Health-related Quality Of Life Scores In Patients Research Articles

HRQOL after endoscopic transaxillary gasless hemithyroidectomy.

Endoscopic transaxillary gasless hemithyroidectomy (TAH) is one of several different hemithyroidectomy approaches. TAH has the advantage of better cosmesis compared to open surgery, although we have a lack of information about patient health-related quality of life (HRQOL) after TAH. To evaluate HRQOL after TAH. The prospective clinical study involved 40 patients who underwent TAH. Patient demographic and clinical data were collected. Patients completed the Short-Form 36 Health Survey (SF-36) before surgery, and at 1 and 6 months after surgery. Patients were followed up at an outpatient clinic for a check-up and postoperative evaluation. Patient HRQOL preoperative scores were compared with the general population. All patients were female, with a median age of 32 years and median body mass index of 23 kg/m2. The overall complication rate was 12.5%. According to the SF-36, patient HRQOL 1 month after TAH decreased in role physical (RP) and bodily pain (BP) scores (p < 0.05). RP and BP scores reached the preoperative level 6 months after surgery. Patients' role emotional score 6 months after surgery was higher than before surgery (78.94 ±34.16 vs. 93.38 ±19.24; p < 0.05). Role physical, general health, physical functioning and vitality scores were changed (p < 0.05) 1 month after surgery in patients with different pathological examination results, lobe weight, lobe volume and postoperative complications. Patient HRQOL scores are higher 6 months after TAH than before surgery. Thyroiditis in pathological examination, resected lobe weight and volume, postoperative complications have significance to postoperative HRQOL scores.

O14-4 Association of financial toxicity with quality-of-life in patients with gynecologic cancer

Financial Toxicity (FT) is one of the side effects of treatment which affects not only the patient's finances, but also treatment choice and adherence. Therefore, it is considered that FT can affect the patient's health related quality-of-life (HRQoL). We aimed to examine the correlation between FT and HRQoL scores in patients with gynecologic cancer.

MO1047: Patient Reported Outcomes in Glomerulonephritis

Abstract BACKGROUND AND AIMS Glomerulonephritis and its treatment may be associated with disease or treatment-related complications causing significant symptom burden and hospitalizations affecting physical function and quality of life (QoL). Patient-centered care harnessing patient-reported outcome measures (PROMs) can guide physicians to optimize patients’ functional well-being. Few studies have described health-related QoL (HRQOL) in patients with glomerulonephritis. We aimed to describe the HRQOL and determinants of HRQOL among patients with active glomerulonephritis. METHOD This was a cross-sectional study of adults with active glomerulonephritis recruited at the Singapore General Hospital Glomerulonephritis Disease Management Clinics between July 2020 and July 2021. HRQOL was assessed using the Short-Form Health Survey (SF-36) and Patient-Reported Outcome Measurement Informative System (PROMIS). Socio-demographic and clinical data were collected. Multivariate linear regression was used to determine predictors of HRQOL. RESULTS A total of 60 patients with glomerulonephritis (13 minimal change disease, 9 primary focal segmental glomerulosclerosis, 8 membranous nephropathy, 15 lupus nephritis, 8 IgA nephropathy and 7 other glomerulonephritis) with median age 44.5 years old (IQR 32–57) participated. Most (83%) had received immunosuppressants within 60 days of study enrolment. The scores for general health and energy were lower than other health domains of SF-36 such as physical functioning (Table 1). Health domain scores of those with nephrotic presentations (minimal change disease, FSGS and membranous nephropathy) and nephritic presentations (lupus nephritis and IgA nephropathy) were not significantly different. In the multivariable model accounting for age, gender, eGFR, ethnicity, hematuria, edema and immunosuppressant use (Table 2), age correlated positively with emotional role and social functioning while ethnicity influenced the pain scores. Hematuria was associated with lower physical role scores while eGFR correlated positively with social functioning. Calcineurin inhibitor use was associated with higher global physical health scores. CONCLUSION Sociodemographic, clinical and treatment may affect SF-36 and PROMIS HRQOL scores in patients with glomerulonephritis.

Prevalence and Characteristics of Spinal Sagittal Malalignment in Patients with Osteoporosis.

