Longitudinal Changes In Health-related Quality Research Articles

Long-term effect of increasing water intake on repeated self-assessed health-related quality of life (HRQoL) in autosomal dominant polycystic kidney disease.

The aim of this study was to determine the long-term effect of increasing water intake in patients with autosomal dominant polycystic kidney disease (ADPKD) on longitudinal changes in health-related quality of life (HRQoL) in the setting of a clinical trial. Self-completed HRQoL (using the KDQoL-SF, v.1.3 questionnaire) was assessed annually in participants of a 3-year randomized controlled clinical trial (n=187), allocated (1:1) either to increase water intake to reduce urine osmolality to ≤270 mosmol/kg (implemented by dietetic coaching, self-monitoring tools, text messaging) or continue usual water intake. Overall, 96% and 81.8% of participants (n=187) completed the questionnaire at the baseline and final study visits, respectively. At baseline, the physical component summary score (PCS) and mental component summary score (MCS) were similar in the two groups (P>0.05) and the five dimensions with the lowest scores in both groups were: energy and fatigue; general and overall health; sleep; emotional well-being; and pain. Within each group, there were no longitudinal changes over time. At the final visit, the PCS was higher in the increased water intake group (51.3±7.6, mean±standard deviation) compared to the usual water intake group 48.8±9.3; P=0.037) whereas the MCS was numerically similar. The improvement in the PCS was due to higher sub-scale values for physical functioning and pain (both P<0.05). By multivariate analysis, only baseline PCS and height-corrected total kidney volume were associated with the final PCS (P<0.05). HRQoL scores remained stable over a 3 year period, and were not adversely affected by the intervention to increase water intake. Future studies should evaluate the clinical significance of the higher PCS in the increased water intake group.

Longitudinal health outcomes in caregivers of military members with traumatic brain injury.

To examine longitudinal change in health-related quality of life (HRQOL) in caregivers of service members/veterans with traumatic brain injury and factors associated with clinically elevated symptoms. Caregivers (N = 220) completed nine HRQOL outcome measures and 10 risk factor measures at a baseline evaluation and follow-up evaluation 3 years later. Caregiver's responses on the nine HRQOL outcome measures were classified into four clinical change categories based on the presence/absence of clinically elevated T-scores (≥ 60 T) at baseline and follow-up: (a) Persistent (baseline ≥ 60T + follow-up ≥ 60 T), (b) Developed (baseline < 60 T + follow-up ≥ 60 T), (c) Improved (baseline ≥ 60 T + follow-up < 60 T), and (d) Asymptomatic (baseline < 60 T + follow-up < 60 T). A clinical change composite score was calculated by summing the number of Persistent or Developed HRQOL outcome measures and used to create three clinical change groups: (a) No Symptoms (n = 69, zero measures), (b) Some Symptoms (n = 88, one to three measures), and (c) Numerous Symptoms (n = 63, four to nine measures). Of the nine HRQOL outcome measures, Bodily Pain, Perceived Stress, Sleep-Related Impairment, and Fatigue were most frequently classified as Persistent or Developed from baseline to follow-up in the entire sample. A linear relationship was found between the vast majority of risk factors across the three clinical change groups at baseline and follow-up (Numerous > Some > None). The risk factors were correlated with the number of elevated HRQOL symptoms at baseline and follow-up. Most Asymptomatic or Persistent caregivers did not have meaningful change (≥ 1 SD) in HRQOL scores. A sizable proportion of Developed or Improved caregivers had either meaningful or no change in HRQOL scores. There is a need for ongoing clinical services for military caregivers. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Association between atrial fibrillation and heart failure patient reported outcomes across the ejection fraction spectrum

