Improvement In Health-related Quality Of Life Scores Research Articles

The Effectiveness of Darbepoetin Alfa Administered Every 3 Weeks on Hematologic Outcomes and Quality of Life in Older Patients With Chemotherapy-Induced Anemia

Chemotherapy-induced anemia (CIA) may substantially impact the health-related quality of life (HRQoL) of older cancer patients. This exploratory analysis evaluated the effect of darbepoetin alfa administered as a fixed dose (300 microg) every 3 weeks (Q3W) on hematologic outcomes, HRQoL, and safety in older (> or =65 years old) versus younger (<65 years old) patients with CIA (hemoglobin <11 g/dl). Patients were categorized by age at screening: <65, > or =65 to <70, > or =70 to <75, > or =75 to <80, and > or =80 years old. Patients who received at least one dose of darbepoetin alfa were included in the analysis; of 1,493 patients, 724 were > or =65 years old. Age did not appear to influence hematologic outcomes after treatment with darbepoetin alfa; in all age categories, similar percentages of patients (78%-80%) achieved the target hemoglobin in approximately the same time (4-5 weeks). Also, the percentage of patients in each age category who received RBC transfusions was reduced from 10%-13% in month 1 to 2%-4% in month 4. Although younger patients reported the greatest improvement in HRQoL scores, approximately one half in each older age category reported clinically significant improvement in fatigue, and improvement in the Energy and Overall Health Assessment and Work Productivity and Activity Impairment scales. There were no treatment-related deaths. Treatment-related thromboembolic events were reported by <1% of patients <65 years old and <1% of patients > or =65 to <70 and > or =70 to <75 years old. Darbepoetin alfa Q3W appeared well tolerated and effective for treating older patients with CIA.

Quality of life rapidly improves with budesonide therapy for active Crohn's disease

Our aims were to assess the impact on health-related quality of life (HRQOL) of a controlled ileal release (CIR) formulation of budesonide in active Crohn's disease (CD) and further define the role of HRQOL, using the Inflammatory Bowel Disease Questionnaire (IBDQ), in assessing outcome in CD. A randomized trial was conducted in 258 patients with active ileal or ileocecal CD. Budesonide CIR 1.5 mg, 4.5 mg, 7.5 mg, or placebo was given b.i.d. for 8 weeks. IBDQ score changes were compared among groups. Correlations for IBDQ and Crohn's Disease Activity Index (CDAI) scores were calculated. Mean IBDQ scores improved significantly over placebo by 2 weeks in budesonide 15 mg (155 ± 38; p = 0.006) and 9 mg groups (157 ± 33; p = 0.0002). Bowel, systemic, social, and emotional subscores were also significantly better (p < 0.002) at 2 and 8 weeks in the 9 mg group. Improved HRQOL scores correlated well with decreased CDAI (−0.8 < r < −0.4). Average per item change in IBDQ at remission was 1.17 to 1.48. Prior surgery (p < 0.005) or current smoker (p < 0.05) status predicted poorer initial HRQOL but not response. Budesonide CIR 9 or 15 mg/day rapidly and significantly improved HRQOL in active CD.

Decade-long use of continuous combined hormone replacement therapy is associated with better health-related quality of life in postmenopausal women, as measured by the generic 15D instrument

To examine quality of life after a decade of continuous combined hormone replacement therapy. The 15D, a generic health-related quality-of-life (HRQoL) instrument, was used to evaluate trends in HRQoL in women who used continuous combined hormone replacement therapy (ccHRT; Indivina, Orion Pharma, Finland) for up to nine years. These women had a mean age of 56 years of age at the start of therapy. Control data on HRQoL were obtained from age-matched women participating in Finnish population health surveys. Relative to controls, ccHRT was associated with significantly better HRQoL after six and nine years of treatment. Dose minimization at 8.5 years was not associated with a decline in HRQoL in the ensuing six months. One year after discontinuation of ccHRT there was evidence of a decline in HRQoL in women who discontinued ccHRT as planned, whereas HRQoL was maintained in women who had continued or resumed ccHRT during the one-year post-study follow-up. The benefits of ccHRT were apparent in multiple dimensions of the 15D, being largest and most robustly reproduced in the dimension 'discomfort and symptoms'. It is conjectured that the effectiveness of ccHRT in relieving symptoms of menopause may have contributed to the improved HRQoL scores registered in other dimensions, in addition to any direct effects of ccHRT on specific aspects of those other dimensions. These data indicate that up to 10 years of low-dose ccHRT has sustained value in the enhancement of HRQoL when used by women for whom relief of symptoms of menopause and control of bleeding are primary objectives of treatment.

