Improvement In Overall Quality Of Life Research Articles

Abstract 4140102: Changes in EQ-5D-5L with Aficamten in Obstructive Hypertrophic Cardiomyopathy (oHCM): the SEQUOIA-HCM Trial

Introduction: In patients with obstructive hypertrophic cardiomyopathy (oHCM), the SEQUOIA-HCM trial demonstrated that aficamten, a next-in-class cardiac myosin inhibitor, improved exercise capacity, heart failure symptoms and hemodynamics compared with placebo. Aficamten’s impact on overall quality-of-life (QoL) in oHCM has not been reported. Hypothesis: Aficamten, compared with placebo, improves QoL as assessed by the EQ-5D-5L. Aims: To describe EQ-5D-5L changes in patients enrolled in SEQUOIA-HCM. Methods: SEQUOIA-HCM (NCT05186818) is a phase III, placebo-controlled trial of adults with symptomatic oHCM randomized to aficamten (n=142) or placebo (n=140) on top of standard-of-care medical therapy. Participants underwent blinded dose escalation over 6 weeks and were treated for 24 weeks followed by a 4-week washout. EQ-5D-5L (ranges from 0 to 1) and overall QoL using the Visual Analogue Scale (VAS; from 0 to 100) was measured at baseline through week 28 with higher scores indicating better QoL. Aficamten treatment effect on EQ-5D-5L was estimated using linear regression (study visits) and mixed effects regression (overall treatment effect) using all follow-up data with model adjustments for baseline EQ-5D-5L score and randomization stratification variables. Results: Mean age (n=282) was 59.1±12.9 years (40.8% women; 79.1% white). Aficamten baseline EQ-5D-5L index and VAS scores were 0.8±0.19 and 71.2±17.9 (placebo: 0.78±0.2; 68.9±18.6), respectively. Aficamten improved the EQ-5D-5L by 0.026 (95% CI: -0.001, 0.052; p=0.056) and the VAS by 2.8 points (95% CI: 0.8, 4.8; p=0.006) versus placebo with significant differences as early as 8 weeks after treatment initiation (p=0.005). After treatment withdrawal at 24 weeks, QoL benefits in aficamten-treated patients decreased compared with placebo (Figure: Index, p<0.001; VAS, p=0.003), with hemodynamic parameters returning to baseline. Conclusions: Aficamten yielded early, sustained and significant improvement in overall QoL compared with placebo. Withdrawal of aficamten was associated with the loss of treatment benefits and perhaps an increased perception of pre-treatment symptoms. These data support a role of aficamten in improving QoL among patients with oHCM.

Assessing Long-Term Quality of Life Concerns Through Survivorship Clinic in Head and Neck Cancer Patients.

To characterize the concerns of head and neck cancer (HNC) patients and discern changes in quality-of-life (QoL) during long-term follow-up. Retrospective review. Survivorship clinic at a tertiary academic center. A retrospective review was conducted on HNC patients seen in our survivorship clinic between 1/2020 and 1/2024 using the University of Washington Quality of Life (UW-QOL) Questionnaire. Three hundred and forty-two patients were seen for 914 encounters. Patients were divided into 4 groups: pretreatment (n = 326), 0 to 12 months posttreatment (n = 247), 1 to 3 years posttreatment (n = 248), and more than 3 years posttreatment (n = 64). The average follow-up after treatment was 459 days (range: 0-5.2 years). Multivariable analysis revealed significant improvements in overall QoL, health-related QoL, social-emotional composite scores, activity, anxiety, appearance, chewing, mood, pain, speech, and recreation at more than 1-year posttreatment compared to less than 1-year posttreatment. However, declines were noted in saliva and taste scores. No differences in scores were observed between patients 1 to 3 years posttreatment and those >3 years posttreatment. At all timepoints before and after treatment, top concerns were pain, activity, and swallowing. Patients with oral cancer followed for more than 1-year posttreatment had worse scores in appearance, chewing, pain, and speech compared to those with oropharyngeal cancer. Understanding the evolving concerns of HNC patients is imperative for enhancing care. Most QoL domains improve at 1-year posttreatment except for saliva, taste, swallowing, and shoulder function. QoL scores stabilize after 1-year post-treatment. Pain, activity, and swallowing remain the top concerns at all time points.

