Improvements In Physical Quality Of Life Research Articles

Effect of nusinersen treatment on quality of life and motor function in adult patients with spinal muscular atrophy

The aim of this study was to assess the effect of 4 loading doses of nusinersen on motor function and quality of life (QoL) in adult patients with spinal muscular atrophy (SMA). Twenty-one adult patients with genetically confirmed SMA who were treated with 4 loading doses of nusinersen were included in this study. All patients were evaluated with the Medical Research Council (MRC) scale, the Hammersmith Functional Motor Scale Expanded (HFMSE), and the Short Form Survey-36 (SF-36) at baseline (V1) and before the first nusinersen maintenance treatment, which was at the 15th month of treatment (V2). The SF-36 score was compared between the patients and 35 age-matched healthy controls. Of the twenty-one patients with a median age of 36 years, 10 were nonambulatory, and 11 were ambulatory. The physical component score and the mental component score of the SF-36 were significantly lower in the SMA patient group at baseline than in the healthy group. The median HFMSE scores significantly improved at V2 in both ambulatory and nonambulatory SMA patients (p < 0.05). The median MRC score significantly increased at V2 in the ambulatory SMA patient group (p = 0.04) but not in the nonambulatory SMA patient group (p = 0.19). There was a significant improvement in physical QoL in all the SMA patients at V2 (p = 0.02), but there was no significant improvement in mental QoL (p = 0.15). The loading nusinersen treatment significantly improved motor function scores, muscle strength, and physical QoL.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Efficacy of Diet on Fatigue and Quality of Life in Multiple Sclerosis: A Systematic Review and Network Meta-analysis of Randomized Trials.

Emerging evidence suggests a role for diet in multiple sclerosis (MS) care; however, owing to methodological issues and heterogeneity of dietary interventions in preliminary trials, the current state of evidence does not support dietary recommendations for MS. The objective of this study was to assess the efficacy of different dietary approaches on MS-related fatigue and quality of life (QoL) through a systematic review of the literature and network meta-analysis (NMA). Electronic database searches were performed in May 2021. Inclusion criteria were (1) randomized trial with a dietary intervention, (2) adults with definitive MS based on McDonald criteria, (3) patient-reported outcomes for fatigue and/or QoL, and (4) minimum intervention period of 4 weeks. For each outcome, standardized mean differences (SMDs) were calculated and included in random effects NMA to determine the pooled effect of each dietary intervention relative to each of the other dietary interventions. The protocol was registered at PROSPERO (CRD42021262648). Twelve trials comparing 8 dietary interventions (low-fat, Mediterranean, ketogenic, anti-inflammatory, Paleolithic, fasting, calorie restriction, and control [usual diet]), enrolling 608 participants, were included in the primary analysis. The Paleolithic (SMD -1.27; 95% CI -1.81 to -0.74), low-fat (SMD -0.90; 95% CI -1.39 to -0.42), and Mediterranean (SMD -0.89; 95% CI -1.15 to -0.64) diets showed greater reductions in fatigue compared with control. The Paleolithic (SMD 1.01; 95% CI 0.40-1.63) and Mediterranean (SMD 0.47; 95% CI 0.08-0.86) diets showed greater improvements in physical QoL compared with control. For improving mental QoL, the Paleolithic (SMD 0.81; 95% CI 0.26-1.37) and Mediterranean (SMD 0.36; 95% CI 0.06-0.65) diets were more effective compared with control. However, the NutriGRADE credibility of evidence for all direct comparisons is very low because of most of the included trials having high or moderate risk of bias, small sample sizes, and the limited number of studies included in this NMA. Several dietary interventions may reduce MS-related fatigue and improve physical and mental QoL; however, because of the limitations of this NMA, which are driven by the low quality of the included trials, these findings must be confirmed in high-quality, randomized, controlled trials.

