scholarly journals Health-Related Quality of Life in the Spironolactone to Reduce ICD Therapy (SPIRIT) Trial

Author(s):  
Ana Carolina Sauer Liberato ◽  
Merritt H Raitt ◽  
Ignatius GE Zarraga ◽  
Karen S MacMurdy ◽  
Cynthia Dougherty

Purpose: The Spironolactone to Reduce ICD Therapy (SPIRIT) trial was designed to determine whether once daily spironolactone would: 1) reduce the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF), and 2) improve health related quality of life (HRQOL) and symptoms. The purpose of this paper is to describe the long term HRQOL outcomes in the SPIRIT trial and compare QOL in those who did or did not receive implantable cardioverter defibrillator (ICD) shocks during follow-up. Methods: Ninety participants age 66+10 years, 96% men, 75% with NYHA class II, with an ICD at moderately high risk for recurrent VT/VF were randomized to spironolactone 25mg (N=44) or placebo (N=46). HRQOL was measured every 6 months for 24 months using 3 instruments: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and the Kansas City Cardiomyopathy Questionnaire (KCCQ). Linear mixed modeling was used to compare changes in HRQOL across 24-months. ANCOVA was used to compare HRQOL between those getting an ICD shock or not. Results: Over 24-months, there were no differences in HRQOL between the spironolactone vs. placebo groups. Those who experienced at least 1 ICD shock vs. those with no ICD shocks, reported significantly lower HRQOL and more symptoms at 6-months and 24 months. Conclusions: Spironolactone had no significant impact on HRQOL. Patients receiving one or more ICD shocks reported significant reductions in HRQOL and higher symptoms.

2021 ◽  
pp. 105477382110368
Author(s):  
Ana C. S. Liberato ◽  
Merritt H. Raitt ◽  
Ignatius Gerardo E. Zarraga ◽  
Karen S. MacMurdy ◽  
Cynthia M. Dougherty

To describe health related quality of life (HRQOL) and symptoms in the SPIRIT trial and determine effects of implantable cardioverter defibrillator (ICD) shocks on HRQOL over 24 months. Ninety participants aged 66 ± 10 years, 96% men, 75% with NYHA class II, with an ICD were randomized to spironolactone 25 mg ( N = 44) or placebo ( N = 46). HRQOL was measured every 6 months for 24 months using: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and Kansas City Cardiomyopathy Questionnaire (KCCQ). Linear mixed modeling compared changes in HRQOL over-time and ANCOVA compared HRQOL between those getting an ICD shock or not. Over 24-months, there were no differences in HRQOL between the spironolactone versus placebo groups. Those with at least one ICD shock reported significantly lower HRQOL and more symptoms at 6- and 24-months. Patients receiving one or more ICD shocks reported significant reductions in HRQOL and higher symptoms.


2018 ◽  
Vol 25 (4) ◽  
pp. 140-151
Author(s):  
Markus A. Wirtz ◽  
Matthias Morfeld ◽  
Elmar Brähler ◽  
Andreas Hinz ◽  
Heide Glaesmer

Abstract. The association between health-related quality of life (HRQoL; Short-Form Health Survey-12; SF-12) and patient-reported morbidity-related symptoms measured by the Patient Health Questionnaire-15 (PHQ-15) is analyzed in a representative sample of older people in the general German population. Data from 1,659 people aged 60 to 85 years were obtained. Latent class analysis identified six classes of patients, which optimally categorize clusters of physical symptoms the participants reported: musculoskeletal impairments (39.8%), healthy (25.7%), musculoskeletal and respiratory/cardiac impairments (12.8%), musculoskeletal and respiratory impairments, along with bowel and digestion problems (12.9%), general impairments (4.9%), and general impairments with no bowel and digestion problems (4.8%). The participants’ SF-12 Physical Health Scores (η2 = .39) and their Mental Health Scores (η2 = .28) are highly associated with these latent classes. These associations remain virtually identical after controlling for age. The results provide evidence that profiles of patient-reported physical impairments correspond strongly with reduced HRQoL independently from aging processes.


2021 ◽  
Vol 12 (3) ◽  
pp. 344-351
Author(s):  
Julie Cleuziou ◽  
Anna-Katharina Huber ◽  
Martina Strbad ◽  
Masamichi Ono ◽  
Alfred Hager ◽  
...  