Abstract PO3-11-03: A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patient with Breast Cancer

Abstract Introduction: Quality of life (QoL) in oncology captures the well-being of a patient and is considered a significant outcome criterion. Breast cancer (BC) is the most diagnosed cancer in women, however, standardizing integrative therapies to alleviate the burden of cancer and improve QoL is still an unmet need. Art and music therapy might mitigate psychological and emotional distress. We sought to evaluate their efficacy compared to control among patients with BC during or after active therapy. Methods: Seventy-six treated patients with Stages I-III BC were randomly assigned to art, music therapy, or routine oncology care standard of care arm (SOC) for 3 months and received two sessions per month by a licensed therapist (including in-person/virtual and group sessions). The primary outcome was an improvement in QoL measured by the Functional Assessment of Cancer Therapy–Breast (FACT-B) questionnaire and secondary outcomes included: cognitive function measured by Functional Assessment of Cancer Therapy–Cognition (FACT-Cog), response to a 4-component Cleveland Clinic Visual Analog Scale (CCVAS), indicators of anxiety and depression assessed by the Generalized Anxiety Disorder-7 item (GAD-7) and Patient Health Questionnaire-9 item (PHQ-9). All questionnaires were assessed at baseline, 30, 90, and 180 days. Statistical considerations included stratified randomization, and a mean difference in 15 points between either of the interventions. SOC arm was considered relevant at the 3-month mark. Mean improvement within groups was performed using paired t-tests whereas independent t-tests were used to evaluate mean improvement between interventions (1 or 2 vs. SOC arm). All analyses were performed using SPSS version 26 (IBM, Armonk, NY). Results: Forty-five participants completed the study to date and were included in the interim analysis. Median age was 58 (57-59), white race (51.1%), patients on active treatment (45%), art therapy group (n=16), music therapy (n=15) and standard of care (n=14). Significant improvement was noted in the art therapy arm at 3 months in FACT-B physical well-being (p=0.04), functional well-being (p=0.008) domains as well as GAD-7 (p=0.003), PHQ-9 (p=0.04) and FACT-Cog section “impact on quality of life” (p=0.03). At 6 months, the art therapy arm demonstrated lower scores in the CCVAS questionnaire total score, emotional distress (p=0.01) and anxiety (p=0.004) scales. Music therapy participants reported a significant improvement only in GAD-7 index(p=0.04) at 3 and 6 months compared to SOC. No significant difference was found between art and music therapy arms. Conclusion: Art therapy patients exhibited significant improvement in overall QoL (including anxiety, depression, improvement in cognitive function) and 4-scale CCVAS (emotional distress, anxiety, depression, and pain). Music therapy improved anxiety scores (GAD-7). Art and music therapy should be considered in the care of patients to manage cancer associated distress and improve their quality of life. Table 1. Comparison of test changes from 3 months to baseline within groups Table 2. Comparison of test changes from 6 months to baseline within groups Citation Format: Maria Herran, Mohamed Mohanna, Saad Sabbagh, Barbara Dominguez, Kaylee Sarna, Rachel Upton-Rice, Angie Burdine, Zeina Nahleh. A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patient with Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-11-03.

Evaluation of Effectiveness of Sinus Surgery in Chronic Rhinosinusitis Patients using Sinonasal Outcome Index-22, modified Lund Mackay Score and Rhinosinusitis Disability Index

Functional endoscopic sinus surgery (FESS) is done in patients with chronic rhinosinusitis (CRS) not responding to medical therapy. This study aims to evaluate the subjective, objective and overall quality of life improvement in CRS patients following FESS surgery. Sinonasal outcome index-22, modified Lund-Mackay score and Rhinosinusitis Disability Index were used to evaluate subjective, objective and overall quality of life in patients with CRS. The questionnaires were asked before the surgery and three months after surgery. A total of 110 patients were enrolled in the study. All three types of evaluation showed improvement following FESS surgery. FESS in CRS patients refractory to medical management caused significant improvement in symptom intensity, endoscopic score and overall quality of life.

Hybrid total alloplastic temporomandibular joint replacement prosthesis: a pilot study to evaluate feasibility, functional performance and impact on post-operative quality of life.

The aim of the present study was to investigate the clinical efficiency of hybrid alloplastic temporomandibular joint (TMJ) prosthesis in patients undergoing TMJ total alloplastic joint replacement (TMJR). The prosthesis utilized for this study for TMJR is a hybrid variant with combination of stock prototype design and a partial customization of components. A prospective clinical study was conducted involving five patients with unilateral TMJ ankylosis or end-stage joint disease (ESJD) indicated for and requiring TMJR. The patients underwent resection of the joint or gap arthroplasty followed by TMJR using the hybrid alloplastic TMJ prosthesis. The subjective and objective variables that included the jaw function (JF), inter-incisal opening (IO), diet intake (DI) and quality of life (QoL) were assessed using the psychometric modified Likert scale. The nutritional status of the patients was evaluated using the mid-upper arm circumference (MUAC) as reference. The assessed study variables demonstrated functional and observational improvement in the post-operative follow-up when compared to the pre-operative period. The patients showed an improvement in overall QoL and nutritional status post-operatively. The follow-up period showed subjective and objective improvement in the parameters assessed among the study population. There is a technical and clinical feasibility to utilize the hybrid alloplastic TMJ prosthesis as a reliable alloplastic option for treating patients requiring TMJR, with prudent indications.

Efficacy of the Enteroadsorbent Silicol®gel in Adults with Irritable Bowel Syndrome Subtypes IBS-D or Mixed: Observational Open-Label Study.

