title: Mapping SF-36 onto the EQ-5D index: how reliable is the relationship? The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study Weekly administration of epoetin alfa improves cognition and quality of life in patients with breast cancer receiving chemotherapy. Evaluation of index and profile measures of health status in a randomized controlled trial. Comparison of the Medical Outcomes Study 36-Item Short Form Health Survey, EuroQol, and disease specific measures. Impact of transanal endoscopic microsurgery on functional outcome and quality of life Evaluating the ability to detect change of health‐related quality of life in children with Hodgkin disease Randomized trial of health-related quality of life after open and laparoscopic surgery for colon cancer Mapping the QLQ-C30 quality of life cancer questionnaire to EQ-5D patient preferences EuroQol and survival prediction in terminal cancer patients: a multicenter prospective study in hospice-palliative care units The psychological impact of human papillomavirus testing in women with borderline or mildly dyskaryotic cervical smear test results: 6-month follow-up Health-related quality of life during post-induction chemotherapy in children with acute lymphoblastic leukemia in remission. Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab Nurse-led follow-up of patients after oesophageal or gastric cardia cancer surgery: a randomised trial A Randomized Controlled Clinical Trial of Palliative Therapies for Patients With Inoperable Esophageal Cancer Quality of life during maintenance therapy with the anti-CD20 antibody rituximab in patients with B cell non-Hodgkin’s lymphoma: results of a prospective randomized controlled trial Measuring quality of life: impact of chemotherapy for advanced colorectal cancer. Experience from two recent large phase III trials. Evaluating healing for cancer in a community setting from the perspective of clients and healers: a pilot study. The cost-effectiveness of hearing-aid fitting in the Netherlands. A prospective randomized study of megestrol acetate and ibuprofen in gastrointestinal cancer patients with weight loss A prospective study of the cost-utility of the multichannel cochlear implant. Cancer-related anorexia/cachexia syndrome and oxidative stress: an innovative approach beyond current treatment. Counselling of hearing aid users is highly cost-effective Health-related quality of life at age 10 years in very low-birth-weight children with and without threshold retinopathy of prematurity. Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy. Assessment of patient preferences among men with prostate cancer. Lower visual acuity predicts worse utility values among patients with type 2 diabetes Cost analysis and quality of life assessment comparing patients undergoing autologous peripheral blood stem cell transplantation or autologous bone marrow transplantation for refractory or relapsed non-Hodgkin's lymphoma or Hodgkin's disease. a prospective randomised trial. Societal effects of hearing aid fitting among the moderately hearing impaired: Efectos sociales de la adaptación de auxiliares auditivos en pacientes con impedimentos auditivos moderados Health Status in Survivors of Cancer in Childhood and Adolescence Quality of life after palliative treatment for oesophageal carcinoma -- a prospective comparison between stent placement and single dose brachytherapy. Improvements in patient-reported outcomes in moderate-to-severe psoriasis patients receiving continuous or paused etanercept treatment over 54 weeks: the CRYSTEL study. Health related quality of life in patients with multiple myeloma undergoing a double transplantation. Measuring health-related quality of life in patients with venous leg ulcers Generic and specific measurement of health-related quality of life in a clinical trial of respiratory rehabilitation. US Valuation of the EQ-5D Health States: Development and Testing of the D1 Valuation Model A longitudinal prospective study of health-related quality of life in breast cancer patients following high-dose chemotherapy with autologous blood stem cell transplantation The effect of cytomegalovirus retinitis on the quality of life of patients with AIDS in the era of highly active antiretroviral therapy. Adalimumab treatment is associated with improvement in health‐related quality of life in psoriasis: Patient‐reported outcomes from a Phase II randomized controlled trial Mapping the Modified Rankin Scale (mRS) Measurement into the Generic EuroQol (EQ-5D) Health Outcome The bone-anchored hearing aid: quality-of-life assessment. An empirical comparison of EQ-5D and SF-6D in liver transplant patients. Nurses provide valuable proxy assessment of the health‐related quality of life of children with Hodgkin disease Psychometric evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness. Effect of hearing aids on hearing disability and quality of life in the elderly Is there overutilisation of cataract surgery in England? Evaluation of healing by gentle touch in 35 clients with cancer. Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study. Effectiveness of mirtazapine for nausea and insomnia in cancer patients with depression. Multiattribute and Single‐Attribute Utility Functions for the Health Utilities Index Mark 3 System Changes in Quality of Life and the Cost-Utility Associated with Cochlear Implantation in Patients with Large Vestibular Aqueduct Syndrome Measurement of Health-Related Quality of Life in the Early Follow-Up of Colon and Rectal Cancer Estimating a preference-based single index from the Overactive Bladder Questionnaire. The impact of a two‐compound product containing calcipotriol and betamethasone dipropionate (Daivobet®/ Dovobet®) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial Mapping the cancer-specific EORTC QLQ-C30 to the preference-based EQ-5D, SF-6D, and 15D instruments.
abstract: Background Mapping from health status measures onto generic preference-based measures is becoming a common solution when health state utility values are not directly available for economic evaluation . However the accuracy and reliability of the models employed is largely untested , and there is little evidence of their suitability in patient data sets . This paper examines whether mapping approaches are reliable and accurate in terms of their predictions for a large and varied UK patient data set . Methods SF-36 dimension scores are mapped onto the EQ-5D index using a number of different model specifications . The predicted EQ-5D scores for subsets of the sample are compared across inpatient and outpatient setting s and medical conditions . This paper compares the results to those obtained from existing mapping functions . Results The model including SF-36 dimensions , squared and interaction terms estimated using r and om effects GLS has the most accurate predictions of all models estimated here and existing mapping functions as indicated by MAE ( 0.127 ) and MSE ( 0.030 ) . Mean absolute error in predictions by EQ-5D utility range increases with severity for our models ( 0.085 to 0.34 ) and for existing mapping functions ( 0.123 to 0.272 ) . Conclusion Our results suggest that models mapping the SF-36 onto the EQ-5D have similar predictions across inpatient and outpatient setting and medical conditions . However , the models overpredict for more severe EQ-5D states ; this problem is also present in the existing mapping functions Background Patient-reported outcome ( PROs ) measures are being used more frequently in investigational studies of treatments for moderate to severe plaque psoriasis . The objective of this study was to examine the relationships among the Dermatology Life Quality Index ( DLQI ) , the Short Form 36 ( SF-36 ) , and the EuroQOL 5D ( EQ-5D ) and to assess their validity , responsiveness , and estimates of minimum important differences . Methods A Phase II , r and omized , double-blind , parallel group , placebo-controlled , multi-center clinical trial assessed the clinical efficacy and safety of two doses of subcutaneously administered adalimumab vs. placebo for 12 weeks in the treatment of 147 patients with moderate to severe plaque psoriasis . This study provided the opportunity to evaluate the validity and responsiveness to change in clinical status of PROs instruments . Patients completed the DLQI , SF-36 , and EQ-5D question naires at baseline and at 12 weeks . Blinded investigators assessed the Psoriasis Area and Severity Index ( PASI ) scores and the Physician 's Global Assessment ( PGA ) scores of enrolled patients . The responsiveness of the measures to changes in the clinical endpoints from baseline to Week 12 was assessed . Estimates of minimum important differences ( MID ) were derived . All analyses were performed with blinded data ; findings and conclusions were not biased based on treatment condition . Results The dermatology-specific DLQI was highly correlated to clinical endpoints at baseline and at Week 12 , and was the most responsive PRO to changes in endpoints . Compared with the SF-36 , the EQ-5D index score and VAS scores were generally more highly correlated with clinical endpoints , but displayed about the same degree of responsiveness . The most responsive SF-36 scales were the Bodily Pain and Social Functioning scales . Estimates of the MID for the DLQI ranged from 2.3–5.7 and for the SF-36 Physical Component Summary ( PCS ) score ranged from 2.5–3.9 . Conclusion This study provides support for the continued use of the DLQI and SF-36 PCS in the assessment of treatments for psoriasis . On the basis of the results from this trial , the EQ-5D should be considered as a general PRO measure in future clinical trials of patients with moderate to severe plaque psoriasis Patients with breast cancer treated with adjuvant chemotherapy  experience not only fatigue and menopausal symptoms but also documented cognitive dysfunction and reduced capacity to carry out activities of daily living . The role of epoetin alfa in improving cognition and functional capacity was assessed in a large r and omized trial through patient self-reported outcomes . Patients with breast cancer ( N = 354 , adjuvant and metastatic ) undergoing chemotherapy  were r and omized in a 1:1 ratio to receive epoetin alfa ( 40,000 IU once weekly ) or the st and ard of care ( SOC ) . Change in patient-reported Health Utilities Index Mark 3 ( HUI3 ) from baseline to week 12 was compared between the epoetin alfa and SOC groups . In addition , correlations between the disease-nonspecific HUI3 utility scale and the cancer-specific quality of life instrument Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) and Fatigue subscales were assessed . Epoetin alfa treatment significantly improved HUI3 scores compared with patients receiving SOC ( P = 0.036 ) . Three subscales within HUI3 were also significantly better for epoetin alfa-treated patients ( emotion , P = 0.048 ; ambulation , P = 0.048 ; and cognition , P = 0.02 ) . Moreover , a strong correlation ( P = 0.0001 ) exists between the disease-nonspecific utility scale HUI3 and the disease-specific FACT-An and FACT-Fatigue scales in terms of overall scores and score changes . The findings of the study demonstrate for the first time in patients with breast cancer that epoetin alfa significantly enhances functional well-being , which translates into significantly better utility scores . In addition , epoetin alfa also significantly improved cognitive function of women undergoing chemotherapy , and this could have an important impact on their lives from a societal perspective OBJECTIVES The authors compare two generic measures of health status with disease-specific measures in a r and omized controlled trial of  transurethral resection of the prostate with laser vaporization prostatectomy for benign prostatic hypertrophy . METHODS Patients entered into the trial completed the following question naires prior to treatment and at follow-up at 3 months and 1 year . The Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) is a generic measure that produces an eight-dimension profile as well as two summary measures of health status ( the physical component score and the mental component score ) . The EuroQol provides two single index measures of health status ; one intended to convey the utility ( or lack of ) that an individual derives from his or her own health state compared with alternative states and a second simple visual analog scale " thermometer " of health status . The American Urological Association symptom score and the Bothersome index are disease-specific indices of health status for use specifically with benign prostatic hypertrophy patients . RESULTS The EuroQol indicates no statistically significant improvements with time for either arm of the trial . The SF-36 physical and general health perceptions domains indicates statistically significant improvements for the transurethral resection of the prostate arm alone at 3 months and 1 year , as do the physical summary score at the 3-month follow-up visit . The effect sizes of these improvements , however , are small , using st and ard criteria . In contrast , statistically significant differences are found with time for both  transurethral resection of the prostate and laser prostatectomy  on both disease-specific measures , which also indicate statistically significant superior outcome for the transurethral resection of the prostate arm compared with the laser arm . CONCLUSIONS The results indicate that the disease-specific measures are more sensitive to change than the generic measures of outcome . Possible explanations for this are discussed Abstract Introduction Transanal endoscopic microsurgery ( TEM ) is a minimal invasive technique for local excision of rectal tumours . The procedure is performed via a rectoscope with a diametre of 4 cm . The aim of this prospect i ve study was to assess both functional outcome and quality of life after TEM . Patients and methods Between 2004 and 2006 , 47 patients were studied prior to and at least 6 months after TEM .  