Background: Long-term morbidity and mortality outcomes of the arterial switch operation (ASO) in patients with transposition of the great arteries and Taussig-Bing anomaly are excellent. With an increasing number of patients reaching adolescence and adulthood, more attention is directed toward quality of life. Our study aimed to determine the health-related quality of life (hrQoL) outcomes in patients after the ASO and identify factors influencing their hrQoL. Methods: In this cross-sectional study, hrQoL of patients after ASO was assessed with the German version of the Short Form-36 (SF-36) and the potential association of specified clinical factors was analyzed. Patients of at least 14 years of age who underwent ASO in our institution from 1983 were considered eligible. Results: Of the 355 questionnaires sent to eligible patients, 261 (73%) were available for analysis. Compared to the reference population, patients who had undergone ASO had a significantly higher score in all subscales of the SF-36 except for vitality ( P < .01). Patients with an implanted pacemaker ( P = .002), patients who required at least one reoperation ( P < .001), and patients currently taking cardiac medication ( P < .004) or oral anticoagulation ( P = .036) had lower physical component scores compared to patients without these factors. Conclusions: Patients’ self-assessed and self-reported hrQoL after ASO (using German version of the Short Form 36) is very good. In this population, hrQoL is influenced by reoperation, the need for a pacemaker, and current cardiac medication or anticoagulant use. The development of strategies designed to mitigate or minimize the requirements for, and/or impact of these factors may lead to better hrQoL in this patient population.


2013 ◽  
Vol 20 (2) ◽  
pp. 253-257 ◽  
Author(s):  
Mariko Kita ◽  
Robert J Fox ◽  
J Theodore Phillips ◽  
Michael Hutchinson ◽  
Eva Havrdova ◽  
...  

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.


2015 ◽  
Vol 37 (2) ◽  
pp. 221-242 ◽  
Author(s):  
XIAOJIE SUN ◽  
KUN LIU ◽  
MARTIN WEBBER ◽  
LIZHENG SHI

ABSTRACTNo study based on the Resource Generator has explored the association between individual social capital and health-related quality of life among older adults. This study aims to evaluate the validity and reliability of the adapted Resource Generator-China, and examine the association between individual social capital measured by the Resource Generator-China and health-related quality of life of older rural-dwelling Chinese people. A field survey including 975 rural-dwelling people aged between 60 and 75 years was conducted in three counties of the Shandong Province of China in 2013. Quality of life was measured by the Chinese version of the 36-Item Short Form Health Survey (SF-36): scores of Physical Component Summary and Mental Component Summary. Cumulative scale analyses were performed to analyse the homogeneity and reliability of the Resource Generator-China. We constructed generalised linear models by gender to examine the associations of social capital with health-related quality of life. Our findings suggest that the adapted instrument for older rural-dwelling Chinese people can be a reliable and valid measure of access to individual social capital. There were positive associations between individual social capital (total scores and sub-scale scores) and health-related quality of life. Individual social capital had a stronger association with mental health among women than men. Future studies should be improved through a longitudinal design with a larger and randomised sample covering large geographical rural areas in China.


2018 ◽  
Vol 4 ◽  
pp. 233372141878281 ◽  
Author(s):  
Esmeralda Valdivieso-Mora ◽  
Mirjana Ivanisevic ◽  
Leslie A. Shaw ◽  
Mauricio Garnier-Villarreal ◽  
Zachary D. Green ◽  
...  

Rheumatology ◽  
2018 ◽  
Vol 58 (4) ◽  
pp. 628-635 ◽  
Author(s):  
Michel W P Tsang-A-Sjoe ◽  
Irene E M Bultink ◽  
Maaike Heslinga ◽  
Lilian H van Tuyl ◽  
Ronald F van Vollenhoven ◽  
...  

Abstract Objective To investigate the relationship between remission and health-related quality of life (HRQoL) in patients with SLE in a longitudinal observational cohort. Methods HRQoL was measured at cohort visits using the physical and mental component score (PCS and MCS, respectively) of the Short Form 36 questionnaire. Definitions of Remission in SLE remission categories (no remission/remission on therapy/remission off therapy) were applied. Determinants of PCS and MCS were identified with simple linear regression analyses. Association between remission and HRQoL was assessed using generalized estimating equation models. Results Data from 154 patients with 2 years of follow-up were analysed. At baseline 60/154 (39.0%) patients were in either form of remission. Patients in remission had higher Short Form 36 scores in all subdomains compared with patients not in remission. PCS was positively associated with remission and employment, and negatively associated with SLICC damage index, ESR, medication, patient global assessment and BMI. MCS was positively associated with Caucasian ethnicity and negatively associated with patient global assessment. In generalized estimating equation analysis, a gradual and significant increase of PCS was observed from patients not in remission (mean PCS 36.0) to remission on therapy (41.8) to remission off therapy (44.8). No significant difference in MCS was found between remission states. Conclusion we show a strong and persistent association between remission and PCS, but not MCS. These results support the relevance (construct validity) of the Definition of Remission in SLE remission definitions and the further development of a treat-to-target approach in SLE.


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