Irritable bowel syndrome (IBS) is a common chronic gut-brain interaction disorder with limited effective treatment options. Intestinal adsorbents have a high adsorption capacity for gut irritants and may provide nonpharmacological alternatives. This post marketing study is aimed at providing up-to-date evidence to support the safety and efficacy in normal use of an established medical device for IBS treatment. In this open-label, observational study, adults with IBS with predominant diarrhoea (IBS-D) or IBS with mixed bowel habits (IBS-M), according to Rome IV criteria, received 4 weeks of treatment with the enteroadsorbent Silicol®gel, a CE-certified, licenced, medical device containing colloidal silicic acid. Eligible participants were assessed at baseline (visit 1; in-clinic) and after 1 (visit 2; telephone), 2 (visit 3; telephone), and 4 (visit 4; in-clinic) weeks of treatment. The primary endpoint was the proportion of participants with an overall reduction in the IBS severity scoring system (IBS SSS) > 50, representing clinically meaningful improvement. Key secondary endpoints were a reduction in common IBS symptoms and improved quality of life (QoL). Among the 67 treated participants (IBS-D: 37; IBS-M: 30), 65 completed the study. At visit 4, 83.6% (56/67) of participants achieved a reduction in IBS SSS > 50. The mean (standard deviation [SD]) IBS SSS was 323.4 (55.7) at visit 1 and 160.3 (90.3) at visit 4 (overall change: -163.1 (101.7); 95% confidence interval [CI] 138.3, 187.9, p < 0.001). Compared with visit 1, significant reductions in the severity of all key IBS symptoms and overall improvement in QoL were observed at visit 4 (p < 0.001), with improvements observed from visits 1 and 2. In this open-label study of participants with IBS-D and IBS-M, Silicol®gel provided clinically significant improvement in IBS symptoms, demonstrating that enteroadsorbents may be clinically beneficial in this population.

Functional Recovery of COVID-19 Patients Admitted to a Cardiopulmonary Inpatient Rehabilitation Unit

Introduction: With changes in treatments, precautions, and the virus itself, the continued evaluation of post-COVID-19 patient rehabilitation needs is essential. Methods: Demographics, comorbidities, functional assessments, quality of life, and rehabilitation outcomes for 98 patients admitted to inpatient rehabilitation during New York’s most recent major COVID-19 hospitalization surge were analyzed. Patients were contacted at 6 months to evaluate functional improvement, post-COVID-19 symptoms, vaccination status, and quality of life. Results: Inpatient rehabilitation addressed significant limitations in lung capacity, mobility, and self-care. Median mobility scores improved significantly from admission (16) to discharge (34) and follow-up (42). Sixty-six percent of patients reported overall quality of life improvement during their rehabilitation stay; at follow-up, a more modest percentage (35%) reported additional gains. Continued improvement in supplemental oxygen use was observed in 49% of patients who completed the follow-up assessment. Consistent with previous studies on severe disease, post-COVID-19 condition features were exhibited by 86% of patients at follow-up; vaccinated individuals displayed fewer symptoms associated with post-COVID-19 condition than their unvaccinated counterparts. Conclusions: Individuals recovering from severe COVID-19, including previously ventilated patients, made significant functional and quality of life gains during inpatient rehabilitation. While functional independence continued to improve post-discharge, patients exhibited greater improvement from admission to discharge than from discharge to 6-month follow-up. Inpatient rehabilitation represents a crucial component for recovery from severe COVID-19.

Yoga vs. behavioral placebo for fatigue and quality of life among older cancer survivors.

12023 Background: Older cancer survivors consistently express the need for interventions to reduce fatigue and maintain quality of life (QOL). We previously showed that yoga, compared to standard care, effectively improved fatigue and QOL among older survivors. Whether yoga is superior to a rigorous behavioral placebo for improving fatigue and QOL in older survivors is unknown. To examine the efficacy of yoga vs a behavioral placebo for improving fatigue and QOL in older survivors. Methods: Older cancer survivors (age 60+) 2-60 months post-treatment were randomized to receive Yoga for Cancer Survivors (YOCAS; 75-minute sessions 2x/week for 4 weeks) or a behavioral placebo (Survivorship Health Education – SHE; 75-minute sessions 2x/week for 4 weeks). The YOCAS intervention includes breathing exercises, yoga poses, and mindfulness activities. The SHE placebo includes education based on ASCO cancer survivorship recommendations. Fatigue and QOL (i.e., overall, physical, emotional, and functional) were assessed pre- and post-intervention with the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). The within-group and between-group intervention effects on fatigue were examined by 2-tailed t tests and ANCOVAs. Results: 173 older survivors were enrolled (91% women, mean age 67 [range=60-85], 90% White, 10% racial minority, 2.3% Hispanic, 71% breast cancer). On average, participants completed 6 in-person yoga sessions and 1 additional weekly, home-based yoga practice, for an average of 183 minutes of yoga/week with no intervention-related adverse events. There were significant between group differences on fatigue, where yoga participants reported significantly more improvement in fatigue than controls (1.6±0.9, p&lt;0.05). There were also significant between group differences on the emotional component of QOL, where yoga participants reported significant improvement in the emotional component of QOL but controls did not (0.8±0.4, p&lt;0.045). Moreover, there were statistical trends for between group differences on the physical and functional component of QOL, where yoga participants reported improvements in the physical (0.8±0.4, p&lt;0.063) and functional components of QOL (0.9±0.5, p&lt;0.089) but controls did not. There were significant between group differences on overall QOL, where yoga participants reported significant improvement in overall QOL but controls did not (3.8±1.4, p&lt;0.007). 94% of participants reported the intervention useful for symptom management and would recommend it to others. Conclusions: Results suggest that older survivors: 1) can safely utilize yoga for treating side effects, 2) experience improvements in fatigue and QOL via yoga therapy, and 3) find yoga a useful treatment for side effects and recommend it to others. Future research is needed to confirm these results and increase uptake by older, and ethnically and racially diverse survivors. Clinical trial information: NCT02613364 .