Differences in quality of life improvement with pulmonary vein isolation alone vs. more extensive ablation of persistent atrial fibrillation: insights from the EARNEST-PVI trial

Abstract Background Improving the quality of life (QoL) is one of the main purposes of catheter ablation (CA) of persistent atrial fibrillation (AF). QoL improvement in persistent AF patients has not been fully clarified. The EARNEST-PVI trial was a multi-center randomized trial comparing clinical outcomes of pulmonary vein isolation (PVI) alone and more intensive ablation in addition to PVI including complex fractionated atrial electrogram (CFAE) and linear ablation (PVI plus). Purpose To investigate the QoL change after persistent AF ablation and the differences between the PVI-alone strategy and the PVI plus strategy. Methods In the EARNEST-PVI trial, patients with persistent AF who underwent an initial catheter ablation (n=512) were randomly assigned in a 1:1 ratio to either PVI alone or PVI plus. Quality of life was assessed at baseline and at 12 months after ablation for AF using the 36-Item Short Form Health Survey. Scores were also converted to a physical health component summary (PCS), a mental health component summary (MCS) and a role/social component summary (RCS). Results In the EARNEST-PVI trial, the PVI alone strategy was associated with higher recurrence rate compared with the PVI plus additional ablation strategy. After excluding 68 patients for whom preoperative or postoperative QoL assessment was not available, 222 patients were evaluated respectively. Overall, significant improvements in PCS (46.2±11.4 to 48.7±11.4]), MCS (50.1±8.8 to 54.3±8.6) and RCS (44.6±13.3 to 48.6±11.3) occurred 12 months after ablation (P&amp;lt;0.001, respectively). Although significant QoL improvement occurred in both PVI alone and PLI plus strategies, the changes in PCS was greater in the PVI-plus than that in PVI-alone (3.5±10.3 vs 1.5±10.6, P=0.04). Conclusions Ablation for persistent atrial fibrillation improved both physical and mental quality of life. The PVI-plus strategy showed greater improvement in physical QoL. Funding Acknowledgement Type of funding sources: None. QoL improvement

Treatment Outcomes in Aspirin-Exacerbated Respiratory Disease Based on the 12-Item Short Form Survey.

Aspirin-exacerbated respiratory disease (AERD) is optimally managed by endoscopic sinus surgery (ESS) followed by aspirin therapy after desensitization (ATAD). Most AERD quality of life (QOL) studies use the 22-item Sinonasal Outcomes Test (SNOT-22), which focuses predominantly on sinonasal outcomes. This study seeks to assess QOL outcomes in AERD patients after ESS and ATAD via the 12-item Short Form Survey (SF-12), a well-validated QOL measure for general health status of chronic conditions. Retrospective review of 112 AERD patients who underwent ESS followed by ATAD at our institution between 2016 and 2019. SF-12 was collected preoperatively, postoperatively/pre-AD, and serially post-AD (1-3, 4-6, 7-12, and >12 months). Optum® PRO CoRE software was used to compare data to national norms. ANOVA was performed comparing physical component summary (PCS), mental component summary (MCS) and eight health domains (physical functioning, role physical, general health, bodily pain, vitality, social functioning, role emotional, and mental health). AERD patients showed improvement in PCS scores across all timepoints after ESS and ATAD (p = 0.004). When stratified by gender, women demonstrated an improvement in PCS scores (p = 0.004). Within the domains, there were significant improvements in social functioning (SF), role physical (RP), and bodily pain (BP) at all timepoints (SF: p = 0.006; RP: p = 0.005; BP: p < 0.001). AERD patients undergoing ESS and ATAD show improvement in physical QOL and 3 of the 8 health domains as measured by the SF-12. Future studies can use the SF-12 to study the impact of AERD treatment versus other chronic diseases and health demographics.

Intrinsic reward circuit connectivity profiles underlying symptom and quality of life outcomes following antidepressant medication: a report from the iSPOT-D trial.

There is a critical need to better understand the neural basis of antidepressant medication (ADM) response with respect to both symptom alleviation and quality of life (QoL) in major depressive disorder (MDD). Reward neurocircuitry has been implicated in QoL, the neural basis of MDD, and the mechanisms of ADM response. Yet, we do not know whether change in reward neurocircuitry as a function of ADM is associated with change in symptoms and QoL. To address this gap in knowledge, we analyzed data from 128 patients with MDD who participated in the iSPOT-D trial and were assessed with functional neuroimaging pre- and post-ADM treatment (randomized to sertraline, venlafaxine-XR, or escitalopram). 58 matched healthy controls were scanned at the same time points. We quantified functional connectivity (FC) of reward neurocircuitry using nucleus accumbens (NAc) seed regions of interest, and then characterized how changes in FC relate to symptom response (primary outcome) and QoL response (secondary outcome). Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC) FC relative to non-responders (p < 0.001) which was associated with improvement in physical QoL (p < 0.0003), and a decrease in NAc-inferior parietal lobule FC relative to controls (p < 0.001). QoL response was characterized by increases in FC between NAc-ventral ACC for environmental, NAc-thalamus for physical, and NAc-paracingulate gyrus for social domains (p < 0.001). Symptom responders to sertraline were distinguished by a decrease in NAc-insula FC (p < 0.001) and to venlafaxine-XR by an increase in NAc-inferior temporal gyrus FC (p < 0.005). Findings suggest that change in reward neurocircuitry may underlie differential ADM response profiles with respect to symptoms and QoL in depression.