Health-related quality of life in patients with glioblastoma: a randomised controlled trial

A randomised controlled trial of radiotherapy alone versus radiotherapy with concomitant and adjuvant temozolomide for patients with glioblastoma showed that survival was higher for patients assigned combination treatment compared with those assigned standard radiotherapy alone. This paper reports the health-related quality of life (HRQOL) of the patients in this trial. 573 patients with newly diagnosed glioblastoma were randomly allocated either radiotherapy alone or radiotherapy and temozolomide. The primary endpoint was survival, and HRQOL was a secondary endpoint. We assessed HRQOL at baseline and at every 3 months during treatment until progression using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (QLQ-C30) and the EORTC brain cancer module (EORTC BN-20). We calculated changes from baseline score for seven predefined HRQOL measures (fatigue, overall health, social function, emotional function, future uncertainty, insomnia, and communication deficit) and differences between groups for these measures at every time point. The significance of, and proportions of patients with, improved HRQOL scores--defined as a change of 10 points or more--were recorded. This trial is registered on the US National Cancer Institute website http://www.cancer.gov/search/NewClinicalTrials, NCT00006353. Baseline questionnaires were available for 490 (86%) patients. Baseline HRQOL scores did not differ between groups. At first follow-up, groups differed only in social functioning, favouring the radiotherapy-only group (mean score 79.0 [SD 3.2] for patients assigned radiotherapy vs 67.4 [2.7] for those assigned radiotherapy and temozolomide; difference between groups 11.6 points [95% CI 3.5-19.7], p=0.0052). Over subsequent assessments, HRQOL was much the same between treatment groups. Addition of temozolomide during and after radiotherapy for patients with newly diagnosed glioblastoma significantly improved survival without a negative effect on HRQOL.

Health-Related Quality of Life (HRQL) in Children with Severe, Chronic Immune Thrombocytopenia (cITP) Treated with Rituximab.

Background: A subset of children with cITP is at increased risk for severe bleeding and functional limitations. We evaluated the HRQL of children with cITP as part of a multicenter, open label Phase I/II clinical trial of four weekly doses of Rituximab, evaluated for response at 12 weeks. Responders had a ≥ 50,000/mm3 platelet count over weeks 9–12 without other supportive therapy.Methods: All participating parents were invited to complete the Child Health Ratings Inventories (CHRIs) at baseline and 12 wks. The CHRIs, a generic HRQL questionnaire, contains 20 items, forming four domains in the areas of physical, role, and emotional functioning, and school. Each item has a five-point Likert response scale. Domain scores range from 0–100, with higher scores connoting better functioning. Of the 36 study participants, 24 parents opted to participate in the HRQL evaluation; 22 of 24 (91%) completed both the baseline and 12-week assessments. The baseline clinical profile and 12-week Rituximab response rates of HRQL participants and non participants (n=12) were compared. Potential clinical covariates (e.g., duration of illness, worst bleeding score, platelet count, number of prior therapies) were examined in a univariate analysis (UVA) with baseline HRQL domain scores. Regression analyses (MVA) adjusting for age and gender were used to assess the effects of treatment response and clinical covariates on the mean change in scores between baseline and week 12.Results: While HRQL participants had more previous treatments and lower platelet counts than nonparticipants, their clinical profile was otherwise similar; Rituximab response rates did not differ. Mean HRQL domain scores (standard deviation) at baseline were as follows: physical-52.1 (36.2); role-78.6 (23.7); emotional-63.4 (18.3); school-64.1 (25.8). Lower platelet count and greater number of prior therapies were significantly associated with worse baseline HRQL scores on UVA. By week 12, 36% (8/22) responded to Rituximab. Clinically meaningful improvements in HRQL scores (≥ 0.5 standard deviation improvement) were observed in responders; no change was detected in non-responders. In MVA, responder status contributed the predominate effect on the HRQL change scores, with the greatest improvement noted in emotional functioning (p=.002). No other clinical variables emerged in this limited sample size.Conclusions: The pattern of parent-reported HRQL scores for these children with severe cITP mirrored scores from other severe, pediatric health conditions. Significant improvements in HRQL were observed among Rituximab responders over the 12-week period while non-responders had no change. Further overall characterization of HRQL in the cITP pediatric population is needed.