A phase III randomized controlled trial of a stepped collaborative care intervention versus standard of care.

e24191 Background: The aims of this study were to screen patients for symptoms of depression, pain, and/or fatigue and test the efficacy of a stepped collaborative care (SCC) intervention compared to standard of care (SC). When compared to SC, we expected that the patients randomized to the SCC intervention would report greater improvements in patient quality of life (QoL) and lower health care utilization and costs. Family caregivers, of patients randomized to the SCC, were expected to have lower risk of cardiovascular disease when compared to family caregivers, of patients randomized to SC. Methods: Of the 459 patients and 211 caregivers enrolled in this trial, patients’ mean age was 66 years, the majority were female (56.2%) and Caucasian (92.6%). Family caregivers had a mean age of 62 years, the majority were female (69%) and Caucasian (87%). Patients were screened for clinical levels of depression, pain, and/or fatigue and then were randomized to the SCC intervention or SC arm (referral to a community provider for treatment). Family caregivers were administered questionnaires and provided blood and anthropometric data to assess risk of CVD using the ASCVD calculator. Family caregivers did not receive the intervention. Health care utilization was collected from the patients' medical record and activity-based costs were used to assess health care savings. Intent to treat analyses using general linear mixed models were employed to test the hypotheses. Results: General linear mixed models revealed an interaction of quadratic time by arm effect with patients who were randomized to the SCC intervention having greater 0-to-6-month improvement in overall QoL versus patients randomized to the SC arm [t(579) = 2.23, p = .0259]. No group difference was observed in 6-to-12 month change in QoL suggesting maintenance of gains were observed at 12 months [t(561) = -1.34, p &gt; .10]. Multivariate analyses showed a similar pattern of more rapid gains in the subscales of QoL at 6-months in the patients randomized to the SCC intervention when compared to patients in the SC arm on the emotional well-being [t(1,856) = 2.27, p = 0.012], functional well-being [t(1, 891) = 1.73, p = 0.042]; and physical well-being subscales [t(1,777) = 1.84, p = 0.033]. Family caregivers, of patients who were randomly assigned to the SCC intervention, had lower lifetime cardiovascular risk, when compared family caregivers of patients who were randomized to the SC (uMV χ2 =9.00, p = 0.027). Activity based costs savings of $12,546 per patient per year in activity-based costs were observed for patients randomized to the SCC intervention versus SC. The drivers of the activity-based cost savings appear to be reductions in complication and readmission rates. Conclusions: Cancer centers, and payors, interested in novel delivery and payment models may consider this integrated strategy to improve patient quality of life and save health care costs. Clinical trial information: NCT02944136 .