Demographics , operative details and post-operative complications were recorded . Functional outcome was determined using the Faecal Incontinence Severity Index ( FISI ) . Quality of life was measured using the EuroQol EQ-5D question naire and the Faecal Incontinence Quality of Life ( FIQL ) score . Results Six months after surgery , median FISI score was found to be decreased ( p < 0.01 ) , depicting an improvement in faecal continence . This improvement was most significant in tumours within 7 cm from the dentate line ( p = 0.01 ) . From the patients ’ perspective , post-operative quality of life was found to be higher ( p < 0.02 ) . A significant improvement was observed in two of the four FIQLS domains ( embarrassment , p = 0.03 ; lifestyle , p = 0.05 ) . The domains of lifestyle , coping and behaviour and embarrassment were correlated with the FISI ( all p < 0.05 ) . Conclusion This study indicates TEM has no deteriorating effect on faecal continence . Moreover , once the tumour has been excised using TEM , quality of life is improved We evaluated 4 different health‐related quality of life ( HRQL ) measures prospect ively to determine their ability to detect change over time : the Health Utilities Index Mark 2 and Mark 3 , the Pediatric Quality of Life Inventory ( PedsQL ) 4.0 Generic Core and Cancer Module , the EuroQol EQ‐5D visual analogue scale ( EuroQol ) , and the Lansky Play‐Performance Scale Background R and omized controlled trials ( RCTs ) have reported improved or unchanged three-year survival following  laparoscopic colon resection ( LCR ) for colon cancer compared with that following open resection ( OCR ) . The aim of this study was to determine health-related quality of life ( HRQL ) in patients r and omized to laparoscopic or open resection for colon cancer . Methods In total , 285 patients ( 130 LCR , 155 OCR ) from seven Swedish centers were included .  HRQL was assessed preoperatively and at 2 , 4 , and 12 weeks postoperatively with the EQ-5D and EORTC QLQ-C30 instruments . Results The LCR patients did significantly better on the social function component of the EORTC QLQ-C30 at two and four weeks and on the role function component at two weeks . Conclusion Laparoscopic resection for colon cancer improved quality of life during the first postoperative month Background Although cancer-specific Health-Related Quality of Life ( HRQOL ) are commonly included in r and omized clinical trials or other prospect i ve non-r and omized clinical studies , it is rare that preference-based instruments are used that allow the calculation of a utility weight suitable for estimating quality -adjusted life-years gained . Objective To develop a mapping algorithm to transform the EORTC QLQ-C30 question naire responses into EQ-5D derived utilities . Study design Retrospective data analysis of a multicentre , multicountry prospect i ve clinical trial in breast cancer patients . Methods Regression analysis of individual pairs of EQ-5D and QLQ-C30 scores . Results A model that explained 80 % of the variance was developed to estimate EQ-5D Utilities from QLQ-C30 scores at individual level . From this reliable group level means and deviations can be derived . Conclusions Mapping from QLQ-C30 scores to EQ-5D-derived utilities when only QLQ-C30 data are available has been shown to be possible with good accuracy . Validation of the proposed algorithm in other external clinical data sets should be encouraged Goals of workAlthough the EuroQol ( EQ-5D ) is widely used for economic evaluation , it remains unclear whether it can be combined with medical data to predict survival in patients with terminal cancer . Patients and methods We carried out this prospect i ve study on 142 terminal cancer patients in four hospice-palliative care units . Association was sought between survival time and a range of variables such as cancer site , performance , previous treatment , age , sex , pain , and EuroQol . The EQ-5D was transformed into the corresponding EQ-5D utility . For univariate analysis , we estimated differences in survival with the Gehan generalized Wilcoxon test . For those variables that were significant , we performed multivariate analysis using the Cox proportional hazard model . Main results Univariate analysis showed that sex , age , performance , previous use of chemotherapy , and the EQ-5D utility provided statistically significant prognostic survival information . The median survival time was 13.0 days for the group with an EQ-5D utility score lower than −0.5 and 21.0 days for the group with an EQ-5D utility score above −0.5 . In multivariate analysis with the Cox proportional hazard model , an EQ-5D utility score ≤0.5 ( RR 1.57 , 95 % confidence interval 1.06–2.33 ) was an independent negative predictor of survival . Conclusions The EQ-5D quality -of-life assessment tool might be useful for predicting survival time for terminal cancer patients State anxiety ( S-STAI-6 ) , distress ( GHQ-12 ) , concern and quality of life ( EuroQoL-EQ-5D ) 6 months after human papillomavirus ( HPV ) testing in women with borderline or mildly dyskaryotic smear test results were assessed based on a prospect i ve question naire study , with 6-month follow-up after the smear test result . Two centres participated in an English pilot study of HPV testing . Participants included two groups of women receiving abnormal smear test results : ( tested for HPV and found to be ( a ) HPV positive ( n=369 ) or ( b ) HPV negative ( n=252 ) ) and two groups not tested for HPV ( those receiving ( c ) abnormal smear test results ( n=102 ) or ( d ) normal smear test results ( n=288 ) ) . There were no differences in anxiety , distress or health-related quality of life between the four study groups at 6 months . Levels of concern about the smear test result remained elevated in all groups receiving an abnormal smear test result , and were highest in the group untested for HPV . Predictors of concern across all groups receiving an abnormal smear test were perceived risk of developing cancer , being HPV positive or untested for HPV , sexual health worries and the smear being a woman 's first smear test . The raised anxiety and distress observed in women immediately after being informed of an abnormal smear test result and that they are HPV positive was no longer evident at 6 months . Concern about the smear test result was however still raised in these women and those who tested negative for HPV , and particularly among those who did not undergo HPV testing Using a multi-attribute approach , we and others have reported on the comprehensive health status of survivors of cancer in childhood , after completion of therapy . However , there is a dearth of information about health status and associated health-related quality of life ( HRQL ) in children and adults with cancer , during the treatment process ; a deficit which this study was intended to redress . All children ( n=18 ) receiving ' maintenance ' chemotherapy for acute lymphoblastic leukemia ( ALL ) at a single institution were assessed prospect ively through a single cycle of therapy . Patients , family members and health care professionals used global ratings , the health utilities index mark 2 ( HUI2 ) and mark 3 ( HUI3 ) classification systems , and detailed descriptions of temporary states of health , to provide independent assessment s of health status at weekly intervals . Utility scores were derived for each comprehensive health state and for single attribute levels of the HUI2 system , and for the temporary health state descriptions . The classification of the subjects into the most appropriate temporary health states was challenging even for older children and some of the parents . The HUI instruments were used much more easily and produced highly comparable information . The most frequently affected attributes were pain , emotion and mobility/ambulation ; in that order . The global ( p=0.005 ) and specific morbidity burdens were , as predicted , greatest in the middle of the cycle of chemotherapy , reflecting the toxicity of steroid use . HUI2 global utility scores demonstrated moderate responsiveness with an intra-class correlation coefficient of 0.43 . Cyclical administration of therapy , in particular corticosteroids , produces important changes in health status and HRQL in children with ALL . The HUI are valid and responsive systems for quantifying the burden of morbidity during the treatment of cancer in childhood . These are sensitive tools which can be used in a wide array of other circumstances to quantify changes in health status In a r and omised phase 3 trial , panitumumab significantly improved progression-free survival ( PFS ) in patients with refractory metastatic colorectal cancer ( mCRC ) . This analysis characterises the association of PFS with CRC symptoms , health-related quality of life ( HRQoL ) , and overall survival ( OS ) . CRC symptoms ( NCCN/FACT CRC symptom index , FCSI ) and  HRQoL  ( EQ-5D ) were assessed for 207 panitumumab patients and 184 best supportive care ( BSC ) patients who had at least one post-baseline patient-reported outcome ( PRO ) assessment . Patients alive at week 8 were included in the PRO and OS analyses and categorised by their week 8 progression status as follows : no progressive disease ( no PD ; best response of at least stable disease ) vs progressive disease ( PD ) . St and ard imputation methods were used to assign missing values . Significantly more patients were progression free at weeks 8–24 with panitumumab vs BSC . After excluding responders , a significant difference in PFS remained favouring panitumumab ( HR=0.63 , 95 % CI=0.52–0.77 ; P<0.0001 ) . At week 8 , lack of disease progression was associated with significantly and clinical ly meaningful lower CRC symptomatology for both treatment groups and higher HRQoL  for panitumumab patients only . Overall survival favoured no PD patients vs PD patients alive at week 8 . Lack of disease progression was associated with better symptom control , HRQoL , and OS Between January 2004 and February 2006 , 109 patients after intentionally curative surgery for oesophageal or gastric cardia cancer were r and omised to st and ard follow-up of surgeons at the outpatient clinic  ( st and ard follow-up ; n=55 ) or by regular home visits of a specialist nurse ( nurse-led follow-up ; n=54 ) . Longitudinal data on generic ( EuroQuol-5D , European Organization for Research and Treatment of Cancer ( EORTC ) QLQ-C30 ) and disease-specific quality of life ( EORTC QLQ-OES18 ) , patient satisfaction