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HRQoL Assessment (hrqol + assessment)
Selected AbstractsHealth-related quality of life assessment in randomised controlled trials in multiple myeloma: a critical review of methodology and impact on treatment recommendationsEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 4 2009Ann Kristin Kvam Abstract Objectives:, Patients with multiple myeloma (MM) often have pronounced symptoms and substantially reduced quality of life. The aims of treatment are to control disease, maximise quality of life and prolong survival. Hence, health-related quality of life (HRQOL) should be an important end-point in randomised controlled trials (RCTs) in addition to traditional endpoints. We wanted to evaluate whether trials reporting HRQOL outcomes have influenced clinical decision making and whether HRQOL was assessed robustly according to predefined criteria. Methods:, A systematic review identified RCTs in MM with HRQOL assessment as a study end-point. The methodological quality of these studies was assessed according to a checklist developed for evaluating HRQOL outcomes in clinical trials. The impact of the HRQOL results on clinical decision making was assessed, using published clinical guidelines as a reference. Results:, Fifteen publications presenting RCTs with HRQOL as a study end-point were identified. In 13 trials, the author stated that HRQOL results should influence clinical decision making. We found, however, that the HRQOL data only had a limited impact on published treatment guidelines for bisphosphonates, high-dose treatment, interferon, erythropoiesis-stimulating agents and novel agents. Conclusion:, The present review indicates that the there are still few RCTs in MM including HRQOL as a study end-point. Systematic incorporation of HRQOL measures into clinical trials allows for a comparison of treatment arms that includes the patients' perspective. Before the full impact on clinical decisions can be realised, the quality and methodology of collecting HRQOL data must be further improved and the results rendered more comprehensible to clinicians. [source] Prospective assessment of the effect on quality of life of anti-tumour necrosis factor therapy for perineal Crohn's fistulasALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2009S. C. NG Summary Background, Anti-tumour necrosis factor (TNF) therapy effectively treats Crohn's perineal fistulas (CPF); the effect on health-related quality of life (HRQoL) remains unknown. Aims, To evaluate the effect of anti-TNF therapy on the HRQoL of patients with CPF in daily clinical practice. Methods, Prospective evaluation of clinical and magnetic resonance imaging (MRI) responses, disease activity (Perianal Disease Activity Index , PDAI), and HRQoL assessment [Inflammatory Bowel Disease Questionnaire (IBDQ)] in patients receiving anti-TNF therapy for CPF treated up to 12 months. Results, In all, 26 patients with CPF were treated (mean age 39 years; 19 infliximab, 7 adalimumab). At baseline, 85% patients had impaired IBDQ scores (mean 137; ,normal' >170). At 12 months, mean increases in IBDQ score for infliximab and adalimumab treated patients were 40 and 41 points respectively (P < 0.05). There were significant improvements in all IBDQ subscores (bowel, emotional, systemic, social) at 12 months (all P , 0.003). Fourteen patients (74%) on infliximab and six on adalimumab (86%) achieved IBDQ score ,170. Mean increase in IBDQ score was 50, 34 and 16 points in patients with clinical fistula closure (P < 0.001), clinical response (P = 0.002) and no response (n = 1) respectively. IBDQ score increased for patients with MRI healing (P < 0.001) and MRI improvement (P = 0.016), but not for those with no MRI change (n = 2). IBDQ correlated significantly with PDAI at baseline and at 12 months. Conclusion, Anti-TNF therapy improves HRQoL in patients with CPF at 12 months and this improvement is most pronounced in patients with clinical and MRI healing. [source] Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA2LEN taskforce position paperALLERGY, Issue 8 2010F. Braido To cite this article: Braido F, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A, Fokkens W, Gerth van Wijk R, La Grutta S, Lombardi C, Maurer M, Pinto AM, Ridolo E, Senna GE, Terreehorst I, Todo Bom A, Bousquet J, Zuberbier T, Baiardini I. Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA2LEN taskforce position paper. Allergy 2010; 65: 959,968. Abstract The GA2LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patient-related factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaining increasing importance, and it must be performed with a rigorous methodological procedure and using validated tools. This approach enables to better understand patient-related factors influencing clinical trials and real-life management outcomes, identify patients subgroups that can benefit from specific treatment and management plan and tailor treatment to address PROs (not only physician-defined targets) to improve asthma and rhinitis management. [source] Insurance and quality of life in men with prostate cancer: data from the Cancer of the Prostate Strategic Urological Research EndeavorBJU INTERNATIONAL, Issue 6 2008Natalia Sadetsky OBJECTIVE To evaluate the effect of medical insurance coverage on health-related quality of life (HRQoL) outcomes in men newly diagnosed with prostate cancer, as insurance status has been shown to be related to clinical presentation, and types of treatments received for localized prostate cancer, but the relationship of insurance and QoL has not been explored sufficiently. PATIENTS AND METHODS Data from the Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE), a national longitudinal database registry of men with prostate cancer, were used for this study. Men who were newly diagnosed at entry to CaPSURE and completed one questionnaire before treatment, and one or more afterwards, were included. Insurance groups specific to age distribution of the study population were assessed, i.e. Medicare, preferred provider organizations (PPOs), health maintenance organizations (HMOs), fee for service (FFS), and the Veterans Administration (VA) for the younger group, and Medicare only, Medicare plus supplement (+S), and HMO/PPO for the older group. Associations between patients' clinical and sociodemographic characteristics and insurance status were evaluated by chi-square and analysis of variance. Relationships between insurance status and HRQoL outcomes over time were evaluated by multivariate mixed model. RESULTS Of 2258 men who met the study criteria, 1259 were younger and 999 were older than 65 years. More than half of the younger patients belonged to an HMO or PPO (42.2% and 32.5%, respectively), with the remainder distributed between Medicare, FFS and VA. In the older group most men belonged to Medicare only and the Medicare +S groups (22.4% and 58.8%, respectively). There was greater variation in clinical risk categories at presentation by insurance groups in the younger group. In the multivariate analysis, insurance status was significantly associated with changes in most HRQoL outcomes over time in the younger group, while in the older patients the effect of insurance diminished. Men in the VA and Medicare systems had lower scores at baseline and a steeper decline in Physical Function, Role Physical, Role Emotional, Social Function, Bodily Pain, Vitality, and General Health domains over time, controlling for type of initial treatment received, timing of HRQoL assessment, number of comorbidities, clinical risk at presentation, and income. CONCLUSION Insurance was independently related to changes in a wide range of HRQoL outcomes in men aged <65 years treated for prostate cancer. With the latest advances in early diagnosis and treatment of prostate cancer, clinicians and researchers should be aware of the specific groups of patients who are more vulnerable to the adverse effects of treatment and subsequent decline in functioning. The present findings could provide important tools for understanding the process of recovery after treatment for prostate cancer, and identifying needs for specific services. [source] Quality of life and use of red cell transfusion in patients with myelodysplastic syndromes.AMERICAN JOURNAL OF HEMATOLOGY, Issue 10 2009A systematic review The main treatment for many patients with Myelodysplastic Syndromes (MDS) remains red cell transfusion to attenuate the symptoms of chronic anemia. Fatigue can reduce a patient's health related quality of life (HRQoL), but there is little understanding of the optimal use of transfusions to improve this. A systematic review was performed to identify and appraise publications reporting the use of HRQoL instruments in patients with MDS. A total of 17 separate studies were identified that used 14 HRQoL instruments, but only one MDS disease specific HRQoL instrument (QOL-E) was reported. Two well established HRQoL instruments were most often used in MDS research (variants of the Functional Assessment of Cancer Therapy (FACT) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30)). Several common problems were identified in the published literature including a lack of power calculations to detect clinically relevant changes, small sample sizes and significant attrition rates for completion of HRQoL assessments, all of which limit the strength of any conclusions. There is no consensus on the optimal transfusion regimen to improve HRQoL in transfusion-dependent MDS. Future research into HRQoL within MDS is a pressing requirement. Studies should focus on the domains that are of most clinical importance to the patient as well as traditional quantitative changes of hemoglobin concentration. Am. J. Hematol., 2009. © 2009 Wiley-Liss, Inc. [source] | ||||||||||