Cognitive decline and quality of life after resective epilepsy surgery

ObjectivesThe objectives of this study were to examine the association between cognitive decline and quality of life (QoL) change in a large sample of individuals with drug-resistant epilepsy who underwent resective surgery and to examine whether the association between cognitive decline and QoL is differentially affected by seizure classification outcome (Engel Class 1 vs. 2–4) or side of surgery (left vs. right hemisphere). Materials and methodsThe sample comprised 224 adults (ages ≥ 18) with drug-resistant focal epilepsy treated with resective surgery who underwent comprehensive pre-operative and post-operative evaluations including neuropsychological testing and the Quality of Life in Epilepsy Inventory - 31 between 1991 and 2020. Linear mixed-effects models were fit to examine subject-specific trajectories and assess the effects of time (pre- to post-operative), cognitive decline (number of measures that meaningfully declined), and the interaction between time and cognitive decline on pre- to post-operative change in QoL. ResultsIncreases in QoL following resection were observed (B = −10.72 [SE = 1.22], p < .001; mean difference between time point 1 and time point 2 QoL rating = 8.11). There was also a main effect of cognitive decline on QoL (B = −.85 [SE = .27], p = .002). Follow-up analyses showed that the number of cognitive measures that declined was significantly associated with post-surgical QoL, (r = −.20 p = .003), but not pre-surgical QoL, (r = −.04 p = .594), and with pre-to post-surgery raw change in QoL score, (r = −.18 p = .009). A cognitive decline by time point interaction was observed, such that those who had greater cognitive decline had less improvement in overall QoL following resection (B = .72 [SE = .27], p = .009). Similar results were observed within the Engel Class 1 outcome subgroup. However, within the Engel Class 2–4 outcome subgroup, QoL improved following resection, but there was no main effect of cognitive decline or interaction between cognitive decline and time point on QoL change. There was no main effect of resection hemisphere on overall QoL, nor were there interactions with hemisphere by time, hemisphere by cognitive decline, or hemisphere by time by cognitive decline. ConclusionsQuality of life improves following epilepsy surgery. Participants who had cognitive decline across a greater number of measures experienced less improvement in QoL post-operatively overall, but there was no clear pattern of domain-specific cognitive decline associated with change in QoL. Our results indicate that cognitive decline in a diffuse set of cognitive domains negatively influences post-operative QoL, particularly for those who experience good seizure outcomes (i.e., seizure freedom), regardless of the site or side of resection.

Longitudinal Trajectory and Predictors of Health-Related Quality of Life after First-Episode, Acute Onset Venous Thromboembolism in Children

Background/objectives: We prospectively measured change in the quality of life (QOL) in children during the 2 years after first-episode, acute venous thromboembolism (VTE) and evaluated predictors of QOL, including the impact of post-thrombotic sequelae on QOL. Patients/methods: Consecutive patients with acute VTE were recruited from 2016 to 2022 for the TOP (Thrombosis Outcomes in Pediatrics) study (ClinicalTrials.GOV ID: NCT03068923). A pre-planned QOL analysis was conducted at study visits at diagnosis and 3, 6, 12, 18, and 24 months. Patients with cancer, recurrent VTE, sickle cell disease, and those not anticoagulated were excluded. At each visit, a standardized assessment for post-thrombotic sequelae (recurrence, post-thrombotic syndrome (PTS), post-pulmonary embolism (PE) syndrome, portal HTN, and post-CSVT recovery) was performed, and participants self-completed QOL questionnaires using the Peds QoL. Mean within-patient change scores (baseline to 2 years) were assessed using paired t-tests (Hο: Δ = 0), where positive change scores indicate improvement in QOL. Change in QOL over time was assessed in the entire cohort and was compared between patients with and without adverse post-thrombotic sequelae. Predictors of QOL were evaluated, and the influence of post-thrombotic sequelae on QOL at two years was assessed using multivariable regression analyses. Results: Among the 120 children prospectively recruited, the median age was 13 years (range 0-18). 56% were males (n=66) and 28% were Hispanics. The most common VTE site was lower extremity DVT (41%), and 80 % had a provoked event. 15% had comorbidities. The cumulative incidence of adverse post-VTE outcomes at 2 years was 26% (10 children within the entire cohort developed recurrence identified objectively, 5 of 67 with extremity thrombosis had clinically significant PTS as assessed with the Manco-Johnson Instrument instruments, 9 of 36 with PE had post-PE exercise intolerance on cardiopulmonary exercise testing, 2 of 9 with portal vein thrombosis developed portal HTN and 4 of 23 with CSVT had impaired neurocognitive recovery measured by the pediatric stroke recurrence and recovery questionnaire). QOL scores below the population mean were documented at diagnosis (32%), 3 (37%), 6 (20%),12 (23%), 18 (19%) and 24 (13%) months. On average, QOL scores improved during follow-up, with most improvement occurring in the first six months following post-diagnosis. However, patients who developed adverse post-thrombotic sequelae had lower scores at all visits and significantly less improvement in QOL over time. Multivariable regression analyses showed that female sex (p=0.01), non-extremity thrombosis (p=0.008), presence of post-thrombotic sequelae (p=<0.001) and long-term anticoagulation (p=<0.001) independently predicted 2-year post-diagnosis impaired QOL. Conclusions: We evaluated QOL during the 2 years following an episode of acute We found that, on average, QOL scores tended to improve during follow-up and that most of the improvement in QOL occurred in the first 6 months after VTE. However, patients who developed post-thrombotic sequelae had poorer QOL, less overall improvement in QOL, and slower improvement in QOL. Our findings are of direct importance to patients. On average, patients with VTE who do not develop post-thrombotic sequelae can expect that at 2 years, their QOL will improve to a level like that of the general population. Further, our study provides prognostic information on patient-reported outcomes after VTE and emphasizes the need for effective prevention and treatment of the post-thrombotic sequelae. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

