-related parameters, reproductive history, VABB-related features and complications, seasonality).MethodsThis study included 102 eligible patients undergoing VABB and having benign lesions. A variable number of cores (24-96 cores) has been excised. HRQoL was assessed by EQ-5D and SF-36® questionnaires: i) in the morning of the VABB procedure day (baseline measurement), ii) four days after VABB (early post-biopsy measurement) and iii) 18 months after VABB (late post-biopsy measurement). Statistical analysis comprised two steps: i. evaluation of differences in EQ-5D/SF-36 dimensions and calculated scores (baseline versus early post-biopsy measurement and baseline versus late post-biopsy measurement) and ii. assessment of predictors through multivariate linear, logistic, ordinal logistic regression, as appropriate.ResultsAt baseline patients presented with considerable anxiety (EQ-5D anxiety/depression dimension, EQ-5D TTO/VAS indices, SF-36 Mental Health dimension). At the early post-biopsy measurement women exhibited deterioration in Usual Activities (EQ-5D) and Role Functioning-Physical dimensions. At the late measurement women exhibited pain (EQ-5D pain/discomfort and SF-36 Bodily Pain), deterioration in Physical Functioning (SF-36 PF) and overall SF-36 Physical Component Scale (PCS). Mastalgia, older age and lower income emerged as significant predictors for baseline anxiety, whereas seasonality modified early activities-related responses. Pain seemed idiosyncratic.ConclusionsThe HRQoL profile of patients suggests that VABB exerts effects prior to its performance at a psychological level, immediately after its performance at a functioning-physical level and entails long-term effects associated with pain.

Health-related quality-of-life profiles in nonalexithymic and alexithymic subjects from general population

Objective Earlier studies have shown an association between alexithymia and health-related quality of life (HRQoL). There has been some controversy as to whether this is attributable solely to psycho-social domains of HRQoL or also to physical domains. Furthermore, there are no studies on HRQoL profiles in representative general population samples controlling for sociodemographic variables, mental health and somatic health. Methods The study forms part of the Health 2000 Study. Altogether 5090 participants from general population, aged 30-97 years, filled in the 20-item Toronto Alexithymia Scale and the 15D HRQoL scale. Depressive and anxiety disorders were assessed in a structured psychiatric interview. Physical health was examined by physicians. The 15-dimension HRQoL profiles of both alexithymic and non-alexithymic subjects were obtained by analysis of covariance, controlling for sociodemographic and health-related variables. Results The alexithymic group had significantly ( P<.001) lower mean scores on every dimension of the 15D even after controlling for confounding demographic variables, somatic diagnoses and depressive and anxiety disorders. The differences were greatest in the psycho-social domains. Conclusions Alexithymia seems to be a personality trait with a statistically significant association to every dimension of HRQoL, not only to psychosocial domains. However, the associations between alexithymia and some somatic dimensions may be of little clinical significance.

Concordance between severity of disease, disability and health-related quality of life in Myasthenia gravis

Aim of this study is to verify whether there is concordance between disease's severity, health-related quality of life (HRQoL) and disability in patients with myasthenia gravis (MG). 102 MG patients were clustered on the basis of HRQoL and disability scores into three groups: low disability and low HRQoL decrement (51 patients), intermediate disability and HRQoL decrement (28 patients), severe disability and high HRQoL decrement (23 patients). Cross tabulation with symmetric measures (Cramer's V and Contingency Coefficient) was used to verify the relationships between disease severity groups, based on the Myasthenia Gravis Foundation of America (MGFA) criteria, and obtained clusters. Results confirm a significant relationship between MG severity groups, HRQoL and disability profiles. In our opinion, HRQoL and disability instruments should be employed in clinical trials to match efficacy of treatments, measured on symptoms' reductions only, with their effects on patients' disability and HRQoL.

Depressive symptoms impacting on health-related quality of life in early Parkinson's disease: Results from Chinese l-dopa exposed cohort

Objective To investigate the impact of depressive symptoms on health-related quality of life (HR-QOL) in a group of patients with early Parkinson's disease (PD). Methods A 20-item scale, the Center for Epidemiologic Studies Depression Scale (CESD) and a 36-item questionnaire, the medical outcomes study short form (SF-36) were administered as part of baseline assessment of a clinical trial in PD, enrolling 391 early-stage, l-dopa exposed PD patients in China. We used multiple regression models to examine the relationship of depressive symptoms, measured by the CESD with HR-QOL, as measured by the SF-36. The SF-36 score of the depressed patients was compared with those non-depressed, as well. Results A total of 146 (37.3%) patients screened positive for depression. Compared with those non-depressed, depressed patients had lower scores in all dimensions of SF-36 profile ( p < 0.001). Multiple regression analysis revealed that depressive symptoms, measured by CESD, increased our ability to explain the variance of SF-36 total score by 34.5%. Additionally, depressive symptom is the only variable which has the predictive value not only for total SF-36 total score, but also for each subdimension score of SF-36 profile. Conclusion Depressive symptoms are common early in the disease, having a substantial impact on patients’ HR-QOL, affecting many areas other than the obvious mental health dimension of the HR-QOL profile. Our results highlight the broad importance of treating depression in this population.