and costs were collected at baseline and at 6 weeks and 4 , 7 and 13 months afterwards . We found largely similar quality -of-life scores in the two follow-up groups over time . At 4 and 7 months , slightly more improvement on the EQ-VAS was noted in the nurse-led compared with the st and ard follow-up group ( P=0.13 and 0.12 , respectively ) . Small differences were also found in patient satisfaction between the two groups ( P=0.14 ) , with spouses being more satisfied with nurse-led follow-up ( P=0.03 ) . No differences were found in most medical outcomes . However , body weight of patients of the st and ard follow-up group deteriorated slightly ( P=0.04 ) , whereas body weight of patients of the nurse-led follow-up group remained stable . Medical costs were lower in the nurse-led follow-up group ( [ euro ] 2600 vs [ euro ] 3800 ) , however , due to the large variation between patients , this was not statistically significant ( P=0.11 ) . A cost effectiveness acceptability curve showed that the probability of being cost effective for costs per one point gain in general quality -of-life exceeded 90 and 75 % after 4 and 13 months of follow-up , respectively . Nurse-led follow-up at home does not adversely affect quality of life or satisfaction of patients compared with st and ard follow-up by clinicians at the outpatient clinic . This type of care is very likely to be more cost effective than physician-led follow-up OBJECTIVES : A dramatic rise in incidence , an aging population , and expensive palliative treatments have led to an escalating burden on clinicians managing inoperable esophageal cancer with only limited evidence of effectiveness . This study compares the clinical effectiveness and cost-effectiveness of self-exp and ing metal stents ( SEMSs ) with other palliative therapies to aid clinicians in making an evidence -based treatment choice . METHODS : We conducted a prospect i ve , multicenter , r and omized , controlled , clinical trial with 215 patients followed until death or study closure . The primary outcome measures were dysphagia , quality of life ( QL ) 6 weeks following treatment , and total cost of treatment . Secondary outcome measures included treatment-associated morbidity , mortality , survival , and cost-effectiveness . An intention-to-treat analysis was carried out . RESULTS : There was a significant difference in mean dysphagia grade between treatment arms 6 weeks following treatment ( P=0.046 ) , with worse swallowing reported by rigid stent – treated patients ( mean dysphagia score difference=−0.49 ; 95 % confidence interval ( CI ) −0.10 to −0.89 , P=0.014 ) . Global QL scores were lower at both 1 and 6 weeks following treatment for patients treated by SEMSs ( mean difference QL index week 1=−0.66 ; 95 % CI : −0.02 to −1.30 , P=0.04 ; mean difference QL index week 6=−1.01 ; 95 % CI −0.30 to −1.72 , P=0.006 ) . These findings were associated with higher post-procedure pain scores in the SEMS patient group ( mean difference of the European Organisation for Research and Treatment of Cancer QLQ C-30 pain symptom score at week 1=11.13 ; 95 % CI : 2.89–19.4 ; P=0.01 ) . Although mean EQ-5D QL values differed between the treatments ( P<0.001 ) , this difference dissipated following generation of quality -adjusted life year values . Total costs varied between treatment arms but these findings canceled out when SEMSs were compared with non-SEMS therapies ( 95 % CI −845.15–1,332.62 ) . These results were robust to sensitivity analysis . There were no differences in the in-hospital mortality or early complication rates , but late complications were more frequent after rigid stenting ( risk ratio=2.47 ; 95 % CI 1.88–3.04 ) . There was a survival advantage for non-stent-treated patients ( log-rank statistic=4.21 , P=0.04 ) . CONCLUSIONS : The treatment choice for patients with inoperable esophageal cancer should be between a SEMS or a non-stent treatment after consideration has been given to both patient and tumor characteristics and clinician and patient preferences The introduction of rituximab into the primary treatment of malignant lymphomas of the B cell lineage has had a major impact on the management of these diseases . In addition , prolonged exposure to rituximab as maintenance therapy has been beneficial in patients with follicular lymphoma and mantle cell lymphoma . For the individual patient , the effect of any prolonged antitumor therapy on the quality of life ( QoL ) is a very important question . However , so far , the question whether rituximab maintenance therapy may impair QoL in patients with non-Hodgkin ’s lymphoma remains unanswered . To investigate this subject , we have performed a prospect i ve r and omized trial of rituximab maintenance therapy ( 8 cycles rituximab 375 mg/m2 every 3 months ) versus observation in patients with CD20+B cell non-Hodgkin ’s lymphoma in our institution . Between July 2002 and December 2005 , 122 patients were included into the trial .  QoL was assessed with the st and ardized question naires EORTC-QLQ-C30 , EuroQol-5D , and EuroQol-5D ( VAS ) in 91 patients . After statistical analysis with the exact Wilcoxon rank sum test , we found no significant differences of the QoL between the rituximab treatment group and the observation group . We conclude that rituximab maintenance therapy seems to be safe and does not impair quality of life in this patient population When assessing the value of a particular treatment , it is important to consider the impact it may have on the quality of life of those being treated . This is particularly so for cancer patients , whose life expectancy may be short . Patients with advanced colorectal cancer who participated in two international comparative studies of raltitrexed ( ' Tomudex ' ) vs st and ard 5-fluorouracil ( 5-FU ) plus leucovorin ( LV ) completed previously vali date d quality -of-life question naires ( EORTC question naire , EuroQol and Rotterdam Symptom Check List ) at various times during the studies . Early statistically significant advantages of raltitrexed vs 5-FU plus LV on quality of life were observed at week 2 in five of eight of the EuroQol and three of four of the Rotterdam Symptom Check List dimensions . Such advantages were not observed using the EORTC question naire , which was not completed until week 12 . The necessary dose delays and different dose schedules made it difficult in these studies to compare the impact on quality of life of the two treatments . It may be that performance status , effect on disease-related symptoms and the incidence of toxicity are the most important indications of a patient 's quality of life The real-life practice of ' healing ' for cancer in the community as perceived by clients and healers was investigated in a multi- method pilot study . Fifteen clients received six weekly healing sessions .  Pre- and post-changes in perception towards well-being and client experience were assessed by EuroQol ( EQ-5D ) , measure yourself concerns and well-being ( MYCaW ) and a client satisfaction tool . Qualitative methods , including focus groups , explored the perceived effects of healing in more depth and the participants ' experience of taking part in research . The study was not design ed to test the effect of healing on disease . Quantitative data showed perceived significant improvements in ' concerns/problems ' for which clients wanted help ( p<0.01 ) , well-being ( p<0.01 ) and anxiety/depression ( p<0.05 ) over the course of healing . Significant effects were not seen in all areas of quality of life . Qualitative analysis showed clients mainly sought help for psychological and emotional concerns and reported only beneficial effects of healing . Clients attributed many of the quantitative improvements to healing itself . Despite some concerns , healers and clients engaged fully with the research process , and were enthusiastic about the importance of research into healing . Our study suggests that , while there are some confounding issues and study limitations to address , clients and healers perceive healing to have a range of benefits , particularly in terms of coping with cancer , and regard it as a useful approach that can be applied in a community setting alongside conventional medicine OBJECTIVE To determine the cost-effectiveness of hearing-aid fitting . DESIGN Cost-effectiveness analysis using a Markov model based on aggregate data and results from a prospect i ve intervention study . SETTING The cost-effectiveness study was based in the general community . The prospect i ve study was hospital based , as 85 % of the first-time hearing-aid users attend a hospital in the process of  hearing-aid fitting . PATIENTS The prospect i ve intervention study included adult first-time hearing-aid users with no contraindications for hearing-aid use . INTERVENTION The usual process of hearing-aid fitting in the Netherl and s. MAIN OUTCOME MEASURE Costs per quality -adjusted life-year ( QALY ) . The QALYs were based on EuroQol scores . We included direct and indirect costs in the analysis . RESULTS The mean improvement on the EuroQol measure was 0.03 ( 95 % confidence interval [ CI ] , -0.03 to 0.08 ) , and on the hearing-specific visual analog scale , 0.27 ( 95 % CI , 0.22 - 0.31 ) . The base-case outcome based on the EuroQol was 15 807/QALY ( US dollars 17 072/QALY ) ( CI , -24 239/QALY to 3718/QALY ) . CONCLUSIONS On the basis of this base-case estimate , fitting of hearing aids is considered a cost-effective health care intervention . The CI indicates that the result is not unambiguously positive , probably because the EuroQol lacked sensitivity for the evaluation of hearing-aid fitting . Until now , no study has found an effect of hearing-aid fitting on generic quality of life . Therefore , measures are needed that are suitable for the evaluation of the effects of interventions for sensory disabilities , such as the fitting of hearing aids , on generic quality of life Summary The use of megestrol acetate in the treatment of weight loss in gastrointestinal cancer patients has been disappointing . The aim of the present study was to compare the combination of megestrol acetate and placebo with megestrol acetate and ibuprofen in the treatment of weight loss in such patients . At baseline , 4–6 weeks and 12 weeks , patients underwent measurements of anthropometry , concentrations of albumin and C-reactive protein and assessment of appetite , performance status and quality of life using EuroQol-EQ-5D and EORTC QLQ-C30 .  Thirty-eight and 35 patients ( median weight loss 18 % ) were r and omized to megestrol acetate/placebo or megestrol acetate/ibuprofen  , respectively , for 12 weeks . Forty-six ( 63 % ) of patients failed to complete the 12-week assessment . Of those evaluable at 12 weeks , there was a decrease in weight ( median 2.8 kg ) in the megestrol acetate/placebo group compared with an increase ( median 2.3 kg ) in the megestrol acetate/ibuprofen group ( P < 0.001 ) . There was also an improvement in the EuroQol-EQ-5D quality of life scores of the latter group ( P < 0.05 ) . The combination of megestrol acetate/ibuprofen appeared to reverse weight loss and appeared to improve quality of life in patients with advanced gastrointestinal cancer . Further trials of this novel regimen in weight-losing patients with hormone-insensitive cancers are warranted CONTEXT Prior clinical studies have indicated that cochlear implantation provides benefits to individuals with advanced sensorineural hearing loss who are unable to gain effective speech recognition with hearing aids . OBJECTIVE To determine the cost per quality -adjusted life-year ( QALY ) for adults receiving multichannel cochlear implants .  DESIGN Prospect i ve 12-month multicenter study using preference-based quality -of-life measures and total cost determinations , comparing profoundly hearing-impaired adult subjects with and without cochlear implants . SETTING Hospital-based and patient-re source clinics . PATIENTS Severely to profoundly hearing-impaired adult recipients of a cochlear implant and adults eligible for the device who had not yet received it . MAIN OUTCOME MEASURE Clinical assessment of implant participants included medical and audiologic ( speech underst and ing ) data at the time of enrollment , 6 months , and 12 months . All participants ' health-utility was assessed at the time of enrollment , 6 months , and 12 months using the Health Utility Index . One-year medical re source utilization and cost data included bills related to implants , patient diaries , charge estimates from clinical sites , and published literature . A decision model was developed to determine cost per QALY . RESULTS Of the 84 enrolled adults , 62 ( 75 % ) completed the study .  