282 SELF-REPORTED QUALITY OF LIFE IN PATIENTS COMPLETING A GERIATRIC REHABILITATION PROGRAM

Abstract Background Geriatric Rehabilitation (GR) delivers person-centered care focused on achieving self-determined goals. While there is evidence for significant physical gain during GR, there is a paucity of articles describing its effect on self-reported Quality-of-Life (QoL). This study aims to ascertain the effect of GR on QoL and to assess whether positive effects persist even if patients do not achieve functional independence. Methods A retrospective review was conducted using Microsoft Excel spreadsheet data that is routinely collected for service evaluation purposes. All patients with complete data sets in 2021 were included. Barthel Index (BI) which quantifies functional independence and EQ5D which measures QoL were collected on admission and discharge. Both measures are scored out of one hundred, with higher scores indicating more positive results. Patients were divided into two groups based on BI at discharge (BI&amp;gt;90 and BI&amp;lt;90) and outcomes were analysed using t-tests. Results Among 122 patients, the mean age was 80 (range 64-96) and 50 (41%) were male. 68 patients (56%) had a BI&amp;gt;90 at discharge and 54 (44%) had a BI&amp;lt;90. Those with a BI&amp;lt;90 reported an overall improvement in QoL after GR (45 vs 68, p&amp;lt;0.0001), similar to those who achieved a BI&amp;gt;90 (55 vs 80, p&amp;lt;0.0001). However, those with BI&amp;gt;90 rated their QOL higher than those with a BI&amp;lt;90 (80 vs 68, p=0.008). Higher pre-morbid frailty level, fear of falling, and having delirium during GR were all significantly associated with worse outcomes (BI&amp;lt;90) at discharge. Conclusion This study demonstrates that GR improves self-reported QOL regardless of improvement in functional independence. Positive effects of GR have potential to extend beyond physical function, addressing other issues such as sarcopenia and fear of falling which improve QOL. Individually tailored GR programs should be considered for all older persons experiencing functional decline after hospitalisation or in the community.

Quality-of-Life Assessment after Head and Neck Oncological Surgery for Advanced-Stage Tumours.

Squamous cell carcinoma of the head and neck (HNSCC) is a common malignancy often diagnosed in the advanced stage with a complex negative influence on the patient’s quality of life (QoL). Given its multi-modal treatment, the first step is to adequately balance the needs of the patient, and the second step includes the consultations, interventions, and care provided by the medical team, with the purpose of improving the overall management of the HNSCC. Current attempts to develop and validate quality-of-life instruments specific to cancers of the head and neck have been reported, and certain questionnaires are now available. We performed a retrospective study in a tertiary centre, involving 89 patients who survived 3 years after HNSCC surgery. A patient-related outcome measurement was made using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-H&N35 instruments to assess QoL at admission and 3 years after treatment. The 3-year survivors reported an overall improvement in QoL compared with those in the pre-treatment period. The unique details of head and neck cancer treatments outline the importance of considering the characteristics of the patient population in quality-of-life research and also identify how quality-of-life data can contribute to the care provided by the multi-disciplinary team involved in a patient’s follow-up.

Quality of life and secondary outcomes for open versus robot-assisted radical cystectomy: a double-blinded, randomised feasibility trial.

This study aims to examine quality of life (QoL) before and after radical cystectomy (RC) and compare robot-assisted laparoscopy with intracorporeal urinary diversion (iRARC) to open radical cystectomy (ORC). This study is a predefined secondary analysis of a single-centre, double-blinded, randomised feasibility trial. Fifty patients were randomly assigned to iRARC with ileal conduit (n = 25) or ORC with ileal conduit (n = 25). Patients were followed 90days postoperatively. The primary outcome was patient-reported QoL using the EORTC Cancer-30 and muscle-invasive bladder cancer BLM-30 QoL questionnaires before and after RC. Differences between randomisation arms as well as changes over time were evaluated. Secondary outcomes included 30- and 90day complication rates, 90day readmission rates, and 90day days-alive-and-out-of-hospital and their relationship to QoL. All patients underwent the allocated treatment. We found no difference in QoL, complication rates, readmission rates, and days-alive-and-out-of-hospital between randomisation arms. An overall improvement in QoL was found in the following domains: future perspectives, emotional functioning, and social functioning. Sexual functioning worsened postoperatively. There was no association between having experienced a major complication or lengthy hospitalisation and worse postoperative QoL. The QoL does not appear to depend on surgical technique. Apart from sexual functioning, patients report stable or improved QoL within the first 90 postoperative days.

