Improvement In Overall Health-related Quality Of Life Research Articles

The efficacy of a specifically designed printed material on satisfaction from information provision and Quality of Life of hematopoietic stem cell transplantation patients: A randomized controlled trial

Background: Patients with hematological malignancies who undergo hematopoietic stem cell transplantation (HSCT) face complex challenges and need appropriate information to help them cope with the physical and psychological demands of their treatment and experience greater health related quality of life (HRQoL). This study investigated the impact of a specially designed booklet about HSCT, on patients’ satisfaction from information, overall emotional distress and HRQoL. Method and Material: A total of 127 HSCT patients were randomly assigned to receive standard verbal information (control group, n=63) or the additional printed information (intervention group, n=64). Patients’ satisfaction was assessed at two time-points; at admission to the transplant unit and at discharge. Emotional distress and HRQoL were also evaluated at 3 and 6 months post-HSCT. Intention-to-treat analysis was performed. Results: Patients’ characteristics were similar in the two arms. The experimental group reported highest levels of satisfaction when compared with patients attending standard verbal approach (p<0.004). No significant differences between groups were noted, regarding patients’ desired attitude about the amount of perceived information. Overall, 65% of patients wanted all the available information. Most participants considered that the booklet was easy to read and helpful in recalling medical instructions. High levels of satisfaction were strongly correlated with reduction in anxiety levels and improvement in overall HRQoL, at discharge from the transplant unit. Conclusion: Our results demonstrate printed materials can be a beneficial and practical method for patients to gain comprehensible information for HSCT. However, further well-designed, longitudinal multicenter randomized trials are needed to confirm our findings.

#5622 DIALYSING THE ELDERLY: IMPACT ON THE PATIENTS’ HEALTH-RELATED QUALITY OF LIFE OUTCOME

Abstract Background and Aims The number of elderly who suffers from end stage renal disease (ESRD) is increasing and hence the dialysis therapy rate. Although dialysis increases life span, the overall benefits to elderly patients is arguably unpredictable due to the multiple comorbidities and functional impairment. Health-related quality of life (HRQOL) has been an important key outcome in the decision-making yet to date, there is no available local data of the dialysis implications on the elderly. Therefore, we aim to study on the impact of dialysis initiation on HRQOL among elderly ESRD patients. Method This is a prospective, multi-centered study conducted from 2021 to 2022 among elderly patients (aged ≥65) who were initiated on maintenance dialysis therapy. Health-related quality of life (QOL) were assessed using Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire within the first month of initiation (baseline) with a follow-up review performed after six months. Results The study included 29 patients with the oldest was 95 years old. 27 patients underwent haemodialysis (HD) and another 2 had peritoneal dialysis (PD). 12 (42%) of them required caregivers with 8 of them had limited mobilization. All of the patients had underlying comorbidities with 25 of them had 3 and more comorbidities. Majority of the patients (n=24) were diabetic with 13 of them had an underlying ischemic heart disease. Their mean baseline haemoglobin and albumin were 8.1 g/dL (±0.3) and 34.2 mmol/L (±1.3) respectively. Only 1 of the study patients was initiated HD via a fistula while the rest were using temporary catheter. At 6 months of follow-up, 5 of the patients died due to cardiovascular events, catheter-related sepsis and one of them resorted to palliative care due to exhausted conventional vascular access. 13 patients out of 22 remained on catheter for HD with 9 patients were still using temporary catheter. We observed improvement in all five domains of HRQOL assessed. The mean score of physical component summary was 33.00% (±10.58) at baseline and 41.22% (±9.54) after 6 months (P = .011). The mean scores for mental component at baseline and 6-month review were 45.53% (±14.78) and 52.95% (±10.57) respectively (p= 0.018). As for symptoms and problems domain, they initially scored 58.59% (±18.71) which increased to 76.61% (±16.05) after 6 months (P = .003). The scores for ‘burden of kidney disease’ and ‘effects of kidney disease’ domains were and 43.49% (±35.62) and 58.21% (±26.74) respectively at baseline with improvements to 58.85% (±31.81) (P = .026) and 76.04% (±24.65) (P = .008) after 6 months. Conclusion Our study showed that dialysis therapy results in significant overall improvement in HRQOL among elderly ESRD patients. The decision for dialysis among this group of patients is nonetheless a complex process with consideration made on individual basis followed by continuous evaluation of its effectiveness, incorporating HRQOL assessment tool in particular.

Health-Related Quality of Life of Patients with Metastatic Pancreatic Cancer: A Systematic Literature Review.