Mean health-utility scores at the time of enrollment were identical between groups . The marginal 12-month health-utility gain for implant recipients was 0.20 ; 90 % of this improvement was achieved within 6 months . For patients with a mean 22-year life expectancy , the marginal cost per QALY was $ 14,670 . CONCLUSIONS Overall , multichannel cochlear implants significantly improved recipients ' performance on measures of speech underst and ing and ratings of health-utility within 6 months of implantation . The multichannel cochlear implant yielded a very favorable cost per QALY OBJECTIVE Cancer-related anorexia/cachexia syndrome and oxidative stress play a key role in the progression and outcome of neoplastic disease . PATIENTS AND METHODS On the basis of our previously published studies and clinical experience , we have developed an innovative approach consisting of diet with high polyphenol content ( 400 mg ) , p.o . pharmaconutritional support enriched with n - 3 fatty acids ( eicosapentaenoic acid and docosahexaenoic acid ) 2 cans ( 237 mL each ) per day , medroxiprogesterone acetate 500 mg/d , antioxidant treatment with alpha-lipoic acid 300 mg/d plus carbocysteine lysine salt 2.7 g/d plus vitamin E 400 mg/d plus vitamin A 30,000 IU/d plus vitamin C 500 mg/d , and selective cyclooxygenase-2 inhibitor Celecoxib 200 mg/d . The treatment is administered for 16 weeks . The following variables are evaluated : ( a ) clinical variables ( stage and Eastern Cooperative Oncology Group performance status ) ; ( b ) nutritional variables ( lean body mass , appetite , and resting energy expenditure ) ; ( c ) laboratory variables ( serum levels of proinflammatory cytokines , C-reactive protein , and leptin and blood levels of reactive oxygen species and antioxidant enzymes ) ; and ( d ) quality of life variables ( European Organization for Research and Treatment of Cancer QLQ-C30 , EQ-5Dindex , and EQ-5DVAS ) . A phase II nonr and omized study has been design ed to enroll 40 patients with advanced cancer at different sites with symptoms of cancer-related anorexia/cachexia syndrome and oxidative stress . RESULTS As of January 2004 , 28 patients have been enrolled : 25 patients were evaluable and 14 of them have completed the treatment ( 20 patients have completed 2 months of treatment ) . As for clinical response , five patients improved , three patients remained unchanged , and six patients worsened . The Eastern Cooperative Oncology Group performance status ( grade ) 1 remained unchanged . As for nutritional/functional variables , the lean body mass increased significantly at 2 and 4 months . As for laboratory variables , reactive oxygen species decreased significantly and proinflammatory cytokines interleukin-6 and tumor necrosis factor-alpha decreased significantly . As for quality of life , it comprehensively improved after treatment . CONCLUSIONS The treatment has been shown to be effective for clinical response , increase of lean body mass , decrease of reactive oxygen species and proinflammatory cytokines , and improvement of quality of life . The treatment has been shown to be safe with good compliance of patients . The study is in progress ( 14 further patients will be included ) Hearing aids ( HAs ) are often left unused . Several investigations have shown that the use of HAs and the skills to use them can be significantly improved through counselling . Follow-up counselling is often restricted by increased cost . The objective of the study was to assess the cost and the effect of follow-up counselling  on HA use . In a prospect i ve pre-post design study , 98 first-time HA users were counselled 6 months after the fitting of a HA , and the use of and benefit from HAs were measured by means of an interview and the short form of the hearing h and icap inventory for the elderly ( HHIE-S ) and the EuroQoL ( EQ-5D ) question naires . The results obtained before and 6 months after counselling were compared and the cost of counselling was calculated . After follow-up counselling , over half of the occasional users of a HA and as many as one third of the non-users became regular users . The number of regular users increased by 16 subjects , and non-users decreased from 29 subjects to 17 . The HHIE-S results showed a significant positive change , but the EQ-5D results showed practically no change . The additional expense of follow-up counselling at home was approximately 8.8 % ( € 83 per visit ) of the calculated € 942 cost of fitting a HA . Bringing one unused HA into regular use required € 508 . The results show that HA use and the consequent benefit can be significantly increased through counselling . The expense caused by follow-up counselling at home is highly acceptable in addition to the cost of fitting a HA OBJECTIVE To describe parental perspectives on health status and health-related quality of life ( HRQL ) at age 10 years in children with birth weights less than 1251 g who participated in the multicenter Cryotherapy for Retinopathy of Prematurity ( CRYO-ROP ) study . METHODS In 244 participants in the r and omized CRYO-ROP trial and 102 CRYO-ROP participants who did not develop ROP , the Health Utilities Index ( HUI ) system was used to characterize health status for the following 8 attributes : vision , hearing , speech , ambulation , dexterity , emotion , cognition , and pain . Using a utility formula , HRQL was determined for each child on a scale from 0.0 ( dead ) to 1.00 ( perfect health ) . RESULTS The proportion of the ROP-r and omized group with limitations in 4 attributes or more was 20.6 % compared with 2.0 % for the no-ROP group . Within the ROP-r and omized group , the proportion of " sighted " children with limitations in 4 attributes or more was 6.4 % vs 46.5 % in the " blind/low vision " group . The median HRQL score for the ROP-r and omized children was lower than for the no-ROP children ( 0.72 vs 0.97 , P<.001 ) ; the median HRQL score for the sighted-r and omized children was 0.87 vs 0.27 for the blind/low vision children ( P<.001 ) . CONCLUSIONS Threshold ROP was associated with functional limitations in health attributes and reduction in HRQL scores at age 10 years . Furthermore , among children who developed threshold ROP , a greater reduction in HRQL scores was found among children with a poor visual outcome compared with those with better sight We studied the impact of CHOP chemotherapy on the quality of life ( QoL ) of elderly patients with aggressive non-Hodgkin 's lymphoma ( NHL ) . 132 patients aged 65 or older , who participated in a r and omized , multicenter trial , completed QoL question naires ( EuroQol-5D , EORTC QLQ-C30 and MFI-20 ) on 8 predefined time-points before , during and following treatment . At baseline , QoL was significantly better on almost all dimensions in patients with a lower compared to patients with a higher age-adjusted International Prognostic Index ( aaPI ) . During treatment , physical and role functioning and global QoL deteriorated and fatigue increased in the lower aaPI group , whereas QoL of the higher aaPI group remained stable . During follow-up , the QoL was significantly better for patients in complete response ( CR ) or partial remission ( PR ) than for patients with progression/relapse . Soon after completion of therapy , the QoL of the lower aaPI group returned to pretreatment levels or better , while patients with higher aaPI showed a significant improvement in QoL compared to baseline levels . The effect of CHOP on the quality of life of elderly patients could be used in counseling this group of patients PURPOSE We developed a self-administered paper based instrument to assess patient preferences quantified as utilities for common outcomes associated with the management of prostate cancer . MATERIAL S AND METHODS A total of 50 patients was invited to test a self-administered paper based instrument design ed to assess preferences for health outcomes associated with the management of localized prostate cancer . The 50 patients were selected from a group of 625 r and omly identified men with prostate cancer who responded to a survey instrument design ed to assess health related quality of life . The 50 patients selected for this pilot project were chosen because of the wide range of responses to the  quality of life survey . Patient utilities were assessed for the 5 health states of overall quality of life , problems related to prostate cancer , and problems related to urinary , bowel and sexual dysfunction . RESULTS Patients were able to complete the assigned tasks . The self-administered instrument had high test-retest reliability . In addition results obtained from this instrument showed a correlation with results obtained from assessment s using other instruments , including an analog scale , a computer based system known as U-Titer , a quality of life survey and the Health Utility Index:3 . CONCLUSIONS A self-administered paper based instrument can be used to assess patient utilities for health states associated with prostate cancer management . Results from the instrument tested appear to be reliable and valid , and are comparable to those obtained from other assessment techniques . A self-administered paper based instrument has distinct advantages when conducting large survey studies because it can be incorporated at relatively low cost Objective We estimated the quality of life impact of vision loss in a community-based population with diabetes . Design and methods We r and omly surveyed 4,000 members of a large health maintenance organization with type 2 diabetes to assess  quality of life using the EQ-5D instrument .  Visual acuity was obtained by automated text processing of clinical notes recorded during the two years preceding subjects ’ surveys . Natural language processing was used to collect data from electronic medical records and to read clinical notes to determine the stage of retinopathy . Linear regression was used to model quality of life scores . Results Of the 4,000 surveys sent , approximately 55 % of patients responded . Patients with ≥20/20 acuity reported the highest mean utility ( mean = 0.82 ) , which declined as the visual angle doubled to 20/40 ( mean = 0.75 ) , and then doubled again to ≤20/80 ( mean = 0.71 ) . Perfect utility ( 1.0 ) was reported by 28 % of the sample . Only 7 % of patients suffered visual impairment ( ≤20/40 ) , and lower levels of visual acuity rarely occurred . Compared with patients with ≥20/20 acuity , the first doubling of the visual angle ( 20/40 ) lowered utility by three points ( 95 % confidence interval [ CI ] , −0.05 to −0.01 ) , and the second doubling of the visual angle ( ≤20/80 ) lowered utility by six points ( 95%CI , −0.10 to −0.02 ) . Conclusions This study aim ed to estimate disutility associated with visual loss in patients with diabetes using a community-based sample and controlled for many characteristics associated with quality of life . We found a smaller utility decrement compared to other studies , suggesting that visual acuity ’s impact on the quality of life for patients with diabetes in the community setting differs from more selected population The cost-effectiveness of autologous peripheral blood stem cell transplantation ( PBSCT ) compared with autologous bone marrow transplantation ( ABMT ) for refractory or relapsed non-Hodgkin 's lymphoma ( NHL ) or Morbus Hodgkin ( MH ) was assessed . Costs were determined from the induction chemotherapy regimen up to 3 months after discharge from hospital following the transplantation . Quality of life was measured by the EuroQol , the Rotterdam Symptom Checklist ( RSCL ) and the SF-36 .  Patients were r and omised according to a 2:1 ratio to undergo either PBSCT or ABMT  . 62 patients underwent PBSCT and 29 ABMT .  