Different Effects of Pulmonary Vein Isolation on Quality of Life Between Patients with Persistent and Paroxysmal Atrial Fibrillation.

The effect of restoring sinus rhythm by pulmonary vein isolation (PVI) on the quality of life (QOL) of patients with persistent atrial fibrillation (PerAF) has not been adequately investigated. This study was performed to compare the changes in QOL after extended PVI between patients with PerAF and paroxysmal AF (PAF).Patients with PAF (n = 38) and PerAF (n = 22) who underwent their first PVI and developed no AF recurrence 6 months after PVI were enrolled. QOL surveys were performed at baseline and 6 months post-ablation using Short Form-36 surveys.The mental component summary score (MCS) (53.4 ± 10.2 to 56.5 ± 7.1, P = 0.019) and physical component summary score (PCS) (46.1 ± 10.6 to 48.5 ± 8.3, P = 0.015) improved after PVI in the PAF group. The PCS, but not the MCS, improved after PVI in the PerAF group (45.8 ± 7.9 to 51.5 ± 6.2, P < 0.001). Changes in the PCS were greater in the PerAF group than in the PAF group (8.6 ± 6.9 versus 2.8 ± 5.2, P = 0.009). Multivariate regression analysis demonstrated that a low baseline MCS and the type of AF (PAF) were independent predictors of an increased MCS and that a low baseline PCS and the type of AF (PerAF) were independent predictors of an increased PCS.The changes in QOL differed between PAF and PerAF after PVI. Although most patients with PerAF were asymptomatic before PVI, their improvement in physical QOL was greater than that in patients with PAF. Such beneficial effects on physical QOL are likely expected in patients with PerAF with a low PCS before PVI.

Sustainability of the relationship between preoperative symptoms and postoperative improvement in quality of life after inguinal hernia repair.

Chronic pain and discomfort are common before and after inguinal hernia repair (IHR) and pain is clearly linked to reduced quality of life (QoL). The long-term effect of IHR on QoL in relation to preoperative symptoms is incompletely described. 309 men (18-75years) undergoing IHR under local anesthesia and day care surgery were included. Pre- and postoperative symptoms, pain and QoL (SF-36) were measured before and up to 3years after surgery. Before surgery, 197 patients (64%) reported pain (VAS 0.9-5.4) from their inguinal hernia. 102 patients (33%) had other inguinal symptoms, and 26% were asymptomatic. Patients with preoperative groin pain (P) scored their physical QoL (PCS) lower compared with controls (C) (median (IQR) 43.5 (34.7-50.3) vs. 53.9 (47.8-56.9, p < 0.001)), whereas patients with no pain (N) did not (53.0 (47.9-55.9), p = 0.57). Mental QoL was not affected before or after surgery. At 1, 2 and 3years after surgery, 14, 12 and 7% of patients, respectively, reported groin pain. In P, PCS increased from 43.5 before surgery to 55.3 (p < 0.001) at 36 months, but was unchanged in N (53.0 vs 55.9, p = ns). The incidence of inguinal pain decreases over time after inguinal hernia repair. Both preoperative reduction and long-term improvement in physical QoL are strongly associated with the presence of preoperative groin pain. This supports, from a QoL perspective, that patients with preoperative pain are those who benefit the most from IHR, also from a long-term perspective.