Spinal sagittal malalignment due to vertebral fractures (VFs) induces low back pain (LBP) in patients with osteoporosis. This study aimed to elucidate spinal sagittal malalignment prevalence based on VF number and patient characteristics in individuals with osteoporosis and spinal sagittal malalignment. Spinal sagittal alignment, and VF number were measured in 259 patients with osteoporosis. Spinal sagittal malalignment was defined according to the SRS-Schwab classification of adult spinal deformity. Spinal sagittal malalignment prevalence was evaluated based on VF number. In patients without VFs, bone mineral density, bone turnover markers, LBP scores and health-related quality of life (HRQoL) scores of normal and sagittal malalignment groups were compared. In 205 of the 259 (79.2%) patients, spinal sagittal malalignment was detected. Sagittal malalignment prevalence in patients with 0, 1, or ≥2 VFs was 72.1%, 86.0%, and 86.3%, respectively. All LBP scores and some subscale of HRQoL scores in patients without VFs were significantly worse for the sagittal malalignment group than the normal alignment group (p < 0.05). The majority of patients with osteoporosis had spinal sagittal malalignment, including ≥70% of patients without VFs. Patients with spinal sagittal malalignment reported worse LBP and HRQoL. These findings suggest that spinal sagittal malalignment is a risk factor for LBP and poor HRQoL in patients with osteoporosis.

Health-related quality of life before and during chemotherapy in patients with early-stage breast cancer.

ObjectivesIdentify the main changes in the health-related quality of life (HRQoL) of women diagnosed with breast cancer (BC) undergoing chemotherapy.MethodsProspective cohort study that included 33 women diagnosed with clinical stages I–III BC and who underwent adjuvant chemotherapy. HRQoL was assessed using the EORTC QLQ-C30 and EORTC QLQ-BR23 instruments 1 week before the start of chemotherapy and during the third month of chemotherapy.ResultsThere was a decline in the HRQoL scores of patients during treatment. Therefore, chemotherapy alters the patient’s perceptions of their HRQoL since there is a decrease in global health status/quality of life (QoL) and functional scales such as physical functioning, role functioning, emotional functioning, social functioning, body image, sexual function and sexual enjoyment. We also observed an increase in side effects related to the systemic therapy, fatigue, nausea and vomiting, insomnia, appetite loss and diarrhoea, despite a decrease in breast symptoms and arm symptoms.ConclusionsHRQoL was negatively affected during chemotherapy. Even though HRQoL assessment is a useful method for optimising patients’ care, its implementation into clinical practice remains a challenge. Since side effects are very often underestimated, we consider that the evaluation of HRQoL parameters should be done for BC patients treated with chemotherapy.

Evaluation of health-related quality of life and affecting factors in child with enuresis

Enuresis is a common problem in children and distressing condition that can have an impact on the child's behavior and on their emotional and social life. Health-related quality of life (HRQoL) is defined as an individual's perception of the impact of the disease and treatment. The aim of this study was to evaluate the HRQoL in Turkish children with enuresis and to investigate the effect of independent sociodemographic and clinical variables on HRQoL in children with enuresis. 110 children with enuresis and their mothers and 120 healthy children and their mothers were included in the study. The German quality of life questionnaire (KINDL®) scales were used to assess the children's HRQoL. For comparing the data of children with enuresis and healthy children, a two-sided unpaired t-test and linear regression model were used. The total HRQoL score for the children with enuresis group was 63.14±21.98 and for the children in the control group was 75.6±10.1 (P<0.001). After adjusting for sex and age using the unstandardized coefficient of regression model, HRQoL score for the children with enuresis still remained statistically significant lower than that for healthy peers (64.21± vs 75.11± P<0.001). The HRQoL subscale scores showed that children with enuresis had lower emotional well-being scores (64.23±14.2 vs 78.9±11.4, P<0.001), self-esteem score (62.23±11 vs 68.6±17.4, P=0.001), family relationship score (76.23±2 vs 83.4±12.2, P=0.042), and friendship score (62.4±13.2 vs 68.8±15.3, P=0.023) compared to the control group. When the effects of independent sociodemographic factors and clinical variables on HRQoL were evaluated, it was seen that the presence of lower urinary tract symptoms (LUTS) negatively affected total HRQoL score (59.89±11.2 vs 69.29±10.9 P=0.028). Also the total HRQoL score was higher in treated children with enuresis than in nontreated children (65.96±12.1 vs 55.27±10.1 P=0.032). Among the treated children, complete treatment response group had higher total HRQoL score compared to partial treatment response group and nonresponse group (respectively, 70.98±9.7, 65.25±10.1, 60.45±10.9, P=0.034, P=0.01) (Summary Figure). Family income level affected total HRQoL score, low-income group had lower total HRQoL score compared to high-income group (62.17±11.9 vs 69.25±10 P=0.039). This study demonstrated that enuresis negatively affects the HRQoL of children and most affected domains in HRQoL were self-esteem, emotional well-being, and their relationship for family and friends. Our presented study showed that HRQoL was lower in non-primary monosymptomatic nocturnal enuresis (non-PMNE) children, nontreated patients. Also there were higher HRQoL scores in patients who had a total or partial response to treatment. Our study may indicate that, low-income children with enuresis, nontreated enuretic children, and presence of LUTS should be considered as a risk group for low HRQoL.