BackgroundAtrial fibrillation (AF) is common in patients with heart failure (HF) and is associated with worse clinical outcomes. We evaluated the relationship between AF and longitudinal changes in health-related quality of life (HRQoL) measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) in both HF with preserved (HFpEF) and reduced ejection fraction (HFrEF). MethodsThis is a post-hoc analysis of the TOPCAT and HF-ACTION trials. The effect of AF on KCCQ overall summary scores (OSS), in both trials, was examined using a mixed effects regression model. Patients were divided into 3 groups according to AF status at baseline: patients with a history of AF but no AF detected on ECG at enrollment (Hx AF group), patients with history of AF and AF detected on ECG at enrollment (ECG AF group) and patients with post-randomization new-onset AF (New AF group). ResultsIn TOPCAT, among 1710 patients with KCCQ data available, AF was associated with a significantly lower KCCQ-OSS (-3.98; 95% CI -7.21: -0.74) at 48 months, with a significant AF status by time interaction (p=0.03). In HF-ACTION, among 1814 patients with available KCCQ data, AF was associated with a significantly lower KCCQ-OSS (-3.67; 95% CI -6.21: -1.41) at 24 months but there was no significant AF status by time interaction. In both trials, the type of AF was not associated with significant changes in KCCQ-OSS score. ConclusionΙn patients with both HFpEF and HFrEF, AF was independently associated with worse HRQoL measured by KCCQ.

Longitudinal Associations Between Multimorbidities and Patient-Reported Quality of Life.

The global prevalence of multimorbidity is increasing as the population ages. As individuals get older, they are likely to develop multiple chronic conditions, and nearly two-thirds of older adults in the United States are estimated to experience 2 or more chronic conditions. The present preregistered study examined whether multimorbidity was associated with longitudinal changes in health-related quality of life (i.e., anxiety, depression, and physical function) and whether these associations were moderated by sociodemographic factors (i.e., sex, race, marital status, income, insurance, and education). Data come from the Health Literacy and Cognitive Function Among Older Adults Longitudinal Study (LitCog), a prospective cohort study of English-speaking older adults (N = 900). At each measurement occasion, participants reported anxiety, depression, and physical function using the Patient Reported Outcomes Information System, chronic conditions, and sociodemographic characteristics. We employed multilevel growth models to estimate changes in health-related quality of life, with multimorbidities as a predictor and sociodemographics as covariates. Results indicated that individuals with multiple chronic conditions reported persistently high levels of anxiety and depression, and worse physical function. We found evidence for racial health disparities, such that individuals who identified as non-White experienced worse health-related quality of life as multimorbidities increased, relative to White participants. These results contribute to the current conversation about the long-term impacts of structural and systemic barriers experienced by minoritized groups. We further discuss the public health implications of multimorbidity in older adulthood.

Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma (ODYSSEY RCC).

TPS739 Background: The landscape for treatment of metastatic renal cell carcinoma (mRCC) has changed dramatically over the past 7 years with the approvals of tyrosine kinase inhibitors and immune-oncology (IO) agents alone or in combination for untreated mRCC. However, multiple knowledge gaps remain. While active surveillance remains an option for selected pts, prospective evidence on selection of and outcomes for pts is limited. Recent phase III trials all used a common comparator, sunitinib, so no comparative effectiveness data on the new IO-based regimens exists. There are also no routinely used predictive biomarkers in mRCC pt management. Therefore, a better understanding of the biologic determinants associated with cancer heterogeneity and clinical outcomes through blood, tumor, and radiographic based assessments is needed. Importantly, longitudinal changes in health-related quality of life (QOL) and symptom burden of patients with mRCC initiated on new IO–based regimens outside of an interventional clinical trial are poorly understood. Pt reported outcomes (PRO) are rarely captured in a systematic manner. Addressing the evidence gap for how real world pts symptomatically change with treatment combinations and sequences over time is a pressing unmet need. Methods: This is a prospective, observational cohort, phase IV study of 800 mRCC pts in the US. Pts must: be age ≥19 at informed consent; have a diagnosis of mRCC (any histology) with no prior systemic therapy for mRCC (surgery and radiation therapy, prior neoadjuvant/adjuvant therapy for non-mRCC, and pts currently not on systemic therapy and being observed are all permitted); and be able to comply with completion of PROs. Those being treated for active malignancies other than mRCC or not intending to undergo follow up care at a study site within PCORnet are excluded. Pts will undergo consent and baseline assessments, including research blood collection and processing, by the study site team. A novel aspect of this study is the use of PCORnet and Medicare data to minimize data collection burden on sites. PCORnet, the National Patient-Centered Clinical Research Network, is a network of networks that curates EHR data from multiple health systems using a common data model. This allows subsequent follow up to be centrally coordinated by the coordinating center. PRO will be collected at baseline (pre-treatment), every 3 mos for 2 yrs, and then every 6 mos until end of follow up (minimum 18 mos follow-up; maximum 36 mos follow-up). The primary objective is to determine distinct patterns of change in QOL and symptom burden of mRCC pts receiving therapy. Secondary objectives include quantifying the time to treatment discontinuation of pts, identifying patterns of clinical management in the real world setting of mRCC pts on various treatment regimens, and evaluating overall survival of mRCC pts. ClinicalTrials.gov Identifier: NCT04919122 Clinical trial information: NCT04919122 .