Epoetin Alfa Once Weekly Improves Anemia in HIV/Hepatitis C Virus-Coinfected Patients Treated With Interferon/Ribavirin: A Randomized Controlled Trial

Epoetin Alfa Once Weekly Improves Anemia in HIV/Hepatitis C Virus-Coinfected Patients Treated With Interferon/Ribavirin: A Randomized Controlled Trial

HIV-Related Neurological Syndromes Reduce Health-Related Quality of Life

Human immunodeficiency virus (HIV) infection frequently results in neurological complications but the impact of different neurological syndromes on patients' quality of life remains unknown. We investigated health-related quality of life (HRQoL) parameters among HIV/Acquired Immune Deficiency Syndrome (AIDS) patients with and without neurological disease, including 11 dimensions of HRQoL within the Medical Outcomes Short-form Health Survey-HIV. Comparisons of sociodemographic and systemic clinical variables did not differ between HIV/AIDS patients with (n=94) and without (n=75) neurological disease. However, patients with neurological diseases exhibited significantly lower HRQoL scores compared to matched controls, which was most evident among HIV/AIDS patients with cognitive impairment and sensory neuropathy. Prospective analysis revealed diminishing HRQoL scores prior to neurological diagnosis followed by a progressive and sustained improvement in HRQoL scores after intervention over a 96-week period. These studies indicate that while HIV-related neurological diseases are associated with reduced HRQoL scores, enhanced neurological care has a positive impact on HIV/AIDS patients' overall well-being.

Impact of fibromyalgia pain on health-related quality of life before and after treatment with tramadol/acetaminophen

To assess health-related quality of life (HRQOL) in patients with moderate-to-severe fibromyalgia pain compared with the general population, and to assess the relationship between pain severity and HRQOL before and after treatment with an analgesic. Data were obtained from a randomized, double-blind study of patients with moderate-to-severe fibromyalgia pain. Patients received either tramadol/acetaminophen or placebo 4 times/day as needed for 91 days. HRQOL was measured with the Short Form 36 Health Survey (SF-36) and the Fibromyalgia Impact Questionnaire (FIQ). Baseline HRQOL scores were compared with a national sample of noninstitutionalized adults and a sample of patients with impaired HRQOL due to congestive heart failure. Patients with fibromyalgia were divided into tertiles by change in pain severity, and SF-36 scores were compared across the tertiles. Mean changes in SF-36 and FIQ scores were compared between treatment groups. Patients with fibromyalgia scored lower than the US norm on all SF-36 scales (P < 0.0001) and lower than patients with congestive heart failure on most scales. More severe pain was associated with greater impairment of HRQOL compared with less severe pain (P < 0.0001). Patients in the highest tertile for improved pain severity had greater improvement in HRQOL scores than patients in the lower tertiles. Compared with patients who received placebo (n = 157), patients treated with tramadol/acetaminophen (n = 156) showed greater improvement on SF-36 physical functioning, role physical, bodily pain, and physical summary scales, as well as FIQ scales for ability to do job, pain, and stiffness (P < 0.01). Moderate-to-severe fibromyalgia pain significantly impairs HRQOL, and effective pain relief in these patients significantly increases HRQOL.

A Health-Related Quality-of-Life Comparison of Formoterol (Oxis®) Turbuhaler® plus Budesonide (Pulmicort®) Turbuhaler® with Budesonide Turbuhaler® Alone and Noncorticosteroid Treatment in Asthma: A Randomized Clinical Study in Russia

Background: In Russia, current therapy for the long-term management of asthma is mainly nonsteroidal. This situation provides the opportunity to evaluate new asthma treatments in a patient cohort with little previous exposure to inhaled corticosteroids. Objectives: To compare the effect of formoterol (Oxis^®) Turbuhaler^® plus budesonide (Pulmicort^®) Turbuhaler with budesonide Turbuhaler alone, on the health-related quality of life (HRQL) of patients with mild to moderate asthma. Methods: A double-blind, parallel-group, randomized, 12-week study compared formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone with an open control group of the investigator’s choice of noncorticosteroid therapy. Patients completed the Short Form 36 (SF-36) and the Asthma Quality of Life Questionnaire (AQLQ). Results: The improvement in HRQL scores for patients treated with noncorticosteroids was significantly less (p < 0.05) than those treated with formoterol plus budesonide and budesonide alone in all domains of the SF-36 and AQLQ with one marginal exception (budesonide versus investigator’s choice, SF-36, Mental Component Scale, p = 0.053). Improvements in HRQL scores of formoterol plus budesonide, compared with budesonide alone, although generally higher, were not significantly different. Formoterol plus budesonide was more effective in improving lung function and reducing both symptoms and the need for relief terbutaline inhalation. Conclusion: Formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone significantly improved the HRQL of patients with mild to moderate asthma compared with noncorticosteroid treatment.