Costs of the transplantation period were significantly lower in the PBSCT group ( 15008 Euros ) than in the ABMT group ( 19000 Euros ) . Significant differences in quality of life were all in favour of PBSCT and emerged using the RSCL , both on 14 days after the transplantation and three months after discharge . We conclude that PBSCT is associated with lower costs and a better quality of life than ABMT for patients with refractory or relapsed NHL or MH The objective of this study was to evaluate  hearing aid fitting  from a societal viewpoint , rather than the more traditional patient perspective . The effects of hearing aid fitting on generic quality of life ( EuroQol ) , social functioning ( SF36 ) , auditory disability , productivity at paid and unpaid labour , and medical consumption , were assessed in a prospect i ve study among 80 moderately hearingimpaired first-time hearing aid applicants . The study showed that hearing aid fitting solved problems with paid employment , but did not seem to affect unpaid work . Use of medical services remained relatively stable after first-time hearing aid fitting . The Amsterdam Inventory proved to be a useful question naire to assess the effects on hearing disability . No effects of hearing aid fitting on generic quality of life could be determined with the EuroQol , while hearing aid fitting did lead to an improvement in one aspect of generic quality of life ; namely social functioning . El objetivo de este estudio fue evaluar la adaptación de auxiliares auditivos desde un punto de vista social , más que desde la perspective tradicional del paciente . Los efectos de la adaptación de auxiliares auditivos en la calidad genérica de vida ( EuroQWol ) , funcionamiento social ( SF36 ) , discapacidad auditiva , productividad en el trabajo remunerado o no remunerado , además de gastos médicos , fueron evaluados en un estudio prospect ivo con 80 pacientes con impedimentos auditivos moderados a quienes se les adaptó por primera vez un auxiliar auditivo . El estudio mostró que la adaptación de auxiliares auditivos resuelve problemas en los empleos remunerados pero no parece afectar el trabajo sin remuneración . El uso de servicios médicos permaneció relativamente estable después de la primera adaptación . El cuestionario Amsterdam probó ser un instrumento útil para evaluar los efectos en la discapacidad auditiva . No se pudieron determinar los efectos de la adaptación de auxiliares auditivos en la calidad genérica de vida por medio del EuroQol , mientras que la adaptación de auxiliares auditivos condicionó la mejoría en un aspecto de la calidad genérica de vida , que es concretamente , el funcionamiento social Background : Assessing health status in survivors of childhood cancer is increasingly important due to improved survival rates . However , there are limited estimates available for this population based on large sample s and compared to population controls . Methods : In a retrospective cohort study , 2152 long-term survivors and 2432 controls , aged 5–37 , who had survived cancer during childhood or adolescence were compared on the Health Utilities Index Mark III ( HUI3 ) . Descriptive and logistic regression analyses were used to assess the effect of age at diagnosis , type of cancer and therapy received on HUI3 domains . Major findings : More survivors than controls showed deficits in dexterity , ambulation , hearing , speech and cognition but not in vision , emotion or pain . The largest numbers of survivors reporting excess impairment was found in the cognition attribute . Survivors of central nervous system tumors were most likely to show impairments across multiple domains . Lastly , impairments in cognition were found most commonly in survivors exposed to cranio-spinal radiation at young ages . Conclusions : Seventy-five percent of childhood cancer survivors and 80 % of controls were found to have two or fewer impaired attributes . Those reporting impairments that were most likely to be of clinical relevance were among survivors diagnosed with central nervous system and bone tumours , and those exposed to cranial radiation as young children . Tools assessing health status should be included in prospect i ve trials to more clearly assess the contribution of therapy to reduced long-term health status Metal stent placement and single dose brachytherapy are commonly used treatment modalities for the palliation of inoperable oesophageal carcinoma . We investigated generic and disease-specific health-related quality of life ( HRQoL ) after these palliative treatments . Patients with dysphagia from inoperable oesophageal carcinoma were r and omised to placement of a covered Ultraflex stent ( n = 108 ) or single dose ( 12 Gy ) brachytherapy ( n = 101 ) . We obtained longitudinal data on disease-specific ( dysphagia score , European Organisation for Research and Treatment of Cancer ( EORTC ) OES-23 , visual analogue pain scale ) and generic ( EORTC Quality of Life-Core 30 Question naire ( QLQ-C30 ) , Euroqol (EQ)-5D ) HRQoL at monthly home visits by a specially-trained research nurse . We compared HRQoL between the two treatments and analysed changes in HRQoL during follow-up . Dysphagia improved more rapidly after stent placement than after brachytherapy , but long-term relief of dysphagia was better after brachytherapy . For generic HRQoL , there was an overall significant difference in favour of brachytherapy on four out of five functional scales of the EORTC QLQ-C30 ( role , emotional , cognitive and social ) ( P < 0.05 ) . Generic HRQoL deteriorated over time on all functional scales of the EORTC QLQ C-30 and EQ-5D , in particular physical and role functioning ( on average -23 and -24 on a 100 points scale during 0.5 years of follow-up ) . This decline was more pronounced in the stent group . Major improvements were seen on the dysphagia and eating scales of the EORTC OES-23 , in contrast to other scales of this disease-specific measure , which remained almost stable during follow-up . Reported levels of chest or abdominal pain remained stable during follow-up in both treatment groups , general pain levels increased to a minor extent . The effects of single dose brachytherapy on HRQoL compared favourably to those of stent placement for the palliation of oesophageal cancer . Future studies on palliative care for oesophageal cancer should at least include generic HRQoL scales , since these were more responsive in measuring patients ' functioning and well-being during follow-up than disease-specific HRQoL scales OBJECTIVE To assess patient-reported outcomes ( PRO ) in patients with moderate-to-severe plaque psoriasis receiving continuous or paused etanercept treatment . METHODS In a multicentre European open-label study , one group ( n = 352 ) received continuous therapy : 25 mg subcutaneously ( SC ) twice weekly ( BIW ) throughout 54-weeks . The other group ( n = 359 ) received paused therapy : 50 mg SC BIW ( < or= 12 weeks ) until response was adequate by Physician Global Assessment ; after psoriasis returned , retreatment ( 25 mg BIW ) was begun . PRO included the Dermatology Life Quality Index ( DLQI ) , EuroQoL-5D ( EQ-5D ) , Hospital Anxiety and Depression Scale ( HADS ) , and the SF-36 Vitality subscale . RESULTS At baseline , mean DLQI for patients in the continuous ( 12.8 ) and paused group ( 13.8 ) , indicated significant quality -of-life impairment ; mean EQ-5D utility scores were 0.65 and 0.66 for continuous and paused patients , respectively ; 30.0 % of continuous and 37.0 % of paused patients had at least mild symptoms of depression ; 40.2 % and 48.6 % , respectively , had at least mild symptoms of anxiety . At week 54 , both groups showed statistically significant ( P < 0.05 ) and meaningful improvement in DLQI and EQ-5D scores ; improvements in HADS-D , HADS-A , and SF-36 vitality were also significant . Improvements in DLQI and EQ-5D were significantly greater in the continuous arm than the paused arm , but the differences were not meaningful . Differences between arms in HADS and SF-36 Vitality at week 54 were not significant . CONCLUSIONS At baseline , patients exhibited significant quality -of-life impairment . Both continuous and paused etanercept treatment provided improvements in PRO measures . Either regimen could be considered and care should be individualized OBJECTIVES To investigate the subjective well-being of patients with newly diagnosed multiple myeloma who were treated in a t and em transplantation programme .  METHODS Fifty-one patients participated in the prospect i ve , longitudinal question naire study . The EORTC QLQ-C30 and the EuroQol-5D were administered 2 wk after completion of vincristine , adriamycin and dexamethason/vincristine , adriamycin and methyl prednison ( VAD/VAMP ) chemotherapy , both at hospital discharge after treatment with high-dose melphalan ( HDM ) and 1 month after this hospital discharge , at hospital admission , at the day of hospital discharge for peripheral stem cell transplantation ( PSCT ) and at 6 and 12 months following discharge after PSCT . RESULTS Overall , patients ' functioning improved during treatment and follow-up , with significant decreases shortly following PSCT . Shortly after HDM and PSCT , patients reported a considerable increase in levels of soreness in the mouth ( + 26/+36 points on a scale ranging form 0 to 100 ; P < 0.01 ) , change of taste ( + 23/+21 points ; P < 0.05/NS ) , nausea/vomiting ( + 26/+27 points ; P < 0.01/ < 0.05 ) , appetite loss ( + 40/+43 points ; P < 0.001 ) and diarrhoea ( + 25/+36 points ; P < 0.01 ) . However , none of these symptoms persisted during follow-up . CONCLUSION The intensive treatment programme was subjectively being well tolerated by the majority of patients . The duration of declined quality of life after administration of HDM seemed to be short . The duration of subjective recovery after PSCT remained uncertain , but in any case was present at the 6 month follow-up . Together with the rather good results in survival , the evaluation of quality of life invites further exploration of double transplantations in multiple myeloma Introduction : The effect on quality of life by healing leg ulcers is not known and no vali date d disease-specific tool is available for measuring health-related quality of life ( HRQoL ) for people with venous leg ulcers . The objective of this paper was to compare four generic instruments [ MOS 36-Item Short-Form Health Survey ( SF-36 ) ; EuroQol ( EQ ) ; McGill Short Form Pain Question naire ( SF-MPQ ) and the  Frenchay Activities Index ( FAI ) ] used for measuring HRQoL in people with venous leg ulcers , and to offer guidance on the most appropriate tool for research ers . Methods : Two hundred and thirty-three patients with venous leg ulcers were recruited as part of a r and omised controlled trial of the cost-effectiveness of community leg ulcer clinics . Subjects completed question naires containing the four instruments on three occasions ( initial assessment , 3 and 12 months ) . The discriminative and evaluative properties of the four instruments were compared . Results : All four instruments were acceptable to patients , taking a mean of 19.3 ( SD 6.3 ) min to complete . At initial assessment , the SF-MPQ had poorer discriminative properties than the other three instruments and was not able to distinguish between the different patient groups in relation to age and ulcer duration . The FAI was good at discriminating between the different patient groups ( at initial assessment ) in relation to age , mobility and ulcer size . At the three-month follow-up , the SF-MPQ was more responsive than the other measures and detected changes in HRQoL , whereas the EQ and SF-36 did not . At 12 months , the SF-MPQ still identified differences and the SF-36 and EQ also did at this stage . Conclusion : In the absence of a vali date d condition-specific tool for measuring changes in general health status for patients with venous leg ulcers , we make the following recommendations . For evaluating the outcome of interventions with a short-term follow-up ( three months ) in a clinical study we recommend the SF-MPQ and for 12-month follow-up in a clinical study the SF-36 , with or without the SF-MPQ The purpose of this study was to compare the performance of measures of health-related quality of life in a r and omized controlled trial of respiratory rehabilitation versus