Patients With Nonalcoholic Steatohepatitis Experience Severe Impairment of Health-Related Quality of Life

Although there is substantial evidence suggesting poor health-related quality of life (HRQL) in patients with chronic hepatitis C (CHC), similar data in nonalcoholic steatohepatitis (NASH) have not been fully assessed. The aim is to compare HRQL scores in patients with CHC to those with NASH. Matched patients with advanced fibrosis (bridging fibrosis and compensated cirrhosis) due to CHC and NASH completed Short Form-36 (SF-36) questionnaire, Chronic Liver Disease Questionnaire (CLDQ), and Work Productivity and Activity Instrument questionnaire. We included 1,338 patients with NASH with advanced fibrosis (mean age 57.2 years, 47% men, 55% cirrhosis) and 1,338 matched patients with CHC. Patients with CHC and NASH had similar rates of employment and psychiatric disorders (P > 0.05). As expected, patients with NASH had higher body mass index (mean 33.7 vs 27.6) and more type 2 diabetes (74% vs 16%) (all P < 0.01). Patients with NASH had significantly lower HRQL scores related to physical health: Physical Functioning, Bodily Pain, General Health, Vitality, Physical Summary of SF-36, and Fatigue of CLDQ (P < 0.02). By contrast, patients with CHC had a lower Mental Health score of SF-36 and Emotional score of CLDQ and reported greater impairment in daily activities as measured by the Work Productivity and Activity Instrument questionnaire (P < 0.002). In multivariate analysis, after adjustment for demographic parameters, cirrhosis, and history of psychiatric disorders, having NASH was associated with lower physical HRQL scores and higher mental health-related scores (P < 0.05). Patients with NASH and advanced fibrosis have more impairment of their physical health-related scores than patients with CHC with advanced fibrosis. These data should dispel the misconception that NASH is an asymptomatic disease with little negative impact on patients' well-being.

Is the Hospital Anxiety and Depression Scale Associated With Outcomes After Lumbar Spine Surgery?

Study Design:Longitudinal cohort.Objectives:The Hospital Anxiety and Depression Scale (HADS) was developed to provide clinicians a reliable, valid, and practical tool to identify and quantify the anxiety and depression in medical patients. Several studies have shown that patients with chronic low back pain may have subclinical depression and impairments in mental health and that these in turn may lead to less than optimal results after lumbar spine surgery. The purpose of this study is to determine if there are associations between preoperative HADS and differences in pre- and postoperative health-related quality-of-life (HRQOLs) scores after spine surgery.Methods:From a single center, a consecutive series of patients completed the HADS, Oswestry Disability Index (ODI), Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and Visual Analog Scale (VAS) for back and leg pain. Except for HADS, the patients completed the same HRQOLs 1 year after surgery.Results:Of 308 eligible cases, 208 (68%) had follow-up data available and were included in the analysis. Patients in the HADS-Anxiety (HADS-A) Abnormal category had the worst preoperative HRQOLs but had the greatest improvement in 1-year postoperative scores. Except for VAS Leg Pain, preoperative HRQOLs were better in patients in the HADS-Depressed (HADS-D) Normal category. Patients in the HADS-D Abnormal category had statistically significantly greater improvement in 1-year postoperative EQ-5D and ODI scores when compared with the other cohorts.Conclusion:Worse HADS-A and HADS-D scores are associated with worse preoperative HRQOL scores in patients with lumbar degenerative disorders scheduled for spine surgery. However, similar improvements in HRQOLs can be expected 1 year postoperative regardless of the patients’ HADS scores.

Sustained Improvements in Fatigue and Quality of Life in Iron Deficiency Anemia Patients Following a Single Course of Ferumoxytol: Results of a 6-Month Extension Study