Metastatic pancreatic cancer (mPaC) has a poor prognosis and available treatments provide only moderate improvements in survival. Preserving or improving health-related quality of life (HRQoL) is therefore an important treatment outcome for patients with mPaC. This systematic review identified HRQoL data in patients with mPaC before and after treatment, compared these with data from the general population, and reported the effects of different mPaC treatments on HRQoL. Searches were performed in Embase, PubMed, and the Cochrane Library from January 2008 to May 2021, and the articles identified were screened for HRQoL data in patients with mPaC. Abstracts from relevant congresses were also manually searched. Publications included were randomized controlled trials and observational studies written in English that reported HRQoL data for adult patients with non-resectable mPaC who were on or off treatment. Thirty relevant publications were identified and HRQoL scores were collected. Overall, baseline mean scores from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), 5-dimension EuroQol questionnaire (EQ-5D), and Functional Assessment of Cancer Therapy-General (FACT-G) for newly diagnosed and previously treated patients with mPaC were worse than those of the general population. Baseline scores were generally better for previously treated patients than for newly diagnosed patients, indicating that mPaC treatments preserve or improve HRQoL. Identified publications also reported changes in HRQoL following first- or subsequent-line chemotherapy. When reported, 10 studies found improvements in overall HRQoL compared with baseline scores, four reported no changes in overall HRQoL after treatment, and six found deteriorations in overall HRQoL. Patients with mPaC had worse HRQoL than the general population. Available anti-cancer therapies can improve or preserve HRQoL.

Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Treated with Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D x CD3 Bispecific Antibody: Patient-Reported Outcomes from MonumenTAL-1

Introduction: Studies of multiple myeloma (MM) populations indicate that patients with more advanced and heavily pretreated disease have worse health-related quality of life (HRQoL) than those at earlier stages. In addition, treatment options are limited for triple-class exposed relapsed/refractory MM (RRMM), with little hope of improving HRQoL. Talquetamab is a first-in-class, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D and CD3 receptors. MonumenTAL-1 is a phase 1/2 trial (NCT03399799/NCT04634552) of talquetamab in patients with RRMM. Patient-reported outcomes (PROs) data on HRQoL, symptoms, and functioning were collected in the phase 2 cohorts of MonumenTAL-1. Here, we report PROs, focusing on global health status (GHS), physical functioning, pain, and fatigue, for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort. Data for the 0.8 mg/kg SC every 2 weeks (Q2W) cohort are immature currently. Methods. Patients enrolled in phase 2 must have previously received ≥3 prior lines of therapy, including ≥1 proteosome inhibitor, ≥1 immunomodulatory drug, and ≥1 anti-CD38 monoclonal antibody (ie, triple-class exposed). After screening, patients received talquetamab step-up doses, requiring hospitalization, before cycle 1. The European Organization for Research and Treatment of Cancer Quality of Life Core 30-item (EORTC QLQ-C30) questionnaire is a cancer-specific PRO instrument administered at screening, cycle 1, and then every other cycle. It includes a subscale to measure HRQoL, 5 functional scales, 3 symptom subscales, and 6 additional single items. Scores range from 0 to 100; higher scores indicate better GHS and functioning, whereas a higher score represents more symptom severity. Compliance with PROs was calculated as the number of completed assessments divided by the number of patients on study treatment at each assessment time point. Treatment effect was assessed with a mixed-effects model with repeated measures. For the analysis of the proportion of patients with meaningful improvement, the threshold for meaningful improvement from baseline was defined as a change of ≥10 points. Time to worsening was determined using the Kaplan-Meier estimate. Results: For patients treated with 0.4 mg/kg SC QW (n=122), compliance with completing the EORTC QLQ-C30 was 96% at screening and over 80% at most post-treatment visits. After an immediate decline in overall HRQoL between screening and cycle 1, patients reported meaningful improvements in EORTC QLQ-C30 GHS and a meaningful reduction in pain symptoms compared with baseline (Figure). Least squares [LS] mean change for fatigue symptoms was -8 (95% CI, -13.83, -2.26) at cycle 9 and reached a mean decrease (ie, improvement) of 11.2 points (95% CI, -18.9, -3.53) at cycle 13. Similar results were observed in the physical (LS mean change at cycle 9: 6.5 [95% CI, 2.05, 10.93]) and role (LS mean change at cycle 9: 11.4 [95% CI, 4.55, 18.25]) functioning subscales. With treatment, the proportion of patients with meaningful improvement was high; for example, at cycle 9 for the 0.4 mg/kg cohort, 42% improved in GHS, 34% in physical functioning, 40% in role functioning, 86% in pain symptoms, and 78% in fatigue symptoms. Median time to worsening ranged from 2 (role and social functioning) to 9 months (nausea/vomiting). Overall, changes in PROs were similar in the 0.8 mg/kg SC Q2W cohort in early cycles, but conclusions are limited due to short follow-up and small sample size. The 0.8 mg/kg SC Q2W cohort will be updated with additional follow-up. Conclusions: With talquetamab treatment, patients in the 0.4 mg/kg SC QW cohort reported improvement in overall HRQoL and physical and role functioning and a decrease in pain and fatigue. These findings are consistent with the clinical benefits of talquetamab as demonstrated by the efficacy results from the MonumenTAL-1 study. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial.