Quality of Life Changes in Early-Onset Multiple Sclerosis: A 4-Year Follow-Up Study.

This study investigates longitudinal changes in health-related quality of life (HRQoL) in early-onset multiple sclerosis (MS) patients and explores the impact of disease activity (relapses) on such changes. People with MS (PwMS) onset between 12 and 25 years of age were followed longitudinally. At baseline and at year 4, patients were asked to fill the Paediatric Quality of life inventory (PedsQL). Demographic and clinical features were collected at both time points. Longitudinal within-group comparison of HRQoL total score and sub-scores was performed via paired samples t-test. The effect of relapses on the HRQoL changes over time was explored via linear mixed-effects analysis. No longitudinal changes were observed in the overall PedsQL score, nor in the physical, school and psychological functioning. An increase in the social functioning subscale (p < 0.001) and a decrease in the emotional subscale (p = 0.006) were observed. The change in social functioning, but not the one in the emotional subscale, was affected by the occurrence of relapses (p = 0.044). In conclusion, stimulating the patients to accept their emotional responses to health-related limitations, while preserving their social and relational resources seems key to the preservation of an adequate QoL over time in juvenile-onset MS.

Longitudinal Change in Health-Related Quality of Life after Total Gastrectomy: Approach Based on the Minimally Important Difference

Longitudinal Change in Health-Related Quality of Life after Total Gastrectomy: Approach Based on the Minimally Important Difference

Association of Acculturation Status with Longitudinal Changes in Health-Related Quality of Life-Results from a Cohort Study of Adults with Turkish Origin in Germany.

Health-related quality of life (HRQL) among migrant populations can be associated with acculturation (i.e., the process of adopting, acquiring and adjusting to a new cultural environment). Since there is a lack of longitudinal studies, we aimed to describe HRQL changes among adults of Turkish descent living in Berlin and Essen, Germany, and their association with acculturation. Participants of a population-based study were recruited in 2012–2013 and reinvited six years later to complete a questionnaire. Acculturation was assessed at baseline using the Frankfurt acculturation scale (integration, assimilation, separation and marginalization). HRQL was assessed at baseline (SF-8) and at follow-up (SF-12) resulting in a physical (PCS) and mental (MCS) sum score. Associations with acculturation and HRQL were analyzed with linear regression models using a time-by-acculturation status interaction term. In the study 330 persons were included (65% women, mean age ± standard deviation 43.3 ± 11.8 years). Over the 6 years, MCS decreased, while PCS remained stable. While cross-sectional analyses showed associations of acculturation status with both MCS and PCS, temporal changes including the time interaction term did not reveal associations of baseline acculturation status with HRQL. When investigating HRQL in acculturation, more longitudinal studies are needed to take changes in both HRQL and acculturation status into account.

Response shift in health-related quality of life measures in the presence of formative indicators

BackgroundResponse shift (RS) has been defined as a change in the meaning of an individual’s self-evaluation that needs to be accounted for when assessing longitudinal changes in health-related quality of life (HRQoL). RS detection through structural equation modeling is accomplished by adopting Oort’s procedure based on a measurement model in which the observed variables are defined as reflective indicators of the HRQoL latent variable; that is, the latent variable causes the variation in the reflective indicators. This study aims to propose a procedure that assesses RS when formative indicators are used in measuring HRQoL; in this last case, the latent variable is considered to be a function of some formative indicators. A secondary aim is to compare the new procedure with Oort’s procedure to highlight similarities and differences.MethodsThe data were retrieved from a consecutive series of 258 patients newly diagnosed with colorectal cancer and undergoing chemotherapy and/or surgery. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QOL-C30) was administered twice, once before and once six months after treatment. Structural equation modeling was used to evaluate RS and true change with the newly proposed method (in which fatigue and pain were defined as formative indicators) and with Oort’s procedure (in which fatigue and pain were defined as reflective indicators).ResultsAccording to the new procedure, there was no measurement bias, and on average, patients’ quality of life improved by 3.53 points (on a scale ranging from 0 to 100) at the 6-month follow-up. With Oort’s procedure, the loading of the pain indicator was not invariant across the two time points, suggesting the presence of reprioritization, whereas the estimation of true change was very similar to the previous one: 3.87.ConclusionsRS and true change in HRQoL can be evaluated in the presence of formative indicators. Defining a measurement model by formative or reflective indicators can lead to different results.