Introduction: Iron is essential for the function of many key proteins including hemoglobin (Hgb) and myoglobin (involved in oxygen transport/exchange), cytochromes (involved in energy generation), various enzymes (involved in cell proliferation and neurotransmission), and immune function. Iron deficiency can, therefore, negatively impact patients' health-related quality of life (HRQOL) and requires treatment to replete iron stores. Although oral iron is a common initial treatment, some patients do not tolerate it or fail to adequately respond, and many of these patients live with chronic anemia and the related negative effects on their HRQOL. A Phase 3 double-blind, placebo-controlled trial (NCT01114139) had previously found that patients with iron deficiency anemia (IDA), unsuccessfully treated with oral iron, had very poor baseline HRQOL scores associated with fatigue, and that IV iron treatment with ferumoxytol resulted in clinically meaningful improvements, significantly greater than placebo, over the 5-week study period. To explore the durability of this treatment effect, this analysis reports on the impact on patient-reported outcomes (PRO) of a single course of ferumoxytol therapy over the course of the subsequent 6-month extension study.Methods: A 6-month Phase 3, open-label extension study (NCT01114217) was conducted in patients who had completed the double-blind, placebo-controlled Phase 3 trial. Enrolled patients were evaluated for IDA monthly throughout the study period. Those with persistent or recurrent IDA (Hgb <11.0 g/dL and TSAT <20%) at any evaluation visit, received a course of ferumoxytol (2 x 510 mg, 3-8 days apart). The same validated PRO instruments were administered in this extension study as in the preceding double-blind trial: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue), Short Form Health Survey (SF-36), and Linear Analogue Scale Assessment (LASA) of Energy, Activities of Daily Living (ADL) and HRQOL. This analysis reports results for the subgroup of patients who did not receive any additional doses of ferumoxytol during the entire 6-month period of the extension study.Results: The majority of patients enrolled in the extension study who had received ferumoxytol in the previous Phase 3 trial (285/471; 61%) did not meet the above-noted re-treatment criteria during the 6-month extension, and did not receive any further doses of ferumoxytol. Reflecting the overall enrollment in the extension study, these patients were predominantly female (90.0%) and white (63.5%), with mean age of 43.6±13.3 years (range 19-88). The most common primary underlying conditions were abnormal uterine bleeding (41.8%), GI disorder (33.0%), and cancer (10%). Their mean Hgb had increased from 9.0±0.8 g/dL at Baseline to 12.1±1.1 at Week 5 of the double-blind trial and remained above 12.0 throughout the 6-month extension study visits (Month 7 Hgb 12.1±1.2) despite receiving no further ferumoxytol.At Baseline of the double-blind trial, their FACIT-Fatigue scores were lower (24.3±12.3) than general (non-anemic) US population norms (40.1-43.6), and comparable to anemic cancer patients receiving chemotherapy (23.9, Cella 2002). By Week 5 following ferumoxytol treatment, their FACIT-Fatigue scores had increased significantly (36.1±11.2), approaching general population norms. This improvement was sustained over the following 6 months (Month 7 score 38.8±11.5).Their SF-36 Vitality scores increased from 37.6 ±11.8 at Baseline of the double-blind trial to 47.7±12.0 at Week 5, approaching the general US population norm (50.0, McHorney 1993) and continued to increase slightly over the next 6 months (Month 4, 50.0±12.0; Month 7, 50.9±11.5). Similarly, the significant improvements in LASA Energy, ADL and HRQOL scores that were observed in the double-blind study were also maintained over the next 6 months.Conclusions:These data suggest that ferumoxytol may provide important clinical benefits to IDA patients with a history of unsatisfactory oral iron therapy; these benefits include reductions in fatigue, increased energy, vitality, and ability to perform ADL and improved HRQOL. This is important especially in light of the poor baseline energy and HRQOL scores of patients who cannot take oral iron. This study found that for the majority of patients, these improvements were sustained for at least 6 months after a single course of therapy. [Display omitted] DisclosuresVadhan-Raj:AMAG Pharmaceuticals, Inc: Other: received funding from Amag to support clinical trial. Dahl:AMAG Pharmaceuticals, Inc: Employment, Equity Ownership. Jiang:AMAG Pharmaceuticals, Inc: Employment, Equity Ownership. Strauss:AMAG Pharmaceuticals, Inc: Employment, Equity Ownership.

Different rhinologic diseases cause a similar multidimensional decrease in generic health-related quality of life.

Previous studies illustrated that chronic rhinosinusitis and allergic rhinitis represent individual and socioeconomic burdens to a patient. However, few studies exist on the health-related quality of life (HRQoL) amongst other rhinologic patients. Our study investigated the generic HRQoL in different rhinologic diseases. Unselected adult rhinologic patients requiring special care at the Helsinki University Hospital were enrolled in this cross-sectional, questionnaire-based prospective study in February, May, August and November 2014. Patients were mailed a medical history questionnaire and a generic 15-dimension (15D) HRQoL questionnaire. Diagnostic data were collected from electronic patient records following outpatient visits. Patient HRQoL scores were compared to an age- and sex-standardised general population sample obtained from a large national health examination survey. This study consisted of 337 rhinologic patients (mean age 50.2years, 50.4% men). The mean 15D score amongst rhinologic patients (0.865) was both statistically significant and clinically poorer than that amongst the general population (0.929). Rhinologic patients fared poorly on most dimensions of the 15D instrument, particularly on sleep, discomfort and symptoms, breathing and vitality. Patients with obstructive sleep apnoea (OSA) were particularly affected. Yet, comparing the five most common rhinologic diagnostic groups revealed no significant differences in the mean 15D scores. Rhinologic diseases, independent of the underlying cause, substantially and negatively affect patients' HRQoL. OSA decreases HRQoL in these patients, although patients without an OSA diagnosis still suffer from a clinically important impairment of HRQoL and poor quality sleep.