ObjectiveTo evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy.Patients and MethodsA prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months.ResultsThe participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were “satisfied” or “very satisfied” with the 10-kHz SCS treatment.ConclusionThe 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy.Trial registrationclincaltrials.gov Identifier: NCT03228420

The impact of extended half‐life factor concentrates on patient reported health outcome measures in persons with hemophilia A and hemophilia B

BackgroundRecombinant factors VIII and IX Fc (rFVIIIFc/rFIXFc) were the only available extended half‐life (EHL) products in Canada during 2016 to 2018. ObjectivesTo evaluate if patient‐reported outcome measures (PROMs) improved in Canadian persons with hemophilia who switched from standard half‐life (SHL) to EHL products (rFVIIIFc/rFIXFc). Patients/MethodsThis prospective cohort study enrolled persons with moderate or severe hemophilia aged ≥6 years who switched to rFVIIIFc/rFIXFc (2016‐2018) and those who remained on SHL. Health‐related quality of life (HRQoL) was assessed using the Haemophilia‐specific Quality of Life (Haem‐A‐QoL) and 36‐item Short‐Form Survey (SF‐36) at baseline, 3‐months, 12 months, and 24 months. Other PROMs included the Work Productivity and Impairment Questionnaire, chronic pain scale, partner/parent ratings of mood, International Physical Activity Questionnaire, and Treatment Satisfaction Questionnaire for Medication. We identified meaningful changes using minimally important difference for SF‐36 and responder definition for Haem‐A‐QoL. ResultsWe enrolled 25 switchers (16 rFVIIIFc, 9 rFIXFc) and 33 nonswitchers. Those switched to rFVIIIFc/rFIXFc had improved overall HRQoL, and improved subscale physical activity, mental health, and social functioning at 3 months. The rFIXFc switchers had improved chronic pain and ability to engage in normal activities while the rFVIIIFc switchers had improved treatment satisfaction. There was no change in work impairment after the switch. Observed improvement disappeared by 24 months in most domains. ConclusionSwitching from SHL to rFVIIIFc/rFIXFc resulted in short‐term meaningful improvement in overall HRQoL and other PROMs in a small proportion. Longitudinal changes on PROMs are affected by ceiling effects and response shift, warranting further studies in instrument optimization in the era of EHL and nonfactor products.

Measuring the Change in Health-Related Quality of Life in Patients Using Marijuana for Pain Relief

Introduction: Current evidence suggests that cannabinoids are safe with minimal side effects and are effective in managing chronic pain. Data also show that medical marijuana (MM) may improve quality of life (QoL) among patients. However, there are little data showing the health-related QoL (HRQoL) benefit in MM patients using it for pain. The purpose of this study was to determine if there is a relationship between HRQol and MM use in patients using it to relieve pain. Methods: All pain patients aged 18 years or older enrolled in the Pennsylvania MM program were eligible for inclusion. Recruited subjects completed 4 surveys – at enrollment (baseline) then 2, 4, and 8 weeks post-enrollment. We used the EQ-5D survey tool for measuring HRQoL. The primary outcome measure was the change in the EQ-5D Index Score from survey 2 to survey 4 (6 week difference). Secondary outcomes included self-reported pain and health scores. Data were analyzed using a paired t test and repeated-measures multivariable analysis to control for both gender and length of time between surveys. Results: 1,762 people responded to the screening request, and 1,393 (79%) met screening criteria. Of those, 353 (25.3%) agreed to participate and 51% completed all 4 surveys, for a final sample of 181 with 85 male and 95 female and one nonbinary subject. The average age was 41.21 (SD = 12.9) years, with no difference between genders. The adjusted HRQoL score improved from 0.722 to 0.747 (p = 0.011) from survey 2 to survey 4, as did the self-reported pain and health scores. The EQ-5D subscales revealed no change in mobility or usual activities, significant improvement in anxiety and pain, and a significant worsening in self-care. Conclusion: The results show a significant improvement in HRQoL among patients using MM for pain. The EQ-5D subscales validated the pain improvement and also showed an improvement in anxiety. However, the decline in the self-care subscale may have tempered the overall improvement in HRQoL, and further research into which aspects of self-care are impacted by MM use in this population is warranted. Overall, there is a positive relationship between MM use and HRQoL in patients using it for pain.