Longitudinal Changes in Health-related Quality of Life After 125I Low-dose-rate Brachytherapy for Localized Prostate Cancer.

The factors associated with longitudinal changes in health-related quality of life (HRQOL) are unclear. In this study we aimed to evaluate the longitudinal changes and predictors of HRQOL after 125I low-dose-rate brachytherapy (LDB) for localised prostate cancer (PCA). We evaluated 180 patients with localised PCA treated with LDB. The HRQOL was evaluated at 3 weeks before LDB and at 1, 3, 6, 12, 18, 24, 36, and 48 months after LDB using the International Prostate Symptom Score, Medical Outcome Study 8-Items Short Form Health Survey (SF-8), and University of California Los Angeles Prostate Cancer Index (UCLA-PCI). All HRQOL scores, except for UCLA-PCI sexual function and SF-8 mental component summary (MCS), were improved to baseline after an early transient deterioration. In contrast, the sexual function did not return to baseline after early deterioration. Meanwhile, the MCS scores showed no significant decline after implantation and trended upward. The prostate V100 and baseline UCLA-PCI sexual function scores predicted a clinically significant decrease in sexual function in the late post-implantation period. Most aspects of the HRQOL of PCA patients who underwent LDB improved to baseline. The results that V100 and baseline sexual function were predictors of late post-LDB may provide more accurate information for patients with preserved sexual function before treatment and for their partners.

Longitudinal Changes in Health-Related Quality of Life in Primary Glomerular Disease: Results From the CureGN Study

IntroductionPrior cross-sectional studies suggest that health-related quality of life (HRQOL) worsens with more severe glomerular disease. This longitudinal analysis was conducted to assess changes in HRQOL with changing disease status.MethodsCure Glomerulonephropathy (CureGN) is a cohort of patients with minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, IgA vasculitis, or IgA nephropathy. HRQOL was assessed at enrollment and follow-up visits 1 to 3 times annually for up to 5 years with the Patient-Reported Outcomes Measurement Information System (PROMIS). Global health, anxiety, and fatigue domains were measured in all; mobility was measured in children; and sleep-related impairment was measured in adults. Linear mixed effects models were used to evaluate HRQOL responsiveness to changes in disease status.ResultsA total of 469 children and 1146 adults with PROMIS scores were included in the analysis. HRQOL improved over time in nearly all domains, though group-level changes were modest. Edema was most consistently associated with worse HRQOL across domains among children and adults. A greater number of symptoms also predicted worse HRQOL in all domains. Sex, age, obesity, and serum albumin were associated with some HRQOL domains. The estimated glomerular filtration rate (eGFR) was only associated with fatigue and adult physical health; proteinuria was not associated with any HRQOL domain in adjusted models.ConclusionHRQOL measures were responsive to changes in disease activity, as indicated by edema. HRQOL over time was not predicted by laboratory-based markers of disease. Patient-reported edema and number of symptoms were the strongest predictors of HRQOL, highlighting the importance of the patient experience in glomerular disease. HRQOL outcomes inform understanding of the patient experience for children and adults with glomerular diseases.

Longitudinal changes in health-related quality of life according to clinical course among patients with non-tuberculous mycobacterial pulmonary disease: a prospective cohort study