Diabetes prevalence and its impact on health-related quality of life in tuberculosis patients.

To determine the prevalence of diabetes mellitus (DM), assess its influence on health-related quality of life (HRQoL) among patients with TB. In this prospective study, eligible patients at three primary healthcare centres in urban slum region of south Delhi, India, underwent blood glucose screening at treatment initiation. HRQoL scores were determined by conducting face-to-face interviews using Dhingra and Rajpal (DR-12) scale at pre-treatment, end of intensive phase and end of the treatment. In 316 patients, the overall DM prevalence was 15.8%, of whom 9.5% were known to have diabetes, and 6.3% were diagnosed at TB treatment initiation. DM was more common among patients of older age (P < 0.001), with higher BMI (P < 0.001), with PTB (P = 0.02) and with poor psychological status. HRQoL was significantly poor in the socio-psychological & exercise adaptation domain in patients with DM ˃50 years of age at each visit. Older age, poor literacy, loss in workdays, alcohol use and socio-economic status significantly predict poor HRQoL scores in patients with DM. Uncontrolled DM patients demonstrated poor HRQoL at the end of the intensive phase (P = 0.04) of treatment and at its completion (P = 0.03) compared to those with controlled DM. Addressing screening measures and glycaemic control along with social determinants such as literacy level and alcohol consumption could be an important means of improving the HRQoL of TB with DM patients.

The Likelihood of Reaching Substantial Clinical Benefit After an Interlaminar Dynamic Spacer for Chronic Low Back Pain: A Clinical and Radiologic Analysis of a Prospective Cohort.

Chronic low back pain (CLBP) often causes disabling pain that impairs a patient's quality of life. Surgical treatment is recommended for patients who do not respond to conservative treatments lasting more than 6 months. The purpose of this study is to present results after the use of an interlaminar dynamic spacer for CLBP. We enrolled consecutive patients with CLBP irresponsive to more than 6 months of conservative treatment into the present study. Included patients underwent an interlaminar dynamic spacer insertion without direct decompression. We assessed radiographic parameters and health-related quality of life (HRQoL) data included visual analog scale back/leg pain and Oswestry Disability Index scores. Substantial clinical benefit achievement was assessed. Thirty-five patients (average age, 47.8 years; 21 female) were included. The mean preoperative symptom duration was 29.6 months. Surgeries involved 1-level (n=18) and 2-levels (n= 17) procedures. Operative levels included L4-5 (n= 8), L5-S1 (n= 10), L3-4-5 (n-2), and L4-5-S1 (n= 15). The average follow-up period was 16.6 months. After the procedure, all radiographic parameters (including disc height, segmental extension angle, and foraminal area) improved significantly. All preoperative HRQoL parameters improved significantly at the final follow-up. Substantial clinical benefit achievement was observed in 75.8% of the cases on the Oswestry Disability Index, and in 72.7% and 84.8% of the cases on the visual analog scale back and leg pain, respectively. An interlaminar dynamic spacer significantly improves HRQoL scores in patients with CLBP who do not respond to conservative treatment. Although encouraging, these results should be confirmed with studies assessing a larger cohort and a longer follow-up.

Self-reported health-related quality of life predicts 5-year mortality and hospital readmissions in patients with ischaemic heart disease.

Patient health-related quality of life (HRQL) is an important health outcome with lower HRQL associated with adverse events in patients with ischaemic heart disease (IHD). Baseline health-related quality of life was investigated as a predictor of 5-year all-cause mortality and cardiac readmissions in Danish patients with IHD. The international HeartQoL Project survey was designed to develop a core HRQL questionnaire for patients with IHD. Baseline scores on each of the 14 items ultimately included in the HeartQoL questionnaire were linked to Danish national health registries and hazard ratios for mortality and readmissions were estimated using Cox regression models. Among 938 eligible Danish patients with IHD, 662 (70.6%) participated in the international HeartQoL Project. During the 5-year follow-up, 83 patients died and 196 patients were readmitted. Adjusted analyses showed a significant linear association between all-cause mortality and both lower global HRQL (HR = 1.67, 95% CI: 1.26-2.23; p<0.001) and physical scores (HR=1.71, 1.33-2.21; p<0.001) and between readmission and both lower global (HR=1.73, 1.41-2.12; p < 0.001) and physical scores (HR = 1.63, 1.35-1.96; p < 0.001). A significant, but non-linear, effect was found for emotional HRQL score on outcomes. This study shows a significant and linear relationship between lower global and physical HRQL scores in patients with IHD and 5-year all-cause mortality and cardiac readmission.