Impact of Expanded Hemodialysis Using Medium Cut-off Dialyzer on Quality of Life: Application of Dynamic Patient-Reported Outcome Measurement Tool

Rationale & ObjectiveCurrent hemodialysis (HD) treatments have limited ability to clear larger-molecular-weight uremic toxins. Retention is associated with increased symptom burden, low health-related quality of life (HRQoL), and high mortality. Improved clearance, using novel medium cut-off dialyzers, termed expanded HD (HDx), may be associated with improved subjective experience. We have previously developed a dynamic patient-reported outcome measure (PROM) instrument to allow iterative recording to better appreciate the overall burden of disease and assess the impact of therapy changes.Study DesignSingle-center interventional pilot study.Setting & Participants28 patients established on maintenance HD, London, Ontario, Canada.InterventionInitial study consisting of 2-week observation (baseline-conventional high-flux HD) followed by 12 weeks of HDx. HRQoL was assessed using the dynamic PROM instrument thrice weekly (enabled in a dedicated app as the London Evaluation of Illness [LEVIL]). Extension phase; 2-week baseline with 24 weeks of HDx and 8-week washout.OutcomesPrincipal aim was to establish whether HDx therapy was associated with improved HRQoL, evidence of dose-dependant response, and whether effects were durable over time, using LEVIL.ResultsPatients with lower LEVIL scores (<70/100) at baseline showed improvement in overall HRQoL after 8 weeks of therapy with similar carryover effect. General well-being, energy, and sleep quality were improved significantly as a consequence of HDx therapy. There were no detrimental effects of HDx detected in patients with higher baseline HRQoL.LimitationsSmall nonrandomized sample size. The coronavirus disease 2019 pandemic interfered with the extension phase.ConclusionsDynamic PROM assessment effectively identified patients with lower HRQoL and higher symptom burden, demonstrating durable time/dose-dependent improvements across a range of symptom domains. The use of this instrument may allow targeted selection of patients most likely to benefit from HDx therapy and assist in monitoring response and defining effect size and treatment duration to allow optimal design of further definitive randomized controlled trials of this newly introduced technology.FundingBaxter Healthcare Canada.Trial RegistrationClinicalTrials.gov ID: NCT03640858.

Early Clinical and Patient-Reported Outcomes of a New Hybrid Mesh for Incisional Hernia Repair

Consensus on the safety and efficacy of various types of mesh in reconstructing the abdomen has yet to be reached. Hybrid mesh products have been designed to address the need for a cost-effective mesh leveraging the tensile strength of a synthetic mesh while minimizing the prosthetic footprint within the abdominal wall through resorbable materials. In this study we evaluate early clinical outcomes and health related quality of life (HR-QOL) of a new Hybrid mesh, SynecorTM, for Ventral Hernia Repair (VHR). Adult (>18 y old) patients undergoing VHR with SynecorTM mesh by a single surgeon between 2017-2019 with ≥1-y follow-up were identified. We analyzed a composite of postoperative outcomes as well as the incidence of hernia recurrence, readmissions, mortality, and HR-QOL. Thirty-five patients were included in our analysis with a median follow up of 2.1 y. The median age and BMI were 54.1 y and 33.2 kg/m2, respectively. The rate of surgical site occurrences was 37.1%, with only one patient (2.9%) requiring surgical intervention. No patients developed a hernia recurrence. Overall HR-QOL improved significantly (preoperative mean 2.5 [SD 0.7] versus postoperative 3.4 [0.4]; P< 0.01), particularly in regards to pain, functional status, self-esteem and body image (all P < 0.05). Abdominal reinforcement with SynecorTM mesh at the time of VHR results in promising early recurrence rates, an acceptable safety risk profile, and an improvement in overall HR-QOL.

Physical, psychological and nutritional outcomes in a cohort of Irish patients with metastatic peritoneal malignancy scheduled for cytoreductive surgery (CRS) and heated intrapertioneal chemotherapy (HIPEC): An exploratory pilot study.