BackgroundImprovement in health-related quality of life (HRQL) has been suggested as an alternative treatment goal of non-tuberculous mycobacterial pulmonary disease (NTM-PD). This study was performed to elucidate the longitudinal changes in HRQL using St. George’s Respiratory Questionnaire (SGRQ) among patients with NTM-PD according to their clinical course.MethodsPatients with NTM-PD who participated in Seoul National University Hospital’s prospective NTM cohort were screened. Participants for whom the SGRQ score was estimated with the one-year interval for ≥ three times were included. The longitudinal trends of the SGRQ score were assessed. The impact of the clinical course on the change in the SGRQ score was elucidated using multilevel mixed-effects linear regression with a repeated-measures model.ResultsIn total, 114 patients were analyzed. During the median 5-year observation period, 53 patients started anti-mycobacterial treatment and 61 patients were observed without treatment. Among the treated patients, 24 (45.2%) achieved microbiological cure. Patients who required treatment eventually had worsening SGRQ scores with time compared with patients who could be observed without treatment (P < 0.001). In cured patients, the SGRQ score decreased from 33.9 at baseline to 20.8 at 1 year post-treatment (P < 0.001), 21.3 at 2 years (P < 0.001), and 17.6 at 3 years (P < 0.001). The SGRQ scores also decreased for 2 years of treatment in patients with NTM-PD that could not be cured, although this decrease did not last for 3 years of treatment.ConclusionWorsening HRQL scores were associated with the initiation of treatment and, in turn, treatment improved HRQL scores of patients with NTM-PD.Trial registrationThis study was registered to the ClinicalTrials.gov (Identifier: NCT01616745 / registration date: June 12, 2012). The protocol was retrospectively registered.

Improvements in Health-Related Quality of Life and Symptoms in Patients with Previously Untreated Chronic Lymphocytic Leukemia: Final Results from the Phase II GIBB Study of the Combination of Obinutuzumab and Bendamustine

Improvements in Health-Related Quality of Life and Symptoms in Patients with Previously Untreated Chronic Lymphocytic Leukemia: Final Results from the Phase II GIBB Study of the Combination of Obinutuzumab and Bendamustine

Changes in health-related quality of life after radical prostatectomy for prostate cancer: A longitudinal cohort study in Korea.

PurposeTo evaluate longitudinal changes in health-related quality of life and satisfaction after radical prostatectomy for the treatment of prostate cancer in Korean men.Materials and MethodsData from patients with localized prostate cancer who underwent radical prostatectomy between January 2012 and December 2013 were analyzed. Patients completed the Expanded Prostate Cancer Index Composite questionnaire at scheduled clinic visits (baseline and 1, 3, 6, and 12 months post-surgery).ResultsData from 211 men were evaluated. Urinary domain summary scores decreased postoperatively but improved over the 12-month follow-up period. Urinary function and incontinence had not recovered to baseline values at 12 months, whereas urinary bother and irritation/obstruction scores showed no differences from baseline at 12 months. Sexual function improved at each timepoint to 12 months but did not recover to baseline values; sexual bother was approximately 50% of baseline values at 12 months. Recovery of sexual function was significantly greater in patients who underwent robotic surgery versus those who underwent open surgery. At the end of the study period, 66.3% of patients were satisfied with the treatment they had received; multivariate analysis showed that only urinary function recovery was significantly associated with overall satisfaction.ConclusionsUrinary outcomes and sexual outcomes had not returned to baseline at 12 months. Recovery of sexual function was significantly greater in patients who underwent robotic surgery. Only recovery of urinary function was significantly associated with overall satisfaction 12 months after radical prostatectomy in this cohort of Korean men.

Longitudinal changes in health-related quality of life during concussion recovery among youth athletes

ObjectiveDetermine longitudinal changes in health-related quality of life (HRQoL) in youth during recovery from a sport-related concussion.DesignProspective case-series.Participants68 youth (13–18 years; 62% male) with an acute sport-related concussion were enrolled with 5 lost to follow-up.Intervention (or assessment of risk factors)Subsequently developing Post-Concussion Syndrome (PCS: symptomatic after 30 days), initial symptom severity (Post Concussion Symptom Scale), concussion history, sex, age, and academic accommodations during recovery.Outcome measuresPedsQL Cognitive Functioning Scale and PedsQL 4.0 measured physical, social, and emotional domains of HRQoL. They were administered before each appointment until medical clearance. Multivariable mixed modelling accounted for repeated measures within an athlete and expressed as point increase per week.Main resultsInitial mean HRQoL was highest for social (non-PCS: 92.7 out of 100; PCS: 86.3), followed by emotional (non-PCS: 86.45; PCS: 69.7), physical (non-PCS: 80.95; PCS: 49.2), and cognitive domains (non-PCS: 69.1; PCS: 50.3). There was effect modification by developing PCS. Changes in HRQoL subscores were: cognitive functioning non-PCS (+9.8 points [95% CI: 6.9, 12.7]) and PCS (+4.2 points [95% CI: 2.8, 5.6]); social HRQoL non-PCS (+2.3 points [1.0, 4.0]) and PCS (+0.5 points [0.1, 1.0); emotional HRQoL non-PCS (+5.0 points [95% CI: 2.9, 7.0]) and PCS points (+2.2 [1.6, 2.9]); and physical non-PCS (+6.3 points [95% CI: [3.5, 9.2]) and PCS (+3.3 points (95% CI: 2.5, 4.2).ConclusionsHRQoL significantly improved longitudinally with greater improvement among non-PCS athletes. HRQoL impairment was most apparent in the cognitive and physical domains.Competing interestsNone.