Changes in health-related quality of life (HRQL) after bladder cancer (BC) diagnosis (DX): A longitudinal population-based study.

317 Background: Few studies have examined longitudinal changes in HRQL among BC patients. To our knowledge, this is the largest prospective population-based study to quantify HRQL changes from before to after BC DX and to compare their HRQL with a non-cancer cohort. Methods: Our sample included 179 BC patients (≥ age 65) and 376,986 non-cancer subjects within the SEER-Medicare Health Outcomes Survey database (1998-2007). We assessed HRQL as measured by physical (PCS) and mental (MCS) component summary scores of the veterans RAND 12-item health survey. An analysis of covariance model was used to estimate changes in HRQL scores for patients after BC DX relative to control subjects with adjustment for baseline HRQL scores and covariates. Results: 84.4% (N=151) of BC patients had non-muscle invasive BC (NMIBC) and 15.6% (N=28) had muscle invasive BC (MIBC). 49.2% and 39.1% of BC patients had ≥2 comorbid conditions and ≥1 activities of daily living (ADL) deficit, respectively. Compared to the control subjects, more BC patients were men (67.0% vs 38.5%; P&lt;0.01), current or former smokers (58.7% vs 37.3%; P&lt;0.01), and had income ≥ $50,000(15.1% vs 8.8%; P=0.02). Other baseline demographic and socioeconomic characteristics were similar (P&gt;0.05). After DX, BC patients reported a significant decline in PCS (1.9; 95% CI 0.1, 3.7) score compared to non-cancer controls whereas the decrease in MCS score (1.4; 95% CI -0.1, 3.0) was not statistically significant. For those with NMIBC, HRQL was not significantly different than that of the non-cancer cohort (P&gt;0.05) after DX. However, the PCS and MCS scores of MIBC patients decreased by 5.3 (95% CI 0.9, 9.8) and 3.8 points (95% CI -0.1, 7.7) after DX, respectively. Older age at BC DX, lower educational and income levels, smoking history, and higher numbers of comorbid conditions and ADL deficits were significantly associated with inferior PCS and MCS scores after BC DX (P&lt;0.01). Conclusions: Treatment-related side effects and/or symptoms due to BC adversely affect HRQL of BC patients, especially in those with MIBC, and should be consistently assessed by health care providers. Future research that examines interventions to improve HRQL is critical to improve BC care.

Commentary on Jäghult S, Saboonchi F, Johansson U, Wredling R and Kapraali M (2011) Identifying predictors of low health‐related quality of life among patients with inflammatory bowel disease: comparison between Crohn's disease and ulcerative colitis with disease duration. Journal of Clinical Nursing 20, 1578–1587

Crohn's disease and ulcerative colitis (UC) are two of the most common chronic inflammatory bowel diseases (IBD) affecting approximately 240,000 people in the UK (IBD Standards Group 2009). Worldwide, incidence rates are reported to be highest in northern Europe and America (Jäghult et al. 2011) with severe symptoms affecting sufferers of all ages and which include rectal bleeding, abdominal pain and diarrhoea. The consequence of repeated severe relapses is profound in terms of the impact on quality of life, continuity of education and the ability to work. Jäghult et al. (2011) provide an insight into health-related quality of life (HRQOL) using four quality-of-life instruments in a sample of Swedish patients diagnosed with IBD for differing lengths of time. The study is of international importance as in identifying which patients perceive their quality of life to be lowest, healthcare specialists can direct resources to provide greatest support at the point of greatest need. The authors conclude that patients with Crohn's disease have lower HRQOL scores than those with UC, and those more recently diagnosed are more likely to report lower scores than those with disease of longer duration (Jäghult et al. 2011). Interestingly, the study compares HRQOL scores in patients receiving their diagnosis within two years and over five years, both periods of time being within the relatively early stages of disease management. Throughout both periods of time, a range of treatment options are likely to be tried to provide optimum relief from symptoms, which frequently vary markedly within individuals. The results convey an important message for service delivery, that is, newly diagnosed patients require greater support than those who may have lived with the condition long enough to come to terms with the disease and achieved some degree of control of symptoms through interventions. It would be interesting to see how HRQOL changes over time throughout the lifespan. It is recognised that IBD presentation often occurs at a young age, with symptoms flaring throughout life (Carter et al. 2004) and treated with a variety of treatment options including corticosteroids and immunosuppressive drugs, through to surgery for disease not responding to medical interventions. The value of the emerging role of the IBD nurse specialist role is recognised by the UK IBD Standards Group (2009). The complexity of interventions delivered by IBD specialist nurses is described by Hall (2011) as including clinics for advice, early access for relapses and long-term care, and telephone help lines. The IBD nurse specialist is ideally placed to respond to the needs of the newly diagnosed patient to promote understanding of the disease, acceptance of lifestyle changes and self-management of symptoms to improve quality of life. Taylor et al. (2008) believe the phrase ‘quality of life’ although commonly used, has no single definition but includes sociological, economical, psychological, philosophical and ethical elements of a person's experience of living with the disease and receiving treatment. Their study led them to add the need to consider developmental stage, use of language and an individual's concept of health in young people with chronic disease (Taylor et al. 2008). The evidence presented by the study of Jäghult et al. (2011) contributes to understanding the necessity to provide support additional to that of managing the disease process in the early stages following diagnosis of the IBD patient and affirms the need to recognise the value of the IBD nurse specialist in this role.