BackgroundTreatment for peritoneal malignancy (PM) can include cytoreductive surgery (CRS) and heated intrapertioneal chemotherapy (HIPEC) and is associated with morbidity and mortality. Physical, psychological and nutritional outcomes are important pre-operatively. The aim of this pilot study was to investigate these outcomes in patients with PM before and after CRS-HIPEC.MethodsBetween June 2018 and November 2019, participants were recruited to a single-centre study. Primary outcome was cardiopulmonary exercise testing (CPET) variables oxygen uptake (VO2) at anaerobic threshold (AT) and at peak. Secondary outcome measures were upper and lower body strength, health related quality of life (HRQoL) and the surgical fear questionnaire. Exploratory outcomes included body mass index, nutrient intake and post-operative outcome. All participants were asked to undertake assessments pre CRS-HIPEC and 12 weeks following the procedure.ResultsThirty-nine patients were screened, 38 were eligible and 16 were recruited. Ten female and 6 male, median (IQR) age 53 (42–63) years. Of the 16 patients recruited, 14 proceeded with CRS-HIPEC and 10 competed the follow up assessment at week 12. Pre-operative VO2 at AT and peak was 16.8 (13.7–18) ml.kg-1.min-1 and 22.2 (19.3–25.3) ml.kg-1.min-1, upper body strength was 25.9 (20.3–41.5) kg, lower body strength was 14 (10.4–20.3) sec, HRQoL (overall health status) was 72.5 (46.3–80) % whilst overall surgical fear was 39 (30.5–51). The VO2 at AT decreased significantly (p = 0.05) and HRQoL improved (p = 0.04) between pre and post- CRS-HIPEC. There were no significant differences for any of the other outcome measures.ConclusionThis pilot study showed a significant decrease in VO2 at AT and an improvement in overall HRQoL at the 12 week follow up. The findings will inform a larger study design to investigate a prehabilitation and rehabilitation cancer survivorship programme.

Health-Related Quality of Life in the Cartitude-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma

Health-Related Quality of Life in the Cartitude-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma

The Effect of Nature Based Environmental Education on the Health Related Quality of Life of Low Income Black and Hispanic Youth

The Effect of Nature-Based Environmental Education on the Health-Related Quality of Life of Low-Income Black and Hispanic YouthNadav Sprague1, Christine C. Ekenga11 Brown School, Washington University in St. Louis, St. Louis, MO 63130, USABackground: Urban, low-income, Black and Hispanic youth experience multiple health and educational disparities. These youth also experience disparities in nature contact, an environmental exposure that has been associated with enhanced physical and emotional well-being. Nature-based education (NBE) uses nature contact to promote healthy behaviors and academic success in youth. However, few studies have evaluated the health outcomes of NBE. In this prospective study, we evaluated the impact of NBE on the health-related quality of life (HRQoL) of low-income, urban Black and Hispanic youth.Methods: Participants were recruited from four schools in St. Louis, Missouri, USA. The sample consisted of 378 children, ages 9-15 years old, assigned to an intervention group or a school-matched control group. The 15-week intervention included weekly environmental in-class lessons and monthly nature-based trips. Study participants completed pre- and post-intervention questionnaires that included demographic questions and six validated HRQoL domains (Physical Health Functioning, Emotional Health Functioning, School Functioning, Social Functioning, Family Functioning, and overall HRQoL). Logistic regression models were used to evaluate the intervention’s influence on HRQoL.Results: Approximately 61% of the intervention group and 17% of the control group experienced a clinically significant improvement in overall HRQoL. After adjusting for age and past environmental education and nature-contact experiences before entering the intervention, the NBE intervention was associated with a clinically significant improvement in overall HRQoL (OR = 1.70, 95% CI = 1.01, 2.43).Conclusion: Nature-based education is a low-cost method for improving HRQoL and for low-income, urban, Black and Hispanic youth.

Seizure detection devices and health-related quality of life: A patient- and caregiver-centered evaluation

IntroductionThe unpredictability of epilepsy has a severe impact on health-related quality of life (HR-QOL) for people with epilepsy. Seizure detection devices have the potential to improve HR-QOL by improving seizure safety, reducing caregiver hypervigilance, and reducing seizure anxiety. Emerging data have led to an improved understanding of characteristics that promote acceptability of detection devices for people with epilepsy and caregivers. However, whether usage of seizure detection devices is associated with clinically meaningful improvement in anxiety and HR-QOL remains poorly understood. MethodsWe analyzed cross-sectional survey data collected first-hand from 371 people with epilepsy and caregivers on seizure detection device and HR-QOL using an enriched population of electronic seizure diary users. Metrics related to quality of life and anxiety reduction were compared between users and nonusers of seizure detection devices. ResultsCompared with nonusers of seizure detection devices, device users were significantly more likely to have been impacted by epilepsy in multiple HR-QOL domains, including anxiety, mood, emotional regulation/aggression, speech/language, sleep quality, social life, activities of daily living, independence, and education/academic potential. The majority (80.2%) of people using seizure detection devices experienced moderate or greater anxiety reduction from seizure detection device usage, while 11.1% reported that detection devices did not help at all with anxiety. Despite potential benefit, seizure detection devices were used only by a minority (21.8%) of people with epilepsy surveyed, and usage tended to be skewed toward younger patient age, higher income, and caregivers. There was no significant difference in overall HR-QOL between users and nonusers. ConclusionsSeizure detection devices provide moderate or greater anxiety reduction among the majority of people with epilepsy and their caregivers, but current translatability into improvements in overall HR-QOL may be limited. Affordability and technological support are potential barriers to maximizing benefit equally among the epilepsy community. These considerations may be useful to help guide future device development and inform patient–clinician discussions on device usage and HR-QOL.