Longitudinal change in health-related quality of life in people with prevalent and incident type 2 diabetes compared to diabetes-free controls.

ObjectiveThe objective of this analysis is to compare people with prevalent type 2 diabetes, incident type 2 diabetes and without diabetes with respect to longitudinal change in health-related quality of life (HRQOL) when adjusting for baseline determinants of HRQOL.Research design and methodsPrimary baseline and follow-up data from three regional and one national population-based cohort studies in Germany were pooled for analysis. HRQOL was measured using physical and mental health summary scores (PCS and MCS) from the German version of the Short Form Health Survey with 36 or 12 items. Mean score change per observation year was compared between the three groups (prevalent diabetes, incident diabetes, no diabetes) based on linear regression models.ResultsThe analysis included pooled data from 5367 people aged 45–74 years at baseline. Of these, 85.5% reported no diabetes at baseline and follow-up, 6.3% reported diabetes at both baseline and follow-up (prevalent diabetes), and 8.2% reported diabetes only at follow-up (incident diabetes). Over a mean observation period of 8.7 years, annual decline in HRQOL scores is pronounced at 0.27–0.32 (PCS) and 0.34–0.38 (MCS) in the group with prevalent diabetes compared with people without diabetes. Those with incident diabetes showed intermediate values but did not differ significantly from people without diabetes after adjustment for covariates in the full model.ConclusionCompared with data from cross-sectional analysis, the HRQOL loss associated with prevalent diabetes appears to be much larger than previously assumed.

Longitudinal changes in health-related quality of life in preschool children with cerebral palsy of different levels of motor severity

BackgroundWhen setting goals for cerebral palsy (CP) interventions, health-related quality of life (HRQoL) is an important outcome. AimsTo compare longitudinal changes in HRQoL in children with CP of different levels of motor severity. Methods and proceduresSeventy-three children with CP were collected and classified into three groups based on Gross Motor Function Classification System (GMFCS) levels. HRQoL was assessed by parent’s proxy of the TNO-AZL Preschool Quality of Life (TAPQOL) at baseline and 6 months later. Outcomes and resultsChildren with GMFCS level V had a lower total TAPQOL score and scores in all domains than those with level I–IV (p<0.01), except for the non-motor subdomain of physical functioning at follow-up. With regards to longitudinal changes, the children with GMFCS level V had greater improvements in physical (p=0.016) and cognitive functioning (p=0.042), but greater deterioration in emotional functioning (p=0.008) than those with levels I–II at 6 months of follow-up. Conclusions and implicationsMotor severity was associated with TAPQOL scores in all domains and changes in some domains in children with CP. Clinicians should early identify children at risk of a poor HRQoL and plan timely treatment strategies to enhance the HRQoL of children with CP.

Health‐related quality of life at healing in individuals with chronic venous or mixed‐venous leg ulceration: a longitudinal assessment