Home practice and quality of life among patients with neurofibromatosis randomized to a mind-body intervention

ObjectivesThe purpose of this study was to summarize home practice in patients with neurofibromatosis (NF) randomized to an 8-week group mind-body intervention, the Relaxation Response Resiliency Program for NF (3RP-NF). We further examined the association between home practice and changes in four domains of quality of life (QoL). MethodsData are derived from a single-blind RCT of the 3RP-NF (N = 31) delivered via videoconferencing versus an attention placebo control. 3RP-NF participants submitted weekly home practice logs to the group leader prior to each weekly session, which included information regarding their engagement of relaxation response (RR)-eliciting skills and appreciation skills. Physical, psychological, social and environmental QoL were measured at baseline, post-intervention and at a 6-months follow up. ResultsParticipants reported engaging in home practice of RR-eliciting skills on average 28.55 days (SD = 10.79) and appreciation skills on average 24.39 days (SD = 13.48) over the 49-day treatment period. Participants reported an average of 383.42 (SD = 274.38) minutes of RR-eliciting skills home practice and an average of 49.13 (SD = 41.90) appreciations skills home practice. A significant association was observed between frequency of RR-eliciting skills home practice and physical QoL at the 6-month follow-up (r = .383, p = .034). ConclusionsParticipants with NF are able and willing to practice RR-eliciting skills and appreciation skills outside of treatment sessions. Frequency of RR-eliciting skills home practice may be associated with improvement in physical QoL. Future research should replicate these efforts with larger samples, and attempt to identify additional factors that predict optimal response to mind-body interventions other than home practice.

Quality of Life Outcomes of Bariatric Surgery: A Systematic Review.

Bariatric surgery is often pursued to improve quality of life (QOL). This paper systematically reviews the literature examining QOL following bariatric surgery. Fifteen controlled trials examined changes in QOL in obese (BMI > 30) adults (18–65 years) following bariatric surgery; seven compared bariatric surgery to non-surgical interventions and six compared different types of bariatric surgery. Bariatric surgery resulted in greater improvements in QOL than other obesity treatments. Significant differences in QOL improvements were found between different types of bariatric surgery. QOL improvements were more likely to occur within the first 2 years following surgery, with greater improvements in physical QOL than mental QOL. Bariatric surgery improves QOL. Future research is needed to investigate changes in QOL in different domains in the short- and long-term following bariatric surgery.

Patient-Centered Outcomes Following Thoracentesis.

BackgroundPleural effusions impact over 1.5 million people annually in the United States and cause significant morbidity. Although therapeutic thoracentesis is associated with improvement in respiratory parameters, unanswered questions remain regarding its impact.ObjectiveThe purpose of this study was to investigate patient-centered outcomes, the need for additional pleural interventions, and mortality in the 30 days following thoracentesis.MethodsThis prospective observational cohort study was performed in a tertiary care academic medical center between December 2010 and December 2011. Adult patients referred for thoracentesis were offered enrollment. The following characteristics were evaluated both before and at 30 days postprocedure: dyspnea using modified BORG (mBORG), physical and mental quality of life (QoL) using the short form 12, and basic activities of daily living (BADLs). The primary outcomes included changes in these parameters 30 days after thoracentesis. Secondary outcomes included the need for additional pleural procedures and mortality within 30 days of the thoracentesis. Multivariable logistic regression was used for analysis.ResultsOf the 284 patients who underwent thoracentesis, 80 (28.2%) died within 30 days of the procedure. Of the 163 patients comprising the analytical cohort, 35 (21.5%) patients required an additional pleural intervention within 30 days of the index procedure. Patients who survived more than 30 days following thoracentesis had a sustained improvement in dyspnea and mental QoL, but a minority had improvement in physical QoL or BADLs. Surviving patients demonstrated no significant associations between bilateral and unilateral thoracentesis, volume of fluid removed, or the etiology of the effusion (malignant vs nonmalignant) and improvement in QoL, dyspnea, and BADLs. Relative to nonmalignant etiology, the presence of a malignant effusion was strongly associated with the need for an additional intervention, yielding an odds ratio (95% confidence interval [95% CI]) of 16.92 (5.47-52.37). Patients with hepatic hydrothorax and infectious etiologies of their effusion were also likely to require additional pleural interventions.ConclusionThe majority of patients in this cohort demonstrated sustained improvement in dyspnea and the mental aspect of QoL 30 days following thoracentesis, independent of the etiology and regardless of the volume of pleural fluid removed. A minority experienced sustained improvements in the physical aspect of QoL and BADLs. Although 28.2% of patients died within 30 days, nearly 1 in 5 survivors required an additional pleural intervention. These results emphasize the significant clinical impact, morbidity, and mortality experienced by patients who undergo thoracentesis for pleural effusions.