Improvement of health-related quality of life in patients with overactive bladder syndrome: A subanalysis of the prospective, noninterventional study BELIEVE in the Greek population

Objective: The BELIEVE study is a prospective, noninterventional study which was conducted in a real-world setting in Europe and assessed quality of life, treatment satisfaction, healthcare resource utilization, and persistence with treatment in patients with overactive bladder (OAB) syndrome prescribed mirabegron as part of routine clinical practice. We present the results of a subanalysis of the BELIEVE study in the Greek population. Materials and Methods: The primary endpoint was change from baseline in quality of life (QoL) based on the OAB-questionnaire (OAB-q), consisting of the Symptom Bother Scale and health-related QoL (HRQoL). Change from baseline in QoL based on the EQ-5D-5 L health survey, treatment patterns and persistence with treatment, as well as adverse events during the study were also assessed. The duration of the observation period was 12 months. Results: A total of 97 OAB patients from 10 sites in Greece participated in the substudy; 89 completed the OAB-q at baseline and at least at one follow-up visit (Full Analysis Set, mean age 62.7 ± 10.9 years, 86.5% female). At baseline, 73% of patients were “new,” 14.6% were “lapsed,” 9% switched treatment, and 3.4% were on combination treatment. The scores in the Symptom Bother Scale and HRQoL Scale improved significantly from baseline at 10–12 months (−32.4 ± 2.54 and 30.2 ± 2.49, respectively). The EQ-5D subscales confirmed that mirabegron led to an improvement in the HRQoL of patients. At 10–12 months, 72% of patients were continuing on mirabegron treatment for OAB, either as single treatment (60%) or as combination treatment (12%). Mirabegron was well-tolerated, as no serious drug-related adverse events (AEs) were observed, whereas only a small percentage (6.2%) of drug-related AEs resulted in treatment discontinuation. Conclusions: The Greek population subanalysis confirmed the European results of the BELIEVE study. Patients who received mirabegron in a real-world setting showed clinically meaningful improvements in HRQoL. Mirabegron demonstrated a high persistence rate (72% at 12 months), and good tolerability. The overall improvement in HRQoL, particularly in the population continuing to receive mirabegron at 10–12 months, and the low incidence of AEs may have contributed to the high persistence rate.

Impact of Pathways Triple P on Pediatric Health-Related Quality of Life in Maltreated Children.

Child maltreatment is an adverse childhood experience associated with reductions in child well-being. This study examines whether an evidence-based parenting intervention delivered to families served by the child welfare system (CWS) affects pediatric health-related quality of life (HRQoL). This study is a randomized controlled trial of Pathways Triple P (PTP) delivered to families with open child welfare cases for child physical abuse or neglect (N = 119). Children were 5 to 11 years old and remained in the home after the investigation. The primary outcome measure for this study was the Pediatric Quality of Life Inventory (PedsQL) 4.0, which measures HRQoL across 4 subdomains: physical functioning, emotional functioning, social functioning, and school functioning. Child- and parent-reported PedsQL 4.0 was assessed at baseline and post-test after the 14-week intervention. Controlling for other factors, children in families randomly assigned to the PTP condition had a significant improvement in overall HRQoL after the intervention compared with families receiving usual services (βchild-report = 6.08, SE = 2.77, p = 0.03; βparent-report = 3.83, SE = 1.88, p = 0.04). Subdomain effect sizes differed when considering children's self-report or parents' proxy report. Children's self-report yielded the largest improvement in emotional functioning, whereas social functioning had the largest gain based on parents' proxy report. The PTP parenting intervention was associated with higher pediatric HRQoL as reported by both the child and parent. This intervention holds promise to improve child well-being when implemented in the CWS.