Assessment and comparison of health-related quality-of-life (HRQOL) in patients with epilepsy in India

Seizure frequency, medical and psychiatric morbidities, number and nature of antiepileptic drugs, and medication side effects have been correlated with decreased HRQOL scores in patients with epilepsy. Quality of Life in Epilepsy-31 patient inventory was translated and validated in two regional languages and administered to 80 patients with epilepsy who were on first-line antiepileptic drugs and classified as responders and nonresponders. The outcomes were measured based on 7 domains, such as seizure worry, overall QOL, emotional well-being, and energy/fatigue and based on the overall score of the scale. For both translations, Cronbach's alpha (coefficient) was greater than 0.70 [except for the seizure worry scale (0.69) in the Hindi questionnaire]. There was statistical difference (p<0.0001) of HRQOL scores between responders and nonresponders of epilepsy. The HRQOL score was lower in nonresponders. The most affected domain was emotional well-being in both groups, and the least affected domains were energy/fatigue in responders and medication effect in nonresponders.

Ferumoxytol Treatment Demonstrates Significant Improvements in Fatigue and Health-Related Quality of Life in Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy

AbstractAbstract 478 Introduction:Iron is essential for the function of many key proteins including hemoglobin (Hgb) and myoglobin (involved in oxygen transport/exchange), cytochromes (involved in energy generation), various enzymes (involved in cell proliferation and neurotransmission), and immune function. Iron deficiency can, therefore, negatively impact patients' health-related quality of life (HRQL) and requires treatment to replete iron stores. Although oral iron is a common initial treatment, some patients do not tolerate it or fail to adequately respond; many of these patients, therefore, live with chronic anemia and the related negative effects on their overall HRQL. Ferumoxytol (FER) is a new IV iron indicated for the treatment of Iron Deficiency Anemia (IDA) in patients with chronic kidney disease (CKD). FER is being investigated to treat IDA patients without CKD who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. To prospectively explore the impact of FER treatment on patient reported outcomes (PROs), the Phase 3 clinical trials included: the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue); the Short Form Health Survey (SF-36); and the Linear Analogue Scale Assessment (LASA) of Energy, Activities of Daily Living (ADL) and HRQL. Methods:IDA patients with Hgb <10.0 g/dL and >7 g/dL, and transferrin saturation (TSAT) <20% were eligible. Eight hundred-eight subjects were randomized 3:1 to receive either 2 injections of 510 mg of FER administered 5±3 days apart or IV normal saline (placebo). FACIT-Fatigue assessments were done pre-dose at Baseline and weekly up to Week 5; the SF-36 and LASA were administered at Baseline, Week 3 and Week 5. Comparison of the mean change in FACIT-Fatigue scores from Baseline to Week 5 was a pre-specified secondary endpoint; mean change in the SF-36 Vitality Domain and LASA scores were exploratory endpoints. Results:At Baseline, FACIT-Fatigue scores for both treatment groups were lower (FER, 24.0 ±11.8; placebo, 24.7 ±11.3) than general (non-anemic) US population norms (40.1), and comparable to anemic cancer patients receiving chemotherapy (23.9). FER-treated subjects showed a robust 2.7 g/dL increase in mean Hgb from Baseline to Week 5, compared to only a 0.1 g/dL increase with placebo (p<0.0001). Paralleling this Hgb increase, FER-treated subjects also demonstrated large improvements in FACIT-Fatigue scores at each time point with significant improvement as early as Week 1 (+7 point change). Further improvements in fatigue were seen at weeks 2, 3, and 4 after FER treatment, and by Week 5, FACIT-Fatigues scores had increased over 12 points (36.8±11.2) and approached general population norms (40.1). In contrast, FACIT-Fatigue scores in placebo-treated subjects showed a lower increase at Week 1 and no further increase at subsequent time points. At all post-treatment time points, the FACIT-Fatigue score increases in FER-treated subjects were statistically significantly higher than placebo-treated subjects. FER-treated subjects demonstrated significantly greater improvements in SF-36 Vitality scores at each time point following FER treatment relative to placebo. In addition, significantly greater improvements in LASA Energy, ADL and HRQL scores were observed at each time point compared to placebo; these improvements continued to increase for FER at Week 5, but decreased for placebo.Mean Change in FACIT-Fatigue Scores [Display omitted] Mean Change* in SF-36 Vitality ScoresVisitFerumoxytol N = 608Placebo N = 200p-valueWeek 39.65.90.0002Week 510.65.4<0.0001Mean Change* in LASA ScoresEnergyWeek 310.94.00.0011Week 515.96.5<0.001Activities of Daily LivingWeek 37.92.40.0106Week 511.93.60.0003Quality of LifeWeek 38.62.60.0051Week 512.84.10.0001*Least Square Mean. Conclusions:These data suggest that FER may provide important clinical benefits to IDA patients with a history of unsatisfactory oral iron therapy; these benefits include reductions in fatigue, increased energy, vitality, and ability to perform ADL and improved HRQL. This is important especially in light of the poor baseline energy and HRQL scores of patients who cannot take oral iron. FER could, therefore, provide an important, new treatment option for IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. Disclosures:Vadhan Raj:AMAG Pharmaceuticals, Inc.: Research Funding. Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Hsieh:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Stevenson:AMAG Pharmaceuticals, Inc.: Employment. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