conventional community care for patients with chronic airflow limitation . The study included 89 stable patients with moderate to severe chronic airflow limitation with measurement of health status at 12 , 18 , and 24 weeks . Outcomes included two disease-specific ( the Oxygen Cost Diagram and the Chronic Respiratory Question naire [ CRQ ] ) measures , a generic health profile ( the Sickness Impact Profile [ SIP ] ) , and two utility measures ( the St and ard Gamble and the Quality of Well-Being index [ QWB ] ) . Of the measures , only the four domains of the CRQ ( dyspnea , fatigue , mastery , and emotional function ) showed statistically significant differences ( P < or = 0.05 ) between treatment and control groups . Correlation between change in the CRQ and change in other relevant measures , including the 6-minute walk test and global ratings of change in dyspnea , fatigue , and emotional function were generally weak to moderate ( from 0.19 to 0.51 ) . All correlations between change in the QWB , SIP , and St and ard Gamble and other measures were very weak or weak ( up to 0.30 ) . Correlation between change in the three generic measures were all very weak ( < 0.15 ) . The results suggest that unless investigators include responsive and valid disease-specific measures of health-related quality of life in controlled trials in chronic diseases , they risk misleading conclusions about the effect of treatments on health status Purpose : The EQ-5D is a brief , multiattribute , preference-based health status measure . This article describes the development of a statistical model for generating US population -based EQ-5D preference weights . Methods : A multistage probability sample was selected from the US adult civilian noninstitutional population . Respondents valued 13 of 243 EQ-5D health states using the time trade-off ( TTO ) method . Data for 12 states were used in econometric modeling . The TTO valuations were linearly transformed to lie on the interval [ −1 , 1 ] . Methods were investigated to account for interaction effects caused by having problems in multiple EQ-5D dimensions . Several alternative model specifications ( eg , pooled least squares , r and om effects ) also were considered . A modified split- sample approach was used to evaluate the predictive accuracy of the models . All statistical analyses took into account the clustering and disproportionate selection probabilities inherent in our sampling design . Results : Our D1 model for the EQ-5D included ordinal terms to capture the effect of departures from perfect health as well as interaction effects . A r and om effects specification of the D1 model yielded a good fit for the observed TTO data , with an overall R2 of 0.38 , a mean absolute error of 0.025 , and 7 prediction errors exceeding 0.05 in absolute magnitude . Conclusions : The D1 model best predicts the values for observed health states . The result ing preference weight estimates represent a significant enhancement of the EQ-5D 's utility for health status assessment and economic analysis in the US Summary : This prospect i ve longitudinal study examined both short- and long-term changes in health-related quality of life ( HRQL ) in 52 breast cancer patients with poor prognosis receiving high-dose chemotherapy ( HDC ) treatment with autologous blood stem cell transplantation ( ASCT ) .  HRQL was measured seven times from baseline to 2 years post enrollment with the Functional Living Index-Cancer ( FLIC ) , the EuroQol ( EQ-5D ) , and a  quality of life visual analogue scale . The percentage of question naires returned at each assessment time ranged from 80 to 92 % . All three measures showed a similar pattern of change , with HRQL decreasing following administration of HDC , and returning to baseline levels 8 weeks post HDC . A repeated- measures analysis of variance showed that the FLIC at 2 years was significantly better than baseline ( P=<0.0001 ) . Difficulty sleeping , headaches , and decreased sexual interest were the most common symptoms reported in the longer term . Our results have implication s for early psychosocial intervention in the care of breast cancer patients with poor prognosis undergoing treatment with HDC and ASCT because such interventions can further improve the quality of their survival PURPOSE To evaluate the effect of cytomegalovirus ( CMV ) retinitis on quality of life ( QOL ) in patients with the acquired immune deficiency syndrome ( AIDS ) . DESIGN Enrollment data from a multicenter , prospect i ve cohort study . PARTICIPANTS Patients > /=13 years of age with AIDS in three groups : no CMV retinitis , 709 patients ; long-st and ing CMV retinitis ( diagnosed a median of 34.5 months previously ) , 212 patients ; and newly diagnosed CMV retinitis ( diagnosed < /=45 days previously ) , 50 patients . METHODS Patients were enrolled at 19 centers throughout the United States . CMV retinitis status was determined by ophthalmoscopy .  Vision-related QOL was assessed with a question naire design ed for patients with CMV retinitis . General health-related QOL was evaluated with a modified version of the Medical Outcomes Survey-HIV instrument .  Health utility was measured with the EuroQol instrument . MAIN OUTCOME MEASURES Patient-reported vision-related QOL , general health-related QOL , and health utility . RESULTS All domains of vision-related QOL were substantially lower in both the long-st and ing and newly diagnosed CMV retinitis groups than in the group with no CMV retinitis . The long-st and ing CMV retinitis group was similar to the no CMV retinitis group in most general health-related QOL domains and in health utility measures . The newly diagnosed CMV retinitis group scored substantially worse than the other groups in many of the general health-related QOL domains and in visual analog scale-measured health utility . Adjustment of selected scale scores for demographic characteristics and for CD4(+ ) T-cell count , human immunodeficiency virus viral load , and use of highly active antiretroviral therapy ( HAART ) attenuated most of the differences in general health-related QOL , except that physical function scores remained significantly lower in the newly diagnosed CMV retinitis group . Adjustment did not alter the pattern of vision-related QOL results . CONCLUSIONS These results suggest that in the HAART era , CMV retinitis is associated with reduced vision-related QOL in patients both with newly diagnosed and with long-st and ing disease , even though patients with long-st and ing CMV retinitis seem to have general health-related QOL and health utility similar to that of patients with AIDS who do not have CMV retinitis . Newly diagnosed CMV retinitis also is associated with lower general health-related QOL in most domains and with lower health utility Background : Psoriasis substantially impairs the health‐related quality of life ( HRQOL ) of patients , and a comprehensive evaluation of treatment includes HRQOL measures . Objective : To assess the impact of adalimumab on patient‐reported outcomes ( PROs ) of patients with moderate to severe psoriasis . Methods : In a Phase II , r and omized , controlled trial , the efficacy and safety of two dosages of adalimumab ( 40 mg weekly or every other week ) versus placebo were assessed for 12 weeks in the treatment of moderate to severe plaque psoriasis . Patients completed the Dermatology Life Quality Index ( DLQI ) , Short‐Form 36 ( SF‐36 ) Health Survey , and EuroQOL‐5D ( EQ‐5D ) at baseline and 12 weeks . The primary endpoint was the percentage of patients achieving a ⩾75 % reduction in the Psoriasis Area and Severity Index score ( PASI 75 ) . Investigators assessed PASI and Physician 's Global Assessment ( PGA ) scores . Results : Adalimumab patients ( either dosage ) displayed significantly greater improvements versus placebo patients in DLQI , EQ‐5D , and SF‐36 Mental Component Summary scores , as well as in Bodily Pain , Vitality , Social Functioning , Role – Emotional , and Mental Health domains . The adalimumab 40‐mg weekly group also reported significantly greater improvements in SF‐36 Physical Component Summary scores versus the placebo group . Conclusion : Both adalimumab dosages were efficacious in improving dermatology‐specific and general PROs in patients with moderate to severe psoriasis Background . Mapping disease-specific instruments into generic health outcomes or utility values is an exp and ing field of interest in health economics . This article constructs an algorithm to translate the modified Rankin scale ( mRS ) into EQ-5D utility values . Methods .  mRS and  EQ-5D  information was derived from stroke or transient ischemic attack ( TIA ) patients identified as part of the Oxford Vascular study ( OXVASC ) .  Ordinary least squares ( OLS ) regression was used to predict UK EQ-5D tariffs from mRS scores . An alternative method , using multinomial logistic regression with a Monte Carlo simulation approach ( MLogit ) to predict responses to each EQ-5D question , was also explored . The performance of the models was compared according to the magnitude of their predicted-to-actual mean EQ-5D tariff difference , their mean absolute and mean squared errors ( MAE and MSE ) , and associated 95 % confidence intervals ( CIs ) . Out-of- sample validation was carried out in a subset of coronary disease and peripheral vascular disease ( PVD ) patients also identified as part of OXVASC but not used in the original estimation . Results . The OLS and MLogit yielded similar MAE and MSE in the internal and external validation data sets . Both approaches also underestimated the uncertainty around the actual mean EQ-5D tariff producing tighter 95 % CIs in both data sets . Conclusions . The choice of algorithm will be dependent on the study aim . Individuals outside the United Kingdom may find it more useful to use the multinomial results , which can be used with different country-specific tariff valuations . However , these algorithms should not replace prospect i ve collection of utility data OBJECTIVES To assess the impact of a bone-anchored hearing aid ( BAHA )  on the  quality of life ( QOL ) of adults and to test the hypothesis that a BAHA improves QOL because otorrhea and /or skin irritations decrease . DESIGN Prospect i ve postal-based question naire study using vali date d health-related QOL instruments , combined with hearing-aid-related questions . PATIENTS AND METHODS The study included 56 consecutive adult patients with acquired conductive or mixed hearing loss who were scheduled for BAHA implantation at the University Medical Centre Nijmegen , Nijmegen , the Netherl and s. All 56 patients completed the 36-Item Short-Form  Health  Survey  ( SF-36 ) , the EuroQol-5D ( EQ-5D ) , and the Hearing H and icap and Disability Inventory ( HHDI ) ; 36 patients had been using an air-conduction hearing aid ( ACHA ) and 20 patients a conventional bone-conduction hearing aid ( CBHA ) .  