To identify factors associated with longitudinal changes in health-related quality of life in community-dwelling individuals with venous or mixed-venous leg ulcers. Most care focuses primarily on healing; this research may additionally lead to strategies to improve quality of life. Data from four studies (2000-2009) were combined (2012) to examine quality of life in community-dwelling individuals referred for care of chronic leg wounds. Data collection occurred at baseline, 3, 6, 9 and 12months or at healing and included a comprehensive clinical assessment and measures of pain (McGill), functional autonomy (EQ-5D™ ) and quality of life (SF-12TM ). Physical Component Summary and Mental Component Summary scores (SF-12TM ) were categorized by whether or not there was an improvement (≥3 points) over time. Multivariable logistic regression modelling was used to identify factors associated with improvement. Mean age of this sample (n=519) was 67·5years, 55·9% were women. Median time to healing was 70days. Mean Physical Component Summary score increased from 37·0-41·5; factors associated with improvement included independent mobility, family history, problems with usual activities, fewer comorbidities and higher baseline pain. Mean Mental Component Summary score improved from 50·5-53·7; factors associated with improvement included anxiety or depression at baseline and living with others. Chronic leg ulceration has a substantial, negative impact on health-related quality of life. Ascertaining characteristics associated with changes in quality of life will contribute to the development of comprehensive strategies for prevention, care and improved quality of life.

(46) - Reduced Anxiety and Depression in Patients with Advanced Heart Failure after Left Ventricular Assist Device Implantation

s S25 Purpose: Longitudinal change in health-related quality of life (HRQOL) by left ventricular assist device (LVAD) implant strategy is unknown. The purpose of this study was to examine if generic and heart failure-specific HRQOL differs by pre-operative implant strategy from pre-implant to 2 years (yrs) post implant. Methods: Data from adult patients (pts) in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) were stratified into three groups: destination therapy (DT), bridge to transplant (BTT), and bridge to candidacy (BTC [BTT likely, moderately likely, and unlikely]). Data were collected pre-implant and 1yr and 2yrs post implant. HRQOL was measured with the EQ-5D-3L generic survey visual analog scale [VAS health status, 0= worst-100= best), and heart failure (HF)-specific KCCQ12 overall summary (OS) score of 4 domains (physical limitations, symptom frequency, quality of life, and social limitations). Statistical analyses included descriptive statistics, chi square, analysis of variance, and paired t-tests. Results: Between 04/01/08-06/30/13, 7227 and 4505 pts who received primary continuous flow LVADs had VAS and KCCQ-12 HRQOL data, respectively, at baseline. Longitudinally, mean VAS scores for all 3 groups improved significantly from pre to 2 yrs post implant (figure 1). Similar to the VAS, KCCQ-12 OS scores improved over time for all 3 groups (figure 1). Sensitivity analyses, using only paired data (pre implant and 2 years post implant), for both the EQ-5D-3L VAS and KCCQ-12 OS support these findings. Conclusion: Overall, HRQOL improves from before to 2 yrs after LVAD implant for pts with all 3 implant strategies, assessed by both a generic and HF-specific instrument. These findings suggest that all implant strategy groups, regardless of intent to transplant or not, may derive HRQOL-related benefit from before to mid-term after LVAD implantation.

Impact of Spironolactone on Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial.

Heart failure (HF) with preserved ejection fraction patients have equally impaired health-related quality of life (HRQL) compared with those with HF with reduced ejection fraction, but limited studies have evaluated the impact of therapies on changes in HRQL. Patients ≥50 years of age, with symptomatic HF and left ventricular ejection fraction ≥45%, were enrolled in Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) and randomized to spironolactone or placebo. Patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ), which was the primary HRQL instrument, and EQ5D visual analog scale at baseline, 4 months, 12 months, and annually thereafter. McMaster Overall Treatment Evaluation was assessed at 4 and 12 months to assess global change scores. Change scores (+SD) were calculated to determine between-group differences, and multivariable repeated-measures models were created to identify other factors associated with change scores. Paired KCCQ data were available for 91.7% of 3445 TOPCAT patients. By 4 months, the mean change in KCCQ was 7.7±16 and mean change in EQ5D visual analog scale was 4.7±16. Adjusted mean changes in KCCQ for the spironolactone group were significantly better than those for the placebo group at 4-month (1.54 better; P=0.002), 12-month (1.35 better; P=0.02), and 36-month (1.86 better; P=0.02) visits. No between-group differences in EQ5D visual analog scale change scores or McMaster Overall Treatment Evaluation were noted. Older age, obesity, current smoking, New York Heart Association class III/IV, and comorbid illnesses were associated with declines in KCCQ scores. Use of spironolactone was an independent predictor of improved KCCQ scores. In symptomatic HF with preserved ejection fraction patients, use of spironolactone was associated with an improvement in HF-specific HRQL. Several modifiable risk factors were associated with HRQL deterioration. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00094302.