Quality of life after Roux-en-Y gastric bypass and changes in body mass index and obesity-related comorbidities

AimDynamics of improvement in health-related quality of life (QoL) after bariatric surgery have never been fully assessed, and neither has the potential influence of body mass index (BMI) and comorbidity modification. The objective of this study was to investigate early and medium-term changes in QoL following Roux-en-Y gastric bypass (RYGB), and their relationship to BMI and comorbidity variations. MethodsA total of 71 obese subjects (80% women, mean age 42.1±11.2 years, mean baseline BMI 47.6±6.2kg/m2) undergoing RYGB filled in QoL questionnaires (SF-36) before and 3, 6 and 12 months after surgery. QoL was assessed using repeated-measures Anova, with associations between its changes and changes in BMI and comorbidities (diabetes, hypertension, dyslipidaemia, sleep apnoea, knee pain) assessed by mixed-effects models. ResultsPhysical QoL scales (physical component summary, PCS) significantly increased over time (from 38.9±9.3 to 52.6±7.9; P<0.001) as did other physical SF-36 scales (all P<0.001), whereas mental QoL summary scale did not vary significantly (from 45.7±9.5 to 48.6±11.5; P=0.072). Major changes in QoL occurred at 3 months after surgical intervention to reach values comparable to those in the general population. PCS was mostly associated with changes in either BMI or comorbidity status except for diabetes, dyslipidaemia and sleep apnoea. ConclusionResults show that improvements in physical QoL after RYGB are observed as early as 3 months after intervention, and are independently associated with weight loss and improvements in comorbidities.

The Influence of Alcohol Abuse History on the Differential, Longitudinal Patterns of Mental and Physical Quality of Life Following Liver Transplantation

This prospective, longitudinal study investigated change in physical and mental health quality of life (QoL) in a sample of 65 end-stage liver disease patients before and after liver transplantation. Physical and mental health QoL were assessed using the SF-36 Physical Health Summary and Mental Health Summary, respectively. Baseline data were collected prior to transplant and follow-up data were collected at 1 and 6 months after transplantation. Repeated-measures analysis of variance results indicate that physical QoL did not improve significantly between baseline and 1-month follow-up ( F = .031, P = .860) but did between 1- and 6-month follow-up ( F = 20.873, P < .001). Significant between-subject effects suggested attenuated improvement for patients with alcohol abuse histories ( F = 6.213, P = .017). Physical QoL did not improve between 1- and 6-month follow-up for patients with alcohol abuse history ( t (13) = −1.074, P = .112). By contrast, mental health QoL improved significantly between baseline and 1-month follow-up ( F = 13.840, P < .001), but not between 1- and 6-month follow-up ( F = .750, P = .391). No significant differences were found on the Mental Health Summary index based on alcohol abuse history for either time period. Post hoc multivariate analysis of variance results suggested worse functioning ( F = 2.674, P = .013) for individuals with alcohol abuse history on SF-36 Physical Functioning ( F = 5.55, P = .021), Body Pain ( F = 13.578, P < .001), Vitality ( F = 4.337, P = .040), and Social Functioning ( F = 10.50, P = .002) subscales. For liver transplant patients, improvements in psychosocial functioning and QoL precede improvements in physical QoL. Attenuated physical QoL improvements for patients with alcohol abuse histories are related to greater pain and physical deficits.

The effects of exercise interventions on quality of life in clinical and healthy populations; a meta-analysis

The aim of the study was to provide an overview of the effect of exercise interventions on subjective quality of life (QoL) across adult clinical populations and well people, and to systematically investigate the impact of the exercise setting, intensity and type on these outcomes. From a systematic search of six electronic databases, 56 original studies were extracted, reporting on 7937 sick and well people. A meta-analysis was conducted on change in QoL from pre- to post-intervention compared with outcomes from a no-exercise control group, using weighted (by the study's sample size) pooled mean effect sizes and a fixed-effects model. Significant differences in outcome were found when treatment purpose was compared; prevention/promotion (well populations), rehabilitation, or disease management. Three to 6 months post-baseline, a moderate positive effect of exercise interventions was found for overall QoL in rehabilitation patients, but no significant effect for well or disease management groups. However, physical and psychological QoL domains improved significantly relative to controls in well participants. Psychological QoL was significantly poorer relative to controls in the disease management group. This pattern of results persisted over 1 year. With some exceptions, better overall QoL was reported for light intensity exercise undertaken in group settings, with greater improvement in physical QoL following moderate intensity exercise. The implications for future health care practice and research are discussed.