Question naires were filled out before surgery and after 6 months of experience with the BAHA . RESULTS In the SF-36 group , there was significant improvement in the scores of the mental health domain ( P = .02 ) . When the SF-36 patients were classified according to previous hearing aid , there was no statistically significant change in the scores in any of the domains . In the EQ-5D group and in its ACHA and CBHA subgroups , there were no important differences in the results before and after the patients received their BAHAs . In the HHDI group , the h and icap and disability scales showed significant improvement ( P<.01 ) irrespective of the type of previously worn hearing aid . CONCLUSIONS Overall , generic health-related QOL was not influenced significantly by the use of a BAHA according to the SF-36 and the EQ-5D . The more disease-specific scales ( HHDI ) did show improved QOL with a BAHA There remains disagreement about the preferred utility-based measure of health-related quality of life for use in constructing quality -adjusted life years ( QALYs ) . The recent development of a new measure , the SF-6D , has highlighted this issue . The SF-6D and EuroQol EQ-5D measure health-related utilities on a scale where 0 represents death and 1 represents full health , and both have utility scores generated from r and om sample s of the general UK population . This study explored whether , in a large sample of liver transplant patients , the two instruments provide similar results . The empirical data highlight important variation in the results generated from the use of the two instruments . The data are consistent with a view that the SF-6D does not describe health states at the lower end of the utility scale but is more sensitive than EQ-5D in detecting small changes towards the top of the scale We prospect ively compared the proxy reporting of  health‐related quality of life ( HRQL ) by parents and nurses of children with Hodgkin disease to see how well they correlated with the children 's report BACKGROUND Patient-reported outcomes ( PROs ) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient 's perspective . This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index ( FCSI-9 ) in a metastatic colorectal cancer ( mCRC ) population . METHODS The FCSI-9 and EQ-5D were administered every 2 - 4 weeks to mCRC subjects in a phase III clinical trial . Three hundred ninety-one mCRC subjects completed the question naires at baseline and at least one follow-up assessment . Internal consistency reliability , test-retest reliability , construct validity , known groups validity , responsiveness , and the minimum important difference ( MID ) of the FCSI-9 were evaluated . RESULTS The internal consistency and test-retest reliability of the FCSI-9 were acceptable ( 0.81 and 0.76 , respectively ) . Construct validity was supported based on moderate correlations with the EQ-5D . Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status ( PS ) score . Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8 . Responsiveness , as measured by Guyatt 's statistic , was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12 . Considering all data together , the MID of the FCSI-9 is estimated to be in the range of 1.5 - 3.0 points . CONCLUSION Results provide preliminary evidence of the reliability , validity , and responsiveness of the FCSI-9 The aim of this study was to assess the effects of fitting a hearing aid by measuring the benefits derived from hearing aid use . Besides audiologic tests , a short version of the Hearing H and icap Inventory for the Elderly , and the EuroQol question naire were used in a prospect i ve study . Ninety-eight first-time hearing aid users were interviewed prior to , and six months after , the fitting of their  first hearing aids .  The total HHIE-S score changed from 28.7 before , to 12.7 six months after , hearing aid fitting . Altogether 40%–60 % of the users reported fewer social or emotional problems . There was a statistically significant positive change in the EQ-VAS score . According to the HHIE-S , hearing aids clearly alleviated hearing disability . The EQ-5D question naire was not sensitive enough for measuring the health-related quality of life of subjects with hearing impairment . Sumario El objetivo de este estudio fue evaluar los efectos de la adaptación de AA midiendo los beneficios derivados de su uso . Además de las pruebas audiológicas se usaron en un estudio prospect ivo los Cuestionarios de Discapacidad Auditiva en los ancianos ( HHIE-S ) , en versión corta y el EuroQol . Se entrevistaron 98 usuarios de AA de primera vez , antes y seis meses después de la adaptación de sus primeros AA . La puntuación total del HHIE-S cambió de 28.7 en el estudio basal a 12.7 seis meses después de la adaptación . Alrededor del 40 - 60 % de los usuarios reportaron pocos problemas sociales o emocionales . Se apreció un cambio positivo , estadísticamente significativo , en la puntuación del EQ-VAS . De acuerdo con el HHIE-S , los AA claramente mitigaron la discapacidad auditiva . El cuestionario EQ-5D no fue lo suficientemente sensible para medir la calidad de vida relacionada con la salud , en las personas con impedimento auditivo Objectives : Following a 3.7-fold increase in the rate of cataract surgery in the UK between 1989 and 2004 , concern has been raised as to whether this has been accompanied by an excessive decline in the threshold such that some operations are inappropriate . The objective was to measure the impact of surgery on a representative sample of patients so as to determine whether or not overutilisation of surgery is occurring . Design : Prospect i ve cohort assessed before and 3 months after surgery . Setting : Ten providers ( four NHS hospitals , three NHS treatment centres , three independent sector treatment centres ) from across Engl and . Participants : 861 patients undergoing first eye ( 569 ) or second eye ( 292 ) cataract surgery  provided preoperative data of whom 745 ( 87 % ) completed postoperative question naires . Main outcome measures : Patient-reported visual function ( VF-14 ) ; general health status and quality of life ( EQ5D ) ; postoperative complications ; overall view of the operation and its impact . Results : Overall , visual function improved ( mean VF-14 score increased from 83.2 ( SD 17.3 ) to 93.7 ( SD 13.2 ) ) . Self-reported general health status deteriorated ( 20.3 % fair or poor before surgery compared with 25 % afterwards ) which was reflected in the mean EQ5D score ( 0.82 vs 0.79 ; p = 0.003 ) . At least one complication was reported by 66 ( 8.9 % ) patients , though this probably overestimated the true incidence . If the appropriateness of surgery is based on an increase in VF-14 score of 5.5 ( that corresponds to patients ’ reporting being “ a little better ” ) , 30 % of operations would be deemed inappropriate . If an increase of 12.2 ( patients ’ reports of being “ much better ” ) is adopted , the proportion inappropriate is 49 % . Using a different approach to determining a minimally important difference , the proportion inappropriate would be closer to 20 % . Although visual function ( VF-14 ) scores were unchanged or deteriorated in 25 % of patients , 93.1 % rated the results of the operation as “ good , ” “ very good ” or “ excellent , ” and 93.5 % felt their eye problem was “ better . ” This partly reflects inadequacies in the validity of the VF-14 . Conclusions : Improvement in the provision of cataract surgery has been accompanied by a reduction in the visual function threshold . However , method ological difficulties in measuring the impact of cataract surgery on visual function and quality of life mean it is impossible to determine whether or not overutilisation of cataract surgery is occurring An uncontrolled , preliminary evaluation of healing by gentle touch in clients with cancer was carried out at The Centre for Complementary Care in Eskdale , Cumbria . All clients attending The Centre between 1995 and 2001 were invited to participate . Data were collected from 35 clients with cancer . Outcome measures included pre- to post-treatment changes in physical and psychological functioning . Assessment s were made using a question naire with visual analogue scales for subjective rating of symptoms and the EuroQoL ( EQ-5D ) , a generic state of health measure . Wilcoxon Signed Ranks tests showed statistically significant improvements in psychological and physical functioning , with positive effects on quality of life . The most pronounced improvements were seen in ratings for stress and relaxation , severe pain/discomfort , and depression/anxiety , particularly in those with the most severe symptoms on entry . The study found no adverse effects result ing from the treatment . These findings indicate that healing is a safe and effective adjunct to conventional medical treatment with the potential to ameliorate some of the more stressful aspects of cancer , including those inherent in current cancer treatment strategies . Rigorous evaluation of this modality by prospect i ve , r and omised , controlled trial is strongly warranted , as are investigations into its potential for use in palliative care PURPOSE Quality of life ( QOL ) outcomes in patients with chronic myeloid leukemia ( CML ) were evaluated in an international phase III study . PATIENTS AND METHODS Newly diagnosed patients with chronic phase CML were r and omly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine ( IFN+LDAC ) . Cross-over to the other treatment was permitted because of intolerance or lack of efficacy . Patients completed cancer-specific QOL ( Functional Assessment of Cancer Therapy-Biologic Response Modifiers ) and utility ( Euro QoL-5D ) question naires at baseline and during treatment ( n = 1,049 ) . The primary QOL end point was the Trial Outcome Index ( TOI ; a measure of physical function and well-being ) . Secondary end points included social and family well-being ( SFWB ) , emotional well-being ( EWB ) , and the utility score . Primary analyses were intention to treat with secondary analyses accounting for cross-over . RESULTS Patients receiving IFN+LDAC experienced a large decline in the TOI , whereas those receiving imatinib maintained their baseline level . Treatment differences at each visit were significant ( P < .001 ) and clinical ly relevant in favor of imatinib .  Mean SFWB , EWB , and utility scores were also significantly better for those patients taking imatinib . Patients who crossed over to imatinib experienced a large increase in TOI ; significant ( P < .001 ) differences were observed between patients who did and did not cross over in favor of imatinib . CONCLUSION Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML . In addition , patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC AIMS The purpose of the present paper was to evaluate the effectiveness of mirtazapine orally disintegrating tablets for nausea and sleep disturbance , which are common and distressing symptoms of cancer . METHODS This was a 4-week , prospect i ve , open-labeled study of cancer patients . Assessment s were performed at baseline and on days 1 , 3 , 5 , 7 , 14 , and 28 . Primary outcome measures were the Clinical Global Impression scale for nausea/vomiting and the Chonnam National University Hospital-Leeds Sleep Evaluation Question naire ( C-LSEQ ) including total amount of night sleep time . The secondary outcome measures consisted of pain items in the 36-item Short Form Health Survey , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the EuroQoL (EQ)-5D .  Forty-two cancer patients were enrolled . RESULTS Those with nausea ( n = 28 ) improved significantly from day 1 . The total night sleep time and each item on the C-LSEQ improved from days 1 - 5 . The scores on the MADRS and the depression/anxiety dimension and visual analog scale of EQ-5D improved significantly from the first week . Pain measures also improved from day 1 . Exacerbation of sleepiness developed in approximately one-third of subjects during the initial few days , but disappeared gradually . CONCLUSION In the present study mirtazapine rapidly improved nausea , sleep disturbance , pain and quality of life , as well as depression in cancer patients .  