Effect of Lifestyle Intervention on Medical Treatment Cost and Health-Related Quality of Life in Type 2 Diabetes Mellitus Patients

Diabetes is a costly, lifestyle disorder which increases the burden of disease and deteriorates the Health-Related Quality of Life (HRQOL) of diabetes patients and this study was conducted to assess the effect of lifestyle intervention on medical treatment cost and HRQOL in type 2 diabetes mellitus (T2DM) patients. This quasi-experimental prospective study was conducted in Delhi Diabetes Research Center, New Delhi and included 224 T2DM patients. Patients were divided into LMC and usual care group on the basis of receiving or not receiving lifestyle modification counseling. The follow-up of both groups was done at 6th and 12th months. Collected data were analyzed through IBM, SPSS software v 21 for mean, median (min-max), SD, t-test and Wilcoxon scores (rank sums) test. The results of this study showed a statistically significant reduction in diabetes medication costs, hospitalization and surgery costs in the LMC group as compared to the usual care group. The significant improvement was also observed in HRQOL domains which includes - physical functioning (62.40±6.738 to 83.67 ± 5.4920), physical health (35.30±22.069 to 64.50±13.62), emotional problem (37.90±28.93 to71.46±16.75), energy (54.31±11.858 to 80.75 ± 15.52), emotional well-being (63.06± 9.828 to 85.79±6.36), social functioning (38.848±20.805 to 65.54±8.39) and general health (54.51±11.679 to 82.398± 11.7) at 12th month follow up in LMC group. The ADS score also showed significant improvement in overall HRQOL of LMC group. This study concludes that lifestyle intervention may improve HRQOL and reduce medical treatment cost of T2DM patients.

Health-Related Quality of Life after Allogeneic Hematopoietic Stem Cell Transplantation for Sickle Cell Disease

Sickle cell disease (SCD) is a hereditary hemoglobinopathy that affects over 100,000 people in the United States. Patients with SCD are known to experience suboptimal health-related quality of life (HRQoL). In addition to the physical manifestations of SCD, psychological and social stress, along with academic difficulties, secondary to the chronicity of the disease and its complications often affect patients with SCD. Although medical therapy of SCD has improved, allogeneic hematopoietic cell transplantation (allo-HCT) remains the only curative therapy. The objective of this study was to measure HRQoL before and after allo-HCT by assessing physical, psychological, and social functioning in patients with SCD who have undergone reduced-toxicity conditioning (busulfan/fludarabine/alemtuzumab) followed by allo-HCT. Patients < 21 years of age undergoing allo-HCT (matched siblings and unrelated donors) for SCD and their primary caregiver were enrolled using either the English or Spanish version of the PedsQoL 4.0. Data were collected at 3 time points: before allo-HCT and on days 180 and 365 after allo-HCT. The change in HRQoL from baseline was assessed with unadjusted and adjusted mixed-effects models in which subjects were treated as random effects, and variance component structure was used. Seventeen patients and 23 primary caregivers were enrolled and reported a mean overall HRQoL of 66.05 (SD, 15.62) and 72.20 (SD, 15.50) at baseline, respectively. In the patient-reported analysis with adjusted mixed-effects models, the estimated improvements in overall HRQoL were 4.45 (SE, 4.98; P = .380) and 16.58 (SE, 5.06; P = .003) at 180 and 365 days, respectively, after allo-HCT. For parent-reported overall HRQoL, the estimated improvements were 1.57 (SE, 4.82; P = .747) and 9.28 (SE, 4.62; P = .053) at 180 and 365 days, respectively, after allo-HCT. Similar results were found across the physical, social, and emotional HRQoL domains with mixed-effects models after adjustment of demographic and medical variables. In addition to the alleviation of clinical manifestations of SCD, these patients demonstrated significant improvement in most aspects of HRQoL by 1 year after allo-HCT. These data represent the trajectory of HRQoL during the initial year of follow-up within this population and should be integrated into the decision-making process when considering allo-HCT in patients with SCD.

The effectiveness of exercise interventions for improving health-related quality of life from diagnosis through active cancer treatment.

To evaluate the effectiveness of exercise interventions on overall health-related quality of life (HRQOL) and its domains among adults scheduled to, or actively undergoing, cancer treatment. 11 electronic databases were searched through November 2011. In addition, the authors searched PubMed's related article feature, trial registries, and reference lists of included trials and related reviews. 56 trials with 4,826 participants met the inclusion criteria. At 12 weeks, people exposed to exercise interventions had greater improvement in overall HRQOL, physical functioning, role functioning, social functioning, and fatigue. Improvement in HRQOL was associated with moderate-to-vigorous intensity exercise interventions. Exercise can be a useful tool for managing HRQOL and HRQOL domains for people scheduled to, or actively undergoing, cancer treatment. More methodologically rigorous trials are needed to examine the attributes of exercise programs most effective for improving HRQOL. Evidence from this review supports the incorporation of exercise programs of moderate-to-vigorous intensity for the management of HRQOL among people scheduled to, or actively undergoing, cancer treatment into clinical guidelines through the Oncology Nursing Society's Putting Evidence Into Practice resources.