Fluctuations in quality of life and immune responses during intravenous immunoglobulin infusion cycles

Despite adequate infection prophylaxis, variation in self-reported quality of life (QOL) throughout the intravenous immunoglobulin (IVIG) infusion cycle is a widely reported but infrequently studied phenomenon. To better understand this phenomenon, subjects with humoral immunodeficiency receiving replacement doses of IVIG were studied over 3 infusion cycles. Questionnaire data from 6 time points spread over 3 IVIG infusions cycles (infusion day and 7 days after each infusion) were collected in conjunction with monitoring the blood for number of regulatory T-cells (Treg) and levels of 40 secreted analytes: primarily cytokines, chemokines, and growth factors. At day 7, self-reported well-being increased, and self-reported fatigue decreased, reflecting an overall improvement in QOL 7 days after infusion. Over the same period, percentage of Treg cells in the blood increased (p<0.01). Multiple inflammatory chemokine and cytokine levels increased in the blood by 1 hour after infusion (CCL4 (MIP-1b), CCL3 (MIP-1a), CCL2 (MCP-1), TNF-α, granzyme B, IL-10, IL-1RA, IL-8, IL-6, GM-CSF, and IFN- γ). The largest changes in analytes occurred in subjects initiated on IVIG during the study. A significant decrease in IL-25 (IL-17E) following infusion was seen in most intervals among subjects already receiving regular infusions prior to study entry. These findings reveal several short-term effects of IVIG given in replacement doses to patients with humoral immunodeficiency: QOL consistently improves in the first week of infusion, levels of a collection of monocyte-associated cytokines increase immediately after infusion whereas IL-25 levels decrease, and Treg levels increase. Moreover, patients that are new to IVIG experience more significant fluctuations in cytokine levels than those receiving it regularly.

Effectiveness of lifestyle modification on quality of life among uncontrolled diabetics and hypertensives in India - Community based intervention study.

Background:Diabetes and hypertension contribute to more than half of morbidity, mortality and years lived with disability in developing countries like India. It impacts the quality of life (QoL) of patients and their family. Management of these diseases is in infancy and emphasis is laid on pharmacological interventions. Though nonpharmacological measures are crucial for management, their implementation is questionable. Hence, this study was conducted to measure the effectiveness of lifestyle modifications on QoL among uncontrolled hypertensives and diabetics in rural India.Methods:An interventional study was done in 3 villages with 100 participants each, where village one received lifestyle modification as intervention and village two physical activity and village three control receiving standard care. The baseline data included socio-demographic characteristics such as awareness of hypertension, diabetes, lifestyle pattern and physical activity, and WHO QoL. The participants were trained, followed up, and assessed after 12 months following intervention. QoL scores between groups and pre- and post-intervention in the group were compared using Mann–Whitney U and Wilcoxon signed-rank test, respectively.Results:In this study, there was a significant improvement in overall QoL and in all the four domains, namely physical, psychological, social relationship, and environmental domains in both the intervention villages. QoL was significantly better in both the intervention groups following intervention than compared to the control group.Conclusions:QoL improves with intervention on uncontrolled diabetics and hypertensives. It is time to emphasize on the collaboration among physicians and on the holistic integrative health services delivery for non-communicable diseases.

WATSU therapy for individuals with Parkinson's disease to improve quality of sleep and quality of life: A randomized controlled study

Backgroundand Purpose: Sleep disorders are one of the most frequent non-motor symptoms of Parkinson's disease (PD). This study aimed to verify whether adding WATSU to land-based therapy leads to additional beneficial therapeutic effects regarding quality of sleep and quality of life (QOL) in individuals with PD. Materials & methodsA randomized control trial design was used. Participants completed nine-week interventions. The control group (CG) received land-based therapy, while the intervention group (IG) received the same land-based therapy and additionally WATSU. Sleep quality and QOL were measured at baseline and post-interventions by Pittsburgh Sleep Quality Index and Nottingham Health Profile, respectively. ResultsTwenty-eight participants completed the study. In contrast to CG, the IG presented with significant improvements in both, quality of sleep and QOL (p < 0.001). ConclusionWATSU has the potential to be an attractive adjunct therapy for producing positive health impacts regarding sleep quality, which may translate to an overall improvement in QOL of individuals with PD.

Effect of Ketogenic Diet on Quality of Life in Adults with Chronic Disease: A Systematic Review of Randomized Controlled Trials.