Mirtazapine may be an effective treatment option in managing cancer patients with multiple distressing symptoms , including nausea and sleep disturbance Background . The Health Utilities Index Mark 3 ( HUI3 ) is a generic multiattribute preference‐based measure of health status and health‐related quality of life that is widely used as an outcome measure in clinical studies , in population health surveys , in the estimation of quality ‐adjusted life years , and in economic evaluations . HUI3 consists of eight attributes ( or dimensions ) of health status : vision , hearing , speech , ambulation , dexterity , emotion , cognition , and pain with 5 or 6 levels per attribute , varying from highly impaired to normal . Objectives . The objectives are to present a multiattribute utility function and eight single‐attribute utility functions for the HUI3 system based on community preferences . Study Design . Two preference surveys were conducted . One , the modeling survey , collected preference scores for the estimation of the utility functions . The other , the direct survey , provided independent scores to assess the predictive validity of the utility functions . Measures . Preference measures included value scores obtained on the Feeling Thermometer and st and ard gamble utility scores obtained using the Chance Board . Respondents . A r and om sample of the general population ( ≥16 years of age ) in Hamilton , Ontario , Canada . Results . Estimates were obtained for eight single‐attribute utility functions and an overall multiattribute utility function . The intraclass correlation coefficient between directly measured utility scores and scores generated by the multiattribute function for 73 health states was 0.88 . Conclusions . The HUI3 scoring function has strong theoretical and empirical foundations . It performs well in predicting directly measured scores . The HUI3 system provides a practical way to obtain utility scores based on community preferences Objective A group of 20 patients with large vestibular aqueduct syndrome was identified at the Indiana University School of Medicine . The major objective of this study was to explore the improvements in quality of life associated with cochlear implantation in patients with large vestibular aqueduct syndrome , as well as the cost-utility of cochlear implantation in this group . Setting A total of 70 patients were identified with large vestibular aqueduct syndrome through analysis of thin-section computed tomography of the temporal bone over the past 6 years at this medical center . Data collected from the medical records for each patient included demographic data , hearing-related statistics , implantation data , and audiometric data . Sixteen children and adults with large vestibular aqueduct syndrome had undergone cochlear implantation before the beginning of this study , and the remaining 54 children and adults were identified as undergoing treatment of progressive or fluctuant sensorineural hearing loss . Health utility indexes used in this analysis were taken through the use of the Ontario Health Utility Index , Mark III . The range of costs used for cost-utility analysis was derived from the costs of cochlear implantation at this medical center , as well as from costs associated with implantation published in the medical literature . Methods Participants were selected from the total population of patients with large vestibular aqueduct syndrome at this center who were postlingually deafened and who currently had severe hearing loss . Two groups were formed . These groups comprised either  cochlear implant patients with large vestibular aqueduct syndrome  or  patients  with  large vestibular aqueduct syndrome currently using hearing aids . Ten of the 16 cochlear implant patients and 10 of the remaining 54 patients with large vestibular aqueduct syndrome met these criteria . Mark III health utility indexes were distributed to patients in each group and scored . Those health utility indexes not completed by the patients were scored by proxy , using the audiologist at this center who was the most familiar with the patient . Changes in quality of life associated with cochlear implantation were derived by comparison of the health utility index results of the two groups . Cost-utility measures were then made using discounted costs per quality -of-life years ( QALYs ) ( 5 % ) , and a sensitivity analysis was performed that evaluated changes in scoring done by proxy . The cost-utility results were then compared with the cost-utilities derived from similar studies and associated with other disease states . Results Although both groups of patients had significant hearing loss , the hearing aid group had a better mean pure-tone average . The mean pure-tone average for the hearing aid group was 70.8 dB ( SD 24.4 ) , and the mean pure-tone average for the cochlear implant group was 107.0 dB ( SD 21.7 ) . Seven of the 20 health utility indexes were scored by proxy . Results from the base case indicate a 0.20 gain in health utility from cochlear implantation ( hearing aid = 0.62 , cochlear implant = 0.82 , p = 0.037 ) , result ing in a discounted cost per QALY of $ 12,774 . Sensitivity analysis of the proxy scoring indicated that decreasing the hearing score one level on the health utility index result ed in a gain in health utility with cochlear implantation of 0.15 , result ing in a discounted cost per QALY of $ 17,832 . A decrease of the hearing score by two levels on the health utility survey result ed in no significant gain in quality of life with cochlear implantation . Conclusion This study found an improvement in quality of life associated with cochlear implantation in postlingually deafened patients with large vestibular aqueduct syndrome . By weighing this improvement in quality of life against the significant difference noted between the pure-tone averages of each group , further strength can be given to this conclusion . This gain in quality of life , as well as the results derived for the cost-utility of cochlear implantation , was similar to that in previous published studies of cochlear implantation in all types of patients . These results also indicate a favorable cost-utility when compared with published data about other disease states . As patients with large vestibular aqueduct syndrome progress to profound levels of hearing loss , these results indicate that cochlear implantation can be offered as a beneficial , life-improving therapy Purpose Little is known about factors that affect health-related quality of life during the early follow-up of colorectal cancer . This study was design ed to identify the factors that contribute to poor health-related quality of life after six weeks of follow-up and to compare the relative performance of instruments best suited to measure it . Methods A single-center , prospect i ve study was design ed to examine health-related quality of life after  potentially curative surgery for colorectal cancer .  Two condition-specific and two generic instruments ( QLQ-C30 , FACT-C , SF12 and EQ-5D ) measured quality  of life six weeks after discharge . Univariate and multivariate analyses were used to assess the impact of 16 treatment factors , demographic variables , and symptoms on seven global health-related quality of life scores . Results Question naires were obtained from 201 consecutive patients . Five factors were associated with poor health-related quality of life scores at six-week follow-up in the multivariate analysis : reduced preoperative performance status , stomas , diarrhea , constipation , and younger than aged 65 years . No instrument out performed the others . However , condition-specific instruments and those in which patients subjectively rated their overall health-related quality of life were better suited to detect health-related quality of life differences relating to the effects of colorectal cancer treatment . Conclusions Younger patients , those with stomas , and those suffering from diarrhea or constipation are more likely to report poor health-related quality of life at six-week follow-up . The routine measurement of health-related quality of life using an instrument that includes a patient-rated scale together with condition-specific items could be used to detect patients at risk of poorer short-term health-related quality of life outcomes OBJECTIVES The aim of the study is to estimate a preference-based single index for calculating quality -adjusted life years for patients with overactive bladder ( OAB ) , based on a survey of the UK general population using the 5-dimensional health classification system OAB-5D , derived from the vali date d Overactive Bladder Question naire ( OAB-q ) . METHODS An interview valuation survey of members of public in the South Yorkshire , UK was undertaken using the time-trade-off method . Each respondent was r and omly allocated to one of 14 blocks , and valued seven states each plus the " pits " state , so that a total of 99 states were valued . A number of multivariate regression models were estimated for predicting a total of 3125 health state values defined by the classification . Models were compared and selected using a set of criteria , including overall diagnosis by adjusted R-squared , the sign and significance of individual parameter estimates , the relative size of coefficients within a given dimension and predictive ability . RESULTS The mean model was recommended for use in economic evaluation . CONCLUSION This will permit the cost-effectiveness of new interventions to be assessed in patients with OAB using existing and future OAB-q data sets Background Psoriasis is a common disease and may have a significant impact on patients ' quality of life ( QoL ) . OBJECTIVES To estimate models , via ordinary least squares regression , for predicting Euro Qol 5D ( EQ-5D ) , Short Form 6D ( SF-6D ) , and 15D utilities from scale scores of the European Organization for Research and Treatment of Cancer Quality of Life Question naire ( EORTC QLQ-C30 ) . METHODS Forty-eight gastric cancer patients , split up into equal subgroups by age , sex , and chemotherapy scheme , were interviewed , and the survey included the QLQ-C30 , SF-36 , EQ-5D , and 15D instruments , along with sociodemographic and clinical data . Model predictive ability and explanatory power were assessed by root mean square error ( RMSE ) and adjusted R(2 ) values , respectively . Pearson 's r between predicted and reported utility indices was compared . Three r and om sub sample s , half in size the initial sample , were created and used for " external " validation of the modeling equations . RESULTS Explanatory power was high , with adjusted R(2 ) reaching 0.909 , 0.833 , and 0.611 for 15D , SF-6D , and EQ-5D , respectively . After normalization of RMSE to the range of possible values , the prediction errors were 12.0 , 5.4 , and 5.6 % for EQ-5D , SF-6D , and 15D , respectively . The estimation equations produced a range of utility scores similar to those achievable by the st and ard scoring algorithms . Predicted and reported indices from the validation sample s were comparable thus confirming the previous results . CONCLUSIONS Evidence on the ability of QLQ-C30 scale scores to validly predict 15D and SF-6D utilities , and to a lesser extent , EQ-5D , has been provided . The modeling equations must be tried in future studies with larger and more diverse sample s to confirm their appropriateness for estimating quality -adjusted life-year in cancer-patient trials including only the QLQ-C30
target: RESULTS ( 1 ) EQ-5D was valid and responsive for skin conditions and most cancers ; in vision , its performance varied according to aetiology ; and performance was poor for hearing impairments .
  The HUI3 performed well for hearing and vision disorders .
  It also performed well in cancers although evidence was limited and there was no evidence in skin conditions .
  Response mapping using all the domain scores was the best performing model for the EORTC QLQ-C30 .
  In an exploratory analysis , a limited dependent variable mixture model performed better than an equivalent linear model .
  3 ) The exploratory valuation study found that bolt-on items for vision , hearing and tiredness had a significant impact on values of the health states , but the direction and magnitude of differences depended on the severity of the health state .
  The vision bolt-on item had a statistically significant impact on EQ-5D health state values and a full valuation model was estimated .
  EQ-5D performs well in studies of cancer and skin conditions .
  Mapping techniques provide a solution to predict EQ-5D values where EQ-5D has not been administered .
  For conditions where EQ-5D was found to be inappropriate , including some vision disorders and for hearing , bolt-ons provide a promising solution .
background: BACKGROUND The National Institute for Health and Care Excellence recommends the use of generic preference-based measures ( GPBMs ) of health for its Health Technology Assessment s ( HTAs ) .
  However , these data may not be available or appropriate for all health conditions .
  OBJECTIVES To determine whether GPBMs are appropriate for some key conditions and to explore alternative methods of utility estimation when data from GPBMs are unavailable or inappropriate .
  ( 2 ) Potential modelling approaches to ' map ' EQ-5D values from condition-specific and clinical measures of health [ European Organisation for Research and Treatment of Cancer Quality -of-life Question naire Core 30 ( EORTC QLQ-C30 ) and Functional Assessment of Cancer Therapy - General Scale ( FACT-G ) ] are compared for predictive ability and goodness of fit using two separate data sets . (