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

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

The evaluation of health-related quality of life in patients with inflammatory bowel disease

Objective To investigate the health-related quality of life (HRQoL) and its influencing factors in patients with inflammatory bowel disease (IBD).Methods The IBD patients underwent cross-sectional survey through Chinese version of inflammatory bowel disease questionnaire (C-IBDQ),the HRQoL of IBD patients were evaluated and analyzed with correlation analysis and multiple-linear regression analysis.Results A total of 100 IBD patients finished the questionnaire (UC 80,CD 17,ID 3).The overall score of HRQoL in IBD patients were (175.9±37.9),score of each item decreased,especially in the aspect of emotional function. There was no significantly difference in total scores of HRQoL between UC patients and DC patients (P＞0.05).The HRQoL total scores and each item score of patients in active period were significantly lower than those in remission period (149.4 ± 35.2,195.1 ± 26.7 ; P＜0.05).The HRQoL scores of patients with the duration less than one year were significantly lower than those over one year (P＜0.05).The HRQoL scores of severe patients were significantly lower than those of mild patients (P＜0.05).The HRQoL scores of patients whose medical cost mainly paid by themselves were lower than those paid by medical insurance,there were significant differences in social function and economic burden between these two groups.Multiple linear regressions analysis indicated that the influential factors of HRQoL were disease severity and activity,duration,and the payment.Conclusions The HRQoL of IBD patients are impaired in varying degrees.The influential factors of HRQoL were disease severity and activity,duration,and the payment.The HRQoL of IBD patients is obviously affected by economic burden. Key words: Inflammatory bowel diseases; Quality of life; Fees, medical

Coping style and health-related quality of life in caregivers of epilepsy patients.

Epilepsy has a significant impact on health-related quality of life (HRQOL) of patients and personal coping style is an important determinant. Less is known about home caregivers. This study investigates HRQOL and coping style of both patients and caregivers and their interaction. Epilepsy patients attending the outpatient clinic of the University Medical Centre in Utrecht and their caregivers were sent EQ5D and RAND-36 questionnaires. The Utrecht Coping List was used to chart personal coping styles. HRQOL scores of patients and caregivers were compared to the general Dutch population. The association between patient and caregiver HRQOL scores was calculated. A stepwise backward multivariate linear regression analysis was used to explain variances in caregiver HRQOL. Eighty-six couples (49%) returned all questionnaires. Caregiver HRQOL scores were comparable to the general Dutch population (EQ5D: 0.88–0.88; p = 0.90, RAND-36 MCS: −2 points; p = 0.16), while patients HRQOL scores were lower (EQ5D: 0.79; p < 0.01, RAND-36 MCS −10 points; p < 0.01). However, on several specific domains, associations between patient and caregiver HRQOL scores within couples were found. Passive coping style explained 50% of variation in HRQOL scores of caregivers. As a group, caregivers of epilepsy patients have normal HRQOL, but there are significant associations between patient and caregiver HRQOL scores. Improving caregiver HRQOL through interventions on coping style might benefit patients as well. Recognizing personal coping styles of both patient and caregiver should be part of a patient-oriented approach in treatment.