Background: Chronic diseases adversely affect quality of life (QOL). The ketogenic diet (KD) may improve the QOL. Objective: The aim of this systematic review was to summarize the available evidence of randomized controlled trials (RCTs) to establish the effect of KD on the QOL in adults with chronic diseases. Methods: Reporting followed PRISMA guidelines. We included randomized controlled trials (RCTs) conducted on adults with chronic disease including an intervention group that received KD and a control group, and where QOL was reported as outcome. We searched PubMed, APA PsycInfo, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, and Clinicaltrials.gov, and the references of the included articles and previous relevant reviews, without language or time restrictions. We critically appraised included studies and narratively synthesized their findings. Results: Nine RCTs were included. The risk of bias was low, except of allocation concealment and blinding. In patients with cancer: one RCT found an improvement in overall QOL, another reported improved physical component summary, and one found no superiority of KD in all QOL domains. In patients with neurological disorders: improved QOL was reported in Alzheimer’s disease patients, whereas no difference in mental and physical health QOL was noted in patients with multiple sclerosis. In patients with obesity and type II diabetes: one RCT reported superiority of energy-restricted KD in improving role functioning, mental health, health perceptions, and pain compared with guideline-based diet, whereas in another RCT, high and low carbohydrate diets achieved comparable improvements. Among patients with knee osteoarthritis, no differences between KD and low-fat groups were noted. Dietary compliance with the KD, reported in three studies, was shown to be high. Side effects were mostly noted during the first weeks of intervention, and adverse events were not markedly different with KD and the comparison diet. Conclusions: The evidence from RCTs investigating the effect of KD on QOL in adults with chronic disease is inconclusive. The promising effect noted in some included studies and the low rates of adverse events and side effects encourage future investigations in this regard.

Syndromic Craniosynostosis: Objective and Parent-Reported Outcome Measurements after Cranio-Facial Remodelling Surgeries

Introduction: Syndromic craniosynostosis (SC) is a rare entity compared to the non-syndromic variant. Treatment involves a multidisciplinary approach towards a multitude of problems. Early intervention is known to be better for optimum results. We reviewed outcomes of children with SC who underwent reconstructive cranio-facial surgery. Materials and Methods: A retrospective study was conducted using data from hospital case files and the picture archival communication system. Objective data like the cephalic index (CI), both preoperatively and post-operatively, were compared. Subjective data for the cosmesis outcome – “Sloan and Whitaker outcome class” – following surgery were assessed. Also, parent-reported outcome measurement (PROM) was performed with various parameters to assess quality of life (QOL). Results: We had 21 operated cases of SC, with 19 needing cranio-facial remodelling. The male to female ratio was 11:10. Crouzon’s syndrome was the most common syndromic association followed by Apert’s syndrome. Nineteen patients underwent cranio-facial remodelling surgeries and 2 underwent the ventriculo-peritoneal shunt only – for raised intracranial pressure (ICP). Nine patients underwent cranial remodelling with fronto-orbital advancements, and 3 of these patients also received le-fort’s type 3 osteotomy and advancement later. Ten patients underwent fronto-orbital advancement with parieto-occipital barrel-stave osteotomies. Outcomes: Improvement in the CI was maximum at the 6-month follow-up. Six (37.5%) cases had Sloan class 1 outcome, 9 (56.25%) had class 2 outcomes, and 1 patient had a class 6 outcome. Whitaker cosmesis outcomes – 14 out of 16 cases (87.5%) had Category 1 outcomes. PROM was assessed. All parents reported at least a moderate improvement in cosmesis following surgery. Out of 15 cases, 10 (66%) reported significant improvement, while 4 (26.6%) cases reported moderate improvement with respect to eye and visual problems. Four parents reported snoring as a significant problem even after surgery. Most parents felt that the children were doing well, attending regular school, and social well-being was normal and had an overall good QOL. Conclusions: SC cases may have a multitude of other problems like raised ICP, ophthalmological problems, poor intelligence, and cognition apart from cosmetic concerns. PROMs revealed good outcomes in terms of cosmesis, cognition, and ophthalmological and oral cavity-related problems. Significant improvement in overall QOL was seen in most patients following cranio-facial remodelling surgery.

Quality of life assessment after parathyroidectomy in symptomatic primary hyperparathyroidism using the SF-36 questionnaire.

Primary hyperparathyroidism (PHPT) is a systemic disease which, along with bone and stone disease, also causes several subjective symptoms which impairs the quality of life (QoL). However, NIH guidelines do not include non-specific physical and neuropsychological symptoms as an indication of parathyroidectomy. SF-36 is one of the most commonly used tools for assessing QoL; it measures both physical health (PH) and mental health (MH). This is a prospective observational study including 50 patients of symptomatic PHPT. Patients were categorized into normocalcemia (8.5-10.4 mg/dL), mild hypercalcemia (10.5-11.9 mg/dL), moderate hypercalcemia (12-13.9 mg/dL), and severe hypercalcemia (>14 mg/dL). QoL was assessed by using SF36 survey both pre-operative and three months after parathyroidectomy. There was an overall improvement in QoL of individual groups both in PH and MH components (p <0.001). The improvement was more substantial for bodily pain, role physical, vitality and mental health. Although QoL was affected in patients with mild hypercalcemia, it was more affected in patients with severe hypercalcemia. The improvement in MH scores was dependent on the level of pre-operative calcium; however, the improvement in PH scores was independent of pre-operative calcium (p= 0.698). This study showed improvement in all aspects of PH and MH of SF-36 after parathyroidectomy, even in normocalcemics. Despite the fact that current guidelines for the management of PHPT do not include QoL as an indication for parathyroidectomy, we propose that parathyroidectomy should be considered, if patient is fit for surgery.