Health-related quality of life, faecal continence and bowel function in rectal cancer patients after chemoradiotherapy followed by radical surgery

To evaluate health-related quality of life (HRQOL), faecal continence and bowel function of patients with rectal cancer who underwent preoperative chemoradiotherapy (pCRT) in a cross-sectional setting. Out of 185 consecutive patients who underwent pCRT for rectal cancer from 1994 to 2004 at a single institution, 101 were eligible for the study. Causes of exclusion were: death (n = 38), not radical surgery or recurrence (n = 21), presence of stoma at the time of the survey (n = 15), lost to follow-up (n = 6) and miscellaneous (n = 4). Eligible patients were asked to complete: the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, the disease specific colorectal module (EORTC QLQ-CR38) and faecal incontinence and bowel function questionnaires. HRQOL outcomes were compared with reference data from the general population, and the association among clinical variables and HRQOL was also investigated with linear regression analyses. Questionnaires were completed by 80% of eligible patients. Compared to population-based norms, patients showed clinically meaningful worse outcomes in terms of constipation and diarrhoea. Stool fractionation (p < 0.01) and use of enema/laxative (p < 0.01) were negatively associated with global health status/QOL. Urgency negatively affected physical (p < 0.01), role (p < 0.01) and social functioning (p < 0.01). Sensation of incomplete evacuation negatively affected social functioning (p < 0.01). Although HRQOL profile of these patients is broadly similar to that of healthy subjects, there are still important limitations in terms of key symptoms. The use of validated questionnaires is crucial to provide standardised information on relevant health status areas.

Converting the SF-12 into the EQ-5D

For cost-utility analysis, analysts need a measure that summarizes health-status utilities in a single index of health-related quality of life (HR-QOL). It is common to find in clinical studies that only an HR-QOL profile measure such as the SF-36 is included, but not the summary HR-QOL index. Therefore, the economist's usual practice is to reprocess the profile data into a single index format. Several 'after-market' tools are available to convert the SF-36 or SF-12 into a single form with or without utility-weighting metric property. However, there has been no consensus with regard to a regression method that should be recommended for such a mapping task. To report on the performance of different regression methods that have previously been applied to the conversion of SF-12 data in the analysis of a single common dataset. The mapping between the SF-12 and EQ-5D is the focus. The data were adopted from the Medical Expenditure Panel Survey 2003 where 19 678 adults completed both EQ-5D and SF-12 questionnaires. Four econometric techniques, namely ordinary least squares (OLS), censored least absolute deviation, multinomial logit model and two-part model regressions were investigated together with two main types of model specifications: item-based and summary score-based. The performance of each examined model was judged by various criteria, including its estimated mean, the size of mean absolute error and the number of errors. Among four compared econometric techniques, OLS regression was the most accurate model in estimating the group mean. Models with item-based model specification performed better than those with summary score-based regardless of the chosen econometric technique. Nevertheless, the accuracy of OLS deteriorates in older and less healthy subgroups. The results also suggested that the two-part model, which addresses the heterogeneity issue, performs better in these vulnerable subgroups. None of the mapping methods included in the current study are suitable for estimating at the individual level. The methodology exemplified here has wider applicability and might just as readily be applied to other members of the SF family or indeed to other profile measures of HR-QOL. However, it is recommended that a preference-based, single index measure of HR-QOL should be included in the clinical studies for the purpose of economic evaluation.

Profile of health‐related quality of life in Nigerian stroke survivors

No study using a stroke-specific measure has been previously conducted to determine the profile of health-related quality of life (HRQOL) in Nigerian stroke patients. Such a study is pre-requisite to planning of patient-centered rehabilitative care aimed at maximizing HRQOL improvement. Our objectives were to develop and validate a stroke-specific HRQOL measure, and determine the profile of HRQOL using it. The HRQOL in stroke patients (HRQOLISP) questionnaire was developed and administered to 100 stroke patients and a control group of 100 age- and gender-matched healthy adults. The Stroke Levity Score (SLS) and modified Rankin Scale (mRS) were applied to measure stroke severity and disability respectively. The HRQOLISP surpassed the Nunnaly's criterion for reliability and was able to discriminate between stroke (HRQOLsum = 73.5 +/- 9.1) and normal subjects (HRQOLsum = 84.4 +/- 6.9, P = 0.002). It differentiated strokes of various severities in the physical dimension (physical, psychological, cognitive and social domains). SLS and mRS correlated only to the domains in the physical dimension. The HRQOLISP demonstrated good content, construct and discriminant validity and internal consistency reliability. Stroke had a multifaceted effect on HRQOL, which was more pronounced in the physical dimension.