Are exercise programs effective for improving health-related quality of life among cancer survivors? A systematic review and meta-analysis.

To evaluate the effectiveness of exercise interventions on overall health-related quality of life (HRQOL) and its domains among cancer survivors who have completed primary treatment. 11 electronic databases were searched from inception (dates varied) to October 2011. The authors also identified eligible trials through a search of additional sources. 40 trials with 3,694 participants met the inclusion criteria. At 12 weeks, cancer survivors exposed to exercise interventions had greater positive improvement in overall HRQOL (standardized mean difference [SMD] 0.48; 95% confidence interval [CI] [0.16, 0.81]), emotional well-being (SMD 0.33; 95% CI [0.05, 0.61]), and social functioning (SMD 0.45; 95% CI [0.02, 0.87]); and had a significant reduction in anxiety (SMD -0.26; 95% CI [-0.44, -0.07]) and fatigue (SMD -0.82; 95% CI [-1.5, -0.14]). Exercise programs have a beneficial effect on HRQOL and most of its domains and can be integrated into the management plans for cancer survivors who have completed treatment. Future research is needed to help understand specific attributes of exercise programs that are beneficial for improving HRQOL within and across cancer types. Evidence presented in this review supports the inclusion of exercise programs in clinical guidelines for the management of cancer survivors who have completed treatment, such as the Oncology Nursing Society's Putting Evidence Into Practice resource.

Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial

In the AFFIRM trial of patients with metastatic castration-resistant prostate cancer after progression with docetaxel treatment, enzalutamide significantly increased overall survival compared with placebo. Here we present the prospectively defined analyses of some secondary endpoints, including occurrence of skeletal-related events, measures of pain control, and patient-reported health-related quality of life (HRQoL). In this phase 3, double-blind trial, patients were randomly assigned (2:1) to receive enzalutamide 160 mg/day or placebo orally, stratified by ECOG baseline performance status (0 or 1 vs 2) and mean pain score (Brief Pain Inventory-Short Form [BPI-SF] question 3 worst pain, score ≤3 vs ≥4). Secondary endpoints were time to first skeletal-related event (defined as radiation therapy or surgery to bone); change from baseline to week 13 in pain severity and interference; pain palliation and progression at week 13; time to pain progression; overall improvement in HRQoL; improvements in HRQoL domains; and time to HRQoL deterioration. Analysis was done on the intention-to-treat population for each endpoint. AFFIRM is registered with ClinicalTrials.gov, number NCT00974311. Median time to first skeletal-related event in the enzalutamide (n=800) and placebo (n=399) groups was 16·7 months (95% CI 14·6 to 19·1) and 13·3 months (95% CI 9·9 to not yet reached), respectively (hazard ratio [HR] 0·69 [95% CI 0·57-0·84]; p=0·0001). Pain progression at week 13 occurred in 174 (28%) of 625 evaluable patients in the enzalutamide group versus 101 (39%) of 259 patients in the placebo group (difference -11·2%, 95% CI -18·1 to -4·3; p=0·0018). Median time to pain progression was not yet reached in the enzalutamide group (95% CI not yet reached to not yet reached) versus 13·8 (13·8 to not yet reached) months in the placebo group (HR 0·56 [95% CI 0·41 to 0·78]; p=0·0004). Mean treatment effects for pain severity (mean change from baseline in the enzalutamide group -0·15, 95% CI -0·28 to -0·02, vs placebo 0·50, 0·29 to 0·70; difference -0·65, 95% CI -0·89 to -0·41; p<0·0001) and interference (-0·01, -0·18 to 0·16, vs 0·74, 0·47 to 1·00; respectively, difference -0·74, 95% -1·06 to -0·43; p<0·0001) were significantly better with enzalutamide than with placebo. 22 (45%) of 49 evaluable patients in the enzalutamide group reported pain palliation at week 13 versus one (7%) of 15 in the placebo group (difference 38·2%, 95% CI 19·4-57·0; p=0·0079). Overall improvement in HRQoL was reported in more patients receiving enzalutamide (275 [42%] of 652) than in those receiving placebo (36 [15%] of 248; p<0·0001). Patients in the enzalutamide group had longer median time to HRQoL deterioration than did those in the placebo group (9·0 months, 95% CI 8·3-11·1, vs 3·7 months, 95% CI 3·0-4·2; HR 0·45, 95% CI 0·37-0·55; p<0·0001) in risk of deterioration. Our results show that, in addition to improving overall survival, enzalutamide improves wellbeing and everyday functioning of patients with metastatic castration-resistant prostate cancer. Astellas Pharma and Medivation.